LEEP PRECISION Generator Operating Manual Rev A April 2017

TABLE OF CONTENTS Section

Content

Page

1.

Introduction ... 4

2.

Special Features ... 4

3.

Front and Rear Panels of the LEEP PRECISION Generator ... 5

3.1

Front Panel of the LEEP PRECISION Generator ... 5

3.2

Rear Panel of the LEEP PRECISION Generator ... 6

4. Assembly ... 7 4.1

Installing the Foot Pedal Switch on the LEEP PRECISION Generator ... 7

4.2

Installing the Active and Dispersive Electrodes ... 7

5.

Professional Use Guide ... 10

5.1

Indications for OB/GYN Applications ... 10

5.2

Contraindications for OB/GYN Applications ... 11

5.3

Electrosurgical Procedures ... 11

6.

Electrosurgical Precautions ... 14

7.

LEEP PRECISION Smoke Evacuator Operation ... 14

7.1

Automatic Mode Option ... 14

7.2

Purge Button ... 14

8.

Setup and Operation of the LEEP PRECISION Generator ... 14

8.1

Practice ... 14

8.2

The Power Setting ... 16

8.3

Cutting Techniques ... 17

8.4

Criteria of a Good Cutting Technique ... 17

8.5

Coagulating ... 17

8.6

Coagulating Technique ... 18

8.7

Technique Guidance ... 18

9.

LEEP PRECISION Patient Return Electrode... 19

10. Maintenance ... 19 11. Accessories ... 19 11.1

Disposable Hand Switch Pencils ... 20

12.

Liability Statement ... 20

13. Warranty ... 20 14. Service/Repair ... 21 15. Troubleshooting ... 22 16. Specifications... 23 16.1

Power Output Characteristics ... 24

16.2

Power Output at Various Load Resistance ... 25

17.

EMC Compliance Information for the LEEP PRECISION Generator ... 26

18.

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ... 27

19.

Explanation of Symbols ... 30 3

Section 1 Introduction The LEEP PRECISIONTM Generator was designed for office use. Read this manual carefully and follow the recommended program of practice. The manual covers applications and techniques for use as well as setup and maintenance of your LEEP PRECISION Generator. For any questions or problems, call the local CooperSurgical representative or write to: CooperSurgical, Inc. ATTN: Customer Service Department 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com International Phone: (203) 601-9818 Fax: (203) 601-4747

Section 2 Special 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

4

Section 3 Front and Rear Panels of the LEEP PRECISION Generator 3.1 Front Panel of the LEEP PRECISION Generator

(Colored, numbered (Colored, numberedboxes boxesare are also located also located later laterininthis thismanual) manual)

3

7 4 1

8

5

2

1a - 1g

Controls 1

Indicator Lights 2 WAIT CUT BLEND COAG

Operator Pushbuttons a) PURGE b) RAISE c) LOWER d) WAIT e) BLEND f) CUT g) COAG

Turns LEEP PRECISION Smoke Evacuator on for 5 sec. Increases Power Setting Decreases Power Setting Stand-by Mode Cutting Mode Selection Cutting Mode Selection Cutting Mode Selection

= = = =

Red Yellow Yellow Blue

Power Indications 3 Digital LED Display Acoustical Piezo Annunciator Pilot Lights 4

Foot Switch Socket 5

PATIENT PAD LOOSE R/F LEAKAGE ERROR SYSTEM READY R/F ON

A/C Power (rear panel) 6 Active Electrode Socket 7 Dispersive Electrode Socket 8 Remote Pencil Buttons (not shown)

5

3.2 Rear Panel of the LEEP PRECISION Generator

9

6

10

11 Figure 2 (Rear Panel)

Rear Panel - LEEP PRECISION Generator ON/OFF Switch 6 A/C Power Cord Connector 9 Fuse Holder 10

“Communication” Infrared LED between the LEEP PRECISION Generator and LEEP PRECISION Integration Unit (ON/OFF) 11

Symbols on the LEEP PRECISION Generator Classification I Type BF protected against defibrillator effects Floating output circuit (Applied Part) Cautions – consult this manual for safety precautions Dangerous voltage Equipotentiality Symbol (Ground)

IMPORTANT The LEEP PRECISION 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.

