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Johnson & Johnson ETHICON ENDO-SURGERY HARMONIC 300 Service Manual

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H
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Generator 300 System
ARMONIC
Service Manual

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Summary of Contents for Johnson & Johnson ETHICON ENDO-SURGERY HARMONIC 300

  • Page 1 ™ Generator 300 System ARMONIC Service Manual...
  • Page 2 GEN04...

  • Page 3: Table Of Contents

    Table of Contents Introduction – Harmonic Generator 300 System ......... 3 Scope .
  • Page 4 Service Manual Chapter 11 – Advanced Error Codes ...........39 Error Code Display .

  • Page 5: Introduction - Harmonic Generator 300 System

    Introduction Scope This manual and the equipment it describes are for use only by qualified Biomedical Service Personnel. It is intended only as a guide for technical maintenance of the H ™ Generator 300 System. ARMONIC This manual is intended to be a companion to the H ™...
  • Page 6 Service Manual GEN04...

  • Page 7: Chapter 1 - Warnings, Precautions And Notes

    Chapter 1 - Warnings, Precautions and Notes Warnings and Precautions • This equipment, in conjunction with the accessories, is intended to produce high-frequency mechanical energy which enables hemostatic cutting and/or coagulation of soft tissue. • Safe and effective ultrasonic surgery is dependent not only upon equipment design, but also, to a large extent, upon factors under control of the operator.

  • Page 8: Notes

    Service Manual • Do not connect the The H ™ Generator 300 System to an ungrounded outlet. Grounding ARMONIC reliability can only be achieved when this equipment is connected to a hospital-grade receptacle. • 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.

  • Page 9: Chapter 2 - General Description

    Chapter 2 - General Description System Description The H ™ Generator 300 System utilizes ultrasonic energy to enable hemostatic cutting and/or ARMONIC 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. Note: Throughout this manual “instrument(s)”...
  • Page 10 Service Manual GEN04...

  • Page 11: Chapter 3 - Theory Of Operation

    Chapter 3 - Theory of Operation The H ™ Generator 300 System consists of the following components: Generator (GEN04), ARMONIC hand piece, instruments, foot switch, and hand switching adaptor (if used). The generator produces an electric signal, which is transmitted via a coaxial cable to the hand piece, which then converts the electrical signal into ultrasonic, mechanical motion.
  • Page 12 Service Manual Fig. 3-1 Block Diagram GEN04...

  • Page 13: Chapter 4 - System Setup

    Chapter 4 - System Setup Unpacking Instructions The H ™ Generator 300 System includes several components that are purchased separately. Upon ARMONIC receiving the ordered components, check for visible shipping damage. Do not attempt to use any component if it appears damaged. If damage is seen, contact your Ethicon Endo-Surgery representative. Note: The original packaging should be saved for future storing and/or transporting of the device.
  • Page 14 Service Manual 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 (Refer to Chapter 14 –...
  • Page 15 Chapter 4 - System Setup Turn the generator power switch on and observe the power-up sequence. During power-up, the following indicators on the front panel will briefly illuminate: • READY, STANDBY, MIN, MAX, TEST, ATTENTION, HAND ACTIVATION The system will run its start-up sequence and display the software version. An audible tone will sound during the initiation sequence.
  • Page 16 Service Manual GEN04...

  • Page 17: Chapter 5 - Operation

    Chapter 5 - Operation Controls, Indicators, and Connections Fig. 5-1 Front Panel When this indicator is green, the system is ready for activation. READY Note: In the Ready mode, for self-diagnostic purposes, the system sends a low-amplitude signal to the blade, causing the blade to vibrate slightly. This vibration does not pose a risk to the user.
  • Page 18 Service Manual 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 19: Screen Descriptions

    Chapter 5 - Operation Screen Descriptions Power-Up Screen Below is an example of the Software Version displayed during power-up. Fig. 5-3 Power-Up Screen Tone Selection Screen Refer to Chapter 15 – Adjustments for descriptions of the Tone Selection Screens. User-Initiated and Pre-Activation Test Screens The generator will cycle between the following two screens, displaying each screen briefly, for the duration of the time that the system is in the User-Initiated Test state and Pre-Activation Test state.
  • Page 20 Service Manual The following are all possible screens for the Standby, Ready, and Run states in Normal mode. The number on the left indicates the power level for MIN activation (1 to 5), and the number on the right is the power level for MAX activation.

  • Page 21: System Operation

    Chapter 5 - Operation System Operation For an understanding of system operation, refer to the H ™ Generator 300 System Operator’s ARMONIC Manual for instructions and specifications for use of the H ™ Generator 300 System, Foot Switch, ARMONIC and Cart. 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.

