Intended Use; Contraindications; Safety Information - sorin Xtra Instructions D'utilisation

CATALOGUE N. PRODUCT DESIGNATION
04254 Procedure Set TX/55
04255 Procedure Set TX/125
04256 Procedure Set TX/175
04257 Procedure Set TX/225
04261 Procedure Set BX/55
04262 Procedure Set BX/125
04263 Procedure Set BX/175
04264 Procedure Set BX/225
04278 Procedure Set BX/225 - 120µm
All these devices are single use, non toxic, non pyrogenic, supplied STERILE and
packaged singly. Sterilized by ethylene oxide. The level of ethylene oxide residuals in
the device is within the limits established by national regulations in the country of use.

INTENDED USE

The intended use for the XRES Blood Collection Reservoir, Collection Set Cardio and
Collection Set are respectively:
XRES Blood Collection Reservoir
The XRES Blood Collection Reservoir is an accessory to an autotransfusion device
and is intended for the sterile collection and filtration of recovered blood for
subsequent processing for autotransfusion.
Collection Set Cardio
The Collection Set Cardio is intended for intra and postoperative sterile recovery and
filtration of the bloodshed in cardiovascular operations. It is to be used in combination
with the aspiration line and with the vacuum line that are included in the set.
The Collection Set Cardio is provided with the Cardio Kit, which includes a set of
adapters for connection of the extra-corporeal circulation (ECC) circuit to the Bowl Set
of the XTRA Autotransfusion System or to the XRES Blood Collection Reservoir. The
adapters contained in the Cardio Kit allow to extend the use of the autotransfusion
techniques to the following procedures:
 Concentration of priming fluid during ECC
Recovery of priming fluid residue from the ECC circuit

Collection Set
The Collection Set is intended for intra and postoperative sterile recovery and filtration
of the bloodshed in non-cardiovascular operations. It is to be used in combination
with the AAL Aspiration and Anticoagulation Line and with the VEL Vacuum Extension
Line that are included in the set.
The products listed above should be used in combination with medical devices listed
in section "Medical devices to be used with the products''.

CONTRAINDICATIONS

There are no known contraindications for this product. However, the use of blood from
this device for reinfusion may be contraindicated, e.g., in the presence of certain
potentially harmful substances (refer to cell separator manual for more detail). The
responsibility for the use of the device in all cases belongs solely to the physician in
charge.

SAFETY INFORMATION

Information intended to attract the attention of the user to potentially dangerous
situations and to ensure correct and safe use of the device is indicated in the text in
the following way:
Indicates serious adverse reactions and potential safety hazards for practitioner
and/or patient that can occur in the proper use or misuse of the device, and also
the limitations of use and the measures to be adopted in such cases.
CONTENT
XTRA Bowl Set X/55 and Collection Set TX
Cardio
XTRA Bowl Set X/125 and Collection Set TX
Cardio
XTRA Bowl Set X/175 and Collection Set TX
Cardio
XTRA Bowl Set X/225 and Collection Set TX
Cardio
XTRA Bowl Set X/55 and Collection Set BX
XTRA Bowl Set X/125 and Collection Set BX
XTRA Bowl Set X/175 and Collection Set BX
XTRA Bowl Set X/225 and Collection Set BX
XTRA Bowl Set X/225 and Collection Set BX with
120µm filter
Indicates any special care to be exercised by a practitioner for the safe and
effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
PRODUCT DESCRIPTION
SAME AS COLLECTION SET TOP CARDIO, PLUS
BOWL SET WITH 55ML BOWL
SAME AS COLLECTION SET TOP CARDIO, PLUS
BOWL SET WITH 125ML BOWL
SAME AS COLLECTION SET TOP CARDIO, PLUS
BOWL SET WITH 175ML BOWL
SAME AS COLLECTION SET TOP CARDIO, PLUS
BOWL SET WITH 225ML BOWL
SAME AS COLLECTION SET BOTTOM, PLUS
BOWL SET WITH 55ML BOWL
SAME AS COLLECTION SET BOTTOM, PLUS
BOWL SET WITH 125ML BOWL
SAME AS COLLECTION SET BOTTOM, PLUS
BOWL SET WITH 175ML BOWL
SAME AS COLLECTION SET BOTTOM, PLUS
BOWL SET WITH 225ML BOWL
SAME AS COLLECTION SET BOTTOM WITH 120µm
FILTER, PLUS BOWL SET WITH 225ML BOWL
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
Manufactured by
Sterile - Ethylene oxide sterilized
Non Pyrogenic
Contains PHTHALATE
Latex free
CAUTION: Federal law (USA) restrict this device to
sale by or on the order of a physician
Warning: Do not resterilize.
Contents sterile only if package is not opened,
damaged or broken
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
Keep dry
ea Quantity