Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
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12. OAS Pump Declaration of Conformity
CSI declares that the coronary OAS is in conformity with the requirements of: IEC
60601-1. The OAS pump is compatible for use in a standard catheter laboratory
environment.
13. EMC Declaration
Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC). Install and use medical electrical equipment according to the EMC
information below:
• Do not have portable and/or mobile radio-frequency (RF) communications
equipment within close proximity of medical electrical equipment as portable and
mobile RF communications equipment can affect medical electrical equipment.
• Ensure that power frequency magnetic fields are at levels characteristic of a typical
commercial or hospital environment.