ConMed ExcaliburPLUS PC - Usage Cautions

E + +++
ble. In general, electrosurgical current paths
should be as short as possible and should run
either longitudinally or in a diagonal direction
to the body, not laterally and under no cir-
cumstances lateral to the thorax.
+ Electrodes and probes of monitoring, stimu-
lating, and imaging devices can provide paths
for high frequency currents even if they are
battery powered, insulated, or isolated at
50/60 Hz. The risk of burns can be reduced.
but not eliminated by placing the electrodes of
probes as far away as possible from the elec-
trosurgical site and the return electrode.
Protective impedances incorporated in the
monitoring leads may further reduce the risk
of these burns. Needles should not be used as
monitoring electrodes during electrosurgical
procedures.
* When high frequency surgical equipment
and physiological monitoring equipment is
used simultaneously on the same patient, any
monitoring electrodes should be placed as far
as possible from the surgical electrodes.
Needle monitoring electrodes are not recom-
mended. In all cases, monitoring systems
incorporating high frequency current limiting
devices are recommended.
* The active electrode should not be used in
the vicinity of electrocardiograph electrodes.
* Heat applied by thermal blankets or other
sources is cumulative with the heat produced
at the return electrode (caused by electrosurgi-
cal currents). Risk of a patient injury may be
minimized by choosing a dispersive electrode
site that is remote from other heat sources.
+ When using injection cannulas as electrocar-
diograph electrodes, the metal cone must not
be placed on the skin; this also applies to the
leads to monitoring instruments.
* Electrosurgery by it's nature produces signif-
icant levels of electromagnetic interference
(EMI) when the ESU is activated. This EMI
may damage or impair the function of other
electronic equipment in the O.R., especially
that which makes contact with the patient.
Adverse effects can be mitigated by use only of
equipment specifically designed to tolerate
electrosurgical interference. Cables subject to
flexing should be inspected frequently for
shielding integrity.
* The patient should not be allowed to come
into contact with metal parts that are ground-
ed, or have an appreciable capacitance to
earth. Examples of this would be operating
tables, supports, etc. The use of anti-static
sheeting is recommended. It is recognized
that this recommendation may not be practical
during certain procedures (e.g., those in which
uninsulated head frames are used); however,
to maximize patient safety during the use of
electrosurgical devices, such practices should
be minimized.
* Skin to skin contacts, such as between the
arm and the body of a patient, should be
avoided, by the insertion of dry gauze.
* The use of electrosurgery on patients with
cardiac pacemakers, pacemaker electrodes, or
other active implants is potentially hazardous.
The pacemaker may be irreparably damaged
and/or the high frequency energy of the elec-
trosurgical output may interfere with the
action of the pacemaker. Ventricular fibrilla-
tion may occur.
Precautions should be taken to ensure that the
patient's well-being is maintained in the event
of such interference. We recommend that the
Cardiology Department and the manufacturer
of the pacemaker be consulted for advice
before operating on a patient with a pacemak-
er. These precautions also apply to operating
room personnel with cardiac pacemakers.
+ To minimize the possibility of cardiac pace-
maker interference, place the return electrode
such that the electrosurgical current path is as
far as possible from the pacer lead.
1.1.3 CAUTIONS For Use
* PLEASE NOTE: Effective November 29,
1991, federal law (U.S.A.) requires that all
healthcare facilities must report to the manu-
facturer of a medical device, any death or seri-
ous injury or illness to a patient related to the