SIGMA 150Ci - Manual (Page 46)

MAINTENANCE INSTRUCTIONS
4.16
Model 880 Delta, Model 880 Sigma and Model 880 Elite safety class A components
Safety Class A designation items
Items that comprise the Model 880 Delta, Sigma or Elite radiographic exposure device and
associated equipment that are critical for safe radiological operation are classified as Class A
items or components. Class A items can be structures, components and systems whose
failure or function could directly result in a condition adversely affecting public health and
safety. This would include extreme conditions such as the loss of primary containment with a
subsequent release of radioactive material and or a loss of shielding creating a substantial
safety hazard. Replacement parts that are sent to you with a safety Class A designation are
clearly marked with lot numbers and contain instructions to maintain traceability.
Considerations of Safety Class A items
Users of the Model 880 Delta, Sigma and Elite exposure device and associated equipment
must recognize their responsibilities of maintaining the integrity of the Type B(U) package
and the control of Safety Class A items and components by:
● maintaining traceability of Class A replacement items or components to a specific
exposure device or an associated component.
● use of manufacturer specified items to maintain the integrity of the exposure
device/transport package according to the certifications. Do not use generic grade
items or components that do not meet original design specifications.
● performance of periodic inspections to verify the Class A items are not excessively worn
from long term use or have been damaged from accidents.
● use and handling of the system consistent with it's design and intended application.
● promptly notifying the manufacturer in the event a Safety Class A item or component
which contains a defect or deviates from the original design specifications. This action
will initiate a formal evaluation of the defect or deviation.