Megadyne Mega Power Electrosurgical Generator Service Manual

Electrosurgical Generator
SERVICE MANUAL
©Copyright 2008. All rights reserved
1
Service Manual Part # 3000106-01 Rev -D 2008-05-12
The Mega Power Electrosurgical Generator is manufactured in the United States by:
Megadyne Medical Products, Inc.
11506 South State Street
Draper, UT 84020 USA
Phone: 801-576-9669
800-747-6110 (U.S.A. only)
EC REP
Quality First International Limited
20 Eversley Road, Bexhill-on-Sea
East Sussex, TN40 1HE
United Kingdom
©2008 Megadyne Medical Products. All rights reserved.
Megadyne is a registered trademark of Megadyne Medical Products.
Mega Power™ is a trademark of Megadyne Medical Products.
Mega Power Patent numbers: D491,666 D491,667 Mega 2000 is a registered trademark of
Megadyne Medical Products
2
Table of Contents
1. Preface and Service Center Information ………..……………………………...…....1
2. Limited Warranty ……………………………………………..…………………………2
3. Introduction and General Description……………………………………….………...3
4. List of Assemblies……………………………………………………………………….3
5. Warnings…………………………………………………………………………………4
6. Cautions………………………………………………………………………………….5
7. Symbols…………………………………………………………………………………..6
8. Operating Instructions………………………………………………………………… 7
9. Front Panel Controls, Indicators, and Receptacles………………………………..11
Power Switch
Cut Modes:
ACE, Pure Cut, Blend………………..……………..12
Coag Modes:
Standard, Spray, Coag w/ Cut...…………….…….13
Bipolar Mode:
Standard, Macro ……………. ………...…………...14
Bipolar Current Monitor……………………………………………..……….15
Bipolar and Return Patient Return Electrodes and Alarm………………..16
10. Rear Panel Controls, Indicators, and Receptacles………………………………...17
Volume Control, Footswitch connections, Power Cord Connection
Grounding Lug, Fuse Box
11. Calibration Check ……………………………………………………………………18
12. Troubleshooting/Error Codes…………………………………………………………21
13. Monitor Interference…………………………………………………...………………22
14. Error Codes……………………...……………………………………………………..23
15. Technical Specifications Safety Compliance……………………………...………..25
16. Output Power Characteristics………………………………………………………...26
17. Declaration of Electromagnetic Emissions………………………………………….28
18. Approved Accessories……..………………………………………………………….29
19. Power Curve Graphs………………………………………………………………….30
20. Printed Circuit Board Replacement Procedures…………………………...………40
21. Parts List………………………………………………………………………………..55
22. Glossary………………………………………………………………………………..56
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23. Appendix…………………………………………………………………………. …...58
Safety Compliance
Applicable Particular Requirements
Electromagnetic Compliance
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Preface
This service manual is for use only by qualified and trained personnel. It is intended for
servicing the Megadyne Mega Power Electrosurgical Generator only. For clinical use of
this system, please refer to the Mega Power User’s Manual.
Service Centers/Shipping Instructions
Maintenance/Service
It is recommended that maintenance calibration testing be performed at annual intervals.
Refer to the calibration testing section in this manual for details.
In addition to calibration testing routinely inspect the power cord, footswitch cables, and
connectors for any signs of damage. Replace damaged cords and/or connectors immediately.
Should your Mega Power Electrosurgical Generator require service or repair, please
contact Megadyne’s Customer Service department to obtain a Returned Goods
Authorization (RGA) number. Return the generator in its original packaging if possible
with the RGA number written on the address label to:
MEGADYNE Medical Products, Inc.
11506 South State Street
Draper, UT 84020
USA
Phone:
Fax:
1
801-576-9669/ 800-747-6110 (U.S.A. only)
801-576-9698
Limited Warranty
For the periods and the conditions specified below, Megadyne warrants to the original
purchaser that the Mega Power Electrosurgical Generator will perform to our published
specifications when used and maintained in accordance with our written instructions.
The Mega Power Electrosurgical Generator is warranted to be free of defects under
normal use and maintenance for two years from the date of purchase. Megadyne will, at
its option, repair or replace the defective product without charge, using new or
remanufactured parts. Megadyne reserves the right to make a repair in its factory, at any
authorized repair facility, or at the purchaser’s premises.
An unauthorized repair of the Mega Power Electrosurgical Generator will void this
warranty. In addition, the warranty is null and void if the Mega Power Electrosurgical
Generator is used other than is specified in the Operator’s Manual. Without limitation,
the warranty does not cover damage caused by customer misuse of the Mega Power
Electrosurgical Generator.
THIS WARRANTY IS IN LIEU OF ANY OTHER WARRANTIES EXPRESSED OR
IMPLIED, AND ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE IS EXPRESSLY DISCLAIMED. Purchaser’s exclusive
remedy for any failure of the Mega Power Electrosurgical Generator is as provided in
this Limited Warranty. In no event shall Megadyne be liable for any special, incidental,
consequential, indirect or other similar damages arising from break of warranty, break of
contract, negligence or any other legal theory.
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Introduction and General Description
The Megadyne Mega Power Electrosurgical Generator is designed to produce
radio frequency (RF) current for cutting and coagulation during surgical
procedures. It is an isolated output generator.
This manual describes the attributes and specifications of the generator,
describes the internal workings, and provides a guide to the procedures
necessary for calibrating, testing and servicing the unit. For reasons of
personnel safety and continuing reliability, the generator should not be operated,
calibrated, tested, or internally examined by anyone except trained technicians
who are skilled in the operation and service of medical electronics equipment.
Component-level electronic repair is restricted to Megadyne authorized
personnel.
List of Assemblies
The MEGA POWER generator contains the following subassemblies:
• Front Panel
o
o
o
o
3
Control switch overlay
Indicators
Display Printed Circuit Board
Power switch
•
Rear Panel
o Footswitch receptacles
o Volume control
o Power entry module
o Grounding lug
o RS232C port for system control and diagnostics
•
Internal assemblies
o Power Factor Printed Circuit Board
o Microcontroller Printed Circuit Board
o Footswitch Printed Circuit Board
o Main Printed Circuit Board
High Voltage Power Supply
RF Output
Heatsink Assemblies
Low Voltage Power Supply
Safety Circuits
Fan Assembly
Warnings
The warnings given below pertain to testing, calibration, and servicing of
the generator. The service technician should also be aware of the
warnings given in the Operators’ Manual for clinical use of the generator.
4
•
For operation of the generator, connect the power to a properly grounded
receptacle. Do not use a power plug adapter.
•
Accessories connected to the generator are sources of high voltage, high current,
and high frequency electricity. Touching the non-insulated portion of these
accessories or any conductive surfaces that come in contact with these
accessories during activation may result in serious injury.
•
Turn off and unplug the generator prior to cleaning. Rubbing a cleaning cloth over
the front panel may inadvertently activate the pressure-sensitive switches, thus
turning the generator on or changing the power or mode settings.
•
Disconnect the power cord and wait at least five minutes before performing any
procedures that require removal of the outer shell, or replacement of parts or
boards to allow discharge of power supply components.
•
When testing, calibrating, or troubleshooting with the shell off, be aware that
potentially lethal AC, and DC voltages may be present on some components and
exposed metal surfaces. These constitute a serious shock hazard. Do not touch
any of these surfaces. Use non-conductive tools and isolated or high impedance
test probes with high voltage insulated handles.
