LEEP System 1000 Operating Manual Rev C March 2011

LEEP System 1000® Table of Contents Section

Content

1.

Professional Use Guide... 2

2.

System Features... 7

3.

Specifications... 9

4.

Electrosurgical Precautions... 11

5.

Placement of the Patient Plate or Dispersive Electrode... 13

6.

Foot Pedal Switch... 13

7.

Power Connection, Electrode Connection and Applying Power to Unit... 13

8.

Operation... 13

9.

Safety Circuits... 14

10.

Practical Suggestions... 14

11.

Cleaning... 14

12.

Periodic Safety Checks... 14

13.

Troubleshooting... 15

14.

Liability Statement... 16

15.

Warranty... 16

16.

Service and Repair... 16

17.

LEEP System 1000® EMC Compliance Information... 17

18.

Explanation of Symbols... 20

Manufactured by:

Page

Distributed by:

CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA CooperSurgical Customer Service: Phone: 203-601-5200 Phone: 800-243-2974 Fax: 800-262-0105

LEEP System 1000® • Operating Manual • English

1

Section 1

Professional Use Guide

IMPORTANT The user of this equipment, LEEP System 1000®, should be thoroughly trained in the techniques of Loop Electrosurgical Excision Procedures. This equipment has been designed for use with LEEP Electrosurgical Accessories. DO NOT use this equipment for any purpose other than that for which it has been designed. This manual contains information about the proper procedures for inspecting and preparing the equipment before its use, and its care and storage after use. This manual does not describe how an actual procedure is to be performed, nor is it meant to teach a beginner the proper technique or any of the medical considerations regarding the use of this equipment. CooperSurgical recommends that prospective user obtain appropriate training before using this equipment as improper use could be potentially hazardous to the patient and the user. This device SHOULD NOT be used without proper training. Training in the use of electrosurgical equipment should include: 1. A review of the published literature regarding the procedure of interest. 2. A review of the Loop Electrosurgical Excision Procedure (LEEP) Syllabus available from CooperSurgical. 3. Attendance at a course or courses offered by physicians experienced with the Loop Electrosurgical Excision Procedure. 4. Hands-on preceptor training from an experienced practitioner. Please read this entire manual carefully to become familiar with each of the controls and features before making any attempt to use the equipment clinically. Instructions contained in the operating manuals of any equipment to be used in conjunction with this equipment must be followed to avoid any possible hazard from incompatibility. Failure to thoroughly understand and follow the instructions given in this manual may result in serious injury to the patient and/or the operator. Failure to follow the instructions given in this manual may result in damage to or malfunction of this equipment. No long-term follow-up studies with this device have been performed as to recurrence rates. The effects of Loop Electrosurgical Excision Procedure on pregnancy outcome are not known. SAFETY PRECAUTIONS MUST ALWAYS BE EXERCISED WHEN USING ELECTRICAL EQUIPMENT TO PREVENT OPERATOR/PATIENT SHOCK, FIRE HAZARD AND EQUIPMENT DAMAGE. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. This device SHOULD NOT be used without proper training and preceptorship. If any questions arise regarding the information contained in this manual, the operation or safety of the equipment or service, please contact your local distributor.

1.1 Indications The LEEP procedure is indicated in the diagnosis and treatment of some Cervical Intraepithelial Neoplasia (CIN) in patients where there is:

2

•

Cytological or colposcopic suspicion of CIN 2 or worse (including micro-invasion)

•

Persistent CIN 1 (of more than 12 months duration)

•

CIN 1 where the likelihood of follow-up is low or when the patient requests treatment

•

A suspicion (cytological or colposcopic) of a glandular intraepithelial abnormality

LEEP System 1000® • Operating Manual • English (Continued)

•

A disparity between the cytological and colposcopic diagnoses

•

External anogenital lesion

•

Large vaginal intraepithelial neoplastic (VAIN) lesions

•

Cervical conization indications

1.2 Contraindications The following are typical contraindications for performing the LEEP procedure. It is imperative that the physician carefully weigh the risks and benefits of treatment versus non-treatment in contraindicated patients:

•

Pregnancy

•

Gross invasive carcinoma of the cervix

•

A bleeding disorder

•

Acute or active inflammation of the cervix, endometrium, fallopian tube, ovary or peritoneum (cervicitis, endometritis, tubo-ovarian inflammatory disease or pelvic inflammatory disease)

•

“Positive” endocervical curettage or a lesion in which the endocervical limit cannot be visualized colposcopically

•

Less than 3 months postpartum

•

Equivocal cervical abnormality

1.3 LEEP Procedure and Technique It is recommended that the patient be provided with a brief description of the procedure and the equipment that will be used (ACOG, CooperSurgical, and other professional organizations and equipment manufacturers have produced patient information brochures on the LEEP procedure that address many of the questions and concerns that your patients may have regarding the procedure).

1.4 Safety Precautions 1. This equipment should only be used by a thoroughly trained physician in an adequately equipped medical facility. 2. Replacement accessories and patient return pads should be kept on hand since defective active accessory or patient return pads can result in sub-standard performance of this equipment. 3. This equipment should only be connected to a properly grounded receptacle. NEVER use an adapter that defeats the ground of the built-in three (3) prong plug. 4. Care must be exercised when handling liquids around electrical equipment. DO NOT attempt to operate this equipment if liquids have spilled on the unit. DO NOT use flammable liquids around electrical equipment. 5. This equipment should never be used in conjunction with other equipment for which safety against leakage current has not been established. 6. When this equipment is operated: a.

A Patient Return Pad (dispersive pad) of adequate surface area MUST be properly attached to the patient or the risk of accidental burns will exist.

b.

The Patient Return Pad (dispersive pad) should be placed as close as possible to the site of use of the active accessory but MUST NEVER be placed so as to allow the patient’s heart to be in the pathway from the active accessory to the return electrode!

7. The user should thoroughly understand the principles and use of radio frequency (RF) current before using this equipment. This understanding is essential to avoid the hazard of shocks or burns to the user and/or the patient.

LEEP System 1000® • Operating Manual • English (Continued)

3

PROPER Generator RF current through patient to return pad

Active Electrode

Patient Patient return pad (Thigh)

Two conductor patient electrode continuity monitor

Grounded Metal Case

Patient may be grounded

IMPROPER Generator

Burn occurs at small grounded contact EKG

RF Isolated ESU

RF current flows from ground through EKG pad, through patient to return pad

Surgeon touches electrode to grounded object

IMPROPER RF current flows from electrode

Generator

Burn occurs at small grounded contact RF

EKG

Isolated or grounded ESU

Patient return pad touches grounded table

4

RF current returns to patient return pad via ground path

LEEP System 1000® • Operating Manual • English (Continued)

8. 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 unit may occur. 9. There are no user-serviceable parts within the housing. Repairs to this equipment should only be performed by authorized CooperSurgical service personnel. For service information, please contact your local distributor (see page 1).

1.5 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 Electrosurgical generators are designed to allow the controlled destruction of tissue and are inherently dangerous if operated improperly. REPORTED PROBLEMS DUE TO IMPROPER OPERATION DURING ELECTROSURGICAL PROCEDURES HAVE INCLUDED: • Inadvertent activation with resultant tissue damage at the wrong site and/or equipment damage. • Alternate current pathways resulting in burns where the patient or physician or assistant is in contact with exposed metal. • Explosions caused by electrosurgical sparking in a flammable gas mixture (i.e., explosive anesthetic gases and the inappropriate use of alcohol and other flammable liquids). • Perforation and massive hemorrhage. • A proper patient return pad pathway is extremely important during any monopolar electrosurgical procedure. Every effort must be made to ensure that throughout the electrosurgical procedure, an adequate surface area is provided and remains in proper contact with the patient to reduce the current density below a level that might cause inadvertent tissue damage where the patient return pad has been applied.

1.5.1

Setting the Controls

1.5.1.1

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 5 times) causes cellular structure to rupture, creating the clinical effect of “CUT”, with little or no hemostatic effect along the margin of the divided tissue. Delivery of short duration pulses of RF currents through a small electrode at appropriate power levels can cause heating of intracellular fluids at a more gradual pace. This allows evaporation of these fluids without rupturing the cellular structure, creating the clinical effect of desiccation, or “COAG”, without the division of tissue. By varying the pulse to an intermediate duration, it is possible to get a clinical effect that combines, or “blends”, the clinical characteristics of CUT and COAG yielding the effect referred to as “BLEND”, where tissue is divided with a desirable amount of hemostatis along the margins of the divided tissue. The electrosurgical effect may vary throughout the procedure, requiring the operator to adjust the relative power setting of the generator.

LEEP System 1000® • Operating Manual • English (Continued)

5

1.5.1.2

Select the output mode (i.e., “CUT”, “BLEND”, or “COAG”) by pushing the corresponding buttons.

Output Mode

Waveform Description

General Effect

CUT

Continuous 450 kHz sinusoid with minimal modulation

Cutting without Hemostatis

BLEND

Interrupted 450 kHz sinusoid intermediate duty cycle

Cutting with minimal Hemostatis

COAG

Bursts of 450 kHz sinusoid short duty cycle

Coagulation without Cutting

1.5.1.3

Set the level of output power (confirmed on the digital display) by using the output power selector buttons as desired.

WARNING The degree and speed of electrosurgical effect is largely dependent on Current Density at the point of contact of the active electrode. Loop electrosurgical excision procedure electrodes from other manufacturers may vary in the diameter thickness, size and configuration of the cutting wire. This may result in SIGNIFICANT changes in the electrosurgical effect at a given output power level setting. The use of CooperSurgical LEEP Electrodes is recommended. 1.5.1.4

1.5.2

If the use of other output modes is anticipated, repeat steps #1 and #2 as desired. The output power level settings selected for each output mode will be retained as long as the unit remains ON.

Guidelines for Power Settings

The following guidelines for power settings may vary due to the technique, clinical circumstances, accessory style, cutting wire diameter, size, configuration and user preference. Recommended Power Settings (Watts) for the CooperSurgical LEEP System 1000 Electrodes Style

Loop Width (cm)

Ball Electrodes

1.0

1.5

2.0

CUT*

-

-

-

BLEND

22–36

30–40

COAG

-

-

Needle Electrodes Macro

Micro

-

-

14–24

34–36

-

-

-

-

40–56+

30–36

-

NOTE

* If the cut mode is desired, use the recommended settings for the blend mode.

+ The power setting can be increased beyond 56 to coagulate any bleeding points as required.

The above settings are for reference only and can be varied based on specific situations and the experience of the operator. REMEMBER, THIS IS NOT AN ATTEMPT TO TEACH ELECTROSURGICAL TECHNIQUE. The practitioner who lacks experience should not attempt the procedures described below based solely on this information; instead, the skills required should be acquired in the time-honored preceptor manner. Call your local distributor (see page 1) for information on courses that offer instruction on the proper use of electrosurgical generators and accessories. NOTE: The best initial effect is accomplished with the cutting wire in only light contact with tissue. Tight pressure may cause desiccation of the tissue and will delay the start of the cutting effect.

6

LEEP System 1000® • Operating Manual • English (Continued)

IMPORTANT The initial use of any electrosurgical generator always involves some degree of “trial and error”. This is true even when only changing from numbered dials to digital display models within the same manufacturer’s product line. As with any other therapeutic device, it is very helpful to experiment IN VITRO or on animal sample tissue before using any electrosurgical generator or methods which are not familiar. The microprocessor control system of this unit was developed specifically to provide the best possible performance for loop electrosurgical excision procedures. By exhibiting patience and following the guidelines offered, the practitioner should easily become familiar with the performance characteristics of the LEEP System 1000.

1.5.3

Thermal Effects on Tissue Treated with Loop Electrodes

Thermal effects on tissue specimens may include (1) thermal coagulation injury of the cervix, up to one-third the thickness of normal epithelium of the cervix, (2) fragmentation of squamous epithelium of the cervix attributable to long exposure periods along the excision site that allows heat to dissipate laterally, and (3) partial coagulation of the endocervical epithelium because of lateral radiation of heat. Therefore, the loop electrosurgical excision procedure (LEEP) may produce thermal effects at the periphery of the excised tissue and may make histopathologic interpretation difficult or impossible and not allow accurate diagnosis and need for further treatment.

