nexus Ultrasonic Surgical Aspirator Instructions for Use

Table of Contents 1.

General Safety Statements ... 5 1.1. EMC Statement ... 5 1.2. Electrical Safety Statement ... 10 1.3. Environmental Statement ... 10 1.4. Summary of Safety Notices ... 11 1.5. Explanation of Symbols ... 15 2. Indications and Contraindications... 20 2.1. Indications for Use ... 20 2.2. Intended Use Environment ... 21 2.3. Contraindications... 21 3. Adverse Effects ... 21 4. Considerations During Clinical Use ... 22 4.1 Hard Tissue Applications/Use (e.g. BoneScalpel® Applications) ... 22 4.2 Wound Debridement Applications / Use (e.g. SonicOne® applications)... 24 4.3 Soft Tissue Applications / Use (e.g. SonaStar® Applications) ... 24 5. System Overview ... 25 5.1. Principle of Operation... 25 5.2. Reusable, Non-Sterile Components ... 25 5.3. Single Use, Sterile Components ... 25 6. Console Setup and Use ... 26 6.1. Installation ... 26 6.2. Initial Setup ... 27 6.3 Power Up and Setup ... 28 6.4 Tubing Connection ... 30 6.5 Handpiece Assembly & Disassembly ... 31 6.6 Priming Irrigation Tubing ... 32 6.7 Main Screen with a Standard Handpiece (e.g. BoneScalpel® or SonicOne®) ... 33 6.8 Main Screen with a SonaStar® Handpiece (e.g. SonaStar® Short or SonaStar® Long) ... 35 6.9 Mode Selection & Functionality... 37 6.10 System Check ... 37 6.10.1 Software Version Information ... 38 6.11 Footswitch Connectivity & Functionality ... 39 6.12 Console Disassembly... 43 7. Cleaning Console ... 44 7.1 Console & Footswitch Cleaning ... 44 7.2 Single-Use Item Disposal ... 44 8. Faults, Indicators & Troubleshooting ... 45 8.1 Electrical Faults ... 46 8.2 Mechanical Faults ... 47 8.3 Power Supply Faults ... 48 8.4 Communication Faults ... 48 8.5 Temperature Faults ... 49 8.6 Footswitch Faults ... 49 8.7 Handpiece Faults ... 52 8.9 Aspiration Troubleshooting ... 53 8.10 Irrigation Troubleshooting... 54 9. Specifications ... 55 10. Service, Repair andTechnical Correspondence ... 56 11. Repair, Service and Replacement Parts ... 58

Instructions For Use – neXus® Ultrasonic Surgical Aspirator Doc #: 100-10-1000 EU rev (-) March 2023

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1. General Safety Statements WARNING

The neXus® Ultrasonic Surgical Aspirator System is an electro-mechanical device, which under certain circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions stated herein to assure maximum safety during operation. This manual shall be kept in close proximity to the system for easy referral when needed.

WARNING

The neXus® Ultrasonic Surgical Aspirator System is intended to be used in various types of invasive, surgical procedures. There may be indirect danger to the patient should the device fail during the procedure. It is recommended that the facility follows its back-up equipment protocols.

CAUTION

Special Skills Training Requirements 1. U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner. 2. The neXus® system is to be used by an appropriately trained and licensed healthcare practitioner. 3. Prior to using the neXus® system, all healthcare practitioners are to be trained in the institution’s procedures for blood borne pathogen (BBP) universal precautions, including 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 and BS EN 60601-1-2: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances- Requirements for Tests.

CAUTION

This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator’s manual.

WARNING

Portable and mobile RF communication equipment (including peripherals such as antennas) should be no closer than 30 cm (12 inches) to any part of the neXus®, including the cables supplied with the neXus® Otherwise degradation of the performance of this equipment could result.

WARNING

The use of accessories, handpieces and cables other than those specified or provided by Misonix may result in increased electromagnetic emissions or decreased immunity of the device and may result in improper operation. Use only Misonix branded equipment and accessories.

WARNING

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

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Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2014) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions (Table 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

Group 1

CISPR 11 RF emissions

The neXus® Ultrasonic Surgical Aspirator System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A

CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions

Class A

The neXus® Ultrasonic Surgical Aspirator System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Complies

IEC 61000-3-3 Table 1.1 Guidance & manufacturer’s declaration on electromagnetic emissions (EN table 201)

Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals. If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Table 202) The neXus® Ultrasonic Surgical Aspirator System is intended for use in the electromagnetic environment specified below. The customer or the user of the neXus® Ultrasonic Surgical Aspirator System should assure that it is used in such an environment. IEC 60601 Immunity test Compliance level Electromagnetic environment – test level guidance Electrostatic discharge Floors should be wood, concrete or o ±8 kV contact o ±8 kV contact (ESD) o ±2 kV, ±4 kV, ±8 kV, ±15 kV ceramic tile. If floors are covered with o ±2 kV, ±4 kV, ±8 kV, synthetic material, the relative humidity IEC 61000-4-2 air ±15 kV air should be at least 30%. Electrical fast transient/ o ±2 kV for power o ±2 kV for power Mains power quality should be that of burst supply lines supply lines a typical commercial or hospital environment. o ±1 kV for input/output IEC 61000-4-4 o ±1 kV for lines input/output lines o ±0.5 kV, ±1 kV line to line

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 NOTE NOTE

o ±0.5 kV, ±1 kV, ±2 kV line to ground 0 % UT (100 % dip in UT for 0,5 cycle

o ±0.5 kV, ±1 kV line to line o ±0.5 kV, ±1 kV, ±2 kV line to ground

Mains power quality should be that of a typical commercial or hospital environment.

0 % UT (100 % dip in UT) for 0,5 cycle

Mains power quality should be that of a typical commercial or hospital environment. If the user of the neXus® Ultrasonic Surgical Aspirator System requires continued operation during power mains interruptions, it is recommended that the powered from an uninterruptible power supply.

70 % UT (30 % dip in UT) for 25 cycles

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 1 cycles

0 % UT (100 % dip in UT) for 5 sec

0 % UT (100 % dip in UT) for 5 sec

30 A/m

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

UT is the AC mains voltage prior to application of the test level. If a fault notification on the GUI occurs, press the “X” button to exit the screen and initiate system reset.

Table 1.2 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 202)

List of Cables Item

Cable Length

Type

Handpiece cable

15 ft | 4.6 m

shielded 2-conductor

Power cord

10 ft | 3.0 m

unshielded 3-conducter

Monopolar Hand Switch Cable

15.5 ft | 4.7 m

unshielded 3-conducter

Table 1.3 List of cables

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Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Table 204) The neXus® Ultrasonic Surgical Aspirator System is intended for use in the electromagnetic environment specified below. The customer or the user of the neXus® Ultrasonic Surgical Aspirator System should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the neXus® Ultrasonic System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz 6Vrms in ISM Bands

3 V/m 80 Hz to 2.7 GHz 80% AM at 1Khz

3 Vrms 150 KHz to 80 MHz

3 V/m 80 MHz to 2.7 GHz 80% AM at 1Khz

d = 1.2√P d = 1.2√P

80 MHz to 800 MHz

d = 2.4√P

800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

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, objects and people. NOTE 3 If a fault notification on the GUI occurs, press the “X” button to exit the screen and initiate system reset.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the neXus® Ultrasonic Surgical Aspirator System is used exceeds the applicable RF compliance level above, the neXus® Ultrasonic Surgical Aspirator System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the neXus® Ultrasonic System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Table 1.4 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)

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Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the neXus® Ultrasonic Surgical Aspirator System (Table 206) The neXus® Ultrasonic Surgical Aspirator System is intended for use in an electromagnetic environment in which radiated RF disturbances are con- trolled. The customer or the user of the neXus® Ultrasonic Surgical Aspirator System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the neXus® Ultrasonic Surgical Aspirator System below, according to the maximum output power of the communications equipment. Rated maximum output Separation distance according to frequency of transmitter power (m) of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,7 GHz W d = 1.2√P d = 1.2√P d = 2.4√P 0.01

