CUSA EXcel Ultrasonic Surgical Aspirator System User Guide

User’s Guide

CUSA EXcel™ Ultrasonic Surgical Aspirator System

CUSA EXcel™ Ultrasonic Surgical Aspirator System User’s Guide 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 using the CUSA EXcel™ ultrasonic surgical aspirator only. Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Equipment Covered in this Manual

CUSA EXcel™ ultrasonic surgical aspirator with 23 kHz and 36 kHz handpieces. Trademark Acknowledgements

CUSA EXcel™, TissueSelect™, MacroTip™, MicroTip™, PrecisionTip™, CEM™ are trademarks of Integra LifeSciences Corporation., Plainsboro, NJ. Ajax® is a registered trademark of the Colgate-Palmolive Company. Comet® is a registered trademark of Procter & Gamble. Klenzyme® is a registered trademark of Merck & Co., Inc Enzol™ is a registered trademark of Johnson & Johnson Corporation. Force FX™ is a trademark of Valleylab, a division of Tyco Healthcare Group LP. Manufacturer: Integra LifeSciences (Ireland) Limited Tullamore, Co Offaly, Ireland Distributed:

Integra LifeSciences Corportation Plainsboro, NJ 08536 USA; 800-654-2873 © 2007 Integra LifeSciences. All rights reserved. Contents of this publication 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: 4589631 4832021 4988334 5599344

4634419 4846790 5015227 5628745

4734964 4881761 5190517 5847046

4747820 4921476 5287634 6203541

4827911 4931047 5466020

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CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Preface The user’s guide tells about the Integra CUSA EXcel ultrasonic surgical aspirator. It presents the Integra CUSA EXcel as a system that includes a console, handpieces, and accessories: • Descriptions of the system and its functions • Descriptions of the console, its subsystems, and its components • Step-by-step instructions on how to use the console • Descriptions of the handpiece and its components • Step-by-step instructions on how to use the handpiece with the system.

System Features The CUSA EXcel system presents several important features: • It includes both 23 kHz (straight and angled) and 36 kHz (straight) handpieces. • It includes a large variety of 23 kHz and 36 kHz surgical tips that attach to the handpieces: ! Sterile, single-use tips ! Nonsterile, extended-life (6X reusable) laparoscopic tip. • It includes the TissueSelect™ feature, which increases the selectivity of the surgical tip, allowing greater control and precision.

User’s Guide Features The user’s guide is one of several tools you may employ while learning how to use the CUSA EXcel system. We have tried to make this guide as easy to read and to use as possible: • Different sections present different tasks: We realize that different persons may perform different tasks while preparing, sterilizing, setting up, using, shutting down, cleaning, and maintaining the system. Therefore, we present the various tasks in different sections. You won’t need to look through pages of unrelated material to find the one procedure you need. • Section titles and page headers describe specific tasks. This will help you find your way around this guide easily and quickly. • Sections 5, 11, and 14 also include a Quick Reference page. This feature, on page 2 in a section, allows you to recall a procedure at a glance. • Each section includes In this section, a list immediately after the title that gives a brief look at the section contents.

