Abbott Afinion 2 User Manual
US User Manual
1116 554 , 1116 66 3
1116752 Rev. A 2018/09
Dear Customer,
Congratulations on the purchase of your Anion™ 2 Analyzer.
Upon arrival of your Anion 2 Analyzer we recommend that the serial number along with the software version be recorded in the table provided below. The
additional rows in the table are to be utilized if a software upgrade is performed on your Anion 2 Analyzer. The recorded information will be of great value if and
when a question is reported, or the desire to add a new Anion Test to your analyzer arises.
Serial number
(for serial number (SN), see label on the rear side of the analyzer or on the transport container)
Software records
Date
Upon receipt
1. SW upgrade
2. SW upgrade
3. SW upgrade
4. SW upgrade
5. SW upgrade
* See start-up menu when you power on the analyzer (see “How to power on the analyzer”, page 11).
Software version* Anion™ Tests available
Notes
_________________________________________________________________________________________________________________________________________________
_________________________________________________________________________________________________________________________________________________
Technical Support
Call 1.866.216.9505
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AFINION™ 2 User Manual
Intended use of the AFINION™ 2 System
Anion 2 System, consisting of the Anion 2 Analyzer and the Anion Test Cartridges, is for in vitro diagnostic use only. Anion 2 Analyzer is a compact multi-assay
analyzer for point-of-care testing and is designed to analyze the Anion Test Cartridges.
CLIA Statements - Waived Anion™ Tests
Anion HbA1c is waived under the Clinical Laboratory Improvement Amendment of 1988 (CLIA`88). A CLIA Certicate of Waiver is needed to perform testing in a
waived setting.
If the laboratory does not have a Certicate of Waiver, the Application for Certication (Form CMS-116), can be obtained at
https://www.cms.gov/cmsforms/downloads/cms116.pdf.
The form should be mailed to the address of the local State Agency of the State in which the laboratory resides
(https://www.cms.gov/CLIA/12_State_Agency_&_Regional_Ofce_CLIA_Contacts.asp).
If the laboratory modies the Anion Test or Anion 2 Analyzer system instructions, the test no longer meets the requirements for waived categorization. A modied
test is considered to be highly complex and is subject to all applicable CLIA requirements.
Conformity to directives and standards
European IVD directive and RoHS 2 directive (CE marking)
The Anion 2 Analyzer meets all provisions in the Directive 98/79/EC on in vitro diagnostic (IVD) medical devices and in the Directive 2011/65/EU on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2).
North American product safety standards (CNUS mark)
The Anion 2 Analyzer has been tested and found to be in conformity with North American safety standards. See list of safety standards below.
Safety standards
The Anion 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 Anion 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).
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AFINION™ 2 User Manual
Table of Contents
Table of contents
Introduction About this user manual 7
Examining the package contents 7
Analyzer System Description Description of the AFINION™ 2 Analyzer 8
Description of the Anion™ Test Cartridge 8
How the AFINION™ 2 System works 9
Internal process control 9
The analyzer self-test 9
The fail-safe mechanisms 9
External process control 9
Patients ID 9
Operator ID 9
Quality Control lockout 9
Calibration 9
Getting Started Installing your analyzer 10
Connecting power supply 10
Connecting additional equipment 10
Connectivity 10
How to power ON the analyzer 11
How to power OFF the analyzer 11
How to operate the analyzer 11
Conguration The AFINION™ 2 menus 12
Setting the conguration 13
Patient ID conguration 13
Patient ID enable/disable 13
Operator conguration 14
Operator ID enable/disable 14
Operator login expiration 14
Operator list management 14
Choosing language 15
Adjusting screen/beeper settings 15
Setting date and time 15
QC lockout conguration 16
General settings 17
Erase all contents and conguration 17
Analyzer network settings 17
Connectivity settings 18
Quality Control Why quality control testing? 19
Choosing control material 19
Handling and testing controls 19
Frequency of control testing 19
Table of contents continues on next page
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Table of Contents
Testing Procedures Operating precautions 20
When operating the analyzer 20
When handling the test cartridge 20
Preparing for an AFINION™ 2 Analysis 20
Collecting a sample 21
Analysing a patient/control sample 21
Using the operator ID function 22
Entering operator ID 22
Using the patient ID function 22
Entering patient ID 22
Using the control ID function 23
Entering control ID 23
Using the QC lockout function 23
QC lockout status 23
Running controls with enabled QC lockout function 24
Patient and control results records 25
View, print and export patient and control results 25
Information Codes and
Troubleshooting
Maintenance Cleaning and maintenance 29
Warranty 30
Technical Specications AFINION™ 2 Analyzer 31
Gallery of Icons The touch buttons and their function 32
Symbols and Abbrevations 35
When an information code appears 26
Information codes caused by test-specic limitations 26
Information codes caused by sample or test cartridge 27
Information codes and messages caused by analyzer failure 27
Other information codes 28
Service information 28
Cleaning the exterior 29
Cleaning the cartridge chamber 29
Disposal of the analyzer 29
Software upgrade 29
Additional equipment 31
Other symbols and signs 34
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AFINION™ 2 User Manual
Introduction
About this user manual
This user manual will guide you through installation, operation and maintenance of your Anion 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 specic information given in the package inserts following the Anion Test Kits. The quick
reference guides, available from your local Anion 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 Anion 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 specic Anion 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 Anion 2 package unit includes:
• Anion 2 Analyzer
• Power cable
• Power supply, 24 VDC
• User manual
• Quick guides for the available Anion Tests
If the package unit is found incomplete, please report missing items or shipping damage to your supplier. It is recommended to keep the shipping box in case of
later transportation of the analyzer.