0.12

0.12

0.24

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 MHz, the separation distance for 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, objects and people. Table 1.5 Recommended separation distances (EN table 206)

Characteristics of Wireless Footswitch Receiver Frequency Band of reception

2400 – 2483.5Mhz

Preferred Frequency band of reception

No preference

Bandwidth of receiving section of the frequency bands

5Mhz

Frequency band of transmission

2400 – 2483.5Mhz

Frequency characteristics of the modulation

GPSK modulation

Effective radiated power

-2.22dBm (0.60mW) max, 1.3dBi antenna gain, -0.92dBm EIRP Table 1.6: Characteristics of Wireless footswitch receiver

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1.2. Electrical Safety Statement The neXus® Ultrasonic Surgical Aspirator System is designed and tested to comply with IEC 60601-1, UL 60601-1 and BS EN 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance.

WARNING

The neXus® Ultrasonic Surgical Aspirator System generates high voltages 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 required.

WARNING

Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.

WARNING

The neXus® console automatically adjusts for the mains voltage and frequency. Confirm that the correct fuses are being used. Refer to section 10 in instructions for fuse replacement.

1.3. Environmental Statement This equipment consists of materials that may be recycled if disassembled by a specialized company. Please observe local 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 as WEEE Directive, place responsibilities on the supplier and you, the purchaser/user to dispose of electrical and electronic equipment properly. One of the actions required for a supplier is to inform users of their obligations. The WEEE Directive requires that the EEE be disposed of at the end of its useful life in an environmentally responsible manner. The WEEE Directive requires that if replacing the EEE with a new equivalent product, the supplier shall collect the old item without cost to the user. In a similar fashion, Directive 2006/66/EC on Batteries requires that batteries be disposed of at the end of their useful life in an environmentally responsible manner. The Directive on Batteries requires that when replacing batteries with new or equivalent batteries, the supplier shall collect the old batteries without cost to the user. If you wish to dispose of the EEE and/or the batteries without having the supplier replace them then they must not be mixed with unsorted municipal waste. You must ensure that the EEE and /or the batteries are disposed of at an authorized treatment facility. Details for special disposal procedures for EEE and/or batteries can be obtained from your local council.

Table 1.7: Environmental statement

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1.4. Summary of Safety Notices 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, LLC.. There are no service controls accessible to the user.

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.

1.4.1 List of Warnings 

The neXus® Ultrasonic Surgical Aspirator System is an electro-mechanical device, which under certain circumstances could present an electrical shock hazard to the operator and/or patient. Please read manual thoroughly and follow directions stated herein to assure maximum safety during operation. This manual shall be kept in close proximity to the system for easy referral when needed.



The neXus® Ultrasonic Surgical Aspirator System is intended to be used in various types of invasive, surgical procedures. There may be indirect danger to the patient should the device fail during the procedure. It is recommended that the facility follows its back-up equipment protocols.



The neXus® Ultrasonic Surgical Aspirator System generates high voltages 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 required.



Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.



Connecting the console to a power outlet with inadequate voltage or frequency may cause the unit to malfunction or to create a shock or fire hazard. Refer to the back label on the system console for line voltages and frequencies.



Replacement fuses other than what is specified can cause a fire hazard. Use only as specified.



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 for exposure limit.



Only use the Standard Handpiece with BoneScalpel® or SonicOne® OR probe accessory kit configurations for the indications for use charted in Section 2.1 for the Standard Handpiece.



Only use the SonaStar® Long and Short Handpieces with SonaStar® probe accessory kit configurations for the indications for use charted in Section 2.1 for the SonaStar® Handpieces.



The SonaStar® Long and Short Handpieces may combined with electrosurgery using an optional RF Monopolar fingerswitch cable. Refer to the SonaStar® Handpiece IFU for detailed instructions for using the RF Monoplar Handswitch cable and for monopolar cautery guidelines.

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

The neXus® Long or Short Handpieces can deliver RF energy via its attached probe tip when connected to a 3rd party electrosurgical generator using the RF Monopolar Handswitch Cable accessory. Misonix recommends use of the electrosurgical generators listed in Table 4.5 of the SonaStar® Long and Shot Handpiece IFU that have been validated for compatibility with the neXus® system.



Tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used. For hard tissue removal, set the irrigation flow rate 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 administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.



Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up. When lateral motion is not possible withdraw and re-insert tip frequently.



Contact with vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all means. The handpiece should only be held at the black housing area. An optional, protective silicone sleeve, included with certain tips, reduces the risk of thermal damage but does not eliminate it. Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure. Pressure and extended exposure can still result in excessive frictional heat and cause burns.



Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures of the skull, when using the neXus® Ultrasonic Surgical Aspirator System accessories.



Ultrasonic tips can break under excessive use in extreme conditions, e.g. when cutting for extended / duration in tight cavities with limited lateral motion. The tip could break into two or more fragments with the main fragment remaining attached to the handpiece. All fragments must be retrieved immediately from the surgical site. The fragments should be checked to ensure that no further pieces are missing. It is possible that a fragment is propelled outside of the surgical cavity. Diagnostic imaging, such as X-ray, must be used if a fragment cannot be found to confirm that the broken piece is outside of the surgical cavity.



Breakage of ultrasonic tips will result in sharp edges that can be harmful to soft tissue even without activation of ultrasound. 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 sharps container in accordance with your facility biological hazardous waste procedure.



Do not operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers. Personal injuries may result.



Improper connection of the handpiece cable may present a shock 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. Allowing contact with the tip may result in damage and/or personal injury



Inadvertent or improper footswitch depression can cause possible injury to the patient, surgeon, or operating room staff and can damage the product. Place footswitch where it is highly visible and labels can be clearly seen.



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 objects.



Remove probe cover, ultrasonic tip and extension from the handpiece prior to cleaning and/or sterilization; otherwise proper cleaning/sterilization may be inhibited.



Single-use items (tips, sheaths, tubing sets) are marked with the international symbol for “do not reuse single use only” ( ). Discard these items following each surgical procedure in accordance with the hospital protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container. To prevent the risk of malfunction and transmission of disease, do not attempt to reprocess, clean, resterilize, and/or

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reuse these items. 

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. Turn Mains Power OFF. Do not touch any metallic parts of handpiece, extension, ultrasonic tip or generator while fault is indicated.



Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power cord, plug and receptacle should be examined to verify that they are in good working condition before connecting the console. Never pull on the power cord to remove it from the receptacle.



If a Mains Power fuse fails after replacement when the unit is reactivated, discontinue use of the device and contact an authorized Misonix representative.



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.

1.4.2 List of Cautions 

Special Skills Training Requirements o

Caution: U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner. Not applicable in the European Union.

o The neXus® Ultrasonic Surgical Aspirator System is to be used by an appropriately trained and licensed healthcare practitioner. o Prior to using the neXus® system, all healthcare practitioners are to be trained in the institution’s procedures for blood borne pathogen (BBP) universal precautions, including the use of appropriate personal protection equipment (PPE). 

This device is considered medical electrical equipment. Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this operator’s manual.



Portable and mobile RF communication equipment can affect medical electrical equipment. If RF equipment is in use monitor the neXus® Ultrasonic Surgical Aspirator System for proper function during procedure.



The use of accessories, transducers and cables other than those specified may result in increased emissions or decreased immunity of the device. Use only Misonix branded equipment and accessories.



When used adjacent to the other electrical equipment, the console should be observed to verify normal operation in the configuration in which it will be used.



This Instructions for Use Manual provides instructions on using the neXus® Console. Refer to the Standard Handpiece Instructions for Use Manual or the SonaStar® Long and Short Handpiece Instructions for 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.g. in tight cavities, are to be avoided in hard tissue removal. It is recommended to withdraw and re-insert the ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.



Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures of the skull, when using the neXus® Ultrasonic Surgical Aspirator System accessories.



The disposable items are intended for one procedure only (single use). Do not attempt to reuse or resterilize.



Do not place the soft silicone tube behind or in front of the rollers (latch removed in illustrations)



Do not pinch the soft silicone tube when the latch is locked.



Do not pinch barb fittings when closing the latch.

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

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 flowing, cease use until flow is restored.



The system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.



It is strongly advised that a sterile backup handpiece be readily available in the operating room as insurance any contamination or malfunction of the handpiece used during surgery.



Aspiration pinch valve and irrigation pump can create pinch points. Keep fingers away from these parts while operating unit. Use caution when assembling components.



Incorrect routing of irrigation tubing will result in no flow of irrigation solution to the tip; this may cause damage to the handpiece.



Use of a separate monopolar instrument at electrosurgery settings greater than 70W while simultaneously touching the handpiece probe to tissue can induce faults and possible system damage.



Only external surfaces of the console should be cleaned. Do not attempt to remove any panels in order to clean or disinfect internal surfaces.



Do not immerse ultrasonic console, handpiece, irrigation pump or electric cables. These items are not sealed against liquids and damage to equipment will result.



Improper use or adjustment of this device may invalidate the Misonix, LLC. Warranty agreement. Contact your authorized Misonix, LLC. representative before attempting to troubleshoot this device in any manner other than those specified in this manual. There are no user serviceable parts.



The only user replaceable fuses are the two fuses located on the bottom rear of the unit. Replacement fuses must be identical in type, voltage rating and current rating to the original fuse.



Use only genuine replacement parts from Misonix. Use of parts furnished by other sources may result in patient or operator injury or system malfunction and will void any applicable warranty.



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.



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



After extended periods of operation, the bottom of the console housing may become warm to the touch. This is normal. Do not touch the bottom of the 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 exposed extension with metal, surgical instruments or other objects during ultrasound use must be avoided. Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure. Discard any extensions or tips that show signs of damages like gouges, nicks or fractures. External aspiration may be used but it is recommended that a plastic suction tip should be used when in proximity with the probe tip.



Adequate air circulation is needed to cool electronic components inside of the unit. Do not block the cooling fan at the console rear or the air vents on the console bottom. Do not place the unit on a towel, foam or other soft surface since the material may block the air vents. Blocking these vents may cause unit to overheat and malfunction or create a shock hazard. A clear drape can be used to protect the console front panel but do not cover the pump housing or other console portions.



The neXus® system should be fully tested and inspected prior to each procedure. The console, footswitch, handpieces, all cables and accessories should be examined for proper appearance and condition.



The neXus® device will alert the user if the batteries in the footswitch are low. Replace batteries immediately following the procedure.



All periodic maintenance is to be performed by the hospital’s technical staff, trained OR staff member or by a Misonix, LLC. authorized technical personnel. Under normal conditions, the filter should be changed at 6month intervals.

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1.5. Explanation of Symbols Table 1.5.1: Symbol Definitions

Symbol

Description Caution: Consult accompanying documents Caution: Do Not operate with cover in the raised position Protective earth ground Equipotentiality connection Disposal to be compliant 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 Country of Origin 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 to Temperatures greater than indicated

Do Not expose to Humidity greater than indicated Single sterile barrier system Sterilized using Ethylene Oxide

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Unique Device Identificationis specific to a manufacturer and a device Identifies product as a medical device Single use (Do not re-use) Do not re-sterilize Non-sterile medical device

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Graphic Images

Description Wireless Footswitch not activated Wireless Footswitch or Flush button activated Wired Footpedal connected (not activated) Wired Footpedal activated Wireless Footswitch connected to console Footswitch Not connected to Console, Flashing “X” 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 System Information

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Graphic Images

Description

Service Mode

Footswitch Settings

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

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Graphic Images

Description

Irrigation Pump Door Closed

Settings

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2. Indications and Contraindications 2.1. Indications for Use The Misonix, LLC.. neXus®® Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel®® and SonicOne®® OR probe kit accessory configurations and the indications for the SonaStar®® long and short handpiece in combination with SonaStar®® probe kit accessory configurations are charted below.

NEXUS® INDICATIONS FOR USE BY HANDPIECE AND PROBE KIT ACCESSORY COMBINATION Standard Handpiece for use with BoneScalpel®® and Sonic One® Indications for Use Indications for Use BoneScalpel® ® SonicOne® ®

Long and Short Handpiece for use with SonaStar®® Indications for Use SonaStar®®

Indicated for use in the fragmentation and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties:

Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:

Indicated for use in the fragmentation, emulsification and aspiration of both soft and hard (i.e. bone) tissue in the following surgical specialties:

 Neurosurgery  Gastrointestinal and Affiliated Organ Surgery  Urological Surgery  Plastic and Reconstructive Surgery  General Surgery  Orthopedic Surgery  Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, 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, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

 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, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.  Plastic and Reconstructive Surgery

   

Neurosurgery Gastrointestinal and Affiliated Organ Surgery Urological Surgery Plastic and Reconstructive Surgery General Surgery  Orthopedic Surgery  Gynecological Surgery except as contraindicated for uterine fibroids.  Thoracic Surgery  Laparoscopic Surgery  Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF surgery interface components.

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2.2. Intended Use Environment 

Operating room environment

2.3. Contraindications 2.2.1 The neXus® Ultrasonic Surgical Aspirator System probe tips are not indicated for and should not be used for direct contact with cardiac tissue (direct cardiac application). 2.2.2 The irrigation pump is not indicated for and should not be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes. 2.2.3 The neXus® Ultrasonic Surgical Aspirator System device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

3. Adverse Effects Limits For Airborne Acoustic Exposure Distance from operator’s or patient’s ear

Maximum Exposure Period Within a 24 hour period

3” - 24”

8 cm – 60 cm

28 minutes

> 24”

> 60 cm

287 minutes

Table 3.1: Limits For Airborne Acoustic Exposure

WARNING

The neXus® Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits.

WARNING

Tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used. For hard tissue removal, set the irrigation flow rate 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 administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.

WARNING

Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up. When lateral motion is not possible withdraw and re-insert tip frequently.

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4. Considerations During Clinical Use WARNING

The neXus® Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if exposure exceeds recommended limits. Refer to Section 3 for exposure limits.

WARNING

Contact to vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all means. The handpiece should only be held at the black housing area. A protective silicone sleeve, included with certain tips, reduces the risk of thermal damage but does not eliminate it. Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure. Pressure and extended exposure can still result in excessive frictional heat and cause burns.

CAUTION

After extended periods of operation, the bottom of the console housing may become warm to the touch. This is normal. Do not touch the bottom of the console housing while in operation or shortly after operation.

4.1 Hard Tissue Applications/Use (e.g. BoneScalpel® Applications) Recommended Settings The following settings are general guidelines and should be adjusted based on indication, anatomy, pathology and surgeon’s preference.

Tissue Effect

1Amplitude Setting

2Flow Setting

Highest

100

100

Standard (Default)

70

70

Lowest

5

5

1 – At Amplitude Setting = 0, ultrasound is disabled 2 – The lowest flow setting is 5, Refer to specifications table for applicable flow rate.

Table 4.1: 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 irrigation could result in tissue necrosis. A lower amplitude setting in combination with higher irrigation would reduce the potential for tissue necrosis. The various disposable attachments (i.e. blades, Shavers, probes, etc.) are considered the applied part. Bone shaving tips tend to require a lower amplitude than cutting blades.

WARNING

Tip and irrigation temperatures may exceed the tissue necrosis point if insufficient irrigation flow rates are used. For hard tissue removal, set the irrigation flow rate 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 administering sterile saline with a syringe over the distal tip portion, may be necessary for removal of very dense, hard osseous structures.

WARNING

Tissue necrosis may result if tip is not moved relative to tissue. A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic tip and minimize heat build-up. When lateral motion is not possible withdraw and re-insert tip frequently.

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