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User’s Guide

TM

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 EZTM 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-tipTM RFA Generator One year from date of shipment

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

LigaSureTM Vessel Sealing System One year from date of shipment

LigaSureTM Reusable Instruments One year from date of shipment

Mounting Fixtures (all models) One year from date of shipment

Footswitches (all models) One year from date of shipment

ValleylabTM Argon Gas Delivery Unit II One year from date of shipment

RapidVacTM Smoke Evacuator One year from date of shipment

LigaSureTM Sterile Single Use Items Sterility only as stated on packaging

Cool-tipTM Sterile Single Use Items Sterility only as stated on packaging

Sterile Single Use Items Sterility only as stated on packaging

Patient Return Electrodes Shelf life only as stated on packaging

Notwithstanding any other provision herein or in any other document or communication,


Covidien’s liability with respect to this limited warranty and the products sold hereunder
shall be limited to the aggregate purchase price for the products sold to the customer.
This limited warranty is non-transferable and runs only to the original purchaser of the
covered product(s). There are no warranties which extend beyond the terms hereof.
Covidien disclaims any liability hereunder or elsewhere in connection with the sale of
products and for any form of indirect, tort, or consequential damages.

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

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 ResponseTM technology
• Standard bipolar mode
• Two monopolar cut modes: pure and blend
• Two monopolar coag modes: low (desiccate) and high (fulgurate)
• The REM Contact Quality Monitoring System
• Handswitch or footswitch activation
• User selectable coag settings
• User selectable default settings
• Adjustable activation tone volume
• An RF activation port and RS-232 serial port
• Argon Gas Delivery Unit II system compatibility
• Tilt support provided by the bottom mounted handle or use with Covidien carts
Covidien electrosurgical generators, patient return electrodes, and active accessories are
designed to work as a system. Covidien offers a selection of patient return electrodes and
electrosurgical instruments that are fully compatible with this generator. When
considering other manufacturer’s patient return electrodes and/or active accessories,
customers should seek detailed user instructions and warning information from the
manufacturer.

Instant Response Technology


The Force EZ-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

Introduction
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

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

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 PolyhesiveTM patient return electrode may
compromise the REM safety feature. This could result in a patient burn.

How the REM System Works


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

Electrodes Without the REM Safety Feature


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

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

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


Special Features

Introduction
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 Vrms).
• Low 3 uses a slightly higher voltage (300 Vrms) than the low 2 setting, but offers
comparable desiccation.

High (Fulgurate) Coag Settings


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

Recall of Most Recently Used Modes and Power Settings


When you activate this feature, the generator will, when turned on, revert to the most
recently used modes and power settings.

Default Coag Mode


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

You can select either low (desiccate) or high (fulgurate) as the default coag mode for the
Force EZ-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

Front Panel
Footswitch
indicators REM alarm
indicator

Bipolar controls Cut controls Coag controls

Footswitch Monopolar
selector footswitching
button accessory
Bipolar
receptacle
instrument Patient return
receptacle Footswitch electrode receptacle
receptacle For monopolar
Monopolar electrosurgery, connect
Power switch footswitching or a patient return
This switch supplies handswitching electrode to this
power to the instrument receptacle.
generator. 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 Controls
Bipolar display
Shows the power setting, in Bipolar indicator
watts, for standard bipolar When you activate bipolar, this
mode. 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

Bipolar Instrument Receptacle


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

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


Bipolar instrument receptacle.

Connect a footswitching instrument with a two-pin connector.


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

Footswitch Receptacle, Button, and Indicators


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

Use only a Valleylab monopolar footswitch with the Force EZ-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

Monopolar Cut Controls


Cut display Cut indicator
Shows the power setting, in When you activate cut, this bar
watts, for cut output. illuminates yellow and an
activation tone sounds.

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

Controls, Indicators and


Receptacles
Blend Button
Select for slower
cutting and
additional
hemostasis.

Cut 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 2-5


Monopolar Coag Controls

Monopolar Coag Controls


Coag indicator
Coag display When you activate the generator in
Shows the power coag mode, this bar illuminates blue
setting, in watts, for and an activation tone sounds.
coag output.

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

Monopolar Instrument Receptacles

Warning

Controls, Indicators and


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.

Receptacles
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.

