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English
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Do not alter the usual practice of pre-, peri-, or post-operative
administration of anticoagulation therapy, which could increase the risk
of adverse events associated with this therapy.
Misuse of this suture prosthesis, like any other suture, can result in severe
injury or death to the patient. As with any suture, care should be taken to
avoid damage when handling. Avoid crushing or crimping the suture with
surgical instruments or exposing the suture to sharp edges, which may
adversely affect the tensile strength of the suture. Avoid using knot pushers
with imperfections such as burrs or flashing which may damage the suture.
Avoid untying the pre-tied suture knots on each pre-measured loop.
At least seven (7), equally tensioned, flat square throws are required to
produce a secure knot when tying the Chord-X
™
Pre-Measured Loops or
the Chord-X
™
Suture System for Mitral Chordal Replacement made of
ePTFE suture. Additional throws may be necessary depending on surgical
circumstances. When tying knots with the Chord-X
™
Pre-Measured Loops
or the Chord-X
™
Suture System prostheses made of ePTFE suture, tension
should be applied by pulling each strand of the suture in opposite directions
with equal force. As the knot is tensioned, the air in the suture is forced out.
Care should be taken to avoid using a jerking motion which could break the
suture. Uneven tensioning of a well-formed square knot may result in an
unsecure knot. When the Chord-X
™
Pre-Measured Loops or the Chord-X
™
Suture System for Mitral Chordal Replacement is properly tensioned and
formed, standard surgical knotting techniques will produce a secure knot.
The Chord-X
™
Pre-Measured Loops and the Chord-X
™
Suture System
prostheses are designed for single use only; do not reuse device. On-X Life
Technologies, Inc. does not have data regarding reuse of this device.
Reuse may cause device failure or procedural complications including device
damage, compromised device biocompatibility, and device contamination.
Содержание Chord-X Series
Страница 2: ......
Страница 73: ...73 1 74 2 74 3 75 4 75 5 75 6 76 6 1 76 6 2 Chord X 76 6 3 77 6 4 77 6 5 77 6 6 78 6 7 79 7 79 8 80 9 80 81...
Страница 75: ...75 3 4 ePTFE PTFE Chord X Chord X ePTFE Chord X Chord X 5...
Страница 77: ...77 2 3 3 4 PTFE 6 3 Chord X Chord X 1 Chord X 3 2 Chord X 4 6 4 Chord X Chord X 5 6 5 1 Chord X Chord X...
Страница 78: ...78 Chord X Chord X Chord X 6 2 Chord X Chord X 7 Chord X Chord X Chord X 6 6 8...
Страница 84: ...Figures 84 Figure 5 Papillary suture placement 2 1 3...
Страница 86: ...Figures 86 Figure 8 Final Chordal Replacement...
Страница 87: ......