C16000 App Trainning

Global ARCHITECT c16000
Application Training
Program
Participant Guide
Overview
Table of Contents
Modules
Global ARCHITECT c16000 Application Training Program | Global Service Training|80000618-101

Revision History
REVISION STATUS
Document Revision Date Content or Pages Revised, Added, or
Control Deleted
Number
80000618-101 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.
Preface - 2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Training Overview
Training Overview
The ARCHITECT c16000 Application Training Program is designed to provide Global

Application Specialists with instrument knowledge and skills needed to perform
effective ARCHITECT c16000 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 c16000 system.
• Explain the basic process of the ARCHITECT c16000.
• 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 c16000 Instrument Overview
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Preface - 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 learners and not intended to be
taken as part of pre-work activity.
Materials
The Global ARCHITECT c16000 Application Training Class will be presented by

facilitators using the following materials:
 ARCHITECT System Operations Manual
 ARCHITECT c16000 Service and Support Manual
 Abbott ARCHITECT c16000 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
How to Use This Guide
The ARCHITECT c16000 instrument has been designed for optimum operator
safety. However, this does not reduce the importance of safety awareness where
hazards exist. This section describes the types and locations of potential hazards
that could cause physical harm or damage to the laboratory environment or
where failure to follow instructions may result in instrument failure or generation of
erroneous patient results.
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 c16000 Safety Hazard Information

Biological Hazards
Chemical Hazards
Electrical Hazards
Electrostatic Discharge (ESD)
Hazards
Laser Light
Overview
Safety Icons and Hazard Symbols
• 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.
Black Text
• The black text will appear in both Facilitator Guide and Participant Guide.
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Preface - 5
Resources
• Resources in black will appear in both the Facilitator and Participant Guides.
The resources are hyper links that, when selected, will take you to the location
of the specified document or resource.
Blue Text
• Text that appears in blue is intended for Application Specialists only. This
indicates tasks and activities they do as part of the role, but is NOT intended for
customers to perform.
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.
Contents
Contents
Revision History ...................................................................................................i-2
Getting Started GS-1

ARCHITECT c16000 Application Training Overview....................................GS-2
Use Service Tools ............................................................................................GS-4
Review.............................................................................................................GS-6
Module 1: Overview of the ARCHITECT c16000 System 1-1

PM - Processing Module .................................................................................. 1-4
RSH - Robotic Sample Handler ....................................................................... 1-6
SCC - System Control Center ......................................................................... 1-6
Review............................................................................................................. 1-10
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........................................................................................................... 3-4
Review............................................................................................................... 3-9
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
Review............................................................................................................. 6-12
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 TOC-1
Contents
Module 7: Quality Control 7-1

Quality Control ................................................................................................. 7-2
Review............................................................................................................... 7-5
Module 8: Patient Sample Orders 8-1

Patient Sample Order Types ........................................................................... 8-4
Review............................................................................................................... 8-9
Module 9: Basic Sample Progression 9-1

Photometric and Potentiometric Measurement Methods.......................... 9-2
ICT Fluidics......................................................................................................... 9-3
Review............................................................................................................... 9-7
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............................................................................................................. 12-7
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
Assay Configuration Settings ........................................................................ 14-4
QC-Cal Configuration Settings..................................................................... 14-7
Review........................................................................................................... 14-12
TOC-2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Contents
Module 15: System Utilities 15-1

System Utilities ................................................................................................. 15-2
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 c16000 Application Training Program| Global Service Training| 80000618-101 TOC-3
Getting Started
Notes
Getting Started
Estimated Time: [75 minutes]
Objectives: • Discuss the Overview of ARCHITECT c16000

Global Application Training Program
• Demonstrate proficiency in using MyGSS

service tools
Module Description
This module provides an overview of ARCHITECT c16000

Application Training Program, expected training outcomes,
and use of service tools.
Module Topics
• ARCHITECT c16000 Application Training Program overview
• Use of service tools
Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101 GS-1
Getting Started
Notes
Getting Started
ARCHITECT c16000 Application Training

Overview
Discuss Overview of ARCHITECT c16000 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 c16000 Application Training Program | Global Service Training | 80000618-101
Getting Started
• Safety Concerns
Notes
 It is important to wear gloves, lab coats, and protective
eye wear when handling human sourced material or
contaminated instrument components.
 If the possibility of pressurized liquid exists, or if significant
force is needed to perform operations where liquid may
be present, full-face protection is recommended.
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 KM – Knowledge
Management.
 Are you able to filter the results for the c16000
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. Verify the reagents are
loaded.
 What general information is provided if you choose
Technopath controls?
Discussions: Check understanding of KM tool and key
features.
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 c1600962.
 Access message history and historical data for an
ARCHITECT c16000.
 Retrieve the Troubleshooting Pack 1 for the ARCHITECT
c16000.
 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
Getting Started
Notes
Getting Started
Review
Review questions in the corresponding module of the
Abbott ARCHITECT c16000 Chemistry Customer Training
Guide.
1. What is an ISA?
a) Interface Statistical Area
b) Information Setup Assistant
c) Instrument Service Advisory
2. What is a TSB?
a) Troubleshooting System Backup
b) Testing Systems Bulletin
c) Technical Service Bulletin
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) Under the eSolutions Troubleshooting Database
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
Module 1: Overview of the ARCHITECT c16000 System
Module 1: Overview of Notes
the ARCHITECT c16000

System
Objectives: • Explain the basic process of the ARCHITECT

c16000
• 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 c16000 Application Training Program | Global Service Training| 80000618-101 1-1
Module Topics:
Notes
 PM - Processing Module
 RSH - Robotic Sample Handler
 SCC - System Control Center
 Online Operations Manual
1-2 Global ARCHITECT c16000 Application Training Program | Global Service Training | 80000618-101
Notes
Module 1: Instrument Overview
Activity: Identifying Components (Application Specialists)
Purpose: To become proficient at identifying components.

Actions: Use the instrument graphics in the Appendix 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 processing center is the main area of activity in the
processing module. Samples and reagents are
dispensed and mixed in a reaction carousel to perform
assay processing.
• 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
 Reagent hardware components

Notes
 Reagent supply centers
 Reagent pipettor 1 and wash cups
 Reagent pipettor 2 and wash cups
 Reagent bar code readers
 Reagent supply center 1 and 2 advance buttons
 Reaction carousel hardware components
 Cuvette segments
 Lamp
 Mixer unit (paired)
 Cuvette washer
 ICT unit
 Water bath/waste overflow area
 ICT waste area
 High concentration waste pump
 Supply and pump center
Supply and Pump Center
• Pump center
• Bulk solutions
• Sample/reagent syringes
RSH - Robotic Sample Handler Notes
• Discuss RSH. Refer to the ARCHITECT Systems Operations

Manual Section 1-8
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:

Notes
 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.
• Review items below:
 Icons - Represents a category of screens. When you

select an icon, a menu displays below the icon.
Windows provides additional details or functions related
to the active screen.
 Menus - Lists the available items for the selected

category.
 When you select a menu item, the associated screen

displays.
 Messages or prompts -Provides informational or error

messages that allow you to complete a procedure or
address the current situation.
 Screens - Provides 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

Notes
 CSC Login
 FSE Login
 General
 System Administrator - Access Levels. User ID=ADMIN,
password=ADM
 Premium feature – System Administrator can create user
specific log on.
Online Operations Manual
• 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.
Notes 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.
Activity: Navigate the SCC
Purpose: To practice logging on and off and printing.

Actions:
 Refer to Activity: Module 1 from the Abbott
ARCHITECT c16000 Chemistry Customer Training
Guide.
Discussion: Discuss questions or issues that arise from
performing the activity.
Notes
Module 1: Instrument Overview
Review
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
Module 2: System Statuses
Notes
Module 2: System
Statuses
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
Notes
System Statuses and their Meanings

• Discuss the meaning of each of the 8 status types and what
is happening when that system status displays. Refer to the
table in the Abbott ARCHITECT c16000 Chemistry Customer
Training Guide.
 Offline
 Stopped
 Ready
 Running
 Scheduled Pause
 Initializing
 Scanning
 Maintenance
• Review System status sequence graphic in the Abbott

ARCHITECT c16000 Chemistry Customer Training Guide.
• Review how to change between 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 c16000 Chemistry
Customer Training Guide.
Activity: Change System Statuses
Purpose: To be proficient in changing system statuses.

