Directions For Use - Stryker Excelsior Sl-10 Gebrauchsanweisung

Steam Shaping
Microcatheters are packaged with a steam shaping mandrel for use when the physician desires to shape
the distal tip.
warning: Shaping mandrel is not intended for use inside the human body.
al
To maintain the integrity of the inner diameter of the microcatheter, it is recommended that the steam shaping
instructions be strictly followed.
1. Remove shaping mandrel from packaging card and insert the mandrel's entire working length into the
microcatheter's distal lumen.
. Flush or dip microcatheter tip into saline to aid mandrel movement, bend the working length of the
shaping mandrel to desired microcatheter shape.
3. Shape microcatheter by holding mandrel/microcatheter assembly no closer than .54 cm (1 in) from
steam source for approximately 10 seconds.
es
Caution: Do not position microcatheter closer than .54 cm (1 in) from the steam source. Damage to the
microcatheter may result.
4. Remove mandrel from microcatheter and discard. Multiple shaping is not recommended.
Continuous flush
The recommended continuous flush set up is illustrated in Figure 1. The RHVs provide a fluid tight seal and are
attached to the guide catheter and microcatheter. The stopcocks attach to the RHV sidearm, which become
infusion ports for appropriate flush or contrast media injection.
Caution: Check that all fittings are secure so that air is not introduced into guide catheter or microcatheter
during continuous flush.
Caution: In order to achieve optimal performance of Stryker Neurovascular Microcatheters and to maintain
the lubricity of the Hydrolene® Coating surface, it is critical that a continuous flow of appropriate flush
solution be maintained between the Stryker Neurovascular Microcatheter and guide catheter, and the
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microcatheter and any intraluminal device. In addition, flushing aids in preventing contrast crystal formation
ain
and/or clotting on both the intraluminal device and inside the guide catheter and/or the microcatheter lumen.
to
Line to flush solution
40 kPa (300 mm Hg)
Guide
Catheter
Microcatheter
Radiopaque
Tip Markers
figure 1. Example of Continuous flush Setup

Directions for Use

1. Place appropriate guide catheter according to the manufacturer's instructions.
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. Open RHV thumb-screw and carefully introduce microcatheter and guidewire assembly through the
e.
guide catheter RHV (Second RHV in Figure 1). Tighten the O-ring valve around the microcatheter just
enough to prevent back flow, but not so tightly as to inhibit microcatheter advancement.
Caution: Excessive tightening of a hemostatic valve onto the microcatheter shaft may result in damage
to the microcatheter.
3. Advance microcatheter tip by carefully rotating torque device on proximal end of guidewire. Hold
er.
proximal end of guidewire and microcatheter in a straight line to enhance transmission of rotational
energy from proximal to distal end.
Stopcock
3 cm (3 cc) Syringe
3
First RHV
Second RHV
Microcatheter
Hub
Stryker Neurovascular
Steerable Guidewire
Line to flush solution
40 kPa (300 mm Hg)
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. This step is best accomplished by two people.
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 2. flow rate Table
Microcatheter
Excelsior® SL-10
warning: Do not exceed ,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.
rEQUIrED aDDITIOnaL ITEMS
• Two 3 cm (3 cc) syringes and saline flush bags to apply saline to the coils before deployment
3
• Continuous flush setup with two rotating hemostatic valves (RHVs) (Tuohy-Borst type)
• Two stopcocks
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
Torque Device
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.
Stopcock
3 cm (3 cc) Syringe
3
3
approximate flow rates at
2,070 kPa (300 psi) cm
Shaft Micro- Dead
Length catheter ID Space
water
(cm) (mm/in) (cm 3 )
(cm /sec)
3
150 0.4 (0.0165 in) 0.9 0.78
(3 cc) syringes, and
3
3 /sec
60% 76%
Contrast Contrast
(cm /sec) (cm /sec)
3 3
0.17 0.08