Technical Features; Intended Use; Safety Information - SORIN GROUP D901 LILLIPUT 1 Mode D'emploi

GB - ENGLISH
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. Use of cardiotomy for post-operative drainage
L. Oxygenator replacement
M. Medical devices for use with the D 901 LILLIPUT 1 OPEN SYSTEM
N. Return of used products
O. Limited Warranty
A. DESCRIPTION
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 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 version:
[A] D901 LILLIPUT 1 OPEN SYSTEM (oxygenating module with integrated
heat exchanger, rigid venous reservoir, cardiotomy reservoir with 30 µm
filter)
B. TECHNICAL FEATURES
- Recommended maximum blood flow
- Reference blood flow
(AAMI Standard)
- Membrane type Microporous
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
Venous Reservoir
Cardiotomy Reservoir
- Recovered 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
Cardiotomy bypass
C. INTENDED USE
The D 901 LILLIPUT 1 OPEN SYSTEM 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 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 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 LILLIPUT 1 OPEN SYSTEM).
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.
GB - ENGLISH - INSTRUCTIONS FOR USE
800 ml/min
1200 ml/min
Polypropylene
0.34 Sqm
0.02 Sqm
675 ml
425 ml
250 ml
3/16"-1/4" (4.76 - 6.35 mm)
3/16"-1/4"
3/16"-1/4"
3/16"-1/4"
4 x 3/16"-1/4"
Pos Lock
3/16" - 1/4"
1/4", 3/16"
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
60 ml
15 ml
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 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
GB - ENGLISH
For single use only (Do not reuse)
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
3