Misonix neXus User manual

® Ultrasonic
Surgical Aspirator System
Instructions for Use

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 2

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 3
Table of Contents
1. General Safety Statements .............................................................................................................................................................. 4
1.1. EMC Statement ...................................................................................................................................................................... 4
1.2. Electrical Safety Statement ....................................................................................................................................................9
1.3. Environmental Statement......................................................................................................................................................9
1.4. Summary of Safety Notices..................................................................................................................................................10
1.5. Explanation ofSymbols ...................................................................................................................................................... 15
2. Indications and Contraindications ............................................................................................................................................... 18
2.1. Indications for Use ............................................................................................................................................................... 18
2.2. Intended Use Environment..................................................................................................................................................19
2.3. Contraindications.................................................................................................................................................................19
3. Adverse Effects ..............................................................................................................................................................................19
4. Considerations During ClinicalUse ..............................................................................................................................................20
4.1. Hard Tissue Applications/Use (e.g. BoneScalpel Applications)...............................................................................................20
4.2. Wound Debridement Applications / Use (e.g. SonicOne applications) ..................................................................................22
4.3 Soft Tissue Applications / Use (e.g. SonaStar Applications).................................................................................................22
5. System Overview ..........................................................................................................................................................................23
5.1. Principle of Operation.......................................................................................................................................................... 23
5.2. Reusable, Non-Sterile Components..................................................................................................................................... 23
5.3. Single 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 & Functionality........................................................................................................................................... 36
6.10 System Check .......................................................................................................................................................................36
6.11 Footswitch Connectivity & Functionality .............................................................................................................................37
6.12 Powering Down the Console................................................................................................................................................ 40
7. Cleaning Console ..........................................................................................................................................................................41
7.1 Console & Footswitch Cleaning .............................................................................................................................................41
7.2 Single-Use Item Disposal .......................................................................................................................................................41
8. Faults, Indicators & Troubleshooting ..........................................................................................................................................42
8.1 Electrical Faults .......................................................................................................................................................................43
8.2 Mechanical Faults ...................................................................................................................................................................44
8.3 Power Supply Faults ...............................................................................................................................................................45
8.4 Communication Faults ........................................................................................................................................................... 45
8.5 Temperature Faults ................................................................................................................................................................46
8.6 Footswitch Faults ...................................................................................................................................................................46
8.7 Handpiece Faults .................................................................................................................................................................... 47
8.8 Aspiration Troubleshooting ...................................................................................................................................................48
8.9 Irrigation Troubleshooting .....................................................................................................................................................48
9. Specifications ................................................................................................................................................................................ 50
10. Service, Repair andTechnical Correspondence ..........................................................................................................................51

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 4
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 intendedto beusedinvarioustypesofinvasive,surgical
procedures. There may be indirect danger to the patientshould the device fail during the procedure. It is
recommended that the facility follows its back-up equipmentprotocols.
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. TheneXus systemisto be usedbyanappropriatelytrainedandlicensedhealthcare 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: 2014 for emissions and immunity.
CAUTION This device is considered medical electrical equipment. Medical electrical equipment needs special
precautions regarding electromagnetic compatibility (EMC) and needs to be installedand 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 ofaccessories, handpieces andcablesother thanthose specifiedorprovidedbyMisonix may result
in increased electromagnetic emissions ordecreasedimmunity ofthe device andmay result inimproper
operation. Useonly 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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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Electromagnetic Compatibility Guidance (in accordance with EN/IEC 60601-1-2:2014)
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.
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
CISPR 11
Group 1
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.
RF emissions
CISPR 11
Class A
The neXus Ultrasonic Surgical Aspirator System is suitable for
useinall establishments other than domestic andthose directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
o ±8 kV contact
o ±2 kV, ±4 kV, ±8 kV,
±15 kV air
o ±8 kV contact
o ±2 kV, ±4 kV, ±8 kV, ±15 kV
air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
o ±2 kV for power
supply lines
o ±1 kV for
input/outputlines
o ±2 kV for power
supply lines
o ±1 kV for input/output
lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
o ±0.5 kV, ±1 kV
line to line
o ±0.5 kV, ±1 kV, ±2 kV
line to ground
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.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
0 % U
T
(100 % dip in U
T
for 0,5 cycle
70 % UT
(30 % dip in U
T
)
for 25 cycles
0 % UT
(100 % dip in U
T
)
for 1 cycles
0 % U
T
(100 % dip in U
T
)
for 5 sec
0 % U
T
(100 % dip in U
T
) for
0,5 cycle
70 % UT
(30 % dip in U
T
) for 25
cycles
0 % UT
(100 % dip in U
T
) for 1
cycles
0 % U
T
(100 % dip in U
T
) for 5
sec
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.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
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.
NOTE U
T
is the AC mains voltage prior to application of the test level.
NOTE 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

