Safety Inspection Form - Medical Electrical Systems - Brainlab CURVE System And Technical User Manual

ELECTRICAL SAFETY
10.4.2

Safety Inspection Form - Medical Electrical Systems

Tests to be Performed
Test Step
Visual Inspection
Touch Current
(Optical Tracking)
Touch Current
(EM Tracking)
Functional test
(Optical Tracking)
Functional Test
(EM Tracking)
Report and evaluate
results
System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
Instructions and Conditions
Check all relevant cables for dents, damaged isolation and blank lines.
Move and bend the cables around your hand to stretch the isolation
slightly. Any visible damage is not acceptable.
Check Monitor Cart and Camera Cart for visible damage, broken cables
and blank lines. With the exception of air vents, you should not be able to
see the interior of the carts. Damaged cables, blank lines or visibility of
the interior are not acceptable.
Check indicator LEDs (on the Monitor Cart and camera) for detected er-
rors.
If any damages are detected, place the device out of operation, mark as
such and contact Brainlab support.
Connect Monitor Cart and Camera Cart using the camera cable and
plug Monitor Cart into mains power supply using the original Brainlab
mains power cable.
Place the device that shall be connected into operating mode, as descri-
bed by the manufacturer of the device.
Connect the required cable to create the medical electrical system be-
tween the two devices and switch both devices on.
Test the equipment touch current according to IEC 60601-1:2005 Chapter
16.6.1 in normal condition and single fault condition. The interruption of
any non-permanently installed protective earth connection is considered
single fault condition.
Connect Monitor Cart and EM Tracking Unit (optional) using the con-
nection cables and plug the Monitor Cart into mains power supply using
the original Brainlab mains power cable.
Place the device that shall be connected into operating mode, as descri-
bed by the manufacturer of the device.
Connect the required cable to create the medical electrical system be-
tween the two devices and switch both devices on.
Test the equipment touch current according to IEC 60601-1:2005 Chapter
16.6.1 in normal condition and single fault condition. The interruption of
any non-permanently installed protective earth connection is considered
single fault condition.
• Power on the Curve system.
• Check that indicator LEDs (on the Monitor Cart and camera) do not
show detected errors. For detailed information on LEDs see the Sys-
tem User Guide.
• Start a software application.
• Accurately track a Brainlab instrument.
• Verify the actual function of the created medical electrical system.
• Power on the Curve system.
• Check that indicator LEDs (on the Monitor Cart and EM Tracking Unit
(optional)) do not show detected errors. For detailed information on
LEDs see the System User Guide.
• Start a software application.
• Accurately track a Brainlab EM instrument.
Generate a report and determine whether the device is safe and effective.
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