Excelsior Xt; Directions For Use - Stryker Excelsior XT-27 Gebrauchsanweisung

DIrECTIOnS FOr USE

1. Place appropriate guide catheter according to the manufacturer's instructions.
2. Open RHV thumb-screw and carefully introduce microcatheter and guidewire assembly through the
guide catheter RHV (first RHV in Figure 1) using the peel-away introducer sheath if microcatheter tip
is shaped. Tighten the O-ring valve around the microcatheter just enough to prevent back flow, but not
so tightly as to inhibit microcatheter advancement. Remove the peel-away introducer sheath from the
microcatheter by retracting the introducer from the RHV and pulling the tab.
Caution: Excessive tightening of a hemostatic valve onto the microcatheter shaft may result in damage
to the microcatheter. Removing the peel-away introducer sheath without a guidewire inserted in the
microcatheter lumen might result in damage to the microcatheter shaft.
3. Advance microcatheter tip while carefully rotating torque device on proximal end of guidewire. Hold
proximal end of guidewire and microcatheter in a straight line to enhance transmission of rotational
energy from proximal to distal end.
4. Advance the guidewire a short distance, then alternately track the microcatheter over the guidewire
until selected site is reached. The guidewire may also be slowly retracted during microcatheter
advancement.
5. To infuse, completely remove the guidewire from the microcatheter, connect 3 cm
infuse as required. Monitor infusion pressures with a syringe manometer device whenever practical.
warning: Discontinue use of microcatheter for infusion if increased resistance is noted. Resistance
indicates possible blockage. Remove and replace blocked microcatheter immediately. DO NOT attempt
to clear blockage by over-pressurization. Doing so may cause the microcatheter to rupture, resulting in
vascular damage or patient injury.
Table 3. Flow rate Table
Shaft
Microcatheter
Microcatheter Length
ID (mm/in)
(cm)
Excelsior® XT-27™ 135 0.69 (0.027 in)

Excelsior XT-27

150 0.69 (0.027 in)
Excelsior®
135 0.69 (0.027 in)
XT-27™ Flex
Excelsior XT-27 Flex 150 0.69 (0.027 in)
warning: Do not exceed 2,070 kPa (300 psi) infusion pressure. Excessive pressure could dislodge a clot,
causing thromboemboli, or could result in a ruptured microcatheter or severed tip, causing vessel injury.
6. To deliver an interventional device, completely remove the guidewire from the microcatheter and deliver
the interventional device according to its specific directions for use.
warranTy
Stryker Neurovascular warrants that reasonable care has been used in the design and manufacture of this
instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein,
whether express or implied by operation of law or otherwise, including, but not limited to, any implied
warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization
of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and
other matters beyond Stryker Neurovascular's control directly affect the instrument and the results obtained
from its use. Stryker Neurovascular's obligation under this warranty is limited to the repair or replacement of
this instrument and Stryker Neurovascular shall not be liable for any incidental or consequential loss, damage
or expense directly or indirectly arising from the use of this instrument. Stryker Neurovascular neither
assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility
in connection with this instrument. Stryker neurovascular assumes no liability with respect to instruments
reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited
to merchantability or fitness for a particular purpose, with respect to such instruments.
Tyvek is a trademark of E.I. du Pont de Nemours and Company.
Black (K) ∆E ≤5.0
3 (3 cc) syringes, and
approximate Flow rates at
2,070 kPa (300 psi) cm /sec
3
approximate
Dead Space
100% 100% Ionic 100% non-
(cm 3 )
Saline Contrast 76 Ionic Contrast
(cm /sec) (cm /sec) 300 (cm
3 3
0.63 2.8 0.6 1.0
0.68 2.7 0.5 0.8
0.63 2.8 0.6 1.0
0.68 2.7 0.5 0.8
/sec)
3
4
E
E