Flosonics Medical FloPatch FP120, Руководство пользователя, Страница: 31 / 33

User Manual – FloPatch FP120
Rev 1.0
CONFIDENTIAL UNCONTROLLED UNLESS OTHERWISE SIGNED AND/OR STAMPED. Page 31 / 33
9.7.4 Prudent Use Statement
Although no confirmed bioeffects on patients caused by exposure from present diagnostic
ultrasound equipment have ever been reported, the potential exists that such bioeffects may be
identified in the future. Therefore, the ultrasound should be used prudently. High levels of acoustic
output and long exposure time should be avoided while acquiring necessary clinical information.
9.7.5 References for Acoustic Output Safety
1. Medical Ultrasound Safety, Third Edition, published by AIUM in 2014
2. Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Devices; Document issued on: September 9, 2008 by the FDA
3. Draft Document: Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Devices; Document issued on: October 2, 2017 by the FDA
4.
IEC 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
Edition 2.1 published in 2015.
9.7.6 Summary of Global Max Values
NOTE: Thermal Indices and the Mechanical Index are 1.0 or less for all device settings. (there is
only a single setting in the device which cannot be altered by the user)
These values have been averaged over 3 probes.
Quantity (
x) K x¯ σ
x
L
1
upper bound γ
x
L
2
upper bound
MI 4.26 0.0111 0.00146 0.0173 0.00156 0.0178
I
spta, α
4.26 15.8 3.83 32.1 4.12 33.3
TIS 4.26 0.297 0.0209 0.386 0.0359 0.45
TIB 4.26 0.323 0.0408 0.497 0.0517 0.543
TIC 4.26 0.48 0.0301 0.608 0.056 0.718
9.7.7 IEC 60601-2-37, Ed 2.1 Reporting Table
Index label
MI TIS TIB TIC
At
surface
Below
surface
At
surface
Below
surface
Maximum index value
1.11E
-02
0.30 0.32 0.48
Index component value 0.30 0.27 0.30 0.32
Acoustic
Parameters
pr, α at zMI
(MPa) 2.23E
-02
P (mW) 29.63 29.63
29.6
3
P1×1 (mW) 15.42 15.42
zs (cm) 2.70
zb (cm) 2.50
zMI
(cm) 2.70
zpii, α (cm) 2.70