Alere Afinion ™ as100 Analyzer us



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1115175

1116227 Rev. A   2014/07



Alere Afinion

 

AS100 Analyzer



 

US

 



  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



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





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