Cooper Surgical LEEP System 1000 Manuel utilisateur

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LEEP System 1000®• Operating Manual

LEEP System 1000®

TABLE OF CONTENTS

I. Professional Use Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2

II. System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

III. Electrical Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

IV. Placement of the Patient Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

V. Foot Pedal Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

VI. Power Connection Electrode Connection & Power-Up . . . . . . . . . . . . . . . .16

VII. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

VIII. Safety Circuits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

IX. Practical Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

X. Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

XI. Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

XII. Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

XIII. Liability Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

XIV. Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

XV. Explanation of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Manufactur d by:

CooperSurgical Inc.

95 Corporate Drive

Trumbull CT 06611

Phone: 203-601-5200

Phone: 800-243-2974

Fax: 800-262-0105

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IMPORTANT

The user of this equipment LEEP System 1000® should be thoroughly trained in

the techniques of Loop Electrosurgical Excision Procedures. This equipment has

been designed for use with LEEP Electrosurgical Accessories. DO NOT use this

equipment for any purpose other than that for which it has been designed.

This manual contains information about the proper procedures for inspecting

and preparing the equipment before its use and 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 recommends

that 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. A review of the Loop Electrosurgical Excision Procedure (LEEP) Syllabus

available from CooperSurgical.

3. Attendance at a course or courses offered by Physicians experienced

with the Loop Electrosurgical Excision Procedure.

4. Hands-on preceptor training from an experienced practitioner.

Please 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 with this device have been performed as to

recurrence rates. 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 your local

Distributor.

I. PROFESSIONAL USE GUIDE

LEEP System 1000®• Operating Manual

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A. INDICATIONS

The LEEP procedure is indicated in the diagnosis and treatment of some Cervical

Intraepithelial Neoplasia (CIN) in patients where there is:

• Cytological or colposcopic suspicion of CIN 2 or worse (including micro-invasion)

• Persistent CIN 1 (of more than 12 months duration)

• CIN 1 where the likelihood of follow-up is low or when the patient requests

treatment

• A transformation zone which is fully visible and fully confined to the cervix

• A suspicion (cytological or colposcopic) of a glandular intraepithelial abnormality

• A disparity between the cytological and colposcopic diagnoses

• External anogenital lesion

• large vaginal intraepithelial neoplastic (VAIN) lesions

• Cervical conization indications

B. CONTRAINDICATIONS

The following are typical contraindications for performing the LEEP procedure.

It is imperative that the physician carefully weight the risks and benefits of

treatment versus non-treatment in contraindicated patients:

• Pregnancy

• Apparent invasive carcinoma of the cervix

• A bleeding disorder

• Acute or active inflammation of the cervix endometrium fallopian tube

ovary or peritoneum (cervicitis endometritis tubo-ovarian inflammatory

disease or pelvic inflammatory disease)

• “Positive” endocervical curettage or a lesion in which the endocervical limit

cannot be visualized colposcopically

• Less than 3 months postpartum

• DES-exposed patient with known or suspected cervical changes

• equivocal cervical abnormality

C. LEEP PROCEDURE AND TECHNIQUE

It is recommended that the patient be provided with a brief description of the

procedure and the equipment that will be used (ACOG CooperSurgical and

other professional organizations and equipment manufacturers have produced

patient information brochures on the LEEP procedure that address many of the

questions and concerns that your patients may have regarding the procedure).

D. SAFETY PRECAUTIONS

1. This equipment should only be used by a thoroughly trained physician in an

adequately equipped medical facility.

LEEP System 1000®• Operating Manual

I. PROFESSIONAL USE GUIDE (cont.)

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PROPER

Generator RF current through

patient to return pad Active Electrode

Grounded

Metal Case

Patient

To conductor patient

electrode continuity

monitor

Patient return pad

(Thigh)

Patient may be

grounded

2. Replacement accessories and patient return pads should be kept on hand

since defective active accessory or patient return pads can result in sub-

standard performance of this equipment.

3. This equipment should only be connected to a properly grounded receptacle.

NEVER use an adapter that defeats the ground of the built-in three (3) prong

plug.

4. Care must be exercised when handling liquids around electrical equipment.

DO NOT attempt to operate this equipment if liquids have spilled on the unit.

DO NOT use flammable liquids around electrical equipment.

5. This equipment should never be used in conjunction with other equipment

for which safety against leakage current has not been established.

