SORIN GROUP WR4000I Instrucciones De Uso página 7

7. Transfer the cardiotomy suction lines, recirculation line, vent lines, arterial
filter purge, etc. from the old venous reservoir to the new venous reservoir.
Check that all the connections are secure.
8. Unclamp the recirculation line. Ensure that there is still a clamp on the
arterial line to the patient.
9. Start the arterial pump slowly and transfer the blood from the old venous
reservoir to the new venous reservoir through the recirculation line.
Continue until all the blood has been removed from the old venous
reservoir, but do not empty the line coming out of the venous reservoir.
Turn off the pump.
10. Place two clamps on the old venous reservoir outlet line near the reservoir
outlet and approximately 1.5 inches (3.8 cm) apart. Using an aseptic
technique, cut between the clamps, near the clamp closest to the outlet.
11. Attach the reservoir outlet line to the 3/8" (9.5 mm) straight connector on
the outlet of the new venous reservoir.
12. Remove the venous line from the old reservoir and attach it to the new
venous reservoir. Where applicable, remove and reattach the left
ventricular vent line, priming lines, and arterial filter purge line.
13. Remove the clamp from the outlet line of the new venous reservoir.
14. Check that all the connections are secure. Ensure that there is still a clamp
on the arterial line on the patient side of the recirculation line.
15. Remove the clamps from the venous and arterial lines and reinitiate bypass
according to normal procedures.
16. Transfer the temperature probe from the venous inlet of the old venous
reservoir to the venous inlet of the new venous reservoir (if applicable).
17. Transfer the SAT/HCT probe from the SAT/HCT fitting of the old venous
reservoir to the SAT/HCT fitting of the new venous reservoir (if applicable).
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 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 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
box or an equivalent box 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.
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.
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.
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 correct use of
the device, cannot assume any responsibility for any loss, damage, expense,
incidents or consequences arising directly or indirectly from 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 any 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 with 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).
UNIT SPECIFICATIONS
VVR 4000i and VVR4000i SMARxT
SEALED HARDSHELL VENOUS RESERVOIR
with INTEGRAL CARDIOTOMY FILTER
VVR 4000i Sealed Filtered Venous Reservoir
Maximum Flow
Maximum Cardiotomy Flow
Minimum Operating Volume
Maximum Volume Capacity
Max. negative reservoir pressure
System Size
Height
Maximum Diameter
Weight
Ports
Defoamed and Unfiltered:
Venous Inlet Port
Rapid Prime Port
Recirculation Port
Filter Bypass Port
Female Luer Lock
Venous Sampling Port
Defoamed and Filtered:
Cardiotomy Ports (5)
Cardiotomy Luer-lock Port
Other:
Venous Reservoir Outlet Port
Vent/Vacuum Port
Pressure Valve
GB – ENGLISH
8 liters/min (combined venous &
cardiotomy flow)
4 liters/min
100 ml up to 5 liters/min
200 ml for 5 to 8 liters/min
4000 ml
-90 mmHg
33 cm
21 cm
1 kg
1/2 in (12.7 mm)
1/4 in (6.4 mm)
1/4 in (6.4 mm)
3/8 in (9.5 mm)
3
Female Luer Lock
Four 1/4 in (6.4 mm) One 3/8
in (9.5 mm)
2
3/8 in (9.5 mm)
1/4 in (6.4 mm)
Integral
7