GammaMedplus Ix User Guide

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GM10 UG Book.

book Page i Tuesday, March 24, 2009 11:22 AM

GammaMedplus iX ™

User Guide

including the GammaMedplus 3/24 iX

and MammoSource iX

P/N GM11020140
Rev 1.1 – March 2009
GM10 UG Book.book Page ii Tuesday, March 24, 2009 11:22 AM

Abstract The GammaMedplus iX User Guide (P/N GM11020140) provides GammaMedplus iX system users with
basic instructions for using the afterloader control software with the GammaMedplus iX and
GammaMedplus 3/24 iX high dose rate remote afterloaders.
Help Desk Support If you cannot find information in this user guide, you may contact us at one of the toll free numbers
available in your area:
Australia Belgium Canada Denmark Finland France
1 800 144 130 0800 74 248 1 888 226 8633 80 88 07 45 0800 11 68 92 0800 905 397

Indonesia
Germany Holland Hong Kong Hungary Ireland
001 803 0441
0800 182 6937 0800 022 5072 0800 96 21 42 06 80013 318 1 800 551 716
1109

Israel Italy Japan Luxembourg Malaysia New Zealand


1 800 944 11 80 800 790 535 00531 78 22 21 0800 25 67 1 800 808 605 0800 445 938

Norway Portugal Singapore South Africa Sweden Switzerland


800 16 327 800 880 183 800 44 11 100 0800 992 872 0200 21 45 08 0800 83 75 77

Taiwan UK USA
0080 04 40 99 0800 068 06 88 1800 360 7909

For countries not listed above, Technical Support may be obtained via the following numbers:
UK: USA:
Phone: +44 1293-601-327 Phone: +1-434-979-1540
Fax: +44-1293-601-397 Fax: +1-434-979-1481
eFax: +1-866-385-1322
Technical Support E-mail: brachyhelp@varian.com
Notice Information in this user guide is subject to change without notice and does not represent a commitment on
the part of Varian Medical Systems, Inc. Varian Medical Systems 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 that is protected by copyright and is the sole property of
Varian Medical Systems. 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 Varian Medical Systems products are designed and manufactured in accordance with the requirements
specified within these federal regulations.
Quality System
Regulations (CGMPs)

ISO 13485:2003 Varian Medical Systems products are designed and manufactured in accordance with the requirements
specified within the ISO 13485:2003 quality standard.
CE 0086 Varian Medical Systems products meet the requirements of Council Directive MDD 93/42/EEC. European
representative:
Varian Medical Systems UK Ltd. +44-1293-601-200 Phone
Gatwick Road, Crawley +44-1293-891-386 Fax
West Sussex, RH10 9RG
United Kingdom
Legal Varian Medical Systems, Inc. +1-888-666-7847 Phone
3100 Hansen Way +1-434-979-1481 Fax
Manufacturer Palo Alto, CA 94304 USA

Manufacture Varian Medical Systems +49-2129-551-0 Phone


Haan GmbH +49-2129-551-55 Fax
Location Bergische Strasse 16
42781 Haan, Germany

Trademarks ARIA™, BrachyVision™, GammaMed™, GammaMedplus™, GammaMedplus™ iX, GammaMedplus™


3/24 iX, VariSource™, VariSource™ iX, and VariSource™ iX(t) are registered trademarks of Varian
Medical Systems, Inc. All other trademarks in this manual are the property of their respective owners. This
product includes software developed by the Apache Software Foundation.

© 2009 Varian Medical Systems, Inc.


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

ii
GM10 UG Book.book Page iii Tuesday, March 24, 2009 11:22 AM

CHAPTER SUMMARY

Introduction 1

Patient and Treatment Data 2

Delivery of Patient Treatment 3

System Configuration 4

Emergency Procedures 5

Functions Performed by Service Personnel 6

GammaMedplus 3/24 iX System 7

Appendix A - System Errors and Messages A

Appendix B - GammaMedplus iX Calculations B

Appendix C - Afterloader Technical Description C

Appendix D - Safety Information and Tests D

Appendix E - Transporting the GammaMedplus iX E

Appendix F - MammoSource iX Model F

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Unauthorized Software
The GammaMedplus iX system and its associated hardware and software
constitute medical devices. The software installed on the control PC by Varian
Medical Systems has been through rigorous testing in a controlled system
configuration. The use and/or addition of other software to this computer
violates the approved system configuration and risks potential system
malfunction. Although there are safeguards in the system to minimize the risk
of hazardous operation, the system may still shut down should it detect
corrupted data files or improper computer operation, preventing the completion
of patient treatment. The control PC must operate in “real time” to properly
administer a patient treatment. Any third party software or computer viruses
introduced by non-approved software may cause system instability and a
subsequent system shut down requiring a billable service call to restart.

In summary, do not load or run any unauthorized software on the


GammaMedplus iX system. Varian cannot be held responsible for the operation
of the system if this warning is ignored. Any service calls required as a result of
such misuse will be considered additional to Varian’s standard warranty or
service contracts.

Unauthorized Applicators
All Varian approved applicators have been tested against and passed strict safety
criteria. Under no circumstances should any applicator or catheter that has not
been approved by Varian be used in conjunction with the GammaMedplus iX
system. Varian cannot be responsible for the operation of the system if this
warning is ignored. Any service calls required as a result of such misuse will be
considered additional to Varian’s standard warranty or service contracts.

Unauthorized Sources
All Varian approved source wires have been tested against and passed strict
safety criteria. Under no circumstances should any source wire that has not been
approved by Varian be used in conjunction with the GammaMedplus iX system.
Varian cannot be responsible for the operation of the system if this warning is
ignored. Any service calls required as a result of such misuse will be considered
additional to Varian’s standard warranty or service contracts.

Wire Path Constraints


All safety testing of the GammaMedplus iX source wires has been performed
assuming a path constraint equal to the machine specification of a 1.3 cm radius.
Driving the wire into a path constraint with smaller dimensions than this
specification will have a detrimental effect on the life of the wire.

Extreme care should therefore be taken to ensure the wire path is not constrained
by less than 1.3 cm.

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The GammaMedplus iX equipment has been marked with the following


symbol:

This symbol indicates that the equipment so marked has been


designated as electrical and electronic equipment (EEE) that is not to be
disposed of at the end of its life as unsorted municipal waste. EEE
contains substances that may present hazards to human health and to
the environment. It must be recovered, reused, recycled, or otherwise
treated, and properly disposed of.

Please contact your Varian Customer Support representative to obtain


more information regarding return to ensure proper handling of this
equipment at the end of its life.

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GM10 UG Book.book Page vi Tuesday, March 24, 2009 11:22 AM

Symbols and Labels Used on the Equipment

Manufacturer location

Date of manufacture

Serial number
SN

Indicates Type B application

Protective earth (ground)

Primary protective earth

Radiation present in treatment room

vi
GM10 UG Book.book Page vii Tuesday, March 24, 2009 11:22 AM

Indicates proper disposal of waste


electronic and electrical equipment

Alarm condition

Caution, consult accompanying


documentation.

0 Battery voltage switched OFF

1 Battery voltage switched ON

Symbols Used in this Manual

Warning or Caution statement in text

Note in text

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viii
GM10 UG Book.book Page ix Tuesday, March 24, 2009 11:22 AM

Contents

CHAPTER 1 INTRODUCTION .....................................................................1-1


Glossary of Regulatory Terms.................................................................1-2
Audience ....................................................................................................1-3
Important Safety Information ...................................................................1-3
Operation ........................................................................................ 1-3
Safety Notices ................................................................................ 1-4
Precautionary Measures in Operation ......................................... 1-6
Potential Hazards ........................................................................... 1-6
Operating Environment ............................................................... 1-10
GammaMedplus iX System Components .............................................1-11
GammaMedplus iX Afterloader................................................... 1-12
Control Console ........................................................................... 1-18
Repeated Tone Functionality ...................................................... 1-23
Extended Sound Functionality ................................................... 1-23
Last Man Out Functionality ......................................................... 1-24
Control PC Hardware and Software ........................................... 1-25
Safety Interlocks .......................................................................... 1-25
Starting the GammaMedplus iX System ...............................................1-30
Overview of the Afterloader Control Software .....................................1-31
Start Page ..................................................................................... 1-32
Elements of a Page ...................................................................... 1-33
Major Workflows .......................................................................... 1-34
System Status Strip ..................................................................... 1-37
Network Connectivity .................................................................. 1-38

CHAPTER 2 PATIENT AND TREATMENT DATA........................................2-1


Open Patient File Workflow......................................................................2-2
Select or Import a Treatment File ................................................. 2-3
View and Modify Fractions.......................................................... 2-19
Create New Patient File Workflow .........................................................2-24
Enter Patient Data ........................................................................ 2-26
View and Define Fraction Data.................................................... 2-28

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View and Edit Channel Data...................................................................2-30


The Channel View Strip ............................................................... 2-31
The Channel Edit Strip................................................................. 2-33

CHAPTER 3 DELIVERY OF PATIENT TREATMENT .................................3-1


Typical HDR Treatment Sequence...........................................................3-2
Perform Treatment Day Tests and Checks.............................................3-3
Insert the Applicator .................................................................................3-4
Determine the Treatment Plan .................................................................3-5
Prepare the Patient, Afterloader, and Control Software........................3-6
Place the Patient in the Treatment Position ................................ 3-7
Adjust the Height of the GammaMedplus iX ............................... 3-8
Measure and Connect the Source Guide Tubes ......................... 3-8
Secure the Applicator .................................................................. 3-12
Instruct the Patient....................................................................... 3-12
Prepare the Control Software ..................................................... 3-12
Deliver and Monitor the Treatment........................................................3-13
Initiate a Treatment ...................................................................... 3-14
Review the Planned Treatment Report ...................................... 3-16
Begin the Treatment Delivery ..................................................... 3-17
Monitor the Treatment ................................................................. 3-20
Complete the Treatment Delivery ..........................................................3-29
Review Treatment Results .......................................................... 3-30
Look After the Patient.................................................................. 3-31
Secure the Afterloader................................................................. 3-32
Interrupt a Treatment ..............................................................................3-33
Partial Treatment Strip............................................................................3-34
Continue Treatment after Afterloader Power Failure................ 3-36
Continue Treatment after Control Software Failure.................. 3-36

CHAPTER 4 SYSTEM CONFIGURATION....................................................4-1


Access the System Configuration Page .................................................4-2
Define User Access and Location Information ......................................4-3
Define Users ................................................................................... 4-4

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Specify Access Privileges for Groups ......................................... 4-7


Specify Location Information...................................................... 4-10
Set Up File Folders....................................................................... 4-12
View and Edit Owner Information............................................... 4-15
Set Up the Console and Afterloader......................................................4-16
Check the System Status ............................................................ 4-17
Review Error and Event Logs ..................................................... 4-18
Annotate Error Messages............................................................ 4-22
Define a Standard Plan ................................................................ 4-23
Maintain the Applicator Definitions............................................ 4-27
Back Up and Restore Files.......................................................... 4-30
Change System Settings ............................................................. 4-33
Perform Physics and Service Functions ..............................................4-38
Create and Deliver Physics Test Plans ...................................... 4-39
Enter the Calibrated Source Strength ........................................ 4-44
View Source Exchange Data ....................................................... 4-48
Specify Service Parameters ........................................................ 4-51
Perform System Commands ....................................................... 4-52

CHAPTER 5 EMERGENCY PROCEDURES ................................................5-1


Emergency Contact Information..............................................................5-2
Definition of Emergency...........................................................................5-3
Precautions, Limitations, and Prerequisites ..........................................5-3
Precautions..................................................................................... 5-4
Limitations ...................................................................................... 5-4
Prerequisites .................................................................................. 5-5
Emergency Features and Functions .......................................................5-6
Alarm Indicators............................................................................. 5-6
Turn Off the Audible Alarm Signal ............................................... 5-7
Resolve the Cause of the Alarm ................................................... 5-8
Reset the Alarm.............................................................................. 5-9
Radiation Indicators..................................................................... 5-10
Automatic and Emergency Retraction of the Source ..........................5-11
Emergency Response Procedures........................................................5-14
Press the Interrupt Button or Emergency Return Switch ........ 5-14

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Press the Emergency Button ...................................................... 5-16


Perform Emergency Retraction with Emergency Handcrank .. 5-18
Perform Manual Recovery of the Source................................... 5-20
Remove the Applicator from the Patient.................................... 5-20
Pull the Source Wire from the Applicator .................................. 5-21
How to Continue an Interrupted Treatment ..........................................5-22

CHAPTER 6 FUNCTIONS PERFORMED BY SERVICE PERSONNEL.......6-1


System Installation ...................................................................................6-2
Annual Maintenance and Service Visits .................................................6-2
Source and Dummy Wire Exchange........................................................6-3
System Check After Disruption of Service .............................................6-4

CHAPTER 7 GAMMAMEDPLUS 3/24 IX SYSTEM ......................................7-1


System Description...................................................................................7-2
The Channel View Strip ............................................................................7-3
Insertion of the Applicator into the Patient ............................................7-4
Source Guide Tube Connection ..............................................................7-4
Transporting the 3/24................................................................................7-6

APPENDIX A SYSTEM ERRORS AND MESSAGES ................................. A-1


Afterloader Errors and Messages........................................................... A-2
Control Software Errors and Messages................................................. A-6

APPENDIX B GAMMAMEDPLUS IX CALCULATIONS .............................. B-1


Scaled Dwell Time.................................................................................... B-2
Source Decay ........................................................................................... B-3
Ir-192 Source Decay Table ........................................................... B-4
Transit Dose ............................................................................................. B-5
Transit Dose Algorithm ................................................................ B-5
Transit Absorbed Dose................................................................. B-8

APPENDIX C AFTERLOADER TECHNICAL DESCRIPTION ..................... C-1


Afterloader Description ........................................................................... C-2

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System Component Connections........................................................... C-4

APPENDIX D SAFETY INFORMATION AND TESTS.................................. D-1


Additional Safety Information ................................................................. D-2
IEC Requirements ......................................................................... D-2
Treatment Day Tests and Checks........................................................... D-4
Interruption of Treatment ............................................................. D-5
EMERGENCY RETURN Switch .................................................... D-6
Door Interlock................................................................................ D-7
Power and Power Failure ............................................................. D-8
Key Tests ....................................................................................... D-9
Room Radiation Monitor ............................................................ D-10
Afterloader Radiation Monitor ................................................... D-10
Source Guide Tube Misconnection ........................................... D-10
Viewing and Intercom Systems ................................................. D-10
Cleaning the Device ............................................................................... D-11
Emergency Response Procedures (for posting)................................. D-12
Press the Interrupt Button or Emergency Return Switch ....... D-12
Press the Emergency Button ..................................................... D-12
Perform Emergency Retraction with Emergency Handcrank . D-13
Perform Manual Recovery of the Source.................................. D-14
Remove the Applicator from the Patient................................... D-14
Pull the Source Wire from the Applicator ................................. D-15

APPENDIX E TRANSPORTING THE GammaMedplus IX.......................... E-1


Preparing the GammaMedplus iX for Transport ................................... E-2
Inserting the Source Locking Wire......................................................... E-3
Moving the GammaMedplus iX ............................................................... E-5

APPENDIX F MAMMOSOURCE™ IX MODEL ............................................ F-1


System Description.................................................................................. F-2
The Channel View Strip ........................................................................... F-2
Insertion of the Applicator into the Patient ........................................... F-3

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xiv GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Chapter 1 Introduction

The GammaMedplus iX™ system is a remote-controlled afterloading device for 1


high dose rate brachytherapy. It utilizes a small, high activity Iridium-192 source
that is fixed to a stainless steel cable and moved into an applicator or catheter
inserted into the patient. The source may be sequentially extended into a
maximum of 24 catheters and positioned at up to 60 discrete points (dwell
positions) for individual dwell times of 0.1 to 9999.9 seconds. In this way, the
system is able to control the dose distribution over the required treatment volume
and minimize dose to healthy tissue.
This User Guide describes the processes involved in preparing, delivering, and
monitoring brachytherapy treatments using the GammaMedplus iX system.

WARNING 1-1: The afterloader control software enables you to import, edit, and
deliver a predetermined treatment prescription. The software
does NOT perform any dosimetric calculations related to the
determination of the proper treatment plan except for computing
source decay. The actual treatment plan is usually created using
a brachytherapy treatment planning system, which, with the
exception of its file interface to the control software, is beyond
the scope of this document. Be sure to check the integrity and
clinical accuracy of any data that you import or enter before
delivering a treatment. Failure to do so may result in incorrect
treatment and may cause serious injury to the patient.

In This Chapter

Topic Page
Glossary of Regulatory Terms 1-2
Audience 1-3
Important Safety Information 1-3
GammaMedplus iX System Components 1-11
Starting the GammaMedplus iX System 1-30
Overview of the Afterloader Control Software 1-31

1-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Glossary of Regulatory Terms


This section defines regulatory terms and concepts as used in the context of this
guide. It is the responsibility of the end user to satisfy regulatory requirements.

• Agreement State (US only)


Federal law permits a state to reach an agreement with the United States
Nuclear Regulatory Commission (USNRC) allowing that state to regulate
the use of the USNRC-licensed radioactive materials within its borders.
That state is then called an Agreement State.
• Authorized user
A person who is listed on a document (either a license issued by a
Competent Authority or other document in full accordance with a
license) as a user of high dose rate (HDR) equipment.
• Competent Authority
Any governing or regulating body that establishes and implements
regulations, issues licenses to possess and use radioactive material, or
otherwise establishes policy and rule making. In the United States, the
Competent Authority is either the USNRC or the equivalent body in an
Agreement State. As examples, in Canada, the Competent Authority is the
Canadian Nuclear Safety Commission; in Germany, the Bezirksregierung
(District Agencies); in Mexico, the Comisión Nacional de Seguridad
Nuclear y Salvaguardias; and in the United Kingdom, the Environment
Agency.
• Normal form radioactive material
Radioactive material that has not been demonstrated to qualify as special
form radioactive material.
• Qualified user
A person who is authorized and has maintained competency in the use of
HDR equipment.
• Special form radioactive material
Radioactive material that satisfies the requirements for special form as
stated in IAEA Safety Standards Series No. TS-R-1 “Regulations for the
Safe Transport of Radioactive Material” 1996 (Amended 2003).

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Audience
The GammaMedplus iX User Guide is intended for radiation oncologists,
radiation therapists, and medical physicists who use the GammaMedplus iX 1
system to deliver patient treatments at a site or clinic.

The GammaMedplus iX system is intended for use by an expert user. The


system can be dangerous if improperly used. By law, the United States Nuclear
Regulatory Commission (USNRC), Agreement States, and the Competent
Authority in other countries allow only authorized and qualified users to
possess and use brachytherapy sources. Additionally, quality assurance and
safety procedures related to all HDR operations and radiation safety must be
approved and implemented. All GammaMedplus iX users shall be fully trained
in brachytherapy procedures and the GammaMedplus iX system, including the
afterloader control software. All users must read this manual and understand
the function of each control as well as the direct action caused by its use.

Note: Please read the “Glossary of Regulatory Terms” section above


to ensure you understand the meaning of Competent Authority
as used in this document.

Important Safety Information


The GammaMedplus iX system is carefully designed to minimize potential
hazards; however, all users are advised to read the following safety
information carefully. For additional safety information, including safety tests
and checks, refer to Appendix D “Safety Information and Tests”.

Operation
The GammaMedplus iX should be operated only by those persons who have
training in HDR radiation safety and who have been instructed in the use of this
device.

Introduction 1-3
GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

Adequately shielded facilities shall be in place to facilitate operation and


storage of the GammaMedplus iX. The treatment room and door shall be
shielded sufficiently to meet USNRC, Agreement State, and other Competent
Authority regulations.

Safety Notices
The GammaMedplus iX system is a licensed medical device used for
delivering ionizing radiation to a patient. In order to prevent unintended
exposure to radiation, the safety notices and directives listed below shall be
followed:

• The device shall be operated in accordance with the user’s radioactive


materials license obtained from the USNRC, Agreement State, or other
Competent Authority.
• For the duration of an HDR treatment, the device shall be supervised by an
authorized and qualified user who has been trained in the safe operation of
the device.
• The device shall be used only in a treatment room with restricted access.
• The user shall secure the device against unauthorized operation by
removing the SOURCE RELEASED/LOCKED key and maintaining
secure control of the key.
• Device maintenance shall only be performed by Varian Medical Systems
service engineers or by those persons authorized by Varian and having a
radioactive materials license to do so.
• Opening the device housing is permitted only by Varian Medical Systems
service engineers or by those persons authorized by Varian and having a
radioactive materials license to do so.
• The source exchange shall only be performed by Varian Medical Systems
service engineers or by those persons authorized by Varian and having a
radioactive materials license to do so.
• Only components and accessories authorized by Varian Medical Systems
shall be used with the device. This refers to the source, applicators, source
guide tubes or catheters, service tools, and any and all other accessories.
Use of unapproved components and accessories may put the device in an
unsafe or otherwise dangerous configuration.

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GM10 UG Book.book Page 5 Tuesday, March 24, 2009 11:22 AM

• The emergency container shall be located near the device in the treatment
room along with the wire cutter and pair of long handled forceps.
• The GammaMedplus iX is certified as a Type A container and may be
transported with an active source installed. In such case (even when 1
moving the device between two treatment rooms), the source shall be
secured in the device by inserting the source locking wire into
Channel 1 and switching the battery supply off by turning the battery key
switch to position 0 (OFF). Refer to Appendix E “Transporting the
GammaMedplus iX” for more information.

WARNING 1-2: Observe all applicable regulations regarding the


transportation of radioactive material. Regulations are
designed to ensure that radioactive material is transported
safely and to reduce the potential of an accident. Failure to
adhere to the applicable regulations increases the likelihood of
a transportation incident or regulatory citations in the event of
a vehicle inspection.

• Operation and storage of the afterloader shall be permitted only in rooms


that have been approved by the facility’s management, including the
Radiation Safety Officer.
• The electrical safety equipment has a backup battery supply. If the
GammaMedplus iX has been unplugged for any period of time, the
condition of the battery shall be checked prior to use of the device.
• A safety check of the GammaMedplus iX system shall be performed daily
before use in accordance with your radioactive materials license.
• The device shall be used only in an environmentally controlled room and
shall be protected against penetration by water or other liquids.
• The device shall not be operated in the presence of flammable gases, since
it is not protected against ignition of combustible gas.
• The applicators shall be clean and dry (in case of steam sterilization) prior
to connection of the device.

Introduction 1-5
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Precautionary Measures in Operation


• An independent radiation monitoring system with visual and audible
output is required in the treatment room. A battery backup capable of
maintaining the system in an operable condition shall be available in case
of interruption of the AC power supply.
• Viewing and intercom systems shall be installed in the treatment room.
This equipment shall be used for the duration of the HDR treatment.
• The GammaMedplus iX device shall not be moved while a patient is
connected to the device.
• Objects shall not be placed on the GammaMedplus iX device.
• Connection and data cables shall not be coiled around the
GammaMedplus iX device or its handles.
• Attention shall be paid to placement of the connection and data cables to
prevent tripping hazards.
• When the GammaMedplus iX device is not actively being moved, the foot
brake shall be locked at all times to prevent unintentional movement.
• The surface of the GammaMedplus iX device shall be cleaned regularly
using only a damp cloth. The surface of the plastic membranes covering
the afterloader keypad and remote consoles shall be cleaned with a suitable
disinfectant.

Potential Hazards

Electrical Shock

The GammaMedplus iX afterloader meets the electrical safety requirements of


international standards, such as the International Electrotechnical Commission
(IEC). The hazard of electric shock is similar to that of any other electrical
laboratory or medical equipment. The same is valid for the control PC and
monitor, which are used for treatment preparation and control. The afterloader
is powered by a 100 V, 115 V or 230 V power line. In emergency cases, a
24-volt DC battery can power the drive and control system of the device. An
internal battery charger connected to the main power line recharges the battery.

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WARNING 1-3: Dismantling the device should only be attempted by Varian


authorized service personnel. Failure to heed this warning may
result in injury.

Personal Injury

The GammaMedplus iX is a movable device with a weight of approximately


130 kg (287 lb.) Due to the heavy radiation shielding, the center of mass is
located in the upper section of the device. Therefore, the device should be
transported with the source head lowered in order to provide greater stability.
Care should be taken when moving the device on inclined floors to prevent
tilting. When the device is in its final position, it shall be secured with the foot
brake to prevent unintentional movement.

The cables connecting the GammaMedplus iX and the control electronics


should be laid on the floor to allow proper positioning of the device beside the
patient. Do not step on the cables. When moving the device, wind up all cables
on the provided retainers.

Radiation Concerns

The HDR sources are highly radioactive. As such, radiation safety is a high
priority when working with and around the GammaMedplus iX device. The
device is subject to USNRC, Agreement State, and other Competent Authority
regulations for the handling of radioactive material. Personnel shall follow all
safety instructions exactly for safety and regulatory reasons.

• Source and Machine


The Iridium-192 source and the GammaMedplus iX device are listed in the
Registry of Radioactive Sealed Sources and Devices maintained by the
USNRC.

The Iridium-192 source is in metallic form, encapsulated in stainless steel,


and has satisfied the conditions of special form radioactive material.
Therefore, it has high intrinsic safety properties against leakage, heat, and
mechanical stress.

Introduction 1-7
GM10 UG Book.book Page 8 Tuesday, March 24, 2009 11:22 AM

• Source Exchange
Only service personnel authorized by Varian Medical Systems shall
perform the source exchange. The sources will be delivered to the clinic in
approved shipping containers.
• Source Strength
The maximum source strength that can be installed or used is defined in
your site specific license.
• Source Extension
GammaMedplus iX users shall only extend the active wire during patient
treatments and during safety and quality checks of the system.
• Transportation
When shipping the sources in the approved container, the appropriate
national or international regulations for the safe transport of radioactive
material shall be followed. The device and, if applicable, its packaging
shall be labeled according to these regulations.
• Emergency Situations
Personnel shall be familiar with, and trained in, all HDR safety procedures.
Personnel shall plan for and practice the emergency response procedures
developed at your site to assure an immediate and quick response in case
of an emergency. Refer to Chapter 5 “Emergency Procedures” for more
information.
• Safety Interlocks
The proper functioning of all GammaMedplus iX safety interlocks and
interlock checks shall be verified before patient preparation and patient
treatment begin.

WARNING 1-4: Any attempt to disable the safety interlock system could result
in injury. Modification of this safety system is prohibited by
regulations.

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Radioactive Contamination

The Ir-192 source assembly is designed and built as special form radioactive
material. As such, it should never leak radioactive material. However, should
there be any suspicion that the source is damaged or leaking radioactive 1
material, the Radiation Safety Officer (RSO) at your site and a Varian service
representative must be informed immediately and contamination checks shall
be performed.

Fire

If a fire occurs during patient treatment, retract the source into the shielded
position immediately. Once the radiological and physical safety of the patient
has been established, proceed with normal fire fighting procedures.

Due to the properties of the source, no restrictions are necessary for


extinguishing a fire when the source is retracted into its shielded position.
Check with your local fire authorities and ensure that the proper fire
extinguishers are available in the immediate vicinity of the GammaMedplus iX
device.
In case of fire, the RSO should monitor the radiation in the areas around the
device and notify authorities as required by license conditions or other
agreements. Varian Medical Systems should also be notified as soon as
practicable.

Explosion

There is a very remote chance of minor sparking in relays or motors during


normal operation of these devices. As with all relays or motors, these minor
sparks may be sufficient to ignite a combustible atmosphere or objects in an
oxygen-enhanced environment.

WARNING 1-5: Do not use the device in the presence of anesthetics or other
flammable gases, or in an oxygen-enhanced atmosphere, as
there is a risk of explosion.

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WARNING 1-6: Under rare circumstances, such as a defect in the circuit that
charges the battery, the battery may produce explosive gas.
For this reason, keep the device away from sparks and flames.
Adequate ventilation must be provided.

Operating Environment
The GammaMedplus iX is designed to be operated and stored in an
environmentally controlled area such as a hospital or laboratory. The
GammaMedplus iX should not be exposed to extreme moisture, high or low
temperatures, or to abnormal amounts of dust and debris. The recommended
environmental conditions are as follows:

Temperature Range: 15°C to 35°C (59°F to 95°F)

Relative Humidity: Not to exceed 75%, non-condensing

Air Quality: Typical levels for a hospital or laboratory


environment.

Atmosphere: Typical levels for a hospital or laboratory


environment. Do not use the device in the
presence of anaesthetics or other flammable
gases, or in an enhanced oxygen atmosphere,
as there is a risk of explosion.

Shock and Vibration: Typical levels for a hospital or laboratory


environment. The device can withstand the
shock and vibration levels associated with
movement by vehicle.

The GammaMedplus iX may not function properly if exposed for an extended


period of time to alternating environmental conditions. The
GammaMedplus iX should be stored in the recommended environment to
ensure safe operation and equipment longevity.

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During transport, the GammaMedplus iX may be subjected to conditions


outside the recommended environmental conditions. Should this occur, prior
to use, the GammaMedplus iX should be allowed sufficient time to adjust to
recommended environmental conditions.
1

GammaMedplus iX System Components


The GammaMedplus iX system consists of the following components/
functionality:

• GammaMedplus iX afterloader with afterloader keypad


• Control Console
• Repeated tone functionality
• Extended sound functionality (optional)
• Last Man Out functionality
• Control PC hardware and software
• Safety interlocks
• Emergency container

Each of these components is described below.

WARNING 1-7: Misuse or malfunction of the HDR treatment system can


expose the operator and/or the patient to electrical shock
and/or radiation. Either of these hazards could cause serious
injury or even death. If any of the controls do not function as
described in this user guide, do not use the equipment until it
has been checked for proper operation by a Varian authorized
service engineer.

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GammaMedplus iX Afterloader
The GammaMedplus iX afterloader is equipped with an Iridium-192 (Ir-192)
source. The source can be moved into 24 channels in succession via the
indexer head. In each of these channels, the source may be programmed to stop
in up to 60 dwell positions. The applicator in the patient is connected to the
afterloader via one or more source guide tubes.

In addition to the Ir-192 source, the GammaMedplus iX is equipped with a


second, inactive wire. This dummy wire serves to check the free passage and
overall length of the source guide tube/applicator assembly of 130 cm.

The wires used for the dummy and active source are moved by electrical
motors coupled to drive wheels that are in contact with the wire. This drive
system allows for precise wire movement with a minimum of components. All
normal wire movements, both in and out, are performed by the motors. The
emergency retract system is only used upon failure of the main drive system.

Indexer head

Device housing (with


adjustable height)

Chassis

Trailing wheels

Swivel wheels

The GammaMedplus iX operates on AC mains power. In case of a mains


failure, the built-in storage battery automatically supplies power to the safety
circuits of the GammaMedplus iX. The battery is charged constantly during
the normal mains supplied operation of the device.

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The device housing is adjustable in height, enabling you to place it in the


optimal position for patient treatment. The device housing contains the source
in a shielded container, the dummy wire, the motor drives for the source and
dummy wires, the indexer head, the afterloader keypad, the height adjustment
control (inside the keypad), and the electrical control unit. The chassis contains 1
the battery and the power supply units. An optional source guide tube support
can be screwed into the mid-upper opening of the indexer head.

WARNING 1-8: The GammaMedplus iX housing should only be opened for


service by Varian Medical Systems service engineers or by
those persons authorized by Varian Medical Systems and
having a radioactive materials license to do so. Do not open
the device, as this may cause a malfunction and endanger
safety.

The GammaMedplus iX rests on four wheels that you can lock in place by
means of the central foot brake lever. When the foot brake is released, you can
easily move the device with the help of the large lateral handles.

Afterloader keypad

Handcrank

Foot brake

Key switch for


battery supply

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CAUTION: When moving the device, pay attention to the connection


cables. Do not run over the cables. Place the cables in the room
carefully to avoid risk of tripping. Any remaining cable should
be placed in large coils near the GammaMedplus iX. Never
wind cables around the handles of the device.

The handcrank is positioned on the back of the GammaMedplus iX. In the


unlikely event of a malfunction of the automatic motor driven source
retraction, the source can be manually retracted using the handcrank.

The battery key switch is located at the bottom of the afterloader near the foot
brake. Usually the key switch must be in the I (ON) position. If you are
transporting the device, you must switch the key to the 0 (OFF) position. Refer
to Appendix E “Transporting the GammaMedplus iX” for more information.

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Afterloader Keypad

The afterloader keypad is located on the back of the GammaMedplus iX. The
keypad consists of the following areas:
1
• SOURCE section and key switch
• DUMMY section
• HEAD section
• RADIATION section
• EMERGENCY button
DUMMY section HEAD section
DUMMY wire control Height adjustment of device housing
OUT = extension UP = raise
IN = retraction DOWN = lower

SOURCE section
RELEASED
Source ready
RADIATION section
for extension
RADIATION light
Indicates presence
LOCKED
of radiation
Source locked
Key switch used
to release or
lock source
EMERGENCY button
POWER Provides rapid
AC power retraction of source
supply okay in case of
emergency
CHARGE
Storage battery is
being charged

SOURCE Section and Key Switch

The SOURCE section contains the key switch used to lock the Ir-192 source
or to release it for extension during treatment and testing. The LOCKED
indicator light flashes when the key is in the vertical position. The
RELEASED indicator light turns on when the key is in the horizontal position.

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Note: For safety reasons, the key switch should remain in the
LOCKED position with the key removed and in a secure
location unless you are performing a treatment or test.

The POWER light indicates that the afterloader is connected to AC power, and
the CHARGE light indicates that the storage battery is being charged.

Note: You should not normally disconnect the power to the system
unless there is a specific need to do so. If the device has been
unplugged for a long time, the storage battery may require
recharging before use.

DUMMY Section

In conjunction with the Channel Editor in the control software, you can use the
DUMMY section of the keypad to change the distal position of the source.
Refer to the “Change the Distal Position of the Source” section in Chapter 2
“Patient and Treatment Data” for more information.

HEAD Section

The HEAD section contains the UP and DOWN buttons that control the
motorized height adjustment of the afterloader. The adjustment range is
between 90 and 130 cm (35 and 51 inches) from the floor to the center of the
indexer head.

CAUTION: When transporting the device, lower the source head fully in
order to provide maximum stability.

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RADIATION Section

The RADIATION indicator light turns on when the GammaMedplus iX


detects radiation outside the shielded safe. This shows that the source is no
longer in the shielded position and that there is the potential of radiation 1
hazard. The built-in Geiger-Müller detector of the GammaMedplus iX detects
radiation in the treatment room as long as the afterloader is turned on. In
particular, this device detects radiation as soon as the source leaves its shielded
position and continues to monitor the radiation level until the source is
retracted safely into its shielded position.

Note: An independent radiation monitoring system with visual and


audible output is required in the treatment room.

EMERGENCY Button

In emergency situations, you can retract the source immediately by pressing


the EMERGENCY button. Refer to Chapter 5 “Emergency Procedures” for
detailed information on emergency response procedures.

WARNING 1-9: The EMERGENCY button bypasses the control PC software


and interfaces directly with the source motor drive to retract
the source with maximum speed. As soon as the source is in
its shielded position, the RADIATION light is extinguished.
You must survey the room with a portable radiation meter
to assure the source is back in its shielded position. Failure
to perform this survey may result in serious injury to you or
the patient.

Service Opening for Dummy Wire

The access for the dummy wire is located on the right side below the
afterloader keypad. The dummy wire can only be replaced by Varian
authorized service personnel.

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Service opening
for dummy wire

Control Console
The Control Console is the main control panel for the GammaMedplus iX
afterloader. This device should be located next to the control PC. You use the
Control Console to enable power to the other GammaMedplus iX devices, to
activate special functions mode, and to monitor the status of the source,
treatment, and alarm circuits. A red light on the Control Console may indicate
an alarm situation requiring immediate intervention, yellow indicates the
presence of radiation, and green indicates correct functioning.

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The Control Console consists of the following areas:

• POWER section and key switch


• MODE section and key switch
1
• SOURCE section
• TREATMENT section
• ALARM section

The POWER, MODE, and SOURCE sections on the left side of the Control
Console are labeled in the graphic below and then described.

RADIATION symbol INDICATOR LIGHTS


Indicates presence OUT
of radiation Source unshielded, radiation
present
SAFE
Source in shielded position
LOCKED
Source locked in shielded position

NORMAL
All treatment functions able to
MODE Key Switch operate
SPECIAL
Service mode with special functions

MAINS
POWER Key Switch Main AC power supply okay
BATTERY
Function of charged battery okay

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POWER Section and Key Switch


The main key switch is located in the POWER section. When you switch the
system on by turning the key to the horizontal position, the MAINS and
BATTERY indicators should light up. The proper functioning of the main AC
power supply is indicated by the MAINS light. The BATTERY light indicates
the proper functioning of the charged battery, which powers the safe retraction
of the source in case of AC power failure.

When the POWER key is switched on, an automatic test of the Control
Console indicators is performed. Refer to the “Starting the GammaMedplus iX
System” section below for more information.

MODE Section and Key Switch

The MODE section contains a second, unique key switch that is used by
Varian authorized service personnel for test and service purposes and to
activate special functions, such as changing the distal offset of the source via
the IN and OUT buttons on the DUMMY section of the afterloader keypad.
With the key in the horizontal position, the SPECIAL indicator light turns on.
For all other functions of the GammaMedplus iX system, the key switch must
be in the vertical position, with the NORMAL indicator lit.

WARNING 1-10: For safety reasons, insert the MODE key only when
necessary and guard it against unauthorized use.

SOURCE Section

The SOURCE section indicates the status of the source and serves as a safety
indicator. The yellow RADIATION indicator turns on if radiation is detected
in the treatment room. The yellow OUT indicator light flashes as the active
source is being extended and illuminates permanently when the source has
reached a dwell position. When the source moves again, the OUT indicator
flashes until it reaches another dwell position or returns to the shielded
position. The SAFE indicator light turns on when the source is retracted fully
into its shielded position. The LOCKED indicator light flashes when the
source is locked at the key switch on the afterloader keypad.

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WARNING 1-11: If one of the two yellow indicators does not light up during a
treatment, there is a possibility of a system malfunction, and
an error message is displayed on the control PC. The
treatment must be interrupted immediately. Check for the
cause of the error and correct the problem. Failure to do so 1
may result in injury to the patient.

