Medtronic Tri-Ad 900SFC Instrucciones De Uso página 19

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
10.3. Handling and Preparation Instructions
1. Open the box and remove the product literature, Patient Registration
Form, and envelopes.
2. Remove the double-aseptic transfer pouch containing the device.
3. Inspect the pouches ensuring they have not been opened or
damaged. The ring assembly is sterile as long as the inner pouch has
not been compromised. If the inner pouch is damaged, do not implant
the device.
4. If the outer pouch is damaged, the exterior surface of the inner pouch
may not be sterile.
5. Open the outer transfer pouch and, while still holding the bottom of
the outer pouch, pass the inner pouch into the sterile field.
6. The inner pouch should be opened only in the sterile field.
10.4. Device Implantation
The Tri-Ad™ Adams tricuspid ring assembly may be used with or without
the handle (model 752 or 752XL, provided separately).
1. Remove the appropriately sized Tri-Ad™ Adams tricuspid ring from
the sterile package using aseptic technique.
2. Remove the serial number identification tag by cutting the retaining
suture and record the serial number in the patient's record. Verify that
the serial number matches the serial number on the Patient
Registration Form.
Warning: The serial tag must be removed from the ring for proper
function. Do not cut or tear the ring fabric during removal of the serial
tag.
3. Align and engage a sterile handle into the snap-fit cavity of the holder.
The handle must be inserted into the side of the holder with the snap-
fit cavity and printed text. The thin section of the handle is malleable
to permit alignment of the ring holder with the annulus.
10.5. Tricuspid Annulus Suture Placement
Place additional interrupted sutures, approximately 4 mm apart,
continuing along the annulus and ending at the midpoint of the anterior
leaflet (Figure 4). Approximately 8 to 10 sutures should be placed in the
valve annulus.
Warning: Do not place sutures in the coronary sinus, right coronary
artery, AV node, bundle of His, or other conduction tissue.
Note: Pledgets may be used with annular sutures to reduce the possibility
of ring dehiscence.
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Instructions for Use English 17