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

Varian Medical Systems, Inc. Visual Coaching Device (VCD) Wireless Compliance Statements

Contents

UserManual_Safety.pdf

Wireless ComplianceStatementsVisual Coaching Device13485P1015323-001-A DECEMBER 2015Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)
Document ID P1015323-001-ADocument Title Wireless Compliance Statements–Visual Coaching DeviceAbstract This document provides wireless compliance statements for the Visual CoachingDevice (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 WayPalo Alto, CA 94304-1038United States of AmericaEuropeanAuthorizedRepresentativeVarian Medical Systems UK Ltd.Oncology HouseGatwick Road, CrawleyWest Sussex RH10 9RGUnited KingdomNotice Information in this user guide is subject to change without notice and does notrepresent a commitment on the part of Varian. Varian is not liable for errorscontained in this user guide or for incidental or consequential damages inconnection with furnishing or use of this material.This document contains proprietary information protected by copyright. No part ofthis document may be reproduced, translated, or transmied without the expresswrien permission of Varian Medical Systems, Inc.FDA 21 CFR 820Quality SystemRegulations(cGMPs)Varian Medical Systems, Oncology Systems products are designed andmanufactured in accordance with the requirements specied within this federalregulation.ISO 13485 Varian Medical Systems, Oncology Systems products are designed andmanufactured in accordance with the requirements specied within the ISO 13485quality standard.CE Varian Medical Systems, Oncology Systems products meet the requirements ofCouncil Directive MDD 93/42/EEC.EU REACHSVHC DisclosureThe link to the current EU REACH SVHC disclosure statement can be found at hp://www.varian.com/us/corporate/legal/reach.htmlHIPAA Varian’s products and services are specically designed to include features that helpour customers comply with the Health Insurance Portability and Accountability Actof 1996 (HIPAA). The software application uses a secure login process, requiring auser name and password, that supports role-based access. Users are assigned togroups, each with certain access rights, which may include the ability to edit andadd data or may limit access to data. When a user adds or modies data within thedatabase, a record is made that includes which data were changed, the user ID, andthe date and time the changes were made. This establishes an audit trail that can beexamined by authorized system administrators.WHO ICD-O codes and terms used by permission of WHO, from:■International Classication of Diseases for Oncology, (ICD-O) 3rd edition,Geneva, World Health Organization, 2000.2Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)Wireless Compliance Statements
ICD-10 codes and terms used by permission of WHO, from:■International Statistical Classication of Diseases and Related Health Problems,Tenth Revision (ICD-10). Vols 1–3, Geneva, World Health Organization, 1992. Electronic labelingThis symbol on the label indicates that the Instructions for Use for thecorresponding product are available at www.MyVarian.com. Access the Instructionsfor Use in electronic form by logging in with your assigned MyVarian usercredentials.In compliance with EU Commission Directive No 207/2012, Varian will send EUcustomers 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 yourcopy.CAUTION: US Federal law restricts this device to sale by or on theorder 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 respectiveowners.Copyright © 2015 Varian Medical Systems, Inc.All rights reserved. Produced in Swierland.Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)3
ContentsCHAPTER 1 USA .....................................................................................................................................5FCC .........................................................................................................................................................................5CHAPTER 2 CANADA ...........................................................................................................................6RSS-Gen / CNR-Gen .......................................................................................................................................... 6CHAPTER 3 JAPAN ................................................................................................................................ 7Japanese Radio Law and Japanese Telecommunications Business Law Compliance ...................... 7INDEX .......................................................................................................................................................... 84Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)Wireless Compliance Statements
Chapter 1 USAFCCFCC 15.105This equipment has been tested and found to comply with the limits for a Class Bdigital device, pursuant to part 15 of the FCC Rules. These limits are designed toprovide reasonable protection against harmful interference in a residentialinstallation. This equipment generates, uses and can radiate radio frequency energyand, if not installed and used in accordance with the instructions, may cause harmfulinterference to radio communications. However, there is no guarantee thatinterference will not occur in a particular installation. If this equipment does causeharmful interference to radio or television reception, which can be determined byturning the equipment o and on, the user is encouraged to try to correct theinterference 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 dierent from that to which thereceiver is connected.■Consult the dealer or an experienced radio/TV technician for help.FCC 15.19This device complies with part 15 of the FCC Rules. Operation is subject to thefollowing two conditions:1. This device may not cause harmful interference; and2. This device must accept any interference received, including interference thatmay cause undesired operation of the device.FCC 15.21NOTICE: Changes or modifications made to this equipment not expressly approved byVarian Medical Systems may void the FCC authorization to operate this equipment.FCC 2.1091, FCC 2.1093, FCC OET Bulletin 65For body worn operation, this device has been tested and meets FCC RF exposureguidelines when used in close proximity to the human body.Chapter 1 USADraft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)5
Chapter 2 CanadaRSS-Gen / CNR-GenRSS-Gen 8.4This device complies with Industry Canada’s licence-exempt RSSs. Operation issubject to the following two conditions:1. This device may not cause harmful interference; and2. This device must accept any interference received, including interference thatmay cause undesired operation of the device.CNR-Gen 8.4Le présent appareil est conforme aux CNR d’Industrie Canada applicables auxappareils radio exempts de licence. L’exploitation est autorisée aux deux conditionssuivantes:1. l’appareil ne doit pas produire de brouillage;2. l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique subi, mêmesi le brouillage est susceptible d’en compromere le fonctionnement.6Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)Wireless Compliance Statements
Chapter 3 JapanJapanese Radio Law and Japanese TelecommunicationsBusiness Law ComplianceThis device is granted pursuant to the Japanese Radio Law (電波法) and the JapaneseTelecommunications Business Law (電気通信事業法). This device should not bemodied (otherwise the granted designation number will become invalid).Chapter 3 JapanDraft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)7
IndexCCanada 6CNR-Gen 6FFCC 5JJapan 7RRSS-Gen 6UUSA 58Draft (ast1444303527385 / Authoring:formal review / 11-Nov-2015 04:01 PST / asteinma)Wireless Compliance Statements

Navigation menu