The TREATMENT and ALARM sections on the right side of the Control
Console are labeled in the graphic below and then described.

INDICATOR LIGHTS
STARTED
Flashing light: before pressing the
START button START button
Starts treatment
Steady light: treatment in progress
COMPLETED
INTERRUPT button Treatment completed
Interrupts treatment INTERRUPTED
Treatment interrupted
ALARM signal
Flashing alarm indicates
malfunction and possible DOOR
radiation hazard Steady light if door of the treatment
room is opened during treatment
ALARM RESET button DOSE
Resets the audible alarm signal Steady light if the external dose
measurement unit has exceeded a
BUZZER OFF button warning threshold
Turns off audible warning signal BUZZER OFF
Indicates audible warning signal
turned off

TREATMENT Section

The TREATMENT section controls the start of treatment, the interruption of


treatment, and displays information about the treatment status. After you
choose to deliver a treatment in the control software, the STARTED indicator
light flashes and a steady beeping signal on the Control Console is audible.

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By pressing the START button, the audible signal ceases and the STARTED
indicator changes to a steady light, showing that treatment is in progress. At the
end of the treatment, the COMPLETED indicator light turns on and an
intermittent signal is audible. You can turn off the audible signal by pressing
the BUZZER OFF button.

You can interrupt the treatment by pressing the INTERRUPT button, which
causes the source to be retracted at normal speed. The INTERRUPTED
indicator light flashes and an audible signal can be heard.
After other interruptions (e.g. when the door of the treatment room has been
opened) the INTERRUPTED indicator light flashes, accompanied by the
audible signal (and, in this case, the DOOR light).
You can usually continue an interrupted treatment by pressing the START
button on the Control Console. Refer to Chapter 5, “Emergency Procedures”
for detailed information on interrupting a treatment during an emergency.

Note: Pressing the INTERRUPT button causes the source to retract


at normal speed, whereas pressing the EMERGENCY button
causes the source to retract at maximum speed.

ALARM Section

Urgent alarms are indicated in the ALARM section. If an error in the treatment
sequence occurs or if there is a malfunction of the GammaMedplus iX (e.g. if
the source is not automatically retracted), the red alarm symbol flashes and a
simultaneous audible alarm signal sounds.
You can turn off the audible signal by pressing the BUZZER OFF button. In
this case, the BUZZER OFF indicator light turns on. If the error condition
remains uncleared, the audible signal will sound again in 5 minutes.
After clearing the cause of the alarm, you can reset the visible and audible
alarm signals by pressing the ALARM RESET button. If no alarm reset is
executed, but the cause of the alarm is cleared, the alarm will be reset when you
press the START button.

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Note: If the cause of the alarm is not cleared, the alarm signal is
repeated after pressing the START button.

The red DOSE indicator light turns on if an external dose measurement unit
has exceeded a set warning threshold. The GammaMedplus iX retracts the 1
source immediately into the shielded position. Before continuing the treatment,
the external device must be reset to start up with initial values and to set the
dose input of the GammaMedplus iX to a ready state.

The red DOOR indicator light turns on if the door of the treatment room is
opened at any time. If the door is opened during a treatment, the treatment is
interrupted automatically and the source returns to its shielded position. Verify
that no persons other than the patient are in the room. After closing the door,
the treatment can be continued by pressing the START button.

Repeated Tone Functionality


If a system request, interruption, or alarm occurs, the afterloader flashes the
appropriate indicator lights and sounds an audible tone. The tone can be
switched off by pressing the BUZZER OFF button. In order to remind you to
resolve the cause of the request, interruption, or alarm, the tone will repeat 5
minutes after turning the buzzer off. If there are any further reasons for the
audible tone to sound, the buzzer will be switched on again.
The buzzer repeat functionality can be used unlimited times.

Extended Sound Functionality


This feature is a non-standard item that is not routinely supplied with the
system.

The extended sound functionality provides audible support for determining the
status of a treatment. The sound system uses three distinct tones for identifying
the different states of the afterloader:

• Standard tone — a flat, steady tone can be heard at each movement of the
source drive and when each user input is required
• Attention tone — a rising tone can be heard if any normal interruption in
treatment occurs and when a treatment is completed normally

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• Error tone — an alternating low-high tone can be heard if any error occurs
during treatment

The tones are produced by a loudspeaker included in a special version of the


Control Console. The console is positioned in the same location as the console
for the standard GammaMedplus iX environment — beside the control PC.

Last Man Out Functionality


The Last Man Out feature is supplied standard with the system. However, you
may choose not to have this feature installed. Observe all applicable local
regulations with regard to the Last Man Out functionality.

The Last Man Out system acts as an additional safety feature for supervision
of the door of the treatment room. This system is active as long as the power to
the afterloader is switched on. The Last Man Out button is located inside the
treatment room, next to the door. In order for a treatment to commence, this
button must be pressed prior to closure of the treatment room door.

After preparing the patient for treatment, you need to verify that no one except
the patient is in the treatment room. You then press the Last Man Out button
before exiting the treatment room. The green indicator light inside the Last
Man Out button begins to flash. Once the Last Man Out button is pressed,
you have a predefined period of time to leave the treatment room and close the
door. This time period is set by service personnel.

If you correctly follow the Last Man Out sequence within the given time
period, treatment may begin. The flashing green indicator light on the Last
Man Out button turns to solid green. The DOOR indicator light on the Control
Console is switched off.

After pressing the Last Man Out button, if you do not close the door or do not
close the door within the given time period, the room is not accepted as
certified for treatment. The flashing green light on the Last Man Out button
turns off, and treatment may not begin. The DOOR indicator light on the
Control Console remains illuminated.

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Control PC Hardware and Software


The GammaMedplus iX control PC controls and monitors data input and
treatment delivery. During a treatment, the control PC communicates with the
afterloader and sends instructions to deliver the prescriptions specified in the 1
treatment plan. The control PC monitors treatment progress and reports any
errors that are detected. Various printouts relating to patient and system
information are generated, either automatically or upon request.

The control PC consists of a central processor unit, disk drive, CD/DVD-RW


drive, keyboard, monitor, and printer. The afterloader control software
installed on the PC automatically starts when you turn on the PC. Refer to the
“Starting the GammaMedplus iX System” and “Overview of the Afterloader
Control Software” sections below for more information on starting the system
and using the control software. Refer to the “System Component Connections”
section of Appendix C “Afterloader Technical Description” for more
information on the PC hardware.

The printer is connected to the control PC via a standard USB interface. The
printer helps you document the steps taken during treatment and also produces
reports on any malfunction of the system. You can print data disclosure
reports, treatment history, error reports, diagnostic reports, and other reports
related to system usage. The printer should be switched on for normal
operation and should contain an adequate supply of paper. Refer to the user
manual supplied with the printer for details on usage.

Safety Interlocks
The GammaMedplus iX system contains a series of safety interlocks and
interlock checks that must be satisfied before you can begin treatment. Some
of these interlocks are represented by icons in the Treatment Delivery Strip on
the Treatment Delivery Page. The icons for satisfied interlocks display in green
and for unsatisfied interlocks display in red.

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The following is a list of the safety interlocks:

• MODE key interlock


This interlock prevents treatment initiation unless the MODE key switch
on the Control Console is in the NORMAL position. Once the treatment
has begun, you can change the key switch to the SPECIAL position if
necessary.

• SOURCE key interlock


This interlock prevents treatment initiation unless the SOURCE key
switch on the afterloader keypad is in the RELEASED position.

• Door interlock
This interlock interrupts the treatment in progress and retracts the source
into the shielded position if the treatment room door is opened while a
treatment is in progress. After the treatment room is cleared of personnel
and the door is closed, the treatment can be resumed by pressing the
START button on the Control Console. This interlock also prevents
initiation of a treatment if the door is already open.
• Emergency return switch
This interlock detects the status of the EMERGENCY RETURN
switches (at least one is located in the control room with a second one in
the treatment room) and disables or interrupts treatment if this switch has
been pushed and remains pressed down. Refer to the “Automatic and
Emergency Retraction of the Source” section of Chapter 5 “Emergency
Procedures” for more information.

Note: If you hover the mouse pointer over an individual icon, the
name and status (Passed/Failed) of the interlock displays to the
left of the icons in the Treatment Delivery Strip.

Note: If your system configuration includes a Dose or


Enable/Disable interlock, the control software checks to verify
the proper status of the interlock before treatment begins.

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The following conditions must also be satisfied before treatment can begin:

• Mains power supply must be present.


• Battery must be fully charged with the battery key switch in the ON
position. 1
• POWER key switch must be in the ON position.
• MODE key switch must be in the NORMAL position.
• SOURCE key switch must be in the RELEASED position.
• Sufficient wire cycles for treatment completion must remain.
• Afterloader must not be in a manual interrupt or error state.
• All emergency switches must be released.

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Viewing and Intercom Systems

Viewing and intercom systems are required for observation of the patient
during treatment. If you are using a video camera, you need to adjust the
camera in such a way that the patient can be observed. An intercom is also
required for two-way verbal communication with the patient at all times.

Note: Viewing and intercom systems are not part of the supply by
Varian unless specifically ordered. See the manufacturer’s
instructions for these devices.

Video observation camera Control room

Treatment room

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Emergency Container

Since the GammaMedplus iX utilizes a radioactive source, safety measures for


emergency situations are required. The emergency container must be located
in the treatment room and must be accessible during each treatment. In case of 1
an emergency, if the source cannot be retracted into the shielded position in the
GammaMedplus iX, the radioactive source can be stored safely in the
emergency container.

The container is made of steel with a lead lining and a sealing lead lid. Cutters
attached to the container allow for cutting off the source from the extension
wire. A pair of long handled forceps can be used for picking up the source. The
forceps allow you to hold the source at a greater distance from the body, thus
reducing exposure to radiation.

WARNING 1-12: The manual recovery of a source represents an exceptional


situation and exposes the operator to a relatively high dose
of radiation. Persons who are pregnant or under the age of 18
are not allowed to perform this procedure.
Practice and follow emergency response procedures.

Refer to Chapter 5 “Emergency Procedures” for detailed information on


emergency retraction procedures.

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Starting the GammaMedplus iX System


When the afterloader is not in use, the power cord should remain plugged in at
all times with the POWER and CHARGE indicators lit on the afterloader
keypad. The SOURCE key switch on the afterloader keypad should be in the
vertical position with the key removed. The POWER and MODE key
switches on the Control Console should also be in the vertical position with the
keys removed. All keys should be stored in a secure area.

To start the GammaMedplus iX system, insert the security key in the key
switch of the POWER section on the Control Console and turn it to the
horizontal position. The GammaMedplus iX automatically performs an
indicator test in which all indicator lights on the Control Console (and any
other external consoles) flash briefly, and at the same time an audible signal is
generated. When the indicator test is complete, several indicator lights remain
lit on the Control Console — the MAINS and BATTERY indicators in the
POWER section, the NORMAL indicator in the MODE section, and the
SAFE indicator in the SOURCE section. In addition, the LOCKED indicator
in the SOURCE section of the Control Console and afterloader keypad
flashes.

Note: During the automatic indicator test, the yellow RADIATION


indicator illuminates briefly.

When you power up the control PC, the afterloader control software
automatically starts up on the PC. During the startup sequence, the control
software performs a series of self-tests. If any of the self-tests fail, the control
software displays detailed information describing the problem, probable
causes, and suggested actions to take.

Examples of self-tests are:

• Tests whether the afterloader is accessible over the communications line


and is responding.
• Checks for a supported version of the afterloader firmware; if not found,
halts the start up and notifies the user.
• Verifies that the afterloader and control PC clocks are synchronized to
within 15 minutes of each other.

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Note: For a given GammaMedplus iX system configuration, each


time the control PC is powered up, it queries the afterloader for
relevant information, such as machine serial number, source
wire serial number, and active and dummy wire cycles. If the
control PC is subsequently connected to a different afterloader, 1
this change will be detected at connection, and the queried data
will be updated in the System Configuration tabs. You will be
prompted to recalibrate the source strength and re-enter the
calibration data in the Source Strength tab.

Overview of the Afterloader Control Software


The control software provides a safe and user-friendly interface to all
GammaMedplus iX functions, including entering patient data, importing and
editing a treatment plan, and delivering a predetermined treatment
prescription. The user interface is divided into a series of full-screen pages,
with each page devoted to a small set of steps necessary to administer a
treatment. All required data on any given page must be present and validated
before you are permitted to proceed to the next page. Organizing the interface
in this manner enables you to step through the treatment process in an orderly
fashion. Basic system status information is visible at all times at the bottom of
the screen.

The administrator for the afterloader control software specifies which users
have access to the system. Each user has a login account that belongs to a user
group. Members of a group can perform certain functions based on the access
privileges associated with the group. The user interface allows for flexibility in
assignment of user privileges, including the privileges of the administrator
group.

Parts of the control software are designated as controlled areas that can only be
accessed by authorized personnel, such as Varian authorized service personnel
and physicists. Utilities are available for performing safety and maintenance
related functions, and for testing the system and measuring crucial parameters.
Refer to the “Define User Access and Location Information” section in
Chapter 4 “Introduction” for more information.

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Note: For safety reasons, only Varian authorized service personnel are
permitted to exit to the operating system from the control
software.

Start Page
The control software provides two major workflows and a comprehensive set
of system configuration options that you initiate from a single point — the Start
Page. This page is displayed automatically when you turn on the control PC.
The workflows and configuration options are represented by the Open Patient
File, Create New Patient File, and System Configuration buttons on the
Start Page. The Start Page also has a Shut Down button that enables you to
gracefully shut down the control software and power down the control PC.

The Start Page includes a graphical representation of the GammaMedplus iX


afterloader.

Note: If the control software is not in full console mode, indicators


such as “Test Mode” appear in the upper right and left hand
corners of the screen.

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Elements of a Page
Each page of the user interface is divided into a set of horizontal strips. Each
strip is devoted to either displaying or entering related sets of data, such as
patient demographic information, channel dwell information, and system 1
status. Some strips, such as the System Status Strip, are displayed on all pages
of the interface, providing constant information on the general status of the
system.

Strips can appear as “opened” or “closed”. A closed strip displays as a narrow


band with only one or two buttons. Pressing a button opens the strip, presenting
additional edit fields and other controls. In addition to strips, the user interface
contains wizards that step you through individual tasks, such as importing a
treatment file.

The sample screen below shows the Patient Selection Page.

User Information Strip

Patient Selection Strip

System Status Strip

Dates and times on any given page are displayed in standard ISO 8601 format
— yyyy-mm-dd for dates and hh:mm:ss for times. Numeric formats reflect
the settings chosen in the Windows Regional Settings dialog during system
configuration.

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Major Workflows
The workflows available from the Start Page are:

• Open Patient File


This workflow enables you to import a patient treatment file from a
planning system such as BrachyVision™, check the integrity of the plan
and modify it as needed, and send the plan to the afterloader to deliver
treatment.
• Create New Patient File
This workflow enables you to create a new patient treatment plan in the
control software and send the plan to the afterloader to deliver treatment.
• System Configuration
The system configuration options enable a user with appropriate access
privileges to set up new user accounts, set system preferences, and perform
quality assurance and other routine functions. These options also support
Varian authorized service personnel in such tasks as problem diagnosis
and wire replacement.

The workflows and system configuration options are described in detail in


subsequent chapters. Refer to Chapter 2 “Patient and Treatment Data” and
Chapter 3 “Delivery of Patient Treatment” for more information on the Open
Patient File and Create New Patient File workflows and to Chapter 4
“System Configuration” for more information on the System Configuration
options.

The User Login Page, which is displayed each time you press the Open
Patient File, Create New Patient File, or System Configuration button, is
described below.

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User Login Page

The User Login Page is the first page shown regardless of the selected
workflow. This page enables you to enter your username and password for
logging into the control software, specify the physical location of the 1
afterloader, change your password, and log out of the control software. The
current date and time are also displayed. The Workflow field indicates the
current workflow.

Note: The Key field contains a special-purpose numeric value. Under


certain circumstances, a user with non-service engineer
privileges can specify the key number to a Varian
BrachyTherapy service engineer and receive a single use
password with service engineer privileges. The password is
valid for one workflow only.
Note: If you change the Location on the User Login Page, the control
software displays a message indicating that the source strength
may need to be recalibrated. If the afterloader is moved to any
location outside the facility, the USNRC requires that prior to
patient treatment a full calibration be conducted. Each time the
unit is relocated, it must undergo full calibration. The control
software does not check to ensure the recalibration has been
completed. For countries other than the United States, check the
regulations set forth by the local Competent Authority.

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Enter Your Username and Password

Your administrator sets up user accounts in the system configuration options.


Enter your username in the Operator field. Press the Tab key, or click in the
Password field and enter your password. Press the Log On button or the Enter
key to log on.

Edit a Password

To change your password, press the Edit Password button and enter the
appropriate data in the Operator, Current password, New password, and
Confirm password fields of the Edit Password Strip. The password must be
between 4 and 15 characters in length with no spaces. Then press the Save
button. User names and passwords are set in the system configuration options
by your administrator.

Note: The first time you log into the control software, you must
change the password given to you by your administrator. You
will be prompted with a message. When you confirm the
message, the Edit Password Strip is displayed.

The Cancel button closes the Edit Password Strip without saving your
changes.

Choose a Location

For transportable devices, the Location drop-down list enables you to select
your current location from a list of locations that your administrator specifies
in the system configuration options.

Log onto or out of the System

Press the Log On or Log Out button.

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Note: If a treatment is not currently in progress, and no user activity


has been detected for a length of time set in the system
configuration options, you will be switched automatically to
secure system mode and, if the inactivity continues, logged off
the system. 1

Note: When you log on, the control software checks to see if there are
any reasons why you cannot deliver a patient treatment and
displays any relevant messages at the bottom of the screen.

System Status Strip


The System Status Strip displays critical data regarding the system status
during the entire time you are logged into the control software. This strip is
located at the bottom of every screen. The following indicators are included:

• Error code & class


This indicator changes color and displays the error code and class when an
error occurs.
• Cycles
This indicator displays the remaining active (A) and dummy (D) wire
cycles and updates every time a patient or test treatment is completed. If
the number of remaining cycles for either the active wire or dummy wire
is less than 10% of the maximum allowable cycles, the icon displays in red.
Refer to the ”Source and Dummy Wire Exchange” section of Chapter 6
”Functions Performed by Service Personnel” for more information on the
maximum allowable active and dummy wire cycles.

Note: If the number of active or dummy wire cycles cannot be


determined, either because of a pending error on the afterloader
or a communication problem, only the labels (A) and (D) appear
in the System Status Strip.

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• Days since last source exchange


This indicator is based on the Exchange Date setting on the Source
Exchange tab of the Source & Wire strip in the System Configuration
workflow. It shows how many days have passed since the last source
exchange. The number of days available for a given wire is 120. If the
number of days since the last exchange is greater than 90, the icon displays
in red, and a warning message pops up at user log on. After 120 days have
elapsed, you are prohibited from delivering treatments.
• Current source strength
This indicator shows the current strength of the source installed in the
device based upon the value specified in the system configuration options.

Important: Do not use the value of the Days since last source exchange to
calculate source decay. This value may not provide an accurate
calculation, since it decrements beginning with the date of
source wire installation. Refer to the ”Enter the Calibrated
Source Strength” section in Chapter 4 ”System Configuration”
and the ”Source Decay” and ”Transit Dose” sections in
Appendix B ”GammaMedplus iX Calculations” for more
information.

CAUTION: It is not possible to use the afterloader if either the Cycles or


Days since last source exchange limit has been exceeded.

Network Connectivity
The afterloader control software supports an optional connection to a local area
network. This connection enables you to access shared remote directories for
treatment plans, treatment tests, and treatment history. It also allows you to
back up the patient database to a backup server and print to a network printer.

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Chapter 2 Patient and Treatment Data

This chapter describes all of the processes involved in working with patient
and treatment data. The chapter is divided into three major sections:

• Open Patient File Workflow 2


This workflow enables you to import a patient treatment file from a
planning system such1as BrachyVision™, check the integrity of the plan
and modify it as needed, and send the plan to the afterloader to deliver
treatment.
• Create New Patient File Workflow
This workflow enables you to create a new patient treatment plan in the
control software and send the plan to the afterloader to deliver treatment.
• View and Edit Channel Data
The Channel View and Channel Edit Strips are located on the Treatment
Delivery Page. These strips enable you to view and edit channel data. This
process is the same for the Open Patient File and Create New Patient
File workflows.

In This Chapter

Topic Page
Open Patient File Workflow 2-2
Create New Patient File Workflow 2-24
View and Edit Channel Data 2-30

2-1
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Open Patient File Workflow


The Open Patient File workflow enables you to import a patient treatment file
from a planning system such as BrachyVision™, check the integrity of the
plan, modify the plan as needed, and send the plan to the afterloader to deliver
the treatment. You can also use this workflow to administer and deliver a plan
that was imported into the control software at some point in the past. The pages
that comprise this workflow, along with the set of tasks associated with each
page, are shown in the table below.

Table 2-1 Open Patient File Workflow

Location in the
Tasks
Control Software

User Login Page Log into the control software


Specify a location
Edit your password

Patient Selection Page Select or import a treatment file


Edit an active treatment record
Perform record maintenance
View and print reports

Fraction View Page Copy and add a fraction


Delete an undelivered fraction
Print a fraction report

Treatment Delivery Page View and edit channel data


Initiate a treatment
Review the Planned Treatment Report
Begin the treatment delivery
Monitor the treatment
Complete the treatment

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This “Open Patient File Workflow” section describes the tasks associated with
the Patient Selection and Fraction View Pages. The “View and Edit Channel
Data” section of this chapter describes how to view and edit channel data using
the Treatment Delivery Page. Chapter 3 “Delivery of Patient Treatment”
provides detailed information on the remainder of the tasks associated with the
Treatment Delivery Page. Refer to the section called “Overview of the
Afterloader Control Software” in Chapter 1 for information on the User Login
Page.
2

Select or Import a Treatment File


When you press the Open Patient File button on the Start Page and log into
the control software, the Patient Selection Page appears. By default, the User
Info, Patient Selection, and System Status Strips are open, and the Plan Import
Wizard Strip and Treatment Record Maintenance Strips are closed.

User Info Strip

Patient Selection Strip

Plan Import Wizard and


Record Maintenance
Strips (closed)

System Status Strip

The User Info Strip provides read-only data about who is currently logged into
the control software, including the Operator, Location, and Current date/
time. It also provides buttons for securing or logging out of the system.

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The Secure System button temporarily secures the system against


unauthorized use if you need to step away from the control PC. This feature
also safeguards confidential patient data in your absence. This page displays
the username of the person who secured the system and a password entry field.
Only the person who secured the system, an administrator, or a service
engineer can take the system out of secure system mode. After a period of time
specified in the system configuration options, the dialog times out and you are
automatically logged off.

Note: If a treatment is not currently in progress, and no user activity


has been detected for a length of time set in the system
configuration options, the control software automatically
switches to secure system mode.

Note: The Secure System and Log Out buttons are disabled if a
treatment is currently in progress.

The Patient Selection, Plan Import Wizard, and Treatment Record


Maintenance Strips are described below in the context of selecting or
importing a treatment file. Refer to the “System Status Strip” section in
Chapter 1 for more information on the System Status Strip.

The Patient Selection Page enables you to perform the following tasks:

• Select a patient treatment file from the control software database


• Edit an active treatment record
• Import a patient treatment file from a network drive, removable media, or
an ARIATM database
• Perform record maintenance
• View and print reports

Each of these tasks is described below.

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Select a Patient Treatment File

The Active treatment records database in the Patient Selection Strip is a


sortable table that displays information about patients currently defined in the
control software, along with their corresponding treatment data. The control
software stores the database on the local hard drive. The table displays only the
records for the location that you chose on the User Login Page. The data for
each record in the table enables you to properly identify the current patient and 2
treatment data.

You can click on a treatment record to select and highlight it in the table. Click
on the header of a field to sort the records in ascending or descending order
using the values in the selected field. By default, the records are sorted on
Console entry date and time in descending order. The Selected patient data
above the Active treatment records table displays additional demographic
data about the selected patient.

Note: You are only permitted to browse patient records for those
locations for which you have access rights. Your administrator
specifies your location or locations in the system configuration
options.

Edit an Active Treatment Record

You can edit Selected patient data by selecting a treatment record in the
Active treatment records table and pressing the Edit Record button. All
static fields (except the treatment file name) for the patient switch to editable
text boxes. Click on the field or fields you want to edit and make any necessary
changes. Press the Save Changes button to save your changes to the database
or the Cancel Changes button to discard the edits. You cannot perform any
other actions while an edit is in progress, except canceling or saving the edits.

Note: In order to edit patient records, you must have the Edit
treatment plan privilege, as assigned by your administrator.

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Note: The Edit Record button is not available if the Plan Import
Wizard or Treatment Record Maintenance Strip is open.

Note: The control software displays yellow text boxes for all required
fields throughout the user interface.

Import a Patient Treatment File


The control software supports the following types of treatment files:
• Files created in the control software (.xml format). You can import XML
files created on a different control PC as long as each control PC is
attached to the same model of afterloader.
• GammaWin™ files in .##g format (where ## represents a fraction number,
e.g., 02g) stored on a network drive, hard drive, or removable media
• Files created in the BrachyVision™ treatment planning system in .g12,
.##g, and .dcm (DICOM) format and stored on a network drive, hard drive,
or removable media
• Plan data created in the BrachyVision™ treatment planning system and
stored in an ARIA database. ARIA is a comprehensive information and
image management system that aggregates patient data into a single,
organized, oncology-specific medical chart.

WARNING 2-1:In order to ensure accurate dwell time scaling for treatments
delivered by the GammaMedplus iX system, BrachyVision™
must be set so that plans are based on nominal source activity
when storing treatment files in DICOM format. This
requirement also applies to plan data created in BrachyVision™
and stored in an ARIA database.

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When you press the Import Plan button at the bottom of the Patient Selection
Page, the Plan Import Wizard Strip opens. This strip steps you through the
process of importing a treatment plan file, including:

• Treatment File Selection


• Patient Data Verification
• Reconciliation with Existing Plans 2

Each task is described below.

Treatment File Selection

Your administrator specifies one or more file import locations in the system
configuration options. A location can be a network drive, local hard drive,
USB, or some other removable media. If ARIA integration is enabled, the
ARIA option also appears as a file import location.
When you press the File Location button, you see the current list of locations.
Choose the appropriate location for your treatment files.

Selecting Treatment Files from an ARIA Database

When you choose ARIA from the File Location list, the Plan Import Wizard
displays one of two pages, depending on the ARIA Communications Settings
in the system configuration options.
• If Enable ARIA integration and Enable appointment integration are
activated, the Plan Import Wizard displays an Appointments table listing
the appointments that match the most recent selection criteria. By default,
the table displays the appointments for the current date. The Appointments
table shows the following information: patient ID, patient name, machine
name, procedure, start time, end time, and status.
• If only Enable ARIA integration is activated, the Plan Import Wizard
displays the Change Patient Filter Page.

Note: “Appointments” in the context of treatment file selection refers


to records created in the resource scheduler in ARIA.

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Selecting Files with ARIA and Appointment Integration Activated

On the Appointments page, select the appropriate appointment and press the
Continue button. The control software displays a table of Plans associated
with the selected appointment. Choose the appropriate plan and press the
Continue button. Continue with the Plan Import Wizard until the plan is
imported.

Note: The Plan you select must have an APPROVED status.

Important: You cannot import a plan if a patient has multiple plans with the
same Plan ID. In this case, you must assign the plan of interest
a unique Plan ID in BrachyVision™ before the plan import
from ARIA is allowed.

On the Appointments Page, the No Appointment and Change Filter buttons


enable you to change the selection criteria for the records retrieved from ARIA.
• No Appointment button — The No Appointment button enables you to
bypass appointments and query patient plans directly. Press this button and
enter a Patient ID1 or Last Name. Press the Continue button to display all
of the patients for the matching Patient ID1 or Last Name. If you press the
Continue button without entering a Patient ID1 or Last Name, the control
software retrieves all of the patients from the ARIA database. In the
Patients table, select the record with the appropriate Patient ID1. When
you press the Continue button on the Patients page, the Plan Import
Wizard displays a table of Plans associated with the selected patient.
Choose the appropriate plan and press the Continue button. Continue with
the Plan Import Wizard until the plan is imported.
• Change Filter button — The Change Filter button enables you to specify
one or more criteria and retrieve all of the appointments that match that
criteria. Press the button and enter or select data for one or more of the
fields (Patient ID1, Machine name, Start date, End date, Status) and press
the Continue button to retrieve the matching appointments. Select a record
from the list of appointments and press the Continue button to display a
table of Plans associated with the selected patient. In the Plans table, select
the appropriate plan and press the Continue button. Continue with the Plan
Import Wizard until the plan is imported.

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Selecting Files with Only ARIA Integration Activated

When only the Enable ARIA Integration check box is activated in the system
configuration options, the Plan Import Wizard displays the Change Patient
Filter Page where you can use a Patient ID1 or Last Name to query the patient
plans directly. See the description of the No Appointment button above for
more information.
2
Note: If the current search does not display the record of interest, you
can press the Change Filter button again and enter new search
criteria.

Selecting Treatment Files from Network Drives, Hard Drives, or


Removable Media

For all treatment files in locations other than the ARIA database, the Plan
Import Wizard displays a table containing information about each treatment
file in the currently selected location. The table shows the following
information: patient ID, patient name, treatment site, treatment file name, and
file date.

Note: The filenames for files that do not pass initial validity checks
upon import are pre-pended with an exclamation point (!).
Select the file in the plan import table and press the Continue
button to view an error message that describes the problem.

Choose the patient file of interest from the table and press the Continue button.

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Continuing with Treatment File Selection

The Continue button performs a check on the data to verify that the treatment
parameters are within the operational limits of the afterloader. The verification
includes the number of channels, the number of dwell positions within each
channel, the spacing between dwell positions, and the channel length. If the
treatment file does not meet the verification requirements, a validation error
message is displayed.

If the treatment file is missing the patient ID, an error message is displayed and
the file cannot be imported. If a treatment file you want to import shares the
same name as a treatment file in the Active treatment records database, a
warning message is displayed before you can proceed. To avoid importing the
same file twice, the control software deletes the treatment file from its original
location if possible when you press the Continue button.
There is no limit on the number of patient treatment files that can be imported
and displayed in the Plan Import Wizard or the number of patient records that
can reside in the Active treatment records database. The maximum number
of patient files is limited only by the available hard disk space on the local
drive.

The Plan Import Wizard also displays buttons for deleting a treatment plan file,
canceling the import, and continuing to the next page of the wizard.
When you select a treatment file, the Continue and Delete File buttons are
enabled, and if a corresponding record for the selected plan already exists in
the database, the record is highlighted in the active treatment records table. The
Delete File button displays a confirmation message before the deletion takes
place.

Important: A deleted file is removed from the selected file location and
cannot be recovered unless you have stored a copy of it
elsewhere.

The Cancel Import button closes the Plan Import Wizard Strip without
importing any treatment files.

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Patient Data Verification

The Data Verification Page of the Plan Import Wizard appears after you
select a treatment file and press the Continue button. This page contains the
read-only patient ID and editable text boxes for last and first names.

The Last name is a required field, and the First name is optional. If possible,
these fields are populated with data from the treatment file currently selected
for import. If data is missing from the selected file, the fields are populated
with data from the patient database if a record exists for the patient ID.

The buttons displayed on the Data Verification Page depend on whether or not
you have previously imported a treatment file for a particular patient ID. If this
is the first plan import for an ID, the Cancel Import, Previous, and Done
buttons appear. Otherwise, a Continue button appears in place of the Done
button.

The Cancel Import button closes the Plan Import Wizard Strip without
importing any treatment files. The Previous button returns to the previous
page of the Plan Import Wizard. The Done button completes the plan import
and updates the Active treatment records database.
If this is the first plan import for a particular patient, click on the field or fields
you want to edit, make any necessary changes, and press the Done button to
close the Plan Import Wizard. The new treatment record appears and is
highlighted in the Active treatment records database.

If data already exists in the Active treatment records database for the patient
ID whose treatment file you are importing, make any necessary edits in the text
boxes and press the Continue button. If you make changes to the Last name
or First name, a message appears asking you to confirm if you would like to
use the new values. The next section, “Reconciliation with Existing Plans”,
describes your options for reconciling the record you are importing with the
record that already exists for the patient ID.

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Reconciliation with Existing Plans

When you press the Continue button on the Data Verification Page of the Plan
Import Wizard, the Data Reconciliation Page appears with two option buttons:

The first option adds the imported plan to the most recent course of treatment
for the patient. When the import is completed, the Delivery status column in
the Active treatment records table is updated to reflect the added fraction.
The second option makes the imported plan the first fraction of a new course
of treatment for this patient. When the import is completed, a new record
appears and is highlighted in the Active treatment records database. The
Delivery status column in the plan database shows 0 of x fractions for this
plan, where x is the total number of fractions specified in the treatment file.

Note: If the imported plan has been exported from the control
software (.xml format) and contains one or more fractions that
have already been delivered, only the second option above is
available.

Choose an option and then press the Done button to complete the import and
close the Plan Import Wizard.

Perform Record Maintenance


The Treatment Record Maintenance Strip opens when you press the Record
Maintenance button on the Patient Selection Page.

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There are three types of record maintenance tasks you can perform:

• Change the activation status of a record


• Export a treatment file
• Delete a record

2
Note: In order to perform record maintenance, you must have the Edit
treatment plan privilege, as assigned by your administrator. If
you do not have this privilege, the Record Maintenance button
is disabled.

For each type of task, you can select one or more records. Select a single record
by clicking on it in the database table. You can select a group of adjacent
records by highlighting the first record, pressing and holding down the Shift
key, and then highlighting the last record. To select a group of non-adjacent
records, highlight one, then press the Ctrl key and hold it down while you
individually highlight all the other records you want for the group.

Change the Activation Status of a Record

The control software enables you to designate the status of a record as Active
or Inactive. The active status is used for courses of treatment that are currently
in progress. Active records are displayed in the Active treatment records
table. The inactive status is used for courses of treatment that are either
complete or dormant. Inactive records are displayed in the Inactive treatment
records table.
You can change the status of a record and toggle between the Active and
Inactive treatment records tables using the Activation status group box of
the Treatment Record Maintenance Strip. Press the Record Type button and
select the Active or Inactive option to toggle between the two tables.

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Follow these steps to change the status of a record to inactive:

1. Select one or more records in the Active treatment records table.


2. Press the Make Inactive button to change the status of the selected
record(s) to inactive. A confirmation message appears.
3. Confirm the message and select the Inactive option from the Record Type
list to view the records in the Inactive treatment records table.

Follow these steps to change the status of a record to active:

1. Select one or more records in the Inactive treatment records table.


2. Press the Make Active button to change the status of the selected record(s)
to active. A confirmation message appears.
3. Confirm the message and select the Active option from the Record Type
list to view the record in the Active treatment records table.

Export a Treatment File

The export function enables you to copy one or more selected treatment files
to a specified directory. Plans exported in this way can be used as back up
copies or reimported into another control PC using the Plan Import Wizard.
You can export files from the Active treatment records or the Inactive
treatment records table. Your administrator designates one or more Export
Locations in the control software system configuration options. You use the
Export group box in the Treatment Record Maintenance Strip to select an
Export Location and initiate the export.

Note: If your administrator has not set up an Export Location, the


Export button will be disabled.

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Follow these steps to export a treatment file:

1. Press the Export Location button and select the appropriate export
directory from the drop-down list. By default, the Export Location list
displays the most recently used export directory.
2. Highlight the record or group of records you want to export in the Active
or Inactive treatment records table and press the Export button. A 2
confirmation message is displayed when the export is complete.
The export function creates one XML file for each treatment file you export.
The name of the XML file is the treatment file name displayed on the Patient
Selection Page. The Modified date for the exported file reflects the date the file
was created in the control software. You can import the XML file back into the
control software by selecting the export file location in the Plan Import Wizard,
providing your administrator has configured your import file location this way.

Note: XML files are text files that are readable in any text editor. Use
due diligence to ensure that patient identification information
and other sensitive data are protected.

Delete a Record

The Delete Record button in the Treatment Record Maintenance Strip is


enabled when you select a record in the Active or Inactive treatment records
table. You can delete one or more records at a time. When you press the Delete
Record button, a confirmation message is displayed before the deletion takes
place.

Note: A deleted record is removed from the database and cannot be


recovered unless it was previously exported. For more
information on exporting files, refer to the “Export a Treatment
File” section above.

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View and Print Reports

The Report Page and report format are similar for all reports in the control
software. Under the title of each report is an information line that includes the
name of the user logged on at the time the report is printed, clinic (facility
name, if available), machine serial number, and the date and time the report is
printed. Each report (except Data Disclosure) displays the patient name and
fraction number (if applicable) in the page header and the type of afterloader,
version and build number of the control software, and firmware version of the
afterloader in the page footer.

The Report Page for all reports in the control software includes a number of
buttons that enable you to navigate a report, including First, Previous, Next,
and Last buttons. Options for printing the report are also included — Entire
Document, Current Page, and Page Range.

The Save to File Option enables you to save a report in PDF format. Press the
File Location button and select a folder from the list. Folder locations are
designated in the Folder Setup tab of the User & Location strip in System
Configuration. Press the Save button to save the file.

Press the Print button to print a hard copy of a report and the Close button to
close the report and return to the current page.

You can view and print patient Data Disclosure and Treatment History Reports
for a selected record using the buttons in the Reports box on the Patient
Selection Page.

When you press the Data Disclosure button, the Data Disclosure Report for
the selected record appears. This report tracks all changes made to the patient
demographic data for a particular treatment file since it was imported into the
control software. The report is divided into two main sections — Patient/
Treatment Data and Access History. The Patient Data includes Patient Last
Name, Patient First Name, Patient Identification, Sex, and Patient Birthdate.

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The Plan Data includes Total Planned Fractions, Physician, Treatment Site,
Applicator, and Plan File. The Access History describes each time the record
was changed. The Access History table includes:

• Date and time the patient record was accessed


• Login ID of the person accessing the record (User)
• A description of the information accessed or changed, with old and new 2
values for the data item; also indicates if a hard copy of the report was
printed

When you press the Treatment History report button, the Treatment History
Report appears. This report tracks the details of the treatments delivered to the
patient. Each report contains a summary page consisting of Patient/ Treatment
Data and a Treatment Summary. The Patient/ Treatment Data summary section
includes Patient Data (Patient Last Name, Patient First Name, Patient
Identification, Sex, and Patient Birthdate) and Plan Data (Total Planned
Fractions, Physician, Treatment Site, Applicator, and Plan File).

The Treatment Summary section provides summary information for each


fraction, including the Fraction Number or Matching Fraction, Console Entry
Date, Plan Author, and Delivery Status.
Following the summary page, the report is divided into the following main
sections for each fraction — Patient/ Treatment Data, Planned/ Actual
Comparison, Treatment Details, and Source Data.
In the Patient/Treatment Data section, the Patient Data includes Patient Last
Name, Patient First Name, Patient Identification, Sex, and Patient Birthdate.
The Plan Data includes Fraction, Physician, Treatment Site, Applicator, Plan
File, Plan Author, and Console Entry Date. The Delivery Data (if available)
includes Delivery Status, Decay Scale Factor, Operator, Delivery Date, Start
Time, and End Time.
The Planned/ Actual Comparison section includes a table comparing the
Planned and Actual values (if available) for Source Strength, Total Time, and
Total Curie seconds (Ci-s)/GBq-s/Total air kerma strength, indicating the
Difference and Percent Difference for each value. The system units for source
strength are designated in the system configuration options.

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The Treatment Details include the Channel Length, Dwell Positions (total),
Planned Time, Scaled Time, Delivered Time, Remaining Time, and a table
showing the dwell Positions, Planned dwell times, Scaled dwell times, and
Delivered dwell times for each channel.

The Source Data section includes the Remaining Active Wire Cycles,
Remaining Source Days, Calibration Date, and Wire Serial number.

If the treatment was interrupted for any reason, an additional Interruption Data
section is included for each fraction. This section includes Time of
Interruption, error Code, error Class, error Description, Channel number,
Dwell Location, Time Spent at Dwell, and Continuation Option.

Continue to the Fraction View Page

When you are finished with the Patient Selection Page, press the Proceed
button to display the Fraction View Page, where you can view and modify
fractions.

Note: You cannot proceed to the next page if the Plan Import
Wizard or Treatment Record Maintenance Strip is open.

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View and Modify Fractions


The Fraction View Page enables you to view data about delivered fractions or
about a fraction that is about to be delivered. You can also delete planned
fractions or copy and add additional ones. The Fraction View Page consists of
the User Info Strip, Patient Info Strip, Fraction View Strip, and System Status
Strip.
2
User Info Strip
Patient Info Strip

Fraction View Strip

System Status Strip

The User Info Strip provides read-only data about who is currently logged into
the control software, including the Operator and Location. It also provides
buttons for securing or logging out of the system. The Secure System and Log
Out buttons are disabled when a treatment is in progress. Refer to the “Select
or Import a Treatment File” section in this chapter for information on the
Secure System button.

The Patient Info Strip provides read-only data on the currently selected patient,
including Patient, Patient ID, Birth date, Treatment site, and Physician. Refer
to the “System Status Strip” section in Chapter 1 for more information on the
System Status Strip.

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The top of the Fraction View Strip provides data on the currently selected
fraction, including the following fields:

• Fraction — the number of the currently selected fraction and the total
number of fractions for this plan (read-only field)
• Planned strength — the source strength assumed by the planning system
when determining dwell times. Scaled dwell times are adjusted at delivery
time according to the current source strength. (read-only field)
• Operator — for fractions whose Delivery status is Complete, the name
of the person logged on when the treatment is delivered; for a fraction that
has not been delivered, the field is blank
• Planned by — the ID of the person who created the plan (editable field)
• Applicator — the applicator specified in the treatment plan (if any)
(read-only field)

Note: The unit value for Planned strength is set by your


administrator in the system configurations options.

The middle of the Fraction View Strip displays the Fraction View Table, which
includes the following information for each fraction:

• Fraction — the number of the fraction


• Matches — indicates if a fraction matches an earlier fraction
• Console entry date — the date the fraction was imported into or created
in the control software
• Date delivered — the date the fraction was delivered
• Start time — the time the fraction delivery began
• End time — the time the fraction delivery ended
• Delivery status — indicates if the delivered fraction was complete or
aborted

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The Fraction View Page enables you to perform the following tasks:

• Copy and add a fraction


• Delete an undelivered fraction
• Print a fraction report
• Save or cancel changes 2
• Return or advance to a different page

Each of these tasks is described below.

Copy and Add a Fraction

You can copy an existing fraction and add the copy to the end of the list of
fractions in the Fraction View Table. Select the fraction you want to copy in
the table and press the Copy and Add Fraction button. The new fraction
appears in the table, and the data in the fields at the top of the strip is updated
accordingly. The Matches field indicates which fraction was used for the copy.
The new fractions are not added to the database until you press the Save button.

Delete an Undelivered Fraction

You can delete an undelivered fraction by selecting it in the Fraction View


Table and pressing the Delete Fraction button. The selected fraction is
removed from the table. The fraction is not deleted from the database until you
press the Save button. To undo the deletion, press the Cancel button.

Note: You cannot delete a delivered fraction. When you select a


delivered fraction, the Delete Fraction button is disabled.

Print a Fraction Report

When you press the Print Fraction Report button, the Selected Fraction
Report appears. This report provides details for the selected fraction. The
report is divided into the following main sections — Patient/ Treatment Data,
Planned/ Actual Comparison, Treatment Details, and Source Data.

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In the Patient/ Treatment Data section, the Patient Data includes Patient Last
Name, Patient First Name, Patient Identification, Sex, and Patient Birthdate.
The Plan Data includes Fraction, Physician, Treatment Site, Applicator, Plan
File, Plan Author, and Console Entry Date. The Delivery Data (if available)
includes Delivery Status, Decay Scale Factor, Operator, Delivery Date, Start
Time, and End Time.

The Planned/ Actual Comparison section includes a table comparing the


Planned and Actual values (if available) for Source Strength, Total Time, and
Total Curie seconds (Ci-s)/GBq-s/Total air kerma strength, indicating the
Difference and Percent Difference for each value. The system units for source
strength are designated in the system configuration options.

The Treatment Details include the Channel Length, Dwell Positions (total),
Planned Time, Scaled Time, Delivered Time, Remaining Time, and a table
showing the dwell Positions, Planned dwell times, Scaled dwell times, and
Delivered dwell times for each channel.

The Source Data section includes the Remaining Active Wire Cycles,
Remaining Source Days, Calibration Date, and Wire Serial number.

If the treatment was interrupted for any reason, an additional Interruption Data
section is included at the end of the report. This section includes Time of
Interruption, error Code, error Class, error Description, Channel number,
Dwell Location, Time Spent at Dwell, and Continuation Option.

Press the Print button to print a hard copy of the report or the Close button to
close the report and return to the Fraction View Page.

Save or Cancel Changes

When you press the Cancel button, all additions and deletions to the Fraction
View Table performed since the last save are undone.

When you press the Save button, all information displayed in the Fraction
View Table is written to the treatment history file for the selected patient,
including current modifications.

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Return or Advance to a Different Page

The Previous and Proceed buttons enable you to return to the Patient
Selection Page or advance to the Treatment Delivery Page. If you use the Copy
and Add Fraction button or Delete Fraction button, the Previous and
Proceed buttons are disabled until you Cancel or Save your changes.
When you press the Proceed button, the control software performs an integrity 2
check on the selected fraction to ensure it will run properly on the attached
afterloader and displays a validation error if necessary.

Note: You cannot proceed to the Treatment Delivery Page if the


delivery status of the selected fraction is Completed.

Refer to the “View and Edit Channel Data” section at the end of this chapter
for information on how to view and edit channel data using the Treatment
Delivery Page, or to Chapter 3 “Delivery of Patient Treatment” for detailed
information on delivering a treatment for the selected fraction.

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Create New Patient File Workflow


The Create New Patient File workflow enables you to create a new patient
treatment plan in the control software without importing it from a treatment
planning system. The plan consists of patient demographic data, fraction data,
and channel dwell positions and times. The plan can be used to deliver a
treatment or saved and retrieved later using the Open Patient File workflow.

The Create New Patient File workflow also enables you to use a standard plan
as a model or starting point for a new plan. Standard plans are created using the
system configuration options and can be selected on the Fraction Creation Page
in the Create New Patient File workflow.

The pages that comprise this workflow, along with the set of tasks associated
with each page, are shown in the table below.

Table 2-2 Create New Patient File Workflow

Location in the
Tasks
Control Software

User Login Page Log into the control software


Specify a location
Edit your password

Patient Creation Page Enter patient data

Fraction Creation Page View and define fraction data


Use a standard plan as a model

Treatment Delivery Page View and edit channel data


Initiate a treatment
Review the Planned Treatment Report
Begin the treatment delivery
Monitor the treatment
Complete the treatment

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This “Create New Patient File Workflow” section describes the tasks
associated with the Patient Creation and Fraction Creation Pages. The “View
and Edit Channel Data” section of this chapter describes how to view and edit
channel data using the Treatment Delivery Page. Chapter 3 “Delivery of
Patient Treatment” provides detailed information on the remainder of the tasks
associated with the Treatment Delivery Page. Refer to the section called
“Overview of the Afterloader Control Software” in Chapter 1 for information
on the User Login Page.
2

WARNING 2-2: While you can create new patient treatment plans using the
Create New Patient File workflow, the afterloader control
software does NOT perform any dosimetric calculations related
to the determination of the proper treatment plan except for
computing source decay. Be sure to check the integrity and
clinical accuracy of any data that you enter before delivering a
treatment. Failure to do so may result in incorrect treatment and
may cause serious injury to the patient.

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Enter Patient Data


When you press the Create New Patient File button on the Start Page and log
into the control software, the Patient Creation Page appears. The Patient
Creation Page enables you to enter data for a patient who is not currently
defined in the treatment records database. The Patient Creation Page consists
of the User Info Strip, Patient Creation Strip, and System Status Strip.

User Info Strip

Patient Creation Strip

System Status Strip

The User Info Strip provides read-only data about who is currently logged into
the control software, including the Operator and Location. It also provides
buttons for securing or logging out of the system. The Secure System and Log
Out buttons are disabled when a treatment is in progress. Refer to the “Select
or Import a Treatment File” section in this chapter for information on the
Secure System button.

The Patient Creation Strip enables you to enter patient demographic data. This
strip is described in detail in the following sections. Refer to the “System
Status Strip” section in Chapter 1 for more information on the System Status
Strip.

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You can specify the following patient data using the editable text boxes and
drop-down lists in the Patient Creation Strip:

• First name — enter the first name using up to 40 characters


• Second name — enter an optional middle name using up to 40 characters
• Last name — enter the last name using up to 40 characters
2
• Birth date — enter the date in (yyyy-mm-dd) format
• Sex — choose the patient sex. By default, the patient sex field is
Unspecified.
• Patient ID1 — enter the first patient ID using up to 40 characters
• Patient ID2 — enter an optional second patient ID using up to 40
characters
• Treatment site — select an item from the pull-down list. By default, the
treatment site is Unspecified.
• Physician — enter an identifier for the physician using up to 40 characters.
If your site has a record and verify system, you might want to enter the
physician ID as defined in that system, since using the same physician ID
maintains consistency and may avoid confusion, e.g. for physicians with
the same last name.

The patient First name, Last name, and Patient ID1 fields are required. When
you have entered data in these fields, the Proceed button is enabled. When you
have finished entering data in the Patient Creation Page, press the Proceed
button to continue to the Fraction Creation Page.

When you press the Proceed button, the database is queried to see if a patient
with the specified ID already exists. If so, a warning is issued indicating that
the plan about to be created will constitute a new course of treatment for this
patient.

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View and Define Fraction Data


The Fraction Creation Page enables you to view and define basic fraction data
for a plan. The Fraction Creation Page consists of the User Info Strip, Patient
Info Strip, Fraction Creation Strip, and System Status Strip.

User Info Strip

Patient Info Strip

Fraction Creation Strip

System Status Strip

The User Info Strip provides read-only data about who is currently logged into
the control software, including the Operator and Location. It also provides
buttons for securing or logging out of the system. The Secure System and Log
Out buttons are disabled when a treatment is in progress. Refer to the “Select
or Import a Treatment File” section in this chapter for information on the
Secure System button. The Patient Info Strip provides read-only data on the
currently selected patient, including patient name, patient ID, birth date,
treatment, and physician.

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Enter Fraction Data

You can specify the following fraction data using the editable text boxes and
drop-down lists in the Fraction Creation Strip:

• Number of fractions — enter this value, up to a maximum of 50 fractions


(value must be a whole number)
• Planned strength — enter the source strength on which you are basing 2
dwell times. The allowed values for planned strength depend on what is
permitted by the attached afterloader. Scaled dwell times will be adjusted
at delivery time according to the current source strength. If you select a
standard plan, the planned strength is derived from the selected plan, and
this field becomes read-only.
• Applicator — optionally, select the applicator to use for the treatment.
Your administrator configures the list of applicators in the system
configuration options.
• Standard plan — optionally, select a standard plan to use as a starting
point for the treatment. Your administrator creates the standard plans in the
system configuration options. If you select an applicator, you see only the
standard plans that use that applicator; if you do not select an applicator,
you see the entire list of standard plans.

Note: The unit value for Planned strength is set by your


administrator in the system configurations options.

The Number of fractions and Planned strength fields are required. Once you
have entered data in these fields and pressed the Save button, the Proceed
button is enabled. Once you press the Save button, the Previous button is
disabled.

When you have finished entering data in the Fraction Creation Page, press the
Proceed button to continue to the Treatment Delivery Page. The control
software validates all editable fields to ensure they fit within allowed
constraints.

Refer to the “View and Edit Channel Data” section below for information on
how to view and edit a channel using the Treatment Delivery Page, or to
Chapter 3 “Delivery of Patient Treatment” for detailed information on
delivering a treatment for the selected fraction.

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View and Edit Channel Data


The Treatment Delivery Page enables you to perform all of the tasks associated
with delivering and monitoring patient treatments. You perform these tasks the
same way for the Open Patient File and Create New Patient File workflows.

The tasks include:

• View and edit channel data


• Initiate a treatment
• Review the Planned Treatment Report
• Begin the treatment delivery
• Monitor the treatment
• Complete the treatment

This section describes how to use the Treatment Delivery Page to view and edit
channel data. Refer to Chapter 3 “Delivery of Patient Treatment” for detailed
information on each of the other tasks in the list above.

By default, the Treatment Delivery Page consists of the User Info, Patient Info,
Fraction Info, Channel View, Treatment Initiation, Channel Edit, and System
Status Strips. The Treatment Delivery Strip is available once you initiate a
treatment. The Partial Treatment Strip becomes available if a treatment is
cancelled or interrupted for any reason.

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User Info Strip

Patient Info Strip

Fraction Info Strip


Channel View Strip
2

Treatment initiation Strip

Channel Edit Strip

System Status Strip

This section focuses on the Channel View and Channel Edit Strips.

The Channel View Strip


The Channel View Strip provides read-only data on the channels and dwell
positions for the fraction about to be delivered. This strip is always open. The
strip contains a table listing each channel in the current fraction with a
graphical representation of each channel, a set of fields summarizing treatment
data for this fraction, and the Previous and Initiate Treatment buttons.

Note: For BrachyVision™ users: Names provided for channels in


BrachyVision are not included in the plan export file if the
export file format is .g12 or .##g. If you imported the patient
treatment plan from BrachyVision, the Channel name field in
the Channel View Strip will not display data. Refer to the “The
Channel Edit Strip” section below for information on how to
add channel names in the channel editor. Channel names are
included for exported files in DICOM format.

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You can click on a channel to select and highlight it in the Channel View Strip.
You can use the Up and Down arrow keys and the Page Up and Page Down
keys on the keyboard to move up and down through the channels and select
them. A vertical scroll bar appears if necessary and enables you to scroll
through all of the channels.

Important: Depending on a number of factors, including the number of


dwell positions, step size, and the location of the first dwell
position, all of the planned dwell positions may not be visible in
a particular channel at once. Left and right scroll buttons appear
at the top of the graphical representation when necessary,
indicating that some of the dwell positions are not shown for a
particular channel. These buttons enable you to scroll
horizontally through the channel.

When you open the Treatment Delivery Page, by default, the control software
ensures that the most distal dwell position of the first occupied channel is
visible in the Channel View Strip. For other channels, if the proximal and distal
dwell positions are within the viewable range, the display marks these two
positions, as seen in Channel 03 below. If either position lies outside the
current viewable range, small black numbers indicate the left and/or right-most
boundary of this range, as seen in Channel 04 below.

Dwell points are shown as histogram bars within the graphical representation
of each channel, where the height of the bar indicates the total planned time at
that position. Refer to the “Deliver and Monitor the Treatment” section of
Chapter 3 “Delivery of Patient Treatment” for detailed information on the
appearance of the channel representation and the values for the read-only fields
during treatment delivery.

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Upon initial entry, the Channel View Strip shows the dwell times as specified
in the treatment plan. Once you press the Initiate Treatment button, the
planned dwell times are updated to scaled dwell times based on current source
strength. Refer to the “Deliver and Monitor the Treatment” section in
Chapter 3 “Delivery of Patient Treatment” for more information on initiating
a patient treatment.
2
The Channel Edit Strip
The Channel Edit Strip opens when you press the Edit Channel button on the
Treatment Delivery Page. This strip enables you to add and delete channels
from a selected fraction and add, delete, and modify dwell positions and times
within a selected channel. This section describes how to edit a channel using
the Channel Edit Strip. Refer to the “Deliver and Monitor the Treatment”
section in Chapter 3 for detailed information on the other tasks associated with
the Treatment Delivery Page.

Note: For the Create New Patient File workflow, if there are no
dwell positions currently defined, the Channel Edit Strip opens
automatically when you access the Treatment Delivery Page.

Components of the Channel Edit Strip

The Channel Edit Strip consists of text boxes, static text, buttons, and a
graphical representation of the dwell positions and times in the current
channel.

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Text Boxes

The following text boxes are included in the Channel Edit Strip:

• Name — enter the name of the channel. When you press the Save button,
the Channel name is displayed in the first column of the Channel View
Strip.
• Length (cm) — a read-only field specifying the length of the channel
(which is fixed at 130 cm for all channels of the GammaMedplus iX)
• Step size (cm) — enter the step size in cm between the range of 0.1 and
1.0 cm. The control software accepts only 1 decimal place.

Important: There is no default step size setting for unplanned channels, i.e.,
channels that you add using the Channel Edit Strip. You must
enter a step size before you can add any dwell positions when
creating new plans or adding new channels to an existing plan.

Note: When you change the step size for a selected channel, if one or
more adjacent distances is not a multiple of the new step size,
all of the dwell positions within the channel will be erased, and
you will be required to re-enter them by hand. The control
software displays a confirmation message before the dwell
positions are erased.

• Origin (cm) — You can change the distal position of the source separately
in each channel to adjust for patient anatomy. Select the channel you want
to modify, and enter the offset from the distal position in the Origin field.
A value of 0.0 cm represents the full 130.0 cm channel length; a value of
20.0 cm represents a 20.0 cm offset from the 130.0 channel length, or a
110.0 cm distal position. As an alternative, you can press the Origin button
at the bottom of the Channel Editor, and follow the prompts at the bottom
of the screen. Refer to the “Change the Distal Position of the Source”
section below for more information.

Note: The offset value must be in the range of 0.0 to 40.0 cm with a
resolution of 0.1 cm.

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Static Text

The following static text is included in the Channel Edit Strip:

• Dwell time scale (s) — the maximum dwell time currently set for any
single position in the current channel
• Total dwell time (s) — the sum of the dwell times for all of the dwell
positions set for the current channel
2
• Total dwell positions — the total number of dwell positions set for the
current channel, up to a maximum of 60

Channel Representation

The current channel is displayed as a series of vertical bars, with each bar
representing a dwell position. The Channel number appears on the left side
of the channel representation. At both ends of the channel representation are
Directional scroll buttons.

Channel Number Dwell Selector

Boundary Lock Button Dwell Selector Range


Directional Scroll Buttons

The Dwell Selector enables you to view and enter the dwell times for the dwell
positions in the channel. The Dwell Selector Range contains a Boundary
Lock button that enables you to secure the treatment range and designate the
allowable left and right boundaries for the dwell selector. These tools are
discussed in detail in the next section.

The up and down arrows enable you to scroll up and down through the set of
available channels in the current fraction. When you click on an arrow, the
Channel number updates to indicate the current channel. The selected
channel is highlighted in the Channel View Strip. You can also select and
highlight a channel by clicking on it in the Channel View Strip.

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The left and right arrows enable you to scroll left and right through the dwell
positions. Each time you click on an arrow, the Dwell Selector moves one
position in the direction you choose according to the current step size. You can
also use the left and right arrow keys on your keyboard to scroll left and right
or the Enter key. Refer to the “Move the Dwell Selector” section below for
more information.

The page left and page right arrows enable you to page a full view at one time.
If the boundary lock is open, you can page to the end of the channel. If the lock
is closed, you can page as far as the first or last dwell position.

The Channel Edit Strip enables you to perform the following tasks:

• Edit a channel
• Copy and paste channel data
• Change the distal position of the source
• Delete a channel
• Save or cancel changes

Each of these tasks is described below.

Edit a Channel

In addition to using the text boxes to edit a channel, you can use the Dwell
Selector to create or modify dwell positions and the buttons at the bottom of
the Channel Edit Strip to Copy, Paste, and Delete channel data.

Create or Modify a Dwell Position

The Dwell Selector enables you to view dwell time and dwell position settings
for existing dwell points and to create new dwell positions within the current
channel.

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Dwell Time

Dwell Time Lock Scroll Handle

Dwell Point

2
Dwell Position

Important: If the most distal dwell position is set at the end of the channel
(130 cm), the Channel View and Channel Edit strips will
display this position at 130 cm, but the actual treatment position
will be 129.9 cm, due to a 1 mm offset from the end of the
channel.

Move the Dwell Selector

There are several ways to move the Dwell Selector along the length of the
channel representation. You can click on the scroll left and right buttons in the
Channel Edit Strip. You can also click once on the channel representation and
then use the left and right arrow keys on the keyboard to scroll left and right.

As you move the Dwell Selector to each adjacent Dwell Point, the Dwell
Position at the bottom of the selector updates according to the designated step
size. The Dwell Point number also updates with each position. The
GammaMedplus iX system supports up to 60 dwell positions per channel.

Note: The dwell positions are numbered from 1 to 60 starting from the
most distal position.

You can click on the Scroll Handle in the top right corner of the Dwell
Selector and hold down the mouse button as you drag the selector to the
position you want. When you click on a dwell position, the Dwell Selector
snaps to that position.

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When entering dwell times, you can also use the Enter key to move the Dwell
Selector one position at a time to the left or right. The direction (left or right)
depends on the direction last used with the scroll left and right buttons or the
scroll handle.

Enter a Dwell Time

To enter or modify a Dwell Time, click on the Dwell Time Lock to change the
status to unlocked. Enter the dwell time in seconds in the Dwell Time field,
using one decimal place if necessary. The dwell time must be between 0.10
seconds and 9999.9 seconds.

Important: There are additional limitations on the minimum usable dwell


times allowed depending on the distance between dwell
positions. These restrictions are not managed in the Channel
Editor because they are based on scaled dwell times. Refer to
the “Minimum Dwell Time Restrictions” section in Appendix B
“GammaMedplus iX Calculations” for information on minimal
dwell times that will allow correct operation.

Dwell times are not saved in the control software database until you press the
Save button, at which time the Channel Edit Strip closes and the changes are
displayed in the Channel View Strip.

Note: If you enter a Dwell Time in the Dwell Selector that exceeds
the current Dwell Time Scale, the control software readjusts the
scale of all of the dwell positions in the channel representation
when you press the Enter key or the Dwell Time Lock. The
new dwell time is displayed in the Dwell Time Scale field, and
the height of the displayed dwell times is normalized to this new
maximum value.

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Lock or Unlock the Dwell Selector Range

If the currently selected channel has at least one designated dwell position, the
Dwell Selector Range appears at the bottom of the channel representation.
When two or more dwell points are designated, the Dwell Selector Range
displays the right and left most dwell positions in the channel in cm.

When the Boundary Lock button is unlocked, you can scroll the dwell selector
outside the boundaries of the dwell selector range. When the Boundary Lock
button is locked, you can only scroll the dwell selector within the dwell selector
range. Click on the lock to toggle the status.

Copy and Paste Channel Data

You can copy and paste all of the dwell positions from one channel to another.
First, select the channel whose data you want to copy by highlighting the
channel in the Channel View Strip or using the up and down arrows in the
Channel Edit Strip. Then press the Copy button. The control software displays
a confirmation message. After you confirm the message, select the channel to
which you want to copy the data and press the Paste button. The control
software displays a confirmation message again. Confirm the message. The
copied data appears in the channel representation of the Channel Edit Strip.
When you press the Save button, the Channel Edit Strip closes and the updated
channel data appears in the Channel View Strip.

Note: If the copied channel has a Channel Name, this name is not
pasted into the new channel; instead, the Name field is left
blank.

Change the Distal Position of the Source

You can change the distal position (origin) of the source separately in each
channel to adjust for patient anatomy once the applicator is inserted. Select the
channel you want to modify, press the Origin button at the bottom of the
Channel Editor, and follow the prompts at the bottom of the screen.

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This procedure requires that you turn the MODE key switch to the SPECIAL
position and press the START button on the Control Console.

The dummy wire extends fully in the selected channel and the control software
displays a message prompting you to use the IN and OUT buttons in the
DUMMY section of the afterloader keypad to adjust the origin offset.

When you press the IN or OUT button, the dummy wire moves in 0.5 cm
increments. As you adjust the offset, the position is updated in the message
box. The maximum offset for the origin is 40.0 cm.

WARNING 2-3: The control software does not check to see if the adjusted
position of the origin is correct. You must be aware of the
potential risk of a mistake when adjusting the origin and must
carefully check the adjusted position in each channel that you
change. Failure to do so may result in serious injury to the
patient.

When you are finished, press the Save button. The dummy wire retracts fully
and the channel editor indicates the new setting for the distal position.
You can cancel the procedure at any time by pressing the Cancel button.

Delete a Channel

You can delete a selected channel by pressing the Delete button and
confirming the message. Then press the Save button to save the change, close
the Channel Edit Strip, and display the updated channel information in the
Channel View Strip.

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Save or Cancel Changes

Press the Save button to save all of the channel modifications and close the
Channel Edit Strip. The control software displays the updated channel
information in the Channel View Strip.

Note: If you make any changes to dwell positions or dwell times and 2
press the Save button, the control software displays a message
indicating that the dose assigned to the plan may no longer be
correct and that the changes apply only to the current fraction.
The message asks you to confirm that you want to save the
changes.

Press the Cancel button to discard the channel modifications you made since
the last time you pressed the Save button and close the Channel Edit Strip. In
this case, the Channel View Strip is not updated.

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Chapter 3 Delivery of Patient Treatment

This chapter describes how to use the GammaMedplus iX system to deliver a


patient treatment. It is assumed that you are familiar with the information in the
first two chapters of this manual, including how to use the control software to
import a patient treatment file.

The material in this chapter is organized according to a typical HDR treatment


sequence that is outlined in the first section. Each step of this sequence is 3
discussed in further detail in the sections listed in the “In This Chapter” table
below. In addition, this chapter includes a description of how to interrupt a
treatment and how to continue an interrupted treatment.

In This Chapter

Topic Page
Typical HDR Treatment Sequence 3-2
Perform Treatment Day Tests and Checks 3-3
Insert the Applicator 3-4
Determine the Treatment Plan 3-5
Prepare the Patient, Afterloader, and Control Software 3-6
Deliver and Monitor the Treatment 3-13
Complete the Treatment Delivery 3-29
Interrupt a Treatment 3-33
Partial Treatment Strip 3-34

3-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Typical HDR Treatment Sequence


This section outlines a sequence of steps for using the GammaMedplus iX
system to deliver an HDR treatment. Each step is described in further detail in
subsequent sections of this chapter.

Note: This sequence of steps represents one example only. The


treatment protocol at your facility may vary.

1. Perform Treatment Day Tests and Checks


Prior to commencing any patient preparation or patient treatment, perform
appropriate tests and safety checks according to the quality assurance
protocol at your facility. (This step can be done before the patient arrives.)

Important: Patient preparation must not begin until all safety checks and
tests are completed successfully.
2. Insert the Applicator
In accordance with good clinical practice and the relevant applicator
instructions for use, insert the applicator into the patient. Verify the correct
positioning of the applicator.
3. Determine the Treatment Plan
Under the guidance of a physician, with reference to a treatment planning
system, determine the treatment positions and dwell times for each
channel.
4. Prepare the Patient, Afterloader, and Control Software
According to the treatment plan, place the patient in the proper treatment
position with respect to the afterloader, connect the source guide tubes to
the correct channels of the indexer head, and prepare the control software
for treatment delivery. If necessary, secure the applicator and instruct the
patient in treatment procedures.

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5. Deliver and Monitor the Treatment

• Initiate the treatment using the control software.


• Compare the Planned Treatment Report from the control software with
the treatment report from the treatment planning software and perform
any other pre-treatment tests and checks appropriate to your site. This
step is critical to help ensure a proper treatment.
• Prepare the control software and the afterloader for treatment delivery
and begin the treatment.
3
• Using the Channel View Strip and Control Console, monitor the
treatment delivery.

6. Complete the Treatment Delivery

• After completion of the treatment, review the Treatment Delivery


Report. In the event of interruption of treatment, use the Partial
Treatment Strip to complete the treatment.
• Disconnect the source guide tubes from the afterloader and remove the
applicator from the patient. Move the patient from the treatment room.
• If the GammaMedplus iX system is not required for further immediate
use, turn the afterloader keypad key switch to the LOCKED position,
remove the key, and store it in a secure location.

Perform Treatment Day Tests and Checks


Before preparing the patient or beginning daily treatments with the
GammaMedplus iX, you must perform a safety check of the complete system
according to the quality assurance protocol at your facility. A partial checklist
of safety checks you might want to include follows:

• Interruption of treatment using the INTERRUPT button and


EMERGENCY RETURN switch
• Door interlock (and any additional safety interlocks)
• Power and power failure
• Control console and afterloader key tests

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• Room radiation monitor (optional equipment, not Varian supplied)


• Afterloader radiation monitor
• Source guide tube misconnection
• Observation equipment (viewing equipment and intercom)

Refer to the “Treatment Day Tests and Checks” section in Appendix D “Safety
Information and Tests” for more information on each of the safety checks
listed above. The treatment day tests and checks are a part of the overall quality
assurance and safety procedures implemented at your site. Refer to the
“Perform Physics and Service Functions” section in Chapter 4 “System
Configuration” for more information on creating and running physics test
treatments.

Insert the Applicator


The GammaMedplus iX system supports a full range of intracavitary,
intraluminal, and interstitial applicators. Refer to the Varian BrachyTherapy
Applicators and Accessories Catalogue for a complete list of available
applicators and accessories. Each applicator is shipped with detailed
instructions for use, including assembly, insertion, removal, disassembly, and
sterilization of the applicator set. Be sure to read and follow these instructions
carefully.

Note: You must clearly differentiate between applicators with direct


connection to the GammaMedplus iX and those applicators that
require an adapter connection to the source guide tube. Refer to
the applicator instructions for use for more information.

Note: If you are using an asymmetric applicator, such as the Shielded


Applicator Set, the applicator should be checked
radiographically for orientation after insertion.

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Important: All source guide tubes and catheters with clamping adapters or
combinations of source guide tubes and applicators must be
tested for the correct length of 130 cm with the help of a
calibrated measurement instrument. Before every use, these
combinations must be tested unconditionally for being intact. In
addition, pay attention that there are no liquids in the source
guide tubes or applicators.

Note: The GammaMedplus iX afterloader supports up to 24 channels. 3


For channels 1-19, the dummy wire performs a channel end test
to verify that the channel length is the required 130 cm and no
longer. For channels 20-24, the dummy wire does not push
against the end of the channel during the dummy wire test. In
these channels, the dummy wire only checks to see if the
channel length is at least 130 cm, but not whether it is longer
than 130 cm. You must check the correct length of each channel
(source guide tube + applicator) before the treatment using the
appropriate length gauge.

The bronchial catheter is an example of an applicator that


requires the use of channels 20-24. Due to the design of this
applicator, the force of the dummy wire pushing against the
closed end of the catheter during the channel test should be
avoided.

Determine the Treatment Plan


The control software enables you to import, edit, and deliver a treatment
prescription defined in the BrachyVision™ treatment planning system.

The anatomic and geometric location of the applicator and treatment


coordinates are generally determined from digitized x-ray film or CT scan data
and entered into the treatment planning system. The resultant plan establishes
the dwell times and positions for the GammaMedplus iX source. Refer to the
user guide for your treatment planning software for detailed information on
treatment planning.

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WARNING 3-1: The treatment plan must be determined under the guidance
of an experienced physician who has been trained in the
proper use of the GammaMedplus iX system. Failure to do
so may result in serious injury to the patient.

Prepare the Patient, Afterloader, and Control


Software
This section describes the preparatory tasks that must be performed prior to
treatment delivery. Depending on the treatment protocol at your facility, the
tasks may not necessarily be done in the order listed below.
The tasks include:

• Place the patient in the treatment position


• Adjust the height of the GammaMedplus iX afterloader
• Measure and connect the source guide tubes
• Secure the applicator
• Instruct the patient
• Prepare the control software

WARNING 3-2: For safety reasons during preparation, the key switch in the
SOURCE section of the afterloader keypad must be in the
LOCKED (vertical) position.

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Place the Patient in the Treatment Position


Place the GammaMedplus iX in a suitable treatment location a short distance
away from the patient. To move the GammaMedplus iX, release the foot brake
by raising the lever with the tip of your foot. Then push the GammaMedplus iX
into the desired position. Lock the foot brake again by stepping down on the
brake lever.

WARNING 3-3: For maximum stability during movement, the height of the
GammaMedplus iX must be in the lowest position when you
roll it into place.
When moving the device, pay attention to any connecting
cables. The cables must be placed appropriately to prevent
tripping. Do not run over the cables. Coil the cables loosely
near the GammaMedplus iX, but never around the handles.
Failure to follow these steps may result in injury to you or
the patient.

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Adjust the Height of the GammaMedplus iX


Position the indexer head of the GammaMedplus iX at a suitable height for the
treatment. The motorized height adjustment is controlled by pressing the UP
and DOWN buttons in the HEAD section of the afterloader keypad. The
adjustment range is between 90 and 130 cm (35 and 51 inches) from the floor
to the center of the indexer head.

WARNING 3-4: Due to risk of injury to the patient, perform the height
adjustment carefully if the indexer head is situated above
the patient.

Measure and Connect the Source Guide Tubes

Note: Before you connect the source guide tubes to the indexer head,
use the length gauge to check the correct source guide
tube/applicator probe combination length. Refer to the
instructions for use supplied with the source guide tubes and
applicator for detailed information.

Connect each source guide tube or applicator to the correct channel of the
indexer head according to the channel number determined in the treatment
planning software. Using slight pressure, insert the coupling of each source
guide tube into the channel opening of the indexer head until the coupling is
engaged. Ensure that all source guide tubes are fully seated in the indexer head.

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WARNING 3-5: Be careful to connect the correct source guide tube to the
corresponding channel of the indexer according to the
treatment plan. For more information, refer to the source
guide tube instructions. Interchanging source guide tube
connections will lead to incorrect treatment of the patient.

1
2
23 3
22 4
21 5
6
20
7
19 8
18 9
17 10
16 11
15 14 13 12

The source guide tubes must be clean and free of foreign bodies and moisture.
Water vapor, especially on the inside of the tubes, can lead to damage of the
afterloader.

Free passage of the active wire through the source guide tube and applicator
may be impeded if a tube that is kinked, crushed, stretched, or damaged in any
other way is used. Source guide tubes should be inspected prior to use, and if
they show any signs of defects, they should be discarded.

If a particularly tight curve is being treated, it may be desirable to test treat a


similar curve taped down on a table before the patient is brought in and
connected. Friction is the cause of inability to treat very tight curves. To
minimize this, keep source guide tubes as straight as possible. Never apply
lubricant to any part of the system, including marker wires, applicators,
connectors, etc. The minimum achievable radius of curvature is 13 mm in a
ring probe of 26 mm diameter or in a 5F (1.67 mm) bronchial catheter. This is
based upon a fully supported 180 curve at a distance of 120 cm from the
afterloader, with a straight line of approach. In practice, the achievable radius
of curvature will be dependent upon the total friction in the path between the

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drive mechanism and the curve and the type of tissue surrounding the source
guide tube. If a curve constriction is higher than the drive can overcome, an
automatic retraction will occur.

WARNING 3-6: If necessary, adjust the height of the indexer head so that the
source guide tubes between the patient and the afterloader
are not kinked, twisted, or stressed in any way. Failure to do
so may cause the treatment to terminate prematurely.

WARNING 3-7: The channel number for each applicator or source guide tube
as determined in the treatment planning software must be
followed unconditionally. Do not mix up the connections.
Interchanging the source guide tube connections will lead
to incorrect treatment of the patient.

WARNING 3-8: Do not move the position of the GammaMedplus iX if the


source guide tubes are connected. Once the tubes are
connected, the foot brake must remain locked. Failure to
lock the brake may result in serious injury to the patient or
afterloader equipment.

WARNING 3-9: Inspect non-sterile applicator and connection devices for


mechanical integrity and cleanliness. Replace any tubing
that has foreign matter build-up, as this debris could be
drawn into the afterloader by the dummy and active wires.
Do not sterilize applicators, unless otherwise stated in the
instructions for use, as this could cause harm to the
applicators.

Note: Never leave a source guide tube, clamping adapter, or


applicator in a channel that is not used for treatment.

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Source Guide Tube Support (Optional)

In some treatment situations, it can be helpful to use the GammaMedplus iX


source guide tube support in order to prevent kinking and reduce stress on the
source guide tubes. It also reduces strain on the applicator(s) and keeps the
patient more comfortable.

