Terminating Bypass; Blood Recovery After Bypass; Use Of Active Venous Drainage With Vacuum; Oxygenator Change-Out - SORIN GROUP dideco KIDS D100 Instrucciones Para El Uso

compartment would decrease causing the formation of air bubbles.
- Check the security of all luer connections. 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 act as follows:
Version [B], CLOSED SYSTEM
a) Open completely the soft reservoir squeezer in order to increase the reservoir
volume.
All versions
b) Lower both the oxygenator and the venous reservoir with respect to the patient
position.
- The ACT (Activated Coagulation Time) must always be longer than or equal to 480
seconds in order to ensure adequate anticoagulation of 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 10 ml. However to
ensure adequate response time in case of venous inflow obstruction, it is
recommended that an adequate volume in addition to the 10 ml minimum level be
maintained. Do not exceed 500 ml in the venous reservoir.
Version [B], CLOSED SYSTEM
- The cardiotomy must always be placed in a higher position with respect to the soft
venous reservoir.
- It is recommended to keep the line connecting cardiotomy and soft venous
reservoir clamped during the case, in order to prevent massive air delivery to the
patient in case the cardiotomy and the soft venous reservoirs empty. In case blood
has to be moved from the cardiotomy to the soft venous reservoir, carefully open
the clamp and avoid to empty the line connecting cardiotomy and soft venous
reservoir. Emptying the cardiotomy and the soft venous reservoir might result in air
delivery to the oxygenator and, eventually, to the patient.
Version [C], OXYGENATING MODULE
- The Venous Reservoir must always be placed in a higher position than 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 center stopcock. Open the center stopcock
and draw at least 10-15 ml of blood prior to taking the venous sample. Close the
center 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 and 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).
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 throughout the patient's circulatory
arrest.
f) To initiate bypass after circulatory arrest, open the venous and arterial lines and
slowly increase the blood flow.
g) Clamp the recirculation/purging line.
h) Adjust gas flow.
I.

TERMINATING BYPASS

Bypass should only be terminated after consideration of each individual patient's state. Act as
10
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 has to be restarted subsequently, a minimum blood flow
inside the D100 KIDS must be maintained (maximum 200 ml/min).
- If the use of the haemofilter is necessary, refer to its specific instructions for use.
VERSION [B], CLOSED SYSTEM
In case of insufficient venous return flow the soft venous reservoir might collapse.
If this happens, consequent negative pressure might cause gas extraction from the blood if
the arterial pump is not stopped immediately. To eliminate air from the soft venous reservoir,
proceed as follows:
1) Turn the gas flow off.
2) Turn the arterial pump off.
3) Clamp the arterial line.
4) Restore the required volume of liquid in the soft venous reservoir (by releasing the soft
venous reservoir squeezer or by adding liquids).
5) Check for the absence of air bubbles in the soft venous reservoir.
6) Clamp the venous line.
7) Open the recirculation/purging line and recirculate at a rate of 200 ml/min until complete
air removal from the system.
8) Restart bypass by opening the arterial and venous lines.
9) Clamp the recirculation/purging line.
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 it 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 (Version [B]: to the cardiotomy reservoir) when the blood in the
reservoir as reached minimum volume. Pump the prime slowly through the oxygenator
ensuring that the Venous Reservoir never is emptied.
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, D100 KIDS may be used with active venous
drainage with vacuum. This technique constitutes an alternative to venous drainage by gravity
and improves venous drainage during minimally invasive surgical techniques or regular
bypass surgery.
1) Open active venous drainage system kit. Maintain sterility of the system.
2) Connect the end with the blue cap to the vent connector of the venous reservoir (fig. 1,
ref. 16) and the end with the red cap to the vacuum regulating device.
3) Close the clamp and the green cap on the line connected to the reservoir.
4) If considered necessary to interrupt or suspend this method, remove the yellow cap and
open the clamp on the line.
- 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 if
particular situations where the safety of the patient may be compromised (insufficient
oxygenator performance, leaks, abnormal blood parameters etc.), could require change out.
Follow the steps below to change out the oxygenator.
Use sterile methods during all replacement procedure.
1) Turn the gas flow off.
2) Double clamp the venous line (5 centimetres apart).
Version [B], CLOSED SYSTEM
3) Close, by means of a double clamp, the output line of the cardiotomy and add
appropriate liquids to the cardiotomy to prime the new oxygenator.
GB - ENGLISH