6

Section 4 Assembly 4.1 Installing the Foot Pedal Switch on the LEEP PRECISION Generator Connect the Foot Pedal Switch to the socket 5 shown in Figure 1 if foot control is desired.

4.2 Installing the Active and Dispersive Electrodes 4.2.1 Placement of the Active Electrode Connect the Active Electrode to socket 7 shown in Figure 1. 4.2.1.1 For Foot Switch-Operated Electrode Use (with Adapter) A 4 mm Reusable Electrosurgical Adapter is supplied with the LEEP PRECISION Generator (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 7 shown in Figure 1. 4.2.2 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 8 . Refer to Figure 1. • 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. 4.2.2.1 Patient Return Electrode Use There are two varieties of Patient Return Electrodes that can be used with the LEEP PRECISION Generator:

­­

1

­­­­

2

Patient Return Electrode With Connector

Patient Return Electrode Without Connector

The Cable is built in

Reusable Cable is purchased separately from CooperSurgical

( 1 ): If the Patient Return Electrode with the built-in cable is purchased, the Patient Return Electrode Cable is plugged directly into socket 8 .

( 2 ): 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 8 .

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. PROPER

LEEP PRECISION Generator

RF current through patient to Patient Return Electrode

Active Electrode

Patient

Grounded Metal Case

Patient Return Electrode (Thigh)

Two-conductor patient electrode continuity monitor

Patient may be grounded

Figure 3 IMPROPER LEEP PRECISION Generator

Burn occurs at small grounded contact

EKG

RF Isolated ESU

Surgeon touches electrode to grounded object

RF current flows from ground through EKG pad, through patient to Patient Return Electrode

Figure 4 IMPROPER LEEP PRECISION Generator

RF current flows from electrode

Burn occurs at small grounded contact RF

EKG

Isolated or grounded ESU

Patient Return Electrode touches grounded table

Figure 5 8

RF current returns to Patient Return Electrode via ground path

WARNINGS •

THIS DEVICE IS A BF-TYPE DEVICE. BF-TYPE EQUIPMENT IS B-TYPE DEVICE WITH AN F-TYPE APPLIED PART.

A B-Type device is 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 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 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 field as possible. 6. Place Foot Switch in safe position, out of traffic. 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 the 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 difficult or impossible, preventing accurate diagnosis and evaluation of the need for further treatment. •

FLAMMABLE GASES/SOLUTIONS

1. When using a flammable 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 flammable or explosive gases. 3. It is recommended that only non-flammable 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.

9

CAUTIONS •

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.

•

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 high voltages).

•

Adequate anesthesia is indicated for all electrosurgical procedures.

•

Inspect loop and ball for adequate insulation.

•

Avoid using an electric extension cord (danger of separation).

•

Use a smoke evacuator with this device.

•

This device generates high frequency energy that could, under some circumstances, cause interference to other equipment.

•

For situations where the MAXIMUM OUTPUT VOLTAGE is less than or equal to 1600V, ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES should be selected that have a RATED ACCESSORY VOLTAGE equal to or greater than the MAXIMUM OUTPUT VOLTAGE.

-

ASSOCIATED EQUIPMENT and ACTIVE accessories should be selected with RATED ACCESSORY VOLTAGE ≥ MAXIMUM OUTPUT VOLTAGE when the smaller of variable y (see below) or the number 6 is ≤ CREST FACTOR for that HF SURGICAL MODE. When MAXIMUM OUTPUT VOLTAGE (Umax) is > 1600 V, and the CREST FACTOR is < the variable y calculated below, indicating that any ASSOCIATED EQUIPMENT and ACTIVE ACCESSORIES used in such mode or setting must be rated to withstand the combination of actual voltage andm CREST FACTOR.

y=

Umax – 400 [Volts] 600 [Volts]

•

No modification of this equipment is allowed.

