Brainlab Buzz Navigation User manual

BUZZ
NAVIGATION
(CEILING-
MOUNTED)
Version 1.0
System and Technical User Guide
Revision 1.2
Date of issue: 2020-05-25 (ISO 8601)
Copyright 2020, 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
1.3.1 Symbols Used in This Guide.............................................................................................................10
1.4 Using the System .............................................................................................................................13
1.5 Compatibility with Medical Devices .............................................................................................15
1.6 Training and Documentation..........................................................................................................16
2 SYSTEM OVERVIEW........................................................................................................19
2.1 System Components .......................................................................................................................19
2.2 Displays..............................................................................................................................................22
2.2.1 42" Display.......................................................................................................................................23
2.2.2 CM Display/Additional CM Display...................................................................................................24
2.3 CM Camera.........................................................................................................................................25
2.4 Medical Computer Unit (MCU).......................................................................................................29
2.4.1 Overview...........................................................................................................................................29
2.4.2 MCU Connections............................................................................................................................30
2.4.3 Third-Party Connections...................................................................................................................32
2.4.4 Wireless LAN Connection ................................................................................................................34
2.4.5 MCU Ports .......................................................................................................................................36
2.4.6 Potential Equalization Connection....................................................................................................39
2.5 Connection Unit................................................................................................................................40
2.6 OR Setup............................................................................................................................................42
2.6.2 Configuration....................................................................................................................................44
2.6.3 Ventilation ........................................................................................................................................46
2.7 Proper System Handling.................................................................................................................47
2.8 Using the System .............................................................................................................................48
2.8.1 Switches............................................................................................................................................48
2.8.2 System Messages............................................................................................................................51
2.8.3 Display Interaction............................................................................................................................53
2.9 Sterile Use..........................................................................................................................................54
2.9.1 Sterile Camera Handle Drape ...........................................................................................................54
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2.9.2 Sterile Monitor Drape .......................................................................................................................56
2.10 Using in an MR Environment.......................................................................................................58
2.10.1 MRI Setup .....................................................................................................................................60
3 CLEANING AND DISINFECTION...........................................................................61
3.1 Cleaning Overview...........................................................................................................................61
4 COMPLIANCES AND SPECIFICATIONS.......................................................63
4.1 Standards...........................................................................................................................................63
4.2 Environmental Conditions..............................................................................................................65
4.3 Compliances......................................................................................................................................66
4.3.1 Electromagnetic Emissions ...............................................................................................................66
4.3.2 General Electromagnetic Immunity...................................................................................................67
4.3.3 RF Communication Equipment.........................................................................................................69
4.3.4 Tested Cables ..................................................................................................................................70
4.3.5 Supported Resolutions.....................................................................................................................72
4.4 Physical Specifications...................................................................................................................75
4.5 Technical Specifications.................................................................................................................76
4.6 Electrical Specifications .................................................................................................................77
4.7 Hospital Network..............................................................................................................................78
5 ELECTRICAL SAFETY....................................................................................................81
5.1 Introduction .......................................................................................................................................81
5.2 Test Requirements ...........................................................................................................................82
5.2.1 Overview...........................................................................................................................................82
5.2.2 Testing Overview..............................................................................................................................83
5.2.3 Recurrent Tests................................................................................................................................84
5.3 Performing Tests ..............................................................................................................................86
5.3.1 Protective Earth Resistance..............................................................................................................86
5.3.2 Equipment Leakage Current.............................................................................................................88
5.3.3 Touch Current...................................................................................................................................92
6 MAINTENANCE......................................................................................................................97
6.1 Inspections ........................................................................................................................................97
6.1.1 Overview...........................................................................................................................................97
6.1.2 Annual Inspection.............................................................................................................................98
6.1.3 Safety Inspection..............................................................................................................................99
6.1.4 Safety Inspection Measurements ...................................................................................................100
6.2 Malfunctions and Return Instructions.......................................................................................101
6.2.1 Malfunctions....................................................................................................................................101
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6.2.2 Return Instructions.........................................................................................................................102
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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
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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
•Buzz Navigation (Ceiling-Mounted)™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.
