CUSA Clarity Operators Manual Rev F May 2018

CUSA Clarity Ultrasonic Surgical Aspirator System ®

Operator’s Manual

Table of Contents

Table of Contents PREFACE Intended Audience... ix Trademark Acknowledgments... ix Manufacturer...x Patent Information...x Overview of Manual...x System Features... xi Intended Uses... xi Conventions Used in this Guide... xi

SECTION 1 Patient and Operating Room Safety Indications for Use... 1-1 Intended Users... 1-2 Safety Information... 1-2 Warnings and Cautions... 1-3 Patient and Operating Room Safety... 1-3 Classification and Console Symbols... 1-9

SECTION 2 Introduction to the System Overview... 2-1 CUSA® Clarity System... 2-2 Fragmentation... 2-4 Irrigation... 2-4 Aspiration (Suction)... 2-5 Touchscreen Display... 2-6 Handpiece... 2-6 Handpiece Functions... 2-6 Handpiece Configurations... 2-7 Handpiece Tips... 2-7 Tissue Select® Feature... 2-7 Sterilization of Handpieces and Accessories...2-11

SECTION 3 Console Components

Overview... 3-1 Console Features... 3-2 Console – Front Panel... 3-4 Console – Rear Panel... 3-5

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SECTION 4 Touchscreen Display and Functions Overview... 4-1 Touchscreen Layout... 4-1 Main Screen... 4-2 Setup Tasks Screen... 4-3 Settings Screen... 4-3 Online Help... 4-4 Alarm Indicators... 4-4 Ultrasonic Control Scale Adjustments... 4-5 Adjusting the Ultrasonic Control Scale Values... 4-5 Footswitch and Aspiration Modes... 4-6 Footswitch Mode... 4-6 Aspiration Mode... 4-7

SECTION 5 Handpiece Components Overview... 5-1 Components of Assembled Handpieces... 5-2 Handpiece... 5-2 Tip... 5-3 Nosecone... 5-3 Flue... 5-4 Additional Handpiece Components... 5-4 CUSA Quick Connect™ Cartridge and Tubing Set (Sterile)... 5-4 Aspiration Tubing... 5-5 Irrigation Tubing... 5-5 Cartridge... 5-5 Single-Use Torque Wrench (Sterile)... 5-5 Torque Base (Sterilizable)... 5-6

SECTION 6 Assembling the System Prior to Use Overview... 6-1 Assembling the Console and Cart... 6-2 Attaching the Power Cord... 6-3

SECTION 7 System Setup in the Sterile Field Overview... 7-1 Quick Reference: Setting Up in the Sterile Field... 7-2 Assembling the Handpiece in the Sterile Field... 7-3 Attaching a Tip... 7-3 Attaching the Nosecone and the Flue... 7-5 Attaching the Tubing... 7-7

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Table of Contents

SECTION 8 System Setup in the Non-Sterile Field Overview... 8-1 Quick Reference: Setting Up in the Non-Sterile Field... 8-1 Assembling the Handpiece... 8-2 Console Setup (Non-Sterile)... 8-2 Powering Up the System... 8-2 Attaching the Footswitch... 8-3 Attaching the Handpiece... 8-3 Connecting the Tubing Set... 8-4

SECTION 9 Operating the System Overview... 9-1 Quick Reference: Operating the System... 9-2 Priming the System... 9-2 Start Prime... 9-2 Stop Prime... 9-3 Testing the Handpiece... 9-4 Start Test... 9-4 Detailed Test Results... 9-5 System Ready for Use... 9-5

SECTION 10 Changing Tips in the Sterile Field During a Surgical Procedure Overview... 10-1 Quick Reference: Changing Tips... 10-1 Changing a Tip... 10-2 Removing the Used Tip... 10-2 Assembling the New Tip on the Handpiece... 10-6

