LEEP PRECISION Integrated System Operating Manual Rev A April 2017

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LEEP PRECISIONTM Integrated System, 120 VAC and 230 VAC Models LP-10-120 and LP-10-220

Table of Contents Section

Content

Page

1. 1.1 1.2 1.3 1.4

Description ... 5 Introduction... 5 LEEP PRECISION Generator Description... 5 LEEP PRECISION Smoke Evacuator Description... 5 LEEP PRECISION Cart (with attached LEEP PRECISION Integration Unit) Description... 5

2. 2.1 2.2 2.3 2.4 2.5 2.6 2.7

Unpacking and Assembly ... 6 Unpacking Shipping Carton... 6 Unpacking and Installing the LEEP PRECISION Smoke Evacuator... 7 Unpacking and Installing the LEEP PRECISION Generator... 7 Installing the Filters and Tubing to the LEEP PRECISION Smoke Evacuator... 8 Connecting the LEEP PRECISION Integrated System to the Wall Outlet... 8 Installing the Foot Pedal Switch on the LEEP PRECISION Generator... 9 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. 5.1 5.2 5.3 5.4 5.5 5.6

Professional Use Guide ... 14 LEEP PRECISION Cart Use... 14 Indications... 14 Contraindications... 15 LEEP Procedure and Technique... 15 Safety Precautions... 15 Electrosurgical Procedures... 16

6.

Electrosurgical Precautions ... 19

7.

LEEP PRECISION Patient Return Electrode ... 21

8. 8.1 8.2 8.3 8.4 8.5 8.6 8.7

Turning on the LEEP PRECISION Integrated System ... 22 Practice... 22 The Power Setting... 24 Cutting Techniques... 24 Criteria of a Good Cutting Technique... 25 Coagulating... 25 Coagulating Technique... 25 Technique Guidance... 26

9.

Powering Down the LEEP PRECISION Integrated System ... 26

10.

Maintenance ... 27

11. 11.1

Accessories ... 27 Disposable Hand Switch Pencils... 27 3

Table of Contents (continued) Section

Content

Page

12.

Troubleshooting ... 28

13. 13.1 13.2 13.3 13.4 13.5 13.6

Specifications ... LEEP PRECISION Integrated System... LEEP PRECISION Generator... LEEP PRECISION Smoke Evacuator... LEEP PRECISION Cart with Integration Unit... Power Output Characteristics... Power Output at Various Load Resistance...

29 29 29 30 30 31 32

14. 14.1 14.2 14.3 14.4 14.5 14.6 14.7

LEEP PRECISION Smoke Evacuator ... System Description... Initial System Setup... ULPA Filter Installation... Operating Instructions... Maintenance Procedures... Cleaning Procedures... Cautions...

33 33 33 33 33 34 34 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: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com International Phone: (203) 601-9818 Fax: (203) 601-4747

EMERGO EUROPE Prinsessegracht 20 2514 AP The Hague The Netherlands CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA

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Section 1 Description 1.1 Introduction

The LEEP PRECISIONTM Integrated System, which includes the following components: 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

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 filtration system is used to remove airborne particulate plumes produced during office 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.)

5

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.

LEEP PRECISION Smoke Evacuator

LEEP PRECISION Generator (below)

LEEP PRECISION Cart

Photo A

6

Isometric View Back View LEEP PRECISION Cart Main Power Switch

LEEP PRECISION Generator

To the outlet

 Connector for the LEEP PRECISION Smoke Evacuator

(A)

Handle Bar Hooks (1 of 4)

Shelves

Velcro for the LEEP PRECISION Smoke Evacuator

LEEP PRECISION Smoke Evacuator plug located here in the rear

Locking Casters (wheels)

 LEEP PRECISION Integration Unit



LEEP PRECISION Smoke Evacuator

(B)

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) fits into the receptacle of the LEEP PRECISION Generator. Gently press the LEEP PRECISION Generator into place.

7

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).

Photo B

2.4.2 Installing the Pre-Filter

 repare the unit for use by inserting a clean, disposable Pre-Filter P (Single Patient Use) onto the ULPA Filter Cylinder (see Photo C). Be sure the device is firmly seated. Photo C 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).

Photo D

For procedures requiring open-area plume removal (i.e., external lesions)  ssemble the sterile Disposable Evacuation Tubing (REF 6084) directly into the top of the Pre-Filter. A 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 12 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 13 on the LEEP PRECISION Integration Unit and then into a hospital-grade grounded wall outlet to obtain power [refer to (A) in Figure 1].

8

12 13 14

2.6 Installing the Foot Pedal Switch on the LEEP PRECISION Generator Connect the Foot Pedal Switch to the socket 5 shown in Figure 2 if foot control is desired.

7

3 4

1 2

8 5

Figure 2

2.7 Installing the Active and Dispersive Electrodes 2.7.1 Placement of the Active Electrode

• Connect the Active Electrode to socket 7 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 7 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 8 . 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.

9

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 10

RF current returns to Patient Return Electrode via ground path

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:

­­

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 .

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

Classification Model LEEP PRECISION Generator

Safety Class

Type

I

BF

•

Do not get fluid 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 classified as normal equipment (IPX0) according to protection against ingress of water.

11

Section 4 F  ront and Rear Panels of the LEEP PRECISION Generator and Integration Unit (Colored, numbered boxes are also located later in this manual.)

4.1 Front Panel of the LEEP PRECISION Generator (Cart not shown)

7

3 4

1

8

2 5 1a-1g

Figure 6 (Front Panel)

Indicator Lights 2

Controls 1 Operator Pushbuttons 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

WAIT

= Red

CUT

= Yellow

BLEND = Yellow COAG = Blue

Power Indications 3 Digital LED Display

Acoustical Piezo Annunciator (internal)

Foot Switch Socket 5 A/C Power (rear panel) 6

Pilot Lights 4

Active Electrode Socket 7 Dispersive Electrode Socket 8

PATIENT PAD LOOSE

Remote Pencil Buttons (not shown)

R/F LEAKAGE ERROR SYSTEM READY R/F ON

* 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 five (5) seconds after the button is released. Most purge operations (removing excess smoke) take only a few seconds.

12

4.2 Rear Panel of the LEEP PRECISION Generator

9

6

10

11

Figure 7 (Rear Panel)

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

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

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)

4.3 LEEP PRECISION Integration Unit LEEP PRECISION Integration Unit Main Power Switch (ON/OFF) 12

12

 he Power cord connects here 13 and other end goes to T the wall outlet

13

Figure 8

14

 he Connector with Cord 14 is permanently mounted T on the LEEP PRECISION Integration Unit; the other end plugs into the LEEP PRECISION Smoke Evacuator

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

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

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5.3 Contraindications

• Pregnancy • Known or suspected cervical changes secondary to DES (diethylstilbestrol) 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 • 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 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. 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).

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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 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. 5.6.1 Electrosurgical Tissue Effect Delivery of continuous sinusoid waveform currents through a small electrode at appropriate power levels can cause rapid heating of the intracellular fluids in the cells in close proximity to the electrode, turning these fluids to steam. The significant increase in volume (approximately five 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 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, 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

5.6.2 Select the Output Mode (i.e., CUT, BLEND or COAG by Pushing NOTE: Numbers in blue boxes refer the Corresponding Button 1 e, f , or g) 

to those component parts in Figure 6.

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

5.6.3 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. 5.6.4 A  ttendant 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 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

17

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 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 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, 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 difficult or impossible and, therefore, may not allow accurate diagnosis and may obscure the need for further treatment.

18

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 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.

19

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 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 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 the 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.

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