SORIN GROUP APEX Instrucciones Para El Uso página 7

port and approximately 1.5 inches (3.8 cm) apart. Using
aseptic technique, cut the line between the clamps. Cut near
the clamp closest to the oxygenator.
11. Attach the 3/8" (9.5 mm) oxygenator outlet line to the new
oxygenator outlet port.
12. Disconnect the arterial blood access line from the old
oxygenator and reconnect to the arterial blood access port on
the new oxygenator.
13. Remove the clamp on the oxygenator inlet line of the new
oxygenator.
14. Open the purge/recirculation valve to the purge position.
15. Check the security of all the connections. Ensure that there is
still a clamp on the arterial line to the patient.
16. Prime the new oxygenator and evacuate any air following the
priming and recirculation procedure.
17. Turn off the sample system. Turn off the arterial pump and
close the purge/recirculation valve.
18. Remove the clamps from the venous and arterial lines, and
reinitiate bypass according to normal procedures.
19. Remove the arterial temperature probe from the old
oxygenator and connect to the arterial temperature probe
fitting of the new oxygenator.
20. Remove the gas scavenging line from the old oxygenator and
connect to the new oxygenator.
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 good 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.
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. 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 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).
APEX
CATALOG NO. 050261000 and 050261700
Operating Parameters
Patient Size
Maximun Blood Flow
Maximun Gas Flow
Priming Volume
Static Priming Volume:
(post use recovered)
Unit Size
Height
Width (with ports)
Weight
Ports
Oxygenator Inlet Port
Oxygenator Outlet Port
Arterial Blood Access Port
Arterial Sampling Port
Fittings
Gas Inlet Fitting
Water Inlet & Outlet Fittings
GB – ENGLISH
UNIT SPECIFICATIONS
® ®
M and APEX M Ph.I.S.I.O.
HOLLOW FIBER MEMBRANE
BLOOD OXYGENATOR
Adult
8 liters/min
16 liters/min
310 ml
270 ml
8.75" (22 cm)
6.5" (16.5 cm)
2.0 lbs (908 gm)
3/8" (9.5 mm)
3/8" (9.5 mm)
pos-lock
Female luer lock
1/4" (6.4 mm)
Hansen 3ST
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