Force FX 8CAS Service Manual Dec 2014

Service Manual

Force FX

TM

Electrosurgical Generator 8CAS

PT00002139

Preface This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for servicing the Force FX Electrosurgical Generator 8CAS only. Additional information about the generator is available in the Force FX Electrosurgical Generator 8CAS User’s Guide. TM

Equipment covered in this manual: Covidien Force FX Electrosurgical Generator 8CAS -110 V ~ Nominal / 230 V ~ Nominal (auto selected) The Force FX Electrosurgical Generator 8CAS Service Manual consists of two parts-the text (part 1 of 2) and a Schematics Supplement (part 2 of 2).

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Precaution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. Notice Indicates a hazard which may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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Limited Warranty Covidien warrants the covered product listed below to be free from defects in material and workmanship for normal use and service for the period(s) set forth below. Covidien’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it (or its authorized distributor) within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Covidien’s satisfaction, that the product is defective. This limited warranty does not apply to any product, or part thereof, which has been repaired or altered in a way so as, in Covidien’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty period for this Covidien product is as follows: Electrosurgical Generators

One year from date of shipment

Mounting Fixtures (all models)

One year from date of shipment

Footswitches (all models)

One year from date of shipment

Sterile Single Use Items

Sterility only as stated on packaging

Patent Return Electrodes

Shelf life only as stated on packaging

Notwithstanding any other provision herein or in any other document or communication, Covidien’s liability with respect to this limited warranty and the products sold hereunder shall be limited to the aggregate purchase price for the products sold to the customer. This limited warranty is non-transferable and runs only to the original purchaser of the covered product(s). There are no warranties which extend beyond the terms hereof. Covidien disclaims any liability hereunder or elsewhere in connection with the sale of products and for any form of indirect, tort, or consequential damages. This limited warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this limited warranty is the District Court of the County of Boulder, State of Colorado, USA. Covidien reserves the right to make changes in covered products built or sold by it at any time without incurring any obligation to make the same or similar changes to equipment previously built or sold by it. THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS EXPRESSLY PROVIDED HEREIN, COVIDIEN DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

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Software License Covidien llc, (collectively called “COVIDIEN” herein) own the entire right, title, and interest in and to all of the computer programs and all portions thereof, and associated documentation (collectively, the “Software”) provided to Customer as may be installed in the Products and equipment addressed herein or provided separately, and it has the sole right to grant licenses hereunder. The evaluation allowance herein and any ultimate price paid by Customer for the products incorporating the Software include as a portion of that evaluation allowance, or price, a license fee granting Customer only the rights set forth in this Software License. Customer further acknowledges and agrees that the Software is owned exclusively by COVIDIEN. The Software is licensed to be used on only one computing device or Product, and a valid license must be purchased for each computing device on which the Software is installed. Single User License Grant: COVIDIEN grants to Customer a limited, nonexclusive, nonsublicensable, nontransferable and revocable license to use the Software, exclusively at Customer’s location as identified by Customer as the ship-to location of the Product, solely in machine-readable object code form only on a single central processing unit owned or leased by Customer or otherwise embedded in equipment provided by COVIDIEN, and for the sole purpose of Customer’s internal business purpose in the operation of the Product or equipment purchased from, other otherwise provided by, COVIDIEN or its affiliates. Except to the extent expressly authorized in this Software License or by law, Customer shall not and shall not cause any third party to: (i) decompile, disassemble, or reverse engineer the Software; (ii) modify or create any derivative works (including, without limitation, translations, transformations, adaptations or other recast or altered versions) based on the Software, or alter the Software in any way; (iii) merge the Software with any other software or product not supplied by Supplier; (iv) use, copy, sell, sublicense, lease, rent, loan, assign, convey or otherwise transfer the Software except as expressly authorized by the Agreement; (v) distribute, disclose or allow use of the Software, in any format, through any timesharing service, service bureau, network or by any other means, to or by any third parties; (vi) remove or modify any copyright, confidential and/or proprietary markings, legends or restriction which are in the Software originally supplied to Customer; or (vii) violate any obligations with regard to COVIDIEN’s Confidential Information. To the extent that Customer is expressly permitted by applicable mandatory law to undertake any of the activities listed in the preceding sentence, Customer will not exercise those rights until Customer has given COVIDIEN thirty (30) days written notice of Customer’s intent to exercise any such rights unless an order of a government agency of competent jurisdiction will not so allow. Except for the limited license rights expressly granted in this Software License, COVIDIEN reserves all rights in and to the Software and any modifications thereto and derivations thereof, including, but not limited to, all title, ownership, intellectual property rights and all other rights and interests. Customer will own only the hardware or physical media on which the Software is stored or processed, if any. Customer agrees that the Software, including the specific design and structure of individual programs, constitute confidential information and trade secrets of COVIDIEN, whether or not the programs may be copyrighted or copyrightable, and/or patented or

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patentable. Customer agrees not to disclose, provide, or otherwise make available such confidential information, trade secrets or copyrighted material in any form to any third party. Customer agrees that it will make the Software available only to employees, contractors, or consultants with a need to know, who are obligated to comply with all license restrictions contained in this Software License Agreement and to maintain the secrecy of the Software and all other Confidential Information. Customer is responsible for the compliance of all users with these obligations. Customer may, from time to time, request that COVIDIEN incorporate certain features, enhancements or modifications into the Software. COVIDIEN may, in its sole discretion, undertake to incorporate such changes and distribute the Software so modified to all or any of COVIDIEN's customers. All such error corrections, bug fixes, patches, updates or other modifications provided to COVIDIEN shall be the sole property of COVIDIEN. This Software License is effective until terminated. Customer may terminate this License at any time by destroying all copies of Software including any documentation. This License will terminate immediately upon notice from COVIDIEN if Customer fails to comply with any provision of this License or any supplier agreement. COVIDIEN may terminate the Software licenses granted herein and exercise all available rights by giving written notice, effective immediately, if within ten (10) business days of Customer’s receipt of a reasonably detailed written request to cure, Customer has not cured all breaches of this License’s limitations or restrictions. Upon such termination, Customer will immediately pay all undisputed fees outstanding, cease use of all Software, return or delete, at COVIDIEN’s request, all copies of the Software in Customer’s possession, and certify compliance with all of the obligations herein to COVIDIEN in writing. Limited Warranty: COVIDIEN represents and warrants to Customer that the Software will perform substantially as described in COVIDIEN's then current documentation for such Software for the longer of (a) the remaining warranty applicable to the product with which such Software was delivered (not to exceed one year) or (b) ninety (90) days from the date such Software was shipped or first made available to Customer for electronic download from COVIDIEN’s service site. If you notify COVIDIEN of defects during the warranty period, COVIDIEN will replace the Software or, at its option, refund the purchase price. Your remedy for breach of this limited warranty shall be limited to replacement or refund and shall not encompass any other damages. No dealer, distributor, agent or employee of COVIDIEN is authorized to make any modification or addition to the warranty and remedies stated above. Notwithstanding these warranty provisions, all of COVIDIEN's obligations with respect to such warranties shall be contingent on Customer’s use of the Software in accordance with this Agreement and in accordance with COVIDIEN's instructions as provided by COVIDIEN in the documentation, as such instructions may be amended, supplemented, or modified by COVIDIEN from time to time. COVIDIEN shall have no warranty obligations with respect to any failures of the Software which are the result of accident, abuse, misapplication, extreme power surge or extreme electromagnetic field. This warranty does not apply to any damages, malfunctions, or non-conformities caused to or by: (i) Customer’s use of Software in violation of the license granted under the Agreement or in a manner inconsistent with any provided documentation; (ii) use of nonCOVIDIEN furnished equipment, software, or facilities with its equipment or Products; (iii) Customer’s failure to follow COVIDIEN’s installation, operation, repair or maintenance instructions; (iv) Customer’s failure to permit COVIDIEN timely access, remote or

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otherwise, to Products; (v) failure to implement all new Updates to Software provided under the Agreement; (vi) Products or equipment with their original manufacturer’s serial numbers altered, defaced or deleted; (vii) Products or equipment that have been altered, serviced or modified by a party other than COVIDIEN; or (viii) Software that has been subjected to abnormal physical or electrical stress, misuse, negligence or accident by Customer or a third party. DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA, OR FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF THIS SOFTWARE LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE PRICE PAID OR TO HAVE BEEN PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE ABOVE-STATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES. U.S. Government Rights. The Software is a “commercial item” developed exclusively at private expense, consisting of “commercial computer software” and “commercial computer software documentation” as such terms are defined or used in the applicable U.S. acquisition regulations. The Software is licensed hereunder (i) only as a commercial item and (ii) with only those rights as are granted to all other customers pursuant to the terms and conditions of this License. Customer shall not use, duplicate, or disclose the Software in any way not specifically permitted by this License. Nothing in this License requires COVIDIEN to produce or furnish technical data for or to Customer. If any provision of this Agreement shall be held by a court of competent jurisdiction to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect. This License Agreement contains the entire understanding and agreement between the parties respecting the Software. This Agreement may not be supplemented, modified, amended, released or discharged except by an instrument in writing signed by each party's duly authorized representative. All captions and headings in this Agreement are for purposes of convenience only and shall not affect the construction or interpretation of any of its provisions. Any waiver by either party of any default or breach hereunder shall not constitute a waiver of any provision of this Agreement or of any subsequent default or breach of the same or a different kind. The construction and performance of this Agreement will be governed by the laws of the State of Colorado without reference to its choice of law principles. The parties hereby submit to the jurisdiction of the courts of the State of Colorado.

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Table of Contents Preface... ii Conventions Used in this Guide... ii Limited Warranty... iii Software License...iv Table of Contents... v

Chapter 1. Introduction General Description... 1-2 List of Components... 1-2 Service Personnel Safety... 1-3 General... 1-3 Active Accessories... 1-4 Patient Return Electrodes... 1-4 Fire/Explosion Hazards... 1-4 Electric Shock Hazards... 1-5 Servicing... 1-5 Calibration... 1-6 Cleaning... 1-6

Chapter 2. Controls, Indicators, and Receptacles Front Panel... 2-2 Bipolar Controls... 2-3 Bipolar Instrument Receptacle... 2-4 Monopolar Cut Controls... 2-5 Monopolar Coag Controls... 2-6 Monopolar Instrument Receptacles... 2-7 REM Alarm Indicator... 2-8 Rear Panel... 2-9 Footswitch Receptacles... 2-10 Monopolar Footswitch Receptacles... 2-10 Bipolar Footswitch Receptacle... 2-10 Power Entry Module... 2-11 Activation Tone Volume Control... 2-11 Option Panel... 2-12

Chapter 3. Technical Specifications Performance Characteristics... 3-2 General... 3-2 Dimensions and Weight... 3-2 Operating Parameters... 3-2

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Transport and Storage... 3-3 Duty Cycle... 3-3 Internal Memory... 3-4 Audio Volume... 3-5 REM Contact Quality Monitor... 3-5 Serial Port... 3-6 RF Activation Port... 3-7 Expansion Port... 3-7 Low Frequency (50–60 Hz) Leakage Current... 3-7 High Frequency (RF) Leakage Current... 3-8 Input Power... 3-8 Power Cord Specification... 3-9 Standards and IEC Classifications... 3-10 Class I Equipment (IEC 60601-1)... 3-17 Type CF Equipment (IEC 60601-1)/Defibrillator Proof . . . 3-17 Liquid Spillage... 3-17 Electromagnetic Interference... 3-17 Electromagnetic Compatibility... 3-18 Cables Used for the Force FX EMC Test... 3-19 Voltage Transients (Emergency Generator Mains Transfer)... 3-20 Output Characteristics... 3-25 Maximum Output for Bipolar and Monopolar Modes . . . 3-25 Maximum Output for Ultrasonic Electrosurgery... 3-26 Available Power Settings in Watts... 3-26 Output Waveforms... 3-29 Output Power vs. Resistance Graphs... 3-31 Bipolar Graphs... 3-31 Monopolar Cut Graphs... 3-37 Monopolar Coag Graphs... 3-43

Chapter 4. Principles of Operation Block Diagram... 4-2 Functional Overview... 4-3 Instant Response Technology... 4-3 Ultrasonic Electrosurgery... 4-3 Simultaneous Coag... 4-3 REM Contact Quality Monitoring System... 4-4 Control Board... 4-5 Microcontrollers... 4-5

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Main Microcontroller... 4-6 Shared RAM... 4-8 I/0 Expansion... 4-8 Keyboard Interface and Activation Inputs... 4-8 Power Supply Supervisor Circuit... 4-8 A/D and D/A Conversion... 4-9 Waveform Generation (T_ON ASIC)... 4-9 T_ON Average Check... 4-9 Audio Alarm... 4-10 Serial Interface... 4-10 Dosage Error Algorithm... 4-11 Instant Response Algorithm... 4-13 Front Panel... 4-14 Membrane Keyboard... 4-14 Power Switch... 4-14 REM Connector/Switch... 4-14 CEM Mechanism Switch... 4-14 Display Board... 4-15 RF Indicator Lamps... 4-15 REM Indicators... 4-15 LED and Seven-Segment Display Drivers... 4-15 CEM Switch Circuit... 4-16 Mode Selection and Power Control Switches... 4-16 Footswitch Board... 4-17 Footswitch Decode Circuit... 4-17 Audio Circuit... 4-18 Power Supply/RF Board... 4-19 Power Supply/RF Board Interfaces... 4-19 High Voltage Power Supply... 4-20 Low Voltage Power Supply... 4-22 RF Output Stage... 4-23 Spark Control Circuit... 4-26 RF Leakage Reduction Circuit... 4-26 REM Circuit... 4-27 IsoBloc Circuit... 4-27 Temperature Sense Circuits... 4-28 Autobipolar Board... 4-29 80 kHz Signal Generator... 4-29 Tissue Impedance Sense Circuit... 4-29

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Analog Detection Circuit... 4-30

Chapter 5. Setup, Tests, and Adjustments Setting Up the Generator... 5-2 Connections for Bipolar or Macrobipolar Surgery... 5-3 Setting the Bipolar Output... 5-5 Connections for Monopolar Surgery... 5-5 Selecting Cut and Coag Modes... 5-8 Changing the Desiccate Mode... 5-8 Simultaneous Coag... 5-9 Using Two Generators Simultaneously... 5-10 Connecting the CUSA Handpiece with CEM Nosecone . . 5-10 Setting the Output Power... 5-11 Simultaneous Coag with a CUSA System... 5-11 Changing the Mode... 5-11 Changing the Power Setting... 5-12 Activating the Surgical Instrument... 5-12 Autobipolar Activation... 5-12 Autobipolar Setup Mode... 5-14 Access the Autobipolar Setup Mode... 5-14 Select the Activation Source... 5-14 Adjust the Activation Delay Time... 5-15 Select the Deactivation Impedance Level... 5-15 Periodic Safety Check... 5-17 Recommended Test Equipment... 5-18 Inspecting the Generator and Accessories... 5-18 Inspecting the Internal Components... 5-20 Testing the Generator... 5-21 Verifying REM Function... 5-22 Confirming Outputs... 5-23 Checking the Bipolar Output... 5-23 Checking Output for the Monopolar Cut Modes... 5-24 Checking Output for the Monopolar Coag Modes... 5-25 Checking the Autobipolar Feature... 5-25 Checking Low Frequency Leakage Current and Ground Resistance... 5-27 Checking High Frequency Leakage Current... 5-28 Calibrating the Generator... 5-30 Preparing for Calibration... 5-31 Entering Calibration Mode... 5-31

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Exiting Calibration Mode... 5-32 Verify the Generator Data... 5-32 Adjust the Calendar... 5-33 Adjust the Clock... 5-34 Check and Adjust the REM Oscillator Frequency and Impedance... 5-34 Check and Adjust the Current Sense Gain... 5-35 Check and Adjust the Voltage Sense Gain... 5-37 Check and Adjust the Reactance Gain... 5-40 Checking the Reactance Gain for Monopolar Output . . . 5-41 Check and Adjust the ECON Factor... 5-42 Check and Adjust the Autobipolar Oscillator Frequency and Impedance... 5-46 Using the RS-232 Serial Port... 5-48 Establish the Communications Link... 5-48 Enter the Commands... 5-49 Disconnect the Computer from the Generator... 5-55

Chapter 6. Troubleshooting Inspecting the Generator... 6-2 Inspecting the Receptacles... 6-2 Inspecting the Internal Components... 6-3 Correcting Malfunctions... 6-4 Responding to System Alarms... 6-12 Correcting T_ON ASIC Malfunctions... 6-28 Correcting Battery-Backed RAM Malfunctions... 6-30

Chapter 7. Replacement Procedures Interconnect Diagram... 7-2 Battery Replacement... 7-3 Control Board Replacement... 7-4 Display Board Replacement... 7-5 Remove the Display Board... 7-5 Install the Display Board... 7-6 Display Board Seven-Segment LED Replacement... 7-7 Autobipolar Board Replacement... 7-8 Fan Replacement... 7-9 Footswitch Board Replacement... 7-9 Front Panel Replacement... 7-10 Remove the Front Panel Assembly... 7-10 Remove and Reinstall the Front Panel Components... 7-10

