User's Manual

2. General Description
User Manual of Mars1717X
21
User Manual of Mars1717X 21
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic
diagnosis for human anatomy including both adult and pediatric patients, but not intended for
mammography or dental applications. The remaining notes depend on the DR system.
PATIENT population:
Age: Adult and pediatric patients
Weight: not relevant
Health: not relevant
Nationality: multiple
Gender: except for pregnant women
PediatricUse:Guidance&Considerations
Special care should be exercised when imaging patients outside the typical adult size range, especially
smaller pediatric patients whose size does not overlap the adult size range (e.g.less than 50 kg (110 lb)
in weight and 150 cm (59 in) in height, measurements which approximately correspond to that of an
average 12 year old.
The following ranges of pediatric subpopulations are to be used as a guide for manufacturers in
developing medical devices:
Pediatric Subgroup Approximate Age Range
Newborn (Neonate) From birth to 1 month of age
Infant Greater than 1 month to 2 years of age
Child Greater than 2 to 12 years of age
Adolescent Greater than 12 through 21 years of age
Exposure to ionizing radiation is of particular concern in pediatric patients because:
1) for certain organs and tumor types, younger patients are more radiosensitive than
adults (the cancer risk per unit dose of ionizing radiation is higher for younger patients);
2) use of equipment and exposure settings designed for adults of average size can
result in excessive and unnecessary radiation exposure of smaller patients;
3) younger patients have a longer expected lifetime putting them at higher risk of
cancer from the effects of radiation exposure.
To help reduce the risk of excessive radiation exposure, you should follow the ALARA (As Low As
Reasonably Achievable) principle and seek to reduce radiation dose to only the amount necessary to