GB - ENGLISH
2
GB - ENGLISH - INSTRUCTIONS FOR USE
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 D 902 LILLIPUT 2 ECMO
M. Return of used products
N. 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
2300 ml/min
Membrane type
Polymethilpentene
Membrane surface area
0.67 Sqm
Heat exchanger surface area
0.02 Sqm
Recovered priming volume
90 ml
(oxygenating heat exchanger)
Connections:
Oxygenating module venous inlet
1/4"-5/16”
(6.35-7.94 mm)
Oxygenating module arterial outlet
1/4"-5/16”
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.
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
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
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.
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.
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.
Technical complications during long-term use are generally
due to ineffective anticoagulation, wich reduces oxygenator
efficiency. Procedures lasting >6 houres should include
