ON/OFF button: Turns the power to the Analyser on and off.
 Red and Green LEDs: Light emitting diodes (LEDs) that indicates whether the Analyser is busy or not.
 Touch screen: Allows you to communicate with the Analyser through touch buttons and messages.
 The lid: Covers and protects the cartridge chamber.
 Ethernet port for connection to LIS/HIS/EMR systems. Use shielded cable.
 USB-A: Connectors for printer, USB flash and barcode reader.
 Power input for power supply connection.

The Afinion™ 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 other main operative part of the Afinion™ 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 fingertips only on the touch screen. Do not use pens or other sharp instruments.

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 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.

Calibration

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

Cleaning and maintenance

No maintenance of the Afinion™ 2 Analyzer is required other than cleaning the exterior and cartridge chamber.

Cleaning the exterior of the Afinion™ 2 Analyzer should be performed whenever necessary.

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.

Please refer to the user manual for complete instructions.

Place your Afinion™ 2 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. Placement of Afinion™ 2 Analyzer should allow easy disconnection from the wall outlet at any time. 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
• Movement of the analyzer during processing of a test cartridge

Connecting power supply

• Connect the power cable to the power supply.
• Insert the plug from the power supply into the power socket in the back of the analyzer.
• Plug in the power supply to a wall outlet.

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

Connecting additional equipment

• Optional equipment, not provided with your Afinion™ 2 Analyzer are:
• External barcode reader – for reading barcoded sample or operator identification.
• Printer – for optional print out of test results.
• For additional information regarding barcode reader and printer specifications, please contact your local Afinion™ 2 supplier.

IMPORTANT

Please make sure the analyser is switched off at the end of your working day. Switch off the analyzer by pressing the ON/OFF button. The analyser can only be switched off if the cartridge chamber is empty and the door is closed

Before using your Afinion™ 2 Analyzer you should set the configuration according to your needs. To enter the Configuration menu, do the following:

Patient ID configuration

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.

Patient ID enable/disable

Touch  to enter lipid panel configuration menu. Touch the arrow in the window to view other options. Options: mmol/L (UK), mg/dL.

• Select which analytes you wish to see displayed.
• C - Total Cholesterol (not optional – always selected), HDL, LDL, Triglycerides, Non HDL, TC/HDL ratio.

Touch  to accept and return to the configuration menu.

Setting the 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.

Leave the unopened foil pouch on the bench for at least 15 minutes prior to analysis.

Allow the Afinion™ Test Cartridges to reach the recommended operating temperature before use.HbA1c – must reach a temperature of 18-30°C before use.

• HbA1c – must reach a temperature of 18-30°C before use.
• CRP – must reach a temperature of 15-30°C before use.
• Lipid Panel – must reach a temperature of 18-30°C before use.
• ACR – must reach a temperature of 20-30°C before use.

Consult the package insert that comes with each Afinion™ Test Kit for assay specific information.

Switch on your Afinion™ 2 Analyzer so it is ready for the day’s first analysis.

Enter the operator ID (optional).

The patient ID, control ID or Afinion™ Control Data can be entered before or during processing of the test cartridge in the analyzer.

Open the foil pouch. Grip the handle and remove the test cartridge from the pouch. Use the handle to avoid touching the optical reading area.

Discard the desiccant bag and foil pouch in suitable waste containers.

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 fit into the ID area.

A warm hand and good blood flow from the puncture site are essential to collect a good capillary sample.

• Always wear gloves.
• Select a puncture site from one of the middle fingers of either hand.
• If directed in the instructions for use: clean the finger with an alcohol swab.
• Dry thoroughly with gauze before pricking the finger.
• Use a lancet to prick the finger at the selected site.
• Squeeze the finger gently to obtain a drop of blood.
• If direted in the instructions for use: wipe away the first drop of blood.

Squeeze the finger for a second time until a large drop of blood forms, do not milk the finger. The puncture should provide a free flowing drop of blood. Excessive squeezing may lead to erroneous results.