Valleylab Force EZ User Manual

User’s Guide

Force EZ

Electrosurgical Generator C

1012744

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 EZ

Electrosurgical Generator C only. Additional information is available in the Frame EZ Electrosurgical Generator C Service Manual.

Equipment covered in this manual:

Frame EZ Electrosurgical Generator C 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.

ii Force EZ Electrosurgical Generator C 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-tip

RFG-3CTM Plus Lesion Generator One year from date of shipment

LigaSure

RFA Generator One year from date of shipment

Vessel Sealing System One year from date of shipment

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

Valleylab

RapidVac

LigaSure

Cool-tip

Argon Gas Delivery Unit II One year from date of shipment

Smoke Evacuator One year from date of shipment

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.

Force EZ Electrosurgical Generator C User’s Guide iii

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.

iv Force EZ Electrosurgical Generator C User’s Guide

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

Force EZ Electrosurgical Generator C User’s Guide v

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

vi Force EZ Electrosurgical Generator C User’s Guide

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

Force EZ Electrosurgical Generator C User’s Guide vii

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-C 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

viii Force EZ Electrosurgical Generator C User’s Guide

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-C 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.

Force EZ Electrosurgical Generator C User’s Guide 1-1

Overview

The Covidien Force EZ Electrosurgical Generator C—also called the Force EZ-C 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 Response

• 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

technology

• 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-C 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.

1-2 Force EZ Electrosurgical Generator C User’s Guide

Bipolar Modes

The Force EZ-C 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.

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

Bipolar Modes

Introduction

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.

Force EZ Electrosurgical Generator C User’s Guide 1-3

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-C 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 Polyhesive compromise the REM safety feature. This could result in a patient burn.

How the REM System Works

patient return electrode may

The REMTM 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.

1-4 Force EZ Electrosurgical Generator C User’s Guide

Special Features

Five special features allow customizing the Force EZ-C 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.

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 V

• Low 3 uses a slightly higher voltage (300 V comparable desiccation.

rms

) than the low 2 setting, but offers

rms

Special Features

Introduction

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-C 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.

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 1 (on)

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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

Bipolar controls Cut controls

Bipolar instrument receptacle

Power switch

This switch supplies power to the generator.

Footswitch selector button

Footswitch receptacle

Footswitch indicators

Monopolar footswitching accessory receptacle

Coag controls

Monopolar footswitching or handswitching instrument receptacle

REM alarm

indicator

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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Bipolar Controls

Bipolar display

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

Bipolar Controls

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

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.

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-C 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

Cut display

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

Cut indicator

When you activate cut, this bar illuminates yellow and an activation tone sounds.

Cut Power Control Knob

To increase (+) the power, turn the knob clockwise.

To decrease (–) the power, turn the knob counterclockwise.

Pure Button

Select for an even cut with little or no hemostasis.

Blend Button

Select for slower cutting and additional hemostasis.

Controls, Indicators and

Receptacles

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Monopolar Coag Controls

Coag display

Shows the power setting, in watts, for coag output.

Coag indicator

When you activate the generator in coag mode, this bar illuminates blue and an activation tone sounds.

Low (Desiccate) Button

Select to desiccate the area of tissue that is in direct contact with the active electrode.

High (Fulgurate) Button

Select to fulgurate an area of tissue with a spray of sparks.

Coag Power Control Knob

To increase (+) the power, turn the knob clockwise.

To decrease (–) the power, turn the knob counterclockwise.

2-6 Force EZ Electrosurgical Generator C User’s Guide

Monopolar Instrument Receptacles

Warning

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.

Monopolar Footswitching Accessory Receptacle

Connect a monopolar footswitching instrument with a single-pin connector to this receptacle.

To activate the instrument, connect a monopolar footswitch to the front panel.

Monopolar Footswitching or Handswitching Instrument Receptacle

You can connect either a handswitching instrument (three-pin connector) or a footswitching instrument (single-pin connector) to this receptacle.

Controls, Indicators and

Receptacles

To activate a footswitching instrument, connect a monopolar footswitch to the rear panel.

Some footswitching instruments may require a single-pin adapter (E0502 Series) or E0017, available from Covidien.

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REM Alarm Indicator

This indicator illuminates red until you properly apply a REM Polyhesive patient return electrode to the patient and connect it to the generator. Then the indicator illuminates green. (When you connect an electrode without the REM safety feature, the indicator does not illuminate.)

If the REM system senses an alarm condition, the indicator flashes red until you correct the alarm condition—then the indicator illuminates green. (If you are using a return electrode without the REM safety feature, the red indicator light is extinguished when you correct the alarm condition.)

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Rear Panel

Vol ume control

Bipolar Footswitch receptacle

Monopolar Footswitch receptacle

Power entry module

Controls, Indicators and

Receptacles

Option panel

Equipotential grounding lug

Use to connect the generator to earth ground.

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Footswitch Receptacles

Monopolar Footswitch Receptacle

Connect a two-pedal Valleylab monopolar footswitch to this receptacle if you connect an instrument to the Monopolar Footswitching or Handswitching Instrument receptacle on the front panel.

Use only a Valleylab monopolar footswitch with the Force EZ-C generator. Use of an incompatible footswitch may cause unexpected output.

The footswitch will not activate instruments connected to the Bipolar Instrument or Monopolar Footswitching Accessory receptacles on the front panel.

