Gymna PULSON 200, User Manual

Page: 28 / 56

Pulson 200
29
5 I
NSPECTIONS AND MAINTENANCE
5.1 Inspections
5.1.1 US head test
Test the US head if its conduction is bad. This is the case when the
indication bar for the Ppk value displays
or .
1. Select an ultrasound therapy.
2. Place the US head in a bowl with water.
3. Rotate intensity knob to start the treatment.
4. Check in the screen of the channel to see if the Ppk value is increasing.
5. Contact your local GymnaUniphy dealer if the indication bar still displays
or .
5.1.2 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.
5.1.2.1 Inspection points
The technical safety inspection contains the following tests:
1. Test 1: General: Visual inspection and check on the operating functions
2. Test 2: Ultrasound therapy
3. Test 3: Electrical safety inspection: measurement of the earth leakage
current and patient leakage current according to DIN/VDE 0751-1
ed. 2.0.
Component Check Frequency
US head Dents, cracks or other damage At least 1x per
month
Test US head See §5.1.1. With bad operation
or at least 1x per
year
Cable of US head Damage
Pins in connector straight At least 1x per
month
Equipment Technical safety inspection.
See §5.1.2. 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.