CEFLA NewTom 5G, User Manual, Page: 30 / 110

4 Getting started
WARNING:
In prescribing radiographic examinations of pregnant or
possibly pregnant women, full consideration should be taken of
the consequences of fetal irradiation. Irradiation of a fetus
should be avoided whenever possible.
WARNING:
This device is particularly designed for use on patients more
than approximately 11 kg (24 lb) in weight and 87 cm (34.25 in)
in height; these height and weight measurements
approximately correspond to that of an average 3 year old.
Studies have shown that pediatric patients may be more
radiosensitive than adults (i.e., the cancer risk per unit dose of
ionizing radiation is higher), and so unnecessary radiation
exposure is of particular concern for pediatric patients.
4.1.3
Improper Use
The NewTom 5G device has not been designed for the following uses and/or applications (reasonably
foreseeable improper use):
–
use with patients that cannot stand still during the entire scanning cycle (30 seconds max.);
–
use in anatomic regions that are not within the scope of the device intended use (e.g., chest and
abdomen);
–
use for studying cerebral soft tissues;
–
use by staff that have not received training on the device;
–
use by staff that do not meet the requirements specified in the user profile;
–
use in the operating theatre;
–
use with removable metal objects (eye glasses, jewels, rings, necklaces) in the scanning field;
–
use in environmental conditions other than the indicated ones.
4-2 NewTom 5G – User Manual