Integra®

CUSA® Excel/CUSA® Excel+ User’s Guide

Integra® CUSA® Excel/CUSA® Excel+
Ultrasonic Surgical Aspirator System
USER’S GUIDE

Integra ® CUSA ® Excel /CUSA ® Excel+ User’s Guide

Integra LifeSciences (Ireland) Limited
M IDA Business and Technology Park
Sragh
Tullamore, County Offaly, Ireland

Distributed By:
Integra LifeSciences Corporation
Plainsboro, NJ 08536 USA

For more information or to place an order, please contact:

Integra 311 Enterprise Drive, Plainsboro, NJ 08536
■

USA and Canada: 800.997.4868 609.936.5400 (Outside USA)

■

888.980.7742 (Fax)
integralife.com

Integra, the Integra logo, CUSA and CUSA Excel are registered trademarks of Integra
LifeSciences Corporation or its subsidiaries in the United States and/or other countries.
© 2019 Integra LifeSciences Corporation. All Rights Reserved.
60903711, Rev E 0868211-2
CUSA® Excel/CUSA® Excel+
Ultrasonic Surgical Aspirator
System

User’s Guide
CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator
System User’s Guide
This User’s Guide and the equipment it describes are for use only by qualified
medical professionals trained in the particular technique and surgical procedure to
be performed. It is intended as a guide for using the CUSA® Excel and CUSA®
Excel+ Ultrasonic Surgical Aspirator System only.ystem.stem only.
Equipment Covered in this Manual
The CUSA Excel refers to the following product models: CUSA Excel and
CUSA Excel-8. Both product models utilize 23 kHz and 36 kHz handpieces.
The CUSA Excel+ refers to the product models: CUSA Excel 2 and CUSA Excel-9.
The system incorporates graphic modifications of the logo design and color of the
top cover of the system. The CUSA Excel+ System utilizes the same CUSA Excel
family of handpieces.

Caution
Y Federal (USA) law restricts this device to sale by or on the order of a physician.

Trademark Acknowledgements
Integra, the Integra logo, CUSA, CUSA Excel and Tissue Select are registered
trademarks of Integra LifeSciences Corporation or its subsidiaries in the United
States and/or other countries.
MacroTip, MicroTip, PrecisionTip, SaberTip, CEM and ShearTip are trademarks of
Integra LifeSciences Corporation or its subsidiaries.
Ajax is a registered trademark of Colgate-Palmolive Company.
Comet is a registered trademark of the Spic and Span Company.
Klenzyme is a registered trademark of Steris Corporation.
Enzol is a registered trademark of Johnson & Johnson.
All other trademarks and trade names are the property of their respective owners.

Manufacturer:
Integra LifeSciences (Ireland) Limited
IDA Business & Technology Park
Sragh
Tullamore, County Offaly, Ireland

Distributed By:
Integra LifeSciences Corporation
Plainsboro, NJ 08536 USA; 1-800-997-4868

© 2019 Integra LifeSciences Corporation. All Rights Reserved. Contents of this

0086 publication may not be reproduced in any form without the written permission of
Integra.
Patent Information
U.S. Patents 6,499,358; 6,602,227; 7,204,825; 8,118,823; 8,142,460; 8,518,066;
9,421,027; additional patent(s) pending.

ii CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Preface
This User’s Guide describes how to use the Integra® CUSA® Excel/CUSA® Excel+
Ultrasonic Surgical Aspirator System. It presents the Integra
CUSA Excel/CUSA Excel+ as a system that includes a console, handpieces, and
accessories. It describes:
• The System and its functions.
• The Console, its subsystems, and its components.
• The Handpiece and its components.
• How to setup and use the console.
• How to assemble and use the handpiece with the system.

Notice
A technical description of the CUSA Excel/CUSA Excel+ System is provided in
the CUSA Excel/CUSA Excel+ System Ultrasonic Surgical Aspirator System
Service Manual. The Service Manual is not supplied with the system as it is
intended to be used only by Integra service personnel and/or their agents.

System Features
The CUSA Excel/CUSA Excel+ System includes several important features:
• 23 kHz (straight and angled) and 36 kHz (straight) handpieces
• A large variety of 23 kHz and 36 kHz surgical tips that attach to the
handpieces:
 Sterile, single-use tips
 Nonsterile, extended-life tips
• Tissue Select® feature, which increases the selectivity of the surgical tip,
allowing greater control and precision.

Organization
This User’s Guide is organized into these sections:
• Section 1: Patient and Operating Room Safety presents the Warnings,
Cautions and Notices that you need to read and understand to operate the
CUSA Excel/CUSA Excel+ System with maximum safety.
• Section 2: Introduction to the CUSA Excel/CUSA Excel+ System gives an
overview of the console and its functions, and an overview of handpieces and
related accessories.
• Section 3: Console Components describes the console, its subsystems and its
components.
• Section 4: Control Panel Display and Functions describes the control panel
display, the signs and symbols on the control panel and the control panel
behavior during system startup and operation.
• Section 5: Setting Up the CUSA Excel/CUSA Excel+ System explains how to
prepare the console and its subsystems for use in surgery. It includes the
handpiece assembly options; how to prepare the console for startup, connect
and test the handpiece, connect the irrigation and suction systems; how to
prime the system, adjust settings, and switch to the Run mode.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide iii
 • Section 6: Using CUSA Excel/CUSA Excel+ Console Controls describes the
control panel buttons and functions. It also includes guidelines on using the
Tissue Select feature.
• Section 7: Handpiece Components presents the items that compose an
assembled handpiece, their physical characteristics, and the function of each
item. It also presents items that, although not a part of the handpiece itself, are
essential in assembling a handpiece or preparing it for sterilization.
• Section 8: Assembling the Handpiece in a Nonsterile Area provides step-by-
step instructions for assembling the handpiece and preparing it for sterilization.
• Section 9: Sterilizing Handpieces and Accessories provides the sterilization
parameters you need to ensure that the handpiece is ready for use in the
sterile field.
• Section 10: Completing Handpiece Setup in the Sterile Field describes how to
complete the handpiece assembly in the sterile field.
• Section 11: Assembling or Changing Tips in the Sterile Field describes how to
attach or change sterile tips in the sterile field.
• Section 12: Shutting Down the CUSA Excel/CUSA Excel System explains
how to turn off the system; disconnect suction tubing, irrigation tubing, and the
handpiece; and how to clean the console.
• Section 13: Disassembling Handpieces describes how to disassemble and
clean the handpiece, and how to clean the tip torquing set.
• Section 14: Troubleshooting the CUSA Excel/CUSA Excel+System offers
suggestions for problem solving before or during surgery.
• Section 15: Maintaining the CUSA Excel/CUSA Excel+System describes the
maintenance tasks that help to keep the console and handpieces operating as
intended.
• Appendix A: Technical Specifications provides detailed technical information.
• Appendix B: Sterilization Validation provides information on the sterilization
validation procedure.
• Appendix C: Warranty provides warranty information.

Intended Uses
When you receive your CUSA Excel/CUSA Excel+ System, we recommend that
you read and understand all of this User’s Guide before using the system. Also,
use the guide for:
• Reference - When you need specific information on a task. Once you are
familiar with the system, use the “Quick Reference” cards (located behind the
Control Panel).
• Training - When training new personnel to use the system.Conventions Used
in this Guide
To draw immediate attention to matters of importance, this guide presents
Warnings, Cautions, Notices, and Important information.

Warning
Indicates a potentially hazardous situation that, if not avoided, could result in
serious injury or death, or product damage.

iv CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

 Caution
Indicates a hazardous situation that, if not avoided, could result in minor or
moderate injury, or product damage.

Notice
Indicates a hazard that may result in product damage.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide v

Notes

vi CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Table of Contents
Section 1. Patient and Operating Room Safety 1-1
Indications for Use 1-1
Intended Users 1-2
Safety Information 1-2
Warnings, Cautions, and Notices 1-3
Classification and Console Symbols 1-9

Section 2. Introduction to the System 2-1

For Your Information 2-1
About the CUSA Excel/CUSA® Excel+ System
®
2-2
About the Handpieces 2-4
About the Tissue Select® Feature 2-6
Sterilization of Handpieces and Accessories 2-9

Section 3. Console Components 3-1

For Your Information 3-1
About the Console and Structural Features 3-2
Console Body – Front Panel 3-4
Console Body – Side Panel 3-7
Console Body – Rear Panel 3-9
About the Power Switches 3-13

Section 4. Control Panel Display and Functions 4-1

For Your Information 4-1
About the Control Panel Display 4-2
Signs and Symbols on the Excel8 and Excel9 Control Panel 4-10
Signs and Symbols on the Excel and Excel 2 Control Panel 4-12
Understanding the Control Panel at System Startup 4-13

Section 5. Setting Up the System 5-1

For Your Information 5-1
Quick Reference – Setup 5-2
Handpiece Assembly Options 5-3
Preparing the System for Startup 5-4
Turning On the System 5-7
Connecting the Suction Tubing 5-7
Connecting the Irrigation Tubing 5-9
Testing the Handpiece 5-11
Testing the Alarm Tone 5-12
When the Surgeon Is Ready 5-13

Section 6. Using the Console Controls 6-1

For Your Information 6-1

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide vii
 Adjusting Setpoint Values 6-1
Changing Functions 6-3
Using the Tissue Select Feature 6-4
Using Other Features 6-6

Section 7. Handpiece Components 7-1

For Your Information 7-1
Components of Assembled Handpieces 7-2
Additional Handpiece Components 7-5

Section 8. Assembling the Handpiece in a Nonsterile Area 8-1

For Your Information 8-1
Items Needed for Handpiece Assembly 8-2
Attaching the Tip to the Connecting Body 8-4
Putting On the O-Rings 8-6
Clipping the Manifold Tubing to the Handpiece Cable (Optional) 8-6
Packaging the Handpiece for Sterilization 8-7

Section 9. Sterilizing Handpieces and Accessories 9-1

For Your Information 9-1
Sterilization Parameters 9-1
Sterilizing the Handpiece with Steam 9-3

Section 10. Completing Handpiece Setup in the Sterile Field 10-1

For Your Information 10-1
Quick Reference – Setup 10-2
Completing the Handpiece Assembly 10-2

Section 11. Assembling or Changing Tips in the Sterile Field 11-1

For Your Information 11-1
Items Needed to Change Tip in Sterile Field 11-2
Assembling the Tip 11-5
Disassembling Handpiece to Change Tips in the Sterile Field 11-10
Disassembling Handpiece After the Surgical Procedure 11-13
Resterilizing the Handpiece 11-14
Resterilizing the Sterilizable Torque Base 11-14
Packaging the Handpiece for Sterilization 11-15
Packaging the Base for Sterilization 11-16
Sterilize the Handpiece and Base 11-17

Section 12. Shutting Down, Disconnecting and Cleaning

the Console 12-1
Shutting Down the System 12-2
Disconnecting Suction Tubing, Irrigation Tubing, and the Handpiece 12-3
Cleaning the Console 12-5

viii CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Section 13. Disassembling and Cleaning Handpieces 13-1
For Your Information 13-1
Disassembling the Handpiece 13-2
Cleaning the Handpiece 13-4
Permitted Number of Reprocessing Cycles for Handpieces when Cleaned with an
Automatic Washer 13-6
Cleaning the Tip Torquing Set 13-7

Section 14. Troubleshooting the System 14-1

For Your Information 14-1
Responding to Alarms 14-2
General Troubleshooting 14-5

Section 15. Maintaining the System 15-1

For Your Information 15-1
Quick Reference 15-2
Handpiece Maintenance 15-3
Sterilizer Case Maintenance 15-4
Handling and Transporting of the System 15-4
Storage of the System and Accessories 15-5
Disposal of the Equipment 15-5
Return Equipment for Service 15-5
Integra Service Centers 15-7

Appendix A. Technical Specifications A-1

Console Dimensions A-1
Console Subsystems A-2
Electrical Requirements A-3
Environment A-4
Voluntary Standards A-5
Handpieces A-11
Tip Specifications A-11

Appendix B. Sterilization Validation B-1

Validation of Steam Sterilization Parameters B-1

Appendix C. Warranty C-1

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide ix

Notes

x CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

List of Figures
Figure 3-1. Console – Front View 3-2
Figure 3-2. Console Body – Front Panel 3-4
Figure 3-3. Console Body – Side Panel 3-7
Figure 3-4. Console Body – Rear Panel 3-9
Figure 3-5. Console Body – Rear Panel Continued 3-10
Figure 4-1. Control Panel for Excel8 and Excel9 models 4-2
Figure 4-2. Control Panel for Excel and Excel 2 model 4-3
Figure 4-3. Control Panel – Excel8 and Excel9 model (status indicators and
setpoint adjustment) 4-6
Figure 4-4. Control Panel – Excel and Excel 2 model (status indicators and
setpoint adjustment) 4-7
Figure 5-1. The assembled suction system 5-8
Figure 5-2. The assembled irrigation system 5-10
Figure 7-1. The components of a handpiece 7-2
Figure 7-2. Tip torquing base and torque wrench for use when changing tips in
the nonsterile field 7-5
Figure 7-3. The sterilizable torque bases for use when changing tips in the
sterile field 7-6
Figure 7-4. The sterile torque wrench for use when changing tips in the sterile
field 7-7
Figure 7-5. The 23 kHz CUSA Excel/CUSA Excel+ handpiece sterilizer
case 7-8
Figure 8-1. The items you need to assemble a handpiece: handpiece,
nosecone, and tip pack 8-2
Figure 8-2. Tip torquing base and torque wrench (for use in non-sterile
field) 8-3
Figure 8-3. Manifold tubing 8-3
Figure 8-4. The sterilizer case 8-7
Figure 8-5. The handpiece and connector secured into the sterilizer tray 8-8
Figure 11-1. The sterilized handpiece 11-2
Figure 11-2. The sterilized standard nosecone 11-3
Figure 11-3. Sterile tip/flue pack contents. The tip cleaner is inside the flue. 11-3
Figure 11-4. Sterilizable tip torquing base 11-4
Figure 11-5. Sterile torque wrench (23 kHz or 36 kHz) 11-4
Figure 11-6. Sterile manifold tubing 11-4
Figure 11-7. The handpiece and connector secured into the sterilizer tray 11-18
Figure 15-1. Replacing o-ring on the handpiece connector water prongs 15-3

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide xi

Notes

xii CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 1
Patient and Operating Room
1

Safety

In this section:

• Indications for Use, page 1-1

• Intended Users, page 1-2
• Safety Information, page 1-2
• Warnings, Cautions, and Notices, page 1-3
• Classification and Console Symbols, page 1-9

Indications for Use

The CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System is
indicated for use in these surgical procedures where fragmentation,
emulsification and aspiration of soft and hard tissue is desirable:
• Neurosurgery
• Gastrointestinal and affiliated organ surgery
• Urological surgery
• General surgery
• Orthopedic surgery
• Gynecological surgery
• Laparoscopic surgery

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-1
Intended Users

Warning
The CUSA Excel/CUSA Excel+ System cannot be used in an MRI (Magnetic
Resonance Imaging) environment.

Warning
No modification of this equipment is allowed.

Notice
When you receive the CUSA Excel/CUSA Excel+ System and accessories, if
any component is damaged, contact your Integra service representative for
assistance. If the packaging for a sterile accessory is damaged, do not use the
sterile accessory.

Intended Users
The intended users of this guide and the equipment it describes are
qualified medical professionals who are trained in the particular surgical
technique and surgical procedure to be performed, and trained in the use
of this equipment. The CUSA Excel/CUSA Excel+ System should only be
used in a surgical environment by qualified medical professionals.

Warning
It is the responsibility of the Healthcare Facility to ensure that intended users of
CUSA Excel/CUSA Excel+ System are appropriately trained in the use of this
equipment.

Safety Information
The safe and effective use of ultrasonic surgery depends to a large degree
on factors solely under the control of the operator. Only medical
professionals that are properly trained in the use of ultrasonic equipment
should operate the CUSA Excel/CUSA Excel+ System. It is important that
medical professionals read, understand, and follow the operating
instructions supplied with this equipment.
Before starting any surgical procedure, medical professionals should be
familiar with the medical literature, complications, and hazards of using
ultrasonic surgery in that procedure.

1-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Warnings, Cautions, and Notices

Warnings, Cautions, and Notices

To promote the safe use of the CUSA Excel/CUSA Excel+ System, this
section presents the warnings, cautions, and notices that appear
throughout this User’s Guide. To operate this equipment with maximum
safety, it is important to read, understand, and follow the instructions in
these warnings, cautions, and notices.

Patient and Operating Room Safety

Warning

The CUSA Excel/CUSA Excel+ System cannot be used in an MRI (Magnetic

Resonance Imaging) environment.

No modification of this equipment is allowed.

It is the responsibility of the Healthcare Facility to ensure that intended users of

CUSA Excel/CUSA Excel+ System are appropriately trained in the use of this
equipment.

Notice
When you receive the CUSA Excel/CUSA Excel+ System and/or accessories, if
any component is damaged, contact your Integra service representative for
assistance.

Introduction to the System

Warning

Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed or
re-used this may result in the infection of patient (or patient specimen) through
cross-contamination, as well as would incur the risk of modifying the properties
and performance of the device, and of increasing the likelihood of complications
and/or undesirable effects. Once used, devices must be disposed of in
accordance with hospital policies.

Only use Integra handpieces and accessories with the CUSA

Excel/CUSA Excel+ System. Non-Integra handpieces and accessories are not
supported.

Caution
Read the instructions, warnings, cautions, and notices provided with the
CUSA Excel/CUSA Excel+ System before use. Otherwise injury to the patient or
user or equipment damage may result.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-3
Warnings, Cautions, and Notices

Console Components
Warning

Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to use
the system may result in injury to the patient and/or surgical personnel, or
equipment damage.

To avoid injury to surgical personnel, keep fingers away from the suction pinch
valve.

TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE

CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

The power cord on this product contains lead, a chemical known to the State of
California, USA, to cause cancer, and birth defects or other reproductive harm.
Wash hands after handling. The power cord complies with the DIRECTIVE
2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8
June 2011on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (recast).

When you connect the handpiece to the console, the handpiece becomes a
functional surgical device.

Setting Up the System

Warning

When the handpiece is connected to a CUSA Excel/CUSA Excel+ System that is

powered on, but the handpiece is not in use, keep the handpiece away from the
patient. Place the handpiece on a sterile, flat, dry, nonconductive, and highly
visible surface.

Inadvertent contact between handpiece accessories and the patient may result in
burns.

Do not use a damaged handpiece with the CUSA Excel/CUSA Excel+

System.This may result in injury to the patient or surgical personnel.

Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to

use the system may result in injury to the patient and/or surgical personnel, or
equipment damage.

To avoid injury to surgical personnel:

When closing the irrigation pump latch, keep fingers away from the area between
the V-shaped tubing retainers.
If the pump latch is open, keep fingers away from the pump rollers.

To avoid injury to surgical personnel, keep fingers away from the suction pinch
valve.

When you connect the handpiece to the console, the handpiece becomes a
functional surgical device.

The handpiece and handpiece accessories must be sterile before surgical use.

1-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Warnings, Cautions, and Notices

Warning

Touching of the tip of the handpiece by the operator, while the handpiece is
powered on, can result in personal injury.

When the handpiece is powered on, contact of the tip with a hard surface (e.g. a
metal instrument, tray, staples, clips, instruments, etc) may damage the tip of the
handpiece and require replacement before use.

CUSA Excel tips utilize silicone flues. Compressing the flue against the side of
the vibrating surface along the length of the tip can cause excessive heating and
potential hazard to adjacent tissue, such as burns.

Excessive loading of CUSA Excel tips at the surgical site can induce heating due
to vibration and acoustic power transmissions. Thermal management of the
surgical site with the aid of the appropriate irrigation and aspiration settings is
essential.

Avoid excessive lateral loading of CUSA Excel tips.

Avoid contacting bone with the CUSA Excel tips (excluding SaberTip™).

Caution

When you test the handpiece, 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.

During surgery, under maximum loading conditions, the

CUSA Excel/CUSA Excel+ console is suitable for ultrasonics activation times of
10 minutes on, 5 minutes off.

Sharp edge at the handpiece connection point.

Make sure that the irrigation tubing centers between the V-shaped tubing
retainers before you close the pump latch. Otherwise, the pump latch will pinch
the tubing, preventing the flow of irrigation fluid.

Before surgery, apply the brakes locks to all wheels on the console to stop the
wheels from rolling.

Notice

To prevent fluid flowing into the vacuum line, only use a canister that has a non-
return valve.

During surgery, do not allow the handpiece tip to touch metal objects such as
staples, clips, instruments, etc. Handpiece tip damage will result.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-5
Warnings, Cautions, and Notices

Using the Console Controls

Warning
Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to
use the system may result in injury to the patient and/or surgical personnel, or
equipment damage.

Handpiece Components
Warning
Do not use the sterile wrench for more than one surgical procedure.

Assembling the Handpiece in a Nonsterile Area

Warning
Turning the torque wrench further clockwise will damage the handpiece.

Caution

Do not assemble the nonecone to the handpiece until you have sterilized the
handpiece.

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 sterilize the C5600 tip torquing base or the associated the torque wrench
because it destroys the lubrication in the torquing mechanism, resulting in
product damage.

Completing Handpiece Setup in the Sterile Field

Notice
Retaining a spare handpiece in the sterile field is highly recommended.

Assembling or Changing Tips in the Sterile Field

Warning

The handpiece and handpiece accessories must be sterile before surgical use.

Before use, sterilize the sterilizable torque base in the sterilizer tray.

Turning the torque wrench further clockwise will damage the handpiece.

Caution
To avoid product damage, NEVER hold the handpiece in your hand while
using the torque wrench to tighten or loosen the tip.

1-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Warnings, Cautions, and Notices

Shutting Down, Disconnecting and Cleaning the System

Warning
Electric Shock Hazard – Always unplug the CUSA Excel/CUSA Excel+ System
before cleaning it.
Sharp edge at the handpiece connection point.

Notice

Do not disconnect the handpiece until the control panel goes completely blank.
Otherwise, product damage may result.

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 because it will cause
discoloration.

Do not allow fluids to enter the console.

Disassembling Handpieces
Caution

To avoid product damage, NEVER hold the handpiece in your hand while using
the torque wrench to tighten or loosen the tip.

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 washers
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 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

Maintaining the System

Notice

Do not clean the sterilizer case with abrasives. Product damage will result.

To avoid product damage, use proper packaging materials and packing

procedures when preparing the console for shipment. Failure to return product in
this manner may void the warranty and/or damage the product. Contact Integra
for details.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-7
Warnings, Cautions, and Notices

Appendix A. Technical Specifications

Warning

Explosion Hazard – Do not use the CUSA Excel/CUSA Excel+ System in the
presence of flammable anesthetics or any potentially explosive or flammable
atmosphere.

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.

TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE

CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

The console must be earthed and therefore it MUST only be fitted with a 3-pin
plug, or a 2-pin plug that has an integral earth grounding connection. Mains plug
type and construction MUST comply with Legal requirements within country of
installation. Only Integra Service personnel or Integra authorized representatives
or agents can change the mains plug on the console.

1-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Classification and Console Symbols

Classification and Console Symbols

Symbol Description

Console Symbols

Warning: When you connect the handpiece to the console, the

handpiece becomes a functional surgical device.

Warning: Dangerous Voltage

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.

Follow Instructions for Use

Cooling Reservoir: Do not fill the Cooling Reservoir with tap

water or saline solution. Use distilled water only.

Do not insert fingers. Pinch Point can cause injury.

Warning
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.

Consult Instructions for Use

Equipotentiality: Connect equipotential ground cable here.

Protective earth (ground)

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-9
Classification and Console Symbols

Symbol Description

Class I Equipment (IEC 601-1)

Accessible conductive parts cannot become live in the event of a
basic insulation failure because of the way in which they are
connected to the protective earth conductor Type BF Applied
Part Equipment (IEC 601-1)
The CUSA Excel/CUSA Excel+ System console provides a high
degree of protection against electric shock, particularly regarding
allowable leakage currents. It is type BF isolated (floating)
output. The handpiece, cord and tip are applied parts.
IPX - 8 (IEC 529, UL60601) Footswitch
IPX - 0 (IEC 529, UL60601) Console
The CUSA Excel/CUSA Excel+ System footswitch includes
protection against the effects of continuous immersion in water.

ON (power)
Applies power at the AC Main Switch and the System Power
Switch.

OFF (power)

System Power Off / Standby

When you turn off the System Power Switch, the system
automatically drains water from the cooling water system and
deactivates other system components. It also maintains power to
the logic circuitry to monitor the System Power Switch position.

Fuse Replacement
Indicates the location of the fuse drawer on the rear panel.

Volume Control
VOLUME

Footswitch Connector

Manufacturer

1-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Classification and Console Symbols

Symbol Description

Catalogue Number
REF
Serial Number
SN
Please dispose of in accordance with local regulations for the
collection or disposal of waste electrical and electronic
equipment.

Caution: Federal (USA) law restricts this device to sale by or on

the order of a physician.
Y

Temperature Limitation: Indicates upper and lower temperature

limits

Humidity Limitation: Indicates upper and lower humidity limits

Recyclable material

UL Certification used in conjunction with the INMETRO Mark of

Segurança the National Institute of Metrology, Standardization and Industrial
Quality in Brazil.

GOST R Russian mark of conformity

Footswitch Symbols

Activate vibration

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 1-11
Classification and Console Symbols

Symbol Description

Activate fast flush (irrigation)

NOT FOR Accessories marked with the ‘NOT FOR HUMAN USE’ label are
HUMAN supplied for demonstration purposes only.
USE

Do not push, lean or rest against the control panel, or against the
front or sides of the console. When moving the console, push the
console using the handle only.

1-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 2
Introduction to the System
2

In this section:

• For Your Information, page 2-1

• About the CUSA® Excel/CUSA® Excel+ System, page 2-2
• About the Handpieces, page 2-4
• About the Tissue Select® Feature, page 2-6
• Sterilization of Handpieces and Accessories, page 2-9

For Your Information

Caution
Read the instructions, warnings, cautions, and notices provided with the CUSA®
Excel/CUSA® Excel+ System before use. Otherwise, injury to the patient or user
or equipment damage may result.

This section presents general information about the

CUSA Excel/CUSA Excel+ Ultrasonic Surgical Aspirator System: what it
is, what it does, and how it works. It also describes the handpiece
functions, configurations, and the sterilization requirements for the
handpiece and accessories.
For complete instructions on handpieces and accessories, see Section 7
to Section 11.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-1
About the CUSA® Excel/CUSA® Excel+ System

About the CUSA® Excel/CUSA® Excel+ System

The CUSA Excel/CUSA Excel+ System is an ultrasonic surgical aspirator
that allows a surgeon to remove tissue – selectively and with greater
control. It performs three functions:
• Fragmentation
• Irrigation
• Aspiration (Suction)
All three functions may occur at the same time.
The system includes the following components:
• Console:
 The Console Body houses electronics, pumps, and mechanical
parts.
 The Control Panel allows the user to control the functions of the
system.
• Handpiece: a handheld surgical device with a tip that is applied to
patient tissue.
• Accessories: manifold tubing, tips, tip torquing bases, torque
wrenches, sterilizer cases and contamination guard.
You can also combine the CUSA Excel System with electrosurgery using
the optional CUSA Electrosurgical Module (CEMTM). Refer to the
Instructions for Use for the CEM for details.
When you receive the CUSA Excel System, the shipment contains
accessories that are marked with the label ‘NOT FOR HUMAN USE’.
Accessories marked with the ‘NOT FOR HUMAN USE’ label are supplied
for demonstration purposes only.

Fragmentation

Electromechanical Operation
The console provides alternating current at 23 or 36 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 (refer to the figure at left). The transducer vibrates at 23 or 36 kHz.
The transducer transmits vibrations through a metal connecting body to an
attached surgical tip. The frequency of vibration remains the same at the
tip (23 or 36 kHz), but the amount of motion (amplitude) at the tip varies:
lower frequency, greater amplitude; higher frequency, smaller amplitude.
Amplitude also varies with the transducer/connecting body/tip
configuration: handpiece angles reduce tip amplitude.
When the vibrating tip contacts tissue, it breaks cells apart (fragments
them).

2-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the CUSA® Excel/CUSA® Excel+ System

Cooling
The high frequency vibration generates heat. To reduce the heat, the
system includes a closed, recirculating cooling water system. This system
pumps 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 ml/min.
As it passes through the handpiece, the water removes heat. Normal
handpiece temperature, in sustained heavy use, remains at less than
40°C/104°F.
Use distilled water for the cooling water system. Do not use tap water
because it contains impurities (natural minerals, chemical additives, or
organic materials) that can cause problems within the cooling water
system.

Irrigation
Sterile irrigation fluid flows from an IV set (bottle or bag and IV
administration tubing) to a variable speed peristaltic pump. The pump:
• Moves fluid at 1 to 10 ml/min; default flow is 3 ml/min. Use the
adjustment buttons (blue up/down arrows on black buttons at the
bottom of the irrigation display column on the control panel) to increase
or decrease the irrigation flow.
• Accelerates to a Fast Flush speed, pumping at greater than 25 ml/min.
The Fast Flush pedal on the system footswitch activates the Fast Flush
feature.
The accuracy of the irrigation flow is +/- 20% of setting or +/-1 ml/min,
whichever is greater.
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
in the sterile field and continually clearing the suction system. Fluid that
does not pass through the pre-aspiration holes irrigates the surgical site
and suspends fragmented tissue.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-3
About the Handpieces

Aspiration (Suction)
A vacuum pump in the console body provides up to 26 inHg/660 mmHg
maximum vacuum at sea level. Use the adjustment buttons (green
up/down arrows on black buttons at the bottom of the aspiration display
column on the control panel) to increase or decrease the suction from 10
to 100% in 10% increments.

Pre-aspiration Hole (x2)

Threads

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.
The accuracy of the vacuum level between contamination guard and
vacuum pump inlet is ± 15% of scale setting or ± 2.6 inHg/ 66 mmHg,
whichever is greater.
A suction pinch valve on the front of the console opens when the system is
on, and closes to stop suction when:
• Priming the irrigation system
• Pressing the Fast Flush pedal
• Releasing the Vibration pedal in Run Status (in this case, the pinch
valve closes for approximately one second, then re-opens).
• Releasing the Vibration pedal in Lap Mode (this suction stoppage
prevents depletion of the pneumoperitoneum).
When the System Power Switch is off, the suction pump remains off and
the suction pinch valve remains closed. Use the button on the front of the
suction pinch valve to open the valve manually.

About the Handpieces

Warning
Only use Integra® handpieces and accessories with the CUSA
Excel/CUSA Excel+ System. Non-Integra handpieces and accessories are not
supported.

2-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Handpieces

A CUSA Excel/CUSA Excel+ handpiece is a handheld surgical device. It

houses a transducer that vibrates at an ultrasonic frequency, transferring
the vibrations to a hollow titanium tip. The figure (on left) shows the
direction of vibration.
When applied to patient tissue, the vibrating tip provides the desired
surgical effect – the fragmentation and removal of specific tissue.
The handpiece connects to the console by a handpiece cable and by
manifold tubing:
• The cable consists of electric wires that power the transducer, and two
water tubes. The circulating water removes heat from the vibrating
transducer.
• The disposable manifold tubing consists of a tube for sterile irrigation
fluid, which the console pumps to the handpiece, and a tube for
suction. Clips on the manifold tubing fasten the tubing to the handpiece
cable.

Handpiece Functions
Together, a handpiece and CUSA Excel/CUSA Excel+ console form an
ultrasonic surgical aspirator system. This system has three functions:
• Fragmentation: As the vibrating tip contacts tissue, the vibrations break
the tissue cells into fragments.
• Irrigation: Sterile irrigation fluid, pumped from the console through the
manifold tubing, suspends the fragmented cells so that suction can
easily remove them and prevent tip blocking. The irrigation fluid also
cools the vibrating tip.
• Aspiration (Suction): Suction through the hollow tip removes the
fragmented tissue and irrigation fluid from the surgical site.
All three functions can occur at the same time.

Handpiece Configurations

The CUSA Excel/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).

Notice
The 36kHz handpiece operates within a frequency range and 36kHz is a
representative value. Refer to the Technical Specification section for the
frequency range.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-5
About the Tissue Select® Feature

Handpiece Tips
A variety of handpiece tips are available.Tips vary in inside diameter,
length, and shape (straight or curved). For information on the tips
available for each handpiece, contact your Integra representative.

About the Tissue Select® Feature

The Tissue Select® feature allows the surgeon to maintain a high
fragmentation rate while increasing selectivity and control at the surgical
site.
Fragmentation occurs when the vibrating tip interacts with tissue. As the
tip begins to move toward tissue, it accelerates, then impacts and
penetrates the tissue. The acceleration, impact, and penetration produce
a combination of direct mechanical forces and hydrodynamic pressures
that burst cells.
Several variables affect the fragmentation rate. Most are functions of the
CUSA Excel/CUSA Excel+ System:
• Stroke (tip excursion—the total distance the tip travels) – greater
stroke results in greater fragmentation rate
• Suction
 Suction has two functions:
(1) It draws tissue toward the vibrating tip and creates a tip/tissue
coupling effect.
(2) It removes irrigation and fragmentation debris from the surgical
site.
 If there is no suction or low suction, coupling does not occur,
resulting in minimal tissue fragmentation and increased tissue
temperature.
• Tip acceleration – produces the peak forces and pressures that
fragment tissue.
• Tip cross-sectional area at the tip-tissue contact site
These variables also affect tactile feedback—what the surgeon’s hand
feels when using the handpiece.

Inherent Tissue Selectivity

With all other variables remaining constant, the tip does not fragment all
tissue types equally effectively. Another variable – tissue strength – affects
fragmentation rate.
• “Low strength” soft tissues that are easiest to fragment include the
brain and most organs. Older, partially dried tissues are also easy to
fragment “High strength” strong tissues that are most difficult to
fragment include vessel structures, tendons, ligaments, healthy skin,
and organ capsules.

2-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Tissue Select® Feature

• Strength increases and fragmentation rate decreases with tissue

containing greater collagen, elastin, or both (collagen type, quantity,
and organization affect cell structural quality).
Tissue strength also affects tactile feedback. The surgeon can feel a
difference between the tip contacting low strength tissue and the tip
contacting high strength tissue. As the tip works through low strength
tissue, the surgeon feels a smooth, rhythmic sensation from the
handpiece. When the tip contacts high strength 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.

In Standard Mode, continued manual pressure could result in unintentional

damage to critical structures. Using the Tissue Select feature, the CUSA
Excel/CUSA Excel+ System can help the surgeon avoid these problems
when dissecting near critical structures.

Increasing Tissue Selectivity

It is possible to increase the inherent selectivity resulting from variations in
tissue strength while maintaining stroke amplitude, tip acceleration, and
suction. This increase in selectivity results from reducing the reserve
power that drives the tip. Remember: The ultrasonic generator delivers
electrical power (which is directly related to the acoustic power present at
the tip, which results in fragmentation) to the handpiece. Consider 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.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-7
About the Tissue Select® Feature

A Common Misunderstanding of the Amplitude Setting

It has been common practice to decrease the amplitude setting when
encountering critical structures. The reasoning behind this practice is that
the lower amplitude setting results in slower fragmentation rate and
greater selectivity, thus greater control to help avoid damage when
dissecting near the critical structures. Consider this reasoning more
carefully:
True: Decreasing the amplitude setting also decreases the fragmentation
rate.
True: Because the fragmentation rate is slower, the surgeon has a little
more time to move the tip away from a critical structure before damaging
it; therefore, the surgeon seems to have greater selectivity and control.
False: The surgeon gains greater selectivity, thus greater control and
precision, when dissecting near critical structures.
Why does the decrease in amplitude not give greater selectivity and
control? Decreasing the amplitude does not greatly affect the reserve
power.

Decreasing the amplitude leaves plenty of reserve power.

When the tip contacts critical structures, it still has more than enough
power to fragment them if the surgeon applies pressure or prolongs the
tip-tissue contact. Therefore, decreasing the amplitude setting gives the
following results:
• Reduced fragmentation ability
• Reduced fragmentation rate
• Little increase in selectivity
• Little reduction in reserve power

Benefits of the Tissue Select Feature

The Tissue Select feature presents several benefits:
• Maintains fragmentation ability
• Reduces (automatically) fragmentation rate

2-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Sterilization of Handpieces and Accessories

• Provides maximum tissue selectivity

• Gives surgeon superior tactile feedback
• Gives surgeon greater control and precision when dissecting near
delicate structures

For information on using the Tissue Select feature, see Using the Tissue
Select Feature, page 6-4.

Sterilization of Handpieces and Accessories

You must sterilize the CUSA Excel/CUSA Excel+ handpiece with steam
before use. Some of the CUSA Excel/CUSA Excel+ System accessories
are sterile, single-use items. Other accessories are reusable. You must
sterilize all reusable accessories with steam before use.
Notice
Before sterilization, refer to handpiece cleaning and reprocessing information,
see Cleaning the Handpiece, page 13-4.

Table 2-1 describes the sterilization requirements for the handpiece and
accessories. For information on the sterilization parameters and
sterilization procedure for the handpieces and accessories, see
Sterilization Parameters, page 9-1.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-9
Sterilization of Handpieces and Accessories

Table 2-1 Handpiece and

Accessory Sterilization
Item Supplied Reusable Permitted Sterilization
Sterile /Requires Number of Method
Sterilization by Sterilizations
the User

Handpieces No Yes Varies per Steam

handpiece
and
sterilization
cycle.
See Cleaning
the Handpiece,
page 13-4 and
Permitted
Number of
Reprocessing
Cycles for
Handpieces
when Cleaned
with an
Automatic
Washer, page
13-6
Note: See
“Recalibrate the
Handpiece” on
page 15-3.

Standard No Yes Unlimited Steam

nosecone

Extended Life No Yes Six Steam

Tip (ELT)
No Yes One
ELT Flue

2-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Sterilization of Handpieces and Accessories

Item Supplied Reusable Permitted Sterilization

Sterile /Requires Number of Method
Sterilization by Sterilizations
the User

Standard Tip Yes No - Single patient One* Not

and Flue use only applicable
*Note: The
sterile tips are
for single
MicroTip™ and Yes No - Single patient Not
patient use
Flue use only applicable
only. Each tip
can be
resterilized
Extended Yes No - Single patient Not
once before
Length use only Applicable
use but the tip
MicroTip™ Plus
cannot be
reused or
reprocessed.
MacroTip™ Yes No - Single patient Not
and Flue use only applicable

SaberTip™ and Yes No - Single patient Not

Flue use only applicable

ShearTip™ and Yes No - Single patient Not

Flue use only applicable

Manifold Yes No - Single patient One* Steam

Tubing use only
*Note: The
manifold
tubing is for
single patient
use only. It
can be
resterilized
once before
use but it
cannot be
reused or
reprocessed.

Sterile Torque Yes No - Single patient None Not

Wrench use only applicable

Sterilizable No Yes Unlimited Steam

Torque Base

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 2-11
Sterilization of Handpieces and Accessories

Item Supplied Reusable Permitted Sterilization

Sterile /Requires Number of Method
Sterilization by Sterilizations
the User

Tip Torquing No Reusable only. None Not

Set The tip torquing applicable
set only used
outside of the
sterile field.

Warning
Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed
or re-used this may result in the infection of patient (or patient specimen)
through cross-contamination, as well as would incur the risk of modifying the
properties and performance of the device, and of increasing the likelihood of
complications and/or undesirable effects. Once used, devices must be disposed
of in accordance with hospital policies.

2-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 3
Console Components
3

In this section:

• For Your Information, page 3-1

• About the Console and Structural Features, page 3-2
• Console Body – Front Panel, page 3-4
• Console Body – Side Panel, page 3-7
• Console Body – Rear Panel, page 3-9
• About the Power Switches, page 3-13

For Your Information

This section presents the console for the CUSA® Excel/CUSA® Excel+
Ultrasonic Surgical Aspirator System. It provides an overview of the
console, and a description of each major console subsystem and its
components.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-1
About the Console and Structural Features

About the Console and Structural Features

Figure 3-1 presents the front view of the console; the components are
described in Table 3-1.
Figure 3-1 Console – Front View

Control Panel

IV pole
®

Arm

Housing for
Irrigation Pump
Head and Suction
Pinch Valve

Arm Housing

Console Body

Cooling Water
Reservoir

Shelf for Suction

Canister

Casters

Table 3-1 Description of Console Structural Features

Component Description

IV Pole Supports the sterile irrigation fluid container. You can raise or
lower the pole, and rotate it 90° in the lower position. The
safe working load for the I.V. pole is 2 kilograms.

Control Panel Allows the user to control all system functions. See Section
4: Control Panel Display and Functions.

3-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Console and Structural Features

Table 3-1 Description of Console Structural Features

Component Description

Arm • Supports the control panel

• Pivots the control panel 135°, providing users with a view
of the control panel from most of the operating room
• Raises to two adjustable heights for ergonomic use

Arm Housing Covers the arm attachment along the console body side
panel.

Housing for Prominent black area at the top of the console body:
Irrigation Pump
• The irrigation pump head and irrigation tube pathway
Head and
(marked with blue lines)
Suction Pinch
Valve • The suction pinch valve and suction tube pathway (marked
with a light green line)

Console Body Contains the electronics, pumps, and other working

components.

Shelf for Provides a place to put the hospital-provided suction

Suction canister.
Canister

Casters Unlocked, both front and rear casters roll easily and rotate
freely. When locked, each caster has a brake lock that stops
the wheels from rolling.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-3
Console Body – Front Panel

Console Body – Front Panel

Figure 3-2 shows the front view of the console; the components are
described in Table 3-2.
Figure 3-2 Console Body – Front
Panel

Handpiece
Connector
Receptacle ®

Irrigation Pump
Head

Suction Pinch
Valve

System Power
Switch

Contamination Guard

Retaining Bail for

Suction Canister

3-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Console Body – Front Panel

Table 3-2 Description of Console Body Components - Front Panel

Component Description

Handpiece Connects the handpiece to the console. It is on the left side

Connector of the console (as you face the front panel).
Receptacle

Warning
When you connect the handpiece to the console, the
handpiece becomes a functional surgical device.

Suction Pinch Closed, the valve pinches off suction flow to the handpiece
Valve when:
• Priming the handpiece with irrigation fluid
• Pressing the Fast Flush pedal
• Releasing the Vibration pedal (in LAP Mode)
When the System Power Switch is off, the suction pump
remains off and the suction pinch valve remains closed.
Use the button on the front of the suction pinch valve to
open the valve.

Warning
To avoid injury to surgical personnel, keep fingers
away from the suction pinch valve.

System Power On ( | ): activates all system components and begins filling

Switch the handpiece with cooling water.
Off ( ) : activates the cooling water drain cycle. When
the system has drained water from the cooling water
system (about one minute), it automatically deactivates all
system components.

Irrigation Pump Rotate the latch from right to left to open the pump head,
Head and from left to right to close. When open, insert irrigation
tubing into the peristaltic pump. When closed, the pump
head holds irrigation tubing against the peristaltic pump.

Contamination Protects the vacuum pump from particulate matter and

Guard moisture in the suction stream. It is necessary to replace
the contamination guard every six months or when the
color changes.
Important
The guard is hydro-philic and
becomes blocked when wet.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-5
Console Body – Front Panel

Table 3-2 Description of Console Body Components - Front Panel

Component Description

Retaining Bail for Holds the suction canister in place on the shelf.
Suction Canister

3-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Console Body – Side Panel

Console Body – Side Panel

Figure 3-3 shows the side view of the console; the components are
described in Table 3-3.
Figure 3-3 Console Body – Side
Panel

IV Pole

Control Panel

Rotation Lock Arm

Handle
IV Pole Release
Housing (Black) for Button
Irrigation Pump Head
and Suction Pinch Valve
Arm Housing

Arm Release Tab

Cooling Water
Reservoir Release
Button

Cooling Water
Reservoir

Table 3-3 Description of Console Body Components – Side Panel

Component Description

Control Panel See Section 4: Control Panel Display and Functions.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-7
Console Body – Side Panel

Table 3-3 Description of Console Body Components – Side Panel

Component Description

Rotation Lock Releases the control panel, allowing it to swivel and lock
Handle into one of four positions:
• Straight forward
• 45° right
• 45° left
• 90° left

Housing for See Table 3-1.

Irrigation Pump
Head and Suction
Pinch Valve

IV Pole

Arm and Arm

Housing

IV Pole Release Releases the IV pole, to raise or lower it.

Button

Arm Release Tab Releases a lock that holds the arm in the vertical position.

Cooling Water Holds cooling water to be continuously circulated through

Reservoir the handpiece. The reservoir holds 1000 ml sterile or
distilled water. A clear panel, which runs vertically up the
side, shows the water level inside the reservoir.
The reservoir also includes fittings that snap into
receptacles inside the Arm Housing on the console side
panel. The fittings and receptacles connect the reservoir
to the cooling water system.

3-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Console Body – Rear Panel

Console Body – Rear Panel

Figure 3-4 and Figure 3-5 show the rear view of the console; the
components are described in Table 3-4.
Figure 3-4 Console Body – Rear
Panel

Speaker

Volume Control

Footswitch
Connector

AC Main Switch

Fuses (x2)

Footswitch

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-9
Console Body – Rear Panel

Figure 3-5 Console Body – Rear

Panel Continued

Storage Compartment

Cord Wrap

Serial Number Label and Equipotential AC Power Cord

Regulatory Approval Labels Grounding Lug

3-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Console Body – Rear Panel

Table 3-4 Description of Console Body Components – Rear Panel

Component Description

Speaker Sounds an audible tone four times when an alarm condition

exists, and sounds a constant tone when vibration is active.

Volume Control Adjusts the active vibration audible tone. You cannot adjust
the alarm tone.

VOLUME

Footswitch Connects the footswitch to the console.

Connector
Receptacle

AC Main Switch Controls AC power input to the system. See Section 3: About
the Power Switches.

Fuses Protect the system from electrical overloads.

Footswitch Use the pedals on the footswitch 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 greater than 25 ml/min. It also closes the
Suction Pinch Valve, stopping suction. When you release
the pedal, irrigation returns to the setpoint value and
suction resumes.

AC Power Cord Connects the system to the Mains power supply.

Equipotential Allows for the connection of a Potential Equalization

Grounding Lug Conductor that provides a connection between the
equipment and the potential equalization busbar of the
electrical installation (in accordance with the requirements of
IEC 60601-1). This is a biomedical function.

Labels Displays the console model number, serial number and

regulatory approvals.

Cord Wrap Use the four cord wraps to hang the cord on the back of the
unit, keeping the cord safely out of the way.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-11
Console Body – Rear Panel

Table 3-4 Description of Console Body Components – Rear Panel

Component Description

Storage Stores the footswitch and manual (includes one interior shelf)
Compartment

3-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Power Switches

About the Power Switches

The CUSA Excel/CUSA Excel+ console includes two power switches:
AC Main Switch

AC Main Switch
Located on the rear panel, this switch controls AC power input to the
system. It does not activate the system; instead, it provides AC power to
the System Power Switch (on the front panel) so that you can activate the
system with the System Power Switch.
Once the AC Main Switch is on ( | ), you may leave it on, even when you
unplug the console from the wall receptacle.
Note: To isolate the CUSA Excel/CUSA Excel+ from the AC power supply,
you must unplug the console from the power source.

System Power Switch

®

Located on the front panel, this black switch activates system

components, turning the CUSA Excel/CUSA Excel+ console on ( | ) or
off/standby ( ).

Warning
System
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE
Power
CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

Warning
The power cord on this product contains lead, a chemical known to the State of
California, USA, to cause cancer, and birth defects or other reproductive harm.
Wash hands after handling. The power cord complies with the DIRECTIVE
2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of
8 June 2011 on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (recast).

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 3-13
Notes

3-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 4
Control Panel Display and
4

Functions

In this section:

• For Your Information, page 4-1

• About the Control Panel Display, page 4-2
• Signs and Symbols on the Excel8 and Excel9 Control Panel,
page 4-10
• Signs and Symbols on the Excel and Excel 2 Control Panel,
page 4-12
• Understanding the Control Panel at System Startup, page 4-13

For Your Information

This section presents the control panel for the CUSA® Excel/CUSA®
Excel+ Ultrasonic Surgical Aspirator System.
The control panel can contain icons only, or icons and text, depending on
the product model. The control panel for the Excel8 and Excel9 product
models contains icons only. The control panel for the Excel product model
contains icons and text. This chapter describes the control panel display
for the different models. It also describes the control panel behavior during
system startup and operation.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-1
About the Control Panel Display

About the Control Panel Display

The control panel display for the Excel8 and Excel9 models (Figure 4-1),
and the Excel model (Figure 4-2), are illustrated in this section. Note: The
control panel display is also printed on the quick reference cards (to be
fitted in a slot at the rear of the control panel).
Figure 4-1 Control Panel for
Excel8 and Excel9 models

Lap Mode button (light green)

Lap On indicator (green)

General Alarm Symbol Test button (orange)

(cyan) Prime button (blue) Status button (green)

Alarm indicators (cyan):

Vibration
Footswitch Setpoint indicators (green)
Handpiece
Cooling Water

4-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Control Panel Display

Figure 4-2 Control Panel for

Excel and Excel 2 model

Lap Mode button (light green)

Lap On indicator (green)

General Alarm Symbol
(cyan)
Prime button (blue) Test button (orange) Status button (green)

Alarm indicators (cyan):

Vibration
Footswitch
Handpiece Setpoint indicators (green)
Cooling Water

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-3
About the Control Panel Display

Alarm Indicators
The CUSA Excel/CUSA Excel+ activates an alarm to indicate a technical
problem with the system. All alarms on the CUSA Excel/CUSA Excel+ are
technical, low-priority alarms, for example, mechanical or equipment-
related. There are no physiological alarms on the CUSA Excel System.
When the CUSA Excel/CUSA Excel+ System activates an alarm, it:
• Illuminates the general alarm symbol in cyan on the control panel. This
indicates that an alarm exists on the system
• Illuminates one or more alarm indicators in cyan on the control panel.
This indicates the type of alarm(s) that exist
• Sounds the alarm tone four times
Table 4-1 describes each of the alarms on the CUSA Excel/CUSA Excel+
System. The general alarm symbol and alarm indicator(s) remain
illuminated until you resolve the corresponding problem(s). For
information on troubleshooting alarms, see Troubleshooting the System,
page 14-1.

Table 4-1 Description of Alarms

Alarm Alarm Alarm Cause Alarm Alarm

Indicator Classification Priority

General Triggered when Technical Low

an alarm condition
exists

Handpiece Triggered when Technical Low

system detects
that there is no
Handpiece
connected.

Footswitch Triggered when Technical Low

system detects
that there is no
Footswitch
connected.

Vibration Triggered when Technical Low

excessive
vibration at tip is
detected.

Cooling Triggered when Technical Low

Water issue with the
cooling system is
detected.

4-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Control Panel Display

See Figure 4-1 and Figure 4-2 for the location of the alarm indicators on
the control panel.
There is no method to silence alarms from the control panel, therefore, to
manually turn off an alarm, you must turn off the console. If the system
shuts down unexpectedly (for example a power failure) with an alarm
illuminated on the control panel, the alarm remains illuminated when you
power the system on again.The only method of turning off the alarm
indicator on the control panel is to resolve the corresponding alarm.
Recommended: When you set up the CUSA Excel/CUSA Excel+ for
surgery, make sure that the control panel is always clearly visible to the
surgeon in the event of an alarm. Remove any obstructions that may block
the surgeon’s view of the control panel.

Lap Mode, Prime, Test, and Status Buttons

To activate Lap Mode, Prime, or Status, press the button once; to
deactivate the function, press the button again. To activate Test, press the
button once; it automatically deactivates when the test is complete.
Lap Mode: Selects the Laparoscopic mode of operation – the system
provides no suction or irrigation to the handpiece until you activate the
Vibration pedal.
When you activate the Lap Mode, the system illuminates the Lap Mode
indicator.
Prime: Automatically increases irrigation rate to 25 to 30 ml/min to pump
irrigation fluid to the tip. A timer turns Prime off after approximately one
minute.
Test: Verifies the handpiece is working properly by automatically
increasing tip amplitude to 100%, then decreasing it to 0% – all within
4 seconds.
Status: Toggles the status between Standby and Run.

See Figure 4-1 and Figure 4-2 for the location of the Lap Mode, Prime,
Test, and Status buttons on the control panel.

Setpoint Indicators
Green setpoint indicators show user adjusted setpoints for Aspiration,
Irrigation, and Amplitude:
• Not Activated: One setpoint indicator illuminates to show the setpoint
value
• Activated: All setpoint indicators up to and including the setpoint value
light up.
For Tissue Select®, “Std” (standard) is the first setpoint value; “++++” is the
highest setpoint value and indicates increased selectivity.
See Figure 4-1 and Figure 4-2 for the location of the setpoint indicators on
the control panel.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-5
About the Control Panel Display

Figure 4-3 Control Panel –

Excel8 and Excel9 model (status
indicators and setpoint
adjustment)

Status Indicators:
Run (Green)
Standby (Orange)
Wait/Cooling Water (Orange)

Setpoint Adjustment buttons

(Up/Down Arrows):
Aspiration (Green)
Irrigation (Blue)
Amplitude (Orange)
Tissue Select® (Yellow)

4-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Control Panel Display

Figure 4-4 Control Panel – Excel

and Excel 2 model (status
indicators and setpoint
adjustment)

Status Indicators:
Run (Green)
Standby (Orange)
Wait/Cooling Water
(Orange)

Setpoint Adjustment buttons

(Up/Down Arrows):
Aspiration (Green)
Irrigation (Blue)
Amplitude (Orange)
Tissue Select® (Yellow)

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-7
About the Control Panel Display

Status Indicators
To change from Standby to Run, or from Run to Standby, press the Status
button.
Run: A green status indicator illuminates to show when the system is in
Run status. The CUSA Excel/CUSA Excel+ must remain in Run mode for
a minimum of two minutes (continuous) before it is ready for use; once the
two minutes elapses, the system is ready for use.
Standby: An orange status indicator illuminates when the system is in
Standby.
Wait/Cooling Water: The Wait status indicator flashes and the Cooling
Water status indicator illuminates in the following circumstances:
• Immediately after turning on ( | ) the System Power Switch, the system
automatically fills the handpiece with cooling water.
• Immediately after turning off ( ) the System Power Switch, the
system automatically drains handpiece cooling water.
While the Wait/Cooling Water status indicators remain lit, you cannot use the
control panel or footswitch.
See Figure 4-3 and Figure 4-4 for the location of the status indicators on
the control panel.

Setpoint Adjustment Buttons

Marked with Up/Down arrows, use these buttons to adjust the setpoint
values:
• Aspiration (Suction): 10 increments; linear scale of 10 to 100%;
default value is 100%.
• Irrigation: 10 increments; linear scale of 1 to 10 ml/min; default value
is 3ml/min.
• Amplitude: 10 increments; linear scale of 10 to 100%; default value is
10%.
• Tissue Select: 5 increments from Std (standard operation) to ++++.
Tissue Select interrupts continuous vibration for specified times:

Setting On-Time Off-Time

Std continuous 0 ms*

+ 40 ms 10 ms

++ 30 ms 10 ms

+++ 20 ms 10 ms

++++ 10 ms 10 ms

*1 ms = 1 millisecond = 1 one-thousandth of a second

4-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 About the Control Panel Display

Push a button once for a single change in setpoint value. Note: Holding
down the button will only produce a single change in setpoint value.
See Figure 4-3 and Figure 4-4 for the location of the setpoint adjustment
buttons on the control panel.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-9
Signs and Symbols on the Excel8 and Excel9 Control Panel

Signs and Symbols on the Excel8 and Excel9 Control Panel

Table 4-2 lists each symbol and its meaning. You can find this symbol list
on the quick reference guide (to be fitted at the top of the control panel).

Table 4-2 Signs and Symbols on the Excel8 and Excel9 Control Panel

Symbol Description

General alarm symbol: Indicates that an alarm condition

exists (cyan, left side of panel).

Vibration alarm: Vibration failure/The handpiece is not

working properly (cyan, left side of panel).

Test (orange, top of amplitude display): System in Test mode.

Footswitch alarm: Footswitch failure or footswitch connector

not plugged into its receptacle on the console rear panel
(cyan, left side of panel).

Handpiece alarm: Handpiece failure or handpiece connector

not plugged into its receptacle on the console (cyan, left side
of panel).

Cooling Water alarm: Cooling water problem in the system

(cyan, left side of the control panel).

Wait (orange, right side of the control panel): System is

circulating cooling water through the handpiece or draining
the handpiece

4-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Signs and Symbols on the Excel8 and Excel9 Control Panel

Table 4-2 Signs and Symbols on the Excel8 and Excel9 Control Panel

Symbol Description

Suction adjust

Irrigation adjust

Amplitude adjust

Std Standard

Standby

Run

Start action/change status

Prime

Lap Laparoscopic Mode is On/Selected (green, top left of control

panel)

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-11
Signs and Symbols on the Excel and Excel 2 Control Panel

Signs and Symbols on the Excel and Excel 2 Control Panel

Table 4-3 lists each symbol and its meaning. You can find this symbol list
on the quick reference guide (to be fitted at the top of the control panel).

Table 4-3 Signs and Symbols on the Excel and Excel 2 Control Panel

Symbol Description

General alarm symbol: Indicates that an alarm condition

exists (cyan, left side of panel).

Vibration alarm: Vibration failure/The handpiece is not

working properly (cyan, left side of panel).

Footswitch alarm: Footswitch failure or footswitch connector

not plugged into its receptacle on the console rear panel
(cyan, left side of panel).

Handpiece alarm: Handpiece failure or handpiece connector

not plugged into its receptacle on the console (cyan, left side
of panel).

Cooling Water alarm: Cooling water problem in the system

(cyan, left side of the control panel).

Lap On Laparoscopic Mode is On/Selected (green, top left of control

panel)

4-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Understanding the Control Panel at System Startup

Understanding the Control Panel at System Startup

When you turn on ( | ) the System Power Switch, it activates the
CUSA Excel/CUSA Excel+ System components. This section presents the
control panel features in the order in which you will encounter them as you
set up, test, and use the system.
Note: The Excel8 and Excel9 control panel illustration is shown for
reference only.

When you turn on ( | ) the System Power Switch (on the front panel), the
CUSA Excel/CUSA Excel+ System illuminates all indicators on the control
panel, including the alarm indicators, for approximately four seconds; then
it turns off all indicators.
The CUSA Excel/CUSA Excel+ System then checks for the footswitch and
the handpiece connections. If the system detects the footswitch and
handpiece, the Wait (flashing) and the Cooling Water (solid) status
indicators turn on. After one minute, the Wait and Cooling Water status
indicators turn off. The Test and Prime indicators then turn on. If the
system cannot detect either the handpiece or footswitch connections, it
activates the appropriate alarm.

Footswitch Alarm
When turned on ( | ), if the system does not find the footswitch connection,
it illuminates the general alarm symbol and the Footswitch alarm indicator,
and it sounds the alarm tone four times. Then it turns off the Wait status
indicator. If this occurs, make sure the footswitch is connected to the
console rear panel. If not, connect it. The Footswitch alarm will turn off and
the Wait status indicator will turn on.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-13
Understanding the Control Panel at System Startup

Handpiece Alarm
When turned on ( | ), if the system does not find the handpiece connection,
it illuminates the general alarm symbol and the Handpiece alarm indicator,
and it sounds the alarm tone four times. Then it turns off the Wait status
indicator. If this occurs, make sure the handpiece is connected to the
console. If not, connect it. The Handpiece alarm will turn off and the Wait
status indicator will turn on.
Note: When turned off ( ), the system automatically drains the cooling
water from the handpiece and the cooling water system; the Wait status
indicator and Cooling Water status indicator illuminate. Do not disconnect
the handpiece while the system is draining cooling water. If you do, the
system illuminates the Handpiece alarm and turns off the Wait status
indicator. If this happens, reconnect the handpiece to the console. The
system turns the Wait status indicator on and the alarm off, and resumes
draining the cooling water. When the system completes draining the
cooling water, the entire control panel turns off (goes blank). Then you can
disconnect the handpiece.
System startup will not proceed until you clear a handpiece or footswitch
alarm. If you connect the handpiece and footswitch and the corresponding
alarm indicator remains on, call Integra for assistance.

Wait Wait/Cooling Water

When the system detects that the handpiece and footswitch are
connected, it automatically begins to circulate cooling water through the
handpiece. This takes about one minute to complete. While the system
performs this task, the orange Wait status indicator flashes and the orange
Cooling Water status indicator (upper right on the control panel)
illuminates.
When the Wait and Cooling Water status indicators are illuminated, you
cannot use the control panel. When the system turns off the Wait and
Cooling Water status indicators, it turns on the suction pump, the Test
status indicator, and the Prime status indicator.

Cooling Water Alarm

If the system detects a cooling water problem, it illuminates the general
alarm, symbol and the Cooling Water alarm indicator (left side of the
control panel), and it sounds the alarm tone four times. Possible causes
for this alarm are:
• No water in the cooling water reservoir
• Disconnected cooling water reservoir
• Damaged, misaligned, or missing o-rings in the handpiece connector
• Pinched or kinked handpiece cable
• Air leak in the cooling water system
To correct these conditions:
• Add water

4-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Understanding the Control Panel at System Startup

• Connect the reservoir

• Remove the pinch or kink
• For an air leak in the handpiece tubing, or an o-ring problem in the
handpiece connector, connect a new handpiece
While the Cooling Water alarm indicator remains illuminated, you cannot
use the control panel or footswitch.

Warning
Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to
use the system may result in injury to the patient and/or surgical personnel, or
equipment damage.

Test Test
Use the Test button (orange box on a black button) at the top of the
Amplitude display to test the handpiece function.
To test the handpiece, press the Test button. The system automatically
activates the handpiece at 100% vibration for 4 seconds. During the test,
green setpoint indicators in the amplitude display light up to 100% to show
that the handpiece is working correctly.
If the setpoint indicators do not light up to 100%, a problem may exist. To
troubleshoot:
• Push the Test button again
• Verify proper tip torquing
• If the problem persists, perform more complete troubleshooting (see
Section 14: Troubleshooting the System)

Vibration Alarm
If the handpiece is not working properly, the system illuminates the general
alarm symbol and the Vibration alarm (left side of the control panel), and it
sounds the alarm tone four times. Possible causes for this alarm are:
• Damaged tip
• Loose tip (not properly attached to handpiece)

Prime Prime
To start Prime, press the Prime button (blue box on a black button at the
top of the Irrigation display). You need to repeat Prime until you see
irrigation fluid flow at the handpiece tip. If it doesn’t, verify that all
connections are tight, then press the Prime button again.
The Prime button automatically increases the rate of the irrigation pump to
25 to 30 milliliters per minute (ml/min). Prime allows the system to pump
irrigation fluid through the manifold tubing, through the flue, and onto the
tip as quickly as possible, reducing setup time. Watch for irrigation fluid

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 4-15
Understanding the Control Panel at System Startup

dripping from the handpiece tip. Priming takes about one minute. As the
system primes, one setpoint indicator in the Irrigation display illuminates
every 6 seconds to show its progress.
To stop Prime at any time, press the Prime button again.
You can repeat the Prime process at any time by pressing the Prime
button once to start Prime, and pressing it again to stop Prime.
After priming, the system automatically proceeds to Standby status.

Standby Standby Status

When the system enters the Standby status, it illuminates the orange
Standby status indicator (upper right on the panel). It automatically sets
the following default values:
Aspiration 100%
Irrigation 3 ml/min
Amplitude 10%
Tissue Select Std
Before using the CUSA Excel/CUSA Excel+ System at the surgical site,
adjust setpoint values, then select Laparoscopic mode (if desired) and
Run status.

4-16 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 5
Setting Up the System
5

In this section:

• For Your Information, page 5-1

• Quick Reference – Setup, page 5-2
• Handpiece Assembly Options, page 5-3
• Preparing the System for Startup, page 5-4
• Turning On the System, page 5-7
• Connecting the Suction Tubing, page 5-7
• Connecting the Irrigation Tubing, page 5-9
• Testing the Handpiece, page 5-11
• Testing the Alarm Tone, page 5-12
• When the Surgeon Is Ready, page 5-13

For Your Information

This section describes how to set up the CUSA® Excel/CUSA® Excel+
Ultrasonic Surgical Aspirator Systemfor surgery, starting with the arrival of
the sterilized handpiece and accessories to the operating room, and
ending with the system in Run mode ready for the surgeon’s use.
The CUSA Excel/CUSA Excel+ System requires a minimum of one hour
exposure at its operating temperature range before you use it. Make sure
that the system is located in the surgical room at least an hour before use.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-1
Quick Reference – Setup

Quick Reference – Setup

Use this list if you are a knowledgeable user who needs only a reminder of
the steps to set up the CUSA Excel/CUSA Excel+ System.

Handpiece Assembly
1. Attach the tip to the handpiece.

2. Assemble the o-rings to the tip.

3. Attach the standard nosecone onto the handpiece.

4. Attach the flue.

5. Attach the sterile manifold tubing (if not attached before sterilization).

6. Attach the aspiration and irrigation tubing at the handpiece.

Console Assembly
1. Plug the power cord into a wall receptacle.

2. Confirm that the AC Main Switch located on the rear panel is on.

3. Confirm that the footswitch is plugged into its receptacle.

4. Spike an irrigation bag (Lactate Ringer’s or normal saline) with large

drip IV administration set, and hang it at the side of the console.
5. Fill the cooling water reservoir with distilled water, then slide it into
place. Do not use tap water or saline solution.
6. Connect the suction canister to the console at the contamination
guard.
7. Connect a sterile handpiece to the system.

8. Turn on ( | ) the System Power Switch located on the front panel.

9. Connect the suction manifold tubing to the console and the suction
canister.
10. Connect the irrigation manifold tubing to the console and the IV
administration set. Open the IV clamp.
11. Wait until the Wait (flashing) and Cooling Water status indicators go off.

12. Press the Test button to check the setup of the handpiece. If the cyan
vibration alarm indicator does not illuminate, the handpiece is
functioning properly.
13. Press the Prime button to prime the handpiece with sterile irrigation
fluid.
14. Adjust settings for amplitude, suction, and irrigation.

15. Press the Status button to select the Run mode when the surgeon is
ready to use the system.The CUSA Excel/CUSA Excel+ System must
remain in Run mode for a minimum of two minutes (continuous) before
it is ready for use; once the two minutes elapses, the system is ready
for use.

5-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Handpiece Assembly Options

Handpiece Assembly Options

If you want to: Do this:

Assemble the tip to the Go to:

handpiece in a
nonsterile area before  Section 8, Assembling the Handpiece
sterilization in a Nonsterile Area
 Section 9, Sterilizing Handpieces and
Accessories
 Section 10, Completing Handpiece Setup
in the Sterile Field

Assemble the tip to the Go to:

handpiece in the sterile
field  Section 11, Assembling or Changing
Tips in the Sterile Field.

You also have the option of attaching manifold tubing to the handpiece
cable before or after handpiece sterilization. If you chose to attach the
manifold tubing after handpiece sterilization, you must attach it in the
sterile field, see Section 10: Completing Handpiece Setup in the Sterile
Field.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-3
Preparing the System for Startup

Preparing the System for Startup

At the Rear Panel

1. Plug the CUSA Excel/CUSA Excel+System power cord into a wall
receptacle.
2. Confirm that the AC Main Switch on the rear panel is on ( | ).

3. Verify that the system footswitch is connected to the rear of the

console.
4. Follow hospital policies and procedures regarding the placement of
footswitches into plastic bags.

On the Side Panel: Filling the Cooling Water

1. Remove the cooling water reservoir from the console:

a. Press the button (just above the reservoir) on the Arm Housing to
release the latch inside the housing.
b. Slide the reservoir toward the rear of the console, then remove it
from its slot.
2. Gently open the black rubber lid on the reservoir top.

3. Fill the cooling water reservoir to the line with 1000 ml distilled water
(sterile water is distilled).

Warning
Do not fill the Cooling Water reservoir with tap water or saline solution. Use
distilled water only.

4. Gently close the black rubber lid.

5. Slide the cooling water

reservoir into the slot on the
console side panel until it
snaps into place.

off.
Min.
on, 5
SN Min.
loading,10
intermittent
VA with
Hz 900
110-120/220-240V~ operation
50/60
Continuous
Date
Mfg.
BF
Type
USA
Classification: 80301-3299S.A.
CO Center,
Boulder, Services
Inc,
Valleylab European
France
Suture
Auto Elancourt,
78990in USA
Made

5-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Preparing the System for Startup

On the Front Panel: Suction

Notice
To prevent fluid flowing into the vacuum line, only use a suction canister that has
a non-return valve.

1. If used, install the

specimen trap into the
hospital-provided suction
canister.
2. Put the suction canister
on the shelf in the front of
the console.

3. Verify that the contamination guard is in place in the console.

Note: We recommend you retain a second contamination guard in the
surgical environment in case the guard becomes blocked.
4. Attach the green
L-shaped connector from
the contamination guard
to the VACUUM port on
the suction canister lid.

5. Secure the canister with the retaining bail.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-5
Preparing the System for Startup

On the Front Panel: Handpiece

1. Connect the handpiece to
the console.

Warning
When you connect the
handpiece to the console,
the handpiece becomes a
functional surgical device.

Caution
Sharp edge at the handpiece
connection point.

a. Line up the notch on

the handpiece
connector to the key
in the receptacle (at
the 12 o’clock
position).

b. Gently push the handpiece connector onto the console connector.

c. Turn the connecting

ring in the clockwise
direction until the
yellow dot on the
handpiece aligns with
the yellow dot on the
console.

5-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Turning On the System

Turning On the System

1. Turn on ( | ) the black System Power Switch (located on the front
panel) to activate the system.
2. Verify that all indicators on the control panel (including the alarm
indicators) illuminate for four seconds approximately, and then turn off
again.
Note: This step verifies that all indicators, including the alarm
indicators, are functioning correctly.
3. Verify that the Wait (flashing) and the Cooling Water status indicators
are on.
When active, the system draws distilled water through the handpiece
cooling system. This takes about one minute, during which time the
Wait (flashing) and Cooling Water status indicators illuminate. When
the system successfully fills the cooling system with water, it turns the
Wait and Cooling Water status indicators off.
4. While you wait for the Wait and Cooling Water status indicators to go
off, connect the manifold suction tubing to the console (next section).

Connecting the Suction Tubing

Warning
To avoid injury to surgical personnel, keep fingers away from the suction pinch
valve.

1. Align the green band on

the manifold suction
tubing with the green line
on the front of the
console.

2. Above the green band,

hold the suction tubing
with one hand; with the
other hand, stretch the
tubing into the suction
pinch valve.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-7
Connecting the Suction Tubing

3. Connect the green

L-shaped connector on
the suction tube to the
PATIENT port on the
suction canister lid.
4. Make sure all unused
ports on the suction
canister lid are closed,
and the canister lid is
tightly sealed to the
canister.

The following figure shows the suction system as it looks after successful
setup.
Figure 5-1 The assembled
suction system

5-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Connecting the Irrigation Tubing

Connecting the Irrigation Tubing

Warning
To avoid injury to surgical personnel:
• When closing the irrigation pump latch, keep fingers away from the
area between the V-shaped tubing retainers.
• If the pump latch is open, keep fingers away from the pump rollers.

1. Prepare a standard IV administration set and sterile irrigation solution,

and put it on the IV pole located next to the adjustable arm.
2. Connect the irrigation tubing (from the handpiece) to the
CUSA Excel/CUSA Excel+ System.
a. To open the pump
latch (if it is not
already open), rotate ®

the lever to the left.

b. Align the blue stripe

on the irrigation tube
with the blue line on
the front of the
console, then center
the irrigation tubing
inside the pump
rollers, between the V-
shaped tubing
retainers.

Caution
Make sure that the irrigation tubing centers between the V-shaped tubing
retainers before you close the pump latch. Otherwise, the pump latch will pinch
the tubing, preventing the flow of irrigation fluid.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-9
Connecting the Irrigation Tubing

c. To close the pump

latch, rotate the lever
to the right.
3. Remove the cap from the
irrigation tubing.
4. Connect the irrigation
tubing to the IV
administration set tubing.
5. Make sure that the
person assembling the
handpiece has
connected the irrigation
tubing to the handpiece flue.
6. Open the roller clamp on the IV tubing.
The following figure shows the irrigation system as it looks after successful
setup.
Figure 5-2 The assembled
irrigation system

Direction of
Irrigation Flow

5-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Testing the Handpiece

Testing the Handpiece

Warning
Do not use a damaged handpiece with the CUSA Excel/CUSA Excel+ System.
This may result in injury to the patient or surgical personnel.

Warning
When the handpiece is connected to a CUSA Excel/CUSA Excel+ System that
is powered on, but the handpiece is not in use, keep the handpiece away from
the patient. Place the handpiece on a sterile, flat, dry, nonconductive, and highly
visible surface.

Warning
When you connect the handpiece to the console, the handpiece becomes a
functional surgical device.

Caution
When you test the handpiece, 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.

When the handpiece cooling water system fills, the system automatically
proceeds to the next step and illuminates the Test and Prime setpoint
indicators.
1. Press the Test button
(orange box on a black
button at the top of the
amplitude display
column) on the control
panel.

The system automatically activates the handpiece at 100% vibration

for 4 seconds. During the test, green setpoint indicators in the
amplitude display light up to 100% to show that the handpiece is
working correctly.
2. Verify the following:

 The Vibration alarm (cyan) is off.

 The setpoint indicators light up to 100%.
If no Vibration alarm illuminates, and if the setpoint indicators light up
to 100%, the handpiece is working properly. Continue with the system
setup.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-11
Testing the Alarm Tone

If the Vibration alarm illuminates, or if the setpoint indicators do not

light up to 100%, the handpiece is not working properly. This usually
results from an improperly attached tip. To troubleshoot:
 Verify proper tip torquing
 Push the Test button again
 If the problem persists, perform more complete troubleshooting
(see Section 14: Troubleshooting the System)

Testing the Alarm Tone

To verify the alarm tone functions correctly, you must intentionally trigger
an alarm on the CUSA Excel/CUSA Excel+ System, for example,
disconnect the footswitch from console:
1. Disconnect the footswitch from the console at the footswitch connector
(rear panel).
2. The footswitch alarm triggers on the system.

3. Verify that the system sounds the alarm tone four times.
If the alarm tone doesn’t sound, contact your Integra representative.

5-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 When the Surgeon Is Ready

When the Surgeon Is Ready

Warning
Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to
use the system may result in injury to the patient and/or surgical personnel, or
equipment damage.

Warning
The handpiece and handpiece accessories must be sterile before surgical use.

Caution
During surgery, under maximum loading conditions, the
CUSA Excel/CUSA Excel+ console is suitable for ultrasonics activation times of
10 minutes on, 5 minutes off.

1. Make sure the IV administration set roller clamp is open.

2. Prime the irrigation system:

a. Press the Prime button.

The CUSA Excel/CUSA Excel+ System automatically primes the
irrigation system. Setpoint indicators move from 0 to 10 ml on the
irrigation display column. This will take about 1 minute.
b. Make sure irrigation fluid drips from the tip.
If it doesn’t, verify that all connections are tight, then press the
Prime button again.
If fluid appears at the top of the tip before priming is complete, stop
the priming cycle by pressing the Prime button again.
When irrigation prime is complete, the system automatically goes to
Standby mode; it illuminate the orange Standby status indicator and
displays the default setpoint indicator levels for the Aspiration, Irrigation,
Amplitude, and Tissue Selectsettings
Aspiration 100%
Irrigation 3 ml/min
Amplitude 10%
Tissue Select Std
For more information on these settings, see Section 6: Using the
Console Controls.
3. Adjust the Amplitude, Irrigation, Aspiration, and Tissue Select settings
to the surgeon’s requirements.
4. Press the Status button to put the system into the Run mode (green
light).

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-13
When the Surgeon Is Ready

The CUSA Excel/CUSA Excel+ System must remain in Run mode for
a minimum of two minutes (continuous) before it is ready for use; once
the two minutes elapse, the system is ready for use. Vibration will
activate when the surgeon presses the Vibration pedal on the
footswitch.
5. Position the footswitch where it is easily accessible to the surgeon.

6. Position the CUSA Excel/CUSA Excel+ System so that the control

panel is clearly visible to the surgeon at all times. Remove any
obstructions that may block the surgeon’s view of the control panel.
To move the console in the operating room, push it by the handle only.
For guidelines on moving the console within your Healthcare Facility,
see Handling and Transporting of the System, page 15-4.

Caution
Before surgery, apply the brakes locks to all wheels on the console to stop the
wheels from rolling.

Notice
During surgery, do not allow the handpiece tip to touch metal objects such as
staples, clips, instruments, etc. Handpiece tip damage will result.

Warnings Relating to Tip Usage During Surgery

Warning
Touching of the tip of the handpiece by the operator, while the handpiece is
powered on, can result in personal injury.

Warning
When the handpiece is powered on, contact of the tip with a hard surface (e.g. a
metal instrument, tray, staples, clips, instruments, etc) may damage the tip of the
handpiece and require replacement before use.

Warning
CUSA Excel tips utilize silicone flues. Compressing the flue against the side of
the vibrating surface along the length of the tip can cause excessive heating and
potential hazard to adjacent tissue, such as burns.

Warning
Excessive loading of CUSA Excel tips at the surgical site can induce heating
due to vibration and acoustic power transmissions. Thermal management of the
surgical site with the aid of the appropriate irrigation and aspiration settings is
essential.

5-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 When the Surgeon Is Ready

Warning
Avoid excessive lateral loading of CUSA Excel tips.

Warning
Avoid contacting bone with the CUSA Excel tips (excluding SaberTip™).

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 5-15
Notes

5-16 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 6
Using the Console Controls
6

In this section:

• For Your Information, page 6-1

• Adjusting Setpoint Values, page 6-1
• Changing Functions, page 6-3
• Using the Tissue Select Feature, page 6-4
• Using Other Features, page 6-6

For Your Information

This section describes how to use the buttons and indicators on the
control panel. It also describes how to use some of the mechanical
features on the CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator
System console.

Adjusting Setpoint Values

Press the up/down buttons at the bottom of the display to adjust the
setpoint value. Green setpoint indicators illuminate to show the adjusted
setpoint value indicating that the system is ready for use at that value. You
can adjust setpoint values when the:
• System is in Standby status
• System is in Run status
• Surgeon presses the Vibration footswitch pedal

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 6-1
Adjusting Setpoint Values

Aspiration
Aspiration
The aspiration display includes 10 settings, ranging from 10 to 100% of
available suction (up to 660 mm mercury at sea level). The default setting
is 100%. Green up/down arrows mark the aspiration adjustment buttons.

Irrigation Irrigation
The irrigation display includes 10 settings. The irrigation rate ranges from
1 ml/min to 10 ml/min. The default setting is 3 ml/min. Blue up/down
arrows mark the irrigation adjustment buttons.

Amplitude Amplitude
The amplitude display includes 10 settings, from 10 to 100% of the total
amplitude (distance traveled by the tip as it vibrates) available for the
handpiece.The default setting is 10%. Most surgical procedures require a
higher setting. Orange up/down arrows mark the amplitude adjustment
buttons.
The setpoint indicators in the amplitude display show real-time feedback
from the system about the tip performance. The number of setpoint
indicators lit shows the tip performance at any given time.

The Tissue Select Feature

This display includes 5 settings, ranging from Std to ++++. These settings
indicate the tissue selectivity at the handpiece tip. The highest setting
(++++) makes the tip most selective. The default setting is Std (Standard).
For more information on the Tissue Select feature and its settings, see
Using the Tissue Select Feature, page 6-4. Yellow up/down arrows mark
the Tissue Select adjustment buttons.

6-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Changing Functions

Changing Functions
When starting the CUSA Excel/CUSA Excel+ System, switch to Run
status by pressing the green Status button.

Run Run Status

To select the Run status, press the Status button. The system changes
from Standby to Run, turning off the orange status indicator for Standby
and turning on the green status indicator for Run.
The CUSA Excel/CUSA Excel+ System must remain in Run mode for a
minimum of two minutes (continuous) before it is ready for use; once the
two minutes elapse, the system is ready for use. Note that this is
applicable each time the system changes from Standby to Run mode.
To activate the handpiece, press the Vibration (right) pedal on the
footswitch. The tip vibrates. To stop vibration, release the pedal.

Lap On Laparoscopic Mode

In the laparoscopic (Lap) mode, the system provides suction and irrigation
only when it provides vibration. When the surgeon activates vibration by
stepping on the footswitch, the system opens the suction pinch valve.
When the surgeon releases the footswitch, the system stops vibration,
closes the suction pinch valve, and stops irrigation. This feature reduces
the potential for evacuating the pneumoperitoneum.
To select the laparoscopic mode, press the Lap button. The system lights
the Lap indicator (green status indicator below the Lap button).
To turn off the laparoscopic mode, press the Lap button again.

Fast Flush
Fast Flush increases irrigation rate from the setpoint value to greater than
25 ml/min to allow additional irrigation at the surgical site. When the
surgeon activates Fast Flush, the system illuminates all setpoint indicators
in the Irrigation display to show the higher rate. When the surgeon
releases the pedal, the system returns the setpoint indicator display to the
setpoint value.
To activate Fast Flush, press the Fast Flush (left) pedal on the footswitch.
To stop Fast Flush, release the pedal.

Quiet Function
When the surgeon has not pressed either footswitch pedal for at least four
minutes, the system changes to a Quiet Function. In the Quiet Function,
the irrigation and suction pumps run at reduced speed and the machine is
quieter.
As soon as the surgeon presses either pedal, or the operator presses a
control panel button, the system returns to normal operation.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 6-3
Using the Tissue Select Feature

Using the Tissue Select Feature

The Tissue Select feature increases both the inherent selectivity and the
tactile feedback of the vibrating tip by reducing the reserve power the
ultrasonic generator provides to the handpiece.
One of the variables of power consumption is time: reduce time, reduce
power consumed. To reduce power consumption, the ultrasonic generator
reduces the time that it provides electrical power. Specifically, rather than
providing power continuously, it provides power at measured on-off
intervals:

Setting Fragmentation Rate

Std Maximum power

+ Slightly decreased tissue removal

rate, increased tissue selectivity and
tactile feedback

++ and +++ Further decreased tissue removal

rate, increased tissue selectivity and
tactile feedback

++++ slowest tissue removal rate, maximum

selectivity and tactile feedback

Power decreases as on-time decreases.

6-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Using the Tissue Select Feature

At a 100% Amplitude setting, as Tissue Select settings increase, on-time

and reserve power decrease.
The Tissue Select 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 “soft” tissue easily.
• The tip fragments “strong” tissue, but with more difficulty (slower,
requires more surgeon pressure).

Tissue Select Operation

Power is interrupted. The ultrasonic generator provides less reserve
power to the handpiece:
• The tip still fragments “soft” tissue easily.
• But, when it encounters “strong” 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:

Setting Fragmentation Rate On-Time Off-Time

Std Maximum tissue Continuous 0 ms*

removal rate

+ (Cavitation 1) Slightly decreased 40 ms 10 ms

tissue removal rate,
increased tissue
selectivity and tactile
feedback

++ (Cavitation 2) Further decreased 30 ms 10 ms

tissue removal rate,
increased tissue
selectivity and tactile
feedback

+++ (Cavitation 3) Slow tissue removal 20 ms 10 ms

rate, maximum
selectivity and tactile
feedback

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 6-5
Using Other Features

Setting Fragmentation Rate On-Time Off-Time

++++ (Cavitation 4) Slowest tissue removal 10 ms 10 ms

rate, maximum
selectivity and tactile
feedback

*1 ms = 1 millisecond = 1 one-thousandth of a second

Note: The Tissue Select performance specifications are ± 10% of setting.

Using Other Features

The CUSA Excel/CUSA Excel+ console offers other convenient features:
• Adjustable arm height
• Rotating control panel
• Adjustable audible tone (excluding the alarm tone)
• Adjustable IV pole
The next portion of this section describes how to use these features.

Raising/Lowering the Arm

It is possible to raise the arm that supports the control panel to improve
ergonomics or to see the control panel more easily over obstacles. A
locking mechanism holds the arm at one of three positions: normal (lowest
position), 7.6 cm (2.992 in) above normal, and 15.2 cm (5.984 in) above
normal.
Arm release tab
To adjust the arm position:
1. With one hand, press the release tab (rectangular) on the arm housing
to disengage the lock. Once you disengage the lock and begin to move
the arm, it is not necessary to continue pressing the button.
2. With the other hand, grasp the arm and push gently up or down. A
counterweight balances the arm, making it easy to raise or lower.
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.
4. To move the arm to another position, press the release tab again and
continue to gently move the arm.

6-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Using Other Features

Rotating the Control Panel

The control panel rotates and locks into one of four positions:
• Straight forward
• 45° right
• 45° left
• 90° left
To rotate the control panel from one position to another:
1. Grasp the release handle located under the control panel, and pull the
handle toward the front of the console.
2. While holding the handle in this position, rotate the control panel out of
its previous position, then release the handle.
3. Continue to rotate the control panel. At its next locking position, it will
automatically lock into place.

Adjusting the Tone Volume

The CUSA Excel/CUSA Excel+ System includes an audible tone that
sounds in two circumstances:
• When you press the Ultrasonics pedal on the footswitch to activate tip
vibration
• When an alarm activates

Volume Control Ultrasonics Tone

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.

Alarm Tone
This tone (on/off) sounds when an alarm activates. You cannot adjust the
volume of the alarm tones. The alarm tone is less than 80dB.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 6-7
Using Other Features

Adjusting the IV Pole

The IV pole, located at the top rear of the arm housing, adjusts to two
locking positions: down or up. A spring-loaded locking pin slides into a
recessed area on the pole to serve as a lock on the pole’s up/down
motion. A button, located just under the opening in which the pole rests in
the arm housing, releases the locking pin.
When in the down position, the pole also rotates approximately 90°
allowing two positions:
• Parallel to the console
side (position A)
• At a right angle to the
side (position B).
When in the up position, the
pole does not rotate. It
remains at position B. Notice
that the IV bag does not
hang over the console.
Position A
When the unit is shipped, the Position B
IV pole is in position A.

Raise the Pole

To raise the IV pole:

Important
Do not try to raise the pole 1. Grasp the pole and rotate it to position B.
from Position A. Do not try to
rotate the pole when it is in the 2. With one hand, hold the pole; with the other hand, press the button to
upper position. release 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.

Lower the Pole

To lower the IV pole:
5. With one hand, hold the pole; with the other hand, press the button to
release the locking pin.
6. Gently lower the pole. As the pole clears its upper locking position,
release the button.
7. Continue to move the pole downward until it locks into position.

8. After the pole has locked into its lower position, you can rotate it to
position A.

6-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 7
Handpiece Components
7

In this section:

• For Your Information, page 7-1

• Components of Assembled Handpieces, page 7-2
• Additional Handpiece Components, page 7-5

For Your Information

This section presents the items that compose an assembled handpiece for
the CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System,
their physical characteristics, and functions.
This section also presents items that, although not a part of the handpiece
itself, are essential in assembling a handpiece or preparing it for
sterilization.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 7-1
Components of Assembled Handpieces

Components of Assembled Handpieces

The following figure shows the items that comprise a handpiece.

Connector

Cable
O-Rings

Handpiece
Body
Flue

Connecting
Body Tip

Figure 7-1 The components

Nosecone
of a handpiece

Handpiece
The handpiece consists of a connector, a cable, a handpiece body, and a
connecting body (see Figure 7-1). The connector attaches the cable to the
CUSA Excel/CUSA Excel+ console. The cable contains:
• Cooling water tubes (deliver water from the console to cool the
handpiece)
• Electric wires (deliver electric power from console to drive the
handpiece)
The handpiece body contains these working items:
• An electric coil, which creates a magnetic field that excites the
transducer
• A transducer, which converts electric energy to mechanical motion
• Cooling water tubes; the water removes the heat generated by the
transducer in the energy conversion
The connecting body serves as the connecting point for the tip and
transfers the vibrations from the transducer to the tip.
Remember:
• The 23 kHz handpieces are gray with green connectors

7-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Components of Assembled Handpieces

• The 36 kHz handpiece is black with a blue connector

O-Rings
The o-rings fit onto the connecting body in two places:
• A large o-ring fits into a groove on the handpiece housing neck
• A smaller o-ring fits into a groove near the tip end of the connecting
body
The o-rings provide stability for the nosecone and prevent fluid leaks into
the connecting body.
Use different colored o-rings for different frequency handpieces:

23 kHz 36 kHz

Large o-ring black white

Small o-ring green blue

Nosecone
The nosecone attaches to the handpiece and covers the connecting body.
The standard nosecone is nonsterile and reusable. It serves two
purposes:
• Holds the flue in place
Standard Nosecone
• Anchors the suction tube

Tip
The tip, a hollow titanium tube, touches patient tissue. When active, the tip
vibrates at an ultrasonic frequency, causing it to fragment tissue.

Pre-aspiration Holes (x2)

Threads

The tip has two patented pre-aspiration holes, one on either side, which
help to keep the tip clear and provide better visibility at the surgical site.
Threads on one end allow you to attach the tip to the connecting body on
the handpiece.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 7-3
Components of Assembled Handpieces

For more information on various tip diameters and lengths, see Appendix
A, Technical Specifications, in this guide.

Flue
The flue (see Figure 7-1), a translucent silicone tube tapered at one end,
provides a sleeve over the tip. Irrigation fluid flows through an irrigation
connection tube at one end of the flue and down the tip to the surgical site.
Each tip size requires a tip-specific flue; therefore, you will find the tip-
specific flue packaged with the appropriate tip.

Manifold Tubing
The manifold tubing (silicone) consists of two tubes:
• Suction tubing – one end (with a light green fitting) connects to a
suction canister on the console and passes through the suction pinch
valve; the other end connects to the suction port on the handpiece
nosecone.
• Irrigation tubing – one end connects to a standard IV set at the console
and passes through the irrigation pump; the other end connects to the
flue.
The manifold tubing set also includes clips (not shown) that attach the
manifold tubing to the handpiece cable.
Manifold tubing is sterile, single patient use only. You can resterilize
unused manifold tubing once. You have two options for attaching the
tubing to the handpiece:
• Attach the manifold tubing before sterilization
• Attach the manifold tubing in the sterile field
Whether you attach the manifold tubing before or after sterilization,
discard the tubing after one use.
Notice
Attach manifold tubing only if the handpiece is to be sterilized with manifold
tubing at 132°C (270°F). If handpieces are to be sterilized at 134°C (273°F),
assembly of manifold tubing should be done in the sterile field. Refer to
Sterilization Parameters, page 9-1.

Warning
Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed
or re-used may result in the infection of patient (or patient specimen) through
cross-contamination, as well as would incur the risk of modifying the properties
and performance of the device, and of increasing the likelihood of complications
and/or undesirable effects. Once used, devices must be disposed of in
accordance with hospital policies.

7-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Additional Handpiece Components

Additional Handpiece Components

This section presents components that are essential in assembling a
handpiece or preparing it for sterilization.

Nonsterile Tip Torquing Base and Torque Wrench

Use this set only if you are changing tips in the nonsterile field.
The tip torquing base holds the handpiece securely in place while you use
the torque wrench to attach or remove a tip. The base contains a slot for
each handpiece.
The double-headed wrench provides tip torquing and tip removal. The
opening at one end fits 23 kHz tips; at the other end, 36 kHz tips.
Figure 7-2 Tip torquing base and
Slot for 36 kHz
torque wrench for use when
handpiece
changing tips in the nonsterile
field

Slot for 23 kHz

handpieces

Color coding in the tip torquing base slots, on the ends of the torque
wrench, and on each handpiece connector makes it easy to determine
where to put the handpiece in the base and which end of the torque
wrench to use when attaching a tip to a handpiece.
23 kHz green
36 kHz blue

Notice
Do not sterilize the tip torquing base or the torque wrench with steam. Steam
destroys the lubrication in the torquing mechanism, resulting in product damage.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 7-5
Additional Handpiece Components

Sterilizable Torque Bases

Use sterilizable torque bases if you are changing tips in the sterile field.
The sterilizable torque bases hold the handpiece securely in place while
you use a torque wrench to attach or remove a tip. Two bases are
available:
• 23 kHz – This base contains two slots, one for the straight handpiece
and one for the angled handpiece.
• 36 kHz - This base contains a single slot for the handpiece.
Figure 7-3 The sterilizable
23 kHz
torque bases for use when
changing tips in the sterile field

36 kHz

Sterilize the torque bases with steam. To hold the torque bases in position
in the sterilizer case, install the restraining devices in the sterilizer case.
These restraining devices comprise of pegs that snap into the tray and
silicone straps that hold the bases to the pegs, and they are packaged
with the torque bases.

Sterile Torque Wrenches

Use a sterile torque wrench if you are changing tips in the sterile field.
The sterile wrenches provide tip torquing and tip removal. You can use
one sterile wrench to remove and re-install as many as five tips in one
surgical procedure.

Warning
Do not use the sterile wrench for more than one surgical procedure.

7-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Additional Handpiece Components

Two sterile wrenches are available: 23 kHz and 36 kHz.

Figure 7-4 The sterile torque
wrench for use when changing
tips in the sterile field

Sterilizable torque bases and sterile wrenches bear the same color coding
as other CUSA Excel/CUSA Excel+ System components:
23 kHz green
36 kHz blue

Sterilizer Cases
The sterilizer cases hold the handpiece and accessories during
sterilization.
There are separate sterilizer cases for each handpiece:23 kHz (gray case)
and 36 kHz (white case). The dimensions for both cases are:
• length – 54.6 cm (21.5 in.)
• width – 25.4 cm (10 in.)
• depth – 12.7 cm (5 in.)

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 7-7
Additional Handpiece Components

The sterilizer case may be wrapped in hospital approved materials.

Figure 7-5 The 23 kHz

CUSA Excel/CUSA Excel+
handpiece sterilizer case

l
ce
® Ex
SA
CU

7-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 8
Assembling the Handpiece
8

in a Nonsterile Area

In this section:

• For Your Information, page 8-1

• Items Needed for Handpiece Assembly, page 8-2
• Attaching the Tip to the Connecting Body, page 8-4
• Putting On the O-Rings, page 8-6
• Clipping the Manifold Tubing to the Handpiece Cable (Optional),
page 8-6
• Packaging the Handpiece for Sterilization, page 8-7

Notice
Use the information in this section only if the handpiece is to be sterilized with
items, accessories and manifold tubing at 132°C (270°F). If handpieces are to
be sterilized at 134°C (273°F), assembly should be done in the sterile field.
Refer to Sterilization Parameters, page 9-1.

For Your Information

You have two options:
1. NOT Changing Tips in the Sterile Field – If assembling the tip to the
handpiece in a nonsterile area before sterilization, see the following
instructions in this User’s Guide:
 Section 8: Assembling the Handpiece in a Nonsterile Area
 Section 9: Sterilizing Handpieces and Accessories
 Section 10: Completing Handpiece Setup in the Sterile Field

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 8-1
Items Needed for Handpiece Assembly

2. Assembling or Changing Tips in the Sterile Field – For instructions on

how to assemble and disassemble the handpiece as part of changing
tips in the sterile field, refer to Section 11: Assembling or Changing
Tips in the Sterile Field.
• Important notes: Use the same procedure to assemble the 23 kHz
straight, 23 kHz angled, and 36 kHz straight handpieces.
• Handpiece cable connectors, tip pack packaging, manifold tubing
packaging, nosecone packaging, slots in the tip torquing base, torque
wrench heads, and sterilizer tray lids are color coded:
23 kHz green
36 kHz blue
• Recommended: When you assemble a handpiece, assemble at least
one backup handpiece.

Items Needed for Handpiece Assembly

The following figures illustrate the items you need to assemble the
handpiece. The tip, o-rings, and flue are part of tip packs.
Figure 8-1 The items you need Handpiece
to assemble a handpiece:
handpiece, nosecone, and tip
pack

Standard
nosecone

8-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Items Needed for Handpiece Assembly

(Content of Tip Pack) Tip

O-rings

Flue

Tip cleaner
(shipped
inside the
flue)

Figure 8-2 Tip torquing base and

torque wrench (for use in non-
sterile field)

You also need a tip torquing base and torque wrench to assemble a
handpiece.

Manifold tubing is sterile, single use only. Discard the manifold tubing after
one use. You have two options for attaching the tubing to the handpiece:
• Attach the manifold tubing before sterilization
• Attach the manifold tubing in the sterile field
Notice
Attach manifold tubing before sterilization only if the handpiece is to be sterilized
with manifold tubing at 132°C (270°F). If handpieces are to be sterilized at
134°C (273°F), assembly of manifold tubing should be done in the sterile field.
Refer to Sterilization Parameters, page 9-1.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 8-3
Attaching the Tip to the Connecting Body

Figure 8-3 Manifold tubing

Warning
Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed
or re-used this may result in the infection of patient (or patient specimen)
through cross-contamination, as well as would incur the risk of modifying the
properties and performance of the device, and of increasing the likelihood of
complications and/or undesirable effects. Once used, devices must be disposed
of in accordance with hospital policies.

Attaching the Tip to the Connecting Body

1. Thread the tip of choice
onto the handpiece
connecting body. Turn
the tip until it is finger
tight.

8-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Attaching the Tip to the Connecting Body

2. Locate the slot in the tip

torquing base that
matches the color on the
handpiece connector
(23 kHz – green;
36 kHz – blue). Put the
handpiece in the tip
torquing base so that the
metal connecting body
fits snugly in the metal
end of the slot.

3. Hold the handpiece in place in the tip torquing base.

Caution
To avoid product damage, NEVER hold the handpiece in your hand while
using the torque wrench to tighten or loosen the tip.

4. Match the colored end of

the torque wrench with
the handpiece color. Slide
the color coded side of
the wrench over the tip,
being careful not to
damage the tip, until the
hex in the wrench
engages the hex of the
tip.
5. Rotate the wrench Second Click
clockwise until you feel
and hear a click. Rotate First Click
again until you feel and
hear a second click.

Warning
Turning the torque wrench
further clockwise will damage
the handpiece.

6. Remove the wrench from

the tip.
7. Remove the handpiece from the tip torquing base.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 8-5
Putting On the O-Rings

Putting On the O-Rings

1. Locate the o-rings for the handpiece you are assembling:

23 kHz 36 kHz

Large o-ring black white

Small o-ring green blue

2. Slide the larger o-ring

over the connecting body
and into the groove in the
neck of the handpiece.
Slide the smaller o-ring
into the groove in the
metal connecting body.

Caution
Do not assemble the nosecone to the handpiece until both the handpiece and
nosecone are sterile.

Clipping the Manifold Tubing to the Handpiece Cable

(Optional)
Manifold tubing is sterile, single patient use only. You can sterilize unused
manifold tubing once. You have two options for attaching the tubing to the
handpiece:
• Attach the manifold tubing before sterilization
• Attach the manifold tubing in the sterile field
Whether you attach the tubing before or after sterilization, discard it after
one use.
Warning
Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed
or re-used this may result in the infection of patient (or patient specimen)
through cross-contamination, as well as would incur the risk of modifying the
properties and performance of the device, and of increasing the likelihood of
complications and/or undesirable effects. Once used, devices must be disposed
of in accordance with hospital policies.

8-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Packaging the Handpiece for Sterilization

Notice
Attach manifold tubing before sterilization only if the handpiece is to be sterilized
with manifold tubing at 132°C (270°F). If handpieces are to be sterilized at
134°C (273°F), assembly of manifold tubing should be done in the sterile field.
Refer to Sterilization Parameters, page 9-1.

If you decide to clip the manifold tubing onto the handpiece cable before
sterilization, follow this procedure:
1. Remove the manifold tubing with clips from the packaging. Uncoil the
tubing.
2. Snap the handpiece clip
in place on the handpiece
housing.

3. Push one to three

manifold tubing clips onto
the handpiece cable.
Note: It is only necessary
to attach one to three
clips, but you can attach
all five clips in the
package.

Packaging the Handpiece for Sterilization

After you have assembled the handpiece, prepare it for sterilization.
Integra provides sterilizer cases for steam sterilization of the CUSA®
Excel/CUSA® Excel+ System handpieces. These cases protect the
handpieces during sterilization and during transfer to the sterile field. The
case for the 23 kHz handpiece is gray; for the 36 kHz handpiece, white.

Items Needed
You will need the sterilizer case provided by Integra.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 8-7
Packaging the Handpiece for Sterilization

Figure 8-4 The sterilizer case

l
ce
® Ex
SA
CU

1. Put the handpiece into the case first. Align the handpiece with the
outline on the case bottom. Secure the handpiece with the silicone
strap.
2. Place the nosecone and flue with the tip cleaner in the handpiece
compartment.
3. Close the protective cover over the handpiece.

4. Coil the cable and manifold tubing (if attached) around the inside of the
case.
5. Put the handpiece connector in the center compartment and secure it
in place.
6. Put on the lid. Close and latch the case.

8-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Packaging the Handpiece for Sterilization

Figure 8-5 The handpiece and

connector secured into the
sterilizer tray

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 8-9
Notes

8-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 9
Sterilizing Handpieces and
9

Accessories

In this section:

• For Your Information, page 9-1

• Sterilization Parameters, page 9-1
• Sterilizing the Handpiece with Steam, page 9-3

For Your Information

After preparing the handpiece, sterilize it using steam. This section
describes the steam sterilization parameters.

Sterilization Parameters
Sterilize CUSA® Excel/CUSA® Excel+ handpieces and accessories with
steam. Sterilizing the handpiece, along with manifold tubing, increases the
required sterilization times. For information on preparing the handpiece for
sterilization, see Packaging the Handpiece for Sterilization, page 11-15.
The following tables provide the minimum parameters:

Packaging
Wrapped: Sterilizer case double wrapped in hospital CSR material.
Flash: Sterilizer case unwrapped.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 9-1
Sterilization Parameters

Handpieces without Accessories

Packaging Temp Type Time Dry Cycle

Wrapped 132°C or Prevac 4 min 20 min

270°F

134°C or Prevac 18 min 20 min

273°F Autoclave/
Vacuum

Flash 132°C or Prevac 4 min none

(Unwrapped) 270°F

134°C or Prevac 18 min 20 min

273°F Autoclave/
Vacuum

Handpieces with Accessories

Packaging Temp Type Time Dry

Cycle

Wrapped 132°C or Prevac 4 min 20 min

270°F

Flash 132°C or Prevac 4 min none

(Unwrapped) 270°F

Notice
Accessories include the nosecone, manifold tubing, tip pack contents (tip, flue,
tip cleaner, o-rings) and sterilizable tip torquing base.

For information on the validation procedure for the steam sterilization

parameters defined here, see Validation of Steam Sterilization
Parameters, page B-1.

9-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Sterilizing the Handpiece with Steam

Sterilizing the Handpiece with Steam

Sterilizing the handpiece with steam depends on the following factors:
• Temperature
• Exposure time
• Population and resistance of resident bioburden
• Method of air removal from the autoclave
Use the validated steam sterilization cycle parameters in these
instructions. If you deviate from this recommended method of sterilizing, it
is your Health Care Facility’s responsibility to validate the deviations.
For sterilizing the handpiece with steam, do not exceed 138° C (280°F).
After steam sterilization, the handpiece cable may appear collapsed. This
is normal. The cable regains its shape in about one hour. This does not
affect the handpiece performance or safety.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 9-3
Notes

9-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 10
Completing Handpiece Setup
10

in the Sterile Field

In this section:

• For Your Information, page 10-1

• Quick Reference – Setup, page 10-2
• Completing the Handpiece Assembly, page 10-2

For Your Information

This section describes how to complete the handpiece setup in the sterile
field. It begins with the arrival of the sterilized handpiece and accessories
in the operating room. It ends with the handpiece ready to be connected to
the console.

Notice
Retaining a spare handpiece in the sterile field is highly recommended.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 10-1
Quick Reference – Setup

Quick Reference – Setup

Use this list if you are a knowledgeable user who needs only a reminder of
the steps to set up the CUSA® Excel/CUSA® Excel+ System.

Handpiece Assembly
1. Attach a standard nosecone onto the handpiece.

2. Attach the flue.

3. Attach the sterile manifold tubing (if not attached before sterilization).

4. Attach the aspiration and irrigation tubes at the handpiece.

Completing the Handpiece Assembly

You have the option of attaching manifold tubing to the handpiece cable
before or after sterilization. If you chose to attach the tubing after
sterilization, you must attach it in the sterile field.

Items Needed
You need the following items to set up the handpiece for surgery:
• Standard nosecone
• Flue
• Manifold tubing

10-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Completing the Handpiece Assembly

Attach a Nosecone
1. Attach a standard
nosecone. Holding the
handpiece, insert the tip
into the nosecone.

2. Align the dot on the

nosecone with the dot on
the neck of the
handpiece.
3. Push the nosecone onto
the handpiece so that the
dots are on top of each
other.

4. Twist the nosecone

clockwise until it locks
into place.

5. The dot on the nosecone

must now align with the
dot on the handpiece.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 10-3
Completing the Handpiece Assembly

6. Remove the tip cleaner,

and slide the flue that
corresponds to the
selected tip over the tip
and onto the nosecone.
Make sure to push the
flue base completely over
the nosecone base, and
that the end of the flue
lines up with the
pre-aspiration holes.

10-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Completing the Handpiece Assembly

Clip the Manifold Tubing to the Handpiece Cable

If you receive the sterilized handpiece without the manifold tubing already
clipped onto the handpiece cable, you must attach the manifold tubing
now. Follow this procedure:
1. Remove the manifold tubing with clips from the packaging. Uncoil
some of the tubing.
2. Snap the handpiece clip
in place on the handpiece
housing.

3. Insert the irrigation tube

from the flue into the
handpiece clip.

4. Connect the manifold irrigation tubing to the Luer fitting on the

handpiece flue:
(Viewed from rear)
a. Connect the Luer
fitting.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 10-5
Completing the Handpiece Assembly

b. Twist the knob

clockwise to lock the
fitting.

5. Connect the manifold

suction tubing and clip to
the suction port in the
nosecone.

6. Push one to three

manifold tubing clips onto
the handpiece cable.
Note: It is only necessary
to attach one to three
clips, but you can attach
all five clips in the
package.

7. Hand off the remaining manifold tubing, handpiece cable, and

handpiece electrical connector to the circulator.

10-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 11
Assembling or Changing
11

Tips in the Sterile Field

In this section:

• For Your Information, page 11-1

• Items Needed to Change Tip in Sterile Field, page 11-2
• Disassembling Handpiece to Change Tips in the Sterile Field,
page 11-10
• Disassembling Handpiece After the Surgical Procedure,
page 11-13
• Resterilizing the Handpiece, page 11-14
• Packaging the Handpiece for Sterilization, page 11-15
• Packaging the Base for Sterilization, page 11-16
• Sterilize the Handpiece and Base, page 11-17

For Your Information

You have two options:
1. Assembling or Changing Tips in the Sterile Field – This section
explains how to assemble and disassemble the handpiece as part of
changing tips in the sterile field.
2. NOT Changing Tips in the Sterile Field – If assembling the tip to the
handpiece in a nonsterile area before sterilization, see the following
instructions:
 Section 8: Assembling the Handpiece in a Nonsterile Area
 Section 9: Sterilizing Handpieces and Accessories

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-1
Items Needed to Change Tip in Sterile Field

 Section 10: Completing Handpiece Setup in the Sterile Field

Important notes:
• Use the same procedure to assemble the 23kHz straight, 23kHz
angled, and 36kHz handpieces
• Handpiece cable connectors, manifold tubing packaging, tip/flue
packaging, nosecone packaging, slots in the tip torquing bases, and
sterile torque wrenches are color coded:
23kHz green
36kHz blue
• Recommended: When you assemble a handpiece, assemble at least
one backup handpiece.

Items Needed to Change Tip in Sterile Field

You need the following items to change tips in the sterile field:
• Sterilized handpiece(s)
• Sterilized standard nosecone
• Sterile tip/flue pack(s) or sterilized extended life tips and flues
• Sterilized tip torquing base
• Sterile torque wrench (23 kHz or 36 kHz)
• Sterile manifold tubing
The following figures illustrate these items.
Figure 11-1 The sterilized
handpiece

11-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Items Needed to Change Tip in Sterile Field

Figure 11-2 The sterilized

standard nosecone

The contents of sterile tip/flue packs are sterile, single use only. You can
resterilize unused tips and flues once.
The contents of extended life tip/flue packs are nonsterile. You can use
them six times. If you use extended life tips and intend to attach the tip in
the sterile field, ensure tips and flues are sterile before they are introduced
to the sterile field.
You have two options for attaching tips to the handpiece:
• Attach the tip in the sterile field
• Attach the tip before sterilizing the handpiece (If you use this option, do
not change tips in the sterile field because the area under the tip
threads will not be sterile)
Figure 11-3 Sterile tip/flue pack
contents. The tip cleaner is inside
the flue.

Tip

O-rings
Flue

Tip
cleaner

Steam sterilize the tip torquing base before each surgical procedure in
which you change tips in the sterile field.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-3
Items Needed to Change Tip in Sterile Field

Figure 11-4 Sterilizable tip

torquing base 23 kHz
(Green)

36 kHz
(Blue)

You can use the sterile torque wrench to change as many as five tips in
one surgical procedure. Do not use the sterile torque wrench in more than
one surgical procedure. Do not sterilize the sterile torque wrench; dispose
of the used sterile torque wrench in accordance with your Healthcare
Facility protocols.
Figure 11-5 Sterile torque
wrench (23 kHz or 36 kHz)

Manifold tubing is sterile, single patient use only. You can resterilize
unused manifold tubing once. You have two options for attaching the
tubing to the handpiece:
• Attach the manifold tubing in the sterile field
• Attach the manifold tubing before sterilizing the handpiece
Figure 11-6 Sterile manifold
tubing

11-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Assembling the Tip

Notice
Attach manifold tubing only if the handpiece is to be sterilized with manifold
tubing at 132°C (270°F). If handpieces are to be sterilized at 134°C (273°F),
assembly of manifold tubing should be done in the sterile field. Refer to
Sterilization Parameters, page 9-1.

Warning
Single Use devices are for single patient use only. Do not reprocess or re-use.
Devices (s) is (are) intended to be used for one procedure only. If reprocessed
or re-used this may result in the infection of patient (or patient specimen)
through cross-contamination, as well as would incur the risk of modifying the
properties and performance of the device, and of increasing the likelihood of
complications and/or undesirable effects. Once used, devices must be disposed
of in accordance with hospital policies.

Assembling the Tip

For this procedure, use the sterile, disposable torque wrench (C5601 for
23 kHz or C5602 for 36 kHz) and the sterilizable torque base (C5623 for
23 kHz or C5636 for 36 kHz).

Warning
The handpiece and handpiece accessories must be sterile before surgical use.

Attach the Tip and O-rings

1. Thread the tip of choice
onto the handpiece Connecting
connecting body. Turn the body
tip until it is finger tight.

2. The sterilized torque

base should be in the sterilizer tray. Verify that the handpiece support
color on the torque base matches the color on the handpiece
connector (23 kHz – green; 36 kHz – blue). Remove the sterilized
torque base from the sterilizer tray.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-5
Assembling the Tip

3. Put the handpiece in the

torque base so that the
metal connecting body
fits snugly in the metal
slot at the end of the
support.

4. Match the colored ring on

the sterile torque wrench Green ring on head of 23 kHz wrench
with the handpiece
connector color or
handpiece support color
on the torque base. Slide
the color coded side of
the wrench over the tip,
being careful not to
damage the tip, until the
hex in the wrench
engages the hex of the
tip.
Blue ring on head of 36 kHz wrench

5. Hold the handpiece in

place in the tip torquing base.

Caution
To avoid product damage, NEVER hold the handpiece in your hand while
using the torque wrench to tighten or loosen the tip.

6. Rotate the wrench Second Click

clockwise until you feel
and hear one click. First Click
Rotate again until you
feel and hear a second
click.

Warning
Turning the torque wrench
further clockwise will damage
the handpiece.

11-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Assembling the Tip

7. Carefully remove the sterile wrench from the tip.

8. Remove the handpiece from the tip torquing base.

9. Locate the o-rings for the handpiece you are assembling:

23 kHz 36 kHz

Large o-ring black white

Small o-ring green blue

10. Slide the larger o-ring

over the connecting body
and into the groove in the
neck of the handpiece.
Slide the smaller o-ring
into the groove in the
metal connecting body.

Attach a Nosecone and Flue

Attach a standard nosecone.

1. Holding the handpiece,

insert the tip into the
nosecone.

2. Align the dot on the

nosecone with the dot on
the neck of the
handpiece.
3. Push the nosecone onto
the handpiece so that the
dots are on top of each
other.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-7
Assembling the Tip

4. Twist the nosecone

clockwise until it locks
into place.
The dot on the nosecone
must now align with the
dot on the handpiece.

5. Remove the tip cleaner from the flue and set it aside. You may need it
during the surgical procedure to remove tissue blockage from the tip,
the suction connection to the handpiece, or both.
6. Slide the flue that
corresponds to the
selected tip over the tip
and onto the nosecone.

Markings on the flue indicate the tip the flue should cover:

S Standard Tip

Mi MicroTipTM, ShearTipTM,
SaberTipTM

Mit MicroTipTM Plus

P PrecisionTipTM

Ma MacroTipTM

Make sure to push the flue base completely over the nosecone base,
and that the end of the flue lines up with the pre-aspiration holes.

11-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Assembling the Tip

Attach the Manifold Tubing

If you receive the sterilized handpiece without the manifold tubing already
clipped onto the handpiece cable, you must attach the manifold tubing
now. Follow this procedure:
1. Remove the manifold tubing with clips from the packaging. Uncoil
some of the tubing.
2. Snap the handpiece clip
in place on the handpiece
housing.

3. Insert the irrigation tube

from the flue into the
handpiece clip.

4. (Viewed from rear) Connect the manifold irrigation tubing to the Luer
fitting on the handpiece flue.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-9
Disassembling Handpiece to Change Tips in the Sterile Field

5. Connect the manifold

suction tubing and clip to
the suction port in the
nosecone.

6. Push one to three

manifold tubing clips onto
the handpiece cable.
Note: It is only necessary
to attach one to three
clips, but you can attach
all five clips in the
package.

Disassembling Handpiece to Change Tips in the Sterile Field

Use this procedure only if you are disassembling the handpiece as part of
changing tips in the sterile field. To disassemble the handpiece at the end
of the surgical procedure, see Section 13: Disassembling and Cleaning
Handpieces.
1. Press the Status button to
put the system in Status button
Standby.

11-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Disassembling Handpiece to Change Tips in the Sterile Field

Disconnect the Manifold Tubing

1. (Viewed from rear) Disconnect the irrigation tubing from the handpiece
flue.

2. Remove the flue irrigation tube from the handpiece clip.

3. Remove the flue and set it aside.

4. Disconnect the manifold

suction tubing and its clip
from the handpiece and
nosecone.

Remove the Nosecone, O-rings, and Tip

1. Remove the standard nosecone:

a. Release the nosecone

by twisting it
counterclockwise.
b. Pull the nosecone
away from the
handpiece and set it
aside.

DO NOT DISCARD A
STANDARD
NOSECONE.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-11
Disassembling Handpiece to Change Tips in the Sterile Field

2. Locate the sterile torque base in which the handpiece support color
matches the color on the handpiece connector (23 kHz – green;
36 kHz – blue).
3. Put the handpiece in the
torque base so that the
metal connecting body
fits snugly in the metal
slot at the end of the
support.

4. Match the colored ring of

the sterile torque wrench Green ring on head of 23 kHz wrench
with the handpiece
connector color or
handpiece support color
on the torque base. Slide
the color coded side of
the wrench over the tip
until the hex in the
wrench engages the hex
of the tip.

Blue ring on head of 36 kHz wrench

5. Hold the handpiece securely in place in the torque base.

Caution
To avoid product damage, NEVER hold the handpiece in your hand while
using the torque wrench to tighten or loosen the tip.

6. Rotate the wrench

counterclockwise until the
tip is loose.

7. Carefully remove the sterile wrench from the tip.

8. Remove the handpiece from the tip torquing base.

11-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Disassembling Handpiece After the Surgical Procedure

9. Unscrew the used tip. Set

the tip and flue aside for
further use or disposal at
the end of the surgical
procedure.

10. Using a soft cloth, wipe

the handpiece connecting Connecting body surface
body surface to remove
gross contaminants.
If reassembling a used tip
to the handpiece, remove
gross contaminants from
the tip connecting surface Tip connecting surface
by wiping with a soft
cloth.
i

To reassemble the handpiece in the sterile field, refer to the Assembly

earlier in this section.

Disassembling Handpiece After the Surgical Procedure

If you are disassembling the handpiece at the end of the surgical
procedure, discard the following items in accordance with your Healthcare
Facility’s protocols:
• Flue(s)
• Manifold tubing
• Handpiece o-rings
• Tip(s) removed from the handpiece
• Sterile torque wrench
• Tip cleaner

Do not discard these items:

• Handpiece
• Standard nosecone
• Sterilizable torque base
Note: Do not discard the reusable tip at the end of the surgical procedure.
Reusable tips can be reused six times.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-13
Resterilizing the Handpiece

See section Disassembling the Handpiece, page 13-2 for further

information on disassembling handpieces.
When you have disassembled the tip from the handpiece, clean the
handpiece and the sterilizable torque base, following the cleaning
procedures described below.

Resterilizing the Handpiece

Clean the handpiece, either manually or by using an automatic washer.
For instructions on handpiece cleaning, refer to Cleaning the Handpiece,
page 13-4.

Resterilizing the Sterilizable Torque Base

This procedure was developed in accordance with the professional
recommendations of the Association for the Advancement of Medical
Instrumentation (AAMI) and the Association of periOperative Registered
Nurses (AORN).

23 kHz 36 kHz

11-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Packaging the Handpiece for Sterilization

Cleaning efficacy has been validated using enzymatic cleaning agents (for
example, Klenzyme® and Enzol®) according to the manufacturer's
instructions.
After disassembling the tip from the handpiece, clean, then sterilize, the
sterilizable torque base. Refer to the cleaning instructions below.

Clean the Base

Notice
Product damage will result if you do not follow these notices when cleaning the
handpiece:
• Do not use ultrasonic washers
• Do not use chlorinated substances such as bleach solution
• Do not clean the handpiece with abrasives such as Ajax, Comet, or steel wool

1. Remove all gross matter (blood, mucous, and tissue):

a. Dampen a soft cloth with a cleaning agent.

b. Thoroughly wipe all surfaces of the base. Follow the procedures

approved by your Healthcare Facility.
2. Soak at least two minutes in an enzymatic cleaning agent (for
example, Klenzyme or Enzol) according to the manufacturer's
instructions.
3. Scrub all surfaces with a small soft brush.

4. Rinse thoroughly with water.

5. Dry with a clean soft cloth.

Packaging the Handpiece for Sterilization

After you have cleaned the disassembled handpiece, prepare it for
sterilization. Integra provides sterilizer cases for steam sterilization of the
handpieces. They protect the handpieces during sterilization and during
transfer to the sterile field. The case for the 23 kHz handpiece is gray; for
the 36 kHz handpiece, white.

Notice
Use the information in this section only if the handpiece is to be sterilized with
items, accessories and manifold tubing at 132°C (270°F). If handpieces are to
be sterilized at 134°C (273°F), sterilize the handpiece separate from the
accessories and manifold tubing. Refer to Sterilization Parameters, page 9-1.

1. Put the disassembled handpiece into the case first. Align the
handpiece with the outline on the case bottom. Secure the handpiece
with the silicone strap.
2. Close the protective cover over the handpiece.

3. Place the nosecone into the opening in the protective cover.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-15
Packaging the Base for Sterilization

4. Coil the cable and manifold tubing (if attached) around the inside of the
case.
5. Put the handpiece connector in the center compartment and secure it
in place.
Figure 11-7 The handpiece and
connector secured into the
sterilizer tray

Do not close the sterilizer case until you clean and load the sterilizable
torque base.

Packaging the Base for Sterilization

Notice
Package the torque base with handpiece only if the handpiece is to be sterilized
with the torque base at 132°C (270°F). If the handpiece is to be sterilized at
134°C (273°F), sterilize the torque base separate from the handpiece. Refer to
Sterilization Parameters, page 9-1.

1. Load the sterilizable torque base into the CUSA® Excel/CUSA® Excel+
sterilizer tray and secure it with the silicone strap.

11-16 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Sterilize the Handpiece and Base

2. Put on the lid. Close and latch the sterilizer case

23kHz 36kHz

Sterilize the Handpiece and Base

Steam sterilize the handpiece and base using procedures approved by
your Healthcare Facility.
For complete information on sterilization parameters, see Sterilizing
Handpieces and Accessories, page 9-1.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 11-17
Notes

11-18 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 12
Shutting Down, Disconnecting
12

and Cleaning the Console

In this section:

• Shutting Down the System, page 12-2

• Disconnecting Suction Tubing, Irrigation Tubing, and the
Handpiece, page 12-3
• Cleaning the Console, page 12-5

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 12-1
Shutting Down the System

Shutting Down the System

1. Press the Status button
Status Button
on the system control
panel.
This changes the system
from Run mode to
Standby mode.

2. Turn off ( ) the System

Power Switch. ®

The system turns on the

Wait and Cooling Water
status indicators and
automatically drains the
handpiece cooling water.
This takes about one
minute. The Wait status
indicator flashes.
System Power
Switch

3. While the system displays the flashing Wait status indicator and the
Cooling Water status indicator, remove the green-banded suction
tubing from the pinch valve.
When the flashing Wait status indicator goes off, the control panel goes
blank and the system automatically powers down. When this occurs, the
pinch valve automatically closes. If you haven’t already removed the
suction tubing before the pinch valve closes, use the valve override button
on the front of the pinch valve to open the valve and remove the tubing.
Manually opening the valve requires a strong push on the button.
Disconnect the tubing and the handpiece, as described in the next
procedure. Power down the system from the rear of the unit and unplug
the system from the wall receptacle.

Notice
Do not disconnect the handpiece until the control panel goes completely blank.
Otherwise, product damage may result.

12-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Disconnecting Suction Tubing, Irrigation Tubing, and the Handpiece

Disconnecting Suction Tubing, Irrigation Tubing, and the

Handpiece
1. Disconnect the green
L-shaped connector on the
manifold suction tubing from
the suction canister. Then
put the cap (if available) on
the canister lid.

2. Disconnect the green

L-shaped connector on the
contamination guard tubing
from the suction canister.
Then put the cap (if
available) on the canister lid.
Do not discard the
contamination guard or
tubing.
After each surgical
procedure, remove and
dispose of the suction canister (as per hospital bio-hazard waste
protocols).

3. Close the roller clamp on the IV tubing.

4. Disconnect the IV tubing from the irrigation tubing.

5. Open the irrigation pump
latch.
®

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 12-3
Disconnecting Suction Tubing, Irrigation Tubing, and the Handpiece

6. Remove the blue-striped

manifold irrigation tubing.

7. Close the irrigation pump

latch.

Warning
To avoid injury to surgical
personnel:
• When closing the
irrigation pump latch,
keep fingers away from
the area between the V-
shaped tubing retainers.
• If the pump latch is open,
keep fingers away from
the pump rollers.

8. After all indicators on the

control panel are off,
remove the handpiece:
a. Turn the handpiece
connector ring
counterclockwise.
b. Remove the connector
from the console.

Caution
Sharp edge at the handpiece
connection point.

9. Remove and discard disposable components from the handpiece:

Important
A standard nosecone is not a  Disconnect the aspiration line from the nosecone.
disposable component. Do not
discard a standard  Remove the flue from the tip.
nosecone.  Remove the tip from the handpiece.
 Unclip the manifold tubing from the handpiece and handpiece
cable.
Discard all of these items in the patient’s biohazard waste container.
Do not discard a reusable tip. Reusable tips can be reused six times.

12-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Cleaning the Console

10. Empty cooling water from the cooling water reservoir:

a. Press the button (just above the reservoir) on the Arm Housing to
release the fittings inside the housing.
b. Slide the reservoir toward the rear of the console, then remove it
from its slot.
c. Gently open the black rubber lid on the reservoir top and discard
the distilled water.
d. Gently close the black rubber lid.

e. Slide the empty reservoir back into the slot at the base of the
adjustable arm until it snaps into place.
DO NOT DISCARD THE COOLING WATER RESERVOIR.

Cleaning the Console

Clean the CUSA® Excel/CUSA® Excel+ System surfaces and power cord.
Use a mild cleaning solution or disinfectant, and a soft cloth.

Warning
Electric Shock Hazard – Always unplug the CUSA Excel/CUSA Excel+ System
before cleaning it.

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 because it will cause
discoloration. Do not allow fluids to enter the chassis.

1. Unplug the unit power cord from the wall receptacle.

2. Using standard procedures for your facility, thoroughly wipe all

surfaces, cords, and the footswitch with a cleaning solution or
disinfectant.
3. To ensure sufficient conductivity, clean the four wheels at the base of
the console. Make sure that the surface of the wheels are free from dirt
and dust. Make sure that the surface is completely dry before using the
system again.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 12-5
Notes

12-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 13
Disassembling and Cleaning
13

Handpieces

In this section:

• For Your Information, page 13-1

• Disassembling the Handpiece, page 13-2
• Cleaning the Handpiece, page 13-4
• Permitted Number of Reprocessing Cycles for Handpieces when
Cleaned with an Automatic Washer, page 13-6
• Cleaning the Tip Torquing Set, page 13-7

For Your Information

This section describes how to disassemble and clean the handpiece and
tip torquing set.
Here is some information that may help as you disassemble the
handpiece:
• Use the same disassembly procedure for all handpieces: 23 kHz
straight, 23 kHz angled, and 36 kHz straight.
• Handpiece cable connectors, tip pack packaging, manifold tubing
packaging, nosecone packaging, slots in the tip torquing base, torque
wrench heads, and sterilizer tray lids are color coded:
23 kHz green
36 kHz blue

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 13-1
Disassembling the Handpiece

Disassembling the Handpiece

As you disassemble the handpiece, you keep some parts, and discard
others. Table 13-1 shows the parts to keep and to discard (in the order in
which you remove them):
Table 13-1 What to discard and
what to keep
What to Discard What to Keep

manifold tubing with clips handpiece

flue standard nosecone

tip cleaner

o-rings

tip

Note: Do not discard a reusable tip. Reusable tips can be reused six
times.
When cleaning handpieces, wear protective clothing, gloves, and safety
glasses in accordance with your hospital’s cleaning policy.
1. Using a soft cloth
moistened with a
germicidal solution, wipe
the handpiece to remove
gross contaminants.

2. Remove the flue, if not already removed.

3. Remove the nosecone:

a. Release the
nosecone by twisting
it counterclockwise.
b. Pull the nosecone
away from the
handpiece.

DO NOT DISCARD A STANDARD NOSECONE.

13-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Disassembling the Handpiece

4. Remove the o-rings and discard them.

5. Locate the slot in the tip

torquing base that
matches the color on the
handpiece connector
(23 kHz – green;
36 kHz – blue). Put the
handpiece in the tip
torquing base so that the
metal connecting body
rests snugly in the metal
end of the slot.

6. Hold the handpiece in place in the tip torquing base.

Caution
To avoid product damage, NEVER hold the handpiece in your hand while
using the torque wrench to tighten or loosen the tip.

7. Match the colored end of

the torque wrench with
the handpiece color. Slide
the color coded side of
the wrench over the tip
until the hex in the
wrench engages the hex
of the tip.

8. Rotate the wrench

counterclockwise until the
tip is loose.

9. Remove the handpiece

from the tip torquing
base.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 13-3
Cleaning the Handpiece

10. Unscrew the tip.

When you have disassembled the handpiece, clean the handpiece, the tip
torquing base, and the torque wrench as described in the procedures
below.

Cleaning the Handpiece

The handpiece can be cleaned manually or cleaned using an automatic
washer.

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 washers.
• Do not use chlorinated substances such as bleach solution.
• Do not clean the handpiece with abrasives such as Ajax®, Comet®, or steel
wool.

Clean the Handpiece - Manual Cleaning

1. For general cleaning, using a soft cloth, manually clean the handpiece,
handpiece cable, handpiece electrical connector, and standard
nosecone with a mild cleansing solution (neutral detergent) or blood
dissolving detergent according to hospital policy.
2. Using a soft cloth, pipe
cleaner, or cotton tipped
applicator, manually
clean the lumen, internal
threads, and face of the
connecting body.

13-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Cleaning the Handpiece

Rinse the nosecone,

connecting body, handpiece
housing, and handpiece
cable thoroughly with clean,
running water.

3. Manually wipe the

handpiece electrical
connector with a cloth moistened with water.
4. Using a soft cloth, dry the nosecone, connecting body, handpiece
housing, handpiece cable, and handpiece electrical connector.
Notice
For both the handpiece and the ELT tips, to clean threads and to polish connecting
surfaces, you can use the Handpiece/Tip Maintenance Kits (Ref/Cat C0023 for 23 kHz
and 36 kHz).

Clean the Handpiece - Automatic Washer

Prior to the Automatic Washer cycle remove gross contaminants by wiping
the handpiece with soft cloth moistened with germicidal solution.
To clean the handpiece, use a recognized medical device detergent that is
pH neutral and non-enzymatic. For users in the EU the detergent should
be CE Marked. Follow the instructions for use, indications, including
warning and handling information provided by the detergent manufacturer.
The Handpiece cleaning process validation uses Thermoton® NR
detergent, as follows:

Cleaning Stage Attribute Setting

Phase 1 (Pre-wash) Pre-wash water temperature 43°C

Pre-wash time 7 minutes

Phase 2 (main Washing temperature 55°C

wash)
Washing hold time 5 minutes

Detergent treatment Thermoton®

NR

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 13-5
Cleaning the Handpiece

Phase 3 (final rinse) Rinsing water temperature 93°C

Rinsing water time 5 minutes

Phase 4 (drying) Drying temperature 98.8°C

Drying time 20 minutes

To ensure thorough cleaning, place the handpiece on the automatic

washer tray as follows:
• Put the handpiece in the center area of the tray.
• Arrange the handpiece cable in loose coils around the handpiece. Do
not allow the cable to overlap.
• Position the handpiece connector so that it does not rest on the
handpiece or cable.
The following is an example of correct placement of the handpiece on an
automatic washer tray:

13-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Permitted Number of Reprocessing Cycles for Handpieces when Cleaned with an Automatic Washer

Permitted Number of Reprocessing Cycles for Handpieces

when Cleaned with an Automatic Washer
The following table lists the maximum permitted number of times each
handpiece can be cleaned and sterilized when using an Automatic
Washer.

Handpiece Cycles

C2602, 36kHz 100 cycles or 50 hours of use, whichever comes first

Straight

C2600, 23kHz 70 cycles or 50 hours of use, whichever comes first

Straight

C2601, 23kHz 30 cycles or 50 hours of use, whichever comes first

Angled

Cleaning the Tip Torquing Set

Notice
Product damage will result if you do not follow these notices when cleaning the
Tip Torquing Set:.
• Do not use ultrasonic or automated 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

1. Using a soft cloth and mild cleansing solution or blood dissolving

detergent, manually clean the tip torquing base and the torque wrench.
2. Rinse the tip torquing base and torque wrench thoroughly with clean,
running water.
3. Using a soft cloth, dry the tip torquing base and torque wrench.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 13-7
Notes

13-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 14
14 Troubleshooting the System

In this section:

• For Your Information, page 14-1

• Responding to Alarms, page 14-2
• General Troubleshooting, page 14-5

For Your Information

This chapter describes troubleshooting procedures for the
CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System. It
describes how to resolve an alarm on the system, and also general
troubleshooting procedures
Note: To prevent tip blockage during surgery, try this. After using the tip, if
you intend to set it aside for a while before using it again, flush it with
saline solution. This removes debris before it can dry and block the tip
while it is not in use.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-1
Responding to Alarms

Responding to Alarms

Alarm Cause Recommended Actions

Footswitch Footswitch cable not properly Connect the footswitch to the console (rear panel).
connected to console Turn the connector until you feel it lock into place.
If the alarm persists after you connect the footswitch
to the console, call Integra for assistance.

Handpiece Handpiece cable not properly Connect the handpiece to the console. Twist the
connected to console handpiece connector clockwise until it locks into
place, then verify that the yellow dots align.
If the alarm persists after you connect the handpiece
to the console, call Integra for assistance.

Cooling Water Not enough distilled water in the Add distilled water to the cooling water reservoir up
cooling water reservoir to the fill line.

Cooling water reservoir not properly Re-seat the cooling water reservoir in the console.
seated

A pinch or kink in the handpiece cable Remove the pinch or kink in the cable.

Handpiece cable not properly Connect the handpiece to the console. Twist the
connected to console handpiece connector clockwise until it locks into
place, then verify that the yellow dots align.

Damaged, misaligned, or missing Connect a new sterilized handpiece to the system,

o-rings in the handpiece connector and test it for proper function.
If the alarm persists after you connect the new
handpiece to the console, call Integra for assistance.

Cooling Water–On Possible air bubble in the handpiece The CUSA Excel/CUSA Excel+ System corrects this
Intermittently cooling system condition. However, if the Cooling Water alarm
remains lit, refer to the condition immediately before
this one: Cooling Water – continuously on.
Note: If the Cooling Water alarm persists (it
continues to illuminate intermittently), call Integra for
assistance.

A pinch or kink in the handpiece cable Remove the pinch or kink in the cable.

14-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Responding to Alarms

Alarm Cause Recommended Actions

Vibration–In Test Tip loose due to incorrect assembly Testing before sterilization:
mode only
1. Use the tip torquing base and wrench to tighten
the tip.
2. Test the tip by testing the handpiece. See Testing
the Handpiece, page 5-11.
3. Sterilize the handpiece.

Testing after sterilization when tip assembled in a

nonsterile area:
1. Remove the handpiece from the sterile field.
2. Use the tip torquing base and wrench to tighten
the tip.
3. Test the tip by testing the handpiece. See Testing
the Handpiece, page 5-11.
4. Sterilize the handpiece.

Testing after sterile tip assembled to handpiece in

the sterile field:
1. Use the sterile torque base and a disposable
sterile wrench to tighten the tip. (See Section 11:
Assembling or Changing Tips in the Sterile Field)
2. Test the tip by testing the handpiece. See Testing
the Handpiece, page 5-11.

Tip contacting another object Remove the contact with any other object.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-3
Responding to Alarms

Alarm Cause Recommended Actions

Vibration–In Test Blocked tip 1. Verify that the manifold suction tube connects
mode only 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, then reconnect the
tubing to the nosecone.
5. Immerse the handpiece tip in sterile irrigation
fluid briefly. This may clear the suction tubing.

Damaged or cracked tip Testing before sterilization:

1. Use the tip torquing base and wrench to replace
the tip.
2. Test the tip by testing the handpiece. See Testing
the Handpiece, page 5-11.
3. Sterilize the handpiece.

Testing after sterilization when tip assembled in a

nonsterile area:
1. Remove the handpiece from the sterile field.
2. Use the tip torquing base and wrench to replace
the tip.
3. Test the tip by testing the handpiece. See Testing
the Handpiece, page 5-11.
4. Sterilize the handpiece.

Testing after sterile tip assembled to handpiece in

the sterile field:
1. Use the sterile torque base and a disposable
sterile wrench to replace the tip. (See Section 11:
Assembling or Changing Tips in the Sterile Field)
2. Test the tip by testing the handpiece.

14-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Alarm Cause Recommended Actions

Vibration–In Test Damaged handpiece 1. Connect a new sterilized handpiece to the

mode only CUSA Excel/CUSA Excel+ System 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

Condition Causes Recommended Action

No power at the console AC Main Switch (on the rear Turn on the AC Main Switch (on the
panel) off rear panel).

System Power Switch (front of Turn on the System Power Switch (on
console) off the front of the console).

Power cord not plugged in Plug the power cord into the wall
receptacle.

Wall receptacle has no power Try another wall receptacle, or check

available the operating room circuit breakers.

Fuse blown in plug Change the fuse in the plug. This

procedure should be performed by
the hospital technician.

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 status indicator
(flashing) turns off, press the
Prime button to make sure the
irrigation system is ready to use.
5. Adjust the Aspiration, Irrigation,
Amplitude, and Tissue Select®
settings.
6. Push the Status button to change
to Run mode.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-5
General Troubleshooting

Condition Causes Recommended Action

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 status indicator
(flashing) turns off, press the
Prime button to make sure the
irrigation system is ready to use.
4. Adjust the Aspiration, Irrigation,
Amplitude, and Tissue Select
settings.
5. Push the Status button to change
to Run mode.

No irrigation flow from the IV administration set roller clamp Open the roller clamp.
handpiece flue; the handpiece tip closed
gets hot
Irrigation tubing not routed properly Route the irrigation tubing properly
through irrigation pump through the irrigation pump.

Manifold irrigation tubing not Connect the Luer fitting.

connected to the handpiece flue
tubing

Not enough time set at Prime to allow Press the Prime button, and wait until
fluid to pass through the irrigation irrigation fluid drips from the tip.
tubing

Irrigation tubing pinched or kinked Remove the pinch or kink from the
tubing.

IV bag empty Replace the IV bag.

Note: For long periods of nonuse,

switch the CUSA Excel/CUSA Excel+
System console to Standby mode to
conserve irrigation solution.

Irrigation pump not turning Call Integra for assistance.

14-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Condition Causes Recommended Action

Excessive misting at the Flue not lined up with tip Adjust the flue position to line up with
handpiece tip pre-aspiration holes the pre-aspiration holes in the tip. See
Attach the Tip and O-rings, page 11-5.

Too much irrigation Reduce the irrigation rate.

Low suction setting on the control Increase the setting.

panel

Low or no suction due to suction Verify that the manifold suction tube
tubing improperly connected to connects properly to the nosecone by
handpiece disconnecting, then reconnecting, the
tubing and its clip.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-7
General Troubleshooting

Condition Causes Recommended Action

Excessive misting at the Blocked tip 1. Verify that the manifold suction
handpiece tube connects properly to the
tip–continued 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

handpiece sterile 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 1. Examine the suction tubing along

between the handpiece and the its entire length for a blockage.
suction canister
2. Squeeze the blocked area to
loosen it.
3. Immerse the handpiece tip in
sterile irrigation fluid briefly. This
may clear the blockage.

Suction canister full Replace the suction canister.

14-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Condition Causes Recommended Action

Excessive misting at the Suction connections at the suction 1. Remove any unused suction
handpiece canister not seated properly canister “elbow” connectors.
tip–continued
2. Reseat all connections.

Open port(s) on the suction canister Close any open ports on the suction
canister.

Suction canister improperly Refer to the canister manufacturer’s

connected instructions for connecting the
canister.

Inside of the contamination guard wet 1. Disconnect the contamination

and blocked guard 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.

Problem at the Remove the contamination guard and

CUSA Excel/CUSA Excel+ System put a finger in the suction system port.
console suction port If you feel no suction, call Integra for
assistance.

Suction pinch valve not working Check the Lap mode indicator.
properly
• 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 Run mode status indicator System in Standby mode Press the Status button to switch the
does not illuminate when you system to Run mode.
activate vibration.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-9
General Troubleshooting

Condition Causes Recommended Action

Little or no vibration or Excessive tip/tissue pressure (stalling 1. Verify that console settings are at
fragmentation (Amplitude setpoint tip) desired levels.
indicators may illuminate well
2. Remove the tip from contact with
below setpoint)
tissue, then reactivate vibration.
Note: When first activating
vibration, make sure that there is
no tip/tissue pressure.

Blocked tip 1. Verify that the manifold suction

tube 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, then reconnect the tubing
to the nosecone.
5. Immerse the handpiece tip in
sterile irrigation fluid briefly. This
may clear the suction tubing.

Incorrect flue installed Install the correct flue.

14-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Condition Causes Recommended Action

Little or no vibration or Tip loose due to improper assembly 1. Press the Status button to place
fragmentation (Amplitude setpoint the system in Standby mode.
indicators may illuminate well
2. Press the Test button to test the
below setpoint)–continued
handpiece and tip.
3. If the Vibration alarm activates, do
one of the following:
If tip assembled in a nonsterile area:
• Remove the handpiece from the
sterile field.
• Use the tip torquing base and
wrench to tighten the tip.
• Test the tip by testing the
handpiece.
• Sterilize the handpiece.
If sterile tip assembled to handpiece
in the sterile field:
• Use the sterilizable torque base
and a disposable sterile wrench
to tighten the tip. (See Section
11: Assembling or Changing
Tips in the Sterile Field)Test the
tip by testing the handpiece.

Console not left in Run mode for a 1. Return to Standby mode.

minimum of two continuous minutes
2. Restart Run mode and wait for
(36 kHz handpiece only).
two minutes before using the
system.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-11
General Troubleshooting

Condition Causes Recommended Action

Little or no vibration or Damaged or cracked tip 1. Press the Status button to place
fragmentation (Amplitude setpoint the system in Standby mode.
indicators may illuminate well
2. Press the Test button to test the
below setpoint)–continued
handpiece and tip.
3. If the Vibration alarm activates, do
one of the following:
If tip assembled in a nonsterile area:
• Remove the handpiece from the
sterile field.
• Use the tip torquing base and
wrench to replace the tip.
• Test the tip by testing the
handpiece.
• Sterilize the handpiece.

If sterile tip assembled to handpiece

in the sterile field:
• Use the sterilizable torque base
and a disposable sterile wrench
to replace the tip. (See Section
11: Assembling or Changing
Tips in the Sterile Field)
• Test the tip by testing the
handpiece.

Damaged handpiece 1. Connect a new handpiece to the

CUSA Excel/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.

Suction tube won’t assemble Nosecone not assembled to Align the dot on the nosecone with
correctly to handpiece nosecone handpiece correctly the dot on the handpiece.

Transducer is twisted inside Replace with a sterilized handpiece.

handpiece housing

14-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Condition Causes Recommended Action

Low suction at the handpiece tip Low suction setting on the control Increase the setting.
panel

System inadvertently in Lap mode Turn off the Lap mode by pressing the
Lap mode button.

Suction tubing improperly connected Verify that the manifold suction tube
to handpiece connects properly to the nosecone by
disconnecting, then reconnecting, the
tubing and its clip.

Blocked tip 1. Verify that the manifold suction

tube 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 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

handpiece sterile 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.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-13
General Troubleshooting

Condition Causes Recommended Action

Low suction at the handpiece A blockage in the suction tubing 1. Examine the suction tubing along
tip–continued between the handpiece and the its entire length for a blockage.
suction canister
2. Squeeze the blocked area to
loosen it.
3. Immerse the handpiece tip in
sterile irrigation fluid briefly. This
may clear the blockage.

Suction canister full Replace the suction canister.

Suction connections at the suction 1. Remove any unused suction

canister not seated properly canister “elbow” connectors.
2. Reseat all connections.

Open port(s) on the suction canister Close any open ports on the suction
canister.

Suction canister improperly Refer to the canister manufacturer’s

connected instructions for connecting the
canister.

Inside of the contamination guard 1. Disconnect the contamination

wet, blocked, or both guard 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.

Problem at the console suction port Remove the contamination guard and
put a finger in the suction system port.
If you feel no suction, call Integra for
assistance.

Suction pinch valve working Check the Lap mode indicator.

improperly
• 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.

14-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 General Troubleshooting

Condition Causes Recommended Action

The handpiece gets hot Surgeon holding handpiece at tip and Hold the handpiece at the nosecone.
flue

Handpiece damage due to tip Replace with a sterilized handpiece.

torquing without the torque base

Loss of cooling water at the Check the Cooling Water System. If

handpiece problem persists, return handpiece for
service.

The nosecone is loose Large o-ring not installed correctly, or Install the large o-ring in the proper
missing position on the handpiece.

Nosecone worn Replace with a sterilized nosecone.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 14-15
Notes

14-16 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 SECTION 15
15 Maintaining the System

In this section:

• For Your Information, page 15-1

• Quick Reference, page 15-2
• Handpiece Maintenance, page 15-3
• Sterilizer Case Maintenance, page 15-4
• Handling and Transporting of the System, page 15-4
• Storage of the System and Accessories, page 15-5
• Disposal of the Equipment, page 15-5
• Return Equipment for Service, page 15-5
• Integra Service Centers, page 15-7

For Your Information

This chapter describes routine maintenance tasks for the system.
Biomedical Engineering at your facility should perform these tasks.
It also describes handling and storage information for the system, and
information on returning equipment to Integra for service.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 15-1
Quick Reference

Quick Reference
The following chart lists routine maintenance tasks, when you perform
each task, and the equipment on which you perform them.
Table 15-1
Routine maintenance tasks for
CUSA® Excel/CUSA® Excel+ When Equipment Task
System
Daily or when used CUSA Excel/CUSA Disinfect and wipe dry.
Excel+ console

Daily or when used Cooling Water Discard water from the reservoir.
Reservoir

Daily or when used Footswitch 1. Discard the footswitch cover (if

using).
2. Clean the footswitch.

Every 3 months, or Console Fill the cooling water reservoir with

every 12 to 15 a solution consisting of 100 ml of
procedures, 70% alcohol and 900 ml of water.
whichever comes first Connect the handpiece, then turn
on the system. Allow the system to
run a few cooling cycles to clean
the interior tubing. Turn off the
system. Discard the alcohol
solution, then fill the reservoir with
distilled water. Turn on the system,
and allow it to cycle the water to
remove the alcohol solution from
the tubing.

Every 6 months, or Console Replace the contamination guard.

when filter changes Write either the installation date or
color the expiration date on the guard.

Once a year Console – Cooling Contact an Integra service

Water Tubing representative to replace the
cooling water pump tubing.

Once a year Console – Control Contact an Integra service

Arm Gasket representative to replace the
control arm gasket.

After 50 hours of use, Handpiece Return handpiece for service.

or 100 surgical
procedures,
whichever comes first

Every month or 80 Handpiece Apply a high viscosity lubricant to

hours of use the handpiece connector o-rings.

Every 6 months or Handpiece Replace the handpiece connector

500 hours of use o-rings.

15-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Handpiece Maintenance

Handpiece Maintenance
Maintaining the handpiece involves lubricating the handpiece connector o-
rings or replacing the handpiece connector o-rings.

Permitted Number of Reprocessing Cycles for

Handpieces when Cleaned with an Automatic Washer
The following table lists the maximum permitted number of times each
handpiece can be cleaned and sterilized when using an Automatic
Washer.

Handpiece Cycles

C2602, 36kHz 100 cycles or 50 hours of use, whichever comes first

Straight

C2600, 23kHz 70 cycles or 50 hours of use, whichever comes first

Straight

C2601, 23kHz 30 cycles or 50 hours of use, whichever comes first

Angled

Recalibrate the Handpiece

It is recommended that you return the handpiece for service after 50 hours
of use, or 100 surgical procedures, whichever comes first.
It is recommended that you retain a spare handpiece in the sterile field.
Contact Integra to arrange returning the handpiece for service. (See
“Return Equipment for Service” on page 15-5.)

Lubricate the Handpiece Connector O-Rings

Keeping the o-rings lubricated prevents them from drying out and
cracking, which may cause handpiece cooling problems.
Frequency: Every month or every 80 hours of use, whichever comes first.
Items needed: A high viscosity lubricant such as silicone grease.
Items to be lubricated: The four o-rings on the handpiece connector water
prongs.

Replace the Handpiece Connector O-Rings

Regularly replacing the o-rings prevents excessive wear, which may result
in handpiece cooling problems.
Frequency: Every six months or 500 hours of use, whichever comes first.
Items needed: O-Ring maintenance kit, which includes o-rings, an
insertion tool, and instructions.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 15-3
Sterilizer Case Maintenance

Items to be replaced: The four o-rings on the handpiece connector water

prongs.
Figure 15-1 Replacing o-ring on
the handpiece connector water
prongs

Insertion Tool

Sterilizer Case Maintenance

Use a neutral detergent to clean the sterilizer case.

Notice
Do not clean the sterilizer case with abrasives. Product damage will result.

Handling and Transporting of the System

If you need to move/relocate the CUSA Excel/CUSA Excel+ System
within the environment of the Healthcare Facility, note the guidelines
below.
Before moving the console:
• Unplug the power cord from the wall receptacle and place the power
cord in the storage compartment at the rear of the console.
• Disconnect the handpiece.
• Disconnect and remove the irrigation fluid.
• Retract the IV pole.
• Secure any loose objects. Make sure there are no loose objects placed
on the top of the console.
• Secure the footswitch cord on cord wraps provided on the back of the
console and place the footswitch in the storage compartment at the
rear of the console.
• Adjust the control panel to its lowest height. Make sure the control
panel is locked into position.
When moving the console:
• Push the console using the handle; don’t pull it.

15-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Storage of the System and Accessories

• Do not run whilst pushing the console.

• Use a lift to move the console between floors of a building. Never use a
stairwell.
• Do not attempt to lift the console.
To move the console up or down a ramp, use two or more people.
The CUSA Excel/CUSA Excel+ System requires a minimum of one hour
exposure at its operating temperature range before you use it; make sure
that the system is located in the surgical room at least an hour before use.

Storage of the System and Accessories

Console
Drain all liquids. Make sure the system is clean. Store the 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 and 65°C.

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 and 65°C.

Footswitch
You do not need to disconnect the footswitch from the console except for
maintenance or service. When you are not using the
CUSA Excel/CUSA Excel+ System, secure the footswitch cord on cord
wraps provided on the back of the console and store the footswitch in the
storage compartment in the rear of the console.

Disposal of the Equipment

The CUSA Excel family of consoles, handpieces and footswitches are
considered electrical equipment and must be disposed of in accordance
with regional regulations hospital protocols.

Return Equipment for Service

Before you return CUSA Excel/CUSA Excel+ equipment, call your Integra
representative for help. If the representative tells you to send the
equipment to Integra, first obtain a Return Authorization Number. Then
clean the equipment and ship it to Integra for service.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 15-5
Return Equipment for Service

Obtaining a Return Authorization Number

Call the Integra Service Center for your area (refer to Integra Service
Centers in this section) to obtain a Return Authorization Number. Have the
following information ready when you call:
• Hospital/clinic name/customer number
• Technician’s name
• Telephone number
• Department/address, city, state, and zip or postal code
• Model number
• Serial number
• Description of the problem
• Type of repair to be done (if known)
Attach a tag with this same information to the equipment when you ship it
for service.

Returning the Console

Notice
To avoid product damage, use proper packaging materials and packing
procedures when preparing the console for shipment. Failure to return product
in this manner may void your warranty.

For instructions on packing the console properly, contact your Integra

representative.

Returning Handpieces
Clean, disinfect, and sterilize a handpiece before you package it for
shipping.
Package a handpiece to protect the handpiece and handpiece cable
connector from damage.
Package each handpiece in a separate packaging container.

Ordering Replacement Parts

The following replacement parts may be ordered from Integra:
• Cooling Water Reservoir (S202750115)
• O-Ring Maintenance Kit (S200700120)
When ordering replacement parts for equipment, include this information:
• Model number (located on the CUSA Excel/CUSA Excel+ System rear
panel)
• Serial number (located on the CUSA Excel/CUSA Excel+ System rear
panel)

15-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Integra Service Centers

Integra Service Centers

US Service Center
Integra Neurosciences
5965 Pacific Center Blvd,
Suite 702
San Diego, CA 92121
Tel: 858-455-1115 (X207 or X215)
Fax: 858-455-8298
E-mail: [email protected]

Europe, Middle East and Africa Service Center

Integra Neurosciences GmbH
Halskestrasse 25
Ratingen 40880
Germany
Tel: +49 2102 5535 6150
Fax: +49 2102 942 4872
E-mail: [email protected]

Asia Pacific Service Center

Integra NeuroSciences Pty. Ltd.
Unit 3, 24-30 Winterton Road,
CLAYTON, VIC. 3168, Australia
Tel: +613 85400400
Fax: +613 95400004
E-mail: [email protected]

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide 15-7
Notes

15-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 APPENDIX A

A Technical Specifications

Console Dimensions

CUSA® Excel/CUSA® Excel+ Console

Height 132 cm (52 in)

Width 55.88 cm (22 in)

Depth 71.12 cm (28 in)

Weight 93 kg (200 lbs)

Footswitch

Height 5.08 cm (2 in)

Width 30.48 cm (12 in)

Cable length 4.575 m (15 ft)

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-1
Console Subsystems

Console Subsystems

Ultrasonic

Frequency 23 kHz (nominal frequency)

(23kHz)

Frequency 35.67 - 35.83 kHz (frequency range)

(36kHz)

Maximum Tip Up to 355 microns for straight handpiece

Amplitude (23 kHz) Up to 183 microns for angled handpiece

Maximum Tip Up to 210 microns

Amplitude (36 kHz)

Fluidic System

Cooling System Cooling water flow is 35 – 50 ml/min.

Irrigation Rate The irrigation rate display shows digits 1 – 10

The irrigation rate is approximately
1 – 10 ml/min., normal; greater than 25 ml/min., Fast
Flush

Suction System Up to 660 mm (26 inches) mercury at the pump

intake at sea level
The suction level will be lower at higher altitudes.

A-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Electrical Requirements

Electrical Requirements

Input Power Source

Power Ratings The CUSA Excel/CUSA Excel+ System operates on

one of the following voltage ranges:
220–240 Volt
95–120 Volt
950–1200 VA (All 4 Models)
The voltage range is specified on the serial number
label on the console.
Line fusing resides in fuse receptacles on the rear
panel. The fuse values are:
• For 220–240 Volt operation: T5A.
• For 95–120 Volt operation: T10A.

Frequencies 50 Hz ± 2 Hz
60 Hz ± 2 Hz

Breaking Capacity T5A: Low

T10A: Low

Power Cords

Cord Harmonized type three conductor cord or UL listed

3-conductor.

Connector Integra provides a connector approved for the region

in which your country is geographically located. Refer
to the Plug IFU supplied in the console carton.

If a facility intends to use the CUSA Excel/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/CUSA Excel+ System in the
presence of flammable anesthetics or any potentially explosive or flammable
atmosphere.

Warning
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE
CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-3
Environment

Warning
The console must be earthed, and therefore it MUST only be fitted with a 3-pin
plug, or a 2-pin plug that has an integral earth grounding connection. Mains plug
type and construction MUST comply with Legal requirements within country of
installation. Only Integra Service personnel or Integra authorized
representatives or agents can change the mains plug on the console.

Low Frequency Leakage

Touch current <100µA

Patient leakage current <100µA

Duty Cycle
Under maximum loading conditions, the CUSA Excel/CUSA Excel+ console is
suitable for ultrasonics activation times of 10 minutes on, 5 minutes off.

Environment

Operating temperature 10°C (50°F) to 35°C (95°F)

range

Operating humidity 15 to 80%, relative humidity, non-condensing

range

Operating atmospheric 70 kPa to 106 kPa

pressure range

Storage and shipping -34°C (-29°F) to 65°C (149°F)

temperature

Storage and shipping 25 to 85% relative humidity, non-condensing

humidity

The system requires a minimum of one hour exposure at its operating temperature
range before you use it.
See section EMC Compatibility on page A-5 for further information on
environmental conditions.

Electromagnetic Interference
The CUSA Excel/CUSA Excel+ System console minimizes electromagnetic
interference to other equipment used in the operating room. The system complies
with the requirements of IEC 60601-1-2:2007.
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.

A-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Voluntary Standards

Voluntary Standards
The CUSA Excel/CUSA Excel+ System meets the following standards:
• IEC 60601-1:2005 Medical electrical equipment: General requirements for
basic safety and essential performance
• cUL/CSA Test requirements: (CSA 22.2, No. 601.1.8)
• IEC 60601-1-6:2005 Medical electrical equipment: General requirements for
basic safety and essential performance. Collateral Standard: Usability
• IEC 60601-1-2:2005 Medical electrical equipment: General requirements for
basic safety and essential performance. Collateral standard: Electromagnetic
compatibility - Requirements and tests
• CISPR11 Electromagnetic compatibility for industrial-process measurement
and control equipment: Emissions requirements
• ISTA Pre-Shipment Test Procedures

Statutory and Regulatory Classification

Class II (FDA) Medical Device (General Controls and Special Controls)
Class IIb (EU)
Class III (EU)
Class 4 (Canada)

EMC Compatibility
Notice
The CUSA Excel/CUSA Excel+ System should not be used adjacent to or
stacked with equipment other than the equipment specified in the
CUSA Excel/CUSA Excel+ System User Guide. If adjacent or stacked use is
necessary, the CUSA Excel/CUSA Excel+ System should be observed to verify
normal operation in the configuration in which it will be used.
The use of accessories, other than the accessories specified in the
CUSA Excel/CUSA Excel+ System User Guide may result in increased
emissions or decreased immunity of the CUSA Excel/CUSA Excel+ System.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-5
Voluntary Standards

Guidance and Manufacturer’s Declarations

Guidance and manufacturer’s declaration – electromagnetic emissions

The CUSA Excel/CUSA Excel+ System is intended for use in the electromagnetic environment specified below. The
customer or the user of the CUSA Excel/CUSA Excel+ System should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - Guidance

RF emissions Group 1 The CUSA Excel/CUSA Excel+ System uses RF energy

only for its internal function. Therefore, its RF emissions are
CISPR 11 very low and are not likely to cause any interference in
nearby electronic equipment.

RF emissions Class A The CUSA Excel/CUSA Excel+ System is suitable for use in
all establishments other than domestic and those directly
CISPR 11 connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonics emissions Class A

IEC 61000-3-2

Voltage fluctuations / flicker Complies

emissions

IEC 61000-3-3

A-6 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Voluntary Standards

Guidance and manufacturer’s declaration – electromagnetic immunity

The CUSA Excel/CUSA Excel+ System is intended for use in the electromagnetic environment specified below. The
customer or the user of the CUSA Excel/CUSA Excel+ System should assure that it is used in such an environment.

IMMUNITY Test IEC 60601 Compliance level Electromagnetic environment -

test level Guidance

Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or

(ESD) ceramic tile. If floors are covered with
± 8 kV air ± 8 kV air synthetic material, the relative humidity
IEC 61000-4-2 should be at least 30 %.

Electrical fast ± 2 kV for power supply ± 2 kV for power Mains power quality should be that of a
transient/burst lines supply lines typical commercial or hospital
environment.
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for input/output
lines lines

Surge ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that of a
typical commercial or hospital
IEC 61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth environment.

Voltage dips, short <5 % UT <5 % UT Mains power quality should be that of a
interruptions and (>95 % dip in UT) (>95 % dip in UT) typical commercial or hospital
voltage variations on for 0,5 cycle for 0,5 cycle environment. If the user of the CUSA
power supply input Excel/CUSA Excel+ System requires
lines. <40 % UT <40 % UT continued operation during power mains
(>60 % dip in UT) (>60 % dip in UT) interruptions, it is recommended that the
IEC 61000-4-11 for 5 cycles for 5 cycles CUSA Excel/CUSA Excel+ System be
powered from an uninterruptible power
<70 % UT <70 % UT supply or a battery.
(>30 % dip in UT) (>30 % dip in UT)
for 25 cycles for 25 cycles

<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s

Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should
Hz) magnetic field be at levels characteristic of a typical
location in a typical commercial or hospital
IEC 61000-4-8 environment.

NOTE UT is the a.c. mains voltage prior to application of the test level.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-7
Voluntary Standards

Guidance and manufacturer’s declaration – electromagnetic immunity

The CUSA Excel/CUSA Excel+ System is intended for use in the electromagnetic environment specified below. The
customer or the user of the CUSA Excel/CUSA Excel+ System should assure that it is used in such an environment.

IMMUNITY Test IEC 60601 Compliance level Electromagnetic environment -Guidance

test level

Portable and mobile RF communications

equipment should be used no closer to any part of
the CUSA Excel/CUSA Excel+ System, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms
3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Radiated RF 3 V/m

IEC 61000-4-3
3 V/m Where P is the maximum output power rating of the
80 MHz to 2,5 GHz
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency rangeb.

Interference may occur in the vicinity of equipment

marked with the following symbol:

A-8 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Voluntary Standards

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 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/CUSA Excel+ System
is used exceeds the applicable RF compliance level above, the CUSA Excel/CUSA Excel+ System should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orientating or relocating the CUSA Excel/CUSA Excel+ System.

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-9
Voluntary Standards

Recommended separation distances between

portable and mobile RF communications equipment and the CUSA Excel/CUSA Excel+ System

The CUSA Excel/CUSA Excel+ System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CUSA Excel/CUSA Excel+ System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the CUSA Excel/CUSA Excel+ System as recommended below, according to the
maximum output power of the communications equipment.

Rated maximum output power of Separation distance according to frequency of transmitter

transmitter m

W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

0.01 0.12 m 0.12 m 0.24 m

0.1 0.38 m 0.38 m 0.76 m

1 1.2 m 1.2 m 2.4 m

10 3.8 m 3.8 m 7.6 m

100 12 m 12 m 24 m

For transmitters rated at maximum output power not listed above, the recommended separation distance d in
metres (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 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

A-10 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Handpieces

Handpieces

Nominal Frequencies

23 kHz Straight 23 kHz

23 kHz Angled 23 kHz

36 kHz Straight 35.75 kHz

Dimensions

23 kHz Straight
Length 22.2 cm (8.74 in)

Diameter 2.08 cm (0.82 in)

23 kHz Angled
Length 22.2 cm (8.74 in)

Diameter 2.08 cm (0.82 in)

36 kHz Straight
Length 13.9 cm (5.47 in)

Diameter 1.64 cm (0.65 in)

Tip Specifications
Table A-1 on page A-12 shows specifications for tips that attach to the 23 kHz
handpiece.
Table A-2 on page A-13 shows specifications for tips that attach to the 36 kHz
handpiece.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-11
Tip Specifications

Tip Specifications for 23 kHz Handpiece

Table A-1
Tip Specifications—23 kHz

Tip Length ID OD Amplitude (peak to peak) Weight

(mm) [in] (mm) [in] (mm) [in] (µm) [in] (g)

Standard Tip 79.8 [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™ 92.2 [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 183.8[7.238] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 16.15

Extended 287 to 355 [0.0113 to 0.0140]
Standard Tip
Angled Handpiece:
112 to 163 [0.0044 to 0.0064]

Curved Extended 183.8 [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™ 79.5 [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 301.4 [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

Extended Life 79.8 [3.140] 1.98 [0.078] 2.54 [0.100] Straight Handpiece: 3.54
Standard Tipa 287 to 355 [0.0113 to 0.0140]
Angled Handpiece:
112 to 163 [0.0044 to 0.0064]

Extended Life 79.5 [3.130] 2.64 [0.104] 3.18 [0.125] Straight Handpiece: 3.84
MacroTipb 254 to 307 [0.0100 to 0.0121]
Angled Handpiece:
102 to 142 [0.0040 to 0.0056]

a. Not for sale within USA.

b. Not for sale within USA.

A-12 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 Tip Specifications

Tip Specifications for the 36 kHz Handpiece

Table A-2
Tip Specifications—36 kHz

Length ID OD Amplitude (peak to peak) Weight

Tip (mm) [in] (mm) [in] (mm) [in] (µm) [in] (g)

PrecisionTip™ 56.4 [2.221] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 1.37

Straight Extended 125.1 [4.924] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 7.86
PrecisionTip

Curved Extended 125.1 [4.924] 1.14 [0.045] 1.45 [0.057] 191 to 210 [0.0075 to 0.0083] 7.86
PrecisionTip

MicroTip™ 52.8 [2.080] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 1.30

Straight Extended 121.5 [4.783] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 7.50
MicroTip

Curved Extended 121.5 [4.783] 1.57 [0.062] 1.93 [0.076] 175 to 193 [0.0069 to 0.0076] 7.50
MicroTip

Extended 192.7 [7.588] 1.57 [0.062] 1.93 [0.076] 137 to 155 [0.0054 to 0.0061] 7.97
MicroTip Plus

Standard Tip 45.7 [1.800] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 1.31

Straight Extended 114.4 [4.504] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 7.48
Standard Tip

Curved Extended 114.4 [4.504] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 7.48
Standard Tip

CUSA® 114.9 [4.525] 1.14 [0.45] 2.23 [0.088] 117 to 135 [0.0046 to 0.0053] 9.55
SaberTip™

CUSA® 117.9 [4.643] 1.57 [0.062] 2.33 [0.0919] 165 to 203 [0.0065 to 0.0080] 7.77
ShearTip™

Extended Life 125.1 [4.924] 1.14 [0.45] 1.45 [0.057] 175 to 210 [0.0069 to 0.0083] 7.86
Curved Extended
PrecisionTipa

Extended Life 121.5 [4.783] 1.57 [0.062] 1.93 [0.076] 165 to 193 [0.0065 to 0.0076] 7.50
Curved Extended
MicroTipb

Extended Life 114.4 [4.504] 1.98 [0.078] 2.54 [0.100] 137 to 155 [0.0054 to 0.0061] 7.48
Curved Extended
Standard Tipc

a. Not for sale within USA.

b. Not for sale within USA.
c. Not for sale within USA.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide A-13
Notes

A-14 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 APPENDIX B

B Sterilization Validation

Validation of Steam Sterilization Parameters

A steam sterilization study was conducted according to AAMI TIR No. 12-2010–
Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in
Health Care Facilities: A Guide for Device Manufacturers.

Challenge
A minimum of 1 x 106 bacillus stearothermophilus on a spore strip/disk carrier and
a braided nylon suture carrier. (D121°C = 1.5 and 1.6 minutes).

Placement of Biological Indicators (BIs)

CUSA 23 kHz Handpiece, Tip and Tubing:
Cycles contained four BIs (spore suture) placed in the following locations:
• Inside the tip, not assembled to the hand piece
• Wrapped around the handpiece cord
• Underneath the tip torquing base where it meets the bottom of the case
• Approximately half way inside the manifold tubing

CUSA 36 kHz Handpiece, Tip and Tubing:

Cycles contained four BIs (spore suture) placed in the following locations:
• Inside the tip when assembled to the handpiece
• Wrapped around the handpiece cord
• Underneath the tip torquing base where it meets the bottom of the case
• Approximately half way inside the manifold tubing

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide B-1
Validation of Steam Sterilization Parameters

Acceptance Criteria
In order for the handpiece to be considered validated, none of the biological
indicators demonstrated growth of the indicator organism. A 6-log reduction at the
half cycle exposure time indicates that a full cycle (twice the half cycle exposure
time) will produce sufficient lethality to effect at least a 12-log reduction and
provide a 10-6 sterility assurance level (SAL).

B-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 APPENDIX C

C Warranty
Integra Warranty for CUSA® Excel and CUSA® Excel+ Ultrasonic Surgical
Aspirator Systems

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 and 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 and CUSA Excel+ Ultrasonic Surgical Aspirator Operator’s
Manuals, as such Operator’s Manuals 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;

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide C-1
 (v) defects resulting from repairs or service of the Equipment provided
other than by Integra or its authorized representatives;
(vi) defects arising from accidental damage to the Equipment, acts of God,
electrical power damage, equipment malfunction, unusual stress,
unreasonable operating procedures or abnormal or extreme operating
conditions; and
(vii) normal wear and tear.

2. Service, Repairs and Replacement.

2.1. Service and Repairs. All service and repairs covered by this Warranty
may be referred to hereinafter as "in-warranty repairs," and all service and
repairs not covered by this Warranty may be referred to as "out-of-warranty
repairs." Integra's sole obligation for in-warranty repairs shall be to make all
necessary adjustments and repairs in accordance with this Warranty. Integra
shall charge Customer at Integra standard rates for any out-of-warranty repair
performed by Integra.
2.2. Equipment Replacement. The defective Equipment or part thereof that is
replaced in accordance with the Warranty shall be the property of Integra.
Integra reserves the right to fill spare parts requests using refurbished sub-
assemblies provided that such sub-assemblies are functionally equivalent to
new sub-assemblies and carry the same warranty as the replaced sub-
assemblies.
2.3. Notification. In order to avail itself of its rights under the Warranty,
Customer or Integra authorized distributors, must immediately notify Integra of
any defects and provide Integra every opportunity to inspect and remedy
defects.

3. Repair Parts and Services.

3.1. Included under the Warranty are the following services:
3.1.1. Consoles. Integra or its distributor, when authorized for this purpose,
shall, if possible, perform on-site repair of consoles and where not possible
or otherwise decided at the sole discretion of Integra, Integra or its
distributor shall arrange and pay to ship the affected Equipment to the
designated repair facility. Integra or its distributor authorized for this
purpose shall repair the affected Equipment or replace a console by a new
or refurbished console (all of which at the discretion of Integra), that shall
carry the same remaining warranty as the original equipment.
3.1.2. Handpieces. Integra shall repair or replace any defective handpieces
covered by the Warranty by a new or refurbished handpiece (all of which at
the discretion of Integra) that shall carry the same remaining warranty as
the original equipment (an "Exchange Handpiece").
3.2. Modifications to Covered Equipment. From time to time, at its sole
discretion, Integra may propose modifications to the covered Equipment and to
the Specifications for the Equipment. Subject to Customer's approval and at
its sole expense, the Customer may request Integra to make such
modifications to the covered Equipment and to the Specifications. Integra shall
make such modifications for the Customer, which modifications may include
the installation of new parts in the Equipment, at a price equal to the then-
current list price for such modifications, as such list price is established by
Integra in its sole discretion.

C-2 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide
 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.

5. Limitation of Liability.
5.1. INTEGRA's sole responsibility under the warranties described in Section 1
shall be repair or replacement, at INTEGRA's sole discretion at INTEGRA's
expense, subject to the terms of this warranty and applicable agreements. THE
WARRANTIES DESCRIBED IN SECTION 1 HEREOF ARE EXCLUSIVE AND
ARE GIVEN AND ACCEPTED IN LIEU OF ALL OTHER WARRANTIES OF
INTEGRA OR ITS 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,

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide C-3
 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. THIS INTEGRA
DISTRIBUTOR LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL
OTHER WARRANTIES TOWARDS CUSTOMER, EXPRESS OR IMPLIED,
AND OF ALL OTHER OBLIGATIONS OR LIABILITIES TOWARDS
CUSTOMER ON INTEGRA AUTHORIZED DISTRIBUTOR'S PART.
INTEGRA AUTHORISED DISTRIBUTORS DISCLAIM ALL OTHER
WARRANTIES TOWARDS CUSTOMER, 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 OR OTHER THIRD PARTIES.
5.5 Force Majeure. Notwithstanding anything to the contrary herein
contained, if the performance of the Warranty by Integra, Integra authorized
distributors, or Customer or any obligation of Integra, Integra authorized
distributors, or Customer hereunder is prevented, restricted or interfered with
by reason of fire, explosion, act of God, labor disputes or accidents affecting
performance under the Warranty, or war, mobilization, civil commotions,
blockade or embargo, or any future law, regulation, ordinance or requirement
of any government or regulatory agency or any other act, whatsoever similar to
those above enumerated, or any other circumstance being beyond the
reasonable control of Integra, Integra authorized distributors, or Customer,
then and in that event Integra, Integra authorized distributors, or Customer, as
the case may be, shall promptly notify the other party hereto of the difficulties
resulting therefrom, and any of the foregoing events shall excuse any
performance required under the Warranty.

C-4 CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide