Valleylab Force EZ User Manual

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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.

Force EZ Electrosurgical Generator C User’s Guide 1-5

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)

1-6 Force EZ Electrosurgical Generator C 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.

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

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).

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

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.

Force EZ Electrosurgical Generator C User’s Guide 2-3

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.

2-4 Force EZ Electrosurgical Generator C User’s Guide

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

Force EZ Electrosurgical Generator C User’s Guide 2-5

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.

Force EZ Electrosurgical Generator C User’s Guide 2-7

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.)

2-8 Force EZ Electrosurgical Generator C User’s Guide

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.

Force EZ Electrosurgical Generator C User’s Guide 2-9

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.

2-10 Force EZ Electrosurgical Generator C User’s Guide

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.

Force EZ Electrosurgical Generator C User’s Guide 2-11

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.

2-12 Force EZ Electrosurgical Generator C User’s Guide

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.

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

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.

3-2 Force EZ Electrosurgical Generator C User’s Guide

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

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

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.

3-4 Force EZ Electrosurgical Generator C User’s Guide

Accessories

Warning

Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.

Servicing

Warning

Electric Shock Hazard Do not remove the cover. Contact authorized personnel for service.

Notice

Refer to this generator’s service manual for maintenance recommendations and function and output power verification procedures.

General

Patient and Operating Room

Safety

Force EZ Electrosurgical Generator C User’s Guide 3-5

Before Surgery

Active Accessories

Warning

Electric Shock Hazard Do not connect wet accessories to the generator.

Connect accessories to the proper receptacle. Improper connection may result in inadvertent accessory activation or other potentially hazardous conditions. Follow the instructions provided with electrosurgical accessories for proper connection and use.

Electric Shock Hazard Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

Caution

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

Connect accessories to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar receptacle only. Improper connection of accessories may result in inadvertent generator activation or a REM Contact Quality Monitor alarm.

Set power levels to the lowest setting before testing an accessory.

Inspect accessories and cords (especially reusable accessories and cords) for breaks, cracks, nicks, and other damage before every use. If damaged, do not use. Failure to observe this precaution may result in injury or electrical shock to the patient or surgical team.

Do not reuse or resterilize accessories labeled “disposable” or “single use only.”

Patient Return Electrodes

Covidien recommends the use of REM Polyhesive patient return electrodes to maximize patient safety.

Warning

The safe use of monopolar electrosurgery requires proper placement of the patient return electrode. To avoid electrosurgical burns beneath the patient return electrode, follow all directions on the product package for proper return electrode placement and use.

Do not cut a patient return electrode to reduce its size. Patient burns due to high current density may result.

Do not apply a patient return electrode if only bipolar accessories are being used. Otherwise, the electrosurgical effect may not be limited to the tissue between the bipolar electrodes.

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

3-6 Force EZ Electrosurgical Generator C User’s Guide

Warning

Covidien recommends against the use of capacitive pads. These pads do not activate the REM Contact Quality Monitoring System and require the use of higher power settings to achieve the desired surgical effect. This increases the possibility of alternate site burns.

Shunt Cords

Warning

Some surgical instruments (e.g., colonoscopes) may allow substantial leakage current which could burn the surgeon. If the instrument manufacturer recommends the use of a shunt cord (s-cord) to direct the current back to the generator, you must also use a Covidien E0507B adapter. To avoid a REM alarm, you must use a REM Polyhesive patient return electrode with the E0507B adapter

Generator

Before Surgery

Warning

Patient Safety Use the generator only if the self-test has been completed as described.

Otherwise, inaccurate power outputs may result.

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

Fire Hazard Do not use extension cords.

Caution

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). These configurations are unstable and/or do not allow for adequate cooling.

When using a smoke evacuator in conjunction with the electrosurgical generator, place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard.

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.

Patient and Operating Room

Safety

Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active.

Nonfunction of the generator may cause interruption of surgery. A backup generator should be available for use.

Force EZ Electrosurgical Generator C User’s Guide 3-7

During Surgery

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.

During Surgery

Generator Power Settings

Warning

Confirm proper power settings before proceeding with surgery. Use the lowest power setting possible for the minimum time necessary to achieve the desired effect.

Never increase the power settings without first checking both the active electrode and the patient return electrode and their connections. Use the active electrode or forceps only for the minimum time necessary to achieve the desired surgical effect in order to minimize the possibility of burns. This is especially true in pediatric and neonatal patients or in any patient where small structures are involved.

Caution

The Force EZ-C generator cuts and coagulates (low 2 and low 3 settings only) effectively at power settings lower than previous models offered by Covidien. Fulguration is similar to previous models in effectiveness at a given power setting. If the proper setting is not known, set the generator at a very low setting and cautiously increase the power until the desired effect is achieved.

Forceps

Notice

Do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

3-8 Force EZ Electrosurgical Generator C User’s Guide

Suction Coagulators

Warning

To avoid the possibility of a burn to the surgeon, always turn the generator off before bending or reshaping the coagulator suction tube.

Ensure that the outside of the coagulator suction tube remains free of blood and mucus. Failure to clean the coagulator suction tube can allow electrical conductance by means of the contaminants that may result in patient burns.

Do not immerse the suction coagulator handswitch mechanism in saline solution or other conductive fluids. Unintended activation may result.

Contact with Metal Objects

Warning

Contact of the active electrode with any metal will greatly increase current flow and can result in unintended surgical effect.

During Surgery

While using electrosurgery, the patient should not be allowed to come into direct contact with grounded metal objects (e.g., surgical table frame, instrument table, etc.). If this is not possible during certain procedures (e.g., those in which noninsulated head frames are used), use extreme caution to maximize patient safety:

• Use the lowest power setting that achieves the desired effect.

• Place the patient return electrode as close to the surgical site as possible.

• Place dry gauze between the patient and the grounded object if possible.

• Continually monitor the contact point(s).

Patient and Operating Room

Safety

Force EZ Electrosurgical Generator C User’s Guide 3-9

During Surgery

Active Accessories

Warning

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 patients, the surgical team, and flammable materials

Simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at the electrode tip, burns to unintended tissues, or shocks and burns to the surgical team.

Some surgeons may elect to “buzz the hemostat” during surgical procedures. It is not recommended, and the hazards of such a practice probably cannot be eliminated. Burns to the surgeon’s hands are possible. To minimize the risk:

• Do not lean on the patient, the table, or the retractors while buzzing the hemostat.

• Activate cut rather than coag. Cut has a lower voltage than coag.

• Use the lowest power setting possible for the minimum time necessary to achieve hemostasis.

• Activate the generator after the accessory makes contact with the hemostat. Do not arc to the hemostat.

• Firmly grasp as much of the hemostat as possible before activating the generator. This disperses the current over a larger area and minimizes the current concentration at the finger tips.

• “Buzz the hemostat” below hand level (as close as possible to the patient) to reduce the opportunity for current to follow alternate paths through the surgeon’s hands.

• When using a stainless steel blade electrode, place the flat surface against the hemostat or other metal instrument.

• When using a coated or nonstick blade electrode, place the edge of the electrode against the hemostat or other metal instrument.

When not using active accessories, place them in a holster or in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns.

Patient Return Electrodes

Warning

To avoid patient burns, ensure that the patient return electrode firmly contacts the skin. Always check the patient return electrode periodically and after the patient is repositioned and during procedures involving long periods of activation.

3-10 Force EZ Electrosurgical Generator C User’s Guide

Laparoscopic Procedures

Warning

For laparoscopic procedures, be alert to these potential hazards:

• Laparoscopic surgery may result in gas embolism due to insufflation of gas in the abdomen.

• The electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated.

• Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient.

• Localized burns to the patient or physician may result from electrical currents carried through conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory (electrode or cable) being in close proximity to the conductive object.

• Do not use hybrid trocars that are composed of both metal and plastic components. For the operative channel, use all metal or all plastic systems. At no time should electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause unintended burns.

• When using laparoscopic instrumentation with metal cannulas, the potential exists for abdominal wall burns to occur due to direct electrode contact or capacitive coupling of RF current. This is most likely to occur in instances where the electrosurgical generator is activated for extended periods at high power levels inducing high current levels in the cannula.

• Ensure that the insulation of disposable and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal-to-metal sparking and neuromuscular stimulation and/or inadvertent sparking to adjacent tissue.

• Do not activate electrodes while in contact with other instruments as unintended tissue injury may occur.

• Do not activate the generator in an open circuit condition. To reduce the chances of unintended burns, activate the generator only when the active electrode is near or touching the target tissue.

• Use the lowest power setting that achieves the desired surgical effect and use a low voltage waveform (pure cut or desiccate) to lessen the potential for the creation of capacitive currents.

• Carefully insert and withdraw active electrodes from cannulas to avoid possible injury to the patient or damage to the devices.

During Surgery

Patient and Operating Room

Safety

Force EZ Electrosurgical Generator C User’s Guide 3-11

After Surgery

Warning

Electric Shock Hazard Always turn off and unplug the generator before cleaning.

Caution

Do not reuse or resterilize accessories labeled “disposable” or “single use only.”

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.

3-12 Force EZ Electrosurgical Generator C User’s Guide

Chapter 4

Before Surgery

This chapter contains the following procedures:

• Preparing the generator for surgery

• Preparing for bipolar surgery

• Preparing for monopolar surgery

• Setting up the special features

Caution

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

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

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

Quick Setup Instructions

If you are familiar with the Force EZ-C generator, you may prefer to follow this abbreviated procedure.

However, if you are not familiar with how the generator should be set up, refer to Setting Up the Generator on page 4-3 for detailed instructions.

1. Plug the generator power cord into the rear panel receptacle.

2. Plug the generator power cord into a grounded wall receptacle.

3. Turn on the generator and verify that the self-test is successfully completed.

4. Prepare for bipolar or monopolar electrosurgery:

Bipolar surgery:

• If using a footswitch, connect it to the appropriate footswitch receptacle on the front or rear panel.

• Connect the instrument to the appropriate instrument receptacle on the front panel.

• Verify or change and power settings.

(Optional – to display and use the previous setting, press the Pure and BLEND buttons simultaneously.)

Monopolar surgery:

• If using a footswitch, connect it to the appropriate footswitch receptacle on the front or rear panel. Use only a Valleylab monopolar footswitch with the Force EZ-C generator.

• Connect the instrument to the appropriate instrument receptacle on the front panel.

• Apply the patient return electrode to the patient and connect it to the Patient Return Electrode receptacle on the front panel.

• Press and hold the Low button to verify the selected low coag setting. The selected setting flashes in the Coag display.

(To change the low coag setting, refer to Setting Up the Special Features on page 4-

13.)

• Press and hold the High button to verify the selected high coag setting. The selected setting flashes in the Coag display.

(To change the high coag setting, refer to Setting Up the Special Features on page 4-

13.)

• Verify or change the mode and power settings.

(Optional – to display and use the previous setting, press the Pure and BLEND buttons simultaneously.)

4-2 Force EZ Electrosurgical Generator C User’s Guide

Setting Up the Generator

Warning

Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle.

Do not use power plug adapters.

Fire Hazard Do not use extension cords.

Patient Safety Use the generator only if the self-test has been completed as described.

Otherwise, inaccurate power outputs may result.

Caution

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.

Nonfunction of the generator may cause interruption of surgery. A backup generator should be available for use.

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 outlet having the correct voltage. Otherwise product damage may result.

1. Verify the generator is off by pressing the power switch off (O).

2. Place the generator on a stable flat surface, such as a table, platform, or Covidien cart. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes.

Before Surgery

Provide at least 4 to 6" (10 to 15 cm) of space from the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when the generator is used continuously for extended periods of time.

3. Plug the generator power cord into the rear panel receptacle.

4. Plug the generator power cord into a grounded receptacle.

Force EZ Electrosurgical Generator C User’s Guide 4-3

Setting Up the Generator

5. Turn on the generator by pressing the power switch on ( | ). Verify the following:

– All visual indicators and displays on the front panel illuminate.

– Activation tones sound to verify that the speaker is working properly.

Important

Status for the most recently used mode and power settings feature momentarily appears in the Cut display. The selected low (desiccate) setting and high (fulgurate) setting momentarily appear in the Coag display.

6. If the self-test is successful, a tone sounds. Verify the following:

– Either the Pure button indicator or the BLEND button indicator illuminates green,

– The right arrow indicator at the Footswitch Selector button illuminates green.

and either the LOW button indicator or the HIGH button indicator illuminates green.

– Each display shows a power setting of 1 watt.

– The REM Alarm indicator illuminates red.

If the self-test is not successful, an alarm tone sounds. A number may momentarily appear in the Cut display and, in most cases, the generator is disabled. Note the number and refer to Responding to System Alarms on page 7-12.

Once the self-test is successful, connect the accessories and set the generator controls. Refer to Preparing for Bipolar Surgery on page 4-5 or Preparing for Monopolar Surgery on page 4-8.

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

Preparing for Bipolar Surgery

If you plan to use a footswitching bipolar instrument, you must connect a footswitch. You may also use a footswitch to activate a handswitching instrument.

Connections for Bipolar Surgery

Warning

Electric Shock Hazard

• Do not connect wet accessories to the generator.

• Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

Do not apply a patient return electrode if only bipolar accessories are being used. Otherwise, the electrosurgical effect may not be limited to the tissue between the bipolar electrodes.

Caution

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

Connect accessories to the proper receptacle type. In particular, you must connect bipolar accessories to the Bipolar Instrument receptacle only. Improper connection of accessories may result in inadvertent generator activation or a REM Contact Quality Monitor alarm.

Bipolar connections (footswitch activation from the Bipolar Footswitch receptacle on the rear panel)

Footswitching or handswitching instrument

Bipolar footswitch

Before Surgery

Force EZ Electrosurgical Generator C User’s Guide 4-5

Preparing for Bipolar Surgery

Bipolar connections (footswitch activation from the Footswitch receptacle on the front panel)

Handswitching or footswitching instrument

Valleylab monopolar footswitch

Press the Footswitch Selector button until the left arrow indicator illuminates green.

Bipolar connection (handswitching instrument)

Handswitching instrument

4-6 Force EZ Electrosurgical Generator C User’s Guide

Preparing for Bipolar Surgery

Setting the Bipolar Output

Caution

Set power levels to the lowest setting before testing an accessory.

1. To increase (+) the power, turn the Bipolar Power Control knob clockwise. To decrease (-) the power, turn the knob counterclockwise. The maximum power setting for bipolar output is 70 watts.

2. To display and use the previous power setting, press the Pure and BLEND buttons simultaneously.

Force EZ Electrosurgical Generator C User’s Guide 4-7

Before Surgery

Preparing for Monopolar Surgery

If you plan to use a footswitching monopolar instrument, you must connect a Valleylab monopolar footswitch. You may also use a footswitch to activate a handswitching instrument.

For most procedures, you will connect only one monopolar instrument (handswitching or footswitching).

Connections for Monopolar Surgery

Warning

Electric Shock Hazard

• Do not connect wet accessories to the generator.

• Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

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

Caution

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

4-8 Force EZ Electrosurgical Generator C User’s Guide

Monopolar connections (handswitching instrument)

Handswitching instrument

Preparing for Monopolar Surgery

Patient return electrode

Monopolar connections (footswitch activation from the Monopolar Footswitch receptacle on the rear panel)

Handswitching or footswitching instrument

Patient return electrode

Valleylab monopolar footswitch

Before Surgery

Force EZ Electrosurgical Generator C User’s Guide 4-9

Preparing for Monopolar Surgery

Monopolar connections (footswitch activation from the Footswitch receptacle on the front panel)

Monopolar instrument

Footswitching instrument

Patient return electrode

Press the Footswitch Selector button until the right arrow indicator illuminates green.

Applying a Patient Return Electrode to the Patient

Warning

Do not cut a patient return electrode to reduce its size. Patient burns due to high current density may result.

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

Covidien recommends using REM Polyhesive patient return electrodes to maximize patient safety. Using a patient return electrode without the REM safety feature may result in a patient burn.

Refer to the manufacturer’s instructions for application site and placement procedures. When using metal plate patient return electrodes, use a conductive gel specifically designed for electrosurgery.

4-10 Force EZ Electrosurgical Generator C User’s Guide

Preparing for Monopolar Surgery

Using Two Generators Simultaneously

Caution

Two generators (and two patient return electrodes) may be used simultaneously on the same patient, provided the generators are the same type (both are isolated or both are ground referenced).

However, the two generators are not synchronized. One return electrode frequently acquires a high positive voltage while the other acquires an opposite negative voltage. When this occurs, the potential voltage difference between them may cause the current to flow from one patient return electrode to the other. The current causes no harm if it produces no sparks or high current densities on the patient.

Place each patient return electrode as close as possible to the site of the surgery to be performed by the generator to which it is connected. Ensure that the two patient return electrodes do not touch.

Pacemakers

Warning

To avoid interference with pacemakers, place the patient return electrode as close as possible to the site of surgery. Make sure the path the current follows from the site of surgery to the return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted.

Before Surgery

Force EZ Electrosurgical Generator C User’s Guide 4-11

Preparing for Monopolar Surgery

Selecting Cut and Coag Modes

Caution

Set power levels to the lowest setting before testing an accessory.

To display and use the previous power settings, press the Pure and Blend buttons simultaneously.

1. To select a cut mode, press the Pure or Blend button. The corresponding indicator illuminates green.

2. To select a coag mode, press the LOW (desiccate) or HIGH (fulgurate) button. The indicator in the button of the selected mode illuminates green.

To verify the selected low or high coag setting, press and hold the LOW or HIGH button. While you press the LOW button, a 1 (low 1), 2 (low 2), or 3 (low 3) appears in the Coag display. While you press the HIGH button, a 1 (high 1) or 2 (high 2) appears in the Coag display. For a description of the low and high coag settings, refer to Special Features on page 1-5. To change these settings, refer to Setting Up the Special Features on page 4-13.

Setting the Cut and Coag Output

1. To increase (+) the power, turn the Cut or Coag Power Control knob clockwise.

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

The generator allows the following maximum power settings:

Mode Power

Pure cut 300 watts

Blend cut 200 watts

Low (desiccate) coag and high (fulgurate) coag 120 watts

4-12 Force EZ Electrosurgical Generator C User’s Guide

Setting Up the Special Features

Five special features are available to customize the Force EZ-C generator. For an explanation of each feature, refer to Special Features on page 1-5. Refer to the following table for setup information. You must enter the setup mode to modify the special features.

Entering the Setup Mode

Important

During the setup mode, dashes (---) appear in the Bipolar display and the Bipolar Power Control knob has no function.

Press the Footswitch Selector button, the LOW button, and the High button simultaneously.

A number (1, 2, or 3) appears in the Coag display, and the indicator in the LOW or High button flashes.

Special Feature

Low (desiccate) coag settings

High (fulgurate) coag settings

Recall of most recently used modes and power settings

Action Cut

Display

1. Press the LOW button.

2. Turn the Coag Power Control knob to select the desired setting:

1 = low 1 (default) 2 = low 2 3 = low 3

1. Press the HIGH button.

2. Turn the Coag Power Control knob to select the desired setting:

1 = high 1 2 = high 2 (default)

1. Press the PURE button.

2. Turn the Cut Power Control knob to turn on or turn off this feature:

– – – blank 1, 2, or 3 LOW

– – – blank 1 or 2 HIGH

0 or 1 PURE

0 = off

1 = on (default)

Cut Button Indicator

flashes

Coag Display

– – – blank

Coag Button Indicator

flashes

Before Surgery

Force EZ Electrosurgical Generator C User’s Guide 4-13

Setting Up the Special Features

Cut Special Feature

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. When you exit the setup mode, the generator saves the coag mode selected at that time as the default coag mode.

Original default settings

Action Cut

Display

Press the LOW button.

Press the HIGH button. (default)

Press the PURE and BLEND buttons simultaneously.

A tone sounds.

– – –

The generator resets all modes, power settings, and special features to the original factory defaults.

Button

Indicator

blank

Coag Display

1, 2, or 3

1 or 2

Coag Button Indicator

LOW

flashes

HIGH flashes

Exiting the Setup Mode

To exit and save changes, press the Footswitch Selector button. If you changed the low or high coag settings during the setup mode, these new settings will be in effect. Otherwise, the generator returns to the modes and power settings (bipolar, cut, and coag) selected before entering the setup mode.

To exit and not save changes, press the power switch off (O).

4-14 Force EZ Electrosurgical Generator C User’s Guide

Chapter 5

During Surgery

This chapter covers the following topics:

• Checking accessory connections

• Checking the patient return electrode

• Changing the mode

• Selecting the power setting

• Activating the surgical instrument

• Adjusting the volume of activation tones

• Responding to alarms

• Calling the Covidien Clinical Information Hotline

Caution

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

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

Force EZ Electrosurgical Generator C User’s Guide 5-1

Checking Accessory Connections

Warning

Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.

Caution

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

Verify that all accessories are properly connected to the generator. When multiple accessories are used, keep cords separate. To reduce cross coupling, do not twist, bundle, or clamp cords together.

Checking the Patient Return Electrode

Warning

If a higher than expected power setting seems to be required or if the patient is repositioned, check the patient return electrode for secure placement and check all connecting cables for continuity.

Changing the Mode

Verify the selected cut and coag modes with the surgeon. You cannot change the mode while the generator is activated.

To change the mode, press the desired cut or coag mode button. The indicator in the button of the selected mode illuminates green. You can activate only one mode at a time.

To verify the selected low (desiccate) or high (fulgurate) coag setting, press and hold the Low or High button. While you press the Low button, a 1 (low 1), 2 (low 2), or 3 (low 3) appears in the Coag display. While you press the High button, a 1 (high 1) or 2 (high 2) appears in the Coag display. For a description of the low and high coag settings, refer to

Special Features on page 1-5. To change these settings, refer to Setting Up the Special Features on page 4-13.

When you change the cut or coag mode, the power setting remains the same unless it exceeds the maximum for the new mode. In that case, it reverts to the maximum for the new mode. For example, if you set the power to 250 watts for Pure cut, when you select Blend, the power setting changes to 200 watts, the maximum for Blend. If, however, you set the power to 65 watts in the low (desiccate) coag mode, when you select high (fulgurate), the power setting does not change because it falls within that mode’s range.

5-2 Force EZ Electrosurgical Generator C User’s Guide

Selecting the Power Setting

Warning

Confirm proper power settings before proceeding with surgery. Use the lowest power setting possible for the minimum time necessary to achieve the desired effect.

During a surgical procedure, the amount of current delivered during a given time period determines the amount of heating that occurs under the electrode. All Covidien patient return electrodes are designed for use during traditional surgical procedures and duty cycles (on time compared to off time). Users should consult Chapter 9, Technical Specifications for the recommended maximum duty cycle specifications.

It is not possible to foresee what combination of current and duty cycle may be safely used in every situation, such as when higher currents and/or longer duty cycles are used on procedures such as tissue lesioning, tissue ablation, tissue vaporization, and procedures where conductive fluid is introduced into the surgical site. Under these conditions there can be greater risk that the heating under a fully applied return electrode may be high enough to injure the patient.

During Surgery

When using a Covidien generator or patient return electrode during these types of surgical procedures the user should seek written guidance from the manufacturer of the active accessory regarding the currents and duty cycles that can be expected as well as detailed user instructions. In some instances, the application of additional patient return electrodes may help mitigate the increased risk.

Changing the Power Setting

Verify the power settings for the selected modes with the surgeon. You can change the power setting when the generator is on, including when it is activated.

To increase (+) the power, turn the Bipolar, Cut, or Coag Power Control knob clockwise.

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

As you turn the knob, the power changes by one setting (1, 5, or 10 watts), based on the settings available for the selected mode. Chapter 9, Technical Specifications, lists the available power settings.

When you change the power setting while the generator is activated, the power changes by one setting per second to prevent rapid increases or decreases in power to the surgical site. If you try to set the power above the maximum setting or below the minimum setting, a tone sounds.

Force EZ Electrosurgical Generator C User’s Guide 5-3

Selecting the Power Setting

Techniques for Keeping Power Settings Low

The power setting required to produce the desired surgical effect varies depending on the surgeon’s technique, the selected mode, and the size of the active electrode. Low power settings reduce the amount of current delivered to the patient, minimize the demand on the patient return electrode, and help protect the patient and surgical team from accidental burns and shocks.

The following are techniques for keeping power settings low.

Concentrating the current by using a small active electrode.

The smaller the active electrode, the higher the current density it delivers to tissue, and the less power it requires to produce the same surgical effect. For example, a needle electrode cuts at a lower power setting than a blade electrode. A small ball electrode desiccates or fulgurates tissue at a lower power setting than a large ball electrode.

Coagulating tissue by using fulguration rather than desiccation.

Because fulguration sparks to a wider area of tissue, surface coagulation can be achieved with a lower power setting using high (fulgurate) rather than low (desiccate).

Cutting by sparking rather than by desiccating tissue.

Cut produces continuous sparks that cut cleanly and quickly when the active electrode is held just above the tissue and kept in motion. Placing the active electrode in contact with the tissue produces desiccation that increases tissue resistance. A higher power setting may be required to overcome the increased resistance.

Using bipolar surgery.

Bipolar surgery requires lower power because the amount of tissue included in the electrosurgical circuit is limited to the tissue that is grasped by the bipolar instrument.

Typical Power Settings

Use the following list of typical power settings for various surgical procedures as a general guideline.

Caution

5-4 Force EZ Electrosurgical Generator C User’s Guide

Power Surgical Procedure

Activating the Surgical Instrument

During Surgery

Low Power

< 30 watts

Medium Power

Cut: 30–60 watts Coag: 30–70 watts

High Power

Cut: > 60 watts Coag: > 70 watts

Dermatology

Laparoscopic sterilization (both bipolar and monopolar)

Neurosurgery (both bipolar and monopolar)

Oral surgery

Plastic surgery

Polypectomy

Vasectomy

General surgery

Head and neck surgery (ENT)

Laparotomy

Orthopedic surgery (major)

Thoracic surgery (routine)

Vascular surgery (major)

Ablative cancer surgery, mastectomies, etc. (cut 60–120 watts; coag 70–120 watts)

Thoracotomy (heavy fulguration 70–120 watts)

Transurethral resections (cut 100–170 watts; coag 70–120 watts, depending on the thickness of the resection loop and the technique)

Activating the Surgical Instrument

Notice

Do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

To activate a handswitching instrument, use the controls on the instrument or on the appropriate footswitch. To activate a footswitching instrument, you must use a footswitch.

To reduce the possibility of alternate site burns that may be caused by RF leakage currents, avoid unnecessary and prolonged activation of the generator.

If a bipolar output is used when a return electrode is applied to the patient, the return electrode circuit is automatically deactivated to eliminate the possibility of current dispersal.

Force EZ Electrosurgical Generator C User’s Guide 5-5

Activation Indicators

Handswitching Footswitching Activation Indicator

Bipolar Close forceps tines

firmly

Monopolar Press CUT or COAG

button

Close forceps tines firmly

Bipolar footswitch connected to rear panel – press pedal

Monopolar footswitch connected to front panel – verify that the left arrow at the Footswitch Selector button illuminates and press either pedal

Monopolar footswitch connected to front panel – verify that the right arrow at the Footswitch Selector button illuminates and press the cut or coag pedal

Monopolar footswitch connected to rear panel – press the cut or coag pedal

Activation tone sounds – Bipolar indicator illuminates blue

Activation tone sounds – Cut indicator illuminates yellow or Coag indicator illuminates blue

Adjusting the Volume of Activation Tones

Caution

Do not decrease the activation tone to an inaudible level. The activation tone alerts the surgical team when an accessory is active

To change the volume of activation tones, turn the Volume knob on the rear panel:

• Clockwise, to increase the volume

• Counterclockwise, to decrease the volume.

You cannot silence the activation tones or adjust the alarm tone volume.

5-6 Force EZ Electrosurgical Generator C User’s Guide

Responding to Alarms

REM Alarm

A tone sounds twice, and the REM Alarm indicator flashes red. The indicator remains red and RF output is disabled until the alarm condition is corrected. When you correct a REM alarm condition, output is enabled and the REM Alarm indicator illuminates green.

Important

After successful completion of the self-test, the REM Alarm indicator flashes red and a tone sounds twice. No corrective action is required.

Alarm Situations

The following conditions can generate a REM alarm:

During Surgery

• The patient return electrode is not connected to the generator when the generator is activated for monopolar surgery.

• The return electrode does not have adequate contact with the patient.

• The contact area is reduced due to movement, loss of adhesion, fluid pooling, or dry contact gel.

• The return electrode cord is damaged, causing excessive resistance.

To correct an alarm condition, refer to Correcting a REM Alarm Condition on page 7-2.

Non-REM Patient Return Electrode Alarm

When a non-REM patient return electrode is connected and the generator detects a cord fault condition, the REM Alarm indicator illuminates red. When you correct the alarm condition, the indicator is extinguished.

System Alarm

When the generator senses a system alarm condition, an alarm tone sounds and the generator is deactivated. An alarm number flashes in the Cut display on the front panel.

1. Turn off the generator.

2. Turn on the generator and verify that the self-test is completed successfully. If the alarm number reappears, note the number and refer to Responding to System Alarms on page 7-12.

If you are unable to correct the system alarm condition, use a backup generator to complete the surgical procedure.

Force EZ Electrosurgical Generator C User’s Guide 5-7

Calling the Covidien Clinical Information Hotline

n the event of a clinical emergency, you can call the Covidien Clinical Information Hotline for assistance. A staff of knowledgeable RN, CNOR certified personnel are available to answer emergency questions 24 hours a day, seven days a week.

Call the toll free Hotline number (USA and Canada) at 1-800-255-8522 and enter *2005.

If calling after regular business hours (7 am to 5 pm Mountain Time, Monday through Friday, excluding holidays), follow the message prompts or hold for an operator.

5-8 Force EZ Electrosurgical Generator C User’s Guide

Chapter 6

After Surgery

This chapter includes the following instructions:

• Preparing the generator for reuse

• Storing the generator

Force EZ Electrosurgical Generator C User’s Guide 6-1

Preparing the Generator for Reuse

Caution

Do not reuse or resterilize accessories labeled “disposable” or “single use only.”

Step 1 – Disconnect the Accessories

A. Turn off the generator.

B. If applicable, remove the patient return electrode from the patient. Disconnect all

accessories from the front panel.

– If the accessory is disposable (single use only), dispose of it according to the

procedures for your institution.

– If the accessory is reusable, clean and sterilize it according to the manufacturer’s

instructions.

C. Disconnect and store any footswitch(es) used.

Step 2 – Clean the Generator

Warning

Electric Shock Hazard Always turn off and unplug the generator before 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.

A. Turn off the generator, and unplug the power cord from the wall outlet.

B. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning

solution or disinfectant and a damp cloth.

Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis.

The generator cannot be sterilized.

Storing the Generator

If the generator is stored at a temperature outside its normal operating range of 50° to 104° F (10° to 40° C), allow it to sit at room temperature for one hour prior to use.

The generator can be stored indefinitely. However, if you store it longer than one year, you must perform specific checkout procedures before use (refer to the service manual).

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

Chapter 7

Troubleshooting

This chapter includes the following procedures:

• Correcting a REM alarm condition

• Correcting malfunctions

• Responding to system alarms

Force EZ Electrosurgical Generator C User’s Guide 7-1

General Troubleshooting Guidelines

If the Force EZ-C generator malfunctions, check for obvious conditions that may have caused the problem:

• Check the generator for visible signs of physical damage.

• Make sure the fuse drawer is tightly closed.

• Verify that all cords are connected and attached properly.

• If an error code is displayed, turn off and then turn on the generator.

If the malfunction persists, the generator may require service. Contact your institution’s Biomedical Engineering Department.

Correcting a REM Alarm Condition

Sometimes the condition causing a REM alarm is readily apparent; for example, the plug is not fully inserted into the generator receptacle. At other times, the condition causing the REM alarm is more difficult to determine. This procedure for determining the alarm condition starts with the obvious, then presents more detail.

