cusa nxttm Ultrasonic Tissue Ablation System OPERATOR S MANUAL

Transcription

1 cusa nxttm Ultrasonic Tissue Ablation System OPERATOR S MANUAL Distributed By: Integra LifeSciences Corporation Plainsboro, NJ USA Integra LifeSciences (Ireland) Limited IDA Business and Technology Park Sragh Tullamore, County Offaly, Ireland 2008 Integra LifeSciences. All Rights Reserved. Printed in Ireland NXT90001, Rev. C

2 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 Rev. C Effective Date December 2008 Trademark Acknowledgements CUSA NXT and the Integra wave logo are trademarks of Integra LifeSciences Corporation or its subsidiaries. CUSA and Selector are registered 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 registered trademark of Hospira, Inc. All trademarks are the property of their respective owners. Copyright Information 2008 Integra LifeSciences. All rights reserved. No 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 Distributed By: Integra LifeSciences Corporation. 311 Enterprise Drive Plainsboro, NJ USA Made in USA US and Canada (Outside USA) (Fax) UK/International Tel: +44 (0) Fax: +44 (0) (Fax)

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4 TABLE OF CONTENTS Chapter 1: About the CUSA NXT System System Overview...1 Indication for Use...1 Reviewing the Operator s Manual...1 Online Help...2 Unpacking and Installing the System...2 Commissioning the System...2 Initial Setup of Console with the Service Module...3 List of CUSA NXT Components...4 About the Console...4 About the Footswitch...5 About the Service Module...6 About the Handpieces and Wrench Sets...7 Handpieces...7 Wrench Sets...7 About the Tubing Kits...8 About the Sterile and Non-Sterile Tips...9 For Neuro Handpieces...9 For Standard Handpieces...9 Summary of Operating Safety Precautions...10 Using the Handpieces...10 Sterilizing Backup Handpieces...10 Warnings and Hazards when Using the System...10 Requirements for Servicing the System...12 Explosion and Fire Hazards...12 Latex Information...12 Chapter 2: Using the Console, Service Module, and Handpieces About the Console Functionality...13 About the Left Console Panel...14 About the Rear Console Panel...15 Connecting Handpieces to the Console...16 Using the Footswitch Pedals...16 Using the Touch Screen Monitor...18 Status/Alarm Symbols...19 i

5 Adjusting the Ultrasonic Control Scales Verifying General Ultrasonic Information Displaying Menus for Prime Mode, Customized Settings, and Online Help About the Service Module Functionality About the Handpiece Functionality List of Handpieces List of Standard Handpieces List of Neurosurgical Handpieces...28 List of Microsurgical Handpieces Chapter 3: Preparing the CUSA NXT for Surgery List of Requirements Assembling the Handpieces Preparing the System Prepare the Suction Source Prepare the IV Bag Prepare the Tubing Kits Connect Tubing to Console Priming the Handpieces Chapter 4: Operating the CUSA NXT During Surgery Operating the System During Surgery Customizing the User Settings Chapter 5: Disassembly and Sterilization of CUSA NXT After Surgery Dismantling the System After Surgery Cleaning the Handpieces After Surgery Disassembling the Handpieces...44 Sterilizing and Maintaining the Handpieces Recommended Sterilization Procedures Disinfecting the Handpieces Maintaining the Handpieces Maintaining the Touch Screen Monitor Safety Guidelines Cleaning Guidelines Chapter 6: Use of System in MRI Environments About MRI Support ii

6 Using Handpieces and Footswitch in Static Magnetic Fields...49 List of Requirements...49 List of MRI Safe Handpieces...50 Neurosurgical Handpieces...50 Chapter 7: Troubleshooting the CUSA NXT System About the Troubleshooting Process...53 Problems Powering the System On and Off...53 Responding to Alarms...54 Troubleshooting Aspiration Problems...55 Troubleshooting Irrigation Problems...56 Troubleshooting Ultrasonic Power Problems...57 Appendix A: Technical Specifications and Symbols Specifications for the CUSA NXT System...59 Electrical Safety...61 Standards and IEC Classifications...62 Classification Symbols...62 Tubing Pathway Symbols...63 Manufacturer s Declaration Table...64 Appendix B: Warranty Integra Warranty for the CUSA NXT Ultrasonic Surgical Aspirator...65 Index iii

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8 CHAPTER 1 ABOUT THE CUSA NXT SYSTEM System Overview... 1 Unpacking and Installing the System... 2 List of CUSA NXT Components... 4 About the Handpieces and Wrench Sets... 7 About the Tubing Kits... 8 About the Sterile and Non-Sterile Tips... 9 Summary of Operating Safety Precautions System Overview The CUSA NXT Ultrasonic Surgical Aspirator facilitates the removal of tissue. The system provides selective tissue disintegration with simultaneous irrigation and aspiration. Indication for 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. Reviewing the Operator s Manual Verify that all surgeons, nurses, and technicians who will be using, operating, and maintaining the CUSA NXT System review this Operator s Manual prior to using this system in a surgical procedure. Please pay close attention to the operating safety precautions on page 9. If there are additional questions after reading this manual, contact the technical support staff at Integra LifeSciences. Chapter 1 About the CUSA NXT System 1

9 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. For complete instructions on using the CUSA NXT System, refer to the procedures described in this Operator s Manual. Unpacking and Installing the System When unpacking the system, inspect the shipment for any signs of damage or loss. If any damages are discovered, notify the carrier, the supplier, and retain all shipping cartons for examination. Commissioning the System The manufacturer or supplier will normally commission the CUSA NXT System. For assistance on the installation procedures, contact the supplier. After commissioning the system, the supplier will provide training on preparing, operating, and maintaining the system. This will normally take place as an in-service training course to the appropriate doctors, nurses, and operating departments. 2 Chapter 1 About the CUSA NXT System

10 Initial Setup of Console with the Service Module 1. Place Console in the recess on top of the Service Module. 2. Plug the Service Module cord located in the module s top rear compartment into the power connector (1) on the rear of the Console Plug one end of the detachable power cord into the Service Module s power connector (2) on the rear of the module Connect the aspiration controller cable (3) located in the Service Module s top rear compartment to the port on the bottom of the Console (4) inside the compartment Tighten both connector screws. 6. Thread the locking thumbwheel located in the Service Module door into the threaded hole on the bottom of the Console inside the compartment. Tighten fully. Chapter 1 About the CUSA NXT System 3

11 List of CUSA NXT Components The CUSA NXT System consists of the Console, Footswitch, and Service Module (if applicable). Console Service Module About the Console The Console provides power to the selected ultrasonic handpieces. A touch screen monitor is used to control the aspiration, irrigation and ultrasonic power delivered to handpiece. This touch screen also provides access to the online help system. Note that the Console includes a detachable Power Cord. For instructions on using the Console, see page 13. Support for Service Module The Console supports the optional Service Module that provides suction and waste collection (see page 6). 4 Chapter 1 About the CUSA NXT System

12 About the Footswitch The Footswitch contains two pedals for controlling the power (left side, orange) and Fast Flush (right side, blue). Power pedal Fast Flush pedal The Footswitch also provides a 6m cord that connects to the Footswitch port located on the rear panel of the Console. For instructions on using the Footswitch pedals, see page 16. Note that the Footswitch is internally sealed and may be cleaned by immersion (see page 44). Chapter 1 About the CUSA NXT System 5

