User's Manual Part 1

PART I. User & Installation Manual
24 1417WGC/WCC
1.6 Label and Location of Attachment
Refer to the back of the device for details.
1.7 Summary of usability specifications
Medical purposes
 Provision and reading of disease and injury diagnostic images
Patient groups
 No patient population exists who uses or is in contact with the device.
 Patient population for the X-ray images read is not specified.
Parts of body or organizations to which the device is mounted or that interact
with the device
 Detector contacts the body surface of a patient and an operator.
Significant physical and performance characteristics
 Refer to 2.4 Part Specifications in this manual
Operating principles
 Flat panel detector is a system that can acquire, save, process and transfer digital images
of an area of interest taken with X-ray. X-ray beam entering the X-ray imaging sensor is
converted into visible light by scintillation layer of the sensor. The amorphous silicon (a-Si)
and Photo Diode on TFT Array of the sensor further converts visible light into electric signal.
Electric signals are amplified and converted to digital signals to form image data.
Obtained image data is transferred to the computer via Ethernet or Wi-Fi interface and
visually displayed on the monitor screen.
Intended user profile
 No special training is required to use this device. The intended users of this device are as
follows.
A professional in good health with specialist knowledge/ qualifications who has fully understood
the content of this document. (Such as a doctor or radiological technologist)