Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 11
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 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 3
rd
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 flowrate to a setting no less than the comparable vibration setting.
For example, if the vibration setting is 70, a minimum flow setting of 70% should be used. Additional external
irrigation, e.g. by 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.
