How Supplied; Operational Instructions - Stryker Neuroform Atlas Instrucciones De Uso

MaGnetIC resonanCe IMaGInG (MrI) saFetY InForMatIon
Magnetic resonance Conditional
Non-clinical testing and analysis have demonstrated that Neuroform Atlas™ Stent
is MR Conditional alone, or when overlapped with a second stent, and adjacent to
a Stryker Neurovascular coil mass. A patient with Neuroform Atlas Stent can be
safely scanned immediately after placement of this implant, under the following
conditions:
• Static magnetic field of 1.5 and 3.0 Tesla
• Maximum spatial gradient field up to 2500 Gauss/cm (25 Tesla/m)
• Maximum MR system reported whole body averaged specific absorption rate
of 2 W/kg (Normal Operating Mode) and head averaged specific absorption
rate of 3.2 W/kg.
Under the scan conditions defined above, the Neuroform Atlas Stent is expected
to produce a maximum temperature rise of 4°C after 15 minutes of continuous
scanning. The Neuroform Atlas Stent should not migrate in this MRI environment.
In non-clinical testing, the image artifact caused by the device extends
approximately 2 mm from the Neuroform Atlas Stent when imaged with a spin
echo pulse sequence and a 3 Tesla MRI System. The artifact may obscure the
device lumen. It may be necessary to optimize MR imaging parameters for the
presence of this implant.

How sUppLIeD

Stryker Neurovascular products are sterile and non-pyrogenic in unopened
packaging that is designed to maintain sterility unless the primary product pouch
has been opened or damaged.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and storage
Store in a cool, dry, dark place.

operatIonaL InstrUCtIons

Initial access, angiographic assessment and stent selection
1. Gain vascular access according to standard practice. Select a recommended
microcatheter (see Required Accessories section on Page 2). Establish
and maintain continuous flow of appropriate flush solution through the
microcatheter per standard vascular practice. Using angiography, determine
the location of the aneurysm and the size of the aneurysm neck.
2. Navigate the microcatheter over an access length guidewire at least 1.2 cm
distal to the aneurysm neck.
note: The microcatheter tip must be placed sufficiently distal to the
aneurysm neck to allow for slack to be removed from the system after the
stent is advanced, while maintaining adequate stent length (approximately
4 mm) distal to the aneurysm neck. Excessive tortuosity may necessitate
microcatheter tip placement more than 1.2 cm distal to the aneurysm neck.
3. Remove the guidewire.
Black (K) ∆E ≤5.0
4. Select an appropriate Neuroform Atlas Stent based on the largest reference
Magnetic Resonance Conditional
Resonancia magnética, condicional
MR vessel diameter and the sizing recommendations in Tables 1 and 2. Select
Résonance magnétique - Sous réserve
Magnetresonanz, bedingt a stent that is at least 8 mm longer (referenced off the working length, WL)
Risonanza magnetica – Con riserva
than the aneurysm neck to maintain a minimum of 4 mm on each side of the
MRI-veilig onder bepaalde voorwaarden
Ressonância magnética - utilização
aneurysm neck along the parent vessel.
condicional
Magnetisk resonans - betinget
Delivery system preparation and stent transfer
Για χρήση σε περιβάλλον αγνητικού
συντονισ ού υπό συνθήκη
Säker under vissa förhållanden vid
magnetisk resonans
note: Coiling can be performed by placing the microcatheter into the
MR-környezetben feltételesen
biztonságos aneurysm prior to or after stent deployment, per physician preference.
Magnetická rezonance – podmínečná
Rezonans magnetyczny – produkt
warunkowo bezpieczny
5. Carefully inspect the stent delivery system packaging for damage.
MR-sikker under visse betingelser
Manyetik Rezonans Uyumlu
6. Peel open the pouch using aseptic technique and remove the (sterile)
MRI-ehdollinen
dispenser hoop.
Uvjetno odobreno za magnetsku
7. Carefully place the dispenser hoop into the sterile field.
rezonanciju
Magnetická rezonancia – podmienená
8. Using two hands, one on each side of the wire retention clip, release the stent
Rezonan ă magnetică – condi ională
Uporaba magnetne resonance pri
delivery wire from the wire retention clip on the dispenser hoop.
določenih pogojih
Tingimuslik sobivus
9. Remove the device from the dispenser hoop by grabbing the stent delivery
magnetresonantskeskkonda
Magnētiskā rezonanse –
wire and the proximal end of the introducer sheath; holding them together,
noteiktos apstākļos
Su magnetinio rezonanso
slowly and carefully remove the entire wire and introducer sheath.
tyrimu suderinamas
-
条件性核磁共振兼容
note: The stent delivery wire and proximal end of the introducer sheath must
자기 공명 조건부
be held together when removing the Neuroform Atlas Stent System from the
dispenser hoop to prevent stent movement and premature deployment.
note: Ensure that the stent delivery wire does not move relative to the
introducer sheath during removal of the stent system from the dispenser hoop.
10. Inspect the stent delivery system. Confirm that the tip of the stent delivery
wire is entirely within the introducer sheath. Confirm that the stent delivery
wire is not kinked and that the introducer sheath tip is not damaged.
11. Partially insert the distal end of the introducer sheath into the RHV that
is connected to the microcatheter. Tighten the RHV firmly to secure the
introducer sheath.
note: Partial insertion of the introducer sheath into the RHV is necessary to
ensure a flow path for flush. Ensure that the tip of the introducer sheath is
inserted into the middle of the RHV.
note: Under-tightening the RHV may result in inadequate flushing. Over-
tightening the RHV may crush the introducer sheath and may result in
inadequate flushing.
12. Open the y-connector valve of the RHV that is connected to the appropriate
flush solution and verify that fluid exits the proximal end of the introducer
sheath.
warning: Purge the system carefully to avoid the accidental introduction of
air into the stent system.
13. Loosen the RHV, then advance the introducer sheath until the tip is fully
inserted into the microcatheter hub. Tighten the RHV firmly.
warning: Confirm there are no air bubbles trapped anywhere in the stent
system.
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