User Manual For EM 200 - v2021.C03

Download as pdf or txt
Download as pdf or txt
You are on page 1of 478

User Manual

for

EM 200
R

Document Version: 2021.C03


Date: August 11, 2021

Transasia Bio-medicals Limited, Transasia House, 8 Chandivali Studio Road,


Andheri (East), Mumbai-400072, India
EM 200
Fully Automated Clinical Chemistry Analyzer

The analyzer is a random access, discrete, patient prioritized, fully


automated clinical chemistry analyzer designed to meet the needs
of modern clinical laboratories in mind for high throughput.

Once programmed, it is a walk-away system. The analyzer features


are user-friendly with minimum operator intervention. It is a highly
sophisticated system and therefore it is of utmost importance that
the operator and service personnel read the instructions and
becomes familiar with the operation theory.
Legal Information

All rights are reserved by manufacturer of this product.

Manufacturer is the copyright owner of this document.

The contents of this document are subject to change without prior notice and without legal
obligation.

This document and the information herein are provided for the sole use of the intended recipient(s)
and for information purposes only.

This document contains contents which are the confidential and proprietary information of the
manufacturer.

This document can not be modified, reproduced, translated or transmitted in any form or by any
means for any purpose, without prior written permission from the manufacturer.

No part of this document can be copied or reprinted, in whole or in part, without prior written
permission from the manufacturer.
Document Conventions
Before reading the manual, please get familiarized with the following icons used in this manual.

Icons Warnings

Bio-hazard

Electric shock

High temperature

Warning and caution

Note, usage, tips and additional information

Injury

Information or note related to Closed System


Contents 5

Table of Contents

Foreword 12

Part I System Overview 1-2


1 Introduction
................................................................................................................................ 1-2
What the..........................................................................................................................................................
system does 1-3
Basic principles
.......................................................................................................................................................... 1-3
2 A first
................................................................................................................................
look at the analyzer 1-5
Analyzer.......................................................................................................................................................... 1-5
Data station
.......................................................................................................................................................... 1-6
Host .......................................................................................................................................................... 1-7
3 System
................................................................................................................................
description 1-8
Panels and
..........................................................................................................................................................
labels 1-8
Front.........................................................................................................................................................
view 1-8
Right.........................................................................................................................................................
side view 1-9
Left.........................................................................................................................................................
side view 1-10
Modules..........................................................................................................................................................
and m ain com ponents 1-10
Functional
.........................................................................................................................................................
system 1-11
Sample and .........................................................................................................................................
Reagent Pipette Unit (SRPT) 1-11
Sample Barcode .....................................................................................................................................
Reader 1-11
Auto Sampler .........................................................................................................................................
Unit (ASP) 1-13
Reagent Tray .........................................................................................................................................
(RGT) 1-14
Reagent Bar .....................................................................................................................................
Code Reader 1-14
RGT Cooling .....................................................................................................................................
Unit 1-14
Pipette Pump .........................................................................................................................................
Assembly 1-15
Mixture Stirrer .........................................................................................................................................
Unit 1-16
Cuvette Rinsing .........................................................................................................................................
Unit (CRU) 1-16
Reaction Tray .........................................................................................................................................
(RCT) 1-18
Photometer .........................................................................................................................................
Unit 1-19
Liquid Level .........................................................................................................................................
Sensing for Cans (Float Sensors) 1-20
Ion Selective .........................................................................................................................................
Electrode (ISE) 1-20
4 Overview
................................................................................................................................
of user tasks 1-22
Daily routine
.......................................................................................................................................................... 1-22
System
.........................................................................................................................................................
Water Can and Waste Can 1-22
Cleaning
.........................................................................................................................................................
Can 1-22
ISE Unit
......................................................................................................................................................... 1-22
Preparation
.........................................................................................................................................................
of tank solution 1-23
Cleaning..........................................................................................................................................................
the instrum ent externally 1-24

Part II System Installation 2-2


1 Safety
................................................................................................................................
Instructions 2-2
2 Pre-installation
................................................................................................................................ 2-3
Laboratory..........................................................................................................................................................
cleanliness (practice) 2-3
Electrical..........................................................................................................................................................
requirem ents 2-3
Floor requirem
..........................................................................................................................................................
ents 2-4
Room lighting
.......................................................................................................................................................... 2-5
External interferences
.......................................................................................................................................................... 2-5
Room tem ..........................................................................................................................................................
perature and hum idity 2-5
Proper ventilation
.......................................................................................................................................................... 2-5
3 Installation
................................................................................................................................ 2-5
Recieving
..........................................................................................................................................................
Inform ation 2-6
Receiving
.........................................................................................................................................................
Instructions 2-6

EM 200
6 Contents

.........................................................................................................................................................
Warranty Information 2-6
Unpacking ..........................................................................................................................................................
the analyzer 2-7
Accessories..........................................................................................................................................................
checklist 2-8
Installing
..........................................................................................................................................................
the com ponents of analyzer 2-12
Sample
.........................................................................................................................................................
Tray and the Reagent Tray 2-12
Installing
.........................................................................................................................................................
DI Water, Cleaning, Bio-hazardous and Waste Cans 2-14
Connecting
.........................................................................................................................................................
communication cable betw een Computer and Analyzer 2-15
Printer
.........................................................................................................................................................
Installation (DeskJet / Laser) 2-16
Test.........................................................................................................................................................
Loader Device Connecting to USB on analyzer PC 2-16

Part III Software Installation 3-2


1 Safety
................................................................................................................................
Instructions 3-2
2 Pre-requisites
................................................................................................................................ 3-2
System Configuration
.......................................................................................................................................................... 3-2
PC Settings
..........................................................................................................................................................
required for Window s XP 3-3
Regional..........................................................................................................................................................
and Language Settings for Window s XP 3-3
PC Settings
..........................................................................................................................................................
required for Window s 7 3-5
Regional..........................................................................................................................................................
and Language Settings for Window s 7 3-9
PC Settings
..........................................................................................................................................................
required for Window s 10 3-13
Regional
..........................................................................................................................................................
and Language settings for Window s 10 3-17
Test Loader
..........................................................................................................................................................
Device 3-21
3 Software
................................................................................................................................
Installation Procedure 3-21
Installing
..........................................................................................................................................................
MultiXL 3-22
Installating
..........................................................................................................................................................
Database 3-30
Installing
.........................................................................................................................................................
Blank Database 3-31
Installing
..........................................................................................................................................................
Team View er 3-34
Upgrading..........................................................................................................................................................
MultiXL Softw are 3-36
Upgrade
.........................................................................................................................................................
Softw are 3-37
Upgrade
.........................................................................................................................................................
Database 3-38
Database ..........................................................................................................................................................
Utility Options 3-41
Database
.........................................................................................................................................................
Backup 3-41
Change
.........................................................................................................................................................
Database 3-43
Restore
.........................................................................................................................................................
Archive Database 3-47
Taking
.........................................................................................................................................................
Diagnosis Backup 3-48
Accessing..........................................................................................................................................................
MultiXL Softw are 3-48

Part IV Saftey Information 4-2


1 Safety
................................................................................................................................
Symbols 4-2
2 Warning
................................................................................................................................
Labels 4-2
3 Saftey
................................................................................................................................
Precautions 4-3

Part V Technical Specification 5-2


1 General
................................................................................................................................
specification 5-2
2 Sampling
................................................................................................................................
unit 5-3
3 Reagent
................................................................................................................................
unit 5-5
4 Reaction
................................................................................................................................
unit 5-5
5 Optical
................................................................................................................................
absorption measurement unit 5-6
6 Control
................................................................................................................................
unit 5-7
7 Data
................................................................................................................................
processing 5-7
8 Ion................................................................................................................................
selective electrodes (ISE) 5-8
9 Installation
................................................................................................................................
Condition 5-9

EM 200
Contents 7

................................................................................................................................
10 Computer Specification 5-9

Part VI User Interface 6-2


1 A first
................................................................................................................................
look at the user interface 6-2
2 Main
................................................................................................................................
menu layout 6-4
3 Screens
................................................................................................................................ 6-5
Patient Entry
.......................................................................................................................................................... 6-6
Sample .........................................................................................................................................................
Definition Parameters 6-7
Clear.........................................................................................................................................................
Schedule 6-9
Work .........................................................................................................................................................
List 6-10
Copy .........................................................................................................................................................
Tests 6-11
Mask .........................................................................................................................................................
Tests 6-12
Dow.........................................................................................................................................................
nload Samples from LIS 6-13
Patient Definition
.........................................................................................................................................
Parameters 6-14
CEC......................................................................................................................................................... 6-15
Schedule CEC ......................................................................................................................................... 6-16
Clear Schedule .........................................................................................................................................
CEC 6-17
Edit ......................................................................................................................................... 6-17
Test Param
..........................................................................................................................................................
eters 6-18
Test.........................................................................................................................................................
Details 6-19
Test Definition .........................................................................................................................................
Parameters 6-21
Auto Rerun ......................................................................................................................................... 6-29
Copy Test......................................................................................................................................... 6-30
Upload and .........................................................................................................................................
Dow nload Tests 6-30
Initialize Tests......................................................................................................................................... 6-32
Special Diluent ......................................................................................................................................... 6-32
Test Specific .........................................................................................................................................
Special Diluent 6-32
Cuvette Wash ......................................................................................................................................... 6-36
Online Calibration
......................................................................................................................................... 6-37
Set Online.........................................................................................................................................
Calibration 6-37
Warn After ......................................................................................................................................... 6-38
Test.........................................................................................................................................................
Volumes 6-38
Sample Volumes .........................................................................................................................................
Parameters 6-39
Reagent Volume .........................................................................................................................................
and Stirrer Speed 6-40
Copy Volume ......................................................................................................................................... 6-40
Apply Normal .........................................................................................................................................
Dilution Ratio of Sample 6-41
Reference
.........................................................................................................................................................
Ranges 6-41
Copy Reference .........................................................................................................................................
Range 6-43
View Reference .........................................................................................................................................
Range 6-43
Profiles/Calc
.......................................................................................................................................................... 6-43
Profiles
......................................................................................................................................................... 6-43
Calculated
.........................................................................................................................................................
Items 6-44
QC/Calibration
.......................................................................................................................................................... 6-46
Schedule
.........................................................................................................................................................
QC/Calibration 6-47
Scheduling.........................................................................................................................................
Standard 6-47
Scheduling.........................................................................................................................................
Control 6-50
Scheduling.........................................................................................................................................
Blank 6-53
Scheduling.........................................................................................................................................
Calibrator 6-55
Calibration
......................................................................................................................................................... 6-58
QC Data
......................................................................................................................................................... 6-63
Tw in.........................................................................................................................................................
Plot 6-70
QC Graph
......................................................................................................................................................... 6-73
Consum..........................................................................................................................................................
ables 6-75
Upload
.........................................................................................................................................................
and Dow nload 6-89
Status Monitor
.......................................................................................................................................................... 6-92
Sample
.........................................................................................................................................................
Tray 6-94

EM 200
8 Contents

Sample Status .........................................................................................................................................


Indicators 6-94
Reagent
.........................................................................................................................................................
Tray 6-95
Volume Scan ......................................................................................................................................... 6-96
Reaction
.........................................................................................................................................................
Curve 6-96
Barcode
.........................................................................................................................................................
Scan 6-97
Pre-Run
.........................................................................................................................................................
Options 6-100
Run.........................................................................................................................................................
Options 6-105
Work
.........................................................................................................................................................
List 6-105
Add.........................................................................................................................................................
Sample and Reagent (Barcoded) 6-108
ISE.........................................................................................................................................................
Pack 6-111
Refresh
.........................................................................................................................................................
Position 6-112
Scan
.........................................................................................................................................................
Pack 6-112
Online
.........................................................................................................................................................
Calibration 6-115
Search.......................................................................................................................................................... 6-119
Patient/Samples
......................................................................................................................................................... 6-120
Patient
.........................................................................................................................................................
Results 6-121
Calib/Control
.........................................................................................................................................................
Results 6-122
Consumables
......................................................................................................................................................... 6-123
Tests
......................................................................................................................................................... 6-124
Reports .......................................................................................................................................................... 6-125
Patient
.........................................................................................................................................................
Reports 6-126
Result
.........................................................................................................................................................
Reprint 6-134
Test
.........................................................................................................................................................
Statistics 6-136
Calibration
.........................................................................................................................................................
Trace 6-138
Calibration
.........................................................................................................................................................
Monitor 6-140
Error
.........................................................................................................................................................
Log 6-141
Reaction
.........................................................................................................................................................
Curve 6-142
Other
......................................................................................................................................................... 6-145
Master.......................................................................................................................................................... 6-149
Area
......................................................................................................................................................... 6-150
Doctor
......................................................................................................................................................... 6-150
Analyst
......................................................................................................................................................... 6-151
Laboratory
......................................................................................................................................................... 6-152
Mfg......................................................................................................................................................... 6-153
Reference
.........................................................................................................................................................
Range 6-154
Unit
......................................................................................................................................................... 6-155
Calculation
.........................................................................................................................................................
Formula 6-156
Instrument
......................................................................................................................................................... 6-157
Unit
.........................................................................................................................................................
Conversion 6-158
Utility .......................................................................................................................................................... 6-162
Reagent
.........................................................................................................................................................
Position 6-162
Transfer
.........................................................................................................................................................
To Tube 6-164
Backup
......................................................................................................................................................... 6-167
Backup Operations
......................................................................................................................................... 6-168
Copy Data .........................................................................................................................................
to External Storage Device 6-169
System Backup .........................................................................................................................................
Restore 6-170
Offline
.........................................................................................................................................................
Results 6-170
Recalculate
......................................................................................................................................................... 6-172
Service..........................................................................................................................................................
Check 6-173
Maintenance
.......................................................................................................................................................... 6-182
Maintenance
......................................................................................................................................................... 6-184
Span (Auto .........................................................................................................................................
and Manual) 6-184
Wash ......................................................................................................................................... 6-185
Dead Volume .........................................................................................................................................
Calibration 6-188
ISE Unit ......................................................................................................................................... 6-190
ISE Command .....................................................................................................................................
Buttons 6-190
Auto Maintenance
......................................................................................................................................... 6-195
Cell.........................................................................................................................................................
Blank 6-197

EM 200
Contents 9

.........................................................................................................................................................
Maintenance Log 6-200
Settings
.......................................................................................................................................................... 6-201
System
.........................................................................................................................................................
Parameters 6-201
Carryover
.........................................................................................................................................................
Pairs 6-206
Test
.........................................................................................................................................................
Sequence 6-208
Test Display .........................................................................................................................................
Sequence 6-209
Test Process .........................................................................................................................................
Sequence 6-209
Print Sequence.........................................................................................................................................
For Patient Reports 6-211
Profile Sequence
.........................................................................................................................................
For Patient Reports 6-212
Re-run
.........................................................................................................................................................
Flags 6-213
User
.........................................................................................................................................................
Rights 6-213
Host
.........................................................................................................................................................
Settings 6-214
Send Patient .........................................................................................................................................
Results to Host 6-216
Send Control .........................................................................................................................................
Results to Host 6-216
Schedule.........................................................................................................................................
Test Again 6-216
Send Sample .........................................................................................................................................
Position 6-216
Query Sample .........................................................................................................................................
at a time 6-216
Checksum ......................................................................................................................................... 6-217
Send Limit .........................................................................................................................................
Values for flagged Results 6-217
Hibernate/Wake-up
.......................................................................................................................................................... 6-217
Hibernate
......................................................................................................................................................... 6-217
Wake-up
......................................................................................................................................................... 6-218
Archive.......................................................................................................................................................... 6-218
Archiving
.........................................................................................................................................................
Data 6-219
View
.........................................................................................................................................................
ing Archived Data 6-221
Observations
......................................................................................................................................................... 6-223
Shut Dow
..........................................................................................................................................................
n 6-224
Shut
.........................................................................................................................................................
Dow n 6-224
Water
.........................................................................................................................................................
Save and Shut Dow n 6-225
Maintenance
.........................................................................................................................................................
and Shut Dow n 6-225
Master..........................................................................................................................................................
Calibration 6-225

Part VII Operation 7-2


1 Sequence
................................................................................................................................
of operation 7-2
2 Measurement
................................................................................................................................
operation table 7-2
3 Daily
................................................................................................................................
start-up 7-4
Verifying..........................................................................................................................................................
system resources 7-4
Starting up
..........................................................................................................................................................
and logging on to the system 7-6
Defining ..........................................................................................................................................................
required consum ables 7-7
Preparing ..........................................................................................................................................................
Sam ples and Reagents 7-7
Defining ..........................................................................................................................................................
sam ples and reagents 7-9
Defining
.........................................................................................................................................................
Samples 7-10
Barcoded ......................................................................................................................................... 7-10
Non-Barcoded ......................................................................................................................................... 7-11
Defining
.........................................................................................................................................................
Reagents 7-11
Barcoded ......................................................................................................................................... 7-18
Non-Barcoded ......................................................................................................................................... 7-20
4 Daily
................................................................................................................................
routine 7-22
Starting..........................................................................................................................................................
analysis 7-22
Interruption
..........................................................................................................................................................
and resum ption of m esurm ent 7-25
User activities
..........................................................................................................................................................
during run 7-26
Self activities
..........................................................................................................................................................
during run 7-26
5 End
................................................................................................................................
of day task 7-29

Part VIII Error Handling 8-2

EM 200
10 Contents

1 List................................................................................................................................
of Errors 8-2

Part IX Configuration 9-2


1 Login
................................................................................................................................
and password recovery 9-2
2 Setting
................................................................................................................................
UI language 9-3
3 Setting
................................................................................................................................
test sequence 9-3
4 Access
................................................................................................................................
control 9-4
To create..........................................................................................................................................................
new user login 9-4
To provide
..........................................................................................................................................................
access rights to existing user 9-5
To change..........................................................................................................................................................
the user ID passw ord 9-6
5 Connection
................................................................................................................................
to Host PC 9-7
In peer to
..........................................................................................................................................................
peer netw ork 9-8
In LAN (Local
..........................................................................................................................................................
Area Netw ork) 9-9
6 Entering
................................................................................................................................
the master details 9-10
Add area
.......................................................................................................................................................... 9-10
Add doctor
.......................................................................................................................................................... 9-11
Add analyst
.......................................................................................................................................................... 9-12
Add laboratory
.......................................................................................................................................................... 9-12
Add m anufacturer
.......................................................................................................................................................... 9-13
Add reference
..........................................................................................................................................................
range 9-14
Add unit.......................................................................................................................................................... 9-14
Add calculation
..........................................................................................................................................................
form ula 9-15
Add instrum
..........................................................................................................................................................
ent 9-16
7 Archive
................................................................................................................................
Data 9-17
Archiving
..........................................................................................................................................................
Data 9-18
View ing..........................................................................................................................................................
Archived Data 9-19
Observations
.......................................................................................................................................................... 9-21
8 Create
................................................................................................................................
profile 9-22
Add profile
.......................................................................................................................................................... 9-22
Delete profile
.......................................................................................................................................................... 9-22

Part X Result Flags 10-2


1 Flag
................................................................................................................................
List 10-2

Part XI Maintenance 11-2


1 Daily
................................................................................................................................
Maintenance 11-2
2 Weekly
................................................................................................................................
Maintenance 11-3
3 Quarterly
................................................................................................................................
Maintenance 11-4
4 Annual
................................................................................................................................
Maintenance 11-5
5 Replacement
................................................................................................................................
Schedule for Spares and Consumable 11-6
6 Preventative
................................................................................................................................
Maintenance 11-6
Inform ation
..........................................................................................................................................................
Requested by Our Custom er Service Departm ent 11-7
Malfunction
..........................................................................................................................................................
at the Tim e of Operation 11-7
Anom alous
..........................................................................................................................................................
Measurem ent Results 11-8
Check for
..........................................................................................................................................................
Preparation of Reagent, Calibrator or QC Sam ple 11-8
High Resultant
..........................................................................................................................................................
Values from a Specific Method for all Sam ples 11-9
Low Resultant
..........................................................................................................................................................
Values from a Specific Method for all Sam ples 11-9
Random..........................................................................................................................................................
ly Derived Erroneous Measurem ent Results 11-10
Anom alous
..........................................................................................................................................................
Resultant Values from all Methods for a Sam ple 11-10

Part XII ISE Measurment (Optional) 12-2

EM 200
Contents 11

................................................................................................................................
1 Technical Specification 12-3
2 Measurement
................................................................................................................................
Theory 12-4
3 Electrodes
................................................................................................................................
and Reagents 12-5
4 Urine
................................................................................................................................
ISE Dilution Rerun 12-5
5 Storage
................................................................................................................................
and Usage of the Reagents 12-5
6 Turning
................................................................................................................................
Off the Power 12-6
7 Shutdown
................................................................................................................................
Procedure 12-6
8 ISE
................................................................................................................................
Calibration 12-7
9 Maintenance
................................................................................................................................
Schedule 12-9
10 Troubleshooting
................................................................................................................................ 12-9
11 Installing
................................................................................................................................
New Reagent Pack 12-12
12 Error
................................................................................................................................
Messages 12-13

EM 200
12 Foreword

Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an
instructional aide to provide a reference for easy operation and general maintenance of this
analyzer. It contains detailed description of the analyzer features and specifications. The analyzer
is used with operational PC and Printer, and can interact with the host computer. The operational
PC consists of the application software for the user to operate the analyzer.

All the samples and reagents for measurements including samples obtained from patients are
controlled by barcodes enabling the analyzer to perform the entire process of the analysis
automatically.

Use of the analyzer with proper knowledge will ensure quality test results and trouble free analyzer
operation and performance.

This operation manual is prepared based on the assumption that the user has knowledge of clinical
chemistry.

Before operating the analyzer, user should:

1. Read and understand this manual.

2. Be trained by authorized person.

3. Be familiar with the operation of the analyzer

Keep this manual in an easily accessible place.

EM 200
Part

I
1-2 System Overview

1 System Overview
This section provides an overview of the analyzer and its main features.

See the following section for more details:

Introduction

A first look at the analyzer

System description

Overview of the user tasks

1.1 Introduction
It is an advanced integrated system for diagnostic clinical chemistry testing.

It is a random access, discrete, patient prioritized, fully automated clinical chemistry analyzer
designed to meet the needs of modern clinical laboratories in mind for high throughput. Once
programmed, it is a walk-away system.
This analyzer is In-Vitro Diagnostics (IVD) equipment intended to use in pathological laboratories and
hospitals.
Random sample access, innovative robotics, and an advanced user interface, using windows
embedded operating system, optimize time management and streamline work flow.

The Ion Selective Electrode (ISE) module allows the determination of sodium, potassium, chloride,
and lithium ions in parallel with absorbance and photometric measurements.

Barcode identification system is provided for both, reagents and samples.

The high performance, flexibility, and versatility of the analyzer make this system suitable as a
routine analyzer as well as a dedicated instrument for specific tasks.

It is a highly sophisticated system and therefore it is of utmost importance that the operator and
service personnel read the instructions and becomes familiar with the operation theory.

1 Data Station

2 Analyzer

EM 200
System Overview 1-3

1.1.1 What the system does


The system consists of the analyzer and the data station.
The analyzer runs tests on samples, calibrators, and controls, and produces the results. The data
station analyzes and further processes the results.
Here are just some of the actions the system performs automatically.
Reads the bar-codes on reagent bottles, samples tubes and displays the related information on

the screen.

Performs washing and cleaning cycles to minimize carry-over between tests.

Calculates and ensures the integrity of the result, generating flags for suspect ones.

Keeps track of all samples, tests, and test’s schedule on the instrument.

Collates results into reports for printing or result transmission to another computer system.

Stores the results of each patient and test in a database.

Perform auto-rerun of samples.

Automatic daily maintenance.

1.1.2 Basic principles


The analyzer is an automated clinical biochemistry analyzer based on the principle of photometry, it
measures light transmittance at various wavelengths White light as we see it is actually composed of
several colors. This becomes evident, when we pass a beam of white light through a prism. If the light
emerging from the prism on the opposite side were allowed to fall on a screen, we would see a wide
spectrum of colors, beginning with red on the top and ending with violet at the bottom. The colors
visible in between are in the order of indigo, blue, green, yellow, and orange.

Incident or white light contains the entire spectrum, objects that appear colored, absorb light at a
particular wavelength and reflect others, thus giving different colors. That color is a function of its
wavelength.

Light having a wavelength of less than 400 nm is termed Ultraviolet, where as light having a
wavelength greater than 800 nm is described as Infrared, both ultraviolet and infrared lights are
invisible to the human eyes. Light corresponding to wavelengths between 400 nm and 800 nm is
visible to the human eye and is termed as Visible light.

EM 200
1-4 System Overview

Principles of Absorption Photometry

Beer’s Law
If light is allowed to pass through a colored solution, the solution will absorb some light while the rest
of it will be transmitted. The amount of light absorbed is proportional to the nature, concentration and
color of the solution. (Light absorbed Concentration of the solution).

Lambert’s Law
The light absorbed by the colored solution is directly proportional to the light path of the color solution
(diameter of the cuvette): that is if the cuvette diameter is doubled, the light absorbed will be doubled.

Since the total incident light = light absorbed + light transmitted, it follows that:

Therefore as the absorbed light (Absorbance) increases, the transmitted light will decrease.
As we increase the concentration of the colored solution, the light absorbed increases, and we find
that the transmittance varies inversely and logarithmically with concentration.

EM 200
System Overview 1-5

1.2 A first look at the analyzer


See the following section for more details:

Analyzer

Data Station

Host

1.2.1 Analyzer
The analyzer features user-friendly operation with minimum operator intervention.

The analyzer comprises of photometer and sophisticated robotics combined with an Operating
Console and Data Processing Unit (DPU). The DPU in the analyzer provides a schedule to the
analyzer, after executing the schedule as per the programmed sequence, the photometric results are
then sent to the analyzer’s computer connected to the analyzer where they are processed, stored
and then reported.

The robotics consists of Sample and Reagent arm (SRPT), Stirrer unit, Cuvette Rinsing Unit, Sample
tray, Reagent tray and Reaction tray.

Bar-code identification system is provided for both, reagents and samples.

The instrument carries out all tests automatically and is equipped with measuring modules for
absorbance photometry (Abs.) and ion-selective electrode measurements (ISE).

EM 200
1-6 System Overview

Access panels to work on the internal and external parts of the analyzer.

1 Left Side Panel


Power supply cable and Main or Primary switch (On/Off) [Not shown].

2 Front Panel
Dome cover (open upward) gives access to load samples and reagents.

3 Right Panel
Provides access to connectors of Waste Can, DI water Can, Cleaning Solution Can, Bio-
hazard Can, Float sensors.[Not shown]
Secondary ON/OFF switch [Not shown]

4 Status indicator
Indicates analyzer's ON/OFF status. Light turns to red when secondary switch is OFF, else
display as blue.

1.2.2 Data station


The data station comprises the elements shown below.

EM 200
System Overview 1-7

1 Monitor

2 Keyboard

3 Central processing unit

4 Mouse

5 Printer

1.2.3 Host
A host is a computer connected to the analyzer PC.

The clinical laboratory instruments under consideration are those that measure one or more
parameters from one or more patient samples. Often they will be automated instruments that
measure many parameters from many patient samples. This instrument output may include patient
results, quality control results, and other related information.

The computer systems considered here are those that are configured to accept instrument results for
further processing, storage, reporting, or manipulation.

ASTM HOST protocol enables any two such systems to establish a logical link for communicating
text to send result, request, or demographic information in a standard and interpretable form.

Typically, Host software communicating with Clinical Laboratory Instruments is considered here as
Analyzer PC and the computer system considered here is as Laboratory Information Management
System (LIMS/LIS PC).

MultiXL communicates with LIS through Serial Port or TCP/IP. Separate serial port is required to
enable the communication with LIS through serial cable. To enable communication through TCP/IP,
the analyzer PC should be connected to local network.

EM 200
1-8 System Overview

1.3 System description


This section gives an overview of the hardware and provides more detailed information about the main
functional systems.

See the following section for more details:

Panels and labels

Modules and main components

1.3.1 Panels and labels


See the following section for more details:

Front view

Right side view

Left side view

1.3.1.1 Front view

Access panels to work on the internal and external parts of the analyzer.

EM 200
System Overview 1-9

1 Cover (Dome)
Provide access to sample tray and reagent tray.

2 Status Indicator
Indicates the analyzer's current state.

1.3.1.2 Right side view

Access panels to work on the internal and external parts of the analyzer.

1 Connectors
Connector for Waste Can, Bio-hazard waste Can, Cleaning solution and DI water Can with
float switch sensors

2 Secondary ON/OFF Switch


Secondary switch for shutting down the analyzer. except ISE module.

EM 200
1-10 System Overview

1.3.1.3 Left side view

Access panels to work on the internal and external parts of the analyzer.

1 Primary ON/OFF Switch


Secondary switch for shutting down the analyzer including ISE module.

1.3.2 Modules and main components


Following figure shows how the modules and components are arranged in the instrument.

EM 200
System Overview 1-11

Modules and main components

1 Sample and Reagent Pipette Unit


(SRPT)

2 Stirrer

3 Auto Sampler Unit (ASP)

4 Cuvette Rinsing Unit (CRU)

5 Reaction Cuvette Tray (RCT)

6 Reagent Tray (RGT)

1.3.2.1 Functional system


See the following section for more details:

Sample and reagent pipette unit

Sample tray

Reagent tray

Pipette pump assembly

Mixture or stirrer unit

Cuvette rinsing unit

Reaction tray

Photometer unit

Liquid level sensing for cans

Ion selective electrodes (ISE)

1.3.2.1.1 Sample and Reagent Pipette Unit (SRPT)

The Sample & Reagent Pipette Unit (SRPT) consists of a probe (nozzle), up-and-down movement
mechanism, rotating mechanism, liquid level sensor and nozzle down limit sensor.

The SRPT is connected to the syringe pump for sample aspiration via PTFE tube. The sample or
reagent on the ASP unit or RGT tray is aspirated by the pipette and then dispensed into the cuvettes
(reaction cells) in the RCT unit. Probe has smooth finish surface from outside is passivated and
polished from inside to minimize any sample carry over. When an optional ISE unit is fitted and the
ISE measurement is performed, the SRPT aspirates sample for ISE measurement and dispenses it
into the sample port of the ISE unit.

EM 200
1-12 System Overview

Liquid Level Sensor (LLS)


When the tip of the nozzle reaches and touches the sample surface, the electrostatic capacitance of
the metallic nozzle varies. The variation of the capacitance is detected and consequently the level of
sample is detected.

Probe Down Limit Sensor


When the tip of probe hits the bottom during any of the downwards movement due to the obstruction,
the lower limit sensor detects that the tip of probe hits the bottom and stops its downward movement
(Vertical obstruction detection or VOD).

SRPT Washing Station


The wash station for the sample & reagent probe consists of a two position used as Drain
Position” (for internal cleaning of the probe) and as “Trough Position” (for external cleaning of the
probe). After the sample & reagent probe has dispensed sample & reagent 1 or reagent 2 into the
cuvette, the arm moves to the drain station where the chase volume is dispensed & then moves to
trough position where it is cleaned internally as well as externally using a jet of DI Water at approx.
40º C & 0.8 -1.2 bar pressure.

1.3.2.1.1.1 Sample Barcode Reader

The barcode reader reads barcode of the label affixed on the outer surface of the sample tube. When
the reader does not read the barcode even if the bar code label exists, the appropriate error message
is indicated.

The readable bar codes are as follows:

Symbol Valid character and symbol


NW-7 Numerals (0 – 9), symbols (-, $, /, +)
Code39 Numerals (0 – 9), alphabetical characters, symbols (-, space, $, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128: All ASCII code characters [numerals (0 – 9), alphabetical characters
Set A, Set B, Set C (uppercase/lowercase), symbols, control characters]

Resolution of the barcode label should be 0.25 mm. Length of the barcode should be 42 mm and
width should be 10 mm.

Number of digits should be between 3 to 18 but the combination of digit and type should be within the
specified length of the barcode label.

EM 200
System Overview 1-13

1.3.2.1.2 Auto Sampler Unit (ASP)

The auto sampler unit (ASP) consists of a removable turntable with sample tube adaptor and rotating
mechanism with a bar code reader for identifying samples.

The ASP tray can accommodates:

30 barcoded sample tubes of 5, 7, and 10 ml

9 non-barcoded cups of 2 ml

The types of usable sample tubes are shown below:

The sample is aspirated by the Sample & Reagent Pipette Unit (SRPT) and dispensed into cuvettes
of the Reaction Tray Unit (RCT).

The ASP tray of the analyzer consists of three rows:

Outer

Middle

Inner

The outer and middle row has total 30 positions that are used for placing Patient’s or Emergency
samples. Sample tubes as well as 2 ml cups could be placed in these two rows.

The inner row has 9 positions for placing Blank, Control, Standards and Calibrators. Patients and
Emergency samples can also be placed in these locations in 2 ml cups, if required. Only 2 ml
Sample cups or 500 µl STD cups can be placed in the positions marked as I1 to I9.

EM 200
1-14 System Overview

1.3.2.1.3 Reagent Tray (RGT)

The Reagent Unit (RGT) consists of reagent bottle tray, barcode reader, cooler, sensor and rotating
mechanism.

The reagent tray of the RGT can accommodate 50 Reagent bottles with big and small type of
containers.

The reagent tray rotates and the required reagent bottle is moved to the position where the reagent is
aspirated. At this position, the reagent is aspirated by the SRPT unit and then dispensed into
cuvettes in the RCT unit.

Type of Reagent Bottles

The reagent bottles are available in two types. The type of usable reagent bottles are shown below:

Big, (50 ml)

Small (20 ml for outer bottles).

The reagent bottles provided with the analyzer is shown below.

EM 200
System Overview 1-15

All bottles are screw capped to prevent evaporation of reagents while not in use. Total 50 bottles can
be placed (25 numbers of 50 ml and 25 numbers of 20 ml). Bar-code reader reads the bar-coded
labels on the reagent containers for identification.

1.3.2.1.3.1 Reagent Bar Code Reader

The barcode reader reads barcode of the label affixed on the outer surface of the reagent bottle. The
barcode reader used is Laser type reader. Resolution of the barcode label should be 0.25 mm. The
readable bar codes are as follows:

Symbol Valid character and symbol


ITF Numerals only (0 – 9)

1.3.2.1.3.2 RGT Cooling Unit

Even if the analyzer is turned off (by analyzer’s ON/OFF switch located on the right side of the
analyzer), the temperature inside the RGT unit is kept within the specified limits by the Peltier
element which is controlled by temperature controller.

1.3.2.1.4 Pipette Pump Assembly

There is one syringe pump of 500 µl capacity, common for both reagents as well as sample. The
syringe pump of the analyzer is a modular type by which it aspirates & dispenses volumes between
2 µl to 300 µl. Sample volumes can be increased in steps of 0.1µl. The syringe is located behind the
front plate of the analyzer and is connected to the probe via appropriate tubing.

The analyzer may have any one of the syringe type as shown below:

EM 200
1-16 System Overview

1.3.2.1.5 Mixture Stirrer Unit

The mixing stirrer unit (STIRRER) consists of the up-and-down mechanism and the paddle rotating
mechanism.

The sample and the primary reagent dispensed into the cuvettes are stirred by rotating the paddle at
predefined requested speed of high, low or medium. The paddle is washed in the STIRRER trough
with system water at 37 º C – 41 º C and pressure of 0.8-1.2 bar.

The secondary reagent dispensed into the cuvettes is stirred by rotating the paddle at predefined
speed of high, low or medium. The paddle is again washed in the STIRRER trough with system water
at 37 º C – 41 º C and pressure of 0.8-1.2 bar.

1.3.2.1.6 Cuvette Rinsing Unit (CRU)

The Cuvette Rinsing Unit (CRU) serves the purpose of washing the inner surface of the cuvettes in
which the measurement of specimen have been completed and allow them to be reused. The CRU
consists of 8 probes, probes 1 to 6 are in pairs (one for dispensing and the other one for aspirating),
followed by a single probe for final aspiration and the last probe attached with a drier serves the
purpose of drying the cuvettes.

The cuvette washing via the CRU takes place in 8 stages as described below:

EM 200
System Overview 1-17

Probe 1 – Aspirates the bio hazardous waste and dispenses cleaning solution.

Probe 2 to 6 – Aspirates the cuvette contents, and dispenses DI water.

Probe 7 – Aspirates the cuvette content.

Probe 8 – Dries the reaction cuvette.

EM 200
1-18 System Overview

1.3.2.1.7 Reaction Tray (RCT)

The reaction tray (RCT) consists of the cuvette ring set and rotating mechanism. RCT is provided with
45 hard glass cuvettes (5mm * 5mm) on its outer circumference and the temperature inside is
maintained at 37ºC (+/- 0.2ºC) constantly. The cuvettes are moved at 10-second step and a series of
process including dispensation, stirring, photometric measurement and washing will be performed.

EM 200
System Overview 1-19

To improve the efficiency of the photometer, the RCT tray will automatically
come to offset position (such that the beam falls in between two consecutive
cuvettes) on the following conditions:

After the end of batch run

When the batch run is manually terminated from Status Monitor by user

When the batch run terminated due to occurrence of any emergency error.

1.3.2.1.8 Photometer Unit

The photometer unit consists of the optical measurement system having narrow bandwidth,
wavelength specific filters with light source. The absorbance inside the cuvette is measured by using
a photometer.

Measurement is performed with any combinations of 2 wavelengths selected among the following 8
wavelengths:

340 nm, 405 nm, 505 nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm

The photometer consists of an illuminant (halogen lamp), lenses, optical filter and photoreceptor
(photodiode). The light passing through the cuvette (reaction mixture) is splitted by beam splitter,
which in turn passes through wavelength specific filter on to diode. This eliminates several optical
interferences and greatly improves the efficiency of the photometer.

EM 200
1-20 System Overview

1.3.2.1.9 Liquid Level Sensing for Cans (Float Sensors)

The Liquid Level Sensor are placed inside the respective Cans of DI water, Cleaning solution, Bio-
hazardous waste & normal waste Can. Accordingly, for DI water & cleaning solution, the float based
level sensors will sense the low level of DI water or cleaning solution & respective LED will lit on the
instrument with the beep sound.

Similarly, full levels are detected for both the waste can & respective LEDs are lit accordingly with
beep sound. All the LEDS are placed just near to the tube connection for the same cans.

1.3.2.1.10 Ion Selective Electrode (ISE)

ISE unit is placed inside the analyzer. To access the unit, open the cover provided on the analyzer.
See the following figure for more details.

The concentration of electrolyte (sodium: Na, potassium: K, chloride: Cl, lithium: Li) contained in
serum, plasma or (sodium: Na, potassium: K, chloride: Cl) urine is measured by the ion electrode of
the ISE unit. This unit is optionally supplied.

The ISE unit consists of ISE module, ion electrode, supply and drain pump.

1 CAL A Pump

2 CAL B Pump

3 Waste Pump

EM 200
System Overview 1-21

4 Electrodes

The concentration of the electrolyte (sodium: Na, potassium: K, chloride: Cl, lithium: Li) contained in
serum, plasma or (sodium: Na, potassium: K, chloride: Cl) urine is measured by the ion electrode of
the ISE unit that is placed on the left-hand side of the analyzer. This unit is optionally supplied.

The ISE unit consists of ISE module, ion electrode, supply and drain pump.

ISE module This module unit is fitted with electrodes (Na, K, Cl, Li & Reference)
and controls pumps, measurement of concentration by electrodes and
rinsing movement. Communication to the analyzer is carried out
through RS232C.
Ion electrode This unit consists of Na, K, Cl, Reference and Li electrodes.
The Reagent pack for Calibrant-A and Calibrant-B is placed on the top
cover. Dedicated wash solution are placed in the ASP unit and wash
solution is supplied by the SRPT in the same way as for the sample.
Supply pump These pumps are performs the infusing of Calibrant-A and Calibrant-B
into ISE module.
Drain pump This pump performs the transferring of liquid in ISE module.

The following solutions are required for the ISE unit:

Calibrant-A
Calibrant-A is used at the time of one-point calibration.
The one-point calibration is carried out at the same time when the Calibrant-A is dispensed to wash
electrodes every time the sample measurement is performed. 100µl of Calibrant-A is automatically
dispensed into the ISE unit every 30 minutes to prevent the electrode from drying during standby
cycle.

Calibrant-B
Calibrant-B is used at the time of two-point calibration.
The two-point calibration should be carried out at the beginning of the day and at least once every 8
hours or after completion of 50 samples.
The ISE Module dispenses 36 ΅l of Calibrant B and 95 µl of Calibrant A into the sample entry port in
every 30 minutes.

Cleaning Solution
The cleaning solution needs to be dispensed into the unit to avoid deposition of protein on the
electrodes.
As necessary, 500µl of the wash solution is dispensed into a sample cup and it is placed on position
of the ASP tray.
This function should be carried out twice a day, once in the beginning of the day before the
Calibration and at the end of day. When more than 50 samples of measurement are carried out,
washing must be carried out.

Diluent
The diluent is used to dilute urine to one-tenth in concentration. It is placed in a reagent bottle that is
placed in the RGT unit at the user defined position. The necessary volume for diluting one sample is
200µl. The dilution is carried out using a cuvette in the RCT unit and therefore one cycle of chemistry
analysis is allocated to this processing.

Sampling Volume at each Measurement

EM 200
1-22 System Overview

In the case of analytic Sample Volume for Serum 70 µl


measurement Sample Volume for Urine 140 µl
In the case of full calibration Calibrant-A: 180µl, Calibrant-B: 180µl
In the case of 1-point Calibrant-A: 180µl
calibration (Serum cycle)
In the case of 1-point Calibrant-B: 230µl
calibration (Urine cycle) Calibrant-A: 100µl

1.4 Overview of user tasks


This section tells you the necessary daily routine tasks to be performed before starting the
instrument for analysis.

See the following section for more details:

Daily routine

Cleaning the instrument externally

1.4.1 Daily routine


Routine tasks as follows:

System Water Can and Waste Can

Cleaning Can

ISE unit

Preparation of tank solution

1.4.1.1 System Water Can and Waste Can


Make sure that:

1. The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.

2. The Bio-waste Can must be emptied.

1.4.1.2 Cleaning Can

The cleaning solution Can is filled with wash solution.

1.4.1.3 ISE Unit


Flow of Liquids in ISE Tubing’s

If the ISE unit is installed in the system, make sure that the ISE tubing’s should be filled with CAL A
and CAL B solutions and air bubbles should not be present inside the tubes. The reagent pack
should have enough CAL A and CAL B content. For this, from the application software, in
Maintenance screen, send ISE Purge A and Purge B commands 3 - 4 times consecutively so as to
clear the path of CAL A and CAL B.

Verify that there should not be any bacterial growth near the electrode placement areas and also

EM 200
System Overview 1-23

near the inlet port of ISE Module.

Ensure that the following checks are performed before ISE measurement.

1. Before performing measurement with the ISE unit, confirm that Electrode unit (Na, K, Cl, Li
and Reference electrodes) whose term of validity is not expired is installed.
2. The Reagent Pack is filled with sufficient Calibrant-A and Calibrant-B solution.
3. Cleaning was carried out at the end of the last ISE measurement.
4. The Calibrant-A is flowing from the side of sample port by executing of ISE purge.
5. In the following cases, ISE purge should be carried out 5 times or more:
At the first measurement of ISE.
At the time of exchanging the ISE Reagent pack.
At the time of being pulled up the tube from the Calibrant-A.
Just after turning on the analyzer, 3-4 times of ISE purge should be carried out. All electrodes
should be fitted to the ISE module, otherwise the liquid of Calibrant-A is flooded into the inside
of analyzer. It may cause serious problem.

The analyzer should be kept ON (primary power-on) because 95 µl of Calibrant-A


and 36 µl of Calibrant-B is automatically dispensed into the ISE unit every 30
minutes to prevent the electrodes from drying; even under the sleep condition.

1.4.1.4 Preparation of tank solution


The external tanks of the system DI water, detergent, bio-hazardous waste, and diluted waste are to
be placed near the right-hand side or rear side of the analyzer and to be connected to the analyzer
with the corresponding tubes which includes float sensors.

Just before measurement, the external tanks of the system DI water and cleaning solution are filled
with the corresponding liquid, and the tanks of the bio-hazardous waste and diluted waste have to be
empty.

DI Water

Detergent solution

Bio-hazard

Diluted Waste

The DI water should have a resistivity of more than 1 Mega Ohm-cm (or conductivity less than 1µS/
cm). Also the pH of the DI Water should be maintained to 5.0 to 7.0.

Preparation of Detergent Solution

1. Fill the detergent solution can (given with the Accessories List) with 10 liter of DI water.

2. Pour the 100 ml concentrated solution into the can to prepare a 1% detergent solution.

3. Mix it well before use.

EM 200
1-24 System Overview

1.4.2 Cleaning the instrument externally


You can clean the instrument externally with a cloth and a soap solution with mild disinfectant, or a
solution of 70% ethanol.

Incorrect cleaning materials can damage the analyzer

Do not clean the instrument while it is switched on.


Do not use organic cleaning solvents (for example, petroleum, benzene, petrol or other
solvents) because they can damage cuvettes, tubing, and other plastic materials.
Do not use an alcohol solution with a concentration of greater than 70% alcohol, because this
may damage transparent viewing windows.
Do not use sodium hypochlorite solution because it causes corrosion on metal parts.

EM 200
Part

II
2-2 System Installation

2 System Installation
This section gives you the detailed explanation on installing analyzer.

See the following section for more details:

Pre-installation

Installation

Read the necessary general safety guidelines before installing the analyzer for the first
time. See Safety Instructions for more details.

2.1 Safety Instructions


Read the necessary general safety guidelines before installing the analyzer for the first
time.

Electrical safety:

The access to the conductive parts within the analyzer may cause serious
electric shock. When removing parts, make sure to shut off the main power
supply from the socket. Leave any maintenance and repair of electrical parts
inside the equipment to qualified service personnel.

General safety:

Only authorized service personnel should perform the installation process.

Keep the analyzer out of the rain and any other water splash.

Avoid areas that are adversely affected by atmospheric pressure, temperature,


humidity, ventilation, sunlight, dust, air containing salt or sulfur, etc.

Use level indicator for ensuring the machine is leveled properly.

Pay attention to inclination, vibration, shock (including shock during


transportation), etc.

Danger of explosion through sparks. Do not install the analyzer at the place
adjacent to the storage room of chemicals, or explosive material or the place
where any gas is likely to be generated.

Pay attention to frequency, voltage and permissible current (or power


consumption).

Connect the analyzer to the operational computer using accompanying USB


cable supplied with the analyzer. When other cable is used, this may cause the
analyzer to suffer from disturbing noise, exert an adverse effect on its
surroundings or get incorrect measurement results.

Check the power supply frequency, voltage and current capacity (power
consumption).

Ensure that the analyzer is correctly and well grounded.

EM 200
System Installation 2-3

Ensure that all the necessary electrical cables are correctly connected.

Check that the contact conditions of switches and indicators are appropriate and
that the analyzer is ready to be activated correctly. Extreme care must be taken
not to result in misdiagnosis or pose any danger to the analyzer or human body
when the analyzer in conjunction with other equipment.

2.2 Pre-installation
The proper location is an important consideration; a poor location can lead to malfunction of the
analyzer. To ensure the accuracy and precision of the analyzer, you must follow the pre-installation
requirements before installing the analyzer.

Read the environmental and electrical suggestions to ensure the accuracy and precision of the
analyzer.

See the following sections for more details:

Laboratory cleanliness (practice)

Electrical requirements

Floor requirements

Room lighting

External interferences

Room temperature and humidity

Proper ventilation

2.2.1 Laboratory cleanliness (practice)


The instrument and the surrounding area should be maintained clean and regularly decontaminated
to prevent contaminating yourself and others.
There should be no spillage of Serum, Reagents, Waste or DI water.

Make sure that no Reagents or Samples are placed on top of the analyzer or trolley as they could
spill causing a permanent damage to the analyzer.

2.2.2 Electrical requirements

A proper grounding is highly essential for safety and proper functioning of the
analyzer.

A proper grounding is highly essential for safety and proper functioning of the
analyzer.
Improper grounding the analyzer by passes important safety features and may
result in an electrical hazard.
Improper grounding to analyzer bypasses the important safety features and may
result in permanent damage to the analyzer that may void the warranty. It is
absolutely necessary to ensure proper grounding.

Voltage and frequency

EM 200
2-4 System Installation

Single-phase continuous stabilized AC 220 volts ± 10%, 50/60Hz or AC 110 volts ± 10%, 50/60Hz
supply.
The analyzer comes equipped with a three-pin power cord. The type of cord and plug depends on
the source voltage for the system

Grounding

It is absolutely necessary that the perfect grounding must be provided to the power source with all
applicable local requirement (only a certified grounded 3 pin power plug should be used).

Recommended earthing voltage between neutral and earth terminal is below


+3V.

Plug points

Four 5 ampere sockets must be available near the analyzer. (Four sockets are required, one each
for the analyzer, computer, monitor and printer).

It is recommended that two extra sockets be provided near the analyzer, for use by a measuring
equipment or engineering tool if required while servicing (Example Oscilloscope, Soldering iron
etc.).

Heavy-duty electrical devices like Air conditioners, refrigerators, ovens etc. should not be operated
on the same electrical lines as the analyzer

The 3 pin power cord plugs shipped with the analyzer, computer, printer and
monitor may not be compatible with the local electrical sockets of some
countries, you have to get these procured from the local market prior to the
installation.

2.2.3 Floor requirements

EM 200
System Installation 2-5

2.2.4 Room lighting


There should be sufficient room lighting, the lighting should be even, and there should be no shadow
areas, this problem can be eliminated by the use of multiple light sources from diagonally opposite
directions.

This will enable efficient operator use, and will give a clear visible access to the internal components
of the analyzer during operation and technical servicing.

2.2.5 External interferences


Heavy-duty electrical devices like air conditioners, refrigerators, ovens, centrifuges etc should
not be operated on the same electrical lines or in the close vicinity of the analyzer.

The room should be free of vibrations from heavy duty devices like centrifuges and
compressors.

The room should be free from strong magnetic fields caused by other medical equipment, like
CT Scans, MRI etc.

Mobile phones should not be operated close to the Analyzer

Verify and ensure a dust free environment for analyzer, this is a small but very important
consideration when installing the analyzer.

2.2.6 Room temperature and humidity


Measure the room temperature at different corners of the Laboratory. The recommended temperature
is 22 to 28°C with 40 to 80% humidity.

Room temperature should not vary more than 2°C per hour.

2.2.7 Proper ventilation


Make sure that there is at least 0.25 meters of un-used space around the instrument on all three
sides, to enable proper ventilation. Please do not put any stationery or any other item by which
operating the analyzer becomes difficult.

Please make sure that there is no direct air flow of air-conditioner on analyzer.

2.3 Installation
The analyzer should be installed by the trained service engineer.

The analyzer is fully inspected before leaving the factory and carefully packed to withstand shocks in
transit.

On receiving the analyzer, check the package externally; make sure that there is no external visible
damage to the shipping container if there is damage please make a note of it, if possible photograph
it and inform the manufacturer immediately. Verify with the invoice, if all the boxes have arrived.

In case of damage, the necessary procedures of claiming the insurance is


initiated at customer site.

EM 200
2-6 System Installation

See the following section for more details:

Receiving Information

Unpacking the Analyzer

Accessories Checklist

Installing the Component of the Analyzer

2.3.1 Recieving Information


The analyzer is thoroughly tested before shipment and is packed carefully to prevent damage during
shipping and handling.

This section describes you the basic guidelines or information on analyzer's receiving instructions
and warranty.

See the following link:

Receiving instructions

Warranty instructions

2.3.1.1 Receiving Instructions


Please follow these guidelines on receipt of the analyzer:

Ensure that the arrows on the sides of the packages are pointing up. If the arrows do not point
up, make a remark about this on the invoice copy.

Visually inspect the outside of the package for rips, dents, or possible shipping damage.
Document any sign of damage on the bill of landing, regardless of how insignificant it may
appear. This is to protect your interests.

Notify your service representative that the analyzer system and its components have arrived.
Wait for your local service representative to unpack the system and open the packages.

Follow the unpacking and storage instructions provided on the outside of the package. Special
requirements such as refrigeration are clearly marked on the outside of the cartons and will be
included in the unpacking instructions and pack inserts.

2.3.1.2 Warranty Information

All analyzers are warranted against defective materials or workmanship for a period of one year
commencing from the date of the shipment of the analyzer.
This warranty does not cover any defect, malfunction or damage due to:

Accident, neglect or willful mistreatment of the product.

Failure to use, operate, service, or maintain the product in accordance with the applicable
Operator Manual and Service Manual

Use of reagents or chemicals of corrosive nature, though the unit is an open system allowing
the use of any commercial reagents from any manufacturer that are meant for such an
automated clinical chemistry analyzer.

EM 200
System Installation 2-7

2.3.2 Unpacking the analyzer


Unpack the analyzer carefully; otherwise you may damage the accurately
adjusted optical, mechanical and electronic assemblies.

The analyzer is packed carefully to prevent any shipping damage. Upon arrival, inspect the packing
according to the list and notify the carrier of any apparent damage. Follow the steps to install the
analyzer:

1. Remove the front panel of the wooden box by loosening the bolts. The front panel
on the wooden box is marked.

2. Remove the top and side panels of the wooden box as a whole section by
loosening the bolts from the back panel side.

3. Remove the four “Z” brackets, which are holding the analyzer on the pallet.

The “Z” bracket and the footrest may support the entire weight of the
instrument. Cautiously open the bolts of the “Z” bracket to prevent any personal
injury.

4. Lift the analyzer from the pallet & place at installation space. (Refer section Floor
Requirements).

5. Gently slide the Probe upwards, making sure you do not damage the probe, once
you have reached the top most position, rotate it and position it over the trough.

6. Gently slide the Stirrer arm upwards, making sure you do not damage the paddles,
once you have reached the top most position, rotate it and position it over the
trough. Remove the protective material.

7. Gently slide the CRU arm upwards to the top most position, making sure you do
not damage the probes, and remove the protective material and clean debris.

8. Remove the buffers that are present in the RGT & ASP areas, as well around the
CRU Stirrer and Probe.

EM 200
2-8 System Installation

The instrument is shipped, mounted on "Z" brackets; the "Z" bracket and the
four legs may support the entire weight of the instrument.
Open the bolts of the "Z" bracket to prevent any personal injury.
It is important to have leveling done of the place where analyzer is going to be
installed before placing the analyzer.

Contact authorized service personnel for removing analyzer from use for repair
and maintenance.
Follow regional or international norms for disposal of analyzer once end of
life.

2.3.3 Accessories checklist


The analyzer is fully inspected before leaving the factory and carefully packed to withstand shocks in
transit.

On receiving the analyzer, check the package externally; make sure that there is no external visible
damage to the shipping container. If there is damage please make a note of it, if possible photograph
it and inform the designated service personnel. Verify with the invoice, if all the boxes have arrived.

The accessories supplied with the analyzer are subject to change without prior
notice.

The shipment generally contains the following packages:

Analyzer wooden box

Accessories cardboard box (mounted on pallet)

Other accessories boxes (optional) could include

Printer

Computer etc.

EM 200
System Installation 2-9

SR.NO. ITEM DESCRIPTION QTY.


CODE

1 --- INSTALLATION & OPERATION MANUAL 1 NO.

2 --- SOFTWARE CD 1 NO.

3 115252 ASSEMBLY D.I. CAN 20 LTR, ADAPTOR & 1 NO.


STICKER_S

4 115253 ASSEMBLY WASTE CAN 20 LTR, ADAPTOR & 1 NO.


STICKER_S

5 115255 ASSEMBLY BIOHAZARD CAN 10 LTR, ADAPTOR & 1 NO.


STICKER_S

6 115254 ASSEMBLY DETERGENT CAN 10 LTR, ADAPTOR & 1 NO.


STICKER_S.

7 105403 REAGENT TRAY ASSY. 1 NO.

8 104764 REAGENT TRAY COVER ASSY. 1 NO.

9 104664 STANDARD SAMPLE TRAY (1-30) ASSY. 1 NO.

10 107051 RGT BOTTLE LOCATING PLATE – XL200 1 NO.

