Alara - GE Vivid i User Manual

Safety
The Vivid i chooses the correct category based on mode of
operation and chosen application, and presents only one TI to
the operator. It is therefore important that the operator chooses
the right application.
The Vivid i has an internal limit of 4.0 on TI. IEC87 has
suggested some time dependent thresholds that are partly
implemented on the Vivid i as color-coding of the thermal
index. The color-coding scheme together with the thermal
exposure times in the table below are not meant as limits on TI
or exposure time, but as an aid for the operator. Note that the
Vivid i does not monitor the thermal exposure time. The
displayed TI is coded as follow:
TI Color
0.0–0.4 Dimmed
0.4–1.5 White
1.5–2.0 White
2.0–3.0 White
3.0–4.0 Red
The maximum possible MI and Ispta on the Vivid i is within the
limits set in Track 3 in the FDA 510(k) guide of 1997, MI < 1.9
and Ispta < 720 mW/cm

ALARA

Ultrasound procedures should be performed using output
levels and exposure times As Low As Reasonably Achievable
(ALARA) while acquiring clinical information.
Training
During each ultrasound examination the user is expected to
weigh the medical benefit of the diagnostic information that
would be obtained against the risk of potential harmful effects.
Once an optimal image is achieved, the need for increasing
acoustic output or prolonging the exposure cannot be justified.
It is recommended that all users receive proper training in
applications before performing them in a clinical setting.
354
Recommended thermal exposure time
-
-
< 12 h
< 1 h
< 15 min.
2
.
Vivid i User's Manual
2378958-100 Rev. 02