Medtronic Tri-Ad 900SFC Instrucciones De Uso página 20

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
10.6. Ring Suture Placement
1. Orient the ring assembly on the tricuspid annulus.
2. Pass the sutures through the ring, approximately 2 to 4 mm apart,
entering at the bottom of the ring and exiting on the top of the ring.
The implantation sutures should be placed outside the green
demarcation marker to avoid the internal stiffener.
10.7. Holder/Handle Removal
1. Use the handle to push the ring down onto the valve annulus while
pulling back on the sutures.
2. Remove the ring from the disposable holder by cutting the retention
suture on the holder, identified by the word "CUT" and an arrow
pointing to the cutting guide slot (Figure 5). Dispose of the holder.
Warning: Do not cut the ring fabric while cutting the holder retention
suture.
Warning: The holder must be removed from the ring at the end of
the procedure for proper function. Under no circumstances is the
holder to be left attached to the annuloplasty ring.
3. Tie all knots around the ring securely and trim all excess sutures
(Figure 6).
4. Test valvular competency.
10.8. Accessories
Use one of the Tri-Ad™ Adams tricuspid ring sizer sets to determine the
appropriate device size.
Model 950: sterilization tray, rigid polysulfone sizer set, flexible silicone
sizer set, and 2 standard handles
Model 951: rigid polysulfone sizer set and flexible silicone sizer set
Use only handle models 752 or 752XL to interface with the holder and
polysulfone sizers.
Refer to the Tri-Ad™ Adams tricuspid ring accessories Instructions for
Use for detailed information on accessory use and sterilization.
Warning: Do not use annuloplasty sizers or handles from other
manufacturers or other Medtronic annuloplasty products to size the Tri-
Ad™ Adams tricuspid ring.
10.9. Sterilization
The ring is provided sterile (irradiation) on the holder and must not be
resterilized. Rings that have been damaged or contaminated from patient
contact should not be used.
18 Instructions for Use
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