Step 3b
Performance Testing
All performance requirements for your system according to the KBV guidelines February 1993 are tested.
These guidelines distinguish more than 30 different medical applications of diagnostic ultrasound equipment. For each of these cases performance requirements are quoted. For reimbursement of the diagnostic examination done by a physician in Germany by the public health insurance (KBV) the ultrasound systems used have to meet these requirements. The guidelines distinguish different system types for different medical applications:
System types:
A-mode-system incl. transient time measurement devices. (3.1)
B-mode-system (3.2)
m-mode system (time-motion) (3.3)
cw-Doppler and pw-Doppler with detection of flow direction (3.4)
duplex- systems (pw-Doppler simultaneously with B-mode) (3.5)
spectral analysis of time dependent Doppler signals (3.6)
colour Doppler Imaging combined with B-mode (3.7)
Possible Performance criteria are:
the evaluation of overall sensitivity,
dynamic range,
monitor frame rate, signal/display delay,
display resolution (see KBV-regulation act for details)
and others ...
The results are compiled in a test report including a form with the values accepted by the KBV. If certain criteria are not met further consultation for possible changes in the system to meet these criteria can be done. The amount of work needed for testing and the cost can be calculated with the test plan.
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