INVATEC Mo.Ma Ultra Gebrauchsanleitung Seite 5

There are three different Mo.Ma
− 9F with 6F working channel compatible with 9F introducer sheath
− [8F with 5F working channel compatible with 8F introducer sheath] all information, particularly related to the 8F version will be indicated in
brackets [...]
– 8F with 5F working channel compatible with 8F introducer sheath – as Mo.Ma mono balloon
NOTE: In the following, these abbreviations will be used:
– Mo.Ma Ultra proximal Embolic Protection Device Double Balloon = Mo.Ma double balloon
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1 Y-piece with hemostatic valve and flexible extension tubing
(17 cm length)
2 Exit port of the working channel
3 Hollow mandrel, 0.035" guidewire compatible, to insert inside
the working channel during Mo.Ma Ultra introduction
4 Shaft with 9F [8F] outer diameter
5 3-way stopcock
6 Balloon inflation/deflation ports with attached 1-way stopcocks
(11) Mo.Ma double balloon 2 stopcocks, Mo.Ma mono balloon
1 stopcock
– Mo.Ma Ultra proximal Embolic Protection Device Mono Balloon = Mo.Ma mono balloon
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DEVICE NAME
The device brand name is Invatec Mo.Ma
Blockage Cerebral Protection Device; the generic device name is
embolic protection device.
DESCRIPTION
for Mo.Ma double balloon
Mo.Ma Ultra Proximal Cerebral Protection Device consists of a three-
lumen shaft (one working channel and two inflation-deflation lumen)
integrating two compliant balloons and a handle, which is located at the
proximal end. The compliant balloons can be independently inflated:
the proximal balloon in the Common Carotid Artery (CCA) and the distal
balloon in the External Carotid Artery (ECA). The balloons are mounted
on the distal portion of the shaft with the distal balloon close to the
tip and the proximal balloon at a distance of 60 mm from the distal
balloon (balloon markers relative distance), just before the exit port of
the working channel. The two compliant balloons can be inflated up to
13 mm (proximal, CCA balloon) and 6 mm (distal ECA, balloon).
A hollow mandrel is included in the packaging and is intended to
be inserted inside the Mo.Ma Ultra's working channel to improve
0110079-7.indd 5
Ultra versions
TM
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Ultra Proximal Flow
TM
2011-09-05 / 0110079-7
EN
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7 Distal balloon (ECA), with central radiopaque marker, occlusion
range up to Ø 6 mm
8 Proximal balloon (CCA), with central asymmetric marker,
occlusion range up to Ø 13 mm
9 Distal tip valve ("fish-mouth-valve")
10 3x filter baskets
11 1-way stopcock for connection to balloon inflation/deflation port
(6) Mo.Ma double balloon 2 stopcocks, Mo.Ma mono balloon
1 stopcock.
12 30 cc self-locking syringe
13 T-Safety Connector
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trackability during device insertion over a 0.035" (0.89 mm) guidewire.
The system is compatible with 9F [8F] introducer sheath, its usable
length (distance measured from the handle to the tip of the catheter)
is 950 mm and its total length (distance measured from the hemostatic
valve to the tip of the catheter) is 1.110 mm (please refer to the device
drawing at the previous page).
The working channel is a 0.083" (2.12 mm) [0.069" (1.76 mm)] internal
diameter fully usable lumen, with a length of 1,045 mm (distance
measured from the hemostatic valve to the exit port), which serves
as guiding catheter and as blood aspiration lumen. The exit-port of
the working channel is located between the two balloons allowing
easy access to the ICA.
Two radiopaque markers, one for each balloon, allow correct and
prompt device positioning. In addition the asymmetry of the proximal
marker allows correct and easy orientation of the exit-port of the working
channel towards the ICA in order to facilitate guidewire introduction.
A one way tip-valve located at the distal end of the device prevents
eventual backflow from the ipsilateral ECA to the brain through the ICA.
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