3
1
2
23 3
22 4
21 5
6
20
7
19 8
18 9
17 10
16 11
15 14 13 12

Screw the source guide tube support into the upper opening of the indexer head
and tighten it by using a 22 mm open-end wrench. Position the hinge of the
source guide tube support suitably and guide the source guide tubes through
the support arm.

1
2
23 3
22 4
21 5
6
20
7
19 8
18 9
17 10
16 11
15 14 13 12

WARNING 3-10: For safe operation, the tubes must be positioned without
loops, double windings, or kinks. Failure to do so may cause
the treatment to terminate prematurely.

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Secure the Applicator


Depending on the situation, it may be necessary to fasten the applicator(s) to
the patient or treatment table using special restraints to avoid displacement
during treatment. Refer to the applicator instructions for use for more
information.

WARNING 3-11: Verify that the applicator components are secured to the
patient or to the treatment table to prevent them from
moving or pulling out.

Instruct the Patient


Before beginning the treatment, inform the patient about the safety,
observation, and communication systems at your facility. If necessary, discuss
some communication signals. Instruct the patient to remain still and in a resting
position. Explain staff and patient behavior in case of emergency situations.

Important: Important advice for the patient:


Do not make any movements that might change the position of the
applicator or source guide tubes.
If necessary, contact the treatment staff immediately by intercom
or viewing equipment.

Prepare the Control Software


If necessary, transfer the treatment plan from the treatment planning system
onto a network drive or a USB-based removable storage device. Import the
treatment plan into the control software using the Open Patient File
workflow. Complete all required tasks associated with the Patient Selection
and Fraction View pages. Use the Channel View and Channel Edit strips on the
Treatment Delivery Page to review and, if necessary, edit the channels in the
current fraction. Refer to Chapter 2 “Patient and Treatment Data” for detailed
information on each of these tasks.

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The “Deliver and Monitor the Treatment” section below begins with the
Initiate Treatment button on the Treatment Delivery Page.

Deliver and Monitor the Treatment


This section describes the tasks involved in delivering and monitoring a patient
treatment using the Treatment Delivery Page of the control software. These
tasks include: 3
• Initiate a treatment
• Review the Planned Treatment Report
• Begin the treatment delivery
• Monitor the treatment

Each of these tasks is described below. Refer to the “View and Edit Channel
Data” section in Chapter 2 “Patient and Treatment Data” for an introduction to
the Treatment Delivery Page and detailed information on how to view and edit
channel data using the Channel View and Channel Edit Strips.

Important: Depending on the language used in your license and the


applicable regulations, any or all of the following persons must
be present during the treatment — authorized user, authorized
medical physicist, and radiation safety officer (RSO). Please
consult with your RSO to ensure a thorough understanding of
who must be present during treatment delivery.

WARNING 3-12: Due to risk of unnecessary exposure to radiation during test


treatments with the active wire installed, no one is allowed
in the treatment room. During patient treatments, only the
patient may be in the treatment room.

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Initiate a Treatment
The Treatment Initiation Strip on the Treatment Delivery Page steps you
through the process of initiating a patient treatment. This strip is closed by
default.

Treatment Initiation Strip

Note: The power to the GammaMedplus iX system must be turned on


before you can initiate a treatment. Verify that the security key
in the key switch of the POWER section on the Control
Console is turned to the horizontal position.

When you press the Initiate Treatment button, the control software
automatically renames the Planned dwell time column in the Channel View
Strip to Scaled dwell time and displays the scaled dwell times based on the
decay scale factor. The control software also displays a message to this effect
at the bottom of the screen. The histogram bars in the channel representation
for each channel are updated, if necessary, to reflect these changes. Refer to the
“Scaled Dwell Time” section in Appendix B, “GammaMedplus iX
Calculations” for more information.

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The control software performs checks on the data to verify that the treatment
parameters are within the operational limits of the afterloader and displays the
Planned Treatment Report. The control software ensures that all treatment
preconditions, including safety interlock checks supported by the attached
afterloader, are satisfied prior to allowing treatment delivery to begin. Refer to
the “Safety Interlocks” section in Chapter 1, “Introduction” for more
information. The control software also verifies that the afterloader and control
PC clocks are synchronized to within 15 minutes of each other. If any of these
checks should fail, a message is displayed.
3
Note: There are limitations on the minimum usable dwell times,
specifically when using very small dwell times (<0.4 sec). The
minimum dwell time that can be delivered for any dwell
position will vary depending on the distance between adjacent
positions. If one or more dwell times are less than the minimum
recommended dwell time, the control software displays a
message to this effect after you press the Initiate Treatment
button. The treatment is disallowed until you comply with
minimal dwell times that will allow for correct operation as
outlined in the “Minimum Dwell Time Restrictions” section in
Appendix B “GammaMedplus iX Calculations”.

Note: There are limitations on the maximum usable dwell times — the
maximum time per dwell position is 9999.9, the maximum time
per channel is 9999.9, and the maximum time per fraction is
99,999.9. If the treatment plan exceeds any of these limits, the
control software displays a message to this effect after you press
the Initiate Treatment button. The treatment is disallowed
until all time limits are satisfied.

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Review the Planned Treatment Report


The Planned Treatment Report enables you to compare the data in the
treatment plan report of the treatment planning software with the same data in
the control software.

Important: This review is critical to help ensure a proper treatment.

The report is divided into the following main sections — Patient/ Treatment
Data, Planned/ Actual Comparison, Treatment Details, and Source Data.

In the Patient/Treatment Data section, the Patient Data includes Patient Last
Name, Patient First Name, Patient Identification, Sex, and Patient Birthdate.
The Plan Data includes Fraction, Physician, Treatment Site, Applicator, Plan
File, Plan Author, and Console Entry Date. The Delivery Data includes
Delivery Status and Decay Scale Factor.

The Planned/ Actual Comparison section includes a table comparing the


Planned and Actual values (if available) for Source Strength, Total Time, and
Total Curie seconds (Ci-s)/GBq-s/Total air kerma strength, indicating the
Difference and Percent Difference for each value. The system units for source
strength are designated in the system configuration options.

The Treatment Details include the Channel Length, Dwell Positions (total),
Planned Time, Scaled Time, Delivered Time, Remaining Time, and a table
showing the dwell Positions, Planned dwell times, and Scaled dwell times for
each channel.

The Source Data section includes the Remaining Active Wire Cycles,
Remaining Source Days, Calibration Date, and Wire Serial number.

This report also includes the randomly generated Treatment Code which is
necessary to deliver the treatment. This code is discussed in the next section.
There is space for approval signatures and dates at the bottom of the report.

Press the Print button to print a hard copy of the report and then the Close
button to close the report and return to the Treatment Delivery Page. In the
absence of a printer, you can use the soft copy of the report to review the data
and obtain the Treatment Code.

A suggested partial checklist for comparing the treatment plan report with the
Planned Treatment Report is included below. Follow the verification
procedure for your facility.

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Checklist for pre-treatment review:

• Verify the correct patient name and patient information.


• Verify that the planned and current source strength are correct.
• Verify that the source strength on the treatment plan report matches that
shown on the Planned Treatment Report.
• The planned dwell times should be verified by independent means before
treatment.
• Ensure that in multiple-channel treatments, each source guide tube is 3
connected to the correct channel of the indexer head. It is imperative that
the treatment plan and afterloader match as far as which source guide tube
is which.
• Compare dwell times and dwell positions from the treatment planning
system to those detailed in the Planned Treatment Report.
• Compare the Total Time and Total Curie seconds in the Planned Treatment
Report with those of the treatment planning system and verify that the
Percent Difference is within the predetermined tolerance allowable at your
site.

Begin the Treatment Delivery


The Treatment Delivery Strip opens when you press the Close button on the
Planned Treatment Report. By default, this strip consists of an entry field for
the Treatment Code, the Deliver Treatment button, and a Cancel button.
The Delivery Treatment button is enabled once all safety interlocks are
satisfied and you enter the Treatment Code.

Before you deliver the treatment, perform any remaining pre-treatment checks
required at your facility. A sample checklist follows.

Checklist before beginning the treatment:

• All components of the GammaMedplus iX system are switched on.


• The patient is connected to the GammaMedplus iX and has received all
necessary attention.

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• The patient data has been verified and approved for treatment delivery.
• All persons except the patient have left the treatment room.
• The door to the treatment room is closed.
• The viewing and intercom systems are operational.

If you decide to cancel the treatment delivery for any reason, press the Cancel
button. The control software displays a confirmation message. Once you
confirm the message, the Treatment Delivery Strip closes and the Treatment
Initiation Strip appears. All scaled dwell times revert to planned dwell times.

WARNING 3-13: All persons except the patient must leave the treatment
room. Failure to do so may cause serious injury.

Follow these steps to begin the treatment delivery:

In the treatment delivery room:

1. Insert the SOURCE key into the key switch of the afterloader keypad (if
necessary) and turn the key from the LOCKED to the RELEASED
(horizontal) position. The RELEASED indicator light turns on.

LOCKED

2. Verify that there is no one in the treatment room except the patient. Press
the Last Man Out button (if installed), exit the treatment room, and close
the treatment room door.

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In the control room:

1. Verify that the POWER key is inserted in the Control Console and turned
to the MAINS (horizontal) position with the MAINS indicator light on.
(This step must be completed earlier, before treatment initiation can
begin.)
2. Verify that the MODE key is inserted in the Control Console and turned
to the NORMAL (vertical) position with the NORMAL indicator light
on.
3. Enter the 5-digit Treatment Code into the Treatment Code field of the
3
Treatment Delivery Strip. This code is located at the bottom of the Planned
Treatment Report.
4. Press the Deliver Treatment button. The STARTED indicator light on
the Control Console flashes and an audible signal is generated.

Note: Once you press the Deliver Treatment button, the control
software is locked against further input, and the Log Out and
Secure System buttons are disabled.

Note: All data for the channels in the current fraction are sent to the
GammaMedplus iX afterloader when you press the Deliver
Treatment button. There is a steady exchange of data during
the treatment delivery process.

5. Press the START button in the TREATMENT section of the Control


Console. The STARTED indicator changes from a flashing to a
continuous light and the audible signal turns off.

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Monitor the Treatment


The Treatment Delivery Page enables you to closely monitor the treatment
delivery. During the treatment, this page displays real-time graphical
representations of the dummy and active wires along with dynamically
updated values for a number of parameters, including the wire type (active or
dummy), the wire status, the dwell point and position, the total current dwell
time, and the total remaining treatment time for the current fraction.

Channel View Strip

Treatment Delivery Strip

The treatment status and alarm indicators on the Control Console, afterloader
keypad, and other remote consoles provide constant feedback on the status of
the treatment. In the event of an afterloader error condition, the control
software displays a dialog box containing the error code and class, error
description, suggested actions, and optional site-specific notes at the bottom of
the screen. Refer to the “Status and Error Messages” section below for more
information on errors and error conditions. Refer to the “Interrupt a Treatment”
section for information on how to interrupt a treatment.

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Dummy Wire and Active Wire Movement

The movement of the dummy and active wires is displayed in two locations on
the Treatment Delivery Page — in the graphical representation of each channel
in the Channel View Strip and in the graphical representation of the Wire
position in the Treatment Delivery Strip. The Wire position representation is
displayed after you press the Treatment Delivery button. In both locations,
the movement of the dummy wire is displayed in green, and the active wire is
displayed in yellow.

The Wire position graphical display is an at-a-glance indication of the wire 3


position as the wire moves through the length of the entire channel. The actual
Wire position in centimeters updates in real-time in the middle of the
graphical representation. The current dwell position is indicated by the end of
the yellow bar. Vertical lines in the channel representation indicate the most
distal and proximal dwell positions.
Distal dwell position

Proximal dwell position


Current dwell position

When the dummy or active wire has reached the most proximal dwell position
in the Wire position graphical display, the movement of the wire is also
displayed in the Channel View Strip. If all of the dwell positions for a
particular channel are not visible in the Channel View Strip at once, the display
of the channel shifts to the left or right in the Channel View as necessary to
indicate the current wire position.

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When the active source is dwelling at a given position, the dwell point
histogram indicator (bar) in the channel representation of the Channel View
Strip incrementally fills with yellow to graphically indicate the remaining
dwell time. The dwell positions for channels that have been treated are black
in color. Untreated positions are blue in color. Refer to “The Channel View
Strip” section in Chapter 2, “Patient and Treatment Data” for more information
on this strip.

Dummy Wire Sequence and Tests

When you begin the treatment delivery, an Initial dummy wire test may be
performed in all programmed channels, depending on the setting for the
Dummy wire sequence in the system configuration options.
There are two options for the Dummy wire sequence:

• Dummy all/ Dummy each/ Active each —sends the dummy wire out on
all programmed channels, and then alternates between the dummy wire
and active wire for each programmed channel
• Dummy each/ Active each — alternates sending the dummy wire and
then the active wire out on each programmed channel

Note: If you have selected the first option, and an error is encountered
in a particular channel during the dummy wire test on all
channels, you must fix the problem and press the START
button to resume the dummy test. The test resumes with the first
used channel in the treatment plan and tests each channel used
in sequence. If multiple errors are encountered, the dummy test
always resumes with the first used channel and tests each used
channel in sequence.

The dummy wire checks for an applicator or catheter connection, an


unobstructed path, and the correct length (130 cm) of the source guide tube and
applicator assembly.

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Note: The GammaMedplus iX afterloader supports up to 24 channels.


For channels 1-19, the dummy wire performs a channel end test
to verify that the channel length is the required 130 cm and no
longer. For channels 20-24, the dummy wire only checks to see
if the channel length is at least 130 cm, but not whether it is
longer than 130 cm. You must check the correct length of each
channel (source guide tube + applicator) before the treatment
using the appropriate length gauge.

If the dummy wire test is successful, the source wire extends in the channel to 3
deliver the treatment. If the dummy wire test fails, you must clear the cause of
the error and resume the treatment using the Partial Treatment Strip, described
in the “Partial Treatment Strip” section included later in this chapter.

Refer to the “Specify the Dummy Wire Sequence” section in Chapter 4


“System Configuration” for information on how to verify or change the
Dummy wire sequence option.

Source Wire Extension

After a successful dummy wire test on a given channel, the active source
extends in that channel and at the same time a short warning tone can be heard.
In addition, the radiation monitor warning light in the treatment room
illuminates. In the control software, the radiation symbol flashes in the
Treatment Delivery Strip. The Wire field in the Treatment Delivery Strip
indicates Active and the Status field indicates Extending, Dwelling, or
Retracting. Refer to the “Dwell Time, Dwell Position, and Wire Status
Information” section below for more information on the indicators at the
bottom of the Channel View Strip.
On the Control Console, the SAFE indicator light in the SOURCE section
extinguishes, and the yellow OUT indicator light illuminates.

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Note: The OUT light indicates the extension of the active wire from
its shielded position. This light is activated via mechanical
contacts. The yellow radioactive symbol also indicates an
unshielded source, but for safety reasons, it is activated when
the Geiger-Müller system detects radiation.

WARNING 3-14: If either of the yellow indicators — the OUT light or the
RADIATION symbol — in the SOURCE section of the
Control Console does not light during source extension, a
hazardous failure condition may exist. Interrupt the
treatment immediately by pressing the INTERRUPT
button or the EMERGENCY RETURN switch. Determine
the cause of the failure and eliminate the problem before
resuming treatment. Failure to do so may cause injury to the
patient.

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Note: The active wire display in the control software is an estimate of


where the active wire is until it reaches the first dwell position.
When dwelling on a position and at the end points, the active
wire display accurately represents the actual wire position. The
dwell time and dwell position information in the Treatment
Delivery Strip gives the correct status of the actual wire at all
times.

Note: If a deviation of more than 1.4 seconds from the scaled dwell 3
time occurs, the treatment is interrupted and the Partial
Treatment Options are displayed.

The treatment delivery continues as follows:

• For each channel, a dummy wire test is automatically executed and the
operator is signaled if any obstructions or other errors are encountered.
• If the wire test is successful, the afterloader automatically treats each
channel with the active source wire.
• This process is repeated until:

• All programmed channels have been treated, or


• An error condition occurs, or
• The treatment is interrupted by pressing the INTERRUPT button,
EMERGENCY RETURN switch, or EMERGENCY button.

Dwell Time, Dwell Position, and Wire Status Information


As the treatment delivery progresses, the Treatment Delivery Page continues
to update the read-only data in the Channel View table, at the bottom of the
Channel View Strip, and on the Treatment Delivery Strip.

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The Channel View table displays the following information for each channel
in the current fraction:

• Channel name — the name of the channel, if any, as specified in the


Channel Edit Strip
• Current dwell time — a counter that indicates the dwell time elapsed for
the current channel
• Scaled dwell time — the calculated dwell time for the current channel
based on the current source strength
• Channel number — consists of a two-digit number representing the
channel number
• Graphical representation of each channel — displays the dwell position
for the first dwell point, the last dwell point, and histogram bars for each
dwell point within the channel, where the height of the bar indicates the
total scaled dwell time at that position
• Catheter length (cm) — fixed at 130 cm for the GammaMedplus iX
• Dwell positions — the total number of dwell positions for the channel

The bottom of the Channel View Strip includes the following read-only fields:

• Remaining treatment time (min:s) — the value of this dwell time


"count-down" timer starts as the sum of all planned dwell times, and
decrements during the treatment as each dwell position is delivered
• Current dwell time (total) — the sum of all of the dwell times delivered
for the current fraction
• Scaled dwell time (total) — the sum of all scaled dwell times for the
current fraction
• Dwell positions — the total number of dwell positions in the current
fraction

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The Treatment Delivery Strip displays the following read-only fields:

• Wire — indicates whether the Active or Dummy wire is extended


• Status — indicates Parked, Extending, Dwelling, or Retracting for the
active wire and Parked, Extending, or Retracting for the dummy wire
• Point — the number of the dwell position currently being treated (with
number 1 being the most distal dwell position)
• Position — displays a graphical representation of the wire position (in cm)
as the wire moves through the length of the channel currently being treated 3

Note: The Radiation symbol flashes in the Status Strip when the
active wire is extending, dwelling, and retracting.

When the treatment is completed, the Treatment Delivery Report is available.


After you print or close the report, the Patient Selection Page appears. Refer to
the next section, “Complete the Treatment Delivery” for information on the
Treatment Delivery Report.

Status and Error Messages

The control software displays status and error messages at the bottom of the
screen, above the System Status Strip. The following message types are
supported:

• Directives — Displayed when the user needs to perform a task, like “Press
the START button”.
• Status (or information) messages — Displayed for information only, like
“Downloading plan to the afterloader...please wait.”. No interaction is
required by the user.
• Interrupt messages — Displayed when a treatment is interrupted by the
afterloader or the user. Usually, the treatment can be continued by pressing
the START button on the Control Console.
• Emergency messages — Displayed when a treatment cannot be
continued. The treatment can be continued using the Partial Treatment
Strip (refer to the “Partial Treatment Strip” section below).

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Directives are usually displayed with a green background, and status messages
are displayed with a beige background. Interrupt and emergency messages are
displayed with a red background. In the event of simultaneous error conditions,
the most severe error is displayed.

Interrupt and emergency messages are initially displayed with the error text
and one or two buttons — View Detail and Clear Error.

Press the View Detail button to see an additional dialog box containing the
error description, error code and class, any possible actions you might take, and
any notes that the administrator has entered using the annotate message feature
of the system configuration options. Refer to the “Annotate Error Messages”
section in Chapter 4 “System Configuration” for more information on how to
customize your error messages.

After you view the message details, press the Done button to return to the
original error dialog box.

All afterloader errors are written to an error log. Other loggable events, such as
user log on, log off, treatment initiation, and wire exchanges are written to the
event log. You can use the Error Log tab in the Console & Afterloader Strip
in the system configuration options to view and print these logs. Refer to the
“Review Error and Event Logs” section in Chapter 4 “System Configuration”
for more information.

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Note: In addition to the error message box, an audible alarm is


generated for any error that occurs while the active wire is
extended or if a communication error is detected during
treatment. Errors that occur during treatment are recorded in the
Treatment Delivery Report, Treatment History Report, and
Fraction Report.

Complete the Treatment Delivery


3
Treatment completion consists of reviewing the treatment results, looking after
the patient, and securing the afterloader. After delivering the treatment to all
programmed channels in the current fraction, the source is automatically
retracted into the shielded position and the green SAFE indicator light in the
SOURCE section of the Control Console illuminates. At the same time, an
audible signal can be heard, and the green COMPLETED indicator in the
TREATMENT section of the Control Console illuminates. The
RADIATION indicators on the Control Console and afterloader keypad turn
off.

TED

Important: Before entering the treatment room, verify that the room
radiation warning light is off, the RADIATION symbols on the
Control Console and afterloader keypad are off, and the
SOURCE SAFE indicator light is on.

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Review Treatment Results


The Treatment Delivery Report enables you to review and print a hard copy of
the data for the treatment delivery. The report is divided into the following
main sections — Patient/ Treatment Data, Planned/ Actual Comparison,
Treatment Details, and Source Data.

In the Patient/Treatment Data section, the Patient Data includes Patient Last
Name, Patient First Name, Patient Identification, Sex, and Patient Birthdate.
The Plan Data includes Fraction, Physician, Treatment Site, Applicator, Plan
File, Plan Author, and Console Entry Date. The Delivery Data includes
Delivery Status, Decay Scale Factor, Operator, Delivery Date, Start Time, and
End Time.
The Planned/ Actual Comparison section includes a table comparing the
Planned and Actual values (if available) for Source Strength, Total Time, and
Total Curie seconds (Ci-s)/GBq-s/Total air kerma strength, indicating the
Difference and Percent Difference for each value. The system units for source
strength are designated in the system configuration options.

The Treatment Details include the Channel Length, Dwell Positions (total),
Planned Time, Scaled Time, Delivered Time, Remaining Time, and a table
showing the dwell Positions, Planned dwell times, Scaled dwell times, and
Delivered dwell times for each channel.

The Source Data section includes the Remaining Active Wire Cycles,
Remaining Source Days, Calibration Date, and Wire Serial number.

If the treatment was interrupted for any reason, an additional Interruption Data
section is included at the end of the report. This section includes Time of
Interruption, Error Class, Error Code, Error Description, Channel, Dwell
Location, Time Spent at Dwell, and Continuation Option.

There is a space for an approval signature and date at the bottom of the report.
Press the Print button to print a hard copy of the report or the Close button to
close the report and return to the Patient Selection Page.

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Update ARIA Appointments Database (optional)


If the patient treatment file was imported from an ARIA database and the
Enable ARIA integration and Enable appointment integration options are
activated in System Configuration, the control software automatically updates
the treatment status in the ARIA database upon completion of the first fraction.

For each subsequent fraction, upon completion of the fraction, the control
software displays a message that asks you if you would like to search for the
appointment that corresponds to the current fraction. If you respond
affirmatively, the control software displays a list of the appointments 3
scheduled for the patient on the day the fraction was completed in an
Appointments table. Select the relevant record in the table and press the OK
button to update the treatment status in the ARIA database.

Note: If the relevant appointment does not display in the appointments


table or for some reason the control software cannot update the
status of the appointment, you must update the status manually
in the ARIA database.

Look After the Patient


When the treatment is completed, attend to the medical needs of the patient.
Disconnect the source guide tubes from the GammaMedplus iX and from the
applicator. Remove the applicator from the patient and move the patient from
the treatment room.

1
2
23 3
22 4
21 5
6
20
7
19 8
18 9
17 10
16 11
15 14 13 12

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WARNING 3-15: In order to assure safety, place the indexer head in the lowest
position before moving the GammaMedplus iX.

Collect all source guide tubes and applicators and place them in a suitable
container for cleaning and sterilization.

Note: Refer to the applicator instructions for use for further


information on cleaning and sterilizing the applicator.

Secure the Afterloader


After completion of a patient treatment, log out of the control software window
by pressing the Log Out button. Close the control software by pressing the
Shut Down button on the Start Page.

Switch the POWER key to the OFF (vertical) position on the Control Console
and remove the key.

Switch the SOURCE key on the afterloader keypad to the LOCKED (vertical)
position and remove the key.

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3
For normal storage (after treatment), the battery key stays in ON position to
secure the source and charge the battery. If you need to move the afterloader to
another room, keep the battery key switch in the ON position. For longer
distances (e.g., using an elevator), local regulations must be taken in
consideration. For information on transporting the GammaMedplus iX, refer
to Appendix E, “Transporting the GammaMedplus iX”.

WARNING 3-16: The GammaMedplus iX must be secured against


unauthorized use by removing all keys every time the
responsible operating personnel leave the area. The keys
must be stored in a secure location.

Interrupt a Treatment
You may need to interrupt a treatment in an emergency or in the absence of an
emergency situation, for example, in order to change the position of the patient.
Press the INTERRUPT button on the Control Console.

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Note: Pressing the INTERRUPT button causes the source to retract


at normal speed.

The source is retracted, and the treatment program is interrupted. The


INTERRUPTED and SAFE indicators on the Control Console turn green,
and the RADIATION symbol and RADIATION warning lights turn off. An
audible signal is generated.

WARNING 3-17: The accurate achievement of the prescribed dose may be


endangered if many transits of the source from and to the
afterloader are carried out during a treatment, for example,
through manual interrupts.

You can usually continue an interrupted treatment by pressing the START


button on the Control Console. Refer to Chapter 5, “Emergency Procedures”
for detailed information on interrupting a treatment during an emergency.

Partial Treatment Strip


The Partial Treatment Strip appears automatically when a treatment cannot be
continued and displays options for how to proceed with the undelivered portion
of the treatment.

The available options function as follows:

• Abort this fraction — aborts the current fraction. Undelivered dwell


positions will not be carried forward to subsequent fractions.

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• Abort this fraction, but distribute the undelivered portion over all
remaining fractions — determines how much of the current fraction
could not be delivered and distributes this amount equally over the
remaining fractions. This option is only available if each of the remaining
fractions is identical to the current fraction. This option is disabled if there
are no remaining fractions when the treatment is interrupted, or if at least
one subsequent fraction does not match the current one.

Important: The option above may have dose and radiobiological effects on 3
the remaining fractions and should only be chosen after careful
consideration of these changes.

• Abort this fraction, but create a new fraction consisting of the


undelivered portion of this fraction — makes the undelivered portion of
the treatment the next fraction and inserts this fraction in the Fraction View
Table on the Fraction View Page

Once you choose an option and press the Proceed button, the control software
generates a Treatment Delivery Report that includes an Interruption Data
section. Refer to the “Review Treatment Results” section above for more
information on the Treatment Delivery Report.

If you choose to continue the treatment at a later session, the control software
displays the Patient Selection Page after you close the Treatment Delivery
Report.

If you interrupt a treatment using the EMERGENCY button on the afterloader


keypad, you need to reset the power on the Control Console. Refer to the
“Restart After Pressing the EMERGENCY RETURN Switch” section in
Chapter 5, “Emergency Procedures” for information on this procedure.

Note: The Log Out button is disabled when the Partial Treatment
Strip is open.

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Continue Treatment after Afterloader Power Failure


The GammaMedplus iX system is designed to retract the active wire
automatically when Control Console communications are lost in the event of a
power failure. The GammaMedplus iX afterloader maintains the treatment
data for all delivered dwell positions for the current fraction in its
battery-backed SRAM storage. This information is only present in the SRAM
while conducting a treatment delivery. Once a treatment is completed, the data
is cleared.

If a treatment interruption occurs because of, or in conjunction with, a power


failure, the control software retrieves the data stored up to the time of
interruption directly from the afterloader upon restarting the
GammaMedplus iX system. If an afterloader power failure should occur
during treatment, restart the afterloader and press the ALARM RESET
button. Then use the Partial Treatment Strip in the control software to
determine how to continue the treatment.

The stored data is displayed in an Interruption Data section at the end of the
Treatment Delivery Report. This section includes Time of Interruption, Error
Class, Error Code, Error Description, Channel number, Dwell Location, Time
Spent at Dwell, and Continuation Option. Refer to the “Review Treatment
Results” section above for more information on the Treatment Delivery
Report.

Continue Treatment after Control Software Failure


In the event that the control software fails during treatment, restart the control
PC and press the ALARM RESET button. The control software displays an
error message.

When you press the Clear Error button in the message box, the following
startup message is displayed:
The last patient treatment was interrupted. Log on to the “Open Patient File”
workflow to select a treatment continuation option.

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After you log onto the Open Patient File workflow, the Treatment Recovery
Report is displayed, followed by the Partial Treatment Strip. After you choose
a partial treatment option, the Treatment Delivery Report will be generated
documenting the current status of the treatment. Refer to “Review Treatment
Results” section in this chapter for more information on the Treatment
Delivery Report.

The Treatment Recovery Report is divided into the following main sections —
Patient/ Treatment Data and Recovery Data. The Patient Data section includes
Patient Last Name, Patient First Name, Patient Identification, Sex, and Patient
Birthdate. The Plan Data includes Fraction, Physician, Treatment Site,
3
Applicator, Plan File, Plan Author, and Console Entry Date.

The Recovery Data portion of the report includes Start time, Channel number,
Active Wire Position, Time Spent at Dwell, Time Remaining at Dwell, and
Time Spent on Patient.

Note: You cannot deliver a treatment of any kind (patient or test) until
you have selected a partial treatment option.

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Chapter 4 System Configuration

The control software provides a variety of options that help you configure the
GammaMedplus iX system to meet the needs of your facility. These system
configuration options enable a user with appropriate access privileges to set up
new user accounts, set system preferences, and perform maintenance and other
routine functions. The options also support Varian service personnel in such
tasks as problem diagnosis and wire replacement.

The system configuration options are available on the System Configuration


Page. The three configuration strips on this page consist of a series of tabs, with
each tab representing a configuration task, such as Folder Setup. The
4
configuration strips are as follows:

• User & Location — enables you to configure user accounts, group access
privileges, afterloader location data, file location data, and owner
information
• Console & Afterloader — enables you to view the system status, view
error and event logs, annotate error messages, define standard plans,
specify applicator definitions, specify locations for and perform backup
and restore operations, and configure system settings
• Source & Wire — enables the appropriate user to set up and administer
physics test plans, view and edit information regarding the source strength,
and view source and dummy wire information. Service engineers may
specify data about source and dummy wire installations and specify
service engineer parameters.

In This Chapter

Topic Page
Access the System Configuration Page 4-2
Define User Access and Location Information 4-3
Set Up the Console and Afterloader 4-16
Perform Physics and Service Functions 4-38

4-1
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Access the System Configuration Page


The System Configuration Page appears when you press the System
Configuration button on the Start Page and log into the control software. By
default, the User Info, User & Location, and System Status Strips are open, and
the Console & Afterloader and Source & Wire Strips are closed.

User Info Strip

User & Location Strip

Console & Afterloader Strip


Source & Wire Strip

System Status Strip

The User Info Strip provides read-only data about who is currently logged into
the control software, including the Operator and Location. It also provides
buttons for securing or logging out of the system. Refer to the “Open Patient
File Workflow” section in Chapter 2 for more information on the Secure
System button and to the “System Status Strip” section in Chapter 1 for
information on the System Status Strip.
The User & Location, Console & Afterloader, and Source & Wire Strips are
described in detail below.

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Save or Cancel Changes

The Save and Cancel buttons work the same way throughout the System
Configuration Page.

The Save button enables you to save your changes.

The Cancel button discards all entries made since opening the current tab. A
confirmation message is displayed before the entries are discarded.

Note: Once you make a change in any tab, you must press the Save or
Cancel button before you can select another tab in the current
strip. 4

Define User Access and Location Information


The User & Location Strip is opened by default when you access the System
Configuration Page. This strip enables you to configure user accounts, group
access privileges, afterloader location data, file location data, and owner
information.

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This strip consists of the following tabs:

• Users — create new user accounts, or modify or delete existing ones.


• Groups — create new access groups and define the user privileges
associated with each group
• Locations — specify contact information for one or more physical
locations where the GammaMedplus iX system is used
• Folder Setup — specify folder locations for patient treatment plans,
treatment plan exports, error log exports, system backup, and report and
diagnostic file exports
• Owner Information — store information about the owner of the
GammaMedplus iX system

If another strip is currently open, press the User & Location button to open the
User & Location Strip.

Define Users
The control software supports controlled access to all product features through
user and group assignments and mandatory passwords for all users. The Users
tab enables you to create new user accounts or modify or delete existing ones.
This tab consists of a sortable table, with each row corresponding to a user
login account, and a set of buttons for maintaining user accounts.

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View and Select Users

The user table contains the following fields:

• User — the current list of user login IDs


• Group — the group to which a user is assigned
• Location — the treatment location for which the login ID is valid
• Password — the user password
• Password expires (days) — the user password time limit in days

Note: The user, group, location, and password fields are required for 4
each record.

You can click on a record to select and highlight it in the table. Click on the
header of a field to sort the records in ascending or descending order using the
values in the selected field.

Add a New User

The Add button at the bottom of the Users tab enables you to add a new user
to the user table. When you press this button, an empty record appears at the
bottom of the table. Enter the new user login ID in the User field. Each login
ID must be unique for a specific location. Login IDs are not case sensitive.

Press the Enter key or click on the drop-down arrow in the Group field and
select the group to which you want to assign the new user.

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By default, there are four types of users defined in the control software based
on the functions they perform and an additional option for specifying Inactive
users:

• Administrator — defines new users and groups, assigns passwords,


configures customer and treatment location information, defines custom
error messages, and performs general setup of the computer system
• Oncologist — determines prescription dose and approves the treatment
plan
• Physicist — performs functions involved in machine calibration and
quality assurance
• Radiation therapist — performs all functions related to treatment
delivery
• Inactive — a flag that enables the administrator to temporarily deny
system access to a user without deleting any of the currently stored
information about the user

Note: There must always be at least one user assigned to the


Administrator group.

Note: In addition to the four user groups specified above, there is also
a Service engineer account for providing routine maintenance
and service functions on the GammaMedplus iX system. For
safety reasons, access to and set up of this account is restricted
to Varian service engineers.

Refer to the next section, “Specify Access Privileges for Groups” for
information on how to set group privileges and create a new group.
Click on the drop-down arrow in the Location field and select the treatment
location. Enter a password in the Password field. Passwords must be at least 4
characters and no more than 15 characters in length, with no spaces. Passwords
are not case sensitive.

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Note: When you create a new user account, the initial value you enter
in the Password field is visible until you press the Save button.
Following that, the Password field displays only asterisks.
Users with Administrator or Service engineer group
privileges can reinitialize a user's password as needed using this
field.

Press Enter or click on the Password expires field and enter the time limit in
days for the user password. After the time limit expires, the user is required to
enter a new password. Set the expiration to 0 for a password that never expires.
The maximum time limit is 365 days.

4
Delete a User

The Delete button at the bottom of the Users tab enables you to delete the
selected record from the user table. When you press the Save button, the user
is removed from the control software database.

Specify Access Privileges for Groups


The Groups tab enables you to create new access groups and define the user
privileges associated with each group. This tab consists of a group name field,
a sortable table with each row corresponding to a user privilege, a combo box
for selecting the current group, and a set of buttons for maintaining group
privileges.

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Select a Group

By default, four system groups and associated privileges are defined —


Administrator, Oncologist, Physicist, and Radiation therapist. Refer to the
“Add a New User” section above for a description of each group.

Click on the Group button at the bottom of the tab to display the current list of
groups. Click on a group name to select it.

The selected group appears in the Group name field and the check boxes in
the Allowed field for each record are updated to reflect the privilege
assignments for that group.

View and Assign Group Privileges

The privileges table contains the following fields:

• Privilege — descriptions of the privileges


• Allowed — check boxes for enabling or disabling a privilege

You can click on an option to select and highlight it in the table. Click on the
Allowed check box to enable or disable the corresponding privilege. Click on
the header of the Privilege field to sort the privileges in ascending or
descending order.

Add a New Group

You can create a new group and assign privileges to it. Press the Add button
and enter a unique name in the Group name field.

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Use the Allowed check box for each privilege to enable or disable the
privileges for the new group. Press the Save button to save your changes. The
name of the group appears in the Group drop-down list at the bottom of the
tab. There is no limit on the number of access groups.

Note: You cannot edit privileges or add new privileges to the list.

Delete a Group
The Delete button enables you to delete the selected group. The control
software displays a confirmation message before the deletion occurs.
4

Note: The control software ensures that there is always at least one
group assigned the right to define users and groups. You cannot
delete any of the default system groups — Administrator,
Oncologist, Physicist, or Radiation therapist.

Copy a Group

The Copy button enables you to copy the selected group. Enter a unique name
for the new group in the Group name field. Make any necessary changes to
privileges and press the Save button. The new name appears in the Group
drop-down list.

Reset Group Privileges


You can use the Default button to reset the privilege assignments to the default
values for the system groups — Administer, Oncologist, Physicist and
Radiation therapist. Select one of these groups and click the Default button to
reset the privileges. A confirmation message is displayed before the privileges
are reset. Press the Save button to save your changes.

Note: You cannot use the Default button to reset privilege


assignments for non-system groups, i.e., groups you have
created.

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Specify Location Information


The Locations tab enables you to specify contact information for one or more
physical locations where the GammaMedplus iX system is used. This tab
consists of a sortable table with each row representing a location, edit fields for
the location address and any additional notes, and a set of buttons for
maintaining the location information.

Note: For non-transportable systems, you can only specify one


location, whereas for transportable systems, you can specify
multiple locations. For this reason, the Add and Delete buttons
are only available for transportable systems.

Note: The default location is “Clinic”.

Add a New Location

The Add button at the bottom of the Locations tab enables you to add a new
location to the table. When you press this button, an empty record appears at
the bottom of the table. Enter the name for the location in the Location field.
Each location name must be unique. To add information to the other fields in
the table or to the Location address or Location notes fields, click on the field
and enter the relevant information.

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The locations table contains the following fields:

• Location — the name of the location


• Contact name — the name of the contact person for the location
• Contact phone — the phone number for the contact person

You can click on a record to select and highlight it in the table. The Location
address and Location notes fields will automatically display the data for the
selected location. Click on the header of a field to sort the records in ascending
or descending order using the values in the selected field.

4
Edit Location Information

You can modify an existing location by clicking on the field you want to edit
in the location table and entering the updated information. You can update the
Location address or Location notes by clicking on these fields and entering
new information.

Note: If you change the location name, all users associated with that
location are updated to the new location name.

Delete a Location

The Delete button enables you to delete the selected location. The control
software displays a confirmation message before the deletion occurs.

