Abbott Afinion 2 User Manual

US User Manual

1116 554 , 1116 66 3

1116752 Rev. A 2018/09

Dear Customer,

Congratulations on the purchase of your Anion™ 2 Analyzer.

Upon arrival of your Anion 2 Analyzer we recommend that the serial number along with the software version be recorded in the table provided below. The
additional rows in the table are to be utilized if a software upgrade is performed on your Anion 2 Analyzer. The recorded information will be of great value if and
when a question is reported, or the desire to add a new Anion Test to your analyzer arises.

Serial number

(for serial number (SN), see label on the rear side of the analyzer or on the transport container)

Software records

Date

Upon receipt

1. SW upgrade

2. SW upgrade

3. SW upgrade

4. SW upgrade

5. SW upgrade

* See start-up menu when you power on the analyzer (see “How to power on the analyzer”, page 11).

Software version* Anion™ Tests available

Notes

_________________________________________________________________________________________________________________________________________________

_________________________________________________________________________________________________________________________________________________

Technical Support

Call 1.866.216.9505

2 | US

AFINION™ 2 User Manual

Intended use of the AFINION™ 2 System

Anion 2 System, consisting of the Anion 2 Analyzer and the Anion Test Cartridges, is for in vitro diagnostic use only. Anion 2 Analyzer is a compact multi-assay
analyzer for point-of-care testing and is designed to analyze the Anion Test Cartridges.

CLIA Statements - Waived Anion™ Tests

Anion HbA1c is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA`88). A CLIA Certicate of Waiver is needed to perform testing in a
waived setting.

If the laboratory does not have a Certicate of Waiver, the Application for Certication (Form CMS-116), can be obtained at
https://www.cms.gov/cmsforms/downloads/cms116.pdf.

The form should be mailed to the address of the local State Agency of the State in which the laboratory resides
(https://www.cms.gov/CLIA/12_State_Agency_&_Regional_Ofce_CLIA_Contacts.asp).

If the laboratory modies the Anion Test or Anion 2 Analyzer system instructions, the test no longer meets the requirements for waived categorization. A modied
test is considered to be highly complex and is subject to all applicable CLIA requirements.

Conformity to directives and standards

European IVD directive and RoHS 2 directive (CE marking)

The Anion 2 Analyzer meets all provisions in the Directive 98/79/EC on in vitro diagnostic (IVD) medical devices and in the Directive 2011/65/EU on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2).

North American product safety standards (CNUS mark)

The Anion 2 Analyzer has been tested and found to be in conformity with North American safety standards. See list of safety standards below.

Safety standards

The Anion 2 Analyzer has been tested and found to be in conformity with standards for Safety requirements for electrical equipment for measurement, control, and
laboratory use (IEC 61010-1:2010 , UL 61010-1:2012, CAN/CSA-C22.2: 61010-1 -12) and standard for Particular requirements for in vitro diagnostic (IVD) medical
equipment (IEC 61010-2-101:2015).

EMC standards

The Anion 2 Analyzer has been tested and found to be in conformity with standards for Electrical equipment for measurement, control, and laboratory use
– EMC requirements (EN 61326-1:2013, EN 61326-2-6:2006, EN 61326-2-6:2013 and CFR 47 Telecommunications, Chapter I- FCC Part 15 – Radio Frequency
Devices – Subpart B: unintentional radiators).

AFINION™ 2 User Manual

US | 3

4 | US

AFINION™ 2 User Manual

Table of Contents

Table of contents

Introduction About this user manual 7

Examining the package contents 7

Analyzer System Description Description of the AFINION™ 2 Analyzer 8

Description of the Anion™ Test Cartridge 8

How the AFINION™ 2 System works 9

Internal process control 9

The analyzer self-test 9

The fail-safe mechanisms 9

External process control 9

Patients ID 9

Operator ID 9

Quality Control lockout 9

Calibration 9

Getting Started Installing your analyzer 10

Connecting power supply 10

Connecting additional equipment 10

Connectivity 10

How to power ON the analyzer 11

How to power OFF the analyzer 11

How to operate the analyzer 11

Conguration The AFINION™ 2 menus 12

Setting the conguration 13

Patient ID conguration 13

Patient ID enable/disable 13

Operator conguration 14

Operator ID enable/disable 14

Operator login expiration 14

Operator list management 14

Choosing language 15

Adjusting screen/beeper settings 15

Setting date and time 15

QC lockout conguration 16

General settings 17

Erase all contents and conguration 17

Analyzer network settings 17

Connectivity settings 18

Quality Control Why quality control testing? 19

Choosing control material 19

Handling and testing controls 19

Frequency of control testing 19

Table of contents continues on next page

AFINION™ 2 User Manual

US | 5

Table of Contents

Testing Procedures Operating precautions 20

When operating the analyzer 20

When handling the test cartridge 20

Preparing for an AFINION™ 2 Analysis 20

Collecting a sample 21

Analysing a patient/control sample 21

Using the operator ID function 22

Entering operator ID 22

Using the patient ID function 22

Entering patient ID 22

Using the control ID function 23

Entering control ID 23

Using the QC lockout function 23

QC lockout status 23

Running controls with enabled QC lockout function 24

Patient and control results records 25

View, print and export patient and control results 25

Information Codes and
Troubleshooting

Maintenance Cleaning and maintenance 29

Warranty 30

Technical Specications AFINION™ 2 Analyzer 31

Gallery of Icons The touch buttons and their function 32

Symbols and Abbrevations 35

When an information code appears 26

Information codes caused by test-specic limitations 26

Information codes caused by sample or test cartridge 27

Information codes and messages caused by analyzer failure 27

Other information codes 28

Service information 28

Cleaning the exterior 29

Cleaning the cartridge chamber 29

Disposal of the analyzer 29

Software upgrade 29

Additional equipment 31

Other symbols and signs 34

6 | US

AFINION™ 2 User Manual

Introduction

About this user manual

This user manual will guide you through installation, operation and maintenance of your Anion 2 Analyzer. The user manual also explains how the analyzer works,
describes the quality assurance system and assists you in troubleshooting.

For analysing patient samples or controls, please also read the test specic information given in the package inserts following the Anion Test Kits. The quick
reference guides, available from your local Anion supplier, highlight the main steps of the test procedures.

It is recommended that you become familiar with these user instructions before you start operating the Anion 2 Analyzer.

Some of the information in this user manual is accompanied with a symbol that points you to the following particulars:

Warnings and precautions

References to the package inserts for the specic Anion Tests and control kits

Examining the package contents

When unpacking, check the contents against the list below and examine the components for signs of shipping damage.

The Anion 2 package unit includes:

• Anion 2 Analyzer

• Power cable

• Power supply, 24 VDC

• User manual

• Quick guides for the available Anion Tests

If the package unit is found incomplete, please report missing items or shipping damage to your supplier. It is recommended to keep the shipping box in case of
later transportation of the analyzer.

AFINION™ 2 User Manual

US | 7

Analyzer System Description

Description of the AFINION™ 2 Analyzer

Figure 1 shows the main exterior parts of the Anion 2 Analyzer.

1

2

3

4

5

Figure 1

1 ON/OFF button: Turns the power to the analyzer on and off.
2 Red and green LEDs: Light emitting diodes (LEDs) that indicates whether the analyzer is busy or not.
3 Touch screen: Allows you to communicate with the analyzer through touch buttons and messages.
4 The lid: Covers and protects the cartridge chamber.
5 Connectors: For connecting to mains power supply. Options for printer, barcode reader and/or LIS/HIS/EMR.

Do not open the lid manually.

Description of the Anion™ Test Cartridge

The Anion Test Cartridge is unique for each analyte to be measured, as the reagent composition, reagent volumes and the integrated devices are test specic.
The test cartridge label has a colour unique for the test. The test cartridges are separately packed in foil pouches to protect the reagents and plastic devices from
light, dirt and humidity. A single test cartridge contains all necessary reagents for one test and is ready to use. An integrated sampling device is used for collection
of the patient sample or control. The test cartridge cannot be reused. Figure 2 illustrates an Anion Test Cartridge with its functional parts:

Left side Right side

Figure 2

1 Sampling device: For collection of patient sample or control (1a - closed position, 1b - lifted position).
2 Capillary: Capillary to be lled with sample material.
3 Reaction wells: Contain all necessary reagents for one test.
4 Handle: For correct nger grip.
5 Barcode label: Contains assay and lot-specic information for the analyzer.
6 Optical reading area: Area for transmission measurement.
7 ID area: Space for written or labelled sample identication.

8 | US

AFINION™ 2 User Manual

Analyzer System Description

How the AFINION™ 2 System works

The Anion 2 System uses different chemical and mechanical assay methods combined with advanced, computerized processing and measuring technology.

A test cartridge with patient sample or control is placed in the cartridge chamber of the analyzer. By manually closing the lid, the test cartridge is transported
into the analysis compartment of the analyzer. Test and lot-specic information is obtained from the barcode label (Figure 2). When the test cartridge enters the
analyzer, the integrated camera reads the barcode which then initiates the processing of the test cartridge. The sample and reagents are automatically transferred
between the wells. An internal camera monitors the entire process. Light-emitting diodes (LEDs) illuminate the reaction area, which can be either a coloured
membrane or a reaction well. The camera detects the reected or transmitted light, which is converted to a test result and displayed on the touch screen. When the
user accepts the result, the lid covering the cartridge chamber opens automatically and the used test cartridge can be removed and discarded. The analyzer is then
ready for the next run.

Internal process control

The analyzer self-test

A self-test is performed during start-up of the analyzer to ensure that the instrument is operating according to established specications. The self-test validates:

• Hardware and software integrity

• Test cartridge transport system

• Liquid transport system

• Camera vision system

If the self-test fails at any point, the red LED will start ashing and an information code will be displayed on the touch screen
(see “Information codes and troubleshooting”, page 26-28).

When the analyzer is powered on for a longer period, it will automatically restart once a day to ensure that a self-test is done regularly. This procedure does not
interrupt any analysis of the test cartridge.

The fail-safe mechanisms

Fail-safe mechanisms are included to secure safe processing. The integrated camera inspects the test cartridges initially before the process starts and during the
assay. If defects are detected (e.g. broken capillary, the cartridge is used past its expiry date), the test cartridge is rejected and an information code is displayed.
During processing vital functions and components (e.g. pumps, heater) are supervised. When problems are detected by the built-in safety mechanism, the process
will be aborted and an information code will be displayed.

External process control

Patient ID

The Anion 2 patient ID functionality will, if congured, allow up to four patient ID elds to be entered. The patient ID will be stored with each patient test result in
the result records.

Operator ID

The Anion 2 operator functionality will, if congured, require the operators to login before testing. The functionality may also prevent unauthorized operators to
login, perform tests and conguration. The operator ID will be stored with each test result in the result records.

Quality Control lockout

The Anion 2 QC lockout function allows you to congure the instrument to automatically enforce your local required frequency of control testing. If the required control
test has not been performed or the control result is outside the acceptable range, the instrument will disable patient testing for this assay. For manufacturer recommen­dations (see “Frequency of control testing” page 19).

For more information regarding these functionalities, see “Conguration” page 12–18.

Calibration

The Anion 2 Analyzer has been manufactured to deliver reliable and accurate results. During manufacturing, the analyzers are calibrated against a reference sys­tem. This procedure has been established to ensure that all analyzers operate within identical tolerance limits.

Test specic calibration data are established for each lot of test cartridges and then stored in the barcode label (Figure 2). When the test cartridge enters the
analyzer, the integrated camera reads the barcode. The calibration data for the actual lot are transferred to the instrument and used for calculating the results.
Calibration by the operator is thus not required.

AFINION™ 2 User Manual

US | 9

Getting Started

Installing your analyzer

Place your Anion 2 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the analyzer is located with sufcient surrounding airspace, at least 5
inches on each side. Placement of Anion 2 Analyzer should allow easy disconnection from the wall outlet at any time. Acclimate the analyzer to ambient operating
temperature (15-32°C, 59-89°F) before use.

The analyzer might be impaired by:

• Condensing humidity and water

• Heat and large temperature variations

• Direct sunlight

Connecting power supply

- Connect the power cable to the power supply.

- Insert the plug from the power supply into the power socket (Figure 3) in the back of the analyzer.

- Plug in the power supply to a wall outlet.

Only use the power supply and cable supplied with Anion 2 Analyzer. Any other power supplies or cables can damage the analyzer and may cause possi­ble hazards.

Figure 3

1

1 Ethernet port for connection to LIS/HIS/EMR systems. Use shielded cable.

2

2 USB-A connectors for printer, USB ash and barcode reader.

3

3 Power input for power supply connection

• Vibrations (e.g. from centrifuges and dishwashers)

• Electromagnetic radiation

• Movement of the analyzer during processing of a test cartridge

Connecting additional equipment

Optional equipment, not provided with your Anion 2 Analyzer are:

• External barcode reader – for reading barcoded sample or operator identication.

• Printer – for optional print out of test results.

For additional information regarding barcode reader and printer specications, please contact your local Anion 2 supplier.

Connecting the equipment should be done while the analyzer is powered off.

All equipment connected to the USB and/or Ethernet ports must have double or reinforced insulation from mains to prevent the risk of electric shock.

Connectivity

Anion 2 Analyzer can reliably transfer test information to an information system. Use the Ethernet cable to interface the Anion 2 Analyzer to an information system.
Anion 2 Analyzer automatically transfers patient and control results to a connected LIS/HIS/EMR system via TCP/IP networking using the protocols POCT1-A,
HL7, ASTM 1381-85 (low level) or ASTM 1394-97 (high level), selectable by conguration. ASTM and HL7 protocols support the transfer of patient and QC
results. POCT1-A protocol supports in addition functions such as device lockout and operator list management. Operator conguration allows for protection of
connectivity settings. When operator conguration is set to operator ID with verication, the conguration of connectivity will only be available for operators at
supervisor level. For relevant information, see chapter “Operator conguration”, page 14.

When you export data that contains patient information, it is your responsibility to comply with your local regulations on protection of personal health information.

Anion 2 Analyzer POCT1-A, ASTM and HL7 communication protocols are available at www.alere.com or by contacting your local Anion 2 supplier.

10 | US

AFINION™ 2 User Manual

GETTING STARTED

How to power ON the analyzer

1

Power on the analyzer by pressing the ON/OFF button (Figure1). An automatic start-up procedure will be initiated. Please wait.
Do not open the lid manually.

Getting Started

2

3

The automatic start-up procedure will be initiated shortly after the analyzer has been powered on. The red light on the top of the analyzer will
turn on, indicating that the analyzer is busy. The analyzer is ready for use when the start-up menu is displayed and the green indicator light
turns on.

Start-up menu

The analyzer’s software version (SW X.XX) will appear in the upper left corner of the Start-up menu screen. The temperature displayed in the
Start-up menu is the operating analyzer temperature. Make sure that the operating temperature is within the recommended range for your
Anion Test (see the package insert for the Anion Test).
If the analyzer fails during the start-up procedure, an information code will appear referring to a message given in the section “Information
codes and troubleshooting”, page 26-28.

How to power OFF the analyzer

Switch off the analyzer by pressing the ON/OFF button (Figure 1). The analyzer should be powered off after the end of a working day.

The analyzer can only be powered off when the cartridge chamber is empty and the lid is closed. If the ON/OFF button is pressed and the lid is open, the
message ”Close lid” will appear on the screen.

How to operate the analyzer

The Anion 2 Analyzer has two main user interfaces, the touch screen and the cartridge chamber. The analyzer is easily operated using the touch buttons that appear
on the screen. When a button is touched, its function will be activated. Text messages that appear on the screen will help guide you through the testing procedure.
The functions of the touch buttons are explained in the section “Gallery of icons”, page 32–34.

