PlasmaKinetic SuperPulse Generator User Manual Feb 2011

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PlasmaKinetic SuperPulse Generator

USER MANUAL

Manufactured for:

Gyrus ACMI,

136 Turnpike Road

Southborough

MA 01772-2104

USA

Gyrus Medical Ltd

St Mellons

Cardiff

CF3 0LT

United Kingdom

0344

Rx only

Customer Service USA:

Customer Service: 1-888-524-7266

Technical Service: 1-800-621-3739

www.gyrusacmi.com

744000

Part Number: 114020-LB

2011-02

Page 3

………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

Copyright

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SECTION 1

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

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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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SECTION 1

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

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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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

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INTRODUCTION

Fig 1.1 Example System

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SECTION 1

INTRODUCTION

.

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

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SECTION 2

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

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PATIENT AND OPERATING ROOM SAFETY

WARNING

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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.

SECTION 2

SECTION 2

PATIENT AND OPERATING ROOM SAFETY

WARNING

CAUTION

2B.

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

system for these procedures.

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.

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

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SECTION 2

2C.

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

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PATIENT AND OPERATING ROOM SAFETY



SECTION 2

DANGER

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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.

SECTION 2

SECTION 2

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

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PATIENT AND OPERATING ROOM SAFETY

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

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PATIENT AND OPERATING ROOM SAFETY

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

Page 14

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

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PATIENT AND OPERATING ROOM SAFETY

•

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.

Page 16

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 3-1

Page 17

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-1

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

Page 18

SECTION 4

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.

SECTION 4

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-2

Page 19

SECTION 4

GENERAL INFORMATION

SuperLoop

SP2

160

Des

80

SECTION 4

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

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL



Hemostasis

decreasing

Page 4-3

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.

Page 20

SECTION 4

GENERAL INFORMATION

SECTION 4

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.

GENERAL INFORMATION

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-4

Page 21

SECTION 4

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.

SECTION 4

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.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-5

GENERAL INFORMATION

4C.

Page 22

SECTION 4

GENERAL INFORMATION

Using the UP/DOWN buttons as indicated on the screen, will cycle through the available

waveforms for the respective pedal (see Fig. 4.4 below).

When the desired mode is displayed a further press on the Mode / Menu button will

complete the selection

Select

Mode

SECTION 4



DES



Fig 4.4 Screen for coag waveform selection

Socket Selection

The generator permits two instruments to be fitted simultaneously, via the two 5-way

connectors.

GENERAL INFORMATION

Only one socket can deliver RF at any one time. When the generator is switched on from

the Standby state, it initially operates an automatic socket selection mechanism, and

assists primary connection by activating whichever socket first has an instrument attached.

The instrument connected to the active socket is indicated on the display. Thereafter socket

selection can only be altered manually, by pressing the black mode footswitch, ensuring

that the surgeon always has control over which instrument is activated.

Black Mode

Footswitch

Fig 4.5 Footswitch

Footswitch - Blue Pedal

The blue footswitch pedal is used to administer desiccate and VP output waveforms. The

output will be present while the footswitch is held down.

Footswitch – Yellow Pedal

The yellow footswitch pedal is used to administer ThermoKinetic and PK/SP (cut)

waveforms. The output will be present while the footswitch is held down.

Footswitch – Black Mode Footswitch

The black mode footswitch enables a rapid change between instruments.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-6

Page 23

SECTION 4

GENERAL INFORMATION

Generator Switch On/Off

The mains power On/Off rocker switch is located on the top left of the rear panel (viewed

from front). The Generator is switched on by pressing the side marked l. The generator will

display the Serial number of the generator, then the internal tests are performed then the

green LED below the Mode / Menu button will come on continuously, and then flash after a

short time. The generator is then in Idle state.

The generator display will dim after a period of 30 minutes of not being used and will

automatically enter Standby state if it is not used for a period of four hours.

It is advisable to switch off the Generator whenever it is not in use for any extended period,

by using the rear panel switch. The side marked “0” should be pressed to do this.

If an instrument is present at switch on then the user has to accept the default powers, by

pressing the Mode / Menu button when prompted.

4D.

SuperPulse Generator Indicators, Set-up and Malfunction Displays

SECTION 4

To enable use of the generator the Standby / On button must be pressed and the generator

will then enter the idle state if no instrument is fitted or the Ready state if an instrument is

fitted.

Volume Adjustment - The activation tone volume can be adjusted between minimum and

maximum using the up control of the desiccate (blue) power control. Depress and release

the Mode / Menu button until the symbol “SELECT VOLUME” appears (Fig. 4.6). Press

and release the Mode / Menu button once more to accept the setting.

volume



10



1

Fig 4.6 Screen for Alarm volume selection

System Failure Displays

Non-critical (Soft) Faults

Shorting - For Gyrus ACMI Urology instruments, if a Generator “Output Shorted” message

occurs the power will be removed for 0.5 seconds and the activation tone will also be

terminated for this time. If the pedal is kept depressed, RF activation will resume. If three

short circuits occur in 2 seconds then RF activation is stopped until the pedal is released

and pressed again. Power levels will remain the same as those previously in use.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-7

GENERAL INFORMATION

Select

Page 24

SECTION 4

GENERAL INFORMATION

OUTPUT

SHORTED

RE-APPLY

PEDAL

SECTION 4

Fig 4.7 Screen for the selected SP electrode shorted

Storage at low temperatures – The generator will detect where the enclosure temperature

is below the specified minimum allowable for use, and will display a ‘WARMING UP”

message until an acceptable temperature is reached internally, whereupon normal

operation will resume. This condition is possible where the generator has been brought

directly into the operating room from a cold storage environment.

WARMING UP

GENERAL INFORMATION

Fig 4.8 Screen for an excessively cold condition

Foot pedals stuck on – The generator will detect where one or more the foot pedals

appears to be stuck on, and will wait until the condition disappears before resuming normal

behaviour. This condition can be inadvertently caused by inverting the footswitch or

standing on a pedal as the generator is switched on.

CHECK

IRRIGANT/CABLE

Fig 4.9 Saline Detection Mode in TURis Mode Only

If the SuperPulse Generator is activated when the electrode is not in saline or with only

one Resectoscopic cable connection present the above message will be displayed. No

RF output will occur.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-8

Page 25

SECTION 4

GENERAL INFORMATION

Non-critical (Recoverable) Faults

Fault - If a fault is detected during set-up or during use a fault code message is displayed

as indicated by the “Fault Code X00 REF XX” symbol on the front panel display (Fig 4.10

Screen for recoverable fault display). Refer to Section 9, Operating Room

Troubleshooting.

BUTTON

STUCK

SECTION 4

Fault code

400

Ref

15

Fig 4.10 Screen for recoverable fault display

Critical (Non-recoverable) Errors

INTERNAL

FAILURE

Error code

200 Ref 25

Fig 4.11 Screen for critical error display

SuperPulse Generator Connectors and Sockets

The PK Three Way connector cable is connected to the generator through either of the two

PK connector cable socket on the front panel of the generator (figure 4.1).

The SuperPulse function is only available through the right hand socket and the SuperPulse

instruments must therefore be connected to this socket. Olympus TURis mode is only

available from this socket.

The mains power cord; footswitch cable and protective earth cable are connected to the

generator through fittings on the rear panel.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-9

GENERAL INFORMATION

Red Warning Symbol - Except during the self-test routine and a non-critical failure,

illumination of the red warning symbol on the front panel when accompanied by the

“ERROR XXX REF XX” symbol (Fig 4.11 Screen for critical error display) on the front

panel display indicates a critical failure. In the case of a critical failure, DO NOT ATTEMPT

TO USE THE UNIT. Please refer to Section 11 for information.

Page 26

SECTION 4

4E.

GENERAL INFORMATION

CHANGING THE DISPLAY LANGUAGE

From the SuperPulse generator idle state (with the VFD screen showing the “Connect PK

Cable” or “X Way Cable Attached Insert Device” message), press and hold for 3 seconds

the Mode / Menu button on the SuperPulse front panel.

The SuperPulse generator VFD screen will show the “Display Intensity” message, press

and release the Mode / Menu button twice so the following screen is displayed.

Select Language

SECTION 4



English



Fig 4.12

Use the right hand arrow buttons to change the language as required. Press and hold the

Mode / Menu button down to return to the previous state.

GENERAL INFORMATION

Once the language has been changed from the factory default of English, the SuperPulse

will continue to use the selected language for all instructions, performance information

and error messages on the generator VFD display.

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

Part Number: 144020-LB

USER MANUAL

Page 4-10