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N. USING
THE
RESERVOIR
AUTOTRANSFUSION
To use the cardiotomy/venous reservoir for post-
operative autotransfusion, proceed as follows:
1) Disconnect the purge lines.
2) Disconnect the arterial sampling line from the
sampling manifold.
3) Separate the venous reservoir from the
oxygenating module.
4) Close all the ports of the cardiotomy/venous
reservoir used during bypass, including the
VENT/VACUUM port.
5) If
performing
(VAVD), please read carefully section L of these
instructions for use.
WARNING
• When using the cardiotomy/venous reservoir
for
post-operative
attention when administering protamine
because excessive dosage may cause thrombus
formation in the cardiotomy/venous reservoir.
O. HORIZON CVR REPLACEMENT
A spare device must always be available during
perfusion.
After 6 hours of use with blood or if the perfusionist
is of the opinion that the conditions are such that
the safety of the patient may be compromised
(insufficient performance, leaks, abnormal blood
parameters, etc.), replace the cardiotomy/venous
reservoir following the instructions below.
CAUTION
Use
a
sterile
technique
replacement procedure.
1) If
performing
(VAVD), please read carefully section L of these
instructions for use.
2) Turn the main pump and the suction pump off.
3) Close the venous return and the blood outlet
lines, using two clamps (5 centimetres apart).
4) Cut the venous return and the blood outlet lines
in the section between the two clamps, leaving a
sufficient length of tubing to allow reconnection.
5) Remove all the sampling lines, the suction
lines, and in any case all the connection to the
HORIZON CVR cardiotomy/venous reservoir.
6) Remove HORIZON CVR from the holder.
7) Place a new HORIZON CVR on the holder.
36
CARDIOTOMY/VENOUS
FOR
POST-OPERATIVE
vacuum-assisted
autotransfusion,
throughout
vacuum-assisted
Connect all the lines (inlet, outlet, other
connection lines, vacuum line, sampling lines,
etc.).
8) Verify all connections and secure with ties.
9) Prime New HORIZON CVR as described in
Section G Prime Procedure.
10) Remove the clamps from the venous and the
arterial lines, close the oxygenator purge line
and restart the bypass.
11) The residual blood in the replaced cardiotomy/
venous reservoir may be recovered by
connecting the outlet to the 3/8" inlet on the
turret of the new cardiotomy/venous reservoir.
drainage
P. MEDICAL DEVICES FOR USE WITH HORIZON
CVR
The device can be integrated into any perfusion
system.
At present EUROSETS is not aware of any
contraindication to use of the device with occlusive
pay
pumps or centrifugal pumps. The use of other types
of pumps must be agreed with EUROSETS.
The circuit connections must be made using tubes
of a diameter compatible with the dimensions of the
ports on the device (3/8").
When using the vacuum-assisted drainage (VAVD),
please read carefully section L of these instructions
for use.
Eurosets recommends the use of YSI 400 series
temperature probes.
Q. LIMITED WARRANTY
These warranty conditions are in addition to any
statutory rights of the purchaser pursuant to
applicable law.
EUROSETS warrants that all reasonable care has
the
been taken in the manufacture of this medical
device as required by the nature of the device and
drainage
the use for which the device is intended.
EUROSETS warrants that the medical device
is capable of functioning as indicated in these
instructions for use when used in accordance with
them by a qualified user and before any expiry date
indicated on the packaging.
Nonetheless, EUROSETS cannot guarantee that
incorrect diagnosis or therapy and/or the particular
physical and biological characteristics of an
individual patient do not affect the performance
and effectiveness of the device with damaging
consequences for the patient, even though the
specified instructions for use have been respected.