• Barco is a trademark of Barco NV.
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 re-
quirements of Council Directive 93/42/EEC (the “MDD”).
According to the principles set out in the MDD, Buzz Navigation (Ceiling-
Mounted) is a Class IIb product.
NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
Placing Buzz Navigation (Ceiling-Mounted) Out of Operation
Please contact Brainlab support when placing Buzz Navigation (Ceiling-Mounted) out of
operation.
Sales in US
US federal law restricts this device to sale by or on the order of a physician.
FCC Compliance
Buzz Navigation (Ceiling-Mounted) 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.
Legal Information
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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.
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
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.
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 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
Type B Applied Part according to IEC 60601-1
Type BF Applied Part according to IEC 60601-1
Caution
Potential equalization point
Do not reuse
Non-Sterile
Do not resterilize
Symbols
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Symbol Explanation
Sterilized with ethylene oxide
Do not use if packaging is damaged
Keep away from sunlight
Keep dry
Storage conditions for temperature: The specified temperature range is shown on
each label
Storage conditions for relative humidity non-condensing: The specified humidity
range is shown on each label.
Storage conditions for air pressure: The specified air pressure range is shown on
each label
Quantity of products in packaging
Batch number
Serial number
Article number
Use by month YYYY
Date of manufacture
Manufacturer
Authorized representative in the European Community
MR Conditional
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Symbol Explanation
ETL/Intertek approval
Radio device
Risk of electrical shock
Class I Laser: Risk of injury due to laser radiation
(Vega Camera)
Laser radiation emitted from aperture
Do not stare into beam
Class 2 laser product
max. output 1mW wavelength 635-670 nm
ANSI Z136.1 (2014), IEC 60825-1 (2014)
FDA/CDRH 21 CFR 1040.10 and 1040.11 except for deviations pursuant to
Laser Notice No. 50, dated June 24, 2007.
IPXX
Ingress Protection according to IEC 60529
• X = Protection against ingress of solid objects
• Y = Protection against ingress of liquid
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.
Unique device identification
Symbols
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1.4 Using the System
Intended Use
The Buzz Navigation (Ceiling-Mounted) is a stationary navigation platform used for Image
Guided Surgery (IGS) incorporating an optical tracking system. The computing platform hosts one
or more software applications and facilitates the display and exchange of, as well as the
interaction with data. The Buzz Navigation (Ceiling-Mounted) also offers interaction with
external/additional devices or components within the defined performance specification while used
in the intended use environment.
Place of Use
The system is only for use indoors, in a professional healthcare environment.
Warning
Buzz Navigation (Ceiling-Mounted) has not been tested in HF Surgery environment.
User Profiles
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 handling of ME device during surgery (e.g., re-positioning of camera)
• Sterile or non-sterile interaction with videos, images and data
• Shut down, tidying and storage of equipment after surgery
A more detailed user profile for the clinical team may depend on the application software running
on the device. For details please refer to the respective documentation of the application that will
run on the platform.
Cleaner:
• Cleaning of switched off device
Medical Technician:
• Brainlab trained service personnel:
- Installation of device including unpacking and transportation of device to its destination
- Training of users on device
- Troubleshooting and repair of device
• Maintenance
• Oversee electrical safety of device during service life
• Disposal of the device after service life
Patient Population
The intended patient population consists of patients that could be treated using Brainlab software
released for the Buzz Navigation (Ceiling-Mounted). For details refer to the relevant Software
User Guide.
Careful Handling of Hardware
System components and accessory instrumentation are comprised of precise mechanical
parts. Handle them carefully.
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Plausibility Review
Warning
Before patient treatment, review the plausibility of all information input to and output from
the system.
Careful Hardware Handling
Only trained users are allowed to use Buzz Navigation (Ceiling-Mounted).
