6
Chapter 1
January 2015
bk3000 User Guide
(16-01249-EN-01)
The system displays correct numerical values associated with the diagnosis to be
performed.
The As Low As Reasonably Practicable (ALARP) principle is used and safety
related indications (MI, TIS, TIB, etc) are displayed as worst-case values.
The system does not generate unintended or excessive ultrasound output or
transducer surface temperature.
There is no unintended or uncontrolled motion of transducer assemblies intended for
intra-corporeal use.
Intended Use
The system is intended for diagnostic ultrasound imaging or fluid flow analysis of
the human body, data processing and guidance of puncture and biopsy.
The system performs simple geometric measurements and calculations in the
following areas:
•
Urology
•
Vascular
•
Cardiology
•
OB/GYN
Modes of Operation
•
B-Mode (including Tissue Harmonic imaging)
•
M-Mode
•
PWD Mode
•
CFM Mode
•
Power Doppler
•
Contrast Imaging
1
•
CW Doppler
2
•
Elastography
3
1. In the USA, contrast-enhanced ultrasound has not been market cleared by the FDA, with the
exception of select cardiac imaging applications.
2. CW Doppler on the bk3000 has not been market cleared by the FDA or licensed by Health
Canada.
3. Elastography on the bk3000 has not been market cleared by the FDA or licensed by Health
Canada.
