16) Remove the oxygenating module from the holder.
17) Place a new D 905 EOS oxygenating module on the holder.
18) Fix it by moving the water connector locking system to the
“CLOSE” position.
19) Connect the oxygenator inlet line and the arterial line to the oxy-
genating module
In this phase, keep the venous and arterial lines clamped.
20) Switch on the thermocirculator and check the heat exchanger.
21) Lift the reservoir and rotate the hook. Put the reservoir on the
oxygenating module. If possible couple the reservoir and the
oxygenating module by means of the white interface.
22) Connect the gas line, the arterial sampling line and all the mon-
itoring lines.
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.
N. 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 Bird air/oxygen mixer (SORIN GROUP ITALIA code 09374) 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.
O. RETURN OF USED PRODUCTS
Should the user be dissatisfied with anything related to the quality
of the product, the product distributor or the authorized local SORIN
GROUP ITALIA representative should be notified.
All parameters considered critical by the user must be reported with
particular care and urgency. The following is the minimum informa-
tion that should be provided:
• Detailed description of the event and, if pertinent, the conditions
of the patient;
• Identification of the product involved;
• Lot number of the product involved;
• Availability of the product involved;
• All the indications the user considers useful in order to under-
stand the origin of the elements of dissatisfaction.
SORIN GROUP ITALIA reserves the right to authorize, if necessary,
recall of the product involved in the notification for assessment. If
the product to be returned is contaminated, it must be treated,
packed and handled in conformity with the provisions of the legis-
lation in force in the country where the product was used.
It is the responsibility of the health care institution to adequately
prepare and identify the product for return shipment. Do not
return products that have been exposed to blood borne infectious
diseases.
ONLY for US customers
If for any reason the product must be returned to the manufacturer,
a returned good authorisation (RGA) number is required from Sorin
Group USA cardiovascular Inc. prior to shipping.
If the product has been in contact with blood or blood fluids, it must
be thoroughly cleaned and disinfected before packing. It should be
shipped in either the original carton or an equivalent carton to pre-
vent damage during shipment, and it should be properly labelled
with an RGA number and an indication of the biohazardous nature
of the content in the shipment.
The shipping address for returned goods in the US is:
Sorin Group USA, Inc.
Returned CV Products
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031.
P. 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
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 war-
ranty of merchantability and any warranty of fitness for purpose
with regard to this product other than what is expressly stated here-
in. The purchaser undertakes to comply with the terms of this
Limited Warranty and in particular agrees, in the event of a dispute
or litigation 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).
6
ENGLISH
WARNING
CAUTION
