1. Safety Information
PATIENT population:
Adult and pediatric patients
Weight: not relevant
Health: not relevant
Nationality: multiple
Patient state: patient is not user
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 obtain images that are adequate clinically.
Additional guidance and recommendation are provided by the Alliance for Radiation
User Manual of Mars1417X 25
