HARDWARE STEREOTACTIC RT / RS · Radionics (Integra Radionics, Inc.) Burlington, MA, USA...

RT / RSSTEREOTACTICHARDWARE

Hardware User GuideRevision 4.9Copyright 2016, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTSGENERAL INFORMATION ...................................................................................................7

Contact Data and Legal Information ......................................................................................................7Contact Data ................................................................................................................................................7Legal Information .........................................................................................................................................8

Symbols .....................................................................................................................................................10Symbols Used in This Guide ......................................................................................................................10Hardware Symbols.....................................................................................................................................11

Intended Use .............................................................................................................................................12

Compatibility with Medical Devices .....................................................................................................13Brainlab Medical Devices...........................................................................................................................13Non-Brainlab Medical Devices ...................................................................................................................16

Training & Documentation .....................................................................................................................20Training......................................................................................................................................................20Documentation...........................................................................................................................................21

HARDWARE OVERVIEW ....................................................................................................23

Brainlab Couchmount .............................................................................................................................23Preparing and Handling Couchmounts.......................................................................................................23Siemens ZXT, Elekta/Philips RAM, and Varian ETR Couch Tops ...............................................................26Siemens ZXT Carbon Fiber Couch Top......................................................................................................27Varian Exact and Siemens TT-S Couch Tops .............................................................................................28Couchmount Lite........................................................................................................................................30

Couchmount Adapters............................................................................................................................31Couchmount Adapter Types.......................................................................................................................31Couchmount Adapters: Brainlab Headring Models.....................................................................................32

Collimator Mount......................................................................................................................................33Overview....................................................................................................................................................33Attaching the Collimator Mount ..................................................................................................................34Detaching the Collimator Mount .................................................................................................................35Collimator Mount Siemens with Coded Plug ..............................................................................................36Third-Party Labels on the Brainlab Collimator Mount .................................................................................40Using Conical Collimators ..........................................................................................................................41Third-Party Labels on Brainlab Collimators ................................................................................................46

IMMOBILIZATION HARDWARE ....................................................................................47

Stereotactic Headring .............................................................................................................................47Overview....................................................................................................................................................47

TABLE OF CONTENTS

Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware 3

Stereotactic Headring Components............................................................................................................48Attaching the Fixation Posts.......................................................................................................................51Adjusting the Torque Wrench .....................................................................................................................52Affixing the Stereotactic Headring to the Patient ........................................................................................54

Stereotactic Mask System......................................................................................................................57Mask System Components ........................................................................................................................57Molding the Mask.......................................................................................................................................60Removing and Reattaching the Mask.........................................................................................................65

Upper Jaw Support ..................................................................................................................................67Components ..............................................................................................................................................67Attaching the Upper Jaw Support...............................................................................................................69

IMAGING.............................................................................................................................................71

Imaging with the Headring and Mask System ...................................................................................71Localizer Design ........................................................................................................................................71Attaching the Localizer...............................................................................................................................73Angio Distortion Correction Module............................................................................................................75

POSITIONING FOR TREATMENT ...............................................................................77

Stereotactic Target Positioner...............................................................................................................77Overview....................................................................................................................................................77Attaching the Overlays and Carrier Plates..................................................................................................79Mounting the Stereotactic Target Positioner ...............................................................................................80Positioning the System for Treatment.........................................................................................................81Using the Stereotactic Counterweight ........................................................................................................82

Target Positioner for Leksell Headring ...............................................................................................84Overview....................................................................................................................................................84Attaching the Overlays and Carrier Plates..................................................................................................85Mounting the Target Positioner for Leksell Headring ..................................................................................86Positioning the System for Treatment.........................................................................................................87

QUALITY ASSURANCE .......................................................................................................89

Winston-Lutz Test ....................................................................................................................................89Testing with the Phantom Pointer for Brainlab Headring.............................................................................90Testing with the Phantom Pointer for a non-Brainlab Headring...................................................................92Film Exposure ............................................................................................................................................94

CLEANING, DISINFECTION, AND STERILIZATION ..................................95

Reprocessing ............................................................................................................................................95Automatic Cleaning and Disinfection..........................................................................................................95Neutral Steam Sterilization.........................................................................................................................97Low Temperature Plasma Sterilization (LTP)..............................................................................................98

Stereotactic Hardware.............................................................................................................................99Overview....................................................................................................................................................99

TABLE OF CONTENTS

4 Hardware User Guide Rev. 4.9 RT / RS Stereotactic Hardware

Stereotactic Headring...............................................................................................................................100Stereotactic Mask System........................................................................................................................102Upper Jaw Support and Reference Plates ...............................................................................................103CT/X-Ray Localizer, CT/X-Ray Localizer for Leksell Headring .................................................................104Stereotactic Target Positioner, Target Positioner for Leksell Headring......................................................105

INDEX ..................................................................................................................................................107

TABLE OF CONTENTS


TABLE OF CONTENTS


1 GENERAL INFORMATION1.1 Contact Data and Legal Information1.1.1 Contact Data

Support

If you cannot find information you need in this guide, or if you have questions or problems, contactBrainlab support:

Region Telephone and Fax Email

United States, Canada, Central andSouth America

Tel: +1 800 597 5911Fax: +1 708 409 1619 [email protected]

Brazil Tel: (0800) 892 1217

UK Tel: +44 1223 755 333

[email protected]

Spain Tel: +34 900 649 115

France and French-speaking regions Tel: +33 800 676 030

Africa, Asia, Australia, EuropeTel: +49 89 991568 44Fax: +49 89 991568 5811

JapanTel: +81 3 3769 6900Fax: +81 3 3769 6901

Expected Service Life

Brainlab provides a minimum of five years of service for system components. During this timeperiod, spare parts as well as field service are offered.

Feedback

Despite careful review, this manual may contain errors.Please contact us at [email protected] if you have suggestions as to how we canimprove this manual.

Manufacturer

Brainlab AGOlof-Palme-Str. 981829 MunichGermany

GENERAL INFORMATION


mailto://[email protected]



1.1.2 Legal Information

Copyright

This user guide contains proprietary information protected by copyright. No part of this guide maybe reproduced or translated without the express written permission of Brainlab.

Brainlab Trademarks

• BrainSCAN™ is a trademark of Brainlab AG.• iPlan® is a registered trademark of Brainlab AG in Germany and/or the US.

Non-Brainlab Trademarks

• Exact™ is a trademark of Varian Medical Systems, Inc.• Microsoft® and Windows® are registered trademarks of Microsoft Corporation.• Leksell® Coordinate Frame G is a registered trademark of Elekta AB.• STERRAD® 100S is a registered trademark of Advanced Sterilization Products.• iBEAM® is a registered trademark of Medical Intelligence Medizintechnik GmbH.• kVue™ and Quantum™ are trademarks of WFR-Aquaplast/Q-Fix Systems.

CE Label

• The CE label indicates that the Brainlab product complies with the essential re-quirements of European Council Directive 93/42/EEC, the Medical Device Di-rective (MDD).

• According to the rules established by the MDD, the Linac Hardware, Stereo-tactic Headring and Stereotactic Mask System are Class I products.

Warranty

Warranties do not apply to products that have been damaged due to accidents, misuse,improper re-installation, or inadequate packaging in the case of return shipments.Warranties do not apply to product components that have been modified or replacedwithout the written authorization of Brainlab.

Disposal Instructions

Only dispose of electrical and electronic equipment in accordance with statutory regu-lations. For information regarding the WEEE (Waste Electrical and Electronic Equip-ment) directive, visit:www.brainlab.com/en/sustainability

The collimators contain lead and should only be disposed of in accordance with statutoryregulations.

Sales in the US

U.S. federal law restricts this device to sale by or on the order of a physician.

Contact Data and Legal Information


http://www.brainlab.com/en/sustainability/

Language Information

All Brainlab user guides are originally drafted in English.

GENERAL INFORMATION


1.2 Symbols1.2.1 Symbols Used in This Guide

Warnings

Warnings are indicated by triangular warning symbols. They contain safety-criticalinformation regarding possible injury, death or other serious consequences associatedwith equipment misuse.

Cautions

Cautions are indicated by circular caution symbols. They contain safety-critical informationregarding possible problems with the device. Such problems include device malfunctions,device failure, damage to device or damage to property.

Notes

NOTE: Notes are formatted in italic type and indicate additional useful hints.

Symbols


1.2.2 Hardware Symbols

Symbols on Hardware Components

Symbol Explanation

Class I Type B equipment according to IEC 60601-1

Attention: Consult accompanying documents.

MR Unsafe

GENERAL INFORMATION


1.3 Intended Use

Indications for Use

The stereotactic hardware supplements the Linac in applying stereotactic radiosurgery andradiotherapy. The hardware includes a collimator system, components to fixate and position apatient for radiotherapy or radiosurgery treatments, and means of quality assurance forradiotherapy or radiosurgery treatments.

Careful Handling of Hardware

RT/RS Stereotactic Hardware components and accessory devices comprise precisemechanical parts that must be handled with care. Even minor damage to any of these partsmay render the entire apparatus inoperable. Do not use RT/RS Stereotactic Hardwarecomponents if they are in any way warped, scratched, damaged, or any of the parts areloose. The equipment must be checked and tested for proper functionality prior to eachtreatment.

RT/RS Stereotactic Hardwarecomponents and accessory devices may only be operated bytrained medical personnel.

Hardware Modification

No modification of the RT/RS Stereotactic Hardware is allowed.

Compatibility with Non-Brainlab Software

RT/RS Stereotactic Hardware components may only be used with a Brainlab treatmentplanning system.

MR Compatibility

All Brainlab devices and parts mentioned in this user guide are explicitly indicated as MRunsafe (according to ASTM F2503-05) and must not be used in any other imaging devices,except where specifically noted. This also applies to all non-metal devices and parts.

Intended Use


1.4 Compatibility with Medical Devices1.4.1 Brainlab Medical Devices

Background

RT/RS Stereotactic Hardware is compatible with the following Brainlab medical devices:

CT/X-Ray Localizer

Localizer Types Compatible Devices

CT/X-Ray LocalizerHeadring

Stereotactic Mask System

CT/X-Ray Localizer and CT/X-Ray Local-izer for Leksell BrainSCAN, iPlan RT Dose, iPlan RT Image

Target Positioner

Target Positioner Types Compatible Devices

Stereotactic Target PositionerHeadring


Stereotactic Target Positioner and TargetPositioner for Leksell Headring BrainSCAN, iPlan RT Dose, iPlan RT Image

Headring

Compatible Devices

Stereotactic Target Positioner

CT/X-Ray Localizer

Couchmount Adapter Brainlab Headring

Fixation Pins Brainlab Multiuse

Couchmount Adapter Brainlab Headring (for Elekta Couch)

Fixation Pins Brainlab Multiuse

Compatible Devices

Headring


Compatible Devices


CT/X-Ray Localizer


Mask Set for one patient

GENERAL INFORMATION


Compatible Devices

Upper Jaw Support for Mask System


Couchmount

Compatible Devices



Couchmount Adapter Radionics Headring

Couchmount Adapter Leksell Headring

Couch Adapter for Imaging Couch Top

Phantom Pointer for non-Brainlab Headring

Couchmount Lite

Compatible Devices



Couchmount Adapter Radionics Headring

Couchmount Adapter Leksell Headring

Couch Adapter for Imaging Couch Top

Phantom Pointer for non-Brainlab Headring

Couchmount Adapter

Couchmount Adapter Types Compatible Devices

All types Couchmount

All types Couchmount Lite

Brainlab Headring, Brainlab Headring (forElekta Couch)*

Headring


Phantom Pointer for Brainlab Headring

*For Elekta Couch with restricted isocenter clearance.

Collimator Mount

Collimator Mount Types Compatible Devices

Varian without MLCVarian with MLCSiemens with Coded Plug

Conical Collimator

Varian without MLC Film Holder Varian without MLC

Varian with MLC Film Holder Varian with MLC

Siemens with Coded Plug Film Holder Siemens

Compatibility with Medical Devices


Conical Collimator Set

Compatible Devices

Collimator Mount (all)

Phantom Pointer

Phantom Pointer Types Compatible Devices

Brainlab HeadringCouchmount Adapter Brainlab Headring

Couchmount Adapter Brainlab Headring (for ElektaCouch)

Non-Brainlab Headring Couchmount (all types)

Film Holder

Film Holder Types Compatible Devices

Varian without MLC Collimator Mount Varian without MLC

Varian with MLC Collimator Mount Varian with MLC

Siemens Collimator Mount Siemens with Coded Plug

Other Brainlab Devices

Only devices and spare parts specified by Brainlab may be used with these medicaldevices. Using unauthorized devices/spare parts may adversely affect the safety and/or theeffectiveness of the medical devices and endanger the safety of the patient, user and/orenvironment.

RT/RS Stereotactic Hardware system components may only be used with a Brainlabtreatment planning system.

GENERAL INFORMATION


1.4.2 Non-Brainlab Medical Devices

CT/X-Ray Localizer

Localizer Types Model Manufacturer

CT/X-Ray Localizer BRW-HR and UCHR-APAdapter for UCHR Headring

Radionics (Integra Radionics, Inc.)Burlington, MA, USA

CT/X-Ray Localizer for Lek-sell G-Frame Headring Elekta AB, Stockholm, Sweden

Target Positioner

Target Positioner Types Model Manufacturer

Stereotactic Target Position-er

BRW-HR and UCHR-APAdapter for UCHR Headring

Radionics (Integra Radionics, Inc.)Burlington, MA, USA

Target Positioner for LeksellHeadring G-Frame Headring Elekta AB, Stockholm, Sweden

Fixation Pins Radionics Multiuse

Compatible Devices Manufacturer

BRW-HR Radionics (Integra Radionics, Inc.) Burlington, MA,USA



Radionics Localizer BRW- LF Radionics (Integra Radionics, Inc.) Burlington, MA,USA

Headring


Radionics Localizer BRW- LF Radionics (Integra Radionics, Inc.) Burlington, MA,USA

Couchmount

Brainlab CouchmountTypes

Compatible Couch Tops Manufacturer

Brainlab Imaging CouchTop / Varian Exact

Couch Top Varian ExactVarian, Oncology Systems,Palo Alto, USA

Varian IGRT Couch Top with VarianIGRT Head End Interface, Revision 2008or later

iBEAM Couch Top with iBEAM CouchAdapter Medical Intelligence, Ger-

manyiBEAM evo Couch Top with iBEAM evoCouch Adapter



Brainlab CouchmountTypes


Connexion Couch Top with ConnexionHead & Neck Module (P10105-213)

kVue IGRT Couch Top with kVue Univer-sal Tip Extension WFR-Aquaplast/Q-Fix Sys-

tems, New Jersey, USAQuantum Couch Top with Quantum Uni-versal Tip Extension

CIVCO Mastercouch Stereotactic Treat-ment Module (MC STERM), RevisionFeb. 2009 or later

CIVCO Medical Systems,Kalona, USA

CIVCO MTIL3015 Siemens TT-M Tab-letop Revision Nov. 2010 or later

CIVCO medical solutions,Kalona, USA

CIVCO MTIL3010 and MTIL3005 (usedfor Siemens ZXT Pedestal) RevisionNov. 2010 or later


CIVCO MTIL6610 and MTIL6667 (Uni-versal Couch Top Varian Interface) Revi-sion Nov. 2010 or later


CIVCO MTIL6612 (Universal Couch TopOne Piece Varian Interface) RevisionNov. 2010 or later


Varian ETR Couch Top Varian ETR Varian, Oncology Systems,Palo Alto, USA

Siemens ZXTCouch Top Siemens ZXT

Siemens Medical Systems,Inc, Oncology Care Sys-tems, Concord, USA

AK550 IGRT Carbon Fiber Couch Top Aktina Medical, New York,USA

Siemens ZXT CarbonFiber Couch Top Siemens ZXT Carbon Fiber Siemens Medical Systems,

Inc, Oncology Care Sys-tems, Concord, USASiemens TT-S Couch Top Siemens TT-S

Elekta/Philips RAM Couch Top Elekta/Philips RAM Elekta AB, Stockholm,Sweden

Couchmount Lite

Brainlab CouchmountLite Types


Brainlab ImagingCouch Top / Varian Ex-act

Couch Top Varian ExactVarian, Oncology Systems,Palo Alto, USA

Varian IGRT Couch Top with Varian IGRTHead End Interface, Revision 2008 or lat-er

iBEAM Couch Top with iBEAM CouchAdapter

Medical Intelligence, Ger-many

iBEAM evo Couch Top with iBEAM evoCouch Adapter

Connexion Couch Top with ConnexionHead & Neck Module (P10105-213)

kVue IGRT Couch Top with kVue Univer-sal Tip Extension

WFR-Aquaplast/Q-Fix Sys-tems, New Jersey, USA

GENERAL INFORMATION


Brainlab CouchmountLite Types


Quantum Couch Top with Quantum Uni-versal Tip Extension

CIVCO Mastercouch Stereotactic Treat-ment Module (MC STERM), RevisionFeb. 2009 or later


CIVCO MTIL3015 Siemens TT-M Tab-letop Revision Nov. 2010 or later

CIVCO medical solutions,Kalona, USA

CIVCO MTIL3010 and MTIL3005 (usedfor Siemens ZXT Pedestal) Revision Nov.2010 or later


CIVCO MTIL6610 and MTIL6667 (Uni-versal Couch Top Varian Interface) Revi-sion Nov. 2010 or later


CIVCO MTIL6612 (Universal Couch TopOne Piece Varian Interface) RevisionNov. 2010 or later


Varian ETR Couch Top Varian ETR Varian, Oncology Systems,Palo Alto, USA

Siemens ZXTCouch Top Siemens ZXT


AK550 IGRT Carbon Fiber Couch Top Aktina Medical, New York,USA

Elekta/Philips RAM Couch Top Elekta/Philips RAM Elekta AB, Stockholm,Sweden

Couchmount Adapter

Brainlab Couch-mount AdapterTypes

Compatible Devi-ces

Model Manufacturer

Radionics HeadringHeadring

BRW-HR (and com-patible headrings)

Radionics (Integra Radion-ics, Inc.) Burlington, MA,USA

Leksell Headring G-Frame Elekta AB, Stockholm, Swe-den

Collimator Mount

Collimator MountTypes

Compatible Linac Types Manufacturer

Varian without MLC Varian without MLC (Varian Clinacs withType III Tray Slot)

Varian, Oncology Systems,Palo Alto, USA

Varian with MLC

Varian with MLC (Varian Clinacs withType III Tray Slot)

Novalis TxTrueBeam



Collimator MountTypes

Compatible Linac Types Manufacturer

Siemens with CodedPlug

• Siemens PRIMUS with 3D-MLC(58MLC)

• Siemens PRIMUS with OPTIFOCUSMLC (82MLC)

• Siemens ONCOR with 3D-MLC(58MLC)

• Siemens ONCOR with OPTIFOCUSMLC (82MLC)

• Siemens ONCOR with 160 MLC• Siemens Artiste

NOTE: Requires LINAC Console Soft-ware Version 12.0 or higher and R&VSystem Syngo RT Therapist 4.2 or high-er.


Other Non-Brainlab Devices

Non-Brainlab medical devices may only be used with these medical devices if specified byBrainlab. Using unauthorized medical devices may adversely affect the safety and/oreffectiveness of these medical devices and endanger the safety of the patient, user and/orenvironment.

GENERAL INFORMATION


1.5 Training & Documentation1.5.1 Training

Brainlab Training

In order to ensure safe and appropriate use of the system, Brainlab recommends that beforeusing the system for the first time, all users should participate in an extensive training programheld by a Brainlab representative.

Supervised Support

• After a sufficient number of complete procedures has been successfully simulated, andfollowing a rigorous quality assurance review, the system can be used in selected treatments.

• A Brainlab representative must be present at such treatments to provide medical staff withsupervision and guidance where necessary.

Training & Documentation


1.5.2 Documentation

Reading the User Guides

Successful and safe treatment using stereotactic hardware requires careful procedural planning.It is therefore important that:• The relevant user guides are read carefully before using the system• Access is provided to these user guides at all times

Available User Guides

User Guide Description

iPlan Dose Clinical UserGuide Detailed instructions on using the relevant Brainlab treatment

planning systemBrainSCAN Software UserGuide

GENERAL INFORMATION


Training & Documentation


2 HARDWARE OVERVIEW2.1 Brainlab Couchmount2.1.1 Preparing and Handling Couchmounts

Overview

The Brainlab couchmounts enable you to immobilize and accurately position the patient’s head.They are mounted to the couch top. There are three basic models of couchmount:

Couchmount Compatible with... Attachment Instructions

• Siemens ZXT• Elekta/Philips RAM• Varian ETR

Page 26

• Siemens ZXT Carbon Fiber Page 27

• Brainlab Imaging Couch Top / Varian Exact• Siemens TT-S

Page 28

Before you Begin

In order to ensure the safe use of the couchmount, take the following steps before use:• Use the rotary knobs (X, Y, Z, T) to bring the couchmount into the zero position (0°)• Remove all accessories (Phantom Pointer, etc.)• Ensure that every adjustment (X, Y, Z, T) operates without resistance and engages smoothly

with little or no free play

Important

The following apply to all couchmount and couchmount lite models:

The maximum load of all couchmounts is 25 kg.

Every time you attach the couchmount, verify that it is securely locked by trying to removeit (without unfastening it).

To prevent injury when attaching the couchmount to the couch or couch adapter, do notgrip the couchmount along the inner attachment interface.

HARDWARE OVERVIEW


Common Couchmount Features

①

⑩⑥

⑦

⑧⑨②

⑤④ ③

Figure 1

No. Component

① Fixation levers for the couch side rails (one below the holder and one to the side)

② T adjustment of the table tilt, Tilt

③ X rotary knob (transversal)

④ Y rotary knob (sagittal)

⑤ Z rotary knob (longitudinal)

⑥ Holes for attaching the couchmount adapter

⑦ Insertion points for attaching the Phantom Pointer (for non-Brainlab headring)

⑧ Lock for the X, Y adjustment

⑨ Lock for the Z adjustment

⑩ Side rail holder

Warranty Information

The couchmount component warranty (for usage under normal operating conditions) is valid forone year.NOTE: Brainlab is not liable for damages resulting from misuse, incorrect installation, accidents,or connections to devices or accessories not approved by Brainlab

Brainlab Couchmount


Adjusting the Couchmount

①

Figure 2 If you use the couchmount, follow these steps during adjustment:

Steps

1. Release each of the locks ① a quarter turn.

2. Adjust the X, Y, and Z axes on the couchmount using the rotary knobs. See page 23

3. Refasten the locks. This prevents further adjustment and provides additional positioningstability.

HARDWARE OVERVIEW


2.1.2 Siemens ZXT, Elekta/Philips RAM, and Varian ETR Couch Tops

Attaching the Couchmount

①

Figure 3

Steps

1. Ensure that no accessories obstruct placement of the side rail holder.

2. Loosen the rail fixation levers ①.

3. Slide the couchmount onto the couch’s side rails.

4. Tighten the lower, then the upper fixation levers on the couch’s side rails. This ensuresthat the couchmount is always attached in the same position.

Detaching the Couchmount

To remove the couchmount, loosen the fixation levers and slide out the couchmount.

Brainlab Couchmount


2.1.3 Siemens ZXT Carbon Fiber Couch Top


①

②

③

Figure 4

Steps

1. Loosen the lower and upper fixation levers ① by approximately 2 mm.

2. Twist the lower blocks ②completely outward.

3. Lower the couchmount onto the couch’s side rails ③. The notches on the couchmountshould fit directly over each side rail.

4. Twist the lower blocks ② inward until they fit securely against the side rails.

5. Refasten the lower and upper fixation levers ①.


To remove the couchmount:• Loosen the upper and lower fixation levers by approximately 2 mm and twist the lower blocks

completely outward.• Slide out the couchmount.

HARDWARE OVERVIEW


2.1.4 Varian Exact and Siemens TT-S Couch Tops

Overview

The Couchmount Brainlab Imaging Couch Top / Varian Exact (Figure 5, left) andCouchmount for Siemens TT-S (Figure 5, right) vary mainly in that the latter does not havefastening screws. The Couchmount for Siemens TT-S is also more compact and somewhatsmaller.NOTE: The two fastening screws for the Couchmount Brainlab Imaging Couch Top / VarianExact are only required if used with the Couch Adapter for Imaging Couch Top. Otherwise,they must be removed.

②

①

③

Figure 5

No. Component

① Fastening screws

② Status indicator

③ Locking mechanism

Locking Mechanism

The couchmount may only be used for treatment if the status indicator is completely green,i.e., the automatic locking mechanism is completely engaged.

Keep fingers clear of the locking mechanism.

Brainlab Couchmount



③

④

Figure 6

Steps

1. Ensure that the status indicator (② on Figure 5) is red.

2. Lower the back of the couchmount onto the hooks (③ on Figure 6) on the couch.

3.Lower the bottom of the couchmount until it sits flushly against the couch. The lockingbolt ④will automatically engage and secure the attachment. The status indicatorshould be green.


⑤

Figure 7

Steps

1. Press and hold the button ⑤ on the side of the couchmount to disengage the automat-ic locking mechanism.

2. While still holding down the button, tilt the bottom of the couchmount away from thecouch.

3. Let go of the button and lift the couchmount off the couch.

HARDWARE OVERVIEW


2.1.5 Couchmount Lite

Overview

The couchmount lite can be used as an alternative to the normal couchmount. It does not allowpositioning of the patient; this must be done via the couch mechanism.

Figure 8

Mounting the Couchmount Lite

The couchmount lite is mounted the same way as the couchmount (page 26 to 28).

To prevent injury when attaching the couchmount lite to the couch or couch adapter, donot grip the couchmount lite along the inner attachment interface.

The maximum permitted load is 25 kg.

Once the couchmount lite has been attached, verify that it is securely positioned byattempting to remove it without opening the locking mechanism.

Notes for the “Imaging Couch Top / Varian Exact”

The couchmount lite may only be used for treatment if the status indicator is completelygreen, i.e., the automatic locking mechanism is completely engaged.

Keep fingers clear of the locking mechanism.

Brainlab Couchmount


2.2 Couchmount Adapters2.2.1 Couchmount Adapter Types

Overview

Brainlab provides special couchmount adapters for various stereotactic headrings. Theseadapters are attached via attachment holes to the couchmount. (See page 24)

Couchmount Adapter Types

① ② ③

⑤④

Figure 9

No. Component

① Couchmount Adapter for Brainlab Headring

② Couchmount Adapter for Radionics Headring

③ Couchmount Adapter for Leksell Headring

④ Tilt screw

⑤ Couchmount Adapter Brainlab Headring (for Elekta Couch)

Tilt Screw

The tilt ④ may only be adjusted after the mounting screws have been loosened.NOTE: Ensure that the couchmount adapter is correctly and securely mounted to the couchmountand cannot be unintentionally removed during treatment.

HARDWARE OVERVIEW


2.2.2 Couchmount Adapters: Brainlab Headring Models

Overview

When using an Elekta couch, choose your couchmount adapter by the location of the lesion. Thefollowing couchmount adapters (see Page 31) are available for use with the Elekta couch:• Couchmount Adapter Brainlab Headring for lesions on the lower head, between +30 mm

and +110 mm in the cranial direction. This adapter extends further in the longitudinal directionto compensate for the limited movement of the couch.

• Couchmount Adapter Brainlab Headring (for Elekta Couch)for lesions of the upper head,between -50 mm and +30 mm in the cranial direction. This adapter moves the treatment areaby 11.5 cm in the cranial direction (if the Elekta couch has already been completely movedtowards the foot end).

NOTE: The values are read from the vertical coordinate on the Stereotactic Target Positioner.

Treatment Areas

① ②

③

Figure 10 The above figure shows the treatment areas ③when using the Couchmount Adapter BrainlabHeadring ①and Couchmount Adapter Brainlab Headring (for Elekta Couch)②.

Couchmount Adapters


2.3 Collimator Mount2.3.1 Overview

Background

The Collimator Mount, in conjunction with various conical collimators, supplements the internalLinac X-Y jaws to shape the beam with steep-dose gradients for stereotactic radiosurgery/radiotherapy treatments.

Components (Shown: Mount for Varian Linacs)

⑤

①

②

③

④

③

Figure 11

No. Component

① Collimator

② Fixation ring

③ Fixation screws

④ Enclosure

⑤ Front screw tab

HARDWARE OVERVIEW


2.3.2 Attaching the Collimator Mount

Background

The collimator mount must only be used with the specific LINAC for which it was accepted.

Never change the collimator mount while a person is beneath the collimator mount.

After installing the collimator mount on the Linac, do not perform any Linac modificationsthat could alter the distance between the source and collimator mount.

Attaching the Collimator Mount (Siemens/Varian)

Steps

1. Position the gantry at 90°(270°) (according to the IEC 61217 scale).

2. Turn the Linac collimator so that the accessory tray slot opening points upward at anangle of 225°(45°) (according to the IEC 61217 scale).

3. Unscrew the two fixation screws (③ on Figure 11).

4.Slide the collimator mount completely into the accessory tray slot. Make sure that thefront screw tab ⑤ points outward when the collimator mount is inserted.This is the only way the collimator mount can be inserted.

5.Make sure that the accessory locking mechanism of the Linac is engaged.Refer to the Linac manufacturer’s manual for further information on attaching/detach-ing accessories.

6.• With the fixation screws open, carefully try to remove the locked collimator mount

from the accessory holder.• The locks must work effectively so that removal is not possible.

7. Once you are sure that the accessory locking mechanism of the Linac is properly en-gaged, firmly tighten both fixation screws by hand.

Further Information

Please refer to the Linac manufacturer’s manual for further information on attaching/ detachingaccessories. The base plate of the collimator mount as well as the accessory locking mechanismvaries depending on the manufacturer of the Linac.

Collimator Mount


2.3.3 Detaching the Collimator Mount

Background

Never change the collimator mount while a person is beneath the collimator mount.

Detaching the Collimator Mount (Siemens/Varian)

Steps

1. Position the gantry at 0°/180° (according to the IEC 61217 scale).

2. Remove the conical collimator (see Page 43).

3. Turn the Linac collimator so that the opening of the accessory tray slot points towardsyou.

4. Unscrew the two fixation screws (③ on Figure 11).

5. Make sure that the accessory locking mechanism of the Linac is released.

6. Slide the collimator mount completely out of the accessory tray slot and remove it.

Further Information

Please refer to the Linac manufacturer’s manual for further information on attaching/ detachingaccessories. The base plate of the collimator mount as well as the accessory locking mechanismvaries depending on the manufacturer of the Linac.

HARDWARE OVERVIEW


2.3.4 Collimator Mount Siemens with Coded Plug

General Information

The Collimator Mount Siemens with coded plug supports the Siemens accessory code ST5VAR.The linac X-Y jaw field is thereby restricted to a maximum of 5.3cm x 5.3cm.

Components

③ ④ ⑤ ⑥

①②

Figure 12

No. Component

① Collimator

② Fixation ring

③ Enclosure

④ Fixation screws

⑤ Bevelled corner

⑥ Coded plug

Collimator Mount


Coded Plug

As shown in Figure 13, the coded plug has four resistors integrated that generate the Siemenscode ST5VAR at the Linac console.

Figure 13

The LINAC Console Software must be able to support “ST5VAR” that allows the jaws to beto set to a maximum field size of 5.3cm x 5.3cm.

Compatibility Table

Only use the Collimator Mount Siemens with coded plug on LINACs that fulfill allrequirements listed in the compatibility table below.Collimator Mount Siemens with coded plug (BL Art. No: 40500-10B) requires:

Requirement Specification

linac Console Software Version 12.0 or higher

Record and Verify System Syngo RT Therapist 4.2 or higher

linac Types

• Siemens PRIMUS with 3D-MLC (58MLC)• Siemens PRIMUS with OPTIFOCUS MLC (82MLC)• Siemens ONCOR with 3D-MLC (58MLC)• Siemens ONCOR with OPTIFOCUS MLC (82MLC)• Siemens ONCOR with 160 MLC• Siemens Artiste

ManufacturerSiemens AGWittelsbacherplatz 2Muenchen, Germany

Settings

During installation the following settings must be made by the support specialist to ensure thecorrect functioning of the Collimator Mount Siemens with coded plug.• In the Beam Profile Editor/Physics Administration, the Cone ID Format String must be set

to ST5VAR to ensure that this code is always sent for circular cone treatments.• In the iPlan RT Dose Export Platform file the circular arc definition must be set to Block.

HARDWARE OVERVIEW


Do not use the Collimator Mount if the Collimator Mount, or part of it, is damaged orwarped.

Make sure that the coded plug does not come into contact with moisture or fluids as theelectronic parts might be destroyed or damaged.The Collimator Mount Siemens with Coded Plug is classified IPX0 according to IEC 60529.

How to Attach the Collimator Mount

Steps

1. Position the gantry at 90° (270°) (according to the IEC 61217 scale).

2. Turn the linac collimator so that the accessory tray slot opening points upward at an angleof 225° (45°) (according to the IEC 61217 scale).

3. Unscrew the two fixation screws ④ so that they do not protrude.

4.Slide the collimator mount completely into the accessory tray slot. Make sure that the sidewith beveled corners is inserted first. This is the only way the collimator mount can be at-tached securely.

5. Make sure that the accessory locking mechanism of the Linac is engaged. Refer to thelinac manufacturer’s manual for further information on attaching/detaching accessories.

6.With the fixation screws still open, carefully try to remove the locked collimator mountfrom the accessory holder. The locks must work effectively so that removal is not possi-ble.

7.Once you are sure that the accessory locking mechanism of the Linac is properly engag-ed, push down the Collimator all way down again and then firmly tighten both fixationscrews by hand.

Safety Notes

Never change the Collimator Mount while anyone is beneath the Collimator Mount.

When using the Collimator Mount Siemens with coded plug, use a Conical Collimator ofmaximum ø 45mm field size for treatment.

After installing the Collimator Mount on the Linac, do not perform any Linac modificationsthat could alter the distance between the source and collimator mount.

Verify for every treatment field that the correct, intended conical collimator - as specified inthe treatment parameter printout - is actually mounted to the Collimator Mount.

Prior to each treatment make sure that the coded plug of the Collimator Mount is detectedcorrectly. Siemens code “ST5VAR” must be detected.

Prior to each treatment field always make sure that the correct LINAC Jaw settingsaccording to the Treatment Planning are set up.

Every modification/update or change of the LINAC Console Software, of the R&V system orany other LINAC system components that might have effect on the LINAC coding requiresa diligent checkup of the correct function/ detection of the coded plug.

Be aware that “ST5VAR” detection does not provide a verification or detection of ConicalCollimator.

Collimator Mount


If the coded plug had to be removed due to insufficient system requirements there is noautomatic restriction of the primary jaw field.

How to Detach the Collimator Mount

Steps

1. Position the gantry at 0°/180° (according to the IEC 61217 scale).

2. Remove the conical collimator (see page 43).

3. Turn the Linac collimator so that the opening of the accessory tray slot points towardsyou.

4. Unscrew the two fixation screws ④.

5. Make sure that the accessory locking mechanism of the linac is released.

6. Slide the collimator mount completely out of the accessory tray slot and remove it.

HARDWARE OVERVIEW


2.3.5 Third-Party Labels on the Brainlab Collimator Mount

General Information

Brainlab has authorized users and third-party linear accelerator manufacturers to attach labels tothe Brainlab Collimator Mount. Brainlab warrants that the terms of Brainlab warranty of service,where applicable, will not be affected if the instructions below are followed.

Placing Labels

Those labels may only be placed within the area depicted in Figure 14:

Figure 14

Safety Notes

The applied label may only be placed at the Collimator Mount within the specified area.

Make sure that the applied label does not hinder safe and rigid attachment of theCollimator Mount to the LINAC.

The surface of the Brainlab Collimator Mount is nickel-plated. If the labeling requiresspecial surface preparation, make sure to use a suitable cleaning agent.

Brainlab does not assume responsibility for the correct functioning of a non-Brainlab LinacAccessory Identification System.Brainlab excludes any liability resulting from a mismatch between the customer label or third-partylabel and the Brainlab Collimator Mount.For further information related to the non-Brainlab Linac Accessory Identification System pleasecontact the manufacturer directly.

Collimator Mount


2.3.6 Using Conical Collimators

Background

Never change the collimator while a person is beneath the collimator mount.

Components

① ②

③④

Figure 15

No. Component

① Installation groove

② Security pin

③ Snap-in groove

④ Tab

HARDWARE OVERVIEW


Circular Field Size

The engraved cipher ① on the collimator specifies the circular field size ø (mm) in the isocenter.

①

Figure 16

How to Attach the Collimator

Brainlab recommends positioning the gantry at 180° (according to the IEC 61217 scale).

Steps

1.

