Customer Training Guide

Alinity ci-series
Global Customer Training
Alinity ci -series Global Customer Training | ADD-00066223 Intro-I

Proprietary statement
The Alinity ci-series software programs and system documentation are protected by copyright
(©2016, 2017 Abbott Laboratories, Abbott Park, Illinois). All rights are reserved.
The software and manual were developed solely for use with the Alinity ci-series as specified in the
operating instructions.
The information, documents, and related graphics published herein (the “Information”) are the sole
property of Abbott Laboratories. 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 trained personnel or
informational use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
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.
Portions of the Alinity ci-series software may include open source or third party software as further
explained in the Software License Attributions document, which can be accessed on the Utilities
screen.
Intro-II Alinity ci -series Global Customer Training | ADD-00066223

Disclaimers
All samples (printouts, graphics, displays, 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.
Any product information in training materials should be used in conjunction with the latest version
of the Operations Manual, Operations Manual addendum, or Product Information Letter. If
discrepancies in information exist within training materials or any other materials, the latest version
of the Operations Manual, Operations Manual addendum, or Product Information Letter takes
precedence.
The information was developed to be used by Abbott Laboratories trained personnel, by other
persons knowledgeable or experienced with the operation and service of the product identified, under
the direct supervision and with cooperation from Abbott Laboratories technical support or service
representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred in
connection with or arising from the use of the information by persons not fully trained by Abbott
Laboratories.
No confidential relationship shall be established in the event that any user of the Information should
make any oral, written or electronic response to Abbott Laboratories (such as feedback, questions,
comments, suggestions, ideas, etc.). Such response and any information submitted therewith shall
be considered non-confidential, and Abbott shall be free to reproduce, publish or otherwise use such
information for any purposes whatsoever including, without limitation, the research, development,
manufacture, service, use, or sale of products incorporating such information. The sender of any
information to Abbott is fully responsible for its content, including its truthfulness and accuracy and
its non-infringement of any other person’s proprietary rights.
Alinity ci -series Global Customer Training | ADD-00066223 Intro-III

Welcome to the Alinity Family
Congratulations on becoming an operator of the Alinity ci-series. The Alinity ci-series has a small,
compact, and scalable design to help you adapt to day-to-day and long-term needs withing your
laboratory. The system is supported by resourceful advocates consisting of dedicated professionals
who excel in engineering, medical technology, training, and service. As part of a dedicated customer-
training program, Abbott Laboratories will teach you how to operate, maintain, and troubleshoot the
system. We are dedicated to helping you achieve measurably better heath care with our resourceful
advocates, harmonized systems, and intelligent insights by providing you with the highest quality and
most reliable instrumentation.
The Alinity ci-series of analyzers has a scalable design to provide full integration of multiple clinical
chemistry and immunoassay systems, all of which are controlled by one user-friendly interface.
Overview
How to Use this Guide
To effectively support you, we have provided this training guide to build your expertise and confidence
in using the instrument.
This guide is designed to assist you throughout the training event. It should only be used in
conjunction with the Operations Manual (Help) to record key information and complete training
activities.
Always refer to the Operations Manual (Help) for the most accurate, up-to-date information regarding
the use and function of the instrument.
By design, this guide promotes your active participation throughout the course and reinforces the use
of the Operations Manual (Help).
To get the best training results, follow the direction of your instructor, contribute to discussions, ask
questions, share helpful experiences and insights, and engage fully in hand-on activities.
This guide was created for Alinity ci-series Software version 2.6 There may be some differences in the
available functions on the system depending on the software version. Refer to the Operations Manual
for additional detail.
Learning Formats
Depending on your location, training needs and equipment availability, you may be taking this course:
· In a classroom environment with a lab instrument and other learners

· On-site at your facility with your laboratory instrument, alone or with other learners
Intro-IV Alinity ci -series Global Customer Training | ADD-00066223

· Remotely via virtual training while on-site at a facility, alone or with other learners
This guide contains a variety of text, graphics, activities, and checkpoints. Content is presented in a
modular format to allow for maximum flexibility.
Safety
Personal Safety
Follow the safety requirements specific to the location of your training.
Depending on the location of your training, your facilitator may cover safety precautions specific to
the facility (such as emergency exits, location of automated external defibrillator (AED), etc.). You will
be informed regarding any additional safety requirements.
Your facilitator may also cover logistical items like breaks, nearest restrooms and on-site safety
equipment.
Take the appropriate safety precautions needed for your training environment, including (but not
limited to) personal protective equipment (PPE) such as gloves, lab coats and protective eyeware.
Instrument Safety
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).
Alinity ci -series Global Customer Training | ADD-00066223 Intro-V

ŽƵƌƐĞK ďũĞĐƟǀ ĞƐ
After completing this course you should be able to:
o Describe the major external and internal system components.
o Use the system software.
o Order and run specimens.
o Order and run assay calibrations and quality control samples.
o Complete maintenance activities.
o Troubleshoot common errors and issues.
o Remove and replace common components due to normal wear

during operation.
Intro-VI Alinity ci -series Global Customer Training | ADD-00066223

What You’ll Learn
Module Objectives
Basics · 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
System Statuses · 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 RSM
Consumables · Define a consumable
and Inventory · Identify the required consumables
Management
· 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 RSM
· Unload reagents from RSM
Reagent and Sample · Identify the primary components of the RSM
Manager (RSM) · Explain the meaning of RSM Status Indicators
· Identify Priority positions
Daily Maintenance · View Maintenance procedures
· Identify consumables used in Daily Maintenance
· Perform Daily Maintenance
Alinity ci -series Global Customer Training | ADD-00066223 Intro-VII

Module Objectives
Calibrations · 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
Control Orders · Describe control sample processing
· Create a control order
· Prepare and load control vials for onboard storage
· Initiate a control run
· Describe quality control result flags
· Archive QC (Quality Control) results
Patient Sample · Create a single specimen order and a bar-coded batch specimen order
Orders · Print the Order List Report
· View patient order and sample status details
· Identify the sample bar code requirements, requirements for
handling specimens and sample specifications and requirements
· Initiate or resume sample processing
· Load and unload samples from the reagent and sample manager
(RSM)
· Explain Sample interference indices principles (c-series)
· Review and release patient results and rerun exceptions
· Explain result flags
· Add a comment to a patient result
· Add dilution/replicates to an order
· Archive patient results
Basic Sample · Describe the basics of the Photometric method (c-series)
Progression · 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
Intro-VIII Alinity ci -series Global Customer Training | ADD-00066223

Module Objectives
QC Analysis · Explain quality control analysis including Westgard Rule application
· Describe the Levey-Jennings (Graph) screen
· Perform Levey-Jennings procedures
· Describe the Quality Control Summary screen
Additional · Perform weekly, monthly, triannual, quarterly, semiyearly and as-
Maintenance 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
Common Errors and · Describe the troubleshooting process
Troubleshooting · 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
· Perform an emergency shutdown
· Perform a Diagnostic Procedure
· Use diagnostic procedures to resolve system issues
Basic Component · View procedures for component replacement
Replacement · Replace components as needed (c-series and i-series)
Configuration · Perform configuration tasks from the:
Options 4 Configure screen, General tab
4 Configure screen, Computer tab
4 Configure screen, Assay tab
4 Configure screen, Maintenance and Diagnostics tab
Utilities · Perform tasks from the:
4 Backup/Restore screen
4 System Updates screen
4 Troubleshooting screen
Abbott Tools and · Describe and perform tasks from the Abbott Mail Inbox screen
Resources · Describe the function of AbbottLink
Appendix A: Lab · Activity 1: Update Supplies and Daily Maintenance
Activities · Activity 2: Run Calibrations and QC
· Activity 3: Patient Run and Troubleshooting
Alinity ci -series Global Customer Training | ADD-00066223 Intro-IX

Module Objectives
Appendix B: Patient · Introduction
Run Activities · Activity 1
· Activity 2
· Activity 3
Appendix C: · Job Aid
Additional Resources
On the Job Training · Introduction
Guide · Definition
· Training Tips and Techniques
· Training Checklist
· Using On-line Operations Manual
· Training Checkout Activity
Intro-X Alinity ci -series Global Customer Training | ADD-00066223

Instrument Basics
1 Instrument Basics
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Ϯ, ŽƵƌƐ
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
Alinity ci -series Global Customer Training | ADD-00066223 1-1

Instrument Basics
K ďũĞĐƟǀ ĞƐ
After completing this module, you should be able to perform:
o Identify the primary components of the system to support

application tasks
o Identify the primary components of the system
o Describe the features of the system control module (SCM)
o Identify major external and internal system hardware components

of the Alinity c and Alinity i processing modules
o Identify the main elements of the User Interface screen, Home

screen and Menu bar
o Log on to the System
o Lock the User Interface
o Access and navigate the online Operations Manual and Procedure

Map
¥ 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 System documentation
1-2 Alinity ci -series Global Customer Training | ADD-00066223

Instrument Basics
/ŶƚƌŽĚƵĐƟŽŶ
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.
¥ Note: A multimodule system includes multiple processing modules

in different combinations of chemistry and immunoassay processing
modules.

Instrument Basics
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.

Instrument Basics
· 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.
¥ Refer to Alinity ci-series Operations Manual for more information
Section 1: Use or function > Alinity ci-series hardware overview >

Primary components of an Alinity ci-series
System Control Module (SCM)

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
Use or function > Alinity ci-series hardware overview > Primary

components of an Alinity ci-series > System Control Module (SCM)
• The System Control Module (SCM, front view) exterior is composed of the:
4 Adjustable monitor: Displays the user interface of the Alinity ci-series and accepts on-screen
selections from the operator.
4 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.
4 SCM shelf: Provides a small shelf for the operator and provides access to remove the barcode
scanner.
4 Bar code scanner: Provides a means to scan sample bar codes and supply bar codes.
4 SCM front door: Provides access to the user interface computer and the procedure lock..
· The System Control Module (SCM, rear view) exterior is composed of the:
4 Rear SCM cover: Provides access to the user interface computer power strip.
4 Rear SCM upper access panel: Provides access to the Ethernet switch.
4 Network connectors: Provides connections for external devices, such as the host interface and
Abbottlink
4 SCM main power breaker: Powers on and powers off the SCM power supply
4 Rear SCM lower access panel: Provides access to the power supply and RSM electronics.

Instrument Basics
System Control Module (SCM)

hardware components
Hardware components of the system control module (SCM) include the user interface hardware and
the reagent and sample manager (RSM) hardware.
· Use the reference below to pull up the graphic in the operations manual to review each hardware
component of the SCM. Reinforce that the SCM supplies power to the SCM and RSM

are:
Section 1 Use or function>Alinity ci-series hardware overview>Primary

components of an Alinity ci-series>System Control Module (SCM)>System
Control Module (SCM) hardware components.

Instrument Basics
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 Provides a temporary, continuous flow of power to the
power supply (UPS) user interface (UI) computer during a power failure,
which helps the operator to save data as necessary
(Optional and to perform a controlled shutdown procedure
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 connectors Provides connections for external devices, such as
host interface 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
Use or function > Alinity ci-series hardware overview > Primary

components of an Alinity ci-series > System Control Module (SCM) >
System Control Module (SCM) hardware components

Instrument Basics
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.
ĚũƵƐƚƚŚĞŵŽŶŝƚŽƌƉŽƐŝƟŽŶ
Adjust the height and angle of the monitor using pivot points on the monitor support arm.
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.
¥ Refer to Procedure Map: Setup > Adjust the monitor position >Adjust the
monitor position.

Instrument Basics
Distance Alert
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:
· If the distance alert is configured for notifications, 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:
· If the distance alert is configured for notifications, an amber

badge is displayed on any icon on the menu bar except the
Results icon
· An amber badge is displayed on the Results icon if the distance
alert is configured for exception notifications
· 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.

Instrument Basics
Color Meaning(s)
Distance alert off The distance alert is not illuminated when one of the following
conditions is present:
· The distance alert is disabled.

· The user interface computer is shut down
· The instrument status of one of more processing modules in
the workstation is not Running, Processing, or Pausing.
Reagent and Sample Manager (RSM)

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.

Instrument Basics
One primary RSM transports samples and reagents through an Alinity ci-series regardless of the type
and number of processing modules.
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.

Instrument Basics
ĐƟǀ ŝƚǇϭ
Adjust Monitor
Perform the steps to adjust the monitor for proper viewing.
ĐƟǀ ŝƚǇϮ
Locate Components
Locate the following components:
· UI Computer
· Bar code Scanner
· Network Connectors
Review
1. True or False? When adjusting the monitor, you should locate the monitor at a comfortable eye
level.
2. Which module supplies power to the RSM?
a. Processing Module
b. System Control Module (SCM)

Instrument Basics
Processing Module
Unless otherwise indicated, processing module is used generically throughout this manual to refer to
both types of modules.
Alinity c Processing Module
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 Processing Module
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.

Instrument Basics
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.
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 sensors.

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 assay-
¥ 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.
¥ Refer to Online Operations Manual (Help) for more information.
Section 1 Use or function > Alinity ci-series hardware overview > Primary
components of an Alinity ci-series > Processing module > Processing
Module (Alinity c)

Instrument Basics
Processing Center - Alinity c-series

· The processing center is the main activity area of the processing module.
· Samples and reagents are dispensed and mixed in the reaction carousel where assay processing is
performed.
The Alinity c-series processing center is composed of the following:
· Pipetting hardware
· Reaction carousel hardware

Instrument Basics
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.

Instrument Basics
WŝƉĞƫŶŐ, ĂƌĚǁ ĂƌĞ
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.

Instrument Basics
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).

Instrument Basics
^ĂŵƉůĞt ĂƐŚ^ŽůƵƟŽŶƌĞĂ
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.
¥ Refer to Online Operations Manual for more information.
Section 1: Use or function > Alinity ci-series hardware overview >

Processing modules > Processing module (Alinity c)> Processing center
(Alinity c)> Pipetting hardware (Alinity c)

Instrument Basics
ZĞĂĐƟŽŶĐĂƌŽƵƐĞůŚĂƌĚǁ ĂƌĞ
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

Instrument Basics
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.
-Use or function > Alinity ci-series hardware overview > Processing

modules > Processing module (Alinity c)> Processing center (Alinity c)>
Reaction carousel hardware (Alinity c)

Instrument Basics
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.

Instrument Basics
· 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.
2) ICT Reference Solution pump: Uses the syringe on the left side of the pump to deliver
ICT Reference Solution into the ICT Reference Solution cup. After the ICT Reference Solution is
measured, 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
operates.
-Use or function > Alinity ci-series hardware overview > Primary

components of an Alinity ci-series > Processing modules > Processing
module (Alinity c) > Supply and pump center (Alinity c)

Instrument Basics
Reagent supply center - Alinity c-series

· The reagent supply center provides cooled storage at a controlled temperature for a maximum of 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:
4 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.
4 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. When the reagent positioner
is in the closed position, the cartridge or rack can be transferred to the reagent carousel.
4 Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto
the reagent positioner
¥ Refer to Alinity ci-series Operations Manual for more information.
- Use or function > Alinity ci-series hardware overview > Primary

module (Alinity c) > Reagent supply center (Alinity c)
ĐƟǀ ŝƚǇϯ
D ĂƚĐŚƚŚĞŝƚĞŵǁ ŝƚŚƚŚĞĚĞĮŶŝƟŽŶ͘
Component Definition
____Front processing center cover 1. Provides access to bulk solution storage and
pump center.
____ Bulk solution door 2. Provides access to the module electronics
____ Front electronics door 3. Provides access to the components that
perform assay processing activities.

Instrument Basics
ĐƟǀ ŝƚǇϰ
/ĚĞŶƟĨǇ ůŝŶŝƚǇĐͲƐĞƌŝĞƐƉƌŽĐĞƐƐŝŶŐŵŽĚƵůĞ;ƌĞĂƌǀ ŝĞǁ ͿĞǆƚĞƌŝŽƌ
Component Definition
___Rear processing center cover 1. Provides access to the water management
unit.
___Rear access panel 2. Provides additional access to processing
center components.
___Rear lower access panel 3. Provides access to the components that
perform assay processing activities.
___Power supply panel 4. Powers on and powers off the power supp
___ Processing module main power 5. Provides access to the processing module
breaker power supply.

Instrument Basics
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 has 47 positions in the 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:
4 Front processing center cover: Provides access to the components that perform assay-
¥ Note: The front processing center cover is monitored by two sensors.

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.
4 RV hopper cover: Provides access to the RV hopper to replenish reaction vessels.

4 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:
4 Rear processing center cover: Provides access to the components that perform assay-
processing activities
¥ 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..
4 Rear access panel: Provides additional access to processing center components.

4 Rear electronics panel: Provides access to instrument electronics.
4 Processing module main power breaker: Powers on and powers off the power supply.
4 Rear fluidics panel: Provides access to pumps and syringes

Instrument Basics

components of an Alinity ci-series > 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 where assay
processing is performed.
The Alinity i-series processing center is composed of the:
· Processing Path
· Pretreatment Path
· Pipetting Hardware
· RV Loader

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.

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

Instrument Basics
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.
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.
4 The load diverter (LD) directs RVs from the load lane to the incubation lane.
4 The STAT diverter (STD) directs RVs from the incubation lane to the reaction lane for STAT
assay processing.
4 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 reaction vessels before the RV unloader discards
them into the solid waste container.

Instrument Basics
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.

module (Alinity i) > Processing center (Alinity i) > Process path (Alinity i)

Instrument Basics
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.

Instrument Basics
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 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
· Pretreatment unload diverter (pUD): Unloads RVs used for sample pretreatments and sample
dilutions from the pretreatment path into the solid waste container

components of an Alinity ci-series> Processing modules >Processing
module (Alinity i) >Processing center (Alinity i) >Pretreatment path
(Alinity i)

Instrument Basics
WŝƉĞƫŶŐŚĂƌĚǁ ĂƌĞ
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.
WŝƉĞƩŽƌƐ
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.
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.

module (Alinity i) > Processing Center (Alinity i) > Pipetting hardware
(Alinity i)

Instrument Basics
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.
-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)

Instrument Basics
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
-Use or function >Alinity ci-series hardware overview > primary

components of an Alinity ci-series >Processing modules > Processing
module (Alinity i) > Supply center (Alinity i)

Instrument Basics
ƵůŬƐŽůƵƟŽŶƐƚŽƌĂŐĞĂƌĞĂ
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.

Instrument Basics
ƵůŬƐŽůƵƟŽŶƌĞƐĞƌǀ ŽŝƌĂƌĞĂ
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.

Instrument Basics
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.
· RV waste storage tray: Holds the RV waste container.

module (Alinity i) > Supply center (Alinity i)

Instrument Basics
Reagent supply center - Alinity i-series

· The reagent supply center provides cooled storage at a controlled temperature for reagent
cartridges, maintenance solutions, 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 of the Alinity i-series is composed of the:
4 Reagent carousel
4 Reagent positioner
4 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. The reagent carousel holds a maximum of 47 bar-coded reagent cartridges, maintenance
solutions, and vial racks in a cooled environment at a controlled temperature.
• 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 transfered to the reagent carousel.
· Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.

module (Alinity i) > Reagent supply center (Alinity i)

Instrument Basics
K ƉƟŽŶĂůŽŵƉŽŶĞŶƚƐ
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
-Use or function >Alinity ci-series hardware overview > Primary

components of the Alinity ci-series > Processing modules > optional
component
ĐƟǀ ŝƚǇϱ
/ĚĞŶƟĨǇ ůŝŶŝƚǇŝͲƐĞƌŝĞƐƉƌŽĐĞƐƐŝŶŐŵŽĚƵůĞ;ĨƌŽŶƚǀ ŝĞǁ ͿĞǆƚĞƌŝŽƌ
components
Components Definition
___ Front processing center cover 1. Provides access to the RV hopper to
replenish reaction vessels (RVs).
___ RV hopper cover 2. Provides access to the bulk solution storage
area and the RV waste storage area
___ Bulk solution door 3. Provides access to components that
perform assay-processing activities.

Instrument Basics
ĐƟǀ ŝƚǇϲ
/ĚĞŶƟĨǇ ůŝŶŝƚǇŝͲƐĞƌŝĞƐƉƌŽĐĞƐƐŝŶŐŵŽĚƵůĞ;ƌĞĂƌǀ ŝĞǁ ͿĞǆƚĞƌŝŽƌ
components
Components Definition
___ Rear processing center cover 1. Provides access to instrument electronics.
___ Rear access panel 2. Provides additional access to processing
center components.
___ Rear electronics panel 3. Powers on and powers off the power
supply.
___ Processing module main power 4. Provides access to the components that
breaker perform assay-processing activities.
___ Rear fluidics panel 5. Provides access to pumps and syringes.

Instrument Basics
^ǇƐƚĞŵ^ŽŌǁ ĂƌĞ

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.

Instrument Basics
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.
Supervisor Used to perform supervisor functions such as the following
examples:
· Configure system settings.

· Approve maintenance logs.
· Install and uninstall assays.
· Accept Abbott Mail Items.
The Log on area 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.

Instrument Basics
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:
4 Tap the Plus button.

4 Type the operator ID.
4 Tap the + Done button.
3. To display the Home screen, tap the four-digit PIN for the operator ID.
The User Interface can be locked when not in use by using the lock button icon located in the screen
header. The system will also automatically lock after 10 minutes of inactivity (default).
When the User Interface is locked, the operator is not logged off. Any samples that are in process will
generate results with the last logged on operator ID until a new operator performs a log on.
-Operating instructions > Log On screen> Log On screen element

descriptions

Instrument Basics
User Interface (UI)

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. 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.
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.

Instrument Basics
Menu bar
The menu bar provides navigation elements that are used to display screens, flyouts, and menus.
· Alert Center. Provides the Alert Center button, which displays a flyout of status information, and
provides two types of status indicators for system problems that require attention. Alerts and
notifications will be covered in a later section.
· Icons (including the System button) and navigation elements that provide access to a specific screen
and functions. The menu bar provides these icons:
4 Home
4 Sample Status
4 Orders
4 Results
4 QC
4 CAL
4 Reagents
4 Supplies
4 System button. Displays a menu of commands. System menu commands that are configured as
icons are not displayed on the menu.
§ Cal/QC inventory
§ Procedures Log
§ Abbott Mail
§ Configure
§ System Logs
§ Utilities
§ Operations Manual (Help)
4 Configurable icons
§ Navigation elements that can be configured to provide navigation for common functions.
Some of the System menu commands can be configured for these icons.
-Use or function > Alinity system software overview > Menu bar

Instrument Basics
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:
4 Host
4 Printer
4 Alinity PRO
4 LAS
4 Abbottlink
4 Abbott Mail
-Operating Instructions > Home screen element descriptions-scroll to

system status bar or there is an error condition

Instrument Basics
/ŶĨŽƌŵĂƟŽŶĂƌĞĂ
· RSM Image displays the RSM, the RSM name (if configured), and the current status for the RSM.
· Processing module Image Displays the module type, the module name (if configured), 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:
4 Instrument status
4 Reagent status
4 Supply status
4 QC status
4 Calibration status
4 Maintenance
4 Tests in Progress
4 Total Samples
4 Sample Status button
4 Exceptions
4 Exceptions button
4 Orders Pending
4 Orders button
-Operating instructions > Home screen > Home screen element

descriptions-scroll down to Information area
&ƵŶĐƟŽŶďƵƩŽŶƐ
· Shutdown
· Start
· Stop
· Pause
· Run
· Text Size

Instrument Basics
ĐƟǀ ŝƚǇϳ

WƌĂĐƟĐĞůŽŐŐŝŶŐŽŶ
Discussions: Discuss any questions or issues that may arise from the activity.
ĐƟǀ ŝƚǇϴ
WƌĂĐƟĐĞůŽĐŬŝŶŐƚŚĞh ƐĞƌ/ŶƚĞƌĨĂĐĞ;h /Ϳ

Instrument Basics
K ŶůŝŶĞ ŽĐƵŵĞŶƚĂƟŽŶ͗ ĞĮŶŝƟŽŶ

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
h ƐŝŶŐŽŶůŝŶĞĚŽĐƵŵĞŶƚĂƟŽŶ
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.
ĐĐĞƐƐƚŚĞK ŶůŝŶĞK ƉĞƌĂƟŽŶƐŵĂŶƵĂů

· Review the procedure and identify the two ways to access the Operations Manual (Help).
· Describe that the Operations Manual (Help) opens to the main cover page when accessed from the
menu bar. When accessed using the help button, it displays information on the screen that was in
use when selecting Help.
· The monitor is a touch screen.
-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.

Instrument Basics
dŚĞŽƌŐĂŶŝǌĂƟŽŶŽĨƚŚĞůŝŶŝƚǇĐŝͲƐĞƌŝĞƐK ƉĞƌĂƟŽŶƐD ĂŶƵĂů;, ĞůƉ

Ϳ
· The operations manual contains the following areas:
4 Title bar: Displays the title of the topic
4 Toolbar: Provides elements for navigation
4 Navigation pane: Provides an area to browse the operations manual content
4 Topic Pane: Displays the topic content
4 Close button: Closes the operations manual
How to locate and use the Procedure Map

· The Procedure Map is grouped into task-related categories.
· Procedure Map button located on the tool bar and the Procedure Map tasks lists.
· Procedure Map is a quick reference guide that quickly takes users to every procedure required to
perform their job.
-System documentation > Procedure 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

Instrument Basics
ĐƟǀ ŝƚǇϵ
h ƐŝŶŐƚŚĞŽŶůŝŶĞŽƉĞƌĂƟŽŶƐŵĂŶƵĂů
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.
ĐƟǀ ŝƚǇϭϬ
Using the Procedure Map
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.
ĐƟǀ ŝƚǇϭϭ
Access Screen Help
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.

Instrument Basics
Review
1. Identify the primary components of the Alinity ci-series: (Select all that apply)
b. Reaction Carousel
c. Supply and Pump Center
d. System Control Module
e. Reagent and Sample Manager
2. Which module supplies power to the reagent and sample manager (RSM)?
b. System Control Module
c. Alinity c Module
3. The reagent supply center cooled, temperature-controlled storage for reagent cartridges,
maintenance solutions, and frequently used calibrators and controls.
a. True
b. False

Instrument Basics
4. Select all methodologies used by the Alinity c. (Select all that apply)
a. Photometric
b. Chemiluminescent microparticle immunoassay (CMIA)
c. Potentiometric
d. ChemiFlex
5. Identify the item, or component, that matches this description- Provides access to the components
that perform assay-processing activities.
a. Rear fluidics panel
b. Rear processing center cover
c. Rear access panel
d. Rear electronics panel
6. Select the location of the alert center on the User Interface.
a. Within the screen header
b. At the top of the menu bar
c. Bottom of screen near the function button
d. Access using the System button

Instrument Basics
7. When you lock the user interface, the operator is automatically logged off.
a. True
b. False
8. Select all the components listed that are part of the Alinity c processing center. (Select all that
apply)
a. Vortexer
b. Cuvette Washer
c. ICT Unit
d. Diverters
e. Liquid Waste Arm
f. Mixers

Instrument Basics
9. Select the methodologies used by the Alinity i. (Select all that apply)
a. CMIA
b. Photometric
c. Potentiometric
d. ISE
10. Select all that components listed that are part of the Alinity i processing center. (Select all that
apply)
a. Vortexer
b. Cuvetter Washer
c. Pre-Trigger and Trigger Manifold
d. Diverters
e. RV Waste Storage Area
f. Liquid Waste Arm
g. Reaction Carousel

2 System Statuses
ϭ͘ ϱŚŽƵƌƐ
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
2-1 Alinity ci-series Global Customer Training | ADD-00066223

System Statuses
K ďũĞĐƟǀ ĞƐ
After completing this module, you should be able to:
o Identify the various statuses of the processing module and reagent

and sample manager (RSM)
o Change the status of the processing module and RSM
o Explain when you would need to cycle power
o Cycle power to the system
o Cycle power to the processing module and the reagent and sample
manager (RSM)

The section 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
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.
Alinity ci-series Global Customer Training | ADD-00066223 2-3

System Statuses
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:

System Statuses
Status Description
c-series
· Initialization after Start is selected:

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

4 Homes the motors
4 Confirms that processing center covers are closed
4 Confirms that the RV unloader is in the correct position
4 Performs a vacuum check
4 Verifies that the reagent carousel inventory is adequate
reagent positioner
· Initialization after Run is selected:
4 Washes the pipettor probes
4 Starts the mixing of the microparticles
4 Verifies that the supply inventory is adequate
4 Performs a background check
4 Fills the process path load lane with clean reaction vessels
(RVs)
4 Clears RVs from the pretreatment path and adds clean RVs

System Statuses
Status Description
RSM
4 Homes all moving parts
4 Confirms that front processing center covers are closed for
each processing module
4 Confirms that the bar code reader is functioning correctly
4 Homes the sample positioner for each processing module
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.

System Statuses
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.

System Statuses
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.

System Statuses

System Statuses
/ŶŝƟĂƚĞŽƌZĞƐƵŵĞ^ĂŵƉůĞWƌŽĐĞƐƐŝŶŐ
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.

System Statuses
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.

System Statuses
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)

System Statuses
WŽǁ Ğƌ^ǁ ŝƚĐŚĂŶĚD ĂŝŶWŽǁ ĞƌƌĞĂŬĞƌ>ŽĐĂƟŽŶƐ
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.

System Statuses
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.

System Statuses
ĐƟǀ ŝƚǇϭ
Cycle Power to the System
1. Locate the Cycle Power to the System procedure in the Operations Manual. (Print)
2. Perform Cycle Power to the System procedure.
ĐƟǀ ŝƚǇϮ
Start the processing module and the reagent and sample manager
(RSM)
Start the processing module and the reagent and sample manager (RSM).
1. Watch and listen as the instruments go through their initialization processes

System Statuses
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

System Statuses
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

Consumables and Inventory
3 Management
ϭ͘ ϱŚŽƵƌƐ
Module Topics
Familiarizing yourself with the required consumables, reagents, and accessories is essential to
ensuring the instrument functions and performs appropriately.
· Consumables
· Reagents
· Accessories and supplies

Consumables and Inventory Management
K ďũĞĐƟǀ ĞƐ
o Define a consumable
o Identify the required consumables
o Replace and update the consumable inventory
o Identify and prepare the reagents used in the Alinity ci-series
o View or print assay inserts
o Prepare onboard solutions and sample diluents
o Identify the required accessory for reagents of the Alinity ci-series
o Load/Unload trays and cartridges into the reagent sample manager

(RSM)
o Unload reagents from the reagent and sample manager (RSM)

are:
Section 1 Use or Function subsections; Required consumables and

Required accessories
Section 5 Operating Instructions subsections; Consumable inventory

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

Requirements for handling the consumables

Inventory Management
Part of your daily routine involves checking and updating needed supplies for the instrument.
Keeping up with inventory management ensures efficiency and continuous testing. You need to check
your consumables and accessories, and update them in the system on a regular basis.
There needs to be an adequate supply of sample cups or tubes, and you need to have enough racks for
samples. You will also use purchased calibrator and control bottles for testing.
Before performing sample processing, verify that your onboard consumable inventory is adequate.
The required consumables of the ci-series are listed in the boxes below:
Alinity c Processing Module Alinity i Processing Module

Bulk Solutions: Bulk Solutions:
· Alkaline Wash (0.5 L bottle) · Pre-Trigger solution (1 L bottle)

· ICT Reference Solution (1L bottle) · Trigger solution (1 L bottle)
· Acid Wash (0.5 L bottle) · Concentrated Wash Buffer (2 L bottle)
Sample onboard wash solutions: Probe Conditioning Solution
· Acid probe wash Reaction Vessels (500 RV’s per bag)

· Detergent A
ICT module (optional) Sample cups
Onboard and Maintenance Solutions
Sample cups
¥ Note: Review warnings or instructions provided on product-specific

labels, in the product documentation, and in product-specific Safety Data
Sheets prior to handling or loading reagents, solutions, controls, and
calibrators.

Consumables c-series
Bulk Solutions
The Alinity c-series uses three bulk solutions.
Bulk solutions are liquid solutions that are provided in large quantities for use during sample
processing.
Each bulk solution bottle is loaded on the bulk solution door.
Each bottle is labeled with the expiration date. Inventory tracking and consumable replacement is
performed from the Supplies Screen.
¥ For specific information about each bulk solution and onboard solution,
see the product documentation.

ůŬĂůŝŶĞt ĂƐŚ;Ϭ͘ ϱ>ďŽƩůĞͿ

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.
CAUTION: Follow all safety precautions as described on product-

specific labels, in the product documentation, and
in product-specific Safety Data Sheets.
ĐŝĚt ĂƐŚ;Ϭ͘ ϱ>ďŽƩůĞͿ

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.
CAUTION: Follow all safety precautions as described on product-

specific labels, in the product documentation, and
in product-specific Safety Data Sheets.

/dZĞĨĞƌĞŶĐĞ^ŽůƵƟŽŶ;ϵϳ ϱŵ>ŝŶĂϭ>ďŽƩůĞͿ
A midconcentration 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.
K ŶďŽĂƌĚ^ŽůƵƟŽŶƐ
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.

^ĂŵƉůĞK ŶďŽĂƌĚt ĂƐŚ^ŽůƵƟŽŶƐ

Sample onboard wash solutions, Acid Probe Wash and Detergent A, are replaced every 24 hours. Use
a measuring device to transfer solution from either cartridge bottle into a 16 mm x 100 mm sample
tube.
The sample tube is loaded into the sample wash solution holder. It is the operator’s responsibility to
place the tubes in the correct location.
Inventory tracking and consumable replacement is performed from the Supplies Screen.
¥ For the Onboard Solution Replacement Procedure refer to the Alinity

ci-series Operations Manual Section 5 Operation Instructions subsection;
Consumable inventory management.
¥ To locate the procedure using the online Procedure Map refer to the
following location:
-Sample processing>Prepare for operation>Replenish the inventory and

empty the waste> Consumable inventory management> Replace sample
onboard wash solutions and update the inventory (c-series).

ICT Module
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.
Inventory tracking and consumable replacement is performed from the Supplies Screen. The warranty
for the ICT module is 20,000 samples or 3 months after installation, whichever occurs first.

D ĂŝŶƚĞŶĂŶĐĞ^ŽůƵƟŽŶƐ
The c-series maintenance solutions are liquid solutions that are supplied as a three-component kit
and are used during the automated daily maintenance procedure.
The maintenance solutions are stored at a temperature of 15°C to 30°C and are stable on the system
for 14 days or 12 tests, whichever occurs first.
Use of maintenance solutions will be reviewed in the Daily Maintenance training module.
¥ Note: Discard used sample tubes, bottles, and/or cartridges according to

the laboratory waste disposal procedures of the facility.

Consumables i-series
ƵůŬ^ŽůƵƟŽŶƐ
The Alinity i-series uses three bulk solutions. Each bulk solution bottle is loaded on the bulk solution
door.
Each bottle is labeled with the expiration date. Inventory tracking and consumable replacement is
performed from the Supplies Screen.
WƌĞͲdƌŝŐŐĞƌ^ŽůƵƟŽŶ;ϭ>ďŽƩůĞͿ
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.

dƌŝŐŐĞƌ^ŽůƵƟŽŶ;ϭ>ďŽƩůĞͿ
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.
ŽŶĐĞŶƚƌĂƚĞĚt ĂƐŚƵīĞƌ;Ϯ>ďŽƩůĞͿ
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.

WƌŽďĞŽŶĚŝƟŽŶŝŶŐ^ŽůƵƟŽŶ
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.

ZĞĂĐƟŽŶs ĞƐƐĞůƐ
Reaction vessels (RVs) are disposable containers in which the CMIA reaction occurs.
The operator can add RVs at any time. Do not overfill the RV hopper.
Inventory tracking and consumable replacement is performed from the Supplies Screen.

ci-series Operations Manual Section 5 Operating Instructions subsection;
following location:

empty the waste>Consumable inventory management>Replenish reaction
vessel (RVs) and update the inventory (i-series)
¥ Refer to Operations manual (Help) reference: Performance characteristics

and specifications>Specifications and requirements>System
capacities>Processing module capacities (i-series) for additional
information
Discard used sample tubes, bottles, and/or cartridges according to the laboratory waste disposal
procedures of the facility.

Supplies Screen
The Supplies Screen can be used to verify the supply and waste inventory before sample processing is
initiated or when a status indicator is displayed.
Use the Supplies Screen to update certain consumables and waste inventory.
Navigate to the Supplies Screen by selecting the Supplies icon on the Menu Bar of the Home page.
The Supplies Status button on the Processing Module Image also navigates to the Supplies screen for
the module selected.

The Module Bar on the Supply Screen is used to select an individual module to view supply status
information.
c-series Supplies Screen.
i-series Supplies Screen
¥ NOTE: screen depictions may vary depending on instrument

configuration and software version
On the Supplies screen, the operator can view the following information and perform the listed
functions:

Alinity c Alinity i
Percentage of bulk solutions. Percentage of bulk solutions.
Percentage of onboard solutions in sample Status of the reaction vessel (RV) waste.
wash solution area.
Status of RVs.
Status of liquid waste in the high-
concentration waste bottle (if installed). The Operator can update bulk solutions, RV’s and
RV Waste.
Status of ICT module.
The Operator can update the inventory for

bulk solutions, onboard solutions in sample
wash solution area, the liquid waste, and the
ICT module.
The c-series and the i-series calculate the supply volume and the percent-remaining information on
required tests for samples that have been scheduled on the reagent and sample manager.
Status Bar
The Status Bar displays a graphical representation of the status and total remaining supply, available
waste capacity or total remaining supply depending on the supply item.
For c-series Bulk Solutions the statuses are indicated by the following colors:
· Green = OK
· Yellow = Low Level or Overridden
· Red = Empty, Lot Expired
For i-series Bulk Solutions the statuses are indicated by the following colors:
· Green = OK
· Yellow = Low Level or Overridden
· Red = Empty, Lot Expired, Stability Expired
For ICT Module the statuses are indicated by the following colors:
· Green = OK
· Yellow = Overridden, Exceeded
· Red = Lot Expired, Update Required

In the waste areas statuses are indicated by the following colors:
· Green = OK
· Yellow = Near Capacity
· Red = Full
· Update Supplies
For RV’s statuses are indicated by the following colors:
· Green = OK
· Yellow = Low Level
· Red = Empty
Update Supplies
After reviewing the supply status, replace consumable inventory or empty the waste as indicated.
Then update the supply information so the system can accurately track the onboard supply inventory
and/or waste.
ZĞƉůĂĐŝŶŐƵůŬ^ŽůƵƟŽŶƐ
For Bulk solutions that have an onboard stability claim, onboard stability tracking occurs when
the bottle is replaced and is updated. Tracking and replacement is performed from the Supplies
Screen. Use the bar code scanner to scan the bar code on the new bulk solution bottle and the system
automatically updates the bulk solution with the lot number and expiration date of the new bottle.
ZĞƉůĂĐĞƵůŬ^ŽůƵƟŽŶƐĂŶĚh ƉĚĂƚĞ/Ŷǀ ĞŶƚŽƌǇ
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.
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 reservoir bottle must be
empty. Perform quality control testing before assay processing
¥ NOTE: The instrument will give a message code if the operator attempts
to load a new lot of ICT reference solution and those conditions are not
met.

¥ For the Bulk Solution Replacement Procedure refer to the Alinity ci-
series Operations Manual Section 5 Operating Instructions subsection;
following location:
empty the waste>Consumable inventory management>Replace bulk
solutions and update the inventory
ƵůŬ^ŽůƵƟŽŶWĞƌĐĞŶƚĂŐĞ
Supply Status 100%
¥ Note: the percentages apply to all supplies except for i-series Wash Buffer.
That supply involves a dilution being made and percentages include
diluted product in additional reservoir

Supply Status 50%

At this point, transfer of the entire bottle
in the door to the reservoir will occur.
A flush will also occur.
THEN:
Supply Status 50%
Supply Status 20%

Low alert is triggered
and a new bottle should be
placed in the door.
¥ NOTE: Bulk solution percentage calculations are not applicable to i-series

wash buffer.

RV Waste
The RV waste container can hold 1000 RVs (5 hours of run time at 200 RVs per hour).
Remove and discard the biohazard bag and its contents according to the laboratory biohazard waste
disposal procedures of the facility.
Once the waste container is removed, the system counts RVs. The waste chute holds 50 RVs before
the system operations is paused. The waste chute total capacity is 208 RVs (30 minutes of run time
when the waste container is removed during assay processing).
The biohazard bag must fit snugly and must be opened fully in the RV waste container so that reaction
vessels can drop freely into the container.
¥ Refer to Alinity ci-series Operations Manual Section 4 Performance

characteristics and specifications for biohazard bag specifications.

following location:
-Sample processing>Prepare for operations>Replenish the inventory and

empty the waste>Consumable inventory management>Remove the RV
waste and update the inventory (i-series)

ĐƟǀ ŝƚǇϭ
Verify the consumable supply and
waste inventory
1. From the Supplies Screen, verify the consumable supply and waste inventory levels for both the c
and i systems.
ĐƟǀ ŝƚǇϮ
Replace required consumables and empty waste
1. Locate the procedure(s) needed to replace any required consumable, or empty waste, in the online
Operations Manual.
2. Replace and update any required consumables.
3. Empty any required waste and update.

Other Consumables and Accessories

Sample cups
Sample cups are 1400 µL disposable containers that hold samples.
Volume graduation marks at 125 µL, 500 µL, and 1400 µL eliminate the need to pipette with
precision.
To facilitate the positive identification of samples, sample cups can be placed in sample tubes that
have bar code labels.

Racks
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:
1. 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.
2. 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.
3. Sample Rack. Bar-coded for identification. Holds six primary tubes, aliquot tubes, or sample cups.
Any combination of tubes and cups can be in used in the rack.
4. Sample gauge: used to verify that the amount of sample in an aliquot tube exceeds 8mm.

Trays
Trays are accessories that are used to hold multiple racks of samples, calibrators, and controls and to
hold reagent cartridges.
Trays of racks and cartridges are loaded on the reagent and sample manager. Each tray holds a
maximum of five racks or cartridges one at a time.
Empty trays may remain on the loading area to create five positions to load racks or cartridges one at
a time.
ĐͲƐĞƌŝĞƐZĞĂŐĞŶƚĂƌƚƌŝĚŐĞǁ ŝƚŚĞŵƉƚǇďŽƩůĞƐ
The c-series Reagent Cartridge, Black (Large), is a single-use cartridge that contains two empty, black
reagent bottles that can be filled with saline, user-defined sample diluents, and user-defined reagents.
There is also an Alinity c-series Reagent Cartridge, Clear (Large), designed so that the liquid level in
the bottle is visible. Additionally, a line to indicate the maximum fill volume was added to each bottle
to help prevent overfilling the cartridge, which could lead to damage of the reagent carousel.
When the bottles are filled and labeled with a one-dimensional (1D) reagent bar code, the cartridge
can be loaded in the reagent carousel.
· The R1 bottle is the larger bottle and has a maximum fill volume of 74 mL.
· The R2 bottle is the smaller bottle and has a maximum fill volume of 47 mL.

Controls
Controls are available as single-constituent and multi-constituent controls. Single-constituent
controls as assay-specific samples that contain known concentrations of an analyte. Multi-constituent
controls are samples the contain multiple analytes. Some controls can be stored for use in the reagent
carousel.
To identify the controls that are required for an assay, see the assay documentation.
Calibrators
A variety of single-constituent and multi-constituent calibrators are used on the Alinity c-series.
Single-constituent calibrators are used on the Alinity i-series.
Some calibrators can be stored in the reagent carousel. To identify the calibrators that are required for
an assay, see the assay documentation.

Alinity ci-series Calibrator/Control Replacement Caps

Replace the original caps on calibrator and control vials that are loaded on the reagent and sample
manager for calibration and control testing.
The replacement cap seals the vial to prevent leakage when the vial is removed from the system and is
stored in an external refrigerator.
The original cap is not used to prevent analyte cross- contamination.

Reagents
Reagent kits are one or more cartridges that contain all the necessary reagent components for an
Alinity ci-series assay.
Abbott prepackaged reagent cartridges contain a two-dimensional bar code. Each bar code includes
the following information:
· Reagent identifier
· Reagent serial number
· Test size (number of tests for each cartridge)
· Expiration date
· Onboard stability time
· Master calibration information for assays that use the 2-point adjustment calibration method (only
for Alinity i-series)
Reagent Cartridge
Alinity i reagent cartridge: Provides the necessary components for an Alinity ci-series
chemiluminescent microparticle immunoassay assay. Each reagent bottle in the reagent cartridge
contains an integrated septum unless otherwise indicated in the assay documentation.
Alinity c reagent cartridge: Provides the necessary components for an Alinity ci-series
photometric or potentiometric assay.
Alinity Reagent Replacement Cap: Seals a reagent cartridge to prevent reagent leakage when the
cartridge is removed from the system and is stored in an external refrigerator.
Reagent cartridges can be stored on the system according to the assay-specific instructions.
Reagent cartridges are loaded into the reagent carousel. Reagent carousel inventory management
includes procedures to prepare and unload reagent carousel inventory items.
Use the Reagents screen to view and manage in-use inventory.

Prepare Reagents
¥ Note: Reagent handling instructions and mixing instructions should be
reviewed in the assay documentation prior to performing the assay.
Assay inserts are available at www.corelaboratory.abbott and/or through

AbbottLink (optional).
Reagent preparation varies per instrument series and assay.
· ALL i-series reagents must be mixed upon receipt into the laboratory. After mixing, reagents must
be stored for at least 1 hour prior to use to allow bubbles to dissipate. Some reagents require a
longer time for bubbles to dissipate, review specific package inserts for specifics.
· Mixing prior to loading a c or i-series reagent cartridge onto the RSM varies per assay, see product
specific documentation.
· Mixing instruction graphics are located on the reagent kit box and detailed instructions are provided
in the assay documentation.
· A reagent bottle that has a yellow cap requires special preparation.

· Black bottles may be used because some reagents are light sensitive.
· 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.
· Handle reagent properly to prevent evaporation, contamination, and maintain reagent integrity.
· When a reagent cartridge is scanned by the RSM bar code reader, the Alinity ci-series tracks and
maintains a record of the cartridge reagent lot number and expiration date. For this reason, do not
move open reagents from one Alinity ci-system onto another Alinity ci-system.
· Verify that the reagent bottles have not leaked.

· Verify that the reagent cartridges are within the expiration dates on the cartridge labels.
¥ Note: Do not use cartridges that are expired
¥ For instructions for reagent handling and use, see the assay
documentation.
¥ For instructions to prepare reagent cartridges for use refer to the Alinity
Reagent and sample management
following location:

empty the waste>Reagent carousel inventory>Prepare reagent cartridges.

Load Reagents
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.
Trays can be loaded in routine positions or priority positions on the reagent and sample manager
(RSM). Empty trays may remain on the loading area to create five positions to load racks or cartridges
one at a time.
The RSM status must be in Running for the cartridges to load into the reagent carousel. Confirm the
status indicator above the bay position is displaying the proper status for loading.
· Routine loading: status indicator is not illuminated, which indicates that the position is available
· Priority loading: status indicators above the bay positions to load are blue, which indicates that the
positions are available.
If the position on the RSM does not contain a tray, load the cartridge into a tray and slide the tray into
the RSM.
Hold the cartridge handle, and slide the cartridge into a routine position or a priority position on the
RSM until a green status indicator illuminates.
Some assays require two reagent cartridges. These reagent cartridges are indicated with 1/2 and 2/2
on them. Both reagent cartridges must be loaded, but they do not need to be inserted into adjacent
positions. After the reagent cartridges are loaded on the RSM and the bar code reader scans the bar
code label, the system software links the two reagent cartridges as a set.
For products that have an onboard stability claim, onboard stability tracking occurs after the cartridge
is scanned by the bar code reader.

Unload Racks and Cartridges from Reagent

Carousel to RSM
When a reagent carousel inventory item has a status of Empty, LLS Error, or Expired, the system
initiates a cartridge unload request.
There may also be times when the operator wants to initiate a cartridge unload request such as; to put
the reagent back in storage (if not being used) or to conduct troubleshooting steps.
This procedure is performed from the Current tab of the Reagent screen or Reagent status
screen. First confirm that the carousel item to unload is not required for tests that are in process and
that the RSM status is Running.
After the cartridge is unloaded from the reagent carousel and is removed from the RSM, the timer for
onboard stability tracking stops
¥ For instructions to remove reagent cartridges from the Reagent Carousel

refer to the Alinity ci-series Operations Manual Section 5 Operating
Instructions subsection; Reagent and sample management
following location:
-Sample processing>Prepare for operation>Replenish the inventory

and empty the waste>Reagent carousel inventory>Unload racks and
cartridges from a reagent carousel to the RSM

Reagent Screen
The operator can easily view the status of reagents on board the system.
The Reagent status button on the Processing Module Image on the Home screen will indicate if a
supply is low.
· Green - reagent is OK, Mixing, Overridden, or Disabled

· Yellow - reagent volume of one or more reagent carousel items is below the configured low alert
setting or Overridden
· Red - one or more reagent carousel items have a cartridge status of Expired, LLS Error, Empty,
No Assay, Incomplete, BC Fail, Load Error, or Undefined. A reagent status of Empty triggers a red
status only if no additional tests for the reagent are present on the module.
Selecting the Reagent status button, will navigate to Current tab on the Reagent screen for the
module selected.
Selecting the Reagents icon in the Menu Bar will navigate to Current tab on the Reagent screen
view all.
From the Reagents screen the operator can view information for cartridges and racks that are loaded
in the reagent carousel. This includes information for reagent carousel inventory items such as:
· an estimated amount of tests that remains calibration status for the assay that uses the reagent
cartridge
· lot number
· expiration date
· number of onboard stability days that remain for items that have an onboard stability claim

· load or unload status

· number of scheduled tests
The operator can perform the following functions:
· Search for a specific cartridge or rack based on specified search criteria.

· Access reagent cartridge details.
· Unload a cartridge.
· Print a reagent report.
Current Tab
The Current tab of the Reagent screen displays:
· A list of cartridges and racks that are currently loaded on the system for all modules.
· A graphical representation of the reagent carousel for individual modules that indicates the position
and status of the cartridges and racks.
Reagent Screen: screen depiction may vary depending on instrument configuration and software
version
The reagent carousel inventory on the Reagent Screen includes:
· Reagents.
· Onboard solutions.
· Diluents.
· Maintenance solutions.
· Calibrators.
· Controls.
The status of reagents and racks in the reagent carousel positions is indicated by the colors described
in the table below:

Position Color Description

White No cartridge is loaded in the position.
Green A cartridge that has a status of OK or Mixing (only for
i-series) is loaded in the position.
Yellow A cartridge that has a status of Low Alert, Overridden, or
Disabled is loaded in the position.
This status also includes reagents that have a lot or onboard

stability expiration within 1 hour.
Red A cartridge has an error condition (such as LLS Error or Load
Error) or a status of Expired, Empty, No Assay, Undefined,
Incomplete, or BC Fail. The text in the list associated with the
item is displayed in red.
Purple An onboard vial rack is loaded in the position.

Reagent Cartridge Detail

From the Reagent Cartridge Details screen the operator can perform the following functions:
· Disable a reagent cartridge.

· Enable a reagent cartridge.
· View or print an assay insert (if connected to AbbottLink).
Historical Tab
The Historical tab displays a list of cartridges and racks that are currently loaded on the system and
were previously loaded on the system.
Module Specific Reagent Screen

To display the reagent carousel inventory for one module, tap a Module button.
ĂƌƚƌŝĚŐĞ^ƚĂƚƵƐ/ŶĨŽƌŵĂƟŽŶ
Cartridge status information is used to determine the status of each reagent carousel inventory item
and to determine if any problems with onboard inventory items have occurred.
The Alinity ci-series has the following cartridge statuses:
· BC Fail.
· Undefined.
· Load Error.
· Incomplete.
· No assay.
· Empty.
· LLS Error.
· Expired.
· Disabled.
· Low Alert.
· Overridden.
· Mixing (i-series).
· OK.

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 Alinity ci-series has the following load statuses:
· Unload error.
· Load Error.
· Scheduled unload.
· Scheduled load.
· Partially unloaded
· Scanning.
· Unloading.
· Loading.
· Blank.
· Processing.
ĐƟǀ ŝƚǇϯ
Verify reagent inventory
1. From the Reagent Screen, verify the reagent levels for both the c and i systems.
2. Select an assay and record the number of tests available for each reagent cartridge onboard.
ĐƟǀ ŝƚǇϰ
Load reagent
1. Locate the procedure(s) in the online Operations Manual.
2. Prepare and load reagent cartridge(s) into a tray(s).
3. Load the tray(s) onto the reagent and sample manager.

ĐƟǀ ŝƚǇϱ
Unload reagent
2. Select a reagent cartridge and unload the reagent cartridge from the reagent carousel.
3. Unload the reagent from the reagent and sample manager and store the reagents.
ĐƟǀ ŝƚǇϲ
View or Print Assay Insert
2. Identify an assay and view or print the assay insert.
This activity requires that the system is connected to AbbottLink. If the system is not connected to
AbbottLink, the activity cannot be performed.

Review
1. Select all of the following that are bulk solutions used on an Alinity c Processing Module. (Select all
that apply)
a. Detergent A
b. Acid Wash
c. Trigger Solution
d. Alkaline Wash
e. Concentrated Wash Buffer
f. ICT Reference Solution
2. What size tube does the sample onboard wash solutions use?
a. 16mm x 100mm
b. 3mm x 20mm
c. 30mm x 120mm
3.Reaction Vessels (RVs) can be added at any time as long as the inventory allows.
a. True
b. False

4. Select all of the following scenarios that alert you when you need to replace and update the bulk
solution inventory. (Select all that apply)
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. When a bottle has expired
d. There are no such alerts
5. Select all of the following items that a reagent carousel inventory may include: (Select all that apply)
a. Reagents
b. Bulk solutions
c. Onboard solutions
d. Calibrators
e. Controls

6.Which one of the following functions can the operator perform on the Reagents screen?
a. Replenish RVs
b. Update the inventory for bulk solutions
c. Verify the supply and waste inventory
d. Access reagent cartridge details
7. Empty trays may remain on the loading area to create five positions to load racks or cartridges one
at a time.
a. True
b. False
8. When replacing the sample onboard wash solutions, it is the operator responsibility to place the
tubes in the correct location.
a. True
b. False

9. Which of the following functions can the operator perform on the Supplies screen? (Select all that
apply)
a. Access the reagent cartridge details
b. Verify the supply and waste inventory
c. Update the inventory for bulk solutions
d. Replenish RVs
10. Select all of the following that are bulk solutions used on an Alinity i Processing Module. (Select all
that apply)
a. Detergent A
b. Trigger Solution
c. Pre-Trigger Solution
d. Alkaline Wash
e. Acid Wash
f. Concentrated Wash Buffer

4 Reagent and Sample Manager
ϯ ϬŵŝŶƵƚĞƐ
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
4-1 Alinity ci -series Global Customer Training | Internal Use Only | ADD-00066223
Reagent and Sample Manager
K ďũĞĐƟǀ ĞƐ
o Identify the primary components of the RSM
o Explain the meaning of RSM Status Indicators
o Identify Priority positions

are:
Section 1 Use or Function subsections; Alinity ci-series hardware

overview

Z^D &ƵŶĐƟŽŶƐ
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.
¥ Note: On a multi-module system, sample racks, calibration and control

racks, and reagent cartridges for c-assays and i-assays can be loaded on
any module RSM and will be routed accordingly.
The RSM performs the following functions:
· Lifts racks and cartridges from the loading area and moves them past the bar code reader
· Positions racks and cartridges for the bar code reader to identify samples, reagents, and solutions
· Moves racks and cartridges to the appropriate processing module or returns them to the loading
area
1. 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.
2. RSM bar code reader: An imaging camera that reads bar code labels on samples, racks, and
cartridges.
3. 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.
4. Loading area: Positions racks and cartridges for loading and unloading.

Loading Area
The loading area holds racks and cartridges for routine and priority processing. Each processing
module includes one loading area.

Identifier Component Description

1 Priority button Temporarily assigns an RSM position as a priority position.
2 Priority Designated with a blue status indicator. Racks or cartridges
position inserted in this position are processed before other positions.
3 Status Indicate the status of sample processing and when samples and
indicators reagents can be accessed.
4 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.
5 Position Holds one rack or cartridge. Each processing module has 25
positions.
6 Bay Holds trays that are used to position racks and cartridges for assay
processing. Each processing module contains five bays.

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.
Status Indicator Lights
Indicator
Description
Condition
Indicators Off No rack or cartridge is inserted in the position. [1]
Green (Steady) The rack or cartridge is inserted but is not in process. The rack
or cartridge can be accessed. [2]
Amber (Steady) The rack or cartridge is in process. The rack or cartridge cannot
be accessed. [4]
Green (Blinking) Processing is completed. The rack or cartridge can be accessed.
Amber (Blinking) Unloading of a cartridge or vial rack is in process. The position is
reserved and is unavailable to load a rack or cartridge.
Amber and Green A bar code scan error or other error occurred. The rack or
(Alternating) cartridge can be accessed

Indicator
Description
Condition
Blue The RSM position is designated as a priority position. [3]
¤ NOTE: Priority positions can be configured in the

software as permanent positions or can be designated
on the fly by using the Priority button.
WƌŝŽƌŝƚǇƵƩŽŶ
Located on the left side of the loading area of a processing module is the priority button.
The priority button is used to create a temporary priority position.

ƌĞĂƚĞĂdĞŵƉŽƌĂƌǇWƌŝŽƌŝƚǇWŽƐŝƟŽŶ
1. Press the priority button. The button will illuminate.
2. Insert a rack, cartridge, or tray into any position on the loading area of the specific processing
module.
· 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 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 deactivate the RSM
priority button before the time-out expires, press the priority button again
¥ NOTE: On a multimodule system with more than one c-system or more

than one i-system, if a user wants to direct a sample or reagent to a
specific module it can be done by creating a temporary priority position
on the desired module and then loading the sample rack or reagent into
that position.

Review
1. Select the status indicators that allow the operator to access the rack or cartridge. (Select all that
apply)
a. Amber and Green (alternating)
b. Amber
c. Green Blinking
d. Green Steady
2. Identify the RSM Indicator Status that matches the following status definition-The rack or cartridge
is inserted, but processing has not begun. The rack or cartridge can be accessed.
a. Indicators Off
b. Blue
c. Alternating Green and Amber
d. Green (steady)
e. Green (blinking)
3. Identify the item, or component, that matches this description-A position on the RSM designated
with a blue status indicator. Racks or cartridges inserted in this position are processed before other
positions.
a. Bay
b. Tray
c. Priority Button
d. Priority Position

5 Daily Maintenance
ϭŚŽƵƌ
Module Topics
A thorough maintenance program minimizes downtime, maintains records for inspection and
accreditation, and maintains system performance to provide optimal test results. This module
describes what happens during Daily Maintenance, why it is so important to the operation of your
instrument and how to perform the procedure.
· Performing daily maintenance
K ďũĞĐƟǀ ĞƐ
o View Maintenance procedures
o Identify consumables used in Daily Maintenance
o Perform Daily Maintenance

are:
Section 9 Service, Maintenance and diagnostics subsections; Maintenance

and diagnostics, Procedures Log screen and Maintenance procedure
descriptions

Daily Maintenance
Daily Maintenance Description

Importance
The appropriate service, maintenance, and diagnostics of the system are some of the most important
aspects of a complete quality assurance program. A thorough service, maintenance, and diagnostic
program:
· Minimizes downtime.
· Maintains records for inspection and accreditation.
· Maintains system performance to provide optimal test results
When scheduling and performing maintenance procedures:
· Schedule maintenance procedures for times when the workflow is slow.

· Verify that adequate supplies are loaded, or are available to load, on the system before initiating a
maintenance procedure.
· Perform procedures within a maintenance category on different shifts or days. To avoid scheduling
these procedures for the same day, perform some of them early to stagger the schedule.
¥ NOTE: All maintenance procedures must be completed on or before the

due date.
ĞƐĐƌŝƉƟŽŶ
Maintenance procedures are grouped first by module type and then by category. The type of module
determines the categories and procedures that are available.
To view or perform a maintenance procedure begin by selecting the Procedures icon in the Menu
Bar.
· If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.

Daily Maintenance
Procedures Screen
The Procedures screen displays maintenance and diagnostic procedures that can be performed. On
the Procedures screen, tap a Module button.
The Maintenance tab displays maintenance procedures that can be performed for a selected
module. Each maintenance category is represented by a tab on the right side of the Maintenance tab
of the Procedures screen.
· The To Do tab displays scheduled procedures for the selected module.

· The All tab displays all procedures for the selected module.
· Each additional tab represents a frequency (for example, Daily or Weekly).
Any procedure that is displayed can be performed even if it is not scheduled.
A trained operator can perform the following functions on the Procedures screen:
· Access details for a maintenance procedure or a diagnostic procedure.

· Perform a maintenance procedure or a diagnostic procedure.
· Print a maintenance procedure or a diagnostic procedure.
· Access maintenance logs or diagnostic logs.
· View In-process maintenance procedures or in-process diagnostic procedures.
· View scheduled maintenance procedures to perform by category.
· View available diagnostic procedures to perform by category.
After initiating a maintenance or diagnostic procedure, follow step-by-step instructions through the
procedure to completion.
Procedure Key
A procedure key is provided for use with a maintenance procedure, a diagnostic procedure, or a
component replacement procedure.
Setting information can be found on the Procedure Details flyout for each procedure.
There is a procedure key on the Alinity c processing module, the Alinity i processing module, and the
system control module (SCM).

Daily Maintenance
When the key is positioned at the black dot it is OFF. When the key is positioned at the white dot it is
ON.
Setting Description
Required On The procedure key must be in the On position to perform the
procedure.
Optional On The procedure does not require the covers to be opened. If the
cover is not open, the procedure key can be in the Off position. If
the covers are opened for observations, the key must be in the On
position.
Off The procedure key is not required to perform the procedure.
The covers can be opened without affecting the progress of the
procedure.
¥ NOTE: When procedures are performed with the procedure key

positioned at the On setting, important safety features are bypassed and
the operator may be exposed to one or more of the potential hazards.
Refer to the Operations Manual for additional information.

Daily Maintenance
Maintenance Help
The online Operations Manual (Help) contains a general procedure on how to perform all
maintenance and diagnostic procedures.
Detailed instructions are included with each individual procedure.
Some procedures have pictures and videos to use as aids to perform the procedure. The Show Video
button and the Show Picture button are displayed when pictures and videos are available.
Daily Maintenance Procedure

Daily maintenance procedures are required on the c-series and i-series processing modules.
The daily maintenance procedures are:
· 5501 Daily Maintenance (c-series).

· 2500 Daily Maintenance (i-series).
Supplies
ĐͲƐĞƌŝĞƐD ĂŝŶƚĞŶĂŶĐĞ^ŽůƵƟŽŶƐ
The Alinity c-series maintenance solutions are supplied as a three component kit.
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.

Daily Maintenance
The Cleaning Solution is supplied as a lyophilized material with a diluent. The reconstituted cleaning
solution is added to the small bottle of the maintenance cartridge.
During daily maintenance, the cleaning solution is used to clean the sample and reagent probes,
mixers, ICT Probe, and ICT Module.
ŝͲƐĞƌŝĞƐWƌŽďĞŽŶĚŝƟŽŶŝŶŐ^ŽůƵƟŽŶ
Probe conditioning solution is a solution that contains recalcified human plasma. This solution
conditions the probe to prevent the nonspecific binding of analytes in the probe.
Tasks
The c-series Daily maintenance procedure completes the following tasks:
· Flushes the water lines of the sample, the reagent, and the cuvette washer.
· Exchanges the water in the water bath.
· Adds Water Bath Additive to the water bath.
· Washes the ICT module with ICT Reference Solution and Cleaning Solution.
· Drains and fills the ICT Reference Solution cup.
· Washes the sample and reagent probes and the mixers with Acid Probe Wash and Detergent A.
· Cleans the sample probe, the R2 probe, and the mixers with Cleaning Solution.
· Cleans the sample probe exterior (only for whole blood).
The i-series Daily maintenance procedure completes the following tasks:
· Cleans and conditions the sample pipettor probe.

· Cleans wash zone 1 probes and wash zone 2 probes with 0.5% sodium hypochlorite solution.
· Flushes and primes the Pre-Trigger Solution and the Trigger Solution.
¥ NOTE: This maintenance procedure can be performed concurrently on

systems that have redundant Alinity i processing modules.

Daily Maintenance
Procedure Overview
Specific instrument statuses are required to perform maintenance. These statuses are defined in the
maintenance procedure.
The procedure key setting for daily maintenance on the c-series is Required On.
The procedure key setting for daily maintenance on the i-series is Optional On.
The Probe conditioning solution (i-series) and c-series Maintenance Solution must be loaded into
the reagent carousel before starting the daily maintenance procedures. This is done by loading the
cartridges into the RSM while the RSM is in a Running status.

Daily Maintenance
To start Daily Maintenance, on the right side of the Procedures screen, tap either the To Do tab or the
Daily tab. Under Procedure, tap the Daily Maintenance procedure.
Then Tap Perform to view the Maintenance procedure.
· Tapping Quit at the first screen to exit the procedure will not change the module status to Stopped.
· Tapping Quit on any other screen will stop the module.
To perform the procedure, tap the Proceed user input button and follow the instructions in the
instructions box.
· An operator can leave a maintenance or diagnostic procedure while it is running to perform other
activities in the software. Tap any icon on the menu bar to leave the procedure.
· To return to a procedure, tap on the In Process tab, tap on the procedure in process and then tap
continue.
¥ For the Daily Maintenance Procedure refer to the Alinity ci-series

Operations Manual Section 9 Service, maintenance, and diagnostics
subsection; Maintenance and diagnostics
following location:
-Sample processing>Prepare for operation>Perform daily

maintenance>Perform a maintenance procedure or a diagnostic
procedure

Daily Maintenance
D ĂŝŶƚĞŶĂŶĐĞĂŶĚ ŝĂŐŶŽƐƟĐ
Procedures Statuses
Maintenance and diagnostic procedure status refers to the completion status of a procedure.
Status Description
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 The procedure in process requires an operator response.
response
Not performed The maintenance procedure was not performed on the date due.
ĐƟǀ ŝƚǇϭ
Perform Daily Maintenance
1. Begin daily maintenance on both the c and i modules.
2. Leave the procedure while it is in process.
3. Return to the daily maintenance procedure and complete the procedure.
If you are in a multi-day classroom environment, you will complete this task at the start of each day

Daily Maintenance
Review
1. Select all of the valid Alinity ci-series maintenance completion statuses: (Select all that apply)
a. Scheduled
b. Awaiting user response
c. Failed
d. Drying
2. 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
3. Only scheduled maintenance procedures can be displayed and performed from the procedures
screen.
a. True
b. False

Daily Maintenance
4. Identify all of the benefits of a thorough service, maintenance, and diagnostic program. (Select all
that apply)
a. Maintenance records for inspection and accreditation
b. Archives patient results
c. Minimizes downtime
d. Maintains system performance to provide optimal test results
5. Daily maintenance procedures are required on the c-series and i-series processing modules.
a. True
b. False
6. 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.
a. True
b. False

6 ĂůŝďƌĂƟŽŶ
ϭ͘ ϱŚŽƵƌƐ
Module Topics
The Alinity ci-series offers highly automated calibration management. In this module, you will
explore:
· Calibration Guidelines
· Processing Calibration Samples
· Calibration Statuses
· Calibration Results

Calibration
K ďũĞĐƟǀ ĞƐ
o Explain the need for calibrations
o Identify Calibration Types
o Describe Calibration Sample Processing Rules
o Describe the Calibration Status Details screen
o Fail a calibration
o Create a calibration order
o Describe the Orders and Order Details screen
o Prepare and load vials into vial racks for immediate use
o Initiate a calibration run
o View calibration status and history
o Archive calibration results

are:
Section 1 Use or Function subsections; Required consumables and

Required accessories.
Section 5 Operating Instructions subsections; Specimen, calibration, and

control orders and Reagent and sample management
Section 6 Calibration procedures

Calibration
ĂůŝďƌĂƟŽŶƐ
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.
The Alinity ci-series has guidelines for when a mandatory assay calibration and optional assay
calibration should be performed
D ĂŶĚĂƚŽƌǇĂƐƐĂǇĐĂůŝďƌĂƟŽŶŵƵƐƚďĞƉĞƌĨŽƌŵĞĚǁ ŚĞŶ͗
· 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.
K ƉƟŽŶĂůĂƐƐĂǇĐĂůŝďƌĂƟŽŶŵĂǇŶĞĞĚƚŽďĞƉĞƌĨŽƌŵĞĚǁ ŚĞŶ͗
· 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.
Before performing sample processing for the first time, calibrate all assays.
A variety of single-constituent and multi-constituent calibrators are used on the Alinity ci-series.

Calibration
Alinity i Processing Module calibrator
Include Alinity i Processing Module single-constituent calibrators that are used in the calibration of
i-series assays.
Alinity c Processing Module calibrator
Include single-constituent and multi-constituent calibrators that are used in the calibration of c-series
photometric assays.
Alinity c Processing Module ICT calibrators
Used in the calibration of c- series potentiometric assays.
Running all levels of appropriate controls is recommended when an assay is calibrated.
ZĞĐŽŵŵĞŶĚĞĚWƌĂĐƟĐĞ
Many inspection agencies require calibration at regular intervals, which may be met by regular
replacement of expired reagents. Most laboratories have requirements in addition to these
regulations. Talk to your Abbott technical representative for assistance.

Calibration
ĂůŝďƌĂƟŽŶdǇƉĞƐ
Calibration types and methods define the system-specific processes that are used to create a
calibration curve or determine a cutoff value.
For information about calibration types and methods for an assay, see the assay documentation.
c-series
The type and method of calibration are defined in each assay parameter file.
The photometric calibration methods on the Alinity c-series use measured absorbance values to plot a
calibration curve or to determine a cutoff value.
The photometric assays calibration types are:
· Full calibration
· Adjustment calibration
The names refer to whether a calibration curve is created or adjusted.
The potentiometric calibration method is used to calculate results for the ICT assays of sodium (Na+),
potassium (K+), and chloride (Cl-).
i-series
The type and method of calibration are defined in each assay parameter file and are specific to the
assay.
The calibration types on the i-series are:
· Full calibration (6 points)

· Adjustment calibration (2 points)
· Index calibration (1 or 2 points)
· Reference method

Calibration
ĂůŝďƌĂƟŽŶ^ĂŵƉůĞWƌŽĐĞƐƐŝŶŐ
When multiple reagent lots for an assay are loaded on the system and before the sampling process for
a calibration order begins, the system determines which lots to calibrate by using:
· the calibration status of the reagent lot

· the selected order options for the reagent and module
¥ NOTE: For c-series photometric assays that are configured to perform

calibrations by cartridge, the reagent lot is composed 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.
ZĞĂŐĞŶƚ^ĞůĞĐƟŽŶK ƉƟŽŶŝƐD ŽĚƵůĞ

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:
· 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.
· The system calibrates all reagent lots loaded on the system when all reagent lots for the assay have a
· 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.
ZĞĂŐĞŶƚ^ĞůĞĐƟŽŶK ƉƟŽŶŝƐƵƚŽ
If the Reagent Selection option is Auto, then for all modules 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
· The system calibrates all reagent lots loaded on the system when all reagent lots for the assay have a
· 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.

Calibration
ĂůŝďƌĂƟŽŶ^ƚĂƚƵƐ
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.
An assay calibration run must pass calibration verification before the system stores the calibration.
Unless otherwise indicated, calibration statuses are displayed on the Current tab and the Historical
tab of the Calibration Status screen. The calibration status can also be viewed from the Home
Screen.
· Green calibration is OK
· Yellow calibration will expire in one hour
· Red calibration is expired
The CAL icon in the Menu Bar also alerts the operator to certain calibrator statuses:
· An amber badge is displayed on the CAL icon when a calibration is within 1 hour of expiration.
· A red badge is displayed on the CAL icon when a calibration has expired or failed.
The table below displays the calibration statuses in the order in which they sort. The system displays

Calibration
one of the following calibration statuses for each calibration curve.
Status Description
Failed One of the following occurred:
· The calibration failed an assay-specific calibration parameter

or assay specific calibration validity checks.
· The calibration did not complete successfully due to a
hardware error.
· The operator manually failed the calibration.
Expired The calibration interval has been exceeded.
No Cal One of the following occurred:
· A calibration has not been run for the reagent lot, or the
reagent lot and cartridge combination, that is loaded on the
system.
· One or more c-series assay parameters were edited.
· The c-series parameter that designates whether to calibrate an
assay by lot or cartridge was edited.
· One or more calibrator concentration values were edited.
This status is displayed only on the Current tab of the

Calibration Status screen.
Pending QC · The system is configured to require QC to run after a
calibration is generated.
· The calibration was completed successfully and no control
level has completed.
Overridden The operator has manually overridden an expired calibration.
Overridden Lot The system is configured to track the calibrator lot expiration date
and the operator has manually overridden an expired calibrator
lot.
In Process The calibration is currently in process.
This status is displayed only on the Current tab of the Calibration

Status screen.
Active The calibration completed successfully and is not expired.
Inactive This status is displayed only on the Historical tab of the
Calibration Status screen when one of the following situations
occurs:
· A previously active calibration is replaced by a more recent

calibration.
· The number of supported active calibrations for a specific
processing module, assay, and reagent lot or reagent lot and
cartridge combination has been exceeded. The oldest active
calibration becomes inactive.

Calibration
s ŝĞǁ ĂƐƐĂǇĐĂůŝďƌĂƟŽŶƐƚĂƚƵƐ
To determine the calibration status for the day, you must use the View the assay calibration status
procedure.
1. On the menu bar, tap CAL.
4 The Current tab of the Calibration Status screen displays the calibration data for all modules.
2. To display the data for one module, tap a Module button.
3. In the Status column, view the calibration statuses
¥ To View the Calibration Status refer to the Alinity ci-series Operations

Manual Section 5 Operating Instructions subsection; Calibration Review
¥ To locate the procedure using the online Procedure Map to refer to the
following location:
-Sample processing>Prepare for operation>View the assay calibration

status>View the assay calibration status.

Calibration
ĂůŝďƌĂƟŽŶ^ƚĂƚƵƐ^ĐƌĞĞŶ
On the Calibration Status screen, the operator can view a list of the calibration statuses for assays
and reagent lots that are loaded on the system.
· Search for specific calibrations based on specified search criteria.

· Access calibration details.
· Fail a calibration.
· Print a calibration report.
The Current tab displays the current calibration information for reagents loaded on the system
based on the last reagent scan.
The Historical tab displays all calibration information on the system for up to 3 months.

Calibration
ĂůŝďƌĂƟŽŶ^ƚĂƚƵƐ ĞƚĂŝůƐƐĐƌĞĞŶ
From the Current tab, use the Details function button to navigate to the Details screen for the
selected items on the current screen.
The Calibration Status Details screen displays the details of the assay, reagent, and calibrator
information that are used to generate a calibration.
On the Calibration Status Details screen, the operator can view the following information:
· Details for calibrations

· Calibration graphs only for c-series
The operator can fail a calibration.
· This procedure fails a calibration that has a status of Active or Pending QC, and prevents subsequent
result generation from the calibration for existing control and patient orders.
· The operator can only fail a calibration curve from the following statuses:
4 Processing module: Stopped, Warming, or Idle
4 Reagent and sample manager: Stopped or Idle

Calibration
ĐƟǀ ŝƚǇϭ
s ŝĞǁ ĐĂůŝďƌĂƟŽŶƌĞƐƵůƚƐŝŶƚŚĞĂůŝďƌĂƟŽŶ^ƚĂƚƵƐƐĐƌĞĞŶ
1. View the assay calibration status for each reagent on the system.
4 Identify any calibration that will expire in the next 8 hours.
ĐƟǀ ŝƚǇϮ
s ŝĞǁ ĐĂůŝďƌĂƟŽŶĚĞƚĂŝůƐŝŶƚŚĞĂůŝďƌĂƟŽŶ^ƚĂƚƵƐ ĞƚĂŝůƐƐĐƌĞĞŶ
1. From the Calibration Status screen, access the Calibration Status Details screen for a c-series assay
calibration.
4 Locate the assay lot number of the reagent cartridge

4 Locate the lot expiration date of the reagent cartridge.
4 Review the calibration graph.
2. From the Calibration Status screen, access the Calibration Status Details screen for an i-series assay
calibration.
4 Review the calibration data.

Calibration
ĐƟǀ ŝƚǇϯ
&ĂŝůĂĂůŝďƌĂƟŽŶƵƌǀ Ğ
1. Locate the procedure(s) needed to fail the calibration curve in the online Operations Manual.
2. Fail the calibration identified by your facilitator.
ĂůŝďƌĂƟŽŶK ƌĚĞƌƐ
Order requests for specimens, calibrator samples, and quality control samples can be created
automatically or manually by an operator.
Calibrators come in vials and can be placed in a vial rack without an order.
If you have calibrators stored in the reagent carousel in an onboard vial rack and want to run the
calibration before a calibration is required, a manual order must be created.
ƵƚŽŵĂƚĞĚĂůŝďƌĂƟŽŶK ƌĚĞƌŝŶŐ
Automated calibration ordering is available by configuring the system parameters of the Alinity ci-
series.
Automated calibration orders are created in the following ways:
· When a bar code label from an onboard vial rack or a vial rack is scanned
· When the system software periodically evaluates the calibrator vials that are stored in onboard vial
racks in the reagent carousel (c- series only)
On multimodule systems, automated calibration orders are evaluated on all processing modules on
which the analyte can be run.
¥ Refer to the Alinity ci-series Operations Manual, Section 5 Operating

Instructions, subsection Specimen, calibration, and control orders for
complete information on Automated Calibration Ordering.

Calibration
D ĂŶƵĂůĂůŝďƌĂƟŽŶK ƌĚĞƌƐ
Orders Screen
The Orders screen can be accessed by tapping the Orders icon on the Menu Bar.
On the Orders screen, the operator can view specimen, control, calibration, and rerun orders. The
operator can perform the following functions:
· Find information about a specific order based on specified search criteria.

· Access the order information.
· Add a comment to a test order.
· Delete an order.
· Create a new specimen order, control order, or calibration order.
Order status information can be filtered by order type by selecting the
· Rerun tab
· Specimen tab
· Control tab
· Calibrator tab
The Details Function button navigates to the Details screen for the selected items on the current
screen.
On the Order Details screen, the operator can view the details for a specimen test order, a control test
order, or a calibrator test order.
The operator can add a comment to a specimen test order, a control test order, or an individual
calibrator test order.

Calibration
Create a Manual Order

The Create Order Function button navigates to the Create Order screen. On the Create Order
screen, the operator can manually create a Calibration Order.
To create a Calibration Order on the Create Order screen, begin by tapping the Calibration tab.
Then enter the required information as directed in the Operations Manual.
Running all levels of appropriate controls is required when an assay is calibrated.
Control orders and processing will be reviewed in a later training module.
ƌĞĂƚĞĂůŝďƌĂƟŽŶK ƌĚĞƌ
From HOME Screen Select:
· ORDERS Icon
· CREATE ORDER
OR
· Select CREATE ORDERS Icon if present
¥ NOTE: The Create Order icon is a configurable icon on the menu bar.
From Create Orders Screen:
· Select CALIBRATION Tab

· Type Rack and Position
4 Optional when barcoded samples used
· Select:
4 ASSAYS OPTIONS -optional:
§ Type/Select Calibrator Lot
4 REAGENT SELECTION
§ Default is Auto
4 DONE
4 Select:
§ ADD ORDER

Calibration
¥ To create a manual Calibration Order Request refer to the Alinity ci-

Specimen, calibration and control orders>Orders Screen>Create Order
screen
following location:
-Calibration>Order tests>Calibration orders>Create a calibration order

Calibration
Prepare and load vials into vial racks for

immediate use
For instructions for calibrator or control handling and use, see the assay documentation.
Verify that the calibrators are within the expiration dates on the vial labels. Do not use calibrators
that are expired.
Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before performing sample
processing. Use a new applicator stick for each vial to prevent cross contamination.
Place each opened vial in the white vial rack with standoffs so that the vial bar code is visible in the
rack window and the bar code fills the width of the window.
If the instrument is in Stopped, Idle, or Pausing status, initiate or resume processing.
4 Tap one or more of the processing modules or the RSM.

4 Tap one or more of the processing modules and the RSM.
2. Tap Run.
3. Prior to loading racks onto the RSM, verify the processing module(s) are in a Running or
Processing status.
Verify RSM Status Indicators indicate that the position is available. Hold the rack handle, and slide
the rack into a routine position or a priority position on the RSM until a green status indicator
illuminates.
¥ NOTE: Onboard vial racks are processed as priority racks regardless of

the position of the rack on the loading area of the RSM.

Calibration
If the position on the RSM does not contain a tray, load the rack into a tray and slide the tray into the
RSM. When loading racks onto a tray, ensure the rack is flush against the back of the tray.
In-use stability tracking occurs after the vial is scanned by the RSM bar code reader. After the vial is
removed from the reagent and sample manager, the timer for in-use stability tracking stops. For vials
that are stored on the system, the timer for in-use stability tracking stops when the vials are returned
to the reagent carousel
¥ To Prepare and load vial racks for immediate use, refer to the Alinity ci-
Reagent and sample management
following location:
-Sample processing>Load samples>Prepare and load vials into vial racks

for immediate use

Calibration
ĐƟǀ ŝƚǇϰ
ƌĞĂƚĞĂŵĂŶƵĂůĐĂůŝďƌĂƟŽŶŽƌĚĞƌĨŽƌĐĂůŝďƌĂƚŽƌƐƐƚŽƌĞĚŽŶďŽĂƌĚ
the system
1. Locate the procedure(s) needed to create a manual calibration order, in the online Operations
Manual or other available reference material.
2. Create a manual calibration order for an assay that has calibrators stored onboard the system.
· If calibrators are not stored onboard the system you cannot perform this activity.
· Your facilitator will identify the assay to calibrate.
ĐƟǀ ŝƚǇϰ
ƌĞĂƚĞŵĂŶƵĂůĐĂůŝďƌĂƟŽŶŽƌĚĞƌ;ƐͿ
1. Create manual calibration order(s) for assay(s) that do not have calibrators stored onboard the
system.
4 All assays with a calibration that is going to expire, select any other assay with reagent onboard,
or assay(s) identified by facilitator.

Calibration
ĐƟǀ ŝƚǇϱ
Prepare and load vials into vial racks
for immediate use
1. Load vials into vial racks for immediate use for all assays with a calibration that is going to expire,
or select any other assay with reagent onboard.
2. Load racks on the reagent and sample manager (RSM).
3. Initiate or resume sample processing.
ĐƟǀ ŝƚǇϱ
Unload vials from the reagent and sample manager (RSM)
1. After the calibration(s) from activity 5 are complete, unload vials from the reagent and sample
manager (RSM).
4 Confirm that the RSM status indicator is illuminated and blinking green, a steady green, or
alternating green and amber before unloading.
2. Return the vials to storage.

Calibration
ĂůŝďƌĂƟŽŶZĞƐƵůƚƐĂŶĚZĞƌƵŶƐ
Once calibration sample processing completes, review the calibration results and any alerts to
determine the status of the calibration.
· View calibration details and calibration graphs for the c-series only from the Calibration Status
Details screen.

Calibration

Calibration
&ĂŝůĞĚĂůŝďƌĂƟŽŶƵƌǀ Ğ
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. The previous calibration
remains active and the system software calculates patient and control test results from the existing
active calibration.
Review the Calibration Status Details screen to try and determine the cause of the failure.
ĐƟǀ ŝƚǇϲ
s ŝĞǁ ĐĂůŝďƌĂƟŽŶƌĞƐƵůƚƐ
1. View the calibration results from the calibrations generated in the previous activity in the
Calibration Status screen.
2. Also view the results in the Calibration Status Details screen.

Calibration
ĂůŝďƌĂƟŽŶ, ŝƐƚŽƌǇĂŶĚƌĐŚŝǀ Ğ
ĂůŝďƌĂƟŽŶ, ŝƐƚŽƌǇdĂď
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.
ƌĐŚŝǀ ĞĂůŝďƌĂƟŽŶƐ
The Alinity ci-series has a procedure to archive active and inactive calibrations, controls, or specimen
results to a USB flash drive.

Calibration
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 Mode.
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

Calibration
Review
1. Select all of the following functions the operator can perform on the Calibration Status screen.
(Select all that apply)
a. Fail a calibration
b. Print a calibration report
c. Calculate slope
d. Search for specific calibrations based on specified search criteria
e. A list of cartridges and racks that are currently loaded on the system
f. Access calibration details
2. The first step in creating a manual calibration order is tapping CAL on the Menu Bar.
a. True
b. False
3. Calibration is the process used to analyze calibrations of a known concentration, to record system
response values, and to plot measured values against the known concentration.
a. True
b. False

Calibration
4. Select all of the following steps to begin creating a calibration order: (select all that apply)
a. On the menu bar, tap Orders
b. On the Orders screen, tap Create Order
c. Tap Done
d. On the Create Order screen, tap Calibration tab
5. After an assay is installed that requires a calibration, an active calibration must be generated.
a. True
b. False
6. Select all of the following scenarios whereby mandatory calibration must be performed. (Select all
that apply)
a. Documentation that accompanies a new version of an existing assay file states that a calibration is
required
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. The calibration has expired
e. A new reagent number is used
f. A new assay file that requires a calibration is installed
g. Assay control values do not meet required specifications

Calibration
7. The potentiometric calibration method is used to calculate results for the ICT assays of
sodium(Na+), potassium (K+), and chloride (Cl-).
a. True
b. False
8. Which of the following represents a calibration type?
a. Electromotive force measurement
b. Slope calculation
c. Logit-4
d. Full calibration
9. Which 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

Calibration
10. Select all of the scenarios that may occur when you encounter a Failed calibration status: (select all
that apply)
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 operator manually failed the calibration
d. The operator has manually overridden an expired calibration
e. The calibrator was not completed successfully because of a hardware error
11. Select all of the following instrument statuses where you can fail a calibration: (Select all that
apply)
a. Warming
b. Idle
c. Stopped
d. Running
12. Which one of the following details can you view on the Calibration Status Details screen?
a. Slope calculation
b. Assay inserts
c. Calibration graphs (c-series)

7 Control Orders
ϭ͘ ϱŚŽƵƌƐ
Module Topics
The Alinity ci-series offers highly automated quality control management.
· The purpose and types of controls

· Processing quality control
· Quality control results
K ďũĞĐƟǀ ĞƐ
o Describe control sample processing
o Create a control order
o Prepare and load control vials for onboard storage
o Initiate a control run
o Describe quality control result flags
o Archive QC (Quality Control) results

are:

control orders and Quality control analysis

Control Orders
Processing Quality Control

Controls must be configured before they can be ordered or processed. Configuring a control will be
discussed in a later training module.
Controls can be stored onboard, in vials for immediate use, or run using sample cups.
Refer to the assay documentation for control requirements.
QC Processing
When the option to disable a reagent upon control failure is configured to On, and a control failure
occurs on one or more reagent cartridges, the failure prevents use of the cartridge.
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 whether controls are run for an assay for
each reagent lot or each reagent cartridge based on a system configuration parameter and the Reagent
Selection options (module, auto, select cartridge) that are chosen for the order.
· If quality control is run for each reagent cartridge and any control level fails, the individual reagent
cartridge is disabled.
· If quality control is run for each reagent lot and a tested control level fails, all reagent cartridges for
that lot are disabled, including any cartridges that are subsequently loaded on the system.
The system automatically enables the reagent cartridge or the reagent lot after the failed QC result is
rerun and the result is within acceptable limits.
When a control fails, a CNTL flag will be assigned to all subsequent 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) result is rerun for the same control name and control level and
the result is within acceptable limits. When out-of-range QC results are deleted, the CNTL flag is not
removed from specimen results.

