4 Testing and Maintenance
Other Regular Tests
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Evaluation of Test Results
The evaluation of the test results must be performed by appropriately trained personnel with sufficient
product, safety testing and application knowledge.
If any test results are between 90% and 100% of the respective expected result, the previously
measured reference values must be taken into consideration for the assessment of the electrical safety of
the device under test. If no reference values are available, you should consider shorter intervals between
upcoming recurrent tests.
N O T E
If any single test fails, testing must be discontinued immediately and the device under test must be
repaired or labeled as defective. Be sure to inform the user about the test failure in writing.
Other Regular Tests
The care and cleaning requirements that apply to the monitor and its accessories are described in the
Instructions for Use. This section details periodic maintenance procedures recommended for the
monitor and its accessories.
After Installation, Testing or Repair
Before handing the patient monitor over to the end-user, make sure it is configured appropriately and
that it is in monitoring mode. Ensure that the user receives the current revision of the monitor
documentation.
Notes
Next Recurrent Test:
Name:____________________________________________________
Date/Signature:_____________________________________________