Afinion AS100 Analyzer User Manual Rev A June 2015

Alere Afinion

™

AS100 Analyzer

GB

1116049, 1116050 1116435 Rev. A 2015/06

SYMBOLS AND ABBREVIATIONS

The following symbols and abbreviations are used in the product labelling and instructions for the Alere Afinion™ AS100 Analyzer System.

Symbol/Abbreviation

Explanation Conformity to the European directive 98/79/EC on in vitro diagnostic medical devices In Vitro Diagnostic Medical Device Catalogue number Lot number Serial number Test Cartridge

CONTROL C I

Control C I

CONTROL C II

Control C II

CLEANING KIT

Cleaning kit Waste Electrical and Electronic Equipment (WEEE) Contents sufficient for ”Σ” number of tests Expiry date (year-month) Storage temperature limitations Manufacturer Fragile, handle with care Keep away from sunlight Keep dry Operator’s handling Warnings and precautions Consult the Alere Afinion™ user instructions Direct current USB port

IOIOI

Serial port Double insulation

LED

Light Emitting Diode

PC

Personal Computer

ID

Identification

HIS

Hospital Information System

LIS

Laboratory Information System

LCD

Liquid Crystal Display

AC

Alternating Current

DC

Direct Current

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TABLE OF CONTENTS

Table of contents INTRODUCTION

ANALYZER SYSTEM DESCRIPTION

Intended use of the Alere Afinion™ AS100 Analyzer System

5

About this User Manual

5

Examining the package contents

5

Description of the Alere Afinion™ AS100 Analyzer

6

Description of the Alere Afinion™ Test Cartridge

7

How the Alere Afinion™ AS100 Analyzer System works

8

Internal process control

8

The Analyzer self-test

8

The fail-safe mechanisms

8

External process control

GETTING STARTED

CONFIGURATION

8

Operator ID

8

Quality Control lockout

8

Calibration

8

Installing your Analyzer

9

Connecting power supply

9

Connecting additional equipment

9

How to switch ON the Analyzer

10

How to switch OFF the Analyzer

10

How to operate the Analyzer

11

Alere Afinion™ menues

12

Setting the configuration

13

Patient ID configuration

13

Patient ID enable/disable Operator configuration

QUALITY CONTROL

8

Patients ID

13 14

Operator ID enable/disable

14

Operator login expiration

14

Operator management

14

Copy operator list

15

Choosing regional settings

15

Setting date and time

15

Adjusting screen/beeper settings

16

General settings menu

16

QC lockout configuration

17

Select assay type

17

QC lockout

17

QC lockout interval

17

Control lot database

17

Why quality control testing?

18

Choosing control material

18

Handling and testing controls

18

Frequency of control testing

18 Table of contents continues on next page

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TABLE OF CONTENTS

TESTING PROCEDURES

Operating precautions

19

When handling the Test Cartridge:

19

Preparing for an Alere Afinion™ analysis

19

Collecting a sample

20

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

24

QC lockout status

24

Running controls with enabled QC lockout function

25

Failed (Above or below the acceptable control range)

25

View, print and export patient and control results

MAINTENANCE AND WARRANTY

TECHNICAL SPECIFICATIONS

GALLERY OF ICONS

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25

Passed Patient and control results records

INFORMATION CODES AND TROUBLESHOOTING

19

When operating the Analyzer

26 26

When an information code appears

27

Information codes caused by test-specific limitations

27

Information codes caused by sample or Test Cartridge

28

Information codes and messages caused by Analyzer failure

28

Other information codes

29

Service information

29

Cleaning and maintenance

30

Disposal of the Analyzer

30

Software upgrade

30

Warranty

30

Alere Afinion™ AS100 Analyzer

31

Additional equipment

31

The touch buttons and their function

32

Other symbols and signs

34

INTRODUCTION

Conformity to the IVD directive

The Alere Afinion™ AS100 Analyzer/Alere Afinion™ AS100 Analyzer Connect meets all provisions in the European directive 98/79/EC on In Vitro Diagnostic Medical Devices and is CE marked accordingly. Alere Afinion™ AS100 Analyzer is EC certified for self-testing. The CE mark is accompanied by the Notified Body number (0120).

Safety standard

Alere Afinion™ AS100 Analyzer/Alere Afinion™ AS100 Analyzer Connect has been tested and found to be in conformity with IEC 61010-1:2001 (Safety requirements for electrical equipment for measurement, control, and laboratory use) and IEC 61010-2-081:2001 + A1, IEC 61010-2-101:2002 (Particular requirements for in vitro diagnostic (IVD) medical equipment).

EMC standards

Alere Afinion™ AS100 Analyzer/Alere Afinion™ AS100 Analyzer Connect has been tested and found to be in conformity with EN 61326-1:2006 (Electrical equipment for measurement, control, and laboratory use – EMC requirements) and EN 61326-2-6:2006 (In vitro diagnostic (IVD) medical equipment).

Intended use of the Alere Afinion™ AS100 Analyzer System Alere Afinion™ AS100 Analyzer System, consisting of the Alere Afinion™ AS100 Analyzer or Alere Afinion™ AS100 Analyzer Connect and the Alere Afinion™ Test Cartridges, is for in vitro diagnostic use only. The Alere Afinion™ AS100 Analyzer Connect comprises of the Alere Afinion™ AS100 Analyzer and the Alere Afinion™ Data Connectivity Converter. Alere Afinion™ AS100 is a compact multi-assay analyzer for point-of-care testing. It is designed to analyse the Alere Afinion™ Test Cartridges. The Alere Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results. When in agreement with national regulations, Alere Afinion™ AS100 Analyzer can be used for self-testing by lay users under professional supervision in a pharmacy. This intended use of the instrument is only applicable in combination with Alere Afinion™ test kits with the corresponding intended use. Alere Afinion™ AS100 Analyzer is not intended for use in a home environment.

About this User Manual This User Manual will guide you through installation, operation and maintenance of your Alere Afinion™ AS100 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 specific information given in the Package Inserts following the Alere Afinion™ test kits. The Quick Guides, available from your local Alere Afinion™ 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 Alere Afinion™ AS100 Analyzer. Some of the information in this User Manual is accompanied with a symbol that points you to the following particulars: Operator’s handling Warnings and precautions References to the Package Inserts for the specific Alere Afinion™ 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 Alere Afinion™ AS100 package unit includes: • • • •

Alere Afinion™ AS100 Analyzer Power cable Mains adapter, 24 VDC User Manual

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.

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ANALYZER SYSTEM DESCRIPTION

Description of the Alere Afinion™ AS100 Analyzer Figure 1 shows the main exterior parts of the Alere Afinion™ AS100 Analyzer.

1 2 3 4 5 6

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

Cooling ribs:

Facilitate temperature control.

6

Connectors:

For connecting to mains power supply. Options for printer, barcode reader and/or HIS or LIS connections.

Do not open the lid manually.

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ANALYZER SYSTEM DESCRIPTION

Description of the Alere Afinion™ Test Cartridge The Alere Afinion™ Test Cartridge is unique for each analyte to be measured, as the reagent composition, reagent volumes and the integrated devices are test specific. The Test Cartridge label has a colour unique for the test. The Test Cartridges are separately packed in foil pouches to protect the chemicals 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 re-used. Figure 2 illustrates an Alere Afinion™ Test Cartridge with its functional parts:

Left side

Right side

1b

1a 2 4 5

7

6

3

Figure 2 1

Sampling device:

For collection of patient sample or control. 1a - closed position 1b - lifted position

2

Capillary:

Capillary to be filled with sample material.

3

Reaction wells:

Contain all necessary reagents for one test.

4

Handle:

For correct finger grip.

5

Barcode label:

Contains assay and lot-specific information for the Analyzer.

6

Optical reading area:

Area for transmission measurement.

7

ID area:

Space for written or labelled sample identification.

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ANALYZER SYSTEM DESCRIPTION

How the Alere Afinion™ AS100 Analyzer System works The Alere Afinion™ AS100 Analyzer 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-specific information is obtained from the barcode label (Figure 2). When the Test Cartridge enters the Analyzer, the integrated camera reads the barcode. 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 reflected 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 specifications. 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 flashing and an information code will be displayed on the touch screen (see “Information codes and troubleshooting”, page 27). When the Analyzer is switched 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 Alere Afinion™ patient ID functionality will, if configured, allow up to four patient ID fields to be entered. The Patient ID will be stored with each patient test result in the result records.

Operator ID

The Alere Afinion™ operator functionality will, if configured, require the operators to login before testing. The functionality may also prevent un-authorized operators to login, perform tests and configuration. The operator ID will be stored with each test result in the result records.

Quality Control lockout

The Alere Afinion™ QC lockout function allows you to configure 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 18). For more information regarding these functionalities (see “Configuration” page 12–17).

Calibration The Alere Afinion™ AS100 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 specific 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.

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GETTING STARTED

Installing your Analyzer Place your Alere Afinion™ AS100 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the Analyzer is located with sufficient surrounding airspace, at least 10 cm on each side. Acclimate the Analyzer to ambient operating temperature (15-32°C) before use. The Analyzer might be impaired by: • Condensing humidity and water • Heat and large temperature variations • Direct sunlight

• Vibrations (e.g. from centrifuges and dishwashers) • Electromagnetic radiation (e.g.from mobile phones) • Movement of the Analyzer during processing of a Test Cartridge

Connecting power supply - Connect the power cable to the power cord adapter. - Insert the plug from the power cord adapter into the power socket (Figure 3) in the back of the Analyzer. - Plug in the power cord to a wall outlet. Always use the correct supply voltage. The power supply voltage must match the information quoted in the section “Technical specifications”, page 31.

