Technical Manual: TM20514-10
AmpMC 3-field Series
Revision: 3.0
Date of release: 2019-01-09
7/24
www.vareximaging.com
2.
Product description
Intended use
The device is intended to be used in medical diagnostic applications with restrictions to human
diagnostics. The device is intended to be used as accessory of an X-ray system in a professional
healthcare facility environment. The device is intended to amplify and integrate the output signal of a
SolidStateMC to the AEC-module of an X-ray generator. The limitations of use are specified in §2.8.
The device is not intended to be used in fluoroscopy applications; near active HF Surgical Equipment
or in the RF shielded room of a system for magnetic resonance imaging, where the intensity of
Electromagnetic Disturbances is high.
Use, other than above, is identified as abnormal use.
The device is intended as an internal component of an X-ray system. The intended user is defined as
the S
ERVICE
P
ERSONNEL
of an X-ray system.
Description of the device§§
The purpose of the Automatic Exposure Control (AEC) of an X-ray system is to obtain the correct
image contrast by measuring the radiation quantity striking the film or detector.
To result in a high-quality image, the AEC’s exposure end switch will stop generating X-rays
automatically when the demanded radiation dose on the detector is reached.
Principle of operation
The AmpMC main functions are:
•
The conversion of electrical current from a SolidStateMC to a voltage ramp. The voltage ramp
signal is proportional to the received dose of the SolidStateMC.
•
To receive field-select signals (from operator via console and generator) and use the correct
field of the SolidStateMC as the incoming signal.
A SolidStateMC serves as a measuring device for X-ray radiation with semiconductor components
(photodiodes) as actual sensors. The ionizing effect of X-ray produces a small electrical current in the
photodiodes and this current is lead to an AmpMC.
The AmpMC converts the small current to a voltage signal that is proportional to the X-ray dose rate,
this signal is integrated and presented as a ramp signal to the AEC controller board inside the
generator and therefore represents a value for the image density.
•
There is no signal available for external use about the status of the device.
Classifications
Subject
Classification
Reference
CE
IIB
93/42/EEC
Electrical safety
None
IEC 60601-1
Electromagnetic Compatibility
intended environment
Professional
healthcare facility
environment
IEC 60601-1-2
Mode of operation
Continuous
IEC 60601-1
Ingress protection
IP2X
IEC 60529
Protection
No
IEC 60601-1 table 6
Not intended for use in Oxygen Rich environment.
Not suitable for Sterilization.
