Alere Afinion Manual Del Usuario página 3

User Manual
US EN
User Manual Conformity to Directive
Alere Afinion AS100 Analyzer equipped with Alere Afinion Data Connectivity Converter (ADCC)
™
meets all provisions in the European Directive 98/79/EC on in vitro diagnostic 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 standards
Alere Afinion AS100 Analyzer equipped with Alere Afinion Data Connectivity Converter (ADCC)
has been tested and found to be in conformity with IIEC, 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 equipped with Alere Afinion Data Connectivity Converter (ADCC)
has been tested and found to be in conformity with EN 61326-1:2006 (Electrical equipment for
measurement, control, and laboratory use – EMC requirements), 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.
TABLE OF CONTENTS
1 SYMBOLS AND ABBREVIATIONS ....................................................................................... 2
2 INTENDED USE OF THE ALERE AFINION
3 EXAMINING THE PACKAGE CONTENTS ............................................................................ 3
4 DESCRIPTION OF THE ALERE AFINION
5 INSTALLING THE ALERE AFINION
5.1 Configuration of the ADCC .................................................................................................. 4
5.2 ADCC Settings ..................................................................................................................... 4
5.3 Connecting ADCC ................................................................................................................ 6
6 WEB INTERFACE ERRORS ................................................................................................. 6
7 WEB INTERFACE ADCC SOFTWARE UPDATE ................................................................... 7
8 ADCC TROUBLESHOOTING ............................................................................................... 8
8.1 LED status indicator signals ................................................................................................. 8
8.2 Confirm preparations ........................................................................................................... 9
9 TESTING PROCEDURES ..................................................................................................... 9
10 PATIENT DISCRETION ....................................................................................................... 10
11 CONNECTING THE ADCC TO A LIS/HIS SYSTEM ........................................................... 10
12 MAINTENANCE AND WARRANTY .................................................................................... 10
12.1 Cleaning and maintenance ................................................................................................ 10
12.2 Warranty ............................................................................................................................. 10
13 DISPOSAL OF THE ADCC ................................................................................................. 10
14 TECHNICAL SPECIFICATIONS .......................................................................................... 11
15 THIRD PARTY SOFTWARE COMPONENT ........................................................................ 11
™
DATA CONNECTIVITY CONVERTER ............. 3
™ DATA CONNECTIVITY CONVERTER ............... 3
™ DATA CONNECTIVITY CONVERTER ........................ 4
Alere Afinion Data Connectivity Converter
™
EN US
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