Safety Inspection Form - Medical Electrical Systems - Brainlab CURVE DUAL DISPLAY Technical User Manual

ELECTRICAL SAFETY
4.4.3

Safety Inspection Form - Medical Electrical Systems

Tests to be Performed
Test Step
Visual Inspection
Touch Current
Functional test
Report and evaluate
results
Check and prepare
for normal use
Critical Values
Test Step
Touch Current
Reference Dimension
Use the table starting on page 53 to enter the single measured values at each required
measurement point.
Enter the maximum measured value in the table below:
Technical User Guide Rev. 1.2 Curve Dual Display, Curve Single Display Ver. 1.0
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. If you are using a Curve Dual Display system, also
connect the Camera Cart - Dual Display to supply mains using the origi-
nal 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.
Generate a report and determine whether the device is safe and effective.
After testing, check that the Curve system 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.
Normal Condition
≤ 100 µA
Single Fault Condition
≤ 500 µA
51