Afinion AS100 Analyzer User Manual March 2008

Dear Customer, Congratulations on the purchase of your Afinion™ AS100 Analyzer. Upon arrival of your Afinion™ AS100 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 AS100 Analyzer.The recorded information will be of great value if and when a question is reported, or the desire to add a new Afinion™ test to your Analyzer arises.

Serial number (see label on the underside of the Analyzer or on the transport container) NOTE! The Analyzer must be turned off when the label on the underside is read.

Software records Date

Software version*

Afinion™ tests available

Upon receipt 1. SW upgrade 2. SW upgrade 3. SW upgrade 4. SW upgrade 5. SW upgrade * See display when you switch on the Analyzer (see “Automatic start-up procedure”, page 13).

Notes

Technical Support Call 1-877-4-Afinion or 1-877-423-4646. E-mail: [email protected] 09-38555

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AfinionTM AS100 Analyzer System Intended use The Afinion™ AS100 Analyzer System consists of the Afinion™ AS100 Analyzer and the Afinion™ Test Cartridges.The Afinion™ Analyzer System is designed for point-of-care testing and is for in vitro diagnostic use only.

CLIA Statements Waived Afinion™ tests This User Manual is valid for the Afinion™ tests waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA`88). A CLIA Certificate is needed to perform testing in a waived setting. If the laboratory modifies the Afinion™ test or Afinion™ AS100 Analyzer instructions, the test no longer meets the requirements for waived categorization. A modified test is considered to be highly complex and is subject to all applicable CLIA requirements.

Conformity to the IVD directive The Afinion™ AS100 Analyzer meets all provisions in the European directive 98/79/EC on In Vitro Diagnostic Medical Devices and is CE marked accordingly.

Safety standards The Afinion™ AS100 Analyzer is tested and conforms to the safety standards IEC/EN 61010-1, IEC/EN 61010-2-081 and IEC/EN 61010-2-101, and to the EMC standard IEC/EN 61326.

Axis-Shield PoC AS P.O. Box 6863 Rodeløkka NO-0504 Oslo, Norway ISO 9001 and ISO 13485 certified company

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TABLE OF CONTENTS

INTRODUCTION Intended use of the Afinion™ AS100 Analyzer System

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About this User Manual

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Examining the package contents

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ANALYZER SYSTEM DESCRIPTION Description of the Afinion™ AS100 Analyzer

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Description of the Afinion™ Test Cartridge

7

How to operate the Analyzer

8

How the Afinion™ AS100 Analyzer System works

9

Internal process control

9

Calibration

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GALLERY OF ICONS The icons and their function

10

Other symbols and signs

11

GETTING STARTED Locating your Analyzer

12

Connecting power supply

12

Connecting additional equipment

13

How to switch ON the Analyzer

13

Automatic start-up procedure

13

Setting the configuration

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How to switch OFF the Analyzer

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QUALITY CONTROL Why quality control testing?

19

Choosing control material

19

Handling and testing controls

19

Frequency of control testing

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TESTING PROCEDURES Operating precautions

20

Using the operator ID function

21

Using the patient ID function

22

Using the control ID function

23

Preparing for an Afinion™ analysis

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Collecting a specimen with the Test Cartridge

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Analyzing a patient sample

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Analyzing a control

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Viewing result records

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Table continues on next page.

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TABLE OF CONTENTS

INFORMATION CODES AND TROUBLESHOOTING When an information code appears Information messages caused by assay specific limitations

29

Error messages caused by sample or Test Cartridge failure

30

Error messages caused by Analyzer failure

31

Service information

31

MAINTENANCE AND WARRANTY Cleaning and maintenance

32

Disposal of the Analyzer

33

Software upgrade

33

Warranty

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TECHNICAL SPECIFICATIONS Afinion™ AS100 Analyzer

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Accessories

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SYMBOLS AND ABBREVIATIONS

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INTRODUCTION

Intended use of the Afinion™ AS100 Analyzer System Afinion™ AS100 Analyzer System, consisting of the Afinion™ AS100 Analyzer and the Afinion™ Test Cartridges, is for in vitro diagnostic use only. Afinion™ AS100 is a compact multi-assay analyzer for point-of-care testing. It is designed to analyze the Afinion™ Test Cartridges.The Afinion™ Analyzer System is easy to use, rapid and gives reliable and accurate results.

