Brainlab ExacTrac Technical manual

EXACTRAC
VARIAN
TRUEBEAM
LINACS
Version 6.x
Site Planning Manual
Revision 1.0
Copyright 2016, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
GENERAL INFORMATION...................................................................................................7
Contact Data and Legal Information......................................................................................................7
Contact Data................................................................................................................................................7
Legal Information .........................................................................................................................................8
Symbols .......................................................................................................................................................9
Symbols Used in This Guide ........................................................................................................................9
Hardware Symbols.....................................................................................................................................10
Intended Use.............................................................................................................................................11
Documentation.........................................................................................................................................12
SYSTEM OVERVIEW..............................................................................................................13
Introduction...............................................................................................................................................13
Technical Key Features ..........................................................................................................................14
SITE SPECIFICATIONS........................................................................................................15
Treatment Room.......................................................................................................................................15
Overview....................................................................................................................................................15
Treatment Room Overview ........................................................................................................................16
Cabling.......................................................................................................................................................18
Overview....................................................................................................................................................18
Cable Conduits ..........................................................................................................................................19
Cabling System..........................................................................................................................................23
Cable Specifications...................................................................................................................................24
Dual X-Ray Generator Cabinets HFE 601............................................................................................27
ExacTrac Computer Cabinet..................................................................................................................30
Heat Dissipation.......................................................................................................................................33
FLOOR BOXES............................................................................................................................35
12” Floor Boxes (Standard)...................................................................................................................35
Overview....................................................................................................................................................35
Recess Dimensions and Side Views for 12” Floor Boxes ...........................................................................37
Installation of 12“ X-Ray Floor Boxes .........................................................................................................39
Customized Cable Outlet ...........................................................................................................................42
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On Floor Boxes (Optional).....................................................................................................................43
Overview....................................................................................................................................................43
External Dimensions of the On Floor Boxes...............................................................................................44
Recommended Position of Above-Ground Floor Boxes .............................................................................45
CEILING AND WALL MOUNTS.....................................................................................47
Introduction...............................................................................................................................................47
Ceiling Mount Installation ......................................................................................................................50
How to Mount the Flat Panel Detector Systems .........................................................................................50
How to Mount the Ceiling Interface Plate ...................................................................................................52
Ceiling-Mounted Touch Screen Monitor (Optional)..........................................................................58
Overview....................................................................................................................................................58
Ceiling Frame Installation...........................................................................................................................63
Wall-Mounted Touch Screen Monitor (Standard)..............................................................................65
Ceiling Mounted In-Room Distribution Box.......................................................................................67
CONTROL ROOM......................................................................................................................69
Control Room Distribution Box ............................................................................................................69
Control Room Workspace......................................................................................................................71
ELECTRICAL REQUIREMENTS...................................................................................73
X-Ray Generator.......................................................................................................................................73
Computer Cabinet Power Supply.........................................................................................................75
System Mains Power & Protective Earth Cabling.............................................................................77
SYSTEM INTERLOCKS AND STATUS SIGNALS........................................81
Overview....................................................................................................................................................81
Emergency STOP Interlock....................................................................................................................82
General Information ...................................................................................................................................82
Varian Emergency STOP Interlock.............................................................................................................83
System Power Emergency OFF - ETX.................................................................................................84
Introduction ................................................................................................................................................84
Collision Detect Interlock and Motion Enable .............................................................................................85
ExacTrac Warning Lights .......................................................................................................................86
NETWORK REQUIREMENTS.........................................................................................89
Introduction...............................................................................................................................................89
TABLE OF CONTENTS
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EXACTRAC ROBOTICS.......................................................................................................91
Robotics Installation Requirements ....................................................................................................91
External Bluetooth Module ....................................................................................................................92
COMPLIANCES............................................................................................................................95
Statement of Compliance from Hospital/Contractor........................................................................95
Authorities.................................................................................................................................................96
APPENDIX.........................................................................................................................................97
Pre-Installation Kit...................................................................................................................................97
Standard Shipping List.........................................................................................................................106
Cable Classifications ............................................................................................................................107
Facility Pre-Installation Summary......................................................................................................109
Overview of Mains Power Supply and Interlocks......................................................................................109
Overview of Wire Diameters in Grounding and Functional Cables ...........................................................110
Generator Power Supply (Distribution Box).............................................................................................. 111
Types of Networks for Electricity Supply .........................................................................................114
IT Policy, Screen Saver.........................................................................................................................115
17” Floor Boxes for X-Ray Tubes.......................................................................................................116
PREINSTALLATION CHECKLISTS..........................................................................121
Floor Boxes.............................................................................................................................................121
Ceiling Brackets.....................................................................................................................................122
Electrical Infrastructure........................................................................................................................123
Conduits...................................................................................................................................................125
Logistics ..................................................................................................................................................126
INDEX..................................................................................................................................................127
TABLE OF CONTENTS
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TABLE OF CONTENTS
6 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

