Preparation And Setup - sorin SYNERGY Ph.I.S.I.O Gebrauchsanweisung

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.
- Do not use the SYNERGY 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.
- SYNERGY is a closed loop, active venous drainage system
and does not include a venous reservoir. Care must be taken
to strictly monitor the pump rpm, delivery flow rate and
circuit/patient pressures such that, in case of massive blood
loss or slow blood loss, the pump can be adjusted
accordingly.
- This device is intended for one-time, single patient use only.
Do not resterilize.
- Do not strike the device, as excessive shock may cause
damage to the device and cause device malfunction.
- Ensure that SYNERGY is completely primed and de-aired
before proceeding with bypass.
- The SYNERGY is a closed loop, kinetically-assisted drainage
system. It is therefore mandatory that the utmost care be taken
to avoid the accidental introduction of air into the system.
- High vacuum pressures can be generated in the venous line
due to cannulae manipulation/movement, flow obstructions
including kinking of the venous line, etc. It is highly
recommended that the negative pressure at the inlet of the
SYNERGY be monitored in order to avoid situations of
excessive negative pressure at the venous inlet of the device.
It is imperative that the maximum allowable negative pressure
limit of –100 mmHg in the venous line is never exceeded. If the
venous inlet pressure exceeds this limit, reduce the pump flow
rate, then identify and resolve the problem creating the high
negative pressure.
- High vacuum pressures can be generated based on cannulae
diameter selection. A minimum venous cannula diameter of 28
French is recommended in order to reduce the risk of
generating high vacuum pressures in the venous line.
- Do not operate the pump with the centrifugal pump inlet
clamped. A negative pressure would be generated in the pump
and air bubbles could form.
- The use of the Sorin Group Deutschland Stöckert Electric
Remote Clamp (ERC) and a bubble sensor with SYNERGY is
highly recommended.
- 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 (100
kPa).
- Do not use additives or disinfectants, such as bleach, in the
heater/cooler while the SYNERGY is connected to the heater
cooler.
- 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.
- SYNERGY should always be placed at a level not higher than the
patient.
- Ensure that pump flow rate is always greater than cardioplegia
and/or haemoconcentration
cardioplegia delivery flow
cardioplegia device maximum rated flow rate.
6
flow rates. In any event,
rate must not exceed
- Avoid occluding, even accidentally, 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.
- SYNERGY can only be used with the appropriate holder.
- Do not ventilate the SYNERGY 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.
- 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 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 SYNERGY.
- 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 SET-UP
1) HOLDER SET-UP
Position the holder on a pole and fix it by means of the fast clamp
connector. 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) MOUNTING
HOLDER
Do not use if the 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 conditions other than those
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 SYNERGY 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 SYNERGY
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 SYNERGY. Verify that the centrifugal pump is correctly
engaged with the pump driver locking tab. Close the support
collar around the pump driver.
Only when the locking lever shows "CLOSED" the oxygenator is
correctly inserted in the holder.
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GB – ENGLISH
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