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
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