Brainlab CURVE Manual

CURVE DUAL
DISPLAY
CURVE SINGLE
DISPLAY
Version 1.0
Technical User Guide
Revision 1.2
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
Intended Use.............................................................................................................................................10
Using the System.......................................................................................................................................10
Training and Documentation.................................................................................................................13
Training......................................................................................................................................................13
Documentation...........................................................................................................................................14
SYSTEM OVERVIEW..............................................................................................................17
Component Overview..............................................................................................................................17
System Components..................................................................................................................................17
Optical Tracking.........................................................................................................................................20
Monitor Cart ..............................................................................................................................................21
Overview....................................................................................................................................................21
3rd-Party Connections ...............................................................................................................................23
Camera Cart ..............................................................................................................................................25
Overview....................................................................................................................................................25
Camera Volume.........................................................................................................................................27
UPS..............................................................................................................................................................28
Overview....................................................................................................................................................28
UPS Signals...............................................................................................................................................29
UPS Battery...............................................................................................................................................30
TROUBLESHOOTING............................................................................................................31
Introduction...............................................................................................................................................31
Overview....................................................................................................................................................31
Troubleshooting: Monitor Cart..............................................................................................................32
Possible Occurrences................................................................................................................................32
Troubleshooting: Monitor.......................................................................................................................33
Touchscreen Display..................................................................................................................................33
Touchscreen ..............................................................................................................................................34
TABLE OF CONTENTS
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Failure Indication Screens..........................................................................................................................35
Troubleshooting: UPS.............................................................................................................................36
UPS Audio Signals.....................................................................................................................................36
UPS LED Indicator and System Status ......................................................................................................37
Troubleshooting: Camera Cart..............................................................................................................38
Possible Camera Occurrences...................................................................................................................38
ELECTRICAL SAFETY..........................................................................................................39
Introduction...............................................................................................................................................39
Monitor Cart...............................................................................................................................................39
Camera Cart - Curve Dual Display.............................................................................................................40
Recurrent Test Requirements ...............................................................................................................41
Overview....................................................................................................................................................41
Testing Overview........................................................................................................................................42
Safety Inspection Form - Recurrent Tests ..................................................................................................43
Performing Tests......................................................................................................................................45
Protective Earth Resistance/Functional Earth Resistance..........................................................................45
Equipment Leakage Current ......................................................................................................................46
Electrical Safety Test - Medical Electrical System............................................................................49
Overview....................................................................................................................................................49
Testing Medical Electrical Systems ............................................................................................................50
Safety Inspection Form - Medical Electrical Systems.................................................................................51
Touch Current for Medical Electrical Systems ............................................................................................53
COMPLIANCES AND SPECIFICATIONS.............................................................55
Electrical Standards................................................................................................................................55
Overview....................................................................................................................................................55
Environmental Requirements................................................................................................................56
Transport/Storage and Operating Conditions .............................................................................................56
System Specifications ............................................................................................................................57
Physical Characteristics.............................................................................................................................57
Technical Specifications.............................................................................................................................58
Compliances .............................................................................................................................................59
Electromagnetic Emissions........................................................................................................................59
General Electromagnetic Immunity ............................................................................................................60
Electromagnetic Immunity, Curve System..................................................................................................61
RF Communications Equipment.................................................................................................................63
Tested Cables............................................................................................................................................64
Hospital Network........................................................................................................................................65
Power Plugs..............................................................................................................................................66
Overview....................................................................................................................................................66
Regional Power Plugs................................................................................................................................67
USB Flash Drives.....................................................................................................................................68
TABLE OF CONTENTS
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Overview....................................................................................................................................................68
MAINTENANCE............................................................................................................................69
Inspections................................................................................................................................................69
Guidelines..................................................................................................................................................69
Annual Inspection by Brainlab....................................................................................................................70
Further Inspections ....................................................................................................................................71
Damaged Equipment...............................................................................................................................73
Procedure..................................................................................................................................................73
INDEX....................................................................................................................................................75
TABLE OF CONTENTS
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TABLE OF CONTENTS
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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]
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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1.1.2 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
Curve™ is a trademark application 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.
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, Curve 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:
brainlab.com/weee
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
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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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1.3 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 optical tracking system
• A computer unit that runs the software
• Display unit(s) 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
System components and accessory instrumentation comprise precise mechanical parts.
Handle them carefully.
Only trained medical personnel may operate system components and accessory
instrumentation.
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.
Symbols on Hardware Components
The following symbols may be found on the system:
Symbol Explanation
Potential equalization point
IP20 IP Classification
Do not reuse
Do not resterilize
Intended Use
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Symbol Explanation
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
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.
GENERAL INFORMATION
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Symbol Explanation
Markers on joints that identify the parking position.
Marker indicates correct transport position for the height of telescopic post
( Camera Cart - Curve Dual Display only).
Only move Camera Cart in transport position.
Only move Monitor Cart in transport position.
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.
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 the 3rd
edition 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.
NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted.
Intended Use
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1.4 Training and Documentation
1.4.1 Training
Brainlab Training
When using the navigation system for the first time, a Brainlab representative should be present
for guidance. Start with procedures of low complexity, where you can easily verify how a
navigation system will assist you and where the limitations are. Simulate procedures on cadavers
and/or phantoms before using the system with a patient.
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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1.4.2 Documentation
System Revision
The information in this guide is relevant for the system revisions below:
System Revision System Serial No. (Last Digits)
Curve Dual Display 1.0 SNABCDEFGHI - 19900
Curve Single Display 1.0 SNABCDEFGHI - 19905
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.
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
NOTE: Not all of the above-mentioned user guides are available or relevant for all Brainlab
products.
Training and Documentation
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Quick Reference Guides
Quick Reference Guides are available for most software applications and for some complex
instruments. They provide condensed information on using the software or hardware, and are
intended as a supplement to the user guides.
NOTE: Quick Reference Guides do not replace the user guides.
GENERAL INFORMATION
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Training and Documentation
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2 SYSTEM OVERVIEW
2.1 Component Overview
2.1.1 System Components
Terminology
Unless otherwise specified, both the Curve Dual Display and Curve Single Display shall be
referred to as “ Curve system” in this user guide.
Similarly, unless otherwise specified, the carts for both the Curve Dual Display and Curve Single
Display shall be referred to as “Monitor Cart ” and “Camera Cart” in this user guide.
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 58)
• Touchscreen monitor unit(s) for displaying navigation and for user interaction with the software
(see page 21)
SYSTEM OVERVIEW
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Components - Curve Single Display
①
②
③
④
⑤
Figure 1
No. Component
①Camera Cart - Curve Single Display
②Camera
③Monitor
④Touchscreen
⑤Monitor Cart - Curve Single Display, including medical computer unit
Component Overview
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Components - Curve Dual Display
①
④
③
②
⑤
Figure 2
No. Component
①Camera Cart - Curve Dual Display (with telescopic post and motorized controls)
②Camera
③Monitors
④Touchscreen
⑤Monitor Cart - Curve Dual Display, including medical computer unit
SYSTEM OVERVIEW
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2.1.2 Optical Tracking
General Information
Curve is a wireless, touchscreen-operated planning and navigation system designed for pre- and
intraoperative use.
Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light.
• Reflective elements, affixed to reference arrays on the patient and to instrumentation, reflect
the infrared signals back to the camera unit.
• Reflected signals from the reflective marker spheres and discs are captured and digitized by
each camera lens from a different angle.
• The software uses the camera input to calculate the relative three-dimensional positions of the
instruments and the patient reference arrays.
Component Overview
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