C16000 App Trainning
C16000 App Trainning
C16000 App Trainning
Application Training
Program
Participant Guide
Overview
Table of Contents
Modules
Any product information in training materials should be used in conjunction with the latest version
of the Operations Manual, Operations Manual addendum, or Product Information Letter. If
discrepancies in information exist within training materials or any other materials, the latest version
of the Operations Manual, Operations Manual addendum, or Product Information Letter takes
precedence.
All samples (printouts, graphics, displays or screens, etc.) are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data shown in sample
printouts and screens do not reflect actual patient names or test results.
Each person assumes full responsibility and all risks arising from use of the Information. The
Information is presented "AS IS" and may include technical inaccuracies or typographical errors.
Abbott Laboratories reserves the right to make additions, deletions, or modifications to the
Information at any time without any prior notification.
All Abbott Laboratories product names and trademarks are owned by or licensed to Abbott
Laboratories, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, trade dress,
or product name may be made without the prior written authorization of Abbott Laboratories,
except to identify the product or services of Abbott Laboratories. All other trademarks, brands,
product names, and trade names are the property of their respective companies. All rights
reserved. Except as permitted above, no license or right, expressed or implied, is granted to any
person under any patent, trademark, or other proprietary right of Abbott Laboratories.
This guide was developed and produced by Global Service Training, Dallas, TX.
Preface - 2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Training Overview
Training Overview
Goals
• Locate and describe functions of the major external and internal system
components of ARCHITECT c16000 system.
• Run calibrations and controls to ensure patient order results are accurate.
Prerequisite Activities
In preparation, you must complete the pre-training modules and activities prior to
attending class. This material is mandatory. It is designed to provide a baseline
level of knowledge and will immediately begin building your understanding of the
integration process. This material will not be covered in class. It ensures all
Participants are at the same level of preparedness for classroom activities and
supports maximum hands-on instrument time during the training.
1. Pre-training Modules
AbbottLink CBT
ARCHITECT c16000 Instrument Overview
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Preface - 3
Materials
2. Pre-Work Activities
Obtain access to AbbottLink, Log-IC, and MyGSS.
NOTE: A 2-day AbbottLink Utilization Training Program and a 2-day Advanced
Troubleshooting Training Program (AbbottLink and Log-IC) are available for
participants via virtual class WebEx. AbbottLink Utilization and Advanced
Troubleshooting 2-day Training classes are available for additional learning.
This two day class is intended for advanced learners and not intended to be
taken as part of pre-work activity.
Materials
Safety Hazards
Preface - 4 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
How to Use This Guide
The ARCHITECT c16000 instrument has been designed for optimum operator
safety. However, this does not reduce the importance of safety awareness where
hazards exist. This section describes the types and locations of potential hazards
that could cause physical harm or damage to the laboratory environment or
where failure to follow instructions may result in instrument failure or generation of
erroneous patient results.
Chemical Hazards
Electrical Hazards
Hazards
Laser Light
Overview
• It is important to wear gloves, lab coats, and protective eye wear when
handling human sourced material or contaminated instrument components.
Black Text
• The black text will appear in both Facilitator Guide and Participant Guide.
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Preface - 5
How to Use This Guide
Resources
• Resources in black will appear in both the Facilitator and Participant Guides.
The resources are hyper links that, when selected, will take you to the location
of the specified document or resource.
Blue Text
• Text that appears in blue is intended for Application Specialists only. This
indicates tasks and activities they do as part of the role, but is NOT intended for
customers to perform.
• Demos will be conducted by the facilitator so all participants can see a given
process in action.
Preface - 6 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Contents
Contents
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 TOC-1
Contents
TOC-2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Contents
Appendix 18-1
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 TOC-3
Getting Started
Notes
Getting Started
Module Description
Module Topics
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 GS-1
Getting Started
Notes
Getting Started
GS-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Getting Started
• Safety Concerns
Notes
It is important to wear gloves, lab coats, and protective
eye wear when handling human sourced material or
contaminated instrument components.
If the possibility of pressurized liquid exists, or if significant
force is needed to perform operations where liquid may
be present, full-face protection is recommended.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 GS-3
Getting Started
Notes
Getting Started
GS-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Getting Started
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 GS-5
Getting Started
Notes
Getting Started
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
1. What is an ISA?
a) Interface Statistical Area
b) Information Setup Assistant
c) Instrument Service Advisory
2. What is a TSB?
a) Troubleshooting System Backup
b) Testing Systems Bulletin
c) Technical Service Bulletin
GS-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Getting Started
6. Abbottlink is:
a) a special section in MyGSS
b) A database for assay list numbers
c) A system remote diagnostic service tool
d) Where you locate package inserts
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 GS-7
Module 1: Overview of the ARCHITECT c16000 System
Module Description
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 1-1
Module 1: Overview of the ARCHITECT c16000 System
Module Topics:
Notes
PM - Processing Module
RSH - Robotic Sample Handler
SCC - System Control Center
Online Operations Manual
1-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 1: Overview of the ARCHITECT c16000 System
Notes
Module 1: Instrument Overview
PM - Processing Module
• Introduce Processing Center
The processing center is the main area of activity in the
processing module. Samples and reagents are
dispensed and mixed in a reaction carousel to perform
assay processing.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 1-3
Module 1: Overview of the ARCHITECT c16000 System
• Pump center
• Bulk solutions
• Sample/reagent syringes
1-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 1: Overview of the ARCHITECT c16000 System
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 1-5
Module 1: Overview of the ARCHITECT c16000 System
1-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 1: Overview of the ARCHITECT c16000 System
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 1-7
Module 1: Overview of the ARCHITECT c16000 System
1-8 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 1: Overview of the ARCHITECT c16000 System
Notes
Module 1: Instrument Overview
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 1-9
Module 2: System Statuses
Notes
Module 2: System
Statuses
Estimated Time: [30 minutes]
Module Description
In this module, you will learn about the various status names
and meanings for both the processing module and the RSH.
You will also discover how to change the processing module
and RSH status and what tasks can be performed in each.
Module Topics
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 2-1
Module 2: System Statuses
Notes
Module 2: System Statuses
2-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 2: System Statuses
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 2-3
Module 2: System Statuses
Notes
Module 2: System Statuses
Review
1. Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.What screen displays the processing module and
RSH status information?
a) The Snapshot Screen
b) The login screen
2-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 3: Consumables and Inventory Management
and Inventory
Management
Estimated Time: [135 minutes]
Module Description
This module covers the supplies and accessories you will use to
run the ARCHITECT c16000. You will replenish these supplies
frequently in the instrument and update the system supply
status.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 3-1
Module 3: Consumables and Inventory Management
Module Topics
Notes
• Inventory Management Consumables
Bulk solutions
Onboard solutions
ICT module
• Supply status
• Update supplies
• Reagents
Prepare Reagents
Load Reagents in the Carousel
• Reagent status
Disable reagent
3-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 3: Consumables and Inventory Management
Inventory Management
Reagents
ARCHITECT c16000 Reagents Overview
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 3-3
Module 3: Consumables and Inventory Management
3-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 3: Consumables and Inventory Management
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 3-5
Module 3: Consumables and Inventory Management
Resources
Notes
Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide
Demonstration: Calibrators
Demonstration: Controls
3-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 3: Consumables and Inventory Management
Reagent Status
Notes
• Show participants the Reagent Status and Reagent History
Screens.
•
Actions: Perform the activity at the end of the Module 3,
Consumables and Inventory.
Resources:
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide
Application Specialists
Purpose: To become proficient at using the Plan My Day
application available with Premium Services.
Action: Demonstrate using Plan My Day.
Discussion: Discuss any problems the participants
encountered performing the activity.
Resources:
ARCHITECT Systems Operation Manual, Section 5, Plan
My Day (Premium Feature)
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 3-7
Module 3: Consumables and Inventory Management
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
b) Processing
c) Scheduling Pause
a) True.
b) False
3-8 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 4: Robotic Sample Handler (RSH)
Notes
Module 4: Robotic
Sample Handler (RSH)
Estimated Time: [15 minutes]
Module Description
Module Topic
• RSH Functions
• RSH Bays
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 4-1
Module 4: Robotic Sample Handler (RSH)
4-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 4: Robotic Sample Handler (RSH)
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 4-3
Module 4: Robotic Sample Handler (RSH)
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
4-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 5: Daily Maintenance
Notes
Module 5: Daily
Maintenance
Estimated Time: [40 minutes]
Module Description
This module describes what happens during Daily
Maintenance and why it is so important to the operation of
your instrument and how to perform the procedure.
Module Topics
• Daily Maintenance
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 5-1
Module 5: Daily Maintenance
Notes
Module 5: Daily Maintenance
Daily Maintenance
Daily Maintenance Overview
5-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 5: Daily Maintenance
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 5-3
Module 5: Daily Maintenance
Notes
Module 5: Daily Maintenance
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
5-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Notes
Module 6: Calibrations
• Calibration types
Module Description
In this module, you will learn about calibrations: what they do,
different status types, how to order calibrations, reviewing
results and rerunning calibrations.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-1
Module 6: Calibrations
Module Topics
Notes
• Calibrations, Types, Statuses
• Calibration Orders
6-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Notes
Module 6: Calibrations
Calibration Overview
• Discuss Importance of Calibration and Calibration
Guidelines
No need to recalibrate assays every time they are run;
only perform when:
A new reagent lot number is used. In some case and
for some specific assays, calibration has to be done
every time a new cartridge is used even for the same
lot.
Documentation accompanying a new version of an
existing assay file states calibration is required.
A new assay file that requires a calibration is installed.
Calibration stability has expired
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-3
Module 6: Calibrations
Calibration Types
Notes
• The calibration type indicates whether a new calibration
curve is created, a master reference curve is adjusted or a
cutoff value is created for cSystem assays on a processing
module. The type is defined in the assay parameter file and
is assay-specific. The calibration types on the cSystem are:
Full calibration (default)
Adjust calibration (1-point, 2-point, blank or none)
6-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Calibration Statuses
Notes
• Review the different calibration statuses and logic for
active/inactive calibrations.
Failed
Failed curve validity checks.
The calibration did not complete successfully.
Manually failed.
Expired
No Cal
Pending QC
A calibration curve has been generated but at least
one level of control has not completed.
Overridden
Overridden Lot
In Process
Active
Inactive
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-5
Module 6: Calibrations
Resources:
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide, Module 6.
Resources:
6-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
• Resources:
Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide, Module 6.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-7
Module 6: Calibrations
Application Specialists
Purpose: To become proficient at ordering and reviewing
calibrations.
Actions:
Have learners review the Calibration status screen on
the SCC.
Provide the materials and supplies to allow learners to
run the calibration order for that assay. Instruct learners
to review the status during the calibration (Order and
Sample status) as well as the final calibration curve
(Calibration status).Perform the Order Calibrations
activity in the Abbott ARCHITECT® c16000 Chemistry
Customer Training Guide, Module 6.
Reference:
MyGSS/ARCHITECT/Assay Information - Troubleshooting
Guide Documents
Discussion:
Discuss any questions participants may have as a result
of performing the activity.
6-8 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Application Specialists
Purpose: To become proficient at performing calibration
troubleshooting.
Actions:
Perform troubleshooting on common calibration failures
as directed by instructor.
Related causes may be instrument, reagent, operator,
environment.
Reference:
MyGSS/ARCHITECT/Assay Information - Troubleshooting
Guide Documents
Discussion:
Discuss any questions participants may have as a result
of performing the activity. Reinforce the benefits of using
service tools to support troubleshooting.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-9
Module 6: Calibrations
Application Specialists
Purpose: To become proficient at archiving calibrations.
Actions: Perform the Archive Calibrations activity in the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide, Module 6.
Discussion:
Discuss any questions the participants may have
concerning the activity.
6-10 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Application Specialists
Purpose: To become proficient at using KM to search
calibration information errors.
Actions: Search KM for - "ICT calibration failure."
Discussion:
Discuss any questions the participants may have
concerning the activity.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-11
Module 6: Calibrations
Notes
Module 6: Calibrations
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
6-12 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 6: Calibrations
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 6-13
Module 7: Quality Control
Notes
Module 7: Quality
Control
Estimated Time: [30 minutes]
• Rerun a QC test
• Release QC results
Module Description
Module Topics
• Control Orders
• Release QC results
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 7-1
Module 7: Quality Control
• Discuss purpose of QC
7-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 7: Quality Control
Application Specialists
Purpose: To become proficient at running control orders
and reviewing QC results.
Actions: Perform the activity in the Abbott ARCHITECT®
c16000 Chemistry Customer Training Guide, Module 7.
Review QC flags in the ops manual.
Discussion: Discuss any questions participants may have
had performing the activity.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 7-3
Module 7: Quality Control
Application Specialists
Purpose: To practice archiving and deleting old control lots.
Actions: Perform activity 2 in Module 7 Control (QC) Orders
in the Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide.
Discussion: Discuss any questions the participants may
have concerning this activity.
Resources:
ARCHITECT System Operations Manual
Application Specialists
Purpose: To become proficient at using KM to search for
instrument related troubleshooting information.
Action: Perform a free text search for 'lithium qc out of
range
Discussion: Discuss any questions the participants may
have concerning this activity
Resources:
ARCHITECT System Operations Manual
7-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 7: Quality Control
Notes
Module 7: Control Orders (QC)
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 7-5
Module 8: Patient Sample Orders
Notes
Module 8: Patient
Sample Orders
Estimated Time: [90 minutes]
Module Description
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 8-1
Module 8: Patient Sample Orders
Module Topics:
• Sample Status
8-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 8: Patient Sample Orders
• Exceptions
Rerun Exceptions
Other Order Exceptions
• Stored Results
Review Stored Patient Results
Archive Stored Patient Results
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 8-3
Module 8: Patient Sample Orders
8-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 8: Patient Sample Orders
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 8-5
Module 8: Patient Sample Orders
Exceptions
Discuss the exception indicators and what they mean.
Review rerunning an exception order.
8-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 8: Patient Sample Orders
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 8-7
Module 8: Patient Sample Orders
8-8 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 8: Patient Sample Orders
Orders
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 8-9
Module 8: Patient Sample Orders
8-10 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 9: Basic Sample Progression
Notes
Module 9: Basic Sample
Progression
Estimated Time: [40 minutes]
Module Description
Module Topics
• Photometric Measurement
• Potentiometric Measurement
• Assay Processing
• ICT fluidics
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 9-1
Module 9: Basic Sample Progression
Photometric Measurement
Resources
ARCHITECT System Operations Manual
Potentiometric Measurement
9-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 9: Basic Sample Progression
ICT Fluidics
• The ICT Module is patented component used by Abbott for
indirect potentiometric measurement of electrolytes Na, K
and Cl. This module has a warranty of 60,000
determinations (20,000 samples). It requires no special
maintenance.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 9-3
Module 9: Basic Sample Progression
3. Waste is removed.
a) The syringe on the right side of the ICT aspiration pump
moves the sample from the ICT module to the
high-concentration waste compartment.
b) The syringe on the left side of the ICT aspiration pump
aspirates the liquid waste from the high-concentration
waste compartment.
c) The syringe on the left side of the ICT aspiration pump
moves the liquid waste to the high-concentration waste
tubing.
Principles of operation
9-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 9: Basic Sample Progression
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 9-5
Module 9: Basic Sample Progression
9-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 9: Basic Sample Progression
Progressions
Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 9-7
Module 10: QC Analysis
\
Notes
Module Description
Module Topic:
• Analyze QC Data
QC Summary and Reports
Levey-Jennings Graph
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 10-1
Module 10: QC Analysis
Notes
Module 10: QC Analysis
Analyze QC Data
Discuss the importance of QC analysis and what it tells
you.
Resources
Application Specialists
Purpose: To be proficient in using KM to search instrument
related troubleshooting information.
Action: Perform a free text search for 'Lithium QC out of
range.”
Discussion: Discuss any questions the participants may
have concerning this activity.
Resources:
ARCHITECT System Operations Manual
10-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 10: QC Analysis
Notes
Module 10: QC Analysis
Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 10-3
Module 11: Additional Maintenance
\
Notes
Module 11: Additional
Maintenance
Module Description
Module Topic:
• Maintenance Log
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 11-1
Module 11: Additional Maintenance
Resources
References:
11-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 11: Additional Maintenance
Maintenance
• Clean mixers
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 11-3
Module 11: Additional Maintenance
11-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 11: Additional Maintenance
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 11-5
Module 11: Additional Maintenance
11-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 11: Additional Maintenance
Notes
Module 11: Additional
Maintenance
Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide.
a) Clean mixers
a) True
b) False
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 11-7
Module 12: Common Errors and Troubleshooting
Notes
Errors and
Troubleshooting
Estimated Time: [150 minutes]
Module Description
Module Topics
• Troubleshooting Approach
• Error Codes
• Error Messages
• Diagnostic Procedures
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 12-1
Module 12: Common Errors and Troubleshooting
Troubleshooting Approach
FORT Troubleshooting Approach
12-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 12: Common Errors and Troubleshooting
Error Codes
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 12-3
Module 12: Common Errors and Troubleshooting
Error Messages
Diagnostic Procedures
12-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 12: Common Errors and Troubleshooting
error codes.
Actions: If time allows, show participants one or two of the
troubleshooting steps for common errors, such as:
Checking pipettor probe screws
Tighten pump and syringe connections
Clean the barcode reader
Check the water quality
Discussion: Discuss any problems the class had performing
the activity.
Resources:
Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 12-5
Module 12: Common Errors and Troubleshooting
12-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 12: Common Errors and Troubleshooting
Troubleshooting
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 12-7
Module 13: Basic Component Replacement
Component
Replacement
Estimated Time: [90 minutes]
Module Description
Module Topics
• Replace components
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 13-1
Module 13: Basic Component Replacement
13-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 13: Basic Component Replacement
Resources:
Notes
KM FAQ section, R&R Video Procedures/Select c16000
Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide, Module 13 Basic Component
Replacement.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 13-3
Module 13: Basic Component Replacement
Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide.
13-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
\
Notes
Module 14: Configuring
Options
Module Description
Module Topics
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-1
Module 14: Configuring Options
Notes
Module 14: Configuring Options
Configuration Settings
• Discuss purposes of configuration:
Defining the information the ARCHITECT system needs to
meet your site’s specific requirements.
14-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
• Sample Ordering
Notes
Configure settings for:
Batch ordering
Calibration ordering options
Control ordering options
Average tests per sample
Refer to Module 14 Configuration Options, in the
Customer Training Guide for further information.
• Reagents - Supplies
Reagent Options
Supply Options
• Password
• Modules
• Sample Handler
RSH Options:
Automatic reposition samples for retest
• Barcodes
• Serial Ports
• TCP/IP Ports
• Premium Software
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-3
Module 14: Configuring Options
• Actions:
Create a lab header on reports.
Enable/disable reagent expiration override.
Turn on and off Calibration Curve Details Report.
Change a user’s timeout to 30 minutes.
Discussion: Discuss any questions the participants may
have after performing the activity.
Resources: ARCHITECT System Operations Manual
14-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
Results
Notes
Age and gender specific ranges
Normal and extreme ranges
Edit or delete ranges
Linearity range
Interpretation
Name
Range
Requirement to view result
New Assay
Result Units
Panel Definitions
Retest Rules
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-5
Module 14: Configuring Options
Original dilution
Notes
Retest assays
Retest dilution
6. Configure a panel:
Panel name = Dr. Gray
Panel type = Patient
Assays: Na-C, K-C, Cl-C, GluC
14-6 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
• QC Multiconstituent Options:
Control name
Level name
Lot number
Expiration date
Import control data
Add/delete levels
Define data
Add/delete assay from level
QC time
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-7
Module 14: Configuring Options
ID
Control
Lot
Level
Assays
Westgard Rules
Rules
Disable/Enable
Flag type
Activity: Configure QC
Resources:
14-8 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-9
Module 14: Configuring Options
14-10 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 14: Configuring Options
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 14-11
Module 14: Configuring Options
Notes
Module 14: Configuring Options
Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide.
14-12 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 15: System Utilities
\
Notes
Module 15: System
Utilities
Estimated Time: [25 minutes]
Module Description
This module reviews some of the system tools for keeping the
ARCHITECT c16000 software up-to-date and backed up.
Module Topics
System Logs
Software Backup
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 15-1
Module 15: System Utilities
Notes
Module 15: System Utilities
System Utilities
System Backup
15-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 15: System Utilities
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 15-3
Module 15: System Utilities
Notes
Module 15: System Utilities
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
15-4 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 16: Abbott Tools and Resources
\
Notes
Module 16: Abbott Tools
and Resources
Estimated Time: [25 minutes]
Module Description
Module Topics
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 16-1
Module 16: Abbott Tools and Resources
16-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Module 16: Abbott Tools and Resources
Resources
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 16-3
Final Assessment Activities
Notes
Final Assessment
Activities
Estimated Time: [300 minutes]
Module Description
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 17-1
Final Assessment Activities
Notes
Final Assessment Activities
17-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Final Assessment Activities
Notes
Final Assessment Activities
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 17-3
Appendix
Figure 1:Primary components of the c16000 System
1. Processing Module
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-1
System Components Overview
Figure 2:c16000 Processing Center Components
Answer Key
1 Sample Hardware Components
2 Reagent Hardware Components
3 Reaction Carousel Components
Appendix-2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Figure 3:c16000 Sample Hardware Components
Answer Key
1 Sample carousel
2 Indicator lights
3 Sample bar code reader
4 Sample pipettor
5 Sample probe wash cup
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-3
Figure 4:c16000 Process Center
Identify the components by writing their names next to the corresponding letter.
Answer Key
1 Reagent Supply Center 1
2 Reagent Supply Center 2
3 Reagent pipettors R1A and R1B
and wash cups
4 Reagent pipettors R2A and R2B
and wash cups
5 Reagent bar code readers: Read
2D
Appendix-4 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
List of most common error messages
1. ERROR 3375 - Unable to process test, aspiration error occurred.
5. ERROR 5622 - Unable to process test, ICT reference solution cup not filling.
6. ERROR 5623 - Unable to process test, ICT reference solution not aspirated
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-5
General Error Code Ranges
1. General error codes (0001-0999)
Appendix-6 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Maintenance Log Screen
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-7
cSystems Comparison Table
Note: Parts and components on the ARCHITECT System can vary depending on the instrument manufacturing date and/or
replacement of components during service; always refer to the ARCHITECT Service and Support Manual, FRUD, and/or
ISA/TSB database for the most current information.
• The absorbance data reduction method uses the comparison between the
absorbance of the sample and the absorbance of water to calculate results.
Appendix-8 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
For end-point assays the data is expressed as absorbance and for rate assays
the data is expressed as the rate of absorbance change/minute.
• The Factor data reduction method uses a reagent blank and a fixed cal factor
value to calculate results. This method is applicable to assays for which the
reaction is linear and stable across all reagent lots. It is ideal for measuring
enzyme activity in a sample at a predictable and steady rate that can be
determined for the chromophore, wavelengths, and instrument in use.
• X = (A-Ablk) x Factor
• Where:
X = Activity or concentration of the sample (unknown)
A = Absorbance or absorbance change of the unknown
Ablk = Absorbance or absorbance change of the reagent blank
Factor = Calibration factor
Linear method
• The linear data reduction method uses a reagent blank and one to six
calibrators to generate a point-to-point calibration curve. The slope is
calculated for each segment of the curve between the calibrator levels.
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-9
Figure: 5. Linear calibration curve - six calibrators
Legend:
blk - Concentration of the reagent blank
C1 to C6 - Concentration of calibrator
Ablk - Absorbance or absorbance change of the reagent blank
Ac1 to Ac6 - Absorbance or absorbance change of the calibrator
The absorbance or absorbance change measured for the sample determines
which of the following equations are used to calculate the sample
concentration.
• When A Ac1
• X = F1 × (A - Ablk) + blk
Appendix-10 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
• When Ac1 < A Ac2
• X = F2 × (A - Ac1) + C1
• X = F3 × (A - Ac2) + C2
• X = F4 × (A - Ac3) + C3
• X = F5 × (A - Ac4) + C4
• X = F6 × (A - Ac5) + C5
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-11
• Where:
A = Absorbance or absorbance change of the sample (unknown)
Ac1 to Ac6 = Absorbance or absorbance change of the calibrator
Ablk = Absorbance or absorbance change of the reagent blank
X = Concentration of the sample (unknown)
C1 to C6 = Concentration of calibrator
blk = Concentration of the reagent blank
F1 to F6 = Cal factor (1 / slope)
Logit-4 method
The Logit-4 data reduction method uses a reagent blank and three to six
calibrators to generate a calibration curve. This method is applicable to
assays for which the absorbance or absorbance change increases as the
calibrator concentration increases.
Appendix-12 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Figure: 6. Logit-4 calibration curve - three to six calibrators
Legend:
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-13
Where:
A = Absorbance or absorbance change of the sample (unknown)
Kc, a, b = Constants of the approximation expression
Ablk = Approximate value of the absorbance or absorbance change of the
reagent blank
X = Concentration of sample (unknown)
ln = Natural log
Spline method
• The spline data reduction method uses a reagent blank and three to six
calibrators to generate a calibration curve. The concentration axis of the
calibration curve graph is divided into multiple sections with the divisions
corresponding to the concentrations of the calibrators. Each section of the
curve is interpolated using a polynomial expression so that the adjoining
sections are connected smoothly.
Appendix-14 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Figure: 7. Spline calibration curve - three to six calibrators
Legend:
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-15
calculate results. This method is used when two or more assays use the same
reagents. The reference assay is defined in the assay parameter file.
Legend:
Ac1' - Absorbance or absorbance change of the calibrator used for the reference
test
Ablk' - Absorbance or absorbance change of the reagent blank for the reference
test
Appendix-16 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Potentiometric data reduction method
• Slope calculation
• Sample measurement
ΔEi = Potential difference between the sample and ICT Reference Solution for
each electrode
= Potential of each electrode (i), in contact with ICT Reference
Solution
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-17
Es,i = Potential of each electrode (i), in contact with the sample
i = Ion of interest (Na+, K+, and Cl-)
EMF = Electromotive force expressed in millivolts
Slope calculation
The slope calculation uses the differences (potential differences) between the
electromotive forces of two calibrators and the electromotive force of the ICT
Reference Solution and compares them to the calibrator concentrations to
generate a calibration curve. Two graphs are generated:
Where:
S = Slope (mV/decade) of each electrode
Appendix-18 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
CL, CH = Concentration of the Low and High Calibrators
CN = Concentration of ICT Reference Solution
ΔEL, ΔEH = Difference in potential of each electrode between the ICT
Reference Solution and the calibrator
Ci = Concentration of the specific ion of interest
EMF = Electromotive force expressed in millivolts
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-19
Figure: 11. Electrode (mV) response curve during calibration
Where:
CL, CH = Concentration of the Low and High Calibrators
CN = Concentration of ICT Reference Solution
ΔEL, ΔEH = Difference in potential of each electrode between the ICT
Reference Solution and the calibrator
Ci = Concentration of the specific ion of interest
EMF = Electromotive force expressed in millivolts
Sample measurement
• The sample measurement uses the following data to determine the electrolyte
(ICT) concentration in an unknown sample:
The difference between the electromotive forces of the unknown sample
and the ICT Reference Solution
The difference between the electromotive forces of the low calibrator and
the ICT Reference Solution
The slope of the specific ICT electrode
Appendix-20 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
• The following equation is used:
Where:
Ci = Concentration of the specific ion of interest in the sample
CL = Concentration of the ion of interest in the Low Calibrator (This is the
baseline for sample calculations.)
S = Slope of the ICT electrode of interest
ΔEi = Difference in electrode potential when exposed to the sample and ICT
Reference Solution
ΔEL = Difference in the ICT electrode potential when exposed to ICT
Reference Solution and the Low Calibrator during calibration
CN = Concentration of ICT Reference Solution
EMF = Electromotive force expressed in millivolts
ICT Index
An Index solution can be used to compensate for differences between ICT
modules, day-to-day instrument variations, and matrix differences between
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-21
calibrators and patient samples. The Index solution is a sample with a known
concentration and is used during calibration of an ICT analyte. After calibration
sample measurements are then automatically adjusted.
Measured sample values are adjusted using the following equation:
Conc' = Conc - (Comp' - Comp)
Where:
Conc' = Adjusted ICT sample value
Conc = Measured ICT sample value (not adjusted)
Comp' = Measured value of Index solution
cSystem data reduction methods
Comp = Nominal Index concentration (known value)
(Comp' - Comp) = Adjustment value
The Index solution concentration for the specific analyte is calculated using the
following equation:
Comp' =
• NOTE: When the Index concentration is set to zero the Index value is not
calculated.
Appendix-22 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
ICT Fluidics Flow
Figure 13:ICT Fluidics Flow
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-23
Comparative Training Times Across Multiple
Instruments
Module Name C4000 C8000 C16000 C8000 C16000
1st Class 1st Class 1st Class 2nd Class 2nd class
Additional Additional
minutes minutes
needed needed
Getting 75 75 75
Started/Overview
Instrument 45 45 105 45 45
Overview/Basics
System Statuses 30 30 30
Consumables 105 105 135 60 60
RSH 15 15 15 15 15
Daily Maintenance 40 40 40 40 40
Calibration 120 120 125 10
Quality Control Orders 30 30 30
Patient Sample Orders 90 120 90 30 30
Basic Sample 40 40 40 40 40
Progression
QC Analysis 25 25 25
Additional Maintenance 150 165 180 15 45
Common 150 150 150
Errors/Troubleshooting
Basic Component 60 60 90 30
Replacement
Configuration 180 180 180
System Utilities 25 25 25
Abbott Tools 25 25 25
Assessment 300 300 300 300 300
Total Minutes 1505 1550 1585 545 615
Total Hours 25.08 25.83 26.42 9.08 10.25
Appendix-24 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101