1.
Introduction
1.1
Features
The probe of Model EUP‐VV531 is a convex array type.
The acoustic output of this probe when connected to ultrasound scanner was measured
according to the IEC 60601‐2‐37 standard. The table of measured acoustic output data is
contained in the operation manual of each ultrasound scanner.
This probe is categorized in class IIa according to Directive 93/42/EEC.
According to IEC 60601‐1 the probe is classified as type BF.
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 Transvaginal Probe EUP‐VV531 is designed for observation and diagnosis mainly of
the following regions by connecting with the HITACHI ultrasound scanner.
Transvaginal
Transrectal
1.4
Composition
The probe components of the EUP‐VV531 are as follows:
1) Probe EUP‐VV531 ∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1 piece
2) Instruction Manual∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙∙ 1 copy
Disinfection has not been made to the probe shipped from the factory. Prior to use of it,
be sure to clean and disinfect it.
CAUTION
‐1‐
Q1E‐EP1028