Brainlab CURVE User manual

CURVE
DUAL
NAVIGATION
STATION
Version 1.2
System and Technical User Guide
Revision 1.0
Copyright 2018, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................7
1.1 Contact Data........................................................................................................................................7
1.2 Legal Information ...............................................................................................................................8
1.3 Symbols..............................................................................................................................................10
1.4 Using the System .............................................................................................................................13
1.5 Training and Documentation..........................................................................................................15
2 SYSTEM OVERVIEW........................................................................................................17
2.1 System Components .......................................................................................................................17
2.2 System Setup ....................................................................................................................................20
2.2.1 Curve Optical Tracking......................................................................................................................20
2.2.2 Curve EM System Setup..................................................................................................................22
2.2.3 OR Setups .......................................................................................................................................23
2.3 Proper System Handling.................................................................................................................25
3 MONITOR CART...................................................................................................................29
3.1 Components......................................................................................................................................29
3.2 Cart Arms and Monitors..................................................................................................................31
3.2.1 Monitors............................................................................................................................................31
3.2.2 Range of Motion...............................................................................................................................33
3.2.3 Positioning Monitors.........................................................................................................................36
3.2.4 Locking Monitors..............................................................................................................................38
3.3 Panels and System Ventilation......................................................................................................39
3.3.1 Back Panels......................................................................................................................................39
3.3.2 LAN Connection...............................................................................................................................43
3.3.3 Sound Panel ....................................................................................................................................45
3.3.4 System Ventilation............................................................................................................................47
3.3.5 LED Indications................................................................................................................................48
3.4 Cabling................................................................................................................................................49
3.4.1 Cable Connection..............................................................................................................................49
3.4.2 Cable Storage..................................................................................................................................52
3.5 UPS......................................................................................................................................................53
3.5.1 Overview...........................................................................................................................................53
3.5.2 UPS Signals.....................................................................................................................................54
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3.5.3 UPS Battery .....................................................................................................................................55
4 CAMERA CART.....................................................................................................................57
4.1 Cart Components .............................................................................................................................57
4.1.1 Camera Cart .....................................................................................................................................57
4.1.2 Camera............................................................................................................................................59
4.2 Cabling................................................................................................................................................61
4.2.1 Cable Attachment..............................................................................................................................61
4.3 Camera Use........................................................................................................................................62
4.3.1 Overview...........................................................................................................................................62
4.3.2 Range of Motion...............................................................................................................................64
4.3.3 Operating Position............................................................................................................................67
4.3.4 Adjusting Camera Position...............................................................................................................68
4.4 LEDs and Acoustic Signals............................................................................................................74
5 EM TRACKING UNIT.........................................................................................................77
5.1 EM Tracking Unit Components......................................................................................................77
5.2 EM Tracking Unit Setup...................................................................................................................79
5.2.1 Overview...........................................................................................................................................79
5.2.2 Setting Up EM Tracking Unit ............................................................................................................80
5.2.3 Connecting EM Tracking Unit to Monitor Cart...................................................................................84
5.2.4 Connecting EM Instruments.............................................................................................................87
5.3 Using the EM Tracking Unit............................................................................................................88
5.3.1 Overview...........................................................................................................................................88
5.3.2 Positioning Components ..................................................................................................................89
5.3.3 Positioning Patient ...........................................................................................................................92
5.4 LEDs and Acoustic Signals............................................................................................................94
6 USING THE SYSTEM........................................................................................................97
6.1 Powering System On.......................................................................................................................97
6.2 System Shutdown ............................................................................................................................99
6.3 Sterile Use........................................................................................................................................100
6.3.1 Sterile Camera Handle Drape .........................................................................................................100
6.3.2 Sterile Monitor Drape .....................................................................................................................102
7 TRANSPORT..........................................................................................................................105
7.1 Locking and Unlocking Brakes...................................................................................................105
7.1.1 Monitor Cart Brakes .......................................................................................................................106
7.1.2 Camera Cart Brakes.......................................................................................................................107
7.2 Docking Camera and Monitor Carts...........................................................................................108
7.2.1 Before You Begin ............................................................................................................................108
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7.2.2 Transport and Parking Position ......................................................................................................110
7.2.3 Docking and Undocking Procedure................................................................................................115
7.3 Transporting the System ..............................................................................................................117
7.3.1 Requirements..................................................................................................................................117
7.3.2 Proper Transport Procedure...........................................................................................................119
7.4 Parking and Storage......................................................................................................................121
7.4.1 Parking............................................................................................................................................121
7.4.2 Storage ..........................................................................................................................................122
7.4.3 Transporting the EM Tracking Unit using Transport Cases.............................................................123
7.4.4 Long Term Storage.........................................................................................................................125
8 CLEANING................................................................................................................................127
8.1 Cleaning Instructions ....................................................................................................................127
8.1.1 Requirements..................................................................................................................................127
8.1.2 Cleaning the Curve System............................................................................................................129
8.1.3 Protection Cover for Monitors.........................................................................................................131
8.1.4 Protection Cover for Camera..........................................................................................................132
8.1.5 Transport Cases.............................................................................................................................133
9 TROUBLESHOOTING....................................................................................................135
9.1 Introduction .....................................................................................................................................135
9.2 Troubleshooting: Monitor Cart....................................................................................................136
9.3 Troubleshooting: Monitor.............................................................................................................137
9.3.1 Touchscreen Display.......................................................................................................................137
9.3.2 Touchscreen...................................................................................................................................138
9.3.3 Failure Indication Screens..............................................................................................................139
9.4 Troubleshooting: UPS ...................................................................................................................140
9.4.1 UPS Audio Signals..........................................................................................................................140
9.4.2 UPS LED Indicator and System Status ..........................................................................................141
9.5 Troubleshooting: Camera Cart....................................................................................................142
9.6 Troubleshooting: EM Tracking Unit............................................................................................143
10 ELECTRICAL SAFETY...............................................................................................145
10.1 Classification.................................................................................................................................145
10.2 Recurrent Test Requirements....................................................................................................146
10.2.1 Overview.......................................................................................................................................146
10.2.2 Test Steps ....................................................................................................................................147
10.2.3 Safety Inspection Form - Recurrent Tests.....................................................................................148
10.3 Performing Tests..........................................................................................................................150
10.3.1 Protective Earth Resistance..........................................................................................................150
10.3.2 Equipment Leakage Current.........................................................................................................151
10.3.3 Applied Part Leakage Current (Type BF) (for Optional EM Tracking Unit) ....................................154
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10.4 Electrical Safety Test - Medical Electrical System................................................................155
10.4.1 Testing Medical Electrical Systems...............................................................................................156
10.4.2 Safety Inspection Form - Medical Electrical Systems ...................................................................157
10.4.3 Touch Current for Medical Electrical Systems...............................................................................159
11 COMPLIANCES AND SPECIFICATIONS..................................................163
11.1 Electrical Standards.....................................................................................................................163
11.2 Environmental Requirements....................................................................................................164
11.3 System Specifications.................................................................................................................165
11.3.1 Physical Characteristics.................................................................................................................165
11.3.2 Technical Specifications................................................................................................................169
11.4 Compliances..................................................................................................................................171
11.4.1 Electromagnetic Emissions............................................................................................................171
11.4.2 General Electromagnetic Immunity...............................................................................................172
11.4.3 Electromagnetic Immunity, Curve System.....................................................................................173
11.4.4 RF Communications Equipment...................................................................................................176
11.4.5 Tested Cables...............................................................................................................................177
11.4.6 Supported Resolutions and Connectors .......................................................................................178
11.4.7 Hospital Network ..........................................................................................................................180
11.5 Power Plugs...................................................................................................................................181
11.6 USB Flash Drives..........................................................................................................................183
12 MAINTENANCE................................................................................................................185
12.1 Inspections....................................................................................................................................185
12.1.1 Overview.......................................................................................................................................185
12.1.2 Annual Inspection by Brainlab......................................................................................................186
12.1.3 Further Inspections.......................................................................................................................187
12.2 Malfunctions and Return Instructions.....................................................................................189
12.2.1 Malfunctions..................................................................................................................................189
12.2.2 Return Instructions.......................................................................................................................190
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1 GENERAL INFORMATION
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] [email protected]
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking
regions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
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 Unit. During these periods of time, spare parts
as well as field support are offered.
Feedback
Despite careful review, this user guide may contain errors. Please contact us at
user[email protected] if you have improvement suggestions.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
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1.2 Legal Information
Copyright
This guide contains proprietary information protected by copyright. No part of this guide may be
reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks
•Brainlab®is a registered trademark of Brainlab AG in Germany and/or the US.
•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: www.brainlab.com/patent.
CE Label
The CE label indicates 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:
www.brainlab.com/sustainability
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
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/sustainability
Legal Information
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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
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
System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2 9

1.3 Symbols
Warnings
Warning
Warnings are indicated by triangular warning symbols. They contain safety-critical
information regarding possible injury, death or other serious consequences associated
with device use or misuse.
Cautions
Cautions are indicated by circular caution symbols. They contain important information
regarding potential device malfunctions, device failure, damage to device or damage to
property.
Notes
NOTE: Notes are formatted in italic type and indicate additional useful hints.
Symbols on Hardware Components
The following symbols may be found on the system:
Symbol Explanation
Class 2 Wireless LAN
AC current
Equipotentiality
NOTE: To identify the terminals which, when connected together, bring the var-
ious parts of an equipment or of a system to the same potential, not necessari-
ly being the earth (ground) potential.
IPXY
Ingress Protection according to IEC 60529
X = Protection against ingress of solid objects
Y = Protection against ingress of liquid
Do not re-use
NOTE: Indicates a medical device that is intended for one use, or for use on a
single patient during a single procedure.
Do not resterilize
Symbols
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Symbol Explanation
Sterilized with ethylene oxide
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
Quantity of included items
Manufacturer's batch code
Manufacturer's serial number
Use by date
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Date of manufacture
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
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.
GENERAL INFORMATION
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Symbol Explanation
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
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
Symbols
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1.4 Using the System
Intended 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.
No components can be used in HF surgical equipment environment.
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.
Frequency of Use
The frequency of use is defined according IEC 60601-1-6 to be between once per month and
several times per week.
Technical Specifications
The technical specifications of Curve hardware components are subject to change due to
technical developments.
Careful Hardware Handling
Warning
Only trained medical personnel may operate system components and accessory
instrumentation.
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Plausibility Review
Warning
Before patient treatment, review the plausibility of all information input to and output from
the system.
Careful Handling of Hardware
System components and accessory instrumentation are comprised of precise mechanical
parts. Handle them carefully.
MR Environment
Warning
The Curve system has not been tested in an MR environment and is therefore classified as
MR unsafe.
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.
ME Systems
Warning
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.
NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted.
Using the System
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1.5 Training and Documentation
Brainlab Training
Before using the system, all users must participate in a mandatory training program held by a
Brainlab authorized representative to ensure safe and appropriate use.
Supervised Support
Before using the system for surgical procedures where computer-aided navigation is considered
critical, perform a sufficient number of complete procedures together with a Brainlab
representative.
Responsibility
Warning
This system solely provides assistance to the surgeon and does not substitute or replace
the surgeon's experience and/or responsibility during its use. It must always be possible
for the user to proceed without the assistance of the system.
Only trained medical personnel may operate system components and accessory instrumentation.
