Testing Medical Electrical Systems - Brainlab CURVE System And Technical User Manual

Testing Medical Electrical Systems

10.4.1 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.
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.
• Enter the inspection results.
• Keep it as a record of the inspection.
Related Links
10.4.2 Safety Inspection Form - Medical Electrical Systems on page 157
Required Test Steps
Step
1.
2.
3.
4.
5.
156
Perform visual inspection.
Check touch current.
Perform functional test.
Report and evaluate results.
Check and prepare system for normal use.
System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2