EnSeal RF60 Service Manual Rev A PDF download

EnSeal® RF60 Service Manual

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Table of Contents Chapter 1 - System Overview��5

Device Description��5 Indications��5 Contraindications��5 Warnings��5 Precautions��6 Abbreviations��6 How Supplied��6 Accessories��6 Setup��6 RF Indicators and Connectors��7 Initiation��7 Standby��7 Operation��7 RF Enabled��7 Self Test at RF On and Fault State��7 Replace Indicator��8 RF Power Delivery��8 Complete Indicator��8 Control Indicator��8 Footswitch or Handswitch Double-Tap Mode��8 Chapter 2 - RF60 Theory of Operation��9 Detailed Hardware Description��9 RF60 Generator Functionality Overview��9 RF60 Main PCB I/O Diagram��10 Main PCB I/O Diagram��10 Main PCB I/O Diagram Description��10 RF60 Main PCB Functional Block Diagram��12 Block Diagram��12 Block Diagram Description��13 Chapter 3 - Product Specifications��15 Conformance to Standards��15 Electromagnetic Compatibility (EMC), Guidance, and Manufacturer Declarations��15 Chapter 4 - Warranty and Technical Support��18 Warranty��18 Customer Service��19 Chapter 5 - Troubleshooting��19 Indicators / Error Codes��19 Chapter 6 - Repair and Replacement Procedures��20 Introduction��20 Removing the Enclosure Top��21 Removing and Replacing the Two Main Fuses��22 Removing and Replacing the Fan Assembly��23 Removing and Replacing the Power Entry Module��24 Removing and Replacing the Power Supply��25 Removing and Replacing the Main PCB Board��26 Removing and Replacing Footswitch Receptacle��27 Removing and Replacing the EnSeal® Connector��28 Removing and Replacing RF60 Overlay��29 Replacing the Bottom Enclosure��30 Chapter 7 - Preventive Maintenance��31 Electrical Safety Checks��31 General Electrical Safety Testing Parameters��31 Cleaning and Disinfection��31

Table of Contents Chapter 8 - Functional Test RF60 Generator��32

Startup Check��32 Power Output Functional Check��32 Test Equipment Needed��34 Power Output Functional Check��34 Impedance Measurement Functional Check��39 Fault Test – Functional Check��40 Hand Activation Functional Check��41 Double Tap Mode with Footswitch Functional Check��41 Double Tap Mode with Hand Activation Instrument Functional Check��41 Simulate a Hand Activation Device with Limit Switch Functional Check��41 Simulate a Hand switch Cutoff when Footswitch is Pressed, Functional Check��44 Simulate a Hand switch Cutoff when Footswitch is Pressed, Functional Check (with complete LED)��44 Sample Form RF60 Functional Test Results��46 Chapter 9 - Assembly Diagram and Spare Parts List��48 Main Assembly Diagram��48 Spare Parts List��49 Chapter 10 - Schematic Diagrams��50 Schematic, RF60 Main PCB Page No. 1��50 Schematic, RF60 Main PCB Page No. 2��51 Schematic, RF60 Main PCB Page No. 3��52 Schematic, RF60 Main PCB Page No. 4��53 Handswitch Detection Board Page No. 1��54 RF60 Main PCB & Handswitch Detection PCB Connector & Test Point Details��55 Chapter 11 - Symbols ��57

RF60 Service Manual Chapter 1 - System Overview Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Important: This manual is designed to provide service and repair instructions for the ENSEAL® RF60 Generator. It is not a reference to surgical techniques. ENSEAL® and I-BLADE® are trademarks of Ethicon Endo-Surgery. Device Description The ENSEAL® RF60 Generator is a microprocessor controlled bipolar electrosurgical radiofrequency (RF) generator with a quasi-sinusoidal forced impedance output. The ENSEAL® RF60 Generator supplies and monitors the flow of RF energy to the patient’s tissue through the ENSEAL® Tissue Sealing Device. Indications The ENSEAL® RF60 Generator is intended to provide the required RF energy to the ENSEAL® Tissue Sealing Device for surgery and hemostasis in the operating room or in the emergency room. Contraindications The use of the ENSEAL® RF60 Generator and the attached ENSEAL® device are contraindicated, when in the judgment of the physician, radiofrequency surgery would be contrary to the best interest of the patient. The efficacy of the Ethicon Endo-Surgery ENSEAL® Vessel Sealing system for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the ENSEAL® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable. Warnings •

Verify that the unit is fully operational prior to administering tissue sealing on the patient.

•

Hazardous electrical output. This equipment is for use only by qualified medical personnel trained in the use of electrosurgery.

•

Do not operate the unit in close proximity to volatile solvents such as methanol or alcohol, or in the presence of flammable anesthetics, as explosion may occur.

•

Do not operate unit in moist environment, as a shock hazard may exist. If liquids have entered the unit, the RF60 Generator must be returned to the manufacturer for testing prior to use.

•

Interference produced by the operation of high-frequency surgical equipment may adversely affect the operation of other electronic medical equipment such as monitors and imaging systems.

•

Check if patient has a pacemaker or implanted cardioverter/defibrillator. Consult manufacturer for information about the effects of RF energy on these devices.

•

The ENSEAL® Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

•

Failure of the RF surgical equipment could result in an unintended increase of output power.

•

Use of accessories and cables, other than those specified may result in increased emissions or decreased immunity of the system.

•

No user serviceable parts. Return to factory.

•

Use only hospital grade power cord.

•

Risk of Fire - Replace fuses as marked. Refer to Chapter 6 - Repair and Replacement Procedures for fuse specifications and location.

•

Electric Shock Hazard --

Always disconnect the device from the electrical power source before cleaning or servicing.

--

High voltages may be present on surfaces inside the generator. Never touch an exposed conductive surface while the cover is removed and the unit is energized.

•

ESD Sensitive Components - The ENSEAL® RF60 Generator contains components that are sensitive to electrostatic discharge (ESD). Proper ESD precautions must be taken while servicing the ENSEAL® RF60 Generator. Repair work must be done at a static controlled workstation. Use an antistatic container for the transport of ESD sensitive circuit boards and components.

•

Servicing by qualified personnel only - To reduce the risk of electric shock, do not remove protective housing. Servicing should be performed by qualified personnel only.

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RF60 Service Manual Precautions •

Removing bottom screws and opening of this device may invalidate the warranty.

•

Read instructions prior to use, and follow the hospital’s clinical practice guidelines for electrosurgery, gynecology and laparoscopic procedures.

•

Replace fuses only with the same type and rating: 5mm x 20 mm 3.15 A/250 V AC slow-blow Type “T” (2 each).

•

Do not sterilize the ENSEAL® RF60 Generator. Sterilization may damage the unit.

•

Do not restrict the openings on the bottom of the RF60 Generator, as they provide the required airflow for cooling.

•

If electromagnetic interference with other equipment is suspected, reorient the device or remove possible sources of interference (e.g., cellular phones, radios and so on) from the room.

•

Any monitoring electrodes should be placed as far as possible from the disposable device tips when high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient. Monitoring systems incorporating high frequency current-limiting devices are recommended for use.

•

Needle monitoring electrodes are not recommended.

•

Activation of a radiofrequency device when not in contact with target tissue or in position to deliver energy to target may cause capacitive coupling.

•

Patient should not come into contact with earthed metal parts. The use of antistatic sheeting is recommended.

•

Cables to the surgical electrodes should be positioned such that contact with patient or other leads is avoided. Note: Bipolar techniques may be desirable in order to avoid unwanted coagulation for procedures where HF current could flow through relatively small cross section areas of the body.

Abbreviations RF60 EEF RF RFG

ENSEAL® RF60 Generator ENSEAL® Electronic Footswitch Radiofrequency RF Generator

How Supplied The shipping box contains a detached Ethicon Endo-Surgery footswitch and power cord. The disposable Ethicon Endo-Surgery ENSEAL® devices are not part of this packaging and must be purchased separately. Accessories The following accessories must be available for each patient use: •

ENSEAL® Electronic Footswitch (EEF) - Footswitch with 12 foot attached cable, and connector to RF60 Generator

•

Power cord - Hospital Grade, 18 AWG, 3 SJT, 10A / 125V

One of the following disposable devices are required: •

ENSEAL® Device with Round Tip - Product Code NSEAL 5xx RH where “xx” refers to shaft lengths of 14, 25, 35 or 45 cm

•

ENSEAL® Device with Standard Tip - Product Code NSEAL 5xx H where “xx” refers to shaft lengths of 14, 25, 35 or 45 cm

•

ENSEAL® Device with Standard Tip - Product Code ETRIO 3xx H where “xx” refers to shaft lengths of 14, 25, 35 or 45 cm

Setup •

Examine the RF60 Generator for damage. Do not use a damaged device. Plug in the ENSEAL® Electronic Footswitch (See Section - How Supplied) to the EEF Footswitch Connector.

•

Connect the power cord to the Power Connector on the back of the generator and to a power outlet. The power requirements for the RF60 Generator are located on the label on the back of the unit.

•

Make sure that there is at least one backup ENSEAL® Tissue Sealing Device available prior to use.

•

Connect the ENSEAL® Tissue Sealing Device to the RF60 Generator. Refer to setup instructions in the ENSEAL® Tissue Sealing Device Instructions for Use.

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RF60 Service Manual RF Indicators and Connectors 1

8

7

1 2 3 4 5

Standby Indicator RF On Indicator Complete Indicator Fault Indicator Replace Indicator

6 7 8 9

2

3

4

5

6

9

Control Indicator EEF Footswitch Connector Device Connector (RF AC Output) RF Enable Button

RXXXXX

10

10 11

11

On / Off Switch Fuse Drawer

12

13

12 13

Power Connector Equipotential Ground Lug

Initiation Once the setup is complete and power is turned on using the On / Off Switch at the back of the RF60 Generator, the generator enters the Standby state. Standby In Standby the generator cannot deliver RF power to the ENSEAL® Tissue Sealing Device and the green Standby indicator light is on. The RF60 Generator will enter the Standby state if idle for one hour (pressing the Electronic Footswitch or Handswitch resets the idle timer). Operation RF Enabled The RF60 Generator starts up in Standby state. Press the RF Enable button to put the generator in the RF Enable state. Press the RF Enable button again to return the generator to Standby. RF Enabled state is indicated by the flashing blue RF On indicator light. Self Test at RF On and Fault State The RF60 Generator performs a suite of self tests to ensure that it is functioning properly prior to entering the RF Enabled state. All indicator lights will come on and a beep will be heard for approximately one second. If any of these tests fail, the generator enters a Fault state indicated by the Fault indicator light and a Fault beep (three short beeps). Once it fails, the generator remains in the Fault state until powered down. If a fault condition exists, the indicator / error codes are displayed for a very brief period during the self-test, followed by the fault LED turning On. Note: Please verify that all the LEDs glow during the self-test. If any of the LEDs do not glow, DO NOT USE THE DEVICE. Contact the Ethicon Endo-Surgery Customer Service Department.

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RF60 Service Manual Replace Indicator The Replace indicator light indicates a resistance that is too low (short circuit) in the ENSEAL® device. The RF60 Generator will not deliver power while the Replace indicator light is on. RF Power Delivery When the generator is in the RF Enabled state and the ENSEAL® Tissue Sealing Device is detected, the operator can deliver power by pressing the footswitch or handswitch. RF Power is delivered only as long as either footswitch or handswitch is pressed. The blue RF On indicator light is steady and the RF beep is heard (one beep per second). During power delivery, a series of internal tests are performed by the generator to ensure efficacy and safety. The RF power delivery sequence is as follows: •

Power is delivered for a minimum of two seconds during which time the generator checks for a short circuit.

•

Repeating power delivery cycle; maximum power output 45 watts.

•

During power delivery, the generator checks for a short in the device (low resistance). If a short is detected the Replace indicator light is illuminated, and the generator returns to the RF Enabled state.

•

For Non-Handswitch devices: After the first 2 seconds of initiating RF power (and prior to 15 seconds), resistance is monitored until a resistance limit is met. When this limit is met, the Complete indicator light is illuminated briefly, a Cycle Complete beep is generated (long beep), and the generator returns to the RF Enabled state.

•

For Handswitch devices: RF power delivery will not be terminated until (1) a resistance limit is met (as above) and (2) the I-BLADE® is fully advanced to the end of the jaws, or (3) 15 seconds of power delivery has passed.

•

If the seal remains incomplete after 15 seconds, RF delivery terminates. In this case, the Control indicator light is illuminated, a Cycle Incomplete beep is generated (two short beeps), and the generator returns to the RF Enabled state. Note: Power needs to be reapplied if the tissue seal is NOT complete.

During RF delivery the RF ON indicator light is turned on, and the generator issues an RF beep (one beep per second). When RF power delivery is terminated prematurely by release of the footswitch or handswitch, the generator issues a Cycle Terminated beep (one second beep), and the generator returns to the RF Enabled state. Any time the RF power delivery is interrupted, the operator must release the footswitch or handswitch before starting a new tissue seal. Whenever RF power delivery is terminated and either the Complete indicator light or the Control indicator light is illuminated, they remain on for a period of one second. During this time, the generator remains in the RF Enabled state, and the footswitch or handswitch activity is ignored. Caution: User should apply power to tissue before advancing the I-BLADE®. Improperly sealed tissue may bleed when cut. Complete Indicator After engaging the footswitch or handswitch, RF power is delivered until the high resistance associated with a completed cycle is detected (Non-Handswitch units) and full I-BLADE® travel is recorded (Handswitch units). The Complete indicator light will illuminate, and a long beep will sound for one second, during which time the footswitch or handswitch is inactivated. The RF60 Generator does not monitor for high resistance during the first two seconds of power delivery. Always cut under power. Control Indicator If high resistance (Cycle Complete) and or full I-BLADE® travel is not detected, RF power delivery is terminated after 15 seconds, at which time the Control indicator light illuminates. The Control indicator light will illuminate for one second and two short beeps are heard, during which time the footswitch or handswitch is inactivated. Always cut under power. Footswitch or Handswitch Double-Tap Mode If the footswitch or handswitch is pressed twice within the first second of RF power delivery, the generator will deliver RF Power continually for as long as 2 minutes. RF power delivery can be terminated at any moment by releasing the footswitch or handswitch. During the Footswitch or Handswitch Double-Tap Mode, the RF Generator issues an RF “Double Beep” (two beeps per second).

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RF60 Service Manual Chapter 2 - RF60 Theory of Operation Detailed Hardware Description This section starts with the description of the overall functionality of the RF60 Generator to provide a proper perspective to the user. This is followed by the RF60 Main PCB I/O diagram and brief explanation of the same. Subsequently, block diagram of RF60 Main PCB is described with brief functional description of individual blocks at a functional level without going deep into the implementation details of the block. The overall functionality of the RF60 Generator is implemented in hardware and firmware. This description focuses on the functionality implemented in hardware. RF60 Generator Functionality Overview The ENSEAL® instruments that connect to the generator are surgical devices that combine high compression and low heat to quickly create strong vessel seals while generating minimal smoke, tissue char, or thermal injury. ENSEAL® instruments are designed with a unique polymer that responds like individual temperature controlled “switches”, which regulate the tissue sealing temperature by opening the circuit path when the tissue temperature reaches approximately 100°C. There are thousands of these “individual switches” in the polymer material at the jaws of each instrument. The smart electrode technology located in the jaws of the device provides feedback control for the delivery of energy. Therefore adjustments for differences in tissue density and impedance are possible. The ENSEAL® instruments are capable of sealing vessels up to 7mm in diameter. For cutting the tissue, the instruments use an I-BLADE® design, which is a mechanical motion that is a separate operation on the instrument. When the I-BLADE® is fully engaged, a micro-switch closes, and this signal is picked up by the generator to indicate “cut complete”. The RF60 is a 45W electrosurgical generator used to power ENSEAL® devices. The generator generates 480 kHz AC voltage at its RF output port. The RF power at the output port is precisely controlled by measuring the load voltage and load current by using a close loop PID control. The RF60 Generator performs various self tests before activation of the RF output and also when the power is supplied to the ENSEAL® device attached at the output port to ensure that the RF60 Generator is functioning properly. The RF60 Generator has one buzzer and six LEDs to indicate various states of operation and Fault condition. The RF at the output port can be activated by pressing footswitch attached to the Generator or by pressing on the ENSEAL® device handswitch. During the power delivery, the load impedance is continuously monitored to decide how long the power should be delivered. The power delivery to the load will be terminated in the following conditions: •

The user releases footswitch or ENSEAL® handswitch.

•

When Limit switch on the ENSEAL® device makes contact, and maximum impedance limit is reached.

•

RF is on for 15 seconds and still the maximum impedance limit is not reached.

•

Impedance falls below 5 Ω limit.

•

Any fault occurring during power delivery.

Detailed functionalities of the ENSEAL® device (Instrument) are discussed in the following sections.

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RF60 Service Manual RF60 Main PCB I/O Diagram Main PCB I/O Diagram

RF AC Output 24V Regulated DC Supply

Fan Buzzer

Ready Switch

STANDBY LED (GREEN) RF60 Main PCB

Handswitch

RF ON LED (BLUE) CONTROL LED (YELLOW) COMPLETE LED (GREEN) REPLACE LED (YELLOW)

Footswitch

FAULT LED (RED)

Figure 2.1 - RF60 Main PCB I/O Diagram Main PCB I/O Diagram Description Inputs to the RF60 Main PCB and outputs from RF60 Main PCB are shown in Figure 2.1 - RF60 Main PCB I/O Diagram. I/Os are primarily of two types: 1.

Power I/Os Power I/Os consist of the following: a. 24V Regulated DC Supply Input - This input comes from a medical AC/DC converter and is used to generate RF AC Output and to power the control circuit of RF60 Main PCB. b. RF AC Output - This output on the RF60 Generator front panel connects to a handpiece, and the 480 kHz sinusoidal waveform with variable output voltage is used to deliver power to the surgical site through the handpiece.

2.

User Interface I/Os User Interface I/Os consist of the following: a. RF Enable Button - This switch is located on the front panel of the RF60 Generator and is pressed by the user after power up to bring the RF60 Generator from standby to ready mode after doing the self test. b. Instrument Input - Switches located on the handpiece and connection are routed to the RF60 Main PCB through a handpiece connector (same connector through which RF AC output is connected to the handpiece) located on the front panel of the RF60 Generator. The user can press the RF activation switch to make the RF60 Generator operate in one of the two modes. •

Regular Mode - RF energy can be delivered up to 15 seconds.

•

Double-Tap Mode - Entered by double-tapping the activation switch. RF energy can be delivered up to 2 minutes.

The limit switch, which is activated on the handpiece once the I-BLADE® has been fully engaged, is used to serve as a limit switch to indicate the end of cut. c. Footswitch Input - This switch is connected to the RF60 Generator on the front panel of the generator. User needs to press the footswitch in order to activate the delivery of RF energy from the RF60 Generator. By double-tapping the footswitch, the user can make the RF60 Generator operate in the Double-Tap Mode as an alternative to using the instrument switches.

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RF60 Service Manual d. Buzzer Output - Buzzer is used for audio annunciation to indicate various states of the instrument to the user. The beeper generates tones at 2.4 kHz, and various tones are generated as follows: •

System Beep - Immediately following power up and during self test, the generator issues a one second beep.

•

End Display Beep - When the COMPLETE or CONTROL LED is turned off, a 100 milliseconds beep is issued.

•

Fault Beep - When a fault condition causing shutdown of the generator is detected or when the device resistance is out of range, the generator issues a continuous beep.

•

RF Beep - While delivering power to the device, the generator issues a 200 milliseconds long beep once per second.

•

Seal Complete Beep - When the impedance limit has been reached indicating a complete seal, the generator issues a one second beep.

•

Incomplete Seal Beep - When the maximum seal time has been reached, but the impedance limit has not (CONTROL), the generator issues 2 beeps of 50 milliseconds once every half second.

•

Short/Open Detected Beep - When the device impedance is out of range (device), the impedance is less than 3 Ω, or more than 2000 Ω and the generator issues 3 beeps of 50 milliseconds once every half second.

•

Cycle Terminated Beep - RF delivery determined by user, generator issues a single 1.0 second long beep.

•

No Impedance Limit RF Cycle Mode - When the device is in this mode, it will issue a 200 milliseconds long beep twice per second.

Note: All of the following LED outputs are located on the front panel of the RF60 Generator and indicate various states/faults during the operation of the instrument. e. STANDBY LED Output - This is a green LED indicating the generator is in Standby mode and unable to deliver. f. RF ON LED Output - This is a solid blue LED indicating the generator is delivering power to the patient. A flashing blue LED indicates the unit is pulsing RF power for device test. g. CONTROL LED Output - This is an yellow LED indicating an incomplete seal has occurred. h. COMPLETE LED Output - This is a green LED indicating the seal is complete. i. REPLACE LED Output - This is an yellow LED indicating the device needs to be replaced. j. FAULT LED Output - This is a red LED indicating a serious hardware or software failure has been detected. The generator is no longer functional.

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AC Line 1

Voltage Monitoring 28

Housekeeping DC-DC Converters 3

24V Regulated DC Power Supply 2

Power ON/OFF Control 27

Fixed Reference 5

RF Power Control 26

Power Modulation 6

7

Adjustable Buck Regulator 4

Voltage Sense 10

Dead Time Generation 16

24MHz Clock Reference 15

Current Sense 11

Primary Power Measurement 25

Over Current Set point 12

9

8

100nS Dead Time Pulse

480 KHz trig

RF Frequency ON/OFF Control 24

Gate Drive Generation 14

Push Pull Amplifier 13

20

Average Voltage Sense 21

Output Power and Impedance Measurement 23

Power Output

Average Current Sense 22

Current Sense 19

Voltage Sense 18

Temperature Sensing 29

Band Pass Filter 17

RF AC Output

RF60 Service Manual

RF60 Main PCB Functional Block Diagram Block Diagram

Figure 2.2 - Block Diagram of RF60 Main Board

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RF60 Service Manual Block Diagram Description The RF60 Main PCB is divided into the following major functional blocks, which in turn may contain additional sub-blocks. •

Adjustable buck regulator

•

Primary side current, voltage measurement, regulation, and RF output power control

•

Push pull amplifier

•

RF output filter

•

RF output voltage, current, and power measurement

•

User interface and communication

•

Health monitoring and diagnostics

• Housekeeping DC-DC converters The following numbers correspond to the numbers on Figure 2.2 - Block Diagram of RF60 Main Board. 1

AC Line Input - This block consists of a fuse protected inlet, which feeds AC main to the input of the 24V DC output medical grade AC-DC converter. This block is not part of the RF60 Main PCB but is shown here for sake of completeness.

2

24V Regulated AC-DC Converter - This block consists of a switch mode medical grade AC-DC converter and provides a galvanic isolation between the incoming AC main and rest of the RF60 circuits including the RF60 RF inverter. Output of the AC-DC converter is regulated 24V DC and feeds all the RF60 Generator circuit. AC-DC converter is off the shelf rated at 24V @ 130W. This block is not part of the RF60 Main PCB but is shown here for sake of completeness.

3

Housekeeping DC-DC Converters - This block generates +5V, +12V and -12V housekeeping power supplies for all of the RF60 Main PCB circuit. All the three voltages are generated using a buck switching regulator rated at 1A load current and capable of handling 8 to 40V DC input voltage range. Buck converter has over current and over temperature protection mechanisms. Housekeeping DC-DC converters feed the control circuitry of the RF60 Main PCB. Outputs of the housekeeping power supplies are fed to Primary Power Measurement Block 25, which checks whether all the three voltages are in a healthy state, at the time of power on self test. There is no specific power sequencing for the three outputs.

4

Adjustable Buck Regulator - This block consists of a buck regulator which takes in 24V DC regulated input voltage from AC-DC Converter Block 2 and provides variable DC output voltage, under the control of Power Modulation Block 6. Output of Adjustable Buck Regulator feeds the Push Pull Amplifier Block 13 which generates RF power signal in the form of quasi-square wave. Adjustable Buck Regulator provides an output voltage, which is in proportion to the output of the Error Amplifier Block 7. This allows adjusting the output voltage of the Adjustable Buck Regulator in order to control the power delivered from the RF AC output port by controlling the RF AC output voltage for the given tissue impedance. Adjustable Buck Regulator can be turned ON/OFF from the output of RF Power Control Block 26 in order to turn ON/OFF the input to Push Pull Amplifier Block 13 and hence turn ON/OFF power from the RF AC output port.

5

Fixed Reference - This block provides a fixed reference current of 122μA at the inverting terminal of the Error Amplifier Block 7.

6

Power Modulation - This block provides a variable reference current of 0 to 498μA at the non inverting terminal of the Error Amplifier Block 7. This programmable reference current, under the command from RF Frequency ON/OFF Control Block 24, allows the output voltage of the Adjustable Buck Converter Block 4 to be programmed from 0 to 24V DC.

7

Error Amplifier - This block compares the resultant reference current from Fixed Reference Block 5 and Power Modulation Block 6 and compares with Output Voltage Error Amplifier Block 8 to generate an error which in turn controls the Adjustable Buck Regulator Block 4.

8

Output Voltage/Current Control Error Amplifier - This block under normal operation of the Adjustable Buck Converter provides an output voltage scaling, of the Adjustable Buck Converter by a feedback fraction, for the Error Amplifier Block 7. In case of an overload condition on the output of the Adjustable Buck Regulator, over current error amplifier output from Over Current Error Amplifier Block 9, overrides the voltage feedback signal so as to adjust the Error Amplifier Block 7 output, which in turn reduces the Adjustable Buck Converter Block 4 output. This keeps the load current from Adjustable Buck Converter at a level defined by Over Current Set Point Block 12.

9

Over Current Error Amplifier - This block compares load current from the adjustable output buck regulator Block 4, with the output from Over Current Set Point Block 12 and generates an error, which in turn controls Blocks 8, 7 and 4. This keeps the load current from the Adjustable Buck Regulator Block 4 at a limit defined by Over Current Set Point Block 12.

10

Voltage Sense - This block converts an output voltage of the Adjustable Buck Regulator into a proportional current signal, which in turn is fed to the Output Voltage/Current Control Error Amplifier Block 8.

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RF60 Service Manual 11

Current Sense - This block senses the load current from the adjustable output buck regulator and level shifts, scales it appropriately, and feeds inverting input to Over Current Error Amplifier Block 9.

12

Over Current Set Point - This block provides a set point for adjustable output buck regulator Block 4, load current limit. If the load current exceeds this limit, the output voltage of the Adjustable Buck Regulator is reduced to keep the load current at over current limit point.

13

Push Pull Amplifier - This block generates a quasi square wave at a fixed frequency of 480 kHz and can provide a maximum peak voltage of 95V when output of the Adjustable Buck Regulator Block 4 is 24V DC. This block consists of two MOSFETs and a center tapped transformer along with the polarised RCD snubber circuit for each MOSFET. MOSFETs are operated at near 50% duty cycle with a small dead-time to prevent simultaneous conduction and current shoot through. Gate drive waveforms are generated by Gate Drive Generation Block 14. This block provides galvanic isolation between the RF AC Output port and the primary side power and control circuit because of the center tapped transformer.

14

Gate Drive Generation - This block generates 480 kHz gate drive waveform for Push Pull Amplifier Block 13. It takes in 24 MHz reference clock from 24 MHz Clock Reference Block 15, divides reference clock by 25 to generate 480 kHz 50% duty cycle square waveform. 480 kHz 50% duty square waveform is gated by Dead Time Generation Block 16 to reduce the 480 kHz duty cycle from 50% to somewhat less than 50%, which is finally provided as output of this block. 480 kHz output waveform of this block can be disabled from RF Frequency ON/OFF Control Block 24, if RF AC output from RF AC output port is to be disabled.

15

24 MHz Clock Reference - This block provides 24 MHz clock signal as base timing for all functional blocks which require time base.

16

Dead Time Generation - This block provides 100 nanoseconds dead time pulse to the Gate Drive Generation Block 14 in synchronisation with the 480 kHz 50% square waveform generated by Gate Drive Generation Block 14.

17

Band Pass Filter - This block contains a band pass filter tuned at a frequency of 480 kHz. It filters out harmonic contents in quasi square wave from the output of Push Pull Amplifier Block 13 and provides a sinusoidal waveform at the RF AC output port. The filter consists of series parallel LC circuit.

18

Voltage Sense - This block senses the RF AC output port voltage by means of a step down potential transformer, which provides two functions: • Scaling of the output voltage • Galvanic isolation between the RF AC output port and control circuit This block also provides noise filtering.

19

Current Sense - This block senses the RF AC output port current by means of a step down current transformer, which provides the following functions: • Scaling of the RF AC port current • Conversion of current signal to proportional voltage signal • Galvanic isolation between RF AC output port and control circuit

20

Multiplier - This block takes in the voltage and current feedback from Voltage Sense Block 18 and Current Sense Block 19 and multiplies to signals to generate power signal.

21

Average Voltage Sense - This block precision full wave rectifies and averages the input from Voltage Sense Block 18 to generate an average RF AC output port voltage.

22

Average Current Sense - This block precision full wave rectifies and averages the input from Current Sense Block 19 to generate an average RF AC output port current.

23

Output Power and Impedance Measurement - This block takes in outputs from Multiplier Block 20, Average Voltage Sense Block 21, and Average Current Sense Block 22 to calculate the tissue impedance and the power delivered by the RF AC Output Port.

24

RF Output On/Off Control - This block enables or disables the Push Pull Amplifier Block 13 to enable or disable RF power from the RF AC Output port.

25

Primary Power Measurement - This block takes in outputs from Voltage Sense Block 10 and Current Sense Block 11 to compute the primary power delivered to the input of the Push Pull Amplifier Block 13.

26

RF Power Control - This block provides an input to Power Modulation Block 6 in order to control the output voltage of the Adjustable Buck Regulator Block 4 to control power delivered out of the RF AC Output Port to the tissue load.

27

Power On/Off Control - This block enables or disables the Adjustable Buck Regulator output.

28

Voltage Monitoring - This block monitors the voltages of the housekeeping DC-DC converters at the time of self test.

29

Temperature Sensing - This block monitors the temperature inside the RF60 Generator.