1 GENERAL INFORMATION
1.1 Contact Data and Legal Information
1.1.1 Contact Data
Support
If you cannot find information you need in this guide, or if you have questions or problems, contact
Brainlab support:
Region Telephone and Fax Email
United States, Canada, Central and
South America
Tel: [phone]
Fax: [phone] [email protected]
Brazil Tel: [phone] brazil.support@brain-
lab.com
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking regions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
Project Site Coordination
The Project Site Coordinator team for pre-installation can be contacted at:
•[email protected]
or
• [email protected] (for US customers only)
Feedback
Despite careful review, this manual may contain errors.
Please contact us at oncology[email protected] if you have suggestions as to how we can
improve this manual.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
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1.1.2 Legal Information
Copyright
This guide contains proprietary information protected by copyright. No part of this guide may be
reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks
•ExacTrac® is a registered trademark of Brainlab AG in Germany and/or the US.
•Brainlab® is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
•Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the United
States and other countries.
•Exact®, Truebeam®, TrueBeamSTx® and PerfectPitch® are registered trademarks of Varian
Medical Systems, Inc.
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, ExacTrac is a Class IIb prod-
uct.
NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
Disposal Instructions
The collimators contain lead and should only be disposed of in accordance with statutory
regulations.
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
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
Electronic Product Radiation Control (EPRC) Program (US Only)
According to the product classification for medical devices of the FDA Center for Devices and
Radiological Health, ExacTrac is defined as a medical charged-particle radiation therapy system
(product code IYE).
Based on 21 CFR (Code of Federal Regulations Title 21) of the CDRH, no performance standard
is applicable and General Radiological Health requirements apply (21 CFR 1000 - 1005).
Contact Data and Legal Information
8 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

1.2 Symbols
1.2.1 Symbols Used in This Guide
Warnings
Warnings are indicated by triangular warning symbols. They contain safety-critical
information regarding possible injury, death or other serious consequences associated
with equipment misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain safety-critical information
regarding 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.
GENERAL INFORMATION
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1.2.2 Hardware Symbols
Symbols on Hardware Components
Symbol Explanation
Type B Applied Part according to IEC 60601-1
Caution
Serial number
Article number
Date of manufacture
Manufacturer
Follow the instructions for use
Prescription only
Symbols
10 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

1.3 Intended Use
Indications for Use
ExacTrac is intended for placing patients at an accurately defined point within the treatment beam
of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Treatment
includes lesions, tumors and conditions anywhere in the body where radiation therapy is
indicated. ExacTrac is also used for monitoring the patient position during treatment.
Intended User
The intended users of ExacTrac are medical staff having received dedicated training for this
application, such as:
Title Education Actions
Radiation Therapist Education, training Main workflow
Radiation Oncologist/Physician Physician with MD Fusion approval, patient initialization
Medical Physicist/Physicist PhD in medical phys-
ics
System Quality Assurance, data
handling
(This classification depends on country-specific requirements/regulations and might vary from the
classifications above.)
Only trained medical staff may operate system components and accessory
instrumentation.
Known Contra-Indications
To prevent injury to patients wearing pacemakers, contact the pacemaker manufacturer
regarding possible hazards resulting from radiation exposure before commencing patient
treatment.
Place of Use
The application is to be used in the treatment room.
Careful Hardware Handling
System components and accessory instrumentation comprise precise mechanical parts.
Handle them carefully.
Only trained medical personnel may operate system components and accessory
instrumentation.
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
No modification of this equipment is allowed.
GENERAL INFORMATION
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1.4 Documentation
Intended Audience
This Site Planning Manual is intended as a reference for the effective and correct implementation
of ExacTrac in combination with a Varian TrueBeam Linear Accelerator. This guide is written for
customers (in particular, customers who have purchased or intend to purchase an ExacTrac
system), as well as all members of the clinical architectural, structural and consulting teams who
are involved in the planning and implementation of an ExacTrac system or parts of it.
This guide is to be provided to all relevant parties at the beginning of the planning process and
explained in appropriate detail. Read this user guide carefully and acquaint yourself sufficiently
with the system before planning its implemenation.
This Site Planning Manual contains important information about the responsibilities and duties of
all relevant parties as well as a detailed installation description. Pay special attention to the
warnings and cautions provided in this manual.
Reading User Guides
The user guides describe complex medical devices and software that must be used with care.
It is important that all users of system, instruments and software:
•Read the user guides carefully before handling the equipment
•Have access to the user guides at all times
Pre-Installation Information
It is highly recommended to read this document prior to the main system installation. The
customer is responsible for finishing all pre-working/pre-assembly steps to ensure a simple and
timely system installation. It is also very important that you inform Brainlab of all information
regarding the hospital’s electrical and spatial conditions.
At the end of the document is a checklist you can use to ensure that all listed requirements are
completed and finalized.
If a subcontractor shall perform the required pre-working/pre-assembly steps, the customer is
responsible for providing the subcontractor with this complete pre-installation information including
all warnings.
Please note that not all components and items described in this document belong to each
installed system. Please contact Brainlab support for details or if any constraints cannot be met.
Documentation
12 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

