BRAINLAB
KICK and KICK EM ver 1.1 System User Guide Rev 1.4
System User Guide
142 Pages
Preview
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KICK KICK EM Version 1.1
System User Guide Revision 1.4 Copyright 2016, Brainlab AG Germany. All rights reserved.
TABLE OF CONTENTS
TABLE OF CONTENTS GENERAL INFORMATION ...7 Contact Data and Legal Information ...7 Contact Data ...7 Legal Information ...9
Symbols ...11 Symbols Used in the Guide...11 Hardware Symbols...12
Intended Use ...15 Compatibility with Medical Devices ...17 Training and Documentation ...18 Training ...18 Documentation...19
SYSTEM OVERVIEW ...21 System Components ...21 System Setup ...24 Precautions ...24 Kick System Setup ...25 Kick EM System Setup...26 OR Setups ...27
Proper System Handling ...29 Inspections ...32 Overview...32 Weekly and Monthly Inspections ...33 Annual Electrical Safety Inspection ...34
Malfunctions and Return Instructions ...35 Malfunctions...35 Return Instructions ...36
MONITOR CART ...37 Components ...37 Monitor ...39 Range of Motion...41 Moving Parts ...42
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TABLE OF CONTENTS
Monitor Cart Ventilation ...43 Connections ...44 3rd-Party Connections ...44 Back Panel Connections ...46
Cabling ...48 LED Indications ...51
CAMERA CART ...53 Components ...53 Cart Components ...53 Camera Components ...55
Cabling ...56 Camera Use ...59 Overview...59 Range of Motion...61 Operating Position ...62 Adjusting Camera Cart...63
LEDs and Acoustic Signals ...67
EM TRACKING UNIT ...69 Components ...69 Connecting and Disconnecting EM Tracking Unit Components ...75 Cabling Precautions ...75 EM Base Station ...76 EM Instruments...78
Positioning EM Tracking Unit in the OR ...80 Patient Positioning ...87
USING THE SYSTEM ...89 Turning the System On ...89 System Shutdown ...91 Sterile Use ...92 Sterile Kick Monitor Drape...92 Sterile Touchpen ...95
ASSEMBLY, TRANSPORT AND STORAGE ...99 Assembly ...99 Assembling the Camera Cart ...99
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TABLE OF CONTENTS
Assembling the Monitor Cart ...102
Protection Covers ...106 Transport Outside of the Hospital ...108 General Information ...108 Transporting the Kick System using the Transport Cases ... 111 Transporting the EM Tracking Unit using Transport Cases...113
Transport Inside the Hospital ...116 Precautions ...116 Transporting Kick EM Components on the Kick EM Holder ... 117 Proper Transport Procedure...123
Parking and Storage ...127 Brakes...127 Parking the Carts ...128 Storage ...129 Long Term Storage ...130
CLEANING ...131 Precautions ...131 Kick System ...133 Protection Covers ...135 Cleaning the Monitor’s Protection Cover ...135 Cleaning the Camera’s Protection Cover ...136
Transport Cases ...137
INDEX ...139
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TABLE OF CONTENTS
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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 the 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 manual may contain errors. Please contact us at [email protected] if you have suggestions as to how we can improve this manual.
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Contact Data and Legal Information
Manufacturer Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany
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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. • Kolibri™ 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. See https:// www.brainlab.com/patent/ for more details.
CE Label • The CE label shows that the Brainlab product complies with the essential requirements of Council Directive 93/42/EEC, the Medical Device Directive (MDD). • According to the principles set out in the MDD, 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/ For more information or recycling instructions, please contact Brainlab.
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.
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Contact Data and Legal Information
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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GENERAL INFORMATION
1.2
Symbols
1.2.1
Symbols Used in the 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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Symbols
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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GENERAL INFORMATION
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 switch to bring the device into standby mode.
Consult the operating instructions
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Symbols
Symbol
Explanation
Consult accompanying documentation
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GENERAL INFORMATION
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.
