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Idiomas disponibles
Idiomas disponibles
GB - ENGLISH
I.
CONTENTS
I.
Contents
H. Operation during bypass
I.
A. DESCRIPTION
The D100 KIDS is a microporous hollow fibre membrane oxygenator with a heat exchanger
integrated into the oxygenating module.
The D100 KIDS is coated with Phosphorylcholine (Ph.I.S.I.O) 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:
[A]
D100 KIDS OPEN SYSTEM (oxygenating module with integrated heat exchanger,
hardshell cardiotomy/venous reservoir, sampling manifold)
[B]
D100 KIDS CLOSED SYSTEM (oxygenating module with integrated heat exchanger,
soft venous reservoir, sampling manifold)
[C]
D100 KIDS OXYGENATING MODULE (oxygenating module with integrated heat
exchanger, sampling manifold).
B. TECHNICAL FEATURES
•
Recommended max blood flow
•
Reference blood flow (AAMI Standard)
•
Membrane type
•
Membrane surface area
•
Heat exchanger surface area
•
Static priming volume
(oxygenating module + heat exchanger)
•
Connections:
-
Oxygenating module venous inlet
-
Oxygenating module arterial outlet
-
Gas Inlet Port
-
Gas scavenging Port
Version [A]: OPEN SYSTEM
•
Reservoir Capacity
•
Minimum operative level
•
Cardiotomy filter pore size
•
Venous filter pore size
•
Connections:
- Venous return
- Blood outlet
- Cardiotomy filtered ports
- Cardiotomy vertical priming filtered port
- Cardiotomy bypass port
- Vent port
Version [B]: CLOSED SYSTEM
•
Soft venous reservoir volume
•
Connections:
- Venous return
- Cardiotomy Inlet
- Blood outlet
C. INTENDED USE
The D100 KIDS Newborn Hollow Fiber Membrane Oxygenator is intended for use in infants
who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a
maximum blood flow rate of 0.7 liters/minute. It provides oxygenation and carbon dioxide
removal from venous or suctioned blood. The integrated heat exchanger provides blood
temperature control and allows the use of hypothermia or aids in the maintenance of
GB - ENGLISH - INSTRUCTIONS FOR USE
700 ml/min
1000 ml/min
Microporous Polypropylene
0.22 m2
0.03 m2
31 ml
3/16"-1/4"
3/16"
1/4"
1/4"
500 ml
10 ml
33μm
51μm
3/16"-1/4"
3/16"-1/4"
7 x Luer-locks
3/16"
Luer-lock
1/4"
min: 25 ml
max: 90 ml
3/16"-1/4"
3/16"-1/4"
3/16"-1/4"
GB - ENGLISH
normothermia during surgery. The venous reservoir is intended to collect blood aspirated
from the operating field during surgical procedures and the blood from patient's veins (gravity
or vacuum assisted) during normal operation, to always assure the proper oxygenation
capability of the device. The D100 KIDS 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.
The device should be used in combination with medical devices listed in section M (Medical
devices for use with the D100 KIDS).
Version [A], OPEN SYSTEM:
The D100 KIDS Reservoir is also intended for use in vacuum assisted venous drainage
procedures (refer to section K).
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)
Date of manufacture
Sterile - Ethylene oxide
sterilised
Non Pyrogenic
Contains PHTHALATE
Latex free
Warning: Do not
resterilize.
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.
- For use by professionally trained personnel only.
- 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 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 must not undergo any further processing.
- Do not resterilize.
- After use, dispose of the device in accordance with applicable regulations in force in the
country of use.
- The device must only be used if STERILE.
- 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
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
7
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