Return Of Used Products - sorin Xtra Serie Instrucciones De Uso

a. If not transfused immediately, units collected and processed under
sterile conditions with a device for intraoperative blood collection
that washes with 0.9% saline, USP, shall be stored under one of the
following conditions prior to completion of transfusion:
At room temperature for up to 4 hours after completion of

processing
at 1 °C to 6 °C for up to 24 hours, provided that storage at 1°C

to 6 °C is begun within 4 hours after completion of processing
b. The transfusion of shed blood collected under postoperative or
posttraumatic conditions shall be completed within 6 hours of
initiating the collection.
American Association of Blood Banks. Standards for Perioperative
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Autologous Blood Collection and Administration. 3
MD: American Association of Blood Banks, 2007.
Using XRES Blood Collection Reservoir Quick Reinfusion Port
XRES T Blood Collection Reservoir
The XRES T Blood Collection Reservoir is provided with a pierceable port on the
bottom, to gravity drain blood out of the reservoir. This port can be accessed with a
spike connector and may be used to empty the reservoir in case needed, or to
quickly reinfuse the unprocessed salvaged blood to the patient, in emergency
situations.
Observe the following instructions to access the Quick Reinfusion Port:
1. Shut off the vacuum source, pull the yellow tab on the vacuum port of the
reservoir lid, then raise the reservoir as high as needed
2. Insert a spike through the integral membrane
3. In case of quick reinfusion, completely prime the line before connection to
the patient
XRES B Blood Collection Reservoir
The XRES B Blood Collection Reservoir is provided with a ¼'' male outlet port on the
bottom, to gravity drain blood out of the reservoir. This port may be used to empty the
reservoir in case needed, or to quickly reinfuse the unprocessed salvaged blood to the
patient, in emergency situations.
Observe the following instructions to use the bottom outlet port as a Quick Reinfusion
Port:
1. Shut off the vacuum source, pull the yellow tab on the vacuum port of the
reservoir lid, then raise the reservoir as high as needed
2. Connect an infusion line to the ¼'' bottom outlet port male connector,
using an adapter if needed
3. In case of quick reinfusion, completely prime the line before connection to
the patient
4. Open the clamp on the bottom outlet port to reinfuse
 Limit the reinfusion of unprocessed blood to the surgical situations of real
necessity. The decision and responsibility of reinfusing unprocessed
blood belongs solely to the physician in charge. When reinfusing
unprocessed blood, the use of a microaggregate filter on the patient
reinfusion line is mandatory.
MEDICAL DEVICES TO BE USED WITH THE
PRODUCTS
 The XRES Blood Collection Reservoir, Collection Set Cardio and Collection Set
must be connected to the Sorin group Italia Bowl Sets for removal of undesired
substances collected from the surgical field.
 The connections to the product must be of a diameter which is compatible with
the dimensions of the connectors on the device (3/8" or 1/4").
The aspiration must be performed with SORIN GROUP ITALIA surgical

aspirator or other aspirators having compatible technical characteristics.
The User should observe the warnings and cautions and follow Instruction

for Use accompanying the separate device.

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
authorization (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
ed. Bethesda,
rd
properly labeled 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).
GB – ENGLISH
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