Operation Manual

5.4 Guidelines for Pediatric Applications

Prognosys typically conducts radiologists(Government-certified) usability studies that

compare PRORAD detector models to the marketed devices. Participate radiologists have

demonstrated that the images acquired using the PRORAD 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 PRORAD 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 PRORAD 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 PRORAD 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.

 For system operation, AEC must be used carefully, preferably use manual technique

setting, applying lower doses.

 If possible, use high kVp techniques.

Positioning the pediatric patient: Pediatric patients are not as likely as adults to understand

the need to remain still during the procedure. Therefore it makes sense to provide aids to

maintaining stable positioning. It is strongly recommended the use of immobilizing devices