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PK Superpulse User Manual 2

1. N gt gt es lt t NOILOAS G gt es Z gt Z J a gt es e gt Z G gt lt N gt pa es lt 2B Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology Part Number 144020 LB AUTIO AUTIO AUTIO O AUTIO Zz AUTIO AUTIO lt lt AUTIO O AUTIO lt AUTIO lt O AUTIO lt WARNING CAUTION PATIENT AND OPERATING ROOM SAFETY Do not apply excessive pressure to the accessory tip during use as damage may result Use the lowest appropriate power setting to achieve the desired effect This equipment is capable of producing a physiological effect 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 If possible avoid the use of needle style instruments for any physiological monitoring equipment that may be connected to the patient during electrosurgery Where practical only use monitoring equipment that incorporates high frequency current limiting devices during electrosurgical procedures The connector cable should be positioned so that it avoids contact with the patient and any other leads Studies have
2. MN SECTION 14 EMC TABLES x Guidance and Manufacturer s Declaration Electromagnetic Immunity x The SuperPulse Generator is intended for use in the electromagnetic environment specified below The customer or the user of the SuperPulse Generator should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Level Electromagnetic Environment Level Guidance Floors should be wood concrete Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 NOTE Uris the a c mains voltage prior to application of the test level 6 kV Contact 8 kV Air 2 kV for Power Supply Lines 1 kV for Input Output Lines 1 kV Differential Mode 2 kV Common Mode lt 5 UT gt 95 Dip in Ur for 0 5 Cycle 40 Yo Ur 60 Dip in U for 5 Cycle 70 UT 30 Dip in U for 25 Cycle lt 5 UT gt 95 Dip in Ur for 5 sec 6 kV Contact 8 KV Air 2 kV for Power Supply Lines 1 kV for Input Output Lines 1 kV Differential Mode 2 kV Common Mode lt 5 Yo UT gt 95 Dip in Ur for 0 5 Cycle 40 Yo UT 60 Dip in Ur for 5 Cycle 70 Yo UT 30 Dip in Ur for 25 Cycle lt 5 Yo UT gt 95 Dip in Ur for
3. Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 10 6 SECTION 11 ERROR AND FAULT CODES Fault and Error Symbol Interpretation Most technical problems are indicated by either a fault or error symbol that appears in the Generator display window Three levels of failure reporting exist within the generator A Soft S Fault describes events bringing the attention of the user to an attempt to use the Generator outside the specification This will be annunciated by a warning beep A Recoverable R Fault describes a condition that is a transient non hazardous event recoverable using a Generator reset function To reset the Generator after a fault occurs first depress and release the Mode Menu button once The fault symbol on the display should flash Depress and release the Mode Menu button once more to complete the reset II NOILOAS The symbol on the display will be of the form The symbol on the display will be of the form FAULT CODE X00 REF XX Wiehan Remember to take note of the fault symbol for reporting to a service engineer before completing the reset A Fatal F Error describes a failure that is not recoverable An error symbol is displayed as for the recoverable faults except that it indicates that a service is required An error symbol indicates an equipment malfunction which may be hazardous Disconnect all accessories and
4. 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 interfering with the generator s safe and satisfactory operation Intermittent operation The SuperPulse Generator is cooled by natural convection Under maximum power setting and rated load conditions the SuperPulse Generator will provide full power output with the minimum constraint of 10 seconds on 30 seconds off duty cycle for 1 hour Output Waveform and Characteristics Waveform The RF output is a variable amplitude sinusoid waveform varying between approximately 340 kHz and 450 kHz corresponding to minimum and maximum load impedance respectively Crest Factor A constant crest factor of 1 4 nominal for all outputs except VP TS T and SP Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 10 1 01 NOILOAS G lt e P e lt gt Z e N a gt es e e gt p Z N 01 NOLDOUS a gt es e e lt gt Z e N E e pd n e gt pd Z N SECTION 10 PERFORMANCE SPECIFICATIONS Power Maximum power 200 watts into 400 ohms PK Maximum
5. 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 ARNING 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
6. GYRUS ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Manufactured for Gyrus ACMI 136 Turnpike Road Southborough MA 01772 2104 USA Gyrus Medical Ltd St Mellons Cardiff CF3 OLT United Kingdom Sa 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 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 Copyright Patents 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 This product may be covered by one or more of the following US patents 0 944 715 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
7. Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Overview of the SuperPulse System 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 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
8. IR Front panel CUT left DOWN button stuck FOOTPEDAL STUCK Footswitch pedal state indeterminate IIT NOILOAS Generated if a TURis electrode is attached and activated without a saline solution being present or there is an electrode connection fault Serial port error Not used SERIAL COMMS To report an accessory failure contact the appropriate address located on the front of the manual for assistance es e e e gt Z J pe gt lt e es DN Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 11 4 SECTION 12 EKPLANATION OF SYMBOLS Red Warning Symbol Attention consult accompanying documents 4 BANCO ROI be This equipment intentionally emits RF energy during activation This equipment provides a degree of protection 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 Waste electrical and electronic equipment WEEE SITO WAS JO NOLLVNV Td Xa Storage Conditions Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 12 1
9. 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 QO lt Z es e gt a Z e lt gt Z Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 7 SECTION 4 GENERAL INFORMATION OUTPUT SHORTED RE APPLY 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 b NOILILOHAS WARMI NG UP 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
10. SECTION 12 EKPLANATION OF SYMBOLS Represents the guantity of devices inside the package Numeral corresponds to the number of devices inside the WY package and must be present inside the diamond icon QTY Represents the quantity of salable units inside the package 4 BNO ROI t Manufactured for When a product is manufactured for Gyrus ACMI Rx only CAUTION Federal Law USA restricts this device to sale by or on the order of a Physician or Dentist es gt a gt gt Z gt Z pza N a Z m N Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB SECTION 13 PERIODIC EQUIPMENT SAFETY CHECKS The manufacturer recommends that the Generator and Footswitch should be regularly inspected to ensure continued safety of operation throughout its service life The following safety checks should be performed at least every 12 months by a qualified person who has adequate training knowledge and practical experience to perform such tests lt pleas here are no user serviceable items within the generator e Inspect the Generator and the Footswitch for obvious signs of mechanical damage or jami wear Ensure that the Generator case shows no sign of tampering There are no user serviceable items within the Generator or Footswitch Z Check that the Generator back panel label is present and decipherable and that the front panel markings and symb
11. 800 621 3739 www gyrusacmi com EC REP Gyrus Medical Ltd Fortran Road St Mellons Cardiff CF3 OLT United Kingdom 0344 PlasmaKinetic PK Plasma Cise PK Plasma Cut and PK SEAL are trademarks or registered trademarks of Gyrus ACMI Inc and or its affiliated entities in the U S and or other countries Rx only CAUTION Federal USA law restricts this device to sale by or on the order of a physician Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 15 1 SI NOLLIHS s lt pd gt gt gt Z lt DN e p lt Q Z N SECTION 16 News THE UL APPROVAL APPLIES TO GYRUS ACMI PRODUCTS ONLY SSIS O PSSI wi MEDICAL ELECTRICAL EQUIPMENT CLASSIFIED BY UNDERWRITERS LABORATORIES INC WITH RESPECT TO ELECTRIC SHOCK FIRE MECHANICAL HAZARDS AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 AND CAN CSA C22 2 NUMBER 601 1 E1 76665 CAUTION USE ONLY THE POWER CORD PROVIDED BY MISE EN GARDE UTILISER UNIQUEMENT LE CORDON YOUR PRODUCT SUPPLIER D ALIMENTATION FOURNI PAR VOTRE DO NOT USE ANY OTHER POWER SUPPLY CORD FOURNISSEUR NE PAS UTILISER D AUTRE TYPE DE CORDON D ALIMENTATION CAUTION THE POWER SUPPLY CORD PROVIDED IS INTENDED MISE EN GARDE LE CORDON D ALIMENTATION EST CONCU FOR NORTH AMERICAN 110V USE THIS POWER CORD POUR UNE UTILISATION EN AMERIQUE IS UL LISTED TYPE SJT RATED 120
12. 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 PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Overview Part Number 144020 LB O lt LL A lt rm O mn la rm Q lt A C gt 2 U C U LL A U Cc r rm Q LL lt LL A gt lt O A TABLE OF CONTENTS SECTION PART PAGE 1 INTRODUCTION 1A Overview of the Superpulse System 1B Comparison with Conventional Surgery 1C Indications for Use 1D Contraindications for Use 1E System Description mk ee Ce Ce Cn N N N 2 PATIENT AND OPERATING ROOM SAFETY 2A General 2 1 2B Servicing Equipment Disposal 2 2 2C Fire Explosion 2 3 2D Before Surgery 2 3 2E During Surgery 2 4 2F After Surgery 2 6 2G EMC Classification 2 6 3 INSTALLATION 3A Responsibility of the Manufacturer 3 1 3B SuperPulse Generator Power Requirements 3 1 3C Grounding of the SuperPulse Generator 3 1 gt 3D Routine Maintenance of the SuperPulse Generator 3 1 4 GENERAL INFORMATION 4A SuperPulse Generator Indicators and Displays 4 1 es 4B Output Mode Selection Power Controls 4 3 4C Olympus TURis Mode 4 5 4D SuperPulse Generator Indicators Set up and Malfunction Displays 4 7 4E Changing the Display Language
13. V m including cables than the recommended IEC 61000 4 3 80 MHz to 2 5 GHz separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance 1 17 VP 1 17 VP 80 MHz to 800 MHz 2 33 VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m 7 BANCO ROI te Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following o NOTE 1 At80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elctromagnetic site survey should be considered If the measured field strength in the location in which the SuperPulse Generator is used exceeds the applicable RF compliance level above the S
14. 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 The SuperPulse mode of operation enables very rapid formation of the plasma enabling easier and more rapid resection of tissue 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 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 Axipolar 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
15. power 320 watts into 150 ohms SP1 Maximum power 325 watts into 200 ohms SP2 Maximum power 333 watts into 200 ohms SP3 Maximum power 128 watts into 70 ohms DES Max Voltage PK1 SP1 360 Volts Peak PK2 SP2 TS1 TS2 434 Volts Peak PK3 SP3 480 Volts Peak T1 434 Volts 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 TPS 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 SuperPulse Generator Each accessory will self impose an upper set power limit for the SuperPulse Generator Power Linearity 230V 50 Hz a c 250 4 200 gt D A 100 50 4 0 4 0 50 100 150 200 250 Measured Power Linearity PK3 into 150 Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Page 10 2 Part Number 144020 LB SECTION 10 PERFORMANCE SPECIFICATIONS Half Power Coagulate Load Curves PN 70 e 60 50 Des 40 VPI Z 30 VP2 20 VP3 10 0 _ i 0 500 1000 1500 Load Resistance Half Power Cut Load Curves 120 4 100 PKI 80 e PK2 60 PK3 i T1 40 T2 20 0 500 1000 1500 Load Resistance Half P
16. 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 e e e lt pd a gt Z es Z N gt 5 es lt e a es e A DN Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 13 2 SECTION 14 EMC TABLES Guidance and Manufacturer s Declaration Electromagnetic Emissions The SuperPulse Generator is intended for use in the electromagnetic environment specified below The customer or the user of the SuperPulse Generator should assure that it is used in such an environment BE pu asss Group 1 The SuperPulse Generator uses RF energy only for CISPR11 its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment wa The SuperPulse Generator is suitable for use in all RF E lass A l ARR establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic Harmonic Emissions Class A Po Ranma IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 VI NOLLOHS Z O gt s DM Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Page tad Part Number 144020 LB 9 VI NOLLOHS Z O gt
17. shown that electrosurgical smoke generated during electrosurgical procedures can be potentially harmful to surgical personnel 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 Do not insert fingers or objects other than the correct cables into the socket activate the footswitch with an instrument attached Only 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 sodium chloride solution For convenience this will be referred to within the remainder of this manual as normal saline Servicing Equipment Disposal CAUTION CAUTION 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 the recommended periodic equipment safety checks in Section 13 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
18. two instruments to be fitted simultaneously via the two 5 way connectors 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 gt es Z es e gt k Z 5 e lt gt Z 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 USER MANUAL Part Number 144020 LB Page 4 6 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
19. 00 700 800 900 1000 Load Resistance R Vapor Pulse Waveforms VP3 VP2 8 VP1 Pulsed coagulation outputs with a limited maximum output voltages During the off periods no RF output occurs Repetition rates for each VP waveform will be constant but may vary with different instrument types Voltage limits VP3 120Vrms VP2 100Vrms VP1 73Vrms The output power is defined as follows PeakPower x OnTime AveragePower CycleTime 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 a gt es e e lt gt Z e N a gt es e pd e gt a Z N Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 10 5 SECTION 10 PERFORMANCE SPECIFICATIONS SuperPulse waveforms SP1 SP2 SP3 Pulsed vaporization outputs with limited 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 PeakPower x OnTime AveragePower 01 NOILOAS CycleTime 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 a gt es e e gt Z e N a gt es O e gt Z N
20. 4 10 A 4F Enabling Additional Instruments via a PIN code 4 11 A 5 BEFORE SURGERY 5A Power up the SuperPulse Generator 5 1 Z 5B Select the Appropriate PK SP Instrument s for the Procedure 5 2 5C Steam Sierilise the PK Connector Cable PlasmaKinetic Resectoscope or appropriate urological endoscope 5 4 Z 5D Connect the PK Connector Cable 5 4 _ 5E Prepare the PlasmaKinetic Resectoscope or urological endoscope 5 4 VN 5F Attach PlasmakKinetic Instrument to the PK Connector Cable 5 8 6 DURING SURGERY 6A Accessories 6 1 6B Recommendations during Surgery 6 1 7 TECHNIQUES TO OPTIMIZE PERFORMANCE 7 1 8 AFTER SURGERY 8A Following Surgery Involving PlasmaKinetic Resectoscope Instruments 8 1 8B Following Surgery Involving Plasmakinetic Cystoscope Instruments 8 1 8C Following all Surgery Involving the Superpulse Endourology System 8 2 9 OPERATING ROOM TROUBLESHOOTING 9 1 10 PERFORMANCE SPECIFICATIONS 11 ERROR AND FAULT CODES 11 1 12 EXPLANATION OF SYMBOLS 13 PERIODIC EQUIPMENT SAFETY CHECKS 13 1 14 EMC TABLES 14 1 15 LIMITED WARRANTY 15 1 Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB SECTION 1 INTRODUCTION Gyrus Medical Ltd Gyrus Medical Inc and Gyrus ACMI Inc are referred to as Gyrus ACM 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 1B
21. 5 sec or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SuperPulse Generator continued power requires during operation mains interruptions it is recommended that the SuperPulse Generator be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or environment hospital Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology Part Number 144020 LB USER MANUAL Page 14 2 SECTION 14 EMC TABLES x Guidance and Manufacturer s Declaration Electromagnetic Immunity x The SuperPulse Generator is intended for use in the electromagnetic environment specified below The customer or the user of the SuperPulse Generator should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Level Level Guidance Conducted RE a iia Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the SuperPulse Generator Badisted BF ains 3
22. AL FAILURE INTERNAL FAILURE INTERNAL FAILURE Not used INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE Not used INTERNAL FAILURE Not used INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE Not used INTERNAL FAILURE RAM INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE ERROR AND FAULT CODE TYPE DESCRIPTION Continuous test timing PWM signal shorted high PWM signal shorted low SYNC signal shorted high SYNC signal shorted low ENERGY signal stuck high F IOUT signal stuck high comparator in U F CUT COAG signal stuck high F CUT COAG signal stuck low CLAMP signal error DAC output F PEAKSET signal error DAC output F PEAK signal error stuck high comparator in RF_DET signal error stuck low F OVERDOSE signal error permanently ON F ENERGY signal error stuck low S Temperature monitor inoperative Reserved for audio fault detection CURRLIM signal error DAC output F VOLTLIM signal error comparator input F BUSVOLTS signal error analogue input F Incorrect PK RF board installed RF relay 1 socket not operating RF relay 2 poles not operating SP board RF_ACTIVE stuck on SP board Output r
23. Active Or Working Element Passive Telescope Inner sheath Outer sheath Or Outer sheath rotatable Standard Obturator Olympus Light Guide Adapter Visual Obturator Ellik Evacuator Adapter Continuous Flow Sheath Resectoscope Sheath 24 Fr Intermittent Sheath NOLLIHS Fig 1 1 Example System 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 Z zi Q gt p Q Z 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 t