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Analyzer System Description
Description of the AFINION™ 2 Analyzer
Figure 1 shows the main exterior parts of the Anion 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 Anion™ Test Cartridge
The Anion Test Cartridge is unique for each analyte to be measured, as the reagent composition, reagent volumes and the integrated devices are test specic.
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 Anion Test Cartridge with its functional parts:
Left side Right side
Figure 2
1 Sampling device: For collection of patient sample or control (1a - closed position, 1b - lifted position).
2 Capillary: Capillary to be lled with sample material.
3 Reaction wells: Contain all necessary reagents for one test.
4 Handle: For correct nger grip.
5 Barcode label: Contains assay and lot-specic information for the analyzer.
6 Optical reading area: Area for transmission measurement.
7 ID area: Space for written or labelled sample identication.
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AFINION™ 2 User Manual
Analyzer System Description
How the AFINION™ 2 System works
The Anion 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-specic 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 reected 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 specications. The self-test validates:
• Hardware and software integrity
• Test cartridge transport system
• Liquid transport system
• Camera vision system
If the self-test fails at any point, the red LED will start ashing and an information code will be displayed on the touch screen
(see “Information codes and troubleshooting”, page 26-28).
When the analyzer is powered on for a longer period, it will automatically restart once a day to ensure that a self-test is done regularly. This procedure does not
interrupt any analysis of the test cartridge.
The fail-safe mechanisms
Fail-safe mechanisms are included to secure safe processing. The integrated camera inspects the test cartridges initially before the process starts and during the
assay. If defects are detected (e.g. broken capillary, the cartridge is used past its expiry date), the test cartridge is rejected and an information code is displayed.
During processing vital functions and components (e.g. pumps, heater) are supervised. When problems are detected by the built-in safety mechanism, the process
will be aborted and an information code will be displayed.
External process control
Patient ID
The Anion 2 patient ID functionality will, if congured, allow up to four patient ID elds to be entered. The patient ID will be stored with each patient test result in
the result records.
Operator ID
The Anion 2 operator functionality will, if congured, require the operators to login before testing. The functionality may also prevent unauthorized operators to
login, perform tests and conguration. The operator ID will be stored with each test result in the result records.
Quality Control lockout
The Anion 2 QC lockout function allows you to congure the instrument to automatically enforce your local required frequency of control testing. If the required control
test has not been performed or the control result is outside the acceptable range, the instrument will disable patient testing for this assay. For manufacturer recommendations (see “Frequency of control testing” page 19).
For more information regarding these functionalities, see “Conguration” page 12–18.
Calibration
The Anion 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 specic calibration data are established for each lot of test cartridges and then stored in the barcode label (Figure 2). When the test cartridge enters the
analyzer, the integrated camera reads the barcode. The calibration data for the actual lot are transferred to the instrument and used for calculating the results.
Calibration by the operator is thus not required.
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Getting Started
Installing your analyzer
Place your Anion 2 Analyzer on a dry, clean, stable and horizontal surface. Make sure that the analyzer is located with sufcient surrounding airspace, at least 5
inches on each side. Placement of Anion 2 Analyzer should allow easy disconnection from the wall outlet at any time. Acclimate the analyzer to ambient operating
temperature (15-32°C, 59-89°F) before use.
The analyzer might be impaired by:
• Condensing humidity and water
• Heat and large temperature variations
• Direct sunlight
Connecting power supply
- Connect the power cable to the power supply.
