Medical Devices For Use With Micro; Return Of Used Products; Limited Warranty - sorin Micro Mode D'emploi

- Start the pump and adjust flow to less than 100 ml/min. Continue
until the filter is completely full.
- Close stopcock on the purge line and immediately stop the pump .
See figure 3
- Remove line clamps at the outlet (D) and inlet (A) Clamp by-pass
line (C).
- Start the pump .
- Open stopcock on the purge line.
- Increase the flow up to 2 l/min
- Close stopcock on the purge line and stop the pump .
- Gently tap the filter to remove any microbubbles.
See figure 4
- Remove the filter from the holder, turn it upside down and gently
tap the filter to remove any microbubbles from the filtering
element.
- Start the pump at 2 l/min gently tap the filter.
- Stop the pump .
- See figure 5
- Set the filter upright again.
- Start the pump and adjust flow at about 2 ml/min. Open filter purge
port and gently tap the body to remove any residual bubbles.
- Filter is correctly primed when the outflow and the filtering element
are completely free of bubbles.
G. MEDICAL DEVICES FOR USE WITH MICRO
There are no contraindications for the use of MICRO filter with any
oxygenation system and cardiopulmonary bypass if the following
conditions apply (ref. paragraph B - TECHNICAL FEATURES):
- For filter connection use tube diameters compatible with device
connector sizes;
- Y connectors should be of any type, provided that their diameter is
compatible with the dimensions of connecting lines;
- During perfusion, comply with limitations to the maximum blood
flow (l/min) required for each version.
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.
H. 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.
I. 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.
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
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