SHIPPER BOX CONTAINING

11 114769 CABLE USB JUMPER USB2.0 28X1P+ 24X2C - USB A 1 NO.


TO B 2.0 VERSION WITH FERRITE CORE (BOTH SIDE
A,B ) 1.8 METER

12 100343 TYPE E/F PLUG 1 NO.

13 105067 SAMPLE TUBE WITH BAR CODE LABELS. 10 NOS.

14 100634 TEST TUBE ADAPTER FOR MOULDED SAMPLE 35 NOS.


HOLDING PLATE

15$ 108159 ASSY. OF WASTE CAN TUBE & CAN CAP. ( Ensure 1 NO.
that cap is properly engaged on can)

16$ 108162 ASSY OF BIO-HAZARD CAN TUBE & CAN CAP 1 NO.
( Ensure that cap is properly engaged on can)

17$ 108160 ASSY. OF DI. WATER CAN TUBE & CAN CAP 1 NO.
( Ensure that cap is properly engaged on can)

18$ 108161 ASSY OF CLEANING SOLUTION CAN TUBE & CAN 1 NO.
CAP ( Ensure that cap is properly engaged on can)

19 182581 REAGENT BOTTLE (20ML) WITH CAP (White colour) 25 NOS.

20 182584 REAGENT BOTTLE (50ML) WITH CAP (White colour) 24 NOS.

21 --- REAGENT BOTTLES (20 ML.) WITH CAPS AND BAR 2 NOS.
CODE LABELS

22 --- REAGENT BOTTLES (50 ML.) WITH CAPS AND BAR 2 NOS.
CODE LABELS

EM 200
2-10 System Installation

23 100592 5 ML.REAGENT BOTTLE ADAPTER (NEW) 50 NOS.

24 109880 OUTER HOLDER FOR 5ML REAGENT ADAPTOR 10 NOS.

25 SCREW CAP (PP) OF 19mm RED COLOUR FOR 15 NOS


121410
BOTTLES

26 100660 PVC SUPPORT FOR 20ML REAGENT BOTTLE 25 NOS.

27 100536 RUBBER CUP FOR SAMPLE TRAY 10 NOS.

28 105970 RUBBER CAP FOR MOLDED TOP COVER_XL-200 11 NOS.

29 110318 CABLE TIE SIZE 2.5 MM X 100 MM KP138 25 NOS.

30 110317 MOUNT ADHESIVE 10 NOS.

31 110321 FLAT CABLE SUPPORT KP161E 05 NOS

32 109522 KIT FOR SYRINGE BUBBLE REMOVAL 1 NO.

33 102932 SAMPLE CUPS 300 NOS.

34 108605 FUNNEL 1 NO.

35 100679 CALIBRATION PLATE 1 No.

36 201209 GAUGE FOR PROBE CALIBRATION(XL-200/EM 200/


RES-920) 1 No.

37 100263 CUVETTE (4C:0609) 3 Nos.

38 - RGT BARCODE ALIGNMENT JIG. 1 No

39 106653 LEVEL SENSOR ASSY FOR 20LTR DI WATER CAN 1 No

40 106654 LEVEL SENSOR ASSY FOR 10LTR CLEANING SOLN


CAN 1 No

41 106655 LEVEL SENSOR ASSY FOR 10LTR BIOHAZARDOUS


CAN 1 No

42 106656 LEVEL SENSOR ASSY FOR 20LTR WASTE CAN 1 No

P. M. KIT (NEW) II

43 102851 CUVETTE DRIER 2 NOS.

44 105474 LAUNDRY ASPIRATION TUBING SET (2 PROBE 2 SET


CONSTRUCTION )

45 105475 LAUNDRY DISPENSING TUBING SET (2 PROBE 1 SET


CONSTRUCTION)

46 182220 PHOTOMETER LAMP ASSEMBLY 4 NOS.

47 104604 SET OF FUSES 1 SET

48 107613 10 MICRON FILTER (125MM LENGTH) 4 NOS

49 107580 BD SPINAL NEEDLE (25 GA 3.5IN,0.50X90MM, ITEM 1 NO.


405257)

EM 200
System Installation 2-11

50 101677 PROBE CLEANER 1 NO.

51 109712 WASHER FOR CRU KNOB 1 NO.

52 114435 FILTER 25 MICRON (75MM LENGTH) 04 NOS.

53 100675 COUNTER WEIGHT FOR DETERGENT ( SS316L) 01 NOS

54 107623 10-32 SPECIAL TAPERED THREAD WITH 1/4? HEX TO 2 NOS.


200 SERIES BARB 3/32? (2.25MM) ID TUBING,
NATURAL KYNAR PVDF; X220-J1A

55 108103 10-32 SPECIAL TAPERED THREAD WITH 1/4" HEX TO 2 NOS.


200 SERIES BARB 1/16" (1.6MM) ID TUBING,
NATURAL KYNAR PVDF; X210-J1A

56 1/16-27 NPT THREAD WITH 5/16" HEX TO 200 SERIES 2 NOS.


107621 BARB, 1/8"(3 MM) ID TUBING, NATURAL KYNAR
PVDF; 16230-J1A

57 1/16-27 NPT THREAD WITH 5/16" HEX TO 200 SERIES 1 NO.


108084 BARB, 3/32" (2.25 MM) ID TUBING, NATURAL
KYNAR, PDVF-16220-J1A

58 100937 SILICON TUBING R3350 2 MM X 4 MM (INTEGRA) 4 FEET

ACCESSORIES FOR ISE UNIT

59* 113952 Reference Electrode For ISE 1 NO.

60* 113954 Na Electrode For ISE 1 NO

61* 113953 K Electrode For ISE 1 NO

62* 113956 ECl Electrode For ISE, 1 NO

63* 100346 SPACER ELECTRODE REF 5206 1 NO

64* 113957 CLEANING SOLUTION 1 NO

65* 100315 REAGENT PACK 1 NO

66* -- REAGENT PACK LOCATION PAD 1 NO.

67* -- COMPUTER WITH MAINS CORD 1 NO.

68* -- KEYBOARD 1 NO.

69* -- MOUSE 1 NO.

70* -- FLAT SCREEN MONITOR WITH CORD SR. NO. 1 NO.

71 -- FQC REPORT 1 NO.

72 113654 UNIT INSTALLATION INSTRUCTION SHEET 1 NO.

73 -- HYDRAULIC DIAGRAM SHEET. REV. 1 NO.

74* -- ROHS Declaration 1 NO.

75 121368 ERBA (XL) WASH KIT NEW ( 04 X100ml ) 1 NO.

EM 200
2-12 System Installation

* Optional (As per the customer’s requirement)

2.3.4 Installing the components of analyzer


The installation of the components should be performed by the trained service
engineer.

To avoid a shock hazard; ground the Analyzer, Computer, Printer and Monitor
using a 3 pin grounded electric outlet. Do not use an adapter, as it could
cause a loose contact and improper grounding.

Confirm that all cuvettes have been fitted properly into their respective slots on
the reaction tray and none of them are jutting out.

When removing or placing the cuvettes into their slots make sure that you grip
them by their sides and top end, never let the fingers or any sharp objects
coming in contact with the optical area of the cuvettes.

This section gives you the installation of some main components. It includes the following:

Sample Tray and Reagent Tray

Installing DI Water, Cleaning, Bio-hazardous and Waste Cans

Connecting communication cable between Computer and Analyzer

Printer installation

Connecting Test Loader Device to Analyzer PC

2.3.4.1 Sample Tray and the Reagent Tray


1. Unpack the Sample tray from the accessories box and hold the sample tray with your right
hand.

2. Gently place the sample tray into the Sample tray container.

3. Make sure that the index pin on the Sample Transport, slides into the index hole provided on
the sample tray.

EM 200
System Installation 2-13

4. Unpack the Reagent tray from the accessories box and hold the Reagent tray with your right
hand.

5. Gently place the Reagent tray into the reagent tray well.

6. Make sure that the index pin on the Reagent transport slides into the index hole provided on
the Reagent tray.

EM 200
2-14 System Installation

7. Place the respective tray lid over the Reagent Tray and Sample Tray.

2.3.4.2 Installing DI Water, Cleaning, Bio-hazardous and Waste Cans


1. Unpack the Float Sensors for the 4 Cans and place them on one side.

2. From the accessory box remove the 20 liters DI Water Can, 20 liters Waste Can, 10 liters Bio-
hazardous Waste Can and the 10 liters Cleaning solution Can, and put them on the floor.

3. Unpack Float Sensors cables and connect one end to respective connector (located on the
right panel of the analyzer) and connect other end to the respective Cans (Longer float sensors
with blue sleeves for DI Water, green sleeves for Cleaning solution, red sleeves for Bio-
hazardous Waste, and yellow sleeves for Waste).

4. Fill the DI Water Can with 20 liters of fresh DI water and unpack the tubing from the accessory
box. Install filter in DI water Can.

5. Take two separate tubes and connect one end to the Blue ringed outlet marked DI-WATER
and White ringed outlet marked DI-WATER LAMP provided on the analyzer. Connect other
ends to the SS (stainless steel) nozzle and White ringed nozzle on 20 liter DI Water Can.

Make sure that the tube connected to Blue ring on the analyzer should be
connected to SS nozzle on the DI water Can and the tube connected to White
ring should be connected to White ringed nozzle (for lamp cooling).

6. Now, fill 5 liters of DI water into the cleaning solution to prepare working cleaning solution: Add
50 ml of neutral cleaning solution to 5 liter of DI water to prepare a 2% solution.

7. Now take another tube and connect one end to the Green ringed outlet marked CLEANING
and other end to green ringed nozzle on 10 liter Cleaning solution Can.

8. Take two separate tubes and connect one end to the Red ringed outlet marked WASTE-3 and
BIO-HZ. Connect other ends to the red ringed nozzle on 10 liter Bio-hazardous Can.

9. Take one more tube and connect one end to the Yellow ringed outlet marked WASTE-2 and
connect its other end to the yellow ringed nozzle on 20 liter Waste Can.

10.Now connect the large diameter silicon tube to the analyzer outlet marked TROUGH WASTE
and connect the other end of the tubing into the 20 liter Waste Can.

EM 200
System Installation 2-15

Take care that all the above-mentioned tubes reach their respective containers
without any sharp bends or obstructions.

The waste consists of a natural drain. Make sure that the large silicon waste
tube from the analyzer to the Waste can is slant and in downwards direction
without any bends.
Failing to take the above precaution may cause a back flow of waste solution,
out of the manifold air release tube on waste manifold. Or could result in noisy
operation, big gargling sounds being created by the waste lines.

2.3.4.3 Connecting communication cable between Computer and Analyzer


Follow these instruction to connect the analyzer from the computer:

1. Unpack the USB cable from the accessories box, and connect its one end to the USB port of

EM 200
2-16 System Installation

the computer and other end to the USB connector located on the left side of the instrument,
as shown in figure below.

2. Connect one end of the power cord to the analyzer’s power outlet and other end to the main
power supply as shown in figure above.

Make sure that the On/Off power button should be in OFF condition before
turning on the main power supply.

The instrument is connected with the computer and ready to power on.

2.3.4.4 Printer Installation (DeskJet / Laser)


Check for following points before using application software to generate printouts:

1. Install appropriate printer driver on the analyzer PC.

2. Connect the printer to the analyzer PC.

3. Feed the paper to the printer and switch it ‘ON’.

4. There should be no paper jam or any other obstruction in the printer.

5. Print a test page from the analyzer computer to confirm correct printing.

2.3.4.5 Test Loader Device Connecting to USB on analyzer PC


Follow the steps below to connect Test Loader device to USB port on analyzer PC.

1. Unpack the Test Loader device,Test Loader stand and USB cable from the accessories as shown

EM 200
System Installation 2-17

in below figure

2. Place USB -B (Right angle) end of USB cable inside the Test Loader stand as shown in below
figure.

3. Fix the Test Loader device on this connector as shown in figure.

4. Now connect the USB-A connector to USB port on analyzer PC

EM 200
2-18 System Installation

5. Once connected to analyzer PC, it gives the beep sound that means now Test Loader is ready to
use.

6. Now Keep the System Reagent pack in front of scan side of Test Loaderr device as shown in
below figure.

7. Go to Status Monitor > Scan Pack > System Pack details > Scan Pack, scanned details will be
displayed on analyzer PC.

8. If Test Loader device is unconnected following message will get displayed..

EM 200
System Installation 2-19

EM 200
Part

III
Software Installation 3-2

3 Software Installation

This section guides you through the installation and un-installation procedure of MultiXL software.
You must read the instructions carefully before installing the software.
See the following sections in more details:

Pre-requisites

Software installation procedure

Read the necessary general safety guidelines before installing the softw are for the first
time. See Safety Instructions for more details.

3.1 Safety Instructions


The software installation and re-storing database should be done by the trained
person only.

3.2 Pre-requisites
Make sure that you should have the following pre-requisites before installing the software.

See the following section in more details:

System configuration

PC Settings Required for Windows XP

Regional and Language Settings for Windows XP

PC Settings Required for Windows 7

Regional and Language Settings for Windows 7

PC Settings required for Windows 10

Regional and Language settings for Windows 10

Test Loader Device

3.2.1 System Configuration

Before installing the MultiXL software, make sure that your computer should have following
minimum system configuration.

PROCESSOR Intel Core-2-duo Processor or higher

OPERATING Windows 7 Professional 32 bit EN


SYSTEM
Windows 10 Professional 32 / 64 bit EN

EM 200
3-3 Software Installation

TBM OS of Windows-10 IoT

HARD DISK 500GB (minimum) or higher

RAM 4GB (minimum)

MONITOR 17 inch / 19 inch color monitor with 1024 * 768 resolution

PRINTER LaserJet / DeskJet Printer

3.2.2 PC Settings required for Windows XP

Remove all memory resident software including anti-virus software from the Analyzer PC.

Remove firewall, automatic update, other security software and / or settings from the Analyzer
PC.

Do not run any other application on the Analyzer PC during batch run on Analyzer.

Disable Screen-savers and Power Management on Analyzer PC before starting the Application
Software.

Ensure that a default printer (Laser Jet / Desk Jet) is configured and connected to Analyzer
PC. Set appropriate printer should be set as default printer.

Delete the “Microsoft Office Document Image Writer” and “Microsoft XPS Document Writer”
from the system. See the following procedure.

Go to Start > Settings > Control Panel > Printers and Faxes. Select the “Microsoft Office
Document Image Writer” and delete.
Similarly, delete “Microsoft XPS Document Writer”.

Windows Login User requires Administrative privileges to Install and Run the Application.

3.2.3 Regional and Language Settings for Windows XP


Ensure that the following regional and language settings are appropriate.

Note that these are critical settings for the communication with the Analyzer.

Go to Settings > Control Panel > Regional and Language Options.

Use the following steps for setting the regional and language options:

1. Select Regional Options tab, and define the following settings. See figure below:

EM 200
Software Installation 3-4

2. Select Languages tab, and define the following settings. See figure below:

3. Select the Advanced tab, and define the following settings.

EM 200
3-5 Software Installation

3.2.4 PC Settings required for Windows 7

In case, *customized image of Windows 7 Embedded is installed as Operating


System, required PC Settings will be applied automatically.
* A customized image of Windows 7 Embedded is provided by the analyzer
manufacturer, as Operating System for Analyzer PC.

However, the following PC settings are necessary, before installing MultiXL.

Remove all memory resident software including anti-virus software from the Analyzer PC if
installed. Use the following procedure:

Click Start button, and click Control Panel. Now, under the Category view, go to
Programs > Programs and Features. Select the desired anti-virus software from the
list, and click Uninstall.

Remove firewall, automatic update, other security software and from the Analyzer PC.

Click Start button, and click Control Panel. Now, under the Category view, go to
System and Security > Windows Firewall, and click on the link Turn off Windows
Firewall on or off. Now select the option Turn off Windows Firewall (not recommended),
and then click OK button.

To turn off automatic updates, under Control Panel, go to System and Security >
Windows Update, click on the link Change settings, and select the Never check for
updates (not recommended) from the drop down list, and click OK.

Do not run any other application on the Analyzer PC during batch run on Analyzer.

Ensure that a default printer (Laser Jet / Desk Jet) is configured and connected to Analyzer
PC. Set appropriate printer as default printer.

Delete the “Microsoft Office Document Image Writer” and “Microsoft XPS Document
Writer” from the system.

EM 200
Software Installation 3-6

Click Start button, and click Control Panel. Now, under the Category view, go to
Hardware and Sound > Devices and Printers. Right click on the Microsoft Office
Document Image Writer, and choose Remove Device to delete. Similarly, delete
“Microsoft XPS Document Writer”.

Windows Login User requires Administrative privileges to Install and Run the Application.

Disable Screen-savers and Power Management on Analyzer PC before starting the


Application Software.

Use the following procedure for disabling the screen saver and power management:

1. Open Screen Saver Settings by clicking the Start button, clicking Control Panel, clicking
Appearance and Personalization under Category view, clicking Personalization, and
then clicking Screen Saver.

2. To turn off all screen savers, under Screen Saver, select (None) from the drop-down list,
and then click OK.

3. Now click on the link Change power settings (Applicable only if option is available). The
following screen will be displayed.

EM 200
3-7 Software Installation

4. Click on Balanced Change plan settings.

Set Turn off the display to Never

Set Put the computer to sleep to Never

5. Click on the link Change advanced power settings. The following screen will be
displayed. Set Turn off hard disk after to Never.

EM 200
Software Installation 3-8

6. Similarly, apply same settings to Power saver option. Repeat the step 3 to 6.

User account control settings

Follow these steps to change the user account settings:

1. Open User Account Control Settings by clicking the Start button, and then clicking
Control Panel. Under Small or Large icons view, click on User Accounts and then,
again click User Accounts. The following window will be displayed.

2. Now click Change User Account Control settings. The following screen will be
displayed.

EM 200
3-9 Software Installation

3. Move Pointer to Never Notify and click OK.

4. You must re-start the analyzer PC to turn on the user account control.

3.2.5 Regional and Language Settings for Windows 7


Use the following procedure for setting the regional and language options:

Ensure that the following regional and language settings are appropriate.

Note that these are critical settings for the communication with the analyzer.

Go to Settings > Control Panel > Clock, Regional and Language Options > Change the date,
time and number format.

EM 200
Software Installation 3-10

a. Following should be the settings for Formats tab:

b. To set Number and Currency, Click on Additional settings.

EM 200
3-11 Software Installation

c. Following should be the Location tab:

d. Following should be the Language tab.

EM 200
Software Installation 3-12

e. Click on Change Keyboards following screen will display:

f. Following should be the settings for Administrative tab:

EM 200
3-13 Software Installation

3.2.6 PC Settings required for Windows 10


In case, *customized image of Windows 10 IoT is installed as Operating System,
required PC Settings will be applied automatically.
*A customized image of Windows 10 Embedded is provided by the analyzer
manufacturer, as Operating System for Analyzer PC.

The following PC settings are required before installing MultiXL.

Remove all memory resident software including anti-virus software from the Analyzer PC if
installed. Use the following procedure:

Click Start button, and click Control Panel. Now, under the Category view, go to
Programs > Programs and Features. Select the desired anti-virus software from the list,
and click Uninstall.

Remove firewall, automatic update, other security software and from the Analyzer PC.

Click Start button, and click Control Panel. Now, under the Category view, go to System
and Security > Windows Firewall, and click on the link Turn off Windows Firewall on
or off. Now select the option Turn off Windows Firewall (not recommended), and then click
OK button.

To turn off automatic updates, under Control Panel, go to System and Security >
Windows Update, click on the link Change settings, and select the Never check for
updates (not recommended) from the drop down list, and click OK.

Do not run any other application on the Analyzer PC during batch run on Analyzer.

Ensure that a default printer (Laser Jet / Desk Jet) is configured and connected to Analyzer
PC. Set appropriate printer as default printer.

Delete the “Microsoft Office Document Image Writer” and “Microsoft XPS Document
Writer” from the system.

EM 200
Software Installation 3-14

Click Start button, and click Control Panel. Now, under the Category view, go to
Hardware and Sound > Devices and Printers. Right click on the Microsoft Office
Document Image Writer, and choose Remove Device to delete. Similarly, delete
“Microsoft XPS Document Writer”.

Windows Login User requires Administrative privileges to Install and Run the Application.

Disable Screen-savers and Power Management on Analyzer PC before starting the Application
Software.

Use the following procedure for disabling the screen saver and power management:

1. Open Screen Saver Settings by clicking on Control Panel > Appearance and
Personalization under Category view, click Personalization, and then click Screen
Saver.

2. To turn off all screen savers, under Screen Saver, select (None) from the drop-down list, and
then click OK.

3. Now click on the link Change Power Settings / Power Options (Applicable only if option is
available). The following screen will be displayed

4. Click on Balanced radio-button and then the corresponding Change plan settings button as
shown above.

Set Turn off the display to Never

Set Put the computer to sleep to Never

EM 200
3-15 Software Installation

5. Click on the link Change advanced power settings. The following screen will be displayed.
Set Turn off hard disk after to Never as shown below;

6. Similarly, apply same settings to Power saver option. Repeat the step 3 to 6.

User Account Control Settings

Follow these steps to change the user account settings:

EM 200
Software Installation 3-16

1. Select Control Panel. Now, under the Category view, go to System and Security >
Security and Maintenance . Move Pointer to Never Notify and click OK. The
following screen will be displayed.

2. Now, click on Change User Account Control Settings option as shown above. The
following screen appears;

EM 200
3-17 Software Installation

3. Move Pointer to Never Notify and click OK

4. You must re-start the analyzer PC to turn on the user account control

3.2.7 Regional and Language settings for Windows 10


Use the following procedure for setting the regional and language options:

Ensure that the following regional and language settings are appropriate.

Note that these are critical settings for the communication with the analyzer.

Go to Control Panel > Clock, Language, and Region options > Change the date, time and
number format.

EM 200
Software Installation 3-18

a. Following should be the settings for Formats tab:

b. To set Number and Currency, Click on Additional settings

EM 200
3-19 Software Installation

c. Following should be the Location tab

EM 200
Software Installation 3-20

d. Following should be the settings for Administrative tab:

EM 200
3-21 Software Installation

3.2.8 Test Loader Device


Test Loader Device is used to scan the details of system packs for Closed channel reagents.

Test Loader Device is required for Test Loader System.

Test Loader Functionality

Test Loader device scans the details of System Pack Reagent kits including lot number,
expiry date, pack size etc.

Analyzer performs open/closed-channel tests only after scanning the System Pack Reagent
kits / special cards.

Analyzer performs closed channel tests based on pack size (test count) of respective
reagent kit.

Analyzer performs open channel tests not exceeding the total test-count, as read from
System Pack Reagent kits. Open channel tests can also be loaded using special cards
which may be available for purchase from manufacture in special circumstances.

System will intimate user about expiry of open test counts (for cards expiring soon) as read
from the special cards / System Pack Reagent kits.

Once open test-counts are exhausted, it is not allowed to perform further open tests, until
user scans the new System Pack Reagent kits or special cards..

System will intimate user during run if open test count reaches 10 & below.

3.3 Software Installation Procedure


This section guides you through MultiXL software installation process.

Follow the instructions in this section in case you are installing the application software for the first
time on the computer i.e. there is no previous installation of the software on that computer. See the
following sections in more details:

Installing MultiXL

Installation of Database

Installing Team Viewer

Upgrading MultiXL Software (to upgrade MultiXL from existing version to the new version)

Database Utility Options

Accessing MultiXL Software

EM 200
Software Installation 3-22

3.3.1 Installing MultiXL


Follow these instruction for installing the application:

1. Insert the installation CD into the CD drive of your computer. On inserting the CD, the MultiXL
Installation screen will be displayed.

OR

Go to Windows Explorer, right-click on CD/DVD ROM-Drive, and click on AutoPlay option.

OR

Go to Windows Explorer. Right-click on CD/DVD ROM-Drive. Click on Explore and


double-click on Launcher.bat.

2. Click on Install MultiXL Application & Database link and follow the on-screen instructions.

OR

EM 200
3-23 Software Installation

Click on the Browse this CD link. The software installation CD contains the following folders
and files as shown in the figure below:

3. Open Setup folder, and double-click on the setup.exe.

On clicking, the following screen will be displayed.

This screen will not be displayed if .NET framework is already installed


on your computer.

4. Click Accept to continue. On clicking, the following screen will be displayed.

EM 200
Software Installation 3-24

This screen will not be displayed if Crystal Reports is already installed on


your computer.

5. Click Accept to continue. On clicking, the following screen will be displayed.

This screen will not be displayed if SQL Server 2005 Express Edition is
already installed on the analyzer computer.

In case, Microsoft SQL Server Desktop Engine (MSDE) is already installed then the
following screen will be displayed in Windows XP. The installer will not proceed with the
MultiXL installation.

EM 200
3-25 Software Installation

Click on Close and uninstall the Microsoft SQL Server Desktop Engine from Control
Panel > Add / Remove Program. Then start the MultiXL installation again.

Please refer to Migration Guide for Database Engine, MSDE to SQL Server Express
2005 from the Installation CD, namely “Migration Steps from MSDE to SQL
Express.chm”.

In case of Windows 7 operating system, following screen may appear while installing
MultiXL Application. Please click on Run Program button to continue with MultiXL
Installation.

.
It is not necessary to apply SQL Server 2005 Service Pack 3 (SP3) or later
Service Pack as shown in the above screen shot.

On clicking, the following screens will be displayed in a sequence.

EM 200
Software Installation 3-26

Wait until the setup wizard is visible on the screen as shown below.

6. Click Next. On clicking, the following window will be displayed.

EM 200
3-27 Software Installation

On keeping Configure Database check-box checked (ticked), the installer will create or
upgrade the database along with the installation of MultiXL.
(In case, the Database is found present then the existing database will be upgraded to the
latest version. When the Database is not found then the installer will create a blank
Database).

In case, Configure Database option is unchecked; the installer will not create/upgrade the
database and you have to install it manually. Refer section Installing Blank Database for
more details.

7. Click Next. The following screen will be displayed.

The installer will install the software in the default location C:\Program Files\MultiXL.

EM 200
Software Installation 3-28

The installation in a location, different from the default one, is not


recommendable.

8. Ensure that “Everyone” is selected, and click Next. On clicking, the following window will be
displayed. Click Next to confirm the installation.

9. On clicking Next, the installation is started and the status will be displayed, as shown below.

The following screen will be displayed if the Configure Database option is selected.

EM 200
3-29 Software Installation

Once the above operation is completed, the software icon will be created on the desktop and
the Installation Complete screen will be displayed.

10. Click on Close to close the screen and restart the computer.

Now double click on the MultiXL icon from the desktop or choose Start > All
Programs > MultiXL to start the application.

The Detect Regional Settings screen will be displayed and the


application halts in case, if the language setting in the Formats tab is
other than English (United States).
.

EM 200
Software Installation 3-30

See section Region and Language Settings for Windows XP for more details.
For Windows 7 operating system, see section Regional and Language Settings for Windows
7.

The following observations are noted after installing MultiXL on Windows 7 Embedded operating
system:

MultiXL Shutdown: On clicking Shutdown button in MultiXL, analyzer PC will shutdown


automatically, after completing auto-maintenance activities on analyzer.

The windows key (left and right) will be disabled from the keyboard. Logging of MultiXL
start and shutdown events (for internal use).

MultiXL screen will cover the desktop in its maximized state.

USB mass storage devices will be disabled.

USB drive can be accessible through Administrator login only.


To copy software data to USB drive, use Utility > Backup screen. See section
Copy Data to External USB Storage for more information.

Full MultiXL database backup and log files are automatically archived in the C
drive under MultiXLLog folder, after every seven days before system shutting
down.

Restricted user account for MultiXL: To install and uninstall any application from the PC, you
must be logged on as (windows) user “Administrator”. To log in to the administrative account,
go to Start > Shutdown > Logoff and then click the Administrator icon and provide the
administrator password.

Along with MultiXL installation, Consumable Management Utility will get


installed on analyzer PC which can be used to load value files and default test
parameters.

3.3.2 Installating Database


The installation and restoring database should be performed by the trained
person only.

EM 200
3-31 Software Installation

Database installation is required only if the Configure Database option is de-selected (unchecked)
during installation (Refer step 10 of section Installing MultiXL).

In case, Configure Database option is selected (ticked by default) during Software Installation then
the Database will be created / upgraded automatically as part of installation. (Database, when
already exists, will be upgraded to the latest version. When database is not found on PC, then the
installer will create a blank database).

In case, the Configure Database option is not selected, then the database should be installed
manually, as follows.

Always use Database Utility folder from the software CD, which consists of files
required to install or upgrade the database.

See section Installing Blank Database for more details.

In case user is getting “Operating System error 5 (Access denied)” while


performing the above mention steps then refer section 10.2.1 SQL Server 2005
Configuration for SQL Server 2005 Settings.

3.3.2.1 Installing Blank Database


For installing the blank database from software CD, use the following instructions:

1. Click on Run Database Utility from the MultiXL installation screen as shown below.

OR

Open the Database Utility folder from the software installation CD, and double-click

EM 200
Software Installation 3-32

DatabaseUtility.exe.

Default Database folder is the one from where the DatabaseUtility.exe is running. Database
folder refers to the Database, required for performing various operations and storing the result
data.

2. Click on CHECK DATABASE. This command will check for the existing database on your
computer. If no database is available, a message is displayed on the following screen.

3. Click on CREATE DATABASE.

This will create the database from the location specified on the screen. This is the default
location where the blank database is stored in software installation CD. (To restore the
backup of new database, you need to change the location using BROWSE FILE button.
Refer section Restoring Backup of New Database in section Change Database more
details).

For example, in the above screen, the database location is E:\Database Utility\MultiXL BKP.

If Archive is not available, then utility will ask for Blank Database location and the following
window will be displayed. Now select the blank database file MultiXL.BKP from the software
CD, and then click Open.

EM 200
3-33 Software Installation

5. After some time, the database will be created successfully and the following screen will be
displayed.

6. Once the database is created, click CHECK DATABASE to ensure the proper creation of the
database. The following screen will be displayed.

The above screen indicates that the database is created successfully. Click Close to exit from
the utility screen. Now you can access the MultiXL application. (Refer section Accessing MultiXL
Software for more details).

EM 200
Software Installation 3-34

Make sure that all software versions are installed correctly.

To check the installed software versions, go to Service Check screen, right click
on the Misc Commands button, and choose Software Version option.

3.3.3 Installing Team Viewer

Team Viewer is used to access analyzer computers, which makes it an ideal solution for Remote
Monitoring and Trouble Shooting purposes.

Pre-requisite for Analyzer PC and Remote PC:

a) Internet connection availability - uninterrupted with good speed.

b) Team-viewer is not blocked in System Settings for PC/Network Security.

Team Viewer connectivity depends upon the Internet speed available at the
Lab/Site and load on analyzer PC. Team Viewer uses remote desktop
technology to control a computer from an alternate location. The main cause of
lag when controlling a remote computer is network speed.

Regular PC cleanup and maintenance should be carried out to keep your PC


running at optimum speed. Disk Cleanup application scans and deletes
unnecessary files and Disk Defragmenter improves performance by eliminating
the gaps in data. Use the Start menu's search box to locate these programs.
Viruses also impact performance. Update your virus definitions and complete a
full system scan.

It is not recommendable to use Team Viewer remote control session during


Batch RUN with Actual Patient samples on the analyzer, as it may slow-down /
interrupt the system performance.

Installation Procedure:

1. On insertion of CD on Auto-play, MultiXL Installation screen will be displayed with the option to
install Team Viewer.

EM 200
3-35 Software Installation

OR

1. Go to Windows Explorer and Right Click on CD/DVD ROM-Drive and Click on Auto-play.

2. Click on Install Team Viewer. On selection of this option, following pop-up appears;

3. Team Viewer installation is carried out at default installation location C:\Program Files\
TeamViewer.

4. After Team Viewer is installed successfully, above screen will be closed automatically and user
will be redirected to the Launcher Screen.

Start-up procedure for Team Viewer remote support

EM 200
Software Installation 3-36

Open Team Viewer 10 Host from Windows Start menu. Following screen appears;

Team Viewer ID (Your ID marked in Red in above image) is unique for every device. This ID of the
Analyzer PC is required for connecting another Remote PC through TeamViewer. Password is
“tbm1234@”, by default.

Password is pre-configured by default, during installation of TeamViewer


Host.

Analyzer user / operator has to share Your ID (Team Viewer ID marked in RED) to the support
team for Remote Support (Remote control session on Analyzer PC).

Do not change the default password for the seamless remote support.

3.3.4 Upgrading MultiXL Software


If MultiXL software is already installed on your computer and if you receive a newer version of
software, then the following steps should be performed.

Upgrade Software

Upgrade Database

Take a database backup through Utility > Backup, before proceeding with
software upgrade.

EM 200
3-37 Software Installation

3.3.4.1 Upgrade Software

You can upgrade the software version by un-installing the existing software version from the PC and
installing the newer version from the CD as follows.

Un-installing Software

To un-install the software, do one of the following:

1. Click on the Uninstall MultiXL Application from the MultiXL Installation screen as shown
below.

OR
Go to Start > Settings > Control Panel. In the Control Panel, double click on Add or
Remove Programs. This method is used only, if you are using Windows XP operating
system.

For Windows 7/10 operating systems, click Start button on the desktop, under Category
view, go to Control Panel > Programs > Programs and Features.

2. Select the MultiXL, and then click Uninstall. On clicking, the software will be removed
from the computer.

EM 200
Software Installation 3-38

To uninstall the MultiXL software you must be logged on as user


“Administrator”.

Installing Software - New version

Refer section Installing MultiXL for more details.

3.3.4.2 Upgrade Database


Upgrade the database using the software CD of the newer version whenever you install the new
software version.

Database can be upgraded to match the newer software version without deleting the database of the
existing version.

Ensure to take database backup before upgrading the database.

Upgrading Database

Database is upgraded using upgrade script file. The upgrade script is


provided in the application software CD in the Database Utility folder.

Follow these instructions for upgrading the database:

1. Click on the Run Database Utility link from MultiXL Installation screen as shown below.

EM 200
3-39 Software Installation

OR

1. Open the Database Utility folder from the software installation CD. Double-click on
DatabaseUtility.exe.

2. Click UPGRADE DB.

A window will appears to select the upgrade script file, see the following screen.

Select the upgrade script file from the software CD, and then click Open.

This will start the upgrade process. If archive database is not available then the utility will
prompt to select the path for blank database and the following screen will be displayed.

EM 200
Software Installation 3-40

The upgrade script file is provided in the application software CD in


the Database Utility folder.

4. Click OK and select the blank database file MultiXL.BKP from the software CD, and then
click Open.

5. After some time, the database will be upgraded successfully and the following screen will
be displayed.

Click to close the database utility screen.. After successful database up-gradation,

EM 200
3-41 Software Installation

you can access the MultiXL application. Refer section Accessing MultiXL Software for
more details.

After installing the new software version, if the database is not upgraded
using the upgrade script file provided in the Software CD then the following
screen will be displayed on starting the application software. This screen
indicates the software and database version mismatch.

In case, the Software and Database version mismatch screen is displayed; upgrade the
database using the script file, provided in the software CD. Refer section Upgrading
Database for more detail.

If the problem is not resolved, then call service engineer for help.

Make sure that all software versions are upgraded correctly.

To check the installed software versions, go to Service Check screen, right


click on the Misc Commands button, and choose Software Version option.

3.3.5 Database Utility Options


The Database Utility can be used to take the Database Backup or change the Database.
See the following section for more details:

Database backup

Change database

Restore archive database

3.3.5.1 Database Backup


Follow these instructions for taking the backup of database:

1. Click on Run Database Utility from the MultiXL Installation screen.

OR

1. Open Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE. The following screen will be displayed.

EM 200
Software Installation 3-42

3. Press BACKUP DATABASE key. The following screen will be displayed.

4. Select the path to store the backup file, and then click Save. On successful completion of
database backup, following screen is displayed.

If archive database is present then backup will be stored with “ARH” extension with the same
default file name.

For example: In this case archive backup will be stored on the same path with file name
“MultiXL2522011.ARH”. The default file name contains “MultiXL” (the application name),
followed by date, month and year.

EM 200
3-43 Software Installation

3.3.5.2 Change Database


In case, if you wish to change the database, you must delete the existing database and then restore
the backup of another database using database utility,

It is recommended to change the database with proper guidance of expert


service engineer. Improper installation may impact the calibration of the
analyzer, in addition to loss of data such as QC data and chemistry calibration.

Before installation, you should take the backup of the database before deleting
or changing the database.

Database can be changed in two parts:

Delete (existing) Database

Restore Backup of another Database

Deleting Existing Database

Follow these instructions for deleting the database:

1. Click on the Run Database Utility from the MultiXL Installation screen.

OR

1. Open the Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE to check whether the database is present.

3. Click on DELETE DATABASE to delete the existing database. The following screen will be
displayed.

EM 200
Software Installation 3-44

4. Click on Yes to continue with database deletion. On clicking, the warning message will be
displayed to re-confirm the deletion.

5. Click Yes to continue. On clicking, a message will be displayed to take the database
backup before deletion.

6. Click Yes to take the backup. The following window will be displayed. Select the
appropriate location for saving the backup database.

On clicking No, Production (Live) & Archive database will be deleted without
taking the database backup.

Best Practice: Backup database before deleting the same.

7. Click Save to save the database.

EM 200
3-45 Software Installation

On clicking, a copy of database will be saved in the desired location. The following screen
will be displayed after successful deletion of the database.

Restoring Backup of New Database

Follow these instructions for deleting the database:

1. Click on Run Database Utility from the MultiXL Installation screen.

Or

1. Open Database Utility folder from the software installation CD. Double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE.

3. In the DATABASE RESTORE UTILITY window, click on the BROWSE FILE. Select the
location where the backup database file is saved.

4. Select the appropriate database file and then click Open. The following screen will be
displayed.

EM 200
Software Installation 3-46

5. Click on CREATE DATABASE to create the database. The database create the database
following screen will be displayed.

If the Archive is not available then utility will ask for blank database location.

6. Click OK and select the blank database file MultiXL.BKP from the application CD.

7. Click Open. After successful creation of database, following screen is displayed.

EM 200
3-47 Software Installation

8. Click on CHECK DATABASE to ensure proper creation of the database.

9. Click to close the database utility screen.

Now you can access the MultiXL application. (Refer section Accessing MultiXL Software for more
details)

3.3.5.3 Restore Archive Database


Restoring Archive Database

Follow these instructions to restore the archived database:

1. Click on the Run Database Utility from the MultiXL Installation screen.

Or

2. Open the Database Utility folder from the software installation CD. Double-click
DatabaseUtility.exe.

3. Click on RESTORE ARCHIVE.

4. The following window will be displayed. Select the appropriate location where the archive
database is saved and then click Open.

5. After restoring the archive database successfully, the following screen will be displayed.

EM 200
Software Installation 3-48

3.3.5.4 Taking Diagnosis Backup


This button is used to take the database backup for diagnosis which will be without patient
demographics to support patient privacy policy.

Diagnosis backup can be used by support team only for troubleshooting purpose.

Following are the list of demographics that are excluded from the diagnosis database: Patient Name,
Patient ID, Patient Address (line 1, 2 and 3), Patient Tel. No. Patient Remarks, Area i.e. Location of
the Sample Collection, Reference Doctor Analyst.

To take the backup of the data base, use the following steps:

1. Run Database Utility.

2. Click on DIAGNOSIS BACKUP.

3. On clicking, the diagnosis backup database will be created with a file name and saved in the
location C:\MultiXLLog folder. See figure below.

4. For example, diagnosis backup created on 30 Sept 2013 at 11:30:45 am will have file name
“MultiXL_20130930113045.DIAG”.

5. After the completion of backup, user should copy the file name and send to support team for
diagnosis.

3.3.6 Accessing MultiXL Software


MultiXL screens are best viewed with 1024 * 768 resolution.
On starting the application, the PC resolution will be automatically changed to
1024*768 pixels, only if the resolution is different than specified. On closing
MultiXL, the previous resolution will be restored.
On successful installation, the MultiXL software application will be launched automatically at every

EM 200
3-49 Software Installation

PC startup.

When the MultiXL application is running, all windows shortcut keys (e.g. left and right window keys,
etc) available on the keyboard is not accessible.

To access the software do one of the following:

Turn on the analyzer PC. MultiXL application will start automatically OR

Double click on the MultiXL icon created on your desktop OR

Go to Start > All Programs > MultiXL

When starting MultiXL first time, the product login screen as shown below will be displayed.

Product Login is critical (one-time) stage. Software is configured suitably based


on the inputs in this screen. Please contact Service Engineer, in case Product
Login details are not available on Software CD.

Enter the appropriate details in the PRODUCT LOGIN, PASSWORD and LOCATION. Then, click
OK. On clicking, the login screen as shown below will be displayed.

This screen will be displayed every time, on starting MultiXL.

Enter the following details, and then click OK. You may use this Login details for the first time and
create the other login IDs with appropriate user access rights. See section User Rights for more
details.

Login ID : Guest or guest

Password : Guest (Case – sensitive)

The main screen will be opened as shown in the following screen.

EM 200
Software Installation 3-50

When you start the MultiXL application first time without connecting the
analyzer, the application title bar will displays “CS” after MultiXL version
number on top which indicates Closed System.
MultiXL version number with "TLS" indicates Test Loader System.

Whether the system installed is Closed System or Open System or Test Loader
System will be automatically detected when analyzer is connected and
switched ON.

Error System is reported if combination of embedded software version is not


proper or any hardware issue.

EM 200
Part

IV
Saftey Information 4-2

4 Saftey Information
Before operating the analyzer, it is necessary that you read and understand the safety instructions,
safety precautions and warning labels listed below.

Safety Symbols

Warning Labels

Safety Precautions

Read all safety notices carefully and make sure you understand them.

4.1 Safety Symbols


Before you attempt to use the analyzer, you must be fully familiar with the following symbols and
their meanings:

Symbols Meanings

DO NOT TOUCH

BIOLOGICAL HAZARD

SERIOUS ELECTRIC SHOCK

DANGER, WARNING, CAUTION

DANGER OF BURNS

BIOLOGICAL RISKS

BATCH CODE AND SERIAL NUMBER

4.2 Warning Labels


The following warning labels are affixed on the analyzer on different places that are the potentially
hazardous.

EM 200
4-3 Saftey Information

Labels Places

On the 4 piece top cover plates

On the 4 piece top cover plates

On the 4 piece top cover plates

On the Bio-hazard Waste Can (10 Liters)

On Waste Can (20 liter)

On Cleaning Solution Can (10 liter)

On DI Water Can (20 liter)

4.3 Saftey Precautions


Read the necessary safety instructions carefully, before using the analyzer for the first time.

Only qualified and trained personnel should use the analyzer and perform the procedures

EM 200
Saftey Information 4-4

described in this document.

General safety:

Danger of injury to hands by moving parts. During operation, do not touch auto
sampler unit, reagent unit, arm probe and any other moving mechanical parts in
the analyzer. During operation, shut cover all the time.

Pay attention not to exceed the time and volume necessary for diagnosis.

Keep monitoring the behavior of the whole system in order to detect any
malfunction.

Take immediate corrective measures including shutdown of operation when any


malfunction is detected in the analyzer.

Avoid possibilities of any direct access by the patients.

Turn off the power after every operation so that control is restored to its previous
state as directed.

Do not remove the line cord plugs from receptacles by pulling the cords so that
no undue stress is developed in the cords.

Wipe the probe tips of SRPT several times with cloth or by rubbing alcohol
before the analyzer is used. At this time, do not forget to put medical rubber
glove. Pay attention to prevent bare skins of hands or arms from being touched
by or pricked with the probe tip.

Pay attention to the storage area.

Keep the analyzer out of the rain and any other water splash.

Avoid areas that are adversely affected by atmospheric pressure,


temperature, humidity, ventilation, sunlight, dust and air containing salt,
sulfur, etc.

Pay attention to inclination, vibration, shock (including shock during


transportation), etc.

Avoid areas adjacent to the storage room of chemicals or areas that are
likely to generate gasses. Avoid areas that are likely to be subject to
inclination, vibration and shock.

Organize and store parts and cords associated with the analyzer after they
have been cleaned.

Keep the analyzer clean not to cause any inconvenience to the next use.

In the event of trouble in analyzer, do not troubleshoot by your own. You must
contact the authorized service personnel.

Prohibit any alteration and/or modification to the analyzer without permission by


manufacturer.

EM 200
4-5 Saftey Information

Electrical safety:

The access to the conductive parts within the analyzer may cause serious
electric shock. When removing parts, make sure to shut off the main power
supply from the socket. Leave any maintenance and repair of electrical parts
inside the equipment to qualified service personnel.

Always replace the halogen lamp with the new lamp only after been kept off for
30 minutes, to avoid the danger of burns. Keep hands away from the glass part
of the new halogen lamp. Make sure that there is no crack or breakage in the
glass part.

Biological safety:

Never touch patients' samples, SRPT probe, reaction cuvettes, and stirrer
paddles with bare hands to prevent operator from possible infection. Wear
disposable medical rubber gloves to keep skin from direct contact with patients'
samples.

Treat the drain water as infectious waste. Collect the drain water in reserve can
and allow it to be disposed of by expert distributors.

Wipe the probe tip of SRPT several times with cloth or by rubbing alcohol before
the analyzer is used. At this time, do not forget to put medical rubber gloves.
Pay attention to prevent bare skins of hands or arms from being touched by or
pricked with the probe tip.

Treat the drain water as infectious waste. Collect the drain water in reserve can
and allow it to be disposed of by expert distributors.

Sample handling:

Do not touch the samples, mixtures and waste liquids with bare hands. Give
special consideration to keep skin and mucous membrane from contact with
reagents to prevent operator from possible infection. Always wear disposable
medical rubber gloves, goggles, etc. to keep skin and mucous membrane from
contact with reagents.

Always follow the laboratory's safety protocol for cleaning and decontaminating
the Sample & Reagent tray, Bio-hazard and Waste can.

In case any samples come in contact with your skin, thoroughly rinse the area
that came in contact with the sample and consult a physician.

Immediately wipe off any contaminants from the system.

Reagent handling:

Danger of cauterization and skin poisoning through contact with reagents.

After unpacking the reagents, be sure not to allow dust, dirt or bacteria to come
in touch with the reagent.

EM 200
Saftey Information 4-6

Always keep reagents in cool place.

Do not use reagents that are expired.

Handle a reagent gently to avoid formation of bubbles.

Take care not to spill the reagent. If it spills, wipe it off immediately using a wet
cloth.

Always take the reagents by the approved vendor.

If a reagent comes in contact with your eye, wash it off immediately using
plenty of water, and take medical treatment at once.

If you swallow it inadvertently, call for a doctor immediately and drink plenty of
water.

Some reagents are strong acids or alkalis. Exercise great care so that your
hands and clothing do not come into contact with reagents. If your hands or
clothing come into contact with either reagent, immediately wash them off with
soap and water. If a reagent comes into contact with your eye(s), immediately
rinse with water for at least 15 minutes..

Maintenance and checks:

Incorrect cleaning and maintenance can cause damage to personnel and


equipment. Perform cleaning and maintenance according to the procedures
described in this publication.

It is important for the analyzer and its associated parts to be periodically


checked.

Arm probe

Cuvette rinsing unit (laundry)

Stirrers

Syringes

Refer section Replacement schedule for spares and consumable for more
details.

Ensure that the analyzer operates normally and correctly, when it is reused
after being unused for some time.

Perform Daily, Weekly, Monthly and Annually maintenance procedures as


directed in the operator manual. Refer section Maintenance for more details.

In the event of trouble in analyzer, do not troubleshoot by your own. You must
contact the authorized service personnel.

Prohibit any alteration and/or modification to the analyzer without permission by


manufacturer.

EM 200
Part

V
Technical Specification 5-2

5 Technical Specification
This section tell you the technical specification of the system in detail.

See the following sections:

General specification

Sampling unit

Reagent unit

Reaction unit

Optical absorption measurement unit

Control unit

Data processing

Ion selective electrodes (ISE)

Installation Condition

Computer Specification

The specifications are subject to change without prior notice.

5.1 General specification

Item Description

Throughput 200 tests per hour for a cycle time of 18 seconds (400 tests per hour with
ISE).

System type Discrete, open, automated, random access, patient prioritized, 1/2
Reagent system.

Sample Serum, Urine, CSF, Plasma, Whole Blood, Others.

Measurement principle Turbidimetric Immunoassay, Colorimetry (Rate/End Point), Ion Selective


Electrodes (optional).

Applicable analytes Photometric assays: Enzyme, lipid, protein, sugar, nitrides, inorganic
substances, complements and others.
Turbidimetric assays: IgG, IgA, IgM, C3, C4, RF, CRP, ASO, Transferrin
and others.
ISE Potentiometric Assays: Na, K, Cl, Li

Test method Absolute measurement, Relative measurement, ISE (optional).

EM 200
5-3 Technical Specification

On board Reagent 50 test items maximum, 54 test items with ISE.


Positions

Programmable Any number of photometric tests


parameters Any number of calculation items

Assay modes 1-Point, 2-Point, Rate-A, and Rate-B.

Sample volume 2-70 µl (adjustable in 0.1 µl step).

Reaction volume 180 µl to 550 µl.

Reaction temperature 37 °C.


Temperature stability: ± 0.2 °C.

Reaction time Depends on the designated cycle time and number of reagents used For
1 step assay (using R1)
648 seconds (10 minutes 48 seconds) for a cycle time of 18
seconds
For 2 step assay (using R1 and R2)
1st reaction 306 seconds (5 minutes 6 seconds) + 2nd reaction
324 seconds (5 minutes 24 seconds) for a cycle time of 18
seconds

Test selection Setting of tests one by one or with profile key for each sample.
Group order entry is possible.
Setting from host computer via interface (optional).

Maintenance Programmable maintenance actions: Cuvette Rinse, Water Save,


Auto Wash, Probe Wash, Prime Wash, ISE maintenance and Calibration

Barcode identification Sample barcode formats - NW7, Code 39, Code 128, ITF, 2 of 5 standard,
UPC A.
Reagent barcode ID (ITF).
During batch run, barcode scan for reagent is performed.

Water supply unit Water consumption: Less than or equal to 7.5 liters/hour.
Manufactures and supplies: Type 2 quality (by NCCLS standards) ion
exchange water (optional).

System Warm-up Time 5 minutes system warm-up time.

Safety mechanism Vertical obstruction detection, Capacitance based liquid level sensing.

Noise level Less than 65 dB with cover closed.

5.2 Sampling unit

Item Description

EM 200
Technical Specification 5-4

Sample container Blood collection tube 10 ml (16 x 100 mm), 7 ml (14.5 x 84 mm), 5 ml
(13 x 75 mm).
Adaptors will be provided for 5 and 7 ml tubes.
2 ml Sample Cup, 500 µl Standard Cup

Sample placement Sample tray


Outer Most Track: 15 positions for placing barcode tubes.
Middle Track: 15 positions for placing barcode tubes.
Innermost Track: 9 positions for placing Sample cup and
Standard cup without barcode.

STAT samples Place anywhere on the Sample Tray.


STAT samples are measured preferentially.
Interrupt permitted even during analysis.

Sampling Pipetting system with plunger, driven by stepper motor.


Sample volume: 2-70 µl (adjustable in 0.1 µl step).

Pipetting mode Discharges set volume of sample into cuvette or the ISE module
(optional).

Sampling probe Micro-pipette with level sensor.


Washing solution.
Outside: Preheated DI water.
Inside: Preheated DI water.
Equipped with vertical obstruction detection facility to prevent probe
crash.

Sample dilution Dilution ratio: 2 to 150 times.


A cuvette is used as dilution vessel.
Set amount of diluent and sample is dispensed into a cuvette by probe.
Dilution possible for repeat run.
Direct reduced/increased volume runs are also possible.

Repeat run Execution by repeat run list or auto execution.


Auto execution according to abnormal marking and/or range over.
Reduced/increased volume repeat run also possible.

Sample identification Sample bar-code format - NW7, Code 39, Code 128 (A,B,C), ITF, 2 of 5
standard, UPC A and 3-18 digits (depending on the length of the
barcode)
Position ID for non barcoded samples

Dead Volume

EM 200
5-5 Technical Specification

5.3 Reagent unit

Item Description

Type Turn table type reagent tray.

Reagent tray Common reagent tray for reagent 1 and reagent 2.

Reagent cooling 8 ± 4 °C cooled with refrigeration unit.


temperature

Reagent bottles 25 positions for placing 50 ml bottles


25 positions for placing 20 ml bottles

Reagent dispensing Pipetting system with plunger, driven by stepping motor.


R1 dispensing in the 1st cycle
R2 dispensing in the 17th cycle

Reagent volume Reagent 1: 50 – 300 µl (adjustable in 1 µl step).


Reagent 2: 0 or 10 – 200 µl (adjustable in 1 µl step).

Dead volume

Reagent identification Sample bar-code format - ITF.


Reagent bar-code ID (18 digit barcode readability).

Residual volume Calculated by countdown system as well as measured by capacitance


information type level sensor and displayed on screen.

Reagent positions Total 50 positions for accommodating reagent 1 and reagent 2.

Reagent protection Reagent cover to protect from evaporation, dust, and direct light.

Carry over actions Provision for extra Reagent Wash, Detergent Wash, System Wash and
Cuvette Skipping given for Carry-Over Pairs.

5.4 Reaction unit

Item Description

Type Turn table.

Reaction tray Rotating tray.


Number of reaction cuvettes: 45.
Temperature control: Turn table direct heating by foil heaters.

Reaction temperature 37 ± 0.2 °C

Cuvettes Reusable.
Number of reaction cuvettes: 45.
Dimensions: 5 x 4.9 mm.
Optical path length: 5 mm (factor to be fed for 10 mm).

EM 200
Technical Specification 5-6

Material: Hard glass made of Quartz.


Volume: 700 µl.
Reaction liquid volume: 550 µl maximum, 180 µl minimum.

Reaction liquid mixing Type: Immersion mixing by rotating mixers.


Singe mixer (3 variable mixing speeds).
Mixing steps.

The 1st step: Right after Reagent 1 and sample dispensing into
the respective cuvette

The 2nd step: After Reagent 2 dispensing in the cuvette


containing Reagent 1 + sample

Cuvette washing Type: By the automatic washing system.


The reaction waste is aspirated out, then cuvette is washed by washing
solution and repeatedly by DI water, finally residual liquid is removed.
Number of washing operation steps: 7 steps.
Reaction waste removal: 1 step
Washing: 5 steps
Residual liquid removal: 2 steps
Number of washing solution application.
Detergent solution: 1
Ion exchange water: 5
Washing solution container.
Detergent: 10 liters Capacity
Reaction waste is collected into two waste cans (concentrated waste and
diluted waste) by pumps.
In built cuvette overflow protection.

5.5 Optical absorption measurement unit

Item Description

Type Multiple Wavelengths, Static Filter.

Photometric system Multi-wavelength direct measurement of light after penetration into


reaction cuvette (transmitted light).

Wavelength 8 Wavelengths: 340 nm, 405 nm, 505 nm, 546 nm, 578 nm, 600nm, 660
nm and 700 nm.

Wavelength per One or two wavelength.


chemistry

Measurement interval Total 36 points.


Every 18 seconds for 18 second cycle time.

OD range OD 0 – 3.
Light path calculated as 10 mm.

Resolution 0.0001 OD

EM 200
5-7 Technical Specification

Light source Pre-aligned Halogen lamp (12V/20W).

Detector Silicon photo-diodes.

Cell blank correction Corrected by water blank measured after cuvette washing.

Minimum reaction 180 µl.


liquid volume

5.6 Control unit

Item Description

User interface Operating System:


hardware Windows 7 Professional 32 bit EN
Windows 10 Professional 32 / 64 bit EN
TBM OS of Windows-10 IoT
CPU: Intel Core-2-duo Processor or higher
RAM: 4GB (minimum)
Hard disk: 500GB (minimum) or higher
Monitor: Color Monitor with 1024*768 resolution support, 17” & above
In built CD/DVD Writer
Printer: LaserJet / DeskJet Printer

System interface USB Port: [Minimum 6 ports, preferred 8 ports]


Network Ethernet
PCIe 1x slot
Serial Port:2 RS232 Ports
Mouse (USB preferred)
Keyboard (USB preferred)
In-built Speaker.

