Brainlab Buzz 2.0 Bedienungsanleitung
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
TABLE OF CONTENTS
System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0 3
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
4 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0
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: +1 800 597 5911
UK Tel: +44 1223 755 333
Spain Tel: +34 900 649 115
France and French-speaking
regions Tel: +33 800 676 030
Africa, Asia, Australia, Europe Tel: +49 89 991568 1044
Fax: +49 89 991568 5811
Japan Tel: +81 3 3769 6900
Fax: +81 3 3769 6901
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
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
System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0 7
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
8 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0
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
System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0 9
Symbol Explanation
Handle with care
This side up
Do not stack more than n
Contains renewable materials
Symbols
10 System and Technical User Guide Rev. 1.2 Buzz Ver. 2.0
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