General; Principles Of Operation; Intended Use - Hitachi C22K Instruction Manual

1. General

1.1 General
C22K Probe is a Convex Array Probe.
The acoustic output of this probe when connected to ultrasound scanner
was measured according to 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) Never use the probe for following applications.

Direct contact to the heart.

Biopsy to the heart.

Direct contact to the eye
2) Never use the probe with (HF) surgical equipment.

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
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

C22K Probe is designed for observation and diagnosis mainly of the
following regions by connecting with the HITACHI ultrasound scanner.

Intraoperative
WARNING
vibration energy
-1-
for emitting pulse-shaped
Q1E-EP1389