Brainlab Robotics Installation manual

ROBOTICS
Version 2.1
Hardware User Guide
Revision 1.0
Date of issue: 2021-07-20 (ISO 8601)
Copyright 2021, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................5
1.1 Contact Data and Legal Information ..............................................................................................5
1.2 Legal Information ...............................................................................................................................6
1.3 Using the System ...............................................................................................................................7
1.4 Symbols................................................................................................................................................9
1.5 Compatibility with Medical Devices .............................................................................................11
1.5.1 Brainlab Medical Devices..................................................................................................................11
1.5.2 Brainlab Medical Software................................................................................................................12
1.5.3 Non-Brainlab Medical Devices .........................................................................................................13
1.6 Training...............................................................................................................................................14
1.7 Documentation..................................................................................................................................15
2 ROBOTICS.................................................................................................................................17
2.1 Robotics Hardware and Software Components ........................................................................17
2.1.1 Robotics Software............................................................................................................................19
2.1.2 Robotics Hardware...........................................................................................................................20
2.1.3 Robotics with Imaging Couch Top ....................................................................................................22
2.1.4 Robotics with iBeam evo Couch Top CA ..........................................................................................23
2.1.5 Robotics with kVue Pro Couch Top...................................................................................................24
2.2 Manual Controls................................................................................................................................25
2.2.1 Overview...........................................................................................................................................25
2.2.2 User Interface...................................................................................................................................27
2.2.3 Service Lock ....................................................................................................................................29
2.2.4 ON/OFF Switch................................................................................................................................30
2.2.5 Caudal End ......................................................................................................................................31
2.3 Remote Control Using the Radio Transmitter............................................................................32
2.4 Operating Robotics..........................................................................................................................33
2.4.1 Maneuvering Robotics During Patient Setup.....................................................................................33
2.4.2 Couch Set-up Verification When not Using Robotics........................................................................34
2.4.3 Maneuvering Robotics during Non-Patient Operation.......................................................................35
2.4.4 Message Boxes And System Warnings............................................................................................41
2.4.5 Using the Anti-Skid Mat....................................................................................................................44
2.4.6 Switching Robotics On/Off................................................................................................................46
2.4.7 Charging the Battery ........................................................................................................................47
2.5 Battery Charger.................................................................................................................................50
TABLE OF CONTENTS
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2.6 Cleaning..............................................................................................................................................51
2.7 Maintaining the System...................................................................................................................52
2.7.1 User Inspections ...............................................................................................................................52
2.7.2 Service Brake Release.....................................................................................................................53
2.7.3 Using the Service Locks...................................................................................................................55
2.7.4 Battery Maintenance ........................................................................................................................56
2.7.5 Retrieving Version Information .........................................................................................................62
3 ROBOTICS SAFETY TECHNICAL INSPECTION...................................63
3.1 STI - Safety Technical Inspection Requirements.......................................................................63
3.2 Damaged Equipment .......................................................................................................................64
3.2.1 Discontinuing Use .............................................................................................................................64
3.2.2 Returning Damaged Equipment .......................................................................................................65
3.3 Regulatory Information...................................................................................................................66
3.4 EMC Notes .........................................................................................................................................68
INDEX....................................................................................................................................................75
TABLE OF CONTENTS
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1 GENERAL INFORMATION
1.1 Contact Data and Legal Information
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] [email protected]
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]
Feedback
Despite careful review, this user guide may contain errors. Please contact us at
user[email protected] if you have improvement suggestions.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
Hardware User Guide Rev. 1.0 Robotics Ver. 2.1 5

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
•Brainlab®is a registered trademark of Brainlab AG in Germany and/or the US.
•ExacTrac®is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
•Bluetooth®is a registered trademark of Bluetooth SIG, Inc.
•Meliseptol®is a registered trademark of B. Braun.
•Exact™and TrueBeam™are trademarks of Varian Medical Systems, Inc.
•kVue™and kVue Pro™are trademarks of Qfix, USA.
Patent Information
This product may be covered by one or more patents or pending patent applications. For details,
see: www.brainlab.com/patent.
Language Information
All Brainlab user guides are originally drafted in English.
Disposal Instructions
When a medical device reaches the end of its functional life, clean the device of all biomaterial/
biohazards and safely dispose of the device in accordance with applicable laws and 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 or relevant substances that could be present in the medical equipment,
visit: www.brainlab.com/weee/
Report Incidents Related to This Product
You are required to report any serious incident that may have occurred related to this product to
Brainlab, and if within Europe, to your corresponding national competent authority for medical
devices.
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
Legal Information
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1.3 Using the System
Intended Use and Indications for Use/Intended Purpose
Robotics is intended to adjust rotational misalignments of the patient around the patient’s lateral
and longitudinal axis.
Robotics is intended to be operated within the working environment of a medical Electron
Accelerator, used to support automated patient positioning procedures in radiotherapeutic or
radiosurgery application.
Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear
accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
Intended User
The intended user group is trained medical personnel in hospitals, specifically radiographers
(MTRA’s) (applies for patient fixation and positioning) as well as physicists (applies for linac
isocenter quality assurance procedures).
Intended Patient Population
The patient population includes any medical condition in which the use of radiation therapy may
be appropriate such as cranial, head and neck or spine treatments of tumors. Radiation therapy
may be applied to any kind of patient body irrespective of patient age (i.e., head and neck, lung,
liver, prostate or spine patients), except patients who have a pacemaker. The patient's weight
shall not exceed 159 kg. To prevent injury to patients wearing pacemakers, contact the
pacemaker manufacturer regarding possible hazards resulting from radiation exposure. For
detailed information, see the corresponding clinical user guide.
Intended Use Environment
Ambient temperature 10°C - 35°C (50°F - 95°F)
Air pressure 860 - 1060 hPa
Humidity 60% ± 15% Non-condensing
Careful Hardware Handling
Warning
System components and accessory devices comprise precise mechanical parts that must
be handled with care. Even minor damage to any of these parts may render the entire
apparatus inoperable. Do not use system components if they are in any way warped,
scratched, damaged, or any of the parts are loose. The equipment must be checked and
tested for proper functionality prior to each treatment.
Warning
No modification of the equipment is allowed.
Plausibility Review
Warning
Before patient treatment, review the plausibility of all information input to and output from
the system.
GENERAL INFORMATION
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Units
All units in this user guide are according to SI standards.
Audience
This guide provides an introduction and reference for the effective and correct use of Robotics.
This guide is written for all members of the clinical team who use or handle the Robotics or parts
of it. You should read this guide carefully and acquaint yourself sufficiently with the system before
use.
Using the System
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1.4 Symbols
Warnings
Warning
Warnings are indicated by triangular warning symbols. They contain safety-critical
information regarding possible injury, death or other serious consequences associated
with device use or misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain important information
regarding potential 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 on Hardware Components
The below symbols may be found on the system.
Symbol Explanation
Type B Applied Part
NOTE: Applied parts that are normally not conductive and can be immediately re-
leased from the patient.
IPX0 The product is classified IPX0 according to IEC 60529:
No protection against the ingress of liquids and solid matters.
2.5ATH
Insert only a fuse* of type:
• SIBA 79200.2,5 / Imprinting: 2.5A - 250VAC T H
• Schurter SMD-SPT 2.5 / Imprinting: 2.5A - 250VAC T H
Spare part available with Brainlab Art./No.: RTM2 ELECTRICAL MOUNTING AC-
CESSORIES/49775
* Fuse: IEC 60127-2/5 with a nominal fuse rating of 2.5 Amperes [2.5A], time lag [T]
and high breaking capability [H]
Switch to bring the device into standby mode
GENERAL INFORMATION
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Symbol Explanation
Class II medical equipment
This medical electrical equipment contains an RF transmitter for operation
Refer to instruction manual/booklet
Do not step on device
Medical Device
Unique Device Identifier
Symbols
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1.5 Compatibility with Medical Devices
1.5.1 Brainlab Medical Devices
Compatible Brainlab Medical Devices
Robotics is compatible with:
Brainlab Accessories Comment
Imaging Couch Top for Varian Exact Imaging couch top for Varian Exact treatment
table
Imaging Couch Top for Varian Exact (Short) Short imaging couch top for Varian Exact treat-
ment table
Anti-Skid Mat Ensures comfortable patient positioning on the
treatment table
Other Brainlab Devices
Additional devices may become available after release of this manual. Contact Brainlab support if
you have any questions regarding device compatibility with Brainlab software.
Warning
Only use devices and spare parts specified by Brainlab with Robotics. Using unauthorized
devices/spare parts may adversely affect safety and/or effectiveness of the medical device
and endanger safety of patient, user and/or environment.
GENERAL INFORMATION
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1.5.2 Brainlab Medical Software
Authorization
Only authorized Brainlab employees may install software on the Brainlab system. Do not
install or remove any software applications.
Compatible Brainlab Medical Software
Robotics is compatible with:
Brainlab Medical Software
ExacTrac 6.0
Other Brainlab Software
If you are running software versions other than those specified above, please contact Brainlab
support for clarification regarding compatibility with Brainlab devices.
Only Brainlab medical software specified by Brainlab may be installed and used with the
system.
Brainlab Medical Software
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1.5.3 Non-Brainlab Medical Devices
Compatible Non-Brainlab Medical Devices - Robotics
Robotics is compatible with:
Medical Device Comment
Varian Exact Couch Treatment table manufactured by Varian Oncology
Systems, CA, USA
Varian TrueBeam Couch
RT-4551KVP All-in-One Couch Top Base
Frame (kVue Pro)
Third-party replacement couch top manufactured by
Qfix Systems, PA, USA
RT-4551KV1 kVue Standard Insert
RT-4551KV2 kVue Short Insert
RT-4551KV11 kVue Calypso Insert
RT-4551KV8 kVue Universal Tip Insert
RT-4544KV kVue Access 360 Prone
Breast Insert
RT-4551KV5 kVue DoseMax Insert
iBeam evo Couch Top CA Third-party replacement couch top manufactured by
Medical Intelligence, Schwabmünchen, Germany
iBeam evo Frameless Extension
iBeam evo Extension 415
Warning
To change from an Exact couch to a TrueBeam couch (or vice versa), Robotics must be
modified. This change may only be carried out by Brainlab support.
Other Non-Brainlab Devices
Only combinations with non-Brainlab medical devices authorized by Brainlab may be used
together with Robotics. Using medical device combinations that have not been authorized by
Brainlab may adversely affect the safety and/or the effectiveness of the medical device.
GENERAL INFORMATION
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1.6 Training
Brainlab Training
Before using the system, Brainlab recommends that all users should participate in a training
program held by a Brainlab representative to ensure safe and appropriate use.
Responsibility
This system solely provides assistance to the physician and does not substitute or replace the
physician's experience and/or responsibility during its use. It must always be possible for the user
to proceed without the assistance of the system.
Only trained medical personnel may operate system components and accessory instrumentation.
Training
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1.7 Documentation
Reading User Guides
This guide describes complex medical software or medical devices that must be used with care.
It is therefore important that all users of the system, instrument or software:
• Read this guide carefully before handling the equipment
• Have access to this guide at all times
Available User Guides
User Guide Contents
Clinical User Guide, ExacTrac • Patient treatment using the ExacTrac system
• Detailed software instructions
Hardware User Guide, Imaging Couch
Top • Patient treatment using the Imaging Couch Top and extensions
GENERAL INFORMATION
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Documentation
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2 ROBOTICS
2.1 Robotics Hardware and Software
Components
General Information
Robotics is an electrical-motorized, remotely-controllable Patient Support System. It is designed
to be operated based on a medical PC/Laptop system.
In clinical application Robotics is mounted between the treatment couch of a medical electron
accelerator and the couch top. In combination with the treatment couch of the medical electron
accelerator, it is possible to move the patient in all degrees of freedom.
For further details regarding use-cases, medical workflows and clinical practice refer to the
Clinical User Guide, ExacTrac.
As it can be controlled remotely by radio, Robotics can be operated locally as well as remotely
from outside the treatment bunker using the ExacTrac patient positioning system.
Using Robotics
Robotics is intended to adjust rotational misalignments of the patient around the patient's lateral
and longitudinal axis.
Robotics is intended to be operated within the working environment of a medical electron
accelerator, used to support automated patient positioning procedures in radiotherapeutic
applications. It is designed for use in a professional healthcare facility environment only.
Robotics is intended to be used as a medical appliance solely in combination with and under
control of a computer-aided patient positioning system.
Patient Population
The patient population includes any medical condition in which the use of radiation therapy may
be appropriate such as cranial, head and neck or spine treatments of tumors.
