the operator in 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 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.
- Do not expose to temperatures below 0°C (32°F) or above
60°C (140°F).
- Keep dry.
-
Always give and maintain a correct dose and accurate moni-
toring 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 clin-
ical 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 spe-
cific 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 indi-
cated by the wording "NOT STERILE" on the pack) contact
SORIN GROUP ITALIA or an authorised dealer to agree on a
sterilisation method.
- The EOS venous reservoir, applying the method of active
venous drainage with vacuum, must be used carefully follow-
ing the instructions “USE OF ACTIVE VENOUS DRAINAGE
WITH VACUUM” in this user manual in paragraph K.
- The special positive and negative pressure relief valve
installed on the EOS cardiotomy/venous reservoir ensures
optimum post-operative performance: it operates to vent pos-
itive pressures above 0,7 KPa (0.007 bar/0.1 psi) and negative
pressures lower than -10 KPa (-0.1 bar/-1.5 psi). Do not plug
the external vent of this valve for any reason.
- 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.
- Inner surfaces of the system are Ph.I.S.I.O. coated; SORIN
GROUP ITALIA is currently not aware of any contraindication to
the use of systems having components treated with Ph.I.S.I.O.
E. SET UP
1) POSITION THE HOLDER
Position the D 905 EOS holder D632 on the pump structure by
means of the clamp at the upper end of the arm.
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.
Remove the device from the sterile packaging.
- Carry out a visual inspection and carefully check the device
before use. Transport and/or storage conditions other than
those prescribed may have caused damage to the device.
- 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 contact with the polycarbonate
housing of the device. This could cause damage which may
compromise the integrity and proper functioning of the
device.
Fix the D 905 EOS onto the holder.
The word "OPEN" on the water connectors locking system must
be visible.
Check that the notches on the water connectors locking system
are aligned.
Only then you can fix the oxygenator onto the holder.
Insert the Hansen connectors and push D 905 EOS down to the
holder and turn the locking lever on “CLOSED” position.
The D 905 EOS will be correctly positioned only when the lock-
ing lever shows "CLOSED".
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the oxy module by means of the
female Hansen connectors SORIN GROUP ITALIA code 09028.
- The use of different connectors from those indicated may
cause resistance inside the circuit and reduce the efficien-
cy of the heat exchanger.
- Do not obstruct the hole on the heat exchanger lower cover
situated near the venous temperature probe. This hole con-
nects the safety channel which helps prevent fluids crossing
from one compartment to the other.
- 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
300 KPa (3 bar / 44 psi).
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the heat
exchanger for a few minutes. The integrity of the unit is guaran-
teed if there are absolutely no leaks from the water compartment
or from the safety channel hole.
5) CIRCUIT CONNECTIONS
- All connections downstream of the pump must be secured
by means of ties.
- Remove the yellow cap from the vent connector (fig. 2, rif.
18) of the Cardiotomy Reservoir.
- Remove the yellow insert from the pressure relief valve (fig.
2, rif. 17)
VENOUS LINE: Connect a venous line of 1/2" to the connector
indicated on the venous reservoir as "VENOUS RETURN" (fig.2,
ref.13).
The Venous Return connector can be rotated 180° to find the
most convenient position of the venous tubing. This rotation is
possible only after removing the polycarbonate insert that fixes
the connector.
2
ENGLISH
CAUTION
WARNING
WARNING
WARNING
WARNING
WARNING
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