I
2
Doc. Ref.: ETION-MED-MDF-01-06-08 (Rev 02)
CUBE 25 NIV
The Cube 25 is manufactured in
South Africa under license from
JFR Medical Instruments.
It is functionally equivalent to the
CUBE 30 and can be used for
emergency treatment during the
COVID-19 Pandemic.
This ventilator (CUBE 25 NIV)
is not registered by the
Authority and is only
authorized for emergency use
during the Covid-19
pandemic.
Decommissioning and Disposal
•
The device is designed with lifetime of five years.
•
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.
Regulatory Status and Use Authorization
The maximum FiO
2
delivered by the Cube 25 NIV is 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.
WARNING