5.7 Data processing

Item Description

Calibration curve K-Factor, Linear (one point, multipoint, and point-to-point), Cubic Spline,
Exponential, 4P Calibration Logit-log, 5P Calibration Logit-log,
Polynomial.
Multipoint curves up to 10 points.
One point correction (using Blank) to multi-point calibration line is
provided.
Auto-dilution for nonlinear curves.

Quality control Within day as well as day-to-day X and X-R control diagram.
Mean, SD, %CV, R are calculated for the each chemistry.
QC graph based on west gard QC rules

Repeat run Execution by repeat run list or auto execution.


Auto execution according to abnormal marking or range over.
Increased/decreased volume repeat run also possible.

EM 200
Technical Specification 5-8

Monitor function Reaction curve, Calibration curve, Status of sample operation and
Reagent level in bottles can be viewed graphically.

Calculation between Correlation correction factor (Y = aX + b).


items Calculation by the formula defined by user.
No Limit for Programming Calculation Items.
Each calculation item can include up to 5 chemistries.
Recalculation of results possible.
Test profile can be defined.

Report/list format Report generation: Patient wise, Test wise, Date wise, Location wise,
Abnormal result wise, Doctor name wise, Batch wise.
Lists: Abnormal values list, Pending run list, Repeat run list.

Backup Partial backup of selective data such as Consumables, Patient, Patient


with Results, Test Parameters, Calibration, Error Log, System parameters
Is possible in the Text, XML, XLS and CSV formats.
Full Backup.

Special treatment Reagent blank correction.

Data check Reference range check by age, gender, sample type.


Panic limit check.
Reagent absorption check.
Technical limits check.
Reaction linearity check.
Reaction mixture absorbance checks.
Antigen excess/prozone check (by reaction curve analysis method).

Alarms and notices Types of alarms: Erroneous operation, mechanical malfunction of


analyzer, data processor hardware error, erroneous test results and dome
opening.
Alarm level: Notice, temporary halt of analysis, suspension of analysis,
system stop.
Prompts on display alarms.

Diagnostic checks Mechanical movements and functional performance can be checked


through diagnostic menu.

Password Different user ID with password to login into the application.


Access Control for Menu options can be defined by Administrator.

5.8 Ion selective electrodes (ISE)

Item Description

Type of Ion selective electrode.


measurement Direct measurement for Serum samples.
Urine sample diluted with urine diluent (on board, on Reagent Tray).

Sample types Serum, Urine (urine diluted 10 times on board for first determination).

EM 200
5-9 Technical Specification

Test items Na, K, Cl, Li

Measurement cycle Serum: 30 seconds/sample.


Urine: 40 seconds/sample.

5.9 Installation Condition

Item Description

Power source/ AC 220 V ± 10%, 50 ± 1 Hz or AC 110 V ± 10%, 60 ± 1 Hz.


consumption Power consumption: 600 VA (excluding PC/Printer/Monitor).

Fuses 5A for 220V and 10A for 110V input supplies

Drainage Used sample (concentrated waste solution) and washed sample (diluted
waste) are to be drained separately.

Ambient temperature 15 – 30 °C.


Variation during operation: Less than ± 2 °C per hour.

Relative humidity 40 – 80% free from water dew formation.

Dimensions 810 mm (W) * 700 mm (D) * 600mm (H).

Weight Approximately 120 kg.

5.10 Computer Specification

Item Description

User interface Operating System:


hardware Windows 7 Professional 32 bit EN
Windows 10 Professional 32 / 64 bit EN
TBM OS of Windows-10 IoT
CPU: Intel Core-2-duo Processor or higher
RAM: 4GB (minimum)
Hard disk: 500GB (minimum) or higher
Monitor: Color Monitor with 1024*768 resolution support, 17” & above
In built: CD/DVD Writer
Printer: LaserJet / DeskJet Printer

System interface USB Port: [Minimum 6 ports, preferred 8 ports]


Network Ethernet
PCIe 1x slot
Serial Port:2 RS232 Ports
Mouse (USB preferred)
Keyboard (USB preferred)
In-built Speaker.

EM 200
Part

VI
6-2 User Interface

6 User Interface
You can control the day-to-day operation of the instrument through the MultiX L s oftware. This section
describes the main features of the user interface and how to move between the various screens.

See the following sections for more details:

A first look at the user interface

Main menu layout

Screens

6.1 A first look at the user interface


When you have logged on, the Patient Entry screen is displayed.

1 Main menu
Click on any menu item to display the corresponding screens.

2 Navigation button
Click to navigate first, previous, next and last records.

EM 200
User Interface 6-3

3 Command buttons
Click to print, save, clear, edit and delete.

4 Text box
To enter the data for that field.

5 Drop-down list
Allows the to choose one value from a list.

6 Dotted button
Click to select and enter data for that field.

7 Check box
When selected, that a particular feature has been enabled.

8 Indication box
Provides help or warning messages.

9 Tests
Click to select the test.

1 Radio button
To choose only one of a predefined set of options.

2 Crossed button
To clear the text for that field.

3 Calender button
To select the date.

EM 200
6-4 User Interface

6.2 Main menu layout


Main menu consists of various screen items through which you can perform a set of generally related
tasks. You can open a work screen by:

Clicking one of the w ork screen items Or

Pressing the appropriate function key (see below )

Main menu Function What can it do


screen items key

F2 This s c reen is us ed for defining s ample det ails , pat ient


demographic s and s c heduling t es t s / c alc ulat ion it ems or
profiles .

F3 This s c reen is us ed for defining t es t det ails , t es t volumes &


referenc e ranges .

F4 This s c reen is us ed for defining new profiles or c alc ulat ion


it ems .

F5 This s c reen is us ed for viewing t he QC Dat a and t win plot


graph. It is als o us ed for viewing t he c alibrat ion c urve for a
part ic ular t es t and for s c heduling blank s / s t andards /
c alibrat ors / c ont rols .

F6 This s c reen is us ed for definit ion of reagent s , s t andards ,


blank s , c ont rols , diluent s and was h s olut ion.

F7 This s c reen is us ed for performing c alibrat ion, pat ient run,


viewing reagent level in bot t les of different t es t s and
performing s ample and reagent barc ode s c ans . It is als o us ed
t o view online reac t ion c urve and IS E pac k det ails .

F8 This s c reen is us ed for s earc hing pat ient res ult s , c alibrat ion/
c ont rol res ult s , pat ient s , c ons umables or t es t det ails .

F9 This s c reen is us ed for viewing pat ient report s , c alc ulat ing
s t at is t ic al dat a us ing Tes t S t at is t ic s s c reen, viewing res ult s
on Res ult Reprint s c reen, V iew t he c alibrat ion of a t es t over a
period of t ime on Calibrat ion Trac e, V iew t he c urrent
c alibrat ion on Calibrat ion Monit or, Log of all t he errors on
E rror Log s c reen, reac t ion c urve of t he res ult s obt ained on
Reac t ion Curve s c reen and Reagent c ons umpt ion on Ot her
s c reen.

-- This s c reen is us ed for defining mis c ellaneous paramet ers


lik e A rea, Laborat ory , Doc t or’s Det ails , A naly s t Det ails et c .

F11 This s c reen is us ed for defining Reagent P os it ions , B ac k up


Dat a, t o view Offline Res ult s and rec alc ulat e t he res ult s
obt ained.

-- This s c reen is us ed only by S ervic e P ers onnel.

EM 200
User Interface 6-5

F12 This s c reen is us ed for performing Maint enanc e operat ions at


t he s t art and end of t he day .

-- This s c reen is us ed for defining s y s t em paramet ers , c arry over


pairs , t es t s equenc e, rerun flags , hos t s et t ings and t o as s ign
us er right s .

-- This opt ion is us ed t o manually hibernat e t he analy z er t o s ave


power. This power-s aving mode requires s upport ing hardware
on t he analy z er. Henc e, t he opt ion will be vis ible only if t he
analy z er is having t he
required hardware. On c lic k ing Hibernat e, t his opt ion will t urn
as W ak e-up t o ac t ivat e t he analy z er from t he power-s aving
mode.

-- This opt ion is us ed t o arc hive Mult iXL dat a or view t he


A rc hived dat a. This opt ion will be vis ible only when t he dat a
ex c eeds t he defined t hres hold limit s or already t he arc hived
dat a available.

-- This s c reen is us ed t o t urn off t he applic at ion s oft ware.

6.3 Screens
This section describes the following main menu screen items in more detail:

Patient Entry

Test Parameters

Profiles/Calc

QC/Calibration

Consumables

Status Monitor

Search

Reports

Master

Utility

Service Check

Maintenance

Settings

Archive

Shutdown

EM 200
6-6 User Interface

6.3.1 Patient Entry

Patient Entry is used to enter the patient details like name, address, doctor referring patient, analyst,
age, gender etc can be entered using this screen. Also, the routine tests, calculation items, profiles
to be performed on the patient sample can be requested using this screen. These patient
demographics are used to generate the patient report after analysis of the sample.

This screen is divided into two sections:

One for defining information related to Sample definition and other for Patient demographics entry.

Commands buttons available for clearing the patient schedule, checking work list, mask tests and
copy tests.

Single patient can have more than one Sample ID.

See the following links for more details:

Sample Definition Parameters

Patient Definition Parameters

Clear Schedule

Work List

Copy Tests

Mask Tests

Download Samples from LIS

CEC

EM 200
User Interface 6-7

6.3.1.1 Sample Definition Parameters

Parameters Description
Sample ID This field is used for assigning an alphanumeric identification number of up to
18 characters to each patient. Entry in this field is compulsory and cannot be
skipped. If the Sample ID is already entered, then the user can view the
Sample ID by clicking on the dotted button placed next to the Sample ID text
box.
Position In case the sample is not bar-coded, the user should specify the sample
position in this text box. An assigned sample position cannot be used for
some other sample. Any sample Positions on the sample tray can be entered.
If there are more than maximum no of Sample Positions, then a different Group
No. needs to be selected.
For bar-coded samples the sample position is automatically assigned as per
the group number selected after the sample bar-code scan.
For emergency samples, any position that is vacant can be used for any group
during Patient Run.
Group This field is used to assign group numbers for various samples processed
during the day. If there are more than maximum sample positions, then the
user needs to select Group 2 and so on. The user can assign the Group
Numbers from 1 to 99.
Emergency Whether the given sample is an emergency sample or not is specified using
this tick option. To designate a sample as an emergency sample, tick in this
field and assign one of the free positions for the sample. Emergency samples
are given priority over routine samples in a run.
Barcoded The user can select whether to use sample bar-code facility or not. If the bar-
code option is set to ON in the Settings > System Parameters screen, then
the sample position fed by the user is ignored. The user has to select/deselect
the check-box for whether the sample for the particular patient is bar-coded or
not. The barcoded option can be selected to only the outer two rings of sample
positions.
During Run, changing status from non barcoded to barcoded is ignored (not
saved) for a Sample ID in progress.
Sample Type Select the sample type from the drop down list. The default options available
are: Serum, Urine, CSF, Plasma, Whole Blood and Other
Sample Select the sample volume type using the drop down list. The available options
Volume Type are Normal, Increase and Decrease. The default value is Normal. User may
select Increase or Decrease, in case the sample concentration is roughly
known. If the sample has low concentration then the user can select an
increase volume. If the sample is high concentration sample, then the user can
select decrease volume.
Container Select the sample container type from the pull down option. There are various
Type options available and one can select the container type by selecting the drop
down list. Default container type can be set from Settings > System
Parameters screen.
Samples This option enables you to enter the sample replicates for a specific patient
Replicates sample. When user entered the sample replicate value through Patient Entry,
then all the tests ordered for that particular sample, including rerun, will be
performed in the specified number of replicates. In this case, sample replicate
value defined in Test Parameter > Test Details will not be considered by the
system while processing the sample.

When sample replicates value is 1 (or left blank), then each test will be
performed as per sample replicates entered in Test Parameter > Test Details

EM 200
6-8 User Interface

screen.

Sample replicate value should be entered between 2 to 30. By default, this


parameter is programmed as 1.

Sample replicates will not be downloaded from LIS with


patient demographics as ASTM protocol does not facilitate it.

Registration This field is used to enter the date at which the patient was registered in the
Date hospital.
Collection
This field is used to enter the date at which the sample was drawn.
Date
Sample Remarks about sample can be fed here using up to 50 alphanumeric
Remarks characters. Previously fed remarks can be selected by pull-down options. The
remark is printed in the patient report.
Area This is used to select the area / location from where the sample is collected.
One can select the area list by clicking on the dotted button. On clicking the
dotted button, area help screen is displayed. From the list displayed on
screen, user can select the desired area by double clicking on the particular
name. This area will be printed in Patient Report as Location. User may define
area / location from Master -> Area screen. Area details can be entered using
Area screen.

Ref Doctor

This is used to select the name of the referral doctor. Alternatively, if the admin
needs to enter the doctors’ details, then he/she can enter from master screen.
One can select the doctor’s list by clicking on the dotted button. On clicking
the dotted button, following screen is displayed. From the list displayed on
screen, user can select the doctor’s name by double clicking on the particular
name for the respective patient. Doctor details can be entered using Doctor
screen.

EM 200
User Interface 6-9

Analyst This is used to enter the name of the analyst. Alternatively, if the admin needs
to enter the analysts’ details, then he/she can enter from master screen. One
can select the analyst’s list by clicking on the dotted button. On clicking the
dotted button, following screen is displayed. From the list displayed on screen,
user can select the analyst’s name by double clicking on the particular name
for the respective patient. Analyst details can be entered using Analyst screen.

6.3.1.2 Clear Schedule


This screen is used to clear the patient samples scheduled on the sample tray. Use Clear
Schedule button provided on the Patient Entry screen.

EM 200
6-10 User Interface

You only need to define the sample positions in From Position and To Position text box. Valid
positions are from 1-30 and I-1 to I-9.

Clear Schedule and Position

The option will deletes the test requests scheduled for analysis and the positions for the Sample
IDs on selected positions on clicking OK button. The samples and patients are not deleted.

Delete Sample

The option will delete the samples on the selected positions along with demographics and the test
requests scheduled. Option to recalculate test results is not available for deleted patient samples.

6.3.1.3 Work List

The Work List button available on the Patient Entry screen displays the list of requested test for
a particular group number. On clicking the following screen will be displayed.

EM 200
User Interface 6-11

The work list for any group can be viewed by selecting the following options All, Patients,
Calibrations or Controls.

On selecting ‘Patients’ option, only patient samples are displayed in the work list. On selecting
‘Calibration’, work list will display Blank, Standards and Calibrators programmed.

On selecting ‘Controls’, work list will display controls programmed in the respective group.

The test from the Work List screen can be masked using Mask Test(s) option.

The work list includes the following details:

Parameter Name Description

Group No. It displays the Group number that has been selected.

Sample Position It displays the Sample position assigned. For bar-coded samples, the
position is assigned after the sample barcode scan.

Sample ID It displays the Sample Id assigned to the patient.

Sample Type It indicates whether the Sample type is Serum/ Urine/ CSF/ Whole
Blood/ Other type.

Sample Vol Type It indicates whether the sample volume is Normal/ Increase/ Decrease.

Test It displays the test name.

Replicates It displays the number of repetitions that a test will undergo during run.

Sample Volume It indicates the Sample volume programmed in test parameters for that
particular test.

R1 Volume It indicates the R1 volume programmed in test parameters for that


particular test.

R2 Volume It indicates the R2 volume programmed in test parameters for that


particular test.

R1 Position It displays the position of R1 for that particular test as defined in Utility-
Rgt. Position.

R2 Position It displays the position of R2 for that particular test as defined in Utility-
Rgt. Position.

The Work List includes the details of barcoded samples too even though their positions may not
be known.
Tick the Mask Tests option to mask one or more tests from the entire group.

6.3.1.4 Copy Tests


Use this option to copy the same tests and calculated items across patient samples.

Enter the patient and sample details and schedule the tests/calculated items. Then click on the
Copy Test(s) button. Upon clicking this button, enter From and To sample positions, to which you
desire to copy test schedule. The entire range of sample positions would be assigned the same tests
and calculation items.

When the option Generate Sample ID is checked, an incremental sequential series of unique Sample

EM 200
6-12 User Interface

IDs will be generated for the range of selected positions.

During run, when Copy Test(s) option is used:

Masked Test of source Sample ID will be copied as Masked Test(s).

Scheduled, Completed and In Process Test(s) of source Sample ID will be copied as


Scheduled Test.

Pending Test of source Sample ID will be copied as Scheduled Test, if required parameters
such as sample/reagent details are available. Otherwise, it will be copied as Masked Test.

While copying ISE tests from Serum Sample to Urine sample, Lithium test will be excluded; as
Lithium is not performed for Urine Samples.

Following screen illustrates an example to copy test(s) of source Sample ID (selected in Patient
Entry screen) to Sample positions 2 to 6 of Group 1, along with generation of Sample ID (unique
sequential series).

6.3.1.5 Mask Tests

Upon scheduling the tests, the user can click on the Mask Tests button to mask the tests
temporarily which should not be run immediately, but can be run in the middle of the run. The
selected tests for the selected Sample ID will be masked.

To mask the Test(s) for the (multiple) Samples. Tick the Mask Tests check box in the Patient
Entry > Work List screen and select the required test(s). This feature is useful if the reagent for
the tests are not available but would be made available during the middle of the run. In these
cases, the user can mask the tests and keep them on hold.

Once the reagents are available, then the user can unmask the selected tests from Status
Monitor > Work List screen.

EM 200
User Interface 6-13

To mask the Test(s) for the entire multiple samples, select the option Mask Test(s) in the Patient
Entry > Work List screen.

6.3.1.6 Download Samples from LIS

This button is displayed on the Patient Entry screen only when the Host
Connection check-box is selected in Settings > System Parameters screen.

The Download Sample button is used to download the sample details (like patient name, age,
gender, sample type, etc) along with the test details; from the LIS for the selected samples;
irrespective of whether they are barcoded or non-barcoded samples, that are placed on analyzer’s
Sample Tray.

The test details will be automatically downloaded by clicking Sample Barcode


Scan button through Status Monitor > BARCODE SCAN or during batch before the
run starts, if option Sample Barcode Scan is selected from PRE-RUN options.

Before downloading the sample details from the LIS, make sure that you should have the following
necessary pre-requisites:

The option Host Connection in Settings > System Parameters screen should be selected.
The Host Setting screen is always enabled to view the settings.

Follow the procedure to download non-barcoded samples from the LIS:

1. Place the barcoded or non barcoded sample on the analyzer’s sample tray.

2. Go to Patient Entry screen, and define required details for the added samples.

3. Click on Download Sample button.

It will display a window containing all registered sample IDs with check-box option to select.

EM 200
6-14 User Interface

4. Now, select the required sample IDs details to be downloaded from the LIS and click
Download.

On clicking, the sample details will be downloaded from the LIS to barcoded samples and the details
are displayed in the Patient Entry screen.

If the communication between Host and LIS is not established then it should pop
up message to check connection in Host Settings screen.

6.3.1.6.1 Patient Definition Parameters

Parameters Description
Patient Name Enter patient name in the field using the keyboard. A maximum of 30
characters can be fed in this field. Alternatively, patient can be selected
using the dotted button placed next to the Patient Name. Also, if the user
desires to use the same patient with different sample ID, then he/she can
double click on the dotted button and select the patient name for a
different Sample ID. Hence one Patient can have multiple Sample IDs.
Patient ID Enter patient identity number. For example, social security number or
insurance number can be entered here for printing on Patient Reports.
Category This field is used to identify the sex of the patient. Select as Male /
Female / Child / Other. The default option is Default.

For a patient selecting the category is optional. But if


the category is not selected then the default reference
ranges will be applied. After the run is performed
patient category can be updated and on recalculation of
the results, reference ranges will be applied and hence
the H / L flags will be attached.
Age Enter the numerical age of the patient (in three digits maximum). Choose
age in Days/Months/Years using the pull down option. The patient age is
used to issue H and L flag for the corresponding age range as mentioned
in the Test Parameters (see section Reference Range). If age of a patient

EM 200
User Interface 6-15

is not fed, default normal values are used to issue H and L flags.

Address 50 alphanumeric characters are allowed to enter the address of the


patient.
Patient Tel No This text-box is used to enter the contact number of the patient.
Patient Remarks Remarks about patient can be fed here using up to 50 alphanumeric
characters. Previously fed remarks can be selected by pull-down options.
These remarks are printed in the Patient Reports. .
Height This field is used to enter the height of the patient (in meters).

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

Weight This field is used to enter the weight of the patient (in kilograms).

Body Mass Index (BMI) for the patient is calculated automatically that is
used for Creatinine Clearance calculation. BMI is calculated by the
following formula:

BMI = (Weight)/(Height)2

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

Urine vol(ml/24 hrs) Use this field to define the volume of urine collected from a patient in 24-
hour duration. This is an optional parameter and is used in the calculation
item of Creatinine Clearance. This field can be ignored if user does not
want to use Creatinine Clearance calculation item.
If user wants to use Creatinine Clearance calculation item, entry in this
field is necessary and the user should feed the urine volume (in ml)
collected in 24 hours in this field.

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

6.3.1.7 CEC
This section tell you how to schedule, clear schedule and edit CEC for a patient.

CEC option is available in the calculation item list. When you click on this, following screen is
displayed.

EM 200
6-16 User Interface

When Patient Name is selected then sample Id’s will be displayed in the list for that patient only, and
if the patient name is not selected, then the entire list of sample Id’s will be displayed in the list
irrespective of the patient name. (Patient Name selection is optional). Patient ID is automatically
displayed on selecting the patient name.

Options available on the screen are:

Schedule CEC

Clear Schedule CEC

Edit

For CEC (default calculation item), user can choose any of the photometric test
whose name start with CRE. (e,g. CRE, CREA, CREAT, CRENZ)

6.3.1.7.1 Schedule CEC

This section tell you how to schedule CEC for a patient.

Follow this procedure to schedule CEC:

1. Select Schedule CEC option.

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Select the Sample ID – Urine from the list of sample id with sample type as urine for the
patient selected or all sample id’s.

5. Enter the Height in meters.

6. Enter the Weight in kg.

EM 200
User Interface 6-17

7. Enter the Urine Volume (ml/24 hrs).

8. Click on SAVE button.

On clicking, the Height, Weight and Urine Volume will be updated for both the Sample ID
and the message will be displayed indicating that CEC is schedule successfully.

In case, user changes CEC (Test) definintion after scheduling CEC for the patient
sample, then CEC result will Not be Applicable for existing CEC schedules. A
pop-up appears as shown below;

6.3.1.7.2 Clear Schedule CEC

This section tell you how to clear CEC schedule for a patient.

Follow this procedure to clear schedule:

1. Select Clear Schedule CEC option.

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Sample ID – Urine will automatically be displayed according to the Serum / Plasma Sample
Id selection.

5. Height will be displayed according to the Patient Name / Sample Id selection.

6. Weight will be displayed according to the Patient Name / Sample Id selection.

7. Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection.

8. Click on Delete button.

Message will be displayed indicating that CEC schedule is cleared successfully.

6.3.1.7.3 Edit

This section tell you how to edit CEC for a patient.

Follow this procedure to clear schedule:

EM 200
6-18 User Interface

1. Select Edit option.

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Sample ID – Urine will automatically be displayed according to the Serum / Plasma Sample
Id selection.

5. Height will be displayed according to the Patient Name / Sample Id selection. The height
displayed can be changed.

6. Weight will be displayed according to the Patient Name / Sample Id selection. The weight
displayed can be changed.

7. Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection. The Urine Volume displayed can be changed.

8. Click on SAVE button.

Message will be displayed indicating that CEC schedule is cleared successfully.

6.3.2 Test Parameters


Test Parameter is used to define the analytical parameters and reference range of the tests. The
efficiency of the test depends on a proper choice of the test parameters.

Test Parameter consists of three screens.

EM 200
User Interface 6-19

Test Details

Reference Range

Test Volumes

6.3.2.1 Test Details


This screen will display the list of available default tests with their default parameters. For a particular
test, parameters which are highlighted in gray color textboxes are not editable. To make all
parameters editable, you first need to copy a test with different test name and then make changes.

Using this screen, you can perform the following operations.

Defining new or modify the existing test parameters

Setting auto rerun for multiple test

Copy Test

Down load and upload parameters for a test

Initialize tests from existing ones to default settings

When you see some of the parameters in the Test Parameters screen disabled,
please switch on the analyzer.

Test parameters are not editable during the batch run.

EM 200
6-20 User Interface

Key default tests parameters are not editable except user defined tests.

Every default tests will displays a revision number on top right of the screen for
identification. Using this, user can match the revision number with the one
printed on the kit insert provided in reagent pack to ensure correct parameters
are used with the pack of measurement.

Revision number is displayed on Test Details, Test Volumes, and Reference


Ranges screen for default parameters.

In the closed system, user is allowed to define or add only permitted number of
open channel tests (user defined), after that system will prompt a message.

EM 200
User Interface 6-21

6.3.2.1.1 Test Definition Parameters

This table describes the description of each parameters:

Parameters Description
Test It displays the name of test when clicked on any of the default test from the
Tests grid. For a user defined test, enter a short name for the Test, maximum
up to 5 characters. This test name is used to select / display test(s) on all
screens. A unique name is required for each test as this is the identity. Enter
the name along with appropriate parameters and click on SAVE. Newly
created test name will appear at the end of the Test panel in the bottom of
the screen.
Report Name Enter the full name (50 characters maximum) of the test (assay) that will
appear in the patient report. For example, one feeds Aspartate Transaminase
in this text box, while AST is entered in Test text box.
Host Name Enter test name, up to 5 characters, assigned in the LIS. This name could be
same or different to the Test Name. This text box will be available only if the
Host Connection is activated from Settings > System Parameters screen.

Use this button to view and modify the host name of any Tests in list, if
required. On clicking, the following screen will be displayed.

Select the required test and click EDIT button. Click SAVE after making
changes in host name.
Total Reagents Select the total number of reagents used for the test. The drop-down list
gives selection of 1 or 2 reagents for single and dual assays respectively.

The default value for this parameter is 1.


Reagent R1,
Reagent R2 Upon selecting the Total number of Reagents, the Reagent Name needs to
be selected. This is different from Test Name. Reagent Name is defined in
Consumables > Reagents screen. Select the name of the Reagent to be
used for the test. This is the name that appears in the Utility > Reagent
Position screen while viewing / defining the positions of the Reagents placed
on Reagent Tray.

EM 200
6-22 User Interface

More than one test can share the same Reagent Name.

Assay Type
Use this pull-down option to select the assay type among 1POINT, 2POINT,
RATE-A and RATE-B. It is recommended to use:

1 POINT for end point chemistries

2 POINT for end point chemistries using sample or reagent blank

RATE–A for kinetic/rate assay

RATE–B for kinetic/rate assay with differential slope

1 POINT:

The method is used for normal end-point assays using one or two reagents
where the final absorbance is used for concentration calculation. Mean of the
absorbance’s recorded between M2Start and M2End points are taken and
this is used for the calculation of the sample results.

2 POINT:

This method is used for end-point analysis when a sample or reagent blank is
necessary. In this assay type, the initial absorbance (usually measured after
addition of the first reagent) is recorded and subtracted from the final
absorbance (which is usually measured after addition of the second reagent).
Necessary correction factors to correct the difference in mixture volume are
taken into account while subtracting the initial absorbance. The initial
absorbance recorded is the mean of the absorbance’s recorded between
M1Start and M1End and this absorbance is subtracted from the final
absorbance, which is the mean of the absorbance’s recorded between
M2Start and M2End. This differential absorbance is then used for calculation
of sample concentration.

EM 200
User Interface 6-23

RATE-A:

This method is used for kinetic/rate assays where the change in absorbance
per minute is used for result calculation. The slope (absorbance change per
minute) is obtained from the absorbance’s recorded between M2Start and
M2End using the least square linear regression method as per the following
formula:

.
Where, Ti is the time in minute and Ai is the absorbance, n is the number of
points.

RATE-B:

This method is used for kinetic/rate assays where differential rate is useful.
The initial rate of change in absorbance per minute (usually obtained after
addition of the first reagent) is subtracted from the final rate of change of
absorbance per minute (usually obtained after addition of the second
reagent). Necessary correction factors to correct the difference in mixture

EM 200
6-24 User Interface

volume are taken into account while subtracting the initial rate of change in
absorbance per minute. The initial rate of absorbance change per minute is
recorded between M1Start and M1End using the least square regression
method and is subtracted from the rate of change in absorbance per minute
recorded between M2Start and M2End using the least square regression
method explained in the section on RATE-A assay type.

M1 Start and M1 These assay points are used to select the time points for measurement of
End initial absorbance for 2POINT and RATE-B assay types. This absorbance
serves as reagent or sample blank. This initial absorbance (or absorbance
change per minute) in these assays is subtracted from the final absorbance
(or absorbance change per minute) that is measured between M2Start and
M2End points. M1Start and M1End can have values from 1 to 36 for 2POINT
and RATE-B assays.

In case of 2 POINT chemistries, the mean of the absorbance’s obtained


between M1Start and M1End is calculated. In case of RATE-B chemistries,
the change in absorbance per minute is calculated between M1Start and
M1End points using least square linear regression method.

M1End should always be equal to or more than M1Start. The difference


between M1End and M1Start should be at least three in case of RATE-B
assay. In addition, M1End has to be less than or equal to M2Start. For
1POINT and RATE-A assays, M1Start and M1End should be programmed as
"0".
M2 Start and M2 It is essential to program M2Start and M2End parameters for all the tests
End and these parameters can have values from 1 to 36. M2Start specifies the
incubation time point. Similarly, M2End is the time until when the
absorbance is recorded for the purpose of concentration calculation.

In case of 1POINT and 2POINT chemistries, the mean of the absorbance’s


obtained between M2Start and M2End is calculated. In case of RATE-A and
RATE-B chemistries, the change in absorbance per minute is calculated
between M2Start and M2End points using least square linear regression
method.

For 2POINT and RATE-B chemistries, M2Start has to be more than or equal
to M1End.

EM 200
User Interface 6-25

Wavelength- This is used to select appropriate primary and secondary wavelengths for
Primary absorbance measurement. The measurement wavelengths are selected from
8 fixed values provided. In case of bi-chromatic measurement, the final
absorbance is obtained by subtracting the absorbance at the secondary
wavelength from that at the primary wavelength. For monochromatic
measurements, use “Select” for secondary wavelength

The analyzer offers a choice of 8 wavelengths with a narrow bandwidth (<8


nm) for programming the wavelength. The choices are 340 nm, 405 nm, 505
nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm.
Secondary When the methodology specifies bi-chromatic measurement for an assay,
user can select a secondary wavelength at which the absorbance can has to
be measured. The selection is made with the pull-down option provided. The
following secondary wavelengths are available in the analyzer: 340 nm, 405
nm, 505 nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm.

If bi-chromatic measurement is not desired i.e. for monochromatic


measurements, keep the choice as “—SELECT—” for the value of the
secondary wavelength.
Control Intervals The Control Interval parameter enables the user to define number of samples
after which the control serum will run automatically. This interval can be
selected between 0 and 1000. For example: Control Interval = 30 means that
control serum will be run after every 30th sample analyzed for that chemistry
Sample Enter the value between 1 to 30 stating the number of repeated sample
Replicates measurements to be performed for the selected chemistry Repeated sample
measurements are usually used to check repeatability. All samples
programmed for this chemistry will be repeated for the programmed number
of times. For routine operation, this parameter is programmed as '1'.
Standard Enter the value between 1 and 3 stating the number of repeated blank and
Replicates standard measurements to be performed for the selected chemistry. It is
recommended to repeat the measurements 3 times. Average of the two
closest replicates would be taken while updating absorbance of Blank and
Standard in the Calibration screen.
Control Enter a value between 1 and 30, stating the number of repeated control
Replicates measurements to be performed for the chemistry. Repeated control
measurements are usually used to check repeatability.
Delta Abs/min This input is used for cancellation of Reaction Linearity Check and is used for
low linearity samples. The user needs to enter the delta absorbance/min for
that test where the Linearity Check should not be performed. Once fed, if the
delta absorbance/min of the reaction for that test is less than the set limit,
then Linearity Check will not be performed.
Linearity Limit % This parameter is applicable only for Rate-A and Rate-B assay types and
monitors the linearity during the reaction. The user can feed any value
between 1% to 30%. If the %Linearity exceeds the specified value in the
Maximum Reaction Linearity, then a LINXX flag is displayed and result will be
declared as NA. This flag is applicable for Patient Samples, Control &
Standard / Calibrators and Not for Blank. Enter “0” in this text box, in case
the check is not desired.
For e.g. if the user specified a value of 5% in the Reaction Linearity
parameter and if the linearity percentage is exceeded, then flag LIN5 will be
issued and result will be declared as NA.

EM 200
6-26 User Interface

Unit Use this option to select unit of measurement for the analytes from a drop
down box. If you do not find the desired unit from the available options, you
can enter a new unit by going to Master > Units screen.

User can define or can create any number of units in Master >
Unit screen.

Decimal Places Enter the number of digits to be displayed and print; after the decimal point of
the test results (photometric / ISE tests) .
Enter the number of digits between 0 and 5.The rounded-off result value will
be used to apply Reference Range Flag to Patient samples & SD Flag, as
applicable
Prozone Limit % Specify the minimum limit for the absorbance at the end of an
immunoturbidimetric reaction as a percentage of the maximum absorbance
observed during the course of a reaction. Prozone limit should be between 0
to 100%. If the percent ratio of the final absorbance (at M2E) with the
maximum absorbance in the time course (up to the point M2E) violated the
prozone limit, a flag P* is issued and result will be declared as NA. If the
option Auto Rerun is selected, the sample is automatically sent for a
Decreased volume rerun. If you want to make sure that the absorbance is
increasing monotonically in the time course, feed a value of 100(%). Enter “0”
in this text box, in case the check is not desired.

Prozone Limit is applicable only for Non-Linear curves.

Prozone Check This displays whether the entered value is an upper limit or lower limit. For
increasing reaction direction chemistries, it is displayed as “Lower” and for
decreasing reaction direction chemistries; it is displayed as “Upper”.
Technical Define the Linearity Limit of the reagents in terms of concentration.
Minimum
For the 1 POINT, 2 POINT, Rate-A and Rate-B chemistries, feed the
minimum and maximum concentrations in the Technical Minimum and
Maximum Technical Limit text boxes respectively.

Enter a value ranging from -99999.99 to 99999.99 indicative of the minimum


technical limit or the linearity limit of the reagent. For end-point chemistries
and rate chemistries, feed the minimum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. Samples that violate this limit are sent for
increased volume rerun. If you do not wish to use technical limit minimum,
feed a zero value.

If the Reaction Absorbance Limit parameter is not zero for


the RATE ASSAYS types, then the Technical Limit
parameters will be masked and vice-versa.

If Tech Limit Min is violated (Final Result < Technical Limit Minimum value), a
flag “TEC-L” is issued and result will be declared as NA. If the option Auto
Rerun is selected, the sample is automatically sent for an increased volume
rerun.

Similarly, if Tech Limit Max is violated, a flag “TEC-H” is issued and result will
be declared as NA. If the option Auto Rerun is selected, the sample is

EM 200
User Interface 6-27

automatically sent for a decreased volume rerun.

Technical Define the Linearity Limit of the reagents in terms of concentration.


Maximum
Enter a value ranging from -99999.99 to 99999.99 indicative of the maximum
technical limit or linearity limit of the reagent. For end-point chemistries and
rate chemistries, feed the maximum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. Samples that violate the programmed technical
limit maximum are sent for Decreased volume rerun. If you do not wish to use
technical limit maximum, feed a zero value.

The Technical Limit (Minimum and Maximum), Reaction


Absorption Limit, and Linearity Limit parameter are
applicable only for Linear and K-Factor curve types.

Technical Limit Minimum or Maximum when ‘0’ (Zero),


indicates that the respective check is not required for the
test.

If the Reaction Absorbance Limit field is not zero for RATE


ASSAYS, then the Technical Limit fields will be masked
and vice-versa.

Curve Type This pull down list is used for defining the calibration curve type for that test.
Reaction This parameter defines the direction of the absorbance change with time for
Direction the reaction mixture. Specify whether the absorbance of the reaction mixture
increases or decreases with time.
React. Abs. Define the absorbance limit of reaction mixture for Serum/Urine samples.
Limit (Reaction Enter an absorbance limit for reaction mixture, depending on the reaction
Absorbance direction (increasing or decreasing). For rate chemistries, the absorbance
Limit) limit is that absorbance at which the substrate depletion is detected. The
absorbance limit entered would be in direct absorbance and not in terms of
delta absorbance per minute. For increasing direction chemistries, enter the
maximum allowed final absorbance before substrate depletion takes place.
For decreasing direction chemistries, enter the minimum allowed final
absorbance before substrate depletion takes place.

If Technical Limits are not entered and if the Reaction Absorbance Limit is
exceeded during the course of reaction then the last point of the
measurement interval (i.e. M2E) is automatically shifted to the point where
this limit has been exceeded to avoid sample rerun phenomenon. This new
point is automatically used for calculation of sample concentration.
.
Also, in the Reaction Curve Screen, the new point would be shown using a
dotted line, stated as Extd. M2E indicating that the extension logic has been
applied to calculate the result.

If no points are available for slope calculation, then Lim0


flag is issued and the result is NA (not declared).

If only one point is available for slope calculation, then


Lim1 flag is issued and the result is NA.

EM 200
6-28 User Interface

If only 2 points are available for slope calculation, then


Lim2 flag is issued along with the result.
.
Maximum permissible entry is 2.5. In case the reaction absorbance check is
not desired, put “0” in the React Abs Limit text box. Extension logic will not
be applied if the Reaction Absorbance limit is set to zero.
.
For rate chemistries, if Technical Limits are entered and if any point between
M2S and M2E exceeds the Reaction Absorbance, AbsLim Flag is attached
and result will be declared as NA. If option Auto Rerun is selected, the test
is sent for a decreased rerun.
.
For end point chemistries, if final O.D calculated exceeds the Reaction
Absorbance, AbsLim Flag is attached and result will be declared as NA. If
option Auto Rerun is selected, the test is sent for a decreased rerun.
Y=aX+b These fields can be used to perform correlation correction so that the results
(Instrument obtained on this analyzer can be matched with those obtained on some other
correlation analyzer. For some assays, the analyzer might give results that are
factor) consistently higher or lower than expected or obtained on another analyzer.
To match the results with the expected results or the results obtained on
another analyzer, a correlation correction can be incorporated in the result
calculations. The equation used for correlation correction is:Y = a X + b

Where, Y is the corrected result


X is the actual result obtained on this analyzer
a is the multiplication correction factor
b is the offset correction factor
When the results obtained on this analyzer are as expected feed
a = 1 and b = 0.
The following plot shows the relation of results obtained on any two
compatible analyzers:
(Here b = 0 and a = 1)

However, when there is a difference in the result between two machines,


correlation correction factors a and b can be calculated and fed to obtain
consistent results on both the analyzers.

Correction factor a, should have values between -999.9 and 9999.9 while
correction factor b should have values between -99999.99 and 99999.99.

EM 200
User Interface 6-29

Reagent Abs Enter the minimum and maximum absorbance values of the reagent.
Min and
Reagent Abs Reagent ABS is checked while running Blank during
Max calibration, if RgtABS value is non-zero for the test in Test
Parameter.

This check is applied for flagging only if RgtAbsMin > 0 for decreasing
direction or RgtAbsMax > 0 for increasing direction in Test Parameter.

Compare the ABS received after adding reagent, say A1 (for 1 Reagent
chemistry, ABS after adding R1 & for 2 Reagent chemistry, ABS after adding
R2) with the Rgt ABS value entered in Test Parameter.

For Decreasing Direction - If A1 (ABS) < RgtABSMin then attach Flag


“RgtAbsMin” to the Blank results.
For Increasing Direction - If A1 (ABS) > RgtABSMax then attach Flag
“RgtAbsMax” to the Blank results.

This check is applicable to -

Patient and control results for only single reagent chemistry.

Blank for single and dual-reagent chemistries.

6.3.2.1.2 Auto Rerun

Tick this check box to set the auto-rerun for a test with appropriate dilution of sample.

Use SET AUTO RERUN button to set the auto rerun for multiple tests.

Click on the desired option to choose Selective test or All test(s) for auto rerun.

If Selective is selected then user can select test(s) from the list below for setting auto-rerun by
clicking on the boxes in the front of tests. Then click on OK button.

If All test(s) is selected then automatically all the tests in the list below will be selected for auto
rerun. Click on OK button to save and apply settings. Click on CLEAR button will close the window
without saving changes.

EM 200
6-30 User Interface

Before selecting the tests for auto rerun, specify the increase and decrease sample volumes for the
test in Test Volumes screen. See Test Volumes for more details.

When auto rerun for test is selected, patient sample will automatically re-run (performed again) on
occurrence of specific flags to the result.

You can set the flags for rerun in Rerun Flags screen, as per your requirement.

Auto Rerun is also selected from PRE-RUN options in Status Monitor screen.

6.3.2.1.3 Copy Test

This button is used to copy the test parameters from one test to another.

To copy, select the required test from the Test panel, and click COPY TEST. Enter a new test name
and click OK. The new test name will be displayed in the Test panel.

Newly copied test will be displayed in Setting > Test Sequence > TEST PROCESS SEQUENCE
based on Open / Closed reagent type.

This button is disabled during run.

Copied test will not display the revision number.

In the closed system, it is allowed to copy only permitted number of open


channel tests (user defined), after that system will prompt a message.

6.3.2.1.4 Upload and Download Tests

Upload button is used to upload the default test parameters and Download button is used to
download the default test parameters in a excel file.

See the following section for more details:

EM 200
User Interface 6-31

Upload Test

Using UPLOAD TEST button, the parameters of the selected test gets uploaded.

Default tests parameters are updated through ENC file format only.

Default test parameters are available in the software CD.

Before uploading parameters for a Default test, make sure that respective test is available in the
tests panel. In case, if test is not available or deleted, it will automatically add the respective
parameter after user confirmation. See the following figure:

Whenever the parameters of the default test are updated using UPLOAD TEST, the revision
number will also get updated.

While updating default Test Parameter from Upload Test Option, if Curve Type changes from
Linear to Non-Linear or vice versa, then Application will ask for user confirmation.

Upload Test for default parameters, overwrites the weak parameters (user editable parameters)
and Reference Ranges only after user’s confirmation.

To upload parameters with different units, select option Overwrite Weak


(editable) Parameters, and then click on Yes. This will upload the
appropriate units and limits.

It is recommended to select option Overwrite Existing Reference Ranges,


while uploading.

After uploading the test parameters, make sure that correct parameters got
updated by verifying version number in the test parameter (which should
match with the version number of kit insert).

The UPLOAD TEST option will be disabled for the ISE tests

EM 200
6-32 User Interface

Download Test

Using DOWNLOAD TEST button, the parameters of the selected test are stored in a xml file and
saved in the C:\MultiXLLOG\DOWNLOAD PARAMETERS. A reagent distributor/manufacturer
may enter a new test from test parameter screen, download parameters and send the xml file to
distribute parameters to their customers.

The DOWNLOAD TEST option will be disabled for the ISE tests.

6.3.2.1.5 Initialize Tests

This button is used to initialize the test parameters from existing ones to default settings. The tests
with similar test names are replaced from default ones and the newly added tests are retained as it
is.

To initialize test parameters, click on INITIALIZE TEST(S) button, select the test(s) to be initialized
and confirm by clicking on OK button. After successfully initializing the tests, following message will
be displayed.

Host Name will not be altered on initialize.

6.3.2.1.6 Special Diluent

Some test chemistries requires special diluents for example HbA1c. Select this option, if any of the
selected tests requires special diluent.

Special diluent is defined through the Consumables screen and its position assigned through Utility >
Reagent Positions screen.

When Special Diluent/Reagent is not available on-board, user can either stop run or mask test and
proceed run

6.3.2.1.7 Test Specific Special Diluent

Follow the steps to use Test-specific Special Diluent for an Open / Closed Channel Photometric
Test:

1) Click Consumables from Main layout screen.


2) Select Consumable Type > Special Diluent from drop down list.

3) Click Consumable > as shown in below screen

EM 200
User Interface 6-33

4) Define different test-specific diluents to be used during run and click Save.

5) Go to Test Parameters > Test Details


6) Select the test from the Test panel list.> Edit.
7) Select (tick) Special Diluent. List of Special Diluent will be available for user to select from
available special diluent. Select the Special Diluent from the drop down list.

8) Also by using Special Diluent > Click , user can edit special diluent for test as shown in
below screen.

EM 200
6-34 User Interface

9) Select the test and Click EDIT. Select the Special Diluent Name from drop down list as show
below

EM 200
User Interface 6-35

10) Click Save.


11) For the Test, if Test specific special diluent is selected, Test Details screen will be displayed as
below

EM 200
6-36 User Interface

If Special Diluent is selected in Test Parameter >Test Details for the particular
test, and test specific special diluent is not defined (**Any** is selected) then any
consumable available under special diluent category will be utilized during
RUN.

6.3.2.1.8 Cuvette Wash

This check box is used to provide a cuvette wash with special wash solution, after performing the
test. This wash is recommended if you are performing special tests like HbA1C, IGG, IGE etc.

The tests for which cuvette wash checkbox is selected, it will be referred to as test requiring cuvette
wash.

Any tests for which the option ‘Cuvette Wash’ is selected, such tests will never
use cuvette#1, during run. Those tests are performed in the next available
cuvettes. During this process, it is indicated by a message ‘SKIP’ in the
progress of the measurement table in Status Monitor.

Ensure that the special wash solution is defined (through Consumable screen).
Once defined, go to the Utility > Reagent Position screen, and define the
position of the special wash solution in the reagent tray.

The cuvette will be washed with special wash solution (different from the wash solution used for probe
wash); after performing the tests requiring cuvette wash. The special wash solution is common for all
the test(s) requiring Cuvette Wash and is not test specific.

EM 200
User Interface 6-37

In case, special wash solution is not available during run then the cuvettes
requiring wash with special wash solution will be skipped and Progress bar of
Status Monitor will show NSWS (No Special Wash Solution).

6.3.2.1.9 Online Calibration

Online calibration is a feature which is used for tracing the reagent bottle change-over. During test
run, when the new reagent bottle is detected, the system will ask for the calibration for newly
detected reagent bottles.

To set online calibration for a test, select this option.

See also:

Set Online Calibration

Online Calibration

6.3.2.1.10 Set Online Calibration

Using this button you can set the online calibration for multiple tests at once. The following window
will be displayed on clicking:

Check Selective radio button for selecting the desired number of tests and All Test(s) for selecting
the entire tests.
Once selected, click OK to confirm.

EM 200
6-38 User Interface

This option will be disabled if the curve type for the test is set as K-Factor.

6.3.2.1.11 Warn After

This text box is used to displays the low reagent warning message for the selected test, during run.
User needs to enter the number of possible tests on which he requires the warning for the reagent.

If the possible number of tests on board for a particular reagent bottle is less
than or equal to the limit entered in this parameters, then it will display the low
reagent volume message with position number in ERROR MESSAGE grid in
Status Monitor screen.

Enter the number between 0 and 200. Default value will be 20.

If this text box is left blank, then 0 (zero) value will be saved and it is considered as warning for low
reagent volume is not required for that particular test.

6.3.2.2 Test Volumes


Test Volume screen is used to perform the following operations:

To specify normal, increase and decrease sample volume

To specify reagent volume and stirrer speed

Copy and view sample volumes

Applying Normal Dilution Ratio of Sample

EM 200
User Interface 6-39

It displays the sample and reagent volumes for a test along with the sample type. It also includes an
option of copying the sample volumes if the SERUM, URINE, CSF, WHOLE BLOOD, PLASMA and
OTHER sample types share the same volumes as Serum sample type.

The user needs to select a sample type prior to defining the Sample, Standard and Reagent Volume
for a test. The Sample and Reagent Volumes may vary for different sample types. However, the
Standard volume remains the same for all sample types.

During calibration run, standard volume of Sample Type ‘Serum’ is read for the
respective test is used.

6.3.2.2.1 Sample Volumes Parameters

This table describes the description of each parameters:

Parameters Description
Normal Specify normal (or default) sample volumes depending on the selection of
sample type.
Increase Specify sample volume (higher than normal) to carry out an automatic rerun of
the sample in case of a hyperactive sample or when the Sample is requested
as increase in the Patient Entry screen.
Decrease Specify sample volume (lower than normal) to carry out an automatic rerun of
the sample in case of a low reactive sample or when the Sample is requested
as decrease in the Patient Entry screen.
Standard Specify volume to be used for calibration that is Blank, Standard and
Volume Calibrators.

EM 200
6-40 User Interface

Dilution Ratio Specify the dilution ratio for normal, increase and decrease sample volume.

A dilution ratio Nx means 1 part of sample and (N-1) part of diluent.

6.3.2.2.2 Reagent Volume and Stirrer Speed

This table describes the description of each parameters:

Parameters Description
RGT-1 Volume Specify volume of reagent to be aspirated for Reagent 1.
RGT-2 Volume Specify volume of reagent to be aspirated for Reagent 2.

This parameter will be displayed for 2 reagent test.

R1 Stirrer The mixture of reagent and sample are mixed by stirrer at three fixed speed that
Speed is Low, Medium and High, as appropriate.
R2 Stirrer The mixture of reagent and sample are mixed by stirrer at three fixed speed that
Speed is Low, Medium and High, as appropriate.
This parameter will be displayed for 2 reagent test.

6.3.2.2.3 Copy Volume

Copy Volume button is used to copy the volumes from current sample type to other sample type(s)
of the selected test.

Use DELETE button, to delete the sample type.

EM 200
User Interface 6-41

Default sample type of a default test can not be deleted. Delete button will be
disabled.

View Volume button is used to view the volumes programmed as per the different sample types.
Use HIDE VOLUMES button to go to previous screen.

6.3.2.2.4 Apply Normal Dilution Ratio of Sample

Tick this option, if you want to pre-dilute standard/calibrators using normal dilution ratio of Sample.

It is available for photometric tests only.

6.3.2.3 Reference Ranges


Reference Range is used to define the normal ranges and panic limit values for the patients for
category such as Male, Female, Child, Other.

It is also used to copy the reference ranges of one sample type to different sample types for the
selected test.

Depending on the reference range selected the Normal Ranges for Male, Female, Child, or Other
would be used accordingly to generate the H and L flags.

You can define reference range through Master menu. See section To add reference range for more
details.

EM 200
6-42 User Interface

This table describes the description of each parameters:

Parameter Description
s
It displays the test as selected from the Tests panel.
Test

It displays the sample type as selected from the list of available Sample Types.
Sample
Type

This drop down list contains different age groups, in addition to DEFAULT. Select
Reference
appropriate age group to define the normal range and panic limits. To add a new age
Range
group, see section To add reference range for more details.
This drop-down list is used to select the category (gender). The available options are:
Category
Default, Male, Female, Child, and Other.
Define the expected values or normal range for Serum/Urine/Other samples being
Normal
assayed. These limits are used to issue H or L flag, which indicate a higher
(Lower
concentration than normal or lower concentration than normal respectively.
Limit and
Normal Normal range values for both Male and Female subjects can be specified for two
Upper different age groups. Additionally, default normal range values can also be defined for
Limit) Male, Female, Child and Other subjects.

The default normal range is used if the age of the patient is not known.

Use this to enter the expected values range for different sample types for different
assays.

For correct H and L flags, the patient’s Category and Gender should
be set before the patient’s sample is analyzed.

Panic Define the minimum and maximum concentration limits for results which are unusual
(Lower and enough, requiring special review by the technician. These values are the upper and
Upper lower panic value limits for specified tests.
Limits)
When the sample result violates the Panic Limit Minimum or Maximum, a flag PANH
or PANL is issued with the result respectively. It is recommended to recheck such
result by repeating the test before reporting.

An automatic rerun of the patient sample, to repeat the test due to Panic Limit
violation, will be performed if:

Auto rerun option is selected for the respective test in Test Details screen

Rerun flag is selected for PANH and PANL in Rerun Flags screen

Auto rerun option is selected from PRE-RUN Options in Status Monitor screen

When PANH or PANL flag is issued to a result of patient sample, the "same" (re)run
will be performed. A same rerun means using the sample volume same as it was
programmed in the first determination.
For example, if the sample was programmed for a normal volume run then the rerun
too will be performed using normal sample volume.Similarly, if the sample was

EM 200
User Interface 6-43

programmed for Decreased or Increased volume run, then the rerun will be performed
using a Decreased or Increased volumes respectively. The rerun result is flagged “#” to
indicate a rerun.

6.3.2.3.1 Copy Reference Range

This button is used to copy the reference ranges from current sample type to other sample types.
Multiple sample types can also be selected.

6.3.2.3.2 View Reference Range

This button is used to view the reference ranges programmed as per the different sample types. Use
HIDE VOLUMES button to go to previous screen.

6.3.3 Profiles/Calc
Profiles/Calc is used to perform the following operations:

To create profile

To create calculated item

See the following screen.

6.3.3.1 Profiles
Profiles screen is used to create test profile. Profile is a predefined group of tests.

Once created, they are used for selection through a single click, during the patient entry details in
the Patient Entry. One or more profiles can be selected for a patient at the same time. See section
Create Profile.

EM 200
6-44 User Interface

6.3.3.2 Calculated Items


Calculation item screen is to define a calculation item involving one or more chemistries (up to 5
chemistries). It is also possible for the user to define the formula as per your requirement using the
Calculation Formula screen.

If these calculation items are selected in the Patient Entry screen, then the test(s) required to
calculate the value are selected (scheduled) automatically. The calculated items are printed along
with the test result in the Patient Report printout.

EM 200
User Interface 6-45

This table describes the description of each parameters:

Parameters Description
Calculated Define the name of the calculated item, up to 5 characters. This name will be shown
Item in a separate grid in Patient Entry screen.
Report Enter the full name of the calculated item (i.e., A/G ratio). This name is printed on the
Name patient report.
Formula The user can select the desired calculation formula from the drop down list. If new
formula is required, you can create your own formula using Calculation Formula
screen.
Unit Select the unit to be printed along with the calculation Item.
Host Name Enter the name of the calculated item, as defined in LIS (for host communication).
This text box is visible only if Host connection is activated from System Parameters
screen.
Decimal
Enter the number of decimal places for the calculated item.
Places

Once, the formula is selected, the user can select the tests associated with the
calculation item. Additionally, the user can also use another calculation item (nested
calculation items) for defining a new calculation item.

The user can select the normal ranges or panic limits (if desired) for the calculation
item depending on the sample type selected. Normal Range options are available for
Default, Male, Female, Child or Other types.

CEC Calculation item is present by default. For this calculation item, only the Report
Name, Unit, Decimal Places and Normal Ranges can be modified. Test A can also be

EM 200
6-46 User Interface

selected and Test B will be displayed same as Test A.

If CRE is deleted from the test parameters screen, then CEC is not visible in
calculated items.
When CRE is again initialized through the test parameter screen then a
Activate CEC button is displayed on the Calculated items screen. On clicking,
CEC is again visible in the Calculated Items.

6.3.4 QC/Calibration
QC/Calibration is used to perform the following operations:

Scheduling consumables

Viewing calibration curve and perform curve related operations

Monitoring of the performance of the analyzer

Twin plot graph

Viewing control data and graph for two different controls

See the following screen.

EM 200
User Interface 6-47

6.3.4.1 Schedule QC/Calibration


Schedule QC/Calibration screen is used to schedule consumables (Blank, Standards, Calibrators,
and Controls).

See the following procedure for scheduling consumable in more details:

Scheduling Standard

Scheduling Controls

Scheduling Blank

Scheduling Calibrators

6.3.4.1.1 Scheduling Standard

Use the following procedure for scheduling:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position from the Position drop-down list. This drop-down will also display
the last scheduled consumable name at respective position. This consumable name is
retained for a position till a patient sample is defined on that position.

