Application Guide

Global Alinity ci-series
Application Training
Program
Participant Guide
Overview
Table of Contents
Modules
Alinity ci-series Global Application Training | Internal Use Only|80002250 -101

Training History
Training History
REVISION STATUS
Document Control Revision Date Content or Pages Revised, Added, or
Number Deleted
80002250-101 Mar, 2019
ii Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Training History
Proprietary Statement
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
(Help), Operations Manual addendum, or Product Information Letter takes precedence.
Disclaimers
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 herein. The
Information is presented "AS IS" without warranties, either express or implied, 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.
Alinity is a trademark of Abbott Laboratories in various jurisdictions. All other trademarks are property of
their respective owners.
No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any
means without the prior written permission.
The information, documents and related graphics published herein (the "Information") are the sole
property of Abbott Laboratories.
iii Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Training History
Permission to use the Information is granted, provided that:
• the copyright notice appears on all copies;
• use of the Information is for operation of ABBOTT products by Abbott Laboratories trained personnel
or informational use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
This guide was developed and produced by Global Service Training, Dallas, TX.
Copyright 2019, Abbott Laboratories, Abbott Park, Illinois.
iv Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Training Overview
Training Overview
The purpose of this course is to provide the knowledge, skills, and systematic approach necessary to
perform basic operations on the Alinity ci-series.
This training guide is designed for use in conjunction with your Alinity ci-series systems and Alinity
ci-series Operations Manual (Help) located on the system.
Goals
Upon completion of the training program you will be able to:

• Describe the major external and internal system components.
• Use the system software.
• Order and run specimens.
• Order and run assay calibrations and quality control samples.
• Complete maintenance activities.
• Troubleshoot common errors and issues.
• Remove and replace common components due to normal wear during operation.
• Use Active Sense Technology Tools (AST) to support proactive service approach.
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 basic operations. 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
 Alinity c-series Overview CBT
 Alinity i-series Overview CBT
 Abbottlink CBT
 Fundamentals of Assay Troubleshooting CBT
 Alinity ci-series System Software Overview CBT
v Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Materials
 Service Tools Overview

 Immunoassay Backgrounder CBT
 Basic Clinical Chemistry CBT
 Active Sense Technologies (AST) How-to-Skills
2. Pre-Work Activities
 Confirm access to AbbottLink, LOG-Q, and MyGSS.
 Obtain access to FSE/CSC log-on. Facilitator will send instructions.
 Participants need to bring a USB that is greater than 2GB and is not software encrypted with
password protection to class.
Note: A 2-day AbbottLink Utilization Training Program and a 2-day Advanced Troubleshooting Training
Program (AbbottLink and LOG-ICAL) 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.USB drives will be used in class.
Materials
The Global Alinity ci-series Application Training Class will be presented by facilitators using the
following materials:
 Alinity ci-series Operations Manual
 Alinity ci-series Service Documentation
 Alinity ci-series Customer Training Guide
Note: 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.
vi Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Safety Hazards
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
The Alinity ci-series systems have 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 Alinity ci-series 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.
Alinity ci-series Systems Safety Hazard Information
• When working with the Alinity ci-series, there are other safety precautions that must be adhered to
for consistent and accurate operation. The following activities might involve the presence of
hazardous materials or other conditions:
 Handling samples, reagents, calibrators, and controls.

 Cleaning spills.
 Handling and disposing of waste.
 Moving the system.
 Performing maintenance procedures.
 Performing decontamination procedures.
 Performing component replacement procedures.
 For more information on precautions and hazards, refer to the Alinity ci-series Operations
Manual (Help).
• 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.
vii Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
How to Use This Guide
Black Text
• The black text will appear in both Facilitator Guide and Participant Guide.
Resources
• Resources in black will appear in both the Facilitator and Participant Guides.
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.
Purple Text
• Text that appears in purple is intended for Remote Support 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.
Demonstration: Example
• Demos will be conducted by the facilitator so all participants can see

a given process in action.
viii Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Special Tables for Notes and References
Note: Will contain special information not contained within the

text.
Reference: This table will contain references to published materi-

als or online manuals.
 Knowledge Management: Specific references to KM articles will

appear in this table.
Procedure Map Reference: Bread crumbs leading to procedure

information will display in this table.
Online Operations Manual (Help): Specific references to the

Online Operations Manual (Help) will display in this table.
ix Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Contents
Getting Started........................................................................................................GS-1
Module 1: Instrument Overview .....................................................................1-1
Module 2: System Statuses .............................................................................2-1
Module 3: Basic Sample Processing ..............................................................3-1
Module 4: Consumables and Inventory Management................................4-1
Module 5: Reagent and Sample Manager (RSM) ........................................5-1
Module 6: Daily Maintenance ........................................................................6-1
Module 7: Calibrations ....................................................................................7-1
Alinity ci-series Global Application Training | Internal Use Only |80002250-101 TOC-2
Contents
Module 8: Control Orders................................................................................8-1
Module 9: Patient Sample Orders ..................................................................9-1
Module 10: Additional Maintenance...........................................................10-1
Module 11: Common Errors and Troubleshooting ......................................11-1
Module 12: Basic Component Replacement .............................................12-1
Module 13: Configuration Options ................................................................13-1
Module 14: Utilities .........................................................................................14-1
Module 15: Abbott Mail .................................................................................15-1
Final Assessment Activities............................................................................16-1
Appendix ................................................................................................................ 17-1
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Getting Started
Getting Started
Estimated Time: [40 minutes]
Objectives: • Review agenda and set class expectations

• Check pre-training completion
• Reinforce use of Active Sense Technology
Module Topics
This module provides course introduction, defines class expectations, reinforces concepts of Active
Sense Technologies, and reviews pre-training modules.
• Align to class expectations
• Use service tools
Setting Class Expectations

• This training class contains significant hands-on activities. Participants are expected to perform
procedures on instruments and complete activities using appropriate serve tools.
• Define class expectations
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Getting Started
 Confirm completion of pre-training requirements by all participants; set completion

expectation for individuals who have not finished required pre-learning
• Safety Concerns
 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.
Using Service Tools

Application Specialist Activity: Using the Knowledge Management Tool
Purpose: To demonstrate the use of Knowledge Management searches to find troubleshooting

information.
Actions: Search KM articles as directed by instructor.
Discussions: Check understanding of KM tool and key features
 Highlight that Alinity information will not be put into e-solutions
 Review that KM has two options for article searches. Blended search uses the KM software to
deliver a series of questions which guides the user to the correct solution based on the
answers provided. Expert search is an open search where the user chooses the main
category, then follows the details to select the relevant article.
Getting Started
Application Specialist Activity: AbbottLink Activity
Purpose: To perform support related AbbottLink tasks.

Action: Log in to AbbottLink using your ID and password.
 Create a watch list using the serial number provided by the facilitator.
 Retrieve a message history log.
 View historical data and find Instrument Notification Texts for the last week.
 Retrieve a Troubleshooting Package for Alinity as instructed.
 Retrieve a calibration log, then open and review data.
 Retrieve a result log and save to a folder.
Discussion: Briefly identify the following:
 Benefits of the watch list
Application Specialist Activity: Locating and Navigating MyGSS
Purpose: To become familiar with the location of the training checklist.

Actions: Locate the training checklist from MyGSS.
Discussion: Discuss any questions regarding locating the training checklist in MyGSS.
Resources: MyGSS
Application Specialist Activity: Locating Alinity Operations Manuals
Purpose: To become familiar with different types of Alinity ci-series Operations Manuals.
Actions: Locate the Alinity Operations Manuals from MyGSS.
Discussion: Discuss questions regarding locating the Operations Manuals.
Resources: MyGSS
Getting Started
Application Specialist Activity: Locating International Package Inserts via

GSS Web
Purpose: To become familiar with the link to international package inserts.

Actions: Locate link to international package inserts
Discussion: Discuss any questions regarding locating the insert link via MyGSS
Resources: MyGSS > Product Family >Architect (or Alinity) > Assay Information Scroll to the
bottom of the screen and in small letters it will have a link to the International Technical Library
Application Specialist Activity: Adding notes to PDF files on an iPad
Purpose: To become familiar with opening PDF documents and adding notes to PDF documents
on an iPad
Actions: Follow instructions in the Adding Annotations on an iPad
reference document as directed by facilitator
Discussion: Discuss any questions regarding adding annotations on a PDF document on an iPad.
Resources: Adding Annotations on an iPad document
Getting Started
Application Specialist Activity: Service Documentation on MyGSS
Purpose: To become familiar with service documentation on the GSS Website.

Actions: Follow instructions to open service documentation from the GSS Website as directed.
Discussion: Discuss any questions regarding service documentation
Application Specialist Activity: Alinity c-series and i-series Photo Navigator
Purpose: To become familiar with location of the photo navigators on the GSS Website.
Actions: Follow instructions to locate the photo navigators from the GSS Website as directed.
Discussion: Discuss any questions regarding the photo navigators.
Getting Started
Application Specialist Activity: Net Promoter Score (NPS)
Purpose: To become familiar with the concept of NPS.

Actions: Discuss NPS, what it means, how it is calculated, and how Abbott employees can affect
NPS.
Review the following concepts.
 NPS = Net Promoter Score, which is a way we help to measure customer loyalty.
 Customer loyalty has an attitude component (I feel good about this product) and a behavior
component (I’ll keep buying this product). Customer loyalty is a key component of Abbott’s
organizational vision.
 The NPS survey asks one question, “On a scale of 1-10, how likely are you to recommend
Abbott to a colleague or friend?
 0-6= Very Unlikely = Detractors
 7-8=Neutral=Passives
 9-10= Extremely Likely = Promoters.
A follow-up question asks the customer why they responded the way they did to gather
actionable data.
 The Net Promoter Score (NPS) is calculated by taking the percentage of customers who are
Promoters and subtracting the percentage of customers who are Detractors. Passives and
detractors are all seen as customers that are not loyal to Abbott and could switch to another
vendor.
 Once a customer reports an issue through the NPS system, a manager follows up with the
customer regarding the issue within 72 hours. We aim to close all issues and report back to the
customer within 20 business days.
 Creating the environment for happy customers leads to long-term, sustainable growth. Every
employee at Abbott is responsible for treating both internal and external customers in a way
to drive them towards being promoters.
Discussion: Discuss any questions regarding the NPS.
Getting Started
Remote Support Activity: Instrument Screen Sharing / Instant Virtual Presence (ISS/IVP) Session
Purpose: To become familiar with the concept of ISS/IVP.

Actions: Discuss ISS/IVP.
 Instrument screen sharing allows the user to gain access to the customer screen on their
instrument to be able to assist them with functions in real time.
 The user must complete ADD_GLOBAL_1017_ALINKIVP_DOC training in SumTotal and must
set-up their computer prior to having access to the ISS program
 Instructions for How to Train on ISS and how to start an ISS session are available on the GSS
Website by going to Product Family > Abbottlink > Training
Discussion: Discuss any questions regarding ISS/IVP.
Module 1: Instrument Overview
Objectives • Identify the primary components of the system to support

application tasks
• Identify the primary components of the system
• Describe the features of the system control module (SCM)
• List the functions of the reagent and sample manager (RSM)
• Identify major external and internal system hardware
components of the Alinity c and Alinity i processing modules
• Identify the main elements of the User Interface screen,
Home screen and Menu bar
• Log on to the System
• Lock the User Interface
• Access and navigate the online Operations Manual and
Procedure Map
Module Topics
Familiarizing yourself with the instrument is essential to ensuring that it performs appropriately.
In this module, you will explore:
• Primary components
• System hardware
• System software
1-1 Alinity ci-series Global Application Training | Internal Use Only| 80002250 -101
Online Operations Manual (Help):Refer to the Alinity

ci-series Operations Manual for more information.
The sections relevant to the information presented in
this training module are:
• Section 1 Use or Function subsections; Alinity
ci-series hardware overview and Alinity system
software overview
• Section 5 Operating Instructions subsections; Log
On screen and Home screen documentation
Introduction
With the scalable design of the Alinity ci-series family of analyzers, multiple processing modules can
perform all sample-processing activities and can be physically joined to form one workstation or
system. The processing modules determine the system configuration.
An Alinity ci-series can be configured as:
• One stand-alone chemistry system.

• One stand-alone immunoassay system.
• A multimodule system that is a fully automated clinical chemistry assay and immunoassay
system.
Multimodule
System
Stand-alone
System
Note: A multimodule system includes multiple

processing modules in different combinations
of chemistry and immunoassay processing
modules.
Primary Components
View Primary Components
Follow along as your facilitator shows you the Primary components on the
Alinity ci-series and reviews the major functions listed in this training
module.
A multimodule system includes multiple processing modules in different combinations of

chemistry and immunoassay processing modules. Regardless of the type of modular design -
one module or multiple modules - all systems have three primary components in common. They
are the:
 System Control Module (SCM)
 Reagent and Sample Manager (RSM)
 Processing Module (PM)
The facilitator will identify and describe the common primary components of the Alinity ci-series,
including the:
System Control Module (SCM)

Provides a common user interface among all Alinity
products.
Reagent and Sample Manager (RSM)

Transports reagents, samples, calibrators, and controls
through the Alinity ci-series. Each system has one primary
RSM regardless of the type and number of processing
modules.
Processing Module
Performs all sample-processing activities from sample
aspiration to final result reporting. The type and number of
processing modules determine the system configuration.
Online Operations Manual (Help): Use or function > Alinity ci-series

hardware overview > Primary components of an Alinity ci-series

This section will provide you with basic knowledge about the hardware components of the Alinity
ci-series.
The System Control Module (SCM) contains the following items:
 The User Interface (UI) computer that provides the software interface to the Alinity ci-series
and provides an interface to a host or middleware computer.
 Hardware and software that operate the RSM.
 The power supply that operates the User Interface (UI) computer and the RSM.
The front SCM cover is monitored by a sensor. If the cover is opened when the instrument status
of the RSM is Initializing or Running, the status transitions to Stopped.
 On an integrated system, the SCM is always located in the middle. The Alinity c or i install ISAs
show platform placement. Example:
a) 2 and 4 module configurations - SCM in middle;
b) 3 modules - 2 processing modules to the left and 1 module to the right (allows placement
preparation in a 4 module configuration)

hardware overview > Primary components of an Alinity ci-series >
• The System Control Module (SCM, front view) exterior is composed of the:
 Adjustable monitor: Displays the user interface of the Alinity ci-series and accepts on-screen
selections from the operator.
 Front SCM cover: Provides access to the RSM transport. The front SCM cover is monitored by a
sensor. If the cover is opened when the instrument status of the RSM is Initializing or Running,
the status transitions to Stopped.
 SCM shelf: Provides a small shelf for the operator and provides access to remove the
barcode scanner.
 Bar code scanner: Provides a means to scan sample bar codes and supply bar codes.
 SCM front door: Provides access to the user interface computer and SCM procedure key.
 Procedure Keys will be covered more in another module.
• The System Control Module (SCM, rear view) exterior is composed of the:
 Rear SCM cover: Provides access to the user interface computer power strip.
 Rear SCM upper access panel: Provide access to the Ethernet switch.
 Network connectors: Provide connections for external devices, such as the host interface
and Abbottlink
 SCM main power breaker: Powers on and powers off the SCM power supply
 Rear SCM lower access panel: Provides access to the power supply and RSM electronics.
System Control Module (SCM) hardware components

The SCM supplies power to the SCM and RSM.
.SCM Hardware Components

Identifier Component Description
1. Bar code Scanner Scans sample bar codes and supply bar codes. When the SCM shelf is
accessed, the bar code scanner can be removed from the holder and
can be used as a hand-held scanner
2. Uninterrupted power Provides a temporary, continuous flow of power to the user interface (UI)
supply (UPS) computer during a power failure, which helps the operator to save data
as necessary and to perform a controlled shutdown procedure (Optional
component)
3. RSM X motor Moves the RSM transport from position to position and from module to
module
4. Firewall Provides data protection between the UI computer and the
supporting communications network
5. UI Power Switch Distributes AC power to the UI computer, the adjustable monitor,
and the Ethernet switch
6. RSM embedded Provides the software control for the RSM
computer
7. Ethernet switch Joins communication lines and facilitates the electronic transfer of
information among the UI computer and the processing module
embedded computer and the RSM embedded computer
8. Network Provides connections for external devices, such as host interface
connectors and AbbottLink
9. SCM power supply Provides AC power to the UI power strip and DC power to the RSM
hardware
10. UI computer Provides the software interface to the Alinity ci-series and provides
an interface to a host or middleware computer
11. Water inlet Provides a common area for the entrance and distribution of water
for all processing modules in a system
12. Waste manifold Provides a common waste outlet area for all processing modules in
a system

System Control Module (SCM) > System Control Module (SCM)
hardware components
Network Connectors
Network connectors provide connections from the user interface computer, through the firewall, to
the wide area network (WAN) and to other external devices, such as the host interface, a
middleware computer, and Alinity PRO.
Adjust the monitor position

Adjust the height and angle of the monitor using pivot points on the monitor support arm.
Monitor Pivot Points Adjust the monitor so that it is an Tilt the Monitor
arm's length from the face
Move the monitor to the right side or the left side of the instrument as needed. The ideal position
depends on the instrument configuration and the location of the operator.
Use the attached handles to rotate the monitor to the rear of the instrument when required.
Procedure Map Reference: Setup > Adjust the monitor position >
Adjust the monitor position.
Distance Alert
The distance alert is an optional component on the workstation that is used to identify instrument
conditions that require an operator response to maintain the optimal workflow.
 There is an order of color illumination if there are multiple conditions present.
 The distance alert can be off for the following conditions:
 The distance alert is disabled.
 The user interface computer is shut down.
 The instrument status of one or more processing modules in the workstation is not Running,
Processing, or Pausing.
The optional distance alert illuminates one of three colors (red, amber, or green) based on the status
of the workstation.
Color Meaning(s)
Red (Blinking) • The instrument status of one or more processing

modules in the workstation transitions from
Running or Processing to Stopped or Offline
without an operator request to transition the
status.
• A critical alert message is generated and is
displayed on the user interface
Red The instrument status of one or more processing
modules in the workstation is Running, Processing, or
Pausing, and one of the following conditions is
present:
• A red badge is displayed on any icon on the

menu bar
• An alert message that has not been cleared is
present in the Alert Center
Amber The instrument status of one or more processing
modules in the workstation is Running, Processing, or
Pausing, and one of the following conditions is
present:
• An amber badge is displayed on any icon on the

menu bar except the Results icon
• A notification message that has not been cleared
is present in the Alert Center
Green (Blinking) The instrument status of one or more processing
modules, but not all modules, in the workstation is
Running or Processing.
Green The instrument status of all processing modules in the
workstation is Running or Processing.
Distance alert off When one of the multiple conditions is present, the
following situations occur:
• The distance alert is disabled.

• The user interface computer is shut down
• The instrument status of one or more processing
modules in the workstation is not Running,
Processing, or Pausing.
Activity 1: Adjust the monitor position
Purpose: To become proficient at adjusting the monitor.

Actions: Perform the steps to adjust the monitor for proper viewing.
Discussions: Discuss any questions or issues that may arise from the activity.

System Control Module (SCM) > Adjust the monitor position
Procedure Map Reference: Setup > Adjust the monitor position >
Adjust the monitor position
Activity 2: Identify primary components
Purpose: To become proficient at identifying the primary components of the Alinity ci-series.
Actions: List the three primary components of the Alinity ci-series.
1______________________________________________________________
2______________________________________________________________
3_______________________________________________________________

hardware overview > Primary components of an Alinity ci-series
Activity 3: Identify System Control Module (SCM) hardware components
Purpose: To become proficient at identifying the System Control Module (SCM) hardware
components.
Actions: Using the activity in the appendix, label the components of the SCM.

System Control Module (SCM) > System Control Module (SCM)
hardware components
Discussions: Discuss any questions or issues that may arise from the activity
Activity 4: Locate components
Purpose: To become proficient at locate system components.

Actions: Locate the following components:
 UI Computer
 Bar code
 Scanner Network Connectors

Knowledge Check: System Control Module (SCM) hardware

components
1. True or False? When adjusting the monitor, you should locate the monitor at a comfortable eye
level.
Answer:
2. Which module supplies power to the RSM?

a) Processing Module
b) System Control Module (SCM)
Answer:
Processing Module
Unless otherwise indicated, processing module is used generically throughout this manual to refer to
both types of modules.
Alinity c
The Alinity c processing module is a fully automated chemistry analyzer allowing random and
continuous access, as well as priority and automated retest processing using photometric and
potentiometric detection technology.
The Alinity c processing module uses photometric detection technology to measure sample
absorbance for the quantification of analyte concentration and uses potentiometric detection
technology to measure the electrical potential in a sample.
In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to
measure potentiometric assays (electrolytes).
Alinity i
The Alinity i processing module is a fully automated immunoassay analyzer allowing random and
continuous access, as well as priority and automated retest processing using chemiluminescent
microparticle immunoassay (CMIA) technology.
CMIA technology is used to determine the presence of antigens, antibodies, and analytes in
samples.
System Hardware - Alinity c-series

Processing Module - Alinity c-series
• Processing modules perform all sample-processing activities from aspiration to final read.
• The Alinity c-series processes a maximum of 1350 photometric and potentiometric tests per hour
and has 70 positions in the reagent carousel at a controlled temperature.
• The facilitator will identify and describe the components of the Alinity c-series, including the:
 Processing module exterior
 Processing center
 Supply and pump center
 Reagent supply center
Processing Module Exterior

• The Alinity c-series processing module exterior (front view) is composed of the following:
 Front processing center cover: Provides access to the components that perform
assay-processing activities.
Note: The front processing center cover is monitored by two sen-

sors. If the cover is opened during Initializing status, Running status,
or Processing status, the Reagent and Sample Manager and the
processing module transition to Stopped status.
 Bulk solution door: Provides access to the bulk solution storage area and the pump center.
 Front electronics door: Provides access to the processing module electronics and the
procedure lock.
• The Alinity c-series processing module exterior (rear view) is composed of the following:
 Rear processing center cover: Provides access to the components that perform
Note: The rear processing center cover is monitored by a sensor. If

the cover is opened when the instrument status of the processing
module is Initializing, Running, or Processing, the status transitions to
Stopped.
 Rear access panel: Provides additional access to processing center components.
 Rear lower access panel: Provides access to the water management unit.
 Power supply panel: Provides access to the processing module power supply.
 Processing module main power breaker: Powers on and powers off the power supply.

Processing module > Processing Module (Alinity c)
Processing Center - Alinity c-series

The Alinity c-series processing center is composed of the following:
 Pipetting hardware
 Reaction carousel hardware
Processing Center Interior Lights

Processing center interior lights are located on the top panel of the Alinity i and Alinity c. The
interior lights provide additional lighting when routine maintenance and system troubleshooting
is performed. With either the front processing center cover or the rear processing center covers
opened the interior lights can be turned on. The interior lights are turned on by pressing the
interior light button located on the front edge of the top panel, indicated by the light icon if
present.
The interior lights come on at a preset level of intensity. The light intensity may be adjusted
through any of eight levels by pressing and holding either the front light button or the rear light
button. When the light intensity reaches either the lower extreme or upper extreme the light
intensity cycle will reverse. A single press to either the front light button or the rear light button will
turn off the interior light. Closing both the front processing center cover and the rear processing
center cover of a processing module will turn off the interior light. The power is supplied to the
interior light by the system control module so the interior light will work with the processing
module power turned off.
Pipetting Hardware
Pipettors detect, aspirate, transfer, and dispense samples and reagents into cuvettes. These
pipettor assemblies include a fluid sense and a pressure-monitoring system to help identify
aspiration errors.
Three pipettors that have the following functions are located on the system:
1. The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into cuvettes. It also
transfers diluted samples from the cuvette that is used to make the dilution into the cuvette that
is used for the reaction.
2. The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses diluents, reagents, and
onboard solutions into cuvettes.
3. The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents and onboard
solutions into cuvettes.
Wash Cups
The Alinity c wash cups are active wash stations that use system water to clean the pipettors. The
system has five pipettor wash cups.
1. Sample probe wash cup (SW): Washes the fluid that remains from the probe exterior and interior
between samples to eliminate carryover.
2. Whole blood wash cup (WB): Washes the exterior of the sample probe before a whole blood
sample is dispensed into the cuvette.
3. Reagent 1 pipettor wash cup (R1W): Washes any fluid that remains from the probe exterior and
interior.
4. Reagent 2 pipettor wash cup (R2W): Washes any fluid that remains from the probe exterior and
interior.
5. Laboratory automation system wash cup (LASW): Washes the fluid that remains from the sample
probe exterior and interior after whole blood samples to eliminate carryover. This wash cup is
used only on systems that are connected to a laboratory automation system (LAS).
Sample Wash Solution Area
The sample wash solution area stores sample onboard wash solutions that are used for the
SmartWash function and maintenance procedures. The area provides space for two sample tubes
in a removable sample wash solution holder.

hardware overview > Processing modules > Processing module
(Alinity c)> Processing center (Alinity c)> Pipetting hardware (Alin-
ity c)
Reaction carousel hardware
The reaction carousel hardware components position the cuvettes for sample and reagent
dispense, mixing, photometric or potentiometric analysis, and cuvette washing.
The Reaction Carousel Hardware consists of the following:
1. Mixers: Mix sample with reagent

2. ICT unit: Measures potentiometric assays (sodium, potassium, and chloride) by using integrated
chip technology (ICT).
3. Lamp: Provides the light source for photometric measurement
4. ICT high-concentration waste area: Receives liquid waste from the ICT unit
5. Cuvette washer: Washes and dries the cuvettes.
6. Water bath overflow and waste area: Receives overflow from the water bath, excess water from
the sample pipettor, and liquid waste from the ICT Reference Solution cup
7. Cuvette segments: Hold the cuvettes in the reaction carousel.
Each cuvette segment contains 11 cuvettes. The Alinity c processing module contains 17
segments for a total of 187 cuvettes in the reaction carousel.
8. Reaction carousel: Positions the cuvettes for sample processing
The reaction carousel supports a variety of assay protocols and has 17 cuvette segments
surrounded by a 37°C water bath. The carousel rotates counterclockwise to position the
cuvettes.
9. High-concentration waste pump: Works with the cuvette washer to aspirate waste from the
cuvettes to the optional high-concentration waste bottle or the drain

hardware overview > Processing modules > Processing module
(Alinity c)> Processing center (Alinity c)> Reaction carousel hard-
ware (Alinity c)
Supply and Pump Center - Alinity c-series

• The supply and pump center is the onboard storage area for processing module pumps, bulk
solutions, and sample and reagent syringes and drives. The supply and pump center is
composed of:
1) Bulk solution storage area
2) Sample and reagent syringes area
3) Bulk solution reservoir area
4) Pump center
• Bulk solution storage area: Located on the bulk solution door, provides the onboard storage for
replacement bulk solution bottles. Bulk solutions from the replacement bottles fill onboard bulk
solution reservoirs. Each bottle has a unique keyed cap that locks into its appropriate key slot in a
bottle holder. The bulk solution storage area is composed of Alkaline Wash, Acid Wash, ICT
Reference Solution and Bottle release buttons for each bottle.
• Sample and reagent syringes area: Houses the sample and reagent syringes and drives. Each
drive supports a syringe that aspirates and dispenses samples, reagents, and onboard solutions.
• Bulk solution reservoir area: The bulk solution reservoir area provides the onboard storage for bulk
solutions in use during assay processing. When onboard bulk solution reservoirs are empty, bulk
solutions from replacement bottles on the bulk solution door fill the reservoirs without an
interruption in system operation.
• Pump center: Houses the processing module pumps. These pumps provide the pressure that is
needed to aspirate and dispense liquids into the appropriate components in the processing
center.
The pump center is composed of:

1) Wash solution pump: Delivers diluted Alkaline Wash and Acid Wash solutions to the cuvettes
during daily operation and maintenance procedures. The middle syringe of the Wash Solu-
tion Pump serves to deliver degassed water to the sixth nozzle of the cuvette washer to be
used for the blank read.
2) ICT Reference Solution pump: Uses the syringe on the left side of the pump to deliver ICT Ref-
erence Solution into the ICT Reference Solution cup. After the ICT Reference Solution is mea-
sured, the ICT Reference Solution pump uses the syringe on the right side of the pump to drain
the cup.
3) ICT aspiration pump: Uses the syringe on the right side of the pump to deliver samples or ICT
Reference Solution into the ICT module for measurement. After measurement is completed,
the ICT aspiration pump uses the syringe on the left side of the pump to aspirate waste from
the ICT high concentration waste area to the high-concentration waste tubing.
4) ICT aspiration valve: Controls the direction of liquid flow while the ICT aspiration pump oper-
ates.

Processing modules > Processing module (Alinity c) > Supply and
pump center (Alinity c)
Reagent supply center - Alinity c-series

• The reagent supply center provides cooled storage at a controlled temperature for up to 70
bar-coded reagent cartridges, onboard solutions, sample diluents, and frequently used
calibrators and controls. Cartridges and vial racks are loaded on the reagent and sample
manager (RSM) and are transferred to the reagent positioner by the RSM transport.
• The reagent supply center (Alinity c-series) is composed of the:
 Reagent carousel: Holds reagent cartridges and frequently used calibrators and controls. The
carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors. It also
rotates to position onboard vial racks for transfer to the sample positioner so that calibrators
and controls can be aspirated and dispensed.
 Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent
carousel or onto the loading area. When the reagent positioner is in the open position, the
cartridge or rack can be transferred from the RSM transport to the loading area. The reagent
positioner then closes to allow the reagent transport to pick up the cartridge. The reagent
positioner then opens to allow the cartridge or rack to be transferred into the reagent
carousel.
 Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto
the reagent positioner

Processing modules > Processing module (Alinity c) > Reagent sup-
ply center (Alinity c)

Processing modules > Processing module (Alinity i) > Reagent sup-
ply center (Alinity i)
Activity 1: Identify Alinity c-series processing module (front view) exterior

components
Purpose: To become proficient at identifying the Alinity c-series processing module front exterior
components.
Actions: Match the item with the definition.
Item Definition
___ A - Front processing 1. Provides access to bulk solution storage
center cover and pump center.
___ B - Bulk solution door 2. Provides access to the module

electronics.
___ C - Front electronics 3. Provides access to the components that

door perform assay processing activities.

Processing modules > Processing module Alinity c
Activity 2: Identify Alinity c-series processing module (rear view) exterior

components
Purpose: To become proficient at identifying the Alinity c-series processing module rear exterior
components.
Item Definition
___ A - Rear processing 1. Provides access to the water
center cover management unit.
___ B - Rear access panel 2. Provides additional access to processing

center components.
___ C - Rear lower access 3. Provides access to the components that

panel perform assay processing activities.
___ D - Power supply 4. Powers on and powers off the power

panel supply.
___ E - Processing module 5. Provides access to the processing module

main power breaker power supply.

Processing modules > Processing module Alinity c
Activity 3: Identify processing center Alinity c-series components
Purpose: To become proficient at identifying the Alinity c-series processing center components.
Actions: List the two categories of processing center (c-series) components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Processing modules > Processing module (Alinity c) > Processing
center (Alinity c)
Activity 4: Identify Alinity c-series supply and pump center hardware

components
Purpose: To become proficient at identifying supply and pump center hardware (Alinity c-series)
components.
Actions: List four categories of the supply and pump center hardware (c-series) components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 5: Identify Alinity c-series reagent supply center components
Purpose: To become proficient at identifying reagent supply center (Alinity c-series)

components.
Actions: List the three categories of reagent supply center (c-series) components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Processing modules > Processing module (Alinity c) > Reagent sup-
ply center (Alinity c)
Knowledge Check: System Hardware (Alinity c)

1. Select the methodologies used by the Alinity c-series.
a) Photometric
b) RIA
c) Potentiometric
d) FPIA
Answer:
2. True or False? The supply and pump center is the storage area for bulk solutions.
Answer:
3. True or False? The reagent supply center provides cooled, temperature-controlled storage for
reagent cartridges, maintenance solutions, and frequently used calibrators and controls.
Answer:
System Hardware - Alinity i-series

Processing modules perform all sample processing activities from aspiration to final read.
The Alinity i processing module processes a maximum of 200 chemiluminescent microparticle
immunoassay (CMIA) tests per hour and uses a maximum of 47 reagents in a reagent carousel at
a controlled temperature.
The facilitator will identify and describe the components of the Alinity i-series, including the:
 Processing module exterior
 Processing center
 Supply center
 Reagent supply center
Processing Module
The Alinity i-series processing module (front view) exterior is composed of the following doors and
covers:
1. Front processing center cover: Provides access to the components that perform
Note: The front processing center cover is monitored by two sen-

sors. If the cover is opened during Initializing status, Running status,
or Processing status, the Reagent and Sample Manager and the
processing module transition to Stopped status.
2. RV hopper cover: Provides access to the RV hopper to replenish reaction vessels.
3. Bulk solution door: Provides access to the bulk solution storage area and the RV waste storage
area.
4. Front electronics door: Provides access to the processing module electronics and embedded
computer, and the procedure lock.
The Alinity i-series processing module (rear view) exterior is composed of the following doors and
covers:
1. Rear processing center cover: Provides access to the components that perform
Note: The rear processing center cover is monitored by one

sensor. If the cover is opened when the instrument status of the
processing module is Initializing, Running, or Processing, the status
transitions to Stopped.
2. Rear access panel: Provides additional access to processing center components.
3. Rear electronics panel: Provides access to instrument electronics.
4. Processing module main power breaker: Powers on and powers off the power supply.
5. Rear fluidics panel: Provides access to pumps and syringes

Processing modules> Processing module(Alinity i)
Processing center - Alinity i-series

The processing center is the main activity area of the processing module.
Samples and reagents are dispensed and mixed in reaction vessels (RVs) in the process and
pretreatment paths.
The Alinity i-series processing center is composed of the:
• Processing Path
• Pretreatment Path
• Pipetting Hardware
• RV Loader

Processing modules > Processing module (Alinity i) > Processing
module (Alinity i) > Processing center (Alinity i)
Process path light cover

• The process path light cover on the process path prevents external light interference with the
diverter sensors and the optics. One of two configurations will be installed on the system.
Online Operations Manual (Help): Use or function> Alinity ci-series

hardware overview> Primary components of an Alinity ci-series
>Processing modules > Processing module (Alinity i) > Processing
center (Alinity i) > Processing path light cover (Alinity i)
Processing Path
The process path is a covered, circular path that provides incubation at a controlled temperature,
liquid aspiration, and wash points as necessary for assay processing. The process path advances
reaction vessels (RVs) every 18 seconds and positions them at the designated locations to process
the CMIA reaction. The process path has 46 RV positions.
1. Vortexers (VTXR1, VTXR2, and VTXPT): Mix the reaction mixture to suspend microparticles.
2. Diverters (LD, STD, and WZD): Move RVs in the processing module from one lane of the process
path to a different lane during assay processing.
 The load diverter (LD) directs RVs from the outside load lane to the middle incubation lane.
 The STAT diverter (STD) directs RVs from the middle incubation lane to the inner reaction lane
for STAT assay processing.
 The wash zone diverter (WZD) directs RVs to one of two lanes. One lane moves RVs through
the wash zone where a wash occurs. The other lane moves RVs to the wash zone bypass lane
where a wash does not occur.
3. Liquid waste arm: Removes the liquid from RVs.
4. Wash zone assemblies (WZ1 and WZ2): Dispense the wash buffer into RVs, and remove and
discard the unbound material from the RV reaction mixture.
5. RV access door (RVA): Provides access to one position on the reaction lane. Use this door only
for diagnostic purposes and confirm that it is closed during system operation.
6. Process path motor (PPM): Rotates the process path disk, which holds the RVs, and advances the
RVs from position to position.
7. Pre-Trigger and Trigger manifold (PTT): First dispenses Pre-Trigger Solution into RVs and then
dispenses Trigger Solution into RVs.
8. Optics: Measures the chemiluminescent emission from RVs and outputs the data that
corresponds to the quantity of emission detected.
9. RV unloader (RVU): Removes used RVs from the process path and discards them into the solid
waste container after assay processing is completed.

center (Alinity i) > Process path (Alinity i)
RV Wash Process
The wash zone assemblies (WZ1 and WZ2) dispense the wash buffer into reaction vessels (RVs), and
remove and discard the unbound analyte from the reaction mixture in the RVs.
Each wash zone has four positions where the following actions occur:
• At each position, a magnet attracts paramagnetic microparticles to the wall of the RV.
• At position 1, a dispense nozzle dispenses the wash buffer into the RV.
• At position 2 and position 3, a vacuum is applied to the wash zone probes as they move to the
bottom of RVs and aspirate the liquid from RVs. In addition, nozzles dispense the wash buffer into
RVs. Additional wash and aspiration cycles occur at these positions.
• At position 4, a wash zone probe aspirates liquid waste from the RV.
Pretreatment path
The pretreatment path is a covered, circular path that provides incubation at a controlled
temperature for pretreatment assay protocols. The pretreatment path advances reaction
vessels (RVs) in two lockstep durations. It advances RVs at 3 seconds, followed by a 15-second
lockstep for a total of two positions every 18 seconds. RVs are positioned at the designated
locations to process a pretreatment assay protocol. After the pretreatment assay protocol is
completed, the sample is transferred to the process path. The pretreatment path has 61 RV
positions.
The pretreatment path consists of the following parts:

 Pretreatment path motor (pPM): Rotates the pretreatment path disk, which holds the RVs, and
advances the RVs from position to position.
 Pretreatment vortexer (pVTX): Mixes the reaction mixture to suspend sample and
pretreatment reagent.
 Pretreatment unload diverter (pUD): Unloads RVs used for sample pretreatments and sample
dilutions from the pretreatment path into the solid waste container.

hardware overview > Primary components of an Alinity ci-series>
Processing modules >Processing module (Alinity i) >Processing
center (Alinity i) >Pretreatment path (Alinity i)
Pipetting hardware
This hardware includes sample and reagent pipettors and sample and reagent wash cups. The
induction heater wash cup is an optional hardware component that can replace the sample wash
cup. One of two configurations will be installed on the system.
Pipettors
Pipettors detect, aspirate, transfer, and dispense samples and reagents into reaction vessels
(RVs). These pipettor assemblies include a pressure-monitoring system that helps to identify
aspiration errors.
1. Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs)
2. Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs
3. Wash cups (R1W, and R2W): Wash any fluid that remains from the interior and exterior surfaces of
probes. In addition, a vacuum source dries the exterior surfaces of probes.
4. Induction heater wash cup (IHW): Washes any fluid that remains from the sample probe interior,
exterior, and tip with wash buffer that is warmed by the heated probe.