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Set Up File Folders


The Folder Setup tab enables you to specify folder locations for patient
treatment plans, treatment plan exports, error log exports, system backup files,
report file exports, and diagnostic file exports. This tab consists of a sortable
table, with each row corresponding to a folder location, and a set of buttons for
maintaining these locations.

View and Select a Folder Location

The folder location table contains the following fields:

• File type — the type of file that will be located in the folder
• Alias — the name you want to use to represent the folder location in the
user interface
• Folder — the full path and directory listing for the folder location, such as
G:\Import files (must be a valid location)

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You can define locations for the following types of files:

• Patient treatment plans — the location where you store the treatment
files you want to import into the control software. The alias for this
location appears when you press the File Location button in the Plan
Import Wizard Strip on the Patient Selection Page. Refer to the “Select or
Import a Treatment File” section of Chapter 2 for more information.
• Treatment plan export — the location where you store exported
treatment files. The alias for this location appears when you press the
Export Location button in the Treatment Record Maintenance Strip on
the Patient Selection Page. Refer to the “Select or Import a Treatment File”
section of Chapter 2 for more information.
4
• Error log export — the location for exported error logs. The alias for this
location appears when you press the Select Log button on the Error Log
tab of the Console & Afterloader Strip on the System Configuration Page.
Refer to the “Review Error and Event Logs” section below for more
information.
• System backup — the location where you store backup files or files you
might want to restore. The alias for this location appears when you press
any of the File Location buttons on the Backup & Restore tab of the
Console & Afterloader Strip on the System Configuration Page. Refer to
the “Back Up and Restore Files” section below for more information.
• Report file export — the location for reports saved in PDF format. The
alias for this location appears when you press the File Location button in
the Save to File area on any Report Page. Refer to the “View and Print
Reports” section in Chapter 2 “Patient and Treatment Data” for more
information.
• Diagnostic file export — the location for exported diagnostic files. The
alias for this location appears when you press the File location button in
the Export diagnostic files area on the Backup & Restore tab of the
Console & Afterloader Strip on the System Configuration Page. Refer to
the “Back Up and Restore Files” section below for more information.

You can click on a record to select and highlight it in the table. Click on the
header of a field to sort the records in ascending or descending order using the
values in the selected field.

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Add a New Folder Location

The Add button at the bottom of the Folder Setup tab enables you to add a
new folder location to the table. When you press this button, an empty record
appears at the bottom of the table. Select the type of file that will be located in
the folder from the drop-down list in the File type column:

Click on the Alias field to select it and enter the name you want the control
software to use as an alias for this location. For example, you can enter “Import
treatment files” as the alias for the location where you store the patient
treatment plans you want to import into the control software.

Press Enter or click on the Folder field and enter the location for the folder
including the full path and all directories. The path must begin with a drive
letter and colon or two backslashes. Use a valid folder on a network drive or
removable media.

Note: If you export or save a file to the local hard drive (e.g., C:\), only
a service engineer can retrieve it via the Windows operating
system. It is strongly recommended that you use a valid network
drive or removable media for folder locations.

Note: The File type, Alias, and Folder fields are required for each
record.

Edit a Folder Location

Click on the field you want to modify and enter or choose the new information.

Delete a Folder Location

The Delete button at the bottom of the Folder Setup tab enables you to delete
the selected record from the table.

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View and Edit Owner Information


The Owner Information tab enables you to specify information about the
owner of the GammaMedplus iX system. There can only be one owner per
system. This tab consists of edit boxes for specifying the machine serial
number, owner information, contact information, and a set of buttons for
maintaining this information.

Add or Edit Owner Information

Click on the field you want to modify and enter the new information.

Note: Only users with service engineers privileges may change the
Machine serial number.

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Set Up the Console and Afterloader


The Console & Afterloader Strip enables you to configure or view various
settings for the control PC (Console) and GammaMedplus iX afterloader, such
as error logs and system settings. Click on the Console & Afterloader button
on the System Configuration Page to open this strip.

This strip consists of the following tabs:

• System Status — enables you to view and print read-only data about the
control PC and afterloader
• Error Log — enables you to view, filter, and print the various errors and
events logged on the GammaMedplus iX system
• Annotate Messages — enables you to add site-specific annotations to
standard afterloader error messages
• Standard Plans — enables you to define, edit, and delete standard plans.
Standard plans are collections of channel and dwell information that can
be applied to patient treatment plans.
• Applicator Definitions — enables you to define, edit, and delete
applicator definitions from the control software database
• Backup & Restore — enables you to define the frequency with which
system data files are backed up and the destination backup drive. You can
also specify parameters for restoring files and restore the backed up files.

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• System Settings — enables you to configure and/or view an assortment of


system parameters, including the system date and time, the selected
printer, measurement units for source strength, idle system and secured
system time-outs, the dummy wire sequence, and ARIA communication
settings

Check the System Status


The System Status tab enables you to view and print read-only data about the
control PC and afterloader, such as the current software version and the
number of remaining wire cycles for the active and dummy wires. This tab
consists of a table and a Print button. 4

View System Data

The system status table contains the following fields:

• Status item — a list of each status item, grouped by topics: Login status,
General console data, General afterloader data, Current error data, Source
data, Active wire data, and Dummy wire data
• Current value — the value for the status item. The values are derived
from different sources, presenting an up-to-the-minute snapshot of the
current system status.

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Print the System Status Report

The Print button at the bottom of the System Status tab enables you to view
and print the System Status Report.

Press the Print button to print a hard copy of the System Status Report and the
Close button to close the report and return to the System Status tab.

Review Error and Event Logs


The control software logs all error conditions originating on the afterloader and
any event originating on the control PC that could be used for later problem
diagnosis. The Error Log tab enables you to view, filter, and print the logged
errors and events.

This tab consists of a sortable table, with each row corresponding to a logged
error or event, a set of controls for filtering the records in the table, and a set of
buttons for exporting and printing the logs.

Note: The log containing errors and events is automatically archived


to a text file each time the source wire is exchanged. Once the
log is archived, the current contents of the Error Log tab are
purged.

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Select a Log to View

There are three different ways to view the logged errors and events:

• Error log — lists all errors originating on the afterloader


• Event log — lists events originating on the control PC that can be used for
audit purposes and problem diagnosis
• All logs — consists of both the error and event logs (default)

Refer to Appendix A “System Errors and Messages” for a complete list of error
messages.
4
Click on the Select Log button at the bottom of the tab to display the options
for the types of logs. Click on a log name to select it.

The selected log name appears above the log table and the records are updated
to reflect the selected log.

The log table contains the following fields:

• Date occurred — the date the error or event occurred


• Code — an internal afterloader error code defined in the Description field
• Class — a “1” in this field identifies an event that occurred on the control
PC; a “2”, “6”, or “9” identifies an error that originated from the
afterloader
• Description — a description of the error or event. For errors, this is the
same text that appears when the error message displays.
• User — the login ID of the user logged in at the time of the occurrence
• Date cleared — the date and time the error was cleared (or superseded by
another error). This field is not applicable to events.
• Machine — the machine serial number (entered by a service engineer in
the Owner Information tab of the User & Location Strip)

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You can click on a record to select and highlight it in the table. Click on the
header of a field to sort the records in ascending or descending order using the
values in the selected field. By default, the table is sorted in reverse
chronological order on Date occurred.

Filter the Records in a Log

You can specify a condition for filtering the records in any of the logs to view
a subset of the data in the log. You set up the condition using a field name, a
function (or operator), and a value that you want to match or compare in the
selected field.

Click on the Select Field button to display the list of fields. Click on a field in
the list to select it.

Note: You cannot select the Description field.

Click on the Select Function button to display the list of functions. Click on a
function to select it.

Click on the Enter value field and enter the value that you want to match or
compare.

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Note: The default filtering criterion is “all errors” or “all events”.

Click on the Filter on check box to activate it.

The control software automatically applies the filter and displays the filtered
records in the table. To remove the filter, click on the Filter on check box to
deactivate the filter (remove the check mark) and display the full list of records.

Export a Log
4
You can export the currently displayed log table to a comma separated value
(.CSV) file. Press the Export Location button and select the appropriate
export directory from the drop-down list. By default, the Export Location list
displays the most recently used export directory.

Note: The Export Location button is enabled when the administrator


sets up an export folder in the Folder Setup tab of the User &
Location Strip on the System Configuration Page.

Click on the Export button to export the table to a text file. A confirmation
message indicating the name of the export file is displayed when the export is
complete.

Print a Log

The Print button at the bottom of the Error Log tab enables you to view and
print a report of the currently selected log table, including any filter
information.

Press the Print button to print a hard copy of the report and the Close button
to close the report and return to the Error Log tab.

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Annotate Error Messages


The Annotate Messages tab enables you to add site-specific annotations to
standard afterloader error messages. The annotations display when you press
the View Detail button on a standard error message dialog box. This tab
consists of a sortable table, with each row corresponding to an error message,
and a set of buttons for saving or cancelling the annotations.

View and Select Error Messages

The error message table contains the following fields:

• Error code — an internal afterloader error code defined in the error


message field
• Error message — a description of the error that appears when the error
message displays
• Notes — the optional site-specific notes describing the error

You can click on a record to select and highlight it in the table. Click on the
header of a field to sort the records in ascending or descending order using the
values in the selected field. By default, the table is sorted in ascending order on
Error code.

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Add or Edit a Note

Click on the error message you want to annotate or edit to select it. Click on
the Notes field and enter the textual description (up to 3 lines). Press the Enter
key on your keyboard to enter the text and then press the Save button.

Define a Standard Plan


The Standard Plans tab enables a user with physicist functions privileges to
define, edit, and delete standard plans. Standard plans are collections of
channel and dwell information that can be applied to patient treatment plans
using the Create New Patient File workflow. Using the Standard Plans tab, 4
you can also access regular patient treatment plans, and convert and save them
as standard plans. This tab consists of a sortable table and a set of buttons for
creating and maintaining the plans.

Refer to the “View and Define Fraction Data” under “Create New Patient File
Workflow” in Chapter 2 for information on how to use a standard plan as the
starting point for a patient treatment file.
The Standard plans table contains the following fields:

• Plan name — the name that was entered when the standard plan was
created
• Treatment site — a drop-down list of treatment sites

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• Applicator — a drop-down list of applicators. You can add one or more


applicators to the list using the Applicator Definitions tab. Refer to the
next section for more information.
• Source strength — the planned source strength

Only physicist group users having the Run physics functions privilege can
add, delete, modify, and sort standard plans. Other users may only view this
page.

Add a New Plan

The New button at the bottom of the Standard Plans tab enables you to add a
new standard plan to the Standard plans table. When you press this button, an
empty record appears at the top of the table. Enter the plan name in the Plan
name field.

Press the Enter key or click on the drop-down arrow in the Treatment site list
and select the type of treatment for the plan:

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Click on the drop-down arrow in the Applicator list and select the type of
applicator for the plan:

Click on the Source strength field and enter the planned source strength for 4
the standard plan.

Note: The Treatment site and Applicator are optional for standard
plans.

Press the Save button to save your changes and continue working in the
Standard Plans tab.

Copy a Patient Plan


You can use an existing patient treatment plan as the basis for a new standard
plan. Click on the Copy Patient Plan button. The control software displays a
table containing the patient treatment records that are currently active in the
patient database.

The Patient plans table contains the following fields:

• Patient identification — the patient ID listed in the Patient ID1 field of


the active treatment records database on the Patient Selection Page
• Treatment site — the target location for the treatment
• Delivery status — a ratio of the number of fractions delivered compared
to the total number of fractions in the plan

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Click on the patient treatment plan you want to use to select it in the Patient
plans table. Enter the name you want to use to identify the new standard plan
in the Standard plan name field. Enter the number of the fraction you want to
use in the Fraction field. By default, the value in the Fraction field is the
number of the next fraction to be delivered (or “1” if no fractions have been
delivered) for the selected patient, as displayed in the Delivery status field.

Note: Use the Print button to view the Standard Plan Report and
confirm that the correct fraction has been chosen.

Note: If you are basing the new standard plan on an existing patient
plan, no patient demographic data is included in the new
standard plan.

Press the Save button to save your changes and continue working in the
Standard Plans tab.

View and Edit Channel Information for a Standard Plan

Click on a record in the Standard plans table to select and highlight the plan
in the table. Press the Set Up>> button to display the Treatment Delivery Page.
You can view existing channel information in the Channel View Strip or edit
channel information in the Channel Edit Strip. Refer to the “The Channel Edit
Strip” section in Chapter 2 for detailed information on how to use the Channel
Editor.

Press the Save button in the Channel Edit Strip when you are finished adding
or editing the channel(s) of interest. Press the Previous button in the Treatment
Delivery Page to return to the Standard Plans tab. Press the Cancel button in
the Channel Edit Strip to discard your changes and the Previous button to
return to the Standard Plans tab.

Edit a Record in the Standard Plans Table

Click on the field you want to modify and select or enter the new information
in the Standard plans table.

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Delete a Record

The Delete button at the bottom of the Standard Plans tab enables you to
delete the selected record from the standard plan table. The control software
displays a confirmation message before the deletion occurs.

Print a Standard Plan Report

The Print button at the bottom of the Standard Plans tab enables you to view
the Standard Plan Report.

Press the Print button to print a hard copy of the report and the Close button
to close the report and return to the Standard Plans tab. 4

Maintain the Applicator Definitions


The Applicator Definitions tab enables you to define, edit, and delete
applicator definitions from the control software database. This tab consists of
editable text boxes, a sortable table for the currently defined applicator, with
each row corresponding to a channel, and a set of buttons for maintaining the
applicator definitions.

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View and Select an Applicator Definition

Click on the Applicators button at the bottom of the tab to display a list of the
currently defined applicators. A small set of applicators are included in the
database by default. Click on an applicator name to select it.

The selected applicator name appears in the Applicator name field and the
records in the table are updated to reflect the selected applicator.
The applicator table contains the following fields:

• Channel number — the channel number assigned when the applicator


was defined
• Channel name — the channel name assigned when the applicator was
defined
• Channel length (cm) — fixed at 130 cm for the GammaMedplus iX

You can click on a record to select and highlight it in the table. Click on the
header of the Channel number and Channel name fields to sort the records
in ascending or descending order using the values in the selected field. By
default, the table is sorted in numerical order on Channel number.

Add an Applicator

The Add button at the bottom of the Applicator Definitions tab enables you
to add a new applicator to the Applicator table. When you press this button,
the control software clears the editable text fields and table so that you can add
the new information.

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Enter the name of the applicator you want to define in the Applicator name
field. Enter the name of the manufacturer in the Applicator manufacturer
field.

Press the Add Channel button to add a new channel to the applicator table.
Enter the new channel number in the Channel number field. Press the Enter
key or click on the Channel name field and enter the name for the channel.
The Channel length is fixed at 130 cm for the GammaMedplus iX.

Repeat this process until you have added all of the channels for the applicator.

Note: You cannot define an applicator that uses more than the 24
channels available on the GammaMedplus iX system. 4
If you want to delete a channel, click on the channel in the applicator table to
select it and press the Delete Channel button. The control software displays a
confirmation message before the deletion occurs.

Note: If you delete a channel for an applicator that is currently being


used in a treatment plan, the Applicator name will be changed
to Unspecified when the Treatment Delivery Page is displayed.

Edit an Applicator Definition

Click on the record you want to edit to select it. Click on the field you want to
modify and enter the new information.

Delete an Applicator
The Delete button at the bottom of the Applicator Definitions tab enables you
to delete the selected applicator from the table. The control software displays
a confirmation message before the deletion occurs.

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Copy an Applicator Definition

The Copy button at the bottom of the Applicator Definitions tab enables you
to copy the selected applicator definition. Enter a unique name for the new
applicator definition in the Applicator name field. The new name appears in
the Applicators drop-down list.

Back Up and Restore Files


The Backup & Restore tab enables you to back up and restore control
software data files and export control software diagnostic data. It also allows
you to define the method and frequency with which the data files are backed
up, choose the location for backed up and restored files, and choose the
location for diagnostic files. This tab consists of editable text fields, list boxes
for file locations, and a series of buttons.

The backup procedure includes treatment history files, physics test files,
registry entries, error logs, and other essential data (such as system
configuration options).

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Note: The control software performs a daily backup of the system to


the control PC hard drive, regardless of the settings in the
Backup & restore tab. This backup file is available only to
Varian service engineers. Automatic and/or manual backup of
the system to a network drive or removable media using the
Backup & restore settings is recommended so that you have
access to the backup files.

Perform an Automatic Backup

Select the destination root folder for the files that are automatically backed up
by pressing the File Location button in the Automatically backup console 4
system files group box and choosing the alias name that represents the folder
from the list:

The folder names that appear in the File Location list are configured in the
Folder Setup tab of the User & Location Strip. By default, the most recently
selected location is displayed.

Click on the Backup frequency (days) text field and enter a number. The
number 1 represents an automatic backup every day, 2 is for every other day,
3 for every third day, etc.

Activate the Automatic backup on check box to enable the backup.

Note: Each time the Start Page displays, the control software checks
to see if an automatic backup is required, and, if so, performs the
backup.

Perform a Manual Backup

Select the destination root folder for the files that are manually backed up by
pressing the File Location button in the Manually backup console system
files group box and choosing the alias name that represents the folder from the
list.

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The root folder contains the backup folder, which in turn contains a series of
folders and associated files. Enter the name of the backup folder in the Backup
file field.

Press the Backup button to perform the backup. A confirmation message


appears if the backup file already exists. Another message appears when the
backup is complete.

Restore Files

Select the root source folder from which the files will be restored by pressing
the File Location button in the Restore console system files group box and
choosing the alias name that represents the folder from the list.

Select the backup folder by pressing the Backup File button and choosing the
name of the folder from the list.

Press the Restore button to restore the files. The control software displays a
confirmation message before the restore occurs. Select No to cancel the
restore. If necessary, you can take this opportunity to back up the data first.
Select Yes to begin the restore. When the restore is complete, a confirmation
message is displayed. Press OK to restart the control software.

CAUTION: When you press the Restore button, you will see a warning
indicating that all current data and settings are about to be
replaced by whatever is specified in the recovery file. It is
strongly recommended that you perform a manual backup
before you initiate the file recovery. A restore operation cannot
be undone.

Export Diagnostic Files

You can export control software diagnostic data to a location you specify. The
export of diagnostic files only needs to be performed under the direction of a
Varian Medical Systems service engineer in order to facilitate problem
diagnosis. The exported data can be sent to the service engineer.

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Select the destination folder for the files to be exported by pressing the File
Location button in the Export diagnostic files group box and choosing the
alias name for the folder from the list. This location is specified in the Folder
Setup tab of the User & Location Strip.

Press the Export button to export the files. A confirmation message appears
when the export is complete.

Change System Settings


The System Settings tab enables you to configure and/or view an assortment
of system parameters, including the system date and time, the selected printer, 4
measurement units for source strength, idle system and secure system
time-outs, the dummy wire sequence, and ARIA communication settings. This
tab consists of a table containing editable text fields, drop-down lists, and
check boxes, and a series of buttons.

The system settings table contains the following fields:

• Setting — a list of the settings, grouped by topics: General System


Settings, System Units, Location-Specific Settings, and ARIA
Communication Settings
• Current value — the value for the setting. The values are entered in the
table via text fields, drop-down lists, and check boxes.

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General System Settings

Set the System Date and Time

The Date and time setting enables you to change the date and time in order to
make allowances for Daylight Savings Time or to synchronize the control PC
clock and GammaMedplus iX afterloader clock if necessary. Double-click on
the Current value field for Date and time and make any necessary changes,
using yyyy-mm-dd format for the date and a 24 hour clock. The updated time
values will be applied to the control PC and the GammaMedplus iX
afterloader.

Note: If the updated time value differs more than 60 minutes from the
original time value, the control software displays a warning that
the new value could affect the accuracy of the current source
calibration. The change will be accepted and logged in the event
log.

Note: The new time value cannot differ more than +/- 75 minutes from
the original time value.

Select a Printer

Double-click on the Current value field for the Selected Printer to display a
drop-down list of the printers that are currently available. Select the printer you
want to use for hard copy reports.

Set System Units

You can select which units to display on screen and in reports for the following
parameters:

• Source strength — select Ci, U, or GBq


• Conversion factor — for Source strength set to use U as units, enter the
appropriate value in the Conversion factor field. The value must be in the
range of 4000 and 4100 U/Ci, with a default value of 4070 U/Ci.

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WARNING 4-1: The Conversion factor, when specified in the System Units
section, must match the conversion factor used in the
treatment planning system. The control software uses the
conversion factor when scaling the dwell positions. Failure to
match these values may cause the delivered treatment to differ
from the planned treatment.

Location Specific Settings

Specify Idle System and Secure System Time-outs 4


You can set the Idle time-out or Secure time-out by clicking on the
appropriate field and entering the time in minutes. The logout times work as
follows, from the user’s point of view:
The Secure System button in the User Info Strip at the top of the screen
temporarily secures the system against unauthorized use if you need to step
away from the control PC. This feature also safeguards confidential patient
data in your absence. When you press the button, the Secured System Page
appears. This page displays the username of the person who secured the system
and a password entry field. Only the person who secured the system, an
administrator, or a service engineer can take the system out of secured system
mode. After a period of time specified in the Secure time-out option, the
dialog times out and you are automatically logged off. The Secure System
button is not available during patient treatment.

If a treatment is not currently in progress, and no user activity has been


detected for a length of time set in the Idle time-out option, you will be
switched automatically to secured system mode.

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Specify the Dummy Wire Sequence

There are two options for the Dummy sequence:

• Dummy each/ Active each — alternates sending the dummy wire and
then the active wire out on each channel
• Dummy all/ Dummy each/ Active each —sends the dummy wire out on
all channels first, and then alternates between the dummy wire and active
wire for each channel

Double-click on the Current value field for the Dummy sequence and choose
the appropriate dummy wire sequence.

Note: The option you select applies only to patient treatment plans. It
does not apply to physics test treatments. For test treatments, the
setting always defaults to Dummy each/ Active each.

ARIA Communication Settings

The ARIA Communication Settings enable you to configure the control PC so


that you can import patient treatment files from an ARIA database and send the
treatment status back to the ARIA database. The settings are divided into three
groups — General ARIA Settings, Worklist Service Settings, and Database
Service Settings — in addition to buttons for testing the ARIA settings. For
some of the settings, a Varian BrachyTherapy Service engineer will need to
work in conjunction with a site-specific IT department representative.

General ARIA Settings


• Enable ARIA integration — activate this check box to enable the
interface between the control PC and the ARIA database
• Enable appointment integration — activate this check box to enable the
interface with the ARIA resource scheduler. Activating this check box also
enables the control software to send the treatment status back to ARIA
upon treatment completion
• AE Title — displays the Application Entity initially entered by Varian
BrachyTherapy service. The Application Entity is used by the control
software and ARIA to negotiate a DICOM transfer.

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• IP address — displays the IP address of the control PC in read-only format


• Listen port — designates the port through which the control software
receives incoming data from the ARIA server.
• Machine name — enter the name of the afterloader on which the patient
will be treated

Worklist Service Settings


• Worklist AE Title — enter the name of the worklist service running on
the ARIA server
• Worklist service IP address — enter the IP address for the PC where the 4
worklist service is running (ARIA server)
• Worklist port — enter the numeric value for the listen port for the
worklist service

Database Service Settings


• Database AE Title — enter the name of the database service running on
the ARIA server
• Database service IP address — enter the IP address for the PC where the
database service is running (ARIA server)
• Database port — enter the numeric value for the listen port for the
database service

Test ARIA Settings


• Worklist button —press this button to test the interface with the ARIA
worklist service. For a positive response regarding the connection, the
control software displays a message indicating how many records are
available for retrieval. For a negative response, an error is displayed.
• Database button — press this button to test the interface with the ARIA
database service. For a positive response regarding the connection, the
control software displays a message indicating how many courses of
treatment are currently active. For a negative response, an error is
displayed.

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Perform Physics and Service Functions


The Source & Wire Strip enables all users to view settings related to source and
wire characteristics. Users with appropriate access privileges can configure
these same settings. The administrator for the control software can enable or
disable access privileges using the Groups tab on the User & Location Strip.
Click on the Source & Wire button on the System Configuration Page to open
the Source & Wire Strip.

This strip consists of the following tabs:

• Test Plans — set up and execute physics test treatments (physicists only)
• Source Strength — enter the calibrated source strength (physicists only)
• Source Exchange — specify data about source and dummy wire
installations (Varian service engineers only)
• Service Parameters — specify data relating to tasks performed by service
engineers (Varian service engineers only)
• System Commands — exit to the operating system and perform other
tests (Varian service engineers only)

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Create and Deliver Physics Test Plans


The Test Plans tab enables you to set up and execute physics test plans. Each
test plan is a single fraction plan that is not associated with an actual patient.
By default, the ability to modify settings in this tab is only available to users
with physicist group privileges. The Test Plans tab consists of a sortable table
listing the test plan names, and a set of buttons for creating, maintaining, and
executing the test plans.

WARNING 4-2: Physics test plans must not be used for the treatment of
patients. Doing so may cause serious injury to the patient. It is
essential that you develop and use a fail proof method for
distinguishing test treatment and patient treatment files.
Varian Medical Systems accepts no responsibility if a
physics test plan is delivered to a patient as treatment.

The Test plans table contains the following fields:

• Plan name — the name of the test plan that was assigned when the plan
was created
• Source strength — the planned source strength

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• Absolute value dwell times — when this check box is activated, the
control software does not scale the dwell times to account for the current
source strength; when the check box is deactivated, the control software
adjusts the dwell times to account for the current source strength
• Console entry date — the date the test plan was created

If you have physicist group privileges, you can click on the header of a field to
sort the records in ascending or descending order using the values in the
selected field.

Add a New Plan

The New button at the bottom of the Test Plans tab enables you to add a new
test plan to the Test plans table. When you press this button, the Physics Test
Plan Setup Strip appears. You can use the options in this strip to create a
fraction with a set of channels having identical dwell characteristics.

Enter the appropriate values in the following fields:

• Plan name — the name you want to use to identify this specific test plan
• Planned source strength — source strength to use for the test plan (value
must be between 0.000 and 15.000 Ci). Your test plans should reflect the
source strength that is allowed by your license.

Note: This field is editable only if the check box for Absolute value
dwell times is not activated (not checked).
• Absolute value dwell times — if checked, specified dwell times will not
be scaled to account for the current source strength
• Number of channels — the number of channels for the test plan (value
must be between 1 and 24)
• Channel length (cm) — length is fixed at 130 cm for the
GammaMedplus iX
• Starting dwell position (cm) — the location for the first dwell position
(range of values depends on the Distal Offset and Step Size)
• Number of dwells — the number of dwell positions in each channel (value
must be between 1 and 60)

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• Time per dwell (s) — the dwell time for each position (value must be
between 0.1 and 9999.9 sec)
• Step size (cm) — the distance between each dwell position in cm (value
must be between 0.1 and 1.0 cm)
• Distal offset — the offset from the distal position of the source. A value of
0.0 cm represents the full 130.0 cm channel length; a value of 20.0 cm
represents a 20.0 cm offset from the 130.0 cm channel length, or a
110.0 cm distal position (value must be between 0.0 and 40.0 cm)

Press the Save button to save your Test Plan setup and continue working in the
Test Plans tab.
4

Print a Physics Test Report

When you press the Print button at the bottom of the Test Plans tab, the
Physics Test Report appears.

Press the Print button to print a hard copy of the report or the Close button to
close the report and return to the Test Plans tab.

Copy a Patient Plan to be Used as a Test Plan

You can use an existing patient treatment plan as the basis for a new physics
test plan. Click on the Copy Patient Plan button. The control software
displays a table containing the patient treatment records that are currently
active in the patient database.

The Patient plans table contains the following fields:

• Patient identification — the patient ID listed in the Patient ID1 field of


the active treatment records database on the Patient Selection Page
• Treatment site — the target location for the treatment
• Delivery status — a ratio of the number of fractions delivered compared
to the total number of fractions in the plan

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Click on the patient treatment plan you want to use to select it in the Patient
plans table. Enter the name you want to use to identify the new test plan in the
Test plan name field. Enter the number of the fraction you want to test in the
Fraction field. By default, the value in the Fraction field is the first
undelivered fraction, or the last fraction (if all fractions have been delivered),
as displayed in the Delivery status field.

Note: If you are basing the new test plan on an existing patient plan,
no patient demographic data is included in the new test plan.

Print a Physics Test Report


You can view or print a copy of the Physics Test Report by pressing the Print
button.

Press the Print button to print a hard copy of the report or the Close button to
close the report and return to Patient Plans area of the Test Plans tab.

Press the Save button to save your changes and continue working in the Test
Plans tab. Press the Cancel button to return to the Test Plans tab without
saving your changes.

Execute a Physics Test Plan

In order to execute a test treatment, press the Run Plan button at the bottom of
the Test Plans tab to display the Treatment Delivery Page. The control
software prominently displays the following warning message near the top of
this page:

WARNING — PHYSICS TEST USE ONLY — NOT FOR PATIENT


TREATMENT

WARNING 4-3: Do not use a physics test plan to deliver a treatment to a


patient. Doing so may cause serious injury to the patient.
Varian Medical Systems accepts no responsibility if a
physics test plan is delivered to a patient as treatment.

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The workflow on the Test Plan Initiation and Test Plan Delivery Strips on the
Test Plan Delivery Page for physics test plans is similar to the workflow for
patient treatment plans, with the following exceptions:

1. When you press the Start Test button, a Planned Treatment Report is not
generated. The dwell times are adjusted using the current source strength
only if you have deactivated the Absolute value dwell times check box in
the Test plans table on the Test Plans tab.
2. In the Test Plan Delivery Strip, enter your logon Password instead of a
Treatment Code.

Refer to the “Deliver and Monitor the Treatment” section in Chapter 3


“Delivery of Patient Treatment” for a detailed description of test plan initiation 4
and delivery.

WARNING 4-4: All persons must leave the treatment room before the
delivery of a physics test plan begins.

Edit a Physics Test Plan

In the Test plans table, click on the test plan you want to edit to select it. Click
on the field you want to modify and enter the new information. Use the
Channel Editor to edit channel and dwell data for the test plan. You can access
the Channel Editor by pressing the Run Plan button on the Test Plans tab. For
more information on editing a channel, refer to the “The Channel Edit Strip”
section in Chapter 2 “Patient and Treatment Data”.

Delete a Physics Test Plan

The Delete button at the bottom of the Test Plans tab enables you to delete the
selected test plan from the table. The control software displays a confirmation
message before the deletion occurs.

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Enter the Calibrated Source Strength


The Source Strength tab enables a user with appropriate privileges to enter the
site calibrated strength of the source. By default, the ability to modify settings
in this tab is only available to users with physicist group privileges. All other
users may view the source strength data in the tab.

Note: You must enter a Site calibrated source strength value after a
source exchange before delivery of any patient treatment in
order to meet calibration requirements set forth by the USNRC
and other local Competent Authorities. After a source
exchange, the control software displays a message to this effect
when you log on until you enter a site calibrated source strength.

Note: If the afterloader is moved to any location outside the facility,


the USNRC requires that prior to patient treatment a full
calibration be conducted. Each time the unit is relocated, it must
undergo full calibration. The control software does not check to
ensure the recalibration has been completed. For countries other
than the United States, check the regulations set forth by the
local Competent Authority.
The Source Strength tab consists of a Source strength table and editable text
fields: Site calibrated source strength, Calibration date, and Password.

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The values in the Source strength table are as follows:

• Manufacturer source strength — The calibrated source strength and


date of calibration are taken from the wire serial number as entered in the
Source Exchange tab. The time of calibration is assumed to be 12:00 noon
in the time zone of the manufacturer.
• Site calibrated source strength — The date and source strength values
you enter in the Site calibrated source strength field in the Set site
calibrated source strength area.

Important: Use the Site calibrated source strength as the base line source
strength to calculate the current source strength with a source 4
decay table. Refer to the “Source Decay” section in Appendix B
“GammaMedplus iX Calculations” for more information. The
Site calibrated source strength is the value that must be
entered in the BrachyVision treatment planning software.

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Enter the Site Calibrated Source Strength

To start this procedure, turn the MODE key switch on the Control Console to
the horizontal position. The SPECIAL indicator light turns on.

The control software decays the source by one day at 12:00 midnight according
to the formula in the “Source Decay” section of Appendix B “GammaMedplus
iX Calculations”. An Ir-192 Source Decay Table is also included in
Appendix B.

Note: For the GammaMedplus iX system, there is no need to select a


decay frequency using the Decay Frequency button at the
bottom of the tab.

You can use the calibrated source strength and calibration date on the
manufacturer’s certificate or enter the source strength determined during your
own source strength calibration. Enter the value of the source strength in the
Site calibrated source strength field in units of either Ci, U, or GBq,
depending on the System units setting for the Source strength in the System
Settings tab of the Console & Afterloader Strip. Enter the Calibration date
that corresponds to the source strength in yyyy-mm-dd format. Enter your
logon Password and press the Save button to save the calibrated source
strength.

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The control software checks to see if the new source strength is within an
acceptable range, as follows:

• If the new source strength is within 0–5% of the Manufacturer measured


source strength, the control software displays a message confirming the
new value. This message appears even if the value you enter is equal to the
value on the manufacturer’s certificate.
• If the new source strength is within 5–10% of the Manufacturer
measured source strength, the control software displays a message
warning that the new strength differs by more than 5% of the
Manufacturer measured source strength and requests confirmation to
continue.
4
• If the new source strength differs by more than 10% of the Manufacturer
measured source strength, the control software displays a message that
it is unable to set the new source strength. In this case, recheck the
calibration, and, if necessary, call a Varian Medical Systems service
engineer.

WARNING 4-5: Adjustment of the source strength should be done only by a


qualified physicist after performing an appropriate
measurement of the source strength. Entering an incorrect
value in the Site calibrated source strength field will result
in incorrect treatment times and can cause severe danger to the
patient by over– or underdosing.

Once accepted, the new source strength is used as the basis for the decay
calculations. This change is logged in the event log with the current user’s
logon ID. The Current source strength in the System Status Strip is
recalculated to reflect the new calibration. Relevant printouts and system
information will indicate the current source strength.

When finished, return the MODE key switch to the vertical (NORMAL)
position, remove the key, and place it in a secure location.

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View Source Exchange Data


The Source Exchange tab enables service engineers to specify data about
source and dummy wire installations. By default, the ability to modify settings
in this tab is only available to users with service engineer group privileges
using SPECIAL mode. All other users may view the data in the Active wires
and Dummy wires tables.

When a new source or dummy wire is physically installed in the


GammaMedplus iX, the service engineer must inform the control software of
the new serial number. This information is entered and downloaded to the
battery SRAM of the GammaMedplus iX. The information is also recorded in
the event log.

This tab consists of two tables, one for active wires and one for the dummy
wires. There is also a set of buttons for maintaining the tables.

Note: The record for the most recently installed active and dummy
wire appears at the top of the respective table. The record of the
wire currently in use is highlighted.

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Print a Wire Exchange Report

When you press the Print button at the bottom of the Source Exchange tab,
the Wire Exchange Report appears. The top section of the report includes the
user logged on at the time the report is printed, clinic (institution name),
afterloader serial number, and the date and time the report is printed.
The report is divided into the following main sections — Maximum Strength
Values, Active Wire Exchange History, and Dummy Wire Exchange History,
with each section displaying the information contained in the active and
dummy wire tables and group box.

Press the Print button to print a hard copy of the report or the Close button to
close the report and return to the Source Exchange tab. 4

Select a Wire Type

Click on the Wire Type button at the bottom of the tab and select the type of
wire whose data you wish to view (active or dummy).

The Active wires table contains the following fields:

• Wire serial — serial number of the new wire


• Exchange date — date and time of the source wire exchange (read only
field). This date is used for the Days since last source exchange indicator
on the System Status Strip. The indicator shows how many days have
passed since the last source exchange. The number of days available for a
given wire is 120. If the number of days since the last exchange is greater
than 90, the icon displays in red, and a warning message pops up at user
log on. After 120 days have elapsed, you are prohibited from delivering
treatments.
Note: Under extenuating circumstances, in coordination with a Varian
service engineer, a special one-time password may be issued
that enables you to add up to 15 days for the current source wire.

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• Total/ used cycles — maximum number of source wire cycles/ number of


source wire cycles used at the time of source exchange (or at the time the
record is added to the table in the case where a different afterloader is
connected to the control PC), taken from the battery RAM (afterloader
memory) (read only field)
• Machine — the machine serial number (entered by a service engineer in
the Owner Information tab of the User & Location Strip)
• Notes — comments added by the service engineer

The Dummy wires table contains the following fields:

• Wire serial — serial number of the new wire


• Exchange date — date and time of the dummy wire exchange (read only
field)
• Total/ used cycles — maximum number of dummy wire cycles/ number
of dummy wire cycles used at the time of dummy wire exchange, taken
from the battery RAM (afterloader memory) (read only field)
• Machine — the machine serial number (entered by a service engineer in
the Owner Information tab of the User & Location Strip)
• Notes — comments added by the service engineer

View the Maximum Source Strength Values

The Physical field in the Maximum source strength values group box
displays the value for the maximum source strength for which the afterloader
is designed. The At exchange edit field displays the maximum source strength
that can be installed in the afterloader as allowed by the USNRC, Agreement
State, or Competent Authority. The At treatment field displays the maximum
source strength that can be used at treatment as allowed by the USNRC,
Agreement State, or Competent Authority. The service engineer specifies the
value for the At exchange and At treatment fields.

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Specify Service Parameters


The Service Parameters tab displays wire drive and wire cycle parameters.

Print a Service Parameters Report

When you press the Print button at the bottom of the Service Parameters tab,
the Service Parameters Report appears. The top section of the report includes
the user logged on at the time the report is printed, clinic (institution name),
serial number, and the date and time the report is printed.

The report is divided into two main sections — Wire Drive – Specific
Parameters and Wire Cycles. Each section displays the cycles for the active
and dummy drives and wires, respectively.

Note: Regardless of locality, this tab always displays in English, since


it is used only by service engineers.

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Perform System Commands


The System Commands tab is intended for use by authorized service
personnel only.

Note: Regardless of locality, this tab always displays in English, since


it is used only by service engineers.

