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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3
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.)
4
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5
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.)
6
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7
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
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9
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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• Microprocessor controlled for increased precision accuracy repeatability and safety.
• Adequate power for all LEEP monopolar electrosurgical procedures.
• Accurate selection of discrete power levels.
• Digital display of output power levels.
• Choice of radio frequency wave forms including CUT BLEND and COAG to
accommodate subtle differences in technique and accessory performance.
• Patient plate continuity monitoring with audible alarm.
• Distinct audible tones for CUT/BLEND modes and COAG mode with associat-
ed MODE light.
• Fully regulated isolated output power.
• Meets or exceeds IEC 601-2-2 second edition.
• Non-electric pneumatic foot pedal to maximize safety.
• Choice of reusable or disposable patient plate.
• Choice of reusable or disposable handpiece.
• Choice of reusable or disposable electrodes.
• Output power safety audible alarm with automatic power shut off.
• Class 1 type BF protected for use with defibrillator.
• Membrane switching to maximize cleanliness and ease of use.
CONTROLS
1. Main switch
2. Socket for pedal switch
3. Socket for active electrodes
4. Socket for neutral electrode
5. Warning light of neutral
electrode alarm (red)
6. Coagulation light (blue)
7. Pure cut and blend light (yellow)
8. Mode control:
9. Power control
II. SYSTEM FEATURES
1 2 9 3 4
765
Pur Cut
Bl nd Cut
Coag
10
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Classification I Type BF protected against defibrillator effects
Floating output circuit
Cautions consult this manual for safety precautions
Pedal connection
Active handle connection
Patient plate connection
High voltage
Specifications: Meets or exceeds IEC 601-1 IEC 601-1-2 and IEC 601-2-2
specifications. Meets the requirements of Annex I of Directive 93/42/EEC
relating to Medical Devices.
ELECTRICAL
INPUT VOLTAGE: 95 - 135 VAC 50/60 Hz 190 - 250 VAC 50 Hz
CURRENT: 2.3 amps max. 2.3 amps max.
LOW FREQUENCY LEAKAGE: Less than 50 micro-amps Less than 50 micro-amps
FUSES: 2.5 amps T type 1.6 amps T type
POWER CORD: American Cord Set Hospital Grade
NEMA 5-15P/IEC 320 Female 250cm Long
PHYSICAL
Dimensions: 305mm x 267mm x 115mm Weight: 7.250 Kg
ELECTROSURGICAL OUTPUT
RF Output Frequency: 450 kHz
RF OUTPUT POWER: Volts p-p Max Duty Crest
(open circuit) Cycle Factor
CUT 0-100 watts RMS* 830 --- 1.4
BLEND 0-100 watts RMS* 1200 60% 2.0
COAG 0-80 watts RMS* 3800 10% 5.5
NOTE: *Stable to >800 ohms (calibration at 500 ohms)
RF ISOLATION: Less than 150 milli-amps at 200 ohms
CLASSIFICATION . . . . . . . . . .I-Type BF
OUTPUT CIRCUIT . . . . . . . . .Floating output. Protected against the effects
of the defibrillator.
WORKING MODE . . . . . . . . .Discontinuous maximum duty cycle: 10/30 sec.
COOLING . . . . . . . . . . . . . .Convection cooling without fan
CONTROL . . . . . . . . . . . . . .Foot pedal operated (pneumatic) with audible
signals and mode lights
LEEP System 1000®• Operating Manual
11
II. SYSTEM FEATURES (cont.)
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AUDIBLE SIGNALS AND LIGHTS FOR OPERATION AND ALARM:
MAIN . . . . . . . . . . . . . . . . . . . . . . . . . . . . Green light
ALARM PATIENT PLATE CONTINUITY . . . . Low pitch intermittent audible alarm
- red light
ALARM OUTPUT POWER . . . . . . . . . . . . . Higher pitch intermittent audible alarm
CUT AND BLEND MODES . . . . . . . . . . . . . Low pitch audible signal - yellow light
COAGULATION MODE . . . . . . . . . . . . . . . High pitch audible signal - blue light
NOTE: Specifications subject to change.
OUTPUT POWER AT 500 OHMS
PURE CUT . . . . . . . . . .100 W RMS (open circuit 830 Vp-p; crest factor 1.43)
Waveform: sinusoidal at 450 KHz
BLEND CUT . . . . . . . . .100 W RMS (open circuit 1200 Vp-p; crest factor 2)
Waveform: sinusoidal at 450 KHz
Duty cycle: 60%
COAGULATION . . . . . .80 W RMS (open circuit 3800 Vp-p; crest factor 5.5)
Waveform: sinusoidal at 450 KHz
Duty cycle: 10%
Output Power Diagrams according to PAR.6.8.3 (IEC 601-2-2)
II. SYSTEM FEATURES (cont.)
100
75
50
25
25 50 75 100
Setting
Setting
POWER (500 ohm)
PURE CUT
BLEND CUT
80
60
40
20
20 40 60 80
COAGULATION
(W)
POWER (500 ohm)
(W)
12
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13
II. SYSTEM FEATURES (cont.)
LEEP System 1000®• Operating Manual
Power
2K1.9K1.8K1.7K1.6K1.5K1.4K1.3K1.2K1.1K1K900800700600500400300200100
Impedance
(ohm)
1 PURE CUT - POWER 100%
2 PURE CUT - POWER 50%
50
100
75
50
25
0
2K1.9K1.8K1.7K1.6K1.5K1.4K1.3K1.2K1.1K1K900800700600500400300200100
Impedance
(ohm)
1 BLEND CUT - POWER 100%
2 BLEND CUT - POWER 50%
50
100
75
50
25
0
2K1.9K1.8K1.7K1.6K1.5K1.4K1.3K1.2K1.1K1K900800700600500400300200100
Impedance
(ohm)
1 COAGULATION - POWER 100%
2 COAGULATION - POWER 50%
50
100
75
50
25
0
(W)
Power
(W)
Power
(W)
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Tolerance: 20% according to PAR.50.2 (IEC 601-2-2)
The safety and effectiveness of electrosurgery is dependent to a large degree
upon the skill of the user/operator. It is important that the user/operator read
understand and follow the operating instructions supplied with the
CooperSurgical LEEP System and thoroughly understand the principles
and use of radio frequency (RF) electrosurgical systems.
WARNING: Electrosurgery uses radio-frequency energy to cut and coagulate
tissue. Due to the sparking and heat associated with electrosurgery do not use
with flammable anesthetics or other flammable gases near flammable fluids or
objects or with oxidizing agents.
• DO NOT use electrosurgery in the presence of flammable gases flammable
liquids or flammable objects in oxygen enriched atmospheres nitrous oxide
(N20) atmosphere or in the presence of other oxidizing agents.
• Prevent accumulation of oxygen nitrous oxide (N20) and flammable gases
under surgical drapes or within the area where electrosurgery is performed
and it should be avoided in case of thorax or head operations unless safely
aspirated.
• Verify that all oxygen connections are leak-free before and during the
use of electrosurgery.
• DO NOT use electrosurgery in the presence of naturally occurring flammable
gases which may accumulate in body cavities such as the bowel.
DO NOT use electrosurgery in the presence of flammable liquids such as
skin prepping agents. Avoid pooling of flammable liquids near the electro-
surgery site or in human body cavities such as the umbilicus or vagina.
• DO NOT place the electrosurgery active electrode near or in contact with
flammable materials such as cotton wool or gauze. The active electrode
is hot from use and can cause fire.
• It is possible that the radio frequency can interfere with the electronic circuitry
in the pacemaker. To reduce the risk locate the patient return electrode as
close as possible to the treatment site and ensure that the current path
between the surgical site and the patient return electrode is as far removed
from the heart as possible. For the gynecology procedures locate the
patient return electrode on the patient's upper thigh or under buttocks.
Always monitor pac mak r pati nts during surg ry. In case
of doubt ask the pacemaker manufacturer and/or cardiology department.
• In case of loss of power turn the system off.
• The possibility exists that the radio frequency can interfere with other medical
equipment when the electrosurgical system is operating. To reduce the inter-
ference physically separate the device utilize different electrical outlets that
are hospital grounded do not allow cables to come in contact with each
other and utilize shielded devices where possible.
• The fixed output power level should be adjusted to the lowest power setting
that will successfully complete the procedure. Refer to the following recom-
mended power settings for the CooperSurgical LEEP System 1000®Electrodes.
III. ELECTROSURGICAL PRECAUTIONS
14
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15
The above power settings are for reference only and can be varied based on
specific situations and the experience of the operator.
NOTE: * If the cut mode is desired use the recommended settings for
the blend mode.
+ The power setting can be increased beyond 56 to coagulate
any bleeding points as required.
• Skin to skin contact for instance between the patient's arm and body should
be avoided by the placement of an appropriate separating device such as two
to three inches of dry gauze. This will reduce the potential for alternate site
burns.
• If monitoring stimulation imaging or similar devices are used simultaneously
with electrosurgery the monitoring electrodes must be placed as far as
possible from the electrosurgery site and the patient return electrode.
Position the patient return electrode close to the electrosurgery site for
example on the thigh when treating the cervix. NOTE: Monitoring needle
electrodes are not recommended.
• The electrical cord of the generator should be connected to a properly
grounded receptacle. Extension cords and/or adapter plugs should not be
used.
• The connecting cables to the electrosurgery electrodes should be placed so
that they do not come in contact with the patient other cables or cross each
other.
• Remove any metal items from the patient: for example rings chains etc.
• Use accessories supplied by CSI; they are specifically designed for the LEEP
System 1000®.
• Do not use old or worn accessories.
When using an electrosurgical system it is very important that all the current
delivered to the patient returns correctly to the unit via the dispersive patient
plate only.
• The patient must be positioned correctly on the operating table. The patient
and operator must not come in contact with any metal conductive surfaces.
III. ELECTROSURGICAL PRECAUTIONS (cont.)
LEEP System 1000®• Operating Manual
Recommended Power Settings (Watts)
for the CooperSurgical LEEP System 1000®Electrodes
IV. PLACEMENT OF THE PATIENT PLATE
OR DISPERSIVE ELECTRODE
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• The patient plate must securely contact a vascular area close to the operating
site. For a gynecology procedure the preferred sites are the patient's thigh
(disposable adhesive pads) or under the patient's buttocks (reusable metal
plate). The contact area must be clean free of body lotions shaved and
massaged for good circulation. The contact area of the patient plate must be
maximized and frequently checked for uniform contact during the procedure
especially if the patient has moved or if liquids have contacted the patient
plate. A CONDUCTIVE GEL IS RECOMMENDED. The patient plate MUST
NEVER be placed so as to allow the patient's heart to be in the pathway
from the active electrode.
• Power delivery to the operative site may be decreased appreciably if alternate
pathways exist; for example through the metal operating table crossed
handpiece/patient plate cables etc.
V. FOOT PEDAL SWITCH
Connect the foot pedal switch to the socket (2) without activating the pedal and
tighten the threaded plug.
This is an air (pneumatic) operated control. There is no electric current offering
maximum safety.
VI. POWER CONNECTION, ELECTRODE CONNECTION
AND APPLYING POWER TO UNIT
(Refer to Diagram on Page 10)
A. Check that power input corresponds to the technical data on the back of
the unit. Plug the power cord into the appropriate grounded wall outlet
ensuring that the ESU on/off switch is in the "OFF" position.
B. Connect dispersive patient plate to the socket (4).
C. Connect the active electrode handpiece to the socket (3) and tighten
electrode of choice in the handpiece.
D. Turn ON the unit by the power switch (1). The unit automatically performs a
SELF TEST that checks RAM memory EPROM memory supply voltage signal
modulation and the following displays; function selector green lights digital
display cut and coagulant yellow light coagulation blue light and the audible
signal. When the unit passes SELF TEST the display will show current software
revision i.e. r2A r2B for several seconds then goes blank.
IV. PLACEMENT OF THE PATIENT PLATE
OR DISPERSIVE ELECTRODE (cont.)
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VII. OPERATION
S tting Pow r (refer to diagram on Page 10)
A. Control (8) sets the cut mode power output. The unit automatically powers
up to cut mode when turned ON. Top LED lights on the selector (8) and
control (9) sets the power.
B. Control (8) selects blend mode (center LED) and control (9) sets the power.
C. Control (8) selects coagulation mode (bottom LED) and control (9) sets the
power.
Power settings are stored when the system is ON and will appear automatically
on the display of control (9) according to the selection of power mode by the
control (8) during the procedure.
