Product Manual

When using Blend mode, associated equipment and active accessories should be selected that
have a rated accessory voltage equal to or greater than 1870 Vpeak max.
When using Coagulation mode, associated equipment and active accessories should be selected
that have a rated accessory voltage equal to or greater than 4000 Vpeak max.
When using Bipolar mode, associated equipment and active accessories should be selected that
have a rated accessory voltage equal to or greater than 600 Vpeak max.
Use electrosurgery with caution in the presence of internal or external devices such as
pacemakers or pulse generators. Interference produced by the use of electrosurgical devices can
cause devices such as pacemakers to enter an asynchronous mode or can block the
pacemaker effect entirely. Consult the device manufacturer or hospital Cardiology Department for
further information when use of electrosurgical appliances is planned for patients with
cardiac pacemakers or other implantable devices.
If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for
instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple acti-
vation of ICDs.
The entire area of neutral electrode should be reliably attached to patient's body and as close to
operating field as possible. Refer to instructions for use.
The PATIENT should not come into contact with metal parts which are earthed or which have an
appreciable capacitance to earth (for example operating table supports, etc.).
Do not use electrosurgical equipment unless properly trained to use it in the specific procedure
being undertaken. Use by physicians without such training has resulted in serious, unintended
patient injury, including bowel perforation and unintended, irreversible tissue necrosis.
For surgical procedures where the high frequency current could flow through parts of the body hav-
ing a relatively small cross-sectional area, the use of bipolar techniques may be desirable to avoid
unwanted coagulation.
In some circumstances, potential exists for alternate site burns at points of skin contact (e.g.,
between the arm and the side of the body). This occurs when electrosurgical current seeks a path to
the return electrode that includes the skin-to-skin contact point. Current passing through small skin-
to-skin contact points is concentrated and may cause a burn. This is true for grounded, ground ref-
erenced, and isolated output generators.
When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used
simultaneously on the same PATIENT, any monitoring electrodes should be placed as far as
possible from the surgical electrodes.
To reduce the potential for alternate site burns, do one or more of the following:
• Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient.
• Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does
not occur.
• Position the return electrode to provide a direct current route between the surgical site and
the return electrode which avoids skin-to-skin contact areas.
• In addition, place patient return electrodes according to the manufacturer’s instructions.
Potential for alternate site burns increases if the return electrode is compromised. Bovie Medical
Corporation recommends the use of split return electrodes and Bovie® generators with a contact
quality monitoring system.
Do not wrap the accessory cords or return electrode cords around metal objects. This may induce
currents that could lead to shocks, fires, or injury to the patient or surgical team.
The PATIENT leads should be positioned in such a way that contact with the PATIENT or other
leads is avoided.
Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and
tissue occur. The generator has been designed to minimize the possibility of neuromuscular
stimulation.
Accessories must be connected to the proper receptacle type. In particular, bipolar accessories
must be connected to the Bipolar Instrument output jack only. Improper connection may result in
unsafe generator power output.
For all Monopolar modes, any associated equipment and active electrodes must be rated to with
stand the combination of output voltage, vp-p and crest factor as stated in Appendix A of this
manual.
1-4 Bovie Medical Corporation