Align the collimator with the collimator mount. The blue lines on both componentsshould be aligned.

2.

Insert the collimator flush into the collimator mount and turn it clockwise until the secur-ity pin snaps into place.

3.

Screw the fixation ring (② on Figure 11) in securely.

Collimator Mount


How to Remove the Collimator

Brainlab recommends positioning the gantry at 180° (according to the IEC 61217 scale). Toremove the collimator:

Steps

1. Unscrew the fixation ring.

2. While firmly holding the collimator, press the security pin (④on Figure 15) towards itscenter to open the locking mechanism.

3. Rotate the collimator counterclockwise, then pull it away from the collimator mount.

Collimator Cross-section

①

②

③

③

③

Figure 17

No. Component

① Bronze casing

② Lead core

All distances marked with ③ are measured from the radiation source.

Safety Notes

Make sure the security pin is locked before reinstalling the fixation ring. Prior to anytreatment, apply all relevant quality assurance procedures to ensure that the collimatormount is properly positioned. See page 89

Make sure that the security pin is snapped in when removing the fixation ring. Only in thisposition can it be guaranteed that the collimator is securely attached and that the fixationring can be removed without risking the collimator falling off.

HARDWARE OVERVIEW


Verify a secure and rigid fixation of the collimator within the collimator mount before use

When using conical collimators the LINAC jaws have to shield the radiation outside thelead core.

Be aware that the positioning accuracy of the LINAC jaws can vary depending on the typeof LINAC used.

The LINAC jaw positions used during treatment must be identical to the LINAC jawpositions used during beam measurements.

Ensure that the LINAC jaws do not overlap the circular collimator opening.

To avoid unintended leakage radiation using conical collimators the LINAC jaw size mustbe smaller or equal 56x56 mm² for all Linacs except for Novalis classic.

Verify for every treatment field that the correct, intended conical collimator is actuallymounted to the LINAC, especially if a treatment plan contains treatment fields with differentconical collimator sizes.

Ensure that any treatment accessories, such as conical collimator mount and conicalcollimator of the size which is required by the treatment plan, are installed properly in thebeam path before delivery. Your treatment delivery systems may not be able to assert abeam interlock in case of missing or wrong accessories. Also refer to the documentationprovided for the Brainlab Treatment Planning System.

Do not to use a higher photon energy than 25 MV for treatments.

Operate the LINAC with photons only when using conical collimators.

Collimator Diameters and Jaw Sizes

Verify by inspection that the area outside the shielded lead core of the conical collimator iscompletely covered by the jaws. The models and range of conical collimator apertures differsignificantly. For Brainlab conical collimators, to avoid radiation outside the conical collimator orleakage at the edge of the field resulting from potential set-up inaccuracies (mechanical collimatoralignment, jaw positioning, and other tolerances), Brainlab recommends using the jaw settingslisted in the table below. If properly implemented, these settings will aid in keeping the jaw shapedfield size tight around the largest conical collimator.

Brainlab conical collimators used with all LINACs including Novalis Tx, but not includingNovalis

Diameter of largest conical collima-tor in use at site [mm]

Recommended size of jaw-shaped field for all conical col-limators [mm²]

up to 7.5 14 x 14

8 14 x 14

10 16 x 16

12.5 18 x 18

14 20 x 20

15 20 x 20

16 22 x 22

Collimator Mount


Brainlab conical collimators used with all LINACs including Novalis Tx, but not includingNovalis

17.5 24 x 24

18 24 x 24

20 26 x 26

22 28 x 28

22.5 28 x 28

24 30 x 30

25 30 x 30

26 32 x 32

27.5 34 x 34

28 34 x 34

30 36 x 36

32 38 x 38

32.5 38 x 38

35 40 x 40

36 42 x 42

37.5 44 x 44

40 46 x 46

42.5 48 x 48

45 50 x 50

50 56 x 56

Verifying the Jaw-Shaped Field

The jaw-shaped field must be symmetric to the central beam axis and the identical jaw positionhas to be used for all conical collimators. If you intend to modify the jaw positions after the initialbeam data acquisition, you should determine to which degree the adjustment of jaw positionsrequires re-measurement of certain beam profiles.Regardless of the jaw-shaped field size in use, Brainlab recommends using a suitable film test toverify and document the complete shielding outside the intended center beam through the conicalcollimator.

HARDWARE OVERVIEW


2.3.7 Third-Party Labels on Brainlab Collimators

General Information

Brainlab has authorized users and third-party linear accelerator manufacturers to attach labels tothe Brainlab Conical Collimators. Brainlab warrants that the terms of Brainlab warranty or service,where applicable, will not be affected if the instructions below are followed.

Placing Labels

Those labels may only be placed within the area depicted in Figure 18.

Figure 18

Safety Notes,

The applied label must not cover any original markings of the Brainlab Conical Collimator.

The surface of the Brainlab Conical Collimators is nickel- plated. If the labeling requiresspecial surface preparation, make sure to use a suitable cleaning agent.

Brainlab does not assume responsibility for the correct functioning of a non-Brainlab ConeIdentification System.Brainlab excludes any liability resulting from a mismatch between the customer label or third-partylabel and the Brainlab Conical Collimator size.Brainlab requires that Brainlab Conical Collimators on Varian LINACs are used only incombination with a cone verification system or process (e.g. Varian BCCV).

Collimator Mount


3 IMMOBILIZATIONHARDWARE

3.1 Stereotactic Headring3.1.1 Overview

Overview

The Stereotactic Headring is an invasive stereotactic fixation system. It prevents the patient’shead from moving and minimizes errors during patient setup. Only one screw needs to beloosened to adjust the headring for the patient’s anatomy.The Stereotactic Headring is a hardware component that is used for invasive patientimmobilization with highest positioning accuracy. It is used for CT or x-ray scan procedures as wellduring single fraction radiotherapy or radiosurgery treatments. The main frame of the Headring isfixed to the patient’s head in a rigid position by fixation pins which are screwed against the skull.

Figure 19 The Stereotactic Headring is for single fraction treatments only. It is not intended for multi-fractional treatment.

Do not use the Stereotactic Headring in an MR, PET, or SPECT environment.

Do not use the headring on patients under eight years of age.

IMMOBILIZATION HARDWARE


3.1.2 Stereotactic Headring Components

Torque Wrench

The torque wrench is provided to prevent the user from applying more than the desired torque tothe fixation pins. It offers a reliable method for applying reproducible and measurable force to apatient’s head. Two torque wrenches are included in the headring set.

①

Figure 20

No. Component

① Torque wrench

Headring Posts

Four carbon fiber headring posts are delivered with the headring and are optimized for stabilityand artifact-free diagnostic imaging. Each of the four posts is attached to the inside of theheadring using the screw at the bottom of the post. This form of attachment allows vertical andangular adjustment of each post.

①

Figure 21

No. Component

① Headring post

Stereotactic Headring


Fixation Pins

The reusable fixation pins are ceramic tipped and self-penetrating. They are designed for artifact-free CT imaging.

①

Figure 22

No. Component

① Fixation pins

The fixation pins may shatter if uneven or extreme torque is applied, or if less than fourfixation pins are used.

Do not combine Brainlab fixation pins with other brands of fixation pins.

The fixation pins must be tightened using a torque wrench adjusted to no more than 30Ncm, otherwise the pins or posts may be damaged.

If patients show indications of Creutzfeld-Jakob Disease (CJD) and are treated usingBrainlab fixation pins, these fixation pins must be disposed of directly after surgery toprevent microbiological contamination.

Headring

The Brainlab headring is used for cranial fixation and consists of an aluminum alloy.

①

③

②

④Figure 23



No. Component

① Holes for mounting localizer or Stereotactic Target Positioner (front of headring)

② Locks

③ Front piece

④ T-screws for attachment of couchmount adapter (back of headring)

Headring Front Piece

An aperture for the front piece ③ can be found on the anterior side of the headring. It consists oftwo parts: A straight piece and a curved piece. These allow for intubation access to the mouth andnasal areas. If necessary, the straight piece may be removed even if the headring is mounted onthe patient.



3.1.3 Attaching the Fixation Posts

Post Assembly Components

①②

③

④

⑤⑥⑦

Figure 24

No. Component

① Post fixator

② Sliding washer

③ Screw

④ Guidance piece

⑤ Fixation post

⑥ Sliding nut

⑦ Front piece

How to Attach the Posts

Steps

1. Place the sliding washer ② over the screw ③, then insert the screw into the corre-sponding hole on the outside of the headring.

2.

In the following order, slide the following onto the screw from the inside of the ring:post fixator ①, guidance piece ④, post ⑤, and sliding nut ⑥.NOTE: Install the short fixation posts on the posterior side of the headring, and thelong fixation posts on the anterior side. Otherwise, Brainlab cannot guarantee a securefixation.

3.Tighten the screws with the supplied Allen wrench.NOTE: Loosening the screws allows adjustment of the posts.



3.1.4 Adjusting the Torque Wrench

Overview

Adjust the torque wrench prior to tightening the fixation pins. The necessary torque will vary bypatient.The locking mechanism prevents the user from applying more than the adjusted torque value tothe fixation pins.

Set the torque wrench to the maximum desired torque to be applied before tightening thefixation pins. 30 Ncm is the maximum allowed setting.Torque wrench is delivered with a calibration certificate. The calibration is valid for one yearstarting with the first use of the device.Please also consider the instructions and safety information given in the instruction manual of thetorque wrench manufacturer.If the torque wrench is likely not to be used for a longer period of time, it is advisable to adjust it tothe minimum value for relaxation of interior parts such as the spring. Remember to readjust thetorque setting before treating the next patient.

Torque Wrench

⑥

① ② ③

④ ⑤

Figure 25

No. Component

① Locking ring

② Adjusting ring

③ Main scale

④ Adjustment screw

⑤ Grip

⑥ Bit with insert



How to Adjust the Torque Wrench

Before mounting the Headring to the patient's head, adjust the torque wrench to the maximumtorque applicable to the patient’s head by following steps 1 to 4.

Steps

1. Unlock the torque wrench, turning the black ring ① in the opposite direction to the en-graved arrow.

2.Adjustment of the torque wrench: Hold grip g and turn the adjustment ring ②to the valueyou want to set. (Main scale value + Adjustment ring scale value = Torque Value) (e.g. 30Ncm, Fig. B).

3.Lock the torque wrench by turning the black ring ①in the direction of the arrows until itengages. Now the torque wrench is properly adjusted. Turning the torque wrench clock-wise prevents you from applying more than the adjusted torque value to the Fixation Pins.

4. Finally, mount the bit with insert h which connects your Fixation Pins to the tip of the tor-que wrench. Be sure to insert the bit securely as far as it goes.

NOTE: If the torque wrench will not be used for an extended period of time, set the adjustmentring to “0 Ncm.” This relaxes the internal spring tension mechanism.



3.1.5 Affixing the Stereotactic Headring to the Patient

Before You Begin

Thoroughly review the patient’s records and image data to ensure that no parts of the skull caphave been removed during previous brain operations.The posts should be attached to the headring, but to avoid injuring the patient, no fixation pinsshould be inserted at this point.Quality assurance is an important part of every treatment and therefore should be applied prior tosetup of the patient (See page 89).

Notes on Headring Positioning and Fixation

• A sitting position may ease headring fixation. The patient's neck should be in a neutral positionfacing forward. Although not recommended, the patient can also be in a supine, non-rotatedposition, while the surgeon supporting the patient's head. Under conditions of generalanesthesia, the latter approach is occasionally required.

• The headring is normally at a 0-10° angle to the patient's eyes, with the superior rim positionedat or slightly inferior to the tip of the nose. The superior rim of the headring should be at least15 mm below the target area to ensure correct CT scanning access and target localization.

• On the front of the head, pins are generally positioned to either side of the sinuses. Duringheight adjustment ensure that the pins are fixated well above the eye sockets and below thehairline (joint of face and cranium). If the pins are positioned too high, they can easily shift dueto the curvature of the skull. Pins should be fixated above the lateral sinus to avoid shifting ofthe pins. Moreover, they should be placed medial of the lateral part of the lambdoid suture.

Warnings: Fixation Pins

Do not use pins that are too long. Make sure the selected fixation pins permit the localizerto fit onto the headring.

The fixation pins must be tightened using a torque wrench adjusted to no more than 30Ncm, otherwise the pins or posts of the headring may be damaged.

No fixation pins should be inserted into the posts while the headring is being secured, asthe extremely sharp tips of the self-penetrating fixation pins could severely injure thepatient.



