Cusa Excel
Cusa Excel
945103104ILS, Rev. A
Ultrasonic Surgical Aspirator Service Manual
Radionics® MAYFIELD® Auragen™ Ruggles™ CUSA® OSV II® DuraGen Plus® Camino®
Stereotaxy Stabilization Brain Mapping Instruments Tissue Ablation CSF Management Duraplasty NeuroCritical Care
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
Distributed by
Integra LifeSciences Corporation
Plainsboro, NJ 08536, USA
800-997-4868
© 2009 Integra LifeSciences. All rights reserved. Contents of this publication
may not be reproduced in any form without the written permission of Integra.
Patent Information
One or more of the following U.S. patents and corresponding foreign patents
cover the CUSA EXcel system
4634419 4734964 4747820 4827911 4846790
4881761 4921476 4931047 4988334 5015227
5190517 5312329 5421829 5466020 6083191
6214017 6256859 6499358 6602227 6654999
D438952
0086
Organization
We have organized this guide to introduce the safety issues, the system, and its
functions. After safety and the system, the guide gives instructions for unpacking
the system, then describes its components, technical specifications, and theory of
operation. The next sections tell you how to check out, maintain, troubleshoot,
replace parts, and calibrate the system. A schematics supplement includes printed
circuit board (PCB) layouts and schematics.
Caution
Indicates a hazardous situation which, if not avoided, may result in minor or moderate
injury.
Notice
Indicates a hazard which may result in product damage.
Important
Indicates an operating tip or
maintenance suggestion.
Section 2. Introduction
For Your Information 2-1
Overview 2-2
Fragmentation 2-2
Tip Motion 2-2
Cooling 2-2
Irrigation 2-3
Aspiration (Suction) 2-4
Handpieces 2-5
Wide Variety of Tips 2-5
Appendix A. Warranty
Figure 11-19. Removing the suction hose and clamp from the suction control
valve 11-27
Figure 11-20. Removing the suction tube and clamp from the “T” fitting 11-30
Figure 11-21. Pulling the split bushing away from the manifold bracket 11-30
Figure 11-22. Disconnecting cables from the suction pump to the suction pump
controller card 11-31
Figure 11-23. Removing the suction tube and strain relief bushing from the
suction pump and its wires 11-33
Figure 11-24. Removing the suction pump from its bracket mount 11-33
Figure 11-25. Attaching the suction pump motor to its mounting bracket, making
sure to center the pump on the bracket 11-34
Figure 11-26. Removing the cable clamps and screws from the suction pump
controller card 11-36
Figure 11-27. Removing the irrigation pump bezel 11-39
Figure 11-28. Removing the suction pinch valve 11-39
Figure 11-29. Removing the irrigation pump bezel 11-41
Figure 11-30. Removing the irrigation pump head 11-42
Figure 11-31. Disconnecting the irrigation pump gear motor from the control card
11-43
Figure 11-32. Replacing the gear motor/pump head coupler on the motor drive
shaft 11-44
Figure 11-33. Replacing the handpiece flow sensor 11-47
Figure 11-34. Removing the end bell and tubing from the cooling water pump
head 11-50
Figure 11-35. O-rings on cooling water reservoir connectors 11-51
In this section:
• Safety information
• Warnings, Cautions, and Notices, organized by section.
Safety Information
The safe and effective servicing of ultrasonic surgical equipment depends to a
large degree on factors solely under the control of the service person. There is no
substitute for a properly trained and vigilant service staff. It is important that you
read, understand, and follow the procedures supplied with this ultrasonic
equipment.
General
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
Notice
Operating the console outside the specified voltage ranges may cause damage to the
power supply.
Introduction
Caution
Read all warnings, cautions, notices and instructions provided with the CUSA EXcel
system before servicing it.
Read the instructions, warnings, cautions, and notices provided with the CUSA EXcel
handpieces before servicing them.
To avoid injury to surgical personnel, keep fingers away from the suction pinch valve.
Console Components
Caution
To avoid injury to surgical personnel, keep fingers away from the suction pinch valve.
Technical Specifications
Warning
Explosion Hazard Do not use the CUSA EXcel system in the presence of flammable
anesthetics or any potentially explosive or flammable atmosphere.
Caution
To avoid injury to surgical personnel, keep fingers away from the suction pinch valve
while powering the unit on or off, activating vibration, or using fast flush.
Checkout Procedures
Caution
Do not allow the handpiece tip to contact anyone or anything during tip activation.
Notice
To avoid product damage, NEVER hold the handpiece in your hand while using the
torque wrench to tighten or loosen the tip.
Notice
Do not rub, press, or touch any panels with solvents; caustic, corrosive, or abrasive
cleaning or disinfectant compounds; or other materials that could scratch the panels. Do
not use a betadine-based solution; it will cause discoloration.
Do not clean the sterilizer case with abrasives. Product damage will result.
Product damage will result if you do not follow these notices when cleaning the
handpiece:
• Do not immerse the handpiece cable electrical connector in liquid.
• Do not use ultrasonic or automated cleaners.
• Do not use chlorinated substances such as bleach solution.
• Do not clean the handpiece with abrasives such as Ajax, Comet, or steel wool.
Product damage will result if you do not follow these notices when cleaning the Tip
Torquing Set.
• Do not use ultrasonic or automatic washers.
• Do not autoclave.
• Do not use chlorinated substances such as bleach solution.
• Do not clean with abrasives such as Ajax, Comet, or steel wool.
Troubleshooting
Warning
Electric Shock Hazard Do not touch any exposed wiring or conductive surface while
the system is disassembled and energized. Never wear a grounding strap when working
on an energized system.
Electric Shock Hazard Take appropriate precautions (such as the use of isolated tools
and equipment; use of the “one hand rule,” etc.) when taking measurements or
troubleshooting the system.
Do not activate vibration or the CEM handswitching nosecone while using the tip cleaner.
Tip damage, user injury, electrical shock, or any combination of these effects may occur.
Notice
Electrostatic Sensitive Devices This unit contains electrostatic sensitive components.
When repairing the system, work at a static control workstation. Wear a grounding strap
when handling electrostatic sensitive components. Handle circuit boards by their
nonconductive edges. Use an antistatic container for transport of electrostatic sensitive
components and circuit boards.
Replacement Procedures
Warning
Electric Shock Hazard Only trained biomedical engineers and technicians are
authorized to service the CUSA EXcel system.
Electric Shock Hazard Do not touch any exposed wiring or conductive surface while
the CUSA EXcel system is disassembled and energized. Never wear a grounding strap
when working on an energized CUSA system.
Electric Shock Hazard Take appropriate precautions (such as the use of isolated tools
and equipment; use of the “one hand rule,” etc.) when taking measurements or
troubleshooting the CUSA EXcel system.
High Current Hazard Do not touch the ultrasonics PCB heat sink while the
CUSA EXcel system is energized. The heat sink is isolated from ground, and can deliver
very high current, resulting in injury.
Notice
If you plan to connect the handpiece for activation, ensure that an I.V. set is available to
When installing a new power supply, use the same screws and washers removed from the
previous power supply. A too-long screw will damage the power supply.
To avoid product damage, do not remove the jumper cable or the connector at J4.
To avoid product damage, remove the ESD wrist strap before connecting cables to the
Machine Control PCB.
To avoid product damage, when handling the suction pump controller card, do not turn
the three white adjustment dials designated as current limit (R13), max speed (R12), and
min speed (R11).
Calibration
Warning
High Current Hazard Do not touch the ultrasonics PCB heat sink while the
CUSA EXcel system is energized. The heat sink is isolated from ground, and can deliver
very high current, resulting in injury.
Repair Policy
Caution
To prevent the ramp from falling and causing injury, be sure to hold the ramp in the up
position while stapling the corrugated tab that secures it to the crate.
Introduction
2
In this section:
• Overview
• Fragmentation
• Irrigation
• Aspiration (Suction)
• Handpieces
• Wide variety of tips.
Read the instructions, warnings, cautions, and notices provided with the CUSA EXcel
handpieces before servicing them.
This section presents the CUSA EXcel system general information; what it is,
what it does, and (generally) how it works.
Overview
The CUSA EXcel system is an ultrasonic surgical aspirator that allows a surgeon
to remove tissue—selectively and with precise control—from the body. It
performs three functions:
• Fragmentation
• Irrigation
• Aspiration (suction).
All three functions may occur at the same time.
The CUSA EXcel system includes the following components:
• The console:
The console body houses electronics, pumps, and other parts that make the
system work.
The control panel allows the user to control the system.
• The handpiece is the handheld surgical device that actually touches the
patient.
• Accessories include a variety of items; for example, manifold tubing, a large
selection of tips, a tip torquing base and torque wrench, and a sterilizer case.
Fragmentation
Tip Motion
Fragmentation occurs when the vibrating tip interacts with tissue. As the tip
begins to move toward tissue, it accelerates, impacts the tissue, then penetrates
the tissue. The acceleration, impact, and penetration produce a combination of
direct mechanical forces and hydrodynamic pressures that burst cells.
For more information on how the handpiece works, refer to Section 6, Principles
of Operation, in this manual.
Cooling
The high frequency vibration generates heat. To reduce the heat, the CUSA EXcel
system includes a closed, recirculating cooling water system. This system pulls
water from a cooling water reservoir, through a tube in the handpiece cable,
through the handpiece, and through a return tube in the handpiece cable to the
cooling water reservoir. Cooling water flows at 35 to 50 cc/min.
As it passes through the handpiece, the water removes heat. Normal handpiece
temperature, in sustained heavy use, remains at about 40° C (104° F).
Use distilled water for the cooling water system because it does not contain
natural minerals, chemical additives, or organic materials that are present in tap
water. Any of these impurities in tap water can cause problems within the cooling
water system.
Irrigation
Sterile irrigation fluid flows from an I.V. set (bottle or bag and I.V. administration
tubing) to a variable speed peristaltic pump:
• The pump moves fluid at 1 to 10 cc/min; default flow is 3 cc/min. Adjustment
buttons (blue up/down arrows on black buttons at the bottom of the irrigation
display column on the control panel) allow you to increase or decrease the
irrigation flow.
• The pump can also accelerate to a Fast Flush speed, pumping at 25 to 30 cc/
min. The Fast Flush pedal on the CUSA EXcel system footswitch activates
the Fast Flush feature.
The pump pushes the fluid through the manifold irrigation tubing to a flue, a
sleeve surrounding the vibrating tip. As the irrigation fluid passes through the
flue, it cools the tip.
When the fluid reaches the distal end of the tip, as much as 99% of it passes
through two pre-aspiration holes in the tip, eliminating fluid pooling on the sterile
field and continually clearing the suction system. The fluid that does not pass
Introduction
through the pre-aspiration holes irrigates the surgical site and suspends
fragmented tissue.
Figure 2-1.
The pre-aspiration holes and threads Pre-aspiration Hole (2)
on tips
Threads
Aspiration (Suction)
A vacuum pump in the console body provides up to 660 mm (26 in.) mercury
maximum vacuum at sea level. Adjustment buttons (green up/down arrows on
black buttons at the bottom of the aspiration display column on the control panel)
allow you to increase or decrease the suction from 10 to 100% in 10% increments.
The suction, which produces an air stream moving toward the vacuum pump,
pulls irrigation fluid, fragmented tissue, and other materials through the distal end
of the surgical tip. From the tip, the aspirated materials pass through the manifold
suction tubing into the suction canister. From the suction canister, the air stream
continues to flow through a contamination guard that filters any remaining
particulate matter or moisture, preventing them from entering the vacuum pump.
A suction pinch valve on the front of the console opens when the system is on and
closes to stop suction in the following cases:
• When priming the irrigation system
• When pressing the Fast Flush pedal
• In Run Status, when you release the Vibration pedal. In this case, the pinch
valve closes for about one second, then re-opens.
• In Lap Mode, when you release the Vibration pedal. This suction stoppage
prevents depletion of the pneumoperitoneum.
Caution
To avoid injury to surgical personnel, keep fingers away from the suction pinch valve.
When the System Power Switch is off, the suction pump remains off and the
suction pinch valve remains closed. A button on the front of the suction pinch
valve allows you to open the valve manually.
Handpieces
The CUSA EXcel system includes three handpiece configurations:
• 36 kHz, straight (smaller handpiece, black body, blue connector)
• 23 kHz, straight (gray body, green connector)
• 23 kHz, angled (gray body, green connector)
Figure 2-2.
The three handpieces in the
CUSA EXcel system 23 kHz
Straight
36 kHz
Straight 23 kHz
Angled
Introduction
Wide Variety of Tips
You can use a wide variety of tips with the CUSA EXcel handpieces. Tips vary in
inside diameter, length, and shape (straight or curved). For complete information
on the tips that are available for each handpiece, refer to Appendix A, Tip
Specifications, in the CUSA EXcel Ulstrasonic Surgical Aspirator System User’s
Guide.
In this section:
Unpacking Procedure
1. Cut the vertical bands on
the shipping crate. Remove
the bands.
Note: Save the box edge
protectors for use when
shipping the system.
4. Remove the three plastic clips that hold the crate closed. (If the clip is
especially tight, you may need to use pliers for this step.) Refer to the
following figure.
a. Inside the clip, grasp the two horizontal bars near the locking retainer (on
the right side of the clip).
b. Squeeze the bars toward each other to release them from the locking
retainer.
c. Pull the bars toward you. They should swing outward.
d. Pull the tab at the bottom of the clip to remove the clip from the carton.
Caution
To prevent the ramp from falling and causing injury, be sure to hold the ramp in the up
position while cutting the corrugated tab that secures it to the carton.
9. Remove the four interlocking foam pieces from the foam cushion around the
console (refer to the following figure).
Remove the right and left foam cushions from the console.
11. The rear casters have direction locks that keep the wheels rolling in one
direction; the front casters have brake locks that, when locked, prevent the
wheels from rolling (refer to the following figure).
a. Unlock the front casters by lifting the lock lever upward.
b. Check the rear casters to be sure that, if locked, they will allow the console
to roll toward the ramp.
Put the box edge protectors and all foam packing materials into the clear plastic
bag for storage. Save all shipping components. You will need them if you need to
return the console to Integra. In fact, it is very important that you use the proper
brown line/hot
Important
Ensure that all electrical The power connector meets all requirements for safe grounding. Do not defeat its
installations comply with local purpose by using extension cords or three-prong-to-two-prong adapters.
codes and regulatory Periodically check the power cord for damaged insulation or connectors. Always
requirements. grasp cords by the connector; do not pull on the cord to remove the connector
from the wall receptacle.
If required by local regulations, connect an equipotential grounding cable to the
Notice
To avoid product damage, be sure to insert fuses that are appropriate to the power supply:
• 95 to 120 V, T10A, Time Delay (default)
• 220 to 240 V, T5A, Time Delay
Console Components
4
In this section:
Control panel
I.V. pole
Arm
Housing for
irrigation pump head
and suction pinch
valve
Arm housing
Console body
Cooling water
reservoir
Casters
I.V. Pole
Attached to the right side of the console, it supports the sterile irrigation fluid
container. You can raise or lower the pole; you can also rotate the pole 90° in the
lower position.
Control Panel
Mounted on the arm, the control panel allows the user to control all system
functions. The next page presents control panel details.
Console Body
The main body of the console unit contains the electronics, pumps, and other
working components. A later page presents console body details.
Casters
Console Components
Unlocked, both front and rear casters roll easily and rotate freely.
• Front casters have brake locks that stop the wheels from rolling.
• Rear casters have direction locks; when locked, casters remain fixed in one
direction.
Control Panel
A slot in the rear of the control panel allows you to store the quick reference
guide.
Figure 4-2.Control panel features
Displays
(Green LED
columns and values)
Alerts
All alerts are red. When lit, the alerts indicate the following:
Alert Alert: An alert condition exists.
Footswitch: Connector not plugged into its receptacle on the console rear panel.
Displays
Green light emitting diodes (LEDs) show user adjusted setpoints for Aspiration,
Irrigation, and Amplitude:
• Not Activated: One LED illuminates to show the setpoint value
• Activated: All LEDs up to and including the setpoint value light up.
For TissueSelect, “Std” (standard) is the first setpoint value; “++++” is the highest
setpoint value.
Console Components
Figure 4-3.
Control panel features (continued)
Status indicators:
Run (Green)
Standby (Amber)
Wait/Cooling Water (Amber)
Status Indicators
To change from Standby to Run, or from Run to Standby, press the Status button.
Run: A green LED illuminates to show when the system is in Run status.
Handpiece
connector
receptacle
System power
switch
Contamination guard
When closed, the valve pinches off suction flow to the handpiece:
• When priming the irrigation system
• When pressing the Fast Flush pedal
• In Run Status, when you release the Vibration pedal. In this case, the pinch
valve closes for about one second, then re-opens.
• In Lap Mode, when you release the Vibration pedal. This suction stoppage
prevents depletion of the pneumoperitoneum.
The suction pinch valve default position (system off) is closed. If the System has
been running, when you turn the Power Switch off, the suction pinch valve
remains open until the drain cycle has finished, then closes. A button on the front
of the suction pinch valve allows you to open the valve manually.
Contamination Guard
Important
The guard is hydrophilic and Protects the vacuum pump from particulate matter and moisture in the suction
becomes blocked when wet. stream. It is necessary to replace the contamination guard every six months or
when it becomes blocked.
I.V. pole
Control panel
Control Panel
Refer to pages 4-4 through 4-7.
I.V. Pole
Refer to pages 4-2 and 4-3.
The reservoir also includes fittings that snap into receptacles inside the Arm
Housing on the console side panel. The fittings and receptacles automatically
connect the reservoir to the cooling water system.
Speaker
Volume control
Footswitch
connector receptacle
AC main switch
Fuses (2)
Footswitch
Integra LifeSciences (Ireland) Limited
IDA Business and Technology Park
Stragh, Tullamore, County Offaly, Ireland
Speaker
The speaker sounds an audible tone when an alert condition exists and when
vibration is active.
Volume Control
This potentiometer allows you to adjust the active vibration audible tone. You
cannot adjust the alert tone.
AC Main Switch
This switch controls the flow of AC power to the CUSA EXcel system. It does not
activate the system; instead, it allows power to flow from the wall receptacle to
the System Power Switch.
Once the AC Main Switch is On ( | ), you can leave it On even when you unplug
the system from the wall receptacle.
Fuses
These protect the system from electrical overloads. Refer to Section 11,
Replacement Procedures for instructions on replacing the fuses.
Footswitch
The footswitch has two pedals in a base, and allows you to activate two functions:
• Ultrasonics/vibration: Right pedal (orange), when pressed, activates vibration at
the tip. When you release the pedal, vibration stops.
• Fast Flush: Left pedal (blue), when pressed, increases the irrigation rate to
25 to 30 cc/min. It also closes the Suction Pinch Valve, stopping suction. When
you release the pedal, irrigation returns to the setpoint value and suction
resumes.
Console Components
Figure 4-7.
Console—rear view (continued)
Storage compartment
Cord wraps
AC Power Cord
Connects power to the system from the wall receptacle.
Label
The label shows the console serial number, model number, and agency approvals.
Cord Wraps
The unit has two cord wraps. These are brackets that allow you to hang two coils
of cord on the back of the unit, keeping the cords safely out of the way.
Storage Compartment
This area, which includes one interior shelf, allows you to store a footswitch and a
manual.
Console Components
Cooling water:
Alert (red, left side of the control panel)—failure
Wait (amber, right side of the control panel)—system is circulating cooling water
through the handpiece or draining the handpiece
On On/selected
Other Features
The CUSA EXcel console offers other convenient features:
• Easy-to-fill cooling water reservoir
• Adjustable arm height
• Rotating control panel
• Adjustable audible tone
• Adjustable I.V. pole.
The next portion of this section tells you how to use these features.
2. Fill the reservoir with 1000 cc distilled water (to the line).
3. Continue to move the arm up or down until it reaches the next position at
which the lock engages. You will feel and hear the arm click into place in the
locked position.
Integra
IDA
Business
Stragh,
and
Technology
LifeSciences
Tullamore,
County
Offaly,
Limited
(Ireland) Park
Ireland
4. If you want to move the arm to another position, press the release tab again
and continue to push gently on the arm.
Ultrasonics Tone
Volume Control
This tone (constant) sounds when you press the Ultrasonics pedal on the
footswitch. You can adjust its volume.
To adjust tone volume, rotate the stem on the volume control potentiometer
located just above and to the right of the footswitch connector receptacle on the
console rear panel:
• Volume up—clockwise
• Volume down—counterclockwise
Note: At its lowest volume, the ultrasonics tone is barely audible. You cannot turn
off the ultrasonics tone.
Limited
(Ireland) Park
Ireland
Offaly,
Technology
LifeSciences
and
County
Integra
Business
IDA Tullamore,
Stragh,
Alert Tone
This tone (on/off) sounds when an alert activates. You cannot adjust the volume
of the alert tone.
Important
Do not try to raise the pole from 1. Grasp the pole and rotate it to position B.
Position A. Do not try to rotate the
pole when it is in the upper 2. With one hand, hold the pole; with the other hand, press the button to release
position. the locking pin.
3. Raise the pole. As the pole clears its lower locking position, release the
button.
4. Continue to move the pole upward until it locks into position.
4. After the pole has locked into its lower position, you can rotate it to position
A.
Technical Specifications
5
In this section:
• Console dimensions
• Console subsystems
• Electrical requirements
• Environment
• Standards and IEC classifications
• Handpieces
• Tip specifications.
Console Dimensions
Footswitch
Console Subsystems
Ultrasonic
Fluidic System
Technical Specifications
Cooling System Cooling water flow is 35–50 cc/min
Electrical Requirements
Power Rating The CUSA EXcel system operates on one of the following
voltage ranges:
95 – 120 Volt (default)
220 – 240 Volt
Frequencies 60 Hz ± 2 Hz
50 Hz ± 2 Hz
Line fusing resides in fuse receptacles on the rear panel. The fuse values for 95–
120 volt operation are T10A; for 220–240 Volt operation, T5A. Refer to Section
11, Replacement Procedures, for instructions on replacing the fuses.
Power Cords
If a facility intends to use the CUSA EXcel system in an operating room with
another type of receptacle, the facility is responsible for replacing the connector
on the power cord. The replacement connector must be properly grounded.
Warning
Explosion Hazard Do not use the CUSA EXcel system in the presence of flammable
anesthetics or any potentially explosive or flammable atmosphere.
Duty Cycle
Under maximum loading conditions, the CUSA EXcel console is suitable for
ultrasonics activation times of 10 minutes on, 5 minutes off.
Environment
Operating temperature 10° C (50° F) to 40° C (104° F)
range
The system requires a minimum of one hour exposure at its operating temperature
range before you use it.
Technical Specifications
ATTENTION
Consult accompanying documents.
DANGER
Explosion risk if used with flammable anesthetics.
EQUIPOTENTIAL GROUND
Connect equipotential ground cable here.
POWER ON
Applies power at the AC Main Switch and the System Power Switch.
POWER OFF
Removes power at the AC Main Switch.
CAUTION
To reduce the risk of electric shock, do not remove the cover. Refer servicing to
qualified service personnel.
Classified with respect to electrical shock, fire, mechanical, and other specified
hazards only in accordance with UL60601-1 and CAN/CSA C22.2 No. 601.1.
Electromagnetic Interference
The CUSA EXcel console minimizes electromagnetic interference to other
equipment used in the operating room. The system complies with the
requirements of IEC 801.
Note that other devices in the operating room may generate electromagnetic
interference. Use caution in locating equipment within the room to reduce the
electromagnetic interference.
Caution
To avoid injury to surgical personnel, keep fingers away from the suction pinch valve
while powering the unit on or off, activating vibration, or using fast flush.
Fuse Replacement
Indicates the location of the fuse holder on the rear panel.
Footswitch Symbols
The following symbols appear on the CUSA EXcel footswitch:
Activate vibration.
Voluntary Standards
The CUSA EXcel system meets the following standards:
Technical Specifications
• UL 60601-1
EMC Compatibility
Notice
The CUSA EXcel should not be used adjacent to or stacked with equipment other than
specified in the CUSA EXcel User Guide and Service Manual. If adjacent or stacked use
is necessary, the CUSA EXcel should be observed to verify normal operation in the
configuration in which it will be used.
The electrical surgical generator used with the CUSA EXcel intentionally applies RF
energy for diagnosis or treatment during activation. Observe other electronic medical
equipment in the vicinity during the CUSA EXcel activation for any possible adverse
electromagnetic effects. Ensure adequate separation of electronic medical equipment
based on observed reactions.
The use of accessories, other than specified in the CUSA EXcel User Guide and Service
Manual, may result in increased emissions or decreased immunity of the CUSA EXcel.
The CUSA EXcel is intended for use in the electromagnetic environment specified below. The customer or the user of the CUSA
EXcel should assure that it is used in such an environment.
Technical Specifications
The CUSA EXcel is intended for use in the electromagnetic environment specified below. The customer or the user of the CUSA
EXcel should assure that it is used in such an environment.
Electrostatic discharge (ESD) +/-6 kV contact +/-6 kV contact Floors should be wood,
IEC 61000-4-2 concrete or ceramic tile. If
+/-8 kV air +/-8 kV air
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient/burst +/-2 kV for power supply lines +/-2 kV for power supply Mains power quality
IEC 61000-4-4 lines should be that of a typical
+/-1 kV for input/output lines
commercial or hospital
+/-1 kV for input/output lines
environment.
Surge +/-1 kV differential mode +/-1 kV differential mode Mains power quality
IEC 61000-4-5 should be that of a typical
+/-2 kV common mode +/-2 kV common mode
commercial or hospital
environment.
Voltage dips, short <5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) Mains power quality
interruptions and voltage for 0,5 cycle for 0,5 cycle should be that of a typical
variations on power supply commercial or hospital
40% Ut (>60% dip in Ut) 40% Ut (>60% dip in Ut)
input lines environment. If the user of
for 5 cycles for 5 cycles
IEC 61000-4-11 the CUSA EXcel requires
70% Ut (>30% dip in Ut) 70% Ut (>30% dip in Ut) continued operation during
for 25 cycles for 25 cycles power mains interruptions,
it is recommended that the
<5% Ut (>95% dip in Ut) <5% Ut (>95% dip in Ut) CUSA EXcel be powered
for 5 sec for 5 sec from an uninterruptible
power supply or a battery.
NOTE Ut is the a.c. mains voltage prior to the application of the test level.
The CUSA EXcel is intended for use in the electromagnetic environment specified below. The customer or the user of the CUSA
EXcel should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 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 CUSA EXcel is used exceeds the applicable RF compliance level above, the CUSA
EXcel should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the CUSA EXcel.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communication equipment and the CUSA EXcel
The CUSA EXcel is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
Technical Specifications
Customer or the user of the CUSA EXcel can help prevent electromagnetic interferences by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the CUSA EXcel as recommended below,
according to the maximum output power of the communications equipment.
1 1.2 m 0.5 m 1m
100 12 m 5m 10 m
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 power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At a80MHz and 800MHz, 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.
Handpieces
Nominal Frequencies
Dimensions
23 kHz Straight
Length 22.2 cm (8.74 in.)
23 kHz Angled
Length 22.2 cm (8.74 in.)
36 kHz Straight
Length 13.9 cm (5.47 in.)
Tip Specifications
The table on page 5-9 shows specifications for tips that attach to the 23 kHz
handpiece.
The table on page 5-10 shows specifications for tips that attach to the 36 kHz
handpiece.
23 kHz
Table 5-1.
Technical Specifications
Tip Specifications—23 kHz
Standard Tip 7.98 [3.140] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 3.54
287 to 355 [0.0113 to 0.0140]
Angled Handpiece:
112 to 163 [0.0044 to 0.0064]
MicroTip 9.22 [3.630] 1.57 [0.062] 1.93 [0.076] Straight Handpiece: 3.99
279 to 355 [0.0110 to 0.0140]
Angled Handpiece:
127 to 183 [0.005 to 0.0072]
Straight Extended 18.38 [7.238] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 16.15
Standard Tip 287 to 355 [0.0113 to 0.0140]
Angled Handpiece:
112 to 163 [0.0044 to 0.0064]
Curved Extended 18.38 [7.238] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 16.15
Standard Tip 287 to 355 [0.0113 to 0.0140]
Not compatible with angled
handpiece
MacroTip 7.95 [3.130] 2.64 [0.104] 3.18 [0.125] Straight Handpiece: 3.84
254 to 307 [0.0100 to 0.0121]
Angled Handpiece:
102 to 142 [0.0040 to 0.0056]
Laparoscopic Tip 30.14 [11.865] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 32.13
178 to 229 [0.007 to 0.009]
Not compatible with angled
handpiece
36 kHz
Table 5-2.
Tip Specifications—36 kHz
PrecisionTip 5.64 [2.221] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 1.37
Straight Extended 12.51 [4.924] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 7.86
PrecisionTip
Curved Extended 12.51 [4.924] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 7.86
PrecisionTip
MicroTip 5.28 [2.080] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 1.30
Straight Extended 12.15 [4.783] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 7.50
MicroTip
Curved Extended 12.15 [4.783] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 7.50
MicroTip
Standard Tip 4.57 [1.800] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 1.31
Straight Extended 11.44 [4.504] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 7.48
Standard Tip
Curved Extended 11.44 [4.504] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 7.48
Standard Tip
Principles of Operation
6
In this section:
Irrigation
solution
Irrigation
connection
Transducer
Handpiece
cable
Cooling
water out Cooling
water in Retainer
Handpiece Clip
housing
Electric coil
Vibrating tip
Flue
Electromechanical Operation
The CUSA EXcel console provides alternating current at 23 or 35.75 thousand
cycles per second (kHz) to the handpiece (the frequency depends on which
handpiece you connect to the console). In the handpiece, the current passes
through a coil, which induces a magnetic field. The magnetic field excites a
transducer of nickel alloy laminations, resulting in an oscillating motion in the
transducer laminated structure—vibration—along its long axis. The transducer
vibrates at 23 or 35.75 kHz.
Fragmentation
Principles of Operation
Fragmentation occurs when the vibrating tip interacts with tissue. As the tip
begins to move toward tissue, it accelerates, impacts the tissue, then penetrates the
tissue. The acceleration, impact, and penetration produce a combination of direct
mechanical forces and hydrodynamic pressures that burst cells.
Cooling
The high frequency vibration generates heat. To reduce the heat, the CUSA EXcel
system includes a closed, recirculating cooling water system. This system pulls
water from a cooling water reservoir, through a tube in the handpiece cable,
through the handpiece, and through a return tube in the handpiece cable to the
cooling water reservoir. Cooling water flows at 35 to 50 cc/min.
As it passes through the handpiece, the water removes heat. Normal handpiece
temperature, in sustained heavy use, remains at about 40° C (104° F).
Use distilled water for the cooling water system because it does not contain
natural minerals, chemical additives, or organic materials that are present in tap
water. Any of these impurities in tap water can cause problems within the cooling
water system.
Principles of Operation
tissue, it feels like it is “bouncing off” the tissue. Also, the smooth, rhythmic
sensation becomes rougher. To avoid fragmenting high strength tissue, the
surgeon must apply less pressure to the tip or move the tip away from the tissue.
To continue fragmenting high strength tissue, the surgeon must manually apply
more pressure.
However, the surgeon may not always recognize the difference in tactile feedback
quickly enough, or react quickly enough, to avoid damaging vital structures,
particularly those with a tissue strength similar to the tissue being fragmented.
The CUSA EXcel system can help the surgeon when dissecting near vital
structures.
The CUSA EXcel ultrasonic generator delivers electrical power (which is directly
related to the acoustic power present at the tip, which results in fragmentation) to
the handpiece. You can think of the power delivered to the handpiece in three
terms:
• Initial power—the quantity of power necessary to drive the tip vibration in air;
that is, no contact with tissue.
• Reserve power—the power necessary to maintain tip vibration under load (in
contact with tissue). When the tip encounters load, a feedback loop in the
system senses the additional load and provides additional reserve power to
maintain tip vibration.
• Maximum power—the greatest power output the console can provide.
Maximum power is the sum of initial and reserve power.
+ 40 ms 10 ms
++ 30 ms 10 ms
+++ 20 ms 10 ms
++++ 10 ms 10 ms
Principles of Operation
At a 100% Amplitude setting, as TissueSelect settings increase, on-time and
reserve power decrease.
The TissueSelect feature offers five settings from “std” (standard—least selective)
to ++++ (most selective). The std setting selects continuous power, resulting in
ample reserve power. The ++++ setting selects the least power.
Standard Operation
Power is continuous. The ultrasonic generator provides ample reserve power;
more than is necessary to drive stroke amplitude under heavy load:
• The tip fragments “softer” tissue easily.
• The tip fragments “stronger” tissue, but with more difficulty (slower, requires
more surgeon pressure).
TissueSelect Operation
Power is interrupted. The ultrasonic generator provides less reserve power to the
handpiece:
• The tip still fragments “softer” tissue easily.
• But, when it encounters “stronger” tissue, the power the tip receives is no
longer enough to fragment the tissue. The tip stalls.
At increased selectivity settings (+ to ++++), suction and the tip cross-sectional
area remain the same, and stroke amplitude and tip acceleration decrease slightly:
Table 6-2.
Fragmentation performance vs.
TissueSelect settings
Setting Fragmentation Rate
Benefits of TissueSelect
The TissueSelect feature presents several benefits:
• Maintains fragmentation ability.
• Reduces (automatically) fragmentation rate.
• Provides maximum tissue selectivity.
• Gives surgeon superior tactile feedback.
• Gives surgeon greater control and precision when dissecting near delicate
structures.
Principles of Operation
Figure 6-3.
Reserve power vs. amplitude setting
Circuit Theory
7
In this section:
• Display board
• Machine control board
• Ultrasonics board–ultrasonic generator
• Ultrasonics board–other circuits
• System 24 V Power Supply board.
Display Board
General Description
The display board contains the user information displays and user input buttons
for the unit. User input buttons control the following settings and functions:
• Settings:
Amplitude
Aspiration
Irrigation
TissueSelect.
• Functions:
Status (run or standby)
Lap
Test
Prime.
The display board also includes four fault indicators (alerts):
• Vibration
• Footswitch
• Handpiece
• Cooling water.
The PCB is a single, four-layer circuit board. It includes both through-hole and
surface-mount parts due to space constraints on the board and the quantity of
parts. The buttons and electronics provide bi-directional data communication with
the machine control board via a 50-pin ribbon cable.
Fundamentals of Operation
The display board, the fundamental user interface for the system, both receives
and displays information to the user. Figure 7-1 shows the display organization.
Figure 7-1.
The display organization on the
control panel
Due to the quantity of LEDs, space restriction, and heating considerations, FET
switches connected to a multiplexing display driver (Maxim 7218) drive the
displays. A resistor in series with the LED light bar limits current through the
LEDs. A P-channel FET sources the voltage to the resistor and LED light bar
series combination. An N-channel FET sinks the current to ground from the LED
light bars. The outputs of the 7218 display driver control the gates of the FETs.
To reduce the number of display drivers and the quantity of logic code, a coded
map identifies each individual LED light bar location so that a single display
driver can control all of the amplitude, irrigation, TissueSelect, and aspiration
displays. A second display driver controls the number legends, the alerts, the
status indicators, and the button indicators.
Circuit Theory
Detailed Circuit Description
Each “circuit” works the same way. It simply repeats several times to allow
individual control over each light bar package. The following description details
the circuit for the aspiration column at a setting of 10%.
The 7218 display driver (U3) receives inputs from the machine control board via
the 50 pin ribbon cable connector, J1. The segment output of the display driver
connects to a 1k pull-up resistor (RA2) and the gate of an N-channel FET (U66).
The source of the FET ties to +5Vin and the drain connects to a resistor network
(RA32). Several of the resistors are tied together to achieve an average current of
12 mA through each LED of the light bar for a total of 96 mA per light bar. The
resistors, in parallel, connect in series with the light bar (U221). All diodes in the
light bar connect in parallel. The cathode of the diode connects to the drain of the
N-channel FET (U65). The source of U65 connects to ground. The gate connects
to a digit output of U3 and a pull-down resistor (RA6).
For any light bar to be illuminated, it must receive both the correct segment and
digit output from the display driver. Each LED light bar (except for the numeric
legends) has a unique map location; thus, each LED light bar is independently
controlled. The numeric legends are controlled together, not independently.
Introduction
The Machine Control board resides in the control panel assembly along with the
Display board. The Machine Control interfaces with the ultrasonic section of the
display and keypad. It also interfaces to the solenoid valves, pumps, and the
ultrasonic drive circuitry. This description presents the Machine Control
schematic. Refer to the Schematics Supplement.
Irrigation Pump
A resistor divider and operational amplifier network establishes control for the
irrigation pump. The programmable logic device (PLD) sets the levels. The
signals are optically isolated and sent as inputs to a quad analog switch. The
analog switch selects gain resistors for an op amp, which is amplifying a dc level.
The op amps output drives a pump speed controller (off board) which has a
greater than 10k ohm input resistance.
The 5-bit output signal range for the irrigation pump is approximately
0 to 5V DC. The following table shows the irrigation steps:
Table 7-1.
Irrigation pump voltage steps irrigation step 5v_x = 5.6v
1 0.28 2 0.32
2 0.45 3 0.47
3 0.61 4 0.63
4 0.78 5 0.79
5 0.93 6 0.95
6 1.1 7 1.11
7 1.3 8 1.27
8 1.45 9 1.43
9 1.6 10 1.59
10 1.75 11 1.75
ff max 5 16 4.98
Suction Pump
Suction pump control results from the same kind of operation as irrigation pump
control. The 4 bit output signal range for the suction pump is approximately 0 to
6V DC. The following table shows the suction steps:
Table 7-2.
Suction pump voltage steps suction step +5v_sp = 6.15v
1 0.40
2 0.80
3 1.20
4 1.61
5 2.00
6 2.41
7 2.81
8 3.23
9 3.63
10 4.03
12 4.84
Circuit Theory
13 5.23
14 5.64
max 6 15 6.03
Cooling Pump
Cooling pump control results from the same kind of operation as irrigation and
suction pump control. The 3-bit D/A output signal range for the cooling pump is
approximately 0 to 5.1V DC. The following table shows the cooling steps:
Table 7-3.
Cooling pump voltage steps cool step +5v_x= 5.6v
1 0.73
2 1.46
4 2.94
5 3.67
6 4.40
Suction Valve
Optically isolated digital circuits control the suction valve. When current moves
through an internal LED, the output open collector transistor is saturated. The
pull-up resistors and the controlling hardware reside on the destination board.
Amplitude Control
The handpiece amplitude control circuit, a 4-bit D/A output signal range for the
handpiece control, operates from approximately 0 to 10V DC. The op amp
maximum supply voltage is 15V, so two diode drops prevent the op amp from
seeing the full 15V from the supply. The following table shows the handpiece
amplitude control steps:
Table 7-4.
Handpiece amplitude control amp step desired voltage D/A code theoret v
voltages
1 1.00
2 2.01
2.208 3 3.01
4 4.04
5 5.04
6 6.05
7 7.05
8 8.11
9 9.11
max 10 10.13
11 11.13
12 12.15
13 13.15
14 14.16
15 15.16
Valve Controls
Optical isolators condition signals to and from the ultrasonics board. The signals
from the footswitch activate fast flush and the ultrasonics, and indicate whether
the footswitch is present. There are several isolated solenoid valve drivers for
controlling tissue release, suction, handpiece drain, and anti-siphon. The
handpiece feedback signals from the ultrasonics board go through opto-isolators
to the PLD. Alert signals such as cooling out of range, vibration, amplitude, and
Circuit Theory
handpiece not present also pass through opto-isolators before going into the PLD.
Voltage Regulators
There are voltage regulators for the isolated supplies. LM317 adjustable
regulators provide op amps with supply voltages with enough overhead margin to
output voltages in the required range. A switching regulator boosts and regulates
the 5V supply for the machine control and display driver boards. This is necessary
because the 5Vin signal is expected to dip momentarily due to the voltage drop
when the displays are lit up. A diode placed around the regulator eliminates start
up delay in the 5V supply for the PLD. This sheet shows bypass capacitors as well
as the independent power shutdown driver circuits. The open collector output
signals drive an opto-isolator LED inside the power modules in order to shut off
the supplies.
Interface Connectors
J2 and J3 are the ultrasonics interface connectors. J1 is the 5V input power supply
connector. J5 is the power shutdown control connector. J4 is the display board
interface connector.
Fundamentals of Operation
The CUSA EXcel ultrasonic generator is based on the principle of the Wien
Bridge Oscillator. The system has a non-inverting feedback loop to establish the
fundamental frequency of oscillation and an additional negative feedback loop,
which controls the amplitude of oscillation. The fundamental oscillation
component is a function of the resonant frequency of the magnetostrictive
handpiece.
Oscillation criteria for a Wien Bridge are that the gain around the loop must add
up to unity and the phase must add up to 360º or 0º. Only if the gain is initially
greater than unity and some perturbation (noise) in the initial conditions of the
system exists can startup occur.
The handpiece design uses the magnetostrictive and inverse magnetostrictive
effects. A magnetic field produces a small change in the physical dimensions of
ferromagnetic materials—on the order of several parts per million in steel—and,
conversely, a physical deformation or strain (or stress which causes strain)
produces a change of the magnetization in the material.
Much like a tuning fork excited by a “ping” or deformation, the handpiece
transducer—excited by these small deformations caused by the magnetostrictive
effect—resonates at an ultrasonic frequency. Linear operation within this
framework relies on biasing the magnetic field at a roughly linear point along the
main B-H curve. The feedback signal, sensing the change in the magnetic field
produced by the inverse magnetostrictive effect, is proportional to the
deformation.
Circuit Theory
phase and gain over this region of interest is desirable; otherwise, poor power
factors and/or unstable operation could result. The AGC loop controls the
multiplier and, therefore, adjusts the frequency loop gain to control the amplitude
under varying load and handpiece operating conditions. Linear operation of these
two loops in conjunction is imperative to avoid handpiece operation at an
undesired point.
The output driver stage is a Class B push-pull current drive coupled to the
handpiece via a transformer and DC bias circuitry. Most magnetostrictive drives
use a current drive because the magnetic field intensity is linearly proportional to
the drive current—and, therefore, stroke—when the handpiece is properly biased.
handpiece is connected, compensates for some of this loss for the 35.75 kHz
circuit. The -3 dB point of the RF filter is at about 100 kHz to maximize RF losses
at 500 kHz and above, and to minimize passband phase.
The active filter is an analog state-variable structure “universal active filter” IC.
R95 and R96 determine the bandpass filter gain. R63, R75 and RV6 determine the
center frequency for the 23 kHz circuit (or R62, R65, and RV7 for the 35.75 kHz
circuit) as selected by the analog switches U10A, B, D, and U4C.
The BPF center frequency ensures that midband phase and gain are as flat as
possible, but losses at the undesired longitudinal modes are maximized. For the
23 kHz circuit, the first undesired mode occurs at about 26 kHz; for the 35.75 kHz
circuit, it occurs at approximately 43.8 kHz. Handpiece/tip length primarily
determines this mode, although handpiece/tip diameter also affects it. Loss at
these frequencies must come from two sources:
1. (Most obvious) BPF loss at these frequencies. However, the AGC loop gain
may, in most instances, be sufficient to negate this loss.
2. Phase. If the phase is sufficient that the only operating point possible at this
mode requires a very high gain, then this will not be a preferred mode.
nominal error output. Under maximum load, the gain should be sufficiently large
to allow stroke, even if the stroke is at reduced levels. If the gain is too large,
however, a large enough feedback will force the error amplifier output to 0,
whereby control is lost.
RV11 is for calibration purposes only.
Phase Compensator
The two-pole, active filter, U9, provides loop phase compensation. This is a
Bessel filter characteristic implemented with a “low sensitivity” configuration. It
is “low sensitivity” in that it has low operational amplifier (op-amp) slew rate and
drive requirements, while component temperature and tolerance sensitivities also
remain low. The phase for the 23 kHz circuit depends on the RC value of RV5,
R52, and C41 selected by the analog switch U5A; the phase for the 35.75 kHz
circuit depends on RV4, R300, and C41 selected by U5D. The nominal -3 dB
point of the filter is 37.30 kHz.
The alignment of these filter poles with the BPF determines the amount of phase
at the undesired longitudinal modes. Too little phase from the BPF makes it
difficult to adjust these modes out; too much phase allows the center frequency to
remain mis-adjusted and, therefore, may sacrifice mid-band gain flatness.
Driver Stage
The driver stage consists of the following components:
• A pre-amp, U1B
• A push-pull rectifier or phase splitter, U1A
• A positive half-cycle driver, U2B
• A negative half cycle driver U2A.
Circuit Theory
For the 23 kHz circuit, output stage gain depends on the combination of two
gains:
• The pre-amp gain (R10 and R11)
• The phase-splitter gain (R19, R20, R24, and RV3).
For the 35.75 kHz circuit, output stage gain depends on RV2, selected by switches
U5C and U5B.
The RUN_HPO signal from the machine control board via switch U4D enables
the whole frequency loop.
U2A and U2B connect as non-inverting and inverting current sources via the
feedback of the 0.25 Ohm resistors. Maximum current in the output transistors (20
amps peak) depends on the gain set by R13 and R15 for the positive half-cycle,
and R41, R36, R18, and R17 for the negative half-cycle. Amplifier compensation
for the positive half-cycles depends on R14 and C21; for the negative half cycles,
R40, C35 and C15.
CR7 and CR2 protect output transistors Q15 and Q16 from the output transformer
flyback; R38 protects the output transistors from open-circuit loading (like a
short-circuit for voltage based designs). The output transformer is center tapped
with a ratio of 1:4.6 for each half coil.
C10 provides AC coupling to the DC biased handpiece and its value is selected
low enough to avoid resonant circuit interactions with the handpieces.
Feedback Signal
U13B, U11, U14, and U18 filter and convert the feedback signal to digital. The
signal level depends on the gain of the amplifier U13B, R77, and R78.
Bias Circuitry
The bias circuit consists of the following items:
• A pass transistor switch, Q1
• Filter components L5 and C9
• CR1.
The filter prevents ultrasonic signal leakage from returning to the power supply,
while CR1 acts as a free wheeling diode when Q1 is turned off.
Valve Drivers
Pulse and hold circuits driven by the Machine Control board control the suction,
syphon, and tissue release valves. U6, U3, and U19 provide drive current sinks.
Resistor combinations determine the pulse and hold currents.
Circuit Theory
The CUSA EXcel uses an OEM medical grade 600 watt power supply with an
input voltage range of 88 to 264 VAC. The supply has two individually regulated
24 VDC outputs. This power supply is an enhanced leakage current version with
earth leakage of less than 150 A. This supply is a UL recognized component for
Canada and the U.S. and is CE labeled.
Checkout Procedures
8
In this section:
• Inspections
Footswitch
Power cord
• Power on verification
• Handpiece test (optional).
Inspections
When you have unpacked the console, and at regular intervals afterward, inspect
the footswitch and the power cord.
Footswitch
1. Disconnect the footswitch from the console (rear panel).
5. Clean the footswitch and cable with a damp cloth and mild detergent.
Power Cord
1. Unplug the system power cord from the wall receptacle.
2. Inspect for damage or corrosion. Ensure that the connector screws are tight.
4. Clean the power cord with a damp cloth and mild detergent.
Power On Verification
1. Connect the footswitch.
3. Turn on (|) the AC Main Switch, located on the rear panel. The front panel
indicators momentarily flash.
4. Turn on (|) the System Power Switch, located on the front panel.
5. The front panel indicators momentarily flash. The Handpiece and Alert
indicators (red, left side of control panel) illuminate.
Notice
To avoid product damage, NEVER hold the handpiece in your hand while using the
torque wrench to tighten or loosen the tip.
Limited
(Ireland) Park
Ireland
Offaly,
Technology
LifeSciences
and
County
Integra
Business
IDA Tullamore,
Stragh,
Checkout Procedures
System Power
Switch
7. Wait for the Cooling Water and flashing Wait indicators (amber) to turn off
(this indicates that the handpiece cooling water circuit is working properly). It
usually takes about one minute.
Caution
Do not allow the handpiece tip to contact anyone or anything during tip activation.
Contact may result in patient injury, user injury, or handpiece tip damage.
11. Wait for the handpiece cooling water to drain (the amber Wait and Cooling
Water indicators go off), then disconnect the handpiece. Checkout Procedures
In this section:
Every 3 months, or CUSA console 1. Fill the cooling water reservoir with
every 12 to 15 a solution consisting of 100 cc of
procedures, which- 70% alcohol and 900 cc of water.
ever comes first
2. Connect the handpiece, then turn on
the system.
3. Allow the system to run a few
cooling cycles to clean the interior
tubing.
4. Turn off the system.
5. Discard the alcohol solution, then
fill the reservoir with distilled
water.
6. Turn on the system, and allow it to
cycle the water to clean the alcohol
solution out of the tubing.
7. Turn off the system.
8. Discard water from the reservoir.
Maintaining the
Once a year CUSA console Contact an Integra service
representative to replace the cooling
water pump tubing.
Warning
Electric Shock Hazard Always unplug the CUSA system before cleaning.
Notice
Do not rub, press, or touch any panels with solvents; caustic, corrosive, or abrasive
cleaning or disinfectant compounds; or other materials that could scratch the panels. Do
not use a betadine-based solution; it will cause discoloration.
2. Using standard procedures for your facility, thoroughly wipe all surfaces and
cords with a cleaning solution and disinfectant.
3. Make sure that the surface is completely dry before using the system again.
Notice
Do not clean the sterilizer case with abrasives. Product damage will result.
Notice
Product damage will result if you do not follow these notices when cleaning the
handpiece:
• Do not immerse the handpiece cable electrical connector in liquid.
• Do not use ultrasonic or automated cleaners.
• Do not use chlorinated substances such as bleach solution.
• Do not clean the handpiece with abrasives such as Ajax, Comet, or steel wool.
Procedure:
1. Using a soft cloth, manually clean the handpiece, handpiece cable, and
standard nosecone with a mild cleansing solution (neutral detergent) or blood
dissolving detergent according to hospital policy.
2. Using a swab or pipe cleaner, manually clean the internal threads and suction
port of the connecting body.
3. Using a soft cloth, manually clean the internal threads and face of the
connecting body. Refer to Figure 9-1.
Figure 9-1.
Cleaning the handpiece with a soft
cloth
4. Rinse the handpiece cable, handpiece housing, connecting body, and nosecone
thoroughly with water.
5. Using a soft cloth, dry the handpiece cable, handpiece housing, connecting
body, and standard nosecone.
Items Needed
Detergent, two soft cloths, and rinse water.
Procedure:
1. Using a soft cloth and a water and detergent combination, manually clean the
tip torquing base and the torque wrench.
2. Rinse the tip torquing set thoroughly with water.
3. On the torque indicating wrench, adjust the scale under the indicator needle to
zero.
4. Set the peak indicating needle on the torque indicating wrench to zero.
5. Place the green end of the torque wrench from the tip torquing set on the 9/32
in. hex socket.
6. Rotate the tip torquing wrench clockwise until you feel and hear a click.
7. Rotate the tip torquing wrench clockwise until you feel and hear a second
click.
Maintaining the
11. All values must be in the following ranges:
Table 9-2.
Torque values for the torque wrench Handpiece frequency Range (inch-pounds)
23 kHz (green) 55 to 70
36 kHz (blue) 20 to 32
If the values are higher or lower, send the wrench to Integra for recalibration.
CUSA Console
Drain all liquids. Store the CUSA system in a low traffic area that is free of dirt,
blood, water, and other contaminants. Store the system at an ambient temperature
between -34° C (-29° F) and 65° C (149° F).
Handpiece
Drain all liquids. Store the handpiece in the sterilizer case according to your
facility’s policy.
Store the handpiece at an ambient temperature between -34° C (-29° F) and 65° C
(149° F).
Footswitch
If you have attached the footswitch to the console, you do not need to disconnect
it except for maintenance or service. When you are not using the CUSA system,
store the footswitch in the storage compartment in the rear of the console.
CEM Nosecone
The CEM nosecone is a sterile, single-use item. Store unopened packages; discard
used CEM nosecones.
10 Troubleshooting
In this section:
• Troubleshooting safety
• User troubleshooting
Responding to alerts
General troubleshooting
• Engineer troubleshooting
Guidelines
Flow Charts.
This section repeats the user troubleshooting tables presented in Section 13,
Troubleshooting the CUSA EXcel System, in the CUSA EXcel Ultrasonic
Surgical Aspirator System User’s Guide. It then presents engineer
troubleshooting, describing a visual inspection of the CUSA EXcel system (to
detect any obvious problems) and including flow charts for troubleshooting the
system as a whole and each of its subsystems.
Troubleshooting Safety
It is important that you read and understand the following warnings and notices:
Warning
Electric Shock Hazard Do not touch any exposed wiring or conductive surface while
the system is disassembled and energized. Never wear a grounding strap when working
on an energized system.
Electric Shock Hazard Take appropriate precautions (such as the use of isolated tools
and equipment; use of the “one hand rule,” etc.) when taking measurements or
troubleshooting the system.
Notice
Electrostatic Sensitive Devices This unit contains electrostatic sensitive components.
When repairing the system, work at a static control workstation. Wear a grounding strap
when handling electrostatic sensitive components. Handle circuit boards by their
nonconductive edges. Use an antistatic container for transport of electrostatic sensitive
components and circuit boards.
User Troubleshooting
The CUSA EXcel system runs nearly trouble free. However, on occasion, a
problem may arise. This section describes some conditions that may occur before
or during the normal course of surgery. They are easy to diagnose and to fix.
Warning
Do not activate vibration or the CEM handswitching nosecone while using the tip cleaner.
Tip damage, user injury, electrical shock, or any combination of these effects may occur.
Responding to Alerts
Footswitch Footswitch cable not properly connected Connect the footswitch to the console
to console (rear panel). Turn the connector until you
feel it lock into place.
If the alert persists after you connect the
footswitch to the console, call Integra for
assistance.
Handpiece Handpiece cable not properly connected Connect the handpiece to the console.
to console Twist the handpiece connector clockwise
until it locks into place, then verify that
the yellow dots align.
If the alert persists after you connect the
handpiece to the console, call Integra for
assistance.
Troubleshooting
Using a CUSA 200 system 23 kHz Connect a CUSA EXcel 23 kHz
handpiece (black connector) handpiece (green connector) or 36 kHz
handpiece (blue connector).
Cooling Water—continuously on Not enough distilled water in the cooling Add distilled water to the cooling water
water reservoir reservoir to the fill line.
Cooling water reservoir not properly Re-seat the cooling water reservoir in the
seated console.
A pinch or kink in the handpiece cable Remove the pinch or kink in the cable.
Handpiece cable not properly connected Connect the handpiece to the console.
to console Twist the handpiece connector clockwise
until it locks into place, then verify that
the yellow dots align.
Cooling Water—flashing on and off Possible air bubble in the handpiece The CUSA EXcel system corrects this
cooling system condition. However, if the Cooling Water
alert remains lit, refer to the condition
immediately before this one: Cooling
Water—continuously on.
A pinch or kink in the handpiece cable Remove the pinch or kink in the cable.
Vibration—In Test mode only Tip loose due to incorrect assembly Testing before sterilization:
1. Use the tip torquing base and wrench
to tighten the tip.
2. Test the tip.
3. Sterilize the handpiece.
Tip contacting another object Remove the contact with any other object.
Vibration—In Test mode only— Blocked tip 1. Verify that the manifold suction tube
continued connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
2. Use the tip cleaner to dislodge the
blockage in the tip. Continue to push
the tip cleaner into the tip until the
cleaner becomes visible in the tubing.
3. When you have cleared the blockage,
verify again that the manifold suction
tube connects properly to the
nosecone.
4. If the tip remains blocked, disconnect
the manifold suction tube connector
from the nosecone. Use the tip cleaner
to dislodge blockage from the tubing,
Troubleshooting
then reconnect the tubing to the
nosecone.
5. Immerse the handpiece tip in sterile
irrigation fluid briefly. This may clear
the suction tubing.
Vibration—In Test mode only— Damaged handpiece 1. Connect a new handpiece to the
continued CUSA EXcel console and test it.
2. If the new handpiece corrects the
problem,
• Verify that the previous handpiece is
correctly assembled, and
• If it was correctly assembled, send it
to Integra for repair.
If the problem persists after you replace
the handpiece, call Integra for assistance.
General Troubleshooting
No power at the console AC Main Switch (on the rear panel) off Turn on the AC Main Switch (on the rear
panel).
System Power Switch (front of console) Turn on the System Power Switch (on the
off front of the console).
Power cord not plugged in Plug the power cord into the wall
receptacle.
Wall receptacle has no power available Try another wall receptacle, or check the
operating room circuit breakers.
Power interruption to the console Power cord becomes unplugged 1. Turn off the System Power Switch
(on the front of the console).
2. Plug the power cord into the wall
receptacle.
3. When power is restored, turn on the
System Power Switch.
4. When the Wait light (flashing) turns
off, press the Prime button to make
sure the irrigation system is ready to
use.
5. Adjust the Aspiration, Irrigation,
Amplitude, and TissueSelect settings.
6. Push the Status button to change to
Run mode.
Power interruption in the operating Facility power loss 1. Turn off the System Power Switch
room (on the front of the console).
2. When power is restored, turn on the
System Power Switch.
3. When the Wait light (flashing) turns
off, press the Prime button to make
sure the irrigation system is ready to
use.
4. Adjust the Aspiration, Irrigation,
Amplitude, and TissueSelect settings.
5. Push the Status button to change to
Run mode.
No irrigation flow from the handpiece I.V. administration set roller clamp closed Open the roller clamp.
flue; the handpiece tip gets hot
Troubleshooting
Irrigation tubing not routed properly Route the irrigation tubing properly
through irrigation pump through the irrigation pump.
Not enough time set at Prime to allow Press the Prime button, allowing time for
fluid to pass through the irrigation tubing irrigation fluid to drip from the tip.
Irrigation tubing pinched or kinked Remove the pinch or kink from the
tubing.
Excessive misting at the handpiece tip Flue not lined up with tip pre-aspiration Adjust the flue position to line up with the
holes pre-aspiration holes in the tip.
Low or no suction due to suction tubing Verify that the manifold suction tube
improperly connected to handpiece connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
Excessive misting at the handpiece Blocked tip 1. Verify that the manifold suction tube
tip—continued connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
2. Use the tip cleaner to dislodge the
blockage in the tip. Continue to push
the tip cleaner into the tip until the
cleaner becomes visible in the tubing.
3. When you have cleared the blockage,
verify again that the manifold suction
tube connects properly to the
nosecone.
4. If the suction remains low, disconnect
the manifold suction tube connector
from the nosecone. Use the tip cleaner
to dislodge blockage from the tubing,
then reconnect the tubing to the
nosecone.
5. Immerse the handpiece tip in sterile
irrigation fluid briefly. This may clear
the blockage.
Blockage in the suction tubing at the 1. Immerse the handpiece tip in sterile
handpiece irrigation fluid briefly. This may clear
the suction tubing.
2. Press the Status button to change to
Standby mode. Use the sterile tip
cleaner to clean out the tip, then put
the tip in irrigating fluid to flush the
tubing.
3. As necessary, disconnect, clean, and
reconnect the suction tubing
connector at the handpiece.
A pinch or kink in the suction tubing Straighten the tubing to remove a kink, or
remove anything that might pinch the
tube.
A blockage in the suction tubing between 1. Examine the suction tubing along its
the handpiece and the suction canister entire length for a blockage.
2. Squeeze the blocked area to loosen it.
3. Immerse the handpiece tip in sterile
irrigation fluid briefly. This may clear
the blockage.
Excessive misting at the handpiece Suction connections at the suction 1. Remove any unused suction canister
tip—continued canister not seated properly “elbow” connectors.
2. Reseat all connections.
Open port(s) on the suction canister Close any open ports on the suction
canister.
Inside of the contamination guard wet and 1. Disconnect the contamination guard
blocked fitting from the suction canister
tubing. If you feel no suction at the
end of the contamination guard
fitting, the guard is blocked.
2. Replace the contamination guard.
Troubleshooting
Problem at the CUSA EXcel console Remove the contamination guard and put
suction port a finger in the suction system port. If you
feel no suction, call Integra for assistance.
Suction pinch valve working improperly Check the Lap mode indicator.
• If Lap mode is off, in Run mode the
pinch valve should be open.
• If Lap mode is on, in Run mode the
pinch valve should be open only when
you activate vibration.
If these conditions do not exist, call
Integra for assistance.
No green LEDs (other than setpoints) System in Standby mode Press the Status button to switch the
illuminate when you activate vibration system to Run mode.
Little or no vibration or fragmentation Excessive tip/tissue pressure (stalling tip) 1. Verify that console settings are at
(Amplitude LEDs may illuminate well desired levels.
below setpoint)
2. Remove the tip from contact with
tissue, then reactivate vibration.
Note: When first activating vibration,
make sure that there is no tip/tissue
pressure.
Little or no vibration or fragmentation Tip loose due to improper assembly 1. Press the Status button to place the
(Amplitude LEDs may illuminate well system in Standby mode.
below setpoint)—continued
2. Press the Test button to test the
handpiece and tip.
3. If the Vibration alert activates, do one
of the following:
If tip assembled in a nonsterile area:
a. Remove the handpiece from the
sterile field.
b. Use the tip torquing base and
wrench to tighten the tip.
c. Test the tip.
d. Sterilize the handpiece.
Troubleshooting
If sterile tip assembled to handpiece on
the sterile field:
a. Use the sterilizable torque base
and a disposable sterile wrench to
tighten the tip. (Refer to the
Supplement, Assembling or
Changing Tips on the Sterile
Field, in the CUSA EXcel
Ultrasonic Surgical Aspirator
System User’s Guide.)
b. Test the tip.
Little or no vibration or fragmentation Damaged or cracked tip 1. Press the Status button to place the
(Amplitude LEDs may illuminate well system in Standby mode.
below setpoint)—continued
2. Press the Test button to test the
handpiece and tip.
3. If the Vibration alert activates, do one
of the following:
If tip assembled in a nonsterile area:
a. Remove the handpiece from the
sterile field.
b. Use the tip torquing base and
wrench to replace the tip.
c. Test the tip.
d. Sterilize the handpiece.
If sterile tip assembled to handpiece on
the sterile field:
a. Use the sterilizable torque base
and a disposable sterile wrench to
replace the tip. (Refer to the
Supplement, Assembling or
Changing Tips on the Sterile
Field, in the CUSA EXcel
Ultrasonic Surgical Aspirator
System User’s Guide.)
b. Test the tip.
Suction tube won’t assemble correctly Nosecone not assembled to handpiece Align the dot on the nosecone with the dot
to handpiece nosecone correctly on the handpiece.
Low suction at the handpiece tip Low suction setting on the control panel Increase the setting.
System inadvertently in Lap mode Turn off the Lap mode by pressing the
Lap mode button.
Suction tubing improperly connected to Verify that the manifold suction tube
handpiece connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.
Troubleshooting
the tip cleaner into the tip until the
cleaner becomes visible in the tubing.
3. When you have cleared the blockage,
verify that the manifold suction tube
connects properly to the nosecone.
4. If the suction remains low, disconnect
the manifold suction tube connector
from the nosecone. Use the tip cleaner
to dislodge blockage from the tubing,
then reconnect the tubing to the
nosecone.
5. Immerse the handpiece tip in sterile
irrigation fluid briefly. This may clear
the blockage.
Blockage in the suction tubing at the 1. Immerse the handpiece tip in sterile
handpiece irrigation fluid briefly. This may clear
the suction tubing.
2. Press the Status button to change to
Standby mode. Use the sterile tip
cleaner to clean out the tip, then put
the tip in irrigating fluid to flush the
tubing.
3. As necessary, disconnect, clean, and
reconnect the suction tubing
connector at the handpiece.
A pinch or kink in the suction tubing Straighten the tubing to remove a kink, or
remove anything that might pinch the
tube.
Low suction at the handpiece A blockage in the suction tubing between 1. Examine the suction tubing along its
tip—continued the handpiece and the suction canister entire length for a blockage.
2. Squeeze the blocked area to loosen it.
3. Immerse the handpiece tip in sterile
irrigation fluid briefly. This may clear
the blockage.
Open port(s) on the suction canister Close any open ports on the suction
canister.
Problem at the CUSA EXcel console Remove the contamination guard and put
suction port a finger in the suction system port. If you
feel no suction, call Integra for assistance.
Suction pinch valve working improperly Check the Lap mode indicator.
• If Lap mode is off, in Run mode the
pinch valve should be open.
• If Lap mode is on, in Run mode the
pinch valve should be open only
when you activate vibration.
If these conditions do not exist, call
Integra for assistance.
The handpiece gets hot Surgeon holding handpiece at tip and flue Hold the handpiece at the nosecone.
The nosecone is loose Large o-ring not installed correctly, or Install the large o-ring in the proper
missing position on the handpiece.
Engineer Troubleshooting
Guidelines
1. Perform the user troubleshooting procedures.
3. Look for obvious causes of the malfunction first, such as loose connections,
broken wires, or discolored/burned components.
4. If a single function is not working, concentrate on that circuit or that part of
the system.
5. If several symptoms are present, locate a circuit that is common to all affected
functions. If the solution is not obvious, check the power supply circuits first.
Flowcharts
Troubleshooting
The following flowcharts present troubleshooting procedures:
• No power
• Handpiece alarm
• Footswitch alarm
• Cooling water alarm
• Low suction
• Low irrigation
• Vibration alarm.
No Power
Integra
Integra Service
Handpiece Alarm
Troubleshooting
Call Integra for
Footswitch Alarm
Troubleshooting
Call Integra Service for
Low Suction
Troubleshooting
Call Integra Service
Low Irrigation
Vibration Alarm
Troubleshooting
Call Integra for
11 Replacement Procedures
In this section:
• Console covers
• System 24 volt power supply
• Ultrasonics and Machine Control printed circuit boards
• Control head components
• Suction control valve
• Suction pump and controller card
• Suction pinch valve
• Irrigation pump head and gear motor
• Handpiece flow sensor
• Cooling water pump tubing
• Cooling water reservoir o-rings
• Fuses.
Warning
Electric Shock Hazard Only trained biomedical engineers and technicians are
authorized to service the CUSA EXcel system.
Electric Shock Hazard Do not touch any exposed wiring or conductive surface while
the CUSA EXcel system is disassembled and energized. Never wear a grounding strap
when working on an energized CUSA system.
Electric Shock Hazard Take appropriate precautions (such as the use of isolated tools
and equipment; use of the “one hand rule,” etc.) when taking measurements or
troubleshooting the CUSA EXcel system.
High Current Hazard Do not touch the ultrasonics PCB heat sink while the
CUSA EXcel system is energized. The heat sink is isolated from ground and can deliver
very high current, resulting in injury.
Notice
If you plan to connect the handpiece for activation, ensure that an I.V. set is available to
supply cooling irrigation solution to the handpiece tip. Otherwise, damage to the tip and/
or handpiece may result.
Console Covers
You can open the left, right, or rear covers on the console to gain access to its
interior. The following procedures describe how to open and re-install each cover.
Figure 11-1.
Right and left sides of the console
Right Side
(includes the
cooling water
reservoir, arm,
Left Side (includes and I.V. Pole)
the system power
switch and the
handpiece
connector
receptacle)
Replacement Procedures
Tools Needed
Phillips head screwdriver
2. Remove two screws (M5 Phillips) from the bottom of the rear cover.
3. Push the rear cover upwards to unhook it from the console, then remove the
cover.
Replacement Procedures
3. Reconnect the footswitch connector to the receptacle on the rear panel.
5. Remove two hex nuts (M4), two lock washers, and two flat washers to release
the power supply chassis from the console.
6. Slide the power supply and its chassis out the left side of the console.
7. Remove the power supply and its chassis from the console.
2. Slide the power supply and its chassis into the console.
3. Replace the two hex nuts (M4), two lock washers, and two flat washers to
fasten the power supply to the console.
4. Connect the wiring harness. Refer to Figure 11-2.
Figure 11-2.
The wiring harness on the system
24 volt power supply
Replacement Procedures
4. Disconnect the cable assemblies from the ultrasonics PCB. Refer to the
following table and Figure 11-3.
Notice
To avoid product damage, do not remove the jumper cable or the connector at J4.
Table 11-1.
Cable connections on the Loc. Connector Wire Color
ultrasonics PCB
J12 40-pin ribbon cable
5. Remove four screws (M5 Phillips) and four lock washers (M5) from the
ultrasonics PCB panel. Refer to Figure 11-3.
When you remove the ultrasonics PCB panel, you will find the heat sink and
cooling fan cables attached to it.
Figure 11-3.
Cables on the ultrasonics PCB
assembly M5 Phillips screw
M5 Phillips screw
Replacement Procedures
J1
J3
J5
J4
J8 J6
J7
J11
J10
J13
M5 Phillips screw
J9 J14
J12
J15
J16
J17
J18
M5 Phillips screw
6. Remove the ultrasonics PCB assembly from the console. Place the ultrasonics
PCB assembly on the floor next to the console.
7. Disconnect the ultrasonics PCB fan assembly by removing the following lead
wires from the 6-pin fan connector housing (removed from J14). Refer to
Figure 11-4.
Table 11-2.
Ultrasonics PCB fan assembly Color Pin
connectors
red 5
black 6
Figure 11-4.
The ultrasonics PCB fan assembly Red wires appear
connections gray in this graphic
3. Replace four screws (M5 Phillips) and four lock washers (M5) on the
ultrasonics PCB panel.
4. On the new ultrasonics PCB assembly, the header at J6 (syphon valve) has a
3.96 mm (0.156 in.) center. The CUSA EXcel console syphon valve lead
wires terminate in a 2-pin connector with either a 3.96 mm (0.156 in.) or a
2.54 mm (0.100 in.) center.
If the connector for the console syphon valve has a 3.96 mm (0.156 in.)
center, connect it to the ultrasonics PCB assembly at J6.
OR
ONLY IF the connector for the console syphon valve has a 2.54 mm
(0.100 in.) center, plug the syphon valve cable assembly adapter into the
connector, then connect the adapter/connector assembly to the ultrasonics
PCB assembly at J6. Refer to Figure 11-5.
Figure 11-5.
Plugging the adapter for the syphon
valve cable assembly into the
connector at J6 on the ultrasonics
PBC
J6
Replacement Procedures
Adapter for syphon
valve cable
assembly
J6 Detail
5. Connect the cable assemblies to the ultrasonics PCB (Refer to the following
table and Figure 11-3).
Table 11-3.
Cable connections on the Loc. Connector Wire Color
ultrasonics PCB
J5 2-pin green, white
J7 12-pin black
Important
When the screws are loose, take 3. Slide the control panel forward far enough to allow disconnecting the
care not to let the control panel following cables:
assembly fall out of the control
head. 40 pin ribbon cable (J3)
20 pin ribbon cable (J5)
10 pin cable (J4)
6 pin cable (J2).
Refer to Figure 11-6.
Figure 11-6.
Disconnecting control panel assembly
cables
J3
J5
Replacement Procedures
J1
J4
J2
1. Attach an ESD wrist strap, then disconnect the 50-pin ribbon cable from the
Machine Control PCB (J1).
Refer to Figure 11-7.
Figure 11-7.
Removing the Machine Control PCB Control panel
from the control panel assembly assembly
Machine
Control PCB
2. Remove five screws (M4 Phillips) from the Machine Control PCB.
3. Remove the Machine Control PCB from the control panel assembly.
4. Connect the 50-pin ribbon cable to the Machine Control PCB (J1).
Notice
To avoid product damage, remove the ESD wrist strap before connecting cables to the
Machine Control PCB.
3. Before sliding the control panel assembly into the control head, connect the
following cables (Refer to Figure 11-6):
40 pin ribbon cable (J3)
20 pin ribbon cable (J5)
10 pin cable (J4)
6 pin cable (J2).
4. Slide the control panel assembly into the control head.
5. Replace four screws (M4 Phillips) and four lock washers (M4), located at the
rear of the control head, that fasten the control panel assembly to the control
head.
Important
While the screws are still loose, 6. Swivel the control head so that the front of the control panel aligns with the
take care not to let the control panel front of the console.
assembly fall out of the control
head. 7. Plug the power cord connector into the wall receptacle.
Replacement Procedures
Control Head Components
The control head contains three replaceable components:
• Machine control PCB
• Control panel overlay
• Display PCB.
The control panel overlay covers the front of the control panel (its fasteners are
accessible inside the control head). The Machine Control PCB and display PCB
(attached to a chassis) constitute two layers in a control panel assembly within the
control head (refer to Figure 11-8). Gaining access to any of these components
involves removing previous layer(s).
Figure 11-8.
The layers of control head
components
Control panel
overlay
Control panel
bezel
Display PCB
Chassis
Table 11-4.
Procedures to access control panel To Access ... You must ...
components
Control panel assembly A: Remove it from the control head
The following procedures describe how to remove and install each individual
component.
Tools Needed
Phillips head screwdriver
3. Swivel the control head so that the front of the control panel is 90° from the
front of the console.
4. Remove four screws and four lock washers (M4 Phillips), located at the rear
of the control head, that fasten the control panel assembly to the control head.
Important
When the screws are loose, take 5. Slide the control panel forward far enough to allow disconnecting the
care not to let the control panel following cables (refer to Figure 11-9):
assembly fall out of the control
head. 40 pin ribbon cable (J3)
20 pin ribbon cable (J5)
10 pin cable (J4)
6 pin cable (J2).
6. Remove the control panel assembly from the control head.
Figure 11-9.
Disconnecting control panel cables
J3
J5
Replacement Procedures
J4
J1
J2
1. Attach an ESD wrist strap, then disconnect the 50-pin ribbon cable from the
Machine Control PCB (J1). Refer to Figure 11-9.
2. Remove five screws (M4 Phillips) from the Machine Control PCB.
3. Remove the Machine Control PCB from the control panel assembly.
2. Remove four screws and four lock washers (M4 Phillips) from the display
PCB chassis.
3. Tilt the display PCB and chassis backward at the top. Lift the display PCB and
chassis from the control panel bezel, being careful to make sure the silicon
buttons clear the bezel.
4. Remove the display PCB from the chassis (refer to Figure 11-11):
Figure 11-10.
Machine
Disconnecting the 50-pin ribbon cable
Control PCB
and removing the Machine Control
PCB
Machine
Control PCB
Figure 11-11.
Removing the Display PCB from the
control head assembly
Replacement Procedures
Control panel
overlay
Control panel
bezel
Display PCB
Chassis
2. Being careful to make sure the silicon buttons clear the bezel, position the
display PCB and chassis in the control panel bezel.
3. Replace the four screws and four lock washers (M4 Phillips) on the display
PCB chassis.
4. Replace the control panel overlay.
3. When the tips of the standoffs rest in the corresponding holes in the control
panel assembly, push on the standoffs with your thumbs until you feel and
hear them snap into place.
Note: Use an adhesive sealant at the top of the control panel overlay.
3. Connect the 50-pin ribbon cable to the Machine Control PCB (J1).
Notice
To avoid product damage, remove the ESD wrist strap before connecting cables to the
Machine Control PCB.
3. Before sliding the control panel assembly into the control head, connect the
following cables:
• 40 pin ribbon cable (J3)
• 20 pin ribbon cable (J5)
• 10 pin cable (J4)
• 6 pin cable (J2).
4. Slide the control panel assembly into the control head.
5. Replace four screws and four lock washers (M4 Phillips), located at the rear
of the control head, that fasten the control panel assembly to the control head.
Important
While the screws are still loose, 6. Swivel the control head so that the front of the control panel aligns with the
take care not to let the control front of the console.
panel assembly fall out of the
control head. 7. Plug the power cord connector into the wall receptacle.
4. Disconnect the suction control valve from the ultrasonics PCB (J7).
Replacement Procedures
6. Remove the left end of the suction pump chamber by removing four screws
(M4 Phillips) and four lock washers (M4). Refer to
Figure 11-12.
7. Remove the right end of the suction pump chamber by removing four screws
(M4 Phillips) and four lock washers (M4). Refer to
Figure 11-12.
8. Remove the suction pump enclosure. Refer to Figure 11-13.
Note: The suction pump enclosure, an L-shaped part, attaches to a baffle
suction pump enclosure. Do not disassemble the two parts.
a. Remove four screws (M4 Phillips) and four lock washers (M4)—two of
each on either end of the enclosure.
b. Slightly lean the enclosure toward the rear of the console so that, as you
remove it, the enclosure will clear other components in the console.
c. Carefully pull the suction pump enclosure out the left side of the console.
Figure 11-12.
Removing the ends from the suction Left end of
pump chamber suction pump
chamber
Right end of
suction pump
chamber
Figure 11-13.
Removing the suction pump enclosure
from the console
Replacement Procedures
1. Disconnect the 3/8 in. inner diameter (ID) suction tube and clamp at the
contamination guard 90° elbow located above the right end of the suction
control valve.
Figure 11-14.
Disconnecting the suction tube at
the contamination guard 90° elbow
2. Remove the cable tie and disconnect the 1⁄8 in. ID tube that connects to the
left end of the control valve.
Figure 11-15.
Disconnecting the suction tube from
the left end of the suction control
valve
3. Pull the strain relief bushing for suction pump motor wires away from the
manifold bracket (a mounting bracket for the suction control valve).
Figure 11-16.
Pulling the strain relief bushing away
from the manifold bracket
Bushing
Manifold bracket
a. Remove two hex bolts (M5) and two lock washers that secure the
manifold bracket to the frame.
b. Carefully lift the manifold bracket (and suction control valve) out the left
side of the console.
Figure 11-17.
Replacement Procedures
Removing the manifold bracket from
the console
a. Remove three screws (M4 socket head cap screws) from the suction
control valve.
Note: A lock washer secures the screw on each end of the assembly, but
no lock washer secures the third screw.
b. Lift the suction control valve from the manifold bracket.
Note: The inlet screen for the suction control valve becomes unattached
when you lift the suction control valve off the manifold bracket.
Figure 11-18.
Removing the suction control valve
from the manifold bracket
Suction control
valve
6. Remove 3/8 in. ID suction tube and clamp from the suction control valve: Set
them aside for re-use.
Note: The new suction control valve does not include this tube and clamp.
Figure 11-19.
Removing the suction hose and clamp
from the suction control valve
Replacement Procedures
2. Attach the suction control valve to the manifold bracket:
a. Position the suction control valve inlet screen on the manifold bracket so
that its three holes align with the three screw holes in the bracket.
b. Position the suction control valve on the manifold bracket so that its three
holes align with the three screw holes in the inlet screen and bracket.
c. Replace three screws (M4 socket head cap screws) in the suction control
valve.
Note: A lock washer secures the screw on each end of the assembly, but no
lock washer secures the third screw.
b. Replace two hex bolts (M5) and two lock washers, securing the manifold
bracket to the frame.
2. Secure the strain relief bushing for suction pump motor wires in the manifold
bracket.
3. Connect the 1⁄8-in. ID tube to the left end of the control valve and secure the
tube with one cable tie.
4. Connect the 3/8 in. suction tube and clamp to the contamination guard 90°
elbow located above the right end of the suction control valve.
Install the Suction Pump Enclosure and Close the Suction Chamber
1. Replace the suction pump enclosure:
a. Carefully insert the enclosure into the left side of the console.
b. Slightly lean the enclosure toward the back of the console so that, as you
slide the enclosure into the console, the enclosure will clear other
components.
c. Replace two screws (M4 Phillips) and two lock washers (M4) on each end
of the enclosure.
2. Replace the right end of the suction pump chamber by replacing four screws
(M4 Phillips) and four lock washers (M4).
3. Replace the left end of the suction pump chamber by replacing four screws
(M4 Phillips) and four lock washers (M4).
4. Return the arm and control head to normal position.
5. Remove the left end of the suction pump chamber by removing four screws
(M4 Phillips) and four lock washers (M4).
6. Remove the right end of the suction pump chamber by removing four screws
(M4 Phillips) and four lock washers (M4).
7. Remove the suction pump enclosure:
Note: The suction pump enclosure, an L-shaped part, attaches to a baffle
suction pump enclosure. Do not disassemble the two parts.
a. Remove four screws (M4 Phillips) and four lock washers (M4)—two of
each on either end of the enclosure.
b. Slightly lean the enclosure toward the rear of the console so that, as you
remove it, the enclosure will clear other components in the console.
c. Carefully pull the suction pump enclosure out the left side of the console.
Replacement Procedures
2. Pull the split bushing restraint on the suction tube away from the manifold
bracket (near the right end of the bracket).
Figure 11-21.
Pulling the split bushing away from
the manifold bracket
3. Disconnect the cables from the suction pump to the suction pump controller
card:
Figure 11-22.
Disconnecting cables from the suction
pump to the suction pump controller
card
Table 11-5.
Suction pump cable connections to the Connector Wire Color
controller card
3-pin, white red, blue, yellow
Replacement Procedures
4. Pull the strain relief bushing for suction pump motor wires away from the
manifold bracket.
Notice
If you are installing the Noise Reduction Kit (NRK) to the system, refer to the
following addendum for instructions:
Addendum to CUSA EXcel® and CUSA EXcel®-8 Service Manuals:
Installing the Noise Reduction Kit (Document # 510I000IE)
Perform the procedures in this addendum in place of the instructions described
on pages 11-32 through 11-35 in this service manual.
5. Remove the suction pump and its bracket mount from the wire rope isolators:
a. Remove four screws (M5 Phillips) and four lock washers (M5).
You need a short Phillips screwdriver for this task.
b. Carefully lift the suction pump and its bracket mount from the wire rope
isolators.
6. Remove the 3/8 in. ID suction tube and clamp from the 90° elbow on the
suction pump: Set them aside for re-use.
Note: Do not remove the split bushing restraint from the tube.
Note: The new suction pump does not include this tube, clamp, or bushing.
Figure 11-23.
Removing the suction tube and strain
relief bushing from the suction pump
and its wires
7. Remove the strain relief bushing from the suction pump wires: Set it aside for
re-use. Refer to Figure 11-23.
Figure 11-24. 8. Remove the suction pump
Replacement Procedures
Removing the suction pump from its from the suction pump
bracket mount bracket mount:
a. Remove four bolts
(M6), four lock washers
(M6), and four nuts
(M6).
b. Lift the pump off the
bracket mount.
a. Position the pump so that it centers on the bracket mount; no part of the
pump body should extend over any edge of the bracket.
b. Replace four bolts (M6), four lock washers (M6), and four nuts (M6).
Figure 11-25.
Attaching the suction pump motor to
its mounting bracket, making sure to
center the pump on the bracket
3. Install attachments:
a. Remove the red plastic cap from the 90° elbow at the pump inlet.
b. Connect the 3/8 in. ID suction tube and clamp to the 90° elbow on the
suction pump inlet.
Note: The split bushing restraint should still be on the tube.
4. Position the strain relief bushing on the suction pump wires 20 cm (8 in.) from
where the wires exit the pump. Crimp the strain relief bushing in place with
pliers.
a. Carefully position the suction pump and its bracket mount on the wire
rope isolators.
b. Replace four screws (M5 Phillips) and four lock washers (M5).
Tip: You need a short Phillips screwdriver for this task.
2. Connect the 3/8 in. suction tube and clamp from the pump to the “T” fitting at
the back of the contamination guard.
3. Push the split bushing restraint on the suction tube into the manifold bracket
(near the right end of the bracket).
4. Push the strain relief bushing for suction pump motor wires into the manifold
bracket.
5. Install the suction pump enclosure:
a. Carefully insert the suction pump enclosure into the left side of the
console.
Tip: When you replace the screws, replace the top screws
(enclosure-to-manifold bracket) first.
b. Replace four screws (M4 Phillips) and four lock washers (M4)—two on
each end of the enclosure.
6. Attach the right end of the suction pump chamber; use four screws
(M4 Phillips) and four lock washers (M4).
7. Attach the left end of the suction pump chamber; use four screws
(M4 Phillips) and four lock washers (M4).
Replacement Procedures
Ready for Suction Pump Controller Card Replacement
At this point, you have removed the suction pump, then re-installed several
components:
• New suction pump
• Suction pump enclosure
• Suction chamber end panels.
The new suction pump is not yet connected to the controller card. The reason is
simple: If you replace the suction pump, you must replace the controller card.
Likewise, if you replace a controller card, you must replace the suction pump.
Important
The cables in the cable clamps 2. Remove the two cable clamps on the bottom of the controller card bracket,
sometimes tangle. When you pull then separate the controller card cable from other cables in the clamps.
the controller card cable away
from the console, be careful to 3. Remove the suction pump controller card from the motor control bracket by
avoid pulling other cables with it. removing four screws (M4 Phillips), four lock washers (M4), and four flat
washers (M4).
Figure 11-26.
Removing the cable clamps and
screws from the suction pump
controller card
1. Attach the new suction pump controller card to the motor control bracket
using four screws (M4 Phillips), four lock washers (M4), and four flat
washers (M4).
2. Replace the two cable clamps on the bottom of the controller card bracket.
Replacement Procedures
Tip: To align the white, 3-pin cable connectors easily, line up the
corresponding segments on the white label that you cut when you removed the
new suction pump from its packaging.
4. Calibrate the suction pump and controller card. For instructions, refer to
Suction Pump in Section 12, Calibration, in this manual.
5. Return the arm and control head to normal position.
3. Open the irrigation pump latch halfway so that the latch lever stands at the 12
o’clock position.
4. Four ball-end retainers hold the irrigation pump bezel in place. Remove the
pump bezel by pulling it straight forward. Refer to Figure 11-27.
2. Disconnect the suction pinch valve from the ultrasonics PCB (J18).
3. Remove the two screws (M4 Phillips) that hold the pinch valve onto the pinch
valve collar.
4. Remove the pinch valve electrical leads from the cable restraints.
Figure 11-27.
Removing the irrigation pump bezel
Figure 11-28.
Removing the suction pinch valve
Replacement Procedures
Pinch valve
collar
3. Replace the two screws (M4 Phillips) that hold the pinch valve onto the pinch
valve collar.
4. Connect the suction pinch valve to the ultrasonics PCB (J18).
3. Open the irrigation pump latch half way so that the latch lever stands at the 12
o’clock position.
4. Four ball-end retainers hold the irrigation pump bezel in place. Remove the
pump bezel by pulling it straight forward. Refer to Figure 11-29.
Figure 11-29.
Removing the irrigation pump bezel
Replacement Procedures
1. Remove two screws (8 - 32 buttonhead) from the front of the irrigation pump.
These screws fasten the pump head to a flat panel.
2. Pull the pump forward to remove it from the panel.
Figure 11-30.
Removing the irrigation pump head
2. View the end of the gear motor coupling, noticing the position of the slot in
the end of the coupling. Position the shaft tang in the pump head to match the
position of the slot in the gear motor coupling.
3. Insert the shaft tang into the slot on the gear motor coupling.
4. Position the pump head on the panel, making sure that the head is flat against
it.
5. Insert two screws (8 - 32 buttonhead), through the front of the pump head.
Important
Do not overtighten the screws. If 6. Set the screws with a 3/32 in. Hex key or Allen wrench.
the screws are too tight, they can
crack plastic parts in the pump 7. Rotate the pump shaft by hand to ensure that the shaft tang has seated properly
head. in the gear motor coupling.
IRRIGATION PUMP
A
B
+24V
C
PCOM +24V
Replacement Procedures
R21 J1
R2 COOLING PUMP
6. After disconnecting the gear motor from the control card, push the bracket
back in the frame and secure it with a minimum of one M4 hex nut.
7. Remove the four screws and four lock washers (M5 Phillips) that attach the
gear motor bracket to the console frame.
8. Pull the gear motor and its bracket forward and remove them from the frame.
9. Remove the four screws (10 - 32 Phillips) that attach the gear motor to the
bracket.
10. Remove the gear motor from the bracket. Refer to Figure 11-32.
Figure 11-32.
Replacing the gear motor/pump
head coupler on the motor drive
shaft
11. Measure the position of the gear motor pump coupler on the motor drive shaft.
Remove the coupling from the shaft by loosening the hex drive set screw.
12. Put the coupling on the new gear motor drive shaft, making sure that the
coupling is in the same position on the new drive shaft as it was on the old
drive shaft.
3. Replace the four screws and four lock washers (10 - 32 Phillips) that attach the
gear motor to the bracket.
4. Put the gear motor and its bracket into the frame, then push them into position.
5. Replace the four screws and four lock washers (M5 Phillips) that attach the
gear motor bracket to the console frame.
6. Remove the hex nut (M4) that secures the control card and bracket to the
frame.
7. Pull the control card bracket far enough from the frame to reconnect the
irrigation gear motor:
Table 11-8.
Irrigation pump control card Wire or connector Terminal
connections
6-pin J1
brown A
red B
orange C
Replacement Procedures
9. Push the control card bracket back in the frame and secure it with four hex
nuts, four washers, and four lock washers (M4).
10. Position the panel on the console frame. Ensure that the tang on the irrigation
pump shaft aligns with the motor shaft coupling.
11. Replace the four screws (M5 Phillips) and four lock washers (M5) that attach
the panel to the frame.
4. Disconnect the flow sensor wiring harness from the ultrasonics board at J5.
5. Remove the handpiece cooling water sensor wiring harness from the cable
restraint located above the sensor.
6. Remove the 1.587 mm (1⁄16 in.) ID tube from the upper end of the flow
sensor.
7. Remove the two screws (M4 Phillips) that attach the flow sensor to the frame.
Lift the flow sensor upwards.
8. Remove the wire tie securing the 3.175 mm (1⁄8 in.) ID tube to the 90° elbow
fitting on the bottom end of the flow sensor.
9. Remove the 3.175 mm (1⁄8 in.) ID tube from the 90° elbow fitting on the
bottom end of the flow sensor.
10. Remove the flow sensor.
NC
COM 1.587 mm
(1/16 in.)
ID Tubing
NO
Bottom end of sensor
Plastic wire tie
Replacement Procedures
4. Lower the flow sensor into place and attach it to the frame using two screws
(M4 Phillips).
5. Apply isopropyl alcohol to the inside surface of the 1.587 mm (1⁄16 in.) tube
and the outside surface of the 1.587 mm (1⁄16 in.) tube fitting on the top end
of the flow sensor.
6. Push the 1.587 mm (1⁄16 in.) ID tube onto the tube fitting on the top end of
the flow sensor. Make sure to push the tube completely onto the fitting. Make
sure, also, that the tube is straight on the fitting.
7. Connect the handpiece cooling water sensor wiring harness to the ultrasonics
board at J5.
8. Secure the handpiece cooling water sensor wiring harness inside the cable
restraint located above the sensor. The cable restraint will contain two water
tubes and the wiring harness.
9. Replace the right side cover and the rear cover.
10. Plug the power cord connector into the wall receptacle.
Replacement Procedures
One packet of silicone lubrication
Instructions for use.
4. Remove the wire ties. Disconnect the pump tubing from the cooling water
tubes at the fittings (2).
5. Remove two screws (8 - 32 Phillips) from the pump head. This releases one-
half of the pump head— an “end bell.” Pull the released end bell from the
console. Refer to Figure 11-34.
6. Remove the tubing from the inside of the released end bell.
Figure 11-34.
Removing the end bell and tubing
from the cooling water pump head
End bell
End bell
From handpiece
connector
Rotor
2. Center the tubing in the right groove and against the first two rollers. Hold the
tubing with your thumb.
3. With the other hand, working counterclockwise, wrap the tubing completely
around the rotor, pushing the tubing into the bell assembly. When the tubing
has wrapped completely around the rotor, hold the second end in place.
4. Position the end bell with the tubing on the end bell in the console. Ensure that
the flat end of the pump drive shaft fits into the slot on the end of the motor
coupler.
5. Replace the two screws (8 - 32 Phillips) that attach the end bells.
Note: If a gap remains between the two end bells after you position them
together, the pump head may pinch or cut the tubing. Rotate the pump shaft
until the gap disappears.
6. After determining that no gap exists between the end bells, tighten the two
screws.
7. Trim the length of the new tubing to reach the cooling water tube fittings.
8. Connect the tubing to the fittings, and replace the wire ties on the fittings. The
kit includes two extra wire ties in case you break or lose one.
9. Replace the left side cover.
10. Plug the power cord connector into the wall receptacle.
Integra offers a cooling water preventive maintenance kit. This kit allows you to
perform two tasks:
• Replace the cooling water pump tubing.
• Replace the o-rings on the cooling water reservoir connectors.
Perform each task every 12 months.
This section tells you how to replace the o-rings on the cooling water reservoir
connectors; the previous section, Cooling Water Pump Tubing, tells you how to
replace the cooling water pump tubing.
3. Remove the o-ring on each male connector on the cooling water reservoir.
Refer to Figure 11-35.
Figure 11-35.
O-rings on cooling water reservoir
connectors
Replacement Procedures
4. Open (tear or cut the end) the packet of silicone lubricant.
5. Apply the silicone lubricant to the two o-rings in the cooling water preventive
maintenance kit.
6. Slide one o-ring over the end and into the groove at the distal end of each male
connector on the cooling water reservoir. Refer to
Figure 11-35.
7. Re-install the reservoir: Slide it into the slot on the console side panel until it
snaps into place.
Fuses
You must change the fuses (located on the rear panel) if a fuse burns out.
Tools needed
You will need a small slotted blade screwdriver.
Procedure
1. Using the screwdriver, turn the fuse cover counter clockwise (about 45°). The
fuse holder pops loose.
2. Remove the fuse holder from the rear panel.
12 Calibration
In this section:
Warning
High Current Hazard Do not touch the ultrasonics PCB heat sink while the
CUSA EXcel system is energized. The heat sink is isolated from ground, and can deliver
very high current, resulting in injury.
3. Put DVM leads between pins 1 and 6 of the output jack on the DC bias power
supply. You will find it on the AC input assembly (facing the rear of the
console, you see it on the left side of the assembly).
4. Turn on the AC Main Switch (rear panel) and the System Power Switch (front
panel).
5. Adjust the potentiometer to 4.7 Vdc (-0 + 0.05).
6. Turn off the System Power Switch (front panel) and the AC Main Switch (rear
panel).
7. Apply a suitable potentiometer locking compound to the adjustment screw of
the potentiometer.
Suction Pump
1. Remove the left cover.
2. Remove the left end panel from the suction pump enclosure.
5. Adjust the Max. speed pot on the suction pump controller card so that the
motor operates at 3200 ± 20 rpm.
6. On the control panel, set the unit in Standby mode.
7. With the digital tachometer, verify that motor speed is greater than 1200 rpm.
8. Apply Torque Seal compound (Integra part number xxxx232 301 176xxxx) to
the Max. speed pot.
9. On the suction pump enclosure, replace the left end panel.
10. On the console, replace the left cover.
Set Up
Before calibrating the motor for the cooling water pump, prepare the cooling
water system:
1. Fill and attach the cooling water reservoir.
3. Turn on the AC Main Switch (rear panel) and the System Power Switch (front
panel).
When you turn on the System Power Switch, the CUSA EXcel system begins
to circulate cooling water through the handpiece. This takes about one minute
to complete. While the system is performing this task, the amber Wait
indicator flashes and the Cooling Water indicator (upper right on the control
panel) illuminates.
When the system turns the Wait and Cooling Water indicators Off, it turns On
the suction pump, the Test button LED, and the Prime button LED. The
cooling water system is ready for calibration.
4. Prime the system: Press the Prime button (blue box on a black button at the
top of the Irrigation display).
Watch for irrigation fluid to drip from the handpiece tip. Priming takes about
Calibration
one minute.
After priming, the system automatically turns the Prime button LED Off, then
goes to the Standby status.
Procedure
3. While the unit is in Run mode, apply the digital tachometer to the cooling
water pump shaft.
4. Adjust the Max. Speed trim pot “R2,” located between J1 and J2 on the
control card for the cooling water motor, to operate the motor speed at the
maximum speed attainable within the range of 61 to 68 rpm.
5. On the CUSA EXcel console, replace the left cover.
13 Repair Policy
In this section:
Repair Policy
Corrugated shipping crate, cover, tray, and ancillary container
Right foam cushion
Left foam cushion
Top lock cushions (2)
Bottom lock cushions (2)
Foam head cushion
• Poly bag 30 in. x 60 in. x 26 in.
• Poly bag 10 in. x 14 in. (1)
• Poly banding, approximately 65 ft
• Banding seals or banding buckles (5)
• Box edge protectors (12)
• Staple gun with 1/2 in. staples
• Pliers (optional).
Procedure
1. Position the pallet with the ramp down and all other materials removed.
5. Lock the front (brake) casters and the rear (directional) casters by pushing
each lock lever downward.
Repair Policy
c. Through the footswitch bracket on the bottom of the console
8. Attach the right (5) and left (6) foam cushions to the console.
Attach the four interlocking foam pieces (1–4) from the foam cushion around
the console (refer to the following figure).
Caution
To prevent the ramp from falling and causing injury, be sure to hold the ramp in the up
position while stapling the corrugated tab that secures it to the crate.
Repair Policy
13. Secure the crate closed by locking the three plastic clips into the slots on the
side of the corrugated crate. Refer to the next figure.
a. With the clip oriented so that the tab is on its bottom edge, insert the clip
into the slot. Push hard enough that the flange on the clip rests firmly on
the outside of the left front panel and the leading edge of the clip is inside
the corrugated crate.
b. Push the horizontal bars inside the clip toward the crate until the bars lock
into place.
14. Pack the CUSA EXcel footswitch into its original packaging, and seal the
packaging with tape.
15. Place the sealed footswitch
packaging into the
corrugated tray.
Note: If returning a
handpiece, secure it into its
original packaging, then
place the handpiece
packaging into the
corrugated tray.
Install the tray in the top of
the corrugated crate.
16. Install the cover on the
corrugated crate.
Repair Policy
Package each handpiece in a separate packaging container.
In this section:
Replacement Parts
Handpiece Cooling
Table 14-1.
Handpiece cooling replacement Reference Integra
parts Designator Description Part Number
Irrigation
Table 14-2.
Irrigation replacement parts Reference Integra
Designator Description Part Number
IV Pole 223400733
Miscellaneous
Table 14-3.
Miscellaneous replacement parts Reference Integra
Designator Description Part Number
Suction
Table 14-5.
Suction replacement parts Reference Integra
Designator Description Part Number
Electronic Parts
Table 14-6.
Printed circuit board spares Reference Integra
Designator Description Part Number
Interconnection Cables
Table 14-7.
Interconnection Cables Reference Integra
Designator Description Part Number
Reference Integra
Designator Description Part Number
Mechanics
Table 14-8.
Mechanics Reference Integra
Designator Description Part Number
FETs
Table 14-9.
Ultrasonics board parts—FETs Reference Integra
Designator Description Part Number
Integrated Circuits
Table 14-10.
Ultrasonics board parts—integrated Reference Integra
circuits Designator Description Part Number
U8 LM78L05 210300109
Connectors
Table 14-11.
Ultrasonics board parts—connectors Reference Integra
Designator Description Part Number
J5, 10, 11, 18 Header, 2 PIN, 0.100 in. centers, Lock 208200389
Miscellaneous
Table 14-12.
Ultrasonics board parts— Reference Integra
miscellaneous Designator Description Part Number
Warranty
A
1. Warranty.
INTEGRA LIFESCIENCES CORPORATION and its wholly owned subsidiaries
("Integra") warrant to Integra authorized distributors and the original purchaser only that
each new Integra Cusa Excel Ultrasonic Surgical Aspirator (hereinafter the Equipment or
the product) is free from manufacturing defects in material and workmanship under normal
use and service for a period of one (1) year (except as otherwise expressly provided as to
accessory items) from the date of invoice by Integra (or its authorized distributor) to the
original purchaser, but in no event beyond the expiration date stated on any product
labeling (hereinafter the Warranty Period). For purposes of products sold by Integra
through an authorized distributor of Integra, "original purchaser" shall include the
purchaser of Integra products to whom the distributor first sells the product. The original
purchaser is hereinafter referred to as Customer.
1.1. Coverage. During the Warranty Period, Integra shall provide free-of-charge
service and maintenance consistent with the provisions of Section 3 of this Warranty,
so that the Equipment conforms to the specifications defined in the Cusa Excel
Ultrasonic Surgical Aspirator Operator’s Manual, as such Operator’s Manual may be
modified by Integra from time to time (the “Specifications”).
1.2. Exclusions. The Warranty shall not apply in any manner to service or maintenance
of the Equipment, or to replacement of its parts, with respect to:
(i) use of Equipment with any tips, flues, and manifold tubing sets and
accessories other than those manufactured by Integra LifeSciences;
(ii) defects arising out of materials or parts provided, modified or designed by
anyone other than an authorized Integra service agent (the Integra “Service
Agent”);
(iii) defects emanating from improper or negligent installation, storage or use of
the Equipment or any component thereof, including but not limited to operating
the Equipment not in accordance with instructions provided in the Operator’s
Manual;
(iv) defects arising from improper or negligent cleaning or sterilization methods or
improper maintenance of the Equipment;
(v) defects resulting from repairs or service of the Equipment provided other than
by Integra or its authorized representatives;
4. Quality Control.
4.1. Customer shall maintain reasonable standards of quality control, operations,
procedures, safety testing and inspection of Equipment to ensure that unnecessary
service or maintenance is not required hereunder.
4.2. Customer shall provide a technical counterpart to Integra's Service Agent for
assistance in Integra's telephonic diagnosis of the malfunction with the Equipment.
Customer shall reasonably accept Integra's determination whether a repair or service is
an in-warranty repair or an out-of-warranty repair.
Warranty
SERVICE AGENTS WITH RESPECT TO THE QUALITY, PERFORMANCE AND
OPERATION OF THE EQUIPMENT, WRITTEN OR ORAL, EXPRESS OR
IMPLIED, AND WHETHER OR NOT ATTRIBUTABLE TO SERVICE
PERFORMED PURSUANT TO THE WARRANTY. ALL OTHER
REPRESENTATIONS OR WARRANTIES OF INTEGRA OR ITS
REPRESENTATIVES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
EQUIPMENT OR THE SERVICES, DIAGNOSIS, ADVICE, ASSISTANCE OR
PARTS TO BE TENDERED PURSUANT TO THE WARRANTY, INCLUDING,
WITHOUT LIMITATION, THOSE OF MERCHANTABILITY AND FITNESS FOR
A PARTICULAR PURPOSE, ARE HEREBY EXPRESSLY DISCLAIMED. IN NO
EVENT SHALL INTEGRA, ITS ASSIGNEES OR SERVICE AGENTS BE LIABLE
FOR LOSS OF USE, REVENUE OR PROFIT OR ANY OTHER INDIRECT,
INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, SPECIAL OR OTHER
DAMAGES, WHETHER ARISING IN CONTRACT OR IN TORT, BY VIRTUE OF
THE WARRANTY OR ANY PERFORMANCE OR BREACH BY INTEGRA, ITS
ASSIGNEES OR SERVICE AGENTS HEREUNDER OR PURSUANT HERETO.
5.2. Customer agrees that, notwithstanding the technical assistance provided pursuant
to the Warranty by Integra or its representatives, Customer shall be fully and solely
responsible for all treatments performed or attempted with the Equipment. INTEGRA
MAKES NO REPRESENTATION OR WARRANTY AS TO THE EFFICACY OF
THE EQUIPMENT OR OF THE TECHNICAL ASSISTANCE TO BE RENDERED
BY INTEGRA, ITS ASSIGNEES OR SERVICE AGENTS, FOR PURPOSES OF
THE PARTICULAR TREATMENT THAT CUSTOMER INTENDS TO PERFORM
FOR THIRD PARTIES. Moreover, Integra disclaims any liability with respect to the
efficacy of the Equipment or of said technical assistance or with respect to any claims
by third parties related to any treatment performed by Customer.
5.3. THIS INTEGRA LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, AND OF ALL OTHER
OBLIGATIONS OR LIABILITIES ON INTEGRA'S PART OR THE PART OF ITS
DISTRIBUTORS, AND INTEGRA NEITHER ASSUMES NOR AUTHORIZES
ANY REPRESENTATIVE OR OTHER PERSON TO ASSUME FOR IT ANY
OTHER LIABILITY IN CONNECTION WITH INTEGRA'S PRODUCTS.
INTEGRA DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF
FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION OR WARRANTY
OF QUALITY AS WELL AS ANY EXPRESS OR IMPLIED WARRANTY TO
PATIENTS. No warranty or guarantee may be created by any act or statement nor may
this Standard Warranty be modified in any way, except as a result of a writing signed
by an officer of INTEGRA. These limitations on the creation or modification of this
warranty may not be waived or modified orally or by any conduct.
5.4 IN NO EVENT SHALL INTEGRA AUTHORIZED DISTRIBUTORS BE
LIABLE TOWARDS CUSTOMER FOR ANY INCIDENTAL, INDIRECT,
CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE
ACQUISITION OR USE OF ANY INTEGRA PRODUCT. Further, this warranty
shall not apply to, and INTEGRA authorized distributors shall not be responsible
towards Customer for, any loss, arising in connection with the purchase or use of any
INTEGRA product that has been repaired by anyone other than an authorized
INTEGRA service representative or altered in any way so as to affect its stability or
reliability, or which has been subject to misuse, negligence or accident, or which has
been used otherwise than in accordance with the instructions furnished by INTEGRA.