Medical Devices For Use With The D 905 Eos; Limited Warranty - dideco D 905 EOS Instrucciones De Uso

23) Remove the clamp from the venous line.
24) Keeping the recirculation line open (purging/ricirculation stop-
cock in "RECIRCULATION" position) prime the oxygenating
module through the arterial pump. Purge the air contained in the
module at a maximum flow rate of 2000 ml/min
25) Close the recirculation line (purging/recirculation stopcock in
"CLOSE" position.
26) Remove the clamp from the arterial line and restart the bypass.
27) Connect, if necessary, the cardioplegia line and purge it.
M. MEDICAL DEVICES FOR USE WITH THE D 905 EOS
For post-operative autotransfusion with the Venous Reservoir one
of the two following kits should be used:
- D 540 AUTOTRANSFUSION CONVERSION KIT code 05053.
- D 540 W AUTOTRANSFUSION CONVERSION KIT with water
seal, code 05062.
All tubing used to make the circuit connections must be of a diam-
eter which is compatible with the dimensions of the connectors on
the device (3/8", 1/4", 1/2").
Temperature controls must be carried out using SORIN GROUP
ITALIA probes, code 09026 compatible to YSI Series 400.
Use Sechrist air/oxygen mixer (SORIN GROUP ITALIA code 09046)
or a system with compatible technical features.
Any heating/cooling system (thermocirculator) may be used, pro-
vided that the connectors to the water distributor holder are of the
Hansen type (SORIN GROUP ITALIA code 09028).
Currently SORIN GROUP ITALIA is not aware of any contraindica-
tions to the use of the device with occlusive or non-occlusive peri-
staltic pumps or with centrifugal pumps. The use of other types of
pump must be agreed with SORIN GROUP ITALIA.
N. LIMITED WARRANTY
This Limited Warranty is in addition to any statutory rights of the
Purchaser pursuant to applicable law.
SORIN GROUP ITALIA warrants that all reasonable care has been
taken in the manufacture of this medical device, as required by the
nature of the device and the use for which the device is intended.
SORIN GROUP ITALIA warrants that the medical device is capable
of functioning as indicated in the current instructions for use when
used in accordance with them by a qualified user and before any
expiry date indicated on the packaging.
However, SORIN GROUP ITALIA cannot guarantee that the user will
use the device correctly, nor that the incorrect diagnosis or therapy
and/or that the particular physical and biological characteristics of
an individual patient, do not affect the performance and effective-
ness of the device with damaging consequences for the patient,
even though the specified instructions for use have been respected.
SORIN GROUP ITALIA, whilst emphasizing the need to adhere
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strictly to the instructions for use and to adopt all the precautions
necessary for the correct use of the device, cannot assume any
responsibility for any loss, damage, expense, incidents or conse-
quences arising directly or indirectly from the improper use of this
device.
SORIN GROUP ITALIA undertakes to replace the medical device in
the event that it is defective at the time of placing on the market or
whilst being shipped by SORIN GROUP ITALIA up to the time of
delivery to the final user unless such defect has been caused by
mishandling by the purchaser.
The above replaces all other warranties explicit or implicit, written or
verbal, including warranties of merchantability and fitness for pur-
pose. No person, including any representative, agent, dealer, dis-
tributor or intermediary of SORIN GROUP ITALIA or any other
industrial or commercial organization is authorized to make any rep-
resentation or warranty concerning this medical device except as
expressly stated herein.
SORIN GROUP ITALIA disclaims any warranty of merchantability
and any warranty of fitness for purpose with regard to this product
other than what is expressly stated herein.
The purchaser undertakes to comply with the terms of this Limited
Warranty and in particular agrees, in the event of a dispute or litiga-
tion with SORIN GROUP ITALIA, not to make claims based on
alleged or proven changes or alterations made to this Limited
Warranty by any representative, agent, dealer, distributor or other
intermediary.
The existing relations between the parties to the contract (also in the
case that it is not drawn up in writing) to whom this Warranty is
given as well as every dispute related to it or in any way connected
to it as well as anything related to it or any dispute concerning this
Warranty, its interpretation and execution, nothing excluded and/or
reserved, are regulated exclusively by the Italian law and jurisdic-
tion. The court chosen is the Court of Modena (Italy).