Extended OR Time
Brainlab Navigation Systems are sensitive technical equipment. Depending upon OR setup,
patient positioning, calculation durations and complexity, surgery duration using navigation may
vary. It is up to the user to decide whether a potential prolongation is acceptable for the respective
patient and treatment.
Reading User Guides
This guide describes complex medical software or medical devices that must be used with care.
It is therefore important that all users of the system, instrument or software:
• Read this guide carefully before handling the equipment
• Have access to this guide at all times
This User Guide
This user guide provides both a description of how to use the system and a technical reference.
Disregarding the information in this user guide (including warnings and cautions) is considered
abnormal use.
Available User Guides
NOTE: Available user guides vary depending upon the Brainlab product. If you have questions
regarding the user guides you received, please contact Brainlab support.
User Guide Contents
Software User Guides • Overview of treatment planning and image-guided navigation • Description of OR system setup
• Detailed software instructions
Hardware User Guides Detailed information on radiotherapy and surgical hardware, typi-
cally defined as large complex instruments
GENERAL INFORMATION
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User Guide Contents
Instrument User Guides Detailed instructions on instrument handling
Cleaning, Disinfection and
Sterilization Guide Details on cleaning, disinfecting and sterilizing instruments
System User Guide Detailed information on system setup
Technical User Guide Detailed technical information on the system, including specifica-
tions and compliances
System and Technical User
Guide Combines the contents of the System User Guide and the Techni- cal User Guide.
Instrument Assembly
If any instrumentation is used with this product, ensure that all instruments are correctly
assembled according to the instructions within the corresponding Instrument User Guide.
Training and Documentation
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2 SYSTEM OVERVIEW
2.1 System Components
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 user guide.
General Information
The Curve system is a navigation platform used for image guided surgery, consisting of:
• A camera unit
• A medical computer unit for running software
• Touchscreen monitor units for displaying navigation and for user interaction with the software
• A tracking system
• Optional EM Tracking Unit
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
SYSTEM OVERVIEW
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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.
The device itself does not offer an essential performance as defined by IEC 60601-1.
Nevertheless the influence of electromagnetic disturbances might lower performance
characteristics of the device such as:
• No or limited function of device
• Limited tracking volume
System Components
②
①
③
④
⑥
⑧
⑦
⑤
Figure 1
System Components
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No. Component
①Camera Cart
②Camera
③27” touchscreens
④Monitor Cart
⑤EM Field Generator Positioning Arm
⑥EM Base Station
⑦EM Field Generator fixation plate
⑧EM Field Generator
Related Links
3.2 Cart Arms and Monitors on page 31
4.1.2 Camera on page 59
5.1 EM Tracking Unit Components on page 77
SYSTEM OVERVIEW
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2.2 System Setup
2.2.1 Curve Optical Tracking
General Information
The Curve system is an optical-tracking, touchscreen-operated planning and navigation system
designed for pre- and intraoperative use.
•Monitor Cart and Camera Cart are delivered pre-installed and ready for use.
• All system components are suitable for continuous use during surgical procedures.
• Only use system components indoors, in an operating room.
Sterile Field
The Curve system is unsterile.
Warning
Do not allow the camera, monitors or any other part of the Curve system to enter the sterile
field.
Interferences
If camera’s infrared light interferes with other devices, reposition these devices and/or the camera
so that the interference is resolved.
The system produces electromagnetic fields that may interfere with other sensitive equipment,
and can itself be disturbed by other electromagnetic fields.
Electromagnetic Compatibility
Curve requires special precautions regarding electromagnetic compatibility (EMC) and must be
installed and put into service according to the EMC information provided in this guide.
Warning
For EMC reasons, do not use system components adjacent to or stacked on other
equipment. If it is unavoidable, verify that the Curve system operates normally.
MR Safety
Warning
The Curve system has not been tested in an MR environment.
How to Safely Position the System
Step
1. Remove protection covers from display and camera before entering the OR.
2. Move equipment into the OR.
3. Angle the system so that:
System Setup
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