User Manual For EM 200 - v2021.C03
User Manual For EM 200 - v2021.C03
User Manual For EM 200 - v2021.C03
for
EM 200
R
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obligation.
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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
Injury
Table of Contents
Foreword 12
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
EM 200
Contents 7
................................................................................................................................
10 Computer Specification 5-9
EM 200
8 Contents
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
EM 200
10 Contents
1 List................................................................................................................................
of Errors 8-2
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.
EM 200
Part
I
1-2 System Overview
1 System Overview
This section provides an overview of the analyzer and its main features.
Introduction
System description
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.
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
the screen.
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.
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
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
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.
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.
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.
EM 200
System Overview 1-7
1 Monitor
2 Keyboard
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
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.
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
EM 200
1-10 System Overview
Access panels to work on the internal and external parts of the analyzer.
EM 200
System Overview 1-11
2 Stirrer
Sample tray
Reagent tray
Reaction tray
Photometer unit
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
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.
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
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.
9 non-barcoded cups of 2 ml
The sample is aspirated by the Sample & Reagent Pipette Unit (SRPT) and dispensed into cuvettes
of the Reaction Tray Unit (RCT).
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
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.
The reagent bottles are available in two types. The type of usable reagent bottles are 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.
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:
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.
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
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.
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.
EM 200
1-18 System Overview
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:
When the batch run is manually terminated from Status Monitor by user
When the batch run terminated due to occurrence of any emergency error.
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
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.
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.
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.
EM 200
1-22 System Overview
Daily routine
Cleaning Can
ISE unit
1. The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.
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
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.
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.
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.
EM 200
1-24 System Overview
EM 200
Part
II
2-2 System Installation
2 System Installation
This section gives you the detailed explanation on installing analyzer.
Pre-installation
Installation
Read the necessary general safety guidelines before installing the analyzer for the first
time. See Safety Instructions for more details.
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:
Keep the analyzer out of the rain and any other water splash.
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.
Check the power supply frequency, voltage and current capacity (power
consumption).
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.
Electrical requirements
Floor requirements
Room lighting
External interferences
Proper ventilation
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.
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.
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).
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.
EM 200
System Installation 2-5
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.
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.
Verify and ensure a dust free environment for analyzer, this is a small but very important
consideration when installing the analyzer.
Room temperature should not vary more than 2°C per hour.
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.
EM 200
2-6 System Installation
Receiving Information
Accessories Checklist
This section describes you the basic guidelines or information on analyzer's receiving instructions
and warranty.
Receiving instructions
Warranty instructions
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.
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:
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
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.
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.
Printer
Computer etc.
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System Installation 2-9
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)
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
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2-10 System Installation
P. M. KIT (NEW) II
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2-12 System Installation
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:
Printer installation
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.
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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.
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2-14 System Installation
7. Place the respective tray lid over the Reagent Tray and Sample Tray.
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.
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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.
1. Unpack the USB cable from the accessories box, and connect its one end to the USB port of
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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.
5. Print a test page from the analyzer computer to confirm correct printing.
1. Unpack the Test Loader device,Test Loader stand and USB cable from the accessories as shown
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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.
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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.
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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
Read the necessary general safety guidelines before installing the softw are for the first
time. See Safety Instructions for more details.
3.2 Pre-requisites
Make sure that you should have the following pre-requisites before installing the software.
System configuration
Before installing the MultiXL software, make sure that your computer should have following
minimum system configuration.
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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.
Note that these are critical settings for the communication with the Analyzer.
Use the following steps for setting the regional and language options:
1. Select Regional Options tab, and define the following settings. See figure below:
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Software Installation 3-4
2. Select Languages tab, and define the following settings. See figure below:
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3-5 Software Installation
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.
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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.
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.
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3-7 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.
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Software Installation 3-8
6. Similarly, apply same settings to Power saver option. Repeat the step 3 to 6.
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.
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3-9 Software Installation
4. You must re-start the analyzer PC to turn on the user account control.
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.
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Software Installation 3-12
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3-13 Software Installation
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.
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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.
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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.
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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;
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3-17 Software Installation
4. You must re-start the analyzer PC to turn on the user account control
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.
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Software Installation 3-18
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3-19 Software Installation
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Software Installation 3-20
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3-21 Software Installation
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.