24. ING SURGERY This section describes how to use the Gyrus ACMI SuperPulse Endourology System during surgery 6A 6B Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Accessories IMPORTANT Use only approved PlasmaKinetic or Olympus TURis Instruments Connector Cables and Resectoscopes Instruments connector cables and resectoscopes other than those approved accessories with the Gyrus ACMI SuperPulse Endourology System must not be used The Gyrus ACMI SuperPulse Generator and Endourology surgical accessory has been designed as a system with accessory features specifically designed to maximise safety and effectiveness Unless the SuperPulse Generator is able to interrogate the correct identification code contained within the instrument to establish the optimum default settings all output functions will be disabled Recommendations During Surgery Refer to the cautions and warnings at the front of this manual Unless circumstances dictate otherwise use the instrument default settings to enhance patient and user safety Remove any gross tissue build up from instruments to maximise surgical effect Avoid any unnecessary and prolonged activation to prevent overheating When debulking or vaporising tissue use a progressive surface shaving technique rather than burying the instrument in tissue in order to reduce debris and control the effect to the area of treatment Th
25. L FAILURE Error code 200 Ref 25 Fig 4 11 Screen for critical error display gt es Z es e gt Z e lt gt Z 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 USER MANUAL Part Number 144020 LB Page 4 9 SECTION 4 GENERAL INFORMATION 4E CHANGING THE DISPLAY LANGUAGE From the SuperPulse generator idle state with the VFD screen showing the Connect PK Cable or K Way Cable Attached Insert Device message press and hold for 3 seconds O 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 f English b NOILILOAS Fig 4 12 Use the right hand arrow buttons to change the language as required Press and hold the Mode Menu button down to retu
26. ORTANT SuperPulse SP mode can only be used with Gyrus ACMI SuperPulse compatible instruments SuperSect SuperLoop and SuperV instruments 4B Output Mode Selection and Power Controls 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 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 SP3 Difficult high flow conditions and or High impedance Cut SP2 Moderate flow conditions SP 1 Low flow conditions T Voltage increasing PlasmakKinetic PK3 High impedance tissue fatty vascular tissue Cut PK2 Medium impedance tissue PK1 Low impedance tissue thin tissue T Voltage increasing ThermoKinetic Cut T T2 High impedance tissue fatty vascular tissue T1 Low impedance tissue thin tissue T Voltage increasing TS TS1 Moderate tissue vascularity TS2 Higher tissue vascular
27. P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Z O gt DM Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 14 4 SECTION 15 LIMITED WARRANTY The manufacturer warrants the products listed below to be free from defects in material and workmanship under normal use and service for the period s set forth below The manufacturer s obligation under this warranty is limited to the repair or replacement at its sole option of any product or part thereof which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser and which examination discloses to the manufacturer s satisfaction that the product is defective This warranty does not apply to any product or part thereof which has been repaired or altered outside the manufacturer s factory in a way so as in the manufacturer s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for the components of the PlasmaKinetic SuperPulse Gene
28. Page 8 1 SECTION 8 AFTER SURGERY 8C Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Following all Surgery involving the Gyrus ACMI SuperPulse Endourology System If using the reusable cable 8900 3905 clean and sterilise the PK Connector Cable Prepare the PK connector cable for steam sterilisation according to the following cleaning procedure a Remove all gross matter blood mucus tissue etc by wiping the reusable Connector Cable with a cloth or gauze pad and a mild cleaning solution or detergent capable of removing organic deposits IMPORTANT To avoid damage to the cable and connectors do not immerse in reprocessing solutions or use abrasive cleaning agents b Rinse thoroughly in running water c Remove residual cleaning agents with a water damp cloth d Dry the device thoroughly before sterilising Sterilise the connector cable according to the sterilisation procedure described in the Connector Cable Instructions For Use IMPORTANT The connector cable supplied as part of the Gyrus ACMI SuperPulse Endourology System is intended for 20 re use cycles only WARNING Do not attempt to re use PlasmaKineticr Instruments Heat or chemical sterilisation may render the instrument mechanically or electrically unsafe ARNING Exceeding the recommended number of uses may result in electrical or mechanical failure during use or difficulty when attaching or detaching the instrument
29. TATUS failure POST check F Mains input failure POST check F OVERDOSE failure POST check F PWM low failure POST check F ID CAL circuit failure POST check F BUSLIM failure POST check F CURRLIM failure POST check VOLTLIM failure POST check F SPRF_ACTIVE failure POST check F VCC ANA DIV 2 failure POST check F 12V failure POST check OV failure POST check RF VOLTAGE POST check RF_CURRENT failure POST check ANALOGUE_REF failure VCC_ANA_DIV_2 failure F 12V failure F 0V failure F RF_DET stuck high failure F PSU STATUS failure F Mains input failure BUSLIM failure CURRLIM SET failure SP PSU OR PK RELAY failure Electrode ID Failure EEEE 7 Internal overheating F Excess RF input voltage error RFBUS gt set Tl Tl TI Excessive RF output F Impedance V feedback circuit error SP board not supplying RF energy Page 11 3 LL NOLDOUS e e e gt Z J P gt lt O es N SECTION 11 ERROR AND FAULT CODES ERROR KOR TEXT STRING TYPE DESCRIPTION CODE INVALID ELECTRODE SOFT Unsupported electrode type SP OUTPUT ERROR Bl Persistent over voltage or current error FOOTPEDAL STUCK Footswitch BLUE pedal stuck FOOTPEDAL STUCK Footswitch YELLOW pedal stuck FOOTPEDAL STUCK Black Mode Footswitch stuck 400 INTERNAL FAILURE Electrode identification circuit fault BUTTON STUCK R Front panel CUT left UP button stuck BUTTON STUCK
30. TIMIZE PERFORMANCE Whether using a PK resectoscope or cystoscope instrument tissue removal rate using the PK SP output modes is optimised by keeping the instrument in continuous motion during firm application against the tissue surface It is normal for some superficial browning and carbonisation to occur during resection At the conclusion of the procedure this can be simply removed by softly brushing the instrument over the surface To desiccate or coagulate a bleeding site the instrument tip should be applied to the site using firm pressure Once positioned activate the desiccate output until visible blanching is observed around the application site L NOILOAS Transurethral prostatectomy can be performed using the familiar techniques of monopolar electrosurgery with the instrument stroke removing a similar volume of tissue by vaporisation as that achieved using a monopolar loop To optimise the advantages of the Gyrus ACMI PlasmaKinetic System and avoid creation of loose tissue pieces the resection surface should be kept as even as possible Undercutting of resection margins varying the application pressure during activation and burying of the instrument beyond half its circumference can result in an irregular surface and the production of loose tissue pieces Irregularities or tissue tags produced during resection are best removed using a firm side to side surface application rather then the conventional proximal to distal cutting ac
31. V AT 10A MINIMUM DU NORD SOUS UNE TENSION DE 110V CE FOR OPERATION AT OTHER MAINS SUPPLY VOLTAGES CORDON D ALIMENTATION EST DE TYPE UL CONSULT YOUR LOCAL PRODUCT REPRESENTATIVE SJT ALIMENTATION 120V ET 10A MINIMUM FOR ADVICE OR THE PROVISION OF A REPLACEMENT CONTACTER VOTRE REPRESENTANT LOCAL POWER CORD POUR UNE UTILISATION A UN AUTRE VOLAGE WARNING RISK OF FIRE ATTENTION RISQUE D INCENDIE REPLACE FUSE AS MARKED REMPLACER LE FUSIBLE COMME INDIQUE Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB
32. 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 Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 2 6 SECTION 2 PATIENT AND OPERATING ROOM SAFETY M 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 e 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 Cc NOLLI HS Keep the accessory cables away from cables from other electrical eguipment E
