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Verfügbare Sprachen
Verfügbare Sprachen
GB - ENGLISH
TABLE OF CONTENTS
I.
A.
DESCRIPTION
SYNERGY is an integrated system for hemodynamic support, gas
exchange in extracorporeal perfusion and cardiopulmonary bypass for
periods of up to 6 hours. SYNERGY comprises the following elements
integrated into one assembly: a microporous hollow-fibre membrane
oxygenator and heat exchanger, a venous bubble trap, an arterial filter
and a centrifugal pump.
The arterial filter includes a 40 μm screen.
The centrifugal pump is equipped with a vane impeller designed to
move blood by centrifugal force.
The venous bubble trap is designed for trapping venous air using a 120
μm screen.
SYNERGY 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]
B.
TECHNICAL FEATURES
Maximum flow rate
Membrane type
Membrane surface area
Heat exchanger surface area
Arterial filter
- Filter screen
- Type
- Surface area
Bubble Trap
- Filter screen
- Type
- Surface area
Static priming volume (post use
recovered)
Priming volume
(oxygenator module + heat exchanger + arterial
filter + centrifugal pump + venous bubble trap)
Connections:
- Venous return
- Arterial filter outlet
- Blood cardioplegia outlet
Maximum pressure rating:
- Blood pathway
- Gas pathway at outlet
- Water pathway
C.
INTENDED USE
SYNERGY is intended to be used in adult surgical procedures
requiring extracorporeal gas exchange support and blood temperature
control.
SYNERGY must not be used longer than 6 hours. Contact with blood
for longer periods is inadvisable.
SYNERGY is intended for use only with the Sorin Group Deutschland
GB - ENGLISH - DIRECTION FOR USE
SYNERGY for adult bypass.
8000 ml/min
Microporous polypropylene
3/8" (9.5 mm)
2250 mmHg (300 kpa/ 3 bar / 43,5 psi)
Stöckert Centrifugal Pump Console.
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
2.0 m²
0.14 M²
40 μm
polyester
0.04 m²
120 μm
polyester
0.01 m²
620 ml
The following is general safety information with the aim of advising
the operator in preparing to use the device.
681 ml
- 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
pos-lock
operation.
- For use by professionally trained personnel only.
- Do not use the device if it has been cracked, dropped or
otherwise physically damaged.
- 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 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
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 instructions for use
This way up
Fragile; handle with care
Keep away from heat
Keep dry
ea
Quantity
5
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