Encision ES9015 Instructions For Use & Care

AEM® Universal Adapter
Instructions For Use/Care
EN
ENCISION recommends placing this document in the Instructions for
Use/Care Section of your AEM Monitor Operator/Service Manual.
Device Description
AEM Universal Adapter
The ES9015 Universal Adapter is intended to be used only with
Encision's AEM Monitoring System. The Universal Adapter provides
interface between the AEM Handswitching Handpiece (ES1300
series), the AEM Cord (ES4007 or ES4107) for footswitching
instruments, the AEM Monitor, and compatible electrosurgical
generators.
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 not intended to be located in the sterile field. It is
not supplied sterile. Steam sterilization will damage the 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 Tip to Shield)
(Note: Zone 3 equals area of Trocar Cannula)
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.
02677-003 2010/12
Indications/Intended Use
This accessory is for AEM instruments which are electrosurgical
cutting and coagulation accessories intended to remove tissue and
control bleeding by use of high-frequency electrical current.
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.
Inspect the instrument for proper assembly and function.
AEM System Setup
See laminated Setup Sheet (00701) when using the ES9005 series
AEM Cord Adapter and (02678) when using the ES9015 Universal
Adapter.
See laminated Troubleshooting Guide (02678) for additional
information.
WArNINg
• 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.
• 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.
• 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.
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