VERSAPOINT User Manual Rev G March 2010

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TABLE OF CONTENTS

SECTION 1 INTRODUCTION

PAGE

Overview of Endoscopic Surgery ...1-1 Comparison with Conventional Electrosurgery ...1-1 System Description...1-2 Indications for Use...1-4 Contraindications for Use ...1-4

2

PATIENT AND OPERATING ROOM SAFETY General...2-1 Fire/Explosion...2-3 Before Surgery...2-3 EMC Precautions ...2-4 During Surgery ...2-5 Adverse Effects...2-6

3

INSTALLATION Responsibility of the Manufacturer...3-1 Generator Power Requirements ...3-1 Grounding of the Generator ...3-1 EMC Considerations...3-2

4

GENERAL INFORMATION Generator Indicators and Displays ...4-1 Generator Output Mode, Power Controls and Display...4-1 Generator Indicators Set-up and Malfunction Displays ...4-2 Generator Connectors and Receptacles ...4-4

5

BEFORE SURGERY Power up the Generator...5-1 Select the Appropriate Electrode(s) for the Procedure ...5-2 Hysteroscope and Ancillary Equipment Compatibility...5-2 Steam Sterilize the Connector Cable ...5-2

6

DURING SURGERY Active Electrode Accessories ...6-1 Recommendations During Surgery ...6-1 Set up the Generator for Surgery...6-3

7 AFTER SURGERY ...7-1 8 OPERATING ROOM TROUBLESHOOTING ...8-1 9 PERFORMANCE SPECIFICATIONS ...9-1 10 ERROR AND FAULT CODES ...10-1 11 EXPLANATION OF SYMBOLS ...11-1 12 PERIODIC EQUIPMENT SAFETY CHECKS ...12-1 13 LIMITED WARRANTY ...13-1

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Section 1

INTRODUCTION This user’s manual will familiarize you with the controls and output functions available from your GYNECARE VERSAPOINT Hysteroscopic generator and instruct you on the proper use of the equipment.

OVERVIEW OF ENDOSCOPIC SURGERY An endoscope is an instrument routinely employed to visualize and access the interior of various body cavities for the purposes of both diagnostic and surgical procedures. When the endoscope is inserted through a natural body opening, such as the cervical canal or urethra, the instrument commonly includes one or more integral working channels, as well as conduits for the passage of gas or liquid required to distend the body cavity. Commonly referred to as underwater surgery, liquid distention is usually the preferred method in hysteroscopic, urological and arthroscopic endoscopy. The overall diameter of the endoscope dictates the ease with which dilation of the cervical canal or urethra can be performed under local anesthesia in an outpatient or office setting. Outpatient or day case surgery provides for cost effective healthcare management; a factor which has driven a progressive reduction in the diameter of operating endoscopes, particularly hysteroscopes. The reduction in overall diameter has constrained the size of the working channel. Consequently, this has limited the scope of tissue effect modalities compatible with the new generation endoscopes. Other than the use of mechanical devices such as biopsy forceps and miniature scissors, it is the delivery of laser energy through fine optical fibers which has to date provided the most effective modality. Clearly, one of the main drawbacks of lasers is their expense, installation and maintenance; the GYNECARE VERSAPOINT Hysteroscopic system has been developed as an alternative endoscopic energy source and delivery system to support the expansion of outpatient services. Electrosurgery is a familiar tool widely employed in surgical practice for the last 50 years. GYNECARE VERSAPOINT brings about a level of tissue performance that combines the most desirable elements from the two conventional output modalities of bipolar and monopolar electrosurgery in specific system configurations for advanced endoscopic surgery. The GYNECARE VERSAPOINT device provides a form of electrosurgery specifically developed for underwater endoscopic applications. It appears and performs like a monopolar device, provides laser-like tissue vaporization, yet retains all the inherent safety features of bipolar electrosurgery.

COMPARISON WITH CONVENTIONAL ELECTROSURGERY Conventional bipolar electrosurgery requires both “poles” of the electrode contact tissue to complete the electrical circuit and produce a tissue effect. Typically, these electrodes do not operate effectively while immersed in a conductive irrigating solution such as normal saline. The GYNECARE VERSAPOINT system utilizes the fact that the irrigating solution is conductive to stagger the electrode arrangement at the tip so that the “return” electrode is remote from tissue and mounted on the shaft of the instrument. To some extent, this is similar to a monopolar arrangement, in that the return electrode is remote from the tissue contact, or active, electrode. In this instance, however, the proximity of the return electrode to the working tip and the fact that no tissue, other than that contacting the active electrode is involved in the electrical circuit, preserves the recognized safety features of bipolar electrosurgery. Similarly, this arrangement may avoid a lot of the problems commonly encountered

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when using bipolar electrosurgery: orientation of the electrode to tissue, visualization of the working tip, tissue sticking and limited power delivery. One of the additional features of being able to both deliver higher powers through the electrode and the ability to make the active electrode much smaller than the return electrode, allows the system to produce laser-like tissue vaporization by creating a vapor pocket around the active electrode. This effect can be achieved with monopolar electrosurgery but at very high power levels and only in the presence of a non-electrolyte irrigating solution, both aspects of which have recognized complications and safety concerns. In order for the GYNECARE VERSAPOINT system to produce this effect, the generator has integral controls and features to both initiate and sustain the vapor pocket around the active electrode. Depending on the electrode configuration, the electrode itself also has specific features required to sustain the vapor pocket.

SYSTEM DESCRIPTION The GYNECARE VERSAPOINT Electrosurgical system is designed for hysteroscopic surgical procedures. A typical GYNECARE VERSAPOINT system (Figure 1.1) would comprise the following items: • GYNECARE VERSAPOINT electrosurgical generator • GYNECARE VERSAPOINT dual pedal footswitch

INTRODUCTION

• Re-usable 3m connector cable • A range of sterile, single use electrodes The electrodes, such as the 5Fr type shown in Figure 1.1, are approximately 360mm long and intended for insertion down the working channel of standard, commercially available hysteroscopes. Different active tip styles are available to provide apposite tissue effect according to preference and nature of the gynecological operation. Other electrode forms are available for use with custom Gynecare endoscopes. The electrodes are designed to provide both ablation and coagulation of tissue, only when activated within a saline environment, by pressing the yellow and blue pedals, respectively, of the footswitch. These terms are more correctly referred to as vaporization or “VaporCut” (VC), and “Desiccate” (DES) when applied to the GYNECARE VERSAPOINT system.

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2

1

3 13 11 12

9

10

4

6

5

7

8

INTRODUCTION 1-3

FIGURE 1.1 GYNECARE VERSAPOINT HYSTEROSCOPIC SYSTEM COMPONENTS 1. 2. 3.

GYNECARE VERSAPOINT Generator AC Power Input Footswitch Cable (Approx. 3m long) 4. Footswitch 5. Blue Pedal 6. Yellow Pedal 7. Connector Cable (Approx. 3m long) 8. 5Fr Electrode (Approx. 360mm long) 9. Character User Display 10. User Buttons 11. Fault Indicator 12. Connector Cable Socket 13. On/Off Switch Since the electrodes can only operate within a saline medium, the working tip geometry determines the amount of output power needed from the GYNECARE VERSAPOINT generator to reach the vaporization threshold. To simplify set-up and ensure that a power level commensurate with the electrode type is employed, the GYNECARE VERSAPOINT generator will automatically detect which electrode is in use and configure itself for recommended initial output power levels as defaults and also limit the maximum power available. Power level adjustment for both vaporization and desiccation modalities is performed by the front panel buttons with the selected levels shown on the user display.

