Integra CUSA NXT Operator's Manual

Integra®

CUSA® NXT Operator’s Manual

Integra® CUSA® NXT

Ultrasonic Surgical Aspirator System

OPERATOR’S MANUAL

0877085 -1
72904051, Issue E

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

n

311 Enterprise Drive, Plainsboro, NJ 08536

USA and Canada: 800.997.4868

n

609.936.5400 (Outside USA)

888.980.7742 (Fax)

integralife.com

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

Integra® CUSA® NXT Operator’s Manual

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:

© 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

Caution

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

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i

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

ii

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

iii

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

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Chapter 1 • Patient and Operating Room Safety • 1

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.

Contraindications

This device is not indicated for and should not be used for the removal of
uterine fibroids.

Warning

No modification of this equipment is allowed.

2 • Chapter 1 • Patient and Operating Room Safety

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.

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:

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.

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.

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.

Chapter 1 • Patient and Operating Room Safety • 3

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

CUSA NXT System Setup and Components

Warning

No modification of this equipment is allowed.

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.

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.

4 • Chapter 1 • Patient and Operating Room Safety

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.

Warning

Chapter 1 • Patient and Operating Room Safety • 5

Using the Console, Service Module, and Handpieces

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.

Caution

Warning

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

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.

6 • Chapter 1 • Patient and Operating Room Safety

Preparing the CUSA NXT System for Surgery

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.

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.

Chapter 1 • Patient and Operating Room Safety • 7

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.

Warning

8 • Chapter 1 • Patient and Operating Room Safety

Operating the CUSA NXT System During Surgery

Disassembly and Sterilization of CUSA NXT System

Warning

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

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.

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.

Caution

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

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 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.

Warning

To avoid injury to surgical personnel, keep fingers away from the pump rollers.

Chapter 1 • Patient and Operating Room Safety • 9

Use of System in MRI Environments

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

Do not remove the aspiration filter from the designated port prior to powering off
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.

If you are using either a straight or laparoscopic handpiece, the angled
extension is not required.

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.

Warning

Warning

The CUSA NXT System cannot be used in an MRI (Magnetic Resonance
Imaging) environment.

10 • Chapter 1 • Patient and Operating Room Safety

Troubleshooting the CUSA NXT System

Technical Specifications

Classification and System Symbols

The following symbols appear on the CUSA NXT System:

Notice

If you press the yellow symbol, the touch screen monitor will display error and
problem resolution information.

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).

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

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.

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

Chapter 1 • Patient and Operating Room Safety • 11

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
emitted by the Console.

Equipotential point

Alternating current

"On" power

"Off" power

Symbol Description

VOLUME

12 • Chapter 1 • Patient and Operating Room Safety

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

Chapter 1 • Patient and Operating Room Safety • 13

Catalogue Number

Serial Number

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

SN

14 • Chapter 1 • Patient and Operating Room Safety

Tubing Pathway Symbols

The following symbols define the tubing pathways:

Non-Sterile

Caution, consult accompanying documents

Not manufactured with dry or natural rubber latex

Keep Dry

Do not re-use

Symbol Description

Symbol Description

IV bag; direction of irrigation tubing towards to
peristaltic pump.

Irrigation; above peristaltic pump.

Chapter 1 • Patient and Operating Room Safety • 15

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.

Symbol Description

16 • Chapter 1 • Patient and Operating Room Safety

Footswitch Symbols

The following symbols appear on the footswitch:

Symbol Description

Power pedal

Fast Flush pedal

Chapter 2 • CUSA® NXT System Setup and Components • 17

CHAPTER 2 CUSA® NXT SYSTEM SETUP AND

C

OMPONENTS

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.

18 • Chapter 2 • CUSA® NXT System Setup and Components

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.

Chapter 2 • CUSA® NXT System Setup and Components • 19

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

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.

1

2

3

4

20 • Chapter 2 • CUSA® NXT System Setup and Components

List of CUSA NXT Components

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

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.

Console

Service Module

Chapter 2 • CUSA® NXT System Setup and Components • 21

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).

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).

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

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.

Power pedal

Fast Flush pedal

22 • Chapter 2 • CUSA® NXT System Setup and Components

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.

Warning

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

Chapter 2 • CUSA® NXT System Setup and Components • 23

About the Handpieces and Wrench Sets

Handpieces

The CUSA NXT Console supports a range of handpieces:

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.

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.

35 kHz Neurosurgery Handpiece

24 • Chapter 2 • CUSA® NXT System Setup and Components

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:

About the Tubing Kits

The CUSA NXT System requires a supply of sterile tubing kits. Sterile tubing
kits have a three year shelf life.

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

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.

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

Chapter 2 • CUSA® NXT System Setup and Components • 25

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:

(*These sterile tips have a three year shelf life.)

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

contains one tip and one flue)

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

contains one tip and one flue)

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)

26 • Chapter 2 • CUSA® NXT System Setup and Components

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:

For Standard Handpieces

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

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)

Chapter 2 • CUSA® NXT System Setup and Components • 27

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

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

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

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

28 • Chapter 2 • CUSA® NXT System Setup and Components

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).

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.

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.

Chapter 2 • CUSA® NXT System Setup and Components • 29

Tightening the Handpieces with the Wrench Kits

Clearing Blocked Handpieces

Inspecting Handpiece Tips for Damage

Priming the Handpieces

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.

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.

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.

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.

30 • Chapter 2 • CUSA® NXT System Setup and Components

Components for Single Use Only

The CUSA Selector tubing kit is supplied sterile for single use only. All flues
are for single use only.

Notice

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

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.

Chapter 2 • CUSA® NXT System Setup and Components • 31

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

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.

Warning

Do not use in the presence of flammable anaesthetic gases or other volatile
solvents.

32 • Chapter 2 • CUSA® NXT System Setup and Components

This page is intentionally left blank.

Chapter 3 • Using the Console, Service Module, and Handpieces • 33

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.

34 • Chapter 3 • Using the Console, Service Module, and Handpieces

About the Left Console Panel

The following table describes the components and connection points on the
left side of the Console.

1

3

4

5

2

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.

Chapter 3 • Using the Console, Service Module, and Handpieces • 35

About the Rear Console Panel

The following table describes the components and connection points on the
rear side of the Console:

1

2

3

4

5

6

Component Description

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
Port

The port designated for the Footswitch plug.

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.

36 • Chapter 3 • Using the Console, Service Module, and Handpieces

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.

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.

Note the following color codes for each handpiece type:

For instructions on assembling the handpiece, see page 56.

Using the Footswitch Pedals

The Footswitch contains two pedals:

•Power (left, orange)

Warni ng

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

Color Panel Handpiece Type

Red Left 24 kHz

Green Front 35 kHz

Black Front 24 kHz MicroSurgical

35 kHz Handpiece

24 kHz MicroSurgical
Handpiece

Chapter 3 • Using the Console, Service Module, and Handpieces • 37

•Fast Flush (right, blue).

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.

Power

Fast Flush pedal

pedal

38 • Chapter 3 • Using the Console, Service Module, and Handpieces

Activating the Handpiece

To activate the handpiece, press the Power pedal for at least 2 seconds.

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.

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.

1

2

3

4

Chapter 3 • Using the Console, Service Module, and Handpieces • 39

This touch screen provides the following tools:

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.

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).

Symbol

Normal
Status

Alarm Indicator (When Yellow)

Alarm
Classification

Alarm
Priority

Aspiration

Signifies an error in the aspiration
process.

Technical Low

Power

Signifies an error in the ultrasonic
generator.

Technical Low

Footswitch

Signifies a fault in the Footswitch or
associated wiring.

Technical Low

Handpiece

Signifies that a handpiece is not
connected.

Technical Low

General

Signifies an error in the electronics or
power supplies.

Technical Low

40 • Chapter 3 • Using the Console, Service Module, and Handpieces

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.

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.

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.

Notice

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.

Chapter 3 • Using the Console, Service Module, and Handpieces • 41

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.

42 • Chapter 3 • Using the Console, Service Module, and Handpieces

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.

Chapter 3 • Using the Console, Service Module, and Handpieces • 43

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%.

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:

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.

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.

44 • Chapter 3 • Using the Console, Service Module, and Handpieces

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:

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.

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).

Front Rear

1

2

3

4

5

6

7

8

Chapter 3 • Using the Console, Service Module, and Handpieces • 45

The Service Module contains the following components:

Component Description

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
Power Cord

The enclosure behind the rear door of the Service Module that
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.

46 • Chapter 3 • Using the Console, Service Module, and Handpieces

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

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.

Service Module

Console

Chapter 3 • Using the Console, Service Module, and Handpieces • 47

About the Handpiece Functionality

Each CUSA® Selector® handpiece contains the following components:

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.

3

4

2

5

1

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
(Internal)

Generates negligible heat and requires no external cooling system. Each
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.



48 • Chapter 3 • Using the Console, Service Module, and Handpieces

List of Standard Handpieces

24 kHz Straight Handpiece (part # 1523000M1)

24 kHz Angled Handpiece (part # 1523000M2)

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

Part # Description Picture

-- Transducer assembly

1523015 Extended Fine Tip,

non-sterile, each 1

1523042 Flue (disposable),

non-sterile, single use,
box of 20

1523049 Angled shroud, each 1

1523033 Angled extension, each

1

1523035 Extension shroud, each

1

Chapter 3 • Using the Console, Service Module, and Handpieces • 49

35 kHz Straight Handpiece (part # 1523000M3)

24 kHz Laparoscopic Handpiece (part # 1523000M6)

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.

Part # Description Picture

-- Transducer assembly

1523014 Standard tip,

non-sterile, each 1

1523043 Flue (disposable),

non-sterile, single use,
box of 20

1523018 Straight shroud, each 1

Part # Description Picture

-- Transducer assembly

1523029 Laparoscopic Tip,

non-sterile, each 1

1523032 Flue (disposable),

non-sterile, single use,
box of 20

1523028 Step amplifier, each 1

1523030 Laparoscopic Shroud,

each 1

1523031 Laparoscopic Shroud

extension, each 1

50 • Chapter 3 • Using the Console, Service Module, and Handpieces

List of Neurosurgical Handpieces

24 kHz Neurosurgical Short Handpiece (part # 1523000M7)Selector

Part # Description Picture

-- Transducer assembly

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

Cutting Tip, box of 5

NXT3219EA Superior Reverse Bone

Cutting Tip, each 1

NXT3220 Inferior Forward Bone

Cutting Tip, box of 5

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.

Chapter 3 • Using the Console, Service Module, and Handpieces • 51

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.

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).

52 • Chapter 3 • Using the Console, Service Module, and Handpieces

24 kHz Neurosurgical Long Handpiece (part # 1523000M5)

Part # Description Picture

-- Transducer assembly

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

1523049 Angled shroud, each 1

1523045 Clear extension flue, each 1

1523052 Angled extension, each 1

Notice

The flues are packed in either a sterile or non-sterile Tip Set.

Chapter 3 • Using the Console, Service Module, and Handpieces • 53

35 kHz Neurosurgical Handpiece (part # 1523000M9)

Part # Description Picture

-- Transducer assembly

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

1523243EAExtended Length Tip (single

use), sterile, each 1

1523060 Angled shroud, each 1

1523058 Angled extension, 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).

54 • Chapter 3 • Using the Console, Service Module, and Handpieces

List of MicroSurgical Handpieces

24 kHz MicroSurgical Handpiece (part # 1529000M2)

Part # Description Picture

-- Transducer assembly

1529066 MicroSurgical Tip Set (single

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

1529165 MicroSurgical Tip Set (single

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

1529161

MicroSurgical Tip Set (single
use), sterile, 1 tip and 1 flue

1529063

Microsurgical Tip Set, reusable,
non sterile, 1 tip / 5 flues

1529024 Angled shroud, each 1

1529043 Angled extension, each 1

Notice

The flues are packed in either a sterile or non-sterile Tip Set.

Chapter 4 • Preparing the CUSA® NXT for Surgery • 55

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.

56 • Chapter 4 • Preparing the CUSA® NXT for Surgery

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.

3. Using the wrench, tighten the extension by turning it clockwise.

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.

Notice

If you are using either a straight or laparoscopic handpiece, the angled
extension is not required.

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.

2

Chapter 4 • Preparing the CUSA® NXT for Surgery • 57

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.

1

58 • Chapter 4 • Preparing the CUSA® NXT for Surgery

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.

Chapter 4 • Preparing the CUSA® NXT for Surgery • 59

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.

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.

4. Connect tubing from pinch valve (1) to patient waste port on canister.

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.

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.

60 • Chapter 4 • Preparing the CUSA® NXT for Surgery

5. Connect tubing from the contamination guard (2) to the vacuum port (3)

on the canister.

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.

1

2

3

Chapter 4 • Preparing the CUSA® NXT for Surgery • 61

3. Retain the yellow stylet and white hose clips in the sterile field.

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.

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.

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.

2

1

Back End of Handpiece

62 • Chapter 4 • Preparing the CUSA® NXT for Surgery

Connect Tubing to Console

Follow the diagram on the side label of the Console:

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.

Warning

To avoid injury to surgical personnel, keep fingers away from the pump rollers.

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

Chapter 4 • Preparing the CUSA® NXT for Surgery • 63

3. On the left side of the Console, connect the aspiration filter to the

designated port (

2).

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.

Notice

Do not remove the aspiration filter from the designated port prior to powering off
the system.

1

2

64 • Chapter 4 • Preparing the CUSA® NXT for Surgery

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.

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.

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..

Chapter 4 • Preparing the CUSA® NXT for Surgery • 65

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).

66 • Chapter 4 • Preparing the CUSA® NXT for Surgery

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Chapter 5 • Operating the CUSA® NXT During Surgery • 67

CHAPTER 5 OPERATING THE CUSA® NXT SYSTEM

D

URING 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.

Note the following guidelines when using the CUSA NXT during surgery:

Warning

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

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.

Caution

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

68 • Chapter 5 • Operating the CUSA® NXT During Surgery

• 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:

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.

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.

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.

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.

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.

Chapter 5 • Operating the CUSA® NXT During Surgery • 69

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" .

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

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 in from the tip end.

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.

70 • Chapter 5 • Operating the CUSA® NXT During Surgery

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:

Note the

presets settings can be customized depending on surgeon’s needs,

while the

languages settings are customized prior to shipping.

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.

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.

Chapter 5 • Operating the CUSA® NXT During Surgery • 71

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).

72 • Chapter 5 • Operating the CUSA® NXT During Surgery

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Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 73

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

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.

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.

Warning

To avoid injury to surgical personnel, keep fingers away from the pump valve

74 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

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.

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

Do not remove the aspiration filter from the designated port prior to powering off
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.

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.

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.

Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 75

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.

76 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

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.

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

If you are using either a straight or laparoscopic handpiece, the angled
extension is not required.

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.

Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 77

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
Conditions

Minimum
Temperature

Cycle Dwell Time

Minimum
Dry Cycle

Double wrapped
with filters in the lid
and base of
container

134 °C (273 °F) Pre-vacuum cycle 3

minutes

10 Minutes

Pre-vacuum cycle 18
minutes

132 °C (270 °F) Pre-vacuum cycle 4

minutes

Double wrapped
with the lid removed
and filter in the base
of container

134 °C (273 °F) Pre-vacuum cycle 3

minutes

10 minutes

Pre-vacuum cycle 18
minutes

132 °C (270 °F) Pre-vacuum cycle 4

minutes

78 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

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 10

6

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.

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.

Unwrapped with
filters in the lid and
base of container

134 °C (273 °F) Pre-vacuum cycle 3

minutes

10 minutes

Pre-vacuum cycle 18
minutes

132 °C (270 °F) Pre-vacuum cycle 4

minutes

Unwrapped with
filters in the lid and
base of container

134 °C (273 °F) Pre-vacuum cycle 18

minutes

20-30
minutes

Wrapping
Conditions

Minimum
Temperature

Cycle Dwell Time

Minimum
Dry Cycle

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.

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.

Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 79

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

No modification of this equipment is allowed.

80 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

Service Centers

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.

Service Centers Address

United States Integra NeuroSciences

5965 Pacific Center Blvd.Suite 714
San Diego, CA 92121
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

International Integra NeuroSciences

Halskestrasse 25
Ratingen 40880
Germany
Tel: [phone]
Fax: [phone]
E-mail: [e-mail]

Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery • 81

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.

82 • Chapter 6 • Disassembly and Sterilization of CUSA® NXT After Surgery

• 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.

If you do not have suitable packaging please contact your Integra
representative.

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.

Chapter 7 • Troubleshooting the CUSA® NXT System • 83

CHAPTER 7 TROUBLESHOOTING THE CUSA® NXT

S

YSTEM

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.

84 • Chapter 7 • Troubleshooting the CUSA® NXT System

Responding to Alarms

All alarms on the CUSA NXT are low-priority, technical alarms; operator
awareness is required.

Symbol Alarm Causes Recommendations

Aspiration

Tubing not attached to suction
canister.

Attach the tubing to the suction
canister.

Power Improper tip assembly.

• Tighten the tip.

• Reconnect the handpiece.

Bad tip.

• Replace the tip.

• Reconnect the handpiece.

Handpiece Handpiece not connected.

Connect the handpiece to the
appropriate port:

• Red 24 kHz

• Green 35 kHz

• Black 24 kHz

Microsurgical

Two or more handpieces are
connected.

Disconnect extra handpieces.

Footswitch Footswitch not connected.

Connect the Footswitch to the
rear of Console.

More than one Footswitch pedal
is pressed.

Release one Footswitch pedal.

Footswitch pedal is pressed
while connecting components to
the Console.

Release the Footswitch pedal.

General System General system fault.

Restart the system. If the alarm
persists, contact technical
support.

Notice

If you press the yellow symbol, the touch screen monitor will display error
and problem resolution information.

Chapter 7 • Troubleshooting the CUSA® NXT System • 85

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
suction source.

Connect the tubing to the suction source.
See page 59.

Aspiration level displayed on the
touch screen is too low.

Set aspiration level to appropriate level.

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
kinked.

Remove the pinch or kink from the tubing.

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

Console is blocked or occluded.

Unblock the tubing with the stylet or saline
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
be reduced.

Contact technical support.

86 • Chapter 7 • Troubleshooting the CUSA® NXT System

Troubleshooting Irrigation Problems

Problem Causes Recommendations

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
Footswitch.

Replace the Footswitch with a new one.

Irrigation pump is running at an
excessive speed.

Contact technical support.

Liquid permeates the Footswitch. Replace the Footswitch with a new one.

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
irrigation pump correctly.

Reconnect the tubing. See page 62.

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
Footswitch.

Replace the Footswitch with a new one.

Pump does not rotate when pressing
the Footswitch.

Contact technical support.

Liquid permeates the Footswitch. Replace the Footswitch with a new one.

Chapter 7 • Troubleshooting the CUSA® NXT System • 87

Troubleshooting Ultrasonic Power Problems

Problem Causes Recommendations

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;
the pedal will not turn on.

Replace the Footswitch with a new one.

Liquid permeates the Footswitch. Replace the Footswitch with a new one.

Excessive Power The Footswitch power pedal is broken;

the pedal will not turn off.

Replace the Footswitch with a new one.

Liquid permeates the Footswitch. Replace the Footswitch with a new one.

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.

88 • Chapter 7 • Troubleshooting the CUSA® NXT System

This page is intentionally left blank.

Appendix A • Technical Specifications • 89

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

Service Module 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)

Parameter Specification

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

90 • Appendix A • Technical Specifications

Footswitch Specifications

Input Power Source Specifications

Environmental Conditions

Parameter Specification

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)

Parameter Specification

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

Parameter Specification

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

Appendix A • Technical Specifications • 91

Low Frequency Leakage

Power Cord Specifications

Replace fuses with only those of the same type and rating. For details, see
labeling on the rear panel.

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

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.

Parameter Leakage

Touch Current < 100 A

Patient Leakage Current < 10 A





AC Power Supply Power Cord Part # Destination

100 - 120 volts NXT80001 USA/Canada

200 - 240 volts NXT80003/

NXT80002

UK/Europe

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).

92 • Appendix A • Technical Specifications

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

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

Appendix A • Technical Specifications • 93

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.