Checking for Obvious Problems

To begin determining the condition causing a REM alarm, follow these steps:

1. Verify that the patient return electrode cord is correctly connected to the generator.

2. Inspect the plug, cord, and the connection of the cord to the return electrode. If you find evidence of excessive wear, cracks, breaks, or other visible damage, replace the return electrode and/or the cord.

3. Verify that the return electrode is in contact with the patient, per the package instructions for applying the return electrode.

4. If the REM alarm persists:

If you are using a REM Polyhesive patient return electrode, perform a detailed inspection. Refer to Performing a Detailed Inspection on page 7-3.

If you are using a patient return electrode without the REM safety feature, apply a new patient return electrode and/or use a backup generator to complete the surgical procedure.

7-2 Force EZ Electrosurgical Generator C User’s Guide

Correcting a REM Alarm Condition

Performing a Detailed Inspection

If your first check found no obvious condition causing a REM alarm, perform a more detailed inspection. Follow these steps:

1. Inspect the return electrode connector.

a. Unplug the patient return electrode from the generator.

b. Verify that the pin on the plug is present and not bent.

Carefully reinsert the plug into the Patient Return Electrode receptacle.

Ensure that the pin enters the hole and that the plug inserts fully.

If the alarm persists, go to the next step.

2. Apply firm pressure over the entire surface area of the patient return electrode, particularly the center.

3. If the REM alarm persists, apply another REM Polyhesive patient return electrode.

Applying Additional REM Polyhesive Patient Return Electrodes

If your inspections have been unable to determine the condition causing the REM alarm, apply another REM Polyhesive patient return electrode. Follow this procedure:

1. Apply a second patient return electrode.

a. Unplug the patient return electrode from the generator. Do not remove it from the

patient.

b. Apply a second REM electrode to an appropriate site and connect it to the Patient

Return Electrode receptacle on the generator.

Applying a second REM electrode

Second REM electrode

Troubleshooting

If the alarm clears, leave the generator on during draping to avoid disturbing the return electrode. Remove the return electrode that is not in use.

If the alarm persists, go to the next step.

Force EZ Electrosurgical Generator C User’s Guide 7-3

Correcting a REM Alarm Condition

2. Apply a third patient return electrode.

a. Unplug the second patient return electrode from the generator. Do not remove

either the first or the second return electrode from the patient.

b. Apply a third REM Polyhesive patient return electrode to the patient and connect it

to the Patient Return Electrode receptacle. Select the next best, well vascularized, convex area close to the surgical site.

Applying a third REM electrode

Third REM Electrode

If the alarm clears, leave the generator on during draping to avoid disturbing the return electrode. Remove the return electrodes that are not in use.

If the alarm persists, go to the next step.

3. Unplug the patient return electrode from the generator.

Use a Covidien multiple return/S cord adapter (E0507B) to connect two patient return electrodes to the generator.

a. Insert the adapter into the Patient Return Electrode receptacle.

Attaching two REM electrodes to the generator simultaneously

Adapter

b. Insert the plugs of two of the patient return electrodes into the adapter. Choose

the two return electrodes that are on the most vascularized, convex areas in closest proximity to the surgical site.

7-4 Force EZ Electrosurgical Generator C User’s Guide

Correcting a REM Alarm Condition

If the alarm clears, leave the generator on during draping to avoid disturbing the return electrodes. Remove the return electrode that is not in use.

If the REM alarm persists, use a backup generator and repeat these steps.

When you correct a REM alarm condition, the generator enables itself and the REM Alarm indicator changes as described below:

• If you are using a REM Polyhesive patient return electrode, the indicator illuminates green.

• If you are using a patient return electrode without the REM safety feature, the generator extinguishes the red indicator light.

Troubleshooting

Force EZ Electrosurgical Generator C User’s Guide 7-5

Correcting Malfunctions

If a solution is not readily apparent, use the table below to help identify and correct specific malfunctions. After you correct the malfunction, verify that the generator completes the self-test as described in Setting Up the Generator on page 4-3.

Situation Possible Cause Solution

Abnormal neuromuscular stimulation (stop surgery

immediately)

Generator does not respond when turned on

Metal-to-metal sparking Check all connections to the

generator, patient return electrode, and active electrodes.

Can occur during coag (more likely when fulgurating than when cutting, and unlikely when desiccating)

Abnormal 50–60 Hz leakage currents

Disconnected power cord or faulty wall outlet

Faulty power cord Replace the power cord.

Fuse drawer is open or fuses are blown

Use a lower power setting for the high (fulgurate) mode or select the low (desiccate) mode.

Refer to your Biomedical Engineering Department or contact a Covidien Representative for assistance.

Check power cord connections (generator and wall outlet). Connect the power cord to a functional outlet.

Close the fuse drawer. Replace the blown fuse(s). Refer to the

Force EZ Electrosurgical Generator C/8C Service Manual.

Internal component malfunction

Use a backup generator. Refer to your Biomedical Engineering Department or contact a Covidien Representative for assistance.

7-6 Force EZ Electrosurgical Generator C User’s Guide

Situation Possible Cause Solution

Correcting Malfunctions

Generator is on, but did not complete the self-test

Software malfunction Turn off, then turn on the

generator.

Internal component malfunction

Use a backup generator. Refer to your Biomedical Engineering Department or contact a Covidien Representative for assistance.

Troubleshooting

Force EZ Electrosurgical Generator C User’s Guide 7-7

Correcting Malfunctions

Situation Possible Cause Solution

Generator is on and accessory is activated, but generator does not deliver output

Malfunctioning footswitch or handswitching instrument

Incompatible footswitch Use only a Valleylab monopolar

Footswitch is connected to front panel Footswitch receptacle, but arrow indicator at Footswitch Selector button does not indicate desired instrument receptacle

Turn off the generator. Check and correct all accessory connections.

Turn on the generator. Replace the accessory if it continues to malfunction.

footswitch with the Force EZ-C generator.

1. Verify all accessory connections.

2. Press the Footswitch Selector button to illuminate the arrow indicator for the desired instrument receptacle: the left arrow indicator illuminates for the Bipolar Instrument receptacle; the right arrow indicator illuminates for the Monopolar Footswitching Accessory receptacle.

Footswitch connected to front panel Footswitch receptacle is being used for surgical instrument connected to Monopolar Footswitching or Handswitching Instrument receptacle

Footswitch connected to rear panel Monopolar Footswitch receptacle is being used for instrument connected to Monopolar Footswitching Accessory receptacle

Continued on next page

• Connect the footswitch to

the rear panel Monopolar Footswitch receptacle.

• If you are using a

footswitching instrument, connect it to the Accessory receptacle.

• Connect the footswitch to

the front panel Footswitch receptacle

• Connect the instrument to

the Monopolar Footswitching or Handswitching Instrument receptacle.

7-8 Force EZ Electrosurgical Generator C User’s Guide

Situation Possible Cause Solution

Correcting Malfunctions

Generator is on and accessory is activated, but generator does not deliver output

Continued

Continuous monitor interference

Power is set too low Increase the power setting.

Refer to Changing the Power Setting on page 5-3

An alarm condition exists 1. Check the Cut display for

an alarm number. Note the number and refer to

Responding to System Alarms on page 7-12.

2. In case of a REM alarm, refer to Correcting a REM Alarm Condition on page 7-2

Faulty chassis-to-ground connections

Electrical equipment is grounded to different objects rather than a common ground. The generator may respond to the resulting voltage differences between grounded objects.

1. Check and correct the chassis ground connections for the monitor and for the generator.

2. Check other electrical equipment in the room for defective grounds.

Plug all electrical equipment into line power at the same location. Contact your Biomedical Engineering Department or a Covidien Representative for assistance.

Troubleshooting

Malfunctioning monitor Replace the monitor.

Force EZ Electrosurgical Generator C User’s Guide 7-9

Correcting Malfunctions

Situation Possible Cause Solution

Interference with other devices only when the generator is activated

Metal-to-metal sparking Check all connections to the

generator, patient return electrode, and accessories.