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

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Organization We have organized this guide to introduce the safety issues, the system, and its parts. After safety and the system, the guide gives instructions for preparing, using, troubleshooting, shutting down, and maintaining the system. The guide includes five parts: Part One-Safety Section 1: Patient and Operating Room Safety presents the Warnings, Cautions, and Notices that you need to read and understand to operate the CUSA EXcel system with maximum safety. Part Two-Console Section 2: Introduction to the Console gives an overview of the console and its functions. Section 3: Console Components describes the console, its subsystems, and its components. Section 4: Using CUSA EXcel Console Controls explains the control panel displays and buttons. It also includes guidelines on using the TISSUE Select feature. Section 5: Setting Up the CUSA EXcel System tells you how to prepare the console and its subsystems for use in surgery. It includes instructions on how to complete handpiece assembly, prepare the console for startup, connect and test the handpiece, connect the irrigation and suction systems, prime the system, adjust settings, and switch to the run mode. This section also tells you how to prepare a CUSA Electrosurgical Module (CEM™) nosecone for use with the CUSA EXcel system. Section 6: Shutting Down the CUSA EXcel System explains how to turn off the CUSA system; disconnect suction tubing, irrigation tubing, and the handpiece; and clean the console. Part Three-Handpieces and Accessories Section 7: Introduction to Handpieces gives an overview of handpieces and related accessories. Section 8: Handpiece Components presents the items that compose an assembled handpiece, describing each item by giving physical characteristics and briefly sketching the function each item serves. This section also presents items that, although not a part of the handpiece itself, are essential in assembling a handpiece or preparing it for sterilization. Section 9: Assembling the Handpiece in a Nonsterile Area gives step-by-step instructions for assembling the handpiece and preparing it for sterilization. Section 10: Sterilizing Handpieces and Accessories gives the sterilization parameters you need to ensure that the handpiece is ready for use on the sterile field. Section 11: Completing Handpiece Setup on the Sterile Field describes how to complete the handpiece assembly on the sterile field.

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CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Section 12: Disassembling Handpieces describes how to disassemble and clean the handpiece, and how to clean the tip torquing set. Part Four-Troubleshooting and Maintenance Section 13: Troubleshooting the CUSA EXcel System offers suggestions for problem solving before or during surgery. Section 14: Maintaining the CUSA EXcel System describes a few maintenance tasks that help to keep the CUSA EXcel console and handpieces operating at maximum safety and performance. Part Five-Appendices Appendix A: Technical Specifications gives detailed technical information. Appendix B: Warranty gives limited warranty information. Supplement Book 2 of this guide, Supplement, Assembling or Changing Tips on the Sterile Field, describes how to attach or change sterile tips on the sterile field.

Intended Uses When you receive your CUSA EXcel system, we strongly suggest that you read and understand all of this user’s guide before using the system. However, it also has other uses: • Reference: As you need specific information, you can look it up in the user’s guide. As you become more familiar with the system, you can use the “Quick Reference” pages as time saving reminders of what you need to do. • Training: You can use all or part of this guide when training new persons on your staff to use the CUSA EXcel system.

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

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Conventions Used in this Guide To draw immediate attention to matters of importance, this guide presents Warnings, Cautions, Notices, and Important information in special ways. Warning Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.

Caution Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.

Important Indicates an operating tip or maintenance suggestion.

Notice Indicates a hazard that may result in product damage.

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CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

List of Figures Figure 5-1.

The assembled suction system 5-12

Figure 5-2.

The assembled irrigation system 5-14

Figure 8-1.

The components of a handpiece 8-2

Figure 8-2.

The tip torquing base and torque wrench for use when not changing tips on the sterile field 8-6

Figure 8-3.

The sterilizable torque bases for use when changing tips on the sterile field 8-7

Figure 8-4.

The sterile torque wrench for use when changing tips on the sterile field 8-8

Figure 8-5.

The 23 kHz CUSA Excel sterilizer case 8-9

Figure 9-1.

The items you need to assemble a handpiece: handpiece, nosecone, and tip pack 9-2

Figure 9-2.

Tip torquing base and torque wrench 9-3

Figure 9-3.

Manifold tubing 9-3

Figure 9-4.

The sterilizer case 9-8

Figure 9-5.

The handpiece and connector secured into the sterilizer tray 9-9

Figure 14-1.

Replacing o-rings on the handpiece connector water prongs 14-3

Figure 1.

The sterilized handpiece S-2

Figure 2.

The sterilized standard nosecone and the sterile CEM nosecones S-2

Figure 3.

Sterile tip/flue pack contents. The tip cleaner is inside the flue. S-3

Figure 4.

Sterilizable tip torquing base S-4

Figure 5.

Sterile torque wrench (23 kHz or 36 kHz) S-4

Figure 6.

Sterile manifold tubing S-4

Figure 7.

The handpiece and connector secured into the sterilizer tray S-17

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Notes

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CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Table of Contents CUSA Excel™ Ultrasonic Surgical Aspirator System User’s Guide Preface

ii

iii

System Features

iii

User’s Guide Features Organization

iii

iv

Intended Uses

v

Conventions Used in this Guide List of Figures

Part 1.

vi

xv

Safety

Section 1. Patient and Operating Room Safety Safety Information

1-1

Warnings, Cautions, and Notices General

1-2

1-2

Setting Up the CUSA Excel System

1-2

Shutting Down the CUSA Excel System Handpiece Components

1-3

1-3

Assembling the Handpiece in a Nonsterile Area Disassembling CUSA Excel Handpieces

1-4

Troubleshooting the CUSA Excel System

1-4

Maintaining the CUSA Excel System

1-4

Appendix A. Technical Specifications

1-5

Part 2.

1-4

Console

Section 2. Introduction to the Console For Your Information Overview

2-1

2-2

Fragmentation

2-2

Electromechanical Operation Cooling Irrigation

2-2

2-3 2-3

Aspiration (Suction) Handpieces

2-5

Wide Variety of Tips Intended Uses

2-4

2-5

2-6

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

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Section 3. Console Components For Your Information

3-1

Console Overview and Structural Features I.V. Pole

3-2

3-3

Control Panel

3-3

Arm and Arm Housing

3-3

Housing for Irrigation Pump Head and Suction Pinch Valve Console Body

3-3

Shelf for Suction Canister Casters

3-3

3-3

Control Panel Alerts

3-4 3-5

Lap Mode, Prime, Test, and Status Buttons Displays

3-5

3-5

Status Indicators

3-7

Setpoint Adjustment Buttons Console Body – Front Panel

3-7

3-8

Handpiece Connector Receptacle Suction Pinch Valve

3-9

Irrigation Pump Head

3-9

Contamination Guard

3-9

Retaining Bail for Suction Canister Console Body – Side Panel Control Panel

3-9

3-9

System Power Switch

3-9

3-10

3-11

Rotation Lock Handle

3-11

Housing for Irrigation Pump Head and Suction Pinch Valve I.V. Pole

Arm and Arm Housing Arm Release Tab

Console Body – Rear Panel Speaker

3-11 3-11

3-11

Cooling Water Reservoir

3-11 3-12

3-13

Volume Control

3-13

Footswitch Connector Receptacle AC Main Switch

3-13

3-13

AC Power Cord

3-15

Equipotential Grounding Lug

viii

3-13

3-13

Footswitch

Labels

3-11

3-11

I.V. Pole Release Button

Fuses

3-3

3-15

3-15

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Cord Wrap

3-15

Storage Compartment

3-15

Symbols on the Control Panel

3-16

Section 4. Using CUSA Excel Console Controls For Your Information

4-1

Using Power Switches

4-2

AC Main Switch

4-2

System Power Switch

4-2

Understanding the Control Panel Footswitch Alert

4-3

Handpiece Alert

4-3

Wait/Cooling Water

4-4

Cooling Water Alert

4-4

Test

4-3

4-5

Vibration Alert Prime

4-5

4-6

Standby Status

4-6

Adjusting Setpoint Values Aspiration

4-7

Irrigation

4-7

Amplitude

4-7

TissueSelect

4-7

Changing Functions Run Status

4-8

4-8

Laparoscopic Mode Fast Flush

4-7

4-8

4-8

Quiet Function Using Other Features

4-8 4-9

Filling the Cooling Water Reservoir Raising/Lowering the Arm

4-9

Rotating the Control Panel

4-10

Adjusting the Tone Volume Adjusting the I.V. Pole Using TISSUE Select

4-9

4-10

4-11

4-12

Inherent Tissue Selectivity

4-13

Increasing Tissue Selectivity

4-13

TissueSelect Reduces Reserve Power to the Tip Benefits of TissueSelect

4-14

4-16

A Common Misunderstanding of the Amplitude Setting

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

4-17

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Section 5. Setting Up the CUSA Excel System For Your Information

5-1

Quick Reference – Setup

5-2

Handpiece Assembly

5-2

Console Assembly

5-2

Complete the Handpiece Assembly Items Needed

5-3

5-3

Attach a Nosecone

5-4

Clip the Manifold Tubing to the Handpiece Cable Prepare the System for Startup At the Rear Panel

5-7

5-7

On the Side Panel: Cooling Water On the Front Panel: Suction

5-7

5-8

On the Front Panel: Handpiece Turn On the CUSA Excel System

5-9 5-10

Connect the Suction Tubing

5-10

Connect the Irrigation Tubing

5-12

Test the Handpiece

5-5

5-14

Test the CEM Nosecone

5-15

When the Surgeon Is Ready

5-16

Section 6. Shutting Down the CUSA Excel System Shut Down the CUSA Excel System

6-2

Disconnect Suction Tubing, Irrigation Tubing, and the Handpiece Clean the Console

Part 3.

6-3

6-6

Handpieces and Accessories

Section 7. Introduction to Handpieces For Your Information Description Functions

7-2 7-2

Configurations

7-3

Wide Variety of Tips

x

7-1

7-3

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Section 8. Handpiece Components For Your Information

8-1

Components of Assembled Handpieces Handpiece O-Rings

8-2 8-3

Nosecone Tip

8-4

Flue

8-5

8-2

8-3

Manifold Tubing

8-5

Additional Components

8-6

Nonsterile Tip Torquing Base and Torque Wrench Sterilizable Torque Bases

8-7

Sterile Torque Wrenches

8-7

Sterilizer Cases

8-6

8-8

Section 9. Assembling the Handpiece in a Nonsterile Area For Your Information Items Needed

9-1

9-2

Attach the Tip to the Connecting Body Put On the O-Rings

9-4

9-6

Clip the Manifold Tubing to the Handpiece Cable (Optional) Package the Handpiece for Sterilization Items Needed

9-7

9-8

9-8

Section 10. Sterilizing Handpieces and Accessories For Your Information

10-1

Sterilization Parameters

10-2

Handpieces without Manifold Tubing

10-2

Handpieces with Manifold Tubing Attached Sterilize the Handpiece

10-2

10-3

Sterilizing with Steam

10-3

Validation of Steam Sterilization Parameters

10-3

Section 11. Completing Handpiece Setup on the Sterile Field For Your Information

11-1

Quick Reference – Setup

11-2

Handpiece Assembly

11-2

Complete the Handpiece Assembly Items Needed

11-3

11-3

Attach a Nosecone

11-4

Clip the Manifold Tubing to the Handpiece Cable Cover the CEM Nosecone

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

11-6

11-9

xi

Section 12. Disassembling Handpieces For Your Information

12-1

Disassemble the Handpiece Clean the Handpiece

12-2

12-5

Clean the Tip Torquing Set

Part 4.

12-6

Troubleshooting and Maintenance

Section 13. Troubleshooting the CUSA Excel System For Your Information

13-1

Responding to Alerts

13-2

General Troubleshooting

13-5

Section 14. Maintaining the CUSA Excel System For Your Information Quick Reference

14-1

14-2

Clean the Sterilizer Case

14-3

Maintain the Handpiece

14-3

Lubricate the Handpiece Connector O-Rings

14-3

Replace the Handpiece Connector O-Rings

14-3

Recalibrate the Handpiece

14-4

Store the CUSA Excel System and Accessories CUSA Excel Console Handpiece

14-4

Footswitch

14-4

CEM Nosecone

14-4

14-4

Return Equipment for Service

14-4

Obtaining a Return Authorization Number Returning the Console

14-5

Returning Handpieces

14-5

Ordering Replacement Parts Integra Service Centers

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14-4

14-5

14-5

14-6

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Part 5.

