Disassembly After Use - St. Jude Medical Regent Instrucciones De Uso

Sterilization
Sterilize instruments before each use.
CAUTION: Sterilization temperatures must not exceed 138°C/280°F.
NOTE: Higher temperatures or longer sterilization times may be used; however; increasing the sterilization time or
temperature (not to exceed 138°C/280°F) of the stated cycles may reduce instrument life.
Table 4. Sterilization Parameters
Pre-Vac Sterilization
Temperature
Time

Disassembly After Use

Remove the valve holder from the handle. Discard the holder that is supplied with the valve.
Disposal
The instructions for use is recyclable. Dispose of all packaging materials as appropriate. Dispose of accessories per standard
solid biohazard waste procedures.
Limited Warranty
The user must comply with the terms and conditions of this limited warranty in order for this limited warranty to apply.
St. Jude Medical warrants that if the Product does not comply with the written specifications for the Product, then St. Jude
Medical will accept a return of the Product for replacement for so long as the user requires the Product for use in connection
with the sizing or implantation of the St. Jude Medical™ valve or sizer product(s) identified in the instructions for use, subject
to the other terms of this Limited Warranty including:
The Product must be used in accordance with the instructions for its use and maintenance.

The Product must be returned for analysis to:

Abbott
Roseville Distribution Center
Attn: Postmarket Surveillance
2305 Walnut Street
Roseville, MN 55113
The user must inspect the Product upon receipt and regularly thereafter in accordance with the instructions for its use.

If, at any time, the user believes that the Product has any defect or otherwise does not comply with its written
specifications, the user must immediately stop using the Product and must make a report to St. Jude Medical within
fifteen (15) days (contact SJM Customer Service).
 All Product returned to St. Jude Medical becomes the property of St. Jude Medical. St. Jude Medical will determine
whether the returned Product qualifies for warranty coverage.
ST. JUDE MEDICAL DOES NOT WARRANT THE SUITABILITY OF A PRODUCT FOR ANY SPECIFIC PATIENT, SINCE
FITNESS FOR USE IS A MEDICAL DECISION. Since handling, storage, cleaning, and sterilization of this Product as well as
factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond SJM's control directly
134°C/273°F
5 minutes
5