afinion_2_user_manual_rev_b_june_2017.pdf
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Alere Afinion 2
™
EN
1116556, 1116597
User Manual
1116488 Rev. B 2017/06
Page 2
Symbols and Abbreviations
The following symbols and abbreviations are used in the product labelling and instructions for the Alere Afinion™ 2 system.
Symbol/Abbreviation
IVD
Explanation
Symbol/Abbreviation
Conformity to the RoHS 2 directive
In Vitro Diagnostic Medical Device
Conformity to the technical regulations for
EurAsian Conformity Mark
Catalogue number
LOT
Explanation
The product conforms to all applicable EC
Directives and Regulations
UL 61010-1
CAN/CSA 22.2 No. 61010-1
Lot number
Conformity to the North American product
safety standards
Serial number
Direct current
TEST CARTRIDGE
Test Cartridge
USB port
CONTROL C I
Control C I
Ethernet port
CONTROL C II
Control C II
Double insulation
CLEANING KIT
Cleaning kit
LED
Light Emitting Diode
Waste Electrical and Electronic Equipment
(WEEE)
PC
Personal Computer
Biological risks
ID
Identification
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
Keep away from sunlight
POCT1-A
Point-of-Care Connectivity; Approved
Standard
Keep dry
EMR
Electronic Medical Record
Warnings and precautions
DHCP
Dynamic Host Configuration Protocol
Consult the Alere Afinion user instructions
IP
Internet Protocol
N
Contents sufficient for ”n” number of tests
Expiry date
Storage temperature limitations
Manufacturer
Date of Manufacture
Fragile, handle with care
™
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Alere Afinion™ 2 User Manual
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Table of Contents
Table of contents
Introduction
Analyzer System Description
Intended use of the Alere Afinion™ 2 system
5
About this User Manual
5
Examining the package contents
5
Description of the Alere Afinion™ 2 analyzer
6
Description of the Alere Afinion™ Test Cartridge
6
How the Alere Afinion™ 2 system works
7
Internal process control
7
The analyzer self-test
7
The fail-safe mechanisms
7
External process control
Getting Started
Configuration
7
Patients ID
7
Operator ID
7
Quality Control lockout
7
Calibration
7
Installing your analyzer
8
Connecting power supply
8
Connecting additional equipment
8
Connectivity
8
How to switch ON the analyzer
9
How to switch OFF the analyzer
9
How to operate the analyzer
9
The Alere Afinion™ 2 menus
10
Setting the configuration
11
Patient ID configuration
11
Patient ID enable/disable
Operator configuration
Quality Control
11
12
Operator ID enable/disable
12
Operator login expiration
12
Operator list management
12
Choosing regional settings
13
Adjusting screen/beeper settings
13
Setting date and time
13
QC lockout configuration
14
General settings
15
Erase all contents and configuration
15
Analyzer network settings
15
Connectivity settings
16
Why quality control testing?
17
Choosing control material
17
Handling and testing controls
17
Frequency of control testing
17
Table of contents continues on next page
Alere Afinion™ 2 User Manual
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Table of Contents
Testing Procedures
Operating precautions
18
When operating the analyzer
18
When handling the Test Cartridge:
18
Preparing for an Alere Afinion™ 2 analysis
18
Collecting a sample
19
Analysing a patient/control sample
19
Using the operator ID function
20
Entering operator ID
20
Using the patient ID function
20
Entering patient ID
20
Using the control ID function
21
Entering Control ID
21
Using the QC lockout function
QC lockout status
21
Running controls with enabled QC lockout function
22
Patient and control results records
23
View, print and export patient and control results
Information Codes and
Troubleshooting
Maintenance and Warranty
21
23
When an information code appears
24
Information codes caused by test-specific limitations
24
Information codes caused by sample or Test Cartridge
25
Information codes and messages caused by analyzer failure
25
Other information codes
26
Service information
26
Cleaning and maintenance
27
Cleaning the exterior
27
Cleaning the cartridge chamber
27
Disposal of the analyzer
27
Software upgrade
27
Warranty
27
Technical Specifications
Alere Afinion™ 2 analyzer
28
Gallery of Icons
The touch buttons and their function
29
Other symbols and signs
31
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Alere Afinion™ 2 User Manual
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Introduction
Conformity to the European IVD directive and RoHS 2 directive (CE marking)
The Alere Afinion™ 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).
Conformity to North American product safety standards (cNus mark)
The Alere Afinion™ 2 analyzer has been tested and found to be in conformity with North American safety standards: See list of safety standards below.
