ANI Guardian Device

Nom de l'organisation

PPRS

SRN

FR-MF-000013227

Statut du fabricant

Actif

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

• CW010

  EUDAMED n'a pas publié de description pour ce code.
• CW007

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

  Do NOT open, tamper with nor modify the device
• CW999

  Do NOT under any circumstance charge the device while it is being worn
• CW999

  Do NOT use the device in case of allergy to one of its components
• CW999

  Do NOT wear the device over a wounded or unclean skin
• CW999

  Do NOT place the device in contact with water under any circumstance, be it cleaning or otherwise
• CW999

  Do NOT tighten the textile armband too much

Marché principal en France ; disponible dans 1 pays au total.

Dénomination commerciale

ANI Guardian Device

Code d'UDI-DI

37700248000360

Basic UDI-DI

3770024800ANIGuardian6Y

Numéro de référence/catalogue

3770024800ANIGuardian6Y

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

ANI Guardian Device responds to the need to record and monitor in a simplified way the state of well-being / pain of patients with little or no communication. ANI Guardian is intended to measure in an ambulatory fashion the pain and well-being of different categories of patients. It is composed of a recorder that measures the wearer’s heart rate from their pulse as well as their arm movements during the night. The device is designed to put the sensor window in contact with the subject’s forearm, thanks to an armband that holds the device. The ANI Guardian Device transmits, via Bluetooth Low Energy, an estimation of the R-R intervals of the patient, based on the measure of the P-P intervals. The heart rate (R-R intervals) estimated by ANI Guardian cannot be used for diagnosis purposes. It should be noted that the recorded data by ANI Guardian Device can be used for ANI score calculation. ANI Guardian can be used in a healthcare professional setting (hospital) or at home. The ANI Guardian Device is worn on the upper-forearm and composed of an electronic hardware within a textile armband.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• C900399CARDIOVASCULAR SENSORS - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel