Medical Devices To Be Used With The Device; Return Of Used Devices And Notifications - Spectrum Quantum PureFlow Instrucciones De Uso

8. Clamp the purge line and remove it.
9. Remove the device from the dedicated Spectrum Medical holder.
10. Cut the inlet and outlet lines at the point between the two clamps taking care to keep adequate lengths for reconnection.
11. Discard the device to be replaced.
12. Position the new device on the dedicated Spectrum Medical holder.
13. Fill the HTF compartment of the heat exchanger as described in section F.2 and check its integrity as described in section F.3.
14. Start the Spectrum Medical Quantum Heater-Cooler System.
15. Connect the cardioplegic solution inlet line to the cardioplegic solution inlet connector and the cardioplegic solution outlet line
to the cardioplegic solution outlet connector of the new device.
16. Use cable-ties to externally lock the inlet and outlet tubes on the respective connectors of the device.
17. Connect the purge line to the new device.
18. Connect the overpressure valve purge line to the new device.
19. Connect the temperature probe.
20. Fill the device carrying out the operations described in section G.
21. Check that there is no air in the device.
22. If there is air in the device, follow the instructions given in section G.2.
23. Open the outlet line only after having checked that there is no air in the device.
24. Open the outlet line.
25. Resume perfusion.
J.

MEDICAL DEVICES TO BE USED WITH THE DEVICE

CAUTION
- The user must respect the warnings and precau� ons and follow the instruc� ons for use provided with the device.
- The connec� ons of the circuit in which the cardioplegic solu� on circulates must be made using tubes of a diameter compa� ble with
the dimensions of the connectors on the device in accordance with Table 1 - sec� on D.
- The temperature must be monitored with a YSI 400 compa� ble probe.
The device is qualifi ed to be used exclusively with:
 Spectrum Medical Quantum Heater-Cooler System.
 Spectrum Medical Quantum HLM heart-lung machine and accessories.
K.

RETURN OF USED DEVICES AND NOTIFICATIONS

CAUTION
- Always keep any defec� ve medical devices. Follow the instruc� ons below if the devices need to be sent for inves� ga� on.
- Healthcare ins� tu� ons are responsible for preparing and iden� fying the products for return shipments. If the product to be returned
has been in contact with the pa� ent's blood, it must be treated, packed and handled in compliance with the provisions of the legisla� on
in force in the country where the product has been used. Do not send products that have been contaminated by infec� ous pathogenic
agents.
- Qura stresses the importance of repor� ng any incident that occurred regarding the device to Qura and to the competent authority
of the Member State where the product was used. Should the user be dissa� sfi ed with anything related to the quality of the product,
the user may no� fy Qura or the distributor of the Qura product. All no� fi ca� ons considered cri� cal by the user must be reported with
par� cular care and urgency. Below is the minimum informa� on to be provided:
 thorough description of the event and, if pertinent, the conditions of the patient;
 identification of the product involved;
 batch number of the product involved;
 availability of the product involved;
 all the indications the user considers useful in order to understand the origin of the dissatisfaction.
- Qura reserves the right to authorize the return of the product involved in the no� fi ca� on for assessments.
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Instruc� ons for use
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