3. Select appropriate container from the Container Type drop down list.

4. Select consumable type as 'Standards' from the Consumable Type drop down list.

5. Select appropriate consumable from the Consumable drop down list.

EM 200
6-48 User Interface

6. Select the required Lot No. of the selected consumable. The last defined lot number appears
as selected, by default.

On selecting the lot number, a grid with the list of tests for the selected consumable appears
on the right side of the screen, where in option of auto dilution and dilution ratio can be
selected for non-linear chemistries.

7. On selecting AutoDil and DilRatio, click OK.

Depending on the concentration and the DilRatio (dilution ratio) selected for the test, the
number of serial dilutions possible will be displayed in another grid as shown in the following
figure.

Further dilution numbers can be selected using this grid.

EM 200
User Interface 6-49

If the dilution ratio is not selected then default dilution ratio will be applied to
the test. The default dilution ratio is 2.

8. Click OK.

On clicking, the details will be added in the required position as shown in the following figure.

.
Auto-dilution is possible for non-linear curves.
Auto-dilution is not possible for the curve types K-factor and Linear. The gray
background color in the column AutoDil indicates that auto-dilution is not
possible for the respective test.
Auto-dilution is not available for selection if option ‘Apply Normal Dilution
Ratio of Sample’ for a test is selected in Test Parameter > Test Volume.
If Auto dilution is scheduled for a test then Normal Dilution Ratio cannot be
applied for that test. In this case, you have to clear the auto dilution schedule.

9. Click on SCHEDULE button.

On clicking the SCHEDULE button, the standards will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards /
Calibrators are not scheduled.

While performing the Blank, Standards, Calibrators and Controls that are scheduled, the
sample and reagent volumes defined (in Test Parameter > Test Volume) for Sample Type
Serum is used. This is indicated by Serum in the column Sample Type.

EM 200
6-50 User Interface

To clear the schedule CLEAR POSITIONS button can be clicked. On clicking, following
screen is displayed to either clear selected positions or all the positions.

Clear position button does not clear the sample positions. Only scheduled
Blank, Standards, Calibrators and Controls will be cleared.

Hence, either a particular position is selected or CLEAR ALL option is checked.

6.3.4.1.2 Scheduling Control

Use the following procedure for scheduling the controls:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position. If the position is occupied, then the user can view it in the grid
placed on the bottom side of the screen. This drop-down will also display the last scheduled
consumable name at respective position. This consumable name is retained for a position till a
patient sample is defined on that position.

3. Select appropriate container type from the Container Type drop-down list.

4. Select Controls from the Consumable Type drop down list.

5. Select appropriate control from the Consumable drop-down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

On selecting the lot number, grid on the right side of the screen displays the available tests
for the selected consumable for running the QC and test Profiles grid with available profiles.
Sample type (Serum/Urine) will get displayed accordingly in sample type with respect to
selected control for the test See figure below. See figure below.

EM 200
User Interface 6-51

You can create your own profile through Profiles screen.

7. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), and then click on the OK.

On clicking, the details will be added in the required positions as shown in the following
figure.

EM 200
6-52 User Interface

8. Click on SCHEDULE.

On clicking, control will be scheduled.

9. To clear the schedule, click CLEAR POSITIONS button.

If a position was used during earlier calibration run, then consumable name
is also displayed along with the position number in ‘Position’ drop down list,
till the new patient sample is defined on that position. See figure as shown
below.

These positions can be reused by re-selecting it for a new schedule.

EM 200
User Interface 6-53

6.3.4.1.3 Scheduling Blank

Use the following procedure for scheduling blanks:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position. User can view the occupied sample positions in the grid placed on
the lower half of the screen.

3. Select the appropriate container type from the Container Type drop-down list.

4. Select Blank from the Consumable Type drop-down list.

5. Select appropriate blank from the Consumable drop down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

On selecting the lot number, grid on the right side of the screen displays the available tests
for the selected consumable for running the QC and test Profiles grid with available profiles.
See figure below.

The screen consists of three column:

Tests

Selective

Curve Type

EM 200
6-54 User Interface

Tests: Tick the check-box to select (schedule) the test.

Selective: Tick this check-box to schedule Selective Calibration (perform only blank to
derive the calibration curve) for the test.

Curve Type: It displays the curve type for the test.

The check-box with Gray color in the Selective column indicates that the
test may not be Calibrated or Already Scheduled or Unsuccessfully
Calibrated. In such case, selective calibration option is not available.

Schedule Full calibration, if not already scheduled in any group.

7. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), click on OK.

On clicking, the test(s) will be added in the selected positions as shown in the following
figure.

EM 200
User Interface 6-55

Test(s) scheduled with Selective Calibration are marked with Asterisk (*)
symbol under column Pos.

7. Once the blank are defined, click on SCHEDULE.

On clicking, the blank will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards/
Calibrators are not scheduled.

8. To clear the schedule, click on CLEAR POSITIONS button.

6.3.4.1.4 Scheduling Calibrator

Use the following procedure for scheduling:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position from the Position drop-down list. This drop-down will also display
the last scheduled consumable name at respective position. This consumable name is
retained for a position till a patient sample is defined on that position.

3. Select appropriate container from the Container Type drop down list.

4. Select appropriate consumable type, Calibrator, from the Consumable Type drop down list.

EM 200
6-56 User Interface

5. Select appropriate consumable from the Consumable drop down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

7. On selecting the lot number, a grid with the list of tests for the selected consumable appears
on the right side of the screen, where in option of auto dilution and dilution ratio can be
selected for non-linear chemistries. See figure below.

8. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), Select auto dilution and dilution ratio, as applicable and then
click OK.
You can create your own profile through Profiles /Calc > Profiles.

9. Following figure shows that tests are selected through available profile ‘LIPID’.

EM 200
User Interface 6-57

10.On clicking OK, the tests will be added in the selected positions as shown in the following
figure.

11.Click on SCHEDULE.

12.On clicking, the Calibrator will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards/
Calibrators are not scheduled.

EM 200
6-58 User Interface

6.3.4.2 Calibration
Calibration screen allows to view calibration curve and to perform curve related operations. Lot
number and concentration for that test are defined in the Consumables screen.

Test Revision (if available) will be displayed on the screen in red color as seen in
the above image.

This Revision shall be printed on the Calibration Report as well, as shown below;

EM 200
User Interface 6-59

After the calibration run is completed, absorbance values obtained by the analyzer are updated in
the Calibration screen along with the K-Factor. The date and time of calibration is also updated.

For any 2-Point chemistry, if the concentration obtained by the calibration curve
is negative (below zero), then the output test result will be in multiple of 0.1 (or
zero), based on decimal places set for the test.

One of the last five calibration curves can also be selected for use in result calculations.

Use previous or next calibration can be viewed using navigation buttons.

For using the calibration on the screen, use Set Latest Calibration button. On clicking, a warning
message will be displayed for user.

In order to view the calibration details for a test in use, the user needs to select the test from the
grid.

Before using Set Latest Calibration, make sure that calibration is performed with
the current Test Parameters. Result may not be correct, in case parameters were
different.

To print the calibration table along with the calibration graph, click on PRINT button.

If there has been some error during calibration (like reagent absent or
calibrator absent), the calibration data for which reagent, blank and calibrator
was present is updated. However, Unsuccessful Calibration message will be
displayed.
Normally calibration requires 3 replicates of blank and 3 replicates of
calibrator for successful calibration. The calibration will be successful; if there
is at least one replicate of blank and one replicate of calibrator are processed

EM 200
6-60 User Interface

successfully.
If RgtAbsMin/Max Flag is issued to the Blank measurement then the respective
replicate of Blank will not getting updated to Calibration Table.
If at least one replicate of blank measurement is available without RgtAbsMin/
Max flag or any instrument related flag, then calibration will get proceed as
successful and calculate the result.
Auto copy calibration will get copied a successful calibration if at least one
replicate result is available for all the (calibrator concentrations) points.

This table describes each parameters on the screen:

Parameters Description
Test It displays the test name.
Last
Calibration It displays the date on which the calibration of the test was performed lastly.
Date
Curve Type It shows the curve type selected for the test in Test Parameters > Test Details
screen.
Calib Expiry It allows the user to enter the Calibration Expiry Limit for that test in days. This limit
Limit is a decremented counter that commences after calibration for that test is done. The
Test, for which the calibration is expired, is highlighted with Pink color in the Patient
Entry screen.
Acceptable For Linear curves, Use this text-box to enter the acceptable limit allowable for
Limit % deviation of Factor between 2 calibrations. Default value is 15%. The user can feed
any value between 0% to 20% and is expressed in terms of percentage. During run,
when the calibration factor differs by the specified acceptable limits with respect to
the earlier factor, system will notify user about Calibration out of range for the test.
However, this new calibration will still be considered as successful.
The acceptable limit input text box will be disabled for curve
types K-Factor and Non-Linear.
Acceptable limit input is accessible only if the Calibration for the
test with linear curve is performed once successfully.
When the value is set to 0 (zero), the comparison of the factors is not done. The
comparison is made on basis of the factor obtained. The new factor obtained is
compared with the old one and based on the acceptance limit entered; the new
calibration details are updated. If the value falls outside the acceptable limits, then
the old calibration details are kept and the new details are updated with message
Factor out of Range. This textbox is applicable only for Linear curve types.
Calibration It displays the date on which the calibration, currently displayed on screen, for that
Date test was performed. The display changes if previous calibration is selected.
K-Factor This parameter will be displayed only when the curve type for the test is selected as
K-factor in Test Parameter > Test Details. It is used to enter the known factor for the
required test. The value should be non-zero number between -99999.99 to 99999.99.
R1/R2 Lot No It displays the Reagent Manufacturing Lot Number along with barcoded lot No if
available (system pack scanning) in Reagent Position used for calibrating that test.
If the test has only one reagent, then only R1 Lot No will be displayed. Similarly, if
the test has two reagents, then R1 Lot No, R2 Lot No, text-box will be displayed.

This table describes each column on the grid:

Parameters Description

EM 200
User Interface 6-61

Pos It displays the Calibrator, Standard or Blank position; till the position is not utilized
for scheduling any other sample.
Consumable It displays the consumable name (Blank, Standard, or Calibrator) used for
calibrating that test.
Conc It displays the concentration of the blank or the calibrator used.
Abs This column indicates the absorbance values that are automatically obtained by the
analyzer after the calibration is carried out.
Lot No. It displays the Lot Number of the consumable used for Calibration of that test.
Factor It displays the Calibration Factor obtained for the selected test

See the available buttons and their functionality:

Set Latest Calibration: Use Prev and Next buttons on the screen to view the previous or next
calibration record, and then select any one calibration which should be used for patient result
calculation. Click on Set Latest Calibration button to set the selected calibration and use the same
for calculating results.

Copy Calibration: This button is used to manually copy the calibration details across test(s) with
same assay type and specific curve type (either both liner either both linear or both non-linear
requiring same number of calibrators); sharing the same Reagents.

For Automatic Copy Calibration, you must activate the Automatic Copy
Calibration option from the Settings > System Parameters screen.

Selective Calibration: Selective calibration, also known as One point to Multipoint Calibration or
Normalization of Calibration Curve is used when a user wants to use only a reagent blank for
calibration. It is applicable for all curves except K-factor. The user can schedule and perform this type
of calibration for individual chemistries.

On clicking this button, two options are available under Calibration Type for the selected test:

Full: This option is the default selection through which you can schedules the entire
calibration set again.

Selective: This option is used to select blank available and then it uses the slope method to
correct the other factors.

Repeat Calibrators: This button is displayed for the non-linear test on which the last calibration is
performed within last 24 hours. Using this button, errors of point in a non-linear calibration graph, can
be corrected by repeating the single/multiple calibrators, instead of repeating the entire calibration.
For example, see the following figure.

EM 200
6-62 User Interface

On clicking this button, list of calibrators processed during calibration will be displayed.

Select the appropriate calibrator(s) to be repeated by ticking the check-box at the respective row and
click SCHEDULE button. One or multiple calibrator(s) used to derive the curve can be selected to
repeat.

Schedule of such calibrators will be displayed with Asterisk (*) symbol next to test in QC/Calibration
> Schedule QC/Calibration screen. Asterisk (*) symbol indicates selective calibration with Blank/
Repeat calibrator.

EM 200
User Interface 6-63

This button is not available for the test whose curve type is linear or k-factor and
for non linear test more than 24 hours old.

6.3.4.3 QC Data
The QC (Quality Control) screen is used for day-to-day monitoring of the performance of the analyzer.

It allows you to monitor the following:

Accuracy of the analysis (i.e. whether the values obtained are correct)

Precision (i.e. the reproducibility – whether the same values are obtained when the sample is
analyzed repeatedly)

The QC Data is useful for viewing the QC Results in Graphical format. QC Rules implementation has
been on QC Results in the QC Data and is marked with a respective color to indicate which rule has
been violated for that test.

Also, for each QC results you can:

Enter remarks

Exclude selected QC points permanently

View QC graph with new laboratory mean

The user should either rerun the controls again or recalibrate the test and run the controls.

EM 200
6-64 User Interface

To open the screen, go to QC/Calibration > QC Data screen. The following screen is displayed as
shown below:

Following are the steps to view the results and chart:

1. Select Date From and Date To. The user can select the same date for viewing the daily QC or
select a range for viewing the Monthly QC.

2. To select the test, click on dotted button near the Test text-box, a small window will open up
through which the test can be selected.

3. Select the control level using dotted button near Control text-box and hence control name for
which results and graph should be displayed. If the selected Date From and Date To are
same, all the control results can be seen. But if the user has selected Date From and Date To
different, then only one control results can be seen at a time.

Lock button is provided to keep the particular level of control constant.

4. Lot number for a control can be selected from the Lot No. drop-down list.

5. Once the above selection is done, click on DATA button to view the results for the selection in
the result grids.

EM 200
User Interface 6-65

6. Batch No. will be displayed for selection, if the date range selected is same. See the following
figure.

If the date range selected is from “x” period to “y” period (see Figure A), then,

EM 200
6-66 User Interface

X-bar Calculation grid signifies the following:


Level: Displays the test control levels.
N: Number of days the control run is performed.
Avg: Average of the test result values over the period specified.
SD: Standard Deviation for specified period.
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum day’s average (over specified period).

R - Calculation grid signifies the following:


Level: Displays the test control levels.
N: Number of days the control run is performed in replicates.
Avg: Average of range over the period specified.
SD: Standard Deviation for specified period.
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum range value over specified period.

If a single date is selected (see Figure B ), then the X-bar Calculation grid signifies the
following:
Level: Displays the test control levels.
N: Number of replicates the control is run during that day.
Avg: Average of the test result values on that day.
SD: Standard Deviation for that day
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum result (if replicates are done)

If a single date is selected, then R Calculation is not applicable.

In the QC results, Result column will be highlighted in different colors, if any of the default
QC rules stated below is violated. See the following figure for example.

The above six rules are given different colors to highlight the result or the point on the graph when the
corresponding rule is violated. To see the QC rules, just place the pointer over any of the item, a pop
message will be displayed with description.

The user needs to check the control result after the control run is completed and hence take
corrective action whether to continue with patient samples or not. Or else perform calibration again
and re-run the controls to check if the results are proper.

Buttons for quick selection

EM 200
User Interface 6-67

: This button is used, if you want to apply user-selected QC rules in


results. By default all rules are ticked. Un-tick rules that are not required and click this
button. For example, see the following data after clicking this button.

: This button is used for applying filter for QC results to be excluded,


based on deviation flag selection. On clicking this button, all QC results having selected
deviation will be ticked which can be excluded using Excluded QC Results button. For
example, see the following data after clicking this button.

Entering remarks for QC points

Click on the remark icon to enter user remarks, such as, reasons or corrective action taken for
outlier QC results (if required). See the figure as shown below.

EM 200
6-68 User Interface

Lab mean calculation is also available for ISE controls results.

Excluding QC points permanently and view proposed graph with lab mean

QC points can be excluded by using Exclude QC Results and Exclude and Apply Lab Mean, as
per user requirement.
To do this, select the required QC points to be excluded, and click on the button, as appropriate.

See the functionality of buttons used for this purpose:

: This button is used to view the data after excluding the selected
QC results. After confirmation it will exclude user selected QC points permanently.

: This button is used to see the preview of graph with new proposed
lab mean excluding user selected QC points.

In the graph, small rounded circles indicate excluded QC points. See the following
example.

: This button is used to view the data after excluding


selected QC results after confirmation, and the proposed lab mean is applied to QC results
for the selected date range and future dates till user calculates new lab mean. Proposed lab

EM 200
User Interface 6-69

mean is calculated according to the user required QC points and displayed in lower left
corner of the screen. See the figure below.

New Standard Deviation (SD) will be only applied to future QC results


based on user choice. A confirmation message will be displayed as
shown below.

Once lab mean is calculated for the selected control results, it can not
be recalculated. Those results are disabled and indicated with gray
background.

When the lab mean is applied, the new lab mean will be displayed on top right of the
screen with date on which it is applied. See the following figure.

EM 200
6-70 User Interface

Use GRAPH button to view graph with new lab mean or manufacturer mean, as
appropriate.

In Result Reprint screen, data is displayed with respect to new lab


mean and SD (once calculated). Excluded QC results are indicated
with “~ ” symbol with gray color background for Control data.

Select option QC Rules in Graph to view the QC rules in graph.

Above buttons (Exclude QC Results, Proposed Graph and Exclude


Apply Lab Mean) will be disabled, if the available non excluded QC
points are less than the value entered in option Min QC Result for Lab
Mean in Settings > System Parameters.

Other buttons available on the screen

EXPORT: User can click on EXPORT button to export the data to an excel sheet.

PRINT: User can click on PRINT button to print the data.

6.3.4.4 Twin Plot


This feature of Quality Control helps the user to compare the trend in the values of the different level
of controls for any chemistry.

It provides a running check on the linearity of instruments and integrity of calibration.

For Twin Plot, two levels of control samples with different lot numbers are required. Period (date
range) and Test name needs to be selected before viewing the twin plot.

See the following procedure to view the results and chart:

1. Select Date From and Date To: The user can select the same date for viewing the daily
graph or select a range for viewing the monthly graph.

EM 200
User Interface 6-71

2. To select test, click on dotted button near the Test text box, a small window will open up
through which the test can be selected.

3. Select Control for X and also for Y and then click on Show Lot.

4. Select Lot No. for that Control X and also for Y from the list displayed.

5. On selecting Lot no, the following data will be displayed:

a. Level – Level of the control selected.

b. Target Mean – Target Mean of the selected lot.

c. Target SD – Target SD of the selected lot.

d. N – No of Days is date range is selected or no of replicates if single date is selected.

e. Mean – Mean of Daily averages if date range is selected Or Mean of all the replicates for
the single date selected.

f. SD – Standard Deviation of Daily averages if date range is selected Or Standard Deviation


of all the replicates for the single date selected.

g. CV - Coefficient of Variation calculated from Mean and SD.

h. Range - Range of Daily averages if date range is selected Or Range of all the replicates for
the single date selected.

7. Once the above selection is done, click on DATA button to view the results for both the
controls selected.

EM 200
6-72 User Interface

If same lot and same control is selected for control X and control Y then a
warning message "Same Control Lot selected" is displayed.

8. Click on GRAPH to view the graph for both the controls selected. The daily averages for
Control Y are plotted (on the Y-axis) against the daily averages for Control X (on the X-axis).

EM 200
User Interface 6-73

9. Un-check the Show Date check box, if you do not want to display the date on the marked
points.

10.Use EXPORT to export the data to an excel sheet.

11.Use PRINT to print the data and graph.

6.3.4.5 QC Graph
This screen is used to view control data and graph for two different controls. To view the control data,
select the required date range and other details, and then click DATA.

Click GRAPH to view data in a graphical format.

Use EXPORT to export the data to an excel sheet.

Use PRINT to print the graph.

Lock button is provided to keep the particulate level of control constant.

EM 200
6-74 User Interface

EM 200
User Interface 6-75

6.3.5 Consumables
Consumables screen is used to define various consumables such as Reagents, Blank, Calibrators,
Controls, Diluent and Wash, including their name along with their respective lot numbers,
reconstituted dates, concentration and on-board stability of the test are defined in the same screen.

Also, it is used to upload and download consumables. See section Upload and Download for more
details.

See the following procedure to define consumables in more details:

Defining Reagents

In the closed system, user is allowed to define or add only permitted number
of open channel reagents (user defined), after that system will prompt a
message.

1. In the Consumable screen, select the Consumable Type to Reagents.

2. Now click on the button next to the Consumable box.

On clicking, the following screen will be displayed.

EM 200
6-76 User Interface

3. Enter the appropriate Reagent name, Reagent Code, and Reagent Type.

Reagent Enter the name of the reagent.


Reagent Code Enter the unique Test Code.
This is the 4th and 5th digit on the Reagent Barcode Label on the
bottle. It is used to identify the Reagent and update reagent position
after Reagent Barcode scan.

For closed channel reagents, reagent code should be a unique 2-digit


number in permitted range.

For open channel reagents, reagent code should be a unique 3-digit


number in permitted range.
Reagent Type Select whether the reagent is single reagent or dual reagent. The
available options are:
R1
R1, R2

In the closed system, user is allowed to define or add reagent code only in
the permitted range, otherwise system will prompt a message.

4. Click SAVE to save the details.

On saving the details, the reagent will be added in the list of reagents as shown in the
following figure.

EM 200
User Interface 6-77

6. Double click on the Reagent name from the list of reagents. The selected reagent will be
displayed. See the following figure:

7. Click on the ADD button.

The following screen will be displayed.

EM 200
6-78 User Interface

8. Now enter the manufacturer name from the manufacturer drop-down list. See section
Manufacturer for adding manufacturer name in the list.

9. Enter the lot number in the Lot No text box.

10.Enter the expiry date of the reagent in the Expiry Date list.

11.Enter the on-board stability and unit in Onboard Stability text-box and Unit drop down list.

12.Select the Reagent Type check-boxes to be used, as required. The Reagent Type
check-boxes will be pre-selected, if it is already defined while entering the details for new
reagent.

13.Once the above details are entered, click on SAVE to save these details.

The reagent will be added and displayed on the grid.

EM 200
User Interface 6-79

To modify details for a reagent

Use the following procedure to edit the details for a reagent:


1. To edit the reagent details, go to Consumable screen, select the Consumable Type as
Reagents and click on the button.

On clicking the following screen will be displayed.

EM 200
6-80 User Interface

2. Now select the required reagent from the list.

3. Click EDIT.

On clicking, the following screen will be displayed for editing.

4. After editing the details and click SAVE. The details will be saved.

Lot details can be edited directly by double-clicking on the required lot


from the main Consumable Screen.

Following table gives a brief explanation on the different fields in the grid.

Parameters Description

Manufacturer Select the Reagent Manufacturer from the drop-down list.


A Manufacturer from Master > Mfg screen.

Stock Over Check this Stock Over box when the stock of the consumable lot is
completely utilized.
Lots marked as Stock Over will not appear in the Lot Selection List -
While defining Reagent Positions in the Utility > Reagent
Position screen
While scheduling Calibration and Controls from QC/
Calibration > Schedule QC / Calibration screen.
Note: In case, Stock Over is not ticked for a Lot; then the Lot will be
excluded from the selection list after its expiry date.
This check-box is available only in Edit mode and not while adding a
Lot.

EM 200
User Interface 6-81

Lot No Enter the lot number of the reagent.

Lot Status Lot status as Active or Inactive is displayed based on the Expiry Date
defined for the Lot. Expired Lot is displayed as Inactive.

Expiry Date Select the expiry date of the Reagent lot.

On-board Stability Enter the On-board shelf life of the reagent.

Unit Select the On-board Stability unit, as appropriate.


Options available are Hours and Days.

Reagent Type Select whether R1 and/or R2 is received for the selected Lot number.
In case, lot numbers are different for R1 and R2, then define both the
Lots for R1 and R2 appropriately.

Following are the description of buttons available on the screen.

PRINT This button is used to print the list of reagents.


SAVE This button is used to save the reagent details.
EDIT This button is used to edit the details of the selected reagent.
CLEAR This button is used to cancel add / edit mode.
DELETE This button is used to delete the reagent

Default loaded Erba reagents can not be deleted.

Defining Blank

1. In the Consumables screen, select Consumable Type as Blank.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Blank text box and select the tests associated with the blank, and then
click on SAVE.

EM 200
6-82 User Interface

Once saved, the user can double click on the blank name for which he wants to add lot
details. This will close the window "Consumable" and take to "Consumable" main screen.
One can also leave the screen by clicking on "X" when one do not want to add lot and go
back to Consumable screen.

4. Click ADD from the main screen, the following screen will be displayed.

EM 200
User Interface 6-83

Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No and concentration for the selected blank.

The permissible concentration range for the selected Blank is between 0 to


99999.990

7. After entering the details, click SAVE.

8. On clicking, the blank will be saved and displayed on the Consumable screen, when the
Blank is selected.

Defining Standard

1. In the Consumables screen, select Consumable Type as Standard.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Standard text box and select the tests associated with the standard,
and then click on SAVE.

Once saved, the user can double click on the standard name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one do not want to add lot and go back to
"Consumable" main screen

4. Click ADD from the main screen, the following screen will be displayed.

EM 200
6-84 User Interface

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the concentration for the selected standard.

The permissible concentration range to define a Standard is between 0.001


to 99999.990

9. After entering the details, click on SAVE button.

10.On clicking, the blank will be saved and displayed on the Consumable screen, when the
Standard is selected.

Defining Calibrators

1. In the Consumables screen, select Consumable Type as Calibrator.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Calibrator text box and select the tests associated with that calibrator,
and then click on SAVE.

EM 200
User Interface 6-85

Once saved, the user can double click on the calibrator name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one does not want to add lot and go back to
"Consumable" main screen.

4. Click ADD from the main screen, the following screen will be displayed.

EM 200
6-86 User Interface

Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the concentration for the selected calibrators.

The permissible concentration range to define a Calibrator is between 0.001


to 99999.990

9. After entering the details, click on SAVE button.

10.On clicking, the calibrator will be saved and displayed on the Consumable screen, when
Calibrator is selected.

Defining Controls

1. In the Consumables screen, select Consumable Type as Control.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Control text box, Select the control type from Type drop down list and
select the Level from the available options (Low, Normal, High, and Very High).

4. Select the tests associated with the control, and then click on SAVE.

EM 200
User Interface 6-87

Once saved, the user can double click on the control name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one do not want to add lot and go back to
"Consumable" main screen

4. Click ADD from the main screen, the following screen will be displayed.

Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the mean value for the selected tests in the Mean column.

CV will be automatically calculated, if the Mean and SD are entered for the test. Similarly,
SD will be calculated if Mean and CV are entered.
For example: To calculate CV, select option SD and enter the mean and standard deviation
value for the test in the Mean and SD column. On saving the control, the CV will be
calculated and displayed in the CV column.

EM 200
6-88 User Interface

Lab Mean column is not user editable. Manufacturer’s mean will be


automatically stored as lab mean, till the lab mean is calculated by the user.

9. After entering the details, click on SAVE button.

On clicking, the control will be saved and displayed on the Consumable screen, when
Control is selected.

Defining Diluent

1. In the Consumable screen, select the required diluent from the Consumable Type.

2. Click on dotted button and enter the diluent name in Diluent text box in Consumable window.

3. Click SAVE.
Once saved, double click on the diluent name for which he wants to add lot number. This will
close the window "Consumable" and take to Consumable screen.

4. Click ADD button.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter the lot number, and then click SAVE.

Two separate positions are provided on the instrument for placing the
diluents. Also, diluents and wash can be placed on any position of the
Reagent Tray.

Defining Wash

1. In the Consumable screen, select the required wash from the Consumable Type.

2. Click on dotted button and enter the wash name in Diluent text box in Consumable window.

3. Click SAVE.
Once saved, double click on the wash name for which he wants to add lot number. This will
close the window "Consumable" and take to Consumable screen.

4. Click ADD button.

EM 200
User Interface 6-89

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter the lot number, and then click SAVE.

User is not allowed to define system solutions (wash, diluents, etc.) for reserved
reagent codes.

6.3.5.1 Upload and Download


The consumable details can be uploaded or downloaded using UPLOAD and DOWNLOAD button.
These buttons are available in the Consumable screen.

The distributor will generate the files containing consumable details (like Calibrator and Control lot
information along with concentration, target values etc) using DOWNLOAD. The distributor will send
this generated file to the customers along with consumables. The customers will then upload the
given consumable file using UPLOAD.

See the following procedure:

Downloading Consumables

1. In the Consumables screen.

2. Define appropriate consumables with their respective lot details.

3. Click DOWNLOAD.

4. On clicking, the Download Consumables window will be displayed which contains the list of
information about all the active (non-expired) lot(s) of consumables as shown in the following
figure.

By default, all consumables will be selected for download. You can select the required
consumables by un-checking the check-box and then selecting it again as per your
requirement.

EM 200
6-90 User Interface

.
At least one consumable lot should be selected to download.

5. Once the required consumables are selected, click OK.

The will generate a XML file containing the consumable information with their respective lot
details (only for active lot). This file is automatically saved in the appropriate location on your
computer. The file name and the location will be displayed on the Indication text box as
shown below:

Uploading Consumable

Before uploading the consumables, you should have access to the


Consumable screen.

1. In the Consumable screen, click UPLOAD.

On clicking, the following window will be displayed.

EM 200
User Interface 6-91

2. Now select the required consumable file from the appropriate location, and then click Open.

On clicking, the system will read and verify the data before uploading the file. The consumable
information will be uploaded only if the lot number is not found. This means, if the system
detects that the consumable lot with all or some test(s) already present in the database
(uploaded earlier or defined manually), then it will skip those test(s) without comparing and
changing its respective information (such as Expiry date and Target value(s), and It will upload
only those test(s) along with their respective details that are not available in the database.
.
In case, any error occurs during verification or upload, the error message will be displayed and
data from the file will not get uploaded to database.

The following error message will be displayed during upload if:

Incorrect xml file is selected (other than the one generated using Download option) for
upload, then the error message will be displayed and upload will not proceed.

The XML file (generated using Download option and received) format is altered, then the
following error message will be displayed “Error in Uploading Consumables” in the
Indication text box, as a result the upload data will be terminated.

3. On successful upload, a message “Consumables Uploaded Successfully” will be displayed.

To Verify the Uploaded Consumables

EM 200
6-92 User Interface

Once the consumables are uploaded, you should verify each of the consumables lot.

From the Consumable screen, select the appropriate consumable (Blank, Standards,
Calibrators or Controls) from the Consumable Type dropdown list, and verify the uploaded
consumables.

6.3.6 Status Monitor


Status Monitor shows you the status of samples during batch run, reagent level in bottles, reaction
curve, and position of the scanned reagents and samples. Much of the information is presented
graphically.

The Status Monitor screen has four main options, each of which shows the state of a particular part
of the system.

See the following section for more details:

SAMPLE TRAY

REAGENT TRAY

REACTION CURVE

BARCODE SCAN

Options and command buttons available on the screen:

Pre-Run Options

EM 200
User Interface 6-93

Work List

Add Sample and Reagent (Barcoded)

ISE Pack

Refresh Position

Scan Pack

When starting the batch RUN, if dome is open, then pre run activities will not be
started and error message with alarm beep will be displayed in error display
grid.

Ensure to close dome properly before proceeding.

There are two levels of dome opening, at Level 1 opening there will be warning
message and alarm whereas at Level 2 opening sampling will be stopped
immediately.

During Maintenance activity this screen is disabled and can be accessed by the
user only upon its completion.

In closed system when click on button, a card expiry warning message


will get displayed with expiry details of open test counts if card is expiring
soon. Click to close the warning message.

During pre-run activities, if user is on some other screen (e.g. doing patient entry)
then at the completion of pre-run activities, screen may get switched to 'Monitor'
screen for some time to get user's attention but it will automatically come back
to earlier screen so that user can complete remaining activities.

EM 200
6-94 User Interface

6.3.6.1 Sample Tray


When you click on the Status Monitor, by default SAMPLE TRAY screen is displayed.

The SAMPLE TRAY screen gives a graphical representation of the occupied samples positions on
the sample tray assembly. The tube positions are color-coded so that you can easily check the
status of the samples when they are scheduled for batch run.

6.3.6.1.1 Sample Status Indicators

When the batch run is started, each samples will go through number of states will be represented in
the following color codes:

Color Code Status Description


When a sample position has scheduled test(s) then the circle with
Scheduled
respective sample position is indicated with TURQUOISE COLOR.
For a sample position, when sampling for test has been completed but the
In Process measurement is in progress and results are yet to be reported, then the
circle is indicated with YELLOW COLOR.
For a sample position, when one or more test(s) are pending due to
Sample/Reagent/Diluent absent or occurrence of VOD error; then the circle
Pending
is indicated with ROSE COLOR. Pending test(s) on such sample positions
can be re-scheduled either during run or at the start of the run.
When results of all the tests scheduled for a sample have been reported
Completed and no test results are pending, then the circle is indicated with GREEN
COLOR.

Sample tray also shows the current RCT and RGT temperature in the top right position on the
screen. If the RCT and RGT temperature is within range as specified System Parameters, the

EM 200
User Interface 6-95

temperature is highlighted in green background color. When the temperature falls out of the range,
then it is highlighted in red color background.

6.3.6.2 Reagent Tray


When you click on the Reagent Tray, the following screen is displayed.

The Reagent Tray will displays the the updated volume present inside the bottles, after reagent
barcode scan and reagent level scan during run. Also, you can scan the volume of reagent bottles
manually, and view the updated details in this screen. Use Volume Scan button to scan the reagent
bottles.

If you place the pointer over any of the bottle, it displays the Consumable Name, Bottle Type,
available volume in ml, Reagent Name and the number of possible tests can be performed using #
sign (only when run is not in progress).

After the reagent barcode scan and reagent level scan the status will be represented in the following
color codes:

Color
Status Description
Code
If the level in the reagent bottle is defined, then it is indicated with BLUE
Normal
COLOR.
If the level in the reagent bottle is below threshold level i.e. a specific % of the
Low bottle capacity, then it is indicated with YELLOW COLOR. You can define your
own threshold level for reagent bottle in System Parameters screen. See

EM 200
6-96 User Interface

section System Parameters for more details.

Empty If the reagent bottle is empty, then it is indicated with WHITE COLOR.
If the reagent position is free (reagent not defined), then it is indicated with
Vacant
GRAY COLOR.
Discard If the reagent position is discarded, then it is indicated with DARK ORANGE
ed COLOR
If the reagent at a particular position has crossed expiry date, then it is
Expired
indicated with RED COLOR.

Color codes used for showing the bottle caps:

Color Code Description


If the diluent is assigned at a position on the reagent tray, then the it is indicated with
CYAN COLOR (Bluish shade of green).
If wash solution is assigned at a position on the reagent tray, then it is indicated with
BLUE COLOR.
If reagent is assigned at a position on the reagent tray, then it is indicated with
BROWN COLOR

6.3.6.2.1 Volume Scan

This button is used for scanning the reagent volume before scheduling a run. On clicking this button,
the probes move to all positions in the reagent tray and the reagent level status is updated and
displayed on the REAGENT TRAY screen.

Volume Scan button will scan all the reagent bottles present on both tray (before scheduling a run).
On clicking this button, the probes move to all positions in the reagent tray and the status will be
displayed graphically on the Reagent Tray screen.

After reagent scan, reagent volume details will be updated in Reagent Position screen.

You can use Stop to stop the volume scan.

6.3.6.3 Reaction Curve


Reaction Curve option is used to monitor the online reaction curve of a test, during run.

To do this, click Reaction Curve button and double click on a required test in the Cycle Map grid in
the right-most corner of the screen. On clicking, the Reaction Curve (till “x” cycles) will be displayed.
The pink arrow indicates the measurement points used for calculating the result.

EM 200
User Interface 6-97

When the run is completed, the final tests result will be displayed in the result grid that is located on
the right bottom corner of the screen. The final reaction curve will be generated and can be viewed in
Reports > Reaction Curve screen. To view the curve number for the particular test, double click on
the result. On clicking, a small test details box will be displayed, which contains all the information
about the test with curve number.

6.3.6.4 Barcode Scan


Using this button, barcoded sample and reagent bottles can be scanned.

Barcode scan of the samples and reagents is performed prior to start of the run, if the option
Reagent and Sample is selected from the Pre-run Options.

The Barcode Scan button will be disabled if the option Barcode Reader option
is unchecked from the System Parameters screen.

To scan the barcode, click on the appropriate button:

Sample Barcode Scan

Using this button, you can scan the barcoded sample bottles placed on the sample tray (offline).

When you click on Sample Barcode Scan button, all the barcoded sample tubes placed on the
sample tray will be scanned and the details will be updated on the screen.

EM 200
6-98 User Interface

During this process, the sample tray will be scanned for barcoded samples. After scan is over, the
sample details (like Sample ID and Position) will be updated and displayed in the following
screens:

Patient Entry

Status Monitor > SAMPLE TRAY

Status Monitor > Barcode Scan

On completing sample barcode scan, the tests scheduled on the LIS will be automatically
downloaded and applied to the appropriate samples if the communication between analyzer and
Host computer is ON.

Barcode scan of the samples will be performed prior to start of the run, if the option Sample is
selected from the PRE-RUN OPT.

The Sample Barcode Scan button will be disabled if the option Sample
Barcode is unchecked in Settings > System Parameters screen.

This option will be disabled in closed system.

Sample tubes are always scanned for barcode.

Reagent Barcode Scan

EM 200
User Interface 6-99

Using this button, you can scan the barcoded reagent bottles placed on the reagent tray.

When you click Reagent Barcode Scan button, all the barcoded reagent bottles placed on the
reagent tray will be scanned and the details will be updated on the screen. Details like reagent
name, lot number, expiry date, and reagent position number.

To perform reagent bottles scan, place the reagent bottles on the tray,and click Reagent
Barcode Scan button.

After the scan, the available reagents on the selected tray number will be scanned and the
barcode id will be displayed on the screen. Reagent bottles which are not registered by Scan
Pack , then respective reagent bottle position will be displayed with barcode number along with
unknown pack details as shown in below screen See the following figure.

After Reagent Barcode Scan, Reagent Position marked with Transfer to Tube will be retained
across the batch till user either manually modifies the position or scans bar-coded Reagent bottle
on that position.
In case, barcoded Bottle is scanned on position marked as Transfer to Tube then consider
barcoded Reagent Bottle on the respective position

Column S.N. represents the Position number in the Tray.

Column Reagent Barcode generally shows the barcode number read from bottle.

In some cases, instead of barcode number, following content may be displayed in this
column.

“Checksum Mismatch”: When the checksum digit does not match the calculated
checksum of the bar-code digits.

EM 200
6-100 User Interface

“Unknown-barcode”: When the digits read are not as per required format or less than
18 digits are read.

“RGT Code Unknown“: When the Reagent Code is not found in the list of Reagents in
Consumables screen.

“-“: Reagent position is manually defined through Utility > Reagent Position screen.

Reagent(s), their position, Lot number and Expiry date is registered in the system for the
barcoded bottles.

Expiry date is not applicable for barcoded system solutions (for


diluents and wash). They are treated as system solution without
expiry.

Reagent is identified from the Reagent code mentioned in the barcode pattern and matching
this Reagent Code with the Reagent Code mentioned in the list of reagents in the
Consumables screen.

This updated information is available in the Utility > Reagent Position screen.

Lot number is added in the list of Reagent Lots in Consumables screen.

The Reagent Barcode Scan button will be disabled if the option Reagent
Barcode is unchecked in Settings > System Parameters screen.

Reagent barcode scan is mandatory in closed system, however, if the


Reagent Barcode option is de-selected (un-ticked) from the Settings >
System Parameters screen, then user can proceed with earlier scanned
barcoded reagent bottles.

This option will be disabled in closed system. Reagent bottles are always
scanned for barcode.

Re Scan
On using this option, the system application will prompt user for a re-scan of unidentified / unread
barcode at empty positions on the reagent tray.

Re Scan process is carried out only after the default barcode scan is completed.

User can choose to re-scan barcode or he may skip and continue with further activities.

6.3.6.5 Pre-Run Options


Pre-run Options is available on the Status Monitor. All option under this will be performed when the
run is started. The Pre-Run options selected by the user is memorized and displayed as selection,
which can further be changed. The following options are available.

EM 200
User Interface 6-101

See the following pre-run options in more details:

Auto Rerun

This option is used for automatic re-sending of patient samples on flags. When this option is
selected, patient samples after sample processing will be automatically re-sent for the sample
run; in case the results are with specific flags.

Automatic Rerun of patient sample is performed if:

Auto Rerun option for that test is selected in Test Details screen.

Prozone Limits, Technical Limits, Panic Limits and Reaction Absorbance Limit should be
checked in Test Details screen for the respective test.

Flags selected in Rerun Flags screen for which rerun schedule has to be sent.

Disk Change

This option is used if you want to change the current Sample Disk (or Sample tray, defined as
Group in Patient Entry screen) with the new disk during the same batch run.

On completion of sampling from the current Sample disc in progress, the message will be
displayed for loading the new sample disc, as follows.

Remove the current sample disc and load the new sample disc.

To proceed with the sampling from newly loaded sample disc and continue batch run.

a. Select the appropriate group number from the SELECT DISK NO drop-down list. This group

EM 200
6-102 User Interface

number represents the group of samples loaded on the newly replaced sample disc.

b. Use SAMPLE BARCODE SCAN option to scan the (newly installed) sample disk, before
proceeding with the sampling.

c. Click LOADED to proceed with run.

Auto-Rerun of patient samples will not be performed if Disk Change option


is selected.

Auto Resch (auto reschedule)

When this option is selected, any tests which are moved into pending list (due to reagent absent/
VOD) will be automatically rescheduled if the corresponding reagents are available on the reagent
tray.

If the corresponding reagent is not available on the tray, you need to load non-barcoded Reagent
Bottles as follows.

Keep the reagent bottle on the tray first and then click Refresh Position button, select position(s)
where you have kept the reagent bottles and then click on OK button. Refer section Refresh
Positions during run for more details.

For loading Barcoded Reagent Bottles, refer Add Sample and Reagent (Barcoded) for details.

Auto reschedule of pending tests will be performed only after completing


the existing schedule.

Test will not be auto rescheduled when sample is not available in Sample
Tray i.e. either Sample absent / VOD is reported or position is cleared.

On the Refresh Position screen, note ‘Pending Test Will be Auto


Rescheduled’ will be displayed on if Auto Resch option in Status Monitor
is selected.

Barcode Scan

On checking this option, all samples and reagents that are placed on the Sample Tray and
Reagent Tray will be scanned for barcode before starting the run. Two options are available:

EM 200
User Interface 6-103

Reagent

On checking this option, the barcoded reagents (R1, R2) that are placed on Reagent Tray will
be scanned for the barcode. After scan is over the reagent details (like Reagent name, lot
number, expiry date, and reagent position number) will be updated and displayed in the
following screens.

Status Monitor > REAGENT TRAY

Status Monitor > BARCODE SCAN

Utility > Reagent Position

This option is mandatory and its deselection will be disabled in closed


system.

Reagent bottles are always scanned for barcode in closed system.

Sample

On checking this option, all samples that are placed on the Sample Tray will be scanned for
the barcode. After scan is over, the sample details (Sample ID and Position) will be updated
and displayed in the following screens:

Status Monitor > SAMPLE TRAY

Status Monitor > BARCODE SCAN

Patient Entry

When the Host communication (between analyzer PC and Host computer) is ON; on
completing sample barcode scan, the tests that are schedule on the LIS will be automatically
downloaded and applied to the appropriate samples.

The sample tray will be scanned during Sample Barcode scan and the Sample ID and Position
number will be updated in the Patient Entry screen. The application will then query LIS for the
details of these barcoded Sample ID. Patient demographic and the Test schedules are
downloaded from LIS and can be viewed in Patient Entry screen. The tests scheduled for the
samples will be performed on the analyzer and results will be sent back to LIS.

Reagent Level Scan

This option is used for scanning the volume of the reagent present inside the reagent bottles
before starting the run. It is available in the Status monitor > PRE-RUN OPT.

If the option is checked before the run, then when the run starts, all the reagents positions will be
scanned for reagent volume and the status will displayed on REAGENT TRAY screen and Utility
> Reagent Position screen.

Two options are available for scanning:

Selective

Selective: This option is used for scanning the Reagent volume for only those reagents,
which are defined and required by the samples in current batch. When you click on

EM 200
6-104 User Interface

button, the following screen will be displayed.

In this window, by default, the reagents for the scheduled tests and all consumables
loaded in that batch run will be displayed as selected. See figure above. If user modified
the selection, then those selections will be memorized and displayed next time.

: On clicking this button, the user modified selections will be


automatically cleared and only those reagents which are scheduled for that batch run will
be displayed.

The Diluents & Wash solution positions are always scanned, if defined. It
will not be displayed for selection.

If no tests are selected then MultiXL will only scan volume at positions
where Wash solutions, Serum Diluents and Urine ISE Diluents are
defined.
After the volume scan, if the volume of wash solution and/or diluents in
the reagent bottles is less than 10 ml, then the low volume message will
be displayed in the error message grid of Status Monitor. For example.

"Special diluent is Low(Less than 10ml)”


"Wash solution is Low(Less than 10ml)”

In case of ISE tests, if ISE urine diluent is less than 10 ml, then it will
displays the following message “ISE Urine Diluent Low (Less Than 10
ml)”with the following options:

Click on Yes button to proceed with batch Run with ISE


Click on No button to proceed with batch Run without ISE
Click on Cancel button to stop the batch Run

All

All: This option is used to scan all the reagents available on the tray.

When you select this option, button for selective scan will be disabled.

EM 200
User Interface 6-105

If Reagent Absent, VOD or Liquid Level found different, errors are displayed
during pre-run activities then the corresponding reagent position is added to
the Refresh Positions screen. In this case user is advised to observe bottle
physically and take required corrective actions and then refresh the
positions manually to use that particular reagent bottle.

6.3.6.6 Run Options


Run Options is available on the Status Monitor. Make sure that respective run options are selected
before start of the run.

See the available run options in the following figure.

6.3.6.7 Work List


When insufficient volume details or incomplete test details are detected, during pre-run operations,
the work list screen may be displayed and the run is halted.

Work List screen displays the sample and reagent details for the scheduled run. Work List screen
will be displayed if:

Reagents are absent for the programmed tests

The defined diluents are not present

Volume is insufficient for the programmed tests

When user clicks Work List button on Status Monitor

EM 200
6-106 User Interface

The work list screen is divided into two sections.

Schedules in Work List

This section will displays the information about Sample Position, Sample ID with Container
type, Sample Volume Required, Sample Type, Test, Sample Volume, R1 Volume Defined, R2
Volume Defined (optional), Number of Reagents, R1 Position Available, R1 Volume Available,
R2 Position (optional) Available, R2 Volume Available (optional).

Test(s) in work list will be highlighted in red background, in case parameters (such as Sample
Volume, R1/R2 reagent positions, Reagent Volume defined etc) are not defined completely. In
such case, a message “Incomplete Test Details” will be displayed above the grid.

Reagent Volume Details

This section will display the information about reagent volume. Information such as RGT Type,
RGT Position, RGT Volume Available, Possible Test(s), Scheduled Test(s), RGT Volume
required.

If reagent volume available in the bottles is less than the reagent volume required for the total
number of possible tests then the column RGT Volume Available and RGT Volume Required is
highlighted with yellow background and a message “Reagent Volume Insufficient” will be
displayed above the volume grid.

Also, it will display the total number of possible tests (approximate) with the available reagent
volume.

Open count

Analyzer accumulates open-channel Test-counts as obtained by scanning of each Reagent


pack Kit.

EM 200
User Interface 6-107

Analyzer performs open channel tests, not exceeding total permitted Test-count & reduces test
count based on test(s) performed on the analyzer.

It will also intimate user during run if Open Count reaches 10 & below.

Following buttons available on the Work List screen:

PROCEED

If the tests details for all the tests are proper i.e. without any tests having background as red,
when this button is clicked, run will be started else run will not start.

CANCEL

Use this button to abort the run. However, clicking CANCEL during run will only close the screen.

Pending And Masked Test List

This button will be highlighted in red color if any test is masked due to incomplete test details or
when one or more test(s) are pending due to Sample/Reagent/Diluent/Special Diluent absent or
occurrence of VOD error.

To reschedule the pending tests, the corresponding tests should be selected and clicked on RE-
SCHEDULE button. Alternatively, the tests can be selected from the Test list, select Pending
option and click on RE-SCHEDULE button.

To reschedule the masked tests, the corresponding tests should be selected and clicked on RE-
SCHEDULE button. Alternatively, the tests can be selected from the Test list, select Mask option
and click on RE-SCHEDULE button. Click on CLOSE to close the screen.

Test(s) on Hold

Using this button, you can keep the specific test(s) on hold by masking them in work-list. User-
selected test(s) will be masked in the existing work-list as well as the new test order received
later, either through LIS or scheduled manually by user. On clicking, a test selection window

EM 200
6-108 User Interface

containing all the test(s) will displayed as follows.

User can keep one or multiple tests on hold by selecting the check box, as per your requirement.
Once tests are selected, click on OK button to save the selections.

When the tests are selected during run, further tests will be masked. But
when the tests are selected before starting the run, then all scheduled
tests will be masked.

User can re-schedule the masked test(s) for all or selected samples, from
Status Monitor > Work List, even if the test(s) selected are on Hold.

Re-scheduling the Test(s) from the Work List will not automatically remove
the On-Hold status of the Tests.

Therefore, it needs to be done manually by un-ticking the tests from the


Test(s) on Hold window.

6.3.6.8 Add Sample and Reagent (Barcoded)


Additional samples and reagents can be loaded on the trays using Status Monitor screen during run.
If you want to add a new bar-coded sample or reagent (continuous sample loading), the following
procedure should be used:

Adding Barcoded Reagent

lf the user wants to add a new barcoded reagent (Continuous Reagent Loading), the following
procedure should be used:

1. The user clicks on the Add Reagent button.

2. After the button is clicked, the message “Please Wait R1 Dispense Is In Process”.
Sampling will pause after the completion of Reagent 1 dispensing of the current test in
process.

3. After the button is clicked, the message “Please Wait R2 Dispense Is In Process”.
Sampling will pause after the completion of Reagent 2 dispensing. If no R2 is available,
then this message is not displayed.

4. Once the message disappears, a following message appears to open dome and add
reagent;

EM 200
User Interface 6-109

5. Now user can open the dome and place new reagent bottles.

6. Once the user is done with adding reagent, he can click on Added.

7. Closed Dome to proceed message will be popped to close dome. User should close the
dome to proceed run. Reagent barcode scan will starts with message displayed as
“Please Wait Reagent Barcode Scan In Process”..

8. After the completion of reagent barcode scan, the reagent positions along with the barcode
details of the new test are updated.

9. The user can view the scanned reagent barcode data by clicking on the Barcode Scan
button.

10.The user can view the scanned reagent barcode data in Utility > Reagent Positions
screen.

11.While scanning, earlier barcoded reagent positions are cleared when the reagent barcode
is not found on the same.

On Add Reagent During RUN ,if Wash and Diluent position is not found
after Reagent Barcode Scan (i.e.user kept barcoded reagent bottle on
Diluent / Wash position), then either Pause further Sampling of that
batch with appropriate message OR mark associate Test(s) as
masked / pending and proceed with work list as applicable.

EM 200
6-110 User Interface

Adding Barcoded Sample

If the user wants to add a new barcoded sample (Continuous Sample Loading), the following
procedure should be used:

1. Click on the Add Sample button in Status Monitor screen.

The Add Sample button is available only when Sample Barcode


option is ticked (set ON) from Settings > System Parameters screen

Message Please Wait Sampling Is Being Paused is displayed. Sampling will be


paused after completing the current test in process.

2. Following message appears to open dome and add samples;

3. Now user can open the dome and place new sample tubes in the sample tray.

4. Once the user is done with adding samples, he can click on Added.

5. Closed Dome to proceed message will be pooped to close dome. User should be close
the dome to proceed run. Sample Barcode scan starts with message displayed as Please
Wait Sample Barcode Scan In Process. On completion of the sample barcode scan,
each Sample ID, if not found in Patient Entry screen is added and the positions of new
samples get updated in the Patient Entry screen.

6. Sampling continue after updation.

7. The user can see the scanned data by clicking Barcode Scan button on the same screen.

Manual Pause

During Run if user Click on (pause), Message Please Wait Sampling Is Being Paused is
displayed. Sampling will be paused after completing the current test in process. Following
message will be appeared to open dome.

Now user can add samples / reagent > Close dome > Click on Resume to continue RUN.

EM 200
User Interface 6-111

When user opens dome immediately after clicking on Pause / Add


samples / Add reagent (before sampling is paused) then ARM movement
will be stopped immediately and error message will be displayed in
error display grid.

6.3.6.9 ISE Pack


ISE pack button is used to check the ISE pack details.

This button is visible only when the option ISE Module is checked in System
Parameters.

These details are viewable only before starting the run as this option is disabled during the run.

On clicking this button, the ISE reagent pack information will be displayed which contains.

Lot Number, Installation Date and Expiry Date of current ISE Reagent Pack

Details of all ISE Calibration values

Remaining ISE Reagent Volume Indicator (approximate remaining volume of Calibrant A and
Calibrant B; whichever is lesser).

The system detects New / Change in ISE Reagent Pack only on interacting with
ISE module (by clicking ISE ON from the Maintenance screen or on starting the
ISE run) or during Auto Maintenance operations. Hence, if the user clicks ISE

EM 200
6-112 User Interface

Details button just after (physically) installing the New ISE Reagent Pack,
system will displays the ISE Details of the earlier Reagent Pack.

On detecting (and registering) new ISE Reagent Pack, Backup of ISE inventory
data of earlier Reagent Pack will be taken by the system on the analyzer PC.

During ISE Sampling (Serum/Urine Samples), ISE inventory is updated even on


the occurrence of Time Out/Error received in ISE result string from analyzer.

6.3.6.10 Refresh Position


During run, if any of the reagents or diluents is absent then the position will be indicated as position
with empty bottle and will not be used during run, till you refresh the reagent position.

Hence, if the user wants to use that position, use Add Reagent. On clicking, sampling will be
paused, then open the Reagent cover. Then, put new reagent bottle at reagent absent position, close
the RGT cover. Make sure that 'RGT cover open ' message has disappeared. Then click on Refresh
Positions button either from Utility > Reagent Position screen or Status Monitor > Reagent Tray
screen.

1. On clicking Refresh Positions button, the following screen will be displayed.

2. This screen would display only those reagent positions which had an empty bottle (no volume)
at that position. If there are no empty bottles on the reagent tray then Refresh Positions
button would be disabled.

3. In the above screen, select the position at which filled reagent bottle is placed and hence
needs to be refreshed. Then, click on OK to refresh the position.

4. Click on All to select all positions at once and click on None to deselect.

5. Click on CANCEL to close the screen.

6.3.6.11 Scan Pack

Scan Pack option remains enabled only in Test Loader System.

EM 200
User Interface 6-113

Scan pack option is used to scan the details of System Pack Reagent kits for Closed channel
reagents.

On selecting this option reagent pack details will be displayed which contains Reagent name, Lot
number, Expiry date, Manufacturing date and number of reagent bottles with volume.

Click Status Monitor > Scan Pack > System Pack Details > Scan pack > following details will
get displayed.

Click Register , system pack will get registered and messages will be displayed as "XL System
pack registered successfully" as shown below

When user scans the system pack from Scan Pack and if scanned Reagent code is not defined in
Consumables then following message will be displayed as " RGT Code Unknown " that means that
system pack is not registered by system.

EM 200
6-114 User Interface

To scan the Special Card, Click Status Monitor > Scan Pack > System Pack Details > Scan
pack > following details will get displayed;

Click Register, card details will get registered and messages will be displayed as "XL System pack
registered successfully" as shown below

EM 200
User Interface 6-115

Open channel tests can also be loaded using special cards which may be
available for purchase from manufacture in special circumstances.

6.3.6.12 Online Calibration


During batch run, when the new reagent bottle is detected after barcode scan, the system will ask for
the calibration for newly detected reagent bottles. It happen only when option Online Calibration is
checked for that test. This option is available in Test Parameter > Test Details screen and should be
defined before the run.

