CardioskinTM solution overview

Innovative connected ECG solution for long-term monitoring and data analysis.

CardioskinTM presentation

 

CardioskinTM is an innovative connected solution for long-term ECG monitoring and data analysis that allows continuous recording.

It combines a smart textile, a smarthphone App, a Cloud platform and electronic components.

Indications

 

CardioskinTM is an innovative connected solution for long-term ECG monitoring.

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

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

Syncope2
1-4 weeks vs 48h**

Palpitations2
1-4 weeks vs 24-48h**

Cryptogenic stoke2
1-4 weeks vs 24-48h**

Current practice

In practice

  • Few minutes at 24h: Rest / stress ECG

 

Ambulatory

  • 24h at 48h: Holter & Event recorder
  • 48h at 2 weeks: Long-term ECG. CardioskinTM is an ECG solution, designed to maximize the change of diagnosing ECG abnormalities through long-term monitoring
  • 2 weeks at several months: implementable Cardiac Monitoring device

How does CardioskinTM work?

 

CardioskinTM is an innovative connected solution for long-term ECG monitoring. It combines a smart textile, a smarthphone App, a cloud platform and electronic components.

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™ 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.

CARDIOSKIN™ CLOUD

Used to prescribe, collect and analyse patients’ ECG data

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

CARDIOSKIN™ DOCK

Allows to transfer ECG data from the recorder to the Cardioskin™ Cloud via WiFi for complete upload

  • Plugs into main power source

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)

CARDIOSKIN™ RECORDER

Records the patient’s ECG data up to 14 days

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

How does CardioskinTM work?

 

CARDIOSKIN™ RECORDER

Records the patient’s ECG data up to 14 days.

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

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)

CARDIOSKIN™ DOCK

Allows to transfer ECG data from the recorder to the Cardioskin™ Cloud via WiFi for complete upload

  • Plugs into main power source
  • Connects to the Cardioskin™ Cloud through WiFi

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™ APP

Used to launch and monitor recordings

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

CARDIOSKIN™ CLOUD

Used to prescribe, collect and analyse patients’ ECG data

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

References

 

CardioskinTM textiles, available sizes

  • 1005-00011-EU – Unisex S41 – underbreast measurement from 66 cm to 71 cm
  • 1005-00012-EU – Unisex S42 – underbreast measurement from 71 cm to 83 cm
  • 1005-00013-EU – Unisex S43 – underbreast measurement from 83 cm to 96 cm
  • 1005-00014-EU – Unisex S44 – underbreast measurement from 96 cm to 112 cm
  • 1005-00015-EU – Unisex S45 – underbreast measurement from 112cm to 127 cm

CardioskinTM electronic kit

  • 1005-10002-EU – Cardioskin Recorder
  • 1005-15004-UN – Cardioskin Battery
  • 1005-15009-UN – Cardioskin Battery Cable
  • 1005-15001-EU – Cardioskin Dock – Dock

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.
The CardioskinTM is a wearable and wireless medical device, which allows acquisition, recording, storage, transmission and displaying of electrocardiogram (ECG).
CardioskinTM is a class IIa medical device. CardioskinTM is a trademark of Biofarma.

 


Wehealth
50 rue Carnot,
92150 Suresnes, France
Please refer to the user manual:
https://manuals.cardioskin.com
BioSerenity SAS
47 boulevard de l’hôpital,
75013 Paris, France