Appendix

Appendix A. Technical Specifications Console Dimensions

A-1

CUSA Excel Console Footswitch

A-1

A-1

Console Subsystems Ultrasonic

A-2

A-2

Fluidic System

A-2

Electrical Requirements

A-3

Input Power Source

A-3

Power Cords

A-3

Low Frequency Leakage Duty Cycle

A-3

A-3

Environment

A-4

Standards and IEC Classifications

A-4

Class I Equipment (IEC 601-1)

A-5

Type BF Applied Part Equipment (IEC 601-1) IPX - 8 (IEC 529, UL60601) Footswitch Electromagnetic Interference

A-5

System Power Off / Standby

A-5

Pinch Point in the Suction Pinch Valve Fuse Replacement

A-6

Voluntary Standards

A-6

Statutory and Regulatory Requirements Handpieces

A-5

A-5

A-5

Footswitch Symbols

EMC Compatibility

A-5

A-6

A-6

A-7

Nominal Frequencies Dimensions

A-7

Tip Specifications

A-7

23 kHz

A-8

36 kHz

A-9

A-7

Appendix B. Warranty

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Supplement. Assembling or Changing Tips on the Sterile Field For Your Information Items Needed Assembly

S-1

S-2 S-5

Attach the Tip and O-rings

S-5

Attach a Nosecone and Flue

S-7

Attach the Manifold Tubing

S-9

Complete the CEM Setup

S-10

Disassembly to Change Tips on the Sterile Field Disconnect the Manifold Tubing

S-11

Remove the Nosecone, O-rings, and Tip Disassembly After the Surgical Procedure Reprocess the Handpiece

S-15

Clean the Handpiece

S-15

Reprocess the Sterilizable Torque Base Clean the Base

S-12 S-14

S-16

S-16

Package the Handpiece for Sterilization

xiv

S-11

Package the Base for Sterilization

S-18

Sterilize the Handpiece and Base

S-18

S-17

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

Part 1 Safety

SECTION

1

Patient and Operating Room Safety

1

In this section: • Indications for Use • Safety information • Warnings, Cautions, and Notices, organized by section.

Indications for Use The CUSA EXcel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard 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.

Safety Information The safe and effective use of ultrasonic surgery depends to a large degree on factors solely under the control of the operator. There is no substitute for a properly trained and vigilant operating room staff. It is important that they read, understand, and follow the operating instructions supplied with this ultrasonic equipment. Physicians have used ultrasonic equipment safely in numerous procedures. Before starting any surgical procedure, the surgeon should be familiar with the medical literature, complications, and hazards of using ultrasonic surgery in that procedure.

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide

1-1

Warnings, Cautions, and Notices

Warnings, Cautions, and Notices To promote the safe use of the CUSA EXcel ultrasonic surgical aspirator, this section presents the warnings, cautions, and notices that appear throughout this user’s guide. So that you can operate this equipment with maximum safety, it is important that you read, understand, and follow the instructions in these warnings, cautions, and notices. It is also important that you read, understand, and follow the instructions in this user’s guide.

General Caution Read the instructions, cautions, and warnings provided with the CUSA EXcel system before using it. Otherwise injury to the patient, injury to surgical personnel, or equipment damage may result. Notice Do not allow fluids to enter the chassis.

Setting Up the CUSA EXcel System Warning When not in use, keep active accessories away from the patient. Place the handpiece on a flat, clean, dry, nonconductive, and highly visible surface. To avoid inadvertent activation of the CEM nosecone when not in use, place the assembled handpiece so that the weight of the handpiece does not rest on the nosecone activation buttons. Do not place other objects on the handpiece. Inadvertent contact between handpiece accessories and the patient may result in burns. Electric Shock Hazard – When simultaneously using an electrosurgical generator with a standard monopolar pencil and an activated ultrasonic handpiece, contact between the pencil blade and the vibrating tip creates sparking and possible tip fracture. The sparking and tip fracture result in product damage. The sparking and tip fracture can also result in injury to the patient, surgeon, or operating room staff. To avoid the effects of contact between the electrosurgical pencil blade and the ultrasonic tip, • Ensure that the electrosurgical generator is at its lowest effective power setting. • Do not allow the pencil blade to contact the exposed end of the ultrasonic tip or the pre-aspiration holes at any time. For greater safety when both electrosurgery and ultrasonics are necessary, use the CEM system. The reduced voltage from CEM provides hemostasis without damage to the ultrasonic tip

1-2

CUSA Excel Ultrasonic Surgical Aspirator System User’s Guide