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Chapter 5 Emergency Procedures


The GammaMedplus iX system is equipped with multiple independent safety and
alarm functions that reduce the risk of uncontrolled radiation exposure in the event of
an operational error or system malfunction. If an emergency situation should occur, the
primary objective is to get the source out of the patient and into shielded storage. This
chapter describes the recommended procedures that support this objective. These
procedures are summarized in flowchart format in Figure 5-1 Emergency Response
Procedures and in text format following the figure. Refer to the “Emergency Response
Procedures (for posting)” section in Appendix D, “Safety Information and Tests” for
procedural information that you can post at your facility.
It is imperative that essential personnel familiarize themselves with and regularly
rehearse all of the emergency response procedures required at your site. Many
regulatory agencies require that operators, physicists, and physicians participate in
drills of emergency procedures initially and at least annually thereafter.
5
All users are advised to carefully read the safety information included in the
“Important Safety Information” section of Chapter 1. For additional safety
information, including safety tests and checks, refer to Appendix D “Safety
Information and Tests”.

WARNING 5-1: After an emergency, the physical condition of the source wire cannot
be known unless it is inspected by a Varian Medical Systems service
engineer. If there is any possibility that a GammaMedplus iX source
wire has been damaged, you must contact Varian Medical Systems
before treatment may resume. A damaged wire may fail to properly
track through the GammaMedplus iX unit.

In This Chapter

Topic Page

Emergency Contact Information 5-2


Definition of Emergency 5-3
Precautions, Limitations, and Prerequisites 5-3
Emergency Features and Functions 5-6
Automatic and Emergency Retraction of the Source 5-11
Emergency Response Procedures 5-14
How to Continue an Interrupted Treatment 5-22

5-1
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Emergency Contact Information


In the United States, please call:
GammaMed Dispatch 1-800-864-1672 (24 hour service)

In the event of an emergency, contact the following:

David Kuligowski/ BrachyTherapy Service Supervisor


Varian Medical Systems
700 Harris Street, Suite 109
Charlottesville, Virginia 22903
Office: 847-543-1293
Fax: 847-543-1293
Cell: 847-910-3717

Stephen Crawford/ BrachyTherapy Service Manager


Varian Medical Systems
700 Harris Street, Suite 109
Charlottesville, Virginia 22903
Office: 1-888-666-7847 ext. 239
Fax: 434-244-7181
Cell: 408-887-9892

For all sites outside of the United States and Canada, please contact your
regional service office, as applicable.

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Definition of Emergency
In the context of this document, an emergency is defined as a radiation hazard
to the operator or patient that occurs as the result of a system malfunction or an
error in a treatment sequence. In such an emergency, you must follow the
sequence below without skipping a step:

1. Automatic retraction of the source — The GammaMedplus iX system


detects the error and automatically retracts the source into the shielded
position.
2. Emergency retraction under machine power — The operator of the
GammaMedplus iX system detects the error and presses one of the
emergency buttons (INTERRUPT button, EMERGENCY RETURN
switch, or EMERGENCY button) to cause the source to retract into the
shielded position. 5
3. Emergency retraction using emergency handcrank — The operator of
the GammaMedplus iX system detects the error and performs a manual
retraction of the source into the shielded position using the handcrank.
4. Manual recovery of the source — If the source cannot be retracted using
the handcrank, the wire may be kinked, there might be a mechanical
malfunction of the source drive mechanism, or the source might be severed
from the wire. In this case, the source must be recovered manually.

As mentioned above, during an emergency, it is imperative that you remove


the source from the patient and secure it in shielded storage.

Precautions, Limitations, and Prerequisites


The source strength of the Iridium-192 HDR source is typically 370–407 GBq
(10–11 Ci) when it is installed, both initially and during routine source
exchanges. Dose rates are on the order of 490 Gy/hr (49,000 Rad/hr) at 1 cm
and 3 cGy/hr (3 Rad/hr) at 1 meter. Always practice radiation safety when
working with the HDR source, always use a calibrated portable meter, and
always wear your dose monitoring badge.

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Precautions

WARNING 5-2:Fundamental rules in case of radiation hazard:


• Carry a radiation monitoring instrument.
• Spend as little time as possible in the field of radiation.
• Keep the maximum possible distance from the source of radiation.
• If necessary, move the source as quickly as possible into the shielded
position or Emergency Container.

Failure to follow emergency response procedures may result in serious


injury to the patient or operator of the system.

• All persons engaged in the use of the GammaMedplus iX system must be


trained in the safe operation of the device. They must be familiar with the
safety features and emergency response procedures.
• All members of the treatment team should conduct practice drills in
emergency response.
• The EMERGENCY RESPONSE procedures must be posted near the door
outside the treatment room. The Emergency Container (including forceps
and pliers) must be accessible in the treatment room.

Limitations
The procedures recommended in this chapter may or may not encompass every
emergency you may encounter. For example, you may experience an
emergency situation resulting from a fire or earthquake, neither of which is
addressed in this chapter. This information is provided as guidance only.
Formal emergency procedures must be adopted by your facility in compliance
with your license and local regulations.

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Prerequisites
All of the safety features in the “Important Safety Information” section of
Chapter 1, “Introduction” must be satisfied in addition to the emergency
equipment and radiation safety officer prerequisites stated below. Only
properly trained and authorized persons should operate the HDR unit. All
personnel working with or around the HDR unit must be trained in radiation
safety.

Emergency Equipment

The emergency equipment at your facility must be operational according to the


manufacturer’s specifications. The following emergency equipment must be
readily available at all times:
5
• A pair of long handled forceps (~ 30 cm)
• A pair of pliers
• Shielded emergency container
• Heavy duty wire cutters
• Personal dosimeter
• Portable survey meter
• Stop watch or timer

Radiation Safety Officer (RSO)

The radiation safety officer is responsible for ensuring that all radiation safety
procedures and policies are appropriate. The RSO should have proper training
in the operation of the HDR unit and should actively participate in the initial
and annual practice of HDR emergency procedures.

During an actual emergency, it may not be practicable to contact the RSO


immediately at the beginning of the emergency. Despite this, the RSO should
be contacted as soon as possible after an emergency is detected.

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Note: In case of emergency (e.g. if the source is not retracted


automatically), the persons responsible for radiation protection
are obliged to remove other persons, e.g. patients, out of
radiation areas.

Emergency Features and Functions


The alarm and radiation indicators of the GammaMedplus iX system provide
immediate feedback on system and treatment status.

Alarm Indicators
When an error condition occurs, the red ALARM indicator in the ALARM
section of the Control Console flashes, and an audible warning signal can be
heard.

ALA
ALARM
ARM

On the control PC, a red message box at the bottom of the screen indicates an
error condition and the possible cause of the alarm.

If there is a communication failure between the control PC and the


GammaMedplus iX, an audible alarm will be heard on the control PC. The
alarm continues until communications are restored.

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Turn Off the Audible Alarm Signal


The audible ALARM signal draws attention to the emergency situation. You
can turn off the audible signal by pressing the BUZZER OFF button in the
ALARM section of the Control Console. In this case, the BUZZER OFF
indicator light turns on and the red ALARM indicator continues to flash. If the
error condition remains uncleared, the audible signal will sound again in 5
minutes.

ALA
ALARM
LARM
ARM

DOS
ZER
FF

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Resolve the Cause of the Alarm


Verify that the SAFE indicator light in the SOURCE section of the Control
Console is lit and the RADIATION indicator is off.

Check the error message on the control PC for an indication of the possible
cause of the alarm, and resolve the problem. Press the View Detail button in
the error message box to see additional information. Refer to the “Status and
Error Messages” section in Chapter 3 “Delivery of Patient Treatment” for
more information.

WARNING 5-3: If the SAFE indicator light is not lit, and the RADIATION
indicator is on, follow the emergency procedures at your
site. Refer to the “Automatic and Emergency Retraction of
the Source” section below for more information.

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Reset the Alarm


In order to accept the alarm condition and recover the treatment process, you
must press the ALARM RESET button on the Control Console. The red
flashing ALARM indicator is reset and the buzzer is automatically turned off.

Note: If you do not correct the cause of the alarm, the alarm signal is
repeated when you press the START button.

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Radiation Indicators
Indication of radiation from an unshielded source is detected and displayed by
multiple methods on the GammaMedplus iX system.

Built-in Radiation Detector

The built-in Geiger-Müller detector of the GammaMedplus iX is energized as


long at theGammaMedplus iX is turned on and in treatment mode. In this
configuration, it detects any radiation while the source is outside the shielded
tungsten safe.

Radiation Indicator on the Afterloader Keypad

On the afterloader keypad, the RADIATION indicator light illuminates when


the GammaMedplus iX detects radiation outside the shielded safe. This shows
that the source is no longer in the shielded position and that there is the
potential of radiation hazard.

Note: Other sources of radiation in range of the built-in Geiger-Müller


detector may be detected by it and may cause the radiation
indicator on the afterloader keypad to illuminate.

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Radiation Indicator on the Control Console

On the Control Console, the yellow SOURCE OUT indicator and the yellow
RADIATION symbol illuminate when the source is outside the shielded safe.

5
Independent Radiation Monitoring System

An independent radiation monitoring system with visual and audible output is


required in the treatment room. This monitor indicates radiation when the
source is outside the shielded position.

Automatic and Emergency Retraction of the Source


The automatic safety functions of the GammaMedplus iX are activated if a
radiation hazard occurs as the result of a system malfunction or an error in the
treatment sequence. Alarm signals appear on the Control Console and control
PC, and the source is automatically retracted into the shielded position.

There are situations in which you might need to manually interrupt a treatment,
such as an emergency that requires immediate entry into the treatment room,
or in the unlikely event that automatic source retraction does not occur when
necessary.

Note: The GammaMedplus iX system logs all errors in the treatment


sequence in the error log.

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You can initiate an emergency retraction of the source wire using the following
methods:

• Press the INTERRUPT button on the Control Console.


• Press the EMERGENCY RETURN switch in the control room.
• Press the EMERGENCY button on the afterloader keypad.
• Use the handcrank to return the source to the shielded position.

If emergency retraction of the source is not possible using the actions stated
above, manual recovery of the source must be performed. Manual recovery
means removing the source from the patient without the use of the
INTERRUPT button, EMERGENCY RETURN switch, EMERGENCY
button, or handcrank. Emergency retraction and manual recovery procedures
are outlined in Figure 5-1 and described in detail in the sections below.

WARNING 5-4: The radiation safety officer must be informed immediately in


an emergency situation. Emergency response procedures must
be performed quickly and accurately in order to assure the
safety of the patient and medical staff. Avoid panic and calm
the patient. Practice emergency response procedures with the
staff on a regular basis in order to assure patient and operator
safety.

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Source Press INTERRUPT button or EMERGENCY


EMERGENCY RETURN
Source wire retracted into the afterloader

retracted RETURN
switch. SWITCH
If source still
not retracted
EMERGENCY
button
Enter treatment room
with survey meter. DUMM

DUMM
Y-CHAN

Y-WEC
GE

HSEL

Source Press EMERGENCY button


retracted on the afterloader keypad.
Handcrank
If source still
not retracted

Turn Emergency Handcrank


Source until resistance noticeable or
retracted radiation level safe.

If source still
not retracted

Can applicator be 1. Disconnect all connectors


5
removed easily? No from the Indexer.
2. Pull the afterloader away
from the patient until the wire
Yes is visible at the Indexer.
3. Using the forceps or pliers,
grab the wire and pull it to
Remove the applicator from remove it completely from
the patient and, if possible, the applicator / catheter.
place it in the emergency 4. Place the active end of the
container source wire in the
Emergency Container.

Immediately move patient to the room entrance and monitor

Are dose rates on patient at background level?


YES NO

Monitor all other areas, Return patient to room.


close and lock the If not already done,
door. remove applicators. If
patient levels still
remain above back-
ground, emergency
Emergency surgical recovery will
Container Call Varian Medical be necessary.
Systems.

Emergency retraction under machine or manual power If the source is stuck in


the patient, it must be
Manual recovery of the source removed surgically as
quickly as possible and
Patient monitoring stored in an emergency
container.
Intervention to remove source

Figure 5-1 Emergency Response Procedures

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Emergency Response Procedures


The following sections describe Figure 5-1 “Emergency Response
Procedures” in detail, beginning with the first emergency procedure listed in
the flowchart. Refer to the “Emergency Response Procedures (for posting)”
section in Appendix D, “Safety Information and Tests” for a version of the
procedures that you may post.

Press the Interrupt Button or Emergency Return Switch


In case of an emergency situation, such as one that requires immediate entry
into the treatment room, do one of the following:

• Press the INTERRUPT button on the Control Console to retract the


source at normal speed or
• Press the EMERGENCY RETURN switch in the control room to retract
the source at maximum speed.

EMERGENCY RETURN
Switch

ALA
ALARM
ARM

INTERRUPT Button

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WARNING 5-5: Verify that the SAFE indicator light in the SOURCE
section of the Control Console is on, and the RADIATION
symbol is off. If not, implement the next step of the
emergency response procedures as described in Figure 5-1
above.

Important: If you press the EMERGENCY RETURN switch during


treatment delivery when the active wire is extended, the
radiation symbol in the System Status Strip of the control PC
continues to flash even if the active wire has been retracted into
the shielded position. The symbol continues to flash because
communication between the control software and afterloader
has been interrupted. 5
The control software displays the following message:
“WARNING: EMERGENCY MANUAL. Waiting for
afterloader to restart.” Audible signals can be heard from both
the afterloader and control PC.

Be sure to follow emergency response procedures concerning


detection of radiation as outlined in the warning above. The red
flashing error message and the flashing radiation symbol
display until you pull the EMERGENCY RETURN switch out
and press the ALARM RESET button.

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Press the Emergency Button


If the source wire does not retract into the shielded position after pressing the
INTERRUPT button or the EMERGENCY RETURN switch, enter the
treatment room with a portable survey meter and press the EMERGENCY
button on the keypad of the GammaMedplus iX.

When you press the EMERGENCY button on the afterloader keypad, the
GammaMedplus iX does the following:

• Terminates external power


• Shuts down all console lamps, indicators, and the Geiger-Müller detector
• Initiates emergency battery power that is exclusively directed to the source
drive to retract the source wire into the safe, shielded position

Note: It is important to understand that the sole purpose of the


EMERGENCY button is to retract the source into the shielded
position.

WARNING 5-6: ATTENTION: RADIATION HAZARD!


Emergency retraction of the source using the EMERGENCY
button on the afterloader keypad may expose the operator to
high levels of radiation. Persons under the age of 18 years and
pregnant women are not allowed to perform this task.

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WARNING 5-7: When you press the EMERGENCY button on the afterloader
keypad, the external power supply of the GammaMedplus iX
is switched off, and the source is retracted at maximum speed.
After that, all remote monitors, including the Control Console
and on-board radiation monitoring, are also turned off. The
only indication whether the source is in the shielded position
is the independent radiation monitoring system installed in the
treatment room and your portable survey meter. Confirm that
radiation levels are at background level. If not, initiate the next
step of the emergency response procedures as described in
Figure 5-1.
Failure to follow these procedures may result in the following:

• Source may still be in the patient and you will not be aware
of this.
5
• Source may be outside the shielded position and will
expose the operator and patient to high levels of external
radiation.

Important: If you press the EMERGENCY button during treatment


delivery when the active wire is extended, the radiation symbol
in the System Status Strip of the control PC continues to flash
even if the active wire has been retracted into the shielded
position. The symbol continues to flash because communication
between the control software and afterloader has been
interrupted.

The control software displays the following message:


“WARNING: EMERGENCY MANUAL FROM TROLLY.
Waiting for afterloader to restart.” Audible signals can be heard
from both the afterloader and control PC.

Be sure to follow emergency response procedures concerning


detection of radiation as outlined in the warning above. The red
flashing error message and the flashing radiation symbol
display until you turn the POWER key switch on the Control
Console to the OFF and then the ON position.

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Perform Emergency Retraction with Emergency Handcrank

Note: Remember that when you press the EMERGENCY button on


the afterloader keypad, all indicators and indicator lights are
disabled. Radiation detection is provided only by the
independent radiation monitoring equipment.

In the unlikely event that emergency retraction of the source does not occur
after pressing the INTERRUPT button, the EMERGENCY RETURN
switch, or the EMERGENCY button, the source can be retracted manually
into the shielded position using the handcrank.

WARNING 5-8: ATTENTION: RADIATION HAZARD!


Manual recovery of the source using the handcrank may expose
the operator to high levels of radiation. Persons under the age of
18 years and pregnant women are not allowed to perform this
task.

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WARNING 5-9: ATTENTION: RADIATION HAZARD!


Act quickly but carefully. Keep the maximum possible distance
from the source. All operational personnel must be trained in
radiation safety and emergency procedures as well as all
functions of the GammaMedplus iX.

Follow these steps to manually retract the source using the handcrank:

1. Enter the treatment room with a portable survey meter and go straight to
the GammaMedplus iX.
2. Pull the handle out of the handcrank and turn the crank in the direction of
the arrow until a distinct resistance is noticeable and the room radiation
level is safe.
5
Note: If the source wire has been retracted and the radiation level is
still high or if manual retraction of the source is not possible
using the handcrank, follow the procedures in the “Perform
Manual Recovery of the Source” section below. These
procedures are also outlined in Figure 5-1.

CAUTION: If emergency retraction of the source by handcrank is necessary,


the primary goal is to ensure patient safety. Do not restart the
treatment. Call your Varian BrachyTherapy service
representative immediately to arrange an afterloader inspection.

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Perform Manual Recovery of the Source


In the unlikely event that you are unable to perform motor-driven or manual
emergency retraction of the source, manual recovery of the source is required
immediately. If the source cannot be retracted with the handcrank, the wire
may be kinked or there might be a mechanical malfunction of the source drive
mechanism. If the wire was retracted but the radiation level is still high, the
source might be severed from the wire.

WARNING 5-10:ATTENTION: RADIATION HAZARD!


Manual recovery of the source may expose the operator to high
levels of radiation. Persons under the age of 18 years and
pregnant women are not allowed to perform this task.

WARNING 5-11: ATTENTION: RADIATION HAZARD!


Act quickly but carefully. Keep the maximum possible distance
from the source. All operational personnel must be trained in
radiation safety and emergency procedures as well as all
functions of the GammaMedplus iX.

Remove the Applicator from the Patient


If you can easily remove the applicator from the patient, follow the steps
below. Otherwise, continue to the next section.

1. Enter the treatment room with a portable survey meter and personal
dosimeter.
2. Calm the patient.
3. Open the Emergency Container.
4. Remove the applicator carefully from the patient using the long handled
forceps whenever possible. Maintain the maximum possible distance from
the patient and the afterloader.

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5. If possible, place the applicator in the Emergency Container, being careful


not to damage or kink the source guide tube.
6. Move the patient to the room entrance and monitor the patient’s radiation
levels.
7. If there is no indication that the source is still in the patient, remove
him/her from the treatment room. Monitor the patient’s radiation levels.
8. If the radiation levels are at background level, close and lock the door to
the treatment room and place a warning sign on the door indicating that the
source is exposed.

Pull the Source Wire from the Applicator


If you cannot easily remove the applicator from the patient, follow the steps 5
below:

1. Open the Emergency Container.


2. Disconnect all connectors from the indexer head.
3. Pull the afterloader away from the patient until the wire is visible at the
indexer.
4. Using the forceps or pliers, grab the wire and pull it to remove it
completely from the applicator and/or source guide tube.
5. Immediately place the active tip of the source wire in the Emergency
Container.
6. Move the patient to the room entrance and monitor the patient’s radiation
levels.
7. If the patient survey confirms the source is no longer in the patient, secure
the door to the treatment room and contact the radiation safety officer
immediately.
8. If the patient survey indicates the source is still in the patient, return the
patient to the treatment room and remove any applicators (if still present).
9. After removal of the applicator, monitor the patient’s dose levels to ensure
the source is no longer in the patient.
10. If the levels indicate the source is still in the patient, emergency surgical
recovery of the source will be necessary.

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Note: In all cases above, remove the patient from the immediate area,
survey the patient, and, if safe to do so, evacuate the patient
from the room. Post a warning and notify all emergency
contacts immediately. Since, in most jurisdictions, you will be
expected to report on estimated exposure to staff and patient as
a result of the incidents, you would be advised to estimate times
and dose rates involved to produce a reasonable estimate of
exposure to all concerned.

How to Continue an Interrupted Treatment


The following sections describe how to continue an interrupted treatment.

Important: When continuing an interrupted treatment, ensure that the


power to both the afterloader and control PC is ON so that
communication between these devices is established.

Restart After Pressing the INTERRUPT Button

Follow these steps to restart the system after interrupting the treatment:

1. Resolve the cause of the interruption or alarm.


2. Inform and calm the patient.
3. Press the START button on the Control Console.

The GammaMedplus iX resumes the treatment from the last dwell position,
and only the remaining dwell positions in the current fraction will be delivered.

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Important: In the case where you have pressed the INTERRUPT Button
and need to stop and resume the treatment at a later time, you
can press the EMERGENCY RETURN switch, the
EMERGENCY button, or turn the POWER key switch on the
Control Console off and then back on (after waiting sufficient
time for the system to shut down). Each of these methods causes
the control software to display the Partial Treatment Options
where you can choose to abort the treatment.

Restart After Pressing the EMERGENCY RETURN Switch


Follow these steps to restart the system after pressing the EMERGENCY
RETURN switch:

1. Resolve the cause of the interruption or alarm. 5


2. Inform and calm the patient.
3. Pull the EMERGENCY RETURN switch to the “OUT” position.
4. Press the ALARM RESET button on the Control Console.
5. Use the Partial Treatment Strip in the control software to determine how to
continue the treatment.

The control software displays a Treatment Delivery Report containing data on


the interruption in treatment. When you close this report, the Patient Selection
Page is displayed.

Restart After Pressing the EMERGENCY Button

Follow these steps to restart the system after pressing the EMERGENCY
button:

1. Inform and calm the patient.


2. Resolve the cause of the interruption or alarm.
3. Turn the POWER key switch on the Control Console to the OFF and then
the ON position.
4. Use the Partial Treatment Strip in the control software to determine how to
continue the treatment.

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The control software displays a Treatment Delivery Report containing data on


the interruption in treatment. When you close this report, the Patient Selection
Page is displayed.

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Chapter 6 Functions Performed by Service


Personnel

This chapter includes a general description of the functions performed by


service personnel on the GammaMedplus iX system. Detailed information for
service engineers is included in the GammaMedplus iX Service and
Maintenance Manual. The service manual includes a section on ServPlus, the
software required for service and testing of the GammaMedplus iX.
Note: Service functions performed using the GammaMedplus iX
control software require service engineer privileges.

The main functions performed by service engineers include:

• System installation
• Annual maintenance and service visits 6
• Source and dummy wire exchange
• System check after disruption of service

Important: You must perform a backup of all control software data files
before your service engineer arrives on site. Refer to the “Back
Up and Restore Files” section in Chapter 4, “System
Configuration” for more information.

Note: For detailed information on emergency response procedures,


refer to Chapter 5“Emergency Procedures”.

In This Chapter

Topic Page
System Installation 6-2
Annual Maintenance and Service Visits 6-2
Source and Dummy Wire Exchange 6-3
System Check After Disruption of Service 6-4

6-1
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System Installation
The installation and initiation of operation of the GammaMedplus iX system
may only be performed by a qualified Varian service engineer according to the
guidelines set forth in the GammaMedplus iX Service and Maintenance
Manual. After the installation, the service engineer checks the entire
GammaMedplus iX system for functionality and safety using a test protocol.

When successful testing of the GammaMedplus iX is complete, the system


may be turned over to you, the customer. At this time, the service engineer
reviews the main components of the system with you, including the safety
features. In addition, the service engineer explains safety checks recommended
before treatment, quality assurance on the system, and yearly maintenance and
source exchange procedures.

Annual Maintenance and Service Visits


According to licensing requirements set forth by the US Nuclear Regulatory
Commission (USNRC) and Agreement States, the GammaMedplus iX must
receive a Preventive Maintenance (PM) at least once a year. In other countries,
consult the local competent authority for local regulations. The PM must be
performed by Varian Medical Systems service engineers licensed by the
USNRC or by those persons trained by Varian and having a radioactive
materials license to do so.

The protocol for the annual maintenance includes such tasks as removing the
source wire, removing the dummy wire, removing and inspecting the source
and dummy drives (replacing them if necessary), checking guide tubes,
checking mechanical limit switches, checking the handcrank, checking the
indexer, checking the chassis, performing a functional test of the control PC,
running the ServPlus test program, testing safety features, performing a
radiation survey, performing a test treatment, checking the independent
radiation monitoring device, measuring the operating voltages, and making a
list of damaged and replaced parts.

Note: There are no user serviceable parts. Please contact your local
Varian service representative in the event of a system failure.

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In addition to preventive maintenance, general service visits may include the


following tasks:

• Verify the current system status by reviewing the error logs, system
parameters and system settings
• Perform system tests to check the system performance prior to
maintenance activities
• Perform higher level maintenance as applicable
• Install a new source wire
• Complete the appropriate radiation surveys
• Calibrate the active source wire position
• Prepare the old source for return shipment
• System handover: source documentation and field service paperwork

6
Source and Dummy Wire Exchange
A new sealed source is recommended every three to four months due to the
half-life of Iridium-192 (about 74 days). The source exchange must be
performed by Varian Medical Systems service engineers licensed by the
USNRC or by those persons trained by Varian and having a radioactive
materials license to do so. Only source wires delivered from Varian Medical
Systems may be used. A new source wire is delivered with a source certificate
that states the source strength (Air Kerma Rate at a reference date) and attests
that the source is leak free.

Note: When performing a leak test, wipe only the surfaces that have
made contact with the source. Such surfaces are the interior
areas of applicators and source guide tubes.

The source exchange proceeds according to work instructions in the service


manual and is documented on the checklist for source exchange. The distal and
stored position of the source wire and the distal position of the dummy wire are
monitored and adjusted. In addition, the safety functions of the
GammaMedplus iX are tested and adjusted.

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The used source wire is returned to the manufacturer along with the certificate
of return. For safety reasons, the maximum duration of use for the source wire
is limited to 5000 cycles.

The control software enables the service engineers to specify or review the
following data about a new source wire: serial number, source strength,
exchange date, maximum number of wire cycles, used number of wire cycles,
and comments.

Dummy Wire Exchange

For safety reasons, the maximum duration of use for the dummy wire is limited
to 7000 cycles or a maximum of 2 years regardless of cycles. In the case of
visible wear, external damage, or kinks, the dummy wire must also be
replaced. Only dummy wires delivered from Varian Medical Systems may be
used. After a dummy wire exchange, the distal position of the dummy wire
must be inspected.

The control software enables the service engineers to specify or review the
following data about a new dummy wire: serial number, exchange date,
maximum number of wire cycles, used number of wire cycles, and comments.

System Check After Disruption of Service


Error conditions that can cause a disruption of service fall into two main
categories — those that affect the source wire or dummy wire guidance, and
those that do not affect the source wire or dummy wire guidance. After any
disruption affecting source wire or dummy wire guidance, the
GammaMedplus iX system needs to be checked by a service engineer. Other
disruptions, such as those affecting the indexer board, the power supply unit,
and the cable connections, also need to be checked by service personnel. In
each case, only an adequately tested device may be given over to the user.
All disruptions are reported back to the manufacturer using the field problem
report.

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Chapter 7 GammaMedplus 3/24 iX System

The GammaMedplus 3/24 iX has all of the safety features, precision,


flexibility, and portability of the GammaMedplus iX, with five channels rather
than the standard 24. A maximum of three channels can be used in one
treatment delivery session. Channels 1–3 are typically used for intracavitary
treatments and allow for the GammaMedplus system’s unique applicator end
test. Channels 23 and 24 are used for intraluminal or other treatments where an
end test check is not desired. The GammaMedplus 3/24 iX is perfectly suited
to meet most routine clinical needs for gynecological, bronchial, lung,
esophageal, bile duct, rectum and single channel breast treatments.

This chapter describes features and procedures that are applicable to the
GammaMedplus 3/24 iX system only. Except in the areas described below, the
GammaMedplus 3/24 iX does not differ in its basic operation and function
from the 24-channel system. These operations and functions are described in
detail in the other chapters in this user guide.

In This Chapter 7
Topic Page
System Description 7-2
The Channel View Strip 7-3
Insertion of the Applicator into the Patient 7-4
Source Guide Tube Connection 7-4
Transporting the 3/24 7-6

7-1
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System Description
The GammaMedplus 3/24 iX remote-controlled afterloader is equipped with
an Iridium-192 (Ir-192) source that is fixed to a stainless steel cable and moved
into an applicator or catheter inserted into the patient. The source can be moved
into 3 of 5 available channels in succession via the indexer head. In each of
these channels, the source may be programmed to stop in up to 60 dwell
positions for individual dwell times of 0.1 to 9999.9 seconds. The applicator in
the patient is connected to the afterloader via one or more source guide tubes.

Note: The GammaMedplus 3/24 iX has channel Nos. 1, 2, 3, 23 and 24


available, which are a subset of the 24 channels in the full featured
GammaMedplus iX afterloader.

Indexer head

Device housing (with


adjustable height)

Chassis

Trailing wheels

Swivel wheels

For a detailed description of the system components, refer to Chapter 1


“Introduction”.

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The Channel View Strip


The Channel View Strip in the control software provides read-only data on the
channels and dwell positions for the fraction about to be delivered. This strip
is always open. The strip contains a table listing each channel in the current
fraction with a graphical representation of each channel, a set of fields
summarizing treatment data for this fraction, and the Previous and Initiate
Treatment buttons.

You can click on a channel to select and highlight it in the Channel View Strip.
After a channel is selected, you can use the Up and Down arrow keys on the
keyboard to move up and down through the channels and select them. The left
and right scroll buttons enable you to scroll horizontally through a channel
when necessary.

User Info Strip

Patient Info Strip

Fraction Info Strip


Channel View Strip

Channel Edit Strip

System Status Strip

Refer to the “View and Edit Channel Data” section in Chapter 2 “Patient and
Treatment Data” for detailed information on the Channel View and Channel
Edit Strips.

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Insertion of the Applicator into the Patient


The GammaMedplus 3/24 iX system supports a full range of intracavitary and
intraluminal applicators. Refer to the Varian BrachyTherapy Applicators and
Accessories Catalogue for a complete list of available applicators and
accessories. Each applicator is shipped with detailed instructions for use,
including assembly, insertion, removal, disassembly, and sterilization of the
applicator set. Be sure to read and follow these instructions carefully.

Note: The GammaMedplus 3/24 iX afterloader has 5 available


channels. A maximum of three channels can be used in one
treatment delivery session. For channels 1-3, the dummy
wire performs a channel end test to verify that the channel
length is the required 130 cm and no longer. For channels 23
and 24, the dummy wire does not push against the end of the
channel during the dummy wire test. In these channels, the
dummy wire only checks to see if the channel length is at
least 130 cm, but not whether it is longer than 130 cm. You
must check the correct length of each channel (source guide
tube + applicator) before the treatment using the appropriate
length gauge.
The bronchial catheter is an example of an applicator that
requires the use of channels 23 and 24. Due to the design of
the applicator, the force of the dummy wire pushing against
the closed end of the catheter during the channel test should
be avoided.

Source Guide Tube Connection

Note: Before you connect the source guide tubes to the indexer head,
use the length gauge to check the correct source guide
tube/applicator probe combination length. Refer to the
instructions for use supplied with the source guide tubes and
applicator for detailed information.

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Connect each source guide tube or applicator to the correct channel of the
indexer head according to the channel number determined in the treatment
planning software. Using slight pressure, insert the coupling of each source
guide tube into the channel opening of the indexer head until the coupling is
engaged.

The source guide tubes must be clean and free of foreign bodies and moisture.
Water vapor, especially on the inside of the tubes, can lead to damage of the
afterloader.

Free passage of the active wire through the source guide tube and applicator 7
may be impeded if a tube that is kinked, crushed, stretched, or damaged in any
other way is used. Source guide tubes should be inspected prior to use, and if
they show any signs of defects, they should be discarded.

Source Guide Tube Support (Accessory)

In some treatment situations, it can be helpful to use the GammaMedplus iX


source guide tube support in order to prevent kinking and reduce stress on the
source guide tubes. It also reduces strain on the applicator(s) and keeps the
patient more comfortable.

GammaMedplus 3/24 iX System 7-5


GM10 UG Book.book Page 6 Tuesday, March 24, 2009 11:22 AM

Refer to the “Prepare the Patient, Afterloader, and Control Software” section
in Chapter 3 “Delivery of Patient Treatment” for more information on setting
up the GammaMedplus iX 3/24 iX system for patient delivery.

Transporting the 3/24


The procedures for preparing the GammaMedplus 3/24 iX for transport are
described in detail in Appendix E “Transporting the GammaMedplus iX”.

7-6 GammaMedplus iX User Guide


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Appendix A System Errors and Messages

This chapter provides a list of critical afterloader and control PC errors and
messages for the GammaMedplus iX. The control software displays error
messages at the bottom of the screen, above the System Status Strip. The
messages are divided into the sections listed in the table below. Refer to the
“Status and Error Messages” section in Chapter 3 “Delivery of Patient
Treatment” for more information on system errors.

WARNING A-1: Always survey the radiation level surrounding the patient
and in the treatment room after a system failure to ensure
that there is no radiation hazard. Failure to do so may result
in serious injury to the operator or patient. If radiation is
detected, proceed with the Emergency Response procedure
as outlined in Chapter 5 “Emergency Procedures”.

In This Chapter

Topic Page
Afterloader Errors and Messages A-2
A
Control Software Errors and Messages A-6

A-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Afterloader Errors and Messages

Table 1-1 Afterloader Errors and Messages

Code Message Cause Response


01 Interrupt MANUAL Interrupt button on the Control Continue the treatment by
Console was pressed pressing the Start button on the
Control Console

02 Interrupt DOOR Door of the treatment room Close door or activate Last Man
opened during treatment Out system

03 Interrupt DOSE External dose measurement unit Correct the error and reset the
has exceeded a set warning dose measurement unit
threshold

04 GammaMedplus disabled GammaMedplus is locked Turn the switch at the afterloader


because of operation of another to enable input (crossover switch)
device

05 No probe connected to Source guide tube in channel xx Check/correct connection


channel [x] improperly connected or not
connected

06 Battery voltage is less Battery voltage too low in order Charge the battery via AC power,
than 20 V to start the treatment check the charge indication; verify
the battery key switch position is
ON

07 Mains voltage is missing Interrupted AC power supply of Check the mains cable
GammaMedplus

09 Probe too long in Total probe length exceeded Check/correct connection


channel [x]

11 Limit switch ESOQ defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

12 Limit switch ESOD defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

13 Limit switch ESUQ defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

14 Limit switch ESRQ defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

15 Limit switch ESRD defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

16 Emergency drive defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

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Table 1-1 Afterloader Errors and Messages

Code Message Cause Response


17 Limit switch ESVD defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

18 Limit switch ESUD defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

19 Dummy drive overcurrent Electrical or mechanical fault Call Varian BrachyTherapy service
in channel [x]

20 ESOD not reached Electrical or mechanical fault Call Varian BrachyTherapy service

21 ESRQ not reached or Electrical or mechanical fault Call Varian BrachyTherapy service
spring defective

22 ESRD not reached Electrical or mechanical fault Call Varian BrachyTherapy service

23 Limit switch ESVQ defec- Electrical or mechanical fault Call Varian BrachyTherapy service
tive

24 Broken dummy Electrical fault or broken tip of Call Varian BrachyTherapy service
the dummy wire

25 Source pushed in Source guide tube kinked, length Place source guide tube without
channel [x] at [y] cm of source guide tube too small kinks, pay attention to correct
length of source guide tubes

50 Incorrect program number Error while transferring the treat- After restarting the system, restart
ment plan the treatment

51 Expected character incor- Error while transferring the treat- After restarting the system, restart
rect ment plan the treatment
A
52 Wrong page number Error while transferring the treat- After restarting the system, restart
ment plan the treatment

53 Transmission test failed Error while transferring the treat- After restarting the system, restart
ment plan the treatment

54 Incorrect instruction code Error while transferring the treat- After restarting the system, restart
ment plan the treatment

55 Incorrect stepsize in Input was > 10 or < 1 Correct the input


channel [x]

56 Incorrect checksum in Error while transferring the treat- After restarting the system, restart
channel [x] ment plan the treatment

57 Incorrect cycle in page 00 Error while transferring the treat- After restarting the system, restart
ment plan the treatment

58 Incorrect factor in page 00 Error while transferring the treat- After restarting the system, restart
ment plan the treatment

System Errors and Messages A-3


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Table 1-1 Afterloader Errors and Messages

Code Message Cause Response


59 Incorrect offset in Error while transferring the treat- After restarting the system, restart
channel [x] ment plan the treatment

0a Inactive source or Dummy instead of source or Call Varian BrachyTherapy service


Geiger-Müller counter electric failure
defective

0b Dummy pushed in Source guide tube kinked, length Place source guide tube without
channel [x] at [y] cm of source guide tube too short kinks, pay attention to correct
length of source guide tube

0c Dummy drive defective Electrical or mechanical fault Call Varian BrachyTherapy service

0d Source drive overcurrent Electrical or mechanical fault Call Varian BrachyTherapy service
in channel [x]

0e Source drive defective Electrical or mechanical fault Call Varian BrachyTherapy service

0f Indexer defective Indexer defective Call Varian BrachyTherapy service

1a/1b Wrong distance measure- Electrical or mechanical fault Call Varian BrachyTherapy service
ment source/dummy

1c Source travel time error Source needs more than 9 sec Call Varian BrachyTherapy service
to reach distal position

1d Dummy travel time error Dummy needs more than 9 sec Call Varian BrachyTherapy service
to reach distal position

1e Key switch head LOCKED SOURCE key on afterloader Turn key switch to RELEASED
keypad in LOCKED position position

1f ESOQ not reached Electrical or mechanical fault Call Varian BrachyTherapy service

5a Fault in real-time clock or Incorrect check sum in the Please recreate the treatment plan
its RAM memory or hardware defect

5b Fault in data transmission Error while transferring the treat- After restarting the system, restart
ment plan the treatment

5c No echo received Interrupted data transfer from After restarting the system, restart
PC to GammaMedplus the treatment

5d Waited too long for recep- Interrupted data transfer from After restarting the system, restart
tion PC to GammaMedplus the treatment

5e Incorrect operation mode Irradiation was executed in the Use new treatment plan
wrong mode (HDR <> PDR)

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Table 1-1 Afterloader Errors and Messages

Code Message Cause Response


5f Battery voltage is less Battery voltage too low in order Charge the battery via AC power,
than 20 Volts to start the treatment check the charge indication; verify
the battery key switch position is
ON

a1 RADIATION After the end of a treatment, Check to see if the source is in the
radiation is detected shielded position and follow the
EMERGENCY RESPONSE
instructions

a2 EMERGENCY MANUAL EMERGENCY RETURN switch After restarting the system, restart
pressed the treatment

a3 EMERGENCY MANUAL Emergency button on after- After restarting the system, restart
FROM TROLLY loader keypad pressed the treatment

a4 TIMING ERROR; no GammaMedplus did not receive Check cable connection between
response from PC. Check a signal as expected from the GammaMedplus and control PC;
all data and power control PC synchronize clocks on Gamma-
connections. Medplus and control PC; verify
that power to the GammaMedplus
is on

a5 ELECTRONICS DEFEC- Electrical or mechanical failure Call Varian BrachyTherapy service


TIVE

a6 CONSOLE DEFECTIVE One or more remote consoles is Call Varian BrachyTherapy service
defective

a7 POWER OFF (Console) Power outage on control PC Switch on control PC and refer to
DURING IRRADIATION during treatment delivery the “Continue Treatment after
Control Software Failure” in
A
Chapter 3

a8 Treatment is aborted by Under certain circumstances, You will be prompted to turn the
control PC command ‘@’ the control software will issue an afterloader off and then on at the
abort treatment command to the key switch. The control software
afterloader will display the treatment recovery
options. Check the Treatment
Delivery Report for the cause of
the error and, if necessary, call
Varian BrachyTherapy service.

c8 Afterloader power outage The afterloader has been turned If necessary, turn the afterloader
detected - check key off at the key switch on.
switch

System Errors and Messages A-5


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Table 1-1 Afterloader Errors and Messages

Code Message Cause Response


e7 Communications time-out Too much time has passed since Ensure that the afterloader is
the control PC has received an turned on. Check all data connec-
update from the afterloader. The tions between the control PC and
control software assumes that the afterloader.
the afterloader cannot communi-
cate with the control PC.

e8 Afterloader has attempted Afterloader firmware or hard- Compare the scaled dwell time
to exceed scaled dwell ware error. against the delivered dwell time for
time by more than one all positions in the Treatment
second Delivery Report and make any
necessary adjustments in the
treatment plan. Call Varian
BrachyTherapy service.

e9 Afterloader has reported Afterloader firmware or hard- Compare the scaled dwell time
dwell complete while one ware error. against the delivered dwell time for
second or more is still all positions in the Treatment
remaining Delivery Report and make any
necessary adjustments in the
treatment plan. Call Varian
BrachyTherapy service.

