Medical Devices For Use With The D903 Avant Module; Return Of Used Products; Limited Warranty - Sorin Group D903 Avant Module Gebrauchsanweisung

2) Place two clamps on the oxygenator venous inlet line (at a 5 cm distance).
3) Stop the arterial pump and place two clamps on the arterial line (at a 5 cm
distance) near the oxygenator.
4) Stop the water flow to the heat exchanger, clamp and remove the water lines.
5) Remove the gas line and all the monitoring and sampling lines connected to the
venous reservoir.
6) Cut the oxygenator venous inlet line and the arterial line in the point between
the two clamps.
7) Remove the D903 AVANT MODULE to be substituted from the holder.
8) Place a new D903 AVANT MODULE on the holder. Connect all lines (i.e.
venous line, arterial line, water lines.).
During this phase the venous and arterial lines must be clamped.
9) Remove the clamps from the water line and switch the thermocirculator on.
Check the sealing of the heat exchanger of the new D903 AVANT MODULE.
10) Prime the new D903 AVANT MODULE and evacuate any air bubble, following
the priming and recirculation procedure.
11) Check the connections and seal them by means of ties.
12) Remove the clamps from the venous or arterial lines, close the
purging/recircualtion line and restart the by-pass procedure.
13) The blood contained in the oxygenating module and in the heat exchanger can
be recovered by connecting the arterial line to one of the venous reservoir inlets
and by gravity draining the D903 AVANT MODULE replaced.
L. MEDICAL DEVICES FOR USE WITH THE D903
AVANT MODULE
The device may be used in combination with a soft venous reservoir and an auxiliary
cardiotomy of no less than 2 lt, to achieve a closed system.
The device may be used in combination with a hardshell venous/cardiotomy
reservoir of no less than 2l, to achieve an open system. An arterial/venous sampling
system must also be used, taking care to check at the time of arterial connection,
that the male luer connector does not reach as far as the one-way valve placed
inside the arterial sampling luer in the oxygenator.
All tubing used to make the circuit connections must be of a diameter which is
compatible with the dimensions of the connectors on the device (3/8", 1/4").
Temperature controls must be carried out using SORIN GROUP ITALIA probes,
code 9026 or compatible to YSI Series 400.
Use Bird air/oxygen mixer (SORIN GROUP ITALIA code 9374) or a system with
compatible technical features.
Any heating/cooling system (thermocirculator) may be used, provided that the
connectors to the water distributor holder are of the Hansen type (SORIN GROUP
ITALIA code 9028).
Currently SORIN GROUP ITALIA is not aware of any contraindications to the use of
the device with occlusive or non-occlusive peristaltic pumps or with centrifugal
pumps. The use of other types of pump must be agreed with SORIN GROUP
ITALIA.
M. 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 information 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 understand 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 legislation 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 prevent 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
6
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
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 effectiveness 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
consequences 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 purpose.
No person, including any representative, agent, dealer, distributor or intermediary of
SORIN GROUP ITALIA or any other industrial or commercial organization is
authorized to make any representation or warranty concerning this medical device
except as expressedly 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 expressedly 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 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 jurisdiction. The
court chosen is the Court of Modena (Italy).
GB - ENGLISH