Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)
Section 1
The G4 has been tested to and meets the requirements of the following Electrical Safety Standards:
EN 60601-1 Medical Electrical Equipment (1990, A1: 1993, A2: 1995, A13: 1996)
EN 60601-2-2 Particular Requirements for the Safety of High Frequency
Surgical Equipment (2006)
The G4 has been tested to and meets the requirements of the following EMC Standards:
EN 60601-1-2 Collateral Standards: Electromagnetic Compatibility (2001, A1: 2004)
The following standards apply:
CISPR 11/FCC Part 15 Group 1, Class A, ISM
IEC 61000-4-2 (2001), 61000-4-3 (2006), 610004-4 (2004), 61000-4-5 (2005)
1.3 Electrical Safety Information
The G4 is a radiofrequency generator designed to produce local tissue heating at the tip of an electrode
by the presence of radio frequency current. Special isolation transformers are imposed between power
lines and internal G4 circuitry, resulting in very low leakage current.
WARNING:
needle electrode should not be used as the dispersive electrode, as it
is possible to burn the patient at this site due to high current densities. In all
applications, care should be taken to maximize the surface area of the dispersive
electrode. The dispersive electrode should be reliably attached with its entire area
against the patient’s body and as close to the operating field as possible.
The risk of igniting flammable gases or other materials is inherent in lesioning and cannot be eliminated
by device design. Precautions must be taken to restrict flammable materials and substances from the
electrosurgical site. The use of flammable anesthetics and nitrous oxide and oxygen should be avoided,
unless these agents are suctioned away. Flammable agents used for cleaning or disinfecting should be
allowed to evaporate before the application of RF surgery. There is a risk of flammable solutions
pooling under the patient and in body cavities. Any fluid pooled in these areas should be removed
before the equipment is used. Avoid use of flammable materials, such as gauze or cotton wool when
saturated with oxygen. These materials may be ignited by sparks produced in the normal operation of
the G4.
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