Replacing The Cardioplegia Set; Medical Devices For Use With Cardioplegia Sets; Return Of Used Products; Limited Warranty - SORIN GROUP Vanguard D921 Instrucciones Para El Uso

temperature.
- Always make sure that the quantities of fluids for the cardioplegic perfusion
procedure are sufficient for the session and to ensure troublefree
extracorporeal circulation.
- Replace the asanguineous cardioplegic solution container in good time if
the amount it contains appears insufficient for completion of the delivery
procedure.
- Always monitor the system closely during the delivery of cardioplegic
solution. Air in the circuit constitutes a danger to the patient.
H. REPLACING THE CARDIOPLEGIA SET
A spare set should always be to hand during perfusion. If situations arise in which
the person in charge considers the patient is at risk, replace the set as described
below.
Use sterile techniques throughout the replacement procedure.
1) Stop the pump.
2) Place two clamps on the blood line connected to the coronary outlet of the
oxygenator (5 cm apart).
3) Switch off the thermocirculator, clamp and remove the water lines. Clamp the
asanguineous cardioplegic solution line.
4) Clamp the vent and pressure line and disconnect the temperature probe.
5) Place two clamps (5 cm apart) on the VANGUARD outlet line close to the heat
exchanger.
Version D924S and D928S
Ensure that the shunt between the blood line and the asanguineous cardioplegic
solution line is clamped.
6) Cut the blood line in the point between the two clamps and insert an
appropriate connector. Cut the outlet line at the point between the two clamps
and insert a 3/16"-3/16" connector.
7) Remove the spike from the asanguineous cardioplegic solution containers.
8) Remove the VANGUARD and the set for replacement from the holder.
9) Fit the new cardioplegia set. Connect all the lines (blood line to the appropriate
connector, outlet line to the 3/16"-3/16" connector, vent line, pressure line and
temperature line, water inlet and water outlet lines). Remove the clamps from the
blood line, the outline line and the asanguineous cardioplegic solution line.
10) Remove the clamps from the water line and switch on the thermocirculator;
check the new BCD VANGUARD for leaks.
11) Prime the new circuit and vent any air bubbles, as described in the priming
procedure.
12) Restart perfusion.
I. MEDICAL DEVICES FOR USE WITH THE
CARDIOPLEGIA SETS
Temperature monitoring must be by means of a SORIN GROUP ITALIA code 9026
or Y.S.I. series 400 compatible probe.
There are no contraindications for the use of any heating/cooling system
(thermocirculator), except that the water connections must be the SORIN GROUP
ITALIA code 9028 Hansen type.
To the best of SORIN GROUP ITALIA's current knowledge, there are no
contraindications to the use of the device with roller pumps.
The use of other types of pump must be agreed with SORIN GROUP ITALIA.
Incorrect occlusion setting or incorrect use of the pump are not covered by the tube
quality guarantee, since these are variables which cannot be controlled by SORIN
GROUP ITALIA.
J. 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
14401 West 65th Way
Arvada, CO 80004-3599
FAX (800) 323 4031
K. 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 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 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).
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