IM-LIPOTOWER Rev G
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WARNING:
EFT (Electromagnetic environment – guidance): Mains power quality should be that of a typical
commercial or hospital environment. If EFT-related issues are experienced during use, the use of power-line filtering
may be necessary to ensure proper operation in the presence of large power-line transients.
WARNING:
Do not block cooling vents. Maintain 50mm MIN clearance.
CAUTION:
This device is designed to contour the body by removing localized deposits of excess fat through small
incisions and subsequently transfer the tissue back to the patient.
CAUTION:
Do not leave cannulas in patient when not in use.
CAUTION:
Use of this device is limited to those physicians who, by means of formal professional training or sanctioned
continuing medical education (including supervised operative experience), have attained proficiency in suction
lipoplasty and tissue transfer.
CAUTION:
Results of this procedure will vary depending on patient age, surgical site and experience of the physician.
CAUTION:
Results of this procedure may or may not be permanent.
CAUTION:
The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect.
CAUTION:
All reusable components of the device must be sterilized and all disposable components replaced before
using the device system on another patient.
CAUTION:
Federal Law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner).
CAUTION:
See “PAL-650 Instrument System Instruction Manual” for detailed information on the PAL-650 handpiece.
CAUTION:
See “Model 1020 Standard Electric Console Instruction Manual” for detailed information on the Model 1020
Standard Electric Console. See “Model 5020 Standard Electric Console Instruction Manual” for detailed information on
the Model 5020 Standard Electric Console.
CAUTION:
Do not use this device to aspirate surgical smoke from devices such as cauterizers, lasers, electrosurgical
instruments or ultrasonic units. Doing so may clog the biofilter.
NOTE:
This device is intended only for the aspiration of tissue or fluid from the body. The tissue product collected by
this device shall only be used with FDA exempt/cleared/approved devices for any further use other than disposal.
NOTE:
All personnel involved with the operation, cleaning, maintenance and cleaning of the REF ASP-1020, -1021,
should become familiar with the power equipment before it is set up for use in any procedure. Personnel that are
trained should include, but not be limited to, central processing personnel, members of the surgical team, and the
bioengineering department.
NOTE:
The MicroAire LipoTower System should only be used with compatible FDA cleared tubing, handpieces and
cannulas.
NOTE:
The MicroAire LipoTower System has been tested for sound level and does not exceed 70 dB(A).
Содержание ASP-1021
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