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INSTRUCTIONS FOR USE
I. CONTENTS
I. Contents
H. Operation during bypass
K. Use of cardiotomy for post-operative autotransfusion
A. DESCRIPTION
The D 905 EOS 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 compart-
ments:
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 ethyl-
ene oxide residuals in the device is within the limits established by
national regulations in the country of use.
B. TECHNICAL FEATURES
-
Recommended max blood flow
-
Membrane type
-
Membrane surface area
-
Heat exchanger surface area
-
Hardshell Reservoir Capacity
Venous Reservoir
Cardiotomy Reservoir
-
Recovered priming volume
(oxygenating module + heat exchanger)
-
Connections:
Venous reservoir return
-1
Venous reservoir outlet
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The D 905 EOS is intended for use in cardiopulmonary bypass cir-
cuits 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 905 EOS should not be used longer than 6 hours. Contact
with blood for longer periods is not advised.
The D 905 EOS should be used in combination with medical devices
listed in section M (Medical devices for use with the D 905 EOS).
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:
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
measures to be adopted in such cases.
5000 ml/min
Microporous Polypropylene
1.1 m2
0.14 m2
3200 ml
2000
1200
160 ml
1/2" (12.7 mm)
(3/8" adapter supplied)
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)
LOT
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Sterile - Ethylene oxide sterilised
STERILE
Non sterile
NON STERILE
REF
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
60°C
140°F
Temperature limitation
0°C (32°F)÷ 60°C (140°F)
0°C
32°F
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 moni-
toring of the anticoagulant before, during and after the bypass.
- For single use and for single patient use only.
- The device must not undergo any further processing.
- Do not resterilise.
- After use, dispose of the device in accordance with applicable
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