Gyrus Acmi PlasmaKinetic SuperPulse User Manual
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Gyrus Acmi PlasmaKinetic SuperPulse 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: 144012-MB
2011-02

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Summary of Contents for Gyrus Acmi PlasmaKinetic SuperPulse

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

  • Page 4: Table Of Contents

    Enabling Additional Instruments via a PIN code 4-10 BEFORE SURGERY Power up the Generator Select and Connect the Connector Cable Attach Gyrus ACMI PK Instrument to the PK Connector Cable DURING SURGERY Recommendations During Surgery PK Default Settings Activation: Output Selection and Audible Tones...

  • Page 5: Introduction

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

  • Page 6: System Description

    710003 • Re-usable Connector Cable • Gyrus ACMI PK surgical instruments and other bipolar surgical instruments. Fig 1.1 Instrument Description The instruments below are designed and rated to be used with the Generator. For convenience and to improve safety during use, all the dedicated instruments have an internal classification code, which is interrogated by the Generator when the instrument is attached.

  • Page 7: Connector Cable Description

    3905 5 Pin Dual Footswitch Connector Cable This optional re-usable cable allows the connection of two Footswitches to the Generator. Description Model No Dual Footswitch Connector Cable 710003 Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 1-3 Part Number: 144012-MB...

  • Page 8: 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.

  • Page 9: Servicing/Equipment Disposal

    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. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 2-2 Part Number: 144012-MB...

  • Page 10: Before Surgery

    Always inspect the system accessories for damage prior to use. In particular, check the cables of any re-usable accessory for possible insulation damage. CAUTION Use only Gyrus ACMI approved accessories supplied for use with this product. Product damage or accessory failure may otherwise result during use. SuperPulse Generator WARNING Electric Shock Hazard;...

  • Page 11: During Surgery

    Fire Hazard: Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories, which are activated or hot from use, can cause a fire. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 2-4...

  • Page 12: After Surgery

    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. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 2-5 Part Number: 144012-MB...
  • Page 13 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 mains supply sockets for any affected equipment Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 2-6 Part Number: 144012-MB...

  • Page 14: Installation

    SECTION 3 INSTALLATION The electrosurgical generator described in this manual, in conjunction with the Gyrus ACMI PK Instruments, is designed to provide advanced electrosurgical effects during endoscopic surgery. Responsibility of the Manufacturer The manufacturer is responsible for safety, reliability and performance of the equipment only if: ...

  • Page 15: General Information

    SECTION 4 GENERAL INFORMATION Gyrus ACMI SuperPulse Generator Indicators and Displays Red warning lamp Gyrus Medical Ltd Superpulse System (c) 2003 Version V2.22 Active instrument Standby Standby / On indicator Mode / / On indicator Menu Button Connector Cable Button...
  • Page 16 The right portion displays Vapor Pulse Coagulation (VPC) mode selection VP1, VP2, VP3 and standard desiccate (DES), with the default power setting from 10 to 120 dependent on the type of Gyrus ACMI PK instrument attached. The VPC mode is only available with Gyrus ACMI PK instruments.

  • Page 17: Output Mode Selection And Power Controls

    GENERAL INFORMATION Output Mode Selection and Power Controls When using a Gyrus ACMI PK instrument, the generator default power, and waveforms for that instrument will be selected. Power Up/Down - These buttons adjust the power setting; the yellow arrow buttons for the PlasmaKinetic...
  • Page 18 The yellow footswitch pedal is used to administer PK (cut) and ThermoKinetic 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 PK instruments. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 4-4 Part Number: 144012-MB...

  • Page 19: Superpulse Generator Indicators, Set-Up And Malfunction Displays

    For the bargraph display thirteen diamonds are displayed initially with the number reducing as the impedance rises. The audible tone that accompanies the visual display starts at a high pitch and falls as the impedance increases. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 4-5 Part Number: 144012-MB...
  • Page 20 Non-critical (Soft) Faults Shorting For jawed or grasping Gyrus ACMI PK instruments, if an instrument short occurs an oscillating audible alert is sounded and the display shows the symbol “Regrasp”. The surgeon should release the instrument jaw and reposition the tissue.
  • Page 21 This condition can be inadvertently caused by the inverting the footswitch or standing on a pedal as the generator is switched on. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 4-7...
  • Page 22 The electrical power cord; footswitch cable and protective earth cable are connected to the generator through fittings on the rear panel (Fig 4.17). A five-way cable may be available to enable use of tri-polar instruments. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 4-8...

  • Page 23: 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 USER MANUAL Page 4-9...

  • Page 24: 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 USER MANUAL Page 4-10...
  • Page 25   < > 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 USER MANUAL Page 4-11 Part Number: 144012-MB...
  • Page 26 The Footswitch is used to initiate the RF On & 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 USER MANUAL Page 4-12 Part Number: 144012-MB...

  • Page 27: Before Surgery

    Attach Gyrus ACMI PK Instrument to PK Connector Cables Connect the Gyrus ACMI PK instrument to the PK Connector Cable by aligning the two connector halves and pushing together. Once connection is made the generator display will change to the default settings appropriate to the instrument being used.

