Brainlab KICK 2 User manual

KICK 2
NAVIGATION
STATION
Version 1.1
System and Technical User Guide
Revision 1.0
Date of issue: 2021-05-19 (ISO 8601)
Copyright 2021, Brainlab AG Germany. All rights reserved.

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 Software Environment.....................................................................................................................15
1.6 Documentation..................................................................................................................................21
2 SYSTEM OVERVIEW........................................................................................................23
2.1 System Components .......................................................................................................................23
2.2 System Setup ....................................................................................................................................25
2.3 WLAN Stick Assembly.....................................................................................................................27
2.4 Proper System Handling.................................................................................................................28
2.5 System Shutdown ............................................................................................................................29
3 MONITOR CART...................................................................................................................31
3.1 Monitor Cart Components..............................................................................................................31
3.2 Air Filter Exchange...........................................................................................................................34
3.3 Adjusting the Touchscreen............................................................................................................35
3.4 LED Indications.................................................................................................................................36
4 CAMERA CART.....................................................................................................................37
4.1 Camera Cart Components..............................................................................................................37
4.2 Camera Cart Setup...........................................................................................................................40
4.2.1 Camera Cart Position........................................................................................................................40
4.3 Adjusting the Camera Cart.............................................................................................................41
4.4 Using the Camera.............................................................................................................................43
4.5 LEDs and Acoustic Signals............................................................................................................44
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5 EM TRACKING UNIT.........................................................................................................47
5.1 EM Tracking Unit Components......................................................................................................47
5.2 EM Tracking Unit Setup...................................................................................................................50
5.2.1 Overview...........................................................................................................................................50
5.3 Using the EM Tracking Unit............................................................................................................55
5.4 LEDs and Acoustic Signals............................................................................................................58
6 ASSEMBLY, TRANSPORT AND STORAGE................................................59
6.1 Assembling the Monitor Cart.........................................................................................................59
6.2 Assembling the Camera Cart.........................................................................................................63
6.3 Transport Outside the Hospital .....................................................................................................66
6.3.1 Overview...........................................................................................................................................66
6.3.2 Disassembling and Transporting the Monitor Cart............................................................................68
6.3.3 Disassembling the Camera Cart.......................................................................................................71
6.4 Parking and Storage........................................................................................................................72
6.5 Transporting the Monitor Cart Inside the Hospital....................................................................73
6.6 Transporting the Camera Cart Inside the Hospital....................................................................75
6.7 Transporting the EM Tracking Unit...............................................................................................77
7 CLEANING..................................................................................................................................79
7.1 Preparing for Cleaning....................................................................................................................79
7.2 Cleaning the Monitor Cart...............................................................................................................80
7.3 Cleaning the Camera Cart...............................................................................................................81
7.4 Cleaning the EM Tracking Unit......................................................................................................83
7.5 Cleaning Transport Cases..............................................................................................................84
8 ELECTRICAL SAFETY....................................................................................................85
8.1 Equipment Classification................................................................................................................85
8.2 Recurrent Test Requirements........................................................................................................86
8.2.1 Overview...........................................................................................................................................86
8.2.2 Test Steps ........................................................................................................................................87
8.2.3 Safety Inspection Form – Recurrent Tests........................................................................................89
8.3 Performing Tests ..............................................................................................................................91
8.3.1 Protective Earth Resistance..............................................................................................................91
8.3.2 Equipment Leakage Current.............................................................................................................92
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8.3.3 Applied Part Leakage Current (Type BF) (for Optional EM Tracking Unit) ........................................95
8.4 Electrical Safety Test – Medical Electrical System ...................................................................96
8.4.1 Overview...........................................................................................................................................96
8.4.2 Testing Medical Electrical Systems...................................................................................................97
8.4.3 Safety Inspection Form – Medical Electrical Systems (Monitor Cart)................................................98
8.4.4 Touch Current for Medical Electrical Systems...................................................................................99
9 COMPLIANCES AND SPECIFICATIONS.....................................................101
9.1 Electrical Standards.......................................................................................................................101
9.2 Weight and Dimensions................................................................................................................102
9.2.1 Physical Characteristics..................................................................................................................102
9.3 Technical Specifications...............................................................................................................105
9.4 Environmental Requirements......................................................................................................108
9.4.1 Transport/Storage Conditions..........................................................................................................108
9.5 Compliances....................................................................................................................................110
9.5.1 Electromagnetic Emissions .............................................................................................................110
9.5.2 Electromagnetic Immunity, Kick 2 Navigation Station System ........................................................111
9.5.3 RF Communications Equipment.....................................................................................................114
9.5.4 Tested Cables ................................................................................................................................115
9.5.5 Supported Resolutions...................................................................................................................118
9.5.6 Hospital Network............................................................................................................................121
10 MAINTENANCE................................................................................................................123
10.1 Inspections....................................................................................................................................123
10.2 Malfunctions and Return Instructions.....................................................................................124
10.2.1 Malfunctions..................................................................................................................................124
10.2.2 Return Instructions.......................................................................................................................125
11 APPENDIX..............................................................................................................................127
11.1 Firewall Settings...........................................................................................................................127
INDEX..................................................................................................................................................133
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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 Email
United States, Canada, Central
and South America Tel: [phone]
Fax: [phone] [email protected]
Brazil Tel: [phone] [email protected]
UK Tel: [phone]
[email protected]
Spain Tel: [phone]
France and French-speaking
regions Tel: [phone]
Africa, Asia, Australia, Europe Tel: [phone]
Fax: [phone]
Japan Tel: [phone]
Fax: [phone]
Feedback
Despite careful review, this user guide may contain errors. Please contact us at
user[email protected] if you have improvement suggestions.
Manufacturer
Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
GENERAL INFORMATION
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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 trademark of Brainlab AG.
•Kick®is a trademark of Brainlab AG.
Non-Brainlab Trademarks
•Intel®is a trademark of Intel Corporation.
•Microsoft®and Windows®are trademarks of Microsoft Corporation.
•Realtek®is a trademark of Realtek Semiconductor Corporation.
•NVIDIA®is a trademark of NVIDIA Corporation.
•ASMedia®is a trademark of ASMedia Technology Inc.
•Kontron®is a trademark of Kontron Europe GmbH.
• Yuan is a trademark of YUAN High-Tech Development Co., Ltd.
•esd®is a trademark of esd electronics gmbh.
•FTDI®is a trademark of Future Technology Devices International Ltd.
•Edimax®is a trademark of EDIMAX Technology Co., Ltd.
•Innodisk®is a trademark of Innodisk Corporation.
•DisplayPort™and the DisplayPort™logo are trademarks owned by the Video Electronics
Standards Association (VESA®).
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 General
Safety and Performance Requirements of European Regulation 2017/745, the
Medical Device Regulation (“MDR”).
Kick 2 Navigation Station is a Class IIb product according to the rules estab-
lished by the MDR.
Disposal Instructions
When a medical device reaches the end of its functional life, clean the device of all biomaterial/
biohazards and safely dispose of the device in accordance with applicable laws and regulations.
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 or relevant substances that could be present in the medical equipment,
visit:
www.brainlab.com/sustainability
Legal Information
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Disposal of Package
The device packaging was developed in a way that its components (e.g. plastic, metal, cardboard,
wood) can be separated and disposed of according to the country-specific waste separation
guidelines.
Report Incidents Related to This Product
You are required to report any serious incident that may have occurred related to this product to
Brainlab, and if within Europe, to your corresponding national competent authority for medical
devices.
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
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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 below symbols may be found on the system.
Symbol Explanation
Manufacturer
Manufacturer's serial number
Reference (article) number
NOTE: Indicates Brainlab's product number.
Date of manufacture
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
U.S. federal law restricts this device to sale by or on order of a physician
Switch to bring the device into standby mode
Keep hands clear (pinch point hazard)
Unique Device Identifier
Refer to instruction manual or booklet
Symbols
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Symbol Explanation
Laser radiation emitted from aperture
Laser activation
Do not stare into beam
Class 2 laser product
max. output < 1 mW wavelength 635-670 nm
ANSI Z136.1 (2014), IEC 60825-1 (2014)
FDA/CDRH 21 CFR 1040.10 and 1040.11 except for conformance
with IEC 60825-1 Ed. 3, as described in Laser Notice No. 56, dated
May 08, 2019.
Medical device
Mass of device
Tip over: Do not lean against the device. It may tip over.
Strong magnetic field
Type BF applied part
IPXX
Ingress Protection Rating
• Protection against foreign solids (numbers 0 to 6, or letter X).
• Protection against foreign liquids (numbers 0 to 9, or letter X).
NOTE: The letter X is listed if insufficient data has been gathered to assign a protec-
tion level.
WEEE (Waste Electrical and Electronic Equipment)
Potential Equalization
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Symbols on Packaging
Symbol Explanation
Handle with care
Do not stack
This side up
Keep dry
Temperature limit
NOTE: Indicates the temperature limits to which the medical device can be safely
exposed.
Humidity limitation
NOTE: Indicates the range of humidity to which the medical device can be safely ex-
posed.
Atmospheric pressure limitation
NOTE: Indicates the range of atmospheric pressure to which the medical device can
be safely exposed.
Caution
NOTE: User should consult the instructions for use for important cautionary informa-
tion such as warnings and precautions that cannot, for a variety of reasons, be pre-
sented on the medical device itself.
Symbols
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1.4 Using the System
Abbreviated Device Description
The device is the hardware hosting Brainlab IGS Software Applications. It is a composition of
display, computer, mechanical parts and a tracking device.
Intended Purpose
The device enables image guided surgery.
Intended Use and Indications for Use
Kick 2 Navigation Station is a hardware device used for surgery. The hardware hosts one or
more Brainlab Software Applications. It incorporates a computer and display unit to facilitate the
display, exchange, processing and interaction with data and tracking for Imaged Guided Surgery
(IGS) purposes.
The indications for use depend on the application software. For details please refer to the
respective application software documentation.
Clinical Benefit
The indirect clinical benefit of the device is that it provides the necessary platform to enable a safe
and effective Brainlab use case, which can only be performed in combination with a Brainlab IGS
Platform.
Known Contraindications
The use of the EM Tracking system within 200 mm of an active implantable or body worn medical
device (e.g., ICDs, neurostimulators, cochlear implants) is contraindicated. According to the
warning stated in this user guide, an installed active implantable or body worn medical device
cannot be within 200 mm of an operating EM field generator, since the magnetic field produced by
the EM filed generator may interfere with the active implantable or body worn medical device. Not
following this rule comprises a contradiction for using EM Tracking in a patient with an active
implantable or body worn medical device as the safety of this patient cannot be guaranteed
anymore.
Place of Use
The device is intended to be used in professional healthcare facility environment. The device is
placed inside the patient environment.
Installation and Configuration
Device installation and configuration must be performed by Brainlab trained service personnel.
Please contact Brainlab support for assistance in backing up the system configuration.
User Profiles
User Supposed Roles
Clinical Team Physician
Nurse
Cleaner Nurse
OR assistant
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User Supposed Roles
Medical Technician Trained Brainlab employees
Brainlab trained service personnel
Recurrent Test Requirements
Inspections by Non-Brainlab Personnel
Only trained and skilled personnel (in the following named as "medical technician") are allowed to
perform electrical safety tests.
The test must be performed by a qualified engineer who:
• Is qualified to carry out safety inspections on electrical medical equipment.
• Is familiar with the product safety information and product instructions, and has read and
understood the user guides.
• Is up-to-date with current local regulations regarding industrial and non-industrial accident
prevention.
• Informs Brainlab immediately in writing if the equipment is deemed unsafe.
• Places system out of operation and marks it as such.
Use Environment
The system is only for use indoors, in a hospital operating room under the following environmental
conditions:
Specification Operating Conditions
Temperature 10 °C (50 °F) to 30 °C (86 °F)
Humidity 30% to 75% non-condensing
Altitude/Pressure The device can be operated up to 3,000 m above sea level.
NOTE: This equals a range from 700 hPa to 1060 hPa air pressure.
Patient Population
The patient population depends on the application software. For details please refer to the
respective application software documentation.
Expected Service Life
The Monitor Cart and Camera Cart provides an expected service life of eight years. The EM
Tracking Unit provides an expected service life of five years.
Careful Handling of Hardware
The device is a highly sensitive medical device. Handle it with care.
Using the System
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1.5 Software Environment
Bill of Materials of Integrated Third-Party Software
Monitor Cart
• Windows 10 IoT 2019 LTSC (including .NET framework 4.7)
• Intel Management Engine Driver - 1937.12.0.1312
• Realtek High Definition Audio Driver 6.0.8683.1
• NVidia Quadro Driver - 441.12
• Fujitsu Device Driver - 3.0.0.3
• Intel LAN Driver - 12.18.9.1
• Intel LAN Driver - 12.18.9.10
• Intel Chipset Device Driver - 10.1.18019.8144
• Realtek WLAN Driver netrtwlanu.inf 1030.25.0701
• Yuan CODEC Pack Mini 1.1.0.189
• Yuan SC550 (MZ0380) Driver 1.1.0.189
• ESD CAN Device Driver - 6.0.2604.0
• FTDI CDM Driver - 2.12.28
• Edimax Wireless 7822ULC Driver - 1.0.1.6
Changes or updated information can be found on our website.
IT Security Controls Included in the Medical Device
Monitor Cart:
• User authentication is required
• User Account Control is active
• Firewall is enabled – incoming traffic blocked, exceptions defined
• Anti-malware software is active
• Netbios is disabled
• Autorun for removable devices is disabled
• Security audit log is enabled
• Unnecessary components are disabled
• Telemetry is disabled
• All the following Group Policies in the path "Computer / Policies / Administrative Templates"
must not be changed:
- Control Panel/Personalization
- Control Panel/User Accounts
- System/Device Installation
- System/Logon
- System/Internet Communication Management
- System/Power Management
- System/Shutdown
- Windows Components/AutoPlay Policies
- Windows Components/Desktop Window Manager
- Windows Components/Event Log Service
- Windows Components/Internet Explorer/Security Features/Add-on Management
- Windows Components/Windows Defender/Exclusions
- Windows Components/Windows Update
Common Firewall Settings
To enhance system security the Windows Firewall is enabled on Kick Monitor Cart for all profiles:
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• Inbound connections that do not match a rule are blocked for Domain, Private and Public
firewall profiles.
• Outbound connections that do not match a rule are allowed for Domain, Private and Public
firewall profiles.
This is the default behavior of the Windows version provided – no additional configuration steps
are required. For a list of inbound rules, see the Appendix.
The following rule is enabled:
• ICMP Echo request for both IPv4 and IPv6 is enabled for troubleshooting.
The following rules are disabled:
• Cortana
• Delivery Optimization (TCP-In)
• Delivery Optimization (UDP-In)
• Wireless Display Infrastructure Back Channel (TCP-In)
Log File Management
Log files, used for forensic analysis, are stored on the local file system. These log files are
deleted/archived as part of maintenance activities. Access control is activated for the log files. The
log files are not recycled. The log files are structured and allow parsing by an automated process
(e.g., for IDS).
Updates
Security updates must be installed outside clinical hours.
Modification
Do not download or install updates during patient treatment or treatment planning. Do not modify
the software configuration unless instructed to.
