Device Change-Out; Medical Devices For Use With Csc14; Return Of Used Products; Limited Warranty - SORIN GROUP CSC 14 Mode D'emploi

H. DEVICE CHANGE-OUT
A spare device must always be available during bypass in the
unlikely event that the device in use requires change-out.
Procedures lasting longer than 6 hours or particular situations
where the safety of the patient may be compromised
(insufficient performance, leaks, abnormal blood parameters,
etc.), could require change-out. Follow the steps below to
change out the device.
Use sterile methods during all replacement procedures.
1. While the patient is still on bypass, remove the new
CSC14 from its outer packaging and from the sterile
wrapper; inspect it for damage.
2. Turn off the thermocirculator, clamp the water lines
connected to the defective CSC14 and disconnect them.
Shut down the cardioplegia pumps.
3. Remove the defective CSC14 heat exchanger from its
holder and replace it with the new one.
4. Connect the water lines to the new CSC14 heat
exchanger and activate water recirculation. Check the
new CSC14 heat exchanger for leaks.
5. Remove the defective device from the circuit as follows:
- Remove the temperature probe.
- Clamp the purge line.
- Place 2 clamps (5 cm apart) on the inlet line.
- Place 2 clamps (5 cm apart) on the outlet line.
- Cut the inlet and outlet lines at the point between the two
clamps and connect them to the new CSC14 heat
exchanger.
6. Connect the temperature probe and the purge line of the
new CSC14 heat exchanger.
7. Open the inlet line and then prime and debubble the new
heat exchanger as described in paragraph F. PRIMING
PROCEDURE.
8. Restart perfusion.
Upon completion of this operation contact Sorin Group
Italia or its authorized representative to return the
potentially defective CSC14 for investigation.
I.

MEDICAL DEVICES FOR USE WITH CSC14

The user should observe the warnings and cautions and
follow the instructions for use accompanying the
separate device.
- HSC holder for CSC14 code 050137 .
- Temperature probe code 09026 (YSI 400 compatible)
To the best of Sorin Group Italia's current knowledge, there
are no contraindications for the use of the CSC14 unit with
occlusive and non-occlusive roller pumps, centrifugal pumps
and with any heater/coolers.
Any heating/cooling system (thermocirculator) may be used,
provided that the connectors to the device are of the Hansen
type (Sorin Group Italia code 09028).
Sorin Group Italia declares that CSC14 can be used with
supplementary equipment and disposable products as long
as they are expressly certified for use during cardiopulmonary
bypass.
J. 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 the 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 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 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
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