Product Description; Intended Use - sorin XRES T Instrucciones De Uso

GB – ENGLISH
GB – ENGLISH
CATALOGUE N. PRODUCT DESIGNATION
04258 XRES T Blood Collection Reservoir
04259 XRES B BLOOD COLLECTION
RESERVOIR
04260 Collection Set TX
04265 Collection Set BX
04266 Collection Set TX Cardio
04267 Collection Set BX Cardio
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 intended for intra and postoperative sterile
recovery and filtration of autologous blood.
Collection Set Cardio
The Collection Set Cardio is intended for intra and postoperative sterile recovery and
filtration of the blood shed 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
XRES BLOOD COLLECTION RESERVOIR AND
COLLECTION SET - INSTRUCTIONS FOR USE
CONTENT
Blood Collection Reservoir TOP
Blood Collection Reservoir BOTTOM
Blood Collection Reservoir TOP
Aspiration Line
Vacuum Line
Blood Collection Reservoir BOTTOM
Aspiration Line
Vacuum Line
Blood Collection Reservoir TOP
Aspiration Line
Vacuum Line
Cardio Kit
Blood Collection Reservoir BOTTOM
Aspiration Line
Vacuum Line
Cardio Kit
GB – ENGLISH

PRODUCT DESCRIPTION

HARD SHELL CONTAINER EQUIPPED WITH AN
INTEGRATED FILTER, TO COLLECT BLOOD
RECOVERED FROM THE FIELD REMOVING
AGGREGATES LARGER THAN 40 µM DIAMETER.
IN THE TOP OUTLET VERSION, THE OUTLET
PORT IS LOCATED ON THE LID OF THE DEVICE
HARD SHELL CONTAINER EQUIPPED WITH AN
INTEGRATED FILTER, TO COLLECT BLOOD
RECOVERED FROM THE FIELD REMOVING
AGGREGATES LARGER THAN 40 µM DIAMETER.
IN THE BOTTOM OUTLET VERSION, THE OUTLET
PORT IS LOCATED ON THE BOTTOM OF THE
DEVICE
BLOOD COLLECTION RESERVOIR TOP PACKED
TOGETHER WITH THE ACCESSORY LINES
REQUIRED TO RECOVER BLOOD FROM THE
OPERATING FIELD.
THE ASPIRATION LINE ALLOWS TO TRANSFER
THE BLOOD ASPIRATED FROM THE OPERATING
FIELD TO THE RESERVOIR AND
CONTEMPORARILY ANTICOAGULATE IT
THE VACUUM LINE ALLOWS TO CONNECT THE
RESERVOIR TO THE VACUUM SOURCE
BLOOD COLLECTION RESERVOIR BOTTOM
PACKED TOGETHER WITH THE ACCESSORY
LINES REQUIRED TO RECOVER BLOOD FROM
THE OPERATING FIELD.
FOR ASPIRATION AND VACUUM LINES SEE
ABOVE FOR DESCRIPTION.
SAME AS THE COLLECTION SET TOP, PLUS AN
ADDITIONAL ACCESSORY KIT FOR CONNECTION
TO AN OXYGENATOR OR CIRCUIT FOR ECC
(CARDIO KIT)
THE CARDIO KIT CONTAINS:
1. Y ADAPTER
2. ¼ '' ADAPTER TUBING
3. OXYGENATOR EXTENSION LINE
4. LUER-LOCK ADAPTER
SAME AS THE COLLECTION SET BOTTOM, PLUS
AN ADDITIONAL ACCESSORY KIT FOR
CONNECTION TO AN OXYGENATOR OR CIRCUIT
FOR ECC (CARDIO KIT)
FOR CARDIO KIT SEE ABOVE FOR DESCRIPTION.
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 blood shed 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.
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