Place of Use The system is only for use indoors, in a hospital operating room.
Frequency of Use The frequency of use is defined to be between once a month and several times per week.
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 refer to the relevant Software User Guide.
Intended User Profile The following describes the intended users of the system and their respective tasks: • Trained hospital personnel (e.g., nurses) are responsible for setting up the system before the surgical procedure and for removing the system after the surgical procedure. - System setup and removal includes: moving and positioning, plugging cables in/out, startup/ shutdown, cleaning of the system, connecting/disconnecting 3rd party devices. • Sterile nurse is responsible for maintaining sterility during surgery, including the draping of devices. • Surgeons and/or surgical assistants steer and interact with the Brainlab software running on the system using the system touchscreen. For detailed information on use of the software, see the relevant Software User Guide. • Brainlab personnel are responsible for system maintenance and support.
Essential Performance As essential performance is defined by the clinical function(s), it is dependent on the Brainlab application used and the clinical procedure. Consult the corresponding Software User Guide to see if an essential performance is defined, and if so, which essential performance.
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.
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Intended Use
Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system.
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GENERAL INFORMATION
1.4
Compatibility with Medical Devices
Compatible Brainlab Medical Instruments Kick and Kick EM are compatible with: • Sterile Touchpen Kick EM is compatible with: • EM instruments (see Instrument User Guide and Software User Guide)
Other Brainlab Instruments Additional instrumentation may become available after release of this manual. Contact Brainlab support if you have any questions regarding instrument compatibility with Brainlab software. Only use instruments and spare parts specified by Brainlab. Using unauthorized instruments/spare parts may adversely affect safety and/or effectiveness of the medical device and endanger safety of patient, user and/or environment.
Compatible Non-Brainlab Medical Devices Medical Device
Manufacturer
Kick Monitor Drape
Microtek Medical, Inc. 512 Lehmberg Road Columbus, MS 39702
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Training and Documentation
1.5
Training and Documentation
1.5.1
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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GENERAL INFORMATION
1.5.2
Documentation
Terminology Unless otherwise specified, both the Kick and Kick EM shall be referred to as the “Kick system” in this user guide.
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 Sta18078 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
Kick EM Tracking Add-On for Kick
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 Kolibri Mobile Camera Stand 2.0 and Kolibri Spectra Camera Kit, refer to the relevant System User Guides and Technical User Guides that were delivered with those devices.
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 It is considered incorrect use to disregard information in the user guides, in particular warnings and cautions.
Abbreviations “EM” is used to abbreviate electromagnetic in this user guide.
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
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Training and Documentation
User Guide
Contents
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 specifications and compliances
NOTE: Available user guides vary depending on the Brainlab product. If you have questions regarding the user guides you received, contact Brainlab support.
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SYSTEM OVERVIEW
2
SYSTEM OVERVIEW
2.1
System Components
Kick System Kick is a navigation platform used for Image Guided Surgery (IGS) incorporating: • A tracking system (for optical tracking, see page 53, for electromagnetic tracking, see page 69) • A computer unit that runs the software (refer to the Technical User Guide, Kick and Kick EM) • A display unit to display the navigation, including touch functionality for the user to interact with the software (see page 37) Kick provides a touchscreen and buttons for user interaction. Additionally, the system offers several PC interfaces for connecting video sources, data transfer devices, network integration, or other 3rd-party devices. The camera can be adjusted in height by usage of the telescopic post and further in rotation around vertical and horizontal axis to achieve a good tracking position.
Basis for 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. • Brainlab software applications use the camera input to calculate the relative three-dimensional positions of the instruments and the patient reference arrays.
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 or to the EM Holder on Kick. EM Field Generator must be fixed to either the Fixation Plate or the Positioning Arm when in use. The monitor can be declined to receive a good viewing angle for the user. For sterile use, the Kick Monitor drape shall be used or the Sterile Touchpen.
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.
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