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INSTRUCTIONS FOR USE - MANTA
Step 2: Exchange and Position Sheath
Prior to using the MANTA Closure, the procedure sheath must be exchanged for the MANTA Sheath:
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Flush the Introducer with heparinized saline. Insert the MANTA Introducer into the MANTA Sheath until the hub of the Introducer aligns with the
Sheath hub. Turn the Introducer hub clockwise ¼ turn to lock into the Sheath. (Figures 3 and 4).
Figure 3 – Inserting the MANTA Introducer into the MANTA Sheath
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Remove the large-bore procedure sheath while maintaining vessel access with the guidewire. Utilize digital pressure as needed during this step.
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Advance the assembled MANTA Sheath and MANTA Introducer over the guidewire as far as the patient anatomy will permit.
NOTE: If significant resistance is felt advancing the MANTA Sheath and Introducer into the vessel, this may be indicative of swelling, scar tissue,
calcification, or tortuosity. DO NOT proceed with MANTA Closure as the device may become damaged.
•
Remove the MANTA Introducer from the MANTA Sheath, leaving the guidewire and MANTA Sheath in position. The MANTA Introducer hub must
be rotated ¼ turn counter-clockwise to unlock and remove from the Sheath. The MANTA Sheath is now in position to receive the MANTA Closure
(Figure 5).
Step 3: Insert Device
With the MANTA Sheath in place, the MANTA Closure may now be inserted and deployed:
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Insert the guidewire into the distal guidewire lumen on the MANTA Closure (Figure 6).
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As the guidewire emerges from the back of the MANTA handle and pushes the lumen out of the handle, grasp the lumen and remove from device
and guidewire. Discard the lumen. Continue inserting guidewire through MANTA device.
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Ensure the bypass tube is fully covering and protecting the toggle.
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Holding the bypass tube between thumb and forefinger (Figure 7), while grasping the MANTA Closure by the delivery tube AND bypass tube, insert
the bypass tube gradually into the hemostasis valve and into the MANTA Sheath hub.
NOTE: If significant resistance is felt inserting the bypass tube into the MANTA sheath, remove the entire system and open a new device.
•
Push the bypass tube into the sheath hub and observe that the bypass tube is completely inserted. Note that the device must be upright with
orientation markers visible and facing upward.
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Advance the delivery tube of the MANTA Closure THROUGH the bypass tube and down the MANTA Sheath until the MANTA delivery handle
approaches the sheath hub. Make small advancements to avoid kinking the delivery tube of the MANTA Closure (Figure 8).
NOTE: If the MANTA delivery system becomes kinked during insertion into the sheath, remove the entire system and open a new device.
Figure 7 – Insertion of MANTA Closure - Holding the Bypass Tube
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Align the MANTA delivery handle to the sheath hub (Figure 9) and carefully advance the MANTA Closure until the delivery handle snaps to the
sheath hub where an audible click will be heard. The MANTA Closure is now fully inserted into the MANTA Sheath (Figure 10).
NOTE: DO NOT advance MANTA Closure fully into sheath if significant resistance is felt, indicating that the toggle is meeting resistance in entering
the vessel. Reposition the sheath by slightly retracting the sheath if necessary.
Figure 9 – MANTA Closure Insertion into MANTA Sheath
Step 4: Position Device
Before Deploying the device and releasing the toggle, position the MANTA Closure and Sheath according to the deployment depth noted in 'Step 1:
Arteriotomy Locating Procedure.'
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Grasp the MANTA Delivery handle and slowly withdraw the MANTA Closure and Sheath until the depth marking appears that corresponds to the
deployment depth noted during Step 1. The MANTA Closure is now in deployment position (Figure 11) and ready for toggle release.
NOTE: DO NOT re-advance the MANTA Closure and Sheath deeper into the vessel if they are withdrawn past the deployment depth. If this occurs
prior to rotating the lever, remove the entire system and open a new device.
Step 5: Deploy Device and Seal Puncture
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Hold the MANTA Handle in the right hand at a 45 degree angle to the leg. While grasping the proximal handle end of the MANTA Closure with the
right hand, completely actuate the lever arm in the clockwise/ proximal direction. This deploys and releases the toggle within the vessel (Figure
12).
LBL-001 REV. A
2018/01
AFTER large-bore procedure
Figure 5 – Fully Inserted MANTA Sheath Positioning
Figure 6 – Insertion of Guidewire into MANTA Closure
Figure 11 – Positioning the MANTA Closure and Sheath
Figure 12 – Actuating the Handle Lever and Releasing the Toggle
Figure 4 – The Assembled MANTA Introducer and Sheath
Figure 8 – Advance Delivery Tube and MANTA Closure into MANTA Sheath
Figure 10 – MANTA Closure Device fully inserted into vessel
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