6.2.3 Safety Inspection Form – Recurrent Tests
Test Steps to Be Performed
Step 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 isola-
tion. Any visible damage is not acceptable.
Check the Monitor 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.
Ensure that the Monitor Cart is correctly assembled, i.e.:
• The post is securely inserted into the cart base
• The monitor is locked into position on the post
• The monitor hinge securely holds the monitor in position
If any damages are detected, place the device out of operation, mark as
such and contact Brainlab support.
Protective earth re-
sistance
Plug the Monitor Cart into mains power supply using the original Brainlab
mains power cable. If you have multiple mains power cables for your de-
vice, repeat this test with each cable.
Test the protective earth resistance according to IEC 62353:2007 Chapter
5.3.2.2 using a measuring device capable of delivering a current of at
least 200 mA into 500 mΩ. Perform measurement for one second. The
open circuit voltage must not exceed 24 V.
Equipment leakage
current
Plug the Monitor Cart into mains power supply using the original Brainlab
mains power cable. Test the equipment leakage current according to IEC
62353:2007 Chapter 5.3.3.2.3 using the so-called “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
Functional test
• Power on the Monitor Cart
• Load patient data and start a software application
• Check that touchscreen interaction is accurate
• Accurately track a Brainlab instrument
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 Monitor Cart 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).
Critical Values
Test Step
Normal Condition
Protective earth resistance
≤
0.3 Ω
Equipment leakage current
≤
0.5 mA
Safety Inspection Form – Recurrent Tests
70 System and Technical User Guide Rev. 1.3 Kick 2 Navigation Station
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