Setting online calibration for a test:

1. Go to Test Parameter > Test Details screen.

2. Select the appropriate test for which the online calibration is required.

3. Check the Online Calibration option, and click SAVE.

Use SET ONLINE CALIBRATION option, if you want to select multiple tests.

Online calibration process:

EM 200
6-116 User Interface

When the batch run is started, the system will perform the following operations.

1. Reagent barcode scan (if selected from PRE-RUN OPT).

2. Sample barcode scan (if selected from PRE-RUN OPT).

3. Reagent level scan (mandatory, if Online Calibration option is selected for at least 1
test. Otherwise, volume scan is performed, only if selected from PRE-RUN OPT).

4. During batch run, when the reagent is found absent or bottle is changed, the Calibration
Required button will blink on the screen. See figure shown below

. Blinking of this button will be stopped in any of following conditions:


.
Till it is clicked for calibration or test run completed.

If Emergency Stop button is pressed from the Service Check screen

5. Clicking on this button, Calibration Check screen is opened. This screen contains the
list of reagents for which new reagent bottle is detected and calibration is required.

EM 200
User Interface 6-117

. This screen will show the test(s) for which new reagent bottle is detected and
requires calibration. When the calibration prompt is displayed on the start of the
run, the following options will be available.
.
Proceed using current calibration

Mask above test and proceed

Do not proceed with run

. The system will function as follows on selecting any of the above options.

If the user selects Proceed using current calibration, then the system will
continue with the run. The test(s) in the above list will be performed as part of the
work list. The result (of the tests for which calibration prompt is displayed) will be
calculated with the available calibration. Such results will be flagged as Cal**.

If Mask Above (Scheduled) Test and Proceed is selected then the Test(s) in the
list will be masked. Run will continue with other scheduled Tests in the work list.

If the user selects Do not proceed with run then run will not start. User may take
necessary action (schedule calibration) and start the run again.

6. Perform Auto-span.

7. When the above requirements are performed, the run will continue.

Procedure to schedule the masked Test(s) during run

Perform the following steps to re-schedule the masked test(s) during run.

1. Click Add reagent to load the reagents on Reagent Tray and load calibrators on Sample
Tray; if not available on board.

2. Schedule Calibration for the test from Calibration > Schedule QC / Calib screen.

EM 200
6-118 User Interface

3. Un-mask the Test (patient and control) from the work list.

4. System will first perform calibration with the Reagent bottle. Control & Patient results will
be declared with the new calibration (if successful).

To calibrate new reagent bottle during run: User should load calibrator(s) on
Sample Tray before scheduling the calibration. On failing to load calibrators,
analyzer will encounter calibrator absent and calibration will be considered
as unsuccessful / failed. In such case, results will be calculated using earlier
successful calibration and declared with Cal* flag.

Reagent Absent During Run

During run, when reagent is found absent then:

1. The Calibration Required button on Status Monitor will blink till it is clicked or run is
completed. On clicking Calibration Required button, a new window will open showing the
List of Reagent(s) that requires calibration.

2. Remaining Test schedules are added in Pending List.

3. System will not switch over to next Reagent position even if multiple reagent positions are
defined / available.

4. User can load reagent and calibrators, schedule calibration and re-schedule patient and
control schedules from Pending List by clicking Work List button on Status Monitor. In
such case, calibration will be performed first. Patient and control results will be declared
using the new calibration.

5. Alternatively, user can re-schedule the test from Pending List without programming
calibration. In such case, result will be calculated using the current (available) successful
calibration and declared with Cal** flag.

EM 200
User Interface 6-119

Pre-requisite

Reagent bottle, once placed on a position is not removed or swapped with the other
position.

Reagent Bottle taken off from Reagent tray and placed with barcoded
reagent during Add Reagent operation will be detected as new bottle
and will prompt for calibration.

User will be able to schedule calibration during run provided the positions are free in
Sample Tray. Consumables (with Lot details) required for calibration are defined and
available.

Calibrator(s) (multiple calibrators in case of non-linear parameters) are made available on


board in the Sample Tray for calibration during run.

User will select Online calibration for the test(s) for which tracing Reagent Bottle
change-over is required.

Non-barcoded Reagent Bottle is replaced with another reagent bottle having same
reagent of the same volume as that of the earlier bottle; cannot be detected as new
bottle.

Recommendation: Select Online Calibration option for the test just before the batch
when calibration of the test is scheduled. Then onwards, system can easily trace the
bottle change. On selecting the option, system will prompt for calibration, ignoring which
results will be declared with Cal** flag.

Recommendation: While placing multiple Reagent Bottles on the Reagent Tray, place
calibrated bottle on the lower position and new un-calibrated reagent bottle on the higher
position in the Reagent Tray.

6.3.7 Search
Search is used to search Consumables, Test Parameters, Patient Information, Sample Information
and Result. The following screen will be displayed.

EM 200
6-120 User Interface

See the following section in more details:

Patient/Sample

Patient Results

Calib/Control Results

Consumables

Tests

6.3.7.1 Patient/Samples
Patient/Samples screen is used to search the patient and sample information.

EM 200
User Interface 6-121

Enter any one or more parameters to search the required output:

Parameters Description
Patient Name Enter the patient name.
Patient ID Enter the patient ID.
Doctor Select the patient's doctor name.
Sample ID Enter the sample ID.
Sample Type Select the sample type from the list.
Collection Date Enter the date range on which the sample is collected.
Reg. Date Enter the date range on which the registration is done.

Use two or more combination from above parameters to make advance search.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. In the search result, you can able to see the name of the operator and the modified date in
Operator ID and Modified On column.

The above selection can be cleared using Reset button.

6.3.7.2 Patient Results


Patient Results screen is used to search the patient results.

EM 200
6-122 User Interface

Enter any one or more parameters to search the required output:

Parameters Description
Patient Name Enter the patient name.
Patient ID Enter the patient ID.
Doctor Select the patient's doctor name.
Flag Select the required flag from the list.
Test Select the required test from the list.
Sample Type Select the sample type from the list.
Sample ID Enter the sample ID.
Result Date Enter the date range.

Use two or more combination from above parameters to make advance search.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. Result Date column will displays results date along with time.

The above selection can be cleared using Reset button.

6.3.7.3 Calib/Control Results


Calib/Control Results screen is used to search the calibration and control results.

EM 200
User Interface 6-123

Select the required consumable type and then enter any one or more parameters to search
the required output:

Parameters Description
Lot No. Enter the consumable lot number.
Test Select the name of test from the list.
Flag Select the name of flag from the list.
Enter the date range.
Result Date From
During run, the date difference to view the records should be 30 day.
Result Date To

There is a choice of searching the entire consumables or selecting one consumable at a time.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. Result Date column will displays results date along with time.

The above selection can be cleared using Reset button.

6.3.7.4 Consumables
Consumable screen is used to search the consumable information.

EM 200
6-124 User Interface

Select the required consumable type and then enter any one or more parameters to search
the required output:

Parameters Description
Manufacturer Select the list of manufacturer from the list.
Enter the expiry date range.

Expiry Date This is not applicable to Blanks, Diluent or Wash Solution.

Lot No. Enter the lot number.


Whole word Select any one search option, as appropriate.
Match

After providing necessary inputs, press Search button.

The above selection can be cleared using Reset button.

6.3.7.5 Tests
Test screen is used to search the tests parameter details according to the specified inputs.

EM 200
User Interface 6-125

Enter any one or more parameters to search the required output:

Parameters Description
Primary Wavelength Select the required primary wavelength.
Secondary Wavelength Select the required secondary wavelength.
Assay Type Select the assay type
Curve Type Select the curve type.
Reaction Direction Select the appropriate reaction direction from the available options.

After providing necessary inputs, press Search button.

The above selection can be cleared using Reset button.

6.3.8 Reports
Reports is used to view the patient reports, error log details, reaction curve, reagent consumption,
ISE calibration, sample information, patient results, consumables, test parameters, calibration
results and control results etc.

EM 200
6-126 User Interface

See the following screen for more details:

Patient Reports

Result Reprint

Test Statistics

Calibration Trace

Calibration Monitor

Error Log

Reaction Curve

Other

6.3.8.1 Patient Reports


Patient Reports screen is used for viewing and printing the patient reports. The reports can be view
as per the following search criteria:

Patient Name wise

Sample ID wise

Test wise

Doctor wise

EM 200
User Interface 6-127

Patient ID wise

See the following screen.

See also:

Parameters to display records are per required selections.

Parameters Description
From and To This option is used to select the date range.
If the user selects Location, then Patient Reports related to that Location
Location can be viewed depending on the From and To date selected. Click on
SHOW to display the selected reports.
It is possible to search the patient results batch wise. Patient Records are
Batch displayed depending on the batch number selected. Click on SHOW to
display the selected reports.
Select the sample ID by entering initial characters of the sample ID, and
then click on SHOW to display the selected report. This will displays the
Sample ID
patient report related to that sample ID, depending on the From and To date
selected.
Select the patient ID by entering initial characters of the patient ID, and
then click on SHOW to display the selected report. This will displays the
Patient ID
patient report related to that patient ID, depending on the From and To date
selected.

Select the doctor from the list. Click on SHOW to display the report. This
Doctor Name
will displays the patient reports related to that Doctor, depending on the

EM 200
6-128 User Interface

From and To date selected.


Select the required test by clicking on three dotted button. After test
Test selection, click on SHOW to display the report. This will displays the
patient reports depending on the From and To date selected.
Select the patient name by entering initial characters of the patient name,
and then click on SHOW to display the selected report. This will displays
Patient Name
the patient report related to that sample ID, depending on the From and To
date selected.

Select any one relevant option to display the results

Photometric Tests: If the user selects this option, then only photometric test results are
displayed. By default, this option is selected.

Calculated Items: If the user selects this option, then only calculation item results are
displayed.

Offline Results: If the user selects this option, then only Offline Entry results are displayed.

ISE Results: If the user selects this option, then only ISE Results are displayed.

Rerun Results: If the user selects this option, and then only Rerun results are displayed.

Recalculated Results: If the user selects this option, then only Recalculated Results are
displayed.

All: If the user selects this option, then all results (Photometric Test, Offline Results, ISE
Results, Rerun Results) are displayed

Select the Report Options to display the following information on printed reports

The report options will be memorized once the patient report is printed.

These memorized selections are made available as default selection for


subsequent use of the Patient Report screen, which can further be changed
by the user, as required.

Using the reports options, you can customize the generated report outputs.

Print Lab Details: This option is used when the user needs to print the Lab details. Refer
section System Parameters for entering the lab details.
If the user has clicked on the Print Lab Details check box, then the Laboratory details are also
printed in reports.

Hide flags: This option is used when the user wants to print the Reports without printing the

EM 200
User Interface 6-129

associated flags. If this option is selected, the column Flag will not be displayed in the printed
patient report.

In the printed report, the up and down arrow will be displayed if H and L
flag is attached with sample result.

The up and down arrow with H and L flag will be displayed even if the
option Hide Flags is selected in the Report Options in Reports > Patient
Report screen.
N! Flag will be applied for patient results when final result displayed is
negative in Patient Report Screen.

Show Location: This option is used when the user wants to print the Reports with or without
.printing the Location details.

Show Analyst: This option is used when the user wants to print the Reports with or without
printing Analyst details.

Show Sample Remarks: This option is used when the user wants to print the Reports with or
without printing the Sample Remarks.

Show Patient Remarks: This option is used when the user wants to print the Reports with or
without printing the Patient Remarks.

The labels Location, Analyst, Sample and Patient Remarks are not printed on
the report if the user de-selects them in Patient Reports.

Patient report formats

Different patient report formats are available.

Normal

This is a basic report format. The order of printing results of photometric tests, calculated
items and ISE can be set from the Test Sequence screen using PRINT SEQUENCE FOR
PATIENT REPORTS option.

EM 200
6-130 User Interface

Multi Column

This format facilitates to print patient results in two-columnar format, like newspaper. See
figure below.

EM 200
User Interface 6-131

Profile

If the user has selected profiles for scheduling tests from Patient Entry screen, then the user
can print Patient Reports as per the various Profiles selected.

EM 200
6-132 User Interface

Graphical

Patient results and defined reference ranges are graphically represented in this format. Refer to
following figure for example.

EM 200
User Interface 6-133

The patient report’s footer information, top and bottom margin, and signature
will be displayed at the bottom of the report. These settings can be configured
through Settings > System Parameters screen.

Buttons available on the screen

If the regional language is selected other than English from Settings > System
Parameters, then the data displayed under column Category and Sample
Type will be in the selected regional language in the printed patient report.

PRINT: Click this button to print the report.

PREVIEW: Click this button to view patient results that are selected for printing; before actually
printing them.

The report options will be memorized once the patient report is printed.
These memorized selections are made available as default selection for
subsequent use of the Patient Report screen, which can further be changed
by the user, as required.

Online Patient Report printing will also use these memorized options.

The following options are available for selection.

EM 200
6-134 User Interface

Abnormal Results: If the user selects this option, then Results with flag are displayed.

Undo Selection: This option is used to clear the previous selection.

6.3.8.2 Result Reprint


Result Reprint screen is used to retrieve and print the results date wise or for the last batch.

After selecting the required parameters, click SHOW to display the results.

See the following screen.

See also:

Parameters to display results in date wise or batch wise

Parameters Description
Last Batch Select this option to display the results of the latest batch.
Select this option to display results for a specific date or range of dates.
Then select the From and To dates from the calendar drop-down list.
Date wise During run, maximum 7 days data will be displayed for
patients and maximum 30 days data will be displayed for
controls and calibration.

Search results by selecting the following parameters

Parameters Description

EM 200
User Interface 6-135

Select appropriate option to view the details.


Patient or
Controls or During run, patient results of maximum 7 days at a time will
Calibrations be displayed, whereas Calibration and Control results of
maximum 30 days at a time will be displayed.
Select this option to display results for a specific date or range of dates.
Date wise
Then select the From and To dates from the drop-down calendar.
Patient Name Select the patient name by entering initial characters of the patient name.
Patient ID Select the patient ID by entering initial characters of the patient ID.
This will displays all the patient records of all dates which are present in the
Any Date
database.

Print patient name, ID and lab details on printed reports

Parameters Description
If you want to print the lab details on the printed patient report, check this
Print Lab Details
option and then click on Print button.
On checking this option, the additional column Patient ID and Patient Name
Print Pat ID,
column will be displayed on the print report in the landscape orientation. If
Name
this option is not selected, the report will be generated in portrait orientation.

Command buttons

Parameters Description
This button is used for sending the selected results to the LIS, after batch
run is completed.
This button is visible only if the Host Connection in System
Parameter screen is checked.

While sending the results to LIS during run, if the connection


Send to Host
between LIS and Analyzer is disconnected, a message will
be displayed “LIS Connection is not Responding” in Status
Monitor.

For any test containing "µ" in unit, "µ" gets transmitted as "u"
to LIS.
Print This button is used for printing the Results on printer or PDF writer.
Export This button is used for export the Results on an excel sheet.
Use this button to invert the selection that is made. Clicking on this button
Inv. Selection
will select the unselected items and vice verse.
Select All Use this button to select all the results displayed on screen.

Use the filter data options to filter patient’s results

Parameters Description
Test Displays results as per selected test from list.
Sample ID Displays results as per selected sample ID from list.
Batch Displays results as per batch number selected from list.

EM 200
6-136 User Interface

Total Tests: This field displays the total number of tests performed for the selected criteria

Total Tests count will be refreshed only on click of SHOW button and not on
click of check box of every row in the grid showing data.

Description of each column displyed in the grid

Column Name Description


Sample ID Displays the sample ID of the patient
Patient Name Displays the patient name
Test Displays the test name
Result Displays the test result
Unit Displays the test unit
Flag Displays the flag associated with the test result
Result Date Displays the date on which the test was performed
Curve No. Displays the reaction curve number.

To view the reaction curve, double-click on the Reaction Curve


number in the column “Curve #”. A new window with the curve and
reading points displayed. Click on “Close” button to close this
window and go back to the Result Reprint screen.

This facility is available when the batch run is not in progress.

6.3.8.3 Test Statistics


Test Statistics screen is used to view the test statistical details of batch run. Based on the selection,
results will be displayed.

EM 200
User Interface 6-137

See also:

Parameters for Selection

Parameters Description
Date From Enter the beginning date for the results to be analyzed.
Date To Enter the ending date for the results to be analyzed.
Use this option to view the results batch wise. Batch number will be
Batch
displayed only when date is same.
Select the test name to view its statistics. Results of the selected test
Test which is performed on the analyzer is displayed according to Patients,
Controls or Calibration selection.
Select this option if test statistics for a particular age group is required.
Age
Enter age range and press Filter button to get the result.
Select this option if test statistics for a particular test value is required.
Result
Enter result range and press Filter button to get the result.
In case, the user requires the laboratory details to appear as header on the
Print Lab Details
Test Statistics report, then select this option.
Use this option to view result statistics of specific rows displayed on the
S#
screen. Then enter the range of rows in the Start From and End To.
Use this option to specify patient name/consumable for which you want to
Patient Name obtain the statistics. Then enter first few characters of the patient or
consumable name.

Statistical Details

EM 200
6-138 User Interface

Normal Range: Displays the total number of results that were within the normal range defined in
the Reference Ranges screen.

Above Normal Range: Displays the total number of results that were above the normal range
defined in Reference Ranges screen.

Below Normal Range: Displays the total number of results that were below the normal range
defined in the Reference Ranges screen.

Not defined: Displays the total number of results whose reference ranges were not defined in the
Reference Ranges screen.

Total Tests: Displays the total number of results/absorbance’s available.

N: Displays the total number of tests used for calculating the Mean, SD and %CV for a test.

Mean: Displays the average of the result/absorbance that has been selected (checked).

SD: Displays the Standard Deviation of the result/absorbance that has been selected.

%CV: Displays the %CV (coefficient of variation) of the result/absorbance that have been selected
(tick-marked)

Range: Displays the Range of the results that fall within the selected criteria. It shows the
difference between the minimum and maximum range for the same.

Sr#: Use this button to select the range of results/absorbance’s for which you want to obtain the
statistics. Enter the range in Start From and End To textbox. Once the range is entered, click on
Calc button to obtain the statistics.

Command Buttons

Select All: This button is used to select all the sample records for a test.

Invert Selection: This button is used to clear all the selections.

Print: This button is used for printing the Test Statistics for the selected Test in Report format.

Export: This button is used to export the Test Statistic details into the excel sheet and saved in
location C:\MultiXLLOG\TestStatistics.

Calc: This button is used to recalculate the statistics in the other grid at the left-bottom corner of
the screen; as per the result data displayed in screen (based on the sub-filters, such as Sr#,
applied to the result data).

Reset: This button reset the values entered in the Start From and End To textbox.

During run, maximum 7 days data will be displayed for patients and maximum
30 days data will be displayed for controls and calibration.

6.3.8.4 Calibration Trace


Calibration Trace screen is used for displaying the calibration history of a test along with the
graphical representation of calibration data over one month.

EM 200
User Interface 6-139

See the following figure:

This table describes the description of each parameters:

Parameters Description
It is used for selecting the desired test whose calibration history needs to be
Test Name
viewed.
It is used for selecting the month and the year for the test whose calibration
history needs to be viewed. Once the test and the month selection are done,
the grid displays the different calibration dates and time along with the
Month and Year
absorbance’s for blanks and standards. Also, a graphical representation of the
Blanks and Standards can be viewed.]
Blank: It is used to change the range of blank absorbance.

Blank It is used to change the range of blank absorbance.

It is used to change the range of standard /calibrator absorbance.

Standard/Calibrator Use Reset button to reset the range for blank, standard and calibrator
absorbance to range according to the minimum and maximum absorbance of
the blanks, standards and calibrators.

Use Export button to export the data and graph displayed on screen to an excel sheet.

Use Print button to print the data and graph displayed on screen.

EM 200
6-140 User Interface

6.3.8.5 Calibration Monitor


Calibration Monitor screen is used to view the latest calibration details of all the tests at the same
time.

See the following screen.

Following table displays the description of each column in the grid.

Column Description
Test Test name.
Curve Type Type of Curve assigned for that chemistry.
Type Either Blank or Standard S1,S2…etc.
Consumable Name of the consumable.
Lot# Lot no. of consumable used .
Conc. Concentration of the consumable .
Abs. Absorbance of the Blank/Standard.
Factor Factor value of the standards.
Calib. Exp Calibration Expiry Limit (in Days).
Acceptable Limit Acceptable Limit for New Factor.

Use Export to export the calibration data to desired location.

Use Print to print the calibration data.

EM 200
User Interface 6-141

6.3.8.6 Error Log


Error Log screen is used to display the list of errors that is occurred during machine operation. The
list of errors can be filtered according to the type of operation by selecting option All, Run, Service,
Maintenance and Host. This data is generally useful for service/diagnostic purposes.

1. Select the date range by changing the From and To date.

2. Select the operation (All, Run, Service, Maintenance, or Host operations) during which the
errors occurred.

3. Click on Show button to view all the errors.

4. Use Error Code drop down list is used to filter the records as per requirement.

5. In the grid following are the different fields present:

Date – Date and Time of the occurrence of the error.

Batch No – Batch number during run, in which the error occurred.

Error Code – Displays the error code to identify the type of error occurred.

Description – Description of the error occurred.

Action – Action taken on the error occurrence is displayed in this column.

The column “Action” represents the severity of the error, which is as follows:

Pause-P states that the sampling will be paused on occurrence of such errors

EM 200
6-142 User Interface

during run. User may take corrective action and resume sampling by clicking on
the Resume button from Status Monitor.

Pause-R states that the sampling will be paused on occurrence of such errors
during run. On occurrence of such errors, resume sampling in same batch is not
possible. Once the results of all the tests in progress are declared, the batch run
will stop. When the batch run is completed, user should take corrective action and
then start the run again.

STOP states that the analyzer will stop the batch run immediately on occurrence
of such errors.

Errors having blank Action states that they are warnings.

Error description is displayed along with the date and time.

6. To print the details of the error log, user can click on Print button.

7. Use EXPORT button to save the records in the excel sheet. On clicking, the details will be
automatically copied in the excel sheet and the file is saved in the particular location. The
location will be displayed in the Indication text box.

In Bottle Discarded error message, the first three digits denote the Lot no.
whereas the next four digits denote the Bottle no. of the Reagent Bottle
followed by the Reagent Name (as scanned by the barcode reader).

6.3.8.7 Reaction Curve


Reaction Curve screen can be used to view the reaction course (absorbance vs cycle number) for any
reaction.

The reaction curve can be viewed test wise and sample ID wise for patient results or Test wise and
Consumables wise for Blank, Standard/Calibrator and Control Results.

EM 200
User Interface 6-143

Click on the dotted button near the test text box to select the required test. Click on the dotted
button near the Sample ID text box or consumable text box to select Sample ID or Consumable
respectively.

Use crossed button to clear the respective selection criteria in the adjoining text box, as required.
See the following figure.

Alternatively, one can also search a specific curve number by ticking Search By Reaction Curve
No. check box and then entering the reaction curve number in Curve No. text box (It allows to enter
up to 9 digits). The user has to click on SHOW to view the reaction curve as per selection.

Reaction curve number is a unique serial number assigned by the program during analysis. The
reaction curve number can be obtained from the Result Reprint screen. The absorbance values for
the selected time course are displayed in a tabular format as well as graphically.

M1S, M1E, M2S, M2E and Extended M2E and also Ap, As, Ap-As for a particular chemistry are
shown on the time course. These points can be identified by legends placed below the time course.

R2 addition line is shown with the red arrow.

The time course display also contains the following details regarding that reaction curve.

Result: It displays the result of the test selected.

Flag: It displays the flag associated with the Result.

Primary Wavelength: It displays the primary wavelength to be used for measurement of that test,
as set in the Test Parameter > Test Details screen.

Secondary Wavelength: It displays the secondary wavelength to be used for measurement of that
test, as set in the Test Parameter > Test Details screen.

Assay Type: It displays the Assay Type for that test, as set in the Test Parameter > Test Details
screen.

Average O.D./Delta Abs/min: It displays the Average O.D. for End Point Assays or Delta Abs/min
value for Rate Assays; calculated within the specified time intervals for that test. .

Format: It allows selecting either to display in the graph only Ap (Absorbance at Primary
Wavelength) or only As (Absorbance at Secondary Wavelength) or both Ap and As or Ap-As or All.

An explanation of various columns shown in the table is given below:

Column Name Description

Cycle Absorbance cycle numbers are displayed in this column.

EM 200
6-144 User Interface

Absorbance of the reaction mixture at primary wavelength after


Ap
subtraction of cuvette blank absorbance at primary wavelength.
Absorbance of the reaction mixture at secondary wavelength after
As
subtraction of cuvette blank absorbance at secondary wavelength

The difference in absorbance at primary and secondary wavelength after


Ap-As subtraction of cuvette blank absorbance (that is, it is the difference of
Ap and As).

Click on to zoom in / zoom out the Y axis (Absorbance) scale to enlarge the graph within the
minimum and maximum absorbance for that curve. Click twice on the Reaction Curve graph to obtain
a zoomed view. Double-click again to zoom out.

Following are the other buttons present on screen:

Use navigation buttons to view the previous or next reaction curve number details.

PRINT: Click on this button to print the reaction curve details along with the graph.

EXPORT: Click on this button to export the selected reaction curve details along with the graph to
the specific location. After exporting the data successfully, the file name along with the path is
displayed as a message as well as in Indication text box in the bottom of the screen.

CLEAR: Click on this button to remove the details of the selected reaction curve number.

EM 200
User Interface 6-145

6.3.8.8 Other
Other option gives the report of Reagent Consumption,ISE Calibration,Reagent Bottle History and
Pack Details

Reagent Consumption screen in used to display the following information:

Total consumption of reagents

ISE calibration details

Use SHOW to view the data over the selected date range.

Use PRINT to print the report.

Use EXPORT to export data in excel sheet. Excel sheet is saved in the location C:\MultiXLLOG\ in
the *.XLS format.

Reagent Consumption

Reagent Consumption option is used to view the total number of times the each test are
performed for Patient, Calibrator (including Blank and Standards) and Control on the analyzer.

You can obtained the required data by selecting Reagent Consumption radio button and
entering date range. After selecting date, press SHOW to display the data.

See the following screen.

ISE Calibration

ISE Calibration option is used to display the ISE calibration details.

EM 200
6-146 User Interface

Select ISE Calibration radio option. This will displays the calibration details on the screen.

Use PRINT or EXPORT, as appropriate.

Reagent Bottle History

Using this option, you can view list of discarded / Non Discarded / ALL reagent bottles. The data
can be obtained by selecting date range in the From and To drop-down list.

To view the Discarded / Non-Discarded / ALL bottles, go to Reports > Others and select Reagent
Bottle History option, select required date range, select option Discarded / Non-Discarded / ALL
from drop down list as shown in below figure.

EM 200
User Interface 6-147

Then click on SHOW. Following screen with data will be displayed.

In Bottle no. column, the first three digits denote the Lot no. whereas the next

EM 200
6-148 User Interface

four digits denote the bottle no. of the Reagent Bottle.

Pack Details

This option is used to give details of System Pack Reagent kits. User can view list of details as
Pack no, Reagent name, Register date, Lot no, Mfg date, Expiry date, Open count no, Volume
scanned from pack up to 2 decimal, Bottle type, Bottle no, Discard status and date. The data can
be obtained by selecting date range in the From and To drop-down list.

To view the Pack details, go to Reports > Others > Pack Details option,select required date
range and then click on SHOW. The following screen with data will be displayed.

Open Test Count Details

This option provides details of open test count after registry of system packs and special cards.
User can view the list of details as Pack no, Reagent name (for special card it shows as CARD),
Registration date, Expiry date, Validity, Open Counts, Open Counts Balance and expiry of card.
The sorted data can be obtained by selecting ALL / Expired / Balance from drop-down list.

To view the Open Test Counts, select Reports > Others > Open Test Count Details, select
required options from ALL / Expired / Balance and click SHOW. The respective details will be
displayed.
Validity (days) If available on reagent pack / card, then it will be stored for expiry of days counts
loaded from the respective pack.In case, validity of Open-counts is not available from reagent
Packs / cards then it consider as no-expiry for those Open counts.
Open test counts will get incremented after registered of reagent packs or special cards.

EM 200
User Interface 6-149

System will consume the Open Test Counts in the order of their Expiry. Thus, open test counts
without Expiry (from existing packs) will be consumed at the end. It will not use Open counts after
respective Expiry (validity) & before its scan-date.
Open-channel tests will be allowed only till open counts is available

6.3.9 Master
Master menu is used to enter the master details such as area, doctor, analyst, laboratory,
manufacturer, reference range, unit, calculation formula and instrument.

Master consists of following screens. See for more details:

Area

Doctor

Analyst

Laboratory

Mfg

Reference Range

Unit

Calculation Formula

Instrument

EM 200
6-150 User Interface

Unit Conversion

6.3.9.1 Area
Area screen is used to enter the area (Location) from which the samples are collected. This list of
area is available in Patient Entry screen and hence for each patient a particular area can be selected.
This selected area (location) is printed in patient reports. See section Patient Reports.

See also:

Add area details

6.3.9.2 Doctor
Doctor screen is used to enter the name and demographics of referring doctor. This list of doctor is
available in Patient Entry screen and hence for each patient a particular doctor can be selected.

EM 200
User Interface 6-151

See also:

Add doctor details

6.3.9.3 Analyst
Analyst screen is used to enter the name and demographics of analyst. This list of analyst is
available in Patient Entry screen and hence for each patient a particular analyst can be selected.

EM 200
6-152 User Interface

See also:

Add analyst details

6.3.9.4 Laboratory
Laboratory screen is used to enter new or edit the existing laboratory name with their details. These
details will be printed as a header in the patient reports.

There is always a default row with laboratory name as My Laboratory marked with ** sign. This row
cannot be deleted but it can be edited. The name and address of this row is printed as header in the
patient reports.

This list of laboratory is available in Utility > Offline Results screen and hence for each patient a
particular laboratory can be selected.

EM 200
User Interface 6-153

See also:

Add laboratory details

6.3.9.5 Mfg
Mfg screen is used to enter new or edit the existing manufacturer name. This list of manufacturer is
available in Consumables screen and hence for each consumable a particular manufacturer can be
selected.

There is always a default manufacturer present marked with ** sign. This row can’t be deleted but it
can be edited that is the name can be changed.

EM 200
6-154 User Interface

See also:

Add manufacturer details

6.3.9.6 Reference Range


Reference range screen is used to enter the min and max years/months/days for a reference range.
This list of reference range is available in test Reference Ranges screen and hence for each test a
particular reference range can be selected and the min / max values can be entered.

There is always a default row present marked with ** sign. This row can’t be deleted, it can only be
selected.

EM 200
User Interface 6-155

See also:

Add reference range details

6.3.9.7 Unit
Unit screen is used to enter the unit. This list of units will be displayed in Test Details and Calculated
Item screen and hence for each test a particular unit can be selected.

EM 200
6-156 User Interface

See also:

Add unit details

6.3.9.8 Calculation Formula


Calculation Formula screen is used to enter calculation formula. This list of calculation formula is
available in Calculation Item screen and hence for each calculation item a particular calculation
formula can be selected.

Commonly (or frequently) used calculation formula are provided as default list. New formula can be
added to list, as required.

EM 200
User Interface 6-157

See also:

Add calculation formula details

6.3.9.9 Instrument
Instrument screen is used to enter instrument details. This list of instrument will be displayed in
Offline Results screen and hence for each offline result a particular instrument can be selected on
which result was measured.

EM 200
6-158 User Interface

See also:

Add instrument details

6.3.9.10 Unit Conversion


Unit conversion option is used to convert the unit of defined (default) test with appropriate factor.

1. Select the Unit conversion > from Master > there are radio buttons >Test and Calculated Item
and Check box for General > select TEST tab.

EM 200
User Interface 6-159

2. Select the test from the drop down list. From unit is mandatory and non editable, To unit > Select
the unit from the drop down list, Enter the appropriate factor for conversion.
3. Select Save > Test grid displays the test for which unit to be converted.

4. To convert unit for Calculated Item > Select the Calculated Item tab > from drop down list, select
the the calculated item, From unit is mandatory and non editable, To unit > to convert the unit
from the drop down list, Enter the appropriate factor to conversion.

EM 200
6-160 User Interface

.
5. Select Save > Calculated Item grid displays the test for which unit to be converted.

6. Tick the check box General for unit applicable to all tests and calculated items.

EM 200
User Interface 6-161

7. Select From Unit from drop down list > Select To Unit from drop down list
8. Click Save> General grid displays the unit to be converted which is applicable to all tests and
calculated items.

9. Preloaded unit conversions are displayed in their respective grids.

EM 200
6-162 User Interface

Unit Conversion can be also uploaded from CD via Parameter Management.

6.3.10 Utility
Utility allows user to perform the following operations:

Defining reagent bottles in different positions on reagent tray.

Taking full and selective database backup

Printing offline patient report

Recalculate results after result analysis

Utility consists of following screens:

Reagent Positions

Backup

Offline Results

Recalculate

6.3.10.1 Reagent Position


Reagent Position screen is used to define reagents bottles manually on Reagent Tray and view to
reagent details after reagent barcode or level scan.

To define reagent bottle manually, see section Defining Non Barcoded Reagents for more details.

If the reagent bottles are bar-coded, then they do not need to define positions as they are
automatically updated and displayed after the Reagent Barcode Scan. Reagent volume will be
updated automatically when the Volume Scan is performed through Status Monitor.

Also, using this screen you can also edit or clear the defined reagent positions.

See the following screen:

EM 200
User Interface 6-163

See the following screen option in details:

Clear position :Clear Position used to clear the defined reagent positions on the reagent tray. There
are two sub options:

All: To clear all the position on the reagent tray

Selective: To clear the specific position on the reagent tray.

Edit Position :Use this option to add or alter the reagent definition at a specific position.

Refresh Positions :This option is used to notify the availability of reagent in the reagent bottle(s) at
All or Selective positions on the reagent tray. During run, while aspirating the reagent, when a
reagent bottle is detected as empty bottle (no volume) then such reagent position is de-activated and
not used for further aspiration of reagent. Replace the empty reagent bottle on the reagent tray with
the filled reagent bottle. Then use this option, to notify the reagent availability to the system.

Scan pack: This option is used to scan the details of System Pack Reagent kits for Closed channel
reagents. Refer section Scan Pack for more details.

Transfer To Tube: This option is used to utilize tube by transferring reagent from scanned barcoded
reagent bottle to tube. For details refer section Transfer To Tube

Keys – Empty Bottle and Expired Lot: These keys indicate the meaning of the white and red
background color used for the rows of the positions grid displayed in the screen.

Empty Bottle: When a row is highlighted with white background color, it indicates that the

EM 200
6-164 User Interface

reagent volume at that position has become zero during run.

Expired Lot: An expired reagent lot on the reagent tray is highlighted with red background
color. The expired reagent is not aspirated during run. However, volume scan will be performed
for the position(s) having expired lot.

Expiry date of reagent bottle is compared with batch run start date, to decide
whether or not to aspirate the reagent during run.

Discarded: When a row is highlighted with dark orange background color, it indicates that the
reagent bottles at that position are discarded. It will be displayed after performing volume scan.

Expiry date of reagent bottle is compared with batch run start date, to decide
whether or not to aspirate the reagent during run.

The parameters in the grid are shown below:

Parameters Description
Position Reagent positions on Reagent Tray.
Reagent Reagent name.
Type Reagent type (R1/R2).
Bottle Type Bottle type of the reagent (Large / Small / Tube).
Rgt Vol (ml) Reagent volume scanned (ml).
Lot No. Lot number of the selected reagent
Expiry Date Expiry date of reagent as defined in consumables / read from barcode
Barcode Barcode label read on Reagent Barcode Scan.
“-“in this column indicates manual definition of reagents.
Stability inboard stability period as defined in consumables.
Unit Unit of the stability period, hours/days as defined in Consumables.

6.3.10.2 Transfer To Tube


Transfer To Tube option is used to allow tube in place of scanned barcoded reagent bottle.

Transfer To Tube option is available ONLY in Test Loader System.


Use “Transfer to Tube” option before starting the batch run.
During run, this option remains disabled.

Procedure for Transfer To Tube:

1. Scan barcoded reagent bottle from which you want to use reagent in the tube. Analyzer will get
details of reagent bottle on scan.
Barcode scan of each reagent bottle is required ONLY ONCE.
Ensure, the reagent pack from which you removed the bottle, is already scanned with

EM 200
User Interface 6-165

Test Loader Device.


2. Once barcode is scanned, fill the reagent into tube from scanned barcoded bottle only.
3. Place this tube at the place of same bottle position.
4. Click Utility > Reagent Position > Transfer To Tube.

5. Select the scanned reagent bottle position from which reagent to be transferred to tube.
6. Click Transfer To tube. Reagent position box appears.

8. Select the reagent position and Click OK.


9. Do not keep the same reagent (in bottle/tube) at multiple positions in reagent tray. In case, same
reagent is kept at multiple positions following message will be displayed.

Clear the other alternative position.

10.Click OK. Click Reagent position, reagent which is transferred to tube now appears in bottle
type as Tube.

EM 200
6-166 User Interface

11.Ensure sufficient reagent in tube to complete the run. If reagent is not sufficient then fill the tube
from same reagent bottle ( scanned in step 1 ).
In case scanned reagent bottle is over, scan another bottle from same system pack, follow the
procedure for Transfer To Tube to continue run.
In case all bottles of same system pack is consumed, scan new system pack ( Refer section
Scan Pack for more details ) and then follow the procedure for Transfer To Tube to continue run.
12.Start the RUN, analyzer will use reagent from tube to complete the run.
13.Before starting the next batch RUN, check if reagent in tube is sufficient to complete the run
otherwise fill the reagent from earlier scanned bottle into tube and start run.

Alternate, Expired and Discarded bottles of selected Reagent/Test will be


treated as Multiple Bottles and will be cleared during barcode scan.
If bottle associated with Tube is discarded then barcoded bottle of same
reagent on other positions will not be cleared.

Once Transfer To Tube is saved it cannot be reverted (it will be displayed in


Grey color)

If user wants to deselect this position then use either Clear Position option or
can keep any barcoded bottle on that position so that respective tube position
will be replaced by barcoded bottle after barcode scan.

Reagent Barcode Scan (Offline/Pre-Run/Add Reagent during run)

After Reagent Barcode Scan, Reagent Position marked with Transfer to Tube will be retained
across the batch till user either manually modifies the position or scans bar-coded Reagent bottle
on that position.

During Volume Scan

During Volume Scan, like bottle; when Reagent Absent, VOD or Liquid Level found different etc. is
reported then add respective tube Position to Refresh List; such that Tube is not used till user
refreshes the position (after taking appropriate action like fill tube from respective scanned bottle,
remove froth/bubble etc).

Track Reagent in Tube During RUN

System will track reagent volume used in tube for new as well as used reagent bottles.

System will report reagent absent based on volume availability.

If reagent volume in bottle is over, then associated bottle gets discarded.

Tube is not allowed for discarded reagent bottle, until next barcoded bottle is scanned.

EM 200
User Interface 6-167

6.3.10.3 Backup
Backup screen is used to take the backup of the patient database and to copy data to external
storage device.

Backup consists of following options. See for more details:

Backup Operations

Copy Data to External Storage Device

System Backup Restore

EM 200
6-168 User Interface

6.3.10.3.1 Backup Operations

Backup Mode: The display changes according to the selection and provides necessary guidance to
perform the operation.

Two options are available. Full Backup and Selective Backup. Only full backup is re-storable.
Selective backup is used to extract partial data for reference and cannot be restored back.

Backup Format: This drop down list is used to select the Mode of Backup. Available options are
Text, XML, XLS, and CSV. These options are available if the Selective Backup option is selected.

XML: This mode of backup stores the Backup Parameters in XML format

Text: This mode of backup stores the Backup Parameters in Text format

XLS: This mode of backup stores the Backup Parameters in Excel format

CSV: This mode of backup stores the Backup Parameters in Excel format.

The option Database will be displayed if Full Backup option is selected. Using this option, a backup
file of complete database is created in .BKP format along with .ARH file (.ARH file is a full backup of
Archived data).

Backup Path: Click on the Browse button to select the path or directory where the Parameters will
be backed up. It is not recommended to take the backup on the desktop.

Database: This mode of backup copies the entire database and stores it on the hard disk at the path
selected by user using Browse button.

Backup Option: A list of parameters is available for Backup if the user selects the Selective Backup

EM 200
User Interface 6-169

mode. The user can either check all the parameters using Backup Option/All checkbox or make a
selection individually using the checkbox placed against each parameter.

After the above operations have been done, click on Backup button to take a backup of selected
parameters.

Take Full Backup periodically, to avoid loss of data in case of PC crash.


Store the backup file .BKP, created through Full Backup; in an external media
like CD/DVD.

6.3.10.3.2 Copy Data to External Storage Device

The option is provided to copy database backup, log files and exported report files on USB storage
device.

On Windows Embedded 7 as Operating System, the USB storage device is blocked by default. To
copy data to USB storage device, log in as Administrator (windows user login) and run MultiXL.

Procedure to copy data on USB storage

1. Login as Administrator on the analyzer PC and start MultiXL software. (This step is only for
Windows Embedded 7 as Operating System on PC. It is not required for Windows XP and
Windows 7 Professional).

2. Insert the USB device.

3. Select Utility and click on Backup screen.

4. Following options are available to copy data on USB storage device. Select any one, as
appropriate:

Only Database: Database full backup, .bkp file will be copied to USB.

Only Log Files: Copy log files from the location C:\MultiXLLOG into USB device.

Both Log Files and Database: Both, Log files as well as Database as per specified
date, will be copied to the USB device. Following options are visible on selection.

Full

Analysis Data Required for Date

Folder To External Drive: The folder (along with its contents) selected from the
analyzer PC, termed as Source Location, will be copied to the USB device.

Exported Reports: System will copy all exported reports (present in designated folder
on hard disk drive) like Result Reprint, Test Statistics etc. to USB device.

Exported Reports: System will copy all exported reports like Result Reprint, Test
Statistics etc. to USB device.

5. User can select any one of the above options and select the Destination Location i.e. the
USB device.

6. Click the Copy Analysis Data button to copy data based on user selection.

EM 200
6-170 User Interface

7. On completion of data copy, message will be displayed as “Analysis data copied to the
destination location successfully” in the indication panel.
6.3.10.3.3 System Backup Restore

System Backup Restore option is provided to take backup of setting files and database on any other
D / E drive (auto drive selected by system) except from the C drive.
System Backup will be taken on MultiXL Shut Down. After taking weekly backup, old database
backup will be removed from c:\MultiXLLOG_Backup
User can also take system backup manually by following steps;

1. Click Utility > Backup >


2. Go to System Backup Restore

3. Backup Path is selected by the system.

4. Click on to take backup of setting, log and database files.

5. To Restore the files user needs administrative rights otherwise Restore button will remain

disabled . See Section User Rights for more details.

6. Run Database Utility to restore the backup of database. Refer section Database Utility Options

6.3.10.4 Offline Results


Offline Results screen enables user to enter data for any patient without having to actually perform a
test on analyzer. In this case, the application software is simply used to print the patient report. See

EM 200
User Interface 6-171

the following screen:

In case, if the result is entered for the test(s) that is available in test parameter then the result will be
saved with decimal places as defined in test parameter for the respective test. When the result is
entered for a new test i.e. for test that is not in test parameter; then the result will be saved with
decimal places as entered.

A description of the available parameters on this screen is as follows:

Item Description
Select the date for the patient result. It will always display the current date
Date
by default.
By clicking on the dotted button, select the name of the Laboratory from
Laboratory
the available list. Use Master > Laboratory screen to add a new laboratory.
By clicking on the dotted button, select the name of the Instrument (from
Instrument the available list) on which the test is conducted. Add a new instrument
name from Master > Instrument screen.
By clicking on the dotted button, select the Sample ID, if already defined
Sample ID
from Patient Entry screen or directly enter the sample id in this textbox.
Sample Type The user can select the Sample Type from drop down list.
Enter the name of the patient. The name of the patient will be displayed
Patient Name
automatically if the Sample ID is selected from the dotted button.
Age It displays the patient’s age..
Category This list displays the Category (Gender) of the patient.
Test Select the required test name from drop down list or enter a new test name

EM 200
6-172 User Interface

up to 5 characters.
Report Name Enter the Report Name of the selected test, for printing in Patient Report
Unit Select / enter the Unit of measurement for the test.
Normal Lower Limit Enter the Lower Limit of the Normal Reference Range for the Test. By
default, the reference range will be displayed when the test available in
Test Parameter is selected from the list of Tests.
Normal Upper Limit Enter the Upper Limit of the Normal Reference Range for the Test. By
default, the reference range will be displayed when the test available in
Test Parameter is selected from the list of Tests.
Result Enter the result for the Test.
Flag Enter the Flag associated with the Result.

On clicking PRINT button, the patient report will be generated. This result can also be printed from
Reports > Patient Report screen along with other results of the patient.

6.3.10.5 Recalculate
Recalculate screen is useful in recalculating results if any changes are made in the test parameters
or calibration data after analysis. This is particularly useful because one does not have to rerun a
sample if a mistake was made in test parameters or the calibration table.

Recalculate screen is not available during batch run.

Results of deleted sample IDs cannot be re-calculated.

EM 200
User Interface 6-173

Results of the test(s) having flags for Sample/Reagent absent cannot be re-
calculated.

To obtain recalculated result:

1. Select Result Date or Batch number or Test or Sample ID.

Sample ID textbox will be disabled if option Calibration or Control radio button is selected.

2. Select Patients or Calibration or Controls, as appropriate.

3. Click on SHOW button to view all the results.

4. Select the result(s) for which re-calculation is required. Click on the Recalculate button. The
re-calculated result and flag (revised as per re-calculated value) are displayed along with the
original result and flag.

5. Recalculated test results can be sent to Host by selecting the results and clicking on the
Send To Host button.
.
Send To Host button will be available if:

Patient or Control option is selected for showing results.

Host Connection option is activated in System Parameters screen.

During run, the Send to Host button is not available in the Re-calculated screen
and Result Reprint screen.

The option ‘Ignore Limits to Re-calculate Results’, allows user to display the
recalculated result with ignoring limit flags.
If this option is not selected, NA will be displayed in the Result column.

6.3.11 Service Check


Only authorized technical service personnel should operate this screen.

The options in the Service Check are not accessible if any maintenance/batch
run operation is running through the maintenance/status monitor screen. In this
case, the status message highlighted will be displayed in yellow color on the
Current State field as shown below.

When starting the Service Check activity, if dome is open (Level 1 and Level
2 ) then following warning message with alarm beep will be displayed and
error message will be reported in error display grid.

EM 200
6-174 User Interface

This screen is used to perform the-- service related activities.

See the following options:

Arm/Stirrer

This option is used for checking the alignment of the ARM Probe or Stirrer Assembly. Upon
selecting the Arm or Stirrer Option, the service personnel can check the alignment of the
respective assembly in trough, in sample tray (outer, middle and inner positions), in reagent tray
(outer positions and inner positions), in cuvette & in dilution cuvette. The operator can check
stirrer motor rotation speed at three different options as shown in picture below:

Initialize: This will initialize the arm/stirrer assembly as per the available options selected from

EM 200
User Interface 6-175

the list.

Dummy Run: On clicking this button, user can define the Sample, Diluent and reagent position.
After defining the respective positions, on clicking START button, Dummy run is initiated. On
clicking STOP button, Dummy run can be stopped when required.

Execute: This will move the respective assembly in the selected path. This is used to check the
motion of an arm/stirrer assembly in a particular path. Also for checking the Opto conditions.

DCF: This option is used to set the dilution calibration factor. The dilution factor should be entered
in the range 0.75 to 1.25. This feature is used in case if recovery of any of the dilution run is
improper.

Use the following procedure to set the dilution factor:

a. Manually calculate the Dilution Calibration Factor (DCF) using 5x dilution as shown below:

b. DCF = (Expected mean of 5x) / (Observed mean of 5x).

c. Click on the DCF button and enter the resultant DCF value in DCF text box and click on
SAVE.

d. This will save the value in the system. This factor will be transferred to analyzer and will be
stored in analyzer memory.

e. On every power on, this factor will be transferred to MultiXL.

f. MultiXL will multiply the results of dilution, any dilution for 2x to 150x, by this factor and
then result is declared.

In case of restore backup, it is recommended to restart the analyzer in order


to get correct calibration values including DCF.

Sample Tray

Initialize: This option is used to initialize the Sample Tray. (Position # 1).

EM 200
6-176 User Interface

Pulse: A PULSE button is also given for moving the sample tray step by step (one pulse gives
micro-step change between 2 positions).

Rotate to Position: This option is used for rotating the sample tray to “X” position depending on
the position selected by the service personnel. To move to next position Sample Tray needs to be
initialized.

Barcode Scan: This option is used to perform Sample Barcode Scan. All the Barcode(s) Read is
displayed on the screen (No cross check or verification of Duplication done). Display remains until
user performs some other operation. To view the same Barcode(s) again user has to click on the
button with Barcode label (This option is available until user remains on the Service Check
Screen).

ASP Barcode Scanner Beam ON/OFF: This option is used to Turn ON or OFF the ASP
Barcode Scanner Beam. On reading the Barcode the Beam turns OFF automatically.

Reagent Tray

Initialize: This option is used to initialize the Reagent Tray. (Position # 1).

Pulse: A PULSE button is given for moving the reagent tray step by step (between 2 positions).

Rotate to Position: This option is used for used for rotating the reagent tray to “X” position
depending on the position selected by the service personnel. (Positions are labeled as “01-I”, “01-
O” represents position One-Inner, One-Outer respectively).

Barcode Scan: This option is used to perform Reagent Barcode Scan. All the Barcode(s) Read
are displayed on the screen (No cross check or verification of Duplication / Checksum / Number of
Digits / Invalid Reagent Code / Invalid Bottle Type are done). Display remains until user performs
some other operation. To view the same Barcode(s) again user has to click on the button with
Barcode label (This option is available until user remains on the Service Check Screen).

RGT Barcode Scanner Beam ON/OFF: This option is used to Turn ON or OFF the RGT
Barcode Scanner Beam. On reading the Barcode the Beam turns OFF automatically.

RCT Tray

Initialize: This option is used to initialize RCT Tray to initial position. (Cuvette Number 39 in path
of Light Beam).

Pulse: This option is given for moving the reaction tray in micro steps (between 2 cuvettes) to
check for the opto-coupler alignment.

Rotate To: This option is used for rotating the reaction tray to “X” position.

CRU Unit

EM 200
User Interface 6-177

This function allows the service personnel to check the CRU Functionality. A CRU RUN CHECK
button.

Initialize: This option initializes the CRU Assembly to home position (UP).

Run Check: This option is given to check the functionality of the aspiration and suction probes of
the CRU in this mode.

DOWN: This option brings CRU Down in Cuvette.

Make sure the RCT Cuvettes are aligned before executing this command.

Following options are available after CRU is Down in Cuvette:

CRU Biohazard Suct’n Pump: This option turns the Bio-Hazard Suction Pump ON or OFF.

CRU Water Dispense Valve: This option turns the Water Dispense Valve ON / OFF.

To try this option, first brings CRU Down in Cuvette and keep Bio-Hazard
Suction Pumps ON to avoid any overflow and keep Overflow Suction Valve
OFF.

CRU Detergent Disp Pump: This option is used to turns ON / OFF the Detergent Dispense
Pump ON or OFF.

To try this option, first brings CRU Down in Cuvette and keep Bio-Hazard
Suction Pumps ON to avoid any overflow and keep Overflow Suction Valve
OFF.

CRU Overflow Suct'n Valve: This option turns Overflow Suction Valve ON or OFF.

To try this option, CRU Water Dispense and Detergent Dispense should be
OFF.

Syringe

EM 200
6-178 User Interface

Initialize: This option initializes the SYRINGE Assembly to home position.

Aspirate: The service personnel can check the ASPIRATE steps by entering the desired volume
in the field provided. The maximum volume that can be entered for ASPIRATION movement is 375
µl.

Dispense: The service personnel can check the DISPENSE steps by entering the desired volume
in the field provided. The maximum volume that can be entered for DISPENSE movement is 375
µl.

Valve and Pump

This option is used for checking the Valve operations for ARM Trough, ARM PROBE and Stirrer
Trough.

ARM Trough Valve: Turns ON or OFF the ARM Trough Valve.

ARM Probe Clean Valve: Turns ON or OFF the ARM Probe Clean Valve.

STIRRER Trough Valve: Turns ON or OFF the Trough Valve of Stirrer.

RCT/RGT TEMP: This option is used for displaying the RCT & RGT temperature. The RCT
Temperature should be within 37 +/-0.2 °C & the RGT temperature within 8-12 °C.

READ: This button starts reading operation and given Temperature Display till Stopped.

STOP: STOP button should be clicked before moving out of next screen.

Sensor Status: Status of all three temperature sensors are indicated as follows:

P - Present and within limits (36.8 ~ 37.2 °C)

O - Out of Range (Less than 36.8 °C or Greater than 37.2 °C).

A - Absent (This error will occur when there is no communication between the sensors and Micro
blaze)

L - Loose (This error will occur if sensors are not properly grounded.)

Communication

EM 200
User Interface 6-179

This option is used for checking the communication between PC and the analyzer. The service
personnel select the COM port and then click on the Check button.

Calibration

This section of Service Check Form is used to Calibrate ARM centering at various applicable
positions. Pre-requisites for this operation is to bring the ARM or STIRRER to required position
using the ARM/STIRRER Move options.

Clock Wise: Set direction of rotation for ARM / STIRRER as Clockwise.

Anti-Clock Wise: Set direction of rotation for ARM / STIRRER as Anticlockwise.

+++ : This button allows Course step movement of ARM / STIRRER.

+ : This button allows FINE step movement of ARM / STIRRER.

Accept: Saves the Course / FINE adjusted value of ARM / STIRRER in to local memory. Values
are not saved in Analyzer until “Save Calib.” Button is clicked.

Cancel: Cancels the locally Accepted Value(s) of Course / FINE adjustment(s) of ARM /
STIRRER.

Default: Cancels and reloads the default position of ARM / STIRRER at respective position of
calibration.

Save Calib: This option is mandatory after calibrating the ARM / STIRRER. The locally Accepted
values are Saved in the Analyzer Non-volatile memory and are used by Analyzer henceforth.

Calibration Menu

The following options are displayed when this button is clicked:

Read Default Calibration: This option will transfer the new default data (if any) from the ESW
(CPU) to PC.

Read Current Calibration: This option will transfer the current data from the analyzer (i.e.

EM 200
6-180 User Interface

EEPROM of CPU) to PC.

Load Default Calibration: This option is to load the default values from the PC to analyzer (i.e.
EEPROM of CPU).

Show Current Calibration: This option will displays the current calibration values in the
analyzer.

Before doing calibration Read Default and Current Calibration Values, as


these values are required to check limits of calibration steps at respective
position of ARM / STIRRER.

Current Calib Backup: This option will take the backup of current calibration which is saved in
the EEPROM to PC.

Restore Current Calib Backup: This option will load the backup file onto the EEPROM of the
CPU.

Misc Commands

This option helps to view the current MultiXL and Embedded Software(ESW) versions and also in
uploading the latest ESW version through the MultiXL.

On clicking the Misc Commands button two options appear as shown below;

On selecting Software Version the current Version Numbers for MultiXL Software and Embedded
Software Versions (Analyzer, Micro Blaze, FPGA, PDC and RCT Heater ,barcode and tag) are
displayed.

On selecting Upload ESW, the latest ESW version can be uploaded from the MultiXL itself. The
following screen is displayed on clicking this option;

EM 200
User Interface 6-181

The operator selects the path for the .mcs file through the Browse... option and clicks on Start
button. The process of uploading ESW is divided in two parts;
1. Erasing existing firmware from analyzer.
2. Uploading new firmware to analyzer.

If any of the below mentioned error occurs during this process, then user needs to start uploading
process again by clicking on Start Button.

List of Errors Error Codes


Erase not performed E1
File Format Error E2
File Checksum Error E3
Communication Error E4

Once the Embedded Software is uploaded successfully, a prompt for Restarting the analyzer
appears on the screen as shown below;

EM 200
6-182 User Interface

On restarting the analyzer, this screen shows the updated Embedded Software Versions of
Analyzer as follows;

Emergency Stop

This button will stop the current service related functionality and initialize the instrument. This
initialization ensures that all the assemblies are at their Home positions so as to begin the next
command.

6.3.12 Maintenance
During Maintenance activity when dome is open ( Level 1 and Level 2 ), then
following warning message with alarm beep will be displayed and error
message will be reported in error display grid.

EM 200
User Interface 6-183

Maintenance consists of following screens. See for more details:

Maintenance

Cell Blank

Maintenance Log

During Run, the Maintenance screen is disabled. User can access this screen
only after completion of the ongoing Batch Run.

After completion of Start-Up Maintenance activity, User will get intimation of


completion of Auto Maintenance activity.

EM 200
6-184 User Interface

6.3.12.1 Maintenance
Maintenance is used to perform the routine maintenance of the analyzer.

See the following sections for more details.

Span (Auto and Manual)

Wash

Dead Volume Calibration

ISE Unit

Auto Maintenance

6.3.12.1.1 Span (Auto and Manual)

Auto Span : This option is useful to view and adjust the photometer gains at different wavelengths.
The analyzer adjusts the photometer gains automatically, if you select Auto Span option, and click
on START button.

If the gain obtained during auto span is within the factory set limits, it is indicated by a green
background. And if the gain is not within the limits, then it is indicated by red background.

The photometer gains can also be adjusted manually, however it is not recommended.

If the absorbance of the DI Water placed in front of the cuvette is not between
0.05-0.085 Abs, then following corrective measures should be taken.

Check the cuvette

Perform cuvette rinse to ensure that the cuvettes are clean

Check the particular wavelengths and the photometer lamp

Call the service engineer

The Auto Span option will be the default option when the Maintenance screen is
clicked first time. Later it can be change, as appropriate.

Manual Span: This option is useful to view the absorbance and voltages at different wavelengths. It
is also used to view the photometer stability at different wavelengths.

EM 200
User Interface 6-185

Use the following procedure for using manual span:

1. Select the required wavelength using which the absorbance and voltage needs to be checked.

2. Select the appropriate cuvette number from the Cuvette No. drop down list.

3. Click on Start button.

4. The continuous online update of voltage and absorbance takes place and is displayed on the
screen.

5. Click on Stop once the check is performed.

6. User can select another wavelength to check the voltage and the absorbance at the other
wavelength. Again user needs to click on Start to start the reading and Stop to stop the
reading.

6.3.12.1.2 Wash

Use the following wash maintenance commands.

See the following wash commands in more details:

Prime Wash

This option is used at the beginning of the day before the Cuvette Rinse operation. The syringe
valve of the Probe is kept ON (depending on the time set by the user: Max time is 5 minutes) to
remove the air trapped inside the tubing. Also, the valves of the CRU tubing are kept open to
remove the air trapped in them. The following operation occurs after the button is clicked:

1. Machine Initializes.

2. CRU1 go in DOWN position in the RCT.

3. The syringe valves for CRU and Probe open sequentially.

4. The priming continues for “x” minutes.

EM 200
6-186 User Interface

5. After the priming operation is completed, the CRU initializes to home position.

Cuvette Rinse

On selecting this option, the user can perform a cuvette wash of all 45 cuvettes by clicking on the
START button. This wash is done using DI Water. At the end of Cuvette Rinse, the cell blanks are
updated automatically and can be seen by clicking on the Maintenance > Cell Blank screen.

Water Save

This option enables the operator to wash the reaction tray cuvettes with some cleaning solution
and fill all cuvettes with DI water at the end of a day’s work or at beginning of the day.

This operation can be performed any time using Water Save option.

To perform this, select Water Save, and click Start.

On clicking this button, the analyzer first washes all the 45 cuvettes with the cleaning solution
through laundry probes, and then using the Arm probe, the analyzer fills DI water in all the 45
cuvettes. This water remains in the cuvettes until the next run or cuvette wash/rinse.

Overnight filling of the cuvettes with DI water is helpful in loosening the dirt on the cuvette walls.
Perform water save daily, at the end of the day’s work.

Poor quality DI water should not be used for Water Save, as bacteria growth
can take place inside the cuvettes.

Auto Wash

The cuvettes, arm probes, and stirrer can be cleaned with external detergents or cleaning solution
through Auto Wash option.

Usually, the Auto Wash AC (Acid) or Auto Wash AL (Alkali) cleaning solution is used for this
operation.

It is recommended to perform this procedure once a week or when needed. If one is using latex
based assays regularly, it is recommended to perform a Cuvette Wash daily with Auto Wash AC
(Acid) or Auto Wash AL (Alkali) cleaning solution.

However, any other cleaning solution with appropriate concentration can be used for this
operation. These solutions are not kept in the detergent Can but in reagent bottles on the Reagent
Tray and in sample tubes on the Sample Tray.

Auto Wash option can be used instead of Cuvette Rinse option, when operator wants to use
external detergents/solutions to clean the cuvettes, probe, and stirrer.

Use 0.1N HCL for AC(Acid) and 0 .1N NaOH for AL(Alkali) to perform Auto
Wash.

Before starting the auto wash, you need to specify the cleaning solutions in the appropriate
position on the Sample Tray and Reagent Tray. See the following procedure.

EM 200
User Interface 6-187

1. Place 18 ml of Auto wash AC (Acid) Wash Solution at reagent position 1 and Auto Wash
AL (Alkali) Wash solutions at reagent positions 3 on the reagent tray (in 50 ml large
bottles).

2. Place 200 µl of Auto wash AC (Acid) Wash solution at sample position 1 and Auto Wash
AL (Alkali) Wash solutions at sample positions 3 on the sample tray (in 2 ml Cups).

3. Click on START button.

4. On clicking, a message box will be displayed indicating the user for placing cleaning
solution.

5. Click OK to perform auto wash.

If you want to stop the operation, you can click on the STOP button that is active after
the start button is clicked.

The following buttons will be displayed after performing the auto wash operation:

SHOW REPORT: This button will display the list of dates with time on which the auto-wash was
performed.

EXPORT: This option is used to download and save the auto-wash history in excel (.XLS) file in
location C:\MultiXLLOG.

It is recommended to perform the Auto Wash once a week or when needed.


If the user has not performed auto wash for 7 days, then on the next day,
MultiXL prompt the user to perform Auto Wash by displaying a pop-up
message on the right-bottom corner of the Status Monitor screen after first
batch run of the day.
Reminder pop-up will stays on screen, till user click on Close button.
This will be displayed once in a day.

EM 200
6-188 User Interface

Probe Wash

This option enables the operator to wash the probe with Auto Wash AC (Acid) or Auto Wash AL
(Alkali) cleaning solution at the end of a day’s work or at beginning of the day. This operation can
be performed any time using this option.

Follow the steps performed for probe wash.

1. Select the desired number of cycles from 01 – 09.

2. Click START button.

On clicking, a prompt window will be displayed for the user to enter/confirm the position of
the wash solution on the reagent tray.

In case, if the wash solution is already defined through Utility > Reagent Position, on
clicking START, the prompt window will displays the position number where the wash
solution is defined. You can edit the wash solution position by entering new position
number. Refer figure below.

Enter the wash solution position, and click OK, the Probe picks up the appropriate
volume of wash solution (in µl) and dispenses it in the drain with internal and external
cleaning.

The Probe wash action is repeated based on the number of cycles selected.

3. After the action is completed the analyzer gets initialized.

6.3.12.1.3 Dead Volume Calibration

This screen used to calibrate the Dead Volume for Sample Containers and Reagent Bottles. This
procedure should be carried out at time of software installation (application or analyzer embedded).

This procedure should be carried out only once.

EM 200
User Interface 6-189

Use the following procedure to carry out the dead volume calibration:

Reagent Bottle Calibration

The following steps should be performed to carry out the Sample container calibration:

1. Select the appropriate Reagent bottle type available from the SELECT CONTAINER TYPE
list for Dead Volume Calibration.

2. Pipette the exact amount as defined for reagent bottle in Calibrate with Volume .

3. Place the reagent bottle according to the bottle type on the position specified in the list.

4. Click CALIBRATE button.

If the reagent volume present in the specified reagent bottle is not approximately equal to
the volume with which it is to be calibrated, then message “Calibrated Value Out of Range
of Specified Value” is displayed.

Once the calibration process is completed, a message is displayed whether the


calibration is successful or failed.

If the calibration is successful then the values are automatically stored in the software.

Sample Tube and Cup Calibration

The following steps should be done to carry out the Reagent Bottle calibration:

1. Select the appropriate Sample tube available from the SELECT CONTAINER TYPE list for
Dead Volume Calibration.

2. Place the containers according to the container type on the position specified in the list.

3. Pipette the exact amount of volume as defined for sample tube in Calibrate with Volume.

EM 200
6-190 User Interface

4. Click CALIBRATE button.

Once the calibration process is completed then it is automatically stored in the software.

During calibration, if assembly error occurs; then the error message


“Dead Volume Calibration Failed” will be displayed on the error
message grid.

Default Calibration

The following steps should be done to reset the Dead Volume Calibration to Default:

1. User should click on DEFAULT button.

2. Select the container type from the list for which the Dead volume calibration needs to be
reset.

3. User can click on OK to reset the selected containers.

If the Application Software is changed, then the Dead Volume Calibration


settings are updated automatically and it can also be updated from the
instrument from Service Check > Read Current command. If any hardware
program is changed, then the Dead Volume Calibration should be repeated
again.

6.3.12.1.4 ISE Unit

These options are used to perform the routine maintenance, purging, cleaning and calibration on the
ISE unit. This option is available only when ISE (Ion Selective Electrode) unit is installed on the
analyzer.

EM 200
User Interface 6-191

See the following ISE maintenance commands in more details:

PURGE A

This is used to purge Calibrant A solution through the tubing from the reagent module to the ISE
Module. The ISE Module pumps Calibrant A from the reagent module through the ISE Module to
wash out the flow path.
On successful PURGE A cycle, it is indicated by green colored box. If it is failed, then red colored
box will be displayed on the right side of the ISE maintenance screen.

PURGE B

This is used to purge Calibrant B solution through the tubing from the reagent module to the ISE
Module. The ISE Module pumps Calibrant B through the ISE Module to wash out the flow path.

On successful PURGE B cycle, it is indicated by green colored box. If it is failed, then red colored
box will be displayed on the right side of the ISE maintenance screen

CALIBRATION

This cycle is used to calibrate the electrodes (Na, K, Cl, and Li) of ISE Module. The ISE
calibration range is as follows:

Na :52-64

EM 200
6-192 User Interface

K :52-64

Cl :40-55

Li :47-64

On successful calibration cycle, if the values are in range, it is indicated by green colored box. If it
is not in range, then coral (deep pink) colored box will be displayed.

Also, if the difference of the calibration values of (Na, K, Cl, Li) electrodes
and calibration values of reference electrodes (Ref_Na, Ref_K, Ref_Cl, Ref_Li)
are more than 1.5mV/decade, then the values are displayed in Yellow
colored box and considered as Unsuccessful calibration.

On clicking SHOW REPORT, it will display the last 30 calibration values. See figure as shown
below.

The column Status displays the status of the electrodes after calibration.

Scroll the horizontal bar to view the complete report.

The appropriate status (Partial, Failed or Pass) will be displayed on the basis of following

EM 200
User Interface 6-193

conditions:

Pass: If all electrodes are calibrated successfully.

Partial: If at least any one of the electrodes is calibrated successfully.

Failed: All electrodes are unsuccessfully calibrated.

CLEAN

This command is used to remove protein build-up from the ISE Module electrodes. The Clean
command should be performed once per 24-hour period.

On successful operation, it is indicated by green colored box. If it is failed, then Coral (deep pink)
colored box will be displayed.

PUMP CALIBRATION

This cycle is used to calibrate the peristaltic pumps of the ISE Module.
On successful operation, it is indicated by green colored box. If it is failed, then Coral (deep pink)
colored box will be displayed.

BUBBLE CALIBRATION

The bubble calibration command is used to allow the module to reestablish a baseline for
detecting air-liquid interfaces. It can also be used as a diagnostic tool to see if the bubble detector
is functioning properly.

On successful operation, it is indicated by green colored box. If it is failed, then Coral (deep pink)
colored box will be displayed

MAINTENANCE

This is used to clear fluid from the flow path of the ISE Module, and to pause the Sip Cycle.

The Sip Cycle is used to refresh the Calibrant A in front of the electrodes. Every 30 minutes after
the last sample is run, the ISE Module will automatically run a Sip Cycle. No command is
required from the host analyzer to initiate a Sip Cycle. The ISE Module automatically clears the
flow path, next the ISE Module dispenses 36 µL of Calibrant B into the Sample Entry Port, and it
pulls it past the electrodes using the waste pump. The ISE Module then dispenses 95 µL of
Calibrant A into the sample entry port, and positions it in front of the electrodes.

EM 200
6-194 User Interface

On successful operation, it is indicated by green colored box. If it is failed, then coral (deep pink)
colored box will be displayed.

PRIME A

This command is used to prime Calibrant A solution from the reagent pack. It is performed after
installing the new ISE Reagent Pack.

PRIME B

This command is used to prime Calibrant B solution from the reagent pack. It is performed after
installing the new ISE Reagent Pack.

SHOW BUBBLE CALIBRATION

This command is used to display the bubble calibration values.

SHOW LAST SLOPE CALCULATED

This command is used to display last calibration values for the Na, K, Cl, and Li.

SHOW ISE PUMP CALIBRATION

This command is used to display the ISE pump calibration values.

READ ISE VERSION

This command is used to display the ISE module software version.

6.3.12.1.4.1 ISE Command Buttons

Following command buttons are provided for ISE:

ISE ON

Click on this button to start the ISE unit.

When this button is pressed, the system will check for the (calculated) volume of Calibrant A and
Calibrant B.

In case, if the remaining (calculated) volume of any Calibrant is less than 10% of the total Volume
then the message “ISE Reagent Pack Volume Low (Less than 10% of Total Volume)” will be
displayed in error grid and logged in the database. This message is only for the user information.

In case, if the remaining (calculated) volume of any Calibrant is below the respective threshold
level, then the alert message “ISE Reagent Pack Volume Very Low (Less than 3 Days Sip)” will
be displayed with red background in error grid.

Once the check is completed, the ISE reagent pack Lot Number and Expiry date will be
displayed. After this, you system is ready for processing the batch run and other maintenance
activities.

ISE OFF

Click on this button to stop the ISE unit.

EM 200
User Interface 6-195

6.3.12.1.5 Auto Maintenance

By default, the auto maintenance start-up actions are performed automatically at the beginning of the
day when the application is started first time. This is an automatic service action that does not
require manual intervention.

When starting the Auto Maintenance activity, if dome is open ( Level 1 and
Level 2 ) then following warning message with alarm beep will be displayed
and error message will be reported in error display grid.

Ensure to close dome properly before proceeding.

During Auto Maintenance when dome is open ( Level 2 ), ARM movement will
be stopped immediately when activity requiring ARM movement is still
pending and error will be reported in error display grid.

Remaining Auto Maintenance activity will be continued as arm movement is


already executed for these activities.

This operation can be initiated any time from the Auto Maintenance from the Maintenance screen:

The auto-maintenance at startup is initiated to perform automatically when the


analyzer and computer are turned on for the first time each day.

See the following procedure to perform auto maintenance and shutdown operation manually:

Initiate Auto Maintenance at Start-up

1. Select START-UP.

2. Click START.

On clicking, the following window will be displayed.


.

EM 200
6-196 User Interface

3. Click OK to continue with the maintenance.

This will start the auto maintenance operation.

Service actions during auto maintenance at Startup

Startup

1. Priming of laundry unit and SRPT probe with DI water for one minute (automatic step).

2. Auto Span operation (automatic step).

3. Cuvette rinse operation (automatic step).

4. Perform priming of SRPT syringe for one minute (automatic step).

If an error occurs at any of the steps mentioned above, then;

1. Description of the error occurred is displayed with an option for user to


“Retry” or “Cancel” maintenance.
2. If the user clicks “Retry” then a re-attempt is made to continue auto-
maintenance and resume from the activity in which error was
encountered without repeating the previous activities that were
completed successfully.
3. Analyzer will reattempt to perform auto maintenance for 2 times. Failing
which, it will cancel Auto-Maintenance on Startup activity automatically.
ISE Pump calibration, when fails/not in range; is not re-attempted.
Description of errors occurred during auto-maintenance can be
viewed at a later date from Reports > Error Log screen.

Initiate Auto Maintenance at Shutdown

1. Select SHUTDOWN.

2. Click START.

On clicking, the following window will be displayed.

EM 200
User Interface 6-197

Put the required amount of cleaning solution on the mentioned reagent and sample
position, and then click OK.

This will start the maintenance operation and the instrument will be shutdown once it is
completed.

Service actions during auto maintenance at Shutdown

Shutdown

1. ISE clean (only if ISE module is attached)

2. Analyzer initialization.

3. Volume scan of cleaning solution.

4. Cuvette rinse operation.

5. Probe cleaning with cleaning solution for 3 times.

6. Internal and External probe cleaning with DI water in trough for 3 times.

7. Probe cleaning with DI water for 3 times.

8. Water save operation

9. Shutdown

During auto-maintenance at shutdown, if any errors (such as VOD, Wash


solution absent, or Hardware related errors) are reported, then those error
will be saved in the MultiXL database which can be later viewed in
Reports > Error Log screen.

6.3.12.2 Cell Blank


Cell Blank screen enables user to view the cuvette blank absorbance values (obtained with in air or in
water during cuvette rinse) at any particular wavelength.

EM 200
6-198 User Interface

This menu enables the user to view the cuvette blank absorbance values (obtained with DI water in
the cuvette) at any particular wavelength. The screen displays the cuvette blank for the requested
wavelength. Wavelength can be selected by the pull-down option provided on the left side of the
screen. Use navigation buttons to view the cuvette blanks for the next and previous wavelength.

The values on the cuvette blank value table display should be between minimum and maximum cell
blank range. In case if any wavelength is measured out of range, it is indicated in red color on top of
the screen. See the following figure:

There is also a GRAPH button available, through which the cell blank reading for particular
wavelength can be viewed in a graphical format. The cuvette blank table consists of three sections.

EM 200
User Interface 6-199

Present abs: It is the absorbance of the cuvettes with de-ionized water measured after the last run or
Cuvette Rinse.

Previous abs: It is the absorbance of the cuvettes with de-ionized water measured after the second
last run or Cuvette Rinse.

All dirty cuvettes will be skipped and no sampling will be done in dirty cuvette.

Graph: On clicking GRAPH button, the user can view the absorbance in graphical format for the
required wavelength. To view the graph, you need to select the required wavelength from the Select
Wavelength drop-down list, and then select the appropriate graph type from the Type option.

Three options are available to view the graph:

Present: This option will displays the previous absorbance graph obtained for the selected
wavelengths.

Previous: This option will displays the present absorbance graph obtained for the selected
wavelengths.

Both: The comparison of both graphs (previous and present) can be viewed using this option.

The maximum and minimum acceptable value of the cuvette blank absorbance can be set in the
Settings > System Parameter menu. If the absorbance of the cuvette blank exceeds the set
maximum blank absorbance, then that particular cuvette absorbance is indicated by red font color.
On the other hand, if the absorbance of the cuvette blank is below the minimum acceptable
absorbance, then it is indicated by Blue font color.

The values on the cuvette blank value table display should not exceed 0.1 normally. Cuvette Rinse
and/or Auto Wash procedure from Maintenance must be performed, if the cuvette blanks are higher

EM 200
6-200 User Interface

than the maximum limit. If the Cuvette O.Ds exceeds 0.2 Absorbance, the cuvette should be
replaced with a new cuvette or should be cleaned externally using fresh water. This procedure should
be done daily before starting the batch.

6.3.12.3 Maintenance Log


Maintenance Log screen is used to review the maintenance operations performed on the analyzer
within specific period.

Screen shows the list of maintenance activities performed during the selected period with details
such as its status, source from which the activity was initiated.

The system records details like which activity is performed on what date, what was its source, and
what was the status.

Maintenance logs are extremely useful for troubleshooting purpose, as they provide a record of all
activity performed on the system and may shed light on hard-to-spot symptoms.

System keeps records of maintenance performed on the analyzer. To view the list, Select date
range From and To.

List can be further filtered out according to Source, Activity and Status.

Source indicates the domain from where the maintenance activity is initiated. Sources can be
Maintenance screen, Shutdown screen, Application Start (start of application).

Activity indicates the type of maintenance operation performed.

Status indicates the status of activity, such as successful, unsuccessful, and performed.

A : Select the date range.

EM 200
User Interface 6-201

B : Select the source from which the maintenance activity is initiated.

C : Select the type of maintenance activity.

D : Select the maintenance activity status.

E : Use Show for displaying records and Print to print maintenance report.

F : Click on the icon to view the list of error encountered during the operation.

6.3.13 Settings

Settings menu allows you to perform the following operations:

System Parameters

Carryover Pairs

Test Sequence

Re-run Flags

User Rights

Host Settings

6.3.13.1 System Parameters


Settings menu allows you to configure the behavior of the analyzer's hardware and application
software. These settings can be modified using EDIT button at the bottom of the screen.

EM 200
6-202 User Interface

Item Description

Laboratory Name It displays the default laboratory name which will appear as header in the
printed patient reports. The default laboratory name can be changed
through Master > Laboratory screen.
Refer section Laboratory for more details.

Default Language The default language for the software screen can be set using this button.
Refer section Setting UI Language for more details.

Clear Screen upon This drop-down list is used for selecting the clearing of the input screens
Save such as Patient Entry, upon Save operation. The available options are
Yes, No, and User Confirmation.
On selecting option Yes, the screen will be cleared upon Save.
On selecting option No, the screen will not be cleared upon Save and will
display the saved data. Click on CLEAR button in the respective screen
to add new data.
On selecting option User Confirmation; every time upon Save, user will be
prompted to choose the option to clear the screen.

Confirmation Message This check-box is used to select the availability of confirmation message.
Default is checked. If it is checked, on performing any critical operation
such as SAVE or DELETE, a confirmation message will be displayed.

Auto Copy Calibration Tick this check-box to automatically copy the calibration across test(s)
with same assay type and specific curve type (either both linear or both
non-linear requiring the same number of calibrators); sharing the same
Reagents.
This option will be useful for the test(s) created using COPY TEST option
in Test Parameter screen.

EM 200
User Interface 6-203

Patient Report This option allows the user to print the Patient Reports automatically
during the batch run, as soon as all the results of a sample are available.
Patient Report can be printed with or without the header.
The following options are available for selection:
OFF
Normal with Header
Normal without Header
Multicolumn with Header
Multi column without Header
Profile with Header
Profile without Header
Graphical with Header
Graphical without Header
Select OFF, in case automatic Patient Report printing is not required.
Patient Report can be printed in any of the 4 different formats, with or
without the header.
Make sure to select the desired Report Options from the Reports >
Patient Reports screen. This will determine whether or not to print
Location (area), Analyst, Sample Remarks and Patient Remarks on the
Patient Report.
IMPORTANT: Set Printer ON, when Online Report or Patient Report
is selected to print.

Online Report Tick this check-box to print the results (list in columnar format) during
batch run.
The following columns will be displayed: Sample position number,
Sample ID, Test, Result, Unit and Flag.
IMPORTANT: Set Printer ON, when Online Report or Patient Report
is selected to print.

Print Negative Result Tick this check-box to print the negative results as it is. On un-ticking
this check-box, the negative results will be printed as 0 (zero) in Patient
Report, instead of negative value.
However, irrespective of the option selected; the screen will always
display the results as it is (negative) and the Online (results) Report will
also print negative values.

Footer Enter the foot note to be printed in the Patient Report (at the bottom).
See Patient Reports.

Signature Two text boxes are available to add the signature on the printed patient
report. It will be displayed in the footer (or bottom) of the printed patient
reports.

Top Margin(inch) and Set the top and bottom margin, in inch, for the printed patient report. The
Bottom Margin(inch) extra space will be added to the top and bottom of the printed patient
reports, as per margin selected.

Analyzer Port Select the COM Port of the PC, at which the Analyzer is connected.
Default port is COM 1.

EM 200
6-204 User Interface

Host Connection Tick this check-box to activate the data transmission (patient
demographics, work list and test results) with LIS. Default is checked.
Un-checking this option will close the LIS connection from the analyzer
PC.
When Host connection is activated, configure other parameters from the
Host Settings screen.

Open Channel Test This drop-down list is used to select setting for test parameters. Three
options are available Open, Semi-Closed and Closed.
If Open option is selected, all the inputs on the test parameter
screen are editable and also new tests can be added.
If Semi-Closed option is selected, only some of the inputs on
the test parameter screen are editable for the pre-defined tests.
A new test can be added.
If Closed option is selected, the inputs on the test parameter
screen are non-editable. A new test cannot be added.
This option may be used to secure the Test Parameter screen.
This option will be disabled in closed system.

RCT Temperature It displays the RCT Temperature in C. The default value is 37 C.

RCT Temperature It is used to set the allowable fluctuation in RCT Temperature. Enter the
Range range between 0 and 0.5.
During batch run, when the RCT temperature fluctuation is outside the
specified range, warning message “Temperature out of Range” is
displayed on Status Monitor, logged in Error Log. All the results (except
ISE) in process will be declared with @TMP flag.

RGT Temperature This field displays the RGT Temperature in C. This value is 8 C.

RGT Temperature This field is used to set the allowable fluctuation in RGT Temperature.
Range Default value is 4 C. User can enter the range between 0 and 4.

Sample Barcode This option is used to select the availability of Sample Barcode. Default is
ticked (available).
When the sample barcode identification is not desired, un-tick this option
& SAVE. In such case, in Patient Entry screen, the Barcoded option
Sample Definition Parameters and Sample Barcode Scan in Status
Monitor > Barcode Scan will be disabled and entry of sample position
number is mandatory.

Reagent Barcode This option is used to select the availability of Reagent Barcode. Default
is ticked (available).
When this option is un-ticked, Reagent Barcode Scan option in Status
Monitor > Barcode Scan is not available. Reagents should be defined
manually from Utility > Reagent Position screen.

EM 200
User Interface 6-205

Hibernate After This option is visible only if sleep mode hardware is installed on the
analyzer.
This text box is used to enter time in minutes for the analyzer to
hibernate (or sleep). The default hibernate time is 15 minutes. The
analyzer automatically hibernates if the analyzer is kept inactive or
standby for the specified time in minutes. User can specify the time to
hibernate between 10 minutes to 60 minutes.
User can manually hibernate the analyzer, if required, by using
Hibernate option in the main menu layout. See section 7.9 Hibernate/
Wak e-Up for more details.
When an analyzer goes into hibernation, it shuts down the Halogen
Lamp, Vacuum pump and DI Water Pump.

The analyzer will automatically hibernate if user activity is not


performed after the following operations:
After Completion or termination of batch run, when Analyzer is
standby for specified time.
If the analyzer is standby for 1 hour while in the Maintenance
screen.
After performing the Auto Maintenance activity on start of the
day, when Analyzer is standby for specified time.
NOTE:
Analyzer will never hibernate if the Service Check screen
is open.
Analyzer will take 70 seconds approximately to wakeup
from the sleep mode (hibernate).

ISE Module This option is used to select the availability of ISE.


When un-ticked, ISE options are not available for scheduling & for batch
run.

Li in ISE Using this option Lithium (Li) test can be disabled or enabled. However,
by default this option is disabled and needs activation by the user. If
activated, Lithium test will also be performed and results will be displayed
when ISE is performed.

Machine SR. NO. Enter the serial number of machine (analyzer).

Action On ISE Calib Set any one of the action, as appropriate.


Failed The selected action will be performed if the ISE calibration on start of the
batch run fails.
Stop Run
Batch run stops. User can take corrective action and calibrate ISE
manually.
Proceed With the Calibration in range
When this option is selected, batch run starts. Results of only
those ISE test(s) will be declared for which calibration is reported
within range.
Skip ISE Test and Proceed
Batch run starts with only photometric test(s), skipping ISE
schedules.

EM 200
6-206 User Interface

Minimum Cell Blank Enter the Minimum Cell Blank Absorbance from 0.01 to 0.05. If the
absorbance of the cell blank falls below this limit, then the colour of the
cuvette Absorbance value in the Maintenance > Cell Blank screen will
change to Blue. Default value is 0.03.

Maximum Cell Blank Enter the Maximum Cell Blank Absorbance from 0.1 to 0.2. If the
absorbance of the cell blank falls above this limit, then the colour of the
cuvette Absorbance value in the Maintenance > Cell Blank screen will
change to Red. Default value is 0.2.

Extrapolation Specify the desired percentage to extrapolate the calibration graph to a


particular percentage. Value between 0 to 20% can be entered. If the
value is 0, the graph is not extrapolated.

Container Type Set the default container type from the list.
The selected option will appear as the default container type while adding
samples in the Patient Entry screen.

Threshold Level for Low Set the required threshold level percentage with respect to the Bottle
Volume in RGT Bottles Capacity, for low reagent volume indicator for the following reagent bottle
types :
Large
Small
Tube
By default, 20% for large bottles (50 ml), 10% for small (20 ml), and 25%
for small tube is defined.
Specified percentage is used to indicate Reagent Volume Low, with
yellow color, on Reagent Tray screen of Status Monitor.

Min QC Result for Lab Set the minimum QC points required for lab mean.
Mean Enter value between 1 to 999. Default value will be 20.

6.3.13.2 Carryover Pairs


Analyzer typically uses probe to dispense reagents, and this probes are exposed in rapid
succession to a wide spectrum of different reagents. A very real concern with analyzers is reagent
carryover, that is, reagent from an initial assay clinging to a reagent probe and contaminating the
reaction mixture of the next test immediately following the initial assay.

Using this screen, you can define the forbidden pair for a particular chemistry.

EM 200
User Interface 6-207

In order to maintain consistency and accuracy of the results an additional wash


cycle before/after a particular test can be defined.

Steps for Additional Wash before a particular Test:


Click on SETTINGS and select CARRY OVER PAIRS.
In *Contaminant (1st) Test drop-down menu select**Any Test**
In *Contaminated (2nd) Test drop-down menu select ‘Test’ (select test which requires additional
wash)
Select appropriate wash type / volume / cycles.
Click on SAVE.

Steps for Additional Wash after a particular Test:


Click on SETTINGS and select CARRY OVER PAIRS.
In *Contaminant (1st) Test drop-down menu select ‘Test’(select test which requires additional
wash).
In *Contaminated (2nd) Test drop-down menu select **Any Test**
Select appropriate wash type / volume / cycles.
Click on SAVE.

Parameters Description
Contaminant Select the first contaminant chemistry.
(1st)Test
Contaminated Select the second chemistry that could get contaminated.
(2nd) Test
Skip Cuvette This option is used to skip the cuvette. Whenever a contaminated test comes
under a cuvette where the contaminant test has been performed (consecutive
use), the cuvette will be skipped automatically.

EM 200
6-208 User Interface

Wash The user can select the wash whether for that pair, a Reagent 1 or Reagent 2 or a
Detergent Wash or both Reagent 1 and Reagent 2 are required.
Select the following options, as appropriate:

No Wash

Reagent 1 Wash

Reagent 2 Wash

Reagent 1 and Reagent 2 Wash

Detergent Wash

Wash Cycles It displays the number of times the Wash cycle is performed. The default value is
1.
R1/R2 Volume If reagent Wash is selected, then the user can define the R1 and R2 volume to be
aspirated from the contaminated test for cleaning the probe.
System Wash Select this option for a pair of tests. In System Wash, the Arm will be washed
internally and externally with internal DI water at trough, after picking up
contaminant test.

When this option is selected, the Wash drop down list will be disabled.

For Detergent Wash, prepare Wash Solution (preferably phosphate-free neutral


1% Extran or 0.025% Hypochlorous Acid). Also, the same pair cannot be
programmed for 2 different type of wash.

In Carryover Pair screen, DELETE button will be disabled for default loaded
carryover pairs.

6.3.13.3 Test Sequence


Test Sequence is used to define the sequence of tests to display on screen and print in patient
report.

Processing the sequence of the test(s) can also be set from this screen.

Tests can be arranged in sequence using the following four available options:

Test display sequence

Test process sequence

Print sequence for patient reports

Profile sequence for patient reports

EM 200
User Interface 6-209

6.3.13.3.1 Test Display Sequence

This option is used to set the sequence of tests. Once the test display sequence is set, the test(s)
will appear in the specified sequence in the following screens:

Patient Entry

Reports

Search

Test Parameter > Test Details

Test Parameter > Test Volumes

Test Parameter > Reference Ranges

Profiles/Calc > Profiles

QC Calibration > Calibration

The sequence of test can be displayed in alphabetical order (ascending and descending). Use
difference modes to set the order as per requirement.

It also provides a drag-and-drop mechanism to let you directly rearrange the test in a sequence within
the grid.

6.3.13.3.2 Test Process Sequence

This option is used to set the process sequence of photometric tests, before or during the run.

It is useful in avoiding contamination by forbidden pairs that may come together during the run.

Dynamic Process Sequence

EM 200
6-210 User Interface

To eliminate carry over between the last test executed and next test to be executed, we can select
USE DYNAMIC PROCESS SEQUENCE.

In this, the tests are rearranged in a sequence that the carry over washes are reduced to the extent
possible maintaining higher throughput.

To set the test process sequence to dynamic process sequence, select option TEST PROCESS
SEQUENCE, tick on the adjoining check box USE DYNAMIC PROCESS SEQUENCE and then click
SAVE.

In Closed System, two options will be visible on selecting the TEST PROCESS
SEQUENCE option.

Closed Channel First and then Open Channel

Open Channel First and then Closed Channel

The closed channels tests and open channels tests are displayed in separate
sections.

On selecting any of the option, tests assigned for each sample will be
processed according to the test sequence as defined in the Closed Channels
Tests grid and Open Channel Tests grid. See the following figure for more
details.

EM 200
User Interface 6-211

Sequence of closed channel tests can not be changed. Sequence of open


channel tests can be changed, if defined.
Refer section Test Parameter screen for more details.

Copied test with Closed reagent in Test Parameter is non editable in the list of Test Process
Sequence of closed channel test.

Copied test with Open reagent in Test Parameter is editable in the list of Test Process Sequence
of open channel test.

For Particular Test if Open/Closed reagent is changed from Test Parameter >Test Details, then this
test will be displayed in Test Process Sequence list in respective section of open / closed channel
test based on the changed reagent type.

6.3.13.3.3 Print Sequence For Patient Reports

This option is used to set the sequence of test and calculated items to be printed on the patient
reports.

EM 200
6-212 User Interface

6.3.13.3.4 Profile Sequence For Patient Reports

This option is used to set the sequence of profile to be printed on the patient reports in Profile format.

EM 200
User Interface 6-213

6.3.13.4 Re-run Flags


Rerun Flag screen is used to select the rerun flags for which auto-rerun of the test is required during
batch run.

If a particular flag is de-selected, then auto-rerun will not be performed when the flag is issued along
with the result for that test, even though auto-rerun is selected for the test from Test Parameter
screen.

6.3.13.5 User Rights


User Rights screen allows administrator to perform following operations:

Create and delete user ID and password

Provide access rights to new and existing users

See section Access control for more details.

Guest is the default user name with all user rights. See the following figure.

EM 200
6-214 User Interface

6.3.13.6 Host Settings


Host Settings screen is used to define the settings required to establish the communication between
the analyzer's Data Station and Host PC (LIS software).

EM 200
User Interface 6-215

Depending on your network type (Peer-to-peer or LAN), choose the appropriate communication mode
from the screen. They are:

RS 232C

TCP/IP

Select RS 232C, if the analyzer and PC is connected in peer-to-peer (through serial port).

Select TCP/IP, if the analyzer and PC is connected in LAN (Local Area Network).

See section Connection to Host PC for more details.

See the options available on screen:

Send Patient Results to Host

Send Control Results to Host

Send Limit Values for flagged Results

Schedule Test Again

Send Sample Position

EM 200
6-216 User Interface

The additional buttons available on this screen are as follows:

CHECK CONNECTION: This button is used to check the communication between Host and analyzer
PC.

SAVE: This button is used to save the settings.

CLEAR: This button is used to clear the changes.

EDIT: This button is used to edit the changes.

CLEAR RESULT QUEUE: On clicking this, button, the ongoing result data to LIS will be stopped.

HELP: This button displays the ASTM HOST help file in more details.

This screen is editable only, if Host Connection option is ticked.

6.3.13.6.1 Send Patient Results to Host

When this option is selected, the patient results, which are generated during the batch run will be
automatically sent to LIS.

After selecting the option, click SAVE to save the settings.

For any test containing "µ" in unit, "µ" gets transmitted as "u" to LIS.

6.3.13.6.2 Send Control Results to Host

When this option is selected, the control results, which are generated during the batch run will be
automatically sent to LIS.

After selecting the option, click SAVE to save the settings.

6.3.13.6.3 Schedule Test Again

When this option is selected, system will accept redo test action received from LIS and re-do the
tests for that sample.

6.3.13.6.4 Send Sample Position

When this option is selected, patient results sent to LIS will be displayed with associated sample
position number and disk number.

6.3.13.6.5 Query Sample at a time

After Sample Barcode Scan, MultiXL application will request LIS for downloading test details for the
samples scanned during run or Sample Barcode Scan. MultiXL will query either 1 sample or 5
samples at a time. Select appropriate option from the following, in consultation with LIS vendor.

Single

Multiple(Max 5 Samples)

EM 200
User Interface 6-217

6.3.13.6.6 Checksum

This option allows user to enter character encoding set for all checksum calculations.

In order to support data transmission in Russian and any Cyrillic language the checksum calculation
needs to be in UTF-8 encoding.

It is purely a user-preferred option w hich is set to the default mode by the


system application.

6.3.13.6.7 Send Limit Values for flagged Results

Select this option to send limit values to LIS for flagged patients’ results instead of sending ‘NA’. It is
only applicable for flags TEC-H, TEC-L, RANGH, RANGL, AbsLIM, LINXX and P* (prozone limit).

After selecting the option, click SAVE to save the settings.

6.3.14 Hibernate/Wake-up
This option is used to manually hibernate or wake-up the analyzer. See the following section for more
details:

Hibernate

Wake-up

This feature is hardware dependent and option is visible only if the sleep mode
hardware is installed in the analyzer..

When the system is in hibernation state, the following activities will wake-up the analyzer
when you click on the following screen:

Service Check

Maintenance

Sample Barcode Scan, Reagent Barcode Scan and Volume Scan in Status Monitor
screen

Shut Down

Before shutting down the analyzer, a confirmation message is displayed “Do you really want
to Wake Up?” If clicked Yes, then it will wakeup.

6.3.14.1 Hibernate
To hibernate, use the following procedure:

1. Click on Hibernate.

A message will be displayed.

EM 200
6-218 User Interface

2. Click Yes.

On clicking, analyzer will go to power saving sleep mode and the option will be displayed as
Wake Up.

6.3.14.2 Wake-up
To wake-up the analyzer, use the following procedure:

1. Click on Wake Up.

A message will be displayed.

2. Click Yes.

Analyzer will come out from hibernate (power-saving sleep) mode and again the option will be
displayed as Hibernate.

6.3.15 Archive
The archive data is the process of moving patient results to separate data storage for long-term use
Data archives consist of older patient data which can be used for future reference, if required.

Data archiving improves the performance of (Live) database with the following key benefits.

Faster search of patient results

Quick accessibility of patient results

EM 200
User Interface 6-219

Reduces the amount of storage required for patient results.

For archiving and restoring patient data, the Archive option will appear on the main menu as shown in
the following figure.

Archive option on the main menu screen

Initially, when the software is installed, this option is not visible. It appears only when the patient
results reaches to a specific limit. In this case, at specific time interval, software automatically
prompts the user to archive the data when it is necessary. Thereafter, this option will be always
visible.
It is advisable to archive the older patient results to separate data storage.

It is mandatory to archive the data before starting the batch run when the patient
result reaches a specific limit (software shows alert message, as required).

Only Patient results will be archived. The Calibration, Control and Consumables
data will always remain in the (Live) Database. While archiving the patient
results, the required additional information such as Area, Location, Doctor,
Reference Range etc are copied to the separate data storage (Archive Database)
and available while reviewing archived results.

This section includes:

Archiving Data

Viewing Archived Data

Observations

6.3.15.1 Archiving Data


Steps to follow the procedure for archive data:

1. Click on the Archive option from the main menu. following screen will be displayed

EM 200
6-220 User Interface

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archive Patient Data option, and click OK,the archive process will start and the
status will be displayed as shown below

EM 200
User Interface 6-221

During the archive process, all other menus will be disabled.

4. After completing the archive process, a message “Archived data successfully” will be
displayed on the screen.

6.3.15.2 Viewing Archived Data


Steps to follow the procedure for Viewing Archive Data:

1. Click on the Archive option from the main menu. Following screen will be displayed.

EM 200
6-222 User Interface

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archived List to View Reports option then select the desired archive to connect
to archive database to view the reports.

4. On clicking OK a message will be displayed “Connection successful. You may view the
Patient Reports”.

EM 200
User Interface 6-223

During this time, only Reports, Search and Shut down menus are available. Rest
of the menus will not be accessible.

5. After connecting to achieve database, user will able to connect to Live database again by
selecting Live record from the list.

6.3.15.3 Observations
When the archive database is connected, the patient data can be viewed only in the following screen:

Reports > Patient Report

Reports > Result Reprint

Reports > Test Statistics

Reports > Error Log

Reports > Reaction Curve

Reports > Other > Reagent Consumption

Search > Patient Results

Other main menu screens are not accessible for the user except the following screens:

Search

EM 200
6-224 User Interface

Reports

Archive

Shutdown

During batch run, the Archive screen will not be accessible.

6.3.16 Shut Down


Shut Down is used to close the MultiXL application. Also, there is an option to perform the automatic
maintenance operation before closing the application.

See the following screen for more details:

Shut Down

Water Save and Shut Down

Maintenance and Shutdown

Before system shutdown, a progress bar may be displayed on the screen which
indicates that the archive operation is in progress.

In this operation, backup of MultiXL database and Log files (XLComLog,


STATUSMSG, ASTMComLog and all xls files) are automatically archived in the
C: drive under MultiXLLog_Backup folder.

It is an automatic operation, which will be performed only after every seven days
when system is shutting down.

6.3.16.1 Shut Down


Use this button to close the MultiXL application. When this button is clicked, the analyzer and PC
will be automatically turned off.

* Only for Analyzer with ISE unit installed.


The analyzer should be kept on as 95 µl of Calibrant-A and 36µl of Calibrant B is
automatically dispensed into the ISE unit every 30 minutes to prevent the
electrodes from drying. Even under the sleep condition, this function is

EM 200
User Interface 6-225

performed.

6.3.16.2 Water Save and Shut Down


On clicking this button, the MultiXL software minimizes and the water save operation is performed.

After completing the Water save activates, it will shutdown the MultiXL application, PC, and Analyzer
automatically.

During the water save operation, if the application software is closed, a


warning message is displayed for confirmation to stop the water save
operation and shut down the software.

This option will be disabled when the analyzer is in hibernate mode


(sleep mode).

On clicking this option, the Status Monitor, Service Check, and


Maintenance screen will be disabled.

6.3.16.3 Maintenance and Shut Down


On clicking this button the auto maintenance activity will be performed and the system will shut down
after completing the operation. The MultiXL software is minimized during the auto maintenance
operation. See Service actions during auto maintenance at Shutdown for more details.

Once the auto maintenance operation is completed, MultiXL software and instrument will
automatically turn off.

This option will be disabled when the analyzer is in hibernate mode (sleep
mode).

During Water Save and Shut Down or Maintenance and Shut Down operation,
the Maintenance screen, Service Check screen, and Status Monitor screen will
be disabled.

6.3.17 Master Calibration


Follow steps as below to perform Master Calibration from card:

1. Go to Monitor > Select Scan Pack > System Pack Details screen will get displayed. Refer
Scan Pack for details.
2. Keep the master calibration card in front of Test loader device and press Scan Pack > following
details will get displayed on the screen:

EM 200
6-226 User Interface

3. Click Register to load master calibration from card.


4. After pressing register "Load Master Calibration Process Completed " message window will
get displayed on the screen.

5. For invalid reagent code, calibration can not be loaded for that code and accordingly message will
get pooped up.
6. User can also load master calibration from Utility > Scan pack
7. After registered the master calibration, go to main screen QC/Calibration > Calibration>
8. Select the test form the test panel for which master calibration is loaded form the card.
9. Master calibration for that test will get displayed with the consumable details on the screen as
shown below;

EM 200
User Interface 6-227

10.Go to main screen> Patients> Master calibration- test will get displayed in test panel grid.

11. Go to Report > Calibration Monitor > Master calibration test will get displayed in the report.

During RUN master calibration from card can not be loaded.

EM 200
Part

VII
Operation 7-2

7 Operation
This section gives you a detailed description of daily workflows and step-by-step information about
common procedures that you need to perform as part of your daily workflow.

The workflow is divided into the following three sections:

Daily start-up

Daily routine

End of day task

Also, this section tells you the basic sequence of operations during the sample analysis. See the
following sections for more details:

Sequence of operations

Measurement operation table

7.1 Sequence of operation


The instrument works on the principle of light photometry combined with the best mechanics for
sampling. The sample under test is sampled into the cuvette, which is then read at defined time
intervals to find out optical densities.

The reaction is read at defined time interval of 18 seconds to obtain their optical densities.

The entire operation can be divided into the following sequence:

1. Getting ready for operation

2. Cuvette rinsing (cleaning)

3. Reagent 1 + Sample addition

4. Stirrer Mixing for R1 + Sample mixture

5. Reading and then reporting

6. Reagent 2 Addition (optional)

7. Stirrer Mixing after R2 addition (optional)

8. Reading and then reporting

9. Removal/empting of bio-hazard reaction waste from the cuvette.

7.2 Measurement operation table


The analyzer records absorbance for a cuvette every 18 seconds over a span of 10 minutes 48
seconds. These readings are used for result calculation. The measurement points are referred to as
M1Start, M1End, M2Start and M2End. Refer section Test Details, point number Assay Points.

Time Cycle Analyzer Action


(Minutes) Number

EM 200
7-3 Operation

0.00 0 Dry the cuvette, Add Reagent 1 + Sample

0.18 1 Stir 1 + Measure reaction mixture absorbance

0.36 2 Measure reaction absorbance

0.54 3 Measure reaction absorbance

1.12 4 Measure reaction absorbance

1.30 5 Measure reaction absorbance

1.48 6 Measure reaction absorbance

2.06 7 Measure reaction absorbance

2.24 8 Measure reaction absorbance

2.42 9 Measure reaction absorbance

3.00 10 Measure reaction absorbance

3.18 11 Measure reaction absorbance

3.36 12 Measure reaction absorbance

3.54 13 Measure reaction absorbance

4.12 14 Measure reaction absorbance

4.30 15 Measure reaction absorbance

4.48 16 Measure reaction absorbance

5.06 17 Add Reagent 2 + Stir 2 + Measure reaction


absorbance

5.24 18 Measure reaction absorbance

5.42 19 Measure reaction absorbance

6.00 20 Measure reaction absorbance

6.18 21 Measure reaction absorbance

6.36 22 Measure reaction absorbance

6.54 23 Measure reaction absorbance

7.12 24 Measure reaction absorbance

7.30 25 Measure reaction absorbance

7.48 26 Measure reaction absorbance

8.06 27 Measure reaction absorbance

8.24 28 Measure reaction absorbance

8.42 29 Measure reaction absorbance

9.00 30 Measure reaction absorbance

EM 200
Operation 7-4

9.18 31 Measure reaction absorbance

9.36 32 Measure reaction absorbance

9.54 33 Measure reaction absorbance

10.12 34 Measure reaction absorbance

10.30 35 Measure reaction absorbance

10.48 36 Measure reaction absorbance + Final result


reporting

11.06 37 Empty cuvette contents + Add detergent

11.24 38 Empty cuvette contents + Add DI Water

11.42 39 Empty cuvette contents + Add DI Water

12.00 40 Empty cuvette contents + Add DI Water

12.18 41 Empty cuvette contents + Add DI Water

12.36 42 Empty cuvette contents + Add DI Water

12.54 43 Measure cuvette blank absorbance

13.12 44 Empty cuvette contents

13.30 45 Drying the cuvette

7.3 Daily start-up


This section tells you the daily start-up procedures which prepare your analyzer for the day.

See the following section for more details:

Verifying system resources

Starting up and logging on to system

Defining required consumables

Defining samples and reagents

7.3.1 Verifying system resources


This section tells you the necessary verification of resources to be performed daily before starting the
instrument for analysis.

System Water Can and Waste Can

Confirm that:

The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.

Bio-hazardous Waste Can should be emptied.

Cleaning Solution Can

EM 200
7-5 Operation

1. The cleaning wash solution should be filled with sufficient wash solution.

Preparation of Cleaning Solution

1. Fill the cleaning solution can (given with the Accessories List) with 20 liter of DI water.

2. Pour the 200 ml concentrated solution into the can to prepare a 1% detergent solution.

3. Mix it well before use.

ISE Unit (Optional)

Ensure that the following checks are performed before ISE measurement:

Before performing measurement with the ISE unit, confirm that Electrode unit (Na, K, Cl, Li and
Reference electrodes) whose term of validity is not expired is installed.

The Reagent Pack is filled with sufficient Calibrant-A and Calibrant-B solution.

Cleaning was carried out at the end of the last ISE measurement.

The Calibrant-A is flowing from the side of sample port by executing of ISE purge.

In the following cases, ISE purge should be carried out 5 times or more:

At the first measurement of ISE.

At the time of exchanging the ISE Reagent pack.

At the time of being pulled up the tube from the Calibrant-A.

The main switch of the analyzer should be kept ON because 95 µl of


Calibrant-A and 36 µl of Calibrant-B is automatically dispensed into the ISE
unit every 30 minutes to prevent the electrodes from drying.

Just after turning on the analyzer, 3-4 times of ISE purge should be carried out. All electrodes
should be fitted to the ISE module, otherwise the liquid of Calibrant-A is flooded into the inside of
analyzer. It may cause serious problem.

Preparation of Tank Solution

The external tanks of the system DI water, detergent, bio-hazardous waste and diluted waste are
to be placed near the right-hand side or rear side of the analyzer and to be connected to the
analyzer with the corresponding tubes which includes float sensors.

Just before measurement, the external tanks of the system DI water and cleaning solution are
filled with the corresponding liquid, and the tanks of the bio-hazardous waste and diluted waste
have to be empty.

De-ionized Water

Detergent solution

Bio-hazard (Concentrated) Waste

Diluted Waste

EM 200
Operation 7-6

The DI water should have a resistivity of more than 1 Mega Ohm-cm (or conductivity less than
1µS/cm). Also the pH of the DI Water should be maintained to 5.0 to 7.0.

7.3.2 Starting up and logging on to the system


Follow this procedure for starting the analyzer

1. Perform the following verification before starting the equipment.

Make sure that tube connections with Bio-hazardous waste Can, Cleaning Can, DI
Water Can and Waste Can are properly done.

Make sure that tray lids or covers are properly placed on Sample Tray, RCT, and
Reagent Tray.

2. Once the verification is done, turn on the main power supply switch.

Before starting the main supply, make sure that the Main ON/OFF
switch and secondary switch provided on the left and right side of the
analyzer should be in OFF condition.

3. Turn on the primary switch that is provided on the back side of the analyzer.

When this button is on, the ISE unit will be started (if installed on the
instrument).

Verify and confirm that all ISE electrodes have been properly
installed; their walls are flush against each other with the rubber “O”
rings in place if analyzer is equipped with ISE.

Verify and confirm that the reagent cooling fan has started rotating,
also touch and physically verify the cooling of the reagent tray, also
verify from the sound, that the ISE pumps have started priming.

4. Turn on the secondary switch provided on the right side of the analyzer. After turning on the
switch, all the assemblies initialize to its home position.

This will initializes the system, and all assemblies will come to home position. Now the
instrument is powered-ON, and ready.

5. Turn on the PC.

The MultiXL software will start automatically and the login screen is displayed.

6. Enter the login details and click OK.

You now have access to the system, depending on your user access level.

If the analyzer is already ON, the system goes through a series of automatic service
maintenance actions. Typically, these actions are performed before the work day begins,
so that the instrument is ready to use when you start work. No user action is required in
this process. See section Auto Maintenance for more details.

The maintenance actions can be performed any time through Maintenance screen.

EM 200
7-7 Operation

7. Now the instrument is ready for further run.

The main power switch should be on at all times except in an


emergency. The main power supplies electricity to ISE unit for automatic
priming of ISE .

7.3.3 Defining required consumables


Before placing the reagents and sample for analysis, define required consumables through
Consumable screen.

See Consumable screen for more details.

7.3.4 Preparing Samples and Reagents


Before starting the analysis, the patient samples and reagents must be dispensed in the containers
and placed in the sample and reagent tray.

Conditions for the Sample Containers

Multiple container sizes can be used in sample tray.

The Dead Volume probe stroke must be set appropriately for the range of
tubes in use.

The operator must ensure that the sample is present in the sample container.
If the dead volume is not set appropriately for all types of containers then
incorrect sampling from that container will happen.

Use the following containers in sample tray:

10 ml Tube (16 mm x 100 mm)

7 ml Tube (14.5 mm x 84 mm)

5 ml Tube (13 mm x 75 mm)

2 ml Sample Cup

Instruction

Check that there is sufficient serum for analysis in the primary tube, in addition to the dead
volume required for sample detection. The dead volume required for sample detection varies
depending on the sample container type. If the serum height in the sample container is less than
the limit, transfer the serum into a smaller container and then start the analysis. Otherwise, when
the blood cells under the serum in the container are aspirated, analysis and dispense
abnormalities could occur.

Specification of Barcode Label

Item Description

EM 200
Operation 7-8

Symbols NW-7, Code39, ITF, UPC, Code128 (Set A, B, C)

Maximum Number of Digits The bar codes must be in conformity with one of the following
bar modules and with bar code printing range.
The maximum allowable number of digits varies depending on
symbols.
NW-7: 6 to 18 digits
Code39: 6 to 18 digits
ITF: 6 to 18 digits
UPC: 6 to 18 digits
Code128 SetA : 6 to 18 digits
Code128 SetB : 6 to 18 digits
Code128 SetC : 6 to 18 digits

Bar module Fine bar: 0.25 to 1.0 mm

Barcode printing
Range

Printing Black on white background (B633) Numeric coding


information is printed beside bar code. Printing on thermal
paper is not allowed in order to prevent bar code from time
varying degradation.

Positioning of barcode label The position is such that there is no obstacle between the
barcode printing area and the bar code reader.

Applying Barcode Labels to the Sample Containers

1. Place the barcode labels onto the sample containers so that they meet the following
conditions:

2. The lowest bar of the barcode label should be 15 mm (+/- 2 mm) above from the bottom of
the sample container. If the label is applied below this position, the reader may not read the
Sample Barcode.

3. The Highest bar of the barcode label should not be beyond 59 mm (+/- 2 mm) from the

EM 200
7-9 Operation

bottom of the sample container. If the label is applied beyond this position, the reader may
not read the Sample Barcode.

4. Make sure that the entire surface adheres to the tube properly.

5. The barcode label should not rise above the top of the tube.

Barcode Placement on Reagent Bottles

Necessary reagents and wash solutions for analysis are placed on the reagent tray.

Applying bar code labels to the reagent bottles:

Place the barcode label on the Flat side of the Reagent bottle so that they meet the following
conditions:

The lowest bar of the barcode label should be 18 mm (+/- 2 mm) above from the bottom of
the reagent bottle. If the label is applied below this position, the reader may not read the
Barcode.

The Top most Bar of the barcode code label should not be beyond 81 mm (+/- 2 mm) from
the bottom of the reagent bottle. If the label is applied above this position, the reader may
not read the Barcode.

Place the label so that it is parallel with the sides of the bottle.

Make sure that the entire surface adheres to the reagent bottle.

The barcode label should not rise above the top of the bottle.

7.3.5 Defining samples and reagents


Before starting the analysis, the patient samples and respective reagents must be dispensed in the
containers and placed in the trays.

