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Idiomas disponibles
Idiomas disponibles
DIRECTIONS FOR USE
I. CONTENTS
I. Contents
A. Description
D. Safety information
H. Operation during bypass
The D 901 LILLIPUT 1 OPEN SYSTEM is a microporous hollow fibre
membrane oxygenator consisting of a gas exchange module with an
integrated heat exchanger and a Hardshell Reservoir divided into
two compartments:
1. Venous Reservoir (ref. 1)
2. Cardiotomy Reservoir with integrated cardiotomy filter (ref. 2)
These two compartments are connected by means of a connection
key (ref. 3).
The device is single use, non-toxic, non pyrogenic, supplied STE-
RILE 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 version:
[A] D901 LILLIPUT 1 OPEN SYSTEM (oxygenating module with
integrated heat exchanger, rigid venous reservoir, cardio-
tomy reservoir with 30 µm filter)
B. TECHNICAL FEATURES
- Recommended maximum blood flow
- Reference blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
Venous Reservoir
Cardiotomy Reservoir
- Static priming volume
(oxygenating module + heat exchanger)
- Minimum operative level
- Connections:
Venous return
Venous reservoir outlet
Oxygenator venous inlet
Oxygenating module arterial outlet
Aspiration lines
Cardiotomy depletion port
Quick priming port
C. INTENDED USE
The D 901 LILLIPUT 1 OPEN SYSTEM is intended for use in cardio-
pulmonary 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 901 LILLIPUT 1 OPEN SYSTEM 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 D 901 LILLIPUT 1 OPEN SYSTEM should not be used longer
1200 ml/min
Microporous Polypropylene
0.34 Sqm
0.02 Sqm
675 ml
425 ml
250 ml
60 ml
15 ml
3/16"-1/4" (4.76 - 6.35 mm)
3/16"-1/4"
3/16"-1/4"
3/16"-1/4"
Pos Lock
3/16" - 1/4"
7/32"
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 M ( Medical devices for use with the D 901 LILLI-
PUT 1 OPEN SYSTEM).
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:
Indicates serious adverse reactions and potential safety hazards for
practitioner and/or patient that can occur in the proper use or misu-
se 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)
LOT
(reference for product traceability)
Use by (Expiry date)
Date of manufacture
STERILE EO
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
REF
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Quantity
Keep away from heat
Keep dry
1
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