6
b) if necessary, rotate the insertion sheath so that the reference indicator (arrow) on the insertion sheath cap is facing up (Figure 5).
Figure 5
Insertion
Sheath
Patient
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.
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 just behind the bypass tube with the reference indicator on
the handle facing up. Slowly insert the bypass 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
Tube
Ensure tab is in rear 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 handle 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 the 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.