Refer section Preparing Samples and Reagents for more details.

Following sections will show you how to defnin sample and reagents through MultiXL.

Defining Samples

Defining Reagents

EM 200
Operation 7-10

7.3.5.1 Defining Samples


Samples can be barcoded or non-barcoded. Follow the appropriate procedure for defining samples.

Refer section:

Barcoded

Non-Barcoded

7.3.5.1.1 Barcoded

Use the following steps to define the barcoded sample:

1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).

2. Go to Patient Entry screen, and enter the following necessary details.

a. Enter the Sample ID.

a. Select the Barcoded option (if sample tube is barcoded).

For emergency samples, select Emergency option, if required.

b. Enter the group number in Group text-box, if required.

c. Enter other details for the patient, as required:

Sample Type
Sample Vol Type
Area
Ref Doctor
Sample Remark
Container Type
Collection Date
Reg. Date
Sample Replicates
Analyst
Patient Name
Age
Category
Patient ID
Address (of Patient)
Telephone
Patient and Sample Remarks
Select required tests, calculated items and profiles from Tests grid.

3. Click on SAVE.

4. This will save the programmed patient details and presents a new screen for programming
the next patient where the sample ID and sample positions are automatically incremented
if option Barcode is unchecked.

5. Use EDIT button, to edit or modify the already entered details.

6. Open Utility > Reagent Position screen, and define the necessary reagents required for
the test.

EM 200
7-11 Operation

7.3.5.1.2 Non-Barcoded

Use the following steps to define the barcoded sample:

1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).

2. Go to Patient Entry screen, and enter the following necessary details.

a. Enter the Sample ID.

b. Un-check the Barcoded option.

c. Enter the sample tube position number in the Position text-box.

For emergency samples, select Emergency option, if required.

a. Enter the group number in Group text-box, if required.

b. Enter other details for the patient, as required:

Sample Type
Sample Vol Type
Area
Ref Doctor
Sample Remark
Container Type
Collection Date
Reg. Date
Sample Replicates
Analyst
Patient Name
Age
Category
Patient ID
Address (of Patient)
Telephone
Patient and Sample Remarks
Select required tests, calculated items and profiles from Tests grid.

3. Click on SAVE.

4. This will save the programmed patient details and presents a new screen for programming the
next patient where the sample ID and sample positions are automatically incremented if option
Barcode is unchecked.

5. Use EDIT button, to edit or modify the already entered details..

6. Open Utility > Reagent Position screen, and define the necessary reagents required for the
test.

7.3.5.2 Defining Reagents


Before doing the analysis, place the necessary reagent and wash solution on the reagent tray.

Stick the barcode labels on the flat side of the reagent bottles and perform barcode scan operation
through Status Monitor. See section Barcode Scan for more details.

The analyzer will scan the reagent bottles and automatically detects and save the details (like

EM 200
Operation 7-12

Reagent position number, lot number, Expiry date etc) related to the reagents placed in the reagent
bottles. Those details are saved and can be viewable on Status Monitor and Reagent Position
screen.

If the reagents are not having the lot details, it can be defined through the Consumable screen.

Condensation can take place on the walls of the reagent tray, near the reagent
bottle neck or on the barcode label due to the reagent cooling mechanism. If
condensation is present, then remove it using a dry tissue/paper.

To Add a new Reagent

In the closed system, user is allowed to define or add only permitted


number of open channel reagents (user defined), after that system
will prompt a message.

1. In the Consumable screen, select the Consumable Type to Reagents.

2. Now click on the button next to the Consumable box.

3. On clicking, the following screen will be displayed.

4. Enter the Reagent name, Reagent Code, and Reagent Type.

5. Click SAVE to save the details.

6. The following are the description of the parameters on the screen.

Reagent Enter the name of the reagent.


Reagent Code Enter the unique Test Code.
This is the 4th and 5th digit on the Reagent Barcode Label on
the bottle. It is used to identify the Reagent and update reagent

EM 200
7-13 Operation

position after Reagent Barcode scan.

For closed channel reagents, reagent code should be a unique


2-digit number in permitted range.

For open channel reagents, reagent code should be a unique


3-digit number in permitted range.
Reagent Type Select whether the reagent is single reagent or dual reagent.
The available options are:
R1
R1, R2

In the closed system, user is allowed to define or add reagent code


only in the permitted range, otherwise system will prompt a
message.

7. The following are the description of the buttons on the screen.

PRINT This button is used to print the list of reagents.


SAVE This button is used to save the reagent details.
EDIT This button is used to edit the details of the selected
reagent.
CLEAR This button is used to cancel add / edit mode.
DELETE This button is used to delete the reagent (till not used
either in batch run or Test Parameters).

Default loaded Erba reagents can not be deleted.

8. On saving the details, the reagent will be added in the list of reagents as shown in the
following figure.

EM 200
Operation 7-14

To Add lot details for a Reagent

1. Double click on the Reagent name, to select from the list of reagents.

2. The selected Reagent will be displayed in the Consumable screen.

3. Click on the ADD button.

4. On clicking, the following window will be displayed.

EM 200
7-15 Operation

5. Now enter the manufacturer name from the Manufacturer drop down list. See section
Master – Manufacturer for adding manufacturer name in the list.

6. Enter the lot number in the Lot No text box.

7. Enter the expiry date of the reagent in the Expiry Date list.

8. Enter the onboard stability and unit in Onboard Stability text-box and Unit drop down list.

9. The Reagent Type check-boxes will be pre-selected. It is defined while entering the
details for new reagent..

10.Once the above details are entered, click on SAVE to save these details.

11.The reagent will be added and displayed on the grid.

EM 200
Operation 7-16

To Edit Details for a Reagent

1. To edit the reagent details, go to Consumable screen, select the Consumable Type as

Reagents and click on the button.

2. On clicking, the following screen will be displayed.

EM 200
7-17 Operation

3. Double click on the desired reagent name from the list of reagents.

4. Click EDIT button.

5. On clicking, the following screen will be displayed for editing the details.

6. Edit the appropriate details and click SAVE.

7. On clicking, the details will be saved.

8. Following table gives a brief explanation on the different parameters in the grid.

Parameters Description
Manufacturer Select the Reagent Manufacturer from the drop-down list.
A Manufacturer from Master > Mfg screen.
Stock Over Check this Stock Over box when the stock of the consumable
lot is completely utilized.
Lots marked as Stock Over will not appear in the Lot
.
Selection List -

While defining Reagent Positions in the Utility > Reagent


Position screen

While scheduling Calibration and Controls from QC/


Calibration > Schedule QC / Calibration screen.

Note: In case, Stock Over is not ticked for a Lot; then the Lot
will be excluded from the selection list after its expiry date.
This checkbox is available only in Edit mode and not while
adding a Lot.

EM 200
Operation 7-18

Lot No Enter the lot number of the reagent.


Lot Status Lot status as Active or Inactive is displayed based on the
Expiry Date defined for the Lot. Expired Lot is displayed as
Inactive.
Expiry Date Select the expiry date of the Reagent lot.
On-board Enter the On-board shelf life of the reagent.
Stability
Unit Select the On-board Stability unit, as appropriate.
Options available are Hours and Days.

Reagent Type Select whether R1 and/or R2 is received for the selected Lot
number.
In case, lot numbers are different for R1 and R2, then define
both the Lots for R1 and R2 appropriately.

Lot details can be edited directly by double-clicking on the required


lot from the main Consumable Screen.

Reagents can be barcoded or non-barcoded. Follow the appropriate procedure for defining samples
through MultiXL software.

Refer section:

Barcoded

Non-barcoded

7.3.5.2.1 Barcoded

Reagent Barcode scan identifies the reagents and updates the positions of the Barcoded Reagent
bottles placed on the reagent tray.

Steps to register barcoded reagent bottles are as follows:

1. Place the barcoded reagent bottles on the Reagent Tray.

2. Go to Status Monitor > BARCODE SCAN screen.

3. Click on Reagent Barcode Scan button.

On clicking, the available reagents will be scanned and the barcode information is
registered and displayed on the screen.

EM 200
7-19 Operation

Column S.N. represents the Position number in the Tray.

Column Reagent Barcode generally shows the barcode number read from bottle.

In some cases, instead of barcode number, following content may be displayed in this
column.

“Checksum Mismatch”: When the checksum digit does not match the calculated
checksum of the bar-code digits.

“Unknown-barcode”: When the digits read are not as per required format or less than
18 digits are read.

“RGT Code Unknown“: When the Reagent Code is not found in the list of Reagents in
Consumables screen.

“-“: Reagent position is manually defined through Utility > Reagent Position screen.

Reagent(s), their position, Lot number and Expiry date is registered in the system for the
barcoded bottles.

Reagent is identified from the Reagent code mentioned in the barcode pattern and matching
this Reagent Code with the Reagent Code mentioned in the list of reagents in the
Consumables screen.

This updated information is available in the Utility > Reagent Position screen.

Lot number is added in the list of Reagent Lots in Consumables screen.

The Reagent Barcode Scan button will be disabled if the option Sample

EM 200
Operation 7-20

Barcode is unchecked in Settings > System Parameters screen.

4. Alternatively, a batch run can be started with Reagent Barcode scan as a predecessor as
follows.

Select (tick) Reagent Barcode Scan option from the Pre-Run Options (at the top right
hand corner) in Status Monitor > SAMPLE TRAY screen. Click on start (batch) run
button.

Reagent trays will be (barcode) scanned first and barcode information is updated
automatically in the system (refer to point 5 above for details), before starting the batch
run.

Batch run will start only if the reagent positions are available / known for all the test(s)
scheduled in the selected group.

After the scan is over, other details (like Reagent position number, Reagent name,
Reagent type… etc) are updated in the Utility > Reagent Position screen. For example:
See the following screen.
7.3.5.2.2 Non-Barcoded

In Test Loader System, Barcoded reagent bottles will be identified only if


reagent pack is scanned.

In Test Loader System, reagent bottles will be identified by barcode scan


and only permitted number of open channel reagents (user defined) are
allowed to define manually.

Reagent details will be scanned and displayed in Utility > Reagent Position
during pre-run operations or Volume Scan.

Reagent positions for non-barcoded bottles are manually defined through Reagent Position screen as
follows:

Steps to register non-barcoded reagent bottles are as follows:

1. Place reagent bottle in appropriate position on the Reagent tray.

2. Go to Utility > Reagent Position screen.

3. Select Edit Position check-box. See the following figure.

EM 200
7-21 Operation

4. Select the required position to be defined, from the Position list or select the required position
from the screen.

5. Select the reagents name from the Reagent list.

6. Select reagent type (R1/R2) from the Reagent Type list.

7. Select the appropriate bottle type from the Bottle Type list.

8. Select the reagent available lot number from the Lot No. list (Optional).

9. Click on Save Position Detail.

On clicking, reagent details will be saved to the selected position and displayed in the
positions grid on the screen.

EM 200
Operation 7-22

The Rgt Vol (ml) column will show 0.00 ml at the time of definition, and it
will be updated after Reagent Volume Scan or at the first aspiration during
run.

7.4 Daily routine


This section tell you daily routine procedure which keep your system running for the routine work.

See the following section for more details:

Starting analysis

Interruption and resumption of measurement

User activities during run

Self activities during run

End of day task

7.4.1 Starting analysis


Once the samples, reagents and necessary consumable are scheduled, you can start the run.

1. Go to Status Monitor > SAMPLE TRAY.

2. To start the run (measurement), select the group no. and click on start arrow button,
provided on screen.

EM 200
7-23 Operation

In closed system, batch run will not be started, if user defined open
channels are more than the permitted limit.

When click on button, a card expiry warning message will get


displayed with expiry details of open test counts if card is expiring soon.
Click to close the warning message.

When starting the batch RUN ,if dome is open ( Level 1 and Level 2 ) then pre
run activities will not be started and error message will be displayed in error
display grid.

Ensure to close dome properly before proceeding

During pre RUN activities, if dome is open ( Level 2 ) then all activities which
required ARM movement will be stopped immediately ,alarm and error will be
reported in error display grid. Also further sampling will be paused.

3. Before starting the run, it is recommended to close all other running application from the
computer as it may effect the execution of programmed tests. The following warning message
will be displayed along with the list of application, if any other application is running in
background.

Clicking on Yes will continue the run and No will stop the run.

EM 200
Operation 7-24

4. On start of the batch run, firstly RCT and RGT temperature is checked and the status will be
displayed on the screen.

Secondly, Auto span is performed, if auto span operation fails, again run is stopped (Run will
be stopped only if all wavelengths are out of range).

In case, if auto span operation fails for any wavelengths, user can continue the run with other
remaining wavelengths which are measured as in proper range. For user indication, a
message “Lamp / Optics Value Out Of range for …..” will be displayed with defective
wavelengths and all tests related to those particular wavelengths will be masked and can not
be rescheduled during the same run.

After this, ISE calibration will be performed in which the calibration values for each electrode
(Na, K, Cl, Li) are checked. If the values are in range, the run will proceed. ISE Calibration
fails if the values are not in range. In such case, system performs further action, as defined
by user in System Parameter screen.

Refer description given for parameter Action On ISE Calibration Failed in section System
Parameters.

ISE calibration, if not already performed for the day, is performed


automatically before starting the batch run. However, user can manually
initiate ISE Calibration any time through Maintenance screen, when run is
not in progress.

ISE calibration will be performed automatically before starting batch run,


only if the option ISE Patient is selected under RUN OPTIONS.

If ISE calibration values obtained are not in range then system re-attempts
calibration, maximum up to 3 times.

Also, if there are any errors occurred on initialization of the instrument then the run is halted.

5. After performing pre-run operation successfully, the batch run will be started.

In case, if insufficient volume details or incomplete test details are detected, during pre-run
operations, the work list screen will be displayed and the run is halted.

In this case, the corresponding tests will be masked and moved into the Pending and Mask
test list. Also, it will display the total number of possible tests (approximate) with the
available reagent volume. See Work List screen for more details.

Make sure that Wash solution and Diluents are available on the tray
before starting the run; otherwise sampling will not continue which is
indicated by a warning message on the screen.

9. Start time of the run is displayed at top left corner of the screen.

During run, the progress of the measurement is displayed at the right hand side of the
screen.

EM 200
7-25 Operation

10.Results are displayed in the result grid and errors if any are displayed in status message grid
at the bottom of the screen.

7.4.2 Interruption and resumption of mesurment


During run, due to occurrence of some critical errors the run may be stopped in between or paused
temporarily/permanently.

During run, the sample processing can be interrupted and resumed manually, if required.

Following button are provided on the Status Monitor > Sample Tray screen :

Use button to stop the run immediately. On clicking, all the assemblies initialize.

Use button to pause the sampling. If it is clicked, the processed result will be given out
and displayed on the result grid.

Use button to continue the sampling.

On resuming batch run or when the run is completed, a beep will be sounded
by the analyzer.

EM 200
Operation 7-26

7.4.3 User activities during run


User can do the following activities when the run is in progress:

Checking online reaction curve

During run, the user can monitor the online reaction curve for the test. See section Reaction Curve
for more details.

Re-scheduling pending and mask tests during run

During run, pending tests / mask tests can be re-schedule by clicking on the free space near the
sample positions. On clicking, the WorkList screen is again displayed, using which the tests can
be selected and then RE-SCHEDULE button can be clicked. (Pending / Mask tests can be
scheduled only if the reagent and test details are available). See section Work List for more
details.

Patient sample entry

During run, emergency patients can be added from the Patient Entry screen by selecting the
option of ‘Emergency’ for that particular patient, entering the sample details and patient details.

During run, normal patients can be added from the Patient Entry screen, entering the sample
details and patient details.

Adding barcoded sample and reagent during run

Refer section Add Sample and Reagent for more details.

Non barcoded reagent entry

During run, non-barcode reagents can be added from Reagent Position screen on empty reagent
positions. See section Defining non barcoded reagent bottles for more details.

7.4.4 Self activities during run


This section tell you about the self activities which may performed during the run by system.

Progress of the measurement

During run, progress of the measurement is displayed at the right hand side of the screen.

Following are the list of messages may be displayed during the run in the TEST column. The
message indicates that the cycle has skipped due to following reason:

Message Reason

DLUN Dilution schedule

CELBK Dirty cuvette

PAUSE Pause due to error user pause

SKIP Cuvette skipped due to carry over or


Any test requiring special wash solution for the cuvette.

ISE-S Serum ISE cycle schedule

EM 200
7-27 Operation

ISE-U Urine ISE cycle schedule

ISE-Skip Cuvette skipped due to dilution for urine ISE schedule

WASH Skip due to wash cycle

COP Cycle skip due to forbidden carry over pair

SWS Special wash

NSWS Special wash absent

Stirrer wash (STRWS) will be performed in the following situations:

During machine initialization process.

During batch run, when all the test schedules are performed and then
next 10 cycles there is no test schedules are remaining, on 11th cycle,
stirrer wash will be performed for R1 and R2.

When reagents defined on multiple positions

In case, there are multiple reagent positions defined for a test:

During run, the reagent will be aspirated from the reagent (bottle) position having the
nearest expiry date.

In case of multiple reagent bottles having the same expiry date, the reagent will be
aspirated in the order of position.

After the completion of the first batch run, the position of the last sensed in used
reagent bottle will be memorized. On starting the next batch, the previously sensed
reagent bottle position will be used for aspiration.

In case of multiple reagent positions, when volume of the first reagent reaches near dead
volume, then it will automatically switch over to next available reagent for the same test. If
reagent level scan is not done, then it will take previously sensed volume into consideration
while switching to next available reagent position.

In case of last available reagent bottle, if sampling continues till the reagent is absent, then the
remaining schedule of the test will be added in the pending list. In this case, user needs to add
new reagent bottles through Add Reagent button. See section Add Sample and Reagent.

In closed system, during run, reagent bottle will get discarded after
consuming factory filled reagent volume.

Low reagent volume message

During run or after reagent volume scan, when the number of possible tests for a particular reagent
is less than equals to specified tests in Warn After option in Test Parameter screen, then a low
reagent volume message will be displayed in error message grid. See Warn After option for more
details.

EM 200
Operation 7-28

Auto wash reminder

Reminder for auto wash will be displayed on the Status Monitor screen after the end of first batch
run of the day if the user has not performed auto wash for 7 days. Refer command Auto Wash in
section Wash for more information.

When froth is sensed

During run, when the froth is sensed in R1/R2/R3 reagents, following actions can be performed:

When froth is sensed while first reagent aspiration, then that test will move to pending list.

If froth is sensed in three consecutive reagent aspirations, then that reagent bottle position
will be deactivated and the associated test will move to pending list.

In case if reagent position gets deactivated, the reagent will be aspirated


from the next available position, if multiple reagent positions are available
for that test.

Use Refresh Position button to reschedule the reagent bottle positions, which
are deactivated during run. See Refresh Positions for more details.

Schedules

During run, schedule will be sent as follows:

Blank, Standard, Calibrator, and Control – Test-wise, according to test process


sequence defined in Settings > Test Sequence option

Patient Samples will be performed as follows:

Emergency patient samples will be performed at highest priority. All emergency patient
samples defined before starting the run will be performed in the order of Sample
position number. Emergency samples defined during run will be performed on first-in-
first-out basis.

Then non-emergency Patient Samples will be performed in the order of Sample position
number. However, samples defined during run will be performed on first-in-first-out
basis.

If control interval is defined, control schedules will be sent between patient samples
according to the control interval defined in Test Parameters screen.

Auto error recovery

See section Error Handling for more details.

During processing of ISE tests

During the processing of ISE tests,

EM 200
7-29 Operation

ISE tests sampling will be stopped (for the current batch) on the occurrence of error “Air in
Cal A/B”, "No Flow" and "ISE Time Out" consecutive two times.

During calibration run of linear curves

During calibration run of Linear Curves, if the calibration factor is differed by specified limit, a
message will be notified on the QC/Calibration > Calibration screen about the calibration out of
range for the test. Refer Acceptable Limit% in section Calibration for more details.

7.5 End of day task


This section tell you end of day procedure which prepares your analyzer for next day.

To shut down the system:

1. Perform any necessary end-of-day tasks such as maintenance operations.

2. After completion of the tasks, click on Shutdown.

3. Choose the appropriate option from the shutdown screen. See section Shutdown for more
details.

Once you initiate a shutdown, you cannot use the system.

The instrument is designed to run continuously, so there is no need to switch


it off every day, unless that is a requirement in your laboratory.

EM 200
Part

VIII
8-2 Error Handling

8 Error Handling
All the mechanical movements are controlled and monitored by the computer. When a problem
arises, the computer becomes aware of it and generates the visual error message to call the
operator's attention.

In the event of the problem that may affect the performance of the analyzer, the sampling stop or
emergency stop will be executed. In the case of sampling stop mode, the analyzer carries on and
completes the processing of the sample that is not affected by the problem. In the case of problem
that may affect the entire measurements of sample, the emergency stop will be executed.

Error recovery is an ability of software or equipment in which the errors will be automatically
recovered without affecting the sample run. During run, when the error is encountered, system will
first identify whether the current error falls under error recovery category or not. If yes, then the
system will initiate the recovery for that particular error, without run pause. The test affected due to
this error shall be moved to pending and auto rescheduled (if Auto Resch option is selected). In
case, if error is not recovered, then depending upon the severity of the error the run will be stopped or
paused. Possible errors which comes under auto error recovery category are listed in section List of
errors.

Error Log screen will displays all the errors occurred on the analyzer during the test run or service
check operation. This data is generally useful for servicing/diagnostic purposes.

Problem may arise, which is not monitored by the computer. Any alarm message may not be
indicated on the display for such a problem. Such a problem includes abrasion of parts, leakage in
the sampling system, etc. When this type of problem occurs, decide whether the processing of
sample is carried on or the measurement is terminated, considering that such problem may result in
damage to the analyzer or erroneous outcome of measurements.

When user clicks on Start Run button on Status Monitor, if any error is detected
during initialization of the instrument then the error message will be displayed in
the error grid on the Screen. In such case, the instruments will stop. The user has
to take the corrective action.

See the following sections for more details:

Flag list

List of errors

8.1 List of Errors


Assembl Error Flags Error Possible Corrective Action to Auto
y Code Descripti Failure be Taken Error
on Recovery
and
Resched
ule?
Arm 11 @R1 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Trough to sure that nothing is
Reagent 1 obstructing Arm
position rotation.

EM 200
Error Handling 8-3

2. Interface 2. Then switch ON the


board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent inner>
Execute commands.
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer.
and its
connection
Arm 12 @R1 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Reagent 1 sure that nothing is
position to obstructing Arm
Trough rotation.
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent inner>
<Reagent outer/inner
to trough> Execute
commands.
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer.
and its
connection
4. If the initialization or
VOD generation fails,
call the Service
Engineer.
Arm 13 Arm VOD 1. VOD Opto 1. Check the arm No
error Sensor alignment in [Service
Check]. If it is hitting at
the edge, then align
the probe using the
calibration facility.
(During 2. The 2. Remove the cover of
service connectors the arm and check and
check) clean the VOD opto.
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during button. Push the probe
Reagent 1 gently to cut the VOD
operation opto so as to generate

EM 200
8-4 Error Handling

a VOD Error will be


generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 14 @R1 Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move SPT
Trough position arm up and down by
during optos, up/ hand and make sure
reagent 1 down optos that nothing is
operation and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down 4 . If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connections
Arm 15 @R1 Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Reagent 1 optos instrument. Check if
position the error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer

EM 200
Error Handling 8-5

Arm 16 @R1 Arm Up 1. Arm VOD 1. Switch OFF the Yes


error - opto, arm analyzer; Move SPT
Reagent 1 position arm up and down by
position optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down 4. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connections
Arm 17 Arm 1. Arm 1. Switch OFF the No
rotation position Opto analyzer; Rotate arm
error signal by hand and make
sure that nothing is
obstructing Arm
rotation
(During 2. Interface 2. Then switch ON the
service board and its instrument; Go to
check) connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 18 Arm up/ 1. Arm VOD 1. Switch OFF the No
down error opto, arm analyzer; Move arm up
(During position and down by hand and
service optos, up/ make sure that nothing

EM 200
8-6 Error Handling

check) down optos is obstructing Arm


and rotation movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute
<Arm Up> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 19 @R1 Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Trough optos instrument. Check if
during the error comes again
reagent 1
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 1A !R1 Arm VOD 1. VOD Opto 1. Check the arm If same
error - Sensor alignment in [Service reagent is
Reagent Check]. If it is hitting at present in
Pos. the edge, then align next
the probe using the available
calibrate facility. position
then
associate
d tests
get auto
reschedul
ed else it
will move
to

EM 200
Error Handling 8-7

2. The 2. Remove the cover of pending


connectors the arm and check and list. It can
clean VOD opto reschedul
ed using
3. Arm 3. Go to Service
Refresh
position in Check: Arm Menu.
Position
Reagent tray Click on <Initialize>
button.
at R1 position button. Push the probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 1A !D Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Diluent Check]. If it is hitting at
Pos. the edge, then align
the probe using the
calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Arm 3. Go to Service
position in Check: Arm Menu.
Reagent tray Click on <Initialize>
at Diluent button. Push the probe
position gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 1B/ R1** R1 Liquid 1. Liquid Level 1. Call the Service No
LLD Level Detector Engineer
found
different at
Pos.
2. Actual 2. Physically check
liquid level the liquid in the
may be reagent bottle
different from
the previous
liquid level
Arm 1C !R1! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align
Reagent 1 the probe using the
operation calibrate facility.

EM 200
8-8 Error Handling

2. The 2. Remove the cover of


connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during button. Push the probe
Reagent 1 gently to cut the VOD
operation opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 1C !D! Arm VOD 1. VOD Opto 1. Check the arm No
error – Sensor alignment in [Service
Dilution Check]. If it is hitting at
pos. the edge, then align
the probe using the
calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during button. Push the probe
Reagent 1 gently to cut the VOD
operation opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 1D/1D R1* Reagent 1 1. Reagent is 1. Place the reagent at No
* absent - not kept in the the required reagent
Pos. reagent bottle position
or reagent
bottle not kept
at the defined
position
2. Reagent is 2. Check the level of
below the Reagent and ensure
Dead volume that it is above the
Dead volume
3. Arm 3. Call Service
position in Engineer
reagent tray

EM 200
Error Handling 8-9

4. LLS circuit
and its
connector
problem
Arm 1D/1D D* Diluent 1. Reagent is 1. Place the reagent at No
* absent - not kept in the the required reagent
Pos. reagent bottle position
or reagent
bottle not kept
at the defined
position
2. Reagent is 2. Check the level of
below the Reagent and ensure
Dead volume that it is above the
Dead volume
3. Arm 3. Call Service
position in Engineer
reagent tray
4. LLS circuit
and its
connector
problem
Arm 1E @R1 Arm 1. Sample 1. Switch OFF the No
Initialize position Opto analyzer; Rotate arm
Rotational signal by hand and make
error sure that nothing is
obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
command
3. Up/Down 3. If the initialization
and rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 1F @R1 Arm 1. Arm VOD 1. Switch OFF the No
Initialize opto, arm analyzer; Move SPT
Up/Down position arm up and down by
error optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute

EM 200
8-10 Error Handling

commands

3. Interface 3. If the initialization or


card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm BB !S Arm VOD 1. Arm VOD 1. Switch OFF and No
error at opto, arm then switch ON the
ISE unit position instrument. Check if
optos, up/ the error comes again
down optos
and rotation
optos
2. Probe 2. Remove the cover of
assembly the sample arm and
check and clean
obstacle opto
3. Interface 3. Check the Arm
card and its assembly
connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 21 @R2 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Trough to sure that nothing is
Reagent 2 obstructing Arm
position rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 22 @R2 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Reagent 2 sure that nothing is

EM 200
Error Handling 8-11

position to obstructing Arm


R2 rotation
Cuvette
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute <Reagent
outer/inner to R2
cuvette> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 23 @R2 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - R2 signal by hand and make
Cuvette to sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute <Reagent
outer/inner to R2
cuvette> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 24 @R2 Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move SPT
Trough position arm up and down by
during optos, up/ hand and make sure
Reagent 2 down optos that nothing is
operation and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in

EM 200
8-12 Error Handling

Trough> Execute
commands

3. Interface 3. If the initialization or


card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 25 @R2 Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Reagent 2 optos instrument. Check if
position the error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 26 @R2 Arm Up 1.ARM up/ 1. Switch OFF the Yes
error - down opto, analyzer; Move SPT
Reagent 2 ARM position arm up and down by
position opto, ARM hand and make sure
Home opto, that nothing is
ARM direction obstructing SPT
opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer

EM 200
Error Handling 8-13

4. Up/down
and rotation
stepper motor
and its
connections
Arm 27 @R2 Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Cuvette optos instrument. Check if
during the error comes again
Reagent 2
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 28 @R2 Arm Up 1. Arm VOD 1. Switch OFF the No
error - R2 opto, arm analyzer; Move SPT
Cuvette position arm up and down by
optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Trough to R2
cuvette> Execute
<Arm Down> Execute
<Arm Up> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections

EM 200
8-14 Error Handling

Arm 29 @R2 Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Trough optos instrument. Check if
during the error comes again
Reagent 2
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 2A !R2 Arm VOD 1. VOD Opto 1. Check the arm No
error – Sensor alignment in [Service
Reagent Check]. If it is hitting at
Pos. the edge, then align
the probe using the
calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Reagent Click on <Initialize>
tray at R2 button. Push the probe
position gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 2B R2! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Cuvette Check]. If it is hitting at
during the edge, then align
Reagent 2 the probe using the
operation calibration facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Cuvette Click on <Initialize>

EM 200
Error Handling 8-15

during button. Push the probe


Reagent 2 gently to cut the VOD
operation opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 2C !R2! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align
Reagent 2 the probe using the
operation calibration facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during button. Push the probe
Reagent 2 gently to cut the VOD
operation opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 2D/2D R2* Reagent 1. Reagent is 1. Place the reagent at If same
* absent – not kept in the the required reagent reagent is
Pos. reagent bottle position present in
or reagent the next
bottle not kept available
at the defined position,
position then the
associate
2. Reagent is 2. Check the level of
d tests
below the Reagent and ensure
get auto
Dead volume that it is above the
reschedul
Dead volume
ed else it
3. Arm 3. Call Service will move
position in Engineer to
reagent tray pending
list. It can
4. LLS circuit
reschedul
and its
ed using
connector
Refresh
problem
Position
button.

EM 200
8-16 Error Handling

Arm 2E R2** R2 Liquid 1. Liquid Level Call the Service No


Level Detector Engineer
found
different at
Pos.
Arm 1F/2F @R2 Arm 1. Arm VOD 1. Switch OFF the No
/ Rotational opto, arm analyzer; Move SPT
3F Error position arm up and down by
Trough to optos, up/ hand and make sure
Cuvette down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute
commands.
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 31 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Trough to sure that nothing is
Sample obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 3A6/3 !DILN Arm 1. Sample 1. Switch OFF the No
A7 Rotational position Opto analyzer; Rotate arm
Error - signal by hand and make
Trough to sure that nothing is
Dilution obstructing Arm

EM 200
Error Handling 8-17

Cuvette rotation

2. Interface 2. Then switch ON the


board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 32 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Sample to sure that nothing is
Cuvette obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 320/3 @S Arm 1. Sample 1. Switch OFF the Yes
21/32 Rotational position Opto analyzer; Rotate arm
2 Error - signal by hand and make
Sample to sure that nothing is
Cuvette obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call

EM 200
8-18 Error Handling

stepper motor Service Engineer


and its
connection
Arm 323/3 @S Arm 1. Sample 1. Switch OFF the Yes
24/32 Rotational position Opto analyzer; Rotate arm
5 Error - signal by hand and make
Sample to sure that nothing is
ISE obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 326 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
Error - signal by hand and make
Dilution sure that nothing is
Cuvette to obstructing Arm
Cuvette rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 327 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
Error - signal by hand and make
Dilution sure that nothing is
Cuvette to obstructing Arm
ISE rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough

EM 200
Error Handling 8-19

to reagent outer>
Execute commands

3. Up/Down 3. If the initialization or


and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 328 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Reagent 1 sure that nothing is
position to obstructing Arm
Cuvette rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 33 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - signal by hand and make
Cuvette to sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 330/3 @S Arm 1. Sample 1. Switch OFF the Yes
31/33 Rotational position Opto analyzer; Rotate arm
2 Error - or Home opto by hand and make

EM 200
8-20 Error Handling

Cuvette to signal sure that nothing is


Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 333/3 @S Arm 1. Sample 1. Switch OFF the Yes
34/33 Rotational position Opto analyzer; Rotate arm
5 Error - or Home opto by hand and make
ISE to signal sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 336 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
Error - or Home opto by hand and make
Cuvette to signal sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>

EM 200
Error Handling 8-21

and <Arm Up>


Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 337 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
Error - or Home opto by hand and make
ISE to signal sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 338 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm
error - or Home opto by hand and make
Cuvette to signal sure that nothing is
Trough obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to sample outer>
Execute <Sample
Outer to R1 Cuvette>
Execute <R1 Cuvette
to Trough> Execute
commands

EM 200
8-22 Error Handling

3. Up/Down 3. If the initialization or


and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 34 @S Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move arm up
Trough position and down by hand and
during optos, up/ make sure that nothing
sample down optos is obstructing Arm
operation and rotation movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute
<Arm Up> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 356/3 @S Arm Down 1. Sample 1. Switch OFF the No
57 Error - position Opto analyzer; Rotate arm
Dilution signal by hand and make
Cuvette sure that nothing is
obstructing Arm
rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to reagent outer>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call
stepper motor Service Engineer
and its
connection
Arm 35 @S Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON
Sample optos
position

EM 200
Error Handling 8-23

2. Interface Check the instrument.


card and its Check if the error
connector comes again
3. Probe goes 2. Remove the cover of
down but the sample arm and
doesn’t find check and clean
LLS signal obstacle opto
due to
problem in
LLS card or
its connector
4. Probe 3. Check the Arm
assembly assembly
4. Go to [Service
Check: Arm] menu;
Give <Initialize> and
<Arm Up> Execute
<Arm trough to
Sample outer>
Execute <Arm Down>
Execute commands
5. If still it is giving
error, call Service
Engineer
Arm 36 @S Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move SPT
Sample position arm up and down by
position optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to Sample outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections

EM 200
8-24 Error Handling

Arm 366/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No


67 Error - down opto, analyzer; Move SPT
Dilution ARM position arm up and down by
Cuvette opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 37 @S R1 down 1. Arm VOD 1. Switch OFF and Yes
error in opto & arm then switch ON the
cuvette optos instrument. Check if
the error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 370/3 @S Arm Down 1.ARM up/ 1. Switch OFF the No
71/37 Error - down opto, analyzer; Move SPT
2 Cuvette ARM position arm up and down by
opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement

EM 200
Error Handling 8-25

2. Arm 2. Then switch ON the


assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 373/3 @S Arm Down 1.ARM up/ 1. Switch OFF the No
74/37 Error - down opto, analyzer; Move SPT
5 ISE ARM position arm up and down by
opto, ARM hand and make sure
Home opto, that nothing is
ARM direction obstructing SPT
opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 376 @S Arm Down 1.ARM up/ 1. Switch OFF the No
Error - down opto, analyzer; Move SPT
Cuvette ARM position arm up and down by
opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement

EM 200
8-26 Error Handling

2. Arm 2. Then switch ON the


assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 377 @S Arm Down 1.ARM up/ 1. Switch OFF the No
Error - down opto, analyzer; Move SPT
ISE ARM position arm up and down by
opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 378 Arm Down 1.ARM up/ 1. Switch OFF the No
Error - down opto, analyzer; Move SPT
Cuvette ARM position arm up and down by
opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement

EM 200
Error Handling 8-27

2. Arm 2. Then switch ON the


assembly instrument; Go to
opto [Service Check: Arm]
connector menu; Give <Initialize>
(FRC) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 38 @S Arm Up 1. Arm VOD 1. Switch OFF the No
error - opto, arm analyzer; Move SPT
Sample position arm up and down by
Cuvette optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm trough
to Sample outer>
Execute <Sample
outer to R1 cuvette>
Execute <Arm Down in
R1 cuvette> Execute
<Arm Up> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 380/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No
81/38 Error - down opto, analyzer; Move SPT
2/ Cuvette ARM position arm up and down by
386/3 opto ,ARM hand and make sure
88 Home opto that nothing is

EM 200
8-28 Error Handling

,ARM obstructing SPT


direction opto movement

2. Arm 2. Then switch ON the


assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 383/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No
84/38 Error - down opto, analyzer; Move SPT
5 /387 ISE ARM position arm up and down by
opto ,ARM hand and make sure
Home opto that nothing is
,ARM obstructing SPT
direction opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 39 @S Arm Down 1. Arm VOD 1. Switch OFF and Yes
error - opto & arm then switch ON the
Trough optos instrument. Check if
during the error comes again
sample

EM 200
Error Handling 8-29

operation 2. Interface 2. Remove the cover of


card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving
assembly error, call Service
Engineer
Arm 398 Arm Down 1.ARM up/ 1. Switch OFF the No
error - down opto, analyzer; Move SPT
Trough ARM position arm up and down by
during opto ,ARM hand and make sure
Cuvette Home opto that nothing is
wash ,ARM obstructing SPT
direction opto movement
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up>
Execute <Arm trough
to Reagent outer>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 3A !S Arm VOD 1. VOD Opto 1. Check whether the When this
error - Sensor selected option is tube error
Sample and instead of tube a occurs,
Pos. cup is placed tests
associate
d with
that
sample
will move
to
pending
list. It can

EM 200
8-30 Error Handling

2. The 2. Check the Arm be


connectors alignment in [Service reschedul
Check]. If it is hitting at ed using
the edge, then align Work List
the probe using the button.
calibrate facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in Sample check and clean VOD
tray opto
4. Go to Service
Check: Arm Menu.
Click on <Initialize>
button. Push the Probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
5. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3A6/ !DILN Arm VOD 1. VOD Opto 1. Check the Arm No
3A7 error - Sensor alignment in [Service
Dilution Check]. If it is hitting at
Cuvette. the edge, then align
the probe using the
calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Dilution Click on <Initialize>
cuvette button. Push the probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B S! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
During Check]. If it is hitting at
Sample the edge, then align
dispense the probe using the
calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto

EM 200
Error Handling 8-31

3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Dispense Click on <Initialize>
cuvette button. Push the probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B DILN! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
During Check]. If it is hitting at
Diluted the edge , then align
Sample the probe using the
dispense calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Dispense Click on <Initialize>
cuvette during button. Push the probe
dilution gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B0/ !S Arm VOD 1. VOD Opto 1. Check whether the No
3B1/ Error - Sensor selected option is tube
3B2/ Cuvette and instead of tube a
cup is placed
2. The 2. Check the Arm
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align
the probe using the
calibrate facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in Sample check and clean VOD
tray opto
4. Go to Service
Check: Arm Menu.
Click on <Initialize>
button. Push the Probe
gently to cut the VOD

EM 200
8-32 Error Handling

opto so that VOD Error


will be generated and
Arm initializes.
5. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B3/ S! Arm VOD 1. VOD Opto 1. Check whether the No
3B4/ Error - Sensor selected option is tube
3B5/ ISE and instead of tube a
3B7 cup is placed
2. The 2. Check the Arm
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align
the probe using the
calibrate facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in Sample check and clean VOD
tray opto
4. Go to Service
Check: Arm Menu.
Click on <Initialize>
button. Push the Probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
5. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B6 !DILN Arm VOD 1. VOD Opto 1. Check whether the No
Error - Sensor selected option is tube
Cuvette and instead of tube a
cup is placed
2. The 2. Check the Arm
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align
the probe using the
calibrate facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in cuvette check and clean VOD
during opto
dilution
4. Go to Service
Check: Arm Menu.
Click on <Initialize>
button. Push the Probe

EM 200
Error Handling 8-33

gently to cut the VOD


opto so that VOD Error
will be generated and
Arm initializes.
5. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3B8 Arm VOD 1. VOD Opto 1. Check whether the No
Error - Sensor selected option is tube
Cuvette and instead of tube a
during cup is placed
Cuvette
2. The 2. Check the Arm
wash
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align
the probe using the
calibrate facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in cuvette check and clean VOD
during cuvette opto
wash
4. Go to Service
Check: Arm Menu.
Click on <Initialize>
button. Push the Probe
gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
5. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3C !S! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align
Sample the probe using the
operation calibrate facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during sample button. Push the probe
operation gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.

EM 200
8-34 Error Handling

4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3C !DILN! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align
Sample the probe using the
Dilution calibrate facility.
operation
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service
arm position Check: Arm Menu.
in Trough Click on <Initialize>
during sample button. Push the probe
operation gently to cut the VOD
opto so that VOD Error
will be generated and
Arm initializes.
4. If the initialization or
VOD generation fails,
call the Service
Engineer
Arm 3D S* Sample 1. Sample is 1. Place the sample at During
absent - not kept in the the required sample run, when
Pos. sample tube / position this error
cup at that occurs,
particular all tests
position associate
d with
2. Sample 2. Check the level of
that
tube / cup Sample and ensure
sample
absent at that that it is above the
moved to
particular Dead volume
pending
position
list. It can
3. LLS circuit 3. Call Service be
and its Engineer reschedul
connector ed using
problem Work List
button in
4. Sample is
Status
below the
Monitor
Dead volume
screen.
5. Arm
position in
sample tray
Arm 3E S** Sample 1. Liquid Level Call Service Engineer No
Liquid Detector The test of the Patient
Level Sample will be added
found to Pending list.
different at
Pos.

EM 200
Error Handling 8-35

Arm 3F @S Arm 1. Arm VOD 1. Switch OFF the No


Initialize opto, arm analyzer; Move SPT
Up/Down position arm up and down by
error optos, up/ hand and make sure
down optos that nothing is
and rotation obstructing SPT
optos movement
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up>
Execute <Arm Down in
Trough> Execute
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, call Service
Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Syringe 41 R1 1. Syringe 1. Switch OFF the No
Syringe position opto analyzer; Move the
Initialize Syringe up and down
error by hand and make
sure that nothing is
obstructing the
movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 42 @R1 R1 1. Syringe 1. Switch OFF the Yes
Syringe position opto analyzer; Move the
Up/Down Syringe up and down
error by hand and make
sure that nothing is
obstructing the
movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and

EM 200
8-36 Error Handling

<Aspirate/Dispense>
commands

3. Syringe up/ 3. If the initialization or


down motor aspirate/dispense
movement fails, call
Service Engineer
4A Reagent 1 1.Communica 1.Get PC checked by Yes
informatio tion data lost. IT-team, especially
n not 2.Test RAM, Hard-disk for
transmitte schedule data Bad sectors, 2.Anti-
d is not proper virus check, etc. are
e.g.R1 volume compliant to PC
has been specification.
sent/received 3.Re-load OS Image
without R1 on PC.
position. 4.Repeat the same run
and observe the
repeatability.
5.Share feedback
5A Reagent 2 1.Communica 1.Get PC checked by Yes
informatio tion data lost. IT-team, especially
n not 2.Test RAM, Hard-disk for
transmitte schedule data Bad sectors, 2.Anti-
d is not proper virus check, etc. are
e.g.R1 volume compliant to PC
has been specification.
sent/received 3.Re-load OS Image
without R1 on PC.
position. 4.Repeat the same run
and observe the
repeatability.
5.Share feedback
Arm 44 @R1 Up Opto 1. Up Optos Call Service Engineer No
failure 2. Optos
while connectors
Reagent 1
3. Opto
or sample
Supply
action

54 @R2 Up Opto 1. Up Optos Call Service Engineer No


failure 2. Optos
while connectors
Reagent 2
3. Opto
action
Supply
Stirrer B5 @STR1 Up Opto 1. Up Optos Call Service Engineer No
failure 2. Optos
while connectors
stirrer
3. Opto
action for
Supply
Reagent 1
C5 @STR2 Up Opto 1. Up Optos Call Service Engineer No
failure 2. Optos
while

EM 200
Error Handling 8-37

stirrer connectors
action for 3. Opto
Reagent 2 Supply

Syringe 52 @R2 R2 1. Syringe 1. Switch OFF the Yes


Syringe position opto analyzer; Move the
Up/Down Syringe up and down
error by hand and make
sure that nothing is
obstructing the
movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 61 @SY Syringe 1. Syringe 1. Switch OFF the No
R Initialize position opto analyzer; Move the
error Syringe up and down
by hand and make
sure that nothing is
obstructing the
movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 62 Sample 1. Syringe 1. Switch OFF the No
Syringe position opto analyzer; Move the
Up/Down Syringe up and down
error by hand and make
sure that nothing is
obstructing the
movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>

EM 200
8-38 Error Handling

commands

3. Syringe up/ 3. If the initialization or


down motor aspirate/dispense
movement fails, call
Service Engineer
Reagent 71 RGT1 Reagent 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate RGT
Initialize assembly of by hand and make
Rotational RGT tray sure that nothing is
error obstructing the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check:
Reagent Tray]; Give
<Initialize> command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Reagent 72 RGT1 Reagent 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate RGT
Rotational assembly of by hand and make
error RGT tray sure that nothing is
during run obstructing the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check:
Reagent Tray]; Give
<Initialize> command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Reagent 7F RGT3 RGT ARM 1. Make sure that arm No
Tray Interlock assembly UP assembly is not down
error opto & in RGT tray during
Direction service check for
opto. reagent i.e. service
command
1) RGT initialize 2)
RGT tray rotate to “X”
position. If arm
assembly is not down
then checkup opto &
direction opto signal.
2. Check opto
connectors are
connected properly or
not.

EM 200
Error Handling 8-39

Reagent V1 -- “Bottle 1. Scanned Decrease the Reagent No


Tray over-filled Reagent volume at the required
at Pos. volume is position
N“, where more than
N= 47ml for Large
Position bottle
No.
2. Scanned Decrease the Reagent
Reagent volume at the required
volume is position
more than 23
ml for Small
bottle
Sample 81 -- Sample 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate ASP
Initialize assembly of by hand and make
Rotational ASP sure that nothing is
error obstructing the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check:
Sample Tray]; Give
<Initialize> command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Sample 82 ASP2 Sample 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate ASP
Rotational assembly of by hand and make
error ASP sure that nothing is
during run obstructing the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check:
Sample Tray]; Give
<Initialize> command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Sample 8F ASP3 ASP ARM 1. Make sure that arm No
Tray Interlock assembly UP assembly is not down
Error opto & in ASP tray during
Direction service check for ASP
opto & ARM tray i.e. service
home opto command 1) ASP
initialize 2) ASP tray
rotate to “X” position

2. Check opto
connectors are
connected properly or
not.

EM 200
8-40 Error Handling

RCT Tray 91 RCT1 RCT tray 1. Position 1. Switch OFF the No


Initialize opto analyzer; Rotate RCT
Rotational assembly of by hand and make
error RCT tray sure that nothing is
obstructing the rotation
2. Stepper 2. Then switch ON the
motor and its instrument; Go to
connections [Service Check: RCT
Tray]; Give <Initialize>
command
3. Interface 3. If initialization fails,
card and its otherwise call Service
connector Engineer
4. Arms are
down in RCT

RCT Tray 92 RCT2 RCT tray 1. Position 1. Switch OFF the No


Rotational opto analyzer; Rotate RCT
error assembly of by hand and make
during run RCT tray sure that nothing is
obstructing the rotation
2. Stepper 2. Then switch ON the
motor and its instrument; Go to
connections [Service Check: RCT
Tray]; Give <Initialize>
command
3. Interface 3. If initialization fails,
card and its otherwise call Service
connector Engineer
4. Arms are
down in RCT

Dome 97 DA Dome Dome opened Close the dome No.


Level 2 abruptly above properly.
opened level 2
abruptly.
Schedule
d
skipped.
System 98 SYS! SYS error 1. Error in 1. Test will be added in No
Error communicatio pending list.
n between PC Reschedule the test
and Analyzer and perform.
during
schedule
transmission.
2. In case frequent
occurrence of error,
contact Service
Engineer.

EM 200
Error Handling 8-41

Hardware 99 HErr Hardware Check the Take the corrective No


Error Error assembly action for the error
which gave which occurred prior to
error prior to Hardware Error
Hardware
Error.
RCT Tray 9F RCT3 RCT ARM 1. Make sure that arm No
Interlock assembly UP assembly is not down
error opto & in RCT tray during
Direction service check for RCT
opto & ARM tray i.e. service
home opto command
1) RCT initialize
2) RCT tray rotate to
“X” position
2. Check opto
connectors are
connected properly or
not.
CRU A1 @CR CRU 1. CRU 1. Switch OFF the No
U Initializati Position opto analyzer; Move CRU
on error signal up and down by hand
and make sure that
nothing is obstructing
the CRU movement
2. RCT 2. Then switch ON the
Position opto instrument; Go to
signals [Service Check: CRU
Unit]; Give <Initialize>
and <Up/down>
commands
3. Interface 3. If the initialization or
card and its up/down movement
connector fails, otherwise call
Service Engineer
4. Stepper
motor and its
connections
5. RCT
alignment
CRU A2 @CR CRU Up/ 1. CRU 1. Switch OFF the No
U Down Position opto analyzer; Move CRU
error signal up and down by hand
and make sure that
nothing is obstructing
the CRU movement
2. RCT 2. Then switch ON the
Position opto instrument; Go to
signals [Service Check: CRU
Unit]; Give <Initialize>
and <Up/down>
commands

EM 200
8-42 Error Handling

3. Interface 3. If the initialization or


card and its up/down movement
connector fails, otherwise call
Service Engineer
4. Stepper
motor and its
connections
5. RCT
alignment
CRU A3 @CR CRU CRU down 1. Make sure the down No
U Down opto opto is working i.e.
Opto Fail CRU down opto LED
is ON when OPTO is
open and CRU down
opto LED is OFF
when CRU opto is cut
by interrupter. Also
ensure that the logic
low signal is reaching
to CPU board when
opto is open i.e. LED
is ON & logic high
(3.3v) signal reaches
the CPU board when
opto is cut i.e. LED is
OFF.
2. Check opto
connectors are
connected properly or
not.
CRU A4 @CR CRU Up CRU up opto 1. Make sure the up No
U Opto Fail opto is working i.e.
CRU up opto led is
ON when OPTO is
open and CRU up opto
led is OFF when CRU
opto is cut by
interrupter. Also
ensure that the logic
low signal is reaching
to CPU board when
opto is open i.e. LED
is ON & logic high
(3.3v) signal reaches
the CPU board when
opto is cut i.e. LED is
OFF.
2. Check opto
connectors are
connected properly or
not.

EM 200
Error Handling 8-43

CRU AF @CR CRU RCT_POSITIO 1. Make sure No


U Interlock N_OPTO and RCT_position opto is
Error CRU_UP_OP ON and
TO and CRU_UP_OPTO is
CRU_DOWN_ OFF and
OPTO CRU_DOWN_OPTO is
ON before CRU goes
down in RCT when
down command is
executed during
service check.
2) Ensure RCT position
opto is ON when cru
goes down in RCT
during run.
2. Check opto
connectors are
connected properly or
not.
Stirrer B1 @STR Stirrer Up/ 1. Position 1. Switch OFF the Yes
1 Down opto analyzer; Rotate stirrer
error for assembly of by hand and make
Reagent 1 stirrer sure that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to [Se
connector rvice Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<Down in Cuvette>
Execute <Stirrer Up>
Execute <R1 Cuvette
to Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
Stirrer B2 @STR Stirrer 1. Position 1. Switch OFF the Yes
1 Rotational opto analyzer; Rotate stirrer
error for assembly of by hand and make
Reagent 1 stirrer sure that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to
Trough> commands.

EM 200
8-44 Error Handling

3. Stepper 3. If the initialization or


motor rotation fails, call
Service Engineer
Stirrer B3 -- Stirrer Up/ 1. Position 1. Switch OFF the No
Down and opto analyzer; Rotate stirrer
rotation assembly of by hand and make
recovery stirrer sure that nothing is
fail for obstructing the rotation
Reagent 1
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to
Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
Stirrer B4 -- RCT 1. Position 1. Switch OFF the No
rotational opto analyzer; Rotate stirrer
error due assembly of by hand and make
to stirrer stirrer sure that nothing is
interlock obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to
Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
R1 Arm 64 -- Recoverin Due to -- Yes
g. R1 assembly
skipped error
and re-
scheduled
Stirrer BF @STR Stirrer RCT_POSITIO Make sure No
3 Interlock N_OPTO and RCT_POSITION_OPT
Error STR_HOME_ O is ON when stirrer
OPTO and down in cuvette
STR_DIRECTI command is executed
ON_OPTO' during service check
2. Check opto
connectors are
connected properly or

EM 200
Error Handling 8-45

not..

Stirrer C1 @STR Stirrer Up/ 1. Position 1. Switch OFF the Yes


2 Down opto analyzer; Rotate stirrer
error for assembly of by hand and make
Reagent 2 stirrer sure that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R2 Cuvette> Execute
<Down in Cuvette>
Execute <Stirrer Up>
Execute <R2 Cuvette
to Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
Stirrer C2 @STR Stirrer 1. Position 1. Switch OFF the Yes
2 Rotational opto analyzer; Rotate stirrer
error for assembly of by hand and make
Reagent 2 stirrer sure that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R2 Cuvette> Execute
<R2 Cuvette to
Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
Stirrer C3 -- R2 Stirrer 1. Position 1. Switch OFF the No
Rotational opto analyzer; Rotate stirrer
Error assembly of by hand and make
stirrer sure that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Stirrer]; Give
<Initialize> and

EM 200
8-46 Error Handling

<Stirrer Up> Execute


<Stirrer Arm Trough to
R2 Cuvette> Execute
<R2 Cuvette to
Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call
Service Engineer
Controller D1 SRAM 1. Interface 1. Switch OFF the No
Pressure Memory Board (CPU). Analyzer and Switch it
Error on after few minutes.
G1 Low 1. 2. Check the pressure
Pressure Malfunctioning unit for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
Pressure G2 High 1. Check the pressure No
Pressure Malfunctioning unit for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
Reagent H1 RGT! RGT 1. Reagent 1. Check the No
Tray Cover tray cover placement of Reagent
Open placement Cover
2. The logic 2. Check the logic
levels at the levels at the baseboard
baseboard connectors/connector
connectors connections and verify
for proper functionality.

3. Connector
connections

Dome H2 Dome Dome is open Close the dome No


open Level 1 properly
Level 1
Dome H3 Dome Dome is open Close the dome and No
and RGT open Level 1 RGT cover properly
cover Level 1 and RGT
and RGT cover is open
cover
open.
Dome H4 Dome Dome is open Close the dome No
open Level 2 properly.
Level 2
Check the opto

EM 200
Error Handling 8-47

Dome H5 Dome Dome is open Close the dome and No


and RGT open Level 2 RGT cover properly.
cover Level 2 and RGT
and RGT cover is open Check the opto.
cover
open.
Dome H6 Dome Dome cover is Close the dome cover No
open open open Level 2 properly
Level 1
and Level
2
Dome H7 Dome Dome cover is Close the dome cover No
and RGT open open Level 1 and RGT cover
cover Level 2 and Level 2 properly
and Dome and RGT
open cover is open
Level 1
and RGT
cover
open
Cleaning I1 -- Low 1. Cleaning 1. Check the Cleaning No
Can Cleaning solution Level solution Level
Solution
Level 2. Sensor 2. Check the Sensor
output of Level Output of Level Sensor
Sensors
Waste J1 -- Empty 1. Waste 1. Check the Waste No
Can Waste Level Level
Reservoir/
2. Sensor 2. Check the Sensor
Waste
output of Level Output of Level Sensor
Tank full
Sensors
to
Capacity
Bio- K1 -- Bio- 1. Bio-Waste 1. Check the Bio- No
Waste Waste Level Waste Level
Can Tank Full
to 2. Sensor 2. Check the Sensor
Capacity output of Level Output of Level Sensor
Sensors
Pressure L1 -- Low DI 1. Check the pressure No
Water Malfunctioning unit for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
DI Water M1 -- DI Water 1. DI Water 1. Check the DI Water No
Can Tank Level Level
Level less
2. Sensor 2. Check the Sensor No
than or
output of Level Output of Level Sensor
equal to
Sensors
50%

EM 200
8-48 Error Handling

Photome N1 -- PDC 1. PDC Card. 1. Goto Service Check No


ter Operation and give Emergency
al ERROR Stop Command.
2. Interface 2. Switch OFF the
Board and its Analyzer and Switch it
connector. on after few minutes.
Photome N2 -- PDC 1. PDC Card. 1. Goto Service Check No
ter Communi and give Emergency
cation Stop Command.
ERROR
2. Interface 2. Switch OFF the
Board and its Analyzer and Switch it
connector. on after few minutes.
Barcode P1 -- Reagent 1. Reagent 1. Check the Reagent No
Scanner Barcode Barcode barcode scanner
Scanner Scanner
Failure
2. Reagent 2. Check the Reagent
barcode barcode scanner
scanner connections
connections
3. Interface
board and its
connections
Barcode Q1 -- Sample 1. Sample 1. Check the Sample No
Scanner Barcode Barcode barcode scanner
Scanner Scanner
Failure
2. Sample 2. Check the Sample
barcode barcode scanner
scanner connections
connections
3. Interface
board and its
connections
Reagent R1 RGT!! RGT 1. Reagent 1. Check the No
Tray Cover tray cover placement of Reagent
open for 5 placement Cover
minutes
2. The logic 2. Check the logic
under
levels at the levels at the baseboard
standby
baseboard connectors/connector
connectors connections and verify
for proper functionality.

