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    TrueBeam Instructions For Use-Addendum For Chinese Translations

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    Tengiz Lobzhanidze

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    TrueBeam Instructions For Use-Addendum For Chinese Translations

    Uploaded by

    Tengiz Lobzhanidze
    187 views6 pages

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    TrueBeam Instructions for Use-Addendum for Chinese Translations

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    Copyright:

    © All Rights Reserved
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    187 views6 pages

    TrueBeam Instructions For Use-Addendum For Chinese Translations

    Uploaded by

    Tengiz Lobzhanidze

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 6

    TrueBeam Instructions

    for Use
    Addendum for Chinese Translations
    TrueBeam®
    TrueBeam® STx
    Edge™ Radiosurgery System

    P1018151-001-A MAY 2016

    L4472 Rev 06
    Document ID P1018151-001-A

    Document Title TrueBeam Instructions for Use

    Abstract This document provides immediate release information specifically for, and must
    accompany, the Chinese translation of the TrueBeam Instructions for Use, which
    comprises user instructions and information for the using TrueBeam platforms with
    Version 2.5 TrueBeam™, TrueBeam STx, and Edge™ Radiosurgery System. This
    document is the English-language original.

    Manufacturers Varian Medical Systems, Inc.


    3100 Hansen Way
    Palo Alto, CA 94304-1038
    United States of America

    European Authorized Varian Medical Systems UK Ltd.


    Representative Oncology House
    Gatwick Road, Crawley
    West Sussex RH10 9RG
    United Kingdom

    Notice Information in this release note 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 release note 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 Varian Medical Systems, Oncology Systems products are designed and
    System Regulation manufactured in accordance with the requirements specified within this federal
    (cGMPs) 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 SVHC Disclosure The link to the current EU REACH SVHC disclosure statement is:
    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 and for Oncology (ICD-O), 3rd edition,
    Geneva, World Health Organization, 2000.
    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.

    2 TRUEBEAM INSTRUCTIONS FOR USE


    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 TrueBeam® is a registered trademark and Edge™ is a trademark of Varian Medical


    Systems, Inc.
    Windows® is a registered trademark of Microsoft Corporation.
    All other trademarks or registered trademarks are the property of their respective
    owners.

    Copyright © 2016 Varian Medical Systems, Inc.


    All rights reserved. Produced in the United States of America.

    TRUEBEAM INSTRUCTIONS FOR USE 3


    Contents

    About this Addendum ....................................................................................5


    Documents That Are Affected ................................................................. 5
    Chinese CFDA Registration Information ...................................................... 5
    Additional Information .............................................................................6
    Hardware Configuration ....................................................................... 6
    Accuracy Requirements ....................................................................... 6

    4 TRUEBEAM INSTRUCTIONS FOR USE


    About this Addendum
    The entire contents of this Instructions for Use Addendum (including cover, legal
    pages, and body contents) must accompany the Chinese translation of the Instructions
    for Use for the TrueBeam system.
    This Addendum is a controlled document so that changes to it can be tracked.

    Documents That Are Affected


    TrueBeam Instructions for Use—Addendum for Chinese Translations should
    accompany the Chinese translation (P1010302) of:
    TrueBeam Instructions for Use—P1005922
    which comprises user information and instructions for TrueBeam, TrueBeam STx, and
    Edge Radiosurgery Systems.
    Important: This Addendum is intended to accompany only the Chinese version
    (P1010302). Do not include the Addendum with the English original or any other
    translations of the Instructions for Use.

    Chinese CFDA Registration Information


    Legal Manufacturer Varian Medical Systems, Inc.
    Legal Manufacturer
    3100 Hansen Way, Palo Alto, CA, 94304 USA
    Address
    Manufacturing Site 911 Hansen Way, Palo Alto, CA, 94304 USA
    Agent Name Varian Medical Systems, China
    Agent Address No. 8, YunCheng Street, BDA, Beijing, China
    Product Name Medical Linear Accelerator
    Model TrueBeam, TrueBeam STx, Edge
    CFDA Certificate Number CFDA (I) 20143324815
    Product Technical
    YZB/USA 6013-2014
    Requirement Number
    This product consists of gantry, control console
    (TrueBeam Console), high-voltage pulse modulator
    (TrueBeam Modulator), treatment couch (Perfect Pitch
    6DoF (with 6DoF couch top); or TrueBeam Couch (with
    normal couch top)), MLCs (Millennium MLC 120 or
    HD120MLC), Conical Cone verification devices (including
    Barcode Conical Cone Verification Device, (BCCV or
    Structure and Components VVS), Integrated Conical Cone Verification and Interlock
    device (ICVI)), MV imaging device (DMI (with aS1200
    detector); or IDU (with aS1000 detector)), kV imaging
    device (Pascan 4030CB), Optical Surface Monitoring
    System (OSMS) and respiratory gating device (Optical
    Guidance System).
    For the listed product structures and components, Optical
    Surface Monitoring System (OSMS) is manufactured by

    TRUEBEAM INSTRUCTIONS FOR USE 5


    Vision RT Ltd. All others are manufactured by Varian
    Medical Systems, Inc.
    The product is intended to provide stereotactic
    radiosurgery treatment and radiotherapy treatment for
    lesions and tumors in the human body where radiation
    treatment is indicated.
    Indications for Use in China And, stereotactic radiosurgery treatment can be used for
    those benign diseases or some functional diseases for
    which clinical practices are mature and clinical benefit are
    confirmed; those indicated diseases shall be determined
    by prescribing doctors based on each specific situation.
    Contraindication of general radiotherapy shall be
    considered the contraindications of this product; specific
    Contraindications in China
    contraindications shall be determined by prescribing
    doctors based on each specific situation.
    Varian Medical Systems, China
    No.8, YunCheng Street, BDA, Beijing, China
    Tel：010-87858785
    Service Agent in China:
    Fax：010-87858961
    Postal Code：100176

    Additional Information
    Following are the requirements to carry out SRS treatments.

    Hardware Configuration
    Basic equipment required for treatment is the Stand/gantry, control console,
    modulator, and couch. In addition, the hospital must be equipped with at least one of
    the following beam-limiting devices:
    Multileaf Collimation Device (Millennium MLC 120)
    Multileaf Collimation Device (HD120MLC)
    Barcode conical collimator verification device (BCCV or VVS)
    Integrated cone verification and Interlock (ICVI)

    Accuracy Requirements
    ISO center accuracy (gantry and collimator) must be ≤0.5mm radius.

    6 TRUEBEAM INSTRUCTIONS FOR USE

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