33. ation site This particularly applies when dividing strictures which prevent good irrigation flow during activation es e a Z lt es DN gr N G e e lt gt Z e Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 7 1 8 NOLLIHS gt 5 es e N e QO es e lt SECTION 8 AFTER SURGERY After surgery the following steps should be performed 8A 8B Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Following Surgery involving PlasmaKinetic Resectoscope Instruments a Detach the instrument from the PK connector cable by grasping the two halves of the connector by the moulded finger grips and pulling apart ena oi Always detach by grasping the connector grips and not the cable s Failure to do SO may result in product damage Remove the instrument from the working element Dispose of the SINGLE USE instrument s and single use connecting cables according to your facility s policy on the destruction of surgical waste Gyrus ACMI provides both reusable and disposable connecting cables check which is used by your facility Disconnect the PK connector cable from the SuperPulse Generator by grasping the plug and pulling gently from its socket on the front of the SuperPulse Generator The resectoscope components including the telesco
34. be inadvertently caused by inverting the footswitch or standing on a pedal as the generator is switched on CHECK RRI GANT CABLE gt es Z es e gt a Z e lt gt Z 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 USER MANUAL Part Number 144020 LB Page 4 8 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 KOO 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 Fault code 400 Ref VCO ROC k Fig 4 10 Screen for recoverable fault display Critical Non recoverable Errors 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 INTERNA
35. copes with 5 Fr or larger working channels The tip design of these instruments falls into 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 Active Electrode Return Efectrode p Pi i lt w Ceramic Insulator _ Active Tip Y Connector Plug LI Shaft Fig 5 3 Fig 5 3a NOTE Specific information regarding the instrument classification codes are provided on the instrument package labelling Steam Sterilise the PK Connector Cable PlasmaKinetic Resectoscope or appropriate urological endoscope Please refer to the PK Connector Cable Instructions for Use and PlasmaKinetic Resectoscope User Manual for their respective recommended sterilisation procedures Refer to manufacturer s instructions for urological endoscope sterilisation procedure Connect the PK Connector Cable or TURis Connector Cable Introduce the sterile connector cable to the sterile instrument table or trolley according to the sterile handling practices at your facility The cable and connectors should be inspected for any processing damage IMPORTANT If any of the connector pins are bent or if the cable shows any signs of crush damage cracking or distortion it must be discarded Page 5 3 SECTION 5 BEFORE SURGERY The SuperPulse Generator end of the connector cable should then be passed to a n
36. cord Use only hospital grade power cords IMPORTANT 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 Page 3 1 SECTION 4 GENERAL INFORMATION 4A Gyrus ACMI SuperPulse Generator Indicators and Displays Red warning lamp Gyrus Medical Ltd Superpulse System c 2003 Version V2 00 Active instrument LZ Standby Standby On indi Mode On Button area indicator L Menu Connector Cable Plasmakinetic Button sockets SuperPulse and Vapor Pulse and Des ThermoKinetic Up Down Up Down Fig 4 1 Keypad Standby On Up Down Arrows and Mode Menu Button Standby On 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 Following an error condition the generator may be reset by pressing the Standby On button twice Up Down Arrows lt A Depressing the up or down arrow when parameter cha
37. e active and return elements of the instrument tip must be fully immersed in saline irrigant before activation 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 active tip of the PlasmakKinetic Instrument If not using continuous flow irrigation it is important that the bladder Is drained as soon as the irrigant flow rate is seen to diminish CAUTION Do not attempt to crush or remove prostatic calculi by trapping between the instrument tip and the resectoscope beak This practice may damage the tip of the instrument or the resectoscope working element Use of Default Power Settings The power settings used for the intended procedures vary considerably both with the surgeons technique and the configuration of the active instrument The PlasmaKinetic instruments are unique to the type of procedure being undertaken and some experience may be required before optimal power settings to suit the particular surgical technique are determined The Gyrus ACMI SuperPulse Endourology System has an output power capability more equivalent to a monopolar electrosurgical unit than a conventional bipolar el
38. e desired surgical effect Z Rao 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 CAUTION CAUTION CAUTION 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 Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase or decrease in output power Use caution when overriding the default power settings 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 WARNING 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 Do not wrap accessory cords around metal objects This may induce currents that could lead to injury to the patient or surgical personnel Fire Hazard Do not place active accessories near or in contact with flammable materials such as gauze or surgical drapes Electrosur
39. eakage during use 5E Attaching PlasmaKinetic Instrument via the PK Connector Cable Connect the PK instrument to the PK Connector Cable by aligning the two connector halves using the moulded orientation marks and then pushing together Once connection is made the Insert Device symbol Fig 4 2 flashing on the SuperPulse Generator display will change to the default settings appropriate to the instrument classification code For safety and convenience PK instruments automatically pre set the SuperPulse Generator to default output settings and restrict output levels to preserve instrument integrity 5F Attaching TURis Instruments to the Generator Assemble the Olympus Resectoscope according to the instructions supplied Connect both connectors on the supplied cable to the Resectoscope Insert the selected Olympus TURis Electrode into the Resectoscope Then attach the cable to the right hand socket of the Gyrus ACMI SuperPulse Generator marked PK SP The generator screen will change to show default settings Modify the generator settings as indicated and as necessary to achieve the desired tissue affect es e N lt e QO es e lt Connect TURis to the right hand SuperPulse socket only as shown in Fig 5 4 jy c ff lt Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 5 4 9 NOLLOUS 2 Z p N re p s lt SECTION 6 DUR
40. ectrosurgical unit Until the surgeon becomes familiar with the characteristics of the system caution should be used in increasing power output levels above the instrument default settings It should be noted that the SuperPulse Generator incorporates a PK mode output power boost feature when connected to a PK Plasma V Resectoscope Instrument This boost functions by automatically Page 6 1 SECTION 6 DURING SURGERY increasing the selected power output setting of the SuperPulse Generator by 25Yo during the first 400 milliseconds of cut activation up to a maximum output of 200W Use of Default Mode Settings Similar to power settings the mode selection for procedures vary considerably both with the surgeon s technique and the configuration of the active instrument The PlasmaKinetic instruments are unique to the type of procedure being undertaken and may require some experience before the effects of the different mode settings become apparent PlasmaKinetic PK SuperPulse SP Modes The three PK SP mode levels adjust the tissue effect of the output PK3 SP3 gt PK2 SP2 gt PK1 SP1 the more aggressive tissue vaporisation produced by a PK3 SP3 selection More aggressive tissue vaporisation will produce more vapour bubble formation CAUTION The formation of vapour bubbles may obscure visualisation during activation particularly when operating in a very confined space or during reduced irrigation flow Use caution when adjusting
41. elay non functional SP board BUS relay non functional CPU POST failure RAM test failure POST check Crystal failure POST check F Analogue reference failure POST check F CLAMP_SET failure POST check F BOOST_SET failure POST check F CURRLIM_SET failure POST check F PEAK SET failure POST check Page 11 2 SECTION 11 ERROR CODE 300 300 300 Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB TEXT STRING INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE THERMAL SHUTDOWN INTERNAL FAILURE Not used OUTPUT SHORTED INTERNAL ERROR INTERNAL ERROR Reserved ERROR AND FAULT CODE TYPE DESCRIPTION COAG CUT failure POST check PK CUT COAG failure POST check PK_SKT_SET failure POST check F SUPERPULSE_RELAY failure POST check NO RF failure POST check RFBUS VOLTS failure POST check R POST AUDIO Set up POST check F PSU S
42. ent Unless the instrument has the same identification code any adjustments to the SuperPulse Generator settings made when using the previous instrument will be overridden If using Olympus TURis instruments select the required settings for the connected instrument to achieve the desired tissue effect Changing Accessories Between Procedures Section 8 describes the disconnection of the PK connector cable and instrument Once the PK connector cable is disconnected the SuperPulse Generator will automatically enter the idle state with the display showing 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 The SuperPulse Generator can be left in the idle state between procedures 2 Z e N re p s lt CAUTION If the SuperPulse Generator is maintained in the idle state between procedures and the same instrument configuration is employed for the next procedure then any adjustments made to the output settings during the previous procedure will be remembered and will supersede the default settings Switching the power off will clear all output adjustments and on subsequent use the output will assume the default settings for the selected instrument Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 6 3 SECTION 7 TECHIGUES TO OP
43. evant curve The diathermy tester must be rated to read Watts at the appropriate frequency and have non reactive loads All connections should be insulated wherever possible to prevent electric shock risk and short circuiting The generator sockets receive two and four millimetre diameter plugs To measure desiccate outputs up to 150 Watts C1 shall be 4 7 nF 1 A 150 ohm load should be used To measure PK outputs up to 200W C1 shall be 68nF 10 A 150 ohm load should be used lt is difficult to measure the output of the SuperPulse and TS waveforms accurately whilst pulsing without the use of specialized equipment It is however possible to measure the output in continuous wave mode by attaching a 560ohm load resistor The value of C1 should be 4 7nF The power should be set to 200W SP2 on the generator and the cut pedal pressed to produce an output G es e lt O es p G lt es Z p N gt es lt e a es e A N Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 13 1 SECTION 13 PERIODIC EQUIPMENT SAFETY CHECKS eal mi E D Front view Proprietary of LH Surgical Z socket U Diathermy Nee fester Ss Co Proprietary o E S Surgical A TAN Dia therm y a Fr o S N TesTer a i eh al MAA J socke Li Details of these tests
44. gery 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 2D Before Surgery Active Accessories Electric Shock Hazard Do not connect wet accessories to the SuperPulse Generator Electric Shock Hazard Ensure that all accessories are correctly connected and that no metal is exposed il Do not attempt to re use instruments labelled for Single Use Only Heat or chemical Sterilization may render the instrument mechanically or electrically unsafe esse Head 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 USER MANUAL Part Number 144020 LB Page 2 3 Cc NOLLI HS G gt p es Z gt Z J E es e gt Z gt e lt N gt lt c NOLLI HS a gt gt pd es Z gt Z J a gt lt e gt p Z G e Z N gt es lt CAUTION CAUTION PATIENT AND OPERATING ROOM SAFETY Use only approved accessories supplied for use with this product Product damage or accessory failure may otherwise res
45. gical accessories which are activated or hot from use can cause a fire Endoscopic Procedures WARNING Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB 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 Page 2 5 c NOILOAS G gt p es Z gt Z J G es e gt Z G e Q lt N gt es lt c NOLLI HS G gt es Z gt Z J a gt lt e gt Z G e gt lt N gt es lt SECTION 2 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
46. gy USER MANUAL Part Number 144020 LB Page 5 1 SECTION 5 BEFORE SURGERY 5B Select the Appropriate PK SP Instrument s for the Procedure Instrument Default Settings For your convenience and to improve safety during use all Gyrus ACMI instruments have an internal identification code which is interrogated by the SuperPulse Generator when the instrument is attached Default settings and power set adjustment limits are then set appropriately for that particular instrument Types of Gyrus ACMI PK Instrument There are two fundamental categories of PlasmaKinetic instruments those for use with Resectoscopes and those for use with urology endoscopes e g Cystoscopes For information on the assembly of Resectoscope Endoscope Instruments also refer to the supplied Instruction for Use MN e p Q Z Vi 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 PlasmaKinetic Resectoscope The PlasmaKinetic Resectoscope is available with either active or passive working elements PK SuperSect Loop Resectoscope instruments figure 5 1 SuperLoop instrument and figure 5 2 instrument tip are designed to pr
47. hird mode is also available the ThermoKinetic 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 USER MANUAL Part Number 144020 LB Page 1 3 LT NOLDOUS Z a gt p Q Z SECTION 1 INTRODUCTION Fig 1 2 Example of Gyrus ACMI Resectoscopic 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 Ur I N C pas 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 USER MANUAL Part Number 144020 LB Page 1 4 SECTION 2 PATIENT AND OPERATING ROOM SAFETY 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 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 technigue and properly trained
48. ill bleep to acknowledge the PIN entry If the code is entered incorrectly then the following display will be shown Invalid Pin code Fig 4 15 The PIN entry sequence must then be repeated press any arrow button to restart the PIN entry sequence Note If the PIN 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 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 previously Insert the instrument if the following display is shown on the VFD Enter Pin Code To enable Instrument Fig 4 16 then the PIN code must be entered as detailed previously in section 4F however no timeout will occur when the instrument is connected Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 12 SECTION 4 GENERAL INFORMATION e 1 AC Power Connector 6 RS232 Connector _ Connector for the AC line power cable Used by qualified Gyrus ACMI technical p personnel only Do not connect any 2 Equipotential Connector device to this port Z The connection for the Potential Equalization Conductor terminates at this point 7 Fuse Label Provides information on correct fuse to 3 Power Switch u
49. isk of being accidentally dislodged during the course of operating theatre 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 connect the other end of the cord directly to an AC power point Avoid the use of extension cords or multiple plug adapters Wherever possible avoid trailing leads and neatly store excess power cord Connect the Footswitch Connect the dual pedal footswitch to the receptacle at the rear of the SuperPulse Generator by orientating the lug on the plug with the groove in the receptacle and pushing the plug into place Secure the plug by screwing down the locking ring in a clockwise direction Switch the SuperPulse Generator On Apply mains power to the generator by operating the On Off rocker switch located on the rear panel Verify the completion of the system initialisation sequence of tests by observing the increasing numeral display es P e es N e QO es e lt The Attach PK Cable message confirms that the system is in idle state and is now ready for use with any connected instrument Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourolo
50. ity T Hemostasis decreasing Gyrus ACMI Plasmakinetic SuperPulse Generator Endourology USER MANUAL Page 4 3 Part Number 144020 LB vy NOILILOAS gt es Z es e gt Z e lt gt Z b NOILILOAS gt lt Z es e gt w Z e lt gt Z SECTION 4 Coagulation GENERAL INFORMATION DES General purpose Non tissue specific desiccation VP3 High impedance tissue fatty vascular tissue VP2 Medium impedance tissue VP1 Low impedance tissue thin tissue T Voltage increasing 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 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 The PK output is not available for some PK instruments The lower left hand portion of the display remains blank in this case Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 4 SECTION 4 GENERAL INFORMATION 4C Mode Selection using Gyrus ACMI PKISP 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 impeda
51. lectrical currents may be induced in the other eguipment causing unintended effects e 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 e 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 e 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 g gt Z gt Z J G es e gt p Z gt e lt N gt es lt Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 2 7 CO P G kt Z MN gt ss gt p Q Z 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 pr
52. 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 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 e A suitable Gyrus ACMI Urology Electrode e g PK Plasma Sect PK SuperSect Superloop and PK Button see Fig 1 2 e When used with a suitable urological endoscope e g Cystoscope e APK Plasma Cise or PK Plasma Cut instrument see Fig 1 3 When used with an approved Resectoscope e Olympus Electrodes Compatible with the Gyrus ACMI SuperPulse System Supplied with connector cable Page 1 2 SECTION 1 INTRODUCTION Typical Resectoscope Components Working Element
53. nce 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 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 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 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 re
54. nerator displays a malfunction The permissible range of power adjustment will be limited by the instrument classification code Adjustment of output modes PK1 SP1 PK2 SP2 PK3 SP3 T1 T2 TS1 and TS2 can be changed at any time other than while activated or while the SuperPulse Generator displays a malfunction Output Warning indication during Surgery 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 9 NOLLOUS Changing Instruments During Surgery An instrument can be detached from the connector cable and removed from the endoscope simply by reversing the instructions for installing the PlasmaKinetic Instrument Once the instrument is disconnected the SuperPulse Generator will automatically enter the idle state with the display showing 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 instrum
55. nge is permitted increases or decreases the parameter step wise Holding the button down will increase or decrease the value in preset steps Mode Menu OQ This button provides access into the waveform selection and setup menus gt es Z es e gt Z e lt gt Z Repeated short presses will give access to the frequently used functions listed below e Cut waveform selection PK SP e Coagulation waveform selection VP DES e Volume Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 1 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 e Display intensity e Key click on off e Select language e Enter PIN Code NOTE If there is no user activity for a short period the generator will exit the menu and return to Idle Ready state When a PK connector cable is attached the symbol below appears on the display 3 Way Cable Attached Insert Device b NOILILOHAS AA St O Fig 4 2 Screen for 3 Way PK cable installed on the selected socket Output Displays for SP PK Instruments 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 indicate
56. ntended WARNING WARNING ENN Do not use electrosurgical equipment unless properly trained in its use in the specific ENN 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 ENNS 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 USER MANUAL Part Number 144020 LB Page 2 1 t NOILOAS G gt es Z gt Z J G e gt Z G a
57. obsolete electronic equipment Dispose of any system accessories according to normal institution practice relating to disposal of biologically contaminated items USER MANUAL Page 2 2 SECTION 2 PATIENT AND OPERATING ROOM SAFETY 2C Fire Explosion NAN Explosion Hazard Do not use in the presence of flammable anaesthetics ONIN 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 ARNING Fire Explosion Hazard Verify that all oxygen circuit connections are leak free before and during use of electrosurgery When using electrosur
58. ols are still legible oe Retract the fuse drawer of the mains inlet connector and verify that both fuses are intact and match the rated current and breaking characteristics as per the back panel label Verify that the resistance between the earth terminal of the mains inlet connector and the Generator enclosure is within the limits defined in EN 60601 1 or the corresponding national standard as applicable Switch on the Generator ensuring that the initial internal self test is completed normally as reported on the front panel display Check that the audio alarm front panel warning indicator and vacuum fluorescent display are 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 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 as defined within EN 60601 1 or a corresponding national standard If there is any doubt about the PK RF output power of the generator it must be returned to the supplier for testing A power output assessment may be performed on the bipolar output by using the connections described below The output may be compared to the load curves specified in the previous sections The output should be within 20 of the rel
59. on sterile operative for connection to the SuperPulse Generator Ensure that sufficient length of cable is retained for connection to the instrument that sufficient slack is provided so that operation is not impeded and that sufficient slack is also allowed for tethering to the surgical drapes Urological endoscope The urological endoscope should be prepared for use according to the manufacturer s instructions NOTE The PlasmaKinetic Cystoscope instrument would normally be attached to the connector cable prior to its introduction into the working channel See section 5F for attachment instructions Introducing the PlasmaKinetic Cystoscope Instrument through the working channel With the endoscope having been introduced through the urethra pass the instrument through the working channel ensuring that the working channel tap is in the fully open position prior to introduction Once the instrument is inserted tether excess cable flex to the sterile drapes to prevent dragging during manipulation S NOILOAS Avoid the use of excessive force when inserting instruments through a working channel Angled working channels often 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 br
60. operating room staff It is important that the operating instructions supplied with this or any electrosurgical eguipment 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 General WENNS Hazardous Electrical Output This equipment is for use only by qualified personnel Use only approved accessories WENN 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 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 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 procedure i
61. ovide advanced electrosurgical effects during endoscopic urological surgery under normal saline irrigation 3A 3B 3C 3D Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Responsibility of the Manufacturer The manufacturer is responsible for safety reliability and performance of the equipment only if Installation procedures in this manual are followed Assembly operations extensions re adjustments modifications or repairs are carried out by persons 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 SuperPulse Generator Power Reguirements 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 Grounding of the SuperPulse Generator To ensure user safety the SuperPulse Generator must be properly grounded through the inlet plug and power
62. ovide rapid tissue resection vaporization or desiccation Unlike monopolar vaporisation techniques the Gyrus ACMI system will vaporise tissue effectively irrespective of the number of times the device has been passed over the tissue surface This is due to the fact that the current flows only through the tissue being vaporised Fig 5 1 es P gt f e Fig 5 2 2 gt Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Page 5 2 Part Number 144020 LB S O RRO HS es e es DN e QO es e lt 5C 5D Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB SECTION 5 BEFORE SURGERY Types of Olympus PK TURIs Instruments The Olympus PK TURis range of instruments is compatible with the SuperPulse Generator and should be connected to the right hand SuperPulse socket Assemble the Olympus Resectoscope and Instruments before inserting the connector into the SuperPulse Generator socket IMPORTANT Ensure saline is used as the irrigant PlasmaKinetic Cystoscope Instruments The PlasmakKinetic Cystoscope Instruments are designed to fit through endoscopes with a working channel of 5Fr or larger with the appropriate septum cap The intended use of the PlasmaKinetic Cystoscope instruments is to perform vaporisation and desiccation of soft tissue pathologies using endoscopes such as cystoscopes or urethros
63. ow er SP Load Curve 800 Load Resistance a gt es e e lt gt Z e N a gt es e pd e gt a Z N Half Power Load Curves Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 10 3 SECTION 10 PERFORMANCE SPECIFICATIONS Full Power SP Load Curve DN e p Q Z pd 800 Load Resistance Full Power Coagulate Load Curves 140 120 4 100 Des s 80 vp M vP2 VvP3 a7 40 5 zo lt 3 0 500 1000 1500 va Load Resistance gt Full Power Cut Load Curves A 250 4 v 200 PK1 as PK2 150 PK3 e 100 T1 T2 50 lt 0 500 1000 1500 Load Resistance Z Full Power Load Curves YN Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Page 10 4 Part Number 144020 LB SECTION 10 PERFORMANCE SPECIFICATIONS Power TURis Cut Mode Half Power 100W 140 120 100 0L NOILOAS a 0 100 200 300 400 500 600 700 800 900 1000 Load Resistance R Power TURis Cut Mode Half Power 100W 140 120 pres 100 80 60 4 40 20 0 100 200 300 400 500 6
64. pe are suitable for manual or machine washing If automated instrument washing systems are to be used and the components are 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 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 stop taps All taps should be open or disassembled during both cleaning and sterilisation to allow the free flow of cleansing sterilising agents After cleaning the components must be rinsed with water to remove residual cleaning agent and then dried thoroughly using compressed air if necessary Taps should be disassembled and re greased prior to sterilisation Sterilise the Resectoscope according to the recommended procedure described in the Resectoscope User Manual Following Surgery involving PlasmaKinetic Cystoscope Instruments Remove the instrument from the urological endoscope Clean and sterilise the urological endoscope according to the manufacturer s instructions Disassemble the instrument and connector cable as described for the PlasmakKinetic Resectoscope Instruments above Dispose of the SINGLE USE instrument s according to your facility s policy on disposal of biologically contaminated waste