Actions:
 Complete the activity at the end of Module 2 in the
Guide.
Discussion: Highlight key steps of changing system status.
Resources
Notes
Review
1. Review questions in the corresponding module of the
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 c-system be in to perform

the 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
Module 3: Consumables and Inventory Management
Module 3: Consumables Notes
and Inventory
Management
Objectives: • Explain use and replacement of bulk

solutions, onboard solutions, sample wash
solutions and water bath additive
• Explain when to replace the ICT module
• Prepare 0.5% acid wash and 10%

Detergent B solutions
• Replace and update supplies
• Prepare reagents and load/unload them

on the carousel
• View reagent status and history
Module Description
This module covers the supplies and accessories you will use to
run the ARCHITECT c16000. You will replenish these supplies
frequently in the instrument and update the system supply
status.
Module Topics
Notes
• Inventory Management Consumables
 Bulk solutions
 Onboard solutions
 Sample wash solutions
 Water bath additive
 Replacing cartridge solutions
 ICT module
• Supply status
• Update supplies
• Other consumables and accessories
 Sample cups/tubes and carriers
• Reagents
 Reagent Cartridges and Adapters
 Prepare Reagents
 Load Reagents in the Carousel
 Loading and unloading non bar coded reagents
• Reagent status
 Disable reagent
 Onboard stability time
Module 3: Consumables and Notes
Inventory Management
Reagents
ARCHITECT c16000 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.
 Application Specialists: Explain the impact of moving a
reagent from one reagent line to the other reagent line.
Demonstration: Bulk Solutions

Notes
• 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.
• Demonstrate preparing the acid wash dilution or Detergent

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 Carousel Solutions
• 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.
• Application Specialists: Due to high volume usage on a

C16000 it may be needed to load sample wash solutions
into a test tube instead of sample cup, to make it through
24 hour time frame.
• Optional: If time and materials are not available, you can

have participants view any applicable videos in the online
Operations Manual.
Demonstration: Replacing Cartridges in Reagent Carousels

Notes
• Show participants replacement cartridges used for various
solutions and where they typically are placed in the
reagent carousel.
• Demonstrate opening the reagent supply center 1 and 2

covers and using the advance keys.
• Demonstrate the location of the reagent bar code reader.
• Show the participants the various types of reagent

adapters.
• Show the participants the A-line B-line reagent loading and

line balancing concept.
Demonstration: ICT Module
• 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
Notes
 Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide
Demonstration: Calibrators
• Show participants a sample box of calibrator bottles to get

them familiar with calibrator bottles and packaging. Discuss
the different types of calibrators, methods and ICT
calibrators.
Demonstration: Controls
• Show participants a sample box of controls and their

purpose. Mention the two types of controls, but that
learners will cover more about controls in the Quality
Control (QC) module.
Demonstration: Reagents and Carriers
• Show the participants one or two available reagent

cartridges (and any adapters for bottles, if available).
Demonstration: Prepare, Load, and Unload Reagents
• Show the learners how to prepare a reagent cartridge and

load it onto the reagent carousel using the reagent supply
access door. Remind learners that the system needs to be
in Ready (or Scheduled Pause) status to load reagents.
• Show learners the same process for removing or unloading

a reagent from the carousel.
Load Sample Diluent and Non-Barcoded Reagents
• Show participants where on the SCC to load sample diluent

in reagent supply center 1. Remind participants that, for the
c16000, sample diluent needs to be loaded on both the
A-line and the B-line.
Reagent Status
Notes
• Show participants the Reagent Status and Reagent History
Screens.
Activity: Update Supplies and Reagents
Purpose: To become proficient at updating supplies and

reagents
•
Actions: Perform the activity at the end of the Module 3,
Consumables and Inventory.
Resources:
 Abbott ARCHITECT c16000 Chemistry Customer Training
Guide
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)
Notes Module 3: Consumables and

Inventory Management
Review
Guide.
1. In order to load reagents on Architect c-system, instrument

status must be:
a) Stopped or ready.
b) Processing
c) Scheduling Pause
d) a and c are correct.
2. 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.
3. Where do you find reagent handling and storage

requirements?
4. At what time of day or during which shift is it practical to

perform inventory management?
Module 4: Robotic Sample Handler (RSH)
Notes
Module 4: Robotic
Sample Handler (RSH)
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 needed maintenance
procedures.
Module Topic
• RSH Functions
• RSH Bays
• RSH Indicator Lights
• Opening RSH Covers
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
Guide, Module 4 Robotic Sample Handler
Activity: Load Sample Carriers into the RSH Notes
Purpose: To practice loading sample carriers and trays in

the RSH.
Actions:
 Complete the activity in Abbott ARCHITECT c16000
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.
Resources:
Guide, Module 4 Robotic Sample Handler
Activity: RSH Bar Code Calibration
Purpose: To become proficient at calibrating RSH bar

codes reader.
Actions:
 Perform RSH bar code calibration.
 Procedures 1119 Transport Calibration
 Discussion: Discuss other as needed maintenance
procedures.
Notes Module 4: Robotic Sample

