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INSTRUCTIONS FOR USE
I. CONTENTS
I. Contents
A. Description
H. Operation during bypass
The COMPACTFLO EVOLUTION is a microporous hollow fibre
membrane oxygenator consisting of a gas exchange module with an
integrated heat exchanger and a Hardshell Reservoir.
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.
B. TECHNICAL FEATURES
- Recommended max blood flow
- Membrane type
- Membrane surface area
- Heat exchanger surface area
- Hardshell Reservoir Capacity
- Static priming volume
(oxygenating module + heat exchanger)
- Connections:
Venous reservoir return
Venous reservoir outlet
Oxygenator venous inlet
Oxygenating module arterial outlet
C. INTENDED USE
The COMPACTFLO EVOLUTION is intended for use in
cardiopulmonary bypass circuits as a device to replace the function
of the lungs, (transfer of oxygen and removal of carbon dioxide) to
control the arterial/venous temperature and as a venous blood
reservoir. The blood to be treated should contain anticoagulant.
The COMPACTFLO EVOLUTION is an ADULT oxygenator intended
for use in procedures on patients with a body weight of less than
130 Kg (286 lb.).
The COMPACTFLO EVOLUTION should not be used longer than 6
hours. Contact with blood for longer periods is not advised.
The COMPACTFLO EVOLUTION should be used in combination with
medical devices listed in section M (Medical devices for use with the
COMPACTFLO EVOLUTION).
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.
7500 ml/min
Microporous Polypropylene
1.7 m
2
0.14 m
2
4300 ml
250 ml
1/2" (12.7 mm)
3/8" (9.53 mm)
3/8"
3/8"
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)
LOT
(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.
Contents sterile only if package is not
opened, damaged or broken
REF
Catalogue (code) number
Attention, see instruction for use
This way up
Fragile; handle with care
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.
WARNING
- 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.
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