Integra CUSA NXT Manual de usuario

Confidential – For internal use only.

NS3042-12/08

Ultrasonic Tissue Ablation System

In-Service Guide

Page 2

CUSA NXT™ In-Service Guide

NS3042-12/08

Confidential - For internal use only.

Table of Contents

Introduction

 Equipment Check List

 Equipment from the Loaner Pool

Page 3

Page 4

CUSA NXT In-Service Check List for NeuroSpecialist Page 5

CUSA NXT System

 CUSA NXT Console

 CUSA NXT Touch Screen Monitor

 CUSA NXT Service Module

 CUSA NXT Handpieces

Page 7

Page 11

Operating CUSA NXT During the Surgery

 Customizing the User Settings

Page 16

Page 17

Shutting Down the CUSA NXT™ System

 Dismantling the System After the Surgery

 Disassembling the Handpiece

 Guidelines for Cleaning the Handpieces

Page 18

Page 19

Sterilization Instructions

 Recommended Sterilization Instructions

 Steam Sterilization

Page 20

Product Support Page 21

CUSA NXT Pre-Operative Set-up

 Console and Service Module Set-up

 Handpiece Assembly

 Tubing Assembly

 Priming the Handpiece

Page 12

Page 13

Page 14

Page 15

Appendix 1: CUSA NXT Pool Request Form

Appendix 2: CUSA NXT Competency Validation Form for the Hospital

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CUSA NXT™ In-Service Guide

NS3042-12/08

Confidential - For internal use only.

Introduction

As a NeuroSpecialist at Integra NeuroSciences, you are representing a comprehensive line of

market leading ultrasonic aspirators, including the new CUSA NXT. Your competency at ex-

plaining the CUSA NXT System features and benefits and operating the equipment and dem-

onstrating its functions will help ensure that your customers Operate with Confidence™!

On a daily basis you are asked to do non-clinical and clinical evaluations, in-service the staff

and the surgeons, provide sterilization instructions for the handpieces, explain how the system

works, and much more. This In-Service Guide is put together to help you manage these vari-

ous tasks with CUSA NXT, and deliver to your accounts the high quality customer service and

support they expect.

Equipment Check List

Before you schedule an evaluation, a demo or an in-service, make sure that you have all the

needed equipment available.

CUSA NXT System

 CUSA NXT Console

 CUSA NXT Service Module

 Footswitch

 Different 24 kHz and 35 kHz CUSA Selector

handpieces

 Handpiece sterilization trays

 Manifold tubing

 Micro tubing kit extension, if MicroSurgical

handpiece is used

 MRI tubing kit extension, if MRI safe hand-

pieces are used

 Tips and flues

 Wrench sets for handpieces

 Contamination guard for the Service Module

 CUSA NXT in-service DVD

 Sterilization instructions

Hospital provided components

 500 ml (or more) of normal IV saline or Lac-

tated Ringers

 Suction canister

Accessories for non-clinical demo

 Apple for removing the pulp from the skin

 Orange to dissect the pulp from the segments

 Permastone bone cube and/or T-bone steak

or pork chop for Selector SaberTip™ demon-

stration

 Plate to place the items on

 Knife to cut the apple and orange

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CUSA NXT™ In-Service Guide

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Confidential - For internal use only.

Equipment from the Demo Pool

If you need to obtain any items from the loaner pool, please do so by taking the following

steps:

1. Fill in the CUSA NXT Pool Request form (see Appendix 1)

 Please contact sales support to get your copy if you don’t already have one

 Remember to request the Console and Service Module shipping crates in the form

 Remember to request the wrench sets for the handpieces as well, as they do not

automatically ship with the handpieces.

2. Email the form to: [email protected]

All CUSA NXT Consoles, Service Modules and CUSA Selector handpieces in the demo pool

ship from our Service and Repair Center in San Diego, CA.

Before returning loaner pool equipment, please contact San Diego at 1-858-455-1115 ext.

207 to get an RMA for your return shipment.

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CUSA NXT™ In-Service Guide

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Confidential - For internal use only.

CUSA NXT In-Service Check List for the NeuroSpecialist

Below you will find an In-Service Check List to guide you through the in-service situation. As

some hospitals require competency validation forms for their staff training purposes, we have

put together one (see Appendix 2). This form is also available in PDF and you can download

a copy from the Tissue Ablation SharePoint site.

1. Discuss the basic principles of ultrasonics

 Fragmentation

 Irrigation

 Aspiration

2. Discuss the main differentiating features and benefits of the CUSA NXT System

 Ease of set-up

 Modularity

 Separate Console and Service Module

 Ability to hook up the Console to hospital wall suction

 NXT Digital Architecture™

 Touch screen user-interface

 Custom presets

 On-line help

 Linear footswitch

 Digital architecture

 Advanced aspiration system

 MRI safety

 Selector Saber Tip™

3. Identify the main clinical uses for the CUSA NXT

 Neurosurgery

 General surgery (liver)

 GYN/Oncology

4. Identify the components of the CUSA NXT System

 CUSA NXT System components:

 CUSA NXT Console

 CUSA NXT Service Module

 Footswitch

 Touch-screen user-interface

 Different 24 kHz and 35 kHz CUSA Selector handpieces

 Handpiece sterilization trays

 Manifold tubing

 Micro tubing kit extension, if MicroSurgical handpiece is used

 MRI tubing kit extensions, if MRI compatible handpieces are used

 Tips and flues

 Wrench sets

 Contamination guard for the Service Module

 CUSA NXT in-service DVD

 Hospital provided components:

 500 ml (or more) of normal IV saline or Lactated Ringers

 Suction canisters

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CUSA NXT™ In-Service Guide

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Confidential - For internal use only.

5. Perform the in-service for the CUSA NXT

 Setting up the Console

 Setting up the 24 kHz and 35kHz handpieces and explaining the handpiece con-

nections

 Touch screen user-interface

 Recommended settings

 80 % power, 3 ml/min irrigation, 80 % aspiration for soft tissue

 80 % power, 6 ml/min irrigation, 80 % aspiration for hard tissue bone)

 Custom Presets

 Alerts

 On-line help

 In-service DVD

6. Set up the CUSA NXT System for the clinical evaluation or surgery

 Setting up the Console and Service Module

 Setting up the 24 kHz and 35 kHz handpieces

7. Operate the CUSA NXT in non-clinical evaluations

 Removal of apple pulp from the skin

 Orange segment dissection

 Permastone bone cube for the CUSA Selector SaberTip demo

8. Troubleshoot the CUSA NXT if it fails to operate or if it malfunctions

 Handpiece Alert

 Aspiration Issues

 Irrigation Issues

 Ultrasonic Power Issues

 Refer to the CUSA NXT Troubleshooting Guide or CUSA NXT Operator’s Manual for

detailed troubleshooting guidelines

9. Shut down the CUSA NXT system after the surgery/evaluation

 Disassembling the system and handpieces

 Discarding the disposable items in a proper manner

10. Communicate the proper cleaning and sterilization protocols to the OR Staff and SPD

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CUSA NXT™ In-Service Guide

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CUSA NXT System

The use of the CUSA NXT will require the following items:

 CUSA NXT Console

 CUSA NXT Service Module or hospital wall suction outlet

 One hard waste collection canister

 Tubing Kit

 MicroSurgical Tubing Kit Extension (if MicroSurgical hand-

piece is used)

 MRI Tubing Kit Extension (if MRI handpieces are used)

 IV bag: 500 ml (or more) saline or Lactaid Ringers

 CUSA Selector handpiece(s)

 CUSA Selector handpiece wrench set, appropriate to the

handpiece

 CUSA Selector handpiece sterilization tray(s)

CUSA NXT Console

Console rear panel

1. Power button

2. AC power inlet

3. Cooling fan air outlet

4. Footswitch port

5. Ground point

6. Volume control knob

Console left side panel

1. Irrigation pump

2. Aspiration control port

3. Pinch valve

4. Handpiece connection port for the 24 kHz handpiece

5. I.V. pole

Console front panel

1. Handpiece connection port for the 35 kHz handpiece

2. Handpiece connection port for the 24 kHz microsurgical

handpiece

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CUSA NXT™ In-Service Guide

NS3042-12/08

Confidential - For internal use only.

CUSA NXT Touch Screen Monitor

The CUSA NXT Console provides a touch screen monitor for viewing and controlling the

power, irrigation and aspiration levels during an ultra-

sonic case.

The touch screen provides the following tools:

1. Status and alarm symbols

2. Ultrasonic control scales for power, irrigation and as-

piration

3. Information panel displaying the accumulated ultra-

sonic time and the current vacuum levels

4. Menu buttons for priming the handpiece, customizing

the user settings and viewing the online help.

Status and Alarm Symbols

The file symbols appear on the top of the touch screen providing status information on the

major ultrasonic components. 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 sym-

bol will turn from green to flashing yellow.

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CUSA NXT™ In-Service Guide

NS3042-12/08

Confidential - For internal use only.

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 ampli-

tude). The power settings range between 10% and 100%. 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.

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. To adjust

this rate by 1 ml/minute increments, use the arrows to the right of the scale. To ad-

just the rate by 2 ml/minute increments, press the desired segment on the scale.

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. 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 be-

tween 30% and 100%.

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CUSA NXT™ In-Service Guide

NS3042-12/08

Confidential - For internal use only.

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:

 The Timer 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.

 The Vacuum symbol displays the current vacuum level from the

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

Displaying Menus for Prime Mode, Customized Settings, and Online Help

Use the menu buttons to access features for priming the handpiece, customizing user settings,

and displaying online help. Note the following buttons:

 Prime: Displays the prime panel for priming the handpiece for surgery

 Settings: Displays options for saving customized settings and specify-

ing different languages.

 Help: Displays the online help system for accessing information on

performing common tasks.

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