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Global ARCHITECT c8000

Application Training
Program

Participant Guide

Overview

Table of Contents

Modules

Global ARCHITECT c8000 Application Training Program | Global Service Training|80000617-101


Revision History
REVISION STATUS
Document Revision Date Content or Pages Revised, Added, or
Control Deleted
Number
80000617-101 New Release

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.

Copyright 2015, Abbott Laboratories, Abbott Park, Illinois.

i-2 Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101
Training Overview

Training Overview

The ARCHITECT c8000 Application Training Program is designed to provide Global


Application Specialists with instrument knowledge and skills needed to perform
effective ARCHITECT c8000 operations and procedures.

Goals

Upon completion of the training program you will be able to:

• Locate and describe functions of the major external and internal system
components of ARCHITECT c8000 system.

• Explain the basic process of the ARCHITECT c8000.

• Operate the instrument to run patient sample orders.

• Run calibrations and controls to ensure patient order results are accurate.

• Complete maintenance activities to keep the instrument in good working


condition for accurate results.

• Use support tools that includes Active Sense Technology.

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.

Prerequisite activities that must be completed are:

1. Pre-training Modules
 AbbottLink CBT
 ARCHITECT c8000 Instrument Overview

Global ARCHITECT c8000 Application Training Program| Global Service Training| 80000617-101 i-3
Materials

 Service Tools Overview


 Basic Clinical Chemistry
 Basic QC
 FORT
 Active Sense Technologies (AST) Daily Schedule Integration
 AST Tools How-to Skills Training

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 participants and not intended
to be taken as part of pre-work activity.

Materials

The Global ARCHITECT c8000 Application Training Class will be presented by


facilitators using the following materials:
 ARCHITECT System Operations Manual
 ARCHITECT c8000 Service and Support Manual
 Abbott ARCHITECT c8000 Chemistry Customer Training Guide
NOTE: All example printouts, graphics, displays, screens, etc. are for information
and illustration purposes only. Actual printouts, graphics, displays, screens,
etc. may vary depending on software revision, hardware revision, and
instrument configuration.

Abbott System Operations Manuals, Assay-specific Package Inserts, Technical


Service Bulletins, and Instrument Service Advisories can be accessed through the
Abbott Global Service and Support Intranet site unless otherwise noted. Service
Personnel should keep their laptop or iPad updated to contain current revision
levels of materials.

Safety Hazards

i-4 Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101
How to Use This Guide

The ARCHITECT c8000 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.

Warnings are inserted throughout the ARCHITECT System Operations Manual to


alert Specialists or alert the Application Specialist to potential hazards. You should
refer to the following links for safety hazard information prior to beginning this
training course.

ARCHITECT c8000 Safety Hazard Information


Hazard Signal Words

Safety Icons and Hazard Symbols

Electrical Hazards

Laser Light

Biological Hazards

Chemical Hazards

Electrostatic Discharge

How to Use This Guide

Black Text

• The black text will appear in both Facilitator Guide and Participant 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.

Global ARCHITECT c8000 Application Training Program| Global Service Training| 80000617-101 i-5
How to Use This Guide

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.

Activity: Name of Activity

• Activities are provided throughout the guide to allow participants to practice


the concepts and techniques discussed.

Demonstrate: Concept or Process Name

• Demos will be conducted by the facilitator so all participants can see a given
process in action.

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Contents

Contents
Revision History ...................................................................................................i-2

Getting Started 1-1


ARCHITECT c8000 Application Training Overview........................................ 1-2
Use Service Tools .............................................................................................. 1-4
Review............................................................................................................... 1-6

Module 1: Overview of the ARCHITECT c8000 System 1-1


PM - Processing Module .................................................................................. 1-3
RSH - Robotic Sample Handler ....................................................................... 1-4
SCC - System Control Center ......................................................................... 1-4
Review............................................................................................................... 1-8

Module 2: System Statuses 2-1


System Statuses and their Meanings.............................................................. 2-2
Review............................................................................................................... 2-4

Module 3: Consumables and Inventory Management 3-1


Reagents........................................................................................................... 3-3
Review............................................................................................................... 3-8

Module 4: Robotic Sample Handler (RSH) 4-1


RSH Functions & Sections ................................................................................ 4-2
Review............................................................................................................... 4-4

Module 5: Daily Maintenance 5-1


Daily Maintenance .......................................................................................... 5-2
Review............................................................................................................... 5-4

Module 6: Calibrations 6-1


Calibration Overview ...................................................................................... 6-3
Calibration Types ............................................................................................. 6-3
Review............................................................................................................. 6-10

Global ARCHITECT c8000 Application Training Program| Global Service Training| 80000617-101 TOC-1
Contents

Module 7: Quality Control 7-1


Quality Control ................................................................................................. 7-2
Review............................................................................................................... 7-4

Module 8: Patient Sample Orders 8-1


Patient Sample Order Types ........................................................................... 8-3
Review............................................................................................................... 8-7

Module 9: Basic Sample Progression 9-1


Photometric and Potentiometric Measurement Methods.......................... 9-2
ICT Fluidics......................................................................................................... 9-3
Review............................................................................................................... 9-6

Module 10: QC Analysis 10-1


Analyze QC Data........................................................................................... 10-2
Review............................................................................................................. 10-3

Module 11: Additional Maintenance 11-1


Weekly and Monthly Maintenance ............................................................. 11-2
Perform Maintenance Procedures .............................................................. 11-3
Review............................................................................................................. 11-7

Module 12: Common Errors and Troubleshooting 12-1


Troubleshooting Approach........................................................................... 12-2
Review............................................................................................................. 12-5

Module 13: Basic Component Replacement 13-1


Replace System Components...................................................................... 13-2
Review............................................................................................................. 13-4

Module 14: Configuring Options 14-1


Configuration Settings ................................................................................... 14-2
Review........................................................................................................... 14-12

Module 15: System Utilities 15-1


System Utilities ................................................................................................. 15-2

TOC-2 Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101
Contents

Review............................................................................................................. 15-4

Module 16: Abbott Tools and Resources 16-1


Abbott Tools and Resources......................................................................... 16-2
Review............................................................................................................. 16-3

Final Assessment Activities 17-1


Complete Troubleshooting Practical Activities .......................................... 17-2
Complete the Final Written Assessment ...................................................... 17-3

Appendix 18-1

Global ARCHITECT c8000 Application Training Program| Global Service Training| 80000617-101 TOC-3
Getting Started

Notes

Getting Started

Estimated Time: [75 minutes]

Objectives: • Discuss the Overview of ARCHITECT c8000


Global Application Training Program

• Demonstrate proficiency in using MyGSS


service tools

Module Description

This module provides an overview of ARCHITECT c8000


Application Training Program, expected training outcomes,
and use of service tools.

Module Topics

• ARCHITECT c8000 Application Training Program overview

• Use of service tools

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 GS - 1
Getting Started

Notes
Getting Started

ARCHITECT c8000 Application Training


Overview
Discuss Overview of ARCHITECT c8000 Global Application
Training Program

• Review class agenda

• Define class expectations


 Confirm completion of pre-training requirements by all
participants; set completion expectation for individuals
who have not finished required pre-learning
 Log-IC is a diagnostic tool used to evaluate logs. Further
detailed training is available.

GS - 2 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
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 c8000 Application Training Program | Global Service Training| 80000617-101 GS - 3
Getting Started

Notes
Getting Started

Use Service Tools


Activity: Knowledge Management Activity

Purpose: To demonstrate the use of Knowledge


Management searches to find troubleshooting information.
Actions: Use the general search function to perform the
following tasks:
 Search for Error Code 0218 in Knowledge Management
(KM).
 Are you able to filter the results for the c8000 instrument?
 What is the first resolution recommended?
 Search for an observed error and type the following in
the search box “GGT QC Out of Range” and write the
search results from KM below.
 What general information is provided if you choose
Technopath controls?
Discussions: Check understanding of KM tool and key
features.

GS - 4 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Getting Started

Activity: AbbottLink Activity Notes

Purpose: To perform support related AbbottLink tasks.


Action: Log in to AbbottLink using your ID and password.
 Create a watch list using serial number c800086.
 Access message history and historical data for an
ARCHITECT c8000.
 Retrieve the Troubleshooting Pack 1 for the ARCHITECT
c8000.
 Save the results to a log folder.
Discussion: Briefly identify the benefits of the watch list and
the use of log files.

Activity: Locating and Navigating in MyGSS

Purpose: To become proficient at locating information in


MyGSS.
Actions: Locate the training checklist in MyGSS.
Discussion: Discuss any questions regarding locating the
training checklist in MyGSS.
Resources:
 MyGSS/Product Family/ARCHITECT/Architect - Global
Service & Support/Training Tools/Checklists

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 GS - 5
Getting Started

Notes
Getting Started

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 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

3. Where do you find the Knowledge Management System


(KM)?
a) On MyGSS, under Product Families
b) From the Tools and Links section of MyGSS
c) In the eSolutions Troubleshooting Database

GS - 6 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Getting Started

4. Where do you find ARCHITECT Assay information?


Notes
a) MyGSS/Product Families/ARCHITECT/Assay Information
b) In the ISA/TSB Database
c) Under Knowledge Management

5. The Knowledge Management System is:


a) Centralized repository for all troubleshooting and repair
procedures
b) A tool for identifying assay inserts
c) The place where service manuals are located.

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 c8000 Application Training Program | Global Service Training| 80000617-101 GS - 7
Module 1: Overview of the ARCHITECT c8000 System

Module 1: Overview of Notes

the ARCHITECT c8000


System
Estimated Time: [45 minutes]

Objectives: • Explain the basic process of the ARCHITECT


c8000

• Identify major external and internal system


components

• Log onto the ARCHITECT software

• View the Snapshot screen

• Access and navigate the online


Operations Manual

Module Description

• In this module, you will learn about the main components of


the instrument and the basic functions of the system
software.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 1-1
Module 1: Overview of the ARCHITECT c8000 System

Module Topics:
Notes
 PM - Processing Module
 RSH - Robotic Sample Handler
 SCC - System Control Center
 Online Operations Manual

1-2 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 1: Overview of the ARCHITECT c8000 System

Notes
Module 1: Instrument Overview

Activity: Identifying Components

Application Specialists
Purpose: To become proficient at identifying components.
Actions: Use the instrument graphic in the Appendix,
Instrument Component Overview, to write in the
component name in the box as the instructor identifies
them during the overview.
Discussions: Discuss any questions or issues that may arise
from the activity.

PM - Processing Module
• Introduce Processing Center

• The main activity area of PM where samples and reagents


are dispensed and mixed into cuvettes where assay
processing is performed.

• Refer to processing center graphic in the Appendix of this


manual as you discuss components:
 Sample hardware components
 Sample pipettor
 Sample probe wash cup
 Sample wash solution
 Sample carousel

1-4 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 1: Overview of the ARCHITECT c8000 System

 Reagent hardware components


Notes
 Reagent supply centers
 Reagent pipettor 1 and wash cup
 Reagent pipettor 2 and wash cup
 Reagent bar code readers
 Reagent supply center advance button
 Reaction carousel hardware components
 Cuvette segments
 Lamp
 Mixer unit
 Cuvette washer
 ICT unit
 Water bath/waste overflow area
 ICT waste area
 High concentration waste pump

Supply and Pump Center

• Pump center

• Bulk solutions

• Sample/reagent syringes

RSH - Robotic Sample Handler


• Discuss RSH. Refer to the ARCHITECT Systems Operations
Manual Section 1-8

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 1-5
Module 1: Overview of the ARCHITECT c8000 System

Notes SCC - System Control Center


• Discuss SCC. Refer to the ARCHITECT Systems Operations
Manual Section 1-11.

• SCC - Controls the PM and RSH; provides user interface for


orders, QC, configuration, etc., via touchscreen monitor.
 CPU
 External Multi-port Serial Adapter (EMSA) - optional
 HUB
 Monitor
 Sample Barcode Reader
 Articulated ARM

• From the SCC you can:


 Configure the system.
 Enter patient, control and calibration orders, and review
results.
 Control the processing module(s) and the sample
handler.
 Perform system diagnostics and maintenance
procedures.
 Receive test orders and diagnostic data from a host
computer.
 Transfer test results to a host computer.

• Basic navigation of SCC Snapshot screen.

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Module 1: Overview of the ARCHITECT c8000 System

• Review items below:


Notes
 Icons - Represent a category of screens.
 When you select an icon, a menu displays below the
icon.
 Related windows provide additional details or
functions related to the active screen.
 Menus - List the available items for the selected
category.
 When you select a menu item, the associated screen
displays.
 Messages or prompts -Provide informational or error
messages that allow you to complete a procedure or
address the current situation.
 Screens - Provide access to all related system
information and functions.
 Help button - Provides access to context-sensitive help
for the active screen, window, or error message.
 Buttons - Allow you to perform actions associated with
the active screen and correspond to the function keys
on the keyboard. Some may be unavailable until you
make a selection on the screen.

• Logging into the SCC


 CSC Login
 FSE Login
 General
 System Administrator - Access Levels. User ID=ADMIN,
password=ADM
 Premium feature – System Administrator can create
user specific log on.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 1-7
Module 1: Overview of the ARCHITECT c8000 System

Online Operations Manual


Notes
• Online Operations Manual
 Briefly describe sections of the ARCHITECT System
Operations manual, when and how to use them:
 Section 4 Specifications
 Section 9 Service and Maintenance
 Section 10 Troubleshooting and Diagnostics
 Demonstrate ways to access the online ARCHITECT
System Operations manual.
 Demonstrate how to print a page/topic and how save a
favorite.

Activity: Accessing the Online Operations Manual

Purpose: To practice using the operations manual.


Actions:
 Direct participants to explore Index, Content, and
Search (Wildcard option)
 Ask participants to search a topic (e.g. sample
probes) for instructions.
 Ask participants to search information for an error
code for troubleshooting.
 Ask participants to save one search as a favorite
then delete it.
 Locate the area where accessories and consumable
list numbers are located.
Discussions: Discuss and questions or issues that arise from
performing the activity.

1-8 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 1: Overview of the ARCHITECT c8000 System

Activity: Navigate the SCC Notes

Purpose: To practice logging on and off and printing.


Actions: Perform the logging on and off activity in the
customer training guide.
 Refer to Activity: Module 1 from the Abbott
ARCHITECT c8000 Chemistry Customer Training
Guide.
Discussion: Discuss questions or issues that arise from
performing the activity.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 1-9
Module 1: Overview of the ARCHITECT c8000 System

Notes
Module 1: Instrument Overview

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. Which are the two types of bays in the RSH?


a) Priority and Routine
b) Primary and Secondary
c) Priority and Urgent
d) Green and Amber

2. Why is it necessary to ensure the system is returned to a


non-Abbott log on upon completion of your support
activities?
a) To avoid untrained individuals having access to
otherwise unavailable areas.
b) To prevent the system from automatically rebooting.

3. In addition to general user and administrator log on, Abbott


representatives can log on as:
a) CSC
b) FSE
c) Both a and b

1-10 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 2: System Statuses

Notes
Module 2: System
Statuses
Estimated Time: [30 minutes]

Objectives: • Explain the various statuses of the


processing module and RSH

• Change the status of the processing


module and RSH

• Explain when you would need to turn the


system off and on

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

• Processing Module status types

• RSH status types

• Changing system status

• Turning system off and on

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 2-1
Module 2: System Statuses

Notes
Module 2: System Statuses

System Statuses and their Meanings


• Discuss the meaning of each of the nine status types and
what is happening when that system status displays. Refer
to the table in the Abbott ARCHITECT c8000 Chemistry
Customer Training Guide.
 Off-line
 Stopped
 Warming
 Ready
 Running
 Scheduled Pause
 Initializing
 Scanning
 Maintenance

• Review System status sequence graphic in the Abbott


ARCHITECT c8000 Chemistry Customer Training Guide.

• Review how to change statuses.

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Module 2: System Statuses

Demonstration: Turning the System On and Off


Notes
• Review the steps for turning the system on and off.

• Have participants walk through each step of the process as


outlined in the Abbott ARCHITECT c8000 Chemistry
Customer Training Guide.
Purpose: To become proficient at changing system

Activity: Change System Statuses

statuses.
Actions:
 Complete the activity at the end of Module 2 in the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.
Discussion: Highlight key steps used in changing system
status.
Resources
 ARCHITECT System Operations Manual, 1-225

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 2-3
Module 2: System Statuses

Notes
Module 2: System Statuses

Review
1. Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.What screen displays the processing module and
RSH status information?
a) The Snapshot Screen
b) The login screen

2. What status must the ARCHITECT cSystem be in to perform


Daily Maintenance?
a) Running
b) Ready
c) Maintenance
d) Stopped

3. What do you have to do to get from the Offline Status to


the Stopped Status?
a) Power on the module then choose Start-up from the
Function Menu
b) Power on the module then choose stopped from the
Function Menu
c) Power on the module and wait
d) Nothing

2-4 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 3: Consumables and Inventory Management

Module 3: Consumables Notes

and Inventory
Management
Estimated Time: [105 minutes]

Objectives: • Explain use and replacement of bulk


solutions, onboard solutions, sample wash
solutions and water bath additive

• Explain how to replace the ICT module

• Prepare 0.5% Acid Wash and 10%


Detergent B solutions

• View reagent status and history

• Replace and update supplies and


reagents

• Prepare reagents and load/unload them


on the carousel

Module Description

This module covers the supplies and accessories you will use to
run the ARCHITECT c8000. You will replenish these supplies
frequently in the instrument and update the system supply
status.

Module Topics

• Inventory Management Consumables


 Bulk solutions
 Onboard solutions
 Sample wash solutions
 Water bath additive
 Replacing cartridge solutions

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 3-1
Module 3: Consumables and Inventory Management

 ICT module
Notes
• Supply status

• Update supplies

• Other consumables and accessories


 Sample cups/tubes and carriers

• Reagents
 Reagent cartridges and adapters

• Reagent status
 Disable reagent
 Onboard stability time
 Preparing reagents
 Loading reagents in the carousel
 Loading and unloading non-barcoded reagents

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Module 3: Consumables and Inventory Management

Module 3: Consumables and Notes

Inventory Management

Reagents
ARCHITECT c8000 Reagents Overview

• Reagent kits consist of one or two cartridges that contain all


the necessary reagent components for an ARCHITECT
cSystem assay.

