Encision AEM e-Edge Series Instructions For Use

AEM® Disposable Scissors Insert
EN Instructions For Use/Care
ENCISION recommends placing this document in the Instructions for
Use/Care Section of your AEM Monitor Operator/Service Manual.

Device Description

Disposable Scissors Insert – For Single Use Only
The Scissors Inserts are designed for use with the ES8000 / ES8200
series AEM® Handle Assemblies. The 1/2" curved scissors will fi t
through "true 5mm" surgical trocars and operating scopes. The 3/4"
scissors and hook scissors will fi t through standard 5.5mm trocars.

Principle of Operation

The AEM Handle Assembly is sized to accept an insulating
Disposable Sheath (ES0150 series) that allows the surgeon to control
the amount of exposed electrosurgically active metal at the scissors.
The front and rear handles open and close the working tip (blade
insert) of the instrument.
Scissors Insert Rotation Knob
Shielded Barrel Assembly
(Insert Inside)
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 Operation/Service Manual for list of
compatible electrosurgical generators.
 See also Instructions for Use/Care for AEM Instruments,
Disposable Sheath and Disposable Scissors as applicable.
 This product is supplied sterile and is not intended for use more
than one time. No attempt should be made to reprocess this
device.
00555-013 Rev. S 2015/04

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 fi eld 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
(Note: Zone 1 equals approximately 1.6cm Tip to Shield)
(Note: Zone 3 equals area of Trocar Cannula)
Cord Connection
Laparoscopic procedures should be performed only by surgeons
having adequate training and familiarity with laparoscopic
techniques and who are also knowledgeable about anatomy and
pathology as well as the complications, hazards, risks and benefi ts of
the procedure.

Indications/Intended Use

Handle
Trigger
These AEM instruments incorporate the use of AEM technology and
are intended for use in delivering monopolar electrosurgical energy
during laparoscopic procedures only.
AEM instruments are intended for use with the AEM Monitoring
System and electrosurgical generators having compatibility with the
AEM Monitor.
Scissors Inserts are intended for use on soft tissue only.

Contraindications

These instruments are not intended for use when laparoscopic
electrosurgical techniques are contraindicated.
Zone 2 Zone 3
Instructions For Use

Prior to Use

Thoroughly read these instructions and the instructions in the AEM
Monitor Operator/Service Manual.
The Disposable Scissors Insert is 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
insuffl ation of gas into the abdomen.
 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
fi re 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.
 Use these instruments only in conditions that assure adequate
visualization to minimize risk of misapplied electrosurgical
energy.
 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 fi eld 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.
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