CUSA NXT Operators Manual Issue E

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

CUSA® NXT Operator’s Manual Integra Part Number: 72904051 Rev. E Effective Date: January 2018 Trademark Acknowledgements:

Integra, the Integra logo, CUSA and Selector are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. SaberTip and MicroTip are trademarks of Integra LifeSciences Corporation or its subsidiaries. Bemis and Hi-Flow are trademarks of Bemis Manufacturing Company. Cidex and Nu-Cidex are trademarks of Johnson & Johnson. Hibicet and Hibitane are trademarks of Regent Medical Limited. RECEPTAL is a trademark of Hospira, Inc. Copyright Information:

Integra LifeSciences Corporation. All Rights Reserved. 0086 ©No2018 part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means - electronic, mechanical, photocopying, recording, or otherwise - without the expressed, written consent of Integra LifeSciences. Additional copies of this document can be ordered from Integra LifeSciences. Integra LifeSciences (Ireland) Limited. IDA Business & Technology Park Sragh Tullamore County Offaly Ireland www.integralife.com

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TABLE OF CONTENTS

Chapter 1: Patient and Operating Room Safety System Overview ...1 Intended Use ...1 Contraindications ...1 Intended Users ...2 Warnings, Cautions and Notices ...3 Patient and Operating Room Safety ...3 CUSA NXT System Setup and Components...3 Using the Console, Service Module, and Handpieces ...5 Preparing the CUSA NXT System for Surgery ...6 Operating the CUSA NXT System During Surgery ...8 Disassembly and Sterilization of CUSA NXT System ...8 Use of System in MRI Environments ...9 Troubleshooting the CUSA NXT System...10 Technical Specifications ...10 Classification and System Symbols ...10 Tubing Pathway Symbols ...14 Footswitch Symbols...16

Chapter 2: CUSA® NXT System Setup and Components Unpacking and Installing the System ...17 Commissioning the System ...18 Initial Setup of Console with the Service Module ...19 List of CUSA NXT Components ...20 About the Console ...20 About the Footswitch ...21 About the Service Module ...21 About the Handpieces and Wrench Sets ...23 Handpieces...23 Wrench Sets ...23 About the Tubing Kits ...24 About the Sterile and Non-Sterile Tips ...25 For Neuro Handpieces ...25 For Standard Handpieces...26 Summary of Operating Safety Precautions ...27

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Using the Handpieces... 27 Sterilizing Backup Handpieces ... 28 Warnings and Hazards when Using the System... 28 Requirements for Servicing the System... 31 Explosion and Fire Hazards... 31 Latex Information ... 31

Chapter 3: Using the Console, Service Module, and Handpieces About the Console Functionality ... 33 About the Left Console Panel ... 34 About the Rear Console Panel ... 35 Connecting Handpieces to the Console... 36 Using the Footswitch Pedals ... 36 Using the Touch Screen Monitor ... 38 Status/Alarm Symbols... 39 Adjusting the Ultrasonic Control Scales... 41 Verifying General Ultrasonic Information ... 43 Displaying Menus for Prime Mode, Customized Settings, and Online Help ... 44 About the Service Module Functionality ... 44 About the Handpiece Functionality... 47 List of Handpieces ... 47 List of Standard Handpieces... 48 List of Neurosurgical Handpieces ... 50 List of MicroSurgical Handpieces... 54

Chapter 4: Preparing the CUSA® NXT System for Surgery List of Requirements... 55 Assembling the Handpieces ... 56 Preparing the System ... 59 Prepare the Suction Source... 59 Prepare the IV Bag ... 60 Prepare the Tubing Kits ... 60 Connect Tubing to Console ... 62 Position the Footswitch ... 63 Priming the Handpieces ... 63 Testing the Alarm Tone ... 65

Chapter 5: Operating the CUSA® NXT System During Surgery Operating the System During Surgery... 67

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Warnings Relating to the Tips During Surgery ...69 Customizing the User Settings ...70

Chapter 6: Disassembly and Sterilization of CUSA® NXT System Dismantling the System After Surgery ...73 Cleaning the Handpieces After Surgery ...75 Disassembling the Handpieces ...75 Sterilizing Components and Maintaining the Handpieces ...77 Recommended Sterilization Procedures ...77 Disinfecting the Handpieces ...78 Maintaining the Handpieces ...79 Maintaining the Touch Screen Monitor ...80 Safety Guidelines ...80 Cleaning Guidelines ...80 Handling and Transporting the System ...81 Console with Service Module ...81 Console without Service Module ...81 Shipping Instructions ...82

Chapter 7: Troubleshooting the CUSA® NXT System About the Troubleshooting Process ...83 Problems Powering the System On and Off ...83 Responding to Alarms ...84 Troubleshooting Aspiration Problems ...85 Troubleshooting Irrigation Problems ...86 Troubleshooting Ultrasonic Power Problems ...87

Appendix A: Technical Specifications Specifications for the CUSA® NXT System...89 Electrical Safety ...91 Standards and IEC Classifications ...93 Manufacturer’s Declaration Table ...94

Appendix B: Warranty Integra Warranty for the CUSA® NXT Ultrasonic Surgical Aspirator...99

Index ... 103

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CHAPTER 1

PATIENT AND OPERATING ROOM SAFETY

System Overview ... 1 Intended Users... 2 Warnings, Cautions and Notices... 3 Classification and System Symbols ... 10

System Overview The CUSA® NXT Ultrasonic Surgical Aspirator System facilitates the removal of tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration.

Intended Use The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) 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. Using this System in Ultrasonic Surgery The basic operating principle of ultrasonic surgery involves the longitudinal vibration of the hollow handpiece tip at ultrasonic frequency against tissue. The mechanical action of the tip is similar to a tiny “surgical hammer” that breaks off cellular material. When the tip contacts the fluid filled tissue, the resulting slurry of emulsified material from the tissue is aspirated through the center of the handpiece. A slow flow of irrigant around the tip assists in the removal of waste tissue. The selective action of the instrument arises from the disruption of fluid containing cellular material while fibrous and elastic tissue such as nerves and blood vessels remain relatively unaffected at the ultrasonic frequencies used. Warning No modification of this equipment is allowed.

Contraindications This device is not indicated for and should not be used for the removal of uterine fibroids.

Chapter 1 • Patient and Operating Room Safety • 1

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 NXT System should only be used in a surgical environment by qualified medical professionals.

Warning The Console is only to be used in a hospital environment and by qualified operators and surgeons. Failure to observe this warning could result in serious injury or death. It is the responsibility of the Healthcare Facility to ensure that intended users of CUSA NXT System are appropriately trained in the use of this equipment.

Reviewing the Operator’s Manual Verify that all surgeons, nurses, and technicians who will be setting up, operating and maintaining the CUSA NXT System review this Operator’s Manual prior to using the system in a surgical procedure. Pay close attention to the operating safety warning, cautions and notices listed in the section Warnings, Cautions and Notices, p. 3. If there are additional questions after reading this manual, contact the technical support staff at Integra LifeSciences. To draw immediate attention to matters of importance, this guide presents warnings, cautions and notices as follows:

Warning

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

Online Help On the touch screen monitor, press the help button to display the online help system. Please note that the online help system only provides basic guidelines for performing common CUSA NXT tasks. The online help does not: •

Replace this Operator’s Manual.

•

Provide clinical instructions for any specific procedures.

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For complete instructions on using the CUSA NXT System, refer to the procedures described in this Operator’s Manual.

Warnings, Cautions and Notices To promote the safe use of the CUSA NXT System, this section presents the warnings, cautions, and notices that appear throughout this guide.To operate this equipment with maximum safety, it is important that you read, understand and follow the instructions in the warnings, cautions, and notices.