High settings used for fulguration

Electrically inconsistent ground wires in the operating room

If interference continues when the generator is activated, the monitor is responding to radiated frequencies.

Use lower power settings for high (fulguration) mode or select the low (desiccate) mode.

Verify that all ground wires are as short as possible and go to the same grounded metal.

Ask your Biomedical Engineering Department to check with the manufacturer of the monitor.

Some manufacturers offer RF choke filters for use in monitor leads. The filters reduce interference when the generator is activated and minimize the potential for an electrosurgical burn at the site of the monitor electrode.

7-10 Force EZ Electrosurgical Generator C User’s Guide

Situation Possible Cause Solution

Correcting Malfunctions

Pacemaker interference Intermittent connections or

metal-to-metal sparking

Current traveling from active to return electrode during monopolar electrosurgery is passing too close to pacemaker.

Check the active and patient return electrode cord connections.

It may be necessary to reprogram the pacemaker.

Use bipolar instruments, if possible.

If you must use a monopolar instrument, place the patient return electrode as close as possible to the surgical site. Make sure the current path from the surgical site to the patient return electrode does not pass through the vicinity of the heart or the site where the pacemaker is implanted.

Always monitor patients with pacemakers during surgery and keep a defibrillator available.

Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned in patients with cardiac pacemakers.

Troubleshooting

Internal Cardiac Defibrillator (ICD) activation

ICD is activated by electrosurgical generator.

Stop the procedure and contact the ICD manufacturer for instructions.

Force EZ Electrosurgical Generator C User’s Guide 7-11

Responding to System Alarms

When a system alarm condition exists, an alarm tone sounds and a number flashes in the Cut display. The generator is disabled until the condition is cleared.

Most system alarms require some action on your part to correct the condition; however, some are corrected automatically. Use the following table to determine how to correct an alarm condition.

After correcting the alarm condition, verify that the generator completes the self-test as described in Setting Up the Generator on page 4-3.

Number Description Recommended Action

0-7 Microcontroller malfunction Contact your Biomedical Engineering

Department.

10 Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

11-14

17-19 Internal component

30-32

40 50-51 54-55 57-66

67 Internal diagnostics Turn off, then turn on the generator. If the

68 Microcontroller malfunction Contact your Biomedical Engineering

69-71

Diagnostic/microcontroller malfunction

malfunction

Software malfunction Turn off, then turn on the generator. If the

Contact your Biomedical Engineering Department.

Do not attempt to use the generator. Record the number and call the Covidien Service Center.

alarm number reappears, record the number and call the Covidien Service Center.

Department.

alarm number reappears, record the number and call the Covidien Service Center.

81 Internal component

malfunction

Do not attempt to use the generator. Record the number and call the Covidien Service Center.

7-12 Force EZ Electrosurgical Generator C User’s Guide

Number Description Recommended Action

Responding to System Alarms

100-105 109-119

120 Calibration malfunction Contact your Biomedical Engineering

121 Software malfunction Turn off, then turn on the generator. If the

122 Calibration malfunction Contact your Biomedical Engineering

123-126 Microcontroller malfunction Contact your Biomedical Engineering

127-128 Internal component

129-140

150

Microcontroller malfunction Contact your Biomedical Engineering

Department.

Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

Department.

alarm number reappears, record the number and call the Covidien Service Center.

Department.

Do not attempt to use the generator. Record

malfunction

Software malfunction Turn off, then turn on the generator. If the

the number and call the Covidien Service Center.

alarm number reappears, record the number and call the Covidien Service Center.

Troubleshooting

151 Microcontroller malfunction Contact your Biomedical Engineering

Department.

152 Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

154 Microcontroller malfunction Contact your Biomedical Engineering

Department.

159 Internal diagnostics Contact your Biomedical Engineering

Department.

160 Internal component

malfunction

Contact your Biomedical Engineering Department.

Force EZ Electrosurgical Generator C User’s Guide 7-13

Responding to System Alarms

Number Description Recommended Action

161, 163 Dosage error Do not attempt to use the generator. Record

164-166 Dosage error Contact your Biomedical Engineering

170-173 Microcontroller malfunction Contact your Biomedical Engineering

174 Software malfunction Turn off, then turn on the generator. If the

180-185 Internal diagnostics Contact your Biomedical Engineering

the number and call the Covidien Service Center.

Department.

alarm number reappears, record the number and call the Covidien Service Center.

Department.

189 Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

191 Cut mode buttons (PURE and/

or BLEND) may be stuck

192 Coag mode buttons (LOW

and/or HIGH) may be stuck

193 Front panel Footswitch button

may be stuck

194 Handswitch or monopolar

footswitch cut pedal may be stuck

195 Handswitch or monopolar

footswitch coag pedal may be stuck

196 Handswitch or cut key may be

stuck

197 Handswitch or coag key may

be stuck

Turn off, then turn on the generator. Ensure that no buttons or accessory activation devices are pressed during the self-test.

If the alarm number reappears, disconnect all accessories. Then, turn off and turn on the generator again. If the alarm number reappears, record the number and call the Covidien Service Center.

198 Handswitch or bipolar

footswitch pedal may be stuck

7-14 Force EZ Electrosurgical Generator C User’s Guide

Responding to System Alarms

Number Description Recommended Action

199-203 Internal diagnostics Contact your Biomedical Engineering

Department.

206-207 Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

208-209 Microcontroller malfunction Contact your Biomedical Engineering

Department.

210-211 Software malfunction Turn off, then turn on the generator. If the

alarm number reappears, record the number and call the Covidien Service Center.

212-213 Internal diagnostics Contact your Biomedical Engineering

Department.

214 Internal component

malfunction

215-216 Internal diagnostics Contact your Biomedical Engineering

220-221 223-226

230-231 Software malfunction Turn off, then turn on the generator. If the

232 Microcontroller malfunction Contact your Biomedical Engineering

233 240-242 244-245

246-247 Microcontroller malfunction Contact your Biomedical Engineering

260 Internal diagnostics Contact your Biomedical Engineering

Diagnostics / microcontroller malfunction

Software malfunction Turn off, then turn on the generator. If the

Do not attempt to use the generator. Record the number and call the Covidien Service Center.

Department.

Contact your Biomedical Engineering Department.

alarm number reappears, record the number and call the Covidien Service Center.

Department.

alarm number reappears, record the number and call the Covidien Service Center.

Department.

Troubleshooting

Force EZ Electrosurgical Generator C User’s Guide 7-15

Number Description Recommended Action

261-262 270-271

451 The internal temperature limit

Software malfunction Turn off, then turn on the generator. If the

was exceeded due to length of activation time.

alarm number reappears, record the number and call the Covidien Service Center.

Verify that the location of the generator allows for adequate cooling.

Use the lowest power setting that achieves the desired effect. Limit activation times if possible.

Chapter 8

Maintenance and Repair

This chapter presents the following information:

• The manufacturer’s responsibility

• Routine maintenance

• Returning the generator for service

• Service centers

Force EZ Electrosurgical Generator C User’s Guide 8-1

Responsibility of the Manufacturer

Covidien is responsible for the safety, reliability, and performance of the generator only under the following circumstances:

• Installation and setup procedures in this manual are followed.

• Assembly operation, readjustments, modifications, or repairs are carried out by persons authorized by Covidien.

• The electrical installation of the relevant room complies with local codes and regulatory requirements.

• The equipment is used in accordance with the Covidien instructions for use.

For warranty information, refer to Limited Warranty in the Preface of this guide.

Routine Maintenance

Notice

Refer to the generator service manual for maintenance recommendations and function and output power verification procedures.

When should the generator be checked or serviced?

Covidien recommends that the generator be inspected by qualified service personnel at least once a year. This inspection should include checking the calibration of the generator.

When should the power cord be checked or replaced?

Check the power cord each time you use the generator or at the intervals recommended by your institution. Replace the power cord if you find exposed wires, cracks, frayed edges, or a damaged connector.

When should the fuses be replaced?

An internal component malfunction can damage the fuses. You may need to replace the fuses if the generator fails the self-test or if the generator stops functioning, even though it is receiving power from a wall outlet. Refer to the service manual for instructions.