About this User Manual This User Manual will guide you through installation, operation and maintenance of your Afinion™ AS100 Analyzer.The User Manual also explains how the Analyzer works, describes the quality assurance system and assists you in troubleshooting. For analyzing patient samples or controls, please also read the test specific information given in the Package Inserts found in the Afinion™ test kits.The Quick Guides highlight the main steps of the test procedures and contains information on proper quality control routines. It is recommended that you become familiar with the user instructions before you start operating the 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 and Quick Guides for the specific 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 Afinion™ AS100 package unit includes: • Afinion™ AS100 Analyzer • Power cable • Power cord adapter, 24 volt power supply • Quick Guides for the available Afinion™ tests • User Manual • Installation video (CD-Rom) 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 Afinion™ AS100 Analyzer Figure 1 shows the main exterior parts of the Afinion™ AS100 Analyzer.

1 2 3 4 5 6

Figure 1 1 ON/OFF button: 2 Red and green LEDs: 3 Touch screen: 4 The lid: 5 Cooling ribs: 6 Connectors:

Turns the power to the Analyzer on and off. Light emitting diodes (LEDs) that indicate whether the Analyzer is busy or not. Allows you to communicate with the Analyzer through touch icons and messages. Covers and protects the cartridge chamber. Facilitate temperature control. For connecting to power cord adapter. Options for printer, barcode reader and/or PC connections.

Do not open the lid manually.

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ANALYZER SYSTEM DESCRIPTION

Description of the Afinion™ Test Cartridge The 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 and the sampling device labels have a unique color for each 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 Afinion™ Test Cartridge with its functional parts:

Left side

Right side

1b

1a 2 4 5

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6

3

Figure 2 1 Sampling device: 2 Capillary: 3 Reaction wells: 4 Handle: 5 Barcode label: 6 Optical reading area: 7 ID area:

For collection of patient sample or control. 1a - closed position 1b - lifted position Glass capillary to be filled with sample material. Contains all necessary reagents for one test. For correct finger grip. Contains assay and lot specific information for the Analyzer. Area for transmission measurement. Space for written or labeled sample identification.

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ANALYZER SYSTEM DESCRIPTION

How to operate the Analyzer The Afinion™ AS100 Analyzer has two main user interfaces, the touch screen and the cartridge chamber. The Analyzer is easily operated using the icons that appear on the screen. Only the icons you need to use at each operative step are displayed. When an icon is touched, it will turn grey and its function will be activated. Text messages that appear on the screen will help guide you through the testing procedure.The functions of the icons are explained in the “Gallery of icons”, page 10. The other main operative part of the 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 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.

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1 2 4

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

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 free and ready for use. A flashing green light indicates completion of an analysis. Sound signals A short beep indicates completion of an analysis.Two beeps indicate an information or error message.

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ANALYZER SYSTEM DESCRIPTION

How the Afinion™ AS100 Analyzer System works The 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, which then initiates the processing of the Test Cartridge.The sample and reagents are automatically transferred between the wells. A monochrome solid-state camera monitors the entire process. When the assay is completed, light-emitting diodes (LEDs) illuminate the final reaction area, which can be either a colored 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 29). If the Analyzer is unable to use the display, only the red LED will be flashing. 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 will not interrupt any Test Cartridge measurements. 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. If defects are detected (e.g. broken capillary, the cartridge is used past its expiration 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.

Calibration The 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. 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 results. Calibration by the operator is thus not required.

