Straub Medical Aspirex S 6F 110cm Mode D'emploi page 8

Straub Medical AG
®
Aspirex S Catheter
the position of the guidewire.
WARNING: Do not start using the product before these preparatory measures have been completed.
®
Use of the Aspirex S catheter:
1. Now switch on the Straub Medical Drive System.
CAUTION: Straub Medical catheters should only be applied or used under adequate visual monitoring with suitable radiographic
techniques.
WARNING: Before switching on the motor always visually check the entire catheter carefully, if necessary by suitable radiographic
techniques. Do not run the motor if there is any damage or functional impairment.
WARNING: The catheter must never be kinked at any stage. There is a risk of a kink developing for instance when passing the catheter
through kinked introducer sheaths or kinked guide catheters or when passing the catheter through narrow radii. If the tube kinks, the
catheter will be destroyed by the rotating helix. This can be seriously harmful to the patient.
WARNING: At no point should the catheter ever be exposed to pressure that is sufficient to compress the tube so that it is pressed against
the rotating helix. There is a risk of producing this kind of pressure, for instance, if the catheter is firmly compressed between the fingers or
when the catheter is passed through narrow radii. The catheter may be destroyed if the tube is pressed against the rotating helix. This can
be seriously harmful to the patient.
WARNING: If used incorrectly, a catheter 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 catheter – even outside the body – or over-
insertion should be avoided.
CAUTION: Throughout catheter use in a patient, always ensure there is a sufficient flow of liquid to the catheter head in order to avoid
collapse of the vessel/stent/graft/bypass graft as a result of the negative pressure produced by the catheter. If there is unlikely to be enough
natural flow of blood to the catheter head, the supply of liquid to the catheter head can be guaranteed by providing additional appropriate
liquid, such as isotonic saline, via a suitable access, such as the side-port of the introducer sheath being used.
WARNING:
The vessel/stent/graft/bypass graft
vessel/stent/graft/bypass graft collapses onto the catheter head, for example because there is insufficient flow of liquid to the catheter head.
This can be seriously harmful to the patient.
WARNING: The catheter lumen must be filled with liquid (heparinised isotonic saline or blood) at all times throughout catheter use in the
patient. Dry running can result in immediate disintegration of the catheter. Check that the catheter lumen is correctly filled throughout
catheter use by observing the blood flow through the transparent tube to the collecting bag. Filling of the catheter lumen is no longer
guaranteed if the blood flow decreases or is entirely cut off. If this happens, switch off the motor and remove the catheter. Further action is
described under the heading "Troubleshooting".
WARNING: Pushing the catheter or the guidewire against resistance may damage the guidewire, the catheter or the
vessel/stent/graft/bypass graft. If resistance is experienced, pull the catheter back a little way into the open(ed) segment with the motor
continuing to run so that the ablated material can be processed and carried away. Then switch off the motor and find out the cause of the
resistance by a suitable method. If any of the technical limitations or complications described above are present or there is any damage to
the vessel/stent/graft/bypass graft, re-assess or interrupt catheter use and take appropriate measures.
CAUTION: Blood and thrombus fragments in the catheter lumen might clot if the helix has stopped. Therefore, if catheter use is interrupted,
the catheter must be rinsed immediately in heparinised isotonic saline. To do this, remove the catheter and, outside the introducer sheath,
with the catheter still running over the guidewire, immerse the head in a shallow bowl of heparinised isotonic saline. With the head
immersed, switch on the motor and flush the whole of the catheter lumen until the rinsing solution running into the collecting bag becomes
clear and all the green LEDs on the LED bar on the Straub Medical Drive System are illuminated. Reinsert the catheter into the blood vessel
to restart the procedure.
2. The motor is activated by the hand- or footswitch. Monitor the revolution speed of the helix on the LED bar on the Straub Medical Drive
System. The green LEDs indicating correct speed should never go out completely at any stage of the procedure. The Straub Medical Drive
System is equipped with an acoustic warning system which emits an audible alarm if all the green LEDs are extinguished.
CAUTION: If the LEDs go out or the alarm is audible, safe functioning of the catheter is no longer guaranteed. With the motor still running,
immediately pull the catheter back into the open(ed) vessel segment to allow the system to stabilize.
WARNING: If withdrawing the catheter does not cause the alarm signal to stop and the green LEDs to light up again within a few seconds,
immediately deactivate the motor and remedy the cause of the problem before continuing the procedure.
3. With the motor running, hold the handle of the motor so that the outlet tube exiting from the gearbox housing of
the catheter is positioned vertically downwards. The collecting bag must hang vertically below the motor so that
the feed tube runs in a direct vertical line from the gearbox housing of the catheter as far as the collecting bag.
When the motor is running, position it at the same height as the introducer sheath and hold so that the section of
the catheter located outside the patient's body is completely straightened at all times.
CAUTION: If the activated motor is not kept at the same height as the introducer sheath, or if the section of the catheter located outside the
patient's body is not completely straightened at all times, or if the outlet tube does not run vertically and completely stretched from the
catheter into the collecting bag, technical problems such as blockage of the catheter, helix fracture or guidewire fracture may occur.
Treatment of the occlusion:
1. With the motor running, advance the catheter slowly as far as the distal end of the occlusion and simultaneously rotate the catheter between
the fingers. The rotation of the helix produced by the motor causes strong and constant negative pressure which aspirates the fresh thrombotic
or thromboembolic material and blood via the side window into the head. The material is sheared off and thus fragmented between the helix
and the inner edge of the side window. The aspirated material is carried away by the helix rotating inside the head and the catheter tube. The
suction produced and the blood flow from proximally feed the fresh occluding material not adhering to the wall towards the catheter head. At
the distal end of the occlusion, continue rotating the activated catheter between the fingers and keep the catheter in position until the material
thereby removable is completely aspirated.
WARNING: As the catheter is advanced through the occlusion, reduce the speed of catheter advancement to as little as one tenth of the
catheter head length per forward movement when reaching a distance of at least one catheter head length from the distal end of the
occlusion. Advancing the catheter too quickly increases the risk of this advancement mobilising more material than can be aspirated and
carried away, which can cause distal embolisation.
11121 A1
EN
Instruction For Use
may become seriously damaged
© Straub Medical AG
0408
or destroyed and/or dislodged if the
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