Control Orders
The three items that help make sure quality results and optimal system performance are achieved are:
1. Carefully follow all directions in the Operations Manual (Help) and the reagent manufacturer’s
assay documentation.
2. Never use expired or contaminated consumables.
3. Perform maintenance procedures and calibration procedures as recommended.
Control Orders
Order requests for specimens, calibrator samples, and quality control samples can be created
automatically or manually by an operator.
General Control Ordering Rules

· 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.
· Controls not loaded in a vial rack and designated as STAT must be priority loaded to be processed as
STAT controls.
· The list of available assays can be filtered. Tap the option for i-series, c-series, or Calculated.
· 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 does not exceed
220.

Control Orders
Automated Control Ordering

Automated control ordering is available by configuring the system parameters of the Alinity ci-series.
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.
¥ For Automated Control Ordering Procedures refer to the Alinity ci-

series Operations Manual Section 5 Specimen Cal and Control Orders,
subsection; Specimen, calibration and control orders, Automated
ordering, Automated control ordering.

Control Orders
Manual Control Ordering

Orders Screen
The Orders screen can be access by tapping the Orders icon on the Menu Bar.
On the Orders screen, the operator can view specimen, control, calibration, and rerun orders. The
operator can create a new control order, add a comment to an order and delete orders.
For control order status information select the Control tab.
The Details Function button navigates to the Details screen for the selected items on the current
screen. On the Order Details screen, the operator can view the details for the control test order.

Control Orders
Create a Manual Order

The Create Order Function button navigates to the Create Order screen. On the Create Order
screen, the operator can manually create a Quality Control (QC) Order.
To create a QC Order on the Create Order screen, begin by tapping the Control tab. Then enter the
required information as directed in the Operations Manual.
Create Control Order
· ORDERS Icon
· CREATE ORDER
OR
¥ NOTE: The Create Order icon is a configurable icon on the menu bar.

Control Orders
From Create Orders Screen

· Select CONTROL Tab
4 Optional when bar- coded samples used
· Select Control Data:
4 Control Name
4 Control Lot
4 Control Level
4 Assays/ Panels
4 ASSAY OPTIONS -optional:
§ Assay
§ Dilutions/ # Replicates
§ DONE
· Select:
4 ADD ORDER
The system automatically defaults to the next level of that control product.
¥ For the Procedure to create a control order refer to the Alinity ci-series
Operations Manual Section 5 Operating Instructions subsection:
Specimen, calibration, and control orders>Orders Screen>Create Order
screen.
following location:
-Sample processing>Order tests>Control orders>Create a control order

Control Orders
Prepare and load vials for onboard storage

For instructions for calibrator or control handling and use, see the assay documentation.
Verify that the controls are within the expiration dates on the vial labels. Do not use controls that are
expired.
Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before performing sample
processing. Use a new applicator stick for each vial to prevent cross contamination.
Place each opened vial in the yellow vial rack with standoffs so that the vial bar code is visible in the
rack window and the bar code fills the width of the window.

2. Tap Run
Processing status.
illuminates.
¥ NOTE: Onboard vial racks are processed as priority racks regardless of

the position of the rack on the loading area of the RSM.
RSM.

Control Orders
When the control vial is scanned by the RSM bar code reader,
· The Alinity ci-series tracks and maintains a record of the control lot number, vial serial number and
expiration date.
· Onboard stability tracking occurs. In-use stability tracking occurs when the calibrator is not in
refrigerated storage while on the system.
4 To ensure correct tracking status, do not move the vials to a processing module that is controlled
by a different system control module.
· The vial is assigned to the onboard vial rack and should not be removed until the control vial is
empty or expired
¥ To Prepare and load vial racks for onboard storage, refer to the
Alinity ci-series Operations Manual Section 5 Operating Instructions
subsection: Reagent and sample management, reagent carousel inventory
management, reagents screen, Prepare and load vials into vial racks for
onboard storage
following location:

empty the waste>Reagent carousel inventory>Prepare and load vials into
vial racks for onboard storage.
ĐƟǀ ŝƚǇϭ
Prepare and load vials into vial racks for onboard use
1. Load control vials into vial racks for onboard use. Your facilitator will identify controls to load

Control Orders
ĐƟǀ ŝƚǇϮ
Create control order(s) for controls stored onboard the system
1. Locate the procedure(s) needed to create a manual control order, in the online Operations Manual
or other available reference material.
2. Create a control order(s) for assay(s) that have controls stored onboard the system.
4 as applicable, run controls on assay(s) calibrated in prior module, or your facilitator will identify
assay(s)
ĐƟǀ ŝƚǇϯ
Create control order(s)
1. Create control order(s) for assay(s) that do not have controls stored onboard the system.
4 as applicable, run controls on assay(s) calibrated in prior module, or your facilitator will identify
assay(s).

Control Orders
ĐƟǀ ŝƚǇϰ
Load controls into sample racks
1. Create a control order for a control not in an Abbott vial.
2. Load the control sample into sample racks.
4. Initiate or resume sample processing.
ĐƟǀ ŝƚǇϰ
Unload vials from the reagent and sample manager (RSM)
1. After the controls(s) are complete, unload vials from the reagent and sample manager (RSM).
4 Confirm status indicator status before unloading.
2. Return the vials to storage.

Control Orders
Review QC Results
Once QC sample processing completes, the operator can review results and flags to determine if QC is
in range or needs to be rerun.
The system evaluates quality control (QC) results by assay for each control lot.
Quality control issues must be evaluated and resolved before specimens are tested.
Results Screen
From the Results screen the operator can view:
· Specimen and control results

· Specimen and control exceptions
The Results screen can be accessed by tapping the Results menu icon or on the Home screen,
tapping the Result button next to Pending Results.
The following functions can be performed from the Results screen:
· Find information about a specific test based on specified search criteria.

· Access result information.
· Release or delete a result.
· Rerun a test

Control Orders
Result information can be filtered by selecting a tab:
· Unreleased tab
¥ Note: If system is configured to automatically release specimen and QC

results, there will not be an unreleased tab
· Specimen tab
· Control tab
· Exception tab
The Exception tab of the Results screen can be directly accessed by tapping the Exceptions button on
the Home screen.

Control Orders
Results Details Screen

The Result Details screen displays the result details for specimens and controls.
The Details Function button navigates to the Results Details screen for the selected items on the
current screen.
On the Result Details screen, the operator can view the following information:
· Details for specimen results, control results, or exceptions.

· Reaction graphs only for c-series.
The operator can add a comment to a result or an exception.
Using the Rerun Options flyout, the operator can order a rerun on a control test. The rerun tests that
are scheduled can be viewed on the Sample Status screen or the Orders screen.

Control Orders
QC Result Flags
When a QC result has a flag, the information is displayed in red text on the Results screen. Result flag
information is used to provide additional information about a result and to indicate that the result
may need to be reviewed. One or more result flags are displayed if they are applicable to a QC result.
¥ For a description of QC result flags refer to the Alinity ci-series

Operations Manual Section 5 Operating instructions subsection: Results
screen>Descriptions of quality control result flags.
Release QC Results
QC Results can be manually released from the Results screen.
To release results,
· In the list, tap one or more tests to release (or tap Select All).
· Tap Release
¥ NOTE: If system is configured to automatically release QC results, they

will not show up on the unreleased tab and will automatically go to the
control tab when complete.

Control Orders
Archive QC Results
The Alinity ci-series has a procedure to archive controls, calibrations and 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.
The archiving procedure for released samples or controls is performed from the Results screen
· Begin by tapping the appropriate tab.

· Select one or more results
· Tap the Archive function button to display the Archive flyout.
The Archive Options and Modes are the same as those previously presented in the Calibration
Training Module
¥ To perform actions from the Results screen refer to the Alinity ci-series
Operations Manual Section 5 Operating Instructions subsection; Results
Screen
-Sample processing>Results management>Delete a sample result or

exception
-Sample processing>Result management>Rerun a test or an exception for

a specimen or control
-Sample processing>Result management>Add a comment to a result or

an exception
-Sample processing>Result management>Release a specimen result or a

control result
-Sample processing>Archive>Archive the results

Control Orders
ĐƟǀ ŝƚǇϱ
View QC results in the Results screen
1. View the QC results previously generated in the Results screen.
ĐƟǀ ŝƚǇϲ
ĞƐĐƌŝƉƟŽŶƐŽĨƚŚĞY ƌĞƐƵůƚĨĂŐƐ
1. Identify the QC result flags produced.
2. If no flags were produced, review the Operations Manual (Help) and list the control flags.
ĐƟǀ ŝƚǇϳ
ĞůĞƚĞĂY ƌĞƐƵůƚŽƌĂŶĞǆĐĞƉƟŽŶ
1. Find a QC result in the Results screen and delete the result.
ĐƟǀ ŝƚǇϴ
ZĞƌƵŶĂƚĞƐƚŽƌĂŶĞǆĐĞƉƟŽŶĨŽƌĂĐŽŶƚƌŽů
1. If an exception was generated, find the exception and rerun.
2. If an exception was not generated, rerun any QC.
ĐƟǀ ŝƚǇϵ
ĚĚĂĐŽŵŵĞŶƚƚŽĂY ƌĞƐƵůƚŽƌĂŶĞǆĐĞƉƟŽŶĨƌŽŵƚŚĞZĞƐƵůƚƐ
screen
1. From the Results screen, add a comment to a QC result or an exception.

Control Orders
ĐƟǀ ŝƚǇϭϬ
Release a QC result from the Results screen
1. From the Results screen or the Sample Status screen, release all QC specimen results.
ĐƟǀ ŝƚǇϭϭ
Archive QC results
1. Archive all QC results generated during the previous activity

Control Orders
Review
1. The yellow onboard vial rack with standoffs should be used to load vials for onboard storage.
a. True
b. False
2. Select all of the following guidelines to help ensure quality results and maintain optimal system
performance. (Select all that apply)
a. Perform maintenance procedures and calibration procedures as recommended
b. QC issues do not have to be evaluated and resolved before specimens are tested
c. Carefully follow all directions in the operations manual and the reagent manufacturer’s assay
documentation
d. Do not use expired or contaminated consumables

Control Orders
3. Which of the following procedures do you perform to create a control order?
a. Tap the correct number of replicates for each dilution if the default number of replicates for one or
more dilutions is correct.
b. Load controls that are designated as STAT to be processed as STAT controls at a later time
c. On the menu bar, tap Orders
d. For bar-coded samples, write down the rack ID and the position number
4. A USB flash drive is necessary in order to archive results.
a. True
b. False

8 WĂƟĞŶƚ^ĂŵƉůĞK ƌĚĞƌƐ
ϭ͘ ϱŚŽƵƌƐ
Module Topics
Sample processing includes procedures used to prepare samples, initiate processing, unload samples,
and manage results.
· Preparing for operation

· How to order specimen tests
· Sample management
· Results management

Patient Sample Orders
K ďũĞĐƟǀ ĞƐ
o Create a single specimen order and a bar-coded batch specimen

order
o Print the Order List Report
o View patient order and sample status details
o Identify the sample bar code requirements, requirements for

handling specimens and sample specifications and requirements
o Initiate or resume sample processing
o Load and unload samples from the reagent and sample manager
(RSM)
o Explain Sample interference indices principles (c-series)
o Review and release patient results and rerun exceptions
o Explain result flags
o Add a comment to a patient result
o Add dilution/replicates to an order
o Archive patient results

are:

control orders and Results screen
Section 4 Performance characteristics and specifications subsection;

Specifications and requirements

WĂƟĞŶƚ^ĂŵƉůĞK ƌĚĞƌƐ
Patient sample orders is the task you will perform most often on the Alinity ci-series even if it is an
automated process using a connected LIS. You should be familiar with the process for manually
ordering patient sample runs as a backup method.
There are several different combinations of patient order types:
· Single (one patient sample)

· Batch (same test run on multiple samples)
4 Bar coded
· Routine vs. priority (STAT) processing on RSM
You will use the Order screen to run all types of patient sample orders.
Automated Sample Ordering

Order requests for specimens, controls, and calibrations can be created automatically.
Automated specimen ordering is available by using host computer downloads, host order queries, or
the retest option of the Alinity ci-series.

Manual Ordering
The Create Order icon on the menu bar is a configurable icon and is an alternate way to navigate to
the Create Order screen.
OR, from the Orders screen use the Create Order Function button to navigate to the Create
Order screen.
From the Orders screen, the operator can view specimen, control, calibration, and rerun orders. The
operator can create a new specimen order, add a comment to an order, order a dilution, add replicates
and delete orders.

Create a single specimen order
From the Specimen tab on the Create Order screen, the operator can create a single specimen
order when the Single Specimen option in the Order Type area is selected.
The Single Specimen option orders one or more tests as a single sample. It is the default.
Enter the required information as directed in the Operations Manual. If bar-coded samples are used
the rack ID and position number are not required.

D ĂŶƵĂů ŝůƵƟŽŶƐ
Not all assays support manual dilutions. Assays that do not support manual dilution are displayed as
unavailable when a manual dilution is selected.
¥ For dilution information, see the assay documentation.
Bar-coded batch specimen
From the Specimen tab on the Create Order screen, the operator can create a bar-coded batch
order when the Bar-Coded Batch option in the Order Type area is selected.
The Bar-Coded Batch option orders the same tests for multiple bar-coded specimens.
· When running bar-coded batch do not load calibrators, do not leave empty spaces in the sample
rack and 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.
In the Sample Data area, enter or scan the starting and ending sample IDs (SIDs) for the batch.

ƐƐĂǇK ƉƟŽŶƐ
The Assay Options flyout is used to define the number of replicates and Dilution Protocol.
Replicates
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 does not exceed 220.
Dilutions
Not all assays support automatic dilutions.
For dilution information, see the assay documentation.
Add / Delete a Test from Sample Order
Adding a test to the order is the same as creating a new order using the same SID.
To delete a test, the test status must be Pending or In Process. One or more tests can be deleted from
the Orders Screen by tapping Delete and responding OK to the confirmation message.
Comments
In the Comments box, additional information that is associated with the sample can be entered by the
operator. Comments are displayed and are printed with each test that is ordered for the sample.

Order List Report
The Order List Report lists the minimum sample volume information for each sample. The sample
volume information should be utilized to verify adequate volume is present in sample cups and tubes
for testing.
From the Orders screen select the All Orders tab. Select the function button Print to display the
Print Flyout.

Create Specimen Orders Print/View Orders

From HOME Screen Select: From ORDERS Screen Select:
· ORDERS Icon · All Orders Tab

· CREATE ORDER To View Report:
OR
· Select PRINT
Select CREATE ORDERS Icon if present · Select ORDER LIST REPORT

· DONE
¤ NOTE: The Create Order icon is a
configurable icon on the menu bar.
To Print Report
· Select PRINT
· Select ORDER LIST REPORT
· Select SPECIMEN Tab · Select Print Location
· Order Type: · Type # copies
4 Default Single Specimen · PRINT
4 Bar-coded Batch
· At Sample Data Type:
4 SID (Sample ID)
4 Rack and Position
§ Optional with barcoded samples
· Select Assays/Panels
· Comments -optional
· Patient Details-optional
· Assay Options edit optional:
4 Dilutions Protocol
4 # Replicates
4 DONE
· Select:
4 ADD ORDER
Load Specimens in RSM Racks

¥ For procedures related to specimen Order Requests refer to the Alinity

Specimen, calibration, and control order>Orders Screen
following location:
-Sample processing>Order tests>Specimen orders>create a single

specimen order
-Sample processing>Order tests>Specimen orders>Create a bar-coded

batch specimen order
-Sample processing>Order tests>Specimen orders>Add a test to a

specimen order
-Sample processing>Order tests>Specimen orders>Delete a test from a

sample order
-Sample processing>Order tests>Specimen orders>Add a comment to an

order

WƌŽĐĞƐƐŝŶŐWĂƟĞŶƚ^ĂŵƉůĞK ƌĚĞƌƐ
WƌĞƉĂƌĞĨŽƌK ƉĞƌĂƟŽŶ
Preparing the Alinity ci-series before processing specimens will help you maximize the workflow in
your laboratory. This includes performing the following:
· Verify the reagent inventory.

· Verify the consumable inventory.
· Verify the waste container status, if applicable.
· Perform daily maintenance.
· Determine calibration status
¥ To Prepare for Operation refer to the Alinity ci-series Operations Manual

Section 5 Operating Instructions
¥ To locate the procedures using the online Procedure Map refer to the

empty the waste>Reagent carousel inventory>Verify the reagent carousel
inventory

empty the waste>Consumable inventory management>Verify the supply
and waste inventory
-Sample processing>Prepare for operation>Perform Daily maintenance
-Perform a maintenance procedure or a diagnostic procedure
-Use a procedure key to perform a procedure
-Sample processing>Prepare for operation>View the assay calibration

status>View the assay calibration status
Prepare and load racks
Before loading samples into the sample rack, become familiar with sample bar code label
requirements and sample specifications and requirements
¥ Note: For Sample racks with bar code IDs that begin with letters A
through C, 16mm tubes cannot be used.

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
Aliquot tubes, primary tubes, or sample cups that contain samples (specimens, calibrators, or
controls) can be loaded into sample racks.
Use the sample gauge to verify sample volume in an aliquot tube is adequate.
1. Load aliquot tube into sample rack so sample volume is visible in sample rack window.
2. Verify the amount of sample in the aliquot tube exceeds the 88mm sample gauge line.
¥ IMPORTANT: Do not use the sample gauge to verify aliquot tube volumes
for c-series whole blood applications.
For primary tubes, the minimum sample volume must not be less than 8mm above the separation
point (clot, gel separator, or plasma or red cell interface) to prevent contamination of the sample
during aspiration.

Ensure the sample bar code label is correctly affixed to sample tube.
¥ Refer to the Operations Manual for recommended bar code label

guidelines.
Use the sample cup volume graduation marks to verify that the sample volume present in a sample
cup is adequate as listed on the Order list report.
To ensure accurate liquid level detection, do not fill sample cups above the 1400 ul graduation mark.
The Alinity ci-series requires a minimum of 150 ul for routine testing of controls and specimens. This
recommendation supports onboard sample storage for 3 hours under average laboratory conditions
without observable concentration effects because of sample evaporation.
The reliability of assay results cannot be guaranteed if an adequate sample volume is not used.
Sample volume requirements depend on the sample vessel type, the onboard sample storage
conditions, and the ordered assays.
Ensure sample volume is adequate so that retesting can be performed if the samples are loaded
on the reagent and sample manager (RSM) and the RSM is configured to reposition the samples
automatically for retesting.

Load the sample into the sample rack so that a sample bar code, if used, is visible in the sample rack
window and the bar code fills the width of the window.
Avoid splashing the sample outside the sample cups or tubes.
¥ IMPORTANT: If loading sample cups or tubes, ensure that they are

pushed down completely in the sample rack and they are not tilted.
If loading non-bar-coded samples, print the Order List Report to ensure that each sample is loaded in
the correct rack and position.

2. Tap Run.
Processing status.
illuminates.
RSM. When loading racks onto a tray, ensure the rack is flush against the back of the tray.
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.

Before unloading samples confirm that the status indicator is illuminated and blinking green, a steady
green, or alternating green and amber on the reagent and sample manager (RSM)
¥ To load patient samples, refer to the Alinity ci-series Operations Manual

Section 5 Operating Instructions subsection; Reagent and sample
management
¥ To locate the procedure using the online Procedure Map to refer to the
following location:
-Sample processing>Load samples
Order Status
The Alinity ci-series system shows various statuses and codes for both the entire order, as well as
individual samples.
Test Statuses
Test status information is used to determine the progress of an ordered test or to manage specimen
and control results.
The system tracks the test statuses for each ordered or completed test.
Test Status Description

Pending The test is ordered, but the RSM bar code reader has not scanned the
corresponding sample
Scheduled The test is ordered and the sample is scanned by the RSM bar code
reader, but the instrument has not aspirated the sample.
Running The test is ordered, the sample is scanned, and the instrument is
processing the sample.
In Process For a calculated test, the tests that are necessary to calculate the test
result are in process.
For a batch order, the sample labeled with the starting SID of the batch
order was scanned by the RSM bar code reader, and the batch order is in
process.
Exception The test order failed and a test result was not generated.
Complete The test is completed.

Processing Codes
Processing code information is used to determine how samples are processed.
One or more processing codes are displayed if the codes are applicable to an ordered test or test
results.
Processing Code Description

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.
B The test is part of a batch order.
C The test has a comment.

ĐƟǀ ŝƚǇϭ
Create a single specimen order
1. Locate the procedure(s) needed to create a single specimen order, in the online Operations Manual.
2. Order patient samples using data in table below or samples that have been provided to you by your
instructor based on assays loaded on your instrument.
SID Assays/ Panels Patient Details Assay Options

002 Chem6, BhCG, AST Tara Bug, Female 2 replicates of AST
PID 12345
DOB 8/30/2000
004 TP, Trig, BhCG June Bug
Lipemic
006 Fertility panel, Chem6, Ada Bug GluC 1:5 dilution

HIL Panel
008 HIV, AlbP, Trig, GluC Jed R. Bug
Icteric
010 B-hCG, TSH, GluC, Trig L. M. Jake 2 replicates of Trig
DOB 3/27/2002
012 GluC, CreaC, BhCG Betty Bug Manual 1:2 dilution for
GluC only
Review the results of the sample test and, if your facilitator instructs you to, release the results, then
view on the Stored Results screen.

ĐƟǀ ŝƚǇϮ
Add a test to a specimen order
1. Add a test to one of the specimen orders created in Activity 1.
4 Your facilitator will define what assay to use
ĐƟǀ ŝƚǇϯ
Delete a test from a specimen order
1. Delete a test to one of the specimen orders created in Activity 1.
ĐƟǀ ŝƚǇϰ
Create a bar-coded batch specimen order
1. Locate the procedure(s) needed to create a bar- coded batch specimen order, in the online
Operations Manual.
2. Then create a bar-coded batch specimen order . Your facilitator will define what assays to use
ĐƟǀ ŝƚǇϱ
Print the list of orders
1. Locate the procedure(s) needed to Print Order in the online Operations Manual.
2. Create an Order List Report.
3. Load Racks and place onto RSM.
4. Initiate or Resume Processing.

Sample Status
Access the Sample Status screen by tapping the Sample Status menu icon on the Home screen, or
tap the Sample Status button next to Total samples.
On the Sample Status screen, the operator can view the following information:
· Specimen orders, control orders, and calibration orders

· Unreleased results for specimens and controls
· Tests that are scheduled for reruns
· Test exceptions that have not been rerun, released, or deleted

· Access test information.
· Add a comment to a test order.
· Transmit a result.

· Suspend the processing of a sample.

· Rerun a test.
· Print a sample status report.
Sample status information can be filtered by selecting the desired tab:
· All Samples tab

· Specimen tab
· Control tab
· Calibrator tab
The Release function button is used to Release the selected test results or exceptions.
· Test results remain on the Sample Status screen until all results for the specimen or control are
released.
· Test exceptions that have not been rerun or released for transmission remain on the screen.
· Rerun or released test exceptions remain on the Sample Status screen until all results are
transmitted.
The Status/Result section displays the current status (Pending, Scheduled, Running, In Process,
Exceptions, or Complete) of specimen orders, control orders, and calibration orders or displays
specimen results and control results
The sample status colors are as follows:
· 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 has an exception or has a flag.

Results and Reruns

The Results screen can be accessed by tapping the Results menu icon, or on the Home screen,
tapping the Result button next to Pending Results.
You can access the Exception tab of the Results screen by tapping the Exceptions button on the Home
screen.
The following functions can be performed from the Results screen:

· Access result information.
· Release or delete a result.
· Rerun a test
Test results can be found from the Sample Status screen or the Results screen.

Result information can be filtered by selecting a tab:
· Unreleased tab
· Specimen tab
· Control tab
· Exception tab
Result Details, Comments and Reruns

The Details Function button navigates to the Result Details screen for the selected items on the
current screen.
On the Result Details screen, the operator can view the following information:
· Details for specimen results, control results, or exceptions

· Reaction graphs (only for c-series)
The operator can add a comment to a result or an exception. Comments are displayed and printed
with the result or exception. In addition, comments for samples and tests are displayed if comments
were entered.
Using the Rerun Options flyout, the operator can order a rerun test. Rerun request can be made from
either the Sample Status screen or the Results screen
Review ReRuns
Where do Results for Reruns Show Up?

Result Flags
Flags provide additional information about a result and indicate that you may need to review the
result. All results with flags display in red.
Flag Description
EXP* The result was measured using an expired reagent, supply or onboard
solution.
EXPC* The result was calculated using an expired calibration curve or expired
calibrators.
A#1* A#2* The result was calculated by using the only reading (or only two readings
(c-series) for A2#), of all the readings in the main or flex reading window, that has
measured absorbance within the defined absorbance range.
The result was calculated by using the only reading (or only two readings
for A2#), of all the readings in the main or flex reading window, that has
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high or the
sample is lipemic.
CNTL* The result was calculated after the quality control failed.
The flag is displayed on subsequent results until the failed quality control
(QC) result is rerun for the same control name and control level and the
result is within acceptable limits. When the control material cannot be
repeated to obtain an acceptable value, the procedure to clear a control
failure must be performed.
¤ NOTE: Only Westgard rules that are configured as a failure

produce a CNTL flag for a patient result.
<or> The result is outside the dynamic range or linear range.
¤ NOTE: For c-series assays, the displayed value is the result

of an adjustment by the sample dilution factor. Additionally,
the displayed > value reflects an adjustment by the entered
correlation factor and intercept for assays that use nonlinear
calibration methods when the sample absorbance exceeds the
highest calibrator absorbance.
FLEX* (c-series) Result was calculated using read data measured during the flex read
time.
PSHH* (c-series Result may be affected by ICT sample measured immediately prior. The
ICT assays) sample must be rerun to verify that no affects have occurred.

Flag Description
LL or HH The result is outside the defined extreme range.
NOTE: The result is rounded to the reporting number of decimals for an

assay and then is compared against the range.
LOW or HIGH The result is outside the defined normal range.
¤ NOTE: The result is rounded to the reporting number of

decimals for an assay and then is compared against the range.
CORR* The result was produced by using a correlation version of the assay
*These flags are carried over from a constituent assay result to a calculated assay result.
Transmission Status
Transmission status information is used to determine the progress of a result transmission to the
host. The transmission status is displayed on the Result Details flyout.

Manually Transmit a Result to Host

To transmit released specimens, released controls, or exceptions:
4 Tap the appropriate on the Results screen.

4 In the list on the tab, tap one or more results or exceptions (or tap Select All).
4 Tap Transmit
Delete a Result
To delete released specimens, released controls, or exceptions, tap the appropriate tab on the Results
screen.
4 In the list on the tab, tap one or more results or exceptions (or tap Select All).
4 Tap Delete.
4 When a confirmation message is displayed, tap Yes.

Sample Interference Indices

Sample interference Indices measurement is the process a c-series instrument uses to measure
hemolysis, icterus, and lipemia in a sample once it has been mixed with saline. These estimates are
also known as indices.
The estimation is based on the absorbance measure of:
· Turbidity for lipids (lipemia)

· Red color for hemoglobin (hemolysis)
· Yellow color for bilirubin (icterus)
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
Indices Measurement Principles

To measure the three interfering substances, the system measures absorbance values of four
wavelength pairs and, using the appropriate photometric reads, applies a mathematical calculation to
determine the relative interferent concentration in serum/plasma specimens.
¥ NOTE: For more information on wavelength pairs and the mathematical

calculation refer to the Alinity ci-series Operations Manual-Section 3
principles of operation

Ordering Sample Interference Indices
To order Sample Interference Indices select H, I, and L assays. You may order one or more of the
indices. You do not need to order the HILref assay. The system uses this assay file to calculate results.
If you order only the HILref assay, you will not get any H, I, or L results.
ǆĐĞƉƟŽŶƐ
An exception occurs when a test fails to complete.
The Exception tab on the Results screen displays rerun and unreleased test exceptions and test
exceptions that have been released manually or automatically for transmission.
A test exception remains on the Exception tab until the exception is deleted by an operator or is
deleted automatically after 24 hours based on the completion time of the exception.
Exceptions use the same patient result flags as original orders and rerun tests.
ǆĐĞƉƟŽŶ^ƚĂƚƵƐ
There are three Exception statuses:
· Blank - Exceptions have not been rerun or released.

