Cosman G4 - General Information; Device Classification; Electrical Safety and EMC Standards; General Safety Warnings

Cosman G4 Radiofrequency Generator Service Manual (SPI 11291 Rev A)
Section 1
1. General Information
Safe and effective RF lesioning is dependent not only on equipment design, but also on factors under
control of the operator. Do not attempt to operate the G4 prior to completely reading and
understanding the instructions for use.
WARNING: Electric Shock Hazard
There are no user serviceable parts inside the G4. To avoid
electric shock, return the device to Cosman for servicing.
WARNING: Hazardous Electrical Equipment & Active Implants
This equipment is intended for use by qualified personnel only.
This equipment may damage or interfere with the operation of cardiac
pacemakers and other active implants.
Do not use within 15 feet (4 meters) of a cardiac pacemaker unless proper
cautions have been taken. Before use of the Generator, contact the
pacemaker company to determine whether the pacemaker needs to be
converted to fixed rate pacing during the radiofrequency procedure. When
the pacemaker is in the sensing mode, it may interpret the RF signal as a
heartbeat and may fail to pace the heart.
This equipment has an output which is capable of causing a
physiological effect.
WARNING: Risk of Burns and Fire.
Do not use near conductive materials such as metal bed parts or inner
spring mattresses.
WARNING: Protective Earth Grounding
Grounding reliability can only be achieved when the equipment is
plugged into a receptacle marked “Hospital Grade”. Any
interruption of the Protective Earth conductor will result in a
potential shock hazard which cause injury to patient or operator.
1.1 Device Classification
Classifications as per EN 60601-1, the manufacturer describes the G4 as:
Type of protection against Electric Shock
Class I
Degree of protection against Electric Shock
Type BF Defibrillator Protected
Degree of harmful ingress of water
IPX0 Ordinary
Mode of Operation
Continuous use
Degree of Safety in the Presence of Flammable
Anesthetic Mixture with Air, Oxygen, or Nitrous
Oxide
Not suitable for use
1.2 Electrical Safety and EMC