Bipolar Footswitch Receptacle

Connect a single-pedal bipolar footswitch to this receptacle if you connect an instrument to the Bipolar Instrument receptacle on the front panel.

The footswitch will not activate instruments connected to the Monopolar Instrument or Monopolar Footswitching Accessory receptacles on the front panel.

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Power Entry Module

The power entry module consists of a power cord receptacle and a fuse drawer.

Fuse drawer

The fuse drawer contains two fuses. Refer to the Force EZ Electrosurgical Generator C/8C Service Manual for instructions on changing the fuses.

Power cord receptacle

Activation Tone Volume Control

Power Entry Module

Controls, Indicators and

Receptacles

Turn to adjust the volume of the tones that sound when the generator is activated (activation tone). To ensure that the surgical team is alerted to inadvertent activation, these tones cannot be silenced.

To increase the volume of activation tones, turn the knob clockwise.

To decrease the volume, turn the knob counterclockwise.

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Option Panel

A removable plate on the rear panel covers a serial port and an RF (radio frequency) activation port. Remove this plate to obtain information through the RS-232 port or to install a peripheral device such as a Bipolar Current Monitor, but retain the original cover plate. After obtaining information or removing a peripheral device, reinstall the original cover plate.

To review the technical specifications for each port, refer to Chapter 9, Technical Specifications.

RF Activation port

Allows a connected device to receive information during RF activation of the generator, which will then generate a response in the device.

Serial port

Allows connection of a computer to the generator. You can obtain information about the generator using RS-232 communications protocol. Refer to the Force EZ Electrosurgical Generator C/8C Service Manual.

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Chapter 3

Patient and Operating Room Safety

The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant surgical team. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, understood, and followed.

Electrosurgery has been used safely in numerous procedures. Before starting any surgical procedure, the surgeon should be trained in the particular technique and surgical procedure to be performed, should be familiar with the medical literature related to the procedure and potential complications, and should be familiar with the risks versus the benefits of utilizing electrosurgery in the procedure.

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General

Warning

Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken. Use by physicians without such training has resulted in serious, unintended patient injury, including bowel perforation and unintended, irreversible tissue necrosis.

Hazardous Electrical Output This equipment is for use only by trained, licensed physician

Always use the lowest output setting necessary that achieves the desired surgical effect. The active electrode should be utilized only for the minimum time necessary in order to lessen the possibility of unintended burn injury. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small structures.

Use electrosurgery with caution in the presence of internal or external pacemakers. Interference produced by the use of electrosurgical devices can cause devices such as a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers.

If the patient has an internal cardiac defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple activations of ICDs.

Covidien recommends against performing laparoscopic surgery on pregnant patients.

Caution

Read all warnings, cautions, and instructions provided with this generator before using.

For surgical procedures where the current could flow through delicate parts of the body, the use of bipolar techniques may be desirable in order to avoid unwanted coagulation.

Always use the lowest output setting that achieves the desired surgical effect. The active electrode should be utilized only for the minimum time necessary in order to lessen the possibility of unintended burn injury. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small appendages.

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Fire/Explosion

Warning

Danger: Explosion Hazard Do not use electrosurgery in the presence of flammable

anesthetics.

Fire/Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room:

• Flammable substances (such as alcohol based skin prepping agents and tinctures)

• Naturally occurring flammable gases which may accumulate in body cavities such as the bowel

• Oxygen enriched atmospheres

• Oxidizing agents (such as nitrous oxide [

The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed.

N2O] atmospheres).

General

Fire Hazard with Oxygen Circuit Connections

Warning

Fire/Explosion Hazard Verify that all oxygen circuit connections are leak free before and during

the use of electrosurgery. Verify that endotracheal tubes are leak free, and that the cuff is properly sealed to prevent oxygen leaks. Enriched oxygen atmospheres may result in fires and burns to patients or the surgical team.

Electrosurgical Smoke

Caution

Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means.

a. U.S. Department of Health and Human Services. National Institute for Occupational Safety and

Health (NIOSH). Control of Smoke from Laser/Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September, 1996.

Patient and Operating Room

Safety

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General

Inadvertent Radio Frequency Burns

Warning

Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at 50-60 Hz, insulated, and/or battery operated.

To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe site, place the electrode and/or probe as far away as possible from the electrosurgical site and/or patient return electrode. Protective impedances (resistors or RF inductors) installed in the monitoring leads may reduce the risk of such burns. Consult the hospital biomedical engineer for further information.

Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result.

In some circumstances, potential exists for alternate site burns at points of skin contact (e.g., between the arm and the side of the body). This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point. Current passing through small skin to skin contact points is concentrated and may cause a burn. This is true for grounded, ground referenced, and isolated output generators.

To reduce the potential for alternate site burns, do one or more of the following:

• Avoid skin-to-skin contact points, such as fingers touching leg, when positioning the patient.

• Place five to eight centimeters (two to three inches) of dry gauze between contact points to ensure that contact does not occur.

• Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin-to-skin contact areas.

• In addition, place patient return electrodes according to the manufacturer’s instructions.

Potential for alternate site burns increases if the return electrode is compromised. Covidien recommends the use of REM Polyhesive patient return electrodes and Covidien generators with the REM system.

Ensure Proper Connections

Caution

Examine all accessories and connections to the electrosurgical generator before using. Ensure that the accessories function as intended. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects.

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