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
Upgrading MultiXL Software (to upgrade MultiXL from existing version to the new version)
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Software Installation 3-22
1. Insert the installation CD into the CD drive of your computer. On inserting the CD, the MultiXL
Installation screen will be displayed.
OR
OR
2. Click on Install MultiXL Application & Database link and follow the on-screen instructions.
OR
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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:
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Software Installation 3-24
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.
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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.
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Software Installation 3-26
Wait until the setup wizard is visible on the screen as shown below.
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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.
The installer will install the software in the default location C:\Program Files\MultiXL.
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Software Installation 3-28
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.
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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.
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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:
The windows key (left and right) will be disabled from the keyboard. Logging of MultiXL
start and shutdown events (for internal use).
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.
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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.
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
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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.
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.
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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).
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Software Installation 3-34
To check the installed software versions, go to Service Check screen, right click
on the Misc Commands button, and choose Software Version option.
Team Viewer is used to access analyzer computers, which makes it an ideal solution for Remote
Monitoring and Trouble Shooting purposes.
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.
Installation Procedure:
1. On insertion of CD on Auto-play, MultiXL Installation screen will be displayed with the option to
install Team Viewer.
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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.
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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.
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.
Upgrade Software
Upgrade Database
Take a database backup through Utility > Backup, before proceeding with
software upgrade.
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3-37 Software Installation
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
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.
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Software Installation 3-38
Database can be upgraded to match the newer software version without deleting the database of the
existing version.
Upgrading Database
1. Click on the Run Database Utility link from MultiXL Installation screen as shown below.
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3-39 Software Installation
OR
1. Open the Database Utility folder from the software installation CD. Double-click on
DatabaseUtility.exe.
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.
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Software Installation 3-40
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,
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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.
Database backup
Change database
OR
1. Open Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.
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Software Installation 3-42
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.
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3-43 Software Installation
Before installation, you should take the backup of the database before deleting
or changing 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.
3. Click on DELETE DATABASE to delete the existing database. The following screen will be
displayed.
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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.
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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.
Or
1. Open Database Utility folder from the software installation CD. Double-click
DatabaseUtility.exe.
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.
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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.
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3-47 Software Installation
Now you can access the MultiXL application. (Refer section Accessing MultiXL Software for more
details)
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.
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.
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Software Installation 3-48
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:
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.
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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.
When starting MultiXL first time, the product login screen as shown below will be displayed.
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.
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.
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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.
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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.
Symbols Meanings
DO NOT TOUCH
BIOLOGICAL HAZARD
DANGER OF BURNS
BIOLOGICAL RISKS
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4-3 Saftey Information
Labels Places
Only qualified and trained personnel should use the analyzer and perform the procedures
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Saftey Information 4-4
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.
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.
Keep the analyzer out of the rain and any other water splash.
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.
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.
Reagent handling:
After unpacking the reagents, be sure not to allow dust, dirt or bacteria to come
in touch with the reagent.
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Saftey Information 4-6
Take care not to spill the reagent. If it spills, wipe it off immediately using a wet
cloth.
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..
Arm probe
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.
In the event of trouble in analyzer, do not troubleshoot by your own. You must
contact the authorized service personnel.
EM 200
Part
V
Technical Specification 5-2
5 Technical Specification
This section tell you the technical specification of the system in detail.
General specification
Sampling unit
Reagent unit
Reaction unit
Control unit
Data processing
Installation Condition
Computer 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.
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
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5-3 Technical Specification
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).
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).
Safety mechanism Vertical obstruction detection, Capacitance based liquid level sensing.
Item Description
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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
Pipetting mode Discharges set volume of sample into cuvette or the ISE module
(optional).
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
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5-5 Technical Specification
Item Description
Dead volume
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.
Item Description
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
The 1st step: Right after Reagent 1 and sample dispensing into
the respective cuvette
Item Description
Wavelength 8 Wavelengths: 340 nm, 405 nm, 505 nm, 546 nm, 578 nm, 600nm, 660
nm and 700 nm.
OD range OD 0 – 3.
Light path calculated as 10 mm.
Resolution 0.0001 OD
EM 200
5-7 Technical Specification
Cell blank correction Corrected by water blank measured after cuvette washing.
Item Description
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
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.
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.
Item Description
Sample types Serum, Urine (urine diluted 10 times on board for first determination).
