Operator’s Manual

E lectrosurgical G enerator
 LIMITED WARRANTY
For a period of two years following the date of delivery,
CONMED Corporation warrants the CONMED System
2450™ 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.

STERILE EO
© 2012 CONMED Corporation
EC REP

525 French Road

MdSS GmbH

Utica,
Schiffgraben 41
New
D-30175 STERILE
York 13502-5994
Hannover USA R
Germany

STERILE
U.S. Patent Numbers 6,830,569 - 6,875,210 - 6,948,503 -A
7,540,871 - D552241 and other patents pending.

2
For Technical Service0123
or Return Authorization
LOT Phone:
303-699-7600 / 1-800-552-0138 Extension 5274
Fax 303-699-1628

For Customer Service or to order parts phone:

CUT COAG

1-800-448-6506 / 315-797-8375 / Fax 315-735-6235

or contact your CONMED Representative.
EC REP
STERILE EO
European Authorized
MdSS GmbH Representative
MDSS GmbH
Schiffgraben 41
STERILE R
D-30175 Hannover
Schiffgraben
Germany 41
D - 30175 Hannover
Germany
STERILE A 9083

The revision level of this manual is specified by the

2
highest revision letter found on either theLOT
0123
~
inside front cover
or enclosed errata pages (if any).

Manual Number 60-2451-ENG Rev. L CUT COAG

Unit Serial Number_________________________________

9083

~
 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................................................................................. 1-1
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...................................................................................................... 1-9
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........................................................................................................................ 1-12
1.4 Output Characteristic Curves .................................................................... 1-13
2.0 Installation and Operation................................................................. 2-1
2.1 Initial Inspection.......................................................................................... 2-1
2.2 Installation................................................................................................... 2-1
2.3 Controls, Displays and Connectors.............................................................. 2-1
2.3.1 Control Panel..................................................................................................................... 2-1
2.3.2 Output Panel...................................................................................................................... 2-3
2.3.3 Rear Panel.......................................................................................................................... 2-4
2.4 Preliminary Checks...................................................................................... 2-5
2.4.1 Preliminary Functional Testing........................................................................................... 2-5
2.4.2 Preliminary Performance Testing ....................................................................................... 2-6
2.5 Set Up For Use............................................................................................ 2-6
2.6 Operation..................................................................................................... 2-8
Section Title Page
2.7 User Maintenance........................................................................................ 2-9
2.7.1 General Maintenance Information...................................................................................... 2-9
2.7.2 Cleaning............................................................................................................................. 2-9
2.7.3 Periodic Inspection............................................................................................................. 2-9
2.7.4 Periodic Performance Testing............................................................................................. 2-9
2.8 In Case of Difficulty..................................................................................... 2-9
2.8.1 Dispersive Electrode Alarm................................................................................................ 2-9
2.8.1.1 Single Dispersive Electrode Alarm...................................................................................... 2-9
2.8.1.2 Dual Dispersive Electrode Alarm....................................................................................... 2-9
2.8.2 Acc Codes........................................................................................................................ 2-10
2.8.3 Err Codes......................................................................................................................... 2-10
2.8.4 If All Else Fails................................................................................................................. 2-10
2.9 Environmental Protection.......................................................................... 2-10

Figure/Title Page
Figure 1.1 Output Power vs. Power Setting......................................................................................... 1-13
Figure 1.2 Open Circuit Peak Voltage vs. Power Setting...................................................................... 1-14
Figure 1.3 Load Regulation, Monopolar Pure Cut.............................................................................. 1-14
Figure 1.4 Load Regulation, Monopolar Blend................................................................................... 1-14
Figure 1.5 Load Regulation, Monopolar Hi Blend*............................................................................ 1-15
Figure 1.7 Load Regulation, Monopolar Spray Coag.......................................................................... 1-15
Figure 1.6 Load Regulation, Monopolar Standard Coag..................................................................... 1-15
Figure 1.8 Load Regulation, Bipolar Micro......................................................................................... 1-16
Figure 1.9 Load Regulation, Bipolar Macro........................................................................................ 1-16
Figure 2.1 System 2450™ Control Panel................................................................................................ 2-2
Figure 2.2 System 2450™ Output Panel................................................................................................ 2-3
Figure 2.3 System 2450™ Rear Panel.................................................................................................... 2-4
Figure 2.4 Accessory Schematics............................................................................................................ 2-5
 General Information
Section 1.0

CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE

ORDER OF A PHYSICIAN.
This manual provides the set up and operating • Simultaneous activation in non-contact
instructions for the System 2450 Electrosurgical monopolar coagulation modes.
Unit (ESU). Electrosurgery can be dangerous • Channeled accessory receptacles direct plugs
to patients, staff and other equipment if mis- into position, making attachments less cum-
used. Please understand and follow the warnings bersome.
and cautions that are included in this manual.
• Integrated operating room control system
Technical specifications, performance characteristic
capability.
curves and user maintenance instructions are also
included. • Integrated interface for activation of smoke
evacuators and similar devices.
The System 2450 provides a broad range of capa-
bilities in a single, general-purpose electrosurgical 1.1 Cautions
generator. This rugged ESU fulfills the operation-
This equipment, in conjunction with connected
al and safety needs of the modern operating room
accessories, is intended to produce high-frequency
by providing:
electrical energy for the controlled destruction of
• Two monopolar cutting modes: Pure and tissue.
Blend.
Safe and effective electrosurgery is dependent not
• Two monopolar coagulation modes: Spray only on equipment design, but also on factors
and Standard. under the control of the operator. It is important
• Two bipolar modes: Micro and Macro that the instructions supplied with this equipment
• Radio Frequency (RF) isolated and indepen- be read, understood and followed in order to
dent outputs. ensure safe and effective use of the equipment.
• The proven Automatic Return Monitor 1.1.1 Cautions For Equipment Preparation
(A.R.M.™) contact quality monitoring sys-
• Use only accessories that meet the requirements
tem.
of Section 1.2, Section 1.4, and Figure 2.4.
• Continuous microprocessor safety monitor- Use of other accessories may result in increased
ing. emissions or decreased immunity of the ESU.
Features include: • Reusable accessory cables should be periodically
• Energy Synchronous Processing Technology function and safety tested in accordance with
delivers optimal clinical effects in all opera- the original manufacturer’s instructions.
tional modes through the continuous synchro- • Visually inspect all accessories before each use
nization of current and voltage. to verify the integrity of insulation and the
• Automatic programming restores the ESU to absence of obvious defects. In particular, elec-
the last settings used. trode cables and endoscopic accessories should
• Ability to change power settings from the be checked for damage to the insulation.
control panel while the ESU is activated. • The System 2450 is equipped to connect two
• One handswitched / footswitched combina- monopolar accessories at one time for the con-
tion receptacle and a separate handswitched venience of the surgical staff. Unused acces-
receptacle enable multiple accessory connec- sories should be stowed in a safe, electrically
tions. insulated place such as a non-conductive holster
that is isolated from the patient. CONMED