How to Affix the Stereotactic Headring

①

②

③

④

Figure 26

Steps

1. Position the headring onto the (sitting) patient using the velcro strap.

2. Loosen the locking screws of the posts to enable adjustment.

3.Remove the headring temporarily to prepare the pin sites.NOTE:The surgeon is responsible for maintaining appropriate care of the pin sites.They should be shaved and cleaned using a disinfectant.

4.Local anesthesia may be applied after replacing the headring at its final position.NOTE:Generally, local anesthesia is applied through the threaded holes of the posts.This insures that the projected pin entry sites are properly anesthetized.

5. Cover the tips of the pins with an antibacterial or iodine-enriched ointment.

6. Insert the pins into the posts pointed downward, toward the skin.

7. Verify that the headring position is correct.

8. Carefully tighten the pins until they penetrate the bone.

9.

Tighten the fixation pins crosswise, one after the other, and not more than one revolu-tion at a time (see Figure 26 for pin tightening order) to avoid lateral forces to the otherpins.NOTE:Only use torque wrenches delivered with the headring to tighten the fixationpins with a reproducible and measurable force. This prevents the user from applyingtoo much torque to the fixation pins.

10. Remove the velcro strap.

Warnings: Fixation Accuracy

Position the headring so that the localizer does not disturb the patient’s nose.

If the patient moves when fixed to the headring and applies force to the device, the fixationis no longer accurate.



Never remove both front pieces simultaneously while the headring is attached to thepatient’s calvarium.



3.2 Stereotactic Mask System3.2.1 Mask System Components

Overview

The non-invasive Stereotactic Mask System enables precise and easily repeatable patientfixation for cranial stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS). The mask,constructed from thermo-transformable material, is individually molded for each patient andsecured to the mask ring.

The mask may cause mild irritation to patients with sensitive skin.

General Components

①

②

③

④

⑤⑥

Figure 27

No. Component

① Headrest

② Mask ring

③ Screw

④ Cam locks

⑤ Vertical posts

⑥ Vertical post positions (letters)



Mask Set

①

② ③

④

⑤

Figure 28

No. Component

① Top and rear masks (interchangeable)

② Middle mask

③ Dental support strip

④ Loose pellets

⑤ Mesh

Mask Set Accessories

①

②

③ ④ ⑤

⑥

⑦

Figure 29



No. Component

① Vertical posts, Low Frame

② Vertical posts

③ Blank clips

④ S clips

⑤ 0 - 4 mm clips

⑥ 1 - 4 mm spacers

⑦ T screws

Set for Low Mask Fixation

The Set for Low Mask Fixation is intended for inferior lesions. The vertical posts and headrestcontained in this set replace the corresponding parts of the standard set and allow a lower fixationof the patient's head.

Figure 30

Be aware that there are two different mask system designs and corresponding components(mask ring, headrest, vertical post). Never interchange the Standard Mask Fixation with theLow Mask Fixation. If you intend to interchange mask systems of identical design, youmust verify the compatibility by checking the accuracy, e.g., by performing a phantomtreatment to the same target point on all mask systems.



3.2.2 Molding the Mask

Before you Begin

Steps

1. Have patients remove all items from their heads (toupee, false teeth, hearing aid, ear-rings, etc.).

2. Heat a water bath to 70° - 80°C (158° - 176°F).

3. As the material can stick to porous surfaces after activation, covering the patient’s hairwith plastic foil is recommended.

4. Line up all necessary clips and spacers.

5. Position the vertical posts at ear height.

6. Place the head of the patient into the mask ring and onto the headrest, so that theback of the head rests comfortably on the headrest.

NOTE: If the patient's head is too large or has anatomical abnormalities, the posts may beadjusted to a different level. Usually, the positions of the vertical posts do not need to be changed(position C and U; see ⑥onFigure 27).

Always mount the vertical posts to the mask ring before mounting the mask to the verticalposts.

If lesions or open wounds are present on the patient’s face, cover them using plastic wrapor adequate dressings before you mold the mask.

If the temperature of the softened mask is too high, the patient may suffer skin irritations orburns.

How to Mold the Rear Mask

Figure 31

Steps

1. Place the rear mask in the heated water bath until the mask becomes transparent (ap-proximately 40 to 60 seconds).

2. Remove the mask from the bath and place it on a towel to dry.



Steps

3. Before proceeding, test the temperature of the softened mask to ensure the patient'scomfort.

4. Lift the patient's head and snap the mask onto the upper side of the vertical posts.

5. Lower the patient's head onto the headrest (Figure 31, left).

6. Gently mold the material to the contour of the patient's head as the mask materialhardens (Figure 31, right).

How to Mold the Middle Mask

Figure 32

Steps

1. Place the middle mask in the heated water bath until the mask becomes transparent.This mask may take longer to heat than the rear mask.

2.Place the 2 mm spacers onto the vertical posts.Always align the shape of the spacers with the shapes of the vertical posts. The notchmust be on the outer side, so that the clips fit into the notch.

3. Remove the mask from the bath and place on a towel to dry.


5.Place the mask on the center of the patient's face.The wider strip is placed just above the patient's eyebrows and the narrow strip isplaced just beneath the patient's nose, but above the mouth.

6. Stretch the mask carefully and evenly towards the vertical posts.

7. Snap the mask onto the vertical posts and secure it with the S clips.

8. Use your fingers to gently mold the mask to the patient's facial contours.



How to Mold the Nose Bridge

Figure 33

Steps

1. Place the loose pellets onto the mesh sheet provided with the mask set (④ and ⑤ onFigure 28, respectively), then into the water bath.

2. After the pellets have become transparent, remove them from the water bath.

3. Roll them in your hand to create an oval form (Figure 33, upper left), then shape themwith your fingers to create a t-shaped form (Figure 33, lower left).

4. Place the form on the bridge of the patient's nose and gently flatten it.

5.Gently mold the nose bridge towards the strip on the forehead and down towards theeyes, going no closer than 3 mm to the eyes (Figure 33, right).For the best connection, the middle mask should still be transparent when molding.

6. Let both the middle mask and nose bridge completely harden.

How to Mold the Dental Support Strip (Optional)

Steps

1. Place the dental support strip (③onFigure 28) into the water bath.

2. When the strip becomes transparent, remove it from the water bath.

3. Before proceeding, test the temperature of the strip to ensure the patient's comfort.

4. Attach the strip to the middle mask.

5. Bend and fold the strip over the patient's upper lip and press it onto the front teeth andgums. Don't form the strip around the front teeth.



How to Mold the Top Mask

Figure 34

Steps

1. Remove the clips from the vertical posts.

2. Place the top mask (④ on Figure 28) in the water bath until it becomes transparent.

3. Remove the mask from the bath and place on a towel to dry.


5. Place the mask centrally over the patient’s face ensuring that the curve in the mask isplaced towards the patient’s mouth.

6. Stretch the mask carefully and evenly towards the vertical posts.

7. Snap the mask onto the vertical posts and secure it with the 2 mm clips.

8. Gently contour the mask onto the patient’s face. Make sure that the sides attached tothe vertical posts are also molded to fit onto the patients face.



Hardening Process

Figure 35 The duration of the hardening process largely depends on the conditions (temperature andhumidity) under which the mask has been molded.• Always allow the material enough time to completely harden in order to avoid shrinkage of the

mask.• The material is no longer shapeable when it is completely white and opaque.• The mask should harden for at least 30 minutes after it turns completely white.• Dispose of the scraps in containers for burnable waste.



3.2.3 Removing and Reattaching the Mask

Before you Proceed

Be sure to record the appropriate size of the spacer, size of the clips and the name of thepatient on the provided sticker and attach it to the mask, to avoid mistakes when refittingthe mask.

Never open the screws that mount the vertical posts to the mask ring if the mask hasalready been placed on the patient and is secured with the clips.

If the patient moves when fixed to the Brainlab mask system and applies force to thedevices, the fixation is no longer accurate.

How to Remove the Mask

Steps

1. Make sure the mask has hardened sufficiently (See page 64).

2. Remove the clips.

3. Remove the top, then middle masks.

How to Reattach the Mask

Steps

1. Mount the vertical posts to the mask ring.

2. Affix the rear mask to the vertical posts.

3. Lower the patient’s head onto the rear mask.

4. Reattach the middle mask, then the top mask.

5. Secure the mask with the respective clips to the vertical posts.

How to Adjust Mask Fit

The Stereotactic Mask System can be tightened or loosened (e.g., if the patient has lost weight).To adjust the fit of the mask, use the following procedure:

Steps

1. Remove the 2 mm clips and the top and the middle mask (the top two layers).

2.Replace the 2 mm spacer:• with the 1 mm spacer to tighten mask fit. To tighten further, remove the 1 mm spacer.• with the 3 mm or 4 mm spacers to loosen mask fit.

3. Place the two sheets back in their former position and secure them with the new clips.

Mask Thickness

The thickness of the material will vary depending on the size of the patient's head and thetechnician’s ability to produce an evenly-stretched mask. The density of the material isapproximately 1.15 g/cm3 at room temperature and 1.06 g/cm3 at body temperature, making itessentially tissue equivalent.



Treating through 3.2 mm material (with no less than 6 MeV) can be done without significantirritation of skin. If the treatment is performed with static fields rather than convergentarcs, we recommend avoiding the double-layer areas of the mask with the beam path ifskin irritation starts to occur.



3.3 Upper Jaw Support3.3.1 Components

Overview

The Upper Jaw Support is an optional accessory of the Stereotactic Mask System. It isdesigned to reduce the longitudinal movement of the patient by referencing his upper jaw position.

Key Components

②

①

③④

Figure 36

No. Component

① Joints for mask ring

② Allen screws

③ Reference plate (shown: Reference Plate Medium)

④ Hand screw

Reference Plates

① ② ③

Figure 37

No. Component

①The Reference Plate Medium is intended for standard cases. As this reference platecan be inserted into the holder from both directions, it has a wide range of implementa-tion. It is marked with a ① on the top of the plate.



No. Component

②The Reference Plate Small should be used when the patient’s upper jaw is locateddirectly below the hand screw for the fixation of the reference plate; it is marked with a② on the top of the plate.

③ The Reference Plate Long should be used with the Set for Lower Mask Fixation; itis marked with a ③ on the top of the plate.

Complete Contents

Each Upper Jaw Support is delivered with the following components:• 1 Upper Jaw Support• 2 joints for mask ring• 2 allen screws• allen wrench• 2 Reference Plates Medium• 2 Reference Plates Small• 2 Reference Plates Long• 1 sterilization tray• 1 package silicone disposables• Fixation screws and tools

Upper Jaw Support


3.3.2 Attaching the Upper Jaw Support

Before You Begin

Verify the positioning of the reference plate before molding the mask, as it must be directlyadjacent to the patient’s upper jaw.Patients with false teeth/dentures should remove them before attaching or adjusting the referenceplate.

Avoid collision with the patient’s teeth, nose or lips when attaching the Upper Jaw Support.

How to Attach the Upper Jaw Support

Figure 38

Steps

1.Attach the Upper Jaw Support to the mask ring using the screws provided.Make sure the “A” and “S” engraved on the Upper Jaw Support are aligned with thecorresponding engravings on the mask ring.

2. Select the appropriate reference plate. It should be able to reach the patient’s upperjaw.

3.Slip the silicone disposable over the reference plate. The lower part of the U-shapeddisposable should be towards the patient’s upper teeth/palate.NOTE: The silicone disposables are hygienic devices designed for single use only.

4.Adjust the hand screw (④ on Figure 36) so that the reference plate is positioned di-rectly below the upper jaw of the patient. This should prevent longitudal movement ofthe head.



Reference Plate Settings

Figure 39 Take note of the scale setting of the reference plate following adjustment. Always read the settingson the side of the scale (see Figure 39).Because the plates can be mounted in both directions, it is necessary to record the side of theUpper Jaw Support (A or B) from which the scale has been read.

Always transfer the scale value and the indication letter, as well as the number of thereference plate which was used, to the patient's folder to prevent errors in patientpositioning.

Readjusting the Reference Plate

To readjust the reference plate for subsequent fractions, use the data noted in the patient's folderfrom the initial setup and adjustment.

Make sure that the correct side and position of the reference plate are used to avoidincorrect positioning of the patient.

Upper Jaw Support


4 IMAGING4.1 Imaging with the Headring and Mask System4.1.1 Localizer Design

Overview

A localizer is mounted to the headring or the mask system for imaging. The localizer’s 210 mmscanning range allows the entire head to be scanned and localized, which is especially importantfor inferior lesions.The localizer is intended for CT scanning and/or x-ray imaging. It defines a precise, stereotactic,three-dimensional coordinate array within a patient’s cranial volume (necessary for preciseradiosurgery or stereotactic biopsy procedures).

Types of Localizers

Depending on the type of headring and mask system used, there are two localizers available.These localizers differ only in their fixing mechanism (i.e., ball feet or alignment pins).• CT/X-Ray Localizer• CT/X-Ray Localizer for Leksell Headring

Localizer Design

①

②

④

③

Figure 40

No. Component

① PVC localizer rod

② Copper square in x-ray inserts

IMAGING


No. Component

③ Holding spigot

④ Holding screw

PVC Localizer Rods

Six PVC localizer rods ① are embedded into the acrylic glass of the localizer. In the axial CTimages, they are visible as six index markers. These markers provide the geometric matrix fordetermining the exact position of any structure relative to the headring and mask system.

X-Ray Inserts

Four copper squares ② are built into the localizer plates. For each x-ray image, one pair of thecopper squares are used to localize structures in relation to the headring. These inserts enableplanar projection x-ray and stereotactic localization in angiography.

Removing the X-Ray Inserts

If you find artifacts in CT images, remove the x-ray inserts.

Steps

1. Unscrew the holding screw ④ using a small screwdriver.

2. Remove the x-ray insert.

Reattaching the X-Ray Insert

To reattach the x-ray insert:• Place the lower edge of the insert into the holding groove at the bottom of the localizer plate.• Refasten the holding screw at the top of the x-ray inserts.

Imaging with the Headring and Mask System


4.1.2 Attaching the Localizer

How to Attach the CT/X-Ray Localizer

Before scanning the patient, take the following steps:

Steps

1. Place the patient on the imaging couch in a supine position.

2.

Attach the CT/X-Ray Localizer to the Brainlab (or the Radionics BRW) headring, orthe Stereotactic Mask System.The three ball feet of the localizer should fit precisely into the locks of the Brainlabheadring or mask system. The localizer cannot be incorrectly mounted due to theasymmetrical arrangement of the fixing mechanism.NOTE: Once the localizer has been mounted onto the headring or mask system, theplate marked with a “R” is on the right side of the patient’s head, while the platemarked with an “A” is on the frontal calvarial part of the patient’s face.

Do not use the CT/X-Ray Localizerif the fixing mechanism does not fit exactly into the locksof the headring/mask system or if the locks can not be fastened correctly.

How to Attach the CT/X-Ray Localizer for Leksell Headring

The CT/X-Ray Localizer for Leksell Headring can only be used with the Leksell G-frameheadring. Instead of ball feet it has four alignment pins that fit onto the Leksell headring.Otherwise, the procedure for attachment is nearly identical.

To ensure an accurate imaging, objects should not be inserted between the Leksell G-frame headring and the CT/X-Ray Localizer for Leksell Headring.

Only use the CT/X-Ray Localizer for Leksell Headring if it can be firmly secured to theLeksell G-frame headring.

How to Position the Localizer

Always position the localizer perpendicular to the axes of the scanner couch and the gantry, topermit scanning the CT slices in the desired thickness and configuration.Generally the localizer is put on the localizer support during the scan for proper positioning.Following image acquisition, the patient may leave the scanner and be transferred to theprocedure area. In the meantime, the scan data may be analyzed and transferred to theBrainSCAN or iPlan RTtreatment planning system.NOTE: When using the localizer in combination with any compatible headring, it is not necessaryto rigidly mount the headring to the CT couch, as the Brainlab treatment planning software cancorrect for small shifts during scanning.

IMAGING


Localization Procedure

Figure 41 To perform the x-ray localization, one sagittal and one coronal image of the head are required.The two copper squares must be entirely visible in both images. The user should also ensure thatthe corners of the squares are fully visible in the x-ray projection’s field of view, as shown in Figure41.For further scanning instructions and scan settings, please refer to the PatXfer user guide.

Verify that the images are not distorted if any form of digital imaging has been used.

The CT/X-Ray Localizer for Leksell Headring and the CT/X-Ray Localizer may only be usedwith a Brainlab treatment planning system.

Do not use the CT/X-Ray Localizer for Leksell Headring or the CT/X-Ray Localizer if it is anyway warped or damaged, or any of the parts are loose.



4.1.3 Angio Distortion Correction Module

Overview

The Angio Distortion Correction Module is a low density carbon fiber plate that can be attachedto either the CT/X-Ray LocalizerorCT/X-Ray Localizer for Leksell Headring. A grid of 294stainless steel spheres – each with a diameter of 2 mm – is embedded in its surface.

① ③

④②

Figure 42

How to Attach the Angio Distortion Correction Module

The Angio Distortion Correction Modulecan be fitted to the top or to either side of the localizer,depending on the location of the image detector.

Steps

1. Hold one pair of guiding hooks ② against the edge of a localizer plate ③.

2. Gently press the other side of the Angio Distortion Correction Moduleagainst the lo-calizer until it snaps into place ④. The module should sit flush against the localizer.

3. Ensure that the Angio Distortion Correction Module is facing the image detector.

IMAGING


Patient Alignment

Figure 43 Always mount the Angio Distortion Correction Module so that the patient icon (above) isaligned with the patient’s position.

Safe Handling

Never use the Angio Distortion Correction Module to lift the localizer.

If you accidentally drop the Angio Distortion Correction Module, return it to Brainlabsupport for verification.



5 POSITIONING FORTREATMENT

5.1 Stereotactic Target Positioner5.1.1 Overview

Overview

The Stereotactic Target Positioner fits onto the Stereotactic Headring or Stereotactic MaskSystem. It enables alignment of the patient’s isocenter with the wall lasers.

The Stereotactic Target Positioner may only be used with a Brainlab treatment planningsystem.

Radionics Compatibility

The Stereotactic Target Positioner can also be mounted to the Radionics BRW headring andthe Radionics UCHR-AP adapter for the UCHR headring.

Components

① ② ④

③

Figure 44

No. Component Explanation

① Target PositionerCarrier Plates One carrier plate is attached to each side of the target positioner.

POSITIONING FOR TREATMENT



② Stereotactic TargetPositioner Consists of an aluminum frame with room for four carrier plates.

③ Adhesive Tape Used to attach the overlays to the carrier plates.

④ Target PositionerOverlay

Shows the patient’s isocenter. Printed out and taped to the carrierplates.



5.1.2 Attaching the Overlays and Carrier Plates

Before you Begin

Due to their construction, the carrier plates can only be attached to the target positioner in oneposition.If required, remove the top aluminum panel of the Stereotactic Target Positioner to save weight.

How to Attach the Overlays and Carrier Plates

Steps

1. Print out the target positioner overlays using your Brainlab treatment planning system(see the corresponding user guide for details).

2. Cut the corners of the overlays diagonally and laterally along the marks provided.

3. Place overlay A onto carrier plate A, and adjust it until the marks on both componentsmatch.

4.Use adhesive tape ③ to secure the overlay to the carrier plate ① (Figure 44).Verify that all marks and frames have been correctly aligned before proceeding.

5. Attach carrier plate A to side A of the target positioner while ensuring that all marksand frames are correctly aligned.

6.

Continue attaching carrier plates B, C and D (with overlays B, C, and D, respectively)to the corresponding sides of the target positioner.NOTE:Brainlab provides an alternate plate C if the mask protrudes into the normalplate C (anterior carrier plate) near the nose. This alternate plate C features a cutout tomake room for the mask. If you use the alternate plate C, cut out a section from over-lay C to accommodate the mask and carrier plate cutout.

7. Verify again that all marks and frames are correctly aligned.

The surface of the carrier plates is not scratch proof.

Correct Alignment

Do not perform patient treatment if the imprinted frame and positioning marks on the targetpositioner overlays are not correctly aligned with the carrier plates.

Do not perform patient treatment if the carrier plates do not fit correctly to thecorresponding position on the target positioner or if the frames are not correctly aligned.

To prevent the carrier plates/overlays from shifting, do not touch them after they have beenattached.



5.1.3 Mounting the Stereotactic Target Positioner

How to Mount the Target Positioner

Figure 45

Steps

1. Mount the Stereotactic Headring or Stereotactic Mask System to the couchmountadapter using the two t-screws provided.

2. Bring the three ball feet of the target positioner in line with the corresponding holes inthe headring or mask system (Figure 45, left).

3. Insert the ball feet into the holes and secure the target positioner by firmly tighteningthe three locks (Figure 45, right).

Safe Handling

Do not use the Stereotactic Target Positionerif the three ball feet do not fit correctly intothe holes provided in the Stereotactic Headring or Stereotactic Mask System, or if the locksdo not firmly secure the target positioner into place.

Do not use the Stereotactic Target Positioner for patient treatment if it is in any way warpedor damaged, or if parts of the target positioner or carrier plates are loose.



5.1.4 Positioning the System for Treatment

Before you Begin

Position the patient so that the isocenter on the overlays is aligned with the Linac isocenter(projected by wall lasers).Sometimes the weight of the patient may cause the couch to tilt downwards. This can becompensated using the tilt adjustment screw on the couchmount (see Page 24). Use a spirit levelto bring the Stereotactic Headring or Stereotactic Mask System into an exact vertical position.

Before every treatment, the lasers must be verified using the Winston-Lutz Test.

Equipment Verification

During preparation, verify that all components are working together correctly by irradiating an x-ray film during a phantom treatment.

How to Position the Patient for Treatment

Steps

1. Move the treatment couch into the 0° position.

2. Use the A/P, lateral and vertical translations of the treatment couch for the first isocen-ter adjustment.

3. If available, use the couchmount for fine adjustment to the isocenter (see Page 23).

4. Check that the isocenter printed on the overlays is aligned on all four sides with theLinac isocenter, as projected by the wall lasers.

5. Refasten the locks of the couchmount (see Page 25). This prevents further adjustmentusing the rotary knobs and provides additional positioning stability.

6.Set the couch and the gantry to the first treatment position according to your treatmentplan. The isocenter printed within the gray lesion contour should now be correctlyaligned with the laser-projected isocenter.

7. Use the Linac light field to verify that the printed gray irradiation area matches the lightfield.

8. Remove the target positioner.

9.Initiate treatment with the first field.For further treatment fields, mount the target positioner again, and follow steps 5through 9 as described in this table.

The Stereotactic Target Positioner must be removed prior to the treatment.



5.1.5 Using the Stereotactic Counterweight

General Information

The Stereotactic Counterweightoffsets the weight deviation that occurs when the BrainlabStereotactic Target Positioneris removed from the treatment table. This further improves patientpositioning accuracy during stereotactic treatment.

Stereotactic Counterweight

Figure 46

Device Compatibility

Only the medical devices specified below may be used with the StereotacticCounterweight.

Required devices

• Stereotactic Target Positioner• Brainlab Stereotacic Headring / or Mask System• Couchmount Adapter Brainlab Headring• Couchmount Brainlab Imaging CouchTop/Varian Exact• Imaging Couch Top for Varian Exact• Varian Exact Couch or, alternatively:• Varian IGRT Table Top with Varian IGRT Head End Interface

Optional devices ExacTrac Robotics

How to Attach the Stereotactic Counterweight

The patient must remain on the treatment table during Stereotactic Counterweight attachment.Hold the Stereotactic Counterweight steady with both hands during attachment.

Steps

1. Position the patient using the Stereotactic Target Positioner.

2. Remove the Stereotactic Target Positioner from the Brainlab Stereotactic Headring /or Mask System.



Steps

3.

Align the Stereotactic Counterweightwith the couchmount adapter:

Figure 47

4. Feed the center bolt of the Stereotactic Counterweightinto the borehole of the couch-mount adapter (see Figure 47).

5.

Push the fixation screw inwards and turn it clockwise until the Stereotactic Counter-weightis securely mounted:

How to Detach the Counterweight

Once patient treatment has been completed, remove the Stereotactic Counterweight:

Steps

1. Hold the Stereotactic Counterweightwith one hand.

2. Turn the fixation screw counter-clockwise until the screw loosens.

3. Carefully remove the Stereotactic Counterweightand store in an appropriate location.

The Stereotactic Counterweight must be removed before attaching the Brainlab StereotacticTarget Positioner.

Service & Support

A CW_Alignment_Tool is provided for service use only. For further information, contact your localBrainlab representative.