65. put 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 1D TE Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB 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 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
66. quired 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 USER MANUAL Part Number 144020 LB Page 4 5 b NOILOHAS gt lt Z es e gt Z e lt gt Z 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 b NOILILOAS Fig 4 4 Screen for coag waveform selection Socket Selection The generator permits
67. rator are as follows Component Warranty Period Generator and footswitch One year from shipment date This warranty is in lieu of all other warranties expressed or implied including without limitation the warranties of merchantability and fitness for a particular purpose and of all other obligations or liabilities 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 the aggregate purchase price for the goods sold by the manufacturer to the customer There are no warranties which extend beyond the terms hereof The manufacturer disclaims any liability hereunder or elsewhere in connection with the sale of this product for indirect or consequential damages The manufacturer reserves the right to make changes in equipment built and or sold by it at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them The products listed above are manufactured in the United Kingdom Manufactured For Gyrus ACMI Inc 136 Turnpike Road Southborough MA 01772 2104 USA Customer Service USA Customer Service 1 888 524 7266 Technical Service 1
68. reen 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 option can be done at any time prior to surgery From the SuperPulse generator Idle state showing the Connect PK Cable or Insert Device message press and hold for 3 seconds the Mode Menu button on the SuperPulse generator front panel The SuperPulse generator VFD screen will show the Display Intensity screen press and release the Mode Menu button three times so the SuperPulse generator displays the following screen Enter Pin Code AA lt amp y O a YA Use these arrows to Backspace to Advance to next adjust digit being edited delete digit digit being edited Fig 4 13 Once the PIN code has been entered and is displayed correctly then press the Mode Menu button the display will change to that shown in Fig 4 14 below Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 11 0 ROC k gt lt Z es e gt p Z e lt gt Z b NOILILOAS gt lt Z es e gt Z e lt gt p Z SECTION 4 GENERAL INFORMATION ConfirmPin Code Fig 4 14 Re enter the PIN code using the same procedure once this is correctly displayed press the Mode Menu button the SuperPulse generator w
69. rn to the previous state 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 gt es Z es e gt a Z e lt gt Z Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 10 SECTION 4 GENERAL INFORMATION 4F ENABLING ADDITIONAL INSTRUMENTS VIA A PIN CODE As additional instruments are released for use with the SuperPulse generator these can be added to the SuperPulse generator software and enabled for use This is done by entering a PIN code into the SuperPulse generator using the front panel buttons The PIN must be entered twice in succession to enable these instruments Once the PIN has been entered the SuperPulse generator can then use these additional instruments Your local sales representative can provide you with this information as it becomes necessary or alternatively contact Customer Services as detailed at the front of this manual The enabling of these instruments is a one off action that must be performed in order to use these additional instruments The SuperPulse generator 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 sc
70. rument 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 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 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 Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Page 2 4 Part Number 144020 LB SECTION 2 PATIENT AND OPERATING ROOM SAFETY SuperPulse Generator Power Settings WARNING 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 th
71. s 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 PKT PKZ 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 TT 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 QO lt Z es e gt w Z e lt gt Z The appropriate display will flash and an audible alarm will sound when an output is activated Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 2 SECTION 4 GENERAL INFORMATION Super Loop 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 IMP
72. se for fuse replacement Switch to turn the Generator on off 4 Footswitch Connector The Footswitch is used to initiate the RF On amp Mode 5 Fuse Compartment Location of line fuses A WARNING Replace only with T series 10A 250V fuse certified to IEC 127 5 x 20 mm fuse Fig 4 17 gt lt Z es e gt Z e lt gt Z Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 4 13 SECTION 5 BEFORE SURGERY This section describes how to set up the Gyrus ACMI SuperPulse Endourology System before surgery Prior to using the system you should ensure that the following associated eguipment has been prepared for use A sterilised PlasmaKinetic Resectoscope or a urological endoscope with a 5 Fr or larger working channel A sufficient quantity of Normal Saline irrigant solution to complete the procedure A minimum of 2 appropriate PlasmaKinetic or Olympus TURis devices for the procedure to be performed A sterilized reusable PlasmaKinetic Connector Cable if required 5A Power up the SuperPulse Generator Install the SuperPulse Generator S NOILOAS Place the SuperPulse Generator on a table cart racking system or other stable platform that can be positioned as close as possible to the operative site during use Ensure that the SuperPulse Generator is standing on a flat firm surface and that it is not at r
73. sure that the SuperPulse software is updated with the latest available revision contact your local Gyrus ACMI sales representative technical service to arrange 6 NOLLO S Generator Displays Ensure only saline is used as the irrigant CHECK IRRIGANT CABLE Ensure both cable connections at the Olympus Resectoscope are secure gt Z a lt s DM Z O Gyrus ACMI PlasmakKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 9 1 SECTION 10 PERFORMANCE SPECIFICATIONS Environmental Conditions Transport and Storage Ambient Temperature Oto 50 C Relative Humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060mBar Operation Ambient Temperature 10 to 40 C Relative Humidity 10 to 90 non condensing Atmospheric pressure 500 to 1060mBar SuperPulse Generator Power Source Operating Range Nominal 100 120 V 220 240 Volts RMS 50 60 Hz 1000VA Regulation Voltage 90 132 198 264 Volts RMS Inlet Fuses Time lag 10A T10A 250V SuperPulse Generator Weight 8 kg 18 pounds approx SuperPulse Generator Overall Dimensions 410 x 410 x 135 mm 16 14 x 16 14 x 5 3 approx with rubber feet DxWxH SuperPulse Generator Earth Leakage Currents lt 300 HA Alarm Volume Adjustable between 40dB minimum and 65dB maximum at 1m This is an activation signal only Classification Class 1 IEC 60601 1
74. 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 accessories which should be discarded and replaced If the self test fails then all functions will be inhibited and no attempt should be made to use the generator Contact the appropriate address located on the front of the manual for assistance In the following list where indicated as recoverable this would be displayed as a fault symbol as described above ERROR TEXT STRING TYPE DESCRIPTION CODE SYSTEM RESET TR i Software execution failure watchdog reset 100 INTERNAL FAILURE ROM checksum failure SETTINGS CORRUPT TR Non volatile memory corrupt or not initialised d OO 13 NTERNAL FAILURE F Program failure unexpected value or state OUTPUT POWER FAIL TR Power generation fault on start up PK SP lt e e e gt Z J s gt lt es N Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 11 1 Il NOLDOUS es e e e gt Z J gt lt e N SECTION 11 coor _ CODE 200 10 i E 200 13 Ki m Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB TEXT STRING INTERNAL ERROR INTERNAL FAILURE INTERNAL FAILURE INTERNAL FAILURE INTERN
75. switched on by pressing the side marked 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 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 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 b NOILILOHAS 4D SuperPulse Generator Indicators Set up and Malfunction Displays 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 Select volume Fig 4 6 Screen for Alarm volume selection System Failure Displays
76. the PK SP modes in these circumstances 9 NOILOAS ThermoKinetic T and TS Modes Two of the ThermoKinetic outputs are available for use with all PK instrument configurations These are indicated as T1 and T2 on the power setting display In both options the output is automatically switched between PlasmakKinetic and Desiccate modes to produce more haemostasis than the pure PK outputs while still providing tissue vaporisation ThermoKinetic 1 T1 switches between PK2 and DES five hundred times per second while ThermoKinetic 2 T2 alternates between PK3 and DES approximately thirty times per second The actual tissue effects observed with T1 and T2 are toa 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 outputs indicated as TS1 and TS2 on the power setting display The method for providing increased hemostasis with these outputs relies on selectively modulating the SP2 output at half millisecond steps when contact with tissue is detected The TS2 has a higher crest factor than the TS1 output and so provides more hemostasis A vibration may be mildly discernable indicative of this process Desiccate DES Mode The DES o
77. tion 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 created during vaporisation Very high flow can suppress performance and some adjustment may be necessary to optimise the balance Placing the PK instrument against the tissue before activation is both good surgical practice and provides more repeatable performance The PlasmaKinetic Cystoscope Instruments may be used with other endoscopes such as urethroscopes or laser resectoscopes provided that the 5 Fr shaft and tip of the instrument will pass through the working channel When using the PlasmaKinetic Cystoscope Instruments some modification of technique is required when resecting villous bladder tumours if the tissue pieces produced by conventional resection techniques are to be avoided The use of firm pressure will amputate the villi so it is advisable to shrink these using the desiccate output combined with gentle application of the instrument prior to vaporisation Clearly this technique should only be used when there is an established histological diagnosis If an instrument is being used in the urethra care should be taken to avoid unnecessary activation and the risk of thermal damage beyond the applic
78. tissue visualisation of the working tip tissue sticking and limited power delivery 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 Page 1 1 1 NOLLOI HS Z x gt p hai Q Z T NOLLI HS Z a gt p Q Z SECTION 1 INTRODUCTION 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 out
79. to The generator has detected external interference and requires user use when attempting to activate 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 only be required once per instrument connection Generator flashes SP ELECTRODE IN Ensure that any SP supported instrument is only connected to the LHS after instrument attached Right Hand Side SP PK socket Check for damage to cable flex and instrument Move cables away from any possible source of interference e g other active electrosurgical systems Generator displays an error message e Check for activation of instrument within the working channel or during activation sheath e Contact may have been made with other equipment during activation such as cystoscope or other instrumentation e Remove the instrument from the operative site and inspect both it and the cystoscope for damage e Reset the Generator from the black mode footswitch e Check the accessories by activating the instrument in irrigating fluid contained in a bowl or similar remote from patient contact before proceeding with surgery e Ifthe fault recurs first replace the instrument and recheck e lf the fault continues contact technical service Generator does not respond to To ensure your SuperPulse generator is compatible with the latest instrument when attached range of Gyrus ACMI instruments please en
80. 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 and then withdrawing the plug from its receptacle WARNING Do not pull on the footswitch cable prior to unscrewing the connector locking ring Such action may cause malfunction or intermittent activation during use b Remove all gross matter blood mucus tissue by wiping each component with a cloth or gauze pad and a mild cleaning solution or detergent capable of removing organic deposits IMPORTANT Do not immerse in reprocessing solutions Do not use abrasive cleaning agents Do not use ultrasonic cleaners Product damage may otherwise result C Remove residual cleansing agents with a water dampened cloth WARNING The Footswitch is not designed to be sterilised Sterilisation could lead to product damage or malfunction during use Clean the SuperPulse Generator Use a mild antibacterial detergent on a damp cloth to clean the SuperPulse Generator Do not allow fluids to enter the SuperPulse Generator connectors Do not use caustic corrosive or abrasive cleaning materials The SuperPulse Generator can not be sterilised Page 8 2 S NOLLOHS gt P es e N e gt es e lt SECTION 9 OPERATING ROOM TROUBLESHOOTING Problem Suggestions Solutions No output power e Check cable and instr
81. ult during use Your sales contact can advise what accessories are available Always inspect the system accessories for damage prior to use In particular check the cables of any re usable accessory for possible insulation damage SuperPulse Generator CAUTION CAUTION CAUTION Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Fire Hazard Do not use extension cords 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 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 Do not stack equipment on top of the generator or place the generator on top of electrical equipment Do not 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 WARNING WARNING 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 inst
82. ument connections e Request assistance from Gyrus ACMI Service Support Generator resets during activation Check grounding of generator Check insulation of connector cable Check integrity of instrument Ensure no contact was made with other equipment during activation e Ensure approved footswitch is attached remember the last volume setting employed No display on the generator e Check the inlet fuse replace with the correct type if necessary request assistance from qualified service engineer if fault persists Generator flashes Attach PK Cable Verify that the cable connector is fully inserted after cable inserted Check for damage to cable flex Remove connector and inspect pins for damage Ensure only approved accessories are being used Generator flashes Insert Device or Ensure the connector cable contacts are clean and dry and have not Invalid Accessory after instrument been damaged during reprocessing attached Check instrument and cable integrity Ensure only approved instruments and accessories are being used Move cables away from any possible source of interference e g other active electrosurgical systems Ensure Olympus TURis connector cable is inserted in right hand SuperPulse socket Generator overheats Allow generator to cool down before re use Check that sufficient ventilation is provided around generator Ensure ambient temperature is within operating limits Generator displays Press mode
83. uperPulse Generator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the SuperPulse Generator lt O gt s DM P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 14 3 SECTION 14 EMC TABLES Recommended Separation Distances between Portable and Mobile RF Communications Eguipment and the SuperPulse Generator The SuperPulse Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SuperPulse Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications eguipment transmitters and the SuperPulse Generator as recommended below according to the maximum output power of the communications equipment VI NOLLOIHS Rated Maximum Separation Distance According to Frequency of Transmitter Output Power of Transmitter m Ww 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 3 5 ViJVP d 3 5 E1 VP d 7 E WP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where
84. utput is available with all PK instrument configurations The haemostatic effect will be dependent on the active instrument contact area and power setting The output is specifically controlled to prevent vaporisation from occurring and to provide a soft coagulation effect The depth of effect for a given PK instrument configuration and power setting will be dependent on the application time Activation Output Selection In common with conventional electrosurgical generators output activation is achieved using the blue and yellow pedals of the footswitch BLUE PEDAL Desiccate only Activation accompanied by flashing of the desiccate power display and an audible tone se zi Z p N re p s lt YELLOW PEDAL PlasmaKinetic 1 2 3 SuperPulse 1 2 3 and ThermoKinetic T1 T2 TS1 and TS2 depending on output mode selection Activation is accompanied by flashing of the SP PK or T power display and a higher pitched audible tone than the desiccate activate tone IMPORTANT Familiarise yourself with the two audible output tones to verify output selection as it is often difficult to visualise the footswitch pedals during surgery Gyrus ACMI PlasmaKinetic SuperPulse Generator Endourology USER MANUAL Part Number 144020 LB Page 6 2 SECTION 6 DURING SURGERY Changing Output Mode and Power Setting during Surgery In Ready mode power adjustment can be made at any time other than while activated or while the SuperPulse Ge

PK Superpulse User Manual 2

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