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5
SYSTEM OVERVIEW
• The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system
should be observed to verify normal operation in the configuration in which it is used.
• Refer to the Guidance and Manufacturer’s Declaration section for EMC (Electromagnetic Compatibility) information.
• In order for the Generator to be able to fulfill its intended clinical function effectively, a maximum cord and accessory length of 4.5
meters between the Generator and accessories is defined for Bipolar Accessories, 3.2 meters is defined for Monopolar Accessories
and 3.0 meters for Neutral Electrodes.
• The use of accessories, transducers and/or cords other than those specified, except for those sold by the manufacturer as
replacement parts for internal components, could result in increased emissions or decreased immunity of the equipment or system.
• The application of a current with high voltage, and in particular of a high voltage monopolar coagulation current, may cause
neuromuscular stimulation in the patient.
• When vaporizing tissue, do not inhale the combustion fumes that form by design over a longer period in concentrated form. During
regular use of the Generator, no pollutants other than these combustion products will be formed. For removal of such combustion
products, a fume suction system can be used.
Precautions
• The Generator must be separated from other electrosurgical devices and their cords. Close proximity to the Generator and its cords
to electrosurgical units that produce excessive RF current radiation could cause the Generator to change output power. Surgical
electrode cords must be positioned to avoid contact with the patient or other leads. Temporarily unused active electrodes should be
stored in a location that is isolated from the patient.
• Do not operate the Generator at temperatures below 50°F (10°C). Allow the Generator to warm up to at least 50°F (10°C) before use.
• Visually inspect the power cord, bipolar cord and Foot Pedal for damage prior to each use. Connect Foot Pedal, adjust Generator to
desired power seing, and activate Foot Pedal to verify proper function. Replace accessories if necessary.
• Non-insulated bipolar forceps are not recommended for use with higher power seings. When higher power seings are employed,
insulated bipolar forceps are recommended.
• Keep bipolar instrument tips clean. Build-up of eschar may reduce the instrument's effectiveness. Do not activate the instrument
while cleaning, as injury to operating personnel may result.
• The Generator is designed for use without a neutral electrode while operated in bipolar modes.
• The Generator does not generate waste. Disposable products used with the Generator must be disposed of in accordance with
hospital procedures and regulations.
• Always position Generator so that the power cord can be easily unplugged from the rear panel.
• The output power should be set as low as is necessary to achieve the desired effect.
• Anyone who connects additional units to the input or output section thereby configures the system and is thus responsible for
compliance with section IEC 60601-1:16.
• In order to be able to completely separate the unit from the grid in the event of danger, either the power socket of the unit or the
outlet into which the mains cable is plugged should remain accessible.
Wiping
• Wipe the exterior surfaces of the Generator as necessary with a so, damp cloth or sponge. Use 70% Isopropyl Alcohol wipes or a
mild cleaning solution to remove stains or adhesives that stick to the surface. Subjecting the Generator to excessive moisture can
damage the electronic components and nullify the warranty.
• Never sterilize the Generator.
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