SORIN GROUP dideco kids d101, Instructions For Use Manual, Page: 5 / 104

GB - ENGLISH 5
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 D101 KIDS
N. Return of used products
O. Limited
Warranty
A. DESCRIPTION
The D101 KIDS is a microporous hollow fibre membrane oxygenator with a heat
exchanger integrated into the oxygenating module.
The D101 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] D101 KIDS OPEN SYSTEM (oxygenating module with integrated heat
exchanger, hardshell cardiotomy/venous reservoir, sampling manifold and
3/8”-1/4” locking adaptor)
[B] D101 KIDS OXYGENATING MODULE (oxygenating module with integrated
heat exchanger, sampling manifold).
B. TECHNICAL FEATURES
 Recommended max blood flow 2500 ml/min

Membrane type Microporous Polypropylene
 Membrane surface area 0.61 m
2
 Heat exchanger surface area 0.06 m
2
 Static priming volume
(oxygenating heat exchanger)
87 ml

Connections:
- Oxygenating module venous inlet 1/4”
- Oxygenating module arterial outlet 1/4”
- Gas Inlet Port 1/4”
- Gas scavenging Port 1/4”
Version [A]: OPEN SYSTEM

Reservoir Capacity 1500 ml
 Minimum operating level 30 ml
 Cardiotomy filter pore size 33 μ m

Venous filter pore size 51 μ m

Connections:
- Venous return 3/8”
- Blood outlet 1/4”
- Cardiotomy filtered ports
Suction Inlets 3 x 1/4” + 2 x 3/16”
Vertical Inlet 1/4”
Additional Inlets 3 x Luer Lock + 1 x Luer/Pos Lock
- Unfiltered inlet luer lock
- Quick prime port 1/4’’
- Vent port 1/4”
C. INTENDED USE
The D101 KIDS Infant 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 2.5 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 aidsin the maintenance of
normothermiaduring surgery. The venous reservoir is intended to collect blood aspirated
from the operating field during surgical procedures and blood from patient’s veins (gravity
or vacuum assisted) during normal operation, to always assure the proper oxygenation
capability of the device.The D101 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 D101 KIDS).
Version [A], OPEN SYSTEM:
The D101 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
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.
- 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