Center (Alinity i) > Pipetting hardware (Alinity i)
RV Loader
The RV loader system (RVL) provides the onboard storage for reaction vessels (RVs) and transports
RVs to the process path and the pretreatment path.
1. Upper hopper: Stores bulk RVs loaded by the operator.

2. Lower hopper and RV orienter: The lower hopper stores a limited amount of RVs. The RV orienter
lifts one RV at a time and places the RV in the linear queue.
3. Linear queue: Stages upright RVs in preparation for loading.
4. RV pick and place assembly: Moves RVs one at a time to the process path and the
pretreatment path.
Online Operations Manual (Help): Use or function >Alinity ci-series

hardware overview > primary components of an Alinity ci-series
>Processing modules > Processing module (Alinity i) > Processing
center (Alinity i) > RV loader (Alinity i)
Supply center - Alinity i-series

The supply center is the onboard storage area for bulk solutions and reaction vessel (RV) solid
waste.The supply center Alinity i-series is composed of the:
• Bulk Solution Storage area
• Bulk Solution Reservoir area
• RV waste storage area

hardware overview > primary components of an Alinity ci-series
>Processing modules > Processing module (Alinity i) > Supply cen-
ter (Alinity i)
Bulk solution storage area

 The bulk solution storage area, which is located on the bulk solution door, provides the
onboard storage for replacement bulk solution bottles. Bulk solutions from the replacement
bottles fill onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into
its appropriate key slot in a bottle holder.
Bulk solution reservoir area

 The bulk solution reservoir area, which is located in the supply center, provides the onboard
storage for bulk solutions in use during assay processing. When onboard bulk solution
reservoirs are empty, bulk solutions from replacement bottles on the bulk solution door fill the
reservoirs without an interruption in system operation. Concentrated Wash Buffer from its
onboard bulk solution reservoir is diluted tenfold by the system and is stored in a 4 L diluted
wash buffer reservoir located in the back of the instrument for use during assay processing.
RV waste storage area
The RV waste storage area, which is located in the supply center, provides storage for the RV waste
container and holds used reaction vessels (RVs).
 RV waste chute: Directs the used RVs into the RV waste container. The RV waste container
can be removed during assay processing. When the container is removed, the RV waste
chute closes and holds 50 RVs before the processing module pauses.
 RV waste container: Holds the used RVs. Large empty container in front of RV Waste
Container is a fluid separator that functions to keep water out of the vacuum.
 RV waste storage tray: Holds the RV waste container.

Processing modules > Processing module (Alinity i) > Supply center
(Alinity i)
Reagent supply center - Alinity i-series

• The reagent supply center provides cooled storage at a controlled temperature for up to 47
bar-coded reagent cartridges, maintenance solutions, and frequently used calibrators and
controls.
• The reagent supply center of the Alinity i-series is composed of the:
 Reagent carousel
 Reagent positioner
 Reagent transport
• Reagent carousel: Holds reagent cartridges, maintenance solutions, and frequently used
calibrators and controls. The carousel rotates to provide reagent access to reagent 1 and
reagent 2 pipettors.
 Rotates to position vial racks for transfer to the sample positioner so that onboard calibrators
and controls can be aspirated and dispensed.
 The reagent carousel is a rotating, circular device that performs the following function:
 Provides microparticle dispersion by continuous rotation of microparticle reagent bottles.
• Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or
onto the loading area. When the reagent positioner is in the open position, the cartridge or rack
can be transferred to the loading area. When the reagent positioner is in the closed position, the
cartridge or rack can be transferred to the reagent transport. The reagent positioner then opens
again for the cartridge to be placed in the reagent carousel.
• Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.

Optional Components
The following components are optional for processing modules:
• Uninterrupted power supply (UPS)-Provides a temporary, continuous flow of power to the
processing module during a power failure
• External waste pump- Moves waste from the waste outlet to an elevated drain
• High concentrated waste bottle (c-series)- Collects the high-concentration liquid waste from the
cuvettes and the ICT unit

hardware overview > Primary components of the Alinity ci-series >
Processing modules > optional component
Activity 1: Identify Alinity i-series processing module (front view) exterior

components
Purpose: To become proficient at identifying the Alinity i-series processing module front exterior
components.
Item Definition
___ A - Front processing 1. Provides access to the RV hopper to
center cover replenish reaction vessels (RVs).
___ B - RV hopper cover 2. Provides access to the bulk solution

storage area and the RV waste storage
area.
___ C - Bulk solution door 3. Provides access to components that

perform assay-processing activities.

Processing modules > Processing module (Alinity i)
Activity 2: Identify Alinity i-series processing module (rear view) exterior

components
Purpose: To become proficient at identifying the Alinity i-series processing module rear exterior
components.
Item Definition
___ A - Rear processing 1. Provides access to instrument electronics.
center cover
___ B - Rear access panel 2. Provides additional access to processing
center components.
___ C - Rear electronics 3. Powers on and powers off the power

panel supply.
___ D - Processing 4. Provides access to the components that

module main power perform assay-processing activities.
breaker
___ E - Rear fluidics panel 5. Provides access to pumps and syringes.

Processing modules > Processing module (Alinity i)
Activity 3: Identify processing center Alinity i-series components
Purpose: To become proficient at identifying the Alinity i-series processing center components.
Actions: Using the Operations manual (Help), list four categories of the processing center (Alinity
i) components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

center (Alinity i)
Activity 4: Identify Alinity i-series supply and pump center hardware

components
Purpose: To become proficient at identifying supply and pump center hardware (Alinity i-series)
components.
Actions: Using the Operations manual (Help), list three categories of the supply center (Alinity i)
components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Processing modules > Processing module (Alinity i) > Supply center
(Alinity i)
Activity 5: Identify Alinity i-series reagent supply center components
Purpose: To become proficient at identifying reagent supply center (Alinity i) components.

Actions: Using the Operations manual (Help), list three categories of the reagent supply center
(Alinity i) components.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Knowledge Check: System Hardware (Alinity i)

1. True or false? The reagent supply center provides cooled, temperature-controlled storage for
reagent cartridges, maintenance solutions, and frequently used calibrators and controls.
Answer:
2. Which of the following methodologies is used by the Alinity i-series?

a) RIA
b) Photometric
c) CMIA
d) Potentiometric
Answer:
3. True or False? The supply center is the storage area for bulk solutions.
Answer:
System Software
The Alinity system software has a user interface that is designed to provide access to system
information, software functions, and Help for an active screen. The user interface is a display
format where the operator can select icons, buttons, menu commands, and other screen
elements.
The user interface is common among all Alinity systems.
After completing this lesson, you should be able to:
 Identify the main elements of the User Interface (UI) screen.
 Identify the main elements of the menu bar.
 Identify the main functions of the Home screen.
 Lock the User Interface (UI).
 Log on as General Operator/Admin.
 Identify the Alinity ci-series statuses.
 Application Specialist: Perform FSE logon and CSC logon.
Access Types
The User Interface allows various login types, it has three types of access levels:
User Interface Description
General Operator Used to display the current operator ID on various

screens and to print the operator ID of the current
user on printouts and reports.
Supervisor Used to perform supervisor functions such as the
following examples:
• Configure automatically generated reports.

• Configure quality control settings.
• Configure user-defined maintenance.
• Configure audio settings.
• Configure calibrator settings.
System Used to perform administrator functions such as the
Administrator following examples:
• Configure system settings.

• Approve maintenance logs.
• Install and uninstall assays. Accept Abbott Mail
Items.
• Approve maintenance logs.
• Install and uninstall assays. Accept Abbott Mail
Items.
The Log on screen is used to enter an operator ID and a four-digit numeric pin to log on to the
system.
• The Plus button displays a box that is used to enter the operator ID.
• The + Done button displays the operator ID that was entered.
• Four operator logon buttons display the identification of the last four operators who logged on to
the system. Operators listed can use this option instead of using the Plus button.
The default logon is Admin (system administrator) and the default ADMIN password is 8642.
Virtual Keyboard
Demonstration: Use of virtual keyboard
The facilitator will demonstrate that keyboard comes up when a field that
requires text is selected. Review all the functions that can be used with the virtual
keyboard.
Log On
1. If the Log On screen is displayed, proceed to step 2.
• If any other screen is displayed, tap the Lock button.

2. Tap an operator logon button.
• If the appropriate operator logon button is not displayed, perform the following steps:
 Tap the Plus button.
 Type the operator ID.
 Tap the + Done button.
3. To display the Home screen, tap the four-digit PIN for the operator ID.
Note: A four-digit PIN may or may not be required for

a general operator depending on how the
system is configured. If a PIN is not required,
when the general operation hits the +Done
button, the home screen will appear.
Demonstration: Lock the User Interface (UI)

The User Interface can be locked when not in use by using the lock button
icon located in the screen header. They system will also automatically
lock after 10 minutes of inactivity (default).
When the User Interface is locked, the operator is not logged off. Any sam-
ples that are in process will generate results with the last logged on opera-
tor ID until a new operator performs a log on.
The facilitator will demonstrate how to lock the User Interface (UI) and discuss the
components of the lock screen.
Online Operations Manual (Help): Operating instructions > Log On

screen> Log On screen element descriptions
Demonstration: Log on as Admin, FSE, and CSC
The facilitator will demonstrate how to log on to the system as an Admin, FSE, and
CSC.
 Level of access (from highest to lowest) is

FSE-CSC-Administrator-Supervisor-General Operator.
 Admin password default is 8642. We do recommend that the
customer administrator change the password.
 FSE/CSC logon password is generated by using the Abbott Medical
Device Password Generator. This can be accessed via the Internet
or via an app. You will need to have permission and then enter a
challenge sequence generated from Alinity. The password
generated by AMDPG will be a random sequence of six numbers
with thousands of possible combinations. The challenge sequence
is also a random series of numbers and letters generated by the
Alinity instrument, which changes every 24 hours.
 Supervisor is not a separate log-on, but instead a level of access
that can be assigned to a user.
Procedure Map Reference: Setup > Log on
User Interface (UI)
The Home screen provides the operator the ability to see system information and module status. The
Home screen is where you can change the instrument statuses. This information will be described in
more detail later in this module. The Home screen allows the operator to navigate to different areas
of the software.
• Identify each component of the software.
• The menu bar is static, while the screen information changes. There are seven key areas of the
User Interface (UI):
1. Menu bar: Provides navigation elements and status indicators. Each icon on this bar represents a
screen category. When an icon is selected, an associated screen is displayed. The Alert Center
at the top of this bar indicates when alerts and notifications occur on the system and provides
access to details about alerts and notifications.
2. Screen header: Provides the screen title, the system name, the Help button, the Notepad button,
the name of the logged-on operator, the Lock button, the date and time, and the software
version. The header also contains the Abbott “a” symbol, which functions to print the current
screen to a printer or a USB drive.
3. Information area: Provides access to all system information and functions associated with the
selected screen element.
4. Function buttons: Provide access to functions associated with the active screen. Buttons with
blue text are available for use. Buttons with purple text are unavailable for use until a screen
element is selected.
5. Flyout: Provides additional details or additional functions associated with the active screen.
6. Critical Message: Provides information about conditions or errors of system operation.

7. Help button: Provides access to the Help for the active screen, a flyout, or a message code.
Online Operations Manual (Help): Use or function > Alinity system

software overview
Menu bar
The following are the main components of the menu bar:

• Alert Center.
• Icons, including the System button
 Home Icon
 Sample Status Icon
 Orders Icon
 Results Icon
 QC Icon
 CAL Icon
 Reagents Icon
 Supplies Icon
 System button. System button has the following commands
 Cal/QC inventory
 Procedures Log
 Abbott Mail
 Configure
 System Logs
 Utilities
 Operations Manual (Help)
 Configurable icons
 The two navigational elements can be configured. Default for these is Procedures and
Create order.

software overview > Menu bar
System Status bar

• The system status bar provides system-monitoring information and status information for devices
connected to the system. The following status may be displayed on the System status bar:
 Host
 Printer
 Alinity PRO
 LAS
 Abbottlink
 Abbott Mail
• A green button = operating with no errors
• A red button = communication is unavailable
Online Operations Manual (Help): Operating Instructions > Home

screen element descriptions-scroll to system status bar or there is
an error condition
Demonstration: How to use notepad function
The facilitator demonstrates functions that can be used in notepad:
• Create a note
• Add a comment to a note
• Delete notes from the personal view of the operator
• Pin or unpin notes that the operator created
Online Operations Manual (Help): Operating instructions > Note-

pad flyout
Information area
• RSM Image
• Processing module Image Displays the module type, the module name, the module number,
and the current status of the processing module. A separate image is displayed for each
processing module in the system. The following status updates are displayed on the processing
module image:
 Instrument status
 Reagent status
 Supply status
 QC status
 Calibration status
 Maintenance
 Tests in Progress
 Total Samples
 Sample Status button
 Exceptions
 Exceptions button
 Orders Pending
 Orders button
Online Operations Manual (Help): Operating instructions > Home

screen > Home screen element descriptions-scroll down to Infor-
mation area
Function buttons
 Shutdown
 Start
 Stop
 Pause
 Run
 Text Size
Activity 1: User interface (UI)
Purpose: To become proficient at identifying the areas of the User Interface (UI).
Actions: List the 7 areas of the User Interface (UI).
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

software overview
Activity 2: Menu Bar
Purpose: To become proficient at identifying the main components of the menu bar.
Actions: List the 3 main components of the menu bar.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

software overview > Menu bar
Activity 3: Home screen
Purpose: To become proficient at identifying the function of the home screen.

Actions: List the 12 main functions of the Home screen.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

screen
Activity 4: Log On
Purpose: To become proficient at logging on to the system.

Actions: Practice logging on.
Online Operations Manual (Help): Operating instructions > Log on

screen
Procedure Map Reference: Setup > Log on > Log on
Application Specialist Activity: Login as Admin, CSC, FSE
Purpose: To become proficient at logging on to the system with various identities.

Actions: Practice logging on as Admin, CSC, FSE.
Online Operations Manual (Help): Operating instructions > Log on

screen
Activity 5: Lock the User Interface (UI)
Purpose: To become proficient at locking the User Interface (UI).

Actions: Practice locking the User Interface (UI).
Procedure Map Reference: Setup > Log on > Lock the user inter-
face (UI)
Knowledge Check: System Software

1. Select the location of the alert center.
a) Within the screen header.
b) At the top of the menu bar.
c) Inside the screen.
d) As a function button.
Answer:
2. Select the location where you would find the user logged on to the system.
a) The menu bar.
b) The screen
c) The screen header
d) The help
Answer:
3. Select all items that can be found in the menu bar.

a) Alert Center
b) Configurable icons
c) Operations Manual (Help)
Answer:
4. True or False? When logging on, as an additional identification of the operator, a four-digit PIN
must be used.
Answer:
5. True or False? When you lock the user interface, the operator does not get logged off.
Answer:
Online Documentation: Definition

Learning to use the Alinity ci-series Operations Manual (Help) helps to save time, avert trouble,
and confidently operate the system.
The Alinity ci-series Operations Manual (Help) is included in the user interface and is accessed
from the following:
 Menu bar
 Help button
Using online documentation

The facilitator will identify and describe using the online documentation, including:
 How to access Operations Manual (Help).
 The organization of Operations Manual (Help).
 Navigation and use of Operations Manual (Help).
 How to locate and use the Procedure Map.
Access the Online Operations manual
Procedure Map Reference: Help on Help > Access the operations

manual > Access the operations manual
To access the Alinity ci-series Operations Manual (Help), perform one of the following
procedures:
• On the menu bar, tap System, and then tap Operations Manual (Help).
• Tap the Help button located at the top of an active screen.
The organization of the Alinity ci-series Operations Manual (Help)

 Text conventions
 Italic-indicates a reference to related information
 Bold-emphasizes key words in procedures
 Bracketed numbers- references specific areas of a graphic
 Content Conventions
 Safety symbols and the CAUTION signal word: identifies activities that expose the operator
to potentially dangerous conditions.
 IMPORTANT signal word: Advises the operator to comply with precautions to prevent
negative impact on system operations or results.
 NOTE signal word: Provide information that is relevant to the topic content.
 Related information list: Provides references at the end of a topic that are related to a
topic.
 Graphic conventions
 Numerical References: Indicates items in a graphic that are described in the legend.
Online Operations Manual (Help): System documentation > Con-

ventions for the operations manual
• The operations manual contains the following areas:

 Toolbar
 Navigation pane
 Topic pane
Navigation and use of the Operations Manual (Help)
The facilitator will explain each touch action while navigating and using the Operations Manual
(Help):
• Press: touching the surface for an extended period of time.
• Tap: briefly touching source with fingertip.
• Flick: quickly brushing the surface with the fingertip to scroll through items on the screen.
• Drag: moving fingertip over surface without losing contact.
• The facilitator will demonstrate the following:
 Scroll through a topic or table of contents.
 Play animations. For example, RSM component animation - Use or function > Alinity ci-series
hardware overview > Primary components of an Alinity ci-series > Reagent and Sample
Manager (RSM.)
 Access related information. Point out that these occur at the end of the topic so one may
need to scroll to see the related information topics.
 Use breadcrumbs to access topics. Breadcrumbs provide a navigational aid, allowing the
user to keep track of locations within the Online Operations Manual (Help).
 Redisplay a topic using the Back or Forward button.
 Page through the content using the Previous topic or Next topic button.
 Use the Toggle TOC button to display or hide the Table of Contents tab.
 Use the index.
 Use the glossary.
 Search for a term.
 Resize, move and close the Online Operations Manual (Help).
Online Operations Manual (Help): System documentation > Oper-

ations manual use
How to locate and use the Procedure Map

• The Procedure Map is grouped into task-related categories.
Online Operations Manual (Help): System documentation > Proce-

dure map description
The Procedure Map button and the following job-related categories are:
 Procedure Map button
 Sample processing
 Quality control
 Manage data
 Help on Help
 Maintenance
 Troubleshooting
 Setup
 Calibration
Activity 1: Using the Alinity ci-series Operations Manual (Help)
Purpose: To become proficient at using the online Alinity ci-series Operations Manual (Help).
Actions: Using the online operations manual, do the following steps:
 On the menu bar, tap System, and then tap Operations Manual (Help) to display the
operations manual.
 From the Contents tab, tap the System documentation book.
 Tap Organization of the operations manual to view the topic and scroll through the
description information.
 In the Related information section, tap Topic Pane.
 In the breadcrumbs, tap System documentation to return to the System documentation
topic.
 From the Glossary tab, scroll to and tap menu bar.
 In the Search box, type Hazards and tap the Search icon.
 From the Search tab, flick through the list and tap Safety icons.
 Using the divider handle, drag the divider line between the navigation and topic panes to
the right or left to enlarge or decrease the navigation and topic panes.
 Tap and hold the title bar and drag the Help to a new location.
 From the upper right-hand corner, tap the Close button.
Discussion: Discuss any problems that the participants may have encountered.
Online Operations Manual (Help): System documentation > Oper-

ations manual use
Activity 2: Using the Procedure Map
Purpose: To become proficient at using the procedure map.

Actions: Using the Procedure Map, do the following steps:
 Tap the Procedure Map button.
 Tap the Help on Help category.
 Tap View topics.
 Tap Play an animation.
 Tap the Back button and return to Help on Help tasks.
Discussion: Discuss any questions that may arise during the activity.
Procedure Map Reference: Help on Help > Find Specific Informa-

tion > Display and use the procedure map
Activity 3: Access Screen help
Purpose: To become proficient at accessing online help.

Actions: On the left hand side of the home screen, press on the Orders icon. Then locate the
screen Help button and access the Alinity ci-series Operations Manual (Help). Note what page
the Help opened to.
Discussion: Discuss any questions the participants may have.
Online Operations Manual (Help): System documentation> Opera-

tions Manual use> Access the operations manual
Review
1. True or False? The Note pad allows a user to pass along important information to the next.
Answer:
2. Select all of the following that are components of the System Control Module.
a) A user interface computer.
b) Hardware and software to operate the RSM.
c) The power supply to operate the User Interface (UI) computer and the (RSM).
d) Bulk storage area that contains all of the bulk solutions.
Answer:
3. True or False? All Alinity ci-series are composed of a System Control Module (SCM), an RSM, and
a processing module.
Answer:
4. Select the action an operator should do when they approach the system and find the monitor
positioned above their head.
a) Leave it in that position because it cannot be adjusted.
b) Move it to the right.
c) Adjust it to be at a comfortable eye level.
Answer:
5. Which one of the following is the onboard storage area for replacement bulk solution bottles for
the Alinity ci-series?
a) Reagent supply center
b) Reagent and Sample Manager
c) Bulk solution storage area
d) Bulk solution reservoir area
Answer:
6. Select the location for the main power breaker to the Alinity c-series processing module.
a) The right front of the processing module.
b) There is not a main power switch for the Alinity c-series processing module.
c) The processing module is powered off using the User Interface (UI).
d) The lower left of the back of the processing module.
Answer:
7. Which one of the following is the onboard storage area for bulk solutions and reaction vessel
(RV) solid waste for the Alinity i-series?
a) Supply center (Alinity i-series)
b) Reagent supply center
c) Reagent and Sample Manager
d) RV loader
Answer:
8. Select the location for the main power switch to the Alinity i-series processing module.
a) The right front of the processing module.
b) The lower left of the back of the processing module.
c) There is not a main power switch for the Alinity i-series processing module.
d) The processing module is powered off using the User Interface (UI).
Answer:
9. Select all of the following information the Screen header provides.

a) Screen title and system name
b) Help and Notepad buttons
c) Date and time
d) Function buttons
e) Name of the logged-on operator
Answer:
10. True or False? To find information about the screen that is currently displayed, select the question
mark displayed on that screen.
Answer:
11. Select all of the following items that can be accessed from the User Interface (UI).
a) System information
b) Current temperature of the laboratory
c) Software function buttons
d) Help
e) Operations Manual (Help)
Answer:
12. True or False? The Home screen displays the total samples, orders pending, and exceptions.
Answer:
Module 2: System Statuses
Estimated Time: 60 minutes
Objectives •• Identify the various statuses of the processing module and

reagent and sample manager (RSM)
•• Change the status of the processing module and RSM
•• Explain when you would need to cycle power
•• Cycle power to the system
•• Cycle power to the processing module and the reagent and
sample manager (RSM)
Module Topics
Familiarizing yourself with the instrument statuses is essential to ensuring that it performs
appropriately.
•• System Statuses
•• How to change instrument status
•• Cycle power
Alinity ci-series Global Application Training | Internal Use Only | 80002250-101 2-1
Refer to the Alinity ci-series Operations Manual for more

information. The sections relevant to the information presented in
this training module is:
Section 5 Operating Instructions subsections; Home screen and

System cycle power, start, pause, and stop screen
System Statuses
Instrument status refers to the operational modes of the Alinity ci- series.
The status of both processing modules and the reagent and sample manager (RSM) display
on the Home screen.
The instrument status is indicated by the following colors:
•• Green - The instrument status of the module is Running or Processing.

•• Yellow - The instrument status of the module is Idle, Initializing, Warming, Pausing, or
Maintenance.
•• Red - The instrument status of the module is Offline or Stopped.
There are certain tasks you can and cannot perform based on the current status.
2-2 Alinity ci-series Global Application Training | Internal Use Only | 80002250-101
The processing modules and the reagent and sample manager (RSM) have the following
instrument statuses:
Status Description
Offline Indicates when the processing module is not
communicating with the system control module (SCM).
This status is displayed for the following conditions:
•• Power to the processing module is off.

•• Power to the processing module has been turned on, but
communication between the module and the SCM has
not been reestablished.
•• Communication failure between the processing module
and the SCM has occurred because of a software error
or a system error.
Stopped Indicates when the processing module is turned on and is

communicating with the SCM.
•• Power to the processing module is on, but Start on the

Home screen has not been selected.
•• Stop on the Home screen was selected.
•• A diagnostic procedure has completed.
•• A procedure has completed with an error.
•• A fatal error was detected during assay processing.
Start on the Home screen must be selected to initialize the

processing module and to transition the status to Idle.
Initializing Indicates a temporary status that occurs when Start or Run
on the Home screen is selected.
After initialization is completed, the status transitions to

Running, Processing, or Idle based on whether Start or Run
on the Home screen was selected.
Initialization is specific to a module. Based on the module,

the following functions are performed:
Status Description
c-series
•• Initialization after Start is selected:

Confirms that the volume of water dispensed from the
cuvette washer is adequate
•• Initialization after Start or Run is selected:
Homes the motors
Confirms that processing center covers are closed
Verifies that the reagent carousel inventory is
adequate
Confirms that racks and cartridges are not located on
Confirms that the volume of the bulk solutions is
adequate
Confirms that the volume of the sample onboard wash
solutions is adequate
•• Initialization after Run is selected:
Washes the probes
Washes the cuvettes
Verifies that the supply inventory is adequate
i-series

Homes the motors
Confirms that processing center covers are closed
Confirms that the RV unloader is in the correct position
Performs a vacuum check
Verifies that the reagent carousel inventory is
adequate
•• Initialization after Run is selected:
Washes the pipettor probes
Starts the mixing of the microparticles
Verifies that the supply inventory is adequate
Performs a background check
Fills the process path load lane with clean reaction
vessels (RVs)
Clears RVs from the pretreatment path and adds
clean RVs
Status Description
RSM
Homes all moving parts
Confirms that front processing center covers are
closed for each processing module
Confirms that the bar code reader is functioning
correctly
Homes the sample positioner for each processing
module
the sample positioners or the RSM transport
Warming Indicates when the processing module has completed
initialization but has not reached the required temperature
NOTE: This status is not displayed for the RSM.

Idle Indicates when the processing module has successfully
completed initialization and is ready to accept a run
request.
•• Start is initiated and is completed (including temperature

initialization).
•• Pausing status is completed.
Running Indicates when the processing module has successfully
completed initialization and is ready to process tests.
•• Run on the Home screen was selected.

•• Tests have completed processing, but Pause or Stop on
the Home screen has not been selected.
Processing Indicates when the processing module is actively
processing tests.
For c-series, this status is displayed after Run on the Home

screen is selected and initialization is completed. During
this time, cuvettes are washed and filled with water. If
a sample is not loaded on the RSM, the module status
transitions to Running after these activities are completed.
NOTE: This status is not displayed for the RSM.
Status Description
Pausing Indicates when the processing module is not aspirating
samples and is completing assay processing before the
module status transitions to Idle or Stopped.
The module status transitions to Idle for the following

conditions:
•• Pause on the Home screen was selected.

•• Supply inventory is insufficient.
When an error is detected during assay processing, the

module status transitions to Stopped.
Maintenance Indicates when a maintenance procedure or a diagnostic
procedure is in process on the processing module.
Changing System Status

You can change the status from one type to another by pressing certain function keys on
the Home screen.
The progression of instrument statuses from Offline to Running and the approximate duration
of each transition is shown in the tables below.
The timeframe to change from one status to another varies depending on the status type
and any processing currently taking place on the instrument.
Initiate or Resume Sample

Processing
Initiate or resume sample processing is used to process a run after ordering and loading
samples or to resume sample processing after pausing or stopping the processing module or
the reagent and sample manager (RSM).
The instrument must be in Stopped, Idle, or Pausing status.
1. On the menu bar, tap the Home icon.
2. On the Home screen, perform one of the following steps:
•• Tap one or more of the processing modules or the RSM.

•• Tap one or more of the processing modules and the RSM.
3. Tap Run.
Cycle Power to the System

To perform certain tasks, the operator may need to cycle power to the entire Alinity ci-series,
to the reagent and sample manager (RSM), or to one or more processing modules.
To cycle power, the specific component must be powered off and then must be powered
on after a certain time period has elapsed.
After the power is on, a start must be performed to transition the instrument status to Idle.
Based on the instrument status of the RSM and the processing module, a pause may be
required so that the following tasks can be performed:
•• Maintenance and diagnostics

•• Component replacement
•• Loading of c-series sample onboard wash solutions
Required Instrument Status

Processing module: Offline, Stopped, Warming, or Idle
Reagent and sample manager (RSM): Offline, Stopped, or Idle
NOTE: The instrument status for each processing module and the
RSM must be one of the required statuses to ensure that sample
processing is not interrupted.
Procedure
There are two procedures to cycle power.
Cycle power to the system
This procedure will cycle power to the system control module (SCM), the RSM, and one or
more processing modules.
It is used to reestablish communication among the system components, to store

configuration information, or to troubleshoot the system. All tests will be terminated when this
procedure is done.
Cycle power to the processing module and the

reagent and sample manager (RSM)
This procedure cycles power to the processing module and the RSM without shutting down
the software.
This procedure is used to reestablish communication with the system control module (SCM),
to store configuration information, or to troubleshoot the system
Refer to the Alinity ci-series Operations Manual Section 5 Operating

Instructions subsection; System cycle power, start, pause, and stop
for the procedures to cycle the power.
To locate the procedures using the online Procedure Map
Refer to the following locations:
-Troubleshooting> System cycle power, start, pause, and

stop>Cycle the power to the system
-Setup>System start, pause, and shutdown>Cycle the power to the

processing module and the reagent and sample manager (RSM)
Power Switch and Main Power

Breaker Locations
SCM Power Switch
When the SCM power switch is turned off, the power is turned off to the RSM for each
processing module in a multimodule system and for the SCM bar code scanner.
If only the front power switch of a processing module is off, the reagent carousel power is
maintained. To turn off all power to the processing module, move the main power breaker of
the module to the off position.
Activity 1: Cycle Power to the System
Purpose: To be familiar with cycle power procedures
Actions:
1. Locate the Cycle Power to the System procedure in the Operations Manual. (Print)
2. Perform Cycle Power to the System procedure.
Discussion: Discuss any questions or issues that may arise from the activity.
Activity 2: Start the processing module and the reagent and sample manager
(RSM)
Purpose: To be familiar with initialization process of processing module and RSM
Actions:
•• Start the processing module and the reagent and sample manager (RSM).
•• Watch and Listen as the instruments go through their initialization processes
Review
1. Select all of the statuses in which you can cycle power to the processing module:
a) Stopped
b) Idle
c) Running
d) Maintenance
e) Warming
f) Offline
2. To go from a Stopped Status to an Idle Status, you perform which one of the following
functions?
a) Load a Sample
b) Tap Run after loading a sample
c) Tap Start
d) Tap Pause
e) Tap Run
3. Select the status that matches this description-indicates a temporary status that occurs
when Start or Run on the Home screen is selected.
a) Running
b) Processing
c) Initializing
d) Warming
4. Which one of the following statements is correct when cycling power to the processing
module and the reagent and sample manager (RSM)?
a) The purpose of this procedure does not include storing configuration information
b) Each processing module must remain powered off for a minimum of 8 hours before
turning back on
c) After the power is turned on, the RSM initializes and the instrument statuses transition to
Offline
d) The instrument status for the RSM must be one of the required statuses(Offline, Stopped,
or Idle) to ensure that sample processing is not interrupted
5. Select the status that matches this description-Indicates when the processing module has
successfully completed initialization and is ready to accept a run request.
a) Processing
b) Running
c) Offline
d) Idle
Module 3: Basic Sample Processing
\
Objectives • After completing this lesson, you should be able to describe

the:
 Describe the basics of the Photometric method (c-series)
 Describe the basics of the Potentiometric method (c-
series)
 Describe Assay processing (c-series and i-series)
 Explain the SmartWash feature (c-series photometric)
 Describe the basics of chemiluminescent microparticle
immunoassay (CMIA) detection technology
Module Topics
An Alinity ci-series System uses various detection technologies to measure analyte concentrations in
samples. In this module, you will explore the:
• Principles of operation (c-series).
• Principles of operation (i-series).
• Types and methods of calibration
Online Operations Manual (Help): Section 3 Principles of operation
Alinity c-series Basic Sample Processing

After completing this section, you should be able to describe the:
• Photometric method
• Potentiometric method
• Assay processing
• SmartWash feature
• Sample interference indices
Description
This principles of operation for the c-series lesson provides an overview of photometric and
potentiometric detection technologies, assay processing, and the SmartWash feature used for
analyte measurement. The principles also include an overview of sample interference indices for
lipemic, hemolyzed, and icteric samples.
Demonstration: Principles of operation (c-series)
The facilitator will identify and describe the principles of operation

(c-series), including the:
• Photometric method (c-series).
• Photometric technology (c-series).
• Potentiometric method (c-series).
• Assay processing (c-series).
• Indirect assay processing (c-series).
• SmartWash feature (c-series).
• Optimum sampling sequence feature (c-series).
• Sample interferences (c-series).
Photometric method (c-series)
Review the photometric method (c-series).
Online Operations Manual (Help): Principles of operation >

Principles of operation (c-series) > Photometric method (c-series).
Photometric technology (c-series)
Photometric technology measures the amount of light a sample absorbs. A beam of light is passed
through a sample and the intensity of light that reaches a detector is measured.
Beer's Law establishes the mathematical relationship between the absorbance of the solution and
the concentration of the analyte.
The absorbance of the solution changes as the reaction progresses. Measurements occur either
when all the reactant is depleted and the reaction is stable (end-point assays) or when the reactant
reaches a stable rate(rate assays).
Examples of photometric technology are:
• End-point assay reactions (c-series).
• Rate assay reactions (c-series).
The c-series uses an optical measurement to obtain absorbance readings and then converts them
to assay-specific analyte concentration units or assay-specific qualitative interpretations.

