Cooper Surgical LEEP System 1000 User manual

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LEEP System 1000®• Operating Manual
1
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: [phone]
Phone: [phone]
Fax: [phone]
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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
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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.)
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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
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.)
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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.)
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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
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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.)
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