2
I.
INTRODUCTION
1.0
INTRODUCTION TO RADIOSURGERY
®
Radiosurgery
®
with Ellman’s Surgitron
®
4.0 Dual RF™/90 IEC system (Surgitron
®
Dual/EMC) is an excellent method of cutting and coagulating soft tissue. With five
waveforms (4 monopolar and 1 bipolar) and a wide selection of electrode tips, the user can
easily configure the system for a wide array of applications.
1.1
INTENDED USE
The intended use for the Surgitron
®
Dual/EMC is:
1.1.1
Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty
(RAUP), myringotomy with effective hemorrhage control, epistaxis treatment,
turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, development
of skin flaps, skin tags and blepharoplasty.
1.1.2
Blended cutting and coagulation: snoring, submucosal palatal shrinkage, traditional
uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control,
epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis,
verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cysts, abscesses, and
development of skin flaps.
1.1.3
Hemostasis: control of bleeding, epilation, telangiectasia.
1.1.4
Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae,
hemostasis.
1.1.5
Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry),
snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP),
myringotomy with effective hemorrhage control, epistaxis treatment and turbinate
shrinkage.
NOTE: The Surgitron
®
Dual/EMC generator is not designed to withstand the
demands of lengthy wrinkle treatment procedures. The generator will overheat and
possibly fail. Such failures will not be covered by warranty.
II.
SAFETY
Improper use of this, or any high frequency surgical instrument, can result in a patient injury.
Read and become familiar with all directions before using this product.
2.0
WARNINGS
2.0.1
High frequency surgical equipment should be used only by persons having
adequate training and familiarity with high frequency surgical equipment and
related techniques. A thorough understanding of the use of high frequency surgical
equipment is essential to avoid shock and burn hazards to both patient and
medical personnel and damage to the device or other medical equipment. Consult
medical literature relative to related techniques, complications, and hazards prior
to use of high frequency surgical equipment.
2.0.2
Never increase the power settings without first checking both the active electrode
and the neutral plate.
2.0.3
Ocular Shields (plastic, non-conductive) must be used for any radiofrequency
surgical procedure involving the eyelid and the immediate surrounding areas.
2.0.4
Use only with Ellman accessories including Ellman handpieces, neutral plates,
cables
, and
electrodes.
2.0.5
When using an active electrode near a metal (conductive) accessory, ensure the
electrode does not come into contact with the metal accessory.
2.0.6
Failure of high frequency surgical equipment could result in an unintended
increase of output power.
2.0.7
Use a compatible neutral electrode with a contact quality monitor to ensure the
auditory alarm will sound in the event of loss of safe contact between the neutral
electrode and patient.
2.0.8
Risks resulting from neuromuscular stimulation can occur, especially with modes
producing electrical arcs between active electrode and tissue.
2.0.9
Do not maintain or service equipment while in use. Maintaining or servicing
equipment while in use may result in possible injury to the operator or patient.
