CUSA Excel and Excel +Users Guide Rev D

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide This User’s Guide 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 and CUSA® Excel+ Ultrasonic Surgical Aspirator System only.ystem.stem only. Equipment Covered in this Manual The CUSA Excel refers to the following product models: CUSA Excel and CUSA Excel-8. Both product models utilize 23 kHz and 36 kHz handpieces. The CUSA Excel+ refers to the product models: CUSA Excel 2 and CUSA Excel-9. The system incorporates graphic modifications of the logo design and color of the top cover of the system. The CUSA Excel+ System utilizes the same CUSA Excel family of handpieces.

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Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Trademark Acknowledgements Integra, the Integra logo, CUSA, CUSA Excel and Tissue Select are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. MacroTip, MicroTip, PrecisionTip, SaberTip, CEM and ShearTip are trademarks of Integra LifeSciences Corporation or its subsidiaries. Ajax is a registered trademark of Colgate-Palmolive Company. Comet is a registered trademark of the Spic and Span Company. Klenzyme is a registered trademark of Steris Corporation. Enzol is a registered trademark of Johnson & Johnson. All other trademarks and trade names are the property of their respective owners. Manufacturer: Integra LifeSciences (Ireland) Limited IDA Business & Technology Park Sragh Tullamore, County Offaly, Ireland Distributed By: Integra LifeSciences Corporation Plainsboro, NJ 08536 USA; 1-800-997-4868

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© 2018 Integra LifeSciences Corporation. All Rights Reserved. Contents of this publication may not be reproduced in any form without the written permission of Integra. Patent Information U.S. Patents 6,214,017; 6,499,358; 6,602,227; 7,204,825; 8,118,823; 8,142,460; 8,518,066; 9,421,027; additional patent(s) pending.

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Preface This User’s Guide describes how to use the Integra® CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System. It presents the Integra CUSA Excel/CUSA Excel+ as a system that includes a console, handpieces, and accessories. It describes: •

The System and its functions.

•

The Console, its subsystems, and its components.

•

The Handpiece and its components.

•

How to setup and use the console.

•

How to assemble and use the handpiece with the system. Notice A technical description of the CUSA Excel/CUSA Excel+ System is provided in the CUSA Excel/CUSA Excel+ System Ultrasonic Surgical Aspirator System Service Manual. The Service Manual is not supplied with the system as it is intended to be used only by Integra service personnel and/or their agents.

System Features The CUSA Excel/CUSA Excel+ System includes several important features: •

23 kHz (straight and angled) and 36 kHz (straight) handpieces

•

A large variety of 23 kHz and 36 kHz surgical tips that attach to the handpieces:  Sterile, single-use tips  Nonsterile, extended-life tips

•

Tissue Select® feature, which increases the selectivity of the surgical tip, allowing greater control and precision.

Organization This User’s Guide is organized into these sections: •

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/CUSA Excel+ System with maximum safety.

•

Section 2: Introduction to the CUSA Excel/CUSA Excel+ System gives an overview of the console and its functions, and an overview of handpieces and related accessories.

•

Section 3: Console Components describes the console, its subsystems and its components.

•

Section 4: Control Panel Display and Functions describes the control panel display, the signs and symbols on the control panel and the control panel behavior during system startup and operation.

•

Section 5: Setting Up the CUSA Excel/CUSA Excel+ System explains how to prepare the console and its subsystems for use in surgery. It includes the handpiece assembly options; how to prepare the console for startup, connect and test the handpiece, connect the irrigation and suction systems; how to prime the system, adjust settings, and switch to the Run mode.

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Section 6: Using CUSA Excel/CUSA Excel+ Console Controls describes the control panel buttons and functions. It also includes guidelines on using the Tissue Select feature.

•

Section 7: Handpiece Components presents the items that compose an assembled handpiece, their physical characteristics, and the function of each item. It also presents items that, although not a part of the handpiece itself, are essential in assembling a handpiece or preparing it for sterilization.

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Section 8: Assembling the Handpiece in a Nonsterile Area provides step-bystep instructions for assembling the handpiece and preparing it for sterilization.

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Section 9: Sterilizing Handpieces and Accessories provides the sterilization parameters you need to ensure that the handpiece is ready for use in the sterile field.

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Section 10: Completing Handpiece Setup in the Sterile Field describes how to complete the handpiece assembly in the sterile field.

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Section 11: Assembling or Changing Tips in the Sterile Field describes how to attach or change sterile tips in the sterile field.

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Section 12: Shutting Down the CUSA Excel/CUSA Excel System explains how to turn off the system; disconnect suction tubing, irrigation tubing, and the handpiece; and how to clean the console.

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Section 13: Disassembling Handpieces describes how to disassemble and clean the handpiece, and how to clean the tip torquing set.

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Section 14: Troubleshooting the CUSA Excel/CUSA Excel+System offers suggestions for problem solving before or during surgery.

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Section 15: Maintaining the CUSA Excel/CUSA Excel+System describes the maintenance tasks that help to keep the console and handpieces operating as intended.

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Appendix A: Technical Specifications provides detailed technical information.

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Appendix B: Sterilization Validation provides information on the sterilization validation procedure.

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Appendix C: Warranty provides warranty information.

Intended Uses When you receive your CUSA Excel/CUSA Excel+ System, we recommend that you read and understand all of this User’s Guide before using the system. Also, use the guide for: •

Reference - When you need specific information on a task. Once you are familiar with the system, use the “Quick Reference” cards (located behind the Control Panel).

•

Training - When training new personnel to use the system.Conventions Used in this Guide

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

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

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.

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Table of Contents Section 1. Patient and Operating Room Safety Indications for Use Intended Users

1-1

1-1 1-2

Safety Information

1-2

Warnings, Cautions, and Notices

1-3

Classification and Console Symbols

1-9

Section 2. Introduction to the System For Your Information

2-1

2-1

®

About the CUSA Excel/CUSA® Excel+ System About the Handpieces

About the Tissue Select® Feature

2-6

Sterilization of Handpieces and Accessories

Section 3. Console Components For Your Information

2-2

2-4 2-9

3-1

3-1

About the Console and Structural Features Console Body – Front Panel

3-4

Console Body – Side Panel

3-7

Console Body – Rear Panel

3-9

About the Power Switches

3-13

3-2

Section 4. Control Panel Display and Functions For Your Information

4-1

4-1

About the Control Panel Display

4-2

Signs and Symbols on the Excel8 and Excel9 Control Panel

4-10

Signs and Symbols on the Excel and Excel 2 Control Panel

4-12

Understanding the Control Panel at System Startup

Section 5. Setting Up the System For Your Information

5-1

5-1

Quick Reference – Setup

5-2

Handpiece Assembly Options

5-3

Preparing the System for Startup Turning On the System

5-4

5-7

Connecting the Suction Tubing

5-7

Connecting the Irrigation Tubing

5-9

Testing the Handpiece

5-11

Testing the Alarm Tone

5-12

When the Surgeon Is Ready

5-13

Section 6. Using the Console Controls For Your Information

4-13

6-1

6-1

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

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Adjusting Setpoint Values Changing Functions

6-1

6-3

Using the Tissue Select Feature Using Other Features

6-4

6-6

Section 7. Handpiece Components For Your Information

7-1

7-1

Components of Assembled Handpieces Additional Handpiece Components

7-2

7-5

Section 8. Assembling the Handpiece in a Nonsterile Area For Your Information

8-1

8-1

Items Needed for Handpiece Assembly

8-2

Attaching the Tip to the Connecting Body Putting On the O-Rings

8-4

8-6

Clipping the Manifold Tubing to the Handpiece Cable (Optional) Packaging the Handpiece for Sterilization

8-6

8-7

Section 9. Sterilizing Handpieces and Accessories For Your Information

9-1

9-1

Sterilization Parameters

9-1

Sterilizing the Handpiece with Steam

9-3

Section 10. Completing Handpiece Setup in the Sterile Field For Your Information

10-1

Quick Reference – Setup

10-2

Completing the Handpiece Assembly

10-2

Section 11. Assembling or Changing Tips in the Sterile Field For Your Information

11-1

11-1

Items Needed to Change Tip in Sterile Field Assembling the Tip

10-1

11-2

11-5

Disassembling Handpiece to Change Tips in the Sterile Field Disassembling Handpiece After the Surgical Procedure Resterilizing the Handpiece

11-10

11-13

11-14

Resterilizing the Sterilizable Torque Base

11-14

Packaging the Handpiece for Sterilization

11-15

Packaging the Base for Sterilization Sterilize the Handpiece and Base

11-16 11-17

Section 12. Shutting Down, Disconnecting and Cleaning the Console 12-1 Shutting Down the System

12-2

Disconnecting Suction Tubing, Irrigation Tubing, and the Handpiece Cleaning the Console

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12-3

12-5

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Section 13. Disassembling and Cleaning Handpieces For Your Information

13-1

13-1

Disassembling the Handpiece Cleaning the Handpiece

13-2

13-4

Permitted Number of Reprocessing Cycles for Handpieces when Cleaned with an Automatic Washer 13-6 Cleaning the Tip Torquing Set

13-7

Section 14. Troubleshooting the System For Your Information

14-1

Responding to Alarms

14-2

General Troubleshooting

14-5

Section 15. Maintaining the System For Your Information Quick Reference

15-1

15-1

15-2

Handpiece Maintenance

15-3

Sterilizer Case Maintenance

15-4

Handling and Transporting of the System

15-4

Storage of the System and Accessories

15-5

Disposal of the Equipment

15-5

Return Equipment for Service Integra Service Centers

15-5

15-7

Appendix A. Technical Specifications Console Dimensions

A-1

Console Subsystems

A-2

Electrical Requirements Environment

A-1

A-3

A-4

Voluntary Standards Handpieces

14-1

A-5

A-11

Tip Specifications

A-11

Appendix B. Sterilization Validation Validation of Steam Sterilization Parameters

Appendix C. Warranty

B-1 B-1

C-1

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

List of Figures Figure 3-1.

Console – Front View 3-2

Figure 3-2.

Console Body – Front Panel 3-4

Figure 3-3.

Console Body – Side Panel 3-7

Figure 3-4.

Console Body – Rear Panel 3-9

Figure 3-5.

Console Body – Rear Panel Continued 3-10

Figure 4-1.

Control Panel for Excel8 and Excel9 models 4-2

Figure 4-2.

Control Panel for Excel and Excel 2 model 4-3

Figure 4-3.

Control Panel – Excel8 and Excel9 model (status indicators and setpoint adjustment) 4-6

Figure 4-4.

Control Panel – Excel and Excel 2 model (status indicators and setpoint adjustment) 4-7

Figure 5-1.

The assembled suction system 5-8

Figure 5-2.

The assembled irrigation system 5-10

Figure 7-1.

The components of a handpiece 7-2

Figure 7-2.

Tip torquing base and torque wrench for use when changing tips in the nonsterile field 7-5

Figure 7-3.

The sterilizable torque bases for use when changing tips in the sterile field 7-6

Figure 7-4.

The sterile torque wrench for use when changing tips in the sterile field 7-7

Figure 7-5.

The 23 kHz CUSA Excel/CUSA Excel+ handpiece sterilizer case 7-8

Figure 8-1.

The items you need to assemble a handpiece: handpiece, nosecone, and tip pack 8-2

Figure 8-2.

Tip torquing base and torque wrench (for use in non-sterile field) 8-3

Figure 8-3.

Manifold tubing 8-3

Figure 8-4.

The sterilizer case 8-7

Figure 8-5.

The handpiece and connector secured into the sterilizer tray 8-8

Figure 11-1.

The sterilized handpiece 11-2

Figure 11-2.

The sterilized standard nosecone 11-3

Figure 11-3.

Sterile tip/flue pack contents. The tip cleaner is inside the flue. 11-3

Figure 11-4.

Sterilizable tip torquing base 11-4

Figure 11-5.

Sterile torque wrench (23 kHz or 36 kHz) 11-4

Figure 11-6.

Sterile manifold tubing 11-4

Figure 11-7.