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

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

Rear Panel
Volume control
Power entry module

Controls, Indicators and


Receptacles
Option panel
Bipolar Footswitch
receptacle
Equipotential grounding lug
Use to connect the generator to
Monopolar Footswitch
earth ground.
receptacle

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


Footswitch Receptacles

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

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.

Controls, Indicators and


Power cord receptacle

Receptacles
Activation Tone Volume Control
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

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

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


General

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 [N2O] atmospheres).
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.

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

Patient and Operating Room


sealed to prevent oxygen leaks. Enriched oxygen atmospheres may result in fires and burns to
patients or the surgical team.

Safety
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

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.

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


General

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.

Patient and Operating Room


Safety

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


Before Surgery

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


Before Surgery

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
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.

Patient and Operating Room


Fire Hazard Do not use extension cords.

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.

Safety
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.

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


During Surgery

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.

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.

Patient and Operating Room


• 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).

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


During Surgery

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.

Patient and Operating Room


• 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.

Safety
• 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.

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


After Surgery

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

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

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
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.

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.

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.

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,
and either the LOW button indicator or the HIGH button indicator illuminates
green.
– The right arrow indicator at the Footswitch Selector button 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

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.

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 electric shock to the patient or surgical team.

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
Before Surgery

handswitching Bipolar footswitch


instrument

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.

Before Surgery

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


Preparing for Monopolar 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.

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.

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.

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

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.

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


Preparing for Monopolar Surgery

Monopolar connections (handswitching instrument)

Handswitching instrument

Patient return electrode

Monopolar connections (footswitch activation from the Monopolar Footswitch receptacle


on the rear panel)

Handswitching Valleylab monopolar


or footswitching footswitch
instrument
Before Surgery

Patient return
electrode

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
Press the Footswitch
instrument
Selector button until the
Patient return right arrow indicator
electrode illuminates green.

Applying a Patient Return Electrode to the Patient


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.

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
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.

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
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.

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

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.

Cut Coag Coag


Special Action Cut Button Display Button
Feature Display Indicator Indicator

Low 1. Press the LOW button. ––– blank 1, 2, or 3 LOW


(desiccate) flashes
2. Turn the Coag Power
coag
Control knob to select
settings
the desired setting:
1 = low 1 (default)
2 = low 2
3 = low 3

High 1. Press the HIGH button. ––– blank 1 or 2 HIGH


(fulgurate) flashes
2. Turn the Coag Power
coag
Control knob to select
settings
the desired setting:
1 = high 1
2 = high 2 (default)

Recall of 1. Press the PURE button. 0 or 1 PURE ––– blank


most flashes
Before Surgery

2. Turn the Cut Power


recently
Control knob to turn on
used
or turn off this feature:
modes and
power 0 = off
settings 1 = on (default)

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


Setting Up the Special Features

Cut Coag Coag


Special Action Cut Button Display Button
Feature Display Indicator Indicator

Default Press the LOW button. ––– blank 1, 2, or 3 LOW


coag mode flashes
or
Press the HIGH button. ––– blank 1 or 2
(default) HIGH
flashes

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 Press the PURE and BLEND The generator resets all modes, power settings,
default buttons simultaneously. and special features to the original factory
settings defaults.
A tone sounds.

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

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
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.

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

During Surgery
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.

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.

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.
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
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.

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


Activating the Surgical Instrument

During Surgery
Power Surgical Procedure

Low Power Dermatology


< 30 watts
Laparoscopic sterilization (both bipolar and monopolar)
Neurosurgery (both bipolar and monopolar)
Oral surgery
Plastic surgery
Polypectomy
Vasectomy

Medium Power General surgery


Cut: 30–60 watts
Head and neck surgery (ENT)
Coag: 30–70 watts
Laparotomy
Orthopedic surgery (major)
Thoracic surgery (routine)
Vascular surgery (major)

High Power Ablative cancer surgery, mastectomies, etc.


Cut: > 60 watts (cut 60–120 watts; coag 70–120 watts)
Coag: > 70 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

Activation Indicators
Handswitching Footswitching Activation Indicator

Bipolar Close forceps tines Bipolar footswitch Activation tone sounds –


firmly connected to rear Bipolar indicator illuminates
panel – press pedal blue
or
Monopolar
footswitch
connected to front
panel – verify that
the left arrow at the
Footswitch Selector
button illuminates
and press either
pedal

Monopolar Press CUT or COAG Monopolar Activation tone sounds – Cut


button footswitch indicator illuminates yellow
connected to front or Coag indicator illuminates
or
panel – verify that blue
Close forceps tines the right arrow at
firmly the Footswitch
Selector button
illuminates and press
the cut or coag
pedal
or
Monopolar
footswitch
connected to rear
panel – press the cut
or coag pedal

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

During Surgery
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:
• 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

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

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

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.
or
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

Troubleshooting
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

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

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 Metal-to-metal sparking Check all connections to the


stimulation (stop surgery generator, patient return
immediately) electrode, and active
electrodes.

Can occur during coag (more Use a lower power setting for
likely when fulgurating than the high (fulgurate) mode or
when cutting, and unlikely select the low (desiccate)
when desiccating) mode.

Abnormal 50–60 Hz leakage Refer to your Biomedical


currents Engineering Department or
contact a Covidien
Representative for assistance.

Generator does not Disconnected power cord or Check power cord connections
respond when turned on faulty wall outlet (generator and wall outlet).
Connect the power cord to a
functional outlet.

Faulty power cord Replace the power cord.

Fuse drawer is open or fuses Close the fuse drawer. Replace


are blown the blown fuse(s). Refer to the
Force EZ Electrosurgical
Generator C/8C Service
Manual.

Internal component Use a backup generator. Refer


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

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


Correcting Malfunctions

Situation Possible Cause Solution

Generator is on, but did Software malfunction Turn off, then turn on the
not complete the self-test generator.

Internal component Use a backup generator. Refer


malfunction 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 Malfunctioning footswitch or Turn off the generator. Check


accessory is activated, but handswitching instrument and correct all accessory
generator does not deliver connections.
output
Turn on the generator. Replace
the accessory if it continues to
malfunction.

Incompatible footswitch Use only a Valleylab monopolar


footswitch with the Force EZ-C
generator.

Footswitch is connected to 1. Verify all accessory


front panel Footswitch connections.
receptacle, but arrow indicator
2. Press the Footswitch
at Footswitch Selector button
Selector button to
does not indicate desired
illuminate the arrow
instrument receptacle
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 • Connect the footswitch to


panel Footswitch receptacle is the rear panel Monopolar
being used for surgical Footswitch receptacle.
instrument connected to
or
Monopolar Footswitching or
Handswitching Instrument • If you are using a
receptacle footswitching instrument,
connect it to the Accessory
receptacle.

Footswitch connected to rear • Connect the footswitch to


panel Monopolar Footswitch the front panel Footswitch
receptacle is being used for receptacle
instrument connected to
or
Monopolar Footswitching
Accessory receptacle • Connect the instrument to
the Monopolar
Footswitching or
Handswitching Instrument
receptacle.

Continued on next page

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


Correcting Malfunctions

Situation Possible Cause Solution

Generator is on and Power is set too low Increase the power setting.
accessory is activated, but Refer to Changing the Power
generator does not deliver Setting on page 5-3
output
Continued 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

Continuous monitor Faulty chassis-to-ground 1. Check and correct the


interference connections chassis ground connections
for the monitor and for the
generator.
2. Check other electrical
equipment in the room for
defective grounds.

Electrical equipment is Plug all electrical equipment


grounded to different objects into line power at the same
rather than a common ground. location. Contact your
The generator may respond to Biomedical Engineering

Troubleshooting
the resulting voltage Department or a Covidien
differences between grounded Representative for assistance.
objects.

Malfunctioning monitor Replace the monitor.

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


Correcting Malfunctions

Situation Possible Cause Solution

Interference with other Metal-to-metal sparking Check all connections to the


devices only when the generator, patient return
generator is activated electrode, and accessories.

High settings used for Use lower power settings for


fulguration high (fulguration) mode or
select the low (desiccate)
mode.

Electrically inconsistent ground Verify that all ground wires are


wires in the operating room as short as possible and go to
the same grounded metal.

If interference continues when Ask your Biomedical


the generator is activated, the Engineering Department to
monitor is responding to check with the manufacturer of
radiated frequencies. 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


Correcting Malfunctions

Situation Possible Cause Solution

Pacemaker interference Intermittent connections or Check the active and patient


metal-to-metal sparking return electrode cord
connections.
It may be necessary to
reprogram the pacemaker.

Current traveling from active to Use bipolar instruments, if


return electrode during possible.
monopolar electrosurgery is
If you must use a monopolar
passing too close to
instrument, place the patient
pacemaker.
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

Troubleshooting
of electrosurgical appliances is
planned in patients with
cardiac pacemakers.

Internal Cardiac ICD is activated by Stop the procedure and


Defibrillator (ICD) electrosurgical generator. contact the ICD manufacturer
activation for instructions.

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


Responding to System Alarms

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 Diagnostic/microcontroller Contact your Biomedical Engineering


16 malfunction Department.

17-19 Internal component Do not attempt to use the generator. Record


malfunction the number and call the Covidien Service
Center.

30-32 Software malfunction Turn off, then turn on the generator. If the
40 alarm number reappears, record the number
50-51 and call the Covidien Service Center.
54-55
57-66

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


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

68 Microcontroller malfunction Contact your Biomedical Engineering


Department.

69-71 Software malfunction Turn off, then turn on the generator. If the
80 alarm number reappears, record the number
and call the Covidien Service Center.

81 Internal component Do not attempt to use the generator. Record


malfunction the number and call the Covidien Service
Center.

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


Responding to System Alarms

Number Description Recommended Action

90 Microcontroller malfunction Contact your Biomedical Engineering


95 Department.

100-105 Software malfunction Turn off, then turn on the generator. If the
109-119 alarm number reappears, record the number
and call the Covidien Service Center.

120 Calibration malfunction Contact your Biomedical Engineering


Department.

121 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record the number
and call the Covidien Service Center.

122 Calibration malfunction Contact your Biomedical Engineering


Department.

123-126 Microcontroller malfunction Contact your Biomedical Engineering


Department.

127-128 Internal component Do not attempt to use the generator. Record


malfunction the number and call the Covidien Service
Center.

129-140 Software malfunction Turn off, then turn on the generator. If the

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

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 Contact your Biomedical Engineering


malfunction 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
the number and call the Covidien Service
Center.

164-166 Dosage error Contact your Biomedical Engineering


Department.

170-173 Microcontroller malfunction Contact your Biomedical Engineering


Department.

174 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record the number
and call the Covidien Service Center.

180-185 Internal diagnostics Contact your Biomedical Engineering


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/ Turn off, then turn on the generator. Ensure
or BLEND) may be stuck that no buttons or accessory activation devices
are pressed during the self-test.
192 Coag mode buttons (LOW If the alarm number reappears, disconnect all
and/or HIGH) may be stuck accessories. Then, turn off and turn on the
generator again. If the alarm number
193 Front panel Footswitch button reappears, record the number and call the
may be stuck Covidien Service Center.

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

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 Do not attempt to use the generator. Record


malfunction the number and call the Covidien Service
Center.

215-216 Internal diagnostics Contact your Biomedical Engineering


Department.

220-221 Diagnostics / microcontroller Contact your Biomedical Engineering

Troubleshooting
223-226 malfunction Department.

230-231 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record the number
and call the Covidien Service Center.

232 Microcontroller malfunction Contact your Biomedical Engineering


Department.

233 Software malfunction Turn off, then turn on the generator. If the
240-242 alarm number reappears, record the number
244-245 and call the Covidien Service Center.

246-247 Microcontroller malfunction Contact your Biomedical Engineering


Department.

260 Internal diagnostics Contact your Biomedical Engineering


Department.

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


Number Description Recommended Action

261-262 Software malfunction Turn off, then turn on the generator. If the
270-271 alarm number reappears, record the number
and call the Covidien Service Center.

451 The internal temperature limit Verify that the location of the generator allows
was exceeded due to length of for adequate cooling.
activation time.
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

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

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.
Maintenance and Repair

The generator cannot be sterilized.

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

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)


each

Mounting Universal Mounting cart (UC8009) or any stable flat


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 50° to 104° F (10° to 40° C)


range

Relative humidity 30% to 75%, noncondensing

Atmospheric pressure 700 to 1060 millibars

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


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


Performance Characteristics

Technical Specifications
Transport and Storage

Ambient temperature -29° to 149° F (-34° to 65° C)


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
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 ≥ 65 dBA

Frequency Bipolar: 554 Hz


Cut: 440 Hz
Coag: 554 Hz

Duration Continuous while the generator is activated

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


Performance Characteristics

Technical Specifications
Alarm Tone

Volume (not ≥ 65 dBA


adjustable)

Frequency 440 Hz

Duration 250 to 500 ms

REM Contact Quality Monitor


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

Measurement 80 kHz ± 10 kHz


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).
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 Pin 2 – isolated transmit (serial data output transmit line)
supports the
Pin 3 – isolated receive (serial data input receive line)
following signals
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 < 100 μA


current, ground open

Source current, Normal polarity, intact ground: < 10 μA


patient leads, all
Normal polarity, ground open: < 50 μA
outputs
Reverse polarity, ground open: < 50 μA

Sink current at high < 20 μA


line, all inputs

High Frequency (RF) Leakage Current

Bipolar RF leakage < 60 mArms


current

Monopolar RF leakage < 150 mArms


current

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


Performance Characteristics

Technical Specifications
Input Power

100–120 Volt 220–240 Volt

Maximum VA at nominal line voltage: Maximum VA at nominal line voltage:


Idle: 50 VA Idle: 50 VA
Bipolar: 500 VA Bipolar: 500 VA
Cut: 850 VA Cut: 850 VA
Coag: 500 VA Coag: 500 VA

Input mains voltage, full regulation Input mains voltage, full regulation
range: 90–135 Vac range: 186–264 Vac

Input mains voltage, operating range: Input mains voltage, operating range:
85–140 Vac 170–280 Vac

Mains current (maximum): Mains current (maximum):


Idle: 0.4 A Idle: 0.2 A
Bipolar: 4.2 A Bipolar: 2.1 A
Cut: 8.0 A Cut: 4.0 A
Coag: 4.2 A Coag: 2.1 A

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

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

Power cord: 3-prong hospital grade Power cord: 3-prong locally approved
connector 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

Technical Specifications
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.

F 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

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.

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.

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 60601-
2-2 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 60601-
2-2 (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

Technical Specifications
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.

Open Crest
Circuit P-P Rated Load Factora
Mode Voltage (max) Power (typical @
(max) (max) Rated Load)

Bipolar 300 V 100 Ω 70 W 1.5

Monopolar
Cut
Pure 2000 V 300 Ω 300 W 1.5
Blend 3400 V 300 Ω 200 W 2.1

Monopolar
Coag

Low 1 3500 V 500 Ω 120 W 5.0


Low 2 660 V 300 Ω 120 W 1.5
Low 3 1100 V 300 Ω 120 W 1.5
High 1 6000 V 500 Ω 120 W 4.9
High 2 8500 V 500 Ω 120 W 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

1 2 3 4 5 6 7 8 9 10

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

1 2 3 4 5 6 7 8 9 10

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


Output Characteristics

Technical Specifications
Monopolar Cut: Blend

1 2 3 4 5 6 7 8 9 10

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

Monopolar Coag

1 2 3 4 5 6 7 8 9 10

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

Standard 470 kHz sinusoid

Monopolar Cut

Pure 393 kHz sinusoid

Blend 393 kHz bursts of sinusoid recurring at 27.1 kHz


intervals, 50% duty cycle

Monopolar Coag

Desiccation
Low 1 240 ± 40 kHz sinusoid recurring at 39 kHz. 8% duty
cycle at open load
Low 2 393 kHz sinusoid
Low 3 393 kHz sinusoid

Fulguration
High 1 470 kHz damped sinusoidal bursts with a repetition
frequency of 57 kHz at open load
High 2 470 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

Technical Specifications
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
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

Technical Specifications
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)

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


Output Power vs. Resistance Graphs

Technical Specifications
Monopolar Coag Graphs
The procedures described in IEC 60601-2-2 and full length leads were used to obtain the
monopolar coag output measurements.
Low 1 (Desiccate) 60W mode — load resistance vs. output power
Output Power (watts)

Load Resistance (ohms)

Low 1 (Desiccate) 120W mode — load resistance vs. output power


Output Power (watts)

Load Resistance (ohms)

Force EZ Electrosurgical Generator C User’s Guide 9-19


Output Power vs. Resistance Graphs

Low 2 (Desiccate) 60W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

Low 2 (Desiccate) 120W mode — load resistance vs. output power


Output Power (watts)

Load Resistance (ohms)

9-20 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Resistance Graphs

Technical Specifications
Low 3 (Desiccate) 60W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

Low 3 (Desiccate) 120W mode — load resistance vs. output power


Output Power (watts)

Load Resistance (ohms)

Force EZ Electrosurgical Generator C User’s Guide 9-21


Output Power vs. Resistance Graphs

High 1 (Fulgurate) 60W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

High 1 (Fulgurate) 120W mode — load resistance vs. output power


Output Power (watts)

Load Resistance (ohms)

9-22 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Resistance Graphs

Technical Specifications
High 2 (Fulgurate) 60W mode — load resistance vs. output power

Output Power (watts)

Load Resistance (ohms)

High 2 (Fulgurate) 120W mode — load resistance vs. output power


Output Power (watts)

Load Resistance (ohms)

Force EZ Electrosurgical Generator C User’s Guide 9-23


Output Power vs. Generator Settings

Output Power vs. Generator Settings


Standard Bipolar mode @ 100 ohms — generator setting vs. output power
70

60

50
Output Power (watts)

40

30

20

10

0
0 10 20 30 40 50 60 70

Generator Setting

Standard Bipolar mode — peak voltage vs. output power


140

120
Open Circuit Peak Voltage (volts)

100

80

60

40

20

0
1 10 20 30 40 50 60 70

Output Power (watts)

9-24 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Generator Settings

Technical Specifications
Pure mode @ 300 ohms — generator setting vs. output power
300

250
Output Power (watts)

200

150

100

50

0
0 100 200 300
Generator Setting

Pure mode — peak voltage vs. output power


1000
Open Circuit Peak Voltage (volts)

800

600

400

200

0
1
20
40
60
80
100
120
140
160
180
200
220
240
260
280
300

Output Power (watts)

Force EZ Electrosurgical Generator C User’s Guide 9-25


Output Power vs. Generator Settings

Blend mode @ 300 ohms — generator setting vs. output power


200

180

160
Output Power (watts)

140

120

100

80

60

40

20

0
0 50 100 150 200
Generator Setting

Blend mode — peak voltage vs. output power


1600

1400
Open Circuit Peak Voltage (volts)

1200

1000

800

600

400

200

0
1

20

40

60

80

100

120

140

160

180

200

Output Power (watts)

9-26 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Generator Settings

Technical Specifications
Low 1 (Desiccate) mode @ 500 ohms — generator setting vs. output power

Output Power (watts)

Generator Setting

Low 1 (Desiccate) mode — peak voltage vs. output power


2500
Open Circuit Peak Voltage (volts)

2000

1500

1000

500

0
1 10 20 30 40 50 60 70 80 90 100 110 120

Output Power (watts)

Force EZ Electrosurgical Generator C User’s Guide 9-27


Output Power vs. Generator Settings

Low 2 (Desiccate) mode @ 300 ohms— generator setting vs. output power
120

100

80
Output Power (watts)

60

40

20

0
0 20 40 60 80 100 120
Generator Setting

Low 2 (Desiccate) mode — peak voltage vs. output power


300
Open Circuit Peak Voltage (volts)

250

200

150

100

50

0
1 10 20 30 40 50 60 70 80 90 100 110 120

Output Power (watts)

9-28 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Generator Settings

Technical Specifications
Low 3 (Desiccate) mode @ 300 ohms— generator setting vs. output power

Output Power (watts)

Generator Setting

Low 3 (Desiccate) mode — peak voltage vs. output power


500
450
Open Circuit Peak Voltage (volts)

400
350
300
250
200
150
100
50
0
1 10 20 30 40 50 60 70 80 90 100 110 120

Output Power (watts)

Force EZ Electrosurgical Generator C User’s Guide 9-29


Output Power vs. Generator Settings

High 1 (Fulgurate) mode @ 500 ohms— generator setting vs. output power

Output Power (watts)

Generator Setting

High 1 (Fulgurate) mode — peak voltage vs. output power


3500

3000

2500

2000
Open Circuit Peak

1500

1000

500

0
1 10 20 30 40 50 60 70 80 90 100 110 120

Output Power (watts)

9-30 Force EZ Electrosurgical Generator C User’s Guide


Output Power vs. Generator Settings

Technical Specifications
High 2 (Fulgurate) mode @ 500 ohms— generator setting vs. output power

120

Output Power (watts) 100

80

60

40

20

0
0 20 40 60 80 100 120
Generator Setting

High 2 (Fulgurate) mode — peak voltage vs. output power


4500
4000
Open Circuit Peak Voltage (volts)

3500
3000
2500
2000
1500
1000
500
0
1 10 20 30 40 50 60 70 80 90 100 110 120

Output Power (watts)

Force EZ Electrosurgical Generator C User’s Guide 9-31

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