InspireMD MGUARD Prime Instrucciones De Uso página 4

7. Directions for use
Caution: If any resistance is felt during lesion crossing or if the
system is unable to cross the lesion easily, do not attempt to pull
the stent system back through the guiding catheter: dislodgement
of the stent can occur. Pull back carefully the entire system (guiding
catheter, guide wire and stent delivery system) as a single unit.
The lesion then must be predilated or otherwise prepared via an
alternative strategy, if intention for stenting is maintained. Do not
use the same stent system after predilatation because the stent
and/or the stent delivery system may have been damaged during
the first attempt to cross the lesion or during withdrawal.
Caution: Special care must be taken not to handle or in any way
disrupt the stent position on the delivery system. This is most
important during catheter removal from packaging, removing the
protective cap, placement over guide wire, and advancement
through rotating haemostatic valve adapter and guiding catheter
hub. Manipulation, e.g., rolling the mounted stent, may cause
dislodgement of the stent from the delivery balloon.
7.1. Stent Delivery System Preparation
1. Using sterile technique, remove the SDS and dispenser from
the package and place it onto the sterile field.
2. Gently pull out the catheter from the dispenser.
3. Carefully remove the protective cap.
4. Visually check the stent crimping for uniformity, no protruding
struts and centering on the balloon.
Visually check the sleeve for uniformity, no run outs and centering
on the stent. Do not use the device if any defect is noted.
7.2. Flushing of Guide-Wire Lumen
1. Using flushing needle, connect a syringe containing sterile
saline solution to the distal tip of the catheter and flush the
guide wire lumen.
2. Remove the syringe.
3. Avoid manipulation of the stent during removal from packaging
and flushing of guide wire lumen.
4. Do not pre-inflate the balloon prior to stent deployment. Use
balloon purging technique described further.
Caution: Do not apply negative pressure to the catheter prior to
placement of the stent across the lesion. This may cause premature
dislodgement of the stent.
7.3. Insertion
1. Visually inspect the stent placement prior to insertion through
the hemostatic valve.
2. Attach haemostatic valve to the Luer lock connector of the
guiding catheter positioned within the vasculature.
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3. In case the coronary guide wire has not already been
positioned across the lesion, under fluoroscopy insert a 0.014"
(0.36 mm) guide wire across the lesion, following standard
PTCA techniques.
4. Insert proximal end of the guide wire into the distal tip of the
catheter.
5. Carefully insert SDS through the haemostatic valve and
advance the catheter.
Caution: Make sure that the haemostatic valve is completely open
before inserting the delivery system, since a partially open valve
might damage the stent or dislodge it from the centered location
on the dilation balloon.
6. Under fluoroscopic guidance, carefully advance the stent and
SDS through the guiding catheter and into the coronary artery
following the guide wire towards the target lesion.
7. Position the stent within the lesion using the radiopaque
markers located on the balloon catheter as reference points
for precise placement across the target lesion.
Caution: If any resistance is felt when the catheter is pushed out
of the end of the guiding catheter, be sure to determine the cause.
If you cannot determine and eliminate the cause, then retract the
entire system (guide wire, delivery system and guiding catheter)
together, as a single unit.
7.4. Stent deployment and Balloon removal
1. Maintaining the stent within the lesion, connect a syringe
containing 50:50 mixture by volume of contrast medium and
sterile saline solution to the Luer lock in the proximal hub of the
catheter and apply negative pressure for about 15 seconds until
no bubbles appear in the contrast medium solution. Return the
syringe leaving a meniscus of contrast in the hub of the balloon
lumen.
2. Remove air bubbles from the inflation device following the
manufacturer's instructions.
3. Attach inflation device to the SDS. Avoid allowing air to enter
the system.
4. Inflate the dilation balloon gradually to expand the stent to the
calculated diameter in accordance with the Compliance Chart.
Apply constant pressure for at least 30 seconds.
5. Stent should be expanded to a vessel/stent diameter ratio of
no more than 1:1.5.
Caution
Do not expand the stent if it is not properly positioned in the
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target lesion.
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PAC-0318-V4