Brainlab Buzz 2.0 User manual

BUZZ
Version 2.0
System and Technical User Guide
Revision 1.2
Date of issue: 2020-05-18 (ISO 8601)
Copyright 2020, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS
1 GENERAL INFORMATION.............................................................................................5
1.1 Contact Data........................................................................................................................................5
1.2 Legal Information ...............................................................................................................................6
1.3 Symbols................................................................................................................................................8
1.3.1 Symbols Used in This Guide...............................................................................................................8
1.4 Using the System .............................................................................................................................11
1.5 Software Environment.....................................................................................................................13
1.6 Training and Documentation..........................................................................................................19
2 SYSTEM OVERVIEW........................................................................................................21
2.1 System Components .......................................................................................................................21
2.1.1 Overview...........................................................................................................................................21
2.1.2 Ventilation ........................................................................................................................................25
2.2 OR Setup............................................................................................................................................27
2.3 Proper System Handling.................................................................................................................30
2.4 Using the System .............................................................................................................................32
2.4.1 Turning Buzz On and Off...................................................................................................................32
2.4.2 System Messages............................................................................................................................34
2.4.3 Touch Display Interaction .................................................................................................................36
2.5 System Connections........................................................................................................................37
2.5.1 Overview...........................................................................................................................................37
2.5.2 Third-Party Connections...................................................................................................................39
2.5.3 Potential Equalization Connection....................................................................................................45
3 CLEANING AND DISINFECTION...........................................................................47
3.1 Cleaning Instructions ......................................................................................................................47
3.1.1 Overview...........................................................................................................................................47
3.1.2 Instructions.......................................................................................................................................48
4 COMPLIANCES AND SPECIFICATIONS.......................................................49
4.1 Standards...........................................................................................................................................49
4.2 Environmental Requirements........................................................................................................50
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4.2.1 Environmental Conditions .................................................................................................................50
4.3 System Specifications.....................................................................................................................51
4.3.1 Physical Characteristics....................................................................................................................51
4.3.2 Technical Specifications ...................................................................................................................53
4.3.3 Hospital Network..............................................................................................................................54
4.4 Compliances......................................................................................................................................56
4.4.1 Electromagnetic Emissions ...............................................................................................................56
4.4.2 General Electromagnetic Immunity...................................................................................................57
4.4.3 RF Communication Equipment.........................................................................................................59
4.4.4 Tested Cables ..................................................................................................................................60
4.4.5 Supported Resolutions.....................................................................................................................62
5 ELECTRICAL SAFETY....................................................................................................65
5.1 Introduction .......................................................................................................................................65
5.1.1 Buzz System.....................................................................................................................................65
5.2 Test Requirements ...........................................................................................................................66
5.2.1 Overview...........................................................................................................................................66
5.2.2 Testing Overview..............................................................................................................................67
5.2.3 Recurrent Tests................................................................................................................................68
5.3 Performing Tests ..............................................................................................................................71
5.3.1 Protective Earth Resistance..............................................................................................................71
5.3.2 Equipment Leakage Current.............................................................................................................72
5.3.3 Touch Current...................................................................................................................................74
6 MAINTENANCE......................................................................................................................77
6.1 Inspections ........................................................................................................................................77
6.1.1 Overview...........................................................................................................................................77
6.1.2 Annual Inspection.............................................................................................................................78
6.1.3 Safety Inspection..............................................................................................................................79
6.1.4 Safety Inspection Measurements .....................................................................................................80
6.2 Malfunctions and Return Instructions.........................................................................................81
6.2.1 Malfunctions......................................................................................................................................81
6.2.2 Return Instructions...........................................................................................................................82
TABLE OF CONTENTS
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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]
Service Life
Brainlab provides eight years of service for platforms. During this period of time, spare parts as
well as field support are offered.
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
System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0 5

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
BuzzTM is a trademark of Brainlab AG.
Brainlab®is a trademark of Brainlab AG.
Non-Brainlab Trademarks
• Intel® is a registered trademark of Intel Corporation in the US and other countries.