EM 200
5-9 Technical Specification
Item Description
Drainage Used sample (concentrated waste solution) and washed sample (diluted
waste) are to be drained separately.
Item Description
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.
Screens
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
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.
EM 200
User Interface 6-5
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
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.
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.
Clear Schedule
Work List
Copy Tests
Mask Tests
CEC
EM 200
User Interface 6-7
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.
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.
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.
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.
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.
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 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.
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 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.
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
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).
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.
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.
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.
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.
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.
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.
EM 200
User Interface 6-15
is not fed, default normal values are used to issue H and L flags.
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
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.
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.
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)
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.
EM 200
User Interface 6-17
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;
This section tell you how to clear CEC schedule for a patient.
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.
7. Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection.
6.3.1.7.3 Edit
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6-18 User Interface
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.
EM 200
User Interface 6-19
Test Details
Reference Range
Test Volumes
Copy Test
When you see some of the parameters in the Test Parameters screen disabled,
please switch on the analyzer.
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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.
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
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.
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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:
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.
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
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 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.
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
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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.
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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.
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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.
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.
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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.
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.
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.
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Upload Test
Using UPLOAD TEST button, the parameters of the selected test gets uploaded.
Default tests parameters are updated through ENC file format only.
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.
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
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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.
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.
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
Follow the steps to use Test-specific Special Diluent for an Open / Closed Channel Photometric
Test:
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4) Define different test-specific diluents to be used during run and click Save.
8) Also by using Special Diluent > Click , user can edit special diluent for test as shown in
below screen.
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9) Select the test and Click EDIT. Select the Special Diluent Name from drop down list as show
below
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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.
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.
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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).
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.
See also:
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.
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This option will be disabled if the curve type for the test is set as K-Factor.
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.
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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.
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.
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Dilution Ratio Specify the dilution ratio for normal, increase and decrease sample volume.
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.
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.
Copy Volume button is used to copy the volumes from current sample type to other sample type(s)
of the selected test.
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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.
Tick this option, if you want to pre-dilute standard/calibrators using normal dilution ratio of Sample.
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.
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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
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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.
This button is used to copy the reference ranges from current sample type to other sample types.
Multiple sample types can also be selected.
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
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.
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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.
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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
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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
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Scheduling Standard
Scheduling Controls
Scheduling Blank
Scheduling Calibrators
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.
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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.
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.
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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.
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.
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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.
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.
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.
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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.
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8. Click on SCHEDULE.
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.
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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.
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.
Tests
Selective
Curve Type
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Selective: Tick this check-box to schedule Selective Calibration (perform only blank to
derive the calibration curve) 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.
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.
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Test(s) scheduled with Selective Calibration are marked with Asterisk (*)
symbol under column Pos.
The MultiXL will prompt a message if the required Blank and Standards/
Calibrators are not scheduled.
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.
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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’.
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10.On clicking OK, the tests will be added in the selected positions as shown in the following
figure.
11.Click on SCHEDULE.
The MultiXL will prompt a message if the required Blank and Standards/
Calibrators are not scheduled.
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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;
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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.
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
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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.
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.
Parameters Description
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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
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.
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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.
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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.
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.
Enter remarks
The user should either rerun the controls again or recalibrate the test and run the controls.
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To open the screen, go to QC/Calibration > QC Data screen. The following screen is displayed as
shown below:
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.
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.
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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,
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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)
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.
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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.
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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.
: 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.
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mean is calculated according to the user required QC points and displayed in lower left
corner of the screen. See the figure 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.
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Use GRAPH button to view graph with new lab mean or manufacturer mean, as
appropriate.
EXPORT: User can click on EXPORT button to export the data to an excel sheet.
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.
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.
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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.
e. Mean – Mean of Daily averages if date range is selected Or Mean of all the replicates for
the single date selected.
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.
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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).
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9. Un-check the Show Date check box, if you do not want to display the date on the marked
points.
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.
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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.
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.
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3. Enter the appropriate Reagent name, Reagent Code, and Reagent Type.
In the closed system, user is allowed to define or add reagent code only in
the permitted range, otherwise system will prompt a message.
On saving the details, the reagent will be added in the list of reagents as shown in the
following figure.
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6. Double click on the Reagent name from the list of reagents. The selected reagent will be
displayed. See the following figure:
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8. Now enter the manufacturer name from the manufacturer drop-down list. See section
Manufacturer for adding manufacturer name in the list.
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.
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3. Click EDIT.
4. After editing the details and click SAVE. The details will be saved.
Following table gives a brief explanation on the different fields in the grid.
Parameters Description
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.
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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.
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.
Defining 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.
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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.
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5. Select the Manufacturer name. See section Add Manufacturer for more details.
8. On clicking, the blank will be saved and displayed on the Consumable screen, when the
Blank is selected.
Defining 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.
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5. Select the Manufacturer name. See section Add Manufacturer for more details.
10.On clicking, the blank will be saved and displayed on the Consumable screen, when the
Standard is selected.
Defining Calibrators
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.
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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.
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5. Select the Manufacturer name. See section Add Manufacturer for more details.
10.On clicking, the calibrator will be saved and displayed on the Consumable screen, when
Calibrator is selected.
Defining Controls
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.
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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.
5. Select the Manufacturer name. See section Add Manufacturer for more details.
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.
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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.
5. Select the Manufacturer name. See section Add Manufacturer for more details.
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.
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5. Select the Manufacturer name. See section Add Manufacturer for more details.
User is not allowed to define system solutions (wash, diluents, etc.) for reserved
reagent codes.
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.
Downloading Consumables
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.
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.
At least one consumable lot should be selected to download.
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
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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.
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.
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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.
The Status Monitor screen has four main options, each of which shows the state of a particular part
of the system.
SAMPLE TRAY
REAGENT TRAY
REACTION CURVE
BARCODE SCAN
Pre-Run Options
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Work List
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.
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.
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.
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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.
When the batch run is started, each samples will go through number of states will be represented in
the following color codes:
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
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temperature is highlighted in green background color. When the temperature falls out of the range,
then it is highlighted in red color background.
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
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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.
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.
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.
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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.
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.
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.
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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
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.
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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 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.
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“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.
The Reagent Barcode Scan button will be disabled if the option Reagent
Barcode is unchecked in Settings > System Parameters screen.
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.
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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.
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
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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.
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.
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.
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:
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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.
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:
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.
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.
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
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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.
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.
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:
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.
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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.
Work List screen displays the sample and reagent details for the scheduled run. Work List screen
will be displayed if:
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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.
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
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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.
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.
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
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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.
lf the user wants to add a new barcoded reagent (Continuous Reagent Loading), the following
procedure should be used:
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;
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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.
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If the user wants to add a new barcoded sample (Continuous Sample Loading), the following
procedure should be used:
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.
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.
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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
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
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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.
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.
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.
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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.
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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
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Open channel tests can also be loaded using special cards which may be
available for purchase from manufacture in special circumstances.
2. Select the appropriate test for which the online calibration is required.
Use SET ONLINE CALIBRATION option, if you want to select multiple tests.
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When the batch run is started, the system will perform the following operations.
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
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.
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. 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
. 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.
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.
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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.
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.
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.
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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.
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.
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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.
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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.
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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.
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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.
6.3.7.4 Consumables
Consumable screen is used to search the consumable information.
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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.
6.3.7.5 Tests
Test screen is used to search the tests parameter details according to the specified inputs.
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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.
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.
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Patient Reports
Result Reprint
Test Statistics
Calibration Trace
Calibration Monitor
Error Log
Reaction Curve
Other
Sample ID wise
Test wise
Doctor wise
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Patient ID wise
See also:
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
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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.
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
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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.
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.
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Multi Column
This format facilitates to print patient results in two-columnar format, like newspaper. See
figure below.
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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.
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Graphical
Patient results and defined reference ranges are graphically represented in this format. Refer to
following figure for example.
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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.
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.
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.
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Abnormal Results: If the user selects this option, then Results with flag are displayed.
After selecting the required parameters, click SHOW to display the results.
See also:
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.
Parameters Description
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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.
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.
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.
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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.
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See also:
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
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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.
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.
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.
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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.
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.
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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.
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2. Select the operation (All, Run, Service, Maintenance, or Host operations) during which the
errors occurred.
4. Use Error Code drop down list is used to filter the records as per requirement.
Error Code – Displays the error code to identify the type of error occurred.
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
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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.
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).
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.
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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.
The time course display also contains the following details regarding that reaction curve.
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.
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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.
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.
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6.3.8.8 Other
Other option gives the report of Reagent Consumption,ISE Calibration,Reagent Bottle History and
Pack Details
Use SHOW to view the data over the selected date range.
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.
ISE Calibration
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Select ISE Calibration radio option. This will displays the calibration details on the screen.
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.
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In Bottle no. column, the first three digits denote the Lot no. whereas the next
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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.
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.
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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.
Area
Doctor
Analyst
Laboratory
Mfg
Reference Range
Unit
Calculation Formula
Instrument
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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:
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.
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See also:
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.
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See also:
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.
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See also:
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.
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See also:
There is always a default row present marked with ** sign. This row can’t be deleted, it can only be
selected.
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See also:
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.
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See also:
Commonly (or frequently) used calculation formula are provided as default list. New formula can be
added to list, as required.
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See also:
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.
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See also:
1. Select the Unit conversion > from Master > there are radio buttons >Test and Calculated Item
and Check box for General > select TEST tab.
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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.
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.
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.
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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.
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6.3.10 Utility
Utility allows user to perform the following operations:
Reagent Positions
Backup
Offline Results
Recalculate
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.
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Clear position :Clear Position used to clear the defined reagent positions on the reagent tray. There
are two sub options:
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
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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.
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.
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
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5. Select the scanned reagent bottle position from which reagent to be transferred to tube.
6. Click Transfer To tube. Reagent position box appears.
10.Click OK. Click Reagent position, reagent which is transferred to tube now appears in bottle
type as Tube.
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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.
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.
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, 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).
System will track reagent volume used in tube for new as well as used reagent bottles.
Tube is not allowed for discarded reagent bottle, until next barcoded bottle is scanned.
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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 Operations
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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
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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.
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.
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).
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
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.
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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;
5. To Restore the files user needs administrative rights otherwise Restore button will remain
6. Run Database Utility to restore the backup of database. Refer section Database Utility Options
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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.
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
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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.
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Results of the test(s) having flags for Sample/Reagent absent cannot be re-
calculated.
Sample ID textbox will be disabled if option Calibration or Control radio button is selected.
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:
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.
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.
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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
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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.
a. Manually calculate the Dilution Calibration Factor (DCF) using 5x dilution as shown below:
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.
f. MultiXL will multiply the results of dilution, any dilution for 2x to 150x, by this factor and
then result is declared.
Sample Tray
Initialize: This option is used to initialize the Sample Tray. (Position # 1).
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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
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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.
Make sure the RCT Cuvettes are aligned before executing this command.
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
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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.
This option is used for checking the Valve operations for ARM Trough, ARM PROBE and Stirrer
Trough.
ARM Probe Clean Valve: Turns ON or OFF the ARM Probe Clean Valve.
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:
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
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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.
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
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.
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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.
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;
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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.
Once the Embedded Software is uploaded successfully, a prompt for Restarting the analyzer
appears on the screen as shown below;
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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.
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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.
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6.3.12.1 Maintenance
Maintenance is used to perform the routine maintenance of the analyzer.
Wash
ISE Unit
Auto Maintenance
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.
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.
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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.
4. The continuous online update of voltage and absorbance takes place and is displayed on the
screen.
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
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.
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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.
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.
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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).
4. On clicking, a message box will be displayed indicating the user for placing cleaning
solution.
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.
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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.
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.
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).
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Use the following procedure to carry out the dead volume 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.
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.
If the calibration is successful then the values are automatically stored in the software.
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.
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Once the calibration process is completed then it is automatically stored in the software.
Default Calibration
The following steps should be done to reset the Dead Volume Calibration to Default:
2. Select the container type from the list for which the Dead volume calibration needs to be
reset.
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.
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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
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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.
The appropriate status (Partial, Failed or Pass) will be displayed on the basis of following
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conditions:
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.
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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.
This command is used to display last calibration values for the Na, K, Cl, and Li.
ISE ON
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
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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.
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.
This operation can be initiated any time from the Auto Maintenance from the Maintenance screen:
See the following procedure to perform auto maintenance and shutdown operation manually:
1. Select START-UP.
2. Click START.
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Startup
1. Priming of laundry unit and SRPT probe with DI water for one minute (automatic step).
1. Select SHUTDOWN.
2. Click START.
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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.
