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Instructions For Use – neXus Ultrasonic Surgical Aspirator

  

 

Doc #: 100-10-1000 rev A 

 

 

 

 

 

 

 

 

 

 

p 10 

 

 

1.4.

 

Summary of Safety Notices

 

 

 

Conventions on Warnings andCautions 

 

WARNING

 

Denotes potentially dangerous situation that could result in death or serious injury to patient, operator 
or staff.

 

CAUTION

 

A caution contains information regarding any special care to be exercised by the practitioner and/or 
patient for the safe and effective use of the device.

 

 

Table 1.8: Conventions on warnings and cautions.

Please read this section of the manual carefully. It contains a summary of all precaution, warning and caution statements 
contained in the manual. However, the user is advised to read the entire manual and operate the device only in 
accordance with all of the instructions contained herein.

 

 

Servicing of this device should only be performed by qualified technicians authorized by Misonix, Inc. There are no 
service controls accessible to the user.

 

Содержание neXus

Страница 1: ... Ultrasonic Surgical Aspirator System Instructions for Use ...

Страница 2: ...Instructions For Use neXus Ultrasonic Surgical Aspirator Doc 100 10 1000 rev A p 2 ...

Страница 3: ...gle Use SterileComponents 23 6 Console Setup and Use 24 6 1 Installation 24 6 2 Initial Setup 25 6 3 Power Up and Setup 26 6 4 Tubing Connection 28 6 5 Handpiece Assembly Disassembly 30 6 6 Priming Irrigation Tubing 31 6 7 Main Screen with a Standard Handpiece e g BoneScalpel or SonicOne 32 6 8 Main Screen with a Sonastar Handpiece e g SonaStar Short or SonaStar Long 34 6 9 Mode Selection Function...

Страница 4: ...Instructions For Use neXus Ultrasonic Surgical Aspirator Doc 100 10 1000 rev A p 5 ...

Страница 5: ...uding the use of appropriate personal protection equipment PPE 1 1 EMC Statement The neXus Ultrasonic Surgical Aspirator System is designed and tested to comply with FCC regulations for conducted and radiated emissions under 47 Part 18 Subchapter J and to comply with IEC60601 1 2 2014 for emissions and immunity CAUTION This device is considered medical electrical equipment Medical electrical equip...

Страница 6: ...ble 201 The neXus Ultrasonic Surgical Aspirator System is intended for use in the electromagnetic environment specified below The customer or the user of neXus Ultrasonic Surgical Aspirator System should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The neXus Ultrasonic Surgical Aspirator System uses RF en...

Страница 7: ...at of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 100 dip in UT for 0 5 cycle 70 UT 30 dip in UT for 25 cycles 0 UT 100 dip in UT for 1 cycles 0 UT 100 dip in UT for 5 sec 0 UT 100 dip in UT for 0 5 cycle 70 UT 30 dip in UT for 25 cycles 0 UT 100 dip in UT for 1 cycles 0 UT 100 dip in UT for 5 ...

Страница 8: ... as determined byanelectromagnetic sitesurvey a should be less than the compliance level in each frequency range b Interference mayoccurinthe vicinityofequipment marked with the followingsymbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures o...

Страница 9: ... 0 1 0 38 0 38 0 76 1 1 2 1 2 2 4 10 3 8 3 8 7 6 100 12 12 24 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800...

Страница 10: ...tement This equipment consistsof materials that may berecycled if disassembled by aspecialized company Pleaseobservelocal and federal regulations regarding the disposal of packing materials and old equipment Important Environmental Information for Users within the European Economic Area The European Council Directive 2002 96 EC on Waste Electrical and Electronic Equipment EEE usually referred to a...

Страница 11: ...e practitioner and or patient for the safe and effective use of the device Table 1 8 Conventions on warnings and cautions Please read this section of the manual carefully It contains a summary of all precaution warning and caution statements contained in the manual However the user is advised to read the entire manual and operate the device only in accordance with all of the instructions contained...

Страница 12: ...ntfusesotherthanwhatisspecifiedcancauseafirehazard Useonlyasspecified Explosion Hazard Never use the neXus Ultrasonic Surgical Aspirator System in the presence of a flammable or explosive atmosphere such as flammable anesthetics The neXus Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits Refer to Section 3 of this IFU...

Страница 13: ... hazard Confirm that handpiece connector is dry prior to plugging it in Heat is being generated at the tip tissue interface A continuous lateral sweeping motion is recommended for general bone tissue removal in order to minimize contact duration with the ultrasonic tip and minimize the temperature increase During system check make sure the tip of the handpiece is free from contact with any object ...

Страница 14: ...or Use Manual respectively prior to using either of the handpieces Ultrasonic energy is inhibited if excessive physical force is applied to the ultrasonic tip use only enough force to guide the tip to the surgical site and to advance it through the tissue Do not force the tip allow the ultrasonic action to do the work Insufficient irrigation and high tip pressure loading under extended exposure e ...

Страница 15: ... console housing while in operation or shortly after operation Loose tip tissue contact upon an initial bone incision can cause a thin tip to resonate not only longitudinally but also transversely This can cause a thin tip to break It is necessary to engage bone actively and with a minimal tip pressure greater than zero in order to prevent the shattering Contact of the ultrasonic tip or the expose...

Страница 16: ...tentiality connection Disposal to be com pliant with EN 50419 WEEE directive Authorized representative Type BF Applied Part Power Standby Misonix CE number Classified by UL Serial Number Catalog number AC Voltage Fuse Manufacturer Date of Manufacturer Do not use if packaging is damaged Contents are latex free Restricted to sale by or on the order of a physician only Lot or batch code Do Not expose...

Страница 17: ...ted Foot pedal or button activated Footswitch Communicating with Console Footswitch Not Communicating with Console Low Footswitch Battery Enable Mode Active Standby Mode Active Preset Mode Active Linear Mode Active Vacuum System On Vacuum System Off Irrigation System Lap Endo Mode Off Lap Endo Mode On Exit button to return to the Main screen ...

Страница 18: ...scription System Reset Button Fast Flush Off State Fast Flush On State Initiate Priming Cycle Pause Priming Cycle Resume Prime Irrigation Skip Priming Cycle Handpiece Not Connected Handpiece Connected Tubeset Not Connected Tubeset Connected Irrigation Pump Door Open Irrigation Pump Door Closed Settings ...

Страница 19: ... fallopian tube uterus or the supporting structures of the uterus except as contraindicated for uterine fibroids Thoracic Surgery Limited pulmonary reception such as segmetectomies nonanatomical subsegmentectomies and metastatectomies Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds such as but not limited to burn wounds diabetic ulcers beds...

Страница 20: ...ic pressure if exposure exceeds recommended limits WARNING Tipandirrigationtemperaturesmayexceedthetissue necrosispointifinsufficientirrigation flowrates are used For hard tissue removal set the irrigation flowrate to a setting no less than the comparable vibration setting For example if the vibration setting is 70 a minimum flow setting of 70 should be used Additional external irrigation e g by a...

Страница 21: ...t 100 100 Standard Default 70 70 Lowest 5 5 1 At Amplitude Setting 0 ultrasound if disabled 2 The lowest flow setting is 5 Refer to specifications table for applicable flow rate Table 4 1 1 Hard Bone setting Recommendations A high amplitude setting results in more aggressive tissue removal a low setting in less aggressive tissue removal A higher amplitude setting in combination with lower irrigati...

Страница 22: ... Tips can bend or deform before they actually brake Tips showing signs of deformation or cracking should be replaced immediately since tip breakage is otherwise imminent Do not bend or twist the ultrasonic tips since it reduces the structural integrity and can result in tip breakage during use Dispose of deformed or broken tips immediately in a biohazardous harps container in accordance with your ...

Страница 23: ...chments i e debridement probes etc are considered the applied part 4 3 Soft Tissue Applications Use e g SonaStar Applications Aspiration probes are typically used for soft tissue removal Tissue excision and fragmentation are achieved through cavitation and other mechanical and hydrodynamic effects Recommended Settings The following settings are general guidelines and should be adjusted based on in...

Страница 24: ...switch and cart Misonix recommends the use of EPA certified CaviWipes or equivalent quaternary ammonium compound surface disinfectant wipe Please follow manufacturer s instructions for surface cleaning and disinfection of hard non porous surfaces including without limitation the use of personal Protection Equipment PPE for Bloodborne Pathogens Dispose of the used wipes in accordance with local reg...

Страница 25: ...lly adjusts for the mains voltage and frequency Confirmthatthecorrect fusesarebeingused Refertosection10 in instructions for fuse replacement Care should be taken to stay within the general operating conditions Operating Conditions Operating conditions Temperature 13 30 C 55 86 F Relative humidity 20 90 non condensing Altitude 91m 300ft to 3000m 9842 ft Table 6 1 1 Operating Conditions The console...

Страница 26: ...Vacuum Filter Section 6 3 sets up the irrigation and aspiration lines to the Canister and the IV bag NOTE IV bag should be 1000ml or less Figure 6 2 1 Console rear CAUTION When using optional cart accessory be sure to align the rubber feet on the bottom of the console with the indents in the cart base CAUTION Do not transport the neXus console with the IF bag attached to the IV pole 6 2 5 Obtain t...

Страница 27: ...ug the power cord into a hospital grade outlet Plug the other end of the power cord into the rear of the console Be sure that during use there is sufficient room necessary to disconnect the cord from the console for mains disconnection WARNING Proper system grounding can only be ensured when an approved hospital grade receptacle and matching power cord are used Toavoid the risk of electric shock t...

Страница 28: ...ndpiece receptacle will turn from blue to green and the User Screen will check the handpiece graphics box to indicate the handpiece is correctly connected The handpiece connection allows the neXus console to differentiate between universal handpieces and SonaStar handpieces automatically WARNING Improper connectionofthe handpiececable may present ashock hazard Confirm that handpiece connector is d...

Страница 29: ...on tubing to be aligned with the opening of the irrigation pump and pinch valve accordingly The LEDs on the side of the console will change from blue to green when the pucks are properly positioned Furthermore a check mark will appear next to the Tubing icon on the screen CAUTION Incorrect routing of irrigation tubing will result in no flow of irrigation solution to the tip this may cause damage t...

Страница 30: ...t connection followed by the Priming screen Place the irrigation tubing onto the rollers as shown below The tubing shall lie in the V slots on the right and left side of the pump housing Once positioned close the pump cover The blue LED above the pump head shall change from blue to green A check mark shall appear on the screen next to the water drop icon followed by the Priming screen 6 4 2 1 Irri...

Страница 31: ... 4 2 4 SonaStar Handpiece Tubing Connected CAUTION Aspiration tissue release valve and irrigation pump can create pinch points Keep fingers away from these parts while operating unit Use caution when assembling components 6 5 Handpiece Assembly Disassembly See separate Handpiece IFU s Sonastar IFU 100 24 1000 Standard Handpiece IFU 100 21 1000 ...

Страница 32: ...rise Most ultrasonic tips feature an integrated irrigation channel The irrigation is expelled through a jet nozzle at the tip Active tip surfaces are being cooled directly Figure 6 6 1 Priming Screen Figure 6 6 2 Pause Priming Screen CAUTION Prime the irrigation tubing prior to use At all times ensure that the irrigation flows towards the handpiece when footswitch is depressed If irrigation is not...

Страница 33: ...cOne Pressing the ultrasound Enable button changes the amplitude setting from grey to orange In this mode ultrasound is ready for activation via footswitch Pressing the foot pedal when the setting is orange activates ultrasound and irrigation Pressing the foot pedal when the setting is grey activates irrigation only Figure 6 4 2 Main Screen with Standard Handpiece Connected Ultrasound Enable Stand...

Страница 34: ...amount of footswitch travel i e gas pedal 6 7 3 2 Irrigation Controls The BLUE display controls Irrigation Proper irrigation with sterile saline ensures 1 Cooling of handpiece and vibratingelements 2 Cooling and lavage of the surgicalsite 3 Lubrication of bone tip interface for hard tissue removal The active ultrasonic probe remains cold when not in contact with tissue However when a tip contacts ...

Страница 35: ...anges the amplitude setting from grey to orange In this mode ultrasound is ready for activation via footswitch Pressing the foot pedal when the setting is orange activates ultrasound and irrigation Pressing the foot pedal when the setting is grey activates irrigation only Figure 6 5 2 Main Screen Sonastar Ultrasound Enable Standby Grey Standby Fast Flush Preset Linear Aspiration Controls Footswitc...

Страница 36: ...lease valve is closed and there is no vacuum present at the tip This is to prevent the irrigation fluid from immediately being aspirated before reaching the surgical site When the FLUSH button is released the valve re opens allowing vacuum to be present at the tip When the LAP Mode has been chosen the aspiration system works as described above for each function When the footswitch is depressed the...

Страница 37: ... depressed it opens for tissue removal into the canister 6 10 System Check After preparing the system for use a System Check should be performed prior to use ensuring proper functionality Upon success completion of the System check as described below the neXus Ultrasonic Surgical Aspirator System is now ready for use System Check Enable Ultrasound Switch to Enable Mode using enable standby button ...

Страница 38: ...ble injury to the patient surgeon or operating room staff and can damage the product Place foot pedal where it is highly visible and labels can be clearly seen WARNING Do not lay the handpiece on the patient when not in use When not in use keep the handpiece on a dry non conductive surface with the tip free from contact with any object 6 11 Footswitch Connectivity Functionality 6 11 1 Footswitch C...

Страница 39: ... battery is low an alert will appear on the screen see Troubleshooting section 8 2 6 For battery replacement see section 10 3 6 11 3 Pairing the Footswitch to the Console The nexus footswitch is paired to the console prior to delivery to the end customer If a replacement footswitch is required the following 5 steps are required to pair the footswitch to the console Step 1 Power up the console and ...

Страница 40: ...2 seconds The Pairing LED shall be illuminated Wait until Pairing and Connected LED s on the screen are illuminated Console Touch Point Footswitch Pairing Point to Console Pairing Point Step 4 The green Paired and Connected LED s on the screen confirms that pairing is complete Step 5 Verify that the footswitch is connected to the console by depressing footpedal The footswitch icon shall turn green...

Страница 41: ...ce is already setup the Main screen shall appear To completely tear down the console follow the steps in the table below Console Tear Down Procedure Disable Ultrasound Footpedal NOT depressed Remover power Unplug Mains power cord from the rear of the console Remove Handpiece Cable Pull cable connector from receptacle on console front Remove Tubing Open pump cover Remove tubing from pump compartmen...

Страница 42: ...nsmission of disease do not attempt to reprocess clean re sterilize and or reuse these items WARNING The disposable items are intended for one procedure only single use Do not attempt to reuse or re sterilize Caution Only external surfaces of the console should be cleaned Do not attempt to remove any panels in order to clean or disinfect internal surfaces Caution Do not immerse ultrasonic console ...

Страница 43: ...se or adjustment of this device may invalidate the Misonix Inc Warranty agreement Contact your authorized Misonix Inc representative before attempting to troubleshoot this device in any manner other than those specified in this manual There are no user serviceable parts Fault Type Fault Indicator Fault Action System Reset Example screen Fault screen also triggers a pulsed audible indicator System ...

Страница 44: ...eps above are followed and fault continues the console may need to be replaced Table 8 1 Electrical Faults WARNING Immediately suspend operation if a persistent Electrical Fault appears on display and or an Electrical Fault audible indicator sounds Remove ultrasonic tip from surgical site Do not touch any metallic parts of handpiece extension ultrasonic tip or generator while fault is indicated WA...

Страница 45: ... action below Fault Type Fault Screen Fault Action Notification Frequency Fault System functions remain enabled while Notification is displayed Possible Cause Corrective Action Tip Overload Reducing tip pressure will automatically clear the Notification without releasing the footpedal or release footpedal and try again If problem persists use higheramplitudesetting asrequired Loose or damaged comp...

Страница 46: ...n If corrective action steps above are followed and fault continues the console may need to be replaced Table 8 3 Power Supply Faults 8 4 Communication Faults The console monitors the internal microprocessors at all times and faults in cases when they are not communicating properly A System Reset screen is displayed together with an audible indicator Ultrasound and Irrigation are deactivated Fault...

Страница 47: ...ct that the vents under the display and in the rear of the console are not blocked Press the System Reset Button and try again If corrective action steps above are followed and fault continues let the unit cool down and try again Table 8 5 Temperature Faults 8 6 Footswitch Faults 8 6 1 Footswitch Low Battery Notification The footswitch is powered with an AA alkaline battery If the battery voltage ...

Страница 48: ...e If corrective action steps above are followed and fault continues the footswitch may need to be replaced Contact Misonix Service Center Table 8 6 2 Footswitch Connection Lost Notification 8 7 Handpiece Faults The console has the ability to recognize the handpiece that is connected to the console If the handpiece cannot be recognized the console will display a fault notification As a result the c...

Страница 49: ...n 1 Closed or empty fluid bag Set ultrasound to STANDBY Check fluid bag and tubing clamp Replace fluid bag if necessary 2 Tubing not connected Set ultrasound to STANDBY Check tubing connections Check mounting in pump head Close pump cover until locked 3 Tubing obstructed or defective Set ultrasound to STANDBY Check tubing for kinking restrictions or leaks Replace tubing if necessary Check mounting...

Страница 50: ...tissue removal set the irrigation flowrate to a setting no less than the comparable vibration setting For example if the vibration setting is 70 a minimum flow setting of 70 should be used WARNING Do not operate pump with pump cover in raised position Rollers might pinch loose clothing or fingers Personal injuries may result For all other malfunctions please contact Misonix or a Misonix authorized...

Страница 51: ... US Canada Ground leakage current 500 µA max Vibration System Continuous Wave Frequency 22 5Khz Footswitch IPX8 Internally powered Console IPX1 Operating conditions Temperature 13 30 C 55 86 F Relative humidity 20 90 non condensing 91m 300ft to 3000m 9842ft Shipping storage conditions Temperature 20 to 50 C 4 to 122 F Relative humidity 15 90 non condensing Dimensions Console w o canister 11 5 H x ...

Страница 52: ...s within the console itself and the connected handpiece To avoid injury the console should never be operated before ensuring that its cover is properly closed and not tampered with Do not attempt to remove or disassemble the cover There are no user serviceable parts inside the console All service should only be performed by an authorized Misonix representative No modification of this equipment is ...

Страница 53: ...r of the console Remove Fuse Holder Pinch the tab on each side of the fuse holder Pull fuse holder out Replace Fuses and reinsert holder into socket Replace both fuses as specified above and insert holder into the socket A click shall be heard Connect power cord to the rear of the console neXus Splash screen shall appear followed by the setup screen Table 10 2 Console Fuse Replacement ...

Страница 54: ...to reinstall Figure 10 1 Push Tabs inward Figure 10 2 Pull out filter 10 3 Footswitch Battery Replacement The Wireless footswitch is powered by one AA alkaline battery Replace with only NEW battery CAUTION The neXus device will alert the user if the batteries in the footswitch are low Replace batteries immediately following the procedure Open the battery compartment by turning the cap counter cloc...

Страница 55: ...licable warranty CAUTION Before using loose packing materials such as foam pellets shredded paper or similar be sure to wrap the component s separately in plastic bags film or other protective wrapping WARNING No Modifications of this equipment is allowed except as noted for cleaning and sterilization The user should return to Misonix or an authorized service center WARNING The NeXus Ultrasonic Su...

Страница 56: ...red free of any hazardous or noxious matter or radioactive contamination and are safe for handling under normal repair shop conditions Do not return any material for which such certification cannot be made without prior approval from Misonix Inc The correct return address should read as follows Misonix Medical Service Department RMA 1938 New Highway Farmingdale NY 11735 Please contact Misonix for ...

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