Professional Documents
Culture Documents
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)
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.
ValleylabTM Argon Gas Delivery Unit II One year from date of shipment
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.
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.
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.
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.
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.
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.
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.
Monopolar Pure
This chapter describes the front and rear panels, including all controls, indicators,
receptacles, the fuse drawer, and ports.
Front Panel
Footswitch
indicators REM alarm
indicator
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).
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.
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.
Pure Button
Select for an even
cut with little or no
hemostasis.
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.
Warning
Receptacles
Monopolar Footswitching Accessory Receptacle
Connect a monopolar footswitching instrument with a single-pin connector to this
receptacle.
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.)
Rear Panel
Volume control
Power entry module
Footswitch Receptacles
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.
The footswitch will not activate instruments connected to the Monopolar Instrument or
Monopolar Footswitching Accessory receptacles on the front panel.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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
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.
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.
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.
Safety
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
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.
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.
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.
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.
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.
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.
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.
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
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.
Handswitching
instrument
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
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.
Handswitching instrument
Patient return
electrode
Monopolar
instrument
Footswitching
Press the Footswitch
instrument
Selector button until the
Patient return right arrow indicator
electrode illuminates green.
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.
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
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.
Mode Power
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.
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.
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.
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.
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.
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.
During Surgery
Power Surgical Procedure
Activation Indicators
Handswitching Footswitching Activation Indicator
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.
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.
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.
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.
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
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.
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.
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
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.
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.
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.
Generator is on, but did Software malfunction Turn off, then turn on the
not complete the self-test generator.
Troubleshooting
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
Troubleshooting
the resulting voltage Department or a Covidien
differences between grounded Representative for assistance.
objects.
Troubleshooting
of electrosurgical appliances is
planned in patients with
cardiac pacemakers.
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
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.
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.
121 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record 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.
152 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record the number
and call the Covidien Service Center.
161, 163 Dosage error Do not attempt to use the generator. Record
the number and call the Covidien Service
Center.
174 Software malfunction Turn off, then turn on the generator. If the
alarm number reappears, record the number
and call the Covidien Service Center.
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.
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.
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.
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.
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.
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
Routine Maintenance
Notice
Refer to the generator service manual for maintenance recommendations and function and
output power verification procedures.
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
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
Performance Characteristics
General
Operating Parameters
Technical Specifications
Transport and Storage
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
Internal Memory
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
Technical Specifications
Alarm Tone
Frequency 440 Hz
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.
Technical Specifications
Input Power
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 line frequency range (nominal): Mains line frequency range (nominal):
50 Hz to 60 Hz 50 Hz to 60 Hz
Power cord: 3-prong hospital grade Power cord: 3-prong locally approved
connector connector
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
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.
DANGER
Explosion risk if used with flammable anesthetics.
Non-Ionizing Radiation
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.
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.
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
Open Crest
Circuit P-P Rated Load Factora
Mode Voltage (max) Power (typical @
(max) (max) Rated Load)
Monopolar
Cut
Pure 2000 V 300 Ω 300 W 1.5
Blend 3400 V 300 Ω 200 W 2.1
Monopolar
Coag
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
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
190 200 210 220 230 240 250 260 270 280
290 300
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
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
Output Waveforms
Instant Response technology, an automatic adjustment, controls the bipolar mode, the
cut modes, and the low 2 and low 3 coag settings. It does not control the low 1, high 1,
and high 2 coag modes.
As tissue resistance increases from zero, the generator outputs constant current followed
by constant power followed by constant voltage. The maximum output voltage is
controlled to reduce capacitive coupling and video interference and to minimize sparking.
Bipolar
Monopolar Cut
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
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)
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.
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)
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)
Technical Specifications
Low 3 (Desiccate) 60W mode — load resistance vs. output power
Technical Specifications
High 2 (Fulgurate) 60W mode — load resistance vs. output power
60
50
Output Power (watts)
40
30
20
10
0
0 10 20 30 40 50 60 70
Generator Setting
120
Open Circuit Peak Voltage (volts)
100
80
60
40
20
0
1 10 20 30 40 50 60 70
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
800
600
400
200
0
1
20
40
60
80
100
120
140
160
180
200
220
240
260
280
300
180
160
Output Power (watts)
140
120
100
80
60
40
20
0
0 50 100 150 200
Generator Setting
1400
Open Circuit Peak Voltage (volts)
1200
1000
800
600
400
200
0
1
20
40
60
80
100
120
140
160
180
200
Technical Specifications
Low 1 (Desiccate) mode @ 500 ohms — generator setting vs. output power
Generator Setting
2000
1500
1000
500
0
1 10 20 30 40 50 60 70 80 90 100 110 120
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
250
200
150
100
50
0
1 10 20 30 40 50 60 70 80 90 100 110 120
Technical Specifications
Low 3 (Desiccate) mode @ 300 ohms— generator setting vs. output power
Generator Setting
400
350
300
250
200
150
100
50
0
1 10 20 30 40 50 60 70 80 90 100 110 120
High 1 (Fulgurate) mode @ 500 ohms— generator setting vs. output power
Generator Setting
3000
2500
2000
Open Circuit Peak
1500
1000
500
0
1 10 20 30 40 50 60 70 80 90 100 110 120
Technical Specifications
High 2 (Fulgurate) mode @ 500 ohms— generator setting vs. output power
120
80
60
40
20
0
0 20 40 60 80 100 120
Generator Setting
3500
3000
2500
2000
1500
1000
500
0
1 10 20 30 40 50 60 70 80 90 100 110 120