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Verfügbare Sprachen
GB - ENGLISH
CONTENTS
A.
DESCRIPTION
I.
SYNTHESIS 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 hard-shell venous reservoir. The self-debubbling arterial filter is made
up of a 40 m filter screen.
Synthesis Ph.I.S.I.O. and Synthesis Ph.I.S.I.O/M. are 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 versions:
[A]
SYNTHESIS oxy module with venous reservoir and integrated
arterial filter. (only for Japanese market)
[B]
SYNTHESIS PHISIO oxy module with venous reservoir and
integrated arterial filter Phisio coated
[C]
SYNTHESIS PHISIO oxy module Phisio coated with hard-shell
venous reservoir and integrated arterial filter
Unless otherwise specified, the three models are hereinafter referred to as SYNTHESIS.
B. TECHNICAL FEATURES
Suggested max. blood flow
Membrane type
Membrane surface area
Heat exchanger surface area
Rigid venous reservoir volume:
- Arterial filter
Filter screen
Type
Surface area
Recovered priming volume
(oxygenator module + heat exchanger +
arterial filter)
Connections:
Venous return
Venous reservoir outlet
Oxygenator venous inlet
Arterial filter outlet
C. INTENDED USE
SYNTHESIS 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 gas emboli
and remove blood component aggregates larger than 40 µm. The blood to be treated
must contain anticoagulant.
SYNTHESIS is an ADULT oxygenator intended for use in operations on adult patients.
SYNTHESIS must not be used for longer than 6 hours. Contact with blood for longer
periods is inadvisable.
SYNTHESIS must be used in combination with the medical devices listed in paragraph N
(Medical devices for use with SYNTHESIS).
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
GB - ENGLISH - DIRECTION FOR USE
8000 ml/min
Microporous polypropylene
2.0 m
2
0.14 m
2
max. 4300 ml
min. 300 ml
40 m
polyester
0.04 m2
430 ml
1/2" (12.7 mm)
3/8" (9.53 mm)
3/8"
3/8"
GB - ENGLISH
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.
EXPLANATION OF SYMBOLS USED ON THE LABELS
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
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
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