Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A p 20
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. 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.
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.
1 – At Amplitude Setting = 0, ultrasound if disabled
2 – The lowest flow setting is 5, Refer to specifications table for applicable flow rate.
Table 4.1.1: 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 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.
To Next Page
Loading...