KOSMOS User Guide 99
Biological safety
Measurement accuracy
Measurement accuracy for distance and area in B-mode images are as follows:
• Axial measurement accuracy: Axial distance measurements in 2D imaging
modes shall be accurate to within +/- 2% of the displayed value (or 1 mm,
whichever is larger).
• Lateral distance measurement accuracy: Lateral distance measurements in
2D imaging modes shall be accurate to within +/- 2% of the displayed value
(or 1 mm, whichever is larger).
• Diagonal measurement accuracy: Diagonal distance measurements in 2D
imaging modes shall be accurate to within +/- 2% of the displayed value (or 1
mm, whichever is larger).
• Area measurement accuracy: Area measurement accuracy in 2D imaging
modes shall be +/-4% of the nominal value.
Measurement accuracy for distance and time in M-mode images are as follows:
• M-mode distance measurement: M-mode distance measurements shall be
accurate to within +/- 3% of the displayed value.
• M-mode time measurement accuracy: M-mode time measurements shall be
accurate to within +/- 2% of the displayed value.
Control effects
KOSMOS does not provide the user with direct control of acoustic output power.
KOSMOS has been designed to automatically adjust the output to ensure that
acoustic limits are not exceeded in any imaging mode. Since there is no direct
user control for output, the user should rely on controlling exposure time and
scanning technique to implement the ALARA principle.
Related references
• U.S. Dept. of Health and Human Services, Food and Drug Administration,
Guidance for Industry and FDA Staff - Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers (2019)
• IEC 60601-2-37:2015 Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic
medical diagnostic and monitoring equipment
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