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RF60 Service Manual Chapter 3 - Product Specifications Mode of Operation

Intermittent; 10 seconds on, 1 second off for 2 hours maximum

Main Fuses

5 mm x 20 mm Type “T” 3.15 A/250 V AC, (Quantity: 2; Schurter or equivalent)

Degree of Protection Against Electric Shock Defibrillator Proof - Type CF Class of Protection Against Electric Shock

Class 1

Ingress Protection RF60 Enclosure Ingress Protection RF60 Footswitch (EEF)

IP21 IP68

Main Input

Voltage: 100 - 240 V AC, Frequency: 50/60 Hz, Power: 180 VA

Output

Pure Cut Quasi-Sinusoid 45 Wmax, 150 Vmax Tissue Seal Mode, 480 kHz, 75 Ω load

Ambient Operating Conditions

Temperature: 50 °F to 105 °F (10 °C to 40 °C), Humidity: 30-75% non-condensing Atmospheric Pressure Range: 86 kPa - 106 kPa Note: Whenever the temperature goes above 50 °C or below 10 °C and the generator is in Standby or RF Enabled mode, it goes into a thermal shutdown.

Transport and Storage Conditions

Temperature: -4 °F to +140 °F (-20 °C to +60 °C), Humidity: 10-90% non-condensing Atmospheric Pressure Range: 50 kPa - 106 kPa

Weight

4.5 lbs (2 kg)

Overall Dimensions

RF60 Generator (HxWxD): 2¾ inch x 12 inch x 10½ inch (7 cm x 30.5 cm x 26.7 cm) Note: Weight and dimensions indicated are approximate. Specifications are subject to change without notice.

Conformance to Standards The ENSEAL® RF60 Generator conforms to the following electrical safety standards: IEC (EN) 60601-1:1990 + A1:1993 + A2:1995

Medical Electrical Equipment. Part 1: General Requirements for Safety

UL 60601-1:2006-04-26

Medical Electrical Equipment. Part 1: General Requirements for Safety

CSA/CAN C22.2 No.601.1-M90 (R2005)

Medical Electrical Equipment. Part 1: General Requirements for Safety

IEC (EN) 60601-1-2:2001

Medical Electrical Equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC (EN) 60601-2-2:2006

Medical Electrical Equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.

Electromagnetic Compatibility (EMC), Guidance, and Manufacturer Declarations Caution: RF60 needs special precautions regarding electromagnetic compatibility and needs to be installed and put into service according to the EMC information in this manual. Caution: Portable and mobile RF communications equipment can affect the RF60 system. Caution: Compliance with electromagnetic emissions and immunity require the use of hand pieces and instruments marketed by Ethicon Endo-Surgery for use on the RF60. Warning: The use of hand pieces, instruments, or spare parts other than those marketed by Ethicon Endo-Surgery may result in increased emissions or decreased immunity of the RF60 system. Warning: RF60 should not be used adjacent to or stacked with other equipment. If adjacent or stacked operation is necessary, RF60 should be observed to verify normal operation in the configuration in which it will be used.

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RF60 Service Manual

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The RF60 is intended for use in the electromagnetic environment specified below. The customer or the user of the RF60 should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment - Guidance

RF emissions CISPR 11

Group 2

The RF60 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

RF emissions CISPR 11

Class A

The RF60 is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 610003-3-3

Complies

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The RF60 is intended for use in the electromagnetic environment specified below. The customer or the user of the RF60 should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 6 kV Contact ± 8 kV Air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast Transient/Burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

± 1 kV line (s) to line (s) ± 2 kV line (s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips, Short Interrupts, and Voltage variations on Power Supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0,5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 s

Mains power quality should be that of a typical commercial or hospital environment. If the user of the RF60 requires continued operation during power mains interruptions, it is recommended that the RF60 be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

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RF60 Service Manual Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The RF60 is intended for use in the electromagnetic environment specified below. The customer or the user of the RF60 should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the RF60, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3 Vrms

d = 1.2 P

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m

d = 1.2 P

80 MHz to 800 MHz

d = 2.3 P

800 MHz to 2.5 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitter, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RF60 is used exceeds the applicable RF compliance level above, the RF60 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RF60.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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RF60 Service Manual Recommended separation distances between portable and mobile RF communications equipment and the RF60 The RF60 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the RF60 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RF60 as recommended below, according to the maximum output power of the communications equipment. Rated maximum ouput power of transmitter W

Separation distance according to frequency of transmitter M 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 1.2 P

d = 2.3 P

0.01

0.12

0.23

0.1

0.38

0.73

1.0

1.20

2.30

10

3.79

7.27

100

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Chapter 4 - Warranty and Technical Support 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 normal use and preventive maintenance for the respective warranty period shown below. 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 or its Distributor within the applicable time period shown below and which examination disclosed, to Ethicon Endo-Surgery’s satisfaction, to be defective. This warranty does not apply to any product, or part thereof, that has been: (1) adversely affected due to use with devices manufactured or distributed by parties not authorized by Ethicon Endo-Surgery (2) repaired or altered outside Ethicon Endo-Surgery’s factory in a way so as to, in Ethicon Endo-Surgery’s judgement, affect its stability or reliability, (3) subjected to improper use, negligence or accident, or (4) used other than in accordance with the design and use parameters, instructions and guidelines for the product or with functional, operational 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: Generators Footswitches and Cable

One (1) Year, Parts and Labor One (1) Year, Parts and Labor

UNLESS SUPERCEDED BY APPLICABLE LOCAL LAW, THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF ETHICON ENDO-SURGERY AND IS A PURCHASER’S EXCLUSIVE REMEDY. IN NO EVENT SHALL ETHICON ENDO-SURGERY BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING, WITHOUT LIMITATION, DAMAGES RESULTING FROM LOSS OF USE, PROFITS, BUSINESS OR GOODWILL, OTHER THAN AS EXPRESSLY PROVIDED BY A SPECIFIC LAW. Ethicon Endo-Surgery neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Ethicon Endo-Surgery products. There are no warranties that extend beyond the terms hereof. Ethicon Endo-Surgery reserves the right to make changes to products built and/or sold by them at any time without incurring any obligation to make the same or similar changes on products previously built and/or sold by them.

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RF60 Service Manual Customer Service Contact the Ethicon Customer Service Department for any customer or technical support. Call 1-800-USE-ENDO.

Chapter 5 - Troubleshooting Indicators / Error Codes The RF60 Generator supports a series of alarms and error codes to help in the identification and troubleshooting of component problems. The following lists are meant as an adjunct to, but not a substitute for, clinical judgment and observation. Audible Indicator

Description

RF Beep

0.2 second long beep once per second while RF energy is being delivered.

RF Double Beep

0.2 second long beep twice per second while RF energy is being delivered in Footswitch or Handswitch Double-Tap Mode.

System Beep

Immediately following power up, all indicator lights come on for a second, and during the self test, the generator issues a single 1.0 second long beep.

Cycle Incomplete Beep

When the maximum tissue seal time has been reached but the resistance limit has not, the generator issues a 0.05 second long beep with a 0.5 second pause, 2 times.

Cycle Terminated Beep

RF Delivery is terminated by user, the generator issues a single 1.0 second long beep.

Visual Indicator / Error Code

Function

Troubleshooting Steps

Replace indicator or Fault indicator light stays on

ENSEAL® device Short

Replace or reattach instrument to generator.

All indicators illuminate for a second, System Beep

RF60 Generator Wake up

No action needed

All indicators flashing

Self Test Fails

Turn RF60 Generator Off / On (Cycle Power). If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

Complete indicator illuminates

Seal Cycle completed

No action needed

Visual and Audible Indicators

Description

Troubleshooting Steps

Fault Beep, Fault indicator illuminates

When the device resistance is out of range, the generator issues a 0.05 second long beep, 3 times.

Replace device

Continuous tone, Fault Indicator illuminates

When a fault condition causing shutdown of the generator is detected, the generator issues a continuous tone.

Cycle Power and replace device.

Cycle Complete indicator illuminates, Cycle Complete Beep

When the resistance limit has been reached, the generator issues a single 1.0 second long beep.

No action needed

Control indicator illuminates, Cycle Incomplete Beep

Cycle was not completed

Reapply RF Power by footswitch or handswitch activation

RF ON LED momentarily lit / FAULT LED continuously lit / Fault Beep

RF Power Self Test Fault

Cycle Power. If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

RF ON LED momentarily lit / COMPLETE LED momentarily lit / FAULT LED continuously lit / Fault Beep

Residual of excessive RF Power Self Test Fault

Cycle Power. If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

FAULT LED continuously lit / REPLACE LED momentarily lit / Fault Beep

RF Impedance Self Test Fault

Replace instrument

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RF60 Service Manual STANDBY LED momentarily lit / RF ON LED momentarily lit / FAULT LED continuously lit / Fault Beep

Ambient Temperature Fault

Check for air flow. Replace PCB.

STANDBY LED momentarily lit / FAULT LED continuously lit / Fault Beep

ROM Self Test Fault

Replace PCB

STANDBY LED momentarily lit / COMPLETE LED momentarily lit / FAULT LED continuously lit / Fault Beep

RAM Self Test Fault

Replace PCB

STANDBY LED momentarily lit / FAULT LED continuously lit / CONTROL LED momentarily lit / Fault Beep

Timer Self Test Fault

Replace PCB

STANDBY LED momentarily lit / FAULT LED continuously lit / REPLACE LED momentarily lit / Fault Beep

Power Supply Test Fault

Cycle Power. If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

COMPLETE LED momentarily lit / FAULT LED continuously lit / Fault Beep

RF Enable Button Test Fault

Cycle Power. If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

FAULT LED continuously lit / CONTROL LED momentarily lit / Fault Beep

Footswitch / Handswitch Self Test Fault

Cycle Power. If fault continues, diagnose using schematic, and replace faulty parts using the assembly diagram as a reference.

Note: For Fault conditions described above, the FAULT LED is continuously lit, and the other LEDs are momentarily lit and then go off.

Chapter 6 - Repair and Replacement Procedures Introduction This chapter describes how to repair and replace the following components of the RF60 Generator. 1.

Enclosure top

2.

Fuse assembly

3.

Fan assembly

4.

Power entry module

5.

Power supply

6.

Main PCB board

7.

Footswitch receptacle

8.

ENSEAL® connector

9.

RF60 overlay

10. Bottom enclosure

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Johnson & Johnson Medical

EnSeal Electrosurgical Generators

EnSeal RF60 Service Manual Rev A