Johnson & Johnson ETHICON ENDO-SURGERY HARMONIC 300, Service Manual

Page 1: ...HARMONIC Generator 300 System Service Manual ...

Page 2: ...GEN04 ...

Page 3: ...nitial Setup 11 Chapter 5 Operation 15 Controls Indicators and Connections 15 Screen Descriptions 17 System Operation 19 System Shutdown 20 Chapter 6 Cleaning and Disinfection 21 Generator and Cart Cleaning 21 Foot Switch Cleaning 21 Chapter 7 Safety and Function Testing 23 Safety Test 23 Function Test 23 Chapter 8 Generator Output Check 25 Procedure for Checking the Output of GEN300 Generators 25...

Page 4: ...ration 57 Required Schedule 57 Calibration Procedures 57 Calibration One 57 Calibration Two 59 Chapter 14 System Specifications 61 Chapter 15 Adjustments 65 Power Level Adjustment 65 Audible Activation Tone Adjustment 65 Chapter 16 Service and Repair 67 Repair Strategy 67 Spare Parts List 67 Available Resources 68 Service and Repair Returns 68 Chapter 17 Warranty 69 Chapter 18 Symbols 71 Appendix ...

Page 5: ...tallation Ethicon Endo Surgery reserves the right to change the electrical electronic or mechanical configurations and components without notice Schematic revisions may not match PCB revisions in the unit being maintained consult Ethicon Endo Surgery before making any changes When necessary amendments to this manual will be made available by request only Product Information Product Name HARMONIC G...

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Page 7: ...tor unit may expose the user to parts within the generator unit which may have high surface temperatures and high voltage These surfaces are potentially dangerous and should be treated with extreme caution Always unplug the generator from the wall outlet prior to opening the cover for servicing This poses a potential electric shock hazard After removing the cover inspect the internal components fo...

Page 8: ... to flow freely through the generator enclosure Avoid placing the generator on a soft surface Use proper electrical safety and hospital procedures when working on the generator unit The AC mains voltage presents a shock hazard and is accessible when the generator cover is removed Caution must be used near internal system components which attach directly to the AC mains such as the power entry modu...

Page 9: ...ts Generator 300 The generator supplies the hand piece with electrical energy and facilitates selection of power levels system monitoring and system diagnostics Power is delivered by activating the foot switch or hand switching adaptor Hand Piece The hand piece contains an acoustic transducer that converts the electrical energy supplied by the generator to mechanical motion The transducer is conne...

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Page 11: ...al grade utility cord Refer to Chapter 14 System Specifications for details Provides susceptibility filtering from the external environment as well as suppressing electromagnetic emissions produced by the generator that could be conducted back through the power cord Power Supply Provides 48 VDC to DC DC Converter and Current Power Regulation Circuit Current and Power Regulation Circuit Provides Cu...

Page 12: ...d Front Panel Indicators Front Panel Switches Audio Power Supply Microprocessor Current and Power Regulation Circuit Drive Frequency Circuit Power Amplifier Current Limit Circuit Current Feedback Circuit Voltage Feedback Circuit Hand Activation Circuit Patient Isolation Circuit Hand Piece and Hand Switching Adaptor ...

Page 13: ... instruments that are not compatible with the hand switching adaptor Since the generator has receptacles for two foot switches two foot switches may have been shipped Cart the cart is optional It is designed to hold one HARMONIC Generator 300 unit The cart requires assembly instructions are included with the cart Initial Setup 1 Confirm that the generator power switch is OFF during setup Caution T...

Page 14: ...ight Ensure the collar is finger tight to prevent inadvertent activation that may result from fluid ingress b Connect the foot switch cable s smaller connector to the foot switch receptacle on the rear panel of the generator Confirm that the connector and receptacle are dry and clean Align the red dot on the foot switch 4 pin connector with the red dot on the 4 pin receptacle on the generator back...

Page 15: ...ire power up initiation sequence should not exceed ten seconds If the start up sequence deviates from the description above contact qualified service personnel following hospital protocol When the initiation sequence is complete the system will go to Standby 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 ala...

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Page 17: ... desired level from 1 to 5 The level chosen will be shown LEVEL on the graphic display The power level 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 MIN ...

Page 18: ...oblem exists error codes will appear on this display Fig 5 2 Back Panel 13 FOOT SWITCH Identical receptacles allow connection of up to two foot switch RECEPTACLES assemblies for 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 Refer to the Rep...

Page 19: ...nd Function Testing for details Fig 5 4 Test in Progress Screens Standby Ready and Run Screens The Standby Ready and Run screen appearances depend on the mode in which the system is running In Normal mode the Standby Ready and Run screens are the same and indicate the MAX power level of 5 on the right and the user selected MIN power level on the left 1 to 5 In Developer Biomed mode the Standby scr...

Page 20: ...mal 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 Fig 5 5 Standby Ready and Run Screens in Normal Mode Error Screens Refer to Chapter 9 High Level System Troubleshooting for examples of each of these screens ...

Page 21: ...ppear refer to Chapter 9 High Level System Troubleshooting or the Troubleshooting Guide located on top of the generator unit 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 ...

Page 22: ...d 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 6 Cleaning and Disinfection 4 Store foot switch es on the cart shelves provided Each shelf will hold one foot switch 5 Wrap foot switch cable s and the power cord on the cart s back handle for storage ...

Page 23: ... using a soft clean cloth lightly moistened with 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 swi...

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Page 25: ...crease Power Level button up and down to confirm the MIN Power Level changes 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 Press the TEST button to perform a User Initiated Test The system will run a series of tests...

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Page 27: ... Expected Output Current _____________________________ g Press the Standby key to enter Ready state h Activate at level 5 by pressing the max foot switch pedal or max switch on the hand switching adapter while keeping the test tip in air i Allow the pre run test to complete Terminate activation after regular max activation beeps are audible j Record the current on the display while continuing to a...

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Page 29: ...or foreign debris Never power ON a damaged unit Audible Indicators and Alarms Tone Possible Cause and Corrective Action No tone during power up Generator failure Contact service personnel No tone when system is activated Confirm that the foot switch is fully connected if hand switching adap tor is not being used Confirm foot switch is not faulty If hand switching adaptor is used confirm it is conn...

Page 30: ... switch or hand switch When a fault is identified an alarm will sound the alarm indicator will appear on the generator control panel and the source of the problem will appear on the graphic display the power levels will not be displayed If an error code is displayed follow the procedures outlined below or in the Troubleshooting Guide on the top of the generator unit to resolve the problem Note For...

Page 31: ...wer 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 2 Power on the system and wait for up to 30 minutes for generator error to clear 3 If error code persists contact service Fig 9 2 Generator Over Temperature Error Screens ...

Page 32: ...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 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 ...

Page 33: ...rilization allow the hand switching adaptor to air cool at least 15 minutes prior to use 2 The instrument may not be tightened properly or tissue may 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 ...

Page 34: ...wer up procedure in Biomed mode 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 Leave the hand piece plugged into the generator Do not remove hand piece during entire procedure Do not ac...

Page 35: ... Do not run the Test mode while an electrosurgical generator is being activated in the room Interference from the electrosurgical generator may affect test results Fig 9 4 Hand Piece Over Temperature Error Screens Error Code 5 Instrument Error Code 5 indicates a problem with the instrument 1 The instrument may not be tightened properly or tissue may have collected in the distal end of the instrume...

Page 36: ...ade 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 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 o...

Page 37: ...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 Fig 9 6 Foot Switch Assembly Error Screens ...

Page 38: ...nd 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 Note If the error persists replace hand switch Fig 9 7 Hand Activation Assembly Error Screens ...

Page 39: ...ing the TEST button If an error is detected the hand piece is defective and subsequent testing is not required 7 Perform the following while the generator is in Standby a On BME display pg 1 i Record the value of HP Procedures the estimated number of procedures the hand piece has been used in In order to record the number perform the following calculation 65530 minus the listed on the display The ...

Page 40: ... standby button to place generator in Ready State 9 Activate at level 5 until the pre run test is complete 10 Stop activation after pre run test completes 11 Reactivate at level 5 12 Record the value of impedance on the display while continuing to activating at level 5 Impedance _______________________________________________ Note As the hand piece ages the impedance value increases therefore if t...

Page 41: ...ESENT_NO_FET_BIAS_FAULT 3 Handpiece 3D OFF RES C0 nMEAS FAULT HP_OFFRES_C0_MEASUREMENT_FAULT 3 Handpiece 4C PRE RUN TRANS nVERSAL 324 HP_PRE_RUN_TRANSVERSAL_324 3 Handpiece 4D HIGH C0 RATE OF nCHANGE 293 HP_HIGH_C0_RATE_OF_CHANGE_293 3 Handpiece 4E HP END OF LIFE n 292 HP_END_OF_LIFE_292 3 Handpiece 4F BAD HP WITH nTEST TIP 258 BAD_HP_W_TEST_TIP_FAULT_258 3 Handpiece 50 UNSTABLE OUTPUT nHP OPEN FA...

Page 42: ...o specific technical issues is identical to the Hex code display but with these added enhancements for each error code Error Code Time Stamp Error Code Text Description If hand piece related the Lot Number and Transducer Number of the hand piece that was being used is displayed Caution Make sure to press BOTH buttons simultaneously otherwise Generator Error code 1 will show up which will require t...

Page 43: ...ription of error Hand Piece S N On connector Error time tag Description of error Hand Piece S N On connector Fig 11 2 Software Version 1 09 Display Fig 11 3 Software Version 1 09 Display Cont Hand Piece Error Log Record Generator Error Log Record ...

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Page 45: ...ents a shock hazard and is accessible when the generator cover is removed Caution must be used near internal system components which attach directly to the AC mains such as the power entry module mains fuses power switch and open frame 48V power supply Test Equipment and Tools High level troubleshooting of the Harmonic Scalpel Generator requires the following tools Digital Multi meter Phillips scr...

Page 46: ... Power Entry Module Front Bezel Generator Board Fig 12 2 Front Bezel Power Supply Generator Board and EMI Filter Power Entry Module Fig 12 3 Generator Board Component Locations Fuse F2 J6 Sense Diode D1 R233 R234 J2 J3 J8 J5 J4 J16 J11 Fuse F1 TP102 ...

Page 47: ...t to EES Service 9E AUD_TIMEOUT_FAILURE Replace Generator Board or Send Unit to EES Service 9F WATCHDOG_FAILURE Replace Generator Board or Send Unit to EES Service A0 NMI_ISR_FAILURE Replace Generator Board or Send Unit to EES Service A1 PHANTOM_ISR_FAILURE Replace Generator Board or Send Unit to EES Service A2 ROM_CRC_FAILURE Replace Generator Board or Send Unit to EES Service A3 DATA_MEM_FAILURE...

Page 48: ...characters If random characters are displayed immediately upon the unit being powered up yet the display clears and the unit functions properly replace the Generator Board For all other issues see Chapter 12 Hardware Troubleshooting Figure 12 6 page 49 12 7 Buttons on the Front Bezel are not responding If the unit does not respond to button depressions on the front bezel refer to Chapter 12 Hardwa...

Page 49: ...Receptacle Continuity Test 1 Power down the unit and remove the power cord 2 Disconnect the wire harnesses from connectors J3 and J4 3 Measuring between the Hand Piece Receptacle on the front panel and the Generator Board wire harness connectors test the continuity of each of the wires according to the pinout table below use Figure 12 4 as a reference PCB Connector Connector Wire Receptacle Pin J3...

Page 50: ...48 GEN04 Service Manual Power Supply Fig 12 5 Power Supply Troubleshooting Flowchart ...

Page 51: ...49 GEN04 Chapter 12 Hardware Troubleshooting LCD Display Fig 12 6 LCD Display Troubleshooting Flowchart ...

Page 52: ...50 GEN04 Service Manual Front Bezel Fig 12 7 Front Bezel Troubleshooting Flowchart ...

Page 53: ...51 GEN04 Chapter 12 Hardware Troubleshooting Unit Short Test Fig 12 8 Unit Short Test Troubleshooting Flowchart ...

Page 54: ...52 GEN04 Service Manual Unit Short Test Fig 12 9 Unit Short Test Troubleshooting Flowchart Cont ...

Page 55: ...53 GEN04 Chapter 12 Hardware Troubleshooting Cooling Fan Fig 12 10 Cooling Fan Troubleshooting Flowchart ...

Page 56: ...2 and J13 See Note 1 Below Footswitch connectors on back panel of Generator J12 on PCB Pin 1 Pin 2 Pin 3 Pin 4 J13 on PCB Pin 1 Pin 2 Pin 3 Pin 4 YES NO Check Voltages at J12 or J13 on PCB see Note 2 Note 2 Voltage Levels Between pins of J12 or J13 on PCB with footswitch connected unless otherwise noted a Between Pin 1 3 i 4VDC with MIN pedal not depressed or if footswitch not connected ii 0 5VDC ...

Page 57: ...ooting Handswitch Activation Inner Gold Ring 33 2 Ohm 33 2 Ohm Generator Front Panel Outer Gold Ring Generator Main PCB Handpiece Connector Receptacle J3 Yellow Wire Orange Wire 3 2 Fig 12 12 Handswitch Activation Troubleshooting Flowchart ...

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Page 59: ...ing order Calibration One Calibration Two Calibration One Write Current Calibration This section describes the requirements for calibrating the output current level of the generator Minimum Accuracy Requirements True RMS AC Voltage Voltage Range 100mV to 1000mV 23 C 5 C 3hz 5hz 1 00 of reading 0 04 of range 5hz 10hz 0 35 of reading 0 04 of range 10hz 20Khz 0 06 of reading 0 04 of range 20Khz 50 Kh...

Page 60: ...oot switch or hand switch button 17 Put the generator into BME Standby State by pressing the STANDBY Key 18 Scroll to page 17 19 By turning the volume knob dial in the value read on the DMM in step 16 a number is displayed on the LCD which changes as the knob is turned 20 Press the TEST key one time only one time Value Accepted should flash Fail_____ Pass_____ 21 Power off the unit for at least 5 ...

Page 61: ...er buttons 10 Put the generator into BME Standby State by pressing the STANDBY Key 11 Scroll to page 18 12 Press the TEST key one time only one time to accept the calibration current value 13 The text Value Accepted should flash if the calibration procedure was successful Fail_____ Pass_____ 14 Record the current displayed on the screen _______________mA 15 Power the unit off for at least 5 second...

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Page 63: ...witching adaptor is required to operate the generator When the hand switching adaptor 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 Degree of Protection Against Harmful Ingress of Water Generator Ordinary equipment Footswitch IPX8 Safety Classificat...

Page 64: ...rd set with the following characteristics Plug Style as needed 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 0 mm2 copper Voltage Rating 250 VAC minimum Wiring international Cordage Type HAR Item to have certification by at least one of the followin...

Page 65: ... Connectors to Chassis 11 In Lb No 2 long socket required Speaker to Chassis 11 In Lb No 4 Phillips Silver Ribbon Cable from 11 In Lb No 1 Phillips Front Panel Switches Fuse Holders to Chassis 6 In Lb No 2 long socket required Power Entry Module to Chassis 6 In Lb No 2 Phillips hold the nut Ground Pin to Chassis 6 In Lb No 1 Special tool used to engage nut Ground Pin Nut 18 In Lb No 1 standard soc...

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Page 67: ... 2 Switch power on Then immediately depress and hold both the STANDBY and HAND ACTIVATION buttons When the graphic shown in Fig 11 1 appears on the display release the STANDBY and HAND ACTIVATION buttons 3 While in the Tone Selection mode the generator will automatically sequence through the available tone pitches To select a tone depress any button on the control panel The generator will return t...

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Page 69: ...63P01 Back Panel Label 3 3583 036 Bezel Sub Assembly 4 3583 180 Cover Enclosure 5 3583 053 Cable Assembly Hand Piece Receptacle 6 3583 060 Cable Assembly Earth Terminal Chassis 7 3583 061 Cable Assembly Power Entry Chassis 8 3583 062 Cable Assembly Fuse Holder AC Switch 9 3583 064 Cable Assembly Volume Control Generator Board 10 3583 065 Cable Assembly Fan with Cable Assembly 11 3583 066 Cable Ass...

Page 70: ...lable for Biomedical engineering sup port by calling 1 800 USE ENDO U S Customers Customers outside the U S should contact their Ethicon Endo Surgery representative for assistance Service and Repair Returns U S All service inquiries in the US should be initiated by calling 1 800 USE ENDO A Customer Service representative will walk the customer through the equipment return process and identify the ...

Page 71: ...milar 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 Extended warranties available Call 1 800 USE ENDO for more information Carts One 1 Year Parts and Labor Foot Switches and Cables One 1 Year Parts and Labor S...

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Page 73: ...rease Serial Number Equipotential 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 1 Warnings and Precautions for additional specifications Foot switch Manufacturer Chapter...

Page 74: ...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 ...

Page 75: ...ator 300 L E N 1 2 Power Entry Module 2 3 Protective Earth Copnnection to Chassis 3 4 Mains Fuses 3 15A 250V IEC Type T 4 5 DPDT Mains Switch 5 6 48VDC Medical Grade Power Supply 6 7 Generator PCB 7 8 Isolated Transducer Drive Patient Connection 8 9 Isolation Barriers 9 9 COM 48 10 Functional Earth Connections to Chassis 10 10 ...

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Page 77: ...75 GEN04 Appendix B GEN04 Main Assembly Drawing ...

Page 78: ...Amps 250 Volts Slo Blo 21 640 000268 Ferrite Clamp Bracket 279 100MHz 22 700 001493 Hardware Nut 8 32 for fan assembly 23 700 000394 2 Hardware Phillips 8 32 x 5 16 for ground to chassis 24 700 000504 1 Hardware Phillips 4 40 x 3 8 25 700 000884 Hardware KNut 4 40 26 700 001497 Hardware Ground Pin 27 700 001653 Hardware Knob 28 700 001662 Hardware Feet Rubber Black with screw 29 700 001663 Hardwar...

Page 79: ...77 GEN04 Appendix C GEN04 Top Level Diagram Hand Piece ID Hand Piece Transducer ...

Page 80: ...con 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 ...