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78

• Chapter 6 • Disassembly and Sterilization of CUSA

®

NXT After Surgery

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.

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.

Unwrapped with
filters in the lid and
base of container

134 °C (273 °F)

Pre-vacuum cycle 3
minutes

10 minutes

Pre-vacuum cycle 18
minutes

132 °C (270 °F)

Pre-vacuum cycle 4
minutes

Unwrapped with
filters in the lid and
base of container

134 °C (273 °F)

Pre-vacuum cycle 18
minutes

20-30
minutes

Wrapping
Conditions

Minimum
Temperature

Cycle Dwell Time

Minimum
Dry Cycle

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.

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.

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Содержание CUSA NXT

Страница 1: ...r more information or to place an order please contact Integra n 311 Enterprise Drive Plainsboro NJ 08536 USA and Canada 800 997 4868 n 609 936 5400 Outside USA 888 980 7742 Fax integralife com Integr...

Страница 2: ...n Hibicet and Hibitane are trademarks of Regent Medical Limited RECEPTAL is a trademark of Hospira Inc Copyright Information 2018 Integra LifeSciences Corporation All Rights Reserved No part of this d...

Страница 3: ...This page is intentionally left blank...

Страница 4: ...nments 9 Troubleshooting the CUSA NXT System 10 Technical Specifications 10 Classification and System Symbols 10 Tubing Pathway Symbols 14 Footswitch Symbols 16 Chapter 2 CUSA NXT System Setup and Com...

Страница 5: ...erifying General Ultrasonic Information 43 Displaying Menus for Prime Mode Customized Settings and Online Help 44 About the Service Module Functionality 44 About the Handpiece Functionality 47 List of...

Страница 6: ...Guidelines 80 Handling and Transporting the System 81 Console with Service Module 81 Console without Service Module 81 Shipping Instructions 82 Chapter 7 Troubleshooting the CUSA NXT System About the...

Страница 7: ...iv This page is intentionally left blank...

Страница 8: ...urgery 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 hand...

Страница 9: ...To draw immediate attention to matters of importance this guide presents warnings cautions and notices as follows Online Help On the touch screen monitor press the help button to display the online he...

Страница 10: ...the Healthcare Facility to ensure that intended users of CUSA NXT System are appropriately trained in the use of this equipment Warning Only operate the footswitch when the base of the footswitch is...

Страница 11: ...t 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 p...

Страница 12: ...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...

Страница 13: ...he 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 inste...

Страница 14: ...bing 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 sign...

Страница 15: ...missions 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...

Страница 16: ...e 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 a...

Страница 17: ...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...

Страница 18: ...st 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...

Страница 19: ...avenous bag Irrigation Temperature Limitation Indicates upper and lower temperature limits Humidity Limitations Indicates upper and lower humidity limits Atmospheric Pressure Limitation indicates uppe...

Страница 20: ...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 Pht...

Страница 21: ...s define the tubing pathways Non Sterile Caution consult accompanying documents Not manufactured with dry or natural rubber latex Keep Dry Do not re use Symbol Description Symbol Description IV bag di...

Страница 22: ...oom Safety 15 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...

Страница 23: ...16 Chapter 1 Patient and Operating Room Safety Footswitch Symbols The following symbols appear on the footswitch Symbol Description Power pedal Fast Flush pedal...

Страница 24: ...m 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 contai...

Страница 25: ...n 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 sy...

Страница 26: ...Console 3 Plug one end of the detachable power cord into the Service Module s power connector 2 on the rear of the module 4 Connect the aspiration controller cable 3 located in the Service Module s to...

Страница 27: ...onsole 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 scree...

Страница 28: ...itch 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 About the Ser...

Страница 29: ...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 o...

Страница 30: ...e use according to the instructions in Chapter 6 Wrench Sets Use the CUSA Selector wrench set when assembling and disassembling the handpiece for cleaning and sterilization Each handpiece is supplied...

Страница 31: ...e different wrench sets About the Tubing Kits The CUSA NXT System requires a supply of sterile tubing kits Sterile tubing kits have a three year shelf life For instructions on using the tubing kits se...

Страница 32: ...s Each pack contains one tip and one flue 1523235 35 kHz Neuro Sterile Tip Set 5 packs Each pack contains one tip and one flue 1523211 24 kHz Neuro Short Sterile Tip Set 1 tip and 1 flue 1523221 24 kH...

Страница 33: ...acks Each pack contains one tip and one flue 1529066 24 kHz MicroSurgical Tip Set 5 packs Each pack contains one tip and one flue 1523078 35 kHz Neuro Tip Set 5 packs Each pack contains one tip and on...

Страница 34: ...rgical 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 Wh...

Страница 35: ...d 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 Warning Risk of explosion Do not use in the...

Страница 36: ...the stylet from the tip end 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...

Страница 37: ...s 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...

Страница 38: ...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 Latex Information The component...

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

Страница 40: ...nics 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 scr...

Страница 41: ...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 t...

Страница 42: ...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 Cons...

Страница 43: ...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 Note the...

Страница 44: ...wer 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 approximatel...

Страница 45: ...pon 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 monit...

Страница 46: ...mponents For specific information see the page 39 2 Ultrasonic Control Scales Controls the power irrigation and aspiration settings during an ultrasonic case see page 41 3 Information Panel Displays g...

Страница 47: ...ouch 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 a...

Страница 48: ...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...

Страница 49: ...w 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...

Страница 50: ...are between 30 and 100 Verifying General Ultrasonic Information Use the information panel to determine the general status of the current operating modes and equipment selection This panel provides th...

Страница 51: ...ce 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 Button De...

Страница 52: ...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...

Страница 53: ...ew of Console Attached to 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 I...

Страница 54: ...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...

Страница 55: ...ure Transducer assembly 1523013 Standard tip non sterile each 1 1523042 Flue disposable non sterile single use box of 20 1523017 Straight shroud each1 Part Description Picture Transducer assembly 1523...

Страница 56: ...rointestinal surgery 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...

Страница 57: ...5 Ultrafine MicroTip Set single use sterile 5 packs where each pack contains 1 tip and 1 flue 1523216 Selector SaberTip single use sterile box of 5 NXT3218 Superior Forward Bone Cutting Tip box of 5 N...

Страница 58: ...orly 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 sur...

Страница 59: ...ingle use non sterile 5 packs where each pack contains 1 tip and 1 flue 1523225 Neuro Long Tip Set single use sterile 5 packs where each pack contains 1 tip and 1 flue 1523221 24 kHz Neuro Long Steril...

Страница 60: ...Tip Set single use sterile 1 tip and 1 flue 1523243 Extended Length Tip single use sterile box of 5 1523243 EA Extended Length Tip single use sterile each 1 1523060 Angled shroud each 1 1523058 Angle...

Страница 61: ...non sterile 5 packs where each pack contains 1 tip and 1 flue 1529165 MicroSurgical Tip Set single use sterile 5 packs where each pack contains 1 tip and 1 flue 1529161 MicroSurgical Tip Set single u...

Страница 62: ...ropriate 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...

Страница 63: ...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 th...

Страница 64: ...the holder 5 Using your fingers screw the tip into the angled extension 6 Using the wrench tighten the tip by turning it clockwise 7 Remove the handpiece from the holder 8 Attach the black shroud ont...

Страница 65: ...Preparing the CUSA NXT for Surgery 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 r...

Страница 66: ...g 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...

Страница 67: ...ce 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 N...

Страница 68: ...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 5 Using the white hose clips supplied with the tubing kit se...

Страница 69: ...tch 2 Route the aspiration tube through the pinch valve 1 and connect to the patient port on the suction canister Warning To avoid injury to surgical personnel keep fingers away from the pump rollers...

Страница 70: ...ng 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 i...

Страница 71: ...hat 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 unt...

Страница 72: ...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 con...

Страница 73: ...66 Chapter 4 Preparing the CUSA NXT for Surgery This page is intentionally left blank...

Страница 74: ...the system the system may be used for surgery Note the following guidelines when using the CUSA NXT during surgery Warning The handpiece and handpiece accessories must be sterile before surgical use...

Страница 75: ...hat a fine aerosol spray of irrigant appears at the tip showing that ultrasonic power is present The system is now ready for surgical use 5 To operate the ultrasonic aspirator press the Power pedal As...

Страница 76: ...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 hand...

Страница 77: ...e 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 appropr...

Страница 78: ...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 rest...

Страница 79: ...72 Chapter 5 Operating the CUSA NXT During Surgery This page is intentionally left blank...

Страница 80: ...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 D...

Страница 81: ...ockwise 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 ne...

Страница 82: ...nsult hospital policy for approved cleaning materials 2 Remove and dispose of the clear flue after use in compliance with the hospital policy for disposal of contaminated waste 3 Remove the black shro...

Страница 83: ...the plug dry and dry thoroughly 3 Clean and rinse the wrench set and add it to the sterilization tray part 07289 for the CUSA Selector Handpiece 4 Place the wrench set in sterilization tray 5 Place th...

Страница 84: ...ce 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 sterilizati...

Страница 85: ...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 Solutio...

Страница 86: ...te 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 Ce...