Patient and Operating Room Safety Warning

No modification of this equipment is allowed. The Console is only to be used in a hospital environment and by qualified operators and surgeons. Failure to observe this warning could result in serious injury or death. It is the responsibility of the Healthcare Facility to ensure that intended users of CUSA NXT System are appropriately trained in the use of this equipment.

CUSA NXT System Setup and Components Warning

Only operate the footswitch when the base of the footswitch is positioned flat on the ground, and the front of the footswitch is facing upwards with the pedals visible and free from obstruction. TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. Only use Integra handpieces and accessories with the CUSA NXT System. The use of non-Integra handpieces or accessories may result in patient injury. Non-Integra handpieces or accessories are not supported and are not covered by warranty. When you connect the handpiece to the Console, the handpiece becomes a functional surgical device. When the handpiece is connected to a CUSA NXT 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, non-conductive, and highly visible surface.

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Warning

When pressing the Power Footswitch pedal to operate the handpiece, do not allow the tip of the handpiece to come into contact with any object except for the target tissue at the operating site. Touching the tip while powered can result in personal injury. The handpiece and handpiece accessories must be sterile before surgical use. Risk of explosion. Do not use in the presence of flammable anaesthetic gases or other volatile solvents. • Electrical shock hazard. Do not remove cover. • Refer servicing to authorized service personnel. To avoid personal injury or damage to the tip, do not allow the tip of the handpiece to contact any operator or hard surfaces or anything other than the target tissue when powered. For continued protection against fire and electrical hazard, replace fuse only with same type and rating. Do not use a damaged handpiece with the CUSA NXT System.This may result in injury to the patient or surgical personnel. A damaged handpiece must be returned to the manufacturer for repair. Do not attempt to dismantle the rear handle sections of the handpieces; it does not contain any serviceable parts. Use of the handpiece outside of the specified conditions can result in high operating temperatures. Contact between the unprotected part of the tip and non-target tissue can result in burns. Use of the handpieces in a damaged condition can result in an electric shock hazard. Failure to maintain the CUSA NXT System in accordance with the instructions in this manual can compromise safety. Use the single use CUSA® Selector® tubing, and single use tips and flue sets once only. Re-use may result in a biological hazard. Use single use tips for a single procedure only. Re-using single use tips may result in tip fragmentation and injure the patient or user.

Caution If the packaging for a sterile accessory is damaged, do not use the sterile accessory. Contact of the moving tip against a hard surface, e.g. a metal instrument tray, may damage the tip of the handpiece and require replacing the tip before use. Do not use a handpiece with a broken tip.

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Caution Only use the CUSA Selector wrench kit to tighten tips and extensions on the transducer of the handpiece. Always secure the handle of the handpiece in the holder provided. Never dismantle or assemble the handpiece without placing the handle section of the handpiece in the holder. Failure to comply with this instruction could result in permanent damage to the transducer and will invalidate the warranty. Do not attempt to clear a blocked handpiece by passing the stylet down the rear inlet of the handpiece. This may result in damage to the handpiece. Always pass the stylet from the tip end. Do not use a handpiece with a broken tip. Inspect the tip for damage prior to use. If the tip is damaged it may be replaced by the operator. Do not use dry air sterilization methods involving temperatures in excess of 139 °C (282 °F); this may damage the handpiece. Do not power up the CUSA Selector handpiece without fully priming the handpiece with irrigant (i.e. irrigant must flow from the 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 or user, and cause tissue burns.

Notice

In the event that you need to return a device to Integra, to prevent any damage, use the appropriate packaging material. To prevent fluid flowing into the vacuum line, only use a canister that has a non return valve.

Using the Console, Service Module, and Handpieces Warning

When you connect the handpiece to the Console, the handpiece becomes a functional surgical device. Ignoring alarms on the CUSA NXT System while continuing to use the system may result in injury to the patient and/or surgical personnel, or equipment damage. The minimum aspiration level setting is 15%. This ensures proper handpiece cooling and performance. Insufficient aspiration can cause premature handpiece or tip failures and may induce heat exchange with the patient or user, and cause tissue burns.

