Brainlab ROBOTICS VERO Installation manual

ROBOTICS
VERO
Version 2.1
Hardware User Guide
Revision 1.1
Copyright 2015, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
GENERAL INFORMATION...................................................................................................5
Contact Data and Legal Information......................................................................................................5
Legal Information.........................................................................................................................................6
Symbols .......................................................................................................................................................7
Intended Use...............................................................................................................................................8
About this Guide ..........................................................................................................................................9
Compatibility with Medical Devices.....................................................................................................10
Brainlab Medical Software..........................................................................................................................11
Non-Brainlab Medical Devices ...................................................................................................................12
Training and Documentation.................................................................................................................13
Documentation...........................................................................................................................................14
ROBOTICS VERO......................................................................................................................15
Robotics Hardware and Software Components................................................................................15
Robotics Vero Software..............................................................................................................................17
Robotics Vero Hardware ............................................................................................................................18
Robotics with Imaging Couch Top..............................................................................................................20
Robotics with iBeam evo Couch Top..........................................................................................................21
Manual Controls.......................................................................................................................................22
Operating Robotics Vero........................................................................................................................25
Couch Set-up Verification When Not Using Robotics Vero.........................................................................26
Maneuvering Robotics Vero During Non-Patient Operation........................................................................27
Message Boxes And System Warnings......................................................................................................33
Using the Anti-Skid Mat..............................................................................................................................35
Cleaning.....................................................................................................................................................37
Maintaining the System..........................................................................................................................38
Service Brake Release...............................................................................................................................39
Auxiliary Power Supply For Brake Release................................................................................................42
Using The Service Locks ...........................................................................................................................43
Retrieving Version Information ...................................................................................................................44
ROBOTICS VERO SAFETY TECHNICAL INSPECTION........................45
STI - Safety Technical Inspection Requirements..............................................................................45
Damaged Equipment...............................................................................................................................46
Returning Damaged Equipment.................................................................................................................47
TABLE OF CONTENTS
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 3

REGULATORY INFORMATION......................................................................................49
Regulatory Information...........................................................................................................................49
EMC Notes.................................................................................................................................................50
APPENDIX.........................................................................................................................................53
Third-Party Licensing Information.......................................................................................................53
INDEX....................................................................................................................................................55
TABLE OF CONTENTS
4 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

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 Email
Worldwide Tel: [phone] [email protected]
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
Kapellenstr. 12
85622 Feldkirchen
Germany
GENERAL INFORMATION
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 5

1.1.1 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 Vero®is a registered trademark of Brainlab AG. in Germany and/or the US.
•iPlan®is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
•Meliseptol®is a registered trademark of B. Braun.
CE Label
• The CE label shows that the Brainlab product complies with the essential re-
quirements of Council Directive 93/42/EEC (the "MDD").
• According to the principles set out in the MDD, Robotics Vero is a Class IIb
product
Disposal Instructions
Only dispose of electrical and electronic equipment in accordance with statutory regulations. For
information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit:
http://www.brainlab.com/weee
Language Information
All Brainlab user guides are originally drafted in English.
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
Contact Data and Legal Information
6 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

1.2 Symbols
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
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 7

1.3 Intended Use
Indications for Use
Robotics Vero is a device used to compensate rotational patient misalignment (roll and pitch) in a
linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures.
Careful Hardware Handling
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.
Symbols on Hardware Components
Symbol Explanation
Type B equipment according to IEC 60601-1
Attention! Consult accompanying documents
MR Unsafe
Class II medical equipment
Refer to instruction manual/booklet
IPX0 The product is classified IPX0 according to IEC 60529:
No protection against the ingress of liquids and solid matters.
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
Units
All units in this user guide are according to SI-standards.
Intended Use
8 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

1.3.1 About this Guide
Audience
This guide provides an introduction and reference for the effective and correct use of Brainlab’s
Robotics Vero. This guide is written for all members of the clinical team who use or handle the
Robotics Vero or parts of it. You should read this guide carefully and acquaint yourself sufficiently
with the system before use.
GENERAL INFORMATION
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 9

1.4 Compatibility with Medical Devices
Brainlab Medical Devices
Compatible Brainlab Medical Devices
Robotics Vero is compatible with:
Brainlab Accessories Comment
Imaging Couch Top for Treatment Table Carbon couch top treatment table
Short Imaging Couch Top for Treatment Ta-
ble Short carbon couch top treatment 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.
Only use devices and spare parts specified by Brainlab with Robotics Vero. 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.
Compatibility with Medical Devices
10 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

1.4.1 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 Vero is compatible with
Brainlab Medical Software
ExacTrac Vero 3.2
Contact Brainlab support for clarification regarding treatment table and controller software
compatibility with Robotics Vero.
Other Brainlab Software
If you are running software versions other than those specified above, 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.
GENERAL INFORMATION
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 11

1.4.2 Non-Brainlab Medical Devices
Compatible Non-Brainlab Medical Devices
Medical Device Comment
Vero Couch Treatment table of Vero Linac (MHI-TM 2000) manufac-
tured by Mitsubishi Heavy Industries, Ltd.
iBeam evo 3rd party replacement Couch Top manufactured by Medical
Intelligence, Schwabmünchen, Germany)
iBeam evo Frameless Extension
iBeam evo Extension 415
Other Non-Brainlab Devices
Only combinations with non-Brainlab medical devices authorized by Brainlab may be used
together with Robotics Vero. Using medical device combinations that have not been
authorized by Brainlab may adversely affect the safety and/or the effectiveness of the
medical device.
Compatibility with Medical Devices
12 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

1.5 Training and Documentation
Brainlab Training
In order to ensure safe and appropriate use of the system, all users must participate in an
extensive training program before using the system for the first time. This training must be
delivered by:
• A representative of Mitsubishi Heavy Industries, Ltd. when held in Japan.
• A Brainlab representative when held in any country other than Japan.
ExacTrac Vero components and accessory devices may only be operated by medical
personnel trained in the use of this system by Brainlab, or, in Japan, Mitsubishi Heavy
Industries, Ltd.
Responsibility
This system solely provides assistance to the surgeon and does not substitute or replace
the physician’s experience and/or responsibility during its use.
GENERAL INFORMATION
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 13

1.5.1 Documentation
Intended Audience
Robotics Vero is intended to be:
• Operated, for normal use, under the authority of appropriately licensed or qualified persons by
operators having the required skills for a particular medical application, for particular specified
clinical purposes.
• Maintained in accordance with the recommendations given in this document.
• Subject to regular quality assurance performance and calibration checks by a qualified person.
• Used under environmental conditions and conditions of the electrical mains supply as specified
in this document.
Reading User Guides
The user guides describe complex medical devices and surgical navigation software that must be
used with care.
It is important that all users of system, devices and software:
• Read the user guides carefully before handling the equipment
• Have access to the user guides at all times
Available User Guides
User Guide Contents
Clinical User Guide, Exac-
Trac Vero • Detailed instructions on using the ExacTrac Vero patient posi- tioning system
Hardware User Guide, Imag-
ing Couch Top • Patient treatment using the Imaging Couch Top and exten- sions
Training and Documentation
14 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

