Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 13
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.
