Table of Contents
1.
General
1.1
General
The EUP-C516 is a convex array probe.
The acoustic output of the EUP-C516 was measured according to the
IEC60601-2-37 standard and the measurement was conducted by
operating with the Hitachi ultrasound diagnostic scanner.
The measured acoustic output is listed in the instruction manual
of the Hitachi ultrasound diagnostic scanner.
The EUP-C516 is categorized in class IIa according to Directive
93/42/EEC and classified as type BF according to IEC60601-1.
1.2
Principles of operation
This probe and the ultrasound diagnostic scanner enable image
diagnosis using ultrasonic waves. This system operates under the
principles described below.
1)
When an electric pulse signal is applied from the transmitter
to the transducer of the probe, the transducer converts electric
signals into mechanical vibration energy for emitting
pulse-shaped ultrasonic waves into the body part, liquid or
other medium contacting the transducer.
2)
The emitted ultrasonic waves are reflected by boundaries with
different acoustic characteristics (acoustic impedance)
within the body.
3)
The transducer is also used to receive reflected ultrasonic
waves. The transducer vibrates mechanically due to the received
ultrasonic waves and converts mechanical vibrations into
electric energy. Electric signals are converted to shades of
brightness by brightness modulation to obtain an image.
1.3
Intended Use
The EUP-C516 is designed for observation and diagnosis mainly of
the following regions by connecting with the Hitachi ultrasound
scanner.
General abdominal organs
General OB/GYN organs
Biopsy (with Biopsy Attachment)
Never use the probe for following applications.
Direct contact to the heart.
Biopsy to the heart.
WARNING
-1-
Q1E-EP0386
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