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Idiomas disponibles
Idiomas disponibles
I. CONTENTS
I. Contents
A. Description
H. Operation during bypass
A. DESCRIPTION
The D905 EOS ECMO is a 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.
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Static priming volume (recovered)
(oxygenating module + heat exchanger)
- Connections:
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The D905 EOS ECMO is intended for use in an extracoporeal circuit
as a device to replace the function of the lungs (transfer of oxygen
and removal of carbon dioxide) in order to control the arterial/venous
temperature during extended respiratory support applications (i.e.
ECMO).
The blood to be treated should contain anticoagulant.
The D905 EOS ECMO should not be used longer than 5 days.
Contact with blood for longer periods is not advised.
The D905 EOS ECMO should be used in combination with medical
devices listed in section L (Medical devices for use with the D905
EOS ECMO).
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
GB - ENGLISH - INSTRUCTIONS FOR USE
5000 ml/min
Polymethylpentene
1.2 m
0.14 m
150 ml
3/8" (9.53 mm)
GB - ENGLISH - INSTRUCTIONS FOR USE
the safe and effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
2
2
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.
- Do not expose to temperatures below 0°C (32°F) or above
60°C (140°F).
- 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. The risk of total systemic anticoagulation must be
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
Warning: Do not resterilize.
Contents sterile only if package is not
opened, damaged or broken
Catalogue (code) number
Attention, see instruction for use
ea
Quantity
This way up
Fragile; handle with care
Keep away from heat
Keep dry
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