Shutdown
2. Analyzer initialization.
6. Internal and External probe cleaning with DI water in trough for 3 times.
9. Shutdown
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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.
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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.
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
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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.
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).
Status indicates the status of activity, such as successful, unsuccessful, and performed.
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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
System Parameters
Carryover Pairs
Test Sequence
Re-run Flags
User Rights
Host Settings
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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.
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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.
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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 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.
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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.
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.
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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.
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.
Using this screen, you can define the forbidden pair for a particular chemistry.
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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.
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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
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.
In Carryover Pair screen, DELETE button will be disabled for default loaded
carryover pairs.
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:
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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
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.
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.
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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.
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.
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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.
This option is used to set the sequence of test and calculated items to be printed on the patient
reports.
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This option is used to set the sequence of profile to be printed on the patient reports in Profile format.
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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.
Guest is the default user name with all user rights. See the following figure.
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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).
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CHECK CONNECTION: This button is used to check the communication between Host and analyzer
PC.
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.
When this option is selected, the patient results, which are generated during the batch run will be
automatically sent to LIS.
For any test containing "µ" in unit, "µ" gets transmitted as "u" to LIS.
When this option is selected, the control results, which are generated during the batch run will be
automatically sent to LIS.
When this option is selected, system will accept redo test action received from LIS and re-do the
tests for that sample.
When this option is selected, patient results sent to LIS will be displayed with associated sample
position number and disk number.
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)
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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.
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).
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.
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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:
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.
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User Interface 6-219
For archiving and restoring patient data, the Archive option will appear on the main menu as shown in
the following figure.
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.
Archiving Data
Observations
1. Click on the Archive option from the main menu. following screen will be displayed
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6-220 User Interface
3. Select the Archive Patient Data option, and click OK,the archive process will start and the
status will be displayed as shown below
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User Interface 6-221
4. After completing the archive process, a message “Archived data successfully” will be
displayed on the screen.
1. Click on the Archive option from the main menu. Following screen will be displayed.
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6-222 User Interface
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”.
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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:
Other main menu screens are not accessible for the user except the following screens:
Search
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6-224 User Interface
Reports
Archive
Shutdown
Shut Down
Before system shutdown, a progress bar may be displayed on the screen which
indicates that the archive operation is in progress.
It is an automatic operation, which will be performed only after every seven days
when system is shutting down.
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User Interface 6-225
performed.
After completing the Water save activates, it will shutdown the MultiXL application, PC, and Analyzer
automatically.
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.
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:
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6-226 User Interface
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;
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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.
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.
Daily start-up
Daily routine
Also, this section tells you the basic sequence of operations during the sample analysis. See the
following sections for more details:
Sequence of operations
The reaction is read at defined time interval of 18 seconds to obtain their optical densities.
EM 200
7-3 Operation
EM 200
Operation 7-4
Confirm that:
The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.
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7-5 Operation
1. The cleaning wash solution should be filled with sufficient wash 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.
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:
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 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
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.
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.
The MultiXL software will start automatically and the login screen is displayed.
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.
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7-7 Operation
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.
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.
Item Description
EM 200
Operation 7-8
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
Barcode printing
Range
Positioning of barcode label The position is such that there is no obstacle between the
barcode printing area and the bar code reader.
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.
Necessary reagents and wash solutions for analysis are placed on the reagent tray.
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.
Following sections will show you how to defnin sample and reagents through MultiXL.
Defining Samples
Defining Reagents
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Operation 7-10
Refer section:
Barcoded
Non-Barcoded
7.3.5.1.1 Barcoded
1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).
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.
6. Open Utility > Reagent Position screen, and define the necessary reagents required for
the test.
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7-11 Operation
7.3.5.1.2 Non-Barcoded
1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).
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.
6. Open Utility > Reagent Position screen, and define the necessary reagents required for the
test.
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.
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7-13 Operation
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
1. Double click on the Reagent name, to select from the list of reagents.
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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.
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.
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Operation 7-16
1. To edit the reagent details, go to Consumable screen, select the Consumable Type as
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7-17 Operation
3. Double click on the desired reagent name from the list of reagents.
5. On clicking, the following screen will be displayed for editing the details.
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 -
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.
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Operation 7-18
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.
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.
On clicking, the available reagents will be scanned and the barcode information is
registered and displayed on the screen.
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7-19 Operation
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.
The Reagent Barcode Scan button will be disabled if the option Sample
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Operation 7-20
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
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:
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7-21 Operation
4. Select the required position to be defined, from the Position list or select the required position
from the screen.
7. Select the appropriate bottle type from the Bottle Type list.
8. Select the reagent available lot number from the Lot No. list (Optional).
On clicking, reagent details will be saved to the selected position and displayed in the
positions grid on the screen.
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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.
Starting analysis
2. To start the run (measurement), select the group no. and click on start arrow button,
provided on screen.
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7-23 Operation
In closed system, batch run will not be started, if user defined open
channels are more than the permitted limit.
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.
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.
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.
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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.
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.
On resuming batch run or when the run is completed, a beep will be sounded
by the analyzer.
EM 200
Operation 7-26
During run, the user can monitor the online reaction curve for the test. See section Reaction Curve
for more details.
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.
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.
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.
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
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7-27 Operation
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.
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.
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
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.
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.
Use Refresh Position button to reschedule the reagent bottle positions, which
are deactivated during run. See Refresh Positions for more details.
Schedules
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.
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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, 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.
3. Choose the appropriate option from the shutdown screen. See section Shutdown for more
details.
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.
Flag list
List of errors
EM 200
Error Handling 8-3
EM 200
8-4 Error Handling
EM 200
Error Handling 8-5
EM 200
8-6 Error Handling
EM 200
Error Handling 8-7
EM 200
8-8 Error Handling
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
EM 200
Error Handling 8-11
EM 200
8-12 Error Handling
Trough> Execute
commands
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
EM 200
8-16 Error Handling
EM 200
Error Handling 8-17
Cuvette rotation
EM 200
8-18 Error Handling
EM 200
Error Handling 8-19
to reagent outer>
Execute commands
EM 200
8-20 Error Handling
EM 200
Error Handling 8-21
EM 200
8-22 Error Handling
EM 200
Error Handling 8-23
EM 200
8-24 Error Handling
EM 200
Error Handling 8-25
EM 200
8-26 Error Handling
EM 200
Error Handling 8-27
EM 200
8-28 Error Handling
EM 200
Error Handling 8-29
EM 200
8-30 Error Handling
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
EM 200
Error Handling 8-33
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
EM 200
8-36 Error Handling
<Aspirate/Dispense>
commands
EM 200
Error Handling 8-37
stirrer connectors
action for 3. Opto
Reagent 2 Supply
EM 200
8-38 Error Handling
commands
EM 200
Error Handling 8-39
2. Check opto
connectors are
connected properly or
not.
EM 200
8-40 Error Handling
EM 200
Error Handling 8-41
EM 200
8-42 Error Handling
EM 200
Error Handling 8-43
EM 200
8-44 Error Handling
EM 200
Error Handling 8-45
not..
EM 200
8-46 Error Handling
3. Connector
connections
EM 200
Error Handling 8-47
EM 200
8-48 Error Handling
3. Connector
connections
EM 200
Error Handling 8-49
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.
Setting UI language
Access control
Create profile
For more information on setting the user access see section User Rights.
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.
List of Languages supported: English, Chinese, Italian, Spanish, Portuguese, Russian, French,
German, Polish and Czech.
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.
EM 200
Configuration 9-4
4. Rearrange the tests as required using the buttons provided for sorting.
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
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.
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.
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.
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.
EM 200
Configuration 9-8
3. Click EDIT.
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.
On successful connection, connection between the LIS and host will be established, and
data will be saved.
EM 200
9-9 Configuration
IP Address
Port No.
Make sure that the port number entered in the host computer should match with
analyzer's PC.
On successful connection, connection between the LIS and host will be established, and
data will be saved.
