SIGMA projetor User Manual

Page 48

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MAINTENANCE INSTRUCTIONS

4.17

Annual Maintenance Records

Records of all equipment inspected and maintained during the annual maintenance must be recorded.
Records should indicate:

• the date of the inspection and maintenance.

• name of the qualified individual performing the required inspections.

• problems found and maintenance or repairs performed.

• model number and serial number of the exposure device.

• associated equipment that was inspected and maintained.

• part numbers and associated lot numbers or serial numbers of replacement parts installed.


Model 880 Series Safety Class A Components

Safety Class A Designation Items

Items that comprise the Model 880 Series 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 Series exposure devices and associated equipment must recognize their
responsibilities of maintaining the integrity of the Type B(U)-96 (or Type A) 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 its 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.

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