Inhaltsverzeichnis; Technical Features; Intended Use; Safety Information - dideco D 902 LILLIPUT 2 ECMO Gebrauchsanweisung

GB - ENGLISH
I. 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 D 902 LILLIPUT 2 ECMO
M. Limited Warranty
A. DESCRIPTION
The D 902 LILLIPUT 2 ECMO is a hollow fibre membrane oxygenator
with a heat exchanger integrated into the oxygenating module.
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 maximum blood flow
−
Membrane type
−
Membrane surface area
−
Heat exchanger surface area
−
Static priming volume
(oxygenating module + heat exchanger)
−
Connections:
Oxygenating module venous inlet1/4"-5/16" (6,35-7,94 mm)
Oxygenating module arterial outlet
C. INTENDED USE
The D 902 LILLIPUT 2 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 D 902 LILLIPUT 2 ECMO is an INFANT oxygenator intended for use
in procedures on patients with a body weight of less than 20 Kg (44 lb.).
The D 902 LILLIPUT 2 ECMO should not be used longer than 5 days.
Contact with blood for longer periods is not advised.
The device should be used in combination with medical devices listed in
section L (Medical devices for use with the D 902 LILLIPUT 2 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 the
safe and effective use of the device.
GB - ENGLISH - INSTRUCTIONS FOR USE
2300 ml/min
Polymethilpentene
0.67 Sqm
0.02 Sqm
90 ml
1/4"-5/16"
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
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 only be used if STERILE. In the event of
the device being supplied NOT STERILE (this is indicated
by the symbol non sterile on the pack) contact Sorin Group
Italia or an authorised dealer to agree on a sterilisation
method.
•
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 apply 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
weighed against the benefits of extracorporeal support
when this device is considered.
GB - ENGLISH
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
Sterile - Ethylene oxide sterilised
Non Pyrogenic
Non sterile
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
Temperature limitation
0°C (32°F)÷ 60°C (140°F)
Keep dry
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