E-SOUM-PLUS Rev E
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WARNING 3.4
For the Wide Hatch Probe: Less than 50” (127 cm) tall patients to wear ear protection during debridement.
All other patients are to wear ear protection only for upper body debridement.
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
4.
Considerations During Clinical Use
WARNING 4.1
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.
NOTE 4.1
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. SonicOne CLINIC Use
Recommended Settings
The following settings are general guidelines and should be adjusted based on indication, anatomy, pathology and surgeon’s
preference.
Amplitude
Pulse
Flow
Highest
10
100%
100%
Very High
9
100%
90%
High
8
100%
80%
Standard (Default)
7
100%
70%
Moderate
6
100%
60%
Low
5
100%
50%
Table 4.1 Recommended settings
•
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 increased tissue necrosis. A lower
amplitude setting in combination with higher irrigation would minimize or eliminate tissue necrosis.
•
Lower pulse allows for resting periods inserted within the duty cycles
Bone shaving tips tend to require a lower amplitude than cutting blades