Control Software Errors and Messages

Table 1-2 Control Software Errors and Messages

Message Cause Response


A file with this name has previ- This message is a warning to avoid Select YES to import the file and NO to
ously been imported. Continue delivering the same treatment twice. cancel the operation.
anyway?

A patient with this ID already This message appears in the Create Refer to the “Create New Patient File
exists in the database. A new New Patient File workflow if you try Workflow” section in Chapter 2
course of treatment will be to create a new patient with a “Patient and Treatment Data” for more
created for this patient. patient ID that matches a patient_ID information.
Continue? already in the database.

Are you sure you want to The Conversion factor, when spec- Select YES to confirm the value you
change the conversion factor? ified in the System units group box of entered. Select NO to verify the value
Remember that this value the System Settings tab, must match and re-enter it.
should equal the one used in the conversion factor used in the
your planning system. treatment planning system.

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Table 1-2 Control Software Errors and Messages

Message Cause Response


Are you sure you want to set This message is a routine confirma- Verify that the new source strength is
the site calibrated source tion message that appears each time correct. Refer to the “Enter the Cali-
strength to [numeric value] the source is calibrated. If you brated Source Strength” section of
[units]? answer YES, it may cause the site Chapter 4 “System Configuration” for
calibrated source strength to vary more information.
from the manufacturer’s, which will
have an effect on the patient treat-
ment.

At least one channel cannot be This message appears when initi- You can delete the channel using the
delivered, because all dwell ating treatment delivery if the sum of Channel Editor and try again, or
times scale to a value less all the dwell times in a given channel generate a new plan via the treatment
than the minimum supported is zero (after scaling). planning system.
by the afterloader.

At least one dwell time was This plan specifies small dwell times Select YES to continue with the current
scaled to a value less than the that are converted to zero when dwell times or NO to cancel the opera-
minimum supported by the scaled to match the current source tion.
afterloader. These values will strength.
be converted to zero.
Continue?

Battery RAM access failed - This message may appear if a Check all connections with the after-
Could not retrieve power fail communication error occurs while loader, including the serial cable on
data. Console reboot recom- the control software is reading power back of the control PC. If necessary,
mended. failure data from the afterloader. reboot the control software.

Cannot load the failing fraction While recovering from a power It is recommended that you answer
[fraction number]. Clear power failure, the control software tries to NO, and call Varian BrachyTherapy A
fail data from the afterloader? determine the fraction number of the service because the message indi-
plan being delivered. If it cannot find cates a possible corruption in the treat-
the corresponding fraction number in ment history file.
the treatment history file for the plan,
this message will result.

Changing the origin will shift all This message appears if you change Select YES if you want to continue or
dwell positions in channel the origin using the Origin field or NO to cancel the operation. Refer to
[channel number]. Do you the Origin button (and IN/OUT the “The Channel Edit Strip” section in
want to change the origin? buttons on the afterloader keypad) in Chapter 2 “Patient and Treatment
the Channel Editor. Data” for more information.

Changing the step size will This message appears if you enter a Refer to the “The Channel Edit Strip”
clear all dwell positions in new Step size in the Channel Edit section in Chapter 2 “Patient and
channel [channel number]. Do Strip. Treatment Data” for more information.
you want to change the step
size?

System Errors and Messages A-7


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Table 1-2 Control Software Errors and Messages

Message Cause Response


Console could not start - This message will appear in a Call Varian BrachyTherapy service
Screen resolution must be at Windows dialog box if the screen
least [x dimension by y dimen- resolution on the control PC is not
sion]. set within specification. This
message should not appear under
normal usage.

Could not reset the error. This message may appear after an After you have been logged off, restart
Treatment will be suspended, unsuccessful restart of the after- the afterloader. Log back into the Open
and you will be logged off. loader following an interruption in Patient File workflow, and you will be
treatment. guided into the Partial Treatment
options.

In certain localities, including If you change the Location on the Recalibrate the source strength. The
the US, regulations require User Login Page, the control soft- control software does not check to
that the afterloader be recali- ware displays this message indi- ensure the recalibration has been
brated when it is moved to a cating that the source strength may completed. For countries other than
new location. Please check need to be recalibrated. If the after- the United States, check the regula-
with your Radiation Safety loader is moved to any location tions set forth by the local Competent
Officer if you are uncertain of outside the facility, the USNRC Authority.
the requirements for your requires that prior to patient treat-
area. ment a full calibration be conducted.
Each time the unit is relocated, it
must undergo full calibration.

Patient [first/last] name does This message appears in the Plan Refer to the “Import a Patient Treat-
not match the corresponding Import Wizard if there is a mismatch ment File” section in Chapter 2 “Patient
value in the database for this in patient first/last name. and Treatment Data” for more informa-
Patient ID. Use this new value tion.
from now on?

The afterloader family-model When the control software boots up, Call Varian BrachyTherapy Technical
is invalid, or the description file it checks the registry. If indetermi- Support
for it could not be found. nate data is returned, this message
Please contact Varian Tech- appears in a Windows dialog box.
nical Support for assistance.
When you click on 'Ok', the
console application will shut
down.

The afterloader is disabled. This message appears if the EMER- Pull the EMERGENCY RETURN
Check the emergency stop GENCY RETURN SWITCH is SWITCH out and press the START
button. pressed down when you try to deliver button.
a treatment.

The afterloader's active wire There is a mismatch in the wire serial Call Varian BrachyTherapy service
does not match the console number, possibly due to swapping of
computer's. the old control PC with a new one.

A-8 GammaMedplus iX User Guide


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Table 1-2 Control Software Errors and Messages

Message Cause Response


The console and afterloader This message may appear when you Set the system time in the System
clocks differ by more than [n] log onto the control software if the Settings tab. Refer to the “Set the
minutes. Please reset the clock times are out of sync. System Date and Time” section in
times via the system settings Chapter 4 “System Configuration” for
tab. more information.

The console application The control software is attempting to Follow the response as designated in
cannot start. There is a serious start up and there is an error or the error message.
problem with the console data- possible corruption in the database.
base (error code nn). Please
call Varian Technical Support.
Press No to attempt a reboot
with the current database.
Press Yes to replace the
current database with an
empty database. If you have a
recent system backup, you
should attempt to restore it
using the Backup & Restore
tab.

The console can not communi- The communications link between Check the cable connections and/or
cate with the afterloader. the control PC and and the after- turn on the afterloader.
loader is defective or detached; or
the afterloader is turned OFF.

The current source strength This message appears if the control Call Varian BrachyTherapy service
exceeds the value allowed for software determines that the source
patient treatment (call Varian). strength exceeds the allowed value.

The entered time is more than This message may appear when you Refer to the “Set the System Date and A
[n] minutes different from the are entering a new system time in Time” section in Chapter 4 “System
current time. This may affect the System Settings tab. Configuration” for more information.
the accuracy of the source
calibration.

The following components are This message indicates that the Call Varian BrachyTherapy service
missing from the current instal- control software cannot find one or
lation: [list of components]. more files necessary for safe opera-
Please contact Varian Tech- tion. The message should never
nical Support for further assis- appear.
tance. When you click on 'Ok',
the console application will
shut down.

System Errors and Messages A-9


GM10 UG Book.book Page 10 Tuesday, March 24, 2009 11:22 AM

Table 1-2 Control Software Errors and Messages

Message Cause Response


The maximum starting dwell This message can appear when Either change the step size or change
position minus the actual creating a new test plan. The first the most distal non-zero dwell position.
starting position must be a non-zero dwell position must be a
multiple of the step size. whole-number of step sizes from the
distal offset. If it’s a fractional
number, this message will result.

The new source strength This message appears if the entered Select YES to continue with the source
differs by more than [n] source strength is 5-10% greater strength as entered. Select NO to enter
percent from the manufac- than the Manufacturer measured a new value.
turer's value. Continue? source strength.

The plan contains dwell This message appears if you make Select YES if you want to save the
changes. Please note that changes to dwell positions or dwell changes to the dwell positions or NO to
these changes only apply to times in the Channel Editor. cancel the operation. Refer to the “The
the current fraction. Do you Channel Edit Strip” section in
want to save these changes? Chapter 2 “Patient and Treatment
Data” for more information.

The source either needs to be When a new source wire is installed, Calibrate the source and enter the new
site calibrated, or the manu- it must be calibrated before you can value in the New site calibrated
facturer measured value use it for a patient treatment. source strength field of the Source
should be confirmed. Strength tab.

The total scaled dwell time for The total dwell time has exceeded Modify the dwell times to within range
the plan is [n] seconds, which 99999.9 seconds. using the Channel Editor or treatment
exceeds the maximum planning system.
allowed [nn].

The treatment history file for This message appears if you select a Call Varian BrachyTherapy technical
this patient could not be found. patient from the Patient Selection support for a recovery procedure.
Do you want to remove this list, and the underlying treatment
record from the database? history file can not be found. It
means that the treatment history file
was deleted or moved without using
the control software. It should not
happen under normal usage circum-
stances.

The wire serial number in the This message could appear if a As the message indicates, cancel the
afterloader has changed since different afterloader is connected to treatment delivery and re-initiate the
the plan was initiated. Please the control PC after a treatment is treatment.
cancel delivery and re-initiate. initiated but before the treatment
delivery begins.

There are not enough This message appears if there are Call Varian BrachyTherapy service to
remaining dummy or active insufficient wire cycles when you install a new dummy or active wire; or
cycles to perform this treat- attempt to initiate a treatment. possibly a new motor drive.
ment.

A-10 GammaMedplus iX User Guide


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Table 1-2 Control Software Errors and Messages

Message Cause Response


This fraction requires [nn] This message may appear if you are In the treatment planning software,
channels, but only [n] may be trying to import a treatment plan for verify that the number of channels
used. an afterloader that supports fewer specified in the plan matches the
channels than the plan specifies. number of channels supported by the
afterloader.

This patient has [n] plans with You have selected a patient in the Use BrachyVision™ to assign a unique
the same Plan ID. To import Plan Import Wizard that has multiple Plan ID to the plan. In the control soft-
this plan, please use your plans with the same Plan ID number. ware, press the Cancel Import or
treatment planning system to You cannot import the selected plan Previous button on the Plans Strip of
give this plan a unique Plan ID. without first assigning a unique plan the Plan Import Wizard and proceed
identifier to the plan. with the plan import process.

Treatment file for the inter- This message can appear if the If you answer YES, the last-treated
rupted plan could not be attached afterloader’s on-board record will be deleted from the after-
found. Reset power failure memory indicates that the last treat- loader. If you answer NO, the record
data? ment was interrupted, but the corre- will be kept on the afterloader – but no
sponding treatment history file does patient treatments will be allowed on
not exist in the control software. the afterloader until the record is
cleared.

Unable to set the source This message appears if you attempt Enter a value in range.
strength. The new site cali- to enter a New site calibrated
brated source strength range source strength that is out of range
is between [n] and [nn]. of the values in parentheses to the
right of the field.

Unable to retrieve patient The communication link between Check the cable connections and the
appointments. ARIA and the control PC is defective communications settings.
or detached. There might be an error
in the communications settings for A
ARIA or the control PC, specifically
in the worklist service settings.

Unable to retrieve plan. The communication link between Check the cable connections and the
ARIA and the control PC is defective communications settings.
or detached. There might be an error
in the communications settings for
ARIA or the control PC, specifically
in the database service settings.

Unable to retrieve patients. The communication link between Check the cable connections and the
ARIA and the control PC is defective communications settings.
or detached. There might be an error
in the communications settings for
ARIA or the control PC, specifically
in the database service settings.

System Errors and Messages A-11


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Table 1-2 Control Software Errors and Messages

Message Cause Response


Unable to update the appoint- The control software is unable to Check the cable connections, the
ment status. Please update update the appointment status due communications settings, and the
manually. to a communications problem, a appointment status.
worklist settings problem, or the fact
that the appointment is already
complete.

Validation Error: File The treatment plan file is corrupted. Recreate the plan in the treatment
checksum is invalid. planning system.

Validation Error: Missing The treatment plan file is corrupted. Recreate the plan in the treatment
end-of-channels indicator. planning system.

Validation Error: Missing The treatment plan file is corrupted. Recreate the plan in the treatment
end-of-file indicator. planning system.

Validation Error: Parse error The treatment plan file is corrupted. Recreate the plan in the treatment
encountered while reading the planning system.
file.

Validation Error: The sum of all This message may appear when Recreate the plan in the treatment
dwell times in channel importing a treatment plan. It indi- planning system.
[number] is declared to be [n], cates a file corruption.
but is actually [nn].

A-12 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Appendix B GammaMedplus iX
Calculations

This appendix contains information about the calculations in the table below.

In This Chapter

Topic Page
Scaled Dwell Time B-2
Source Decay B-3
Transit Dose B-5

B-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Scaled Dwell Time


The control software uses the following formula to convert planned dwell time
to scaled dwell time:

Ts = ( Sp ⁄ Sc ) × Tp

where:

Ts = scaled time
Sp = planned source strength
Sc = current source strength
Tp = planned time

B-2 GammaMedplus iX User Guide


GM10 UG Book.book Page 3 Tuesday, March 24, 2009 11:22 AM

Source Decay
The control software calculates source decay once each day at 12:00 midnight
according to the formula below:

( – λt )
S = So e

where:
S = current source strength
So = known source strength (from
manufacturer)
e = exponential (~2.7183)
λ = (ln 2)/T 1 ⁄ 2 (where T 1 ⁄ 2 = 73.83 days)
t = days since So is known

Refer to the “Enter the Calibrated Source Strength” section in Chapter 4


“System Configuration” for information on modifying the source strength.

The following formula is used to back calculate the Site calibrated source
strength to the date of the Manufacturer measured source strength at 12:00
noon in the local time zone:

( – λt )
So = S ⁄ e

where: B
S = current source strength
So = known source strength (from
manufacturer)
e = exponential (~2.7183)
λ = (ln 2)/T 1 ⁄ 2 (where T 1 ⁄ 2 = 73.83 days)
t = days since So is known

GammaMedplus iX Calculations B-3


GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

Ir-192 Source Decay Table


The following source decay table provides an additional reference for the
decay of the Ir-192 source.

Note: The table is only determined for whole days.

DAYS FACTOR DAYS FACTOR DAYS FACTOR DAYS FACTOR


1 0.9907 34 0.7268 67 0.5332 100 0.3912
2 0.9814 35 0.7200 68 0.5282 101 0.3875
3 0.9722 36 0.7133 69 0.5233 102 0.3839
4 0.9632 37 0.7066 70 0.5184 103 0.3803
5 0.9542 38 0.7000 71 0.5135 104 0.3768
6 0.9452 39 0.6935 72 0.5087 105 0.3732
7 0.9364 40 0.6870 73 0.5040 106 0.3697
8 0.9277 41 0.6806 74 0.4993 107 0.3663
9 0.9190 42 0.6742 75 0.4946 108 0.3629
10 0.9104 43 0.6679 76 0.4900 109 0.3595
11 0.9019 44 0.6617 77 0.4854 110 0.3561
12 0.8935 45 0.6555 78 0.4809 111 0.3528
13 0.8851 46 0.6494 79 0.4764 112 0.3495
14 0.8769 47 0.6433 80 0.4719 113 0.3462
15 0.8687 48 0.6373 81 0.4675 114 0.3430
16 0.8606 49 0.6313 82 0.4632 115 0.3398
17 0.8525 50 0.6254 83 0.4588 116 0.3366
18 0.8445 51 0.6196 84 0.4545 117 0.3335
19 0.8367 52 0.6138 85 0.4503 118 0.3304
20 0.8288 53 0.6081 86 0.4461 119 0.3273
21 0.8211 54 0.6024 87 0.4419 120 0.3242
22 0.8134 55 0.5968 88 0.4378 121 0.3212
23 0.8058 56 0.5912 89 0.4337 122 0.3182
24 0.7983 57 0.5857 90 0.4297 123 0.3152
25 0.7908 58 0.5802 91 0.4256 124 0.3123
26 0.7835 59 0.5748 92 0.4217 125 0.3094
27 0.7761 60 0.5694 93 0.4177 126 0.3065
28 0.7689 61 0.5641 94 0.4138 127 0.3036
29 0.7617 62 0.5588 95 0.4100 128 0.3008
30 0.7546 63 0.5536 96 0.4061 129 0.2980
31 0.7475 64 0.5484 97 0.4023 130 0.2952
32 0.7405 65 0.5433 98 0.3986 131 0.2924
33 0.7336 66 0.5382 99 0.3949 132 0.2897

B-4 GammaMedplus iX User Guide


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Transit Dose
When planning treatments, you may wish to determine the expected transit
dose, and, if necessary, allow for transit dose in dose calculations. This section
describes the transit dose algorithm for the GammaMedplus iX system and
provides specific air kerma measurements for transit absorbed dose.

Transit Dose Algorithm


The GammaMedplus iX system uses 60 dwell positions with a minimum step
size of 1 mm and a maximum step size of 10 mm. The maximum total length
of the irradiation range from the distal position (position 1) to position 60 is
590 mm. The movement of the source is controlled by an integrated motion
control system. When the source moves from one position to the next, it
accelerates to a maximum speed and slows down with a constant deceleration.
The source reaches its maximum speed only when moving a distance greater
than 258 mm. Table B-1 below shows the speed of the source when moving
from position 1 to 60 and from 1 to 10 with a stepsize of 10 mm. The maximum
speed is 630 mm/s.

Table B-1 Source Speed

The irradiation time of a given position starts with the movement from the
previous position to the given position and ends with the start of movement to
the next position. The irradiation during transit to the most distal dwell position
is not considered.

GammaMedplus iX Calculations B-5


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Minimum Dwell Time Restrictions

When using the GammaMedplus iX system, the minimum dwell time that can
be delivered for any given dwell position will vary depending on the distance
between adjacent positions. The minimum dwell time assigned to any given
dwell position must be equal to or greater than the recommended minimum
dwell time listed in Table B-2 below. This table is based on the limited wire
speed between adjacent active dwell positions.

The dwell time for a position begins to elapse when the dwell time for the
previous dwell position reaches zero seconds. With this design, the
GammaMedplus iX system ensures that no additional transit dose is delivered.

Note: Be aware of the fact that in the treatment planning systems,


dwell times are calculated for a “nominal activity”, which is
10 Ci for HDR treatments. The dwell times that are relevant for
the source movement are calculated by applying a decay factor
to the nominal dwell times.
Table B-2 has been established with the minimal dwell times that will allow
correct operation as a function of the distance between two source stopping
positions. Before you start a treatment, you should print out the treatment plan
and check the scaled dwell times with the table of the minimum required dwell
time to reach the next dwell position.

Important: The control software checks all dwell times and distances
between dwell positions when you press the Initiate
Treatment button. Treatment is not allowed if scaled dwell
times at the increments specified in Table B-2 are included in
the treatment plan. Proceed as recommended below.

It is recommended to set dwell times to zero for those positions that do not
fulfill the minimum required dwell time and to add the corresponding nominal
time to the following or previous dwell position to keep the total prescribed
dose constant. You should also change the nominal dwell times in your
treatment planning system accordingly and verify again the dose
distribution before you deliver the treatment. Nominal dwell times are
related to a 10 Ci source strength.

B-6 GammaMedplus iX User Guide


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Table B-2 Minimum Dwell Times Per Step Size

Distance between dwells Recommended minimum


(mm) dwell time (sec)

1-3 0.1

4-13 0.2

14-32 0.3

33-58 0.4

59-92 0.5

93-133 0.6

134-182 0.7

183-238 0.8

239-302 0.9

303-373 1.0

374-452 1.1

453-538 1.2

539-600 1.3

GammaMedplus iX Calculations B-7


GM10 UG Book.book Page 8 Tuesday, March 24, 2009 11:22 AM

Transit Absorbed Dose


Transit absorbed dose is defined as the dose delivered to a point due to the
transit of the radioactive source from the storage container to the treatment
position in the source applicator and the return of the specified radioactive
source to the storage container. Measurements of the transit absorbed dose for
the GammaMedplus iX system are as follows:

• The approximate air kerma at a position 10 mm from the axial center of the
source applicator (assuming an applicator of 100 mm length, a single dwell
position at the distal tip, and a source strength of 10 Ci) is 6.01 mGy.
• The approximate air kerma at a position 1 m from the axial center of the
channel (assuming a channel length of 1.2 m and a source strength of
10 Ci) is 20.52 µGy.

Note: The values above are for informational purposes only and
should not be used for treatment planning.

B-8 GammaMedplus iX User Guide


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Appendix C Afterloader Technical


Description

This chapter includes a technical description of the GammaMedplus iX


system, including information on how the system components are connected.

In This Chapter

Topic Page
Afterloader Description C-2
System Component Connections C-4

C-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Afterloader Description
Pertinent afterloader specifications are referenced in the following chart.

Isotope Ir-192 (HDR), nominal 370 Gbq (10 Ci)


Manufactured according to: ISO1677, ISO2919,
ISO/TR4826, ISO9978
Active length: 3.5 mm
Active diameter: 0.6 mm
Length of capsule: 4.52 mm
Radioactive Diameter of capsule: 0.9 mm
source Diameter of wire: 0.9 mm throughout the whole length
Tolerances
Source positioning: 0.35% (referring to 60 position/Stepsize 10 mm)
Source movement times: 1‰ sec
Air Kerma:
20 mm from applicator’s center axis: max. 17 mGy (typical 20 cm applicator)
1 m from channel’s center axis: 0.045 mGy

Device Manufactured according to: IEC 601-2-17

Adjustable height position: 900 - 1300 mm


Shielding material: Tungsten
Max. source strength: 555 GBq (15 Ci)
Radiation leakage at 1 m: L 2 µSv/h (10 Ci)
Indexer head Number of channels: 24
Number of dwell positions: 60 per channel
Source extension length: max. 1300 mm
Stepsize: 1 - 10 mm

MAINS power supply: 100/115/230 V, 50 - 60 Hz, 100 VA


Supply voltage selectable by factory setting only
Dimensions: 600 mm long, 550 mm wide, 1100 mm deep
Weight: approx. 130 kg
Interface RS 422 (Junction Box),
GammaMed
max. connection length 50 m
chassis Protection classification: IP 40
Protection class: I
Class of application type: B
MAINS fuses: 100/115 VAC: F1,F2 = T1AH250V
230 VAC: F1,F2 = T0,5AH250V

Power supply: 24 V from travelling gear


Power input: 0.15 A
Control
Communications: RS 485 (Junction Box),
console max. connection length 50 m
Protection classification: IP 40

C-2 GammaMedplus iX User Guide


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Electric power supply: 24 V from travelling gear


Power input: 0.1 A (without connected console)
Communications: RS 232 (PC)
max. connection length 15 m,
RS 422 (chassis)
max. connection length 50 m
Junction box Door interlock: contact input
max. connection length 50 m
EMERGENCY RETURN switch: contact input
max. connection length 50 m
Disabled: contact input
max. connection length 50 m
External radiation warning lamp: contact output, 24 V, 0.5 A, AC and DC

Environmental Temperature: 15°C - 35°C


Relative humidity: 30% - 75%
conditions Air pressure: 70 kPa - 110 kPa

Afterloader Technical Description C-3


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System Component Connections


The installation and connection of all GammaMedplus iX system components
is performed by Varian Medical Systems service engineers. A suitable facility
must be provided by the customer. The treatment room and door must be
shielded sufficiently to meet USNRC, Agreement State, or other Competent
Authority regulations.

WARNING C-1: Do not connect any items that are not specified as part of the
system. Doing so may put the system in an unsafe condition.

The required or optional room safety equipment must be installed by qualified


personnel (viewing equipment, door contact, RADIATION warning light,
EMERGENCY RETURN switch, radiation room monitor, intercom, etc.)

Note: Further requirements for the treatment room must correspond to


the general standard for medical treatment rooms.

Power supply circuits and wiring pathways must be provided by the customer
in accordance with the GammaMedplus iX specifications and local electrical
requirements. The necessary component connections of the
GammaMedplus iX system are made by Varian Medical Systems service
engineers at installation. In case of failure, or later structural alterations, the
connections must meet the requirements of the circuit diagram.

WARNING C-2: All electrical connection and disconnection of


GammaMedplus iX equipment is to be performed by Varian
service personnel only.

C-4 GammaMedplus iX User Guide


GM10 UG Book.book Page 5 Tuesday, March 24, 2009 11:22 AM

EMERGENCY RETURN
Door
Last Man Out Switch Switch
Interlock
Junction Control Control PC Printer
GammaMedplus iX box Console and monitor

STRAHLENQUELLE BESTRAHLUNG

STRAHL-
STELLUNG START
GESTARTET

RUHE- BEENDET
STELLUNG
UNTER-
BRE-
VER- CHUNG UNTERBROCHEN
RIEGELT

BETRIEBSART ALARM

NORMAL
SPEZIAL
ALARM T R

EIN / AUS
DOSIS
NETZ HUPE
AUS
BATTERIE HUPE AUS

STEUERPULT

Optional
EMERGENCY RETURN B4
Switch

B0

B3 B2
B1
C0
C1
D0
D1

Treatment room Control room

Optional Safety Systems

B0 Radiation Monitor - Basic device C0 Intercom basic device


B1 Radiation Monitor - Detector C1 Intercom extension
B2 Radiation Monitor - Signal lamp
B3 Radiation Monitor - Triple Indicator/horn D0 Video monitor
B4 Radiation Monitor - Door contact D1 Video camera
C

CAUTION: Disconnect the main AC power, before connecting any


additional components.

Afterloader Technical Description C-5


GM10 UG Book.book Page 6 Tuesday, March 24, 2009 11:22 AM

C-6 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Appendix D Safety Information and Tests

The GammaMedplus iX system is equipped with multiple independent safety


and alarm functions, which, in case of handling error or malfunction, reduce
the possibility of uncontrolled radiation exposure. This chapter reviews safety
information and provides recommendations on tests and checks you can
perform on a routine basis. Refer to the “Important Safety Information” section
in Chapter 1 for more safety information.

In This Chapter

Topic Page
Additional Safety Information D-2
Treatment Day Tests and Checks D-4
Cleaning the Device D-11
Emergency Response Procedures (for posting) D-12

D-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Additional Safety Information

IEC Requirements

Note: Although this system has been tested to the EMC requirements
of EN60601-1-2:2001 and complies with this standard, it may
still be susceptible to electromagnetic interference or generate
electromagnetic interference. Medical electrical equipment
needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information
provided in the installation documents.

The following safety information is noted in conjunction with requirements of


IEC 60601-2-17.

• The GammaMedplus iX and its components require special precautions


regarding EMC and need to be installed and put into service according to
this user manual and the GammaMedplus iX service manual.
• Portable and mobile RF communications equipment can affect the
GammaMedplus iX.
• The GammaMedplus iX is specified and intended for use only in a
treatment room with restricted access.
• In the interest of safety, when entering the room, the door should be left
open. In addition to other safety features, this ensures that no treatments
can be accidentally initiated with personnel in the room.
• The GammaMedplus iX is designed to use and shield an Iridium-192
source with a maximum source strength of 15 Ci (555 GBq). Local
regulations may modify this source strength to a value less than 15 Ci.
• The air kerma rate at any position 50 mm from the surface of the
GammaMedplus iX shall be no greater than 0.1 mGy/h, where
measurements are averaged over an area not exceeding 10 cm2.
• The air kerma rate at any position 1 m from the surface of the
GammaMedplus iX shall be no greater than 0.01 mGy/h, where
measurements are averaged over an area not exceeding 100 cm2.

D-2 GammaMedplus iX User Guide


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• Radioactive sources and source applicators for this equipment must only
be obtained from Varian Medical Systems. It is not permissible to use
radioactive sources from any other supplier. Active wire removal and
loading must only be performed by Varian Medical Systems service
engineers or by those persons authorized by Varian and having a
radioactive materials license to do so.
• The nominal transit speed of the active wire is up to 630 mm/sec,
depending on the travel distance. However, the speed is allowed to fall
while overcoming a path constriction. Inability to overcome the
constriction will cause an automatic retraction of the source.
• Users must be aware that the requirements of the safety standard IEC
60601-2-17 cannot guarantee that the presence of a radioactive source
outside the storage container of the GammaMedplus iX will be indicated
under all fault conditions. The use of an independent radiation monitor in
the same room as the patient is recommended. This independent radiation
monitor should be capable of giving both a visual and audible indication
of radiation, and should be able to continue to function and give an
indication of radiation for several hours after a power failure, for example
by battery back-up. Consult the regulations set forth by the Competent
Authority in your area.
• The positional accuracy of the active wire relative to the distal position is
calibrated to +/- 1 mm. Provided that the catheter connections are secure,
the length of the catheter is accurately measured and the catheter is not
subsequently stretched, the system will achieve a positional accuracy of
+/- 1.5 mm in any direction relative to the target within the applicator.
• Only cables and components supplied by Varian should be used in order to
comply with the requirements of IEC 60601-1-2:2001 36.201
(Electromagnetic Compatibility Emissions) and IEC 60601-1-2:2001
36.202 (Electromagnetic Compatibility Immunity Test). Detailed cable
information is provided in the service manual.
• The use of cables and equipment other than those specified, with the
exception of cables supplied by Varian Medical Systems as replacement
parts for internal components, may result in increased emissions or D
decreased immunity of the equipment.
• The maximum lengths of cables are:
RS232 PC to junction box, maximum connection length is 15 m
RS422 junction box to afterloader, maximum connection length is 50 m
RS485 control console to junction box, maximum connection length is 5 m

Safety Information and Tests D-3


GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

Door input contact at junction box, maximum connection length is 50 m


Dose input contact at junction box, maximum connection length is 50 m
Enable input contact at junction box, maximum connection length is 50 m
• The GammaMedplus iX and its components should not be used adjacent
to or stacked with other equipment. If adjacent or stacked use is necessary,
the GammaMedplus iX should be observed to verify normal operation in
the configuration in which it will be used.
• The GammaMedplus iX is intended for use in the electromagnetic
environment specified such that for RF emissions, it complies with CISPR
11 Type 1 - Class A. The customer or the user of the GammaMedplus iX
should assure that it is used in such an environment.
• The GammaMedplus iX is supplied with a UPS that supplies all system
components. The UPS contains outlets for the control PC, the console box,
the monitor, and the afterloader. As such, there is no requirement for a
multiple portable socket outlet, or a specification for a maximum load for
or risks associated with this outlet.
• Items that are not specified as part of the system shall not be connected to
the system.
• Non-medical electrical equipment which has been supplied as part of the
system shall have suitable office equipment rating and be IEC 60950
compliant.

Treatment Day Tests and Checks


This section describes recommended tests and checks you should perform each
day the GammaMedplus iX system is to be used for patient treatment. Routine
checks are essential to maintain the safety and reliability of the system. Refer
to the “Create and Deliver Physics Test Plans” section in Chapter 4 “System
Configuration” for detailed information on creating a test plan in the control
software. Perform physics tests according to the protocol at your facility. Refer
to Chapter 5 “Emergency Procedures” for information on how to resume a test
treatment after interruption.

D-4 GammaMedplus iX User Guide


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WARNING D-1: All tests involving the extension of the active source wire
must only be performed while no person is in the treatment
room.

Interruption of Treatment
Press the INTERRUPT button on the Control Console during the test
treatment.

Check for the following:

• Room radiation warning light is off

Indications on the Control Console:

• Audible warning signal can be heard


• RADIATION light is off
• SOURCE OUT indicator is off
• SOURCE SAFE indicator is on
• STARTED indicator is flashing
D
• INTERRUPTED indicator is on

Safety Information and Tests D-5


GM10 UG Book.book Page 6 Tuesday, March 24, 2009 11:22 AM

Error message on the control PC:


• WARNING: Interrupt MANUAL

Refer to the “Partial Treatment Strip” section in Chapter 3 “Delivery of Patient


Treatment” for details on how to restart the system.

EMERGENCY RETURN Switch


Press the EMERGENCY RETURN switch inside the control room near the
Control Console during the test treatment.

EMERGEN

CY
RE
TURN

The treatment is interrupted immediately, and the source retracts into its
shielded position.

Check for the following:

• Room radiation warning light is off


Indications on the Control Console:

• ALARM indicator is flashing


• Audible warning signal can be heard on the Control Console and control
PC
• RADIATION indicator is off
• SOURCE OUT indicator is off
• SOURCE SAFE indicator is on
• STARTED indicator is a steady green

D-6 GammaMedplus iX User Guide


GM10 UG Book.book Page 7 Tuesday, March 24, 2009 11:22 AM

Error message on the control PC:


• WARNING: EMERGENCY MANUAL

Refer to the “Restart After Pressing the EMERGENCY RETURN Switch”


section in Chapter 5 “Emergency Procedures” for details on how to restart the
system.

Door Interlock

Before Test Treatment

With the GammaMedplus iX system idle (i.e., not carrying out a treatment),
open the treatment room door. If the afterloader is switched on, the Last Man
Out system is enabled. The door indicator light is supported as long as the
afterloader is powered on.

During Test Treatment

Open the door to the treatment room during the test treatment. The treatment
should be interrupted automatically and the source should retract into the
shielded position.

ALA
ARM
ALARM

ALARM DOOR
RESET

DOSE D
BUZZER
OFF BUZZER OFF

Safety Information and Tests D-7


GM10 UG Book.book Page 8 Tuesday, March 24, 2009 11:22 AM

Check for the following:

• Room radiation warning light is off

Indications on the Control Console:

• Audible warning signal can be heard


• DOOR indicator is on
• INTERRUPTED indicator is on
• RADIATION indicator is off
• SOURCE OUT indicator is off
• SOURCE SAFE indicator is on

Error message on the control PC:


• WARNING: Interrupt DOOR

Power and Power Failure


Connect the power supply to all components of the GammaMedplus iX system
(PC, printer, etc.) by operating the main switch or the individual switches of all
components. The respective indicator lights of the devices should illuminate.

During a test treatment, switch off the power to the GammaMedplus iX by


switching off the UPS (Uninterruptible Power Supply). The battery-powered
emergency retract motor should start and retract the active source wire into the
shielded position. Then return power to the system by switching on the UPS.

WARNING D-2: The GammaMedplus iX must be connected permanently to


main AC power supply even when not in operation.

D-8 GammaMedplus iX User Guide


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Key Tests

POWER Key Switch

When you switch the system on by turning the POWER key to the horizontal
position, the GammaMedplus iX automatically performs an indicator test in
which all indicator lights on the Control Console (and any other external
consoles) flash briefly, and at the same time an audible signal is generated.
When the indicator test is complete, several indicator lights remain lit on the
Control Console — the MAINS and BATTERY indicators in the POWER
section, the NORMAL indicator in the MODE section, and the SAFE
indicator in the SOURCE section. In addition, the LOCKED indicator in the
SOURCE section of the Control Console and afterloader keypad flashes if the
SOURCE key in the afterloader keypad is in the LOCKED position.

POWE

D
SOURCE Key Switch

With the SOURCE key switch in the LOCKED position, attempt to initiate a
treatment. Verify that you cannot start the test treatment with the key in this
position.

Safety Information and Tests D-9


GM10 UG Book.book Page 10 Tuesday, March 24, 2009 11:22 AM

Room Radiation Monitor


An independent radiation monitoring system with visual and audible output is
required in the treatment room. This monitor indicates radiation when the
source is extended. Test for proper operation of the room radiation monitor and
any associated remote unit. The monitor, or the remote unit, must be visible
from the treatment room.

Note: The room radiation monitor is not part of the supply by Varian
unless specifically ordered. See the manufacturer’s instructions
for these devices.

Afterloader Radiation Monitor


The radiation monitor of the GammaMedplus iX is working as long as the
afterloader is switched on. All connected consoles, including the afterloader
keypad, show the radiation signal if the monitor detects radiation.

Source Guide Tube Misconnection


Insert a source guide tube incorrectly into the indexer head. Check that the test
treatment is inhibited.

Viewing and Intercom Systems


Assure the correct operation of the viewing equipment and intercom. Check
that two-way conversation is possible between the treatment room and the
control area.

Note: The viewing equipment and intercom are not part of the supply
by Varian unless specifically ordered. See the manufacturer’s
instructions for these devices.

D-10 GammaMedplus iX User Guide


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Cleaning the Device


Clean the GammaMedplus iX as necessary, but at least every day it is used for
treatment. Clean the surface of the GammaMedplus iX using only a damp
cloth. The plastic membranes on the afterloader keypad and consoles can be
wiped with the disinfectant Cidex by the Johnson & Johnson company.

WARNING D-3: The GammaMedplus iX must be protected against


penetration of liquids while cleaning it.

Safety Information and Tests D-11


GM10 UG Book.book Page 12 Tuesday, March 24, 2009 11:22 AM

Emergency Response Procedures (for posting)


The following sections describe Figure D-1 Emergency Response Procedures
in text format, beginning with the first emergency procedure listed in the
flowchart.

Note: The graphics, cautions, and warnings have been deliberately


removed from the text in Chapter 5, “Emergency Procedures”
to make the text more concise for posting. It is intended that you
use the text in this section as a companion piece to the
information in Chapter 5.

Press the Interrupt Button or Emergency Return Switch


In case of an emergency situation, such as one that requires immediate entry
into the treatment room, do one of the following:

• Press the INTERRUPT button on the Control Console to retract the


source at normal speed or
• Press the EMERGENCY RETURN switch in the control room to retract
the source at maximum speed.

Press the Emergency Button


If the source wire does not retract into the shielded position after pressing the
INTERRUPT button or the EMERGENCY RETURN switch, enter the
treatment room with a portable survey meter and press the EMERGENCY
button on the keypad of the GammaMedplus iX.

When you press the EMERGENCY button on the afterloader keypad, the
GammaMedplus iX does the following:

• Terminates external power


• Shuts down all console indicators and indicator lights
• Initiates emergency battery power that is exclusively directed to the source
drive to retract the source wire into the safe, shielded position

D-12 GammaMedplus iX User Guide


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WARNING D-4: When you press the EMERGENCY button on the afterloader
keypad, the external power supply of the GammaMedplus iX
is switched off, and the source is retracted at maximum speed.
After that, all remote monitors, including the Control Console
and onboard radiation monitoring, are also turned off. The
only indication whether the source is in the shielded position
is the independent radiation monitoring system installed in the
treatment room and your portable survey meter. Confirm that
radiation levels are at background level. If not, initiate the next
step of the emergency response procedures as described in
Figure D-1.
Failure to follow these procedures may result in the following:

• Source may still be in the patient and you will not be aware
of this.

• Source may be outside the shielded position and will


expose the operator and patient to high levels of external
radiation.

Perform Emergency Retraction with Emergency Handcrank

Note: Remember that when you press the EMERGENCY button on


the afterloader keypad, all indicators and indicator lights are
disabled. Radiation detection is provided only by the
independent radiation monitoring equipment.

In the unlikely event that emergency retraction of the source does not occur
after pressing the INTERRUPT button, the EMERGENCY RETURN
switch, or the EMERGENCY button, the source can be retracted manually
into the shielded position using the handcrank.
D

Safety Information and Tests D-13


GM10 UG Book.book Page 14 Tuesday, March 24, 2009 11:22 AM

Follow these steps to manually retract the source using the handcrank:

1. Enter the treatment room with a portable survey meter and go straight to
the GammaMedplus iX.
2. Pull the handle out of the handcrank and turn the crank in the direction of
the arrow until a distinct resistance is noticeable and the room radiation
level is safe.

Note: If the source wire has been retracted and the radiation level is
still high or if manual retraction of the source is not possible
using the handcrank, follow the procedures in the “Perform
Manual Recovery of the Source” section below. These
procedures are also outlined in Figure D-1.

Perform Manual Recovery of the Source


In the unlikely event that you are unable to perform motor-driven emergency
retraction of the source or emergency retraction using the emergency
handcrank, manual recovery of the source is required immediately. If the
source cannot be retracted with the handcrank, the wire may be kinked or there
might be a mechanical malfunction of the source drive mechanism. If the wire
was retracted but the radiation level is still high, the source might be severed
from the wire.

Remove the Applicator from the Patient


If you can easily remove the applicator from the patient, follow the steps
below. Otherwise, continue to the next section.

1. Enter the treatment room with a portable survey meter and personal
dosimeter.
2. Calm the patient.
3. Open the Emergency Container.
4. Remove the applicator carefully from the patient using the long handled
forceps whenever possible. Maintain the maximum possible distance from
the patient and the afterloader.

D-14 GammaMedplus iX User Guide


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5. If possible, place the applicator in the Emergency Container, being careful


not to damage or kink the source guide tube.
6. Move the patient to the room entrance and monitor the patient’s radiation
levels.
7. If there is no indication that the source is still in the patient, remove
him/her from the treatment room. Monitor the patient’s radiation levels.
8. If the radiation levels are at background level, close and lock the door to
the treatment room and place a warning sign on the door indicating that the
source is exposed.

Pull the Source Wire from the Applicator


If you cannot easily remove the applicator from the patient, follow the steps
below:

1. Open the Emergency Container.


2. Disconnect all connectors from the indexer head.
3. Pull the afterloader away from the patient until the wire is visible at the
indexer.
4. Using the forceps or pliers, grab the wire and pull it to remove it
completely from the applicator and/or source guide tube.
5. Immediately place the active tip of the source wire in the Emergency
Container.
6. Move the patient to the room entrance and monitor the patient’s radiation
levels.
7. If the patient survey confirms the source is no longer in the patient, secure
the door to the treatment room and contact the radiation safety officer
immediately.
8. If the patient survey indicates the source is still in the patient, return the
patient to the treatment room and remove any applicators (if still present). D
9. After removal of the applicator, monitor the patient’s dose levels to ensure
the source is no longer in the patient.
10. If the levels indicate the source is still in the patient, emergency surgical
recovery of the source will be necessary.

Safety Information and Tests D-15


GM10 UG Book.book Page 16 Tuesday, March 24, 2009 11:22 AM

Source Press INTERRUPT button or EMERGENCY


EMERGENCY RETURN
Source wire retracted into the afterloader

retracted RETURN
switch. SWITCH
If source still
not retracted
EMERGENCY
button
Enter treatment room DUMMY-
CHANGE

with survey meter.


DUMMY-
WECHSE
L

Source Press EMERGENCY button


retracted on the afterloader keypad. Handcrank

If source still
not retracted

Turn Emergency Handcrank


Source until resistance noticeable or
retracted radiation level safe.

If source still
not retracted

Can applicator be 1. Disconnect all connectors


removed easily? No from the Indexer.
2. Pull the afterloader away
from the patient until the wire
Yes is visible at the Indexer.
3. Using the forceps or pliers,
grab the wire and pull it to
Remove the applicator from remove it completely from
the patient and, if possible, the applicator / catheter.
place it in the emergency 4. Place the active end of the
container source wire in the
Emergency Container.

Immediately move patient to the room entrance and monitor

Are dose rates on patient at background level?


YES NO

Monitor all other areas, Return patient to room.


close and lock the If not already done,
door. remove applicators. If
patient levels still
remain above back-
Emergency ground, emergency
Container surgical recovery will
Call Varian Medical be necessary.
Systems.

Emergency retraction under machine or manual power If the source is stuck in


the patient, it must be
Manual recovery of the source removed surgically as
quickly as possible and
Patient monitoring stored in an emergency
container.
Intervention to remove source

Figure D-1 Emergency Response Procedures

D-16 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Appendix E Transporting the


GammaMedplus iX

This chapter describes the steps required to prepare the GammaMedplus iX for
transport. Note that the steps are the same for the GammaMedplus iX and the
GammaMedplus 3/24 iX systems.

Note: If the afterloader is moved to any location outside the facility,


the USNRC requires that prior to patient treatment a full
calibration be conducted. Each time the unit is relocated, it must
undergo full calibration. The control software does not check to
ensure the recalibration has been completed. For countries other
than the United States, check the regulations set forth by the
local Competent Authority.

In This Chapter

Topic Page
Preparing the GammaMedplus iX for Transport E-2
Inserting the Source Locking Wire E-3
Moving the GammaMedplus iX E-5

E-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Preparing the GammaMedplus iX for Transport


In advance, turn off the POWER key switch on the Control Console and
remove all catheter and source guide tubes from the indexer head.

WARNING E-1: The person moving the GammaMedplus iX loaded with a


radioactive source should be equipped with an independent
radiation warning device and know how to operate it
properly.

With the power off, uncouple the data cable and the mains cable from the
GammaMedplus iX and coil the cables around the rear cable take-up stand of
the device.

Turn the battery main switch to the OFF position to interrupt the battery
supply. Otherwise you will hear a warning signal. Remove the key to the
battery switch. During transport, the battery supply of the GammaMedplus iX
must be switched off to prevent any extension of the source in case of an
accident. The correct position of the source in the shielded position usually
ensured by the battery is now effected mechanically by inserting the source
locking wire.

E-2 GammaMedplus iX User Guide


GM10 UG Book.book Page 3 Tuesday, March 24, 2009 11:22 AM

Inserting the Source Locking Wire


1. Insert the guide for source exchange into Channel 1 and hold it by hand
during the following insertion procedure.

Guide for source exchange

2. Then insert the source locking wire into the channel far enough that about
5-10 cm remains outside.

Connector

Wire

Source locking wire

3. Remove the guide for source exchange.


4. Push the remaining wire into the channel until the connector engages into
the indexer socket with a clearly audible click.

Transporting the GammaMedplus iX E-3


GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

The pictures below correspond to steps 1-4 above.

2 23 24 2 23 24
21 2 21 2
20 20
19 19
2 2
18 18
3 17 3
17
16 4 16 4

5 5

6 6
13 13
7 12 7
12 8
11 1 8 11 1 9
0 9 0

1. 2.

23 24 2 23 24
2
21 2 21 2
20 20
19 19
2 2
18 18
3 17 3
17
16 4 16 4

5 5

6 6
13 13
7 12 7
12 11 1 8
11 1 8 0 9
0 9

3. 4.

WARNING E-2: If the GammaMedplus iX is to be moved across a door


threshold that causes the unit to exit the treatment room, the
source locking wire shall be inserted. Failure to insert the
source locking wire increases the risk of the source wire
becoming dislodged in a public area in the event of an
accident.

E-4 GammaMedplus iX User Guide


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Moving the GammaMedplus iX


You are only allowed to move the GammaMedplus iX loaded with a
radioactive source if the battery is switched off and the source has been secured
by the source locking wire.

Important: Observe local regulations regarding the transport of dangerous


goods when transporting the device outside of the hospital area.

Documents for Transporting the GammaMedplus iX

The GammaMedplus iX must be transported in accordance with all applicable


regulations and guidance. The regulations and guidance include requirements
for packaging, labelling, marking, documentation, and vehicle driver
certification. You must ensure that each of these regulations is satisfied before
the unit is transported.

Transporting the GammaMedplus iX E-5


GM10 UG Book.book Page 6 Tuesday, March 24, 2009 11:22 AM

E-6 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Appendix F MammoSource™ iX Model

The MammoSource iX is an 11-channel system with all of the safety features,


precision, flexibility, and portability of the standard GammaMedplus iX
system. A maximum of eleven channels can be used in one treatment delivery
session. Channels 1–11 are typically used for intracavitary treatments and
allow for the GammaMedplus system’s unique applicator end test. Channels
23 and 24 are used for intraluminal or other treatments where an end test check
is not desired. This model is ideally suited for breast applications using single
or multi-channel breast applicators. In addition it may also be used for
gynecological, bronchial, lung, esophageal, bile duct, and rectum treatments.

This chapter describes features and procedures that are applicable to the
MammoSource iX model. Except in the areas described below, the
MammoSource iX does not differ in its basic operation and function from the
24-channel GammaMedplus iX system. These operations and functions are
described in detail in the other chapters in this user guide.

In This Chapter

Topic Page
System Description F-2
The Channel View Strip F-2
Insertion of the Applicator into the Patient F-3

F-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

System Description
The MammoSource iX is configured so that the source can be moved into 11
of 13 available channels in succession via the indexer head. In each of these
channels, the source may be programmed to stop in up to 60 dwell positions
for individual dwell times of 0.1 to 9999.9 seconds. The applicator in the
patient is connected to the afterloader via one or more source guide tubes.

Note: The MammoSource iX has channel Nos. 1-11 and 23-24 available,
which are a subset of the 24 channels in the full featured
GammaMedplus iX afterloader.

For a detailed description of the system components, refer to Chapter 1


“Introduction”.

The Channel View Strip


The Channel View Strip in the control software provides read-only data on the
channels and dwell positions for the fraction about to be delivered. This strip
is always open. The strip contains a table listing each channel in the current
fraction with a graphical representation of each channel, a set of fields
summarizing treatment data for this fraction, and the Previous and Initiate
Treatment buttons.
You can click on a channel to select and highlight it in the Channel View Strip.
After a channel is selected, you can use the Up and Down arrow keys on the
keyboard to move up and down through the channels and select them. The left
and right scroll buttons enable you to scroll horizontally through a channel
when necessary.

Refer to the “View and Edit Channel Data” section in Chapter 2 “Patient and
Treatment Data” for detailed information on the Channel View and Channel
Edit Strips.

F-2 GammaMedplus iX User Guide


GM10 UG Book.book Page 3 Tuesday, March 24, 2009 11:22 AM

Insertion of the Applicator into the Patient


The 8-channel configuration supports a full range of intracavitary and
intraluminal applicators. Refer to the Varian BrachyTherapy Applicators and
Accessories Catalogue for a complete list of available applicators and
accessories. Each applicator is shipped with detailed instructions for use,
including assembly, insertion, removal, disassembly, and sterilization of the
applicator set. Be sure to read and follow these instructions carefully.

Note: The MammoSource iX has thirteen available channels. A


maximum of eleven channels can be used in one treatment
delivery session. For channels 1-11, the dummy wire
performs a channel end test to verify that the channel length
is the required 130 cm and no longer. For channels 23 and 24,
the dummy wire does not push against the end of the channel
during the dummy wire test. In these channels, the dummy
wire only checks to see if the channel length is at least
130 cm, but not whether it is longer than 130 cm. You must
check the correct length of each channel (source guide tube +
applicator) before the treatment using the appropriate length
gauge.
The bronchial catheter is an example of an applicator that
requires the use of channels 23 and 24. Due to the design of
the applicator, the force of the dummy wire pushing against
the closed end of the catheter during the channel test should
be avoided.

MammoSource™ iX Model F-3


GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

F-4 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Glossary
Access Privileges Permissions to use particular features of the control
software. Privileges are granted by an administrator at
the group level, such that all members of a group have
the same access privileges.
Active Wire The wire that contains the high activity Iridium-192
source.
Applicator Any closed ended delivery system through which the
source wire is intended to pass.
Catheter A flexible form of applicator.
Customer Purchaser of the Varian afterloader system. In the
case of the transportable system, the customer will
have multiple treatment locations to which the system
is transported and used.
Dummy Wire In addition to the active wire, the GammaMedplus iX
is equipped with a second, inactive wire. This dummy
wire serves to check the free passage and overall
length of the source guide tube/applicator assembly of
130 cm.
Dwell Location A position along an applicator channel where the
active wire will be placed and remain for a certain
amount of dwell time.
Dwell Time Amount of time the active wire will remain at one
dwell location before being moved to the next dwell
location or retracted into the safe.
Fraction A set of one or more channel plans to be executed in
a single treatment session.
Group Named sets of users with the same access privileges
for each member. The system defaults to having 4
groups (administrators, oncologists, physicists, and
radiation therapists) plus a special service group for
use only by Varian field service personnel.
Inactive Wire See dummy wire.
F

Glossary-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Partial Fraction A subset of channel plans derived from an original


full fraction, normally resulting from a treatment
interruption. The control software will internally note
where in the fraction/channel plan the interruption
occurred and allow the operator to either skip the
undelivered part or resume at the point of interruption
at a later date.
Partial Treatment An automatic or manual cessation of treatment,
whereby the active wire is physically retracted into
the afterloader's safe while in the middle of delivering
a channel plan of a particular fraction. The treatment
session may or may not be terminated as a result.
QA Check A procedure performed regularly by clinical
end-users to ensure that the afterloader is functioning
properly. Checks can be performed daily, weekly, on
the day of a treatment, or at some other clinic-defined
interval.
QA Protocol A set of QA checks.
Source Wire See active wire.
Treatment Course A set of one or more treatment plans, each of which is
not necessarily identical to the other, that is required
to fulfill a prescription.
Treatment Location A specific location where a Varian afterloader system
can be used by a particular customer. There is at least
one treatment location for a customer. Owners of the
transportable system may have multiple treatment
locations defined. Certain configuration information
applies to all locations for a customer, and other
information can be configured on a per-location basis.
Treatment Plan A treatment plan for a particular patient consists of:

1. Plan setup (geometrical part, dwell positions, dwell


times, etc.)

2. Fractionation (number of fractions)


3. Dose prescription

Glossary-2 GammaMedplus iX User Guide


GM10 UG Book.book Page 3 Tuesday, March 24, 2009 11:22 AM

In the context of the Varian afterloader system, a


treatment plan further contains the complete history of
all changes and execution attempts for that plan,
including partial and redistributed fractions, as the
plan is delivered to the patient.
Treatment Site The anatomical target for treatment.
User Named individuals that can use the afterloader
system. All users are defined by the administrator to
belong to one and only one group. Access privileges
are granted at the group level only. Note that control
software users are completely separate from operating
system users.

Glossary-3
GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

Glossary-4 GammaMedplus iX User Guide


GM10 UG Book.book Page 1 Tuesday, March 24, 2009 11:22 AM

Index

A Applicators button 4-28


Abort this fraction options 3-34 ARIA Communication Settings 4-33, 4-36
Absolute value dwell times check box 4-40, ARIA database 2-4, 2-6, 2-9, 3-31
4-43 At exchange field 4-50
Activation Status 2-13 At treatment field 4-50
Active field 3-23 Atmosphere 1-10
Active record 2-13 Audible signal 1-22
Active treatment records database 2-5, 2-10, Authorized user 1-2, 1-4
2-11, 2-12 Automatic backup on check box 4-31
Active wire 3-20, 3-25 Automatic backup system files group box
Active wires table 4-49 4-31
Add button 4-5, 4-8, 4-10, 4-14, 4-28 Automatic safety functions 5-11
Add Channel button 4-29 B
Administrator 1-36, 2-5, 2-7 Backup & Restore tab 4-16, 4-30
Administrator user 4-6 Backup button 4-32
Afterloader description 1-12 Backup File button 4-32
Afterloader Errors and Messages A-2 Backup file field 4-32
Afterloader keypad 1-15 Backup frequency (days) text field 4-31
Afterloader specifications C-2 Battery key switch 1-5, E-2
Agreement State 1-2, 1-3, 1-7, 6-2 BATTERY light 1-20
Air kerma B-8, D-2 Battery supply 1-5, 1-12, 1-20
Air quality 1-10 Battery-backed SRAM storage 3-36, 4-48
ALARM indicator 5-6 Birth date field 2-27
ALARM RESET button 1-22, 5-9 Boundary Lock button 2-35, 2-39
ALARM section 1-22 BrachyVision™ 2-2, 2-6, 2-31, 3-5
ALARM signal 5-7 Bronchial catheter 3-5, 7-4, F-3
Alarm symbol 1-22 BUZZER OFF button 1-22, 1-23, 5-7
Alias field 4-12, 4-14 BUZZER OFF indicator 1-22, 5-7
All logs option 4-19 C
Allowed field 4-8 Calculations B-1
Annotate Messages tab 4-16, 4-22 Cancel button 1-36
Annual maintenance 6-2 Catheter length field 3-26
Applicator 1-12, 3-4, 3-10, 3-12, 3-31, 5-21, Change Filter button 2-8
7-2, 7-4, D-15, F-2, F-3 Channel Edit Strip 2-33
Applicator Definitions tab 4-16, 4-27 Channel end test 3-5, 3-23, 7-4, F-3
Applicator field 2-20 Channel length field 4-28, 4-40
Applicator list 2-29, 4-24, 4-25 Channel name field 3-26, 4-28, 4-29
Applicator manufacturer field 4-29 Channel number 2-35, 3-10
Applicator name field 4-28, 4-29 Channel number field 3-26, 4-28, 4-29
Applicator table 4-28

Index-1
GM10 UG Book.book Page 2 Tuesday, March 24, 2009 11:22 AM

Channel View Strip 2-31, 3-26, 7-3, F-2 Database port 4-37
Channel View table 3-26 Database service IP address 4-37
CHARGE light 1-16 Date and time setting 4-34
Chassis 1-12 Date cleared field 4-19
Class field 4-19 Date delivered field 2-20
Clean the GammaMedplus D-11 Date occurred field 4-19
Clear Error button 3-28, 3-36 Dates and times 1-33
Code field 4-19 Daylight Savings Time 4-34
Comma separated value (.CSV) file 4-21 Days since last source exchange icon 1-38
Competent Authority 1-2, 1-3, 1-7, 6-2 Decay Frequency button 4-46
COMPLETED indicator 1-22, 3-29 Default button 4-9
Connecting cables 3-7 Delete Channel button 4-29
Console & Afterloader Strip 4-1, 4-16 Delete File button 2-10
Console entry date field 2-20, 4-40 Delete Fraction button 2-21
Contact name field 4-11 Delete Record button 2-15
Contact phone field 4-11 Deliver Treatment button 3-19
Contamination checks 1-9 Delivery status field 2-12, 2-20, 4-25, 4-41
Continue button 2-10, 2-11 Description field 4-19, 4-20
Control Console 1-18, 2-40, 3-19, 3-24, Device housing 1-4, 1-12, 1-13
3-29, 3-32, 3-33, 4-46, 5-8, 5-11, 5-14, 5-17, Diagnostic file export 4-13
D-12, D-13, E-2 Directional scroll buttons 2-35
Control PC description 1-25 Directives 3-27
Control software description 1-31 Distal offset field 4-41
Control Software Errors and Messages A-6 Distal offset of the source 1-20
Conversion factor option buttons 4-34 Distal position of the source 1-16, 2-34,
Copy and Add Fraction button 2-21 2-39, 4-41
Copy button 2-39, 4-9 DOOR indicator 1-24
Copy Patient Plan button 4-25, 4-41 Door interlock 1-26
Create New Patient File button 1-32, 2-26 Door interlock test D-7
Create New Patient File workflow 1-34, 2-1, DOOR light 1-22, 1-23
2-24, 2-25, 2-30, 2-33, 4-23 DUMMY section 1-16, 2-40
Current dwell time field 3-26 Dummy sequence 4-36
Current source strength 1-38 Dummy wire 1-12, 1-17, 2-40, 3-20, 3-22,
Current source strength icon 1-38 3-23, 6-4, 7-4, F-3, F-1
Current value field 4-17, 4-33 Dummy wire sequence 3-22
Cycles icon 1-37 Dummy wires table 4-50
D Dwell points 2-32, 2-37, 3-27
Data Disclosure button 2-16 Dwell position 1-1, 1-12, 2-37, 3-5
Data Disclosure Report 2-16 Dwell positions field 3-26
Data Reconciliation Page 2-12 Dwell Selector 2-36
Data Verification Page 2-11 Dwell Selector Range 2-35, 2-39
Database Service Settings Dwell time 1-1, 2-33, 2-38, 3-5
Database AE Title 4-37 Dwell Time Lock 2-38

Index-2 GammaMedplus iX User Guide


GM10 UG Book.book Page 3 Tuesday, March 24, 2009 11:22 AM

Dwell time resolution B-6 F


Dwell Time Scale 2-38 File Location button 2-7, 4-13, 4-31, 4-32,
Dwell time scale field 2-35 4-33
E File Location list 4-31
Edit an active treatment record 2-5 File type list 4-12, 4-14
Edit Channel button 2-33 Filter on check box 4-21
Edit Password button 1-36 Filter records 4-20
Edit Password Strip 1-36 First name field 2-11, 2-27
EMERGENCY button 1-17, 1-22, 3-25, Folder field 4-12, 4-14
5-12, 5-16, 5-23, D-12 Folder Setup tab 4-4, 4-12, 4-31, 4-33
Emergency Contact Information 5-2 Foot brake 1-6, 1-7, 1-13, 3-7, 3-10
Emergency container 1-5, 1-29 Forceps 1-29
Emergency equipment 5-5 Fraction Creation Page 2-24, 2-28
Emergency Response Procedures 5-13, Fraction field 2-20
D-16 Fraction View Page 2-2, 2-19
Emergency retract system 1-12 Fraction View Table 2-20
Emergency retraction 5-12 G
EMERGENCY RETURN switch 3-24, GammaMedplus 3/24 iX system 7-1
3-25, 5-12, 5-14, 5-23, D-6, D-12 GammaMedplus afterloader 3-5, 3-36, 7-2,
Emergency return switch interlock 1-26 F-2
Enable appointment integration 2-7 GammaMedplus calculations B-1
Enable ARIA integration 2-7 GammaWin™ 2-6
End time field 2-20 Geiger-Müller detector 5-10, 5-16
Enter value field 4-20 General ARIA Settings 4-36
Environmental control 1-5, 1-10 AE Title 4-36
Error and emergency messages 3-27 Enable appointment integration 4-36
Error code & class icon 1-37 Enable ARIA integration 4-36
Error code field 4-22 IP address 4-37
Error conditions 6-4 Listen port 4-37
Error log 4-19 Machine name 4-37
Error log export location 4-13 Graphical representation of channels 3-26
Error Log tab 3-28, 4-16, 4-18 Group button 4-8
Error message field 4-22 Group field 4-5
Event log 4-19 Group name field 4-8
Exchange date field 4-49, 4-50 Groups tab 4-4, 4-7
Export a Treatment File 2-14 Guide for source exchange E-3
Export button 2-15 H
Export diagnostic files 4-33 Handcrank 1-13, 1-14, 5-12, 5-18, 5-19,
Export Location 2-14 D-13, D-14
Export Location button 2-15, 4-13, 4-21 Hazards
Export Location list 4-21 Electrical shock 1-6
Extended Sound Functionality 1-23 Explosion 1-9
Fire 1-9

Index-3
GM10 UG Book.book Page 4 Tuesday, March 24, 2009 11:22 AM

Personal injury 1-7 Last name field 2-11, 2-27


Radiation concerns 1-7 Length field 2-34
Radioactive contamination 1-9 Length gauge 3-5, 3-8, 3-23, 7-4, F-3
HDR Treatment Sequence 3-2 Licensing requirements 6-2
HEAD section 1-16, 3-8 Location address field 4-10
Height adjustment 3-8 Location drop-down list 1-36
Humidity 1-10 Location field 4-5, 4-6, 4-11
I Location notes field 4-10
Idle time-out 4-35 Locations tab 4-4, 4-10
IEC 60601-2-17 requirements D-2 LOCKED (vertical) position 3-32
Import a treatment file 2-3, 2-6 LOCKED indicator 1-15, 1-20
Import Plan button 2-7 Log On button 1-36
IN and OUT buttons 2-40 Log Out button 1-36, 3-32
Inactive record 2-13 Login account 1-31
Inactive treatment records table 2-13 M
Inactive user 4-6 Machine field 4-19, 4-50
Independent radiation monitoring system Machine serial number 4-15
1-6, 1-17, 5-17, D-13, E-2 MAINS light 1-20, 3-19
Indexer head 1-12, 3-8, 3-10, 5-21, 7-4, Make Active button 2-14
D-10, D-15 Make Inactive button 2-14
Indicator test 1-30 Manual backup console system files group
Initial dummy wire test 3-22 box 4-31
Initiate a treatment 3-14 Manual recovery of the source 5-18, 5-20,
Initiate Treatment button 2-33, 3-13, 3-14 D-14
Installation and initiation of operation 6-2 Manually retract the source 5-19, D-14
International Electrotechnical Commission Manufacturer measured source strength
(IEC) 1-6 4-47, B-3
Interrupt (or warning) messages 3-27 Manufacturer source strength 4-45
INTERRUPT button 1-22, 3-24, 3-25, 3-33, Matches field 2-20, 2-21
5-12, 5-14, D-5, D-12 Maximum source strength values group box
INTERRUPTED indicator 1-22 4-50
Interruption Data section 2-18, 2-22 Maximum usable dwell times 3-15
Interruption of treatment D-5 Minimum usable dwell times 3-15
Ir-192 source decay table B-4 MODE key interlock 1-26
Iridium-192 source 1-1, 1-7, 1-12, 1-15, 6-3, MODE key switch 1-20, 1-30, 2-40, 3-19,
7-2, F-1 4-46, 4-47
K MODE section 1-20
Key field 1-35 Modified date 2-15
Key switch for battery supply 1-13 Moving the GammaMedplus E-5
Key tests D-9 N
L Name field 2-34
Last Man Out button 3-18 Network connectivity 1-38
Last Man Out Functionality 1-24 New button 4-24, 4-40

Index-4 GammaMedplus iX User Guide


GM10 UG Book.book Page 5 Tuesday, March 24, 2009 11:22 AM

No Appointment button 2-8 Plan name field 4-23, 4-39, 4-40


Normal form radioactive material 1-2 Planned by field 2-20
NORMAL indicator light 3-19 Planned dwell time column 3-14
Notes field 4-22, 4-50 Planned source strength field 2-20, 2-29,
Number of channels field 4-40 4-40
Number of dwells field 4-40 Planned Treatment Report 3-15
Number of fractions field 2-29 Planned/ Actual Comparison report section
O 2-17
Observation equipment D-10 Portable radiation meter 1-17
Oncologist user 4-6 Portable survey meter 5-16, 5-19, D-12,
Open Patient File button 1-32, 2-3 D-14
Open Patient File workflow 1-34, 2-1, 2-2, Power and power failure test D-8
2-24, 2-30, 3-12, 3-37 POWER key 1-20, 3-19, 3-32, 5-23, E-2
Operating environment 1-10 POWER key switch 1-30
Operator field 1-36, 2-20 POWER key switch test D-9
Origin button 2-34, 2-39 POWER light 1-16
Origin field 2-34 POWER section 1-20
Origin offset 2-40 Power supply 5-17, D-13
OUT indicator 3-23 Preventive Maintenance (PM) 6-2
Owner Information tab 4-4, 4-15 Previous button 2-11, 2-23, 4-26
P Print button 2-16
Page Up and Page Down keys 2-32 Print Fraction Report button 2-21
Partial Treatment Options 3-25, 5-23 Printer 1-25
Partial Treatment Strip 2-30, 3-34, 3-36, Privilege field 4-8
3-37, 5-23 Proceed button 2-23, 2-27
Password 4-43 Q
Password expires field 4-5 Qualified user 1-2, 1-4
Password field 1-36, 4-5, 4-6, 4-44 R
Passwords 4-6 Radiation hazard 5-4
Paste button 2-39 RADIATION indicator 1-17, 1-20, 1-30,
Patient Creation Page 2-24, 2-26 3-29, 5-8, 5-10
Patient data verification 2-11 Radiation level 5-21, A-1, D-15
Patient demographic data 2-26 Radiation monitor 3-23
Patient ID1and ID2 fields 2-27 Radiation Safety Officer 1-5, 1-9, 3-13, 5-12
Patient identification field 4-25, 4-41 RADIATION section 1-17
Patient Selection Page 2-2, 2-12 RADIATION symbol 3-24, 3-34, 5-11, 5-15
Patient Selection Strip 2-5 Radiation therapist user 4-6
Patient treatment plan location 4-13 Radioactive materials license 1-4
Physical field 4-50 Recalibration 1-35, 4-44, E-1
Physician field 2-27 Record Maintenance button 2-12
Physicist user 4-6 Record Type button 2-13
Physics Test Report 4-42 Registry of Radioactive Sealed Sources and
Plan Import Wizard 2-7, 2-9, 2-15 Devices 1-7

Index-5
GM10 UG Book.book Page 6 Tuesday, March 24, 2009 11:22 AM

Regulatory terms 1-2 Shock and vibration 1-10


RELEASED indicator 1-15, 3-18 Shut Down button 3-32
Remaining treatment time field 3-26 Shutdown button 1-32
Remove the applicator from the patient Site calibrated source strength 4-44, 4-45,
5-20, D-14 4-47
Repeated Tone Functionality 1-23 Source & Wire button 4-38
Report file export 4-13 Source & Wire Strip 4-1, 4-38
Reports box 2-16 Source decay calculation B-3
Restart the system 5-22, 5-23 Source decay table B-4
Restore button 4-32 Source exchange 1-4, 6-3
Restore system files group box 4-32 Source Exchange tab 4-38, 4-48
Retract the source 5-14, D-12 Source guide tube support 3-11, 7-5
Room radiation monitor D-10 Source guide tubes 3-8, 3-10, 3-32, 7-4
Run Plan button 4-42 SOURCE key 3-18, 3-32
S SOURCE key interlock 1-26
SAFE indicator 3-23, 3-29, 3-34, 5-8, 5-15 SOURCE key switch 1-15, 1-30
Safety and alarm functions 5-1, D-1 SOURCE key switch test D-9
Safety check 1-5 Source locking wire 1-5, E-3
Safety information D-2 Source motor drive 1-17
Operation 1-3 SOURCE OUT indicator 5-11
Safety notices 1-4 SOURCE section 1-15, 1-20, 3-6, 3-23,
Safety interlocks 1-25 3-24, 3-29, 5-8, 5-15
Save button 1-36 Source strength field 4-24, 4-25, 4-39
Scaled dwell time column 3-14 Source strength option buttons 4-34
Scaled dwell time field 3-26 Source Strength tab 1-31, 4-38, 4-44
Scroll Handle 2-37 Source wire 3-23, 6-3
Second name field 2-27 Special form radioactive material 1-2, 1-7,
Secure System button 2-4, 4-35 1-9
Secure system mode 1-37, 2-4 SPECIAL indicator 4-46
Secure time-out 4-35 SPECIAL mode 1-20, 2-40
Select a patient treatment file 2-5 Standard plan list 2-29
Select Field button 4-20 Standard Plans tab 4-16, 4-23
Select Function button 4-20 Standard plans table 4-26
Select Log button 4-13, 4-19 START button 1-22, 1-26, 2-40, 3-19, 5-9,
Selected patient data 2-5 5-22
Service engineer account 4-6 Start Page 1-32, 4-31
Service engineers 6-1 Start Test button 4-43
Service Parameters tab 4-38, 4-51 Start time field 2-20
Service visits 6-2 STARTED indicator 1-21, 3-19
Set Up button 4-26 Starting dwell position field 4-40
Setting field 4-33 Starting the GammaMedplus system 1-30
Sex field 2-27 Status (or information) messages 3-27
Shielded facility 1-4 Status field 3-23, 3-27

Index-6 GammaMedplus iX User Guide


GM10 UG Book.book Page 7 Tuesday, March 24, 2009 11:22 AM

Status item field 4-17 Treatment plan 3-5


Steam sterilization 1-5 Treatment plan export location 4-13
Step size field 2-34, 4-41 Treatment position 3-7
Strips (description of) 1-33 Treatment Record Maintenance Strip 2-12
System backup location 4-13 Treatment Recovery Report 3-37
System Commands tab 4-38, 4-52 TREATMENT section 1-21, 3-19, 3-29
System component connections C-4 Treatment site field 4-25, 4-41
System Configuration button 1-32, 4-2 Treatment site list 2-27, 4-23, 4-24
System Configuration Page 4-2, 4-16, 4-38 Type A container 1-5
System Configuration workflow 1-34 U
System Installation 6-2 United States Nuclear Regulatory Commis-
System Settings tab 4-17, 4-33 sion (USNRC) 1-2, 1-3, 1-7, 6-2
System Status Strip 1-37, A-1 Up and Down arrow keys 2-32
System Status tab 4-16, 4-17 UP and DOWN buttons 1-16, 3-8
T User & Location button 4-4
Technical description C-1 User & Location Strip 4-1, 4-3
Temperature 1-10 User field 4-5, 4-19
Test ARIA Settings User Info Strip 2-3
Database button 4-37 User Login Page 1-35, 2-2, 2-5, 2-24
Worklist button 4-37 User table 4-5
Test Mode indicator 1-32 Users tab 4-4
Test Plans tab 4-38, 4-39 V
Test plans table 4-39, 4-43 Varian authorized service personnel 1-7,
Tests and checks D-4 1-20, 1-31
Time per dwell field 4-41 Varian Medical Systems service engineers
Time values 4-34 1-4, 1-8, 1-13, 6-2, 6-3
Total dwell positions field 2-35 Verification requirements 2-10
Total dwell time field 2-35 View and Edit Channel Data 2-1
Total/ used cycles 4-50 View Detail button 3-28, 4-22, 5-8
Transit absorbed dose B-8 Viewing and intercom systems 1-28
Transit dose B-5 W
Transit dose algorithm B-5 Wheels 1-12
Transport 1-7, 1-8, 1-11, 1-16, 7-6, E-1 Windows Regional Settings 1-33
Treatment Code 3-16, 3-17, 3-19, 4-43 Wire field 3-23, 3-27
Treatment Day Tests and Checks 3-3 Wire path constraint 1-iv
Treatment Delivery Page 2-2, 2-24, 2-30, Wire position 3-21
3-13, 3-20, 3-25, 4-26 Wire serial field 4-49, 4-50
Treatment Delivery Report 3-30 Wire Type button 4-49
Treatment Delivery Strip 3-27 Worklist Service Settings
Treatment file selection 2-7 Worklist AE Title 4-37
Treatment History Report 2-17 Worklist port 4-37
Treatment Initiation Strip 3-14 Worklist service IP address 4-37
Treatment interruption 3-36

Index-7
GM10 UG Book.book Page 8 Tuesday, March 24, 2009 11:22 AM

X
XML file 2-6, 2-15

Index-8 GammaMedplus iX User Guide

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