Medical Devices For Use With Synthesis 4D; Return Of Used Products; Limited Warranty - sorin SYNTHESIS 4D Instrucciones De Uso

- Its connection to the patient is the responsibility of the attending
surgeon.
- Use by untrained and unqualified personnel is not permitted.
- All the connections to the Sorin reservoir should be carried out with
the utmost care and rapidity in order to prevent contamination.
- The connections and the caps should be checked to assure that the
system is tight.
- Always keep the device in a vertical position: do not incline it, not
even when the patient is being moved.
- The SYNTHESIS reservoir must always be placed at a subthoracic
level so that its drainage functions can properly be performed.
- Activate the line vacuum following the instructions provided by the
manufacturer of the vacuum regulator.
- Any re-infusion of recovered blood is on the responsibility and at
the discretion of the attending physician
N. MEDICAL DEVICES FOR USE WITH
SYNTHESIS 4D
The centrifugal pump is intended for use only with Sorin Group
Deutschland Stöckert Centrifugal Pump Consoles. Refer to the console
operator's manual for console operating procedures.
- SYNTHESIS 4D holder code 050148
- Reservoir holder code 050546
- Stopcock holder code 050134
- Active Drainage and Vacuum Assist tubing packs (as required)
The circuit connections must be made with tubes of a diameter compatible
with the dimensions of the connectors located on the device (3/8", 1/4",
1/2").
Temperature control must be carried out with SORIN GROUP ITALIA
probes, code 09026 or YSI Series 400 compatible.
Use a Sechrist air/oxygen blender (Sorin Group Italia code 09046) or a
system with compatible technical features to control the blood gas
concentration.
Any heating/cooling system (thermocirculator) may be used, provided that
the connectors to the oxygenator are the Hansen type (Sorin Group Italia
code 09028).
O. RETURN OF USED PRODUCT
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 goods authorisation (RGA) number is required from Sorin
Group USA 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 USA 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 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
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
expressly stated herein.
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
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
GB – ENGLISH
any loss, damage, expense,
SORIN GROUP ITALIA disclaims any
the Court of Modena
incidents or
(Italy).
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