Erbe ERBOTOM ICC 350 M, Instruction Manual

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4.3.1 Low-frequency leakage current monitor
The ERBOTOM ICC 350 can optionally be operated in Floating
Output or in Earth Referenced Output mode. These modes
can be changed over by a technician authorized to do this (see
Chapter 10.13). In the Floating Output mode, the low-frequency
leakage curent generally represents no problem, because the
applied part here is extensively insulated to ground potential. In
the Earth Referenced Output mode, the neutral electrode within
the unit is capacitively related to ground potential. A low-frequency
leakage current higher than 0.05 mA can flow through this capacity
if need be. For this reason, the ERBOTOM ICC 350 is equipped
with an LF leakage monitor which automatically monitors the LF
leakage current flowing through the patient via the applied part of the high-frequency surgical
unit. If the LF leakage current rises above 0.05 mA, the LF leakage monitor automatically separates
the capacitive ground for the neutral electrode within the unit immediately, which decreases the
LF leakage current to less than 0.05 mA. This error is indicated visually as Error no. 5 and
acoustically. The HF generator can only be activated once the cause of error has been eliminated.
In this way, the ERBOTOM ICC 350 also fulfills the Type CF requirements in the Earth
Referenced mode.
4.3. Description of the safety features
The ICC 350 is equipped with the following safety features:
4.3.1 LF LEAKAGE = Automatic monitoring of low-frequency leakage currents
4.3.2 HF LEAKAGE = Automatic monitoring of high-frequency leakage currents
4.3.3 OUTPUT ERROR = Automatic monitoring of unit-related output error
4.3.4 TIME LIMIT = Automatic monitoring of the time limit
4.3.5 NESSY = Neutral Electrode Safety System
4.3.6 Protection against operating error
4.3.2 High-frequency leakage monitor
HF leakage currents are unavoidable during high-frequency surgery.
This especially applies to all monopolar application techniques.
To prevent HF leakage currents flowing uncontrolled through the
patient and causing unintentional burns, patients should have no
contact with electrically conductive objects during high-frequency
surgery. This especially applies to objects that are conductive or
capacitively grounded. If this requirement is fulfilled, burns on
patients due to HF leakage are avoidable.
In EN 60 601-2-2, Sec. 19.101, the maximum permissible HF
leakage current which cannot cause noticeable burns on patients
is given as 150 mA.