Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) User Manual Feb 2011

………OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI SuprePulse Generator and instruct you on its proper use.

Gyrus Medical, Ltd. 2010. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into any language or computer language, in any form, or by any means: electronic, mechanical, magnetic, optical, or otherwise, without the prior written permission of Gyrus ACMI.

Patents

This product may be covered by one or more of the following US patents: 5,944,715; 6,004,319; 6,013,076; 6,015,406; 6,045,549; 6,056,746; 6,074,386, 6,090,106, 6,093,186; 6,152,143; 6,131,579; 6,179,803; 6,210,355; 6,210,405; 6,228,081; 6,234,178; 6,261,286; 6,293,942; 6,303,134; 6,364,877; 6,416,491; 6,416,509; 6,482,202; 6,517,535; 6,371,926; 6,682,501, 6,893,435,6,984,231, 7,214,224, 7,211,081, 7,195,627. Associated Patents are in place in other countries

OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR The Gyrus ACMI SuperPulse Generator forms a versatile platform for Urology and General surgical use. Ensure that the contents of this User Manual are read and understood before proceeding to use the Gyrus ACMI SuperPulse Generator.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) Part Number: 144020-LB

USER MANUAL

Overview

OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR

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……………………………….TABLE OF CONTENTS

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SECTION

PART

1

INTRODUCTION Overview of the Superpulse System 1-1 Comparison with Conventional Surgery 1-1 Indications for Use 1-2 Contraindications for Use 1-2 System Description 1-2 PATIENT AND OPERATING ROOM SAFETY General 2-1 Servicing/Equipment Disposal 2-2 Fire/Explosion 2-3 Before Surgery 2-3 During Surgery 2-4 After Surgery 2-6 EMC Classification 2-6 INSTALLATION Responsibility of the Manufacturer 3-1 SuperPulse Generator Power Requirements 3-1 Grounding of the SuperPulse Generator 3-1 Routine Maintenance of the SuperPulse Generator 3-1 GENERAL INFORMATION SuperPulse Generator Indicators and Displays 4-1 Output Mode Selection Power Controls 4-3 Olympus TURis Mode 4-5 SuperPulse Generator Indicators, Set-up and Malfunction Displays 4-7 Changing the Display Language 4-10 Enabling Additional Instruments via a PIN code 4-11 BEFORE SURGERY Power up the SuperPulse Generator 5-1 Select the Appropriate PK/SP Instrument(s) for the Procedure 5-2 Steam Sterilise the PK Connector Cable, PlasmaKinetic Resectoscope or appropriate urological endoscope 5-4 Connect the PK Connector Cable 5-4 5-4 Prepare the PlasmaKinetic Resectoscope or urological endoscope Attach PlasmaKinetic Instrument to the PK Connector Cable 5-8 DURING SURGERY Accessories 6-1 Recommendations during Surgery 6-1 TECHNIQUES TO OPTIMIZE PERFORMANCE 7-1 AFTER SURGERY Following Surgery Involving PlasmaKinetic Resectoscope Instruments 8-1 Following Surgery Involving PlasmaKinetic Cystoscope Instruments 8-1 Following all Surgery Involving the Superpulse Endourology System 8-2 OPERATING ROOM TROUBLESHOOTING 9-1 PERFORMANCE SPECIFICATIONS 10-1 ERROR AND FAULT CODES 11-1 EXPLANATION OF SYMBOLS 12-1 PERIODIC EQUIPMENT SAFETY CHECKS 13-1 EMC TABLES 14-1 LIMITED WARRANTY 15-1

1A 1B 1C 1D 1E 2 2A 2B. 2C 2D 2E 2F 2G 3

TABLE OF CONTENTS

3A 3B 3C 3D. 4 4A 4B 4C 4D 4E 4F 5 5A 5B 5C 5D 5E 5F 6 6A 6B 7 8 8A 8B 8C 9 10 11 12 13 14 15

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) Part Number: 144020-LB

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INTRODUCTION

Gyrus Medical Ltd, Gyrus Medical Inc and Gyrus ACMI Inc are referred to as Gyrus ACMI in this user manual. This user’s manual will familiarise you with the controls and output functions available from your SuperPulse System and instruct you on its proper use. 1A.