2 SYSTEM OVERVIEW
2.1 Introduction
Customer Responsibility
All structural preparations, such as reinforcement and/or strengthening for roof mounted items,
ceilings, superstructures, or any related objects are the responsibility of the customer.
SYSTEM OVERVIEW
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2.2 Technical Key Features
Infrared Components
The infrared components consist of the following:
• Ceiling-mounted infrared and video camera system.
•Wall-mounted touch screen monitor (standard).
• Control room workspace with monitor, keyboard and mouse.
• Compact-sized computer rack for computer, power supplies, electrical safety devices, control
electronics and excess cables (ExacTrac Computer Cabinet).
X-Ray Components
The X-ray components consist of the following:
• Two X-ray tubes recessed into the linac room floor.
• Two ceiling-mounted amorphous silicon detectors (ExacTrac Flat Panels).
•ExacTrac Console.
• Dual 65kW X-ray generator with integrated transformer unit.
Optional Components
Some optional components are:
• Ceiling-mounted Touch Screen Monitor for convenient handling (optional, standard is wall-
mount solution)
• Two X-ray Tubes mounted on-floor in the linac room (optional, standard is in-floor solution).
• Tilt alignments of targeting volume via ExacTrac Robotics.
Technical Key Features
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3 SITE SPECIFICATIONS
3.1 Treatment Room
3.1.1 Overview
General Information
The ExacTrac system shall only be installed in a bunker for medical radiotherapy accelerators
that has a stable foundation. Keep vibrations to a minimum since they influence the accuracy of
the tracking system.
Exposure to high neutron radiation can lead to recurring malfunction and permanent
damage to computer hardware and electronic components. For sites where patients will be
treated with energies 10 MV or higher, do not place the computer cabinet in the treatment
room as it is not designed for exposure to high neutron radiation.
The system must not be exposed to humid environment. Humidity can destroy the system
and can lead to short circuits.
The ExacTrac system is not designed for use in areas where there is a danger of explosion.
Moreover, the system must not be placed close to flammable materials, such as volatile
anesthetics, detergents or endogenous gases. Observe local regulations to avoid explosive gas
mixtures forming during usage and cleaning.
Ensure that the tracking volume of the ExacTrac infrared camera system is not reduced/modified
by other devices after the ExacTrac system has been accepted.
Do not install the ceiling mount and device mount in the direct airflow of an air conditioning or
heating system.
Do not install any of the electronic components described in this site planning manual
(e.g., monitors, cabinets, warning lights, distribution boxes) in the area of the linac’s
primary beam.
SITE SPECIFICATIONS
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3.1.2 Treatment Room Overview
Sample Set-Up
All major ExacTrac components and positions within the bunker have a dedicated numbered label
for further reference.
The following image shows an overview of the main system components in a treatment room
(diagram not meant to scale):
Floor Box with
X-Ray Tube
(left side)
2.1a
IR and Video
Camera System
1.1
Flat Panel
Detector
(right side)
X-Ray
Warning Light
Control-Room Workplace
X-Ray
Warning Light
Control Room
Distribution Box
Wall Mounted
Touch Screen
Monitor
(standard)
Ceiling Mounted
Touch Screen
Monitor
(optional)
Network Plug
(provided by
Hospital)
1.2
2.3a
2.5b
Treatment Couch
0.1
Primary Beam
Lasers
1.2
1.5
2.5a
Isocenter
2.4
ExacTrac Console
1.0
Computer Cabinet
Stand & Gantry
0.0
In-Room
Distribution Box
1.3
X-Ray
Dual Generator
2.0a 2.0b
4.0
2.2a
Floor Box with
X-Ray Tube
(right side)
2.1b 2.2b
Flat Panel
Detector
(left side)
2.3b
Control-Room
Workspace
1.6
Emergency Off
Emergency Off
Emergency Off
max. radius 2900
EXACT couchtop
with foot extension
3.2
External
Bluetooth Module
Power Plug
(for Robotics
Charger)
L
LL
15°
Figure 1
Treatment Room
16 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

Couch Clearance Specifications for Treatment Room (Measurements in mm)
Isocenter
radius 1855
couch end
EXACT couchtop
with foot extension
radius 2670
EXACT couchtop
w/o foot extension
radius 2460
necessary distance for
treating cranial cases
(Couchmount+Headring+
Localizer or Frameless)
15°
radius 2900
Figure 2
SITE SPECIFICATIONS
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3.2 Cabling
3.2.1 Overview
General Information
Position all components so that you can use the shortest cable whenever possible.
Determine the correct length of X-ray tube power cable necessary to connect the X-ray generator
to the X-ray tubes. Calculate an extra 3 m for the cabling within the X-ray generator to avoid too
much tension between the cables and the circuit points.
In most hospitals, conduits are required for ExacTrac cables due to hospital and local electrical
regulations and laws. Below is a table listing the requirements for these conduits.
NOTE: Brainlab does not require you to store ExacTrac cables within conduits. However, some of
the supplied cables are not plenum rated. Therefore, it may be necessary for some customers to
install all cables within conduits.
You are responsible for obtaining installation permits with respect to applicable local or
regional standards. This might affect cable routes, mains power and data cables
specifications, connection to potential equalization and where you install system
components.
Be aware that fire protection engineering aspects (plenum rating) may be affected when
installing cables and system components. Install cable conduits and cables so that they
are not a tripping hazard and the cables will not be damaged.
Cabling
18 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x

3.2.2 Cable Conduits
Sample Treatment Room Set-Up
The following image shows an overview of cable conduits (diagram not meant to scale):
3.2
In-Room
Distribution Box
Control-Room Workplace
External
Bluetooth Module
Stand & Gantry
0.0
Primary
Beam
1.3
Control Room
Distribution Box
1.5
Isocenter
2.4
ExacTrac Console
Control-Room
Workspace
1.6
Tube 1 Tube 2
2.2a 2.2b
1.0
Computer Cabinet
Hospital
Network
4.0
X-Ray
Dual Generator
2.0a 2.0b
2.3b
2.3a
1.2 1.2 1.1
2.5a
2.5b
Warning Light
Warning Light
Flatpanel
Flatpanel
IR Camera
L
LL
AØ75mm
D1 Ø75mm
G2 Ø50mm
J
TØ25mm
MØ130mm
OØ25mm
RØ50mm
IØ25mm
(optional)
CØ75mm
H2 Ø25mm
PØ25mm
B1 Ø75mm
G1 Ø50mm
(optional)
SØ75mm
= Ø25mm
= Ø50mm
= >Ø75mm
_
H1 Ø50mm
D2 Ø75mm
B2 Ø75mm
EØ50mm
KØ25mm
MØ130mm
UØ25mm
Grounding
Spot
Figure 3
SITE SPECIFICATIONS
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Treatment Room Sample Side View
The following image shows a side view of cable conduits (diagram not meant to scale):
3.2
2.0b
2.2a 2.2b
Network Plug
(provided by
Hospital)
1.2 2.3b
0.1
1.2
1.5
2.5a
2.4
1.0
0.0
1.3
Control-Room
Workplace
2.0a
2.5b
2.1b2.1a
2.3a
4.0
1.6
1.1
Treatment
Room
VMS Camera
ORB2H1 CT
G1
J
G2
M
A E
D2
S
= Ø25mm = Ø50mm = >Ø75mm
_
H2
optional
D1
B1
U
Figure 4
Cabling
20 Site Planning Manual Rev. 1.0 ExacTrac Ver. 6.x