Conformity to the technical regulations for EurAsian Conformity Mark (EAC mark)
The Alere Afinion™ 2 analyzer is certified according to the technical regulations for imports of machinery and equipment to the Eurasian Customs Union.
Safety standards
The Alere Afinion™ 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 Alere Afinion™ 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).
Intended use of the Alere Afinion™ 2 system
Alere Afinion™ 2 system, consisting of the Alere Afinion™ 2 analyzer and the Alere Afinion™ Test Cartridges, is for in vitro diagnostic use only. Alere Afinion™ 2 analyzer
is a compact multi-assay analyzer for point-of-care testing and is designed to analyse the Alere Afinion™ Test Cartridges.
About this User Manual
This User Manual will guide you through installation, operation and maintenance of your Alere Afinion™ 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 specific information given in the Package Inserts following the Alere Afinion™ test kits. The
Quick Reference 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™ 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 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™ 2 package unit includes:
•
•
•
•
Alere Afinion™ 2 analyzer
Power cable
Power supply, 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.
Alere Afinion™ 2 User Manual
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Page 6
Analyzer System Description
Description of the Alere Afinion™ 2 analyzer
Figure 1 shows the main exterior parts of the Alere Afinion™ 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 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 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 Alere Afinion™ 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 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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Alere Afinion™ 2 User Manual
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Analyzer System Description
How the Alere Afinion™ 2 system works
The Alere Afinion™ 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-specific 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 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 24-26).
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™ 2 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™ 2 operator functionality will, if configured, require the operators to login before testing. The functionality may also prevent unauthorized 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™ 2 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 17).
For more information regarding these functionalities, see “Configuration” page 10–16.
Calibration
The Alere 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 (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.
Alere Afinion™ 2 User Manual
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Getting Started
Installing your analyzer
Place your Alere 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 Alere 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 (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 Alere Afinion™ 2 analyzer. Any other power supplies or cables can damage the analyzer and may cause
possible hazards.
1
2
3
Figure 3
1 Ethernet port for connection to LIS/HIS/EMR systems. Use shielded cable.
2 USB-A connectors for printer, USB flash and barcode reader.
3 Power input for power supply connection
Connecting additional equipment
Optional equipment, not provided with your Alere 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 Alere Afinion™ 2 supplier.
Connecting the equipment should be done while the analyzer is switched 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
Alere Afinion™ 2 analyzer can reliably transfer test information to an information system. Use the Ethernet cable to interface the Alere Afinion™ 2 analyzer to an
information system. Alere Afinion™ 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 configuration. 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 configuration allows
for protection of connectivity settings. When operator configuration is set to operator ID with verification, the configuration of connectivity will only be available for
operators at supervisor level. For relevant information, see chapter “Operator configuration”, page 12.
When you export data that contains patient information, it is your responsibility to comply with your local regulations on protection of personal health information.
Alere Afinion™ 2 analyzer POCT1-A, ASTM and HL7 communication protocols are available at www.alere.com or by contacting your local Alere Afinion™ 2 supplier.
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Alere Afinion™ 2 User Manual
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Getting Started
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 24–26.
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.
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.
How to operate the analyzer
The Alere 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 functions of the touch buttons are explained in the section “Gallery of icons”, page 29–31.
The other main operative part of the Alere 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.
Figure 4
1
3
2
4
1 Text message
2 Touch buttons
3 The cartridge chamber
with a Test Cartridge
4 The lid in open position
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.
Alere Afinion™ 2 User Manual
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Page 10
Configuration
The Alere Afinion™ 2 menus
Start-up menu
Main menu
Patient ID configuration
menu
Regional settings
menu
Operator configuration
menu
Configuration menu
Date/Time
menu
QC lockout configuration
menu
General settings
menu
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Screen/beeper
menu
Alere Afinion™ 2 User Manual
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Configuration
Setting the configuration
Before using your Alere Afinion™ 2 analyzer you should set the configuration according to your needs. To enter the Configuration menu, do the following:
1
Start-up menu
Touch
2
Main menu
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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Page 12
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 with verification is enabled, analyzer 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 list management”, page 12.
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 list management
Touch
1
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.
Copy operator list
It is possible to copy an existing operator lists between analyzers using a USB flash drive. Insert USB flash in the analyzer USB port.
Touch
to export operator list from instrument to USB flash. Move USB to the new analyzer and touch
to import operator list. Any
existing operator list on the analyzer will be deleted.
2
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.
3
Configure the operator level
Select USER to configure user access.
Select SUPERVISOR to configure supervisor access.