EM 200
Configuration 9-10
Name of analyst
Name of laboratory
Name of manufacturer
Types of unit
Calculation formula
Instrument
4. Click on SAVE.
5. This will add the area name and displayed in the grid.
4. Click on EDIT.
6. Click on SAVE.
EM 200
9-11 Configuration
4. Click on DELETE.
6. Click on SAVE.
4. Click on SAVE.
5. This will add the doctor name and displayed in the grid.
4. Click on EDIT.
6. Click SAVE .
7. This will update the doctor's name and displayed in the grid.
4. Click DELETE.
EM 200
Configuration 9-12
4. Click SAVE.
5. This will add the analyst name and displayed in the grid.
4. Click EDIT.
6. Click SAVE .
7. This will update the analyst's name and displayed in the grid.
4. Click DELETE.
4. Click SAVE.
5. This will add the laboratory name and displayed in the grid.
EM 200
9-13 Configuration
4. Click EDIT.
6. Click SAVE .
4. Click DELETE.
4. Click SAVE.
4. Click EDIT.
6. Click SAVE .
7. This will update the manufacturer's name and displayed in the grid.
EM 200
Configuration 9-14
4. Click DELETE.
4. Click SAVE.
5. Click SAVE .
6. This will update the reference range and displayed in the grid.
4. Click DELETE.
EM 200
9-15 Configuration
4. Click SAVE.
To edit a unit
5. Click SAVE .
To delete a unit
4. Click DELETE.
4. Click SAVE.
5. This will add the calculation formula and displayed in the grid.
To edit a formula
5. Click SAVE .
6. This will update the calculation formula and displayed in the grid.
EM 200
Configuration 9-16
To delete a formula
4. Click DELETE.
4. Click SAVE.
5. This will add the instrument name and displayed in the grid.
4. Click EDIT.
6. Click SAVE .
7. This will update the instrument's name and displayed in the grid.
4. Click DELETE.
EM 200
9-17 Configuration
Data archiving improves the performance of (Live) database with the following key benefits.
For archiving and restoring patient data, the Archive option will appear on the main menu as shown in
the following figure.
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.
Archiving Data.
EM 200
Configuration 9-18
Observations
1. Click on the Archive option from the main menu. following screen will be displayed
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
4. After completing the archive process, a message “Archived data successfully” will be
displayed on the screen.
1. Click on the Archive option from the main menu. Following screen will be displayed.
EM 200
Configuration 9-20
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:
Other main menu screens are not accessible for the user except the following screens:
EM 200
Configuration 9-22
Search
Reports
Archive
Shutdown
Add profile
Delete profile
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.
5. Once the profile is saved, the name appears in the Profiles 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.
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
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).
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,
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.
Daily Maintenance
Weekly Maintenance
Quarterly Maintenance
Annual Maintenance
Preventative Maintenance
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.
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.
Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.
EM 200
11-4 Maintenance
Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.
EM 200
Maintenance 11-5
15 Clean the barcode reader window in the piece of RGT base unit
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.
EM 200
11-6 Maintenance
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.
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
When any abnormal conditions are found in the analyzer, the operator is requested to check the
following items:
EM 200
Maintenance 11-7
Trouble in assay.
Serial number and lot number of reagent, calibrator and QC sample in use.
Measurement results.
Trouble in analyzer.
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.
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.
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
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
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.
11.6.6 Low Resultant Values from a Specific Method for all Samples
1 Expiration of the term of validity of reagent. See the statement of virtues that comes
together with the reagent kit for its stability.
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
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.
EM 200
Part
XII
12-2 ISE Measurment (Optional)
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.
EM 200
ISE Measurment (Optional) 12-3
Technical Specification
Measurement Theory
Shutdown Procedure
ISE Calibration
Maintenance Schedule
Troubleshooting
Error Message
EM 200
12-4 ISE Measurment (Optional)
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.
EM 200
ISE Measurment (Optional) 12-5
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
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.
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.
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
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
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.
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.
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.
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
If necessary, soak the reference electrode in warm water until the lumen of the electrode
has been cleared of salt build-up.
Calibrate analyzer.
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.
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.
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.
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.
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:
K+ 52-64 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:
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
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).
12.10 Troubleshooting
EM 200
12-10 ISE Measurment (Optional)
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
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
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
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.
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.
EM 200
12-12 ISE Measurment (Optional)
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:
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
Lot Number
Expiry Date
Distributor code (This information is stored in the reagent pack’s dallas chip and not
visible to user)
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.
ISE IT ISE Pack - Time Out Dallas chip 1. Check ISE module
Occurred absent connection
2. Ensure reagent
connector properly
connected on Dallas chip
EM 200
12-14 ISE Measurment (Optional)
3. Motor
problem
EM 200
ISE Measurment (Optional) 12-15
EM 200
Contact Us
We welcome your feedback about the product. You can reach us at the following.
Website: www.transasia.co.in
Email: transasia@transasia.co.in