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Section 7
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The manufacturer recommends that the VAPR Generator be regularly inspected to ensure
continued safety of operation throughout its service life. The following safety checks should
be performed at least every 12 months by a qualified person who has adequate training,
knowledge and practical experience to perform such tests.
CAUTION
Do not attempt to remove the cover of the generator or perform servicing on its parts.
• Inspect the Generator and the Footswitch for obvious signs of mechanical damage or
wear. Ensure that the Generator case shows no sign of tampering. There are no user
serviceable items within the Generator or Footswitch.
• Check that the Generator back panel label is present and decipherable and that the
front panel markings and symbols are still legible.
• Retract the fuse drawer of the mains inlet connector and verify that both fuses are
intact and match the rated current and breaking characteristics as per the back panel
label.
•
Verify that the resistance between the earth terminal of the mains inlet connector and
the Generator enclosure is within the limits defined in IEC 60601-1 or the corresponding
national standard as applicable.
• Switch on the Generator ensuring that the initial internal self-test completes normally
as reported on the front panel display. Check that the audio alarm, front panel warning
indicator and vacuum fluorescent display are functioning normally via the user
verification sequence which follows initialization.
• Check that the enclosure earth leakage current is within the limits for Class I equipment
as prescribed with IEC 60601-1 or the corresponding national standard as appropriate.
• Measure the patient earth leakage currents and ensure it is within the limits of BF type
equipment as defined within IEC 60601-1 or a corresponding national standard.
• Details of these tests should be recorded in an equipment log with the date of test
for future reference. Contact DePuy Mitek customer service should a unit fault be
suspected.