Passwords
Contact Brainlab support for assistance in dealing with a stolen or forgotten password. The
system comes with a default administrative password for Brainlab trained service personnel. To
change this password, contact Brainlab support.
Storage of Patient Data
The system is not intended for storage of patient data. However, patient data is temporarily stored
unencrypted locally on the device. If you want the data to be removed from the device, please
contact Brainlab support. If the device needs to be shipped to Brainlab for repairs, delete patient
data or the mass storage media will be removed by Brainlab support and returned.
Virus Scanning and Malware
Brainlab recommends protecting the system with state-of-the-art antivirus software. System
performance must be verified by a Brainlab service engineer after the first antivirus software
installation. Be aware that some malware protection software (e.g., virus scanner) settings can
negatively affect system performance. For example, if real-time scans are performed and each file
access is monitored, then access to patient data may be restricted. For best results:
• Disable any extra antivirus software features (e.g., browser or email-scanners, additional
firewall).
• Disable antivirus software pop-up messages.
Configure antivirus software (e.g., by adding to folder exceptions) so that it does not scan or
modify the following:
• C:\Brainlab, F:\Brainlab
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• C:\PatientData, F:\PatientData
Contact Brainlab support for further information regarding any of these issues.
Microsoft Security Updates for Windows
To install Windows security updates a user must be a member of the group Administrators.
Brainlab allows the installation of security patches only. Do not install service packs and optional
updates. Verify your settings to ensure updates are downloaded and installed correctly and at a
suitable time. Do not update drivers with Windows Update.
Brainlab trained service personnel will install security updates and anti-virus definition updates as
part of the preventive maintenance inspections and during repair actions.
Blocked Updates
See the Brainlab website for more information about settings and a list of Microsoft Security
Updates blocked by Brainlab support.
Address: www.brainlab.com/updates
Password: WindowsUpdates!89
Leaflets
Guide Contents
IEC 80001 Summary Leaflet containing information for the medical
IT network risk manager.
Antivirus and Windows Update Leaflet containing the latest information from
Brainlab on anti-virus and Windows updates.
Related Links
Firewall Settings on page 127
Emergency Access to the Platform
NOTE: Perform this configuration action only if requested by the customer. It should be left
unchanged otherwise.
To create an additional user account for emergency access to the system:
Step
1. Switch on the system and login as Administrator.
2. Open Computer Management by typing the name in Search under the Windows Start
Menu.
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Step
3. Right click on the empty space inside the window and choose New User… from the
menu.
4. Enter the user name (does not have to match the screenshot below) and ensure all the
checkboxes are unchecked.
Enter a password and confirm the password.
5. Click Create.
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Step
6. Double click on the newly created user to open Properties.
In Properties, select the second tab Member Of, and add the iHelpManagers group by
following the order presented below:
How to Configure a Standard User Account
Add user to the group (as described above).
An Administrator must have a password.
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How to Configure the Inactivity Timeout
The screen locks if the user has been inactive for some time. In the default configuration, no
inactivity timeout has been set. To set the timeout:
Step
1. Right-click in the display and select Personalize.
2. Select Lock Screen.
3. Select Screen Saver Settings.
4. Set the timeout before the screen saver activates in minutes in Wait.
5. Activate On resume, display logon screen.
Automatic Driver Update
Do not update drivers on Brainlab platforms either manually or by using Windows update
functionality.
Network Safety
Connecting Kick 2 Navigation Station to an IT-Network that includes other equipment could
result in previously unidentified risks to patients, operators or third parties. You must identify,
analyze, evaluate and control the risks that may occur when connecting Kick 2 Navigation
Station to a network or data coupling where other equipment is connected.
Making changes to the network/data coupling could introduce new risks that require additional
analysis. These changes may include, but are not limited to:
• Changes in configuration
• Connection or disconnection of additional equipment
• Update or upgrade of connected equipment
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