  • Page 22: System Shutdown

    Service Manual System Shutdown Turn the generator power switch off and remove power cord from outlet. Disconnect the hand piece, instrument, and adaptor or hand switching adaptor (if used) and process them as indicated in their respective package inserts. Clean the generator and cart and disinfect the foot switch(es) following hospital protocol (for recommendations, refer to Chapter 6 –...

  • Page 23: Chapter 6 - Cleaning And Disinfection

    Chapter 6 - 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.
  • Page 24 Service Manual GEN04...

  • Page 25: Chapter 7 - Safety And Function Testing

    Chapter 7 - Safety and Function Testing Test the 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.
  • Page 26 Service Manual GEN04...

  • Page 27: Chapter 8 - Generator Output Check

    Chapter 8 - Generator Output Check Procedure for Checking the output of GEN300 Generators Perform the functional test sequence of steps contained in the service manual, Chapter 7 – Safety and Function Testing (page 23). Then check the generator’s current output: Power the generator off.
  • Page 28 Service Manual GEN04...

  • Page 29: Chapter 9 - High-Level System Troubleshooting

    Chapter 9 - High-Level System Troubleshooting The H ™ Generator 300 System supports a series of audible and visual alarms, as well as error codes ARMONIC displayed on the unit’s LCD, to help in the identification and troubleshooting of problems down to the assembly level (i.e.

  • Page 30: Error Codes And Displays In Normal Operating Mode

    Service Manual Prolonged solid tone during Hand piece and/or blade fault. Press TEST to identify source of fault. activation (exceeds 10 seconds) Alarm (two-tone sequence) A component or system problem has occurred. Refer to the Error Codes section in this chapter or the Troubleshooting Guide. Note: This alarm will activate for three seconds, then will silence itself for 30 seconds.
  • Page 31 Chapter 9 - High-Level System Troubleshooting Error Code 2: Generator Error Code 2 indicates that the generator is overheating. Temperature Power off system. Remove any obstructions blocking the air vents on the generator’s bottom and back panels. If there is no apparent obstruction or external heat source, contact service.
  • Page 32 Service Manual Error Code 3 indicates a problem with the hand piece. Error Code 3: Hand Piece Confirm that the hand piece connector is fully inserted and properly oriented – white dot on hand piece is aligned with white dot on front panel. If the error code does not clear within three seconds after the hand piece is properly connected, press TEST.
  • Page 33 Chapter 9 - High-Level System Troubleshooting Error Code 4 indicates that the hand piece has exceeded its Error Code 4: Hand Piece Temperature specified operating temperature. For immediate recovery, use another hand piece; or, follow the steps below to determine the cause of the error condition and alternate recovery methods.
  • Page 34 Service Manual If the hand piece does not show evidence of overheating and troubleshooting steps 1-4 above do not appear to resolve the problem, perform the following: a. Leave the hand piece at room temperature for 24 hours or more. b.
  • Page 35 Chapter 9 - High-Level System Troubleshooting Note: As the hand piece ages, the generator performs measurements and updates a key hand piece parameter. This function is performed when the internal temperature of the hand piece is stable at room temperature. Certain usage patterns may prevent this update from occurring and subsequently make the hand piece diagnostics more sensitive to temperature.
  • Page 36 Service Manual If the error persists, install a test tip to isolate the problem. Press TEST button. • If system indicates a hand piece error, hand piece is bad or test tip is bad. Replace hand piece or install a new test tip and press TEST.
  • Page 37 Chapter 9 - High-Level System Troubleshooting Error Code 6: Foot Switch Error Code 6 indicates a foot switch pedal is stuck in the ON position. Confirm generator receptacle, foot switch receptacles and cable connectors are clean and dry or replace the foot switch. Note: If the error persists, replace foot switch.
  • Page 38 Service Manual Error Code 7: Hand Switch Error Code 7 indicates the hand switch is stuck in the ON position. Confirm contacts in the distal end of hand piece and in the proximal end of the hand switching adaptor are dry or replace the hand switching adaptor.

  • Page 39: Chapter 10 - Hand Piece Checkout

    Chapter 10 - Hand Piece Checkout Procedure for checkout/screening of HP054 Hand Pieces Note: You must use a calibrated Harmonic GEN 300 for testing hand pieces. Perform the functional test sequence of steps contained in the service manual, Chapter 7 – Safety and Function Testing (page 23).
  • Page 40 Service Manual Record the value of |Zr| - |Zr| is the value of the hand piece impedance as measured by the generator, and for a good hand piece and test tip, this value should be between 15 and 46 Ohms. Note: As the hand piece ages, the |Zr| value increases;...

  • Page 41: Chapter 11 - Advanced Error Codes

    Chapter 11 - Advanced Error Codes Error Code Display Generators with software version 1.09 and previous contain an error code display as a troubleshooting aid for Biomedical Engineers or technicians. The error codes can be accessed by pressing the Standby and "MIN Power-down"...

  • Page 42: Software Version

    Service Manual Software Version 1.09 Enhanced Display Functionality Software version 1.09 adds some enhancements to the displayed information over previous versions of software (Fig.11-1): • Momentarily Displays Hand Piece usage during Power-up (normal mode); 65530 - displayed number = APPROXIMATELY the number of procedures that have been performed with the current (connected) hand piece.

  • Page 43: Generator Error Log Record

    Chapter 11 - Advanced Error Codes Generator Error Log Record Hand Piece S/N Description of error Error time tag (On connector) Fig. 11-2 Software Version 1.09 Display Hand Piece Error Log Record Hand Piece S/N Description of error (On connector) Fig.
  • Page 44 Service Manual GEN04...

  • Page 45: Chapter 12 - Hardware Troubleshooting

    Chapter 12 - Hardware Troubleshooting The procedures described on the following pages require the generator to be powered up while the cover is removed. Caution should be taken to avoid making direct contact with any of the internal components while the unit is powered up. Warning: The AC mains voltage presents a shock hazard and is accessible when the generator cover is removed.
  • Page 46 Service Manual Front Bezel Power Supply Filter/Power Entry Module Generator Board Fig. 12-2 Front Bezel, Power Supply, Generator Board, and EMI Filter/Power Entry Module Fuse F2 Fuse F1 Sense Diode (D1) TP102 R233/R234 J8 J5 Fig. 12-3 Generator Board Component Locations GEN04...

  • Page 47: Common Failures

    Chapter 12 - Hardware Troubleshooting Generator Components The following illustrations identify the components examined during troubleshooting. Common Failures The following sections describe some of the most common failures associated with the high-level parts of the Harmonic Scalpel Generator. There is no guarantee that this document will be able to address every possible failure; for issues other than those described below, please call 1-800-USE-ENDO for further assistance.
  • Page 48 Service Manual 12-3 • Unit shuts down immediately after turning on power switch. This is an indication of an internal short that is causing the 48 VDC Power Supply to enter overload protection. Refer to Chapter 12 – Hardware Troubleshooting (Figure 12-8, page 51) to determine if there is a short and where the short is located.

  • Page 49: Procedures

    Chapter 12 - Hardware Troubleshooting Procedures The following sections contain flowcharts that outline procedures to help determine whether the problem that is occurring is due to a high-level component failure or a failure associated with the Generator Board. Before executing any of these procedures, remove the Generator’s cover, attach a known good instrument or test tip and power the unit up.
  • Page 50 Service Manual Power Supply Fig. 12-5 Power Supply Troubleshooting Flowchart GEN04...
  • Page 51 Chapter 12 - Hardware Troubleshooting LCD Display Fig. 12-6 LCD Display Troubleshooting Flowchart GEN04...
  • Page 52 Service Manual Front Bezel Fig. 12-7 Front Bezel Troubleshooting Flowchart GEN04...
  • Page 53 Chapter 12 - Hardware Troubleshooting Unit Short Test Fig. 12-8 Unit Short Test Troubleshooting Flowchart GEN04...
  • Page 54 Service Manual Unit Short Test Fig. 12-9 Unit Short Test Troubleshooting Flowchart (Cont.) GEN04...
  • Page 55 Chapter 12 - Hardware Troubleshooting Cooling Fan Fig. 12-10 Cooling Fan Troubleshooting Flowchart GEN04...
  • Page 56 Service Manual Footswitch Activation Footswitch Activation Troubleshooting Footswitch activation is not functioning properly Check Is the “Ready Check Voltages at Resistances Resistances at J12 correct at J12 LED” on the J12 or J13 on and J13 on PCB- and J13? See front panel lit? PCB- see Note 2.
  • Page 57 Chapter 12 - Hardware Troubleshooting Handswitch Activation Generator Main PCB Generator Front Panel 33.2 Ohm Handpiece Connector Receptacle Yellow Wire Orange Wire 33.2 Ohm Outer Gold Ring Inner Gold Ring Fig. 12-12 Handswitch Activation Troubleshooting Flowchart GEN04...
  • Page 58 Service Manual GEN04...

  • Page 59: Chapter 13 - Generator Calibration

    Chapter 13 - Generator Calibration Required Schedule Calibration is required on the U Generator 300 every twelve months. LTRA ISION ARMONIC CALPEL Proof of calibration should be documented according to hospital procedures. Generators can be returned to Ethicon Endo-Surgery, Inc. for calibration, but this is not covered in the warranty.
  • Page 60 Service Manual Scroll to page 2. Record the ‘Current Setpoint’ value: _______________mA By specification, 75% of the value recorded in step 7 is the Anticipated Level 3 current. Calculate and record this value by multiplying the step 7 value above, by 0.75. _______________mA Scroll to page 17.

  • Page 61: Calibration Two

    Chapter 13 - Generator Calibration Calibration Two (Read Current Calibration) This section describes the requirements for calibrating the monitored (read) current level of the GEN04 Generator. Note: “Power up into BME Mode” includes taking the following steps – which are also contained in the service manual (included here for reference): •...
  • Page 62 Service Manual GEN04...

  • Page 63: Chapter 14 - System Specifications

    Chapter 14 - System Specifications Product Codes Required Components for System Operation: GEN04: Generator 300 HP054/HP055: Hand Piece (includes HST02 Test Tip and TLB01 Torque 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.
  • Page 64 Service 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 65 Chapter 14 - System Specifications Torque Requirements Item Torque Units Thread Comments Locker Front Bezel,Volume Control In-Lb long socket required Front Bezel, Hand Piece In-Lb torqued with open-end Receptacle torque wrench Front Bezel, LCD In-Oz Phillips, Loctite 222 Front Bezel to Chassis In-Lb Phillips Fan to Chassis...
  • Page 66 Service Manual GEN04...

  • Page 67: Chapter 15 - Adjustments

    Chapter 15 - Adjustments Power Level Adjustment Upon start-up, 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 arrow button to the left of the MIN power level display.
  • Page 68 Service Manual GEN04...

  • Page 69: Chapter 16 - Service And Repair

    Chapter 16 - Service and Repair Repair Strategy • Thorough knowledge of the H ™ Generator 300 System User Manual and this manual is ARMONIC mandatory prior to attempting any repair. • Loaner units may be provided free of charge for units which are being repaired under warranty. •...

  • Page 70: Available Resources

    Service Manual 700-001666 Hardware, Lockwasher, for Hand Piece 700-001667 Hardware, Grommet 700-001668 Hardware, Bushing (Wire Protectors) 700-001749 Hardware, Phillips 6 – 32 x 5/16 700-001767 Hardware, Hnut 3/4 – 16 x 7, 8 x 5/32 800-003007 Power Entry Module 875-000358 Power Supply, 48 Volt 950-000443 Packaging, Bag, Anti-Static 24 x 30;...

  • Page 71: Chapter 17 - Warranty

    Chapter 17 - Warranty This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Ohio, U.S.A. Ethicon Endo-Surgery warrants this product to be free from defects in material and workmanship under nor- mal use and preventive maintenance for the respective warranty period shown below.
  • Page 72 Service Manual GEN04...

  • Page 73: Chapter 18 - Symbols

    Chapter 18 - Symbols Fuse Safe working load Type CF Applied Part Test Hand Activation Temperature Volume Relative Humidity Minimum Attention - Consult Accompanying Maximum Documents/See Instructions For Use Non-Sterile Ready Date of Manufacture Standby Fragile Reorder Number Caution: Federal (USA) law restricts this This end up device to sale by or on the order of a physician.
  • Page 74 Service Manual Authorized Representative in the European Community. Authorized Representative in the USA. Electrical and electronic equipment. Return waste to a collection system or treatment and recycling facilities. Applicable in the EU. Follow decontamination instructions before returning waste. GEN04...

  • Page 75: Appendix A - Mains Power Wiring Diagram

    Appendix A - Mains Power Wiring Diagram GEN04...
  • Page 76 Service Manual GEN04...

  • Page 77: Appendix B - Gen04 Assembly Diagram

    Appendix B - GEN04 Main Assembly Drawing GEN04...
  • Page 78 Service Manual Parts List The reference numbers below correspond to reference numbers on the Main Assembly Drawing on the previous page. Reference No. Part No. Description D06358P01 Fuse Label D06363P01 Back Panel Label 3583.036 Bezel Sub-Assembly 3583.180 Cover Enclosure 3583.053 Cable Assembly, Hand Piece Receptacle 3583.060 Cable Assembly, Earth Terminal –...

  • Page 79: Appendix C - Gen04 Top Level Diagram

    Appendix C - GEN04 Top Level Diagram GEN04...
  • Page 80 GEN04 Ethicon Endo-Surgery (Europe) GmbH Hummelsbuetteler Steindamm 71 22851 Norderstedt GERMANY Johnson & Johnson AG CH-8957 Spreitenbach SWITZERLAND Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242-2839 USA 1-800-USE-ENDO P40401P03...

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Ethicon endo-surgery harmonic generator 300

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