Tabla De Contenido; Symbols And Abbreviations - Afinion 1115660 Manual Del Usuario

Afinion™ Data Connectivity Converter
User Manual Conformity to Directive
Afinion™ AS100 Analyzer equipped with Afinion™ Data Connectivity Converter (ADCC) meets all provisions in the European Directive 98/79/EC
on in vitro diagnostic medical devices, and the ADCC component is CE marked accordingly.
Safety standards
Afinion™ AS100 Analyzer equipped with 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
Afinion™ AS100 Analyzer equipped with 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 Intended use of the Afinion™ Data Connectivity Converter
3 Examining the package contents
4 Description of the Afinion™ Data Connectivity Converter
5 Installing the Afinion™ Data Connectivity Converter
5.1 Configuration of the ADCC
5.2 ADCC settings
5.3 Connecting ADCC
6 Web interface errors
7 Web interface ADCC software update
8 ADCC troubleshooting
8.1 LED status indicator signals
8.2 Confirm preparations
9 Testing procedures
10 Patient discretion
11 ADCC communication protocol data sheets
12 Maintenance and warranty
12.1 Cleaning and maintenance
12.2 Warranty
13 Disposal of the ADCC
14 Technical specifications
15 Third party software component
1 SYMBOLS AND ABBREVIATIONS
The following symbols and abbreviations are used in the product labelling and instructions for the Afinion™ Data Connectivity Converter. Please
consult the Afinion™ AS100 Analyzer User Manual and Package Insert that comes with each Afinion™ test kit for symbols and abbreviations for
the Afinion™ AS100 Analyzer system.
ADCC Afinion™ Data Connectivity Converter
SN Serial number
LOT Lot number
LED Light Emitting Diode
HIS Hospital Information System
LIS Laboratory Information System
ASTM American Society for Testing and Materials
HL7 Health Level Seven
EPR Electronic Patient Record
DHCP Dynamic Host Configuration Protocol
2
GB
US
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