Table Des Matières; Description; Technical Features; Intended Use - SORIN GROUP D902 LILLIPUT 2 Mode D'emploi

GB - ENGLISH
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
M. Return of used products
N Limited Warranty
A. DESCRIPTION
The D 902 LILLIPUT 2 is a microporous 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. The device is available in the following
versions:
[A] D 902 LILLIPUT 2 (oxygenating module, soft venous reservoir and 4-way
sampling manifold and haemofilter)
[B] D 902 LILLIPUT 2 (oxygenating module, soft venous reservoir and 4-way
sampling manifold)
[C] D 902 LILLIPUT 2 (oxygenating module)
[D] D 902 LILLIPUT 2 (oxygenating module, rigid venous reservoir and 4-way
sampling manifold)
B. TECHNICAL FEATURES
- Recommended maximum blood flow
- Reference blood flow
(AAMI Standard)
- Membrane type Microporous
- Membrane surface area
- Heat exchanger surface area
- Soft venous reservoir volume
- Rigid venous reservoir volume
- Recovered 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 902 LILLIPUT 2 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) in order to control the arterial/venous temperature and as a venous blood
reservoir. The blood to be treated should contain anticoagulant. The D 902 LILLIPUT 2
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 should not be used longer than 6
hours. 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).
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)
GB - ENGLISH - INSTRUCTIONS FOR USE
2300 ml/min
3300 ml/min
polypropylene
0.64 Sqm
0.02 Sqm
min 40 ml
max 190 ml
max 1800 ml
105 ml
3/8" (9,53 mm)
1/4" (6,35 mm)
1/4"-5/16" (6,35-7,94 mm)
1/4"-5/16"
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.
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 apply 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.
GB - ENGLISH
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 instructions for use
This way up
Fragile; handle with care
Quantity
Keep away from heat
Keep dry
3