Selenia User Guide
Chapter 2—General Information
MAN-03270 Revision 003 13
2.2 Radiation Safety
2.2.1 Exposure Duration
Table 1: Factors That Limit Exposure Duration
Timer
• Release of the X-ray button before the exposure
ends.
• Exposure longer than the preset "back-up time"
• The independent safety hardware back-up timer.
• Detection of a generator fault
2.2.2 Operator Radiation Shield
The radiation shield meets the requirements of 21CFR 1020 and IEC 60601-2-45.2001. The
shield has a rating of a 0.5 mm Pb (lead) equivalent and is permanently installed.
Caution:
Use care when cleaning the X-
ray Shield to avoid excessive
force and movement of the shield.
Note
Verify the shield integrity every day before use.
2.2.3 Patient Face Shield
The Patient Face Shield keeps the face of the patient out of the radiation field.
2.2.4 Exam Room Door Indicators
• The system provides for an external Power-On indicator.
• The system provides for an external X-ray Exposure In Progress indicator.
2.3 Mechanical Safety
The equipment meets the requirements of IEC 60601-1, UL 60601, and CSA 22.2 No. 601.1
by these safety features:
• The C-arm rotation braking is ensured upon loss of power.
• Compression release is disabled when a localization paddle is installed.
• Motorized compression force has a limit of 200 N (45 lb).
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