Set-Up; Priming Procedure - sorin Micro Mode D'emploi

The following is general safety information with the aim of advising 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 only be used if STERILE.
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.
Keep dry. Store at room temperature.
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
Inner surfaces of the system are Ph.I.S.I.O. coated;
SORIN GROUP ITALIA is currently not aware of any
contraindication to
components treated with Ph.I.S.I.O.
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.
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
(FIG. 2)
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.
4
the use of systems
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 MICRO filter in the arterial line immediately before the
patient.
All connections and lines from the filter must be secured by
means of ties.
Always use a bypass line with the MICRO filter.
1. Remove red caps from inlet and outlet connectors.
2. Connect the arterial line from the oxygenator to the filter inlet
connector (BLOOD INLET). Connect the filter outlet connector
(BLOOD OUTLET) 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.
4. Secure the device in the suitable SORIN GROUP ITALIA holder
available in the following versions:
D 713 Adult MICRO Holder (fig. 8)
D 624 Infant-Newborn MICRO Holder (fig. 10)
The supports consist of:
- a clamp (ref. a) with a knob (ref. b) to be connected to the
pump pole (ref. c);
- an expansion terminal (ref. d) (Adult versions) or a fork-like
terminal
Terminals are interchangeable.
- a flexible arm to position the filter.
having
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 CO2 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).
5. Remove the purging line from the sterile envelope provided
separately in the filter packaging.
Carry out a visual inspection and carefully check the
product before use.
6. Remove luer cap from filter purge port and attach to it the
stopcock luer connector on the purge line.
7. Prior to bypass, connect purge line free end to an unpressurized
cardiotomy filtered luer port.
F. PRIMING PROCEDURE
During perfusion place MICRO filter vertically (to have purge
luer at the uppermost point).
During perfusion set purge line stopcock open to obtain the
maximum removal of gaseous emboli from blood.
Close filter purge port prior to stopping the pump to prevent
blood/gas backflow into the filter.
See figure 1
- Clamp inlet (A) and outlet (B) lines as nearest as possible to the
arterial filter. Close the stopcock on the filter purge line.
- Prime circuit and filter by-pass line.
- Stop the pump.
See figure 2
- Move the outlet line (B) to a point downstream of the outlet Y
connector(D).
- Open stopcock on the purge line.
(Infant-Newborn version) to fit filter housing.