sorin dideco KIDS D130, Instructions For Use Manual

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GB - ENGLISH 3
GB – ENGLISH - INSTRUCTIONS FOR USE
GB - ENGLISH
I. CONTENTS
I. Contents
A. Description
B. Technical
features
C. Intended use
D. Safety information
E. Set-up
F. Priming
procedure
G. Medical devices for use with D130/ D131 KIDS
H. Return of used products
I. Limited
Warranty
A. DESCRIPTION
D130/ D131 KIDS is an arterial blood filter 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 suitable purge lines.
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 PATIENT SIZE PORE SIZE
D130 Neonatal 40 μm
D131 Infant 40 μm
B. TECHNICAL FEATURES
CODE Static
volume (ml)
Filtering
surface (Sqcm)
Max. blood flow
rate (l/min)
Connectors
(inches)
D130 16 11 0.7
3/16" (4.76
mm)
D131 28 23 2.5
1/4" (6.35
mm)
C. INTENDED USE
D130/ D131 KIDS with 40 μm screen is recommended for use in the
arterial line of the extracorporeal circuit during any procedure that
requires cardiopulmonary bypass. The filter is used to trap and remove
gaseous emboli as well as particulate debris that maybe 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 device should be used in combination with medical devices listed
at paragraph G (Medical devices for use with D130/ D131 KIDS).
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 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.
CAUTION 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
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 User should carefully check the device during set-up
and priming for leaks. Do not use if any leak is detected.
•
The device must be used in accordance with the
instructions for use provided in this manual.
•
The device is intended to be used by professionally trained
personnel.
•
SORIN GROUP ITALIA is not responsible for problems
arising from inexperience or improper use.
•
FRAGILE, handle with care.
•
Keep dry. Store at room temperature.
•
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
after use. Therefore, reuse on other patients might cause
cross-contamination, infection and sepsis. In addition, the
reuse increases the probability of product failure (integrity,
functionality and clinical effectiveness).
•
The device contains phthalates. Considering the nature of
contact with the body, the limited duration of contact and
the number of treatments per patient, the amount of
phthalates which might be released from the device does
not raise specific concerns about residual risks. Further
information is available on request from Sorin Group Italia