Force EZ Generator CS Users Guide Feb 2011

User’s Guide TM

Force EZ

Electrosurgical Generator CS

1013089

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 Frame EZTM Electrosurgical Generator CS only. Additional information is available in the Frame EZ Electrosurgical Generator CS/8CS Service Manual. Equipment covered in this manual: Frame EZ Electrosurgical Generator CS 100–120 V ~ (110 V ~ nominal), 220–240 V ~ (230 V ~ nominal) – (user selectable)

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. Caution 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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Force EZ Electrosurgical Generator CS User’s Guide

Limited Warranty Covidien warrants each 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 periods for Covidien products are as follows:

ForceTriadTM Energy Platform

One year from date of shipment

Electrosurgical Generators

One year from date of shipment

Cool-tipTM RFA Generator

One year from date of shipment

RFG-3CTM Plus Lesion Generator

One year from date of shipment

LigaSureTM Vessel Sealing System

One year from date of shipment

LigaSureTM Reusable Instruments

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

ValleylabTM Argon Gas Delivery Unit II

One year from date of shipment

RapidVacTM Smoke Evacuator

One year from date of shipment

LigaSureTM Sterile Single Use Items

Sterility only as stated on packaging

Cool-tipTM Sterile Single Use Items

Sterility only as stated on packaging

Sterile Single Use Items

Sterility only as stated on packaging

Patient 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.

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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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Table of Contents Preface... ii Conventions Used in this Guide... ii Limited Warranty... iii

Chapter 1. Introduction Overview... 1-2 Instant Response Technology... 1-2 Bipolar Modes... 1-3 Monopolar Cut and Coag Modes... 1-3 Cut Modes... 1-3 Coag Modes... 1-3 REM Contact Quality Monitoring System... 1-4 How the REM System Works... 1-4 Electrodes Without the REM Safety Feature... 1-4 Special Features... 1-5 Low (Desiccate) Coag Settings... 1-5 High (Fulgurate) Coag Settings... 1-5 Recall of Most Recently Used Modes and Power Settings... 1-5 Default Coag Mode... 1-5 Original Default Settings... 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 Monopolar Footswitching Accessory Receptacle... 2-7 Monopolar Footswitching or Handswitching Instrument Receptacle... 2-7 REM Alarm Indicator... 2-8 Rear Panel... 2-9 Footswitch Receptacles... 2-10 Monopolar Footswitch Receptacle... 2-10 Bipolar Footswitch Receptacle... 2-10 Power Entry Module... 2-11 Activation Tone Volume Control... 2-11 Option Panel... 2-12

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Chapter 3. Patient and Operating Room Safety General... 3-2 Fire/Explosion... 3-3 Fire Hazard with Oxygen Circuit Connections... 3-3 Electrosurgical Smoke... 3-3 Inadvertent Radio Frequency Burns... 3-4 Ensure Proper Connections... 3-4 Accessories... 3-5 Servicing... 3-5 Before Surgery... 3-6 Active Accessories... 3-6 Patient Return Electrodes... 3-6 Shunt Cords... 3-7 Generator... 3-7 During Surgery... 3-8 Generator Power Settings... 3-8 Forceps... 3-8 Suction Coagulators... 3-9 Contact with Metal Objects... 3-9 Active Accessories... 3-10 Patient Return Electrodes... 3-10 Laparoscopic Procedures... 3-11 After Surgery... 3-12

Chapter 4. Before Surgery Quick Setup Instructions... 4-2 Setting Up the Generator... 4-3 Preparing for Bipolar Surgery... 4-5 Connections for Bipolar Surgery... 4-5 Setting the Bipolar Output... 4-7 Preparing for Monopolar Surgery... 4-8 Connections for Monopolar Surgery... 4-8 Applying a Patient Return Electrode to the Patient... 4-10 Pacemakers... 4-11 Selecting Cut and Coag Modes... 4-12 Setting the Cut and Coag Output... 4-12 Setting Up the Special Features... 4-13 Entering the Setup Mode... 4-13 Exiting the Setup Mode... 4-14

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Chapter 5. During Surgery Checking Accessory Connections... 5-2 Checking the Patient Return Electrode... 5-2 Changing the Mode... 5-2 Selecting the Power Setting... 5-3 Changing the Power Setting... 5-3 Techniques for Keeping Power Settings Low... 5-4 Typical Power Settings... 5-4 Activating the Surgical Instrument... 5-5 Activation Indicators... 5-6 Adjusting the Volume of Activation Tones... 5-6 Responding to Alarms... 5-7 REM Alarm... 5-7 Non-REM Patient Return Electrode Alarm... 5-7 System Alarm... 5-7 Calling the Covidien Clinical Information Hotline... 5-8

Chapter 6. After Surgery Preparing the Generator for Reuse... 6-2 Step 1 – Disconnect the Accessories... 6-2 Step 2 – Clean the Generator... 6-2 Storing the Generator... 6-2

Chapter 7. Troubleshooting General Troubleshooting Guidelines... 7-2 Correcting a REM Alarm Condition... 7-2 Checking for Obvious Problems... 7-2 Performing a Detailed Inspection... 7-3 Applying Additional REM Polyhesive Patient Return Electrodes... 7-3 Correcting Malfunctions... 7-6 Responding to System Alarms... 7-12

Chapter 8. Maintenance and Repair Responsibility of the Manufacturer... 8-2 Routine Maintenance... 8-2 Returning the Generator for Service... 8-3 Step 1 – Obtain a Return Authorization Number... 8-3 Step 2 – Clean the Generator... 8-3 Step 3 – Ship the Generator... 8-4 Service Center... 8-4

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Chapter 9. Technical Specifications Performance Characteristics... 9-2 General... 9-2 Dimensions and Weight... 9-2 Operating Parameters... 9-2 Transport and Storage... 9-3 Duty Cycle... 9-3 Internal Memory... 9-4 Audio Volume... 9-4 REM Contact Quality Monitor... 9-5 Serial Port... 9-6 RF Activation Port... 9-6 Low Frequency (50–60 Hz) Leakage Current... 9-6 High Frequency (RF) Leakage Current... 9-6 Input Power... 9-7 Power Cord Specification... 9-8 Standards and IEC Classifications... 9-9 Class I Equipment (IEC 60601-1)... 9-9 Type CF Equipment (IEC 60601-1)/Defibrillator Proof... 9-10 Liquid Spillage (IEC 60601-2-2 Clause 44.3)... 9-10 Electromagnetic Interference... 9-10 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)... 9-10 Voltage Transients (Emergency Generator Mains Transfer)... 9-11 Output Characteristics... 9-11 Maximum Output for Force EZ-CS Generator Modes... 9-11 Available Power Settings in Watts... 9-12 Output Waveforms... 9-14 Output Power vs. Resistance Graphs... 9-15 Bipolar Graph... 9-15 Monopolar Cut Graphs... 9-17 Monopolar Coag Graphs... 9-19 Output Power vs. Generator Settings... 9-24

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Chapter 1 Introduction This chapter includes the following information: • Instant Response technology • Bipolar modes • Monopolar cut and coag modes • REM Contact Quality Monitoring System • Special features of the Force EZ-CS generator

Caution Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual.

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Overview

Overview The Covidien Force EZ Electrosurgical Generator CS-also called the Force EZ-CS generator in this manual-is an isolated output electrosurgical generator that provides power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. It includes the following features: • Instant ResponseTM technology • Standard bipolar mode • Two monopolar cut modes: pure and blend • Two monopolar coag modes: low (desiccate) and high (fulgurate) • The REM Contact Quality Monitoring System • Handswitch or footswitch activation • User selectable coag settings • User selectable default settings • Adjustable activation tone volume • An RF activation port and RS-232 serial port • Argon Gas Delivery Unit II system compatibility • Tilt support provided by the bottom mounted handle or use with Covidien carts Covidien electrosurgical generators, patient return electrodes, and active accessories are designed to work as a system. Covidien offers a selection of patient return electrodes and electrosurgical instruments that are fully compatible with this generator. When considering other manufacturer’s patient return electrodes and/or active accessories, customers should seek detailed user instructions and warning information from the manufacturer.

