Inspections And Maintenance; Inspections; Technical Safety Inspection - Gymna VACO 200 Manual De Usuario

5 I
NSPECTIONS AND MAINTENANCE
5.1

Inspections

Component
Electrode cables
and electrodes
Equipment
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.
•
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.
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.
Vaco 200
Check
Damage
Insulation intact
Technical safety
inspection. See §5.1.1.
17
Frequency
At least 1x per month
At least 1x per year