Vaco 200
17
5
I
NSPECTIONS
AND
MAINTENANCE
5.1
Inspections
5.1.1
Technical safety inspection
The 'Directive on Medical Devices' from the European Commission (93/
42/EEG) requires that safe devices are used. It is recommended to
perform a yearly technical safety inspection. If the legislation in your
country or your insurer prescribes a shorter period, you must adhere to
this shorter period.
Inspection points
The technical safety inspection include the following tests:
1. Test 1: General: Visual inspection and check on the operating
functions
2. Test 2: Electrical safety inspection: measurement of the earth
leakage current and patient leakage current according to DIN/VDE
0751-1 ed. 2.0.
Inspection result
1. A registration must be maintained of the technical safety
inspections. Use the inspection report in the appendix for this
purpose. See
§8.1
.
2. Copy this appendix.
3. Complete the copied appendix.
4. Keep the inspection reports for at least 10 years.
Component
Check
Frequency
Electrode cables
and electrodes
Damage
Insulation intact
At least 1x per month
Equipment
Technical safety
inspection. See
§5.1.1
.
At least 1x per year
•
Only a technician authorised by GymnaUniphy N.V. may
open the equipment or the accessories.
•
The inspection may only be performed by a suitably
qualified person. In some countries this means that the
person must be accredited.
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