Table Des Matières - dideco D901 LiLLiPUT Mode D'emploi

INSTRUCTIONS FOR USE
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 D901 DIDECO LILLIPUT
M. Return of used products
N. Limited Warranty
A.DESCRIPTION
The D901 DIDECO LILLIPUT is a microporous hollow fibre mem-
brane oxygenator with a heat exchanger integrated into the oxyge-
nating 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 coa-
ted 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
- Reference blood flow
(AAMI Standard)
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Soft venous reservoir volume
- Static 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 (tran-
sfer 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 lon-
ger than 6 hours. Contact with blood for longer periods is not advi-
sed. 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 poten-
tially dangerous situations and to ensure correct and safe use of the
device is indicated in the text in the following way:
800 ml/min
1200 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"
WARNING
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 mea-
sures to be adopted in such cases.
CAUTION
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)
LOT
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
STERILE EO
Sterile - Ethylene oxide sterilised
PYROGEN
Non Pyrogenic
PHTHALATE
Contains PHTHALATE
LATEX
Latex free
Warning: Do not resterilize.
Contents sterile only if package is not
opened, damaged or broken
REF
Catalogue (code) number
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.
WARNING
- The device must only be used if STERILE. In the event of the
device being supplied NOT STERILE (this is indicated by the
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