Brainlab CURVE User manual

CURVE
DUAL
NAVIGATION
STATION
Version 1.2
System User Guide
Revision 1.0
Copyright 2017, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
GENERAL INFORMATION...................................................................................................7
Contact Data and Legal Information......................................................................................................7
Legal Information.........................................................................................................................................8
Symbols .....................................................................................................................................................10
Symbols Used in This Guide......................................................................................................................10
Hardware Symbols.....................................................................................................................................11
Intended Use.............................................................................................................................................14
Using the System.......................................................................................................................................14
Training and Documentation.................................................................................................................16
Training......................................................................................................................................................16
Documentation...........................................................................................................................................17
SYSTEM OVERVIEW..............................................................................................................19
System Components...............................................................................................................................19
System Setup............................................................................................................................................22
Curve Optical Tracking...............................................................................................................................22
Curve EM System Setup............................................................................................................................24
OR Setups.................................................................................................................................................25
Proper System Handling ........................................................................................................................27
Inspections................................................................................................................................................30
Annual Inspection ......................................................................................................................................31
Weekly and Monthly Inspections................................................................................................................32
Safety Inspection .......................................................................................................................................33
Malfunctions and Return Instructions.................................................................................................34
Malfunctions...............................................................................................................................................34
Return Instructions.....................................................................................................................................35
MONITOR CART..........................................................................................................................37
Components..............................................................................................................................................37
Cart Arms and Monitors .........................................................................................................................39
Range of Motion.........................................................................................................................................41
Positioning Monitors...................................................................................................................................44
Locking Monitors........................................................................................................................................46
Panels and System Ventilation .............................................................................................................47
Back Panels...............................................................................................................................................47
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Sound Panel ..............................................................................................................................................51
System Ventilation .....................................................................................................................................53
LED Indications..........................................................................................................................................54
Cabling.......................................................................................................................................................55
Cable Connection ......................................................................................................................................55
Cable Storage............................................................................................................................................58
CAMERA CART...........................................................................................................................59
Cart Components.....................................................................................................................................59
Camera Cart ..............................................................................................................................................59
Camera......................................................................................................................................................61
Cabling.......................................................................................................................................................62
Cable Attachment ......................................................................................................................................62
Camera Use...............................................................................................................................................64
Range of Motion.........................................................................................................................................66
Operating Position .....................................................................................................................................69
Adjusting Camera Position.........................................................................................................................70
LEDs and Acoustic Signals...................................................................................................................75
EM TRACKING UNIT...............................................................................................................77
EM Tracking Unit Components .............................................................................................................77
Overview....................................................................................................................................................77
EM Tracking Unit Setup..........................................................................................................................79
Overview....................................................................................................................................................79
Setting Up EM Tracking Unit......................................................................................................................80
Connecting EM Tracking Unit to Monitor Cart ............................................................................................84
Connecting EM Instruments.......................................................................................................................86
Using the EM Tracking Unit ...................................................................................................................87
Overview....................................................................................................................................................87
Positioning Components ............................................................................................................................88
Positioning Patient .....................................................................................................................................91
LEDs and Acoustic Signals...................................................................................................................93
Overview....................................................................................................................................................93
USING THE SYSTEM..............................................................................................................95
Powering System On...............................................................................................................................95
Turning On System ....................................................................................................................................96
System Shutdown....................................................................................................................................97
Sterile Use .................................................................................................................................................99
Sterile Camera Handle Drape....................................................................................................................99
Sterile Monitor Drape...............................................................................................................................101
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TRANSPORT................................................................................................................................105
Locking and Unlocking Brakes...........................................................................................................105
Monitor Cart Brakes.................................................................................................................................106
Camera Cart Brakes ................................................................................................................................107
Docking Camera and Monitor Carts...................................................................................................108
Before You Begin.....................................................................................................................................108
Transport and Parking Position................................................................................................................111
Docking and Undocking Procedure..........................................................................................................115
Transporting the System......................................................................................................................117
Proper Transport Procedure.....................................................................................................................119
Parking and Storage..............................................................................................................................121
Parking.....................................................................................................................................................121
Storage....................................................................................................................................................122
Transporting the EM Tracking Unit using Transport Cases.......................................................................123
Long Term Storage ..................................................................................................................................126
CLEANING......................................................................................................................................127
Cleaning Instructions............................................................................................................................127
Curve System ..........................................................................................................................................129
Protection Cover for Monitors...................................................................................................................131
Protection Cover for Camera....................................................................................................................132
Transport Cases.......................................................................................................................................133
INDEX..................................................................................................................................................135
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TABLE OF CONTENTS
6 System User Guide Rev. 1.0 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 regions 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 manual may contain errors.
Please contact us at [email protected] if you have suggestions as to how we can
improve this manual.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2 7

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.
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
Unitare 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:
www.brainlab.com/en/sustainability
To arrange the disposal of the UPS battery, please contact Brainlab support.
Registration, Evaluation and Authorization of Chemicals (REACH)
REACH is the European chemicals law that came into force to improve the protection of human
health and the environment from risks that can be posed by chemicals. The identification of a
substance as a substance of very high concern and its inclusion in the candidate list for REACH
creates certain legal obligations for the importers, producers and suppliers of an article that
contains such a substance. Brainlab requests suppliers to inform whether and to what extent
substances from the list are used in their products. For further information regarding REACH
processes at Brainlab, contact us here:
www.brainlab.com/en/sustainability
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
Federal Communications Commission (FCC) Statement
This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and used
in accordance with the instruction manual, may cause harmful interference to radio
Contact Data and Legal Information
8 System User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2

communications. Operation of this equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the interference at their expense.
Any changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate this equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
The WLAN module included in this product cannot be accessed by end users. The FCC ID of the
WLAN module is listed on the WLAN label attached to the Monitor Cart. Please contact Brainlab
Support in case of any related questions.
GENERAL 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.
Symbols
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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
AC current
Potential equalization point
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
Keep dry
Quantity of products in packaging
Batch code
Serial Number
Use by month YYYY
Date of manufacture
GENERAL INFORMATION
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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 to 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
Symbols
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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
Strong magnetic field
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:
• A 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.
Place of Use
The system is only for use indoors, in a hospital operating room.
Patient Population
The patient population consists of patients that could be treated via Brainlab application software
that are released for this Image Guided Surgery (IGS) device.
For details please refer to the relevant Software User Guide.
User Profile
The following describes the intended users of the system and their respective tasks:
• The clinical team (e.g. nurses) is responsible for transporting the Curve into the OR, setting up
and preparation of the system for sterile use prior to surgery with constant control of sterility
during surgery as well as shutting down, tidying and storage of the system after surgery.
• The clinical team (e.g. surgeons) is responsible for the configuration of the clinical setup and
the sterile use of Curve (interaction with Brainlab application Software and Hardware) during
image guided surgery.
• The cleaner is responsible for cleaning and storage of the device.
• The Brainlab medical technician is responsible for installation of the Brainlab device as well as
system maintenance, repair and support.
• The hospital medical technician is responsible for overseeing electrical safety of installed
devices and contacting Brainlab in case of additional support.
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.
Frequency of Use
The frequency of use is defined is defined according IEC 60601-1-6 to be between once per
month and several times per week.
Intended Use
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Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
System Maintenance
Do not carry out inspections or maintenance while Curve is being used for patient treatment.
Applied Parts
Depending on the clinical application software running on Curve, applied parts might be combined
with the platform on system level. For details please refer to the Brainlab documentation for that
part.
GENERAL INFORMATION
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1.4 Training and Documentation
1.4.1 Training
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.
Training and Documentation
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1.4.2 Documentation
Intended Audience
This user guide intended for surgeons and hospital staff.
Reading User Guides
User guides describe complex medical devices and surgical navigation software that must be
used with care.
It is important that all users of system, instruments and software:
• Read the user guides carefully before handling the equipment
• Have access to the user guides at all times
Disregarding information in the user guides, in particular the disregard of warning and cautions, is
considered to be abnormal use.
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 Details on cleaning, disinfecting and sterilizing instruments
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. 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 System Components
Terminology
The Curve Dual Navigation Station shall be referred to as “Curve system” 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 61)
• A medical computer unit for running software (see Technical User Guide)
• Touchscreen monitor units for displaying navigation and for user interaction with the software
(see page 39)
EM Tracking Unit
The EM Tracking unit consists of two main components, EM Base Station and EM Field
Generator. EM Base Station must be fixed to the OR table. EM Field Generator must be fixed to
either the Fixation Plate or the Positioning Arm when in use.
Optical Tracking
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 elements 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.
Basis for Electromagnetic Tracking
Electromagnetic (EM) tracking uses a 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.
SYSTEM OVERVIEW
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System Components
②
①
③
④
⑥
⑧
⑦
⑤
Figure 1
No. Component See
①Camera Cart Page 59
②Camera Page 61
System Components
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