Gyrus Acmi PlasmaKinetic SuperPulse User Manual Download Page 1

Page: 1 / 52

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

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

0344

Summary of Contents for PlasmaKinetic SuperPulse

Page 1: ...ACMI 136 Turnpike Road Southborough MA 01772 2104 USA Gyrus Medical Ltd St Mellons Cardiff CF3 0LT United Kingdom Rx only Customer Service USA Customer Service 1 888 524 7266 Technical Service 1 800...

Page 2: ......

Page 3: ...or written permission of Gyrus ACMI Patents This product may be covered by one or more of the following US patents 5 944 715 6 004 319 6 013 076 6 015 406 6 045 549 6 056 746 6 074 386 6 090 106 6 093...

Page 4: ...cators and Displays 4 1 4B Output Mode Selection and Power Controls 4 3 4C SuperPulse Generator Indicators Set Up and Malfunction Displays 4 5 4D Changing the Display Language 4 9 4E Enabling Addition...

Page 5: ...om conventional bipolar generators Vapor Pulse Coagulation VPC VPC produces controlled coagulation of vascular pedicles using vapor focused pulses of energy VPC has been specifically tailored for deli...

Page 6: ...e 710003 Re usable Connector Cable Gyrus ACMI PK surgical instruments and other bipolar surgical instruments Fig 1 1 1F Instrument Description The instruments below are designed and rated to be used w...

Page 7: ...cm Micro Jaw Forceps 3 Pin PlasmaKinetic Forceps Micro Jaw 3601PK 33 cm Macro Jaw Forceps 3 Pin 3641PK 45 cm Micro Jaw Forceps 3 Pin PlasmaKinetic L Hook 3527PK 33 cm L Hook 3 Pin PK SEAL Open Forcep...

Page 8: ...n 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 fur...

Page 9: ...TION Electrical Shock Hazard Do not tamper with the generator housing or attempt to remove the control panel Refer to authorized personnel for service NOTE 1 There are no user serviceable parts within...

Page 10: ...Sterilization may render the instrument mechanically or electrically unsafe CAUTION Read the instructions warnings and cautions provided with the instrument accessories before using CAUTION Accessori...

Page 11: ...an instrument to the SuperPulse Generator or after navigation using the Mode Menu button the power settings for cutting and coagulation may be changed from previously selected values WARNING Confirm...

Page 12: ...posable or single use only 2G EMC Classification The SuperPulse System has been manufactured and tested to the following requirements Group 2 Class A as per IEC60601 1 2 2001 EMC PRECAUTIONS Medical e...

Page 13: ...splay Before proceeding with surgery confirm proper power settings are displayed on the generator Ensure the appropriate output setting is enabled for the desired surgical outcome Provide as much sepa...

Page 14: ...When disconnecting from the mains socket or from the generator cords should always be grasped by the plug Do not pull on the cord itself 3C Grounding of the Generator To ensure user safety the generat...

Page 15: ...ng an error condition the generator may be reset by pressing the Standby On button twice Up Down Arrows Depressing the up or down arrow when parameter change is permitted increases or decreases the pa...

Page 16: ...when the Cut or Coag pedal is pressed The lower half of the display indicates the output waveform type and power selected The left lower portion displays Plasmakinetic PK mode selection PK1 PK2 PK3 a...

Page 17: ...instrument being used NOTE If the Mode Menu button on the front panel is quickly pressed and released the generator enters a configuration state pressing and holding the Mode Menu button at any time...

Page 18: ...rst 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...

Page 19: ...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...

Page 20: ...g 4 6 Screen for Alarm volume selection System Failure Displays Non critical Soft Faults Shorting For jawed or grasping Gyrus ACMI PK instruments if an instrument short occurs an oscillating audible a...

Page 21: ...ure 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...

Page 22: ...hen accompanied by the Error Code 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...

Page 23: ...rpulse generator VFD screen will show the Display Intensity message press and release the Mode Menu button twice so the following screen is displayed Fig 4 12 Use the right hand arrow buttons to chang...

Page 24: ...at PIN and continue to allow the use of these instruments even after it has been switched off This facility can be setup in one of two ways Note If the PIN number entry screen cannot be accessed conta...

Page 25: ...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 wil...

Page 26: ...this port 2 Equipotential Connector The connection for the Potential Equalization Conductor terminates at this point 7 3 Power Switch Switch to turn the Generator on off Fuse Label Provides informatio...

Page 27: ...receptacle at the rear of the generator by orienting 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 clockw...

Page 28: ...the first 200 milliseconds of cut activation thereafter returning to the selected power output setting 6B PK Default Settings The power settings and output mode used for the intended procedures vary...

Page 29: ...entification code of the instrument 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 whi...

Page 30: ...procedures CAUTION If the generator is maintained in this Idle state between procedures and the same PK instrument type is employed for the next procedure then any adjustments made to the output setti...

Page 31: ...n can leave the jaws slightly open and twist as the power is applied If tissue adherence to the instrument jaws occurs regrasp and reapply When using PK forceps type instruments coagulating effect wil...

Page 32: ...tswitch from the rear panel of the Generator by first unlocking the retaining ring by rotating in a counter clockwise direction and then withdrawing the plug from its receptacle WARNING Do not pull on...

Page 33: ...s b Rinse thoroughly in running water c Remove residual cleaning agents with a water damp cloth d Dry the device thoroughly before sterilizing Sterilize the connector cable according to the sterilizat...

Page 34: ...integrity Ensure only Gyrus ACMI approved Instruments and accessories are being used Move cables away from any possible source of interference e g other active electrosurgical systems Generator overhe...

Page 35: ...Class 1 IEC 60601 1 Electromagnetic Compatibility Complies with IEC 60601 1 2 Defibrillator Proof Type BF equipment with isolated F applied part Each of the instrument terminals can withstand the eff...

Page 36: ...he following load curves apply to the fundamental power delivery capability of the generator alone They do not imply a given power output for any given instrument and connector cable configuration whe...

Page 37: ...MB Page 10 3 Half Power Coagulate Load Curves 0 10 20 30 40 50 60 70 0 200 400 600 800 1000 1200 Load Resistance Power Des VP1 VP2 VP3 Half Power Load Curves Half Power Cut Load Curves 0 20 40 60 80...

Page 38: ...0 60 80 100 120 140 0 200 400 600 800 1000 1200 Load Resistance Power Des VP1 VP2 VP3 Full Power Cut Load Curves 0 50 100 150 200 250 0 200 400 600 800 1000 1200 Load Resistance Power PK1 PK2 PK3 T1 T...

Page 39: ...30 Hz or 500 Hz depending on instrument type Vapor Pulse Waveforms VP3 VP2 VP1 Pulsed coagulation outputs with a limited maximum output voltages During the off periods no RF output occurs Repetition r...

Page 40: ...ept that it indicates that a service is required WARNING An error symbol indicates an equipment malfunction that may be hazardous Disconnect all accessories and switch the Generator off Switch the Gen...

Page 41: ...Not used 200 31 INTERNAL FAILURE F CURRLIM signal error DAC output 200 32 INTERNAL FAILURE F VOLTLIM signal error comparator input 200 33 INTERNAL FAILURE F BUSVOLTS signal error analogue input 200 34...

Page 42: ...e 200 85 INTERNAL FAILURE F 0V failure 200 86 INTERNAL FAILURE F RF_DET stuck high failure 200 87 INTERNAL FAILURE F PSU_STATUS failure 200 88 INTERNAL FAILURE F Mains input failure 200 89 INTERNAL FA...

Page 43: ...panel MODE MENU button stuck 400 20 BUTTON STUCK R Front panel STANDBY button stuck 400 21 FOOTPEDAL STUCK R Footswitch pedal state indeterminate 400 30 Not used 500 10 SERIAL COMMS R Serial port err...

Page 44: ...inst 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...

Page 45: ...of devices inside the package Numeral corresponds to the number of devices inside the package and must be present inside the diamond icon Represents the quantity of salable units inside the package CA...

Page 46: ...ndicator and vacuum fluorescent display are functioning normally via the user verification sequence which follows initialization Check Desiccation detector operation Check that the enclosure earth lea...

Page 47: ...vironment Guidance RF Emissions CISPR 11 Group 1 The SuperPulse Generator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer...

Page 48: ...ge IEC 61000 4 5 1 kV Differential Mode 2 kV Common Mode 1 kV Differential Mode 2 kV Common Mode Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short I...

Page 49: ...m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity...

Page 50: ...ion Distance According to Frequency of Transmitter m Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz d 3 5 V1 P 80 MHz to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 0 12 0 12 0...

Page 51: ...ilities 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 manufactu...

Page 52: ...NI PAR VOTRE FOURNISSEUR NE PAS UTILISER D AUTRE TYPE DE CORDON D ALIMENTATION WARNING ATTENTION RISK OF FIRE REPLACE FUSE AS MARKED RISQUE D INCENDIE REMPLACER LE FUSIBLE COMME INDIQUE THE POWER SUPP...

Search results

Summary of Contents for PlasmaKinetic SuperPulse

Reviews:

Related manuals for PlasmaKinetic SuperPulse

Brands by name

Popular brands

Gyrus Acmi PlasmaKinetic SuperPulse, User Manual

Search results

Summary of Contents for PlasmaKinetic SuperPulse

Reviews:

Related manuals for PlasmaKinetic SuperPulse

Brands by name

Popular brands