CARDIVA VASCADE MVP Manuel D'utilisation page 19

STEP 2: Deploy Collagen
Step 2.1: Unlock the Black Sleeve
Step 2.2: Retract the Black Sleeve to Expose the Collagen
Step 2.3: Wait for Collagen Hydration
IFU 5686 AE, 2024-04
While continuing to apply gentle tension (through the Clip or by maintaining tension on the
Black Actuator), slide the Key into the Lock. The blue segment should no longer be visible.
1. If the Clip is present, apply gentle
upward tension on the Black Actuator
and remove the Clip.
2.
While continuing to apply gentle
tension on the Black Actuator, grasp
the Lock with the other hand, and
apply gentle upward tension on the
Lock toward the Silver Handle. The
Black Sleeve will move freely after
some initial resistance. A second
resistance point may be felt after the
sleeve is moved approximately
1.6 cm (0.6 in).
3. Fully retract the Black Sleeve
proximally to the Silver Handle. This
exposes the Collagen Patch. The
Green Tube is visible.
1. Apply the Clip on the Catheter using minimal tension or apply gentle upward tension
on the Black Actuator to keep the disc up against the intima.
Allow approximately 30 seconds for collagen hydration (patch swell period) before
2.
stripping the collagen.
WARNING
Grip the Lock to retract Black Sleeve. Do
not grip the device distal to the Lock as this
may result in operator injury which could
lead to possible infection.
NOTES
1. If the Black Sleeve does not retract
easily, confirm the blue end of the Key is
fully engaged in the Lock.
2. If the Collagen Patch is removed during
sleeve retraction, continue procedure
by converting to MC (see "Converting to
Manual Compression (MC)").
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