dpv-ritmo

Nom de l'organisation

dpv-analytics GmbH

SRN

DE-MF-000007086

Statut du fabricant

Actif

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

Dénomination commerciale

dpv-ritmo

Code d'UDI-DI

42623841800064

Basic UDI-DI

B-42623841800064

Numéro de référence/catalogue

1.x.x

Entité d'attribution

GS1

Catégorie de risque

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The software dpv-ritmo is intended for use in the diagnosis of atrial fibrillation or atrial fibrillation episodes by means of automated evaluation of ECG waveforms recorded using a long-term ECG recorder (at least 1 channel, usually 3 channels). The recorder is attached to the sternal or left thoracic region by a patch. The recorded raw ECG data is transmitted to a central data center and processed by the machine learning software. The software evaluates the recorded curves for the presence of atrial fibrillation / absolute arrhythmia (paroxysmal atrial fibrillation, permanent atrial fibrillation) and uses a machine-learning algorithm. The result proposed by the automated evaluation can then be validated by a medical physician. The findings report is transmitted electronically to the sender of the ECG raw data. The indication for use is the diagnosis of atrial fibrillation or atrial fibrillation episodes. This is important in that atrial fibrillation is a major predictor of thromboembolic strokes. A substantial proportion of patients with atrial fibrillation or atrial fibrillation episodes are symptom-free. The target group of patients is initially the adult population to allow a substantial screening regarding atrial fibrillation. The patient group can be adapted to risk factors. Here the ChadVascScore can be consulted.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Z12059009ECG DATA MANAGEMENT SYSTEMS

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

Ce dispositif n'est actuellement lié à aucun autre dispositif.