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SECTION 16 UL

Gyrus ACMI PlasmaKinetic SuperPulse Generator

USER MANUAL

UL

Part Number: 144012-MB

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

21FA

CAUTION

MISE EN GARDE

USE ONLY THE POWER CORD PROVIDED BY
YOUR PRODUCT SUPPLIER.
DO NOT USE ANY OTHER POWER SUPPLY CORD.

UTILISER UNIQUEMENT LE CORDON
D’ALIMENTATION FOURNI PAR VOTRE

FOURNISSEUR. NE PAS UTILISER D’AUTRE

TYPE DE CORDON D’ALIMENTATION.

WARNING

ATTENTION

RISK OF FIRE
REPLACE FUSE AS MARKED

RISQUE D’INCENDIE
REMPLACER LE FUSIBLE COMME INDIQUE

THE POWER SUPPLY CORD PROVIDED IS INTENDED
FOR NORTH AMERICAN 110V USE. THIS POWER CORD
IS UL LISTED. TYPE SJT, RATED 120V AT 10A MINIMUM.
FOR OPERATION AT OTHER MAINS SUPPLY VOLTAGES
CONSULT YOUR LOCAL PRODUCT REPRESENTATIVE
FOR ADVICE OR THE PROVISION OF A REPLACEMENT
POWER CORD.

LE CORDON D’ALIMENTATION EST CONCU

POUR UNE UTILISATION EN AMERIQUE

DU NORD SOUS UNE TENSION DE 110V. CE

CORDON D’ALIMENTATION EST DE TYPE UL,

SJT. ALIMENTATION 120V ET 10A MINIMUM.

CONTACTER VOTRE REPRESENTANT LOCAL

POUR UNE UTILISATION A UN AUTRE VOLAGE.

CAUTION

MISE EN GARDE

E176665

UL

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Содержание PlasmaKinetic SuperPulse

Страница 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...

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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