ETION CREATE CHANNELS MEDICAL SOLUTONS CUBE 25 NIV Setup Manual
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ETION CREATE CHANNELS MEDICAL SOLUTONS CUBE 25 NIV Setup Manual

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CUBE 25 NIV
COVID-19 setup guide

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Summary of Contents for ETION CREATE CHANNELS MEDICAL SOLUTONS CUBE 25 NIV

  • Page 1 CUBE 25 NIV COVID-19 setup guide...

  • Page 2: Decommissioning And Disposal

    • Authorization is only provided for emergency use during the COVID-19 pandemic. • Etion Create intends to register a CE Mark of the CUBE 25 NIV and shall inform customers as and when this will be available. • Please contact your supplier after 31 March 2021 for expanded application/ clinical indication information, instructions for disposal or product update options.

  • Page 3: Intended Use

    Intended Use 1. 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.

  • Page 4: Device Controls

    Device Controls Start/Stop For further details refer to the User Manual Device Interfaces Doc. Ref.: ETION-MED-MDF-01-06-08 (Rev 02)
  • Page 5 Connecting the device to UPS 1. Ensure the therapy device is turned off. 2. Plug in the AC adaptor into the Cube 25 NIV. Clamp the cord securely to the Cube 25 NIV enclosure. 3. Plug the AC adaptor into the one of the clearly marked battery backed-up power sockets on the UPS unit.
  • Page 6 Clinical Workflows Treatment Initial setup by Physician 14. Place nasal prongs in patient nostrils and start 4. Decide on treatment mode administration of oxygen at 10L/min 5. Select clinical mode 15. With nasal prongs in situ, place the mask on 6.
  • Page 7 Selecting Therapy Modes and Therapy Sets CAUTION A physician must set the correct therapy. 25. CPAP A physician is required to select the therapy mode and program the parameters in Clinical 26. PSV-S / Bilevel S mode. 27. PCV Bilevel T Maximum two therapy sets can be programmed.
  • Page 8 Mask Patient Circuit Setup Mask Breathing Circuit Component List Item Supplier Part number Standard Oxygen tubing with Nasal Prongs RCNC1161 Breathing tube system, Ø 22 mm, 1.80 m P001Z002 Included with CUBE 25 Straight connector 22M - 6mm OD stem and 1963000 cap - 22F (with cap removed to ensure leak) Bacterial / Viral filter –...
  • Page 9 Oxygen Enrichment Measurements The maximum FiO delivered by the Cube 25 NIV is 80% Oxygen supplementation to the mask only (without oxygen supply via nasal prongs) WARNING seems to be not suitable for the purpose of respiratory therapy in hypoxic patients. Oxygen must be administered under the supervision of a physician Do not use if damaged CAUTION...
  • Page 10 Alarms (1/3) Audible and visible alarms indicate various fault conditions. High priority The result of a high-priority alarm can be the death or irreversible injury to the patient. This is shown in the device display by three red triangles. An acoustic signal also sounds Moderate priority The result of a moderate-priority alarm can be reversible injury to the patient.
  • Page 11 Alarms (3/3) Priority Acoustic Cause Trigger Resolution Display The respiratory minute volume The patient’s condition Moderate Low minute volume c a f 10 sec is lower than the set limit value. should be checked. The respiratory rate exceeds The patient’s condition High respiratory rate 5 sec the set limit value.
  • Page 12 CUBE 25 NIV Service, Maintenance and Repair If the device is used without Bacterial/Viral filter or contamination is suspected, contamination disinfection protocol shall be followed. Contact supplier for instructions. Never use if damaged. WARNING Interval Activity Components Breathing device When patient changed Disinfect the device surfaces CUBE 25 NIV When patient changed...

  • Page 13: Warranty

    Warranty ETION Create (Pty) Ltd, (“the Manufacturer”) warrants that the Cube 25 NIV (“the Goods”), exclusive of expendable parts and other accessories, shall be free from defects in material and workmanship for a period of 12 (twelve) months from the original date of delivery, and shall conform to its specification at the time of delivery.
  • Page 14 Authors: Jaco Botha and Sanet Groenewald Contributors: Andre van Tonder Andre Ten Napel Björn Kleinschmidt Jaco Basson Date: 2020-10-14 Doc Ref.: ETION-MED-MDF-01-06-08 (Rev 02) Doc. Ref.: ETION-MED-MDF-01-06-08 (Rev 02)

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