Storage And Handling; Adverse Events - Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual

8. Storage and Handling

8.1. Storage
Store all system components at room temperature and in a clean environment away
from magnets and sources of electromagnetic interference (EMI).
Do not store ViperSlide Lubricant above 25°C (77°F). Do not freeze ViperSlide
Lubricant. Refer to the ViperSlide Lubricant IFU prior to starting the atherectomy
procedure.
8.2. Handling
• All system and Exchangeable Series components are intended to be used in typical
operating room/catheterization laboratory environments.
• Additional 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, handle, cartridge, guide wire, guide wire torquer,
or lubricant as these components are designed for single-use only.
• Do not use the OAD, handle, cartridge, or the guide wire if their sterile package
barriers are compromised or damaged.
• Do not resterilize any component after exposure of the component to body tissue or
body fluids.
• Do not use the OAD, handle, cartridge, or OAS pump if any of them were dropped
onto a hard surface, from a height at or greater than 12 in (30 cm), as these
components may be damaged and may fail to operate properly.
• Do not use any system components after their use-by date.
• Do not use Viperslide Lubricant if it is exposed to temperatures outside the range
indicated on the package labels.

9. Adverse events

Potential adverse events that may occur and/or require intervention include, but are not limited
to:
• Allergic reaction to medication/media/OAD components
• Amputation
• Anemia
• Aneurysm
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