Brainlab CURVE Manual

CURVE
DUAL
NAVIGATION
STATION
Version 1.2
Technical User Guide
Revision 1.1
Copyright 2017, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
GENERAL INFORMATION...................................................................................................7
Contact Data and Legal Information......................................................................................................7
Legal Information.........................................................................................................................................8
Symbols .......................................................................................................................................................9
Symbols Used in This Guide........................................................................................................................9
Hardware Symbols.....................................................................................................................................10
Intended Use.............................................................................................................................................13
Using the System.......................................................................................................................................13
Training and Documentation.................................................................................................................15
Documentation...........................................................................................................................................16
SYSTEM OVERVIEW..............................................................................................................19
Component Overview..............................................................................................................................19
Optical Tracking.........................................................................................................................................21
Monitor Cart ..............................................................................................................................................22
3rd-Party Connections ...............................................................................................................................23
LAN Connection.........................................................................................................................................24
Camera Cart ..............................................................................................................................................25
Camera Volume.........................................................................................................................................27
UPS..............................................................................................................................................................28
UPS Signals...............................................................................................................................................29
UPS Battery...............................................................................................................................................30
EM Tracking Unit......................................................................................................................................31
TROUBLESHOOTING............................................................................................................35
Introduction...............................................................................................................................................35
Troubleshooting: Monitor Cart..............................................................................................................36
Troubleshooting: Monitor.......................................................................................................................37
Touchscreen Display..................................................................................................................................37
Touchscreen ..............................................................................................................................................38
Failure Indication Screens..........................................................................................................................39
Troubleshooting: UPS.............................................................................................................................40
UPS Audio Signals.....................................................................................................................................40
UPS LED Indicator and System Status ......................................................................................................41
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Troubleshooting: Camera Cart..............................................................................................................42
Troubleshooting: EM Tracking Unit .....................................................................................................43
ELECTRICAL SAFETY..........................................................................................................45
Introduction...............................................................................................................................................45
Curve Dual Navigation Station ...................................................................................................................45
Recurrent Test Requirements ...............................................................................................................46
Testing Overview........................................................................................................................................47
Safety Inspection Form - Recurrent Tests ..................................................................................................48
Performing Tests......................................................................................................................................50
Protective Earth Resistance.......................................................................................................................50
Equipment Leakage Current ......................................................................................................................51
Applied Part Leakage Current (Type BF) (for Optional EM Tracking Unit)..................................................55
Electrical Safety Test - Medical Electrical System............................................................................56
Testing Medical Electrical Systems ............................................................................................................57
Safety Inspection Form - Medical Electrical Systems.................................................................................58
Touch Current for Medical Electrical Systems ............................................................................................60
COMPLIANCES AND SPECIFICATIONS.............................................................63
Electrical Standards................................................................................................................................63
Environmental Requirements................................................................................................................64
Transport/Storage and Operating Conditions .............................................................................................64
System Specifications ............................................................................................................................65
Physical Characteristics.............................................................................................................................65
Technical Specifications.............................................................................................................................69
Compliances .............................................................................................................................................71
Electromagnetic Emissions........................................................................................................................71
General Electromagnetic Immunity ............................................................................................................72
Electromagnetic Immunity, Curve System..................................................................................................73
RF Communications Equipment.................................................................................................................75
Tested Cables............................................................................................................................................76
Hospital Network........................................................................................................................................77
Power Plugs..............................................................................................................................................78
Regional Power Plugs................................................................................................................................79
USB Flash Drives.....................................................................................................................................80
MAINTENANCE............................................................................................................................81
Inspections................................................................................................................................................81
Annual Inspection by Brainlab....................................................................................................................82
Further Inspections ....................................................................................................................................83
Damaged Equipment...............................................................................................................................85
TABLE OF CONTENTS
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INDEX....................................................................................................................................................87
TABLE OF CONTENTS
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TABLE OF CONTENTS
6 Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2

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]
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking re-
gions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
Expected Service Life
Brainlab provides eight years of service for Curve Dual Navigation Station. Brainlab provides a
minimum of five years of service for EM Tracking Device. During these periods of time, spare
parts as well as field support are offered.
Feedback
Despite careful review, this guide may contain errors.
Please contact us at [email protected] if you have suggestions as to how we can
improve this guide.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
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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
•Brainlab®is a registered trademark of Brainlab AG in Germany and/or the US.
•Curve ™ is a trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab Trademarks
•Intel®is a registered trademark of Intel Corporation in the US and other countries.
•Xeon®is a registered trademark of Intel Corporation in the US and other countries.
Patent Information
This product may be covered by one or more patents or pending patent applications. For details,
see: https://www.brainlab.com/patent/
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, Curve and the EM Tracking Unit
are Class IIb products.
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:
http://www.brainlab.com/en/sustainability
To arrange the disposal of the UPS battery, please contact Brainlab support.
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
8 Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2

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
The following symbols may be found on the system:
Symbol Explanation
Class 2 Wireless LAN
Potential equalization point
AC current
IPxy Ingress Protection according to IEC 60529 X = Protection against ingress of solid objects
Y = Protection against ingress of liquid
Do not reuse
Do not resterilize
Sterilized with ethylene oxide
Do not use if packaging is damaged
Keep away from sunlight/UV light
Keep dry
Quantity of products in packaging
Batch code
Serial Number
Use by month YYYY
Date of manufacture
Symbols
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Symbol Explanation
Manufacturer
Danger of clamping hand or other body parts in equipment
Do not look directly into the laser beam or point laser beam into the patient’s
face or eyes
Laser radiation emitted from aperture
Do not stare into beam
Class 2 laser product
max. output 1mW wavelength 635 nm
Radio device
Consult accompanying documentation
When the Dand line below it are lined up, the camera is perpendicular to the
base of the Camera Cart.
Markers on joints that identify the parking position.
Marker indicates correct transport position for the height of telescopic post.
Only move Camera Cart in transport position.
Only move Monitor Cart in transport position.
GENERAL INFORMATION
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Symbol Explanation
Visual hint: how to dock/undock system
Danger of tilting: Do not move system when brakes are locked or if device is
blocked by obstacles.
Symbols
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1.3 Intended Use
1.3.1 Using the System
System Use
The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating:
• An tracking system (optical or electromagnetic)
• A computer unit that runs the software
• Display units to display the navigation, including touch functionality for the user to interact with
the software.
Technical Specifications
The technical specifications of Curve hardware components are subject to change due to
technical developments.
Careful Hardware Handling
Only trained medical personnel may operate system components and accessory
instrumentation.
System components and accessory instrumentation comprise precise mechanical parts.
Handle them carefully.
Changes to the System
No modifications of the systems are allowed. Making changes to the specified product and
its intended use may result in severe harm to the patient, user or third-party.
MR Environment
The Curve system has not been tested in an MR environment.
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
ME Systems
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment and IEC
60601-1 for medical equipment). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of edition 3.1
of IEC 60601-1, respectively). Anyone connecting additional equipment to the Curve
System configures a medical system and is therefore responsible that the system complies
with the requirements for medical electrical systems. Please note that local laws take
priority over the above-mentioned requirements. In doubt, consult your local
representative or the technical service department.
GENERAL INFORMATION
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NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted.
Intended Use
14 Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2

1.4 Training and Documentation
Brainlab Training
To ensure safe and appropriate use, before using the system all users should participate in a
training program held by a Brainlab representative.
Supervised Support
Before using the system for surgical procedures where computer-aided navigation is considered
critical, perform a sufficient number of complete procedures with a Brainlab representative present
to provide guidance where necessary.
Responsibility
This system solely provides assistance to the surgeon and does not substitute or replace
the surgeon’s experience and/or responsibility during its use.
GENERAL INFORMATION
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1.4.1 Documentation
System Revision
The information in this guide is relevant for the system revisions below:
System Revision System Serial No. (Last Digits)
Curve Dual Navigation
Station 1.2 SNABCDEFGHI - 19901A
NOTE: The system serial number is shown on the type plate of the Monitor Cart.
Intended Audience
This user guide is intended for surgeons and hospital staff.
Abbreviations
“EM” is used to abbreviate electromagnetic in this user guide.
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 the system, instruments and software:
• Read the user guides carefully before handling the equipment
• Have access to the user guides at all times
Disregarding information in the user guides, in particular the disregard of warning and cautions, is
considered to be abnormal use.
How to Use this Guide
The information provided in this guide will help you to determine whether your navigation system
is functioning properly.
Use this guide, in combination with assistance from Brainlab support, to identify and troubleshoot
possible problems.
Do not attempt to service your system. Contact Brainlab support for questions regarding
repair and service.
Available User Guides
User Guide Contents
Software User Guides • Overview of treatment planning and image-guided navigation • Description of OR system setup
• Detailed software instructions
Instrument User Guides Detailed instructions on instrument handling
Cleaning, Disinfection and
Sterilization Guide Detailed instructions on cleaning, disinfecting and sterilizing in- struments
System User Guides Comprehensive information on system setup
Technical User Guide Detailed technical information on the system, including specifica-
tions and compliances
Training and Documentation
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NOTE: Not all of the above-mentioned user guides are available or relevant for all Brainlab
products. If you have questions regarding the user guides you received, contact Brainlab support.
GENERAL INFORMATION
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Training and Documentation
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2 SYSTEM OVERVIEW
2.1 Component Overview
Terminology
The Curve Dual Navigation Station is referred to as “Curve system” in this user guide. It
consists of the following parts:
•Curve Dual Monitor Cart
•Curve Dual Camera Cart
•EM Tracking Unit
Abbreviation
UPS is used to abbreviate “uninterruptible power supply” in this manual.
General Information
The Curve system is a navigation platform used for image guided surgery, consisting of:
• A camera unit (see page 26)
• A medical computer unit for running software (see page 69)
• Touchscreen monitor units for displaying navigation and for user interaction with the software
(see page 22)
• A tracking system
• Optional EM Tracking Unit
Electromagnetic Tracking
Electromagnetic (EM) tracking uses an EM Field Generator to create a known volume of a
varying magnetic field. This field induces voltage into coils located inside the EM instruments.
From the strength and phase of the induced voltages, the position of the instrument inside the
area of interest is calculated. Brainlab software applications use this tracking unit input to display
the three-dimensional position of the EM instruments relative to the EM Patient Reference.
Electromagnetic Compatibility
Special precautions regarding electromagnetic compatibility (EMC) must be installed and put into
service according to the EMC information provided in this guide and the System User Guide.
SYSTEM OVERVIEW
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System Components
②
①
③
⑤
④
Figure 1
No. Component
①Camera Cart with telescopic post and motorized controls
②Camera
③Monitors
④Touchscreen
⑤Monitor Cart, including medical computer unit
Component Overview
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