•

No customer-serviceable parts.

•

Only replacment of power cords or fuses can be done by the user. Only replace with these items with the exact replacement part(s) available from CooperSurgical.

Warning: To avoid risk of Electrical Shock, this equipment must only be connected to a supply mains with protected earth.

Section 5 Professional Use Guide 5.1 Indications for OB/GYN Applications •

Cervical conization

•

External anogenital lesion

•

Large vaginal intraepithelial neoplastic (VAIN) lesions

• Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias

10

5.2 Contraindications for OB/GYN Applications • • •

Pregnancy Known or suspected cervical changes secondary to DES (diethylbestrol) intrauterine exposure Acute or active inflammation of the cervix, endometrium, fallopian tube, ovary or peritoneum (cervicitis, endometritis, tubo-ovarian inflammatory disease or pelvic inflammatory disease)

•

Invasive cancer that is visible on examination

5.3 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 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 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 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.

5.3.1 Electrosurgical Tissue Effect Delivery of continuous sinusoid waveform currents through a small electrode at appropriate power levels can cause rapid heating of the intracellular fluids in the cells in close proximity to the electrode, turning these fluids into steam. The significant increase in volume (approximately five times) causes cellular structure to rupture, creating the clinical effect of CUT, with little or no hemostatic effort along the margin of the divided tissue. Delivery of short duration pulses of R/F 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 with the division of tissue. By varying the pulse to an intermediate duration, it is possible to get a clinical effect to combine the clinical characteristics of CUT and COAG, yielding the effect referred to as “blend,” in which tissue is divided with a desirable amount of hemostasis along the margins of the divided tissue.

11

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. 5.3.2 Select the Output Mode (i.e., CUT, BLEND or COAG by Pushing the Corresponding Button 1 e, f, or g) Output Mode

Waveform Description

General Effect

CUT

Continuous 495 kHz sinusoid with minimal modulation

Cutting without Hemostatis

BLEND

Interrupted 495 kHz sinusoid intermediate-duty cycle

Cutting with minimal Hemostatis

COAG

Bursts of 495 kHz sinusoid short-duty cycle

Coagulation without Cutting

5.3.3 Set the Output Power Level [confirmed on the digital display ( 1 b and c and 3 )] 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 PRECISION Electrodes is recommended. 5.3.4 Attendant Risks of High Frequency Electrosurgery Electrosurgery produces sparks that can ignite flammable materials. This includes solvents, adhesives, gauze, cotton, and also liquids and gases. ‘ Further risks include: • • •

Pooling of flammable 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 a body cavity or os

5.3.5 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, 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 high voltages).

12

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 using a high frequency generator. The high 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 scientifically and empirically derived standards which are known to result in the desired effects. 5.3.6 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. 5.3.7 The Active Electrodes Be sure the electrodes are securely seated and firmly held in the handpiece so that the entire electrode shank is covered. In general, straight wire electrodes are used for incisions and for removing fine 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, slows down the stroke. This creates unnecessarily heavy coagulation, which can cause sloughing and delay healing. Inspect the electrodes for proper insulation. THIS DEVICE SHOULD BE 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; instead, the skills required should be acquired in the time-honored preceptor manner. 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. 5.3.8 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 difficult or impossible and, therefore, may not allow accurate diagnosis and may obscure the need for further treatment.

13

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 these operating instructions supplied with the CooperSurgical LEEP PRECISION Generator 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 flammable anesthetics or other flammable gases, near flammable fluids 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.

Section 7 LEEP PRECISION Smoke Evacuator Operation 7.1 Automatic Mode Option The CooperSurgical Smoke Evacuation System is set up to operate automatically from the LEEP PRECISION Generator. This is accomplished by means of a special Infrared Light Emitting Diode (IR LED) in the Integration Unit, which is mounted on the LEEP PRECISION Generator’s rear panel. When the R/F Output is activated by the operator, the rear panel LED produces an output that is received by the interface module of the interface assembly. The motor will come ON and stay ON for five (5) seconds after the energized output is terminated.

7.2 Purge Button The LEEP PRECISION Smoke Evacuator may also be tested or used without the LEEP PRECISION Generator output by pressing PURGE on the front panel. The motor will stay on for five (5) seconds after the button is released. Most purge operations (removing excess smoke) take only a few seconds.

Section 8 Setup and Operation of the LEEP PRECISION Generator 8.1 Practice Cutting and coagulating are described in the following section. First, practice methods are suggested, including how to adjust the settings for optimal cutting and coagulating. Then general techniques are described, which should help determine and develop the best specific techniques. 1. Place the console on a flat, stable surface near the Smoke Evacuator. 2. Connect the A/C power cord(s) accordingly. Plug the removable Foot Switch into the front panel if foot control is desired. Set it up in a convenient low-traffic area. 3. Set the ON/OFF switch to OFF, and plug the console into a grounded 120 VAC or a grounded 230 VAC electrical receptacle. This is an important safety feature. 4. Use only CooperSurgical-approved disposable accessories. See pages 18 and 19 for further information. 5. Remove the disposable Patient Return Electrode from its packaging and attach it to the patient in accordance with the instructions. Be sure to follow all instructions regarding the location of the Patient Return Electrode, to ensure that good contact is made with the patient. 6. Attach the Patient Return Electrode securely to the Dispersive Electrode Socket 8 on the LEEP PRECISION Generator’s front panel.

14

7. Insert the Active Electrode into the Active Electrode Socket 7 on the top right side of the LEEP PRECISION Generator’s front panel. Either the Hand Switch-Operated Electrode (Pencil) or the Foot Switch-Operated Electrode (Pencil) may be used. 8. Insert the selected Electrode (Needle, Loop, Square or Ball) into the Active Electrode. 9. Set the ON/OFF switch to ON. A red indicator lamp on the console (R/F ON) 4 will indicate that the hold mode has been initialized. After Self-Check, the SYSTEM READY LED 4 (green) will illuminate.

NOTES

If the LEEP PRECISION system does not cycle to the SYSTEM READY status and a series of prolonged audible beeps are heard, turn the system off and check for faulty hand, foot, or panel switches. See the TROUBLESHOOTING section (page 22, Section G) of this manual for additional information. Do not be alarmed if the LEEP PRECISION Smoke Evacuator turns on at this point. This is the unit cycling.

10. Ensure patient is connected securely to the Patient Return Electrode before beginning.

WARNING

POSITIVE CONTACT MUST BE COMPLETE BETWEEN THE PATIENT AND THE PATIENT RETURN ELECTRODE. IF NOT, SEVERE BURNING OF TISSUE MAY RESULT. THE ENTIRE AREA OF THE PATIENT RETURN ELECTRODE SHOULD BE RELIABILY ATTACHED TO THE PATIENT’S BODY AND AS CLOSE TO THE OPERATING FIELD AS POSSIBLE. 11. The output is selected by the mode selector buttons. When a mode is selected, the intensity should be set by depressing the RAISE ( 1 b) or LOWER ( 1 c) button. If either CUT (pure cut/blended cut) or COAG mode is selected and the Foot Switch is depressed, the output will be active. When the Foot Switch or Active Electrode is actuated, the R/F ON lamp 4 will illuminate and the beeper will emit a pulsing tone. 12. The LEEP PRECISION Generator is ready for use and the SYSTEM READY LED 4 (green) will illuminate. If the operator feels the output of power is not sufficient, the Patient Return Electrode should be checked to see that good contact is made with the patient before increasing the power setting. 13. CROSS CONTROL: The sequence of operation of the LEEP PRECISION Generator is nonpreferential; that is, either the Foot Switch (pedal) or the Hand Switch will activate the output (providing all safety measures are met). The Foot Switch and the Hand Switch cannot be operated simultaneously.

IMPORTANT

If using the Foot Switch, the button on the front panel must be used to control the OUTPUT mode. When the COAG mode ( 1 g) is selected on the front panel, the CUT or BLEND modes cannot be invoked by the Hand Switch (yellow) Button. The CUT mode, if desired, must be selected on the front panel and then invoked either by the Hand Switch- or the Foot Switch-operated pencil.

WARNING

Positive contact must be complete between the patient and the Patient Return Electrode. If a Split/Dual Patient Return Electrode is not securely affixed to the patient, the PATIENT PAD LOOSE indicator LED 4 (red) will indicate an improper return path. The PATIENT PAD LOOSE safety circuitry disables the output when an unsafe condition occurs in the Patient Return Electrode circuit. Poor connections or insufficient contact area can cause R/F burns. The entire area of the Patient Return Electrode should be reliability attached to the patient’s body and as close to the operating field as possible. Use only approved CooperSurgical LEEP PRECISION Dual/Split Patient Return Electrodes. Do not use a single (not split) Patient Return Electrode as it may cause severe tissue burns in the vicinity of the Patient Return Electrode.

15

14. CABLE PLACEMENT: High frequency cables should be routed clear of other instruments and arranged for minimum length. Cables to surgical electrodes should be positioned to prevent contact with the patient or other leads. Temporarily unused active electrodes should be stored in a location isolated from the patient. 15. R/F LEAKAGE: The LEEP PRECISION Generator has a sensitive error detection mode that disables the output and indicates that an error condition exists by illuminating the front panel R/F LEAKAGE ERROR LED 4 (red). This LED will indicate that an undesirable path exists from the Patient Return Electrode or Active Electrode to ground. In this context ground means any undesirable path or place. If such a path exists, the patient should be inspected for any contact with metallic paths to tables, chairs, or other non-isolated objects. The purpose of this feature is to prevent R/F current from flowing in undesirable places where it could either cause burns or damage to ancillary equipment. 16. PATIENT CONTACT: Direct operator-to-patient skin-to-skin contact could create an undesired leakage path. Avoid skin-to-skin contact by padding with dry gauze as necessary. The operator should wear electrically insulating gloves. Unless absolutely necessary, the patient should not be touched when R/F power is activated. Patient should not come into contact with grounded metal parts or parts with a higher capacitance to ground (i.e., operating table supports). Use of anti-static sheeting is recommended for this purpose.

8.2 The Power Setting Select the operating mode (CUT, BLEND, COAG, or WAIT) by using the mode selector buttons. When a mode is selected, the intensity should be set by depressing the POWER RAISE ( 1 b) or LOWER ( 1 c) button that controls the digital display. When a mode is selected, the corresponding LED illuminates in the corner of each button to verify which mode is engaged. To ensure correct operation of the instrument, the colors are correlated to International Standards: WAIT BLEND CUT COAG

= = = =

Red Yellow Yellow Blue

When the Foot Switch is depressed or the Hand Switch buttons are pressed, the R/F ON 4 (yellow) will illuminate. If either the CUT ( 1 f) (pure or blend) or COAG ( 1 g) mode is selected and the Foot Switch is depressed, the output will be active. In the WAIT ( 1 d) mode there will be no output. The PIezo Electric Annunciator will indicate with an intermittent tone when the R/F Power is present at the output. Once contact is made with the electrode to the tissue and a small current is flowing, the tone will become steady. The ideal power setting is the minimum setting at which cutting and coagulating meet the criteria described on pages 16 and 17. If the power is too high, the tissue will be discolored and there will be considerable sparking when the electrode contacts the surface. If the power is too low, the electrode will drag through the tissue, tearing and burning instead of cutting cleanly, and will pick up shredded and torn tissue. Power requirements will vary with the type and size of the electrode, the area of electrode surface in contact with the tissue, the nature of the tissue, whether cutting or coagulating, and the depth of the incision desired. Larger electrodes, deeper incisions, and tough fibrotic tissue are some indications for higher power settings.

CAUTIONS

Do not use fine Needle Electrodes at high settings as they may be severely damaged by such use. When practicing with these electrodes, work up gradually from a low setting. Generally, you should not exceed a setting of 40 with fine Needle Electrodes. Do not use monitoring Needle Electrodes during electrosurgery. If monitoring electrode cables are used, they should be placed as far away from electrosurgical cables AS POSSIBLE. If it is absolutely necessary to cross over any monitoring cable or patient-connected tubes, such as IV lines, the crossing should be at right angles. Use of monitoring systems incorporating high frequency current limiting devices is recommended.

16

8.3 Cutting Techniques When cutting, ALWAYS activate the electrode by stepping on the Foot Switch or pressing the yellow button on the Active Electrode (Pencil) BEFORE making contact with the tissue. Plan the stroke. Before activating the electrode, take one or two practice strokes to be sure you can complete the planned stroke comfortably and correctly. At this time you can evaluate the size and shape of the electrode and the speed and depth of the stroke. When the practice stroke is comfortable, step on the Foot Switch or press the yellow button on the Active Electrode (Pencil) and make the planned cut. Use a smooth brushing motion without pressure. The electrode should pass through the tissue, WITHOUT DRAGGING, at a deliberate but not slow speed. Keep the electrode moving. Prolonged contact with any one part of the tissue can create excessive coagulation. 8.3.1 Cutting Blend: Cutting is done not by the electrode, but by the high frequency energy concentrated at the electrode’s tip. This high frequency energy generates molecular heat in each cell to the point at which the fluids in the cell vaporize and the cell explodes. By applying this energy to individual cells in sequence, that is, by moving the electrode continuously through the tissue, the line of destruction is limited and the cutting effect is realized. At the same time, the capillaries are sealed, resulting in almost bloodless cutting, hence the term “blended cut.” Pure cut: This is almost like using a cold scalpel with very little or no hemostasis.

8.4 Criteria of a Good Cutting Technique There are three criteria of a good cutting technique: 1. The electrode should “float” through the tissue without dragging or resistance. 2. There should be only very slight, if any, change in the tissue color due to dehydration or charring. 3. No tissue shreds should adhere to the electrode.

8.5 Coagulating The LEEP PRECISION Generator is designed for high fulguration so tissue bleeders can be sealed without burning the uninvolved tissue. Coagulation takes place when the high frequency current is applied to the tissue with a current density sufficiently concentrated to dehydrate the cells and coagulate their organic contents, but without penetrating deeply into the tissue. This procedure is almost self-limiting because the surface coagulation first created protects the underlying tissue against excessive depth of coagulation. Coagulation appears as a white spot on the surface of the tissue, emanating from the point of contact to the Ball Electrode. The depth of coagulation is approximately equal to the lateral spread of coagulation. In contrast to cutting, when coagulating, the Ball Electrode should make contact with the tissue before the physician depresses the Foot Switch or Hand Switch. Start with a LOW power setting (15), changing the mode button to COAG. Make light contact the surface of the tissue with the Ball Electrode. Depress the Foot Switch or Hand Switch to activate the current, coagulating the area for several seconds, then release the Foot Switch or Hand Switch and remove the electrode from the tissue.

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Note the appearance of the tissue, which should appear blanched. Turn the power intensity up step by step, repeating the procedure. Observe the characteristics of the coagulated tissue with each setting. The degree of coagulation obtained at a particular setting will vary with different tissue and different conditions. Determine which setting is best for various procedures. When treating any condition, if proper coagulation is not apparent after one application, immediately increase the intensity setting if the Patient Return Electrode is properly in place.

CAUTION

Never repeatedly apply the current to the same area; this may create heat and seriously damage underlying tissues.

8.6 Coagulating Technique The Ball Electrode is useful for controlling hemorrhage. When applied for a second or two, electronic coagulation current will coagulate small capillaries easily. Larger vessels can be picked up with hemostats, which in turn may be touched by the Ball Electrode using electronically generated current. This will seal all vessels that are held in the tips of the forceps.

NOTE

Always make contact with the tissue before depressing the Foot Switch or Hand Switch when using the coagulation current.

8.7 Technique Guidance 8.7.1 For OB/GYN Procedures 1. The endocervix may not be included in the loop excision, and the results of endocervical curettage (ECC) may not be predictive of either residual or invasive disease after loop excision procedures. If the ECC is positive for dysplasia, a standard cone biopsy should be considered. 2. Loop Electrosurgical Excision Procedures performed with small diameter wire Loop Electrodes produce multiple small pieces of cervical tissue and may provide a less acceptable tissue specimen for histopathologic analysis. 3. Larger lesions involving multiple quadrants of the cervix are more difficult to remove with Loop Electrodes. 8.7.2 For Severed Vessels 1. Clamp the bleeder with a hemostat. 2. Using electronically generated current, touch a Ball Electrode to any part of the hemostat. 3. Depress the Foot Switch Pedal to activate the current for several seconds, then release the Pedal and remove the electrode. Be sure the current is set as high as is necessary to achieve coagulation. 4. After the application of coagulating current, remove the hemostat. Bleeding should have stopped; if not, repeat the procedure. Suture ligation may be required if R/F is unsuccessful. 5. When using electronically generated current, it is safe to hold the hemostat in a gloved hand while holding the electrode handle in the other during this procedure. 8.7.3 For Anesthesia Adequate anesthesia is indicated for all electrosurgical procedures. It is usually advisable to anesthetize tissue adjacent to the intended operative site in the event it becomes necessary to extend the operative area.

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8.7.4 For Biopsy The use of electrosurgery for cervical biopsy has advantages in that it seals the capillaries and lymphatics as it cuts. Whenever possible, the specimen should include two to three millimeters of attached normal tissue. Small (up to one half inch) masses should be removed in one piece. Using a cutting current at a relatively high setting and a Needle Electrode, incise all around the mass in an elliptical pattern, including two to three millimeters of attached normal tissue. Small masses may also be removed by using a suitable Loop Electrode – large enough so that it can excise the mass as well as two to three millimeters of attached normal tissue at the same time. Specimens from larger masses should be taken in the form of wedges. Using a Needle Electrode and cutting current, start at the apex of the wedge at the center of the suspicious mass. The base of the wedge should include two to three millimeters of attached normal tissue.

Section 9 LEEP PRECISION Patient Return Electrode A Patient Return Electrode must be used to operate the LEEP PRECISION Generator. The Patient Return Electrode must be of the Split or Dual type for the safety features to prevent R/F burns due to poor adhesion.

NOTE

For optimum patient safety with the use of the LEEP PRECISION Generator, it is strongly recommended to use only authorized and genuine CooperSurgical LEEP PRECISION Split/Dual Patient Return Electrodes. No other Patient Return Electrode has been tested or verified to the level of safety and performance of an authorized and genuine CooperSurgical LEEP PRECISION Split/Dual Patient Return Electrode.

WARNING Do not use a single/not split Patient Return Electrode as it is not continuously monitored for integrity. Patient injury may result.

Section 10 Maintenance The LEEP PRECISION Generator must be cleaned and disinfected after each use. To sanitize the LEEP PRECISION Generator, wipe down with a disinfectant. While the finish on the LEEP PRECISION Generator will resist scuffing and the chemical attack of most acids and alkalies, any liquids spilled on the LEEP PRECISION Generator should be wiped up immediately.

Section 11 Accessories Use only CooperSurgical LEEP PRECISION accessories for optimal system performance and patient safety. The list includes, but is not limited to: - LEEP Loop Electrodes - LEEP Square Electrodes - LEEP Needle Electrodes - LEEP Ball Electrodes - Patient Return Electrodes - Hand Switch-Operated Electrodes (Pencils) - Foot Switch-Operated Electrodes (Pencils) - 4 mm Reusable Electrosurgical Adapter (for Hand Switch-Operated Electrodes) - Foot Pedal The use of non-CooperSurgical-authorized and genuine accessories is not recommended as they have not been tested for use with this system.

