Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
9
6. OAS component storage and handling
6.1 Storage
Store all OAS components in a clean environment and away from humidity,
magnets, and sources of electromagnetic interference (EMI). OAS performance
may be affected if any OAS component is exposed to temperatures outside the
range indicated on their individual package labels.
6.2 Handling
Ensure that the OAD, the OAS pump, and the VIPERWIRE guide wire are
within the storage and operating temperature range of 50 – 104° F (10 - 40° C).
If the OAD, the OAS pump, or the VIPERWIRE guide wire are outside
operating temperatures, the OAD, the OAS pump, or the VIPERWIRE guide
wire may not function as intended.
Additional coronary OAS components should be on hand in the event of
damage to any of the components or to component packaging.
Do not reuse or resterilize the OAD, VIPERWIRE guide wire or VIPERSLIDE
Lubricant as these components are designed for single-use only.
Do not use the OAD or the VIPERWIRE guide wire if their sterile package
barriers are compromised or damaged.
Do not use the OAD or OAS pump if either of them were dropped onto a hard
surface, from a height at or greater than 12 in (30 cm), as the OAD or OAS
pump may be damaged and may fail to operate properly.
Do not use any OAS components after their use-by date or if the OAS
components were subjected to temperatures exceeding their safe storage or
handling temperature ranges.