Cosman G4 Service Manual page 8

Cosman G4 Radiofrequency Generator Service Manual (SPI Rev A)
11291
WARNING: Apparent low power output or failure of the equipment to function
correctly at normal settings may indicate faulty application of the dispersive
electrode or failure of an electrical lead. Do not increase power before checking for
obvious defects or misapplication. Effective contact between the patient and the
dispersive electrode must be verified whenever the patient is repositioned after the
initial application of the dispersive electrode.
WARNING: Electromagnetic interference (EMI) produced by the unit during normal
operation may adversely affect the performance of other equipment. The
performance of this device may be adversely affected by other high frequency
surgical devices in close proximity. If a problem occurs, separate the devices.
WARNING: The use and proper placement of dispersive electrodes is a key
element in the safe and effective use of this lesion generator, particularly in the
prevention of burns. Read and follow Cosman's dispersive electrode instructions for
preparation, placement, surveillance, removal and use of any dispersive electrode.
The use of dispersive electrodes that meet or exceed ANSI/AAMI requirements
(HF18) is recommended.
WARNING: Use the Cosman's DGP-PM large area dispersive electrode, a large
area gel-pad (with a 110 cm² conductive plate area) or an equivalent gel-pad
dispersive electrode (with at least 110 cm² conductive plate area) to disperse and
return RF current over as large an area as possible, and thus minimize heating
effects at that electrode, and to avoid high current densities and resultant burns in
adjacent tissue.
NOTICE: The ground pad should be placed in close proximity to the lesion site.
WARNING: Observe the dispersive electrode during lesioning for signs of excessive
heating.
WARNING: The long-term risks of creation of RF lesions have not been
established.
WARNING: The generator is capable of delivering a significant amount of output.
Patient or operator injury can result from improper handling of the active electrode
and dispersive electrode, particularly when operating the generator. During energy
delivery, the patient should not be allowed to come in contact with metal parts which
are earthed or which have an appreciable capacitance to earth. The use of
antistatic sheeting is recommended for this purpose. Unshielded leads (active or
return) should be positioned so that they cannot come into contact with the patient
or other leads connected to the patient and so that they do not run parallel to nearby
leads.
WARNING: Electrodes and probes of monitoring, stimulating, and imaging devices
can provide paths for high frequency currents even if they are battery powered,
insulated, or isolated at 60 Hz. The risk of burns can be reduced. But not
eliminated, by placing the electrodes or probes as far away as possible from the
lesion site and from the dispersive electrode. Protective impedances incorporated
into the monitoring leads may further reduce the risk of these burns and permit
continuous monitoring during energy delivery. Needles should not be used as
monitoring electrodes during such procedures.
Section 1