INVATEC Mo.Ma Ultra Gebrauchsanleitung Seite 8

T-safety connector for inflation of the balloons. The proper inflation
is NOT pressure depending, but to be angiographically controlled.
Do not use Mo.Ma Ultra in ECA reference diameters > 6 mm and in CCA
reference diameters > 13 mm.
1. Prepare the supplied 30 ml syringe filled with contrast/saline mix
(50/50 – 30/70) and connect it to T-safety connector.
2. Join together the T-safety connector with the one-way stopcock.
3. Connect the assembly to the syringe and, keeping the tip upward
flush it.
4. Ensure that no air bubbles remain in the syringe and in the
T-safety connector.
5. Join the assembly with the Mo.Ma Ultra inflation line previously
prepared.
6. Screw the assembly and make it secure connected with the
device. Screwing, handle the assembly by the one way stopcock.
7. With the one way stopcock open gently inflate the balloon.
8. In case of overpressure from the T-safety connector few drops of
water will escape.
9. As soon as balloon inflation is completed, turn the one way
stopcock from the present open-position 90 degrees to the closed-
position.
10. With the one way stopcock closed, detach the syringe and the
T-safety connector.
11. Inject 5 cc contrast dye through the working channel to ensure the
proper occlusion of the ECA.
12. After proper positioning of the distal balloon in the ECA, retrieve
the 0.035" guidewire from the ECA.
13. Repeat the same inflation procedure from number 1 to 11 for the
proximal (CCA) balloon.
for Mo.Ma mono balloon
CAUTION: Use only the supplied 30 ml syringe with fix male Luer +
T-safety connector for inflation of the balloon. The proper inflation is
NOT pressure depending, but to be angiographically controlled. Do not
use Mo.Ma Ultra in in CCA reference diameters > 13 mm.
1. Prepare the supplied 30 ml syringe filled with contrast/saline mix
(50/50 – 30/70) and connect it to T-safety connector.
2. Join together the T-safety connector with the one-way stopcock.
3. Connect the assembly to the syringe and, keeping the tip upward
flush it.
4. Ensure that no air bubbles remain in the syringe and in the
T-safety connector.
5. Join the assembly with the Mo.Ma Ultra inflation line previously
prepared.
6. Screw the assembly and make it secure connected with the
device. Screwing, handle the assembly by the one way stopcock.
7. With the one way stopcock open gently inflate the balloon.
8. In case of overpressure from the T-safety connector few drops of
water will escape.
9. As soon as balloon inflation is completed, turn the one way
stopcock from the present open-position 90 degrees to the closed-
position.
10. With the one- way stopcock closed, detach the syringe and the
T-safety connector.
CHECK OF FLOW BLOCKAGE
1. After the balloon(s) have been inflated, connect a syringe filled
with contrast/saline mix (50/50 – 30/70) to the side-port of the
working channel.
2. First try to aspirate slowly 10 cc of blood into the syringe.
NOTE: This is a prophylactic safety test, checking for the ability to
aspirate blood after the postdilation procedure from the ICA. In case it
will not be possible to aspirate blood through the working channel, the
reason in most of the cases will be the suction of the vessel wall onto
the working channel exit port.
3. Under fluoroscopic control slowly inject 5 cc of contrast/saline mix
and verify that contrast stagnation occurs at the carotid bifurcation.
0110079-7.indd 8
NOTE: If the total flow blockage is achieved in the CCA and ICA, the
contrast medium will stagnate in the occluded segment and can be
used as a kind of "road map" for the adequate positioning of any stent
or dilation balloon catheter.
CAUTION: Ensure that the injection of contrast medium with a
maximum of 5 cc is performed in a slow and controlled way. Do not
inject ANY more liquids during the following procedure.
4. Now the treatment of the Carotid Artery can be performed under
full cerebral protection.
CHECK OF PATIENT TOLERANCE
− Perform a continuous, very close monitoring of the patient, when
initiating the CCA occlusion. Observe the patient and talk to him in
order to verify his mental and physical tolerance of the unilateral
flow blockage. A whistling toy should be available to verify patient's
ability to squeeze it with his contralateral hand.
− Control and maintain patient systemic blood pressure in order to
avoid hypotension and hypertension.
− Should the patient manifest immediate or delayed intolerance after
inflation of the balloons, the operator must first aspirate blood until
no more debris appear on the microporus filter to prevent cerebral
embolism immediately followed by deflation of the proximal balloon
(CCA) in order to restore cerebral blood flow. Please refer to the
section "DEBRIS REMOVAL".
− At this point operator should wait a couple minute until the patient
has recovered from symptoms. Then re-inflate the proximal
balloon in order to check persistence of intolerance. In this case
it is the operator's responsibility to decide either to interrupt the
procedure or to use an alternative protection device (i.e. Filter).
CAUTION: Should the patient not tolerate the occlusion of the CCA,
the operator must first aspirate blood to prevent cerebral embolism
immediately followed by deflation of the proximal balloon (CCA) in order
to restore cerebral blood flow.
CAROTID TREATMENT PROCEDURE
− To treat the diseased ICA, the operator can use all material of
choice, which is compatible with 6F [5F] introducer sheaths. The
working channel of the Mo.Ma Ultra system has an inner fully
usable lumen diameter of 0.083" (2.12 mm) [0.069" (1.76 mm)]
and is used as guiding catheter or sheath for the advancement
and retrieval of guide-wires, pre and post dilatation balloon
catheters and carotid stent delivery systems.
− Carotid angioplasty and stenting are to be performed according to
standard technique and are left to operator's experience and skills.
− It is mandatory to leave the ICA guidewire across the treated
lesion, while the Mo.Ma Ultra is in place.
DEBRIS REMOVAL
CAUTION: At the end of the procedure, normally after post-dilating the
stented lesion, perform debris removal by blood aspiration, while the
Mo.Ma Ultra system with fully inflated balloons is still in place.
Before performing blood aspiration verify that the hemostatic valve in
the Mo.Ma Ultra connector is completely closed.
1. Connect a 20 cc empty syringe to the 3-way stop cock of the side
port (5.)
2. Properly close the hemostatic valve (1.)
3. Open the stop-cock and start slowly aspirating blood.
CAUTION: During aspiration, carefully monitor the patient due to any
occurring symptoms of intolerance.
NOTE: This procedure can be done at any stage during the intervention
but it is a must at least after post-dilatation of the stented lesion.
4. Slowly aspirate at least 60 cc of blood (3 syringes á 20 cc). Check
the last syringe for debris, by flushing the blood content through
the supplied microporous filter. If still debris are visible in the filter
basket, aspirate additional 20 cc syringes of blood, until no more
debris can be detected.
WARNING: If no blood can be aspirated through the working channel,
carefully advance a suitable guiding catheter through the working
channel, slightly distal from the working channel exit port. Aspirate now
60 cc through this guiding catheter.
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