Cooper Surgical LEEP PRECISION LP-10-120 User manual

Operating Manual (English)
Bedienungsanleitung (Deutsch / German)
Manual de funcionamiento (Español / Spanish)
Manuel d’utilisation (Français / French)
Manuale di funzionamento (Italiano / Italian)
Manual de funcionamento (Português / Portuguese)
操作手册 (简体中文 / Mandarin Chinese)
LEEP PRECISIONTM Integrated System
120 VAC Model LP-10-120
230 VAC Model LP-10-220

English ...................................... Page 3
Deutsch / German............................. Seite 41
Español / Spanish............................Página 79
Français / French ............................ Page 117
Italiano / Italian .............................Pagina 155
Português / Portuguese ......................Página 193
简体中文 / Mandarin Chinese ...................页码 231

3
LEEP PRECISIONTM Integrated System, 120 VAC and 230 VAC
Models LP-10-120 and LP-10-220
Table of Contents
Section Content Page
1. Description ................................................................ 5
1.1 Introduction ................................................................. 5
1.2 LEEP PRECISION Generator Description ......................................... 5
1.3 LEEP PRECISION Smoke Evacuator Description ................................... 5
1.4 LEEP PRECISION Cart (with attached LEEP PRECISION Integration Unit) Description ..... 5
2. Unpacking and Assembly .................................................... 6
2.1 Unpacking Shipping Carton .................................................... 6
2.2 Unpacking and Installing the LEEP PRECISION Smoke Evacuator ..................... 7
2.3 Unpacking and Installing the LEEP PRECISION Generator ........................... 7
2.4 Installing the Filters and Tubing to the LEEP PRECISION Smoke Evacuator .............. 8
2.5 Connecting the LEEP PRECISION Integrated System to the Wall Outlet ................... 8
2.6 Installing the Foot Pedal Switch on the LEEP PRECISION Generator ................... 9
2.7 Installing the Active and Dispersive Electrodes ..................................... 9
3. LEEP PRECISION Generator Features ......................................... 11
4. Front and Rear Panels of the LEEP PRECISION Generator and Integration Unit ...... 12
4.1 Front Panel of the LEEP PRECISION Generator ................................... 12
4.2 Rear Panel of the LEEP PRECISION Generator ................................... 13
4.3 LEEP PRECISION Integration Unit ............................................. 13
5. Professional Use Guide ..................................................... 14
5.1 LEEP PRECISION Cart Use .................................................. 14
5.2 Indications ................................................................ 14
5.3 Contraindications ........................................................... 15
5.4 LEEP Procedure and Technique ............................................... 15
5.5 Safety Precautions .......................................................... 15
5.6 Electrosurgical Procedures .................................................... 16
6. Electrosurgical Precautions ................................................. 19
7. LEEP PRECISION Patient Return Electrode ................................... 21
8. Turning on the LEEP PRECISION Integrated System ............................. 22
8.1 Practice ................................................................... 22
8.2 The Power Setting .......................................................... 24
8.3 Cutting Techniques .......................................................... 24
8.4 Criteria of a Good Cutting Technique ............................................ 25
8.5 Coagulating ............................................................... 25
8.6 Coagulating Technique ....................................................... 25
8.7 Technique Guidance ........................................................ 26
9. Powering Down the LEEP PRECISION Integrated System ......................... 26
10. Maintenance .............................................................. 27
11. Accessories .............................................................. 27
11.1 Disposable Hand Switch Pencils ............................................... 27

4
Table of Contents (continued)
Section Content Page
12. Troubleshooting ........................................................... 28
13. Specications ............................................................. 29
13.1 LEEP PRECISION Integrated System ........................................... 29
13.2 LEEP PRECISION Generator ................................................. 29
13.3 LEEP PRECISION Smoke Evacuator ........................................... 30
13.4 LEEP PRECISION Cart with Integration Unit ...................................... 30
13.5 Power Output Characteristics .................................................. 31
13.6 Power Output at Various Load Resistance ........................................ 32
14. LEEP PRECISION Smoke Evacuator .......................................... 33
14.1 System Description .......................................................... 33
14.2 Initial System Setup ......................................................... 33
14.3 ULPA Filter Installation ....................................................... 33
14.4 Operating Instructions ....................................................... 33
14.5 Maintenance Procedures ..................................................... 34
14.6 Cleaning Procedures ........................................................ 34
14.7 Cautions .................................................................. 34
15. EMC Compliance Information for the LEEP PRECISION Integrated System .......... 35
16. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............. 36
17. Liability Statement ......................................................... 38
18. Warranty ................................................................. 39
19. Service and Repair ......................................................... 39
20. Explanation of Symbols ..................................................... 40
95 Corporate Drive
Trumbull, CT 06611 USA
Phone: [phone]
Fax: [phone]
www.coopersurgical.com
International
Phone: [phone]
Fax: [phone]
EMERGO EUROPE
Prinsessegracht 20
2514 AP The Hague
The Netherlands
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA

5
Section 1 Description
1.1 Introduction
The LEEP PRECISIONTM Integrated System, which includes the following components:
1.2 LEEP PRECISION Generator Description
The LEEP PRECISION Generator has the following features:
– Isolated power output and LED display located in the front for power selection, delivery, and ease of
use
– Flush faceplate membrane to facilitate operation and cleaning
– Microprocessor-based controls for increased precision, accuracy, reproducibility, and safety
– A choice of CUT, BLEND, and COAG waveforms to accommodate subtle differences
in technique and electrode performance
– Hand or foot activation for precise operation
– Patient return monitor that disables power automatically if Patient Return Electrode is loose
– Self-monitors all detectors
1.3 LEEP PRECISION Smoke Evacuator Description
The CooperSurgical LEEP PRECISION Smoke Evacuator System three-stage air ltration system is
used to remove airborne particulate plumes produced during ofce and surgical procedures, and has
the following features:
– Low noise level
– Triple filtration of air provides an efficiency level of 0.014 microns rated at 99.999 percent. This
includes a pre-filter, a charcoal filter for odor removal, and a final safety filter placed after the
charcoal filter
– High air flow for plume collection
– Attaches to the CooperSurgical LEEP PRECISION Integrated System
1.4 LEEP PRECISION Cart (with attached LEEP PRECISION Integration Unit) Description
The LEEP PRECISION Cart:
– The LEEP PRECISION Generator and Smoke Evacuator in one unit
– Heavy-duty casters for mobility
– Storage shelves
Purpose of the LEEP PRECISION Integration Unit:
– The LEEP PRECISION Integration Unit controls the ON/OFF power of the entire LEEP PRECISION
Integrated System. (The LEEP PRECISION Generator and Smoke Evacuator
are powered through the LEEP PRECISION Integration Unit.)
LEEP PRECISION Integrated System
LP-10-120 Generator, 120 VAC Smoke Evacuator 120 VAC Cart Integration Unit, 120 VAC
LP-10-220 Generator, 230 VAC Smoke Evacuator 230 VAC Cart Integration Unit, 230 VAC

LEEP
PRECISION
Generator
(below)
Section 2 Unpacking and Assembly
•Locate all product boxes.
2.1 Unpacking Shipping Carton
1. Remove the LEEP PRECISION Smoke Evacuator.
2. Remove the LEEP PRECISION Generator box.
3. Remove the LEEP PRECISION Cart.
CAUTION: DO NOT PICK THE CART UP BY ITS HANDLES TO REMOVE FROM THE SHIPPING BOX.
THE HANDLES ARE NOT DESIGNED TO ACCOMMODATE THE FULL WEIGHT OF THE CART.
6
Photo A
LEEP
PRECISION
Smoke
Evacuator
LEEP
PRECISION
Cart

7
Figure 1
2.2 Unpacking and Installing the LEEP PRECISION Smoke Evacuator
After unpacking the LEEP PRECISION Smoke Evacuator:
1. Undo the Velcro®strap located at the rear of the LEEP PRECISION Cart.
2. Plug in the connector [located at (B) in Figure 1] from the LEEP PRECISION Integration Unit to the rear of the
LEEP PRECISION Smoke Evacuator.
3. Put the LEEP PRECISION Smoke Evacuator in the designated area (slide in place).
4. Refasten the Velcro strap.
Install the LEEP PRECISION Generator next.
2.3 Unpacking and Installing the LEEP PRECISION Generator
After unpacking the LEEP PRECISION Generator:
1. Turn on the power switch on the LEEP PRECISION
Generator (put the switch in the ON position (“ ”)).
The LEEP PRECISION Generator can now be placed
into the sleeve which hangs over the LEEP PRECISION
Smoke Evacuator.
2. Rotate the cart so the handle is in the front.
The plug on the LEEP PRECISION Integration Unit
(inside the sleeve) ts into the receptacle of the LEEP PRECISION Generator. Gently press the LEEP
PRECISION Generator into place.
Shelves
LEEP PRECISION
Generator
Locking Casters (wheels)
LEEP
PRECISION
Smoke
Evacuator
Connector for
the LEEP
PRECISION
Smoke
Evacuator
Handle Bar
Isometric View Back View
LEEP PRECISION Cart
(A)
To the outlet
Main Power
Switch LEEP PRECISION
Integration Unit
Hooks (1 of 4)
LEEP PRECISION
Smoke Evacuator
plug located here
in the rear
(B)
Velcro for the LEEP
PRECISION
Smoke Evacuator

12
13
14
2.4 Installing the Filters and Tubing to the LEEP PRECISION Smoke Evacuator
2.4.1 ULPA Filter Installation
Tilt the LEEP PRECISION Smoke Evacuator forward and insert the large
ULPA Filter Cylinder with the Air Flow arrow pointing downward
(see Photo B).
2.4.2 Installing the Pre-Filter
Prepare the unit for use by inserting a clean, disposable Pre-Filter
(Single Patient Use) onto the ULPA Filter Cylinder (see Photo C).
Be sure the device is firmly seated.
2.4.3 Connecting the Tubing
There are two tubing hookup options:
1. For procedures requiring close-proximity plume removal (i.e., vaginal speculum)
2. For procedures requiring open-area plume removal (i.e., external lesions)
For procedures requiring close-proximity plume removal (i.e., vaginal speculum)
Assemble the ⅜-inch Reducer (REF 6083) onto the port on the
disposable Pre-Filter (REF 6081) top with a slight twisting
motion. Attach one end of an appropriate length of ⅜-inch ID
Evacuation Tubing (REF 6084) to the Reducer connector and
direct the other end to the patient and any appropriate device being used,
such as a vaginal speculum equipped with a
Smoke Evacuation Adapter (see Photo D).
For procedures requiring open-area plume removal (i.e., external
lesions)
Assemble the sterile Disposable Evacuation Tubing (REF 6084) directly into the top of the Pre-Filter.
Position the opposite end over the site to be treated.
2.5 Connecting the LEEP PRECISION Integrated System
to the Wall Outlet
Make sure the ON/OFF Switch for the LEEP PRECISION
Integrated System, located on the LEEP PRECISION Integration
Unit, is in the OFF position (“O”). Next, attach the power cord to
the receptacle on the LEEP PRECISION Integration Unit and
then into a hospital-grade grounded wall outlet to obtain power [refer
to (A) in Figure 1].
Photo B
Photo C
Photo D
8
12
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9
2.6 Installing the Foot Pedal Switch on the LEEP PRECISION Generator
Connect the Foot Pedal Switch to the socket shown in Figure 2 if foot control is desired.
2.7 Installing the Active and Dispersive Electrodes
2.7.1 Placement of the Active Electrode
• Connect the Active Electrode to socket shown in Figure 2.
2.7.1.1 For Foot Switch-Operated Electrode Use (with Adapter)
A 4 mm Reusable Electrosurgical Adapter is supplied with the LEEP PRECISION
Integrated System (found in the LEEP PRECISION Generator box). Use the Foot
Switch-Operated Electrode with the Adapter. The Electrode is plugged into the Adapter, which is then plugged
into socket shown in Figure 2.
2.7.2 Placement of the Dispersive Electrode or Patient Return Electrode
When using an electrosurgical system, it is very important that all of the current delivered to the
patient returns correctly to the LEEP PRECISION Generator via the Patient Return Electrode only.
• Connect the Dispersive Electrode to socket . Refer to Figure 2.
• The patient must be positioned correctly on the operating table. The patient and operator must
not come in contact with any metal conductive surfaces.
• The Patient Return Electrode must securely contact a vascular area close to the operating site. For a
gynecology procedure, the preferred site is the patient’s thigh. The contact area must be clean, free of body
lotions, shaved, and massaged for good circulation. The Patient Return Electrode contact area must be
maximized and frequently checked for uniform contact during the procedure, especially if the patient has
moved or if liquids have come in contact with the Patient Return Electrode. The Patient Return Electrode
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 Active Electrode/Patient Return Electrode Cables, etc.
Figure 2
5
8
1
7
3
2
7
5
8
4
7