Handler (RSH)
Review
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?
Module 5: Daily Maintenance
Notes
Module 5: Daily
Maintenance
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 Topics
• Daily Maintenance
Notes
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 Notes
Purpose: To be proficient at performing maintenance

procedures.
 Perform Daily Maintenance procedure for the
ARCHITECT c16000 Module.
Resources
Notes
Review
Guide.
1. What are the solutions required to perform daily

maintenance
Module 6: Calibrations
Notes
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.
Module Topics
Notes
• Calibrations, Types, Statuses
• Calibration Orders
• Calibration Results and Reruns
• Calibration History and Reports
Notes
Calibration Overview
• Discuss Importance of Calibration and Calibration
Guidelines
 No need to recalibrate assays every time they are run;
only perform when:
 A new reagent lot number is used. In some case and
for some specific assays, calibration has to be done
every time a new cartridge is used even for the same
lot.
 Documentation accompanying a new version of an
existing assay file states calibration is required.
 A new assay file that requires a calibration is installed.
 Calibration stability has expired
Calibration Types
Notes
• The calibration type indicates whether a new calibration
curve is created, a master reference curve is adjusted or a
cutoff value is created for cSystem assays on a processing
module. The type is defined in the assay parameter file and
is assay-specific. The calibration types on the cSystem are:
 Full calibration (default)
 Adjust calibration (1-point, 2-point, blank or none)
• It is important to review section 6 of the operators manual in

regards to Calibration Types (cSystems).
Six Methods of Calibration

There are six different mathematical methods used to
calculate results.
 Absorbance method (photometric - cSystem)
 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.
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
Demonstration: Calibration Status Screen

Notes
• Refer to the Calibration Status Screen information in
Module 6 of the Abbott ARCHITECT® c16000 Chemistry
Customer Training Guide.
Resources:
Abbott ARCHITECT® c16000 Chemistry Customer Training
Guide, Module 6.
Demonstration: Calibration Order Screen
• Show participants the order screens while discussing the

order process, lot numbers and expiration dates.
• Show participants how to calibrate specific kits.
• Demonstrate the possibility to configure a new chemistry lot

(MCC for example).
• Show how to select a new lot when ordering a calibration.
Resources:
• Abbott ARCHITECT® c16000 Chemistry Customer Training

Guide, Module 6.
Demonstration: Calibration Preparation

Notes
• 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:

Guide, Module 6.
Demonstration: Calibration Failures and Troubleshooting
• Purposes: To become proficient at resolving calibration

failures and troubleshooting
• Actions: Show participants the consequences of moving a

reagent from one line to another. Discuss what happens if a
scan is not performed after moving or adding reagents.
• Resources:
Training Guide, Module 6.
Notes Activity: Order Calibrations
Purpose: To become proficient at ordering and reviewing
calibrations.
Actions:
 Have learners review the Calibration status screen on
the SCC.
 Provide the materials and supplies to allow learners to
run the calibration order for that assay. Instruct learners
to review the status during the calibration (Order and
Sample status) as well as the final calibration curve
(Calibration status).Perform the Order Calibrations
activity in the Abbott ARCHITECT® c16000 Chemistry
Customer Training Guide, Module 6.
Reference:
 MyGSS/ARCHITECT/Assay Information - Troubleshooting
Guide Documents
Discussion:
 Discuss any questions participants may have as a result
of performing the activity.
Activity: Troubleshooting Calibration Notes
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.
Demonstration: Calibration Results
• Show participants the Calibration results screens and

review any failed calibration curves and error codes.
Resources:

Guide, Module 6.
Demonstration: Calibration History and Reports

Notes
• 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:

Guide, Module 6.
Activity: Archive Calibrations
Purpose: To become proficient at archiving calibrations.
Actions: Perform the Archive Calibrations activity in the
Guide, Module 6.
Discussion:
 Discuss any questions the participants may have
concerning the activity.
Activity: KM - Search Calibration Information Notes
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.
Notes
Review
Guide.
1. List the 6 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) Yes, every 30 days
b) No, they never expire
c) Assay dependent
d) 14 days
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
Module 7: Quality Control
Notes
Module 7: Quality
Control
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
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.
• 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.
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
Purpose: To become proficient at running control orders
and reviewing QC results.
Actions: Perform the activity in the Abbott ARCHITECT®
c16000 Chemistry Customer Training Guide, Module 7.
Review QC flags in the ops manual.
Discussion: Discuss any questions participants may have
had performing the activity.
Notes Activity - Archive and Delete Old Control Lots
Purpose: To practice archiving and deleting old control lots.
Actions: Perform activity 2 in Module 7 Control (QC) Orders
in the Abbott ARCHITECT® c16000 Chemistry Customer
Training Guide.
Discussion: Discuss any questions the participants may
have concerning this activity.
Resources:
Activity: Using KM for Troubleshooting
Purpose: To become proficient at using KM to search for
instrument related troubleshooting information.
Action: Perform a free text search for 'lithium qc out of
range
have concerning this activity
Resources:
Notes
Module 7: Control Orders (QC)
Review
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?
Module 8: Patient Sample Orders
Notes
Module 8: Patient
Sample Orders
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 c16000: running patient sample orders. An LIS
automates this process, however, you should know how to
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

Notes
 Suspend an Order in Progress
• Patient Results and Reruns

 Review and Release Results
 Result Flags
 Rerun a Test
• Exceptions
 Rerun Exceptions
 Other Order Exceptions
• Stored Results
 Review Stored Patient Results
 Archive Stored Patient Results
Notes Module 8: Patient Sample

Orders
Patient Sample Order Types

Patient Sample Order Types
• Discuss patient sample order types (single, batch, bar

coded or non-barcoded batch, routine vs. 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.
Demonstration: Order Status and Sample Status
• 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® c16000 Chemistry Customer Training Guide.
Activity: Run Patient Sample Orders Notes
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
Discussion: Discuss any problems the class had performing
the activity.
Resources:

Guide
Results and Reruns

 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.
 Demonstrate where to locate the reaction graph under
results detail.
Other Order Functions

Notes
 Discuss other order functions like suspending an order.
Exceptions
 Discuss the exception indicators and what they mean.
 Review rerunning an exception order.
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 Customer Guide the Abbott
ARCHITECT® c16000 Chemistry Customer Training Guide,
Module 8.
the activity.
Resources:
Training Guide
Activity: Resolve Patient Sample Order with Exceptions Notes
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 .
the activity.
Resources:
Training Guide
Notes Activity (Optional): Run Multiple Patient Sample Orders
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.
the activity.
Resources:
Training Guide
Module 8: Patient Sample Notes
Orders
Review
Guide.
1. Samples resulting in an error instead of a result can be rerun

from what 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:

I. Host computer download
II. Host order query
III. Auto retest (Patient samples)
a) I only
b) II and III
c) I and II
d) I, II and III
4. What status allows you to delete an order?

Notes
a) Status of pending
b) Status of scheduled
c) Status of 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
Module 9: Basic Sample Progression
Notes
Module 9: Basic Sample
Progression
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 c16000 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
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.
• The c16000 uses an optical measurement process to obtain

absorbance readings, and then converts them to
assay-specific analyte concentration units or qualitative
interpretations.
• 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 c16000 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

Notes
calculate the assay results.
Assay Processing - Sample Progression

The movement of the reaction carousel, the timing of these
movements, and the position of the components allow
each reaction activity to occur at a specified time and
location. During processing, the reaction carousel rotates
counter-clockwise approximately 1/4 turn every 4.5
seconds to position the cuvettes at each location. Each
rotation includes 41 cuvette positions on the c8000
processing module or 41 cuvette pair positions on the
c16000 processing module. As each rotation occurs the
cuvettes pass the photometric position, where the lamp is
located, and the absorbance is measured in each cuvette.
There are assay processing protocols for one reagent, two
reagents, dilution, pretreatment and ICT.
ICT Fluidics
• The ICT Module is patented component used by Abbott for
indirect potentiometric measurement of electrolytes Na, K
and Cl. This module has a warranty of 60,000
determinations (20,000 samples). It requires no special
maintenance.
ICT reference solution and sample delivery/processing
• ICT Reference Solution and ICT samples are delivered to

the ICT module where measurement takes place.
• During processing, the following events occur:

Notes
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.
Demonstration: Sample Progression

Notes
• Below are some of the basic steps in the sample
progression for all assay protocol types on the c16000.
 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
take absorbance readings.
 The cuvette washer removes the reaction mixture to
waste then cleans, aspirates and dries the cuvette.
 Review concept of paired cuvettes on the C16000.
• Remind participants that they saw an animated visual of

the process in the c16000 Instrument Overview elearning
course.
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."
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
Module 9: Basic Sample Notes
Progressions
Review
Guide.
1. ICT sample processing uses all of the following EXCEPT….

a) An ICT module
b) ICT Reference Solution
c) c16000 Sample Probe
d) R2 reagent probe
2. 2.Assay sample progressions, (for all assays), include all of

the following EXCEPT….
a) c16000 Sample Probe
b) R1 Reagent Probe
c) Cuvettes
d) R2 Reagent Probe
Module 10: QC Analysis
\
Notes
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 c16000. 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
Notes
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® c16000 Chemistry

Customer Training Guide, Module 10 for further information.
Resources
• ARCHITECT System Operations Manual
Activity: Using KM for troubleshooting
Purpose: To be proficient in using KM to search instrument
related troubleshooting information.
Action: Perform a free text search for 'Lithium QC out of
range.”
have concerning this activity.
Resources:
Notes
Review
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?
Module 11: Additional Maintenance
\
Notes
Module 11: Additional
Maintenance
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. This module covers the
purpose of each and how to follow the procedures.
Module Topic:
• Weekly, Monthly, and Quarterly Maintenance
• Perform Maintenance Procedures
• Maintenance Log
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

Guide
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.
have.
Resources: ARCHITECT Systems Operations Manual, section
9
Demonstration: Monthly Maintenance

 Checking dispense components for bubbles, tight
screws and non-discolored tubing.
 Cleaning cuvette washer nozzles
 Checking syringes and valves for leaks
 Cleaning ICT drain tip
Activity - Monthly Maintenance
Purpose: To become proficient at performing Monthly

Notes Maintenance procedures.
Actions: Have participants complete all monthly
maintenance activities.
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
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
 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
the activity.
Resources
Training Guide
ARCHITECT System Operations Manual, section 9, page 27
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
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..
the activity.
Resources
Training Guide
Demonstration: Maintenance Log in Log-IC Troubleshooting
Purpose: Introduce the use of Log-IC tool.

Resources:
Additional Training Resources:
 Maintenance log from Log-IC example file
 Refer to the appendix for an example of the Log-IC
maintenance log.
Notes
Module 11: Additional
Maintenance
Review
Guide.
1. Which of the following is part of Monthly Maintenance for

the c16000?
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?
Module 12: Common Errors and Troubleshooting
Module 12: Common

\
Notes
Errors and
Troubleshooting
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
• Diagnostic Procedures
• Common Errors and Troubleshooting
• FORT Troubleshooting Approach
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 learners to go through

FORT troubleshooting steps. Identify the FORT category and
then system components to assist in troubleshooting assay
related issues:
 One reagents vs. two reagents
 STEP Troubleshooting Model
 eSolutions
 KMS
 Service and Support Manuals
 TSB/ISA database
 STEP = Stop, Think, Evaluate, Proceed
Resources
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.
Errors on the c16000

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:
Common Errors and Troubleshooting
• Discuss the list of common errors on ARCHITECT c16000

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).
• Discuss the ability to move reagents from one line to

another for troubleshooting purposes.
Activity: Review Common Error Codes Notes
Purpose: To become proficient at identifying common

errors and determining possible resolutions.
Actions: Perform the activity in Module 8 in the Abbott
Discussion: Discuss common errors that occur on the
c16000 and the possible causes/resolutions to address
those issues.
Resources:
Training Guide
Purpose: To become proficient at researching common
Activity: Perform a Common Troubleshooting Task
error codes.
Actions: If time allows, show participants one or two of the
troubleshooting steps for common errors, such as:
 Checking pipettor probe screws
 Tighten pump and syringe connections
 Clean the barcode reader
 Check the water quality
the activity.
Resources:
Training Guide
Activity: KM Error Code Search
Purposes: To become proficient at searching for error

codes in KM.
Actions: Search KM for error code 0218.
the activity.
Resources:

Notes Training Guide
Module 12: Common Errors and Notes
Troubleshooting
Review
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
Module 13: Basic Component Replacement
Module 13: Basic Notes
Component
Replacement
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 c16000 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
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
Resources:
Notes
 KM FAQ section, R&R Video Procedures/Select c16000
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® c16000 Chemistry
Customer Training Guide, near the end of Module 13.
the activity.
Resources
Training Guide
Notes Module 13: Basic Component

Replacement
Review
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?
Module 14: Configuring Options
\
Notes
Module 14: Configuring
Options
Objectives: • View and edit configuration settings for

system, assays and quality control.
Module Description
This module briefly shows ways to customize the ARCHITECT

c16000 for your needs through configuration settings.
Module Topics
• System Configuration Settings
• Assay Configuration Settings
• QC-Cal Configuration Settings
Notes
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® c16000 Chemistry Customer Training Guide for
further information.
Resources
Demonstration: System Configuration
System Configuration Settings
• Log in as ADMIN or higher for system configuration.
• Sample Ordering
Notes
 Configure settings for:
 Batch ordering
 Calibration ordering options
 Control ordering options
 Average tests per sample
 Refer to Module 14 Configuration Options, in the
Customer Training Guide for further information.
• 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
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.
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
Notes
 Age and gender specific ranges
 Normal and extreme ranges
 Edit or delete ranges
 Linearity range
 Interpretation
 Name
 Range
 Requirement to view result
New Assay
• 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
Notes
 Retest assays
 Retest dilution
Assay Display Order
• 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

Notes
the activity.
Resources:
ARCHITECT System Operations Manual
QC-Cal Configuration Settings

• 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
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

Notes
Multiconstituent bar code SID
• MCC Barcode Options:
 ID
 Control
 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.
Activity: Configure QC
Purpose: To become proficient at changing configuration

settings
Actions: Perform Activity 1: Module 14, Abbott ARCHITECT®

c16000 Chemistry Customer Training Guide, near the end
of the module.

the activity.
Resources:
Activity: HIL Activity Notes
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

Notes Abbott Link)
a) Choose SYSTEM Navigation Key – Choose Diagnostics
Menu
b) Select the SCC (5)
c) Arrow down
d) Choose Utilities
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.
the activity.
Resources:
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 learners 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
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® c16000 Chemistry Customer
Training Guide.
the activity.
Resources:
Notes
Review
Guide.
7. 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
8. Certain flags are printed on the sample and patient reports

whether the report flagging feature is turned on or off.
a) True
b) False
9. 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.
10. What status 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
Module 15: System Utilities
\
Notes
Module 15: System
Utilities
Objectives: • View previously installed software updates
• Backup the system software
Module Description
This module reviews some of the system tools for keeping the
ARCHITECT c16000 software up-to-date and backed up.
Module Topics
 System Logs
 Software Backup
Notes
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
 Discuss the two steps needed to perform a complete
system backup.
Activity: Backup Software Notes
Purpose: To become proficient at performing a software

backup.
Actions: Perform a software backup.
the activity.
Resources:
Notes
Review
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
Module 16: Abbott Tools and Resources
\
Notes
Module 16: Abbott Tools
and Resources
Objectives: • Open and view Abbott Mail
• Describe the function of AbbottLink
• Describe some of the benefits of Premium

Package
Module Description
The ARCHITECT c16000 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
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
Activity: Check Abbott Email
Purpose: To become proficient at using Abbott Email

Actions: Check Abbott mail.
the activity.
Resources:
 ARCHITECT System Operations Manual, What’s New
section
Module 16: Abbott Tools and Notes
Resources
Review
Guide.
1. Name some features of the Premium Benefits Package.
2. List 4 functions of AbbottLink.
Final Assessment Activities
Notes
Final Assessment
Activities
Objectives: • Assess ARCHITECT c16000 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.
Notes
Complete Troubleshooting Practical

Activities
• Demonstrate proficiency in all of the major areas of the
instrument by successfully completing the operational and
troubleshooting activities.
Troubleshooting Practicals(3 Hours)

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
Notes
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.
Appendix
Figure 1:Primary components of the c16000 System
1. Processing Module
2. RSH - Robotic Sample Handler
3. SCC - System Control Center
Global ARCHITECT c16000 Application Training Program| Global Service Training| 80000618-101 Appendix-1
System Components Overview
Figure 2:c16000 Processing Center Components
Answer Key
1 Sample Hardware Components
2 Reagent Hardware Components
3 Reaction Carousel Components
Appendix-2 Global ARCHITECT c16000 Application Training Program | Global Service Training| 80000618-101
Figure 3:c16000 Sample Hardware Components
Answer Key
1 Sample carousel
2 Indicator lights
3 Sample bar code reader
4 Sample pipettor
5 Sample probe wash cup
Figure 4:c16000 Process Center
Identify the components by writing their names next to the corresponding letter.
Answer Key
1 Reagent Supply Center 1
2 Reagent Supply Center 2
3 Reagent pipettors R1A and R1B
and wash cups
4 Reagent pipettors R2A and R2B
and wash cups
5 Reagent bar code readers: Read
2D
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
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)
Maintenance Log Screen
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.
Refer to cSystems Comparison Table:

http://adcollab.oneabbott.com/add/gss/ARCHITECT/Product%20Family%20Documents/80000268‐101.pd
f
cSystems 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.
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.
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
• When Ac1 < A Ac2
• X = F2 × (A - Ac1) + C1
• X = F3 × (A - Ac2) + C2
• X = F4 × (A - Ac3) + C3
• X = F5 × (A - Ac4) + C4
• When Ac5 < A
• X = F6 × (A - Ac5) + C5
• 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.
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:
Where:
 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.
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(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
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:
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

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
 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
Figure: 11. Electrode (mV) response curve during calibration
Where:
 CL, CH = Concentration of the Low and High Calibrators
 ΔEL, ΔEH = Difference in potential of each electrode between the ICT
Reference Solution and the calibrator
 Ci = Concentration of the specific ion of interest
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
• 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
ICT Index
An Index solution can be used to compensate for differences between ICT
modules, day-to-day instrument variations, and matrix differences between
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.
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.
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

C16000 App Trainning

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Global ARCHITECT c16000

Global ARCHITECT c16000 Application Training Program | Global Service Training|80000618-101

Copyright 2015, Abbott Laboratories, Abbott Park, Illinois.

The ARCHITECT c16000 Application Training Program is designed to provide Global

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

• Explain the basic process of the ARCHITECT c16000.

• Operate the instrument to run patient sample orders.

• Complete maintenance activities to keep the instrument in good working

• Use support tools that includes Active Sense Technology.

Prerequisite activities that must be completed are:

 Service Tools Overview

The Global ARCHITECT c16000 Application Training Class will be presented by

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

Warnings are inserted throughout the ARCHITECT System Operations Manual to

ARCHITECT c16000 Safety Hazard Information

Electrostatic Discharge (ESD)

Safety Icons and Hazard Symbols

• If the possibility of pressurized liquid exists, or if significant force is needed to

How to Use This Guide

Activity: Name of Activity

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

Demonstrate: Concept or Process Name

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

Getting Started GS-1

Module 1: Overview of the ARCHITECT c16000 System 1-1

Module 2: System Statuses 2-1

Module 3: Consumables and Inventory Management 3-1

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

Module 5: Daily Maintenance 5-1

Module 6: Calibrations 6-1

Module 7: Quality Control 7-1

Module 8: Patient Sample Orders 8-1

Module 9: Basic Sample Progression 9-1

Module 10: QC Analysis 10-1

Module 11: Additional Maintenance 11-1

Module 12: Common Errors and Troubleshooting 12-1

Module 13: Basic Component Replacement 13-1

Module 14: Configuring Options 14-1

Module 15: System Utilities 15-1

Module 16: Abbott Tools and Resources 16-1

Final Assessment Activities 17-1

Estimated Time: [75 minutes]

Objectives: • Discuss the Overview of ARCHITECT c16000

• Demonstrate proficiency in using MyGSS

This module provides an overview of ARCHITECT c16000

• ARCHITECT c16000 Application Training Program overview

• Use of service tools

ARCHITECT c16000 Application Training

• Review class agenda

• Define class expectations

Use Service Tools

Purpose: To demonstrate the use of Knowledge

Activity: AbbottLink Activity Notes

Purpose: To perform support related AbbottLink tasks.

Activity: Locating and Navigating in MyGSS

Purpose: To become proficient at locating information in

3. Where do you find the Knowledge Management System

4. Where do you find ARCHITECT Assay information?

5. The Knowledge Management System is:

Module 1: Overview of Notes

the ARCHITECT c16000

Objectives: • Explain the basic process of the ARCHITECT

• Identify major external and internal system