FujiFilm FDR ES DR-ID1270 Operation Manual page 3

Introduction
DR-ID1270 is an X-ray equipment which acquires a general radiograph from the indirect-conversion
flat panel sensor.
Indications for use (for U.S.)
The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display
radiographic images of human anatomy. It is intended for use in general projection radiographic
applications including pediatric and neonatal exams wherever conventional film/screen or CR systems
may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography
applications.
Intended Use (for European Union and other countries.)
The Fujifilm DR-ID1270 provides digital image capture for radiographic examinations. It is intended for
use in general projection radiographic applications wherever conventional screen-film systems or CR
systems may be used. DR-ID1270 is a device that provides images, which diagnostic image process
is not implemented, to image collecting console. It is not designed for mammography, fluoroscope,
tomography or angiography.
Note : The above statements were determined by applicable medical device regulations which vary
throughout the world. These statements are subject to revision when additional clearance or
approval is obtained.
DR-ID1270 consists of flat panel sensors (DR-ID1271SE/DR-ID1272SE/DR-ID1273SE/DR-ID1274SE/
DR-ID1275SE), software for the control cabinet.
DR-ID1271SE, DR-ID1272E, DR-ID1273SE, DR-ID1274SE and DR-ID1275SE :
Wireless communication mode or wired communication mode is available. When used in wireless
communication mode, an access point and battery pack (optional) are required.
Each flat panel sensor complies with IEC 62220-1 (MEDICAL ELECTRICAL EQUIPMENT -
CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - ) as a general X-ray radiography
equipment.
The detector of flat panel sensors features 150 micron pixel pitch, a wide 16-bit dynamic range and
exposure times up to 3.8 seconds.
This Operation Manual includes descriptions of matters necessary when using the DR-ID1270
such as the equipment overview, operation procedures and precautions to observe, as well as daily
inspections and maintenance.
Accompanying documents were originally drafted in the English language.
Installation may only be conducted by authorized service personnel.
DR-ID1270 Operation Manual 897N120821E
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