INVATEC Mo.Ma Ultra Gebrauchsanleitung Seite 7

on the basis of the patient's condition and the experience of the
interventionalist.
− Confirm the compatibility of other devices (guidewires, balloon
dilatation catheters, stent delivery systems, etc.) with the Mo.Ma
Ultra system before use.
− Due to the presence of phthalates in the product, the clinician must
weigh the medical benefits of product use against the drawbacks
of phthalate exposure for children and pregnant or nursing women.
POTENTIAL COMPLICATIONS / ADVERSE EFFECTS
The complications that may result from a carotid balloon dilatation
and stenting procedure, aided by a proximal flow blockage cerebral
protection device, include but are not limited to:
Puncture related:
− Local hematoma
− Local haemorrhage
− Local or distal thromboembolic episodes
− Thrombosis
− Arterio-venous fistula
− Pseudoaneurysm
− Local infections
Procedure related:
− Bradycardia
− Hypotension
− Carotid artery spasm
− Dissection of the carotid arteries
− Air emboli
− Cerebrovascular accident (Stroke (ischemic, hemorrhagic), TIA)
− Acute myocardial infarction (unstable angina)
− Intravascular stent migration
Angiography related:
− Hyper-/ Hypotension
− Pain and tenderness
− Arrhythmias
− Sepsis/infection
− Systemic embolization
− Endocarditis
− Short-term hemodynamic deterioration
− Death
− Drug reactions
− Allergic reaction to contrast medium
− Pyrogenic reaction
PREPARATION TECHNIQUE
1. Prior to use, carefully examine the entire Mo.Ma Ultra Proximal
Cerebral Protection Device for defects or damage during shipment.
2. Connect the hemostatic working channel valve to the proximal port
of the connector (1).
3. Flush the working channel with saline solution through the
hemostatic valve and extension tubing.
4. Flush the hollow mandrel with saline solution.
5. Insert the tip of the mandrel through the hemostatic valve and into
the working channel. Advance the mandrel completely.
6. Close the hemostatic valve (by rotating the upper cab) in order to
block the mandrel in the correct position.
PURGING
7. Prepare the supplied 30 ml syringe filled with 10 ml contrast/saline
mix (30/70 – 50/50).
for Mo.Ma double balloon
8. Prepare in sequence both the inflation line as follow: screw the
syringe to the inflation line, - ECA distal balloon / CCA proximal
balloon.
9 Keeping the syringe downward, draw vacuum and wait for about
15 seconds, till no air bubbles raise from the device.
0110079-7.indd 7
10. Keeping the tip downward get back to ambient pressure (release
the syringe plunger).
11. Detach the syringe from the device. Repeat the previous point for
the remaining inflation line.
for Mo.Ma mono balloon
8. Prepare the inflation line as follow: screw the syringe to the
inflation line- CCA balloon.
9. Keeping the syringe downward, draw vacuum and wait for about
15 seconds, till no air bubbles raise from the device.
10. Keeping the tip downward get back to ambient pressure (release
the syringe plunger).
11. Detach the syringe from the device.
Make sure that a drop of solution raise from the luer port as proof of
purging correctly done.
The device is now purged
DEVICE INSERTION, POSITIONING, ORIENTATION
for Mo.Ma double balloon
1. After a standard retrograde, femoral approach, dilate the puncture
site for insertion of a 9F [8F] long (about 25 cm long) introducer
sheath.
2. Under fluoroscopic control, using standard diagnostic technique,
engage the ECA with a 0.035" super-stiff guidewire.
3. Carefully introduce the proximal section of the 0.035" guidewire
into the white distal tip valve (9."fish-mouth-valve"), which is
mounted on the distal tip of the Mo.Ma Ultra system. After
engaging the distal tip of the mandrel, continue advancing the
guidewire all through the mandrel length.
4. Make sure that the guidewire enters the tip of the hollow mandrel,
by which the working channel is occluded.
5. Advance the Mo.Ma Ultra system (including mandrel) under
fluoroscopy over the wire through the 9F [8F] introducer until
the distal marker (on the ECA balloon) is positioned in the ECA
close to the carotid bifurcation and max. 1.5 cm distally from the
bifurcation ostium.
WARNING: Place the ECA balloon sufficiently deep into the ECA, so
that the distal balloon (ECA balloon) cannot slip back into the CCA.
However, do not place the ECA balloon deeper than 1.5 cm (measured
from the ostium into the ECA) to avoid CCA proximal balloon
interference with the stent placement.
6. The proper orientation of the working channel exit port towards the
ICA can be checked by the proximal marker band. Preferably this
should point towards the ICA ostium.
7. Once the Mo.Ma Ultra is in place, open the hemostatic valve,
remove the mandrel and, as soon as back bleeding occurs, close
the hemostatic valve, leaving the 0.035" guidewire in place.
for Mo.Ma mono balloon
1. After a standard retrograde, femoral approach, dilate the puncture
site for insertion of an 8F long (about 25 cm long) introducer
sheath.
2. Under fluoroscopic control, using standard diagnostic technique,
engage the CCA with a 0.035" super-stiff guidewire.
WARNING: Do not cross the lesion with any wire until the Mo.Ma Ultra
is in place.
3. Carefully introduce the proximal section of the 0.035" guidewire
into the distal tip of the mandrel of the Mo.Ma Ultra system and
continue advancing the guidewire all through the mandrel length.
4. Advance the Mo.Ma Ultra system (including mandrel) under
fluoroscopy over the wire through the 8F introducer until the
marker is positioned in the CCA min. 3 cm proximal from the lesion
or the carotid bifurcation.
5. Once the Mo.Ma Ultra is in place, open the hemostatic valve and
remove the mandrel together with the 0.035" guidewire.
BALLOON INFLATION, FLOW BLOCKAGE
for Mo.Ma double balloon
CAUTION: Use only the supplied 30 ml syringe with fix male Luer +
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