Instructions for Use
Electrosurgical Unit ME 102
24
V. 3.1
5
Safety Measures
5.1
General Information
Electrosurgical devices are high-frequency generators designed to create high voltages and
currents. In order to avoid hazards to the patient, the operators and third parties, the
procedure must be applied carefully, and the operating and safety notes must be strictly
observed. A defect in the RF unit may lead to an unintended increase of the output power.
Therefore, a protective circuit to avoid overpowering is integrated into the unit.
WARNING
Risk of injury from too low power setting!
Set the RF power for the desired surgical effect to the lowest possible setting. On the other
hand, it should also be kept in mind that too low power settings may also pose a risk, e.g. if
due to insufficient power no cutting is achieved and local coagulation results where it is not
desirable or even dangerous.
The unit may be used only by persons trained in the proper and safe use of the unit. The
Instructions for Use are to be adhered to in instruction and application.
Safe use of electrosurgery requires the user to be familiar with the technology and the
applications.
5.2
Patient Placement
•
The patient must be placed isolated from grounded metal parts. Particular care is required
to ensure that the patient's limbs do not touch any metal structures either.
•
Ensure the required high-frequency insulation against the operating table by a sufficient
number of layers (insulating blankets). Since during the operation moisture, perspiration,
etc. are to be expected, a waterproof foil must be used to prevent wetting of these layers
which serve as high-frequency insulation.
•
Fluid accumulation under the patient must be avoided under all circumstances. Use further
dry cloth layers where appropriate.
•
Keep areas with stronger perspiration, extremities touching the trunk or skin-on-skin
contact apart from each other and dry (arm-trunk, leg-leg, breasts) using insulating
blankets.
•
The above requirements for insulation must also be fulfilled if the patient is repositioned
during the operation.