ProStar XL Manual Del Usuario página 5

3 . Grab the anterior suture ends (one white and one green)
adjacent to the topside of the sheath and pull the suture
ends through the distal end of the barrel . Place this pair
of suture ends toward the patient's head .
4 . Grab the posterior suture ends (one white and one
green) adjacent to the underside of the sheath and pull
the suture ends through the distal end of the barrel .
Ensure that this pair of suture ends comes under the
device and towards you . Place this pair of suture ends
toward the patient's feet .
5 . Identify the two ends of a single suture by color, and
then tension the ends using a gentle seesawing motion .
6 . Continue to withdraw the Prostar XL device until the
guide wire exit port exits the skin line . Reinsert a
0 .038" (0 .97 mm) (or smaller) guide wire into the visible
guide wire exit port so that guide wire access can be
maintained until hemostasis is verified . If a guide wire
straightener is used to reinsert the guide wire, care
must be taken to avoid disturbing the hemostasis valve
located in the device just distal to the guide wire exit
port .
Access sites larger than 10F require the use of the "pre-
close" technique .
7 . When utilizing a "pre-close" technique, the Prostar
XL device is exchanged for an appropriately sized
introducer sheath or an additional Prostar XL device if
additional sutures are to be placed around the same
access site .
• Sliding, self-locking surgical knots should be tied
prior to introducer sheath removal according to
the Knot Advancement section below .
Access sites larger than 10F may require the use of an
additional Prostar XL device .
8 . Use of an additional Prostar XL device:
8 .1 If additional sutures are to be placed, position an
additional Prostar XL device rotated 45 degrees
relative to the first Prostar XL device to establish
alternating suture positions and repeat all the steps
above beginning at Prostar XL Device Placement .
8 .2 Identify and secure the sutures from the first
device separately from the sutures of the
additional device .
Knot advancement
1 . Identify the green suture ends . Place one green suture
end in each hand .
2 . Gently tension the suture to create a longer suture end .
(The short end will be your rail limb of suture, for the
green knot) .
3 . Tie a sliding, self-locking surgical knot using the green
suture .
4 . Lay the green suture aside .
5 . Identify the white suture ends . Place one white suture
end in each hand .
6 . Gently tension the suture to create a longer suture end .
The short end will be your rail limb of suture, for the
white knot .
7 . Tie a sliding, self-locking surgical knot using the white
suture .
8 . Securely wrap the white rail suture around your left
index finger . Saturate the suture with saline . Gently pull
on the white rail suture first, keeping the suture coaxial
to the tissue tract . Completely remove the Prostar XL
device from the artery, leaving the guide wire in the
artery .
note: If using the "pre-close" technique, sutures should
be gradually tightened as the introducer sheath is
removed to maintain hemostasis .
8 .1 Do not compress the femoral access site while
withdrawing the Prostar XL device from the tissue
RELEASED
9 .
10 . With the rail suture limb securely wrapped around the
11 .
12 .
13 .
14 .
15 .
16 .
17 .
18 .
19 . Load the white rail suture into the Knot Pusher and
20 . With the rail suture limb securely wrapped around
21 .
22 . Remove the Knot Pusher from the tissue tract and from
23 . Repeat these same steps 18–22 with the green suture .
24 . If hemostasis is not complete, repeat the single-handed
25 . Once hemostasis is achieved, trim the sutures below
5
tract . Applying excessive force to the Prostar XL
sheath, due to site compression, during removal
of the device may result in a needle guide
break . Please refer to neeDLe GuIDe BreAK
ProceDure section for further instruction .
8 .2 Do not tighten the suture around the Prostar XL
sheath . Tightening the suture around the Prostar
XL sheath during device removal may result in
a needle guide break . Please refer to neeDLe
GuIDe BreAK ProceDure section for further
instructions .
Saturate the sutures with saline . Load the rail suture
into the Knot Pusher and continue to advance the knot
forward to the arteriotomy (see figure 6) .
figure 6
left forefinger, place the Knot Pusher under the left
thumb to assume a single-handed position to complete
knot advancement .
Do not tension the non-rail suture to tighten the knot .
Remove the Knot Pusher from the tissue tract and from
the suture without using the thumb knob .
Lay the white suture down, being sure to separate the
rail and non-rail ends .
Repeat steps 8–13 with the green suture .
Repeat steps 1–14 for second set of sutures if
additional device is used .
If hemostasis has been achieved, remove the guide wire
from the patient . Continue with step 18 .
If hemostasis has not been achieved:
17 .1 . Repeat steps 9–14 .
17 .2 . Exchange the Prostar XL device with an
appropriately sized introducer sheath . Care
should be taken to avoid excessive force if the
reintroduction of another introducer sheath is
required . To avoid resistance, use an introducer
sheath small enough to be introduced without
undue force, but large enough to maintain
hemostasis .
17 .3 . Apply conventional compression therapy .
Once again, securely wrap the white rail suture around
your left index finger .
advance to the level of the arteriotomy .
the left forefinger, place the Knot Pusher under the
left thumb to assume a single-handed position and to
complete knot advancement .
With the Knot Pusher in place, tighten the knot by gently
pulling on the white non-rail suture .
the suture without using the thumb knob .
position for 20 seconds . After 20 seconds gently pull on
the non-rail suture to tighten the knot . (Repeat first with
the white suture and next with the green suture) . Do not
apply excessive pressure to the Knot Pusher or suture .
the skin .