Overview of the SuperPulse System

Electro surgery is a familiar tool widely employed in urological endoscopy to perform transurethral prostatectomy (TURP), resection of bladder tumours and cystodiathermy. Based on similar principles, the PlasmaKinetic technology exploits the electrical conductive properties of fluid used to distend the operative site, requiring the standard non-electrolyte irrigation fluids used during conventional TURP to be replaced by normal saline. By adjusting power in microseconds two tissue effect modes can be produced. In the first mode, an ionised plasma corona is created over the active zone of a tissue treatment electrode. Tissue entering the intense kinetic energy of the corona is instantly reduced to its constituent elements and simply washed away in the irrigation fluid. The low thermal mass of the plasma prevents collateral tissue damage adjacent to the application site. In the second mode, rapid, predictable and controlled elevations in tissue temperature can be produced to ablate tissue or seal blood vessels.

SECTION 1

An endoscope is an instrument routinely employed to visualise and access the interior of various body cavities for the purposes of both diagnostic and surgical procedures. 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 for the passage of surgical instruments, as well as conduits for the passage of gas or liquid required to distend the body cavity. Commonly referred to as ‘underwater surgery’, liquid distension is usually the preferred method in urological endoscopy.

The SuperPulse mode of operation enables very rapid formation of the plasma enabling easier and more rapid resection of tissue. 1B.

Comparison with Conventional Electrosurgery

The intense concentration of electrosurgical energy delivered by the technology offers instantaneous vaporisation of tissue. 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 recognised complications and safety concerns. Furthermore, the deep tissue heating of monopolar arrangements which occurs during tissue vaporisation causes a progressive deterioration in efficiency over the period of the procedure. The PlasmaKinetic technology overcomes this problem and provides a repeatable tissue effect throughout the procedure. In order for the system to produce this effect, the SuperPulse Generator has integral feedback systems to both initiate and sustain the plasma corona around the active electrode. The instruments can only operate within a saline medium. The size of the working tip geometry determines the amount of power needed to ensure optimal performance. To simplify set-up the

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INTRODUCTION

Conventional bipolar electrosurgery requires that 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 Gyrus ACMI SuperPulse Endourology System utilises the fact that saline is electrically conductive to control an ionised plasma around the active tip when electrosurgical current is applied. Essential to this design is the proximity of the return electrode to the active electrode in an AxipolarTM configuration. The fact that the two poles of the circuit are only a few millimetres apart means that current flows only through the irrigant or through the tissue to be vaporised. This localised current flow preserves the recognised safety features of conventional bipolar electrosurgery. Similarly, this arrangement avoids many of the problems commonly encountered when using bipolar electrosurgery: orientation of the electrode to tissue, visualisation of the working tip, tissue sticking and limited power delivery.

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INTRODUCTION

SECTION 1

SuperPulse Generator will automatically select a default power and mode setting according to the instrument type. Power and mode adjustments can be performed by the front panel buttons with the selected output shown on the user display. Instruments are supplied in a sterile, single use format and connect to the SuperPulse Generator via a limited re-use connector cable. Activation of the electrosurgical current is by means of a footswitch, attached via the back panel. Activation is inhibited by safety circuitry until both instrument and connector cable have been properly coupled to the SuperPulse Generator. An audible alarm will sound whenever electrosurgical energy is being output. Diagnostic circuits within the SuperPulse Generator continuously monitor system performance. Any detected faults are indicated as symbols on the user display in conjunction with the illumination of the front panel warning symbol. 1 C. Indication for Use The Gyrus ACMI PK Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated haemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment. 1D.

Contraindications for Use The use of this device is contraindicated in patients with the following conditions:   

Carcinoma of the bladder or prostate without tissue diagnosis. Patients with urinary tract infection. Patients with incipient renal failure.

It is advisable to monitor the input and output volumes of the irrigation fluid in all patients but especially those with cardiovascular insufficiency or poor renal function. Patients with Pacemakers Use with caution in the presence of internal or external pacemakers. Interference from an 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.

INTRODUCTION

1E.