• Review the package insert for reagent preparation and


handling.

Impact of Inventory Management on Accurate Test Results


and Workflow Efficiency

• Explain the impact of inventory management on accurate


test results and workflow efficiency.
 Efficiency is critical since adding all needed
supplies/reagents at the beginning of a shift means
continual test processing for the remainder of the shift.
 Some supplies are required to perform Daily
Maintenance procedures, so it is important to
check/update supplies before performing
maintenance.

Demonstration: Bulk Solutions

• Show participants the bottles of bulk solutions, including ICT


reference solution, alkaline wash and acid wash.

• Show participants the bottle labels and how to distinguish


between each, as the alkaline and acid wash bottles look
similar. Point out expiration dates.

Demonstration: Onboard Solutions

• Show participants the onboard solutions used on the


instrument, including a 0.5% dilution of acid wash (from bulk
solutions), Detergent A and a 10% dilution of Detergent B.
Point out expiration dates on bottles.

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Module 3: Consumables and Inventory Management

• Demonstrate preparing the acid wash dilution or Detergent


Notes
B dilution using purified water with the help of one or two
participants.

• Optional: If there is not enough time or materials available,


participants can watch any applicable videos in the online
Operations Manual.

Demonstration: Sample Wash Solutions

• Show participants the sample wash cups and the solutions


used, including the 0.5% acid wash dilution and Detergent
A used as onboard solutions, as well as ICT cleaning fluid.

• Demonstrate preparing the ICT cleaning fluid in the


lyophilized solution bottle. Then demonstrate replacing the
solutions in the sample wash cups. Emphasize replacing the
entire sample cups each day when replacing the solutions.

• Optional: If time and materials are not available, you can


have participants view any applicable videos in the online
Operations Manual.

Demonstration: Water Bath Additive

• Show participants the water bath additive bottle, its


expiration date label, and how to distinguish it between
other similar-looking bottles.

Demonstration: Replacing Cartridges in Reagent Carousels

• Show participants replacement cartridges used for various


solutions and where they typically are placed in the
reagent carousel.

• Demonstrate the location of the reagent bar code readers


in reagent supply center 1 and reagent supply center 2.

• Show the participants the various types of reagent


adapters.

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Module 3: Consumables and Inventory Management

Demonstration: ICT Module


Notes
• Show participants where in the supply Status Screen to
update the ICT module information. Discuss the warranty of
the module.

• Show participants where in the supply Status Screen to


update the ICT module information.

Demonstration: Updating Supplies

• Show participants how to update supplies and inventory


levels on the Update supplies screen on the SCC.

Demonstration: Adjust Level

• Show participants adjust level function.

Demonstration: Samples Cups and Carriers

• Show participants sample carriers, Abbott sample cups and


any available tubes. Point out the graduated lines on
sample cups – participants will need to use these later
when measuring sample volumes.

• Demonstrate how the cups/tubes are put into sample


carriers.

Resources
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 3-5
Module 3: Consumables and Inventory Management

Notes Activity: Using Plan My Day

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)

Activity: Updating the Supply Status Screen

Application Specialists
Purpose: To become proficient at determining supply
statuses and updating the Supply Status screen.
Action: Allow participants to practice checking the status
of supplies, bulk and onboard solutions, and reagents on
the SCC, then replenishing any needed supplies and
solutions on the instrument.
Discussion: Discuss any problems the participants
encountered performing the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 3 Consumables and Inventory
Management.

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Module 3: Consumables and Inventory Management

Activity: Load Reagents Notes

Purpose: To become proficient at replacing reagents.


Action: Perform Activity 2: Load Reagents, Customer
Training Guide, at the end of Module 3.
Discussion: Discuss any problems the participants
encountered performing the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 3 Consumables and Inventory
Management.

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Module 3: Consumables and Inventory Management

Notes Module 3: Consumables and


Inventory Management

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. What time of the day, or during which shift is it practical to


perform inventory management?

2. Where do you find reagent handling and storage


requirements?

3. Where is the ARCHITECT c8000 reagents MSDS sheets


information located?

4. In order to load reagents on Architect cSystem, the


instrument status must be:
a) Stopped or ready.
b) Processing
c) Scheduling Pause
.

5. If you are not loading samples/calibrators/controls in the


sample carousel in c8000 or c16000 then you don’t need
to replace on board solutions and update inventory in
carousel position 31 and 32.
a) True.
b) False
c) True only in special conditions.

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Module 4: Robotic Sample Handler (RSH)

Notes
Module 4: Robotic
Sample Handler (RSH)
Estimated Time: [15 minutes]

Objectives: • Identify RSH routine and priority bays

• Explain RSH indicator lights

• Perform as-needed maintenance


procedures for RSH

Module Description

This module covers sample carriers, how to load and unload


these carriers on the RSH, and as-needed maintenance
procedures.

Module Topic

• RSH Functions

• RSH Bays

• RSH Indicator Lights

• Opening RSH Covers

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Module 4: Robotic Sample Handler (RSH)

Notes Module 4: Robotic Sample


Handler (RSH)

RSH Functions & Sections


Demonstration: RSH & Loading the Carrier
 Review status indicator lights.
 Lights Off: No Samples Loaded.
 Green Steady: Sample Loaded but not yet
processing. Can access.
 Amber Steady: Processing. Cannot access.
 Green Blinking: Ready to unload. Able to access.
 Green/Amber Blinking: Error state. Able to access.
Check for errors.
Resources:
 ARCHITECT System Operations Manual, Section 1-209
 Abbott ARCHITECT c8000 Chemistry Customer Training
Guide, Module 4 Robotic Sample Handler

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Module 4: Robotic Sample Handler (RSH)

Activity: Load Carriers into the RSH Notes

Purpose: To practice loading sample carriers and trays in


the RSH.
Actions:
 Complete the activity in Abbott ARCHITECT c8000
Chemistry Customer Training Guide, Module 4 RSH, near
the end of the module.
Discussion: Discuss the elements of the RSH and how it
moves and processes the sample carriers and trays.

Activity: RSH Bar Code Calibration

Purpose: To become proficient at calibrating RSH bar code


reader.
Actions:
 Perform RSH bar code calibration.
 Procedures 1119 Transport Calibration.
Discussion: Discuss other as-needed maintenance
procedures.

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Module 4: Robotic Sample Handler (RSH)

Notes Module 4: Robotic Sample


Handler (RSH)

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. Discuss the RSH carrier status lights.

2. Where are the steps for performing a RSH bar code


calibration located?

3. When is it safe to open an RSH cover?

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Module 5: Daily Maintenance

Notes
Module 5: Daily
Maintenance
Estimated Time: [40 minutes]

Objectives: • View Maintenance procedures

• Perform Daily Maintenance procedure

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 Topic

• Daily Maintenance

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Module 5: Daily Maintenance

Notes
Module 5: Daily Maintenance

Daily Maintenance
Daily Maintenance Overview

• Explain the importance of daily maintenance.


 Discuss and demonstrate the Daily Maintenance
procedure
 Frequency – every day (24 hrs) the system is in operation
 Time to complete and what the system does during
procedure.

Activity: Perform Daily Maintenance Procedures

Purpose: To become proficient at performing maintenance


procedures.
 Perform Daily Maintenance procedure for the
ARCHITECT c8000 Module.
Resources
 ARCHITECT System Operations Manual

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Module 5: Daily Maintenance

Notes
Module 5: Daily Maintenance

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. What are the solutions required to perform daily


maintenance?

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Module 6: Calibrations

Notes

Module 6: Calibrations

Estimated Time: [2 Hours]

Objectives: • Explain the need for calibrations

• Calibration types

• Describe calibration statuses

• Run a calibration order

• View calibration status and history

• Identify problem causes and troubleshoot


common calibration failures

• Use KM tools to support basic calibration


troubleshooting

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.

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Module 6: Calibrations

Module Topics
Notes
• Reasons for Calibration

• Calibration Types

• Viewing Calibration Status Screens

• Viewing Calibration Status and Histories

• Calibration Failures & Troubleshooting

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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 them when:
 A new reagent lot number is used. In some cases 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.

Calibration Types
• 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)

• It is important to review Calibration Types in section 6 of the


System Operations manual.

Six Methods of Calibration


There are six different mathematical methods used to
calculate results.

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Module 6: Calibrations

 Absorbance method (photometric - cSystem)


Notes
 Factor method (photometric - cSystem)
 Linear method (photometric - cSystem)
 LogIT-4 method (photometric - cSystem)
 Spline method (photometric - cSystem)
 Use factor and blank method (photometric - cSystem)

Calibration Data Reduction Method

• Review the cSystems Data Reduction Method section of


the Appendix to familiarize the participants with the 6
different methods of data reduction used on cSystems.

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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

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Module 6: Calibrations

Demonstration: Calibration Status Screen


Notes
• Refer to the Calibration Status Screen information in
Module 6 of the Abbott ARCHITECT® c8000 Chemistry
Customer Training Guide.
Resources:
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 6.

Demonstration: Calibration Preparation

• Demonstrate mixing and handling some sample calibrator


bottles so that participants become familiar with the
process of preparing calibrators in sample cups for
ordering.

• Review required calibrator volumes.


Resources:
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 6.

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Module 6: Calibrations

Demonstration: Calibration Failures and Troubleshooting


Notes
• Discuss what happens if a scan is not performed after
moving or adding reagents.

• Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 6.

Activity: Order Calibrations

Application Specialists
Purpose: To become proficient at ordering and reviewing
calibrations.
Actions:
 Have participants review the Calibration Status Screen
on the SCC.
 Provide the materials and supplies to allow participants
to run the calibration order for that assay. Instruct
participants 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® c8000 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.

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Module 6: Calibrations

Notes Activity: Order Calibrations

Application Specialists
Purpose: To become proficient at ordering calibrations.
Actions:
 Perform the Order Calibrations activity at the end of
Module 6 in the Abbott ARCHITECT® c8000 Chemistry
Customer Training Guide.
Discussion:
 Discuss any questions participants may have as a result
of performing the activity.

Activity: Troubleshooting Calibration

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.

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Module 6: Calibrations

Demonstration: Calibration Results


Notes
Show participants the Calibration results screens and review
any failed calibration curves and error codes.Resources:

• Abbott ARCHITECT® c8000 Chemistry Customer Training


Guide, Module 6.

Demonstration: Calibration History and Reports

• Show participants the Calibration History Screen and the


Cal Curve Summary Report while reviewing the information
these sources display. Discuss how to interpret this
information.

Resources:

• Abbott ARCHITECT® c8000 Chemistry Customer Training


Guide, Module 6.

Activity: Archive Calibrations

Application Specialists
Purpose: To become proficient at archiving calibrations.
Actions: Perform the Archive Calibrations activity in the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 6.
Discussion:
 Discuss any questions the participants may have
concerning the activity.

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Module 6: Calibrations

Notes Activity: KM - Search Calibration Information

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.

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Module 6: Calibrations

Notes
Module 6: Calibrations

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. List the six types of chemistry calibrations.

2. You will need to perform a calibration when a new reagent


lot is used.
a) True
b) False

3. How often do chemistry calibrations expire?


a) Every 30 days
b) They never expire
c) Assay dependent
d) 14 days

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Module 6: Calibrations

4. Can you rerun a Calibration Exception?


Notes
a) Yes
b) No

5. According to calibration logic, if there are two different lot


numbers for the same assay, and one is active and the
other has no cal, or a failed curve, which does the system
calibrate?
a) The system calibrates both.
b) The system calibrates only the no cal or failed lot
number.
c) None
d) The first position

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Module 7: Quality Control

Notes
Module 7: Quality
Control
Estimated Time: [30 minutes]

Objectives: • Run a control order for a single analyte


and a multiconstituent of various levels

• View QC results and flags

• Add a comment to a current QC result

• Rerun a QC test

• Release QC results

• View and archive stored QC results

• Troubleshoot instrument problem by using


service tools

Module Description

This module describes purpose and types of controls, ordering


a QC test, checking the status, and viewing results. In addition,
you will learn about troubleshooting of QC related instrument
problems by using service tools.

Module Topics

• Control Orders

• Review QC and flags

• Release QC results

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Module 7: Quality Control

Notes Quality Control


Quality Control Overview

• Discuss purpose of QC

Single Analyte and Multiconstituent Controls

• Identify two types of controls: single analyte (SAC) and


multiconstituent (MCC). Discuss differences, including that
most controls are multiconstituent.

• Controls may be Abbott or non-Abbott. Each control type


uses:
 Bottles labeled for each type of control material.
 The Control Order screen and has separate radio
buttons for each control type.

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Module 7: Quality Control

Demonstration: Control Order Screen


Notes

• Show participants the different views of the Control order


screen while presenting the information on single analyte
and multiconstituent controls.

• Review the Order Status and Sample Status screens for


control order status information.

Reference

• ARCHITECT System Operations Manual, Section 5

Activity: Control Orders and Flags

Application Specialists

Purpose: To become proficient at running control orders


and reviewing QC results.

Actions: Perform the activity in the Abbott ARCHITECT®


c8000 Chemistry Customer Training Guide, Module 7.

Discussion: Discuss any questions participants may have


had performing the activity.

Activity - Archive and Delete Old Control Lots

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® c8000 Chemistry Customer
Training Guide.

Discussion: Discuss any questions the participants may


have concerning this activity.

Resources:

 ARCHITECT System Operations Manual

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Module 7: Quality Control

Notes
Module 7: Control Orders (QC)

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. There are two types of controls: Single Analyte (SAC) and


_________

2. What are the consequences of deleting a QC file with a


CNTL flag on the last result generated?

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Module 8: Patient Sample Orders

Notes
Module 8: Patient
Sample Orders
Estimated Time: [120 minutes]

Objectives: • Run a patient order for single/batch


orders, bar coded or non-bar coded

• Add dilution/replicates to an order

• Add and delete a test on a patient order

• View patient order and sample status


details

• Add a comment to a patient order

• Suspend a sample in process

• Review and release patient results and


rerun exceptions

• Explain result flags

• Add a comment to a patient result

• Rerun a patient test

• View stored patient results

• Archive patient results

Module Description

This module addresses the most commonly used function on


the ARCHITECT c8000: running patient sample orders. An LIS
automates this process, however, you should know how to

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Module 8: Patient Sample Orders

manually prepare and run patient samples, change various


Notes options, rerun them (if necessary), and review results for
situations in which the LIS is unavailable.

Module Topics:

• Patient Sample Order Types

• Processing a Patient Sample Order


 Enter Carrier/SID Information
 Add Dilution/Replicates
 Enter Patient Information
 Prepare Samples
 Load Samples
 Add or Delete Test on Patient Order

• Order and Sample Status


 Order Status
 Order Schedule
 Processing Codes
 Sample Status

• Other Order Functions


 Suspend an Order in Progress
 Disable Reagent

• Patient Results and Reruns

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Module 8: Patient Sample Orders

Module 8: Patient Sample Notes

Orders

Patient Sample Order Types


Patient Sample Order Types

• Discuss patient sample order types (single, batch, bar


coded or non-barcoded batch, routine versus priority.)

Demonstration: Patient Order Screen

• Show participants the Patient Order Screen while discussing


the patient order process, including SID information,
dilutions, replicates, and sample preparation.

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Module 8: Patient Sample Orders

Notes Activity: Run Patient Sample Orders

Purpose: To become proficient at ordering and running


multiconstituent controls on single analytes, and ordering
patient samples.
Actions: Perform the activity in Module 8 in the Abbott
ARCHITECT® c8000 Chemistry Customer Training Guide.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

Activity: Batch Patient Run

Purpose: To become proficient at running patient samples


in a batch.
Actions: Have participants run a batch Chem6 panel,
following the instructions in the Abbott ARCHITECT® c8000
Chemistry Customer Training Guide, Module 8.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

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Module 8: Patient Sample Orders

Demonstration: Order Status and Sample Status


Notes
• Show participants the Order Status Screen and Sample
Status Screen on the SCC. Point out what information
displays on each that is similar or different. Reference the
processing codes when reviewing order status.

• Refer to the Sample Status page in Module 8 in the Abbott


ARCHITECT® c8000 Chemistry Customer Training Guide.

Results and Reruns


 Discuss other order functions like suspending an order.
 Discuss releasing results and the impact of doing so.
 Review result flags and their meanings.
 Review rerunning a test, when you might need or want
to rerun, and rerun result indicators.

Exceptions
 Discuss the exception indicators and what they mean.
 Review rerunning an exception order.

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Module 8: Patient Sample Orders

Notes Activity: Resolve Patient Sample Order with Exceptions

Purpose: To gain practice working with exceptions on


sample orders.
Actions: Run a patient sample order that purposely has
something wrong so that it will not complete and show as
an exception. Review the Exception Status Screen.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

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Module 8: Patient Sample Orders

Activity (Optional): Run Multiple Patient Sample Orders Notes

Purpose: To become proficient at running multiple patient


sample orders.
Actions: Depending on your class setup and availability of
time and supplies, allow participants to run at least one or
multiple patient sample orders of various types (including
batch.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

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Module 8: Patient Sample Orders

Notes Module 8: Patient Sample


Orders

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. Samples resulting in an error instead of a result can be rerun


from which screen after you resolve the error condition?

2. The ARCHITECT software provides a smart scheduler to


minimize assay-to-assay interferences when specific
combinations of assays are tested. Because of this feature,
tests _______ be aspirated in the order in which they were
added.
a) May
b) May not

3. Automated orders are available on the ARCHITECT by:


a) Host computer download
b) Host order query
c) Auto retest (Patient samples)
d) All of the above

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Module 8: Patient Sample Orders

4. What status allows you to delete an order?


Notes
a) Pending
b) Scheduled
c) Running

5. Patient results are viewed by selecting:


a) Order - Order status
b) Results - Results Review / Stored
Results/Overview-Sample Status
c) QC-Cal - QC Result Review
d) Overview - Snapshot

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Module 9: Basic Sample Progression

Notes
Module 9: Basic Sample
Progression
Estimated Time: [40 minutes]

Objectives: • Describe the basics of the Photometric


Measurement and Potentiometric
Measurement

• Explain the overall sample progression


through the process path

• Explain the ICT fluidics pathway

Module Description

This module briefly explains how the c8000 uses photometric


and potentiometric measurements, as well as the basic
progression of a sample through the instrument.

