Varian Medical Systems VCDT711N Visual Coaching Device (VCD) User Manual Wireless Compliance Statements

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Document ID	2840854
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Document Description	UserManual_Safety.pdf
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Date Submitted	2015-12-14 00:00:00
Date Available	2015-12-14 00:00:00
Creation Date	2015-11-11 04:02:26
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Document Title	Wireless Compliance Statements
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Wireless Compliance
Statements
Visual Coaching Device
13485
P1015323-001-A
DECEMBER 2015
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Document ID
P1015323-001-A
Document Title
Wireless Compliance Statements–Visual Coaching Device
Abstract
This document provides wireless compliance statements for the Visual Coaching
Device (VCD) as used for the following product:
■ Respiratory Gating for Scanners 1.1 (or higher)
This publication is the English-language original.
Manufacturer
Varian Medical Systems, Inc.
3100 Hansen Way
Palo Alto, CA 94304-1038
United States of America
European
Authorized
Representative
Varian Medical Systems UK Ltd.
Oncology House
Gatwick Road, Crawley
West Sussex RH10 9RG
United Kingdom
Notice
Information in this user guide is subject to change without notice and does not
represent a commitment on the part of Varian. Varian is not liable for errors
contained in this user guide or for incidental or consequential damages in
connection with furnishing or use of this material.
This document contains proprietary information protected by copyright. No part of
this document may be reproduced, translated, or transmitted without the express
written permission of Varian Medical Systems, Inc.
FDA 21 CFR 820
Quality System
Regulations
(cGMPs)
Varian Medical Systems, Oncology Systems products are designed and
manufactured in accordance with the requirements specified within this federal
regulation.
ISO 13485
Varian Medical Systems, Oncology Systems products are designed and
manufactured in accordance with the requirements specified within the ISO 13485
quality standard.
CE
Varian Medical Systems, Oncology Systems products meet the requirements of
Council Directive MDD 93/42/EEC.
EU REACH
The link to the current EU REACH SVHC disclosure statement can be found at
SVHC Disclosure http://www.varian.com/us/corporate/legal/reach.html
HIPAA
Varian’s products and services are specifically designed to include features that help
our customers comply with the Health Insurance Portability and Accountability Act
of 1996 (HIPAA). The software application uses a secure login process, requiring a
user name and password, that supports role-based access. Users are assigned to
groups, each with certain access rights, which may include the ability to edit and
add data or may limit access to data. When a user adds or modifies data within the
database, a record is made that includes which data were changed, the user ID, and
the date and time the changes were made. This establishes an audit trail that can be
examined by authorized system administrators.
WHO
ICD-O codes and terms used by permission of WHO, from:
■ International Classification of Diseases for Oncology, (ICD-O) 3rd edition,
Geneva, World Health Organization, 2000.
Wireless Compliance Statements
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ICD-10 codes and terms used by permission of WHO, from:
■ International Statistical Classification of Diseases and Related Health Problems,
Tenth Revision (ICD-10). Vols 1–3, Geneva, World Health Organization, 1992.
Electronic labeling
This symbol on the label indicates that the Instructions for Use for the
corresponding product are available at www.MyVarian.com. Access the Instructions
for Use in electronic form by logging in with your assigned MyVarian user
credentials.
In compliance with EU Commission Directive No 207/2012, Varian will send EU
customers a free printed copy of the Instructions for Use within 7 days. Use the
“Paper Document Request” form provided on the Varian webpage to order your
copy.
CAUTION: US Federal law restricts this device to sale by or on the
order of a physician.
Trademarks
Varian® and VMS® are trademarks of Varian Medical Systems, Inc.
Microsoft® is a registered trademark of Microsoft Corporation.
All other trademarks or registered trademarks are the property of their respective
owners.
Copyright
© 2015 Varian Medical Systems, Inc.
All rights reserved. Produced in Switzerland.
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Contents
CHAPTER 1 USA
FCC
.....................................................................................................................................5
.........................................................................................................................................................................5
CHAPTER 2 CANADA
RSS-Gen / CNR-Gen
CHAPTER 3 JAPAN
........................................................................................................................... 6
.......................................................................................................................................... 6
................................................................................................................................ 7
Japanese Radio Law and Japanese Telecommunications Business Law Compliance
...................... 7
INDEX .......................................................................................................................................................... 8
Wireless Compliance Statements
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Chapter 1 USA
FCC
FCC 15.105
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
■ Reorient or relocate the receiving antenna.
■ Increase the separation between the equipment and receiver.
■ Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
■ Consult the dealer or an experienced radio/TV technician for help.
FCC 15.19
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 of the device.
FCC 15.21
NOTICE: Changes or modifications made to this equipment not expressly approved by
Varian Medical Systems may void the FCC authorization to operate this equipment.
FCC 2.1091, FCC 2.1093, FCC OET Bulletin 65
For body worn operation, this device has been tested and meets FCC RF exposure
guidelines when used in close proximity to the human body.
Chapter 1 USA
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Chapter 2 Canada
RSS-Gen / CNR-Gen
RSS-Gen 8.4
This device complies with Industry Canada’s licence-exempt RSSs. 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 of the device.
CNR-Gen 8.4
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux
appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions
suivantes:
1. l’appareil ne doit pas produire de brouillage;
2. l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, même
si le brouillage est susceptible d’en compromettre le fonctionnement.
Wireless Compliance Statements
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Chapter 3 Japan
Japanese Radio Law and Japanese Telecommunications
Business Law Compliance
This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese
Telecommunications Business Law (電気通信事業法). This device should not be
modified (otherwise the granted designation number will become invalid).
Chapter 3 Japan
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma
Index
Canada 6
CNR-Gen 6
FCC 5
Japan 7
RSS-Gen 6
USA 5
Wireless Compliance Statements
Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma

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