Introduction; As100 Analyzer System; About This User Manual; Examining The Package Contents - Abbott ALERE AFINION AS100 Manual Del Usuario

Conformity to the European IVD directive and RoHS 2 directive (CE marking)
The Alere Afinion AS100 Analyzer/Alere Afinion AS100 Analyzer Connect 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).
Safety standard
Alere Afinion AS100 Analyzer/Alere Afinion AS100 Analyzer Connect has been tested and found to be in conformity with
IEC 61010-1:2001 (Safety requirements for electrical equipment for measurement, control, and laboratory use) and
IEC 61010-2-081:2001 + A1, IEC 61010-2-101:2002 (Particular requirements for in vitro diagnostic (IVD) medical
equipment).
EMC standards
Alere Afinion AS100 Analyzer/Alere Afinion AS100 Analyzer Connect 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).
Intended Use of the Alere Afinion
Alere Afinion AS100 Analyzer System, consisting of the Alere Afinion AS100 Analyzer or Alere Afinion AS100 Analyzer Connect
and the Afinion Test Cartridges, is for in vitro diagnostic use only. The Alere Afinion AS100 Analyzer Connect comprises of the Alere
Afinion AS100 Analyzer and the Alere Afinion Data Connectivity Converter.
Alere Afinion AS100 is a compact multi-assay analyzer for point-of-care testing. It is designed to analyse the Afinion Test
Cartridges. The Alere Afinion Analyzer System is easy to use, rapid and gives reliable and accurate results.

About this User Manual

This User Manual will guide you through installation, operation and maintenance of your Alere Afinion AS100 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
Afinion test kits. The Quick 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 AS100
Analyzer.
Some of the information in this User Manual is accompanied with a symbol that points you to the following particulars:
Operator's handling
Warnings and precautions
References to the Package Inserts for the specific 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 AS100 package unit includes:
• Alere Afinion AS100 Analyzer
• Power cable
• Mains adapter, 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.

AS100 Analyzer System

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Introduction

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