3. Connector
connections

Reaction T9 @TM RCT 1. RCT heater 1. Go to [Service No


Tray P Temperat and its Check: RCT Temp];
ure out of connections Give <Read>
range command. RCT
temperature should be
displayed along with
the RCT sensor status

EM 200
Error Handling 8-49

2. Interface 2. If the temperature is


board and its not coming within
connections range, call Service
Engineer

3. RCT
sensors and
its
connections
Reaction DC DC* Reaction 1. Cuvettes Retest the result. No
Tray of an on- dirty
board
diluted
sample is
performed
in Dirty
Cuvette
Dome DM Close Dome is open Close the dome No
Dome to properly.
Proceed

EM 200
Part

IX
Configuration 9-2

9 Configuration
This section describes step-by-step procedures for some common configuration tasks. You must
have the required user access level to perform these tasks.

See the following section for more details:

Login and password recovery

Setting UI language

Setting test sequence

Access control

Setting connection with host computer

Entering the master details

Create profile

9.1 Login and password recovery


This section describes the procedure to recover the password for the user login Guest, in case you
lose or forget the password. However, the password for other user logins can be reset by the
administrator for their login from the Settings > User Rights screen.

For more information on setting the user access see section User Rights.

Follow this procedure for recovering login password:

1. In the login screen, enter Guest in the Login ID textbox and click on the link “Click Here” as
shown in figure below.

On clicking, a text file is created which contains password details of the user and sends to
the location C:\MultiXLLOG. The following screen will be displayed.

2. Go to folder C:\MultiXLLOG, and send the generated text file, for example
‘ForgotPWD20110305.Txt’ to the service engineer.

EM 200
9-3 Configuration

3. Click OK to close.

9.2 Setting UI language


The user interface language can be changed according to your choice from the available list of
languages. MultiXL application uses this language in dialog boxes, menus, captions, header in the
screen, and other items in the user interface.

List of Languages supported: English, Chinese, Italian, Spanish, Portuguese, Russian, French,
German, Polish and Czech.

To change the language, do the following:

1. Click on the Settings from the main menu.

2. Go to System Parameters screen, and click on the three dotted button available on the
Default Language parameter.

4. Select the desired language from the Set Language drop down list.

5. Click OK. The captions on the screen will appear in the selected language. Alternatively,
language can also be changed using F10 key from the keyboard.

6. Click on Save to save the settings.

9.3 Setting test sequence


See the following procedure to set the display sequence:

1. Go to Settings in the main menu.

EM 200
Configuration 9-4

2. Select Test Sequence screen.

3. Select the appropriate tests sequence option.

4. Rearrange the tests as required using the buttons provided for sorting.

5. After making changes, click on Save.

Once the test display sequence is set, the tests will appear in the specified sequence.

The display sequence of tests will be changed and displayed in the following screen.

Patient Entry

Reports

Search

Test Parameter > Test Details

Test Parameter > Test Volumes

Test Parameter > Reference Ranges

Profiles/Calc > Profiles

QC Calibration > Calibration

9.4 Access control


Administrator of the system can create new user and provide access control through the User Right
screen.

Refer section User Right for more details.

See the following sections in more details:

To create new user login

To provide access rights to existing user

To change the user ID password

9.4.1 To create new user login


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the CLEAR button, and then enter the user name in the User Name field.

4. Now enter the type of user using User Type drop down list. Four options are available:

Super-User
User
Analyst
Doctor

EM 200
9-5 Configuration

A user defined with User Type as Analyst or Doctor will also appear in the list of
Analyst and Doctor respectively from Patient Entry screen.

5. Enter the following fields:

On Panel
Address
City
State
Country
Zip Code
Telephone
Email ID
Login ID
New Password
Confirm Password

User must enter the details for the parameters that are marked with red asterisk.

6. Once all the data are entered, click on the SAVE button. This will create the user ID.

7. User can use this user ID for system login.

9.4.2 To provide access rights to existing user


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the search button. On clicking, the HELP window will be displayed containing
the list of existing user IDs.

4. Now, select the required user name by double click and click EDIT button.

EM 200
Configuration 9-6

5. Check or uncheck the check boxes under column Full Access as per requirement, and click
SAVE to confirm. The settings will be saved for that user id.

User must replace the old password with the new password before saving the
settings.

9.4.3 To change the user ID password


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the search button. On clicking, the HELP window will be displayed containing
the list of existing user IDs.

4. Now, select the name of the user by double click and click EDIT button.

EM 200
9-7 Configuration

5. Now enter the old password, new password, and confirm password and then click SAVE to
confirm the settings.

6. If the user has forgotten the password, click on EDIT, select the FORGOT PASSWORD
check box and then enter the New Password and Confirm Password.

9.5 Connection to Host PC


This section explain you how to establish a connection between analyzer's Data Station and Host
PC in LAN (Local Area Network) and Peer-to-peer network.

Refer section Host Settings for more details.

See the following sections in more details:

In peer to peer network (using serial port)

In LAN (Local Area Network)

EM 200
Configuration 9-8

9.5.1 In peer to peer network

Follow the procedure to connect with host:

1. Click on Settings from the main menu.

2. Select Host Settings screen.

3. Click EDIT.

4. Select option RS 232C, and enter the following parameters.

Port No.

Baud Rate

Parity

Data Length

Stop Bits

Make sure that baud rate, parity, data length and start bit settings entered in the
host computer should match with analyzer's PC.

5. After entering the details, click CONNECT AND SAVE.

On successful connection, connection between the LIS and host will be established, and
data will be saved.

Use CHECK CONNECTION to check the communication.

EM 200
9-9 Configuration

9.5.2 In LAN (Local Area Network)

Follow the procedure to connect with host:

1. Click on Settings from the main menu.

2. Select Host Settings screen.

3. Select option TCP/IP, and enter the following parameters.

IP Address

Port No.

Make sure that the port number entered in the host computer should match with
analyzer's PC.

4. After entering the details, click CONNECT AND SAVE.

On successful connection, connection between the LIS and host will be established, and
data will be saved.

Use CHECK CONNECTION to check the communication.

EM 200
Configuration 9-10

9.6 Entering the master details


This section explains you how to enter master details through Master screen. Details entered here
will be displayed on the various screen.

The master patient database stores information like:

Area from which the samples are collected

Name of referring doctor

Name of analyst

Name of laboratory

Name of manufacturer

Minimum and maximum reference range

Types of unit

Calculation formula

Instrument

See section Master for more details.

9.6.1 Add area


To add area name

1. Click Master from main menu.

2. Select Area screen.

3. Enter the area name.

4. Click on SAVE.

5. This will add the area name and displayed in the grid.

To edit area name

1. Click Master from main menu.

2. Select Area screen.

3. Select the area name to be updated.

4. Click on EDIT.

5. Change the area name.

6. Click on SAVE.

To delete area name

EM 200
9-11 Configuration

1. Click Master from main menu.

2. Select Area screen.

3. Select the area name to be updated.

4. Click on DELETE.

5. Change the area name.

6. Click on SAVE.

9.6.2 Add doctor


To add doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Enter the name of doctor and its demographics.

4. Click on SAVE.

5. This will add the doctor name and displayed in the grid.

To edit doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Select the name of doctor to be updated.

4. Click on EDIT.

5. Edit the name or other details.

6. Click SAVE .

7. This will update the doctor's name and displayed in the grid.

To delete doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Select the name of the doctor to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

EM 200
Configuration 9-12

9.6.3 Add analyst


To add analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Enter the name of analyst and its demographics.

4. Click SAVE.

5. This will add the analyst name and displayed in the grid.

To edit analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Select the name of analyst to be updated.

4. Click EDIT.

5. Edit the name or other details.

6. Click SAVE .

7. This will update the analyst's name and displayed in the grid.

To delete analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Select the name of the analyst to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.4 Add laboratory


To add laboratory name

1. Click Master from main menu.

2. Select Laboratory screen.

3. Enter the name of laboratory and its demographics.

4. Click SAVE.

5. This will add the laboratory name and displayed in the grid.

To edit laboratory name

EM 200
9-13 Configuration

1. Click Master from main menu.

2. Select Laboratory screen.

3. Select the name of laboratory to be updated.

4. Click EDIT.

5. Edit the name or other details.

6. Click SAVE .

To delete laboratory name

1. Click Master from main menu.

2. Select Laboratory screen.

3. Select the name of the laboratory to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.5 Add manufacturer


To add manufacturer name

1. Click Master from main menu.

2. Select Mfg screen.

3. Enter the name of manufacturer.

4. Click SAVE.

5. This will add the name and displayed in the grid.

To edit manufacturer name

1. Click Master from main menu.

2. Select Mfg screen.

3. Select the name of manufacturer to be updated.

4. Click EDIT.

5. Edit the name.

6. Click SAVE .

7. This will update the manufacturer's name and displayed in the grid.

To delete manufacturer name

1. Click Master from main menu.

EM 200
Configuration 9-14

2. Select Mfg screen.

3. Select the name of the manufacturer to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.6 Add reference range


To add reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Enter the min and max reference range.

4. Click SAVE.

5. This will add the name and displayed in the grid.

To edit reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Select the reference range to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the reference range and displayed in the grid.

To delete reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Select the name of the reference range to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.7 Add unit


To add a unit

1. Click Master from main menu.

2. Select Unit screen.

3. Enter the unit.

EM 200
9-15 Configuration

4. Click SAVE.

5. This will add the unit and displayed in the grid.

To edit a unit

1. Click Master from main menu.

2. Select Unit screen.

3. Select the unit to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the unit and displayed in the grid.

To delete a unit

1. Click Master from main menu.

2. Select Unit screen.

3. Select the unit to be deleted.

4. Click DELETE.

5. This will delete the unit from the grid.

9.6.8 Add calculation formula


To add a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Enter the calculation formula.

4. Click SAVE.

5. This will add the calculation formula and displayed in the grid.

To edit a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Select the calculation formula to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the calculation formula and displayed in the grid.

EM 200
Configuration 9-16

To delete a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Select the calculation formula to be deleted.

4. Click DELETE.

5. This will delete the calculation formula from the grid.

9.6.9 Add instrument


To add instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Enter the name of instrument.

4. Click SAVE.

5. This will add the instrument name and displayed in the grid.

To edit instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Select the name of instrument to be updated.

4. Click EDIT.

5. Edit the name.

6. Click SAVE .

7. This will update the instrument's name and displayed in the grid.

To delete instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Select the name of the instrument to be deleted.

4. Click DELETE.

5. This will delete the instrument's name from the grid.

EM 200
9-17 Configuration

9.7 Archive Data


The archive data is the process of moving patient results to separate data storage for long-term use
Data archives consist of older patient data which can be used for future reference, if required.

Data archiving improves the performance of (Live) database with the following key benefits.

Faster search of patient results

Quick accessibility of patient results

Reduces the amount of storage required for patient results.

For archiving and restoring patient data, the Archive option will appear on the main menu as shown in
the following figure.

Archive option on the main menu screen

Initially, when the software is installed, this option is not visible. It appears only when the patient
results reaches to a specific limit. In this case, at specific time interval, software automatically
prompts the user to archive the data when it is necessary. Thereafter, this option will be always
visible.
It is advisable to archive the older patient results to separate data storage.

It is mandatory to archive the data before starting the batch run when the patient
result reaches a specific limit (software shows alert message, as required).

Only Patient results will be archived. The Calibration, Control and Consumables
data will always remain in the (Live) Database. While archiving the patient
results, the required additional information such as Area, Location, Doctor,
Reference Range etc are copied to the separate data storage (Archive Database)
and available while reviewing archived results.

This section includes:

Archiving Data.

EM 200
Configuration 9-18

Viewing Archived Data

Observations

9.7.1 Archiving Data


Steps to follow the procedure for archive data:

1. Click on the Archive option from the main menu. following screen will be displayed

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archive Patient Data option, and click OK,the archive process will start and the
status will be displayed as shown below

EM 200
9-19 Configuration

During the archive process, all other menus will be disabled.

4. After completing the archive process, a message “Archived data successfully” will be
displayed on the screen.

9.7.2 Viewing Archived Data


Steps to follow the procedure for Viewing Archive Data:

1. Click on the Archive option from the main menu. Following screen will be displayed.

EM 200
Configuration 9-20

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archived List to View Reports option then select the desired archive to connect
to archive database to view the reports.

4. On clicking OK a message will be displayed “Connection successful. You may view the
Patient Reports”.

EM 200
9-21 Configuration

During this time, only Reports, Search and Shut down menus are available. Rest
of the menus will not be accessible.

5. After connecting to achieve database, user will able to connect to Live database again by
selecting Live record from the list.

9.7.3 Observations
When the archive database is connected, the patient data can be viewed only in the following screen:

Reports > Patient Report

Reports > Result Reprint

Reports > Test Statistics

Reports > Error Log

Reports > Reaction Curve

Reports > Other > Reagent Consumption

Search > Patient Results

Other main menu screens are not accessible for the user except the following screens:

EM 200
Configuration 9-22

Search

Reports

Archive

Shutdown

During batch run, the Archive screen will not be accessible.

9.8 Create profile


This section explain you how to create and delete the profile.

See the following section in more details:

Add profile

Delete profile

9.8.1 Add profile


The profile can be created from the Profiles screen.

The procedure is given below:

1. Open Profiles/Calc screen.

2. Enter the profile name and profile report name in the respective text box.

3. Add the required tests by clicking on the test name from the Tests grid.

4. Click on SAVE to save the profile.

5. Once the profile is saved, the name appears in the Profiles grid.

9.8.2 Delete profile


Use the following instructions to delete the profile:

1. Open Profiles/Calc screen.

2. Select the profile name from the Profile grid.

3. Click Delete.

4. Click Yes.

EM 200
Part

X
Result Flags 10-2

10 Result Flags
Measurement result flags are printed out together with the measurement result. See the section Flag
List in more details.

10.1 Flag List


Seri Flags Cause
al
No.
1 # This flag is issued to indicate that the result is obtained from an auto-rerun.
This flag is issued for all rerun results.
2 F This flag is used to indicate that correlation correction has been used to
calculate and declare the final result. That is, this flag is issued when in the
equation Y = aX + b, a is not 1 and/or b is not zero.
3 -1SD This flag is issued with control results when the result is below 1SD limit.
4 +1SD This flag is issued with control results when the result is above 1SD limit.
5 -2SD This flag is issued with control results when the result is below 2SD limit.
6 +2SD This flag is issued with control results when the result is above 2SD limit.
7 -3SD This flag is issued with control results when the result is below 3SD limit.
8 +3SD This flag is issued with control results when the result is above 3SD limit.
9 ?SD This flag is issued with control results when the target Mean and SD values
have not been defined for the control in Consumables screen. Therefore, flags
such as “±1SD”, “±2SD”, “±3SD” cannot be given.
10 CALC! Calculated Item is not calculated for any of the following reasons.
1. Denominator is 0 (zero) in the process of calculation for compensation.
2. Test result to be used for Calculated Item has not been measured yet.
3. Any test to be used for Calculated Item has data/calibration alarms, such
as NOCAL.
4. Any test to be used for Calculated Item errors (S*, R1* etc.)
11 NOCAL This flag is issued with patient or control result and indicates that the
calibration table is not available for result calculation. The calibration table
needs to be checked and corrected to calculate a result (e.g. calibration is
not present or number of standards provided for calibration is less than
required.
12 MONO This flag is issued with patient and control results when, for the concerned
test, the absorbance’s of the calibrators are not changing monotonically with
their respective concentration in the calibration table.
13 V-D This flag is issued with patient results and indicates a Decreased volume run.
14 V-I This flag is issued with patient results and indicates Increased volume run.
15 PD This flag is issued with patient and control results to indicate that the sample
was pre-diluted.
16 P* This flag is issued with patient and control serum results to indicate that
prozone (antigen excess) has occurred.
17 TEC-H Upper technical limit violated. Measured value or absorbance slope is higher
than the set maximum technical limit. (Set Maximum limit to zero to cancel
the check for TEC-H flag.)

EM 200
10-3 Result Flags

18 TEC-L Lower technical limit violated. Measured value or absorbance slope is lower
than the set minimum technical limit. (Set Minimum limit to zero to cancel
the check for TEC-L flag.)
19 RANGH 1. This flag is issued with patient and control results to indicate that the
absorbance of the sample is higher than the absorbance of the highest
concentration calibrator in the calibration table for an increasing reaction
direction test.
2. This flag is also issued with patient and control results if the absorbance of
the sample is lower than the absorbance of the highest concentration
calibrator in the calibration table for a decreasing reaction direction test.
20 RANGL 1. This flag is issued with patient and control results to indicate that the
absorbance of the sample is lower than the absorbance of the blank (or
lowest concentration calibrator) in the calibration table for an increasing
reaction direction test.
2. This flag is also issued with patient and control results if the absorbance of
the sample is higher than the absorbance of the blank (or lowest
concentration calibrator) in the calibration table for a decreasing reaction
direction test.
21 EVH This flag is issued with the patient result when the result is higher than the
concentration of the highest calibrator and is calculated by extra-polating the
calibration curve on higher side.
Extrapolation % (maximum 20%) is set in system parameters.
22 EVL This flag is issued with the patient result when the result is lower than the
concentration of the lowest calibrator and is calculated by extra-polating the
calibration curve, upto zero.
Extrapolation % (maximum 20%) is set in system parameters.
23 H Measured value is larger than upper limit set for normal value range for the
corresponding age, sample type and category.
24 L Measured value is smaller than lower limit set for normal value range for the
corresponding age, sample type and category.
25 PANH High Panic value alarm. This flag is issued with a sample result to indicate
that the patient result is higher than the Upper Panic Limit programmed in
Test Parameter for the corresponding age, sample type and category.
26 PANL Low Panic value alarm. This flag is issued with a sample result to indicate
that the patient result is lower than the Lower Panic Limit programmed in
Test Parameter for the corresponding age, sample type and category.
27 LINxx Linearity abnormal (checked only for Rate A and Rate B assays). When the
reaction during measurement points M2S and M2E is non-linear beyond the
set limit for linearity of reaction, this flag is given. The percent linearity of
reaction is indicated by a two digit number xx after “LIN”.
28 Lim0 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there is no measurement point available for result calculation,
then this flag is issued and result will be “NA”.
29 Lim1 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there is only one measurement point available for result
calculation, then this flag is issued and result will be “NA”.
30 Lim2 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there are only 2 measurement points available for result

EM 200
Result Flags 10-4

calculation, then this flag is issued.


31 ~ When Linearity Extension Logic method is used to reduce the measurement
range to match absorbance range setting, this flag should be given.
(Technical Limit is zero, Reaction Absorbance Limit is non-zero. More than 2
measurement points are available for result calculation)
32 AbsLim This flag is issued for End-Point chemistries and Rate chemistries when the
absorbance is beyond the Reaction Absorbance Limit set in Test Parameter.
For Rate-chemistries, this flag will be issued when Technical limit is set. In
this case, Extension Logic will not be applied.
33 RgtAbsMin This flag indicates that the reagent 1 absorbance is lower than the
programmed Reagent Absorbance Minimum.
If at least 1 Blank Replicate is available without RgtAbsMin and/or
instrument-related Flag then calibration table will get updated.
34 RgtAbsMax This flag indicates that the reagent 1 absorbance is greater than the
programmed Reagent Absorbance Maximum.
If at least 1 Blank Replicate is available without RgtAbsMax and/or
instrument-related Flag then calibration table will get updated
35 ??? This flag is issued when the denominator becomes zero during calculation or
an overflow error occurs in logarithmic or exponential calculation.
36 @TMP This flag is issued to photometric results when the RCT temperature was out
of range while the measurement was in process. Flag is not applicable to ISE
results.
37 TO This flag indicates Time Out received from the analyzer, instead of the result.
38 Cal* This flag is issued with patient and control results to indicate that the results
are being calibrated with previous calibration data.
39 CAL** This flag is issued with patient and control results to indicate that the test is
performed with Un-Calibrated Reagent. This flag is issued only when Online
Calibration option (to trace Reagent Bottle change-over) is selected for a test
from Test Parameter.
40 R1? /R2? This flag is issued with the results when test is performed with the over-filled
reagent volume during run. In this condition, the result will be declared with
NA.
41 D? This flag is issued with the result when the test is performed with overfilled
Diluent or Urine ISE Diluent volume during run. In this condition, the result will
be declared with NA.
42 COMM* This flag is issued with the results in the following cases:
Absorbance of Reading Area (M1S-M1E, M2S-M2E) is lost
Absorbance after Reagent 1 addition is lost
Absorbance after Reagent 2 addition is lost for 2-Reagent chemistry.
In this condition, the results will be declared with NA.
43 W* During carry over pair process, if the Detergent Wash/Reagent Wash solution
is not found on Reagent Tray, VOD error or any other error is occurred (during
wash operation), then this flag is issued with the result.
44 RD This flag is issued with the results when test is performed from discarded
reagent bottles, during run. In this condition, the result will be declared with
NA
45 N! This flag is issued to patient results having a negative value. Negative results
can be sent to host and also for a re-run based on user selection. If "Print
Negative Result" check-box is unchecked in System Parameters, then in this

EM 200
10-5 Result Flags

condition, negative test result will be printed as zero in Patient Report and N!
Flag will be printed only if “Hide Flags” option is not selected during printing.
46 HV! This flag is issued when, during RUN the measured volume in the reagent
bottle is more than the specific capacity of that particular bottle type (small/
large).

NOTE: This flag is issued only for fresh/new reagent bottles.

47 LV! This flag is issued when, during RUN the measured volume in the fresh or
used reagent bottle is below the tolerance of last known level.

48 DA This flag is issued when, test affected due to dome opened abruptly (level 2)
and ARM movement is stopped.

49 ABS! This flag is issued when an Absorbance in a Reaction curve is above 3.0,

In entire reaction curve, this flag is issued in following condition:

o Primary ABS > 3.0 or

o Secondary ABS > 3.0 or

o For a chemistry with dual-wavelength, (Primary ABS – Secondary ABS) >


3.0

In this condition result will be declared with NA.

EM 200
Part

XI
11-2 Maintenance

11 Maintenance
This section provides the necessary and minimal maintenance procedures in order to ensure that the
analyzer operates correctly and provides the accurate measurement results.

The analyzer has been designed to require very little user maintenance compared to the other
analyzers of the same class. Regular cleaning and periodic maintenance as per the schedule keeps
the analyzer in good working condition without any trouble.

Change the reagent bottles from time to time before adding the fresh reagent. It
is recommended to check and maintain a stock of spares and consumables.

To do this, see the following maintenance procedure:

Daily Maintenance

Weekly Maintenance

Quarterly Maintenance

Annual Maintenance

Preventative Maintenance

11.1 Daily Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

The inside of the Sample Tray and Reagent Tray are exposed to splashes of
samples / reagents, contact with ambient room air and condensation on the
walls. This gives rise to bacterial and fungal growth in these parts of the
analyzer. To avoid such conditions, clean the inside of the trays thoroughly on
a regular basis or when a spill occurs.

Start of the day procedure


Serial Number Description
1 Fill the DI water can.
2 Fill the cleaning solution can.
3 Clean the probes tips and stirrer paddle with tissue paper soaked in alcohol.
4 Perform the sample and reagent probe wash.
5 Replace the printer paper if necessary.

EM 200
Maintenance 11-3

6 Perform Prime, Cuvette Wash and Probe Wash operations & Check Cell
Blanks.
7 Perform the photometer check and verify that the auto span check has passed
successfully. (Observe after 30 minutes warm-up).
8 Verify the reagent tray and reaction tray temperature.
9 Remove any condensation present on the walls of the reagent tray, near the
reagent bottle necks or on the barcode label using a dry tissue.
10 In case of ISE unit, ensure that there is enough CAL A and CAL B solution.
11 Replenish or replace the reagents if necessary.
End of the day Procedure
Serial Number Description
1 Remove and discard all sample / standard and controls cups or tubes from the
sample tray.
2 Carry out Acid and Alkali Wash (Auto Wash) if Latex based chemistries are
used during the day.
3 Perform Water save.
4 Take a backup of all patient reports.
5 Turn off the main switch located on the left side of the analyzer (in case ISE
and if reagent cooling required, leave switch on).
6 Remove any condensation present on the walls of the reagent tray or near the
reagent bottle necks using a dry tissue.
7 Empty the Waste and Bio-hazardous waste cans.
8 Clean analyzer external surface to remove residues of serum, reagents etc.

11.2 Weekly Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Serial Number Description


1 Clean and fill the DI water can.
2 Clean the Cleaning solution can.
3 In case of ISE unit, ensure that there is enough CAL A and CAL B
solution.
4 Clean the stirrer paddles and laundry probes with alcohol.
5 Check the syringe assembly and surrounding tubes.

EM 200
11-4 Maintenance

6 Clean the computer, trolley, monitor, keyboard and printer external


surface.
7 Clean the area around the analyzer, and discard any unwanted item.
(Maintain proper room cleanliness).
8 Clean the sample or reagent probe.
9 Clean the Sample tray.
10 Clean the Reagent tray
11 Perform an auto span check and note down the gain values for all the
wavelengths.
12 Perform a cuvette rinse and check cuvette blanks
13 Perform a precision check and note down the %CV for an end point and
kinetic test.
14 Clean the barcode reader window in the piece of RGT base unit

11.3 Quarterly Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols.

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Serial Number Description


1 Clean and fill the DI water can.
2 Clean the Cleaning solution can.
3 In case of ISE unit, ensure that there is enough CAL A and CAL B solution.
4 Clean the stirrer paddles and laundry probes with alcohol.
5 Check the syringe assembly and surrounding tubes.
6 Clean the computer, trolley, monitor, keyboard and printer external surface.
7 Clean the area around the analyzer, and discard any unwanted item.
(Maintain proper room cleanliness).
8 Clean the Waste hub.
9 Clean the sample or reagent probe.
10 Clean the Sample tray.
11 Clean the Reagent tray
12 Perform an auto span check and note down the gain values for all the
wavelengths.
13 Perform a cuvette rinse and check cuvette blanks
14 Perform a precision check and note down the %CV for an end point and
kinetic test.

EM 200
Maintenance 11-5

15 Clean the barcode reader window in the piece of RGT base unit

11.4 Annual Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols.

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Average life of the Lamp is 1000 hours. Replacement of Lamp depends on its
usage and ON Time.

Serial Number Description


1 Clean the Waste can.
2 Clean the Bio hazardous waste can.
3 Clean and fill the DI water can.
4 Clean the cleaning solution can.
5 In case of ISE unit, ensure that there is enough CAL A and CAL B solution
6 Replace External Tubing to the Waste, Bio Hazardous Waste, Cleaning
Solution And DI Water Cans.
7 Clean the Analyzer External Surface.
8 Clean the computer, monitor, keyboard and printer external surface.
9 Clean the area around the analyzer, and discard any unwanted item
(maintain proper room cleanliness).
10 Check and replace the sample probe if necessary.
11 Check and replace the stirrer paddle.
12 Replace the laundry probes.
13 Clean the Sample tray.
14 Clean the Reagent tray.
15 Check and replace the syringe dilutor assembly.
16 Clean the fans.
17 Clean the bar code readers.
18 Perform the auto span check and note down the gain values for all the
wavelengths.

EM 200
11-6 Maintenance

19 Perform a cuvette rinse.


20 Perform a precision check and note down the %CV for an end point and
kinetic test.
21 Replace the lamp.
22 Clean the internal surface free of dust.
23 Perform an auto span check and note down the gain values for all the
wavelengths.
24 Carry out site verification for temperature, line voltage, electrical ground,
ventilation, external interferences, room lighting, and laboratory cleanliness
practice. Refer section 3.4 Site Requirement for more details.
25 Make a detailed entry in the error log book, of the maintenance carried out
and site verifications.

Average life of water filter is 3 months. Replacement of water filter depends on quality of DI water
used.

DI water pump has average life of around 4000 hrs. Depending on the use of the analyzer, DI water
pump may need periodic replacement.

11.5 Replacement Schedule for Spares and Consumable

Spares/
Serial Number 3 Months 6 Months 9 Months 12 Months
Consumables

1 SAMPLE PROBE

2 STIRRER PADDLE

3 CUVETTE DRYER
BLOCK (TEFLON)

4 LAUNDRY
DISPENSE TUBING

5 LAUNDRY
ASPIRATION
TUBING

6 LAUNDRY PROBE
ASSY

7 PHOTOMETER
LAMP ASSY

11.6 Preventative Maintenance


This section tell you the necessary preventive maintenance for the analyzer.

When any abnormal conditions are found in the analyzer, the operator is requested to check the
following items:

1. Preparation and preservation methods of reagents.

2. Preparation and preservation methods of sample.

EM 200
Maintenance 11-7

3. Operational procedures of the analyzer and maintenance work.

When such an abnormal condition is considered to be caused by an electrical or


mechanical failure, do not try to carry out the inspection of the analyzer by your
own and call for service at our customer service department.

Malfunction at the Time of Operation

Anomalous Measurement Results

High Resultant Values from a Specific Method for all Samples

Low Resultant Values from a Specific Method for all Samples

Randomly Derived Erroneous Measurement Results

Anomalous Resultant Values from all Methods for a Sample

Check for Preparation of Reagent, Calibrator or QC Sample

11.6.1 Information Requested by Our Customer Service Department


When any technical service will be called for at our customer service department, the following
information is requested to be prepared.

Trouble in assay.

Serial number of analyzer in use.

Method code in question.

Explanation of encountered trouble.

Serial number and lot number of reagent, calibrator and QC sample in use.

A few calibration results that were carried out recently.

A few measurement results of QC sample, that were carried out recently.

Measurement results.

Trouble in analyzer.

Serial number of analyzer in use.

Software version numbers in use (PC, Operating System, Sub-CPU).

Explanation of the relevant alarm and problem

Other information about the analyzer in use and maintenance.

11.6.2 Malfunction at the Time of Operation


While functioning of the analyzer when it is suddenly deactivated check the following possibilities:

1. Check that the main switch located on the left hand side of the analyzer is at "ON" position.

EM 200
11-8 Maintenance

2. Check that the main fuses are not burnt. When the main fuses are checked, turn the main
switch off without fail and then pull out the plug of power supply cable from its receptacle on
the analyzer. Open up the fuse cover and pull the fuses out.

3. Check that the circuit breaker of the power supply system to which the analyzer is connected
is not cut off.

11.6.3 Anomalous Measurement Results


Analytical results are noticed by error flags or unexpected results.There are following cases in which
trouble shooting of the analyzer is required:

1. Error flag is set to the calibration results.

2. Error flag is set to the measurement results of QC sample or normal sample.

3. The measurement results of QC sample are out of range of judgment criteria. Investigate which
situation shown below is applicable to the error in the measurement results of calibration, QC
sample or normal sample. Based on the investigation, further check may be requested.

4. The resultant values obtained from measurements of a specific method are high for all
samples.

5. The resultant values obtained from measurements of a specific method are low for all samples.

6. Erroneous results are randomly derived from the measurement.

7. Two or more anomalous measurement results are observed.


a) From all methods
b) Or randomly

11.6.4 Check for Preparation of Reagent, Calibrator or QC Sample


Perform the following checks in order to track down the cause for high, low or random resultant
measurement results. When a reagent, calibrator or QC sample is prepared, read the respective
statement of virtues carefully and follow its instruction.

1. Preparation of reagent.
a) Was there any change of the reagent?
b) Is the term of validity of the prepared reagent still valid?
c) Was the reagent prepared according to the correct procedures?
d) Was the reagent prepared using fresh, non-bacteria contaminated and DI water or
appropriate diluent?

2. Preparation of QC sample.
a) Was the volume used for preparation correct?
b) Was the sample preserved as recommended?

EM 200
Maintenance 11-9

c) Is the term of validity of the sample still valid?


d) Was the sample prepared using a pipette calibrated in terms of volume?
e) Is the term of validity of the sample lot still valid?
f) Was the sample prepared using appropriate diluent?

3. Preparation of calibrator.
a) Was there any change of the lot number?
b) Was the calibrator prepared using volume correctly?
c) Was the calibrator preserved as recommended?
d) Is the term of validity of the calibrator still valid?
e) Was the calibrator prepared using a pipette calibrated in terms of volume?
f) Was the calibrator prepared using appropriate diluent?

Further checks are requested to track down the cause referring to the following lists after the above
checks have been completed.

11.6.5 High Resultant Values from a Specific Method for all Samples

Sr. No. Cause Corrective action

1 Incorrect calibration results. Check the preparation of the calibrator.


Check that the calibration settings are correct.
The calibration is performed again if necessary.

2 Too high inside temperature of RCT Check the temperature shown in the Service
unit. Check > Temperature > Read.
Call for service at our customer service
department when the indicated temperature
deviates from the specified value of 37 ± 0.2ºC.

3 Improper preparation of reagent. Check the preparation of the reagent.

4 Improper preparation of calibrator. Check the preparation of the calibrator.

11.6.6 Low Resultant Values from a Specific Method for all Samples

Sr.No. Cause Corrective action

1 Expiration of the term of validity of reagent. See the statement of virtues that comes
together with the reagent kit for its stability.

2 Improper preparation of reagent. Check the preparation of the reagent.

3 Improper preservation of reagent. See the statement of virtues that comes


together with the reagent kit for its proper
preservation method.

4 Too low inside temperature of RCT unit. Check the temperature shown in the Service
Check > Temperature > Read.
Call for service at our customer service
department when the indicated temperature
deviates from the specified value of 37 ±
0.2ºC.

EM 200
11-10 Maintenance

5 Improper preparation of calibrator. Check the preparation of the calibrator.

6 Excessive volume of reagent dispensed. Check if there is any leakage or drip at


junction of reagent sampling system.

11.6.7 Randomly Derived Erroneous Measurement Results

Sr.No. Cause Corrective action

1 Fibrin clots formed on specific sample tube or Clean the SPT nozzle.
sample cup.
2 Insufficient water or solution supply from Check if the tip of water or solution
respective external tank. tube is positioned below the water or
solution level. Call for service at our
customer service department in case
of trouble.
3 Insufficient stirring. Check if the stirrer rotates in the
center of cuvette and at the correct
speed.

11.6.8 Anomalous Resultant Values from all Methods for a Sample

Sr.No. Cause Corrective action

1 Improper preparation of reagent. Prepare newly the reagent referring to the


statement of virtues that comes together with
the reagent kit.

2 Expiration of term of validity, Prepare newly the reagent referring to the


contamination or paleness of reagent. statement of virtues that comes together with
the reagent kit.

EM 200
Part

XII
12-2 ISE Measurment (Optional)

12 ISE Measurment (Optional)


The ISE (Electrolyte Measurement System) measures the concentration of lithium, sodium,
potassium and chlorine of serum, plasma or diluted urine with the ion electrodes.

It is placed on the left side of the analyzer. See section Ion Selective Electrodes.

All waste liquid are discharged into the external tank for high concentration waste liquid.

The module is completely self-contained. All the sample and calibrant positioning within the module
is controlled by an integral microprocessor, which assures reliable electrode operation and maximum
lifetime. The electrolyte measurement system’s microprocessor applies proprietary mathematical
algorithms to electrode output voltages, converting them to clinical units of mmol/L.

See the detailed figure of ISE module.

EM 200
ISE Measurment (Optional) 12-3

See the following section for more details:

Technical Specification

Measurement Theory

Electrodes and Reagents Used

Urine ISE Dilution Rerun

Storage and Usage of the Reagents

Turning off the Power

Shutdown Procedure

ISE Calibration

Maintenance Schedule

Troubleshooting

Installing New Reagent pack

Error Message

12.1 Technical Specification

Sample type Serum, Plasma or Urine (Urine requires dilution)

Sample size 70 µl serum


140 µl diluted urine

Analysis time Serum – 35 seconds, including one point calibration


Urine – 40 seconds, including one point calibration

Throughput Serum – 100 samples per hour


Urine – 90 samples per hour

Power 24V DC, 1.0A (SMPS, four channel ISE)

Module Size 161 mm high x 65.5 mm wide x 98.6 mm deep

EM 200
12-4 ISE Measurment (Optional)

Reagent Pack Calibrant A, Calibrant B


includes

Other Reagents Cleaning Solution, Urine Diluent

Operating Ambient 15°C - 32°C


Temperature

12.2 Measurement Theory


The electrolyte measurement system measures Sodium, Potassium and Chloride ions in biological
fluids using ion selective electrode technology.

A diagram of the electrode measurement system.

The flow-through electrodes use selective membrane tubing, specially formulated to be sensitive to
the respective ions. The potential of each electrode is measured relative to a fixed, stable voltage
established by the double junction Silver/Silver-chloride reference electrode. An ion-selective
electrode develops a voltage that varies with the concentration of the ion to which it responds. The
relationship between the voltage developed and the concentration of the sensed ion is logarithmic, as
expressed by the Nernst equation.

E = the potential of the electrode in sample solution


Eo = the potential developed under standard conditions
RT/nF = A temperature dependent “constant”, termed the slope
log = Base ten logarithm function
α = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution.

EM 200
ISE Measurment (Optional) 12-5

12.3 Electrodes and Reagents


Reagents used in the ISE Module:

Four reagents are used to operate the ISE module:

Calibrant A: It is used in both two-point and single-point calibrations for serum sample analysis.
Calibrant A is pumped into the sample entry port by the Calibrant A pump and then positioned in
front of the electrodes by the waste pump. Calibrant A solution is also used for Pump and Bubble
Calibration.

Calibrant B: It is used in two-point and single-point calibrations for urine sample analysis. Calibrant
B is pumped into the sample entry port by the Calibrant B pump and then positioned in front of the
electrodes by the waste pump.

Cleaning Solution: It is used once a day to prevent protein buildup on the electrodes and fluid path.
It must be used more frequently if the ISE Module performs greater than 50 sample measurements
per day. 100 µl of cleaning solution must be aspirated by the host analyzer from a sample cup on the
host analyzer and dispensed into the sample entry port. The sample cup must be covered to
eliminate evaporation.

Urine Diluent: It is required for the urine samples. Urine samples are diluted on-board by 10 times (1
part sample to 9 parts urine diluent) to perform urine measurement. The operator must keep the urine
diluent on the Reagent Tray

12.4 Urine ISE Dilution Rerun


Urine ISE sample should be Re-run with different Dilution ratio (increase / decrease Sample volume),
based on the Result flags in the order of K, Na then Cl.

The ISE Urine sample is performed with 10X dilution during its first run. During ISE-rerun, the 3X and
15X dilutions may be performed, depending upon the flag attached to the result (based on increased
or decreased sample volume).

On receiving the result, the test will go for rerun on the following conditions

1. If the sample result is attached with PANH flag, then sample will go for rerun with normal dilution
that is 1:9 (10X). If the sample result is attached with RANGH flag, then the sample will go for
rerun with decreased sample volume that is 1:14 (15X) dilution.

2. After receiving the result for the sample replicates, if both the replicates are attached with different
flag that is RANGH (requiring decrease rerun) and RANGL (requiring increase rerun). But the
priority of RANGH is higher so this sample will go for a Re-run with decrease sample volume. The
number of replicates sent to Rerun will be the same as number of replicates sent during the 1st
(original) determination.

The software will display re-run result (after applying the volume
correction) for only those tests having flags that required re-run. The
Attach Rerun Flag (“#”) and Volume Increase/ Volume Decrease Flag (“V-
I”/ “V-D”) will be displayed after correcting the results. Flags H, L, PANH,
PANL , RANGH and RANGL will be applicable to ISE results.

12.5 Storage and Usage of the Reagents


1. Store all solutions in a dark and cool place at room temperature.

EM 200
12-6 ISE Measurment (Optional)

2. Don't preserve the reagents such as or cleaning solution once they are dispensed to sample
cup.

3. Don't use the expired solution.

4. When opening new bottle for a solution, don't mix remaining solution from the previous bottle
.
5. Reagent Pack has one month of on board stability

12.6 Turning Off the Power


As Calibrant-A and Calibrant-B is automatically dispensed into ISE unit every 30 minutes to prevent
electrodes from drying out; it is not recommended to turn off the main power supply of the analyzer.
Switch off only the analyzer at the end of the day. This will keep the above function activated
.
When the Calibrant remains in fluid path for over two hours without flowing, the Na ion from reference
electrode can reach Na electrode and saturate the membrane resulting in effected Na measurement.

When the power to the analyzer needs to be turned off for a reason such as maintenance, follow the
procedure below to purge Calibrant-A solution in the path. Also refer to the procedure when turning
off the power for more than several hours, as it requires storage of the electrodes

12.7 Shutdown Procedure


Preparing the ISE Module for Storage

1. If the laboratory plans to store the ISE module for a period greater than one week, during
which the analyzer will not be connected to power, the following steps should be
performed.

2. Before removing the electrodes, they should be cleaned using the cleaning solution and
then running 3 Purge A cycles from the Maintenance > ISE.

Reference, Na+ and Cl- Electrodes

1. Depress the compression plate and remove all electrodes, including the reference electrode
from the ISE Module.

2. Place the Na+ and Cl- electrodes into individual sealed bags.

3. Reinsert the Reference Electrode flow path line with yellow flag, if available, and then put
into individual sealed bags.

K+ and Li+ Electrode

1. Aspirate a small volume of Calibrant A from the top port of the reagent pack into a syringe
fitted with a blunt needle.

2. Inject sufficient Calibrant A into the lumen of the K+ and Li+ electrodes until fluid fills the
lumen.

3. Cover both ends of the lumen (both sides of the K+ and Li+ electrodes) with tape to hold
the Calibrant A in place.

4. Insert the K+ and Li+ electrodes into a sealed bag.

Reagent Pack

EM 200
ISE Measurment (Optional) 12-7

1. Remove the Reagent pack from the analyzer and discard it.

Analyzer Tubing

1. Remove all the fluidic tubing and thoroughly rinse with DI water.

Analyzer Re-activation

Remove all electrodes from the sealed bags.

Remove tape from K+ and Li+ electrode

If necessary, soak the reference electrode in warm water until the lumen of the electrode
has been cleared of salt build-up.

Install electrodes into the ISE Module.

Connect new reagent pack to the ISE Module.

Use Prime Cycles to prime the Calibrants.

Calibrate analyzer.

12.8 ISE Calibration


Following to perform the ISE unit calibration:

1. Install the reagent pack and connect it to the ISE module. If the reagent pack is already in
place, shake it gently.

2. Pour the cleaning solution into the sample cup and place on the specified position of the
standard sample tray.

3. Go to the Maintenance screen from the main menu and click ISE ON button.

4. Select PURGE A and click START

On clicking, the ISE Module pumps Calibrant A from the reagent pack and dispenses it into
the sample entry port to wash out the electrode flow path. Repeat the procedure if required.

5. Select PURGE B and click START.

On clicking, the ISE Module pumps Calibrant B from the reagent pack and dispenses it into
the sample entry port to wash out the electrode flow path. Repeat the procedure if required.

6. Select PURGE A and click START.

On clicking, the ISE Module pumps Calibrant A from the reagent pack and dispenses it into
the sample entry port to wash out the electrode flow path. Repeat the procedure if required.

7. After completion of purge cycles, select CLEAN, and then click START. On clicking, the
analyzer dispenses cleaning solution and Calibrant A in the sample entry port during the
cleaning process.

8. After cleaning cycle is over, perform 6 to 8 PURGE A cycles. Now the system is ready for

EM 200
12-8 ISE Measurment (Optional)

calibration.

9. Select CALIBRATION and click START

This command is used to calibrate the electrodes of the ISE Module. The ISE Module then
cycles Calibrant B and Calibrant A solutions in front of the electrodes and measures the
millivolt output of the electrodes for each of the respective solutions.

These millivolt readings are then used to set up a relationship between sample concentration
and electrode millivolt output. The change in millivolts per change in concentration is the
slope of the electrode. The slope of the electrodes is reported in mv/dec (millivolts per
decade change in concentration), and should be within the following limits:

Li+ 47-64 mV/dec

Na+ 52-64 mV/dec

K+ 52-64 mV/dec

Cl- 40-55 mV/dec

After the calibration process is completed, electrode calibration slopes are displayed on the
right side of screen. If any error occurs during the calibration process, the error code is also
displayed in the error message grid. If the slopes are within range then a box with green
color is displayed. If slopes are out of range then a box with coral (deep pink) color is
displayed. The previous calibration details with date and time along with the slope values can
be viewed. To view them select CALIBRATION, and then click SHOW REPORT.

If the electrode calibration slopes are in the acceptable range, the electrolyte measurement
system is ready for the sample analysis.

For Serum samples 70 µl and for Urine 140 µl (10 times diluted with urine diluent) of sample
is required for the electrolyte measurement.The slope is defined as:

Where CA = Calibrant A concentration in mmol/L


CB = Calibrant B concentration in mmol/L
EA = ISE Potential developed in Calibrant A solution in mV
EB = ISE Potential developed in Calibrant B solution in mV

10.To perform pump calibration, select PUMP CALIBRATION and click on START.

Once the process is completed successfully, values for all the 3 pumps CAL A, CAL B and
Waste are displayed. If the values are between proper range, then calibration is displayed
OK with green colored box else it is displayed NOK with red colored box.

11.To perform bubble calibration, select the option BUBBLE CALIBRATION and click on START
button. Calibrant A solution is dispensed in the sample port. Bubble calibration allows the
module to reestablish a baseline for detecting air-liquid interface. It can be used as a
diagnostic tool to see if the bubble detector is functioning properly. If the process is
successful without any error it s displayed OK with green colored box else it is displayed NOK
with red colored box.

EM 200
ISE Measurment (Optional) 12-9

12.9 Maintenance Schedule


The electrolyte measurement system has been designed to require very little operator maintenance.

The only daily maintenance required is to run the Cleaning Solution after the last sample of the day.
All other parts and expendables are replacement items (see schedule below).

Recommended Maintenance/Replacement Schedule (low volume


user).
Pump Cassette 9 months
Na+ Electrode 6 months
K+ Electrode 6 months
Cl- Electrode 6 months
Li+ Electrode 6 months
Reference Electrode 6 months
Reagent Refill reagent as required by testing needs

Recommended Maintenance/Replacement Schedule (greater than 100


samples/day).
Pump Cassette 6 months
Na+ Electrode 10,000 samples
K+ Electrode 10,000 samples
Cl- Electrode 10,000 samples
Li+ Electrode 10,000 samples
Reference Electrode 10,000 samples
Reagent Refill reagent as required by testing needs

12.10 Troubleshooting

Symptom Cause Corrective actions

System does No power


not respond
Communication failure Turn off power, reapply power.

RS232 cable is disconnected or Reconnect or replace cable.


damaged

ISE Module connector has been Replace board.


damaged

Component failure on board Replace board.

Low Slope Na+ Misalignment of electrodes Remove electrodes. Inspect o-rings.


or K+ <52 mV/ Reassemble properly.
decade Cl-
<40mV/
decade, Li
+<47mV
mV/decade or
High Slope Na
+,

EM 200
12-10 ISE Measurment (Optional)

Symptom Cause Corrective actions

K+, or Li+>64 Calibrator solutions Replace Reagent pack


mV/decade
Cl- >55 mV/ Electrode (low slope) Replace electrodes.
decade
Air bubble on reference electrode Remove electrode, tap to dislodge
membrane bubble, replace, and recalibrate

Reference electrode Replace reference electrode and


retest

ISE Module or Fluid temperatures Change ISE Module location if


exceed 320 C (high slope) ambient temperature is too great.

Noise Error Electrode. Replace problem electrode and


Flag Single recalibrate
electrode
Electrical noise spike from a) Find source of spike and eliminate.
environmental source b) Check grounding of ISE module.

Component failure on ISE Module board Replace Board.

Noise Error Reference Electrode Replace reference electrode and


Flag recalibrate
Multiple
electrodes Electrical noise spike from a) Check for electrical noise
environmental source coincident with activation.
b) Check grounding of ISE Module

Component failure on ISE Module board. Replace board.

Drift Error Flag May occur when new electrode Purge Purge the Cal A and recalibrate the
the Calibrant A is installed. If the module.
Single
electrode is new it may initially drift as it
Electrode
rehydrates over the course of 15
minutes

Electrode Replace the electrode and recalibrate.

Drift Error Flag May occur when new electrode or Purge the Calibrant A and recalibrate
reagent pack is installed on system. the ISE Module
Multiple
Electrode
Reference electrode Replace reference electrode and
recalibrate

Electrical spikes from environmental a) Find source of spike and eliminate


source
b) Check the grounding of ISE
Module.

Component failure on ISE Module board Replace the board

Air in Sample Insufficient sample pipetted into the ISE Host instrument must deliver 70µl.
Module sample entry port. Increase dispensed sample volume.

EM 200
ISE Measurment (Optional) 12-11

Symptom Cause Corrective actions

Fluid leaks. Determine source of leak and resolve

Sample not positioned properly. a) Electrode not seated properly.


Remove electrode. Inspect o-rings and
reassemble.
b) Replace pump tubing.

Pump tubing obstructed. Replace pump tubing.

Bubble in sample. Host must deliver sample free of


bubbles.

Air in Sample Cal B and Cal A are segmented with air a) Electrodes are not properly seated
and Cal A or compressed. Check compression
plate, spring and seal. Remove and
reassemble electrodes.

Fibrin or salt is plugging the electrode a) Use Cleaning procedure for module.
flow path.
b) Remove electrode and clean or
replace electrode with plugged flow
path. Reinstall electrodes and
recalibrate.

Bubble detector is malfunctioning Replace bubble detector.

Waste pump is malfunctioning Replace Waste Pump.

Dirty sample cup Clean with cotton swab and DI water.

Air in Cal B Cal B and Cal A are segmented with air a) Electrodes are properly seated.
and Air in Cal Check compression plate, spring and
A seal.
b) Ensure that all electrodes and o-
rings are properly installed.
c) Ensure tubing between reagent
pack and sample entry port is
connected properly.
d) Replace tubing between reagents
pack and sample entry port.
e) Reagent low or out.
f) Use Cleaning procedure for module.

Fibrin or salt is plugging the electrode a) Use Cleaning procedure for module.
flow path.
b) Remove electrodes and clean or
replace electrode with plugged flow
path. Reinstall electrodes and
recalibrate.

Bubble detector is malfunctioning Replace bubble detector.

Waste pump is malfunctioning Replace waste pump

EM 200
12-12 ISE Measurment (Optional)

Symptom Cause Corrective actions

Bubble detector malfunction Replace bubble detector

Air in Cal A Calibrant A Replace reagent pack with new one,


prime and recalibrate

Tubing from reagent module is Reconnect or replace tubing.


disconnected, plugged or crimped

Calibrant A pump is not working properly a) Check electrical connections.


b) Replace pump tubing
c) Replace motor
d) Replace pump.

12.11 Installing New Reagent Pack


Perform the following instructions after installing new reagent pack:

1. Connect the new Reagent Pack on the analyzer.

2. Click on ISE ON button in the Maintenance screen. The software will detect the new pack
and perform priming (Prime A and Prime B) operation automatically till ISE module sends
OK status (air removed), maximum up to 10 times.

During this operation, the following error message may be displayed on the
error grid:

Air in Calibrant A. ISE tubing may be bent, closed or not attached or

Air in Calibrant B. ISE tubing may be bent, closed or not attached

3. This will help the user in detection of bended or closed tubing. In this case, correct the closed
or bent tubings and again perform the Prime A and Prime B commands manually through
the ISE Maintenance Commands.

4. Once the auto priming operation performed correctly, the lot number and expiry date of the
new reagent pack will be displayed on the Lot No. and Expiry Date along with the following
information

ISE Pack Installation Date

Lot Number

Expiry Date

Distributor code (This information is stored in the reagent pack’s dallas chip and not
visible to user)

Volume of Cal A and Cal B in full Pack.

EM 200
ISE Measurment (Optional) 12-13

The above information can also be checked through ISE Pack button available on the Status
Monitor screen. Perform calibration with the new reagent pack and check the values.

12.12 Error Messages


The following error codes with description will be displayed on the Maintenance Errors grid, if any
error occurred during the ISE operation.

Assembly Error Code Description Possible Corrective Actions


Failure

ISE ID ISE Pack - Reagent pack Change ISE Pack


Installation Date expired or
Mismatch. Inventory invalid
may not be Correct

ISE IE ISE Pack - Expired -- Change ISE Pack

ISE IL ISE Reagent Pack Required Change ISE Pack


Volume Low (Less volume
than 10% of Total insufficient
Volume)

ISE IN ISE Pack - No Dallas Dallas chip Ensure reagent


Chip absent connector properly
connected on Dallas chip

ISE IR ISE Pack - Dallas Dallas chip Change ISE Pack


Read Error absent

ISE IT ISE Pack - Time Out Dallas chip 1. Check ISE module
Occurred absent connection
2. Ensure reagent
connector properly
connected on Dallas chip

ISE IU ISE Pack - Unknown -- Change ISE Pack


Distributor

ISE IV ISE Reagent Pack Required Change ISE Pack


Volume Very Low volume
(Less than 3 Days insufficient
Sip)

ISE IW ISE Pack - Dallas No Dallas chip, Ensure reagent


Write Error date already connector properly
written connected on Dallas chip

ISE ISES* Air in Sample / Urine 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
2. Tubing
leakage

EM 200
12-14 ISE Measurment (Optional)

ISE ISEA* Air in Calibrant A 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
2. Tubing
leakage

ISE ISEB* Air in Calibrant B 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
2. Tubing
leakage

ISE ISEC* Air in Cleaner 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
2. Tubing
leakage

ISE ISEM* Air in Segment 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
2. Tubing
leakage

ISE P Error in Pump Cal 1. Required 1. Change ISE Pack


volume 2. Ensure proper tubing
insufficient
3. Check motor wiring
2. Tubing
leakage 4. Change motor

3. Motor
problem

ISE ISEF* No Flow 1. Motor 1. Check motor wiring


problem 2. Change motor
2. Tube choked/ 3. Replace Tubing
bent

ISE D Error in Bubble 1. Bubble Change ISE Module


Detector Detector
module problem

ISE R Dallas Read Error 1. Dallas chip Change ISE Pack


absent
2. Dallas chip
connection
improper

ISE W Dallas Write Error No Dallas chip, Ensure reagent


date already connector properly
written connected on Dallas chip

EM 200
ISE Measurment (Optional) 12-15

ISE ISET* Time Out Dallas chip 1. Check ISE module


absent connection
2. Ensure reagent
connector properly
connected on Dallas chip

EM 200
Contact Us
We welcome your feedback about the product. You can reach us at the following.

Address: Transasia Bio-medicals Limited, Transasia House, 8 Chandivali Studio,


Road, Andheri (East), Mumbai-400072, India

Phone: 022 - 40309000

Fax: 022 - 28573030

Website: www.transasia.co.in

Email: transasia@transasia.co.in

Transasia Bio-medicals Limited, Transasia House, 8 Chandivali Studio Road,


Andheri (East), Mumbai-400072, India

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy