HARMONIC GENERATOR 300 User manual

HARMONIC® GENERATOR 300

Advanced Troubleshooting Guide

Transforming Patient Care Through Innovation™

This Troubleshooting Guide will help you to support

the HARMONIC

Whenever a problem occurs on the HARMONIC

Generator 300 system.

Generator 300

system, refer to the specific section listed on the index page.

Should you still have trouble pinpointing the issue after

consulting the respective section, contact us at

1-800-USE-ENDO

Note that this manual may be subject to revisions.

Please ensure that you are referring to

the latest version.

The Advanced Troubleshooting Guide is intended as an adjunct to the instructions for use.

Before using the device, read full instructions for use.

GEN04 Harmonic® Generator 300

HP054 Hand Piece

HPBLUE Hand Piece

1 HARMONIC® GENERATOR 300.........................................................................................5

1.1 Generator Power-Up Problems .................................................................................5

1.2 Audible Indicators and Alarms...................................................................................6

1.3 Main Error Codes and Displays..................................................................................7

1.4 Error Code 1: Generator ............................................................................................8

1.5 Error Code 2: Generator Temperature .......................................................................9

1.6 Error Code 3: Hand Piece ........................................................................................10

1.7 Error Code 4: Hand Piece Temperature...................................................................12

1.8 Error Code 5: Instrument.........................................................................................16

1.9 Error Code 6: Foot Switch.......................................................................................17

1.10 Error Code 7: Hand Switch......................................................................................18

1.11 Generator Testing: Function Test............................................................................19

1.12 Service Mode for Generator Testing........................................................................21

1.13 Generator 300 Test in BME Mode...........................................................................22

1.14 GEN04 Calibration Procedure...................................................................................26

1.14.1 Calibration One Procedure..................................................................................27

1.14.2 Calibration Two Procedure................................................................................30

1.15 Error Display Mode (SW 1.09)..............................................................................33

1.16 Specific Error Codes...................................................................................................34

2 HARMONIC

Hand Piece HP054.....................................................................................36

2.1 Screening of Hand Piece HP054...............................................................................37

2.2 Service Mode for Hand Piece Testing......................................................................38

2.3 Record the value HP Procedures.............................................................................39

2.4 Record the value pf PM (Phase Margin).....................................................................40

2.5 Record the value of |Zr| (Impedance).........................................................................41

2.6 Record the value of Error Display Mode (SW 1.09)...................................................42

3 HARMONIC

Hand Piece HPBlue....................................................................................43

3.1 Screening of Hand Piece HPBlue...............................................................................44

3.2 Service Mode for Hand Piece Testing......................................................................45

3.3 Record the value HP Procedures.............................................................................46

3.4 Record the value pf PM (Phase Margin).....................................................................47

3.5 Record the value of |Zrl (Impedance).........................................................................48

3.6 Record the value of Error Display Mode (SW 1.09)...................................................49

1 HARMONIC

GENERATOR 300

The HARMONIC audible and visual alarms, as well as error codes displayed on the unit’s LCD, to help in identifying and troubleshooting

Generator 300 System supports a series of

problems. This guide is meant as an adjunct to, but not a substitute for, clinical judgment and observations. If the problem cannot be resolved using the corrective actions contained within this troubleshooting guide, contact 1-800-USE-ENDO. Please have the model number, serial number from the rear panel of the generator, and a detailed description of the problem. The description of the problem should include power settings, accessories used, procedure being performed, and software version of the unit.

1.1 Generator Power-Up Problems

Ensure the generator unit is plugged into a functioning wall outlet and that the power cord is attached to the rear panel of the generator. If the unit still does not respond, have a biomedical engineer verify that the fuses are intact and properly installed.

Note: There are both external and internal fuses in the generator unit. Refer to the Replacement Parts drawings in the back of the system service manual for fuse locations.

1.2 Audible Indicators and Alarms

Tone Possible Cause and Corrective Action

No tone during power-up.

No tone when system is activated

Activation (brief pulses)

Alert (three-tone sequence)

Constant tone

Prolonged solid tone during activation (10s)

Alarm (two-tone sequence)

Generator failure. Contact 1-800-USE-ENDO.

• Confirm hand activation is enabled if hand-

switching adaptor or hand activation is being used.

• Confirm foot switch is fully connected (if hand

switching adaptor or hand activation is not being used).

• Confirm foot switch is not faulty.

• If hand-switching adaptor is used, confirm it is

connected and not faulty. System is being activated or is in Test mode.

System is operating properly. MIN and MAX power have unique tones.

• Activation is attempted while generator is in

Standby mode. Push the STANDBY button to return the generator to Ready mode.

• Two or more foot or hand activation switches are

recognized by the generator as being activated simultaneously. Release all activation switches and reactivate using only one switch.

1. Instrument is in contact 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.

• Hand piece and/or blade fault. Press TEST to

identify source of fault.

• A component or system problem has occurred.

Refer to the Error Codes section Guide.

Note: This alarm will activate for three seconds, then will silence itself for 30 seconds. This cycle will continue until the error is resolved or the main power switch is turned off.

1.3 Main Error Codes and Displays

The generator will recognize specific faults in five areas: generator, hand piece, instrument, foot switch or hand switch. When a fault is identified, an alarm will sound, the error number 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).

Note: For each error code, the generator will cycle between each of the two screens shown in the examples below, with the faulty component flashing.

Follow the procedures outlined within this troubleshooting guide (or in the Troubleshooting Guide on the top of the generator unit) to resolve the problem.

1.4 Error Code 1: Generator

Generator Error Code 1 indicates that 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 the system off and contact 1-800-USE-ENDO.

Fig. 1 Generator failure screen

1.5 Error Code 2: Generator Temperature

Error Code 2 indicates that the generator is overheating.

1. Power the system off. 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 1-800-USE-ENDO.

2. Power on the system and wait for up to 30 minutes for the

generator error to clear.

3. If the error code persists, contact 1-800-USE-ENDO.

Fig. 2 Generator over temperature screen

1.6 Error Code 3: Hand Piece

Error Code 3 indicates a problem with the hand piece. Please also refer to “HP054” or “HPBLUE” hand piece section.

1. Confirm 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.

2. The instrument may not be tightened properly or tissue may

have collected in the distal end of the instrument shaft. Tighten instrument using torque 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: For HP054: Inspect the torque wrench hub for cracks or wear before use. If damage is seen, replace the blade wrench. Before using 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. Please loosen the instruments with the blade wrench.

3. 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.

• If no error occurs with test tip attached, replace instrument.

• Press STANDBY to return to Ready mode. Activate system.

Fig. 3 Hand Piece generic error screen

1.7 Error Code 4: Hand Piece Temperature

Error Code 4 indicates that the hand piece has exceeded its specified operating temperature. This error code pertains to the HP054 only.

For immediate recovery use another hand piece, or follow the steps below to determine the cause of the error condition and recovery methods.

The following are possible causes of an increase in hand piece temperature. To correct this condition, complete the appropriate steps below and

before resuming operation

1. The hand piece is still warm from recent steam sterilization.

Allow the hand piece to cool at room temperature for at least 45 minutes

Note: The hand-switching adaptor (HSA07) should not be submerged for rapid cooling purposes. This may render the hand switching adaptor inoperable for an extended period of time. After steam sterilization, allow the hand switching adaptor to air cool at least 15 minutes prior to use.

allow the hand piece to cool

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.

• If no error occurs with test tip attached, replace

instrument.

3. Press STANDBY to return to Ready mode. Activate system.

4. If the hand piece does not show evidence of overheating

and troubleshooting steps 1-3 do not appear to resolve the problem, perform the following:

• Leave the hand piece at room temperature for 24 hours

or more.

• Remove any test tip or instrument from the hand piece.

• With the generator turned off, plug the hand piece into

any Generator 300.

• Power up the generator in Biomed mode while pressing

and holding down the STANDBY button and down arrow.

• Wait for a steady display – approximately 10 seconds.

• If a “Generator” error occurs one of the buttons was

not properly held down. If this happens repeat the power up procedure in Biomed mode.

• If necessary, press the STANDBY button until it illuminates.

• Use the up and down arrows 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 activate the MIN or MAX activation buttons on the foot switch or hand switch if either is attached.

• After 30 or more minutes, press the STANDBY button

until the STANDBY icon is illuminated.

• Again, read the “XDUCER CAPACITANCE” on Page 2 of 21.

• If the number has changed, the update was successful.

• If the number has not changed, then this update

attempt did not succeed. Power down the generator and repeat this procedure.

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. The steps above will cause an update of the hand piece parameter and return the system to designed sensitivity.

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.

Warning: To avoid user or patient injury, ensure that the instrument is clear of the patient, other instruments, drapes, or other objects before pressing TEST. Safety measures (in accordance with hospital protocol) taken in the presence of aerosols should be in effect while in Test mode.

Fig. 4 Hand Piece over temperature error screen

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HARMONIC GENERATOR 300 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual