Medical Devices For Use With The D 901 Lilliput 1 Open; Open System; Return Of Used Products; Limited Warranty - dideco D 901 LILLIPUT 1 Instrucciones De Uso

2) Close, by means of a double clamp, the venous line (5 centime-
tres apart).
3) Turn the arterial pump off and close, by means of a double clamp,
the arterial line (5 centimetres apart) placed next to the oxygenator.
4) Turn the thermocirculator off, clamp and remove the water lines.
5) Disconnect the gas line, all monitoring and sampling lines.
6) Cut the venous return and the arterial lines in the section between
the two clamps, leaving a sufficient length of tubing to allow re-
connection.
7) Remove the D 901 LILLIPUT 1 OPEN SYSTEM from the holder
(according to the appropriate instructions for use) and remove
the pump segment from the arterial pump.
8) Place a new D 901 LILLIPUT 1 OPEN SYSTEM on the holder.
Connect all lines (i.e. venous to the Venous Reservoir, arterial
and gas to the oxygenator, pump line to Venous Reservoir and
oxygenator).
WARNING
In this phase, keep the venous and arterial lines clamped.
9) Open the water lines on the holder, turn the thermocirculator on
and check the integrity of the new D 901 LILLIPUT 1 OPEN
SYSTEM.
10) Fill the cardiotomy reservoir of the new D 901 LILLIPUT 1 OPEN
SYSTEM with priming solution through the 3/16" or 1/4" verti-
cal filtered quick prime connector located on the head of the
cardiotomy reservoir.
11) Prime the new D 901 LILLIPUT 1 OPEN SYSTEM and evacuate
the microbubbles, as described in the priming and recirculation
procedure.
12) Verify all connections and secure with ties.
13) Remove clamps from the venous and the arterial line, close the
purging/recirculation line and start the bypass again.
14) The blood remaining in the replaced Venous Reservoir may be
recovered by connecting its outlet port to one of the 3/16" inlet
connectors of the new reservoir.
15) The blood contained in the oxygenator and heat exchanger may
be poured into the new Venous Reservoir by connecting the arte-
rial line to one of the 3/16" inlet connectors of the new reservoir.
M. MEDICAL DEVICES FOR USE WITH THE D 901 LILLIPUT

1 OPEN SYSTEM

All tubing used to make the circuit connections must be of a diame-
ter which is compatible with the dimensions of the connectors on
the device (3/16" or 1/4").
Temperature controls must be carried out using SORIN GROUP ITA-
LIA 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, provi-
ded 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 contraindica-
tions to the use of the device with occlusive or non-occlusive peri-
staltic pumps or with centrifugal pumps. The use of other types of
pump must be agreed with SORIN GROUP ITALIA.
N. 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 informa-
tion 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 under-
stand 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 legi-
slation in force in the country where the product was used.

CAUTION

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 pre-
vent 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
O. 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 effective-
ness 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 stric-
tly to the instructions for use and to adopt all the precautions neces-
sary for the correct use of the device, cannot assume any responsi-
bility for any loss, damage, expense, incidents or consequences ari-
sing 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 pur-
pose.
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 sta-
ted 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 litiga-
tion with SORIN GROUP ITALIA, not to make claims based on alle-
ged or proven changes or alterations made to this Limited Warranty
by any representative, agent, dealer, distributor or other interme-
diary.
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 jurisdic-
tion. The court chosen is the Court of Modena (Italy).
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