sorin APEX HP M Instrucciones De Uso página 8

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 it to the arterial temperature probe fitting of the new
oxygenator.
20. Remove the gas scavenging line from the old oxygenator and
connect it 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:
¾ Detailed description of the event and, if pertinent, the conditions of
the patient;
¾ Identification of the product involved;
¾ Lot number of the product involved;
¾ Availability of the product involved;
¾ 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 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 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.
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
8
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 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
Patient Size
Maximun Blood Flow
Maximun Gas Flow
Priming Volume
Unit Size
Height 8.75" (22 cm)
Width (with ports)
Weight 2.0 lbs (908 gm)
Ports
Oxygenator Inlet Port
Oxygenator Outlet Port
Arterial Blood Access Port
Arterial Sampling Port
Fittings
Gas Inlet Fitting
Water Inlet & Outlet Fittings
Arterial Temperature Probe
Anesthetic Gas Scavenge
Heat Exchanger
Material
Surface Area
Membrane
Configuration
Membrane Surface Area
Membrane Material
Pressure Limitations
Blood Pathway
Gas Pathway
Water Pathway
Blood Access Connector
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
GB – ENGLISH
UNIT SPECIFICATIONS
®
HP M AND APEX HP M PH.I.S.I.O.
HOLLOW-FIBER MEMBRANE
BLOOD OXYGENATOR
OPERATING PARAMETERS
Adult
8 liters/min
16 liters/min
250 ml
6.5" (16.5 cm)
3/8" (9.5 mm)
3/8" (9.5 mm)
pos-lock
Female Luer-lock
1/4" (6.4 mm)
Hansen 3ST
YSI Series 400
3/8" (9.5 mm)
Stainless Steel
2
0.14 m
Hollow Fiber
(Blood outside fiber)
2
1.87 m
Microporous Polypropylene
750 mmHg (100 kPa)
0 mmHg at outlet
44 psi (300 kPa)
1/4" (6.4 mm) Barb
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)