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cobas 5800

Roche cobas 5800, cobas 6800, cobas 8800, X800 Data Manager User manual

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cobas omni Utility Channel
Addendum
RFID reader/writer
Publication version 1.0
Roche Diagnostics
cobas omni Utiliy Channel · Publication version 1.0 · Addendum · RFID reader/writer
2
Publication information
Revisions
This chapter contains an addition to the Publication
information and the RFID reader/writer topic, which was
necessary due to missing information.
Operator’s Manuals and User Assistances impacted
Publication version Revision date Change description
1.0 September 2017 First version
y Revision history
Software version Publication version Revision date Title
1.1 2.0 July 2015 cobas omni Utility Channel Operator’s Manual Version 2.0
1.1 1.0 October 2015 cobas omni Utility Channel CE IVD SW 1.1 User Assistance
Version 1.0
1.2 2.0 August 2016 cobas omni Utility Channel CE IVD SW 1.2 User Assistance
Version 2.0
2.0 1.0 February 2017 cobas omni Utility Channel RUO Version 1.0
3.0 1.0 July 2017 cobas omni Utility Channel IVD SW 3.0 User Assistance
Version 1.0
y List of Operator’s Manuals and User Assistances impacted
Roche Diagnostics
cobas omni Utiliy Channel · Publication version 1.0 · Addendum · RFID reader/writer
3
T
able of contents
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
cobas omni Utility Channel . . . . . . . . . . . . . . . . . . . . . . 5
Publication information . . . . . . . . . . . . . . . . . . . . . . 5
About the RFID reader/writer . . . . . . . . . . . . . . . . . 6
Roche Diagnostics
cobas omni Utiliy Channel · Publication version 1.0 · Addendum · RFID reader/writer
4 Overview
Overview
Roche recommends that you familiarize yourself with the
new and/or revised content provided in this chapter.
q If you print these pages, Roche recommends
printing them single-sided. In this way, you can easily
insert the new and/or revised content in its appropriate
locations in the existing document.
This document describes the approvals and specifications
for the radio-frequency identification (RFID) reader/writer
for the cobas omni Utility Channel.
Roche Diagnostics
cobas omni Utiliy Channel · Publication version 1.0 · Addendum · RFID reader/writer
5
cobas omni Utility Channel
In this section
Publication information (5)
About the RFID reader/writer (6)
Publication information
Approvals
cobas omni Utility Channel Reagent Kit The cobas omni Utility Channel Reagent Kit meets the
requirements laid down in:
Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
The following marks demonstrate compliance:
Compliance is provided by means of the Declaration of
Conformity.
RFID reader/writer The RFID reader/writer provided with the
cobas omni Utility Channel meets the requirements laid
down in:
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the IVD directive 98/79/EC.
IVD
Complies with the Radio Equipment directive
2014/53/EU
Roche Diagnostics
cobas omni Utiliy Channel · Publication version 1.0 · Addendum · RFID reader/writer
6 cobas omni Utility Channel
Compliance is provided by means of the Declaration of
Conformity. To view the full text of the 2014/53/EU
declaration of conformity, go to the Roche DiaLog Global
Web Site (https://dialog1.roche.com/) and choose the
eLabDoc link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
About the RFID reader/writer
Specifications of radio equipment The following table summarizes the specifications for the
RFID reader/writer provided with the cobas omni Utility
Channel (TWN3 Legic NFC):
Frequency (MHz) 13.56
Maximum radio-frequency power (mW) < 100
Number of RFID readers 1
y Specifications of radio equipment
/