Configure 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 configured to Operator ID with verification, configuration of the
analyzer will only be available to the supervisors.
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Alere Afinion™ 2 User Manual
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Configuration
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.
Adjusting screen/beeper settings
Touch
in the Configuration menu to enter the Screen/beeper menu.
Touch
to enter the Screen alignment setting.
Touch
to enter the Beeper volume setting.
Tap 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.
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 menu.
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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Page 14
Configuration
QC lockout configuration
Touch
in the Configuration menu to enter the QC lockout configuration menu.
Touch
1
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 for QC lockout configuration
Touch the arrow in the window to open the drop down menu.
Touch the assay to select.
2
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
to confirm and return to the previous view.
3
QC lockout interval
Select
Select
Touch
to configure QC lockout interval by number of runs.
to configure QC lockout interval by hours.
to enter/edit number of runs/hours to QC lockout.
displays the number of runs/hours configured in the QC lockout interval.
Touch
4
to confirm and return to the previous view.
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.
Touch
and either manually enter the Control Data or if a barcode reader is connected to the analyzer (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 23.
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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Alere Afinion™ 2 User Manual
Page 15
Configuration
General settings
Touch
in the Configuration menu to enter the General settings menu.
Touch
to erase all content and configurations.
Touch
to enter Instrument network settings.
Touch
to enter Connectivity settings.
Erase all contents and configurations
Touch
in General settings menu to erase all contents and configurations.
Touch
to erase all content and configurations.
Touch
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
Enter the IP Address. Touch
Enter the Gateway. Touch
Enter the Network mask. Touch
Enter the Hostname. Touch
Touch
to configure the network.
to confirm and continue to Gateway.
to confirm and continue to Network mask.
to confirm and return to Hostname.
to confirm and return to Instrument network settings view.
to accept and return to the General settings menu.
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”.
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.
IP address
Insert fixed 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
Alere Afinion™ 2 User Manual
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Page 16
Configuration
Connectivity settings
See Table 2 for description of the available Connectivity settings.
Touch
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
Touch
to enter page 2 of the configuration or
Touch
for HL7 only).
to return to the General settings menu
to enter Server IP and Port number, Receiving application (available for ASTM HL, ASTM LL and HL7 only) and Receiving facility (available
Enter the server IP address: Press
to continue to the Port number setting.
Enter the server port number setting: Touch
to continue to the Receiving application setting or to close the text input.
Enter the Receiving application setting: Press
to continue to the Receiving facility setting or to close the text input.
Use the button to select Patient ID as (available for HL7 only):
HIS Patient ID
Visit Number
Touch
to return to the General Settings menu
Table 2 Connectivity settings
Consult your network administrator and LIS/HIS/EMR administrator for required connectivity settings.
Protocol
Results
ASTM HL
ASTM High Level: The communication protocol is based on ASTM E 1394 - 97
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
Standard – Second Edition
Disabled
Data connectivity is disabled
Patient results only
Only patient results will be transferred to the LIS/HIS/EMR
Patient and quality
control
Both patient and QC 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
(ASTM HL, ASTM LL and HL7 only)
Receiving application name (0 – 30 characters)
Receiving Facility
(HL7 only)
Receiving facility name (0-30 characters)
Patient ID As
HIS Patient ID
(HL7 only)
Visit Number
(HL7 only)
For further information about the connectivity settings, see the Alere Afinion™ 2 data sheets for POCT1-A, ASTM and HL7 which can be obtained at www.Alere.com
or through your local Alere Afinion™ supplier.
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Alere Afinion™ 2 User Manual
Page 17
Quality Control
Why quality control testing?
Quality control testing should be done to confirm that your Alere Afinion™ 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 Alere Afinion™ 2 system. These control kits contain control materials with established
acceptable ranges for the Alere Afinion™ 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 Alere Afinion™ 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 18–23.
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 retest 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™ 2 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™ 2 analyzer for the first time.
• With each new shipment of Alere Afinion™ test kits.
• With each new lot of Alere Afinion™ test kits.
• If an unexpected patient test result is obtained.
• When training new personnel in the correct use of the Alere Afinion™ 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 analyse controls at least every 30 days.
• After software upgrade of the Alere Afinion™ 2 analyzer.
Alere Afinion™ 2 User Manual
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Page 18
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 24–26.
• 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 reuse 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 Afinion 2 analysis
TM
-
Allow the Alere Afinion™ Test Cartridges to reach the recommended operating temperature before use.
Switch on your Alere Afinion™ 2 analyzer so it is ready for the day’s first analysis.
Enter the operator ID (optional). See procedure on page 20.
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 20–23.
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.
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.
When first opened, the Test Cartridge has limited
stability.
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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Alere Afinion™ 2 User Manual
Page 19
Testing Procedures
Collecting a sample
•
•
•
•
The patient sample material and control material to be used is specific for each Alere Afinion™ test.
The length of the capillary in the sampling device, and thereby the sample volume, might also vary for the different Alere Afinion™ tests.
The time from filling 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 floor after the sample has been collected.
Consult the Package Insert that comes with each Alere Afinion™ test kit for assay specific information.
Examples:
1
2
3
Remove the sampling device from the Test
Cartridge.
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 fills completely. It is not possible to
overfill.
Do not wipe off the capillary.
Immediately and carefully replace the
sampling device into the Test Cartridge.
Use the handle to keep the Test Cartridge steady
against the table and pull the sampling device
straight up.
The time from filling the capillary until
analysing the Test Cartridge must be as
short as possible.
Avoid air bubbles and excess sample on the
outside of the capillary.
Analysing a patient/control sample
1
Touch
to enter the patient sample mode.
Touch
to enter the control mode.
The lid opens automatically.
2
3
Insert the Test Cartridge with the barcode label
facing left.
Close the lid manually.The analyzer will start
processing the Test Cartridge.
Be sure that the Test Cartridge is correctly placed
in the cartridge chamber.
The processing time depends on the test
in use.
A “C” in the upper left corner indicates that the
analyzer is in the control mode.
4
Touch
Touch
5
and enter the patient ID.
to confirm.
Touch
and enter the control ID or Alere
Afinion™ Control Data.
Touch
to confirm.
6
Record the result, then touch
If a printer is connected, touch
the result.
to accept.
to print
The lid opens automatically.
The result will be saved in the result records.
Entering the patient ID, control ID or Alere Afinion™
Control Data will not interrupt the processing.
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 Alere Afinion™ test kit for assay specific information.
Alere Afinion™ 2 User Manual
EN | 19
Page 20
Testing Procedures
Using the operator ID function
Entering operator ID
If enabled, the operator’s identification (ID) is required before processing an Alere Afinion™ Test Cartridge (see “Operator configuration”, page 12).
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 specific data
for this run (see “Patient and control results records”, page 23).
If configured to “enabled with verification” the operator ID entered is required to be present in the operator ID list (see “Operator configuration”, page 12).
Enter the operator ID by numbers and/or touch
operator ID can be entered.
Touch
to enter letters. If a barcode reader is connected to the analyzer, a bar coded
to confirm and return to previous view.
The operator will be automatically logged out according to the configuration (see “Operator configuration” page 12).
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 analysed. The
patient ID function can be disabled (see “Patient ID configuration”, page 11).
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
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
3
to confirm 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.
The P-ID 1 will be stored in the memory and displayed along with the other specific data for this run (see “Patient ID configuration” page 11). 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.
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Alere Afinion™ 2 User Manual
Page 21
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 specific 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 confirm 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 configured interval. If the interval expires, patient
testing for the assay will be locked. A passed control run must be performed according to configuration to reset the interval or to unlock the assay for patient testing.
A failed control run will disable patient testing (see “QC lockout configuration”, page 14).
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 configured interval. It is possible to run patient tests for all assays.
Warning-unlocked
All controls are within the configured interval. When one or more of the assays has 10 % or less of the configured 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 configured interval. Patient testing on the expired assay has been locked.
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Page 22
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 specified, 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 specified 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 Alere Afinion™ Control Data is required to be entered or previously stored in the instrument control
lot database. See “QC lockout configuration”, page 14.
1) The Alere Afinion™ 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 Alere Afinion™ 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 configured to QC lockout and the control lot number is not found in the Alere Afinion™ control database or the Alere Afinion™ 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
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
out configuration.
is displayed on the screen and the QC lockout interval is reset according to the QC lock-
If QC lockout is configured 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 (above or below the acceptable control range)
When a control result is not within the acceptable ranges specified 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
See “Handling and testing controls”, page 17.
22 | EN
or below
Alere Afinion™ 2 User Manual
the acceptable ranges.
Page 23
Testing Procedures
Patient and control results records
The patient and control results are stored in the memory of the Alere Afinion™ 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
2
Main menu
Touch
to enter patient results.
Touch
to enter control results.
The last patient result or control is displayed
To view more results touch
If a printer is connected, touch
or
to print the result.
