Use the lowest output setting necessary to achieve the desired treatment
effect. The higher RF energy is applied, the greater the possibility of unintended
thermal damage.
When BodyTite and physiological monitoring EQUIPMENT are used
simultaneously on the same patient; any monitoring electrodes should be
placed as far as possible from the handpiece electrodes. Needle monitoring
electrodes are not recommended.
Failure of the equipment could result in an unintended increase of output
power.
The cables of the Handpiece should be positioned in such a way that contact
with the patient or other leads is avoided.
Fire / Explosion Hazard - The following substances will contribute to increased
fire and explosion hazards in the operating room:
– Flammable substances (such as alcohol based skin prepping agents and
tinctures).
– Naturally-occurring flammable gases which may accumulate in body cavities
such as the bowel.
– Oxygen enriched atmospheres.
– Oxidizing agents (such as nitrous oxide [N2O] atmospheres).
– Endogenous gases.
– The RF energy and heating associated with the System can provide an
ignition source. Observe fire precautions at all times. When using BodyTite
in the same room with any of these substances or gases, prevent their
accumulation or pooling within the area where BodyTite procedures are
performed.
The operation of BodyTite may adversely influence the operation of other
electronic EQUIPMENT.
To avoid the RISK of electric shock, this equipment must only be connected to a
SUPPLY MAINS with protective earth.
Do not use BodyTite on patients with pacemakers or internal defibrillators.