6. When this equipment is operated:

a. A Patient Return Pad (dispersive pad) of adequate surface area MUST

be properly attached to the patient or the risk of accidental burns will

exist.

b. The Patient Return Pad (dispersive pad) should be placed as close as

possible to the site of use of the active accessory but MUST NEVER be

placed so as to allow the patient’s heart to be in the pathway from

the active accessory to the return electrode!

I. PROFESSIONAL USE GUIDE (cont.)

LEEP System 1000®• Operating Manual

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7. The user should thoroughly understand the principles and use of radio

frequency (RF) current before using this equipment. This understanding is

essential to avoid the hazard of shocks or burns to the user and/or the

patient.

8. The instructions for use described in this manual must be followed; other-

wise compromised safety malfunction injury to the operator and/or patient

or costly damage to the unit may occur.

I. PROFESSIONAL USE GUIDE (cont.)

LEEP System 1000®• Operating Manual

IMPROPER

Generator Burn occurs at small

grounded contact

Surgeon touches electode

to grounded object

Isolated

ESU

RF current flows from ground

through EKG pad through

patient to return pad

IMPROPER

Generator RF current flows

from electrode

Burn occurs at small

grounded contact

Isolated or

grounded ESU

Patient return pad touches

grounded table

RF curent returns to patient

return pad via ground path

EKG

RF EKG

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9. There are no user-serviceable parts within the housing. Repairs to this

equipment should only be performed by authorized CooperSurgical service

personnel. For service information please contact your local Distributor

(see page 1).

E. ELECTROSURGICAL PROCEDURES

This section provides only general information about the use of electrosurgical devices.

Only the User can evaluate the clinical factors involved with each patient and deter-

mine if the use of this equipment is indicated. The User must then decide on the

specific technique and procedure that will accomplish the desired clinical effect.

WARNING

Electrosurgical generators are designed to allow the controlled destruction

of tissue and are inherently dangerous if operated improperly.

REPORTED PROBLEMS DUE TO IMPROPER OPERATION DURING

ELECTROSURGICAL PROCEDURES HAVE INCLUDED:

Inadvertent activation with resultant tissue damage at the wrong site

and/or equipment damage.

Alternate current pathways resulting in burns where the patient or

physician or assistant is in contact with exposed metal.

Explosions caused by electrosurgical sparking in a flammable gas mixture

(i.e. explosive anesthetic gases and the inappropriate use of alcohol and

other flammable liquids).

Perforation and massive hemorrhage.

A proper patient return pad pathway is extremely important during any

monopolar electrosurgical procedure. Every effort must be made to

ensure that throughout the electrosurgical procedure an adequate

surface area is provided and remains in proper contact with the patient

to reduce the current density below a level that might cause inadvertent

tissue damage where the patient return pad has been applied.

I. PROFESSIONAL USE GUIDE (cont.)

LEEP System 1000®• Operating Manual

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1. SETTING THE CONTROLS

A. Electrosurgical Tissue Effect

Delivery of continuous sinusoid waveform currents through a small

electrode at appropriate power levels can cause rapid heating of the

intracellular fluids in the cells in close proximity to the electrode turning

these fluids to steam. The significant increase in volume (approximately

5 times) causes cellular structure to rupture creating the clinical effect of

“CUT” with little or no hemostatic effect along the margin of the divided

tissue. Delivery of short duration pulses of RF currents through a small

electrode at appropriate power levels can cause heating of intracellular

fluids at a more gradual pace. This allows evaporation of these fluids

without rupturing the cellular structure creating the clinical effect of

desiccation or “COAG” without the division of tissue. By varying the

pulse to an intermediate duration it is possible to get a clinical effect

that combines or “blends” the clinical characteristics of CUT and COAG

yielding the effect referred to as “BLEND” where tissue is divided with a

desirable amount of hemostatis along the margins of the divided tissue.

The electrosurgical effect may vary throughout the procedure requiring

the operator to adjust the relative power setting of the generator.

B. Select the output mode (i.e. “CUT” “BLEND” or “COAG”) by pushing the

corresponding buttons.

Output Mode Waveform Description General Effect

CUT Continuous 450 KHz sinusoid Cutting without Hemostatis

with minimal modulation

BLEND Interrupted 450 KHz sinusoid Cutting with minimal

intermediate duty cycle Hemostatis

COAG Bursts of 450 KHz sinusoid Coagulation without Cutting

short duty cycle

c. Set the level of output power (confirmed on the digital display) by using

the output power selector buttons as desired.

WARNING

The degree and speed of electrosurgical effect is largely dependent on

Current Density at the point of contact of the active electrode. Loop

electrosurgical excision procedure electrodes from other manufacturers

may vary in the diameter thickness size and configuration of the cutting

wire. This may result in SIGNIFICANT changes in the electrosurgical effect

at a given output power level setting. The use of CooperSurgical LEEP

Electrodes is recommended.

I. PROFESSIONAL USE GUIDE (cont.)

LEEP System 1000®• Operating Manual

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d. If the use of other output modes is anticipated repeat steps #1 and #2 as

desired. The output power level settings selected for each output mode

will be retained as long as the unit remains ON.

2. GUIDELINES FOR POWER SETTINGS

The following guidelines for power settings may vary due to the technique

clinical circumstances accessory style cutting wire diameter size

configuration and user preference.

REMEMBER, THIS IS NOT AN ATTEMPT TO TEACH ELECTROSURGICAL TECHNIQUE.

The practitioner who lacks experience should not attempt the procedures

described below based solely on this information; instead the skills required

should be acquired in the time-honored preceptor manner. Call your local

Distributor (see page 1) for information on courses that still offer instruction on

the proper use of electrosurgical generators and accessories.

NOTE: The best initial effect is accomplished with the cutting wire in only light

contact with tissue. Tight pressure may cause desiccation of the tissue and will

delay the start of the cutting effect.

IMPORTANT

The initial use of any electrosurgical generator always involves some degree

of “trial and error”. This is true even when only changing from numbered

dials to digital display models within the same manufacturer’s product line.

As with any other therapeutic device it is very helpful to experiment IN

VITRO or on animal sample tissue before using any electrosurgical genera-

tor or methods which are not familiar.

The microprocessor control system of this unit was developed specifically to

provide the best possible performance for loop electrosurgical excision pro-

cedures. By exhibiting patience and following the guidelines offered the

practitioner should easily become familiar with the performance character-

istics of the LEEP System 1000®.

I. PROFESSIONAL USE GUIDE (cont.)

Recommended Power Settings (Watts)

for the CooperSurgical LEEP System 1000®Electrodes

LEEP System 1000®• Operating Manual

34-46

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3. TECHNIQUE GUIDANCE

a. When performing the procedure the endocervix is commonly not

included in the loop excision and the results of endocervical curettage

do not appear to be predictive of either residual or invasive disease after

Loop Electrosurgical Excision Procedure.

b. Loop Electrosurgical Excision Procedures performed with small diameter

wire loop electrodes may produce multiple small pieces of cervical tissue

and provide a less acceptable tissue specimen for histopathologic analysis.

The influence of electrode design on procedure effectiveness is not

completely understood.

c. Larger lesions involving multiple quadrants of the cervix are more difficult

to remove with either the small or large diameter loop electrodes.

4. SMALL DIAMETER LOOP VS. LARGE DIAMETER LOOP

The histological quality of specimens obtained using small diameter loop

electrodes may be inferior to specimens obtained using large diameter loops

due to the increase contact area between loop and tissue epithelium. While

the design of the LEEP electrodes has been chosen to optimize specimen

quality operative technique must take these differences into consideration.

Reports of clinical evaluations of small diameter loop electrodes describe

thermal damage which precluded histological evaluation of approximately

3% of the tissue specimens. In addition since multiple often irregular strips

of epithelium are excised from the cervix it is often difficult for the pathologist

to orient the specimens for optimal histopathological examination.

5. THERMAL EFFECTS ON TISSUE TREATED WITH LOOP ELECTRODES

Thermal effects on tissue specimens may include (1) thermal coagulation

injury of the cervix up to one-third the thickness of normal epithelium of the

cervix (2) fragmentation of squamous epithelium of the cervix attributable to

long exposure periods along the excision site that allows heat to dissipate lat-

erally and (3) partial coagulation of the endocervical epithelium because of

lateral radiation of heat. Therefore the loop electrosurgical excision procedure

(LEEP) may produce thermal effects at the periphery of the excised tissue and

may make histopathologic interpretation difficult or impossible and not allow

accurate diagnosis and need for further treatment.

I. PROFESSIONAL USE GUIDE (cont.)

LEEP System 1000®• Operating Manual

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