CARDIOSKIN™

Context

Pathologies for which the 2017 ISHNE-HRS expert consensus recommends the conduction of long-term ambulatory ECG1:

SYNCOPE / PALPITATIONS  / ATRIAL FIBRILLATION / CORONARY ISCHEMIA / DILATED CARDIOMYOPATHY / HYPERTROPHIC CARDIOMYOPATHY / INHERITED ARRHYTHMIC DISEASES

Atrial fibrillation1

4 weeks vs 24h

X7

Syncope2

1-4 weeks vs 48h**

X7

Palpitations2

1-4 weeks vs 24-48h**

X6

Cryptogenic stoke

1-4 weeks vs 24-48h***

X6

1) Steinberg JS, et al. Heart Rhythm, 2017;14(7)
2) Brignole M, et al. Eur Heart J. 2018; 39(21): 1883-1948
** 1-4 weeks vs 24-48 hours, based on the estimated midrange diagnostic rates of a normally distributed dataset.

CardioskinTM Medical Objectives

Wireless and wearable medical device. Cardioskin™ enables the acquisition, recording, storage, transmission and display of a 15-lead ECG in order to analyse potential cardiac pathological abnormalities.

Cardioskin™ main objectives are to:

  • Provide support to healthcare professionals in the monitoring and the analysis of their patients’ electrocardiographic signals to identify pathological abnormalities;
  • Allow long-term ECG recording sessions;
  • Enable patients to report events during an on-going recording session.
Objectifs médicaux Cardioskin

How does Cardioskin™ work?

CARDIOSKIN™
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CARDIOSKIN™ TEXTILE

Close-fitting unisex t-shirt, featuring patented material and embedded textile electrodes for 15-lead ECG data

  • Available in 5 sizes
  • Machine washable
CARDIOSKIN™

CARDIOSKIN™ RECORDER

Records the patient’s ECG data up to 14 day

  • Attaches to the Cardioskin™ Textile with snap buttons
  • Flat and flexible, designed to adapt to the body’s movements
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CARDIOSKIN™

CARDIOSKIN™ BATTERIES AND USB CABLE

Powers the Cardioskin™ Recorder

  • Attaches to the Cardioskin™ Textile with snap buttons
  • Up to 30 hours of autonomy per battery
  • 4 LEDs to indicate the battery level
  • Rechargeable (1 to 2 hours for a full battery recharge)
  • USB type C cable (plugs into any conventional USB charger-plug)
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CARDIOSKIN™

CARDIOSKIN™ DOCK

The dock is a power supply device that enables the data transfer from the recorder to the cloud database through a Wi-Fi connection

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CARDIOSKIN™

CARDIOSKIN™ CLOUD

Used to prescribe, collect and analyse patients’ ECG data

  • Secured online platform available 24/7
  • ECG data analysis software
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CARDIOSKIN™

CARDIOSKIN™ APP

Used to launch and monitor recordings

  • HCPs: Select ECG recordings via Bluetooth
  • Patients: Launch recordings from their smartphone. Flag events during the ECG recording. Check signal quality for each of the electrodes
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Mandatory notices

The Cardioskin™ is a wearable and wireless medical device, which allows acquisition, recording, storage, transmission and displaying of electrocardiogram (ECG).
For more information, please refer to the user manual, available on demand.
You can also contact WeHealth™ Digital Medicine or your local representative, if you have one.
EU: Cardioskin™ is a class IIa CE marked medical device.
US: Cardioskin™ has US FDA 510(k) clearance as class II medical device (510(K) Number: K173248).
Cardioskin™ is a trademark of Biofarma.

The pictures are not contractuals.