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GB - ENGLISH
CONTENTS
A. DESCRIPTION
I.
L.
MEDICAL DEVICES FOR USE WITH SYNTHESIS C PH.I.S.I.O
SYNTHESIS C Ph.I.S.I.O is a new-concept microporous hollow fibre membrane
oxygenator. It is composed of a gas exchange module connected to an integrated
heat exchanger, an arterial filter and a collapsible venous reservoir.
The self-debubbling arterial filter is made up of a 40 µm filter screen.
SYNTHESIS C 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 C Ph.I.S.I.O with integrated arterial filter and collapsible
venous reservoir.
B. TECHNICAL FEATURES
- Suggested max. blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Collapsible venous reservoir
Max volume
Filter area
Filtering surface
- Arterial filter
Filter screen:
Type:
Useful surface area
Recovered priming volume
- Connections:
Venous return
Venous reservoir outlet
Oxygenator venous inlet
Arterial filter outlet
C. INTENDED USE
SYNTHESIS C 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 venous blood reservoir and filter element to
eliminate blood component aggregates larger than 40 µm. The blood to be treated
must contain anticoagulant.
SYNTHESIS C Ph.I.S.I.O is an ADULT oxygenator intended for use in operations on
adults patients.
SYNTHESIS C Ph.I.S.I.O must not be used for longer than 6 hours. Contact with
blood for longer periods is inadvisable.
SYNTHESIS C Ph.I.S.I.O must be used in combination with the medical devices
listed in section L (Medical devices for use with SYNTHESIS C 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
GB - ENGLISH - INSTRUCTION FOR USE
8000 ml/min
Microporous polypropylene
2.0 m
0.14 m
1200 ml
120 µm
0,01 m
40 m
polyester
0.04 m
430 ml
(oxygenator module + heat exchanger +
arterial filter)
1/2" (12.7 mm)
3/8" (9.53mm)
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.
EXPLANATION OF SYMBOLS USED ON THE LABELS
2
2
2
ea
2
The following is general safety information with the aim of advising the operator in
3/8"
preparing to use the device.
3/8"
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 after 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).
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 instructions for use
Attention, see instructions for use
This way up
Units
Fragile; handle with care
Keep away from heat
Keep dry
5
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