Device Use And Removal; Removing The Device; Device Replacement - Spectrum Quantum PureFlow Instrucciones De Uso

G.2. REMOVING AIR BUBBLES
CAUTION
- Do not use inappropriate tools to remove any air bubbles, as they may damage the device and alter its opera� on.
1. Open the purge line.
2. Remove the air by circulating solution inside the circuit at a flow of 100-150 ml/min.
3. Verify the air removal.
4. Close the purge line.
5. Verify that all the air bubbles have been removed from the circuit.
6. Stop the pump and clamp the device outlet line.
H.

DEVICE USE AND REMOVAL

CAUTION
- To reduce the risk of air reaching the pa� ent, make sure that the device and the circuit are free of air and check that they have been
fi lled properly before star� ng the procedure.
- Visually check that all the air has been removed from the device.
- Carefully check for the absence of poten� al occlusions in the circuit before star� ng perfusion with cardioplegic solu� on.
- In case of leaks or other faults, remove the device in accordance with what is indicated in these instruc� ons for use.
- Prolonged use of the device with sta� onary fl ow may cause the forma� on of clots or agglu� na� on.
- If the device is used for blood cardioplegia and it is fi � ed downstream of the membrane oxygenator, make sure that the cardioplegic
perfusion fl ow is always lower than that of systemic perfusion.
- Check that all the Luer-lock connec� ons are secure.
- All accessory lines connected to the device must be perfectly herme� cally sealed.
H.1. USING THE DEVICE DURING THE PROCEDURE
1. Let the HTF circulate at the desired temperature.
2. Remove the clamp from the device outlet line.
3. Start the cardioplegia pump at the desired flow rate.
4. Check the temperature and pressure of the cardioplegic solution by means of the sensor integrated in the device.
5. Repeat the operations (see steps 2, 3 and 4) each time you need to administer cardioplegic solution.
H.2.

REMOVING THE DEVICE

CAUTION
- Remove and dispose of the device a� er each procedure in accordance with what is indicated in sec� on A. Follow the instruc� ons given
in sec� on K if used devices need to be returned.
1. Once perfusion is complete, stop the cardioplegia pump.
2. Empty the HTF circuit following the instructions reported in the user manual of the Spectrum Medical Quantum Heater-Cooler System.
3. Disconnect the tubes of the Spectrum Medical Quantum Heater-Cooler System heat transfer circuit.
4. Disconnect the temperature probe.
5. Remove the device from the cardioplegia circuit.
I.

DEVICE REPLACEMENT

CAUTION
A� er six hours of use with perfusion fl uid or if situa� ons occur that, based on the judgement of the person responsible for perfusion,
compromise the safety condi� ons for the pa� ent (insuffi cient performance, loss of integrity of the HTF compartment or the cardioplegic
solu� on compartment, etc.), proceed as follows to replace the device.
- If the device needs to be replaced during circulatory support, evaluate the poten� al risks for the pa� ent before replacing the device.
- Never disconnect the lines if the circuit is pressurized.
- Visually inspect and carefully check the device before replacing it.
- Handle the device asep� cally throughout the replacement procedure.
- Follow the instruc� ons given in sec� on K if the device needs to be returned.
1. Empty the HTF circuit following the instructions reported in the user manual of the Spectrum Medical Quantum Heater-Cooler System.
2. Disconnect the tubes of the Spectrum Medical Quantum Heater-Cooler System.
3. Remove the new device from the outer packaging and from the sterile packaging checking its integrity.
4. Stop the cardioplegia pump following the instructions in the user manual of the Spectrum Medical Quantum HLM heart-lung machine
(Quantum Pump Console User Guide).
5. Place two clamps on both the cardioplegic solution inlet and outlet line of the device.
6. Disconnect the temperature probe.
7. Clamp the overpressure valve purge line and remove it.
Instruc� ons for use
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