00282-006 2010/09
2 of 2
EN
2. To rotate the tip/shaft, push the rotation knob forward
approximately 1mm until it stops. This allows rotation of the
electrode shaft.
Push forward
Approximately 1mm
3. Verify proper operation with the AEM Monitor and electrosurgical
generator. The instrument should be removed from service if any
malfunction occurs. Refer to “Checking the AEM Monitor” in the
AEM Monitor Operator/Service Manual.
4. Use a Disposable Sheath to fully cover the tip insulation, allowing
only the metal tip of the Electrode to be exposed, minimizing the
possibility of eschar buildup.
5. To remove the Disposable Electrode, apply inward pressure on
the rotation knob at the 2 gripping points and pull the electrode
out of the Handpiece.
Pull electrode out
Apply inward pressure to grips
Apply inward pressure to grips
6. An electrode may be removed and replaced in the Handpiece as
necessary during a single procedure.
End of Life Indicators
Discontinue use if any of the following are evident:
•
Intermittent electrical performance
•
Bent electrode shaft or tip affecting function of sheath or
insertion into trocar
•
Bent or damaged housing, rod or tip
•
Any insulation damage which exposes metal (AEM Shield)
along the length of the instrument’s shaft and/or any insulation
damage in Zone 1
•
After one use of product.
reprocessing
This product is intended for single use and shall not be reprocessed
or resterilized. Resterilization may compromise the integrity of the
device, which may result in malfunction.
NOTE
•
Used instruments are considered medical waste. Dispose of in
accordance with local regulations.
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 specified in this Instruction for Use/
Care, until the labeled USE BY date, or one (1) use, whichever occurs
first.
Any evidence of repair, modification, or resterilization of this product
will void this 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 specifications at any time without notice.
US Patent No.: D566,836
ENCISION® and AEM® are registered trademarks of ENCISION Inc.
Federal (USA) law restricts this device to sale
by or on the order of a physician.
Consult Instructions for Use
Latex Free
Do not use if the product sterilization barrier
or its packaging is compromised.
Hand Activated
Made in Taiwan
Manufactured for
ENCISION Inc.
6797 Winchester Circle
Boulder, CO 80301 USA
Ph: 303-444-2600
Fax: 303-444-2693
Authorized representative
(according to MDD93/42/EEC
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Printed in Taiwan
© Copyright 2010 Encision Inc.
