User's Manual

2. General Description
User Manual of Luna1012X 17
generates an electrical signal in proportion to the light produced by the portion of scintillator layer
in front of the pixel. The signals from the photodiodes are amplified and encoded by additional
electronics positioned behind the sensor array in order to produce an accurate and sensitive digital
representation of the x-ray image.
2.3. Characteristics
⚫ Wireless static flat panel detector
⚫ AED
⚫ 802.11ac
⚫ 16-bit AD
2.4. Intended Use
This equipment provides digital X-ray imaging for diagnosis of disease, injury, or any applicable
health problem of human. The image is obtained as the result of X-ray passing through the human
anatomy and detected by the equipment.
IRay will provide equipment and software support for integration of system. Luna1012X is a 10x12
wireless portable flat panel detector designed for human, especially for baby.
According to the Luna1012X intended use and the result of risk management, identifying and
describing the essential performance as the following:
To get image of dark field, the Luna1012X shall be not influenced to the imaging acquisition.
To keep the data transmission function, the Luna1012X shall be not influenced to the data and
signal transmission
2.5. ESSENTIAL PERFORMANCE
According to the Luna series INTENDED USE and the result of risk management, image acquisition
and data transmission are defined as ESSENTIAL PERFORMANCE.
Getting dark image proves that ESSENTIAL PERFORMANCE does not influence INTENDED USE.
Method for getting dark image in detail refers to section “installation” and “operation”.
2.6. Application Specification