5.2 Target Positioner for Leksell Headring5.2.1 Overview

Overview

The Target Positioner for Leksell Headring may only be used with the Leksell G-Frameheadring. It enables alignment of the patient’s isocenter with the wall lasers.

The Target Positioner for Leksell Headring may only be used with a Brainlab treatmentplanning system.

Components

①

② ④

③

Figure 48


① Target PositionerCarrier Plates One carrier plate is attached to each side of the target positioner.

② Stereotactic TargetPositioner Consists of an aluminum frame with room for four carrier plates.

③ Adhesive Tape Used to attach the overlays to the carrier plates.

④ Target PositionerOverlay

Shows the patient’s isocenter. Printed out and taped to the carrierplates.

Target Positioner for Leksell Headring


5.2.2 Attaching the Overlays and Carrier Plates

Before you Begin

Due to their construction, the carrier plates can only be attached to the Target Positioner forLeksell Headring in one unique position.If required, remove the top aluminum panel of the Target Positioner for Leksell Headringto saveweight.

How to Attach the Overlays and Carrier Plates

Steps

1. Print out the target positioner overlays using your Brainlab treatment planning system(see the corresponding user guide for details).

2. Cut the corners of the overlays diagonally and laterally along the marks provided.

3. Place overlay A onto carrier plate A and adjust it until the marks on both componentsmatch.

4.Use adhesive tape ③ to secure the overlay to the carrier plate ①.Verify that all marks and frames have been correctly aligned before proceeding.

5. Attach carrier plate A to side A of the Target Positioner for Leksell Headring whileensuring that all marks and frames are correctly aligned.

6.

Continue attaching carrier plates B, C and D (with overlays B, C, and D, respectively)to the corresponding sides of the Target Positioner for Leksell Headring.NOTE:Brainlab provides an alternate plate C if the mask protrudes into the normalplate C (anterior carrier plate) near the nose. This alternate plate C features a cutout tomake room for the mask. If you use the alternate plate C, cut out a section from over-lay C to accommodate the mask and carrier plate cutout.

7. Verify again that all marks and frames are correctly aligned.

The surface of the carrier plates is not scratch proof.

Correct Alignment

Do not perform patient treatment if the imprinted frame and positioning marks on the targetpositioner overlays are not correctly aligned with the carrier plates.

Do not perform patient treatment if the carrier plates do not fit correctly to thecorresponding position on the target positioner or if the frames are not correctly aligned.

To prevent the carrier plates/overlays from shifting, do not touch them after they have beenattached.



5.2.3 Mounting the Target Positioner for Leksell Headring

How to Mount the Target Positioner

Figure 49

Steps

1. Bring the four alignment pins of the Target Positioner for Leksell Headring in linewith the corresponding holes (Figure 49, left) of the Leksell G-Frame headring.

2. Insert the alignment pins into the holes. Aligning the two clamping units with the Lek-sell G-Frame headring (Figure 49, right), then securing the screws.

Safe Handling

To ensure secure and accurate positioning, objects should not be inserted between theLeksell G-Frame headring and Target Positioner for Leksell Headring.

Do not use the Target Positioner for Leksell Headring for patient treatment if it is in anyway warped or damaged, or if parts of the target positioner or carrier plates are loose.

Only use the Target Positioner for Leksell Headring if it can be firmly secured to the LeksellG-Frame Headring.



5.2.4 Positioning the System for Treatment

Before you Begin

Position the patient so that the isocenter on the overlays is aligned with the Linac isocenter(projected by wall lasers).Sometimes the weight of the patient may cause the couch to tilt downwards. This can becompensated using the tilt adjustment screw on the couchmount (see Page 24). Use a spirit levelto bring the Leksell G-Frame headring into an exact vertical position.

Equipment Verification

During preparation, verify that all components are working together correctly by irradiating an x-ray film during a phantom treatment.

Before every treatment, verify the lasers using the Winston-Lutz Test.

How to Position the Patient for Treatment

Steps

1. Move the treatment couch into the 0° position.

2. Use the A/P, lateral and vertical translations of the treatment couch for the first isocen-ter adjustment.

3. If available, use the couchmount for fine adjustment to the isocenter (see Page 23).

4. Check that the isocenter printed on the overlays is aligned on all four sides with theLinac isocenter as projected by the wall lasers.

5. Refasten the locks of the couchmount (see Page 25). This prevents further adjustmentusing the rotary knobs and provides additional positioning stability.

6.Set the couch and the gantry to the first treatment position according to your treatmentplan. The isocenter printed within the gray lesion contour should now be correctlyaligned with the laser-projected isocenter.

7. Use the Linac light field to verify that the printed gray irradiation area matches the lightfield.

8. Remove the Target Positioner for Leksell Headring.

9.Initiate treatment with the first field.For further treatment fields, mount the Target Positioner for Leksell Headring again,and follow steps 5 through 9 as described in this table.

The Target Positioner for Leksell Headring must be removed prior to treatment.



6 QUALITY ASSURANCE6.1 Winston-Lutz Test

Overview

The need for high geometric and dosimetric accuracy in stereotactic radiotherapy/radiosurgeryrequires a special quality assurance program.Brainlab recommends conducting a Winston-Lutz quality assurance test using the PhantomPointer.

The quality procedures described in this chapter must be performed prior to each patienttreatment.

The Winston-Lutz test needs to be performed prior to patient setup. If the Winston-Lutz testindicates a deviation greater than 1 mm, due to a mechanical misalignment of the Linac,this must be taken into consideration during the treatment planning.

QUALITY ASSURANCE


6.1.1 Testing with the Phantom Pointer for Brainlab Headring

Overview

Brainlab recommends using a 7.5 mm collimator, as the tungsten sphere in the Phantom Pointeris 5 mm in diameter.The sphere generates a non-irradiated area on the film. This projection of the tungsten spheremust always be completely inside the exposed film area for every gantry and table position.

Do not use theLightfield Pointer for the Winston-Lutz test. This pointer should only be usedfor calibrating the collimator mount.

Setup

③

④

Figure 50

How to Perform the Test

Steps

1. Affix the Phantom Pointer ④ to the couchmount adapter.

2. Use the couch translations to bring the Phantom Pointer close to the isocenter as de-fined by the room lasers.

3. Use the translations of the couchmount to move the Phantom Pointer into the isocen-ter position (fine adjustment).

4.Insert the film holder ③ into one of the two sockets on the collimator mount. Choosethe socket that provides the largest range of gantry and couch rotation while avoidingpossible mechanical collision.

5.Prepare a light-proof 8" x 4" strip of ready-pack film by marking off 8 areas, numbered1 to 8 on the envelope. This allows for film exposure in 8 gantry and couch angle com-binations.

Winston-Lutz Test


Steps

6. Position the film for each exposure in the film holder with the area to be irradiated inthe circular field.

7. Fasten the screw on the film holder to fix the film during each exposure in the clamp.

8. Expose the film (see Page 94).

QUALITY ASSURANCE


6.1.2 Testing with the Phantom Pointer for a non-Brainlab Headring

Setup

①

②

③④⑤

Figure 51

No. Component

① Film holder

② Phantom Pointer tip

③ Pointer rod

④ Ball pointer tip ø 2.9 mm diameter

⑤ Ball pointer tip ø 5 mm diameter

How to Perform the Test

Steps

1. Affix the Phantom Pointer tip securely to the pointer rod and fasten it into the hole inthe center of the front plate on the couchmount.

2. Use the couch translations to bring the Phantom Pointertip close to the isocenter asdefined by the room lasers.

3. Use the translations of the couchmount to move the Phantom Pointertip into the iso-center position (fine adjustment).

4.Insert the film holder ① into one of the two sockets on the collimator mount.Choose the socket that provides the largest range of gantry and couch rotation whileavoiding possible mechanical collision.

Winston-Lutz Test


Steps

5.

Remove the Phantom Pointer tip and securely replace it with the ball pointer tip. Thetungsten sphere at the tip simulates the isocenter and should align with the lasers.• Brainlab provides two different tungsten sphere tips of diameters 2.9 mm and 5 mm.

Brainlab recommends using a 7.5 mm collimator and the 5 mm ball pointer tip.• The sphere generates a non-irradiated area on the film. This projection of the tung-

sten sphere must always be completely inside the exposed film area for every gantryand table position.

6.Prepare a light-proof 8" x 4" strip of ready-pack film by marking off 8 areas, numbered1 to 8 on the envelope. This is for exposure of the film in 8 combinations of gantry andcouch angles (see Page 94).

7. Position the film for each exposure in the film holder with the area to be irradiated inthe circular field.

8. Fasten the screw on the film holder to fixate the film during each exposure.

QUALITY ASSURANCE


6.1.3 Film Exposure

Recommended Positions

The recommended gantry and couch angles at which the exposures should be made are shown inthe table below. All positions refer to the IEC 61217 scale.

Position Gantry Angle Couch Angle

1. 110° 0°

2. 30° 0°

3. 310° 0°

4. 230° 0°

5. 250° 270°

6. 330° 315°

7. 50° 45°

8. 110° 90°

Additional positions might be necessary in order to gain detailed information aboutmechanical inaccuracies of the specific Linac and couch.

Film Analysis

Figure 52 After the film has been developed, inspect the eight images to determine variations in the positionof the target ball relative to the center of the radiation beam. The pattern should approximate theabove figure.The data collected during the commissioning of the Brainlab radiosurgery system should form thebaseline to which future tests are compared.

Winston-Lutz Test


7 CLEANING,DISINFECTION, ANDSTERILIZATION

7.1 Reprocessing7.1.1 Automatic Cleaning and Disinfection

How to Clean and Disinfect

Steps

1. Transfer the instruments to the washer-disinfector. Use baskets for small instruments.

2. Start the program.

3. After the program has finished, let the instruments dry and then remove them.

Cleaning Detergent

Pay attention to the following points when selecting cleaning detergents:

Detergent

The detergent used for cleaning must be fundamentally approved for instru-ment cleaning.The instructions of the detergent manufacturers regarding concentration mustbe observed.

Efficiency

The efficiency of the detergent should be officially approved if a program isused that is not recommended by the Robert Koch Institute (part of the Ger-man Federal Ministry for Health or “BMG”).Examples of approved efficiency:• FDA clearance• CE marking• Products listed by DGHM (German Society for Hygiene and Microbiology)

and ÖGHMP (Austrian Society for Hygiene, Microbiology and PreventiveMedicine)

Compatibility Compatibility with the instruments to be cleaned.

CLEANING, DISINFECTION, AND STERILIZATION


Thermo Disinfector

Pay attention to the following points during thermo disinfection:

Disinfector

The disinfector should have regulatory clearance in the jurisdiction in which itis being used. For example:• FDA clearance• CE marking• Products listed by DGHM (German Society for Hygiene and Microbiology)

and ÖGHMP (Austrian Society for Hygiene, Microbiology and PreventiveMedicine)

ProgramOnly a cleaning and disinfection program that is recommended by the RobertKoch Institute may be used. This program must comprise at least 10 min. at93°C/195.4°F, with sufficient rinsing and drying steps and filtered air.

Water Only sterile or low contaminated (< 10 cfu/ml) distilled or deionized water canbe used for post-rinsing.

Maintenance &Calibration

Periodical maintenance and calibration of the washer-disinfectant must be per-formed.

Validation Parameters

The fundamental suitability of the instruments for effective automatic cleaning and disinfection wasvalidated by an independent test laboratory using the following parameters:

Thermo disinfector machine Type: MCU G7736CD

Manufacturer Miele

Cleaning detergent Type: neodisher® MediZym (pH neutral cleaning solution)

Manufacturer Dr. Weigert

Concentration In accordance with manufacturer’s specifications

Other Procedures

If procedures other than those described above are used (for example: chemo disinfectant), thefundamental suitability and efficiency must be validated.

Reprocessing


7.1.2 Neutral Steam Sterilization

Applicable Technology

Only use the following sterilization procedure, which has been validated in accordance with ISO17665 and AAMI TIR 12-2004:• Prevac/fractionated vacuum procedure with at least three vacuum phases

The use of other sterilization procedures may require longer sterilization times and must bevalidated. This is the responsibility of the user.

