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SECTION 2 PATIENT AND OPERATING ROOM SAFETY

Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology)

USER MANUAL

Part Number: 144020-LB



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.

2F. 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.”

2G 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.

Page 2-6

SECTION 2

PATI

ENT AND OPERATING ROOM SAFETY

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Содержание PlasmaKinetic

Страница 1: ...s ACMI 136 Turnpike Road Southborough MA 01772 2104 USA Gyrus Medical Ltd St Mellons Cardiff CF3 0LT United Kingdom 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 0344 ...

Страница 2: ......

Страница 3: ...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 23...

Страница 4: ...Malfunction Displays 4 7 4E Changing the Display Language 4 10 4F Enabling Additional Instruments via a PIN code 4 11 5 BEFORE SURGERY 5A Power up the SuperPulse Generator 5 1 5B Select the Appropriate PK SP Instrument s for the Procedure 5 2 5C Steam Sterilise the PK Connector Cable PlasmaKinetic Resectoscope or appropriate urological endoscope 5 4 5D Connect the PK Connector Cable 5 4 5E Prepare...

Страница 5: ...rmation of the plasma enabling easier and more rapid resection of tissue 1B Comparison with Conventional Electrosurgery 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 sali...

Страница 6: ... 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 func...

Страница 7: ...atment 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 ...

Страница 8: ...c Instruments For use with Reusable Cable Fig 1 3 Example of Gyrus ACMI Resectoscopic instruments with Disposable Cable 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 SECTION 1 INTRODUCTION Page 1 4 ...

Страница 9: ... 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 ma...

Страница 10: ...s 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 ...

Страница 11: ...l equipment The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times WARNING 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 surgica...

Страница 12: ... set the activation tone down to an inaudible level The activation tone alerts surgical personnel when an accessory is active 2E 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 w...

Страница 13: ...or 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 th...

Страница 14: ... 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 2F After Surgery WARNING Electric Shock Hazard Always unplug the generator before cleanin...

Страница 15: ...e 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 ...

Страница 16: ...ny 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 disco...

Страница 17: ...owing 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 presse...

Страница 18: ...he 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 sho...

Страница 19: ...s 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 ...

Страница 20: ...ection 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 av...

Страница 21: ...e 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 The waveforms associated wi...

Страница 22: ...on 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 Fig 4 5 Footswitch Footswitch Blue Pedal Th...

Страница 23: ... will then enter the idle state if no instrument is fitted or the Ready state if an instrument is fitted 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 Volume Adjustment The activation tone volume can be adjusted between minimum and maximum usin...

Страница 24: ...erating room from a cold storage environment 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 o...

Страница 25: ...l 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 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 ca...

Страница 26: ...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 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 Once the language has been changed from the factory default of English the SuperPulse will c...

Страница 27: ... will remember that PIN and continue to allow the use of these instruments even after it has been switched off This facility can be setup in one of two ways Note If the PIN number entry screen cannot be accessed contact your local sales representative or alternatively contact Customer Services as detailed at the front of this manual a Without instrument available at the time of PIN entry This opti...

Страница 28: ...N Entry screen is left displayed for two minutes at any time without any buttons being pressed the SuperPulse will return to its default screen Connect PK Cable or Insert Device and the PIN entry process will have failed and will need to be repeated b With Instrument available at time of PIN entry This allows the instrument to be enabled at the start of the surgery if it has not been done previous...

Страница 29: ...ice to this port 2 Equipotential Connector The connection for the Potential Equalization Conductor terminates at this point 3 Power Switch Switch to turn the Generator on off 7 Fuse Label Provides information on correct fuse to use for fuse replacement 4 Footswitch Connector The Footswitch is used to initiate the RF On Mode 5 Fuse Compartment Location of line fuses WARNING Replace only with T seri...

Страница 30: ...tre activity Provide at least four inches of space from the rear of the SuperPulse Generator Never cover the SuperPulse Generator or stack other equipment on top of it It is normal for the SuperPulse Generator to become warm during use so ensure adequate ventilation Connect the SuperPulse Generator Plug the supplied AC power cord into the receptacle on the rear of the SuperPulse Generator and then...

Страница 31: ...upplied Instruction for Use PlasmaKinetic Resectoscope and PlasmaKinetic SuperSect Loop Resectoscope Instruments The PlasmaKinetic Resectoscope Instruments require that both poles of the electrosurgical circuit be connected to the instrument As conventional monopolar resectoscopes are only equipped to accept one electrical connection the PlasmaKinetic Resectoscope instrument must be used with a Pl...

Страница 32: ...nto two categories Coiled active tips primarily intended to provide vaporisation and instantaneous coagulation of tissues figure 5 3a Wire active tips primarily intended to provide cutting of soft tissues NOTE Specific information regarding the instrument classification codes are provided on the instrument package labelling 5C Steam Sterilise the PK Connector Cable PlasmaKinetic Resectoscope or ap...

Страница 33: ...n include changes in internal diameter which may obstruct free passage If the free passage of the instrument is obstructed remove and try again rather than trying to force the instrument tip past the obstruction Using force to overcome obstruction will result in damage to the instrument tip and risk malfunction or breakage during use 5E Attaching PlasmaKinetic Instrument via the PK Connector Cable...

