Preparation And Setup - sorin SYNTHESIS 4D Instrucciones De Uso

- For use by professionally trained personnel only.
- SORIN GROUP ITALIA is not responsible for problems arising
from inexperience or improper use.
- Do not use the device if it has been cracked, dropped or
otherwise physically damaged.
- FRAGILE. Handle with care.
- Keep dry. Store at room temperature.
- Always apply and maintain a correct dose and accurate
monitoring of the anticoagulant before, during and after the
bypass.
- Do not use the SYNTHESIS 4D for a period longer than 6 hours.
The system has not been qualified through in vivo, ex vivo, or
clinical studies for long term use (longer than 6 hours) as a
bridge to transplant, or for pending recovery of the natural heart
or for extracorporeal circulation (ECMO), The use of the device
may result in pump failure, reduced priming capability,
excessive blood trauma, degradation and/or corrosion of blood
contacting materials with the consequent possibility of particles
passing through the bypass circuit to the patient, leaks, and
increased potential for gaseous emboli entering the arterial line.
- 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 at the end of use.
Therefore, reuse on other patients might cause cross-
contamination, infection and sepsis. In addition, reuse
increases the probability of product failure (integrity,
functionality and clinical effectiveness).
- The device must not undergo any further processing.
- Do not resterilize.
- 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.
- The device contains phthalates. Considering the nature of
body contact, the limited contact duration and the number of
treatments per each patient, the amount of phthalates which
might be released from the device do not raise specific
concerns about residual risks. Further information is
available on request from Sorin Group Italia.
- 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 2250
mmHg (300 kPa / 3 bar / 44 psi).
- Do not allow the blood side pressure to exceed 750 mmHg (1
bar/ 100 kPa / 14.5 psi).
- Do not allow the pressure on the blood side of the membrane to
fall below the pressure on the gas side of the membrane. Blood
compartment pressure must always be maintained higher than
gas compartment pressure to prevent formation of gas emboli in
the blood compartment.
- SYNTHESIS 4D should always be placed at a level not higher
than the patient.
- Ensure that the flow of the main pump is always greater than that
of the cardioplegia or haemoconcentration pump. In any event, the
flow of the cardioplegia line must never exceed 1 l/min.
- Avoid occluding, even accidentally, of the gas outlet line: any
over-pressurization of the gas compartment may generate
micro-emboli in the blood compartment.
- Check the patency of the gas circuit by circulating gas in the
circuit. If the gas circuit is occluded, replace the oxygenator.
- Arrange the surgical cannula in such a way that air is not aspirated
into the venous line.
- Do not ventilate the SYNTHESIS 4D while the arterial and venous
lines are clamped, as this can cause evaporation of prime
solution across the microporous membrane and result in air in
the arterial line.
- Prevent that halogenated liquids such as halothane and
fluothane come into contact with the polycarbonate structure
of the device. This would cause damage which would
compromise the integrity and functionality of the device.
- When using the SYNTHESIS
postoperative thoracic drainage, carefully follow the instructions
in paragraph M "POSTOPERATIVE DRAINAGE" provided in this
document.
- Do not for any reason separate the gas module/heat
exchanger/arterial filter/pump from the venous reservoir. Only
perform this operation if the venous reservoir is to be used for
postoperative thoracic drainage and only when extracorporeal
circulation has been terminated.
- Do not separate the SYNTHESIS 4D modules in order to place
the gas module at a level or position different from its original
configuration at the time of opening the sterile package.
- When using the SYNTHESIS 4D venous reservoir applying the
6
4D venous reservoir as
GB – ENGLISH
method of active venous drainage with vacuum, carefully follow
the instructions in paragraph L "USE OF ACTIVE VENOUS
DRAINAGE WITH VACUUM" in this user manual.
- The special positive and negative overpressure valve mounted on
the SYNTHESIS 4D venous
postoperative functioning of the system: it starts operating and
releases positive pressures above 5 mmHg (0.7 kPa / 0.007 bar/0.1
psi) and negative pressures below –80 mmHg (–10,4 kPa / -0.10
bar/-1,53 psi). Do not for any reason occlude the external access
hole of pressure relief valve. Remove tab inserted in pressure
relief valve from the valve prior to use.
- The vent cap must be removed in order to prevent inadvertent
pressurization of the reservoir.
- The vent must be open at all times during the operation of the
reservoir or be attached to a regulated vacuum source not to
exceed -50 mmHg (-6,66 kPa / -0,07 bar / -0,97 psi) in procedures
using vacuum assisted venous return.
- Obstruction of the vent port may result in pressurization of the
reservoir and potentially gaseous air bubbles passing air emboli
to the patient and/or damage to the device.
- Do not allow the venous reservoir to become pressurized as this
could obstruct venous drainage, force air retrograde into the
patient, or cause air to enter the blood path of the oxygenator.
- SYNTHESIS 4D may only be used with the appropriate HOLDER.
- For further information and/or in case of complaints 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.
- Do not operate the pump unprimed. Doing so may damage the
pump.
- To aid in the prevention of gas or particulate embolization,
SORIN GROUP ITALIA recommends the use of safety devices,
including bubble sensors and pre-bypass filters, for all
procedures using the SYNTHESIS 4D.
- Entry of massive air into the pump will cause the device to
deprime and the blood flow to stop.
- The pump must not be run unattended.
- Inner surfaces of the system are Ph.I.S.I.O. coated, currently
SORIN GROUP ITALIA is not aware of any contraindication to
use of systems having components treated with Ph.I.S.I.O.
E. PREPARATION AND SETUP
1) POSITIONING THE HOLDER
Position the SYNTHESIS 4D HOLDER on a pole and fix it by means of
the clamp behind the load bearing "arch." Be sure to orient the holder
such that the device will be upright, and check that there is sufficient
.
space for the pump driver
2) FIXING THE DEVICE ON THE HOLDER
- Do not use if sterile packaging is damaged, unsealed, or has been
exposed to moisture or other conditions that would compromise
the sterility of the device.
- Check the expiry date on the label. Do not use the device after
this date.
- The device must be used immediately after opening the sterile
packaging.
- The device must be handled aseptically.
Remove the device from the sterile packaging.
- Visually inspect and carefully check the device before use.
Transport and/or storage
prescribed may have caused damage to the device.
- Particularly, turn the device upside down and verify the
integrity of the four fins connecting the arterial filter to the
oxygenating module.
- 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 SYNTHESIS 4D oxygenator onto the holder. Check that the
water connector locking lever is in the "OPEN" position. Make sure
that the water connectors of the oxygenator are aligned with the
Hansen connectors of the holder. Insert the oxygenator Hansen
connectors and push SYNTHESIS 4D down into the holder.
Turn the locking lever to the "CLOSED" position.
Slide the pump driver into place and secure it to the pump head of
SYNTHESIS 4D. Verify that the centrifugal pump is correctly engaged
with the pump driver locking tab
reservoir assures perfect
conditions other than
.
Close the support collar around the
those