Medtronic Tri-Ad 900SFC Instrucciones De Uso página 18

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
undamaged and unopened. The outer surfaces of the outer pouch are
NONSTERILE and must not be placed in the sterile field.
9.2. Storage
Store the product in its original packaging, including the outer shelf
carton, in a clean, cool, and dry area to protect the product and minimize
the potential for contamination.
The sterility and nonpyrogenicity of the Tri-Ad™ Adams tricuspid ring is
validated to remain unaffected until the Use By date identified on the shelf
carton, provided the pouches are not opened or damaged.
10. Instructions for Use
10.1. Sizing
The Tri-Ad™ Adams tricuspid ring sizers are used to select the proper
Tri-Ad™ Adams tricuspid ring size for repair of the tricuspid valve. Sizers
are reusable; however, they must be cleaned and sterilized by autoclave
(steam) prior to each use.
Proper ring size selection is an important part of valvular annuloplasty to
help restore proper function. Use a Tri-Ad™ Adams tricuspid ring sizer
set (available in models 950 and 951) and annuloplasty handle
(model 752 or 752XL) for size selection.
Handles and sizers are provided NONSTERILE; they must be cleaned
and sterilized prior to use. To attach the handle, gently squeeze the two
square protrusions on either side of the central slot on the handle and
insert it into the sizer or holder.
Warning: Do not use other manufacturers' annuloplasty sizers or sizers
from other Medtronic annuloplasty products to size the Tri-Ad™ Adams
tricuspid ring. Other ring/band sizers may not indicate the appropriate Tri-
Ad™ Adams tricuspid ring size.
10.2. Tricuspid Annulus Sizing
Place an initial suture near the septal-posterior commissure
approximately at the level of the coronary sinus (Figure 2). To determine
the proper Tri-Ad™ ring size, measure both the area of the anterior and
posterior leaflets and the distance between the commissures of the septal
leaflet. Gently extend the posterior and anterior leaflets and cover the
surface with the sizer (Figure 3). The sizer that has a surface area most
closely matching the surface area of the anterior and posterior leaflets
and notch spacing of the intercommissural distance of the septal leaflet
corresponds to the size of the ring that should be selected.
16 Instructions for Use
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