Figures 3 through 5 show the proper and improper ways of hooking up and using the various Active
Electrodes and Patient Return Electrodes on the patient.
IMPROPER
LEEP PRECISION Generator Burn occurs at small
grounded contact
Surgeon touches electrode
to grounded object
Isolated
ESU
RF current ows from ground
through EKG pad, through
patient to Patient Return Electrode
LEEP PRECISION
Generator RF current ows from
electrode
Burn occurs at small
grounded contact
Isolated or
grounded ESU
Patient Return Electrode
touches grounded table RF current returns to Patient Return
Electrode via ground path
RF EKG
IMPROPER
LEEP PRECISION
Generator RF current through
patient to Patient Return
Electrode
Active Electrode
Grounded
Metal Case
Patient
Two-conductor patient
electrode continuity
monitor
Patient Return Electrode
(Thigh)
Patient may be grounded
PROPER
EKG
RF
10
Figure 3
Figure 4
Figure 5

11
2.7.2.1 Patient Return Electrode Use
There are two varieties of Patient Return Electrodes that can be used with the
LEEP PRECISION Integrated System:
( ): If the Patient Return Electrode with the built-in cable is purchased, the Patient Return
Electrode Cable is plugged directly into socket .
( ): If the Patient Return Electrode and a separate Reusable Cable are purchased, the
Patient Return Electrode is connected to the Reusable Cable, which is then plugged
into socket .
Section 3 LEEP PRECISION Generator Features
•Electronic power level control
•Digitally derived waveforms
•Low inherent leakage rate
•Patient return monitor disables power automatically if Patient Return Electrode is loose
•Regulated system performance traceable to NIST Standards
•Automatic smoke evacuator signal function sends signal to detector for automatic smoke evacuator actuation
when generator is activated
•Self-monitors all detectors
Classication
Model Safety Class Type
LEEP PRECISION Generator IBF
• Do not get uid into the LEEP PRECISION Generator. Should any liquid or solid object fall into the unit, unplug
the unit and call Technical Support.
•The LEEP PRECISION Generator is suitable for intermittent operation with a two-minute ON and six-minute
OFF duty cycle.
• The LEEP PRECISION Generator is classied as normal equipment (IPX0) according to protection against
ingress of water.
Patient Return Electrode
With Connector
Patient Return Electrode
Without Connector
The Cable is built in Reusable Cable is purchased
separately from CooperSurgical
8
8
1 2
1
2

Section 4 Front and Rear Panels of the LEEP PRECISION Generator
and Integration Unit
4.1 Front Panel of the LEEP PRECISION Generator
(Cart not shown)
PATIENT PAD LOOSE
R/F LEAKAGE ERROR
SYSTEM READY
R/F ON
12
Figure 6 (Front Panel)
Pilot Lights
(Colored, numbered boxes are also
located later in this manual.)
1Indicator Lights
WAIT = Red
CUT = Yellow
BLEND = Yellow
COAG = Blue
2
3
Power Indications
Digital LED Display
Acoustical
Piezo Annunciator (internal)
Operator Pushbuttons
Controls
4
a) PURGE* Turns LEEP PRECISION Smoke Evacuator
on for 5 sec.
b) RAISE Increases power setting
c) LOWER Decreases power setting
d) WAIT Standby mode
e) BLEND Cutting mode selection
f) CUT Cutting mode selection
g) COAG Cutting mode selection
4
1a-1g
1
3
7
8
5
2
Foot Switch Socket
A/C Power (rear panel)
Active Electrode Socket
Dispersive Electrode Socket
Remote Pencil Buttons (not shown)
5
6
7
8
* The LEEP PRECISION Smoke Evacuator may also be tested or used without the LEEP PRECISION Generator output
by pressing the “Purge Button” on the front panel. The motor will stay on for ve (5) seconds after the button is released.
Most purge operations (removing excess smoke) take only a few seconds.

4.2 Rear Panel of the LEEP PRECISION Generator
Symbols on the LEEP PRECISION Generator
Classication I Type BF protected against debrillator effects
Floating output circuit (Applied Part)
Cautions – consult this manual for safety precautions
Dangerous voltage
Equipotentiality Symbol (Ground)
4.3 LEEP PRECISION Integration Unit
IMPORTANT
The LEEP PRECISION Integrated System/Generator user must be thoroughly trained in
the techniques of Loop Electrosurgical Excision Procedures (LEEP). This system has
been designed for use with only the CooperSurgical LEEP PRECISION Electrosurgical
Accessories. DO NOT use this equipment for any purpose other than that for which it
has been designed. See Warnings and Caution statements throughout this manual.
13
10
6
LEEP PRECISION Generator
ON/OFF Switch
A/C Power Cord Connector
Fuse Holder
Rear Panel
10
9
Figure 7 (Rear Panel)
“Communication” Infrared LED between
the LEEP PRECISION Generator and
LEEP PRECISION Integration Unit (ON/
OFF) 11
11
9
6
Main Power Switch (ON/OFF)
The Power cord connects here and other end goes to
the wall outlet
The Connector with Cord is permanently mounted
on the LEEP PRECISION Integration Unit; the other end
plugs into the LEEP PRECISION Smoke Evacuator
12
13
14
12
13
LEEP PRECISION Integration Unit
14
Figure 8

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

15
5.3 Contraindications
• Pregnancy
• Known or suspected cervical changes secondary to DES (diethylstilbestrol) intrauterine exposure
• Acute or active inammation of the cervix, endometrium, fallopian tube, ovary or peritoneum
(cervicitis, endometritis, tubo-ovarian inammatory disease or pelvic inammatory disease)
• Invasive cancer that is visible on examination
•Less than three months postpartum
5.4 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.
5.5 Safety Precautions
1. The LEEP PRECISION Integrated System should be used only by a thoroughly trained physician in an
adequately equipped medical facility.
2. Replacement accessories and Patient Return Electrodes should be kept on hand as defective active
accessory or Patient Return Electrodes can result in substandard performance of this equipment.
3. The LEEP PRECISION Integrated System should be connected only 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 any part of the LEEP PRECISION Integrated System.
DO NOT use ammable 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. This equipment should only be used with CooperSurgical LEEP PRECISION Accessories and
CooperSurgical LEEP Disposable Accessories.
7. When this equipment is operated:
a. A Patient Return Electrode of adequate surface area MUST be properly attached to the patient
or the risk of accidental burns will exist.
b. The Patient Return Electrode should be placed as close as possible to the site of active
accessory use, 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!
8. 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.
9. The instructions for use described in this manual must be followed; otherwise, compromised safety,
malfunction, injury to the operator and/or patient, or costly damage to the LEEP PRECISION Integrated
System may occur.
10. 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
CooperSurgical (refer to Section 19).

5.6 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 specic technique and procedure that will accomplish the desired
clinical effect.
WARNING
LEEP PRECISION 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, physician, or
assistant is in contact with exposed metal
• Explosions caused by electrosurgical sparking in a ammable gas mixture
(i.e., explosive anesthetic gases and the inappropriate use of alcohol and
other ammable liquids)
•Perforation and massive hemorrhage
A proper Patient Return Electrode 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 Electrode has been applied.
5.6.1 Electrosurgical Tissue Effect
Delivery of continuous sinusoid waveform currents through a small electrode at appropriate power
levels can cause rapid heating of the intracellular uids in the cells in close proximity to the
electrode, turning these uids to steam. The signicant increase in volume (approximately ve times) causes
cellular structures 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 uids at a
more gradual pace. This allows evaporation of these uids 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,
in which tissue is divided with a desirable amount of hemostatis along the margins of the
divided tissue.
The LEEP PRECISION Generator has output load characteristics that cause the electrosurgical
effects to remain consistent throughout the procedure. However, under some circumstances, it may be
necessary to readjust the power settings during the procedure.
The electrosurgical effect may vary throughout the procedure, requiring the operator to adjust the
LEEP PRECISION Generator relative power settings.
16

17
5.6.2 Select the Output Mode (i.e., CUT, BLEND or COAG by Pushing
the Corresponding Button e, f , or g)
Output Mode Waveform Description General Effect
CUT Continuous 495 kHz sinusoid Cutting without Hemostatis
with minimal modulation
BLEND Interrupted 495 kHz sinusoid Cutting with minimal
intermediate-duty cycle Hemostatis
COAG Bursts of 495 kHz sinusoid Coagulation without Cutting
short-duty cycle
 5.6.3SettheOutputPowerlevel[conrmed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 conguration of the cutting wire. This may result in signicant changes in the
electrosurgical effect at a given output power level setting. The use of CooperSurgical
LEEP PRECISION Electrodes is recommended.
5.6.4 Attendant Risks of High Frequency Electrosurgery
Electrosurgery produces sparks that can ignite ammable materials. This includes solvents,
adhesives, gauze, cotton, and also liquids and gases.
Further risks include:
• Pooling of ammable agents under the patient in body depressions or in body cavities.
• Oxygen-saturated gauze and cotton wool
• Accumulated oxygen gas: under covers, drapes, or clothing
• Ignition of endogenous gases in or near body cavities or osses
5.6.5 Electrosurgery
Electrosurgery is the use of energy created by a high frequency alternating current. The
tissue’s resistance to the passage of this current creates heat internally in the tissue, as in diathermy.
Monopolar electrosurgery involves the use of two electrodes (an Active Electrode
and a Dispersive Electrode) of greatly different sizes. This results in greatly increased current
density at the point of the smaller electrode. While the electrode itself remains cold, the highly
concentrated high frequency energy creates molecular heat inside each cell. By the choice of
electrodes and selection and adjustment of the current, the operator controls the effect of this
energy on the tissues to achieve the desired results.
CAUTION
FOR MONOPOLAR SYSTEMS, IT IS RECOMMENDED TO KEEP
THE VOLTAGE/POWER AS LOW AS POSSIBLE TO ACHIEVE
THE DESIRED END EFFECT (due to the potential for capacitive
coupling and inadvertent burning at higher voltages).
With electronically generated electrosurgery current it is necessary to convert the 50/60 Hz
alternating current available at the wall outlet to the high frequency current needed for
electrosurgery. This conversion is accomplished by a high frequency generator. The high
1
1b and c and 3
NOTE: Numbers in blue boxes refer
to those component parts in Figure 6.

frequency waveforms are precisely controlled for the various modes of operation. The peak
average and RMS values of the desired waveforms are generated in accordance with
scientically and empirically derived standards that are known to result in the desired effects.
5.6.6 Fundamentals of Electrosurgery
As with any technical instrumentation or equipment, there are some fundamental principles that should be
learned in order to use electrosurgery safely and effectively. These principles apply
generally to all procedures in which electrosurgery is used. Users should familiarize themselves with them.
5.6.7 The Active Electrodes
Be sure the electrodes are securely seated and rmly held in the handpiece so that the entire
electrode shank is covered.
In general, straight wire electrodes are used for incisions and for removing ne tissue. Loops are used for
removing heavier tissue, planing, and contouring. Ball Electrodes are used for coagulation.
Keep the electrode clean while operating. Tissue shreds and debris on the electrode reduce the
effectiveness of the current and, by impeding the passage of the electrode through the tissue,
slow down the stroke. This creates unnecessarily heavy coagulation, which can cause sloughing and delay
healing.
Inspect the electrodes for proper insulation.
THIS DEVICE SHOULD ONLY BE USED BY PHYSICIANS TRAINED IN ELECTROSURGERY.
The practitioner who lacks experience should not attempt the procedures described in the
following pages based solely on this information.
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.
5.6.8 Thermal Effects on Tissue Treated with Loop Electrodes
Thermal effects on tissue specimens may include:
•Thermal coagulation injury of the cervix, up to one-third the thickness of normal epithelium
of the cervix
•Fragmentation of squamous epithelium of the cervix attributable to long exposure periods along the
excision site, which allow heat to dissipate laterally
•Partial coagulation of the endocervical epithelium because of lateral heat radiation.
The Loop Electrosurgical Excision Procedure may produce thermal effects at the periphery
of the excised tissue and may make histopathologic interpretation difcult or impossible and, therefore,
may not allow accurate diagnosis and may obscure the need for further treatment.
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Section 6 Electrosurgical Precautions
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 PRECISION Integrated System as well as thoroughly understand the principles and use of
electrosurgical systems.
WARNING
Electrosurgery uses radio-frequency energy to cut and coagulate tissue. Because of the
sparking and heat associated with electrosurgery, do not use with ammable anesthetics or
other ammable gases, near ammable uids or objects, or with oxidizing agents.
•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.

WARNINGS
•THIS DEVICE IS A BF-TYPE DEVICE. BF-TYPE EQUIPMENT IS A B-TYPE DEVICE WITH AN
F-TYPE APPLIED PART.
A B-Type device is a piece of equipment providing a particular degree of protection against electric
shock, particularly regarding:
•Allowable leakage current
•Reliability of the protective earth connection.
•
An F-Type device is an isolated applied part. The applied part is isolated from all other parts
of the equipment to such a degree that the patient leakage current allowable in single fault
condition is not exceeded when a voltage equal to 1.1 times the highest rated mains voltage
is applied between the applied part and earth.
•AVOIDING UNINTENTIONAL PATIENT BURNS
1. Do not activate the electrode until all components are in place.
2. Be certain to have an unobstructed path and view.
3. Use only non-conductive ancillary instruments.
4. Remove patient jewelry, metal drape clips, (etc.) and needles.
5. A Patient Return Electrode must be used. The entire area of the Patient Return Electrode should
be reliability attached to the patient’s body and as close to the operating eld as possible.
6. Place Foot Switch in safe position, out of trafc.
7. Turn console OFF or place in WAIT state when not in use.
8. Do not use unit on small appendages due to current density. Bipolar techniques may be
desirable for use on small appendages.
•THERMAL INJURY AND DEFECTS OF TISSUE TREATED WITH LOOP ELECTRODES
Possible injury to cervical tissue may include:
1. Thermal coagulation injury of the cervix, up to one-third the thickness of normal cervical
epithelium,
2. Fragmentation of squamous cervical epithelium attributable to long exposure periods along the
excision site that allows heat to dissipate laterally, and
3. Partial coagulation of the endocervical epithelium because of lateral heat radiation.
Loop Electrosurgical Excision Procedures may also produce thermal defects at the periphery of
the excised tissue and may make histopathologic interpretation difcult or impossible, preventing
accurate diagnosis and the evaluation of the need for further treatment.
•FLAMMABLE GASES / SOLUTIONS
1. When using a ammable preparatory solution, such as alcohol, be certain that the solution has
completely evaporated before using electrosurgery.
2. Electrosurgery should not be used in the presence of ammable or explosive gases.
3. It is recommended that only non-ammable agents be used for cleaning and disinfection.
SMOKE FROM PROCEDURES CONTAINS LIVE CELLS THAT MAY PRESENT BIOHAZARDS
(HIV, ETC.); USE A SMOKE EVACUATION DEVICE.
CONSULT THE PACEMAKER MANUFACTURER’S LITERATURE AND THE PATIENT’S
PHYSICIAN BEFORE USING THIS INSTRUMENT ON A PATIENT USING A PACEMAKER.
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