Professional Use Guide; Leep Precision Cart Use; Indications - Cooper Surgical LEEP PRECISION LP-10-120 Manual De Funcionamiento

Section 5 Professional Use Guide
This manual contains information about the proper procedures for inspecting and preparing the LEEP PRECISION
Generator before its use as well as for its care and storage after use .
This manual does not describe how an actual procedure is to be performed, nor is it meant to teach a
beginner the proper technique or any of the medical considerations regarding the use of this equipment .
CooperSurgical strongly recommends that the prospective user obtain appropriate training before using
this equipment, as improper use could be potentially hazardous to the patient and the user .
This device SHOULD NOT be used without proper training.
Training in the use of electrosurgical equipment should include:
1. A review of the published literature regarding the procedure of interest
2. Attendance at a course or courses offered by physicians experienced with the Loop
Electrosurgical Excision Procedure
3. Hands-on preceptor training from an experienced practitioner
Read this entire manual carefully to become familiar with each of the controls and features before
making any attempt to use the equipment clinically.
Instructions contained in the operating manuals of any equipment to be used in conjunction with this
equipment must be followed to avoid any possible hazard from incompatibility .
Failure to thoroughly understand and follow the instructions given in this manual may result in serious injury
to the patient and/or the operator . Failure to follow the instructions given in this manual may result in damage to
or malfunction of this equipment .
No long-term follow-up studies as to recurrence rates with this device have been performed . The effects of
Loop Electrosurgical Excision Procedure on pregnancy outcome are not known .
SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO
PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD, AND EQUIPMENT DAMAGE.
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 .
If any questions arise regarding the information contained in this manual, the operation, or safety of the
equipment or service, please contact CooperSurgical .

5.1 LEEP PRECISION Cart Use

VERY IMPORTANT: The LEEP PRECISION Integrated System must only be moved by grasping and
holding firmly onto the LEEP PRECISION Cart Handles to ensure the Cart does not tip over .
The LEEP PRECISION Cart must only be pushed or pulled using the handles on the front of the
LEEP PRECISION Cart to ensure stability during transportation .

5.2 Indications

•
Cervical conization
•
Large Loop excision of the transformation zone (LLETZ) in the diagnosis and treatment of some cervical
intraepitherial neoplasias (CIN) and dysplasias
•
External anogenital lesion
•
Large vaginal intraepithelial neoplastic (VAIN) lesions
14