• Microsoft® and Windows® are registered trademarks of Microsoft Corporation in the US and
other countries.
• Fujitsu is a trademark of Fujitsu Ltd.
• Barco is a trademark of Barco N.V.
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”).
Buzz is a Class I product according to the rules established by the MDR.
NOTE: The validity of the CE label can only be confirmed for products manufac-
tured by Brainlab.
Placing Buzz Out of Operation
Please contact Brainlab support when placing Buzz out of operation.
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
Perchlorate
For residents of the state of California, U.S.A., special handling may apply to perchlorate
materials. For more information, visit: www.dtsc.ca.gov/hazardouswaste/perchlorate.
Legal Information
6 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0

For recycling instructions, please contact Brainlab.
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
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.
FCC Compliance
Buzz has been tested and found to comply with the limits for a Class A digital device, according 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 instructions, 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 personal
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.
GENERAL INFORMATION
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1.3 Symbols
1.3.1 Symbols Used in This Guide
Warnings
Warning
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.
Symbols on Hardware Components
The below symbols may be found on the system.
Symbol Explanation
Caution
Potential equalization point
Do not use if packaging is damaged
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
Symbols
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Symbol Explanation
Quantity of products in packaging
Batch number
Serial number
Article number
Date of manufacture
Manufacturer
ETL/Intertek approval
Radio device
Risk of electrical shock
Class I Laser: Risk of injury due to laser radiation
Power button
Consult the operating instructions
Follow the instructions for use
U.S. federal law restricts this device to sale by or on order of a physician.
Medical Device
Unique Device Identifier
GENERAL INFORMATION
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Symbol Explanation
Handle with care
This side up
Do not stack more than n
Contains renewable materials
Symbols
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1.4 Using the System
Intended Use and Indications for Use/Intended Purpose
Buzz 2.0 is intended for use as a stationary computing platform hosting one or more software
applications. Buzz 2.0 facilitates the display and exchange of, as well as the interaction with data.
Buzz 2.0 also offers interaction with external/additional devices or components within the defined
performance specification while used in the intended use environment.
The intended medical indication depends on the application software running on the device. For
details please refer to the respective system documentation.
Place of Use
The system is only for use indoors, in a professional healthcare environment.
Frequency of Use
The frequency of use is defined to be between once per week and several times per day.
User Profile
The following lists the intended user profiles, differentiated by their interaction with the device
based on their role.
Clinical Team:
• Non-sterile preparation and set-up prior to use
• Non-sterile usage of videos, images and data
• Shut down and tidying of equipment after surgery
A more detailed user profile for the clinical team may depend on the application software running
on the platform incorporating the Wall Display. For details please refer to the respective system
documentation.
Cleaner:
• Cleaning of switched off device
Medical Technician:
• Maintenance
• Oversee electrical safety of device during service life
• Disposal of the device after service life
Patient Population
The intended patient population is not limited to a specific patient group. There are no
demographic limitations for patients.
Essential Performance
The device has no clinical functions, especially no functions where loss or degradation lead to a
risk beyond basic safety aspects. Therefore the device has no essential performance
characteristics.
Clinical Benefit
Buzz does not have any clinical benefits nor clinical performance. In combination with the
software applications running on Buzz, it supports the clinical performance of these software
applications.
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Known Contraindications
Buzz does not have a direct therapeutic impact and hence no side effects or contraindications are
aligned with its use.
Careful Hardware Handling
Only trained users are allowed to use Buzz.
Plausibility Review
Warning
Before patient treatment, review the plausibility of all information input to and output from
the device.
Diagnostic Imaging
Warning
The system has not been tested for diagnostic image quality and may not provide
sufficient image quality or resolution. The touch display does not comply with DIN EN6868
and is therefore not intended for the transmission or display of diagnostic images.
