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
Legal Manufacturer
Address
Manufacturing Site
Agent Name
Agent Address
Product Name
Model
CFDA Certificate Number
Product Technical
Requirement Number
Structure and Components
Varian Medical Systems, Inc.
3100 Hansen Way, Palo Alto, CA, 94304 USA
911 Hansen Way, Palo Alto, CA, 94304 USA
Varian Medical Systems, China
No. 8, YunCheng Street, BDA, Beijing, China
Medical Linear Accelerator
TrueBeam, TrueBeam STx, Edge
CFDA (I) 20143324815
YZB/USA 6013-2014
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
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


Indications for Use in China
Contraindications in China
Service Agent in China:
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.
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 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
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