Brainlab KICK 2 User manual

KICK 2
SPECTRA
CAMERA CART
DPS
System and Technical User Guide
Revision 1.3
Copyright 2018, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................7
1.1 Contact Data and Legal Information ..............................................................................................7
1.1.1 Legal Information ...............................................................................................................................9
1.2 Symbols..............................................................................................................................................10
1.2.1 Hardware Symbols...........................................................................................................................11
1.3 Intended Use......................................................................................................................................13
1.4 Compatibility with Medical Devices .............................................................................................15
1.4.1 Brainlab Medical Devices..................................................................................................................15
1.5 Training and Documentation..........................................................................................................16
2 CAMERA CART OVERVIEW.....................................................................................17
2.1 Camera Cart Components..............................................................................................................17
2.1.1 Overview...........................................................................................................................................17
2.1.2 Spectra Camera Components (DPS) ...............................................................................................18
2.2 Camera................................................................................................................................................20
2.2.1 Overview...........................................................................................................................................20
2.2.2 Range of Motion...............................................................................................................................22
3 USING THE CAMERA CART.....................................................................................23
3.1 Setup...................................................................................................................................................23
3.1.1 Camera Cart Position........................................................................................................................23
3.1.2 OR Setup.........................................................................................................................................25
3.1.3 Operating Position............................................................................................................................26
3.2 Proper System Handling.................................................................................................................27
3.3 Cabling................................................................................................................................................29
3.4 Camera Use........................................................................................................................................31
3.4.1 Adjusting the Camera Cart...............................................................................................................33
3.5 Spectra Camera LEDs and Acoustic Signals.............................................................................37
3.6 Shutdown...........................................................................................................................................39
4 ASSEMBLY, TRANSPORT AND STORAGE................................................41
4.1 Protection Cover...............................................................................................................................41
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4.2 Transport Outside of the Hospital.................................................................................................42
4.2.1 Assembling the Camera Cart ...........................................................................................................44
4.2.2 Disassembling the Camera Cart.......................................................................................................47
4.3 Transport Inside the Hospital ........................................................................................................48
4.3.1 Proper Transport Procedure.............................................................................................................49
4.4 Parking and Storage........................................................................................................................51
4.4.1 Parking the Cart...............................................................................................................................52
4.4.2 Storage ............................................................................................................................................53
4.4.3 Long-term Storage ...........................................................................................................................54
5 CLEANING..................................................................................................................................55
5.1 Preparing for Cleaning....................................................................................................................55
5.1.1 Cleaning the Camera Cart................................................................................................................57
5.2 Cleaning the Camera Protection Cover.......................................................................................58
5.3 Cleaning the Camera Cart Transport Cases...............................................................................59
6 ELECTRICAL SAFETY....................................................................................................61
6.1 Introduction to Electrical Safety....................................................................................................61
6.2 Recurrent Test Requirements........................................................................................................62
6.2.1 Overview...........................................................................................................................................62
6.2.2 Testing Overview..............................................................................................................................63
6.2.3 Safety Inspection Form - Recurrent Tests.........................................................................................64
6.3 Performing Tests ..............................................................................................................................66
6.3.1 Protective Earth Resistance..............................................................................................................66
6.3.2 Equipment Leakage Current.............................................................................................................67
6.4 Electrical Safety Test – Medical Electrical System ...................................................................68
6.4.1 Overview...........................................................................................................................................68
6.4.2 Testing Medical Electrical Systems...................................................................................................69
6.4.3 Safety Inspection Form - Medical Electrical Systems .......................................................................70
6.4.4 Touch Current for Medical Electrical Systems...................................................................................72
7 COMPLIANCES AND SPECIFICATIONS.......................................................73
7.1 Electrical Standards.........................................................................................................................73
7.2 Environmental Requirements........................................................................................................74
7.2.1 Transport/Storage and Operating Conditions ....................................................................................74
7.3 Camera Cart Specifications ...........................................................................................................75
7.3.1 Physical Characteristics....................................................................................................................75
7.3.2 Technical Specifications ...................................................................................................................76
7.4 Compliances......................................................................................................................................77
7.4.1 Electromagnetic Emissions ...............................................................................................................77
7.4.2 General Electromagnetic Immunity...................................................................................................78
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7.4.3 Electromagnetic Immunity................................................................................................................79
7.4.4 RF Communications Equipment.......................................................................................................81
7.4.5 Tested Cables ..................................................................................................................................82
8 MAINTENANCE......................................................................................................................83
8.1 Inspections ........................................................................................................................................83
8.1.1 Overview...........................................................................................................................................83
8.1.2 Weekly and Monthly Inspections......................................................................................................85
8.1.3 Annual Inspection by Brainlab..........................................................................................................86
8.2 Malfunctions and Return Instructions.........................................................................................87
8.2.1 Overview...........................................................................................................................................87
8.2.2 Return Instructions...........................................................................................................................88
9 TROUBLESHOOTING......................................................................................................89
9.1 About Troubleshooting ...................................................................................................................89
9.2 Possible Occurrences.....................................................................................................................90
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TABLE OF CONTENTS
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1 GENERAL INFORMATION
1.1 Contact Data and Legal Information
Manufacturer
This product is manufactured by Brainlab and exclusively distributed by DePuy Synthes.
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
Distributor
DePuy Synthes Sales, Inc.
325 Paramount Drive
Raynham, MA 02767
USA
Support
If you cannot find information you need in this guide, or if you have questions or problems, contact
support:
Region Telephone and Fax
United States, Canada, Central and South Ameri-
ca Tel: [phone]
Europe, Middle East, Africa Tel: [phone]
Asia, Australia Tel: [phone]
Support and service of the system may be done either by Brainlab service and support personnel
or personnel of third parties certified or authorized by Brainlab. Within this manual, both
possibilities are included when Brainlab support or service is mentioned.
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 Spectra Camera Cart 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 Spectra Camera Cart 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.
GENERAL INFORMATION
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Feedback
Despite careful review, this user guide may contain errors. Please contact us at
user[email protected] if you have improvement suggestions.
Contact Data and Legal Information
8 System and Technical User Guide Rev. 1.3 Kick 2 Spectra Camera Cart DPS

1.1.1 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.
Patent Information
This product may be covered by one or more patents or pending patent applications. For details,
see: www.brainlab.com/patent
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
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 US
US federal law restricts this device to sale by or on the order of a physician.
GENERAL INFORMATION
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1.2 Symbols
Warnings
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
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1.2.1 Hardware Symbols
Symbols on Hardware Components
The following symbols may be found on the Kick 2 Spectra Camera Cart:
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 humidi-
ty 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
GENERAL INFORMATION
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Symbol Explanation
Serial Number
Article number
Date of manufacture
Manufacturer
IPXY Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects
• Y = Protection against ingress of liquid
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
ANSI Z136.1 (2000), IEC 60825-1 (2001)
FDA/CDRH 21 CFR 1040.10 and 1040.11 except for deviations pursuant to
Laser Notice No. 50, dated July 26, 2001.
Danger of tilting: Do not move cart when brakes are locked or if device is
blocked by obstacles
Standby switch to bring the device into standby mode.
Consult accompanying documentation
Hardware Symbols
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1.3 Intended Use
Intended Use of Kick 2 Spectra Camera Cart
Kick 2 Spectra Camera Cart is intended to be used as mobile optical tracking device offering
tracking data at defined interface(s) with defined performance specification in the intended use
environment.
Patient Population
The intended patient population depends on the application software handling the provided
tracking data. For details please refer to the respective documentation of the navigation station.
Intended User Profile
The following describes the intended users of the Camera Cart and their respective tasks.
Clinical team:
• Non-sterile preparation and set-up prior to surgery.
• Non-sterile usage during surgery e.g., re-positioning of cart.
• Shut down, tidying and storage of equipment after surgery.
NOTE: The clinical team profile may vary depending on the software application. For further
information, refer to the relevant Software User Guide.
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-authorized service:
• Installation of device including unpacking and transportation of device.
• Training of users on device.
• Troubleshooting and repair of device.
Place of Use
The Camera Cart is only for use indoors, in a professional healthcare facility.
Frequently Used Functions
The following are frequently used functions of the Camera Cart:
• Moving and positioning device before and after surgery
• Activation of positioning laser
• Unsterile re-positioning of the device during surgery
• Start up/shut down
• Cleaning of device
• Preparation for travel and packing travel kit
GENERAL INFORMATION
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Careful Hardware Handling
Only trained medical personnel may operate Camera Cart components and accessory
instrumentation.
Camera Cart components and accessory instrumentation comprise precise mechanical
parts. Handle them carefully. Dropping or jolting the camera may cause miscalibration.
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.
Intended Use
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1.4 Compatibility with Medical Devices
1.4.1 Brainlab Medical Devices
Brainlab Hardware
Contact Brainlab-authorized support if you have any questions regarding hardware compatibility.
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.
GENERAL INFORMATION
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1.5 Training and Documentation
Terminology
The information in this guide refers to Kick 2 Spectra Camera Cart (article number 18188).
Unless otherwise specified, the Kick 2 Spectra Camera Cart shall be referred to as “Camera
Cart” in this user guide.
Training
To ensure safe and appropriate use, before using the Camera Cart all users should participate in
a training program held by a Brainlab-authorized representative.
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
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 Details on cleaning, disinfecting and sterilizing instruments
System and Technical User
Guides
• Comprehensive information on system setup
• Detailed technical information on the system, including specifica-
tions and compliances
NOTE: Available user guides vary depending on the Brainlab product. If you have questions
regarding the user guides you received, contact Brainlab-authorized support.
Training and Documentation
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2 CAMERA CART OVERVIEW
2.1 Camera Cart Components
2.1.1 Overview
General Information
The Camera Cart is a mobile, optical tracking device. It can be used as part of a navigation
station for Image Guided Surgery (IGS).
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.
The intended medical indication depends on the application software handling the provided
tracking data. For details refer to the respective documentation of the navigation station.
Optical Tracking
Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light.
• Users position the camera unit so the area of interest is visible.
• 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.
CAMERA CART OVERVIEW
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2.1.2 Spectra Camera Components (DPS)
Components
①
③
⑧
⑥
②
⑦
⑤
④
Figure 1
No. Component
①Camera Cart base
②Cable hooks
③• Telescopic post
• Spiral camera cable (not visible)
④Camera adjustment handle
⑤Camera
⑥Camera hinge
⑦Camera handle
⑧Clamping lever
Spectra Camera Components (DPS)
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Detachable Components
Component Article Number
Kick Camera Protection Cover DPS 18084-01
Kick Camera Unit N/A
Kick Camera Telescopic Post Complete 18072-09
CAMERA CART OVERVIEW
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2.2 Camera
2.2.1 Overview
Camera Components
⑤
②⑥
⑦
①
③
④
Figure 2
No. Component
①Camera release trigger
②Camera handle
③Positioning laser
④Illuminator filter
⑤Lens
⑥Camera adjustment handle
⑦Laser trigger
NOTE: The camera does not contain any user-serviceable parts.
Camera
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