The pack attached to its shoulder bag | a) What is the intended use and how is the device to be used? The emOx Emergency Powdered Oxygen system is intended to generate 99.7% pure oxygen for emergency first aid administration, prior to
receiving professional assistance.. 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?
The contact 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 patient.
c) Is energy delivered to and / or extracted from the patient?
No energy is delivered or extracted from patient
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 controls applicable?
Only the facial oxygen mask and tubeing is sterile and disposable.
f) Is the device intended to modify the patient environment?
The device’s intended use is in emergency situations only until professional help is available.
g) Are measurements made?
No.
h) Is the device interpretative?
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 oxygen.
j) Are there unwanted outputs of energy or substances?
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 environmentally accepted.
k) Is the device susceptible to environmental influences?
The storage of the chemicals should be at room temperature to ensure indefinite shelf life.
In the 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 substance.
l) Are there essential consumables or accessories associated with the device?
Not Applicable.
m) Is maintenance and / or calibration necessary? No maintenance is required, as there are no mechanical or moving parts.
n) Does the device contain software?
No.
o) Does the device have a restricted “shelf life”?
No. The powders have an indefinite shelf life if stored at room temperature.
p) Possible delayed and / or long term use effects?
No
q) 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?
For Re-use | 
emOx Emergency Oxygen
