Operation During Bypass; Terminating Bypass; Blood Recovery After Bypass; Use Of Active Venous Drainage With Vacuum - SORIN GROUP Dideco KIDS D101 Instrucciones Para El Uso

and arterial blood. Depending on the values found, adjust the relevant
parameters as follows:
High pO Decrease FiO
2
Low pO Increase FiO
2
High pCO Increase gas flow
2
Low pCO Decrease gas flow
2
H. OPERATION 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 compartment would
decrease causing the formation of air bubbles.
- Check that all luer connections are securely tightened. All accessory lines
connected to the device must be connected tightly and stopcocks must be
closed in order to prevent accidental introduction of air into the device or
blood loss.
1) CHECK THE VENOUS RETURN
If a higher venous return flow is necessary lower both the oxygenator and the
venous reservoir with respect to the patient position.
- The ACT (Activated Clotting Time) must always be longer than or equal
to 480 seconds in order to ensure adequate anticoagulation to the blood
circulating within the extracorporeal circuit.
- If administration of anticoagulant to the patient is envisaged, use the
luer connector of the central stopcock on the sampling manifold.
Version [A], OPEN SYSTEM
- The minimum operating volume in the venous reservoir is 30 ml.
However to ensure adequate response time in case of venous inflow
obstruction, it is recommended that an adequate volume in addition to
the 30 ml minimum level be maintained. Do not exceed 1500 ml in the
venous reservoir.
Version [B], OXYGENATING MODULE
- The Venous Reservoir must always be placed in a higher position in
respect to the oxygenator.
2) ARTERIAL SAMPLING
Insert a sample syringe into the arterial sample stopcock luer. Position the
stopcock handles toward the access ports of the manifold to allow arterial blood
to flow through the manifold. The pressure on the arterial side will allow flow.
Draw the sample of blood from the arterial sample stopcock. Turn off the arterial
stopcock before removing the syringe.
3) VENOUS SAMPLING
Ensure that the arterial stopcock is closed. Insert a sample syringe into the
venous stopcock luer and a flush syringe into the central stopcock luer. Open
the central stopcock and draw at least 10-15 ml of blood prior to taking the
venous sample. Close the central and the venous stopcock. Return this blood
through one of the filtered luer connectors positioned on the top of the reservoir.
Open the venous stopcock and draw a sample of venous blood. Close the
stopcock before removing the syringe.
4) DRUGS INJECTION
Insert the medication syringe into the luer connector of the central stopcock.
Open the central and venous stopcocks and inject the drug into the manifold and
venous sample line.
Close the central stopcock to the medication syringe and allow an arterial-
venous "wash" through the stopcock manifold. Turn the stopcocks to the closed
position when the drug has been delivered to the venous line.
Draw blood samples from the stopcocks only when the pump is running. If
not, the pressure in the blood compartment would decrease causing the
formation of air bubbles.
5) LOW FLOW RECIRCULATION
(Hypothermia associated with circulatory arrest or stand-by conditions).
a) Reduce the gas flow to less than 200 ml/min.
b) Open the clamp on the recirculation/purging line and clamp the venous
reservoir inlet line.
c) Reduce the flow from the arterial pump to 200 ml/min.
d) Clamp the oxygenator arterial line.
e) Recirculate at a maximum flow of 200 ml/min.
f) To re-initiate bypass open the venous and arterial lines and slowly increase
the blood flow.
g) Clamp the recirculation/purging line.
h) Adjust gas flow.
8
2
2
I. TERMINATING BYPASS
Bypass should be terminated after considering individual patient's clinical conditions.
Act as follows:
1) Turn the gas flow off.
2) Turn the heater-cooler off.
3) Slowly decrease the arterial flow to zero while closing the venous line.
4) Open the recirculation/purging line.
5) Clamp the arterial line.
6) Increase arterial flow to 200 ml/min.
- If extracorporeal circulation may be later restarted, a minimum blood flow
inside the D101 KIDS must be maintained (maximum 200 ml/min).
- If the use of the haemofilter is necessary, refer to its specific instructions for
use.
J. BLOOD RECOVERY AFTER BYPASS
1) Drain as much blood as possible from the venous line into the venous reservoir, as
soon as the surgeon has removed the venous cannulae from the patient. Slowly
return recovered blood to the patient by means of the arterial pump, as required
by the patient's condition.
2) If needed, blood in the oxygenator may also be returned by adding clear prime to
the venous reservoir when the blood in the reservoir has reached minimum
volume. Pump the priming solution slowly through the oxygenator ensuring that
the Venous Reservoir never empties.
3) When the Venous Reservoir is nearly empty stop the arterial pump and clamp the
arterial line.
K. USE OF ACTIVE VENOUS DRAINAGE WITH
VACUUM
Version [A], OPEN SYSTEM
This method may be applied at any time of the extracorporeal circulation, provided that
the prescriptions below are respected. Using the kit code 096834 or equivalent supplied
separately - and a vacuum regulation device, D101 KIDS may be used with active
venous drainage with vacuum. This technique constitutes an alternative to venous
drainage by gravity and improves venous drainage.
1. Open active venous drainage system kit. Maintain sterility of the system.
2. Connect the tubing end labelled "To Reservoir" to the vent connector of the
venous reservoir (ref. 16) and the tubing end labelled "To Vacuum" to the vacuum
regulating device.
3. Close the clamp on the line connected to the reservoir.
4. If considered necessary to interrupt or suspendactive venous drainage, open the
side line connected to the reservoir and remove the cap from it.
- A controlled vacuum regulating device is required.
- Always suspend vacuum when the main pump is stopped.
- Do not exceed -50 mmHg (-6.66 kPa / -0.07 bar / -0.97 psi) negative pressure in
venous reservoir. Higher level of vacuum increases the risk of hemolysis.
- Periodically check functioning of the vacuum regulating device and the degree
of vacuum.
L. OXYGENATOR CHANGE-OUT
A spare oxygenator must always be available during bypass in the unlikely event that
the oxygenator in use requires change-out. Procedures lasting longer than 6 hours or
particular situations where the safety of the patient may be compromised (insufficient
oxygenator performance, leaks, abnormal blood-gas parameters etc.), could require
change out. Follow the steps below to change out the oxygenator.
Use sterile technique during all replacement procedure.
1) Turn the gas flow off.
2) Double clamp the venous line (5 cm / 2 inches apart) next to the venous inlet port.
3) Reduce arterial pump blood flow to 200 ml/min.
4) Empty the venous reservoir.
5) Turn the arterial pump off and double clamp the arterial line (5 cm / 2 inches apart)
next to the arterial outlet port.
6) Double clamp the pump line next to the venous reservoir outlet.
7) Place a double clamp next to the oxygenator venous inlet.
8) Turn the heater-cooler off, clamp and remove the water lines.
9) Disconnect the gas line, all monitoring and sampling lines.
10) Cut all required lines in the section between the two clamps, leaving a sufficient
length of tubing to allow connection to the new oxygenator.
11) Remove the oxygenator from the holder.
12) Place a new oxygenator on the holder. Connect all lines (i.e. venous to the venous
reservoir inlet port, arterial and gas to the oxygenator, pump line to venous
reservoir outlet and oxygenator inlet port).
In this phase, keep the venous and arterial lines clamped.
GB - ENGLISH