The other main operative part of the Anion 2 Analyzer is the cartridge chamber. The cartridge chamber is designed to receive the test cartridge in one orientation
only. The lid must be manually closed, but opens automatically. When a new test cartridge is placed in the chamber, manually closing the lid will initiate the analysis.
When the analysis is complete the lid will open automatically. The lid protects the cartridge chamber from dust, dirt, light and humidity during processing and when
the analyzer is not in use.

• The lid must be manually closed, but opens automatically. Do not open the lid manually.

• Use the ngertips only on the touch screen. Do not use pens or other sharp instruments.

Figure 4

1

2

Screen saver

The screen saver will turn on after 3 minutes, if the touch screen is not in use. To reactivate, touch the screen.

Light signals (the red and green LEDs)

The red diode is illuminated when the analyzer is busy. A ashing red light is seen when an information code is displayed. The green diode is illuminated when the
analyzer is ready for use. A ashing green light indicates completion of an analysis.

Sound signals

A short beep indicates completion of an analysis. Two beeps mean that an information code or message is displayed.

1 Text message
2 Touch buttons

3

3 The cartridge chamber
with a test cartridge

4

4 The lid in open position

AFINION™ 2 User Manual

US | 11

Conguration

The AFINION™ 2 menus

Main menuStart-up menu

Patient ID conguration
menu

Language setting

Date/Time
menu

Conguration menu

Operator conguration
menu

Screen/beeper
menu

QC lockout conguration
menu

12 | US

General settings
menu

AFINION™ 2 User Manual

Conguration

Setting the conguration

Before using your Anion 2 Analyzer you should set the conguration according to your needs. To enter the Conguration menu, do the following:

1

Start-up menu

Touch to enter Main menu.

2

3

Main menu

Touch to enter Conguration menu.

Conguration menu

Select an item for conguration (see following pages).

Patient ID conguration

Patient ID enable/disable

The patient identication (ID) function can be enabled or disabled. The patient ID function is enabled as a default setting by the manufacturer. When the patient
ID function is enabled, the patient ID must be entered for each test cartridge to be analyzed. If the patient ID function is disabled, a run number will automatically
replace the patient ID and be displayed in the upper left corner of the screen. This numbering is reset each day at midnight.

Touch

in the conguration menu to enter the patient ID on/off option.

Select to disable the patient ID function.

Select to enable the patient ID function.

Touch to accept and return to the Conguration menu.

AFINION™ 2 User Manual

US | 13

Conguration

Operator conguration

The operator ID function is disabled as a default setting by the manufacturer.
Touch

Operator ID enable/disable

Touch

Operator login expiration

Touch

in the Conguration menu to enter the Operator conguration menu.

in Operator conguration menu to enable/disable operator ID.

Select to disable the operator ID function.

Select to enable operator ID. Any operator ID is accepted.

Select to enable operator ID with verication.

· To enable this function at least one supervisor is required to be present in the operator list.

· When operator ID with verication is enabled, analyzer conguration will only be available to the supervisors.

· To log in, the operator ID entered is required to be present in the operator list. See “Operator list management”, page 14.

Touch to accept and return to the Conguration menu.

in the Operator conguration menu to set automatic logout of the operator.

Enter the number of minutes before automatic logout of operator.

The operator will automatically be logged out after the congured number of minutes after ended test.

Touch to conrm and return to previous view.

Operator list management

Touch

1

2

3

in Operator conguration menu to enter operator list.

Touch to add new operator.
Touch desired operator ID and touch to delete or to edit the highlighted operator.

Copy operator list

It is possible to copy an existing operator lists between analyzers using a USB ash drive. Insert USB ash in the analyzer USB port.
Touch to export operator list from instrument to USB ash. Move USB to the new analyzer and touch
existing operator list on the analyzer will be deleted.

Enter new/edit operator ID

Enter new/edit operator ID and touch to enter. Both letters and numbers can be entered (maximum 16 characters).
If a barcode reader is connected to the analyzer, a barcoded operator ID can be entered.

Congure the operator level

Select USER to congure user access.

Select SUPERVISOR to congure supervisor access.

Congure tests accessible:

Select the test accessible for this operator.

Touch to return and edit the operator ID.

Touch to accept and store new operator in the operator list. The operator list can store 1000 operator IDs.

Supervisors will be marked with * in the operator list. When analyzer is congured to Operator ID with verication, conguration of the
analyzer will only be available to the supervisors.

to import operator list. Any

14 | US

AFINION™ 2 User Manual

Conguration

Choosing language

Touch in the Conguration menu to enter the language setting. The default setting by manufacturer is English. Other languages are available.

1

Touch the arrow in the window to view other options. Scroll down until you nd the preferred language.

Touch to accept and return to the Conguration menu.

Adjusting screen/beeper settings

Touch in the Conguration menu to enter the Screen/beeper menu.

Touch to enter the Screen alignment setting.

Touch to enter the Beeper volume setting.

A + sign is shown. Use a blunt pencil and tap the center of the +. Repeat tapping the center of the + each time it is shown. When the
process is nished, the previous screen will return.

Adjust the beeper volume by touching or

Touch to conrm and return to the previous view.

Setting date and time

The correct date and time should always be set because the date and time for the analyses are stored and displayed in the patient and control records. The
date format is YYYY:MM:DD, where YYYY is the year, MM is the month (01 to 12), and DD is the day (01 to 31). The time format is hh:mm, where hh is the hour
from 00 to 23 and mm is minutes from 00 to 59.

Touch in the Conguration menu to enter Date/time menu.

1

2

Touch to enter Date setting.

Touch to enter Time setting.

Enter today’s date or time.

Touch to conrm and return to the previous view.

AFINION™ 2 User Manual

US | 15

Conguration

QC lockout conguration

Touch in the Conguration menu to enter the QC lockout conguration menu.

Touch to congure QC lockout for the assay selected.

Touch to congure QC lockout interval.
Touch to view/add/delete stored control lots in the control lot database.

1

HbA1c

ACR

2

3

4

Select assay for QC lockout conguration

Touch the arrow in the window to open the drop down menu.

Touch the assay to select.

QC lockout

Select to disable the QC lockout function. No QC runs will be required for this assay.
Select to enable the QC lockout function. It is required to run ONE passed control,

control level C I OR C II, to reset the QC lockout interval.
Select to enable the QC lockout function. It is required to run TWO passed controls,

both control level C I AND C II, to reset the QC lockout interval.
Touch

QC lockout interval

Select
Select to congure QC lockout interval by hours.

Touch

Touch

Control lot database

To add a control to the control lot database the Anion Control Data is required.
The Anion Control Data is a numeric data string which contains all lot specic data:

• Anion Control lot number

• Control type (assay)

• Control level (C I or C II)

to conrm and return to the previous view.

to congure QC lockout interval by number of runs.

to enter/edit number of runs/hours to QC lockout.

displays the number of runs/hours congured in the QC lockout interval.

to conrm and return to the previous view.

• Control expiry date

• Acceptable control range

• CRC (check sum to validate the previous data)

16 | US

The Anion Control Data and its accompanying barcode is found in the Anion Control Package Insert. If the Anion Control Data is not
available, contact your local supplier.

Touch and either manually enter the Control Data or if a barcode reader is connected to the analyzer (recommended), scan the
barcode.
The Anion Control Data may also be entered before, during or after a control run. The control lot will automatically be stored in the
database. See page 25.

Select lot number and touch to delete a control from the list.
When a control lot has reached its expiry date, the control will automatically be deleted from the instrument control database. The control
lot database can store 100 control lots.

AFINION™ 2 User Manual

General settings

Touch

in the Conguration menu to enter the General settings menu.

Conguration

Touch

Touch

Touch

to erase all content and congurations.

to enter Instrument network settings.

to enter Connectivity settings.

Erase all contents and congurations

Touch

in General settings menu to erase all contents and congurations.

Touch

Touch

to erase all content and congurations.

to cancel and return to General settings menu.

Analyzer network settings

See Table 1 for description of the available analyzer network settings.

Touch

to enter Instrument network settings view.

Touch

to congure the network.

Enter the IP Address. Touch

Enter the Gateway. Touch

Enter the Network mask. Touch

Enter the Hostname. Touch to conrm and return to Instrument network settings view.

Touch

Table 1 Description of the available analyzer network settings

Consult your network administrator and LIS/HIS/EMR administrator for required network settings.

DHCP DHCP is turned on/off by selecting “DHCP”.

IP address Insert xed IP address [0-255/0-255/0-255/1-254]

Gateway Insert Gateway [0-255/0-255/0-255/1-254]

Network Mask Insert Network mask [0-255/0-255/0-255/0-255]

Host name Insert Host name. Valid characters are [A-Z], [0-9], [-]. The length can be from 1-16 characters

to accept and return to the General settings menu.

When using DHCP the instrument’s IP address will be assigned by the DHCP Server.
No other network settings are necessary.
NB! If DHCP is activated, only the hostname setting can be edited.

to conrm and continue to Gateway.

to conrm and continue to Network mask.

to conrm and return to Hostname.

AFINION™ 2 User Manual

US | 17

Conguration

Connectivity settings

See Table 2 for description of the available Connectivity settings.

Touch

Touch to enter page 2 of the conguration or to return to the General settings menu

Touch to enter Server IP and Port number, Receiving application (available for ASTM HL, ASTM LL and HL7 only) and Receiving facility (available
for HL7 only).

Enter the server IP address: Press

Enter the server port number setting: Touch

Enter the Receiving application setting: Press

Use the button to select Patient ID as (available for HL7 only):

HIS Patient ID

Visit Number

in General settings to enter Connectivity settings

Select appropriate communication protocol

ASTM HL

ASTM LL

HL7

POCT1-A

Communication protocol is disabled as default.
Select which results to be transferred to LIS/HIS/EMR by selecting the appropriate button

Patient results only

Patient and control results

Select “New results only” and previous obtained results will not be transferred to the LIS/HIS/EMR

to continue to the Port number setting.

to continue to the Receiving application setting or to close the text input.

to continue to the Receiving facility setting or to close the text input.

Touch

Table 2 Connectivity settings

Consult your network administrator and LIS/HIS/EMR administrator for required connectivity settings.

Protocol ASTM HL ASTM High Level: The communication protocol is based on ASTM E 1394 - 97

Results Patient results only Only patient results will be transferred to the LIS/HIS/EMR

Server IP Insert the IP address of the receiving system [0-255.0-255.0-255.1-254]

Port [0-65535] (0 = not set)

Receiving
Application

Receiving Facility (HL7 only)

Patient ID As HIS Patient ID (HL7 only)

For further information about the connectivity settings, see the Anion 2 data sheets for POCT1-A, ASTM and HL7 which can be obtained at www.Alere.com or
through your local Anion supplier.

to return to the General Settings menu

ASTM LL ASTM Low Level: The communication protocol is based on ASTM E 1381 - 95

HL7 HL7: The communication protocol is based on HL7 version 2.4

POCT1-A POCT1-A: The communication protocol is based on CLSI: POCT01-A2 Point-of-Care Connectivity; Approved

Disabled Data connectivity is disabled

Patient and quality
control

Visit Number (HL7 only)

Standard – Second Edition

Both patient and QC results will be transferred to the LIS/HIS/EMR

(ASTM HL, ASTM LL and HL7 only)
Receiving application name (0 – 30 characters)

Receiving facility name (0-30 characters)

18 | US

AFINION™ 2 User Manual

Quality Control

Why quality control testing?

Quality control testing should be done to conrm that your Anion 2 System is working properly and provides reliable results. Accurate results for patient samples
can only be assured when controls are used routinely and the values are within the acceptable ranges.

Choosing control material

Controls supplied by Alere Technologies AS are recommended for use with the Anion 2 System. These control kits contain control materials with established
acceptable ranges for the Anion 2 System.

If you decide to use controls from another supplier, you will need to determine their precision and to establish acceptable control ranges for the Anion 2 System.

Handling and testing controls

Consult the package insert that comes with each control kit for detailed instructions on handling and storage of the control material.

To run a control, follow the procedure in the section “Testing procedures”, page 20-25.

The measured value should be within the acceptable range stated on the control vial label or in the control package insert. If the control results are within the
acceptable ranges, patient samples may be tested and results reported.

If the result obtained for a control is out of range, make sure that:

- The control vial has not passed its expiration date.

- The control vial has not passed the declared stability for opened vials.

- The control vial and Anion Test Cartridges have been stored according to recommendations.

- There is no evidence of bacterial or fungal contamination of the control vial.

Correct any procedural error and retest the control material. If no procedural errors are detected, it is recommended to examine the laboratory’s quality control
record to investigate the frequency of control failures. Ensure that there is no trend in out-of-range quality control results. Retest the control material using a new
control vial.

Patient results must be declared invalid when controls do not perform as expected. Contact your Technical service representative (1.866.216.9505) for
advice before analyzing patient samples.

Frequency of control testing

It is recommended that controls are analyzed:

• When starting up an Anion 2 Analyzer for the rst time.

• With each new shipment of Anion Test Kits.

• With each new lot of Anion Test Kits.

• Anytime an unexpected patient test result is obtained.

• When training new personnel in the correct use of the Anion 2 System.

• If national or local regulations require more frequent testing of control materials, perform quality control in compliance with the regulations for your facility.

• Users with a low frequency of testing should analyze controls at least every 30 days.

The controls should always be analyzed if an unexpected test result is obtained (see the Anion Test Package Insert, section Test result reporting). If
local, state and/or federal regulations require more frequent testing of control materials, then quality control should be performed in compliance with these
regulations. Each laboratory site can benet from establishing a quality control plan. The laboratory director should determine whether additional testing is
appropriate for their laboratory.

AFINION™ 2 User Manual

US | 19

Testing Procedures

Operating precautions

When operating the analyzer:

• Use your ngertip to operate the touch screen. Do not use pens or other objects that may scratch or damage the screen. Exception: If the screen
alignment function is required, you will need to use a blunt pencil.

• The lid opens automatically, but must be closed manually. Do not try to open the lid manually.

• The lid protects the cartridge chamber from dust, dirt, light and humidity. Empty the cartridge chamber and keep the lid closed when the analyzer
is not in use.

• If an information code appears on the screen during the analysis, please consult the “Information codes and troubleshooting” section, page 26-28.

• Do not move the analyzer when a test cartridge is being processed.

When handling the test cartridge:

• Do not use test cartridges after the expiration date, or if the test cartridges are not stored in accordance with the recommendations.

• Do not touch the test cartridge optical reading area. Hold the test cartridge by the handle. (Figure 2).

• Do not use the test cartridge if the foil pouch, the desiccant bag or the test cartridge itself is damaged.

• The test cartridges must reach recommended operating temperature before use.

• Do not open the foil pouch until just before use. Once opened, the test cartridge has limited stability.

• Handle and dispose the test cartridges and sample collection equipment as potential biohazardous materials. Use gloves.

• Do not reuse any part of the test cartridge.

Consult the package insert that comes with each Anion Test Kit for assay specic information.

Preparing for an AFINION™ 2 analysis

- Allow the Anion Test Cartridges to reach the recommended operating temperature before use.

- Power on your Anion 2 Analyzer so it is ready for the day’s rst analysis.

- Enter the operator ID (optional). See procedure on page 22.

- The patient ID, control ID or Anion Control Data can be entered before or during processing of the test cartridge in the analyzer.
See procedures on page 22-25.

Consult the package insert that comes with each Anion Test Kit for assay specic information.

Tear strip

1

Open the foil pouch. Grip the handle and remove
the test cartridge from the pouch.
Discard the desiccant bag and foil pouch in
suitable waste containers.

When rst opened, the test cartridge has limited
stability.

If a barcode reader is connected to the analyzer, a barcoded patient ID, control ID or Anion Control Data can be entered.

2 3

Inspect the cartridge. Do not use the test
cartridgeif it is damaged or if loose desiccant
particles are found on the test cartridge.

