Professional Use Guide; Indications For Ob/Gyn Applications - CooperSurgical LEEP PRECISION LP-20-120 Manuel D'utilisation

• 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 .
• For monopolar systems it is recommended to keep the voltage/power as low as possible to achieve the
desired end effect (due to the potential for capacitive coupling and inadvertent burning at high voltages) .
• Adequate anesthesia is indicated for all electrosurgical procedures .
• Inspect loop and ball for adequate insulation .
• Avoid using an electric extension cord (danger of separation) .
• Use a smoke evacuator with this device .
• This device generates high frequency energy that could, under some circumstances, cause interference
to other equipment .
• For situations where the MAXIMUM OUTPUT VOLTAGE is less than or equal to 1600V, ASSOCIATED
EQUIPMENT and ACTIVE ACCESSORIES should be selected that have a RATED ACCESSORY
VOLTAGE equal to or greater than the MAXIMUM OUTPUT VOLTAGE .
- ASSOCIATED EQUIPMENT and ACTIVE accessories should be selected with RATED
ACCESSORY VOLTAGE ≥ MAXIMUM OUTPUT VOLTAGE when the smaller of variable y
(see below) or the number 6 is ≤ CREST FACTOR for that HF SURGICAL MODE.
- When MAXIMUM OUTPUT VOLTAGE (Umax) is > 1600 V, and the CREST FACTOR is < the
variable y calculated below, indicating that any ASSOCIATED EQUIPMENT and ACTIVE
ACCESSORIES used in such mode or setting must be rated to withstand the combination of actual
voltage andm CREST FACTOR .
U
max
y =
600 [Volts]
• No modification of this equipment is allowed .
• No customer-serviceable parts .
• Only replacment of power cords or fuses can be done by the user . Only replace with these items with
the exact replacement part(s) available from CooperSurgical .
Warning: To avoid risk of Electrical Shock, this equipment must only be connected to a supply mains with
protected earth .
Section 5 Professional Use Guide

5.1 Indications for OB/GYN Applications

• Cervical conization
• External anogenital lesion
• Large vaginal intraepithelial neoplastic (VAIN) lesions
• Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some
cervical intraepithelial neoplasias (CIN) and dysplasias
– 400 [Volts]
CAUTIONS
10