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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 recommendedseparationdistance
calculatedfrom the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
6Vrms in ISM Bands
3 Vrms
150 KHz to 80 MHz
d = 1.2√P
d = 1.2√P 80 MHz to 800MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 Hz to 2.7 GHz
80% AM at 1Khz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1Khz
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 anelectromagneticsitesurvey,
a
should be less than the compliance level in each
frequency range.
b
Interference may occur inthe vicinity ofequipment
marked with the followingsymbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply inall situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects andpeople.
NOTE 3 If a fault notification on the GUI occurs, press the “X” button to exit the screen and initiate system reset.
Table 1.4 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)
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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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 inan electromagnetic environment inwhichradiated
RF disturbances are con- trolled.Thecustomer ortheuserofthe neXus Ultrasonic Surgical Aspirator System can help
prevent electromagneticinterference 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
power
of transmitter
W
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2,7 GHz
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 andpeople.
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 UL 60601-1 and EN 60601-1 .
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 ofelectric shock, this equipment must only be connected to a supply
with protective earth.Install plug andreceptacles 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. Confirmthatthecorrect
fusesarebeingused.Refertosection10 in instructions for fuse replacement .
1.3. Environmental Statement
This equipment consists ofmaterials that may berecycled ifdisassembled 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, p laceresponsibilitiesonthesupplierandyou,thepurchaser/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 havingthesupplierreplace them then they must not be mixed
with unsorted municipal waste. You must ensure that the EEE and/orthebatteriesaredisposed of at anauthorized treatment
facility. Details for special disposal procedures for EEE and/or batteries canbe obtained from your local council.
Table 1.7: Environmental statement

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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 ofthis device should only be performed by qualified technicians authorized by Misonix, Inc.There are no
service controls accessible to theuser.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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 beusedinvarioustypesofinvasive,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 equipmentprotocols.
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.Installplug andreceptacles as per local regulations beforeoperating 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
malfunctionorto create a shock orfire hazard. Refer to the back label on the system console for line voltages and
frequencies.
 Replacementfusesotherthanwhatisspecifiedcancauseafirehazard. 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 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 Hand Switch cable and for monopolar cautery guidelines.
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.
 Tipandirrigation temperatures may exceed the tissue necrosis point ifinsufficient irrigation flow rates are used.
For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable vibration setting.
Forexample, 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 tipis not moved relative to tissue. A continuous, lateral sweeping motion is
recommended inorder 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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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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 externalirrigation,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 beretrieved 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 orcracking
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 foot pedal depression can cause possible 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.
 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
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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
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 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 U.S. federal law restricts this device to sale by, or on the order of a licensed healthcare practitioner.
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 re-
sterilize.
 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.
 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 tissue release 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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 14
 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, 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.
 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 Inc authorized technical personnel. Under normal conditions, the filter should be changed at 6-
month intervals.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 15
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 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 to Temperatures greater than indicated
Do Not expose to Humidity greater than indicated

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 16
Graphic
Images
Description
Foot pedal or button not activated
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

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 17
Graphic
Images
Description
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

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 18
2. Indications and Contraindications
2.1. Indications for Use
The Misonix Inc. 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®
Long and Short Handpiece
for use with SonaStar®
Indications for Use
BoneScalpel ®
Indications for Use
SonicOne ®
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:
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.
Indicated for use in the fragmentation and
aspiration of soft and hard tissue (i.e. bone) in
the following surgical specialty:
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
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
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.

Instructions For Use –neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 19
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 This 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
WARNING The neXus Ultrasonic Surgical Aspirator System and its accessories may emit harmful acoustic pressure if
exposure exceeds recommended limits.
WARNING Tipand irrigation temperatures may exceed the tissue necrosis point ifinsufficient irrigation flow rates
are used. For hard tissue removal, set the irrigation flowrate to a setting no less than the comparable
vibration setting. Forexample, if the vibration setting is 70, a minimum flow setting of70 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 iftipis not moved relative to tissue. A continuous, lateral sweeping motion is
recommended inorder 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.
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