· Rerun - Exceptions have been rerun, but they have not been released.
· Released - Exceptions have been released manually or automatically for transmission to a host
computer.
The Message Code displays the numeric message code for the exception and the message text that
describes the error.

Use the available function buttons to print, access details, rerun, release, transmit or delete selected
items.
Any order can go to exceptions, but you can only rerun control and patient exceptions. Calibrator
exceptions must be deleted and reordered.
Stored Results
Once patient results are released, they are moved to the Specimen tab on the Results screen.
As with other screens the operator can search for, access details, transmit, delete, print, and/or
archive a released result.
ƌĐŚŝǀ ĞZĞůĞĂƐĞĚWĂƟĞŶƚZĞƐƵůƚƐ
As previously presented in the Calibration and Control Training Modules. The Alinity ci-series has a
procedure to archive controls, calibrations and specimen results to a USB flash drive.
The archiving procedure for released samples or controls is performed from the Results screen by
accessing the Archive flyout.
ĐƟǀ ŝƚǇϲ
Sample Status Screen
1. Access the Sample Status Screen, and view the results previously generated.
2. Take note of the sample status colors and their meaning.
3. Add a comment to a result or an exception.
4. Release a specimen result.

ĐƟǀ ŝƚǇϳ
Results screen
1. Access the Results Screen.
2. View the results previously generated.
3. Take note of any specimen result flags generated by the system.
4. Find a result in the Result Status screen and delete the result.
5. Add a comment to a result or an exception.
6. Release a specimen result.
ĐƟǀ ŝƚǇϴ
Rerun a specimen test
1. From the Results Screen:
· 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.
ĐƟǀ ŝƚǇϵ
Archiving
1. Archive results as directed by your facilitator

Review
1. Select all of the following tasks you should perform when preparing for operation. (Select all that
apply)
a. Perform daily maintenance
b. Load samples into sample racks
c. Check the inventory
d. Replenish the inventory and empty the waste
2. Identify the Test Status that matches the description below:
The test has been ordered and the sample has been scanned by the RSM bar code reader, but
instrument has not aspirated the sample.
a. Scheduled
b. Pending
c. In Process
d. Exception
e. Running
3. View the assay calibration status before sample processing is initiated or when a calibration status
indicator is displayed.
a. True
b. False

4. Identify the Processing Code that matches the description below.
The test is an original result for a rerun.
a. R
b. *
c. D
d. M
e. B
5. You can release a specimen result or a control result from either the Sample Status screen or the
Results screen.
a. True
b. False
6. Select all the correct sample barcode guidelines. (Refer to the Operations Manual to answer this
question)(Select all that apply)
a. Use labels with an American National Standards Institute (ANSI) grade of A, B, or C
b. Printer must have a minimum resolution of 300 dots per inch (DPI)
c. The symbology Code 39 can be used on the Alinity ci-series
d. 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.

7. To delete a sample result or an exception, begin by clicking ORDERS on the menu bar.
a. True
b. False
8. From which of the following screens can you add a comment to an order? (Select all that apply)
a. Orders
b. Sample Status
c. Results
d. Exceptions
9. Select all of the following dependencies for sample volume requirements: (Select all that apply)
a. Pipettor
b. Sample vessel type
c. Onboard sample storage conditions
d. The ordered assays.

10. On the Sample Status screen, the operator can view unreleased calibration and control results.
a. True
b. False
11. For i-series assays, no more that 10 tests for each sample that is loaded in sample cups should be
ordered.
a. True
b. False
Answer: a
12. For c-series ICT assays, no more than 15 tests for each sample that is loaded in sample cups or
tubes should be ordered.
a. True
b. False

9 Basic Sample Progression
ϰϱŵŝŶƵƚĞƐ
Module Topics
An Alinity ci-series System uses various detection technologies to measure analyte concentrations in
samples.
· Principles of operation (c-series)

· Principles of operation (i-series)
K ďũĞĐƟǀ ĞƐ
o Describe the basics of the Photometric method (c-series)
o Describe the basics of the Potentiometric method (c-series)
o Describe Assay processing (c-series and i-series)
o Explain the SmartWash feature (c-series photometric)
o Describe the basics of chemiluminescent microparticle

immunoassay (CMIA) detection technology

are:
Section 3 Principles of operation

Basic Sample Progression
c-series Measurement Methods

Photometric technology
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

· Rate assay reactions
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.

WŽƚĞŶƟŽŵĞƚƌŝĐƚĞĐŚŶŽůŽŐǇ
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-).
Data reduction calculation is used to calculate the final result concentration.
· ICT Reference Solution (once before and after each serum sample and twice before and after each
urine sample) to provide a reference potential that is used to calculate results.
· Samples (patient, quality control, and calibrator) to obtain readings that are used to calculate
results.
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.

c-series Assay Processing

The following are the assay protocols or assay-processing methods on the instrument.
· Assay processing for a one-reagent protocol (c-series).

· Assay processing for a two-reagent protocol (c-series).
· Assay processing for a dilution protocol (c-series).
· Assay processing for a pretreatment protocol (c-series).
· Assay processing for an ICT protocol (c-series).
Many kinds of assay-processing activities occur between sample aspiration and final result reporting.
Components that are located around the reaction carousel perform these activities.
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.

Sample Progression Basics

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.
Activities occur at specified times and locations. The maximum reaction time is 10 minutes.
Basic Processing Activities

The sample pipettor dispenses sample into the cuvette.
Reagent 1 pipettor dispenses reagent in the cuvette.
Mixer 1 mixes the sample and reagent.
The photometer measures the absorbance.
The reaction mixture incubates while the photometer takes absorbance readings each time that
the cuvette passes the photometric position. A total of 38 readings.
The cuvette washer aspirates the reaction mixture to waste, cleans and dries the cuvette:
· The cuvette is cleaned with Alkaline Wash, Acid Wash, and purified water.
· Then, the cuvette washer dispenses purified water into the cuvette for the water blank
· Measurement, which ensures cuvette integrity.
· Finally, the cuvette washer aspirates the water and dries the cuvette.
Some assay protocols also use the following activities:
If onboard dilution is required, the sample pipettor aspirates the diluted sample and dispenses
the sample into the new cuvette that is located at position 1.
If a second reagent is required for the reaction, reagent 2 pipettor dispenses the second
reagent, then the mixer 2 mixes the second reagent with the sample and reagent mixture.
For an ICT sample, the ICT probe aspirates the diluted sample into the ICT unit.
Assay Processing Videos

For more information regarding the assay-processing steps that occur for specific assay protocols or
assay-processing methods watch the following videos in the operations manual and review the steps
of each.

Assay processing for a one-reagent protocol
1. At position 1, the sample pipettor aspirates sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates reagent and then dispenses the reagent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the reagent.
4. At positions 4 through 153, the reaction mixture incubates, and the photometer measures the
absorbance each time that the cuvette passes the photometric position.
5. At positions 154 through 182, the cuvette washer aspirates the reaction mixer to waste and cleans
the cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette washer dispenses
purified water into the cuvette for the water blank measurement, which ensures cuvette integrity.
Finally, the cuvette washer aspirates the water and dries the cuvette.
Assay processing for a two-reagent protocol
cuvette.
5. At position 75, the reagent 2 pipettor aspirates the reagent and then dispenses the second reagent
into the cuvette.
6. At position 76, mixer 2 mixes the second reagent with the sample and reagent mixture.
8. At positions 154 through 182, the cuvette washer aspirates the reaction mixer to waste and cleans
Finally, the cuvette washer aspirates the water and dries the cuvette.

ƐƐĂǇƉƌŽĐĞƐƐŝŶŐĨŽƌĂĚŝůƵƟŽŶƉƌŽƚŽĐŽů
cuvette.
4. At position 5, the sample pipettor aspirates the diluted sample and then dispenses the diluted
sample into a new cuvette. Then, the system processes the diluted sample according to the one-
reagent or two-reagent protocol as appropriate.
Assay processing for a pretreatment protocol
cuvette.
4. At position 5, the sample pipettor aspirates the pretreated sample and then dispenses the
pretreated sample into a new cuvette. Then, the system processes the pretreated sample according to
the one-reagent or two-reagent protocol as appropriate.

Indirect Assay Processing

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.
· Information from the General tab of the Assay Parameters screen can be used to determine if an
assay is a primary or a secondary assay.
SmartWash feature
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.

c-series ICT Processing

ICT Reference Solution and ICT samples are delivered to the ICT module where measurements occur.
¥ For videos associated withe the processes below, see the Alinity ci-series
Operations manual Section 3 Principles of Operation>Principles of
Operation (c-series)>Potentiometric method (c-series)>ICT measurement>
ICT Reference Solution Sample Delivery and Processing.
During processing, the following events occur:
ICT Reference Solution Delivery
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 ICT reference solution cup is filled with ICT Reference Solution
1. 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.
2. The ICT unit moves down to position the ICT probe in the ICT Reference Solution cup.
The ICT Reference Solution is analyzed.
3. The syringe on the right side of the ICT aspiration pump
4. 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.
Waste is Removed.
High-concentration waste processing begins:
5. 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.
6. The syringe on the left side of the ICT aspiration pump moves the liquid waste from the high-
concentration waste compartment.
7. 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:
8. The syringe on the right side of the ICT Reference Solution pump moves the remaining ICT
Reference Solution from the ICT Reference Solution cup.
9. 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.
10. 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 and Processing
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 and reagent are dispensed into the cuvette
1. The sample pipettor dispenses 15 µL of sample into a cuvette.
2. Reagent pipettor 1 dispenses 69 µL of ICT Sample Diluent (ICTD5) and 276 µL of water into the
cuvette.
3. Mixer 1 mixes the sample, the diluent, and the water.
4. The reaction carousel continues to rotate until the cuvette aligns with the ICT unit. The cuvette
alignment occurs after 37 reaction carousel movements.
The sample is analyzed.
5. The ICT unit moves out and down to position the ICT probe in the cuvette.
6. The syringe on the right side of the ICT aspiration pump aspirates the sample from the cuvette into
the ICT module.
7. The ICT module measures the sample. The system converts the measurements into millivolt
readings that are used to calculate sample result concentrations.
Waste is removed.
1. The syringe on the right side of the ICT aspiration pump moves the sample from the ICT module to
the high-concentration waste compartment.
2. The syringe on the left side of the ICT aspiration pump aspirates the liquid waste from the high-
concentration waste compartment.

3. 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..
ICT Assay Processing Video

For more information regarding the steps that occur during ICT assay-processing watch the video as
directed by instructor.
Assay processing for ICT protocol
2. At position 2, the reagent 1 pipettor aspirates ICT sample diluent and then dispenses the ICT
sample diluent into the cuvette.
3. At position 3, mixer 1 mixes the sample and the ICT sample diluent.
4. At position 40, the ICT probe aspirates the diluted sample, and then the ICT module analyzes the
diluted sample.
¥ Note: The ICT module analyzes the ICT Reference Solution once before
and after each serum sample to provide a referent potential that is used to
calculate results.
5. At positions 154 through 182, the cuvette washer aspirates the reaction mixture to waste and cleans
Finally, the cuvette washer aspirates the purified water and dries the cuvette.

Basics of Chemiluminescence
Chemiluminescent microparticle immunoassay (CMIA) is a detection technology used to measure
analyte concentration.
The CMIA technology detects the presence of antigens, antibodies, and analytes in patient samples.
The following reactants are the necessary reactants for CMIA detection technology:

D / ZĞĂĐƟŽŶ^ĞƋƵĞŶĐĞ
A CMIA reaction sequence is the order of interactions between the analyte in the sample and the
reactants. The sequence is specific to the assay protocol.
The following two-step sequence illustrates the basic principles of a reaction:
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.
The CMIA optical system performs a background read.
7. 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.
¥ For video associated with information above, see the Alinity ci-series
Operations Manual, Section 3 Principles of Operation>Principles of
Operation (i-series)>CMIA method (i-series)>CMIA technology and
reaction sequence.

i-series Process Path

Based on the protocol type, assay-processing steps occur at different positions on the process path.
The following are the assay protocols or assay-processing methods on the instrument.
· Assay processing for One Step 25 (i-series).

· Assay processing for Two Step 18-4 (i-series).
· Assay processing for pretreatment (i-series).
· STAT assay processing for One Step 11 (i-series).
· STAT assay processing for Two Step 4-4 (i-series).
Many kinds of assay-processing activities occur between sample aspiration and final result reporting.
Movements of the process path, the timing of these movements, and positions of components cause
each reaction activity to occur at a specified time and location.

Process Path Basic Flow

Chemiflex technology provides you with a variety of protocols or assay processing methods.
Depending on the type of protocol, assay processing steps occur at different positions on the process
path.
The steps in the table below describe the general assay processing activities and the CMIA reaction
that occurs in an i-series. These steps are not specific to a particular assay protocol.
ĂƐŝĐWƌŽĐĞƐƐŝŶŐ ĐƟǀ ŝƟĞƐ
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. Nmethylacridone forms and releases energy
(light emission) as N-methylacridone returns to its ground state.
9. The CMIA optical system measures the chemiluminescent emission (activated read) over a

predefined time period to determine a result.
¥ Based on the protocol type, assay-processing steps occur at different

positions on the process path
Assay Processing Videos

For more information regarding the assay-processing steps that occur for specific assay protocols or
assay-processing methods watch the videos in Section 3 of the Alinity ci-series operation manual as
instructor directed.
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

Review
1. Select all of the following reactants and analytes that are necessary for chemiluminescent
microparticle immunoassay (CMIA) detection technology: (select all that apply)
a. Trigger Solution
b. Paramagnetic microparticles coated with capture molecules (antigen, antibodies, or viral particles)
that are specific for the analyte being measured
c. Pre-Trigger Solution
d. Sample analyte that is measured
e. Acridinium-labeled conjugate
f. Alkaline Wash
2. The CMIA optical system measures the sample absorbance for the quantification of analyte
concentration.
a. True
b. False
3. The sample interference indices protocol could be used if a sample was hemolyzed.
a. True
b. False

4. Select all of the electrolytes measured by the integrated chip technology (ICT): (Select all that
apply)
a. Magnesium (Mg)
b. Carbon Dioxide (CO2)
c. Chloride (Cl-)
d. Sodium (Na+)
e. Potassium (K+)

10 QC Analysis
ϭŚŽƵƌ
Module Topics
Quality control analysis is the process by which quality control (QC) data is monitored. QC data
includes both unreleased and released control results.
· Levey-Jennings graphs
· Westgard rules
· Control range tracking
· QC data summaries
K ďũĞĐƟǀ ĞƐ
o Explain quality control analysis including Westgard Rule application
o Describe the Levey-Jennings (Graph) screen
o Perform Levey-Jennings procedures
o Describe the Quality Control Summary screen

are:

control orders and Quality control analysis

QC Analysis
Analyze QC Data
The Alinity ci-series monitors QC data through:
· Control range tracking

· Westgard rules
· QC data summaries
· Levey-Jennings graphs
Control results for an assay are evaluated at completion:
· The Alinity ci-series compares a completed control result 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 that are marked as excluded are not considered.
· All Westgard rules that are enabled for the assay are evaluated.
Control Screen
Under the Configure screen, Assay tab, the Quality Control screen can be used by a supervisor
log on or higher to configure, import, edit and delete multi-constituent and single-constituent
controls. Operators can view quality control settings.
Control expected mean and SD values must be entered to enable utilization of quality control reports,
Levey-Jennings graphs, and quality control summary data.

QC Analysis
Use of the Quality Control screen and control configuration options will be covered in more detail in
the Configuration Options module.
Westgard Rules
When Westgard rules are configured, the operator can view the Westgard rule settings for each assay
installed on the system on the Westgard screen.
Westgard rules that are configured as a failure are evaluated first, and then the rules that are
configured as a warning are evaluated. The default settings are:
· Rule 1-2s is a warning.

· Rule 1-3s is a failure.
Only Westgard rules that are configured with failure criteria produce a CNTL flag for a specimen
result.

QC Analysis
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
· 10-1M
· 10-x xM
Quality Control Summary screen

On the Quality Control Summary screen, the operator can view the statistical data for all assay
control levels.
¥ NOTE: Statistical calculations are performed for all released results,

including quality control results for a specific processing module, assay,
control name, lot number, and level combination.
The quality control summary data is not displayed if the values for expected mean and expected
standard deviation (1 SD) are not defined for the control.
· 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.

QC Analysis
To view the QC Summary screen, on the menu bar, tap QC.
To display the QC summary data for one module, tap a Module button. Module 6 displays the quality
control summary data for calculated assays.

QC Analysis
Clear a Control Failure

The system administrator can clear a control failure for an assay for a specific control, lot number,
and level.
An assay control level that has a control failure is displayed in red text on the Quality Control
Summary screen
A control failure can occur as the result of a value that exceeds a control range or a Westgard rule
failure.
Tap the assay control level that has a control failure. In the Clear Control Failure flyout, the operator
can clear a control failure by tapping Clear Control Failure.
A comment is required when a control failure is cleared. When you enter a comment, Informational
message code 1171 is generated in the System Logs. The comment is included in the message text.
After the control failure is cleared, the text of the assay control level is displayed in black
¥ To perform actions on the QC Summary screen refer to the Alinity ci-

Quality Control Analysis>Quality Control Summary screen
-Quality control>Quality control analysis>Clear a control failure
-Quality control>Quality control analysis>View the quality control (QC)

summary data
-Quality control>Quality control analysis>View the control summary

details
Levey-Jennings (Graph) screen

On the Levey-Jennings (Graph) screen, the operator can perform the following functions:
· 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.

QC Analysis
· 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

QC Analysis
Create a Levey-Jennings Graph

Levey-Jennings Graphs are created from the QC Summary screen.
The previous selections for module, assay, control name, lot number, control level, and date range are
displayed on the Quality Control Summary screen.
To create a Levey-Jennings Graph begin by tapping a Module button to display the QC summary
data for one module, tap module 6 to display the QC summary data for calculated assays.
Set the Date Range:
· The default Date Range is composed of the last 31 days, including the current date.
· To edit type a value in the Date Range box and type a value in the To box.
· Tap Update.
In the list of QC summary data, tap a maximum of six assay control levels for the same assay, control
name, and lot number. Then Tap Graph.
· To filter the list of QC summary data, tap Search.

· The Graph button is unavailable if more than one assay or lot number is selected on the Quality
Control Summary screen.
On the Levey-Jennings (Graph) screen, tap a comparison type in the Comparison Type drop-down
list. There are four choices:
1. None: A comparison method is not used.
2. Manufacture: compares the expected mean and expected SD to the manufacturer’s mean and SD
that are configured for the control.
3. Module Cumulative: compares the expected mean and expected SD to the cumulative mean and
cumulative SD of the selected module.
4. System Cumulative: compares the expected mean and expected SD to the cumulative mean and
cumulative SD of all modules in a multimodule system.
Point Details Screen

Once a Levey-Jennings graph is created the operator can perform the following functions from the
Point Details screen::
· Display the value for a Levey-Jennings point

· Exclude or include a Levey-Jennings point
· View the details for a Levey-Jennings point

QC Analysis
· Add a comment to a Levey-Jennings point
The Points Details screen is accessed by tapping a point on the created Levey-Jennings graph.
Exclude or include a Levey-Jennings point

The system software automatically excludes a control result that exceeds a value that is six times the
expected standard deviation (SD).
After a point is included or excluded, the system software recalculates the cumulative mean, SD, and
sample size for the quality control (QC) data. Excluded points are not included in the recalculation.
The system software does not recalculate the Westgard data if more than 5000 QC data points are
pending an adjustment

QC Analysis
¥ To perform actions on the Levey-Jennings (Graph) screen refer to the

subsection; Quality Control Analysis>Levey-Jennings (Graph) screen
¥ To locate the procedure using the online Procedure Map ref to the
-Quality control>Quality control analysis>Display the value for a Levey-

Jennings point
-Quality control>Quality control analysis>Exclude or include a Levey-

Jennings point
-Quality control>Quality control analysis>View the details for a Levey-

Jennings point
-Quality control>Quality control analysis>Add a comment to a Levey-

Jennings point.
ĐƟǀ ŝƚǇϭ
Levey-Jennings point
1. Select a control and view a Levey-Jennings graph. Record the control and the date range
selected.
2. Using the Levey-Jennings graph created, identify a point and record its value.
3. Record the date and time the control point was run.
4. Exclude that point.
5. Using the selected control point, add a comment. Record the comment and verify that the
comment appears with the point.
ĐƟǀ ŝƚǇϮ
Clear a Control Failure
1. If there is a control that is out of range or failed a Westgard rule, clear the control flag from patient
results.

QC Analysis
ĐƟǀ ŝƚǇϯ
View the quality control (QC) summary data
1. Select a different control and view the summary date. Record the control and the date range
selected
Review
1. QC data includes both unreleased and released control results.
a. True
b. False
2. When Westgard rules are configured, upon completion of the control the system compares a control
results against the expected mean and standard deviation for the control level.
a. True
b. False
3. Control results for an assay are evaluated at completion against all Westgard rules that are enabled
for the assay.
a. True
b. False

QC Analysis
4. Select all of the following functions the operator can perform on the Levey-Jennings graph screen:
a. Include or exclude points from the Levey-Jennings graph.
b. 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.
c. Add a comment to a Levey-Jennings point
d. 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.

11 ĚĚŝƟŽŶĂůD ĂŝŶƚĞŶĂŶĐĞ
ϰŚŽƵƌƐ
Module Topics
A thorough maintenance program minimizes downtime, maintains records for inspection and
accreditation, and maintains system performance to provide optimal test results. This module will
provide you with basic knowledge about performing maintenance.
· Maintenance suggestions
· Maintenance tab
K ďũĞĐƟǀ ĞƐ
o Perform Weekly, Monthly, Triannual, Quarterly, Semiyearly, and

As-Needed maintenance procedures
o Review and approve the Maintenance Log
o Identify hardware components replaced or cleaned during

Weekly, Monthly, Triannual, Quarterly, Semiyearly or As-Needed
maintenance

are:
Section 9 Service, Maintenance and diagnostics subsections; Maintenance

and diagnostics, Procedures Log screen and Maintenance procedure
descriptions

Additional Maintenance
Maintenance
The system software provides a user-friendly interface to perform and track maintenance and
diagnostic activities.
The Procedures screen displays maintenance and diagnostic procedures that can be performed.
· The Maintenance tab includes scheduled procedures to perform and as-needed cleaning
procedures to perform.
· The Diagnostics tab includes procedures that can be used to confirm the status of assemblies and
mechanisms to help identify and resolve operational problems
Each maintenance category is represented by a tab on the right side of the Maintenance tab of the
Procedures screen.
Any procedure that is displayed can be performed even if it is not scheduled.
After initiating a procedure, follow step-by- step instructions through the procedure to completion.
Procedures may have pictures and videos associated with them to assist, it is important to always also
read the steps of the procedure before hitting proceed to go to the next steps.

The online log indicates the date and time that the procedure is completed. The performance of the
procedure is tracked in the online log.

Review the procedure key setting. The key setting for each procedure can be found in the Procedure
Details flyout.
The operator should be familiar with the names and locations of hardware components that
are replaced or cleaned during weekly, monthly, triannual, quarterly, semiyearly or as needed
maintenance.
Weekly Maintenance
The following are the required Weekly Maintenance procedures for both instruments:
c-series
· Clean cuvettes with Detergent A
4 Automated procedure. Takes 30 minutes to complete.
i-series
· Manual Pipettor Probe Cleaning
4 All three pipettors are cleaned with purified water and a lint free cloth to remove salt buildup.
· Manual Wash Zone Probe Cleaning
4 All three probes on wash zone 1 and wash zone 2 are cleaned to remove salt buildup. Clean each
wash zone manifold where the probe enters the manifold.
· Manual Wash Cup Cleaning
4 The baffle will fit into the wash cup either way, it is very important to place it into the cup the
correct way with the tab towards the valves and away from the pipettor.
Monthly Maintenance
Below are required Monthly Maintenance procedures.
c-series
4 Clean ICT Drain Tip
i-series
There is no required Monthly Maintenance on the i-series.

c-series Triannual Maintenance

Change 1 mL Syringes
There are seven total 1 mL syringes. All 7 syringes must be replaced during routine quarterly
maintenance if the system is configured to use the ICT module system. It if is not configured to use the
ICT Module, only the three wash solution 1 mL syringes are changed.
· Two are located in the ICT aspiration pump.

· Two in the ICT reference solution pump.
· Three in the wash solution pump.
Check and Change ICT Check Valves
There are 3 total ICT Check Valves in the pump center on the ICT reference solution pump and ICT
aspiration pump. Both ICT reference solution pump check Valves must be checked during routine
quarterly maintenance. The check valve on the ICT aspiration pump must be replaced.
ŚĞĐŬĂŶĚůĞĂŶ, ŝŐŚͲŽŶĐĞŶƚƌĂƟŽŶ
Waste Sensor
· This procedure is required only if the high-concentration waste bottle is installed.

Quarterly Maintenance
Below are required Quarterly Maintenance procedures
c-series
1. Wash solution pump
2. ICT Reference Solution pump
3. ICT aspiration pump
4. ICT aspiration valve
5. Sample Syringe
6. Reagent 1 Syringe
7. Reagent 2 Syringe

Sample Syringe Maintenance
NOTES FOR SAMPLE SYRINGE MAINTENANCE, WASH SOLUTION SYRINGE

MAINTENANCE, AND REAGENT SYRINGE MAINTENANCE:
¥ Note: These procedures might be best to be done with two people so that
one person can read the instructions on the screen, while the other person
sits in front of the syringes and performs the steps.
¥ Note: It is important to be gentle with the tubing connections and to not

overtighten.
¥ Note: The procedure will perform a flush after completion, it is important

to watch the syringes and make sure there are no bubbles or leaks.
If bubbles are present you should go under diagnostics and perform
additional syringe flushes.
This maintenance procedure replaces the sample syringe O-ring and sample syringe seal tips 1 and 2.
This procedure involves four major steps:
1. Removing the sample syringe
2. Removing the O-ring and Seal Tips 1 and 2
3. Installing new O-ring and Seal Tips 1 and 2
4. Installing the Sample Syringe

t ĂƐŚ^ŽůƵƟŽŶ^ǇƌŝŶŐĞD ĂŝŶƚĞŶĂŶĐĞ
· There are two wash solution syringes located behind the 1mL syringes on the Wash Solution Pump.
The quarterly maintenance procedure replaces wash solution syringes O-ring and seal tips 1 and 2
· This procedure involves six major steps:
1. Remove the 1ml syringes on the Wash Solution Pump
¥ NOTE: When you remove these tubings, you may want to use tape to label
them Left, Middle, Right so that it is easier when you put the syringes
back in place.
2. Removing the Wash solution syringe
3. Removing O-ring and Seal Tips 1 and 2
4. Install O-ring and Seal Tips 1 and 2
5. Install Wash Solution Syringe
6. Reseat the 1ml syringes on the Wash Solution Pump.
Reagent Syringe Maintenance

· There are two reagent syringes: 1 and 2. The quarterly maintenance procedure replaces reagent
syringe O-ring and seal tips 1 and 2
· This procedure involves four major steps:
1. Removing the Reagent syringes
2. Removing the O-ring and Seal Tips 1 and 2
3. Installing new O-ring and Seal Tips 1 and 2
4. Installing the Reagent Syringes.

Change Lamp
· Wear gloves when performing this procedure. Residual oil from an ungloved hand on the glass
surface of the lamp shortens the lamp life.
· Be careful when removing the lamp it will be hot.
· The lamp requires a 30 minute warm-up period after replacement before any assay processing can
be performed.
· Perform quality control testing before assay processing
¥ Note: There is currently no requirement to power on the module to check

for stray light to confirm the lamp is seated correctly prior to replacing the
instrument covers.

Inspect Wash Cup Tubing

· The operator should inspect the wash cup tubing for any discoloration or obstruction.
¥ Note: It is important to watch the video associated with the procedure to

confirm that the correct tubing is being inspected.
· If tubing discoloration or obstruction is found, As-Needed procedure 5901 Clean Wash Cups
(c-series) is required to be performed. This procedure instructs on decontamination of the wash
cups.
i-series
The i-series has no Quarterly Maintenance requirements.

