4
2.1.2
Neutral Plate
NOTE:
See Neutral Plate Instructions for Use for detailed device and use
information.
2.1.2.1 The use and proper placement of the neutral plate is essential to the safe
and effective use of this device in order to prevent burns from the neutral
plate. The neutral plate should be reliably attached with its entire area
attached to the patient’s body as close as possible to the operating field.
The neutral plate must make complete skin contact.
2.1.2.2 Use only Ellman supplied neutral plates.
2.1.2.3 To prevent burns at site of neutral plate, use lowest possible output
settings, ensure proper patient preparation, and/or limit duration of
activation.
2.1.2.4 When performing procedures requiring high power and long duration
(eg, wrinkle treatment), ensure use of the largest Ellman neutral
electrode available and that its entire surface area is adhered to the
patient.
2.1.2.5 Ensure the neutral pad is placed in closer proximity to the patient's
treatment area than any ground referenced patient contact points such as
monitoring electrodes.
2.1.3
Flammable Environment
2.1.3.1 Some materials, for example cotton, wool, and gauze when saturated with
oxygen may be ignited by sparks produced in normal use of the equipment.
2.1.3.2 Do not use the Surgitron
®
Dual/EMC in the presence of flammable
anesthetics or other flammable gases, flammable liquids, or flammable
objects.
2.1.3.3 Do not use this device in oxygen enriched atmospheres or in the
presence of nitrous oxide (N20).
2.1.3.4 Use only non-flammable agents for cleaning.
2.1.3.5 Flammable agents used as solvents for removing adhesives should be
allowed to evaporate before powering on the Surgitron
®
Dual RF™. Any
flammable fluid pooled under the patient or in the body depressions
should be mopped up prior to using the Surgitron
®
Dual RF™. Attention
should be called to the danger of ignition of endogenous gases.
NOTE: To ensure safe and reliable operation, the Surgitron
®
Dual/EMC unit
and relevant accessories should be checked for wear and tear before
operation.
A maintenance contract with the manufacturer or one of its authorized
service agents is recommended after the warranty period.
In the event of malfunction, the device must be returned or serviced by a
Cynosure-authorized technician for repair.