Principles of operation (c-series) > Photometric method (c-series) >
Photometric technology (c-series)
Optical system and measurement sequence (c-series)
The optical system on the processing module is a direct photometry system that directs and aligns
the light from the source lamp, through the water bath and the cuvette, to the optics unit. The
optical system directs and aligns only the light that originates from the source lamp and
simultaneously measures the intensity of 16 different wavelengths.
Potentiometric method (c-series)
Potentiometric technology measures the electrical potential in a sample.
The c-series uses an integrated chip technology (ICT) module to measure potentiometric assays
(electrolytes).
The ICT module contains the following electrodes: Sodium (Na+), Potassium (K+), and Chloride (Cl-).
• During ICT Reference Solution delivery and processing, the ICT Reference Solution cup is filled
with the ICT Reference Solution, which is analyzed, and then the waste is removed:
 The syringe on the left side of the ICT Reference Solution pump moves the ICT Reference
Solution from the bottle, through the warming ring, and into the ICT Reference Solution cup.
 The ICT unit moves down to position the ICT probe in the ICT Reference Solution cup.
 The syringe on the right side of the ICT aspiration pump aspirates the ICT Reference Solution
from the cup into the ICT module.
 The ICT module measures the ICT Reference Solution. The system converts the measurements
into millivolt readings that are used for reference when sample result concentrations are
calculated.
 High-concentration waste processing begins: The syringe on the right side of the ICT
aspiration pump moves the ICT Reference Solution from the ICT module to the
high-concentration waste compartment.
 The syringe on the left side of the ICT aspiration pump moves the liquid waste from the
 The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high
concentration waste tubing.
 Low-concentration waste processing begins: The syringe on the right side of the ICT
Reference Solution pump moves the remaining ICT Reference Solution from the ICT
Reference Solution cup.
 The syringe on the right side of the ICT Reference Solution pump moves the solution to the
low-concentration waste compartment in the water bath overflow and waste area.
 Gravity causes the liquid waste to drain from the low-concentration waste compartment in
the water bath overflow and waste area to the low-concentration waste tubing.
• ICT Sample Delivery

During ICT sample delivery and processing, the sample and the ICT Sample Diluent are
dispensed, the sample is analyzed, and then the waste is removed:
 The sample pipettor dispenses 15 μL of sample into a cuvette.

 Reagent pipettor 1 dispenses 69 μL of ICT Sample Diluent (ICTD5) and 276 μL of water into the
cuvette.
 Mixer 1 mixes the sample, the diluent, and the water.

 The reaction carousel continues to rotate until the cuvette aligns with the ICT unit. The
cuvette alignment occurs after 37 reaction carousel movements.
 The ICT unit moves out and down to position the ICT probe in the cuvette.
 The syringe on the right side of the ICT aspiration pump aspirates the sample from the
cuvette into the ICT module.
 The ICT module measures the sample. The system converts the measurements into millivolt
readings that are used to calculate sample result concentrations.
 The syringe on the right side of the ICT aspiration pump moves the sample from the ICT
module to the high-concentration waste compartment
 The syringe on the left side of the ICT aspiration pump aspirates the liquid waste from the
 The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high
concentration waste tubing.
Note: It is normal for bubbles to appear in the right syringe of the ICT reference solution pump and
the left syringe of the ICT aspiration pump.
• Data reduction calculation is used to calculate the final result concentration. For each sample,
the system compares millivolt readings from the sample to millivolt readings from the ICT
Reference Solution that is analyzed immediately after the sample. The difference in the millivolt
readings is used to calculate assay results.

Principles of operation (c-series) > Potentiometric method
(c-series).
Features of the Potentiometric method (c-series) are:

• Uses integrated chip technology (ICT). The ICT module is an integrated chip that is a component
of the ICT unit and contains the sodium (Na+), potassium (K+), chloride (Cl-), and reference
electrodes. The warranty for the ICT module is 20,000 samples or 3 months after installation,
whichever occurs first.
• Measures Sodium (Na+), Potassium (K+), and Chloride (Cl-).
Sample processing (c-series)

• Reaction carousel movement
The movement of the reaction carousel, the timing of these movements, and the position of the
components cause each reaction activity to occur at a specified time and location. During
assay processing, the reaction carousel rotates counterclockwise one-fourth turn every 4
seconds to position the cuvettes at each location. Each rotation moves incrementally to 47
cuvette positions in the reaction carousel. As each rotation occurs, the cuvettes pass the
photometric position where the lamp is located, and the photometer measures the absorbance
of each cuvette. The maximum reaction time is 10 minutes.
The following are the assay protocols or assay-processing methods on the instrument.
• Assay processing for a one-reagent protocol
• Assay processing for a two-reagent protocol
• Assay processing for a dilution protocol
• Assay processing for a pretreatment protocol
• Assay processing for an ICT protocol

Principles of operation (c-series) > Assay processing (c-series)
Indirect assay processing (c-series)

• The indirect assay processing method for photometric assays provides for two results to be
generated from one cuvette during a single assay processing cycle.
• This option is available only when the assay parameters are installed from an assay file that is
provided by Abbott Laboratories.
• The two assays must be ordered at the same time when calibrations, specimens, and controls
are processed. Each assay generates its own calibration, control results, and specimen results.

Principles of operation (c-series) > Indirect assay processing
method (c-series).
SmartWash feature (c-series)

• SmartWash is a c-series feature that provides an additional wash process (when needed) for
reagent probes, sample probes, and cuvettes.
• The SmartWash feature is used during assay processing to reduce interference (carryover)
between specific assay combinations.
• The configuration of SmartWash parameters for Abbott reagents is determined by reagent
carryover studies which identify assay pairs that do not meet the reagent carryover criteria.
The following features of SmartWash are:

• Configure the assay combination as a SmartWash pair to reduce reagent carryover between
assays known to demonstrate it.
• To minimize the consecutive measurement of assays configured as SmartWash pairs, the c-series
uses the optimum sampling sequence feature, which automatically changes the sampling
sequence.

Principles of operation (c-series) > SmartWash feature (c-series).
Optimum sampling sequence feature (c-series)
The optimum sampling sequence feature consists of:

• An automatic process in which the c-series rearranges the sampling sequence to maximize
processing speed and system throughput.
• This rearrangement prevents the consecutive aspiration of interfering reagents and therefore
reduces the number of required washes and unused cuvettes.
• If this rearrangement is not possible, the system automatically activates the SmartWash feature.

Principles of operation (c-series) > Optimum sampling sequence
feature (c-series).
Sample interference indices (c-series)

• Review sample interference indices.
• The sample interference indices are sample measurements that estimate the presence of lipids,
hemoglobin, and bilirubin in lipemic, hemolyzed, and icteric samples, respectively.
Features of the sample interference indices protocol are:

• The sample interference indices protocol measures lipemia, hemolysis, and icterus in a sample.
• Saline is configured as a reference photometric assay that the system uses to estimate the
indices for a sample.
• Analysis of the three indices requires one additional cuvette for each sample.

Principles of operation (c-series) > Sample interference indices
(c-series).
Activity 1: Detection technologies c-series system
Actions: List the two detection technologies used by the c-series.
._________________________________________________________________
__________________________________________________________________

Principles of operation (c-series).
_______________________________________________________________________
Activity 2: Sample interference indices
Actions: List the sample interference indices measured on the c-series system.
_____________________________________________________________________
_____________________________________________________________________

Principles of operation (c-series) > Photometric method (c-series) >
Optical measurement (c-series) > Optical system and
measurement sequence (c-series).
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Alinity i-series Basic Sample Processing

After completing this section, you should be able to describe the:
• CMIA methodology (i-series).
• Assay processing (i-series).
Description
This Principles of operation lesson for the i-series provides an overview of chemiluminescent
microparticle immunoassay (CMIA) detection technology, assay processing, and the optical system
used for analyte measurement.
CMIA technology and reaction sequence (i-series)

• Identify the reactants used for the CMIA detection technology.
• Review each step of the reaction sequence.
The following reactants are the necessary reactants for CMIA detection technology:
• Acridinium-labeled conjugate.
• Paramagnetic microparticles coated with capture molecules (antigens, antibodies, or viral
particles) that are specific for the analyte being measured.
• Pre-Trigger Solution and Trigger Solution.
• Sample analyte.

Principles of operation (i-series) > CMIA method (i-series) > CMIA
technology and reaction sequence (i-series).
Sequence of events
1. The sample and the paramagnetic microparticles coated with capture molecules are dispensed
into the reaction vessel (RV). The vortexer mixes the reaction mixture.
2. The reaction mixture incubates. The analyte in the sample binds to the capture molecules on the
paramagnetic microparticles and forms an immune complex.
3. A magnet attracts the paramagnetic microparticles (which are bound to the specific analyte) to
a wall of the RV. The wash zone assembly washes the reaction mixture to remove unbound
materials. Additional assay processing can now occur.
4. The pipettor dispenses a chemiluminescent, acridinium-labeled conjugate into the RV. The
conjugate binds to the immune complex to complete the reaction mixture. The vortexer mixes the
reaction mixture. The reaction mixture incubates.
5. The wash zone assembly washes the reaction mixture to remove unbound materials.
6. The Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution (hydrogen peroxide) into the
reaction mixture. The vortexer mixes the reaction mixture. The Pre-Trigger Solution:
• Creates an acidic environment to prevent the early release of energy (light emission).
• Helps to prevent any clumping in microparticles.
• Separates the acridinium dye from the conjugate that is bound to the microparticle complex.
This action prepares the acridinium dye for the next step.
7. The CMIA optical system performs a background read.
8. The Trigger Solution nozzle dispenses the Trigger Solution (sodium hydroxide) into the reaction
mixture. The Trigger Solution creates an alkaline environment that, with the exposure to peroxide in
the Pre-Trigger Solution, causes the acridinium dye to undergo an oxidative reaction. The oxidative
reaction causes a chemiluminescent reaction to occur. N-methylacridone forms and releases
energy (light emission) as N-methylacridone returns to its ground state.
The CMIA optical system measures the chemiluminescent emission (activated read) over a
predefined time period to determine a result.
Alinity i-series Process Path

• Based on the protocol type, assay-processing steps occur at different positions on the process
path. The i-series process path holds a total of 46 RVs and advances the RVs one position every
18 seconds..
1. At position 1, the sample pipettor dispenses the sample into the RV.
2. At position 2, the reagent 1 pipettor dispenses microparticles and the acridinium-labeled
conjugate.
Note: For a delayed one-step assay, the reagent 2 pipettor adds the acridinium-labeled conjugate
at position 71 and the vortexer mixes the reaction mixture at position 72.
3. At position 3, the vortexer mixes the sample, microparticles, and the conjugate.
4. At positions 4 through 86, the reaction mixture incubates for 25 minutes.
5. At positions 87 through 90, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 94, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
7. At position 98, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical system
performs an activated read.
8. At position 100, the liquid waste arm aspirates the liquid waste from the RV.
9. At position 101, the RV unloader removes the RV and discards it into the solid waste container.
.
Online Operations Manual (Help): Principles of operation > Princi-

ples of operation (i-series) > Assay processing (i-series).
The following are the assay protocols or assay-processing methods on the instrument:
• Assay processing for One Step 25.
 Sample and all reagents are added before microparticles are washed - total time is 29
minutes, including a 25 minute incubation time
• Assay processing for Two Step 18-4.
 Sample and some reagents are added before microparticles are washed, conjugate is
added after wash - total time is 29 minutes, including a 22 minute incubation time
• Assay processing for pretreatment.
 A pretreatment assay protocol has additional steps that are performed before a one-step or
two step assay protocol is performed. The i-series module automatically performs these steps
when pretreatment is required.Based on the pretreatment type, incubation times and the
number of pretreatment reagents vary. Two pretreatment assay protocols are available for
use:
 Pretreatment 7 performs the pretreatment assay protocol once and requires an

additional 7 minutes.
 Pretreatment 7-7 performs the pretreatment assay protocol twice and requires an
additional 14 minutes.
 The pretreatment path holds 61 RVs and advances reactions vessels in two lockstep
durations. It advances RVs at 3 seconds, followed by a 15-second lockstep for a total of
two positions every 18 seconds. After the pretreatment assay protocol is completed, the
sample is transfered to the process path.
• STAT assay processing for One Step 11.

 Sample and all reagents are added before microparticles are washed - total time is 15
minutes, including a 11 minute incubation time
• STAT assay processing for Two Step 4-4
 Sample and some reagents are added before microparticles are washed, conjugate is
added after wash
 Total time is 18 minutes, including a 8 minute incubation time
Activity 1: Identify the necessary reactions in the CMIA reaction
Actions: List the reactants for CMIA detection technology.
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
Online Operations Manual (Help): Principles of operation > Princi-

ples of operation (i-series) > CMIA method (i-series) > CMIA tech-
nology and reaction sequence (i-series).
Review
Complete the following questions to check your knowledge of principles of operation

1. Select all of the following reactants and analytes that are necessary for chemiluminescent
microparticle immunoassay (CMIA) detection technology:
a) Paramagnetic microparticles coated with capture molecules (antigens, antibodies, or viral
particles) that are specific for the analyte being measured.
b) Sample analyte that is measured
c) Acridinium-labeled conjugate.
d) Pre-Trigger Solution.
e) Trigger Solution.
Answer:
2. True or False? The CMIA optical system measures the chemiluminescent emission (activated
read) over a predefined time period to determine a result.
Answer:
3. True or False? The sample interference indices protocol could be used if a sample was
hemolyzed.
Answer:
4. Select all of the electrolytes measured by the integrated chip technology (ICT):
a) Sodium (Na+).
b) Potassium (K+).
c) Magnesium.
d) Chloride (Cl-).
Answer:
5. Match the c-series detection technology with its corresponding definition.
Detection Technology Definition
1 Measures the electrical potential

in a sample using an integrated
_____ (A) Photometric
chip technology (ICT) module to
technology
measure potentiometric assays
(electrolytes).
2 Measures sample absorbance

____ (B) Potentiometric for the quantitation of analyte
technology concentration using a beam of
light.
6. Select the three components used in the potentiometric calibration method.

a) Electromotive force measurement.
b) Inertia force.
c) Slope calculation.
d) Sample measurement.
Answer:
Module 4: Consumables and Inventory Management
Module 4: Consumables and Inventory

Management
Objectives: • Define a consumable

• Identify the required consumables
• Replace and update the consumable inventory
• Identify and prepare the reagents used in the Alinity ci-series
• View or print assay inserts
• Prepare onboard solutions and sample diluents
• Identify the required accessory for reagents of the Alinity
ci-series
• Load/Unload trays and cartridges into the reagent sample
manager (RSM)
• Unload reagents from the reagent and sample manager
(RSM)
Module Topics
This module will provide you with basic knowledge about consumable inventory management. In
this module, you will learn about the required consumables, reagents, and accessories. All of these
are essential to ensure the instrument functions and performs appropriately. It is important to
effectively manage the consumable inventory to allow for the uninterrupted processing of samples.
• Consumables
• Reagents
• Accessories and Supplies
Online Operations Manual (Help):

Section 1 Use or function subsections; Required consumables and
Required accessories
Section 5 Operating Instructions subsections; Consumable Inven-

tory management and Reagent and sample management
Section 7 Operational precautions and limitations subsection;

Requirements for handling the consumables
Consumable Inventory Management

• After completing this lesson, you should be able to:
 Define a consumable.
 Identify the required consumables.
 Application Specialist: Discuss onboard stability and percent remaining. Focus on training the
customer when it is appropriate to replace bulk solutions in the bulk solution storage area.
 Replace and update the consumable inventory.
Definition
• Required consumables are replenishable items that are needed for sample processing on the
system. Reagents are solutions used in system operation and sample processing.
• Consumable inventory management includes procedures to prepare and replenish supplies and
to empty waste. Always maintain an adequate inventory of required consumables. Use the
supplies screen to view and manage in-use supply inventory.
• The facilitator will identify and describe the required consumables and demonstrate replacing
and updating the inventory of the required consumables, including:
 Required consumables (Alinity c-series)
 Required consumables (Alinity i-series)
 Verify the supply and waste inventory
 Replace bulk solutions and update the inventory
 Replace sample onboard wash solutions and update the inventory (Alinity c-series)
 Remove the RV waste and update the inventory (Alinity i-series)
 Replenish reaction vessels (RVs) and update the inventory (Alinity i-series)
Required consumables (Alinity c-series)

 The facilitator will Identify the consumables of the Alinity c-series.
• The required consumables of the Alinity c-series are:
 Bulk solutions:
 Alkaline Wash (0.5 L bottle): An alkaline wash solution that is used by the cuvette washer
to clean the cuvettes after sample analysis. Alkaline Wash is stored at a temperature of
15°C to 30°C and is stable on the system for 30 days.
 ICT Reference Solution (1 L bottle): A mid-concentration standard solution that is aspirated
and analyzed by the ICT module before and after each sample. The solution provides a
reference potential that is used in result calculation. ICT Reference Solution is stored at a
temperature of 15°C to 30°C and is stable on the system for 90 days.
 Acid Wash (0.5 L bottle): An acidic wash solution that is used by the cuvette washer to
clean the cuvettes after sample analysis. Acid Wash is stored at a temperature of 15°C to
30°C and is stable on the system for 30 days.
Online Operations Manual (Help): Use or function > Required con-

sumables > Bulk solutions (Alinity c)
 Sample onboard wash solutions

 The sample wash solution area stores sample onboard wash solutions that are used for the
SmartWash function and maintenance procedures. The area provides space for two
sample tubes in a removable sample wash solution holder.
- Acid probe wash
- Detergent A
 Onboard solutions (c-series)

 Onboard solutions are detergents that are used to wash sample probes, reagent probes,
mixers, and reaction cuvettes. The solutions are used by the SmartWash feature during
system operation. They may also be used during some maintenance and diagnostic
procedures. Onboard solutions include Acid Probe Wash, Detergent A, and Detergent B.
For specific information about each solution, see the product documentation.

sumables> onboard solutions (c-series)
 ICT module (optional)

 Sample cup.
Sample cups are 1400 uL disposable containers that hold samples. Volume graduation marks
at 125 uL, 500 uL, and 1400 uL eliminate the need to pipette with precision.
Solutions used in daily operations (c-series)
Use the operations manual reference below to review the onboard stability dating and placement
of solutions used in daily operations.
Online Operations Manual (Help): Operating instructions > Con-

sumable inventory management > Supplies screen > Solutions
used in daily operations (c-series)
Required consumables (Alinity i-series)

• Identify the consumables of the Alinity i-series.

Processing modules > Processing module (Alinity)

Processing modules > Processing module(Alinity i) > Processing
center (Alinity i) > RV loader (Alinity i)
• The required consumables of the Alinity i-series are the:

 Bulk solutions
 Pre-Trigger Solution (1 L bottle): A solution that contains 1.32% (W/V) hydrogen peroxide
solution that separates the acridinium dye from the conjugate that is bound to the
microparticle complex. This action prepares the acridinium dye for the addition of Trigger
Solution. Pre-Trigger Solution is sensitive to light, is stored at a temperature of 2°C to 8°C,
and is stable on the system for 16 days.
 Trigger Solution (1 L bottle): A solution that contains 0.35N sodium hydroxide solution that
produces the chemiluminescent reaction that provides the final read. This solution is
stored at a temperature of 2°C to 30°C and is stable on the system for a maximum of 28
days. Some assays require a shorter onboard stability period. For more information, see
the assay documentation.
 Concentrated Wash Buffer (2 L bottle): A solution that contains phosphate-buffered saline
and antimicrobial agents. This solution is diluted tenfold by the system and then is pumped
to sample and reagent pipettor assemblies and to wash zones during assay processing.
This solution is stored at a temperature of 15°C to 30°C and is stable on the system for 30
days.
Solutions used in daily operations (i-series)
Use the operations manual reference below to review the onboard stability dating and placement
of solutions used in daily operations.

sumable inventory management > Supplies screen > Solutions
used in daily operations (i-series)
 Reaction vessels (500 RVs per bag)
 Sample cups
Sample cups are 1400 uL disposable containers that hold samples. Volume graduation marks
at 125 uL, 500 uL, and 1400 uL eliminate the need to pipette with precision.

sumables > Bulk solutions (i-series)
Verify the supply and waste inventory

• Demonstrate how to verify the supply and waste inventory. On the supply screen the operator
can view the following information:
 c-series
 Percentage of the bulk solutions
 Percentage of onboard solutions in the sample wash solution area
 Status of the liquid waste in the high-concentration waste bottle
 Status of the ICT module
 i-series
 Percentage of bulk solutions
 Status of the reaction vessel (RV) waste
 Status of RVs
• Application Specialist: Review instrument status that consumables can be loaded in.
Replace Bulk Solution and Update the Inventory

• Bulk solutions can be entered either by scanning in barcode on solution or by entering
information manually. If information is entered manually, or if the system sensors have not
identified that you have opened and closed the bulk solution door, you will have to verify on the
screen that the bottle has been replaced using the replace button.
• Explain that for bulk solutions that have an onboard stability claim, onboard stability tracking
occurs when the bottle is replaced and the software is updated. To achieve the maximum
usage of the bulk solution, do not replace the solution until the total percent of the remaining
solution is below the low alert setting.
• Application Specialist: To replace a NEW lot number of ICT Reference Solution, the instrument
status of the c-series processing module must be Stopped, Warming, or Idle and the bulk solution
status must be Empty. Perform quality control testing before assay processing.
• Application Specialist: Review that if the in-use bulk solution is expired, a drain and flush of the
reservoir will need to be performed. This procedure will be covered in another section.
• Application Specialist: If for some reason full bottle in door needs to be removed, do not put on
and take off more than 3 times. At this point it has been noted that the punctured seal can start
to leak.
• Application Specialist: If customer is using a high concentration waste container, when it is full,
the instrument will automatically go into stopped status and send all testing in progress to
exceptions.
Procedure Map Reference: Sample processing > Prepare for oper-

ation > Replenish the inventory and empty the waste > Consum-
able inventory management > Replace bulk solutions and update
the inventory
Replace sample onboard wash solutions and update the inventory Alinity c-series
• The onboard wash solutions to replace for a Alinity c-series are the:
 Acid Probe Wash
 Detergent A
• Point out that this procedure requires two 16 mm x 100 mm sample tubes and a measuring
device that can deliver up to10 mL. When the wash solution is replaced, use the measuring
device to dispense from 1 ml through 10 mL of the solution.
• Application Specialist: Review that operations manual procedure states that tubes must be
replaced daily and the instrument must be in an Idle status.

able inventory management > Replace sample onboard wash
solutions and update the inventory (Alinity c-series)
Remove the RV waste and update the inventory (Alinity i-series)

• Demonstrate the procedure either using the animations within the Operations Manual (Help) or
in front of the instrument, if the number of participants is small.
• The waste container can hold 1000 RVs (5 hours of run time at 200 RVs per hour).
• Once the waste container is removed, the system counts RVs. The waste chute holds 50 RVs
before the system operations is paused. The system will go into Stopped at 208 RVs.
Online Operations Manual (Help): Performance characteristics

and specifications > specifications and requirements > System
capacities > Processing module capacities (i-series)

able inventory management > Remove the RV waste and update
the inventory (Alinity i)
Replenish reaction vessels (RVs) and update the inventory (Alinity i-series)
• Demonstrate how to replenish RVs and update the inventory of an Alinity i-series.
• Demonstrate the procedure either using the graphics within the Operations Manual (Help) or in
front of the instrument, if the number of participants is small.

and specifications > specifications and requirements > System
capacities > Processing module capacities (i-series)

able inventory management > Replenish reaction vessels (RVs)
and update the inventory (Alinity i)
Activity 1: Identify the required consumables of the Alinity c-series
Purpose: To become proficient at identifying the required consumables of the Alinity c-series.
Application Specialist: Discuss onboard stability.
Actions: List the required consumables of the Alinity c-series.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Online Operations Manual (Help): Use or function >Processing

module (i-series) > Required consumables
Activity 2: Identify the required consumables of the Alinity i-series
Purpose: To become proficient at identifying the required consumables of the Alinity i-series.
Application Specialist: Discuss onboard stability.
Actions: List the required consumables.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Online Operations Manual (Help):Use or function > Processing

Module (i-series) > Required consumables
Activity 3: Verify the supply and waste inventory
Purpose: To become proficient at identifying the required consumables of the Alinity i-series.
Actions: Verify the supply and waste inventory. List the total remaining percentage for each
consumable.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

able inventory management > Verify the supply and waste
inventory
Activity 4: Replace required consumables
Purpose: To become proficient at replacing required consumables.

Actions: Replace and update any required consumables. List the consumables replaced.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

able inventory management > Replace bulk solutions and update
the inventory
Knowledge Check: Consumable Inventory

1. Select all of the following that are bulk solutions used on an Alinity i-series module.
a) Pre-Trigger solution
b) Trigger solution
c) Hydrogenated oil
d) Concentrated Wash Buffer
Answer:
2. True or false? Reaction vessels (RVs) can be added at any time as long as the inventory allows.
Answer:
3. What size tube does the sample onboard wash solutions use?
a) 16 mm x 100 mm
b) 30 mm x 120 mm
c) 3 mm x 20 mm
Answer:
Reagent carousel inventory management

• This lesson will provide you with basic knowledge about the reagents, reagent preparation,
reagent handling, and the required accessory for reagents for the Alinity ci-series.
• After completing this lesson, you should be able to:
 Identify the reagents used in the Alinity ci-series.
 Prepare reagents.
 Prepare onboard solutions and sample diluents.
 Identify the required accessory for reagents of the Alinity ci-series.
 Load cartridges into trays.
 Load trays into the Reagent and Sample Manager (RSM).
 Unload trays and cartridges from a reagent carousel to the RSM.
 Unload reagents from the Reagent and Sample Manager (RSM).
 View or print assay inserts.
• Reagent carousel inventory management includes procedures to prepare and replenish
reagents, onboard solutions, and diluents. You will use the Reagent screen to view and manage
in-use reagent carousel inventory.
• The facilitator will identify and describe reagent cartridges and demonstrate the loading and
unloading of reagents for the Alinity ci-series, including:
 Verify reagent carousel inventory.
 Prepare reagent cartridges.
 View or print assay inserts.
 Prepare onboard solutions and sample diluents (c-series).
 Print a 1D reagent bar code report (c-series)
 Required accessory.
 Descriptions of cartridge statuses.
 Descriptions of load statuses.
 Load reagent cartridges into trays.
 Load trays on the reagent and sample manager (RSM).
 Load cartridges on the reagent and sample manager (RSM).
 Unload reagent cartridges from the reagent carousel.
 Cancel a cartridge unload.
 Unload reagents from the reagent and sample manager (RSM).
Verify reagent carousel inventory

• Review Alinity ci-series processing module image and identify that the Reagent status button will
indicate if a supply is low.
 Green reagent is OK
 Yellow reagent is Low or Overriden
 Red reagent is empty or expired

screen > Home screen element descriptions
• The reagent carousel inventory includes:

 Reagents
 Onboard solutions
 Diluents (c-series for reagent carousel)
 Maintenance solutions
 Calibrators (c-series for reagent carousel)
 Controls
On-board vial racks will show up on the reagent carousel inventory screen as purple hexagon
shaped icons.
Pressing the reagent position icon (the number of the position where the reagent is located) on
the left hand side of the screen will highlight associated information on the right hand side of the
screen
Online Operations Manual (Help): Operating instructions> Reagent

and sample management> Reagent carousel inventory manage-
ment> Reagents screen> Verify the reagent carousel inventory
Descriptions of cartridge statuses

• The Alinity ci-series has the following cartridge statuses:
 BC Fail The bar code on a reagent carousel inventory item is not readable.
Note: This status is also displayed when the reagent carousel

cover is removed. When the instrument status of the
Reagent and Sample Manager (RSM) is Running, reagent
carousel items are removed from the reagent carousel, are
scanned, and are reloaded.
 Undefined The reagent configuration for a 1D reagent bar code is not defined.
 Load Error A hardware error occurred when a reagent cartridge was loaded and prevented
the loading of the cartridge in the reagent carousel.
 Incomplete A hardware error occurred when a two-cartridge reagent set was loaded or
unloaded, which caused the reagent cartridges to be separated.
Note: One of the following conditions can cause this status to

display:
- One reagent cartridge is located on the RSM and the
other cartridge is located in the reagent carousel.
- One reagent cartridge is located on the RSM or the
reagent carousel and the other cartridge is no longer stored
on the system.
 No Assay A reagent is not used by any assay file that is installed on the system.
 Empty A reagent carousel inventory item is empty.
 LLS Error Three consecutive liquid level sense or pressure monitor errors occurred during
aspiration of a reagent carousel inventory item.
 Expired A reagent inventory item is expired or has exceeded the onboard stability time.
 Disabled The operator or the system has disabled a reagent cartridge to prevent the
processing of patient samples.
 Low Alert The remaining volume of a reagent carousel inventory item is below the configured
number of tests for the low alert notification.
 Overridden The operator has overridden a reagent carousel inventory item that is expired or
has exceeded the onboard stability time.
 Mixing The reagent is mixing to disperse the microparticles.
Note: This status is not displayed for c-series reagents.
 OK A reagent carousel inventory item is okay.
Online Operations Manual (Help): Operating instructions >

Reagent and sample management > Reagent carousel inventory
management > Reagents screen > Descriptions of cartridge sta-
tuses
Descriptions of load statuses

• Load status information is used to determine the status of the loading and unloading of
cartridges and racks and to determine if loading problems or unloading problems have
occurred.
• The following list provides descriptions of the load statuses. The statuses are described in the
order in which they are sorted:
 Unload error: A cartridge or rack cannot be unloaded because one of the following
situations occurred:
 A hardware error occurs when the cartridge or rack is unloaded.

 A hardware condition prevents the unloading of cartridges or racks.
 The instrument status of the processing module transitions to Stopped while the cartridge
or rack is being unloaded.
 The instrument status of the Reagent and Sample Manager (RSM) transitions to Stopped or
Idle while the cartridge or rack is being unloaded.
 Load error: A hardware error occurred when a cartridge or rack was loaded, or a hardware
condition prevents the loading of cartridges or racks.
 Scheduled unload: A cartridge or rack needs to be unloaded from the reagent carousel, but
the cartridge or rack cannot be unloaded immediately because one of the following
situations occurred:
 Tests are in process for the cartridge or rack.

 No positions are available on the RSM for the cartridge or rack.
 The system is loading or unloading another cartridge or rack.
 Scheduled load: A cartridge or rack needs to be loaded in the reagent carousel, but the
cartridge or rack cannot be loaded immediately because one of the following situations
occurred:
 No positions are available in the reagent carousel for the cartridge or rack.
 The system is loading another cartridge or rack.
 Partially unloaded: The first cartridge of a two-cartridge reagent set has been unloaded into
the RSM, but the second cartridge cannot be unloaded into the RSM because no positions
are available.
 Scanning: The bar code reader has scanned the first cartridge of a two cartridge reagent set
and is waiting to scan the second cartridge.
 Unloading: A cartridge or rack is being unloaded from the reagent carousel. For a
two-cartridge reagent set, the load status remains as Unloading until both cartridges have
been unloaded.
 Loading A cartridge or rack is being loaded in the reagent carousel. For a two-cartridge
reagent set, the load status remains as Loading until both cartridges have been loaded.
 Blank: A status is not displayed for any of the following conditions:
 A cartridge or rack is loaded successfully in the reagent carousel.
 A cartridge or rack is unloaded successfully into the RSM.
 A cartridge or rack is loaded on the RSM but is not scanned by the bar code reader.
 Processing: An onboard vial rack has been removed from the reagent carousel for control
processing or calibration processing.

management > Reagents screen > Descriptions of load statuses
View or print an assay insert
• The facilitator will demonstrate, if connected to AbbottLink, how to view or print an assay insert
under the details screen of the reagent.
• If the system is not connected to AbbottLink, the assay inserts are available at
corelaboratory.abbott.com
Online Operations Manual (Help): Operating instructions>Reagent

and sample management > Reagent carousel inventory manage-
ment> Reagents screen > View or print assay inserts
Disabling and Enabling a reagent cartridge
• Demonstrate how to Patient disable and then enable a reagent cartridge

and sample management > Reagent carousel inventory manage-
ment> Reagents screen > Disable a reagent cartridge
Prepare Reagent Cartridges
• Describe the bottles within a reagent cartridge. Alinity c-series will always have 2 positions, i-series
will have 3. Positions will contain bottles or spacers, dependent upon how many will actually
contain reagent. Chemistry reagents will have a pink case and IA will have a green case.
• Explain that all i-series reagents must be mixed upon receipt. Mixing instruction graphics are
located on the reagent kit box and detailed instructions are provided in the assay
documentation.
• Explain that not all (c-series) reagents require mixing, and some i-series reagents require extra
mixing. Stress that reagent handling instructions and mixing instructions should be reviewed in the
assay documentation prior to performing the assay.
• Explain that the operator cannot observe bubbles in the black bottles, so i-series reagents after
being mixed upon receipt into the laboratory are stored for 1 hour prior to use to allow the
bubbles to dissipate.
• Explain that black bottles are used because some reagents are light sensitive.
• Review handling of reagents to prevent evaporation, contamination, and maintain reagent

integrity.
• Review that when removing reagents, replacement caps should be used.
• Application Specialist: Review that a reagent bottle that has a yellow cap requires special
preparation. For specific instructions for reagent handling, see the assay documentation.
• Important: For i-series reagent cartridges that have an integrated septum, during assay
processing, the reagent pipettor pierces the reagent cartridge septum. After the septum is
pierced, do not invert the cartridge since this action causes reagent leakage and may
compromise test results. Store pierced cartridges in an upright position.

ation > Replenish the inventory and empty the waste > Reagent
carousel inventory > Prepare reagent cartridges
Prepare onboard solutions

• Demonstrate preparing onboard solutions (Alinity c-series).
• Demonstrate the procedure using the animations inside the Operations Manual (Help) or with an
onboard solution cartridge.

carousel inventory > Prepare onboard solutions (c-series)
Prepare sample diluents and user-defined reagents (c-series)

• Demonstrate preparing sample diluents and user-defined reagents (c-series)
 There a two different types of c-series reagent cartridges, black and clear. The black
cartridges must be used for light-sensitive user-defined diluents and user-defined reagents.
 For the black cartridges, there are two list numbers 04S1720 and 04S1750. Clear cartridge list
number is 04S1740.
• Application Specialist: It is critical that reagent cartridges are not overfilled. This is critical
because liquid level sensing does not occur until after the reagent carousel has rotated. This
rotation occurs very quickly and if reagents are overfilled, spillage can occur. If spillage occurs,
significant instrument repairs may be needed. Per the Operations Manual, maximum fill volumes
are as follows:
 For black cartridge LN 04S1720 the maximum fill volumes are:
 R1 bottle, saline diluent: 74 mL
 R1 bottle, saline for use with the Sample Interference Indices Saline Protocol: 74 mL
 R1 bottle, user-defined diluent: 50 mL
 R1 bottle, user-defined reagent: 50 mL
 R2 bottle, user-defined reagent: 47 mL
Note: Since LN 04S1720 and LN 04S1750 are visually identical, if the cartridge list number cannot be
determined, use the fill volumes for LN 04S1720.
 For clear cartridge LN 04S1740 or black cartridge LN 04S1750:

 R1 bottle: 74 mL or to the maximum fill line (MAX)
 R2 bottle: 46 mL or to the maximum fill line (MAX)
Note: For all list numbers, the dead volume of the R1 bottle is 3ml and the dead volume of the R2
bottle is 2.6ml.
Online Operations Manual (Help): Operating Instructions>Reagent

and Sample Management> Reagent carousel inventory manage-
ment > Reagents screen > Prepare sample diluents and
user-defined reagents (c-series)
Print a 1D reagent bar code report (c-series)

• Explain that all reagent bottles loaded on the system require bar codes. The system can print
one-dimensional 1D bar code labels.
• Demonstrate how to print a one-dimensional 1D reagent bar code report (c-series).
• Identify the types of Avery labels that can be used. Review that labels should be water resistant if
possible
• Explain that the 1D bar code format encodes expiration dates by the week. If the entered
expiration date does not correspond to the end of a seven-day week, the expiration date for the
printed bar code is the end of the previous week.

and Sample Management>Reagent Carousel Inventory Manage-
ment>Reagents Screen > Reagent Cartridge details screen > Print
a 1D Reagent barcode report (c-series)

and specifications > Specifications and requirements >Bar code
label requirements>1D reagent bar code label requirements
(c-series)>1D reagent bar code label data format (c-series)
Required accessories (racks and trays)

• Racks are accessories that are used on the Reagent and Sample Manager to transport
specimens, calibrators, and controls to the sample pipettor. The Alinity ci-series uses three types
of racks.
 Vial rack: Bar-coded for identification with the letter V. Holds six open vials of calibrators or
controls for immediate use. The rack cannot be stored in the reagent carousel. Vial racks are
cream in color.
 Onboard vial rack: Bar-coded for identification with the letter U. Holds six vials of calibrators or
controls. The rack is stored in the reagent carousel. Each processing module can be
configured to hold up to four onboard vial racks. On a multi-module system, c-series products
in an on-board vial rack may be stored in the i-series module or vice-versa. On-board vial
racks are removed from the storage module and taken to the appropriate module for
sampling. Onboard vial racks have a yellow top cover.
 Application Specialist: Once calibrator or QC vials are scanned into an onboard vial rack, if
the vials are removed, they must be placed back into the same rack and positions in order to
be recognized.
• Sample rack: Bar-coded for identification. Holds six primary tubes, aliquot tubes, or sample cups.
Any combination of tubes and cups can be used in the rack. Sample racks are gray in color.
• Application Specialist: Review that racks and trays should be inspected for damage prior to use.
Online Operations Manual (Help): Use or function > Required

accessories > Trays
Load reagent cartridges into trays

• Demonstrate loading cartridges in trays.
.

carousel inventory > Load racks and cartridges into trays
Load trays on the Reagent and Sample Manager (RSM)

• Point out that before loading, the status indicators above the bay positions should not be
illuminated.
Procedure Map Reference: Sample processing > Load samples >

Load cartridges on the Reagent and Sample Manager (RSM)

• The RSM status must be Running for the cartridges to load into the reagent carousel.
• If a reagent cartridge is loaded, and a specific processing module is not specified, and more
than one module is eligible to accept the cartridge, the cartridge is loaded on the module with
the lowest usable, onboard total test count for the reagent.
• In order to load a reagent or onboard vial rack onto a specific processing module if more than
one processing module of the same type is configured for the system, on the left side of the
loading area of the specific processing module, press the priority button and load the cartridge
or vial rack onto the desired processing module.
• Application Specialist: Discuss error code when assay version is incorrect.
• Application Specialist: For products that have an onboard stability claim, onboard stability
tracking occurs after the cartridge is scanned by the barcode reader. After the cartridge is
unloaded from the reagent carousel and is removed from the RSM, the time for onboard stability
tracking stops.

carousel inventory > Load cartridges on the Reagent and Sample
Manager (RSM).
Unload reagent cartridges from the reagent carousel

• The Alinity ci-series automatically unloads items that have a cartridge status of Empty, Expired, or
LLS Error.
• Application Specialist: Review procedure for returning onboard material to storage in
refrigerator.
• The RSM status must be Running.
• To ensure correct tracking status, do not move the cartridges to a processing module that is
controlled by a different system control module.
• Multiple items can be selected and unloaded from the reagent carousel inventory that is
displayed for all modules on the Current tab. Only one item can be selected and unloaded from
the reagent carousel inventory that is displayed for the selected module.

carousel inventory > Unload reagents from the Reagent and Sam-
ple Manager (RSM)
Cancel a rack unload or a cartridge unload

• Demonstrate canceling a cartridge unload.

carousel inventory > Cancel a rack unload or a cartridge unload
Unload reagents from the Reagent and Sample Manager (RSM)

• Application Specialist: Review procedure for returning onboard material to storage in
refrigerator.

ation > Replenish inventory and empty the waste > Reagent car-
ousel inventory > Unload reagents from the Reagent and Sample
Manager (RSM)
Delete a reagent carousel item (CSC Logon)
The facilitator will demonstrate the steps to how to delete a reagent carousel item.

management > Reagents screen > Delete a reagent carousel
item (CSC Logon)
Activity 1: Verify reagent carousel inventory
Purpose: To become proficient at verifying reagent carousel inventory.

