Testing Medical Electrical Systems - Brainlab CURVE Technical User Manual

ELECTRICAL SAFETY
4.4.1

Testing Medical Electrical Systems

Testing Precautions
• The described test only covers the Brainlab equipment and not the connected equipment.
Please additionally follow the description given by the manufacturer of the connected device.
• All devices shall be in operation mode: During the measurement all mains switches shall be in
operating position (ON).
• Tests shall be performed in normal condition as well as in single fault condition.
Required Test Steps
Steps
1.
2.
3.
4.
5.
NOTE: For details on the tests to be performed, see page 58.
Test Guidelines
When performing the test, keep the following points in mind:
• Perform required test steps in the order defined above.
• Measure all areas of the system indicated in the following chapters.
• All tests must be passed.
• The calibration of the measuring device must be valid at the time of measurement.
• Perform all tests according to IEC 60601-1:2005.
NOTE: The measurement outlet connection of the measuring device must remain established
during the entire measurement cycle. If you unplug the measurement outlet during measurement,
the measuring device recognizes that the connection is no longer established and you will need to
repeat the entire test.
If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the
entire electrical safety test from the beginning.
Safety Inspection Form
• Print out or make a copy of the safety inspection form starting from page 58.
• Enter the inspection results.
• Keep it as a record of the inspection.
Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2
Perform visual inspection.
Check touch current.
Perform functional test.
Report and evaluate results.
Check and prepare system for normal use.
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