BRAINLAB
KICK 2 NAVIGATION STATION System and Technical User Guide Rev 1.3
System and Technical User Guide
104 Pages
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KICK 2 NAVIGATION STATION
System and Technical User Guide Revision 1.3 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 1.3.1 Hardware Symbols ...11
1.4 Intended Use...13 1.5 Compatibility with Medical Devices ...15 1.5.1 Brainlab Medical Devices ...15
1.6 Training ...16 1.7 Documentation ...17
2 KICK 2 OVERVIEW ...19 2.1 System Components ...19 2.1.1 Overview ...19 2.1.2 Monitor Cart Components ...20
2.2 Monitor ...23 2.2.1 Overview ...23 2.2.2 Range of Motion...25
2.3 Monitor Cart Ventilation ...26
3 USING KICK 2 ...27 3.1 System Setup ...27 3.1.1 Overview ...27 3.1.2 OR Setup ...29
3.2 Proper System Handling ...30 3.2.1 Overview ...30 3.2.2 Moving Parts ...32
3.3 Turning On Kick 2 ...33 3.4 Turning Off Kick 2...34 3.5 Sterile Use ...35 3.5.1 Sterile Kick Monitor Drape...35
3.6 System Connections...37 System and Technical User Guide Rev. 1.3 Kick 2 Navigation Station
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TABLE OF CONTENTS
3.6.1 Third-Party Connections...37 3.6.2 Back Panel Connections ...39 3.6.3 Tracking Unit ...40 3.6.4 Optional Components...41
3.7 Cabling ...43 3.7.1 Overview ...43 3.7.2 Cable Storage ...45
4 ASSEMBLY, TRANSPORT AND STORAGE...47 4.1 Protection Cover ...47 4.2 Transport Outside of the Hospital...48 4.2.1 Overview ...48 4.2.2 Assembling the Kick 2 ...50 4.2.3 Disassembling and Transporting the Kick 2...53
4.3 Proper Transport Inside the Hospital ...56 4.4 Parking and Storage ...58 4.4.1 Overview ...58 4.4.2 Parking Kick 2 ...59 4.4.3 Storage ...60 4.4.4 Long Term Storage...61
5 CLEANING ...63 5.1 Cleaning the Monitor Cart...63 5.2 Cleaning the Monitor Protection Cover ...65 5.3 Cleaning Transport Cases ...66
6 ELECTRICAL SAFETY...67 6.1 Equipment Classification...67 6.2 Recurrent Test Requirements ...68 6.2.1 Overview ...68 6.2.2 Test Steps ...69 6.2.3 Safety Inspection Form – Recurrent Tests...70
6.3 Performing Tests ...72 6.3.1 Protective Earth Resistance ...72 6.3.2 Equipment Leakage Current...73
6.4 Electrical Safety Test – Medical Electrical System ...74 6.4.1 Overview ...74 6.4.2 Testing Medical Electrical Systems...75 6.4.3 Safety Inspection Form – Medical Electrical Systems...76 6.4.4 Touch Current for Medical Electrical Systems...78
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TABLE OF CONTENTS
7 COMPLIANCES AND SPECIFICATIONS ...79 7.1 Electrical Standards ...79 7.2 Environmental Requirements ...80 7.2.1 Transport/Storage and Operating Conditions ...80
7.3 System Specifications ...81 7.3.1 Physical Characteristics ...81 7.3.2 Technical Specifications ...82
7.4 Compliances ...83 7.4.1 Electromagnetic Emissions ...83 7.4.2 General Electromagnetic Immunity...84 7.4.3 Electromagnetic Immunity ...85 7.4.4 RF Communications Equipment ...87 7.4.5 Tested Cables ...88 7.4.6 Hospital Network ...89
7.5 Power Plugs ...91
8 MAINTENANCE...93 8.1 Inspections ...93 8.1.1 Overview ...93 8.1.2 Inspection Periods...94 8.1.3 Annual Inspection by Brainlab ...95
8.2 Air Filter Exchange...96 8.3 Malfunctions and Return Instructions ...97 8.3.1 Return Instructions ...98
9 TROUBLESHOOTING ...99 9.1 Troubleshooting the Kick 2 ...99
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TABLE OF CONTENTS
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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
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
Expected Service Life Brainlab provides a minimum of eight years of service for platforms. During this period of time, spare parts as well as field support are offered. The Kick 2 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 2 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.
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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. • 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 United States and other countries.
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
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 shows 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, Kick 2 is a Class IIb product. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
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
Sales in the US US federal law restricts this device to sale by or on the order of a physician.
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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 conditions: 1. This device may not cause harmful interference. 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 Kick 2. Contact Brainlab support for 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.
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GENERAL INFORMATION
1.3.1
Hardware Symbols
Symbols on Hardware Components The following symbols may be found on Kick 2: Symbol
Explanation
Caution
Potential equalization point
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
Serial number
Article number
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Hardware Symbols
Symbol
Explanation
Date of manufacture
Manufacture
IPXY
Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects • Y = Protection against ingress of liquid
Laser warnings for DVD Drive for Kick 2: CLASS 1 LASER PRODUCT CAUTION - CLASS 3B LASER RADIATION WHEN OPEN AVOID EXPOSURE TO THE BEAM
Weight
Prescription only
Regulatory compliance mark
Unique device identification
Danger of tilting: Do not move when brakes are locked or if device is blocked by obstacles.
