EnSeal RF60 Generator Instructions for Use Rev B July 2009

RF60 Generator Instructions for Use Chapter 1 - General Information Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences. Important: This manual is designed to provide instructions for use of the EnSeal® RF60 Generator. It is not a reference to surgical techniques. EnSeal® is the trademark 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. Abbreviations RF60 EEF RF RFG

EnSeal® RF60 Generator EnSeal® Electronic Footswitch Radiofrequency RF Generator

Chapter 2 - Instructions for Use Setup •

Examine the RF60 Generator for damage. Do not use a damaged device. Plug in the EnSeal® Electronic Footswitch 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.

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

RF Indicators and Connectors 1

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Standby Indicator RF On Indicator Complete Indicator Fault Indicator Replace Indicator

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10 11

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12

6 7 8 9

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

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Power Connector Equipotential Ground Lug

13

On / Off Switch Fuse Drawer

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 more than one hour (pressing on 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. 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. Replace Indicator The Replace 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 the 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.

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RF60 Generator Instructions for Use •

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 tissue 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.

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 short beep), and the generator returns to the RF Enabled state. Whenever 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. 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. 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. 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).

Chapter 3 - 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. Other than fuses, there are no other operator-serviceable parts in the RF60 Generator. For replacement, contact the Ethicon Endo-Surgery Customer Service Department. 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.

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RF60 Generator Instructions for Use 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, contact Customer Service.

Cycle Complete indicator illuminates

Seal Cycle completed

No action needed

Visual and Audible Indicator

Description

Troubleshooting Steps

Fault beep, Fault indicator illuminates

When a fault condition causing shutdown of the generator is detected or when the device resistance is out of range, the generator issues a 0.05 second long beep, 3 times.

Replace device

Control indicator illuminates, Cycle Incomplete beep

Cycle was not completed

Reapply RF Power by footswitch or handswitch activation

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

RF ON / FAULT / Fault beep

RF Power Self Test Fault

Contact Customer Service.

RF ON / COMPLETE / FAULT / Fault beep

Residual of excessive RF Power Self Test Fault

Contact Customer Service.

FAULT / REPLACE / Fault beep

RF Impedance Self Test Fault

Replace instrument

STANDBY / RF ON / FAULT / Fault beep

Ambient Temperature Fault

Check for air flow. Contact Customer Service.

STANDBY / FAULT / Fault beep

ROM Self Test Fault

Contact Customer Service.

STANDBY / COMPLETE / FAULT / Fault beep

RAM Self Test Fault

Contact Customer Service.

STANDBY / FAULT / CONTROL / Fault beep

Timer Self Test Fault

Contact Customer Service.

STANDBY / FAULT / REPLACE / Fault beep

Power Supply Test Fault

Contact Customer Service.

COMPLETE / FAULT / Fault beep

RF Enable Button Test Fault

Contact Customer Service.

FAULT / CONTROL / Fault beep

Footswitch / Handswitch Self Test Fault

Contact Customer Service.

®

Additional Information •

If the Fault indicator light or Replace indicator is illuminated, the EnSeal® device is defective, or short, and the device or cable must be replaced. If this happens during a procedure, this could result in incomplete tissue seal. DO NOT CUT tissue! Replace device and repeat procedure.

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Lightly closed jaws or thick tissue may result in Cycle Complete indication before the tissue seal is complete. Always advance the blade with RF power being delivered.

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In the event that the jaws of the EnSeal® device fail to open, tie off tissue at each side of the jaw, then cut and remove the tissue segment trapped in the jaw. Dispose of device. Do not reuse!

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In the event of a thermal shut down (temperature is above 50° C or below 10° C), the generator stays in Fault mode until the temperature returns to normal operating conditions.

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RF60 Generator Instructions for Use •

This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and radiates radiofrequency (RF) energy, and, if not installed and used in accordance with the instructions, may cause a harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the operator is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving device. -- Increase the separation between the equipment. -- Connect the RF60 Generator to an outlet on a circuit different from the affected equipment.

Chapter 4 - Preventive Maintenance, Repair, Cleaning, and Disinfection Fuse Replacement In the event of a blown fuse, only 5 mm x 20 mm 3.15 A/250 V AC Type “T” (slow blow) fuses should be used as replacements. Turn power off, and disconnect the power cord from the wall outlet. Remove fuse holder by opening the Power Entry Module’s Fuse Drawer on the back of the generator. Replace both fuses. Other than these fuses, there are no other operator-serviceable parts. For replacement, contact the Ethicon Endo-Surgery Customer Service Department. Regularly inspect the footswitch and device cable for damage to insulation. Electrical Safety Checks •

The unit should have an electrical safety check at least once a year. This consists of a leakage current test and a dielectric withstand test.

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The customer is responsible for ensuring that only a qualified service provider performs the electrical safety checks.

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Do not remove the cover of the RF60 Generator. Removing the cover voids the RF60 Generator warranty.

Cleaning and Disinfection Instructions •

Operators in North America should refer to appropriate sections of AORN Standards & Recommended Practices for additional guidance on cleaning. All other localities should refer to appropriate guidelines.

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The operator must qualify cleaning effectiveness if the operator deviates from the instructions in this manual.

Cleaning the Generator Clean the generator 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 device and risk of shock or fire hazard. Proceed with cleaning as follows: 1.

Prepare a neutral pH detergent or a neutral pH enzymatic detergent according to the manufacturer’s directions.

2.

Use a soft, clean cloth lightly moistened with the cleaning solution to manually clean all surfaces (including the generator’s display).

3.

Rinse thoroughly using a soft, clean cloth lightly moistened with warm tap water.

4.

Dry with a clean, soft cloth.

Disinfecting the Generator If the generator becomes contaminated with blood or bodily fluid, a disinfection step must follow the cleaning of the device/equipment. The following chemical disinfectants are approved for use with the generator: Deconex 50 AF, Mikrobac, Bacillol Plus, Bacillol AF, Kohrsolin, Bacillocid rasant, Simple Green D Pro 3, Isopropyl Alcohol - 70%, and Sodium hypochlorite solutions (i.e., 10%). Disinfectants should be prepared and used according to the manufacturer’s recommendations for use, concentration, and contact time. Use of other disinfectants: The use of disinfectants, other than those specified in these instructions, should be assessed for material compatibility before using. At a minimum, intermediate level disinfectants should be used. Technical data sheets are typically available through the manufacturer’s web pages to assist in this assessment. Any disinfection process, including tools and solutions, may influence the wear and tear on a device or equipment. In some instances, changing to another disinfectant may be required.

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RF60 Generator Instructions for Use Within the applied decontamination process, ensure that detergent and disinfectant residuals are sufficiently removed. Use purified or deionized water during final rinsing processes, where applicable (multiple rinses may be required). Refer to the manufacturer’s recommendations for the removal of the disinfectant residuals. Cleaning the EnSeal® Electronic Footswitch (EEF) Note: Keep the footswitch cable connector that connects to the generator dry at all times. Proceed with cleaning as follows: 1.

Prepare a neutral pH detergent or a neutral pH enzymatic detergent according to the manufacturer’s directions.

2.

Use a soft, clean cloth lightly moistened with the cleaning solution to manually clean all surfaces.

3.

Rinse thoroughly using a soft, clean cloth lightly moistened with warm tap water.

4.

Dry with a clean, soft cloth.

Disinfecting the EnSeal® Electronic Footswitch If the footswitch becomes contaminated with blood or bodily fluid, a disinfection step must follow the cleaning of the device/equipment. Note: Keep the footswitch cable connector that connects to the generator dry at all times. The following chemical disinfectants are approved for use with the footswitch: Deconex 50 AF, Mikrobac, Bacillol Plus, Bacillol AF, Kohrsolin, Bacillocid rasant, Simple Green D Pro 3, Isopropyl Alcohol - 70%, and Sodium hypochlorite solutions (i.e., 10%). Disinfectants should be prepared and used according to the manufacturer’s recommendations for use, concentration, and contact time. Use of other disinfectants: The use of disinfectants, other than those specified in these instructions, should be assessed for material compatibility before using. At a minimum, intermediate level disinfectants should be used. Technical data sheets are typically available through the manufacturer’s web pages to assist in this assessment. Any disinfection process, including tools and solutions, may influence the wear and tear on a device or equipment. In some instances, changing to another disinfectant may be required. Within the applied decontamination process, ensure that detergent and disinfectant residuals are sufficiently removed. Use purified or deionized water during final rinsing processes, where applicable (multiple rinses may be required). Refer to the manufacturer’s recommendations for the removal of the disinfectant residuals. Disposing of EnSeal® RF60 Generator The device must not be disposed of at the end of life with other waste. To recycle waste equipment, obtain a Return Goods Authorization Number (“RGA Number”) and return instructions from the Ethicon Endo-Surgery Customer Service Department or sales representative. Environmental Protection Follow local governing ordinances and hospital practice regarding the disposal of the disposable tissue sealing devices.

Chapter 5 - Warnings and Precautions Warnings •

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

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

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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.

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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.

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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.

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

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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.

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

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

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RF60 Generator Instructions for Use •

No user serviceable parts. Return to factory.

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Use only hospital grade power cord.

Precautions •

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

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

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

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

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

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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.

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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.

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Needle monitoring electrodes are not recommended.

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

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

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Cables to the surgical electrodes should be positioned so that contact with patient or other leads is avoided.

Note: Bipolar techniques may be desirable to avoid unwanted coagulation for procedures where HF current could flow through relatively small cross-section areas of the body.

Chapter 6 - System 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

IP21 IP68

Main Input

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

Output

Pure Cut Quasi-Sinusoid 60 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 (7cm x 30.5cm x 26.7cm) Note: Weight and dimensions indicated are approximate. Specifications are subject to change without notice.

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RF60 Generator Instructions for Use Chapter 7 - Conformance to Standards The EnSeal® RF60 Generator conforms to the following international standards: EN 60601-1 (w/amendments)

Medical Electrical Equipment. Part 1: General Requirements for Safety

UL 2601-1

Medical Electrical Equipment. Part 1: General Requirements for Safety

CSA C22.2 No.601.1-M92

Medical Electrical Equipment. Part 1: General Requirements for Safety

EN 60601-1-2

Medical Electrical Equipment. Part 1:2. Collateral Standard: Electromagnetic Compatibility

IEC 60601-1-4

Medical Electrical Equipment General Requirements for Safety Part 1-4: Collateral standard: Programmable Electrical Medical Systems

EN 60601-2-2

Medical Electrical Equipment, Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment

ANSI/AAMI HF 18

American National Standard for Electrosurgical Devices

ANSI/AAMI/ISO 15223

Graphical Symbols for Use on Equipment

EN 60529

Degrees of Protection Provided by Enclosures (IP Code)

ANSI/AAMI ES-1

Safe Current Limits for Electromedical Apparatus

ISTA 2A

Pre-shipment Test Procedures, Export Shipment

EN 55011 (CISPR 11)

Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) RF equipment

MDD 93/42/EEC

Medical Device Directive (Council Directive Concerning Medical Devices)

IEC/CEI 62353

Medical Electrical Equipment - recurrent test and test after repair of medical electrical equipment

Chapter 8 - Customer Service 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 EndoSurgery 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 Generator Instructions for Use Customer Service Contact the Ethicon Customer Service Department or your local representative for any customer or technical support. Call 1-800-USE-ENDO.

Chapter 9 - How Supplied The EnSeal RF60 Generator is supplied in a semi-ready-to-use state. 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 - Footswitch with 12-foot attached cable, and connector to RF60 Generator

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Power cord - Any hospital grade cord approved for the region

The following disposable device is required: •

EnSeal® Tissue Sealing Device

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RF60 Generator Instructions for Use Chapter 10 - Graphs The curves in the following graphs represent typical curves. RF60 Power Curve 4/4:19 Xfrmr 70.00 - Power 60.00

50.00

Power - Watts

40.00

30.00

20.00

10.00

0.00

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Impedance - Ohms

Maximum Voltage RMS - software control 100.00 90.00 80.00 70.00 - Vpk-SW

Voltage - peak

60.00 50.00 40.00 30.00 20.00 10.00 0.00

1500

1000

500

0

2500

2000

Impedance - Ohms

RF60 Power Curve 4/4:19 Xfrmr 160.00 - Vpk 140.00

120.00

100.00

Voltage - Peak

80.00

60.00

40.00

20.00

0.00 0

200

400

600

800

1000

1200

1400

1600

1800

2000

Impedance - Ohms

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CAF NO.

CHNG

DATE

A

09 - 01890

KWU

6-23-09

B

09 - 02553

KWU

7-20-09

PRODUCT CODE

ARTWORK NUMBER

COMPONENT NUMBER

RF60

A87372P00

P43556P01

CONFIDENTIAL : NOT TO BE REPRODUCED OR USED IN ANY WAY WITHOUT WRITTEN ETHICON ENDO-SURGERY, INC. APPROVAL. CINCINNATI, OH

REVISIONS LTR