CELLINA

Dénomination commerciale

CELLINA

08800071900009

88000719CEL-DMB8

Numéro de référence/catalogue

DC-1

GS1

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Treatment of axillary hyperhidrosis and Fractional Radio Frequency based device. Fractional Microneedle Radio Frequency (FMR) Cellina delivers energy to the deep dermis through isolated micro needles without destroying the epidermis. Assuming that FMR energy can affect skin surface retention and sweat secretion even then the glands reach the deep dermis, FMR treatment is effective in treating axillary hyperhidrosis without serious side effects.

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.

• Z12010905RADIOSURGICAL UNITS

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW999

   Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.  If you have not used the device for certain period of time, make sure all functions are properly operating before applying it to a patient.  Securely connect all component.  Check if there is any sign for breakage or malfunction.  Operator shall set up the device depending on conditions of the patient and affected area.  Continuous operation over 30 minutes may cause overload. 5 minutes of break recommended every 30 minutes of operation.  Make sure power supply cable is not twisted. Twist of power supply cable might cause overheat.  Do not step on, load weights or impact on power supply cable.  Use the device in an environment free of strong electromagnetic field.  In the event of black out, disconnect power supply cable and return the articulated arm to normal position.  After use, power cable and articulated arm shall properly fastened to prevent stumble or bruise and remove the key switch to prevent unauthorized use.  Clean the device by whipping with a cloth moistened with neutral detergent. Be careful not to let liquid penetrate into the device.  Informed the patient that unexpected movement might cause tissue damage. It is crucial that the patient communicate to the operator about the pain he/she is feeling, so the operator can pause or cease operation at appropriate time.