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Idiomas disponibles
Idiomas disponibles
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 D901 DIDECO LILLIPUT
M. Return of used products
N. Limited Warranty
A. DESCRIPTION
The D901 DIDECO LILLIPUT is a microporous hollow fibre membrane oxygenator
with a heat exchanger integrated into the oxygenating module. D901 DIDECO
LILLIPUT C Ph.I.S.I.O. and D901 DIDECO LILLIPUT M Ph.I.S.I.O. are coated with
Phosphorylcholine (Ph.I.S.I.O). Devices coated with Ph.I.S.I.O are used when a
coated blood path is desired. The Ph.I.S.I.O coating improves the blood compatibility
of the device by reducing platelet adhesion on the coated surfaces. 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 devi-ce
is available in the following versions:
[A] D 901 DIDECO LILLIPUT C (oxygenating module, soft venous reservoir
and 4-way sampling manifold)
[B] D 901 DIDECO LILLIPUT C Ph.I.S.I.O. (oxygenating module, soft
venous reservoir and 4-way sampling manifold)
[C] D 901 DIDECO LILLIPUT M (oxygenating module)
[D] D 901 DIDECO LILLIPUT M Ph.I.S.I.O. (oxygenating module)
B. TECHNICAL FEATURES
- Recommended maximum blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Soft 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 D901 DIDECO LILLIPUT 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 D901
DIDECO LILLIPUT is a NEW BORN oxygenator intended for use in procedures on
patients with a body weight of less than 8 Kg (17.6 lb.). The D901 DIDECO LILLIPUT
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 D901 DIDECO LILLIPUT).
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)
GB - ENGLISH - INSTRUCTIONS FOR USE
800 ml/min
Microporous polypropylene
0.34 Sqm
0.02 Sqm
min 25 ml
max 90 ml
60 ml
3/16"-1/4" (4.76 - 6.35 mm)
3/16"-1/4"
3/16"-1/4"
3/16"-1/4"
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.
- Store at room temperature.
- Keep dry.
- Always apply and maintain a correct dose and accurate monito-ring 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 resterilise.
- After use, dispose of the device in accordance with applicable regulations in
force in the country of use.
GB - ENGLISH
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
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