Actions: Verify the reagent inventory of the Alinity ci-series. Select an assay and record the
number of tests available for each reagent cartridge onboard.

ation > Check the inventory > Verify the reagent carousel inven-
tory
Activity 2: Load reagent cartridges into trays
Purpose: To become proficient at loading reagent cartridges into trays.

Actions: Prepare and load a reagent cartridge into a tray.

ation > Check the inventory > Verify the reagent carousel inven-
tory
Activity 3: Load trays on the Reagent and Sample Manager (RSM)
Purpose: To become proficient at loading trays on the Reagent and Sample Manager (RSM).
Actions: Load the tray onto the Reagent and Sample Manager (RSM).

carousel inventory > Load trays on the Reagent and Sample Man-
ager (RSM)
Activity 4: Unload reagent cartridges from a reagent carousel to the

Actions: Select a reagent cartridge and unload the reagent cartridge from the reagent
carousel.

carousel inventory > Unload racks and cartridges from a reagent
carousel to the RSM
Activity 5: Unload reagents from the Reagent and Sample Manager (RSM)
Purpose: To become proficient at unloading the Reagent and Sample Manager and storing the
reagents.
Actions: Unload the Reagent and Sample Manager and store the reagents.

management > Reagents screen > Unload reagents from a
Activity 6: View or print an assay insert
Purpose: To become proficient at identifying an assay and viewing or printing the assay insert.
Actions: Identify an assay and view or print the assay insert. This activity requires that the system is
connected to AbbbottLink. If the system is not connected to AbbottLink, the activity cannot be
performed.

management > Reagents screen > View or print assay inserts
Application Specialist Activity: Prepare and Load Saline as a Sample

diluent - c-series
Purpose: To become proficient at printing 1D barcode labels and filling reagent cartridges for
onboard diluents.
Actions: Prepare and load Saline as a barcoded sample diluent onto the Alinity c-series. Review
dating format.
Online Operations Manual (Help): Operating Instructions >

Reagent and Sample management > Reagent Carousel Inventory
Management > Reagents Screen > Prepare sample diluents and
user-defined reagents (c-series)
Review
1. True or false? If the inventory is not adequate when sample processing is initiated, tests become
exceptions and are not processed.
Answer:
2. Select all of the following items that a reagent carousel inventory may include:
a) Calibrators and controls
b) Onboard solutions
c) Extra water
d) Reagents
Answer:
3. Order the following steps in the correct sequence to verify the reagent carousel inventory.
a) To display one module, tap a Module button.
b) On the menu bar, tap Reagents to display the Current tab of the Reagents screen.
c) Verify the reagent carousel inventory.
Answer:
4. When should you verify the supply and waste inventory?

a) Before sample processing is initiated or when a status indicator is displayed.
b) After sample processing.
c) When you hear a beep.
d) You do not have to verify the supply and waste inventory in every single circumstance.
Answer:
5. True or false? When replenishing RVs, you can use the bar code scanner to scan the bar code on
the new bag.
Answer:
6. Select all of the following scenarios that alert you when you need to replace and update the
bulk solution inventory:
a) When the bottle has reached the onboard stability expiration date.
b) When a bottle is empty and the total percentage of the remaining solution is below the low
alert setting.
c) Never.
d) When a bottle has expired.
Answer:
7. Which one of the following functions can the operator perform on the Reagents screen?
a) Access reagent cartridge details
b) Update the inventory for bulk solutions
c) Verify the supply and waste inventory
d) Replenish RVs
Answer:
8. Select all of the following activities included in reagent management:

a) Manage reagent carousel inventory
b) Prepare, load and unload samples
c) Verify the supply and waste inventory
d) Initiate sample processing
Answer:
9. True or false? Empty trays may remain on the loading area to create five positions to load racks
or cartridges one at a time.
Answer:
Module 5: Reagent and Sample Manager (RSM)
Module 5: Reagent and Sample

Manager (RSM)
Objectives • Identify the primary components of the RSM

• Explain the meaning of RSM Status Indicators
• Identify Priority positions
Module Topics
Familiarizing yourself with the instrument is essential to ensuring that it performs appropriately.
• Primary components of the Reagent and Sample Manager (RSM)

• RSM Functions
• RSM Status Indicators

Note: A multimodule system includes multiple
processing modules in different combinations
of chemistry and immunoassay processing
modules.
The reagent and sample manager (RSM) is a transport system used to load calibrators, controls,
specimens, reagents, and onboard solutions.
The design of the RSM provides random and continuous access to load and unload sample racks,
calibration and control racks, and reagent cartridges.
One primary RSM transports samples and reagents through an Alinity ci-series regardless of the type
and number of processing modules.
Bays holds trays that are used to position racks and cartridges for assay processing.
Three status indicators are located above each reagent and sample manager (RSM) position to
indicate the status of sample processing and when racks and cartridges can be accessed.
• The RSM is composed of the:

 Loading area
 RSM transport
 RSM bar code reader
 Sample positioner

Loading area
• Loading area: Positions racks and cartridges for loading and unloading
• The facilitator will point out the loading area of the RSM.
• The loading area is composed of:
 Priority button: Temporarily assigns an RSM position as a priority position.
 Priority position: Designated with a blue status indicator. Racks or cartridges inserted in this
position are processed before other positions.
 Status indicators: Indicates the status of sample processing and when samples and reagents
can be accessed.
 Tray: Holds racks and cartridges to load on the Reagent and Sample Manager (RSM). Each
tray holds a maximum of five racks or cartridges. Empty trays may remain on the loading area
to create five positions to load racks or cartridges one at a time.
 Position: Holds one rack or cartridge. Each processing module has 25 positions.
 Bay: Holds trays that are used to position racks and cartridges for assay processing. Each
processing module contains five bays.
Online Operations Manual (Help): Use or function> Alinity ci-series

hardware overview> Primary components of Alinity ci-series>
Reagent and Sample Manager (RSM)> Loading area
RSM transport
 Identify the location of the RSM transport.
 Transports racks and cartridges from the loading area to be read by the bar code reader
and to be placed on the module-specific sample positioner or reagent positioner.

RSM bar code reader
• The RSM barcode reader is an imaging camera that reads bar code labels on samples, racks,
and cartridges.
• Identify the location of the RSM bar code reader.

Sample Positioner
• Positions racks at the sample aspiration position. Each module has two sample positioners. A rack
exchange occurs between the loading area and one sample positioner while the other sample
positioner positions samples for aspiration.

Status Indicators
• Three status indicators (blue, green, and amber) are located above each reagent and sample
manager (RSM) position to indicate the status of sample processing and when racks and
cartridges can be accessed.
• The status indicators of the RSM are:
 Indicators off: No rack or cartridge is inserted in the position.
 Green (steady): The rack or cartridge is inserted but is not in process. The rack or cartridge
can be accessed.
 Amber (steady): The rack or cartridge is in process. The rack or cartridge cannot be
accessed.
 Green (blinking): Processing is completed. The rack or cartridge can be accessed.
 If a test is added or a rerun is scheduled before the rack is removed from the loading
area, the status indicator for the position changes to amber and the rack cannot be
accessed.
 Amber (blinking): Unloading of a cartridge or on-board vial rack is in process. The position is
reserved and is unavailable to load a rack or cartridge.
 Amber and green (alternating): A bar code scan error or other error occurred. The rack or
cartridge can be accessed.
 Blue: The RSM position is designated as a priority position.

Reagent and Sample Manager (RSM) > Status indicators
Demonstration: Creating a temporary priority position
Purpose: To be familiar with process of creating a temporary priority

position on the RSM.
Actions: Perform this procedure to temporarily assign a Reagent and
Sample Manager (RSM) position as a priority position if no priority
positions are configured or if additional priority positions are required.
Priority positions are designated with a blue status indicator above the
bay position.
1. On the left side of the loading area of a processing module, press the
priority button.
2. The Priority button illuminates when pressed.
3. Insert a rack, cartridge, or tray into any position on the loading area of
the specific processing module.
4. If a rack is inserted into a position, the system designates the position as
a priority position.
If a tray is inserted into a position, all positions of the tray with carriers
loaded are designated as priority positions. When the rack is removed,
the blue status indicator for the priority position is not illuminated.
Note: After the priority button is pressed, the rack, cartridge, or

tray must be inserted into a position within 10 seconds. To deacti-
vate the RSM priority button before the time-out expires, press the
priority button again.
Note: On a multimodule system the priority button can be used to
force load a reagent onto a specific module. If the priority button
is illuminated and a reagent is loaded, the reagent will then be
loaded into that specific reagent carousel

Reagent and sample management > Assign a temporary priority
position to load racks and cartridges
Reagent and sample manager (RSM) processing priorities
After a rack or cartridge is loaded on the RSM, the RSM transport moves the rack or cartridge to or
from a processing module location. The RSM transport performs the processing priorities in a specific
order.

Reagent and sample management > Sample management >
Sample Processing > Reagent and sample manager (RSM) pro-
cessing priorities
Activity 1: Identify RSM components
Purpose: To become proficient at identifying the Reagent and Sample Manager (RSM)
components.
Actions: Perform the activity in the appendix by labeling the components of the RSM.

Activity 2: Identify the RSM Loading area components
Actions: Match the Reagent and Sample Manager (RSM) loading area components with their
definition.
RSM loading area Definition

component
___ A - Bay 1. A position on the RSM designated with a
blue status indicator. Racks or cartridges
inserted in this position are processed
before other positions.
___ B - Tray 2. Allows the operator to temporarily assign

an RSM position as a priority position.
___ C - Position 3. Accessories used to hold racks and

cartridges for loading on the RSM. Each
tray holds up to five racks or cartridges.
___ D - Priority section 4. One section of a tray. Empty trays may be

left on the load platform to create five
positions to allow for loading single racks
or cartridges at a time. Each processing
module has 25 positions.
___ E - Priority button 5. A holding area that holds trays used for
positioning racks and cartridges for assay
processing. Each processing module
contains five bays.
___ F - Status indicators 6. Indicates the status of sample processing

and when samples and reagents can be
accessed.

Reagent and Sample Manager (RSM) > Loading area
Activity 3: Identify the meaning of the RSM status indicators
Purpose: To become proficient at identifying the Alinity ci-series RSM Loading components.
Actions: Match the indicator with the status.
Status Indicator Status

___A - Indicators off 1. The rack or cartridge is processing. The
rack or cartridge cannot be accessed.
___B - Green (steady) 2. The rack or cartridge is inserted, but

processing has not begun. The rack or
___C - Amber (steady) 3. Unloading of a reagent cartridge is in

process so the position is reserved and
unavailable for loading a rack or
cartridge.
___D - Green (blinking) 4. Processing is complete and the rack or

___E - Amber (blinking) 5. No rack or cartridge is inserted in that

position.
___F - Amber and green 6. The RSM position is designated as a priority

(blinking) position.
___G -Blue 7. A barcode scan error or other error

occurred. The rack of cartridge can be
accessed.
Review
1. Which one of the following is the transport system used to load calibrators, controls, specimens,
reagents, and onboard solutions?
a) Transport System (TS)
b) Specimen and Reagent Mover (SRM)
c) Reagent and Sample Manager (RSM)
Answer:
2. True or False? Status indicators are located above each bay position of the Reagent and
Sample Manager.
Answer:
3. True or False? All Alinity ci-series are composed of a System Control Module (SCM), an RSM, and
a processing module.
Answer:
4. True or False? A blue status indicator indicates a priority position on the RSM.
Answer:
5. True or False? Cartridges and vial racks are loaded on the RSM and transferred to the reagent
positioner by the RSM transport.
Answer:
Module 6: Daily Maintenance
\
Objectives • View Maintenance procedures

• Identify consumables used in Daily Maintenance
• Perform Daily Maintenance
Module Topics
A thorough maintenance program minimizes downtime, maintains records for inspection and
accreditation, and maintains system performance to provide optimal test results.
In this module, you will explore performing daily maintenance.
Online Operations Manual (Help): Section 9 Service, Maintenance

and diagnostics subsections; Maintenance and diagnostics, Pro-
cedures Log screen and Maintenance procedure descriptions
Maintenance Overview
Maintenance can be performed on a daily, weekly, monthly, triannual, quarterly, semi-yearly, or
as-needed basis. Maintenance can also be performed yearly, currently there are no Abbott
defined procedures that meet this requirement.
Use the procedure key to perform a procedure
Describe the procedure key settings:

 Off - This setting is indicated by the black dot on the procedure lock. To perform a procedure,
the procedure key is not required to be inserted into the procedure lock.
 Required On - This setting is indicated by the white dot on the procedure lock. To perform a
procedure, the procedure key must be inserted into the procedure lock and must be
positioned at the On setting.
 Optional On - The procedure key is or is not inserted into the procedure lock. If the procedure
key is inserted, the key can be positioned at the setting for On or Off. However, access to the
front and rear processing center covers is permitted only when the procedure key is inserted
and is positioned at the On setting.
 For procedures that require a processing module and the RSM, the procedure keys for the
processing module and the system control module (SCM) need to be positioned at the
designated procedure key settings.
 Application Specialist: Setting information can be found on the Procedure Details flyout for
each maintenance and diagnostic procedure.
 Application Specialist: Customers should be trained that procedure key should not be stored
in the lock, but should be stored away from the instrument.
 Application Specialist: Review what message code will be generated if you attempt to put
system into running while procedure key is in on position. The system will not go into a running
status if the procedure key is in the On position.
Note: Access to the front and rear processing center covers is

permitted only when the procedure key is inserted and is
positioned at the On setting. If the front or rear processing
center cover is lifted during the procedure when the
procedure key is positioned at the Off setting or when the key is
not inserted, the instrument statuses of the processing module
and the RSM transition to Stopped and power is removed from
the following module components:
 c-series: Sample pipettor
 i-series: Sample, R1, and R2 pipettors
 RSM: RSM transport
Online Operations Manual (Help):Service, maintenance, and

diagnostics > Maintenance and diagnostics > procedures screen
> descriptions of procedure key settings
Review performing a maintenance procedure

• Review the procedure map.
• The Procedures screen displays the maintenance procedures. After initiating a procedure, follow
the step-by-step instructions on the screen. Review how to perform a maintenance procedure
including:
 Returning to a maintenance procedure in process.
 Adding a comment to a maintenance procedure.
• Review the procedure key setting and that the key setting for each procedure can be found in
the Procedure Details flyout.
• Review that maintenance procedures contain videos and graphics.
 The Show Video button and Show Picture button will display when pictures and videos are
available.
 As an alternative to demonstrating the procedure in the following lessons, the operator can
view the videos during the activities.
• Point out that maintenance procedures may expose the operator to potentially hazardous
conditions. Untrained operators must not perform these procedures.
• Point out that each procedure has a a list of supplies needed for that procedure located in the
Operations Manual (Help) or the first page of the procedure.
• Identify that the In Process tab of the Procedures screen displays procedures in process.
Procedure Map Reference: Maintenance > Perform maintenance

> Perform a maintenance procedure or a diagnostic procedure
Daily Maintenance
Materials needed for daily maintenance
Alinity c-series:
 Alinity c-series Maintenance Solutions
 Detergent A
 Acid Probe Wash
 Purified water (required only for systems running whole blood applications)
 Cotton swabs (required only for systems running whole blood applications)
Alinity i-series:
 Maintenance Cleaning Cartridge
 0.5% sodium hypochlorite
 Measuring device that can deliver 25 mL
 Probe Conditioning Solution, (loaded onboard in the reagent carousel)
Preparing the Alinity ci-series before processing specimens will help you maximize the workflow in
your laboratory.
Identify, describe, and demonstrate how to prepare your system for specimen processing which
includes:
 Use the procedure key to perform a procedure.
 Perform daily maintenance.
The daily maintenance procedure for the Alinity c-series is:

 5501 Daily Maintenance (Alinity c-series)
Demonstration: Perform daily maintenance (Alinity c-series)
• The procedure in the Operations Manual (Help) is a general

procedure on how to perform all maintenance and diagnostic
procedures. Detailed instructions are included with each
individual procedure.
• Materials needed:
 Alinity c-series Maintenance Solutions, LN 8P98
 Purified water (required only for systems running whole
blood applications)
 Cotton swabs (required only for systems running whole
blood applications)
 Detergent A, Acid Probe Wash and c-series maintenance
solutions need to be loaded into the reagent carousel prior
to daily maintenance being started
• Explain that the procedure in the Operations manual (Help) is a
general procedure on how to perform all maintenance and
diagnostic procedures. Detailed instructions are included with
each individual procedure.
Demonstration: Perform daily maintenance (Alinity c-series)
• Explain that the Alinity c maintenance solutions are supplied as a

three-component kit and are used during the automated daily
maintenance procedure. The large bottle of the maintenance
cartridge is filled with Water Bath Additive, an antimicrobial solution
used to reduce microbial contamination in the water bath. During
maintenance, the solution is dispensed into the water bath. The small
bottle is empty and is reserved for prepared Cleaning Solution. The
Cleaning Solution is supplied as a lyophilized material with a diluent.
The reconstituted cleaning solution is added to the small bottle. During
daily maintenance, the cleaning solution is used to clean. Once
reconstituted, the maintenance solution has a total of 12 uses and is
stable for 14 days. The sample and reagent probes, mixers, ICT Probe,
and ICT Module.
• Review that maintenance solution cartridges are blue in color.
• Explain that many procedures contain videos and graphics. The Show
Video button and Show Picture button will display when pictures and
videos are available.
• Explain that the procedure key setting for daily maintenance is
Required On. The procedure key must be in the On position to perform
this procedure.
• Demonstrate how to start Daily Maintenance, and then tap Quit at the
first screen to exit the procedure. Tapping Quit on this screen will not
change the module status to Stopped. Tapping Quit on any other
screen will stop the module.
• Explain that they can leave a maintenance or diagnostic procedure
while it is running to perform other activities in the software.
• Inform that if a procedure requires a response, the In Process tab is
displayed. If the tab is not displayed, tap the In Process tab.
• Review that the instructions for daily maintenance do not instruct
learner to change out Sample Wash solutions, but this should be
performed every 24 hours.
Online Operations Manual (Help): Use or function > required con-

sumables> maintenance solutions (c-series)
Online Operations Manual (Help): Service, maintenance, and

diagnostics > Maintenance and diagnostics > Maintenance pro-
cedure descriptions > Processing module maintenance proce-
dures (c-series)> Daily maintenance procedures (Alinity c) > 5501
Daily Maintenance (Alinity c)
• The daily maintenance procedure for the Alinity i-series is:

 2500 Daily Maintenance (Alinity i-series)
Demonstration: Perform daily maintenance i-series
The facilitator will demonstrate the procedure on the instrument software.

Supplies needed:
 Maintenance Cleaning Cartridge
 0.5% sodium hypochlorite
Note: The prepared solution is stable for 30 days.
 Measuring device that can deliver 25 mL

 Probe Conditioning Solution loaded in the reagent carousel
prior to performing daily maintenance
 Probe conditioning solution is a solution that contains recalcified
human plasma. Some maintenance procedures require this
solution after the sample pipettor probe is cleaned to condition the
probe to prevent the nonspecific binding of analytes in the probe.
This solution is stored at a temperature of 2°C to 8°C and is stable
on the system for 52 days or 48 tests, whichever occurs first.
Demonstration: Perform daily maintenance i-series (continued)
 Perform this Daily maintenance procedure to complete the

following tasks:
 Clean and condition the sample pipettor probe.
 Clean wash zone 1 probes and wash zone 2 probes with 0.5%
sodium hypochlorite solution.
 Flush and prime the Pre-Trigger Solution and the Trigger Solution.
 Explain that many procedures contain videos and graphics. The
Show Video button and Show Picture button will display when
pictures and videos are available.
 Explain that the procedure key setting for daily maintenance is
Optional On.
 Demonstrate how to start Daily Maintenance and then tap Quit at
the first screen to exit the procedure. Tapping Quit on this screen
will not change the module status to Stop. Tapping Quit on any
other screen will stop the module.
 Explain that they can leave a maintenance or diagnostic
procedure while it is running to perform other activities in the
software.
 Inform the participants that if a procedure requires a response, the
In Process tab is displayed. If the tab is not displayed, tap the In
Process tab.
 Inform the participants that more information on maintenance will
be provided in another lesson.
 The maintenance procedure confirms that a flush has been
performed in the last 8 hours, if not, it will perform one.
 i-series estimated time is 23 minutes, but may require an additional
5 to 25 minutes if a bulk solution transfer is necessary

dures (i-series) > Daily maintenance procedures (i-series) > 2500
Daily Maintenance (i-series)
Activity 1: Perform Daily Maintenance Procedures (Alinity c-series)
Purpose: To become proficient at performing Alinity c-series Daily Maintenance

Actions: Perform daily maintenance procedures as directed by instructor.
Activity 2: Perform Daily Maintenance Procedures (Alinity i-series)
Purpose: To become proficient at performing Alinity i-series Daily Maintenance

Actions: Perform daily maintenance procedures as directed by instructor.
Review
1. Daily maintenance procedures are required on the c-series and i-series processing modules.
a) True
b) False
Answer:
2. When the procedure key on the Alinity c processing module, the Alinity i processing module, and
the system control module (SCM) is positioned at the black dot is ON.
c) True
d) False
Answer:
Module 7: Calibrations
Objectives • Explain the need for calibrations

• Identify Calibration Types
• Describe Calibration Sample Processing Rules
• Describe the Calibration Status Details screen
• Fail a calibration
• Create a calibration order
• Describe the Orders and Order Details screen
• Prepare and load vials into vial racks for immediate use
• Initiate a calibration run
• View calibration status and history
• Archive calibration results
Module Topics
The Alinity ci-series offers highly automated calibration management.

• Calibration Guidelines
• Processing Calibration Samples
• Calibration Statuses
• Calibration Results
Calibration Guidelines
Calibration is the process used to analyze calibrators of a known concentration, record system
response values, and plot measured values against the known concentration.
An active calibration curve must be generated after an assay is installed.
Recalibration of an assay is not required every time they are run; however, certain variables
make recalibration necessary.
Mandatory assay calibration must be performed when:

 A new reagent lot number is used.
 Assay documentation states that a calibration is required when a reagent cartridge is
changed.
 Documentation that accompanies a new version of an existing assay file states that a
calibration is required.
 A new assay file that requires a calibration is installed.
 The calibration has expired.
Optional assay calibration may need to be performed when:
 Assay control values do not meet required specifications. For specific information about
quality control, see the manufacturer's documentation.
 Certain system maintenance procedures or component replacement procedures are
performed.
 Certain errors occur. To determine whether a recalibration is required when an error occurs,
see assay-specific message codes.
Online Operations Manual (Help): Calibration procedures > Cali-

bration guidelines
Calibration Types and Methods

After completing this section, you should be able to describe the calibration types and methods.
Description
This lesson will provide you with information regarding calibration guidelines, calibration types and
methods, and calibration curve storage.
Demonstration: Types and methods of calibration
The facilitator will review calibration including:

• Calibration method (c-series potentiometric).
• Calibration types and methods (c-series photometric).
• Calibration types and methods (i-series).
• Duration for this Show, approximately 20 minutes.
Calibration method (c-series potentiometric)

• Provide an overview of the calibration method (c-series potentiometric).
• For advanced training, provide in-depth information about:
 Electromotive force measurement (c-series potentiometric).
 Slope calculation (c-series potentiometric).
 Sample measurement (c-series potentiometric).
Online Operations Manual (Help): Calibration procedures >

Calibration types and methods > Calibration method (c-series)
potentiometric.
Calibration types and methods (c-series photometric)

• Provide an overview of the calibration types and methods (c-series photometric).
 Full calibration (c-series photometric):
 Absorbance method (c-series photometric).
 Factor method (c-series photometric).
 Linear method (c-series photometric).
 Logit-4 method (c-series photometric).
 Spline method (c-series photometric).
• Use factor and blank method (c-series photometric).

 Adjustment calibration (c-series photometric):
 Blank adjustment (c-series photometric).

Calibration types and methods > Calibration types and methods
(c-series photometric)
Calibration types and methods (i-series)

• Provide an overview of the calibration types and methods (i-series).
 Full calibration (i-series):
 Point-to-point method (i-series).
 Linear regression method (i-series).
 4PLC methods (i-series).
 Adjustment calibration (i-series):
 Ratio technique methods (i-series).
 Linear transformation method (i-series).
 4PLC methods (i-series).
• Curve shape methods (i-series).

 Index calibration (i-series):
 Cutoff assay method (i-series).
 Reference method (i-series).

bration types and methods > Calibration types and methods
(i-series).
Activity 1: Calibration method (c-series potentiometric)
Actions: Describe the calibration method for the c-series potentiometric assays.

Calibration types and methods > Calibration method (c-series
potentiometric).
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 2: Calibration types (c-series photometric)
Actions: Identify the calibration types for the c-series photometric assays.
Procedure Map Reference:

Calibration procedures > Calibration types and methods > Cali-
bration types and methods (c-series photometric)
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 3: Calibration types (i-series)
Actions: Identify the calibration types i-series assays.

Calibration types and methods > Calibration types and methods
(i-series).
________________________________________________________________________
________________________________________________________________________
________________________________________________________________________
Review Calibration Statuses

The facilitator will demonstrate how to view the calibration status
Online Operations Manual (Help): Operating instructions>Home

Screen>Home screen element descriptions

ation > View the assay calibration status > View the assay calibra-
tion status
 The calibration statuses are:

 Failed
 Expired
 No Cal
 Pending QC. A calibration that has a status of Pending QC is considered to be an active
calibration that cannot be used to process tests until one level of quality control is
completed.
 Overridden
 Overridden Lot
 In Process
 Active
 Inactive (historical)

bration review > Descriptions of calibration statuses
• Application specialist: Alinity instruments ship with the option to set an Assay Calibration Interval
setting that applies to all assays. The default for this is 30 days. This can be changed by the
customer, however, they should follow the recommended instructions in the reagent package
inserts under calibration.
• Note that calibration intervals set in the assays file take precedence over the system setting.
Most chemistry assays have a cal interval defined in the assay settings so the system setting
would not apply. On a standalone c-series instrument, this setting will not be available in the
software.
Online Operations Manual (Help): Installation procedures and spe-

cial requirements > System configuration > Configure Screen, Gen-
eral tab > Reagents and Supplies screen> Reagents and Supplies,
Reagents/Diluents tab element descriptions
Description of the Calibration Status Details screen

• Review the two items the operator can view:
 Details for calibrations
 Calibration graphs only for c-series
Review previous cal curve data (colors of lines for previous and current curve) and fit
concentration.

bration review > Calibration Status screen > Calibration Status
Details screen
Demonstration: Fail a calibration

 The facilitator will demonstrate how to fail a calibration curve.
Calibrations can only be failed if the processing modules are in
Stopped, Warming or Idle and the RSM is in Stopped or Idle.
Procedure Map Reference: Calibration > Calibration review > Fail a

calibration
Activity 1: View calibration results in the Calibration Status screen
Purpose: To become proficient at viewing calibration results in the Calibration Status screen.
Actions: View the calibration results previously generated in the Calibration Status screen.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Calibration procedures > Calibration

review > Calibration Status screen
Activity 2: View calibration details in the Calibration Status Details screen
Purpose: To become proficient at viewing calibration details in the Calibration Status Details
screen.
Actions: In the Calibration Status Details screen, view the details of the calibration results
previously generated.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Calibration procedures > Calibration

review > Calibration Status screen > Calibration Status Details
screen
Activity 3: Fail a calibration
Purpose: To become proficient at failing a calibration.
Actions: Fail a calibration.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Calibration > Calibration review > Fail a

calibration
Calibration Sample Processing

• Explain that when multiple reagent lots for an assay are loaded on the system (before the
sampling process for a calibration order begins), the system determines which lots to calibrate
using the calibration status of the reagent lot.
• The system also determines which lots to calibrate using the selected order options for the
reagent and module.
• Explain that for c-series photometric assays that are configured to perform calibrations by
cartridge, the reagent lot is comprised of the reagent lot number and the reagent cartridge
serial number. This combination of the two numbers is evaluated for calibration processing. The
calibration by cartridge option is unavailable for i-series assays.
• Explain that the Module Reagent Selection option is only available in multimodule systems with
redundant processing modules of the same type.
• The following rules are used by the system to determine which lots to calibrate using the
calibration status of the reagent lot, and the selected order options for the reagent and module.
If the Reagent Selection option is Auto, then for each selected

module with an instrument status of Running or Processing at the
time the calibrator samples are scanned
 The system calibrates all reagent lots loaded on the system
when no reagent lots for the assay have a calibration status
of Active or Pending QC.
when all reagent lots for the assay have a calibration status
 The system calibrates only the reagent lots loaded on the
system that do not have a calibration status of Active or
Pending QC, when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do
not.
If the Reagent Selection option is Module, then for each selected
module with an instrument status of Running or Processing at the
time the calibrator samples are scanned:
when no reagent lots for the assay have a calibration status
when all reagent lots for the assay have a calibration status
 The system calibrates only the reagent lots loaded on the
system that do not have a calibration status of Active or
Pending QC, when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do
not.
 The Module option is available only for multimodule systems
that have more than one module of the same type.

Reagent and sample management > Sample management
>Sample processing > Calibration sample processing
Create a Manual Calibration Order
Review the Create a calibration order procedure.

• Review that the default master lot for a calibrator set is displayed with the assay name. The
default master lot number for a blank calibrator set is listed after the calibrators set master lot
number for c-series assays that use a blank calibrator set. The assay name and calibrator master
lot number are displayed in red text if the calibrator master lot number is expired. Lot numbers
are not displayed for c-series assays that use the factor data reduction method.
• The rack ID and position are not required if the calibration used bar-coded sample, the
calibration uses only water, or the calibrator product is loaded in the reagent carousel.
Procedure Map Reference: Calibration > Order tests > Calibration

orders > Create a calibration order
Prepare and load vials into vial racks for immediate use
Review how to prepare and load vials into vials racks for immediate use.Vial racks are processed
as priority racks regardless of the position of the rack on the loading area of the RSM. If the
calibrators are in vials, a manual order is not required.

Onboard storage criteria for calibrator and control vials
Onboard vial racks that contain bar-coded calibrator and control vials are loaded in the reagent
carousel for onboard storage if the following criteria are met. Vials that are ineligible for onboard
storage can be processed in a vial rack or can be pipetted into sample cups and processed in a
sample rack.
1. All vials that are needed for a complete calibrator set are loaded in the onboard vial rack.
2. Each vial in a calibrator set has the same lot number and the lot number is configured as the
default.
3. Each calibrator set is configured as stored in the reagent carousel.
4. Each control vial is configured as stored in the reagent carousel.
5. A position in the reagent carousel is configured for the onboard storage of an onboard vial rack
and is available to receive the rack.
6. All vials have at least 48 hours before the lot expiration and onboard stability expiration are
exceeded. A status of Overridden does not meet this criteria.
7. All calibrator vials have a vial status of OK. No control vials have a vial status of Expired, Low Alert,
or Empty.
8. None of the vials have been processed previously in a different onboard vial rack.
9. The bar code label of each vial in a rack matches the lot number of a configured calibrator or
control.
Online Operations Manual (Help):Operating instructions > reagent

and sample management > reagent carousel inventory manage-
ment > sample management > sample processing > onboard stor-
age criteria for calibrator and control vials
Automated Calibration Ordering
Automated calibration orders are evaluated:

• When a barcoded calibrator vial is loaded on the RSM
• When the system software periodically evaluates calibrator vials stored in on-board vial racks
loaded in the reagent carousel
 This evaluation occurs every 15 minutes that a processing module is in a processing status or
when the instrument status transitions from Idle to Running or Idle to Processing.
The scanned barcode is compared to the configured calibrator set, if an order is present in the
system software that order is completed. If no calibration order is present in the system software and
the calibrator vial meets the criteria to create an automated order, the system automatically
creates and process the order.
Note: For c-series assays that are used for full and adjustment calibrations, calibrator vials are
evaluated first for the full calibration. If orders are not created for the full calibration, the
adjustment calibration is evaluated.
An automated order is generated if one of the following criteria is met:
• No active or overridden calibration curve is present for the assay
• If an active calibration curve exists, but will expire within 1 hour if calibrators are stored on the
reagent supply center or within 8 hours for all other calibrations
• For single analyte calibrators if all lots have a status of active or overridden and no calibrations
are in process
Note: This only applies if a barcoded calibrator vial is introduced into the RSM, this single analyte
calibrator rule does not apply when the 15 minute evaluator occurs for calibrators stored in
on-board racks in the reagent carousel
• The calibrator is in an onboard vial rack and a calibration that has a status of Active is present,
but the calibration will expire before the onboard vial rack is evaluated again and not
calibrations are in process.
• The assay is a c-series assay that used the factor data reduction method, and the calibration is
expired or will expire before the next evaluation interval
Automated calibration orders are not created in the following instances:
• A calibration order for the same assay is present
• The reagent cartridge status is Disabled
• The vial status of any calibrator vial is n the calibrator set is Empty, Expired, or LLS Error
• Assays that have an assay status of Correlation are present
Online Operations Manual (Help): Operating instructions > speci-

men, calibration and control orders > automated ordering > auto-
mated calibration ordering
Prepare and load vials into vial racks for onboard storage
Onboard stability tracking occurs when the software schedules the rack to be loaded on the
system. The onboard stability tracking of calibrators and controls continues when the rack is
unloaded. If the calibrators or controls meet the criteria for automated orders when the calibrators
or controls are scanned by the RSM bar code reader, and the instrument status of the processing
modules is Running or Processing, the orders are completed before the onboard vial rack is loaded
in the reagent carousel.
System capacities
• Calibrations:
 Active
 1 active calibration for a maximum of 4 different reagent lots for each assay on a
processing module. or four different reagent lots and cartridge combinations. When a fifth
reagent lot or a fifth reagent lot and cartridge combination is calibrated successfully, the
system replaced the oldest active calibration and the status of the calibration changes to
Inactive.
 Inactive
 Maximum of 3 months
 All calibrations are deleted from the system when the last cartridge of a reagent master
lot is deleted. The system deletes reagents when the reagent cartridge storage capacity
is exceeded. In addition, reagents are deleted when c-series user-defined assays are
deleted manually.
 Failed
 The system stores a failed calibration until an active calibration or another failed
calibration is generated for the reagent lot, or the reagent lot and cartridge combination,
that is specific to a processing module
Online Operations Manual (Help): Specifications and require-

ments> System capacities> Software data storage capacities

bration storage
Activity 1: Determine the assay calibration status
Online Operations Manual (Help): Specifications and require-

ments> System capacities> Software data storage capacities
Purpose: To become proficient at determining the assay calibration status.
Actions: View the assay calibration status for each reagent on the system. Note any calibration
that will fail in the next 8 hours.

ation > View the assay calibration status > View the assay calibra-
tion status
Activity 2: Create a calibration order
Purpose: To become proficient at creating manual calibration orders.

