Cooper Surgical Fischer Cone Biopsy Excisor 900-150 Mode D'emploi page 5

Fischer Cone Biopsy Excisor
CAUTION
•
U.S. Federal law restricts this device to sale by or on the order of a physician.
•
This device SHOULD NOT be used without proper training and
preceptorship.
•
Sterile unless package has been opened or damaged. Ethylene Oxide gas
sterilized.
•
THE INSULATION ON THE ELECTRODE MAY BREAKDOWN AT
OUTPUT VOLTAGES ABOVE 6 kV. DO NOT ALLOW THE
ELECTROSURGICAL UNIT OUTPUT TO EXCEED 6 kV.
PRECAUTIONS
•
LEEP is a powerful surgical procedure with occasional intra-operative and
post-operative complications. You MUST obtain informed signed consent
prior to the procedure.
•
Severe bleeding may rarely develop after deep excisional procedures and
may be difficult to impossible to control by direct pressure, electro-
fulguration and application of AstrinGyn
have the appropriate instruments for suturing blood vessels in the office.
•
Adequate anesthesia and complete visualization of the lesional area
should be obtained before initiating LEEP.
•
Use only speciality-designed insulated instruments for performing LEEP
procedures, to avoid burns to patient or physician.
•
For maximum safety, the vaginal walls may be protected from activated
excisor and inadvertent cuts and burns by a latex condom placed on any
of the LEEP specula. The use of condoms or LEEP vaginal retractor
F400H) is of great help to retract vaginal walls allowing for good
visualization of the cervix and vagainal fornix. Check first for patient
allergy to latex before using condoms.
•
Prior to any cone electrosurgical procedures, make a "dry pass" with the
excisor under colposcopic guidance. This will determine that the path of
the activated excisor will not be obstructed or come in contact with non-
insulated or anesthetized tissue.
•
Electrosurgical excision with cone excisor must be relatively slow but
continuous.
•
To increase good visualization during LEEP, it is necessary to have an
adequate fume evacuation vacuum-suction system. Make sure it
functions properly before initiating LEEP.
•
Make sure that the electrosurgical unit (ESU) is maintained in the "Stand-
by" mode until electrosurgery begins.
•
Physicians with limited experience with LEEP will obtain a stable hand by
placing the shaft of the cone excisor on the posterior blade of the LEEP
speculum.
• Instructions for Use • English (
®
gel or Monsel's paste. You must
®
3
)
continued