Страница 34: ... Failure to do this will cause malfunction of the equipment Avoid activation of the instrument within a working channel or operating sheath Bubbles are produced during tissue vaporisation which may interrupt surgery by temporarily interfering with vision Sufficient flow of irrigant is recommended to ensure that these bubbles are flushed away from the field of view and from the area surrounding the...

Страница 35: ...tissue effects observed with T1 and T2 are to a large degree dependant on the nature of the tissue being treated As a generalisation however T1 produces a superficial blanching of tissue with little to no vaporisation while T2 produces a level of vaporisation equivalent to PK1 with an enhanced haemostatic effect Instruments that use the SP mode also have access to two additional ThermoKinetic outp...

Страница 36: ...owing the X Way Cable Attached Insert Device symbol where X is 3 or 5 depending upon cable type connected Fig 4 2 Screen for 3 Way PK cable installed on the selected socket Inserting a new PlasmaKinetic instrument configuration will reset the SuperPulse Generator to the default settings for that specific instrument Unless the instrument has the same identification code any adjustments to the Super...

Страница 37: ...ide to side surface application rather then the conventional proximal to distal cutting action of a monopolar loop If more vascular or glandular prostatic tissue is encountered one of the four ThermoKinetic modes can be selected to increase collateral thermal effect at the resection margin The maintenance of good irrigation flow during resection is important to remove the bubbles and particulates ...

Страница 38: ...heavily soiled it is recommended that they are pre washed manually Manual washing should be carried out using a soft sponge or brush and a mild cleaning solution or detergent capable of removing organic deposits f The lumen of both inner and outer sheaths should be cleaned thoroughly using an appropriately sized brush Particular attention should be paid to the inlet and outlet nozzles and also the...

Страница 39: ...ectrically unsafe WARNING Exceeding the recommended number of uses may result in electrical or mechanical failure during use or difficulty when attaching or detaching the instrument to or from the reusable connector cable Clean the Footswitch a Disconnect the footswitch from the rear panel of the SuperPulse Generator by first unlocking the retaining ring by rotating in an anti clockwise direction ...

Страница 40: ... that sufficient ventilation is provided around generator Ensure ambient temperature is within operating limits Generator displays Press mode to use when attempting to activate The generator has detected external interference and requires user confirmation of the instrument type Press either the Mode Menu button on the generator or the black mode footswitch to confirm Note any confirmation will on...

Страница 41: ...is is an activation signal only Classification Class 1 IEC 60601 1 Electromagnetic Compatibility Complies with IEC 60601 1 2 Defibrillator Proof Type BF equipment with isolated F applied part Each of the instrument terminals can withstand the effects of a defibrillator discharge Liquid Spillage as per IEC 60601 2 2 The SuperPulse Generator enclosure will prevent reasonable amounts of liquid from i...

Страница 42: ...Peak T2 480 Volts Peak DES 170 Volts Peak VP1 103 Volts Peak VP2 141 Volts Peak VP3 170 Volts Peak TP1 360 Volts Peak TP2 397 Volts Peak TP3 434 Volts Peak CAUTION The following load curves apply to the fundamental power delivery capability of the SuperPulse Generator alone They do not imply a given power output for any given instrument and connector cable configuration when used with the SuperPul...

Страница 43: ...Curves 0 10 20 30 40 50 60 70 0 500 1000 1500 Load Resistance Power Des VP1 VP2 VP3 Half Power Cut Load Curves 0 20 40 60 80 100 120 0 500 1000 1500 Load Resistance Power PK1 PK2 PK3 T1 T2 Half Pow er SPLoad Curve 0 50 100 150 200 250 300 350 0 200 400 600 800 1000 Load Resistance Power SP1 SP2 SP3 TS1 TS2 Half Power Load Curves SECTION 10 PERFORMANCE SPECIFICATIONS ...

Страница 44: ...50 100 150 200 250 300 350 0 200 400 600 800 1000 Load Resistance Power SP1 SP2 SP3 TS1 TS2 Full Power Coagulate Load Curves 0 20 40 60 80 100 120 140 0 500 1000 1500 Load Resistance Power Des VP1 VP2 VP3 Full Power Cut Load Curves 0 50 100 150 200 250 0 500 1000 1500 Load Resistance Power PK1 PK2 PK3 T1 T2 Full Power Load Curves SECTION 10 PERFORMANCE SPECIFICATIONS ...

Страница 45: ...ltage limits VP3 120Vrms VP2 100Vrms VP1 73Vrms The output power is defined as follows CycleTime OnTime PeakPower er AveragePow Where the Peak power is constant the cycle time the time for a complete on off period is preset and the On Off ratio is varied dependent on set power 0 20 40 60 80 100 120 140 0 100 200 300 400 500 600 700 800 900 1000 Load Resistance R Power TP1 TP2 TP3 TURis Cut Mode Ha...