Using the System
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1.5 Software Environment
Bill of Materials of Integrated Third-Party Software
Buzz 2.0 Computer (Article Number 15835A):
• Windows 10 IoT Enterprise 2016 LTSB
• Chipset driver - SPSR 10.1.2.10
• FUJ02E3 driver - 1.30.3.0
• Rapid Storage driver - RST SATA sSATA 4.3.0.1198
• LAN Install Pack - Intel 12.12.226.0
• ME Driver - Intel Management Engine 11.0.0.1157
• Nvidia Driver - 10.18.13.6191
• Realtek-audio - 6.0.1.7606
• Matrox Drivers – Orion 10.11.1222.0
• Matrox Drivers – Morphis 10.0.2564.0
• FTDI driver - 2.12.28.0
• ESD-CAN - 6.0.2604.0
Digital OR Computer For Barco Integration (Article Number 15410)
• Windows 10 IoT Enterprise 2016 LTSB
• Chipset driver - SPSR 10.1.2.10
• FUJ02E3 driver - 2.0.1.0
• Rapid Storage driver - RST SATA sSATA 4.5.4.1030
• LAN Install Pack - Intel 12.15.23.7
• ME Driver - Intel Management Engine 11.6.0.1042
• Nvidia Driver - 22.21.13.8541
• Realtek-audio - 6.0.1.8192
• Barco Drivers - FrGrabber 7.51.32.633
• Barco Drivers - NIC 7.51.40.664
• FTDI driver - 2.12.16.0
• ESD-CAN - 6.1.2609.0
IT Security Controls Included in the Medical Device
Buzz:
• 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
• 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
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- 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
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
• C:\PatientData, F:\PatientData
Contact Brainlab support for further information regarding any of these issues.
Microsoft Security Updates for Windows
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.
Software Environment
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Address: www.brainlab.com/updates
Password: WindowsUpdates!89
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.
3. Right click on the empty space inside the window and choose New User… from the
menu.
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Step
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.
Software Environment
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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
To install Windows security updates a user must be a member of the group Administrators.
Add user to the group (as described above).
An Administrator must have a password.
Automatic Driver Update
Do not update drivers on Brainlab platforms either manually or by using Windows update
functionality.
GENERAL INFORMATION
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Cybersecurity Use Environment
Cybersecurity considerations were made in accordance with the nature of the device, including
the device type and the following use environments of the platform(s) during its lifetime. The
following common best practice security controls (“security hygiene”) in the use environment are
expected to be followed. Independently of the status of the platform (powered / not-powered):
• Good physical security to prevent unauthorized physical access to the platform.
If the platform is powered on, the following additional security controls are expected to be
followed:
• Access control measures (e.g., role based) to ensure only authenticated and authorized
personnel are allowed access to network elements, stored information, services and
applications.
• Network access controls, such as segmentation, to limit medical device communication.
• General patch management practices that ensure timely security patch updates on adjacent
devices in the use environment. For the patch management of the platform, see the information
under Software Environment in this user guide.
• Malware protection to prevent unauthorized code execution on adjacent devices in the use
environment. For the malware protection of the platform, see the information under Software
Environment in this user guide.
• Ensure that prescribed maintenance is done as required, including installation of security
patches.
• Security awareness training of the users.
Using the device outside of the intended operating environment may lead to cybersecurity
incidents that may affect safety and effectiveness of the device
Software Environment
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1.6 Training and Documentation
Brainlab Training
Before using the system, all users must participate in a mandatory training program held by a
Brainlab authorized representative to ensure safe and appropriate use.
Responsibility
Warning
This system solely provides assistance to the surgeon and does not substitute or replace
the surgeon's experience and/or responsibility during its use. It must always be possible
for the user to proceed without the assistance of the system.
Only trained medical personnel may operate system components and accessory instrumentation.
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.
Intended Audience
This user guide is intended for doctors 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 Detailed software instructions
System and Technical
User Guide
• Comprehensive information on system setup and use
• Detailed technical information on the system, including specifica-
tions and compliances
Site Planning Manual Detailed instructions for the effective and correct implementation of
Buzz.
NOTE: Available user guides vary depending on the Brainlab product. If you have questions
regarding the user guides you received, contact Brainlab support.
GENERAL INFORMATION
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Training and Documentation
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