Result records may be exported if an USB flash (FAT 32 formatted) is inserted to the Alere Afinion™ 2 USB port.
Touch
to export the results. The results will be stored on the USB in a .txt file for each assay tested on the Alere Afinion™ 2 analyzer.
These files 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.
Alere Afinion™ 2 User Manual
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Page 24
Information Codes and Troubleshooting
When an information code appears
Information codes that might appear during use of the Alere Afinion™ 2 analyzer refer to specific 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
Record the code number (#) and touch
to accept.
The lid opens automatically.
2
Remove the Test Cartridge.
If the Test Cartridge is not ejected, restart the analyzer.
Do not reuse the Test Cartridge.
3
Look up the possible cause from the table below, and take actions to solve the problem.
If the problem persists, contact your local Alere Afinion™ supplier (see “Service information” page 26).
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.
Information codes caused by test-specific limitations
[#]
Cause
Action to take
101
Hematocrit too low
Consult the Alere Afinion™ CRP or Lipid Panel Package Insert.
102
Hematocrit too high
Consult the Alere Afinion™ CRP or Lipid Panel Package Insert.
103
Hemoglobin too low
Consult the Alere Afinion™ HbA1c Package Insert.
104
Hemoglobin too high
Consult the Alere Afinion™ HbA1c Package Insert.
105
HbA1c too low
Consult the Alere Afinion™ HbA1c Package Insert.
106
HbA1c too high
Consult the Alere Afinion™ HbA1c Package Insert.
107
Creatine too high
Consult the Alere Afinion™ ACR Package Insert.
108
Blood in urine
Consult the Alere Afinion™ ACR Package Insert.
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Alere Afinion™ 2 User Manual
Page 25
Information Codes and Troubleshooting
Information codes caused by sample or Test Cartridge
[#]
Cause
Action to take
201
Insufficient sample volume:
- Empty capillary
- Air bubble in capillary
- Capillary incompletely filled
Repeat the test with a new sample and Test Cartridge.
Ensure that the capillary is completely filled with no air bubbles (see Package Insert for the Alere Afinion™ test in use).
202
Excess sample on the sampling
device exterior
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 Alere Afinion™ test in use).
203
Wrong sample material
Repeat the test with a new sample and Test Cartridge. Ensure that proper sample material is used (see Package Insert
for the Alere Afinion™ test in use, section “Specimen collection and storage”).
204
Coagulated sample
Repeat the test with a new sample and Test Cartridge.
The time from filling the capillary until analyzing the Test Cartridge should be as short as possible.
Hemolysed blood sample or
poor sample quality
Consult the Alere Afinion™ Package Insert.
Repeat the test with a new sample and Test Cartridge.
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.
205
Capillary cracked or damaged
Repeat the test with a new sample and Test Cartridge.
Inspect the sampling device before use and handle with care.
206
Barcode label not readable
(dirty or damaged)
Repeat the test with a new sample and Test Cartridge.
If the problem persists, restart the analyzer and run controls.
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 label is clean.
- Sampling device belongs to
another Alere Afinion™ 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
expiry date
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.
The date in the analyzer is
incorrectly set
Check the date in the analyzer to make sure it is set correctly. Repeat the test with a new sample and Test Cartridge.
210
Test Cartridge temperature
too low
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 Alere Afinion™ test in use).
211
Test Cartridge temperature
too high
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 Alere Afinion™ test in use).
212
Software upgrade is required
to run this test.
Contact your local supplier for assistance.
213
214
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.
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
(Alere Afinion™ HbA1c)
Consult the Alere Afinion™ HbA1c Package Insert. Repeat the test with a new sample and Test Cartridge.
217
Hemolysed blood sample or
poor sample quality
(Alere Afinion™ HbA1c)
Consult the Alere Afinion™ HbA1c Package Insert. Repeat the test with a new sample and Test Cartridge.
218
Condensation detected on
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
28
29
Start-up procedure failed
Contact your local supplier for assistance.
Self-test
error.
Analyzer
in nonoperative
mode
Analyzer failure
Restart analyzer. If the problem persists, contact your local Alere Afinion™ 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
Ensure that the operating temperature is within recommended range (15-32ºC).
Wait until the analyzer has cooled down. Repeat the test with a new sample and Test Cartridge.
304
Analyzer temperature is
too low
Ensure that the operating temperature is within recommended range for the Alere Afinion™ test in use (see Package
Insert). The analyzer temperature is displayed in the Start-Up menu (see page 9). Repeat the test with a new sample
and Test Cartridge.
Alere Afinion™ 2 User Manual
EN | 25