Instant Response Technology The Force EZ-CS generator automatically senses resistance and adjusts the output voltage, current, and power to maintain a consistent effect across different tissue density. This adjustment is based on the selected mode, power setting, and level of tissue resistance. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking. This technology applies to the standard bipolar mode, the cut modes, and the low 2 and low 3 coag settings. It does not apply to the low 1, high 1, and high 2 coag settings.

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Force EZ Electrosurgical Generator CS User’s Guide

Bipolar Modes

The Force EZ-CS generator provides a standard bipolar mode usable for most bipolar applications. Delicate tissue requires less heat to desiccate quickly. The generator provides low voltage, continuous current for faster desiccation without sparking.

Introduction

Bipolar Modes

The possibility of sparking increases as desiccated tissue dries and becomes more resistant. The generator protects against sparking by limiting the bipolar voltage at relatively high levels of tissue resistance. For details about the bipolar output characteristics, refer to Chapter 9, Technical Specifications.

Monopolar Cut and Coag Modes Cut Modes Two cut modes-pure and blend-allow a wide range of power settings necessary to perform diverse surgical procedures. • Pure provides an even cut with little or no hemostasis. It offers good cutting performance over a wide range of tissue resistance • Blend provides cutting ability with additional hemostasis

Coag Modes Two coagulation modes help control the size of the area and the depth of penetration during tissue coagulation. The low (desiccate) mode has three settings; the high (fulgurate) mode, two settings. You can select, as default settings, one low setting and one high setting. For a description of each setting, refer to Special Features on page 1-5. • Low (desiccate) dehydrates and destroys tissue without sparking or cutting. Because the active electrode directly touches the tissue, more current reaches the patient. Desiccation places the greatest demand on the patient return electrode. • High (fulgurate) coagulates tissue by sparking from the active electrode, through air, to the patient tissue. Since sparks may spray unpredictably from the electrode during fulguration, using fulguration for delicate tissue or in confined areas can complicate surgery. Accidental sparking to adjacent areas can occur as tissue at the surgical site dries and becomes more resistant to current flow. For details about the output characteristics, refer to Chapter 9, Technical Specifications.

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REM Contact Quality Monitoring System

REM Contact Quality Monitoring System During monopolar electrosurgery, a patient return electrode is always required to safely recover the current that flows through the patient’s body and return it to the generator. A reduction in surface area contact or poor conductivity between the patient and the return electrode can cause the current to become concentrated, potentially resulting in burns at the return electrode site. The Force EZ-CS generator uses the REM Contact Quality Monitoring System to monitor the quality of electrical contact between the patient return electrode and the patient. The REM system is designed to minimize the risk of burns at the return electrode site due to a reduction in patient contact area during monopolar electrosurgery. Use of any return electrode other than a REM PolyhesiveTM patient return electrode may compromise the REM safety feature. This could result in a patient burn.

How the REM System Works TM

The REM system continuously measures the resistance at the return electrode site and compares it to a standard range of safe resistance (between 5 and 135 ohms), thus eliminating intermittent false alarms that could result from small changes in resistance. The REM system also adapts to individual patients by measuring the initial contact resistance between the patient and the patient return electrode and lowering the baseline resistance if the contact resistance drops. A REM alarm sounds and the generator stops producing output power when either of the following occurs: • The measured resistance is below 5 ohms or above 135 ohms, the limits of the standard range of safe resistance • An increase in contact resistance is greater than 40% from the baseline measurement

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

When you use a patient return electrode that does not have the REM safety feature, the REM system cannot monitor the patient contact area as previously described. The REM system can monitor only the pin-to-pin resistance at the connector and can detect broken wires or connectors in the return electrode cord.

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Force EZ Electrosurgical Generator CS User’s Guide

Special Features

Five special features allow customizing the Force EZ-CS generator. You can access these features only in the setup mode. For details on selecting these features, refer to Setting Up the Special Features on page 4-13.

