Intended Use; Safety Instructions; Warnings Overview - GCE Zen-O RS-00500 Manual Del Usuario

Intended Use

2 .
Zen-O™ portable oxygen concentrator is intended to provide supplemental oxygen to patients
with chronic pulmonary diseases and any patient requiring supplemental oxygen.
The device is portable, enabling patients who need an oxygen device to be treated at home
according to a clinician's prescription or direction.
Zen-O™ is not intended for use in life supporting or life sustaining situations, and is provided
non-sterile. It is a prescription only device, and designed for indoor and outdoor use. For cor-
rect operational conditions see Chapter 14. Technical Description.
Zen-O™ Portable Oxygen Concentrator is not intended to be used:
EN
• in life-supporting or life-sustaining situations
• in an operating or surgical environment
• with a non-adult population
• in conjunction with flammable anaesthetic or flammable materials

Safety Instructions

3 .

Warnings Overview

3.1.
1. The device must be used in the carry bag to provide protection from liquid intrusion
from rain and/or spills.
2. There is a risk of fire associated with oxygen equipment and therapy. Do not use near
sparks or open flames.
3. The settings of Zen-O™ Portable Oxygen Concentrator RS-00500 might not correspond
with continuous flow oxygen.
4. The settings of other models or brands of portable oxygen concentrators do not corre-
spond with the settings of Zen-O™ Portable Oxygen Concentrator RS-00500.
5. Wind or strong drafts can adversely affect accurate delivery of oxygen therapy.
6. Geriatrics or any other patient unable to communicate discomfort can require addition-
al monitoring to avoid harm.
7. Smoking (including e-cigarettes) during oxygen therapy is dangerous and is likely to
result in facial burns, serious injury or death of the patient and others from fire. Do not
allow smoking or open flames within the same room as the portable oxygen concentra-
tor or any oxygen carrying accessories. If you smoke, you must always turn the oxygen
concentrator off, remove the cannula and leave the room where either the cannula or
the concentrator is located. If unable to leave the room, you must wait 10 minutes after
the flow of oxygen has been stopped.
8. Use only water based lotions that are oxygen compatible, before and during oxygen
therapy. Never use petroleum or oil based lotions or salves when operating the device
to avoid the risk of fire and burns.
9. Open flames during oxygen therapy are dangerous and are likely to result in fire or
death. Do not allow open flames within 2 metres of the oxygen concentrator or any
oxygen carrying accessory.
10. Oxygen makes it easier for a fire to start and spread. Do not leave the nasal cannula on
bed coverings or chair cushions with the concentrator on, but not in use; the oxygen will
make the materials flammable. Turn the concentrator off when not in use to prevent
oxygen enrichment.
11. Critical! Explosion hazard. Do not use in the presence of flammable anaesthetics!
12. Do not use this device in the presence of pollutants or fumes.
13. Do not submerge this device in liquid. Do not expose to water or precipitation. Do not
expose to dusty conditions.
14. Do not use a device or any accessory that shows any sign of damage.
15. Do not use lubricants on this device or any of its accessories.
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