Integra CUSA NXT Ultrasonic Surgical Aspirator System

Transcription

1 Integra CUSA NXT Operator s Manual Integra CUSA NXT Ultrasonic Surgical Aspirator System OPERATOR S MANUAL Integra LifeSciences (Ireland) Limited IDA Business and Technology Park Sragh Tullamore, County Offaly, Ireland Integra CUSA NXT Operator s Manual Distributed By: Integra LifeSciences Corporation Plainsboro, NJ USA For more information or to place an order, please contact: Integra 311 Enterprise Drive, Plainsboro, NJ USA and Canada: (Outside USA) (Fax) integralife.com Integra, the Integra logo and CUSA are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries Integra lifesciences Corporation. All Rights Reserved , Issue 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: August 2013 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 is a trademark 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 Molnlycke Health Care Group. RECEPTAL is a registered trademark of Hospira, Inc Copyright Information: 2013 Integra LifeSciences Corporation. 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; County of Origin: Made in Ireland

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4 TABLE OF CONTENTS Chapter 1: Patient and Operating Room Safety System Overview... 1 Intended Use... 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 for Surgery... 6 Operating the CUSA NXT During Surgery... 8 Disassembly and Sterilization of CUSA NXT After Surgery... 8 Use of System in MRI Environments... 9 Troubleshooting the CUSA NXT System Technical Specifications Classification and System Symbols Tubing Pathway Symbols Footswitch Symbols Chapter 2: CUSA NXT System Setup and Components Unpacking and Installing the System Commissioning the System Initial Setup of Console with the Service Module List of CUSA NXT Components About the Console About the Footswitch About the Service Module About the Handpieces and Wrench Sets Handpieces Wrench Sets About the Tubing Kits About the Sterile and Non-Sterile Tips For Neuro Handpieces For Standard Handpieces Summary of Operating Safety Precautions Using the Handpieces i

5 Sterilizing Backup Handpieces Warnings and Hazards when Using the System Requirements for Servicing the System Explosion and Fire Hazards Latex Information Chapter 3: Using the Console, Service Module, and Handpieces About the Console Functionality About the Left Console Panel About the Rear Console Panel...35 Connecting Handpieces to the Console Using the Footswitch Pedals Using the Touch Screen Monitor Status/Alarm Symbols 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...50 List of MicroSurgical Handpieces Chapter 4: 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 Position the Footswitch Priming the Handpieces Testing the Alarm Tone Chapter 5: Operating the CUSA NXT During Surgery Operating the System During Surgery Warnings Relating to the Tips During Surgery ii

6 Customizing the User Settings Chapter 6: Disassembly and Sterilization of CUSA NXT After Surgery Dismantling the System After Surgery Cleaning the Handpieces After Surgery Disassembling the Handpieces Sterilizing and Maintaining the Handpieces Recommended Sterilization Procedures Disinfecting the Handpieces Maintaining the Handpieces Maintaining the Touch Screen Monitor Safety Guidelines Cleaning Guidelines Handling and Transporting the System Console with Service Module Console without Service Module Chapter 7: Use of System in MRI Environments About MRI Support Using Handpieces and Footswitch in Static Magnetic Fields List of Requirements List of MRI Safe Handpieces Neurosurgical Handpieces Chapter 8: 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 Appendix A: Technical Specifications Specifications for the CUSA NXT System Electrical Safety Standards and IEC Classifications Manufacturer s Declaration Table iii

7 Appendix B: Warranty Integra Warranty for the CUSA NXT Ultrasonic Surgical Aspirator Index iv

8 CHAPTER 1 PATIENT AND OPERATING ROOM SAFETY System Overview... 1 Intended Users... 2 Warnings, Cautions and Notices... 3 Classification and System Symbols 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. Chapter 1 Patient and Operating Room Safety 1

9 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. 2 Chapter 1 Patient and Operating Room Safety

10 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. Chapter 1 Patient and Operating Room Safety 3

11 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. 4 Chapter 1 Patient and Operating Room Safety

12 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

13 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 88. 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 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. 6 Chapter 1 Patient and Operating Room Safety

14 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 latex free. 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

