Integra Cusa Excel Manual de usuario

CUSA EXcel®Ultrasonic Surgical Aspirator Service Manual

Integra LifeSciences Corporation

311 Enterprise Drive • Plainsboro, NJ 08536

USA and Canada 800.997.4868 • (Outside USA) 609.936.5400 • (Fax) 888.980.7742

www.Integra-LS.com

Camino, CUSA, CUSA Excel, DuraGen Plus, Integra NeuroSciences, OSV II, and Radionics are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Auragen, Operate with Confidence, Ruggles, and the Integra wave logo are trademarks of Integra LifeSciences Corporation or its subsidiaries.

MAYFIELD is a registered trademark of SM USA Inc. and is used by Integra LifeSciences Corporation under license.

Radionics®MAYFIELD® Auragen™Ruggles™CUSA® OSV II® DuraGen Plus® Camino®

Stereotaxy Stabilization Brain Mapping Instruments Tissue Ablation CSF Management Duraplasty NeuroCritical Care

OPERATE WITH CONFIDENCE™

Integra LifeSciences Corporation

311 Enterprise Drive • Plainsboro, NJ 08536

Customer Service USA and Canada: 800.997.4868 • 609.936.5400 (Outside USA) • 888.980.7742 (Fax)

www.Integra-LS.com

Camino, CUSA, DuraGen Plus, Integra NeuroSciences, OSV II, and Radionics are registered trademarks of Integra LifeSciences Corporation or its subsidiaries.

Auragen, Operate with Confidence, Ruggles, and the Integra wave logo are trademarks of Integra LifeSciences Corporation or its subsidiaries.

MAYFIELD is a registered trademark of SM USA Inc. and is used by Integra LifeSciences Corporation under license.

Ultrasonic Surgical Aspirator Service Manual

Distributed By:

Integra LifeSciences Corporation

Plainsboro, NJ 08536 USA

Integra LifeSciences (Ireland) Limited

IDA Business and Technology Park

Sragh

Tullamore, County Offaly, Ireland

945103104ILS, Rev. A

USEnglishCover_Update_April09_18x12.indd 1 7/17/09 10:02 AM

Service Manual

CUSA EXcel®Ultrasonic Surgical

Aspirator System

ii CUSA EXcel Ultrasonic Surgical System Service Manual

Preface

This manual and the equipment it describes are for use only by qualified medical

professionals trained in the particular technique and surgical procedure to be

performed. It is intended as a guide for servicing the CUSA EXcel®ultrasonic

surgical aspirator only.

Equipment covered in this manual

CUSA EXcel®ultrasonic surgical aspirator with 23 kHz and 36 kHz handpieces.

The CUSA EXcel®Ultrasonic Surgical Aspiration System Service Manual

consists of two parts—the text (part 1 of 2) and a Schematics Supplement (part 2

of 2), which contains the schematics.

Trademark acknowledgements

CUSA EXcel, TissueSelect, MacroTip, MicroTip, PrecisionTip, CEM, and Force

FX are trademarks of Integra LifeSciences Corporation or its subsidiaries.

Ajax®is a registered trademark of the Colgate-Palmolive Company.

Comet®is a registered trademark of Procter & Gamble.

Torque Seal®is a registered trademark of Organic Products Co.

Manufactured by

Integra LifeSciences (Ireland) Limited

IDA Business & Technology Park

Sragh

Tullamore, CO Offaly, Ireland

Distributed by

Integra LifeSciences Corporation

Plainsboro, NJ 08536, USA

800-997-4868

may not be reproduced in any form without the written permission of Integra.

Patent Information

One or more of the following U.S. patents and corresponding foreign patents

cover the CUSA EXcel system

Additional patents pending.

Caution

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

4634419 4734964 4747820 4827911 4846790

4881761 4921476 4931047 4988334 5015227

5190517 5312329 5421829 5466020 6083191

6214017 6256859 6499358 6602227 6654999

D438952

0086

CUSA EXcel Ultrasonic Surgical System Service Manual iii

About This Manual

The service manual describes the CUSA EXcel ultrasonic surgical aspirator. It

presents the CUSA EXcel as a system that includes a console, handpieces, and

accessories:

• Descriptions of the system, its functions, specifications, and theory of

operation

• Step-by-step instructions on how to unpack, install, maintain, calibrate, and

troubleshoot the system

• Step-by-step instructions on how to replace specific components

• Parts lists, board layouts, and schematics.

Organization

We have organized this guide to introduce the safety issues, the system, and its

functions. After safety and the system, the guide gives instructions for unpacking

the system, then describes its components, technical specifications, and theory of

operation. The next sections tell you how to check out, maintain, troubleshoot,

replace parts, and calibrate the system. A schematics supplement includes printed

circuit board (PCB) layouts and schematics.

iv CUSA EXcel Ultrasonic Surgical System Service Manual

Important

Conventions Used in this Guide

Indicates an operating tip or

maintenance suggestion.

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in death or

serious injury.

Caution

Indicates a hazardous situation which, if not avoided, may result in minor or moderate

injury.

Notice

Indicates a hazard which may result in product damage.

CUSA EXcel Ultrasonic Surgical Aspirator System Service Manual v

Table of Contents

Preface 1-ii

About This Manual 1-iii

Organization 1-iii

Conventions Used in this Guide 1-iv

List of Figures 1-xiii

List of Tables 1-xv

Section 1. Service Personnel Safety

Safety Information 1-1

Warnings, Cautions, and Notices 1-1

General 1-2

Introduction 1-2

Unpacking and Installing the CUSA EXcel System 1-2

Console Components 1-2

Technical Specifications 1-2

Checkout Procedures 1-2

Maintaining the CUSA EXcel System 1-3

Troubleshooting 1-4

Replacement Procedures 1-4

Calibration 1-5

Repair Policy 1-5

Section 2. Introduction

For Your Information 2-1

Overview 2-2

Fragmentation 2-2

Tip Motion 2-2

Cooling 2-2

Irrigation 2-3

Aspiration (Suction) 2-4

Handpieces 2-5

Wide Variety of Tips 2-5

Section 3. Unpacking and Installing the CUSA EXcel Surgical

Aspirator System

The Responsibility of the Manufacturer 3-1

Unpacking the CUSA EXcel System 3-2

Tools You Will Need 3-2

Unpacking Procedure 3-2

Preparing the CUSA EXcel Console for Use 3-8

vi CUSA EXcel Ultrasonic Surgical Aspirator System Service

Replacing the Power Connector 3-9

Section 4. Console Components

For Your Information 4-1

Console Overview and Structural Features 4-2

I.V. Pole 4-3

Control Panel 4-3

Arm and Arm Housing 4-3

Housing for Irrigation Pump Head and Suction Pinch Valve 4-3

Console Body 4-3

Shelf for Suction Canister 4-3

Casters 4-3

Control Panel 4-4

Alerts 4-5

Lap Mode, Prime, Test, and Status Buttons 4-5

Displays 4-5

Status Indicators 4-7

Setpoint Adjustment Buttons 4-7

Console Body Front Panel 4-8

Handpiece Connector Receptacle 4-8

Suction Pinch Valve 4-9

System Power Switch 4-9

Irrigation Pump Head 4-9

Contamination Guard 4-9

Retaining Bail for Suction Canister 4-9

Console Body Side Panel 4-10

Control Panel 4-11

Rotation Lock Handle 4-11

Housing for Irrigation Pump Head and Suction Pinch Valve 4-11

I.V. Pole 4-11

I.V. Pole Release Button 4-11

Arm and Arm Housing 4-11

Arm Release Tab 4-11

Cooling Water Reservoir 4-11

Console Body Rear Panel 4-12

Speaker 4-13

Volume Control 4-13

Footswitch Connector Receptacle 4-13

AC Main Switch 4-13

Fuses 4-13

Footswitch 4-13

AC Power Cord 4-15

Equipotential Grounding Lug 4-15

CUSA EXcel Ultrasonic Surgical Aspirator System Service Manual vii

Label 4-15

Cord Wraps 4-15

Storage Compartment 4-15

Symbols on the Control Panel 4-16

Other Features 4-17

Filling the Cooling Water Reservoir 4-17

Raising/Lowering the Arm 4-17

