Intuitive Surgical SRFAX01 RFID Module User Manual Intuitive Surgical

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Document ID	3196406
Application ID	iGATM37jfsWCcG0CgaHVSg==
Document Description	Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	6.4kB (80044 bits)
Date Submitted	2016-11-15 00:00:00
Date Available	2017-05-14 00:00:00
Creation Date	2016-08-03 17:19:47
Producing Software	Microsoft® Word 2010
Document Lastmod	2016-08-03 17:19:47
Document Title	Intuitive Surgical
Document Creator	Microsoft® Word 2010
Document Author:	Art Gwerder

TITLE: Installation Instructions for RFID
Module SRFAX01
DOCUMENT: 818388-01
REVISION: A
PAGE: 1 of 2
The module will be used with the host device (model PS1098) and as such, required
testing and approval is completed. Use with any other host device may or may not
require additional testing and approval. Consult Hardware Compliance Engineering for
assistance.
The RFID module (Model: SRFAX01) includes the sterile adapter mount (P/N 318325),
the distal PSM nose (P/N 318331), and the SRFA PCA (P/N 352350).
The module will be labeled to identify FCC ID (2AAZF-SRFAX01), IC ID (11508ASRFAX01), and Model (SRFAX01). The label is P/N 510176-01, having white
background with black text, and must be attached in a manner such that it will remain
fastened to the device during the expected life of the product. The “minimum size and
font” is that the text must be legible. Label will be applied on the sterile adapter mount
near the SRFA location. It will not be visible when installed on host location. This is
acceptable because the approval ID information will be marked on the rear vent panel of
the host device.
The intentional radiator symbol will be included with the approval ID information (refer to
880175-02) on the host device, as required per EN60601-1-2. This marking will be
readily visible to the user of the host device without the use of tools.
Note: Statements below that are within quotation marks have fixed wording.
FCC
The host product must be labeled with the following:
“Contains FCC ID: 2AAZF-SRFAX01”
The host product manual must include following statements:
“This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.”
Changes or modifications, not expressly approved by Intuitive Surgical, may void
the user’s authority to operate the equipment. (Note: the wording for this
statement is not fixed)
CONFIDENTIAL AND PROPRIETARY – Intuitive Surgical Inc.
Prior to use, use ACCS to verify that this is the current revision
Template File: 853244 Form_Template Rev D.doc
TITLE: Installation Instructions for RFID
Module SRFAX01
DOCUMENT: 818388-01
REVISION: A
PAGE: 2 of 2
Industry Canada
The host product must be labeled with the following (in English and French):
“Contains IC: 11508A-SRFAX01”
The host product manual must include following statements (in English and French):
“Under Industry Canada regulations, this radio transmitter may only operate
using an antenna of a type and maximum (or lesser) gain approved for the
transmitter by Industry Canada. To reduce potential radio interference to other
users, the antenna type and its gain should be so chosen that the equivalent
isotropically radiated power (eirp) is not more than necessary for successful
communication.”
“This device complies with Industry Canada license-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.”
"Conformément à la réglementation d'Industrie Canada, cet émetteur radio peut
fonctionner uniquement à l'aide d'une antenne de type et de gain maximum (ou
moindre) approuvés pour l'émetteur par Industrie Canada. Pour réduire le risque
d'interférence aux autres utilisateurs, le type d'antenne et son gain doivent être
choisis afin que la puissance isotrope rayonnée équivalente (PIRE) n‘excède pas
celle nécessaire à une communication réussie ".
"Cet appareil est conforme au(x) standard(s) des CNR d’Industrie Canada pour
appareils radio exempt(s) de licence . Son fonctionnement est soumis aux deux
conditions suivantes: (1) ce dispositif ne doit pas causer d'interférences nuisibles,
et (2) cet appareil doit accepter toute interférence reçue, y compris les
interférences qui peuvent provoquer un fonctionnement indésirable ".
CONFIDENTIAL AND PROPRIETARY – Intuitive Surgical Inc.
Prior to use, use ACCS to verify that this is the current revision
Template File: 853244 Form_Template Rev D.doc

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Page Count                      : 2
Language                        : en-US
Tagged PDF                      : Yes
Title                           : Intuitive Surgical
Author                          : Art Gwerder
Creator                         : Microsoft® Word 2010
Create Date                     : 2016:08:03 17:19:47-07:00
Modify Date                     : 2016:08:03 17:19:47-07:00
Producer                        : Microsoft® Word 2010

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