Страница 87: ...eaning Guidelines To clean the touch screen use window glass cleaner eyeglass cleaner or a quaternary ammonia disinfectant Put the cleaner on the rag and wipe the touch screen Never apply cleaner dire...

Страница 88: ...oose 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 movi...

Страница 89: ...out cardboard box adding sufficient soft packaging to cushion and protect the contents Consoles Modules and Footswitches It is recommended that flight cases be used on all occasions for air transporta...

Страница 90: ...when using the CUSA NXT System first verify that the system is set up correctly For complete setup instructions see Chapter 4 in this manual About this Chapter The following sections provide guidelin...

Страница 91: ...ed Connect the handpiece to the appropriate port Red 24 kHz Green 35 kHz Black 24 kHz Microsurgical Two or more handpieces are connected Disconnect extra handpieces Footswitch Footswitch not connected...

Страница 92: ...eplace with a new one Suction canister is cracked Remove the suction canister and replace with a new one Contamination filter is clogged Check the contamination filter on both the tubing and the Servi...

Страница 93: ...the appropriate rate normally between 2 and 6 ml min Footswitch is unplugged Plug in the Footswitch IV spike is not inserted into the bag Insert the spike into the IV bag IV bag is empty Replace the...

Страница 94: ...place the Footswitch with a new one Excessive Power The Footswitch power pedal is broken the pedal will not turn off Replace the Footswitch with a new one Liquid permeates the Footswitch Replace the F...

Страница 95: ...88 Chapter 7 Troubleshooting the CUSA NXT System This page is intentionally left blank...

Страница 96: ...NXT System Console Specifications Service Module Specifications Parameter Specification Height 31 8 cm 12 5 in Width 45 7 cm 18 in Depth 58 9 cm 23 2 in Weight 20 9 kg 46 lbs Aspiration 15 to 100 of...

Страница 97: ...n Power Requirements 115 230 V 50 60 Hz Console 115 230 V 50 60 Hz 50 Hz Service Module Power Consumption 250 VA Console 700 VA Console with Service Module Parameter Specification Operating Temperatur...

Страница 98: ...onditions 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 Parameter Leakage Touch Current 100 A Patient...

Страница 99: ...The removable power cord supplied with the system provides the power Correct grounding of the CUSA NXT Console is essential for safe operation The Console is grounded via the power cord verify that t...

Страница 100: ...ing standards CAN CSA C22 2 NO 60601 1 08 Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance IEC 60601 1 2005 Medical Electrical Equipment General Requ...

Страница 101: ...ment RF emissions CISPR 11 Class A The CUSA NXT System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that su...

Страница 102: ...onment If the user of the CUSA NXT System requires continued operation during power mains interruptions it is recommended that the CUSA NXT System be powered from an uninterruptible power supply or a...

Страница 103: ...obile RF communications equipment should be used no closer to any part of the CUSA NXT System including cables than the recommended separation distance calculated from the equation applicable to the f...

Страница 104: ...ions equipment and the CUSA NXT System The CUSA NXT System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the CUSA N...

Страница 105: ...98 Appendix A Technical Specifications This page is intentionally left blank...

Страница 106: ...signed by Customer iii defects emanating from Customer s improper or negligent installation storage or use of the Equipment or any component thereof including but not limited to operating the Equipmen...

Страница 107: ...retion of Integra as the case may be and where not possible Integra shall arrange and pay to ship the affected Equipment to the designated repair facility and shall repair the affected Equipment 3 1 2...

Страница 108: ...CIAL OR OTHER DAMAGES WHETHER ARISING IN CONTRACT OR IN TORT BY VIRTUE OF THE WARRANTY OR ANY PERFORMANCE OR BREACH BY INTEGRA ITS AFFILIATES ASSIGNEES OR SERVICE AGENTS HEREUNDER OR PURSUANT HERETO I...

Страница 109: ...ther act whatsoever similar to those above enumerated or any other circumstance being beyond the reasonable control of Integra or Customer then and in that event Integra or Customer as the case may be...

Страница 110: ...h screen monitors 80 clinical use laparoscopic handpieces 49 clock symbol about the 43 color codes handpieces 36 compliance standards 93 components list of 20 26 Console cleaning the 74 functionality...

Страница 111: ...uages changing onscreen 71 laparoscopic handpieces 49 Latex free components 31 leakage low frequency 91 left Footswitch pedal see Power Footswitch pedal levels controlling ultrasonic 41 44 M mains inl...

Страница 112: ...terilization procedures handpiece backup handpieces 28 storage compartment Footswitch and power cord 45 stylet clearing blocked handpieces 29 suction ports for tubing 45 suction source determining cur...

Страница 113: ...106 Index This page is intentionally left blank...

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