Rotating the Control Panel 4-18

Adjusting the Tone Volume 4-18

Adjusting the I.V. Pole 4-19

Section 5. Technical Specifications

Console Dimensions 5-2

CUSA EXcel Console 5-2

Footswitch 5-2

Console Subsystems 5-2

Ultrasonic 5-2

Fluidic System 5-3

Electrical Requirements 5-3

Input Power Source 5-3

Power Cords 5-3

Low Frequency Leakage 5-4

Duty Cycle 5-4

Environment 5-4

Standards and IEC Classifications 5-5

Class I Equipment (IEC 601-1) 5-5

Type BF Applied Part Equipment (IEC 601-1) 5-5

IPX - 8 (IEC 529, UL60601) Footswitch 5-5

Electromagnetic Interference 5-6

System Power Off / Standby 5-6

Pinch Point in the Suction Pinch Valve 5-6

Fuse Replacement 5-6

Footswitch Symbols 5-6

Voluntary Standards 5-7

Statutory and Regulatory Requirements 5-7

EMC Compatibility 5-7

Handpieces 5-12

Nominal Frequencies 5-12

Dimensions 5-12

Tip Specifications 5-12

23 kHz 5-13

36 kHz 5-14

viii CUSA EXcel Ultrasonic Surgical Aspirator System Service

Section 6. Principles of Operation

How the Handpiece Works 6-2

Electromechanical Operation 6-2

Fragmentation 6-3

Cooling 6-3

How the TissueSelect Feature Works 6-4

Inherent Tissue Selectivity 6-5

Increasing Tissue Selectivity 6-5

TissueSelect Reduces Reserve Power to the Tip 6-6

Benefits of TissueSelect 6-8

A Common Misunderstanding of the Amplitude Setting 6-9

Section 7. Circuit Theory

For Your Information 7-1

Display Board 7-2

General Description 7-2

Fundamentals of Operation 7-2

Detailed Circuit Description 7-3

Machine Control Board 7-4

Introduction 7-4

Irrigation Pump 7-4

Suction Pump 7-4

Cooling Pump 7-6

Suction Valve 7-6

Amplitude Control 7-6

Valve Controls 7-7

Power Control Input and Output Signals 7-7

Voltage Regulators 7-8

Interface Connectors 7-8

Ultrasonics Board–Ultrasonic Generator 7-8

Fundamentals of Operation 7-8

The Main Frequency Loop 7-9

Bandpass Filter (BPF) 7-9

AGC/Error Amplifier Circuit 7-10

Phase Compensator 7-11

Driver Stage 7-11

Feedback Signal 7-12

Bias Circuitry 7-12

Frequency Selection Circuitry 7-12

Ultrasonics Board–Other Circuits 7-13

Audible Alert and Operation Indicator 7-13

Valve Drivers 7-13

CUSA EXcel Ultrasonic Surgical Aspirator System Service Manual ix

Power and Other Signal Connections 7-13

System 24 V Power Supply Board 7-13

Section 8. Checkout Procedures

Inspections 8-1

Footswitch 8-1

Power Cord 8-2

Power On Verification 8-2

Handpiece Test (Optional) 8-2

Section 9. Maintaining the CUSA EXcel System

For Your Information 9-1

Recommended Maintenance Schedule 9-2

Clean the CUSA EXcel Console 9-3

Clean the Sterilizer Case 9-3

Maintain the Handpiece 9-3

Clean the Handpiece 9-4

Lubricate the Handpiece Connector O-Rings 9-5

Replace the Handpiece Connector O-Rings 9-5

Recalibrate the Handpiece 9-5

Maintain the Tip Torquing Set 9-6

Clean the Tip Torquing Set 9-6

Check the Torque on the Tip Torquing Wrench 9-6

Store the CUSA EXcel System and Accessories 9-7

CUSA Console 9-7

Handpiece 9-7

Footswitch 9-7

CEM Nosecone 9-7

Section 10. Troubleshooting

For Your Information 10-1

Troubleshooting Safety 10-2

User Troubleshooting 10-2

Responding to Alerts 10-3

General Troubleshooting 10-6

Engineer Troubleshooting 10-15

Guidelines 10-15

Flowcharts 10-15

No Power 10-16

Handpiece Alarm 10-17

Footswitch Alarm 10-18

Cooling Water Alarm 10-19

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