User Manual

4.4

Guidelines for Pediatric Applications

InnoCare typically conducts radiologists(Government-certified) usability

studies that compare Yushan detector models to the marketed devices.

Participate radiologists have demonstrated that the images acquired using the

Yushan detectors are deemed to be of diagnostic capability.

Additionally, please review the following scientific literatures regarding

pediatric (https://www.ncbi.nlm.nih.gov/pubmed/29064378) and neonates

(https://www.ncbi.nlm.nih.gov/pubmed/23086629). The verification of Yushan

detectors are using even lower energy or x-ray voltages to acquire the image,

which prove the safety and effectiveness for pediatric and neonates

applications. Please refer to the following paragraphs for detailed explaination.

For pediatric, this study has evaluated the physical image quality

characteristics of five detectors (2 for CR and 3 for FPD) for paediatric

applications, using the IEC RQA5 energy. The results show a clear evolution in

detector performance for both the CR and FPD detectors, with physical image

quality continuing to improve. In this artical, the DQE was evaluated at the

normal operating detector air kerma (DAK) level, defined at 2.5 µGy for all

detectors. The performance of MTF and DQE for Yushan detectors were all

tested and verified at the level of 2.0 µGy, and the test results shows highly

sensitivity for image quality.

For neonates, in this study, they investigated the digital characteristics of the

digital mobile X-ray imaging system equipped with a new FPD for different

tube voltages, and showed that it has an excellent linearity of the digital

characteristics and constant contrast characteristics for tube voltages in the

range of 50-110 kV. The system can be used for significantly reducing the ESD

to neonatal patients (examined by chest X-ray in the NICU) as well as the

X-ray system operator exposure more effectively than is available with

conventional systems. The physical characterization of the Yushan detectors

were obtained with the standard beam conditions RQA5 (in accordance with

IEC 61267:1994) with the x-ray tube voltage 70kV.

Furthermore, please review the following link and reduce pediatric technique

factors accordingly: http://www.imagegently.org

As a general rule, next recommendations shall be observed in pediatrics:

 X-Ray Generator must have short exposures times.