Страница 46: ...maximum output voltages During off periods no RF output occurs Repetition rates will vary with impedance above 330 giving continuous operation The output power for given load is defined as follows CycleTime OnTime PeakPower er AveragePow Where the Peak Power into a given load is constant and both the Cycle Time and the On Time varies dependent on set power and load impedance SECTION 10 PERFORMANCE...

Страница 47: ...ol is displayed as for the recoverable faults except that it indicates that a service is required WARNING An error symbol indicates an equipment malfunction which may be hazardous Disconnect all accessories and switch the Generator off Switch the Generator back on and if the self test is completed satisfactorily as evidenced by the Attach PK Cable symbol on the display the failure occurred in the ...

Страница 48: ...ermanently ON 200 26 INTERNAL FAILURE F ENERGY signal error stuck low 200 27 Not used 200 28 INTERNAL FAILURE S Temperature monitor inoperative 200 29 Reserved for audio fault detection 200 30 Not used 200 31 INTERNAL FAILURE F CURRLIM signal error DAC output 200 32 INTERNAL FAILURE F VOLTLIM signal error comparator input 200 33 INTERNAL FAILURE F BUSVOLTS signal error analogue input 200 34 INTERN...

Страница 49: ...re POST check 200 75 INTERNAL FAILURE F SPRF_ACTIVE failure POST check 200 76 INTERNAL FAILURE F VCC_ANA_DIV_2 failure POST check 200 77 INTERNAL FAILURE F 12V failure POST check 200 78 INTERNAL FAILURE F 0V failure POST check 200 80 INTERNAL FAILURE F RF_VOLTAGE POST check 200 81 INTERNAL FAILURE F RF_CURRENT failure POST check 200 82 INTERNAL FAILURE F ANALOGUE_REF failure 200 83 INTERNAL FAILUR...

Страница 50: ...UT left UP button stuck 400 16 BUTTON STUCK R Front panel CUT left DOWN button stuck 400 17 BUTTON STUCK R Front panel blue UP button stuck 400 18 BUTTON STUCK R Front panel blue DOWN button stuck 400 19 BUTTON STUCK R Front panel MODE MENU button stuck 400 20 BUTTON STUCK R Front panel STANDBY button stuck 400 21 FOOTPEDAL STUCK R Footswitch pedal state indeterminate 400 26 CHECK IRRIGANT ELECTRO...

Страница 51: ...otection against electric shock to TYPE B as defined in IEC60601 1 This equipment has an F type applied part capable of withstanding the effects of defibrillator discharge This symbol indicates the conductor that may be used to provide potential equalization between the equipment and the installation busbar This symbol indicates the receptacle to which the generator footswitch should be attached W...

Страница 52: ...y of devices inside the package Numeral corresponds to the number of devices inside the package and must be present inside the diamond icon Represents the quantity of salable units inside the package CAUTION Federal Law USA restricts this device to sale by or on the order of a Physician or Dentist When a product is manufactured for Gyrus ACMI SECTION 12 EXPLANATION OF SYMBOLS ...

Страница 53: ...e functioning normally via the user verification sequence which follows initialization Check Desiccation detector operation Check that the enclosure earth leakage current is within the limits for Class I equipment as prescribed within EN 60601 1 or the corresponding national standard as appropriate Measure the patient earth leakage currents and ensure it is within the limits of BF type equipment a...

Страница 54: ...urology USER MANUAL Part Number 144020 LB Page 13 2 Details of these tests should be recorded in an equipment log with the date of test for future reference Contact the service repair centre selected by the manufacturer should a unit fault be suspected SECTION 13 PERIODIC EQUIPMENT SAFETY CHECKS ...

Страница 55: ...etic Environment Guidance RF Emissions CISPR 11 Group 1 The SuperPulse Generator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A Harmonic Emissions IEC 61000 3 2 Class A Voltage Fluctuations Flicker Emissions IEC 61000 3 3 Complies The SuperPulse Generator...

Страница 56: ...ent Surge IEC 61000 4 5 1 kV Differential Mode 2 kV Common Mode 1 kV Differential Mode 2 kV Common Mode Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 5 UT 95 Dip in UT for 0 5 Cycle 40 UT 60 Dip in UT for 5 Cycle 70 UT 30 Dip in UT for 25 Cycle 5 UT 95 Dip in UT f...

Страница 57: ...metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagatio...

Страница 58: ...Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres ...

Страница 59: ... on the part of the manufacturer The manufacturer neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of the manufacturer s products Notwithstanding any other provision herein or in any other document or communication The manufacturer s liability with respect to this agreement and products sold hereunder shall be limited to...

Страница 60: ...NI PAR VOTRE FOURNISSEUR NE PAS UTILISER D AUTRE TYPE DE CORDON D ALIMENTATION WARNING ATTENTION RISK OF FIRE REPLACE FUSE AS MARKED RISQUE D INCENDIE REMPLACER LE FUSIBLE COMME INDIQUE THE POWER SUPPLY CORD PROVIDED IS INTENDED FOR NORTH AMERICAN 110V USE THIS POWER CORD IS UL LISTED TYPE SJT RATED 120V AT 10A MINIMUM FOR OPERATION AT OTHER MAINS SUPPLY VOLTAGES CONSULT YOUR LOCAL PRODUCT REPRESE...

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