Semiyearly Maintenance
The following are the required Semiyearly procedures.
c-series
The c-series has no Semiyearly Maintenance requirements
i-series
Air Filter Cleaning Rotating between two sets of air filters is recommended because the filters must be
dry when they are reinstalled.
¥ To locate maintenance procedure refer to the Alinity ci-series Operations

Manual Section 9 Service, maintenance and diagnostics
-Maintenance>Perform maintenance>Perform a maintenance procedure

or a diagnostics procedures
-Maintenance>Perform maintenance>Weekly maintenance procedures

(i-series)
-Maintenance>Perform maintenance>Weekly maintenance procedures

(c-series)
-Maintenance>Perform maintenance>Monthly maintenance procedures

(c-series)
-Maintenance>Perform maintenance>Triannual maintenance procedures

(c-series)
-Maintenance>Perform maintenance>Quarterly maintenance procedures

(c-series)g

ĐƟǀ ŝƚǇϭ
Perform the i-series Weekly Maintenance
1. Perform all Weekly Maintenance procedures using the video in the procedure as a guide.
ĐƟǀ ŝƚǇϮ
Perform the c-series Monthly
Maintenance procedure
1. Perform the c-series Monthly Maintenance using the video in the procedure as a guide.

ĐƟǀ ŝƚǇϯ
Perform c-series Quarterly
Maintenance procedures
1. Perform the Quarterly Maintenance procedures identified by your facilitator using the instructions
and videos in the procedures as a guide.
o 5801 Sample Syringe Maintenance .
o 5802 Wash Solution Syringe Maintenance .
o 5803 Reagent Syringe Maintenance . Perform on R2 only.
o 5806 Change Lamp .
o 5808 Inspect Wash Cup Tubing: Inspect the wash cup tubing for any
discoloration or obstructions.
ĐƟǀ ŝƚǇϰ
Perform the c-series Weekly
1. Perform the c-series Weekly Maintenance procedure.

ĐƟǀ ŝƚǇϱ
Perform the c-series Triannual
1. Perform the Triannual Maintenance procedures.
o 5833 Change 1 mL Syringes . Replace one 1 mL syringe.
o 5834 Check and Change ICT Check Valves (c-series). Replace one ICT
check valve.
o 5835 Check and Clean High-Concentration Waste Sensor . This procedure

is only performed if the system is installed with a high concentration
waste bottle.
ĐƟǀ ŝƚǇϲ
Perform the i-series Semiyearly Maintenance procedure
1. Perform the i-series Semiyearly Maintenance procedure.

As-Needed Maintenance
There is another category of maintenance called As-Needed Maintenance. These are a wide range of
established maintenance procedures that you may need to perform for troubleshooting purposes or in
response to an operating error.
The operator can perform as-needed maintenance procedures for the c-series processing module
to clean cuvettes and module-specific reagent and sample manager (RSM) mechanisms when
messages codes and observed problems associated with the cuvettes and the module specific RSM are
diagnosed.
The operator can perform as-needed maintenance procedures for the i- series processing module
to clean and decontaminate the processing module or module-specific reagent and sample manager
(RSM) mechanisms after a spill has occurred or when message codes and observed problems
associated with the processing module or the module-specific RSM are diagnosed.
The following are As-Needed Maintenance procedures for both instruments:
c-series
· Clean Wash Cups
· Clean Sample and Reagent Probes
· Clean Mixers
· Clean Cuvette Washer Nozzles
· Wash Cuvettes
· Manual RSM Loading Area and Positioners Cleaning
i-series
Manual RSM Loading Area and Positioner Cleaning

Reagent and Sample Manager (RSM)

maintenance procedures
Maintenance procedures for the reagent and sample manager are grouped by the module type and by
frequency categories on the Maintenance tab of the Procedures screen.
The operator can perform the as- needed maintenance procedure for the reagent and sample manager
(RSM) to clean RSM mechanisms after a spill has occurred or when message codes and observed
problems associated with the RSM are diagnosed.
¥ NOTE: The as-needed maintenance procedure for the reagent and sample
manager (RSM) contains instructions for how to clean the RSM barcode
reader if errors are occurring.
RSM
· 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.
Procedures Log Screen

On the Procedures Log screen, the operator can view information about maintenance and
diagnostic procedures that were performed.
The system stores data for a maximum of 2 years. The operator can perform the following functions:
· Approve a log.
· Print a log.
· Add a comment to a procedure.
Maintenance Tab
The Maintenance Tab displays the maintenance logs.
The following table explains the descriptive elements of the maintenance logs:

Element Description
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.

Blue box Indicates that the procedure has been performed and has a status of
Completed.

Asterisk (*) within Indicates that a comment has been entered for the procedure in the
the box Details for Log flyout.
Number within the Indicates that the procedure was performed multiple times on the same
box day.
No box Indicates that the procedure was not performed or scheduled for that
day.
ŝĂŐŶŽƐƟĐƐdĂď
The Diagnostics Tab displays the diagnostic logs.
The following table explains the descriptive elements of the diagnostic logs:
Element Description
Gray box Indicates procedures that did not complete successfully. If the procedure
is performed multiple times on the same day, the status of the last
performed procedure is displayed.

Blue box Indicates that the procedure has been performed and has a status of
Completed.

Asterisk (*) within Log flyout.
the box
Number within the Indicates that the procedure was performed multiple times on the same
box day.
No box Indicates that the procedure was not performed or scheduled for that
day.

Adding a Comment to a Procedure

You may want to add a comment to a procedure if there is a reason why the procedure was not
completed, why a procedure failed or was completed multiple times. You may also want to comment
why a nonscheduled procedure was performed.
Add Comment
1. On the menu bar, tap Procedures.
4 If Procedures is not an icon on the menu bar, tap System, and then tap Procedures
2. On the Procedures screen, tap Log.
3. On the Log screen, tap a Module button.
4. In the Activity Month area, tap the Right Arrow and Left Arrow buttons to display the needed
month.
5. Under Procedure, find the needed procedure.
4 If the procedure is not displayed on the screen, flick up and down to view more procedures.
6. To display the procedure in the Details for Log flyout, tap a date for the procedure.
7. If the procedure was performed multiple times on that date, tap Next or Previous to display the
details for each time that the procedure was performed.
8. In the Comments box, type a comment.
9. To save the comment and return to the Log screen, tap Done.
4 To discard the comment and return to the Log screen, tap Cancel.
If a completed procedure icon has * in it, that means a comment was entered for that instance.

Approving the Maintenance Log

The System Administrator reviews and approves the Maintenance Log on a regular basis.
Once a new month starts, the Maintenance Log for the previous month is available for approval ---
you cannot approve a current or future month.
Comments may still be made after the log is approved, but will reflect the date and time of the original
approval.
¥ To locate maintenance procedures refer to Alinity ci-series Operations

-Maintenance>Approve a maintenance log>Approve a maintenance log.
ĐƟǀ ŝƚǇϳ
Add Comment to Maintenance Procedure
1. Add a comment to an c-series Monthly Maintenance procedure once it has been performed.
2. Add a comment to an i-series Weekly Maintenance procedure once it has been performed
ĐƟǀ ŝƚǇϴ
Review the Maintenance Log
1. Review the Maintenance Log.
2. If a previous month’s log has not been approved, approve the log

Review
1. The Maintenance tab includes scheduled and As-Needed Maintenance cleaning procedures to
perform.
a. True
b. False
2. In which one of the following time frames do you approve a Maintenance Log?
a. Annually
b. Weekly
c. Monthly
d. Daily
3. What screen does the operator access to view scheduled and in process maintenance?
a. Supplies
b. System
c. Alert Center
d. Procedure

Common Errors and
12 dƌŽƵďůĞƐŚŽŽƟŶŐ
ƐƟŵĂƚĞĚdŝŵĞ͗ ϭ͘ ϱŚŽƵƌƐ
Module Topics
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.
· System troubleshooting
· System diagnostics
· Miscellaneous corrective action procedures

Common Errors and Troubleshooting
K ďũĞĐƟǀ ĞƐ
o Describe the troubleshooting process
o Describe and use the Alert Center
o View Message codes
o View the probable cause and corrective action for a message
o Describe what the operator can view and perform on the System
Logs screen
o View Observed problems
o Perform an emergency shutdown
o Perform a Diagnostic Procedure
o Use diagnostic procedures to resolve system issues

are:
-Section 10 Troubleshooting
-Section 9 Service, maintenance, and diagnostics

dƌŽƵďůĞƐŚŽŽƟŶŐƉƉƌŽĂĐŚ
To identify and resolve operational problems, become thoroughly familiar with normal system
operation.
An effective troubleshooting approach requires a logical, step-by-step process to resolve problems.

This type of approach focuses on the following activities:
· Observation, recognition, and categorization of symptoms

· Identification of the probable cause
· Systematic elimination of each potential cause of the problem from most likely to least likely
dƌŽƵďůĞƐŚŽŽƟŶŐD ŽĚĞů
The following troubleshooting model describes a five-step approach to defining symptoms, identifying
root causes, and implementing solutions.
To troubleshoot the system, include considerations that are appropriate to the laboratory
environment.
Step 1: Observe and Recognize Symptoms
To properly analyze and resolve a problem, investigate what is incorrect and observe what is correct.
Symptoms help to identify the problem area and to eliminate areas that operate correctly.
Example of Symptoms include:
· Message codes
· Observed problems such as a noise, a fluid leak, a monitor that flickers, or a trend in controls
Step 2: Categorize the Symptoms
To eliminate symptoms automatically as probable causes, classify symptoms by categories. Categories

of symptoms include:
· System
· Reagents
· Operator
· Environmental

^ƚĞƉϯ ͗ /ƐŽůĂƚĞZŽŽƚĂƵƐĞĂŶĚƌĞĂƚĞ ĐƟŽŶWůĂŶ
Based on the probable causes that are identified, devise a plan that first addresses the most likely
cause and then progresses to the least likely cause.
Address one probable cause at a time to isolate the resolution, and then apply the resolution to a
specific problem.
Diagnostic resources and tools include:
· Message codes and messages

· System logs
· Control information
· Maintenance and diagnostic procedures
Utilize the System Help, Alinity ci-series Operations Manual and product documentation such as
reagent and consumable information.
Step 4: Resolve the Problem
Carefully perform the steps required to solve the problem.
Problems can be resolved by the following actions:
· Make adjustments, such as tighten connections

· Perform a calibration
· Replace or repair system components
· Run new controls
^ƚĞƉϱ͗ s ĞƌŝĨǇƚŚĞZĞƐŽůƵƟŽŶt ŽƌŬĞĚ
Verify that symptoms do not occur:
· Perform the appropriate verification procedure

· Confirm control values if appropriate
If symptoms continue to occur, perform the steps to resolve the next most likely problem. Repeat this
process until the problem is resolved.

Alert Center
The Alert Center button is located in the upper left corner of the Home Screen.
Status indicators called badges are displayed on icons to notify the operator when a specific system
problem requires attention:
Red triangle (alert): indicates system problems that require immediate attention.
Amber circle (notification): indicates system problems that require attention that is not immediate.
Pressing the Alert Center button displays the Alert Center flyout that contains alert and notification
messages for system problems that require attention.

Alert Center Flyout

In the Alert Center flyout, the operator can:
· View the last 25 alerts and notifications. After 25 are reached, the message codes are first-in, first
out.
· View the probable cause and corrective action for a message.
· Clear all messages.
· Delete a single message.
Messages are sorted based on newest to oldest. There are three tabs in the Alert Center flyout:
· All tab - Displays all alert and notification messages generated.

· Alerts tab - Displays all alert messages generated.
· Notifications tab - Displays all notification messages generated.
¥ NOTE: Critical messages (which are generated via a pop-up) are not
stored in the Alert center flyout. When a critical message is acknowledged,
it goes into the System Logs.
Access System Logs

The Show Logs function button navigates to the System Logs screen.
ĐĐĞƐƐWƌŽďĂďůĞĂƵƐĞĂŶĚŽƌƌĞĐƟǀ ĞĐƟŽŶ
? Message displays Help from the operations manual for the selected message code. This displays
the probable cause and corrective action from operations manual for the selected message. Probable
causes are listed from most likely to least likely in occurrence.
? displays Help from the operations manual for the active screen, flyout, or message code.

Clear All Messages / Delete Message

The operator can clear all messages in the Alert Center flyout or delete a single message.
· Clear All messages: Select the Clear All function button. A message requesting confirmation to clear
all messages in the Alert Center is displayed.
· To delete a single message: Tap the message to delete, and then tap the Close button in the upper-
right corner of the message box.
Cleared messages are retained in system logs
¥ To Access the Alert Center Flyout refer to the Alinity ci-series Operations
Manual Section 10 Troubleshooting
-Troubleshooting>Alert Center flyout>View the probably cause and

corrective action for a message.

Message Codes and System Logs

Message Codes are divided into 10 sections that reflect the major categories in which errors may
occur.
1. General Message Codes (0001-0999)
2. Assay-specific Message Codes (1000-1999)
3. Maintenance and Diagnostic Message Codes (2000-2999)
4. Level Sense and Fluidics Message Codes (3000-3999)
5. Optics and Bar code Reader Message Codes (4000-4999)
6. Robotics and Sensor Message Codes (5000-5999)
7. Support System Message Codes (6000-6999)
8. Temperature Message Codes (7000-7999)
9. Computer Hardware Peripheral Message Codes (8000-8999)
10. Software Message Codes (9000-9999)
Probable causes and associated corrective actions are provided for each Message Code in the Alinity
ci-series Operations Manual.
Corrective actions may involve hazardous activity. Follow directions and safety information provided
in the Alinity ci-series Operations Manual.
¥ If the corrective actions for a Message Code do not resolve the problem,
contact the local representative or find country-specific contact
information at www.corelaboratory.abbott.

System Logs
The System Logs screen contains the following tabs:
Tab Description
All messages A record of all system messages that can be used to troubleshoot
problems associated with system performance and results
reporting.
Alerts and A record of alerts, critical and noncritical messages.
notifications
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.
Interfaces A record of host interface communication messages.
Abbott Mail A record of Abbott Mail activities and status messages.
The Abbott Mail tab has four mail categories:
· Assay File
· Assay Insert
· System Update
· Calibrator Data
The operator can perform the following functions on the System Logs screen:
· Print a log.
· Search for specific log data.
· Message Help.
Message codes can be filtered by message types and message categories by selecting the appropriate
tab.
Cleared messages from the Alert Center are retained in system logs.

ĐƟǀ ŝƚǇϭ
View a Message Code
1. From the System Logs screen, view a Message Code.
2. Then view and list the probable cause and steps to correct the problem.

ĐƟǀ ŝƚǇϮ
Use Alert Center to view Message Code
1. From the Alert Center, view a Message Code.
2. Then view and list the probable cause and steps to correct the problem.
Observed Problems
Observed problems provide information about problems that may occur on the system and provide
corrective actions that help to resolve the problems.
Areas of Observed Problems include:
· Processing Module
· Sample Results
· User Interface (UI) computer
· Printer

Emergency Shutdown
To perform an Emergency Shutdown, power off the processing module and reagent and sample
manager using the main power breaker at the rear of the instrument.
To remove all power to one or more of the processing modules and the reagent and sample manager,
unplug the power connector from the power supply for each processing module and the SCM.
¥ To troubleshoot procedures refer to the Alinity ci-series Operations

Manual Section 10 Troubleshooting
-Troubleshooting>System cycle power, start, pause, and stop>Perform an

emergency shutdown

ĐƟǀ ŝƚǇϯ
View an observed problem
1. Using the Operations manual (Help), view an observed problem and list the probable cause and
steps to correct the problem.
Observed Problem Recommendation:
4 A procedure failed and a procedure item remained in the reagent carousel
ŝĂŐŶŽƐƟĐWƌŽĐĞĚƵƌĞƐ
A thorough diagnostics program gives the operator the tools to identify and resolve operational
problems and verify that a problem has been resolved.
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.
To view or perform a diagnostic procedure begin by selecting the Procedures icon in the Menu Bar.
· If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.

The Procedures screen displays maintenance and diagnostic procedures that can be performed. On
the Procedures screen, tap on the Diagnostics tab, then tap a Module button.
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 of 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
· Fluids-wash
· Temperature
· RV loader (i-series)
· Process path (i-series)
· Sample management
· Reagent management
· Module
· Utilities
· Reaction mechanisms (c-series)
· ICT (c-series)
Maintenance and diagnostic procedure status refers to the completion status of a procedure and were
reviewed in Training Module 5 Daily Maintenance.
Common diagnostics procedures might include pipettor calibrations (sample and reagent for both
c-series and i-series) and RSM calibration (can be used if the RSM is giving pick errors and seems not
to be aligned).
¥ To perform a diagnostic procedure refer to the Alinity ci-series Operations

-Maintenance>Perform maintenance>Perform a maintenance procedure

or a diagnostic procedure
-Maintenance>Document comments to a procedure>Add a comment to a

maintenance procedure or a diagnostics procedure.

ĐƟǀ ŝƚǇϰ
WĞƌĨŽƌŵĂĚŝĂŐŶŽƐƟĐƉƌŽĐĞĚƵƌĞ
1. Perform a diagnostic procedure designated by your facilitator. It is recommended that a pipettor

calibration (c and i-series) and the RSM calibration be performed.
2. Begin the procedure.
3. Leave the procedure while it is in process.
4. Return to the procedure and complete the procedure.

ĐƟǀ ŝƚǇϱ
ĚĚĂĐŽŵŵĞŶƚƚŽĂĚŝĂŐŶŽƐƟĐƉƌŽĐĞĚƵƌĞ
1. Add a comment to a diagnostic procedure.
ĐƟǀ ŝƚǇϲ
ZĞǀ ŝĞǁ ƚŚĞĚŝĂŐŶŽƐƟĐůŽŐ
1. Review the diagnostic log.
D ŝƐĐĞůůĂŶĞŽƵƐŽƌƌĞĐƟǀ Ğ ĐƟŽŶ

Corrective action procedures are a series of steps that are recommended to resolve a probable cause
associated with a message code or an observed problem. These procedures are common to more than
one message code or observed problem.
Instructor Demonstration
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).
· Manually unload a cartridge or rack from the reagent carousel.

Racks may have to be manually removed from the sample positioners in the following situations:
· 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.
ŽƌƌĞĐƟǀ ĞĐƟŽŶs ŝĚĞŽƐ

Refer to the online Operations Manual for instruction. View the videos to learn more about these
corrective action procedures
· 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).
· Manually unload a cartridge or rack from the reagent carousel.
There is also a fluidics-diagnostics procedure 1209 to empty i-series reservoirs.
¥ Refer to the Alinity ci-series Operations Manual Section 10

Troubleshooting, subsection Miscellaneous corrective action procedures
for information on replacing the i-series Bulk Solution Reservoirs.

¥ To locate troubleshooting procedures refer to the Alinity ci-series

Operations Manual Section 10 Troubleshooting
¥ To locate the procedures using the online Procedure Map to refer to the
-Troubleshooting>Reagent and sample manager (RSM) corrective action

procedure>Remove racks from the sample positioners
-Troubleshooting>Processing module corrective action procedures>Empty

the bulk solution reservoirs (c-series)

the bulk solution reservoirs (i-series)

the diluted wash buffer reservoir (i-series)
-Troubleshooting>Processing module corrective action

procedures>Manually unload a cartridge or rack from the reagent
carousel
ĐƟǀ ŝƚǇϳ
ZĞŵŽǀ ĞƌĂĐŬƐĨƌŽŵƚŚĞƐĂŵƉůĞƉŽƐŝƟŽŶĞƌƐ
1. Locate the procedure in the Operations Manual and then perform Remove racks from the sample
positioners.
ĐƟǀ ŝƚǇϴ
ŵƉƚǇĂďƵůŬƐŽůƵƟŽŶƌĞƐĞƌǀ Žŝƌ;ĐͲƐĞƌŝĞƐͿ
1. Locate the procedure in the Operations Manual and then perform Empty a bulk solution reservoir
(c- series).
ĐƟǀ ŝƚǇϵ
ŵƉƚǇĂďƵůŬƐŽůƵƟŽŶƌĞƐĞƌǀ Žŝƌ;ŝͲƐĞƌŝĞƐͿ
1. Locate the procedure in the Operations Manual and then perform Empty a bulk solution reservoir
(i- series)

Review
1. To access Diagnostic procedures, you must first tap the Alert Center.
a. True
b. False
2. Select all of the following that can indicate a system problem. (Select all that apply)
a. Sudden or unusual noise
b. Trend in controls
c. Message codes
d. Flickering Monitor
3. The Alert Center flyout displays alert and notification messages for system problems that require
attention.
a. True
b. False
4. 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/ON position.
a. True
b. False

5. Which one of the following steps do you complete first when emptying the bulk solution reservoir
(c-series)?
a. Start the processing module
b. Empty the reservoir and rinse it with purified water
c. Tighten the bulk solution level sensor cap
d. Open the bulk solution door and pull out the reservoir tray.
6. Which one of the following actions do you take to delete a single message from the Alert Center?
a. Delete the message from System Logs screen
b. Select the Clear All function button
c. Tap the message to delete, and then tap the Close button in the upper-right corner of the message
box.
d. There is no way to delete messages from the Alert Center
7. Select all of the following situations that prompt you to remove sample and vial racks from the
inner and outer sample positioners: (select all that apply)
a. A maintenance procedure or a diagnostic procedure has caused the instrument status of the
processing module or the RSM to transition unexpectedly to Stopped
b. Power to the processing module or the reagent and sample manager (RSM) is interrupted
c. An error has caused the instrument status of the processing module or the RSM to transition
unexpectedly to Stopped
d. An error has caused the instrument status of the RSM to transition to Paused

13 Basic Component Replacement
ϰŚŽƵƌƐ
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)
K ďũĞĐƟǀ ĞƐ
o View procedures for component replacement
o Replace components as needed (c-series and i-series)

are:
Section 9 Service, Maintenance and diagnostics subsection; Component

Replacement.

Basic Component Replacement
System Component Replacement

Replacing components due to normal wear from daily operations helps maintain system performance
to provide optimal test results.
Component Replacement
Component replacement involves three key tasks:
· Removal of the old component

· Installation of the new component
· Verification of the new component
The operator can find component replacement instructions in the online Operations Manual. The
procedure will inform if the procedure key is required to be in the On position.
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.
Following component replacement procedures, always review the operations manual for verification
procedures that must be performed after component replacement. It is also advisable to run Quality
Control as recommended to verify the system performance prior to reporting sample results.

Replace c-series
System Components
Certain c-system processing center components may need to be replaced because of normal wear from
daily system operation:
1) Sample probe (s)

2) Mixer 2
3) ICT module
4) Lamp
5) Mixer 1
6) Cuvette dry tip
7) Cuvette segment
8) Reagent probe (R1)
9) ICT probe
10) Reagent probe (R2)

ZĞĐŽŵŵĞŶĚĂƟŽŶƐĂŶĚE ŽƚĞƐ͗
· When removing the sample probe:
4 Loosen (but do not remove) the probe screw and the screw securing the sample probe ground
wire.
4 Be careful not to flare or stretch the sample probe tubing when installing the new sample probe.
4 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.
4 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.
4 Ensure the sample pipettor cover is not pinching the sample probe tubing and is secured
completely for correct level sensing. In order to seat the probe cover correctly, follow the
operations manual instructions to align the back of the probe cover vertically and then lower
down into place.
4 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 assay
- TIP: Your laboratory might want to create a user-defined maintenance procedure to
track this on the Alinity system software. Creating user-defined maintenance procedures
will be covered in Configuration.
- It is important to follow the operations manual instructions to calibrate the pipettor after
probe replacements
· When removing the cuvette dryer tip:
4 Wear gloves when replacing the cuvette dry tip to prevent residual oil from adhering to tip. The
oil interferes with the appropriate drying function of the cuvette dry tip.
4 Position the bottom of the cuvette dry tip 61 mm ± 0.5 mm from the underside of the cuvette
washer assembly. There is a groove on the metal portion of the cuvette dryer tip to help align this
properly.
· When the ICT module is replaced, the c-series processing module Supply status screen tracks
and maintains a record of the serial number, 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.
· Certain c-series supply and pump center components may need to be replaced because of normal
wear from daily system operation:
1. Sample syringe O-ring and seal tips 1 and 2
2. Reagent syringe O-ring and seal tips 1 and 2
3. Wash solution syringe O-ring and seal tips 1 and 2
4. Wash solution pump syringes (1 mL) and check valves
5. ICT Reference Solution pump syringes (1 mL) and check valves

6. ICT aspiration pump syringes (1 mL) and check valve
7. Bulk solution level sensor
¥ NOTE: Removal and replacement of the syringes and check valves listed
above was covered in training module 11: Additional Maintenance,
Scheduled Maintenance, c-series triannual and quarterly maintenance.
¥ Note: To locate component replacement procedures refer to the Alinity ci-

series Operations Manual Section 9 Service, maintenance and diagnostics
-Troubleshooting>Replace components>c-series>Processing center

component replacement (c-series)>Replace the sample probe (c-series)

component replacement (c-series)>Replace the cuvette dry tip (c-series)

component replacement (c-series)>Replace the ICT module or the ICT
probe (c-series)
Component Replacement Videos

The operator can find component replacement instructions in the online Operations Manual. View
the videos in the list below or as directed by your instructor to learn more about these component
replacement procedures.
· Remove Reagent Probe

· Replace Reagent Probe
· Remove Reagent Probe tubing
· Replace Reagent Probe tubing
· Remove Mixers
· Replace Mixers
· Remove Cuvette Segment
· Replace Cuvette Segment

ĐƟǀ ŝƚǇϭ
Replace c-series components
1. Locate the applicable procedure in the online Operations Manual.
2. Remove and Replace the following components:
4 Sample probe
4 Mixer
4 ICT module or ICT probe
3. Complete all applicable verification procedures.
Replace i-series
System Components
Certain i-series processing center components may need to be replaced because of normal wear from
daily system operation:
1. Sample pipettor probe (S)
2. Reagent pipettor probe (R2)
3. Wash zone 1 probes (WZ1)
4. Liquid waste arm probe
5. Reagent pipettor probe (R1)
6. Wash zone 2 probes (WZ2)
Certain supply center components may need to be replaced because of normal wear from daily system
operation:
1. Concentrated Wash Buffer level sensor
2. Trigger Solution level sensor
3. Pre-Trigger Solution level sensor

Certain optional components may need to be replaced because of normal wear from daily system
operation:
1. External waste pump
ZĞĐŽŵŵĞŶĚĂƟŽŶƐĂŶĚE ŽƚĞƐ
When replacing the process path light cover:
4 Ensure procedure key is in the On position.

4 Place the front right corner of the process path light cover directly behind the knurled screw, near
the STAT diverter (STD), on the process path.
4 Align the cables and tubing with the small notches at the bottom of the process path light cover
¥ Note: There are two different styles of light cover, one piece and two
piece. Follow the instructions in the operations manual for correct
placement. Confirm that no tubing is pinched or removed when cover
replacement occurs.
When replacing a sample or reagent pipettor probe:
· Ensure procedure key is in the On position.

· When connecting the probe tubing, align the probe tubing on the probe and rotate the probe fitting.
When replacing the wash zone probes:
· Before disconnecting the black wash zone monitor housing from the blue probe housing, invert the
probe block assembly so the wash zone probes are facing down. If separated with the probes facing
up, the probes may fall out of the assembly.
· 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.
The level sensors tubing connection is specific to the procedure. Follow the instructions exactly for the
correct orientation.
· Remove Level Sensor for Pre- Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
· Replace Level Sensor for Pre- Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
When replacing the diluted wash buffer level sensor the lock ring release tool is required to remove
the tubing.
· The tool can be found in the maintenance kit.

· Depending on the instrument configuration, a ground strap may need to be removed from the rear
fluidics panel before the panel can be removed. Replace the ground strap when the panel is replaced

¥ To locate component replacement procedures refer to the Alinity ci-series

Operations Manual Section 9 Service, maintenance and diagnostics
-Troubleshooting>Replace components>i-series>Processing center

component replacement (i-series)>Remove and replace the process path
light cover (i-series)

component replacement (i-series)>Replace a sample or reagent pipettor
probe (i-series)

component replacement (i-series)>Replace the wash zone probes
(i-series)
-Troubleshooting>Replace components>i-series>Supply center

component replacement (i-series)>Replace the level sensor for Pre-
Trigger Solution, Trigger Solution, or Concentrated Wash Buffer (i-series)
-Troubleshooting>Replace components>i-series>Supply center

component replacement (i-series)>Replace the diluted wash buffer level
sensor (i-series)
Component Replacement Videos

The operator can find component replacement instructions in the online Operations Manual. View
the videos in the list below or as directed by your instructor to learn more about these component
replacement procedures
· Remove Liquid Waste Arm Probe

· Replace Liquid Waste Arm Probe

ĐƟǀ ŝƚǇϮ
Replace i-series components
1. Locate the applicable procedure in the online Operations Manual.
2. Remove and Replace the following components:
4 Sample or reagent pipettor probe

4 Wash zone probes
4 Diluted wash buffer level sensor (Demo)
4 Level sensor for Pre-Trigger, Trigger or Concentrated Wash Buffer
3. Complete all applicable verification procedures

Review
1. 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.
a. True
b. False
2. Select all of the correct time intervals for the sample probe usage following replacement: (Select all
that apply)
a. One day
b. One year for systems not generating results for whole blood assays
b. Six months for systems generating results for whole blood assays
d. Three years
3. Select the materials required to replace the cuvette dry tip (c-series):
a. Gloves
b. Metric ruler
c. Cotton swabs
d. Bleach

4. Select all of the following cautionary statements you need to keep in mind when replacing wash
zone probes (i-series): (Select all that apply)
a. Hot Surface. This activity or area may expose you to hot surfaces.
b. Probe Stick Hazard. This activity or area may expose you to probes
c. Moving Parts. This activity or area may expose you to moving parts
d. Biological RISKS. This activity or area may expose you to potentially infectious material.
5. In order to verify the new sample or reagent pipettor probe (i-series), you need to perform a
pipettor probe calibration.
a. True
b. False
6. After replacing the bulk solution level sensor (i-series), you must perform the Fluidics-Wash
diagnostic procedure 1200 Flush and Prime Fluidics (i-series) for the appropriate bulk solution to
remove any air that may be present in the bulk solution lines.
a. True
b. False

7. Component replacement involves three key tasks: removal of the old component, installation of the
new component, and verification of the new component.
a. True
b. False
8. Select all of the following precautions when working with tubing: (Select all that apply)
a. If the tubing fit is loose replacing the tubing is recommended
b. Ensure tubing is not pinched or kinked
c. Check the tubing elasticity daily
d. Do not flare or stretch the tubing
e. The tubing needs to fit firmly on probe (do not push past bend of sample probe)

9. Which one of the following verifications do you need to perform after a component replacement
procedure:
a. Daily maintenance
b. Quality control testing to verify the system performance before reporting sample results
c. Calibration testing to optimize system performance before reporting sample results
d. Replenish RVs
10. Select all of the following cautionary statements you need to remember when performing any
c-series or i-series component replacement procedures: (Select all that apply)
a. CAUTION: Possibility of electric shock. This activity or area may expose you to potentially
infectious material
b. CAUTION: Biological RISKS. This activity or area may expose you to potentially infectious material
c. CAUTION: Hot Surface. This activity or area may expose you to hot surfaces
d. CAUTION. Moving Parts. This activity or area may expose you to moving parts
e. CAUTION. Probe Stick Hazard. This activity or area may expose you to probes
f. CAUTION. Chemical Hazard. This activity or area exposes you to a chemical hazard

14 ŽŶĮŐƵƌĂƟŽŶ
ϯ ŚŽƵƌƐ
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
K ďũĞĐƟǀ ĞƐ
After completing this module, you should be able to perform configuration tasks
from the:
o Configure screen, General tab
o Configure screen, Computer tab
o Configure screen, Assay tab
o Configure screen, Maintenance and Diagnostics tab

are:
Section 2 Installation procedures and special requirements subsection;

System Configuration

Configuration
ŽŶĮŐƵƌĂƟŽŶ^ĞƫŶŐƐ
Configuration settings define the information that the Alinity ci-series needs to meet laboratory
specific requirements. System configuration is performed after system installation. The system can be
reconfigured at any time if necessary.
Most system configuration settings require Supervisor or System Administrator access.
To access the Configuration screen,
1. On the menu bar, tap System, and then tap Configure.
¥ NOTE: The Configure command can be configured as an icon on the menu

bar and thereby is removed from the System menu.
The configure screen has four tabs:
1) General tab.
2) Computer tab.
3) Assay tab.
4) Maintenance and Diagnostics tab.

Configuration
Configuration
Follow along as your facilitator reviews the commonly used
configuration screens listed in this training module and
demonstrates how to perform common configurations.
General Tab
Screens that can be accessed from the General tab are:
1. Users.
2. User Profile.
3. Modules.
4. Printers.
5. Bar Codes.

Configuration
6. Reagents and Supplies.
7. Reports.
8. Abbott Mail.
Unless otherwise specified, System administrator access is needed to perform the configuration. The
operator can view the settings
¥ To locate configuration procedures refer to the Alinity ci-series Operations

Manual Section 2 Installation procedures and special requirements
-Setup>Configure general settings>Users>Create a new user
-Setup>Configure general settings>Printers>Add a printer
-Setup>Configure general settings>Printers>Verify a printer.
Users screen
The Users screen is used to:
· Create new users.

· Edit a user name, the access level, and the status.
· Reset a user PIN.
· Import and export user data.
The operator can search for a specific user.

Configuration
Create new users

On the Users screen, tap Create New User.
· An operator ID and a PIN must be created for an operator to log on to the system software and use
the system.
· The PIN requirement for general operator logon can be disabled
¥ To disable the General Operator Pin requirement, refer to Alinity

ci-series Operations Manual: Installation procedures and special
requirements>System configuration>Configure screen, Computer
tab>General Settings Screen>Configure general settings
¥ NOTE: Once a new user is created they can be put as a status of inactive,
but cannot be deleted from the system.
Edit users
On the Edit User screen, the system administrator can edit an existing user profile. In the Status
area of the Edit User screen, an existing user can be Inactivated or Activated.
System administrators can change their personal user PINs and the user PINs of other users.
Import/Export
A user file can be imported from a USB flash drive or exported for use on a different system.

Configuration
User Profile screen

On the User Profile screen, the operator can perform the following functions:
· Configure a personal display theme. This allows the user to change the menu bar to either a light
gray or dark gray, depending upon their preference.
· Change a personal user PIN.
From the User Profile screen general operators can change their personal user PINs but cannot
change the user PINs of other users.

Configuration
Modules screen
The Modules screen is used to configure module settings for i-series module, c-series module and the
reagent and sample manager (RSM). The configuration settings are:
· Module name.
· Number of assigned reagent carousel positions for onboard calibrators and controls.
· Location and number of priority sections.
· Specific parameters for each processing module and the RSM.
The supervisor can edit the quality control shift start time.
Printers screen
The printers screen is used to:
· 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.

Configuration
Add Printer Details
To Add a Printer, on the Printers screen, tap Add Printer.
· In the Add Printer flyout, enter the following information:

4 Name
4 IP Address (xxx.xxx.xxx.xxx)
4 Paper Size
4 Print on Both Sides
4 Driver (Choose a universal or generic driver for the type of printer)
· To add the printer, tap Done.
After the new printer is added, the printer must be verified before it is available to print a report or
document.

Configuration
Verify Printer Details
To Verify a Printer:
¥ Note: The Configure command can be configured as an icon on the menu

bar and thereby is removed from the System menu.
2. On the General tab of the Configure screen, tap Printers.
3. In the list on the Printers screen, tap a printer.
4. Tap Verify Printer.
5. Under Report Selection in the Printer Verification flyout, tap Printer Verification Report.
6. Tap Print.
7. Compare the printed report to the report that is displayed in the Printer Verification flyout.
¥ Note: The printed report and the displayed report must contain the same
information. Be sure that the two reports do not contain truncations,
missing or cutoff boarders, or any loss of information. If the two reports
do not contain the same information, the printer is not verified.
¥ Note: To adjust the size of the text in the displayed report, tap the Text
Size button.
8. Tap Done.
9. When a confirmation message is displayed, tap one of the following buttons:
4 Tap Yes if the printed report and the displayed report are identical.
4 Tap No if the printed report and the displayed report are not identical.
¥ Refer to the Alinity ci-series Operations Manual Section 2 Installation

procedures and special requirements, subsection System Configuration.

Configuration
Bar Codes screen

The Bar Codes screen is used to set bar code settings:
· Enable or disable sample bar code types.

· Configure checksums.
· Configure transmission of checksum digits to the user interface (UI) computer.
· Configure transmission of start and stop characters to the UI computer.
· Configure primary and secondary code lengths.

Configuration
Reagents and Supplies screen

The Reagents and Supplies screen is used to configure reagent options, diluent options, and supply
low alerts.
The settings are:
· Reagent low alert settings for individual reagents, onboard solutions, and bulk solutions
· Reagent expiration and stability override
· Run controls by reagent lot or reagent kit
· Run calibrators by reagent lot or reagent kit
· Define which module in a multimodule system uses Detergent B (c- series)
· Print 1D Bar codes for user defined reagents and diluents
Print 1D Bar Code
For more information, including the procedure to print a 1D reagent bar code report, refer to the
Alinity ci-series Operations Manual Section 5 Operating Instructions, subsection Reagent and sample
management, Print a 1D reagent bar code report (c-series).
When labels are printed the system software provides the following Avery label templates:
4 5520
4 L4773
4 L7060
Correct Placement of the 1D reagent bar code label

Configuration
· Orientation: With the handle of the reagent cartridge facing to the right side of the cartridge,
the label can be affixed to the R1 reagent bottle. The R1 reagent bottle is the larger bottle and is
positioned leftmost in the cartridge. The printed bars of the label must be vertically oriented.
· Placement: The top edge of the label must be aligned with the cartridge transport tab. The left
edge of the label must be aligned with the left edge of the R1 reagent bottle.
· Vertical angle: The vertical angle of the label must be +/- 5 degrees. When the label is not as
vertically straight as possible, the bar code reader may not locate the required quiet zones and the
start and stop characters.
1D reagent bar code label data format
Digit 1 to 6
· Reagent name: A unique six-digit alphanumeric entry is assigned to the reagent
¥ Note: The reagent name (digits 1 to 6) of the 1D reagent bar code label
must be identified to the name of the corresponding user-defined reagent
Digit 7 to 10
· Serial number: A four-digit numeric entry identifies the unique serial number of the reagent
cartridge.
¥ Note: Each cartridge in one lot of reagent must have a unique numeric
identifier.
Digit 11 to 15
· Lot number: A five-digit alphanumeric entry identifies the unique lot number of the reagent
cartridge.
¥ Note: The system software creates lot and serial number data for reagent
cartridge from digits 1 through 6 of the reagent name, digits 11 through
13 of the reagent lot number, and digits 7 through 10 of the reagent serial
number. In the system software, alpha characters that are used in lot
numbers are not case sensitive.

Configuration
Digit 16
· Expiration year: The one-digit entry identifies the year that the reagent expires.
· Range 0-9
· The selection represents the last digit of the year. The range is then interpreted as 1 year before
the selection and 8 years in the future. For example, if the current year is 2003, the following
information is applicable:
4 A bar code entry of 3 represents an expiration year of 2003.
4 A bar code entry of 2 represents an expiration year of 2002
4 A bar code entry of 1 represents an expiration year of 2011.
Digit 17 to 18
· Expiration week: The two-digit numeric entry identifies the day of the week the reagent expires.
· Range 00-52
· Examples:
4 00-Expires at the end of the 7th day of the year
4 52-Expires at the end of the last day of the year
¥ Note: If a value greater than 52 is entered, the reagent expiration is not

tracked.
Reagent Cartridge Fill Volumes
The R1 bottle can have a maximum volume of 74ml and the R2 47ml. 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 and lead to damage of the reagent carousel.
¥ For further information on fill volumes based on cartridge type and item
type, see the Alinity ci-series Operations Manual Section 5 Operating
Instructions; Prepare sample diluents and user-defined reagents (c-series)

Configuration
Reports screen
The reports screen is used to configure settings and options for automatically generated reports.
The operator can view settings and can configure print screen output options.
The print screen output option determines if a print screen goes to a printer or to a USB when you tap
the blue Abbott A in the upper right hand corner of the screen.
The supervisor can configure settings for automatically generated reports.
The system administrator can configure a facility name to display on each report.

Configuration
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On the Abbott Mail screen, the operator can view the Abbott Mail download options.
The system administrator can perform the following functions:
· Enable or disable Abbott Mail items that can be downloaded automatically.

· Configure the download language for the Abbott Mail documentation.
AbbottMail is discussed more in Abbott Tools and Resources Training Module.
¥ NOTE: If the system is a standalone i-series Calibrator Data will not be

an option.
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1. Locate the procedure in the online Operations Manual.
2. Review the features of the General Tab.
3. Create a new user.
4. Turn on print Calibration Details Report.
5. Change number of priority positions to 5.
6. Turn ON override reagent stability.

Configuration
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' ĞŶĞƌĂů^ĞƫŶŐƐ
Complete the following review questions
1. When creating a new user, a PIN is required.
a. True
b. False
2. What are the four options that can be automatically down-loaded for Abbottlink (if standalone IA
will only be three)?
a. Assay files, Assay Inserts, Assay Insert Notifications, Calibrator Data
b. Assay Inserts, Calibrator Data, Users Profiles, Audio Alerts
c. Assay Insert Notifications, Assay Files, All General Settings
d. Host Setup, Query Time-Out Seconds
3. Where is the setting to automatically reposition samples for retesting located?
a. Modules, Module 1
b. Modules, Module 2
c. Modules, Module 0
4. Once you create a new user, you can delete that user profile at a later time.
a. True
b. False

Configuration
5. Where is the print screen output destination changed AND what does the print screen output
destination mean?
a. Printers: destination for a screen shot when the blue Abbott A in the header of a screen is used
b. Reports; destination for all sample and maintenance reports
c. Reports: destination for a screen shot when the blue Abbott A in the header of a screen is used
d. Printers; destination for all sample and maintenance reports
6. After you install a new printer, you must manually verify that printer or it will not show as available
when trying to print.
a. True
b. False
7. Which bar code type cannot be disabled?
a. Interleaved 2 of 5
b. Code 128
c. Code 39
d. Codabar

Configuration
8. What are the steps to print a 1D barcode for a reagent or diluent (clinical chemistry only)?
a. Printers, select printer, verify printer
b. Bar Codes, Select Code 39, Enabled
c. Reagents and Supplies, select reagent or diluent, Print 1D Bar code
d. Computer Tab, Distant Alert
9. Where can the Module Name be edited?
a. Reagents and Supplies
b. Abbott Mail
c. Users
d. Modules

Configuration
10. What information is it suggested be entered into the Module Name?
a. Name of the Facility
b. Social Security Number
c. Tech ID
d. Module Serial Number
11. What is the maximum number of positions that can be configured for each module to store
onboard QC/Cal racks?
a. One
b. Two
c. Four
d. Three

Configuration
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Create Alinity c-series Diluent 1D Bar code
1. Log on as ADMIN or Supervisor
2. Go to System > Configure> General>Reagents and Supplies.
3. Highlight Saline (or desired diluent/Open Channel Reagent).
4. Select Print 1D Bar Code.
5. Type in the following Label Options:
4 Saline
4 Lot# 12345
4 Expiration 12/24/2020 S
4 Starting Serial Number = 1234
4 Number of Labels = 10
4 Highlight Report Selection (Bar code Paper Format) = 1D 5520

Configuration
6. Select Print.
4 Print preview button

4 Put bar code label paper in printer (as needed)

Configuration
7. Select OK to acknowledge possible expiration date change.
4 The bar codes will print and are able to be placed on reagent cartridges as needed.

Configuration
Computer Tab
There are several screens that can be accessed from the Computer tab including:
1. General Settings.
2. Audio Settings.
3. Host Setup.
4. HL7 Communication.
5. ASTM Communication.
6. LAS Communication.
7. Shortcuts.
8. Automatic Backup.
9. Alinity PRO.
10. AbbottLink.
11. Distance Alert.

Configuration
Unless otherwise specified, System administrator access is needed to perform the configuration.
The operator can view the settings.

-Setup>Configure computer settings>Automatic Backup>Configure an

automatic backup.

Configuration
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The General settings screen is used to:
· 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.
After changing the Date/Time Zone or the System Language, the UI computer shuts down and
restarts.
The operator can configure the speaker volume.

Configuration
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The supervisor can use the Audio Settings screen to configure audio settings for the system:
· 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.

Configuration
Host Setup screen

The Host Setup screen is used to set the interface, transmission, and result release settings.
· 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.

Configuration
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The HL7 Communication screen is used to configure the host communications settings for the system.
· Configure message headers.

· Configure sender channels.
· Test HL7 communication settings.

Configuration
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The ASTM Communication screen displays a single TCP/IP communication channel to send
and receive messages to and from an ASTM host. The screen is used to open a connection to the
configured port and IP address for the ASTM host channel when the proper conditions are met.
· Configure the IP address and the port number.

· Configure the character encoding setting.
· Test the ASTM channel settings.
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The LAS Communication screen displays LAS settings for the system.
On the LAS Communication screen, the operator can view the following information:
· Laboratory automation system (LAS) configuration options

· Sender channel settings
· Receiver channel setting
The system administrator can configure sender channel settings.
The LAS Communication screen displays the laboratory automation system (LAS) settings for the
system.
· Configure LAS communication settings

Configuration
Shortcuts
The system administrator can configure two shortcuts as icons on the menu bar.

Configuration
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On the Automatic Backup screen, the operator can enable system automatic backups.
When the Automatically Perform Backup check box is selected, seven daily automatic backups and
four weekly automatic backups are saved on the hard drive and/or a USB flash drive.
The system administrator can enable or disable the automatic backup and can configure the
automatic backup options.
¥ Note: The system must be in any status beside Processing or Pausing

for the backup to complete successfully. If the backup is not completed, a
notification will be generated.

Configuration
Alinity PRO Screen

Alinity PRO is a data- sharing software application between Alinity systems and the Alinity PRO
computer.
Alinity PRO is discussed more in Abbott Tools and Resources Training Module.
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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.

Configuration
Distance Alert
On the Distance Alert screen, the system administrator can perform the following functions:
Enable or disable the distance alert.
Enable or disable distance alert functionality for notifications.
4 Exceptions
4 Quality Control
4 Calibration
4 Reagents
4 Supplies
4 Procedures
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2. Review the features of the Computer Tab.
3. Configure an automatic backup.
4. Change audio setting for notifications. Select Sound 08.
5. Change Shortcuts to icon of your choice.

Configuration
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ŽŵƉƵƚĞƌ^ĞƫŶŐƐ
Complete the following review questions
1. You can enable the distance alert to change color if an exception is generated.
a. True
b. False
2. Where can the requirement for a general operator log-on to require a PIN be disabled?
a. Audio Alerts, Turn off All Audio Alerts
b. General Settings, Required Authentication for General Operator
c. Host Setup, Query Time-Out Seconds
d. Shortcuts, Final Shortcut
3. What is the maximum number of shortcuts that are editable?
a. One
b. Two
c. Three
d. Four

Configuration
4. If you have not configured the ASTM or HL7 settings, they will not be active options on the host
setup screen.
a. True
b. False
5. What are the three different audio alerts that can be configured?
a. Critical, Alert and Notification
b. Critical, Alert and Exceptions
c. Critical, Notification and Exceptions
6. What status must the system be in for an automatic backup to complete?
a. Any status except Offline and Stopped
b. Any status except Processing or Pausing
c. Any status except Initializing and Warming
d. Any status except Running or Maintenance

Configuration
7. What happens if the instrument is not in the correct status to perform an automatic backup?
a. An Overdue Maintenance Procedure will be scheduled as a reminder
b. Nothing
c. The backup will not complete and a notification will be generated
8. Where can Disable Sample Processing When Maintenance Is Overdue be turned on?
a. Computer Tab, Abbottlink
b. Computer Tab, General Settings
c. Computer Tab, Distance Alert
d. Computer Tab, Alinity PRO

Configuration
Assay Tab
Screens that can be accessed from the Assay tab:
1. Assay Parameters.
2. Calibrator Set.
3. Install/Uninstall Assays.
4. Import/Export Assays
5. Assay Display Order.
6. Panel Definition.
7. Cal/QC Ordering.
8. Quality Control.
9. Westgard.
The operator can view the settings

Configuration

-Setup>Configure assay settings>Calibrator Set>Create a new calibrator

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

calibrator lot
-Setup>Configure assay settings>Calibrator Set>Import calibrator data

(c-series)
-Setup>Configure assay settings>Install/Uninstall Assays>Install assay

files
-Setup>Configure assay settings>Quality control>Manually create a new

quality control lot
-Setup>Configure assay settings>Quality control>Import quality control

data.

Configuration
Assay Parameters
The Assay Parameters screen is used to:
· Edit general assay settings.

· Edit calibration settings.
· Edit result and interpretation information.
· Configure assay retest rules.
· Configure SmartWash settings.
· Create a user-defined or calculated assay
· Assay Parameters c-series:
4 General tab
4 Calibration tab
4 Results tab
4 Retest Rules tab
4 Smartwash tab
· Assay Parameters i-series:
4 General tab
4 Calibration tab
4 Results tab
4 Retest Rules tab.
Calibrator Set
The Calibrator Set screen is used by the supervisor and system administrator to:
· Manually create new calibrator master lot or import calibrator data to create new calibrator lot.
· Edit calibrator data.
· Delete calibrator lots.
The system administrator can delete imported calibrator data.
Create a new calibrator master lot
Create a new calibrator master lot for an existing calibrator set by scanning the bar code on the
calibrator carton.
· The system automatically creates a new calibrator master lot with the master lot number and
expiration date from the bar code on the calibrator carton.
· The first configured master lot number is designated automatically as the default master lot number.
· The default master lot number can be changed when the instrument status is Running or Processing
if no orders are pending for the calibrator set.

Configuration
· The data must be defined for all assays and all levels of the default master lot.
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 master lot number is designated automatically as the default lot number.
· The default master 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 master lot number, the data must be defined.
· Imported calibrator data is retained on the system for a time period of 6 months past the calibrator
expiration date. After the time period has elapsed, the system automatically deletes the imported
calibrator data.
· Calibrator data files that are imported from a USB flash drive are saved to an internal storage
location on the system. To reinstall the calibrator data files on a future date, tap the Hard Drive
button.

Configuration
Install/Uninstall Assay Files

The Install/Uninstall Assays screen is used to:
· Install assays.
· Uninstall assays.
· Delete assays on the hard drive.

Configuration
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 www.corelaboratory.abbott and
saved to a USB flash drive.
Abbott mail will be discussed in another module later in this training.
Import/Export Assays screen

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

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.

Configuration
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The Panels Definition screen is used to:
· Configure new panels for specimens, QC, and calibrations.

· Edit an existing panel.
· Delete a panel.
Cal/QC Ordering screen

The Cal/QC Ordering screen displays the calibration and quality control settings. It is used to
configure,
· Ability to override expired calibrations.

· Ability to override calibrator lot expiration.
· Ability to override control lot expiration.
· Ability to disable a reagent when a control fails.
· Ability to require quality control to run after a calibration is generated.
¥ Note: If calibrators will be used for onboard storage and automatic

calibrations, it is recommended this setting be turned on.
· Whether the control expiration date must be entered before an order is created.

Configuration
Quality Control screen

The Quality Control screen displays the quality controls that are configured. It is used to:
· Configure multi-constituent and single-constituent controls.

· Edit multi-constituent and single-constituent controls.
· Import control data.
· Delete a quality control.

Configuration
Manually create a new control lot

· Manually create a new single-constituent or multi-constituent control lot.
· The control name can have from 1 through 10 characters and a control lot number can have from 3
to 9 characters.
Facilitator to review the relationship between the Automated selection of Yes or

No, and the Time Interval (Minutes) box.
Import quality control data
If a control product has separate c-series and i-series data files, both data files must be imported on
the Alinity ci-series.
· 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 are imported for assays that have a status of OK.
· No data is imported for assays with the following statuses:
4 No Assay.
4 Previously Defined.
4 Units Mismatch.
4 Version Mismatch.
These statuses are displayed in red text.

Configuration
The first configured lot number is designated automatically as the default lot number for control
orders.
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.

Configuration
Westgard screen
The Westgard screen displays the Westgard rule configuration settings for the assays installed on the
system.
The supervisor or system administrator can configure Westgard rule settings for each assay
installed on the system.
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Install an assay file
2. Review the features of the Assays Tab.
3. Install an assay file designated by your facilitator.

Configuration
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provided by instructor)
2. Create a new control lot.
3. Import a new c-series calibrator master lot.
4. Create a new i-series calibrator master lot.
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Complete the following review questions:
1. All assays including i-series (with the exception of enzymes), require an active calibrator set.
a. True
b. False
2. What is the definition of onboard stability and in-use stability for control or calibrator vials? (Select
all that apply)
a. In-use stability tracks the time the vials are being mixed
b. Onboard stability tracks the time when the vials are stored in the reagent carousel
c. In-use stability tracks the time those vials are outside of the reagent carousel and being sampled
d. Onboard stability is the time vials are open on the counter top

Configuration
3. Panels can be defined for which three order screens? (Select all that apply)
a. Specimen
b. Control
c. Calibrator
d. Assay Parameters
e. Reagents
4. If the setting for an Automated control that is stored onboard is turned on, which field must have a
value entered into it?
a. Default Dilution
b. On-board stability
c. Expected Mean
5. Where can Control Required After Calibration be turned on?
a. Quality Control
b. Assay Display Order
c. Cal/QC Ordering screen
6. It is recommended to that Control Required After Calibration be turned on if using automated

calibration via on-board racks in the reagent carousel.
a. True
b. False

Configuration
7. Where are the two locations that a list of installed assays (Assay information report) be printed?
a. Install/Uninstall Assay Screen, installed files tab
b. Assay Parameters Screen
c. Supplies Status Screen
d. Panel Definition Screen
8. Results units are changed via a drop-down box and if changed, linearity and QC values will be
changed as well.
a. True
b. False

Configuration
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There are two screens that can be accessed from the Maintenance & Diagnostics tab:
1. Install/Uninstall M&Ds.
2. User-Defined Maintenance.
The operator can view the settings.

Configuration
Install/Uninstall Procedures screen

The Install/Uninstall Procedures screen is used to:
· Install maintenance and diagnostic procedures.

· Uninstall maintenance and diagnostic procedures
The Available Files tab displays all procedure files that are available for installation on the system or
on a USB flash drive.

Configuration
User-Defined Maintenance screen

On the User-Defined Maintenance screen is used by the supervisor and system administrator to:
· Create a text-based maintenance procedure.

· Print a procedure.
· Uninstall a procedure.
· Export a procedure.
Create a user-defined maintenance procedure
The Create/Edit tab displays the user-defined procedures that are editable and allows the operator
to create new user-defined procedures.

¥ To locate the procedures using online Procedure Map refer to the

-Setup>Configure maintenance and diagnostics settings>User-Defined

Maintenance>Create a user-defined maintenance procedure.

Configuration
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Create a user-defined maintenance procedure
2. Review the features of the Maintenance and Diagnostics Tab.
3. Create a user-defined maintenance procedure as defined by your facilitator.
4. Delete procedure created in step 3

Configuration
Review
1. Eight daily automatic backups and four weekly automatic backups can be saved on the hard drive
and/or a USB flash drive.
a. True
b. False
2. Which one of the following is true of assay file installation?
a. You need to review the specific information for each assay before installation. Assays may have
specific installation requirements.
b. Assay files that are installed from a USB flash drive are deleted and cannot be recovered.
c. You do not need to refer to the assay-specific installation information for specific calibration and
quality control requirements.
d. The required instrument status is Running.

Configuration
3. You create a new calibrator master lot for an existing calibrator set by scanning the bar code on the
calibrator carton.
a. True
b. False
4. Which of the following tasks are performed from the General Tab on the Configuration screen?
a. Add a printer
b. Configure system date and time settings
c. Create and edit users
d. Uninstall maintenance and diagnostics procedures
e. Configure reagent and supply low alerts

15 h ƟůŝƟĞƐ
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Module Topics
Utilities provide tools that the Alinity system software can use to help meet the needs of the
laboratory.
In this module, you will explore the:
· Utilities screen
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After completing this module, you should be able to perform tasks from the:
o Backup/Restore screen
o System Updates screen
o Troubleshooting screen

are:
Section 2 Installation procedures and special requirements subsection;

Utilities screen

Utilities
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The Utilities screen can be accessed from the System button on the Home screen.
The following tasks are performed from the Utilities screen:
Backup/Restore
· Perform a backup.
· Copy a backup to a USB flash drive.
A backup can be restored with Abbott assistance.
System Updates (performed by a

system administrator)
· Download system updates.
· Install and verify system updates.
· Decline non-mandatory system updates.
The operator can print system update documentation.
dƌŽƵďůĞƐŚŽŽƟŶŐ
Retrieve system log packages.

Utilities
Current Firmware
View the current firmware for i-series processing module, reagent and sample manager, and pressure
monitor board for the c-series processing module when requested by an Abbott Laboratories
representative.
Licenses
View or print the Licenses Report.
Backup/Restore, System Updates and Trouble-

ƐŚŽŽƟŶŐ
Backup/Restore screen
To access the Backup/Restore screen,
1. On the menu bar, tap System, and then tap Utilities.
2. On the Utilities screen, tap Backup/Restore.
A manual backup should be performed:
· After a software update is downloaded.

· A new assay file is downloaded.
· The system configuration is changed.
A total of three manual backups can be saved on the hard drive. The fourth time you create a backup,
the system removes the backup with the oldest date and replaces it with the new backup.
The following function buttons are present on the Backup/Restore screen:
· Utilities - Displays the Utilities screen.

· Create Backup - Displays the Backup flyout.
· Copy - Displays the Copy Backup flyout.
In the Backup flyout, the operator can enter a comment and save a backup on the hard drive. You can
also save a backup on the hard drive and a copy of the backup on a USB flash drive.

Utilities
Using USB Flash Drive for Backup
The USB flash drive should have a minimum of 2GB of space. Do not use a USB flash drive that is
software encrypted with password protection.
The Copy Backup flyout displays the drive and folders that are used to save a backup copy. It is used
to copy a backup from the system to a USB flash drive.
The Instrument status can be any status except Processing and Pausing to perform the manual backup
procedure.
The following items are saved in the backup:
· System calibration data (for example, robotics data and optics data)
· User-defined maintenance procedures
· The system database, which includes the following items:
4 System configuration settings (for example, host settings, report settings, system serial number,
and system name)
4 Reagent cartridge test counts
4 Assay configuration settings
4 Assay calibration data
4 Control configuration
4 Control results Specimen results
4 Installed maintenance and diagnostic procedures and the maintenance and diagnostic procedure
history
4 Supply data
4 Assay inserts
4 Abbott Mail items
System Updates screen

To access the System Updates screen,
2. On the Utilities screen, tap System Updates.
Occasional software and hardware updates may be received that need to be installed manually.
The System Updates screen displays system updates that are available for installation, system
updates that are installed, and system updates that have been declined.
The System Updates screen has 11 system update statuses:

Utilities
Status Description
Available The software installer for a system update is available to download.
Download A request to download the system software installer is in process.
Requested
Download Failed An error occurred and the request was not completed.
Ready to Install The system software installer is present and is ready to install.
Install in Progress The installation is in process.
Install Failed An error occurred and the installation was not completed.
Pending The installation of the system update was successful, but a manual
Validation verification by the operator is required.
Applied The installation of the system update is completed.
Manually Applied The system update was completed after a manual verification or by an
Abbott Laboratories representative.
Superseded The system update was superseded by a different system update.
Ignored The system update was declined and was not installed.
Screen Elements include:

· Mandatory - Displays if the system update is mandatory and must be installed.
· Requires System Restart - Displays if the software needs to be restarted after the TSB is
installed.
· Requires Verification - Displays if the TSB requires a manual verification after the installation is
completed.
· Prerequisite Update - Displays a list of TSB numbers that must be installed before the TSB that
is displayed is installed.
Function buttons include import, print, download, install, decline, and add a comment.
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.

Utilities
s ŝĞǁ ŽƌWƌŝŶƚ^ǇƐƚĞŵh ƉĚĂƚĞ ŽĐƵŵĞŶƚĂƟŽŶ

2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin (TSB)
number in the TSB list
4. Tap Print.
5. Under Report Selection in the Print flyout, tap System Update Letter.
6. To rotate the document, use the Rotate tool bar.
7. To browse the document, use the Page tool bar.
8. To increase or decrease the font size in the document, use the Zoom tool bar.
9. To resize the document to fit the window width or to resize the document to fit one full page in the
window, use the Fit tool bar.
10. To find a word or phrase in the document, use the Find tool bar.
11. To print the document, tap Print.
To return to the System Updates screen, tap Done.
On the System Update Import screen, the operator can import a translated version of the
operations manual.

Utilities
dƌŽƵďůĞƐŚŽŽƟŶŐƐĐƌĞĞŶ
To access the Troubleshooting screen,
2. On the Utilities screen, tap Troubleshooting.
On the Troubleshooting screen, the operator can retrieve system log packages that can be used for
troubleshooting by an Abbott Laboratories representative.
All troubleshooting packages can be retrieved when the instrument status is Idle.
Troubleshooting package information contains system logs and data that is used by an Abbott
Laboratories representative to troubleshoot instrument and assay issues.
Troubleshooting packages can be sent to AbbottLink or saved to a USB Drive.
The following list provides descriptions of the troubleshooting packages:
Troubleshooting
Description
Package
Core Operational Includes core operational data (for example, result data, calibration data,
Data and instrument operational data) that is located in the operational data
recorder (ODR) of the instrument.
Instrument Logs Includes instrument logs.
External Includes all communication logs with external systems (for example, HL7
Communication Logs and ASTM host communication logs).

Utilities
¥ To locate information and procedures related to the Utilities screen

refer to the Alinity ci-series Operations Manual Section 2 Installation
procedures and special requirement
-Troubleshooting>Back up and restore>Perform a manual backup
-Setup>System updates>View or print system update documentation
-Setup>System updates>Download the system update software
-Setup>System updates>Install a system update
-Troubleshooting>Log retrieval>Retrieve a troubleshooting package
ĐƟǀ ŝƚǇϭ
Perform a manual backup
2. Then perform a manual backup.
ĐƟǀ ŝƚǇϮ
dƌŽƵďůĞƐŚŽŽƟŶŐƐĐƌĞĞŶ
1. View the Troubleshooting screen.
2. Identify the function that the operator can perform on this screen.
3. Retrieve a troubleshooting package

Utilities
Review
1. Select the tasks that can be performed on the Utilities screen.
a. Backup/Restore
b. Log on
c. System Updates
d. Troubleshooting
e. Maintenance
f. View the current firmware
2. The Copy Backup flyout allows you to enter a comment for a backup.
a. True
b. False
3. Which one of the following statements is true for the system software update installation.
a. The system update status must be Declined before software installation.
b. The operator access level for this procedure is not necessarily dependent on the system update
being performed.
c. You need to download the software installer for a system update (or a previous software installer
download that failed) before you can begin installation.

Utilities
4. TSBs are tracked on the Troubleshooting screen.
a. True
b. False
5. Select all of the files that are collected in the Core Operational Data troubleshooting package.
a. Reagent and sample manager log data
b. Assay activity data
c. Result data
d. Calibration data
6. Before you install a system software update, you need to download the system update software.
a. True
b. False

16 ďďŽƩdŽŽůƐĂŶĚZĞƐŽƵƌĐĞƐ
ϯ ϬŵŝŶƵƚĞƐ
Module Topics
Familiarize yourself with the features of Alinity ci-series. In this module, you will explore:
· Abbott Mail
· AbbottLink
K ďũĞĐƟǀ ĞƐ
o Describe and perform tasks from the Abbott Mail Inbox screen
o Describe the function of AbbottLink

are:
Section 5 Operating Instructions subsections; Home screen

Abbott Tools and Resources
Tools and Resources

ďďŽƩD Ăŝů
Abbott Mail is a resource available through the Home menu on the SCM. Abbott can send updated
package insert information and other documentation and notices. It is recommended that you check
Abbott Mail frequently to stay up-to-date.
Abbott Mail is only available with systems connected to AbbottLink. Contact your Abbott
Representative for more information or have your system connected to AbbottLink.
In the AbbottLink Connection Status flyout (accessed from the AbbottLink button on the System
Status bar), the operator can view the status of the AbbottLink connection and can restart AbbottLink.
The AbbottMail Box can be access from the Systems button on the Home screen.
On the Abbott Mail Inbox screen, the operator can view Abbott Mail items and Abbott Mail
documentation.
There are five functions the system administrator can perform are:
1. Accept Abbott Mail items
2. Delete Abbott Mail items
3. Request assay files

4. Request calibration data files
5. Decline system updates
The Abbott Mail inbox screen has the following tabs which also displays if the mail is new or is an
update and if it has been previously viewed.
· All tab
· Assay Files tab
· Assay Inserts tab
· System Updates tab
· Calibrator Data tab
Manual File Request screen
On the Manual File Request screen, the operator can view manual requests for assay files and clinical
chemistry assay calibrator data.
The screen displays one pending request and the last five completed requests.
The system administrator can use an AbbottLink connection to request manually the assay files to
send to the system software.
Access the Manual File Request screen by selecting the Request (All tab), Request Assay (Assay
inserts tab), or Request Calibrator (Calibrator data tab) function button.
Only one active request, regardless of the Abbott Mail type, can be performed at a time.
¥ To locate information and procedures related to Abbottmail refer to the

-Setup>Abbott Mail>Manually request calibrator data files
-Setup>Abbott Mail>Manually request assay files

My Lab Customer Portal

At the www.corelaboratory.abbott website, the My Lab Customer Portal provides access to
technical documents, timely communications, useful links and other resources needed in the lab with
self-service capability.
Why Register?
Gain access to technical information for Abbott Diagnostics products, personalized support, and
other useful tools available only to customers.
Registration is easy!
Provide your name, e-mail address and an instrument serial number to complete the process and
activate your account.
ĐƟǀ ŝƚǇϭ
ďďŽƩD Ăŝů/ŶďŽǆƐĐƌĞĞŶ
1. Access the Mail Inbox screen.
2. View all the Tabs.
ĐƟǀ ŝƚǇϮ
Manually request assay files
2. Perform the procedure to Manually request assay files.
3. Identify the category that was requested.

ĐƟǀ ŝƚǇϯ
Manually request calibrator data files
2. Perform the procedure Manually request calibrator data files.
3. Identify the calibrator data file that was requested.
Alinity PRO
Alinity PRO is a data-sharing software application between Alinity systems and the Alinity PRO
computer. The Alinity PRO software maximizes the potential of your Alinity systems to enhance
operational productivity throughout your network, allowing for easier and consolidated system
monitoring.
· Alinity PRO provides the following options and features:

· Operate flexibly – As a web-based software, there is no need to install Alinity PRO at each user
workstation. You can access the software through any supported browser.
· Inventory sharing allows the laboratory to share reagents, calibrators, and controls between
different instruments that are controlled by a different user interface computer.
· Monitor systems anytime, anywhere – Alinity PRO allows you to connect to an unlimited number
of Alinity systems from across your entire network. And you can access Alinity PRO from any PC
workstation in your network, regardless of its location — or yours.
· 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
· Interact intuitively – Alinity PRO logically organizes information by type or by a specific group of
analyzers. And because Alinity PRO shares the same interface design as Alinity system software,
operation is consistent and easy-to-use.
MAXIMIZE UPTIME WITH “PLAN MY DAY” CHECKLISTS
Proactively identify key activities from a consolidated checklist across your Alinity ci-series and
Alinity s systems to minimize interruptions. Alinity PRO allows you to view upcoming tasks required
to keep Alinity systems operating, such as those related to inventory, maintenance and calibration.
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.

To configure Alinity PRO settings for the system:
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap Alinity PRO

Review
1. Select the tasks an administrator can perform on the Abbott Mail Inbox screen: (select all that
apply)
a. Decline system updates
b. Request calibrator data files
c. Delete Abbott Mail items
d. Accept Abbott Mail items
e. Request assay files
2. When manually requesting calibrator data files, multiple active requests can be performed at a
time.
a. True
b. False
3. Select the following tasks an administrator can perform on the Manual File Request screen. (Select
all that apply)
a. View the pending manual request
b. Manually request calibrator data files via Abbottlink
c. View the last five completed manual requests
4. Abbott Mail is only available with systems connected to Abbottlink.
a. True
b. False

Appendix
Appendix A: Lab Activities

Your facilitator may assign any of the following laboratory practice activities during your training.
Activity 1: Update Supplies and Daily Maintenance
Activity 2: Run Calibrations and QC
Activity 3: Patient Run and Troubleshooting
ĐƟǀ ŝƚǇϭ͗ h ƉĚĂƚĞ^ƵƉƉůŝĞƐĂŶĚ ĂŝůǇD ĂŝŶƚĞŶĂŶĐĞ

1. Check supplies:
4 Prepare and load consumables.

4 Empty/add/update in software, as required.
2. Check reagent status:
4 Load reagents, as needed:

4 Resolve errors and scan to verify all issues are resolved
3. Perform Daily Maintenance:
ĐƟǀ ŝƚǇϮ͗ ZƵŶĂůŝďƌĂƟŽŶƐĂŶĚY

1. Put RSM and both PMs into Running status:
2. Check Cal status and calibrate, as needed:
3. Run QC:
App-1 Alinity ci -series Global Customer Training | ADD-00066223

Appendix
ĐƟǀ ŝƚǇϯ ͗ WĂƟĞŶƚZƵŶĂŶĚdƌŽƵďůĞƐŚŽŽƟŶŐ

1. Place RSM and both PMs in Running status:
2. Check calibration status:
3. Order calibrations, as needed:
4. Load bar coded QC:
5. Order and run patient samples, as directed:
6. Complete activities on your own:
7. Troubleshoot issues as they occur:
8. Use the following for assistance:
4 Alert Center
4 Operations Manual
4 Facilitator

Appendix
ƉƉĞŶĚŝǆ͗ WĂƟĞŶƚZƵŶƐ
Your facilitator may have you use any of the patient information tables contained in this appendix to
practice manual patient run activities during your training.
ĐƟǀ ŝƚǇϭ
SID Assays Patient Details Assay Options
404 Ima Chem6, Trig, Cowgirl
Fertility
PID: 333-22-4444
345 Crea, AST, Trig, Honey Bee
TP, Estradiol
ER Room 1
653 ICT, Glu, TP, Daffy Dill
B-hCG
313 AST, TSH Herb Garden TSH 1:5 auto dilution
654 Trig, GluC, H, I, Jean Poole
Fertility PID: 2000-2222

322 Chem6, TSH Ivy League
987 ICT, Crea Katy Didd Creat manual 1:2 dilution
(ICTs should not be diluted)
678 ICT, TP Sandy Beach
474 Glu, Crea, TSH Teri Daktul Glu 1 replicated undiluted and
1 replicate autodiluted Crea 2
replicated undiluted
272 Trig, ICT, TSH Rollin Pin
Alinity ci -series Global Customer Training | ADD-00066223 App-3

Appendix
ĐƟǀ ŝƚǇϮ
After daily startup, updating supplies and Daily Maintenance, run QC for IA Plus and Chem.

110 B-hCG, HIV Mander, Sally 2 replicates of Glu
Ag/Ab, ICT, Glu
PID: 1234567
DOB = 03/17/60
120 TSH, Glu, AST, Zuma, Monte
TP, Alb
PID: A456
130 TSH, Estradiol, Monk, Chip
Chem6
PID: NUTS
140 B-hCG, TP, Alb, Pease, Warren
Trig
PID: 1998
Icteric
150 Estradiol, TSH, Mander, Jerry 5 replicates on TSH
Glu, Trig
PID: ABCD
160 B-hCG, Liver, Ringing, Isabelle Lipemic B-hCG (1:15 dilution and
TP undiluted)
170 TSH, Fertility, Evore, Herb Crea 1:2 dilution
Crea
PID: 5557777
180 HIV Ag/Ab, Fish, Golda
TSH, Glu, TP,
Alb
190 TSH, ICT, AST Lergy, Al
200 Estradiol, Geste, Shirley U.
Chem6, TP, Alb
PID: 6945320
Hemolyzed

Appendix
ĐƟǀ ŝƚǇϯ
1. Calibrate, as required.
2. Order appropriate controls.
3. Order patient samples listed in table below:

100 TSH, ICT, Crea John Lee Smith
PID: 707341
DOB =03/17/60
300 B-hCG, Estradiol, Chem6, Martha May 2 replicates of Estradiol
TP, Alb Williams
PID: A456
500 Estradiol, ICT, Crea, Urea, Bob Smith 1:5 dilution on Glu
Glu, Trig
PID: 303030
700 HIV Ag/Ab, TSH, HIL James Kent
Panel, Chem6
Icteric
900 B-hCG, Glu, TP, Alb Wilma Jackson B-hCG 1:15 dilution
PID: 123456 5 replicates on Glu

110 HIV Ag/Ab, ICT, L, Trig Ian
Flanagan
Lipemic
111 B-hCG, TSH, Urea, Crea Heidi Schultz B-hCG manual dilution 1:2, no
Dilution on Thyroid panel
1:5 dilution on Urea

150 HIV Ag/Ab, TSH, HIL Amar Patel 1:5 dilution on Glu
Panel,
PID: 122333
Chem6, Liver, Trig

Appendix

160 Thyroid, ICT, Glu, Trig Nicholas
Phocas
180 HIV, ICT, Crea, Urea, H, Basil Moore
Estradiol PID: 700
Hemolyzed
210 Estradiol, HIV Ag/Ab, TSH Cecilia Lewis

Appendix
ƉƉĞŶĚŝǆ͗ ĚĚŝƟŽŶĂůZĞƐŽƵƌĐĞƐ
Job Aid
Take appropriate safety precautions as described in the Alinity ci-series Operations Manual prior to
performing any procedures.
Daily Maintenance
From HOME Screen Select: PROCEDURES Icon
NOTE: If Procedures is not an icon on the menu bar,
tap System, and then tap Procedures.

Appendix

Appendix
ƌĞĂƚĞĂůŝďƌĂƟŽŶK ƌĚĞƌ
· ORDERS Icon
· CREATE ORDER
OR
NOTE: The Create Order icon is a configurable icon on the menu bar.
· From Create Orders Screen:

· Select CALIBRATION Tab
4 Optional when bar- coded samples used
· Select
4 Assays
§ Type/Select Calibrator Lot
4 REAGENT SELECTION
§ Default is Auto
§ DONE
4 Select:
§ ADD ORDER
Create Control Order

· ORDERS Icon
· CREATE ORDER
OR
· Select CONTROL Tab

4 Optional when barcoded samples used

Appendix
· Select Control Data:

4 Control Name
4 Control Lot
4 Control Level
4 Assays/ Panels
§ Assay
§ Dilutions/ #
§ Replicates
§ DONE
· Select:
4 ADD ORDER
The system automatically defaults to the next level of that control product.
Create Specimen Order

· ORDERS Icon
· CREATE ORDER
OR
· Select SPECIMEN Tab

· Order Type:
4 Default Single Specimen
4 Bar-coded Batch
· At Sample Data Type:
4 SID (Sample ID)
4 Rack and Position
§ Optional with bar- coded samples
· Select Assays/Panels Comments -optional Patient Details-optional Assay Options edit - optional:
4 Dilutions Protocol
4 # Replicates
4 DONE

Appendix
· Select:
4 ADD ORDER
Load Specimens in RSM Racks
Print / View Orders

From ORDERS Screen Select:
· All Orders Tab
Use this guide to help you prepare to train basic operations of the Alinity ci-series.
To View Report:
· Select PRINT
· Select ORDER LIST
· REPORT
· DONE
To Print Report:
· Select PRINT
· Select ORDER LIST
· REPORT
· Select Print Location
· Type # copies
· PRINT
¥ Note: The steps above were created for Alinity ci-series Software version
2.6 Operations steps may vary depending on software version used. Please
refer to the current Alinity ci-series Operations Manual for additional
detail.

On the Job Basic Training Guide
Use this guide to help you prepare to train basic operations of the Alinity ci-series.
In the guide you will find Tips and Techniques for Effective Training as well as exercises and
checklists to ensure your trainee(s) feel comfortable operating the instrument and software.
Training Guide Intent

The intent of this guide is to help Trainers and Key Operators / Administrators coordinate and deliver
on-site basic operator training using the Alinity ci-series Basic Training Checklist and Alinity ci-series
Operations Manual.
ĞĮŶŝƟŽŶƐ
The goal of the training session is to provide a secondary operators with the basic knowledge needed
to operate the Alinity ci-series and make decisions independently.
Before hosting a session, check that you have a paper copy of the Alinity ci-series Training Checklist to
use along with this guide.
If you do not have a paper copy of the Training Checklist, you can get one on www.corelaboratory.
abbott or from your Abbott Representative. This form provides the written confirmation of training
that is necessary for issuance of Continuing Education credits, where available/ applicable.
This on-site training guide includes the following:
· Definition of Basic and Key Operator

· Responsibilities of Key Operators for Providing Training
· Training Topics Checklist
· General Laboratory Training Tips and Techniques
· Using the Alinity ci-series Online Operations Manual and Other
· Training Resources
· Training Activity - Checkout
Guide-1 Alinity ci -series Global Customer Training | ADD-00066223

Basic Operator Definition
A basic operator is anyone who will run the Alinity ci-series and make
decisions independently.
Key Operator Definition
The Key Operator/ Admin Operator is the primary Alinity ci-series user,
the lab or department supervisor, or an Abbott employee. This person is
responsible for training basic operators and completing all tasks listed on
the training checklist(s) and teaching them to others.
dƌĂŝŶĞƌZĞƐƉŽŶƐŝďŝůŝƟĞƐ
<ĞǇK ƉĞƌĂƚŽƌZĞƐƉŽŶƐŝďŝůŝƟĞƐ
The Key Operator / Trainer is responsible for being able to complete all tasks on the Training
Checklist and train them to others.
The Key Operator is also responsible for obtaining a paper copy of the Checklist, filling it out, and
submitting to Abbott on behalf of his/her trainees in order to obtain continuing education credits (as
applicable) for the workshop session.
· Lead the trainee(s) by asking questions, demonstrating how, and conducting reviews
· Provide feedback
· Provide required materials such as controls, calibrators, and reagents
· Fill out the paper copy of the appropriate Training Checklist as documentation of completed
training.
Training Tips and Techniques

Trainer Checklist
This form is for the trainer to do a self-assessment for the training activity. Check the items you
think you have accomplished.
· I am organized and prepared for the training.

· I am confident in the training.
· I have spoken clearly in the training.
· I am clear about the training objectives.
· I am interested in teaching my trainee about the instrument.
· I have demonstrated procedures well by following a logical sequence.

· I have directed the trainee to the tools and resources (i.e. Ops Manual).
· I have taught the trainee how to use the resources.
· I have provided enough opportunities for hands-on experience.
· I have answered all the questions from the trainee.
· From my trainee’s feedback, I am confident that he/she can operate the instrument.
' ĞŶĞƌĂů' ƵŝĚĞůŝŶĞƐĨŽƌĞƩĞƌdƌĂŝŶŝŶŐ

Ten Tips for Training Hands- On Procedures
When training a procedure, follow these general guidelines:
1. Tell the trainee why they need to perform a procedure and when to perform it.
2. Show the trainee the result of a successful procedure on the computer screen and instrument.
3. Inform your trainee of common errors when performing the procedure and how to avoid or remedy
those errors.
4. Summarize major steps of a procedure.
5. Demonstrate procedures first and then ask the learners to try.
6. Follow spatial sequence to introduce the items on the computer
screen and instrument (from top to bottom, from left to right).
7. Introduce the function of block areas first, then the details you would like to highlight for each
functional block area. Be brief and clear.
8. Direct the trainee to the resources they can use such as the Operations Manual and this online
training guide.
9. Ask the trainee if he/she has any questions, and provide answers.
10. Learn the instrument by doing. Always ask your trainee to perform the procedure after you
demonstrate it.
Alinity ci -series Global Customer Training | ADD-00066223 Guide-3

About Adult Learning
Understanding how adults learn will help you provide effective and efficient transfer of knowledge
and skills.
Check your knowledge of adult education / learning processes via taking the assessment below.
Basic Training Checklist

Completion of the Alinity ci-series training checklist indicates that the trainee has successfully
trained on the topics indicated. The paper version of this document can be used as documentation of
continuing education if submitted to Abbott.

Using the On-line

K ƉĞƌĂƟŽŶƐD ĂŶƵĂů
Directions for all procedures are included in the Operations Manual contained within the Alinity ci-
series system software. Many maintenance procedures also contain a helpful video
Learning to use the operations manual helps to save time, avert trouble, and confidently operate the
system.
The online documentation is designed to provide the fastest, easiest, and most accurate resource for
your informational needs. The online operations manual includes complete instructions for using and
maintaining an Alinity ci-series System.
The Alinity ci-series Operations Manual should be utilized as a resource during training. Before you
conduct training familiarize yourself with the general navigational features of the online manual as
described within this section of the Trainer’s Guide.
To access the 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.
Procedure Map
The procedure map is an image map that displays categories of laboratory-related activities and
provides links to lists of tasks and procedures. It is used to quickly access step-by-step instructions to
help perform primary laboratory procedures.
Procedure Map Task Lists
Task lists are topics that are accessed from the procedure map. Each topic contains an expandable list
of tasks that are related to a procedure map category or a laboratory-related activity. Each task has a
list of links to related procedures.
Search for a term
Perform this procedure to search the operations manual.
1. On the toolbar, tap the Search box.
2. With the virtual keyboard, type a search term.
3. Tap the Search icon .

4. In the list of search results on the Search tab, tap a topic title.
In the topic pane, each word of the search term is highlighted in the topic because each word of the
search term is treated individually. If only one word of a search term is in a topic, the topic is included
in the search results.
dƌĂŝŶŝŶŐĐƟǀ ŝƚǇͲŚĞĐŬŽƵƚ
This training activity should be used in conjunction with the Alinity ci-series Operations Manual. Also
be sure to download a paper copy of the checklist by visiting your Customer Portal / Other Reference
Documents / Training Checklists. After signing off your trainee, fill out the bottom portion and return
to Abbott for issuance of Continuing Education (CE) credits (US only).
This activity is designed to be performed independently by the operator/trainee. It will demonstrate

their proficiency at locating information in the System Operations Manual and performing essential
basic operator tasks.
h ƐŝŶŐƚŚĞƉƌŽĐĞĚƵƌĞƐůŽĐĂƚĞĚŝŶƚŚĞK ƉĞƌĂƟŽŶƐD ĂŶƵĂů͕ƉĞƌĨŽƌŵƚŚĞĨŽůůŽǁ ŝŶŐƚĂƐŬƐ͘
Perform the following:
· Log on with ADMIN password

· Check Reagent and Supply inventory and update, if necessary
· Perform Daily Maintenance
· Run all QC and verify the results are within acceptable range:
4 Review results
4 Re-run any unacceptable results
4 Print a copy of the QC results
· Run 1-5 specimens:
4 Review results
4 Print a Sample report for each patient
4 Remedy and re-run any Exceptions
4 Locate a specimen from yesterday’s run
Demonstrate the following:
· Access the following:

· Download Printed Checklist from Customer Portal
· Training notes
· Run a specimen using Replicates and/or Dilutions
· Manually transmit results to LIS
· Order and run an assay calibration
· Access the calibration data for one assay

· Print a Calibration Report

· Print a Levey-Jennings Graph
· View Pending Orders
Access the following:
· Maintenance Log
· Assay Parameter File for any assay
· Configuration screen, Assay Tab to enter a new lot of QC
· Online System Operations Manual
· System Backup screen
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Alinity ci-series

Global Customer Training

Alinity ci -series Global Customer Training | ADD-00066223 Intro-I

• the copyright notice appears on all copies;

• the Information is not modiﬁed in any way; and

• no graphics are used separate from accompanying text.

Intro-II Alinity ci -series Global Customer Training | ADD-00066223

Alinity ci -series Global Customer Training | ADD-00066223 Intro-III

· In a classroom environment with a lab instrument and other learners

Intro-IV Alinity ci -series Global Customer Training | ADD-00066223

· Handling samples, reagents, calibrators, and controls.

Alinity ci -series Global Customer Training | ADD-00066223 Intro-V

o Describe the major external and internal system components.

o Use the system software.

o Order and run specimens.

o Order and run assay calibrations and quality control samples.

o Complete maintenance activities.

o Troubleshoot common errors and issues.

o Remove and replace common components due to normal wear

Intro-VI Alinity ci -series Global Customer Training | ADD-00066223

Alinity ci -series Global Customer Training | ADD-00066223 Intro-VII

Intro-VIII Alinity ci -series Global Customer Training | ADD-00066223

Alinity ci -series Global Customer Training | ADD-00066223 Intro-IX

Intro-X Alinity ci -series Global Customer Training | ADD-00066223

In this module, you will explore:

Alinity ci -series Global Customer Training | ADD-00066223 1-1

o Identify the primary components of the system to support

o Identify the primary components of the system

o Describe the features of the system control module (SCM)

o Identify major external and internal system hardware components

o Identify the main elements of the User Interface screen, Home

o Log on to the System

o Lock the User Interface

o Access and navigate the online Operations Manual and Procedure

¥ Refer to the Alinity ci-series Operations Manual for more information.

Section 1 Use or Function subsections; Alinity ci-series hardware

Section 5 Operating Instructions subsections; Log On screen and Home

1-2 Alinity ci -series Global Customer Training | ADD-00066223

· An Alinity ci-series can be conﬁgured as:

¥ Note: A multimodule system includes multiple processing modules

Alinity ci -series Global Customer Training | ADD-00066223 1-3

A multimodule system includes multiple processing modules in different combinations of chemistry

· System Control Module (SCM)

1-4 Alinity ci -series Global Customer Training | ADD-00066223

· Processing Module: Performs all sample-processing activities from sample aspiration

¥ Refer to Alinity ci-series Operations Manual for more information

Section 1: Use or function > Alinity ci-series hardware overview >

System Control Module (SCM)

The System Control Module (SCM) contains the following items:

¥ Refer to Alinity ci-series Operations Manual for more information

Use or function > Alinity ci-series hardware overview > Primary

Alinity ci -series Global Customer Training | ADD-00066223 1-5

System Control Module (SCM)

¥ Refer to the Alinity ci-series Operations Manual for more information.

Section 1 Use or function>Alinity ci-series hardware overview>Primary

1-6 Alinity ci -series Global Customer Training | ADD-00066223

SCM Hardware Components

Identiﬁer Component Description