13 About the Service Module The Service Module provides a convenient source of suction and aseptic waste collection. No further utilities are required. This module requires a 115V or 230 V nominal grounded power supply. The Service Module includes a spare CUSA NXT contamination guard. For instructions on setting up the Service Module, see page 34. Collecting Waste A receptacle for collecting waste is required between the CUSA NXT Console and the vacuum source. RECEPTAL or Bemis Hi-Flow 2000 cc canisters are suggested. Using Other Suction Source Types If the CUSA NXT Console will not be used with the Service Module, then the Console will require another suitable source of suction and waste collection. Wall or ceiling mounted vacuum points in the operating room or a free-standing surgical suction unit should operate at a constant vacuum pressure between 560 mmhg and 620 mmhg with a free air flow capacity of more than 42 L/min. 6 Chapter 1 About the CUSA NXT System

14 About the Handpieces and Wrench Sets Handpieces The CUSA NXT Console supports a range of handpieces: 35 khz Neurosurgery Handpiece For the list of CUSA Selector handpieces, see page 26. Note that a brush for cleaning the aspiration channel of the handpiece is supplied with each handpiece (part # ). Wrench Sets Use the CUSA Selector wrench set when assembling and disassembling the handpiece for cleaning and sterilization. Each handpiece is supplied with an appropriate wrench set. Each wrench set consists of a stainless steel holder and wrench, connected by a chain. The cut-outs in the holder are sized according to its use with specific handpieces. Guidelines for Using the Wrench Sets Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. Chapter 1 About the CUSA NXT System 7

15 Types of Wench Sets The following table provides the list of part numbers for the different wrench sets: Part # M1 Description For handpieces M1, M2, M3, and M M2 For laparoscopic handpiece M M3 For handpieces M5, M7, M9, and M8 (MRI) and M9 (MRI) For MicroSurgical handpiece M2 and M2 (MRI). About the Tubing Kits The CUSA NXT System requires a supply of sterile tubing kits. Part # Description CUSA Selector Tubing Kit, box of 10 (primary tubing kit) In addition to the primary tubing kit, additional tubing kits are required when using the Microsurgical handpiece or using the system in an MRI environment: Part # Description CUSA Selector MicroSurgical Tubing Kit, box of CUSA Selector MRI Tubing Kit Extension, box of 10 For instructions on using the tubing kits, see page 35. For instructions on using the CUSA NXT System in an MRI suite, see Chapter 6. 8 Chapter 1 About the CUSA NXT System

16 About the Sterile and Non-Sterile Tips For Neuro Handpieces Sterile Tip Sets The CUSA Selector sterile tip sets include a sterilized tip and flue. The part numbers are as follows: Part # Description khz Neuro Long Sterile Tip Set (box of 5) khz Neuro Short Sterile Tip Set (box of 5) Selector SaberTip, for 24 khz Neuro Short only (box of 5) khz MicroSurgical Sterile Tip Set (box of 5) khz Neuro Sterile Tip Set (box of 5) Non-Sterile Tip Sets The CUSA Selector non-sterile tip sets include a non-sterile tip and flue. The part numbers are as follows: Part # Description khz Neuro Tip Set for Neuro Long and Neuro Short (box of 5) khz MicroSurgical Tip Set (box of 5) khz Neuro Tip Set (box of 5) For Standard Handpieces See page 26 for information on non-sterile tips and flues. Chapter 1 About the CUSA NXT System 9

17 Summary of Operating Safety Precautions 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. Please note that this operator s manual provides information only on operating the system. This manual does not provide instructions for any specific surgical procedure. It is imperative that the procedures described in this manual are followed carefully. Using the system in any other manner may result in personal injury. Using the Handpieces 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. Caution 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. Sterilizing Backup Handpieces The CUSA Selector handpiece may be sterilized by steam autoclave (see page 46). Integra LifeSciences recommends that a sterile backup handpiece be available for immediate use in the event of any contamination or malfunction during surgery. Make sure to sterilize the appropriate wrench set with the handpiece so the wrench set may be used to assemble the handpiece and tip. The wrench set should be kept sterile so that it may be used to replace the tip if necessary. Warnings and Hazards when Using the System Class 1 Type CF The CUSA NXT System is Class 1 type CF Patient connected electrically isolated equipment (reference EN 60601). Warning Risk of explosion. Do not use in the presence of flammable anaesthetic gases. For continued protection against fire hazard, replace fuse only with same type and rating. 10 Chapter 1 About the CUSA NXT System

18 Caution Electrical shock hazard. Do not remove cover. Refer servicing to authorized service personnel. Warning 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. Biomedical technicians should note that special attachments are required to connect the ultrasonic handpieces to test equipment used for electrical safety testing. Application of a vibrating handpiece to test equipment without these attachments may result in damage to both the test equipment and the handpiece. Tightening the Handpieces with the Wrench Kits 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. Clearing Blocked Handpieces 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. Inspecting Handpiece Tips for Damage 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. However 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. Priming the Handpieces Notice 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). Do not use dry air sterilization methods involving temperatures in excess of 139º C (282º F); this may damage the handpiece. Components for Single Use Only The CUSA Selector tubing kit is supplied sterile for single use only. All flues are for single use only. Chapter 1 About the CUSA NXT System 11

19 Hazards Associated with Improper Use Note the following hazards when using the CUSA NXT equipment improperly: 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. Requirements for Servicing the System Do not remove any instrument covers on the system or touch screen monitor. The CUSA NXT Console contains no user serviceable parts and the system must be serviced only by qualified Integra service engineers. Interference with the Console by any other personnel may invalidate the warranty and may result in injury. Explosion and Fire Hazards Warning Do not operate the CUSA NXT in the presence of flammable anaesthetic agents or other volatile solvents. Latex Information The components of the CUSA Selector handpieces that directly or indirectly come into contact with the patient are latex free. 12 Chapter 1 About the CUSA NXT System

20 CHAPTER 2 USING THE CONSOLE, SERVICE MODULE, AND HANDPIECES About the Console Functionality Using the Touch Screen Monitor Using the Footswitch Pedals About the Service Module Functionality About the Handpiece Functionality List of Handpieces About the Console Functionality The CUSA NXT Console contains the electronics, pumps, and mechanical parts for providing power to the selected handpiece used during ultrasonic surgery. To control the setpoint levels and for online help information, the Console uses: A touch screen monitor for specifying the aspiration, irrigation, and ultrasonic setpoint levels and for accessing online help. For instructions on using this monitor, see page 18. A Footswitch containing two pedals for controlling the ultrasonic power and the rate of irrigation fluid. For instructions on using this Footswitch, see page 16. For information on the parts of the Console panels, see pages 14 to 15. Chapter 2 Using the Console, Service Module, and Handpieces 13

21 About the Left Console Panel The following table describes the components and connection points on the left side of the Console Component Description 1 Irrigation Pump A peristaltic pump that pumps irrigant from the IV bag to the handpiece. This pump clamps into place across the irrigation tube of the disposable tubing set. Note that the direction of tubing connections to the pump are illustrated on the panel. 2 Aspiration Control Port The port designated for the aspiration filter of the tubing kit 3 Pinch Valve A normally open valve where the aspiration tube is routed before connecting to the suction system. When the Power Footswitch pedal is released, this valve closes momentarily and shuts off the suction and facilitates the release of tissue from the tip of the handpiece. When the Fast Flush Footswitch pedal is pressed, this valve closes and stops the aspiration. The valve re-opens when the Fast Flush Footswitch pedal is released. 4 Handpiece Connection Port Connection port for the 24 khz handpieces only. 5 IV Pole The pole that holds the bag of irrigation fluid. The pole will support a 500 ml or 1000 ml irrigation bag. If a larger bag is used, place the bag on a separate irrigation stand. To raise and lower the pole, adjust the locking nut at the bottom of the pole. 14 Chapter 2 Using the Console, Service Module, and Handpieces