Radiation therapy may be applied to any kind of patient body irrespective of patient age (i.e., head
and neck, lung, liver, prostate or spine patients), except patients who have a pacemaker. The
patient's weight shall not exceed 159 kg. To prevent injury to patients wearing pacemakers,
contact the pacemaker manufacturer regarding possible hazards resulting from radiation
exposure. For detailed information, see the corresponding clinical user guide.
Operating Conditions
Environmental Ambient temperature: 10°C – 35°C (50°F – 95°F).
Air pressure: 860 - 1060 hPa
Humidity: 60% ± 15%, non condensing
Electrical Power Input: 100 Vac – 240 Vac / 47Hz – 63 Hz / 1.5 A – 0.7 A
Radio Control Bluetooth-based radio frequency band: 2.402 GHz to 2.480 GHz /
5 mW
ROBOTICS
Hardware User Guide Rev. 1.0 Robotics Ver. 2.1 17

Expected Service Life
The expected service life of Robotics is ten years.
Product Label
The product label displays the name of the device, Brainlab logo and serial number. It also
includes information about the disposal of electrical and electronic equipment.
Coordinates and Angles
All statements about coordinates and angles in this User Guide are in accordance with IEC 61217
- 'Table Top System', designation index: 't'.
Safety Notes
Warning
Robotics shall only be used together with ExacTrac in a linear accelerator environment.
Warning
Installation of the device changes the height of the treatment table, similar to standard
clinical set ups when immobilizing the patient by using a vacuum cushion, a breastboard
or an anti-skid mat or when applying other positioning devices. Therefore, it is not
recommended to set up patient treatment using solely the displayed value for the vertical
couch position, but verify the correct position using (e.g., the room lasers or X-ray
imaging). For certain tilt angles, it may be necessary to overwrite details of the vertical
treatment table position in your Record & Verify system. In such cases, the tolerance tables
must be adapted accordingly.
Warning
Installation, service and maintenance shall only be performed by Brainlab service staff
and/or authorized service partners.
Do not open the cover of Robotics. There are no user-serviceable parts inside the device.
To avoid injury or system damage due to clamping or shutting in between parts of the
device, the cover of the device must be mounted properly and show no damage. Do not
operate the device if the cover is damaged or has been removed.
Emergency OFF
The device is integrated into the emergency off (EMO) system of the medical electron accelerator
via the patient positioning system ExacTrac.
On activation of the emergency off (EMO) of the medical electron accelerator, Robotics shuts
down its movement immediately.
The emergency off system is not part of Robotics but must be provided by the facility operator.
Warning
The device is connected to the emergency off system of the linac. In case of emergency,
activate the emergency off switch(es) of the linac to stop Robotics movement.
Robotics Hardware and Software Components
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2.1.1 Robotics Software
Software Overview
The Robotics Service Application and Robotics driver software provides you an alternative
control terminal for Robotics during non-patient operation as well as enhanced diagnostic
features for the system.
Software Type Robotics service and maintenance application
Platform PC
Recommended System Requirements OS Windows XP; 500 MHz; RAM: 256 MB; USB 2.0
(1 port); Space on HD: 55 MB
License requirement Y
Features Steering of Robotics in non patient operation; Battery
monitoring; System Information
License Quantity 1 Workspace
Operating System Support Windows
Contents Robotics Service Application; Robotics Driver
Language Support English
Brand Name Brainlab
ROBOTICS
Hardware User Guide Rev. 1.0 Robotics Ver. 2.1 19

2.1.2 Robotics Hardware
Operating Range
Figure 1
Maximum Operating Ranges
Relative lateral tilt (Pitch/ψt): ± 2.7° max.
Speed lateral tilt: 0.43°/s average; 0.7 °/s max.
Relative longitudinal tilt (Roll/φt): ± 4° max.
Speed longitudinal tilt: 0.95°/s average; 2.25 °/s max.
Maximum speed vertical shift: 25 mm/s (Measured at the cranial end of Imaging
Couch Top for Varian Exact)
• Lateral tilt /Pitch is defined as rotation of the table top coordinate system (index t) around the Xt
axis.
• Longitudinal tilt /Roll is defined as rotation of the table top coordinate system (index t) around
the Yt axis. (Notifications in accordance with IEC 61217).
(ICT incl. ICT Frameless Extension):
Figure 2
Robotics Hardware
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