ONIRY Probe

Dénomination commerciale

ONIRY Probe

05905567844706

59055678447002ZK

Numéro de référence/catalogue

002

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 ONIRY Probe, along with the ONIRY Spectrometer, is intended for rapid detection of obstetric anal sphincter injuries in postpartum period utilizing machine learning-assisted impedance spectroscopy method. The probe is a disposable device that works with the ONIRY Spectrometer. The product is intended for use only by health professionals within the environment of specialist medical care. Patient target group is women in the postpartum period following vaginal delivery.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

1 niveau de conditionnement enregistré — chaque niveau porte son propre IUD-ID.

• 05905567844706× 1 unitéUnité de base
  • 05905567844720× 50 unités

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

• U0899GYNAECOLOGICAL DEVICES - OTHER

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

• - Any implants in the pelvic area - Major malformations affecting the perianal area - Coincident connection with electronic medical or surgical equipment or device generating alternating current above 1 kHz Warnings - As diagnostic performance of ONIRY has not been specifically studied in patients with: - active inflammatory bowel disease affecting the perianal area fever, the diagnostic performance is uncertain in such conditions - The ONIRY device should not be used directly after administration of an anal suppository or other anally administered drug or cosmetic - The ONIRY Probe electrodes contain nickel - Although no actual or potential safety concern is identified for patients with an implanted cardiac device (e.g., pacemaker) or other electronic implant, further advice on usage of ONIRY may be sought from the treating cardiologist/physician or implant manufacturer Precautions - ONIRY device must not be used beyond the expiry date marked on the package - ONIRY Probe is a disposable product intended for a single patient and should not be re-used - ONIRY Probe is a disinfected product. Additional disinfection or cleaning before use is not recommended - ONIRY Probe must not be used if the package is damaged - ONIRY Probe must not be used if it gets visibly soiled after unpacking - ONIRY device must not be used in the vicinity of: · devices generating microwaves · devices generating strong electromagnetic field as this may result in a device operation instability. - ONIRY Spectrometer may only be used with the ONIRY Probe as well as the accessories (i.e., charger) recommended by the manufacturer and included in the set. - Chemical cleaners must not be used to clean the ONIRY Spectrometer.

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