SECTION 13 PERIODIC EQUIPMENT SAFETY CHECKS
Gyrus ACMI PlasmaKinetic SuperPulse Generator
USER MANUAL
Part Number: 144012-MB
Page 13-1
The manufacturer recommends that the Generator and Footswitch should 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.
NOTE
:
There are no user serviceable items within the generator.
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 EN 60601-1 or the corresponding
national standard as applicable.
Switch on the Generator, ensuring that the initial internal self-test is completed 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 Desiccation detector operation.
Check that the enclosure earth leakage current is within the limits for Class I equipment
as prescribed within EN 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 EN 60601-1 or a corresponding national standard.
If there is any doubt about the PK RF output power of the generator, it must be returned
to the supplier for testing. A power output assessment may be performed on the bipolar
output by using the connections described below. The output may be compared to the
load curves specified in the previous sections. The output should be within ±20% of the
relevant curve. The diathermy tester must be rated to read Watts at the appropriate
frequency and have non-reactive loads. All connections should be insulated wherever
possible to prevent electric shock risk and short-circuiting. The generator sockets receive
two and four millimeter diameter plugs.
To measure Desiccate outputs up to 150 Watts C1 shall be 4.7 nF +/- 1%.
To measure PK outputs up to 200W C1 shall be 68nF +/-10%.
Due to the pulsing nature of the SuperPulse and TS outputs, accurate measurements are
difficult to carry out without specialized equipment.
Details of these tests should be recorded in an equipment log with the date of test for
future reference. Contact the service repair center selected by the manufacturer, should a
unit fault be suspected.
SECTION 13
PE
R
IODIC EQUIPMENT SAFETY CHECKS
Содержание PlasmaKinetic SuperPulse
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