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 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.
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.
Limits For Airborne Acoustic Exposure
Distance from operator’s
or patient’s ear
Maximum Exposure Period
Within a 24 hour period
To Next Page
Loading...