  • Page 28: During Surgery

    The Generator incorporates a Vapor Pulse Coagulation (VPC) mode, which is the default applied to many of the Gyrus ACMI PK instruments. This mode is designed to reduce both thermal margins and tissue sticking, providing controlled and repeatable outcomes under a variety of surgical situations.

  • Page 29: Changing Output Mode And Power Setting During Surgery

    When using a Gyrus ACMI PK instrument, adjustment of output modes: VP1, VP2, VP3 and PK1, PK2, PK3, T1 and T2, can be changed at any time other than while activating or while the generator displays a malfunction.

  • Page 30: Changing Accessories Between Procedures

    Any adjustments to the PK Generator settings made during the previous procedure will be overridden. Switching the power off will clear all prior PK output adjustments. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 6-3 Part Number: 144012-MB...

  • Page 31: Techniques To Optimize Performance

    • When using the PK modes with the Gyrus ACMI PK L-Hook, try to avoid excessive build up of coagulum between the hooks. This will diminish coagulation performance and increase smoke production during cutting.

  • Page 32: After Surgery

    Use a mild antibacterial detergent on a damp cloth to clean the generator. Do not allow fluids to enter the generator connectors. Do not use caustic, corrosive, or abrasive cleaning materials. The generator cannot be sterilized. Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 8-1...

  • Page 33: Cleaning And Sterilizing The Pk Connector Cable

    Sterilize the connector cable according to the sterilization procedure described in the Connector Cable Instructions For Use. IMPORTANT The connector cable supplied as part of the Gyrus ACMI PlasmaKinetic SuperPulse System is intended for 20 re-use cycles only. WARNING Do not attempt to re-use PlasmaKinetic Instruments. Heat or chemical sterilization may render the instrument mechanically or electrically unsafe.

  • Page 34: Operating Room Troubleshooting

    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. Gyrus ACMI PlasmaKinetic SuperPulse Generator...

  • Page 35: Performance Specifications

    A constant crest factor of 1.4 nominal for all vaporize outputs; 1.4 to 6.3 for desiccate waveforms. Power Maximum power 200 watts into 400 Ohms, PK modes 128 watts into 70 Ohms, DES modes 90 watts into 80 Ohms, VP modes Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Part Number: 144012-MB Page10-1...
  • Page 36 CAUTION Some electrode settings will not allow full power to be administered. Power Linearity 230V 50 Hz a.c. Measured Power Linearity (PK3 into 150) Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 10-2 Part Number: 144012-MB...
  • Page 37 SECTION 10 PERFORMANCE SPECIFICATIONS Half Power Coagulate Load Curves 1000 1200 Load Resistance Half Power Cut Load Curves 1000 1200 Load Resistance Half Power Load Curves Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 10-3 Part Number: 144012-MB...
  • Page 38 1200 Load Resistance Full Power Cut Load Curves 1000 1200 Load Resistance MR2 Setting Fixed Power Output Load Curve (230V a.c. 50Hz) 1000 Impedance (R) Full Power Curves Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 10-4 Part Number: 144012-MB...
  • Page 39 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 USER MANUAL Page 10-5 Part Number: 144012-MB...

  • Page 40: Error And Fault Codes

    Power generation shutdown fault OUTPUT POWER FAIL Power generation fault on start up (SP) SYSTEM RESET Software execution failure INTERNAL ERROR Background loop timing INTERNAL ERROR Continuous test timing Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 11-1 Part Number: 144012-MB...
  • Page 41 COAG_CUT failure [POST check] INTERNAL FAILURE PK_CUT_COAG failure [POST check] INTERNAL FAILURE PK_SKT_SET failure [POST check] INTERNAL FAILURE SUPERPULSE_RELAY failure [POST check] INTERNAL FAILURE NO_RF failure [POST check] Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 11-2 Part Number: 144012-MB...
  • Page 42 BUTTON STUCK Front panel : CUT (left) DOWN button stuck BUTTON STUCK Front panel : blue UP button stuck BUTTON STUCK Front panel : blue DOWN button stuck Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 11-3 Part Number: 144012-MB...
  • Page 43 Footswitch pedal state indeterminate 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 USER MANUAL Page 11-4 Part Number: 144012-MB...

  • Page 44: 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 USER MANUAL Part Number: 144012-MB...
  • Page 45 # -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 46: Periodic Equipment Safety Checks

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

  • Page 47: Emc Tables

    Harmonic Emissions Class A IEC 61000-3-2 Voltage Fluctuations / Complies Flicker Emissions IEC 61000-3-3 Gyrus ACMI PlasmaKinetic SuperPulse Generator USER MANUAL Page 14-1 Part Number: 144012-MB...
  • Page 48 (50/60 Hz) Magnetic a typical location in a typical 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 USER MANUAL Page 14-2 Part Number: 144012-MB...
  • Page 49 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 USER MANUAL Page 14-3...
  • Page 50 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 USER MANUAL Page 14-4 Part Number: 144012-MB...

  • Page 51: Limited Warranty

     ® PlasmaKinetic 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 52 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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