FMX Ferromagnetic Surgical System
4
Warnings
Read all instructions before use.
Use ONLY FMX surgical instruments with the FMX Generator.
DO NOT reuse, re-sterilize or reprocess “Single Use
Only” labeled accessories. Reuse of “Single Use
Only” devices risks cross-contamination of substances,
viable bacteria, and viruses between patients.
DO NOT use in the presence of flammable liquids, gasses
or materials. DO NOT activate the handpiece until vapors
from alcohol-based skin prep agents have dissipated.
Flammable agents used for cleaning or disinfecting, or as solvents of
adhesives, should be allowed to evaporate before the application of
high frequency surgery. There is a risk of pooling of flammable solutions
under the patient or in body depressions such as the umbilicus, and in
body cavities such as the vagina. Any fluid pooled in these areas should
be mopped up before high frequency surgical equipment is used.
Attention should be called to the danger of ignition of endogenous
gases. Some materials, for example cotton and gauze, when
saturated with oxygen may be ignited by heat produced in
normal use of the high frequency surgical equipment.
Be sure to allow sufficient time for surgical tip to
return to ambient temperature to avoid unintended
burns to patient tissue or the surgical staff.
DO NOT place the instruments on the patient drape. The tip can
remain hot after deactivation and can potentially melt through the
drape. Placement of the instrument on a wet, sterile towel when not in
use will prevent the possibility of melting the drape if the tip remains
hot or if the instrument is inadvertently activated with the foot pedal.
DO NOT inadvertently press the foot pedal. In order
to prevent the instrument from being unintentionally
activated, place the foot pedal in a location necessitating
deliberate action in order to activate the generator.
DO NOT bend the tip of the surgical instruments. Care
should be taken not to deliberately bend the tip as damage
will prevent proper function of the handpiece.
Only the surgeon using the instrument should operate the foot pedal.
Unintentional activation may occur if the foot pedal is activated
by a separate user, which may result in patient or user injury.
Smoke generated during surgical procedures can be irritating and
potentially harmful to surgical personnel. It is recommended to use
surgical masks and adequate ventilation or evacuation of smoke.
ELECTRICAL SHOCK HAZARD: Do not remove the cover of the
FMX Generator. Refer to authorized personnel for service.
To allow for proper cooling, the generator should not be
placed in an enclosed area while in operation. Appropriate
cooling is necessary to avoid overheating of the generator.
The power cord supplied should be connected to a properly
grounded receptacle. Extension cords and/or adapter plugs
should not be used. If necessary, the potential equalization
terminal may be used to establish electrical equipotentiality
with the grounding bus bar of the electrical installation or with
other equipment (per the requirements of IEC 60601-1).
Interference produced by the operation of the FMX Generator may
adversely influence the operation of other electronic equipment.
Operating room staff should never contact the
surgical tip while the generator is activated or while
the tip is cooling down, as injury may result.
When high frequency 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. Needle monitoring electrodes are
not recommended. In all cases, monitoring systems incorporating
high frequency current limiting devices are recommended.
Avoid contact with implanted electrical lead wires. The protective
thermoplastic insulation on some wires may melt at high temperatures.
DO NOT clean the tip of the surgical instrument
with an abrasive pad or metal instrument.
Failure of the FMX Generator could result in an
unintended increase of output power.
Ensure that the sound volume on the generator is adequately
adjusted so that the activation tones can be clearly heard. The
activation tone is intended to alert the user that the device
is active. This will help to prevent unintended activation of
the device, which could result in patient or user injury.
Ensure that the LCD touchscreen display and audio speaker are
functioning when turning on the generator. Several audible beeps should
be heard during the start-up process, and a splash screen will be displayed.
Ensure that all power cords and connector cables are properly
organized and placed so as to not create a tripping hazard.
No modification of this equipment is allowed.
Covers or access panels are to be removed
only by authorized service personnel.
Front Panel Layout
LCD Touchscreen
Display
Connection Port
Front Panel
Power Button
Rear Panel Layout
Foot Pedal
Connection
Ground Lug
Mains Power Cord
Connection
Rear Panel Power Button
Summary of Contents for FMX
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