8-2 Force EZ Electrosurgical Generator C User’s Guide

Returning the Generator for Service

Before you return the generator, call your Covidien representative for assistance. If you are instructed to send the generator to Covidien, first obtain a Return Authorization Number. Then, clean the generator and ship it to Covidien for service.

Step 1 – Obtain a Return Authorization Number

Call the Covidien Customer Service Center for your area to obtain a Return Authorization Number. Have the following information ready when you call:

• Hospital/clinic name/customer number

• Telephone number

• Department/address, city, state, and zip code

•Model number

• Serial number

• Description of the problem

• Type of repair to be done

Step 2 – Clean the Generator

Warning

Electric Shock Hazard Always turn off and unplug the generator before 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.

A. Turn off the generator, and unplug the power cord from the wall outlet.

B. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning

solution or disinfectant and a damp cloth.

Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis.

The generator cannot be sterilized.

Maintenance and Repair

Force EZ Electrosurgical Generator C User’s Guide 8-3

Service Center

Step 3 – Ship the Generator

A. Attach a tag to the generator that includes the Return Authorization Number and the

information (hospital, phone number, etc.) listed in Step 1 – Obtain a Return Authorization Number on page 8-3.

B. Be sure the generator is completely dry before you pack it for shipment. Package it in

its original shipping container, if available.

C. Ship the generator, prepaid, to the Covidien Service Center.

Service Center

For a complete list of service centers worldwide, please refer to the Covidien web site:

http://www.valleylab.com/valleylab/international/service-world.html

8-4 Force EZ Electrosurgical Generator C User’s Guide

Chapter 9

Technical Specifications

All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (77° F/25° C) and a nominal input power voltage.

Force EZ Electrosurgical Generator C User’s Guide 9-1

Performance Characteristics

General

Output configuration Isolated output

Cooling Natural convection; side and rear panel vents

Display Eight digital seven-segment displays: 0.75" (1.9 cm)

Mounting Universal Mounting cart (UC8009) or any stable flat

each

surface

Dimensions and Weight

Width 16" (40.6 cm)

Depth 15.6"(39.5 cm)

Height 5" (12.7 cm)

Weight <15 lb (< 6.8 kg)

Operating Parameters

Ambient temperature range

Relative humidity 30% to 75%, noncondensing

Atmospheric pressure 700 to 1060 millibars

Warm-up time If transported or stored at temperatures outside the

50° to 104° F (10° to 40° C)

operating temperature range, allow one hour for the generator to reach room temperature before use.

9-2 Force EZ Electrosurgical Generator C User’s Guide

Transport and Storage

Performance Characteristics

Technical Specifications

Ambient temperature range

Relative humidity 25% to 85%, noncondensing

Atmospheric pressure 500 to 1060 millibars

Duration of storage If stored longer than one year, the battery must be

-29° to 149° F (-34° to 65° C)

replaced and a full checkout, including calibration, must be completed before use. For instructions, refer to the Force EZ Electrosurgical Generator C/8C Service Manual.

Duty Cycle

Under maximum power settings and rated load conditions (Pure cut, 300 watt setting, 300 ohm load) the generator is suitable for activation times of 10 seconds on, 30 seconds off for one hour. With lesser settings and loads, you can activate the generator for greater durations without generating excessive internal temperatures.

If the internal temperature of the generator is too high, an alarm tone sounds and a number (451) flashes in the Cut display alternately with the power settings. You can activate the generator and change the power settings while this condition

Force EZ Electrosurgical Generator C User’s Guide 9-3

Performance Characteristics

Internal Memory

Memory type Nonvolatile, battery-backed RAM

Battery type 3 V lithium button cell

Battery life 5 years

Storage capacity • The last 20 error codes detected by the generator

• The number of times and length of activation for

each mode

• The average power setting used for each mode

• The total time the generator is on

• Calibration constants

• Special features settings

• Last setup parameters

• Other service-related information

Audio Volume

The audio levels stated below are for activation tones (bipolar, cut, and coag) and alarm tones (REM and system alarms) at a distance of one meter. Alarm tones meet the requirements for IEC 60601-2-2 and AAMI HF18.

Activation Tone

Volume (adjustable) 45 to

Frequency Bipolar: 554 Hz

Duration Continuous while the generator is activated

≥ 65 dBA

Cut: 440 Hz

Coag: 554 Hz

9-4 Force EZ Electrosurgical Generator C User’s Guide

Alarm Tone

Performance Characteristics

Technical Specifications

Vol u me (n ot adjustable)

Frequency 440 Hz

Duration 250 to 500 ms

≥ 65 dBA

REM Contact Quality Monitor

REM current is measured according to IEC 60601-1, Ed. 1988.

Measurement frequency

Measurement current < 10 μA

Acceptable Resistance Range

REM resistance measurements are ± 10% during RF activation and ± 5% when RF output is not activated.

REM Polyhesive patient return electrode: 5 to 135 ohms or up to a 40% increase in the baseline contact resistance (whichever is less).

80 kHz ± 10 kHz

Patient return electrode without the REM safety feature (single section electrode): 0 to 20 ohms.

If the measured resistance is outside the acceptable range(s) noted above, a REM fault condition occurs.

REM Alarm Activation

REM Polyhesive patient return electrode: When the measured resistance exceeds

the standard range of safe resistance (below 5 ohms or above 135 ohms) or when the baseline measured contact resistance increases by 40% (whichever is less), the REM Alarm indicator flashes red, a tone sounds twice, and RF output is disabled. The indicator remains illuminated red until you correct the condition causing the alarm. Then, the indicator illuminates green and RF output is enabled.

Patient return electrode without the REM safety feature: When the measured resistance between the patient return electrode pins exceeds 20 ohms, the REM Alarm indicator flashes red, a tone sounds twice, and RF output is disabled. The indicator remains illuminated red until you correct the condition causing the alarm. Then, the red indicator is extinguished and RF output is enabled.

Force EZ Electrosurgical Generator C User’s Guide 9-5

Performance Characteristics

Serial Port

RS-232 compatible; 9600 baud, 8 data bits, 1 stop bit, no parity.

9-pin connector supports the following signals

Pin 2 – isolated transmit (serial data output transmit line)

Pin 3 – isolated receive (serial data input receive line)

Pin 5 – isolated ground (reference for transmit and receive)

RF Activation Port

The RF activation port is a subminiature telephone jack attached to the contacts of a small relay. The contacts are closed when the output is energized and open at all other times. This port provides a means to tell other equipment that RF current is being generated. This may be useful when making EEG or ECG measurements.

Low Frequency (50–60 Hz) Leakage Current

Enclosure source current, ground open

Source current, patient leads, all outputs

< 100 μA

Normal polarity, intact ground: < 10 μA

Normal polarity, ground open: < 50 μA

Reverse polarity, ground open: < 50 μA

Sink current at high line, all inputs

< 20 μA

High Frequency (RF) Leakage Current

Bipolar RF leakage current

Monopolar RF leakage current

9-6 Force EZ Electrosurgical Generator C User’s Guide

< 60 mA

< 150 mA

rms

Input Power

100–120 Volt 220–240 Volt

Performance Characteristics

Technical Specifications

Maximum VA at nominal line voltage:

Idle: 50 VA

Bipolar: 500 VA

Cut: 850 VA

Coag: 500 VA

Input mains voltage, full regulation range: 90–135 Vac

Input mains voltage, operating range: 85–140 Vac

Mains current (maximum):

Idle: 0.4 A

Bipolar: 4.2 A

Cut: 8.0 A

Coag: 4.2 A

Mains line frequency range (nominal): 50 Hz to 60 Hz

Mains fuse: F8.0 A Mains fuse: T4.0 A

Maximum VA at nominal line voltage:

Idle: 50 VA

Bipolar: 500 VA

Cut: 850 VA

Coag: 500 VA

Input mains voltage, full regulation range: 186–264 Vac

Input mains voltage, operating range: 170–280 Vac

Mains current (maximum):

Idle: 0.2 A

Bipolar: 2.1 A

Cut: 4.0 A

Coag: 2.1 A

Mains line frequency range (nominal): 50 Hz to 60 Hz

Power cord: 3-prong hospital grade connector

Power cord: 3-prong locally approved connector

Force EZ Electrosurgical Generator C User’s Guide 9-7

Performance Characteristics

Power Cord Specification

This unit was equipped from the factory with either a 110VAC hospital grade NEMA 5-15 power cord or a 220VAC CEE7/7 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications:

100-120 VAC

Cable - SJT16/3, IEC color code, maximum length 15’ (5 m) Plug - minimum 10 A - 125 VAC Unit receptacle - IEC female, minimum 10 A - 125 VAC

220-240 VAC

Cable - H05VVF3G1.0 VDE, maximum length 15’ (5 m) Plug - minimum 6 A - 250VAC Unit receptacle - IEC female, minimum 6 A - 250VAC

9-8 Force EZ Electrosurgical Generator C User’s Guide

Standards and IEC Classifications

The Force EZ-C generator meets all pertinent clauses of the IEC 60601-1 second edition and IEC 60602-2-2 third edition.