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Install the Front Panel Assembly... 7-11 Front Panel REM Module Replacement... 7-12 Front Panel Power Switch Replacement... 7-13 Fuse Replacement... 7-14 Replacing Fuses in the Fuse Drawer... 7-14 Replacing the Fuse on the Power Supply/RF Board... 7-15 Left Front Heat Sink and Component Replacement... 7-16 Remove the Left Front Heat Sink... 7-16 Replace Left Front Heat Sink Components... 7-17 Install the Left Front Heat Sink... 7-17 Left Rear Heat Sink and Component Replacement... 7-18 Remove the Left Rear Heat Sink... 7-18 Replace Left Rear Heat Sink Components... 7-19 Install the Left Rear Heat Sink... 7-19 Right Heat Sink and Component Replacement... 7-20 Remove the Right Heat Sink... 7-20 Replace Right Heat Sink Components... 7-21 Install the Right Heat Sink... 7-22 Low Voltage Power Supply Replacement... 7-23 Remove the Low Voltage Power Supply... 7-23 Install the Low Voltage Power Supply... 7-24 Power Entry Module Replacement... 7-26 Remove the Power Entry Module... 7-26 Install the Power Entry Module... 7-26 Power Supply/RF Board Replacement... 7-28 Remove the Power Supply/RF Board Assembly... 7-28 Remove Components from the Old Board... 7-29 Install Components on the New Board... 7-30 Install the Power Supply/RF Board Assembly... 7-31

Chapter 8. Repair Policy and Procedures Responsibility of the Manufacturer... 8-2 Returning the Generator for Service... 8-2 Obtain a Return Authorization Number... 8-2 Clean the Generator... 8-3 Ship the Generator... 8-3 Returning Circuit Boards... 8-3 Technical Service... 8-3 Training/Education... 8-4

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Chapter 9. Service Parts Ordering Replacement Parts... 9-2 Generator Assembly... 9-3 Parts List... 9-5 Front Panel Assembly... 9-7 Parts List... 9-9 Control Board Components... 9-10 Autobipolar Board Components... 9-10 Display Board Components... 9-13 Footswitch Board Components... 9-16 Power Supply/RF Board Assembly... 9-19 Parts List... 9-21 Supply/RF Board Components... 9-24

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Chapter 1 Introduction This manual provides instructions for servicing the Covidien Force FX Electrosurgical Generator 8CAS with Instant ResponseTM technology. This chapter introduces the features and components of the generator and reviews the precautions associated with generator repair.

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General Description

General Description The Force FX Electrosurgical Generator 8CAS-also referred to in this manual as Force FX-8CAS generator-is an isolated output electrosurgical generator that provides the appropriate power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. It includes the following features: • Instant Response technology • Three bipolar modes: precise (low), standard (medium), and macro (macrobipolar) • Autobipolar mode • Three monopolar cut modes: low, pure, and blend • Three monopolar coag modes: desiccate (low), fulgurate (medium), and spray (high) • Support for simultaneous coagulation • The Covidien REMTM Contact Quality Monitoring System • Support for ultrasonic electrosurgery using the CUSA EXcel system and a CUSA handpiece with a CUSA electrosurgical module (CEM ) nosecone TM*

TM*

TM*

• Handswitch or footswitch activation • Recall of most recently used mode and power settings • Adjustable activation tone volume • An RF activation port, RS-232 serial port, and expansion port • ValleylabTM Argon Gas Delivery Unit II compatibility

List of Components The Force FX-8CAS generator is a self-contained unit, consisting of a main enclosure (cover and base) and power cord. The main components of the generator are the following: • Front panel components-power switch; controls for setting the modes and output power; a button for recalling the power settings and modes that were used last; receptacles for connecting electrosurgical accessories; and indicators that alert you to the current settings and patient return electrode status. • Rear panel components-volume control; three footswitch receptacles; power entry module; equipotential grounding lug; and three ports (serial port, RF activation port, and expansion port). • Internal components-Control (microcontroller) board; Display board; Footswitch board; Power Supply/RF board; autobipolar board, low voltage power supply; fan; and heat sinks.

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Service Personnel Safety

For details about the interaction of the main components and circuit board descriptions, refer to Chapter 4, Principles of Operation.

Introduction

A handle is located on the underside of the chassis.

