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Les langues disponibles
Les langues disponibles
GB - ENGLISH
I. CONTENTS
I.
Contents
I.
A. DESCRIPTION
MICRO is an arterial blood filter 27 or 40 µm screen.
The fluid path inside the filter is recommended for use to permit the
effective separation of gaseous emboli from the fluid. Removal is
performed by a suitable purge line.
Blood contact surfaces of Ph.I.S.I.O. device version have been coated
with Ph.I.S.I.O. (PC phosphorylcholine) coating. 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, non pyrogenic, supplied STERILE
and packaged singly. 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:
CODE
DESCRIPTION
D 732
MICRO 27
D 731
MICRO 27
D 735
MICRO 27
D 734
MICRO 40
D 733
MICRO 40
D 736
MICRO 40
B. TECHNICAL FEATURES
CODE
Prime
Filtering
volume
surface
recovered
(Sqcm)
(ml)
D 732
195
655
D 731
100
340
D 735
47
150
D 734
195
655
D 733
100
340
D 736
47
150
C. INTENDED USE
The D 731, D 732, D 735 MICRO 27 and the 733, D 734, D 736
MICRO 40are recommended for use in the arterial line of the
extracorporeal
circuit
during
cardiopulmonary bypass. The filters are used to trap and remove
gaseous emboli as well as particulate debris that may be introduced
through the arterial line. The device should not be used longer than 6
hours. Contact with blood for longer periods is not advised.
The blood to be treated should contain anticoagulant.
GB - ENGLISH - INSTRUCTIONS FOR USE
PATIENT SIZE
PORE SIZE
Adult
27 µm
Adult
27 µm
Infant-Newborn
27 µm
Adult
40 µm
Adult
40 µm
Infant-Newborn
40 µm
Max. blood
Connectors
flow rate
(inches)
(l/min)
8
3/8" (
9.53 mm
6
3/8"
3/16"-1/4"
2.5
(
4.76-6.35 mm
8
3/8"
6
3/8"
2.5
3/16"-1/4"
any
procedure
that
requires
With regards to patient's size, SORIN GROUP ITALIA recommends to
use each version of MICRO filters according to paragraph A
instructions (DESCRIPTION), taking into account blood maximum flow
limitations (l/min) indicated by paragraph B (TECHNICAL FEATURES).
The device should be used in combination with medical devices listed
at paragraph G (Medical devices for use with MICRO).
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:
Indicates serious adverse reactions and potential
safety hazards for practitioner and/or patient that can
occur in the proper use or misuse of the device, and
also the limitations of use and the measures to be
adopted in such cases.
Indicates any special care to be exercised by a
practitioner for the safe and effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
For single use only (Do not reuse)
Batch code (number)
(reference for product traceability)
Use by (Expiry date)
Manufactured by
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
ea Quantity
Keep away from heat
Keep dry
GB - ENGLISH
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