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1. Intended Use
1.1
Intended Medical Use
(1) The intended use of this system is to visualize structures, characteristics, and
dynamic processes within the human body using ultrasound and to provide image
information for diagnosis.
(2) This system provides high-quality ultrasound images in all its modes: 4D mode,
2D mode, M mode, CDI (Color Doppler Imaging) mode (blood-flow imaging), and
Doppler mode (blood-flow spectrum).
(3) This system is a general-purpose diagnostic ultrasound imaging system that
conforms to the standard for Real Time Display of Thermal and Mechanical Output
Indices on Diagnostic Ultrasound Equipment (American Institute of Ultrasound in
Medicine (AIUM), 1992). Note that transducers have their own characteristic
applications. For the transducers that can be used with this system and their
applications, refer to subsection 5.6 "List of Available Transducers".
1.2
Intended Patient Information
Age, health condition: Not specified
However, do not use this system if it is judged that the patient will be exposed to hazard
due to the patient's own condition.
1.3
User Profile
Only physicians or legally qualified persons who have received appropriate training
Before using this system, it must be ensured that the user has received sufficient
training.
1.4
Operating Principles
This system transmits ultrasound signals into the human body from a transducer and
receives the reflected echoes from the human body using the same transducer. It then
processes the received signals and displays them as images on a display screen (LCD
monitor).
Gating signals are sent from the scan control circuit through the transmission delay
circuit and are input to the reception circuit. The reception circuit then generates the
transmission signals (electrical pulses) according to the gating signals.
These electrical pulses are applied to piezoelectric elements that convert the electrical
signals into mechanical vibrations in the transducer. These mechanical vibrations,
which are ultrasound signals, are then transmitted into the human body.
This system supports convex, sector, linear, and some other scanning techniques.
When the ultrasound signals transmitted into the human body encounter a substance
with different acoustic characteristics, they are reflected and return to the transducer as
echoes. Based on the time required for the ultrasound signals to return to the
transducer, the distance between the transducer surface and the reflecting substance
can be determined.
No. 2B771-004EN*M
1-1
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