VERSAPOINT II User Manual June 2010

TABLE OF CONTENTS

SECTION 1 Introduction

PAGE

Overview of Endoscopic Surgery... 1-1 Comparison with Conventional Electrosurgery... 1-1 System Description... 1-1 Indications for Use... 1-4 Contraindications for Use... 1-4 Patients with Pacemakers... 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 References... 2-6

3

Installation Responsibility of the Manufacturer... 3-1 Generator Power Requirements... 3-1 Grounding of the Generator... 3-1 EMC Considerations... 3-1 Routine Maintenance of the Generator... 3-4

4

General Information Generator Indicators and Displays... 4-1 Generator Indicators Setup and Malfunction Displays ... 4-3 Wired Footswitch ... 4-4 Remote Adjustment of the Output Mode and Power ... 4-5

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

GYNECARE VERSAPOINT™ II USER MANUAL

Section 1

ENGLISH

Introduction This user’s manual will familiarize you with the controls and output functions available from your GYNECARE VERSAPOINT™ II Hysteroscopic Generator1 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 hysteroscopic surgery, liquid distension is usually the preferred method in hysteroscopic, urological, and arthroscopic endoscopy. GYNECARE VERSAPOINT™ combines the two conventional output modalities of bipolar and monopolar electrosurgery in specific system configurations for endoscopic surgery. The GYNECARE VERSAPOINT™ System provides a form of electrosurgery specifically developed for hysteroscopic endoscopic applications.

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™ II System utilizes the fact that the irrigating solution is conductive to stagger the electrode arrangement at the tip so that the “return” electrode is mounted on the shaft of the instrument and thus remote from tissue. 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 problems commonly encountered when using bipolar electrosurgery: orientation of the electrode to tissue, visualization of the working tip, tissue sticking, and limited power delivery.

SYSTEM DESCRIPTION The GYNECARE VERSAPOINT™ System is designed for hysteroscopic surgical procedures. The various components of the system are designed to be used together and operated as an integrated system (see Diagram 1). The GYNECARE VERSAPOINT™ and GYNECARE VERSAPOINT™ II product lines will be referred to within the remainder of this manual as the GYNECARE VERSAPOINT™ System. The following Electrodes and accessories are compatible with the GYNECARE VERSAPOINT™ II Generator (Gold Fascia): 1. GYNECARE VERSAPOINT™ 5 French Electrodes 2. GYNECARE VERSAPOINT™ 2.5 mm & 0° Electrodes 3. GYNECARE VERSAPOINT™ II 4.0 mm Electrode1 4. GYNECARE VERSAPOINT™ II Footswitch1 (Dual pedal with black mode-selection button) 5. GYNECARE VERSAPOINT™ II Connector Cable1 (Black plug) 6. GYNECARE VERSAPOINT™ Connector Cable (Gray plug) 7. GYNECARE VERSAPOINT™ Resectoscopic System Resectoscope 1Availability subject to local regulatory requirements.

GYNECARE VERSAPOINT™ II USER MANUAL

Introduction 1-1

 GYNECARE VERSAPOINT™ II





GYNECARE VERSAPOINT™ II FOOTSWITCH



GYNECARE VERSAPOINT™ II GENERATOR

GYNECARE VERSAPOINT™ CONNECTOR CABLE



GYNECARE VERSAPOINT™ II CONNECTOR CABLE

Introduction 4.0 mm Electrode

0° Electrode

0° Electrode

2.5 mm Electrode

2.5 mm Electrode

5 French Ball, Spring, Twizzle Electrodes

5 French Ball, Spring, Twizzle Electrodes

DIAGRAM 1

Different active Electrode tip styles are available to provide opposite tissue effect according to preference and nature of the gynecological operation. 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), “Versa Pulse” (VP), and “Desiccate” (DES) when applied to the GYNECARE VERSAPOINT™ II Generator.

GYNECARE VERSAPOINT™ II USER MANUAL

1-2

12

2

1

11

4 3

10

8

9

9

7

6

5

FRONT PANEL–GENERATOR

13

17

14 15

16

Introduction BACK PANEL–GENERATOR

1-3

18 21

22

23

20

FOOTSWITCH

19

ELECTRODE WITH CONNECTOR CABLE

Figure 1-1 GYNECARE VERSAPOINT™ II Generator System Components 1. 2. 3. 4. 5. 6.

Visual Display Fault Indicator Connector Cable Socket Footswitch Socket Wired Footswitch Selection Button Wireless Footswitch Selection Button (currently disabled) 7. Handswitch Selection Button (currently disabled) 8. Generator Mode-Selection Button 9. Power Control Buttons 10. On/Off Indicator 11. Volume Adjustment Buttons

12. On/Off Switch 13. USB Socket (service use only) 14. AC Power Input Socket 15. Earth Stud 16. Serial Number Label 17. Serial Port (service use only) 18. Footswitch Cable 19. Footswitch Blue Pedal 20. Footswitch Yellow Pedal 21. Footswitch Mode-Selection Button 22. Connector Cable (approximately 3 m long) 23. Electrode

GYNECARE VERSAPOINT™ II USER MANUAL

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™ II Generator to reach the vaporization threshold. To simplify setup and ensure that a power level commensurate with the Electrode type is employed, the GYNECARE VERSAPOINT™ II 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 or remotely by means of the Footswitch, with the selected levels shown on the user display. A sterile Electrode is supplied and is discarded after use. It plugs into one end of the Connector Cable, which will already have been attached to the 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 to the front-mounted Footswitch socket, is prohibited until both the Electrode and Connector Cable have been properly coupled to the Generator. An audible alarm will sound whenever electrosurgical energy is being output. Diagnostic circuits within the 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

Introduction 1-4

• 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 • Acute 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.

GYNECARE VERSAPOINT™ II USER MANUAL

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, 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™ System accessories before use. This device is an integral system; only use approved GYNECARE VERSAPOINT™ System accessories with the GYNECARE VERSAPOINT™ II 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. 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

GYNECARE VERSAPOINT™ II USER MANUAL

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™ System accessory, the GYNECARE VERSAPOINT™ System should only be activated with the working tip of the Electrode accessory completely immersed in 0.9% w/v; 150 mmol/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 ACOG 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. 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” in Section 12.

GYNECARE VERSAPOINT™ II USER MANUAL

Patient and Operating Room Safety 2-2

Servicing/Equipment Disposal CAUTION

The 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. Please visit http://www.ethicon.com/recycling for more information. CAUTION

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

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. 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.

GYNECARE VERSAPOINT™ II USER MANUAL

Patient and Operating Room Safety 2-3

CAUTION

Use default power levels to test an accessory. CAUTION

Use only approved GYNECARE VERSAPOINT™ System 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™ System accessory cables away from cables of other electrical equipment. Electrical currents may be induced in the other equipment, causing unintended effects. CAUTION

Provide as much separation as possible between the Generator and other electronic equipment (such as monitors). When activating the 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 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 Generator. Activation of monopolar generator/accessories may cause interference with the 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. Generator CAUTION

Non-function of the Generator may cause interruption of surgery; ensure installation procedures are followed and that all connectors are correctly inserted before use.

GYNECARE VERSAPOINT™ II USER MANUAL

Patient and Operating Room Safety 2-4

DURING SURGERY Contact with Metal Objects WARNING

Use extreme caution when using electrosurgery in 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 non-insulated head frames are used), use extreme caution to maximize patient safety. Generator Power Settings 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 reestablished, 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 tissue. Mechanical contact between Electrode tips and tissue 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 overheating 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, non-conductive, and highly visible area not in contact with the patient. Inadvertent activation while in contact with the patient may result in burns. 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.

GYNECARE VERSAPOINT™ II USER MANUAL

Patient and Operating Room Safety 2-5

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 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 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 tissue 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.

REFERENCES 1 Sawchuck WS, et al. Infectious papilloma virus in the vapor of warts treated with laser or electrocoagulation: detection

and protection. J Am Acad Dermatol. 1989;21:41-49. 2 Tomita Y, et al. Mutagenicity of smoke condensates induced by CO -laser irradiation and electrocauterization. Mutat 2

Res. 1981;89:145-149.

3 U.S. Department of Health and Human Services. Public Health Service. Health Hazard Evaluation Report No. 85-126

(National Technical Information Service, 1985).

GYNECARE VERSAPOINT™ II USER MANUAL

Patient and Operating Room Safety 2-6

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 the safety, reliability, and performance of the equipment only if: • Installation procedures in this manual are followed. • Assembly operations, extensions, readjustments, 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 50/60 Hz. 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 Generator should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, the Generator and other equipment should be observed to verify normal operation in the configuration in which they 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. 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.

GYNECARE VERSAPOINT™ II USER MANUAL

Installation 3-1

Guidance and Manufacturer’s Declaration–Electromagnetic Emissions The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator should ensure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment–Guidance

RF Emissions

Group 1

The Generator 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.

Class A

The Generator 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.

CISPR 11

RF Emissions CISPR 11 Harmonic Emissions

Class A

IEC 61000-3-2 Voltage Fluctuations / Flicker Emissions

Complies

IEC 61000-3-3

Guidance and Manufacturer’s Declaration–Electromagnetic Immunity The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator should ensure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment–Guidance

±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

±2 kV for Power Supply Lines

±2 kV for Power Supply Lines

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

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

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

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

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

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

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

70% UT (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

Electrostatic Discharge (ESD) IEC 61000-4-2

IEC 61000-4-5

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

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 Generator requires continued operation during power mains interruptions, it is recommended that the Generator 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.

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

GYNECARE VERSAPOINT™ II USER MANUAL

Installation 3-2

Guidance and Manufacturer’s Declaration–Electromagnetic Immunity (continued) The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator should ensure that it is used in such an environment. Immunity Test

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 Generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 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 meters (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:

Installation 3-3

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 Generator is used exceeds the applicable RF compliance level above, the Generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Generator. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

GYNECARE VERSAPOINT™ II USER MANUAL

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

Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = [3.5/V1]

d = [3.5/E1]

d = [7/E1]

0.01

0.12

0.12

0.23

0.1

0.37

0.37

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.”

GYNECARE VERSAPOINT™ II USER MANUAL

Installation 3-4

Section 4

General Information GENERATOR INDICATORS AND DISPLAYS (REFER TO FIGURE 1-1) On/Off Switch 12 The power switch turns AC power on and off. It is advisable to switch off the Generator whenever it is not in use to avoid any possibility of inadvertent activation. When the Generator is on, the green light power indicator 10 is illuminated.

General Information Fault Indicator 2 This light will illuminate red to indicate a Generator critical failure or an accessory malfunction. NOTE

The light will illuminate briefly during the self-test routine. This is normal and does not indicate a failure.

Generator Mode-Selection Button 8 There are three VaporCut modalities, shown as VC1, VC2, and VC3, on the left-hand side (yellow) of the power setting display. These produce a tissue effect decreasing from VC1 to VC3. A pulsed (VP) mode is also available for use with the 4.0 mm Angled Loop Electrode to deliver a high-energy “boost” output to facilitate electrode fire-up. Two blended outputs are available, shown as “BL1” and “BL2,” on the left-hand side (yellow) 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 and upper voltage limit employed. These blend modes provide a degree of haemostasis during tissue ablation. A blended variant of the VP mode is also available, shown as “VBL,” for use with the 4.0 mm Angled Loop Electrode. This VBL mode also provides a degree of haemostasis during tissue ablation. Depressing the MODE button once will enable selection of these options using the yellow UP/DOWN buttons. Once the display shows the desired 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.

GYNECARE VERSAPOINT™ II USER MANUAL

4-1

Power Control Buttons 9 The UP and DOWN buttons adjust the default power setting; the yellow ARROW button controls the Vaporization (VC), Pulsed Vaporization (VP), and Blended Vaporization (VBL) outputs. The blue ARROW buttons control the Desiccate (DES) output. Press the appropriate button once for a power increment or decrement. Holding down the button accelerates the change in the power setting. These keys are also used as “soft keys” when the system requires operator interaction (e.g., when last used settings are selected). 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.

On/Off Indicator 10 Illuminates green when the unit is switched on.

Volume Adjustment Buttons 11 Enable the output tone to be adjusted between minimum and maximum levels.

General Information 4-2

Wired Footswitch Selection Button 5 Press to select. Illuminates when the unit is in wired footswitch mode.

Wireless Footswitch Selection Button

Handswitch Selection Button

7

6

(currently disabled)

(currently disabled)

Visual Display 1 The left side displays the nominal output power in watts for the selected Vaporization (VC), Pulsed Vaporization (VP), or Blended Vaporization (BL and VBL) modes. The right side displays the nominal output power in watts for the Desiccate (DES) output. When an output is activated, the power display for the selected output flashes and an audible tone sounds. NOTE •O  utput modality selection can only be performed with an Electrode and Connector Cable

attached to the Generator. • V C1 mode selection is inhibited by connection of certain Electrode configurations to

the Generator. • P ressing the MODE button allows the user to loop through the output modes (e.g., VC1 to VC2 to

VC3 to BL1 to BL2; or VP to VBL).

GYNECARE VERSAPOINT™ II USER MANUAL

GENERATOR INDICATORS SETUP 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 (Figure 4-1) and then insert an Electrode (Figure 4-2) 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 inserted, the Generator enters the ready mode, which enables the controls. C

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Indicates that the Generator is waiting for a Connector Cable to be attached to the front panel receptacle.

FIGURE 4-1 I

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Indicates that the Generator is waiting for an Electrode to be inserted into the attached Connector Cable.

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FIGURE 4-2

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Setup and Defaults Electrode output default settings-Each Electrode configuration has an internal classification code which is recognized by the Generator. Depending on this code, optimal output mode and power settings are automatically set if last used settings are not detected (refer to “Last Used Setting” section). 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 Status Activate-Use the Footswitch to activate the Generator from the ready state. The visual display of the selected output flashes and an audible tone sounds. If neither occurs, then there is a malfunction. The display will indicate the Electrode type, output mode, and default power settings (Figure 4-3). E

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FIGURE 4-3

Volume Adjustment Activation Volume adjustment-The tone volume can be changed between minimum and maximum settings using the UP and DOWN volume adjustment buttons located on the left side of the main display. V M

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General Information

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The bar graph indicates the range and current volume setting. “Min” is the lowest volume available; “Max” is the loudest.

FIGURE 4-4

GYNECARE VERSAPOINT™ II USER MANUAL

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

Critical Failure Fault indicator-The red light is illuminated to indicate a critical failure, except during the self-test routine. 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.

Last Used Setting Each individual Electrode is identified by the Generator, initiated for optimal performance, and default settings displayed. These settings may be adjusted, if required, within predefined safe and useful limits for the particular Electrode attached. If the operator chooses to change the output mode or power so that the displayed setting is not the default, the system will retain the selected parameters and allow the operator to utilize these settings when the Generator is next used. The last used feature is available on all Electrodes. If a stored setting is detected by the Generator, then the display will indicate the previously used settings and prompt the user to accept this last used setting by pressing the yellow UP key or use the default setting by pressing the blue UP key.

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NOTE

The operator will be prompted to accept or reject last used settings only if the default parameters have been adjusted. U

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General Information

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FIGURE 4-5

WIRED FOOTSWITCH The GYNECARE VERSAPOINT™ II Wired Footswitch connects to the GYNECARE VERSAPOINT™ II Generator. The yellow and blue pedals are used for output activation. The MODE button is used for fault clearance or remote adjustment of the output settings. The adjacent light will illuminate when the Generator is in the ready state.

• Depressing the yellow pedal activates the selected Ablation (VC), Pulsed Ablation (VP), or Blended Ablation (BL or VBL) outputs. • Depressing the blue pedal activates the Desiccate (DES) output to produce haemostasis (coagulation). • D epressing the MODE button can reset the Generator from a fault condition.

GYNECARE VERSAPOINT™ II USER MANUAL