System Description The SuperPulse Endourology System (figure 1.1) is designed for resectoscopic and endoscopic urological procedures performed on the lower urinary tract. A typical system comprises the following items:    

A SuperPulse Generator (Model 744000) A Gyrus ACMI Footswitch (Model 744010) Suitable connector cable to connect to the Gyrus or Olympus Resectoscope. Use only approved accessories - Contact your sales representative. When used with a PlasmaKinetic Resectoscope  A suitable Gyrus ACMI Urology Electrode (e.g. PK Plasma Sect, PK SuperSect, Superloop and PK Button) (see Fig 1.2)  When used with a suitable urological endoscope (e.g. Cystoscope)  A PK Plasma-Cise or PK Plasma Cut instrument (see Fig 1.3) When used with an approved Resectoscope  Olympus Electrodes – Compatible with the Gyrus ACMI SuperPulse System. Supplied with connector cable

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INTRODUCTION Typical Resectoscope Components Working Element Active - Or Working Element Passive Telescope Inner sheath Outer sheath - Or Outer sheath rotatable

SECTION 1

Standard Obturator Olympus Light Guide Adapter Visual Obturator Ellik Evacuator Adapter Continuous Flow Sheath Resectoscope Sheath (24 Fr. Intermittent Sheath)

The instruments are available in three basic forms. The resectoscope Instruments (figure 1.2) are designed to be used in conjunction with the PlasmaKinetic resectoscope which is designed to accept the instrument which is connected directly to the connector cable rather than to the resectoscope. Typical use of these types of instruments would be in the surgical treatment of benign prostatic hyperplasia. The cystoscope Instruments (figure 1.3) are intended for insertion through the working channel of any standard, commercially available urological endoscope with a 5Fr. or larger working channel. Typical use of these instruments would be for the desiccation and vaporisation of recurrent bladder tumours. In addition certain Olympus TURis instruments can also be used (see Fig 1.5) Instruments are designed to provide either vaporisation or desiccation of tissue, using the yellow and blue pedals respectively, of the dual footswitch. The vaporization is achieved with “SuperPulse” (SP) mode or “PlasmaKinetic” (PK) modes, depending on instrument type. Desiccation uses the Desiccated (DES) mode. A third mode is also available, the ThermoKineticTM mode (TS or T). This mode provides either modulated “SuperPulse” (TS) or a blend of PlasmaKinetic and Desiccate (T) electrosurgical currents and offers a reduced vaporisation effect but with enhanced hemostatic effect.

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Fig 1.1 Example System

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INTRODUCTION

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Fig 1.2 Example of Gyrus ACMI Resectoscopic Instruments – For use with Reusable Cable

SECTION 1 Fig 1.3 Example of Gyrus ACMI Resectoscopic instruments with Disposable Cable

INTRODUCTION

Fig 1.4 Example of Gyrus ACMI Cystoscopic Instruments.

Fig 1.5 Examples of Olympus Resectoscopic Instruments A specific TURis mode is only available when a TURis cable is connected to the SuperPulse Generator.

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PATIENT AND OPERATING ROOM SAFETY

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 electrosurgery in that procedure. 2A.

SECTION 2

For the purposes of safety procedures and despite the absence of a conventional return pad, the Gyrus ACMI SuperPulse Endourology System should still be treated as a high power electrosurgical device.

General Hazardous Electrical Output: This equipment is for use only by qualified personnel. Use only approved accessories.

WARNING

Do not use a monopolar generator/accessories simultaneously with the SP generator. Activation of a monopolar generator/accessories may cause interference with the SP generator resulting in user message changes on the 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.

WARNING

Direct contact between activated monopolar accessories and SP generator connected accessories could damage the SP generator. If such damage is suspected, the SP generator should be returned to Gyrus ACMI for inspection.

WARNING

Use with caution in the presence of internal or external pacemakers. Interference from an 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.

WARNING

Do not use electrosurgical equipment unless properly trained in its use in the specific procedure intended.

WARNING

Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if they are isolated. To reduce the risk of an inadvertent burn at the electrode site, place the electrode and / or probe as far away as possible from the electrosurgical site.

WARNING

ONLY USE 0.9% w/w SALINE FOR IRRIGATION. 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

CAUTION

If two accessories are connected to the SP generator, ensure the appropriate accessory is selected prior to activation. Activation of the unintended accessory could cause unintentional tissue effect.

CAUTION

Do not activate electrodes while in contact with other instruments as unintended tissue effect may occur.

