Gb - English - Instructions For Use - SORIN GROUP revolution Mode D'emploi

GB - ENGLISH
I. CONTENTS
I. Contents
A. Description
B. Technical features
C. Intended use
D. Safety information
E. Set-up
F. Suggested priming procedure
G. Procedure
H. Blood pump change-out
I. Medical devices for use with the REVOLUTION
J. Return of used products
K. Limited Warranty
A. DESCRIPTION
The REVOLUTION Centrifugal Blood Pump utilizes a rotating, vaned
impeller design to move blood by centrifugal force.
Blood contact surfaces of the REVOLUTION Ph.I.S.I.O. coated have
been modified to improve blood compatibility, resulting in reduced
platelet adhesion on the coated surfaces.
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
- Maximum Flow Rate
- Maximum Outlet Pressure800 mmHg (106,7 KPa / 1,06 bar / 15,5 psi)
- Priming volume
- Connections:
Inlet / Outlet port
C. INTENDED USE
The pump is intended for use only with Sorin Group Deutschland
Stöckert Centrifugal Pump Consoles in cardiopulmonary bypass
procedures for periods of up to six hours. Refer to the console
operator's manual for console operating procedures.
The pump has not been qualified through in vitro, in vivo, or clinical
studies for long term use (i.e., longer than six hours) as a bridge to
transplant, for pending recovery of the natural heart or extracorporeal
membrane oxygenation (ECMO). The use of this device for periods of
longer than six hours may result in pump failure, reduced pumping
capability, excessive blood trauma, degradation and/or corrosion of the
blood contacting materials (with the possibility of particles passing
through the CPB circuit to the patient), leaks, and increased potential
for gaseous emboli entering the arterial line.
The REVOLUTION should be used in combination with medical devices
listed in section I (Medical devices for use with the REVOLUTION).
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:
GB – ENGLISH - INSTRUCTIONS FOR USE
8000 ml/min
57 ml
3/8" (9.5 mm)
GB - ENGLISH
Sterile - Ethylene oxide sterilised
Non Pyrogenic
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
ea
Quantity
Keep away from heat
Keep dry
The following is general safety information with the aim of advising the
user when 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 any leak is detected.
- 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.
- Keep dry. Store at room temperature.
- Always administer and maintain a correct dose and accurate
monitoring of 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 and disinfected after use. Therefore,
reuse on other patients might cause cross-contamination,
infection and sepsis. In addition, the reuse increases the
probability of product failure (integrity, functionality and clinical
effectiveness).
- The device must not undergo any further processing.
- Do not resterilise.
- After use, dispose of the device in accordance with applicable
regulations in force in the country of use.
- The device must only be used if STERILE.
- For further information and/or in case of complaint contact
SORIN GROUP ITALIA or the authorised local representative.
- Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
- Currently SORIN GROUP ITALIA is
contraindications to the use of this coated device (REVOLUTION
Ph.I.S.I.O.).
not aware of any
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