Technical Features; Intended Use; Safety Information - dideco D 902 LiLLiPUt 2 Instrucciones Para El Uso

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 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 oxy-
genator with a heat exchanger integrated into the oxygenating modu-
le. 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 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
- Membrane surface area
- Heat exchanger surface area
- Soft venous reservoir volume
- Rigid 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 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 arte-
rial/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 devi-
ce is indicated in the text in the following way:
WARNING
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
2300 ml/min
3300 ml/min
Microporous 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"
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 infor-
mation 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
symbol non sterile on the pack) contact SORIN GROUP ITALIA or
an authorised dealer to agree on a sterilisation method.
- 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
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