Table des Matières
Publicité
Les langues disponibles
Les langues disponibles
GB - ENGLISH
TABLE OF CONTENTS
A. DESCRIPTION
CSC14 is a single-use stainless steel heat exchanger with
integrated bubble trap.
The non-toxic, pyrogen-free CSC14 is supplied individually
packaged and sterilized with ethylene oxide.
The residual ethylene oxide content in the device complies
with the laws in force in the country where it is used.
The following model is available:
[A] CSC14 with integrated bubble trap.
B. TECHNICAL FEATURES
BLOOD FLOW RANGE
METAL CORE
Type/material
Surface area
BUBBLE TRAP
Type/material
Filter size
PRIMING VOLUME
CONNECTIONS
Blood inlet and outlet
Water compartment
SPECIAL DEVICES
C. INTENDED USE
CSC14 is recommended for use as a heating/cooling device
and bubble trap for
blood cardioplegia and clear fluid
perfusion in extracorporeal circulation associated with
cardiopulmonary bypass. It is suggested not to use CSC14
for more than 6 hours.
CSC14 can be used in combination with the devices listed in
paragraph I. MEDICAL DEVICES FOR USE WITH CSC14.
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 the practitioner and/or the
patient that may occur in proper use or misuse of the
device as well as 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 safe and effective use of the device.
GB- ENGLISH - INSTRUCTION FOR USE
Grooved and pleated
stainless steel
0.05 m²
Integrated polyester
screen
150 μm
30 ml
1/4"
1/2" O.D. (Hansen type)
Dial for easy and bubble
free priming
GB - ENGLISH
KEY TO 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
Latex free
Warning: Do not resterilize.
Contents sterile only if package is not
opened, damaged or broken
Contains PHTHALATE
Catalogue (code) number
ea
Quantity
Attention, see instructions
for use
This way up
Fragile; handle with care
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.
Specific safety information is also 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 for leaks
during set-up and priming. 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
accurately monitor 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
7
Publicité
Chapitres
Table des Matières