- Insert the plug from the power supply into the power socket (Figure 3) in the back of the analyzer.
- Plug in the power supply to a wall outlet.
Only use the power supply and cable supplied with Anion 2 Analyzer. Any other power supplies or cables can damage the analyzer and may cause possible hazards.
Figure 3
1
1 Ethernet port for connection to LIS/HIS/EMR systems. Use shielded cable.
2
2 USB-A connectors for printer, USB ash and barcode reader.
3
3 Power input for power supply connection
• Vibrations (e.g. from centrifuges and dishwashers)
• Electromagnetic radiation
• Movement of the analyzer during processing of a test cartridge
Connecting additional equipment
Optional equipment, not provided with your Anion 2 Analyzer are:
• External barcode reader – for reading barcoded sample or operator identication.
• Printer – for optional print out of test results.
For additional information regarding barcode reader and printer specications, please contact your local Anion 2 supplier.
Connecting the equipment should be done while the analyzer is powered off.
All equipment connected to the USB and/or Ethernet ports must have double or reinforced insulation from mains to prevent the risk of electric shock.
Connectivity
Anion 2 Analyzer can reliably transfer test information to an information system. Use the Ethernet cable to interface the Anion 2 Analyzer to an information system.
Anion 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 conguration. 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 conguration allows for protection of
connectivity settings. When operator conguration is set to operator ID with verication, the conguration of connectivity will only be available for operators at
supervisor level. For relevant information, see chapter “Operator conguration”, page 14.
When you export data that contains patient information, it is your responsibility to comply with your local regulations on protection of personal health information.
Anion 2 Analyzer POCT1-A, ASTM and HL7 communication protocols are available at www.alere.com or by contacting your local Anion 2 supplier.
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AFINION™ 2 User Manual
GETTING STARTED
How to power ON the analyzer
1
Power on the analyzer by pressing the ON/OFF button (Figure1). An automatic start-up procedure will be initiated. Please wait.
Do not open the lid manually.
Getting Started
2
3
The automatic start-up procedure will be initiated shortly after the analyzer has been powered on. The red light on the top of the analyzer will
turn on, indicating that the analyzer is busy. The analyzer is ready for use when the start-up menu is displayed and the green indicator light
turns on.
Start-up menu
The analyzer’s software version (SW X.XX) will appear in the upper left corner of the Start-up menu screen. The temperature displayed in the
Start-up menu is the operating analyzer temperature. Make sure that the operating temperature is within the recommended range for your
Anion Test (see the package insert for the Anion Test).
If the analyzer fails during the start-up procedure, an information code will appear referring to a message given in the section “Information
codes and troubleshooting”, page 26-28.
How to power OFF the analyzer
Switch off the analyzer by pressing the ON/OFF button (Figure 1). The analyzer should be powered off after the end of a working day.
The analyzer can only be powered off when the cartridge chamber is empty and the lid is closed. If the ON/OFF button is pressed and the lid is open, the
message ”Close lid” will appear on the screen.
How to operate the analyzer
The Anion 2 Analyzer has two main user interfaces, the touch screen and the cartridge chamber. The analyzer is easily operated using the touch buttons that appear
on the screen. When a button is touched, its function will be activated. Text messages that appear on the screen will help guide you through the testing procedure.
The functions of the touch buttons are explained in the section “Gallery of icons”, page 32–34.
The other main operative part of the Anion 2 Analyzer is the cartridge chamber. The cartridge chamber is designed to receive the test cartridge in one orientation
only. The lid must be manually closed, but opens automatically. When a new test cartridge is placed in the chamber, manually closing the lid will initiate the analysis.
When the analysis is complete the lid will open automatically. The lid protects the cartridge chamber from dust, dirt, light and humidity during processing and when
the analyzer is not in use.
• The lid must be manually closed, but opens automatically. Do not open the lid manually.
• Use the ngertips only on the touch screen. Do not use pens or other sharp instruments.
Figure 4
1
2
Screen saver
The screen saver will turn on after 3 minutes, if the touch screen is not in use. To reactivate, touch the screen.
Light signals (the red and green LEDs)
The red diode is illuminated when the analyzer is busy. A ashing red light is seen when an information code is displayed. The green diode is illuminated when the
analyzer is ready for use. A ashing green light indicates completion of an analysis.
Sound signals
A short beep indicates completion of an analysis. Two beeps mean that an information code or message is displayed.
1 Text message
2 Touch buttons
3
3 The cartridge chamber
with a test cartridge
4
4 The lid in open position
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