Straub Medical Aspirex S 6F 110cm Mode D'emploi page 7

Straub Medical AG
®
Aspirex S Catheter
®
WARNING: Aspirex
S catheters may only be used in the indicated diameters of target vessels. If a catheter is inserted into an undersized
vessel diameter, the vessel can be ruptured by the catheter head. If used in an oversized vessel diameter, there is a risk that the thrombus
load will exceed the aspiration capacity of the catheter, causing all degrees of severity of embolisation.
WARNING: Do not use the Straub Mechanical Thrombectomy System if the introducer sheath, the Aspirex
kinked.
Introducing the guidewire:
1. Wet the sterile guidewire included in the catheter set by injecting heparinised isotonic saline into the guidewire dispenser. Then feed the
guidewire through the introducer sheath into the vessel and manoeuvre it through the vessel occlusion under radiographic monitoring. The
guidewire must lie inside the lumen throughout its course. Position the flexible tip of the guidewire as far distally as possible from the vessel
occlusion being treated.
CAUTION: Carefully extract the guidewire from the dispenser. If it cannot be extracted easily, inject additional heparinised isotonic saline.
The guidewire cannot be re-introduced into the dispenser after it has been extracted.
WARNING: If used incorrectly, a guidewire can traumatize and/or perforate the vessel being treated. Damage caused by vessel perforation
is often serious and can result in the patient's death. Incorrect manipulation, such as kinking of the guidewire – even outside the body – or
over-insertion should be avoided. A suitable insertion aid should be used.
Taking out the catheter and connecting it to the Straub Medical Drive System:
1. Remove the sterile catheter from its blister packaging contained in the catheter set. To connect the sterile catheter to the Straub Medical Drive
System (REF SRS Set) and connect the sterile collecting bag, consult the user manual of the Straub Medical Drive System (REF SRS Set).
WARNING: Do not connect the catheter to the Straub Medical Drive System or disconnect it while the motor is running. This could damage
the magnetic clutch.
Preparing the catheter for use:
1. The catheter lumen must be filled with heparinised saline before the catheter is inserted into the introducer sheath and the blood vessel. Fill
the catheter by injecting heparinised saline through the opening for the guidewire on the front of the catheter head. Draw up the heparinised
saline into a suitable sterile plastic syringe without a needle. During injection of the saline, keep the side openings in the catheter head closed
with the thumb and forefinger of one hand. Use the other hand to guide the syringe with its tip and press it firmly onto the catheter head from
the front. Inject enough solution to fill the catheter lumen entirely. Wet the catheter tip with heparinised saline in order to ensure smooth
introduction through the introducer sheath. If the catheter tip is still not sufficiently wetted after filling of the catheter tube, it must be immersed
in heparinised isotonic saline.
CAUTION: Ensure that the catheter lumen is completely filled with solution when the motor is running. Dry running can result in immediate
disintegration of the catheter.
2. When the catheter tip is wet and the catheter lumen is filled, insert the deactivated catheter immediately over the
guidewire through the introducer sheath into the blood stream. To prevent catheter kinking outside of the introducer
sheath, grasp the catheter at a maximum distance of 3 cm from the hemostatic valve and insert it in direction of the
longitudinal axis of the introducer sheath. Repeat this until the desired catheter length is inserted. To help the rigid
end of the guidewire to pass through the gearbox housing of the catheter, push the head of the wire adapter in the
direction of the gearbox housing.
3. Advance the catheter over the guidewire to 1 cm ahead of the occlusion with the motor switched off. This is the starting position for the use of
the catheter.
4. When the starting position is reached, re-check the position of the guidewire and correct it, if necessary.
WARNING: The catheter must always be guided via the guidewire, which has been correctly positioned according to the instructions for
use. Do not use the catheter without the guidewire or over a guidewire which is not correctly placed.
WARNING: Make sure that the flexible tip of the guidewire is placed as distal as possible to the occluded segment to prevent the flexible tip
from being aspirated into the catheter head.
WARNING: The guidewire must lie inside the lumen throughout its course from the introducing sheath to its flexible tip. If the position of the
wire is subintimal or otherwise extraluminal – even for short segments – the catheter might be guided against the vessel wall when it is
being advanced. This can result in vessel injuries such as dissection, perforation or rupture with potentially serious consequences for the
patient.
WARNING: When using the catheter in stents or stent grafts, check very carefully that the guidewire is correctly positioned within the stent /
stent graft lumen. Do not use the catheter if the guidewire has become threaded in the wire mesh of stent or stent graft or the lining of the
stent graft. Advancing the catheter over the threading point can seriously damage, destroy and/or dislodge the stent, stent graft or vessel.
WARNING: Do not operate the catheter in the fracture areas of broken stents or stent grafts, despite correct positioning of the guidewire. If
a protruding stent strut penetrates into the side window of the catheter head, such strong torque may be applied to the stent or stent graft
that the stent, stent graft or vessel are severely damaged or destroyed and/or dislodged, or the catheter head may get caught in the stent or
stent graft in such a way that the catheter and the stent or stent graft have to be surgically recovered.
WARNING: In native or synthetic bypass grafts or in native or synthetic dialysis accesses, only use the catheter if the anastomoses are
already healed and resilient and the graft is mature and well healed. If a catheter is inserted before the anastomoses have become resilient
and before a graft is mature and healed, the mechanical force exerted by the catheter on the occluding material and the vessel can cause
injury to the anastomoses and/or the vessel of all degrees of severity.
5. After the starting position for catheter use is reached and the correct position of the guidewire is achieved, pull out the
knob on the wire adapter away from the gearbox housing.
CAUTION: The wire adapter must be in the working position (knob pulled out) during use of the catheter.
WARNING: Under certain circumstances, the guidewire may become dislodged during catheter use. Monitor the
correct position of the guidewire throughout the entire process of catheter use. It is advisable to hold the section of
the guidewire emerging at the proximal end of the catheter firmly so that manipulations of the catheter cannot alter
11121 A1
EN
Instruction For Use
© Straub Medical AG
0408
®
S catheter or the guidewire are
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