Oxygen Concentrator

Dénomination commerciale

Oxygen Concentrator

06970389630720

697038963FDOCNM

Numéro de référence/catalogue

FDOC6905

GS1

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Z12159004OXYGEN CONCENTRATORS

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• 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