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Idiomas disponibles
Idiomas disponibles
GB - ENGLISH
CONTENTS
H. Operation during bypass
I.
L.
Use of cardiotomy for post-operative autotransfusion
M. Oxygenator replacement
A. DESCRIPTION
The D 905 EOS is a microporous hollow fibre membrane oxygenator consisting of a gas
exchange module with an integrated heat exchanger and a Hardshell Reservoir.
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.
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
- Recoverd priming volume
(oxygenating module + heat exchanger)
- Connections:
Venous reservoir return
Venous reservoir outlet
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The D 905 EOS is intended for use in pediatric / small adult surgical procedures
requiring extracorporeal gas exchange support and blood temperature control for
periods of up to 6 hours.
The D 905 EOS should be used in combination with medical devices listed in section M
(Medical devices for use with the D 905 EOS).
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:
WARNING 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.
CAUTION 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
GB - ENGLISH - INSTRUCTIONS FOR USE
5000 ml/min
Microporous Polypropylene
1.1 m
0.14 m
4300 ml
160 ml
1/2" (12.7 mm)
3/8" (9.53 mm)
3/8"
3/8"
2
2
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 User should carefully check the device during set-up and priming for
leaks.Do not use if any leak is detected.
- The device must be used in accordance with the instructions for use provided
in this manual.
- For use by professionally trained personnel only
- Sorin Group Italia is not responsible for problems arising from inexperience or
improper use.
- FRAGILE, handle with care.
- Keep dry. Store at room temperature.
- Always give and maintain a correct dose and accurate monitoring of the
anticoagulant before, during and after the bypass.
- 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
- 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.
- For further information and/or in case of complaint contact SORIN GROUP
ITALIA or the authorised local representative.
- Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
E. SET UP
1) POSITION THE HOLDER
Position the D 905 EOS holder on the pump structure by means of the clamp at
the upper end of the arm (fig.1, ref. 1).
2) FIX THE OXYGENATOR TO THE HOLDER
GB - ENGLISH
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
5
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