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Verfügbare Sprachen
GB - ENGLISH
CONTENTS
I.
A.
DESCRIPTION
SYNTHESIS M is a new-concept microporous hollow fibre membrane oxygenator. It
is composed of a gas exchange module connected to an integrated heat exchanger
and arterial filter.
The debubbling arterial filter is made up of a 40 m filter screen.
Synthesis M Ph.I.S.I.O. is coated with Phosphorylcholine (Ph.I.S.I.O).
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, apyrogenic, supplied STERILE in individual
packaging. Sterilized by ethylene oxide.
The level of ethylene oxide residuals in the device is in conformity with the
provisions of the legislation in force in the country of use.
The device is available in the following version:
[A]
SYNTHESIS M Ph.I.S.I.O. oxygenator module with integrated arterial filter.
B.
TECHNICAL FEATURES
Suggested max. blood flow
Membrane type
Membrane surface area
Heat exchanger surface area
Arterial filter
- Filter screen
- Type
- Surface area
Recovered priming volume
(oxygenator module + heat exchanger +
arterial filter)
Connections:
- Oxygenator venous inlet
- Arterial filter outlet
C.
INTENDED USE
SYNTHESIS M Ph.I.S.I.O. is intended for use in cardiopulmonary bypass circuits as
substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control
the arterial/venous temperature, and as filter element to eliminate gas emboli and
remove blood component aggregates larger than 40 µm. The blood to be treated
must contain anticoagulant.
SYNTHESIS M Ph.I.S.I.O. is an ADULT oxygenator intended for use in operations
on adult patients.
SYNTHESIS M Ph.I.S.I.O. must not be used for longer than 6 hours. Contact with
blood for longer periods is inadvisable.
SYNTHESIS M Ph.I.S.I.O. must be used in combination with the medical devices
listed in paragraph L (Medical devices for use with SYNTHESIS M Ph.I.S.I.O).
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
the practitioner and/or the patient that may occur in proper use or misuse of
the device as well as the limitations of use and the measures 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.
GB - ENGLISH - INSTRUCTION FOR USE
8000 ml/min
Microporous polypropylene
2.0 m
0.14 m
40 m
polyester
0.04 m
430 ml
3/8"
3/8"
GB - ENGLISH
EXPLANATION OF SYMBOLS USED ON THE LABELS
2
2
2
The following is general safety information with the aim of advising the operator in
preparing to use the device.
Specific safety information is also given in the instructions for use at locations in the
text where that information is relevant for correct operation.
- The user should carefully check the device for leaks during set-up and
priming. Do not use if any leak is detected.
- The device must be used in accordance with the instructions for use
provided in this manual.
- For use by professionally trained personnel only.
- 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 apply and maintain a correct dose and accurately monitor 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 at the end of use.
Therefore, reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, reuse increases the probability of product
failure (integrity, functionality and clinical effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- After use, dispose of the device in accordance with the applicable
regulations in force in the country of use.
- The device must only be used if STERILE.
- The device contains phthalates. Considering the nature of body contact, the
limited contact duration and the number of treatments per patient; the
amount of phthalates which might be released from the device do not raise
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 instructions for use
Attention, see instructions for use
This way up
ea
Units
Fragile; handle with care
Keep away from heat
Keep dry
5
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