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maxium® smart C Electrosurgery Unit with maxium® smart Beam
Revision 1
17
5
Risk Minimization and Safety Measures
Risk of serious injury in case of improper use!
Electrosurgery units comprise generators for high-frequency electrical energy, which can have high
amperage and voltage by design. In order to avoid hazards to the patient, the operators and third parties,
the procedure must be applied carefully. It is imperative to strictly observe and comply with all operating
and safety instructions.
As the maxium® smart Beam and other accessories will always be operated in combination with the
maxium® smart C, all safety instructions for the maxium® smart C also apply fully to the combination with
the maxium® smart Beam and any other accessories.
Possible malfunction of pacemakers and other active implants!
Electromagnetic interference from electrosurgical devices may disturb or completely block pacemakers or
other active implants!
For further information, refer to section 5.5, page 25.
5.1
Risks from Stray Currents
In the schematic representation of the flow of the current through the patient in section 4.2 “Monopolar
application of HF current”, page 14, the HF current entering the patient from the active electrode seems to
always return directly to the neutral electrode. In practice, a part of the electricity takes detours where
possible, and then HF currents will occur in positions where they are not expected to. Basically, here
according to the nature of the danger three types of stray currents are to be distinguished:
•
Currents via patient shunts
•
High-frequency and low-frequency leakage currents
•
Leakage currents through other medical devices
These currents are generally insignificant, as they amount only to a small fraction of the total electricity
produced by the generator. If, however, they concentrate in small places on the body, burns may result.