22 About the Rear Console Panel The following table describes the components and connection points on the rear side of the Console: Component Description 1 AC Power Inlet An international standard inlet which accepts the power cord supplied with the Console or the power lead if used with the Service Module. 2 Power Button Turns the CUSA NXT Console on and off. Notice: When shutting down the system, the button has a blue light which remains on while the system goes through a shut down process. It does not immediately go out when pressed. 3 Cooling Fan Air Outlet Air, used to cool the internal electronic systems, leaves the Console through this grill, which should be kept clear of any obstruction. 4 Footswitch Port The port designated for the Footswitch plug. 5 Ground Point This external ground pin is connected to the main internal instrument grounding point and is used in some countries as the point for attaching a separate grounding lead. 6 Volume Control Knob Controls the volume of non-alarm tones emitted by the console. Chapter 2 Using the Console, Service Module, and Handpieces 15

23 Connecting Handpieces to the Console The Console contains 3 color-coded ports for connecting the different types of handpieces. Two of the ports appear on the front panel, while the third port appears on the left panel. Only one handpiece may be connected to the system at any time. 35 khz Handpiece 24 khz Microsurgical Handpiece Note the following color codes for each handpiece type: Color Panel Handpiece Type Red Left 24 khz Green Front 35 khz Black Front 24 khz Microsurgical Using the Footswitch Pedals The Footswitch contains two pedals: Power (left, orange) Fast Flush (right, blue). Power pedal Fast Flush pedal To connect the Footswitch to the Console, attach the Footswitch cord to the appropriate port on the rear of the Console panel. Note that the Footswitch is internally sealed and may be cleaned by immersion (see page 44). 16 Chapter 2 Using the Console, Service Module, and Handpieces

24 Pressing the Power Pedal Pressing this pedal will: Switch on the irrigation at the preset rate indicated on the front panel irrigation display. Switch on the ultrasonic power to a level which varies in an approximately linear fashion from zero (when the pedal is not pressed), to the maximum value indicated on the front panel power display (when the pedal is fully pressed). Notice After releasing the Power pedal, the pinch valve operates momentarily to block aspiration and facilitate tissue release from the handpiece tip. Activating the Handpiece To activate the handpiece, press the Power pedal for at least 2 seconds. 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. Pressing the Fast Flush Pedal Pressing this pedal will: Switch on irrigation at a rate of 50 ml/min. Note that the irrigation setting on the front panel display has no influence upon the irrigation rate when the Fast Flush pedal is pressed independently. Stop aspiration (until the pedal is released). Chapter 2 Using the Console, Service Module, and Handpieces 17

25 Using the Touch Screen Monitor The CUSA NXT Console provides a touch screen monitor for viewing and controlling the power, irrigation, and aspiration levels during an ultrasonic case This touch screen provides the following tools: Tools Description 1 Status / Alarm Symbols Displays colored symbols to indicate the status of the major ultrasonic components. For specific information, see the page Ultrasonic Control Scales Controls the power, irrigation, and aspiration settings during an ultrasonic case (see page 20). 3 Information Panel Displays general information regarding the accumulated ultrasonic time and the current vacuum levels (see page 22). 4 Menu Buttons Displays menus for priming the handpieces, customizing user settings, and viewing online help (see page 22). For instructions on maintaining the touch screen, see page Chapter 2 Using the Console, Service Module, and Handpieces

26 Status/Alarm Symbols The five symbols that appear on top of the touch screen provide status information on the major ultrasonic components. Symbol Normal Status Alarm Indicator (When Flashing Yellow) Aspiration Signifies an error in the aspiration process. Power Signifies an error in the ultrasonic generator. Footswitch Signifies a fault in the Footswitch or associated wiring. Handpiece Signifies that a handpiece is not connected. General Signifies an error in the electronics or power supplies. During normal operation, all the symbols appear green. If an error occurs with any of the major components, an alarm will sound and the respective symbol will turn from green to flashing yellow. Notice If you press the flashing yellow symbol, the touch screen monitor will display error and problem resolution information. For more information on responding to alarms, see page 54. Chapter 2 Using the Console, Service Module, and Handpieces 19

27 Adjusting the Ultrasonic Control Scales Use the power, irrigation, and aspiration scales to control the major ultrasonic settings during a case. Adjusting the Power Level Use the power scale (orange) to specify the ultrasonic power output (tip amplitude). The power settings range between 10% and 100%. Note that raising the power setting will increase the vibration of the handpiece tip and thus increase tissue fragmentation rate. To adjust the power by 5% increments, use the arrows to the right of the scale. To adjust the power by 10% increments, press the segment bars on the scale. Notice 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. 20 Chapter 2 Using the Console, Service Module, and Handpieces

28 Adjusting the Irrigation Level Use the irrigation scale (blue) to specify the rate of irrigation that will be delivered to the handpiece. The irrigation rate ranges between 2 and 20 ml/minute. To adjust this rate by 1 ml/minute increments, use the arrows to the right of the scale. To adjust the rate by 2 ml/minute increments, press the desired segment on the scale. Notice Note that irrigant will only be delivered to the handpiece tip while pressing the Power Footswitch pedal. If pressing the Fast Flush Footswitch pedal, this setting on the irrigation scale is ignored and an irrigation rate of about 50 ml/min is applied to the handpiece. Adjusting the Aspiration Level Use the aspiration scale (green) to specify the aspiration rate of the total available suction of the source of vacuum employed. To adjust the rate by 5% increments, press the arrows to the right of the scale. To adjust the rate by 10% increments, press the segment bars on the scale. Note that typical aspiration rates are between 30% and 100%. Notice The minimum aspiration level setting is 15%. This ensures proper handpiece cooling and performance. Insufficient aspiration can cause premature handpiece or tip failures. Chapter 2 Using the Console, Service Module, and Handpieces 21

29 Verifying General Ultrasonic Information Use the information panel to determine the general status of the current operating modes and equipment selection. This panel provides the following information: Symbol Description Displays the total accumulated ultrasonic time since the machine was powered on. This value will reset to 00:00 if the machine is turned off for more than 30 minutes. Displays the current vacuum level from the aspiration source. This level is measured in mm hg units. Displaying Menus for Prime Mode, Customized Settings, and Online Help Use the menu buttons to access features for priming the handpiece, customizing user settings, and displaying online help. Note the following buttons: Button prime settings help Description Displays the prime panel for priming the handpiece for surgery (see page 37). Displays options for saving customized settings and specifying different languages (see page 41). Displays the online help system for accessing information on performing common tasks (see page 2). 22 Chapter 2 Using the Console, Service Module, and Handpieces

30 About the Service Module Functionality The Service Module provides a convenient, mobile base for the CUSA NXT Console, as well as a source of suction and waste collection. It is controlled from the Console and has no user accessible controls. Front Rear The Service Module contains the following components: Component Description 1 Suction Port In the top center of the front section of the Service Module, there is a protective filter and an attachment point for the suction tubing which leads internally to the vacuum pump. The protective filter (part # NXT00005) should be replaced every six months or earlier if contaminated. Note that this filter is different from the type used in the disposable tubing kit. 2 Container Receptacle The space at the front of the Service Module for accommodating a variety of commercially available waste containers. For instructions on the tubing connections for the canister, see page Castors The Service Module provides four antistatic rotating castors. The rear castors feature brakes which are set and released by pressing the pedal on the castor. Chapter 2 Using the Console, Service Module, and Handpieces 23

