Table des Matières
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Les langues disponibles
Les langues disponibles
GB - ENGLISH
I. CONTENTS
I.
Contents
H. Operation during bypass
I.
N. Medical devices for use with the D 905 EOS
A. DESCRIPTION
The D 905 EOS 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 (fig.2, ref.1)
2.
Cardiotomy Reservoir with integrated cardiotomy filter (fig.2, ref.2)
These two compartments are connected by means of a connection key (fig.2, ref.3).
Devices coated with Ph.I.S.I.O are used when a coated blood path is desired. The
Ph.I.S.I.O coating improves the blood compatibility of the device by reducing platelet
adhesion on the coated surfaces. 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
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
Venous Reservoir
Cardiotomy Reservoir
- Priming volume (recovered)
(oxygenating module + heat exchanger)
- Connections:
Venous reservoir return
Venous reservoir outlet
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The SORIN GROUP ITALIA D 905 EOS Adult Hollow Fiber Oxygenator with Integral
Hardshell Venous Reservoir is intended for use in adults who undergo
cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides
oxygenation and carbon dioxide removal from venous blood. The integrated heat
exchanger provides blood temperature control and allows the use of hypothermia or
aids in the maintenance of normothermia during surgery. The venous reservoir with
cardiotomy filter is intended to collect blood aspirated from the operating field during
surgical procedures and the blood from patient's veins (gravity or vacuum assisted)
during normal operation to assure the proper oxygenation capability of the device.
The device is intended to be used for six hours or less. Contact with blood for longer
periods is not advised. The blood to be treated should contain anticoagulant.
The D 905 EOS should be used in combination with medical devices listed in section
N (Medical devices for use with the D 905 EOS).
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.
Indicates any special care to be exercised by a practitioner for the safe and
GB - ENGLISH - INSTRUCTIONS FOR USE
5.0 l/min
Microporous Polypropylene
1.1 m
2
0.14 m
2
3200 ml
2000 ml
1200 ml
160 ml
1/2" (12.7 mm)
(3/8" adapter supplied)
3/8" (9.53 mm)
3/8" (9.53 mm)
3/8" (9.53 mm)
effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
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.
- Always give and maintain a correct dose and accurate monitoring of the
anticoagulant before, during and after the bypass.
- 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
available on request from Sorin Group Italia.
- The device must not undergo any further processing.
- Do not resterilise.
- After use, dispose of the device in accordance with applicable regulations in
force in the country of use.
- The device must only be used if sterile. In the event of the device being
Supplied NOT STERILE (in which case, this is indicated by the wording "NOT
STERILE" on the pack) contact SORIN GROUP ITALIA or an authorised dealer
GB - ENGLISH
For single use only (Do not reuse)
Batch code (number) (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
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
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