SECTION 11 Disassembling, Cleaning, and Sterilizing the System Overview...11-1 Quick Reference: Disassembling the System...11-1 Quick Reference: Cleaning the System...11-2 Disassembling the System...11-2 Which CUSA® Clarity Items to Keep and Discard After a Surgical Procedure...11-2 Disassembling the Handpiece...11-2 Disassembling the Console...11-7 Detaching the Contamination Guard...11-10 Powering Down the System...11-10 Cleaning the System... 11-11 Cleaning the Touchscreen... 11-11 Cleaning the Console and Cart... 11-11 Cleaning the Handpiece, EUT, and Torque Base...11-12 Cleaning the Footswitch...11-13 Sterilization Tray Cleaning...11-13 CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

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Sterilizing the System...11-14 Packaging the Handpiece and Components for Sterilization...11-14 Sterilization Parameters...11-16 Sterilization Tray Packaging...11-16 Sterilizing the Handpiece and Components with Steam...11-17

SECTION 12 Maintaining the System Overview... 12-1 Quick Reference... 12-2 Handpiece Maintenance... 12-2 Return and Replace the Handpiece... 12-2 Handling and Transporting of the System... 12-3 Storage of the System and Accessories... 12-3 Console... 12-3 Console with Cart... 12-3 Handpiece... 12-4 Footswitch... 12-4 Disposal of the Equipment... 12-4 Return Equipment for Service... 12-4 Obtaining a Return Authorization Number... 12-4 Returning the Console... 12-5 Returning the Handpiece... 12-5 Ordering Replacement Parts... 12-5 Integra Service Centers... 12-6 US Service Center... 12-6 Europe, Middle East and Africa Service Center... 12-6 Asia Pacific Service Center... 12-6

SECTION 13 Troubleshooting the System Overview... 13-1 Extracting Log Files... 13-2 Alarm Descriptions... 13-2 Technical Messages... 13-3 Amplitude Troubleshooting... 13-3 Aspiration Troubleshooting... 13-5 Irrigation Troubleshooting... 13-5

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Table of Contents

SECTION 14 MR Safety Information Overview... 14-1 Use of the CUSA Clarity System in the MR environment... 14-2

SECTION A Technical Specifications Console... A-1 Dimensions... A-1 Tip Specifications... A-2 Subsystems... A-3 Handpiece... A-3 Dimensions... A-3 Frequency... A-3 Electrical Requirements... A-4 Power Input and Fusing... A-4 Power Cords... A-4 Maximum Low Frequency Leakage... A-5 Duty Cycle... A-5 Electromagnetic Interference... A-5 Environment... A-5 Operating... A-5 Storage and Shipping... A-5 Voluntary Standards... A-6 Statutory and Regulatory Classification... A-6 EMC Compatibility... A-6 Guidance and Manufacturer’s Declarations... A-7

SECTION B Warranty Warranty... B-1 Coverage... B-1 Exclusions... B-1 Service, Repairs and Replacement... B-2 Service and Repairs... B-2 Equipment Replacement... B-2 Notification... B-2 Repair Parts and Services... B-2 Consoles... B-2 Handpieces... B-2 Modifications to Covered Equipment... B-3 Quality Control... B-3 Limitations of Liability... B-3

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CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

PREFACE

Intended Audience This operator’s 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® Clarity Ultrasonic Surgical Aspirator System only.

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

Trademark Acknowledgments Integra, the Integra logo, CUSA, and Tissue Select are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ShearTip, MicroTip, and CUSA Quick Connect are trademarks of Integra LifeSciences Corporation or its subsidiaries. Sani-Cloth is a trademark of Professional Disposables International, Inc. neodisher is a trademark of Chemische Fabrik Dr. Weigert GmbH & Co. KG. All other trademarks and trade names are the property of their respective owners.

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Preface

Manufacturer Integra LifeSciences (Ireland) Limited IDA Business & Technology Park Sragh Tullamore, County Offaly, Ireland Integra LifeSciences Corporation Plainsboro, NJ 08536 USA; 1-800-997-4868 © 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 6,499,358; 8,118,823; 8,518,066; 9,421,027; D796,667; D819,195; additional patent(s) pending

Overview of Manual This operator’s manual describes how to use the CUSA Clarity Ultrasonic Surgical Aspirator System. It presents the CUSA Clarity as a system that includes a console, handpieces, and accessories. It describes:

x

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The system and its functions

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The console, its subsystems, and its components

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The handpiece and its components

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How to setup and use the console

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How to assemble and use the handpiece with the system

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How to disassemble the handpiece

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How to clean components of the system

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How to sterilize components of the system

CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

Preface

System Features

The CUSA Clarity system includes several important components and features: •

Console with touchscreen interface

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Cart

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36 kHz handpiece

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A variety of surgical tips that attach to the handpiece:

•

•

Sterile, single-use tips

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Non-sterile, extended use tips (EUT)

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

Intended Uses of this Manual

When you receive your CUSA Clarity system, we recommend that you read and understand all of this operator’s manual before using the system. Also, use the manual for: •

Reference - When you need specific information on a task.

•

Training - When training new personnel to use the system.

Conventions Used in this Guide To draw immediate attention to matters of importance, this manual presents Warnings, Cautions, and Notes

WARNING Indicates a potentially hazardous situation that, if not avoided, could result in serious injury or death.

CAUTION Indicates a hazardous situation that, if not avoided, could result in product damage.

NOTE Indicates additional information.

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CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

SECTION 1 Patient and Operating Room Safety

In this section: •

Indications for Use, page 1-1

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Contraindications, page 1-2

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Safety Information, page 1-2

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Warnings and Cautions, page 1-3

•

Classification and Console Symbols, page 1-9

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

 eurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, N Gynecological Surgery and Thoracic Surgery and the following specific uses: •

 astrointestinal and Affiliated Organ Surgery - including removal of G benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy.

•

 rological surgery - including removal of renal parenchyma during U nephrectomy or partial nephrectomy.

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 eneral Surgery - including removal of benign or malignant tumors or G other unwanted soft tissue in open or minimally invasive general surgical procedures.

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Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.

Contraindications

Contraindication This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

Intended Users You should use the CUSA Clarity system only in a surgical environment by qualified medical professionals trained in the use of this equipment. This system must be set up/disassembled by operating room (OR) staff (for example, surgical nurse, neuro technician). The OR staff is also likely to operate the device controls. The handpiece and footswitch are controlled by the surgeon.

WARNING It is the responsibility of the Healthcare Facility to ensure that intended users of the CUSA Clarity 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 Clarity 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® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

Warnings and Cautions

Warnings and Cautions To promote the safe use of the CUSA Clarity system, this section lists the warnings and cautions that appear throughout this operator’s manual. To operate this equipment with maximum safety, it is important to read, understand, and follow the instructions in these warning and cautions.

Patient and Operating Room Safety WARNING The CUSA Clarity Ultrasonic Surgical Aspirator System, including all accessories and components, is MR Unsafe. It must not be brought into the MR environment.

WARNING Operating the CUSA Clarity system outside of the specified environmental conditions may result in injury to the patient and/or user, or equipment damage, which may result in a delay in patient treatment.

WARNING No modification of this equipment is allowed.

WARNING Single-use devices are for single patient use only. Do not reprocess or re-use.

WARNING Ignoring alarms on the CUSA Clarity system while continuing to use the system may result in injury to the patient and/or user, or equipment damage.

WARNING To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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Warnings and Cautions

WARNING When the handpiece is connected to a CUSA Clarity 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.

WARNING When the handpiece is powered on, contact of the tip with a hard surface (for example: a metal instrument, tray, staples, clips, instruments, and so on) may damage the tip of the handpiece.

WARNING Do not use a damaged handpiece with the CUSA Clarity system. This may result in injury to the patient or user.

WARNING The handpiece and handpiece accessories (tip, flue, stylet and nosecone) must be sterile before surgical use.