Using the System
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1.5 Compatibility with Medical Devices
Brainlab Medical Devices
The Buzz Navigation (Ceiling-Mounted) is compatible with
•Sterile Camera Handle Drape
•Monitor Drape
The CM Camera Joint is compatible with the Sterile Drape Camera Handle.
Only connect equipment specified by Brainlab or which Brainlab has stated to be compatible with
Buzz Navigation (Ceiling-Mounted).
Only use marker spheres and active Brainlab technology released for use with the NDI
Polaris Vega.
Other Brainlab Instruments
Additional instrumentation may become available after release of this user guide. Contact Brainlab
support if you have any questions regarding compatibility.
Warning
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 the safety of the patient, user and/or environment.
Non-Brainlab Devices
Warning
Using medical device combinations that have not been authorized by Brainlab may
adversely affect safety and/or effectiveness of the devices and endanger the safety of the
patient, user and/or 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.
Installation
The system is installed by qualified Brainlab representatives.
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.
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.
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, typi-
cally defined as large complex instruments
Instrument User Guides Detailed instructions on instrument handling
Training and Documentation
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User Guide Contents
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 specifica-
tions and compliances
System and Technical User
Guide Combines the contents of the System User Guide and the Techni- cal User Guide.
Ceiling Arm
The ceiling arm system is a third party product and not provided by Brainlab. Please refer
to the third-party manual regarding risks occurring from that device.
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Training and Documentation
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2 SYSTEM OVERVIEW
2.1 System Components
General Information
Buzz Navigation (Ceiling-Mounted) can be used in a professional healthcare facility
environment for various surgical procedures involving video processing, image recording, patient
data viewing and software application control. It is suitable for continuous use during surgical
procedures.
Integrating the ceiling-mounted camera and display, and using suitable application software, Buzz
Navigation (Ceiling-Mounted) is used as navigation station.
Frequently Used Functions
The following are defined as the most frequently used Buzz Navigation (Ceiling-Mounted)
hardware functions:
• Positioning prior to surgery
• Activation of laser pointer for positioning
• Start up/shutdown
• Non-sterile repositioning of ceiling-mounted components during surgery
• Sterile use of ceiling-mounted components during surgery
• Cleaning of switched-off device
• Connecting/unplugging third-party devices
• Transferring patient data to the device
• Sterile and unsterile interacting with application software
Buzz Navigation (Ceiling-Mounted) Components
Buzz Navigation (Ceiling-Mounted) (article number 15706) comprises the following
components:
Component Description
Medical Computer Unit
(MCU)
Processes data that can be displayed on a connected display or pro-
vided at interface connections at the MCU user or connection panel,
Feature Panel or Connection Unit.
42" Display Provides interaction with Brainlab software. Available as In- or On-
Wall variant.
Ceiling-mounted (CM)
Display
Display unit to display the navigation, including touch functionality for
user to interact with the software. This is the main display for image-
guided surgery.
Ceiling-mounted (CM)
Camera An optical tracking system (camera on a camera joint).
SYSTEM OVERVIEW
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Component Description
Connection Unit
An optional device used for extending the interfaces available on the
MCU. As the MCU is located outside the OR, the Connection Unit is
necessary, (e.g., for connection of third-party devices such as the mi-
croscope, ultrasound, or c-arm that are available inside the OR). The
Connection Unit provides interfaces for data, video input and video
output.
Supply Unit Provides electric power (DC) to the CM Display and CM Camera. It also converts optical fiber Ethernet connection from the MCU to cop-
per-based Ethernet connection to the CM Camera.
Feature Panel Enables monitoring, control and interaction with the MCU.
Warning
Do not place objects on Buzz Navigation (Ceiling-Mounted) components.
Illustration
⑤
②
①
③
④
No. Description
①Additional (optional) 42" Display
②42" Display
③
CM Display
NOTE: An additional (optional) CM Display is possible instead of Additional 42" Dis-
play.
④CM Camera
⑤Connection Unit
Related Links
Medical Computer Unit (MCU) on page 29
System Components
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