1-1
 recommends accessories not be connected System 2450. Do not use ground-referenced
unless needed. ESUs with the System 2450.
• Never connect more than one accessory at • A failure in the ESU could cause an unintended
a time to any one receptacle. This does not increase in output power. Verify that the ESU
include the dispersive electrode receptacle when is functioning correctly prior to use.
the appropriate CONMED adapter is used. • Prior to use, verify that devices connected to
• Use only a hospital grade, 3-prong, power cord the Activation Relay Connector function prop-
rated to meet the specifications in Section 1.2 erly in a manner that is synchronized with ESU
and all of the requirements for safe grounding power delivery.
of the ESU. The user should verify that the • Equipment connected to the Serial Interface
power receptacle with which this ESU is used Connector must be approved by CONMED
is properly grounded, correctly polarized and of and must be connected in accordance with
the proper frequency per Section 1.2. Do not instructions accompanying the equipment.
use ground “cheater plugs” or extension cords. Verify proper operation prior to ESU use.
Failure to adhere to this warning may cause
increased leakage currents. 1.1.2 Cautions For Patient Preparation
• Do not place liquid containers on top of • Electrosurgery should NEVER be performed
the ESU. Wipe spilled liquids off the ESU in the presence of flammable anesthetics, flam-
immediately. To preclude inadvertent entry of mable prep solutions or drapes, oxidizing gases
liquids, do not operate this ESU except in its such as Nitrous Oxide (N2O) or in oxygen-
normal position. enriched environments. The risk of igniting
• Do not stack other devices or equipment flammable gases or other materials is inherent
on top of or adjacent to the System 2450. in electrosurgery and cannot be eliminated by
The CONMED Stacking Adapter (Cat. No. device design. Precautions must be taken to
60-7161-001) allows two System 2450 units to restrict flammable materials and substances
be stacked in a safe manner. from the electrosurgical site. They may be
present in the form of an anesthetic, life sup-
• Confirm all accessories are properly connected
port, skin preparation agent, produced by
to the appropriate receptacles before powering
natural processes within body cavities or origi-
the ESU.
nate in surgical drapes, tracheal tubes or other
• To minimize the risk of burns when adapting materials. There is a risk of pooling of flam-
accessories, use only CONMED Bovie-style mable solutions in body depressions such as
adapters (Cat. Nos. 60-0823-001 and 60-6790- the umbilicus and in body cavities, such as the
001). vagina. Any fluid pooled in these areas should
• Potentially hazardous conditions may exist be removed before the high frequency surgical
when accessories of similar connector types are equipment is used. Due to the danger of igni-
combined. Be certain accessories are appropri- tion of endogenous gases, the bowel should be
ate for the type of generator output used. Use purged and filled with nonflammable gas prior
only CONMED Electrosurgery footswitches. to abdominal surgery. To avoid the risk of tra-
Confirm bipolar leads are connected only to the cheal fires, never use electrosurgery to enter the
bipolar receptacles. Connecting bipolar accesso- trachea during tracheotomy procedures.
ries to monopolar outputs may result in patient • Only non-flammable agents should be used for
injury. cleaning and disinfection wherever possible.
• Do not reuse disposable (single use) accesso- • Exercise care when moving the ESU to avoid
ries. electrostatic charge buildup in the presence of
• Do not use cords as handles as damage to the flammable materials, as there is a risk of ignit-
insulation and increased risk of burns or other ing these materials if a spark should occur.
injury may result. • This ESU is equipped with the Automatic
• Interference may occur between the RF signals Return Monitor (A.R.M.), which monitors
of the System 2450 and ground-referenced the quality of the dispersive electrode con-
ESUs that are used simultaneously with the nection. When a correctly functioning single

1-2
 dispersive electrode is connected to the ESU, • When high frequency surgical equipment and
A.R.M. verifies the connections between the physiological monitoring equipment are used
ESU, the dispersive electrode cable and the simultaneously on the same patient, all moni-
dispersive electrode. It DOES NOT verify that toring electrodes should be placed as far as pos-
a single dispersive electrode is in contact with sible from the surgical site and dispersive elec-
the patient. When using a dual dispersive elec- trode. Needle monitoring electrodes are not
trode, A.R.M. confirms the total resistance is recommended. Monitoring systems incorporat-
within the preset safety range. For this reason, ing high frequency current limiting devices are
use of a dual dispersive electrode with A.R.M. recommended whenever possible.
can provide greater safety than use of a single • The active electrode should not be used in the
dispersive electrode. Proper application and vicinity of electrocardiograph electrodes.
visual inspection of the dispersive electrode is
• Heat applied by thermal blankets or other
required for safe operation.
sources is cumulative with the heat pro-
• The use and proper placement of a dispersive duced at the dispersive electrode (caused by
electrode is a key element in safe and effective electrosurgical currents). Choosing a dispersive
electrosurgery. Follow manufacturer’s direc- electrode site that is remote from other heat
tions and recommended practices for the prepa- sources may minimize risk of a patient injury.
ration, placement, use, surveillance and removal
• Electrosurgery, by its nature produces sig-
of any dispersive electrode supplied for use
nificant levels of electromagnetic interference
with this electrosurgical unit.
(EMI) when the ESU is activated. This EMI
• Apply the dispersive electrode over a well-vas- may damage or impair the function of other
cularized muscle mass that is thoroughly clean electronic equipment in the operating room,
and dry. Clean site and clip hair as necessary especially equipment that makes contact with
per hospital policy, to provide adequate elec- the patient. Adverse effects can only be miti-
trical connection. Avoid placement over scar gated by use of equipment specifically designed
tissue, bony prominences or other areas where to tolerate electrosurgical interference. Cables
pressure points on small areas might develop. subject to flexing should be inspected frequent-
• Because of the risk of burns, needles should ly for shielding integrity.
never be used as a dispersive electrode for • Other equipment in the operating room,
electrosurgery. The entire area of the dispersive including portable or mobile communications
electrode should be placed so that the entire equipment, may produce EMI, which can affect
conductive area is in firm contact with an area the function of the ESU. Adverse effects can
of the patient’s body that has a good blood only be mitigated by use of equipment with
supply and is as close to the operative site as EMI characteristics proven below recognized
possible. In general, electrosurgical current limits. In the event of suspected interference
paths should be as short as possible and should from other equipment, discontinue use of the
run either longitudinally or in a diagonal direc- ESU until the problem can be remedied.
tion to the body, not laterally and under no
• The patient should not be allowed to come
circumstances lateral to the thorax.
into contact with metal items that are grounded
• Dispersive electrodes and probes of monitor- or have an appreciable capacitance to earth.
ing, stimulating and imaging devices can pro- Examples of this would be operating tables,
vide paths for high frequency currents even if supports, etc.
they are battery powered, insulated or isolated
• Jewelry and other metallic items can cause
at 50/60 Hz. The risk of burns can be reduced
localized burns if they make contact with
but not eliminated by placing the probes as far
grounded items and should be removed from
away as possible from the electrosurgical site
the patient prior to use of electrosurgery.
and the dispersive electrode. Protective imped-
ances incorporated in the monitoring leads may • Skin to skin contacts, such as between the arm
further reduce the risk of these burns. Needles and body of a patient or between the legs and
should not be used as monitoring electrodes thighs, should be avoided by the insertion of
during electrosurgical procedures. dry gauze.

1-3
• The use of electrosurgery on patients with FDA twice a year. Patient deaths related to the
cardiac pacemakers, AICDs, neurostimulators use of a medical device must be reported to the
or other active implants is potentially hazard- manufacturer and the FDA. For further infor-
ous. The implant may be irreparably dam- mation, please contact the Regulatory Affairs
aged and/or the high frequency energy of the Department of CONMED Electrosurgery at
electrosurgical output may interfere with the 800-552-0138, 303-699-7600 or FAX 303-
function of the implant. Ventricular fibrilla- 699-9854.
tion or neuromuscular stimulation may occur. • Do not use monopolar electrosurgery on
Precautions should be taken to ensure the small appendages, as in circumcision or finger
patient’s well-being is maintained in the event surgery, as it can cause thrombosis and other
of such interaction. The manufacturers of the unintended injury to tissue proximal to the
implants should be consulted for advice before surgical site. Should the surgeon decide that
operating on a patient with an implant. These the bipolar electrosurgical technique is accept-
precautions also apply to operating room per- able for circumcision, do not apply the bipolar
sonnel with similar implants. electrosurgical current directly to circumcision
• To minimize the possibility of cardiac pace- clamps.
maker interference, place the dispersive elec- • Apparent low power output or failure of
trode such that the electrosurgical current path the electrosurgical equipment to provide the
does not intersect the path of the pacemaker or expected effect at otherwise normal settings
leads. may indicate faulty application of the dispersive
1.1.3 Cautions For Use electrode, failure of an electrical lead or exces-
sive accumulation of tissue on the active elec-
• Safe and effective electrosurgery is dependent trode. Do not increase power output before
not only on equipment design, but also on fac- checking for obvious defects or misapplication
tors under the control of the operator. It is of the dispersive electrode. Check for effec-
important that the instructions supplied with tive contact of the dispersive electrode to the
this equipment be read, understood and fol- patient anytime the patient is moved after ini-
lowed in order to ensure safe and effective use tial application of the dispersive electrode.
of the equipment. The System 2450 is capable
• Studies have shown that smoke generated dur-
of causing physiological effects, including
ing electrosurgical procedures may be harmful
burns to the patient or operator. Only properly
to surgical personnel. These studies recom-
qualified and trained operators should perform
mend using a surgical mask and adequate ven-
electrosurgery. The operator and their support
tilation of the smoke using a surgical smoke
personnel must be diligent in assuring that the
evacuator or other means.
ESU is properly configured and that proper
settings are used. The ESU must be in a loca- • In the event that the system resets due to a
tion that assures that the operator or their sup- power interruption or low voltage, check the
port personnel can readily verify the settings. contact of the dispersive electrode prior to
resuming electrosurgery.
The System 2450 is capable of causing physi-
ological effects, including burns to the patient • If a dispersive electrode or A.R.M. alarm is
or operator. sounded intraoperatively, physically confirm
proper dispersive electrode attachment to the
• PLEASE NOTE: Federal law (U.S.A.) requires
patient and confirm that the display falls within
that all health care facilities must report to the
the set range. Smooth the dispersive electrode
manufacturer of a medical device, any death or
surface with hand to ensure electrode contact to
serious injury or illness to a patient related to
patient skin. Replace the dispersive electrode if
the use of a medical device. Serious injuries
necessary.
or illness involving the use of a medical device
must be reported to the manufacturer of the • Some equipment and/or techniques fall outside
device (or to the FDA if the manufacturer of the intended use of standard electrosurgery
the device is not known) within 10 working dispersive electrodes, such as application of
days of the incident. Summary reports of such high current, long activation times, or use of
injuries must also be submitted directly to the conductive fluid (e.g. tissue ablation, joint abla-

1-4
 tion, etc.). In these non-traditional conditions, tact electrosurgical electrodes (either active or
there is a risk that excess heat may build up in dispersive) while the RF output of the ESU is
standard dispersive electrodes and may pose a energized.
risk to the patient. • The electrodes of recently activated accesso-
• Simultaneous activation can be used in both ries may be hot enough to burn the patient or
Standard and Spray monopolar coagulation ignite surgical drapes or other flammable mate-
modes. Caution should be used as the output rial.
from either active electrode may change as a • Do not ignore unexpected tones. Check to
result of activation of a second output or end- determine the cause of the tone, otherwise
ing activation of an output. Power sharing is injury can occur.
unlikely to be equal because of differences in
• The Active Electrode delivers both Cut and
electrode to tissue distance and other factors.
Coag effects - use caution when selecting the
This unequal power sharing can be enough
proper activation request switch.
to stop power delivery to one electrode if the
second electrode is close to tissue and the first • Temporarily unused active electrodes should be
electrode is somewhat above the tissue. The stored in an electrically insulated holster. The
motion or deactivation of one electrode can unused active electrode should never be placed
cause the other electrode to start delivering on the patient. This is especially important for
power when it had been too far away from laparoscopic procedures.
tissue to arc before the first electrode change. • Ensure electrodes are properly installed with a
Simultaneous activation can also increase leak- snug fit in accessory handles.
age currents, which can be hazardous to the • Ensure that the footswitches are not inadver-
patient. It is recommended that a second tently depressed in order to prevent accessories
electrosurgical generator be used when it is nec- from being unintentionally activated. Place
essary to perform simultaneous operation. footswitches in locations that necessitate delib-
• The cables to the surgical electrodes (active, erate action in order to activate the footswitch.
bipolar or dispersive electrodes) should be Use caution when selecting the correct
positioned in such a way that contact with the footswitch to activate.
patient or other leads is avoided.
1.1.4 Cautions For Testing or Servicing
• Confirm the desired electrosurgical mode is
selected prior to use to ensure output character- • Service should not be attempted without ref-
istics are suitable for the intended procedure. erence to the System 2450 Service Manual
(Catalog Number 60-2454-ENG), provided
• Confirm the desired bipolar mode is selected
by Conmed. The Service Manual provides the
prior to use to ensure output characteristics are
Preventative Maintenance (PM) requirements,
suitable for the intended procedure.
calibration instructions, circuit diagrams, and
• The output power selected should be as low as circuit components listing necessary for per-
possible and activation times should be as short forming service on the System 2450.
as possible for the intended purpose.
• This electrosurgical unit should be tested by a
• The clinical use of electrosurgery is intermittent Hospital Qualified Biomedical Technician on a
in nature. This ESU should not be activated periodic basis to ensure proper and safe opera-
continuously for extended periods of time. tion. It is recommended that examination of
• When uncertain of the proper setting for the the ESU be performed at least yearly.
power level in a given procedure, start with a • No modification to this equipment is allowed.
low setting and increase as required.
• Advice to the responsible organization that the
• Observe all caution and warning symbols print- assembly of the ME systems and modifications
ed on the ESU. during the service life shall be evaluated based
• The operating room staff should never touch upon the requirements of IEC 60601-1 3rd
the patient and the connectors in the ESU Editon
simultaneously • Refer all servicing to a Hospital Qualified
• The operating room staff should never con- Biomedical Technician. Your CONMED sales

1-5
 representative will be happy to assist you in necessary nor desirable.
getting your equipment serviced. • Since the clinical use of electrosurgical units
• High voltages are developed within the ESU is intermittent in nature with duty cycles on
that are accessible when the top cover is the order of 10%, this ESU is not designed
removed. These voltages are potentially dan- to operate for extended periods of continuous
gerous and should be treated with extreme cau- output. When testing, it is recommended that
tion. duty cycles be limited to 15 seconds activation
• The high voltage DC power supply in the with delays of 30 seconds between activations.
System 2450 is equipped with a bleeder resistor • Activating the System 2450 in other than its
to dissipate the charge on the filter capacitor. normal operating position impairs the heat dis-
However, it takes several seconds after power sipation capability of the heat sink.
is removed to bleed that charge down to a safe • Ensure that the two top-cover screws are tight-
level. It is recommended that at least thirty ened and always perform a power-up check to
(30) seconds be allowed to elapse before touch- confirm a normal power-up sequence before
ing or attempting to perform any maintenance returning the ESU to service.
involving the power supply or power amplifier.
• Improperly connecting test equipment can
• Never remove or install any parts with the cause electric shock and destruction of equip-
power cord connected to AC mains. ment.
• Avoid contact with the output leads when the • Turn unit off and wait until storage capacitors
ESU is activated. Periodically inspect the test have discharged before connecting test equip-
leads used for the output connections for obvi- ment.
ous defects.
• Loss of power supply isolation can cause elec-
• Although this ESU will withstand momentary trical shock. When servicing the high voltage
short circuits on the output, prolonged short power supply, assume internal isolation is com-
circuits may damage the ESU. Short-circuiting promised until verified otherwise.
the output should be avoided since it is neither

1.1.5 Electromagnetic Compatibility

Following are guidance and manufacturer’s declarations regarding electromagnetic compatibility for the
System 2450.
1.1.5.1 EN/IEC 60601-1-2 Table 201

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The System 2450 Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 2450 Electrosurgical Unit should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 2 The System 2450 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 2450 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

1-6
1.1.5.2 EN/IEC 60601-1-2 Table 202

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The System 2450 Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 2450 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 typi-
burst supply lines supply lines cal commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/
output lines output lines
Surge ±1 kV differential ±1 kV differential Mains power quality should be that of a typi-
mode mode cal commercial or hospital environment.
IEC 61000-4-5
±2 kV common ±2 kV common
mode 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 2450 Electrosurgical
ply input lines 40 % UT 40 % UT
Unit requires continued operation during
power mains interruptions, it is recommended
IEC 61000-4-11 (60 % dip in UT) (60 % dip in UT)
that the System 2450 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.

1-7
1.1.5.3 EN/IEC 60601-1-2 Table 204

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The System 2450 Electrosurgical Unit is intended for use in the electromagnetic environment specified below. The
customer or the end user of the System 2450 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 2450
Electrosurgical Unit, including cables, than the recom-
mended 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 2450 Electrosurgical Unit is used exceeds the appli-
cable RF compliance level above, the System 2450 Electrosurgical Unit should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be neces-
sary, such as reorienting or relocating the System 2450™ Electrosurgical Unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [v1] V/m.

1-8
1.1.5.4 EN/IEC 60601-1-2 Table 206

Recommended separation distances between portable and mobile RF communications equipment

and the System 2450™ Electrosurgical Unit
The System 2450 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 2450 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 2450 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
50-60 120 104 127 7.1 8A
50-60 100 90 110 8.4 10A
50-60 220 198 242 4.0 5A
50-60 230-240 207 264 3.7 5A

*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).
1.2.3 Regulatory Compliance
Designed to comply with Medical Electrical Equipment Standards (IEC60601-1:2005, IEC60601-1-2:
2005, IEC60601-1-6: 2004, IEC60601-1-8: 2005, IEC60601-2-2:2009, ANSI/AAMI HF18: 2001).

1-9
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, Defibrillation-Proof.
Non-Ionizing Radiation.
1.2.4 Operation
Mode of operation: Intermittent 15 Sec on/30 Sec off.
1.2.5 Power Display Accuracy
The greater of 2% of maximum power setting for the selected mode or 15% of selected power setting.
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 at altitudes between 60 meters
below and 3000 meters above mean sea level.
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, and radiation.
Storage Conditions: -34°C to 65°C, at altitudes from –60 to +4500 meters above mean sea level (1020.5
hPa - 577.1 hPa) 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.
1.2.9 Audio Specifications
Cut = 523 Hz
Coag = 440 Hz
Bipolar = 440 Hz
Acc Fault = 847 Hz (pulsating)
Dispersive Electrode Alarm = 847 Hz (pulsating)
Err Fault = 847 Hz (pulsating)
Increase Power Level = 379 Hz
Decrease Power Level = 343 Hz
(All tones are 45 dbA minimum except Alarms, which are 65 dbA minimum)

1-10
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: 32 lb. (14.5 Kg)

Height: 7.0 inches (18 cm); Width: 14.4 inches (37 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 Crest Max Open Carrier Pulse

Power Load Factor* Circuit Voltage Freq. Repetition
(watts) (ohms) (Peak)** (KHz)** Freq. (KHz)
Monopolar
Pure Cut 300 500 1.4 – 2 at 50W 1100 390-410 N/A
Blend 200 500 2.0 – 2.6 at 50W 1200 390-410 24 – 26
Hi Blend*** 200 500 2.2 – 2.9 at 50W 1300 390-410 24 – 26
Standard Coag 120 500 5.6 – 6.6 at 50W 3200 485-505 38 – 42
Spray Coag 80 500 7.5 – 9.5 at 50W 5000 485-505 18 – 22
Bipolar
Micro Coag 70 50 1.4 – 2 at 50W 150 390-410 N/A
Macro Coag 70 300 1.4 – 2 at 50W 560 390-410 N/A

*Measured at rated load

**Measured in the open circuit condition.
***Hi Blend is only accessible by a Hospital Qualified Biomedical Technician – refer to the Service Manual for the
System 2450.

1-11
1.3 Explanation of Symbols 1.3.3 Output/Control Panel

1.3.1 Control Panel Dispersive Electrode –

Note: International System 2450 units use sym- Connection for monopolar
bols on the Control Panel. Some symbols are dispersive electrode.
replaced by words on the domestic (U.S.) units. Hand-controlled Monopolar
These words are indicated by bold text in the sym- Output: Connection for hand-
bol description. controlled monopolar acces-
sories.
Pure Cut waveform with
minimum thermal damage and
Bipolar Output: Connection
hemostasis.
for bipolar accessories.

Blend waveform with moderate

hemostasis
Caution: High voltage output.
Standard Monopolar
Coagulation Type CF: Patient connections
are isolated from earth and
resist the effects of defibrillator
Spray Monopolar Coagulation
discharge.
RF Isolated: Patient connec-
tions are isolated from earth at
Micro Bipolar Coagulation
high frequency.
There are specific warn-
ings or precautions associ-
Macro Bipolar Coagulation
ated with this device. Consult
Instructions prior to use.
Single Dispersive electrode Approximate alignment of
Status/Alarm Indicator for single pins (handswitch receptacle)
Single
monopolar dispersive electrodes
Dual Dispersive electrode Approximate alignment of
Status/Alarm Indicator for dual pins (combination receptacle)
Dual
monopolar dispersive electrodes

Approximate alignment of
Volume control: Activation tone pins (bipolar receptacle)

1.3.2 Interior Power on: connected to the

mains.
Power off: disconnected from
Protective Earth (Inlet
the mains.
Connector)
1.3.4 Rear Panel
High Voltage Circuitry Enclosure resists entry of verti-
cally falling water.

1-12
 Monopolar Footswitch
Consult accompanying docu-
Connector
ments prior to placing equip-
ment in service.
Activation relay connector.

This equipment intentionally Equipotential Ground

supplies non-ionizing RF ener- Terminal.
gy for physiological effect.
Replace fuse only with type
Explosion risk if used in the and rating as shown.
presence of flammable anes- __A ___V

thetics. Caution - High Voltage Inside

- Refer servicing to qualified
Do not operate in oxygen personnel.
enriched environments. Serial Interface Connector.

Bipolar Footswitch Connector Medical Electrical Equipment

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.

300

250

200
Output Power

150

100

50

0
0 50 100 150 200 250 300
Power Setting
Figure 1.1 Output Power vs. Power Setting

1-13
 4500

4000

3500

3000
Peak Voltage

2500

2000

1500

1000

500

0
0 50 100 150 200 250 300
Power Setting
Figure 1.2 Open Circuit Peak Voltage vs. Power Setting

350 250
300
300 200
200
250
Output Power (Watts)

Output Power (Watts)

150
200

150
100
150
100
100
50
50

0 0
0 500 1000 1500 2000 0 500 1000 1500 2000
Load Resistance (Ohms) Load Resistance (Ohms)

Figure 1.3 Load Regulation, Figure 1.4 Load Regulation,

Monopolar Pure Cut Monopolar Blend

1-14
 250 140
120
200 120
200
100
Output Power (Watts)

Output Power (Watts)

150
80

60
100
60
100
40
50
20

0 0
0 500 1000 1500 2000 0 500 1000 1500 2000
Load Resistance (Ohms) Load Resistance (Ohms)

Figure 1.5 Load Regulation, Figure 1.6 Load Regulation,

Monopolar Hi Blend* Monopolar Standard Coag

90
80
80

70
Output Power (Watts)

60

50

40
40
30

20

10

0
0 500 1000 1500 2000
Load Resistance (Ohms)

Figure 1.7 Load Regulation,

Monopolar Spray Coag

* Hi Blend is only accessible by a Hospital Qualified Biomedical Technician. Refer to the System 2450
Service Manual.

1-15
 80 80
70
70 70

60 70 60
Output Power (Watts)

Output Power (Watts)

50 50

40 40

30 30 35
35
20 20

10 10

0 0
0 200 400 600 800 1000 0 200 400 600 800 1000
Load Resistance (Ohms) Load Resistance (Ohms)

Figure 1.8 Load Regulation, Figure 1.9 Load Regulation,

Bipolar Micro Bipolar Macro

1-16
 Installation and Operation
Section 2.0

This section contains initial installation, prelimi- 2.3.1 Control Panel

nary checks and operating instructions for the
All controls, except for the volume controls, are
System 2450.
located on the front control panel. Figure 2.1
2.1 Initial Inspection illustrates the control panel.
Unpack the ESU upon receipt and physically 1. DUAL DISPERSIVE ELECTRODE
inspect it for any obvious damage that may have STATUS/ALARM INDICATOR: Indicates
occurred during shipment. A Hospital Qualified the status of a dual dispersive electrode when
Biomedical Technician should perform this inspec- the dual dispersive electrode is connected to
tion. Notify the carrier and your CONMED rep- the ESU.
resentative immediately if damage is found. The DUAL DISPERSIVE STATUS INDI-
CATOR will flash red prior to connection of
2.2 Installation any dispersive electrode or connection of a
The ESU may be mounted on a matching cart dual dispersive electrode that is not applied
or any stable cart or table. Locate the ESU to to the patient. This indicator will illuminate
allow the surgeon to view the display, typically at steady green after a dual dispersive electrode is
a distance of 1-3 meters, and to allow the circulat- applied to the patient and the contact quality
ing nurse to adjust ESU settings and respond to of the dual dispersive electrode is at an accept-
alarms, typically at a distance of 0-4 meters. able level.
WARNING: THE POWER CORD OF THE If contact quality deteriorates to a level that is
ESU SHOULD BE CONNECTED TO A unacceptable, the STATUS INDICATOR will
POWER SOURCE WHOSE VOLTAGE AND flash red and an alarm will sound.
FREQUENCY CHARACTERISTICS ARE 2. SINGLE DISPERSIVE ELECTRODE
COMPATIBLE WITH THOSE LISTED ON STATUS / ALARM INDICATOR: Indicates
THE NAMEPLATE OF THIS ESU. the status of a single dispersive electrode when
the single dispersive electrode is connected to
the ESU. This STATUS INDICATOR will
TO AVOID RISK OF ELECTRIC
flash red prior to connection of any dispersive
SHOCK,THIS EQUIPMENT MUST ONLY BE
electrode. This STATUS INDICATOR will
CONNECTED TO A SUPPLY MAINS WITH
illuminate steady green after a single disper-
PROTECTIVE EARTH.
sive electrode is acceptably connected to the
CAUTION: Since the ESU depends on both ESU.
natural convection for cooling, it should not
WARNING: THE SINGLE DISPERSIVE
be installed in a cabinet or similar enclosure. If
ELECTRODE STATUS / ALARM INDICATOR
mounted on a shelf or otherwise near a wall, allow
DOES NOT PROVIDE ANY INDICATION
a two-inch clearance around and above the ESU
OF THE CONTACT QUALITY BETWEEN
to permit free circulation of air along the sides of
THE SINGLE DISPERSIVE ELECTRODE
the ESU.
AND THE PATIENT.
2.3 Controls, Displays and Connectors If the quality of connection between the ESU
The numbers preceding the following paragraphs and the single dispersive electrode deteriorates
correspond to the numbered items in Figures 2.1, to a level that is unacceptable, this STATUS
2.2 and 2.3. INDICATOR will flash red and an alarm will
sound.

2-1
 23. Monopolar Cut Power Adjustment Keys 22. Monopolar 21. Monopolar 20. Monopolar 19. Monopolar Coag Power Adjustment Keys
Cut Activation Coag Power Coag Activation
18. Bipolar Power Digital Display
24. Monopolar Cut Power Digital Display Indicator Digital Display Indicator
17. Bipolar Activation Indicator

1. Dual Dispersive
Return CUT COAG BIPOLAR
Electrode Status/Alarm
Indicator

001 010 00
Dual

2. Single Dispersive 16. Tone Loudness

Electrode Status/ Single Adjustment Keys
Alarm Indicator Pure Blend Standard Spray Micro Macro

3. Pure Cut Indicator

4. Pure Cut Mode
Select Key 15. Bipolar Power
Adjustment Keys
System 2450 TM

14. Macro Bipolar Mode

Select Key
13. Macro Bipolar Indicator
5. Blend Indicator
7. Standard Coag 10. Spray Mode 12. Micro Bipolar Mode Select Key
6. Blend Mode
Indicator Select Key
Select Key 11. Micro Bipolar Indicator
8. Standard Mode 9. Spray Coag
Select Key Indicator

Figure 2.1 System 2450™ Control Panel

3. PURE CUT INDICATOR: Illuminates when 14. MACRO BIPOLAR MODE SELECT KEY:
Pure Cut is selected as the monopolar cut Press this key to select Macro as the bipolar
mode. mode.
4. PURE CUT MODE SELECT KEY: Press 15. BIPOLAR POWER ADJUSTMENT
this key to select Pure Cut as the monopolar KEYS: Adjusts the output power setting of
cut mode. the selected bipolar mode.
5. BLEND INDICATOR: Illuminates when 16. TONE LOUDNESS ADJUSTMENT
Blend is selected as the monopolar cut mode. KEYS: Adjusts the loudness of the activation
6. BLEND MODE SELECT KEY: Press this tones. This does not adjust the loudness of
key to select Blend Mode as the monopolar the alarm tones.
cut mode. 17. BIPOLAR ACTIVATION INDICATOR:
7. STANDARD COAG INDICATOR: This indicator lights when the ESU is acti-
Illuminates when Standard is selected as the vated in the selected bipolar mode.
monopolar coagulation mode. 18. BIPOLAR POWER DIGITAL DISPLAY:
8. STANDARD MODE SELECT KEY: Press Indicates the bipolar mode power level set
this key to select Standard as the monopolar using the Bipolar Power Adjustment Keys.
coagulation mode. 19. MONOPOLAR COAG POWER
9. SPRAY COAG INDICATOR: Illuminates ADJUSTMENT KEYS: Adjusts the output
when Spray is selected as the monopolar power setting of the selected monopolar coag-
coagulation mode. ulation mode.
10. SPRAY MODE SELECT KEY: Press this 20. MONOPOLAR COAG ACTIVATION
key to select Spray as the monopolar coagula- INDICATOR: This indicator lights when the
tion mode. ESU is activated in the selected monopolar
coagulation mode.
11. MICRO BIPOLAR INDICATOR:
Illuminates when Micro is selected as the 21. MONOPOLAR COAG POWER DIGITAL
bipolar mode. DISPLAY: Indicates the power setting in the
currently selected monopolar coagulation
12. MICRO BIPOLAR MODE SELECT KEY:
mode.
Press this key to select Micro as the bipolar
mode. 22. MONOPOLAR CUT ACTIVATION
INDICATOR: This indicator lights when the
13. MACRO BIPOLAR INDICATOR:
ESU is activated in the selected monopolar
Illuminates when Macro is selected as the
cut mode.
bipolar mode.

2-2
 29. Power Switch
25. Dispersive Electrode
Receptacle 26. Hand-Controlled
Monopolar Accessory
Receptacle
27. Combination Monopolar
Accessory Receptacle 28. Bipolar Accessory Receptacle

Figure 2.2 System 2450™ Output Panel

23. MONOPOLAR CUT POWER for use with the System 2450. This connec-
ADJUSTMENT KEYS: Adjusts the output tor will not accept pin-tip style connectors.
power setting of the selected cut mode. WARNING: PIN-TIP STYLE CONNECTORS
24. MONOPOLAR CUT POWER DIGITAL WILL NOT BE RELIABLY CAPTURED
DISPLAY: Indicates the power setting for the IN THE MONOPOLAR ACCESSORY
currently selected monopolar cut mode. RECEPTACLE AND WILL NOT PROVIDE
A RELIABLE CONNECTION. DO NOT
2.3.2 Output Panel
USE THE COMBINATION MONOPOLAR
The output panel contains the power switch and ACCESSORY RECEPTACLE FOR PIN-TIP
the accessory receptacles as illustrated in STYLE CONNECTORS.
Figure 2.2. 28. BIPOLAR ACCESSORY RECEPTACLE:
25. DISPERSIVE ELECTRODE RECEP- The Bipolar output is activated by the bipo-
TACLE: This receptacle accepts a standard lar footswitch or by hand-controlled bipolar
two-pin single or dual dispersive electrode accessories. CONMED accessories with fixed
plug. connection style plugs are recommended for
WARNING: NEVER CONNECT MORE this receptacle. For legacy connections with
THAN ONE ACCESSORY AT A TIME INTO two banana plug leads, connect these active
ANY OUTPUT RECEPTACLE. bipolar forceps leads to the outside connec-
tions.
26. HAND-CONTROLLED MONOPOLAR
ACCESSORY RECEPTACLE: Only the 29. POWER SWITCH: Primary power switch
accessories connected to this receptacle will for turning the ESU on and off.
activate this receptacle.
27. COMBINATION MONOPOLAR ACCES-
SORY RECEPTACLE: Accessories con-
nected to this receptacle can be activated
by either the controls on the connected
accessory or by the monopolar footswitch
that is connected to the System 2450. This
receptacle will also accept a standard three-
prong handswitched accessory connector, a
Bovie-style footswitched accessory connector,
or an approved Bovie-style adapter. Only
CONMED Bovie-style adapters (Cat. Nos.
60-0823-001 and 60-6790-001) are approved

2-3
 30. Speaker

39. Carrying Handle

31. Fuse Receptacles

38. Nameplate

32. Power Inlet

37. Serial Interface

33. Equipotential
Connector
Ground Connection
36. Activation
34. Bipolar Footswitch 35. Monopolar Relay Connector
Connector Footswitch Connector

Figure 2.3 System 2450™ Rear Panel

2.3.3 Rear Panel Bipolar Footswitch part numbers available:

The rear panel contains the footswitch connec- 60-5103-001
tors, power cord connector, fuses, and a carrying 60-5103-002
handle. Refer to Figure 2.3. 60-1650-001
30. SPEAKER: Sound from the speaker ema- 35. MONOPOLAR FOOTSWITCH
nates from this location. CONNEC-TOR: A 4-pin threaded con-
31. FUSE RECEPTACLES: For installation nector is designed to accept any dual-
of two mains fuses with ratings as noted in treadle monopolar footswitch available
Section 1.2. from CONMED Electro-surgery. Use only
32. POWER INLET: Supplies AC mains power CONMED Electrosurgery footswitches.
to the ESU. It should only be connected to a Other manufacturers’ foot- switches may not
source of power corresponding to that listed be compatible.
on the nameplate. Monopolar Footswitch PN: 60-6700-001
33. EQUIPOTENTIAL GROUND 36. ACTIVATION RELAY CONNECTOR: A
CONNECTION: Chassis ground connection receptacle for actuating smoke evacuators and
suitable for attachment of standard auxiliary similar devices when delivering electrosurgical
grounding cable when required for additional output. The maximum contact rating for this
protection against low frequency risk current. receptacle is 1 amp at 24 volts DC. Verify
Shall not be used for Safety Protective Earth that devices connected to this output func-
connection for this device or any other device tion properly in a manner that is synchronized
connected to this unit as a system. with ESU power delivery prior to use.
34. BIPOLAR FOOTSWITCH 37. SERIAL INTERFACE CONNECTOR:
CONNECTOR: A 3-pin threaded connec- This connector provides a means of connec-
tor designed to accept any single-treadle tion with operating room control centers.
bipolar footswitch available from CONMED Only equipment approved by CONMED
Electrosurgery. Use only CONMED should be connected to this interface.
Electrosurgery footswitches. Other manufac- Contact your CONMED Sales Representative
turer’s footswitches may not be compatible. or CONMED Customer Service at the num-
bers listed on the inside front cover of this
manual.

2-4
 RF RF
COAG
SINGLE FOIL ELECTRODE DUAL FOIL ELECTRODE

RF
NEUTRAL ELECTRODE CONNECTIONS

CUT
MONOPOLAR HANDSWITCHED ACTIVE CONNECTIONS
COAG
RF

HANDSWITCH (OPTIONAL)
RF
RF

MONOPOLAR HANDSWITCHED ACTIVE CONNECTIONS

BIPOLAR ACTIVE CONNECTIONS
A D
CUT RF
RF RF COAG
HANDSWITCH (OPTIONAL)
SINGLE FOIL ELECTRODE DUAL FOIL ELECTRODE B C

NEUTRAL ELECTRODE CONNECTIONS RF

MONOPOLAR FOOTSWITCH CONNECTIONS
CUT
A C BIPOLAR ACTIVE CONNECTIONS
COAG A D
CUT
B
COAG
RF BIPOLAR FOOTSWITCH CONNECTIONS B C

MONOPOLAR HANDSWITCHED ACTIVE CONNECTIONS

MONOPOLAR FOOTSWITCH CONNECTIONS

Figure 2.4 Accessory Schematics

RF A C

HANDSWITCH (OPTIONAL)

38. NAMEPLATE: Specifies model number, RF

b) During the test tone, displaying a total of
BIPOLAR FOOTSWITCH CONNECTIONS
serialBIPOLAR
number, nominal line voltages, frequen-
ACTIVE CONNECTIONS
A D
eight “8’s” on the three digital displays.
cy, current and fuse rating information.
CUT

COAG c) Illuminating all three activation indica-

39. CARRYING HANDLE B C
tors, all six key indicators, and two disper-
MONOPOLAR FOOTSWITCH CONNECTIONS sive electrode indicators.
2.4 Preliminary Checks
d) After the display test, the ESU will show
A C

Prior to initial installation and use of this ESU,

B the software revision level in the COAG
performance of the device
BIPOLAR FOOTSWITCH should be tested in
CONNECTIONS display window. The ESU is conducting
accordance with this manual. Results of that test- a power-on self-test during this interval.
ing should be compared to the results tabulated e) The internally selected Blend mode is
on the factory Test Data Sheet supplied with each indicated by either “BL L0” for the fac-
ESU. This data should be retained for future ref- tory default Blend mode or “BL KI” for
erence and comparison. Blend Hi.
2.4.1 Preliminary Functional Testing f) If there are no errors, normal operational
The following checks are recommended upon ini- parameters will then be displayed.
tial installation of the equipment and prior to each 6. Depress the Cut treadle of the monopolar
use of the instrument to avoid unnecessary delays footswitch. The dispersive electrode alarm
in surgery. See Figure 2.1 for location of controls should sound and Dispersive Electrode
and connectors. Indicators should flash alternating red. While
1. Ensure the Power Switch is OFF and no holding the Cut treadle, adjust the Tone
accessories are connected. Loudness controls over their full range and
verify there is no significant change in sound
2. Connect the power cable to a properly
level. Release the Cut footswitch and the
grounded and polarized mating power recep-
tone should stop.
tacle of the proper voltage and frequency.
7. Select each of the modes by pressing the
3. Connect a CONMED dual-treadle monopolar
Mode Select Keys and note the displayed
footswitch and a single treadle CONMED
power settings for each mode in the corre-
bipolar footswitch to their mating connec-
sponding displays.
tors at the rear of the ESU. Note: Use only
CONMED Electrosurgery footswitches. 8. Verify that the Pure Cut Mode can be selected
Although other types may fit, they may not and adjusted up and down by:
be functionally compatible. • Pressing the Pure Cut Mode Select Key
4. Make no connection to the Dispersive until the Pure Cut Indicator is illuminat-
Electrode Receptacle at this time. ed.
5. Set the Power Switch to the ON (“|”) posi- • Pressing the Monopolar Cut Power
tion. The ESU will perform a number of Adjustment Keys to increase and decrease
self tests to ensure functionality and allow the setting while verifying that the display
the operator to verify alarm functionality. As changes appropriately and verifying that
these self-diagnostics proceed, the user should no other displays change.
verify that the ESU responds by: • Pressing the Blend Mode Select Key and
a) Sounding a series of test tones. verifying that the setting for Blend match-
es the Pure Cut Mode power setting.

2-5
 9. Verify that each of the other modes can be Coag treadle and verify that the blue Coag
selected and adjusted up and down in the Activation Indicator illuminates until the
same manner as the Pure Cut Mode described Coag treadle is released.
above. The other modes include: 14. Connect a hand-controlled accessory to one
• Blend of the Monopolar Accessory Receptacles.
• Standard Coag Activate the Cut and Coag keys on the acces-
sory, one at a time, verifying that each con-
• Spray Coag
trol causes the correct indicator and tone to
• Bipolar Micro sound. Move the hand-controlled accessory
• Bipolar Macro to the other Monopolar Accessory Receptacle
Return all settings to the desired setting. and repeat.
10. Depress the bipolar footswitch. Confirm 15. Disconnect the single dispersive electrode
that the Bipolar Activation Indicator illu- and confirm that the System 2450 beeps three
minates and a bipolar activation tone is times and the Single and Dual Dispersive
sounded. While continuing to depress the Electrode Status / Alarm Indicators alternately
bipolar footswitch, adjust the Tone Loudness flash red.
Adjustment Keys over their full range to veri- 2.4.2 Preliminary Performance Testing
fy the function of that control and that sound
is audible at all positions. This control may After the ESU passes the Preliminary Functional
be left at any desired position. Release the Tests of Section 2.3.1, preliminary performance
bipolar footswitch and confirm the System testing may be conducted. Such testing is best
2450 returns to its idle state. Set the bipolar carried out by use of an electrosurgical generator
power setting to 1 watt and verify the bipo- tester. Use a non-inductive resistor with the same
lar hand control is functional by use of the value as the rated generator output impedance for
appropriate forceps or by connecting a jumper the best accuracy of the tester. (See Specifications,
between the center and right hand Bipolar Section 1.2).
Accessory Receptacle on the Output Panel. If no tester is convenient, the availability of thera-
The effect will be identical to depressing the peutic current may be ascertained subjectively by
bipolar footswitch. attempting to cut and coagulate on surrogate tis-
11. Verify that the Single and Dual Dispersive sue such as a piece of meat or fresh fruit, a wet
Electrode Status / Alarm Indicators alternately bar of soap or a sponge moistened with saline.
flash red. Connect a single dispersive elec- 2.5 Set Up For Use
trode to the Dispersive Electrode Receptacle.
Confirm the Single Dispersive Electrode 1. Ensure the Power Switch is OFF, and then
Status / Alarm Indicator is steady green. connect the power cable to a properly
12. Depress the Cut treadle of the Monopolar grounded and polarized mating power recep-
footswitch. The yellow Cut Activation tacle. Do not connect a dispersive electrode
Indicator should light and the cut activation at this time.
tone should sound. 2. Inspect and connect the desired monopolar or
13. While continuing to press the Cut treadle bipolar accessories to the connectors on the
of the footswitch, press the Coag treadle. front of the ESU. Refer to Figure 2.2.
The yellow Cut Activation Indicator should WARNING: ALWAYS STOW UNUSED
remain illuminated and the Cut activation ACCESSORIES IN A SAFE, INSULATED
tones should continue. Release the Cut LOCATION SUCH AS A HOLSTER. DO
treadle while continuing to press the Coag NOT PLACE ACTIVE ACCESSORIES ON
treadle and confirm that the yellow Cut THE PATIENT.
Activation Indicator extinguishes, the blue 3. Connect the footswitches, as required, to the
Coag Activation Indicator illuminates and rear of the ESU (not required if only hand-
the activation tone changes from Cut to controlled accessories are to be used). Use
Coag. Release the coag treadle and verify only CONMED Electrosurgery footswitches.
that the display returns to normal. Press the

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4. Set the Power Switch to the ON position. As per hospital policy, to provide adequate elec-
the ESU goes through its internal self-diag- trical connection. Avoid placement over scar
nostics, confirm the machine responds by: tissue, bony prominences or other areas where
a) Sounding a test tone. pressure points on small areas might develop.
b) During the test tone, displaying a total of 7. Inspect and connect the plug of the dispersive
eight “8’s” on the three digital displays. electrode cable to the Dispersive Electrode
Receptacle or to an appropriate adapter.
c) Illuminating all three activation indica-
tors, all six key indicators, and two disper- NOTE: This ESU incorporates A.R.M. cir-
sive electrode indicators. cuitry. The monitor will inhibit monopolar
operation of the ESU if its requirements for
d) After the display test, the ESU will show
the dispersive electrode have not been satisfied
the software revision level in the COAG
(see instruction 8).
display window. The ESU is conducting
a power-on self-test during this interval. 8. The A.R.M. dispersive electrode contact
quality monitor can automatically detect and
After the power-on self-tests, the ESU is
accept either single dispersive electrodes or
ready for use. If the ESU sounds a pulsat-
dual dispersive electrodes.
ing high tone, displays an “Err” fault code
or otherwise fails to respond as above, the The Single Dispersive Electrode Status /
ESU has failed one of its internal tests and Alarm Indicator indicates the status of a single
is not suitable for use. Before turning the dispersive electrode when the single disper-
power off, note the “Err” code displayed in sive electrode is connected to the ESU. This
the Power Displays to assist in the diagnosis. STATUS INDICATOR will flash red prior to
Contact your Hospital Qualified Biomedical connection of any dispersive electrode. This
Technician for repair if an “Err” code STATUS INDICATOR will illuminate steady
appears. green after a single dispersive electrode is
acceptably connected to the ESU. The Single
If the ESU sounds a pulsating high tone, dis-
Dispersive Electrode Status / Alarm Indicator
plays an “ACC” fault code and fails to respond
DOES NOT provide any indication of the
as above, the ESU has detected a problem
contact quality between the single dispersive
with one of the connected accessories. ACC
electrode and the patient.
fault code codes can often be corrected by
operating room staff. See Section 2.7.2 for If the connection between the ESU and
actions to correct “ACC” fault codes. the single dispersive electrode is broken,
the Single Dispersive Electrode STATUS
5. When using monopolar modes, select and
INDICATOR will flash red and an alarm will
prepare the patient dispersive electrode site
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 to
dispersive electrode need not be connected if the ESU.
only BIPOLAR operation is required. The STATUS / ALARM INDICATOR will
CAUTION: The use and proper placement of flash red prior to connection of any dispersive
a dispersive electrode is a key element in safe electrode or connection of a dual dispersive
and effective electrosurgery. Follow manufac- electrode that is not applied to the patient.
turer’s directions and recommended practices The DUAL DISPERSIVE ELECTRODE
for the preparation, placement, use, surveil- STATUS / ALARM INDICATOR will illu-
lance and removal of any dispersive electrode minate steady green with a dual dispersive
supplied for use with this electrosurgical unit. electrode that is installed and connected with
acceptable contact quality.
6. Apply the dispersive electrode over a well-vas-
cularized muscle mass that is thoroughly clean If the contact quality deteriorates to a level
and dry. Clean site and clip hair, as necessary that is unacceptable, the Dual Dispersive

2-7
 Electrode Status / Alarm Indicator will flash continuously held, power setting will
red and an alarm will sound. increase or decrease at an accelerated rate,
When alarm occurs, physically confirm with a series of short beeps, until the
proper dispersive electrode-to-patient contact. Power Adjustment Key is released.
Smooth the dispersive electrode surface with • Power settings above 30 watts are
hand to improve electrode contact to patient’s adjusted in 5-watt steps. Below 30 watts,
skin. Replace the dispersive electrode if dis- power settings are adjusted in 1-watt
persive electrode status/alarm indicator con- steps.
tinues to flash red. If unsure of the proper settings, use low
WARNING: DO NOT DEPEND power settings initially and make adjustments
SOLELY ON THE DUAL DISPERSIVE intraoperatively according to the surgeon’s
ELECTRODE STATUS / ALARM requests. Use of a written record of each
INDICATOR FOR CONFIRMATION surgeon’s preferred power setting for various
OF GOOD DISPERSIVE ELECTRODE procedures will expedite subsequent pre-op
APPLICATION. QUALIFIED setup.
PERSONNEL SHOULD MAKE THE
FINAL DECISION ON PROPER 2.6 Operation
DISPERSIVE ELECTRODE PLACEMENT. WARNING: ENSURE THAT THE
9. The ESU powers up to the last settings at the FOOTSWITCHES ARE NOT
time the ESU was last activated. INADVERTENTLY DEPRESSED IN ORDER
Note: Power up to “0” setting is a configura- TO PREVENT ACCESSORIES FROM BEING
tion option that may be selected by a Hospital UNINTENTIONALLY ACTIVATED. PLACE
Qualified Biomedical Technician. Verify that FOOTSWITCHES IN LOCATIONS THAT
the ESU is properly adjusted with the desired NECESSITATE DELIBERATE ACTION IN
mode selected. Adjust the settings as needed. ORDER TO ACTIVATE THE FOOTSWITCH.
The ESU is now ready for operation. USE CAUTION WHEN SELECTING THE
CORRECT FOOTSWITCH TO ACTIVATE.
10. Set the Monopolar Cut Mode to Pure for
cutting or Blend mode for cutting with Activate the electrosurgical unit in the desired
hemostasis. operating mode by depressing the appropriate
treadle of the footswitch or switch of a hand-
11. Set the Monopolar Coag Mode to controlled accessory. Adjust the corresponding
STANDARD to provide a greater degree of power setting until the desired surgical effects are
desiccation (i.e., greater arcing) or to SPRAY obtained.
for non-contact fulguration.
Power setting changes are limited when the ESU
12. Scroll to BIPOLAR MACRO for nor- is activated to the greater of 10 watts or 25% of
mal bipolar tissue desiccation or scroll to the dial setting upon initiation of activation. The
BIPOLAR MICRO for delicate bipolar tissue power setting will be displayed on the digital dis-
desiccation with low voltage. play for each mode.
13. Adjust the CUT, COAG, and BIPOLAR The surgical effects obtained are dependent on a
power settings to the desired levels in the fol- number of factors including waveform, electrode
lowing manner: size, electrode geometry, power level and surgical
• To increase or decrease the power setting technique. The size and geometry of monopolar
one step, momentarily press and release electrodes are significant in that a large electrode,
the desired CUT, COAG, or BIPOLAR absent of sharp features (e.g., a ball electrode) will
Power Adjustment Key. The power set- have no tendency to cut, regardless of the output
ting will increase one step and a short power level. Conversely, a small, sharp electrode,
tone will sound. such as a needle or wire loop, will be likely to cut
• To increase or decrease the power set- simply from mechanical pressure at conservative
ting a number of steps, press and hold power settings. Note that other generator models
the desired CUT, COAG, or BIPOLAR will have different clinical effects than the System
Power Adjustment Key. As the key is 2450, even when the power settings are the same.

2-8
The Bipolar Coagulation waveform is designed to subsequent tests and should be made available to
minimize tissue sticking and popping by limiting the Hospital Qualified Biomedical Technician con-
the output voltage regardless of the power set- ducting the tests.
ting. Bipolar hemostasis is more localized than in
monopolar since the tissue grasped between the 2.8 In Case of Difficulty
forceps tines is most affected. This is particularly Several alarm conditions are described in this
desirable in vascular surgery where monopolar section. Since all alarm conditions will disable
current may concentrate in the affected vessel the ESU until the condition causing the alarm is
and result in undesired tissue effects. This easily corrected, with some resulting delay possible, all
controlled localization is also of benefit in plastic alarms are considered low priority.
surgery and neurosurgery.
2.8.1 Dispersive Electrode Alarm
2.7 User Maintenance
Trouble with the dispersive electrode is indicated
2.7.1 General Maintenance Information by red illumination of the Dispersive Electrode
Status / Alarm Indicators. Activation attempts
While the System 2450 has been designed and will result in an audible fault alarm. Replace the
manufactured to high industry standards, it is dispersive electrode if any patient contact has been
recommended that periodic inspection and per- lost.
formance testing be performed by a Hospital
If a dispersive electrode or A.R.M. alarm is sound-
Qualified Biomedical Technician using techniques
ed intraoperatively, physically confirm proper dis-
described in the ConMed System 2450 Service
persive electrode attachment to the patient.
Manual (Catalog Number 60-2454-ENG) to
ensure continued safe and effective operation. 2.8.1.1 Single Dispersive Electrode Alarm
2.7.2 Cleaning If a Single Dispersive Electrode alarm condition
occurs, confirm that a single dispersive electrode
The exterior of the ESU may be cleaned by wip-
is attached to the ESU. Check all dispersive elec-
ing it with a cloth that has been dampened (not
trode cable connections and replace the dispersive
dripping) with a mild detergent or mild disinfect-
electrode or cable if necessary.
ing solution.
2.8.1.2 Dual Dispersive Electrode Alarm
2.7.3 Periodic Inspection
If a Dual Dispersive Electrode alarm condition
The System 2450 should be visually inspected at
occurs, check the Dual Dispersive Electrode
least every six months. This inspection should
Status/Alarm Indicator for clues to the problem:
include checks for:
a) If only the Dual Dispersive Electrode Status/
• Damage to the power cord.
Alarm Indicator flashes red, the resistance is
• Damage to the power plug. too high. This can be caused by inappropriate
• Tightness of the power plug. choice of a site for the dispersive electrode, a
• Proper mating, cleanliness and absence of broken cable or poor connections to the ESU.
damage to the patient connectors. b) If both the Single and Dual Dispersive
• Obvious external or internal damage to the Electrode Status/Alarm indicators flash red in
ESU. unison, the impedance is too low. This condi-
tion can be caused by a short in the cable, a
• Accumulation of lint or debris within the
short between the two pads on the dispersive
ESU or heatsink.
electrode, or some fault within the ESU.
2.7.4 Periodic Performance Testing Replace the dispersive electrode while ensur-
ing the dispersive electrode makes contact
The System 2450 should be performance tested
only with the patient.
by a Hospital Qualified Biomedical Technician at
least every year. Each ESU is supplied with a seri-
alized Product Test Data Sheet, which tabulates
the results of the factory tests performed on the
ESU. This data may be used as a reference for

2-9
2.8.2 Acc Codes
Acc Codes are most often caused by faults in accessories connected to the ESU. The fault can often be cor-
rected in the operating room without a service call. The following list gives the meaning of each code. For
each code, check the indicated accessory for proper operation. If the fault persists, unplug the accessory, turn
the ESU off and then turn the ESU back on. If the fault is still present, call a Hospital Qualified Biomedical
Technician for assistance.
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 LK Left Hand Monopolar Accessory Replace hand controlled accessory.
Shorted
Acc rK Right Hand Monopolar Replace hand controlled accessory.
Accessory Shorted
Acc bP Bipolar Accessory Shorted Replace bipolar accessory.
Acc [P Control Panel Key Stuck Ensure no control panel keys are depressed on power-up.
Acc bP dA Monopolar Current Flows Release activation button for 3 seconds.
through Bipolar Output

2.8.3 Err Codes

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

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