CARDIVA VASCADE MVP Manuel D'utilisation page 16

STEP 1 PART A: Exchange Sheath for VASCADE and Achieve Temporary Haemostasis
Step 1.1: Dip Device Tip in Saline
Briefly dip the device tip in saline up to the White Marker Stripe and quickly remove.
Step 1.2: Insert VASCADE
Step 1.3: Deploy the Disc
IFU 5686 AE, 2024-04
1. With the Disc collapsed, gently insert
VASCADE into the introducer sheath
hub until Lock is midway into the hub.
Use short strokes to insert the device.
About 0.5-inch (13 mm) of the Lock
should remain exposed.
2. Verify that the Lock is NOT fully
inserted into the sheath.
Deploy the Disc by firmly holding the Silver
Handle and pulling back the Black Actuator
until it locks in place.
NOTE
The Green Segment will be visible. If the
Disc is not correctly deployed, the Black
Actuator will slide back to its original
position and the Green Segment will
disappear. Repeat the step to deploy the
Disc as needed.
CAUTION
Do not soak the VASCADE Catheter
in saline. This may result in Catheter
pull-through during the sleeve
retraction step. Momentarily insert
only the Catheter tip in saline
solution immediately before use to
avoid over-hydration of the patch.
CAUTION
Do not advance VASCADE into the
patient if resistance is felt due to risk
of vascular injury.
CAUTION
Do NOT continue to pull on the Black
Actuator once it is locked in place, as this
may damage the device.
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