Actions: Create a calibration order of all assays that are going to expire, or select any other
assay with reagent onboard. Create at least one calibration order where the calibrators are not
onboard.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Calibration > Order tests > Calibration

orders > Create a calibration order
Activity 3: Prepare and load vials into vial racks for immediate use
Purpose: To become proficient at loading vials into racks for immediate use.
Actions: Load vials into vial racks for immediate use.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 4: Load racks on the Reagent and Sample Manager (RSM)
Purpose: To become proficient at Initiating or resuming sample processing.

Actions: Initiate or resume sample processing.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Load racks on the Reagent and Sample Manager (RSM)
Activity 5: Initiate or resume sample processing

_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Sample processing > Initiate sample

processing > Initiate or resume sample processing
Activity 6: Unload vials from the Reagent and Sample Manager (RSM)
Purpose: To become proficient at unloading vials from the Reagent and Sample Manager (RSM).
Actions: Unload vials from the Reagent and Sample Manager (RSM).
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Sample processing > Unload samples >

Unload vials from the Reagent and Sample Manager (RSM)
Knowledge Check: Processing Calibration

1. Select all of the following functions the operator can perform on the Calibration Status screen:
a) Search for specific calibrations based on specified search criteria.
b) Calculate slope.
c) Access calibration details.
d) Fail a calibration.
e) Print a calibration report.
f) Inspect cables that connect to the system for signs of wear and damage.
Answer:
2. True or false? The first step in creating a calibration order is tapping Orders on the Menu bar.
Answer:
Calibration Results
 Application Specialist: Review calibration tolerance limits as optional configuration for Alinity
c System only.
 Application Specialist: Point out that QC must be run after every calibration.
• After calibrators are processed, the system verifies the results by comparing them to the
calibration parameters and calibration validity checks that are specific to an assay.
• If the results of a calibration fall within the specified range for the assay, the new calibration
replaces any previous calibration and the status of the previous calibration changes to Inactive.
• If the results of a calibration fall outside the specified range for the assay, the status of the new
calibration is Failed.
 If the assay has an existing calibration, the calibration is not replaced.

• Remind how to view the calibration status.
• Review that calibration status can be viewed from the Home Screen.
 Green calibration is OK
 Yellow calibration will expire in one hour
 Red calibration is expired or failed.
Calibration History and Archive
Calibration History Tab
On the Calibration Status screen, the Historical tab displays all calibration information on the system
for up to 3 months. Inactive Status calibration curves are displayed only on the Historical tab of the
Calibration Status screen.
Archive Calibrations
The Alinity ci-series has a procedure to archive active and inactive calibrations, controls, or
specimen results to a USB flash drive.
The results are archived in an Excel file format and can be imported into a spreadsheet. The
archived results cannot be viewed on the Alinity ci-series. The USB is inserted into a USB port located
behind the system control module (SCM) front door.
For calibration results the procedure is performed from the Historical tab of the Calibration Status
screen.
• Select one or more calibration results.
• Select the Archive function button to display the Archive flyout.
• From the Archive flyout select the Archive Options and Archive
There are three Archive Options:
• All items: This option archives all calibrations within a defined date range.
• Incremental: This option archives all calibrations that do not have a status of Archived within a
defined date range.
• Selected items: This option is available only if calibrations were selected.
There are two Archive Mode Options:
• Only Archive: This option saves archived calibrations to a USB flash drive.
• Archive & Delete: This option deletes inactive calibrations after all the selected calibrations have
been archived to a USB flash drive.
Online Operations Manual (Help): Operating instructions > Archive

flyout> Archive the results
Review
1. Select all of the following instrument statuses where you can fail a calibration.
a) Stopped
b) Warming
c) Running
d) Idle
Answer:
2. True or False? When determining the assay calibration status, you should take note of any
calibration that will expire during assay processing.
Answer:
3. True or False? Calibration is the process used to analyze calibrators of a known concentration, to
record system response values, and to plot measured values against the known concentration.
Answer:
4. True or False? After an assay is installed that requires a calibration, an active calibration must be
generated.
Answer:
5. Select all of the following scenarios whereby Mandatory calibration must be performed:
a) A new reagent number is used.
b) Assay documentation states that a calibration is required when a reagent cartridge is
changed.
c) Certain system maintenance procedures or component replacement procedures are
performed.
d) Documentation that accompanies a new version of an existing assay file states that a
calibration is required.
e) A new assay file that requires a calibration is installed.
f) The calibration has expired.
Answer:
6. True or False? The potentiometric calibration method is used to calculate results for the ICT assays
of sodium (Na+), potassium (K+), and chloride (Cl-).
Answer:
7. Which one of the following is true of active calibration storage?

a) Stored active calibrations are not deleted when the corresponding assay file is deleted.
b) A calibration that is specific to a processing module is stored as the active calibration for the
reagent lot.
c) The system does not use the active calibration as the default calibration for the onboard
reagent lot.
d) A calibration that has a status of Pending QC is not considered to be an active calibration.
Answer:
8. Select all of the scenarios that may occur when you encounter a Failed calibration status:
a) The calibration failed an assay-specific calibration parameter or assay-specific calibration
validity checks.
b) The calibration exceeded the full interval or the adjustment interval.
c) The calibration was not completed successfully because of a hardware error.
d) The operator manually failed the calibration.
Answer:
9. True or False? The photometric calibration methods use measured absorbance values to plot a
calibration curve or to determine a cutoff value.
Answer:
10. Select the three types of calibration used by the i-series.

a) Full calibration.
b) Single reduction calibration.
c) Adjustment calibration.
d) Index calibration.
Answer:
Module 8: Control Orders
Objectives • Understand control sample processing

• Create a control order
• Prepare and load control vials for onboard storage
Module Topics
Quality control needs to be run at least every 24 hours or according to package insert instructions or
to the laboratory quality control rules.
Running all levels of appropriate controls immediately after calibration to verify the newly stored
calibration curve on a specific processing module is required. Testing controls will alert you to any
issue with an assay before you process patient samples.
• Processing Quality control
• Quality control results
• Application Specialist: Reminder: This is a high level overview of QC. Individual QC types are
reviewed in the integration class.
• Application Specialist: If configured, the system software may require QC to be run after
calibration and prior to being able to generate any patient results.
Processing QC
• Requirements for a control sample, bar code labeling, sample volume, specimen handling,
loading and unloading of samples in racks and trays into the RSM are similar to sample
processing that will be reviewed fully in Module 9: Patient Sample Orders.
• Controls can be stored onboard, in vials for immediate use, or run via sample cups in racks
processed through the RSM. Refer to the assay documentation for control requirements.
Onboard vial racks and vial racks are processed as priority racks regardless of the position of the
rack on the loading area of the RSM.
Demonstration: Create a manual control order
• The facilitator will demonstrate how to order a control sample.

• Explain that if bar-coded samples are used or if the control product is
located in the reagent carousel, the rack ID and position number are
not required.
• Explain that controls not loaded in a vial rack and designated as STAT
must be priority loaded to be processed as STAT controls.
• Show how to filter the list of available assays. Tap the option for
c-series, i-series or calculated.
• Inform that:
 For i-series assays, do not order more than 10 tests for each sample
that is loaded in sample cups.
 For c-series ICT assays, do not order more than 15 tests for each
sample that is loaded in sample cups or tubes.
 The total number of tests for each sample includes all assays,
replicates, dilutions, and available reagent lots for the order. Ensure
that the total number of tests for a c-series sample do not exceed
220.
 Review that once you hit add order, it will default to next level for
next order.
Procedure Map Reference: Sample processing > Order tests > Con-
trol orders > Create a control order
Control Sample Processing

• When multiple reagent cartridges for an assay are loaded on the system and before the
sampling process for a control order begins, the system determines which cartridges to use
based on the following configuration parameter and the Reagent Selection options that are
chosen for the order.
• Run Controls for Onboard Reagents by
 Cartridge: The control order runs for each cartridge of the corresponding reagent for each
module.
 Lot: The control order runs only for one cartridge of each reagent lot for each module.

Sample processing > Control sample processing
Demonstration: Prepare and load control vials for onboard storage
• Review how to prepare and load control vials for onboard storage.
• The facilitator will point out to use the onboard vial rack with standoffs.
• The facilitator will demonstrate the placement of the barcode to
make sure it is visible in the rack window.
• Application Specialist: Discuss that when QC is ordered for an
onboard control, the vial rack is removed from the reagent carousel
by the reagent transport and then moved to the appropriate module
sample positioners by the RSM transport. This means that c-series
controls may be stored in the i-series reagent carousel and vice versa.

carousel inventory > Prepare and load vials into vial racks for
onboard storage
In-Use and On-board Stability for control material Onboard

Stability (Hours)
On-Board Stability (Hours)
Displays the maximum time in hours that the control can remain on the reagent carousel. This area is
available only if Yes was selected in the Stored Onboard area.
Note: Onboard stability tracking occurs after the vial is scanned by the RSM bar code reader and is
scheduled to be loaded in the reagent carousel. The onboard stability tracking continues when
the vial is unloaded from the system.
In-Use Stability (Hours)
Displays the maximum time in hours that the control can be used on the processing module without
refrigerated storage. A value of zero indicates that in-use stability is not tracked.
Application Specialist: Discuss that onboard and in-use stability must be provided by the
manufacturer of the control material and can be located in package insert for specific control.
Online Operations Manual (Help):Installation procedures and spe-

cial requirements > system configuration> configure screen, assay
tab> quality control screen > control create/edit screen element
descriptions
Cal/QC Inventory Screen

Access the Cal/QC Inventory screen by tapping the system button. On the Cal/QC Inventory
screen, the operator can view the following information:
 Inventory details for quality control vials that are run on the system
 Inventory details for calibrator vials that are used to calibrate assays
Calibrator and control vials that were previously stored on the system must be loaded into the
same onboard vial rack if the vials are returned to onboard storage.

sumable inventory management > Cal/QC inventory screen
Automated Control Ordering
Controls are recognized by the system in three different ways:
• A manual QC order is generated
• A barcoded QC vial is introduced into the RSM or is present in an onboard vial rack inside the
reagent carousel. The SID for controls in a vial rack or an onboard vial rack is composed of the
control lot number, the control level, and the vial serial number.
• A tube with a QC barcode is put in a sample rack and introduced into the RSM. The SID for
controls in a sample rack is composed of the control lot number and level, and QQQ is added to
the beginning of the SID. QQQ labels cannot be generated directly from the Alinity software but
can be generated from any program that can create labels. Options we will review in this
training program include the Avery template and using the Biorad QCnet website.
Manually create a new quality control lot

• Demonstrate how to manually create a new single-constituent or multi-constituent control lot.
• Inform that the control name can have from 1 through 10 characters and a control lot number
can have from 3 to 9 characters.
• Review the relationship between the Automated selection of Yes or No, and the Time Interval
(Minutes) box.
• Review how to enter QC if you are looking for a result that is less than or greater than.
• Prior to checking calculate mean and SD box, you cannot be in the range low or range high box
or calculate mean/SD will not be an available function.
• For any level beyond level 1, you will need to select which assays are run on the left hand side of
the screen. This is in case a customer does not want to run a certain assay on certain levels
If you forget to select the assays, the file will allow you to save, but when you go to the QC order
screen, levels besides level one will not be available for order.

cial requirements > System configuration > Configure screen,
assay tab> Quality control screen
Automated Control Ordering

Automated control ordering is the process that the system uses to order quality control tests automatically. The
control SID is associated with a predefined test list. Automated control orders are created in the following
ways:
• When a control sample bar code label from an onboard vial rack, a vial rack, or a sample rack is
scanned
• When the system software periodically evaluates the control vials that are stored in onboard vial
racks in the reagent carousel
• When the configured time interval or test interval is exceeded
Evaluation of controls from automated orders

Controls are evaluated for automated orders in three ways
• When they are scanned by the RSM

• Every 15 minutes when they are stored on the system and the instrument status of the PM is
Processing
• Every 15 minutes when they are stored off the system and at least one PM has an instrument
status of Processing
Evaluation by the RSM

When barcoded QC are scanned by the RSM barcode reader, they are evaluated for each PM that has an
instrument status of Processing or Running. If the barcode corresponds to a configured control lot number and
level and an order for the control is present in the system software, that order will be completed. If no control
order is present in the software and the control vial meets the criteria to create an automated order, the
system automatically creates the order and processes the tests for the SID.
Evaluation of controls stored on the system

Control vials that are stored on the system are evaluated for automated control orders every 15 minutes on
each PM that has an instrument status of Processing and when the instrument status transitions from Stopped
or Idle to Running or Processing. On multimodule systems, automated control orders are evaluated on all PMs
on which the analyte can be run.
Evaluation of controls not stored on the system

This evaluation occurs every 15 minutes when at least one PM has an instrument status of Processing and when
the instrument status transitions from Stopped or Idle to Running or Processing. Only the default lot number is
evaluated and only for those controls that have the Automated parameter configured as Yes. A notification
instructs the operator to load the QC vials and orders are created when the vials are loaded.
Notification does not occur:
• When a control order is present for the specified assay and control level
• If the control lot number is expired
• When no reagent cartridge is available for the assay
• If a control is configured with the automated parameter set as No, an automated order will only
be generated if a barcoded QC vial or sample tube with a QQQ barcode is introduced into the
RSM and no order has been created since the configured shift start time.
Changing the Automated QC configuration to yes is beneficial if:

• The Customer is storing QC in an on-board vial rack
• The Customer wants different assays run on a QQQ barcode or barcoded vials at different times
throughout the day
Online Operations Manual (Help):Operating instructions > Speci-

men, calibration and control orders >Automated ordering > auto-
mated control ordering
Activity 1: Create a control order
Purpose: To become proficient at creating a control order.

Actions: Create a control order.
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Procedure Map Reference: Sample processing > Order tests > Con-
trol orders > Create a control order
Activity 2: Prepare and load vials into vial racks for onboard storage
Purpose: To become proficient at preparing and loading vials into vial racks for onboard storage.
Actions: Prepare and load vials into vial racks for onboard storage.
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management > Reagents screen > Prepare and load vials into vial
racks for onboard storage
Activity 3: Load QC samples into sample racks
Purpose: To become proficient at loading QC samples into sample racks.

Actions: Load samples into sample racks. Perform this procedure only if using sample cups.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Load samples into sample racks
Purpose: To become proficient at loading racks on the Reagent and Sample Manager (RSM).
Actions: Load racks on the Reagent and Sample Manager (RSM)
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Activity 5: Initiate or resume sample processing

_______________________________________________________________________
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Activity 6: Unload vials from the Reagent and Sample Manager (RSM)
Purpose: To become proficient at unloading vials from the Reagent and Sample Manager (RSM).
Actions: Unload vials from the Reagent and Sample Manager (RSM).
_______________________________________________________________________
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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Unload vials from the Reagent and Sample Manager (RSM)
Application Specialist Activity: View Cal/QC Inventory screen
Purpose: To become proficient at locating and understanding information provided on Cal/QC

Inventory screen
Actions: Locate and review Cal/QC inventory screen
Discussion: Discuss any questions or issues that may arrive from the activity.
Online Operations Manual (Help): Operating instructions > con-

sumable inventory management > Cal/QC inventory screen
Application Specialist Activity: Automated control orders
Purpose: To become proficient in identifying situations where automated control ordering will
occur.
Actions: Completed written activity Automated control ordering scenarios
Situation Expected Outcome
1.Automated QC parameter is configured to YES and

Technopath QC is stored in an on-board vial rack. QC
was run with Glucose for Level 2 giving a 1-3S. Instrument
has been in running status for >15 minutes since QC out of
range.
2.Automated QC parameter is configured to NO.
Configured QC shift start time is 8am and it is currently
8:15am. Lab technician inserts the sample rack with QQQ
labels onto the RSM
3.Automated QC parameter is configured to YES.
Configured shift start time for Technopath control is set at
3pm and QC is stored in an on-board vial rack. The
instrument has been in idle for the entire day due to a
maintenance issue. At 4pm the Lab Technician changes
the Alinity ci-series status from Idle to Running.
4.Automated QC parameter is configured to YES, controls
are not stored in an on-board vial rack. Troponin control
has a test count interval of 100 and test count has been
exceeded. Lab Technician has NOT introduced QC vials
into RSM.
5.Automated QC parameter is configured to YES, controls
are not store in an on-board vial rack. Controls were run
for all analytes this morning after configured QC shift start
time. The current calibration status for Beta-HCG is
Running. The lab technician introduces Beta-HCG
controls with a QQQ label into the RSM.
Configured QC shift start time is 8am and QC was run this
morning. Calcium control was 1-3SD out for Level 1. Lab
technician inserts rack with QQQ labels.

Configured QC shift start time is 8am, QC was run at
8:30am this morning. Lab technician inserts a sample rack
with QQQ labels.
Resources: Global application trainer Sharepoint.
Knowledge Check: Processing QC

1. True or False? For i-series assays, no more than 10 tests for each sample that is loaded in sample
cups should be ordered.
Answer:
2. True or False? For c-series ICT assays, no more than 15 tests for each sample that is loaded in
sample cups should be ordered.
Answer:
3. True or False? The yellow onboard vial rack with standoffs should be used to load vials for
onboard storage.
Answer:
QC Results
This lesson explains how to review QC results. Once QC sample processing completes, you can
review results and flags to determine whether to release results or rerun the test.
This lesson will provide you with basic knowledge about QC results.
 Describe the quality control result flags
 Understand quality control analysis
 Understand Westgard rule application
 Understand Westgard rule descriptions
 Levey-Jennings (Graph) screen.
 Display the value for a Levey-Jennings point.
 Exclude or include a Levey-Jennings point.
 View the details for a Levey-Jennings point.
 Add a comment to a Levey-Jennings point.
 Quality Control Summary screen.
 Create a Levey-Jennings graph.
 Clear a control failure.
 View the quality control (QC) summary data.
Descriptions of the quality control results flags

• The following are the quality control result flags:
 CNTL
 Westgard rule
 EXP*
 EXPC*
 A#1* (c-series)
 A#2* (c-series)
 < or >
 FLEX* (c-series)
 PSHH* (c-series ICT assays)
 *These flags are carried over from a constituent assay result to a calculated assay result
 CORR*
Online Operations Manual (Help): Operating instructions > Results

screen > Descriptions of quality control result flags
Demonstration: Quality control analysis
• The three items that help make sure quality results and optimal system
performance are achieved are:
 Carefully follow all directions in the Operations Manual (Help) and
the reagent manufacturer's assay documentation.
 Never use expired or contaminated consumables.
 Perform maintenance procedures and calibration procedures as
recommended.
• Identify quality control issues that must be evaluated and resolved
before testing specimens.
• A system configuration parameter determines whether controls are
run for an assay per reagent lot or per reagent cartridge. There is an
additional configuration setting that will allow the user to patient
disable a reagent upon control failure. If a control failure occurs on
one or more reagent cartridges, the failure prevents the use of the
cartridge. If QC is run per reagent cartridge and any control level fails,
the individual reagent cartridge is patient disabled. If QC is run per
reagent lot and a tested control level fails, all reagent cartridges for
that lot are patient disabled, including any that are subsequently
loaded on the system. The system enables the reagent cartridge or
reagent lot once the failed quality control result is rerun and the result
is within acceptable limits.
• Point out that when a control fails, a CNTL flag will be assigned to all
results. The CNTL flag indicates the result was ‘calculated after the
quality control failed. The flag is displayed on subsequent results until
the failed quality control (QC) is rerun and the results are in range or
until the control failure is cleared. Clearing a control failure should only
be used when it is not possible to rerun the control materials. When
out-of-range QC results are deleted, the CNTL flag is not removed from
specimen results.
• Application Specialist: Review that there is a procedure for clearing a
control failure that will be reviewed later in this section. A system
administrator can clear a control failure and a comment must be
entered.
Online Operations Manual (Help): Operating instructions > Quality

control analysis
Westgard Rule Descriptions

• Review that Westgard rules are configured.
• The Alinity ci-series compares a control result, upon completion, against the expected mean and
standard deviation for the control level. Previous results, released and unreleased, for the same
assay and module are considered in the analysis.
• Control results marked as excluded are not considered.
• Review the Westgard rule descriptions.

 The default settings are:
 1-2s is a warning
 1-3s is a failure
• Only Westgard rules that are configured as a failure produce a CNTL flag for a specimen result.
• The following are the Westgard rules used by the Alinity ci-series:
 1-2s
 1-3s
 2-2s 1R 1M
 2-2s 1R xM
 2-2s xR 1M
 R-4s
 4-1s 1M
 4-1s xM
 10-x 1M
 10-x xM

control analysis > Westgard rule application > Westgard rule
descriptions
Quality Control Summary screen

• Review the Quality Control Summary screen.
The following are the functions the operator can perform on the Quality Control Summary
screen:
 Find information about a specific control based on specified search criteria.
 Access quality control information.
 Create a Levey-Jennings graph for a selected assay control level.
 Print the QC Analysis Report and the QC Summary Report.

control analysis > Quality Control Summary screen
Levey-Jennings (Graph) screen
The following are the functions the operator can perform on the Levey-Jennings (Graph) screen:
 View a maximum of six Levey-Jennings graphs and the statistical data for the same control
name and lot number for a specific processing module.
 View the Levey-Jennings graphs for the same assay, control name, and lot number for a
maximum of four processing modules of the same type in a multimodule system.
 Change the criteria for a Levey-Jennings graph and its data.
 Include or exclude points from a Levey-Jennings graph.
 Print a Levey-Jennings report.
 Recalculate the Westgard analysis for a Levey-Jennings point.
 View the details of a selected Levey-Jennings point.
 Add a comment to a Levey-Jennings point.
 Display the value for a Levey-Jennings point

control analysis > Levey-Jennings (Graph) screen
Create a Levey-Jennings graph

Review Create a Levey-Jennings graph.
• Inform to tap module 6 to display the QC summary data for calculated assays.
• Inform that the default date range is composed of the last 31 days, including the current date.
• Inform to filter the list of QC summary data, tap Search
• Inform that the Graph button is unavailable if more than one assay or lot number is selected on
the Quality Control Summary screen.
• Review the Comparison Type choices.
• The previous selections for module, assay, control name, lot number, control level, and date
range are displayed on the Quality Control Summary screen.
Online Operations Manual (Help): Quality control > Quality control

analysis > Create a Levey-Jennings graph
Display the value for a Levey-Jennings point
Review how to display the value for a Levey-Jennings point.
Procedure Map Reference: Quality control > Quality control analy-

sis > Display the value for a Levey-Jennings point
Exclude or include a Levey-Jennings point

• Review exclude or include a Levey-Jennings point
.

sis > Exclude or include a Levey-Jennings point
View the details for a Levey-Jennings point
Review view the details for a Levey-Jennings point.

sis > View the details for a Levey-Jennings point
Add a comment to a Levey-Jennings point
Review how to add a comment to a Levey-Jennings point.

sis > Add a comment to a Levey-Jennings point
View the quality control (QC) summary data

• Review View the quality control (QC) summary data.
• Inform that the QC summary data is not displayed if the values for expected mean and
expected standard deviation (1 SD) are not defined for the control.
• Inform that the control results that were run between and on the entered dates are included in
the QC summary data.

sis > View the quality control (QC) summary data
Clear a control failure

• Review Clear a control failure.
• An assay control level that has a control failure is displayed in red text on the Quality Control
Summary screen
• After the control failure is cleared, Message code 1171 is logged with the comment and the text
of the assay control level is displayed in black..

sis > Clear a control failure
View the control summary details

• Review view the control summary details.
• The quality control (QC) summary data is not displayed if the values for expected mean and
expected standard deviation (1 SD) are not defined for the control.
• The Control results that were run between and on the entered dates are included in the QC
summary data.

sis > View the control summary details
System Capacities
Release control results 20,000 results per processing

module
Released specimen results* 200,000 results
Unreleased results:* 20,000 results
• Specimens
• Controls
• Calibrations
Unreleased results include test orders,
tests in process, and exceptions.
* Results include system-ordered constituents for calculated assays. The constituent results
cannot be displayed on the Results screen.
Archiving QC
 To Archive QC, follow the same procedure as archiving patient results but go to the QC tab.
Archiving patient results will be covered in Section 9: Patient Sample Ordering.
Demonstration: Archive QC results
• The facilitator will demonstrate how to archive the results using system
software.
• Show the difference between All, Incremental and Selected when
archiving.
 All items: This option archives all results within a defined date range.
 Incremental: This option archives all results that do not have a
status of Archived within a defined date range.
 Selected items: This option is available only if results were selected.
Activity 1: View QC results in the Results screen
Purpose: To become proficient at viewing the QC results previously generated in the Results
screen.
Actions: View the QC results previously generated in the Results screen.
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screen
Activity 2: Description of the QC Result Flags
Purpose: To become proficient at describing the QC Result Flags.

Actions: Describe the QC result flags produced. If no flags were produced, review the
Operations Manual (Help) and list the control flags.
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screen > Descriptions of quality control result flags
Activity 3: View QC results in the Sample Status screen
Purpose: To become proficient at viewing the QC results previously generated in the Sample
Status screen.
Actions: View the QC results previously generated in the Sample Status screen.
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_______________________________________________________________________
Online Operations Manual (Help): Operating instructions > Speci-

men, calibration, and control orders > Sample Status screen
Activity 4: Delete a QC result or an exception
Purpose: To become proficient at archiving and deleting a QC result or deleting an exception

previously generated in the Sample Status screen.
Actions: Archive and delete a QC result or exception previously generated in the Sample Status
screen.
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Procedure Map Reference: Sample processing > Result manage-

ment > Delete a sample result or an exception
Activity 5: Rerun a test or an exception for a specimen or control
Purpose: To become proficient at rerunning a test or exception for a specimen or control.

Actions: If an exception was generated, find the exception and rerun. If an exception was not
generated, rerun any QC as an automated dilution.
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ment > Rerun a test or an exception for a specimen or control
Activity 6: Add a comment to a QC result or exception from the Results

screen or the Sample Status screen
Purpose: To become proficient at adding a comment to a QC result or exception.

Actions: From the Results screen or the Sample Status screen, add a comment to a QC result or
exception.
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ment > Add a comment to a result or an exception
Activity 7: Release a QC result from the Results screen or the Sample Status
screen
Purpose: To become proficient at releasing a QC result from the Results screen or the Sample
Status screen.
Actions: From the Results screen or the Sample Status screen, release all QC specimen results.
_______________________________________________________________________
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ment > Release a specimen result or a control result
Activity 8: Archive QC results
Purpose: To become proficient at archiving QC results.

Actions: Archive all QC results generated during the previous activity.
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Procedure Map Reference: Sample processing > Archive > Archive

the results
Activity 9: Display the value for a Levey-Jennings point
Purpose: To gain an understanding of Levey-Jennings values.

Actions: Display the value for a Levey-Jennings point.
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sis > Display the value for a Levey-Jennings point
Activity 10: View the details for a Levey-Jennings point
Purpose: To gain an understanding of Levey-Jennings details.

Actions: Record the date and time the control point was run.
_______________________________________________________________________
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sis > View the details for a Levey-Jennings point
Activity 11: Add a comment to a Levey-Jennings point
Purpose: To become proficient at add a comment to a levey-Jennings point.

Actions: Using the selected control point, add a comment. Record the comment and verify that
the comment appears with the point.
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sis > Add a comment to a Levey-Jennings point
Activity 12: Disabled reagent after QC failure
Purpose: To become familiar with what happens when a reagent kit is disabled after QC failure.
Actions:
Participants will run QC so that one level is out of range and note what happens to reagent kit.
Participant will repeat that level of QC so that value is in range and note what happens to
reagent kit.
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Activity: Clearing a Control Failure (Application Specialist)
Purpose: To become familiar with how to clear a control failure.

Actions:
Participants will run QC so that the last level is out of range and then run a patient sample for that
assay. Note CNTL flag on patient results. Participant will clear control failure and run patient
sample for that assay. Note if CNTL is on this specimen.
Review
1. Select all of the following guidelines to help ensure quality results and maintain optimal system
performance:
a) Carefully follow all directions in the operations manual and the reagent manufacturer's assay
documentation.
b) Do not use expired or contaminated consumables.
c) QC issues do not have to be evaluated and resolved before specimens are tested.
d) Perform maintenance procedures and calibration procedures as recommended.
Answer:
2. True or False? QC data includes both unreleased and released control results.
Answer:
3. True or False? When Westgard rules are configured, upon completion of the control, the system
compares a control result against the expected mean and standard deviation for the control
level.
Answer:
4. Which one of the following procedures do you perform to create a control order?
a) For bar-coded samples, write down the rack ID and the position number.
b) On the menu bar, tap Orders.
c) Load controls that are designated as STAT to be processed as STAT controls at a later time.
d) Tap the correct number of replicates for each dilution if the default number of replicates for
one or more dilutions is correct.
Answer:
5. Select all of the following requirements for handling QC specimens:

a) Verify that calibrators or controls are within the expiration date on the bottle.
b) Use the sample gauge to verify aliquot tube volumes for c-series whole blood applications.
c) Refer to the assay documentation to determine the minimum sample volume that is required
in the sample cup or tube for the tests to be processed.
d) Verify that the amount of sample in the aliquot tube exceeds the 8mm sample gauge line.
Answer:
6. True or False? A USB flash drive is necessary in order to archive results.

Answer:
7. Which one of the following is a prerequisite to unloading samples from the Reagent and Sample
Manager (RSM)?
a) The blinking green status indicator is illuminated on the Reagent and Sample Manager (RSM).
b) The steady green status indicator is illuminated on the Reagent and Sample Manager (RSM).
c) Alternating green and amber status indicators are illuminated on the Reagent and Sample
Manager (RSM).
d) All of the above.
Answer:
8. Select all of the following screens where you would add a comment to a result or an exception:
a) Results screen
b) Result Details screen
c) Release a Specimen Result or a Control Result screen
d) Sample Status screen
Answer:
9. Select all of the following system states in which you can load and process racks onto the
Reagent and Sample Manager (RSM):
a) Idle
b) Running
c) Stopped
d) Processing
Answer:
10. How long are the controls stable for when loaded onboard?
Answer:
11. What are the steps to delete the QC results?

Answer:
12. True or False. Control results for an assay are evaluated at completion against all Westgard rules
that are enabled for the assay.
Answer:
13. Select all of the following functions the operator can perform on the Levey-Jennings graph
screen:
a) View the Levey-Jennings graphs for the same assay, control name, and lot number for a
maximum of four processing modules of the same type in a multi-module system
b) Include or exclude points from a Levey-Jennings graph
c) Add a comment to a Levey-Jennings point
d) View a maximum of six Level-Jennings graphs and the statistical data for the same control
name and lot number for a specific processing module
Answer:
Module 9: Patient Sample Orders
Objectives: • Preparing for operation

• How to order specimen tests
• Sample management
• Results management
Module Topics
Sample processing includes procedures used to prepare samples, initiate processing, unload
samples, and manage results. In this module, we will discuss sample processing steps.
• Preparing for operation
• Order specimen tests
• Sample management
• Results management
Preparing for Operation
Prior to ordering and running patient samples you should confirm:

• Supply and waste inventory is adequate
• Reagent carousel inventory is adequate
• Maintenance has been performed, as required
• Calibrations have been performed
• QC has been run and validated to be in range
Activity 1: Verify the supply and waste inventory
Purpose: To become proficient at verifying the supply and waste inventory.

Actions: Verify the supply and waste inventory.
Procedure Map Reference: Check the inventory > Verify the supply
and waste inventory
Activity 2: Verify the reagent carousel inventory
Purpose: To become proficient at verifying the reagent carousel inventory

Actions: Verify the reagent carousel inventory.

ation > Check the inventory > Verify the reagent carousel

ation > Perform daily maintenance > Perform a maintenance pro-
cedure or a diagnostic procedure
Knowledge Check: Prepare for Operations

1. Select all of the following tasks you should perform when preparing for operation:
a) Check the inventory.
b) Replenish the inventory and empty the waste.
c) Load samples into sample racks.
d) Perform daily maintenance.
Answer:
2. True or False? View the assay calibration status before sample processing is initiated or when a
status indicator is displayed.
Answer:
3. Order the following steps in the correct sequence to load racks and cartridges into trays.
a) Slide the rack or cartridge into the tray until the rack or cartridge stops
b) Position the rack or cartridge so that the rack handle or cartridge handle is located at the
front of the tray, which is indicated by an arrow.
c) Confirm that the rack or cartridge is flush against the back of the tray
Answer:
Order Specimen Tests

Orders can be created from a laboratory information system (LIS), middle ware system, or created
manually. The orders can include demographic information and test selection. Orders provide
specimen processing instructions to the Alinity ci-series. Prior to generating patient results, it is critical
to calibrate needed assays and run Quality Controls. Ordering calibration and controls and review
of results will be covered in sections 5 and 7 of this guide.
After this section, you will be able to review orders and specimen tests, including:
 Create a single specimen order.
 Create a bar-coded batch specimen order.
 Add a test to a specimen order.
 Delete a test from a specimen order.
 Add a comment to an order.
 Print the list of orders.
 Description of the Orders screen.
 Description of the Order Details screen.
 Description of the test statuses.
 Description of the processing codes.
Demonstration: Create a single specimen order
• The facilitator will demonstrate how to create a specimen order using

the system software.
• Application Specialist: Point out that most orders are through LIS
and/or middleware not manual. Manual orders are performed when
the system is not connected to a host computer, the host computer is
not functioning, or an additional test is needed.
• Explain that the Create Order icon on the menu bar is a configurable
icon and is an alternate way to go to the Create Order screen.
Procedure Map Reference: Sample processing > Order tests >

Specimen orders > Create a single specimen order
Demonstration: Create a bar-coded batch specimen order
• Demonstrate how to create a bar-coded batch specimen order using

• Explain that the Create Order icon on the menu bar is a configurable
icon and is an alternate way to navigate to the Create Order screen.
• Explain when loading specimens for batch processing, do not load
calibrators or leave empty spaces between samples. Empty spaces
are identified as invalid samples and generate a message code. The
functionality for host query and laboratory automation system is
unavailable when a batch order is being processed.
• Samples with explicit orders and controls can be processed within a
batch order. They system runs only the explicit orders associated with a
sample and does not create batch orders for the sample.
• Explain do not add a test to an order within a batch. If a test is added
to an order that is part of a batch order, the additional test is
processed instead of the batch tests. Separately order the additional
test and load the sample after batch processing is completed.
• Batch processing begins on the sample labeled with the starting SID
and continues until the sample labeled with the ending SID is
processed. All samples between the starting SID and ending SID are
included in the batch process.

