Biological Valve Storage Procedure

Mitroflow Aortic Pericardial Heart Valve
Each Mitroflow Aortic Pericardial Heart Valve is shipped with two temperature indicators. One that monitors cool temperatures and one that monitors warm temperatures. These indicators are placed on the inside of each Mitroflow Aortic Pericardial Heart Valve box. The hospital staff must check each temperature indicator immediately upon receipt of any shipment containing Mitroflow Aortic Pericardial Heart Valve. If either or both of the temperature sensors have been tripped, please contact your local distributor to have the product replaced.

The following images show a "Normal" and "Exposed or Activated" cold and hot temperature indicator. Hospital staff should be familiar with how to read these temperature indicators.

Freeze Watch Indicator		High Temperature Indicator
Normal	Exposed (Activated)	Normal	Exposed (Activated)

Hospital staff must also check each valve jar upon receipt to ensure that the tamper evident seal has not been tampered with or broken. If you receive a jar that has had the tamper evident seal broken or tampered with, please contact your local distributor to have the product replaced.

Mitroflow valves must be stored between 4ºC and 40ºC (39ºF - 104ºF). Avoid locations where extreme temperature fluctuations may occur; i.e. near steam, hot water pipes, air conditioning ducts, direct sunlight, etc. Refrigeration is not required. Although refrigeration at 5°C (41°F) is acceptable, the risk of undetected freezing must be considered. Freezing may seriously damage the valve and render it unfit for use. Do not store under refrigeration unless continuous temperature monitoring is maintained.

Hospital staff should regularly inspect the inventory for damage, poor storage conditions or fluctuations in temperature that might affect the product.

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