Document No.:
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3.4 Basic principle
This product is a non-invasive bladder scanner. On account of that ultrasonic diagnosis
is a non-invasive examination method, this device first uses the principle and technology of
ultrasonic imaging and obtains 12 images by using the 3D ultrasonic probe. It measures the
bladder volume with the technology of drawing the bladder boundary points and conducting
point integral operation at the same time. The method is as follows. According to the
gradient value of the image, rapidly outline to obtain the boundary data of each section of
the bladder, while obtaining key data of bladder boundary segment points. For the 12
images obtained through bladder scanning according to the bladder boundary segment
points, the curve at the right of the bladder boundary in each image is divided to 5 segments:
L1, L2, L3, L4 and L5. According to the divided segments of the curve, calculate the integral
value of one section in integral values of L1 first. The sum of the area values corresponding
to all points of L1 is the volume value of L1. And then the positive and negative judgment
shall be conducted to the volume value according to key points of L1, L2, L3, L4 and L5.
The volume of the right part of the bladder scanning section is the sum of the volume values
corresponding to L1, L2, L3, L4 and L5. The volume of the left part shall be calculated with
the same method as that of the right part. The volume value of one scanning section is the
sum of the volume values of the right and the left parts. The volume of the whole bladder is
the sum of 3-dimensional volume of 12 scanning sections. The instrument adopts a 3D
mechanical sector-scanning probe to conduct ultrasonic detection and scanning of the
bladder, and then performs complex operation to calculate the bladder volume. The
operating principle of the instrument is as follow: Firstly, the instrument sends pulse signal
to the 3D probe, and transmits ultrasonic wave to the human body through the energy
converter in the probe. The ultrasonic wave generates reflected or scattered wave in the
human body as it passes through tissue planes, and the tissue and organ can be positioned
according to its return time. According to its strength, tissue characteristics can be detected.
Sending such a set of pulses can only capture one piece of information on a plane of the
tissue, i.e., usually one 2D sectional tissue image needs it to be transmitted at least 96 or
128 times (for a 2D ultrasound device), so as to form a section. And then transmitted and
