Boston Scientific RF 3000 Gebrauchsanweisung Seite 3

RF 3000™ Radio FRequency GeneRatoR
CAUTION! Federal (USA) law restricts this device to be used
by or under the direction of a physician.
intRoduction
The RF 3000 Radio Frequency (RF) Generator is intended for thermal
coagulation of soft tissue with electrodes separately cleared by the United
States FDA. The generator delivers an isolated RF output of up to 200 watts to
the electrode. Full power is available in the impedance range of 25Ω to 100Ω at
a constant RF voltage; lower powers are available outside this range. Power can
be adjusted manually; however, changes in load impedance will change the actual
power delivered (a safety feature described more fully in "Passive Power Limitation").
When power is on, actual delivered RF power and impedance are displayed.
The Operation and Service Manual is intended as an instructional guide only.
GeneRal PRoceduRe SaFety
WARNING! Safe and effective electrosurgery is dependent not only on equipment
design, but also, to a large extent, on factors under the control of the operator.
It is important that the instructions supplied, both with this equipment and the accessories,
be read, understood, and followed in order to ensure safety and effectiveness.
WARNING! No modification of this equipment is allowed
WARNING! The use of RF energy can produce unintended neuromuscular
stimulation. Appropriate precautions, including the use of lower power
settings and continuous monitoring of the patient during treatment, should be
taken to minimize the risk of patient injury.
CAUTION! The safety of electrosurgery will be greatly enhanced by a thorough knowledge
of the medical literature on the subject. Study of specific information on the hazards
and complications of the procedure in question is especially recommended.
CAUTION! Whenever practical, the patient should not be allowed to come into
contact with electrically conductive parts that are earth grounded or have an
appreciable capacitance to earth (for example supports, etc.). The use of antistatic
sheeting is recommended for this purpose.
CAUTION! The risk of igniting flammable gases or other materials is inherent in
electrosurgery and cannot be eliminated by device design. Precautions must be
taken to avoid contact of flammable materials and substances with electrosurgical
electrodes. Flammable agents used for cleaning or disinfecting, or as solvents of
adhesives, should be allowed to evaporate before the application of HF surgery.
CAUTION FOR MAGNETIC RESONANCE (MR) IMAGING! The RF 3000 Generator is not
MR compatible and should be kept outside the shielded MR scan room. In addition,
the RF Generator emits signals that may interfere with MR imaging. Therefore, the
Generator should be "OFF" when the MR scanner is acquiring image data.
CAUTION! Apparent low output or failure of the RF 3000 Generator to function
correctly at the normal operating setting may indicate faulty application of the electrode
or poor contact in its connections. In this case, the application of the electrode and
its connections should be checked before selecting a higher output power.
CAUTION! Skin-to-skin contact (for example between the arms and body of the
patient) should be avoided. Insertion of dry gauze between the skin contact areas
is recommended.
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