Technical User Guide
82 Pages
Preview
Page 1
KICK KICK EM Version 1.1
Technical User Guide Revision 1.3 Copyright 2016, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS GENERAL INFORMATION ...5 Contact Data and Legal Information ...5 Contact Data ...5 Legal Information ...7
Symbols ...8 Symbols Used in This Guide ...8 Hardware Symbols...9
Intended Use ...12 Training and Documentation ...13 Training ...13 Documentation...14
SYSTEM OVERVIEW ...17 System Components ...17 Monitor Cart ...20 Components ...20 3rd-Party Connections ...22 LAN Connection...24
Camera Cart ...25 Components ...25 Camera Volume ...28
EM Tracking Unit ...29
TROUBLESHOOTING ...35 Introduction ...35 Possible Occurrences with Monitor Cart ...36 Possible Occurrences with Camera Cart ...37 Troubleshooting: EM Tracking Unit ...38
ELECTRICAL SAFETY ...39 Classification ...39 Test Requirements ...40
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TABLE OF CONTENTS
General Information ...40 Testing Overview...41 Recurrent Tests...43
Performing Tests ...46 Protective Earth Resistance ...46 Leakage Current ...47 Insulation Resistance ...50
Reporting and Evaluating Results ...51
COMPLIANCES AND SPECIFICATIONS ...53 Electrical Standards ...53 Environmental Requirements...54 System Specifications ...56 Physical Characteristics ...56 Technical Specifications ...62
Compliances ...64 Electromagnetic Emissions ...64 General Electromagnetic Immunity ...65 Electromagnetic Immunity, Kick System...66 RF Communications Equipment...68 Tested Cables ...69 Hospital Network...70
Power Plugs ...71 USB Flash Drives ...72
MAINTENANCE ...73 Inspections ...73 General Information ...73 Weekly and Monthly Inspections ...74 Annual Inspection by Brainlab...75
Air Filter Exchange ...76 Damaged Equipment ...77
INDEX ...79
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Technical User Guide Rev. 1.3 Kick, Kick EM Ver. 1.1
GENERAL INFORMATION
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
United States, Canada, Central and South America
Tel: + 1 800 597 5911 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 44 Fax: +49 89 991568 811
Japan
Tel: +81 3 3769 6900 Fax: +81 3 3769 6901
Expected Service Life Brainlab provides a minimum of eight years of service for platforms and five years of service for the EM Tracking Unit. During this period of time, spare parts as well as field support are offered. The Kick and Kick EM system lifetime is dependent on factors such as method and duration of each use, and handling between uses. Careful functional testing and inspection of the Kick and Kick EM system before use is the best method for determining the end of lifetime. The end of lifetime is normally determined by wear and tear damage due to use. As part of preventive service, follow the maintenance instructions.
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 Kapellenstr. 12
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Contact Data and Legal Information
85622 Feldkirchen Germany
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Technical User Guide Rev. 1.3 Kick, Kick EM Ver. 1.1
GENERAL INFORMATION
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 Kick® 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.
CE Label • The CE label shows that the Brainlab product complies with the essential requirements of the Medical Device Directive (MDD). • According to the MDD, Council Device Directive 93/42/EEC, Kick and Kick EM are Class IIb products. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
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: http://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 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
1.2
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.
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GENERAL INFORMATION
1.2.2
Hardware Symbols
Symbols on Hardware Components The following symbols may be found on the system: Symbol
Explanation Type BF Applied Part according to IEC 60601-1
Caution
Potential equalization point
Do not reuse
Non-Sterile
Do not resterilize
Sterilized with ethylene oxide
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
Storage conditions for temperature: The specified temperature range is shown on each label.
Storage conditions for relative humidity non-condensing: The specified humidity range is shown on each label.
Storage conditions for air pressure: The specified air pressure range is shown on each label.
Radio device
Class 2 wireless LAN
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Symbols
Symbol
Explanation Quantity of products in packaging
Batch number
Serial Number
Article number
Use by month YYYY
Date of manufacture
Manufacturer
Authorized representative in the European Community
IPXY
Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects • Y = Protection against ingress of liquid Strong magnetic field
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 Danger of tilting: Do not move system when brakes are locked or if device is blocked by obstacles
Standby icon
Consult the operating instructions
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GENERAL INFORMATION
Symbol
Explanation
Consult accompanying documentation
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Intended Use
1.3
Intended Use
Intended System Use The Kick 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 • A display unit to display the navigation, including touch functionality for the user to interact with the software.
Technical Specifications The technical specifications of Kick hardware components are subject to change due to technical developments.
Careful Hardware Handling Only trained medical personnel may operate system components and accessory instrumentation. System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully.
Changes to the System Only use the system components as delivered by Brainlab. Do not modify the system in any way. Altering the system or using it outside of its intended use may result in severe harm to the patient, user or third-party.
MR Environment The Kick system has not been tested in an MR environment.
Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system.
ME Systems Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1, respectively). Anyone connecting additional equipment to the Kick 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
1.4
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.
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Training and Documentation
1.4.2
Documentation
Intended Audience This user guide is intended for surgeons and hospital staff.
Relevant System Configurations The information in this guide is relevant for the system configurations below: System Configuration
Art.-No.
Kick Navigation Station
18070
Kick Upgrade Navigation Sta18077 tion
Kick EM Navigation Station
Device
Art.-No.
Monitor Cart
18071
Camera Cart
18072
Monitor Cart
18071
Kolibri Mobile Camera Stand 2.0
19801
Kolibri Spectra Camera Kit
18117
Monitor Cart
18071
EM Tracking Unit
18092
18090
NOTE: All device article numbers are listed on the system plates on the back side of the Monitor Cart. For information on the use of the Kolibri Mobile Camera Stand 2.0 and the Kolibri Spectra Camera Kit, refer to the relevant System User Guides and Technical User Guides that were delivered with those devices.
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.
Abbreviations “EM” is used to abbreviate electromagnetic in this user guide.
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GENERAL INFORMATION
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 instruments
System User Guides
Comprehensive information on system setup
Technical User Guide
Detailed technical information on the system, including specifications and compliances
NOTE: Not all above-mentioned user guides are available or relevant for all Brainlab products.
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Training and Documentation
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SYSTEM OVERVIEW
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SYSTEM OVERVIEW
2.1
System Components
General Information Kick is a touchscreen-operated planning and navigation system designed for pre- and intraoperative use. All system components are suitable for continuous use during surgical procedures. The Kick system is a navigation platform used for image guided surgery, consisting of: • A tracking system • A computer unit that runs the software • A display unit to display the navigation, including touch functionality for the user to interact with the software
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 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.
Electromagnetic Tracking Electromagnetic (EM) tracking uses an EM Field Generator to create a known volume of a varying magnetic field. This field induces voltage into coils located inside the EMinstruments. From the strength and phase of the induced voltages, the position of the instrument inside the area of interest is calculated. Brainlab software applications use this tracking unit input to display the three-dimensional position of the EM instruments relative to the EM Patient Reference.
Electromagnetic Compatibility Special precautions regarding electromagnetic compatibility (EMC) must be installed and put into service according to the EMC information provided in this guide and the System User Guide.
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System Components
Components
③
②
①
④
⑤
⑥
Figure 1
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No.
Component
①
Telescopic camera post
②
Camera
③
Camera Cart
④
Monitor Cart
⑤
Touchscreen
⑥
Monitor post
Technical User Guide Rev. 1.3 Kick, Kick EM Ver. 1.1
SYSTEM OVERVIEW
Components - Kick EM ⑦ ②
③ ④⑤ ⑥
⑧
⑨
①
Figure 2 No.
Component
①
EM Field Generator Fixation Plate
②
EM Field Generator
③
EM Field Generator Positioning Arm
④
EM Base Station
⑤
EM power supply
⑥
Kick EM Holder
⑦
Monitor Cart
⑧
Touchscreen
⑨
Monitor post
EM Tracking unit components
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Monitor Cart
2.2
Monitor Cart
2.2.1
Components
Cart Components
④ ③ ②
⑤
⑥
⑦ ⑧
① Figure 3
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No.
Component
①
Wheels
②
• Monitor Cart handle • Monitor release trigger (back side of handle, not visible)
③
Monitor hinge
④
Touchscreen
⑤
Monitor cable
⑥
Cable hooks
⑦
On/off button
⑧
Monitor Cart base, containing: • Medical computer unit • Connection panel
Technical User Guide Rev. 1.3 Kick, Kick EM Ver. 1.1
SYSTEM OVERVIEW
Monitor Components
③
②
①
Figure 4 No.
Component
①
Monitor release trigger (back side of monitor handle)
②
Home button NOTE: The function of this button may vary depending on the software application. See relevant Software User Guide for more information.
③
USB ports (top of monitor, covered by flap)
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