1
Dear Customer,
Congratulations on the purchase of your Alere Afinion™ AS100 Analyzer.
Upon arrival of your Alere 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 Alere
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*
Alere Afinion™ tests available
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 10).
Notes
Technical Support
Call 1.866.216.9505
2
Alere Afinion
TM
AS100 Analyzer System
Intended use
Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for
point-of-care testing, designed to analyze the Alere Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer
of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another
electronic journal system. Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™
Data Connectivity Converter (ADCC), Alere Afinion™ Test Cartridges and Alere Afinion™ Controls is for in vitro diagnostic use only.
CLIA Statements
Waived Alere Afinion™ tests
Alere Afinion™ HbA1c is waived under the Clinical Laboratory Improvement Amendment
of 1988 (CLIA`88). A CLIA Certificate of Waiver is needed to perform testing in a waived setting.
If the laboratory does not have a Certificate of Waiver, the Application for Certification
(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_Office_CLIA_Contacts.asp).
If the laboratory modifies the Alere Afinion™ test or Alere Afinion™ AS100 Analyzer system 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 European IVD directive
The Alere 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
Alere Afinion™ AS100 Analyzer has been tested and found to be in conformity with IEC, UL, CAN/CSA-C22.2: 61010-1
(Safety requirements for electrical equipment for measurement, control, and laboratory use),
IEC 61010-2-081:2001 + A1 and IEC 61010-2-101:2002
(Particular requirements for in vitro diagnostic (IVD) medical equipment).
EMC standards
Alere Afinion™ AS100 Analyzer has been tested and found to be in conformity with
EN 61326-1:2006 (Electrical equipment for measurement, control, and laboratory use – EMC requirements) and EN 61326-2-6:2006
(In vitro diagnostic (IVD) medical equipment) and CFR 47 Telecommunications, Chapter I- FCC Part 15 – Radio Frequency Devices
– Subpart B: unintentional radiators.
Alere Technologies AS
Kjelsåsveien 161
P.O. Box 6863 Rodeløkka
NO-0504 Oslo, Norway
www.alere.com
ISO 9001 and ISO 13485 certified company
3
TABLE OF CONTENTS
Table of contents
INTRODUCTION
About this User Manual
5
Examining the package contents
5
ANALYZER SYSTEM DESCRIPTION
Description of the Alere Afinion™ AS100 Analyzer
6
Description of the Alere Afinion™ Test Cartridge
7
How the Alere Afinion™ AS100 Analyzer System works
8
Internal process control
8
The Analyzer self-test
8
The fail-safe mechanisms
8
External process control
8
Patients ID
8
Operator ID
8
Quality Control lockout
8
Calibration
8
GETTING STARTED
Installing your Analyzer
9
Connecting power supply
9
Connecting additional equipment
9
How to power ON the Analyzer
10
How to power OFF the Analyzer
10
How to operate the Analyzer
11
CONFIGURATION
Alere Afinion™ menus
12
Setting the configuration
13
Patient ID configuration
13
Patient ID enable/disable
13
Operator configuration
14
Operator ID enable/disable
14
Operator login expiration
14
Operator management
14
Copy operator list
15
Choosing language
15
Setting date and time
15
Adjusting screen/beeper volume settings
16
QC lockout configuration
17
Select assay type
17
QC lockout
17
QC lockout interval
17
Control lot database
17
QUALITY CONTROL
Why quality control testing?
18
Choosing control material
18
Handling and testing controls
18
Frequency of control testing
18
Table of contents continues on next page