•
Do not wear ground straps when power is on.
•
When testing, calibrating, or troubleshooting with the outer shell and fan assembly
off, be aware that high voltage RF is present on many of the conductive surfaces
whenever the generator is activated. These constitute a serious burn hazard.
During activation of the RF output, it is not only unsafe to directly touch exposed
metal surfaces but it is also possible for an arc to form between a conductive
surface and a body part. Keep fingers at least one inch away from any internal
generator parts while the generator is activated.
•
Use the lowest possible power settings to achieve the desired effects.
•
Do not install or activate the generator in the presence of flammable anesthetics or
oxidizing gases such as nitrous oxide (N20) and oxygen.
•
Non-flammable agents should be used for cleaning and disinfection wherever
possible.
•
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives,
should be allowed to evaporate before RF activation.
•
Cautery tips that are activated or hot during calibration or troubleshooting can
cause a fire. Do not place them near or in contact with flammable materials
and substances.
Cautions
The cautions given below pertain to testing, calibration, and servicing of
the generator. The service technician should also be aware of the cautions
given in the user manual for clinical use of the generator
5
•
Read all instructions prior to installation and operation.
•
Use properly grounded AC outlets when connecting the generator power
cord.
•
Do not place containers of fluids on the generator, or allow fluids to spill on
the generator.
•
Do not operate the generator without adequate clearance for ventilation.
Space between the bottom of the feet and the floor of the generator should
be free of obstruction. At least two inches of air should separate the sides,
back, and top of the generator from any ventilation-obstructing surface. Do
not place the generator in a small, non-ventilated location.
•
Connect accessories (e.g. pencil, foot cord, bipolar instruments, return
electrode, etc.) to the proper receptacle using connectors specifically
designed for the intended purpose. Follow the instructions for use provided
by accessory manufacturers.
•
Apparent low power output or failure of the electrosurgical equipment to
function correctly at normal settings may indicate faulty application of the
dispersive electrode or failure of an electrical lead. Do not increase power
output before checking for obvious defects or misapplication.
•
Do not coil electrosurgical accessory cords, and do not wrap electrosurgical
accessory cords around metal objects. This may induce current flow to
unintentional areas causing, shocks, burns,
•
With the fan assembly removed, do not activate the generator for more than
one half hour at full rated power and load. Activating the generator beyond
the recommended Duty Cycle of ten seconds on and thirty seconds off for
long periods of time can cause system overheating.
•
When repairing the generator, follow the static control guidelines for
semiconductors in order to avoid damaging individual components or board
assemblies.
Symbols
Symbol
Description
|
ON (Power)
O
OFF (Power)
Read instructions prior to use
Generator output is floating with respect to ground
Defibrillator proof type CF equipment
Dangerous Voltage
Equipotentiality
Foot Switch
Speaker
Fuse
Return electrode connection
Hand control receptacle
Foot control receptacle
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Operating Instructions
With the generator in the “OFF” position be sure that the power cord is fully inserted into
both the generator receptacle on the back of the generator and into the appropriate
grounded outlet (figure 1). The generator will function in either the 100 or 240 volt
modes depending on the power applied to the generator.
Figure 1.
Foot Controls: If footswitches are to be used for activating the active electrode, attach
the monopolar, and/or bipolar foot controls to their appropriate receptacles while the
generator is in the “off” position (figure 2). If footswitches are not used during the
procedure disconnect the footswitches from their receptacles.
Figure 2.
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Patient Return Electrodes: Install a patient return electrode according to the electrode
manufacturer’s instructions for use. Megadyne recommends the use of the Mega Soft™
family of Reusable Patient Return Electrodes, however, the Mega Power Electrosurgical
Generator is compatible with all approved return electrodes. Insert the return electrode
cable into the proper receptacle (figure 3).
Figure 3.
Figure 3.
8
Active Accessories: The Active Accessories are the monopolar hand switching
pencils, electrodes, monopolar foot cords, and bipolar cords. Megadyne recommends
the use of the Megadyne family of Active Accessories, including E-Z Clean electrodes.
Fully insert the Active Accessories into their appropriate receptacles ensuring that no
metal is exposed (figure 4)
Powering the Generator: Turn on the generator by placing the “ON/OFF” switch into the
“ON” position. Once the generator completes the start-up and self check routines of
approximately 8 seconds, the power displays will show dashed lines.
Power Settings: To recall the last power setting used, press the RECALL key. Power
settings may also be initiated by using the up arrow key when the dashed lines are
displayed on the panel. Power settings may be adjusted by using the up and down
arrow keys.
Figure 4.
Figure 4.
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Modes: Select the proper mode for monopolar “CUT” and “COAG” by depressing the
appropriate mode key (figure 5). The indicator light on that key will illuminate when the
mode has been selected.
Figure 5.
Activating the Generator: Monopolar accessories attached to the monopolar hand
switching receptacles may be activated by depressing either the “CUT” or “COAG” keys
on the pencil, or foot pedals. Depressing either the “CUT” or “COAG” foot pedals will
deliver power to the device attached to that channel. Only one active device may be
plugged into each channel at a time (i.e. either the 3-prong pencil cord, or phone plug
style cord).
Note: Only one monopolar accessory can be activated at a time.
Depressing the single footswitch of the bipolar foot control will activate bipolar
instruments attached to the bipolar receptacles. For bipolar hand switching devices,
closing the tips of the bipolar forceps will engage the switch on the instrument and will
activate the device.
Note: The cut or coag display will become brighter when activated, while the unused
display will dim.
Cleaning: Disconnect the power cord from the wall outlet prior to cleaning the generator.
Use a mild detergent, or disinfectant to clean the generator. Abrasive cleaners will
scratch the displays. Do not allow fluids to drain inside the generator.
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Front Panel Controls, Indicators, and Receptacles
The Mega Power generator is designed as a full-functioning, easy to use electrosurgical
unit for cutting and coagulating tissue (figure 6).
Figure 6.
Information regarding Mega Power functions and descriptions are detailed on the pages
to follow.
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The following descriptions correspond to controls, indicators, and receptacles on the
front panel of the generator shown below (figure 7).
Figure 7.
1.
2.
POWER: The power on/off switch is located in the top left-hand corner of the unit. The
unit is turned “ON” when the ‘|’ is depressed and the light above the switch illuminates.
The generator is turned “OFF” when the ‘o’ is depressed and the light above the switch
is extinguished.
CUT: The cut controls are color coded yellow. The large numerical display indicates the
power setting. The arrow ‘up’ key will increase power settings in one watt increments up
to 40W and in increments of 5W thereafter to a maximum of 300W. The arrow ‘down’
key will decrease power settings in increments of five watts from 300W to 40W and in
one watt increments thereafter.
Selecting the “ACE” key places the generator in the ACE (Advanced Cutting Effect) cut
mode. The ACE mode automatically controls the output power of the generator to
provide the surgeon with a consistent cutting effect. Little hemostasis is achieved in this
mode. In the ACE mode the light on the key will illuminate indicating that this mode is
selected, and the power display will show “ACE”. Power can not be manually adjusted
by using the up and down arrow keys.
Selecting the “PURE” key places the generator function into a standard cutting mode.
The light on the key will illuminate indicating that this mode is selected. The standard
cut, or PURE mode allows the user to manually set desired power which is delivered
during activation. Little hemostasis is achieved when in this mode.
Selecting the “BLEND” key places the generator cut function into a blended cutting
mode. The light on the key will illuminate indicating that it is selected. This is a mix of
the cutting and coagulation waveforms. The maximum power allowed in this mode is 200
W. It provides a cutting effect and a higher level of hemostasis than either the “ACE” or
“PURE” cut modes.
During the case, the last BLEND setting used will remain in memory until the mode or
power setting is changed. Once the generator is turned Off, and On again, depressing
the RECALL button will recall the last mode and power setting used.
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3.
COAG: The coag controls are color coded blue. The large numerical display indicates
the power setting. The arrow ‘up’ key will increase power settings in increments of one
watt up to 40W and in 5W increments thereafter to a maximum of 120W.
The arrow ‘down’ key will decrease power settings in increments of five watts from 120W
to 40W and in one watt increments thereafter.
Selecting the “STANDARD” key places the generator coag function into the desiccation
mode. The light on the key will illuminate indicating that this mode is selected. The
desiccation mode provides hemostasis to tissue that is in contact with the active
electrode and provides diminished cutting effect when compared to cut modes.
Coag with Cut Mode
To achieve more cutting effect in the STANDARD Coag mode, press the Pure Cut and
the Standard Coag buttons simultaneously. This activates a second coag mode (Coag
with Cut) for surgeons desiring a mild cutting effect during coagulation. When this mode
is activated, the Standard Coag button will “blink” on and off. To return to the Standard
Coag mode, simply press the Standard Coag button once, or go to Spray Coag and
back to the Standard Coag mode. The blinking light will turn to a solid light and you will
be returned to the Standard Coag mode. Powering down the system will also return the
Mega Power to the Standard Coag mode. The second Coag mode can easily be
recalled (if it was the last mode used) upon start up by pressing the RECALL key or
simply use the instructions above to activate the mode
Selecting the “SPRAY” key places the generator coag function into the spray, or
fulguration mode. The light on the key will illuminate indicating that this mode is selected.
During the case, the last SPRAY setting used will remain in memory as a convenience to
users when toggling between modes during a case. Once the generator is turned Off,
and On again, depressing the SPRAY mode will change the mode, but not the power
setting for patient safety.
The fulguration mode uses higher peak to peak voltages to allow current to “jump” from
the active electrode through air to the target tissue producing sparks. This provides
hemostasis in a more broad area with less depth of tissue damage when compared to
desiccation. The SPRAY coag mode provides diminished cutting effect when compared
to cut modes.
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4. RECALL: The RECALL key is provided as a convenience to users and recalls the last
mode and the last power setting used after the system is turned on, and the recall button
is pushed. During use, toggling between modes will maintain the last power setting use.
5.
Bipolar: The BIPOLAR controls are color coded blue. The large numerical
display indicates the power setting. The arrow ‘up’ key will increase power
settings in increments of one watt up to 80W. The arrow ‘down’ key will
decrease power settings in increments of one watt.
When the bipolar mode is used the current will flow between the two tips of the
instrument and will desiccate tissue. The bipolar mode can be activated with
either a hand switching device, or with a bipolar footswitch.
The Mega Power offers two bipolar settings, a standard/micro bipolar and a
macro bipolar.
Standard/Micro Bipolar
The Mega Power automatically boots up in the Standard/Micro bipolar setting.
This setting is utilized for the majority of all bipolar cases and delivers a precise
and controlled bipolar effect. The initial voltage is kept low to prevent sparking
and the system maintains a specific power curve to achieve the proper tissue
effect.
Macro Bipolar
Bipolar cases requiring a more rapid onset of power and higher voltage power
output utilize a macro bipolar power curve. To access the Macro bipolar setting,
simultaneously press the Standard and Spray Coag buttons as instructed below.
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6. Mega Power Bipolar Current Meter
The Mega Power Electrosurgical Generator Bipolar macro setting features a Bipolar
Current Meter with both a visual graph and bipolar tone to provide an indication of the
amount of current flow between the tips of the bipolar instrument.
Bipolar Current Meter Tone
The current meter bipolar tone can be activated and deactivated when desired.
To activate the Mega Power current meter bipolar tone, press the “Pure” and
“Blend” keys on the front display panel simultaneously. A single tone will
indicate that the bipolar current meter tone is activated. During use, the bipolar
tone will begin with a rapid tone and reduce to a slower, metered tone as
current flow is diminished.
The bipolar current meter tone is turned off in one of two ways:
1). Press the Pure and Blend keys simultaneously. A tone will indicate the
current meter bipolar tone has been disabled.
2). Or, simply turn the main power switch off on the front panel.
The Mega Power bipolar current meter tone will need to be turned on as
instructed above each time the unit is powered on if the tone is desired during
the case.
Bipolar Visual Indicator
The visual indicator will appear automatically when bipolar is in use.
As tissue becomes desiccated it becomes more resistive and less current
flows. Non-desiccated tissue will allow relatively high current flows and will
illuminate all, or most of the green lights on the bar graph. Desiccated tissue
will restrict current flow, reducing the number of lights illuminated on the bar
graph.
7.
Hand switching Accessory Receptacles: The two monopolar hand switching
receptacles are designed to accept standard three-prong active accessory
devices (e.g. an electrosurgical pencil). Either receptacle may be used.
Note: Only one monopolar accessory can be activated at a time.
8.
15
Foot switching Accessory Receptacle: The Foot switching accessory
receptacle on the front of the generator accepts most, 8 mm diameter male style
phone plug style connector from active accessory cords. Power is delivered to
this receptacle when the monopolar footswitch is attached to the appropriate
receptacle on the back of the generator and is depressed by the operator.
Note: Only one monopolar accessory can be activated at a time.
9.
Bipolar Receptacle: The bipolar receptacle can accept either a foot switching
accessory or a hand switching accessory. A foot switching instrument requires
the two large connectors to be inserted into the two mating receptacles. A hand
switching instrument uses an additional male pin on the molded connector which
is inserted into the smaller mating receptacle. Note: Bipolar and monopolar
accessories may not be activated simultaneously.
10.
Patient Return Electrode Receptacle: This receptacle accepts both single
plate and split plate return electrodes.
Megadyne recommends use of the Mega Soft Reusable Patient Return Electrode
family of products with the Mega Power electrosurgical generator.
11.
Patient Return Electrode Alarm:
When the generator is turned “ON” with nothing inserted into the Patient Return
Electrode Receptacle, the pad alarm will be illuminated “red” and the alarm will
sound. When a single plate pad is plugged into the receptacle with a sufficient
connection the alarm light will turn “green”.
When a monitoring, or split pad is plugged into the patient return electrode
receptacle the generator performs a test to insure that the pad is properly
attached to the patient. When the pad is properly installed the alarm icon will be
illuminated “green”. If excessive impedance is detected in the split pad or the
impedance increases by more than 30% from the initial measured value, the
alarm will sound and the alarm symbol will be illuminated “red”.
Megadyne recommends use of the Mega Soft Reusable Patient Return Electrode
family of products with the Mega Power electrosurgical generator.
Additional information on the Patient Return Electrode Alarm can be found in the
Troubleshooting Section of this Manual.
16
Rear Panel Controls, Indicators, and Receptacles
The following descriptions correspond to controls, indicators, and receptacles on the
back panel of the generator shown below.
Figure 8.
1.
Volume Control: The volume level is preset at the factory for all alarms. Volume
control for Cut and Coag tones may be increased by turning the knob in a
clockwise direction, and decreased by turning the knob in a counter-clockwise
direction.
2.
Monopolar Footswitch Connector: A Megadyne two pedal footswitch is
connected by inserting the keyed connector into the proper receptacles and
tightening the threaded collar. The Monopolar A footswitch will activate
accessories attached to the A receptacles on the front of the generator. The B
footswitch will activate accessories in the B receptacles on the front of the
generator.
3.
Bipolar Footswitch Connector: A Megadyne one pedal footswitch is connected
by inserting the keyed connector into the proper receptacle and tightening the
threaded collar.
4.
Power Cord Connector: The hospital grade 3-prong power cord supplied with the
generator is inserted here to provide power to the unit.
5.
Grounding Lug: The grounding lug is provided for additional grounding of the
chassis when required.
6.
Fuse Box: The fuse box can be accessed by using a small flat instrument to
open the drawer and pulling the receptacle towards you. If the fuse has been
damaged replace with the proper size fuse (two each F10.0/250V).
17
7.
Bar Code and Serial Number Plate: The unique serial number is listed on the
plate with a corresponding bar code (figure 9).
Figure 9
Calibration Check
Active outputs
This test requires an ESU analyzer and test leads for connection to generator.
This test can also be performed with fixed loads and a current Loop. All
equipment used must be able to measure true RMS.
1.
Connect the Mega Power monopolar A output to the ESU analyzer. Short
the two leads from the return electrode and connect them to the ESU
analyzer.
2.
Set the Mega Power to the PURE CUT @ 20 watts, and set the ESU analyzer
to 300 ohms.
3.
Activate the Mega Power using the footswitch on monopolar A. Verify an
audible tone while the ESU is activated.
4.
Activate the Mega Power and Verify the output power is 20 Watts +/- 4
watts using the ESU analyzer.
5.
Change the power setting on the Mega Power to 300 watts, activate the
Mega Power and Verify the output power is 300 Watts +/- 60 watts using
the ESU analyzer
6.
Set the Mega Power to the STANDARD COAG @ 20 watts, and set the
ESU analyzer to 500 ohms.
18
7.
Activate the Mega Power using the footswitch on monopolar A. Verify and
an audible tone while the ESU is activated.
8.
Activate the Mega Power and Verify the output power is 20 Watts +/- 4
watts using the ESU analyzer.
9.
Change the power setting on the Mega Power to 120 watts, activate the
Mega Power and Verify the output power is 120 Watts +/- 24 watts using
the ESU analyzer.
10.
Disconnect the Mega Power monopolar A from the ESU analyzer and
connect the Bipolar output to the ESU analyzer.
11.
Set the Mega Power Bipolar to 10 watts, and set the ESU analyzer to 100
ohms.
11.
Activate the Mega Power using the bipolar footswitch. Verify and an
audible tone while the ESU is activated.
12.
Activate the Mega Power and Verify the output power is 10 Watts +/- 2
watts using the ESU analyzer.
13.
Change the power setting on the Mega Power to 80 watts, activate the
Mega Power and Verify the output power is 80 Watts +/- 16 watts using
the ESU analyzer.
14.
Both footswitch monopolar A & B, and hand activation monopolar A & B
should be tested.
Contact Quality Monitoring (CQM) Test.
This test requires test leads to connect to the CQM receptacle, fixed load
resistors and a variable load resistor.
15.
Turn on the Mega Power ESU, the alarm should be red.
16.
Attach a 50 ohm load across the two wires of the test lead. Plug the CQM
Test lead into the Patient Return Receptacle. The alarm light should turn
green.
17.
Unplug the CQM Test lead from the ESU, the alarm should sound and the
light should turn red.
18.
Attach a 150 ohm load across the two wires of the test lead. Plug the CQM
Test lead into the Patient Return Receptacle. The alarm light should
remain red.
19.
Unplug the CQM Test lead from the ESU.
20.
Attach a variable resistor set at 50 ohms across the two wires of the CQM
test lead. Plug the CQM Test lead into the Patient Return Receptacle. The
light should turn green.
19
21.
Adjust the variable resistor to increase the resistance until the alarm
sounds and the light turns red. Read the variable resistor, it should be
between 58 and 72 ohms.
Megadyne recommends a yearly calibration check of the Mega Power Electrosurgical
Generator. If your Mega Power is found to be out of calibration, please send your
system directly to Megadyne for calibration. Contact Megadyne customer service to
obtain an RGA number and shipping instructions prior to sending the Mega Power in for
calibration.
Megadyne Medical Products, Inc.
11506 South State Street
Draper, UT 84020 USA
Phone: 801-576-9669
800-747-6110 (U.S.A. only)
20
Troubleshooting/Error Codes
Troubleshooting - follow the steps in the order listed for the appropriate problem.
No output power:
1. Check that the generator power switch is in the “on” position.
2. Insure the generator is plugged into a grounded, functioning outlet and that the
power cord is securely attached to the receptacle at the rear of the generator.
3. Check the cables and connections to insure that they are intact and securely
connected.
4. Insure the patient return electrode is properly installed and connected to the
generator. If the patient return electrode alarm light stays illuminated red, see
Patient Return Electrode Alarm Stays On section.
5. Check that the active accessories are attached.
6. Check to see if the unit is in the “Standby” mode (dashed lines in display) or if the
power setting is too low. Adjust the power accordingly.
7. Turn the generator to the “Off” position and then back to the “On” position.
8. Replace the accessory devices (i.e. pencil, or footswitch).
9. Check the fuse and replace it if necessary.
10. If the problem is not corrected with the above steps, use a backup generator and
return the unit for service.
Diminished Power Output:
1. Check all accessories for proper set-up and installation.
Patient Return Electrode Alarm Stays On:
1. Check the return electrode cables to insure that they are securely attached to the
pad and generator.
2. Make sure “sticky” pads are securely attached to the patient over a good
muscular, vascular area.
3. If the patient return electrode alarm light remains illuminated red, replace the
return electrode and/or return electrode cable.
4. Turn the generator to the “Off” position and then back to the “On” position.
5. If the alarm condition cannot be immediately corrected use a backup generator.
Greater than Expected Neuromuscular Stimulation:
1. Discontinue use of active accessories.
2. Check all connections for secure fit before continuing use of the generator.
3. Decrease the power setting or change to STANDARD COAG from SPRAY
COAG as relevant.
4. If neuromuscular stimulation continues replace the generator with a backup unit.
5. Have qualified service personnel test the generator for abnormal low frequency
current leakage.
6. If excessive low frequency current leakage is detected return for service.
21
Monitor Interference:
Monitor interference can be an artifact of Electrosurgery. Steps to minimize interference
are as follows:
1. Insure that the ECG electrode is well attached to the patient through proper skin
preparation prior to electrode placement.
2. Insure the electrosurgical cables (active and return) do not cross the cables of
the affected equipment.
3. Plug the affected equipment into a separate power outlet.
4. Use the lowest possible power setting to achieve the desired effect.
5. Interference is usually greatest in the SPRAY COAG mode; it can be reduced by
using a lower voltage mode such as STANDARD COAG.
6. Check all connections to the generator, patient return electrode, and accessories.
7. Some manufacturers of ECG electrodes offer RF (radio frequency) choke filters
for use in the monitor leads. These filters reduce interference while the
generator is activated. RF filters minimize the potential for an electrosurgical
burn at the site of the monitor electrode.
22
Error Codes
The Mega Power is designed to assist the user in identifying failure modes. When
specific conditions are met an error code will be shown in the large displays.
If any of the following errors are displayed and are not cleared by turning the system off
then on, record the error displayed and call Megadyne Customer Service at
1-800-747-6110 (US only) (International: 1-801-576-9698).
Error
Code
Description
Explanation
201
Communication
Error
Internal communications between internal micro controllers has failed.
202
Watchdog Error
Internal Watchdog microcontroller has detected an error and has shut the
system down for safety reasons.
203
Dosage Error
The Master microcontroller has detected an excessive amount of power
consumption compared with the RF output power being delivered.
204
Relay Error
One or more relays have failed the relay diagnostic test.
205
Activation Error
One or more of the foot switches or hand switches were in the active state
during power up.
206
CQM Error
An error was detected in the CQM Network during the Power On Self Test
(POST).
207
Front Panel Button
Press Error
A button press was detected during POST, this condition is not permitted.
208
Active Measurement
Diagnostics Error B+
An error was detected in the B+ Voltage sense network during Power On
Self Test (POST).
209
PFC Shutdown
The internal power supply has reached an overload condition and has
shutdown. The unit may be reset by turning off the power if the overload
condition has cleared, such as an over temperature condition.
210
Calibration
Constants
Checksum Error
The Master Microcontroller reads the calibration constants and the
checksum from EEPROM. If the values do not match an error is displayed.
211
WD CQM Error
The Watchdog has detected a CQM Error.
212
CQM Test Error
The WD has detected an error in the CQM Network during the Power On
Self Test (POST).
213
WD Dosage Error
The Watchdog Microcontroller has detected an excessive amount of power
consumption compared with the RF output power being delivered.
23
214
Primary Relay
Control Error
The Watchdog has detected the inappropriate activation of the Primary
Relay.
215
MP1 Relay Control
Error
The Watchdog Microcontroller has detected inappropriate activation of the
MP1 Relay.
216
MP2 Relay Control
Error
The Watchdog Microcontroller has detected inappropriate activation of the
MP2 Relay.
217
Secondary Relay
Control Error
The Watchdog Microcontroller detected a failure of the Secondary Relay.
218
Frequency Error
The Watchdog Microcontroller has detected the incorrect output waveform.
219
Power Control Error
The Watchdog Microcontroller has detected the incorrect power setting on
the HVPS.
220
Active Measurement
Diagnostics Error I+
An error was detected in the I+ current sense network during Power On
Self Test (POST).
221
Active Measurement
Diagnostics Error
VSV
An error was detected in the voltage sense network (VSV) during Power
On Self Test (POST).
222
Idle State Feedback
Error
The analog signal levels are above the specified levels during an idle state
condition.
223
WD_Primary Relay
Sense Error
The Watchdog Microcontroller detected an error in the Primary Relay.
224
WD MP1 Relay
Sense Error
The Watchdog Microcontroller detected an error in the MP1 Relay.
225
WD MP2 Relay
Sense Error
The Watchdog Microcontroller detected an error in the MP2 Relay.
226
WD Secondary
Relay Sense Error
The Watchdog Microcontroller detected an error in the Secondary Relay.
227
Master Primary
Relay Sense Error
The Master Microcontroller detected an error in the Primary Relay.
228
Master MP1 Relay
Sense Error
The Master Microcontroller detected an error in the Primary Relay.
229
Master MP2 Relay
Sense Error
The Master Microcontroller detected an error in the MP2 Relay.
230
Master Secondary
Relay Sense Error
The Master Microcontroller detected an error in the Secondary Relay.
24
Technical Specifications
General Equipment Specifications
Equipment Classification
Equipment Type
Degree of protection against ingress of water
Patient Circuit
Cooling
Physical Characteristics
Width
Depth
Height
Weight
IEC 60601-1 Class I
IEC 60601-1 Type CF
Meets ANSI/AAMI HF-18,
UL 60601-1 1st Ed.,
IEC 60601-2-2
Isolated from Earth Ground
Natural Convection,
Modulated Internal Fans
40.5 cm (15.9 inches)
40.5 cm (15.9 inches)
20 cm (7.9 inches)
8.65 kg (19 lbs)
Operating Environment
The Mega Power generator is designed and tested to operate within the following
environmental parameters.
Temperature Range:
+10°C (+50°F) to +40°C (+104°F)
Humidity Range:
15% to 75% Non-condensing
Atmospheric Pressure:
700 hPA (10.2 psi) to 1060 hPA (15.37 psi)
Warm-up requirements
If the Mega Power is stored outside of the above range, allow the unit to stabilize at
room temperature for a minimum of one hour before use.
Storage Environment
The Mega Power generator is designed and tested for storage within the following
environmental parameters.
Temperature Range:
-40°C (-40°F) to +70°C (+158°F)
Humidity Range:
10% to 100 %, Condensing
Atmospheric Pressure:
500 hPA (7.25 psi) to 1060 hPA (15.37 psi)
Audio frequencies
ACE Cut, Pure CUT and Blend
Standard Coag and Spray Coag
Bipolar
Alarms
Power Limit (One beep)
Errors (Two beeps)
CQM (Three Beeps)
840 Hz ± 10%
520 Hz ± 10%
480 Hz ± 10%
1980 Hz ± 10%
1980 Hz ± 10%
2550 Hz ± 10%
The volume of the CUT, COAG and BIPOLAR active signals can be adjusted up and
down. They have a minimum volume of 40 dB at a distance of one meter. The alarm
volume is fixed to exceed 65 dB at a distance of one meter per the requirements of
ANSI/AAMI HF-18.
25
Type and Rating of Fuses: 2 each F10.0/250V
Electrical properties
Nominal Operating Voltage: 100 – 240 VAC
Nominal Operating Frequency:
50-60 Hz
Output Power Variation
Output variation as a function of input variation
<5%
Output Power Characteristics
Mode
Power
(Watts)
Output
Rated
Tolerance Load
Ohms
Maximum
Open Circuit
Voltage
Operating
Frequency
kHz
Crest Factor
Nominal @
Rated Load
Vp-p
Monopolar CUT
ACE Cut
150
20%
200
1500
400
1.4
Pure Cut
300
20%
300
3000
400
1.4
Blend
200
20%
300
4000
400
3.0
Spray
120
20%
500
7200
400
8.0
Standard
120
20%
500
5800
400
7.4
Coag with Cut
120
20%
500
4000
400
6.0
Standard/Micro
80
20%
100
760
400
1.4
Macro
80
20%
100
760
400
1.4
Monopolar COAG
Bipolar
Low Frequency (50 - 60 Hz) Leakage Current
NC
SFC
Earth Leakage Current general
< 300 µA
< 1.0 mA
Enclosure
< 100 µA
< 500 µA
Patient Leakage Current
< 10 µA
< 50 µA
Patient Auxiliary Current d.c.
<
10µA
< 50 µA
Patient Auxiliary Current a.c.
< 100µA
< 500 µA
High Frequency (RF) Leakage Current
Monopolar Modes (all settings at the maximum)
Patient Return to Ground
<150mA
Active to Ground
<150mA
Bipolar Mode (Maximum setting)
Each Lead to Ground
26
< 63mA
Power Consumption
Maximum mains current
Idle
Cut
Coag
Bipolar
Power Factor Correction
Idle
Cut
Coag
Bipolar
100-120 VAC
0.3 A
5.0 A
2.4 A
1.3 A
0.85
0.99
0.98
0.95
220-240 VAC
0.15 A
2.5 A
1.2 A
0.65 A
0.70
0.98
0.97
0.93
Power Cord
Hospital Grade three prong connector
Power Duty Cycle
Under maximum power conditions, the Mega Power generator is designed to operate
safely with activation times of 10 seconds on, 30 seconds off for one hour.
Audio Volume
The MEGA POWER system is designed to generate the following audio levels:
Mode
Frequency
Volume Adjustability
Pure Cut
840 Hz ± 10 %
40 to 65 dB
ACE
840 Hz ± 10 %
40 to 65 dB
Blend
840 Hz ± 10 %
40 to 65 dB
Coag Standard
520 Hz ± 10 %
40 to 65 dB
Coag Spray
520 Hz ± 10 %
40 to 65 dB
Bipolar
480 Hz ± 10 %
40 to 65 dB
Bipolar Monitor
800 to 1600 Hz ± 10 %
40 to 65 db
Power Limit Alarm(One beep)
1980 Hz ± 10 %
> 65 dB non-adjustable
Errors
(Two beeps)
1980 Hz ± 10 %
> 65 dB non-adjustable
CQM (Three Beeps)
2550 Hz ± 10 %
> 65 dB non-adjustable
Contact Quality Monitor
Megadyne recommends the use of the Mega 2000 Patient Return Electrode. Due to the
built-in safety (self current limiting) of the Megadyne Mega 2000 patient return electrode,
the CQM limitation is no longer essential.
If a disposable split pad is used with the Mega Power, the system will perform as follows:
Acceptable Resistance Range (thermal safety).
Return electrode: 5 to 135 ohms or up to 30% increase in the initial measured contact
resistance between the return pad and the patient.
CQM Alarm Activation (thermal safety)
When the measured resistance exceeds the aforementioned parameters, the CQM
indicator will flash red, an alarm tone will sound twice, and the RF output will be disabled.
The Mega Power system will remain in this mode until the unsafe condition is corrected.
RS232C Port
This communication port is located in the back panel behind a removable plate. The
RS232 Port is used for calibration. See the calibration section in the Service Manual for
details.
27
Declaration for Electromagnetic Emissions
The Mega Power is intended for use in the electromagnetic environment specified below. The user of the
Mega Power should assure that the Mega Power is used in such environment.
RF Emissions CISPR 11
Group 2
The Mega Power must emit electromagnetic
energy in order to perform its intended function.
RF Emissions CISPR 11
Harmonic Emissions IEC 61000-3-2
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Class A
Class A
Complies
The Mega Power is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Declaration for Electromagnetic Immunity
The Mega Power is intended for use in the electromagnetic environment specified below. The user of the Mega
Power should assure that the Mega Power is used in such environment.
Immunity Test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines.
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field.
IEC 61000-4-8
IEC 60601 Test
Level
± 6kv contact
± 8kv air
Compliance
Level
Full compliance
Electromagnetic environment guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
± 2kv for power
supply lines
± 1kv for
input/output lines
± 1kv differential
mode
± 2kv common
mode
<5% Ut (>95% dip in
Ut) for 0.5 cycle
40% Ut (60% dip in
Ut) for 5 cycles
70% Ut (30% dip in
Ut for 25 cycles
<5% Ut (>95% dip in
Ut for 5 sec
Full compliance
Mains power quality should be that of a
typical commercial or hospital
environment.
Full compliance
Mains power quality should be that of a
typical commercial or hospital
environment.
Full compliance
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Mega
Power requires continued operations
during power mains interruptions, it is
recommended that the Mega Power be
powered from an uninterruptible power
supply or a battery.
3 A/m
Full compliance
Power frequency magnetic fields should
be at levels characteristic of a typical
commercial or hospital environment
Disposal
The equipment can be disposed of at the end of its useful life as with normal electronic scrap.
Notice: Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components.
28
Approved Accessories
Megadyne recommends use of the following Megadyne accessory devices with the Mega
Power Electrosurgical Generator. These accessory devices have been tested and are
approved for use at the peak voltages listed in this manual.
The user is responsible to insure that any other accessories used with the Mega Power
ESU are rated for the maximum peak output voltages (reference to diagrams included
herein); set at the intended output control setting in the intended operating mode.
Item Description
Catalog Number
Monopolar Footswitch
1400
Bipolar Footswitch
1450
MEGA Soft Patient Return Electrode
Re-CORDalbe adhesive backed
Patient Return Electrodes.
0800, 0830, M2K-01
0850, 0855, 0870, 0875
E-Z Clean Electrodes
contact MEGADYNE for item numbers
Electrosurgical Pencils with tips
0035, 0035H, 0037, 0037H, 0039, 0039H
Active Electrode Cables and Adapters
0075
Warning: The use of accessories other than those specified above may result in increased
emissions or decreased immunity of the Mega Power Electrosurgical Generator.
29
Power Curve Graphs
Ace Power Curve Graphs
ACE Cut - Output Power vs Load Resistance
160.0
140.0
120.0
Power (W)
100.0
80.0
60.0
40.0
20.0
0.0
0
500
1000
1500
2000
Load Resistance (Ohms)
30
2500
3000
3500
ACE - Power Output vs Power Max
Rl = 300 Ohms
180
160
ACE Output at
Rated Load
140
Power HF Output (W)
120
100
80
60
40
20
0
0
20
40
60
80
100
120
140
150
160
Power HF Maximum
ACE - HF Voltage vs Output Power
700
600
HF Voltage (Vp)
500
400
300
200
100
0
0
25
50
75
Output Power (W)
31
100
125
150
Pure Cut Output Power Graphs
Pure Cut - Output Power vs Load Resistance
300
250
300 W
Power (W)
200
150
150 W
100
50
0
0
500
1000
1500
2000
2500
Load Resistance (Ohms)
Pure Cut - Power Output vs Power Max
Rl = 300 Ohms
350
300
Power HF Output (W)
250
200
150
100
50
0
0
50
100
150
Power HF Maximum (W)
32
200
250
300
Pure Cut - HF Voltage vs Output Power
1600
1400
1000
800
600
400
200
0
0
100
150
200
250
300
Output Power (W)
Blend Output Power Graphs
Blend Cut - Output Power vs Load Resistance
250
200
200 W
150
Power (W)
HF Voltage (Vp)
1200
100
100 W
50
0
0
500
1000
1500
Load Resistance (Ohms)
33
2000
2500
Blend Cut - Power Output vs Power Max
Rl = 300 Ohms
250
Power HF Output (W)
200
150
100
50
0
0
50
100
150
200
Power HF Maximum (W)
Blend Cut - HF Voltage vs Output Power
1800
1600
1400
HF Voltage (Vp)
1200
1000
800
600
400
200
0
0
40
80
120
Output Power (W)
34
160
200
Standard Coagulation Output Power Graphs
Standard Coag and Coag with Cut - Output Power vs Load Resistance
140
120
120 W
Power (W)
100
80
60
60 W
40
20
0
0
500
1000
1500
2000
2500
3000
Load Resistance (Ohms)
Standard Coag and Coag with Cut - Power Output vs Power Max
Rl = 500 Ohms
140
120
Power HF Output (W)
100
80
60
40
20
0
20
40
60
80
Power HF Maximum (W)
35
100
120
Spray Coagulation Output Power Graphs
Spray Coag - Output Power vs Load Resistance
140
120
Power (W)
100
120 W
80
60
60 W
40
20
0
0
500
1000
1500
Load Resistance (Ohms)
36
2000
2500
3000
Spray Coag - Power Output vs Power Max
Rl = 500 Ohms
140
120
Power HF Output (W)
100
80
60
40
20
0
0
20
40
60
80
100
120
Power HF Maximum (W)
Spray Coag - HF Voltage vs Output Power
4000
3500
HF Voltage (Vp)
3000
2500
2000
1500
1000
500
0
0
10
30
60
Output Power (W)
37
90
120
Bipolar Output Power Graphs
Bipolar - Output Power vs Load Resistance
90
80
70
Power (W)
60
50
40
30
20
10
0
0
500
1000
1500
2000
2500
Load Resistance (Ohms)
Bipolar - Power Output vs Power Max
Rl = 100 Ohms
90
80
Power HF Output (W)
70
60
50
40
30
20
10
0
0
10
20
30
40
Power HF Maximum (W)
38
50
60
70
80
Bipolar - HF Voltage vs Output Power
400
350
HF Voltage (Vp)
300
250
200
150
100
50
0
0
10
20
40
Output Power (W)
39
60
80
Printed Circuit Board Replacement Procedures
1.
Serviceable components and assemblies can be replaced by following the
procedures outlined in this section.
•
•
•
•
•
•
•
•
•
•
ESU Cover and Chassis Cover
Fuses, two in the Power Entry Module and one on the Motherboard
Controller Board
Power Conversion Board
Heat sinks (left, center and right heat sinks) and associated heat sink
components
Front Panel Display
Low Voltage Power Supply
Motherboard
Footswitch
Power Entry Module
Warning
Electrical Shock Hazard – To allow stored energy to dissipate after power is
disconnected, wait at least five minutes before replacing parts
Caution
The generator contains electrostatic-sensitive components. When repairing the
generator, work at a static-control workstation. Wear a grounding strap when handling
electrostatic-sensitive components, except when working on an energized generator.
Handle circuit boards by their nonconductive edges. Use an antistatic container for
transport of electrostatic-sensitive components and circuit boards.
2.
For Service Centers and Megadyne trained facilities.
Additional information on assembly replacement is available on Mega Power
Service and Repair Video Instruction 3000146-01. This instruction is in DVD
format and can be viewed by opening InterVideo WinDVD on your personal
computer and inserting the disk into the DVD drive.
40
Equipment required:
• Phillips screwdriver
Step 1 – Remove the ESU Cover and Chassis Cover
Turn off the generator, Disconnect the power cord from the wall receptacle
Remove the five (5) screws that secure the cover (item A) to the chassis. Pull the cover
off of the chassis by pulling the ESU cover horizontally toward the rear of the ESU.
A
Screw
Screw
Screw
Screw
Screw
41
Remove the ESU Cover and Chassis Cover , continued
Remove the chassis cover (item B):
Remove the four (4) screws that secure the Chassis Cover to the Chassis.
Lift the front of the Chassis Cover and remove both wire harness connecters from the
front panel which connect to the Chassis Cover.
Note – Step 1 will be required before proceeding with any of the following steps.
B
Screw
Screw
Screw
Screw
42
Step 2 – Fuse Replacement
Motherboard Fuse Replacement
Remove the fuse (item A) by pulling straight up on the fuse until it’s free of the fuse clip.
Replace with a new fuse by pressing the fuse straight down until the fuse snaps into
place.
A
43
Power Entry Module Fuse Replacement
Remove the fuses in the Power Entry Module by prying open the access drawer (item B)
with a small flat blade screw driver. Replace the fuses in the drawer and return the
drawer to the module.
B
44
Step 3 – Removal/Replacement of the Controller Board
If it is determined in the Troubleshooting Section that the controller board needs
replacing, please follow the instructions below:
Disconnect the display board ribbon cable (item B) from the controller board by
squeezing the sides of the connector (item C) and pulling straight up.
Unlock the controller board from the card guide by pressing the card lock (item D)
toward the rear of the ESU. Carefully slide the controller board straight up through the
card guides to disconnect it from the motherboard. Set the board aside in an antistatic
container for reinstallation.
Repeat steps in reverse order to install Controller board.
B
C
D
A
45
Step 4 – Removal/ Replacement of the Power Conversion Board
If it is determined in the Troubleshooting Section that the power conversion board needs
replacing, please follow the instructions below:
Remove one screw (item A) from associated heat sink .
Unlock the controller board from the card guide by pressing the card lock (item C)
toward the rear of the ESU. Carefully slide the power conversion board (item B) straight
up through the card guides to disconnect if from the motherboard. Set the power
conversion board aside in an antistatic container for reinstallation.
Repeat steps in reverse order to install Power Conversion Board.
C
A
B
46
Step 5 – Removal/Replacement of the Heat Sinks
This step applies to item A, left heatsink and item D, right heatsink. Remove the two (2)
screws through the access holes (items E, see diagram on next page.) located on the
flanking chassis plates attached on each side of the ESU. Remove one (1) screw on the
chassis (item F, see diagram on next page). Pull the heat sink upwards to remove it.
This step applies to item B, center heatsink. Remove item C, low voltage supply
harness, to obtain access to item B. Remove the two screws securing the heat sink
(item B) to the motherboard. Pull the heatsink upwards to remove it.
Repeat steps in reverse order to install Heat sinks.
B
A
47
C
D
F
E
48
Step 6 – Removal/Replacement of the Front Panel Display
Remove the four (4) screws securing the front panel display (item A) to the chassis.
Disconnect the wires (item B) connecting the front panel to the power entry module (item
C) at the power entry module.
Disconnect the wire harness that runs from the front panel to the Power Conversion
Board (PCB) at the Power Conversion board.
Remove the PCB from the front cover by unplugging the ribbon cable (item D) and
removing the six (6) screws holding the PCB to the molded front panel (not shown).
Repeat steps in reverse order to install the front panel display and PCB.
A
D
Screw
Screw
Screw
Screw
B
C
49
Step 7 – Removal/Replacement the Low Voltage Power Supply
Remove the four (4) screws securing the low voltage power supply (item A) to the
chassis.
Repeat steps in reverse order to install the low voltage power supply.
A
Screw
Screw
Screw
50
Screw
Step 8 – Removal/Replacement of the Motherboard
Remove the two (2) high-voltage connector screws and fifteen (15) chassis screws
securing the motherboard (item A) to the chassis.
Pull horizontally towards the front on the high-voltage connector (item B) to
remove the motherboard from the chassis.
HV Screw
Repeat steps in reverse order to install the motherboard.
A
HV Screw
Both Sides
B
51
Step 9 – Removal/Replacement of the footswitch board
Loosen the set screw on the volume knob (item A) and remove the volume knob.
Remove the nut securing the volume control on the other side of the chassis.
Remove six (6) #4-40 screws and two (2) #6-32 screws to remove the footswitch board
(item B. See diagram on next page) from the chassis.
Repeat steps in reverse order to install the footswitch board.
A
52
B
53
Step 10 – Removal/Replacement of the Power Entry Module
Remove the wire connector (item A) at the power entry module (item B).
Remove the two screws that secure the power entry module to the chassis and pull
towards the rear of the chassis until the power entry module is clear of the chassis.
Repeat steps in reverse order to install the power entry module.
B
A
54
Parts List
Description
Center Heatsink Assembly
Mother Board Assembly
High Voltage Connector Assembly
Right Side Heatsink Assembly
Left Side Heatsink Assembly
Front Panel Molded Nosecone w/o PCB
Front Panel Assembly with PCB
Controller PCB
Power conversion PCB
Foot Control PCB
Top cover Assemblyy
Fan (3 x 3 x 5) with Connector
Fan (2.4 x 2.4 x 5) with Connector
Harness, Foot Control to Main PCB
Harness, Controller to Front Panel
Harness, Power, Main to Switch
Harness, Power Switch to PFC
Harness, Power PFC to LV Supply
Harness, Low Voltage Supply to Main
Harness, Line Ground to Chassis
Fiber Optic Cable
Low Voltage Power Supply
AC Power Switch
3 Amp Motherboard Fuse
Line Filter Fuse
Cord, Power, 15'
Screw, Phillips, Pan Head, 4-40 X 1/4
Screw, Phillips, Pan Head, 4-40 X 3/8
Screw, Phillips, Pan Head, 4-40 X 2.0
Screw, Phillips, Flat Head 4-40 X 1/4
Screw, Phillips, Flat Head 6-32 X 3/8
Screw, Phillips, Flat Head 6-32 X 3/8
Screw, Phillips, Flat Head 6-32 X 5/8
Screw, Phillips Pan Head SEMS 6-32 X 3/8
Screw, Phillips Pan Head SEMS 6-32 X 5/8
Screw, Phillips Pan Head SEMS 6-32 X 3/8
Screw, Phillips Pan Head SEMS 4-40 X 5/16
Standoff, Hex .25 X 1.125
Standoff, Hex .25 X 2.25
Module, Power Entry, 10A
Knob, Volume control
55
Part Number
6020089-01
6020088-01
6020090-01
6020091-01
6020092-01
6020093-01
6020094-01
6020095-01
6020096-01
6020097-01
6020098-01
6020099-01
6020100-01
3750009-01
3750010-01
3750011-01
3750012-01
3750013-01
3750014-01
3750015-01
3750019-01
4600012-01
4600038-01
4600040-02
4600039-01
4600034-01
5600006-01
5600006-02
5600006-03
5600007-01
5600007-04
5600007-05
5600007-10
5600008-02
5600008-03
5600008-05
5600008-06
4600031-01
4600028-01
4600014-01
4600037-01
Glossary
Active Electrode
An electrosurgical instrument or accessory that
concentrates the electric current at the surgical site.
Bipolar Electrosurgery
Electrosurgery in which current flows locally
between two electrodes that are positioned around
a segment of tissue to create a surgical effect
(usually desiccation). Current passes from one
electrode, through the desired tissue, to the other
electrode, thus completing the circuit without
entering any other part of the patient’s body.
Capacitive Coupling
The passage of high frequency electrical current
from one conductor to an adjacent conductor, even
though the conductors are separated by air, or
insulation.
Coagulation
The electrosurgical effect that results from heating
due to high current density in the tissue causing
cellular fluid to evaporate. This disrupts the tissue
structure, shrinking the open vessels and creating a
coagulum mass. This combination of tissue
reformation results in hemostasis. A high voltage
waveform is generally used with intermittent
application of current.
Contact Area w/Mega 2000
Return Electrodes
Area of the reusable electrode which bears the
weight of the patient.
Current
The flow of electrons in a circuit measured in
amperes. An ampere is defined as the number of
electrons moving past a given point per second.
The flow of electricity.
Cutting
The electrosurgical effect which results from high
current density in the tissue causing cellular fluid to
convert to steam and burst the cell structure.
Voltage is low and current is high.
Direct Coupling
The condition that occurs when one electrical
conductor (the active electrode) comes into direct
contact with another secondary conductor (tissue,
scopes, graspers). Electrical current will flow from
the first conductor into the secondary one and
energize it.
56
Electrosurgery
The use of high frequency electrical current through
tissue to create a desired clinical effect (cutting or
coagulating).
Electrosurgical Circuit
A closed path through which an electric current is
caused to flow by application of a voltage between
the active and return terminals of an electrosurgical
generator.
Impedance
The opposition to the flow of electric current
through conductors, resistors, capacitors or
inductors, measured in ohms. An ohm is the
voltage differential across a circuit segment which
results from the passage of one ampere of current.
Insulation Failure
The condition that occurs when the insulation
barrier around an electrical conductor is breached.
As a result, current may travel outside the intended
circuit.
Isolated Output
The output of an electrosurgical generator that is
not referenced to earth (ground).
Monopolar Electrosurgery
A surgical procedure that directs current from the
surgical site through the patient’s body and back to
the generator with the use of a patient return
electrode.
Patient Return Electrode
A plate or pad that recovers the therapeutic current
from the patient in a low density format and safely
returns it to the electrosurgical generator. Also
known as dispersive electrode, neutral electrode,
grounding pad, split plate electrode, monitoring
electrode, and gel pad.
Resistance
The opposition to the flow of electric current
through a conductor or resistor, measured in ohms.
Resistance is a special case of impedance.
Return Electrode Contact
Quality Monitoring (RECQM)
A system that actively monitors tissue impedance
between the patient’s body and the patient return
electrode and interrupts the power if the quality of
the contact is compromised.
Voltage
The force that pushes electric current through an
impedance; electromotive force or potential
difference expressed in volts. One volt is the force
necessary to push one ampere through an
impedance of one ohm. It is also the potential
difference created by the passage on one ampere
through an impedance of one ohm.
57
Appendix
Safety Compliance
UL 2601-1, Medical and Dental Equipment, 2nd edition
CAN/CSA-22.2 No. 601.1-M90 Medical Electrical Equipment, General Requirements for
Safety, 2nd edition
IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, 2nd
edition.
IEC 60601-1-4, Safety for Programmable Electronic Systems, 1997
IEC 60529:2001, Degrees of Protection provided by Enclosures
ANSI/AAMI ES-1 1993, Safe current limits for Electromedical Apparatus
Applicable Particular Requirements
IEC 60601-2-2 Particular requirements for the safety of high frequency surgical
equipment, 1998
ANSI/AAMI HF 18:2001 Electrosurgical Devices
Electromagnetic Compliance
EN 55011:1998 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment
Radio Disturbance Characteristics - Limits and Methods of Measurement CISPR
11:1997, Modified
IEC 60601-1-2:2001 Medical Electrical Equipment - Part 1-2: General Requirements for
Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
CISPR 11:1997, Industrial, scientific and medical (ISM) radio- frequency equipment –
Electromagnetic disturbance characteristics – Limits and methods of measurement
FCC 47 CFR Part 18 1998, Industrial, Scientific and Medical Equipment
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