Fractionated Vacuum Procedures

Minimum Sterilization Time Minimum Sterilization Tempera-ture

Procedure 1 20 min. 121°C (max. 124°C) (270°F, max255°F)

Procedure 2 at least 4 min. 132°C - 135°C (270°F - 275°F)

Procedure 3 (UK Only) at least 3 min. 134 - 137°C (273 - 279°F)


The fundamental suitability of the instruments for an effective steam sterilization was validated byan independent test laboratory using the following parameters:

Sterilizer Euro-Selectomat 666, Münchner Medizin Mechanik, Planegg

Program Fractionated vacuum procedure

Sterilization Temp. 121°C

Sterilization Time 20 minutes



7.1.3 Low Temperature Plasma Sterilization (LTP)

Abbreviation

Throughout this guide, the term low temperature plasma sterilization will be abbreviated as LTPSterilization.

Applicable Technology

• Only LTP sterilization and sterilizers that conform to the requirements of ISO 14937 should beused

• The selected sterilization procedure must be validated in accordance with ISO 14937• Observe the underlying restrictions pertaining to the LTP sterilization procedure in your country

LTP Sterilization Parameters

Low Temperature Plasma Sterilization (LTP) using a STERRAD® 100S

Sterilization ParameterLong Cycle FullShort Cycle


The fundamental suitability of the instruments for an effective Low Temperature PlasmaSterilization was validated by an independent test laboratory using the following parameters:


Sterilizer STERRAD® 100S

Manufacturer Johnson & Johnson

Program Short Cycle

If procedures other than those described above are used, the fundamental efficiency must beproven by validation.

Reprocessing


7.2 Stereotactic Hardware7.2.1 Overview

General Information

This information applies to all RT/RS Stereotactic Hardware. Instructions for specific hardware isprovided in subsequent sections.

Handling and Storage

Store RT/RS Stereotactic Hardware in a clean and dry area, safe from infectious products,impacts, scratches, and falling objects.

Maintenance

RT/RS Stereotactic Hardware does not require particular maintenance. Maintain its cleanliness byusing a smooth duster and the cleaning products used in the radiotherapy department.

Cleaning and Disinfection

The following are required:• A clean and smooth duster• A pair of gloves• A diluted disinfectant detergent, according to the rules in the radiotherapy department (or

according to the rules of the manufacturer)The cleaning and disinfectant products must comply with the following:• They must not be too acidic or too basic (pH-value between 6 and 8)• They must not contain caustic or corrosive substances• Their composition must not change the plastic structure• They must not be too abrasive

Never use abrasive products (scourers or pad scourers) or solvents.



7.2.2 Stereotactic Headring

Handling and Storage

Store the headring at the same place as the other stereotactic equipment. Often, a transportableinstrument cart is suitable for such purposes. Store the sterilized fixation pins in the sterilizationtray.

The Stereotactic Headring components are precise mechanical parts. Even minor damageto any of these parts may render the entire apparatus inoperable. Do not use the equipmentif it is any way warped, scratched, damaged, or any of the parts are loose. The equipmentmust be checked and tested for proper functionality prior to each treatment.

Headring: Cleaning and Disinfection

• Clean the headring periodically using a soft and dry cloth• The headring should additionally be cleaned with an enzymatic cleaning agent (e.g., from Dr.

Weigert), followed by rinsing in doubly distilled and, preferably, sterile water following anyprocedure or contact with biological substances

• You may only use an enzymatic cleaning detergent to clean the headring. You may not use analkaline cleaning detergent or an ultrasonic cleaner to clean the headring

• Stains may be removed using a slightly moistened cloth• Do not use sharp objects or rough materials to remove residue, especially near threaded

surfaces• Once cleaned, the headring should be thoroughly air-dried or dried using lint-free materials

Posts and Fixation Pins: Cleaning and Disinfection

Automatic cleaning and disinfection can be used for the posts and the fixation pins. See page 95

Headring Post Sterilization

The headring posts can be sterilized using:• Neutral Steam Sterilization (Page 97)• Low Temperature Plasma Sterilization (Page 98)

If steam sterilization is used regularly, the threads in the headring posts can be damaged.Check the posts regularly to ensure that the threads in particular are in good condition.Replace the posts immediately if chipping or perpendicular fibers are visible, if the CFRPmaterial is damaged, or if the headpins are difficult to screw in.

The sterilization process causes gradual deterioration of the material. Up to 100 re-processing cycles are possible using one of the specified sterilization methods listedabove.

Fixation Pin Sterilization

The fixation pins must be sterilized after use. Clean, disinfect, and dry the fixation pins effectively,then transfer them to the sterilization tray prior to sterilization.Wrap the Sterilization Tray in suitable single-use sterilization packaging in accordance with EN868 and AAMI/ISO 11607 (e.g., paper/foil sterilization bags).Sterilize the fixation pins using:• Neutral Steam Sterilization (Page 97)• Low Temperature Plasma Sterilization (Page 98)

Stereotactic Hardware


The user is fully responsible for any deviations from the recommended cleaning,disinfection, and sterilization processes. If the processes are altered, the desired effectmay not be achieved. Brainlab excludes any liability in such cases.

Following sterilization, wait until instruments are cooled down to room temperature beforeuse. The use of hot instruments could injure the patient or damage non-heat resistantinstruments.

If applied properly, Brainlab fixation pins can be used for up to two years or sterilized up to150 times, whichever occurs first. Using the STERRAD® 100S sterilization system, up to100 re-processing cycles are possible. The pins may shatter if uneven or extreme torque isapplied, or if less than four fixation pins are used.



7.2.3 Stereotactic Mask System

Maintenance and Storage

Store the mask in a cool dry place, out of direct sunlight and away from open flames andother sources of heat.

Do not heat the hardened mask above 40°C (104°F).

Mask Ring: Cleaning

It is recommended that the mask ring be periodically cleaned using a soft and dry cloth.Stains may be removed using a slightly moistened cloth.The mask ring should additionally be cleaned with an enzymatic cleaning agent (e.g., from Dr.Weigert), followed by rinsing in doubly distilled and, preferably, sterile water following anyprocedure or contact with biological substances.Do not use sharp objects or rough materials to remove residue, especially near threadedsurfaces.Once cleaned, the mask ring should be thoroughly air-dried, or dried using lint-free materials.

You may only use an enzymatic cleaning agent to clean the mask ring. You may not use analkaline cleaning agent or an ultrasonic cleaner to clean the mask ring.

Mask Ring: Disinfection and Sterilization

No sterilization or disinfection is ordinarily required.

Mask Set

The Stereotactic Mask Set is delivered non-sterile and is for single patient use only.

Do not use warm water (temperature 30°C (86°F) or higher), cleaning solutions, solvents orultrasonic cleaners to clean the Brainlab Mask Set.

The device must not be sterilized under any circumstances. Sterilization will destroy thedevice.



7.2.4 Upper Jaw Support and Reference Plates

Silicone Disposables

The silicone disposables are manufactured in a cleanroom. They are intended for single patientuse only and must be disposed after every use. They cannot be disinfected or sterilized.Additional protection (e.g., disposable finger coats) can be used to cover the silicone disposableson the reference plate, making sterilization unnecessary.

Upper Jaw Support: Cleaning and Disinfection

The Upper Jaw Support can be cleaned with a damp and lint-free cloth. The device can also becleaned and disinfected using automatic cleaning and disinfection. See page 95

Upper Jaw Support: Sterilization

The Upper Jaw Support may be sterilized using neutral steam sterilization. See page 97

Reference Plates: Cleaning and Disinfection

The reference plates are delivered non-sterile and therefore should be cleaned, disinfected, andsterilized before the first use.The reference plates should be cleaned and disinfected using automatic cleaning and disinfection.See page 95

Reference Plates: Sterilization

The reference plates must be cleaned, disinfected, and dried effectively prior to sterilization.The reference plates must be transferred to the Sterilization Tray prior to sterilization. Wrap theSterilization Tray in suitable single-use sterilization packaging in accordance with EN 868 andAAMI/ISO 11607 (e.g., paper/foil sterilization bags).Sterilize the reference plates using neutral steam sterilization (Page 97).

The reference plates must be sterilized according to AAMI TIR 12.

If the reference plate is used for more then one patient without any additional protection,sterilization becomes necessary.


Following sterilization, wait until instruments are cooled down to room temperature beforeuse. The use of hot instruments could injure the patient or damage non-heat resistantinstruments.



7.2.5 CT/X-Ray Localizer, CT/X-Ray Localizer for Leksell Headring


Do not store or use the localizer in humid places, under conditions of constant humidity, orabove 60°C (140°F).


It is recommended that the localizer be periodically cleaned using a soft and dry cloth. Stubbornstains may be removed with a slightly moistened cloth.

Make sure that the surface of the localizer is not damaged, as it is not scratch proof.

Do not use cleaning solutions, solvents, or ultrasonic cleaners to clean the localizer.

Sterilization

The localizer must not be sterilized under any circumstances. Sterilization will destroy thelocalizer.




7.2.6 Stereotactic Target Positioner, Target Positioner for Leksell Headring


The target positioner carrier plates are not scratch proof and must be handled with care.

Do not store or use the target positioner carrier plates in humid places, under conditions ofconstant humidity, or above 80°C (176°F).


It is recommended that the target positioner is periodically cleaned using a soft and drycloth. Stubborn stains may be removed with a slightly moistened cloth.

Sterilization

The target positioner carrier plates must not be sterilized under any circumstances. Do notuse cleaning solutions, solvents or ultrasonic cleaners to clean the plates.



INDEXA

Angio Distortion Correction Module............................................75automatic cleaning and disinfection........................................... 95

BBrainlab Headring for Elekta...................................................... 32

CCE Label.......................................................................................8cleaning detergent......................................................................95collimator mount......................................................................... 33

attaching................................................................................. 34detaching................................................................................ 35

compatible medical devicesBrainlab.................................................................................. 13non-Brainlab........................................................................... 16

conical collimator........................................................................41couchmount

common features....................................................................24Siemens ZXT..........................................................................26Siemens ZXT carbon fiber......................................................27types....................................................................................... 23Varian Exact........................................................................... 28

couchmount adapterBrainlab Headring...................................................................32types....................................................................................... 31

couchmount lite.......................................................................... 30CT/X-Ray Localizer

attachment..............................................................................73sterilization............................................................................104

CT/X-Ray Localizer for Leksell Headringattachment..............................................................................73sterilization............................................................................104

Ddetergent.................................................................................... 95disposal instructions..................................................................... 8documentation

user instructions..................................................................... 21

EElekta/Philips RAM.....................................................................26

Hhardware

careful handling...................................................................... 12

Iintended use...............................................................................12

Llanguage information....................................................................9low temperature plasma sterilization.......................................... 98

Nneutral steam sterilization...........................................................97

Rreference plates

sterilization............................................................................103

SSet for Low Mask Fixation.......................................................... 59Siemens TT-S.............................................................................28Stereotactic Headring

attaching posts....................................................................... 51attachment..............................................................................54components............................................................................ 48description.............................................................................. 47sterilization............................................................................100torque wrench.........................................................................52

Stereotactic Mask Systemcomponents............................................................................ 57description.............................................................................. 57molding dental support strip................................................... 62molding mask......................................................................... 60molding middle mask..............................................................61molding rear mask.................................................................. 60molding top mask................................................................... 63nose bridge.............................................................................62reattachment...........................................................................65sterilization............................................................................102Upper Jaw Support.................................................................67

Stereotactic Target Positioner.................................................... 77mounting.................................................................................80overlays and carrier plates..................................................... 79positioning.............................................................................. 81sterilization............................................................................105

support......................................................................................... 7Brainlab customer service...................................................... 20

sustainability.................................................................................8

TTarget Positioner for Leksell Headring....................................... 84

mounting.................................................................................86overlays and carrier plates..................................................... 85positioning.............................................................................. 87sterilization............................................................................105

thermo disinfector.......................................................................96trademarks

Brainlab.................................................................................... 8Non-Brainlab.............................................................................8

training........................................................................................20

UUpper Jaw Support

sterilization............................................................................103user guide

available guides......................................................................21legal information....................................................................... 8

INDEX


Vvalidation parameters................................................................. 96Varian ETR................................................................................. 26

Wwarranty........................................................................................8WEEE...........................................................................................8Winston-Lutz Test.......................................................................89

film exposure.......................................................................... 94Phantom Pointer for Brainlab Headring..................................90Phantom Pointer for non-Brainlab Headring...........................92

INDEX


brainlab.com

Art-No. 60912-97EN

*60912-97EN*

HARDWARE STEREOTACTIC RT / RS · Radionics (Integra Radionics, Inc.) Burlington, MA, USA...

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