EN
AEM® Cord
Instructions For Use/Care
00465-012 2010/12
1 of 4
ENCISION recommends placing this document in the Instructions for
Use/Care Section of your AEM® Monitor Operator/Service Manual.
Device Description
AEM Cord - Reposable
The
ES4007
AEM Cord connects the AEM Laparoscopic Instrument
to the AEM Monitor and electrosurgical generator, by means of the
ES9005 Cord Adapter.
The cord contains, in an insulated jacket, the conductors for the
active ESU current and AEM shielding and monitoring circuit.
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 instrument has been validated for 25 typical cycles
(including sterilization and use). The actual number of uses may
vary depending on usage conditions. Discard if any End of Life
Indicators are present.
•
This product is supplied non-sterile and must be sterilized prior
to use.
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.
(Note: Zone 1 equals Tip to Shield)
(Note: Zone 3 equals area of Trocar Cannula)
Zone 1
Zone 2
Zone 3
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 benefits of
the procedure.
Indications/Intended Use
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.
Contraindications
These instruments are not intended for use when laparoscopic
electrosurgical techniques are contraindicated.
Instructions For Use
Prior to Use
Thoroughly read these instructions and the instructions in the AEM
Monitor Operator/Service Manual.
Reusable components are supplied non-sterile. Refer to
Reprocessing Instructions prior to use.
Visually inspect cord for any potential issues. See End of Life
Indicators.
AEM System Setup
See laminated Setup Sheet (00701) when using the ES9005 series
AEM Cord Adapter and (02678) when using the ES9015 Universal
Adapter.
Connect one end of the cord to the laparoscopic instrument.
Connect the other end of the cord to the ES9005 Cord Adapter,
which connects the electrosurgical generator and the AEM Monitor
together for use with the cord. Electrically inspect cord for potential
issues. See End of Life Indicators.
AEM Cord Adapter
AEM Monitor
AEM Cord
Electrosurgical Generator
Footswitch Jack
CAUTION
•
Always fully connect AEM cord to instrument and adapter. Partial
connections may cause arcing, which will damage the product.
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.
•
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.
•
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 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.
Disassembly/Disposal
Always disconnect cord by pulling on connector body. Replace cord
if intermittent alarms are experienced during use or set up.
