Assembly; Priming Procedure - SORIN GROUP Vanguard D921 Instrucciones Para El Uso

- 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
- Do not subject to further treatments.
- Do not resterilize.
- After use, dispose of the device in accordance with the applicable
regulations in the country of use.
- The device must only be used if STERILE.
- It is recommended that a cold agglutinin test be performed with the patient's
blood before using the set. The temperature of cardioplegic solution should
not be lower than the cold agglutination temperature if the test shows the
cold agglutinin to be haemolytic.
- Do not allow the cardioplegic solution bags to empty completely.
- When used in conjunction with membrane oxygenators, to avoid
introducing air into the circuit:
- do not start cardioplegia pump until arterial pump is on
- do not stop arterial pump until cardioplegia pump is off
- arterial pump flow must always exceed cardioplegia pump flow.
- For further information and/or in case of complaint, contact SORIN GROUP
ITALIA or your local authorised representative.
E. ASSEMBLY
- The cardioplegia sets must be installed before priming the extracorporeal
tubing system and the air venting procedure must be carried out before
extracorporeal circulation begins.
- The heat exchanger must be in a vertical position to avoid entry of air into
the patient delivery line.
- Sterility is guaranteed provided the sterile pack has not been wet, opened,
tampered with or damaged.
Do not use the device if sterility is not guaranteed.
- Check the shelf-life expiry date on the label provided. Do not use the device
after this date.
- The device must be used immediately after the sterile pack is opened.
- The device must be handled in an aseptic manner.
- Make a visual check on the device and inspect it carefully before use.
Inappropriate transport and/or storage conditions may have damaged the
product.
- Do not use solvents such as alcohol, ether, acetone etc.; they may damage
the product on contact.
- Do not allow halogenated liquids such as Halothane or Fluothane to come
into contact with the device's polycarbonate structure. This would cause
damage which might impair the device's operation.
1) FIX THE BCD HEAT EXCHANGER TO THE HOLDER AND
CONNECT TO THE THERMOCIRCULATOR
Remove the set from its sterile pack. Place the BCD heat exchanger in the
holder D 610. Connect the heat exchanger to the thermocirculator using the
SORIN GROUP ITALIA female Hansen connectors code 9028 at the "Water
in" and "Water out" ports.
2) CHECK THE HEAT EXCHANGER
The BCD is checked by circulating water through the exchanger for a few
minutes; the structure is guaranteed undamaged if there are absolutely no
leaks from the water compartment.
3) OTHER CONNECTIONS
Connect the line with the transducer protector to a pressure gauge using one
of the two three-way stopcocks.
Connect the other three-way stopcock to the luer vent port at the top of the
heat exchanger.
Connect a mod. 9026 probe or equivalent model Y.S.I. series 400 compatible
probe to the BCD VANGUARD temperature port. Version with D924S and
D928S
Connect a stopcock to the luer-lock connector of the blood line if access is
required during use.
4) INSTALL LINES IN THE PUMP
Install the blood and cardioplegic lines in the roller pump head, making sure
that the lines are fitted in such a way that the flow direction is towards the "Y"
fitting. The pump should be equipped with the correct tube clamping inserts.
5) CONNECT THE CARDIOPLEGIC SOLUTION LINE
Connect the cardioplegic solution lines to the solution containers.
6) CONNECT THE BLOOD LINE
Connect the blood line to the coronary outlet (1/4") of the oxygenator; this
4
connection must always be made before priming the oxygenator.
7) CONNECT THE DELIVERY LINE
Connect the delivery line, ensuring sterility: the end with luerlock connector
will connect to coronary access cannula.
F. PRIMING PROCEDURE
- Always make sure that the arterial pump is running before operating the
cardioplegia pump, to ensure no air is extracted from the oxygenator.
1) PRIMING THE CIRCUIT
Close the outlet line.
Ensure that the pump remains completely clamped until ready for use and
then start the priming of the blood line, with cardioplegic solution coming from
the oxygenator, and of the asanguineous solution line through the pump.
- Failure to prime the VANGUARD beyond the cardioplegia pump head
can result in air being introduced into the arterial line of the
oxygenator.
Version D924S AND D928S
Prime the blood line using physiological solution coming from the oxygenator,
open the shunt between the blood line and the asanguineous cardioplegic
solution line and start priming through the pump. Close the asanguineous
solution line.
2) VENT THE AIR FROM THE HEAT EXCHANGER
Prime the cardioplegic solution lines and the blood line by running pump at
50 ml/min. Fill the heat exchanger completely then close the vent stopcock.
Then open the stopcock on the pressure monitoring line to atmosphere.
Open the outline.
- Failure to release the solution line clamp when the solution reaches
the top of the device can rerult in an anomalous pressure increase
which may cause the pressure relief valve to activate.
3) VENT THE AIR FROM THE DELIVERY LINE
Open the patient delivery line. Restart the pump slowly while directing the air
out of the delivery line. When priming is complete, clamp the line again. The
surgeon can now make the connection to the coronary access cannula
prepared and then vent the air from it.
G. DELIVERY PROCEDURE
Version BCDVAN4S ANDBCDVAN96ù
Open the asanguineous solution line.
1) Switch on the thermocirculator one minute before cardioplegia delivery begins.
Start pump to deliver cardioplegic solution to the patient. Adjust pump speed to
obtain the desired flow and pressure values.
2) Costantly monitor the procedure so that the blood level in the oxygenator
venous reservoir and the quantity and quality of the liquid in the asanguineous
cardioplegic solution container are always under control.
3) To administer further doses check that there is no air in the circuit and repeat
the procedure described in points 1. And 2.
- Failure to discontinue water flow may result in cold agglutination when cold
cardioplegic solution is used.
Version BCDVAN4S and BCDVANS
If administration of blood only is indicated:
- stop the pump
- open the shunt between the blood line and the asanguineous cardioplegic
solution line
- clamp the asanguineous cardioplegic solutÏtion line
- start the pump.
- Check carefully that the pressure is within the recommended range;
different pressure values may lead to inadequate perfusion or damage to the
coronaries.
- The line pressure is not the same as the perfusion pressure since it
depends on the resistance of the delivery line connectors and cannula. The
actual perfusion pressure is generally lower than the reading.
- The pressure inside the heat exchanger must absolutely never exceed 98
kPa (0,98 bar/psi).
- Keep a constant check on the temperature of the cardioplegia solution; this
temperature will depend on the flow of the cardioplegic solution, the
temperature of the cooling water, the blood and cardioplegic solution.
- Monitor the cardioplegic delivery in terms of quantity, time, pressure and
GB - ENGLISH