Gyrus Acmi PlasmaKinetic User Manual
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Gyrus Acmi PlasmaKinetic User Manual

Plasmakinetic superpulse generator
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PlasmaKinetic
SuperPulse Generator

USER MANUAL

Manufactured for:
Gyrus ACMI,
136 Turnpike Road
Southborough
MA 01772-2104
USA
Gyrus Medical Ltd
St Mellons
Cardiff
CF3 0LT
United Kingdom
0344
Rx only
Customer Service USA:
Customer Service: 1-888-524-7266
Technical Service: 1-800-621-3739
www.gyrusacmi.com
744000
Part Number: 114020-LB
2011-02

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Summary of Contents for Gyrus Acmi PlasmaKinetic

  • Page 1: User Manual

    PlasmaKinetic  SuperPulse Generator USER MANUAL Manufactured for: Gyrus ACMI, 136 Turnpike Road Southborough MA 01772-2104 Gyrus Medical Ltd St Mellons Cardiff CF3 0LT United Kingdom 0344 Rx only Customer Service USA: Customer Service: 1-888-524-7266 Technical Service: 1-800-621-3739 www.gyrusacmi.com 744000...
  • Page 3 ………OVERVIEW OF THE GYRUS ACMI SUPERPULSE GENERATOR This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI SuprePulse Generator and instruct you on its proper use. Copyright Gyrus Medical, Ltd. 2010. All rights reserved. No part of this...

  • Page 4: Table Of Contents

    Enabling Additional Instruments via a PIN code 4-11 BEFORE SURGERY Power up the SuperPulse Generator Select the Appropriate PK/SP Instrument(s) for the Procedure  Steam Sterilise the PK Connector Cable, PlasmaKinetic Resectoscope or appropriate urological endoscope Connect the PK Connector Cable  Prepare the PlasmaKinetic Resectoscope or urological endoscope ...

  • Page 5: Introduction

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

  • Page 6: Indications For Use

    1 C. Indication for Use The Gyrus ACMI PK Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated haemostasis is required in open, endoscopic and laparoscopic surgical procedures.
  • Page 7 Desiccated (DES) mode. A third 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.
  • Page 8 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. 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.

  • Page 9: Patient And Operating Room Safety

    Direct contact between activated monopolar accessories and SP generator connected accessories could damage the SP generator. If such damage is suspected, the SP generator should be returned to Gyrus ACMI for inspection. WARNING Use with caution in the presence of internal or external pacemakers. Interference from an electrosurgical current can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely.

  • Page 10: Servicing/Equipment Disposal

    CAUTION The Gyrus ACMI SuperPulse Endourology System should only be activated with the working tip of the instrument completely immersed in 0.9% w/v 150mMol/l sodium chloride solution. For convenience, this will be referred to within the remainder of this manual as normal saline.

  • Page 11: Fire/Explosion

    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 Page 2-3 Part Number: 144020-LB...

  • Page 12: During Surgery

    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 PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 2-4...
  • Page 13 Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 2-5 Part Number: 144020-LB...

  • Page 14: After Surgery

    • 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...
  • Page 15 Should any unintentional effects appear upon other equipment when using the generator, repositioning the generator, the connecting leads or other equipment may alleviate the problem. It may also help to use different electrical supply sockets for any affected equipment Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 2-7...

  • Page 16: Installation

    Routine Maintenance of the SuperPulse Generator It is recommended that the SuperPulse Generator be inspected by qualified service personnel in accordance with Section 13, Periodic Equipment Safety Checks. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 3-1 Part Number: 144020-LB...

  • Page 17: General Information

    SECTION 4 GENERAL INFORMATION Gyrus ACMI SuperPulse Generator Indicators and Displays Red warning lamp Gyrus Medical Ltd Superpulse System (c) 2003 Version V2.00 Active instrument Standby / Standby / On indicator Mode / On Button indicator Menu Connector Cable Button...
  • Page 18 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.
  • Page 19 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 ...
  • Page 20 Output mode selection can only be performed with an instrument and connector cable attached to the generator. The range of modes available will depend on the type of Gyrus ACMI PK instrument being used. NOTE If the Mode / Menu button is quickly pressed and released the generator enters a menu based configuration state, pressing and holding the Mode / Menu button at any time exits this state.
  • Page 21 SECTION 4 GENERAL INFORMATION Mode Selection using Gyrus ACMI PK/SP Instruments - There are three  PlasmaKinetic Modes shown as PK1, PK2 and PK3, which produce a tissue effect increasing from PK1 to PK3 (PK3 delivers power more effectively to higher impedance tissue than PK1).
  • Page 22 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 Page 4-6 Part Number: 144020-LB...

  • Page 23: Superpulse Generator Indicators, Set-Up And Malfunction Displays

    System Failure Displays Non-critical (Soft) Faults Shorting - For Gyrus ACMI Urology instruments, if a Generator “Output Shorted” message occurs the power will be removed for 0.5 seconds and the activation tone will also be terminated for this time. If the pedal is kept depressed, RF activation will resume. If three short circuits occur in 2 seconds then RF activation is stopped until the pedal is released and pressed again.
  • Page 24 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 Page 4-8...
  • Page 25 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 Page 4-9 Part Number: 144020-LB...

  • Page 26: Changing The Display Language

    Once the language has been changed from the factory default of English, the SuperPulse will continue to use the selected language for all instructions, performance information and error messages on the generator VFD display. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 4-10...

  • Page 27: Enabling Additional Instruments Via A Pin Code

    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 Page 4-11...
  • Page 28 < > 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 Page 4-12 Part Number: 144020-LB...
  • Page 29 & Mode. Fuse Compartment Location of line fuses. WARNING: Replace only with T-series 10A, 250V fuse certified to IEC 127 (5 x 20 mm fuse). Fig 4.17 Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 4-13 Part Number: 144020-LB...

  • Page 30: Before Surgery

    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 equipment has been prepared for use:   A sterilised PlasmaKinetic Resectoscope or a urological endoscope with a 5 Fr.

  • Page 31: Select The Appropriate Pk/Sp Instrument(S) For The Procedure

    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.

  • Page 32: Steam Sterilise The Pk Connector Cable, Plasmakinetic  Resectoscope Or Appropriate Urological Endoscope

    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. 5D. 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.
  • Page 33 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.

  • Page 34: During Surgery

    SECTION 6 DURING SURGERY This section describes how to use the Gyrus ACMI SuperPulse Endourology System during surgery. 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.
  • Page 35 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.
  • Page 36 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.

  • Page 37: Techniques To Optimize Performance

    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 ...

  • Page 38: After Surgery

    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.

  • Page 39: System

    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 ...

  • Page 40: Operating Room Troubleshooting

    To ensure your SuperPulse generator is compatible with the latest instrument when attached. range of Gyrus ACMI instruments please ensure that the SuperPulse software is updated with the latest available revision - contact your local Gyrus ACMI sales representative / technical service to arrange.

  • Page 41: Performance Specifications

    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 PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-1 Part Number: 144020-LB...
  • Page 42 SuperPulse Generator. Each accessory will self-impose an upper set power limit for the SuperPulse Generator. Power Linearity 230V 50 Hz a.c. Measured Power Linearity (PK3 into 150) Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-2 Part Number: 144020-LB...
  • Page 43 Half Power Coagulate Load Curves 1000 1500 Load Resistance Half Power Cut Load Curves 1000 1500 Load Resistance Half Pow er SP Load Curve 1000 Load Resistance Half Power Load Curves Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-3 Part Number: 144020-LB...
  • Page 44 Full Pow er SP Load Curve 1000 Load Resistance Full Power Coagulate Load Curves 1000 1500 Load Resistance Full Power Cut Load Curves 1000 1500 Load Resistance Full Power Load Curves Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-4 Part Number: 144020-LB...
  • Page 45 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. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-5 Part Number: 144020-LB...
  • Page 46 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. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 10-6 Part Number: 144020-LB...

  • Page 47: Error And Fault Codes

    Power generation fault on start up (PK) INTERNAL FAILURE Power generation shutdown fault OUTPUT POWER FAIL Power generation fault on start up (SP) SYSTEM RESET Software execution failure INTERNAL ERROR Background loop timing Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 11-1 Part Number: 144020-LB...
  • Page 48 Analogue reference failure [POST check] INTERNAL FAILURE CLAMP_SET failure [POST check] INTERNAL FAILURE BOOST_SET failure [POST check] INTERNAL FAILURE CURRLIM_SET failure [POST check] INTERNAL FAILURE PEAK_SET failure [POST check] Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 11-2 Part Number: 144020-LB...
  • Page 49 ----- 12-13 Not used OUTPUT SHORTED Excessive RF output INTERNAL ERROR Impedance V, I feedback circuit error INTERNAL ERROR SP board not supplying RF energy 17-19 Reserved Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 11-3 Part Number: 144020-LB...
  • Page 50 Not used ---- SERIAL COMMS Serial port error **To report an accessory failure, contact the appropriate address located on the front of the manual for assistance. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 11-4 Part Number: 144020-LB...

  • Page 51: Explanation Of Symbols

    This symbol indicates the receptacle to which the generator footswitch should be attached. Waste electrical and electronic equipment (WEEE) Storage Conditions Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 12-1 Part Number: 144020-LB...
  • Page 52 # -Numeral corresponds to the number of devices inside the package and must be present inside the diamond icon. Represents the quantity of salable units inside the package. When a product is manufactured for Gyrus ACMI. Manufactured for: Rx only CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a Physician or Dentist.

  • Page 53: Periodic Equipment Safety Checks

    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. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 13-1...
  • Page 54 Details of these tests should be recorded in an equipment log with the date of test for future reference. Contact the service repair centre selected by the manufacturer, should a unit fault be suspected. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 13-2...

  • Page 55: Emc Tables

    Harmonic Emissions Class A IEC 61000-3-2 Voltage Fluctuations / Complies Flicker Emissions IEC 61000-3-3 Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 14-1 Part Number: 144020-LB...
  • Page 56 Field commercial hospital IEC 61000-4-8 environment. NOTE: U is the a.c. mains voltage prior to application of the test level. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 14-2 Part Number: 144020-LB...
  • Page 57 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. 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 Page 14-3...
  • Page 58 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. Gyrus ACMI PlasmaKinetic SuperPulse Generator (Endourology) USER MANUAL Page 14-4 Part Number: 144020-LB...

  • Page 59: Limited Warranty

    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...
  • Page 60 SECTION 16 NOTE THE UL APPROVAL APPLIES TO GYRUS ACMI PRODUCTS ONLY 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...

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