Regulatory Status and Use Authorization The maximum FiO2 delivered by the Cube 25 NIV should be assumed to be 80% Oxygen supplementation to the mask only (without oxygen supply via nasal prongs) seems to be not suitable for the purpose of respiratory therapy in hypoxic patients.
Intended Use • The CUBE 25 NIV is a device for non-invasive, non-life supporting ventilation of spontaneously breathing patients who have a body weight of at least 13 kg and suffer from respiratory insufficiency. It is not intended to be a replacement for life supporting respiratory equipment.
Device Controls For further details refer to the User Manual Device Interfaces Doc. Ref.: ETION‐MED‐MDF‐01‐06‐08 (Rev 05)
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1. Ensure the therapy device is turned off. 2. Plug the AC adaptor into the Cube 25 NIV. Clamp the cord securely to the Cube 25 NIV enclosure. 3. Plug the AC adaptor into one of the clearly marked battery backed-up power sockets on the UPS unit.
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Monitor patient O2 saturation, FiO2 and CO2 - Refer to manufacturer instructions Respond to alarms as necessary 4. Connect to CUBE 25 NIV to test Audio pause will silence alarm for two minutes 5. Check unobstructed fl ow 10. Turn off second oxygen supply at end of therapy 11.
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Refer to the Clinical Guide for more information CUBE 25 NIV Settings for COVID-19 Treatment The Cube 25 NIV has been tested for the following modes using a breath rate of 12 bpm and 20 bpm : • CPAP – Refer to Oxygen fl ow rate vs Mean Airway Pressure (MAP) for FiO2 Estimation in CPAP mode as presented in the FiO2 Estimation diagram on page 9 of this document.
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Oxygen adaptor for secondary oxygen feed CCSC1963 Anaesthetic mask Size 3, 4 or 5 1514 or 1515 or 1516 Standard Oxygen tubing for secondary oxygen feed 1174000 UPS850LI Uninterruptable Power Supply (Not shown on image) CMS: Channels Medical Solutions Doc. Ref.: ETION‐MED‐MDF‐01‐06‐08 (Rev 05)
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Estimating FiO2 The maximum FiO2 delivered by the Cube 25 NIV should be assumed to be 80% Oxygen supplementation to the mask only (without oxygen supply via nasal prongs) seems to be not suitable for the purpose of respiratory therapy in hypoxic patients.
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5. Wipe off any excess disinfectant with a clean lint free cloth. 6. Connect the Cube 25 NIV to ResComf XD100 (or equivalent) for a period of 30 minutes. Replace coarse and fine filter with a new set before using it on the next patient.
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Immediately volume not reached maximum indicated inspiration should be checked. pressure. Press the Audio Pause button to silence the sound for two minutes while addressing the issue For further details refer to the User Manual Doc. Ref.: ETION‐MED‐MDF‐01‐06‐08 (Rev 05)
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Warranty ETION Create (Pty) Ltd, (“the Manufacturer”) warrants that the Cube 25 NIV In the event of the warranty becoming void as a result of an occurrence specified in paragraph 3a to 3d above, the Manufacturer will provide the Customer with (“the Goods”), exclusive of expendable parts and other accessories, shall be free...
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