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GALLERY OF ICONS

The icons and their function Touching an icon on the screen will activate the function of this icon. All the icons that may appear during operation of the Afinion™ AS100 Analyzer are explained below by their function. Icon

Name

Function

Patient sample mode

Select patient sample mode.

Control mode

Select control mode.

Patient ID

Enter patient ID.

Control ID

Enter control ID.

Patient records

View patient result records.

Control records

View control result records.

Main menu

Enter main menu (operator ID, patient records, control records and configuration menu).

Operator ID

Enter operator ID.

Settings

Enter configuration menu (language, patient ID on/off, date/time and screen/beeper).

Language

Enter language selection.

Patient ID on/off

Enable/disable patient ID function.

Date/Time

Enter date/time settings (date and time).

Exit

Exit current menu and return to previous screen view.

Date

Enter date setting.

Time

Enter time setting.

Screen/Beeper

Enter screen and beeper settings (screen contrast, screen adjustment and beeper volume).

Screen contrast

Enter screen contrast setting.

Screen alignment

Enter screen alignment function.

Beeper volume

Enter beeper volume setting.

Accept

Accept (a setting or a test result).

Print

Print result on connected printer.

ON

Disable patient ID function (turns OFF when touched).

OFF

Enable patient ID function (turns ON when touched).

Table continued on next page.

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GALLERY OF ICONS

Icon

Name

Function

Enter

Enter and return to previous view.

Backspace

Delete previous character.

Increase

Increase contrast/volume.

Decrease

Decrease contrast/volume.

Scroll up

View next result in the patient or control records.

Scroll down

View previous result in the patient or control records.

Other symbols and signs Other symbols, signs and abbreviations that may appear during operation of the Afinion™ AS100 Analyzer are explained below.These symbols or signs are only informative and cannot be activated like the icons. Symbol

Meaning

Appears when?

Wait!

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

Information code

Icon used along with a code number [#] that corresponds to specific information or an error message (see “Information codes and troubleshooting”).

Operator ID

Icon illustrates the operator ID.

Patient ID

Icon illustrates the patient ID.

Control ID

Icon illustrates the control ID.

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

Abbreviation used in the patient and control records for the run number of the analysis.This numbering is reset each day at 24:00h.

LOT#

Lot number

Abbreviation used in the patient and control records for the lot number of the Test Cartridge.

[#]

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GETTING STARTED

Locating your Analyzer Place your Afinion™ AS100 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the Analyzer is located with sufficient surrounding airspace, at least 5 inches on each side. 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 • 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 4) 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 34.

1 2 3 4

Figure 4 1 Not in use 2 USB-A connectors for printer and/or barcode reader 3 RS-232 port for PC 4 Power input for power supply connection

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GETTING STARTED

Connecting additional equipment Optional accessories, not provided with your Afinion™ AS100 Analyzer are: • External barcode reader – for reading barcoded sample or operator identification. • Printer – for optional print out of test results. • PC – for data transfer to HIS or LIS systems. For additional information regarding the recommended barcode reader, printer, and PC connection please call 1-877-4-Afinion (1-877-423-4646) or email [email protected]. See figure 4 for correct connection of the external equipment. Connecting the equipment should be done while the Analyzer is switched off.

How to switch ON the Analyzer Switch on the Analyzer by pressing the ON/OFF button (Figure 1). An automatic start-up procedure will be initiated. Please wait. Do not open the lid manually.

Automatic start-up procedure Start-up menu

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2

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The automatic start-up procedure will be initiated shortly after the Analyzer has been switched on.The Analyzer's software version (X.XX) will appear in the upper left corner of the screen and a self-test will run for approximately 4 minutes.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. If the Analyzer fails during the start-up procedure, an information code will appear referring to a message given in the “Information codes and troubleshooting”, page 29.

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GETTING STARTED

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

Main menu

1 Touch main menu.

to enter

Configuration menu

2

3

Touch to enter configuration menu.

Select an item for configuration (see following pages).

The following items can be set from the configuration menu: • Language • Patient ID on/off • Date and time • Screen contrast, screen alignment and beeper volume To set these items, please comply with the following instructions.

Choosing language The default setting by the manufacturer is English. Other languages are available. Configuration menu

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1

2

3

Touch to enter language selection.

Touch the arrow in the window to view other languages. Scroll down until you find the preferred language.

Touch to accept and return to the configuration menu.

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Disabling or enabling patient ID function 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 (ON), the patient ID must be entered for each Test Cartridge to be analyzed. If the patient ID function is disabled (OFF), a run number will automatically replace the patient ID and be displayed in the upper left corner of the screen.This numbering is reset every 24hrs; each day at 00:00h. Disabling the patient ID function: Configuration menu

1

2

3

Touch to enter patient ID on/off option.

Touch to disable the patient ID function.

Touch to accept and return to the configuration menu.

1

2

3

Touch to enter patient ID on/off option.

Touch to enable the patient ID function.

Touch to accept and return to the configuration menu.

Enabling the patient ID function: Configuration menu

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GETTING STARTED

Setting date The correct date should always be set because the date and time for the analysis 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). Configuration menu

1

2

3

Touch to enter date/time settings.

Touch date setting.

to enter

Enter today's date. Touch to confirm and return to previous view.

Setting time The correct time should always be set because the date and time for the analysis are stored and displayed in the patient and control records.The time format is hh:mm, where hh is the hour from 00 to 23 and mm is minutes from 00 to 59. Configuration menu

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1

2

3

Touch to enter date/time settings.

Touch time setting.

to enter

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Enter time. Touch to confirm and return to previous view.

GETTING STARTED

Adjusting screen contrast The screen contrast can be adjusted. Configuration menu

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2

3

Touch to enter screen/beeper settings.

Touch to enter screen contrast setting.

Adjust screen contrast by touching or Touch to accept and return to previous view.

Aligning screen The screen must be realigned if the buttons do not respond accurately when touched. It is not necessary to align screen as a part of the initial configuration. Configuration menu

1

2

3

Touch to enter screen/beeper settings.

Touch to enter screen alignment function.

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 center of the screen. The previous screen view will automatically return.

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GETTING STARTED

Adjusting beeper volume One beep means that the test is completed and result displayed.Two beeps means that an information or error code is displayed.The beeper volume can be adjusted. If adjusted to a minimum, no beep will be heard. Configuration menu

1

2

3

Touch to enter screen/beeper settings.

Touch to enter beeper volume setting.

Adjust beeper volume by touching or Touch to accept and return to previous view.

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 until 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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QUALITY CONTROL

Why quality control testing? Quality control testing should be done to confirm that your Afinion™ AS100 Analyzer System is working properly and providing reliable results. Only when controls are used routinely and the values are within the acceptable ranges can accurate results for patient samples be assured.

Choosing control material Controls recommended by Axis-Shield should be used for quality control of your the Afinion™ AS100 Analyzer System.These control kits contain control materials with established acceptable ranges for the 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 20-28. 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 outside the acceptable limits, make sure that: - The control vial has not passed its expiry date. - The control vial has not passed its open vial expiry date. - The control vial and 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 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. Re-test the control material using a new control vial. Patient results must be declared invalid when controls do not perform as expected. Contact your customer service representative (1-877-4-Afinion or 1-877-423-4646) for advice before analyzing patient samples.

Frequency of control testing Controls should be analyzed: - With each new shipment of Afinion™ test kits. - With each new lot of Afinion™ test kits. - Users with a low frequency of testing should analyze controls at least every 30 days. - When training new operators in correct use of the Afinion™ AS100 Analyzer. - Anytime an unexpected test result is obtained. - After software upgrade of the Afinion™ AS100 Analyzer. The controls should always be analyzed if an unexpected test result is obtained (see the Afinion™ 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 benefit from establishing a quality control plan.The laboratory director should determine whether additional testing is appropriate for their laboratory. 09-38555

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