Stryker Excelsior 1018 Mode D'emploi page 3

secondary shaping
The Pre-Shaped Microcatheters are packaged with a steam shaping mandrel for use when the physician desires to provide a
secondary shape proximal to the pre-shaped distal tip. To maintain the integrity of the inner diameter of the microcatheter, it is
recommended that the following steam shaping instructions be strictly followed.
warning: Shaping mandrel is not intended for use inside the human body.
1. Remove packaging mandrel from microcatheter tip and discard.
2. Remove shaping mandrel from packaging card and insert mandrel's entire working length into microcatheter's distal lumen.
Flush or dip microcatheter tip into heparinized normal saline to aid mandrel movement.
3. Bend working length of shaping mandrel, proximal to the shaped distal tip, to desired shape.
4. Shape microcatheter by holding mandrel/microcatheter assembly no closer than 2.54 cm (1 inch) from steam source for
approximately 10 seconds.
Caution: Do not position Pre-Shaped Microcatheter closer than 2.54 cm (1 inch) from the steam source. Damage to the
Pre-Shaped Microcatheter may result.
5. Remove mandrel from microcatheter and discard. Multiple shaping is not recommended.
Continuous Flush
The recommended continuous flush set up, as illustrated in Figure 1, requires two stopcocks, two rotating hemostatic valves
(RHV) (Tuohy-Borst type), and two 3 cm 3 (3 cc) syringes. 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 microcatheter and any intraluminal device. In addition, flushing aids
in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guide catheter and/or the
microcatheter lumen.
Stopcock
Line to flush solution
40 kPa (300 mm Hg)
Second RHV
Microcatheter
Guide
Catheter
Stryker
Microcatheter
Neurovascular
Steerable
Guidewire
Radiopaque
Tip Markers
Figure 1. example of Continuous Flush setup
Directions for Use
1. Place appropriate guide catheter according to the manufacturer's instructions.
2. Open the RHV thumb screw and carefully introduce the microcatheter and guidewire assembly through the guide catheter
RHV using the peel away introducer. 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 the microcatheter tip by 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.
Advance the microcatheter and guidewire assembly to the tip of the guide catheter. Remove the peel away introducer from
the microcatheter shaft by retracting the introducer from the RHV and pulling the tab.
Caution: To facilitate microcatheter handling, the proximal portion of the microcatheter does not have the hydrophilic
surface. Greater resistance may be encountered when this section of the microcatheter is advanced into the RHV.
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.
3 cm 3 (3 cc) Syringe
Torque Device
First RHV
Stopcock
Hub
3 cm 3 (3 cc) Syringe
Line to flush solution
40 kPa (300 mm Hg)
5. To infuse, completely remove the guidewire from the microcatheter, connect 3 cm
Monitor infusion pressures with a syringe manometer device whenever practical.
warning: Discontinue use of the microcatheter for infusion if increased resistance is noted. Resistance indicates possible
blockage. Remove and replace the 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. Infusion pressure & Flow rates
shaft
Microcatheter Model length
(cm)
excelsior ® 1018 ® pre-shaped 150
warning: Do not exceed maximum infusion pressure indicated in Table 2. Excessive pressure could dislodge a clot, causing
thromboemboli, or severed tip, causing vessel injury.
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.
3
(3 cc) syringe, and infuse as required.
3
Dead approx. Flow rate (cm 3 /sec)
space @ Infusion pressure 2,070 kpa (300 psi)
volume
(cm 3 ) water 60% Ionic Contrast 76% Ionic Contrast
0.35 1.10 0.30 0.14