Eurosets TRILLY PAEDIATRIC AF Instrucciones De Uso página 61

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monitoring during and after the bypass.
• It is recommended not to expose the blood to a
temperature lower than 18°C (64°F) and higher
than 37°C (99°F).
• To safely apply a vacuum to the device, carefully
read section "USE OF THE ACTIVE VENOUS
DRAINAGE WITH VACUUM (VAVD)".
• 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).
• The extracorporeal circulation shall be
carefully and continuously checked throuhout
the cardiopulmonary bypass procedure.
• 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.
SET UP
1) POSITIONING THE HOLDER
Position the TRILLY PAEDIATRIC AF 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
Oxy Adult/Paediatric Holder Instructions for use
for two different height holder positions).
2) SECURING TRILLY PAEDIATRIC AF 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
reservoir allows
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 ports accidentally come into
contact with lubricating agents which may
encourage accidental disconnection.
to Secure TRILLY PAEDIATRIC AF on the holder.
Check that TRILLY PAEDIATRIC AF fits perfectly
and fully into place with the holder support
inserts in the two housing holes and check that
the oxygenator is securely in place in the support
jaws.
Check and, if necessary, tighten the connections
of the lines connected to the oxygenator.
Only in this condition it will be possible to secure
TRILLY PAEDIATRIC AF by turning the fastening
lever anticlockwise, until block is achieved.
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the TRILLY
PAEDIATRIC AF Hansen fittings (indifferently to
the water inlet or outlet).
WARNINGS
• The water temperature at the heat exchanger
inlet must not exceed 42°C (108°F).
• The water pressure in the heat exchanger
must not exceed 1500 mmHg (200 kPa).
4) CHECK THE HEAT EXCHANGER
WARNING
• Check the heat exchanger by recirculating
water inside the heat exchanger for a
few minutes. The integrity of the unit is
guaranteed if there are absolutely no leaks
from the water compartment.
5) CIRCUIT CONNECTIONS
WARNINGS:
• All the connections downstream of the pump
must be secured by means of ties.
• Remove the label (labelled with "Remove
before use") and the yellow cap from the
VENT/VACUUM port.
• Before use remove from the pressure relief
valve the yellow tab (labelled with "Remove
before use").
• The action of the pressure relief valve does
not prevent from excessive negative pressure
in the reservoir caused by sudden abnormal
high vacuum level (i.e. vacuum regulator
device failure).