Blood Recovery After Bypass; Oxygenator Replacement - SORIN GROUP D901 LILLIPUT 1 Mode D'emploi

6) Increase arterial flow to 200 ml/min.
- If extracorporeal circulation has to be restarted subsequently, a minimum
blood flow inside the D901 LILLIPUT 1 OPEN SYSTEM must be maintained
(maximum 200 ml/min).
- If the use of the haemofilter is necessary, refer to its specific instructions for
use.
Absolutely avoid the emptying of the hardshell Venous Reservoir.
J. BLOOD RECOVERY AFTER BYPASS
1) Recover into the Venous Reservoir as much blood as possible from the venous
line, as soon as the surgeon has removed the cannulae from the patient's vena
cava.
2) Deliver blood into the aortic cannulae as required by the patient's condition,
slowly decreasing the level in the Venous Reservoir.
3) When the reservoir is nearly empty stop the arterial pump and clamp the arterial
line.
4) If necessary, empty the Cardiotomy Reservoir through pos lock connector and
dedicated adapter included in the LILLIPUT 1 OPEN SYSTEM packaging.
K. USE OF CARDIOTOMY RESERVOIR FOR POST-
OPERATIVE DRAINAGE
If the use of the Cardiotomy Reservoir for post-operative drainage is envisaged, act
as follows:
1. Clamp the purging/recirculation line.
2. Disconnect the purging/recirculation line and close the connection with a luer
cap.
3. Separate the venous reservoir from the oxygenating module by rotating the
white hook.
4. Locate the Venous Reservoir on its own holder.
L. OXYGENATOR REPLACEMENT
A spare oxygenator must always be available during perfusion. After 6 hours of use
with blood or if particular situations occur, which may lead the person responsible for
perfusion to determine that the safety of the patient may be compromised,
(insufficient oxygenator performance, leaks, abnormal blood parameters etc.),
proceed as follows for oxygenator replacement.
Use sterile methods during all replacement procedure.
1) Turn the gas flow off
2) Close, by means of a double clamp, the venous line (5 centimetres 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 reconnection.
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).
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" vertical 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 arterial line to one of the 3/16"
inlet connectors of the new reservoir.
M. MEDICAL DEVICES FOR USE WITH THE D901
LILLIPUT 1 OPEN SYSTEM
All tubing used to make the circuit connections must be of a diameter 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 ITALIA probes,
6
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, provided 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 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.
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 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
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 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
GB - ENGLISH