15 Operating the CUSA NXT 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 After Surgery Warning To avoid injury to surgical personnel, keep fingers away from the pump rollers. 8 Chapter 1 Patient and Operating Room Safety

16 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 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. Chapter 1 Patient and Operating Room Safety 9

17 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 10 Chapter 1 Patient and Operating Room Safety

18 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 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

19 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 12 Chapter 1 Patient and Operating Room Safety

20 Symbol Description REF 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 Chapter 1 Patient and Operating Room Safety 13

21 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. 14 Chapter 1 Patient and Operating Room Safety

22 Footswitch Symbols The following symbols appear on the footswitch: Symbol Description Power pedal Fast Flush pedal Chapter 1 Patient and Operating Room Safety 15

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24 CHAPTER 2 CUSA NXT SYSTEM SETUP AND COMPONENTS Unpacking and Installing the System List of CUSA NXT Components About the Handpieces and Wrench Sets About the Tubing Kits About the Sterile and Non-Sterile Tips Summary of Operating Safety Precautions Unpacking and Installing the System When unpacking the system, inspect the shipment for any signs of damage or loss. If any items are damaged, notify the carrier, the supplier, and retain all shipping cartons for examination. Verify that the shipping carton(s) contain the following items: Console Carton: Console Power Cord NXT Operator s Guide Footswitch Service Module Carton (if applicable): Service Module Contamination Guard Caution If the packaging for a sterile accessory is damaged, do not use the sterile accessory. Notice In the event that you need to return a device to Integra, to prevent any damage, use the appropriate packaging material. Chapter 2 CUSA NXT System Setup and Components 17

25 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. 18 Chapter 2 CUSA NXT System Setup and Components

26 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 2 CUSA NXT System Setup and Components 19

27 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 Chapter 2 CUSA NXT System Setup and Components

28 Support for Service Module The Console supports the optional Service Module that provides suction and waste collection (see page 21). 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 36. Note that the Footswitch is internally sealed and may be cleaned by immersion (see page 74). The Footswitch is also supplied on its own as a spare part (Part # NXT10001). 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. About the Service Module The Service Module provides a convenient source of suction and a holding area for the aseptic waste collection canister. No further utilities are required. This module requires a 115 V or 230 V nominal grounded power supply. Chapter 2 CUSA NXT System Setup and Components 21

29 Warning TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAINS WITH PROTECTIVE EARTH. The Service Module includes a spare CUSA NXT contamination guard. For instructions on setting up the Service Module, see page 59. Collecting Waste A receptacle for collecting waste is required between the CUSA NXT Console and the vacuum source. RECEPTAL or Bemis Hi-Flow 2000 ml 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. 22 Chapter 2 CUSA NXT System Setup and Components

30 About the Handpieces and Wrench Sets Warning 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. Handpieces The CUSA NXT Console supports a range of handpieces: 35 khz Neurosurgery Handpiece For the list of CUSA Selector handpieces, see page 47. 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. Chapter 2 CUSA NXT System Setup and Components 23

31 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. Types of Wench Sets The following table provides the list of part numbers for the different wrench sets: Part # Description M1 For Standard handpieces M1, M2, M M2 For Laparoscopic handpiece M M3 For Neuro handpieces M5, M7, M8, M9, M5 (MRI), M5 (MRI), M7 (MRI), M8 (MRI) and M9 (MRI) For MicroSurgical handpieces M1, M M1 (MRI), and M2 (MRI). About the Tubing Kits The CUSA NXT System requires a supply of sterile tubing kits. Sterile tubing kits have a three year shelf life. Part # Description CUSA Selector Tubing Kit, disposable, single use, 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, disposable, single use, box of CUSA Selector MRI Tubing Kit Extension, disposable, single use, box of 10 For instructions on using the tubing kits, see page 60. For instructions on using the CUSA NXT System in an MRI suite, see Chapter Chapter 2 CUSA NXT System Setup and Components

32 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. Sterile tips sets have a five year shelf life. 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 Sterile Tip Set, 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) khz Neuro Long Sterile Tip Set (each 1) khz Neuro Sterile Tip Set (each 1) khz MicroSurgical Sterile Tip Set (each 1) *NXT khz Superior Forward Bone Tip Sterile Tip Set (box of 5) *NXT3218EA 24 khz Superior Forward Bone Tip Sterile Tip Set (each 1) *NXT khz Superior Reverse Bone Tip Sterile Tip Set (box of 5) *NXT3219EA 24 khz Superior Reverse Bone Tip Sterile Tip Set (each 1) *NXT khz Inferior Forward Bone Tip Sterile Tip Set (box of 5) *NXT3220EA 24 khz Inferior Forward Bone Tip Sterile Tip Set (each 1) * khz Extended Length Tip Sterile Tip Set (box of 5) * EA 35 khz Extended Length Tip Sterile Tip Set (each 1) *These sterile tips have a three year shelf life. Chapter 2 CUSA NXT System Setup and Components 25

33 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) khz Micro Tip Set (1 tip/5 flues) khz Neuro Tip Set (1 tip/5 flues) khz Neuro Short Tip Set (1 tip/5 flues) For Standard Handpieces See page 48 for information on non-sterile tips and flues. 26 Chapter 2 CUSA NXT System Setup and Components

34 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 you connect the handpiece to the Console, the handpiece becomes a functional surgical device. Warning 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, nonconductive, and highly visible surface. 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. Warning The handpiece and handpiece accessories must be sterile before surgical use. Chapter 2 CUSA NXT System Setup and Components 27

35 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 77). 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 IEC 60601). Warning Risk of explosion. Do not use in the presence of flammable anaesthetic gases or other volatile solvents. Warning 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. Warning For continued protection against fire and electrical hazard, replace fuse only with same type and rating. Caution 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. 28 Chapter 2 CUSA NXT System Setup and Components

36 Tightening the Handpieces with the Wrench Kits 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. Clearing Blocked Handpieces 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 from the tip end. Inspecting Handpiece Tips for Damage Warning 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. Caution 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. Priming the Handpieces Caution Do not use dry air sterilization methods involving temperatures in excess of 139 C (282 F); this may damage the handpiece. Caution 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. Chapter 2 CUSA NXT System Setup and Components 29

37 Notice To prevent fluid flowing into the vacuum line, only use a canister that has a non return valve. Components for Single Use Only The CUSA Selector tubing kit is supplied sterile for single use only. All flues are for single use only. Warning Use of the handpiece outside of the specified conditions can result in high operating temperatures. Warning Contact between the unprotected part of the tip and non-target tissue can result in burns. Warning Use of the handpieces in a damaged condition can result in an electric shock hazard. Warning Failure to maintain the CUSA NXT System in accordance with the instructions in this manual can compromise safety. Warning Use the single use CUSA Selector tubing, and single use tips and flue sets once only. Re-use may result in a biological hazard. Warning 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. 30 Chapter 2 CUSA NXT System Setup and Components

38 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 use in the presence of flammable anaesthetic gases 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. Chapter 2 CUSA NXT System Setup and Components 31

39 This page is intentionally left blank. 32 Chapter 2 CUSA NXT System Setup and Components

40 CHAPTER 3 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 38. A Footswitch containing two pedals for controlling the ultrasonic power and the rate of irrigation fluid. For instructions on using this Footswitch, see page 36. For information on the parts of the Console panels, see pages 34 to 35. Chapter 3 Using the Console, Service Module, and Handpieces 33

41 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. 34 Chapter 3 Using the Console, Service Module, and Handpieces

42 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. An appliance coupler can be used to isolate the system from the mains power source. Notice: To isolate the CUSA NXT from the AC power supply, you must unplug the Console from the power source. 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 Connection Port The port designated for the Footswitch plug. 5 Equipotential 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. This allows for the connection of a Potential Equalization Conductor that provides a connection between the equipment and the potential equalization busbar of the electrical installation (in accordance with the requirements of IEC ). This is a biomedical function. 6 Volume Control Knob Controls the volume of non-alarm tones emitted by the Console. Chapter 3 Using the Console, Service Module, and Handpieces 35

43 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. 35 khz Handpiece 24 khz MicroSurgical Handpiece Only connect one handpiece to the system at the same time. If you connect more than one handpiece at the same time, the system generates an alarm, and stops the ultrasonics. To connect the handpiece, align the red dot on the handpiece plug with the red dot on the handpiece connection point, and gently insert the plug until you hear a clicking sound. Warning When you connect the handpiece to the Console, the handpiece becomes a functional surgical device. 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 For instructions on assembling the handpiece, see page 56. Using the Footswitch Pedals The Footswitch contains two pedals: Power (left, orange) 36 Chapter 3 Using the Console, Service Module, and Handpieces

44 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. Align the red dot on the Footswitch plug with the red dot on the Footswitch connection point, and gently insert the plug until you hear a clicking sound. Note that the Footswitch is internally sealed and may be cleaned by immersion (see page 74). 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. Notice Do not press the ultrasonics Power pedal on the Footswitch during system startup or while connecting components to the Console. Chapter 3 Using the Console, Service Module, and Handpieces 37

45 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). 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 Chapter 3 Using the Console, Service Module, and Handpieces

46 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 41). 3 Information Panel Displays general information regarding the accumulated ultrasonic time and the current vacuum levels (see page 43). 4 Menu Buttons Displays menus for priming the handpieces, customizing user settings, and viewing online help (see page 44). For instructions on maintaining the touch screen, see page 80. Status/Alarm Symbols The CUSA NXT System activates an alarm to indicate a technical problem with the system. All alarms on the CUSA NXT are technical, low-priority alarms, for example, mechanical or equipment related. There are no physiological alarms on the CUSA NXT System. 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 Yellow) Alarm Classification Alarm Priority Aspiration Signifies an error in the aspiration process. Technical Low Power Signifies an error in the ultrasonic generator. Technical Low Footswitch Signifies a fault in the Footswitch or associated wiring. Technical Low Handpiece Signifies that a handpiece is not connected. Technical Low General Signifies an error in the electronics or power supplies. Technical Low Chapter 3 Using the Console, Service Module, and Handpieces 39

47 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 yellow. Warning 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. Notice 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 88. There is no method to silence alarms from the touch screen, therefore, to manually turn off an alarm, you must turn off the Console. If the system shuts down unexpectedly (for example, a power failure) with an alarm activated on the touch screen, the alarm remains activated when you power the system on again.the only method of turning off the alarm on the touch screen is to resolve the corresponding alarm. Recommended: When you set up the CUSA NXT System for surgery, make sure that the touch screen is always clearly visible to the surgeon in the event of an alarm, and the alarm tone is audible. Remove any obstructions that may block the surgeon s view of the touch screen. Alarm Tone This tone (on/off) sounds when an alarm activates. You cannot adjust the volume of the alarm tones. The alarm tone is less than 78dB. 40 Chapter 3 Using the Console, Service Module, and Handpieces

48 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%. The default power setting is 10%. The accuracy of the irrigation flow is +/- 20% of the setting. 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. Chapter 3 Using the Console, Service Module, and Handpieces 41

49 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. The default flow is 3 ml/min. The accuracy of the irrigation flow is +/- 20% of setting or +/-1 ml/min, whichever is greater. To adjust the 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 the system only delivers irrigant to the handpiece tip while pressing the Power Footswitch pedal. If pressing 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. 42 Chapter 3 Using the Console, Service Module, and Handpieces

50 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. The aspiration rate ranges from 15% to 100%. The default setting for aspiration is 100%. The accuracy of the aspiration rate is +/-50 mm Hg of available aspiration. 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%. Warning 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. 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. Chapter 3 Using the Console, Service Module, and Handpieces 43

51 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 63). Displays options for saving customized settings and specifying different languages (see page 70). Displays the online help system for accessing information on performing common tasks (see page 2). 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 Chapter 3 Using the Console, Service Module, and Handpieces

52 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. Unlocked, both front and rear casters roll easily and rotate freely. When locked, the front casters will not roll, and the rear casters will not roll or rotate. 4 Power Lead A short lead with a socket which fits the AC power inlet on the rear panel of the Console. An appliance coupler can be used to isolate the system from the mains power source. 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. Chapter 3 Using the Console, Service Module, and Handpieces 45

53 For instructions on using the Service Module (or other sources for suction and waste removal) during a surgical procedure, see page 59. 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. 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. 46 Chapter 3 Using the Console, Service Module, and Handpieces

54 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 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 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 77. List of Handpieces The following section provides the lists of Standard, Neurosurgical and MicroSurgical handpieces supported by the CUSA NXT System, and the tip, flue and shroud that correspond with each handpiece. Chapter 3 Using the Console, Service Module, and Handpieces 47

55 List of Standard Handpieces 24 khz Straight Handpiece (part # M1) Part # Description Picture -- Transducer assembly Standard tip, non-sterile, each Flue (disposable), non-sterile, single use, box of Straight shroud, each1 24 khz Angled Handpiece (part # M2) Part # Description Picture -- Transducer assembly Standard tip, non-sterile, each Flue (disposable), non-sterile, single use, box of Angled shroud, each Angled extension, each Extension shroud, each 1 48 Chapter 3 Using the Console, Service Module, and Handpieces

56 35 khz Straight Handpiece (part # M3) Part # Description Picture -- Transducer assembly Standard tip, non-sterile, each Flue (disposable), non-sterile, single use, box of Straight shroud, each 1 24 khz Laparoscopic Handpiece (part # M6) Part # Description Picture -- Transducer assembly Laparoscopic Tip, non-sterile, each Flue (disposable), non-sterile, single use, box of Step amplifier, each Laparoscopic Shroud, each Laparoscopic Shroud extension, each 1 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. It can beused 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 3 Using the Console, Service Module, and Handpieces 49

57 List of Neurosurgical Handpieces 24 khz Neurosurgical Short Handpiece (part # M7)Selector Part # Description Picture -- Transducer assembly Neuro Short Tip Set (includes Flue) non-sterile, box of khz Neuro Short Tip Set reusable (1 tip / 5 flues) Neuro Short Tip Set (single-use), sterile, box of Selector SaberTip (single-use), sterile, box of 5 NXT3218 NXT3218EA NXT3219 NXT3219EA Superior Forward Bone Cutting Tip, box of 5 Superior Forward Bone Cutting Tip, each 1 Superior Reverse Bone Cutting Tip, box of 5 Superior Reverse Bone Cutting Tip, each 1 NXT3220 NXT3220EA Inferior Forward Bone Cutting Tip, box of 5 Inferior Forward Bone Cutting Tip, each Angled shroud Angled extension Notice The flues are packed in either a sterile or non-sterile Tip Set. 50 Chapter 3 Using the Console, Service Module, and Handpieces

58 Notice The CUSA NXT Bone Tips can only be used with the CUSA NXT System. They cannot be used with the CUSA Selector System. The CUSA NXT Bone Tips can only be used with the 24 khz Neurosurgical handpiece (part # M7). The CUSA NXT Bone Tips cannot be used with the MRI version of this handpiece. 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. NXT Bone Tips for the 24 khz Neurosurgical handpiece (part # M7) The NXT Bone Tips are additional tips available only for the 24 khz Neurosurgical handpiece. Three types of NXT Bone Tips are available: The Superior Forward Bone Tip has an abrasive surface that is oriented superiorly at the distal end of the tip.this tip is principally designed to fragment, emulsify, and aspirate bone generally encountered in surgical approaches. The Superior Reverse Bone Tip has an abrasive surface that is oriented superiorly at the distal end of the tip.this tip is principally designed to fragment, emulsify and aspirate bone by withdrawing the surgical tip away from the target area towards the surgeon. The Inferior Forward Bone Tip has an abrasive surface that is oriented downward to the surgical tip bend. This tip is principally designed to fragment, emulsify, and aspirate bone generally encountered in surgical approaches. For specific information on using the NXT Bone Tips, see the Integra CUSA NXT Bone Tips Instructions for Use that comes with the NXT Bone Tips. Chapter 3 Using the Console, Service Module, and Handpieces 51

59 24 khz Neurosurgical Long Handpiece (part # M5) Part # Description Picture -- Transducer assembly Neuro Long Tip Set (single use) non-sterile, each Neuro Long Tip Set (single use) sterile, box of khz Neuro Long Sterile Tip Set (each 1) Angled shroud, each Clear extension flue, each Angled extension, each 1 Notice The flues are packed in either a sterile or non-sterile Tip Set. 35 khz Neurosurgical Handpiece (part # M9) Part # Description Picture -- Transducer assembly Neuro Tip Set (single use) non-sterile, 1 tip/5 flues Neuro Tip Set (single use) sterile, box of Neuro Tip Set (single use), sterile, box of Extended Length Tip (single use), sterile, box of EA Extended Length Tip (single use), sterile, each Angled shroud, each Angled extension, each 1 52 Chapter 3 Using the Console, Service Module, and Handpieces

60 Notice The flue and extension shroud are packaged in either a sterile or non-sterile Tip Set. Notice The Extended Length Tips are compatible with both the CUSA NXT and CUSA Selector Systems. The Extended Length Tip can only be used with the 35 khz NeuroSurgical Handpiece (part # M9). The Extended Length Tip cannot be used with the MRI version of this handpiece. Chapter 3 Using the Console, Service Module, and Handpieces 53

61 List of MicroSurgical Handpieces 24 khz MicroSurgical Handpiece (part # M2) Part # Description Picture -- Transducer assembly MicroSurgical Tip Set (single use), non-sterile MicroSurgical Tip Set (single use), sterile, box of MicroSurgical Tip Set (single use), sterile, each Microsurgical Tip Set, reusable, non sterile, 1 tip / 5 flues Angled shroud, each Angled extension, each 1 Notice The flues are packed in either a sterile or non-sterile Tip Set. 54 Chapter 3 Using the Console, Service Module, and Handpieces

62 CHAPTER 4 PREPARING THE CUSA NXT FOR SURGERY List of Requirements Assembling the Handpieces Preparing the System Priming the Handpieces Testing the Alarm Tone Notice If you will be operating in an MRI environment, see Chapter 7 for specific preparation instructions. List of Requirements Preparing the CUSA NXT System for surgery requires the following items: Console Footswitch Service Module or wall suction outlet One waste collection canister Sterile 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 The CUSA NXT System requires a minimum of one hour exposure at its operating temperature range before you use it. Make sure that the system is located in the surgical room at least an hour before use. Chapter 4 Preparing the CUSA NXT for Surgery 55

63 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. Caution 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. 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. 56 Chapter 4 Preparing the CUSA NXT for Surgery

64 3. Using the wrench, tighten the extension by turning it clockwise. 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. 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 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. Chapter 4 Preparing the CUSA NXT for Surgery 57

65 9. Attach the clear flue onto the shroud until firmly placed in position. See page 36 for information on connecting the handpiece to the Console. The handpiece is now ready for use. 58 Chapter 4 Preparing the CUSA NXT for Surgery

66 Preparing the System Preparing the system for surgery requires setting up the following items: Suction source IV Bag Tubing Kits Footswitch 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. Recommended: Position the Console so that the touch screen is clearly visible to the surgeon at all times and the alarm tone is audible. Remove any obstructions that may block the surgeon s view of the touch screen. Do not position the Console in a way that blocks access to the mains connector. If the Service Module is not being used, place the Console on a solid surface 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. Caution 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. 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. Notice 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. 4. Connect tubing from pinch valve (1) to patient waste port on canister. Chapter 4 Preparing the CUSA NXT for Surgery 59

67 5. Connect tubing from the contamination guard (2) to the vacuum port (3) on the canister 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 Primary Tubing Kit for Standard handpieces, have the assistant carefully peel back the outer covering of the Primary tubing kit (part# ) 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 sterile contents to the sterile operator. 60 Chapter 4 Preparing the CUSA NXT for Surgery

68 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. 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. Chapter 4 Preparing the CUSA NXT for Surgery 61

69 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 Warning To avoid injury to surgical personnel, keep fingers away from the pump rollers. 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 Route the aspiration tube through the pinch valve (1) and connect to the patient port on the suction canister. 62 Chapter 4 Preparing the CUSA NXT for Surgery

70 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. Position the Footswitch Connect the footswitch, see page 36. Position the footswitch where it is easily accessible to the surgeon. Priming the Handpieces Automatic priming is a 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. Chapter 4 Preparing the CUSA NXT for Surgery 63

71 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. 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) and may induce heat exchange with the patient or user, and cause tissue burns.. 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. 64 Chapter 4 Preparing the CUSA NXT for Surgery

72 Completing the Priming Process After priming the handpiece, the main screen will appear. For an overview of main screen, see page 38. Testing the Alarm Tone To verify the alarm tone functions correctly, you must intentionally trigger an alarm on the CUSA NXT System, for example, disconnect the footswitch from Console: 1. Disconnect the footswitch from the Console at the footswitch connector. 2. Verify that the footswitch alarm triggers on the system. 3. Verify that the system sounds the alarm tone. If the alarm tone doesn t sound, contact your Integra representative. The system is now ready for use (see Chapter 5). Chapter 4 Preparing the CUSA NXT for Surgery 65

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74 CHAPTER 5 OPERATING THE CUSA NXT DURING SURGERY Operating the System During Surgery Warnings Relating to the Tips During Surgery Customizing the User Settings Operating the System During Surgery After setting up the system, the system may be used for surgery. Warning The handpiece and handpiece accessories must be sterile before surgical use. Warning 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. Note the following guidelines when using the CUSA NXT during surgery: Chapter 5 Operating the CUSA NXT During Surgery 67

75 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 71). If there are no saved settings, use the touch screen to set the desired aspiration and irrigation levels. Note the following: Levels aspiration irrigation power Description Adjust the aspiration scale to the required level. 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. 68 Chapter 5 Operating the CUSA NXT During Surgery

76 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 8 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. 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. Warnings Relating to the Tips During Surgery Warning Touching of the tip of the handpiece by the operator, while the handpiece is powered on, can result in personal injury. Warning 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. Warning CUSA NXT tips utilize silicone flues. Compressing the flue against the side of the vibrating surface along the length of the tip can cause excessive heating and potential hazard to adjacent tissue, such as burns. Chapter 5 Operating the CUSA NXT During Surgery 69

77 Warning 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. Warning Avoid excessive lateral loading of CUSA NXT tips. This may result in equipment damage and/or injury to the patient or surgical personnel. Customizing the User Settings On the main screen, press the settings button to save ultrasonic settings and specify languages for on-screen 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. 70 Chapter 5 Operating the CUSA NXT During Surgery

78 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 On-screen Text Press the languages button to specify the language of the onscreen text (English, French, German, Italian, and Spanish). Chapter 5 Operating the CUSA NXT During Surgery 71

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80 CHAPTER 6 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 Handling and Transporting the System 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 70). 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. Warning To avoid injury to surgical personnel, keep fingers away from the pump valve Notice Do not remove the aspiration filter from the designated port prior to powering off the system. Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery 73

81 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). 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. Warning Electric Shock Hazard Always unplug the CUSA NXT System before cleaning it. Warning Do not allow fluids to enter the Console or Service Module. 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. 74 Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery

82 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. 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. Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery 75

83 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 (part # for the CUSA Selector Handpiece). 4. Place the wrench set in sterilization tray. 5. Place the disassembled handpiece and applicable accessories (reusable tip, reusable shroud, non-sterile flue, and angled extension) in a sterilization tray. 6. Sterilize according to hospital policy (see page 77). Notice 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. 76 Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery

84 Sterilizing and Maintaining the Handpieces Recommended Sterilization Procedures Before sterilization, clean the handpiece and accessories as described on page 75. 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 (reusable tip, reusable shroud, non-sterile flue and extender) into a sterilization tray. Double-wrap the sterilization tray in suitable sterilization grade paper and place fresh filters in the filter ports situated in the top and base of the sterilization tray. Filters must be replaced after each sterilization cycle. Integra LifeSciences also recommends using tamper resistant locks in conjunction with the filters for the unwrapped containers. Place these locks on the handle of the sterilization tray to ensure that the sterility has not been broken. Wrapping Conditions Minimum Temperature Cycle Dwell Time Minimum Dry Cycle Double wrapped with filters in the lid and base of container Double wrapped with the lid removed and filter in the base of container 134 C (273 F) Pre-vacuum cycle 3 minutes Pre-vacuum cycle 18 minutes 132 C (270 F) Pre-vacuum cycle 4 minutes 134 C (273 F) Pre-vacuum cycle 3 minutes Pre-vacuum cycle 18 minutes 132 C (270 F) Pre-vacuum cycle 4 minutes 10 Minutes 10 minutes Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery 77

85 Wrapping Conditions Minimum Temperature Cycle Dwell Time Minimum Dry Cycle Unwrapped with filters in the lid and base of container 134 C (273 F) Pre-vacuum cycle 3 minutes Pre-vacuum cycle 18 minutes 132 C (270 F) Pre-vacuum cycle 4 minutes 10 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. 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 have been conducted, however, it is solely the decision of the hospital to approve the use of these cycles. Disinfecting the Handpieces Disinfect the CUSA Selector handpiece in one of the following solutions: Glutaraldehyde based solutions such as Cidex or peracetic acid based solutions such as Nu-Cidex. Follow the instructions supplied by the manufacturer. Solutions of Hibicet or Hibitane 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 connector in the disinfecting solution. 78 Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery

86 Maintaining the Handpieces In addition to the post-operative care of the CUSA NXT System described on pages 73 and 75, further maintenance steps recommended by the manufacturer are as follows: General Maintenance At 6 Month Intervals 1. Remove and replace the contamination guard every six months, or when the filter changes color (part # NXT00005). Remove and replace 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. Contact Integra Service Center for information on replacing parts. 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. Contact Integra Service Center for information on returning equipment for service. Warning No modification of this equipment is allowed. Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery 79

87 Service Centers Service Centers United States International Address Integra NeuroSciences 5965 Pacific Center Blvd.Suite 714 San Diego, CA Tel: Fax: Integra NeuroSciences Halskestrasse 25 Ratingen Germany Tel: Fax: Maintaining the Touch Screen Monitor Use the following maintenance guidelines to ensure the touch screen functions optimally: Safety Guidelines Cleaning 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. 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. 80 Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery

88 Handling and Transporting the System If you need to move/relocate the CUSA NXT System within the environment of the Healthcare Facility, note the guidelines below. The CUSA NXT requires a minimum of one hour exposure at its operating temperature range before you use it; make sure that the system is located in the surgical room at least an hour before use. Console with Service Module Before moving the system: Unplug the power cord from the wall receptacle and place the power cord in the storage compartment at the rear of the Service Module. Disconnect the handpiece. Disconnect and remove the irrigation fluid. Retract the IV pole. Secure any loose objects. Make sure there are no loose objects placed on top of the Console. Disconnect the Footswitch and place the Footswitch in the storage compartment at the rear of the Service Module. When moving the system: Push the system using the handle; don t pull it. Do not run whilst pushing the system. Use a lift to move the system between floors of a building. Never use a stairwell. Do not attempt to lift the system. To move the system up or down a ramp, use two or more people. Console without Service Module Before moving the Console: Unplug the power cord from the wall receptacle. Disconnect the power cord from the Console. Disconnect the handpiece. Disconnect and remove the irrigation fluid. Retract the IV pole. Secure any loose objects. Make sure there are no loose objects placed on top of the Console. Disconnect the footswitch. When moving the Console (in the immediate environment): Lift the Console using the side grips. Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery 81

89 Place the Console on a solid surface. The surface must be flat, non-slip and free from obstruction. 82 Chapter 6 Disassembly and Sterilization of CUSA NXT After Surgery

90 CHAPTER 7 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 Footswitch 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 CUSA Selector MRI handpieces that are fitted with tips (one for the procedure and a second one for backup) Appropriate handpiece wrench set Chapter 7 Use of System in MRI Environments 83

91 List of MRI Safe Handpieces Notice For instructions on assembling the handpieces, see page 56. For more information on handpiece functionality, see page 47. Neurosurgical Handpieces 24 khz MicroSurgical Handpiece for MRI (part # M2) Part # Description Picture -- Transducer assembly MicroSurgical Tip Set (single use), non-sterile MicroSurgical Tip Set (single-use), sterile Angled shroud, each Angled extension, each 1 24 khz Neurosurgical Handpiece Long for MRI (part # M5) Part # Description Picture -- Transducer assembly Neuro Long Tip Set (single-use), sterile, box of Neuro Long Tip Set (single-use), sterile, each Neuro Long Angled shroud, each Extension Flue, non-sterile, box of Neuro Long angled extension, each 1 24 khz Neurosurgical Short Handpiece for MRI (part # M7) 84 Chapter 7 Use of System in MRI Environments