POINT OF CARE CENTER
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 soft-
ware 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.
Afinion™ tests available
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).
Call 1-877-4-Afinion or 1-877-423-4646. E-mail: email@example.com
(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.
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.
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.
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.
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
Intended use of the Afinion™ AS100 Analyzer System
About this User Manual
Examining the package contents
ANALYZER SYSTEM DESCRIPTION
Description of the Afinion™ AS100 Analyzer
Description of the Afinion™ Test Cartridge
How to operate the Analyzer
How the Afinion™ AS100 Analyzer System works
Internal process control
The icons and their function
Other symbols and signs
Locating your Analyzer
Connecting power supply
Connecting additional equipment
How to switch ON the Analyzer
Automatic start-up procedure
Setting the configuration
How to switch OFF the Analyzer
Why quality control testing?
Choosing control material
Handling and testing controls
Frequency of control testing
Using the operator ID function
Using the patient ID function
Using the control ID function
Preparing for an Afinion™ analysis
Collecting a specimen with the Test Cartridge
Analyzing a patient sample
Analyzing a control
Viewing result records
Table continues on next page.
When an information code appears
Information messages caused by assay specific limitations
Error messages caused by sample or Test Cartridge failure
Error messages caused by Analyzer failure
MAINTENANCE AND WARRANTY
Cleaning and maintenance
Disposal of the Analyzer
Afinion™ AS100 Analyzer