dpv-ritmo

Organization name

dpv-analytics GmbH

SRN

DE-MF-000007086

Manufacturer status

Active

Primary placement in Germany; available across 1 country total.

Trade name

dpv-ritmo

UDI-DI code

42623841800064

Basic UDI-DI

B-42623841800064

Reference / catalog number

1.x.x

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12059009ECG DATA MANAGEMENT SYSTEMS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

This device is not currently linked to any other device.