Directions For Use; Reprocessing Requirements - St. Jude Medical Regent Instrucciones De Uso

Components
Each Sizer Set Model 907 includes:
Seven (7) double-ended aortic sizers corresponding to SJM Regent™ Mechanical Heart Valve

sizes 17 mm–29 mm
One (1) valve holder handle (Model 905-HH)

One (1) autoclavable tray with cover

When sterilizing replacement components, use the steam sterilization parameters indicated for the sizer set.
Storage
The non-sterile sizer set may be stored indefinitely.
Precautions
 Instruments must be cleaned and sterilized prior to each use.
 Do not use cracked, deformed, discolored/rusted, or damaged instruments.
 Improper cleaning may result in an immunological or toxic reaction.
 The sterilization temperature must not exceed 138°C (280°F).
 Do not bend flexible instrument handles beyond a 90° angle.
 Do not expose instruments to cleaning or rinse agents that are not compatible with polyphenylsulfone.
 Autoclavable sizer set trays do not provide a sterile barrier. Handle sizer sets in the same manner as
other reusable instruments that require packaging or wrapping during autoclave sterilization.
 All instruments must be sterilized in a tray or container that is permeable to steam.
 Do not touch the valve when bending the holder handle.

Directions for Use

See the instructions for use packaged with the applicable implantable device for detailed sizing, handling, and
implantation instructions.
The sizer set has been designed and tested for repeated use. However, if visual signs of deterioration become apparent,
please contact your customer service representative.

Reprocessing Requirements

St. Jude Medical has validated these reprocessing instructions. If alternate methods are used, it is the user's responsibility to
ensure that their methods provide effective cleaning and disinfection. The cleaning method must remove all visible blood soil
and contamination.
Testing indicates that products described herein may undergo 100 cleaning/disinfection cycles when cleaned using the
specified reprocessing methods. Deviations from the specified methods may result in reduced instrument life or inadequate
cleaning and disinfection.
Reprocess instruments as soon as reasonably possible following use. After each reprocessing cycle inspect instruments for
signs of cracking, crazing, or degradation that may affect function.
1 Devices may not be available in all countries. Please see your local St. Jude Medical representative.
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