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Operator’s Manual

TM

E L E C T R O S U R G I C A L U N I T
LIMITED WARRANTY
For a period of two years following the date of delivery,
CONMED Corporation warrants the CONMED System
5000™ Electrosurgical Generator against any defects in
material or workmanship and will repair or replace (at
CONMED’s option) the same without charge, provided
that routine maintenance as specified in this manual has
been performed using replacement parts approved by
CONMED. This warranty is void if the product is used
in a manner or for purposes other than intended.

© 2007 CONMED Corporation


525 French Road
Utica, New York 13502 U.S.A.

U.S. Patent Nos. 4,961,739 - 5,152,762 - 5,626,575-


6,830,569 - 6,835,082 - 6,875,210 - 6,939,347 -
D477,082 - D477,408.

For Technical Service or Return Authorization Phone:


303-699-7600 / 1-800-552-0138 Extension 5274
Fax 303-699-1628

For Customer Service or to order parts phone:


1-800-448-6506 / 315-797-8375 / Fax 315-735-6235
or contact your CONMED Representative.

European Authorized Representative


MDSS GmbH
Schiffgraben 41
D - 30175 Hannover
Germany

The revision level of this manual is specified by the


highest revision letter found on either the inside front cover
or enclosed errata pages (if any).

Manual Number 60-8016-ENG Rev. N 11/07

Unit Serial Number


Table of Contents
& List of Illustrations

Section Title Page


1.0 General Information..............................................................................1-1
1.1 Cautions...............................................................................................................1-1
1.1.1 Cautions For Equipment Preparation......................................................................................1-2
1.1.2 Cautions For Patient Preparation.............................................................................................1-2
1.1.3 Cautions For Use.........................................................................................................................1-4
1.1.4 Cautions For Testing or Servicing.............................................................................................1-5
1.1.5 Electromagnetic Compatibility..................................................................................................1-6
1.1.5.1 EN/IEC 60601-1-2 Table 201....................................................................................................1-6
1.1.5.2 EN/IEC 60601-1-2 Table 202....................................................................................................1-7
1.1.5.3 EN/IEC 60601-1-2 Table 204....................................................................................................1-8
1.1.5.4 EN/IEC 60601-1-2 Table 206....................................................................................................1-9
1.2 Specifications......................................................................................................1-9
1.2.1 Mains Overcurrent Protection...................................................................................................1-9
1.2.2 Mains Frequency Leakage..........................................................................................................1-9
1.2.3 Regulatory Compliance.............................................................................................................1-10
1.2.4 Operation..............................................................................................................................1-10
1.2.5 Power Display Accuracy............................................................................................................1-10
1.2.6 Line Regulation..........................................................................................................................1-10
1.2.7 Environmental............................................................................................................................1-10
1.2.8 Contact Quality Monitor...........................................................................................................1-10
1.2.9 Audio Specifications..................................................................................................................1-10
1.2.10 Other Specifications...................................................................................................................1-11
1.2.11 Operating Modes and Nominal Output Parameters.............................................................1-11
1.3 Explanation of Symbols........................................................................................1-12
1.3.1 Control Panel..............................................................................................................................1-12
1.3.2 Interior...................................................................................................................................1-12
1.3.3 Output/Control Panel................................................................................................................1-12
1.3.4 Rear Panel...................................................................................................................................1-13
1.4 Output Characteristic Curves........................................................................1-14
2.0 Installation and Operation.........................................................................2-1
2.1 Initial Inspection................................................................................................2-1
2.2 Installation..........................................................................................................2-1
2.2.1 Installation Of Fuses...................................................................................................................2-1
2.3 Preliminary Checks.................................................................................................2-1
2.3.1 Preliminary Functional Testing.................................................................................................2-1
2.3.2 Preliminary Performance Testing.............................................................................................2-3
2.4 Controls, Displays and Connectors.......................................................................2-3
2.4.1 Control Panel...............................................................................................................................2-3
2.4.2 Output Panel................................................................................................................................2-5
2.4.3 Rear Panel....................................................................................................................................2-6
2.5 Set Up For Use...................................................................................................2-7
2.6 Operation..........................................................................................................2-10
2.6.1 General........................................................................................................................................2-10
2.6.2 Monopolar Pulse Cut................................................................................................................2-10
Section Title Page
2.6.3 Monopolar Pulse Coag..............................................................................................................2-11
2.6.4 Fluids Specialty Mode...............................................................................................................2-11
2.6.5 Lap Specialty Mode....................................................................................................................2-11
2.6.6 Programming........................................................................................................................2-11
2.6.6.1 Storing Programs.......................................................................................................................2-11
2.6.6.2 Using Programs..........................................................................................................................2-11
2.6.7 Remote Power Control............................................................................................................2-11
2.6.7.1 Changing Monopolar Power Remotely..................................................................................2-12
2.7 User Maintenance.................................................................................................2-12
2.7.1 General Maintenance Information.........................................................................................2-12
2.7.2 Cleaning.......................................................................................................................................2-12
2.7.3 Periodic Inspection....................................................................................................................2-12
2.7.4 Periodic Performance Testing.................................................................................................2-12
2.8 In Case of Difficulty.........................................................................................2-12
2.8.1 Dispersive Electrode Alarm.....................................................................................................2-12
2.8.1.1 Single Dispersive Electrode Alarm.........................................................................................2-12
2.8.1.2 Dual Dispersive Electrode Alarm............................................................................................2-13
2.8.2 Acc Codes....................................................................................................................................2-13
2.8.3 Err Codes....................................................................................................................................2-13
2.8.4 If All Else Fails...........................................................................................................................2-13
2.9 Environmental Protection....................................................................................2-13
Figure/Title Page
Figure 1.1 Output Power vs. Power Setting..........................................................................................1-14
Figure 1.2 Display vs. Open Circuit Peak Voltage......................................................................................1-14
Figure 1.3 Load Regulation, Monopolar Pure Cut.....................................................................................1-15
Figure 1.4 Load Regulation, Monopolar Blend 1.................................................................................1-15
Figure 1.5 Load Regulation, Monopolar Blend 2.......................................................................................1-16
Figure 1.6 Load Regulation, Monopolar Blend 3.......................................................................................1-16
Figure 1.7 Load Regulation, Monopolar Pinpoint Coag.....................................................................1-17
Figure 1.8 Load Regulation, Monopolar Standard Coag...........................................................................1-17
Figure 1.9 Load Regulation, Monopolar Spray Coag.................................................................................1-18
Figure 1.10 Load Regulation, Bipolar Micro...............................................................................................1-18
Figure 1.11 Load Regulation, Bipolar Macro........................................................................................1-19
Figure 1.12 Load Regulation, Lap Spray......................................................................................................1-19
Figure 1.13 Load Regulation, Lap Standard...............................................................................................1-20
Figure 2.1 Control Panel..................................................................................................................................2-4
Figure 2.2 Output Panel..................................................................................................................................2-6
Figure 2.3 Rear Panel.......................................................................................................................................2-7
Figure 2.4 Accessory Schematics..................................................................................................................2-14
Figure 2.5 Accessory Connections................................................................................................................2-14
General Information
Section 1.0

This manual provides the set up and operating


Features include:
instructions for the System 5000™ Electrosurgical
Unit (ESU). Electrosurgery can be dangerous • Dynamic Response Technology delivers opti-
to patients, staff and other equipment if mis- mal clinical effects in all operational modes
used. Please understand and follow the warnings through the continuous synchronization of
and cautions that are included in this manual. current and voltage.
Technical specifications, performance • Bipolar Output Meter provides visual and
characteristic curves and user maintenance audible feedback to surgeon during tubal liga-
instructions are also included. tions, vasectomies, and other procedures.
The System 5000™ provides a broad range • ReadiPlug™ universal accessory receptacle
of capabilities in a single, general-purpose eliminates the need for foot-controlled adapt-
electrosurgical generator. This rugged ESU fulfills ers.
the operational and safety needs of the modern • Nine programmable memory settings provide
operating room by providing: set-up convenience.
• Four monopolar cutting modes: Pure, Blend • Automatic programming restores the ESU to
1, Blend 2 and Blend 3. the last settings used.
• Three monopolar coagulation modes: Spray, • Remote Power Control (PC) allows power
Standard and Pinpoint. set- ting changes using standard hand-
• Two bipolar modes: Micro and Macro controlled pencils.
• Two specialty modes and a general surgery • Independent power setting available for all
mode: modes.
• General Mode provides full power perfor- • Ability to change power settings from the
mance for open surgical procedures. con- trol panel while the ESU is activated.
• Fluids Specialty Mode provides immediate • Two handswitched receptacles and a separate
energy delivery for procedures performed footswitched receptacle enable multiple acces-
in a fluid medium. sory connections.
• Laparoscopic Specialty Mode provides • Simultaneous activation in non-contact
optimal safety by limiting output voltage monopolar coagulation modes.
and minimizing the potential harmful • Channeled accessory receptacles direct plugs
effects of capacitive coupling. into position, making attachments less cum-
• Pulse Cut Mode provides precise modulated bersome.
energy delivery for critical dissection. • Illuminated receptacles for greater visibility.
• Pulse Coagulation Mode provides a modulated • Integrated operating room control system
waveform for unsurpassed precision and con- capability.
trol.
• Integrated interface for activation of smoke
• Radio Frequency (RF) isolated and indepen- evacuators and similar devices.
dent outputs.
• The proven Automatic Return Monitor 1.1 Cautions
(A.R.M.™) contact quality monitoring sys- This equipment, in conjunction with connected
tem. accessories, is intended to produce high-frequency
• Continuous microprocessor safety monitoring. electrical energy for the controlled destruction of
tissue.

1
Safe and effective electrosurgery is dependent not
60-8030-001) allows two System 2500™ or
only on equipment design, but also on factors
System 5000™ units to be stacked in a safe
under the control of the operator. It is
manner.
important that the instructions supplied with this
equipment be read, understood and followed in • Confirm all accessories are properly connected
order to ensure safe and effective use of the to the appropriate receptacles before powering
equipment. the ESU.
• Potentially hazardous conditions may exist
1.1.1 Cautions For Equipment Preparation
when accessories of similar connector types
• Use only accessories that comply with the rel- are combined. Be certain accessories are
evant regulatory standards for your location appropriate for the type of generator output
and meet the requirements of Section 1.2, used. Use only CONMED Electrosurgery
Section 1.4, and Figure 2.4. Use of other footswitches. Confirm bipolar leads are
accessories may result in increased emissions connected only to the bipolar receptacles.
or decreased immunity of the ESU. Connecting bipolar accessories to monopolar
• Reusable accessory cables should be periodi- outputs may result in patient injury.
cally function and safety tested in accordance • Do not reuse disposable (single use) accesso-
with the original manufacturer’s instructions. ries.
• Visually inspect all accessories before each use • Do not use cords as handles as damage to the
to verify the integrity of insulation and the insulation and increased risk of burns or other
absence of obvious defects. In particular, elec- injury may result.
trode cables and endoscopic accessories should • A failure in the ESU could cause an unintend-
be checked for damage to the insulation. ed increase in output power. Verify that the
• The System 5000™ is equipped to connect ESU is functioning correctly prior to use.
three monopolar accessories at one time for • Prior to use, verify that devices connected
the convenience of the surgical staff. Unused to the Activation Relay Connector
accessories should be stowed in a safe, electri- function properly in a manner that is
cally insulated place such as a non-conductive synchronized with ESU power delivery.
holster, isolated from the patient.
• Equipment connected to the Serial Interface
CONMED recommends accessories not be
Connector must be approved by CONMED
connected unless needed.
and must be connected in accordance with
• Never connect more than one accessory at instructions accompanying the equipment.
a time to any one receptacle, not including Verify proper operation prior to ESU use.
the dispersive electrode receptacle when the
appropriate CONMED adapter is used. 1.1.2 Cautions For Patient Preparation
• Use only a hospital grade, 3-prong, power • Electrosurgery should NEVER be performed
cord rated to meet the specifications in in the presence of flammable anesthetics,
Section 1.2 and all of the requirements for flammable prep solutions or drapes, oxidiz-
safe grounding of the ESU. The user should ing gases such as Nitrous Oxide (N2O) or in
verify that the power receptacle with which oxygen-enriched environments. The risk of
this ESU is used is properly grounded, cor- igniting flammable gases or other materials is
rectly polarized and of the proper frequency inherent in electrosurgery and cannot be elim-
per Section 1.2. Do not use ground cheater inated by device design. Precautions must
plugs or extension cords. be taken to restrict flammable materials and
• Do not place liquid containers on top of substances from the electrosurgical site. They
the ESU. Wipe spilled liquids off the ESU may be present in the form of an anesthetic,
immediately. To preclude inadvertent entry of life support, skin preparation agent, produced
liquids, do not operate this ESU except in its by natural processes within body cavities or
normal position. originate in surgical drapes, tracheal tubes or
other materials. There is a risk of pooling
• Do not stack other devices or equipment
on top of or adjacent to the System of flammable solutions in body depressions
5000™. The CONMED Stacking Adapter such as the umbilicus and in body cavities,
(Cat. No.

1-2
such as the vagina. Any fluid pooled in these
electrosurgery. The entire area of the disper-
areas should be removed before the high fre-
sive electrode should be placed so that the
quency surgical equipment is used. Due to
entire conductive area is in firm contact with
the danger of ignition of endogenous gases,
an area of the patient’s body that has a good
the bowel should be purged and filled with
blood supply and is as close to the operative
nonflammable gas prior to abdominal surgery.
site as possible. In general, electrosurgical
To avoid the risk of tracheal fires, never use
current paths should be as short as possible
electrosurgery to enter the trachea during tra-
and should run either longitudinally or in a
cheotomy procedures.
diagonal direction to the body, not laterally
• The System 5000™ mobile pedestal is made of and under no circumstances lateral to the tho-
nonconductive plastic, that can hold a static rax.
charge. It should not be used in a flammable
• Dispersive electrodes and probes of monitor-
environment, as described above.
ing, stimulating and imaging devices can
• Only non-flammable agents should be used for provide paths for high frequency currents
cleaning and disinfection wherever possible. even if they are battery powered, insulated
• Exercise care when relocating the ESU to or isolated at 50/60 Hz. The risk of burns
avoid electrostatic charge buildup in the pres- can be reduced but not eliminated by placing
ence of flammable materials, as there is a risk the probes as far away as possible from the
of igniting these materials if a spark should electrosurgical site and the dispersive elec-
occur. trode. Protective impedances incorporated
• This ESU is equipped with the Automatic in the monitoring leads may further reduce
Return Monitor (A.R.M.™), which monitors the risk of these burns. Needles should not
the quality of the dispersive electrode con- be used as monitoring electrodes during
nection. When a correctly functioning single electrosurgical procedures.
dispersive electrode is connected to the ESU, • When high frequency surgical equipment
A.R.M.™ verifies the connections between the and physiological monitoring equipment are
ESU, the dispersive electrode cable and the used simultaneously on the same patient, all
dispersive electrode. It DOES NOT verify monitoring electrodes should be placed as far
that a single dispersive electrode is in contact as possible from the surgical site and disper-
with the patient. When using a dual disper- sive electrode. Needle monitoring electrodes
sive electrode, A.R.M.™ confirms the total are not recommended. Monitoring systems
resistance is within the preset safety range. incorporating high frequency current limiting
Proper application and visual inspection of the devices are recommended whenever possible.
dispersive electrode is required for safe opera- • The active electrode should not be used in the
tion. vicinity of electrocardiograph electrodes.
• The use and proper placement of a dispersive • Heat applied by thermal blankets or other
electrode is a key element in safe and effec- sources is cumulative with the heat pro-
tive electrosurgery. Follow manufacturer’s duced at the dispersive electrode (caused by
directions and recommended practices for the electrosurgical currents). Choosing a disper-
preparation, placement, use, surveillance and sive electrode site that is remote from other
removal of any dispersive electrode supplied heat sources may minimize risk of a patient
for use with this electrosurgical unit. injury.
• Apply the dispersive electrode over a well-vas- • Electrosurgery, by its nature produces signifi-
cularized muscle mass that is thoroughly clean cant levels of electromagnetic interference
and dry. Clean and clip site, as necessary, to (EMI) when the ESU is activated. This EMI
provide adequate electrical connection and per may damage or impair the function of other
hospital policy. Avoid placement over scar tis- electronic equipment in the operating room,
sue, bony prominences or other areas where especially equipment that makes contact
pressure points on small areas might develop. with the patient. Adverse effects can only be
• Because of the risk of burns, needles should mitigated by use of equipment specifically
never be used as a dispersive electrode for designed to tolerate electrosurgical interfer-

1-
ence. Cables subject to flexing should be
with this equipment be read, understood and
inspected frequently for shielding integrity.
followed in order to ensure safe and effective
• Other equipment in the operating room, use of the equipment. Only properly quali-
including portable or mobile communica- fied and trained operators should perform
tions equipment, may produce EMI, which electrosurgery. The operator and their sup-
can affect the function of the ESU. Adverse port personnel must be diligent in assuring
effects can only be mitigated by use of that the ESU is properly configured and that
equip- ment with EMI characteristics proven proper settings are used. The ESU must be
below recognized limits. In the event of located to assure the operator or their support
suspected interference from other equipment, personnel can readily verify the settings.
discon- tinue use of the ESU until the
• PLEASE NOTE: Federal law (U.S.A.)
problem can be remedied.
requires that all health care facilities must
• The patient should not be allowed to come report to the manufacturer of a medical
into contact with metal items that are ground- device, any death or serious injury or illness
ed or have an appreciable capacitance to earth. to a patient related to the use of a medical
Examples of this would be operating tables, device. Serious injuries or illness involving
supports, etc. the use of a medical device must be reported
• Jewelry and other metallic items can cause to the manufacturer of the device (or to the
localized burns if they make contact with FDA if the manufacturer of the device is not
grounded items and should be removed from known) within 10 working days of the inci-
the patient prior to use of electrosurgery. dent. Summary reports of such injuries must
• Skin to skin contacts, such as between the arm also be submitted directly to the FDA twice
and body of a patient or between the legs a year. Patient deaths related to the use of a
and thighs, should be avoided by the medical device must be reported to the manu-
insertion of dry gauze. facturer and the FDA. For further informa-
tion, please contact the Regulatory Affairs
• The use of electrosurgery on patients with
Department of CONMED Electrosurgery at
cardiac pacemakers, AICDs, neurostimulators
800-552-0138, 303-699-7600 or FAX 303-
or other active implants is potentially hazard-
699-9854.
ous. The implant may be irreparably dam-
aged and/or the high frequency energy of the • Do not use monopolar electrosurgery on small
electrosurgical output may interfere with the appendages, as in circumcision or finger sur-
function of the implant. Ventricular fibrilla- gery, as it can cause thrombosis and other
tion may occur. Precautions should be taken unintended injury to tissue proximal to the
to ensure the patient’s well-being is main- surgical site. Should the surgeon decide that
tained in the event of such interaction. The the bipolar electrosurgical technique is accept-
manufacturers of the implants should be con- able for circumcision, do not apply the bipolar
sulted for advice before operating on a patient electrosurgical current directly to circumcision
with an implant. These precautions also apply clamps.
to operating room personnel with similar • Apparent low power output or failure of the
implants. electrosurgical equipment to provide the
• To minimize the possibility of cardiac pace- expected effect at otherwise normal settings
maker interference, place the dispersive may indicate faulty application of the disper-
elec- trode such that the electrosurgical sive electrode, failure of an electrical lead or
current path does not intersect the path of excessive accumulation of tissue on the active
the pace- maker or leads. electrode. Do not increase power output
before checking for obvious defects or misap-
1.1.3 Cautions For Use plication of the dispersive electrode. Check
• Safe and effective electrosurgery is dependent for effective contact of the dispersive electrode
not only on equipment design, but also on to the patient anytime the patient is moved
factors under the control of the operator. It after initial application of the dispersive elec-
is important that the instructions supplied trode.

1-
• Studies have shown that smoke generated dur-
• The output power selected should be as low
ing electrosurgical procedures may be harmful
as possible and activation times should be as
to surgical personnel. These studies recom-
short as possible for the intended purpose.
mend using a surgical mask and adequate ven-
tilation of the smoke using a surgical smoke • The clinical use of electrosurgery is intermit-
evacuator or other means. tent in nature. This ESU should not be acti-
vated continuously for extended periods of
• In the event that the system resets due to a
time.
power interruption or low voltage, check the
contact of the dispersive electrode prior to • When uncertain of the proper setting for the
resuming electrosurgery. power level in a given procedure, start with a
low setting and increase as required.
• If a dispersive electrode or A.R.M.™ alarm is
sounded intraoperatively, physically confirm • Confirm that Pulse Cut Mode is properly
proper dispersive electrode attachment to the selected prior to activation to ensure that
patient and confirm that the display falls with- improper application does not result in
in the set range. Smooth the dispersive elec- patient injury. Set the monopolar coag power
trode surface with hand to ensure electrode to 0 when using Pulse Cut to ensure that an
contact to patient skin. Replace the dispersive accidental activation of coag does not cause
electrode if necessary. patient injury. Listen for the distinct Pulse
Cut Activation Tone during activation to
• Simultaneous activation can be used in both
con- firm that Pulse Cut is indeed active.
Standard and Spray monopolar coagulation
modes. Caution should be used as the • Observe all caution and warning symbols
output from either active electrode may printed on the ESU.
change as a result of activation of a second • The operating room staff should never contact
output or end- ing activation of an output. electrosurgical electrodes (either active or dis-
Power sharing is unlikely to be equal because persive) while the RF output of the ESU is
of differences in electrode to tissue distance energized.
and other factors. • The electrodes of recently activated accesso-
This unequal power sharing can be enough ries may be hot enough to burn the
to stop power delivery to one electrode if patient or ignite surgical drapes or other
the flammable material.
second electrode is close to tissue and the first
• Do not ignore unexpected tones. Check to
electrode is somewhat above the tissue. The
determine the cause of the tone, otherwise
motion or deactivation of one electrode can
injury can occur.
cause the other electrode to start delivering
power when it had been too far away from • Temporarily unused active electrodes should
tissue to arc before the first electrode change. be stored in an electrically insulated holster.
Simultaneous activation can also increase The unused active electrode should never
leakage currents, which can be hazardous to be placed on the patient. This is especially
the patient. It is recommended that a second important for laparoscopic procedures.
electrosurgical generator be used when it is • Ensure that the footswitches are not inadver-
necessary to perform simultaneous operation. tently depressed in order to prevent acces-
• The cables to the surgical electrodes (active, sories from being unintentionally activated.
bipolar or dispersive electrodes) should be Place footswitches in locations that necessi-
positioned in such a way that contact with the tate deliberate action in order to activate the
patient or other leads is avoided. footswitch. Use caution when selecting the
correct footswitch to activate.
• Confirm the desired specialty mode is selected
prior to use to ensure output characteristics 1.1.4 Cautions For Testing or Servicing
are suitable for the intended procedure.
• Service should not be attempted without refer-
• Confirm the desired bipolar mode is selected ence to the System 5000™ service manual
prior to use to ensure output characteristics (Catalog Number 60-8017-ENG).
are suitable for the intended procedure.

1-
• This electrosurgical unit should be tested by
• Although this ESU will withstand momentary
a Hospital Qualified Biomedical Technician
short circuits on the output, prolonged short
on a periodic basis to ensure proper and safe
circuits may damage the ESU. Short-circuit-
operation. It is recommended that examina-
ing the output should be avoided since it is
tion of the ESU be performed at least
neither necessary nor desirable.
yearly.
• Since the clinical use of electrosurgical units
• Refer all servicing to a Hospital Qualified
is intermittent in nature with duty cycles on
Biomedical Technician. Your CONMED
the order of 10%, this ESU is not designed
sales representative will be happy to assist
to operate for extended periods of continu-
you in getting your equipment serviced.
ous output. When testing, it is recommended
• High voltages are developed within the ESU that duty cycles be limited to 10 seconds
that are accessible when the top cover is activation with delays of 30 seconds between
removed. These voltages are potentially dan- activations.
gerous and should be treated with extreme
• Activating the System 5000™ in other than its
caution.
normal operating position impairs the heat
• The high voltage DC power supply in the dissipation capability of the heat sink.
System 5000™ is equipped with a bleeder
• Ensure that the two top cover screws are
resistor to dissipate the charge on the filter
tight- ened and always perform a power-up
capacitor. However, it takes several seconds
check to confirm a normal power-up sequence
after power is removed to bleed that charge
before returning the ESU to service.
down to a safe level. It is recommended
that at least thirty (30) seconds be allowed • Improperly connecting test equipment can
to elapse before touching or attempting to cause electric shock and destruction of equip-
per- form any maintenance involving the ment.
power supply or power amplifier. • Turn unit off and wait until storage capacitors
• Never remove or install any parts with the have discharged before connecting test equip-
power cord connected to AC mains. ment.
• Avoid contact with the output leads when • Loss of power supply isolation can cause elec-
the ESU is activated. Periodically inspect trical shock. When servicing the high voltage
the test leads used for the output power supply, assume internal isolation is
connections for obvious defects. compromised until verified otherwise.

1.1.5 Electromagnetic Compatibility


Following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the
System 5000™.
1.1.5.1 EN/IEC 60601-1-2 Table 201

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions


The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 2 The System 5000 Electrosurgical Unit must emit electromagnetic
CISPR 11 energy in order to perform its intended function. Nearby elec-
tronic equipment may be affected.
RF emissions Class A The System 5000 Electrosurgical Unit is suitable for use in all
CISPR 11 establishments, other than domestic establishments and those
Harmonic emissions Class A directly connected to the public low-voltage power supply net-
IEC 61000-3-2 work that supplies buildings used for domestic purposes.
Voltage fluctuations/ Complies
Flicker emissions
IEC 61000-3-3

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1.1.5.7 EN/IEC 60601-1-2 Table
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.
Immunity Test IEC60601 test Compliance Electromagnetic environment -
level level guidance
Electromagnetic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
(ESD) tile. If floors are covered with synthetic mate-
±8 kV air ±8 kV air
rial, the relative humidity should be at least
IEC 61000-4-2
30%.
Electrical fast transient/ ±2 kV for power ±2 kV for power Mains power quality should be that of a
burst supply lines supply lines typi- cal commercial or hospital
environment.
IEC 61000-4-4 ±1 kV for ±1 kV for
input/ output input/ output
lines lines
Surge ±1 kV differential ±1 kV differential Mains power quality should be that of a
mode mode typi- cal commercial or hospital
IEC 61000-4-5
environment.
±2 kV ±2 kV
common mode common mode
Voltage dips, short inter- <5 % UT <5 % UT Mains power quality should be that of a typi-
ruptions and voltage (>95 % dip in UT) (>95 % dip in UT) cal commercial or hospital environment. If
variations on power sup- for 0.5 cycle for 0.5 cycle the user of the System 5000 Electrosurgical
ply input lines Unit requires continued operation during
40 % UT 40 % UT
power mains interruptions, it is recommended
IEC 61000-4-11 (60 % dip in UT) (60 % dip in UT)
that the System 5000 Electrosurgical Unit be
for 5 cycles for 5 cycles
powered from an uninterruptible power sup-
70 % UT 70 % UT ply or a battery.
(30 % dip in UT) (30 % dip in UT)
for 25 cycles for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should be at
Hz) magnetic field levels characteristic of a typical location in a
typical commercial or hospital environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

1-
1.1.5.3 EN/IEC 60601-1-2 Table 204

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


The System 5000™ Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 5000 Electrosurgical Unit should assure that it is used in such an environment.
Immunity Test IEC60601 test Compliance Electromagnetic environment - guidance
level level
Portable and mobile RF communications equipment
should be used no closer to any part of the System
5000™ Electrosurgical Unit, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d = 1.2√P


IEC 61000-4-6 150 kHz to 80 MHz

Radiated RF 3 V/m 3 V/m d = 1.2√P 80 MHz to 800 MHz


IEC 61000-4-3 80 MHz to 2.5 GHz

d = 2.3√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the


transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation dis-
tance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) tele-
phones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the System 5000™ Electrosurgical Unit is used exceeds the
applicable RF compliance level above, the System 5000™ Electrosurgical Unit should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the System 5000™ Electrosurgical Unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [v1] V/m.

1-
1.1.5.9 EN/IEC 60601-1-2 Table
Recommended separation distances between portable and mobile RF communications equipment
and the System 5000™ Electrosurgical Unit
The System 5000™ Electrosurgical Unit is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the System 5000™ Electrosurgical Unit can help prevent elec-
tromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip-
ment (transmitters) and the System 5000™ Electrosurgical Unit as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter (m)
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) d = 1.2√P d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

1.2 Specifications
Input Power: 600 watts maximum

Frequency Mains Voltage VRMS Mains Current ARMS


Fuses*
Hz Nominal Minimum Maximum Maximum
50-60 115 104 127 5.3 T6.3A
50-60 100 90 110 6.2 T8.0A
50-60 230 198 253 2.7 T3.15A

*Fuses are Type T, High Breaking


1.2.1 Mains Overcurrent Protection
Two fuses for each ESU with ratings as noted in the table above.
1.2.2 Mains Frequency Leakage
Designed to comply with IEC60601-1: 1995.
Patient connections to Neutral: Less than 10
µA.
Chassis to Neutral: Less than 25 µA (120V), Less than 45 µA (240V).

1-
1.2.3 Regulatory Compliance
Designed to comply with Medical Electrical Equipment Standards (UL2601-1: 2000, IEC60601-1:
1995, IEC60601-1-1: 2000, IEC60601-1-2: 2001, IEC60601-1-4: 2000, IEC60601-2-2: 1998,
ANSI/AAMI
HF18: 2001).
Manufactured in an ISO 13485: 2003 Registered
Facility. Type of protection against electric shock: IEC
Class 1.
Degree of protection against electric shock: Type CF, Defibrillator Proof.
Non-Ionizing Radiation.
1.2.4 Operation
Mode of operation: Intermittent 10 Sec on/30 Sec off.
1.2.5 Power Display Accuracy
The greater of ±10% of display or ±3 watts at rated load.
1.2.6 Line Regulation
Power Change <1%/V for the range of line voltages specified.
1.2.7 Environmental
Operating Conditions: 10°C to 30°C, 95% RH Non-condensing maximum.
Degree of protection against Ingress of Water: IPX1 (Protection against vertically falling water drops).
Mounting Restriction: 2-inch (5cm) clearance required on each side, back and above the ESU for cooling.
Cooling: Natural convection, conduction, radiation and temperature controlled fan.
Storage Conditions: -40°C to 70°C, at altitudes from –60 to +4500 meters above mean sea level when sealed
in original poly bag, packing material and shipping carton.
Prior to shipment or storage, the ESU should be enclosed and sealed in a polyethylene bag and placed in
original carton using original packaging materials.
RF Leakage: <100 mA per IEC60601-2-2: 1998, Clause 19.3.101b.
1.2.8 Contact Quality Monitor
Single dispersive electrode: Two wire continuity detector, typical trip threshold is 10 ohms
Dual dispersive electrode: Two wire resistance monitor, typical acceptance range 10 to 150 ohms, trip thresh-
old typically 30% higher than initial activation, visual indication of patient resistance changes.
1.2.9 Audio Specifications
Enter Cut Remote Power Control = 440 Hz fol-
Cut = 520 Hz lowed by 574 Hz
Coag = 440 Hz Enter Coag Remote Power Control = 440 Hz
Bipolar = 440 followed by 515 Hz
Hz Bipolar Output Tone = 215 Hz
Acc Fault = 847 Hz (pulsating) Pulse Cut Activation Tone = 520 Hz with peri-
Dispersive Electrode Alarm = 847 Hz (pulsating) odic short pulses at 481 Hz during output
Err Fault = 847 Hz (pulsating) power pulses
Increase Power Level = 379 Hz Pulse Coag Activation Tone = 440 Hz with peri-
odic short pulses at 384 Hz
Decrease Power Level = 343 Hz
(All tones are 45 dbA minimum except Alarms, which are 65 dbA minimum)

1-
1.2.10 Other Specifications
Power Cord: All units supplied with an IEC-320 250V 10A 65°C mains inlet connector. Power cords can
be ordered from CONMED Electrosurgery or obtained from other sources if the following specifications are
met:
Region Specification Description Standard
USA, Any UL, CSA SJT or better 250VAC, minimum 16AWG, 3 Conductor, maxi- UL817
Canada manufacturer mum length 20 feet (6m)
Europe Any HAR cord <HAR>H05WF3G1.0 Copper 1.0mm2 minimum cross sectional area, IEC60799
manufacturer maximum length 20 feet or 6.0m

Weight: 21.5 lb. (9.75 Kg)


Height: 5.5 inches (14 cm); Width: 13.5 inches (35 cm); Depth: 21.5 inches (48 cm) including handle
SPECIFICATIONS SUBJECT TO CHANGE WITHOUT NOTICE
1.2.11 Operating Modes and Nominal Output Parameters

Mode Max Rated Typical Max Open Max Carrier Pulse


Power Load Crest Circuit Loaded Freq. Repetition
(watts) (ohms) Factor Voltage Voltage (KHz)* Freq. (KHz)
(Peak) (Peak)
Monopolar
Pure Cut 300 500 1.4 - 1.7 800 820 391 N/A
Blend 1 200 500 1.5 – 1.9 860 930 391 20.0
Blend 2 200 500 1.8 – 2.4 1100 1100 391 20.0
Blend 3 200 500 2.4 – 2.9 1480 1480 391 20.0
Pinpoint Coag 120 500 3.7 - 4.6 2120 2120 391 20.0
Standard Coag 120 500 5.6 – 6.6 3140 3500 562 39.0
Spray Coag 80 500 7.1 – 9.7 6350 6350 562 19.5
Bipolar
Micro Coag 50 50 1.5 – 1.9 170 180 391 N/A
Macro Coag 90 300 1.6 - 2.0 610 610 391 N/A
*Measured in the open circuit condition.
•Activation of Pulse Cut will make the selected cut mode, Pure Cut, Blend 1, Blend 2, or Blend 3 active for
70 milliseconds every 600 milliseconds.
•Activation of Pulse Coag will make the selected coag mode, either Standard or Spray, active for 2.5 mil-
liseconds every 5 milliseconds. Displayed power setting will represent the average power being delivered
which is approximately half the power delivered during the pulses.
•LAP Specialty Mode output parameters match general operation parameters except the maximum voltage
is limited to less than 2700 Volts peak.
•FLUIDS Specialty Mode output parameters match general operation parameters with an initial energy
boost upon activation to initiate an arc.

1-
1.3 Explanation of Symbols
Remote Power Control Key:
1.3.1 Control Panel Press to enable or disable Remote
Power Control.
Note: International System 5000™ units use
symbols on the Control Panel. Some symbols are
replaced by words on the domestic (U.S.) units. Program
These words are indicated by bold text in the sym-
bol description.
Program Store Key
Pure Cut waveform with minimum
ther- mal damage and hemostasis.

Blend 1 waveform with moderate Selection Scroll Button


hemostasis.
1.3.2 Interior
Blend 2 waveform with medium
hemostasis.
Protective Earth (Inlet
Blend 3 waveform with maximum Connector)
hemostasis.

High Voltage Circuitry


Pinpoint Monopolar Coagulation.
1.3.3 Output/Control Panel
Standard Monopolar Coagulation. Dispersive Electrode –
Connection for monopolar dis-
persive electrode.
Spray Monopolar Coagulation.
ReadiPlug™ Universal Accessory
Micro Bipolar Coagulation
Receptacle

Macro Bipolar Coagulation Hand-controlled Monopolar


Output: Connection for hand-
General Setup controlled monopolar accessories.

Fluids Specialty Mode


Bipolar Output: Connection
for bipolar accessories.
Lap Specialty Mode

Single Dispersive electrode Caution: High voltage output.


Status/Alarm Indicator for single
monopolar dispersive electrodes. Type CF: Patient connections are iso-
lated from earth and resist the effects
Dual Dispersive electrode of defibrillator discharge.
Status/Alarm Indicator for dual
monopolar dispersive electrodes. RF Isolated: Patient connections are
isolated from earth at high frequency.
Bipolar Output
Current Indicator Consult accompanying documents
prior to placing equipment in service.
Pulse Mode

1-
Power on: connected to the mains.
Equipotential Ground Terminal.
Power off: disconnected from the
mains.
Replace fuse only with type and rat-
1.3.4 Rear Panel ing as shown.

Enclosure resists entry of vertically Caution - High Voltage Inside -


falling water. Refer servicing to qualified person-
nel.
Consult accompanying documents
prior to placing equipment in service. Serial Interface Connector.
This equipment intentionally supplies
Volume control: Bipolar Activation
non-ionizing RF energy for physi-
tone.
ological effect.

Explosion risk if used in the presence


of flammable anesthetics. Volume control: Activation tone.

Do not operate in oxygen


enriched environments.
Volume increase/decrease.

Bipolar Footswitch Connector. Medical Electrical Equipment:


With respect to electric shock, fire
Monopolar Footswitch
and mechanical hazards only in
Connector.
accordance with UL2601-1/CAN/
CSA C22.2 NO. 601.1 380X
Activation relay connector.

1-
1.4 Output Characteristic Curves
Figure 1.1 illustrates output power delivered to rated load for all available modes. Figure 1.2 illustrates the
maximum peak voltage available at a given power setting and output mode. Section 1.2 specifies rated loads
and maximum power for each mode, while figures 1.3 – 1.11 illustrate output power delivered to a range
of load resistances for each mode.
Power Output (Watts to Rated

Displayed Setting

Figure 1.1 Output Power vs. Power Setting

5000
4000
3000
Output Voltage

2000
1000
0
0 100 200 300
Power Setting

Figure 1.2 Display vs. Open Circuit Peak Voltage

1-
Output Power

Load Resistance (Ohms)

Figure 1.3 Load Regulation, Monopolar Pure Cut


Output Power

Load Resistance (Ohms)

Figure 1.4 Load Regulation, Monopolar Blend 1

1-
Output Power

Load Resistance (Ohms)

Figure 1.5 Load Regulation, Monopolar Blend 2


Output Power

Load Resistance (Ohms)

Figure 1.6 Load Regulation, Monopolar Blend 3

1-
Output Power

Load Resistance (Ohms)

Figure 1.7 Load Regulation, Monopolar Pinpoint Coag


Output Power

Load Resistance (Ohms)

Figure 1.8 Load Regulation, Monopolar Standard Coag

1-
Output Power

Load Resistance (Ohms)

Figure 1.9 Load Regulation, Monopolar Spray Coag


Output Power

Load Resistance (Ohms)

Figure 1.10 Load Regulation, Bipolar Micro

1-
Output Power

Load Resistance (Ohms)

Figure 1.11 Load Regulation, Bipolar Macro


Output Power

Load Resistance (Ohms)

Figure 1.12 Load Regulation, Lap Spray

1-
Output Power

Load Resistance (Ohms)

Figure 1.13 Load Regulation, Lap Standard

1-
TM

Installation and Operation


Section 2.0

This section contains initial installation, prelimi-


e) Re-insert the two FUSE RECEPTACLE
nary checks and operating instructions for the
covers, with fuses installed, into the FUSE
System 5000™.
RECEPTACLES.
2.1 Initial Inspection f) Use a flat blade screwdriver to gently push
Unpack the ESU upon receipt and physically each of the two covers into the FUSE
inspect it for any obvious damage that may have RECEPTACLES and rotate each one
occurred during shipment. A Hospital Qualified approxi- mately ¼ turn to the right to lock
Biomedical Technician should perform this inspec- them in place.
tion. Notify the carrier and your CONMED rep- g) Connect the power cord to the back of the
resentative immediately if damage is found. ESU. Installation of the ESU may now be
completed.
2.2 Installation
WARNING
The ESU may be mounted on a matching mobile THE POWER CORD OF THE ESU
pedestal or any stable mobile pedestal or table. SHOULD BE CONNECTED TO
2.2.1 Installation Of Fuses A PROPERLY POLARIZED AND
GROUNDED POWER SOURCE
Outside of the U.S., proper fuses must be installed WHOSE VOLTAGE AND
prior to connection to any power source. Install FREQUENCY
fuses in the following manner: CHARACTERISTICS ARE COMPATIBLE
a) Ensure the power cord is disconnected from WITH THOSE LISTED ON THE
the ESU. NAMEPLATE OF THIS ESU.
b) Locate the fuses that are packaged with the CAUTION: Since the ESU depends on both
ESU. There will be three sets of fuses pro- natural convection and forced air for cooling,
vided: it should not be installed in a cabinet or similar
• 8.0 A for installations with nominal enclosure. If mounted on a shelf or otherwise
mains voltages of 100 VRMS (Part near a wall, allow a two-inch clearance around and
num- ber 62-4236-800). above the ESU to permit free circulation of air
• 6.3 A for installations with nominal along the sides of the ESU.
mains voltages of 115 VRMS (Part num- 2.3 Preliminary Checks
ber 62-4236-630).
Prior to initial installation and use of this ESU,
• 3.15 A for installation with nominal
performance of the device should be tested in
mains voltages of 230 VRMS or
accordance with this manual. Results of that test-
greater (Part number 62-4236-315).
ing should be compared to the results tabulated
Choose the correct fuses for the mains voltage in on the factory Test Data Sheet supplied with each
the location where the ESU will be used. ESU. This data should be retained for future ref-
c) Use a flat blade screwdriver to remove erence and comparison.
the covers from each of the two FUSE
2.3.1 Preliminary Functional Testing
RECEPTACLES by turning the covers
approximately ¼ turn to the left. The following checks are recommended upon ini-
d) Insert one of the chosen fuses in each of the tial installation of the equipment and prior to each
two FUSE RECEPTACLE covers. use of the instrument to avoid unnecessary delays
in surgery. See Figure 2.1 for location of controls
and connectors.

2
1. Ensure the power switch is OFF and
• Pressing the Monopolar Cut Power
no accessories are connected.
Adjustment Keys to increase and decrease
2. Connect the power cable to a properly the setting while verifying that the display
grounded and polarized mating power recep- changes appropriately and verifying that
tacle of the proper voltage and frequency. no other displays change.
3. Connect a CONMED dual-treadle • Pressing the Cut Mode Scroll Key and
monopolar footswitch and a single treadle verifying that the settings for each of
CONMED bipolar footswitch to their mating the other modes were not changed by
connec- tors at the rear of the ESU. Note: chang- ing the Pure Cut Mode power
Use only CONMED Electrosurgery setting.
footswitches. Although other types may fit,
9. Verify that each of the other modes can be
they may not be functionally compatible.
selected and adjusted up and down in the
4. Make no connection to the dispersive elec- same manner as the Pure Cut Mode described
trode receptacle at this time. above. The other modes include:
5. Set the Power Switch to the ON (“|”) posi- • Blend 1
tion. As the ESU goes through the internal
• Blend 2
self-diagnostics, it should respond by:
• Blend 3
a) Sounding a series of test tones.
• Pinpoint Coag
b) During the test tone, displaying a total
of nine “8’s” on the four digital displays. • Standard Coag
c) Illuminating all three activation indica- • Spray Coag
tors, all eight key indicators, two disper- • Bipolar Micro
sive electrode indicators and the entire • Bipolar Macro
dual dispersive electrode contact quality
• Pulse Cut
BARGRAPH.
• Pulse Coag
d) After the display test, the ESU will
show the software revision level in the • FLUIDS Specialty Mode
COAG display window. The ESU is • LAP Specialty Mode
conducting a power-on self-test during Return all settings to the desired setting.
this interval.
10. Select each of the specialty modes by press-
e) If there are no errors, normal operational ing the Specialty Mode Scroll Key and
parameters will then be displayed. verify- ing that the selected specialty mode
6. Depress the Cut treadle of the monopolar scrolls through General, Fluids, and Lap.
footswitch. The dispersive electrode alarm Verify that the displayed power settings for
should sound and dispersive electrode indica- each specialty mode can be changed
tors should flash alternating red. While hold- independently
ing the Cut treadle, rotate the volume of the other modes by adjusting the cut,
control over its full range and verify there is coag, or bipolar power. Return all settings to
no sig- nificant change in sound level. the desired setting and return the specialty
Release the Cut footswitch and the tone mode to General before proceeding.
should stop. 11.Depress the bipolar footswitch. Confirm that
7. Select each of the modes by pressing the the Bipolar Activation indicator illumi- nates
Mode Scroll Keys and note the displayed and a bipolar activation tone is sounded.
power settings for each mode in the corre- While continuing to depress the bipolar
sponding displays. footswitch, rotate the Volume Control over
8. Verify that the Pure Cut Mode can be its full range to verify the function of that
selected and adjusted up and down by: control and that sound is audible at all posi-
• Pressing the Cut Mode Scroll Key until tions. This control may be left at any desired
the Pure Cut Activation indicator is illu- position. Release the bipolar footswitch and
minated. confirm the System 5000™ returns to its idle
state. Set the bipolar power setting to 1 watt
and verify the bipolar hand control is func-

2-
tional by use of the appropriate forceps or
the best accuracy of the tester. (See Specifications,
by connecting a jumper between the center
Section 1.2).
and right hand Bipolar Output receptacle on
the Output Panel. The effect will be If no tester is convenient, the availability of thera-
identical to depressing the bipolar peutic current may be ascertained subjectively by
footswitch. attempting to cut and coagulate on surrogate tis-
sue such as a piece of meat or fresh fruit, a wet
12. Verify that the Single and Dual Dispersive
bar of soap or a sponge moistened with saline.
Electrode Status / Alarm Indicators alternately
flash red. Connect a single dispersive elec- 2.4 Controls, Displays and Connectors
trode to the Dispersive Electrode Receptacle.
Confirm the Single Dispersive Electrode The numbers preceding the following paragraphs
Status / Alarm Indicator is steady green. correspond to the numbered items in Figures 2.1,
2.2 and 2.3.
13. Depress the Cut treadle of the Monopolar
footswitch. The yellow Cut Activation indica- 2.4.1 Control Panel
tor should light and the cut activation tone All controls, except for the volume controls, are
should sound. located on the front control panel. Figure 2.1
14. While continuing to press the Cut treadle illustrates the Universal Symbols control panel.
of the footswitch, press the Coag treadle. Your control panel may be in English.
The yellow Cut Activation indicator should 1. DUAL DISPERSIVE ELECTRODE
remain illuminated and the Cut activation STATUS / ALARM INDICATOR: Indicates
tones should continue. Release the Cut the status of a dual dispersive electrode when
treadle while continuing to press the Coag the dual dispersive electrode is connected
treadle and confirm that the yellow Cut to the ESU. This indicator is made up of a
Activation indicator extinguishes, the blue STATUS INDICATOR and a BARGRAPH,
Coag Activation indicator illuminates and which indicates the relative quality of the dual
the activation tone changes from Cut to dispersive electrode application.
Coag. Release the coag treadle and verify
that the display returns to normal. Press the The STATUS INDICATOR will flash red
Coag treadle and verify that the blue Coag prior to connection of any dispersive electrode
Activation indicator illuminates until the Coag or connection of a dual dispersive electrode
treadle is released. that is not applied to the patient. This indi-
cator will flash green after a dual dispersive
15. Connect a hand-controlled accessory to one electrode is applied to the patient and the
of the Monopolar Accessory Receptacles. contact quality of the dual dispersive electrode
Activate the Cut and Coag buttons on the is at an acceptable level. The status indicator
accessory, one at a time, verifying that each will illuminate steady green upon first activa-
control causes the correct indicator and tone tion using a hand control or footswitch with
to sound. Move the hand-controlled acces- a dual dispersive electrode that is installed and
sory to the other Monopolar Accessory connected with acceptable contact quality.
Receptacle and repeat.
Prior to activation, the BARGRAPH will
16. Disconnect the single dispersive elec- show a relative measure of the contact qual-
trode and confirm that the System 5000™ ity between the two elements of the dual
beeps three times and the Single and Dual dispersive electrode. Good contact quality is
Dispersive Electrode Status / Alarm Indicators indicated by illumination of many segments,
alternately flash red. while poor contact quality will illuminate
2.3.2 Preliminary Performance Testing fewer segments. Acceptable contact quality to
enable safe use of the ESU will be indicated
After the ESU passes the Preliminary Functional by illumination of one or more segments.
Tests of Section 2.3.1, preliminary performance All of the BARGRAPH segments will be
testing may be conducted. Such testing is best illuminated upon activation with an accept-
carried out by use of an electrosurgical generator ably installed and connected dispersive elec-
tester. Use a non-inductive resistor with the same trode. Fewer segments of the bar graph
value as the rated generator output impedance for will

2-
be illuminated as the contact quality of the
If the quality of connection between the ESU
dispersive electrode deteriorates; as a result,
and the single dispersive electrode deteriorates
the Dual Dispersive Electrode Status / Alarm
to a level that is unacceptable, this STATUS
Indicator gives a relative measure of contact
INDICATOR will flash red and an alarm will
quality as the procedure progresses.
sound.
If the contact quality deteriorates to a level
3. GENERAL MODE INDICATOR: This
that is unacceptable, all BARGRAPH seg-
default mode illuminates when no Specialty
ments will be extinguished, the STATUS
modes are selected.
INDICATOR will flash red and an alarm will
sound. 4. FLUIDS SPECIALTY MODE
INDICATOR: Illuminates when Fluids
2. SINGLE DISPERSIVE ELECTRODE
Specialty Mode is selected.
STATUS / ALARM INDICATOR: Indicates
the status of a single dispersive electrode when 5. LAP SPECIALTY MODE INDICATOR:
the single dispersive electrode is connected to Illuminates when Lap Specialty Mode is
the ESU. This STATUS INDICATOR will selected
flash red prior to connection of any dispersive 6. PROGRAM INDICATOR: Indicates the
electrode. This STATUS INDICATOR will selected program.
illuminate steady green after a single disper- 7. SPECIALTY MODE SCROLL KEY:
sive electrode is acceptably connected to the Pressing this key will scroll between General
ESU. mode, Fluids mode and Lap mode.
WARNING 8. PROGRAM SELECT SCROLL KEY:
THE SINGLE DISPERSIVE ELECTRODE Pressing this key will scroll between the stored
STATUS / ALARM INDICATOR DOES program locations.
NOT PROVIDE ANY INDICATION OF 9. PROGRAM STORE KEY: Stores the current
THE CONTACT QUALITY BETWEEN settings into the selected program location.
THE SINGLE DISPERSIVE ELECTRODE 10. PURE CUT ACTIVATION INDICATOR:
AND THE PATIENT. Illuminates when monopolar Pure Cut Mode
has been selected.

10. PURE CUT MODE 16. MONOPOLAR CUT 20. PINPOINT COAG
INDICATOR ACTIVATION INDICATOR INDICATOR
11. BLEND 1
INDICATOR 15. MONOPOLAR CUT 21. STANDARD COAG
POWER DIGITAL DISPLAY INDICATOR
12. BLEND 2
INDICATOR 22. SPRAY COAG
14. PULSE CUT INDICATOR 24. MONOPOLAR COAG
13. BLEND 3 INDICATOR POWER DIGITAL DISPLAY
INDICATOR
1. DUAL DISPERSIVE ELECTRODE 25. MONOPOLAR COAG 29. MICRO BIPOLAR
23. PULSE COAG ACTIVATION INDICATOR INDICATOR
STATUS/ALARM INDICATOR INDICATOR
2. SINGLE DISPERSIVE ELECTRODE 30. MACRO BIPOLAR
STATUS/ALARM INDICATOR INDICATOR
31. BIPOLAR ACTIVATION
INDICATOR

32. BIPOLAR OUTPUT


3. GENERAL MODE CUT COAG BIPOLAR METER
INDICATOR

33. BIPOLAR POWER


DIGITAL DISPLAY
4. FLUIDS SPECIALTY
MODE INDICATOR

5. LAP SPECIALTY
MODE INDICATOR

6. PROGRAM
INDICATOR
7. SPECIALTY MODE
SCROLL KEY

SYSTEM 5000
8. PROGRAM SELECT TM
SCROLL KEY

9. PROGRAM
STORE KEY
35. BIPOLAR POWER
17. CUT MODE ADJUSTMENT KEYS
SCROLL KEY
34. BIPOLAR SCROLL KEY
18. MONOPOLAR CUT
POWER ADJUSTMENT KEYS
19. PULSE CUT KEY 28. PULSE COAG KEY
27. MONOPOLAR COAG
POWER ADJUSTMENT KEYS
36. REMOTE POWER
CONTROL KEY 26. COAG SCROLL KEY

Figure 2.1 Control Panel

2
11.BLEND 1 INDICATOR: Illuminates when
28. PULSE COAG KEY: Pressing this key will
monopolar Blend 1 is selected.
select or deselect Pulse Coag.
12. BLEND 2 INDICATOR: Illuminates when
29. MICRO BIPOLAR INDICATOR:
monopolar Blend 2 is selected.
Illuminates when micro bipolar is selected.
13. BLEND 3 INDICATOR: Illuminates when
30. MACRO BIPOLAR INDICATOR:
monopolar Blend 3 is selected.
Illuminates when Macro Bipolar is selected.
14. PULSE CUT INDICATOR: Illuminates
31. BIPOLAR ACTIVATION INDICATOR:
when Pulse Cut is selected.
This indicator lights when the ESU is activated
15. MONOPOLAR CUT POWER DIGITAL in the bipolar mode.
DISPLAY: Indicates the power setting for
32. BIPOLAR OUTPUT METER: This bar
the currently selected monopolar cut mode.
graph display provides a measure of the tissue
16. MONOPOLAR CUT ACTIVATION resistance.
INDICATOR: This yellow indicator lights
33. BIPOLAR POWER DIGITAL DISPLAY:
when the ESU is activated in a monopolar
Indicates the bipolar mode power level set via
cut mode.
the Bipolar Power Adjustment Keys.
17. CUT MODE SCROLL KEY: Pressing this
34. BIPOLAR SCROLL KEY: Pressing this key
key will scroll through the Cut Modes:
will scroll through the Bipolar Modes: Macro
Pure, Blend 1, Blend 2 and Blend 3.
and Micro.
18. MONOPOLAR CUT POWER
35. BIPOLAR POWER ADJUSTMENT
ADJUSTMENT KEYS: Adjusts the output
KEYS: Adjusts the output power level of
power setting of the selected cut mode.
the selected bipolar mode.
19. PULSE CUT KEY: Pressing this key will
36. REMOTE POWER CONTROL KEY:
select or deselect Pulse Cut.
Pressing this key will select or deselect
20. PINPOINT COAG INDICATOR: Remote Power Control. REMOTE POWER
Illuminates when monopolar Pinpoint coagu- CONTROL INDICATOR: Illuminates when
lation has been selected. Remote Power Control is selected.
21. STANDARD COAG INDICATOR:
2.4.2 Output Panel
Illuminates when monopolar Standard coagu-
lation has been selected. The output panel contains the power switch and
22. SPRAY COAG INDICATOR: Illuminates the accessory receptacles. The receptacles are illu-
when monopolar Spray coagulation has been minated to aid in the insertion of the connectors
selected. in low light conditions. Refer to Figure 2.2.
23. PULSE COAG INDICATOR: Illuminates 37. DISPERSIVE ELECTRODE
when Pulse Coag is selected. RECEPTACLE: This receptacle accepts
a standard two-pin single or dual
24. MONOPOLAR COAG POWER DIGITAL
dispersive electrode plug.
DISPLAY: Indicates the power setting in the
currently selected monopolar coagulation 38. ReadiPlug™ UNIVERSAL ACCESSORY
mode. RECEPTACLE: This receptacle accepts
acces- sory cables equipped with standard
25. MONOPOLAR COAG ACTIVATION
active (Bovie #12) plugs, standard 4mm
INDICATOR: This blue indicator lights
banana plugs or pin-tip style disposable
when the ESU is activated in a
connectors without the necessity of special
monopolar coagulation mode.
adapters.
26. COAG SCROLL KEY: Pressing this key
• Banana plugs can be inserted and removed
will scroll through the Coag Modes:
directly without pushing the button.
Pinpoint, Standard and Spray.
• To insert a Bovie #12 plug, you must
27. MONOPOLAR COAG POWER
push the button adjacent to the recep-
ADJUSTMENT KEYS: Adjusts the output
tacle, insert the plug fully and release the
power setting of the selected coagulation
button. IMPORTANT: When removing
mode.
a Bovie #12 plug, you must press the
button while pulling the plug out.

2-
37. TWO-PIN DISPERSIVE 39. HAND CONTROLLED MONOPOLAR
ELECTRODE RECEPTACLE ACCESSORY RECEPTACLES 41. POWER SWITCH

TM
38. ReadiPlug UNIVERSAL 40. BIPOLAR ACCESSORY
ACCESSORY RECEPTACLE RECEPTACLE

Figure 2.2 Output Panel

• When handling the pin-tip style plug, hold


2.4.3 Rear Panel
the wire about 3 inches (7.6 cm) from
the tip and push the button while insert- The rear panel contains the footswitch connectors,
ing the tip. IMPORTANT: Verify proper power cord connector, fuses, volume controls and
insertion by tugging gently on the plug a carrying handle. Refer to Figure 2.3.
to ensure that the ReadiPlug™ 42. CARRYING HANDLE
mechanism has properly retained the tip.
43. SPEAKER: Sound from the speaker
To remove the pin-tip, you must press the
ema- nates from this location.
button while pulling the plug out.
44. NAMEPLATE: Specifies model number,
• This receptacle can only be activated by
serial number, nominal line voltages, frequen-
the monopolar footswitch.
cy, current and fuse rating information.
WARNING
45. FAN: Forced air from the temperature-con-
NEVER CONNECT MORE THAN ONE trolled fan is expelled in this location.
ACCESSORY AT A TIME TO THIS
46. BIPOLAR FOOTSWITCH
RECEPTACLE.
CONNECTOR: A 3-pin threaded con-
39. HAND-CONTROLLED MONOPOLAR nector designed to accept any
ACCESSORY RECEPTACLE: Two inde- CONMED Electrosurgery single-treadle
pendent receptacles are provided for the con- bipolar footswitch.
nection of hand-controlled monopolar acces-
47. MONOPOLAR FOOTSWITCH
sories. Only by the accessories connected to
CONNECTOR: This 4-pin threaded con-
them may activate these receptacles.
nector is designed to accept plugs attached
40. BIPOLAR ACCESSORY RECEPTACLE: to any dual treadle monopolar footswitch
Bipolar output is activated by the bipolar available from CONMED Electrosurgery. Use
foot-controlled or by hand-controlled bipolar only CONMED Electrosurgery footswitches.
accessories. CONMED accessories with fixed Other manufacturer’s footswitches may not be
connection style plugs are recommended for compatible.
this receptacle. For legacy connections with
48. ACTIVATION RELAY CONNECTOR: A
two banana plug leads, connect these active
receptacle for actuating smoke evacuators and
bipolar forceps leads to the outside connec-
similar devices when delivering electrosurgical
tions.
output. The maximum contact rating for this
41. POWER SWITCH: Primary power switch receptacle is 1 amp at 24 volts DC. Verify
for turning the ESU on and off. that devices connected to this output func-
tion properly in a manner that is synchronized
with ESU power delivery prior to use.

2
42. CARRYING HANDLE 43. SPEAKER 44. NAMEPLATE 45. FAN

HOSPITAL
GRADE
ONLY

25V/1A
MAX

IOIOI

46. BIPOLAR 47. MONOPOLAR 48. ACTIVATION 49. FUSE


FOOTSWITCH FOOTSWITCH RELAY CONNECTOR RECEPTACLES 51. POWER INLET 53. BIPOLAR CURRENT 54. VOLUME
VOLUME CONTROL CONTROL
CONNECTOR CONNECTOR 50. EQUIPOTENTIAL
GROUND CONNECTION 52. SERIAL INTERFACE
CONNECTOR

Figure 2.3 Rear Panel

49. FUSE RECEPTACLES: For installation


increases the volume. It does not affect the
of two mains fuses with ratings as noted in
volume of alarm tones.
Section 2.2.1.
50. EQUIPOTENTIAL GROUND 2.5 Set Up For Use
CONNECTION: Chassis ground connection 1. Ensure the Power Switch is OFF, and then
suitable for attachment of standard auxiliary connect the power cable to a properly
grounding cable when required for additional grounded and polarized mating power recep-
protection against low frequency risk current. tacle. Do not connect a dispersive electrode
51. POWER INLET: Supplies AC mains power at this time.
to the ESU. It should only be connected to a 2. Inspect and connect the desired monopolar or
source of power corresponding to that listed bipolar accessories to the connectors on the
on the nameplate. front of the ESU. Refer to Figure 2.2.
52. SERIAL INTERFACE CONNECTOR: WARNING
This connector provides a means of connec-
tion with operating room control centers. ALWAYS STOW UNUSED
Only equipment approved by CONMED ACCESSORIES IN A SAFE, INSULATED
should be connected to this interface. LOCATION SUCH AS A HOLSTER. DO
Contact your CONMED Sales NOT
Representative or CONMED Customer PLACE ACTIVE ACCESSORIES ON THE
Service at the num- bers listed on the inside PATIENT.
front cover of this manual. 3. Connect the footswitches, as required, to the
53. BIPOLAR VOLUME CONTROL: rear of the ESU (not required if only hand-
Controls the volume of the special tones pro- controlled accessories are to be used). Use
duced during bipolar electrosurgery. Rotation only CONMED Electrosurgery
to the right increases the volume. Does not footswitches.
affect volume of alarm tones. 4. Set the Power Switch to the ON position. As
54. VOLUME CONTROL: Controls the vol- the ESU goes through its internal self-diag-
ume of the tones produced during normal nostics, confirm the machine responds by:
activation of the ESU. Rotation to the right a) Sounding a test tone.
b) During the test tone, displaying a total
of nine “8’s” on the four digital displays.

2-
c) Illuminating all three activation indica-
the dispersive electrode have not been satisfied
tors, all eight key indicators, two disper-
(see instruction 8).
sive electrode indicators and the entire
dual dispersive electrode contact quality 8. The A.R.M.™ dispersive electrode contact
BARGRAPH. quality monitor can automatically detect and
accept either single dispersive electrodes or
d) After the display test, the ESU will
dual dispersive electrodes.
show the software revision level in the
COAG display window. The ESU is The Single Dispersive Electrode Status /
conducting a power-on self-test during Alarm Indicator indicates the status of a single
this interval. dispersive electrode when the single disper-
sive electrode is connected to the ESU. This
After the power-on self-tests, the ESU is ready
STATUS INDICATOR will flash red prior to
for use. If the ESU sounds a pulsating high
connection of any dispersive electrode. This
tone, displays an “Err” fault code or otherwise
STATUS INDICATOR will illuminate steady
fails to respond as above, the ESU has failed
green after a single dispersive electrode is
one of its internal tests and is not suitable for
acceptably connected to the ESU. The Single
use. Before turning the power off, note the
Dispersive Electrode Status / Alarm Indicator
“Err” code displayed in the Power Displays
DOES NOT provide any indication of the
to assist in the diagnosis by a Hospital
contact quality between the single dispersive
Qualified Biomedical Technician. ACC
electrode and the patient.
codes can often be corrected by operating
room staff, see Section 2.7.2. Contact your If the connection between the ESU and
Hospital Qualified Biomedical Technician for the single dispersive electrode is broken,
repair if an “Err” code appears. the Single Dispersive Electrode
STATUS
5. When using monopolar modes, select and
INDICATOR will flash red and an alarm
prepare the patient dispersive electrode site
will sound.
and apply the dispersive electrode in full
contact with the patient and in accordance The DUAL DISPERSIVE ELECTRODE
with the manufacturer’s instructions. If no STATUS / ALARM INDICATOR indicates
instructions are given, observe the guidelines the status of a dual dispersive electrode when
provided in Section 1.0 of this manual. A the dual dispersive electrode is connected
dispersive electrode need not be connected if to the ESU. This indicator is made up of a
only BIPOLAR operation is required. BARGRAPH, which indicates the relative
quality of the dual dispersive electrode appli-
Caution: The use and proper placement of a
cation and a STATUS INDICATOR.
dispersive electrode is a key element in safe and
effective electrosurgery. Follow manufacturer’s The STATUS INDICATOR will flash red
directions and recommended practices for the prior to connection of any dispersive elec-
preparation, placement, use, surveillance and trode or connection of a dual dispersive elec-
removal of any dispersive electrode supplied trode that is not applied to the patient. This
for use with this electrosurgical unit. STATUS INDICATOR will flash green after
a dual dispersive electrode is applied and the
6. Apply the dispersive electrode over a well-vas- measured impedance between the dual disper-
cularized muscle mass that is thoroughly clean sive electrodes is at an acceptable level. The
and dry. Clean and clip site, as necessary, to STATUS INDICATOR will illuminate steady
provide adequate electrical connection and per green upon first activation using a hand
hospital policy. Avoid placement over scar tis- control or footswitch with a dual dispersive
sue, bony prominences or other areas where electrode that is installed and connected with
pressure points on small areas might develop. acceptable contact quality.
7. Inspect and connect the plug of the dispersive Prior to activation, the BARGRAPH will
electrode cable to the Dispersive Electrode show a relative measure of the contact qual-
Receptacle or to an appropriate adapter. ity between the two elements of the dual
NOTE: This ESU incorporates A.R.M.™ dispersive electrode. Good contact quality is
circuitry. The monitor will inhibit monopolar indicated by illumination of many segments,
operation of the ESU if its requirements for while poor contact quality will illuminate

2
fewer segments. Acceptable contact quality to
12. Set the Monopolar Cut Mode to Pure
enable safe use of the ESU will be indicated
for cutting or one of three Blend modes
by illumination of one or more segments. All
for desired cutting with hemostasis.
of the BARGRAPH segments will be illu-
minated upon activation with an acceptably 13. Set the Monopolar Coag Mode to
installed and connected dispersive electrode. PINPOINT to provide soft / low voltage con-
Fewer segments of the BARGRAPH will tact coagulation, to STANDARD to provide
be illuminated as the contact quality of the a greater degree of contact desiccation (i.e.
dispersive electrode deteriorates; as a greater arcing) or to SPRAY for non-contact
result, fulguration.
the Dual Dispersive Electrode Status / Alarm 14. Scroll to BIPOLAR MACRO for nor-
Indicator gives a relative measure of contact mal bipolar tissue desiccation or scroll to
quality as the procedure progresses. BIPOLAR MICRO for delicate bipolar tissue
If the contact quality deteriorates to a desiccation with low voltage.
level that is unacceptable, all 15. The Bipolar Output Meter provides a mea-
BARGRAPH segments will be sure of tissue desiccation between the bipolar
extinguished, the Dual forceps tines by measuring tissue resistance.
Dispersive Electrode Status / Alarm Indicator Higher tissue resistances indicate a greater
will flash red and an alarm will sound. degree of desiccation. Several illuminated
When alarm occurs, physically confirm segments indicates low desiccation, while
proper dispersive electrode-to-patient contact. fewer illuminated segments indicates higher
Smooth the dispersive electrode surface with desiccation. Few segments will be illumi-
hand to improve electrode contact to patient’s nated when bipolar power is first applied
skin. Green bar graph segments will indicate because the resistance of the tissue is high. As
improved patient contact. Replace the dis- bipolar power continues, inter cellular fluid
persive electrode if dispersive electrode is released, which decreases the resistance
status/ alarm indicator continues to flash causing more segments to illuminate. As
red. the tissue between the bipolar tines becomes
more desiccated, fewer elements of the bar
WARNING
graph will be illuminated. When the desic-
DO NOT DEPEND SOLELY ON THE cation reaches a point where one element
DUAL DISPERSIVE ELECTRODE of the bar graph is illuminated, the Bipolar
STATUS / ALARM INDICATOR FOR Output Tone will sound. Note: Depending
CONFIRMATION OF GOOD DISPERSIVE on the volume of tissue between the tines, the
ELECTRODE APPLICATION. Bipolar Output Meter movement could occur
QUALIFIED PERSONNEL SHOULD quite rapidly. Ensure that the tone volume is
MAKE THE FINAL DECISION ON properly set prior to using the Bipolar
PROPER DISPERSIVE ELECTRODE Output Tone feature. Bipolar Output Tone
PLACEMENT. volume can be set while activating in Bipolar
9. The ESU powers up to the last settings at mode with forceps open.
the time the ESU was last activated. Note: 16. Select Pulse Cut for pulsing bursts of
Power up to “0” setting is a configuration cut energy for precise dissection with
option that may be selected by a Hospital minimal thermal necrosis.
Qualified Biomedical Technician. Verify that 17. Select Pulse Coag for pulsing bursts of
the ESU is properly adjusted with the desired coagulation energy for precise hemostasis
mode selected. Adjust the settings as needed. in STANDARD or SPRAY modes. Pulse
The ESU is now ready for operation. Coag cannot be selected while PINPOINT is
10. Scroll to the LAP Specialty Mode to selected.
limit output voltage during Laparoscopic 18. Adjust the CUT, COAG, and BIPOLAR
proce- dures. power settings to the desired levels in the fol-
11.Scroll to the FLUIDS Specialty Mode to lowing manner:
initiate cutting and coagulating during proce-
dures conducted in fluid mediums.

2-
- To increment or decrement the power
The surgical effects obtained are dependent on a
setting one step, momentarily press and
release the desired CUT, COAG, or number of factors including waveform, electrode
BIPOLAR Power Adjustment Key. The size, electrode geometry, power level and surgical
power setting will increase one step and a technique. The size and geometry of monopolar
short tone will sound. electrodes are significant in that a large electrode,
absent of sharp features (e.g.; a ball electrode) will
- To increase or decrease the power set-
have no tendency to cut, regardless of the output
ting a number of steps, press and hold
power level. Conversely, a small, sharp electrode,
the desired CUT, COAG, or BIPOLAR
such as a needle or wire loop, will be likely to cut
Power Adjustment Key. For the first nine
simply from mechanical pressure at conservative
steps while the key is held, the power
power settings. Note that other generator models
setting will increase or decrease in step
will have different clinical effects than the System
increments with a short tone for each
5000™, even when power settings are the same.
step. If the key is continuously held
after the ninth step, power setting will The Bipolar Coagulation waveform is designed to
increase or decrease at an accelerated minimize tissue sticking and popping by limiting
rate, with a continuous tone, until the the output voltage regardless of the power set-
Power Adjustment Key is released. ting. Bipolar hemostasis is more localized than in
If unsure of the proper settings, use low monopolar since the tissue grasped between the
power settings initially and make adjustments forceps tines is most affected. This is particularly
intraoperatively according to the surgeon’s desirable in vascular surgery where monopolar
requests. Use of a written record of each current may concentrate in the affected vessel
surgeon’s preferred power setting for various and result in undesired tissue effects. This easily
procedures will expedite subsequent pre-op controlled localization is also of benefit in plastic
setup. surgery and neurosurgery.
2.6 Operation 2.6.2 Monopolar Pulse Cut
2.6.1 General Monopolar Pulse Cut provides pulsing bursts of
cut energy for precise dissection.
WARNING
In Monopolar Pulse Cut, Dissection will occur in
ENSURE THAT THE FOOTSWITCHES 70 ms durations every 600 ms. Each pulse will
ARE NOT INADVERTENTLY typically dissect less than 1 mm depending on the
DEPRESSED IN ORDER TO PREVENT power setting, the electrode size and type, and the
ACCESSORIES FROM BEING mass of the tissue being dissected. Two distinct
UNINTENTIONALLY ACTIVATED. tones are audible during activation in Pulse Cut as
PLACE FOOTSWITCHES described in Section 1.2.9. The power displayed
IN LOCATIONS THAT NECESSITATE on the dial is the power output during the
DELIBERATE ACTION IN ORDER TO pulses. While the pulsed nature makes the
ACTIVATE THE FOOTSWITCH. USE average power low, the power during pulses can
CAUTION WHEN SELECTING THE COR- be quite high.
RECT FOOTSWITCH TO ACTIVATE. WARNING
Activate the electrosurgical unit in the desired COAG ACTIVATIONS WILL NOT BE
operating mode by depressing the appropriate
PULSED WITH PULSE CUT SELECTED.
treadle of the footswitch or switch of a hand-
SET THE MONOPOLAR COAG POWER
controlled accessory. Adjust the corresponding
TO 0 WHEN USING PULSE CUT TO
power setting until the desired surgical effects are
ENSURE THAT AN ACCIDENTAL ACTI-
obtained.
VATION OF COAG DOES NOT CAUSE
Power setting changes are limited when the PATIENT INJURY.
ESU is activated to the greater of 10 watts or
WARNING
25% of the dial setting upon initiation of
activation. The power setting will be displayed on CONFIRM THAT THE PULSE CUT
the digital dis- play for each mode. MODE IS PROPERLY SELECTED
PRIOR TO ACTIVATION TO ENSURE
THAT IMPROPER APPLICATION DOES

2
NOT

2-
RESULT IN PATIENT INJURY. LISTEN
The unit automatically stores the most recent set-
FOR THE DISTINCT PULSE CUT
tings when powering down and will restore those
ACTIVATION TONE DURING
settings when the unit is turned ON. An “L” (for
ACTIVA- TION TO CONFIRM PULSE
Last) will be displayed in the Program Location
CUT IS INDEED ACTIVE. Indicator. Note that if a power loss occurs dur-
2.6.3 Monopolar Pulse Coag ing activation, the values stored in the “L” location
will be those just prior to the loss of power.
Monopolar Pulse Coag provides pulsing bursts
of coagulation energy for precise hemostasis in The “0” (zero) location sets all power settings
STANDARD or SPRAY modes. Average power to zero, and the activation modes to Pure Cut,
will be displayed as half of peak power for this Standard Coag and Bipolar Micro. The settings
selection. 1-9 contain user-stored settings.
Coagulation energy is pulsed on for 2.5 ms every 2.6.6.1 Storing Programs
5 ms providing higher peak power (during the 1. Select the desired storage location BEFORE
“on” portion) with an effective lower average setting the desired modes and power settings.
power resulting in reduced carbonization. Verify As each location is shown, the displays will
the Pulse Coag indicator is illuminated prior to indicate the contents of that location.
activation to ensure the proper setting. Listen for
the distinct Pulse Coag Activation tone during 2. Set the modes, power and pad settings as
activation to confirm Pulse Coag is indeed active. desired. Note that non-displayed mode set-
tings are also stored at this time.
2.6.4 Fluids Specialty Mode 3. Press the STORE key. If a correction is
FLUIDS Specialty Mode provides rapid initiation needed, simply set the machine as desired and
of clinical effect for surgical procedures conducted press STORE again. Confirm the program
in fluid mediums by providing an initial energy settings are correct before use.
burst when activation is initiated. 2.6.6.2 Using Programs
2.6.5 Lap Specialty Mode Select the stored setting location by scrolling
Lap Specialty Mode provides optimal safety by through the program locations using the Program
limiting output voltage, which minimizes the Select Scroll key. Confirm the program settings
potentially harmful effects of capacitive coupling are correct before use.
and insulation failure. Users will notice that 2.6.7 Remote Power Control
Standard Coag and Spray Coag will have a gen-
tler coagulation effect, that is, shorter arcs and a Remote Power Control provides the surgeon
smaller clinically-affected area when Lap Specialty with the ability to change power settings from
Mode is selected. When a more aggressive coagu- the surgical field using the activation switches on
lation effect is desired, Pinpoint Coag, Standard the monopolar accessory.
Coag or Spray Coag in the General Mode can be CAUTION: The Remote Power Control fea-
selected. When selecting General Mode from Lap ture should be enabled only if the surgeon
Specialty Mode, expect a more aggressive surgi- is familiar with its operation and requires its
cal effect and adjust power accordingly. Always capabilities. The power displays should be
use the lowest power setting necessary to get the monitored for expected effect while Remote
desired clinical effect. Refer to the instructions Power Control adjustments are being per-
provided by the manufacturer of the laparoscopic formed until normal operation is restored.
accessory concerning maximum voltage specifica-
The Remote Power Control may only be
tions.
activated when the Remote Power Control
2.6.6 Programming Indicator is on.
This mode may be selected or deselected with
Up to 9 complete mode and power settings
the Remote Power Control Key. Remote
can be easily stored and recalled at any time.
Power Control will always be disabled after
Additionally, there are two settings that the unit
power up.
automatically sets, “L” and “0” (zero).

2
2.6.7.1 Changing Monopolar Power Remotely
2.7.2 Cleaning
1. Select Remote Power Control by pressing
The exterior of the ESU may be cleaned by wip-
the Remote Power Control Key.
ing it with a cloth that has been dampened (not
2. Double click the CUT button on the acces- dripping) with a mild detergent or mild disinfect-
sory to adjust the cut power or double ing solution.
click the COAG button to adjust the
coagulation power. 2.7.3 Periodic Inspection
3. An acceptance tone will sound, allowing The System 5000™ should be visually inspected
power adjustments only from the accessory at least every year. This inspection should include
where the double click was detected. checks for:
4. Only the Power Indicator for the associated • Damage to the power cord.
power adjustment selected will be illuminated. • Damage to the power plug.
5. Only the Remote Power Control Key on the • Tightness of the power plug.
front panel will be functional.
• Tightness of the volume control knob.
6. Depress CUT on the accessory to increase
• Proper mating, cleanliness and absence of
power or depress COAG to decrease
damage to the patient connectors.
power. An audible tone will sound for
each power increment change. • Obvious external or internal damage to the
ESU.
7. A short up or down tone will sound with
each one-watt step. • Accumulation of lint or debris within the
ESU or heatsink.
8. As the cut or coag buttons on the
accessory are held down for more than 2.7.4 Periodic Performance Testing
nine one-watt steps, the power adjustment
The System 5000™ should be performance tested
will be accel- erated and a continuous tone
by a Hospital Qualified Biomedical Technician at
will sound. Releasing the switch and then
least every year. Each ESU is supplied with a seri-
pressing once again will start the single
alized Product Test Data Sheet, which tabulates
step function.
the results of the factory tests performed on the
9. To end Remote Power Control: ESU. This data may be used as a reference for
a) Double click either CUT or COAG. subsequent tests and should be made available to
-OR- the Hospital Qualified Biomedical Technician con-
ducting the tests.
b) Turn off Remote Power Control Mode.
-OR- 2.8 In Case of Difficulty
c) Do not press CUT or COAG buttons for 2.8.1 Dispersive Electrode Alarm
3 seconds and the function will time
Trouble with the dispersive electrode is indicated
out. by red illumination of the Dispersive Electrode
10. An acceptance tone will sound, returning Status / Alarm Indicators. Activation attempts
control for normal operation. will result in an audible fault alarm. Replace the
dispersive electrode if any patient contact has been
2.7 User Maintenance
lost.
2.7.1 General Maintenance Information If a dispersive electrode or A.R.M.™ alarm is
sounded intraoperatively, physically confirm prop-
While the System 5000™ has been designed
er dispersive electrode attachment to the patient
and manufactured to high industry standards,
and confirm that the display falls within the set
it is recommended that periodic inspection and
range.
performance testing be performed by a Hospital
Qualified Biomedical Technician using techniques 2.8.1.1 Single Dispersive Electrode Alarm
described in the ConMed System 5000™ Service
If a Single Dispersive Electrode alarm condition
Manual (Catalog Number 60-8017-ENG) to
occurs, confirm that a single dispersive electrode
ensure continued safe and effective operation.

2-
is attached to the ESU. Check all dispersive elec-
cable, a short between the two pads on the
trode cable connections and replace the dispersive
dispersive electrode, or some fault within the
electrode or cable if necessary.
ESU. Replace the dispersive electrode while
2.8.1.2 Dual Dispersive Electrode Alarm ensuring the dispersive electrode makes con-
tact only with the patient.
If a Dual Dispersive Electrode alarm condition
occurs, check the Dual Dispersive Electrode Status 2.8.2 Acc Codes
/ Alarm Indicator for clues to the problem:
Acc Codes are most often caused by faults in
a. If only the Dual Dispersive Electrode Status/ accessories connected to the ESU. The fault can
Alarm Indicator flashes red, the resistance is often be corrected in the operating room with-
too high. This can be caused by out a service call. The following list gives the
inappropri- ate choice of a site for the meaning of each code. For each code, check the
dispersive elec- trode, a broken cable or indicated accessory for proper operation. If the
poor connections to the ESU. fault persists, unplug the accessory, turn the ESU
b. If both the Single and Dual Dispersive off and then turn the ESU back on. If the fault
Electrode Status / Alarm indicators flash red is still present, call a Hospital Qualified
in unison, the impedance is too low. This Biomedical Technician for assistance.
condition can be caused by a short in the

Acc Display Code Meaning and Solution Solution


Acc FS Monopolar Footswitch Shorted Ensure footswitch treadle is not depressed.
Acc bPF Bipolar Footswitch Shorted Ensure footswitch treadle is not depressed.
Acc LH Left Hand Monopolar Accessory Shorted Replace hand controlled accessory.
Acc rH Right Hand Monopolar Accessory Shorted Replace hand controlled accessory.
Acc bP Bipolar Accessory Shorted Replace bipolar accessory.
Acc CP Control Panel Key Stuck Ensure no control panel keys are depressed on
power-up.

2.8.3 Err Codes 2.9 Environmental Protection


Err Codes generally cannot be corrected in The shipping container and packing material
the operating room and require the assistance should be retained in the event the ESU must
of a Hospital Qualified Biomedical Technician. be returned for factory service. At the end of
Occasionally, turning the ESU off and back on the
will clear an Err fault and resume normal opera- equipment’s life, it should be disposed of in accor-
tion of the ESU. dance with your local regulations. Component
2.8.4 If All Else Fails materials are:
• Aluminum enclosure and heatsinks.
Contact CONMED Electrosurgery Technical
Services at the phone or fax numbers listed on • The ESU rear handle is aluminum.
the inside front cover of this manual. Please have • Thermoset printed wiring boards containing
the model and serial numbers from the rear panel miscellaneous electronic components.
nameplate along with a description of the prob- • Transformers made of steel and copper.
lem, including power settings, accessories in use
• Mains cord made of thermoplastic and copper.
and the fault code.
• Shipping container is cardboard; packing
materials are a combination of Urethane foam
and Polyethylene film.

2
A D
CUT
RF RF

SINGLE FOIL ELECTRODE DUAL FOIL ELECTRODE COAG


B C
NEUTRAL ELECTRODE CONNECTIONS

CUT
MONOPOLAR FOOTSWITCH CONNECTIONS
COAG A C

RF
B

MONOPOLAR HANDSWITCHED ACTIVE CONNECTIONS BIPOLAR FOOTSWITCH CONNECTIONS

RF HANDSWITCH (OPTIONAL)
RF

BIPOLAR ACTIVE CONNECTIONS

Figure 2.4 Accessory Schematics

Figure 2.5 Accessory Connections

2-

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