sorin Xtra Instructions D'utilisation page 5

The following is general safety information with the aim of advising the operator in
preparing to use the device. Also, specific safety information is given in the
instructions for use at locations in the text where that information is relevant for correct
operation.
 The device must be used in accordance with the instructions for use
provided in this manual.
The device is intended to be used by professionally trained personnel.

 Do not use the device if it has been cracked, dropped or otherwise
physically damaged.
SORIN GROUP ITALIA is not responsible for problems arising from

inexperience or improper use.
FRAGILE, handle with care.

Avoid any condition which may cause the blood temperature to exceed

37°C (98.6°F).
 Keep dry. Store at room temperature.
Always apply and maintain a correct dose and accurate monitoring of the

anticoagulant.
 For single use and for single patient use only: during use the device is in
contact with human blood, body fluids, liquids or gases for the purpose of
eventual infusion, administration or introduction into the body and due to
its specific design it cannot be fully cleaned and disinfected at the end of
use. Therefore the reuse on other patients might cause cross-
contamination, infection and sepsis. In addition, the reuse increases the
probability of product failure (integrity, functionality and clinical
effectiveness).
The device must not undergo any further processing.

Do not resterilize.

After use, dispose of the device in accordance with applicable regulations

in force in the country of use.
The device must only be used if STERILE.

The device contains phthalates. Considering the nature of body contact,

the limited contact duration and the number of treatments per each patient;
the amount of phthalates which might be released from the device do not
raise specific concerns about residual risks. Further information is
available on request from Sorin Group Italia.
 For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorized local representative.
 For a detailed description of the circuits, refer to the user's manual of the
SORIN GROUP ITALIA cell separator
Refer to the cell separator user's manual for complete instructions on use

of the device
Federal law (U.S.A.) restricts this device to sale by or on the order of a

physician
SET UP
A XRES Blood Collection Reservoir can be mounted on the integrated holder present
on XTRA Autotransfusion System or on an IV pole
HOLDER SET UP
Integrated reservoir holder
 Swing open the reservoir holder and raise it to the desired height.
DISPOSABLE SET UP
 Sterility is guaranteed only if the sterile packaging is not wet, opened,
damaged or broken. Do not use the device if sterility cannot be guaranteed.
 Check the expiry date on the label attached. Do not use the device after the
date shown.
 The device must be used immediately after opening the sterile packaging.
The device must be handled aseptically.

 Carry out a visual inspection and carefully check the device before use.
Transport and/or storage conditions other than those prescribed may have
caused damage to the device.
Do not use solvents such as alcohol, ether, acetone, etc. to prevent

damage to the device.
Make the connections using a suitable aseptic technique.

 Due to the possibility of operator exposure to bloodborne pathogens (such
as HIV, hepatitis viruses, bacteria, Cytomegalovirus, etc.) when handling
extracorporeal blood circuits, adequate precautions should be taken at all
times to prevent the exposure to and transmission of such agents.
 Carefully observe this set for leaks before and during use. Leakage may
result in loss of sterility or loss of blood and/or fluid. If leakage is observed
before or during use, replace leaking component or retighten leaking
connection, as appropriate.
Set up of the XRES Blood Collection Reservoir
The setup of the Blood Collection Reservoir can be performed inserting it into the
integrated holder.
1. Remove the reservoir from its package.
2. Keep the locking clip on the reservoir holder open, slide the edge of the reservoir
lid into the slot of the holder and push the reservoir into position. Release the
locking clip.
3. Tighten all the caps and luer locks on the reservoir lid. In case you are using a
Blood Collection Reservoir BOTTOM, close the clamp on the bottom outlet port.
Before use, check that the blood collection reservoir is completely inserted

in its housing on the holder. In the event of incorrect installation, any
accidental knocks against the reservoir might cause it to detach from the
holder
Set up of the AAL Aspiration and Anticoagulation Line
1. Raise the IV pole completely.
2. Prepare a bag or bottle of anticoagulant solution containing heparin, ACD-A or
CPDA-1. If heparin is used, mix 30.000-60.000 I.U. of heparin per liter of sterile
(injectable) isotonic saline to guarantee sufficient anticoagulation of recovered
blood.
3. Remove the aspiration and anticoagulation line from its package and carefully
open the outer wrap.
4. Pass the inner sterile wrapped assembly to the sterile field.
5. At the sterile field, unwrap the assembly, remove the protective cover, and
attach the connector to a suction cannula.
6. Pass the other end (the split end) of the aspiration line back from the sterile field
to the XTRA Autotransfusion System operator.
7. Close the roller clamp on the small bore tubing.
8. Remove the protective cover on the large bore tubing of the aspiration and
anticoagulation line.
9. Attach the tubing to one of the inlet ports on the lid of the reservoir. The inlet
ports are 45° angled, orange-capped, marked SUCTION.
10. Hang the anticoagulant solution container on one of the holders of the IV pole.
11. Using aseptic technique, spike the container of the anticoagulant solution.
Set up of the VEL Vacuum Extension Line
1. Attach one end of the vacuum line to the XVAC Vacuum System (or another
vacuum source)
2. Attach the other end to the vacuum port (yellow capped, marked VACUUM) on
the lid of the XRES Blood Collection Reservoir.
Set up of the Cardio Kit (for Collection Set Cardio only, otherwise skip next
steps)
Connecting the Y adapter to the XRES Blood Collection Reservoir
1. Close the clamps on the Y adapter branches waiting for subsequent
connections.
NOTE: The branch ending with a male port is used to connect the
reservoir to the Bowl Set, the branch ending with a female port is used to
connect the XRES Blood Collection reservoir to a circuit or oxygenator for
ECC through the Oxygenator Extension Line.
2. Connect the Y adapter ¼'' port to the reservoir outlet port:
A.
B.
Connecting the Oxygenator Extension Line to a circuit or oxygenator for
ECC
1. Before adding the priming liquid to the ECC circuit, connect the 1/4"
Adapter Tubing contained in the Cardio Kit to a 1/4" connector of the
circuit or oxygenator for ECC.
2. Close the ¼'' Adapter Tubing with a clamp, keeping the protective cap in
place to maintain sterility. During priming circulation remove the air from
the circuit.
3. Connect one end of the Oxygenator Extension Line to the free end of the
¼'' Adapter Tubing
4. Connect the other end to the female connector on the Y Adapter branch or
directly to the Bowl Set.
INSTRUCTIONS FOR USE
Blood collection and anticoagulation
1. Switch on the vacuum system, following below instructions according to the
system used
a) If using XVAC vacuum system linked to XTRA Autotransfusion System:
a.1.
a.2.
a.3.
NOTE:

GB – ENGLISH
located on the reservoir lid, marked WASH and covered with a
blue cap on the XRES T Blood Collection Reservoir
located on the bottom of the XRES B Blood Collection Reservoir
with the blue cap
Make sure XVAC is connected to the XTRA and the power switch
on the back of the vacuum unit is on ON.
Turn on the XTRA Autotransfusion System and wait for system's
boot up
Regulate the vacuum level from the vacuum displet present on the
cell separator's screen
Once system's boot up is finished, the level of vacuum is controlled
from the vacuum displet present on the cell separator's screen
5