Priming And Recirculation Procedure - SORIN GROUP D905 EOS Instrucciones Para El Uso

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.
- 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
function of the device.
Place the D905 EOS MODULE on the holder jaw (fig. 1, ref. 2).
3) THERMOCIRCULATOR SET UP
Connect the water tubes to the holder by means of the female Hansen
connectors SORIN GROUP ITALIA code 9028.
- The use of different connectors from those indicated may cause
resistance inside the circuit and reduce the efficiency of the heat
exchanger.
- Do not occlude the hole on the heat exchanger bottom cover as it is
the outlet of the safety channel which prevents contamination in the
event of a seal failure.
- The water temperature at the heat exchanger inlet must not exceed
42 °C (108 °F).
- The water pressure in the heat exchanger must not exceed 300 KPa
(3 bar / 44 psi).
4) CHECK THE HEAT EXCHANGER
Check the heat exchanger by recirculating water inside the heat exchanger
for a few minutes. The integrity of the housing is guaranteed if there are
absolutely no leaks from the water compartment or from the outlet hole of the
safety channel.
5) CIRCUIT CONNECTIONS
All connections downstream of the pump must be secured by means of
ties.
ARTERIAL LINE: remove the red cap on the oxygenator arterial outlet (fig. 2,
ref. 3) in order to connect a 3/8" line.
PUMP LINE: the pump segment should be set up between the venous
reservoir outlet connector and the oxygenator venous inlet connector (fig. 2,
ref. 4) taking account of the direction of rotation of the pump.
OXYGENATING MODULE PURGING /RECIRCULATION LINE: connect the
purging/recircualtion line end (fig. 2, ref. 5 - 1/4" connector) to the
recirculation line inlet on the soft venous reservoir (closed system); otherwise
to the venous inlet of the rigid venous reservoir (open system).
ARTERIAL SAMPLING LINE: remove the protective cap from the connector
located near the arterial outlet and connect the male luer of an arterial
sampling line (fig. 2, ref. 6).
Male luers not supplied with SORIN GROUP ITALIA products may
damage the one-way valve placed inside the oxygenator arterial
sampling luer. When connecting, make a visual check that the male luer
does not reach as far as the one-way valve.
Check that the pos lock on the coronary outlet port is closed (fig. 2, ref.
7). If oxygenated blood is necessary for blood cardioplegia, remove the
red pos lock and connect the 1/4" blood line of the cardioplegia circuit
to the D905 EOS MODULE coronary outlet port using the D 523C
reduction (provided with the product).
The coronary outlet port has a self-sealing valve in order to connect D 523C
reduction also during extracorporeal bypass without any leakage of fluid.
6) CONNECT THE TEMPERATURE PROBES
The connection for the arterial temperature probe (red -fig. 2, ref. 8) is
positioned next to the arterial outlet, while the venous probe site (blue - fig. 2,
ref. 9) is at the side of the venous inlet. SORIN GROUP ITALIA temperature
probes have the code 9026.
7) CLOSE THE RECIRCULATION LINE
4
Close the purging-recirculation stopcock (refer to the diagram on the label)
(fig. 2, ref. 10).
8) CONNECT THE GAS LINE
Remove the green cap from the connector labelled "GAS INLET" (fig. 2, ref.
11) and connect the 1/4" gas line. The gas should be supplied by a suitable
air/oxygen mixer such as the Bird code 9374 (available from SORIN GROUP
ITALIA) or a system with compatible technical features. A capnograph
connector can be found in the centre of the "GAS ESCAPE" connector (fig. 2,
ref. 12).
- 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.
- 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 PURGING/RECIRCULATION
LINE CLOSED
Check that the purging-recirculation stopcock is closed (fig. 2, ref. 10).
3) CLOSE THE VENOUS AND ARTERIAL LINES
Clamp the venous line coming from the patient. Clamp the arterial line some
centimetres from the arterial outlet. When using a soft venous reservoir
(closed system), clamp the line between the auxiliary cardiotomy and the soft
venous reservoir. When using a rigid venous reservoir (open system), clamp
the rigid venous reservoir outlet.
4) CHECK THE HEAT EXCHANGER
Verify again the integrity of the heat exchanger, with particular attention for
possible water leaks.
5) CARDIOTOMY/HARDSHELL VENOUS RESERVOIR
PRIMING
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 recovered priming volume of the oxygenator is 160 ml;
- the 3/8" tube capacity is 72 ml/m;
- the 1/2" tube capacity is 127 ml/m.
When using a soft venous reservoir (closed system), open the auxiliary
cardiotomy outlet to fill the soft venous reservoir.
Operate the aspiration line to purge air from the soft venous reservoir.
6) CIRCUIT PRIMING
- The pressure level inside the blood compartment of the oxygenating
module shall not exceed 100 KPa (1 bar / 14 PSI).
- The pressure difference between blood compartment inlet and outlet
at maximum blood flow shall not exceed 40 kPa (0,4 bar / 5,8 PSI).
Remove the pump segment from the arterial pump head.
Prime the pump segment by holding it at the cardiotomy height and slowly
open the clamp. Lower the line slowly to direct air to the oxygenator. The
oxygenating module priming is completed by gravity. When the D905 EOS
MODULE is primed, insert the pump segment in the arterial pump.
7) OPEN VENOUS AND ARTERIAL LINES
Remove the clamp from the venous and arterial lines and increase flow up to
2000 ml/min.
8) OPEN THE PURGING/RECIRCULATION STOPCOCK
Once the steps up to and including point 7 have been carried out, increase
the arterial pump speed until the flow reaches the maximum value of 5.0
l/min.
Open the purging recirculation stopcock for some seconds in order to prime
the oxygenator recirculation line.
9) PURGE THE AIR FROM 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 evacuated.
10) CLOSE THE PURGING/RECIRCULATION LINE
GB – ENGLISH