Straub Medical Aspirex S 6F 110cm Mode D'emploi page 9

Straub Medical AG
®
Aspirex S Catheter
WARNING: Manoeuvring the catheter through areas with very hard, especially heavily calcified plaques, requires special care. These
plaques may protrude into the vessel lumen. If the catheter is advanced too quickly, the tips of the plaque are eroded only partially or not at
all, and may get into the side window of the catheter head, where they are exposed to such a strong torque that the plaque may be torn out
of the vessel wall.
2. Adequately slow catheter advancement mitigates the risk of both distal embolization and shorn plaque.
3. Once the material removable in this way is completely aspirated, withdraw the catheter to the starting point while keeping the motor running
continuously. While doing so, constantly rotate the catheter between the fingers so that the lateral aspiration windows will aspirate any material
still to be aspirated.
4. The motor can be deactivated once the starting point has been reached. Perform an angiogram to determine the status of the treated vessel
segment.
CAUTION: If the catheter is removed in order to take the angiogram, it must be rinsed as described above. Reinsert the rinsed catheter into the
blood vessel to restart the procedure.
5. Catheter use can be repeated several times in order to achieve the optimal treatment outcome.
6. To complete the treatment with the Aspirex
WARNING: Further treatment of used products and their disposal need to be handled in accordance with international medical codes of
practice, taking into consideration relevant local laws.
Troubleshooting:
Error / Problem / Trouble
No aspiration
Insufficient filling of
catheter lumen during
procedure
Insufficient blood flow to
the collecting bag
Acoustic alarm on control
unit
Catheter shaft gets hot
Guidewire can no longer
be moved within the
catheter and becomes hot
or rotates with the helix
References:
[1] Pinto, D.S. et al., Association of an activated clotting Time ≤ 250 seconds with adverse event rates after percutaneous coron ary interventions using tirofiban and heparin (a TACTICS-TIMI 18 substudy), The American Journal of
Cardiology Vol 91, Nr.8, April 15, 2003, p. 976-978
[2] Hirsh, J. et al., Beyond unfractionated Heparin and Warfarin: current and future advances, Circulation 2007; 116; p.552-560
[3] Buller, CE. et al., Catheter thrombosis during primary percutaneous coronary intervention for acute ST elevation myocardial infarction despite subcutaneous low-molecular-weight heparin, acetylsalicylic acid, clopidogrel and
abciximab pre-treatment, Canadian Journal of Cardiology 2006 May 1; 22 (6):511-5
11121 A1
®
S catheter, switch off the motor and carefully remove the catheter via the introducer sheath.
Possible cause
1. Blocked catheter head prevents the helix
from rotating. This is why no negative
pressure is produced.
2. Blockage in the area of the catheter head /
tube or the helix: prevents blood flow to the
collecting bag Catheter lumen is running dry.
3. Hole in the catheter shaft: if the catheter
shaft has been squeezed with the motor
activated, the shaft might be perforated.
4. Broken helix: if the catheter has been
kinked before or during the procedure or if
the continuous manual back-and-forth
movements are not performed during
rotation, the helix might break.
If the number of revolutions of the catheter
falls below a critical level, an intermittent
warning signal will sound. If the number of
revolutions falls to zero, a continuous
warning signal will sound.
The head is not supplied with enough
liquid, the catheter lumen is inadequately
filled with liquid or there is insufficient
blood flow to the collecting bag.
Helix and guidewire might be bonded
together by fibrin.
anticoagulation may be the cause (see
"Precautions" above).
© Straub Medical AG
EN
Instruction For Use
Remark
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.
If the helix does not rotate despite the motor being
activated, it might be blocked with a foreign body.
Press the "return" key on the Straub Medical Drive
System while pressing the hand- or footswitch to allow
the catheter head to move briefly in the opposite
direction, which should clear the blockage. Then flush
the catheter with heparinised isotonic saline as
described above. If these measures are not successful,
the catheter must no longer be used and needs to be
replaced to continue the treatment.
The catheter must no longer be used and needs to
be replaced to continue to treatment.
The catheter must no longer be used and needs to
be replaced to continue the treatment.
CAUTION: Carefully remove catheter and guidewire
together. Ensure that no parts of the catheter or the
guidewire are left behind.
The cause of the problem must be remedied before
the treatment is continued.
To continue the treatment, ensure there is a
sufficient supply of liquid to the head, adequate filling
of the catheter lumen and a sufficient blood flow to
the collecting bag.
Catheter and guidewire must no longer be used and
Insufficient need to be replaced to continue the treatment.
CAUTION: Carefully remove catheter and guidewire
together. Ensure that no parts of the catheter or the
guidewire are left behind.
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