Power may be changed at any time during the operation except when the unit
is activated by the foot pedal.
At the end of the procedure turn the system OFF and safely store the equipment
and accessories. Power will reset to zero.
VIII. SAFETY CIRCUITS
The LEEP System 1000®is equipped with two (2) safety circuits. The first one
checks the dispersive patient plate connection. The second one turns off the
power in case of an internal failure. When activating the unit by the foot pedal
a power delivery higher than the one selected will stop power delivery and at
the same time give an audible signal similar to the patient plate alarm but at
a higher frequency.
IX. PRACTICAL SUGGESTIONS
To optimize the performance when using an electrosurgical unit the active
electrode must be kept clean and use the lowest possible power setting required.
Some sparks or superficial carbonization of the tissue may occur and the delivered
power may decrease as a result of the electrical insulation caused by the tissue
charring.
Too high of a power setting results in a shorter surgical procedure but may
cause discharges and/or superficial carbonization sparking arcs etc.
X. CLEANING
The unit may be cleaned with mild soap solution but take great care that fluid
does not enter the system. Wipe dry.
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XI. PERIODIC SAFETY CHECKS
The following safety checks should be performed at least every 24 months by a
qualified person who has adequate training knowledge and practical experience
to perform these tests.
• Inspect the equipment and accessories for mechanical and functional
damage.
• Inspect the relevant safety labels for legibility.
• Inspect the fuse to verify compliance with rated current and breaking
characteristics.
• Inspect acoustical and visual alarms/displays.
• Verify that the device functions properly as described in the instructions
for use.
• Verify that the device shuts down the applied part circuit if the neutral
electrode is disconnected.
• Test the protection earth resistance according to IEC 601-1/1988:
Limit 0.2 ohm.
• Check that the output power is within tolerance versus the output control
setting at a specified load resistance.
• Check the power output at full and half setting of the output control over
the range of load resistance as specified in the instructions for use
(max. deviation is ± 20%).
• Test the enclosure leakage current according to IEC 601-1/1988:
Limit 100µA.
• Test the leakage current according to IEC 601-1/1988: Limit 100µA (BF).
• Test the patient leakage current under single fault condition with main
voltage on the applied part according to IEC 601-1/1988: Limit: 5mA (BF).
• Verify the continuous activation of the unit and the function of the Foot
Pedal. With the unit turned on and the Foot Pedal and a Patient Return Pad
connected press and hold the Foot Pedal for 60 seconds with the unit in any
mode (CUT BLEND or COAG). Both the LED and the audible indicators
should remain activated while the Foot Pedal is depressed and should
deactivate upon its release.
The leakage current should never exceed the limit. The data should be recorded
in an equipment log. If the device is not functioning properly or fails any of the
above tests the device has to be repaired.
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XII. TROUBLESHOOTING
In the event of a failure during SELF TEST the display will show one of the error
codes listed below:
ALARM SIGNALS
PROBLEM AUDIBLE TONE DISPLAY
RAM M mory 1 kHz 100ms On 250ms OFF “Er0”
(during s lf-t st phas )
EPROM M mory 1 kHz 100ms ON 250ms OFF “Er1”
(during s lf-t st phas )
Signal Modulation 1 kHz 200ms ON 250ms OFF “Er2”
(during s lf-t st phas )
Signal Modulation 1 kHz 40ms ON 60ms OFF “Er2”
(during activation phas )
Supply Voltag 1 kHz 100ms ON 250ms OFF “Er3”
(during s lf-t st phas )
Supply Voltag 1 kHz 40ms ON 60ms OFF “Er3”
(during activation phas )
Pow r Output 1 kHz 100ms ON 250ms OFF Er5
(during activation phas )
Foot P dal Circuit 1 kHz 100ms ON 250ms OFF Er6
(during s lf-t st phas )
Microcontroll r Pow r Supply 1 kHz 100ms ON 250ms OFF Er7
Disp rsiv El ctrod 1 kHz 80ms ON 125ms OFF “nP”
& Red Light
A. If upon completion of Self Test the unit display reads Er0 Er1 Er2 Er3 Er5
Er6 or Er7 the unit must be returned to your local Distributor for repair (see
page 1).
B. If upon completion of Self Test or if the unit stops functioning and the display
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