Use the handle to avoid
touching the optical reading area.

Mark the test cartridge with the patient
or control ID. Use the ID area on the test
cartridge. An ID label can also be used.

Do not write on the barcode label or allow
it to become wet, dirty or scratched.
If an ID label is used, this must t into the
ID area.

20 | US

AFINION™ 2 User Manual

Testing Procedures

Collecting a sample

• The patient sample material and control material to be used is specic for each Anion Test.

• The length of the capillary in the sampling device, and thereby the sample volume, might also vary for the different Anion Tests.

• The time from lling the capillary until analysing the test cartridge must be as short as possible.

• Do not use the test cartridge if dropped on the bench or oor after the sample has been collected.

Consult the package insert that comes with each Anion Test Kit for assay specic information.

Examples:

1 2 3

Remove the sampling device from the test
cartridge.

Use the handle to keep the test cartridge steady
against the table and pull the sampling device
straight up.

Fill the capillary; hold the sampling device almost
horizontally and bring the tip of the capillary in
surface contact with the sample. Make sure that
the capillary lls completely. It is not possible to
overll.
Do not wipe off the capillary.

Avoid air bubbles and excess sample on the
outside of the capillary.

Immediately and carefully replace the
sampling device into the test cartridge.

The time from lling the capillary until
analysing the test cartridge must be as
short as possible.

Analysing a patient/control sample

1 2 3

Touch to enter the patient sample mode.

Touch to enter the control mode.

The lid opens automatically.

Insert the test cartridge with the barcode label
facing left.

Be sure that the test cartridge is correctly placed in
the cartridge chamber.

A “C” in the upper left corner indicates that the
analyzer is in the control mode.

4 5 6

Touch and enter the patient ID.

Touch to conrm.

Touch and enter the control ID or Anion
Control Data.

Touch to conrm.

Entering the patient ID, control ID or Anion Control
Data will not interrupt the processing.

Record the result, then touch to accept.

If a printer is connected, touch to print
the result.

The lid opens automatically.

The result will be saved in the result records.

Close the lid manually.The analyzer will start
processing the test cartridge.

The processing time depends on the test
in use.

Remove the used test cartridge from the
cartridge chamber and discard it in a
suitable waste container.

Insert a new test cartridge or close the lid
manually.

Keep the lid closed to protect the cartridge
chamber when the analyzer is not in use.

Consult the package insert that comes with each Anion Test Kit for assay specic information.

AFINION™ 2 User Manual

US | 21

Testing Procedures

Using the operator ID function

Entering operator ID

If enabled, the operator’s identication (ID) is required before processing an Anion Test Cartridge (see “Operator conguration”, page 14).
Both letters and numbers can be entered (maximum 16 characters). The operator ID will be displayed with the result and stored along with the other specic data
for this run (see “Patient and control results records”, page 25).
If congured to “enabled with verication” the operator ID entered is required to be present in the operator ID list (see “Operator conguration”, page 14).

Enter the operator ID by numbers and/or touch to enter letters. If a barcode reader is connected to the analyzer, a bar coded
operator ID can be entered.

Touch to conrm and return to previous view.

The operator will be automatically logged out according to the conguration (see “Operator conguration” page 14).

The operator may also manually logout by using the operator logout button displayed in the Start-up menu.

Using the patient ID function

The patient ID function is enabled as a default setting. As long as this function is enabled, the patient ID must be entered for each patient sample to be analyzed. The
patient ID function can be disabled (see “Patient ID conguration”, page 13).

Entering patient ID

It is recommended to enter the patient ID during processing of the test cartridge in the analyzer. Entering the patient ID will not interrupt the processing. It is also
possible to enter the patient ID before the processing.

1

2

3

The P-ID 1 will be stored in the memory and displayed along with the other specic data for this run (see “Patient ID conguration” page 13). Patient ID 2-4 will not
be displayed in the result records but will be stored in the memory and appear on printouts and data transferred to data management systems.

Touch to enter the patient ID option.

It is possible to enter up to four patient ID entries for each patient, P-ID 1 to 4. When enabled, P-ID 1 is required to be entered. Scrolling
between the patient IDs is done with the and .

Enter patient ID by numbers and/or touch to enter letters (maximum 16 characters).
If a barcode reader is connected to the analyzer, a barcoded patient ID can be entered.

Touch to conrm and return to previous view.

The entered P-ID 1 will appear on the screen.

The patient ID touch button will remain in the view and it is possible to make corrections.

22 | US

AFINION™ 2 User Manual

Testing Procedures

Using the control ID function

In quality control testing, a suitable control ID must always be entered. The lot number of the control material is recommended as a suitable control ID. The control
ID function cannot be disabled.

Entering Control ID

It is recommended to enter the control ID during processing of the test cartridge in the analyzer. Entering the control ID will not interrupt the processing. It is also
possible to enter the control ID before processing. Both letters and numbers can be entered (maximum 16 characters). The control ID will be stored in the memory
and displayed along with the other specic data for this run.

To enter the control ID during processing, do the following:

1

2

3

Touch to enter the control ID option.

Enter control ID by numbers and/or touch to enter letters.
Touch to conrm and return to the previous view.

The entered control ID will appear on the screen.
The control ID touch button will remain in the view and make corrections possible.

Using the QC lockout function

When the QC lockout function is enabled for one or more assays, approved control testing is required within the congured interval. If the interval expires, patient
testing for the assay will be locked. A passed control run must be performed according to conguration to reset the interval or to unlock the assay for patient testing.
A failed control run will disable patient testing (see “QC lockout conguration”, page 16).

QC lockout status

The status of the active QC lockouts is presented with a QC lockout status button (padlock symbol) visible in the Start-up menu. This gives the operator the status
of QC lockout before he attempts to run any tests.
The padlock symbol will only be visible if QC lockout function is enabled for one or more assay types.

The padlock symbols used are:

Enabled-unlocked

All controls are within the congured interval. It is possible to run patient tests for all assays.

Warning-unlocked

All controls are within the congured interval. When one or more of the assays has 10 % or less of the congured interval remaining the

warning icon will be displayed. It is possible to run patient tests for all assays.

Expired-locked

One or more controls have expired according to the congured interval. Patient testing on the expired assay has been locked.

AFINION™ 2 User Manual

US | 23

Testing Procedures

Touch the QC lockout status button (padlock symbol) in the Start-up menu to enter the QC lockout status view.

Status

The information is displayed as a list.

Only the assays with QC lockout activated are displayed in this window.

Red text indicates expired assays and orange text indicates assays within warning period.

Control level

How to reset QC lockout interval and/or unlock expired assays.

If no control level is specied, it is required to run ONE passed control, control level C I OR C II, to reset the QC lockout interval and unlock
the assay for patient testing.

E.g.

HbA1c: #0

If the control level is specied it is required to run TWO passed controls, both control level C I AND C II, to reset the QC lockout interval
and unlock the assay for patient testing.

E.g.

ACR C I: 00.00.00

ACR C II: 00.00.00

Remaining time/runs

Remaining time (dd:hh:mm) or number of runs for each assay with active QC lockout is shown. dd is the number of days, hh is the number
of hours, and mm is the number of minutes until the assay will be locked. # is number of patient tests.

Running controls with enabled QC lockout function

When running controls with the QC lockout function enabled, the Anion Control Data is required to be entered or previously stored in the instrument control lot
database. See “QC lockout conguration”, page 16.

1) The Anion Control Data is entered before, during or after the control run. If a barcode scanner is connected (recommended) the control data barcode may be
scanned. The control lot will automatically be stored in the instrument control database.

2) If the Anion Control Data is previously stored in the instrument control database, the operator will simply need to enter the 8 digit control lot number before,
during or after the control run.

If the instrument is congured to QC lockout and the control lot number is not found in the Anion Control database or the Anion Control Data entered is not valid,
the instrument will present an option to retry the input or discard the control run result. If discarded, the result will not be stored in the instrument result records.

Passed (result within the acceptable control range)

The result of the control is checked against the acceptable ranges for the corresponding lot number.

If the result is within the limits, a pass symbol is displayed on the screen and the QC lockout interval is reset according to the QC lock­out conguration.

If QC lockout is congured to require two control levels (C I and C II), both levels must pass to reset the
lockout interval. Only the interval for the control level used in the test is reset.

Failed (result above or below the acceptable control range)

When a control result is not within the acceptable ranges specied for the control lot, a failed symbol is shown on the screen. The result
is stored in the instrument and is sent to the data management system if connected. The QC lockout interval will not be reset.

The arrow symbol will specify whether the result is above or below the acceptable ranges.
See “Handling and testing controls”, page 19.

24 | US

AFINION™ 2 User Manual

Testing Procedures

Patient and control results records

The patient and control results are stored in the memory of the Anion 2 Analyzer. The last 500 patient results and the last 500 control results are saved in separate
records. When exceeding the capacity of 500 results, the oldest result will be deleted. The following parameters are listed for each run: Date and time, run number,
patient ID/control ID, operator ID, lot number of test cartridge and the test result.

View, print and export patient and control results

1

Main menu

Touch to enter patient results.

Touch to enter control results.

2

Result records may be exported if an USB ash (FAT 32 formatted) is inserted to the Anion 2 USB port.

Touch to export the results. The results will be stored on the USB in a .txt le for each assay tested on the Anion 2 Analyzer. These
les may be opened in e.g. Microsoft Excel for further processing.

When you export data that contains patient information, it is your responsibility to comply with your local regulations on protection
of personal health information.

The last patient result or control is displayed

To view more results touch

If a printer is connected, touch

or

to print the result.

AFINION™ 2 User Manual

US | 25

Information Codes and Troubleshooting

When an information code appears

Information codes that might appear during use of the Anion 2 Analyzer refer to specic information or error messages. The code numbers, the possible causes and
actions to take are listed below.

If the analyzer detects a problem during processing of a test cartridge, the test will automatically be aborted and the test cartridge will be safely moved to the
cartridge chamber. Proceed as follows:

1

2

3

Do not reuse a test cartridge that has been rejected by the analyzer. Collect a new sample and repeat the test with a new test cartridge.

Record the code number (#) and touch to accept.

The lid opens automatically.

Remove the test cartridge.

If the test cartridge is not ejected, restart the analyzer.

Do not reuse the test cartridge.

Look up the possible cause from the table below, and take actions to solve the problem.

If the problem persists, contact your local Anion supplier (see “Service information” page 28).

Information codes caused by test-specic limitations

[#] Cause Action to take

103 Hemoglobin too low Consult the Anion HbA1c Package Insert.

104 Hemoglobin too high Consult the Anion HbA1c Package Insert.

105 HbA1c too low Consult the Anion HbA1c Package Insert.

106 HbA1c too high Consult the Anion HbA1c Package Insert.

107 Creatine too high Consult the Anion ACR Package Insert.

108 Blood in urine Consult the Anion ACR Package Insert.

26 | US

AFINION™ 2 User Manual

Information Codes and Troubleshooting

Information codes caused by sample or test cartridge

[#] Cause Action to take

201 Insufcient sample volume:

- Empty capillary

- Air bubble in capillary

- Capillary incompletely lled

202 Excess sample on the sampling

device exterior

203 Wrong sample material Repeat the test with a new sample and test cartridge. Ensure that proper sample material is used (see package insert

204 Coagulated sample Repeat the test with a new sample and test cartridge.

Hemolysed blood sample or
poor sample quality

Test cartridge or analyzer failure Repeat the test with a new sample and test cartridge.

205 Capillary cracked or damaged Repeat the test with a new sample and test cartridge.

206 Barcode label not readable

(dirty or damaged)

207 - No sampling device inserted Repeat the test with a new sample and test cartridge. Ensure that the correct sampling device is in place and that the

- Sampling device belongs to
another Anion Test

- Label on sampling device not
readable (dirty or damaged)

208 Test cartridge previously used Repeat the test with a new sample and test cartridge.

209 Test cartridge has passed

expiration date

The date in the analyzer is
incorrectly set

210 Test cartridge temperature

too low

211 Test cartridge temperature

too high

212 Software upgrade is required

to run this test.

213

Test cartridge or analyzer failure Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

214

215 Test cartridge or analyzer failure Repeat the test with a new sample and test cartridge. If the problem persists, restart the analyzer and run controls.

Hemolysed blood sample or
poor sample quality
(Anion HbA1c)

217 Hemolysed blood sample or

poor sample quality
(Anion HbA1c)

218 Condensation detected on

cartridge

Repeat the test with a new sample and test cartridge.
Ensure that the capillary is completely lled with no air bubbles (see package insert for the Anion Test in use).

Repeat the test with a new sample and test cartridge. Ensure that only the tip of the capillary is in contact with the
sample (see package insert for the Anion Test in use).

for the Anion Test in use, section “Specimen collection and storage”).

The time from lling the capillary until analyzing the test cartridge should be as short as possible.

Consult the Anion Package Insert.
Repeat the test with a new sample and test cartridge.

If the problem persists, restart the analyzer and run controls.

Inspect the sampling device before use and handle with care.

Repeat the test with a new sample and test cartridge.
If the problem persists, restart the analyzer and run controls.

sampling device label is clean.

Check expiry date on the foil pouch or kit container. Repeat the test using a new sample and a new test cartridge
fromanother lot.

Check the date in the analyzer to make sure it is set correctly. Repeat the test with a new sample and test cartridge.

Repeat the test with a new sample and a new test cartridge.
Ensure that the operating temperature is within acceptable range (see package insert for the Anion Test in use).

Repeat the test with a new sample and a new test cartridge.
Ensure that the operating temperature is within acceptable range (see package insert for the Anion Test in use).

Contact your local supplier for assistance.

Consult the Anion HbA1c Package Insert. Repeat the test with a new sample and test cartridge.

Consult the Anion HbA1c Package Insert. Repeat the test with a new sample and test cartridge.

Run a new test cartridge. Ensure that the cartridge is equilibrated to room temperature before the foil pouch is opened.

Information codes and messages caused by analyzer failure

[#] Cause Action to take

27
2829Start-up procedure failed Contact your local supplier for assistance.

Self-test

error.

Analyzer

in non-

operative

mode

Analyzer failure Restart analyzer. If the problem persists, contact your local Anion 2 supplier.

301 Self-test failed Restart the analyzer.

302 Analyzer failure Restart the analyzer and run controls. Repeat the test with a new sample and test cartridge.

303 Analyzer temperature is too

high

304 Analyzer temperature is

too low

Ensure that the operating temperature is within recommended range (15-32ºC, 59-89 °F).
Wait until the analyzer has cooled down. Repeat the test with a new sample and test cartridge.

Ensure that the operating temperature is within recommended range for the Anion Test in use (see package insert).
The analyzer temperature is displayed in the Start-Up menu (see page 11). Repeat the test with a new sample and test
cartridge.

AFINION™ 2 User Manual

US | 27

Information Codes and Troubleshooting

[#] Cause Action to take

305 Printer improperly connected

Malfunction of the printer

Touch

screen

error

Touch screen failure/ Touch
screen buttons do not
respond accurately

Other information codes

[#] Cause Action to take

401 No registered supervisors in

operator list

402 Cannot delete last

supervisor

403 This assay type is not

accessible to the operator

404 Operator ID is not found in

operator list

[#] Cause Action to take

501 The control lot has passed

expiration date

502 Anion Control Data is not

recognised and is not stored
in control lot database

503 Control verication aborted. The Anion Control Data entered was not recognised. The control test was aborted by the operator. Test result was

504 Required control test interval

has expired. Patient testing
is disabled for this assay.

Switch off the analyzer, reconnect the printer and restart the analyzer.
If the message persists, see the printer user manual.

Restart analyzer and realign screen.

At least one supervisor is required in the operator list when the analyzer is congured to operator ID veried,
(see page 14).

At least one supervisor is required in the operator list when the analyzer is congured to operator ID veried,
(see page 14).

The operator logged in does not have access to run this assay type. Please contact your supervisor.

When Operator ID with verication is enabled, operator ID entered is required to be present in the operator list,
(see page 14). Please contact your supervisor.

Check the expiration date on the control lot package insert or kit box.
Repeat the test using a sample from a new control lot.

Reenter the Anion Control Data, (see page 16).

not stored. Run new control test to reset QC lockout interval.

A passed control run must be performed according to conguration to unlock this assay for patient testing.

[#] Cause Action to take

601 Operator list or control lot

database is full

The operator list can store 1000 operators and the control lot database can store 100 control lots. Delete an operator
or control lot to enter a new item

Service information

The laboratory must notify the manufacturer of this test system of any performance, perceived or validated, that does not meet the performance
specications as outlined in the instructions.

The manufacturer provides a toll free line for technical support: 1.866.216.9505

The toll free number is available for use only in the United States of America.

Before asking for assistance, please record the following information:

• Anion 2 serial number (SN) – see label on the backside of the analyzer

• Software version number – see Start-up menu.

• Anion Test type

• Test cartridge or kit lot number – see foil pouch or kit container

• Control identication and lot number – see vial label

• Control results obtained

• Description of the problem with reference to information codes or messages

28 | US

AFINION™ 2 User Manual

Maintenance

Cleaning and maintenance

No maintenance of the Anion 2 Analyzer is required other than cleaning the exterior and cartridge chamber.

Cleaning the exterior

Cleaning the exterior of the Anion 2 Analyzer should be performed whenever necessary. Most spills and stains can be removed with water or a mild detergent.

- Power off the analyzer. Unplug the power supply when the shut down procedure is completed.

- Clean the outside of the analyzer and the touch display with a clean, lint-free and non-abrasive cloth dampened in water or a mild detergent.

- To disinfect the exterior of the analyzer use a 1:10 solution of household bleach (i.e., 0.5% sodium hypochlorite), 2% glutaraldehyde solution or 70% alcohol
solution. The surface of the analyzer should be exposed to the disinfectant for at least 10 minutes.

- Allow the analyzer to air dry.

- Plug in the power supply and power on the analyzer.

• The analyzer must be powered off and unplugged before cleaning.

• Do not use any cleaning liquid or equipment other than those recommended above.

• Do not immerse the analyzer in water or other liquids.

Cleaning the cartridge chamber

The Cleaning Kit (

The cartridge chamber should be cleaned immediately if materials or liquids are spilled in the cartridge chamber. For regular maintenance (removal of dust
particles etc.), the cartridge chamber should be cleaned every 30 days.

- Touch to open the lid.

- Unplug the power supply.

- Wet a Cleaning Swab with 3 drops of water and gently rinse the cartridge chamber. To disinfect the surface, use a 1:10 solution of household bleach (i.e., 0.5%
sodium hypochlorite), 2% glutaraldehyde solution or 70% alcohol solution). Do not soak.

- Carefully remove spills and particles from the cartridge chamber using the moistened swab.

- To disinfect the cartridge chamber, the surface of the chamber should be exposed to the disinfectant for at least 10 minutes1.

- Wipe off any residual liquid from the cartridge chamber using a new, dry Cleaning Swab.

- Plug in the power supply, and power on the analyzer by pressing the on/off button.

- The lid will close automatically during the self-test. If it doesn’t, then close it manually and restart the analyzer.

1116048) should always be used for cleaning the cartridge chamber.

• The analyzer must be unplugged before cleaning.

• Do not use any cleaning liquid or equipment other than those recommended above.

• Do not allow liquid to drip off the Cleaning Swab into the analyzer. If liquid drips into the analyzer, optics can be destroyed.

• Do not immerse the analyzer in water or other liquids.

• Do not move or tilt the analyzer when cleaning the cartridge chamber.

Disposal of the analyzer

For correct disposal according to the Directive 2012/19/EU (WEEE), contact your local Anion 2 supplier.

Software upgrade

Consult the Anion USB Flash Drive Package Insert for software upgrade.

1

Clinical and Laboratory Standards Institute (CLSI) Guideline M29-A3: ”Protection of Laboratory Workers From Occupationally

Acquired Infections; Approved Guideline - Third Edition”. ISBN 1-56-238-567-4

AFINION™ 2 User Manual

US | 29

Warranty

Alere Technologies AS warrants solely to the Buyer that the Anion 2 Analyzer will be free from defects in materials and workmanship, when given normal, proper
and intended usage, and will perform in accordance with Alere Technologies AS’s specications for a period of twelve months from the date of delivery.

At its expense, Alere Technologies AS agrees to repair, or at Alere Technologies AS’s option, replace with a new or reconditioned unit, any Anion 2 Analyzer which
is under warranty and not performing substantially in accordance with applicable product specications, provided that the Buyer has given Alere Technologies
AS notication of such warranty claim within the warranty period. If Alere Technologies AS is unable after reasonable efforts to repair or replace the Anion 2
Analyzer not performing substantially in accordance with applicable product specications, the Buyer’s sole remedy shall be the refund of an amount not to
exceed the actual purchase price paid by the Buyer for the Anion 2 Analyzer. All repairs will be done during normal working hours. All replaced parts shall become
Alere Technologies AS’s property. Alere Technologies AS may require the Buyer to ship the Anion 2 Analyzer to Alere Technologies AS or elsewhere at Alere
Technologies AS’s expense, for warranty service to be performed.

Notwithstanding the foregoing, Alere Technologies AS shall have no obligation to make repairs, replacements or corrections which result, in whole or in part, from
(i) an act of God or other unforeseen catastrophe, (ii) any error, omission or negligence of the Buyer, (iii) improper or unauthorized use of the Anion 2 Analyzer,
(iv)operating errors or the disregard of warnings and pre-cautions described in this Anion 2 Analyzer User Manual; (v) repairs performed to the Anion 2 Analyzer
by any person other than an authorized Alere Technologies AS service representative; (vi) use of the Anion 2 Analyzer in a manner for which it was not designed,
(vii) causes external to the Anion 2 Analyzer such as, but not limited to, power failure or electric power surges, or (viii) use of the Anion 2 Analyzer in combination
with equipment, components or software not supplied by Alere Technologies AS.

EXCEPT AS STATED IN THIS SECTION OF THE USER MANUAL, ALERE TECHNOLOGIES AS DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED,
WRITTEN OR ORAL, WITH RESPECT TO THE AFINION 2 ANALYZER, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. ALERE TECHNOLOGIES AS’S MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE AFINION 2 ANALYZER OR ITS USE, WHETHER BASED
UPON WARRANTY, CONTRACT, TORT OR OTHERWISE, SHALL NOT EXCEED THE ACTUAL PURCHASE PRICE PAID BY THE BUYER FOR THE AFINION 2
ANALYZER. IN NO EVENT SHALL ALERE TECHNOLOGIES AS BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT
LIMITED TO, LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES, ARISING HEREUNDER OR FROM THE SALE OF THE AFINION 2 ANALYZER.
THIS WARRANTY MAY NOT BE TRANSFERRED BY THE BUYER.

The acknowledgement of claims shall be reported to your Technical Care Specialist at 1.866.216.9505

30 | US

AFINION™ 2 User Manual

AFINIONTM 2 Analyzer

Analyzer

Size 200 mm W x 186 mm H x 328 mm D

Weight 3.4 kg

Display Standard LCD colour display with back light and integrated touch panel.

Resolution: 240 x 320 pixels. Visible area: 58 x 77 mm.

Camera 640 x 480 pixels

Capacity of result records 500 patient results and 500 control results

Capacity of operator list 1000 operators

Capacity of control lot database 100 control lots

SW update Via USB ash drive

Communication interface USB 2.0 High Speed, Ethernet 10/100 Mbps

Power supply

Power supply Separate AC to DC power supply. Double insulated.

Input 100-240 VAC, 50-60 Hz

Output 24 VDC ± 5% , 1.75 A, 42 W

Output connector 0.2 x 0.1 in. / 5.5 x 2.5 mm plug. Positive (+) on inner pin.

Operating conditions

Temperature 15-32°C (59-89°F)

Relative humidity 10-80%, non-condensing

Altitude Max 4000 MASL

Location Dry, clean, horizontal surface. Avoid direct sunlight.

Test cartridge temperature According to specications for the Anion Assay in use.

Storage and transport (in the original container)

Temperature -40 to 70ºC (-40 to 158°F)

Relative humidity 10-93 % at 40ºC

Technical Specications

Additional equipment

For information regarding recommended barcode reader, printer, the Anion Analyzer Cleaning Kit or USB ash drive, please call 1.866.216.9505.

AFINION™ 2 User Manual

US | 31

Gallery of Icons

The touch buttons and their function

Touching a button on the screen will activate the function of this button. All the touch buttons that may appear during operation of the Anion 2 Analyzer are
explained below by their function.

Start-up menu

Main menu

Conguration
menu

Patient sample mode Select patient sample mode.

Control mode Select control mode.

Main menu Enter Main menu (operator ID, patient records, control records and conguration menu).

QC lockout status

QC lockout status

QC lockout status

Operator logout
button

Patient records View patient result records. View, print or export patient results.

Control records View control result records. View, print or export control results.

Conguration menu Enter conguration menu (language, patient ID on/off, date/time and screen/volume).

Patient ID
conguration menu

Operator
conguration menu

Language setting Enter language conguration.

Enabled-unlocked
All controls are within the congured interval. It is possible to run patient tests for all assays.

Warning-unlocked
All controls are within the congured interval. When one or more of the assays has 10 % or
less of the congured interval remaining the warning icon will be displayed. It is possible to
run patient tests for all assays.

Expired-locked
One or more controls have expired according to the congured interval. Patient testing on the
expired assay has been locked.

Manual operator logout button.

Congure patient ID function.

Congure operator function.

Patient ID
conguration
menu

Operator
conguration
menu

Patient and
control records

Universial
buttons

Screen/Volume menu Congure screen and volume settings (screen contrast, screen adjustment and beeper volume).

Date/Time menu Enter date/time settings (date and time).

QC lockout
conguration menu

General settings menu Enter the general settings menu.

Patient ID disabled Patient ID disabled.

Patient ID enabled Patient ID enabled and required.

Operator ID
conguration

Automatic operator
logout

Operator list Manage operator list. View, add, edit and delete operators.

Print Print result on connected printer.

Result records export Export result records to connected USB ash.

Patient ID Enter patient ID.

Control ID Enter control ID.

Enter Enter and return to previous view.

Backspace Delete previous character.

Congure QC lockout function.

Congure operator ID function.

Congure number of minutes before automatic logout of operator.

32 | US

Increase Increase contrast/volume.

AFINION™ 2 User Manual

Menu Touch button Name Function

Decrease Decrease contrast/volume.

Scroll up View previous

Scroll down View next

Exit Exit current menu and return to previous screen view.

Accept Accept (a setting or a test result).

Abort Abort the test result or cancel operation.

Add button Add new operator or control lot.

Delete button Delete operator or control lot.

Edit button Edit QC lockout interval or operator ID.

Operator ID
conguration

Language
settings

Screen/Beeper
menu

Operator ID disabled Operator ID function is disabled.

Operator ID enabled Operator ID is required to be entered to run an Anion Test Cartridge

Operator ID enabled
with verication

Language Enter language conguration.

Screen alignment Enter screen alignment function.

Beeper volume Enter beeper volume setting.

Operator ID is required to be entered to run an Anion Test Cartridge. The operator ID is veri­ed against the analyzer operator list.

Gallery of Icons

Date/Time menu

General settings
menu

QC lockout
conguration
menu

Operator list Operator list export Export operator list from analyzer to USB ash.

QC lockout QC lockout disabled QC lockout is disabled for this test.

QC lockout
interval

Date Enter date setting.

Time Enter time setting.

Erase Erase all content and congurations.

Instrument network
settings

Connectivity settings Enter connectivity settings

QC lockout Enable/disable QC lockout function.

QC lockout interval Congure QC warning and lockout interval.

Control lot information View, add or delete control lots stored on analyzer.

Operator list import Import operator list from USB ash to analyzer.

QC lockout enabled One passed control run of either C I or C II is required to reset QC lockout interval.

QC lockout enabled Two passed control runs, C I and C II are required to reset QC lockout interval.

Interval by number of
patient tests

Interval by number of
hours

Enter analyzer network settings

QC reminder and lockout active after a congured set of patient tests.

QC reminder and lockout active after a congured set of hours.

AFINION™ 2 User Manual

US | 33

Gallery of Icons

Other symbols and signs

Other symbols, signs and abbreviations that may appear during operation of the Anion 2 Analyzer are explained below. These symbols or signs are only inform­ative and can not be activated like the buttons.

Symbol Meaning Appears when?

Wait! Hour-glass icon that appears in the start-up procedure.

Information code

Operator ID Icon illustrates the operator ID.

Patient ID Icon illustrates the patient ID.

Control ID Icon illustrates the control ID.

Connected

Quality control pass Control result is within acceptable range.

Quality control failed Control result is outside acceptable range.

Result is above
acceptable range

Result is below
acceptable range

C Control The letter C will appear on the screen when the control mode is selected.

O-ID Operator ID Abbreviation used in the patient and control records.

P-ID Patient ID Abbreviation used in the patient records.

C-ID Control ID Abbreviation used in the control records.

RUN# Run number

LOT# Lot number Abbreviation used in the patient and control records for the lot number of the test cartridge.

Icon used along with a code number [#] that corresponds to code specic information messages [#]
(see “Information codes and troubleshooting”).

The instrument is connected to the LIS/HIS/EMR server. When no symbol, the instrument is not connected to the
LIS/HIS/EMR server.

The displayed control result is above acceptable range.

The displayed control result is below acceptable range.

Abbreviation used in the patient and control records for the run number of the analysis. This numbering is reset each
day at midnight.

USER User Operator with user privileges.

SUPERVISOR Supervisor Operator with supervisor privileges.

34 | US

AFINION™ 2 User Manual

Symbols and Abbreviations

LOT

TEST CARTRIDGE

CONTROL C I

CONTROL C II

CLEANING KIT

N

CAN/CSA 22.2 No. 61010-1

The following symbols and abbreviations are used in the product labeling of the Anion 2 System.

Symbol/Abbreviation Explanation

The product conforms to all applicable EC
Directives and Regulations

IVD

In vitro diagnostic medical device

Catalogue number

Lot number

Serial number

Test cartridge

Symbol/Abbreviation Explanation

UL 61010-1

Conformity to the RoHS 2 directive

Conformity to the technical regulations for
EurAsian Conformity Mark

Conformity to the North American product
safety standards

Direct current

USB port

Control C I

Control C II

Cleaning kit

Waste electrical and electronic equipment
(WEEE)

Biological risks

Contents sufcient for ”n” number of tests

Expiration date

Storage temperature limitations

Manufacturer

Date of manufacture

Fragile, handle with care

Keep away from sunlight

Keep dry

Warnings and precautions

Consult the Anion User Instructions

Ethernet port

Double insulation

LED Light emitting diode

PC Personal computer

ID Identication

HIS Hospital information system

LIS Laboratory information system

LCD Liquid crystal display

AC Alternating current

DC Direct current

ASTM American Society for Testing and Materials

HL7 Health Level Seven

POCT1-A

EMR Electronic medical record

DHCP Dynamic host conguration protocol

IP Internet protocol

Point-of-Care Connectivity; approved
standard

AFINION™ 2 User Manual

US | 35

Alere Technologies AS

Kjelsåsveien 161
P.O. Box 6863 Rodeløkka
NO-0504 Oslo, Norway

www.alere.com

ISO 13485 certied company

© 2018 Abbott.All rights reserved.All trademarks referenced are trademarks
of either the Abbott group of companies or their respective owners.

1116752 Rev. A 2018/09