sorin dideco KIDS D130, Instructions For Use Manual

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4 GB - ENGLISH
•
Always apply and maintain a correct dose and accurate
monitoring of the anticoagulant before, during and after the
bypass.
•
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. 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,
currently SORIN GROUP ITALIA is not aware of any
contraindication to the use of systems having components
treated with Ph.I.S.I.O.
E. SET-UP
•
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 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.
Insert the D130/ D131 KIDS in the arterial line immediately before the
patient.
1) CIRCUIT CONNECTIONS
•
All connections and lines from the filter must be
secured by means of ties.
•
Always use a bypass line with the D130/ D131 KIDS.
1) Remove the caps from inlet and outlet connectors.
2) Connect the arterial line from the oxygenator to the filter inlet
connector (“IN” - fig. 1, ref. 1). Connect the filter outlet
connector (“OUT” - fig. 1, ref. 2) with the arterial line going to
the patient.
3) Perform filter bypass with a tube of the same dimensions as
the arterial line. Connect the bypass line before and after the
filter by means of two Y connectors.
2) POSITION THE D634 HOLDER
Position the D634 holder on pump structure by means of the
clamp at the upper end of the arm (fig. 2, ref. 1).
3) FIX THE ARTERIAL FILTER TO THE HOLDER
1) Insert the D130/ D131 KIDS in the appropriate clamp of the
D634 holder (fig. 2, ref. 2).
2) Secure the device in the holder by tightening the clamp knob
(fig. 2, ref. 3).
4) CONNECT THE PURGING LINE
1) Remove the double purging line from the sterile envelope
provided separately in the filter packaging.
Check that each line has a one-way valve and that this
valve is properly oriented along the line (allowing flow to
go from the arterial filter to the cardiotomy).
2) Remove luer cap from filter purge ports; screw the stopcock
luer connection at the free end of the blue purging line (fig. 3,
ref. 1) at the pre-filter female luer-lock (fig. 1 and fig. 2, ref.
A); screw the male luer-lock at the free end of the red
purging line to the post-filter female luer-lock ((fig. 1 and fig.
2, ref. B).
3) Prior to bypass, screw the luer connection of the stopcock
where the double purging line is connected (fig. 3, ref. 2) to
an unpressurized cardiotomy filtered luer port.
F. PRIMING PROCEDURE
The priming phase can be made easier by flushing the system
with filtered medical grade carbon dioxide prior to introducing
the perfusate. To this end, connect CO
2
line to the filter
purging connector for 5 minutes at a maximum flow of 5 l/min
and not exceeding the pressure 26 KPa (0.26 bar / 3.8 psi).
•
The pressure level inside the filter shall not exceed 100
Kpa (1 bar / 14 psi).
•
During perfusion place D130/ D131 KIDS vertically (to have
purge luers at the uppermost point).
•
During perfusion, in order to obtain the maximum removal
of gaseous emboli from blood, it is suggested to keep the
blue purging line (pre-filter) open and the red purging line
(post-filter) closed, after having evaluated the reduction of
the arterial flow due to the purging line opening (rif. Graph
2).
•
Close filter purge port prior to stopping the pump to
prevent blood/gas backflow into the filter.
See Fig. 3a
- Make sure the stopcock connected to the filter at the end of
the blue line (1) and the stopcock connected to the
cardiotomy with screwed the double purge line (2) are in
open position.
- Clamp inlet (A) and outlet (B) lines as nearest as possible
to the arterial filter.
- Start the pump and prime circuit and filter bypass line.
- Stop the pump.
See Fig. 3b
- Remove the clamp on inlet line (A) and move the clamp on
outlet line (B) to a point downstream of the outlet Y
connector (D).
- Start the pump and adjust flow to less than 100 ml/min.
- Continue until the filter is completely full.
- Gently tap the filter to remove any microbubbles.
See Fig. 3c
- Move the clamp on outlet line (B) to the bypass line (C).
- Increase the flow up to 700 ml/min (D131: 2500 ml/min).