Priming And Recirculation Procedure; Initiating Bypass; During Bypass - SORIN GROUP dideco KIDS D100 Instrucciones Para El Uso

suitable air/oxygen mixer such as the Sechrist, code 09046 (available from SORIN
GROUP ITALIA) or a system with compatible technical features. A capnograph can be
connected to the "GAS ESCAPE" connector (fig. 1-2-3, ref. 4).
10) VAPOROUS ANAESTHESTICS
The oxygenator is suitable for use with volatile anaesthetic isoflurane and sevoflurane,
by mean of a suitable narcosis gas evaporator.
If these vaporous anaesthetics are used, some method of scavenging the gas from the
oxygenator should be considered.
The protocol, the concentration and the monitoring of the anaesthetic gases
administrated to the patient, is under the sole responsibility of the physician in
charge of the treatment.
The only volatile anaesthetics suitable for this use are isofluorane and sevolfuorane
The methods adopted for vaporous anaesthetic gas scavenging should not increase or
reduce in any way the pressure level at the oxygenator fibres.
- The "GAS ESCAPE" system is designed to avoid any possible risk of blocking the
gas outlet; such blockage could cause the immediate passage of air to the blood
compartment.
- Do not for any reason occlude the external access holes of gas compartment (fig.
1-2-3, ref. 4).
- SORIN GROUP ITALIA recommends the use of a bubble trap or filter on the arterial
line to reduce the risk of emboli transmission to the patient.
F. PRIMING AND RECIRCULATION PROCEDURE
Do not use alcoholic priming solutions: such solutions could compromise the proper
functioning of the oxygenating module.
1) KEEP THE GAS FLOW OFF
2) KEEP THE OXYGENATOR RECIRCULATION/PURGE LINE
CLOSED
Check that the clamp, placed on the oxygenator recirculation/purge line, is in closed.
3) SET THE VOLUME OF THE VENOUS RESERVOIR (fig. 2)
Version [B], only
Set the desired volume using the soft reservoir squeezer (ref. 16).
4) ISOLATE THE VENOUS RESERVOIR FROM THE OXYGENATING
MODULE
Clamp the cardiotomy outlet (Version [B] only), the venous return, the venous
reservoir outlet, and the arterial outlet of the oxygenator.
5) CHECK THE HEAT EXCHANGER
Verify again the integrity of the heat exchanger, with particular attention to possible
water leaks.
6) VENOUS RESERVOIR/ CARDIOTOMY PRIMING
Version [A] and [C] if in OPEN SYSTEM configuration
Secure with ties all aspiration lines connected to the venous reservoir. Fill the venous
reservoir with sufficient liquid to ensure the intended haematocrit is obtained, taking
into account:
- the static priming volume of the oxygenator is 31 ml;
- the 3/16" tube capacity is 19 ml/m;
- the 1/4" tube capacity is 32 ml/m.
Version [B] and [C] if in CLOSED SYSTEM configuration
Secure with ties all aspiration lines connected to the cardiotomy. Fill the cardiotomy
with sufficient liquid to ensure the intended haematocrit is obtained, taking into
account:
- the static priming volume of the oxygenator is 31 ml;
- integrated soft venous reservoir capacity varies from minimum 25 to maximum
90 ml;
- the 3/16" tube capacity is 19 ml/m;
- the 1/4" tube capacity is 32 ml/m.
7) CIRCUIT PRIMING
The pressure level inside the blood compartment of the oxygenating module shall not
exceed 100 Kpa (1 bar / 14 psi).
VERSION [B] and [C] if in CLOSED SYSTEM configuration
Remove the clamp at the cardiotomy outlet.
The priming solution flows to the soft venous reservoir. The air contained inside the
soft venous reservoir will automatically be evacuated from the purge line which is
placed at the top of the reservoir by activating the suction pump.
The pressure level inside the soft venous reservoir shall not exceed 13 KPa (0.13 bar /
1.9 psi).
All versions
Remove the clamp at the venous reservoir outlet.
Switch the arterial pump on to prime the oxygenating module, until approx half of the
oxygenating module is filled. Maximum flow shall not exceed 100 ml/min.
8) OPEN THE PURGING/ RECIRCULATION LINE
Once the steps up to and including point 7 have been carried out, open the clamp on
the purging/ recirculation line, and complete the priming of the oxygenating module.
In this condition blood recirculates from the module to the venous reservoir.
9) OPEN VENOUS AND ARTERIAL LINE
Remove the clamp from venous and arterial line and increase flow up to 700 ml/min.
10) PURGE THE AIR CONTAINED IN THE CIRCUIT
During this phase it is necessary to tap the entire circuit in order to facilitate the
removal of microbubbles from the tube walls. After some minutes in which the flow is
maintained at a high rate, all air will be removed.
11) PRIME OF THE SAMPLING SYSTEM
Priming of the A/V sampling system occurs automatically when the arterial, venous
and central stopcock handles are positioned towards the access ports of the manifold
to allow the prime to flow from the arterial outlet to the venous reservoir.
12) REDUCE ARTERIAL FLOW
After complete removal of air from the circuit, it is possible to reduce the arterial flow
to 200 ml/min to recirculate through the opened purging/recirculation line.
13) CLAMP THE VENOUS AND ARTERIAL LINES
Clamp the venous and arterial lines.
- During the priming and purge phases, the arterial/venous circuit must be
maintained at least 30 cm higher than the arterial outlet of the oxygenator.
- Do not use pulsatile flow during priming.
- SORIN GROUP ITALIA recommends the use of the pump speed control to reduce or
stop the arterial flow slowly.
- Do not use the pump on/off switch until the pump speed is zero.
- Do not turn the heater-cooler off.
- Check the correct dosage of anticoagulant in the system before starting the bypass.
- The user should carry out a gross inspection for air removal.
G. INITIATING BYPASS
1) OPEN THE ARTERIAL AND VENOUS LINES
Remove first the clamp from the arterial line, then remove the clamp on the venous
line. Start the bypass with a blood flow appropriate to patient size.
Check constantly the blood level in the Venous Reservoir.
2) CHECK THE CORRECT OPERATION OF THE HEAT
EXCHANGER
Check the temperature of the venous and arterial blood.
3) SELECTION OF THE APPROPRIATE GAS FLOW
The suggested gas/blood flow ratio in normothermia is 1:1 with a Fi0
- Always open the gas flow after the blood flow. . In case of pump stopping, turn off
the gas before stopping the blood flow.
- During bypass, the gas/blood flow ratio must never exceed 2:1. A phenomenon
called "wet lung" may occur when microporous hollow fibers oxygenators are used
for a long period of time. If water condensation associated with decrease of gas
exchange performance is noted during extended oxygenator use, increase the
gas/blood flow ratio up to 4:1.
- The pressure in the blood compartment must always exceed that of the gas
compartment. This is to prevent gas emboli appearing in the blood compartment.
- When the priming procedure is completed, make sure the gas flow is kept off for
the period of time before starting the procedure.
4) BLOOD GAS MONITORING
After a few minutes of bypass operation, measure gas content of the blood. Depending
on the values found, adjust the relevant parameters as follows:
High pO
2
Low pO
2
High pCO
2
Low pCO
2
H. DURING BYPASS
- During the procedure, when sequestering blood from the circuit (hemofiltration, blood
cardioplegia, sampling, ...) always make sure that the flow generated by the main
pump is higher that the blood flow sequestered. If not, the pressure in the blood
GB - ENGLISH
Decrease FiO
2
Increase FiO
2
Increase gas flow
Decrease gas flow
of 80:100%.
2
9