Gb - English - Instructions For Use; Technical Features; Intended Use; Safety Information - SORIN GROUP D905 EOS Instrucciones Para El Uso

GB - ENGLISH
CONTENTS
I. Contents
A. Description
B. Technical features
C. Intended use
D. Safety information
E. Set up
F. Priming and recirculation procedure
G. Initiating bypass
H. Operation during bypass
I. Terminating bypass
J. Blood recovery after bypass
K. Oxygenator replacement
L. Medical devices for use with the D905 EOS MODULE
M. Return of used products
N. Limited Warranty
A. DESCRIPTION
The D905 EOS MODULE is a microporous hollow fibre membrane oxygenator
composed of a gas exchange module connected with a heat exchanger.
The device is single use, non-toxic, non pyrogenic, supplied STERILE and packaged
singly. Sterilised 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.
The device is available in the following version:
[A] D 905 EOS MODULE
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Recovered priming volume
(oxygenating module + heat exchanger)
- Connections:
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The D905 EOS MODULE is intended for use in cardiopulmonary bypass circuits as
a device to replace the function of the lungs (transfer of oxygen and removal of
carbon dioxide) and in order to control the arterial/venous temperature.
The blood to be treated should contain anticoagulant.
The D905 EOS MODULE should not be used longer than 6 hours. Contact with
blood for longer periods is not advised.
The D905 EOS MODULE should be used in combination with medical devices listed
in section L (Medical devices for use with the D905 EOS MODULE).
D. 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

GB - ENGLISH - INSTRUCTIONS FOR USE

5000 ml/min
Microporous Polypropylene
1.1 m
2
0.14 m
2
160 ml
3/8" (9.53 mm)
3/8"
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.
- SORIN GROUP ITALIA is not responsible for problems arising from
inexperience or improper use.
- FRAGILE, handle with care.
- Keep dry. Store at room temperature.
- 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 after use.
Therefore, 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 contains phthalates. Considering the nature of contact with the
body, the limited duration of contact and the number of treatments per
patient, the amount of phthalates which might be released from the device
does not raise specific concerns about residual risks. Further information is
available on request from Sorin Group Italia
- Always give and maintain a correct dose and accurate monitoring of the
anticoagulant before, during and after the bypass.
- The device must not undergo any further processing.
- Do not resterilise.
- 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.
- For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
E. SET UP
1) POSITION THE HOLDER
Position the EOS MODULE D627 holder on the pump structure by means of
the clamp at the upper end of the extension arm (fig. 1, ref. 1).
2) FIX THE OXYGENATOR TO THE HOLDER
- Sterility is guaranteed only if the sterile packaging is not wet,
GB - ENGLISH
Non Pyrogenic
Contains PHTHALATE
Latex free
Warning: Do not resterilize.
Contents sterile only if package is not opened,
damaged or broken
Catalogue (code) number
Attention, see instruction for use
Attention, see instruction for use
This way up
Fragile; handle with care
Quantity
Keep away from heat
Keep dry
3