5
cleaning or disinfecting the unit with flammable or explosive agents is unavoidable,
these must be completely evaporated from the HF Radio Surgical Generator before it
is switched on.
2.6.4.2
Handpiece and Electrodes
Cleaning:
Tissue residue can be removed from the active electrode with a sterile, moist cloth,
steel or copper wool. No scalpel, scissors or similar pointed objects must be used for
cleaning the electrodes, since they will damage the electrode surface. Such damage
increases adhesion of tissue to the surfaces of the electrodes during use.
Disinfecting:
Always clean and disinfect the electrodes in a disinfecting solution prior to sterilizing
them. All commercially available disinfectants may be used.
Sterilization:
Steam sterilize for 3 to 10 minutes for prevacuum, or gravity displacement (flash), at
132˚ to 135˚C (270˚ to 275˚F), 2.2 bar (32 PSI).
Disclaimer:
All autoclavable products have an indefinite shelf life. These items should be routinely inspected for any wear,
breaks, or deterioration of the insulation, and should be discarded and replaced if any of these common occurrences exist.
2.6.4.3
The dual footswitch is a waterproof unit, it can be cleaned with regular detergent.
2.6.5
The equipment is not suitable for use in the presence of a FLAMMABLE ANESTHETIC MIXTURE
WITH AIR OR WITH OXYGEN OR NITROUS OXIDE.
2.6.6
The mode of operation is continuous operation with intermittent loading, duty cycle 10 seconds
on/30 seconds off.
2.6.7
The permissible operational environment conditions:
ambient temperature range
------ +10° C~ +40°C
relative humidity range
------ 30% ~ 75%
For transport and storage:
ambient temperature range
------ -10° C ~ +50°C
relative humidity range
------ 10%~95%
atmospheric pressure range
------ 500hPa~1060 hPA
This unit has been checked for proper and safe operation prior to shipment. However, all
equipment should be rechecked for proper and safe operation prior to initial operation, and before
each subsequent use.
2.7
PREVENTIVE INSPECTION AND MAINTENANCE
Regularly preventive inspection should be carried out to prevent reduced safety of the unit due to aging,
wear and tear, etc. The cable and electrode must be checked before each use.
The Wolf /
ellman
Surgitron 4.0 Dual RF/120 IEC High-Frequency Radiosurgical Generator must be
inspected for technical safety at least once a year. These technical safety inspections mean:
• Inspection of electrical safety in compliance with IEC 60601-1 and 60601-2-2
• Inspection for damage to the unit and its accessories
• Inspection of proper function of the unit
ATTENTION: Alcohol must never be used to clean and disinfect the front panel. We
recommend that the panel be disinfected by spraying or wiping.
However, it is essential to follow the manufacturer’s directions
regarding cleaning, disinfecting and sterilizing of the accessories.