Specimen orders > Create a bar-coded batch specimen order
Demonstration: Add a test to a specimen order
• Explain that adding a test to the order is the same as creating a new
order using the same SID.
• Demonstrate the Search feature to find a specimen order.
• Demonstrate how to Add a test to a specimen order.
• Review that if a test is added to an order that is part of a batch order,
the additional test is processed instead of the batch tests. Separately
order the additional test and load the sample after batch processing is
completed.

Specimen orders > Add a test to a specimen order
Demonstration: Delete a test from a specimen order
• The facilitator will demonstrate how to delete a test from a specimen

order using the system software.
• Application Specialist: Point out that test status must be pending or in
process.

Specimen orders > Delete a test from a sample order
Demonstration: Add a comment to an order
• The facilitator will demonstrate how to add a comment to an order

using the system software.

Specimen orders > Add a comment to an order
Demonstration: Print the Order List Report
• The facilitator will demonstrate how to print the Order List Report using
• Application Specialists: A print preview can be generated and
reviewed if a hard copy of the printout is not needed. Volumes
needed are on the order list report.
Description of the Orders screen

 Identify what can be viewed from the Orders screen.
 Explain that you can access the Orders screen by tapping the Orders icon on the menu bar
or tapping the Tests In Process button on the processing module illustration.
 Identify the functions that can be performed from the Orders screen.Review how to use Find
function and how to reorganize the results by pressing the header at the top of the columns

men, calibration, and control orders > Orders screen
Description of the Order Details screen

 Describe the Order Details screen.

men, calibration, and control orders > Orders screen >Order
Details screen
Descriptions of test statuses

The following are a list of tests statuses:
 Pending
 Scheduled
 Running
 In Process
 Exception
 Complete

men, calibration, and control orders > Orders screen > Descriptions
of test statuses
Descriptions of Processing Codes

The following are a list of processing codes:
 S (STAT). This only designates the sample as Stat, samples must be priority loaded to process
the samples as Stat.
 D (Automated dilution)
 M (Manual dilution). Not all assays support manual dilutions. Assays that do not support
manual dilution are displayed as unavailable when a manual dilution is selected.
 R (Rerun)
 * (Original result)
 B (batch)
 C (comment)
Online Operations Manual (Help): Operating Instructions >

Specimen, calibration, and control orders > Orders screen >
Descriptions of processing codes
Activity 1: Identify the functions that can be performed on the Orders

screen
Purpose: To become proficient at identifying the Orders screen functions.

Actions: List the functions that can be performed on the Orders screen.
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men, calibration, and control orders > Orders screen
Activity 2: Identify the Different Test Statuses
Purpose: To become proficient at identifying the various test statuses.

Actions: Match the test statuses with the description.
Test Status Description

___ A - Pending 1. The test is ordered, but the RSM bar code
reader has not scanned the
corresponding sample.
___ B - Scheduled 2. The test is ordered, the sample scanned,

and the instrument is processing the
sample.
___ C - Running 3. The test has been ordered and the

sample has been scanned RSM bar code
reader, but instrument has not aspirated
the sample.
___ D - In Process 4. The tests that are necessary to calculate

(calculated assay) the test result are in process
___ E - Exception 5. The test order failed to complete or

generate a result.
___ F - Complete 6. The test is complete.

of test statuses
Activity 3: Identify the Different Processing Codes
Purpose: To become proficient at identifying the various processing codes.

Actions: Match the processing code with the status description.
Processing code Description

___ - S 1. The sample is ordered as a STAT sample.
___ - D 2. The sample is diluted manually.
___ - M 3. The test is an automated dilution with a

dilution factor that is greater than 1, or the
test is an automated dilution that is not
the first configured dilution.
___ - R 4. The test is a rerun.
___ - * 5. The test is an original result for a rerun.
___ - C 6. The test has a comment.
___ - B 7. The test is part of a batch order.

of processing codes
Activity 4: Create a Specimen Order
Purpose: To become proficient at creating specimen order.

Actions: Create three to five non-bar coded specimen orders. In the three to five orders, include
one with patient details defined, one with replicates defined, and one with dilutions defined.
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Specimen orders > Create a specimen order
Activity 5: Add a test to a specimen order
Purpose: To become proficient at adding a test to a specimen order.

Actions: Add a test to one of the specimen orders created in Activity 4.
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Specimen orders > Add a test to a specimen order
Activity 6: Delete a test from a specimen order
Purpose: To become proficient at adding a test to a specimen order.

Actions: Delete a test from one of the specimen orders created in Activity 4.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Specimen orders > Delete a test from a sample order
Activity 7: Add a comment to an order
Purpose: To become proficient at adding a comment to a specimen order.

Actions: Add a comment to one of the specimen orders created in
Activity 4.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Specimen orders > Add a comment to an order
Activity 8: Print the list of orders
Purpose: To become proficient at printing the list of orders.

Actions: Print an Order List Report.
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
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Procedure Map Reference: Sample processing > Print > Print a

report
Knowledge Check: Order Specimen Tests

1. True or False? Before you enter the SID, you should confirm that the SID is not reused before
previously pending orders are completed or are deleted.
Answer:
2. Select all of the following items that represent a test status.

a) Running
b) Testing
c) Exception
d) Scheduled
Answer:
3. True or False? When running a bar-coded batch you can place a calibration in the middle of the
batch order.
Answer:
Sample Management
The Alinity ci-series offers highly automated sample management.
The progression of samples through the Alinity ci-series differs based on the system configuration
and the available reagent inventory.
Various hardware components are used to process assays; however, not all assay types use
every component on the system. The system continues to process assays when the appropriate
hardware component is available.
This lesson will provide you with basic knowledge about specimen processing.
 Identify the sample bar code requirements.

 Identify the sample specifications and requirements.
 Identify the requirements for handling specimens.
 Load samples into sample racks.
 Load racks into trays.
 Load trays on the Reagent and Sample Manager (RSM).
 Load racks on the Reagent and Sample Manager (RSM).
 Initiate or resume sample processing.
 Unload samples from the Reagent and Sample Manager (RSM).
Sample bar code label requirements
• Identify the different components of the bar code label guidelines.
• The facilitator will point out the factors that affect the number of characters that can fit on a
sample bar code label.
• Identify the correct and incorrect placement of the bar code label.
• Application Specialist: Review that Alinity is not capable of printing a series of numeric barcodes
like the ARCHITECT was able to.

and specifications > Specifications and requirements > Bar code
label requirements > Sample bar code label requirements > Sam-
ple bar code label guidelines
Sample Specifications
• Review the sample cup and tube specification and requirements.
• Application Specialist: Per Operations Manual, specifications sample racks that start with the
letters A through C cannot hold tubes with an outside diameter of greater than 13.2 mm. Using
16mm tubes in these racks could damage them, there is a customer letter available if these
racks are present in the customer inventory.
• Review the minimum sample volume requirements for sample cups, aliquot tubes, and primary
tubes. There is an 8 mm sample gauge located on the sample racks. Review this sample gauge
should not be used to verify aliquot tube volumes for c-series whole blood applications. The
sample volume above the separation point (clot, gel separator, plasma, red cells) in a primary
tube is a minimum of 8 mm.
• Explain onboard storage and the effects of evaporation.

and specifications > Specifications and requirements > Sample
specifications and requirements
Requirements for handling specimens

• Review the requirements for collection and for preparation and storage.
• Review the requirements for handling specimens.
Online Operations Manual (Help): Operational precautions and

limitations > Requirements for handling the specimens
Demonstration: Load samples into racks
• Use the graphics in the Operations manual (Help) to review this lesson.
• Identify the sample rack.
• Demonstrate proper loading of a sample rack.
• Review the use of the sample gauge to verify aliquot tube volumes.
• Remind that the operator has the responsibility to load the correct
sample in the correct rack and position.
• Remind that when loading sample cups or tubes, the sample cups or
tubes must be pushed down completely in the sample rack and not
tilted.
• Remind users to use caution to avoid splashing the sample.
• Application Specialist: Point out that sample positions are the opposite
of the ARCHITECT sample racks. Position 1 is the closest to the operator
when holding the rack as though they are going to insert it on the
instrument. If you are looking at a rack from the side, positions 1-6 go
from left to right.
• Application Specialist: Per Operations manual sample tube
requirements, sample racks starting with the letter A-C hold tubes sized
10mm to13mm. Sample racks with the letters E-T can hold tubes sized
10mm to 16mm.

Demonstration: Load racks into trays
• The facilitator will demonstrate loading racks into trays either using the
Operations Manual (Help) and animations, or in front of the instrument
if the number of participants is small.

Load racks and cartridges into trays
Demonstration: Load trays on the Reagent and Sample Manager (RSM)
• The facilitator will demonstrate loading trays on the Reagent and

Sample Manager (RSM) using either the Operations Manual (Help)
procedure and animations, or in front of the instrument if the number
of participants is small.
• Avoid splashing the sample outside the sample cups and tubes when
transporting or loading racks. On a multimodule system, samples are
routed to the first available processing module. If multiple processing
modules are available, the system first routes the samples to the
numbered module that has the lowest number.

Demonstration: Load racks on the Reagent and Sample Manager (RSM)
• The facilitator will demonstrate loading racks on the RSM using the
Operations Manual (Help) and animations, or in front of the instrument
if the number of participants are small.
transporting or loading racks.

Load racks
Demonstration: Initiate or resume sample processing
• Identify the required instrument status for this procedure.

• When multiple reagent cartridges with active calibrations are loaded
on the Alinity ci-series, the following criteria are evaluated in this order
to determine which one to process a test:
1. The reagent cartridge nearest to its open stability expiration date
2. The reagent cartridge nearest to its reagent lot expiration date
3. The reagent cartridge with the fewest remaining tests

Demonstration: Unload samples from the Reagent and Sample Manager

(RSM)
• The facilitator will demonstrate Unload samples from the Reagent and
Sample Manager (RSM).
• Confirm that the status indicators is illuminated and blinking green, a
steady green, or alternating green and amber on the Reagent and
transporting or loading racks.
• Application Specialists: Review the RSM statuses

Unload samples from the Reagent and Sample Manager (RSM)
Activity 1: Sample bar code label guidelines
Purpose: To demonstrate a knowledge of the sample bar code label components.

Actions: List the sample bar code label components used on an Alinity ci-series.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

and specifications > Specifications and requirements > Bar code
label requirements > Sample bar code label requirements > Sam-
ple bar code label guidelines
Activity 2: Minimum sample volume requirements
Purpose: To demonstrate a knowledge of the minimum sample volume requirements.

Actions: List the minimum sample volume requirements for the three sample vessel types used on
the Alinity ci-series.
_______________________________________________________________________
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

and specifications > Specifications and requirements > Sample
specifications and requirements > Sample volume requirements
Activity 3: Requirements for handling specimens
Purpose: To demonstrate a knowledge of the requirements for handling specimens.

Actions: Review and list two requirements that must be followed when preparing and storing
specimens.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Online Operations Manual (Help): Operational precautions and

limitations > Requirements for handling the specimens
Activity 4: Load samples into sample racks
Purpose: To become proficient at loading samples into sample racks.

Actions: Prepare and load the previously ordered samples into two sample racks.
Note: Samples will be provided by the instructor.
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Activity 5: Load racks into trays
Purpose: To become proficient at loading samples into sample racks.

Actions: Load a rack into the tray.
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Load racks and cartridges into trays
Activity 6: Load trays on the Reagent and Sample Manager (RSM)
Actions: Load the tray on the Reagent and Sample Manager (RSM).
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_______________________________________________________________________

Purpose: To become proficient at loading racks on the Reagent and Sample Manager (RSM).
Actions: Load the other rack on the Reagent and Sample Manager (RSM).
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_______________________________________________________________________
_______________________________________________________________________

Activity 8: Initiate sample processing
Purpose: To become proficient at initiating sample processing.

Actions: Initiate sample processing.
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_______________________________________________________________________
_______________________________________________________________________

Activity 9: Unload samples from the Reagent and Sample Manager (RSM)
Purpose: To become proficient at unloading samples from the Reagent and Sample Manager
(RSM).
Actions: When the samples have completed processing, unload samples from the Reagent and
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Unload samples from the Reagent and Sample Manager (RSM)
Knowledge Check: Sample Management

1. Select all of the following tasks you must perform when preparing for operation.
a) check the inventory
b) Replenish the inventory and empty the waste
c) Print a report
d) Perform daily maintenance
Answer:
2. True or False? The progression of samples through the Alinity ci-series differs based on the system
configuration and the available reagent inventory.
Answer:
3. Which one of the following symbologies can be used on the Alinity ci-series?
a) Code 39
b) Codabar
c) Interleaved 2 of 5
d) Code 128 (Subsets A, B, and C)
Answer:
Result Management
This lesson explains how to review patient results. Once patient sample processing completes,
you can review results and flags to determine whether to release results or rerun the test.
This lesson will provide you with basic knowledge about patient results. After completing this
lesson, you should be able to:
 Describe the Results screen.
 Describe the Result Details screen.
 Describe the Sample Status screen.
 Describe the specimen result flags.
 Describe the transmission statuses.
 Rerun a test.
 Add a comment to an unreleased result or exception.
 Release a specimen result.
 Delete a sample result or an exception.
 Transmit a result to the host.
 Archive results.
 Describe system capacities for results.
Demonstration: Description of the Results screen
• The facilitator will demonstrate how to access the Results screen using
• There are four tabs when you go into the results screen. Unreleased,
Specimen, Control, and Exception. The Unreleased tab is not displayed
if patient and control release modes are set to automatic or
automatic with exceptions.
• Review that the following information can be reviewed from the results
screen:
 Module ID
 R/P
 SID
 Name
 Assay
 Result
 Interpretation
 Flag
 Code
 S The sample is ordered as a STAT sample.
 D The test is an automated dilution with a dilution factor that is
greater than 1, or the test is an automated dilution that is not
the first configured dilution.
 M The sample is diluted manually.
 R The test is a rerun.
 * The test is an original result for a rerun.
 C The test has a comment.
 Time
• Identify the functions that can be performed from the Results screen.
Demonstration: Description of the Results screen (continued)
 Function buttons:
 Select all
 Search
 Print
 Details
 Rerun.
 Release Moves the selected test results to the specimen tab or
the control tab
 Delete This will ask you to confirm if you want result to be
deleted.
 Text Size

screen
Demonstration: Description of the Results Detail Screen
• The facilitator will demonstrate how to access the Result Details screen
using the system software.
• Point out that the Result Details screen provides details for specimen
results, controls results, and exceptions by selecting the chart view
function button. If there are reruns, there will also be a rerun tab.
• Explain reaction graphs for the Alinity c-series tests are viewable from
this screen.
• Application Specialist: Point out that photometric read points are
different from ARCHITECT. (33 vs 38)

screen > Result Details screen
Demonstration: Description of the Sample Status screen
• The facilitator will demonstrate how to access the Sample Status

screen by tapping the Sample Status menu icon, or on the Home
screen, tapping the Sample Status button next to Total samples.
• Additional information is indicated by the following colors:
 Black: The test has a status of Scheduled, Pending, Running, or In
Process.
 Green: The test has completed but is not released.
 Blue: The test has completed and has been released.
 Red: The test is an exception or has a flag.
Application Specialist: Discuss the suspend function. When a rack is suspended,
the processing module completes sample aspiration of the current sample. After
sample aspiration is completed, the rack is returned to its original position on the
RSM and any scheduled tests become exceptions and are not processed. Sus-
pend can be used if there is an aspiration error while running a calibration and
you do not wish for the sampling of the rest of the replicates to be completed.

Demonstration: Description of the specimen result flags
• Review the specimen result flags.

• The following are the specimen result flags:
 EXP*
 EXPC*
 A#1* (Alinity c-series)
 A#2* (Alinity c-series)
 CNTL*
 < or >
 FLEX* (Alinity c-series)
 LL or HH
 PSHH* (Alinity c-series ICT assays)
 LOW or HIGH
 CORR*

screen > Descriptions of specimen result flags
Demonstration: Descriptions of transmission statuses
 These are located on the sample details screen and the Result
Details flyout and are not present for calibrators.
• The following are the transmission statuses:
 Transmitted.
 Pending transmission.
 Pending collation.

screen > Descriptions of transmission statuses
Demonstration: Delete a sample result or an exception
• The facilitator will demonstrate how to delete a sample or an

exception using the system software.

ment > Delete a sample result or an exception
Demonstration: Rerun a test or exception for a specimen
• Explain that the rerun request can be made from either the Sample
Status screen or the Results screen. Prior to rerunning the sample, the
user should confirm the volume is adequate and the sample integrity is
acceptable.
• The facilitator will demonstrate how to rerun a specimen test using the
system software.

Demonstration: Add a comment to a result or an exception
• The facilitator will demonstrate how to add a comment to a result or

exception using the system software.
• Explain that results can be found from the Sample Status screen or the
Results screen.
• Point out that comments are displayed and printed with the result or
exception. In addition, comments for samples and tests are displayed
if comments were entered.

ment > Add a comment to a result or exception
Demonstration: Release a specimen result
• Explain that automatic host transmission can be configured and will be

discussed in another module. If the configuration is turned on, results
are automatically released to the host when they are completed and
there is no unreleased tab in the Results screen.
• The facilitator will demonstrate how to release a specimen result using

Demonstration: Transmit a result to the host
The facilitator will demonstrate how to manually transmit a result to the

host.
Note: If instruments are not configured to a host, this procedure

cannot be demonstrated.

ment > Transmit a result or an exception to the host
Demonstration: Archive the patient results
• The facilitator will demonstrate how to archive the results using system
software.
• Show the difference between All, Incremental and Selected when
archiving.
 All items: This option archives all results within a defined date range.
 Incremental: This option archives all results that do not have a
status of Archived within a defined date range.
 Selected items: This option is available only if results were selected.

the results
Description of System Capacities for results

• Released specimen results can include 200,000 results.
 Unreleased results have a capacity of 20,000 results
• Unreleased results can include specimens, controls, calibrations, test orders, tests in process, and
exceptions.

and specifications > specifications and requirements > system
capacities > software data storage capacities
Activity 1: View specimen results in the Results screen
Purpose: To become proficient at viewing specimen results in the Results screen.

Actions: View the previously generated results in the Results screen.
Application Specialist: View a c-series results graph.
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_______________________________________________________________________

screen
Activity 2: Description of the specimen result flags
Purpose: To become knowledgeable about the specimen result flags.

Actions: List the specimen result flags generated by the system.
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_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

screen > Descriptions of specimen result flags
Activity 3: View specimen results in the Sample Status screen
Purpose: To become viewing the specimen results in the Sample Status screen.
Actions: View the results previously generated in the Sample Status screen.
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_______________________________________________________________________
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_______________________________________________________________________

Activity 4: Delete a specimen result or an exception
Purpose: To become proficient at deleting a specimen results or an exception.

Actions: Find a result in the Sample Status screen and delete the result.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Online Operations Manual (Help): Sample processing > Result

management > Delete a sample result or an exception
Activity 5: Rerun a specimen test
Purpose: To become proficient at rerunning a specimen test.

Actions: If an exception was generated, find the exception and rerun the exception. If an
exception was not generated, rerun any specimen as an automated dilution.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 6: Add a comment to a result or exception from the Results screen
Purpose: To become proficient at adding a comment to a result or exception from the Results
screen.
Actions: From the Results screen, add a comment to a result or exception.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 7: Release a specimen result from the Results screen
Purpose: To become proficient at releasing a specimen result from the Results screen.
Actions: From the Results screen, release a specimen result.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 8: Add a comment to a result or an exception from the Sample

Status screen
Purpose: To become proficient adding a comment to a result or an exception from the Sample
Status screen.
Actions: From the Sample Status screen, add a comment to a result or an exception.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 9: Release a specimen result from the Sample Status screen
Purpose: To become proficient at releasing a specimen result from the Sample Status screen.
Actions: From the Sample Status screen, release a specimen result.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

Activity 10: Archive Results
Purpose: To become proficient at archiving results.

Actions: Archive all results generated during the previous activity.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

the results
Activity 11: Descriptions of transmission statuses
Purpose: To become proficient at understanding the transmission statuses.

Actions: Describe the transmission statuses.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

screen > Descriptions of transmission statuses
Knowledge Check: Result Management

1. Select all of the following tasks that relate to result management:
a) Rerun a test or an exception for a specimen or control.
b) Add a comment to an unreleased result or an exception.
c) Search for or filter data.
d) Release specimen result.
Answer:
2. True or False? You can release a specimen result or a control result from either the Sample Status
screen or the Results screen.
Answer:
3. Which one of the following are valid specimen result flags?

a) EXP
b) CNTL
c) PSHH
d) All of the above
Answer:
Review
1. True or False? Verify the reagent carousel inventory before sample processing is initiated or when
a status indicator is displayed.
Answer:
2. True or False? Before creating a specimen order, you must confirm that the SID is not reused
before previously pending orders are completed or are deleted.
Answer:
3. Which one of the following sample barcode guidelines is incorrect?

a) Printer must have a minimum resolution of 300 dots per inch (DPI).
b) Use labels with an American National Standards Institute (ANSI) grade of A, B, or C.
c) For sample bar code length, a 512 mm label fits a 75 mm sample tube and a 2 mm label fits a
100 mm sample tube.
d) The symbology Code 39 can be used on the Alinity ci-series.
Answer:
4. True or False? To delete a sample result or an exception, begin by clicking Results on the menu
bar.
Answer:
5. From which one of the following screens can you add a comment to an order?
a) Orders
b) Sample Status
c) Both of the above
d) None of the above
Answer:
6. Select all of the following dependencies for sample volume requirements:

a) Sample vessel type
b) Onboard sample storage conditions
c) The ordered assays
d) Pipettor
Answer:
7. True or False? On the Results screen, the operator can view specimen and control results, and
specimen and control exceptions.
Answer:
8. Select all of the following items that may be included in the reagent carousel inventory:
a) Reagents
b) Hydrogen peroxide
c) Onboard solutions and diluents
d) Calibrators and controls
e) Maintenance cartridges
Answer:
9. True or False? You need to view the calibration status of an assay before sample processing is
initiated or when a status indicator is displayed.
Answer:
Module 10: Additional Maintenance
\
Objectives • Perform Weekly, Monthly, Triannual, Quarterly, Semiyearly,

and As- Needed maintenance procedures
• Review and approve the Maintenance Log
• Identify hardware components replaced or cleaned during
Weekly, Monthly, Triannual, Quarterly, Semiyearly or
As-Needed maintenance
Module Topics
A thorough maintenance program minimizes downtime, maintains records for inspection and
accreditation, and maintains system performance to provide optimal test results.
This lesson will provide you with basic knowledge about performing maintenance.
• Perform weekly, monthly, triannual, quarterly, semi-yearly, and as-needed maintenance

procedures.
• Review and approve the maintenance log.
• Identify hardware components replaced or cleaned during weekly, monthly, triannual, quarterly,
semi-yearly, or as-needed maintenance.
Online Operations Manual (Help): Maintenance and diagnostics

subsections; Maintenance and diagnostics, Procedures Log
screen and Maintenance procedure descriptions
Reaction carousel hardware (Alinity c-series)

• Review the parts of the reaction carousel hardware.

Processing modules > Processing module (Alinity c) > Processing
center (Alinity c) > Reaction carousel hardware (Alinity c)
• The following are the hardware components of the Reaction carousel (Alinity c-series):
 Reaction carousel
 Cuvette segments
 Lamp
 Mixers
 Cuvette washer
 ICT unit
 Water bath overflow and waste area
 ICT high-concentration waste area
 High-concentration waste pump
Required Parts
For c-series maintenance the following materials are required
Note: Some of them may be part of the maintenance or acces-

sory kits
 lint free tissue
 Purified water
 o-rings
 syringe seal tips 1 and 2
 Philips screwdriver
 slotted screwdriver
 wrench, 10mm
 absorbent towel
 cotton swabs
 Beaker of 250ml minimum size (for holding syringe and check valve)
 one 1ml syringe
 ICT check valve (if processing module has ICT)

 3mm hex wrench
 15mm wrench
• Three accessory kits are available for the Alinity c-series:
 Accessory kit 1 contains items used for the installation of the system, items used to perform
maintenance and troubleshooting procedures, and some spare accessories for as-needed
component replacement.
 Accessory kit 2 contains some items used during the installation of the system and items used
to perform maintenance and troubleshooting procedures.
 The customer maintenance kit contains all accessories needed to perform scheduled
maintenance for 1 year.
Online Operations Manual (Help): Operations manual reference:

Appendix B (List numbers)-Accessory list numbers (c-series)
Weekly maintenance (Alinity c-series)

• The facilitator will provide the following information for the one weekly maintenance procedure:
 5601 Clean Cuvettes with Detergent A.

dures (Alinity c)
Perform monthly maintenance (Alinity c-series)

• Provide the participants with the following information about the one monthly maintenance
procedure:
 5701: Clean ICT Drain Tip (Alinity c-series)
Required materials:
 Lint-free tissue
 Purified water

dures (Alinity c) >Monthly maintenance
Components of the Sample and reagent syringe area (Alinity c-series)

• The following are the hardware components of the sample and reagent syringe area:
 Sample syringe
 Reagent syringes 1 and 2
Online Operations Manual (Help): use or function > Alinity c hard-

ware overview > Primary components of an Alinity c > Processing
modules > Processing module (Alinity c) > Supply and pump cen-
ter (Alinity c) > Sample and reagent syringe area (Alinity c)
Components of the pump center (Alinity c-series)

• The components of the pump center (Alinity c) are:
 Wash solution pump.
 ICT Reference Solution pump.
 ICT aspiration pump.
 ICT aspiration valve.

Triannual maintenance (Alinity c-series)

5833 Change 1 mL Syringes
• There are seven total 1 mL syringes:
 Two are located in the ICT aspiration pump
 Two are located in the ICT reference solution pump
 Three are located in the wash solution pump.
• All seven are changed if the system is configured to use the ICT module.
• If the system is not configured to use the ICT Module, only the three wash solution 1 mL syringes
are changed.
5834 Check and Change ICT Check Valves

• This Quarterly maintenance procedure is performed to change the ICT aspiration check valve
and to test the functionality of the ICT Reference Solution check valves.
• Materials required:
 Absorbent towel
 ICT check valve
 Beaker that is large enough to hold the 1 mL syringe and the check valve
 Purified water
5835 Check and Clean High-Concentration Waste sensor

• Materials needed:
 Absorbent towels
 0.5% sodium hypochlorite solution
 Beaker that is large enough to hold the high concentration waste sensor
Quarterly maintenance (Alinity c-series)

• There are five quarterly maintenance procedures. The following are the quarterly maintenance
procedures for the Alinity c-series:
 5801 Sample Syringe Maintenance
 5802 Wash Solution Syringe Maintenance
 5803 Reagent Syringe Maintenance
 5806 Change Lamp
 5808 Inspect Wash Cup Tubing
• The facilitator will demonstrate the following information for the seven quarterly maintenance
procedures:
5801 Sample Syringe Maintenance

• Perform this Quarterly maintenance procedure to replace the sample syringe O-ring and sample
syringe seal tips 1 and 2.
• Required materials
 Phillips screwdriver
 Slotted screwdriver
 10 mm wrench
 Absorbent towel
 Sample and Wash Solution Syringe O-ring
 Sample and Wash Solution Syringe Seal Tip #1
 Cotton swabs
5802 Wash Solution Syringe Maintenance

• This Quarterly maintenance procedure is performed to replace the sample syringe O-ring and
sample syringe seal tips 1 and 2. Materials required:
 10 mm wrench
 Absorbent towel
 Sample and Wash Solution Syringe O-ring
 Cotton swabs
5803 Reagent Syringe Maintenance

• This Quarterly maintenance procedure is performed to replace the reagent syringe O-rings and
reagent syringe seal tips 1 and 2. Materials required:
 15 mm wrench
 Absorbent towel
 Reagent Syringe O-ring
 Reagent Syringe Seal Tip #1
 Reagent Syringe Seal Tip #2
 Cotton swabs
 There are two reagent syringes: 1 and 2. Both of these syringes must have quarterly
maintenance procedures completed.
5806 Change Lamp

• Review that this Quarterly maintenance procedure is performed to change the lamp.
 Gloves
 Source lamp, LN 09D4503
 Lint-free tissue (optional)
 Ethanol (optional)
 3mm hex wrench
Caution to wear gloves when performing this procedure. Residual oil from an ungloved hand on
the glass surface of the lamp shortens the lamp life. Also, be careful when removing the lamp
which will be hot. The lamp requires a 5 minute cool-down period before removal and a 30
minute warm-up period after replacement before any assay processing can be performed.
5808 Inspect Wash Cup Tubing

Explain that the operator should inspect the wash cup tubing for any discoloration or obstruction.
If tubing discoloration or obstruction is found, As- Needed procedure 5901 Clean Wash Cups
(c-series) is required to be performed. This customer procedure instructs on decontamination of
the wash cups.

cedure descriptions > Processing module maintenance
As-needed maintenance (Alinity c-series)

• There are seven as-needed maintenance procedures.
5901 Clean Wash Cups (c-series)

Explain this is an As-Needed procedure to clean the processing module wash cups.
5905 Internal Decontamination (c-series) (FSE Logon)

Takes 4 hours and decontaminates the processing module internally.
5906 Clean Sample and Reagent Probes (c-series)

Explain this As-Needed procedure cleans the outside of the sample probe, R1 probe, and R2
probe.
5907 Clean Mixers (c-series)

Explain this As-Needed procedure cleans mixer 1 and mixer 2.
5908 Clean Cuvette Washer Nozzles (c-series)

Explain this As-Needed procedure cleans the cuvette washer nozzles.
5910 Wash Cuvettes (c-series)

Explain this As-Needed procedure washes all cuvettes with Alkaline wash, Acid wash, and water.
5925 Manual RSM Loading Area and Positioners Cleaning (c-series).

• Explain that this procedure is manual cleaning of the RSM loading area, sample positioner, and
reagent positioner..

dures (Alinity c) > As-needed maintenance procedures (Alinity c)
Application Specialist: Pipettor calibrations are no longer under as-needed maintenance but are located
under diagnostic procedures. Diagnostic procedures will be covered in another module.
Components of the Pipetting Hardware (Alinity i-series)

The pipetting hardware for the Alinity i-series is composed of:
 Sample pipettor (S)
 Reagent pipettors (R1 and R2)
 Wash cups (SW, R1W, and R2W)

center (Alinity i) > Pippeting hardware (Alinity i)
Components of Processing Path (Alinity i-series)

The following are the process path components for the Alinity i:
 Vortexers.
 Diverters.
 Liquid waste arm.
 Wash zone assemblies.
 RV access door.
 Process path motor.
 Optics.
 RV unloader.

center (Alinity i) > Processing path (Alinity i)
Weekly Maintenance (Alinity i-series)

• The following are the weekly maintenance procedures for the Alinity i-series:
 2620 Manual Pipettor Probe Cleaning (Alinity i-series)
 2625 Manual Wash Zone Probe Cleaning (Alinity i-series)
 2630 Manual Wash Cup Cleaning (Alinity i-series)
• There are three weekly maintenance procedures.
2620 Manual Pipettor Probe Cleaning

All three pipettors are cleaned with purified water and a lint free cloth to remove salt buildup,
which the facilitator will demonstrate.
 Required materials
 Purified water
 Cotton swabs
2625 Manual Wash Zone Probe Cleaning

 Perform this Weekly maintenance procedure to manually remove the salt buildup from the
wash zone 1 and wash zone 2 probes.
 Purified water
 Cotton swabs
2630 Manual Wash Cup Cleaning

• Perform this Weekly maintenance procedure to remove manually the salt buildup from the
reagent 1, reagent 2, and sample wash cups (including the induction heater wash cup where
applicable) and the wash cup baffles.
 Purified water
 Cotton swabs

dures (i-series) > Weekly maintenance procedures (i-series)
Semiyearly maintenance (Alinity i-series)

2850 Air Filter Cleaning
Explain that this procedure gives instructions for manually cleaning the dust buildup from the
processing module air filters. Rotating between two sets of air filters is recommended
because the filters must be dry when reinstalled.
Required materials
• Two Filters, Processing Center LN 04S6701
• Tap water

diagnostics > Maintenance and diagnostics > Maintenance
procedure descriptions > Processing module maintenance
procedures (i-series) > Semi-yearly maintenance procedure
(i-series)
As-needed maintenance (Alinity i-series)

• Inform there is two as-needed maintenance procedures.
• The facilitator will provide the following information for the as-needed maintenance procedures:
2900 Internal Decontamination (i-series) (CSC Logon)
Review that this procedure is performed to decontaminate the wash buffer fluidics system and takes
2 hours to complete.
2925 Manual RSM Loading Area and Positioners Cleaning.

Explain that this procedure gives instructions for manually cleaning the loading area, reagent
positioner, and sample positioners if a spill occurs.

dures (i-series) > As-needed maintenance procedure (i-series)
Application Specialist: Pipettor calibrations are no longer under as-needed maintenance but are located
under diagnostic procedures. Diagnostic procedures will be covered in another module.
As-needed maintenance (RSM)

• The following is the one maintenance procedure for the RSM:
 2920 Manual RSM Transport Cleaning
Application Specialist: Emphasize that this procedure includes cleaning the bar code reader.
 0.5% sodium hypochlorite solution (This option is only for the RSM transport arm.)
 Quaternary ammonium detergent (This option is only for the RSM transport arm.)
 Isopropyl alcohol (This option is only for the RSM bar code reader mirror.)
 Microfiber cloth (This option is only for the RSM bar code reader mirror.)
 Lint-free tissue
• This procedure gives instructions for manually cleaning the bar code reader mirror and the RSM
transport arm, should errors occur.

cedure descriptions > Reagent and Sample Manager (RSM) main-
tenance procedures > As-needed maintenance procedure (RSM)
> 2920 Manual RSM Transport Cleaning
Unscheduled Cleaning
Some system components may need to be cleaned or decontaminated because of normal use
from daily system operations or because of spills.
These may include:

• external components
• bar code scanner
• monitor
Procedures are available in the Operations Manual.

diagnostics> Maintenance and Diagnostics > Unscheduled clean-
ing
Review the elements of the maintenance procedure log

• The maintenance log indicates the completion status, date and time the procedure is
completed, and the performance of the procedure. Logs are accessed from the Procedures
screen.
• The Maintenance tab displays the maintenance logs. The following list explains the descriptive
elements of the maintenance logs:
 A gray box indicates that the procedure has a status of Scheduled, Pending, Canceled, Not
Performed, or Failed. If the procedure is performed multiple times on the same day, the status
of the last performed procedure is displayed. Tap the box to display the Details for Log flyout.
 A blue box indicates that the procedure has been performed and has a status of
Completed.
 An asterisk (*) within the box indicates that a comment has been entered for the procedure
in the Details for Log flyout.
 A number within the box indicates that the procedure was performed multiple times on the
same day.
 No box indicates that the procedure was not performed or scheduled for that day.
• Demonstrate how to approve a maintenance log. Can only be approved once a month is
completed.
• System Administrator access level is required to approve a maintenance log.
• The diagnostic procedure log contains the same elements as the maintenance procedure log,
diagnostic logs are not approved. Diagnostic procedures are covered in another module.
• The maintenance log will be held on the system for 24 months.
Procedure Map Reference: Maintenance > Approve a mainte-

nance log > Approve a maintenance log

diagnostics> Maintenance and Diagnostics > Procedures Log
screen > Procedures Log screen, Maintenance tab element
descriptions
Maintenance Procedure Statuses
The following are the Maintenance procedure statuses:

 Scheduled A maintenance procedure is scheduled for a future date.
 Pending A maintenance procedure is scheduled for the current date.
 Completed The procedure is completed. For procedures that produce results with pass-or-fail
criteria, all results passed.
 User Canceled Quit is selected before the procedure is completed.
 Failed The procedure generated an error or a failed result.
 <Blank> The procedure has not been performed.
 Running The procedure is in process.
 Waiting user response The procedure in process requires an operator response.
 Not performed The maintenance procedure was not performed on the date due.

diagnostics > Maintenance and diagnostics > Maintenance and
diagnostic procedure statuses
Activity 1: Perform the Alinity i-series weekly maintenance procedure
Purpose: To become proficient at performing weekly maintenance procedures.

