On-X Chord-X Series, Инструкция по эксплуатации

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Reuse may result in infection, serious injury, or patient death.
6. RECOMMENDED TECHNIQUES
6.1. Determine the artificial Chord-X
™
Pre-Measured Loops or Chord-X
™
Suture System Adjustable loop length.
Determine the artificial Chord-X
™
Pre-Measured Loops or Chord-X Suture
System adjustable loop length via surgeon preferred technique, to maintain
the coapting surfaces of the two leaflets at the same level in the ventricle.
6.2. Unpack Chord-X
™
Pre-Measured Loops or the Chord-X
™
Suture
System prostheses from the base-plate.
After determining the artificial chordae loop length, choose the appropriate
Chord-X ™ Pre-Measured Loops prosthesis or the Chord-X ™ Suture System.
Open the package using sterile technique. Each prosthesis is positioned on
a series of base-plates for suture management. If fewer chordal sutures are
desired, excess segments can be removed without jeopardizing the rest of
the prosthesis.
1. Remove foam base-plates from case.
2. Unwrap the papillary suture with attached pledget from the baseplate.
3. Unwrap chordal prosthesis sutures 1, 2 and 3 from their respective base-
plates.
4. Remove the additional PTFE pledget from case if desired.
6.3. Removing extra loops.
The Chord-X
™
Pre-Measured Loops prosthesis version and the Chord-X
™
Su-
ture System prosthesis version feature 1 suture pair for a papillary muscle
and 3 independent pre-measured chordal suture loops or 3 suture strands
(for the leaflet) complete with needles. If fewer chordal sutures or strands are
desired, excess segments are easily removed without jeopardizing the rest
of the prosthesis.
1. Removing extra loops from the Chord-X
™
Pre-Measured Loops
prothesis version:
Remove undesired prosthetic loops by cutting a single strand of suture
between the knot and the papillary suture strand and discard.
( See Figure 3 )