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GB - ENGLISH
TABLE OF CONTENTS
A. DESCRIPTION
SYNTHESIS 4D is an integrated system for hemodynamic support, gas
exchange in extracorporeal perfusion and cardiopulmonary bypass for
periods of up to 6 hours. SYNTHESIS 4D comprises the following
elements integrated into one assembly: a microporous hollow-fibre
membrane oxygenator and heat exchanger, an arterial filter, a centrifugal
pump and a hard-shell venous reservoir.
The arterial filter includes a 40 μm screen. The centrifugal pump is
equipped with a vane impeller designed to move blood by centrifugal
force.
SYNTHESIS 4D 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 to the coated surfaces.
The device is single-use, non-toxic, non-pyrogenic, supplied
STERILE and individually packaged, 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 is available in the following versions:
[A]
SYNTHESIS 4D with integrated arterial filter, centrifugal
pump and venous reservoir for adult bypass.
B. TECHNICAL FEATURES
Maximum flow rate
Membrane type
Membrane surface area
Heat exchanger surface area
Arterial filter:
- Filter screen
- Type
- Surface area
Static priming volume (post use recovered)
Priming volume
(oxygenator module + heat exchanger + arterial filter
+ centrifugal pump)
Venous Reservoir:
- Max. Cardiotomy flow rate
- Maximum reservoir volume
- Minimum reservoir volume
- O/U pressure relief valve
Connections :
- Venous inlet
- Arterial filter outlet
- Blood Cardioplegia outlet
Maximum Pressure Rating:
- Blood Pathway
- Gas Pathway at outlet
- Water Pathway
GB - ENGLISH - DIRECTION FOR USE
Microporous polypropylene
2
2.0 m
2
0.14 m
40 μm
polyester
2
0.04 m
451 ml
525 ml
4 l/min
4300 ml
300 ml
open at P<-80 mmHg
and at P>5 mmHg
1/2" (12.7 mm)
3/8" (9.53 mm)
2250 mmHg
(300 kPa/ 3 bar / 43,5 psi)
GB - ENGLISH
C. INTENDED USE
SYNTHESIS 4D is intended to be used in adult surgical procedures
requiring extracorporeal gas exchange support, to control the
arterial/venous temperature, as a venous blood reservoir /filter element to
eliminate gas emboli and remove blood component aggregates larger
than 40 µm.
SYNTHESIS 4D must not be used longer than 6 hours. Contact with
blood for longer periods is inadvisable.
SYNTHESIS 4D is intended for use only with the Sorin Group
Deutschland Stöckert Centrifugal Pump Console.
SYNTHESIS 4D must be used in combination with the medical devices
listed in paragraph N (Medical devices for use with SYNTHESIS 4D).
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 and also 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 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
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
This way up
Fragile; handle with care
Keep away from heat
Keep dry
ea
Units
The following is general safety information with the aim of advising
the operator in preparing to use the device.
- 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.
- Also specific information is given in the instructions for use at
locations in the text where that information is relevant for correct
operation.
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