Encision EM3 Series EM3-20 Assembly instructions

EN
EM3 Monopolar Adapters
Instructions For Use/Care
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Device Description
Monopolar ESU Adapter
The EM3-XX Series Monopolar Adapter connects the EM3 AEM®
Monitor to an electrosurgical generator (ESU) and is a required
component of the AEM Monitoring System.
WARNING
• This product is not intended to be located in the sterile eld. It is
not supplied sterile.
CAUTION
• Steam sterilization will damage the device.
Indications/Intended Use
The Encision AEM Monitoring System is an accessory for use with
electrosurgical generators and electrodes that is designed to safely
deliver electrosurgical energy and to prevent injury caused by
insulation failure and capacitive coupling.
The AEM Monitoring System consists of two distinct functions:
• Active electrode monitoring is intended to control stray
monopolar energy caused by insulation failure and capacitive
coupling in surgical instruments on the shaft of the instrument.
• End point monitoring is intended to aid the surgeon in
determining the end point of bipolar electrosurgical desiccation.
Contraindications
There are no known contraindications for use of the AEM Monitor.
Instructions For Use
Prior to Use
Thoroughly read these instructions and the instructions in the EM3
AEM Monitor User’s Guide.
WARNING
• Explosion Hazard. Do not use electrosurgery in the presence of
ammable anesthetics.
• Electric Shock Hazard. Ensure that all accessories, cords, and
adapters are correctly connected and that no metal is exposed.
• Good operating room practice suggests that connections of
accessories to electrosurgical generators be made only while the
generator is o or on standby.
• 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
re hazard. Do not use product having damaged insulation.
• Do not attempt to connect or disconnect any cable during power
activation.
• Inspect cords for breaks, cracks, nicks, or other damage before
every use. Ensure that end of life indicators are not present. If any
of these are present, do not use. Failure to observe this precaution
may result in injury or electrical shock to the patient or operating
personnel.
• Pulling or tugging cords can result in breaking of internal
conductors, causing 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 re hazard.
• See electrosurgical generator manual and AEM Monitor User’s
Guide for precautions concerning the general application of
electrosurgical equipment.
Compatible Electrosurgical Generators
Manufacturer / ESU Model Monopolar Adapter
ConMed / System 5000™ EM3-40 or EM3-60
ConMed / Excalibur™ EM3-60
Covidien / Valleylab™ Force FX™ EM3-20 or EM3-60
Covidien / Force Triad™ EM3-70 or EM3-60
WARNING
• Electrosurgical generators included in the above list have been
tested for use with the EM3 AEM Monitor. Use of an untested ESU
may result in an inoperative active electrode monitoring system.
Contact Encision Customer Service for more information.
NOTE
• The Universal Monopolar Adapter, EM3-60, connects to all
electrosurgical generators compatible with the AEM Monitor.
Connecting the Monopolar Adapter
See the EM3 AEM Monitor User’s Guide or the Quick Setup Guide for
complete system setup.
1. Attach the Monopolar Adapter to the AEM Monitor using the
receptacle on the top of the monitor. Route the adapter cable to
either side of the monitor using the cable channel (optional).
Cable Channel
Cable Channel Monopolar Adapter
2. Place the AEM Monitor on a cart or attach it to a boom system.
3. Place the electrosurgical generator on top of the AEM Monitor or
in close proximity to the monitor to allow for connection of the
Monopolar Adapter to the ESU.
4. Attach the Monopolar Adapter to the ESU. The adapter connects
to the return electrode receptacle and a hand control accessory
receptacle of the ESU. For some ESUs, the adapter may also
connect to a foot control accessory receptacle. After properly
connecting the adapter, a secondary hand control accessory
receptacle on the ESU may be accessible for use.
Covidien Valleylab
Force FX ESU
with
EM3-20 Monopolar
Adapter, Force FX
Conmed
System 5000 ESU
with
EM3-40 Monopolar
Adapter, System 5000
Covidien
ForceTriad ESU
with
EM3-70 Monopolar
Adapter, Force Triad
ForceTriad™
AEM
®
Hand Control
Connector
ConMed
Excalibur ESU
with
EM3-60 Monopolar
Adapter, Universal
Hand
Control
Connector
Foot Control
Connector
Return Electrode
Connector
NOTE
• When using the Force Triad ESU, the monopolar hand control
connector of the adapter may be disconnected to allow usage
of an instrument without AEM technology. The AEM foot control
instrument is still available.

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EN
Disassembly
To remove the adapter from the AEM Monitor, pull the connector
away from the monitor.
To remove the adapter from the electrosurgical generator, pull the
connector body away from the ESU.
CAUTION
• Always disconnect adapter by pulling on connector body.
Replace adapter if intermittent electrical performance is
observed.
Reprocessing
Cleaning
Wipe down the exterior using a mild cleaning solution or disinfectant
and a damp cloth.
Use a cotton swab to clean the internal contacts of any
contaminates.
CAUTION
• Do not steam sterilize or immerse this product in any liquid. This
will damage the device.
NOTE
• Used instruments are considered medical waste. Dispose of in
accordance with local regulations.
Product Life
The life of this surgical instrument is largely dependent on the care
and handling at the point of use or cleaning. For optimal instrument
life, protect it from contact / impact with other instruments during
decontamination. The number of uses may be reduced by improper
handling.
End of Life Indicators
Visually inspect and electrically test prior to use. Discontinue use if
any of the following are evident:
• Connector: Bent, broken, loose, or missing components, or
corroded contacts. Damaged active contact (center post)
insulation (e.g. cracks, nicks, abrasions, holes, tears, burns or
melted areas).
• Cord: Damaged insulation (e.g. cracks, nicks, abrasions, holes,
tears, kinks, bulges, burns or melted areas). Pay special attention
to cord/connector interface. Manually ex the cable near the
connector ends. Increased exibility may indicate a conductor
wire break, even without obvious insulation damage.
• Electrical: Verify proper operation with the AEM Monitor and
electrosurgical generator; the adapter should be removed from
service if any malfunction occurs.
Express Warranty
ENCISION hereby warrants to Buyer that products purchased
hereunder shall be free from defects in materials and workmanship
under normal use and service, as specied in these Instructions for
Use/Care, for the period of six months from date of purchase, or
upon reaching an end of life indicator (including Maximum Number
of Uses), whichever occurs rst. Any evidence of unauthorized
modication or repair of this device will void the warranty.
See AEM Monitor Operator/Service Manual for details of Limitations,
Disclaimer, and Exclusions.
Return of Used Product
If for any reason this product must be returned to ENCISION,
a returned goods authorization is required prior to shipping.
Appropriate return instructions may be obtained from ENCISION.
Product
ENCISION reserves the right to amend, modify, or to change any
product, to introduce new products, to withdraw products and
otherwise vary product specications at any time without notice.
ENCISION® and AEM® are registered trademarks of ENCISION Inc.
All other referenced trademarks are owned by their respective
owners.
Federal (USA) law restricts this device to sale by
or on the order of a physician.
Consult Instructions for Use
Latex Free
Made in USA
Manufactured by
ENCISION Inc.
6797 Winchester Circle
Boulder, CO 80301 USA
Ph: 303-444-2600 Fax: [phone]
Authorized Representative
(according to MDD93/42/EEC
MDSS GmbH
Schigraben 41
30175 Hannover, Germany
Printed in USA
© Copyright 2012 Encision Inc.