The handpiece and connector secured into the sterilizer tray 11-18

Figure 15-1.

Replacing o-ring on the handpiece connector water prongs 15-3

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Notes

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

SECTION

1

Patient and Operating Room Safety 1

In this section: • Indications for Use, page 1-1 • Intended Users, page 1-2 • Safety Information, page 1-2 • Warnings, Cautions, and Notices, page 1-3 • Classification and Console Symbols, page 1-9

Indications for Use The CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: •

Neurosurgery

•

Gastrointestinal and affiliated organ surgery

•

Urological surgery

•

Plastic and reconstructive surgery

•

General surgery

•

Orthopedic surgery

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Gynecological surgery

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Thoracic surgery

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

1-1

Intended Users

•

Laparoscopic surgery

•

Thoracoscopic surgery

Warning The CUSA Excel/CUSA Excel+ System cannot be used in an MRI (Magnetic Resonance Imaging) environment. Warning No modification of this equipment is allowed. Notice When you receive the CUSA Excel/CUSA Excel+ System and accessories, if any component is damaged, contact your Integra service representative for assistance. If the packaging for a sterile accessory is damaged, do not use the sterile accessory.

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 Excel/CUSA Excel+ System should only be used in a surgical environment by qualified medical professionals.

Warning It is the responsibility of the Healthcare Facility to ensure that intended users of CUSA Excel/CUSA Excel+ System are appropriately trained in the use of this equipment.

Safety Information The safe and effective use of ultrasonic surgery depends to a large degree on factors solely under the control of the operator. Only medical professionals that are properly trained in the use of ultrasonic equipment should operate the CUSA Excel/CUSA Excel+ System. It is important that medical professionals read, understand, and follow the operating instructions supplied with this equipment. Before starting any surgical procedure, medical professionals should be familiar with the medical literature, complications, and hazards of using ultrasonic surgery in that procedure.

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Warnings, Cautions, and Notices

Warnings, Cautions, and Notices To promote the safe use of the CUSA Excel/CUSA Excel+ System, this section presents the warnings, cautions, and notices that appear throughout this User’s Guide. To operate this equipment with maximum safety, it is important to read, understand, and follow the instructions in these warnings, cautions, and notices.

Patient and Operating Room Safety Warning The CUSA Excel/CUSA Excel+ System cannot be used in an MRI (Magnetic Resonance Imaging) environment. No modification of this equipment is allowed. It is the responsibility of the Healthcare Facility to ensure that intended users of CUSA Excel/CUSA Excel+ System are appropriately trained in the use of this equipment. Notice When you receive the CUSA Excel/CUSA Excel+ System and/or accessories, if any component is damaged, contact your Integra service representative for assistance.

Introduction to the System Warning Single Use devices are for single patient use only. Do not 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. Once used, devices must be disposed of in accordance with hospital policies. Only use Integra handpieces and accessories with the CUSA Excel/CUSA Excel+ System. Non-Integra handpieces and accessories are not supported. Caution Read the instructions, warnings, cautions, and notices provided with the CUSA Excel/CUSA Excel+ System before use. Otherwise injury to the patient or user or equipment damage may result.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

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Warnings, Cautions, and Notices

Console Components Warning Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to use the system may result in injury to the patient and/or surgical personnel, or equipment damage. To avoid injury to surgical personnel, keep fingers away from the suction pinch valve. TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. 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). When you connect the handpiece to the console, the handpiece becomes a functional surgical device.

Setting Up the System Warning When the handpiece is connected to a CUSA Excel/CUSA Excel+ 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. Inadvertent contact between handpiece accessories and the patient may result in burns. Do not use a damaged handpiece with the CUSA Excel/CUSA Excel+ System.This may result in injury to the patient or surgical personnel. Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to use the system may result in injury to the patient and/or surgical personnel, or equipment damage. To avoid injury to surgical personnel: When closing the irrigation pump latch, keep fingers away from the area between the V-shaped tubing retainers. If the pump latch is open, keep fingers away from the pump rollers. To avoid injury to surgical personnel, keep fingers away from the suction pinch valve. When you connect the handpiece to the console, the handpiece becomes a functional surgical device. The handpiece and handpiece accessories must be sterile before surgical use.

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Warnings, Cautions, and Notices

Warning 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 of the handpiece and require replacement before use. CUSA Excel 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. Excessive loading of CUSA Excel tips at the surgical site can induce heating due to vibration and acoustic power transmissions. Thermal management of the surgical site with the aid of the appropriate irrigation and aspiration settings is essential. Avoid excessive lateral loading of CUSA Excel tips. Avoid contacting bone with the CUSA Excel tips (excluding SaberTip™).

Caution When you test the handpiece, do not allow the handpiece tip to contact anyone or anything during tip activation. Contact may result in patient injury, user injury, or handpiece tip damage. During surgery, under maximum loading conditions, the CUSA Excel/CUSA Excel+ console is suitable for ultrasonics activation times of 10 minutes on, 5 minutes off. Sharp edge at the handpiece connection point. Make sure that the irrigation tubing centers between the V-shaped tubing retainers before you close the pump latch. Otherwise, the pump latch will pinch the tubing, preventing the flow of irrigation fluid. Before surgery, apply the brakes locks to all wheels on the console to stop the wheels from rolling. Notice To prevent fluid flowing into the vacuum line, only use a canister that has a nonreturn valve. During surgery, do not allow the handpiece tip to touch metal objects such as staples, clips, instruments, etc. Handpiece tip damage will result.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

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Warnings, Cautions, and Notices

Using the Console Controls Warning Ignoring alarms on the CUSA Excel/CUSA Excel+ System while continuing to use the system may result in injury to the patient and/or surgical personnel, or equipment damage.

Handpiece Components Warning Do not use the sterile wrench for more than one surgical procedure.

Assembling the Handpiece in a Nonsterile Area Warning Turning the torque wrench further clockwise will damage the handpiece. Caution Do not assemble the nonecone to the handpiece until you have sterilized the handpiece. To avoid product damage, NEVER hold the handpiece in your hand while using the torque wrench to tighten or loosen the tip. Notice Do not sterilize the C5600 tip torquing base or the associated the torque wrench because it destroys the lubrication in the torquing mechanism, resulting in product damage.

Completing Handpiece Setup in the Sterile Field Notice Retaining a spare handpiece in the sterile field is highly recommended.

Assembling or Changing Tips in the Sterile Field Warning The handpiece and handpiece accessories must be sterile before surgical use. Before use, sterilize the sterilizable torque base in the sterilizer tray. Turning the torque wrench further clockwise will damage the handpiece. Caution To avoid product damage, NEVER hold the handpiece in your hand while using the torque wrench to tighten or loosen the tip.

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CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

Warnings, Cautions, and Notices

Shutting Down, Disconnecting and Cleaning the System Warning Electric Shock Hazard – Always unplug the CUSA Excel/CUSA Excel+ System before cleaning it. Sharp edge at the handpiece connection point. Notice Do not disconnect the handpiece until the control panel goes completely blank. Otherwise, product damage may result. Do not rub, press, or touch any panels with solvents; caustic, corrosive, or abrasive cleaning or disinfectant compounds, or other materials that could scratch the panels. Do not use a betadine-based solution because it will cause discoloration. Do not allow fluids to enter the console.

Disassembling Handpieces Caution To avoid product damage, NEVER hold the handpiece in your hand while using the torque wrench to tighten or loosen the tip. 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 washers Do not use chlorinated substances such as bleach solution Do not clean the handpiece with abrasives such as Ajax®, Comet®, or steel wool Product damage will result if you do not follow these notices when cleaning the Tip Torquing Set: Do not use ultrasonic washers Do not autoclave Do not use chlorinated substances such as bleach solution Do not clean with abrasives such as Ajax, Comet, or steel wool

Maintaining the System Notice Do not clean the sterilizer case with abrasives. Product damage will result. To avoid product damage, use proper packaging materials and packing procedures when preparing the console for shipment. Failure to return product in this manner may void the warranty and/or damage the product. Contact Integra for details.

CUSA® Excel/CUSA® Excel+ Ultrasonic Surgical Aspirator System User’s Guide

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