Figure 3 1 Not in use 2 USB-A connectors for printer, USB flash and/or barcode reader 3 RS-232 port for connection to HIS or LIS systems. 4 Power input for power supply connection

Connecting additional equipment Optional equipment, not provided with your Alere Afinion™ AS100 Analyzer are: • External barcode reader – for reading barcoded sample or operator identification. • Printer – for optional print out of test results. • Alere Afinion™ Data Connectivity Converter - For data transfer to HIS or LIS systems (see “Additional equipment”, page 31). For additional information regarding the barcode reader, printer, and connection to HIS or LIS systems, please contact your local Alere Afinion™ supplier. Connecting the equipment should be done while the Analyzer is switched off.

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GETTING STARTED

How to switch ON the Analyzer 1

Switch 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.

2

The automatic start-up procedure will be initiated shortly after the Analyzer has been switched 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.

3

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 Alere Afinion™ test (see the Package Insert for the Alere Afinion™ 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 27–29.

How to switch OFF the Analyzer Switch off the Analyzer by pressing the ON/OFF button (Figure 1). The Analyzer should be switched off after the end of a working day. Please note: • When the power is turned off, a closing down procedure is initiated. The cartridge carriage will move to a safe position and the display will be active a few seconds while the Analyzer shuts down. The Analyzer can be switched off, or the power supply disconnected, without loss of stored results. • The Analyzer can only be switched 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.

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GETTING STARTED

How to operate the Analyzer The Alere Afinion™ AS100 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 Alere Afinion™ AS100 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 fingertips only on the touch screen. Do not use pens or other sharp instruments.

3

Figure 4 1 Text message 2 Touch buttons 3 The lid in open position 4 The cartridge chamber with a Test Cartridge

1

2 4

Screen saver

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

Light signals (the red and green LEDs)

The red diode is illuminated when the Analyzer is busy. A flashing red light is seen when an information code is displayed. The green diode is illuminated when the Analyzer is ready for use. A flashing 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.

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CONFIGURATION

The Alere Afinion™ Menus Start-up menu

Main menu

Configuration menu

Patient ID configuration menu

Operator configuration menu

QC lockout configuration menu

Regional settings menu

Date/Time Menu

Screen and volume menu

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CONFIGURATION

Setting the configuration Before using your Alere Afinion™ AS100 Analyzer you should set the configuration according to your needs. To enter the configuration menu, do the following:

1

Start-up menu

2

Main menu

Touch

Touch

3

to enter main menu.

to enter configuration menu.

Configuration menu Select an item for configuration (see following pages).

Patient ID configuration Patient ID enable/disable The patient identification (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 analysed. 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 configuration 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 configuration menu.

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CONFIGURATION

Operator configuration Touch

in the configuration menu to enter the operator configuration menu.

Operator ID enable/disable Touch

in operator configuration 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 verification.

· To enable this function at least one supervisor is required to be present in the operator list. · When operator ID verified is enabled, instrument configuration 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 management. Touch

to accept and return to the configuration menu.

Operator login expiration Touch

in the operator configuration 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 configured number of minutes after ended test. Touch

to confirm and return to previous view.

Operator management Touch

1

2

in operator configuration menu to enter operator list. Touch

to add new operator.

Touch desired operator ID and touch

to delete or

to edit the highlighted operator.

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.

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CONFIGURATION

3

Configure the operator level: 1) User 2) Supervisor Configure tests accessible. Check of the test accessible for this operator. Touch

to return and edit the operator ID.

Touch IDs.

to accept and store new operator in the operator list. The operator list can store 500 operator

Supervisors will be marked with * in the operator list. When instrument is configured to Operator ID verified, configuration of the instrument will only be available to the supervisors.

Copy operator list

It is possible to copy operator lists between instruments using a USB flash drive. Insert USB flash in instrument USB port. Touch to export operator list from instrument to USB flash. Move USB to new to import operator list. Any existing operator list on the instrument will be instrument and touch deleted.

Choosing Regional settings Touch

1

2

in the configuration menu to enter the regional settings menu. Regional settings. Touch

to enter language selection.

Touch

to enter HbA1c units.

Touch

to enter ACR units.

Touch

to enter Lipid Panel configuration menu.

Touch the arrow in the window to view other options. Scroll down until you find the preferred option. Configuring the Lipid Panel, touch the box or the test name to enable/disable. Touch

to accept and return to the configuration menu.

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

1

2

in the configuration menu to enter date/time setting. Touch

to enter date setting.

Touch

to enter time setting.

Enter today’s date or time. Touch

to confirm and return to the previous view.

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CONFIGURATION

Adjusting screen/beeper settings Touch

in the configuration menu to enter the screen/beeper settings.

The screen contrast can be adjusted. Touch

to enter the screen contrast setting.

Touch

to enter the screen alignment setting.

Touch

to enter the beeper volume setting.

Adjust the screen contrast by touching Touch

or

to confirm and return to previous view.

Tap the cross-hair object (+) in the upper left corner using a blunt pencil to be precise. Repeat for the object appearing in the lower right corner and in the centre of the screen. The previous screen view will automatically return.

Adjust the beeper volume by touching Touch

or

to confirm and return to the previous view.

General settings menu Touch

in the configuration menu to enter the general settings menu.

Touch

to erase all content and configurations.

All data will be permanently erased.

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CONFIGURATION

QC lockout configuration Touch

1

in the configuration menu to enter the QC lockout setting menu. Touch

to configure QC lockout for the assay selected.

Touch

to configure QC lockout interval.

Touch

to view/add/delete stored control lots in the control lot database.

Select assay type Touch the arrow in the window to open the drop down menu to select the assay type. Touch the assay to select.

2

QC lockout Select

to disable the QC lockout function. No QC runs will be required for this assay

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

3

to confirm and return to the previous view.

QC lockout interval Select

to configure QC lockout interval by number of runs.

Select

to configure QC lockout interval by hours.

Touch

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

displays the number of runs/hours configured in the QC lockout interval. to confirm and return to the previous view. Touch

4

Control lot database To add a control to the control lot database the Alere Afinion™ Control Data is required. The Alere Afinion™ Control Data is a numeric data string which contains all lot specific data: • Alere Afinion™ control lot number • Control type (assay) • Control level (C I or C II)

• Control expiry date • Acceptable control range • CRC (check sum to validate the previous data)

The Alere Afinion™ Control Data and its accompanying barcode is found in the Alere Afinion™ Control kit package insert. If the Alere Afinion™ Control Data is not available, contact your local supplier. and either manually enter the Control Data or if a barcode reader is connected to the Analyzer Touch (recommended), scan the barcode. The Alere Afinion™ 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.

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QUALITY CONTROL

Why quality control testing? Quality control testing should be done to confirm that your Alere Afinion™ AS100 Analyzer System is working properly and providing 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 Alere Afinion™ AS100 Analyzer System. These control kits contain control materials with established acceptable ranges for the Alere Afinion™ AS100 Analyzer 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 Alere Afinion™ AS100 Analyzer 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 19–26. 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 expiry date. - The control vial has not passed the declared stability for opened vials. - The control vial and Alere Afinion™ 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 re-test the control material. If one or more control results are still out of range: - Analyse a control sample from a new vial. If the advice above is followed and the control results are still outside the stated acceptable ranges, contact your local Alere Afinion™ supplier for assistance before proceeding to analyse patient samples.

Frequency of control testing It is recommended that controls are analysed: • When starting up an Alere Afinion™ AS100 Analyzer for the first time. • With each new shipment of Alere Afinion™ test kits. • With each new lot of Alere Afinion™ test kits. • If the Test Cartridges have not been stored in accordance with the instructions. • If an unexpected patient test result is obtained. • When training new personnel in the correct use of the Alere Afinion™ AS100 Analyzer 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 analyse controls at least every 30 days. • After software upgrade of the Alere Afinion™ AS100 Analyzer.

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TESTING PROCEDURES

Operating precautions When operating the Analyzer: • Use your fingertip 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 27–29. • Do not move the Analyzer when a Test Cartridge is being processed.

When handling the Test Cartridge: • Do not use Test Cartridges after the expiry 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 re-use any part of the Test Cartridge. Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.

Preparing for an Alere AfinionTM analysis -

Allow the Alere Afinion™ Test Cartridges to reach the recommended operating temperature before use. Switch on your Alere Afinion™ Analyzer so it is ready for the day’s first analysis. Enter the operator ID (optional). See procedure on page 22. The patient ID, control ID or Alere Afinion™ 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 Alere Afinion™ test kit for assay specific information.

Tear strip

1

2

3

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.

Inspect the Cartridge. Do not use the Test Cartridge if it is damaged or if loose desiccant particles are found on the Test Cartridge.

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.

When first opened, the Test Cartridge has limited stability.

Use the handle to avoid touching the optical reading area.

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

If a barcode reader is connected to the Analyzer, a barcoded patient ID, control ID or Alere Afinion™ Control Data can be entered.

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