dideco VANGUARD D921 Instrucciones Para El Uso página 4

0°C
32°F
The following are items of general information about safety,
intended to provide the operator of the set with appropriate war-
nings. In addition, specific information about safety is included
in these instructions for use where they may affect the opera-
tion to be performed.
CAUTION
- The device must be used in accordance with these instruc-
tions for use.
- The device is intended for professional use.
- SORIN GROUP ITALIA accepts no responsibility for
problems caused by negligence or improper use.
- FRAGILE: handle with care
- Do not expose to temperatures below 0°C (32°F) or over
60°C (140°F).
- Do not exceed a inlet water pressure of 552 kPA (5 bar / 70 psi).
- Do not exceed a heat exchanger inlet water temperature of
42°C (108°F).
- Protect from humidity.
- For use once only and on a single patient.
- 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. If the device is
supplied NON STERILE (in which case the pack will be
marked "non sterile"), reach agreement on the sterilisation
method with SORIN GROUP ITALIA or its authorised
representative.
- It is recommended that a cold agglutinin test be performed
with the patient's blood before using the set. The tempera-
ture of cardioplegic solution should not be lower than the
cold agglutination temperature if the test shows the cold
2
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
CAUTION
- 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
Keep away from heat
60°C
140°F
Temperature limitation
0°C (32°F) ÷ 60°C (140°F)
Keep dry
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 condi-
tions 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 polycarbo-
nate 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 exchan-
ger for a few minutes; the structure is guaranteed undama-
ged if there are absolutely no leaks from the water compart-
ment.
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 con-
tainers.
6) CONNECT THE BLOOD LINE
Connect the blood line to the coronary outlet (1/4") of the
oxygenator; this connection must always be made before pri-
ming the oxygenator.
7) CONNECT THE DELIVERY LINE
Connect the delivery line, ensuring sterility: the end with luer-
lock connector will connect to coronary access cannula.
F. PRIMING PROCEDURE
CAUTION
- 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,