ConMed SYSTEM 5000 - Cautions for Use

1-4
ence. Cables subject to flexing should be
inspected frequently for shielding integrity.
• Other equipment in the operating room,
including portable or mobile communica-
tions equipment, may produce EMI, which
can affect the function of the ESU. Adverse
effects can only be mitigated by use of equip
-
ment with EMI characteristics proven below
recognized limits. In the event of suspected
interference from other equipment, discon
-
tinue use of the ESU until the problem can be
remedied.
• The patient should not be allowed to come
into contact with metal items that are ground
-
ed or have an appreciable capacitance to earth.
Examples of this would be operating tables,
supports, etc.
• Jewelry and other metallic items can cause
localized burns if they make contact with
grounded items and should be removed from
the patient prior to use of electrosurgery.
• Skin to skin contacts, such as between the arm
and body of a patient or between the legs and
thighs, should be avoided by the insertion of
dry gauze.
• The use of electrosurgery on patients with
cardiac pacemakers, AICDs, neurostimulators
or other active implants is potentially hazard
-
ous. The implant may be irreparably dam
-
aged and/or the high frequency energy of the
electrosurgical output may interfere with the
function of the implant. Ventricular fibrilla
-
tion may occur. Precautions should be taken
to ensure the patient’s well-being is main
-
tained in the event of such interaction. The
manufacturers of the implants should be con
-
sulted for advice before operating on a patient
with an implant. These precautions also apply
to operating room personnel with similar
implants.
• To minimize the possibility of cardiac pace
-
maker interference, place the dispersive elec
-
trode such that the electrosurgical current
path does not intersect the path of the pace
-
maker or leads.
1.1.3 Cautions For Use
• Safe and effective electrosurgery is dependent
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 safe and effective
use of the equipment. Only properly quali
-
fied and trained operators should perform
electrosurgery. The operator and their sup
-
port personnel must be diligent in assuring
that the ESU is properly configured and that
proper settings are used. The ESU must be
located to assure the operator or their support
personnel can readily verify the settings.
• PLEASE NOTE: Federal law (U.S.A.)
requires that all health care facilities must
report to the manufacturer of a medical
device, any death or serious injury or illness
to a patient related to the use of a medical
device. Serious injuries or illness 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 inci
-
dent. Summary reports of such injuries must
also be submitted directly to the FDA twice
a year. Patient deaths related to the use of a
medical device must be reported to the manu
-
facturer and the FDA. For further informa
-
tion, please contact the Regulatory Affairs
Department of CONMED Electrosurgery at
800-552-0138, 303-699-7600 or FAX 303-
699-9854.
• Do not use monopolar electrosurgery on small
appendages, as in circumcision or finger sur
-
gery, as it can cause thrombosis and other
unintended injury to tissue proximal to the
surgical site. Should the surgeon decide that
the bipolar electrosurgical technique is accept
-
able for circumcision, do not apply the bipolar
electrosurgical current 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 disper
-
sive electrode, failure of an electrical lead or
excessive accumulation of tissue on the active
electrode. Do not increase power output
before checking for obvious defects or misap
-
plication of the dispersive electrode. Check
for effective contact of the dispersive electrode
to the patient anytime the patient is moved
after initial application of the dispersive elec
-
trode.