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A sterile electrode is supplied and is discarded after use. It plugs into one end of the GYNECARE VERSAPOINT connector cable which will already have been attached to the GYNECARE VERSAPOINT generator via the front panel socket. The reusable Connector Cable is designed for steam sterilization and may be resterilized and used a maximum of 20 times. Activation by means of the footswitch, which is attached via the back panel, is prohibited until both the electrode and connector cable have been properly coupled to the GYNECARE VERSAPOINT generator. An audible alarm will sound whenever electrosurgical energy is being output. Diagnostic circuits within the GYNECARE VERSAPOINT generator continuously monitor system performance such that any detected faults are indicated as symbols on the user display in conjunction with illumination of the front panel warning symbol.

INDICATIONS FOR USE The GYNECARE VERSAPOINT Hysteroscopic System is an electrosurgical system used in conjunction with continuous flow hysteroscopes for correction of the following pathologies: • Myomas • Polyps • Intrauterine adhesions • Uterine Septa

CONTRAINDICATIONS FOR USE The GYNECARE VERSAPOINT electrosurgical system is NOT intended for use in tubal sterilization procedures. The use of this device is contraindicated in patients with the following conditions: • Acute cervicitis • Pregnancy • Cervical or uterine malignancy • Active pelvic inflammatory disease • Unaddressed adnexal pathology Use with extreme caution and very close fluid monitoring in the face of severe cardiopulmonary disease.

Patients with Pacemakers Use electrosurgical generators with caution in the presence of internal or external pacemakers. Interference from the electrosurgical current can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. For further information, consult the pacemaker manufacturer or hospital Cardiology Department.

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Section 2

PATIENT AND OPERATING ROOM SAFETY For the purposes of safety procedures and despite the absence of a conventional return pad, the GYNECARE VERSAPOINT system should still be treated as a high power electrosurgical device. The safe and effective use of electrosurgery depends to a large degree upon factors and variables solely under the control of the operator. There is no substitute for good surgical technique and properly trained operating room staff. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, and understood, and followed. Electrosurgery has been employed safely in numerous procedures. Before starting any surgical procedure the physician should be familiar with the medical literature, complications and hazards of hysteroscopic electrosurgery in that procedure.

PATIENT AND OPERATING ROOM SAFETY 2-1

GENERAL WARNING

Hazardous Electrical Output: This equipment is for use only by qualified personnel. CAUTION

Use the lowest appropriate power setting to achieve the desired effect. CAUTION

This equipment is capable of producing a physiological effect. CAUTION

Read the instructions, cautions, and warnings provided with GYNECARE VERSAPOINT accessories before use. This device is an integral system; only use GYNECARE VERSAPOINT approved accessories with the GYNECARE VERSAPOINT generator. CAUTION

If possible, avoid the use of needle style electrodes for any physiological monitoring equipment that may be connected to the patient during electrosurgery. CAUTION

Where practical, only use monitoring equipment that incorporates high frequency current limiting devices during electrosurgical procedures. CAUTION

The accessory cable should be positioned so that it avoids contact with the patient and any other leads.

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CAUTION

Studies have shown that electrosurgical smoke generated during electrosurgical procedures can be potentially harmful to surgical personnel. These studies recommend using surgical masks or other means of protection.1,2,3 CAUTION

Failure of the HF surgical equipment could result in an unintended increase of output power. WARNING

When endoscopes are used with energized endoscopically used accessories, the patient leakage may be additive. Ensure Proper Connections CAUTION

Examine all accessories and connections to the electrosurgical generator before use. Ensure that the accessories function as intended. Improper connection may result in arcs and sparks, accessory malfunction, or unintended surgical effects. Only For Use In Surgical Procedures With Normal Saline CAUTION

Tissue effects are achieved by a halo of electrical current surrounding the Electrode tip. Physical contact between the Electrode and tissue should be minimal, since damage to the Electrode tip may result. Similarly, the tip should always be kept in contact with the conductive irrigant solution to ensure proper performance and avoid excessive heating of the Electrode. CAUTION

Unless specified in the instructions for use accompanying an approved GYNECARE VERSAPOINT accessory, the GYNECARE VERSAPOINT system should only be activated with the working tip of the electrode accessory completely immersed in 0.9%w/v; 150mmol/l sodium chloride solution. For convenience, this will be referred to within the remainder of this manual as normal saline. CAUTION

As with the use of other hysteroscopic accessories, consideration as to whether or not to monitor the procedure laparoscopically should be based upon the specific procedure, individual patient characteristics, and physician preference. For additional guidance on the use of Laparoscopic monitoring for specific procedures, physicians are advised to reference A.C.O.G. recommendations. WARNING

Only use normal saline for irrigation during hysteroscopic procedures. Performance will be suppressed by use of other irrigating solutions such as Glycine, Sorbitol, Dextrose, Mannitol or other solutions containing non-physiological concentrations of electrolyte. WARNING

Fluid monitoring is required even when normal saline is used as a hysteroscopic distension medium.

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Servicing CAUTION

Electrical Shock Hazard: Do not tamper with the generator housing or attempt to remove the control panel. Refer to authorized personnel for service. NOTE

For maintenance of the electrosurgical generator unit refer to the recommended periodic equipment safety checks at Section 12. Servicing/Equipment Disposal CAUTION

The GYNECARE VERSAPOINT system Generator contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institution related policy relating to obsolete electronic equipment. CAUTION

Dispose of any system accessories according to normal institution practice relating to potentially contaminated items. FIRE/EXPLOSION

PATIENT AND OPERATING ROOM SAFETY

DANGER

2-3

Explosion Hazard: Do not use in the presence of flammable anesthetics. WARNING

Explosion Hazard: The following substances will contribute to increased fire and explosion hazards in the operating room: •

Flammable substances (such as alcohol based skin prepping agents and tinctures)

•

Naturally occurring flammable gases which may accumulate in body cavities such as the bowel

•

Oxygen enriched atmospheres

•

Oxidizing agents such as nitrous oxide (N2O) atmospheres

The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed.

Fire Hazard with Oxygen Circuit Connections WARNING

Fire/Explosion Hazard: Verify that all oxygen circuit connections are leak free before and during use of electrosurgery. Verify that endotracheal tubes are leak free and that the cuff is properly sealed to prevent oxygen leaks. BEFORE SURGERY Active Accessories WARNING

Electric Shock Hazard: Do not connect wet accessories to the generator.

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CAUTION

Read the instructions, warnings and cautions provided with the active accessories before using. WARNING

Accessories labeled “SINGLE USE” are single use only. Do not reuse or resterilize. CAUTION

Accessories labeled reusable must only be processed according to the recommended procedure and recycled the specific number of uses. CAUTION

Use default power levels to test an accessory. CAUTION

Use only GYNECARE VERSAPOINT approved accessories supplied for use with this product. Otherwise, product damage or accessory failure may result during use. CAUTION

Always inspect the system accessories for damage prior to use. In particular, check the cables of any reusable accessory for possible insulation damage. WARNING

Do not wrap accessory cords around metal objects. Wrapping cords around metal objects may induce currents that could lead to shocks, fires, or injury to the patient or surgical personnel. EMC PRECAUTIONS Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information in the accompanying documents. WARNING

Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING

The use of accessories and cables other than those for which the GYNECARE VERSAPOINT system was designed can significantly degrade emissions and immunity performance. WARNING

Keep the GYNECARE VERSAPOINT accessory cables away from cables from other electrical equipment. Electrical currents may be induced in the other equipment causing unintended effects. CAUTION

Provide as much separation as possible between the GYNECARE VERSAPOINT generator and other electronic equipment (such as monitors). When activating the GYNECARE VERSAPOINT generator, unintended electromagnetic coupling may cause interference with the other equipment. Should any unintentional effects appear upon other equipment when using the system, repositioning the GYNECARE VERSAPOINT generator, the connecting leads or other equipment may alleviate the problem. It may also help to use different mains supply sockets for any affected equipment. WARNING

Do not use monopolar generator/accessories simultaneously with the GYNECARE VERSAPOINT generator. Activation of a monopolar generator/accessories may cause interference with the GYNECARE VERSAPOINT generator resulting in user message changes on display. Before proceeding with surgery, confirm proper power settings are displayed on the generator. Ensure the appropriate output setting is enabled for the desired surgical outcome.

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Generator CAUTION

Nonfunction of the generator may cause interruption of surgery; ensure installation procedures are followed and that all connectors are correctly inserted before use. DURING SURGERY Contact With Metal Objects WARNING

Use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects. The working channel and operating sheaths of most hysteroscopes are metal. Do not activate the electrode while any portion of the electrode tip is within the working channel or in contact with another metal object; localized heating of the electrode and the adjacent metal object or working channel may result in damage to the hysteroscope, and/or electrode tip. WARNING

While using electrosurgery during a surgical procedure, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical table frame, instrument table, etc.). If this is not possible during certain procedures (e.g., those in which noninsulated head frames are used), use extreme caution to maximize patient safety.

PATIENT AND OPERATING ROOM SAFETY

Generator Power Settings

2-5

WARNING

Confirm proper electrosurgical generator power settings before proceeding with surgery. Use the lowest appropriate power setting to achieve the desired effect. Always check that the automatic default settings shown on the display match those indicated on the active electrode packaging. CAUTION

Use caution when overriding the default power settings. CAUTION

Should a power supply interruption occur, the generator power settings will revert to the minimum values when power is re-established should the accessory combination still be connected. Active Accessories WARNING

Do not imbed the Electrode tip in tissue as excessive heating and damage to the tip may result. WARNING

Do not use the Electrode tip to probe or manipulate tissues. Mechanical contact between Electrode tips and tissues or other instruments may result in damage to the instrument. WARNING

Bubbles are produced during tissue vaporization which may interrupt surgery by temporarily interfering with vision and may also result in over heating and cause damage to the Electrode tip; a continuous flow hysteroscope system is recommended to prevent accumulation and remove bubbles from the operative field. WARNING

When not in use place active electrodes in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent activation while in contact with the patient may result in burns.

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WARNING

Fire Hazard: Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories which are activated or hot from use can cause a fire. Laparoscopy, Endoscopy and Related Procedures WARNING

As visualization may be impaired during hysteroscopy for a number of reasons, be particularly alert to these potential hazards: •

The accessory tip may remain hot enough to cause burns after the electrosurgical current is deactivated.

•

Inadvertent activation or movement of the activated electrodes outside the field of vision may result in injury to the patient.

•

Localized burns to the patient or physician may result from electrical currents carried through conductive objects. Electrical current may be generated in conductive objects by direct contact with the active electrode, or by the active or return electrode being in close proximity to the conductive object.

•

Carefully insert and withdraw active electrodes from working channels to avoid the possibility of damage to the devices and/or injury to the patient.

•

Only operate the device in the endometrial cavity with continuous flow irrigation to ensure good visualization as well as cooling the accessory tip between activations.

•

Only use normal saline irrigation solution. The performance of the system will be adversely affected by use of any other solution.

•

Do not activate when not in contact with tissue, or excessive heating of the irrigation medium may result.

•

Tissue drilling is a common surgical technique and while the GYNECARE VERSAPOINT electrodes may be used for this purpose, do not insert the electrode beyond the junction of the return electrode and insulator as this may result in overheating and electrode failure. Care should also be taken to avoid perforation of the uterus when employing this technique.

CAUTION

Normal use of the system restrains tissue contact to only the active tip of the electrode. No user or patient hazard will arise should the electrical return electrode portion of the electrode make simultaneous tissue contact other than where explicit warnings are given. ADVERSE EFFECTS Contact of heated Electrode tip with tissues not intended for electrosurgical treatment may result in tissue injury. If excessive heating or physical forces cause damage to the Electrode tip, foreign body fragments may result, requiring extended surgery for removal.

1 William S. Sawchuck, et al., “Infectious Papilloma Virus in the Vapor of Warts Treated with Laser or Electrocoagulation: Detection and Protection,” Journal of the American Academy of Dermatology, Vol21, No.1 (July, 1989:41–49). 2 Yoshifumi Tomita, et al., “Mutagenicity of Smoke Condensates Induced by CO 2 Laser Irradiation and Electrocauterization,” Mutation Research, Vol 89 (1981): 145–149. 3 U.S. Department of Health and Human Services. Public Health Service. Health Hazard Evaluation Report No. 85-126 (National Technical Information Service, 1985).

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Section 3

INSTALLATION The electrosurgical generator described in this manual, in conjunction with the available accessories, is designed to be used as a system to provide advanced electrosurgical effects during hysteroscopic surgery including the debulking of intracavitary tissue by vaporization under normal saline irrigation.

RESPONSIBILITY OF THE MANUFACTURER The manufacturer is responsible for safety, reliability, and performance of the equipment only if: • Installation procedures in this manual are followed. • Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by the manufacturer and the electrical installation of the relevant operating room complies with local codes and regulatory requirements. • The equipment is used in accordance with these instructions for use.

GENERATOR POWER REQUIREMENTS The generator is designed to operate at 90-132VAC, 198-264VAC at 50/60Hz. This allows the generator output to remain constant in case of power fluctuations.

Check the Generator Power Connection Your generator supplier will provide a hospital grade power plug. The power connector meets all requirements for safe grounding. Its purpose should not be defeated by using extension cords or three-prong to two-prong adapters. Cords should always be grasped by the plug. Do not pull on the cord itself.

GROUNDING OF THE GENERATOR To ensure user safety the generator must be properly grounded through the inlet plug and power cord. IMPORTANT

Ensure that the electrical installation of the relevant room complies with local codes and regulatory requirements. EMC CONSIDERATIONS The GYNECARE VERSAPOINT generator should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, both the GYNECARE VERSAPOINT generator and other equipment should be observed to verify normal operation in the configuration in which it will be used. The EMC classification of the GYNECARE VERSAPOINT system (class A) is suitable for use on dedicated supply systems not connected to the public mains network, such as hospitals.

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NOTE: Although class A limits have been derived for industrial and commercial establishments, administrations may allow, with whatever additional measures necessary, the installation and use of class A ISM equipment in a domestic establishment or establishment connected directly to domestic electricity power supplies. Guidance and Manufacturer's Declaration - Electromagnetic Emissions The GYNECARE VERSAPOINT Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the GYNECARE VERSAPOINT Generator should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1 The GYNECARE VERSAPOINT Generator CISPR 11 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions Class A The GYNECARE VERSAPOINT Generator CISPR 11 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic Emissions Class A IEC 61000-3-2 Voltage Fluctuations / Flicker Complies Emissions IEC 61000-3-3

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The GYNECARE VERSAPOINT Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the GYNECARE VERSAPOINT Generator should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV Contact

±6 kV Contact

±8 kV Air

±8 kV Air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient / Burst IEC 61000-4-4

±2 kV for Power Supply Lines

±2 kV for Power Supply Lines

±1 kV for Input / Output Lines

±1 kV for Input / Output Lines

±1 kV Differential Mode

±1 kV Differential Mode

Surge IEC 61000-4-5

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.

±2 kV Common Mode ±2 kV Common Mode Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000-4-11

Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8

<5 % UT (>95 % Dip in UT) for 0.5 Cycle

70 % UT (30 % Dip in UT) for 25 Cycle

<5 % UT Mains power quality should be that of a (>95 % Dip in UT) for 0, typical commercial or hospital environment. If the user of the 5 Cycle GYNECARE VERSAPOINT Generator requires continued operation during 40 % UT power mains interruptions, it is (60 % Dip in UT) for recommended that the GYNECARE 5 Cycle VERSAPOINT Generator be powered from an uninterruptible power supply or a 70 % UT battery. (30 % Dip in UT) for 25 Cycle

<5 % UT (>95 % Dip in UT) for 5 sec

<5 % UT (>95 % Dip in UT) for 5 sec

3 A/m

3 A/m

40 % UT (60 % Dip in UT) for 5 Cycle

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

NOTE: UT is the a.c. mains voltage prior to application of the test level.

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity The GYNECARE VERSAPOINT Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the GYNECARE VERSAPOINT Generator should assure that it is used in such an environment. IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

Radiated RF IEC 61000-4-3

3 Vrms 80 MHz to 2.5 GHz

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the GYNECARE VERSAPOINT Generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Immunity Test

Recommended Separation Distance

d = [1.17] d = [1.17]

80 MHz to 800 MHz

d = [2.33]

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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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. 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 elctromagnetic site survey should be considered. If the measured field strength in the location in which the GYNECARE VERSAPOINT Generator is used exceeds the applicable RF compliance level above, the GYNECARE VERSAPOINT Generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the GYNECARE VERSAPOINT Generator.

a

b

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

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Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the GYNECARE VERSAPOINT Generator The GYNECARE VERSAPOINT Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the GYNECARE VERSAPOINT Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the GYNECARE VERSAPOINT Generator as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter

Separation Distance According to Frequency of Transmitter m

W 150 kHz to 80 MHz

d = [3.5/V1]

80 MHz to 800 MHz

d = [3.5/E1]

800 MHz to 2.5 GHz

d = [7/E1]

0.01

0.12

0.12

0.1

0.37

0.37

0.23 0.74

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

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 power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for 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.

Routine Maintenance of the Generator It is recommended that the generator be inspected by qualified service personnel in accordance with Section 12, Periodic Equipment Safety Checks.

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Section 4

GENERAL INFORMATION GENERATOR INDICATORS AND DISPLAYS On-Press this button to switch on the generator. When the generator is on, the green light within the on button is illuminated. When the generator is off, it is not available for use. Off-Press this button to switch off the generator. It is in the user’s interests to switch off the generator whenever it is not in use to avoid any possibility of inadvertent activation.

GENERATOR OUTPUT MODE, POWER CONTROLS AND DISPLAY Power Up/Down-These buttons adjust the default power setting determined by electrode configuration; the yellow arrow buttons for the VaporCut and Blend outputs and the blue arrow keys for the Desiccate output. Power setting may be set from minimum to maximum using the up arrow buttons, and set from maximum to minimum using the down arrow buttons. Press the appropriate button once for a power increment or decrement. Holding down the button accelerates the incrementation or decrementation. NOTE

Power can only be adjusted with the generator in the Ready mode once an electrode is properly connected to the generator. The active electrode will determine its own default output power and power set range limits as indicated on the electrode packaging. Power Setting Displays-The display is divided into two sections indicated by the underlying yellow and blue bars. Above the yellow bar (left-hand side of the display) the nominal output power in Watts is displayed for the selected output mode. Above the blue bar (right-hand side of the display), the nominal output power in Watts is displayed for the desiccate output. When an output is activated, the power display for the selected output flashes and an audible tone sounds. Mode Selection-There are three VaporCut modalities shown as VC1, VC2 and VC3 on the left hand side of the power setting display. These produce a tissue effect decreasing from VC1 to VC3. Two blended outputs are also available, shown as ‘BL1’ and ‘BL2,’ on the left hand side (YEL) which continuously switch between a VaporCut and Desiccate output during activation. In both cases, the output will alternate many times a second. The principal difference between the two blend modes is the repetition rates employed. A blended output will provide a degree of hemostasis during tissue vaporization. Depressing the mode button once will enable selection of these options using the power up button of the Desiccate (BLUE) output. Once the display shows the desired yellow (YEL) output mode then holding the mode button down for approximately one second will return the generator to the Ready condition upon release of the mode button.

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GENERAL INFORMATION 4-1

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O U T P U T

( Y E L )

Indicates that the output waveform modality for yellow pedal activation can be selected.

NOTE

Output modality selection can only be performed with an electrode and connector cable attached to the generator. NOTE

VC1 mode selection is inhibited by connection of certain electrode configurations to the generator. NOTE

If the mode key is quickly pressed and released the next user set-up option appears. GENERATOR INDICATORS SET-UP AND MALFUNCTION DISPLAYS Electrode prompt Power up-When the generator is first switched on prior to electrode connection, a user verification sequence will be initiated. Once this is satisfactorily completed the display will prompt the user to first connect the connector cable and then connect an electrode by flashing the symbols “CONNECT CABLE” and “INSERT ELECTRODE” respectively, on the display. This represents the idle mode of the generator. Until an electrode and connector cable are detected by the generator, all controls are inhibited. Once an electrode is properly connected, the generator enters the Ready mode which enables the controls.

C O N N E C T

I N S E R T

C A B L E

E L E C T R O D E

Indicates that the generator is waiting for a connector cable to be attached to the front panel receptacle. Indicates that the generator is waiting for an electrode to be inserted into the attached connector cable.

Set-up and Defaults Electrode output default settings-Each electrode configuration has an internal classification code which is interrogated by the generator. Depending on this code, optimal output mode and power settings are automatically set. These can be adjusted, but certain output modes may be inhibited and power adjustment limits imposed to ensure the safe operation of a particular electrode type. Activation Selection-From the Ready state, depress and release the mode button twice to enable activation selection. If your generator version supports both a footswitch and handswitching accessories that may become available in the future, the activation source can be toggled between FOOTSWITCH and HANDSWITCH. Otherwise the menu will confirm that footswitch operation is enabled by showing FOOTSWITCH on the display. Holding down the mode button for one second and then releasing it will return to the Ready state.

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F O O T SW I T C H

Indicates that the footswitch is the activation source for the system.

Activation Status Activate-Using a footswitch, when the generator is activated, the power display of the selected output flashes and an audible tone sounds. If neither occurs, then there is a malfunction.

Activate Tone Volume Adjustment Activate tone volume-The activation tone volume can be adjusted between minimum and maximum using the up control of the desiccate (blue) power control once the mode selection button has been depressed and released three times. The tone can be verified by depressing the down button of the desiccate (blue) power control during selection. Press and release the mode button once more to return the generator to Ready mode.

A L A RM

V O L UM E

Indicates that the audio alarm output level may be selected. ‘MIN’ is the lowest volume available, ‘MAX’ is the loudest.

Error Code Display Non-critical failure-If a fault is detected during set-up or during use an error code message is displayed. Refer to Section 8, Operating Room Troubleshooting.

Critical Failure Red Warning light-Except during the self-test routine, when the red warning light on the front panel is illuminated this indicates a critical failure. DO NOT ATTEMPT TO USE THE UNIT. Refer immediately to an approved service agent or return to the manufacturer if the generator is still under warranty.

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GENERATOR CONNECTORS AND RECEPTACLES 1. FRONT VIEW 2. DISPLAY WINDOW 3. MEMBRANE PANEL 4. CONNECTOR CABLE SOCKET 5. MAINS ON/OFF SWITCH 6. BACK VIEW 7. HEATSINK 8. SERIAL NUMBER LABEL 9. EARTH STUD 10. MAINS POWER INPUT SOCKET 11. FOOTSWITCH SOCKET 1

FENETRE 2 D’AFFICHAGE

4 DU CABLE DOUILLE DE CONEXXION

5

NTERRUPTEUR RINCIPAL

GENERAL INFORMATION

PANNEAU3A MEMBRANE

4-4

GENERATOR FASCIA

FACE AVANT DU GENERATEUR

ERRIERE 6 RADIATEUR

7

ETIQUETTE PORTANT 8 LE NUMERO DE SERIE

DOUILLE DE CONNEXION DE LA PEDALE

BACK PANEL

9 CONNE DE TER

11 10 PRISE D’ALIME SECTEUR

PANNEAU ARRIERE

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