Service Personnel Safety Before servicing the generator, it is important that you read, understand, and follow the instructions supplied with it and with any other equipment used to install, test, adjust, or repair the generator.

General Warning Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result. The instrument receptacles on this generator are designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments.

Precaution Do not stack equipment on top of the generator or place the generator on top of electrical equipment (except an Argon Gas Delivery Unit II or a CUSA EXcel unit). These configurations are unstable and/or do not allow for adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause interference with them. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active.

Notice If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage may result.

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Service Personnel Safety

Active Accessories Warning Electric Shock Hazard Do not connect wet accessories to the generator. Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

Precaution Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar Instrument receptacle only. Improper connection may result in inadvertent generator activation or a REM Contact Quality Monitor alarm. Set power levels to the lowest setting before testing an accessory

Notice During bipolar electrosurgery, do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

Patient Return Electrodes Warning Using a patient return electrode without the REM safety feature will not activate the REM Contact Quality Monitoring System.

Fire/Explosion Hazards Warning Danger: Explosion Hazard Do not install the generator in the presence of flammable anesthetics, gases, liquids, or objects. Fire Hazard Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. Use a holster to hold electrosurgical accessories safely away from personnel and flammable materials. Fire Hazard Do not use extension cords. Fire Hazard For continued protection against fire hazard, replace fuses only with fuses of the same type and rating as the original fuse.

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Service Personnel Safety

Warning Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters

Introduction

Electric Shock Hazards

Do not connect a wet power cord to the generator or to the wall receptacle. To allow stored energy to dissipate after power is disconnected, wait at least five minutes before replacing parts. Always turn off and unplug the generator before cleaning. Do not touch any exposed wiring or conductive surfaces while the generator is disassembled and energized. Never wear a grounding strap when working on an energized generator. When taking measurements or troubleshooting the generator, take appropriate precautions, such as using isolated tools and equipment, using the “one hand rule,” etc. Potentially lethal AC and DC voltages are present in the AC line circuitry, high voltage DC circuitry, and associated mounting and heat sink hardware described in this manual. They are not isolated from the AC line. Take appropriate precautions when testing and troubleshooting this area of the generator. High frequency, high voltage signals that can cause severe burns are present in the RF output stage and in the associated mounting and heat sink hardware described in this manual. Take appropriate precautions when testing and troubleshooting this area of the generator.

Servicing Precaution Read all warnings, cautions, and instructions provided with this generator before servicing. The generator contains electrostatic-sensitive components. When repairing the generator, work at a static-control workstation. Wear a grounding strap when handling electrostatic-sensitive components, except when working on an energized generator. Handle circuit boards by their nonconductive edges. Use an antistatic container for transport of electrostatic-sensitive components and circuit boards.

Notice After installing a new low voltage power supply, verify that the voltages are correct.

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Service Personnel Safety

Calibration Precaution To avoid inadvertent coupling and/or shunting of RF currents around the resistor elements, keep the resistors at least 4" (10.2 cm) away from any metal surface including tabletops and other resistors. This is especially true if several resistors are connected in series or parallel to obtain a specified value. Do not allow the resistor bodies to touch each other

Notice After completing any calibration step, proceed to the next step to save the values from the completed calibration step. Do not activate the generator with any load resistor higher than 10 ohms (10 Ω) while calibrating the current sense gain. Otherwise, product damage will result. Do not activate the generator with any load resistor lower than 1000 Ω while calibrating the voltage sense gain for bipolar output. Otherwise, product damage will result. Do not activate the generator with any load resistor lower than 3000 Ω while calibrating the voltage sense gain for the Low and Pure cut modes. Do not activate the generator with any load resistor lower than 2000 Ω while calibrating the voltage sense gain for the Blend mode. Otherwise, product damage will result. Do not adjust the current sense gain (I factor), the voltage sense gain (V factor), or the reactance gain (Z factor) while the generator is activated. After calibration, the generator will be ready to use only after you initiate the internal self-test by turning the generator off, then on. Calibrate the generator after you install a new battery. Calibration values are lost when the battery is replaced. Calibrate the generator after you install a new Control board. Otherwise, the default calibration values are used. Calibrate the generator after you install a new heat sink or replace components on the heat sink. Component differences may affect output waveforms. Calibrate the generator after you install a new Power Supply/RF board. Component differences may affect output waveforms.

Cleaning Notice Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.

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