GIMA SpA
DIATERMO 106
20
MA126IGBEa
Manuale d’istruzioni / Instruction’s Manual / Manual de Instrucciones
The electrosurgical equipment does emit unnoticed radiation of high frequency energy that may
effect other medical equipments, unrelated electronics, telecommunications, navigational systems.
2.2 INSTALLATION
The electric safety of
DIATERMO 106
is insured only when the same is correctly connected to an
efficient net linked to the earth in conformity with the actual safety requirements. It is neccessary
to verify this fundamental safety requisite and, in case of doubt, to require an accurate control of
the plant from part of qualified personnel. The manufacturer cannot be considered responsible for
possible damages caused from the lack of efficient connection to earth of the installation.
Operation without a protective earth connection is forbidden.
Before connect the equipment ascertain that the required voltage (showed on the rear panel)
corresponds to the available mains. The fuse holder is installed on the mains input connector
module.
In case of incompatibility between the available wall socket and the feeding cable of the
equipment, replace only with legally approved connectors and accessory items. The use of
adapters, multiple connections or cable extensions are not advised. Should their use become
necessary it is mandatory to use only simple or multiple adapter conforming to the actual safety
requirements.
The use of any electric apparatus involves the observance of some fundamental rules. Particularly:
don't touch the apparatus with wet or damp feet or hands.
don't use the apparatus with naked feet
don't let the apparatus exposed to atmospheric agents
Don't obstruct openings or cracks of ventilation or heathsink.
Don't leave the equipment uselessly inserted. Switch off the equipment when not in use.
DIATERMO 106
must be destined only to the use for the which has been expressly designed. Any
other use is to be considered improper and dangerous. The manufacturer can not be considered
responsible for possible damages due to improper, wrong and unreasonable uses.
It is dangerous to modify or try modify the characteristic of the equipment.
Before effect any operation of cleaning or maintenance, disconnect the apparatus from the electric
net, either unplugging it from the mains or switching off the mains switch of the plant.
In case failure and/or bad operation of equipment switch off it. For the possible reparation address
only to a authorized service center and ask for the the use of original spare parts. The lack to follow
the above requirements could risk the safety of the equipment and can be dangerous for the user.
Never lay the pen on the patient drape. Set it on the instrument tray when not in use. Accidental
activation can cause patient burns beneath the blade of the active electrode.
Do not reduce or disable the audible signal warning the activation of the generator. A functioning
activation signal can minimize or prevent patient or staff injiury in the event of accidental
activation.
2.3 APPLICABLE SAFETY STANDARDS
DIATERMO 106
conforms to the safety requirements of IEC 601-1/ EN 60601-1 (Medical electrical
equipment-General requirements for safety), and of IEC 601-2-2 / EN 60601-2-2 (Medical electrical
equipment - Particular requirements for the safety of high frequency surgical equipment).