Module Topics

• Photometric Measurement

• Potentiometric Measurement

• Assay Processing

• ICT fluidics

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Module 9: Basic Sample Progression

Notes Module 9: Basic Sample


Progressions

Photometric and Potentiometric


Measurement Methods

Photometric Measurement

• Photometric technology measures the amount of light a


sample absorbs. Using Beer’s Law, the system determines
the mathematical relationship between the absorbance of
the solution and the concentration of the analyte.
Photometric measurements are for end-point and rate
assay reactions.

• This method measures:

 End-point assay reactions

 Rate assay reactions

Resources

ARCHITECT System Operations Manual

Potentiometric Measurement

• Potentiometry is a detection technology used by the


cSystem to measure electrical potential in a sample. The
cSystem uses an ICT (integrated chip technology) module
to measure potentiometric assays (electrolytes).

• Potentiometric technology measures the electrical


potential in a sample. The c8000 uses the ICT module to
simultaneously measure sodium, potassium and chloride.
The ICT obtains millivolt readings, then converts them to
assay-specific analyte conversion units. Measurements of
ICT reference solution and ICT samples are used to
calculate the assay results.

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Module 9: Basic Sample Progression

Assay Processing - Sample Progression


Notes
• Many activities take place around the reaction carousel
between the sample aspiration and final read. Each
reaction activity occurs at a specific time and location.
During processing, the reaction carousel rotates
counter-clockwise approximately 1/4 turn (approximately
41 cuvettes) every 4.5 seconds to position the cuvettes.

• There are assay processing protocols for one reagent, two


reagents, dilution, pretreatment and ICT.

• Below are some of the basic steps in the sample


progression for all assay protocol types on the c8000.

 The sample pipettor dispenses sample into the cuvette.

 Reagent pipettor 1 dispenses reagent in the cuvette.

 The mixer unit mixes the sample and reagent.

 The photometer measures the absorbance.

 The reaction mixture incubates while the photometer


takes absorbance readings.

 The cuvette washer removes the reaction mixture to


waste then cleans, aspirates and dries the cuvette.

• If a second reagent is required for the reaction, reagent


pipettor 2 dispenses the second reagent, then the mixer
unit mixes the second reagent with the sample and
reagent mixture.

• For an ICT sample, the ICT probe aspirates the diluted


sample into the ICT unit.

ICT Fluidics

• The ICT Module is a 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.

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Module 9: Basic Sample Progression

ICT reference solution and sample delivery/processing


Notes
• ICT Reference Solution and ICT samples are delivered to
the ICT module where measurement takes place.

• During processing, the following events occur:

1. The ICT reference solution cup is filled with ICT Reference


Solution. The syringe on the right side of the ICT reference
solution pump moves ICT Reference Solution from the
bottle, through the warming ring, and into the ICT reference
solution cup.

2. The ICT Reference Solution is analyzed.


a) The ICT unit moves down to position the ICT probe in the
ICT reference solution cup.
b) The syringe on the right side of the ICT aspiration pump
aspirates ICT Reference Solution from the cup into the
ICT module.
c) The ICT module measures the ICT Reference Solution
and the system converts the measurements into millivolt
readings used for reference when calculating sample
result concentrations.

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

• Refer to Section 3 in the ARCHITECT Systems Operations


Manual.

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Module 9: Basic Sample Progression

Demonstration: Sample Progression


Notes

• Discuss ICT reference solution and sample delivery


processing.

• Remind participants that they saw an animated visual of


the process in the c8000 Instrument Overview elearning
course.

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Module 9: Basic Sample Progression

Notes Activity: Assay Processing for Different Reagent Protocols

Purpose: To understand the timing of the assay protocols


Actions: Search the online ops manual for assay processing
for "reagent protocol."
Discussion: Discuss any questions the participants may
have after performing the activity.
Reference: ARCHITECT System Operations Manual
Application Specialist: It is very important to review five
different types of assay protocols:

1. Assay processing for a one-reagent protocol

2. Assay processing for a two-reagent protocol

3. Assay processing for a dilution protocol

4. Assay processing for a pretreatment protocol

5. Assay processing for a an ICT protocol

9-6 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 9: Basic Sample Progression

Module 9: Basic Sample Notes

Progressions

Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.

1. ICT sample processing uses all of the following except:


a) An ICT module
b) ICT Reference Solution
c) c8000 Sample Probe
d) R2 reagent probe

2. Assay sample progressions, (for all assays), include all of the


following except:
a) c8000 Sample Probe
b) R1 Reagent Probe
c) Cuvettes
d) R2 Reagent Probe

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 9-7
Module 10: QC Analysis
\

Notes

Module 10: QC Analysis

Estimated Time: [25 minutes]

Objectives: • View QC summary review screen

• View QC Analysis report

• View Levey-Jennings graphs

• Display the value of a Levey-Jennings


point

• Include or exclude a Levey-Jennings point

• Add a comment to a Levey-Jennings point

Module Description

This module is a short summary of the types of control analysis


you can view on the c8000. You will learn the key points
presented on the QC summary and Analysis report, as well as
an overview of the Levey-Jennings graph.

Module Topic:

• Analyze QC Data
 QC Summary and Reports
 Levey-Jennings Graph

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 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.

Demonstration: Levey-Jennings Graph Screen

• Display the Levey-Jennings graph screen and discuss the


significance of the various graphic elements

• Refer to the Abbott ARCHITECT® c8000 Chemistry Customer


Training Guide, Module 10 for further information.

Resources

• ARCHITECT System Operations Manual

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Module 10: QC Analysis

Activity: Using KM for troubleshooting Notes

Application Specialists
Purpose: To become proficient at 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

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 10-3
Module 10: QC Analysis

Notes
Module 10: QC Analysis

Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.

1. Where can you review the QC results?


a) QC-Cal Menu>QC result review
b) QC-Cal Menu>QC summary
c) QC-Cal Menu>Levey-Jennings graph
d) QC-Cal Menu>Stored QC results
e) All of the above

2. What do you need to do if you want to omit a QC result?

10-4 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 11: Additional Maintenance
\

Notes
Module 11: Additional
Maintenance

Estimated Time: [165 minutes]

Objectives: • View Weekly, Monthly, Quarterly, and


As-Needed Maintenance procedures

• Perform Weekly Maintenance procedures

• Perform Monthly Maintenance procedures

• Perform Quarterly Maintenance


procedures

• View the Maintenance Log

• Explain the Maintenance Log approval


process

• Interpret Maintenance Log for


troubleshooting

Module Description

• In addition to Daily Maintenance, you also need to be


familiar with the importance of Weekly, Monthly, Quarterly
and As-Needed Maintenance.

Module Topic:

• Weekly, Monthly, and Quarterly Maintenance

• Perform Maintenance Procedures

• Maintenance Log

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 11-1
Module 11: Additional Maintenance

Notes Module 11: Additional


Maintenance

Weekly and Monthly Maintenance


View Weekly, Monthly and As-Needed Maintenance
procedures

• Discuss importance of weekly, monthly, and as-needed


maintenance procedures.
 Ensure efficient and accurate operation of instrument.

• Refer to the Customer Training Guide for further information

Resources

• ARCHITECT System Operations Manual

Demonstration Maintenance Log Screen

Show participants the Maintenance log screen while


discussing what the log displays, how to add a comment and
how the log is approved.

References:

Refer to the Maintenance Log section in module 11 of the


Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

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Module 11: Additional Maintenance

Module 11: Additional Notes

Maintenance

Perform Maintenance Procedures


Demonstration: Weekly Maintenance
Weekly Maintenance procedures are manual cleaning tasks,
including:

• Check ICT components

• Clean mixers

• Clean sample/reagent probes

• Clean cuvettes with detergent

• Check high concentration waste pump tubing

Activity - Weekly Maintenance

Purpose: To become proficient at performing Weekly


Maintenance procedures.
Actions: Have participants complete all weekly
maintenance activities.
Discussion: Discuss any questions the participants may
have.
Resources: ARCHITECT Systems Operations Manual, section
9

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 11-3
Module 11: Additional Maintenance

Demonstration: Monthly Maintenance


Notes
• Check Dispense Components

• Cleaning cuvette washer nozzles

• Checking syringes and valves for leaks

• Cleaning ICT drain tip

Activity - Monthly Maintenance

Purpose: To become proficient at performing Monthly


Maintenance procedures.

Actions: Have participants complete all monthly


maintenance activities.

Discussion: Discuss any questions the participants may


have.

Resources: ARCHITECT Systems Operations Manual, section


9

Demonstration: Quarterly Maintenance

 Change Lamp

 Sample Syringe Maintenance

 Wash Syringe Maintenance

 Reagent Syringe Maintenance

 Change 1 mL Syringes

 Change ICT Asp Check Valve

 Check ICT Ref Check Valves

 Check/Clean HC Waste Sensor

 Clean Reagent Supply Centers

 Clean Sample Carousel/Area

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Module 11: Additional Maintenance

Activity: Perform Quarterly Maintenance Notes

Purpose: To become proficient at performing all quarterly


maintenance procedures.
Actions: Quarterly maintenance for the cSystem is required
on the processing module only. Perform these procedures
quarterly:
 1003 Change Lamp, page
 6301 Sample Syringe Maintenance
 6302 Wash Syringe Maintenance
 6303 Reagent Syringe Maintenance
 6304 Change 1 mL Syringes
 6305 Change ICT Asp Check Valve
 6306 Check ICT Ref Check Valves
 6307 Check/Clean HC Waste Sensor
 6011 Clean Reagent Supply Centers
 6013 Clean Sample Carousel/Area
Discussion: Discuss any problems the class had performing
the activity.
Resources
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide
Reference:
 ARCHITECT System Operations Manual, section 9

Demonstration: Perform As-Needed Maintenance

• Discuss purposes of as-needed maintenance.


 Troubleshoot instrument in response to an operating
error.

• Discuss tasks included in as-need maintenance:


 Flushing fluids, priming fluids, and checking system
hardware.
 RSH specific tasks

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 11-5
Module 11: Additional Maintenance

Demonstration: Viewing the Maintenance Log


Notes
• Show participants the Maintenance log screen while
discussing what the log displays, how to add a comment
and how the log is approved.

• The log stores maintenance information for the last 12


months. If you want to keep a record of maintenance
information for longer period of time, you have the option
of printing the Maintenance History Report.

Activity: Approving the Maintenance Log

Purpose: To become proficient at reviewing and approving


the maintenance log.
The System Administrator reviews and approves the
Maintenance log on a regular basis.
The Maintenance log for the previous month is available for
approval at the beginning of the following month.
Comments may still be made after the log is approved, but
will reflect the date and time of the original approval.
Actions: Have participants review and approve a
maintenance log..
Discussion: Discuss any problems the class had performing
the activity.
Resources
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide
 ARCHITECT System Operations Manual

Demonstration: Maintenance Log in LogIC Troubleshooting

Purpose: Introduce the use of Log-IC tool.


Resources:
 ARCHITECT System Operations Manual
Additional Training Resources:
 Maintenance log from LogIC example file
 Refer to the appendix for an example of the LogIC
maintenance log.

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Module 11: Additional Maintenance

Notes
Module 11: Additional
Maintenance

Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.

1. Which of the following is part of Monthly Maintenance for


the c8000?
a) Clean mixers
b) Cleaning cuvette washer nozzles
c) Clean sample/reagent probes
d) Clean cuvettes with detergent
e) Check high concentration waste pump tubing

2. Reviewing and checking that the syringes, solenoid valves,


and their connections do not leak is part of Quarterly
Maintenance.
a) True
b) False

3. When is As-Needed Maintenance necessary?

4. When do you need to perform Sample Pipettor


Calibration?

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 11-7
Module 12: Common Errors and Troubleshooting

Module 12: Common


\

Notes

Errors and
Troubleshooting
Estimated Time: [150 minutes]

Objectives: • Explain the troubleshooting approach

• Describe and troubleshoot common errors

• View the error message logs

• Use diagnostic procedures for processing


module and RSH

• Use service tools to support instrument


troubleshooting

Module Description

This module describes troubleshooting approach and


common errors. You will also gain skills to effectively
troubleshoot common instrument operational problems.

Module Topics

• Troubleshooting Approach

• Error Codes, Error Messages

• Common Errors and Troubleshooting

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 12-1
Module 12: Common Errors and Troubleshooting

Notes Module 12: Common Errors and


Troubleshooting

Troubleshooting Approach
FORT Troubleshooting Approach

• FORT stands for Fluidics, Optics, Robotics, Temperature, and


refers to identifying the area to perform troubleshooting on.

• Review the FORT model and guide participants to go


through FORT troubleshooting steps. Identify the FORT
category and then system components to assist in
troubleshooting assay related issues:
 One reagents versus two reagents
 STEP Troubleshooting Model
 eSolutions
 KMS
 Service and Support Manuals
 TSB/ISA database
 STEP = Stop, Think, Evaluate, Proceed
Resources
 ARCHITECT System Operations Manual

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Module 12: Common Errors and Troubleshooting

Demonstration: Accessing the Online Help F7 Error


Notes
• Review how to locate error codes in ARCHITECT System
Operations Manual – review categories of error codes and
listing by number.

• Review common Diagnostic Procedures available for


troubleshooting.

Demonstration: Systematic Process for Approaching


Troubleshooting Error Codes

• Review the systematic process for approaching


troubleshooting error codes and observed issues.

• Review the table of common errors in the training guide.

Resources:
 ARCHITECT Systems Operations Manual

Error Codes

• Every error message that the system displays has a specific


code. See the Operations Manual for a list of the codes.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 12-3
Module 12: Common Errors and Troubleshooting

Errors on the c8000


Notes
 General error codes (0001-0999)
 Assay-specific error codes (1000-1999)
 Maintenance error codes (2000-2999)
 Level sense error codes (3000-3999)
 Bar code reader error codes (4000-4999)
 Robotic and sensor error codes (5000-5999)
 Optics error codes (6000-6999)
 Temperature error codes (7000-7999)
 Computer hardware error codes (8000-8999)
 Software error codes (9000-9999)

Error Messages

• The System logs screen on the SCC allows you to access


and view previous error messages that displayed on the
system, as well as previous system software updates.

Diagnostic Procedures

• Discuss purpose of diagnostic procedures.


 Used for more advanced troubleshooting on hardware
and configuration issues.
Resources:
 ARCHITECT System Operations Manual

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Module 12: Common Errors and Troubleshooting

Common Errors and Troubleshooting


Notes
• Discuss the list of common errors on ARCHITECT c8000
Customer Training Guide Module 12: Common Errors and
Troubleshooting. Discuss their impact and resolution.

• Discuss the Top Customer Failure list from MyGSS Global


Service Reports (GSR).

Activity: Perform Troubleshooting

Purpose: To become proficient at performing


troubleshooting.
Actions:
 Perform Activity Module 12: Abbott ARCHITECT c8000
Chemistry Customer Training Guide, near the end of
Module 12.
Discussion:
 Discuss any problems the class had performing the
activity.
Resources:
 Abbott ARCHITECT c8000 Chemistry Customer Training
Guide, Module 12.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 12-5
Module 12: Common Errors and Troubleshooting

Notes Module 12: Common Errors and


Troubleshooting

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. Operational issues on the instrument produce either an


error code message or are observable errors or abnormal
system functions. What is an example of an observable
problem that would not produce an error message?

2. Which description is correct regarding Error Messages?


a) Error messages from operating issues are stored in
temporary messages only.
b) The temporary message log holds non-critical error
messages that you cannot delete.
c) The message history log stores all non-temporary error
messages.
d) The temporary holds 300 messages.

3. Which numbers are Level-Sense error codes?


a) 1000-1999
b) 3000-3999
c) 5000-5999
d) 7000-7999

12-6 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 13: Basic Component Replacement

Module 13: Basic Notes

Component
Replacement
Estimated Time: [60 minutes]

Objectives: • View procedures for component


replacement

• Replace components as needed

Module Description

In addition to consumables and accessories, there are certain


parts on the ARCHITECT c8000 that will wear out due to use
over time. This module shows you some of those common
component parts and where to find the procedures for repair
and replacement.

Module Topics

• View procedures for component replacement

• Replace components

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 13-1
Module 13: Basic Component Replacement

Notes Module 13: Basic Component


Replacement

Replace System Components


Replaceable Components Overview

• Identify additional normal wear/replaceable components:


 Pipettor probes and tubing (sample and reagent)
 ICT module or probe
 Syringes

• Additional normal wear replaceable components


 Cuvettes and cuvette segments
 Lamp or lamp plate
 Cuvette dry tip
 Mixer
 Solution filters
 Check valves
 Syringe o-ring and seal tips
 Pump poppet valve set

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Module 13: Basic Component Replacement

Resources:
Notes
 KM FAQ section, R&R Video Procedures/Select c8000
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide, Module 13 Basic Component Replacement.

Demonstration: Replacing Components

• Refer to the customer replaceable components list and


replacement instructions in ARCHITECT System Operations
Manual

Activity: Perform Common Component Replacements

Purpose: To become proficient at replacing components.


Actions: Complete Activity: Perform Common Component
Replacements, Abbott ARCHITECT® c8000 Chemistry
Customer Training Guide, near the end of Module 13.
Discussion: Discuss any problems the class had performing
the activity. Resources
 Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 13-3
Module 13: Basic Component Replacement

Notes Module 13: Basic Component


Replacement

Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.

1. Where are the steps for replacing the lamp located?


(check all that apply)
a) The ARCHITECT Operations Manual
b) MyGSS\Product Family\Architect\Service
Information\Service Manual
c) KM-FAQ’s
d) ARCHITECT As Needed Maintenance Procedures
e) ARCHITECT Quarterly Maintenance Procedures

2. What procedures need to be performed after replacing


the ICT Module? (check all that apply)
a) Perform “As Needed Maintenance” procedure 6063-
Flush ICT Module
b) Update Inventory Status
c) Inspect probe and tubing for leaks and drips
d) Update Quarterly Maintenance

3. What verification steps must be performed after changing


the Sample Probe?

4. Where did you find this information?

13-4 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 14: Configuring Options

Notes
Module 14: Configuring
Options
Estimated Time: [180 minutes]

Objectives: • View and edit configuration settings for


system, assays and quality control.