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11.1 Disposable Hand Switch Pencils All CooperSurgical Disposable Hand Switch pencils are sold sterile and are for single patient use only. For the LEEP PRECISION Generator, use only CooperSurgical genuine Disposable Hand Switch Pencils (activated accessory with Finger Switch), which comply with IEC 60601-2-2: 4th edition. Genuine CooperSurgical Disposable Foot Switch-Operated Pencils and electrodes are available, sold sterile, and are for single patient use only. If you have any questions or require specific accessories, contact your CooperSurgical Representative. A variety of genuine CooperSurgical disposable electrodes and accessories are available. Use only cables approved by CooperSurgical. Regular inspection is required for accessories, including electrode cables, for damage to the insulation. If damage is found, the accessory should be replaced to assure safe operation. Only use accessories specifically made for the CooperSurgical LEEP PRECISION Generator that are specifically designed for the safe and proper operation of this unit. Use of alternate accessories or parts is not recommended as they have not been tested and verified and use may result in unsafe operation of this unit.

Section 12 Liability Statement CooperSurgical guarantees the safety, reliability, and performance of the LEEP PRECISION Generator only if the installation, recalibrations, and repairs are performed by personnel authorized by CooperSurgical and if it is used in compliance with given instructions in an area that meets all applicable IEC requirements.

Section 13 Warranty CooperSurgical, Inc., warrants that the LEEP PRECISION Generator (the “Product”) will be free from defects in materials and workmanship for a period of one (1) year from the original date of purchase. If the Product should become inoperable due to a defect in material or workmanship during this one year warranty period, CooperSurgical will, at its option, repair or replace the Product. This limited warranty does not include replacement or service to repair damage resulting from improper installation, external electrical fault, accident, disaster, use for a purpose other than that for which originally designed or indicated in this manual, negligence, modification, service or repair by personnel not authorized by CooperSurgical, or normal wear and tear, and also does not apply to disposable or single- or limited-use items or components. The sole and exclusive remedy under this limited warranty shall be repair or replacement as provided herein. The foregoing limited warranty states the sole warranty made by CooperSurgical with respect to the Product and all parts thereof, and is in lieu of any other warranty by CooperSurgical with respect to Product. COOPERSURGICAL NEITHER MAKES NOR GRANTS ANY OTHER WARRANTY, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THE PRODUCT, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL COOPERSURGICAL BE LIABLE FOR ANY DAMAGES ARISING OUT OF THE LOSS OF USE OF THE PRODUCT, OR ANY OTHER INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER OR NOT COOPERSURGICAL HAS ADVANCE KNOWLEDGE OF THE POSSIBILITY OF SAME. No person, agent, distributor, dealer, or company is authorized to change or modify the terms of this Limited Warranty. Only CooperSurgical is authorized to service or repair this unit. Do not disassemble the device. There are no user-serviceable components within the housing.

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Section 14 Service/Repair Poor performance by the machine will prove to be defective cords and/or connections. Check all cords and all connections periodically for signs of loose wires, worn insulation, or loose fit. On all models, check the connection from cords to console. Broken wires and connections can be detected by the use of a continuity meter. Only CooperSurgical is authorized to service or repair the LEEP PRECISION Generator. If repair is attempted outside the factory, the warranty will be considered void. CooperSurgical is not responsible for any injury resulting from repairs made by other individuals or organizations not certified by CooperSurgical. If a repair is needed, the equipment must be sanitized before it is returned to the factory and carefully packaged in a protective carton. On the note inserted in the box, please provide the following information: • Customer and contact information on the Repair Authorization Form (download from CooperSurgical website) or on company letterhead • Nature of the problem • Description of the item returned • Serial number (if applicable) All shipments must be prepaid. COD packages will not be accepted. Return carton to: CooperSurgical, Inc. Attention: Repair Department 95 Corporate Drive Trumbull, CT 06611 USA Phone: (203) 601-5202 • (800) 444-8456 Fax: (203) 601-4743

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