2 ROBOTICS VERO
2.1 Robotics Hardware and Software Components
General Information
Robotics Vero is an electrical-motorized, remotely-controllable Patient Support System. It is
designed to be operated based on a medical PC/Laptop system.
It 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 ExacTrac Vero use-cases, medical workflows and clinical practice
please refer to the Clinical User Guide, ExacTrac Vero.
Robotics Vero can be operated locally as well as remotely from outside the treatment bunker
using the ExacTrac Vero patient positioning system.
Using Robotics Vero
Robotics Vero is intended to adjust rotational misalignments of the patient around the patient's
lateral and longitudinal axis.
Robotics Vero is intended to be operated within the working environment of a medical Electron
Accelerator, used to support automated patient positioning procedures in radiotherapeutic
application.
Robotics Vero is intended to be used for 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 to detect tumors.
Radiation therapy may be applied to any kind of patients body irrespective of patient age (head
and neck, lung, liver, prostate or spine patients), except patients with pacemaker. The patient's
weight shall not exceed 135 kg. To prevent injury to patients wearing pacemakers, the pacemaker
manufacturer should be contacted regarding possible hazards resulting from radiation exposure.
For detailed information please read the Clinical User Guide, ExacTrac Vero.
Operating Conditions
Environmental Ambient temperature: 10°C - 40°C (50°F - 104°F).
Air pressure: 860 - 1060 hPa
Humidity: 60 ± 15, non condensing
Electrical Supply (from
treatment couch) 48 Vdc nom. (41 Vdc -52 Vdc) at 2.5 A SELV
Auxiliary Power Supply 100 Vac - 240 Vac / 47 Hz - 63 Hz / 1.5 - 0.7 A
Protection class (Auxili-
ary Power Supply) II
ROBOTICS VERO
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 15

Expected Service Life
The expected service life of Robotics Vero is 10 years.
Coordinates and Angles
All statements about coordinates and angels in this User Guide are in accordance with IEC 61217
- 'Table Top System', designation Index: 't'.
Safety Notes
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 breast board
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.
Installation, service and maintenance shall only be performed by Brainlab service staff
and/or authorized service partners.
Emergency OFF
The device is integrated into the Emergency-Off (EMO) system of the Vero linac via the patient
positioning system ExacTrac Vero.
On activation of the Emergency-Off (EMO) of the Vero, Robotics Vero shuts down its movement
immediately.
The Emergency-Off system is not part of Robotics Vero but must be provided by the facility
operator.
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 Vero movement.
Robotics Hardware and Software Components
16 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

2.1.1 Robotics Vero Software
Software Overview
The Robotics Service Application and Robotics driver software provides you an alternative control
terminal for Robotics Vero 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 Vero in non patient operation;
System Information
License Quantity 1 Workspace
Operating System Support Windows
Contents Robotics Service Application; Robotics Driver
Language Support English
Brand Name Brainlab
ROBOTICS VERO
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 17

2.1.2 Robotics Vero 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)
• 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).
Figure 2
Robotics Hardware and Software Components
18 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1

Dimensions and Weights
Dimensions of the device w/o Imaging Couch Top in Home Position
Height 149 mm
Width 589 mm
Length 855 mm
Tare mass & patient mass
Device's mass 61 kg
Maximum patient load 135 kg
ROBOTICS VERO
Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1 19

2.1.3 Robotics with Imaging Couch Top
Safety Notes
The maximum distributed load permitted on Robotics Vero combined with the Imaging
Couch Top (with extension) is 135 kg.
The maximum point load at the cranial end of the Imaging Couch Top (no extension) is
92,5kg.
The maximum load on the Extension of the Imaging Couch Top is 40kg.
Do not step on the Imaging Couch top.
Warning Labels
The following warning labels are attached on Robotics Vero or its sub-components:
Label Explanation
• The maximum allowable point
load applied to the cranial end of
the Imaging Couch top (without
frameless extension) is 92.5kg.
• The maximum allowable load for
the Imaging Couch top frame-
less extension is 40 kg.
• Do not step on the Imaging
Couch top.
The patient's weight must not ex-
ceed 135 kg, evenly distributed
over the Imaging Couch top
The following warning label is attached to the Imaging Couch Top:
Label Explanation
The patient's weight must not ex-
ceed 135 kg, evenly distributed
over the Imaging Couch Top.
Robotics Hardware and Software Components
20 Hardware User Guide Rev. 1.1 Robotics Vero Ver. 2.1