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2.10 DETERMINISTIC EFFECTS
2.11 PRODUCT COMPLAINTS
0232F EN 20191213
Deterministic effects may occur when the Radiation dose to a certain organ or
tissue exceeds a specific threshold. Particular organs or tissues of such
concern in diagnostic Radiology are the skin and the eye lens. The numerical
value of the threshold dose is in the range between 1 Gy and 3 Gy.
As shown in the Quantitative Information Tables, the radiation dose effects
measured in this equipment are below the threshold in which the severity of
certain effects would take place on human skin or eyes lens.
This mentioned threshold was established by the International Commission on
Radiological Protection (IRCP Publication No 60).
Quantitative Information tables (Refer to Section 2.9) illustrate examples of
available loading factors for image performance and supply Dose indication,
which affect to the radiation quality or to the radiation dose rate applied in normal
use.
As indicated in the Quantitative Information Tables, the number of exposures
needed to reach the previously described maximum radiation values will
depend on the selected techniques for each radiographic study.
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify Agfa.
If the device malfunctions and may have caused or contributed to a serious
injury of a patient, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094
DX-D 400
User Manual
45
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