Introduction

Special Features

Low (Desiccate) Coag Settings The low (desiccate) coag mode provides three settings with subtle differences in output characteristics: • Low 1 is appropriate for the majority of surgical procedures. It provides tissue desiccation with a minimal tendency to cut or spark. • Low 2 produces tissue desiccation and further reduces the chance of cutting or sparking by using the lowest possible voltage (200 Vrms). • Low 3 uses a slightly higher voltage (300 Vrms) than the low 2 setting, but offers comparable desiccation.

High (Fulgurate) Coag Settings The high (fulgurate) coag mode provides two settings: • High 1 produces coagulation of smaller areas without touching the electrode tip to the tissue. • High 2 produces coagulation of larger areas without touching the electrode tip to the tissue.

Recall of Most Recently Used Modes and Power Settings When you activate this feature, the generator will, when turned on, revert to the most recently used modes and power settings.

Default Coag Mode Important The default coag mode feature is available only when the most recently used modes and power settings feature is turned off

You can select either low (desiccate) or high (fulgurate) as the default coag mode for the Force EZ-CS generator. Each time you turn on the generator, it automatically selects the default coag mode.

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Special Features

Original Default Settings This feature resets the generator to the original default setting for each mode, power setting, and special feature. The next time you turn on the generator, it automatically selects the original default settings.

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Mode or Feature

Original Default Setting

Monopolar

Pure

Coag

High (fulgurate)

Low (desiccate) coag setting

1 (low 1)

High (fulgurate) coag setting

2 (high 2)

Last used modes and power settings

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Force EZ Electrosurgical Generator CS User’s Guide

Chapter 2 Controls, Indicators and Receptacles This chapter describes the front and rear panels, including all controls, indicators, receptacles, the fuse drawer, and ports.

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Front Panel

Front Panel Footswitch indicators

Bipolar controls

Cut controls

Footswitch selector button Bipolar instrument receptacle

REM alarm indicator

Coag controls

Monopolar footswitching accessory receptacle

Footswitch receptacle

Power switch This switch supplies power to the generator.

Monopolar footswitching or handswitching instrument receptacle

Patient return electrode receptacle For monopolar electrosurgery, connect a patient return electrode to this receptacle.

To turn on the generator, press (|). To turn off the generator, press (O).

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Force EZ Electrosurgical Generator CS User’s Guide

Bipolar Controls

Bipolar Controls Bipolar display Shows the power setting, in watts, for standard bipolar mode.

Bipolar indicator When you activate bipolar, this bar illuminates blue and an activation tone sounds.

Controls, Indicators and Receptacles

Bipolar Power Control Knob To increase (+) the power, turn the knob clockwise. To decrease (–) the power, turn the knob counterclockwise.

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Bipolar Instrument Receptacle

Bipolar Instrument Receptacle Caution 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.

You can connect either a footswitching or handswitching bipolar instrument to the Bipolar instrument receptacle.

Connect a footswitching instrument with a two-pin connector. or Connect a handswitching instrument with a three-pin connector.

Footswitch Receptacle, Button, and Indicators Connect a two-pedal Valleylab monopolar footswitch to this receptacle. Press the Footswitch Selector button to select bipolar or accessory output.

Use only a Valleylab monopolar footswitch with the Force EZ-CS generator. Use of an incompatible footswitch may cause unexpected output. When the left arrow indicator illuminates green, the footswitch activates the instrument connected to the Bipolar Instrument receptacle.

When the right arrow indicator illuminates green, the footswitch activates the instrument connected to the Monopolar Footswitching Accessory receptacle. The footswitch will not activate an instrument connected to the Monopolar Footswitching or Handswitching Instrument receptacle.

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Monopolar Cut Controls

Monopolar Cut Controls Cut indicator When you activate cut, this bar illuminates yellow and an activation tone sounds.

Cut display Shows the power setting, in watts, for cut output.

Blend Button Select for slower cutting and additional hemostasis.

Controls, Indicators and Receptacles

Pure Button Select for an even cut with little or no hemostasis.

Cut Power Control Knob To increase (+) the power, turn the knob clockwise. To decrease (–) the power, turn the knob counterclockwise.

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