Welch Allyn Electrosurgical Unit User Manual

Operating Manual

Electrosurgical Unit

Operating Manual

Electrosurgical Unit • Instruction Manual

1

Electrosurgical System

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

Manufactured for:

Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153

Phone: [phone]
Phone: [phone]
Fax: [phone]

IMPORTANT

Thoroughly train the user of this equipment, in the techniques of loop electrosurgi­cal excision procedures. This equipment is designed for use with Electrosurgical
Accessories. DO NOT use this equipment for any purpose other than that for which
it is 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 actual procedure is performed, nor is it meant to
teach the proper technique or any of the medical considerations regarding the use
of this equipment. Welch Allyn recommends that prospective user obtain appropri­ate training before using this equipment as improper use is potentially hazardous to
the patient and the user. DO NOT use this device 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.

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.

FOLLOW INSTRUCTIONS CONTAINED IN THE OPERATING MANUALS OF ANY
EQUIPMENT USED IN CONJUNCTION WITH THIS EQUIPMENT 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.

ALWAYS EXERCISE SAFETY PRECAUTIONS 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 or Welch Allyn Customer Service at 1-800-535-6663.

I. PROFESSIONAL USE GUIDE

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Electrosurgical Unit • Instruction Manual

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A. INDICATIONS

The loop electrosurgical excision 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 loop electrosurgical
excision procedure. It is imperative that the physician carefully weigh 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 is
not visualized colposcopically

• less than 3 months postpartum

• DES-exposed patient with known or suspected cervical changes

• equivocal cervical abnormality

C. LOOP ELECTROSURGICAL EXCISION PROCEDURE PROCEDURE AND TECHNIQUE

It is recommended that the patient is provided with a brief description of the pro­cedure and the equipment is used in this procedure (ACOG and other professional
organizations and equipment manufacturers have produced patient information
brochures on the loop electrosurgical excision procedure that address many of the
questions and concerns that your patients may have regarding the procedure).

D. SAFETY PRECAUTIONS

1. Only a thoroughly trained physician should use this equipment in an adequately
equipped medical facility.

2. Keep replacement accessories and patient return pads on hand since defective
active accessory or patient return pads can result in sub-standard performance
of this equipment.

Electrosurgical Unit • Instruction Manual

I. PROFESSIONAL USE GUIDE (cont.)

PROPER

Generator

RF current through

patient to return pad

Active Electrode

Grounded

Metal Case

Patient

Two conductor patient

electrode continuity

monitor

Patient return pad

(Thigh)

Patient may be

grounded

3. Only connect this equipment to a properly grounded receptacle. NEVER use an
adapter that defeats the ground of the built-in three (3) prong plug.

4. Exercise care 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. Never use this equipment in conjunction with other equipment for which safe­ty against leakage current is not established.

6. When this equipment is operated:

a. Use a properly attached Patient Return Pad (dispersive pad) of adequate sur-

face area to the patient or the risk of accidental burns will exist.

b. Place the Patient Return Pad (dispersive pad) as close as possible to the site

of use of the active accessory but NEVER placed so that the patient’s heart
is in the pathway from the active accessory to the return electrode!

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.

I. PROFESSIONAL USE GUIDE (cont.)

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8. Follow the instructions for use described in this manual; otherwise, compro­mised safety, malfunction, injury to the operator and/or patient, or costly dam­age to the unit may occur.

9. There are no user-serviceable parts within the housing. Only authorized Welch
Allyn service personnel can perform repairs to this equipment. For service
information, please contact Welch Allyn Customer Service at 1-800-535-6663.

I. PROFESSIONAL USE GUIDE (cont.)

Electrosurgical Unit • Instruction Manual

IMPROPER

Generator

Burn occurs at small

grounded contact

Surgeon touches electrode

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 current returns to patient

return pad via ground path

EKG

RF

RF

EKG

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 determine
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. Ensure every effort is made 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 is applied.

I. PROFESSIONAL USE GUIDE (cont.)

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Electrosurgical Unit • Instruction 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 Welch Allyn Electrodes is recom­mended.

I. PROFESSIONAL USE GUIDE (cont.)

Electrosurgical Unit • Instruction Manual