Use Instructions

ELST026-AUM001-V0.6.2 Page 46 of 68
5 INSPECTIONS AND MAINTENANCE
5.1 Inspections
Component
Check
Frequency
hand piece:
cable, connector
‘damage’
insulation intact
PINS in connector
at least 1x per month
hand piece:
buttons & coloured
Illuminated ring
‘functionality’
see § 4.7.1
at least 1x per month
electrode cable &
rubber electrode
‘damage’
insulation intact
at least 1x per month
electrode cable &
rubber electrode
‘conductivity’
see § 4.7.1
at least 1x per month
main device
‘technical safety
inspection’
see § 5.1.1, § 8.2
at least 1x per year
5.1.1 Technical safety inspection
The ‘Directive on Medical Devices’ from the European Commission (93/ 42/EEG) requires devices
to be safe. 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.
Note:
 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 contains the following tests:
Test 1: General: Visual inspection and check on the operating functions
Test 2: Electro therapy
Test 3: Handpiece
Test 4: Electrical safety inspection: measurement of the enclosure leakage current and patient
leakage current according to IEC 62353.