iRay Technology Pluto0001X - General Introduction; Indications for Use

12
Digital Intra-oral X-Ray Imaging System Pluto0001X /Pluto0002X User's Manual
Ensure that the sensor is stored and used in the following
environment:
Temperature
Temperature
variation
Humidity
Barometric
pressure
Barometric
change
Operation 20~90% RH
700~
1060mbar
hour
Storage
10~95% RH
hour
,m0003 naht erom edutitla na ta rosnes eht etarepo ton oD
the system connected with the sensor also can operate at an
altitude less than 3000m.
Do not expose the sensor to a hot and humid environment,
otherwise it may result in product damage
2. General Introduction
2.1 Indications for Use
The Digital Intra-Oral X-Ray Imaging System (Pluto0001X/
medical units. The product is used for dental X-ray examination
and the diagnosis of structural diseases. The product is expected
to be used in hospitals and clinics, operated and used by trained
professionals under the guidance of doctors.
This device is not intended for mammography and
conventional photography applications.
This device is suitable for providing dental radiography
imaging for both adult and pediatric.
According to the expected use of Pluto0001X/Pluto0002X and
the result of risk assessment, the product essential performance
is identified: image acquisition of X-ray sensor and image
process.
This manual contains information about Pluto0001X/
Pluto0002X. All users should read and understand this manual
before using the product. All information in this manual,