Ethicon Endo-Surgery ULTRACISION HARMONIC SCALPEL Generator 300, User Manual

Page 1: ...rador 300 Manual del usuario del sistema generador 300 Gebruikershandleiding generator 300 systeem Brugermanual til generator 300 system Generaattorijärjestelmän 300 käyttöopas Á ÂÈÚ ÈÔ XÚ ÛË ÙÔ ÛÙ Ì ÙÔ ÂÓÓ ÙÚÈ 300 Användarhandledning för generator 300 systemet Instrukcja obs ugi systemu generatora 300 Generátor 300 rendszer Használati útmutató UÏivatelská pfiíruãka systému Generator 300 PouÏívate...

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Page 3: ... System Startup 7 System Operation 9 System Shutdown 10 Chapter 4 Troubleshooting 11 Audible Indicators and Alarms 11 Error Codes 11 Chapter 5 Cleaning and Disinfection 17 Generator and Cart Cleaning 17 Foot Switch Cleaning 17 Chapter 6 Safety and Function Testing 19 Safety Test 19 Function Test 19 Calibration 19 Chapter 7 Warnings and Precautions 21 System Warnings and Precautions 21 Instrument W...

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Page 5: ...Note Refer to package inserts provided separately for information about the Hand Piece Hand Switching Adaptor Adaptors Test Tip and Instruments prior to using the system Indications The ULTRACISION HARMONIC SCALPEL System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired The ULTRACISION HARMONIC SCALPEL System instruments can be used as an adjunct ...

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Page 7: ...ator to mechanical motion The transducer is connected to an amplifier which amplifies the motion produced by the transducer and relays it to the instrument Instrument The mechanical motion from the hand piece advances to the instrument transmitting ultrasonic energy which enables hemostatic cutting and or coagulation of tissue Note Throughout this manual instrument s refers to ULTRACISION HARMONIC...

Page 8: ...evel may be adjusted when the generator is in Ready or Standby mode 4 POWER This switch controls the main electrical power to the generator 5 VOLUME Turn this knob to adjust the volume of the activation tones A tone will sound indicating the volume level selected 6 MIN Indicates the user settable minimum power level setting When this power level is activated by foot switch or hand switch the MIN i...

Page 9: ...codes will appear on this display Fig 2 2 Back Panel 13 FOOT SWITCH Identical receptacles allow connection of up to two foot switches for RECEPTACLES user convenience If only one foot switch is used connect to either receptacle 14 POTENTIAL This terminal provides a means for connection to a Potential Equalization EQUALIZATION Conductor TERMINAL 15 FUSES See the ULTRACISION HARMONIC SCALPEL Generat...

Page 10: ...ludes a troubleshooting guide see back pocket of manual binder Remove the self adhesive guide s backing and adhere the guide to the top panel of the generator Placement guides for the Troubleshooting Guide are found on the generator s top panel Foot Switch includes the foot switch and detachable cable assembly Note The foot switch is required if the system will be used with coagulating shears or i...

Page 11: ...Connect the line cord into the AC inlet located on the generator s rear panel and into an appropriately grounded outlet If the power cord is wrapped around the cart handle it must be completely removed from the cart handle prior to plugging it into the power outlet Warning Verify that the outlet voltage correctly corresponds to the generator s requirements see Chapter 8 System Specifications Conne...

Page 12: ... or incorrect hand piece a fault will appear on the graphic display the power levels will not be visible and an audible alarm will sound Refer to Chapter 4 Troubleshooting or the Troubleshooting Guide 8 Power Levels Upon startup the generator defaults to power level 3 MIN and 5 MAX The minimum MIN power level is user settable from power levels 1 to 5 To adjust the power level depress the up down a...

Page 13: ...hooting or the Troubleshooting Guide Warning To avoid user or patient injury ensure that the instrument is clear of other instruments drapes the patient or other objects during the system check Safety measures in accordance with hospital protocol taken in the presence of aerosols should be in effect during the system check Note The foot switch or hand switch must be depressed until the system chec...

Page 14: ...e system is not in use System Shutdown 1 Turn the generator power switch off and remove power cord from outlet 2 Disconnect the hand piece instrument and adaptor or hand switching adaptor if used and process them as indicated in their respective package inserts 3 Clean the generator and cart and disinfect the foot switch es following hospital protocol for recommendations refer to Chapter 5 Cleanin...

Page 15: ... with too much tissue Reduce the amount of tissue in contact with the instrument If tone persists carefully remove any tissue that has collected in the distal end of the instrument shaft 2 Hand piece and or blade fault Press TEST to identify source of fault Prolonged solid tone during Hand piece and or blade fault Press TEST to identify source of fault activation exceeds 10 seconds Alarm two tone ...

Page 16: ... have collected in the distal end of the instrument shaft Tighten instrument using blade wrench and carefully remove tissue from distal end of instrument sheath Press STANDBY to clear error code and return to Ready mode Activate system If the pre run test is running ensure instrument is in air If using shears ensure jaws are open and not in contact with any objects during pre run test Note Inspect...

Page 17: ...ny objects during pre run test Note Inspect the blade wrench hub for cracks or wear before use If damage is seen replace the blade wrench Before use after autoclaving cool the blade wrench at room temperature for at least 45 minutes or soak it in room temperature sterile water for 5 minutes 3 If the error persists install a test tip to isolate the problem Press TEST button If system indicates a ha...

Page 18: ...erns may prevent this update from occurring and subsequently make the hand piece diagnostics more sensitive to temperature The steps above will cause an update of the hand piece parameter and return the system to designed sensitivity Warning To avoid user or patient injury ensure that the instrument is clear of other instruments drapes the patient or other objects before pressing TEST Safety measu...

Page 19: ...r 5 minutes Warning To avoid user or patient injury ensure that the instrument is clear of other instruments drapes the patient or other interference before pressing TEST Safety measures in accordance with hospital protocol taken in the presence of aerosols should be in effect while in Test mode Note Do not run the Test mode while an electrosurgical generator is being activated in the room Interfe...

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Page 21: ...ith warm tap water 4 Dry with a clean soft cloth Foot Switch Cleaning The foot switch and cable should be cleaned after each use as follows 1 Disconnect the foot switch from the generator 2 Prepare a neutral pH enzymatic detergent according to the detergent manufacturer s directions 3 With the cable securely attached to the foot switch soak the foot switch and cable in the detergent solution for t...

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Page 23: ...from 1 to 5 7 Turn the generator off Wait five seconds then turn the generator back on Wait ten seconds then confirm MIN Power Level 3 and MAX Power Level 5 are displayed Confirm the generator is not being activated unexpectedly 8 Place the generator in Ready mode by depressing the STANDBY button Hold the hand piece so that the distal portion is in the air and step on the MAX foot switch pedal bef...

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Page 25: ... spilled on it After removing the instrument examine the tissue for hemostasis If hemostasis is not present appropriate techniques should be used to achieve hemostasis Products manufactured or distributed by companies other than Ethicon Endo Surgery Inc may not be compatible with the ULTRACISION HARMONIC SCALPEL system Use of such products may lead to unanticipated results and possible injury to t...

Page 26: ...hazard In case of system failure ensure the availability of the appropriate backup equipment relevant to the specific procedure Instrument Warnings and Precautions Blades All blades have an intermittent operation of 15 second on off intervals unless the duty cycle is explicitly specified otherwise in the individual instrument package inserts Coagulating Shears During prolonged activation in tissue...

Page 27: ...nerator When the hand switch is used availability of the foot switch is recommended Degree of Protection Against Electric Shock Type CF Applied Part Class of Protection Against Electric Shock Class I Safety Standards EN 60601 1 Degree of Protection Against Harmful Ingress of Water Generator Ordinary equipment Footswitch IPX8 Safety Classification UL 2601 1 CSA C22 2 601 1 EN 60601 1 Mains Input Vo...

Page 28: ...ded by particular country requirements Receptacle IEC 60320 C13 with straight non angled cord entry Cord Length 2 44 4 6 meters nominal Current Rating 10A Minimum conductor size cross sectional area 1 0mm2 copper Voltage Rating 250 VAC minimum Wiring international Cordage Type HAR Item to have certification by at least one of the following agencies VDE ASTA SEMKO KEMA LCIE DFT IMQ SEV Duty Cycle D...

Page 29: ... or environmental standards for similar products generally accepted in the industry Ethicon Endo Surgery s products are warranted for the following periods after delivery to the original purchaser Hand Pieces Nine 9 Months Parts and Labor Generators One 1 Year Parts and Labor Carts One 1 Year Parts and Labor Foot Switches and Cables One 1 Year Parts and Labor Sterilization Tray One 1 Year Parts an...

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Page 31: ...uipotential Chapter 10 Symbols 27 GEN04 Fuse Safe working load Test Hand Activation Volume Minimum Maximum Ready Standby Reorder Number Caution Federal USA law restricts this device to sale by or on the order of a physician ON OFF Time for Intermittent Operation Refer to the individual package insert and or Chapter 7 Warnings and Precautions for additional specifications Foot switch Category AP An...

Page 32: ...Manufacturer Authorized Representative in the European Community User Manual 28 GEN04 ...

Page 33: ...Chapter 10 Symbols 29 GEN04 ...

Page 34: ...Manuel d utilisation 30 GEN04 ...