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Les langues disponibles
INSTRUCTIONS FOR USE
I. CONTENTS
I. Contents
H. Operation during bypass
A. DESCRIPTION
The D 903 AVANT is a microporous hollow fibre membrane oxygena-
tor consisting of a gas exchange module with an integrated heat
exchanger and a Hardshell Reservoir divided into two compartments:
1. Venous Reservoir (fig. 2, ref.3)
2. Cardiotomy Reservoir with integrated cardiotomy filter (fig. 2,
ref.4)
These two compartments are connected by means of a connection
key (fig. 2, ref. 5). 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] D 903 AVANT with safety valve (30 μm cardiotomy filter)
[B] D 903 AVANT without safety valve (30 μm cardiotomy filter)
B. TECHNICAL FEATURES
- Recommended max blood flow
- Reference blood flow
(AAMI Standard)
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
Venous Reservoir
Cardiotomy Reservoir
- 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 903 AVANT 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) to control the arterial/venous
temperature and as a venous blood reservoir. The blood to be treated
should contain anticoagulant. The D 903 AVANT is an ADULT
oxygenator intended for use in procedures on patients with a body
weight of less than 130 Kg (286 lb.). The D 903 AVANT should not be
used longer than 6 hours. Contact with blood for longer periods is not
advised. The D 903 AVANT should be used in combination with
medical devices listed in section M (Medical devices for use with the
D 903 AVANT).
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:
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
to be adopted in such cases.
7500 ml/min
10000 ml/min
Microporous Polypropylene
1.7 m
2
0.14 m
2
4700 ml
3500
1200
250 ml
1/2" (12.7 mm)
3/8" (9.53 mm)
3/8"
3/8"
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 - 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
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 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.
- Do not expose to temperatures below 0°C (32°F) or above 60°C (140°F).
- Keep dry.
- Always give and maintain a correct dose and accurate monitoring
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