WARNING To avoid injury to the user, keep fingers away from the peristaltic pump and pinch valve.

WARNING Touching the tip of the handpiece by the user, while the handpiece is powered on, may result in personal injury.

WARNING To avoid injury or damage to equipment, place system in standby prior to changing tip or clearing a clog.

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CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

Warnings and Cautions

WARNING Potential Burn Hazard - CUSA Clarity tips utilize a silicone flue. Compressing the flue against the side of the vibrating surface along the length of the tip may cause excessive heating, which may burn the adjacent tissue of the surgical site.

WARNING Excessive loading of CUSA Clarity tips at the surgical site may 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.

WARNING If the aspiration tubing and contamination guard are not connected to the correct canister ports, the system may not work.

WARNING Avoid excessive lateral loading of CUSA Clarity tips. This may result in injury to the patient and/or user, or equipment damage.

WARNING Avoid contacting bone with the CUSA Clarity tips.

WARNING Do not use the sterile torque wrench for more than one surgical procedure. Reprocessing may damage the torque wrench.

WARNING Before use, sterilize the torque base in the sterilization tray with the handpiece.

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Warnings and Cautions

WARNING Explosion Hazard - Do not use the CUSA Clarity system in the presence of flammable anesthetics or other volatile solvents.

WARNING Electric Shock Hazard - Always unplug the CUSA Clarity system before cleaning it.

WARNING Electrical Shock Hazard - Do not remove cover. Refer servicing to authorized service personnel.

WARNING The minimum aspiration level setting is 10%. This ensures proper handpiece cooling and performance. Insufficient aspiration may cause premature handpiece or tip failures and may induce heat exchange with the patient or user, and cause tissue burns.

WARNING For continued protection against fire and electrical hazard, replace fuse only with same type and rating. Refer to “Power Input and Fusing” on page A-4.

WARNING Do not allow fluids to enter the console.

WARNING When testing the handpiece, do not allow the tip to come in contact with any person or object during tip activation. Contact may result in injury to the patient and/or user, or handpiece tip damage. Contact with any object or person may cause the test to fail.

WARNING Do not power up the handpiece without performing a prime cycle (that is, irrigation fluid must flow from the distal 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 and/or user, and cause tissue burns. 1-6

CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual

Warnings and Cautions

WARNING If the packaging for a sterile accessory is damaged, do not use the sterile accessory.

WARNING To ensure sterility, assemble sterile handpiece and tip in the sterile field only.

CAUTION Read the instructions, warnings, cautions, and notes provided with the CUSA Clarity system before use; otherwise, injury to the patient and/or user, or equipment damage may result.

CAUTION During surgery, under maximum loading conditions, CUSA Clarity system has an ultrasonic duty cycle of 10 minutes on, 5 minutes off.

CAUTION Before surgery, apply the brake locks to all wheels on the cart (if using the optional Integra cart) to stop the wheels from rolling.

CAUTION When using the console without a cart, prior to surgery, place the console on a solid surface. The surface must be flat, non-slip, and free from obstruction.

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Warnings and Cautions

CAUTION To avoid product damage, always use the torque base to hold the handpiece while using the torque wrench to tighten or loosen the tip. Avoid over torqueing the tip.

CAUTION Do not use sterilization methods involving temperatures in excess of 134ºC as this may damage the handpiece.

CAUTION Product damage may result if you do not follow the instructions described in the cleaning section.

CAUTION To move the console up or down a ramp, use two or more people.

CAUTION High frequency surgical equipment can affect the function of medical electrical devices such as ultrasonic aspirators. When using monopolar high frequency surgical equipment simultaneously with the CUSA Clarity system, contact between the activated monopolar electrosurgery instrument and the CUSA Clarity surgical tip could affect system functionality. Avoid contact between the CUSA Clarity surgical tip and an activated monopolar surgical instrument.

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CUSA® Clarity Ultrasonic Surgical Aspirator System Operator’s Manual