GB User Manual
Operator regulation
According to Council Directive 93/42/EEC, the device is classified as medical device unit class IIb. Thus all directions of the
European operator regulation apply.
Technical controls:
The user is committed to perform technical controls on a regular basis conforming to the following specifications:
Period: Every 24 months, starting with the date of delivery and after each repair.
Covering:
Visual check of the unit and accessories
Check according to IEC 62353 (VDE 0751)
- Protective earth resistance
- Alternate leakage current
- Alternate patient leakage current
Function check
- Main switch
- Touch display
- Receptacles switch
Measurement of radio frequency (RF) output power at a load of 1 kΩ:
- Output CUT (50W)
- Output COAG (45W)
- Output (45W)
All results of measurements must be documented according to DIN EN ISO 62353 (VDE 0751) concerning the first measured values. If
defects occur during the controls, the user is responsible to initiate repair.
Preparation to start the device
• In order to avoid condensed water, make sure the device has been at room temperature for at least 30 minutes before you use it
Start up
• Connect foot switch with device.
• First of all connect the power supply cable to the device, then connect it to the house power output.
• Equip the RF-handpieces with the appropriate electrode, by slightly loosening the handle tip.
• Put the hand pieces in the receptacles and connect the radio frequency (RF) cable to the device.
Please pay attention to the marks (coloured).
• Connect the neutral electrode.
• Press the on/off power switch (back of device).
• The device will IMMEDIATELY start with a self test.
Taking out of operation after use
1. Put the hand piece into the receptacle
2. Remove the electrode and reprocess it accordingly
3. Put the main switch 3 (back of the device) into zero position
26