ELECTRICAL SAFETY
Step
Applied Part Leak-
age Current (type
BF)
(EM Tracking only)
Functional test
(Optical Tracking)
Functional test
(EM Tracking)
Report and evaluate
results
Check and prepare
for normal use
Critical Values
Test Step
Protective earth resistance
Equipment leakage current
Applied Part Leakage Current (type BF) (EM
Tracking only)
Reference Dimension
Use the table starting on to enter the single measured values at each required measurement
point.
Enter the maximum measured values in the table below:
Test Step
Protective earth resistance
Equipment leakage current
Applied Part Leakage Current (type BF) (EM
Tracking only)
Serial number of measuring device: ________________________
Calibration valid through (date): __________________________
Test performed (date):_________________by: __________________________________
System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2
Instructions and Conditions
Connect Monitor Cart and EM Tracking Unit using the provided connec-
tion cables. Plug Monitor Cart into the Tester using the original Brainlab
mains power cable.
Test the equipment leakage current according to IEC 62353:2014 Chapter
5.3.4.3.2 using the so-called "alternative measurement", see Image 9 in
IEC 62353.
• 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.
• Power on the Curve system.
• Check that indicator LEDs (on the Monitor Cart and EM Tracking
Unit) 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.
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
≤ 0.3 Ω
≤ 500 µA
≤ 5 mA alternative measurement
Normal Condition
Passed?
149
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