31 Component Description 4 Power Lead A short lead with a socket which fits the AC power inlet on the rear panel of the Console. 5 Communication Cable A short cable that provides communication from the Console to the Service Module. The cable plugs into the bottom of the console when it is placed on the Service Module. 6 Storage Area for Footswitch and Power Cord The enclosure behind the rear door of the Service Module that accommodates the Footswitch and power cord of the Console when the system is not in use. 7 AC Power Inlet An international standard inlet which accepts the power cord supplied with the Console. 8 Power Switch Turns the power to the Service Module on and off. This switch must be turned on to power on the CUSA NXT Console. For instructions on using the Service Module (or other sources for suction and waste removal) during a surgical procedure, see page 34. Rear View of Console Attached to Service Module Console Service Module Caution Do not store anything in the storage area in the back of the Console while the system is running. 24 Chapter 2 Using the Console, Service Module, and Handpieces

32 Notice 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. About the Handpiece Functionality Each CUSA Selector handpiece contains the following components Components Description 1 Tip The titanium alloy tip is unique to each handpiece, having a designated thread to minimize the possibility of attaching it to the wrong handpiece. 2 Shroud Black heat resistant shrouds that are interconnected by snap-in push fittings with the exception of the laparoscopic handpiece which has a screw thread joint. The shrouds cover one or two titanium alloy parts: All handpieces contain a tip. Angled handpieces also include an angled extension. These titanium alloy parts are fitted with screw threads and are removable for cleaning and sterilizing using the appropriate handpiece wrench set. 3 Handle Contains the piezoelectric transducer which includes an array of piezo ceramic elements to convert the high frequency power signal from the CUSA NXT Console into mechanical vibration at 24 khz or 35 khz depending on the handpiece type. 4 Piezoelectric Transducer (Internal) Generates negligible heat and requires no external cooling system. Each handpiece conforms to the highest levels of electrical safety. All the handpieces are Type CF (Cardiac Floating) with a patient leakage current of less than 10 μ A. Note that the rear section of the handpiece does not contain any user-serviceable parts. Under no circumstance should it be tampered with. 5 Flue The tip of the handpiece is covered by a one-piece or two-piece clear flue to protect tissues around the tip and ensure clarity of view during operation. For instructions on maintaining the handpieces, see page 46. Chapter 2 Using the Console, Service Module, and Handpieces 25

33 List of Handpieces The following section provides the lists of standard, neurosurgical, and microsurgical handpieces supported by the CUSA NXT System: List of Standard Handpieces 24 khz Straight (part # M1) Part # Description Picture -- Transducer assembly Standard tip, non-sterile Flue (disposable), non-sterile Straight shroud 24 khz Angled (part # M2) Part # Description Picture -- Transducer assembly Standard tip, non-sterile Flue (disposable), non-sterile Angled shroud Angled extension Extension shroud 26 Chapter 2 Using the Console, Service Module, and Handpieces

34 35 khz Straight (part # M3) Part # Description Picture -- Transducer assembly Standard tip, non-sterile Flue (disposable), non-sterile Straight shroud 24 khz Laparoscopic (part # M6) Part # Description Picture -- Transducer assembly Laparoscopic Tip, non-sterile Flue (disposable), non-sterile Step amplifier Shroud Shroud extension About the Laparoscopic Handpieces The Laparoscopic handpiece is a variant of the standard straight 24 khz CUSA Selector handpiece in which the front of the handpiece is extended to facilitate its use in laparoscopic surgery. This handpiece has an external diameter along its working length of 10 mm and has been used with both reusable and disposable 10/10.5 mm trocar introducers. The Laparoscopic handpiece has been designed for the dissection and selective removal of unwanted tissue in gastrointestinal surgery. It is not intended for use in liposuction procedures. When used in a gentle but continuously moving action, it is capable of removing cellular tissue and fat while sparing fibrous structures such as nerves, blood vessels and membranes. Note that the Laparoscopic handpiece is fitted with a clamp at the rear end through which the aspiration/irrigation tube should be passed. Chapter 2 Using the Console, Service Module, and Handpieces 27

35 List of Neurosurgical Handpieces 24 khz Neurosurgical Short (part # M7) Part # Description Picture -- Transducer assembly Neuro Short Tip Set (single-use), non-sterile Neuro Short Tip Set (single-use), sterile Selector SaberTip (single-use), sterile Angled shroud Angled extension Notice The flues are packed in either a sterile or non-sterile Tip Set. Selector SaberTip for 24 khz Neurosurgical Short (part # ) The Selector SaberTip is an additional tip available only for the 24 khz Neurosurgical Short handpiece. This tip is designed specifically to selectively remove hard tissue such as bone. It has an abrasive surface that is oriented superiorly at the distal end of the tip. For specific information on using this device, see the Selector SaberTip Instructions for Use that comes with the Selector SaberTip. 28 Chapter 2 Using the Console, Service Module, and Handpieces

36 24 khz Neurosurgical Long (part # M5) Part # Description Picture -- Transducer assembly Neuro Long Tip Set (single use) non-sterile Neuro Long Tip Set (single use) sterile Angled shroud Clear extension flue Angled extension Notice The flues are packed in either a sterile or non-sterile Tip Set. 35 khz Neurosurgical (part # M9) Part # Description Picture -- Transducer assembly Neuro Tip Set (single use) non-sterile Neuro Tip Set (single use) sterile Angled shroud Angled extension Notice The flue and extension shroud are packaged in either a sterile or non-sterile Tip Set. Chapter 2 Using the Console, Service Module, and Handpieces 29

37 List of Microsurgical Handpieces 24 khz MicroSurgical (part # M2) Part # Description Picture -- Transducer assembly MicroSurgical Tip Set (single use), non-sterile MicroSurgical Tip Set (single use), sterile Angled shroud Angled extension Notice The flues are packed in either a sterile or non-sterile Tip Set. 30 Chapter 2 Using the Console, Service Module, and Handpieces

38 CHAPTER 3 PREPARING THE CUSA NXT FOR SURGERY List of Requirements Assembling the Handpieces Preparing the System Priming the Handpieces Notice If you will be operating in an MRI environment, see Chapter 6 for specific preparation instructions. List of Requirements Preparing the CUSA NXT System for surgery requires the following items: Console Service Module or wall suction outlet One waste collection canister Tubing Kit Sterile intravenous fluid in container (500 ml isotonic saline is recommended) Two sterile handpieces that are fitted with tips (one for the procedure and a second one for backup) Appropriate handpiece wrench set Chapter 3 Preparing the CUSA NXT for Surgery 31

39 Assembling the Handpieces Assemble the CUSA Selector handpiece in the sterile field: 1. Using the appropriate wrench set, secure Flat 2 (2) of the handpiece into the designated slot of the holder Using your fingers, screw the silver angled extension into the handle. Notice If you are using either a straight or laparoscopic handpiece, the angled extension is not required. 3. Using the wrench, tighten the extension by turning it clockwise Caution With correct use of the wrench, it is not possible to overtighten the joint. However, if the joint is not firmly tightened, the handpiece will not function correctly and may be noisy and overheat during use. Warning Using the incorrect wrench set to assemble/disassemble the handpiece may damage the handpiece. 4. Reposition the handpiece into the holder, securing Flat 1 (1) of the angled extension into the designated slot of the holder Chapter 3 Preparing the CUSA NXT for Surgery

40 5. Using your fingers, screw the tip into the angled extension. 6. Using the wrench, tighten the tip by turning it clockwise. 7. Remove the handpiece from the holder. 8. Attach the black shroud onto the handpiece by centering and aligning the shroud with the silver angled extension. Warning Failure to center the shroud may cause the handpiece to overheat. 9. Attach the clear flue onto the shroud until firmly placed in position. The handpiece is now ready for use. Chapter 3 Preparing the CUSA NXT for Surgery 33

41 Preparing the System Preparing the system for surgery requires setting up the following items: Suction source IV Bag Tubing Kits Prepare the Suction Source 1. Depending on the type of suction source being used, do one of the following: If the Service Module is being used with the Console, position it in a convenient location outside the sterile field. If the Service Module is not being used, place the Console on a trolley outside the sterile field. Note that the external suction source must operate at a minimum vacuum pressure between 560 mmhg and 620 mmhg with a free air flow capacity more than 42 L/min. 2. If applicable, place a canister liner in the suction canister and connect the tubes in the suction canister. 3. Ensure that a contamination guard is fitted to protect the vacuum pump in the Service Module. Warning Tubing kits must never be connected directly to the vacuum source as contamination will occur. 4. Connect tubing from pinch valve (1) to patient waste port on canister. 5. Connect tubing from the contamination guard (2) to the vacuum port (3) on the canister Chapter 3 Preparing the CUSA NXT for Surgery

42 Prepare the IV Bag 1. Lift the IV pole on the rear of the Console to an elevated position and turn the knurled locking ring clockwise to secure the extended section. Place the sterile intravenous fluid container onto the hook at the end of the pole. 2. Place the sterile handpiece and accessories in the sterile field and unwrap. Prepare the Tubing Kits 1. Open the appropriate tubing kit onto the sterile field and select the desired handpiece(s). 2. Inspect all tubing before use. Note the following: For the Microsurgical handpiece, have the assistant carefully peel back the outer covering of the Microsurgical tubing kit (# ) and offer the sterile contents to the sterile operator. For all MRI handpieces, have the assistant carefully peel back the outer covering of the MRI tubing extension (part # ) and offer the contents to the sterile operator. 3. Retain the yellow stylet and white hose clips in the sterile field. Notice All of the handpiece and tubing kit components in the CUSA NXT System are latex free. 4. Connect the tubing to the handpieces. Attach the double lumen tube from the standard tubing kit to the irrigation (1) and aspiration (2) ports on the back of the handpiece. 1 2 Back End of Handpiece If you are using the Microsurgical or MRI handpieces: For the Microsurgical handpiece, attach the micro tubing kit to the irrigation (1) and aspiration (2) ports on the back of the handpiece. Connect the other end of the tubing to the standard tubing kit. Chapter 3 Preparing the CUSA NXT for Surgery 35

43 For all MRI handpieces, connect the standard tubing to the MRI tubing extension and then attach the sterile double lumen tubing directly to the rear end of the handpiece. Note that the larger lumen fits on the large central aspiration port while the smaller lumen fits onto the smaller irrigation port. 5. Using the white hose clips supplied with the tubing kit, secure the tubing and handpiece cord. 6. Depending on the console location, reserve the desired amount of tubing to be used in the sterile field. 7. Hand the remaining tubing to the console location in the non-sterile area. Connect Tubing to Console Follow the diagram on the side label of the Console: Notice 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. 1. Route the smaller irrigation tubing through the peristaltic pump (1) and secure latch Chapter 3 Preparing the CUSA NXT for Surgery

44 2. Route the aspiration tube through the pinch valve (1) and connect to the patient port on the suction canister. 3. On the left side of the console, connect the aspiration filter to the designated port (2). 2 1 Notice Do not remove the aspiration filter from the designated port prior to powering off the system. Priming the Handpieces Automatic priming is a new feature on the CUSA NXT System. Manual methods for priming used with previous versions of Selector may still be performed, however, you must at least start and then stop the initial prime cycle in order to proceed with system operation. If any alarm conditions exist upon initial startup (e.g. handpiece or footswitch not connected), the prime screen will not appear until these alarms are resolved. 1. Turn on the system by pressing the main power button located on the rear panel of the Console and on the Service Module (if utilized); the prime screen will appear automatically. Chapter 3 Preparing the CUSA NXT for Surgery 37

45 2. On the prime screen, press the start button; the CUSA NXT will start to prime the handpiece and display a progress bar. To stop the priming process at any time, press the stop button. Caution 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). 3. During the priming process, verify that fluid completely fills the line to the handpiece and irrigant flows from the tip of the handpiece. If irrigant does not flow from the tip, press the prime button and re-start the priming process until fluid starts to flow from tip. To stop the priming process at any time, press the stop button. Completing the Priming Process After priming the handpiece, the main screen will appear. For an overview of main screen, see page 18. The system is now ready for use (see Chapter 4). 38 Chapter 3 Preparing the CUSA NXT for Surgery

46 CHAPTER 4 OPERATING THE CUSA NXT DURING SURGERY Operating the System During Surgery Customizing the User Settings Operating the System During Surgery After setting up the system, the system may be used for surgery. Note the following guidelines when using the CUSA NXT during surgery: Increasing the power setting (orange) increases cell disruption at the handpiece tip. Increasing the irrigation setting (blue) increases the irrigation flow. Increasing the aspiration setting (green) increases the suction at the handpiece tip. During the surgical procedures, you may adjust these variables by adjusting the appropriate scales on the touch screen. 1. Verify that the handpiece is fully primed. 2. Set the aspiration, irrigation, and power levels to the desired settings. If desired, use the presets option to select the pre-defined settings (see page 42). If there are no saved settings, use the touch screen to set the desired aspiration and irrigation levels. Note the following: Levels aspiration Description Adjust the aspiration scale to the required level. Chapter 4 Operating the CUSA NXT During Surgery 39

47 Levels irrigation power Description Adjust the irrigation scale to the required level. Note that irrigation levels between 2 and 8 ml/min are typically used. Adjust the power scale to the required value. Note that power settings between 40% and 100% are typically used. 3. Hold the handpiece in the sterile field and verify the following: The tip is not in contact with any object. The aspiration and irrigation tubes are free from kinks or other obstructions. 4. Press the Power pedal on the Footswitch for at least 2 seconds to activate the handpiece. Verify that a fine aerosol spray of irrigant appears at the tip showing that ultrasonic power is present. Notice In Step 4, 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. The system is now ready for surgical use. 5. To operate the ultrasonic aspirator, press the Power pedal. Aspiration operates continuously and irrigation is activated at the pre-set level when the pedal is pressed. Ultrasonic power is controlled in a linear fashion - increasing as the Power pedal is pressed further until, at full depression, it reaches the maximum level set on the power display on the front panel. 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. 6. If the surgeon only wishes to irrigate the operating site, press the Fast Flush Footswitch pedal. Irrigant will flow from the end of the handpiece at a rate of 50 ml/min. 7. If a problem occurs, see Chapter 7 for troubleshooting guidelines. 8. If blockage occurs in the handpiece during operation, use the supplied sterilized nylon stylet to clear it. When using the stylet, pass it into the titanium tip of the handpiece until the blockage is cleared. After clearing the blockage, wash the tip as described in the following section, "Cleaning the Handpiece During Surgery". Caution 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. 40 Chapter 4 Operating the CUSA NXT During Surgery

48 9. If for any reason the Console is powered down for a period of less than 30 minutes and then powered up, the Surgery Mode is immediately accessed, bypassing the normal priming procedure. Cleaning the Handpiece During Surgery During intervals of operative use, Integra LifeSciences recommends immersing the tip of the handpiece momentarily into sterile water or saline. This will prevent blood and tissue debris from drying on the inner surfaces of the handpiece and aspiration line and minimize the risk of a blockage in the aspiration system. Customizing the User Settings On the main screen, press the settings button to save ultrasonic settings and specify languages for onscreen text. Note the following settings: Settings presets Description Provides functions for saving and restoring power, irrigation, and aspiration values. language Provides options for displaying the touch screen content into 5 different languages: English, French, Italian, German, and Spanish. Note the presets settings can be customized depending on surgeon s needs, while the languages settings are customized prior to shipping. Chapter 4 Operating the CUSA NXT During Surgery 41

49 Saving Customized Ultrasonic Settings Press the presets button to save customized settings or restore the default settings. To save customized settings for subsequent sessions: 1. Adjust the power, irrigation, and aspiration settings to the desired levels. 2. On the main screen, press the settings button and choose the presets option. 3. On the displayed panel, press the save current set points button. The system will save the current power, irrigation, and aspiration levels. The next time the system is turned on, the CUSA NXT System will restore these values. To restore the default settings, press presets on the settings panel and choose restore default set points option. The CUSA NXT System will restore the factory settings for the power, irrigation, and aspiration levels. Specifying Languages for Onscreen Text Press the languages button to specify the language of the onscreen text (English, French, German, Italian, and Spanish). 42 Chapter 4 Operating the CUSA NXT During Surgery

50 CHAPTER 5 DISASSEMBLY AND STERILIZATION OF CUSA NXT AFTER SURGERY Dismantling the System After Surgery Cleaning the Handpieces After Surgery Sterilizing and Maintaining the Handpieces Maintaining the Touch Screen Monitor Dismantling the System After Surgery After an operative procedure, dismantle the system and prepare it for storage. 1. If the same settings used during the operation may be required for future use, use the preset feature to save them (see page 41). 2. Remove the handpiece from the operating area and flush it by aspirating at least 100 ml of isotonic fluid. Note that the residue from the intravenous fluid container usually provides a convenient source of fluid. 3. Remove the hose clips from the handpiece cable. 4. Disconnect the tubing set from the handpiece. 5. Disconnect the contamination guard tubing from the vacuum port of the canister. 6. Remove the intravenous fluid container from the tubing set and discard. 7. Remove the irrigation tube from the peristaltic pump, the aspiration tube from the pinch valve and the aspiration filter from the Console. If using a disposable liner, remove it from the suction canister and discard together with the entire tubing set. If using a hard canister, discard it with entire tubing kit. Notice Do not remove the aspiration filter from the designated port prior to powering off the system. Notice Do not re-use the tubing kit as this compromises sterility and may lead to damage of the Console and/or Service Module. Notice Do not remove the contamination guard situated in the receptacle bay at the front of the Service Module. 8. Turn off the power on the rear panel of the CUSA NXT Console and Service Module (if utilized). Remove the main power cord from the Console or Service Module as appropriate, wipe clean and store in the rear cupboard of the Service Module (if utilized). Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery 43

51 9. Disconnect the Footswitch and wipe clean. If the Footswitch is contaminated with blood or fluid, it may be cleaned by immersing it in warm water containing detergent or disinfectant (the port must be kept dry) and rinsed. Allow the Footswitch to drain after washing and store in the rear storage area of the Service Module (if utilized). 10.Wipe the Console and the Service Module with a clean cloth dampened with warm water and a mild detergent, disinfectant or alcohol when necessary to remove blood or dirt. Lower the irrigation pole by turning the knurled locking ring counter-clockwise. 11. Remove the handpiece cable from the Console and disconnect from the handpiece. Wipe the cable with a clean cloth dampened with warm water and a mild detergent, disinfectant or alcohol when necessary to remove blood or dirt. Notice 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. Cleaning the Handpieces After Surgery Disassembling the Handpieces Prior to sterilization, disassemble and clean the CUSA Selector handpiece: 1. In a sink or bowl, prepare a cleaning solution containing warm water with detergent. This is necessary for cleaning the handpiece parts. Consult hospital policy for approved cleaning materials. 2. Remove and dispose of the clear flue in compliance with the hospital policy for disposal of contaminated waste. 3. Remove the black shroud and place in the cleaning solution. 4. Lay the handpiece in the appropriate wrench holder with the wrench flat secured in the holder cut-out. 44 Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery

52 5. Using the appropriately sized end of the wrench, loosen the tip by turning it counterclockwise. Unscrew the tip and place it in the cleaning solution. If the tip is single-use only or shows evidence of damage, discard the tip. 6. Reposition the handle of the handpiece in the holder cut out and using the same wrench set as before, loosen the angled extension by turning it counterclockwise. Notice If you are using either a straight or laparoscopic handpiece, the angled extension is not required. 7. Detach the angled extension and place it in cleaning solution. 8. Keeping the plug dry, place the handpiece handle and cord into cleaning solution. Guidelines for Cleaning the Handpieces 1. Clean all handpiece parts thoroughly using an aspiration port brush (part # ) to clean the inner channels, pushing it in the direction of aspiration (i.e. from tip to handle). 2. Rinse all parts in clean water (keeping the plug dry) and dry thoroughly. 3. Clean and rinse the wrench set and add it to the sterilization tray. 4. Place the wrench set in sterilization tray. 5. Place the disassembled handpiece and accessories (tip, shroud, flue, and angled extension) in a sterilization tray, adding a new tip and new flue when necessary. 6. Sterilize according to hospital policy (see page 46). Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery 45

53 Sterilizing and Maintaining the Handpieces Recommended Sterilization Procedures Before sterilization, clean the handpiece and accessories as described on page 44. Note that sterilization systems in use at hospitals are chamber specific. As a result, Integra LifeSciences can only recommend a reference for hospitals to aid the sterilization parameters set for your hospital system. Integra LifeSciences has validated the following sterilization cycles for your consideration. Steam Sterilization Place the disassembled handpiece and applicable accessories (tip, shroud, flue and extender) into a sterilization tray. Double-wrap the sterilization tray in suitable sterilization grade paper, or place fresh filters in the filter ports situated in the top and base of the sterilization tray. When using filters, verify that they are replaced after each sterilization cycle. Integra LifeSciences also recommends using tamper resistant locks in conjunction with the filters. Place these locks on the handle of the sterilization tray to ensure that the sterility has not been broken. Wrapping Temperature Cycle Dwell Time Dry Cycle Wrapped 121 C (250 F) Pre-vacuum 16 minutes 20 to 30 minutes Wrapped 134 C (273 F) Pre-vacuum 5 minutes 20 to 30 minutes Wrapped 134 C (273 F) Pre-vacuum 3 minutes 10 minutes Unwrapped 134 C (273 F) Pre-vacuum (FLASH) 3 minutes 5 minutes Cooling Handpieces Before Use Allow the handpiece to cool completely before use. Note that it is the user s responsibility to verify that the handpiece and components are completely dry prior to setup. Validations for Steam Sterilization Integra LifeSciences has validated steam sterilization. The challenge organism used was > 1 x 10 6 Bacillus stereothermophilus. Bacillus stearothermophilus. Biological indicators were placed in the areas identified as the most difficult to sterilize, representing worst case conditions. The biological indicators were inoculated into Tryptone Soya Broth and incubated for seven days. The biological indicators produced no growth, indicating that a Sterility Assurance Level (SAL) of 10-6 was achieved. Caution Validation of the steam cycles described above have been conducted, however, it is solely the decision of the hospital to approve the use of these cycles. 46 Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery

54 Disinfecting the Handpieces Disinfect the CUSA Selector handpiece in one of the following solutions: Glutaraldehyde based solutions such as Cidex 1 or peracetic acid based solutions such as Nu-Cidex 2. Follow the instructions supplied by the manufacturer. Solutions of Hibicet 2 or Hibitane 2 in water or ethanol. Follow the instructions supplied by the manufacturer. Warning Disinfecting solutions containing sodium hypochlorite may cause damage to the metal tip of the handpiece and are not recommended. Do not immerse the handpiece cable plug in the disinfecting solution. Maintaining the Handpieces In addition to the post-operative care of the CUSA NXT System described on pages 43 and 44, further maintenance steps recommended by the manufacturer are as follows: General Maintenance At 6 Month Intervals 1. Remove and replace the contamination guard (part # NXT00005) and silicone hose that connects the suction port on the Service Module to the waste canisters. 2. Examine all shroud sections and replace if damaged. 3. Examine all cable and electrical connectors for signs of excessive wear and damage, and replace if damaged. Preventive Maintenance At 12 Month Intervals Integra service personnel should undertake preventative maintenance. In addition to complete cleaning, performance and safety checks on the Console, Service Module, Footswitch and handpieces should be carried out. Full details of these checks are available from the manufacturer or supplier. 1. Cidex and Nu-Cidex are trademarks of Johnson & Johnson. 2. Hibicet and Hibitane are trademarks of Regent Medical limited. Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery 47

55 Service Centers Service Centers United States International Address Integra NeuroSciences 5965 Pacific Center Blvd.Suite 714 San Diego, CA Tel: Fax: Integra NeuroSciences GmbHHalskestrasse 25 Ratingen Germany Tel: Fax: Maintaining the Touch Screen Monitor Use the following maintenance guidelines to ensure the touch screen functions optimally: Safety Guidelines To reduce the risk of shock, follow all safety notices and never open the touch screen monitor case. Turn off the system before cleaning. The slots located on the sides and top of the touch screen are for ventilation. Do not block or insert anything inside the ventilation slots. Keep the touch screen dry at all times. Do not pour liquid into or onto the touch screen. If the touch screen becomes wet, contact technical support. Do not attempt to repair it yourself. Cleaning Guidelines To clean the touch screen, use window/glass cleaner, eyeglass cleaner, or a quaternary ammonia disinfectant. Put the cleaner on the rag and wipe the touch screen. Never apply cleaner directly to the touch screen. Do not use alcohol (methyl, ethyl, or isopropyl) or any strong solvent. Do not use thinner or benzene, abrasive cleaners, or compressed air. Do not wipe the touch screen with either a cloth or sponge that could scratch the surface. Cleaning the Display Cabinet Use a cloth that is lightly dampened with a mild detergent. 48 Chapter 5 Disassembly and Sterilization of CUSA NXT After Surgery

56 CHAPTER 6 USE OF SYSTEM IN MRI ENVIRONMENTS About MRI Support List of Requirements List of MRI Safe Handpieces About MRI Support This chapter describes the procedures for using the CUSA NXT in an interoperative MRI environment. Using Handpieces and Footswitch in Static Magnetic Fields Warning When using the CUSA NXT System in an interoperative MRI suite, you must place the system Console and Service Module outside the 5 gauss line for proper operation and safety. The CUSA Selector MRI handpieces and the standard CUSA NXT Footswitch may be used in static magnetic fields up to 0.5 Tesla. The Console and Service Module are not MRI safe. List of Requirements Preparing the CUSA NXT System for surgery in an interoperative MRI suite requires the following items: Console Service Module or wall suction outlet One waste collection canister Tubing kit MRI tubing kit Sterile intravenous fluid in container (500 ml isotonic saline is recommended) Two sterile CUSA Selector MRI handpieces that are fitted with tips (one for the procedure and a second one for backup) Appropriate MRI handpiece wrench set Chapter 6 Use of System in MRI Environments 49

57 List of MRI Safe Handpieces Notice For instructions on assembling the handpieces, see page 32. For more information on handpiece functionality, see page 25. Neurosurgical Handpieces 24 khz Neurosurgical Short MRI (part # M7) Part # Description Picture -- Transducer assembly Neuro Short Tip Set (single-use), non-sterile Neuro Short Tips Set (single-use), sterile Selector SaberTip (single-use) sterile Angled shroud Angled extension 35 khz Neurosurgical MRI (part # M9) Part # Description Picture -- Transducer assembly Neuro Tip Set (single use), non-sterile Neuro Tip Set (single-use), sterile Angled shroud Angled extension 50 Chapter 6 Use of System in MRI Environments

58 24 khz MicroSurgical MRI (part # M2) Part # Description Picture -- Transducer assembly MicroSurgical Tip Set (single use), non-sterile MicroSurgical Tip Set (single-use), sterile Angled shroud Angled extension Chapter 6 Use of System in MRI Environments 51

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60 CHAPTER 7 TROUBLESHOOTING THE CUSA NXT SYSTEM About the Troubleshooting Process Problems Powering the System On and Off Responding to Alarms Troubleshooting Aspiration Problems Troubleshooting Irrigation Problems Troubleshooting Ultrasonic Power Problems About the Troubleshooting Process If you encounter problems when using the CUSA NXT System, first verify that the system is set up correctly. For complete setup instructions, see Chapter 3 in this manual. About this Chapter The following sections provide guidelines for troubleshooting and resolving specific problems. If the problems persist, contact technical support for service. Problems Powering the System On and Off If the system does not start properly, try rebooting the system: 1. On the back of the Console, press and hold the power button for 6 seconds. 2. Unplug the unit from the wall and then plug it back in. 3. Power up the unit normally. Chapter 7 Troubleshooting the CUSA NXT System 53

61 Responding to Alarms Symbol Alarm Causes Recommendations Aspiration Tubing not attached to suction canister. Attach the tubing to the suction canister. Power Improper tip assembly. Tighten the tip. Reconnect the handpiece. Handpiece Bad tip. Handpiece not connected. Two or more handpieces are connected. Replace the tip. Reconnect the handpiece. Connect the handpiece to the appropriate port: Red 24 khz Green 35 khz Black 24 khz Microsurgical Disconnect extra handpieces. Footswitch Footswitch not connected. Connect the Footswitch to the rear of Console. More than one Footswitch pedal is pressed. Release one Footswitch pedal. Footswitch pedal is pressed while connecting components to the Console. Release the Footswitch pedal. General System General system fault. Restart the system. If the alarm persists, contact technical support. Notice If you press the flashing yellow symbol, the touch screen monitor will display error and problem resolution information. 54 Chapter 7 Troubleshooting the CUSA NXT System

62 Troubleshooting Aspiration Problems Problem Causes Recommendations Insufficient Aspiration Service Module is unplugged. Plug in the Service Module. Excessive Aspiration Tubing is routed incorrectly. Tubing is not connected to the suction source. Aspiration level displayed on the touch screen is too low. Tubing is blocked or occluded. Pinch valve not working correctly. Suction canister is full. Suction canister is cracked. Contamination filter is clogged. Aspiration tubing is pinched or kinked. Hole in the aspiration tubing. Liquid permeates the Footswitch. Tubing between handpiece and Console is blocked or occluded. Handpiece is blocked. Aspiration is set too high. Aspiration pinch valve stays open. Aspiration set point level cannot be reduced. See the diagram on the Console for correct routing. Ensure that the filter is fully inserted. Connect the tubing to the suction source. See page 34. Set aspiration level to appropriate level. Unblock tubing with the stylet or saline flush. Contact technical support. Remove the suction canister and replace with a new one. Remove the suction canister and replace with a new one. Check the contamination filter on both the tubing and the Service Module for clogs. If a clog exists, replace the appropriate filter. Remove the pinch or kink from the tubing. Inspect the aspiration tubing for holes. If holes are found, replace the tubing. Replace the Footswitch with a new one. Unblock the tubing with the stylet or saline flush. Unblock the handpiece with the stylet. Reduce the aspiration level setting. Contact technical support. Contact technical support. Chapter 7 Troubleshooting the CUSA NXT System 55

63 Troubleshooting Irrigation Problems Problem Causes Recommendations Excessive Irrigation Incorrect rate set. Set the appropriate rate (normally between 2 and 6 ml/min). Tubing is not routed correctly. Irrigation pump is not fully closed. Broken Fast Flush pedal on the Footswitch. Irrigation pump is running at an excessive speed. Liquid permeates the Footswitch. See the diagram on the Console for the correct routing. Close the irrigation pump. Replace the Footswitch with a new one. Contact technical support. Replace the Footswitch with a new one. Insufficient Irrigation Incorrect rate set. Set the appropriate rate (normally between 2 and 6 ml/min). Footswitch is unplugged. IV spike is not inserted into the bag. IV bag is empty. Tubing is not connected to the irrigation pump correctly. Plug in the Footswitch. Insert the spike into the IV bag. Replace the IV bag with a new one. Reconnect the tubing. See page 36. Tubing is not primed. Prime the tubing. See page 37. Irrigation tubing is blocked. Irrigation tubing is pinched or kinked. Hole in the irrigation tubing. Broken Fast Flush pedal on Footswitch. Pump does not rotate when pressing the Footswitch. Liquid permeates the Footswitch. Inspect the tubing for blockage. Remove the pinch or kink from the tubing. Inspect the irrigation tubing for holes. If holes are found, replace the tubing. Replace the Footswitch with a new one. Contact technical support. Replace the Footswitch with a new one. 56 Chapter 7 Troubleshooting the CUSA NXT System

64 Troubleshooting Ultrasonic Power Problems Problem Causes Recommendations Insufficient Power Footswitch is unplugged. Plug in the Footswitch. Power level is not set appropriately. Improper tip assembly. The Footswitch power pedal is broken; the pedal will not turn on. Set the power level appropriately (normally set between 70% and 100%). Detach the tip and reassemble the handpiece; or Detach the tip and replace it with a new one. Replace the Footswitch with a new one. Excessive Power Liquid permeates the Footswitch. The Footswitch power pedal is broken; the pedal will not turn off. Liquid permeates the Footswitch. Replace the Footswitch with a new one. Replace the Footswitch with a new one. Replace the Footswitch with a new one. Handpiece Failure Handpiece is overheating. Insufficient aspiration. See page 55 for troubleshooting tips. No power to handpiece. Try the following: Verify that the handpiece is plugged into the correct port. Replace the handpiece with a new one. If the problems persists, contact technical support. Tip Failure Tip overheating. Insufficient irrigation. See page 56 for troubleshooting tips. No Power to System System is not turned on. Turn on the system. Service Module is not plugged in. Plug in the Service Module to the Console. Chapter 7 Troubleshooting the CUSA NXT System 57

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66 APPENDIX A TECHNICAL SPECIFICATIONS AND SYMBOLS Specifications for the CUSA NXT System Electrical Safety Standards and IEC Classifications Classification Symbols Tubing Pathway Symbols Manufacturer s Declaration Table Specifications for the CUSA NXT System Console Specifications Parameter Height Width Depth Weight Aspiration Irrigation Specification 31.8 cm (12.5 in) 45.7 cm (18 in) 58.9 cm (23.2 in) 20.9 kg (46 lbs) 15 to 100% of available vacuum 2 to 20 ml/min (accuracy +/- 20% of reading) Service Module Specifications Parameter Height Width Depth Weight Specification 86.1 cm (33.9 in) 50.3 cm (19.8 in) 76.6 cm (28.6 in) 45.4 kg (100 lbs) Appendix A Technical Specifications and Symbols 59

67 Parameter Vacuum Vacuum Capacity Specification 635 mmhg 75 L/min free air minimum Footswitch Specifications Parameter Height Width Depth Weight Length Specification 6 cm (2.4 in) 19.5 cm (7.7 in) 22 cm (8.7 in) 2 kg (4.4 lbs) 5.81 m (19 ft) Input Power Source Specifications Parameter Power Requirements Power Consumption Specification 115V~, 50/60 Hz and 230V~, 50 Hz 200 VA Console 700 VA Console with Service Module Environmental Conditions Parameter Specification Operating Temperature Range 10º to 35ºC Storage Temperature Range - 20º to 60ºC Operating Humidity Range Storage Humidity Range Operating Atmospheric Pressure Range 30% to 75% RH 25% to 85% RH 700 to 1100 kpa 60 Appendix A Technical Specifications and Symbols

68 Low Frequency Leakage Parameter Leakage Enclosure Leakage Current < 300 A Storage Temperature Range < 100 A μ μ Power Cord Specifications AC Power Supply Power Cord Part # Destination volts USA/Canada volts / UK/Europe Replace fuses with only those of the same type and rating. For details, see labeling on the rear panel. Electrical Safety The CUSA NXT System requires a single grounded electrical outlet providing power at 115V~, 50/60 Hz and 230V~, and 50 Hz (for set voltage, see the rear panel above the AC power inlet). The maximum current drawn is 2.5 amps at 240 volts and 5 amps at 100 volts. The removable power cord supplied with the system provides the power. Correct grounding of the CUSA NXT Console is essential for safe operation. The Console is grounded via the power cord; verify that this cord is connected to a properly grounded power receptacle of appropriate rating. Only use the power cord supplied with the system since these cords vary according to destination. An external ground point is also located on the rear panel (see page 15). Appendix A Technical Specifications and Symbols 61

69 Standards and IEC Classifications Quality Systems The CUSA NXT is manufactured by Integra LifeSciences. Integra LifeSciences operates a quality system that complies with ISO 13485, CMDCAS. International Bodies The CUSA NXT has been designed, constructed, and approved to the requirements of the following international bodies: International Electrotechnical Commission (IEC) Underwriters Laboratories (UL) Safety Standards The CUSA NXT has been independently tested and complies with the following standards: CSA 22.2 No EN UL EN Note that the Footswitch is additionally rated IPX8 for moisture resistance. Classification Symbols The following symbols appear on the labeling: Symbol Description Attention, see instructions for use. Refer to instructions for use. The equipment meets type CF (Cardiac Floating) safety standards. Equipotential point 62 Appendix A Technical Specifications and Symbols

70 Symbol Description Waste canister Intravenous bag Irrigation Tubing Pathway Symbols The following symbols define the tubing pathways: Symbol Description IV bag; direction of irrigation tubing towards to peristaltic pump. Irrigation; above peristaltic pump. Handpiece; direction of tubing assembly to aspiration filter port and pinch valve. Handpiece; direction of tubing assembly to aspiration filter port. Aspiration; direction of tubing assembly to pinch valve. Appendix A Technical Specifications and Symbols 63