Module Description

This module briefly shows ways to customize the ARCHITECT c8000


for your needs through configuration settings.

Module Topics

• System Configuration Settings

• Assay Configuration Settings

• QC-Cal Configuration Settings

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 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.

• Three areas for configuration settings:


 System configuration settings
 Assay configuration settings
 QC-cal configuration settings

• Refer to Module 14 Configuration Options, in the Abbott


ARCHITECT® c8000 Chemistry Customer Training Guide for
further information.
Resources
 ARCHITECT System Operations Manual

Demonstration: System Configuration

System Configuration Settings

• Log in as ADMIN or higher for system configuration.

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Module 14: Configuring Options

• Sample Ordering
Notes
 Configure settings for:

 Batch ordering
 Calibration ordering options
 Control ordering options
 Average tests per sample

References:

 Refer to Module 14 Configuration Options, in the


Customer Training Guide for further information.

• Host - Release Mode

• Reagents - Supplies

 Reagent Options

 Supply Options

• Password

• System Control Center

• Modules

• Sample Handler

 RSH Options:

 Automatic reposition samples for retest

• Barcodes

• Serial Ports

• TCP/IP Ports

• Premium Software

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 14-3
Module 14: Configuring Options

Notes Activity: Configure System Settings

Purpose: To become proficient at configuring system


settings.
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

Assay Configuration Settings

From the Assay settings view of the Configuration screen, the


System Administrator can configure settings associated with
assays.

• Assay Parameter Options:


 General settings
 Assay name, number and availability
 Assay and calibration version
 Run controls by reagent lot or reagent kit
 Calibration
 Method for calibration, data reduction and
calibration adjustment
 Calibrator replicates
 Calibrator names and concentrations
 Calibration interval
 Dilution
 Default dilution
 Dilution options
 Results
 Age and gender specific ranges
 Normal and extreme ranges

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Module 14: Configuring Options

 Edit or delete ranges


Notes
 Linearity range
 Interpretation
 Name
 Range
 Requirement to view result

New Assay

• New Assay Options:


 Assay type
 3rd party assay - country specific

Result Units

• Result Units Options:


 Result units
 Decimal places

Panel Definitions

• Panel Definition Options:


 Panel name
 Panel type

NOTE: You cannot use an existing panel to create a new


panel. You must add each test individually.

Retest Rules

• Retest Rules Options:


 Rule name
 Replicates
 Retest indicator
 Result range
 Original dilution
 Retest assays
 Retest dilution

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 14-5
Module 14: Configuring Options

Assay Display Order


Notes
• Assay Display Order Options:
 Reports only
 Displays and reports

Activity: Configure Ranges and Panels

Purpose: To become proficient at configuring ranges and


panels
Actions:

1. Add the following reference ranges to Glucose for females


age 13 to 100:
 Normal range = 70 - 110
 Extreme range = 30 LL to 250 HH

2. Add the following reference ranges to Glucose for males


age 13 to 100:
 Normal range = 80 - 120
 Extreme range = 20 LL to 300 HH

3. Highlight GluC and print Assay Parameter Report.

4. Set Urea results with >20 to have CreaC run.

5. Set GluC results >500 to be rerun with a 1:5 dilution.

6. Configure a panel:
 Panel name = Dr. Gray
 Panel type = Patient
 Assays: Na-C, K-C, Cl-C, GluC
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual

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Module 14: Configuring Options

QC-Cal Configuration Settings


Notes
• From the QC-Cal settings view of the Configuration screen,
the General Operator can access windows to view
detailed information for configured QC-Cal settings.
QC Single Analyte

• QC Single Analyte Options:


 Control level name
 Lot number
 Expiration date
 Default dilution
 Bar code SID
 Display order
 Manufacturer mean and 1 SD
 Expected mean and 1 SD control range
 QC time interval
 QC test count interval
 Calibrator names and concentrations
QC Multiconstituent

• 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
 QC test count interval
Multiconstituent bar code SID

• MCC Barcode Options:


 ID

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 14-7
Module 14: Configuring Options

 Control
Notes
 Lot
 Level
 Assays
Westgard Rules

• Westgard Rules Options:


 Rules
 Disable/Enable
 Flag type
NOTE: Westgard rules configured as a “warning” do not
produce a flag for patient results. Westgard rules
configured as a “failure” produce a CNTL flag for patient
results and subsequent control results.

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Module 14: Configuring Options

Activity: Configure QC Notes

Purpose: To become proficient at changing configuration


settings
Actions: Perform Activity 1: Module 14, Abbott ARCHITECT®
c8000 Chemistry Customer Training Guide, near the end of
the module.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual

Activity: HIL Activity

Purpose: To become proficient at loading the HIL assay


from the assay disk.
Actions:
a) Choose SYSTEM Navigation Key – Choose Diagnostics
Menu
b) Select the SCC (5)
c) Arrow down
d) Choose Utilities
e) Choose install delete assays – (if using CD)
f) Insert CD into CD Drive
g) Select Install
h) Choose option for CD ROM (CD ROM) Proceed
i) From the menu choose Interferences
j) Install all assays
k) Return to Main Menu and Exit to save
l) Configure assay as detailed below.

Configuration of HIL Indices from Hard drive (pushed through


Abbott Link
a) Choose SYSTEM Navigation Key – Choose Diagnostics
Menu
b) Select the SCC (5)
c) Arrow down

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Module 14: Configuring Options

d) Choose Utilities
Notes
e) Choose install delete assays
f) Select Install
g) Choose option for correct e-assay files (Hard Drive)
Proceed
h) From the menu choose Interferences
i) Install all assays
j) Return to Main Menu and Exit to save
k) Configure assay as detailed below.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual

Activity: Build a 3rd Party Assay

Purpose: To be familiar with process of preparing and


building 3rd party assay files.
Actions: To build a 3rd party assay manually as directed by
instructor.

• Instructor will provide protocols for participants in this


activity.

• Once loaded, participants will print a list of all assays


installed on ARCHITECT (Diagnostic Procedure 6029.)
Discussion: Review key steps and potential issues of building
3rd party assay installation.
Resources:
 ARCHITECT System Operations Manual, section 2,
Installation Procedures and Special Requirements

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Module 14: Configuring Options

Activity: Add Assay Notes

Purpose: To practice viewing and changing configuration


settings.
Actions: Perform optional Activity 3 at the end of Module
14, Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 14-11
Module 14: Configuring Options

Notes
Module 14: Configuring Options

Review
Review questions in the corresponding module of the
Abbott ARCHITECT® c8000 Chemistry Customer Training
Guide.

1. Which of the following configurations cannot be done


while the instrument is in a running status?
a) Configuring a new lot of calibrator.
b) Changing a printed report configuration from off to on.
c) Changing a batch from barcoded to non-barcoded
d) Changing the LIS from on to off

2. Certain flags are printed on the sample and patient reports


whether the report flagging feature is turned on or off.
a) True
b) False

3. What is the function of a retest rule? (Select all that apply)


a) To run original patient results in duplicate.
b) To repeat samples with a specific set of error codes.
c) To repeat samples that generate specific numeric
results.
d) The ARCHITECT is not capable of using retest rules.

4. What user should you be logged in as in order to be able to


change configurations? (Check all that apply.)
a) General Operator
b) Admin
c) FSE

14-12 Global ARCHITECT c8000 Application Training Program | Global Service Training | 80000617-101
Module 15: System Utilities
\

Notes
Module 15: System
Utilities
Estimated Time: [25 minutes]

Objectives: • View previously installed software updates

• Backup the system software

Module Description

This module reviews some of the system tools for keeping the
ARCHITECT c8000 software up-to-date and backed up.

Module Topics
 System Logs
 Software Backup

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Module 15: System Utilities

Notes
Module 15: System Utilities

System Utilities

System Backup

• View system backup: Use software update log to show a


historical view of system software updates.

Archive Stored Patient Results

• Discuss benefits of archiving stored patient results.

 A long-term storage and a backup when system


reaches maximum capacity.

• Discuss the difference between archives and backups.

 A long-term storage and a backup when system


reaches maximum capacity.

Demonstration: System Utilities Screen, Software Backup


 Software install

 System updates

 Backup software

• Discuss when to perform a software backup

 After calibrations

 After changing configuration settings

 After adding new assays

 According to your facility’s protocol

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Module 15: System Utilities

Activity: Backup Software Notes

Purpose: To become proficient at performing a software


backup.
Actions: Perform a software backup.
Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual

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Module 15: System Utilities

Notes
Module 15: System Utilities

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. What is the purpose of the software update log?


a) To ensure that the system has been updated.
b) Shows a historical view of updates to the system
software.

2. You can create a total of _____ software backups.


a) 5
b) 7
c) 3

3. List the steps for performing a complete Arch backup

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Module 16: Abbott Tools and Resources
\

Notes
Module 16: Abbott Tools
and Resources
Estimated Time: [25 minutes]

Objectives: • Open and view Abbott Mail

• Describe the function of AbbottLink

• Describe some of the benefits of Premium


Package

Module Description

The ARCHITECT c8000 comes with many beneficial features


and functions. Abbott provides some additional tools that you
can choose to use in your facility. This module discusses some
of those resources.

