cobas
®
6800/8800 Systems
cobas p 680 instrument
Addendum
RFID readers
Publication version 1.0
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
2
Publication information
Revisions
This chapter contains an addition to the Publication
information and the Specification topic, which was
necessary due to missing information.
Operator’s Manuals and User Guides impacted
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
®
6800/8800 Systems Operator’s Manual Version 2.0
1.1 2.0 June 2015 cobas p 680 instrument Operator’s Manual Version 2.0
1.1.09 1.0 February 2017
cobas
®
6800/8800 Systems Operator’s Manual (for US only)
Version 1.0
1.1.10 2.1 January 2016
cobas
®
6800/8800 Systems User Guide Version 2.1
1.2 3.0 September 2016
cobas
®
6800/8800 Systems User Guide Version 3.0
1.2 3.0 August 2016 cobas p 680 instrument User Guide Version 3.0
y List of Operator’s Manuals and User Guides impacted
Software version Publication version Revision date Title
1.1 2.0 July 2015
cobas
®
6800/8800 Systems User Assistance Version 2.0
1.1 2.0 June 2015 cobas p 680 instrument User Assistance Version 2.0
1.1.09 1.0 February 2017
cobas
®
6800/8800 Systems User Assistance (USA) Version
1.0
1.1.10 2.1 January 2016
cobas
®
6800/8800 Systems User Assistance Version 2.1
1.2 3.0 September 2016
cobas
®
6800/8800 Systems User Assistance Version 3.0
1.2 3.0 August 2016 cobas p 680 instrument User Assistance Version 3.0
y List of User Assistances impacted
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
3
T
able of contents
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
cobas
®
6800/8800 Systems . . . . . . . . . . . . . . . . . . . . . 5
Publication information . . . . . . . . . . . . . . . . . . . . . . 5
Radio equipment specifications . . . . . . . . . . . . . . . 6
cobas p 680 instrument . . . . . . . . . . . . . . . . . . . . . . . . . 7
Publication information . . . . . . . . . . . . . . . . . . . . . . 7
Radio equipment specifications . . . . . . . . . . . . . . . 8
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
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) readers on
the cobas
®
6800/8800 Systems and the cobas p 680
instrument.
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
5
cobas
®
6800/8800 Systems
In this section
Publication information (5)
Radio equipment specifications (6)
Publication information
Instrument approvals
The cobas
®
6800/8800 Systems 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.
Directive 2011/65/EU of the European Parliament and of
the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.
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.
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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
Complies with the provisions of the applicable EU
directives.
For in vitro diagnostic use.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
6 cobas
®
6800/8800 Systems
Radio equipment specifications
The following modules contain radio equipment:
Issued by CSA Group for Canada and the US.
'Laboratory Equipment' is the product identifier as
shown on the type plate.
CUS
Monitor Transfer module Processing module
Frequency (MHz) 13.56 13.56 13.56
Maximum radio-frequency power (mW) < 100 < 200 < 200
Number of RFID readers 124
Number of antennas 1810
y Radio equipment
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
7
cobas p 680 instrument
In this section
Publication information (7)
Radio equipment specifications (8)
Publication information
Instrument approvals The cobas p 680 instrument 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.
Directive 2011/65/EU of the European Parliament and of
the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic
equipment.
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.
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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
Complies with the provisions of the applicable EU
directives.
For in vitro diagnostic use.
Roche Diagnostics
cobas® 6800/8800 Systems, cobas p 680 instrument · Publication version 1.0 · Addendum · RFID readers
8 cobas p 680 instrument
Radio equipment specifications
The following module contain radio equipment:
Issued by CSA Group for Canada and the US.
'Laboratory Equipment' is the product identifier as
shown on the type plate.
CUS
Monitor
Frequency (MHz) 13.56
Maximum radio-frequency power (mW) < 100
Number of RFID readers 1
Number of antennas 1
y Radio equipment
-
1
-
2
-
3
-
4
-
5
-
6
-
7
-
8