CAUTION

Do not activate the generator in an open circuit condition, this may result in excessive heating of the irrigation medium. To reduce the risk of unintended effects, activate the generator only when the active accessory is near or touching the target tissue.

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WARNING

PATIENT AND OPERATING ROOM SAFETY

CAUTION

Do not apply excessive pressure to the accessory tip during use as damage may result.

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 Gyrus ACMI SuperPulse Endourology System accessories before use. This device is an integral system; only use approved accessories with the Superpulse Generator. Your sales representative can advise which accessories are available and approved for use with the Superpulse System.

CAUTION

If possible, avoid the use of needle style instruments 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 connector 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.

CAUTION

Examine all accessories and connections to the electrosurgical SuperPulse Generator before use. Improper connection may result in arcs and sparks, accessory malfunction, or unintended surgical effects.

CAUTION

Do not insert fingers or objects other than the correct cables into the socket. Only activate the footswitch with an instrument attached.

WARNING

The PK or SP system has not been cleared for tubal sterilization. Do not use this system for these procedures.

CAUTION

The Gyrus ACMI SuperPulse Endourology System should only be activated with the working tip of the instrument 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.

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PATIENT AND OPERATING ROOM SAFETY

2B.

Servicing/Equipment Disposal CAUTION

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

1. There are no user serviceable parts within the product. 2. For maintenance of the SuperPulse Generator refer to recommended periodic equipment safety checks in Section 13.

the

CAUTION

The SuperPulse 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 policies relating to obsolete electronic equipment.

CAUTION

Dispose of any system accessories according to normal institution practice relating to disposal of biologically contaminated items.

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PATIENT AND OPERATING ROOM SAFETY

Fire/Explosion Explosion Hazard: Do not use in the presence of flammable anaesthetics.

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)



Flammable agents used for cleaning or disinfecting, or as solvents of adhesives should be allowed to evaporate before the application of electrosurgery. There is a risk of pooling of flammable solutions under the patient or in body cavities during endoscopic surgery. Any fluid pooled in these areas should be mopped up before electrosurgery is used.



Endogenous gases.



Flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen enriched atmospheres.



Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of electrosurgical equipment.

The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. WARNING

2D.

Fire/Explosion Hazard: Verify that all oxygen circuit connections are leak free before and during use of electrosurgery. When using electrosurgery in the same room with any of the above substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is being performed.

Before Surgery Active Accessories WARNING

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

WARNING

Electric Shock Hazard: Ensure that all accessories are correctly connected and that no metal is exposed.

WARNING

Do not attempt to re-use instruments labelled for Single Use Only. Heat or chemical Sterilization may render the instrument mechanically or electrically unsafe

CAUTION

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

CAUTION

Accessories labelled re-usable must only be processed according to the recommended procedure and, where appropriate, recycled the specified number of times.

CAUTION

Use default power levels to test an accessory.

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SECTION 2

DANGER

PATIENT AND OPERATING ROOM SAFETY

CAUTION

Use only approved accessories supplied for use with this product. Product damage or accessory failure may otherwise result during use. Your sales contact can advise what accessories are available.

CAUTION

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

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SuperPulse Generator

PATIENT AND OPERATING ROOM SAFETY

2E.

WARNING

Electric Shock Hazard. Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters.

WARNING

Fire Hazard. Do not use extension cords.

CAUTION

Provide as much distance as possible between the SuperPulse Generator and other electronic equipment (such as monitors) as an activated SuperPulse Generator may cause interference with them.

CAUTION

Non-function of the SuperPulse Generator may cause interruption of surgery. Ensure that all installation procedures are followed and that all connectors are correctly inserted before use. A backup generator should be available for use.

CAUTION

Do not stack equipment on top of the generator or place the generator on top of electrical equipment.

CAUTION

Do not set the activation tone down to an inaudible level. The activation tone alerts surgical personnel when an accessory is active.

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 rigid endoscopes are metal. Do not activate the instrument while any portion of the instrument tip is within the sheath or working channel, or in contact with another metal object. Localised heating of the instrument and the adjacent metal object or working channel may result in damage to the contacting endoscope, and/or instrument 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, use extreme caution to maximise patient safety. The use of antistatic sheeting is recommended for this purpose.

WARNING

Risk of injury to patient: Thermal cell damage can occur when using preheated irrigation fluid. Always make sure that the temperature of the irrigation fluid does not rise above body temperature (37 °C/99 °F). Risk of injury to patient: Localised excessive heating of the irrigation fluid can be caused by HF current. Always make sure to use a sufficient flow rate (minimum 1 litre/5 min).

WARNING

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SuperPulse Generator Power Settings

CAUTION

Upon reconnection of an instrument to the electrosurgical SuperPulse Generator, or after navigation using the Mode / Menu button, the power settings for cutting and coagulation may be changed from previously selected values.

WARNING

Do not simultaneously activate the SuperPulse Generator whilst activating with any other electrosurgical equipment (on the same patient). Failure to observe this may result in the attached instrument being unrecognized by the system.

CAUTION

Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase or decrease in output power.

CAUTION

Use caution when overriding the default power settings.

CAUTION

Should a power supply interruption occur, the generator will revert to its Standby state. The user should press the Standby / On button to restart the generator and then press the Mode / Menu button to accept the default instrument settings.

Instrument Accessories WARNING

When not in use, place active instruments 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

Do not wrap accessory cords around metal objects. This may induce currents that could lead to injury to the patient or surgical personnel.

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.

Endoscopic Procedures WARNING

As visualisation may be impaired during endoscopy for a number of reasons, be particularly alert to these potential hazards: 

Ensure the tip of the instrument is visible before activation.



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



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



Localised 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 instrument, or by the active or return instrument being in close proximity to the conductive object whilst activated.

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Confirm proper power settings are displayed on the SuperPulse Generator before proceeding with surgery. Ensure the appropriate output setting is enabled for the desired surgical outcome before activating the instrument and ensure that activation is for the minimum time to achieve the desired surgical effect.

SECTION 2

WARNING

SECTION 2

SECTION 2 PATIENT AND OPERATING ROOM SAFETY

2F.

2G

PATIENT AND OPERATING ROOM SAFETY 

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



Only activate during intermittent or preferably continuous flow irrigation to ensure good visualisation and cooling of the instrument tip between activations.



The vaporisation process produces bubbles. Activation of the instrument tip within a bubble pocket may cause product damage.



Only use normal saline irrigation solution. Do not activate when not in contact with tissue, or excessive heating of the irrigation medium may result.



Tissue contact with the return instrument whilst the active instrument is surrounded by normal saline during activation may result in an electrosurgical effect occurring at the return instrument.

CAUTION

Proper use of the system relies on tissue contact with the active tip of the instrument only. Do not bury the tip in tissue beyond the junction of the active instrument and the ceramic insulator as product damage may result during use.

WARNING

Olympus TURis Mode Incorrect assembly and connection of the Olympus Resectoscopic system and electrode may result in no RF surgical output.

IMPORTANT

TURis compatibility is only available with SuperPulse software version V3.0 software and later.

After Surgery WARNING

Electric Shock Hazard. Always unplug the generator before cleaning.

CAUTION

Do not reuse or resterilize accessories labelled “disposable” or “single use only.”

EMC Classification The SuperPulse System has been manufactured and tested to the following requirements: Group 2 Class A as per IEC60601-1-2 (2001) 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 this document. EMC WARNINGS •

The generator should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary both the 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 SuperPulse 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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PATIENT AND OPERATING ROOM SAFETY

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

•

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

•

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

•

Do not use a monopolar generator/accessories simultaneously with the SuperPulse generator. Activation of a monopolar generator/accessories may cause interference with the SuperPulse generator resulting in user message changes on the 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.

•

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 generator, repositioning the generator, the connecting leads or other equipment may alleviate the problem. It may also help to use different electrical supply sockets for any affected equipment

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•

SECTION 2

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.

SECTION 3

INSTALLATION

The SuperPulse 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 endoscopic urological surgery under normal saline irrigation. 3A. Responsibility of the Manufacturer The manufacturer is responsible for safety, reliability and performance of the equipment only if:

SECTION 3



Installation procedures in this manual are followed.



Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorised 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 this User Manual, the Instructions For Use which accompany all system components and any additional information contained on the component package labelling.

3B. SuperPulse Generator Power Requirements Please refer to section 10-1 for full voltage detail. Check the SuperPulse Generator Power Connection The power connector meets all requirements for safe grounding. Its purpose should not be defeated by using extension cords or any form of adapter. When disconnecting from the mains socket or from the SuperPulse Generator, cords should always be grasped by the plug. Do not pull on the cord itself. 3C. Grounding of the SuperPulse Generator To ensure user safety the SuperPulse Generator must be properly grounded through the inlet plug and power cord. Use only hospital grade power cords.

INSTALLATION

IMPORTANT 3D.

Ensure that the electrical installation of the relevant room complies with local codes and regulatory requirements.

Routine Maintenance of the SuperPulse Generator It is recommended that the SuperPulse Generator be inspected by qualified service personnel in accordance with Section 13, Periodic Equipment Safety Checks.

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SECTION 4 4A.

GENERAL INFORMATION

Gyrus ACMI SuperPulse Generator Indicators and Displays

Red warning lamp

Gyrus Medical Ltd Superpulse System (c) 2003 Version V2.00

Standby / Standby / On On Button indicator

SECTION 4

PlasmaKinetic, SuperPulse and ThermoKinetic Up/Down

Mode / Menu Button

Active instrument indicator Connector Cable sockets

Vapor Pulse and Des Up/Down

Fig 4. 1 Keypad: Standby/On, Up, Down Arrows and Mode / Menu Button Standby / On

Following an error condition the generator may be reset by pressing the Standby / On button twice. Up/Down Arrows Depressing the up or down arrow when parameter change is permitted increases or decreases the parameter step-wise. Holding the button down will increase or decrease the value in preset steps Mode / Menu This button provides access into the waveform selection and setup menus. Repeated short presses will give access to the frequently used functions, listed below:   

Cut waveform selection (PK / SP) Coagulation waveform selection (VP / DES) Volume

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GENERAL INFORMATION

The Standby/On button switches the Generator back and forth between the Standby and Idle / Ready states. The green indicator will change from flashing to continuous when the equipment mode changes from Standby to Idle / Ready states by pressing the button. To place the generator into Standby press the standby button. When prompted press again to confirm entry to Standby is required

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GENERAL INFORMATION

A long press will give access to the setup menu, giving access to the following functions below with repeated short presses:     NOTE

Display intensity Key click on/off Select language Enter PIN Code If there is no user activity for a short period, the generator will exit the menu and return to Idle / Ready state.

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When a PK connector cable is attached, the symbol below appears on the display.

3 Way Cable Attached Insert Device

Fig 4.2 Screen for 3-Way PK cable installed on the selected socket. Output Displays for SP/ PK Instruments

GENERAL INFORMATION

The display is split into two halves; the upper portion of the display is used to indicate the type of instrument active, that is the instrument that will provide an output when the Cut or Coag pedal is pressed. The lower half of the display indicates the output waveform type, or mode, and the power selected. The left lower portion displays the mode selected and, underneath, the power level that will be active when the Cut pedal is depressed. This is dependent upon the type of instrument used, its default setting properties and any user power level adjustments. When a Plasmakinetic (PK) instrument is used one of ‘PK1’, ‘PK2’ or ‘PK3’ is shown for the mode, the power setting can be from 10 to 200. When a SuperPulse (SP) instrument is used one of ‘SP1’, ‘SP2’, ‘SP3’ is shown for the mode, the power setting can be from 10 to 320. When the ThermoKinetic mode is selected ‘TS1’, ‘TS2’, ‘T1’ or ‘T2’ is shown. The right portion displays desiccate (VP or DES), with the default power setting from 10 to 120 dependent on the type of Gyrus ACMI PK instrument attached. This is the power level that will be active when the Coag pedal is depressed. The appropriate display will flash and an audible alarm will sound when an output is activated.

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GENERAL INFORMATION

SuperLoop SP2 160

Des 80

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Fig 4.3 Screen for SuperLoop instrument selected Output Displays for SP Instruments The display will operate as per PK instruments with the PK waveforms replaced by their SP alternates. IMPORTANT

4B.

SuperPulse (SP) mode can only be used with Gyrus ACMI SuperPulse compatible instruments (SuperSect, SuperLoop and SuperV instruments).

Output Mode Selection and Power Controls

Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the PlasmaKinetic (PK), SuperPulse (SP) and ThermoKinetic (T and TS) outputs and the blue arrow buttons for the Vapor Pulse Coagulation (VP) and Desiccate (DES) output. Press the appropriate button once for a power increment or decrement. Holding down the button accelerates the incrementing or decrementing. NOTE

Power can only be adjusted once an instrument is properly connected to the generator. When using Gyrus ACMI instruments default output power and power range limiting is set appropriate to that instrument.

SuperPulse Cut

SP3 SP2 SP1

Difficult high flow conditions and/or High impedance Moderate flow conditions Low flow conditions  Voltage increasing

PlasmaKinetic PK3 Cut PK2 PK1

High impedance tissue (fatty, vascular tissue) Medium impedance tissue Low impedance tissue (thin tissue)  Voltage increasing

ThermoKinetic Cut (T) T2 T1

High impedance tissue (fatty, vascular tissue) Low impedance tissue (thin tissue)  Voltage increasing

(TS)

TS1 TS2

Moderate tissue vascularity Higher tissue vascularity

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

Hemostasis decreasing

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GENERAL INFORMATION

When using a Gyrus ACMI instrument, the connected instrument is automatically sensed by the generator and the default power for that instrument will be selected.

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GENERAL INFORMATION

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Coagulation

DES VP3 VP2 VP1

General purpose, Non tissue-specific desiccation High impedance tissue (fatty, vascular tissue) Medium impedance tissue Low impedance tissue (thin tissue)  Voltage increasing

NOTE

Output mode selection can only be performed with an instrument and connector cable attached to the generator. The range of modes available will depend on the type of Gyrus ACMI PK instrument being used.

NOTE

If the Mode / Menu button is quickly pressed and released the generator enters a menu based configuration state, pressing and holding the Mode / Menu button at any time exits this state.

NOTE

The PK output is not available for some PK instruments. The lower left hand portion of the display remains blank in this case.

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GENERAL INFORMATION

Mode Selection using Gyrus ACMI PK/SP Instruments - There are three PlasmaKinetic Modes shown as PK1, PK2 and PK3, which produce a tissue effect increasing from PK1 to PK3 (PK3 delivers power more effectively to higher impedance tissue than PK1). Two of the ThermoKinetic outputs available, shown as T1 and T2, continuously switch between a PlasmaKinetic and Desiccate output during activation. These ThermoKinetic outputs will provide a greater degree of hemostasis during tissue cutting compared to a PK setting. Three VP mode levels and the desiccate (DES) are available.

For instruments that support the SuperPulse waveform the PK modes are replaced by SP modes SP1, SP2, and SP3, producing an increasing tissue effect from SP1 to SP3. The SuperPulse modes provide high-energy pulses promoting rapid generation of the plasma corona around the active electrode. Once the plasma corona is established the output reverts to a continuous wave. The SP equivalents of the T1 and T2 ThermoKinetic outputs, TS1 and TS2 rely on selective modulation of the SP2 SuperPulse waveform, to provide a higher crest factor and therefore increased hemostasis.

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VP1 is optimal for low impedance tissue, VP2 for intermediate impedance tissue and VP3 for higher impedance tissue or larger diameter instruments. The frequency of pulses in VP mode will also vary depending on the type of instrument attached: generally, the larger the tissue contact area, the slower the pulses. DES provides a conventional continuous bipolar output.

The waveforms associated with the blue and yellow pedals can be individually assigned. To change the waveform press the Mode / Menu button until the option to change the waveform required is seen on the display (yellow pedal waveforms appear on the LHS and blue pedal waveforms on the RHS). TURis Mode for Olympus TURis Electrodes The Gyrus ACMI SuperPulse System supports compatibility with the Olympus TURis Resectoscopic System. When the supplied TURis cable is connected, the generator will automatically provide the default settings. Modify the settings for the connected instrument to achieve the desired tissue effect. TP Mode – Provides vaporisation/ cutting yellow pedal outputs for use with the Olympus TURis Electrodes (TP3 setting is more aggressive than TP1) Refer to the instructions for use supplied with the compatible TURis Electrode range and the Olympus Resectoscope. DES provides a Blue pedal coagulation output. The outputs can be adjusted in the same manner as described in section 4B to suit physician preferences.

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GENERAL INFORMATION

4C.