Module Topics

• Abbott Tools and Resources

• Premium package benefits

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Module 16: Abbott Tools and Resources

Notes Module 16: Abbott Tools and


Resources

Abbott Tools and Resources


• Abbott Mail is an email resource available through the
System menu on the SCC.

• With AbbottLink available, you can connect directly to


Abbott Laboratories for immediate downloads of software
updates.

• At the AbbottDiagnostics.com website, the My Lab


Customer Portal provides access to technical documents.

Demonstration: Premium Software Package Elements

• Demonstrate Abbott Mail

• Discuss features and benefits of AbbottLink

• Discuss benefits of Premium software packages


Purpose: To become proficient at using Abbott Email

Activity: Check Abbott Email

Actions: Check Abbott mail.


Discussion: Discuss any problems the class had performing
the activity.
Resources:
 ARCHITECT System Operations Manual, What’s New
section

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Module 16: Abbott Tools and Resources

Module 16: Abbott Tools and Notes

Resources

Review
Review questions in the corresponding module of the
Abbott ARCHITECT c8000 Chemistry Customer Training
Guide.

1. Name some features of the Premium Benefits Package.

2. List four functions of AbbottLink.

Global ARCHITECT c8000 Application Training Program | Global Service Training| 80000617-101 16-3
Final Assessment Activities

Notes
Final Assessment
Activities
Estimated Time: [300 minutes]

Objectives: • Assess ARCHITECT c8000 Instrument


Knowledge and Operational Skills via
Troubleshooting Activities and Final Written
Exam

Module Description

This module focuses on final assessment activities. There are


two parts of assessments:

• Troubleshooting Practical and final exam.

• Troubleshooting Practical will be completed at the


instrument.

• Final exam will be completed on the LMS.

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Final Assessment Activities

Notes
Final Assessment Activities

Complete Troubleshooting Practical


Activities
• Demonstrate proficiency in all of the major areas of the
instrument by successfully completing the operational and
troubleshooting activities.

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Final Assessment Activities

Troubleshooting Practicals(3 Hours)


Notes
Purpose: To demonstrate competency in performing
instrument operational tasks and troubleshooting.
Actions: Perform the following steps:
a) Cycle power (on/off)
b) Check supplies
c) Run Daily Maintenance
d) Perform calibration
e) Configure a new control file
f) Run controls
 Run a sample as a patient designated by the instructor

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Final Assessment Activities

Notes
Final Assessment Activities

Complete the Final Written Assessment


• Demonstrate Competency in Performing Instrument
Integration Scoring of 80% or Higher on the Final
Assessment.

Written Final Assessment (60 Minutes)

• LMS - Final Assessment – Participants should login to the


Knowledge Platform System (LMS) and complete the HEM
Integration Global Training Program Exit Exam and Course
Survey.

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Final Assessment Activities

Final exam with answer keys will be available from Global


Notes
Application SharePoint,.

The Final Exam is made up of multiple choice questions pulling


from a question pool, assessing knowledge in EP Evaluator,
Pre-Integration activities, Post-integration activities,
Verification/Validation Studies, troubleshooting, assay
installation, My GSS resources, and AbbottLink.

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Appendix
List of most common error messages
1. ERROR 3375 - Unable to process test, aspiration error occurred.

2. ERROR 6512 - Optics system warning, fluctuation detected, bichromatic check

3. ERROR 6513 - Optics system failure, fluctuation above maximum range,


bichromatic check.

4. ERROR 5018 - Sample pipettor movement restricted at sample carrier.

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

7. ERROR 7510 - Reagent 1 supply center temperature above maximum range

8. ERROR 7514 - Reagent 2 supply center temperature above maximum range.

9. ERROR 3579 - Internal Low concentration waste tank is full.

10. Issues with Reagent barcode readers

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General Error Code Ranges
1. General error codes (0001-0999)

2. Assay specific error codes (1000-1999)

3. Maintenance error codes (2000-2999)

4. Level sense error codes (3000-3999)

5. Bar code reader error codes (4000-4999)

6. Robotic and sensor error codes (5000-5999)

7. Optics error codes (6000-6999)

8. Temperature error codes (7000-7999)

9. Computer hardware error codes (8000-8999)

10. Software error codes (9000-9999)

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Instrument Component Overview
Figure 1: Primary components of the c8000 System

1. Processing Module

2. RSH - Robotic Sample Handler

3. SCC - System Control Center

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Figure 2: c8000 Processing Center Components

Answer Key
1
2
3

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Figure 3: c8000 Sample Hardware Components

Answer Key
1
2
3
4
5

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Figure 4: c8000 Processing Center

Identify the components by writing their names next to the corresponding letter.

Answer Key
1
2
3
4
5
6
7

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Maintenance Log Screen

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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.

Please refer to cSystems Comparison Table:


http://adcollab.oneabbott.com/add/gss/ARCHITECT/Product%20Family%20Documents/80000268‐101.pd
f

cSystem Data Reduction Methods


The ARCHITECT cSystem uses photometric and potentiometric technology to
measure analyte concentrations in samples. Data reduction/calibration methods
are specific to the technology type.

• cSystem data reduction methods topics include:


 Photometric data reduction methods
 Potentiometric data reduction method

Photometric data reduction methods

Photometric data reduction/calibration methods analyze photometric read data


to calculate results.

Photometric data reduction methods include:

• Absorbance method (photometric)

• Factor method (photometric)

• Linear method (photometric)

• Logit-4 method (photometric)

• Spline method (photometric)

• Use factor and blank method (photometric)

Absorbance method (photometric - cSystem)

• The absorbance data reduction method uses the comparison between the
absorbance of the sample and the absorbance of water to calculate results.

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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.

Factor method (photometric - cSystem)

• 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.

• The enzyme activity or sample concentration is calculated using the following


equation:

• 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.

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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

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• When Ac1 < A Ac2

• X = F2 × (A - Ac1) + C1

• When Ac2 < A Ac3

• X = F3 × (A - Ac2) + C2

• When Ac3 < A Ac4

• X = F4 × (A - Ac3) + C3

• When Ac4 < A Ac5

• X = F5 × (A - Ac4) + C4

• When Ac5 < A

• X = F6 × (A - Ac5) + C5

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• 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.

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Figure: 6. Logit-4 calibration curve - three to six calibrators

Legend:

• blk Concentration of the reagent blank

• C1 to C(n) Concentration of calibrator

• X Concentration of unknown sample

• Ablk Absorbance or absorbance change of the reagent blank

• Ac1 to Ac(n) Absorbance or absorbance change of the calibrator

• A Absorbance or absorbance change of the unknown sample

• The equation used in the approximation is:

Global ARCHITECT c8000 Application Training Program| Global Service Training| 80000617-101 18-13
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

• When the concentration is close to 0, the Logit-4 calibration curve converges


asymptotically toward the absorbance or absorbance change of the reagent
blank as the concentration approaches 0. This convergence may not show on
the graph if the scale is too large.

• The approximation expression is simple and the constant is determined through


approximation by non-linear regression. Therefore, the curve may not always
pass through the absorbance (or absorbance change) data points of the
calibrator.

• It is possible to set a parameter to detect an error if the SD (standard deviation)


of the absorbance or absorbance change of the calibrators exceeds the user
specified value.

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.

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Figure: 7. Spline calibration curve - three to six calibrators

Legend:

• blk - Concentration of the reagent blank

• C1 to C(n) - Concentration of calibrator

• Ablk - Absorbance or absorbance change of the reagent blank

• Ac1 to Ac(n) - Absorbance or absorbance change of the calibrator

• The polynomial equation used is:


Where:
 A = Absorbance or absorbance change of the sample (unknown)
 a(n), b(n), c(n), d(n) = Constants of the approximation expression
 X = Concentration of sample (unknown)

Use factor and blank method


The use factor and blank data reduction method uses the factor and reagent
blank of a calibration curve generated for another assay (reference assay) to

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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.

Figure: 8. Use factor and blank - linear calibration curve

Legend:

blk - Concentration of the reagent blank

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

C1' - Concentration of the calibrator used for the reference test

The equation used is:

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Potentiometric data reduction method

• The potentiometric data reduction method analyzes electrical potential data


to calculate electrolyte results.

• There are three components to the potentiometric method:

• Electromotive force measurement

• Slope calculation

• Sample measurement

Electromotive force measurement


The electromotive force measurement uses the difference (potential
difference) between the electromotive force of an unknown sample and the
electromotive force of the ICT Reference Solution, measured immediately after
the sample, to determine electrolyte concentration.

Figure: 9. Electromotive force calculation

ΔEi = Potential difference between the sample and ICT Reference Solution for
each electrode
= Potential of each electrode (i), in contact with ICT Reference
Solution

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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:

• Calibration graph showing the relationship of the ion electrolyte concentration


to the electromotive force

• Electrode response curve during calibration

Figure: 10. Relationship between ion electrolyte concentration


and electromotive force

Where:
 S = Slope (mV/decade) of each electrode

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 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

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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

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• The following equation is used:

Figure: 12. Electrode (mV) response curve during sample


measurement

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

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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.

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ICT Fluidics Flow
Figure 13: ICT Fluidics Flow

Step 1: The sample and reagent are dispensed


Step 2: The sample is analyzed.
Step 3: Waste is removed.

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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

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