Safety Information - sorin Xtra Instructions D'utilisation

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.
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
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 sterilised
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
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
4
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 litre 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.
GB – ENGLISH