What is the intended use and how is the device to be used?
pack attached to its shoulder bag
The emOx Emergency Powdered Oxygen system is intended to generate 99.7%
pure oxygen for emergency first aid administration, prior to
emOx is a lightweight, portable device that produces oxygen of greater
than 99.7% purity by means of a chemical reaction. This reaction is
initiated by pouring approximately 450ml of tap water into a 3-liter
polypropylene cylinder into which 300grams of sodium percarbonate and 7
grams of manganese catalyst have been placed. A water chamber located in
the neck of the cylinder, into which 50 ml of tap water is poured,
humidifies the oxygen as it bubbles through the water on its way through
the tapered orifice in the polycarbonate cap of the cylinder. A length of
flexible ribbed PVC tubing connects the cylinder to a facemask for
delivery of oxygen to the patient.
b) Is the device
intended to contact the patient or other persons?
between the patient and the device is only by means of the facemask, which
has a 1.5 meter length of flexible ribbed PVC tubing connects the cylinder
to a facemask for delivery of the oxygen to the
c) Is energy delivered to and / or extracted
from the patient?
No energy is delivered or extracted from
d) Are substances delivered to and / or
extracted from the patient?
Yes, oxygen is delivered to the
patient by means of oxygen supply from the device. The oxygen purity is in
excess of 99.7%.
e) Is the device supplied sterile or
intended to be sterilized by the user or are other microbiological
Only the facial oxygen mask and tubeing is sterile
f) Is the device intended to modify
the patient environment?
The device’s intended use is in
emergency situations only until professional help is
g) Are measurements
h) Is the device
Symbolized instructions are printed on the
green cylinder. An instruction leaflet is also provided.
i) Is the device intended to control or to interact
with other devices or drugs?
The device only provides
j) Are there unwanted outputs of energy or
Due to the chemical reaction the green cylinder
gets hot, and it is suggested that it be maintained in the carry bag when
in use. (Refer to the Instructions on the Green Cylinder – Cylinder
generates heat when in use.)
The chemical residue produced is
k) Is the device susceptible
to environmental influences?
The storage of the chemicals
should be at room temperature to ensure indefinite shelf life.
event of the sodium percarbonate coming into contact with skin or eyes,
rinse the affected area with water. If irritation persists medical advice
should be sought.
In the case of accidental ingestion medical advice
should be sought.
If chemicals are accidentally spilled, rinse area with water to reduce
the percarbonate (white ) powder to a harmless
l) Are there essential consumables or
accessories associated with the device?
m) Is maintenance and / or calibration
No maintenance is required, as there are no mechanical or moving
n) Does the device contain
o) Does the device have a
restricted “shelf life”?
No. The powders have an indefinite
shelf life if stored at room temperature.
delayed and / or long term use effects?
What determines the lifetime of the device?
As the device is
made up of different types of plastic (e.g. polypropylene, polycarbonate)
the device will have a lifetime as to the durability of these plastics.
The lifetime of the powders are indefinite.
r) Is the
device intended for single use or re-use?