BRAINLAB
CURVE DUAL NAVIGATION STATION System and Technical User Guide Rev 1.0
System and Technical User
196 Pages
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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
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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TABLE OF CONTENTS
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 4
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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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TABLE OF CONTENTS
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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System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
GENERAL INFORMATION
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
United States, Canada, Central Tel: +1 800 597 5911 and South America Fax: +1 708 409 1619
Brazil
Tel: (0800) 892 1217
UK
Tel: +44 1223 755 333
Spain
Tel: +34 900 649 115
France and French-speaking regions
Tel: +33 800 676 030
Africa, Asia, Australia, Europe
Tel: +49 89 991568 1044 Fax: +49 89 991568 811
Japan
Tel: +81 3 3769 6900 Fax: +81 3 3769 6901
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 [email protected] if you have improvement suggestions.
Manufacturer Brainlab AG Olof-Palme-Str. 9 81829 Munich Germany
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Legal Information
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 requirements 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 regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) 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
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System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
GENERAL INFORMATION
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.
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Symbols
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 various parts of an equipment or of a system to the same potential, not necessarily 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
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GENERAL INFORMATION
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.
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Symbols
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 D and 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
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GENERAL INFORMATION
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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Using the System
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.
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GENERAL INFORMATION
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, typically defined as large complex instruments
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Training and Documentation
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 specifications and compliances
System and Technical User Guide
Combines the contents of the System User Guide and the Technical 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.
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SYSTEM OVERVIEW
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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
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System Components
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 ③
① ④
⑧
⑤
⑦
⑥
Figure 1
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System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
SYSTEM OVERVIEW
No.
Component
①
Camera Cart
②
Camera
③
27” touchscreens
④
Monitor Cart
⑤
EM Field Generator Positioning Arm
⑥
EM Base Station
⑦
EM Field Generator fixation plate
⑧
EM 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
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System Setup
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
20
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 and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
SYSTEM OVERVIEW
Step • The Curve logo on the Monitor Cart points toward the patient • User and connection panels and the Camera Cart connector point away from the patient NOTE: Do not position the camera, monitors or any other part of the Curve system directly over the patient. 4.
Lock all brakes on the Monitor Cart and Camera Cart.
5.
Move monitors into desired position.
6.
Lock all locks on the monitor arms.
7.
Move camera into desired position.
8.
Connect all cables at the connection panel.
Warning Ensure that the system is set up so it is not possible for the patient to touch or come in contact with the equipment.
Related Links 2.2.3 OR Setups on page 23 3.2.3 Positioning Monitors on page 36 3.2.4 Locking Monitors on page 38 3.3 Panels and System Ventilation on page 39 4.3.4 Adjusting Camera Position on page 68 7.1 Locking and Unlocking Brakes on page 105 7.2 Docking Camera and Monitor Carts on page 108 7.3.2 Proper Transport Procedure on page 119
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