Brainlab 19179 User manual

Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
Customer Support:
[email protected]
North/ South America: [phone]
Europe&Rest of the world: [phone]
page 1/2
a
BL-IL-60960-34EN Rev2.0
*60960-34EN*
Converter Kit DVI to S-Video 19179
ENGLISH
Intended Use
The Converter Kit is intended to be used by surgeons or other
clinical personnel in OR environment during image guided
surgery (IGS) for integration of video signals from video sources
with only DVI-output to navigation platforms without DVI-IN
interfaces.
Overview
No.
Component
①
S-Video OUT
②
Mains Power Connector
③
Ports for Video and Audio Output
④
HDMI Video IN
⑤
USB (for service purposes only)
⑥
Power Supply Connector
Power LED Status
Color
Status
Explanation
Blue
Off
No power connection, electronic
components are off
Solid
Connection to mains power,
electronic components are on
Compatibility
Only use the Converter Kit with Brainlab navigation systems:
Kick
Curve
Only use compatible C-arms.
For a complete compatibility list, contact Brainlab support.
Brainlab accepts no liability if unapproved scanners or C-arms
are used.
Video Connections
Port
Example
Handling
S-Video
OUT
Connect the Converter Kit to
the Brainlab navigation
system with an S-Video cable
to interact with Brainlab
software video.
HDMI
IN
Connect the DVI video
source to the Converter Kit
with a DVI to HMDI cable.
NOTE: Use a high quality
HDMI cable to connect a
HDMI source.
Do not place the Converter Kit in the patient environment.
Additional equipment connected to medical electrical
equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore, all
configurations shall comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16
of the 3rd edition of IEC 60601-1, respectively). Anyone
connecting the Converter Kit to medical electrical
equipment configures a medical electrical 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. If in doubt, consult your local representative
or the technical service department.
NOTE: Unless otherwise specified, the use of multiple socket
outlet(s) is not permitted.
Startup Test
Perform a functional test before first use at each day of use. To
do this, the Converter Kit must be connected to the video
source and the Brainlab navigation System as described above.
Verify that the image shown on the Brainlab navigation system
is correct.
Cleaning the Converter Kit
The Converter Kit can be cleaned with disinfectants containing
- Alcohol 50%/60%, e.g. Meliseptol
- Alkylamine 0,7% (in 2% solution), e.g. Incidin Plus 2%
- Active Oxygen 1,35% (in 3% solution), e.g. Perform
- Aldehyde 1% (in 4% solution)
- Chloride 0,4% (in 4% solution)
How to clean the Converter Kit
1. Shut down the system by unplugging the mains power.
2. For cleaning and disinfection, use a moist cloth and
clean all surfaces using a surface disinfectant. Follow the
disinfectant manufacturer’s recommendations.
3. Carefully clean interfaces, ensuring that no liquids enter
the system.
4. For cleaning of all other devices refer to the respective
Instruction for Use.
Storing the Converter Kit
Use the delivered transportation bag to store or transport the
Converter Kit.
How to store Converter Kit
1. Unplug the mains power and disconnect all video cables.
2. Clean the Converter Kit and put it into the transportation
bag.
3. Coil up each cable and put them into the transportation
bag.
Trouble Shooting
Problem
Possible Cause
No Power
Check that the mains power cabling is
correctly connected to power supply.
No Image
Check that all video cables are correctly
connected.
Expected Service Life
Brainlab provides a minimum of eight years of service for
devices.
④
⑥
⑤
①
②
③

Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
Customer Support:
[email protected]
North/ South America: [phone]
Europe&Rest of the world: [phone]
page 2/2
a
BL-IL-60960-34EN Rev2.0
*60960-34EN*
Converter Kit DVI to S-Video 19179
1 Electrical Safety
1.1 Classification
The Converter Kit is classified as Class II Equipment
according to IEC 60601-1 and has to be tested accordingly.
Classification
Definition
Class II
Electrical equipment in which protection
against electric shock does not rely on
basic insulation only, but in which
additional safety precautions such as
double insulation or reinforced insulation
are provided, there being no provision for
protective earth or reliance upon
installation conditions.
1.2 Test Interval
For details on the test interval including training requirements
for test personnel please refer to the Technical User Guide of
the Brainlab navigation system.
1.3 Test Steps to be performed
Steps
Instructions and Conditions
Visual
Inspection
Check all relevant cables for dents,
damaged isolation and blank lines. Move
and bend the cables around your hand to
slightly stretch the isolation. Any visible
damage is not acceptable.
Check the Converter Kit for visible
damage, broken cables and blank lines.
You should not be able to see the interior
of the Converter Kit or the power supply.
Damaged cables, blank lines or visibility of
the interior are not acceptable.
If any damage is detected, remove the
device from operation, mark as such and
contact Brainlab support.
Protective
Earth
Resistance
(Power Cable
only)
Resistance between protective connectors
at each end of the detachable Power
Cable.
Equipment
leakage
current
Plug in Converter Kit mains power supply
using the original Brainlab mains power
cable. Test the equipment leakage current
according to IEC 62353:2014 Chapter
5.3.4.2.4 using the “differential method”
with the following additional conditions:
Measurements are performed at
mains voltage.
Measurements are performed in
both positions of the mains plug, if
possible.
When measuring in the various positions of
the mains plug, document the higher value.
Insulation
Resistance
Connect the Converter Kit to your
measuring device using the provided
Brainlab mains power cable. Test the
insulation resistance according to IEC
62353:2014 Chapter 5.3.3
Report and
evaluate
results
Generate a report and determine whether
the device is safe and effective.
Check and
prepare for
normal use
After testing, check that the Converter Kit
is restored to the conditions necessary for
normal use before being returned into
service. Remove all devices that have
been connected, e.g., measurement lines.
1.4 Equipment Leakage Current Test
Connect the measurement tip of your measuring device with the
conductive parts shown below and measure the leakage
current.
Measurement Point
Measured
Value
Passed?
Screw for
HDMI-plug
fixation
USB port
1.5 Protective Earth Test (Power Cable only)
Measurement
Measured
Value
Passed?
Protective Earth resistance of
power cable
Insulation Resistance Test
Connect the Converter Kit using the Brainlab mains power
cable to the electrical safety tester and test the insulation
resistance. The electrical safety tester shows whether the
device passes or fails.
Measurement
Measured Value
Passed?
Insulation resistance test
with 500 Vdc for five
seconds
1.6 ME System
When the Converter Kit is connected to the Brainlab
navigation system and the video source, e.g. a C-arm, the
responsible organisation has to conduct an enclosure leakage
test according to IEC 62353. For applicable measuring points
see the Instructions for Use of the Converter Kit, the Brainlab
navigation system and the video source, e.g. C-arm.
The ME System may exceed threshold values for ME
Equipment leakage current specified in IEC 60601-1: 2012.
2 Specifications and Compliances
2.1 Electrical Standards
Certificates
IEC60601-1
Electrical Standard Approval
by EN 60601-1 (IEC 601-1)
Protection Level I
IEC529
IP20
2.2 Physical Characteristics
Height
180 mm
Width
200 mm
Depth
40 mm
Weight
1 kg with out cables / 2 kg with cables
2.3 Technical Specifications
Video Input
1280 x 1024 / 60 Hz
Video Output
PAL 576i/25
Input Voltage
100 - 240 Vac
50 - 60 Hz
Power
Consumption
max. 10 VAC
2.4 Cable Specifications
System cables which have been tested for emission and
immunity conformity
Cable
Specification
Power Cable
Provided by Brainlab; 4-5 m long
DVI- D to
HDMI Cable
DVI-D male plug
HDMI, Type A, 19-pin, male plug
max. 4 m
S-Video Cable
Shielded 26 AWG miniature coaxial cable
with Mini-DIN Hosiden plug, max. 10 m
2.5 Compliances
Refer to the Technical User Guide or System User Guide of
your Brainlab navigation platform.
2.6 Environmental Conditions
Specification
Operating Conditions
Temperature
+10 °C (50 °F) to +35 °C (90 °F)
Humidity
30% to 75% non-condensing
Pressure
700 hPa to 1060 hPa
Specification
Storage Conditions
Temperature
-10 °C (14 °F) to +45 °C (113 °F)
Humidity
10% to 90% non-condensing
Pressure
500 hPa to 1060 hPa
For further information please see Brainlab's user manual
or consult Brainlab customer support.