Set Up; Circuit Connections; Gb - English - Instructions For Use - dideco D905 EOS ECMO Instrucciones De Uso

weighed against the benefits of extracorporeal support when
this device is considered.
– Technical complications during long-term use are generally
due to ineffective anticoagulation, wich reduces oxygenator
efficiency. Procedures lasting >6 houres should include
monitoring of blood compartment pressure drop, whole blood
coagulation time, inspection for thrombus formation and
system component wear.
- 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 contains phthalates. Considering the nature of
contact with the body, the limited duration of contact and the
number of treatments per patient, the amount of phthalates
which might be released from the device does not raise
specific concerns about residual risks. Further information is
available on request from Sorin Group Italia
– 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. In the event of the
device being supplied NOT STERILE (in which case, this is
indicated by the wording "NOT STERILE" on the pack) contact
SORIN GROUP ITALIA or an authorised dealer to agree on a
sterilisation method.
– This device does not allow the administation of anaesthetic
gases (i.e. isofluorane) to the patient.
– This device is Phosphorylcholine (Ph.I.S.I.O.) coated;
currently SORIN GROUP ITALIA is not aware of any
contraindication to the use of systems having components
treated with Phosphorylcholine.
– 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.
E. SET UP
1) POSITION THE HOLDER
Position the EOS MODULE holder on the pump structure by
means of the clamp at the upper end of the extension arm
(fig.1, ref.1).
2) FIX THE OXYGENATOR TO THE HOLDER
– Sterility is guaranteed only if the sterile packaging is not
wet, opened, damaged or broken. Do not use the device
if sterility cannot be guaranteed.
– Check the expiry date on the label attached. Do not use
the device after the date shown.
– The device must be used immediately after opening the
sterile packaging.
– The device must be handled aseptically.
4
Remove the device from the sterile packaging.
– Carry out a visual inspection and carefully check the
– Do not use solvents such as alcohol, ether, acetone, etc.:
Place the D905 EOS ECMO on the holder.
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the holder by means of the female
Hansen connectors SORIN GROUP ITALIA code 9028.
– The use of different connectors from those indicated
– Do not occlude the hole on the heat exchanger bottom
– The water temperature at the heat exchanger inlet must
– The water pressure in the heat exchanger must not
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the
heat exchanger for a few minutes. The integrity of the housing
is guaranteed if there are absolutely no leaks from the water
compartment or from the outlet hole of the safety channel.

5) CIRCUIT CONNECTIONS

All connections downstream of the pump must be secured
by means of ties.
ARTERIAL LINE: remove the red cap on the oxygenator
arterial outlet (fig.2, ref.3) in order to connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the
venous line and the oxygenator venous inlet connector (fig.2,
ref.4) taking account of the direction of rotation of the pump.
OXYGENATING MODULE PURGING /RECIRCULATION
LINE: connect the purging/recircualtion line end (fig.2, ref.5 -
1/4" connector) to the reservoir.
Check that the pos lock on the coronary outlet port is
closed (fig.2, ref.7).
If oxygenated blood is necessary, remove the red pos lock
and connect the 1/4" blood line of the cardioplegia circuit
to the D905 EOS ECMO coronary outlet port using the D
523C reduction (provided with the product).
The coronary outlet port has a self-sealing valve in order to
connect D 523C reduction also during extracorporeal bypass
without any leakage of fluid.
6) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red -fig.2,
GB – ENGLISH – INSTRUCTIONS FOR USE
device before use. Transport and/or storage conditions
other than those prescribed may have caused damage to
the device.
as contact may cause damage to the device.
– Do not allow halogenated liquids such as Halothane
and Fluothane to come into contact with the
polycarbonate housing of the device. This could cause
damage which may compromise the integrity and proper
function of the device.
may cause resistance inside the circuit and reduce the
efficiency of the heat exchanger.
cover as it is the outlet of the safety channel which
prevents contamination in the event of a seal failure.
not exceed 42 °C (108 °F).
exceed 300 KPa (3 bar / 44 psi).