ConMed CrossFT Manual Del Usuario página 5

ENGLISH/INSTRUCTIONS FOR USE
a. KNOTLESS TECHNIQUE: pass suture limbs through threader eyelet. Pull the threader tab to load the sutures
through the anchor and driver shaft.
i. For the 4.0 mm anchor, a maximum of 2 Hi-Fi
ii. For the 4.75 mm and 5.5 mm anchors, a maximum of 2 Hi-Fi
suture limbs can be loaded. If loading 5 or 6 Hi-Fi
be removed prior to loading suture limbs through the anchor and driver. To remove the blue sliding suture,
uncleat it at the proximal end of the blue handle and pull one end of the suture to remove.
b. Use a clamp to secure all passed suture limbs and set the driver to the side.
c. Select the appropriate size punch or drill bit and tap to create the pilot hole. In hard bone, the drill bit and tap
should be used. Drive instrument so the depth mark is flush with bone.
d. Ensure that anchor is ready to be inserted before removing punch or tap so that the pilot hole is not lost.
Remove punch or tap and immediately insert anchor through portal.
e. Place tip of anchor into pilot hole firmly. While holding pressure on the driver to keep anchor partially seated
in pilot hole, pull each suture individually to appropriate tension and wrap each suture a minimum of one
complete turn on the telescoping cleat. See figure below.
f. Hold the black knob and maintain forward pressure on the driver. Twist the blue handle clockwise so that
the anchor inserts. The telescoping cleats will advance at the same rate that the anchor is inserting, thus
maintaining constant tension on the sutures and tendon.
g. Insert anchor until depth mark on driver shaft is flush with bone.
h. Uncleat all sutures, including the blue sliding #2 suture that wraps on the proximal end of the blue handle.
Remove driver by pulling straight away from anchor.
i. The blue sliding #2 suture can be used as additional fixation or removed.
j. All sutures can be cut.
3. If using the anchor pre-loaded with Hi-Fi
a. PRE-LOADED OR MEDIAL ROW TECHNIQUE: Select the appropriate size punch or drill bit and tap to create
the pilot hole. In hard bone, the drill bit and tap should be used. Drive instrument so the depth mark is flush
with bone.
b. Ensure that anchor is ready to be inserted before removing punch or tap so that the pilot hole is not lost.
Remove punch or tap and immediately insert anchor through portal.
c. Place tip of anchor into pilot hole. Twist blue handle clockwise so that the anchor inserts.
d. Insert anchor until depth mark on the driver shaft is flush with bone.
e. Uncleat all sutures, including the blue sliding #2 suture that wraps on the proximal end of the blue handle.
Remove driver by pulling straight away from anchor.
f. The blue sliding #2 suture can be used as additional fixation or removed.
g. All sutures can be cut.
PACKAGING, LABELING AND STERILIZATION
1. The CrossFT™ Knotless Biocomposite Suture Anchor should only be used if the original packaging and labeling
are intact.
2. If the CrossFT™ Knotless Biocomposite Suture Anchor packaging has been opened or altered, contact your regional
CONMED sales representative, or in the U.S. contact the Customer Service Department.
3. The CrossFT™ Knotless Biocomposite Suture Anchor is supplied sterile and is single-use only. Do not re-
sterilize this device.
Tape limbs or 2 Hi-Fi
®
#2 suture limbs, the preloaded blue sliding suture must
®
Tape or as a medial row standard suture anchor, follow these steps.
®
4
#2 suture limbs can be loaded.
®
Tape limbs, or a maximum of 6 Hi-Fi
®
#2
®
2
STERILIZE