Brainlab 17902 User manual

WALL
TOUCH SCREEN
Ref-No. 17902
System and Technical User Guide
Revision 1.0
Date of issue: 2023-06-28 (ISO 8601)
Copyright 2023, 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
1.4 Using the System .............................................................................................................................11
1.5 Compatibility with Medical Devices .............................................................................................13
1.6 Training and Documentation..........................................................................................................14
2 SYSTEM COMPONENTS..............................................................................................15
2.1 System Components .......................................................................................................................15
2.2 System Setup ....................................................................................................................................17
2.3 System Use........................................................................................................................................18
2.4 Proper System Handling.................................................................................................................19
2.5 Use in an MR Environment.............................................................................................................20
2.6 Type Plate...........................................................................................................................................21
3 CLEANING..................................................................................................................................23
3.1 Preparing for Cleaning....................................................................................................................23
3.2 Cleaning the Wall Touch Screen...................................................................................................24
4 ELECTRICAL SAFETY INSPECTION................................................................25
4.1 Electrical Safety Inspection Background....................................................................................25
4.2 Test Precautions...............................................................................................................................27
4.2.1 Test Overview....................................................................................................................................27
4.2.2 Test Steps ........................................................................................................................................28
4.3 Recurrent Test...................................................................................................................................29
4.3.1 Inspection Tasks................................................................................................................................29
4.3.2 Measuring Protective Earth Resistance............................................................................................31
4.3.3 Measuring Equipment Leakage Current...........................................................................................32
4.4 Recurrent Test for Medical Electrical Systems..........................................................................33
TABLE OF CONTENTS
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4.4.1 Overview...........................................................................................................................................33
4.4.2 Measuring Touch Current.................................................................................................................34
5 MAINTENANCE......................................................................................................................35
5.1 Maintenance Overview....................................................................................................................35
5.2 Maintenance Procedures................................................................................................................37
5.3 Malfunctions......................................................................................................................................40
5.4 Return Instructions..........................................................................................................................41
6 COMPLIANCES AND SPECIFICATIONS.......................................................43
6.1 Standards...........................................................................................................................................43
6.2 Physical Specifications...................................................................................................................44
6.3 Technical Specifications.................................................................................................................45
6.4 Environmental Requirements........................................................................................................46
6.5 Compliances......................................................................................................................................47
6.5.1 Electromagnetic Emissions ...............................................................................................................47
6.5.2 Electromagnetic Immunity................................................................................................................48
6.5.3 RF Communications Equipment ......................................................................................................50
6.5.4 Tested Cables and Accessories .......................................................................................................51
6.5.5 Supported Resolutions.....................................................................................................................52
INDEX....................................................................................................................................................53
TABLE OF CONTENTS
4 System and Technical User Guide Rev. 1.0 Wall Touch Screen Ref-No. 17902

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.
Non-Brainlab Trademarks
•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”).
Wall Touch Screen is a Class I product according to the rules established 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/weee/
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.
Environmental Impact
As a manufacturer, Brainlab complies with ISO 14001.
To do so, Brainlab supports customers in minimizing the environmental impact of all Brainlab
medical equipment during its expected service life and offers guidelines for proper end-of-life
management.
Legal Information
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Registration, Evaluation and Authorization of Chemicals (REACH)
REACH is the European chemicals law that came into force to improve the protection of human
health and the environment from risks that can be posed by chemicals. The identification of a
substance as a substance of very high concern and its inclusion in the candidate list for REACH
creates certain legal obligations for the importers, producers and suppliers of an article that
contains such a substance. Brainlab requests suppliers to inform whether and to what extent
substances from the list are used in their products. For further information regarding REACH
processes at Brainlab, contact us here:
www.brainlab.com/reach/
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.
GENERAL INFORMATION
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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.
Product Symbols
Symbol Explanation
Unique Device Identifier
Medical Device
Quantity of included items
Manufacturer's serial number
Reference (article) number
NOTE: Indicates the Brainlab product number.
Swiss authorized representative
Date of manufacture
NOTE: The date is expressed as in ISO 8601 as YYYY-MM-DD.
Manufacturer
Keep dry
Symbols
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Symbol Explanation
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.
Separate collection for EEE
Recyclable
Consult instructions for use
Follow instructions for use
U.S. federal law restricts this device to sale by or on order of a physician
MR conditional
NOTE: Presents no known hazards in a specific MR environment.
Fragile, handle with care
Do not stack
This side up
Recyclable
GENERAL INFORMATION
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Symbol Explanation
Cardboard recycling indicator
(German)
Temperature limit
NOTE: Indicates the temperature limits to which the medical device can be safely
exposed.
Keep dry
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.
Tested by SGS
Ground Terminals
Brainlab logo
DP DisplayPort interface
USB USB interface
IEC (C14) C14 socket
Brazilian label for electrical safety
China RoHs
Symbols
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1.4 Using the System
Abbreviated Device Description
The device is a 4K UHD multi-touch display with a screen diagonal of 55", including frames for on-
and in-wall mounting in professional healthcare facilities. The device can be connected to other
(medical) devices to display video signals (e.g., via DisplayPort) from the connected device and to
transfer manual touch input signals (e.g., via USB) to the connected device.
Intended Purpose
The device supports the visualization of video data and the interaction with software applications.
Intended Use and Indications for Use
The device supports the visualization of video data and the interaction with software applications.
The device does not have any specific indications.
Contraindications/Side Effects/Complications
The device does not have a direct therapeutic impact and hence no side effects or
contraindications are aligned with its use.
Residual Risks
Residual Risks include all risks remaining after the application of risk controls. For the Wall Touch
Screen a total number of 37 risks have been identified and evaluated during development.
With implemented risk control measures all risks have been mitigated to an acceptable level.
There are no simultaneous independent faults nor potential combination of risks, which could
result in an unacceptable hazardous situation or hazard.
Intended Patient Population
The intended patient population is not limited to a specific patient group. There are no
demographic limitations for patients.
Intended User Profile
User Supposed Roles
Clinical Team Physician
Nurse
Cleaner Nurse
OR assistant
Medical Technician Qualified customer personnel (e.g., hospital
technician)
Brainlab-trained employee
Brainlab Staff Brainlab-trained employee
Intended Use Environment
The device is intended to be used in Professional Healthcare Facility environments as defined by
IEC 60601-1- 2:2014.
GENERAL INFORMATION
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No components are allowed to be used in HF Surgical Equipment environment.
Specification Operating Conditions Storage Conditions Transport Conditions
Temperature 10°C (50°F) to 30°C
(86°F) -10°C (14°F) to 45°C (113°F) -10°C (14°F) to 45°C (113°F)
Humidity 30% to 75% non-con-
densing 10% to 90% non-con- densing 10% to 90% non-con- densing
Pressure The device can be operated up to 3,000 m above sea level.
700 hPa to 1060 hPa
The device is intended to be used in an MR Environment and marked after ASTM F2503-20.
The device shall be disconnected from mains power supply during MRI activities and shall be
installed outside the 0.50 mT field contour (5 Gauß volume).
Clinical Benefit
As standalone hardware, the device does not have any clinical benefits nor clinical performance.
In combination with Brainlab software applications displayed on the device, it supports the
performance of these software applications.
Expected Service Life
The device provides an expected service life of five years.
Careful Handling
The device is a highly sensitive medical device. Handle it with care.
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.
Using the System
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1.5 Compatibility with Medical Devices
Compatible Brainlab Medical Devices
The device can be connected to other (medical) devices to display video signals via DisplayPort
1.2 from the connected device and to transfer manual touch input signals via USB to the
connected device.
Compatible Non-Brainlab Medical Devices
The device can be connected to other (Medical) computing units with DisplayPort 1.2 interface
and, if interaction with the touch panel is desired, a USB interface.
GENERAL INFORMATION
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1.6 Training and Documentation
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 and Leaflets
Available user guides vary depending upon the Brainlab product. If you have questions regarding
the user guides you received, please contact Brainlab support.
Guide Contents
System and Technical User Guide Detailed information on system setup as well as technical information on the system, includ-
ing specifications and compliances
Leaflet Site planning and installation information: infor- mation and requirements for a installation of
the device in the OR environment.
Training and Documentation
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2 SYSTEM COMPONENTS
2.1 System Components
General Information
The system (Wall Touch Screen, 17902) is a 55" touch display that can display one or more
software applications. Possible uses include (but are not limited to) data management, image
viewing, planning or conferencing.
In order to do this, additional components required (e.g., computer, microphone, or speaker).
Wall Touch Screen
Figure 1
NOTE: The image depicts the on-wall option.
Mode of Operation
All system components are suitable for continuous use during surgical procedures.
SYSTEM COMPONENTS
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Frequently Used Functions
• Interacting with the touch panel
• Cleaning the device
Essential Performance
The device has no clinical functions, especially no function where loss or degradation leads to a
risk beyond basic safety aspects. Therefore the device has no essential performance
characteristics. The device may have an essential performance, when combined with a navigation
software application. Therefore, please refer to the device description of the respective navigation
software application.
Mounting Options
There are three mounting options for the Wall Touch Screen:
• On-Wall
• In-Wall (flush with the wall)
• In-Wall with decorative panel
System Components
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2.2 System Setup
General Information
When planning the OR setup, consider the position of system components so that the airflow is
not directed into the patient area.
Mains Power
Only use the power supply cord provided by Brainlab.
Ensure that the system is set up in a way that, in case of malfunction, you are able to quickly
disconnect mains power. This means that the appliance coupler or a main switch must be readily
accessible according to Brainlab specifications.
Externally installed mains switches belong to the electrical installation of the OR installation. The
external mains switches are marked accordingly. Requirements for an external mains switch:
• Recognizably belongs to the Wall Touch Screen.
• Conforms to IEC 61058-1 for a mains transient voltage of 4 kV.
• Disconnects phase and neutral simultaneously.
• Labeled according to IEC 60601-1:2005+A1:2012+A2:2020 Clause 7.4.1
• Suitable for the electrical specifications of component(s) connected to the switch.
• Installed in close vicinity to the Wall Touch Screen.
• Protective earth may not be separated by the switch.
Warning
To avoid the risk of electric shock, the Wall Touch Screen (Class 1) shall only be connected
to mains power equipped with protective earth in accordance with IEC
60601-1:2005+A1:2012+A2:2020 Clause 7.9.2.2.
Sterile Field
The device is non-sterile. Do not position any device components inside the patient environment
or sterile field.
Position
Wall Touch Screen users are expected to stand in front of the touch display within easy reaching
distance, in order to use their fingers to control the device.
When looking at the touch display, be aware that colors may be displayed incorrectly if viewed
from an inadequate angle.
The device can be flipped down 90° (Service Position) when maintenance/service is required.
Ensure that there is sufficient space in front of and below the system and no permanent objects
are installed there.
Only Connect Specified Equipment
Warning
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 62368-1 for data processing equipment and IEC
60601-1:2005+A1:2012+A2:2020 (Edition 3.2) for medical equipment). Furthermore, all
configurations shall comply with the requirements for medical electrical systems (see IEC
60601-1-1 or clause 16 of IEC 60601-1:2005+A1:2012+A2:2020 (Edition 3.2), respectively).
Anyone connecting additional equipment to the device configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical
systems. Please note that local laws take priority over the above-mentioned requirements.
In doubt, consult your local representative or the technical service department.
SYSTEM COMPONENTS
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2.3 System Use
Diagnostic Imaging
The device has not been tested for diagnostic image quality and may not provide sufficient
image quality or resolution. The touchscreen does not comply with DIN EN 6868 and is
therefore not intended for the transmission or display of diagnostic images.
How to Power Up the System
The Wall Touch Screen is always on when connected to mains. When no valid input signal is
detected on a video input interface, the device goes to stand-by mode. It will power up as soon as
a valid input signal is detected.
How to Shut the Device Down
Disconnect the Wall Touch Screen from mains to shut it down completely by removing the mains
power plug or using a separately installed mains switch.
Indicator LED
An indicator light provides information about the device status:
Status Explanation
Off The Wall Touch Screen is not in standby mode.
Solid The Wall Touch Screen is in standby mode.
Blinking The Wall Touch Screen is not in standby mode and searching for a signal.
System Use
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2.4 Proper System Handling
Inspection Prior to Use
Prior to surgery, test the device to ensure that it is functioning properly. Visually inspect the device
and all visible cables for damage. Turn on the display and the connected video/data source and
ensure correct operation. Do not use equipment if you suspect that it is damaged in any way.
If the wall on which the system is installed changes in appearance (e.g., cracks), do not use
the system and have an expert evaluate wall stability.
Do not place heavy objects (> 2 kg) on wall-mounted devices.
Risk of Electrical Shock
Warning
Never touch the patient and any system parts or electrical interfaces at the same time, due
to possible electrostatic discharge.
Do not touch the electrical contacts of plugs.
The mains supply line fuse must have an appropriate rating.
Connecting Cables
When connecting and disconnecting cables, observe the relevant information in this user guide.
Do not use damaged cables (e.g., damaged insulation, bare wires). Damaged cables present a
danger of electrical shock or fire.
Only use the power cables that have been provided with the system. The mains power cables
may only be exchanged by Brainlab or authorized service personnel.
Lay all cables so that nobody will stand on or trip over them. When connecting or installing cables
for the device, do not route the power cord where it can be tread on or pinched by adjacent
objects.
Pay particular attention to the plug, the electrical outlet, and the point where the cord extends from
the device.
Do not tug or pull at cables when establishing or opening a connection, but always pull at the
connector. Otherwise, the interface or connector might be broken and live parts become
accessible.
Ensure that there is sufficient slack when connecting cables. Do not strain or place the attached
cables under tension.
Modification
Warning
Do not modify the system in any way. Altering the system or using it outside of its intended
use may result in severe harm to the patient, user or third-party.
Shut Down If Not Used
Disconnect the Wall Touch Screen from mains power if not used for longer periods of time.
Restrictions to Environment
The device is not suitable for use in the presence of flammable anesthetic mixtures containing air,
oxygen or nitrous oxide.
Do not operate device in an environment with enriched oxygen.
SYSTEM COMPONENTS
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2.5 Use in an MR Environment
MR Conditional
Warning
The Wall Touch Screen is considered to be MR conditional within its intended use. This
applies only if the device has been mounted and accepted by Brainlab support. The device
must be disconnected from the mains during MR scanning.
Installation
The installation of the device is allowed only outside the 0.50 mT field contour (5 gauss (G) line).
During MR Scanning
The Wall Touch Screen must be disconnected from the mains power supply during MR scanning.
Disclaimer of Excluded Responsibility
Brainlab is not responsible for any changes to system behavior or the consequences thereof, if:
• Any system components or the system's installation are altered by the user.
• The system is used or operated differently than the descriptions provided in the Brainlab user
guides.
• Any safety information provided in Brainlab user guides is disregarded or violated.
Use in an MR Environment
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