Intended Use; Contraindications - Cooper Surgical Fischer Cone Biopsy Excisor 900-150 Mode D'emploi

Fischer Cone Biopsy Excisor
•
The Fischer Cone Biopsy Excisors
discard of in accordance with all applicable Federal, State and local
Medical/Hazardous waste products.

INTENDED USE

This product is intended for the removal of a conical cervical specimen.
INDICATIONS
•
Large Loop Excision Of The Transformation Zone (LLETZ) in the
diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN)
and dysplasias.
•
Diagnostic Usages (Electroexcision):
• Intraepithelial neoplasia of lower genital tract
• Condylomata acuminata
• Lesions such as polyps, molluscum, contagiosum, nevi, seborrheic
keratosis, achricordon, etc.
•
Therapeutic Usages (Electrofulguration):
• Intraepithelial neoplasia of lower genital tract
• Condylomata acuminata
• Symptomatic conservative treatment-resistant ectropion
• Lesions such as polyps, molluscum, contagiosum, nevi, seborrheic
keratosis, achricordon, etc.

CONTRAINDICATIONS

•
Absolute contraindication include hypovolemic shock, cardiac
decompensation (Class IV) and coagulapathy/blood dyscrasia;
acute/chronic severe, active infection caused by Herpes, Chlamydia or
Gonococcus and other aerobic and anaerobic organisms; intraepitheal
disease extending to or close to lower uterine segment; severe allergic
reaction to local anesthetic and iodine solutions; and a refusal to sign an
informed consent form
•
Relative contraindications include clinically apparent invasive cancer
(punch biopsy is sufficient for histologic diagnosis); pregnancy (except in
expert hands when invasion is suspected); less than 3 months post-
partum and hypoplastic DES-cervix
CAUTION: THE INSULATION ON THE ELECTRODE MAY BREAKDOWN AT
OUTPUT VOLTAGES ABOVE 6 kV. DO NOT ALLOW THE
ELECTROSURGICAL UNIT OUTPUT TO EXCEED 6 kV.
INSTRUCTIONS FOR USE
1. Use the appropriate electrosurgical precautions, coated insulated
instruments, dispersing pad, smoke and suction tubing.
• Instructions for Use • English (
®
are for single-use ONLY. After use,
®
4
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