GB - ENGLISH
7
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 and recirculation procedure
G. Initiating
bypass
H. Operation during bypass
I. Terminating
bypass
J. Blood recovery after bypass
K. Use of active venous drainage with vacuum
L. Oxygenator
change-out
M. Medical devices for use with the D100 KIDS
N. Return of used products
O. Limited
Warranty
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 required. 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 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] 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
700 ml/min
Membrane type
Microporous Polypropylene
Membrane surface area
0.22 m2
Heat exchanger surface area
0.03 m2
Static priming volume
31 ml
(oxygenating heat exchanger)
Connections:
-
Oxygenating module venous inlet
3/16"-1/4"
-
Oxygenating module arterial outlet
3/16"
-
Gas Inlet Port
1/4"
-
Gas scavenging Port
1/4"
Version [A]: OPEN SYSTEM
Reservoir Capacity
500 ml
Minimum operating level
10 ml
Cardiotomy filter pore size
33
μ
m
Venous filter pore size
51
μ
m
Connections:
-
Venous return
3/16"-1/4"
-
Blood outlet
3/16"-1/4"
-
Cardiotomy filtered ports
7 x Luer-locks
-
Cardiotomy vertical priming filtered port
3/16”
-
Cardiotomy bypass port
Luer-lock
-
Vent port
1/4”
Version [B]: CLOSED SYSTEM
Soft venous reservoir volume
min: 25 ml
max: 90 ml
Connections:
-
Venous return
3/16"-1/4"
-
Cardiotomy Inlet
3/16"-1/4"
-
Blood outlet
3/16"-1/4"
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 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
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
This way up
Fragile; handle with care
Keep away from heat
ea
Quantity
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 leaks are detected.
- The device must be used in accordance with the instructions for use provided in
this manual.
- For use by professionally trained personnel only.
Содержание KIDS D100
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