Actions: Perform all weekly maintenance procedures using the video in the procedure as a
guide. Add a comment to one of the procedures.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Service, maintenance, and diagnostics

> Maintenance and diagnostics > Maintenance procedure
descriptions > Processing module maintenance procedures
(i-series) > weekly maintenance procedures (i-series)
Activity 2: Perform the Alinity c-series monthly maintenance
Purpose: To become proficient at performing monthly maintenance procedures.

Actions: Perform all monthly maintenance procedures using the video in the procedure as a
guide. Add a comment to one of the procedures.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

(c-series) > Monthly maintenance procedures (c-series)
Activity 3: Perform the Alinity c-series triannual maintenance procedure
Purpose: To become proficient at performing triannual maintenance procedures.

Actions:
Perform the quarterly maintenance procedures using the video in the procedure as a guide.
 5833 Change 1 mL Syringes (c-series). Replace one 1 mL syringe.
 5834 Check and Change ICT Check Valves (c-series). Replace one ICT check valve.
 5835 Check and Clean High-Concentration Waste Sensor (c-series). This procedure is only
performed if the system is installed with a high concentration waste bottle.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

(c-series) > Monthly maintenance procedures (c-series)
Activity 4: Perform the Alinity c-series quarterly maintenance procedure
Purpose: To become proficient at performing quarterly maintenance procedures.

Actions:
Perform the quarterly maintenance procedures using the video in the procedure as a guide.
 5801 Sample Syringe Maintenance (c-series).
 5802 Wash Solution Syringe Maintenance (c-series). Replace the wash solution syringe.
 5803 Reagent Syringe Maintenance (c-series). Replace one reagent syringe.
 5806 Change Lamp (c-series).
 5808 Inspect Wash Cup Tubing (c-series): Inspect the wash cup tubing for any discoloration or
obstructions.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

(c-series) > Quarterly maintenance procedures (c-series)
.
Activity 5: Perform the Alinity c-series weekly maintenance
Purpose: To become proficient at performing weekly maintenance procedures.

Actions: Perform weekly maintenance using the video in the procedure as a guide. Add a
comment to the procedure once it has been performed.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________

(c-series) > weekly maintenance procedures (c-series)
Activity 6: Identify the maintenance completion statues of the Alinity

ci-series
Purpose: To become proficient at identifying the maintenance completion statuses.

Actions: Using the Operations manual (Help), match the maintenance completion statuses with
their definition.
Match the maintenance status with the definition.
Completion Status Definition

___ A - Scheduled 1. The procedure has not been performed
___ B - Pending 2. The procedure generated an error or a

failed result
___ C - Completed 3. A maintenance procedure is scheduled

for a future date
___ D - User Cancelled 4. The procedure is completed. For

procedures that produce results with pass
or fail criteria, all results passed
___ E - Failed 5. A maintenance procedure is scheduled

for the current date
___ F - Blank 6. Quit is selected before the procedure is

completed.
Activity 7: Review the maintenance log
Purpose: To become proficient at reviewing the maintenance log.

Actions: Review the maintenance log. If a previous month's log has not been approved,
approve the log.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Maintenance > Approve a mainte-

nance log > Approve a maintenance log (i-series)
Activity 8:Perform i-series Semi-yearly maintenance
Purpose: To become proficient at performing semi-yearly maintenance procedures.

Actions: Perform semi-yearly maintenance using the video in the procedure as a guide. Add a
comment to the procedure once it has been performed.

(i-series) > Semi-yearly maintenance procedures (i-series)
Review
1. Select all of the valid Alinity ci-series maintenance statuses:

a) Scheduled
b) Waiting user response
c) Drying
d) Failed
Answer:
2. True or false? The Maintenance tab includes scheduled and as-needed maintenance cleaning
procedures to perform.
Answer:
3. In which one of the following time frames do you approve a maintenance log?
a) Weekly
b) Annually
c) Monthly
Answer:
4. True or false? Procedure 2920 - Manual RSM transport cleaning - includes cleaning the bar code
reader mirror.
Answer:
5. To view or perform a maintenance procedure begin by selecting the ____in the Menu Bar.
a) Maintenance icon
b) Procedures icon
c) Orders icon
d) System Button
Answer:
6. Only scheduled maintenance procedures can be displayed and performed from the
procedures screen.
a) True
b) False
Answer:
7. Identify all of the benefits of a thorough service, maintenance, and diagnostic program. (Select
all that apply)
a) a. Maintenance records for inspection and accreditation
b) b. Archives patient results
c) c. Minimizes downtime
d) d. Maintains system performance to provide optimal test results
Answer:
\
Module 11: Common Errors and

Troubleshooting
Objectives • Describe the troubleshooting process

• Describe and use the Alert Center
• View message codes
• View the probable cause and corrective action for a
message
• Describe what the operator can view and perform on the
System Logs screen
• View Observed problems
• View the probable cause and corrective action for a
message
Module Topics
Using a systematic approach to define symptoms and identify problems
allows you to implement solutions. Operational problems with the instrument
are characterized by symptoms. Troubleshooting tools, references, and
suggested techniques help to trace and resolve the symptom to one or more
root causes. To identify and resolve operational problems, become
thoroughly familiar with normal system operation. Effective troubleshooting
requires a logical step-by-step approach to resolve problems.
This lesson will provide you with basic knowledge about how to approach and
perform effective troubleshooting.
• System troubleshooting
• System diagnostics
• Cycle power, start, pause and stop
• Miscellaneous corrective action procedures
System Troubleshooting
Problems with the Alinity ci-series are characterized by identifiable symptoms. Troubleshooting tools
and methods help trace the symptoms to one or more root causes. After determining the cause of
the problems, perform corrective actions to resolve system issues.
The facilitator will review and demonstrate how to approach and perform effective troubleshooting,
including:
 Approach to troubleshooting
 Alert Center, including viewing the probable cause and corrective action for a message
 Message codes
 System Logs screen
 Fundamentals of Assay Troubleshooting CBT
 Observed problems
Approach to troubleshooting
Review each step of the five-step model:
 Observe and recognize symptoms
 Categorize symptoms
 Isolate the root cause and create a plan of action
 Resolve the problem
 Verify that the resolution worked
Application Specialist: Emphasize the importance of using Active Sense Technologies (AST).
 Review that when working with a customer, on-site or on the phone, it is important to take
customer’s time into consideration.
Online Operations Manual (Help): Troubleshooting>Approach to

troubleshooting
Alert center
• In the Alert Center flyout, they can:
 View the last 25 alerts and notifications, sorted based on newest to oldest and are displayed
in the Alert Center until they are cleared or until 25 are reached. After 25 messages are
reached, they will follow a first-in, first-out method of deletion.
 A red triangle (alert) badge indicates system problems that require immediate attention.
 An amber circle (notification) badge indicates system problems that require attention
that is not immediate.
 Application Specialist: Emphasize that correct term is now message code and not error
code.
 View the probable cause and corrective action for a message by tapping ?Message.
 View additional messages that are associated with a message.
 Delete a message from the Alert Center.
 Clear all messages
Online Operations Manual (Help): Troubleshooting>Alert Center

flyout
Message codes
 Point out the different sections of message codes.

 State that the probable causes are listed from most likely to least likely in occurrence.
 Review the importance of following and completing each probable cause and corrective
action in the order listed unless there are obvious reasons for the problem to exist. An
example of this would be an observed tubing is disconnected and liquid is leaking.
Online Operations Manual (Help): Troubleshooting> Message

codes
System Logs Screen
• Explain that the operator can view the following logs on the System Logs screen:
 All messages: A record of all system messages that can be used to troubleshoot problems
associated with system performance and results reporting.
 Alerts and notifications: A record of noncritical messages.
 Informational: A record of informational messages.
 Inventory: A record of supply-related messages.
 User access: A record of new users that have been created, edits to user data, and logon
and logoff events.
 Configuration: A record of changes to configuration.
 Interface: A record of host interface communication messages.

 Abbott Mail: A record of Abbott Mail activities and status messages
• The operator can perform the following functions on the System Logs screen:
 Print a Log
 Search for specific log data

Application Specialist: The predictive alerts will be handled by internal sources (POM, etc.)
System log can hold up to 120,000 messages.
Online Operations Manual (Help): Troubleshooting>System Logs

screen
Observed problems
• Point out the different sections of observed problems.
• Remind that the probable causes are listed from most likely to least likely in occurrence
• Review the importance of following and completing each probably cause and corrective
action in the order listed unless there are obvious reasons for the problem to exist. An example of
this would be an observed tubing is disconnected and liquid is leaking.
Application Specialist: Emphasize procedure for how to handle a maintenance procedure
failing and a procedure item remaining in the reagent carousel.
For Remote Support Employees: Review that sample probe issues recommends that if a sample
or reagent probe may be clogged by particulate matter, the corrective action is to use a
cleaning wire to dislodge particulate matter.
Online Operations Manual (Help): Troubleshooting > Observed

problems

problems > A procedure failed and a procedure item remained in
the reagent carousel
Activity 1: Order the five steps in the approach to troubleshooting
Purpose: To become proficient at understanding the five steps in troubleshooting.

Actions: Put in order the five steps in the troubleshooting approach.
Put in order the five steps in the troubleshooting approach:
___ A - Categorize symptoms
___ B - Observe and recognize symptoms
___ C - Resolve the problem
___ D - Isolate the root cause and create a plan of action
___ E - Verify that the resolution worked.
Online Operations Manual (Help): Troubleshooting> Approach to

troubleshooting
Activity 2: View a message code and list probable cause and corrective
action
Purpose: To become proficient at understanding message codes, causes, and corrective

actions.
Actions: Using the list of message codes, view a message code and list the probable cause and
steps to correct the problem.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Online Operations Manual (Help): Troubleshooting> Message

codes
Activity 3: Use the Alert Center to view probable cause and corrective
action procedure
Purpose: To become proficient at using the Alert Center to view causes and corrective actions.
Actions: Using the Alert Center, list the steps required to identify probable cause and steps to
correct the problem.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Procedure Map Reference: Troubleshooting > Alert Center flyout >

View the probable cause and corrective action for a message
Activity 4: View an observed problem and list probable cause and

correction action
Purpose: To become proficient at recognizing observed problems

Actions: Using the Operations manual (Help), view an observed problem and list the probable
cause and steps to correct the problem.

problems
Activity 5: List the functions an operator can perform from the System Logs
screen
Purpose: To become familiar with the System logs screen

Actions: List the functions you can perform from the Systems Logs screen.
Online Operations Manual (Help): Troubleshooting > System logs

screen
Knowledge Check: System Troubleshooting
1. Select all of the following that point to system problems:
a) Flickering monitor
b) Sudden or unusual noise
c) Trend in controls
d) Message codes
Answer:
2. True or False? The Alert Center flyout displays alert and notification messages for system problems
that require attention.
Answer:
3. Which one of the following actions do you take to delete a message from the Alert Center?
a) View calibration guidelines.
b) Tap message to delete, then tap the Close button (x) in the upper right corner of the
message box.
c) Delete the message from the System Logs screen.
d) There is no way to delete messages from the Alert Center.
Answer:
System Diagnostics
Diagnostics are performed on an as-needed basis. They can be used to confirm the status of
assemblies and mechanisms, and help identify and resolve operational problems.
The Procedures screen displays the diagnostics procedures. After initiating a procedure, follow
the step-by-step instructions through the procedure to completion.
The diagnostics log indicates the completion status, date and time the procedure is completed,
and the performance of the procedure.
A thorough diagnostics program gives the operator the tools to identify and resolve operational
problems and verify that a problem has been resolved.
This lesson will provide you with basic knowledge about performing diagnostics.
Objectives
• Use diagnostic procedures to resolve system issues
Automatic processing module activities

Periodically, system operations occur automatically to maintain the optimal performance and
condition of the system.
Review each of the following automated activities using the operations manual reference below
 System flush (c-series)
 System flush (i-series)
 System prime (i-series)
 Processing module wash (c-series)
 Automatic rotation of reagent carousel (c-series)
Online Operations Manual (Help):Use or function > Automatic pro-

cessing module activity
Diagnostic procedure description
Diagnostic procedures are module specific. The type of module determines the categories and
procedures that are available.
• Diagnostic procedures can be used to:

 Identify a problem.
 Help resolve the problem.
 Verify that the problem has been resolved.
 During component replacement, verify the component has been replaced correctly.
• Diagnostic procedures are grouped first by module type and then by category. The type of
module determines the categories and procedures that are available. Each category is
represented by a tab on the right side of the Diagnostics tab on the Procedures screen.
• The All tab displays all procedures for the selected module. Each additional tab represents a
functional subsection of the system.
• Diagnostic categories include:
 Optics
 Pipettors
 Fluidics-wash
 Temperature
 RV loader (i-series)
 Process path (i-series)
 Sample manager
 Reagent manager
 Module
 Utilities (i-series)
 Reaction mechanisms (c-series)
 ICT (c-series).
Activity 7: Identify the diagnostic completion statuses of the Alinity
ci-series System
Purpose: To become proficient at identifying the diagnostics complete statuses if the ci-series.
Actions: Match the diagnostic completion status with the definition.
Diagnostic completion Definition

status
___ A - Completed 1. Indicates the procedure in process
requires operator input.
___ B - User Canceled 2. Indicates that the procedure is

completed. For procedures that produce
results with pass-or-fail criteria, all results
passed.
___ C - Failed 3. Indicates the procedure has produced an

error or a failed result.
___ D - Running 4. Indicates that Quit is selected before the

procedure is completed.
___ E - Waiting user 5. Indicates the procedure is in process.

response

> Maintenance and diagnostics > Maintenance and diagnostic
procedure statuses
Activity 8: Perform a diagnostic procedure
Purpose: To become proficient at performing a diagnostic procedure.

Application specialist: Recommended to perform sample pipettor calibration for the c-series
and reagent pipettor calibration for the i-series
• For i-series pipettor calibration, choose the option to do both a straightness check and
calibration.
• Recommend to do Reagent transport calibration for RSM.
• Procedures will indicate if tap water or distilled water should be used when performing
procedures.
Actions: Perform a diagnostic procedure.
 Begin the procedure.
 Leave the procedure while it is in process.
 Return to the procedure and complete the procedure.
Procedure Map Reference: Maintenance > Perform maintenance

> Perform a maintenance procedure or a diagnostic procedure
Activity 9: Add a comment to a diagnostic procedure
Purpose: To become proficient at adding a comment to a diagnostic procedure.

Actions: Add a comment to a diagnostic procedure.
Procedure Map Reference: Maintenance > Document comments

to a procedure > Add a comment to a maintenance procedure or
a diagnostic procedure
Activity 10: Review the diagnostic log
Purpose: To become proficient at reviewing the diagnostic log.

Actions: Review the diagnostic log.

diagnostics > Maintenance and diagnostics > Procedures Log
screen
Knowledge Check: System Diagnostics

1. True or False? To access Diagnostics, you must first tap the Procedures tab and then tap the
Diagnostics tab.
Answer:
2. Select all of the following questions to address when adding a comment to a maintenance
procedure or a diagnostic procedure:
a) Why a procedure failed or was repeated.
b) Why a maintenance procedure was not completed when scheduled.
c) Why a nonscheduled procedure was performed.
d) All of the above
Answer:
3. True or False? the reagent and sample manager (RSM) has separate diagnostic procedures from
the processing module.
Answer:
Miscellaneous Corrective Action Procedures
After completing this lesson, you should be able to identify and perform the miscellaneous
corrective action procedures.
The facilitator will review miscellaneous corrective action procedures, including:
• Remove racks from the sample positioners.
• Empty the bulk solution reservoirs (c-series).
• Empty the bulk solution reservoirs (i-series).
• Empty the diluted wash buffer reservoir (i-series).
• Application Specialist: Manually unload a cartridge or rack from the reagent carousel
Remove racks from the sample positioners
Perform this procedure to remove sample and vial racks from the inner and outer sample positioners
after one of the following situations occurs:
• Power to the processing module or the Reagent and Sample Manager (RSM) is interrupted.
• An error has caused the instrument status of the processing module or the RSM to transition
unexpectedly to Stopped.
• A maintenance procedure or a diagnostic procedure has caused the instrument status of the
processing module or the RSM to transition unexpectedly to Stopped.
.
Procedure Map Reference: Troubleshooting > Reagent and Sam-

ple Manager (RSM) corrective action procedure > Remove racks
from the sample positioners
Demonstrate how to empty the bulk solution reservoirs (c-series)

• Identify the tubing connections
• Demonstrate how to empty the bulk solution reservoirs (c-series).
Empty the bulk solution reservoirs (i-series)
• Use the animations during the demonstration.
• Identify that this procedure is similar to the c-series.
• Identify the tubing connections.
Procedure Map Reference: Troubleshooting > Processing module

corrective action procedures > Empty the bulk solution reservoirs
(i-series)
Empty the diluted wash buffer reservoir (i-series)

The facilitator will demonstrate how to empty the diluted wash buffer reservoir (i-series).
• Explain that they will need the lock ring release tool to perform this procedure.

corrective action procedures > Empty the diluted wash buffer res-
ervoir (i-series)
Manually unload a cartridge or rack from the reagent carousel

• Review that a Phillips screwdriver and the cartridge removal tool will be needed
• Demonstrate steps of manually unload a cartridge or rack from the reagent carousel.
Procedure Map Reference: Troubleshooting-Miscellaneous correc-

tive action procedures-Manually unload a cartridge or rack from
the reagent carousel.
Activity 11: Remove racks from the sample positioners
Purpose: To become proficient at removing racks from the sample positioners.

Actions: Remove racks from the sample positioners.
Procedure Map Reference: Troubleshooting > Reagent and Sam-

ple Manager (RSM) corrective action procedure > Remove racks
from the sample positioners
Activity 12: Empty a bulk solution reservoir (c-series)
Purpose: To become proficient at emptying bulk solution reservoirs.

Actions: Remove a bulk solution reservoir.

(c-series)
Activity 13: Empty a bulk solution reservoir (i-series)
Purpose: To become proficient at emptying bulk solution reservoirs.

Actions: Remove a bulk solution reservoir.

(i-series)
Application specialist Activity: Item remained in Reagent carousel
Purpose: To become proficient at what to do if a maintenance activity fails.

Actions: Start I-side daily maintenance, when in process, confirm the procedure key is off and
open front or back cover. This will cause the maintenance procedure to fail. Note that
maintenance cartridge is still in regent carousel. Follow instructions in operations manual
reference below to resolve.
Discussion: Discuss any questions or issues that may arise from the activity
Online Operations Manual (Help): Troubleshooting> Observed

problems> Processing module observed problems> A procedure
failed and a procedure item remained in the reagent carousel
Knowledge Check: Miscellaneous Corrective Action
1. Select all of the following situations that prompt you to remove sample and vial racks from the
inner and outer sample positioners:
a) Power to the processing module or the reagent and sample manager (RSM) is interrupted.
b) An error has caused the instrument status of the processing module or the RSM to transition
unexpectedly to Stopped.
c) An error has caused the instrument status of the RSM to transition to Paused.
d) A maintenance procedure or a diagnostic procedure has caused the instrument status of
the processing module or the RSM to transition unexpectedly to Stopped.
Answer:
2. Which one of the following steps do you complete first when emptying the bulk solution reservoir
(c-series)?
a) Start the processing module
b) Tighten the bulk solution level sensor cap
c) Open the bulk solution door and pull out the reservoir tray
d) Empty the reservoir and rinse it with purified water
Answer:
Review
1. Select all of the following steps required in the troubleshooting approach.

a) Categorize symptoms.
b) Observe and recognize symptoms.
c) Resolve the problem.
d) Isolate the root cause and create a plan of action.
e) Verify that the resolution worked.
f) All of the above
Answer:
2. True or False? If an emergency situation occurs, locate the main power breaker on the rear of
the System Control Module (SCM) and all processing modules and switch them to the OFF/O
position. Then unplug the power connector from the power supply.
Answer:
3. Which one of the following tabs on the System Logs screen would you use to display alert,
critical, and notification message codes?
a) Host tab.
b) Inventory tab.
c) Notifications/Alerts tab.
d) Abbott Mail tab.
Answer:
4. True or False? You can view the probable cause and corrective action for a message using the
Alert Center flyout.
Answer:
5. True or False? When performing diagnostics, the Diagnostics tab displays procedures that can be
used to confirm the status of assemblies and mechanisms to help identify and resolve
operational problems.
Answer:
6. Select all of the following questions to address when adding a comment to a maintenance
procedure or a diagnostic procedure:
a) Why a procedure failed or was repeated.
b) Why a maintenance procedure was not completed when scheduled.
c) Why a nonscheduled procedure was performed.
d) All of the above
Answer:
7. True or False? Fluidic subsystems are hardware components that control the precision and
accuracy of liquid level sensing, aspiration, and dispense.
Answer:
8. Corrective actions that may involve hazardous activity include:

a) The replacement of system probes.
b) The use of reagents, calibrators, controls, and specimens.
c) The removal of physical obstructions.
d) The removal of system waste.
e) All of the above
Answer:
9. True or False? You perform the Empty the diluted wash buffer (i-series) procedure to remove the
diluted wash buffer from the diluted wash buffer reservoir when the wash buffer expires.
Answer:
Module 12: Basic Component Replacement
\
Module 12: Basic Component

Replacement
Objectives • View procedures for component replacement

• Replacing components (c-series).
• Replacing components (i-series)
Module Topics
System components may need to be replaced due to normal wear from daily operations or
troubleshooting. In this module, you will explore the:
• Component replacement (c-series).
• Component replacement (i-series).

diagnostics > Component replacement > Supply and pump cen-
ter component replacement (c-series)
Component replacement (c-series)

This lesson will provide you with basic information and instructions to replace components on the
c-series processing center.
The facilitator will identify the location of the replaceable components and describe replacing
c-series components, including:
 Processing center component replacement (c-series) locations.
 Replace the sample probe.
 Replace the cuvette dry tip.
 Replace the ICT module or the ICT probe.
 Supply and pump center component replacement locations.
Replacing components due to normal wear from daily operations helps maintain system
performance to provide optimal test results.
When replacing components, the following general safety precautions should be observed:
Replaced components and materials used during component replacement (for example,
absorbent towels or tissues) should be disposed of in accordance with the waste disposal
procedures in your laboratory.
 When drips or leaks occur, clean up the liquid and decontaminate the surface if necessary.
 Always observe all warnings and cautions in the operations manual associated with the
particular component being replaced.
Always observe all warnings and cautions in the operations manual associated with the
Processing center component replacement (c-series) locations

 Review the processing center components graphic.
 That the procedure will inform if the procedure key is required to be in the On position.
 Remind learner the lamp was already replaced during quarterly maintenance.
 The components being replaced in training are the more common components that will
need replacement. Other components not replaced during training are similar to these
components.
 Read and follow all warnings and cautions.

> Component replacement > Processing center component
replacement (c-series)
The replaceable components for the processing center are:
 Sample Probe
 Sample Probe Tubing
 Reagent Probes
 Reagent Probe Tubings
 Mixers
 ICT module
 ICT probe
 Lamp
 Cuvette dry tip
 Cuvette segment.
Note: Always review the operations manual procedures for precautions and verification procedures
that must be performed after component replacement.
Replace the sample probe (c-series)

• When removing the sample probe, loosen (but do not remove) the probe screw and the screw
securing the sample probe ground wire.
• Be careful to not flare or stretch the sample probe tubing when installing the new sample probe.
• Ensure the sample pipettor cover is not pinching the sample probe tubing and is secured
completely for correct level sensing.
Note: Recording and tracking the date of the sample probe

installation is recommended to ensure that the sample
probe is not used for longer than the following intervals:
 Six months for systems that use whole blood assays
 One year for systems that do not use whole blood assays
Application specialist: Recommend that we set up a user defined

maintenance procedure for customers to track. Set-up will be
discussed in configuration section.
Procedure Map Reference: Troubleshooting > Replace compo-

nents > c-series > Processing center component replacement
(c-series) > Replace the sample probe (c-series)
Replace the cuvette dry tip (c-series)

• Ensure to wear gloves to perform the following steps. Residual oil from an ungloved hand
interferes with the appropriate drying function of the cuvette dry tip.
• The procedure key must be in the On position.
• Review that a metric ruler is needed to align the cuvette tip replacement

(c-series) > Replace the cuvette dry tip (c-series)
Replace the bulk solution level sensor (c-series)
This procedure directs the user through how to replace the level sensor for Acid Wash, Alkaline Wash
or ICT Reference Solutions.

ter component replacement (c-series) > Replace the bulk solution
level sensor (c-series)
Replace the ICT module or the ICT probe (c-series)

When the ICT module is replaced, the (c-series) processing module tracks and maintains a
record of the serial number, the expiration date, the warranty sample count, and the warranty
days on the system. The warranty for the ICT module is 20,000 samples or 3 months after
installation, whichever occurs first.

(c-series) > Replace the ICT module or the ICT probe (c-series)
Replace the mixers

• Review that the procedure key needs to be in the on position
• Review that for mixer 1 you access from the front of the processing module and for mixer 2
access from the back of the processing module.
Procedure Map Reference: Troubleshooting>Replace compo-

nents>c-series>Processing center component replacement
(c-series)>Replace the mixer
Supply and pump center component replacement (c-series) locations

• Review the supply and pump center component (c-series) graphic.

ter component replacement (c-series)
The replaceable components for the supply and pump center (c-series) are:
1. 1ml syringes
2. Check valves
3. Wash solution syringe O-ring and seal tips 1 and 2
4. Reagent syringe O-ring and seal tips 1 and 2
5. Sample syringe O-ring and seal tips 1 and 2
Activity 1: Replace the bulk solution level sensor (c-series)
Purpose: To become proficient at replacing bulk solution level sensor.

Actions: Remove and replace the bulk solution level sensor (c-series).
Activity 2: Replace the sample probe (c-series)
Purpose: To become proficient at replacing sample probes.

Actions: Remove and replace the sample probe (c-series).

(c-series) > Replace the sample probe (c-series)
Activity 3: Replace the cuvette dry tip (c-series)
Purpose: To become proficient at replacing cuvette tips.

Actions: Remove and replace the cuvette dry tip (c-series).

(c-series) > Replace the cuvette dry tip (c-series)
Application Specialist Activity: Replace a mixer
Purpose: To become proficient at replacing mixers

Actions: Remove and replace a mixer (c-series).
Knowledge Check: Component Replacement

1. Select all of the correct time intervals for the sample probe usage following replacement
a) Three years.
b) Six months for systems generating results for whole blood assays.
c) One hour.
d) One year for systems not generating results for whole blood assays.
Answer:
2. Select the materials required to replace the cuvette dry tip (c-series):
a) You do not need to replace the cuvette dry tip.
b) Gloves.
c) Cotton swabs.
d) Metric ruler.
Answer:
3. True or False? The c-series processing module tracks and maintains a record of the serial number,
the expiration date, the warranty sample count, and the warranty days for the ICT module on
the system.
Answer:
Component replacement (i-series)

Replacing components due to normal wear from daily operations helps maintain the system
performance to provide optimal test results.
When replacing components, the following general safety precautions should be observed:
• Replaced components and materials used during component replacement (for example,
absorbent towels or tissues) should be disposed of in accordance with the waste disposal
procedures in your laboratory.
• When drips or leaks occur, clean up the liquid and decontaminate the surface if necessary.
Always observe all warnings and cautions in the operations manual associated with the
This lesson will provide you with basic information and instructions for replacing components on
the i-series processing center.
The facilitator will identify the location of the replaceable components and describe replacing
i-series components, including:
Processing center component replacement.

• Remove and replace the process path light cover
• Replace a sample or reagent pipettor probe.
• Replace the wash zone probes.
• Replace the liquid waste arm probe
Supply center component replacement.

• Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer.
• Replace the diluted wash buffer level sensor.
Processing center component replacement (i-series)

Review the processing center components (i-series) graphic.
• The procedure will inform if the procedure key is required to be in the On position.
• Read and follow all warnings and cautions.
• Component replacement may expose the operator to potentially hazardous conditions.
Untrained operators must not perform component replacement.

diagnostics > Component replacement > Processing center com-
ponent replacement (i-series)
The replaceable components for the processing center are:

 Sample Pipettor Probe
 Wash Zone probes
 Reagent Pipettor Probes
 Liquid waste arm probe
Remove and replace the process path light cover (i-series)

• The procedure key must be in the On position. If the procedure key is not in the On position, the
pipettor probe will fall into the wash cup when the processing cover is open.
• Review that there are two configurations that could be installed on the system, determine which
configuration is on the system and refer to the appropriate removal and replacement
procedure. Review the procedures for both configurations of light covers and verification
procedures to be performed.
• Incorrect placement of the light shield could cause unload diverter errors and cause processing
module not to transition into a running status.

nents > i-series > Processing center component replacement
(i-series) > Remove and replace the process path light cover
(i-series)
Replace a sample or reagent pipettor probe (i-series)

• The procedure key must be in the On position. If the procedure key is not in the On position, the
pipettor probe will fall into the wash cup when the processing cover is open, and it will be
difficult to replace.
• Explain that when connecting the probe tubing, align the probe tubing on the probe and rotate
the probe fitting.

(i-series) > Replace a sample or reagent pipettor probe (i-series)
Replace the wash zone probes (i-series)
• Before disconnecting the black wash zone monitor housing from the blue probe housing, you
need to invert the probe block assembly so the wash zone probes are facing down. If separated
with the probes facing up, the probes will fall out of the assembly.
• Direct participants to align the L-shaped cutout of the wash zone monitor housing (black) with
the L-shaped cutout of the probe housing. Guide the wash zone probes into the probe channel
in the wash zone monitor housing.

(i-series) > Replace the wash zone probes (i-series)
Supply center component replacement (i-series)
Replacement of the components for the supply and pump center was performed during
maintenance. The supply center has two areas that have replaceable components.
Bulk solution reservoir components (i-series):
 Concentrated Wash Buffer level sensor.

 Pre-Trigger Solution level sensor.
 Trigger Solution level sensor.
Pump drawer component (i-series):
 Diluted wash buffer level sensor.
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer (i-series)
• The level sensors are the same part for both Alinity i-series and Alinity c-series. The removal and
replacement procedure is similar.
• The tubing connection is specific to this procedure. Follow the instructions exactly for the correct
orientation.

nents > i-series > Supply center component replacement (i-series) >
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or
Concentrated Wash Buffer (i-series)
Replace the diluted wash buffer level sensor (i-series)

• Explain that the lock ring release tool is required to remove the tubing. The tool can be found in
the maintenance kit.
• Explain that depending on the instrument configuration, a ground strap may need to be
removed from the rear fluidics panel before it can be removed. Replace the ground strap when
the panel is replaced.

nents > i-series > Supply center component replacement (i-series) >
Replace the diluted wash buffer level sensor (i-series)
Optional component replacement

• Replace the external waste pump

diagnostics > component replacement > optional component
replacement > replace the external waste pump
Activity 1: Remove and replace the process path light cover (i-series)
Purpose: Become proficient at removing and replace the process path light cover (i-series)
Actions: Remove and replace the process path light cover (i-series).

(i-series) > Remove and replace the process path light cover
(i-series)
Activity 2: Replace a sample or reagent pipettor probe (i-series)
Purpose: Become proficient at removing and replace a sample or reagent pipettor probe
(i-series)
Actions: Remove and replace a sample or reagent pipettor probe (i-series).

(i-series) > Replace a sample or reagent pipettor probe (i-series)
Activity 3: Replace the wash zone probes (i-series)
Purpose: Become proficient at replacing the wash zone probes (i-series)

Actions: Remove and replace wash zone probes (i-series).

Activity 4: Replace the level sensor for Pre-Trigger Solution, Trigger Solution,
or Concentrated Wash Buffer (i-series)
Purpose: Become proficient at replacing the level sensor for Pre-Trigger Solution, Trigger Solution,
or Concentrated Wash Buffer (i-series)
Actions: Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer (i-series).

Activity 5: Replace the diluted wash buffer level sensor (i-series)
Purpose: Become proficient at replace the diluted wash buffer level sensor (i-series)
Actions: Replace the diluted wash buffer level sensor (i-series)

Review
1. True or False? Component replacement involves three key tasks: removal of the old component,
installation of the new component, and verification of the new component.
Answer:
2. Select all of the following cautionary statements you need to remember when performing any
(c-series) or (i-series) component replacement procedures:
a) CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious
material.
b) CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
c) CAUTION: Electric Shock Hazard.
d) CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
Answer:
3. Select all of the following precautions when working with tubing:

a) Do not flare or stretch the tubing.
b) The tubing needs to fit firmly on the sample probe, but must not be pushed past the bend of
the probe so that the tubing does not become too loose.
c) Replace tubing every day.
d) If the tubing is loose or if the probe has been replaced several times by using the same
tubing, replacing the sample probe tubing is recommended.
Answer:
Module 13: Configuration Options
\
Objectives: After completing this lesson, you should be able to perform con-
figuration tasks from the:
• Configure screen, General tab
• Configure screen, Computer tab
• Configure screen, Assay tab
• Configure screen, Maintenance and Diagnostics tab
Module Topics
For optimal system performance, the Alinity ci-series should be configured to meet your individual
laboratory requirements. This training module will focus on common configuration procedures.

• System Configuration

cial requirements > System configuration
Configure the System

Configuration settings define the information that the Alinity ci-series system needs to meet
laboratory specific requirements.
System configuration is performed following system installation and can be changed at any time.
This lesson will provide you with basic knowledge about configuring the Alinity ci-series system.
After completing this lesson, you should be able to perform configuration tasks from the:
• Configure screen, General tab.
• Configure screen, Computer tab.
• Configure screen, Assay tab.
• Configure screen, Maintenance and Diagnostics tab.
Configure Screen, General Tab
• Application specialist: The facilitator will go through each of the configuration screens in detail.

cial requirements > System configuration > Configure screen, Gen-
eral tab.
There are eight screens that can be accessed from the General tab:
• Users
• User Profile
• Modules
• Printers
• Bar Codes
• Reagents and Supplies
• Reports
• Abbott Mail
Users Screen
• On the Users screen, the operator can view the following information for users that have been
created on the system:
 Operator ID
 First and last names
 Access level
 Status
 Date on which a user was created

 The system administrator can perform the following functions:
 Create new users.
 Edit a user name, the access level, and the status.
 Reset a user PIN.
 Import and export user data
Online Operations Manual (Help): Installation Procedures and spe-

cial requirement>System configuration>Configuration screen,
General tab>Users screen
Demonstrate how to create a new user.
The software is configured to require a PIN for general operator logon; however, this requirement
can be disabled. If this setting is disabled, the field for a PIN for each user will no longer have a red
asterisk next to it.

Setup > Configure general settings > Users > Create a new user

Computer tab > General Settings screen > Configure general set-
tings
User Profile Screen
On the User Profile screen, the operator can perform the following functions:
 Configure a personal display theme.
 Change a personal user PIN. General operators can change their personal user PINS but
cannot change the user PINs of other users.

General tab>User Profile screen
Modules Screen
On the Modules screen, the operator can view the following information:
 Serial numbers for each processing module and the Reagent and Sample Manager (RSM).
 The number of assigned reagent carousel positions for onboard calibrators and controls
 The quality control shift start time
 The location and number of priority sections
 Specific parameters for each processing module and the RSM.
 Instrument test cycle counts
For i-series module, the stat protocol percentage can be set. Options follow for every 10 positions
on the processing carousel:
 None - no positions are available for STAT testing
 10% - 1 position is available for STAT testing
 20% - (Default) 2 positions are available for STAT testing
 30% - 3 positions are available for STAT testing

General tab>Modules screen
Printer Screen
The system administrator can perform the following functions:
 Add a new printer.

 Verify a new printer.
 Change the configuration of an existing printer.
 Configure a printer as the default.
 Access the printer queue.
 Remove a configured printer from the software.

General tab>Printers screen
Add a Printer
Demonstrate how to add a printer.

and specifications > Specifications and requirements > Computer
and interface specifications

Setup > Configure general settings > Printers > Add a printer
Verify a Printer
Demonstrate how to verify a printer.

To verify the printer you must manually compare the printout from the printer to what is on the
screen. You are looking for missing characters, things being cut off, etc.
There is a complete list of reports that can be printed from each screen in the operations manual
under Print Flyout, see online Operations Manual reference below.
Online Operations Manual (Help):

Operating Instructions > Print Flyout

Setup > Configure general settings > Printers > Verify a printer
Bar Codes
• On the Bar Codes screen, the operator can view the following information:
 Sample bar code types that are enabled or are disabled
 Configuration settings for each bar code type
• The system administrator can perform the following functions:
 Enable or disable sample bar code types.
 Configure checksums.
 Configure the transmission of checksum digits to the user interface (UI) computer.
 Configure the transmission of start and stop characters to the UI computer.
 Configure primary and secondary code lengths.

General tab>Bar Codes screen
Reagents and Supplies

• Configure the ability to run controls for each reagent lot or reagent cartridge.
Note: If the control option is changed, the control option does not change in the assay parameters
for individual assays that are currently installed. This change affects only the new assay files
that are installed or are imported.
• Configure the default reagent low alert for all immunoassay reagents and clinical chemistry
reagents.
• Configure the default calibration interval.
• Configure the ability to run reagents that are beyond the reagent onboard stability expiration
and the reagent lot expiration.
• Configure reagent low alert settings for individual reagents.
• Configure low alert settings for bulk solutions.
• Configure the ability to use supplies that are beyond the supply stability expiration and the
supply lot expiration.
• The system administrator can also perform the following functions only for c-series modules:
 Configure the ability to run calibrations for each reagent lot or reagent cartridge.
 Configure low alert settings for onboard diluents and onboard solutions.
 Configure which module in a multimodule system uses Detergent B.

General tab>Reagents and Supplies screen
Reports
• On the Reports screen, the operator can view settings for automatically generated reports.
• The operator can configure print screen output options.
• The supervisor can configure settings for automatically generated reports.
• The system administrator can configure a facility name to display on each report.

General tab>Reports screen
Abbott Mail
On the Abbott Mail screen, the operator can view the Abbott Mail download options.
 Enable or disable Abbott Mail items that can be downloaded automatically.
 Assay files
 Assay Inserts
 Assay Insert Notifications
 Calibrator data
 Configure the download language for the Abbott Mail documentation

General tab>Abbottmail screen
Application Specialist General Configuration Activity
Purpose: To be proficient in configuring systems
Actions: Complete the activity provide by the facilitator.
1. True or False. When creating a new user, a PIN is required
2. What are the four options that can be automatically downloaded for Abbottlink (if standalone IA
will only be three)?
3. Where is the setting to automatically reposition samples for retesting located?
4. True or False. Once you create a new user, you can delete that user profile at a later time
5. Where do I change the print screen output destination? What does print screen output
destination mean?
6. True or False. After you install a new printer, you must manually verify that printer or it will not show
as available when trying to print.
7. Which barcode type cannot be disabled?
8. What are the steps to print a 1D barcode for a reagent or diluent (clinical chemistry only)?
9. Where can I edit the module name?
a. What information might I suggest a customer put in this field?
10. Where do you configure the number of positions for onboard QC/Cal racks?
11. Where can you locate the general setting for the calibration interval that applies to all assays
installed on a system (note: this will not show up on a standalone c-system)?
Discussion: Discuss the activity and answer any questions the participants may have.
Configure screen, Computer tab
Provide a brief description of the items that can be configured from the Computer tab.

Computer tab
There are 11 screens that can be accessed from the Computer tab:
• General Settings
• Audio Settings
• Host Setup
• HL7 Communication
• ASTM Communication
• LAS Communication
• Shortcuts
• Automatic Backup
• Alinity PRO
• Abbottlink
• Distance Alert
Configure General Settings

Demonstrate how to configure general settings.
Identify that after changing the Date/Time Zone or the System Language, the UI computer shuts down
and restarts.
On the General Settings screen, the operator can view the following information:
 Date and time zone.
 Number format
 System information
The operator can configure the speaker volume.
 Configure system date and time settings.
 Configure the number format.
 Adjust the speaker volume.
 Configure the system name and the system language.
 Configure the online help language
 Configure the Log On screen time-out setting.
 Enable or disable instrument processing when maintenance is overdue.
 Configure the system to require authentication for the general operator logon

Computer tab > General Settings screen > Configure general set-
tings
Audio Settings
• On the Audio Settings screen, the operator can view the following information:
 Audio alert global settings
 Message alert settings
• The supervisor can perform the following functions:
 Enable or disable global settings for audible alerts.
 Configure the alert volume.
 Configure a unique audible alert for critical messages.
 Configure a unique audible alert for alert messages.
 Configure a unique audible alert for notification messages.

Computer tab > Audio Settings screen
Host Set-Up
• On the Host Setup screen, the operator can view the following information:
 Interface options
 Transmission options
 Result release mode options
 Configure interface and query mode options.
 Configure transmission options for specimen, control, calibrator, sample status, and test
status.
 Configure result release mode options for specimen and control.

cial requirements>System configuration>Configure screen, Com-
puter tab>Host Setup screen
HL7 Communication
• On the HL7 Communication screen, the operator can view the following information:
 Message headers
 Sender channel options
 Receiver channel options
 Configure message headers.

 Configure sender channels.
 Configure receiver channels.
 Test HL7 communication settings.

puter tab>HL7 Communication screen
ASTM Communication
• On the ASTM Communication screen, the operator can view ASTM channel settings.
 Configure the IP address and the port number.

 Configure the character encoding setting.
 Test the ASTM channel settings.

puter tab>ASTM Communication screen
LAS Communication
FSE log-on is required to enable or disable LAS configuration.
• On the LAS Communication screen the operator can view the following information:
 Laboratory automation system (LAS) configuration options

 Sender channel settings
 Receiver channel settings

puter tab> LAS communication screen
Shortcuts
• On the Shortcuts screen, the operator can view the following information:
 Configured menu bar shortcut icons

 Available shortcut icon options
• The system administrator can configure two shortcuts as icons on the menu bar. Procedures and
Create order are the default options.

puter tab>Shortcuts screen
Configure an automatic backup

• Seven daily automatic backups and four weekly automatic backups are saved in the
designated destination (hard drive or USB).
• Automatic backups can be done either to the hard drive or a USB.
• The default for the automatic backup is off. If this is left as off, the customer will get a message
code daily that a backup was not performed.
• Backups can be completed in any status other than Processing or Pausing, if the system is in
either of these statuses when it is time for the automatic back to complete, they will get an error
message that the backup was not completed.

Setup > Configure computer settings > Automatic Backup > Con-
figure an automatic backup
Alinity PRO
• Alinity PRO is a data-sharing software application between Alinity systems and the Alinity PRO
computer. Alinity PRO provides the following options:
• Inventory sharing allows the laboratory to share reagents, calibrators, and controls between
different instruments that are controlled by a different user interface computer.
• The operational dashboard allows the operator to view a live representation of the current status
of all Alinity systems from one computer. With this information, the operator can schedule
activities that are needed on the instrument.
• On the Alinity PRO screen, the operator can view the Alinity PRO settings.
 The system administrator can perform the following functions:
 Enable or disable the inventory-sharing feature.
 Enable or disable status update message transmissions.
 Configure the IP address and the port number

puter tab>Alinity PRO screen
Abbottlink
• AbbottLink is a data-sharing software application between the laboratory instrumentation and
the Abbott internal systems for the transfer of instrument data, Abbott Mail documentation, and
system updates.
• On the AbbottLink screen, the operator can view the AbbottLink settings.
• If the logon for CSC or FSE is used, the following functions can be performed:
 Enable or disable the AbbottLink service.
 Enable or disable proxy settings.
 Configure proxy server settings.

puter tab>Abbottlink screen
Distance Alert
• On the Distance Alert screen, the operator can view the distance alert settings and can verify
the distance alert function.
 Enable or disable the distance alert.
 Enable or disable distance alert functionality for:
 Exceptions
 Quality control
 Calibration
 Reagent
 Supplies
 Procedures

puter tab>Distance Alert screen
Activity: Computer Configuration Activity (Application Specialist)
Purpose: To be proficient in configuration of the computer options of the systems

Actions: Complete the activity provided by the instructor
1. True or False. You can enable the distance alert to change color if an exception is generated.
2.Where can a customer disable the requirement for general operator log-on to require a PIN?
3.What is the maximum number of shortcuts that are customer editable?
4.True or False. If you have not configured the ASTM or HL7 settings, they will not be active options
on the host setup screen.
5. What are the three different audio alerts that can be configured?
6. What status must the system be in for an automatic backup to complete?

a. What happens if the instrument is not in that status?
7. Where can a customer disable the setting that disables sample processing when
maintenance is overdue?
Configure screen, Assay tab
Provide a brief description of the items that can be configured from the Assay tab.

Assay tab
There are nine screens that can be accessed from the Assay tab:
• Assay Parameters
• Calibrator Set
• Install/Uninstall Assays
• Import/Export Assays
• Assay Display Order
• Panel Definition
• Cal/QC Ordering
• Quality Control
• Westgard
Assay Parameters
• On the Assay Parameters screen, the operator can view the following information:
 General settings
 Calibration settings.
 Results settings
 Retest rules. For each test, the system can generate a maximum of four automatic rerun
orders. Retest rules are not applied to the following items:
 Calibrator tests
 Control tests
 Tests that are performed with a manual dilution
 Assays that have an assay status of Correlation
 Test that are performed from a specimen that is run on a laboratory automation system
 Demonstrate configuration of retest rules. Not ALL exceptions cause a retest rule to run. Use
operations manual reference below to review exceptions.
 SmartWash (c-series)
 Discuss purpose of Virtual line in regards to Smart Washes
 Both: The assay does not require separation from another assay and can use Line A or Line
B cuvettes
 Line A: The assay uses only the odd-numbered cuvettes.
 Line B: The assay uses only the even-numbered cuvettes.
 Edit general assay settings
 Edit calibration settings
 Edit result and interpretation information
 Configure SmartWash settings
 Create a user-defined assay.

cial requirements>System configuration>Configure screen, Assay
Tab>Assay Parameters screen

Tab>Assay Parameters Screen>Edit Results settings of assay
parameters

Tab>Assay Parameters Screen> Configure retest rules
Building a User-defined Assay
Review building a user-defined assay procedure in Operations Manual and building a calculated
assay.

Tab> Assay parameters screen
Online Operations Manual (Help): Assay Applications (c-series

photometric)> Assay parameters (c-series photometric, user
defined)
Calibrator Set
• On the Calibrator Set screen, the operator can perform the following functions:
 View calibrator data.
 View or print calibrator value sheets.
 Create new calibrator lots by scanning the bar codes on the calibrator cartons.
• The supervisor and the system administrator can perform the following functions:
 Manually create new calibrator lots or import calibrator data to create new calibrator lots.
 Edit calibrator data.
 Delete calibrator lots.

Tab>Calibrator Set screen
Create a new calibrator master lot from a bar code

• Demonstrate how to create a new calibrator lot for an existing calibrator set by scanning the
barcode on the calibrator carton.
Note: The product documentation for calibrators that have this capability states that calibrator lots
may be configured by using the bar code label on the calibrator carton.
• For c-series assays with this capability, values for the initial calibrator lot number must be
configured manually. Subsequent calibrator lots can be configured by scanning the bar code
on the calibrator carton.
• Calibrator sets must be configured for both IA assays and CC assays in the Calibrator Set screen.
• When the bar code on the calibrator carton is scanned, only the master lot number and the
expiration dated are updated. The calibrator values remain from the previously configured
master lot. To configure a new master lot for calibrators that have lot-specific calibrator values,
the user must verify the correct values are entered and must edit them if necessary.
• Calibrator data is retained on the system for a time period of 6 months past calibrator expiration
date. After the time period has elapsed, the system automatically deletes the calibrator data.

Setup > Configure assay settings > Calibrator Set > Create a new
calibrator lot from a bar code
Manually create a new calibrator lot

• Demonstrate how to manually create a new calibrator lot.
• Review that if the lot is not the initial calibrator lot, the existing calibrator data is copied to the
new lot.
• Review that the first configured lot number is designated automatically as the default lot
number, and that it can be changed.
• Review that the onboard storage capability is available for some calibrators. To identify
calibrators that have this capability and the onboard stability time for each calibrator, see the
product documentation.

Setup > Configure assay settings > Calibrator Set > Manually cre-
ate a new calibrator lot
Import calibrator data (c-series)
Demonstrate how to import calibrator data (c-series).

• The assay names and assay numbers for the data in the file and for the corresponding system
assays are displayed with an import status. Data for all calibrator levels is imported for assays that
have a status of OK. No data is imported for assays that have a status of No Assay or Previously
Defined. These statuses are displayed in red text.
• The first configured lot number is designated automatically as the default lot number.
The default lot number can be changed when the instrument status is Running or Processing if no
orders are pending for the calibrator set and the calibrator set is not loaded in the reagent carousel.
For all assays and all levels of the default lot number, the data must be defined.

Setup > Configure assay settings > Calibrator Set > Import calibra-
tor data (c-series)
Install/Uninstall Assays
• On the Install/Uninstall Assays screen, the operator can view or print assay installation reports.
 Install assays.
 Uninstall assays.
 Delete assays on the hard drive.

Tab>Install/Uninstall Assays screen
Install assay files

• Demonstrate how to install an assay file.

Setup > Configure assay settings > Install/Uninstall Assays > Install
assay files
• The assay file may be requested from Abbott Mail if the system is connected to AbbottLink. For
systems not connected to AbbottLink the assay file can be found on corelaboratory.abbott.com
and saved to a USB flash drive.
• Review that there is no longer a diagnostic procedure used to print a list of installed assays. There
are two ways to print the Assay Information report, either from the Assay parameters screen or
from the Installed assay screen.
Import/Export Assays screen (c-series)

• On the Import/Export Assays screen, the operator can export assay files for import on an Alinity
ci-series by using a c-series processing module.
• The system administrator can import assay files to an Alinity ci-series by using a c-series processing
module

Tab>Import/Export Assays Screen (c-series)
Assay Display Order

• On the Assay Display Order screen, the system administrator can configure the order in which
assays are displayed on screens and flyouts that have an assay list and in the following reports:
 Sample Laboratory Report
 Sample Status Report
 QC Summary Report

Tab>Assay Display Order screen
Panel Definition screen

• On the Panel Definition screen, the operator can view panel definitions for specimens, quality
control (QC), and calibrations.
 Configure new panels for specimens, QC, and calibrations. Up to twenty five unique panels
can be configured.
 Edit an existing panel.
 Delete a panel.

Tab>Panel Definition screen
Cal/QC Ordering
• On the Cal/QC Ordering screen, the operator can view calibration and quality control settings.
 Configure the ability to use calibrations that are beyond the calibration expiration.
 Configure the ability to use calibrators that are beyond the calibrator lot expiration.
 Configure the ability to use controls that are beyond the control lot expiration.
 Configure the ability to disable a reagent when a control fails.
 Configure the ability to require quality control to run after a calibration is generated.
 If a customer is using calibrators stored on-board in vial racks and having automatic
calibration orders generated, it is recommended that this setting be turned on.
 Configure whether the control expiration date must be entered before an order is created.

Tab>Cal/QC Ordering screen
Quality Control
• On the Quality Control screen, the operator can view quality control settings.
• The supervisor can perform the following functions:
 Configure multi-constituent and single-constituent controls.
 Edit multiconstituent and single-constituent controls.
 Import control data.
 Delete a quality control.

Tab>Quality Control screen
Review Manually create a new control lot
Review how to manually create a new control lot. This was covered in QC section.

Setup > Configure assay settings > Quality control > Manually cre-
ate a new quality control lot
Import quality control data

• Demonstrate how to import quality control data.
• Review the assay names and assay numbers for the data in the file and for the corresponding
system assays that are displayed with an import status. Data for all quality control levels is
imported for assays that have a status of OK. No data is imported for assays with the following
statuses:
 No Assay.
 Previously Defined.
 Units Mismatch.
 Version Mismatch.
These statuses are displayed in red text.
• Review that the first configured lot number is designated automatically as the default lot number
for control orders.
• Review that the assays that are disabled for a control level are not run when the control level is
ordered. All assays for each control level are enabled when a new control is imported. Disabled
and enabled assay statuses are retained when a new control lot number is created for the
control.

Setup > Configure assay settings > Quality control > Import quality
control data
Westgard
• On the Westgard screen, the operator can view the Westgard rule settings for each assay
installed on the system. The supervisor or system administrator can configure Westgard rule
settings for each assay installed on the system
Online Operations Manual (Help):Installation Procedures and spe-

Tab>Westgard screen
Activity: Assay Configuration Activity (Application Specialist)
Purpose: To be proficient in configuration of the Assay options of the systems

Actions: Complete the activity provided by the instructor.
1. True or False. All assays including i-series (with the exception of enzymes), require an active
calibrator set.
2.What is the difference between onboard stability and in-use stability?
3. Panels can be defined for which three order screens?
4. If the setting for an Automated control that is stored onboard is turned on, which field must
have a value entered into it?
5. Where can the setting for requiring quality control after calibration be turned on?
a. Under what circumstances would we recommend to a customer that this setting be

required to be turned on?
6. Where are the two locations that a list of installed assays (Assay information report) be printed?
7. True or False. Results units are changed via a drop down box and if changed, linearity and QC
values will be changed as well
Configure screen, Maintenance & Diagnostics tab
Provide a brief description of the items that can be configured from the Maintenance & Diagnostic
tab.

Maintenance & Diagnostics tab
There are two screens that can be accessed from the Maintenance & Diagnostics tab:
• Install/Uninstall Procedures.
• User-Defined Maintenance.
Install/Uninstall M&Ds
• Install new or revised maintenance and diagnostic procedure files.
• Uninstall maintenance and diagnostic procedures files.

cial requirements>System configuration>Configure screen, Main-
tenance & Diagnostics Tab>Install/Procedures screen
User-Defined Maintenance
• Create or edit a user-defined text-based maintenance procedure file.
 Import or export a user-defined maintenance procedure file.
 Print a list of the user-defined maintenance procedures with a description of each
procedure.
Online Operations Manual (Help):Installation Procedures and spe-

cial requirements>System configuration>Configure screen, Main-
tenance & Diagnostics Tab>User-Defined Maintenance screen
Create a user-defined maintenance procedure
Demonstrate how to create a user-defined maintenance procedure.

Setup > Configure maintenance and diagnostic settings >
User-Defined Maintenance > Create a user-defined maintenance
procedure
Application Specialist: It will be recommended for new installations that we create a c-series
maintenance procedure around changing the sample probe (semi-annually for instruments running
whole blood, yearly for all other instruments). Recommend creating procedure with instructions to
follow operators manual instructions for changing the sample probe.
Activity 1: Configure screen, General tab
Purpose: To become proficient at determining which parameters you may want to edit in your
laboratory.
Actions: Perform the activity at the instrument using the Operations manual (Help).
• Review the General tab configuration and make a list of the parameters you may want to edit in
your laboratory.

cial requirements > System configuration > Configure screen, Gen-
eral tab.
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Discuss any questions the participants may have after performing the activity.
Activity 2: Create a new user
Purpose: To become proficient at creating a new user.

Actions: Create a new user. Remember that once user is created, it will not be able to be
deleted, only inactivated.

Setup > Configure general settings > Users > Create a new user
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Activity 3: Configure screen, Computer tab
Purpose: To become proficient at configuring items on the computer tab.

Actions: Review the Computer tab configuration items and make a list of the items you may
want to edit in your laboratory.

Computer tab
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Activity 4: Configure an automatic backup
Purpose: To become proficient at creating an automatic backup.

Actions: Configure an automatic backup.

Setup > Configure computer settings> Automatic Backup > Con-
figure an automatic backup
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Activity 5: Configure screen, Assay tab
Purpose: To become proficient at configuring items on the assay tab.

Actions: List the screens that can be accessed from the Assay tab.

Assay tab
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion: Discuss any questions the participants may have after performing the activity.
Activity 6: Install assay files
Purpose: To become proficient at installing assay files.

Actions: Install an assay file.

Setup > Configure assay settings > Install/Uninstall Assays > Install
assay files
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 7: Manually create a new control lot
Purpose: To become proficient at creating new control lots.

Actions: Create a new control lot.

Setup > Configure assay settings > Quality Control > Manually cre-
ate a new quality control lot
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 8: Configure screen, Maintenance & Diagnostics tab
Purpose: To become proficient at configuring the maintenance & diagnostic tab information.
Actions: List the screens that can be accessed from the Maintenance & Diagnostics tab.

Maintenance & Diagnostics tab
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Knowledge Check: Configure the System

1. Select the following tasks the operator can perform on the Configure screen, General tab:
a) Create and edit users
b) Load racks and cartridges into trays
c) Change a personal user PIN
d) Install and verify system updates
e) Add, delete, or configure a module
f) Add a printer
g) Enable and disable barcode types
h) Configure reagent and supply low alerts
i) Configure automatic printing of reports
j) Enable and disable download options for Abbott Mail items
Answer:
2. True or False? Seven daily automatic backups and four weekly automatic backups are saved on
the hard drive and a USB flash drive.
Answer:
3. Which of the following is true of assay file installation?

a) The required instrument status is running.
b) You need to review the specific information for each assay before installation. Assays may
have specific installation requirements.
c) You do not need to refer to the assay-specific installation information for specific calibration
and quality control requirements.
d) Assay files that are installed from a USB flash drive are deleted and cannot be recovered.
Answer:
Review
Review the following questions to check your knowledge of setup.

1. Which statement is true when adding a printer?
a) The operator access level can be any operator.
b) You are not required to enter the IP address.
c) After the new printer is added, the printer must be verified before it is available to print a
report or document.
d) Once you start the process of adding a printer, you cannot cancel it.
Answer:
2. True or False? Before you install a system software update, you need to download the system
update software.
Answer:
3. Select all of the files that are collected in the Core Operational Data troubleshooting package:
a) Result data.
b) Assay activity data.
c) Reagent and Sample Manager log data.
d) Calibration data.
Answer:
4. Which one of the statements is true when creating a new calibrator lot from a barcode?
a) You cannot disable a c-series photometric assay.
b) You create a new calibrator lot for an existing calibrator set by scanning the bar code on the
calibrator carton.
c) The Configure command cannot be configured as an icon on the menu bar.
Answer:
5. Select all of the steps to retrieve a troubleshooting package that can be used for
troubleshooting by an Abbott Laboratories representative:
a) On the menu bar, tap System, and then tap Utilities.
b) On the Utilities screen, tap Troubleshooting.
c) Under Troubleshooting Packages on the Troubleshooting screen, tap a package to retrieve.
d) To send the troubleshooting package to AbbottLink, tap Retrieve AbbottLink.
Answer:
6. True or False? When an assay is installed that uses the data from a reference assay, the reference
assay must be installed first.
Answer:
7. True or False? You cannot request assay files from the Abbott Mail Inbox screen.
Answer:
8. True or False? The operator access level for manually requesting calibrator data files and assay
files is system administrator.
Answer:
Module 14: Utilities
\
Objectives: After completing this lesson, you should be able to perform tasks
from the:
• Backup/Restore screen
• System Updates screen
• Troubleshooting screen
Module Topics
Utilities provide tools that the Alinity ci-series system can use to help meet the needs of the
laboratory.
In this module, you will explore the:

• Utilities screen
Utilities
Utilities provide tools that the Alinity ci-series system can use to help meet the needs of the
laboratory. This lesson will provide you with basic knowledge about the utility procedures available
on the Alinity ci-series system.
After completing this lesson, you should be able to perform tasks from the:
• Backup/Restore screen.
• System Updates screen.
• Troubleshooting screen
• Current Firmware and Licenses screen
Utilities screen
Identify the four tasks that can be accessed from the Utilities screen.
The four tasks that can be accessed from the Utilities screen are:
• Backup/Restore
• System updates
• Troubleshooting
• Current Firmware
• Licenses

cial requirements > Utilities screen
Backup/Restore Screen
The three tasks that can be accessed from the Backup/Restore screen are:
• Perform a manual backup.
• Copy a backup to a USB flash drive.
• Restore a back-up.

cial requirements > Utilities screen > Backup/Restore screen
Perform a manual backup

• Demonstrate how to perform a manual backup. This can be done in any instrument status
except processing or pausing
• Review when a manual backup should be performed:
 After a software update is downloaded.
 A new assay file is downloaded.
 The system configuration is changed.

Troubleshooting > Back up and restore > Perform a manual
backup
System Updates screen
An Abbott Laboratories representative installs the Alinity ci-series and the system software. After the
system is running, occasionally software and hardware updates may be received that need to be
installed manually. System updates are distributed as technical service bulletins (TSBs) and can be
downloaded from the Abbott Mail screen. The system administrator can install simple TSBs. The
Abbott Laboratories representative needs to install more difficult TSBs.
Identify the tasks that can be accessed from the System Updates screen.
The tasks that can be accessed from the System Updates screen are:
• Decline non-mandatory system updates.
• Download software updates.
• Install and verify system updates.
Online Operations Manual (Help): Installation procedures and

special requirements > Utilities screen > System Updates screen
View or print system update documentation

• Demonstrate how to view or print system update documentation.
• Identify how to use the Rotate tool bar, Page tool bar, Zoom tool bar, Fit tool bar, and Find tool
bar.

Setup > System updates > View or print system update
documentation
Download the system update software
Demonstrate how to download the system update software

Setup > System updates > Download the system update software
Install a system update

• Demonstrate how to install a system update.
• Explain that the system administrator can install some technical service bulletins (TSBs). The
Abbott Laboratories representative will install other TSBs. All TSBs are tracked on the System
Updates screen.

Setup > System updates > Install a system update
Troubleshooting screen
Identify the procedure that can be done from the Troubleshooting screen.
The operator can perform the procedure Retrieve a troubleshooting package.

cial requirements > Utilities screen > Troubleshooting screen
Descriptions of troubleshooting packages
There are three troubleshooting packages available: Core Operational Data, the Instrument Log,
and the External Communication Log.
Core Operational Data
Includes core operational data (for example, result data, calibration data, and instrument
operational data) that is located in the operational data recorder (ODR) of the instrument.
The following files are collected:

 Result data
 Calibration data
 System log data
 Maintenance and diagnostic (MnD) data
 Assay activity data
 Reagent data
 Vortexer (ITV) data
 Liquid level detection (LLD) data
 Pipettor pressure monitoring (PM) data
 Wash buffer dilution assembly (IARM) data

 Wash monitoring (WAM) data
 Temperature data
 Vacuum pressure data
 Optics data
 Event data
 Motor data
Instrument Logs
• The following logs are collected:
 System Control Module logs (InstClient and InstServer)
 Processing module logs (c-series and i-series)
 Reagent and Sample Manager logs
 Communication logs with external systems (for example, HL7 and ASTM host communication
logs)
 Result data
 Assay activity data
 Liquid level detection (LLD) data
 Pipettor pressure monitoring (PM) data
External Communication Logs

• Includes all communication logs with external systems (for example, HL7 and ASTM host
communication logs).

cial requirements > Utilities screen > Troubleshooting screen >
Retrieve a troubleshooting package
Demonstrate how to retrieve a troubleshooting package. Review that troubleshooting packages

can be retrieved to Abbottlink or Retrieved to a Removable Media (USB).

Troubleshooting > Log retrieval > Retrieve a troubleshooting
package
Activity 1: Utilities screen
Actions: List the tasks that can be accessed from the Utilities screen.

cial requirements > Utilities screen
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 2: Backup/Restore screen
Actions: List the tasks that can be accessed from the Backup/Restore screen.

cial requirements > Utilities screen> Backup/Restore screen
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_________________________________________________________________
Activity 3: Perform a manual backup
Purpose: To become proficient at performing a manual backup

Actions: Perform a manual backup.

Troubleshooting > Back up and restore > Perform a manual
backup
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Activity 4: Troubleshooting screen
Actions: Identify the function that the operator can perform on this screen.

special requirements > Utilities screen > Troubleshooting screen
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 5: Descriptions of troubleshooting packages
Actions: List the types of troubleshooting packages that are available to the operator.

special requirements > Utilities screen > Troubleshooting screen >
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 6: Retrieve a troubleshooting package
Purpose: To become proficient at retrieving a troubleshooting package.

Actions: Retrieve a troubleshooting package.

Troubleshooting > Log retrieval > Retrieve a troubleshooting
package
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Discussion:
Knowledge Check: Utilities

1. Select the tasks the operator can perform on the Utilities screen:
a) Backup/Restore
b) Log on
c) System updates
d) Retrieve a Troubleshooting package
e) View the current firmware
Answer:
2. True or False? The Backup flyout allows you to enter a comment for a backup.
Answer:
3. Which of the following is true for the system software update installation?
a) You need to download the software installer for a system update (or a previous software
installed download that failed) before you can begin installation.
b) The operator access level for this procedure is not necessarily dependent on the system
update being performed.
c) The system update status must be Declined before software installation.
Answer:
4. True or False? On the Troubleshooting screen, you can retrieve system log packages that can be
used for troubleshooting by an Abbott Laboratories representative.
Answer:
Review

report or document.
Answer:
update software.
Answer:
a) Result data.
Answer:
calibrator carton.
Answer:
Answer:
Answer:
Answer:
Answer:
Module 15: Abbott Mail
\
Objectives: After completing this lesson, you should be able to:

• Describe and perform tasks from the Abbott Mail Inbox
screen
• Describe the function of AbbottLink
Module Topics
Familiarize yourself with the features of Alinity ci-series.

• Abbott Mail
• AbbottLink
Online Operations Manual (Help): Operating Instructions subsec-

tion Home screen
Abbott Mail
Objectives
After completing this lesson, you should be able describe and perform tasks from the Abbott Mail
Inbox screen.
Demonstration: Abbott mail
The facilitator will review and demonstrate Abbott Mail, including:

• Abbott Mail Inbox screen.
• Manual File Request screen.
• Manually request assay files.
• Manually request calibrator data files.
Abbott Mail Inbox screen

• Review the Abbott Mail Inbox screen.
 Assay file mail-allows assay files to be sent automatically or manually to the system software.
After an assay file is installed, the system software checks weekly for any updates to the assay
file. If an updated file is available, the updated file is sent automatically. The system
administrator needs to review the documentation before the updated file is installed.
 Assay Insert mail- When a new reagent lot is loaded on the system, the software requests a
new assay insert. The status of the insert remains as New until the system administrator reviews
and accepts the assay insert.
 System update- allows for system update notifications and system software updates to be
sent to the software. System updates are tracked as TSBs. The system can send
 Hardware notifications
 Software notifications
 Software notifications and installer
 Calibrator Data-displays the new and viewed calibrator data mail items.
The five functions the system administrator can perform are:

• Accept Abbott Mail items.
• Delete Abbott Mail items.
• Request assay files.
• Request calibration data files.
• Decline system updates.

screen > Abbott Mail Inbox screen
Manual File Request screen
Review the Manual File Request screen.

screen > Abbott Mail Inbox screen > Manual File Request screen
Manually request assay files

• Review the Manually request assay files procedure.

Setup > Abbott Mail > Manually request assay files
Manually request calibrator data files

• Demonstrate how to manually request calibrator data files.

Setup > Abbott Mail > Manually request calibrator data files
Activity 1: Abbott Mail Inbox screen
Actions: List the functions that can be accessed from the Abbott Mail Inbox screen.

screen > Abbott Mail Inbox screen
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 2: Manual Assay File Request screen
Actions: List the items that can be viewed from the Manual File Request screen.

screen > Abbott Mail Inbox screen > Manual File Request screen
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 3: Manually request assay files
Actions: List the items that can be viewed from the Manual File Request screen.

Setup > Abbott Mail > Manually request assay files
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Activity 4: Manually request calibrator data files
Actions: Perform the procedure Manually request calibrator data files. Identify the calibrator data file that
was requested.

Setup > Abbott Mail > Manually request calibrator data files
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
Review

report or document.
Answer:
update software.
Answer:
a) Result data.
Answer:
calibrator carton.
Answer:
Answer:
Answer:
Answer:
Answer:
Final Assessment
Final Assessment Activities
Objectives: • Assess Alinity ci-series Instrument Knowledge and

Operational Skills via Troubleshooting Activities and Final
Written Exam
Module Topics
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.
Final Assessment
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 to the system
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
Final Assessment
Complete the Final Written Assessment

• Demonstrate Competency in Performing Instrument Integration Scoring of 80% or Higher on the
Final Assessment.
Written Final Assessment (120 Minutes)

• LMS - Final Assessment – Participants should log in to the Knowledge Platform System (LMS) and
complete the Alinity ci-series Global Application Training Program Exit Exams and Course Surveys.
Appendix
Appendix
Appendix
Primary Components of the Alinity ci-series
Identify the hardware components of the Alinity ci-series

1. _____________________________
2. _____________________________
3. _____________________________
Appendix
SCM hardware components
Appendix
Label the following components:

1. ________________
2. ________________
3. ________________
4. ________________
5. ________________
6. ________________
7. ________________
8. ________________
9. ________________
10. ________________
11. ________________
12. ________________
Appendix
RSM Components
Label the following components:

1. _________________
2. _________________
3. _________________
4. _________________

Application Guide

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Global Alinity ci-series

Alinity ci-series Global Application Training | Internal Use Only|80002250 -101

Permission to use the Information is granted, provided that:

• the copyright notice appears on all copies;

• the Information is not modified in any way; and

• no graphics are used separate from accompanying text.

Copyright 2019, Abbott Laboratories, Abbott Park, Illinois.

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

Prerequisite activities that must be completed are:

 Service Tools Overview

Alinity ci-series Systems Safety Hazard Information

 Handling samples, reagents, calibrators, and controls.

How to Use This Guide

Activity: Name of Activity

• Demos will be conducted by the facilitator so all participants can see

Special Tables for Notes and References

Note: Will contain special information not contained within the

Reference: This table will contain references to published materi-

 Knowledge Management: Specific references to KM articles will

Procedure Map Reference: Bread crumbs leading to procedure

Online Operations Manual (Help): Specific references to the

Module 1: Instrument Overview .....................................................................1-1

Module 2: System Statuses .............................................................................2-1

Module 3: Basic Sample Processing ..............................................................3-1

Module 4: Consumables and Inventory Management................................4-1

Module 5: Reagent and Sample Manager (RSM) ........................................5-1

Module 6: Daily Maintenance ........................................................................6-1

Module 7: Calibrations ....................................................................................7-1

Module 8: Control Orders................................................................................8-1

Module 9: Patient Sample Orders ..................................................................9-1

Module 10: Additional Maintenance...........................................................10-1

Module 11: Common Errors and Troubleshooting ......................................11-1

Module 12: Basic Component Replacement .............................................12-1

Module 13: Configuration Options ................................................................13-1

Module 14: Utilities .........................................................................................14-1

Module 15: Abbott Mail .................................................................................15-1

Final Assessment Activities............................................................................16-1

Appendix ................................................................................................................ 17-1

Estimated Time: [40 minutes]

Objectives: • Review agenda and set class expectations

Setting Class Expectations

 Confirm completion of pre-training requirements by all participants; set completion

Using Service Tools

Purpose: To demonstrate the use of Knowledge Management searches to find troubleshooting

Application Specialist Activity: AbbottLink Activity

Purpose: To perform support related AbbottLink tasks.

Application Specialist Activity: Locating and Navigating MyGSS

Purpose: To become familiar with the location of the training checklist.

Application Specialist Activity: Locating Alinity Operations Manuals

Application Specialist Activity: Locating International Package Inserts via

Purpose: To become familiar with the link to international package inserts.

Application Specialist Activity: Adding notes to PDF files on an iPad

Application Specialist Activity: Service Documentation on MyGSS

Purpose: To become familiar with service documentation on the GSS Website.

Application Specialist Activity: Alinity c-series and i-series Photo Navigator

Application Specialist Activity: Net Promoter Score (NPS)

Purpose: To become familiar with the concept of NPS.

Purpose: To become familiar with the concept of ISS/IVP.

Module 1: Instrument Overview

Estimated Time: [285 minutes]

Objectives • Identify the primary components of the system to support

In this module, you will explore:

Online Operations Manual (Help):Refer to the Alinity