Section 2

System Features

•

Microprocessor controlled for increased precision, accuracy, repeatability, and safety.

•

Adequate power for all LEEP monopolar electrosurgical procedures.

•

Accurate selection of discrete power levels.

•

Digital display of output power levels.

•

Choice of radio frequency wave forms including CUT, BLEND, and COAG to accommodate subtle differences in technique and accessory performance.

•

Patient plate continuity monitoring with audible alarm.

•

Distinct audible tones for CUT/BLEND modes and COAG mode with associated MODE light.

•

Fully regulated isolated output power.

•

Meets or exceeds IEC 601-2-2, second edition.

•

Non-electric pneumatic foot pedal to maximize safety.

•

Choice of reusable or disposable patient plate.

•

Choice of reusable or disposable handpiece.

•

Choice of reusable or disposable electrodes.

•

Output power safety audible alarm with automatic power shut off.

•

Class 1, type BF, protected for use with defibrillator.

•

Membrane switching to maximize cleanliness and ease of use.

LEEP System 1000® • Operating Manual • English (Continued)

7

5

1

2

6

7

8

10

9

3

4

CONTROLS

1. Main switch

7. Pure cut and blend light (yellow)

2. Socket for pedal switch

8. Mode control:

3. Socket for active electrodes

Pure Cut Blend Cut Coag

4. Socket for neutral electrode 5. Warning light of neutral electrode alarm (red) 6. Coagulation light (blue)

9. Power control 10. Display

Classification I Type BF protected against defibrillator effects Floating output circuit Cautions, consult this manual for safety precautions Pedal connection Active handle connection Patient plate connection High voltage 45 °C 10 °C

8

Temperature limitation

LEEP System 1000® • Operating Manual • English (Continued)

Section 3

Specifications

Meets or exceeds IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 specifications. Product conforms to the Medical Device Directive 93/42/EEC. ELECTRICAL INPUT VOLTAGE: CURRENT: LOW FREQUENCY LEAKAGE: FUSES: POWER CORD:

95 - 135 VAC 50/60 Hz 190 - 250 VAC 50 Hz 2.3 amps max. 2.3 amps max. Less than 50 micro-amps Less than 50 micro-amps 2.5 amps, 250V, T type 1.6 amps, 250V, T type American Cord Set, Hospital Grade, NEMA 5-15P/IEC 320 female, 250 cm long

ENVIRONMENTAL CONDITIONS (Usage Shipping and Storage) Environmental Temperature: Relative Humidity:

Between 10 °C and 45 °C (50 °F and 113 °F) Between 30% and 75%

PHYSICAL Dimensions:

305 mm x 267 mm x 115 mm (12 in. x 15.5 in. x 4.5 in.)

Weight:

7.250 Kg (16 pounds)

ELECTROSURGICAL OUTPUT RF Output Frequency: 450 kHz RF OUTPUT POWER:

Volts p-p Max (open circuit)

Duty Cycle

Crest Factor

CUT

0-100 watts RMS*

830

---

1.4

BLEND

0-100 watts RMS*

1200

60%

2.0

COAG

0-80 watts RMS*

3800

10%

5.5

NOTE: *Stable to >800 ohms (calibration at 500 ohms) RF ISOLATION: Less than 150 milli-amps at 200 ohms CLASSIFICATION... I-Type BF OUTPUT CIRCUIT... Floating output. Protected against the effects of the defibrillator. WORKING MODE... Discontinuous maximum duty cycle: 10/30 sec. COOLING... Convection cooling without fan CONTROL... Foot pedal operated (pneumatic) with audible signals and mode lights AUDIBLE SIGNALS AND LIGHTS FOR OPERATION AND ALARM: MAIN... Green light ALARM, PATIENT PLATE CONTINUITY . . Low pitch intermittent audible alarm - red light ALARM, OUTPUT POWER... Higher pitch intermittent audible alarm CUT AND BLEND MODES... Low pitch audible signal - yellow light COAGULATION MODE... High pitch audible signal - blue light NOTE: Specifications subject to change.

LEEP System 1000® • Operating Manual • English (Continued)

9

OUTPUT POWER AT 500 OHMS PURE CUT...100 W RMS (open circuit 830 Vp-p; crest factor 1.43) Waveform: sinusoidal at 450 kHz BLEND CUT...100 W RMS (open circuit 1200 Vp-p; crest factor 2) Waveform: sinusoidal at 450 kHz Duty cycle: 60% COAGULATION...80 W RMS (open circuit 3800 Vp-p; crest factor 5.5) Waveform: sinusoidal at 450 kHz Duty cycle: 10% Output Power Diagrams according to PAR.6.8.3 (IEC 601-2-2) Tolerance: 20% according to PAR.50.2 (IEC 601-2-2)

Power (500 ohm) (W) 100 75

PURE CUT BLEND CUT

50 25

Setting 25

50

75

100

60

80

Power (500 ohm) (W) 80

COAGULATION

60 40 20

Setting 20

10

40

LEEP System 1000® • Operating Manual • English (Continued)

Power 1 PURE CUT - POWER 100%

2 PURE CUT - POWER 50% Impedance (ohm)

Power 1 BLEND CUT - POWER 100%

2 BLEND CUT - POWER 50% Impedance (ohm)

Power 1 COAGULATION - POWER 100%

2 COAGULATION - POWER 50% Impedance (ohm)

Section 4

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 System and thoroughly understand the principles and use of radio frequency (RF) electrosurgical systems. WARNING: Electrosurgery uses radio-frequency energy to cut and coagulate tissue. Due to the sparking and heat associated with electrosurgery do not use with flammable anesthetics, or other flammable gases, near flammable fluids or objects or with oxidizing agents. •

DO NOT use electrosurgery in the presence of flammable gases, flammable liquids, or flammable objects in oxygen enriched atmospheres, nitrous oxide (N2O) atmosphere or in the presence of other oxidizing agents.

•

Prevent accumulation of oxygen, nitrous oxide (N2O), and flammable gases, under surgical drapes, or within the area where electrosurgery is performed, and it should be avoided in case of thorax or head operations unless safely aspirated.

•

Verify that all oxygen connections are leak-free before and during the use of electrosurgery.

•

DO NOT use electrosurgery in the presence of naturally occurring flammable gases which may accumulate in body cavities such as the bowel.

LEEP System 1000® • Operating Manual • English (Continued)

11

•

DO NOT use electrosurgery in the presence of flammable liquids, such as skin prepping agents. Avoid pooling of flammable liquids near the electrosurgery site or in human body cavities such as the umbilicus or vagina.

•

DO NOT place the electrosurgery active electrode near or in contact with flammable materials, such as cotton, wool or gauze. The active electrode is hot from use and can cause fire.

•

It is possible that the radio frequency can interfere with the electronic circuitry in the pacemaker. To reduce the risk locate the patient return electrode as close as possible to the treatment site and ensure that the current path between the surgical site and the patient return electrode is as far removed from the heart as possible. For the gynecology procedures locate the patient return electrode on the patient's upper thigh or under buttocks. Always monitor pacemaker patients during surgery. In case of doubt ask the pacemaker manufacturer and/or cardiology department.

•

In case of loss of power, turn the system off.

•

The possibility exists that the radio frequency can interfere with other medical equipment when the electrosurgical system is operating. To reduce the interference, physically separate the device, utilize different electrical outlets that are hospital grounded, do not allow cables to come in contact with each other, and utilize shielded devices where possible.

•

The fixed output power level should be adjusted to the lowest power setting that will successfully complete the procedure. Refer to the following recommended power settings for the CooperSurgical LEEP System 1000 Electrodes.

Recommended Power Settings (Watts) for the CooperSurgical LEEP System 1000 Electrodes Style

Loop Width (cm) 1.0

1.5

2.0

CUT*

-

-

-

BLEND

22–36

30–40

COAG

-

-

Ball Electrodes

Needle Electrodes Macro

Micro

-

-

14–24

34–36

-

-

-

-

40–56+

30–36

-

The above power settings are for reference only and can be varied based on specific situations and the experience of the operator. NOTE:

* If the cut mode is desired, use the recommended settings for the blend mode. + The power setting can be increased beyond 56 to coagulate any bleeding points as required.

12

•

Skin to skin contact, for instance between the patient's arm and body, should be avoided by the placement of an appropriate separating device such as two to three inches of dry gauze. This will reduce the potential for alternate site burns.

•

If monitoring, stimulation, imaging or similar devices are used simultaneously with electrosurgery the monitoring electrodes must be placed as far as possible from the electrosurgery site and the patient return electrode. Position the patient return electrode close to the electrosurgery site, for example, on the thigh when treating the cervix. NOTE: Monitoring needle electrodes are not recommended.

•

The electrical cord of the generator should be connected to a properly grounded receptacle. Extension cords and/or adapter plugs should not be used.

•

The connecting cables to the electrosurgery electrodes should be placed so that they do not come in contact with the patient, other cables, or cross each other.

•

Remove any metal items from the patient: for example, rings, chains, etc.

•

Use accessories supplied by CooperSurgical; they are specifically designed for the LEEP System 1000.

•

Do not use old or worn accessories.

LEEP System 1000® • Operating Manual • English (Continued)

Section 5

Placement of the Patient Plate or Dispersive Electrode

When using an electrosurgical system, it is very important that all the current delivered to the patient returns correctly to the unit via the dispersive patient plate only.

•

The patient must be positioned correctly on the operating table. The patient and operator must not come in contact with any metal conductive surfaces.

•

The patient plate must securely contact a vascular area close to the operating site. For a gynecology procedure the preferred sites are the patient's thigh (disposable adhesive pads) or under the patient's buttocks (reusable metal plate). The contact area must be clean, free of body lotions, shaved, and massaged for good circulation. The contact area of the patient plate must be maximized and frequently checked for uniform contact during the procedure, especially if the patient has moved or if liquids have contacted the patient plate. A CONDUCTIVE GEL IS RECOMMENDED. The patient plate MUST NEVER be placed so as to allow the patient's heart to be in the pathway from the active electrode.

•

Power delivery to the operative site may be decreased appreciably if alternate pathways exist; for example, through the metal operating table, crossed handpiece/patient plate cables, etc.

Section 6

Foot Pedal Switch

Connect the foot pedal switch to the socket (2) without activating the pedal, and tighten the threaded plug. This is an air (pneumatic) operated control. There is no electric current, offering maximum safety.

Section 7

Power Connection, Electrode Connection and Applying Power to Unit (Refer to the diagram on page 8)

A.

Check that power input corresponds to the technical data on the back of the unit. Plug the detachable cord into the back of the unit. Plug the power cord into the appropriate grounded wall outlet, ensuring that the ESU on/off switch is in the “OFF” position.

B.

Connect dispersive patient plate to the socket (4).

C.

Connect the active electrode handpiece to the socket (3) and tighten electrode of choice in the handpiece.

D.

Turn ON the unit by the power switch (1). The unit automatically performs a SELF TEST that checks RAM memory, EPROM memory, supply voltage, signal modulation and the following displays; function selector green lights, digital display, cut and coagulant yellow light, coagulation blue light, and the audible signal. When the unit passes SELF TEST the display will show current software revision i.e., r2A, r2B for several seconds then goes blank.

Section 8

Operation

Setting Power (refer to diagram on page 8) A.

Control (8) sets the cut mode power output. The unit automatically powers up to cut mode when turned ON. The top LED lights on the selector (8) and control (9) sets the power.

B.

Control (8) selects blend mode (center LED) and control (9) sets the power.

C.

Control (8) selects coagulation mode (bottom LED) and control (9) sets the power.

Power settings are stored when the system is ON and will appear automatically on the display (10) according to the selection of power mode by the control (8) during the procedure. Power may be changed at any time during the operation, except when the unit is activated by the foot pedal. At the end of the procedure turn the system OFF, and safely store the equipment and accessories. Power will reset to zero.

LEEP System 1000® • Operating Manual • English (Continued)

13

Section 9

Safety Circuits

The LEEP 1000 is equipped with two (2) safety circuits. The first one checks the dispersive patient plate connection. The second one turns off the power in case of an internal failure. When activating the unit by the foot pedal, a power delivery higher than the one selected will stop power delivery and at the same time give an audible signal similar to the patient plate alarm, but at a higher frequency.

Section 10 Practical Suggestions To optimize the performance when using an electrosurgical unit, the active electrode must be kept clean and use the lowest possible power setting required. Some sparks or superficial carbonization of the tissue may occur and the delivered power may decrease as a result of the electrical insulation caused by the tissue charring. Too high of a power setting results in a shorter surgical procedure, but may cause discharges and/or superficial carbonization, sparking, arcs, etc.

Section 11 Cleaning The unit may be cleaned with mild soap solution, but be sure that fluid does not enter the system. Wipe dry.

Section 12 Periodic Safety Checks The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.

•

Inspect the equipment and accessories for mechanical and functional damage.

•

Inspect the relevant safety labels for legibility.

•

Inspect the fuse to verify compliance with rated current and breaking characteristics.

•

Inspect acoustical and visual alarms/displays.

•

Verify that the device functions properly as described in the instructions for use.

•

Verify that the device shuts down the applied part circuit if the neutral electrode is disconnected.

•

Test the protection earth resistance according to IEC 601-1/1988: Limit 0.2 ohm.

•

Check that the output power is within tolerance versus the output control setting at a specified load resistance.

•

Check the power output at full and half setting of the output control over the range of load resistance as specified in the instructions for use (max. deviation is ± 20%).

•

Test the enclosure leakage current according to IEC 601-1/1988: Limit 100µA.

•

Test the leakage current according to IEC 601-1/1988: Limit 100µA (BF).

•

Test the patient leakage current under single fault condition with main voltage on the applied part according to IEC 601-1/1988: Limit: 5mA (BF).

The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.

14

LEEP System 1000® • Operating Manual • English (Continued)

Section 13 Troubleshooting In the event of a failure during SELF TEST the display will show one of the error codes listed below: ALARM SIGNALS PROBLEM RAM Memory (during self-test phase)

AUDIBLE TONE 1 kHz 100ms ON 250ms OFF

DISPLAY “Er0”

EPROM Memory (during self-test phase)

1 kHz 100ms ON 250ms OFF

“Er1”

Signal Modulation (during self-test phase)

1 kHz 200ms ON 250ms OFF

“Er2”

Signal Modulation (during activation phase)

1 kHz 40ms ON 60ms OFF

“Er2”

Supply Voltage (during self-test phase)

1 kHz 100ms ON 250ms OFF

“Er3”

Supply Voltage (during activation phase)

1 kHz 40ms ON 60ms OFF

“Er3”

Power Output (during activation phase)

1 kHz 100ms ON 250ms OFF

“Er5”

Foot Pedal Circuit (during self-test phase)

1 kHz 100ms ON 250ms OFF

“Er6”

Microcontroller Power Supply

1 kHz 100ms ON 250ms OFF

“Er7”

Dispersive Electrode

1 kHz 80ms ON 125ms OFF

“nP” & Red Light

A. If upon completion of Self Test the unit display reads Er0, Er1, Er2, Er3, Er5, Er6 or Er7 the unit must be returned to your local distributor for repair (see page 1). B. If upon completion of Self Test or if the unit stops functioning and the display reads nP and the red warning light is on, check the dispersive patient plate to insure that it is properly connected to the LEEP System 1000. C. If, following correct set-up of the system, it does not operate, works in an intermittent way, or stops working after a few seconds (without an audible signal), check for correct connection of pedal and its condition. The pedal is pneumatic, so even a slight leak can cause a performance problem. Proceed as follows: 1. Tighten the threaded plug into the foot pedal socket. 2. Then, push the pedal hard repeatedly to detect possible breaks in the tubing or in the pedal. D. If the unit, correctly connected, appears to deliver a lower power output than usual, check: 1. The dispersive patient plate for complete contact (refer to dispersive plate sections). 2. The condition of active electrodes (refer to “Section 10, Practical Suggestions”). 3. The condition of the handpiece (cable continuity, contact of the electrode in the handpiece and the connector) by moving the cable and the connector and electrode to detect possible breaks and poor contact in the socket of the system. E. The LEEP System 1000 has a thermal protection circuit which will shut the unit off when internal operating temperatures exceed safe limits. Should the unit stop functioning with no alarm signal, assure that the system has adequate ventilation and that you have not exceeded the recommended duty cycle of 10/30 seconds. Should the thermal protection circuit be activated under normal operating conditions the system must be returned to your local distributor (see page 1) for servicing. LEEP System 1000® • Operating Manual • English (Continued)

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Section 14 Liability Statement CooperSurgical guarantees the safety, reliability and performances of the LEEP System 1000 only if the installation, recalibrations and repairs are performed by personnel authorized by CooperSurgical and if the unit is used in compliance with given instructions in an area that meets all the applicable IEC requirements.

Section 15 Warranty CooperSurgical, Inc. warrants that the LEEP System 1000 (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 (1) 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 manal, 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 EXPRESS 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.

Section 16 Service and Repair No Customer Serviceable Parts Only CooperSurgical Inc. is authorized to service or repair this unit. If repair is attempted outside the factory, the warranty is considered void. CooperSurgical is not responsible for any injury resulting from repairs made by other individuals or organizations not certified by CooperSurgical Inc. If a repair is needed, equipment must be sanitized before it is returned to the factory and carefully packaged in a protective carton. All shipments must be pre-paid. COD packages will not be accepted. Return carton to:

CooperSurgical Inc. Attention: Repair Department 95 Corporate Drive • Trumbull, CT 06611 USA Phone: (203) 601-5200 • (800) 444-8456 Fax: (203) 601-4743

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LEEP System 1000® • Operating Manual • English (Continued)

Section 17 LEEP System 1000 EMC Compliance Information Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The LEEP System 1000 is intended for use in the electromagnetic environment specified below. The customer or the end user of the LEEP System 1000 should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic discharge (ESD)

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

Electrical fast transient/burst

± 2 kV for power supply lines

± 2 kV for power supply lines

IEC 61000-4-4

± 1 kV for input/output lines

± 1 kV for input/output lines

Surge

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

IEC 61000-4-2

IEC 61000-4-5

Voltage dips, <5% UT* short interruptions (>95% dip in UT*) and voltage for 0.5 cycle variations on 40% UT* power supply (60% dip in UT*) input lines for 5 cycles IEC 61000-4-11 70% UT* (30% dip in UT*) for 25 cycles

<5% UT* (>95% dip in UT*) for 0.5 cycle

<5% UT* (>95% dip in UT*) for 5 seconds

<5% UT* (>95% dip in UT*) for 5 seconds

Power frequency 3 A/m (50/60 Hz) magnetic field

40% UT* (60% dip in UT*) for 5 cycles 70% UT* (30% dip in UT*) for 25 cycles

3 A/m

Electromagnetic Environmental guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. If the user of the LEEP System 1000 requires continued operation during power mains interruptions, it is recommended that the LEEP System 1000 be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-8 NOTE: * UT is the AC mains voltage prior to application of the test level.

LEEP System 1000® • Operating Manual • English (Continued)

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Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environmental – guidance Portable and mobile RF communications equipment should be used no closer to any part of the LEEP System 1000, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF 3 Vrms 3V IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80 MHz to 2.5 GHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequencyb. Interference may occur in the vicinity of equipment marked with the following symbol:

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NOTE 1

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LEEP System 1000 is used exceeds the applicable RF compliance level above, the LEEP System 1000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the LEEP System 1000.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

LEEP System 1000® • Operating Manual • English (Continued)

Recommended separation distance between portable and mobile RF communications equipment and the Model LEEP System 1000. The LEEP System 1000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LEEP System 1000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LEEP System 1000 as recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

Rated maximum output power of transmitter

Meters 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.1167

0.1167

0.2333

0.1

0.3689

0.3689

0.7379

1

1.1667

1.1667

2.3333

10

3.6894

3.6894

7.3789

100

11.667

11.667

23.333

Watts

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output rating of the transmitter in watts (W) according to the transmitter manufacturer. For the LEEP System 1000 V1 = 3 Vrms E1 = 3 V/m NOTE 1 NOTE 2

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

LEEP System 1000® • Operating Manual • English (Continued)

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