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

Generator 300 system
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Item # 32a
H
S
U
C
®
®
ARMONIC
CALPEL
LTRA
ISION
Generator 300 System User Manual
Manuel d'utilisation du Système de Générateur 300
Bedienungsanleitung für das Generator 300 System
Manuale dell'operatore del sistema generatore 300
Manual do utilizador do Sistema Gerador 300
Manual del usuario del sistema generador 300
Gebruikershandleiding generator 300-systeem
Brugermanual til generator 300 system
Generaattorijärjestelmän 300 käyttöopas
∂Á¯ÂÈÚ›‰ÈÔ XÚ‹Û˘ 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
PouÏívateºská príruãka pre systém Generator 300

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Summary of Contents for Ethicon Endo-Surgery ULTRACISION HARMONIC SCALPEL Generator 300

  • Page 1 Item # 32a ® ® ARMONIC CALPEL LTRA ISION Generator 300 System User Manual Manuel d’utilisation du Système de Générateur 300 Bedienungsanleitung für das Generator 300 System Manuale dell’operatore del sistema generatore 300 Manual do utilizador do Sistema Gerador 300 Manual del usuario del sistema generador 300 Gebruikershandleiding generator 300-systeem Brugermanual til generator 300 system...
  • Page 2 GEN04...

  • Page 3: Table Of Contents

    Table of Contents Chapter 1 – General Information ............1 Indications .
  • Page 4 GEN04...

  • Page 5: Chapter 1 - General Information

    Chapter 1 – General Information Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Important: The U Generator 300 System User Manual is designed to provide instructions for ® ® LTRA ISION ARMONIC CALPEL use of the U...
  • Page 6 User Manual GEN04...

  • Page 7: Chapter 2 - Principles Of Operation

    Chapter 2 – Principles of Operation The U System utilizes ultrasonic energy to enable hemostatic cutting and/or LTRA ISION ARMONIC CALPEL coagulation of soft tissue. The system consists of an ultrasonic generator, a foot switch, an optional hand- switching adaptor, a hand piece, and a variety of open and minimally invasive instruments. Important: The U Generator 300 System User Manual is designed to provide LTRA...

  • Page 8: Controls, Indicators, And Connections

    User Manual Controls, Indicators, and Connections Fig. 2-1 Front Panel READY When this indicator is green, the system is ready for activation. STANDBY Push this button to toggle between Standby and Ready modes. In Standby mode, this button, and the STANDBY icon, light up and all power is removed from the hand piece.
  • Page 9 Chapter 2 – Principles of Operation HAND PIECE This receptacle is used to connect the hand piece to the generator. RECEPTACLE HAND ACTIVATION When the indicator is green, hand activation on the hand switching adaptor is enabled. To disable the Hand Activation mode, depress the button. Upon power-up, the system defaults to Hand Activation mode disabled.

  • Page 10: Unpacking Instructions

    ARMONIC CALPEL separately. Upon receiving the ordered components, check for visible shipping damage. If damage is seen, contact your Ethicon Endo-Surgery representative. System components may include the following parts (for product codes, see Chapter 8 – System Specifications): Generator 300 – includes the generator, power cord, user manual, and service manual.

  • Page 11: Chapter 3 - System Setup And Operation

    Chapter 3 – System Setup and Operation System Startup Warning: Products manufactured or distributed by companies other than Ethicon Endo-Surgery, Inc. may not be compatible with the U System. Use of such products may lead to LTRA ISION ARMONIC CALPEL unanticipated results and possible injury to the user or patient.
  • Page 12 User Manual Connect the instrument and adaptor (or hand switching adaptor), if required, to the hand piece following instructions in their package inserts. Note: The hand switching adaptor must be at room temperature to function properly. Do not immerse in water to cool rapidly. After steam sterilization, allow hand switching adaptor to air cool for at least 15 minutes prior to use.

  • Page 13: System Operation

    Chapter 3 – System Setup and Operation System Operation Important: The U Generator 300 System User Manual is designed to LTRA ISION ARMONIC CALPEL provide instructions for use of the U Generator 300, Foot Switch, and LTRA ISION ARMONIC CALPEL Cart (see Chapter 8 –...

  • Page 14: System Shutdown

    User Manual If the system senses a generator, hand piece, or instrument fault during use, an audible alarm (tone with long pulses) will sound and a visual alarm indicator will appear on the control panel. (Refer to Chapter 4 – Troubleshooting or the Troubleshooting Guide to resolve the problem.) Warning: Place the generator in Standby mode before removing or replacing an instrument, hand switching adaptor or hand piece or when the system is not in use.

  • Page 15: Chapter 4 - Troubleshooting

    Chapter 4 – Troubleshooting The Generator 300 System supports a series of alarms and error codes to help in the identification and troubleshooting of component problems. These guides are meant as an adjunct to, but not a substitute for, clinical judgment and observations. Audible Indicators and Alarms Tone Possible Cause and Corrective Action...
  • Page 16 User Manual Error Code 1: Generator Error Code 1 indicates either there is a functional problem with the generator or the front panel button(s) were activated during power-up sequence. Cycle the power OFF then ON. If error persists, power off system and contact service.
  • Page 17 Chapter 4 – Troubleshooting The following are possible causes of an increase in hand piece temperature. To correct, complete the appropriate steps below and allow the hand piece to cool before resuming operation. The hand piece is still warm from recent steam sterilization. Allow the hand piece to cool at room temperature for at least 45 minutes or soak it in room-temperature sterile water for 5 minutes before resuming operation.
  • Page 18 User Manual e. Record the “XDUCER CAPACITANCE” value. Press the STANDBY button, if necessary, until it illuminates. Use the increase/decrease arrow keys to get to “Page 2 of 21”. Record the number opposite “XDUCER CAPACITANCE”. Press the STANDBY button until the Standby light turns off.
  • Page 19 Chapter 4 – Troubleshooting 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. If the error persists, install a test tip to isolate the problem.
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  • Page 21: Chapter 5 - Cleaning And Disinfection

    Chapter 5 – Cleaning and Disinfection Generator and Cart Cleaning Clean generator and cart following hospital protocol. Before cleaning, turn the generator main power off and unplug the power cord from the grounded electrical outlet. Warning: Spilling or spraying fluids on or into the generator or immersing the generator may result in damage to the generator and risk of shock or fire hazard.
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  • Page 23: Chapter 6 - Safety And Function Testing

    Chapter 6 – Safety and Function Testing Test hand piece, generator, and foot switch for safety and function according to hospital protocol. Refer to individual package inserts for safety and function testing for other multi-patient use components. Safety Test Generator: A qualified hospital technician should perform a leakage current test. Foot Switch: Examine the foot pedals, cable connectors, and cable for cracks or other damage and replace if damaged.
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  • Page 25: Chapter 7 - Warnings And Precautions

    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 U system. Use of such products may lead to...

  • Page 26: Instrument Warnings And Precautions

    User Manual • To avoid user injury, ensure that the test tip is clear of tissue, other instruments, or other objects before activating the system. • Do not simultaneously touch the patient and generator. • Place the generator in the Standby mode before removing or replacing an instrument, hand switching adaptor or hand piece or when system is not in use.

  • Page 27: Chapter 8 - System Specifications

    GEN04: Generator 300 HP054/HP055: Hand Piece (includes HST02 Test Tip and TLB01 Blade Wrench) Instruments and Adaptors: Contact your Ethicon Endo-Surgery representative for information about instruments available for use with this system. Some instruments may require use of an adaptor. Optional Components:...
  • Page 28 User Manual Date of Manufacture The date of manufacture may be determined by viewing the serial number on the rear panel of the generator.The fourth and fifth characters indicate the year of manufacture as follows: GN401 = year 2001 GN402 = year 2002 GN403 = year 2003 GN404 = year 2004 GN405 = year 2005...

  • Page 29: Chapter 9 - Warranty

    Ethicon Endo-Surgery’s obligation under this warranty is limited to the repair or replacement, at its option, of any product, or part thereof, which has been returned to Ethicon Endo-Surgery, Inc. or its Distributor within the applicable time period shown below and which examination disclosed, to Ethicon Endo- Surgery’s satisfaction, to be defective.
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  • Page 31: Chapter 10 - Symbols

    Chapter 10 – Symbols Fuse Safe working load Type CF Applied Part Test Hand Activation Temperature Volume Relative Humidity Minimum Attention - Consult Accompanying Documents/See Instructions For Use Maximum Non-Sterile Ready Date of Manufacture Standby Fragile Reorder Number This end up Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
  • Page 32 User Manual Manufacturer Authorized Representative in the European Community GEN04...
  • Page 33 Chapter 10 – Symbols GEN04...
  • Page 34 Manuel d’utilisation GEN04...

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