Gb - English - Instructions For Use; Description; Technical Features; Intended Use - Sorin Group Micro Gebrauchsanweisung
Inhaltsverzeichnis
Verfügbare Sprachen
Verfügbare Sprachen
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.
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 Recovered
Filtering
volume
surface
(ml)
(Sqcm)
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
D 731, D 732, D 735 MICRO 27 with 27 µm screen and D 733, D 734,
D 736 MICRO 40 with 40 µm screen are intended for use in the arterial
line of the cardiopulmonary circuit. The blood to be treated should
contain anticoagulant.
MICRO filters effectively eliminate gaseous emboli and remove blood
components aggregates present in the arterial line. They filter emboli
which are respectively greater than 27 or 40 µm in size which may be
harmful to the patient.
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 not be used longer than 6 hours. Contact with blood
for longer periods is not advised.
The device should be used in combination with medical devices listed
at paragraph G (Medical devices for use with MICRO).
2
GB - ENGLISH - INSTRUCTIONS FOR USE
PATIENT SIZE
PORE SIZE
Adult
27 µm
Paediatric
27 µm
Infant-Newborn
27 µm
Adult
40 µm
Paediatric
40 µm
Infant-Newborn
40 µm
Max. blood
Connectors
flow rate
(inches)
(l/min)
7
3/8" (
9.53 mm
5
3/8"
3/16"-1/4"
2.5
(
4.76-6.35 mm
7
3/8"
5
3/8"
2.5
3/16"-1/4"
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)
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 instruction for use
Attention, see instruction for use
This way up
Fragile; handle with care
ea
Quantity
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.
Also, specific safety information is given in the instructions for use at
locations in the text where that information is relevant for correct
operation.
The device must only be used if STERILE
Kapitel
Inhaltsverzeichnis
