Terumo Angio-Seal VIP Mode D'emploi page 4

A. Locate the Artery
1. Assess the puncture site location and evaluate the
femoral artery characteristics prior to placing the
Angio-Seal™ device by injecting contrast medium
through the procedure sheath followed by an
angiogram.
2. Using sterile technique, remove the Angio-Seal
device contents from the foil package by opening the
package at the arrow indicator, taking care to pull the
foil seal apart completely before removing the Angio-
Seal device.
NOTE: The Angio-Seal device must be used within
one hour after opening the foil pouch due to the
moisture-sensitive nature of the product.
3. Insert the arteriotomy locator into the Angio-Seal
insertion sheath (Figure 1), making sure the two
pieces snap together securely. To ensure proper
orientation of the arteriotomy locator with the sheath,
the hub of the locator and the sheath cap fit together
only in the correct position. The reference indicator on
the locator hub must align with the reference indicator
on the sheath cap.
Figure 1
Drip Hole
Reference
Indicator
Blood Inlet Hole
Insertion
Sheath Cap
Arteriotomy
Locator
4. Insert the Angio-Seal guidewire into the procedure
sheath that is currently in the patient. If the procedure
sheath is smaller than the Angio-Seal sheath, it
is advisable to ensure that the skin incision is of
sufficient size to accommodate the Angio-Seal
insertion sheath.
5. Remove the procedure sheath, leaving the guidewire
in place to maintain vascular access.
6. Thread the Angio-Seal arteriotomy locator/insertion
sheath assembly over the guidewire; the drip hole
(located above the arteriotomy locator hub) will be
oriented down and away so the flow of blood can be
observed. Make sure the reference indicator on the
insertion sheath is facing up, insert the assembly
into the puncture tract. When the tip of the insertion
sheath is about 1.5 cm into the artery blood will begin
to flow from the drip hole in the locator (Figure 2).
Figure 2
Guidewire
Drip Hole
Insertion
Sheath
Blood Inlet Hole
Tissue
Artery
NOTE: When resistance is encountered at the
anterior vessel wall during over-the-guidewire
advancement of the Angio-Seal locator/insertion
sheath assembly, rotate the assembly 90 degrees
so the reference indicator is facing away from the
user. This places the beveled tip of the insertion
sheath perpendicular to the anterior vessel wall.
TPRARTMT600006632 A_AngioSeal VIP_OUS.indd 2
7. Slowly withdraw the arteriotomy locator/insertion
sheath assembly until blood slows or stops flowing
from the drip hole. This indicates that the distal locator
holes of the Angio-Seal insertion sheath have just
exited the artery (Figure 3).
Figure 3
Blood Inlet Hole
8. From this point, advance the arteriotomy locator/
insertion sheath assembly until blood begins to flow
from the drip hole on the locator.
NOTE: Overinsertion of the arteriotomy locator/
insertion sheath assembly into the artery, beyond
2 cm, may increase the chance of premature
anchor hook up or interfere with the anchor's
performance to achieve hemostasis.
If blood flow does not resume, repeat Steps A-7 and
A-8 until blood flows from the drip hole again upon
advancement of the assembly into the artery.
9. Holding the insertion sheath steady, without moving it
into or out of the artery,
a) remove the arteriotomy locator and guidewire from
Insertion
the insertion sheath by flexing the arteriotomy locator
Sheath
upward at the sheath hub (Figure 4).
1.5 cm
Figure 4
Guidewire
Arteriotomy
Locator
Insertion
Sheath
b) if necessary, rotate the insertion sheath so that
the reference indicator on the insertion sheath cap is
facing up (Figure 5).
Figure 5
Blood
Insertion
Arteriotomy
Sheath
Locator
WARNING: Under normal conditions, the Angio-
Seal insertion sheath should not move into or out
of the artery for the remainder of the Angio-Seal
device deployment procedure. Using the sheath
markings as a guide, ensure that the sheath
position has not changed. If re-advancement is
necessary, the guidewire and puncture locator
must be inserted prior to advancing the Angio-
Seal insertion sheath.
Guidewire
Drip Hole
Little or
No Blood
Arteriotomy
Locator
Insertion
Sheath
Tissue
Artery
Patient
2
B. Set the Anchor
1. Confirm that the device sleeve has remained in the
rear holding position (Figure 6). Carefully grasp the
Angio-Seal device at the bypass tube. Cradle the
Angio-Seal carrier tube in the palm of the hand and,
with the reference indicator facing up, slowly insert the
bypass tube and carrier tube into the insertion sheath
hemostatic valve (Figure 7).
Figure 6
Ensure tab is in rear
holding position prior
to insertion
Figure 7
Reference
Indicator
Carrier
Ensure tab is in rear
Tube
holding position prior
to insertion
Bypass
Tube
Hemostatic
Valve
2. Confirm that the reference indicator on the insertion
sheath is facing up. To ensure proper orientation of
the Angio-Seal device with the sheath, the sheath
cap and the device sleeve only fit together in the
correct position. The reference indicator on the device
cap should align with the reference indicator on the
insertion sheath cap (Figure 8). Keeping the insertion
sheath in place, carefully advance the Angio-Seal
device in small increments until completely inserted
into the insertion sheath. The sheath cap and the
device sleeve will snap together when properly fitted.
Figure 8
NOTE: If significant resistance to carrier tube
advancement is encountered when insertion is
almost complete, the anchor may be impinging
on the posterior wall of the artery. DO NOT
CONTINUE TO ATTEMPT TO ADVANCE. In this
case, slight repositioning of the sheath, either by
reducing the angle of the sheath with respect to
the skin surface or by pulling the sheath back by
1-2 mm, may permit normal deployment.
3. With one hand continue to hold the insertion sheath
cap steady to prevent movement of the sheath into
or out of the artery. With the other hand, grasp the
device cap and slowly and carefully pull back. Slight
resistance will be felt when the device cap is pulled
out from rear holding position. Continue pulling on the
device cap until resistance from the anchor catching
on the distal tip of the insertion sheath is felt.
4. To ensure the correct anchor position, confirm that the
edge of the device cap falls within the colored bands
on the device sleeve.
11/29/2018 10:43:24 AM