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The following is general safety information for the
operator preparing to use the device. Specific safety
information is also given in the instructions for
use where this information is relevant for correct
operation.
WARNINGS
•
Carefully read the instructions before use.
• Store in a dry place between 0°C (32°F) and
40°C (104°F).
• FRAGILE, handle with care.
• Single-use device. Do not reuse. Do not clean or
resterilize the device for subsequent reuse.
• Improper reuse may cause transfusion
reactions, cross-infection and alteration of
device performance.
• For use by professionally trained personnel
only.
• The device must be used in accordance with
these instructions. EUROSETS cannot be
held responsible for damage deriving from
inexperience or improper use.
• Carefully check the device seal during priming
and ECC. Any leakage may give rise to loss of
sterility, blood leakage, gaseous embolism. If
a leakage during priming or ECC is noticed,
replace the defective device following good
perfusion practices.
• The connection lines must be correctly
connected in order to prevent any potential
tube constriction or occlusion which may lead
to reduced blood and/or gas flow.
• To safely apply a vacuum to the device, carefully
read section L of these instructions for use.
• The special pressure relief valve on the
cardiotomy/venous
discharge positive pressures higher than 5.3
mmHg (0.7 kPa) and negative pressures lower
than -75.2 mmHg (-10 kPa).
• After use, dispose of the device in accordance
with the regulations in force on biologically
hazardous waste in the country of use.
• For further information and/or in case of a
complaint, contact EUROSETS or an authorised
local representative.
CAUTION
• Follow an anticoagulation protocol and monitor
anticoagulation before, during and after the
bypass.
32
reservoir
allows
The benefit of using an extracorporeal support
must be weighed against the risk of systemic
anticoagulation and it must be prescribed by
a physician. Maintain adequate anticoagulation
before and during the procedure.
• Federal law (USA) restricts this device to sale by
or on the order of a physician.
G. SETUP
1) POSITIONING THE HOLDER
Position the HORIZON CVR holder on the pump
stand and secure it by means of the knob found
at the end of the carrying arm.
Verify that the holder is in the right position (see
Adult/Paediatric Oxygenators Holder Instructions
for Use for two different height holder positions).
2) SECURING HORIZON CVR ON THE HOLDER
WARNINGS
• Check the expiry date on the label. Do not use
the device after this date.
• The device has been sterilized by ethylene
oxide and is non-pyrogenic. Its sterility and
integrity are guaranteed only if the package
is intact.
• Carefully inspect the device before use. Do
not use it if the package is wet, open or
damaged, if the device is visibly damaged or
if the protective caps are not in place.
• The device must be used immediately after
opening the sterile package.
• The device must be handled aseptically.
• Do not use solvents such as alcohol, ether,
acetone, etc., as contact may cause damage
to the device.
• Do not allow halogenated liquids such as
Halothane and Fluothane to come into
to
contact with the polycarbonate housing of
the device. This would cause damage which
may compromise the integrity and proper
functioning of the device.
• Avoid that the connectors accidentally come
into contact with lubricating agents which
may encourage accidental disconnection.
Secure HORIZON CVR on the holder.
Check that HORIZON CVR fits perfectly and fully
into place with the holder support inserts in the
two housing holes.
3) CONNECTING THE CIRCUIT
WARNINGS
• All the connections downstream of the pump
