ConMed ExcaliburPLUS PC - Page 10

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use of a medical device. Serious injuries ог Ш-
ness involving the use of a medical device
must be reported to the manufacturer of the
device (or to the FDA if the manufacturer of
the device is not known) within 10 working
days of the incident. Summary reports of
such injuries must also be submitted directly
to the FDA twice a year. Patient deaths relat-
ed to the use of a medical device must be
reported to the manufacturer and the FDA.
For further information, please contact the
Regulatory Affairs Department of CONMED
Corporation at 800-552-0138, 303-699-7600,
or FAX 303-699-9854.
* A failure of the unit could result in an unin-
tended increase in output power.
* Safe and effective electrosurgery is depen-
dent not only on equipment design, but also
on factors under the control of the operator.
It is important that the instructions supplied
with this equipment be read, understood, and
followed in order to ensure safety and effec-
tive use of the equipment.
* Do not use monopolar electrosurgery on
small appendages, as in circumcision or finger
surgery, as it can cause thrombosis and other
unintended injury to tissue proximal to the
surgical site. Please note ANSI/AAMI
Standard HF-18-1993 which currently con-
traindicates both monopolar and bipolar elec-
trosurgery for circumcisions.
Urologic literature also contraindicates the use
of monopolar electrosurgery for circumcision,
and instead recommends the use of bipolar
electrosurgery where clinically indicated for
hemostasis. Physicians choosing to use bipo-
lar electrosurgery for circumcisions should be
trained in this technique and knowledgeable
of the effects of electrosurgery on tissue of
this nature.
Should you decide that the bipolar electrosur-
gical technique is acceptable for circumcision,
do not apply the bipolar electrosurgical cur-
rent directly to circumcision clamps.
* Apparent low power output or failure of the
electrosurgical equipment to provide the
expected effect at otherwise normal settings
may indicate faulty application of the return
electrode, failure of an electrical lead, or exces-
sive accumulation of tissue on the active elec-
trode. Do not increase power output before
checking for obvious defects or misapplica-
tion. Check for effective contact of the return
electrode to the patient anytime that the
patient is moved after initial application of the
return electrode.
* Studies have shown that smoke generated
during electrosurgical procedures may be
harmful to surgical personnel. These studies
recommend using a surgical mask and ade-
quate ventilation of the smoke using a surgical
smoke evacuator or other means.
* If a Dual Pad RETURN Alarm is sounded
intraoperatively, physically confirm proper
return electrode attachment to the patient
prior to pressing the Monitor Set key. Smooth
hand over pad surface to ensure electrode con-
tact to patient skin. Replace the pad, if neces-
sary.
* Simultaneous activation can be used in both
Standard and Spray monopolar coagulation
modes. Caution should be used as the output
from either active electrode may change as a
result of: activation of a second output, end-
ing activation of an output, or changing the
arc length from an output. Power sharing is
unlikely to be equal because of differences in
tip to tissue distance and other factors. This
unequal power sharing can be enough to stop
power delivery to one tip if the second tip is
close to tissue, and the first tip is somewhat
above the tissue. The motion or deactivation
of one electrode can cause the other electrode
to start delivering power when it had been too
far away from tissue to arc before the first
electrode change. It is recommended that a
second electrosurgical generator be used as a
better alternative when it is necessary to per-
form simultaneous operation.
* Electrosurgical leads (active, bipolar or
return) should not be allowed to contact the
patient, staff, or other electrical leads connect-
ed to the patient.
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