Merit medical Preludesync EVO User Manual

REFERENCE GUIDE

PLACEMENT AND INFLATION

• Radial artery use: Ensure the CURVED section of the clear plate is on the THUMB side of the wrist.

• Ulnar artery use: Ensure the CURVED section of the clear plate is on the LITTLE FINGER (fth digit) side of the wrist.

Step 1. Aspirate the sheath, then withdraw approximately one inch (2–3 cm).

Place the center of the “crosshairs” over the arteriotomy (location where the sheath

entered the artery, approximately 1–2 mm proximal to the skin puncture site).
Fasten the band securely around the wrist without any slack. Do not overtighten.

Step 2. Fill the EVO syringe with 20 mL of air. Attach and completely engage

to the valve/ tubing line labeled “AIR” by inserting the syringe tip into valve and
rotating ¼ turn clockwise.

Step 3. Slowly inate the balloon with air while simultaneously removing the

sheath. Once the sheath is removed, continue to inject air into the balloon until

bleeding has stopped. Maintain pressure on the syringe plunger to avoid any
inadvertent release of air while inating.

Step 4. Slowly withdraw air until there is oozing from the access site. Once oozing

is observed, re-inject up to 4 mLs of air into the balloon until hemostasis is achieved.

Additional air may be injected as needed to achieve patent hemostasis. Remove syringe.

NOTE: If bleeding is observed at any time, injec t additional air (do not exceed the max ll volume of 30mL) until
bleeding stops and patent hemostasis is achieved.

NOTE: Air volume and compression time may differ according to patient’s condition, anticoagulant dosage,
and size of puncture site.

Step 1

Step 2

Curved Section

DEFLATION AND REMOVAL

Step 1. At the recommended device removal time, or in accordance with hospital

protocol, withdraw approximately 2 mL of air from the balloon and observe the

access site for bleeding.

NOTE: Maintain pressure on the syringe plunger to avoid any inadvertent release of air when attaching to the device.

NOTE: If PreludeSYNC EVO syringe is not available during air removal or re-injec tion, the cap on tubing line may be removed
by twisting and a standard luer syringe can be attached. CAUTION: DO NOT remove cap while sheath is still in patient.

Step 2. If bleeding is present, inject air until bleeding stops and patent hemostasis is

achieved. Wait approximately 30 minutes and repeat step 1 above, or follow normal

hospital protocol.

Step 3. If no bleeding is present, continue to remove approximately 2 mL of air

every 15 minutes x3, or until pressure is fully released.

Step 4. Once the air is removed and hemostasis is conrmed, carefully remove the

EVO. Place a sterile dressing over site per hospital protocol. Dispose of the EVO
according to hospital protocol

Before using refer to Instructions for Use for indications, contraindications, warnings, precautions, and directions for use.

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