Power switch to power on the device.
Consult accompanying documentation
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GENERAL INFORMATION
1.4
Intended Use
Intended System Use Kick 2 is intended for use as a mobile computing platform hosting one or more software applications. Kick 2 facilitates the display and exchange of, as well as the interaction with data. Kick 2 also offers interaction with external/additional devices or components within the defined performance specification while used in the intended use environment. Integrating a suitable tracking unit and using a suitable application software, Kick 2 can be used as navigation station.
Intended User Profile The following describes the intended users of the system and their respective tasks. Clinical team: • Non-sterile preparation and set-up prior to surgery • Non-sterile handling of device during surgery e.g., re-positioning of cart • Sterile or non-sterile interaction with videos, images and data • Shut down, tidying and storage of equipment after surgery Cleaning staff: • Cleaning of device after shut down Hospital technician: • Maintenance • Oversee electrical safety of device during service life • Disposal of the device after service life Brainlab service: • Installation of device including unpacking and transportation of device • Training of users on device • Troubleshooting and repair of device
Patient Population The intended patient population consists of patients that could be treated via Brainlab application software that are released for the Kick 2. For details refer to the relevant Software User Guide.
Place of Use The system is only for use indoors, in a professional healthcare facility.
Frequency of Use The frequency of use is defined to be between once per month and several times per week.
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.
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Intended Use
Frequently Used Functions The following are frequently used functions of Kick 2: • Moving and positioning device before and after surgery • Connecting/disconnecting 3rd-party devices • Transferring patient data to the device • Unsterile re-positioning of the device during surgery • Sterile use of touchscreen • Start up/shut down • Cleaning of device • Preparation for travel and packing travel kit
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.
Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system.
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
Compatibility with Medical Devices
1.5.1
Brainlab Medical Devices
Compatible Brainlab Medical Components Kick 2 is compatible with Kick Monitor Drape.
Compatible Optional Accessories Kick 2 is compatible with an optional Converter Kit DVI to S-Video.
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.
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Training
1.6
Training
Brainlab Training Before using the system, Brainlab recommends that all users should participate in a training program held by a Brainlab 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.
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.
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GENERAL INFORMATION
1.7
Documentation
Terminology Unless otherwise specified, the Kick 2 Navigation Station shall be referred to as “Kick 2” in this user guide.
Intended Audience This user guide is intended for surgeons and hospital staff.
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
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
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.
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Documentation
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KICK 2 OVERVIEW
2
KICK 2 OVERVIEW
2.1
System Components
2.1.1
Overview
Kick 2 Kick 2 is a mobile Medical Electrical (ME) device. It consists of a Monitor Cart, including a medical computer unit (MCU) and a base display including touchscreen, with a suitable tracking unit. Moreover, it offers interfaces necessary for exchange of data with additional devices or components. The Monitor Cart acts as a “base station” for connecting suitable tracking units. The monitor can be declined to receive a good viewing angle for the user. For sterile use, the Kick Monitor Drape shall be used.
Operating Principle Using the MCU, Kick 2 processes information data that can be displayed on the display or provided at interface connections on the user panel. A projected capacitive touchscreen in the display enables the user to interact with the information data. Integrating a suitable tracking unit and using suitable application software, Kick 2 can be used as navigation station.
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Monitor Cart Components
2.1.2
Monitor Cart Components
Monitor Cart Components
④ ③ ⑤
②
⑥
⑦ ⑧
① Figure 1
20
No.
Component
①
Wheels
②
Monitor Cart handle (release trigger located on back side of handle, not visible)
③
Monitor hinge
④
Touchscreen
⑤
Monitor cable (not visible in image)
⑥
Monitor post with cable hooks
⑦
Power button
⑧
Monitor Cart base, containing: • Medical computer unit • Connection panel
System and Technical User Guide Rev. 1.3 Kick 2 Navigation Station
KICK 2 OVERVIEW
Connection Panel
③ ④ ⑤ ⑥ ⑦ ②
⑧
①
⑨
Figure 2
No.
Component
①
Mains power
②
Potential equalization
③
S-Video In
④
Video In
⑤
Hospital Network
⑥
Tracking unit
⑦
USB 2.0
⑧
USB 3.0
⑨
Microscope/Video Out
Tracking Unit The Kick 2 (article number 18170) can be used with either of the following components: Component
Article Number
Kick 2 Spectra Camera Cart
18178
Kick 2 Vega Camera Cart
18172
Detachable Components The Kick 2 (article number 18170) comprises the following components: Component
Article Number
Display with hinge (“monitor”)
18171-18
Monitor post
18071-04
Monitor protection cover
18174-02
DVD drive for Kick 2.0 (optional)
18176
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