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Les langues disponibles
TABLE OF CONTENTS
A. DESCRIPTION B. TECHNICAL SPECIFICATIONS C. INDICATIONS
FOR USE D. SAFETY INFORMATION E. PREPARATION AND SETUP F.
PRIMING
AND
RECIRCULATION
PERFUSION H. DURING PERFUSION I. TERMINATING PERFUSION J.
BLOOD RECOVERY AFTER PERFUSION K. REPLACEMENT L. MEDICAL
DEVICES TO BE USED WITH ECC.O
N. LIMITED WARRANTY
A. DESCRIPTION
ECC.O
is an integrated system for hemodynamic support, gas
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exchange in extracorporeal perfusion and cardiopulmonary bypass for
periods of up to 6 hours. ECC.O
cardiorespiratory support for a period of up to 5 days. ECC.O
the following elements integrated into one assembly: a hollow-fiber
membrane oxygenator and heat exchanger, a venous bubble trap, and a
centrifugal pump.
The centrifugal pump is equipped with a vaned impeller designed to
move blood by centrifugal force.
The venous bubble trap is designed for trapping venous air using a 120
μm screen.
The device is single-use, non-toxic, non-pyrogenic, supplied STERILE in
individual packaging. Sterilized by ethylene oxide.
The level of ethylene oxide residuals in the device is in conformity with
the provisions of the legislation in force in the country of use.
The device is available in the following versions:
[A]
ECC.O
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for adult bypass and extended extracorporeal support.
B. TECHNICAL SPECIFICATIONS
Reccomended maximum flow rate
Membrane type
Membrane surface area
Heat exchanger surface area
Bubble Trap
- Filter screen
- Type
- Surface area
Priming volume
(oxygenator module + heat exchanger + centrifugal pump + venous
bubble trap)
Connections:
- Venous return
- Arterial outlet
- Arterial Blood Access Port
Maximum Rated Pressures
- Blood Pathway
- Gas Pathway
- Water Pathway
C. INDICATIONS FOR USE
ECC.O
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Is intended to be used In adult surgical procedures requiring
extracorporeal gas exchange support and blood temperature control, as
well as during extended respiratory support applications.
ECC.O
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can be used in extracorporeal circulation (ECC) for a maximum
of 6 hours. ECC.O
can be used from the beginning or after 6 hours of
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ECC for respiratory and/or cardiorespiratory support.
ECC.O
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must not be used in ECC for more than 6 hours, nor is it to be
used for ECC after use in extended respiratory support.
ECC.O
is intended for use in procedures
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less than 80 kg (176 lb).
The blood to be treated should contain anticoagulant.
ECC.O
must not be used longer than 5 days. Contact with blood for
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longer periods is inadvisable.
GB – ENGLISH – INSTRUCTIONS FOR USE
PROCEDURE
G.
STARTING
M. RETURN OF USED PRODUCT
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5
can also be used for respiratory and/or
comprises
5
5 liters/minute
Polymethylpentene
polyester
3/8" (9.5 mm)
3/8" (9.5 mm)
500 mmHg (67 kPa)
0 mmHg (0 kPa) at outlet
750 mmHg (100 kPa)
on patients with a body weight of
GB – ENGLISH – INSTRUCTIONS FOR USE
ECC.O
should be used in combination with medical devices listed in
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section L. (Medical devices to be used with ECC.O
D. SAFETY INFORMATION
The following symbols are used in the text in order to assure proper and
safe use of the device:
Indicates potential risks and possible consequences to the user
and/or the patient deriving from use of the device in normal or
abusive conditions, as well as the limitations of use and the
measures to be adopted should these events occur.
Indicates possible precautions the user must adopt for safe and
effective use of the device.
EXPLANATION OF THE SYMBOLS USED ON THE LABELS
1.2 m²
0.14 m²
120 μm
0.01 m²
390 ml
pos-lock
General safety information is provided below with the intent of advising
and informing the user prior to use of the device.
In addition, specific information on safety is included in the sections of
the instructions for use where they may affect the operation to be
performed.
ECC.O
5
-
ECC.O
5
-
The user is fully responsible for improper use or use different
-
from that indicated.
Do not use the device if leaks or other anomalies are found.
-
FRAGILE. Handle with care.
-
Do not expose to temperatures below 0°C (32°F) or above 60°C
-
(140°F).
Keep dry.
-
Always apply and maintain a correct dose and accurate
-
monitoring of the anticoagulant before, during and after
bypass. The risk of total systemic anticoagulation must be
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
Non sterile
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
Keep away from heat
Temperature limitation
0°C (32°F)÷ 60°C (140°F)
Keep dry
must be used following the instructions provided.
must only be used by trained, qualified personnel.
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).
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