Contraindications; Precautions; Sjm™ Séguin Annuloplasty Ring; Sjm™ Séguin Annuloplasty Ring Sizer Set Model Sar-501 - St.Jude Medical SJM Seguin SARP-24 Mode D'emploi

CONTRAINDICATIONS

Use of the SJM™ Séguin Annuloplasty Ring is contraindicated in cases where
severe organic lesions with retracted chordae tendineae require valvular
replacement and where there are congenital malformations which lack valvular
tissue. Additionally, use of the ring is contraindicated whenever the physician
determines that the remaining functional valve tissue and valve support structures
are not adequate to provide the required hemodynamic performance or structural
strength.
Use of the SJM™ Séguin Annuloplasty Ring is contraindicated for active bacterial
endocarditis.
Use of the SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501 with
products other than the SJM™ Séguin Annuloplasty Ring is contraindicated.
When sterilizing the SAR-501 sizer set, any sterilization method other than steam
is contraindicated.

PRECAUTIONS

SJM™ Séguin Annuloplasty Ring
• Do not use the ring if the "USE BY" date on the packaging has passed.
• Examine the device packaging carefully, and ensure the pouch is
unopened and unbroken. If you note any damage, do not use the device,
and contact St. Jude Medical customer service.
• Remove the identification tag and suture prior to implantation. Avoid
cutting or tearing the ring during removal of the identification tag and
suture.
• Do not place sutures in the circumflex coronary artery or in the right
coronary artery.
• Do not place sutures in the atrial tissue, as this may result in impairment
of the cardiac conduction system.
• Do not attempt to deform or otherwise alter the configuration of the
prosthetic ring to conform to a specific annular anatomy, as this could
damage the ring. If the ring is not suitably sized for the annulus, a larger
or smaller ring should be chosen.
• To avoid damage to the fabric covering the ring, do not use cutting edge
needles, and avoid manipulation with forceps during implantation.
• Remove any loose suture or thread, which may be a source of thrombus
or thromboembolism.
• Prophylactic antibiotic treatment should be considered for all patients
undergoing dental or other potentially bacteremic procedures.
SJM™ Séguin Annuloplasty Ring Sizer Set Model SAR-501
• 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.
• 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 expose sizer set components to cleaning or rinse agents that are
not compatible with polysulfone or polyphenylsulfone.

MAGNETIC RESONANCE (MR) SAFETY

The SJM™ Séguin Annuloplasty Ring is MR safe.
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