ATTENTION

Consult accompanying documents.

Technical Specifications

The generator output is floating (isolated) with respect to ground.

DANGER

Explosion risk if used with flammable anesthetics.

Rear Panel—To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualified service personnel.

Front Panel—Dangerous Voltage Output.

Non-Ionizing Radiation

Classified with respect to electrical shock, fire, and mechanical hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1.

Class I Equipment (IEC 60601-1)

Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor.

Force EZ Electrosurgical Generator C User’s Guide 9-9

Standards and IEC Classifications

Type CF Equipment (IEC 60601-1)/Defibrillator Proof

Liquid Spillage (IEC 60601-2-2 Clause 44.3)

The Force EZ-C generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which, when wetted, are likely to adversely affect the safety of the equipment.

The Force EZ-C generator provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type CF isolated (floating) output and may be used for procedures involving the heart.

The Force EZ-C generator patient return electrode terminal is protected from defibrillator discharge according to ANSI/AAMI HF18 and IEC 60601-2-2.

Electromagnetic Interference

When placed on or beneath an activated Covidien electrosurgical generator, the Force EZ-C generator operates without interference. The generator minimizes electromagnetic interference to video equipment used in the operating room. The generator complies with the requirements of IEC 61000-4-2.

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

The Force EZ-C generator complies with the appropriate IEC 60601-1-2 and IEC 606012-2 specifications regarding electromagnetic compatibility.

Applied Parts E2515, E2516, E2003, E4053-CT, E7507, E7506, E6008B, and E6009 were tested with the unit and the combination was found to be in compliance with IEC 606012-2 (Third Edition). Safety of use of other accessories, not identified in these instructions, has not been determined by Underwriters Laboratories, Inc.

Notice

The Force EZ requires special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Force EZ Electrosurgical Generator C/8C Service Manual.

Portable and mobile RF communications equipment can affect the Force EZ. Refer to the EMC information provided in the Force EZ Electrosurgical Generator C/8C Service Manual.

9-10 Force EZ Electrosurgical Generator C User’s Guide

Output Characteristics

Voltage Transients (Emergency Generator Mains Transfer)

The Force EZ-C generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source.

Output Characteristics

Maximum Output for Force EZ-C Generator Modes

Power readouts agree with actual power into rated load to within 15% or 5 watts, whichever is greater.

Technical Specifications

Open Circuit P-P

Mode

Bipolar 300 V 100 Ω 70 W 1.5

Monopolar Cut

Pure

Blend

Monopolar Coag

Low 1

Low 2

Low 3

High 1

High 2

Voltage (max)

2000 V

3400 V

3500 V

660 V

1100 V

6000 V

8500 V

Rated Load (max) Power

(max)

300 Ω

500 Ω

300 Ω

500 Ω

300 W

200 W

120 W

Crest

Factor (typical @ Rated Load)

1.5

2.1

5.0

1.5

4.9

7.0

a. An indication of a waveform’s ability to coagulate bleeders without a cutting effect

Force EZ Electrosurgical Generator C User’s Guide 9-11

Output Characteristics

Available Power Settings in Watts

Bipolar

12345678910

11 12 13 14 15 16 17 18 19 20

21 22 23 24 25 26 27 28 29 30

31 32 33 34 35 36 37 38 39 40

45 50 55 60 65 70

Monopolar Cut: Pure

12345678910

11 12 13 14 15 16 17 18 19 20

21 22 23 24 25 26 27 28 29 30

31 32 33 34 35 36 37 38 39 40

45 50 55 60 65 70 75 80 85 90

95 100 110 120 130 140 150 160 170 180

190 200 210 220 230 240 250 260 270 280

290 300

9-12 Force EZ Electrosurgical Generator C User’s Guide

Monopolar Cut: Blend

12345678910

11 12 13 14 15 16 17 18 19 20

21 22 23 24 25 26 27 28 29 30

31 32 33 34 35 36 37 38 39 40

45 50 55 60 65 70 75 80 85 90

95 100 110 120 130 140 150 160 170 180

Output Characteristics

Technical Specifications

190 200

Monopolar Coag

12345678910

11 12 13 14 15 16 17 18 19 20

21 22 23 24 25 26 27 28 29 30

31 32 33 34 35 36 37 38 39 40

45 50 55 60 65 70 75 80 85 90

95 100 110 120

Force EZ Electrosurgical Generator C User’s Guide 9-13

Output Characteristics

Output Waveforms

Instant Response technology, an automatic adjustment, controls the bipolar mode, the cut modes, and the low 2 and low 3 coag settings. It does not control the low 1, high 1, and high 2 coag modes.

As tissue resistance increases from zero, the generator outputs constant current followed by constant power followed by constant voltage. The maximum output voltage is controlled to reduce capacitive coupling and video interference and to minimize sparking.

Bipolar

Monopolar Cut

Standard 470 kHz sinusoid

Pure 393 kHz sinusoid

Blend 393 kHz bursts of sinusoid recurring at 27.1 kHz

intervals, 50% duty cycle

Monopolar Coag

Desiccation

Low 1

Low 2

Low 3

Fulguration

High 1

High 2

240 ± 40 kHz sinusoid recurring at 39 kHz. 8% duty cycle at open load

393 kHz sinusoid

470 kHz damped sinusoidal bursts with a repetition frequency of 57 kHz at open load

470 kHz damped sinusoidal bursts with a repetition frequency of 30 kHz at open load

9-14 Force EZ Electrosurgical Generator C User’s Guide

Output Power vs. Resistance Graphs

The graphs that follow depict the changes for each mode at specific power settings.

Note: These curves represent the lower and upper limits of output power with tolerance included. The normal output power will be halfway between these two curves.

Bipolar Graph

The insulating surface described in IEC 60601-2-2 and full length leads was used to obtain the bipolar output measurements.

Standard Bipolar 35W mode — load resistance vs. output power

Technical Specifications

Output Power (watts)

Load Resistance (ohms)

Force EZ Electrosurgical Generator C User’s Guide 9-15

Output Power vs. Resistance Graphs

Standard Bipolar 70W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

Note: In the Bipolar Standard mode only, the power curve will reflect both High and Low output values between the impedance range of 800-1000 ohms. This is based on the sensed impedance value the generator calculates, and the tolerances of the sensing circuits. This is a function of the generator, as the software is designed to reduce (switch to Low output) the output power when the impedance exceeds a reference (800-1000 ohms impedance) level. Clinically, above 800 ohms the tissue is almost completely desiccated. By dropping to lower output power levels, we allow the surgeon sufficient time to deactivate the output before tissue sticking occurs.

9-16 Force EZ Electrosurgical Generator C User’s Guide

Output Power vs. Resistance Graphs

Monopolar Cut Graphs

Covidien used the procedures described in IEC 60601-2-2 and full length leads to obtain the monopolar cut output measurements.

Pure 150W mode — load resistance vs. output power

Output Power (watts)

Technical Specifications

Load Resistance (ohms)

Pure 300W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

Force EZ Electrosurgical Generator C User’s Guide 9-17

Output Power vs. Resistance Graphs

Blend 100W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

Blend 200W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

9-18 Force EZ Electrosurgical Generator C User’s Guide

Valleylab Force EZ User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual