Integra® CUSA® NXT: Ultrasonic Surgical Aspirator System

Integra®
CUSA® NXT Operator’s Manual
Integra® CUSA® NXT OPERATOR’S MANUAL
Ultrasonic Surgical Aspirator System
Integra® CUSA® NXT Operator’s Manual

Integra LifeSciences (Ireland) Limited
IDA Business and Technology Park
Sragh
Tullamore, County Offaly, Ireland
For more information or to place an order, please contact:

Integra 311 Enterprise Drive, Plainsboro, NJ 08536
n
USA and Canada: 800.997.4868 609.936.5400 (Outside USA)

n
888.980.7742 (Fax)
integralife.com
0877085 -1
72904051, Issue E
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
Publication Name:
CUSA® NXT Operator’s Manual
Integra Part Number: 72904051 Rev. E
Effective Date: January 2018
Trademark Acknowledgements:
Integra, the Integra logo, CUSA and Selector are registered trademarks of
Integra LifeSciences Corporation or its subsidiaries in the United States
and/or other countries. SaberTip and MicroTip are trademarks of Integra
LifeSciences Corporation or its subsidiaries. Bemis and Hi-Flow are
trademarks of Bemis Manufacturing Company. Cidex and Nu-Cidex are
trademarks of Johnson & Johnson. Hibicet and Hibitane are trademarks of
Regent Medical Limited. RECEPTAL is a trademark of Hospira, Inc.
Copyright Information:
0086 © 2018 Integra LifeSciences Corporation. All Rights Reserved.

No part of this document may be reproduced, stored in a retrieval system,
or transmitted, in any form or by any means - electronic, mechanical,
photocopying, recording, or otherwise - without the expressed, written
consent of Integra LifeSciences. Additional copies of this document can be
ordered from Integra LifeSciences.
Integra LifeSciences (Ireland) Limited.

IDA Business & Technology Park
Sragh
Tullamore
County Offaly
Ireland
www.integralife.com
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TABLE OF CONTENTS
Chapter 1: Patient and Operating Room Safety

System Overview ....................................................................................................................................1
Intended Use ..................................................................................................................................1
Contraindications ............................................................................................................................1
Intended Users ........................................................................................................................................2
Warnings, Cautions and Notices .............................................................................................................3
Patient and Operating Room Safety ...............................................................................................3
CUSA NXT System Setup and Components..................................................................................3
Using the Console, Service Module, and Handpieces ...................................................................5
Preparing the CUSA NXT System for Surgery ...............................................................................6
Operating the CUSA NXT System During Surgery ........................................................................8
Disassembly and Sterilization of CUSA NXT System ....................................................................8
Use of System in MRI Environments ..............................................................................................9
Troubleshooting the CUSA NXT System......................................................................................10
Technical Specifications ...............................................................................................................10
Classification and System Symbols ......................................................................................................10
Tubing Pathway Symbols .............................................................................................................14
Footswitch Symbols......................................................................................................................16
Chapter 2: CUSA® NXT System Setup and Components

Unpacking and Installing the System ....................................................................................................17
Commissioning the System ..........................................................................................................18
Initial Setup of Console with the Service Module .........................................................................19
List of CUSA NXT Components ............................................................................................................20
About the Console ........................................................................................................................20
About the Footswitch ....................................................................................................................21
About the Service Module ............................................................................................................21
About the Handpieces and Wrench Sets ..............................................................................................23
Handpieces...................................................................................................................................23
Wrench Sets .................................................................................................................................23
About the Tubing Kits ............................................................................................................................24
About the Sterile and Non-Sterile Tips ..................................................................................................25
For Neuro Handpieces .................................................................................................................25
For Standard Handpieces.............................................................................................................26
Summary of Operating Safety Precautions ...........................................................................................27
i
Using the Handpieces.................................................................................................................. 27
Sterilizing Backup Handpieces .................................................................................................... 28
Warnings and Hazards when Using the System.......................................................................... 28
Requirements for Servicing the System....................................................................................... 31
Explosion and Fire Hazards......................................................................................................... 31
Latex Information ......................................................................................................................... 31
Chapter 3: Using the Console, Service Module, and Handpieces

About the Console Functionality ........................................................................................................... 33
About the Left Console Panel ...................................................................................................... 34
About the Rear Console Panel .................................................................................................... 35
Connecting Handpieces to the Console....................................................................................... 36
Using the Footswitch Pedals ................................................................................................................ 36
Using the Touch Screen Monitor .......................................................................................................... 38
Status/Alarm Symbols.................................................................................................................. 39
Adjusting the Ultrasonic Control Scales....................................................................................... 41
Verifying General Ultrasonic Information ..................................................................................... 43
Displaying Menus for Prime Mode, Customized Settings, and Online Help ................................ 44
About the Service Module Functionality ............................................................................................... 44
About the Handpiece Functionality....................................................................................................... 47
List of Handpieces ................................................................................................................................ 47
List of Standard Handpieces........................................................................................................ 48
List of Neurosurgical Handpieces ................................................................................................ 50
List of MicroSurgical Handpieces................................................................................................. 54
Chapter 4: Preparing the CUSA® NXT System for Surgery

List of Requirements............................................................................................................................. 55
Assembling the Handpieces ................................................................................................................. 56
Preparing the System ........................................................................................................................... 59
Prepare the Suction Source......................................................................................................... 59
Prepare the IV Bag ...................................................................................................................... 60
Prepare the Tubing Kits ............................................................................................................... 60
Connect Tubing to Console ......................................................................................................... 62
Position the Footswitch ................................................................................................................ 63
Priming the Handpieces ....................................................................................................................... 63
Testing the Alarm Tone ........................................................................................................................ 65
Chapter 5: Operating the CUSA® NXT System During Surgery

Operating the System During Surgery.................................................................................................. 67
ii
Warnings Relating to the Tips During Surgery ......................................................................................69
Customizing the User Settings ..............................................................................................................70
Chapter 6: Disassembly and Sterilization of CUSA® NXT System

Dismantling the System After Surgery ..................................................................................................73
Cleaning the Handpieces After Surgery ................................................................................................75
Disassembling the Handpieces ....................................................................................................75
Sterilizing Components and Maintaining the Handpieces .....................................................................77
Recommended Sterilization Procedures ......................................................................................77
Disinfecting the Handpieces .........................................................................................................78
Maintaining the Handpieces .........................................................................................................79
Maintaining the Touch Screen Monitor .................................................................................................80
Safety Guidelines .........................................................................................................................80
Cleaning Guidelines .....................................................................................................................80
Handling and Transporting the System .................................................................................................81
Console with Service Module .......................................................................................................81
Console without Service Module ..................................................................................................81
Shipping Instructions ....................................................................................................................82
Chapter 7: Troubleshooting the CUSA® NXT System

About the Troubleshooting Process ......................................................................................................83
Problems Powering the System On and Off .........................................................................................83
Responding to Alarms ...........................................................................................................................84
Troubleshooting Aspiration Problems ...................................................................................................85
Troubleshooting Irrigation Problems .....................................................................................................86
Troubleshooting Ultrasonic Power Problems ........................................................................................87
Appendix A: Technical Specifications

Specifications for the CUSA® NXT System...........................................................................................89
Electrical Safety ....................................................................................................................................91
Standards and IEC Classifications ........................................................................................................93
Manufacturer’s Declaration Table .........................................................................................................94
Appendix B: Warranty
Integra Warranty for the CUSA® NXT Ultrasonic Surgical Aspirator.....................................................99
Index .............................................................................................................................. 103
iii
iv
CHAPTER 1 PATIENT AND OPERATING ROOM SAFETY
System Overview ............................................................................................. 1

Intended Users................................................................................................. 2
Warnings, Cautions and Notices.................................................................... 3
Classification and System Symbols ............................................................ 10
System Overview
The CUSA® NXT Ultrasonic Surgical Aspirator System facilitates the removal
of tissue. The system provides selective tissue disintegration with
simultaneous irrigation and aspiration.
Intended Use
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in
surgical procedures where fragmentation, emulsification and aspiration of
soft and hard (e.g. bone) tissue is desirable, including Neurosurgery,
Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and
Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological
surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Using this System in Ultrasonic Surgery

The basic operating principle of ultrasonic surgery involves the longitudinal
vibration of the hollow handpiece tip at ultrasonic frequency against tissue.
The mechanical action of the tip is similar to a tiny “surgical hammer” that
breaks off cellular material. When the tip contacts the fluid filled tissue, the
resulting slurry of emulsified material from the tissue is aspirated through the
center of the handpiece. A slow flow of irrigant around the tip assists in the
removal of waste tissue.
The selective action of the instrument arises from the disruption of fluid
containing cellular material while fibrous and elastic tissue such as nerves
and blood vessels remain relatively unaffected at the ultrasonic frequencies
used.
Warning
No modification of this equipment is allowed.
Contraindications
This device is not indicated for and should not be used for the removal of
uterine fibroids.
Chapter 1 • Patient and Operating Room Safety • 1

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 NXT System should only be used in a surgical environment by
qualified medical professionals.
Warning
The Console is only to be used in a hospital environment and by qualified
operators and surgeons. Failure to observe this warning could result in serious
injury or death.
It is the responsibility of the Healthcare Facility to ensure that intended users of
CUSA NXT System are appropriately trained in the use of this equipment.
Reviewing the Operator’s Manual

Verify that all surgeons, nurses, and technicians who will be setting up,
operating and maintaining the CUSA NXT System review this Operator’s
Manual prior to using the system in a surgical procedure. Pay close attention
to the operating safety warning, cautions and notices listed in the section
Warnings, Cautions and Notices, p. 3. If there are additional questions after
reading this manual, contact the technical support staff at Integra
LifeSciences.
To draw immediate attention to matters of importance, this guide presents
warnings, cautions and notices as follows:
Warning
Indicates a potentially hazardous situation that, if not avoided, could result in
serious injury or death, or product damage.
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.
Online Help
On the touch screen monitor, press the help button to display the online help
system. Please note that the online help system only provides basic
guidelines for performing common CUSA NXT tasks. The online help does
not:
• Replace this Operator’s Manual.
• Provide clinical instructions for any specific procedures.
2 • Chapter 1 • Patient and Operating Room Safety

For complete instructions on using the CUSA NXT System, refer to the
procedures described in this Operator’s Manual.
Warnings, Cautions and Notices

To promote the safe use of the CUSA NXT System, this section presents the
warnings, cautions, and notices that appear throughout this guide.To operate
this equipment with maximum safety, it is important that you read, understand
and follow the instructions in the warnings, cautions, and notices.
Patient and Operating Room Safety
Warning
The Console is only to be used in a hospital environment and by qualified

operators and surgeons. Failure to observe this warning could result in serious
injury or death.
It is the responsibility of the Healthcare Facility to ensure that intended users of
CUSA NXT System are appropriately trained in the use of this equipment.
CUSA NXT System Setup and Components
Warning
Only operate the footswitch when the base of the footswitch is positioned flat on
the ground, and the front of the footswitch is facing upwards with the pedals
visible and free from obstruction.
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE

CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH.
Only use Integra handpieces and accessories with the CUSA NXT System. The
use of non-Integra handpieces or accessories may result in patient injury.
Non-Integra handpieces or accessories are not supported and are not covered
by warranty.
When you connect the handpiece to the Console, the handpiece becomes a
functional surgical device.
When the handpiece is connected to a CUSA NXT 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, non-conductive, and highly visible
surface.

Warning
When pressing the Power Footswitch pedal to operate the handpiece, do not
allow the tip of the handpiece to come into contact with any object except for the
target tissue at the operating site. Touching the tip while powered can result in
personal injury.
The handpiece and handpiece accessories must be sterile before surgical use.
Risk of explosion. Do not use in the presence of flammable anaesthetic gases

or other volatile solvents.
• Electrical shock hazard. Do not remove cover.

• Refer servicing to authorized service personnel.
To avoid personal injury or damage to the tip, do not allow the tip of the
handpiece to contact any operator or hard surfaces or anything other than the
target tissue when powered.
For continued protection against fire and electrical hazard, replace fuse only
with same type and rating.
Do not use a damaged handpiece with the CUSA NXT System.This may result
in injury to the patient or surgical personnel. A damaged handpiece must be
returned to the manufacturer for repair. Do not attempt to dismantle the rear
handle sections of the handpieces; it does not contain any serviceable parts.
Use of the handpiece outside of the specified conditions can result in high
operating temperatures.
Contact between the unprotected part of the tip and non-target tissue can result
in burns.
Use of the handpieces in a damaged condition can result in an electric shock

hazard.
Failure to maintain the CUSA NXT System in accordance with the instructions
in this manual can compromise safety.
Use the single use CUSA® Selector® tubing, and single use tips and flue sets
once only. Re-use may result in a biological hazard.
Use single use tips for a single procedure only. Re-using single use tips may
result in tip fragmentation and injure the patient or user.
Caution
If the packaging for a sterile accessory is damaged, do not use the sterile
accessory.
Contact of the moving tip against a hard surface, e.g. a metal instrument tray,
may damage the tip of the handpiece and require replacing the tip before use.
Do not use a handpiece with a broken tip.

Caution
Only use the CUSA Selector wrench kit to tighten tips and extensions on the
transducer of the handpiece. Always secure the handle of the handpiece in the
holder provided. Never dismantle or assemble the handpiece without placing
the handle section of the handpiece in the holder. Failure to comply with this
instruction could result in permanent damage to the transducer and will
invalidate the warranty.
Do not attempt to clear a blocked handpiece by passing the stylet down the rear
inlet of the handpiece. This may result in damage to the handpiece. Always
pass the stylet from the tip end.
Do not use a handpiece with a broken tip. Inspect the tip for damage prior to
use. If the tip is damaged it may be replaced by the operator.
Do not use dry air sterilization methods involving temperatures in excess of

139 °C (282 °F); this may damage the handpiece.
Do not power up the CUSA Selector handpiece without fully priming the
handpiece with irrigant (i.e. irrigant must flow from the tip of the handpiece).
Failure to prime the handpiece could result in permanent damage to the
handpiece (internal and/or external components) and may induce heat
exchange with the patient or user, and cause tissue burns.
Notice
In the event that you need to return a device to Integra, to prevent any damage,
use the appropriate packaging material.
To prevent fluid flowing into the vacuum line, only use a canister that has a non
return valve.
Using the Console, Service Module, and Handpieces
Warning
Ignoring alarms on the CUSA NXT System while continuing to use the system
may result in injury to the patient and/or surgical personnel, or equipment
damage.
The minimum aspiration level setting is 15%. This ensures proper handpiece
cooling and performance. Insufficient aspiration can cause premature
handpiece or tip failures and may induce heat exchange with the patient or user,
and cause tissue burns.

Caution
Pressing and releasing the Power pedal too quickly may result in a Handpiece
Tip Initialization failure. If this occurs, disconnect the handpiece, verify proper
tip assembly, and then reconnect the handpiece and try again.
Do not store anything in the storage area in the back of the Console while the
system is running.
Notice
After releasing the Power pedal, the pinch valve operates momentarily to block
aspiration and facilitate tissue release from the handpiece tip.
If you press the yellow symbol, the touch screen monitor will display error and
problem resolution information. For more information on responding to alarms,
see page 84.
The level of ultrasonic power displayed on the scale will only be directed to the
handpiece tip when the power Footswitch pedal is pressed fully. Pressing this
Footswitch pedal partially will give an actual power output below the setting
displayed with the exact value depending on the pedal position.
Note that the system only delivers irrigant to the handpiece tip when you press
the Power Footswitch pedal. When you press the Fast Flush Footswitch
pedal, the system ignores the irrigation scale setting and instead applies an
irrigation fast flush rate of about 50 ml/min to the handpiece.
Only the Console is shipped with a power cord. If a Service Module is

employed, this cord must be used for the Service Module instead. A lead comes
from the rear door of the Service Module and plugs into the back of the
Console.
Preparing the CUSA NXT System for Surgery
Warning
Single Use devices are for single patient use only. Do not resterilize, 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. Do not use devices which
have not been properly sterilized. Once used, devices must be disposed of in
accordance with hospital policies.
Using the incorrect wrench set to assemble/disassemble the handpiece may

damage the handpiece.
Failure to center the shroud may cause the handpiece to overheat.

Warning
Tubing kits must never be connected directly to the vacuum source as
contamination will occur.
To avoid injury to surgical personnel, keep fingers away from the pump rollers.
Caution
With correct use of the wrench, it is not possible to over tighten the joint.
However, if the joint is not firmly tightened, the handpiece will not function
correctly and may be noisy and overheat during use.
Do not power the CUSA Selector handpiece without fully priming the handpiece
with irrigant, i.e. irrigant must flow from the tip of the handpiece. Failure to
follow this instruction may result in permanent damage to the handpiece
(internal and/or external components) and may induce heat exchange with the
patient or user, and cause tissue burns.
When using the Console without the Service Module, prior to surgery, place the
Console on a solid surface. The surface must be flat, non-slip and free from
obstruction.
The manifold tubing utilizes PVC tubing which is known to contain DEHP in a
portion of the drainage path. The risk of exposure to pregnant (breast feeding)
women, children and peri-pubescent males is not considered significant for the
following reason(s): Saline solution running through the tubing, as irrigation,
comes into contact with the surgery site during the tissue ablation process.
However, the saline is rapidly aspirated back into the tip along with the ablated
tissue.
Notice
If you are using either a straight or laparoscopic handpiece, the angled
extension is not required.
Write the in-service start date on the contamination guard label before you
install it. See page 79 for details on the contamination guard shelf life.
All of the handpiece and tubing kit components in the CUSA NXT System are
not manufactured with dry natural rubber or natural rubber latex.
When preparing the tubing set, connect the tubing to the pump prior to attaching
the irrigation supply. Attaching the irrigation supply first will fill the tube with
saline and affect the priming time.
Do not remove the aspiration filter from the designated port prior to powering off
the system.

Operating the CUSA NXT System During Surgery
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 and
require replacement before use.
CUSA NXT tips utilize a silicone flue. Compressing the flue against the side of
the vibrating surface along the length of the tip can cause excessive heating
and potential burns along the surgical path.
Excessive loading of CUSA NXT tips at the surgical site can induce heating due
to vibration and acoustic power transmissions into adjacent tissue that may not
be easily visualized due to anatomical constraints.
Thermal management of the surgical site with the aid of the appropriate
irrigation and aspiration settings is essential.
Avoid excessive lateral loading of CUSA NXT tips This may result in equipment
damage and/or injury to the patient or surgical personnel.
damage.
Caution
Before surgery, apply the brakes locks to all wheels on the Service Module to
stop the wheels from rolling.
pass the stylet in from the tip end.
Notice
Press the Power pedal prior to applying the tip of the handpiece to tissue. This
will ensure that the tip is vibrating before load is applied.
Disassembly and Sterilization of CUSA NXT System
Warning

Warning
Electric Shock Hazard – Always unplug the CUSA NXT System before cleaning
it.
Do not allow fluids to enter the Console or Service Module.
Caution
Validation of the steam cycles described have been conducted, however, it is
solely the decision of the hospital to approve the use of these cycles.
Notice
the system.
Do not re-use the tubing kit as this compromises sterility and may lead to
damage of the Console and/or Service Module.
Do not remove the contamination guard situated in the receptacle bay at the
front of the Service Module.
When dismantling and assembling handpieces of different operating

frequencies (24 kHz or 35 kHz), care should be taken to ensure that the correct
tips are fitted to the correct handle section. This is achieved by following the
color coding, bronze for 24 kHz and gold for 35 kHz. Incorrectly fitted
handpieces will either be non-functional or may not perform as intended.

Product damage will result if you do not follow these notices when cleaning the
handpiece:
• Do not immerse the handpiece cable electrical connector in liquid.
• Do not use ultrasonic or automatic washers.
• Do not use chlorinated substances such as bleach solution.
• Do not clean the handpiece with abrasive cleaners or steel wire wool.
Use of System in MRI Environments
Warning
The CUSA NXT System cannot be used in an MRI (Magnetic Resonance
Imaging) environment.

Troubleshooting the CUSA NXT System
Notice
problem resolution information.
Technical Specifications
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 2011on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (recast).

Operating the CUSA NXT outside of the specified environmental conditions

may result in injury to the patient and/or surgical personnel, or cause damage to
the equipment which may result in a delay in patient treatment.
Classification and System Symbols

The following symbols appear on the CUSA NXT System:
Symbol Description
Warning: When you connect the handpiece to the Console,

the handpiece becomes a functional surgical device.
Warning: Dangerous voltage.
Follow instructions for use

Symbol Description
Do not insert fingers. Pinch point can cause injury.
While the Console is connected to the Service Module, do

not push, lean or rest against the front or sides of the
Console. Only use the Service Module handle when moving
the Console.
Protective Earth (ground)
Footswitch Connector
The equipment meets type CF (Cardiac Floating) safety

standards.
Volume Control: Controls the volume of non-alarm tones

VOLUME emitted by the Console.
Equipotential point
Alternating current
"On" power
"Off" power

Symbol Description
System power off/standby
Waste canister
Intravenous bag
Irrigation
Temperature Limitation: Indicates upper and lower

temperature limits.
Humidity Limitations: Indicates upper and lower humidity

limits.
Atmospheric Pressure Limitation: indicates upper and lower

atmospheric pressure limits.
Manufacturer
Date of Manufacture

Symbol Description
Catalogue Number
Serial Number
SN
Please dispose of in accordance with local regulations for

the collection or disposal of waste electrical and electronic
equipment.
Recyclable material
Fragile, handle with care
Do not use if package is damaged
Contains Phthalates (DEHP)
Canadian Standards Association (CSA) Certification Mark
MR Unsafe

Symbol Description
Non-Sterile
Caution, consult accompanying documents
Not manufactured with dry or natural rubber latex
Keep Dry
Do not re-use
Tubing Pathway Symbols

The following symbols define the tubing pathways:
Symbol Description
IV bag; direction of irrigation tubing towards to

peristaltic pump.
Irrigation; above peristaltic pump.

Symbol Description
Handpiece; direction of tubing assembly to

aspiration filter port and pinch valve.
Handpiece; direction of tubing assembly to

aspiration filter port.
Aspiration; direction of tubing assembly to pinch

valve.

Footswitch Symbols
The following symbols appear on the footswitch:
Symbol Description
Power pedal
Fast Flush pedal

®
CHAPTER 2 CUSA NXT SYSTEM SETUP AND
COMPONENTS
Unpacking and Installing the System .......................................................... 17

List of CUSA NXT Components.................................................................... 20
About the Handpieces and Wrench Sets..................................................... 23
About the Tubing Kits ................................................................................... 24
About the Sterile and Non-Sterile Tips ........................................................ 25
Summary of Operating Safety Precautions................................................. 27
Unpacking and Installing the System

When unpacking the system, inspect the shipment for any signs of damage
or loss. If any items are damaged, notify the carrier, the supplier, and retain
all shipping cartons for examination.
Verify that the shipping carton(s) contain the following items:
• Console Carton:
• Console
• Power Cord
• NXT Operator’s Guide
• Footswitch
• Service Module Carton (if applicable):
• Service Module
• Contamination Guard
Caution
If the packaging for a sterile accessory is damaged, do not use the sterile
accessory.
Notice
In the event that you need to return a device to Integra, to prevent any damage,
use the appropriate packaging material.
Chapter 2 • CUSA® NXT System Setup and Components • 17

Commissioning the System
The manufacturer or supplier will normally commission the CUSA® NXT
System. For assistance on the installation procedures, contact the supplier.
After commissioning the system, the supplier will provide training on
preparing, operating and maintaining the system. This will normally take
place as an in-service training course to the appropriate doctors, nurses, and
operating departments.
18 • Chapter 2 • CUSA® NXT System Setup and Components

Initial Setup of Console with the Service Module
1. Place Console in the recess on top of the Service Module.
2. Plug the Service Module cord located in the module’s top rear
compartment into the power connector (1) on the rear of the Console.
3. Plug one end of the detachable power cord into the Service Module’s
power connector (2) on the rear of the module.
4. Connect the aspiration controller cable (3) located in the Service Module’s
top rear compartment to the port on the bottom of the Console (4) inside
the compartment
4
3
5. Tighten both connector screws.

6. Thread the locking thumbwheel located in the Service Module door into
the threaded hole on the bottom of the Console inside the compartment.
Tighten fully.

List of CUSA NXT Components
The CUSA NXT System consists of the Console, Footswitch, and Service
Module (if applicable).
Console
Service Module
About the Console

The Console provides power to the selected ultrasonic handpieces. A touch
screen monitor is used to control the aspiration, irrigation and ultrasonic
power delivered to handpiece. This touch screen also provides access to the
online help system. Note that the Console includes a detachable Power
Cord.
For instructions on using the Console, see page 33.

Support for Service Module
The Console supports the optional Service Module that provides suction and
waste collection (see page 21).
About the Footswitch

The Footswitch contains two pedals for controlling the power (left side,
orange) and Fast Flush (right side, blue).
Power pedal
Fast Flush pedal
The Footswitch also provides a 6m cord that connects to the Footswitch port
located on the rear panel of the Console. For instructions on using the
Footswitch pedals, see page 36. Note that the Footswitch is internally sealed
and may be cleaned by immersion (see page 74).
The Footswitch is also supplied on its own as a spare part (Part #
NXT10001).
Warning
Only operate the footswitch when the base of the footswitch is positioned flat on
the ground, and the front of the footswitch is facing upwards with the pedals
visible and free from obstruction.
About the Service Module

The Service Module provides a convenient source of suction and a holding
area for the aseptic waste collection canister. No further utilities are required.
This module requires a 115 V or 230 V nominal grounded power supply.

Warning
The Service Module includes a spare CUSA NXT contamination guard. For
instructions on setting up the Service Module, see page 59.
Collecting Waste
A receptacle for collecting waste is required between the CUSA NXT
Console and the vacuum source. RECEPTAL® or Bemis® Hi-Flow™ 2000
ml canisters are suggested.
Using Other Suction Source Types

If the CUSA NXT Console will not be used with the Service Module, then the
Console will require another suitable source of suction and waste collection.
Wall or ceiling mounted vacuum points in the operating room or a
free-standing surgical suction unit should operate at a constant vacuum
pressure between 560 mmHg and 620 mmHg with a free air flow capacity of
more than 42 L/min.

About the Handpieces and Wrench Sets
Warning
Only use Integra handpieces and accessories with the CUSA NXT System. The
use of non-Integra handpieces or accessories may result in patient injury.
Non-Integra handpieces or accessories are not supported and are not covered
by warranty.
Handpieces
The CUSA NXT Console supports a range of handpieces:
35 kHz Neurosurgery Handpiece
For the list of CUSA® Selector® handpieces, see page 47. Note that a brush
for cleaning the aspiration channel of the handpiece is supplied with each
handpiece (part # 1523101).
Note that the handpiece and the initially pre-packaged non-sterile tips and
flue(s) are supplied non-sterile and must be disassembled and sterilized
before use according to the instructions in Chapter 6.
Wrench Sets
Use the CUSA Selector wrench set when assembling and disassembling the
handpiece for cleaning and sterilization. Each handpiece is supplied with an
appropriate wrench set.
Each wrench set consists of a stainless steel holder and wrench, connected
by a chain. The cut-outs in the holder are sized according to its use with
specific handpieces.

Guidelines for Using the Wrench Sets
Only use the CUSA Selector wrench set to tighten and loosen tips and
extensions on the handpiece. Always secure the handle of the handpiece in
the holder provided. Never assemble or disassemble the handpiece by
holding the handle in your hand as damage may occur to the handpiece.
Types of Wench Sets

The following table provides the list of part numbers for the different wrench
sets:
Part # Description
1523072M1 For Standard handpieces 1523000M1, 1523000M2,

1523000M3.
1523072M2 For Laparoscopic handpiece 1523000M6.
1523072M3 For Neuro handpieces 1523000M5, 1523000M7, 1523000M8,

1523000M9.
1529056 For MicroSurgical handpieces 1529000M1, 1529000M2.
About the Tubing Kits

The CUSA NXT System requires a supply of sterile tubing kits. Sterile tubing
kits have a three year shelf life.
Part # Description
1517079 CUSA Selector Tubing Kit, disposable, single use, box of 10

(primary tubing kit)
1529036 CUSA Selector MicroSurgical Tubing Kit, disposable, single use,

box of 10
For instructions on using the tubing kits, see page 60.

About the Sterile and Non-Sterile Tips
For Neuro Handpieces
Sterile Tip Sets

The CUSA Selector sterile tip sets include a sterilized tip and flue. Sterile tips
sets have a five year shelf life. The part numbers are:
Part # Description
1523225 24 kHz Neuro Long Sterile Tip Set (5 packs. Each pack
contains one tip and one flue)
1523215 24 kHz Neuro Short Sterile Tip Set (5 packs. Each pack
1523216 Selector® SaberTip™ Sterile Tip Set, for 24 kHz Neuro

Short only (5 packs. Each pack contains one tip and one
flue)
1529165 24 kHz MicroSurgical Sterile Tip Set (5 packs. Each pack

1523235 35 kHz Neuro Sterile Tip Set (5 packs. Each pack contains
one tip and one flue)
1523211 24 kHz Neuro Short Sterile Tip Set (1 tip and 1 flue)
1523221 24 kHz Neuro Long Sterile Tip Set (1 tip and 1 flue)
1523231 35 kHz Neuro Sterile Tip Set (1 tip and 1 flue)
1529161 24 kHz MicroSurgical Sterile Tip Set (1 tip and 1 flue)
*NXT3218 24 kHz Superior Forward Bone Tip Sterile Tip Set (box of 5)
*NXT3218EA 24 kHz Superior Forward Bone Tip Sterile Tip Set (each 1)
*NXT3219 24 kHz Superior Reverse Bone Tip Sterile Tip Set (box of 5)
*NXT3219EA 24 kHz Superior Reverse Bone Tip Sterile Tip Set (each 1)
*NXT3220 24 kHz Inferior Forward Bone Tip Sterile Tip Set (box of 5)
*NXT3220EA 24 kHz Inferior Forward Bone Tip Sterile Tip Set (each 1)
*1523243 35 kHz Extended Length Tip Sterile Tip Set (box of 5)
*1523243EA 35 kHz Extended Length Tip Sterile Tip Set (each 1)
(*These sterile tips have a three year shelf life.)

Non-Sterile Tip Sets
The CUSA Selector non-sterile tip sets include a non-sterile tip and flue.
Non-sterile tips and flues must sterilized before use according to the
instructions in Chapter 6. The part numbers are:
Part # Description
1523067 24 kHz Neuro Tip Set for Neuro Long and Neuro Short (5 packs.
Each pack contains one tip and one flue)
1529066 24 kHz MicroSurgical Tip Set (5 packs. Each pack contains one tip
and one flue)
1523078 35 kHz Neuro Tip Set (5 packs. Each pack contains one tip and
one flue)
1523066 35 kHz Ultrafine MicroTip™ Set (5 packs. Each pack contains 1 tip
and 1 flue)
1529064 24 kHz Microsurgical Ultrafine Tip Set (5 packs. Each pack

contains 1 tip and 1 flue)
1529063 24 kHz MicroTip™ Set (1 tip/5 flues)
1523064 35 kHz Neuro Tip Set (1 tip/5 flues)
1523056 24 kHz Ultrafine MicroTip™ (1 tip and 1 flue)
1529065 24kHz Microsurgical Ultrafine Tip (1 tip and 1 flue)
1523077 35kHz Ultrafine MicroTip™ ( 1 tip and 1 flue)
For Standard Handpieces

See page 48 for information on non-sterile tips and flues.

Summary of Operating Safety Precautions
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in
surgical procedures where fragmentation, emulsification and aspiration of
soft and hard (e.g. bone) tissue is desirable, including Neurosurgery,
Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and
Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological
surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Please note that this operator’s manual provides information only on
operating the system. This manual does not provide instructions for any
specific surgical procedure.
It is imperative that the procedures described in this manual are followed
carefully. Using the system in any other manner may result in personal injury.
Using the Handpieces
Warning
Warning
When the handpiece is connected to a CUSA NXT 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 pressing the Power Footswitch pedal to operate the handpiece, do not
allow the tip of the handpiece to come into contact with any object except for the
target tissue at the operating site. Touching the tip while powered can result in
personal injury.
Warning

Caution
Contact of the moving tip against a hard surface, e.g. a metal instrument tray,
may damage the tip of the handpiece and require replacing the tip before use.
Do not use a handpiece with a broken tip.
Sterilizing Backup Handpieces

The CUSA Selector handpiece may be sterilized by steam autoclave (see
page 77). Integra LifeSciences recommends that a sterile backup handpiece
and associated accessories be available for immediate use in the event of
any contamination or malfunction during surgery. Make sure to sterilize the
appropriate wrench set with the handpiece so the wrench set may be used to
assemble the handpiece and tip. The wrench set should be kept sterile so
that it may be used to replace the tip, if necessary.
Warnings and Hazards when Using the System
Class 1 Type CF
The CUSA NXT System is Class 1 type CF Patient connected electrically
isolated equipment (reference IEC 60601).
Warning
Risk of explosion. Do not use in the presence of flammable anaesthetic gases
or other volatile solvents.
Warning
Electrical shock hazard. Do not remove cover. Refer servicing to authorized
service personnel.
Warning
To avoid personal injury or damage to the tip, do not allow the tip of the
handpiece to contact any operator or hard surfaces or anything other than the
target tissue when powered.
Warning
For continued protection against fire and electrical hazard, replace fuse only
with same type and rating.
Caution
Biomedical technicians should note that special attachments are required to
connect the ultrasonic handpieces to test equipment used for electrical
safety testing. Application of a vibrating handpiece to test equipment
without these attachments may result in damage to both the test equipment
and the handpiece.

Tightening the Handpieces with the Wrench Kits
Caution
Only use the CUSA Selector wrench kit to tighten tips and extensions on
the transducer of the handpiece. Always secure the handle of the
handpiece in the holder provided. Never dismantle or assemble the
handpiece without placing the handle section of the handpiece in the holder.
Failure to comply with this instruction could result in permanent damage to
the transducer and will invalidate the warranty.
Clearing Blocked Handpieces
Caution
Do not attempt to clear a blocked handpiece by passing the stylet down the
rear inlet of the handpiece. This may result in damage to the handpiece.
Always pass the stylet from the tip end.
Inspecting Handpiece Tips for Damage
Warning
Do not use a damaged handpiece with the CUSA NXT System.This may result
in injury to the patient or surgical personnel. A damaged handpiece must be
returned to the manufacturer for repair. Do not attempt to dismantle the rear
handle sections of the handpieces; it does not contain any serviceable parts.
Caution
Do not use a handpiece with a broken tip. Inspect the tip for damage prior to
use. If the tip is damaged it may be replaced by the operator.
Priming the Handpieces
Caution
Do not use dry air sterilization methods involving temperatures in excess of
139 °C (282 °F); this may damage the handpiece.
Caution
Do not power up the CUSA Selector handpiece without fully priming the
handpiece with irrigant (i.e. irrigant must flow from the tip of the handpiece).
Failure to prime the handpiece could result in permanent damage to the
handpiece (internal and/or external components) and may induce heat
exchange with the patient or user, and cause tissue burns.

Notice
To prevent fluid flowing into the vacuum line, only use a canister that has a non
return valve.
Components for Single Use Only

The CUSA Selector tubing kit is supplied sterile for single use only. All flues
are for single use only.
Warning
Use of the handpiece outside of the specified conditions can result in high
operating temperatures.
Warning
Contact between the unprotected part of the tip and non-target tissue can result
in burns.
Warning
Use of the handpieces in a damaged condition can result in an electric shock
hazard.
Warning
Failure to maintain the CUSA NXT System in accordance with the instructions
in this manual can compromise safety.
Warning
Use the single use CUSA Selector tubing, and single use tips and flue sets
once only. Re-use may result in a biological hazard.
Warning
Use single use tips for a single procedure only. Re-using single use tips may
result in tip fragmentation and injure the patient or user.

Requirements for Servicing the System
Do not remove any instrument covers on the system or touch screen monitor.
The CUSA NXT Console contains no user serviceable parts and the system
must be serviced only by qualified Integra service engineers. Interference
with the Console by any other personnel may invalidate the warranty and
may result in injury.
Explosion and Fire Hazards
Warning
Do not use in the presence of flammable anaesthetic gases or other volatile
solvents.
Latex Information
The components of the CUSA Selector handpieces that directly or indirectly
come into contact with the patient are not manufactured with dry natural
rubber or natural rubber latex.


CHAPTER 3 USING THE CONSOLE, SERVICE MODULE,
AND HANDPIECES
About the Console Functionality ................................................................. 33

Using the Touch Screen Monitor ................................................................. 38
Using the Footswitch Pedals ........................................................................ 36
About the Service Module Functionality ..................................................... 44
About the Handpiece Functionality ............................................................. 47
List of Handpieces ......................................................................................... 47
About the Console Functionality

The CUSA® NXT Console contains the electronics, pumps, and mechanical
parts for providing power to the selected handpiece used during ultrasonic
surgery.
To control the setpoint levels and for online help information, the Console
uses:
• A touch screen monitor for specifying the aspiration, irrigation, and
ultrasonic setpoint levels and for accessing online help. For instructions
on using this monitor, see page 38.
• A Footswitch containing two pedals for controlling the ultrasonic power
and the rate of irrigation fluid. For instructions on using this Footswitch,
see page 36.
For information on the parts of the Console panels, see pages 34 to 35.
Chapter 3 • Using the Console, Service Module, and Handpieces • 33

About the Left Console Panel
The following table describes the components and connection points on the
left side of the Console.
1 4
2 3
Component Description
1 Irrigation Pump A peristaltic pump that pumps irrigant from the IV bag to the handpiece. This
pump clamps into place across the irrigation tube of the disposable tubing set.
Note that the direction of tubing connections to the pump are illustrated on the
panel.
2 Aspiration Control Port The port designated for the aspiration filter of the tubing kit
3 Pinch Valve A normally open valve where the aspiration tube is routed before connecting to
the suction system. When the Power Footswitch pedal is released, this valve
closes momentarily and shuts off the suction and facilitates the release of
tissue from the tip of the handpiece. When the Fast Flush Footswitch pedal is
pressed, this valve closes and stops the aspiration. The valve re-opens when
the Fast Flush Footswitch pedal is released.
4 Handpiece Connection Port Connection port for the 24 kHz handpieces only.
5 IV Pole The pole that holds the bag of irrigation fluid. The pole will support a 500 ml or
1000 ml irrigation bag. If a larger bag is used, place the bag on a separate
irrigation stand. To raise and lower the pole, adjust the locking nut at the
bottom of the pole.
34 • Chapter 3 • Using the Console, Service Module, and Handpieces

About the Rear Console Panel
The following table describes the components and connection points on the
rear side of the Console:
2
4
5
1 6
1 AC Power Inlet An international standard inlet which accepts the power cord supplied with the Console
or the power lead if used with the Service Module. An appliance coupler can be used to
isolate the system from the mains power source.
Notice: To isolate the CUSA NXT from the AC power supply, you must
unplug the Console from the power source.
2 Power Button Turns the CUSA NXT Console on and off.
Notice: When shutting down the system, the button has a blue light which
remains on while the system goes through a shut down process.
It does not immediately go out when pressed.
3 Cooling Fan Air Outlet Air, used to cool the internal electronic systems, leaves the Console through this grill,
which should be kept clear of any obstruction.
4 Footswitch Connection The port designated for the Footswitch plug.

Port
5 Equipotential Point This external ground pin is connected to the main internal instrument grounding point
and is used in some countries as the point for attaching a separate grounding lead.
This allows for the connection of a Potential Equalization 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.
6 Volume Control Knob Controls the volume of non-alarm tones emitted by the Console.

Connecting Handpieces to the Console
The Console contains 3 color-coded ports for connecting the different types
of handpieces. Two of the ports appear on the front panel, while the third
port appears on the left panel.
35 kHz Handpiece 24 kHz MicroSurgical

Handpiece
Only connect one handpiece to the system at the same time. If you connect
more than one handpiece at the same time, the system generates an alarm,
and stops the ultrasonics.
To connect the handpiece, align the red dot on the handpiece plug with the
red dot on the handpiece connection point, and gently insert the plug until
you hear a clicking sound.
Warning
Note the following color codes for each handpiece type:
Color Panel Handpiece Type
Red Left 24 kHz
Green Front 35 kHz
Black Front 24 kHz MicroSurgical
For instructions on assembling the handpiece, see page 56.
Using the Footswitch Pedals

The Footswitch contains two pedals:
• Power (left, orange)

• Fast Flush (right, blue).
Power
pedal
Fast Flush pedal
To connect the Footswitch to the Console, attach the Footswitch cord to the
appropriate port on the rear of the Console panel. Align the red dot on the
Footswitch plug with the red dot on the Footswitch connection point, and
gently insert the plug until you hear a clicking sound.
Note that the Footswitch is internally sealed and may be cleaned by
immersion (see page 74).
Pressing the Power Pedal

Pressing this pedal will:
• Switch on the irrigation at the preset rate indicated on the front panel
irrigation display.
• Switch on the ultrasonic power to a level which varies in an approximately
linear fashion from zero (when the pedal is not pressed), to the maximum
value indicated on the front panel power display (when the pedal is fully
pressed).
Notice
After releasing the Power pedal, the pinch valve operates momentarily to block
aspiration and facilitate tissue release from the handpiece tip.
Notice
Do not press the ultrasonics Power pedal on the Footswitch during system
startup or while connecting components to the Console.

Activating the Handpiece
To activate the handpiece, press the Power pedal for at least 2 seconds.
Caution
Pressing and releasing the Power pedal too quickly may result in a Handpiece
Tip Initialization failure. If this occurs, disconnect the handpiece, verify proper
tip assembly, and then reconnect the handpiece and try again.
Pressing the Fast Flush Pedal

Pressing this pedal will:
• Switch on irrigation at a rate of 50 ml/min. Note that the irrigation setting
on the front panel display has no influence upon the irrigation rate when
the Fast Flush pedal is pressed independently.
• Stop aspiration (until the pedal is released).
Using the Touch Screen Monitor

The CUSA NXT Console provides a touch screen monitor for viewing and
controlling the power, irrigation, and aspiration levels during an ultrasonic
case.

This touch screen provides the following tools:
Tools Description
1 Status / Alarm Symbols Displays colored symbols to indicate the status of the major ultrasonic
components. For specific information, see the page 39.
2 Ultrasonic Control Scales Controls the power, irrigation, and aspiration settings during an ultrasonic case
(see page 41).
3 Information Panel Displays general information regarding the accumulated ultrasonic time and the
current vacuum levels (see page 43).
4 Menu Buttons Displays menus for priming the handpieces, customizing user settings, and
viewing online help (see page 44).
For instructions on maintaining the touch screen, see page 80.
Status/Alarm Symbols
The CUSA NXT System activates an alarm to indicate a technical problem
with the system. All alarms on the CUSA NXT are technical, low-priority
alarms, for example, mechanical or equipment related. There are no
physiological alarms on the CUSA NXT System.
The five symbols that appear on top of the touch screen provide status
information on the major ultrasonic components.
Normal Alarm Alarm

Symbol Alarm Indicator (When Yellow)
Status Classification Priority
Signifies an error in the aspiration

Aspiration Technical Low
process.
Signifies an error in the ultrasonic

Power Technical Low
generator.
Signifies a fault in the Footswitch or

Footswitch Technical Low
associated wiring.
Signifies that a handpiece is not

Handpiece Technical Low
connected.
Signifies an error in the electronics or

General Technical Low
power supplies.

During normal operation, all the symbols appear green. If an error occurs
with any of the major components, an alarm will sound and the respective
symbol will turn from green to yellow.
Warning
damage.
Notice
problem resolution information. For more information on responding to alarms,
see page 84.
There is no method to silence alarms from the touch screen, 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 activated on
the touch screen, the alarm remains activated when you power the system
on again.The only method of turning off the alarm on the touch screen is to
resolve the corresponding alarm.
Recommended: When you set up the CUSA NXT System for surgery, make
sure that the touch screen is always clearly visible to the surgeon in the event
of an alarm, and the alarm tone is audible. Remove any obstructions that
may block the surgeon’s view of the touch screen.
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 78dB.

Adjusting the Ultrasonic Control Scales
Use the power, irrigation, and aspiration scales to control the major
ultrasonic settings during a case.
Adjusting the Power Level

Use the power scale (orange) to specify the ultrasonic power output (tip
amplitude). The power settings range between 10% and 100%. The default
power setting is 10%.
Note that raising the power setting will increase
the vibration of the handpiece tip and thus
increase tissue fragmentation rate. To adjust the
power by 5% increments, use the arrows to the
right of the scale. To adjust the power by 10%
increments, press the segment bars on the scale.
Notice
The level of ultrasonic power displayed on the scale
will only be directed to the handpiece tip when the
power Footswitch pedal is pressed fully. Pressing
this Footswitch pedal partially will give an actual
power output below the setting displayed with the
exact value depending on the pedal position.

Adjusting the Irrigation Level
Use the irrigation scale (blue) to specify the rate
of irrigation that will be delivered to the
handpiece. The irrigation rate ranges between 2
and 20 ml/minute. The default flow is 3 ml/min.
The accuracy of the irrigation flow is +/- 20% of
setting or +/-1 ml/min, whichever is greater. To
adjust the rate by 1 ml/minute increments, use the
arrows to the right of the scale. To adjust the rate
by 2 ml/minute increments, press the desired
segment on the scale.
Notice
Note that the system only delivers irrigant to the
handpiece tip while pressing the Power Footswitch
pedal. If pressing the Fast Flush Footswitch pedal,
the system ignores the irrigation scale setting and
instead applies an irrigation fast flush rate of about
50 ml/min to the handpiece.

Adjusting the Aspiration Level
Use the aspiration scale (green) to specify the
aspiration rate of the total available suction of the
source of vacuum employed. The aspiration rate
ranges from 15% to 100%. The default setting for
aspiration is 100%. The accuracy of the
aspiration rate is +/-50 mm Hg of available
aspiration. To adjust the rate by 5% increments,
press the arrows to the right of the scale. To
adjust the rate by 10% increments, press the
segment bars on the scale. Note that typical
aspiration rates are between 30% and 100%.
Warning
The minimum aspiration level setting is 15%. This
ensures proper handpiece cooling and
performance. Insufficient aspiration can cause
premature handpiece or tip failures and may
induce heat exchange with the patient or user, and
cause tissue burns.
Verifying General Ultrasonic Information

Use the information panel to determine the
general status of the current operating modes and
equipment selection. This panel provides the
following information:
Symbol Description
Displays the total accumulated ultrasonic

time since the machine was powered on.
This value will reset to 00:00 if the
machine is turned off for more than 30
minutes.
Displays the current vacuum level from

the aspiration source. This level is
measured in mm hg units.

Displaying Menus for Prime Mode, Customized Settings, and Online Help
Use the menu buttons to access features for
priming the handpiece, customizing user settings,
and displaying online help. Note the following
buttons:
Button Description
prime Displays the prime panel for priming the

handpiece for surgery (see page 63).
settings Displays options for saving customized

settings and specifying different languages
(see page 70).
help Displays the online help system for

accessing information on performing
common tasks (see page 2).
About the Service Module Functionality

The Service Module provides a convenient, mobile base for the CUSA NXT
Console, as well as a source of suction and waste collection. It is controlled
from the Console and has no user accessible controls.
Front Rear
4
1
5
2
6

The Service Module contains the following components:
1 Suction Port In the top center of the front section of the Service Module, there is a
protective filter and an attachment point for the suction tubing which leads
internally to the vacuum pump. The protective filter (part # NXT00005) should
be replaced every six months or earlier if contaminated. Note that this filter is
different from the type used in the disposable tubing kit.
2 Container Receptacle The space at the front of the Service Module for accommodating a variety of
commercially available waste containers. For instructions on the tubing
connections for the canister, see page 59.
3 Castors The Service Module provides four antistatic rotating castors. Unlocked, both
front and rear casters roll easily and rotate freely. When locked, the front
casters will not roll, and the rear casters will not roll or rotate.
4 Power Lead A short lead with a socket which fits the AC power inlet on the rear panel of
the Console. An appliance coupler can be used to isolate the system from the
mains power source.
5 Communication Cable A short cable that provides communication from the Console to the Service
Module. The cable plugs into the bottom of the Console when it is placed on
the Service Module.
6 Storage Area for Footswitch and The enclosure behind the rear door of the Service Module that
Power Cord accommodates the Footswitch and power cord of the Console when the
system is not in use.
7 AC Power Inlet An international standard inlet which accepts the power cord supplied with the
Console.
8 Power Switch Turns the power to the Service Module on and off. This switch must be
turned on to power on the CUSA NXT Console.

For instructions on using the Service Module (or other sources for suction
and waste removal) during a surgical procedure, see page 59.
Rear View of Console Attached to Service Module
Console
Service Module
Caution
Do not store anything in the storage area in the back of the Console while the
system is running.
Notice
Only the Console is shipped with a power cord. If a Service Module is employed,
this cord must be used for the Service Module instead. A lead comes from the
rear door of the Service Module and plugs into the back of the Console.

About the Handpiece Functionality
Each CUSA® Selector® handpiece contains the following components:
2 3
5 4
Components Description
1 Tip The titanium alloy tip is unique to each handpiece, having a designated thread to
minimize the possibility of attaching it to the wrong handpiece.
2 Shroud Black heat resistant shrouds that are interconnected by snap-in push fittings with
the exception of the laparoscopic handpiece which has a screw thread joint. The
shrouds cover one or two titanium alloy parts:
• All handpieces contain a tip.
• Angled handpieces also include an angled extension.
These titanium alloy parts are fitted with screw threads and are removable for
cleaning and sterilizing using the appropriate handpiece wrench set.
3 Handle Contains the piezoelectric transducer which includes an array of piezo ceramic
elements to convert the power signal from the CUSA NXT Console into mechanical
vibration at 24 kHz or 35 kHz depending on the handpiece type.
4 Piezoelectric Transducer Generates negligible heat and requires no external cooling system. Each
(Internal) handpiece conforms to the highest levels of electrical safety. All the handpieces
are Type CF (Cardiac Floating) with a patient leakage current of less than 10  A.
Note that the rear section of the handpiece does not contain any user-serviceable
parts. Under no circumstance should it be tampered with.
5 Flue The tip of the handpiece is covered by a one-piece or two-piece clear flue to
protect tissues around the tip and ensure clarity of view during operation.
For instructions on maintaining the handpieces, see page 77.
List of Handpieces
The following section provides the lists of Standard, Neurosurgical and
MicroSurgical handpieces supported by the CUSA NXT System, and the tip,
flue and shroud that correspond with each handpiece.

List of Standard Handpieces
24 kHz Straight Handpiece (part # 1523000M1)
Part # Description Picture
-- Transducer assembly
1523013 Standard tip,

non-sterile, each 1
1523042 Flue (disposable),

non-sterile, single use,
box of 20
1523017 Straight shroud, each1
24 kHz Angled Handpiece (part # 1523000M2)
1523015 Extended Fine Tip,

non-sterile, each 1

box of 20
1523049 Angled shroud, each 1
1523033 Angled extension, each

1
1523035 Extension shroud, each

1

35 kHz Straight Handpiece (part # 1523000M3)
1523014 Standard tip,

non-sterile, each 1

box of 20
1523018 Straight shroud, each 1
24 kHz Laparoscopic Handpiece (part # 1523000M6)
1523029 Laparoscopic Tip,

non-sterile, each 1

box of 20
1523028 Step amplifier, each 1
1523030 Laparoscopic Shroud,

each 1
1523031 Laparoscopic Shroud

extension, each 1
About the Laparoscopic Handpieces

The Laparoscopic handpiece is a variant of the standard straight 24 kHz
CUSA Selector handpiece in which the front of the handpiece is extended to
facilitate its use in laparoscopic surgery. This handpiece has an external
diameter along its working length of 10 mm. It can be used with both reusable
and disposable 10/10.5 mm trocar introducers.
The Laparoscopic handpiece has been designed for the dissection and
selective removal of unwanted tissue in gastrointestinal surgery. When used
in a gentle but continuously moving action, it is capable of removing cellular
tissue and fat while sparing fibrous structures such as nerves, blood vessels
and membranes. Note that the Laparoscopic handpiece is fitted with a clamp
at the rear end through which the aspiration/irrigation tube should be passed.
The laparoscopic handpiece is not intended for liposuction procedures.

List of Neurosurgical Handpieces
24 kHz Neurosurgical Short Handpiece (part # 1523000M7)Selector
1523067 24 kHz Ultrafine

MicroTip™ Set (includes
Flue)
non-sterile, 5 packs, where
each pack contains 1 tip
and 1 flue
1523056 24 kHz Neuro Short Tip Set

(1 tip and 1 flue)
1523215 Ultrafine MicroTip™ Set

(single-use), sterile, 5
packs, where each pack
contains 1 tip and 1 flue
1523216 Selector® SaberTip™

(single-use), sterile, box of
5
NXT3218 Superior Forward Bone

Cutting Tip, box of 5
NXT3218EA Superior Forward Bone

Cutting Tip, each 1
NXT3219 Superior Reverse Bone

NXT3219EA Superior Reverse Bone

Cutting Tip, each 1
NXT3220 Inferior Forward Bone

NXT3220EA Inferior Forward Bone

Cutting Tip, each 1
1523049 Angled shroud
1523053 Angled extension
Notice
The flues are packed in either a sterile or non-sterile Tip Set.

Notice
• The CUSA NXT Bone Tips can only be used with the CUSA NXT System. They cannot
be used with the CUSA Selector System.
• The CUSA NXT Bone Tips can only be used with the 24 kHz Neurosurgical handpiece
(part # 1523000M7).
SaberTip for 24 kHz Neurosurgical Short (part #1523216)

The Selector SaberTip is an additional tip available only for the 24 kHz
Neurosurgical Short handpiece. This tip is designed specifically to
selectively remove hard tissue such as bone. It has an abrasive surface that
is oriented superiorly at the distal end of the tip.
For specific information on using this device, see the Selector SaberTip
Instructions for Use that comes with the Selector SaberTip.
NXT Bone Tips for the 24 kHz Neurosurgical handpiece (part # 1523000M7)
The NXT Bone Tips are additional tips available only for the 24 kHz
Neurosurgical handpiece.
Three types of NXT Bone Tips are available:
• The Superior Forward Bone Tip has an abrasive surface that is oriented
superiorly at the distal end of the tip.This tip is principally designed to
fragment, emulsify, and aspirate bone generally encountered in surgical
approaches.
• The Superior Reverse Bone Tip has an abrasive surface that is oriented
superiorly at the distal end of the tip.This tip is principally designed to
fragment, emulsify and aspirate bone by withdrawing the surgical tip away
from the target area towards the surgeon.
• The Inferior Forward Bone Tip has an abrasive surface that is oriented
downward to the surgical tip bend. This tip is principally designed to
fragment, emulsify, and aspirate bone generally encountered in surgical
approaches.
For specific information on using the NXT Bone Tips, see the Integra CUSA
® ®
NXT Bone Tips Instructions for Use that comes with the NXT Bone Tips.

24 kHz Neurosurgical Long Handpiece (part # 1523000M5)
1523067 24kHz Ultrafine MicroTip™ Set

(single use) non-sterile, 5 packs,
where each pack contains 1 tip
and 1 flue
1523225 Neuro Long Tip Set (single use)

sterile, 5 packs, where each
pack contains 1 tip and 1 flue
1523221 24 kHz Neuro Long Sterile Tip

Set, 1 tip and 1 flue
1523045 Clear extension flue, each 1
1523052 Angled extension, each 1
Notice

35 kHz Neurosurgical Handpiece (part # 1523000M9)
1523064 Neuro Tip Set, non-sterile, 1 tip/

5 flues
1523235 Neuro Tip Set (single use)

sterile, 5 packs, where each
pack contains 1 tip and 1 flue
1523231 Neuro Tip Set (single use),

sterile, 1 tip and 1 flue
1523243 Extended Length Tip (single

use), sterile, box of 5
1523243 Extended Length Tip (single

EA use), sterile, each 1
Notice
The flue and extension shroud are packaged in either a sterile or non-sterile Tip
Set.
Notice
• The Extended Length Tips are compatible with both the CUSA NXT and CUSA
Selector Systems.
• The Extended Length Tip can only be used with the 35 kHz NeuroSurgical Handpiece
(part # 1523000M9).

List of MicroSurgical Handpieces
24 kHz MicroSurgical Handpiece (part # 1529000M2)
1529066 MicroSurgical Tip Set (single

use), non-sterile, 5 packs, where
each pack contains 1 tip and 1
flue

use), sterile, 5 packs, where
each pack contains 1 tip and 1
flue

use), sterile, 1 tip and 1 flue
1529063 Microsurgical Tip Set, reusable,

non sterile, 1 tip / 5 flues
Notice

®
CHAPTER 4 PREPARING THE CUSA NXT SYSTEM
FOR SURGERY
List of Requirements ..................................................................................... 55

Assembling the Handpieces......................................................................... 56
Preparing the System .................................................................................... 59
Priming the Handpieces ................................................................................ 63
Testing the Alarm Tone ................................................................................. 65
List of Requirements
Preparing the CUSA® NXT System for surgery requires the following items:
• Console
• Footswitch
• Service Module or wall suction outlet
• One waste collection canister
• Sterile Tubing Kit
• Sterile intravenous fluid in container (500 ml isotonic saline is
recommended)
• Two sterile handpieces that are fitted with tips (one for the procedure and
a second one for backup)
• Appropriate handpiece wrench set
The CUSA NXT 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.
Warning
Single Use devices are for single patient use only. Do not resterilize, 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. Do not use devices which
have not been properly sterilized. Once used, devices must be disposed of in
accordance with hospital policies.
Chapter 4 • Preparing the CUSA® NXT for Surgery • 55

Caution
The manifold tubing utilizes PVC tubing which is known to contain DEHP in a
portion of the drainage path. The risk of exposure to pregnant (breast feeding)
women, children and peri-pubescent males is not considered significant for the
following reason(s): Saline solution running through the tubing, as irrigation,
comes into contact with the surgery site during the tissue ablation process.
However, the saline is rapidly aspirated back into the tip along with the ablated
tissue.
Assembling the Handpieces

Assemble the CUSA® Selector® handpiece in the sterile field.
All handpieces and non-sterile tips and flues should be disassembled and
sterilized prior to use, according to the instructions in Chapter 6:
1. Using the appropriate wrench set, secure Flat 2 (2) of the handpiece into
the designated slot of the holder.
2. Using your fingers, screw the silver angled extension into the handle.
Notice
3. Using the wrench, tighten the extension by turning it clockwise.

Caution
With correct use of the wrench, it is not possible to over tighten the joint.
However, if the joint is not firmly tightened, the handpiece will not function
correctly and may be noisy and overheat during use.
Warning
Using the incorrect wrench set to assemble/disassemble the handpiece may
damage the handpiece.
56 • Chapter 4 • Preparing the CUSA® NXT for Surgery

4. Reposition the handpiece into the holder, securing Flat 1 (1) of the angled
extension into the designated slot of the holder.
5. Using your fingers, screw the tip into the angled extension.
6. Using the wrench, tighten the tip by turning it clockwise.
7. Remove the handpiece from the holder.
8. Attach the black shroud onto the handpiece by centering and aligning the
shroud with the silver angled extension.
Warning
Failure to center the shroud may cause the handpiece to overheat.

9. Attach the clear flue onto the shroud until firmly placed in position.
See page 36 for information on connecting the handpiece to the Console.
The handpiece is now ready for use.

Preparing the System
Preparing the system for surgery requires setting up the following items:
• Suction source
• IV Bag
• Tubing Kits
• Footswitch
Prepare the Suction Source

1. Depending on the type of suction source being used, do one of the
following:
• If the Service Module is being used with the Console, position it in a
convenient location outside the sterile field.
• Recommended: Position the Console so that the touch screen is
clearly visible to the surgeon at all times and the alarm tone is
audible. Remove any obstructions that may block the surgeon’s
view of the touch screen. Do not position the Console in a way that
blocks access to the mains connector.
• If the Service Module is not being used, place the Console on a solid
surface outside the sterile field. Note that the external suction source
must operate at a minimum vacuum pressure between 560 mmHg and
620 mmHg with a free air flow capacity more than 42 L/min.
Caution
When using the Console without the Service Module, prior to surgery, place the
Console on a solid surface. The surface must be flat, non-slip and free from
obstruction.
2. If applicable, place a canister liner in the suction canister and connect the
tubes in the suction canister.
3. Ensure that a contamination guard is fitted to protect the vacuum pump in
the Service Module.
Warning
Tubing kits must never be connected directly to the vacuum source as
contamination will occur.
Notice
Write the in-service start date on the contamination guard label before you
install it. See page 79 for details on the contamination guard shelf life.
4. Connect tubing from pinch valve (1) to patient waste port on canister.

5. Connect tubing from the contamination guard (2) to the vacuum port (3)
on the canister.
3 2
Prepare the IV Bag

1. Lift the IV pole on the rear of the Console to an elevated position and turn
the knurled locking ring clockwise to secure the extended section. Place
the sterile intravenous fluid container onto the hook at the end of the pole.
2. Place the sterile handpiece and accessories in the sterile field and
unwrap.
Prepare the Tubing Kits

1. Open the appropriate tubing kit onto the sterile field and select the desired
handpiece(s).
2. Inspect all tubing before use. Note the following:
• For the MicroSurgical handpiece, have the assistant carefully peel
back the outer covering of the MicroSurgical tubing kit (#1529036) and
offer the sterile contents to the sterile operator.
• For Primary Tubing Kit for Standard handpieces, have the assistant
carefully peel back the outer covering of the Primary tubing kit
(part#1517079) and offer the sterile contents to the sterile operator.

3. Retain the yellow stylet and white hose clips in the sterile field.
Notice
All of the handpiece and tubing kit components in the CUSA NXT System are
not manufactured with dry natural rubber or natural rubber latex.
4. Connect the tubing to the handpieces. Attach the double lumen tube from
the standard tubing kit to the irrigation (1) and aspiration (2) ports on the
back of the handpiece.
2
1
Back End of Handpiece
If you are using the MicroSurgical handpieces:

• For the MicroSurgical handpiece, attach the micro tubing kit to the
irrigation (1) and aspiration (2) ports on the back of the handpiece.
Connect the other end of the tubing to the standard tubing kit.
5. Using the white hose clips supplied with the tubing kit, secure the tubing
and handpiece cord.
6. Depending on the Console location, reserve the desired amount of tubing

to be used in the sterile field.
7. Hand the remaining tubing to the Console location in the non-sterile area.

Connect Tubing to Console
Warning
Follow the diagram on the side label of the Console:

Notice
When preparing the tubing set, connect the tubing to the pump prior to
attaching the irrigation supply. Attaching the irrigation supply first will fill the
tube with saline and affect the priming time.
1. Route the smaller irrigation tubing through the peristaltic pump (1) and
secure latch.
2. Route the aspiration tube through the pinch valve (1) and connect to the
patient port on the suction canister.

3. On the left side of the Console, connect the aspiration filter to the
designated port (2).
Notice
the system.
Position the Footswitch

Connect the footswitch, see page 36. Position the footswitch where it is easily
accessible to the surgeon.
Priming the Handpieces

Automatic priming is a feature on the CUSA NXT System. Manual methods
for priming used with previous versions of Selector may still be performed,
however, you must at least start and then stop the initial prime cycle in order
to proceed with system operation. If any alarm conditions exist upon initial
startup (e.g. handpiece or footswitch not connected), the prime screen will
not appear until these alarms are resolved.

1. Turn on the system by pressing the main power button located on the rear
panel of the Console and on the Service Module (if utilized); the prime
screen will appear automatically.
2. On the prime screen, press the start button; the CUSA NXT will start to
prime the handpiece and display a progress bar. To stop the priming
process at any time, press the stop button.
Caution
Do not power the CUSA Selector handpiece without fully priming the handpiece
with irrigant, i.e. irrigant must flow from the tip of the handpiece. Failure to
follow this instruction may result in permanent damage to the handpiece
(internal and/or external components) and may induce heat exchange with the
patient or user, and cause tissue burns..
3. During the priming process, verify that fluid completely fills the line to the
handpiece and irrigant flows from the tip of the handpiece. If irrigant does
not flow from the tip, press the prime button and re-start the priming
process until fluid starts to flow from tip. To stop the priming process at
any time, press the stop button.

Completing the Priming Process
After priming the handpiece, the main screen will appear. For an overview of
main screen, see page 38.
Testing the Alarm Tone

To verify the alarm tone functions correctly, you must intentionally trigger an
alarm on the CUSA NXT System, for example, disconnect the footswitch
from Console:
1. Disconnect the footswitch from the Console at the footswitch connector.
2. Verify that the footswitch alarm triggers on the system.
3. Verify that the system sounds the alarm tone.
If the alarm tone doesn’t sound, contact your Integra representative.
The system is now ready for use (see Chapter 5).


®
CHAPTER 5 OPERATING THE CUSA NXT SYSTEM
DURING SURGERY
Operating the System During Surgery ........................................................ 67

Warnings Relating to the Tips During Surgery ........................................... 69
Customizing the User Settings..................................................................... 70
Operating the System During Surgery

After setting up the system, the system may be used for surgery.
Warning
Warning
Ignoring alarms on the CUSA® NXT System while continuing to use the system
damage.
Caution
Before surgery, apply the brakes locks to all wheels on the Service Module to
stop the wheels from rolling.
Note the following guidelines when using the CUSA NXT during surgery:
Chapter 5 • Operating the CUSA® NXT During Surgery • 67

• Increasing the power setting (orange) increases cell disruption at the
handpiece tip.
• Increasing the irrigation setting (blue) increases the irrigation flow.
• Increasing the aspiration setting (green) increases the suction at the
handpiece tip.
During the surgical procedures, you may adjust these variables by adjusting
the appropriate scales on the touch screen.
1. Verify that the handpiece is fully primed.
2. Set the aspiration, irrigation, and power levels to the desired settings. If
desired, use the presets option to select the pre-defined settings (see
page 71). If there are no saved settings, use the touch screen to set the
desired aspiration and irrigation levels. Note the following:
Levels Description
aspiration Adjust the aspiration scale to the required level.
irrigation Adjust the irrigation scale to the required level. Note that
irrigation levels between 2 and 8 ml/min are typically used.
power Adjust the power scale to the required value. Note that power
settings between 40% and 100% are typically used.
3. Hold the handpiece in the sterile field and verify the following:
• The tip is not in contact with any object.
• The aspiration and irrigation tubes are free from kinks or other
obstructions.
4. Press the Power pedal on the Footswitch for at least 2 seconds to activate
the handpiece. Verify that a fine aerosol spray of irrigant appears at the
tip showing that ultrasonic power is present.
Notice
In Step 4, pressing and releasing the Power pedal too quickly may result in a
Handpiece Tip Initialization failure. If this occurs, disconnect the handpiece,
verify proper tip assembly, and then reconnect the handpiece and try again.
The system is now ready for surgical use.

5. To operate the ultrasonic aspirator, press the Power pedal. Aspiration
operates continuously and irrigation is activated at the pre-set level when
the pedal is pressed. Ultrasonic power is controlled in a linear fashion -
increasing as the Power pedal is pressed further until, at full depression, it
reaches the maximum level set on the power display on the front panel.
Notice
Press the Power pedal prior to applying the tip of the handpiece to tissue. This
will ensure that the tip is vibrating before load is applied.
68 • Chapter 5 • Operating the CUSA® NXT During Surgery

6. If the surgeon only wishes to irrigate the operating site, press the Fast
Flush Footswitch pedal. Irrigant will flow from the end of the handpiece at
a rate of 50 ml/min.
7. If a problem occurs, see Chapter 7 for troubleshooting guidelines.
8. If blockage occurs in the handpiece during operation, use the supplied
sterilized nylon stylet to clear it. When using the stylet, pass it into the
titanium tip of the handpiece until the blockage is cleared. After clearing
the blockage, wash the tip as described in the following section, "Cleaning
the Handpiece During Surgery" .
Caution
pass the stylet in from the tip end.
9. If for any reason the Console is powered down for a period of less than 30
minutes and then powered up, the Surgery Mode is immediately
accessed, bypassing the normal priming procedure.
Cleaning the Handpiece During Surgery

During intervals of operative use, Integra LifeSciences recommends
immersing the tip of the handpiece momentarily into sterile water or saline.
This will prevent blood and tissue debris from drying on the inner surfaces of
the handpiece and aspiration line and minimize the risk of a blockage in the
aspiration system.
Warnings Relating to the Tips 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 and
require replacement before use.
Warning
CUSA NXT 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 NXT tips at the surgical site can induce heating due
to vibration and acoustic power transmissions into adjacent tissue that may not
be easily visualized due to anatomical constraints.
Thermal management of the surgical site with the aid of the appropriate
irrigation and aspiration settings is essential.
Warning
Avoid excessive lateral loading of CUSA NXT tips. This may result in equipment
damage and/or injury to the patient or surgical personnel.
Customizing the User Settings

On the main screen, press the settings button to save ultrasonic settings and
specify languages for on-screen text.
Note the following settings:
Settings Description
presets Provides functions for saving and restoring power, irrigation, and
aspiration values.
language Provides options for displaying the touch screen content into 5
different languages: English, French, Italian, German, and
Spanish.
Note the presets settings can be customized depending on surgeon’s needs,

while the languages settings are customized prior to shipping.

Saving Customized Ultrasonic Settings
Press the presets button to save customized settings or restore the default
settings.
To save customized settings for subsequent sessions:
1. Adjust the power, irrigation, and aspiration settings to the desired levels.
2. On the main screen, press the settings button and choose the presets
option.
3. On the displayed panel, press the save current set points button. The
system will save the current power, irrigation, and aspiration levels. The
next time the system is turned on, the CUSA NXT System will restore
these values.
To restore the default settings, press presets on the settings panel and
choose restore default set points option. The CUSA NXT System will
restore the factory settings for the power, irrigation, and aspiration levels.
Specifying Languages for On-screen Text

Press the languages button to specify the language of the onscreen text
(English, French, German, Italian, and Spanish).


CHAPTER 6 DISASSEMBLY AND STERILIZATION OF
CUSA® NXT SYSTEM
Dismantling the System After Surgery ........................................................ 73

Cleaning the Handpieces After Surgery ...................................................... 75
Sterilizing Components and Maintaining the Handpieces......................... 77
Maintaining the Touch Screen Monitor ....................................................... 80
Handling and Transporting the System....................................................... 81
Notice
The handpiece and the initially pre-packaged non-sterile tip and flue(s) are
supplied non-sterile and must be disassembled and sterilized before use.
Dismantling the System After Surgery

After an operative procedure, dismantle the system and prepare it for
storage.
1. If the same settings used during the operation may be required for future
use, use the preset feature to save them (see page 70).
2. Remove the handpiece from the operating area and flush it by aspirating
at least 100 ml of isotonic fluid. Note that the residue from the intravenous
fluid container usually provides a convenient source of fluid.
3. Remove the hose clips from the handpiece cable.
4. Disconnect the tubing set from the handpiece.
5. Disconnect the contamination guard tubing from the vacuum port of the
canister.
6. Remove the intravenous fluid container from the tubing set and discard.
7. Remove the irrigation tube from the peristaltic pump, the aspiration tube
from the pinch valve and the aspiration filter from the Console. If using a
disposable liner, remove it from the suction canister and discard together
with the entire tubing set. If using a hard canister, discard it with entire
tubing kit.
Warning
To avoid injury to surgical personnel, keep fingers away from the pump valve
Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 73

Notice
the system.
Notice
Do not re-use the tubing kit as this compromises sterility and may lead to
damage of the Console and/or Service Module.
Notice
Do not remove the contamination guard situated in the receptacle bay at the
front of the Service Module.
8. Turn off the power on the rear panel of the CUSA® NXT Console and
Service Module (if utilized). Remove the main power cord from the
Console or Service Module as appropriate, wipe clean and store in the
rear cupboard of the Service Module (if utilized).
9. Disconnect the Footswitch and wipe clean. If the Footswitch is
contaminated with blood or fluid, it may be cleaned by immersing it in
warm water containing detergent or disinfectant (the port must be kept
dry) and rinsed. Allow the Footswitch to drain after washing and store in
the rear storage area of the Service Module (if utilized).
10. Wipe the Console and the Service Module with a clean cloth dampened
with warm water and a mild detergent, disinfectant or alcohol when
necessary to remove blood or dirt. Lower the irrigation pole by turning the
knurled locking ring counter-clockwise.
Warning
Electric Shock Hazard – Always unplug the CUSA NXT System before cleaning
it.
Warning
Do not allow fluids to enter the Console or Service Module.
11. Remove the handpiece cable from the Console and disconnect from the
handpiece. Wipe the cable with a clean cloth dampened with warm water
and a mild detergent, disinfectant or alcohol when necessary to remove
blood or dirt.
Notice
When dismantling and assembling handpieces of different operating
frequencies (24 kHz or 35 kHz), care should be taken to ensure that the correct
tips are fitted to the correct handle section. This is achieved by following the
color coding, bronze for 24 kHz and gold for 35 kHz. Incorrectly fitted
handpieces will either be non-functional or may not perform as intended.
74 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

Cleaning the Handpieces After Surgery
Disassembling the Handpieces

After surgery and prior to sterilization, disassemble and clean the CUSA®
Selector® handpiece:
1. In a sink or bowl, prepare a cleaning solution containing warm water with
detergent. This is necessary for cleaning the handpiece parts. Consult
hospital policy for approved cleaning materials.
2. Remove and dispose of the clear flue after use, in compliance with the
hospital policy for disposal of contaminated waste.
3. Remove the black shroud and place in the cleaning solution.
4. Lay the handpiece in the appropriate wrench holder with the wrench flat
secured in the holder cut-out.
5. Using the appropriately sized end of the wrench, loosen the tip by turning
it counterclockwise. Unscrew the tip and place it in the cleaning solution.
If the tip is single-use only or shows evidence of damage, discard the tip.

6. Reposition the handle of the handpiece in the holder cut out and using the
same wrench set as before, loosen the angled extension by turning it
counterclockwise.
Notice
7. Detach the angled extension and place it in cleaning solution.

8. Keeping the plug dry, place the handpiece handle and cord into cleaning
solution.
Guidelines for Cleaning the Handpieces

1. Clean all handpiece parts thoroughly using an aspiration port brush (part
# 1523101) to clean the inner channels, pushing it in the direction of
aspiration (i.e. from tip to handle).
2. Rinse all parts in clean water (keeping the plug dry) and dry thoroughly.
3. Clean and rinse the wrench set and add it to the sterilization tray (part #
07289 for the CUSA Selector Handpiece).
4. Place the wrench set in sterilization tray.
5. Place the disassembled handpiece and applicable accessories (reusable
tip, reusable shroud, non-sterile flue, and angled extension) in a
sterilization tray.
6. Sterilize according to hospital policy (see page 77).
Notice
Product damage will result if you do not follow these notices when cleaning the
handpiece:
• Do not immerse the handpiece cable electrical connector in liquid.
• Do not use ultrasonic or automatic washers.
• Do not use chlorinated substances such as bleach solution.
• Do not clean the handpiece with abrasive cleaners or steel wire wool.

Sterilizing Components and Maintaining the Handpieces
Recommended Sterilization Procedures

The handpieces and non-sterile tips and flues must be sterilized before initial
use. Handpieces and reusable components are cleaned and sterilized after
surgery for next use. Before sterilization, disassemble the handpiece and
accessories as described on page 75. Handpieces, reusable tips, and
accessories should be cleaned after surgery before sterilization. Note that
sterilization systems in use at hospitals are chamber specific. As a result,
Integra LifeSciences can only recommend a reference for hospitals to aid the
sterilization parameters set for your hospital system. Integra LifeSciences
has validated the following sterilization cycles for your consideration.
Steam Sterilization
Place the disassembled handpiece and applicable accessories (reusable tip,
reusable shroud, non-sterile flue and extender) into a sterilization tray.
Double-wrap the sterilization tray in suitable sterilization grade paper and
place fresh filters in the filter ports situated in the top and base of the
sterilization tray. Filters must be replaced after each sterilization cycle.
Integra LifeSciences also recommends using tamper resistant locks in
conjunction with the filters for the unwrapped containers. Place these locks
on the handle of the sterilization tray to ensure that the sterility has not been
broken.
Wrapping Minimum Minimum

Cycle Dwell Time
Conditions Temperature Dry Cycle
Double wrapped 134 °C (273 °F) Pre-vacuum cycle 3 10 Minutes

with filters in the lid minutes
and base of
container Pre-vacuum cycle 18
minutes
132 °C (270 °F) Pre-vacuum cycle 4

minutes
Double wrapped 134 °C (273 °F) Pre-vacuum cycle 3 10 minutes

with the lid removed minutes
and filter in the base
of container Pre-vacuum cycle 18
minutes

minutes

Wrapping Minimum Minimum
Cycle Dwell Time
Conditions Temperature Dry Cycle
Unwrapped with 134 °C (273 °F) Pre-vacuum cycle 3 10 minutes

filters in the lid and minutes
base of container
Pre-vacuum cycle 18
minutes

minutes
Unwrapped with 134 °C (273 °F) Pre-vacuum cycle 18 20-30

filters in the lid and minutes minutes
base of container
Cooling Handpieces Before Use

Allow the handpiece to cool completely before use. Note that it is the user’s
responsibility to verify that the handpiece and components are completely dry
prior to setup.
Validations for Steam Sterilization
Integra LifeSciences has validated steam sterilization. The challenge
organism used was > 1 x 106 Bacillus stereothermophilus.
Biological indicators were placed in the areas identified as the most difficult to
sterilize, representing worst case conditions.
The biological indicators were inoculated into Tryptone Soya Broth and
incubated for seven days. The biological indicators produced no growth,
indicating that a Sterility Assurance Level (SAL) of 10-6 was achieved.
Caution
Validation of the steam cycles described have been conducted, however, it is
solely the decision of the hospital to approve the use of these cycles.
Disinfecting the Handpieces

Disinfect the CUSA Selector handpiece in one of the following solutions:
• Glutaraldehyde based solutions such as Cidex® or peracetic acid based
solutions such as Nu-Cidex™. Follow the instructions supplied by the
manufacturer.
• Solutions of Hibicet™ or Hibitane® in water or ethanol. Follow the
instructions supplied by the manufacturer.
Warning
• Disinfecting solutions containing sodium hypochlorite may cause damage to the
metal tip of the handpiece and are not recommended.
• Do not immerse the handpiece cable connector in the disinfecting solution.

Maintaining the Handpieces
In addition to the post-operative care of the CUSA NXT System described on
pages 73 and 75, further maintenance steps recommended by the
manufacturer are as follows:
General Maintenance
At 6 Month Intervals
1. Remove and replace the contamination guard every six months, or when
the filter changes color (part # NXT00005). Remove and replace silicone
hose that connects the suction port on the Service Module to the waste
canisters.
2. Examine all shroud sections and replace if damaged.
3. Examine all cable and electrical connectors for signs of excessive wear
and damage, and replace if damaged.
Contact Integra Service Center for information on replacing parts.
Preventive Maintenance
At 12 Month Intervals
Integra service personnel should undertake preventative maintenance. In
addition to complete cleaning, performance and safety checks on the
Console, Service Module, Footswitch and handpieces should be carried out.
Full details of these checks are available from the manufacturer or supplier.
Contact Integra Service Center for information on returning equipment for
service.
Warning

Service Centers
Service Centers Address
United States Integra NeuroSciences

5965 Pacific Center Blvd.Suite 714
San Diego, CA 92121
Tel: 858-455-1115
Fax: 858-455-8298
E-mail: [email protected]
International Integra NeuroSciences

Halskestrasse 25
Ratingen 40880
Germany
Tel: +49 2102 5535 6150
Fax: +49 2102 942 4872
E-mail: [email protected]
Maintaining the Touch Screen Monitor

Use the following maintenance guidelines to ensure the touch screen
functions optimally:
Safety Guidelines
• To reduce the risk of shock, follow all safety notices and never open the
touch screen monitor case.
• Turn off the system before cleaning.
• The slots located on the sides and top of the touch screen are for
ventilation. Do not block or insert anything inside the ventilation slots.
• Keep the touch screen dry at all times. Do not pour liquid into or onto the
touch screen. If the touch screen becomes wet, contact technical
support. Do not attempt to repair it yourself.
Cleaning Guidelines
• To clean the touch screen, use window/glass cleaner, eyeglass cleaner,
or a quaternary ammonia disinfectant. Put the cleaner on the rag and
wipe the touch screen. Never apply cleaner directly to the touch screen.
• Do not use alcohol (methyl, ethyl, or isopropyl) or any strong solvent. Do
not use thinner or benzene, abrasive cleaners, or compressed air.
• Do not wipe the touch screen with either a cloth or sponge that could
scratch the surface.
Cleaning the Display Cabinet

Use a cloth that is lightly dampened with a mild detergent.

Handling and Transporting the System
If you need to move/relocate the CUSA NXT System within the environment
of the Healthcare Facility, note the guidelines below.
The CUSA NXT 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.
Console with Service Module

Before moving the system:
• Unplug the power cord from the wall receptacle and place the power cord
in the storage compartment at the rear of the Service Module.
• 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
top of the Console.
• Disconnect the Footswitch and place the Footswitch in the storage
compartment at the rear of the Service Module.
When moving the system:
• Push the system using the handle; don’t pull it.
• Do not run whilst pushing the system.
• Use a lift to move the system between floors of a building. Never use a
stairwell.
• Do not attempt to lift the system.
To move the system up or down a ramp, use two or more people.
Console without Service Module

Before moving the Console:
• Unplug the power cord from the wall receptacle. Disconnect the power
cord from 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
top of the Console.
• Disconnect the footswitch.
When moving the Console (in the immediate environment):
• Lift the Console using the side grips.

• Place the Console on a solid surface. The surface must be flat, non-slip
and free from obstruction.
Shipping Instructions
Clean and sterilize the equipment as per the instructions in Chapter 6. If the
equipment is being transported from a hospital, ensure that a Sterilization
Certificate is completed and a copy is included within the package.
Handpieces
Place handpiece in a plastic bag and surround with foam/bubble wrap. Pack
in a stout cardboard box adding sufficient soft packaging to cushion and
protect the contents.
Consoles, Modules and Footswitches

It is recommended that flight cases be used on all occasions for air
transportation of the NXT systems. During Service Module handling pallets
should also be used. Flight cases can be purchased upon request from
Integra.
Notice
In instances where flight cases are not used please package as described
for the Handpieces making sure that the contents will be well protected
against dropping and manhandling. It is strongly advised that the original
cardboard packaging is only used once for re-packing.
If you do not have suitable packaging please contact your Integra

representative.

®
CHAPTER 7 TROUBLESHOOTING THE CUSA NXT
SYSTEM
About the Troubleshooting Process............................................................ 83

Problems Powering the System On and Off ............................................... 83
Responding to Alarms .................................................................................. 84
Troubleshooting Aspiration Problems ........................................................ 85
Troubleshooting Irrigation Problems .......................................................... 86
Troubleshooting Ultrasonic Power Problems............................................. 87
About the Troubleshooting Process

If you encounter problems when using the CUSA® NXT System, first verify
that the system is set up correctly. For complete setup instructions, see
Chapter 4 in this manual.
About this Chapter

The following sections provide guidelines for troubleshooting and resolving
specific problems. If the problems persist, contact technical support for
service.
Problems Powering the System On and Off

If the system does not start properly, try rebooting the system:
1. On the back of the Console, press and hold the power button for 6
seconds.
2. Unplug the unit from the wall and then plug it back in.
3. Power up the unit normally.
Chapter 7 • Troubleshooting the CUSA® NXT System • 83

Responding to Alarms
All alarms on the CUSA NXT are low-priority, technical alarms; operator
awareness is required.
Symbol Alarm Causes Recommendations
Tubing not attached to suction Attach the tubing to the suction

Aspiration
canister. canister.
• Tighten the tip.

Power Improper tip assembly. • Reconnect the handpiece.
• Replace the tip.

Bad tip.
• Reconnect the handpiece.
Connect the handpiece to the

Handpiece Handpiece not connected. appropriate port:
• Red 24 kHz
• Green 35 kHz
• Black 24 kHz Microsurgical
Two or more handpieces are

Disconnect extra handpieces.
connected.
Connect the Footswitch to the

Footswitch Footswitch not connected.
rear of Console.
More than one Footswitch pedal

Release one Footswitch pedal.
is pressed.
Footswitch pedal is pressed

while connecting components to Release the Footswitch pedal.
the Console.
Restart the system. If the alarm

General System General system fault. persists, contact technical
support.
Notice
If you press the yellow symbol, the touch screen monitor will display error
and problem resolution information.
84 • Chapter 7 • Troubleshooting the CUSA® NXT System

Troubleshooting Aspiration Problems
Problem Causes Recommendations
Insufficient Aspiration Service Module is unplugged. Plug in the Service Module.
Tubing is routed incorrectly. See the diagram on the Console for

correct routing. Ensure that the filter is
fully inserted.
Tubing is not connected to the Connect the tubing to the suction source.
suction source. See page 59.
Aspiration level displayed on the Set aspiration level to appropriate level.

touch screen is too low.
Tubing is blocked or occluded. Unblock tubing with the stylet or saline

flush.
Pinch valve not working correctly. Contact technical support.
Suction canister is full. Remove the suction canister and replace

with a new one.
Suction canister is cracked. Remove the suction canister and replace

with a new one.
Contamination filter is clogged. Check the contamination filter on both the

tubing and the Service Module for clogs. If
a clog exists, replace the appropriate filter.
Aspiration tubing is pinched or Remove the pinch or kink from the tubing.
kinked.
Hole in the aspiration tubing. Inspect the aspiration tubing for holes. If
holes are found, replace the tubing.
Liquid permeates the Footswitch. Replace the Footswitch with a new one.
Excessive Aspiration Tubing between handpiece and Unblock the tubing with the stylet or saline
Console is blocked or occluded. flush.
Handpiece is blocked. Unblock the handpiece with the stylet.
Aspiration is set too high. Reduce the aspiration level setting.
Aspiration pinch valve stays open. Contact technical support.
Aspiration set point level cannot Contact technical support.

be reduced.

Troubleshooting Irrigation Problems
Excessive Irrigation Incorrect rate set. Set the appropriate rate (normally
between 2 and 6 ml/min).
Tubing is not routed correctly. See the diagram on the Console for the
correct routing.
Irrigation pump is not fully closed. Close the irrigation pump.
Broken Fast Flush pedal on the Replace the Footswitch with a new one.
Footswitch.
Irrigation pump is running at an Contact technical support.

excessive speed.
Insufficient Irrigation Incorrect rate set. Set the appropriate rate (normally
between 2 and 6 ml/min).
Footswitch is unplugged. Plug in the Footswitch.
IV spike is not inserted into the bag. Insert the spike into the IV bag.
IV bag is empty. Replace the IV bag with a new one.
Tubing is not connected to the Reconnect the tubing. See page 62.
irrigation pump correctly.
Tubing is not primed. Prime the tubing. See page 63.
Irrigation tubing is blocked. Inspect the tubing for blockage.
Irrigation tubing is pinched or kinked. Remove the pinch or kink from the
tubing.
Hole in the irrigation tubing. Inspect the irrigation tubing for holes. If
holes are found, replace the tubing.
Broken Fast Flush pedal on Replace the Footswitch with a new one.
Footswitch.
Pump does not rotate when pressing Contact technical support.

the Footswitch.

Troubleshooting Ultrasonic Power Problems
Insufficient Power Footswitch is unplugged. Plug in the Footswitch.
Power level is not set appropriately. Set the power level appropriately
(normally set between 70% and 100%).
Improper tip assembly. • Detach the tip and reassemble the

handpiece; or
• Detach the tip and replace it with a new
one.
The Footswitch power pedal is broken; Replace the Footswitch with a new one.
the pedal will not turn on.
Excessive Power The Footswitch power pedal is broken; Replace the Footswitch with a new one.
the pedal will not turn off.
Handpiece Failure Handpiece is overheating. Insufficient aspiration. See page 85 for

troubleshooting tips.
No power to handpiece. Try the following:

• Verify that the handpiece is plugged into
the correct port.
• Replace the handpiece with a new one.
If the problems persists, contact
technical support.
Tip Failure Tip overheating. Insufficient irrigation. See page 86 for

troubleshooting tips.
No Power to System System is not turned on. Turn on the system.
Service Module is not plugged in. Plug in the Service Module to the
Console.


APPENDIX A TECHNICAL SPECIFICATIONS
Specifications for the CUSA® NXT System................................................. 93

Electrical Safety ............................................................................................. 91
Standards and IEC Classifications .............................................................. 93
Manufacturer’s Declaration Table ................................................................ 94
Specifications for the CUSA® NXT System
Console Specifications
Parameter Specification
Height 31.8 cm (12.5 in)
Width 45.7 cm (18 in)
Depth 58.9 cm (23.2 in)
Weight 20.9 kg (46 lbs)
Aspiration 15 to 100% of available vacuum
Irrigation 2 to 20 ml/min (accuracy +/- 20% of reading)
Service Module Specifications
Height 87.6 cm (34.5 in)
Width 50.3 cm (19.8 in)
Depth 76.6 cm (28.6 in)
Weight 45.4 kg (100 lbs)
Vacuum 635 mmHg
Vacuum Capacity 75 L/min free air minimum
Appendix A • Technical Specifications • 89

Footswitch Specifications
Height 6 cm (2.4 in)
Width 19.5 cm (7.7 in)
Depth 22 cm (8.7 in)
Weight 2 kg (4.4 lbs)
Length 5.81 m (19 ft)
Input Power Source Specifications
Power Requirements 115-230 V~, 50-60 Hz (Console)

115/230 V~, 50-60 Hz/50 Hz (Service
Module)
Power Consumption 250 VA Console

700 VA Console with Service Module
Environmental Conditions
Operating Temperature Range 10º to 35ºC
Storage Temperature Range - 20º to 60ºC
Operating Humidity Range 30% to 75% RH
Storage Humidity Range 25% to 85% RH
Operating Atmospheric Pressure Range 700 to 1100 hPa
Storage Atmospheric Pressure Range 500 to 1100 hPa
Operating Altitude Up to 3000 meters
90 • Appendix A • Technical Specifications

Warning
Operating the CUSA NXT outside of the specified environmental conditions
may result in injury to the patient and/or surgical personnel, or cause damage to
the equipment which may result in a delay in patient treatment.
Low Frequency Leakage
Parameter Leakage
Touch Current < 100 A

Patient Leakage Current < 10 A
Power Cord Specifications
AC Power Supply Power Cord Part # Destination
100 - 120 volts NXT80001 USA/Canada
200 - 240 volts NXT80003/ UK/Europe

NXT80002
Replace fuses with only those of the same type and rating. For details, see
labeling on the rear panel.
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 2011on the restriction of the use of certain hazardous substances in
electrical and electronic equipment (recast).
Electrical Safety
The CUSA NXT System requires a single grounded electrical outlet providing
power at 115 -230 V~, 50-60 Hz (Console),115/230 V~, 50-60 Hz/50 Hz
(Service Module) . The Console operates on any voltage between 115 V and
230V. The Service Module has two voltage settings: 115 V and 230 V. The

voltage setting switch is located inside the rear compartment under the
access panel. The access panel displays two stamps, 115 V and 230 V, at
opposite corners of the access panel. The position of the access panel
determines what voltage the Service Module is set at. The maximum current
drawn is 2.5 amps at 240 V and 5 amps at 100 V. The removable power cord
supplied with the system provides the power.
Correct grounding of the CUSA NXT Console is essential for safe operation.
The Console is grounded via the power cord; verify that this cord is
connected to a properly grounded power receptacle of appropriate rating.
Only use the power cord supplied with the system since these cords vary
according to destination. An external ground point is also located on the rear
panel (see page 35).
Warning

Standards and IEC Classifications
Quality Systems
The CUSA NXT System is manufactured by Integra LifeSciences
Corporation. Integra LifeSciences Corporation operates a quality system that
complies with ISO 13485, CMDCAS.
International Bodies
The CUSA NXT System has been designed, constructed, and approved to
the requirements of the following international bodies:
• International Electrotechnical Commission (IEC)
• Canadian Standards Association (CSA)
Safety Standards
The CUSA NXT System has been independently tested and complies with
the following standards:
• CAN/CSA-C22.2 NO.60601-1-08 Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance
• IEC 60601-1:2005 Medical Electrical Equipment: General Requirements
for Basic Safety and Essential Performance
• IEC 60601-1-8:2006 Medical Electrical Equipment Part 1-8: General
Requirements for Basic Safety and Essential Performance. Collateral
Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
• IEC 60601-1-2:2007 Medical electrical equipment: General Requirements
for Basic Safety and Essential Performance. Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
Note that the Footswitch is additionally rated IPX8 for moisture resistance.

Manufacturer’s Declaration Table
Notice
The CUSA NXT System should not be used adjacent to or stacked with
equipment other than the equipment specified in the CUSA NXT System
Operator’s Manual. If adjacent or stacked use is necessary, the CUSA NXT
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 NXT System Operator’s Manual may result in increased
emissions or decreased immunity of the CUSA NXT System.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The CUSA NXT System is intended for use in the electromagnetic environment specified below. The customer or the
user of the CUSA NXT System should assure that it is being used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1 The CUSA NXT System uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions CISPR 11 Class A The CUSA NXT System is suitable for use in all
establishments other than domestic and those
Harmonic emissions IEC 61000-3-2 Class A
directly connected to the public low-voltage
power supply network that supplies buildings
Voltage fluctuations/flicker emissions IEC Complies with
used for domestic purposes.
61000-3-3 Standard
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

Immunity Test IEC 60601 test level Compliance Electromagnetic environment - guidance
Electrostatic ±6 kV contact Complies with Floors should be wood, concrete or ceramic

discharge (ESD) ±8 kV air Standard tile. If floors are covered with synthetic
IEC 61000-4-2 material, the relative humidity should be at
least 30%.
Electrical fast ±2 kV for power lines Complies with Mains power quality should be that of a typical
transient/burst IEC ±1 kV for input/output lines Standard commercial or hospital environment.
61000-4-4
Surge IEC ±1 kV differential mode Complies with Mains power quality should be that of a typical
61000-4-5 ±2 kV common mode Standard commercial or hospital environment.

Voltage dips, short • <5 % U r (>95% dip in Complies with Mains power quality should be that of a typical
interruptions and U r ) for 0.5 cycle Standard commercial or hospital environment. If the user
voltage variations of the CUSA NXT System requires continued
• 40% U r (60% dip in
or power supply operation during power mains interruptions, it
U r ) for 5 cycles
input lines IEC is recommended that the CUSA NXT System
61000-4-11 • 70% UT (30% dip in be powered from an uninterruptible power
U r ) for 25 cycles supply or a battery.
• <5% U r (>95% dip in
U r ) for 5 seconds
Power frequency 3 A/m / 50 Hz magnetic Complies with Power frequency magnetic fields should be at
(50/60 Hz) field Standard levels characteristic of a typical location in a
magnetic field IEC typical commercial or hospital environ-
61000-4-8 ment.
Notice: Ur is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test IEC 60601 test level Compliance Electromagnetic environment - guidance
Portable and mobile RF communications

equipment should be used no closer to any
part of the CUSA NXT 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
80 MHz to 2,5 GHz
of the 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
a
survey , should be less than the compliance
b
level in each frequency range .
Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 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 NXT System is used exceeds the
applicable RF compliance level above, the CUSA NXT 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 NXT System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between

portable and mobile RF communications equipment and the CUSA NXT System
The CUSA NXT System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the CUSA NXT System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the CUSA NXT 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.


APPENDIX B WARRANTY
Integra Warranty for the CUSA® NXT Ultrasonic Surgical Aspirator
1. Warranty
1. 1 Duration. The Warranty is provided for one year from the date that the
equipment is invoiced to the customer.
1. 2 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 with the
Specifications defined in the CUSA NXT Ultrasonic Surgical Aspirator
Operator's Manual, as such Operator's Manual may be modified by
Integra from time to time.
1. 3 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, tubing, and accessories
other than those manufactured by Integra LifeSciences;
(ii). defects arising out of materials or parts provided, modified or
designed by Customer;
(iii). defects emanating from Customer's improper or negligent
installation, storage or use of the Equipment or any component
thereof, including but not limited to operating the Equipment not in
accordance with instructions provided in the Operator's Manual;
(iv). defects arising from improper or negligent cleaning or sterilization
methods or improper maintenance of the Equipment;
(v). defects resulting from repairs or service of the Equipment
provided other than by Integra or its authorized representatives;
(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." Customer shall be responsible to pay
Integra's then-standard charges for any out-of-warranty repairs
Appendix B • Warranty • 99
performed by Integra. Integra's sole obligation for Equipment defects
and failures of performance shall be to make all necessary adjustments
and repairs in accordance with this Warranty.
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 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. 1.1Consoles and Service Modules. Integra shall, if possible, perform
on-site repair of Consoles and service module or replace a
Console and service module by a new or refurbished Console and
service module (at the discretion of Integra), as the case may be,
and where not possible Integra shall arrange and pay to ship the
affected Equipment to the designated repair facility, and shall
repair the affected Equipment.
3. 1.2Handpieces. Integra shall replace any defective handpieces
covered by the Warranty by a new or refurbished handpiece (at
the discretion of Integra) that shall carry the same 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
("Specifications"). 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.
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.
100 • Appendix B • Warranty

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 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,
EXPRESSED 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,
DIAGNOSES, 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 AFFILIATES, ASSIGNEES OR
SERVICE AGENTS BE LIABLE FOR LOSS OF USE, REVENUE OR
PROFIT OR ANY OTHER DIRECT, 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 AFFILIATES, ASSIGNEES OR SERVICE AGENTS
HEREUNDER OR PURSUANT HERETO IN EXCESS OF THE
AMOUNTS PAID BY CUSTOMER TO INTEGRA DURING THE
WARRANTY PERIOD.
5. 2 Customer agrees that, notwithstanding the technical assistance
provided pursuant to the Warranty by Integra or its representatives,
Customer shall be fully 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 AFFILIATES, ASSIGNEES OR
SERVICE AGENTS, FOR PURPOSES OF THE PARTICULAR
TREATMENT THAT CUSTOMER UNDERTAKES TO PERFORM FOR
THIRD PARTIES. Moreover, Customer shall not make any claim
against Integra or any of its affiliates, assignees or representatives 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
undertaken by Customer.
5. 3 Force Majeure. Notwithstanding anything to the contrary herein
contained, if the performance of the Warranty by Integra or Customer or
any obligation of Integra 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,
Appendix B • Warranty • 101

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 or Customer, then and in that event Integra or
Customer, as the case may be, shall promptly notify the other party
hereto of the resulting difficulties therefrom, and any of the foregoing
events shall excuse any performance required under the Warranty.
102 • Appendix B • Warranty

INDEX
Numerics color codes, handpieces 36

24 kHz handpieces compliance standards 93
list of neurosurgical 50–54 components, list of 20–26
list of standard 48–49 Console
35 kHz handpieces cleaning the 74
list of neurosurgical 53 functionality of 33–38
list of standard 49 label symbols 10–15
maintaining the touch screen 80
A technical specs for 89
air outlet, fan 35 contamination guard 22, 59, 79
alarms cords, power
definitions of 39 Console with Service Module 6, 46
responding to (see also troubleshooting prob- electrical safety 92
lems) 84 Footswitch 21
testing the alarm tone 65 customizing settings 71
tone 40
aspiration D
adjusting levels of 43 damages, shipping 17
alarm symbol 39 declaration tables, manufacturers 94
control port for filter 34 disassembly, handpiece 75
displaying current levels 43 see also assembly, handpiece
troubleshooting problems with 85 disinfecting handpieces 78
assembly, handpiece 56–58
see also disassembly, handpiece E
electrical safety 91
B electromagnetic emissions and immunity 94
backup handpieces, recommendations for 28 emissions, electromagnetic 94
Bemis Hi-Flow waste canister 22 English, changing language to 71
blocked handpieces, clearing 29 environmental conditions 90
blue Footswitch pedal (see "Fast Flush" Footswitch errors, troubleshooting 83–87
pedal) explosion and fire hazards 31
Bone Tips 50, 51
buttons, menu 44 F
fan, cooling 35
C Fast Flush Footswitch pedal (see also "Power
canisters, waste 22 Footswitch pedal") 38
Cautions, list of 3 fire and explosion hazards 31
centers, service 80 flues, handpiece 47
classification symbols 10–15 Footswitch pedals
classifications, standards and IEC 93 about the 21
cleaning cleaning the 74
Console 74 port for 35
Footswitch pedals 74 technical specs for 90
handpieces after surgery 75–76 troubleshooting alarms for 84
Service Modules 74 using the 36–38
touch screen monitors 80 freeze, responding to a system 83
clinical use French, changing system language to 71
laparoscopic handpieces 49
clock symbol, about the 43
Index • 103
G languages, changing onscreen 71
general alarms, responding to 84 laparoscopic handpieces 49
German, changing language to 71 Latex free components 31
grounding point, Console’s 35 leakage, low frequency 91
grounding, electrical 91 left Footswitch pedal (see “Power Footswitch pedal")
levels, controlling ultrasonic 41–44
H
handpieces, types of M
24 kHz mains inlet (see power inlet)
list of neurosurgical 50–54 maintenance
list of standard 48–49 handpieces 79
35 kHz touch screen monitor 80
list of neurosurgical 53 menu buttons on Console 44
list of standard 49 Microsurgical handpiece (24 kHz) 54
handpieces, using the monitor (see touch screen monitor)
about the functionality 47 multiple handpieces, sterilizing 28
about the tips 25
activating 38 N
assembling the 56–58 neurosurgical handpieces, list of 50–53
cleaning after surgery 75–76 noise, controlling console 35
clearing blocked 29
connecting to Console 36 O
disassembling the 75 on/off button 35
priming the 63–65 Online help 2
safety precautions for 27 online help, accessing 2
sterilization 77–79 operating the system, instructions for 67–69
troubleshooting alarms for 84 operator’s manual, reviewing the 2
help button 44 orange Footswitch pedal (see "Power Footswitch
help files, accessing 2 pedal")
Hi-Flow canister, Bemis 22
P
I pedals, using Footswitch 36
icons piezoelectric transducer, handpiece 47
alarm 84 pinch valve, Console 34
Console label 10–15 ports
status 39 aspiration control 34
IEC and UL approvals 93 Footswitch 35
immunity, electromagnetic 94 handpiece 34, 36
indications for use suction, Service Module 45
laparoscopic handpieces 49 power cords
information panel 43 Console with Service Module 6, 46
inspections, shipment 17 technical specifications for 91
installation, system 18 Power Footswitch pedal (see also Fast Flush
irrigation Footswitch pedal) 37
adjusting levels 42 power, ultrasonic
Console pump 34 adjusting levels for 41
troubleshooting problems 86 technical specifications for sources of 90
using the Fast Flush pedal 38 troubleshooting problems 84, 87
Italian, changing language to 71 verifying accumulated time 44
IV bags powering on/off
preparing for surgery 60 button for 35
weight support 34 reboot and shut down 83
pre-sets, saving and restoring 71
L priming handpieces 63–65
labels, Console 10–15 pump, irrigation 34
104 • Index
Q preparing 59
quality standards, list of 93 requirements for 22
support, technical 80
R surgery, using the system for 67–69
reboot and shut down system 83 symbols
RECEPTAL waste canister 22 alarm 84
repairs, requirements for 31 Console label 10–15
restoring and saving settings 71 status 39
right Footswitch pedal (see "Fast Flush" Footswitch system error alarm 84
pedal)
T
S technical support, contacting 80
SaberTip handpiece 50 text, changing languages 71
safety information time, determining accumulated 43
indications for use 1 tips, handpiece
intended users 2 ordering sterile and non-sterile 25
warnings, cautions and notices, full list of 3 picture of 47
safety precautions touch screen monitor
electrical 91 maintaining the 80
summary of 26–31 safety guidelines for 80
touch screen monitor 80 using the 38–44
saving and restoring settings 71 training, customer 18
scales, adjusting the ultrasonic 41–44 transducer, piezoelectric 47
screen (see touch screen monitor) Transporting, the system 81
service centers 80 troubleshooting problems 83–87
Service Modules tubing kits
about the ??–6, 44–46 about 24
cleaning the 74 connecting to Console 62
initial setup with Console 19 preparing 60–61
technical specifications for 89 tubing pathway, symbols for 14
servicing turning off system 83
contacting Integra 80
requirements for 31 U
service centers 80 ultrasonic power
settings button 44 controlling 41–44
shroud, handpiece 47 technical specifications for 90
shut down and reboot, system 83 troubleshooting problems with 87
Spanish, changing language to 71 unpacking the system 17
spanner (see wrench sets, handpiece) user’s manual, reviewing the 2
specifications, technical 89–91
standard handpieces V
list of 24 kHz 48–49 vacuum source
list of 35 kHz 49 determining current level of 43
standards, list of quality 93 preparing 59
sterile and non-sterile tubing kits 25 requirements for
sterilization handpiece 77–78 volume control knob 35
sterilization procedures, handpiece
backup handpieces 28 W
storage compartment, Footswitch and power cord 45 Warnings, list of 3
stylet, clearing blocked handpieces 29 warranty, product 99–102
suction ports for tubing 45 waste canisters
suction source requirements for 22
determining current vacuum level of 43 wrench sets, handpiece 23–26
suction sources
see also Service Modules
Index • 105
106 • Index

Integra® CUSA® NXT: Ultrasonic Surgical Aspirator System

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Integra®

CUSA® NXT Operator’s Manual

Integra® CUSA® NXT OPERATOR’S MANUAL

Ultrasonic Surgical Aspirator System

Integra® CUSA® NXT Operator’s Manual

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

USA and Canada: 800.997.4868 609.936.5400 (Outside USA)

0086 © 2018 Integra LifeSciences Corporation. All Rights Reserved.

Integra LifeSciences (Ireland) Limited.

Chapter 1: Patient and Operating Room Safety

Chapter 2: CUSA® NXT System Setup and Components

Chapter 3: Using the Console, Service Module, and Handpieces

Chapter 4: Preparing the CUSA® NXT System for Surgery

Chapter 5: Operating the CUSA® NXT System During Surgery

Chapter 6: Disassembly and Sterilization of CUSA® NXT System

Chapter 7: Troubleshooting the CUSA® NXT System

Appendix A: Technical Specifications

Index .............................................................................................................................. 103

System Overview ............................................................................................. 1

Using this System in Ultrasonic Surgery

Chapter 1 • Patient and Operating Room Safety • 1

Reviewing the Operator’s Manual

2 • Chapter 1 • Patient and Operating Room Safety

Warnings, Cautions and Notices

Patient and Operating Room Safety

The Console is only to be used in a hospital environment and by qualified

CUSA NXT System Setup and Components

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

Chapter 1 • Patient and Operating Room Safety • 3

Risk of explosion. Do not use in the presence of flammable anaesthetic gases

• Electrical shock hazard. Do not remove cover.

Use of the handpieces in a damaged condition can result in an electric shock

4 • Chapter 1 • Patient and Operating Room Safety

Do not use dry air sterilization methods involving temperatures in excess of

Using the Console, Service Module, and Handpieces

Chapter 1 • Patient and Operating Room Safety • 5

Only the Console is shipped with a power cord. If a Service Module is

Preparing the CUSA NXT System for Surgery

Using the incorrect wrench set to assemble/disassemble the handpiece may

Failure to center the shroud may cause the handpiece to overheat.

6 • Chapter 1 • Patient and Operating Room Safety

Chapter 1 • Patient and Operating Room Safety • 7

Disassembly and Sterilization of CUSA NXT System

8 • Chapter 1 • Patient and Operating Room Safety

Do not allow fluids to enter the Console or Service Module.

When dismantling and assembling handpieces of different operating

If you are using either a straight or laparoscopic handpiece, the angled

Use of System in MRI Environments

Chapter 1 • Patient and Operating Room Safety • 9

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

Operating the CUSA NXT outside of the specified environmental conditions

Classification and System Symbols

Warning: When you connect the handpiece to the Console,

Warning: Dangerous voltage.

Follow instructions for use

10 • Chapter 1 • Patient and Operating Room Safety

Do not insert fingers. Pinch point can cause injury.

While the Console is connected to the Service Module, do

Protective Earth (ground)