AE-8-S

Dénomination commerciale

non renseigné

06922546700135

692254670014FJ

Numéro de référence/catalogue

AE-8-S

GS1

Classe IIb

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Medical Oxygen Concentrator is a mobile oxygen Concentrator which can both be used in various settings including medical institutions and home. It utilizes the Pressure Swing Adsorption technology, and zeolite molecular sieve as the absorbent, the sieve could separate oxygen from nitrogen and other gases in the air, and provide 90 – 96% concentration of oxygen to the patients.

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.

• 1.The product is used for oxygen supplement, not for life support or life extension, not for first-aid purpose, and it is suggested that when using the device the patient’s oxygen flow and inhalation time shall be set according to doctor’s guidance. The oxygen delivery setting has to be determined for each patient individually with the configuration of the equipment to be used, including accessories. 2.The therapeutic effectiveness of the prescribed oxygen flow setting should be periodically reassessed. 3.If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm. 4.Additional indicating equipment should be provided when severe-ill patents use this product. And if any adverse reaction happens to the patients, please inform their doctor immediately. 5.There is a risk of fire associated with oxygen enrichment during oxygen therapy. Do not use the oxygen concentrator or accessories near sparks or open flames. 6.Open flames during oxygen therapy are dangerous and is likely to result in fire or death. Do not allow open flames within 2 m of the oxygen concentrator or any oxygen carrying accessories. In addition the device is only for indoor use. 7.Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death. Do not allow smoking within the same room where the oxygen concentrator or any oxygen carrying accessories are located.(If you intend to smoke, you must always turn the oxygen concentrator off, remove the cannula and leave the room where either the cannula or mask or the oxygen concentrator is located. If unable to leave the room, you must wait 10 minutes after you have turned the oxygen concentrator off before smoking. 8.Please do not place the oxygen concentrator in any area near strong magnetic field or electromagnetic interference source.

  AUTRE