EN
AEM® Disposable Handpiece and AEM® Disposable Electrodes
Instructions For Use/Care
00282-006 2010/09
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ENCISION recommends placing this document in the Instructions for
Use/Care Section of your AEM Monitor Operator/Service Manual.
Device Description
Disposable Handpiece - For Single Use Only
The ES1300 series AEM® Disposable Handpiece is intended to be
used only with Encision’s AEM Disposable Electrodes.
Disposable Electrodes - For Single Use Only
The ES03XX series AEM® Disposable Electrodes are intended to be
used only with Encision’s ES1300 series AEM Disposable Handle.
The ES03XX series Electrodes are 5mm instruments designed to fit
commonly used Trocar Cannulas. The ES03XX series are also sized for
use with the Disposable Sheath.
Principle of Operation
The Handpiece provides switching for the CUT and COAG functions
of the ESU. The distal yellow button is CUT. The proximal blue button
is COAG.
NOTE
•
This product is rated to 9000 Vp-p. Limit electrosurgical generator
power setting to 80 Watts or lower (60 Watts for the Conmed
Aspen Excalibur spray mode). Higher settings may result in
spurious insulation failure alarms and/or insulation breakdown.
See Encision AEM Monitor Operator/Service Manual for list of
compatible electrosurgical generators.
•
This product is supplied sterile and is not intended for use more
than one time. No attempt should be made to reprocess this
device.
Use with Monopolar Electrosurgery
AEM instruments, in conjunction with an AEM Monitor properly
connected to the electrosurgical generator (ESU), continuously
monitor and dynamically manage “stray energy” (insulation failure
and capacitive coupling) in zones 2 & 3, which are likely out of the
surgeon’s field of view.
AEM shielding does not cover zone 1, which the surgeon should
keep in view during instrument activation. As in all applications,
“misapplied” electrosurgical energy remains the responsibility of the
attending surgeon.
Zone 1
Zone 2
Zone 3
(Note: Zone 1 equals approximately 2.5cm Tip to Shield)
Electrosurgical procedures should be performed only by surgeons
having adequate training and familiarity with these techniques and
who are also knowledgeable about anatomy and pathology as well
as the complications, hazards, risks and benefits of the procedure.
Indications/Intended Use
The AEM Disposable Handpiece and AEM Disposable Electrodes
are electrosurgical accessories intended, by use of monopolar
high-frequency electrical current from compatible electrosurgical
generators, for ablation, removal, resection and coagulation of soft
tissue where associated hemostasis is required in open, endoscopic
and laparoscopic surgical procedures.
The devices are intended for use by qualified medical personnel
trained in the use of electrosurgical equipment.
AEM instruments incorporate the use of AEM technology and
are intended for use with the AEM Monitoring System and
electrosurgical generators having compatibility with the AEM
Monitor.
Contraindications
These instruments are not intended for use when electrosurgical
techniques are contraindicated.
Instructions For Use
Prior to Use
Thoroughly read these instructions and the instructions in the AEM
Monitor Operator/Service Manual.
The Disposable Handpiece and Disposable Electrodes are supplied
sterile. Inspect the package and product for damage prior to use.
AEM System Setup
See laminated Setup Sheet (00701) when using the ES9005 series
AEM Cord Adapter and (02678) when using the ES9015 Universal
Adapter.
WArNINg
•
Laparoscopic surgery may result in gas embolism due to
insufflation of gas into the abdomen.
•
Pulling or tugging cords can result in breaking of internal
conductors, causing intermittent alarms or sparking and burning
of insulation during use. The AEM Monitor is not designed to
detect or prevent an arc in the event of a broken active wire.
•
Damage to connector body and/or insulation may result in shock
or fire hazard.
•
Keep electrical connections dry while in use to prevent potential
conduction of HF current to the user.
•
Damaged external insulation AND incorrect setup of the AEM
Monitor may result in a risk of unintended patient burn, shock or
fire hazard. Do not use product having damaged insulation.
CAUTION
•
Good operating room practice suggests that connections of
accessories to electrosurgical generators be made only while the
generator is OFF or on Standby.
•
Avoid buildup of eschar on the tip insulation which can provide
a conductive path for HF energy when in proximity to tissue - by
either:
- Use of the Disposable Sheath (preferable), or
- Frequent cleaning of the tip to remove eschar.
•
Use these instruments only in conditions that assure adequate
visualization to minimize risk of misapplied electrosurgical
energy.
•
Do not activate the ESU if the monitor’s green Ready light is
off. No Ready light means there is a setup error or equipment
malfunction.
•
Keep ESU power setting as low as possible for the intended
purpose to minimize unintended burns.
•
Damaged internal insulation of the cord and/or instrument,
or loss of shield continuity, may cause ESU return pad alarms
triggered by the AEM Monitor’s Fault Indicators. For maximum
patient safety, discontinue use of the instrument if this occurs.
•
A singular AEM instrument must be the sole conductor of energy
to tissue. Do not conduct energy by touching an AEM instrument
to a second instrument contacting tissue. The second device will
not be protected from capacitive coupling and insulation failure.
•
Keep electrosurgical instruments away from the patient and
operative field when not in use. Accidental activation can result in
unintended injury to the patient.
•
See electrosurgical generator manual and AEM Monitor
Operator/Service Manual for precautions concerning the general
application of electrosurgical equipment.
Assembly Instructions
The ES03XX series AEM Disposable Electrodes are designed to be
used only with the ES1300 series AEM Disposable Handpiece.
1. Grasping the rotation knob of the Disposable Electrode, insert it
into the Handpiece until it snaps or clicks into place. When fully
seated, the rotation knob should not rotate.
Insert Electrode into Handpiece