Chapter 1 • Patient and Operating Room Safety • 5

Caution Pressing and releasing the Power pedal too quickly may result in a Handpiece Tip Initialization failure. If this occurs, disconnect the handpiece, verify proper tip assembly, and then reconnect the handpiece and try again. Do not store anything in the storage area in the back of the Console while the system is running.

Notice After releasing the Power pedal, the pinch valve operates momentarily to block aspiration and facilitate tissue release from the handpiece tip. If you press the yellow symbol, the touch screen monitor will display error and problem resolution information. For more information on responding to alarms, see page 84. The level of ultrasonic power displayed on the scale will only be directed to the handpiece tip when the power Footswitch pedal is pressed fully. Pressing this Footswitch pedal partially will give an actual power output below the setting displayed with the exact value depending on the pedal position. Note that the system only delivers irrigant to the handpiece tip when you press the Power Footswitch pedal. When you press the Fast Flush Footswitch pedal, the system ignores the irrigation scale setting and instead applies an irrigation fast flush rate of about 50 ml/min to the handpiece. Only the Console is shipped with a power cord. If a Service Module is employed, this cord must be used for the Service Module instead. A lead comes from the rear door of the Service Module and plugs into the back of the Console.

Preparing the CUSA NXT System for Surgery Warning Single Use devices are for single patient use only. Do not resterilize, 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. Do not use devices which have not been properly sterilized. Once used, devices must be disposed of in accordance with hospital policies. Using the incorrect wrench set to assemble/disassemble the handpiece may damage the handpiece. Failure to center the shroud may cause the handpiece to overheat.

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Warning Tubing kits must never be connected directly to the vacuum source as contamination will occur. To avoid injury to surgical personnel, keep fingers away from the pump rollers.

Caution With correct use of the wrench, it is not possible to over tighten the joint. However, if the joint is not firmly tightened, the handpiece will not function correctly and may be noisy and overheat during use. Do not power the CUSA Selector handpiece without fully priming the handpiece with irrigant, i.e. irrigant must flow from the tip of the handpiece. Failure to follow this instruction may result in permanent damage to the handpiece (internal and/or external components) and may induce heat exchange with the patient or user, and cause tissue burns. When using the Console without the Service Module, prior to surgery, place the Console on a solid surface. The surface must be flat, non-slip and free from obstruction. The manifold tubing utilizes PVC tubing which is known to contain DEHP in a portion of the drainage path. The risk of exposure to pregnant (breast feeding) women, children and peri-pubescent males is not considered significant for the following reason(s): Saline solution running through the tubing, as irrigation, comes into contact with the surgery site during the tissue ablation process. However, the saline is rapidly aspirated back into the tip along with the ablated tissue.

Notice If you are using either a straight or laparoscopic handpiece, the angled extension is not required. Write the in-service start date on the contamination guard label before you install it. See page 79 for details on the contamination guard shelf life. All of the handpiece and tubing kit components in the CUSA NXT System are not manufactured with dry natural rubber or natural rubber latex. When preparing the tubing set, connect the tubing to the pump prior to attaching the irrigation supply. Attaching the irrigation supply first will fill the tube with saline and affect the priming time. Do not remove the aspiration filter from the designated port prior to powering off the system.

Chapter 1 • Patient and Operating Room Safety • 7

Operating the CUSA NXT System During Surgery Warning

The handpiece and handpiece accessories must be sterile before surgical use. 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 and require replacement before use. CUSA NXT tips utilize a silicone flue. Compressing the flue against the side of the vibrating surface along the length of the tip can cause excessive heating and potential burns along the surgical path. Excessive loading of CUSA NXT tips at the surgical site can induce heating due to vibration and acoustic power transmissions into adjacent tissue that may not be easily visualized due to anatomical constraints. Thermal management of the surgical site with the aid of the appropriate irrigation and aspiration settings is essential. Avoid excessive lateral loading of CUSA NXT tips This may result in equipment damage and/or injury to the patient or surgical personnel. Ignoring alarms on the CUSA NXT System while continuing to use the system may result in injury to the patient and/or surgical personnel, or equipment damage.

Caution Before surgery, apply the brakes locks to all wheels on the Service Module to stop the wheels from rolling. Do not attempt to clear a blocked handpiece by passing the stylet down the rear inlet of the handpiece. This may result in damage to the handpiece. Always pass the stylet in from the tip end.

Notice Press the Power pedal prior to applying the tip of the handpiece to tissue. This will ensure that the tip is vibrating before load is applied.

Disassembly and Sterilization of CUSA NXT System Warning

To avoid injury to surgical personnel, keep fingers away from the pump rollers.

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Warning

Electric Shock Hazard – Always unplug the CUSA NXT System before cleaning it. Do not allow fluids to enter the Console or Service Module.

Caution Validation of the steam cycles described have been conducted, however, it is solely the decision of the hospital to approve the use of these cycles.

Notice Do not remove the aspiration filter from the designated port prior to powering off the system. Do not re-use the tubing kit as this compromises sterility and may lead to damage of the Console and/or Service Module. Do not remove the contamination guard situated in the receptacle bay at the front of the Service Module. When dismantling and assembling handpieces of different operating frequencies (24 kHz or 35 kHz), care should be taken to ensure that the correct tips are fitted to the correct handle section. This is achieved by following the color coding, bronze for 24 kHz and gold for 35 kHz. Incorrectly fitted handpieces will either be non-functional or may not perform as intended. If you are using either a straight or laparoscopic handpiece, the angled extension is not required. 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 or automatic washers.

•

Do not use chlorinated substances such as bleach solution.

•

Do not clean the handpiece with abrasive cleaners or steel wire wool.

Use of System in MRI Environments Warning The CUSA NXT System cannot be used in an MRI (Magnetic Resonance Imaging) environment.

Chapter 1 • Patient and Operating Room Safety • 9

Troubleshooting the CUSA NXT System Notice If you press the yellow symbol, the touch screen monitor will display error and problem resolution information.

Technical Specifications Warning

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). TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. Operating the CUSA NXT outside of the specified environmental conditions may result in injury to the patient and/or surgical personnel, or cause damage to the equipment which may result in a delay in patient treatment.

Classification and System Symbols The following symbols appear on the CUSA NXT System: Symbol

Description

Warning: When you connect the handpiece to the Console, the handpiece becomes a functional surgical device.

Warning: Dangerous voltage.

Follow instructions for use

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Symbol

Description

Do not insert fingers. Pinch point can cause injury.

While the Console is connected to the Service Module, do not push, lean or rest against the front or sides of the Console. Only use the Service Module handle when moving the Console.

Protective Earth (ground)

Footswitch Connector

The equipment meets type CF (Cardiac Floating) safety standards.

VOLUME

Volume Control: Controls the volume of non-alarm tones emitted by the Console.

Equipotential point

Alternating current

"On" power

"Off" power

Chapter 1 • Patient and Operating Room Safety • 11

Symbol

Description

System power off/standby

Waste canister

Intravenous bag

Irrigation

Temperature Limitation: Indicates upper and lower temperature limits.

Humidity Limitations: Indicates upper and lower humidity limits.

Atmospheric Pressure Limitation: indicates upper and lower atmospheric pressure limits.

Manufacturer

Date of Manufacture

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Symbol

Description

Catalogue Number

SN

Serial Number

Please dispose of in accordance with local regulations for the collection or disposal of waste electrical and electronic equipment.

Recyclable material

Fragile, handle with care

Do not use if package is damaged

Contains Phthalates (DEHP)

Canadian Standards Association (CSA) Certification Mark

MR Unsafe

Chapter 1 • Patient and Operating Room Safety • 13