INVATEC Mo.Ma Ultra Gebrauchsanleitung Seite 9

BALLOON DEFLATION
for Mo.Ma double balloon
1. Prior to deflation remove the T-safety connector from the 30 cc
inflation syringe. Alternatively, any other syringe can be used for
deflation.
2. When the absence of any residual debris has been ensured,
deflate the distal balloon (ECA) under fluoroscopic control by
connecting the syringe to the distal inflation port and apply
negative pressure.
3. Deflate the proximal balloon (CCA) under fluoroscopy by
connecting the syringe to the proximal inflation port and by
applying negative pressure.
4. Perform control angiography of the Carotid Artery.
for Mo.Ma mono balloon
1. Prior to deflation remove the T-safety connector from the 30 cc
inflation syringe. Alternatively, any other syringe can be used for
deflation.
2. When the absence of any residual debris has been ensured,
deflate the balloon (CCA) under fluoroscopy by connecting the
syringe to the inflation port and by applying negative pressure.
3. Perform control angiography of the Carotid Artery.
SYSTEM WITHDRAWAL
1. Retract every guidewire out of the working channel.
2. Gently retrieve the Mo.Ma Ultra system under fluoroscopic control.
CAUTION: IMPORTANT NOTE ON BALLOON INFLATION
for Mo.Ma double balloon
CCA and ECA balloons are highly compliant type and are designed
to achieve atraumatic vessel occlusion by changing their shape from
circular to cylindrical thus featuring a wide balloon-vessel contact area
plus giving the operator an immediate angiographic feedback that
vessel occlusion has been achieved. For this reason a pressure guided
operation of the balloons must not be performed. Volumes needed to
occlude carotid vessels depend upon vessel diameters. In vitro testing
has shown that for the distal balloon, in case of the maximum considered
diameter of 6 mm, the volume needed to achieve cylindrical balloon
shape and thereby effective occlusion, should not exceed 0.3 cc. In the
same way, for the proximal balloon, in case of the maximum considered
diameter of 13 mm, the volume needed to achieve cylindrical balloon
shape and thereby effective occlusion, should not exceed 1.5 cc.
Common carotid vessel size require less volumes to achieve occlusion
than the above mentioned quantities. Therefore during inflation the
operator must carefully watch the fluoroscopic image in order to detect
the cylindrical shape deformation of the balloons.
for Mo.Ma mono balloon
The CCA balloon is highly compliant type and is designed to achieve
atraumatic vessel occlusion by changing its shape from circular to
cylindrical thus featuring a wide balloon-vessel contact area plus giving
the operator an immediate angiographic feedback that vessel occlusion
has been achieved. For this reason a pressure guided operation of the
balloon must not be performed. Volumes needed to occlude carotid
vessels depend upon vessel diameters. In vitro testing has shown
that for the balloon, in case of the maximum considered diameter of
13 mm, the volume needed to achieve cylindrical balloon shape and
thereby effective occlusion, should not exceed 1.5 cc. Common carotid
vessel size require less volumes to achieve occlusion than the above
mentioned quantities. Therefore during inflation the operator must
carefully watch the fluoroscopic image in order to detect the cylindrical
shape deformation of the balloons.
HOW SUPPLIED
The Mo.Ma Ultra Proximal Flow Blockage Cerebral Protection Device
is supplied sterile and intended for single use only. The Mo.Ma Ultra
system is sterilized by ethylene oxide gas. It will remain sterile as long
as the packaging remains unopened and undamaged. It is supplied with
double pouch. Use product by the date printed on the label.
CAUTION: Do not use if the inner package is open or damaged.
0110079-7.indd 9
STORAGE
Keep dry and away from sunlight. Store at controlled room temperature.
Do not expose to organic solvents (e.g. alcohol, acetone), ionizing
radiation or ultraviolet light. Rotate inventory so that catheters are used
by the date on package label.
DISPOSAL
After use, this product may be a potential biohazard. Handle and
dispose of all such devices in accordance with accepted medical
practice and applicable local, state and federal laws and regulations.
WARRANTY DISCLAIMER
Although this product has been manufactured under carefully controlled
conditions, Invatec has no control over the conditions under which
this product is used. Invatec therefore disclaims all warranties, both
expressed and implied, with respect to the product, including, but
not limited to, any implied warranty of merchantability or fitness for a
particular purpose. Invatec shall not be liable to any person or entity
for any medical expenses or any direct, incidental or consequential
damages caused by any use, defect, failure or malfunction of the
product, whether a claim for such damages is based upon warranty,
contract, tort or otherwise. No person has any authority to bind Invatec
to any representation or warranty with respect to the product.
The exclusions and limitations set out above are not intended to, and
should not be construed so as to contravene mandatory provisions
of applicable law. If any part or term of this Disclaimer of Warranty is
held to be illegal, unenforceable or in conflict with applicable law by
a court of competent jurisdiction, the validity of the remaining portions
of this Disclaimer of Warranty shall not be affected, and all rights and
obligations shall be construed and enforced as if this Disclaimer of
Warranty did not contain the particular term held to be invalid.
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