Oxygen Concentrator

Trade name

Oxygen Concentrator

06970389630164

697038963FDOCNM

Reference / catalog number

FDOC6110

GS1

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The device works to use air as a raw material, and produces oxygen-enriched air using the molecular sieve PSA process, with a range of oxygen concentrations greater than or equal to 90% (V/V) at the recommended flow rate. It is suitable for oxygen therapy or for the relief of discomfort resulted from lack of oxygen

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12159004OXYGEN CONCENTRATORS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  1. During oxygen therapy, there is a risk of fire due to increased oxygen concentration. Do not use oxygen concentrators or accessories near sparks or open flames. 2. To ensure that the amount of oxygen needed for treatment is tailored to the patient's medical condition, the concentrator must be used only in one or more Settings that are individually prescribed for the patient's specific activity level."Combinations of specified components and accessories that conform to the manufacturer's specifications and are used after the Settings have been determined for the patient." 3. Only use oxygen-compatible water-based detergents or ointments before and during oxygen therapy. Never use petroleum or oil-based washes or ointments to avoid the risk of fire and burning. 4. The fittings, joints, pipes or other accessories of the oxygen concentrator should not be lubricated to avoid the risk of fire 5. Use only spare parts recommended by the manufacturer to ensure proper function and avoid the risk of fire 6. At altitudes above 1828 m, flow and oxygen content will be affected and the quality of treatment will be further affected. 7. Oxygen makes it easier to catch fire and spread it. Do not place a nasal oxygen tube or mask over a bed cover or a chair cushion when the oxygen concentrator is on and no one is receiving oxygen, because oxygen can easily ignite these materials. Oxygen concentrators should be turned off when not in use to avoid oxygen enrichment. 8. If you feel unwell or have a medical emergency during oxygen therapy, seek medical help immediately to avoid harm. 9. When the elderly, children or other patients are unable to express discomfort, additional monitoring measures or distributed alarm systems can be used to communicate discomfort information and medical emergencies to the responsible nursing staff to avoid harm