Instructions for Use
GE Health Innovation Village, 2 Kuortaneenkatu, Helsinki, 00510.
The Cardiolyse is intended to record, store, analyze, display and transfer up to twelve (12) leads electrocardiogram (ECG).
The Cardiolyse software performs QRS, Ventricular Ectopic Beats, Supraventricular ectopic beats detection, QRS feature extraction, interval measurement, heart rate measurement, rhythm analysis and abnormal ST-T changes for up to 12 leads ECG.
Cardiolyse software also performs automatic ECG interpretation of common abnormalities, including ventricular hypertrophy and myocardial infarction for 12 leads ECG.
The Cardiolyse interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians on an advisory basis only in conjunction with the physician’s knowledge of ECG.
The device has not been tested and it is not intended for pediatric use.
Indicates the medical device manufacturer, as defined in EU Directives 93/42/EEC
Date of manufacture
Indicates the date when the medical device was manufactured.
Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
Consult instructions for use
Indicates the need for the user to consult the instructions for use.
SAFETY AND PERFORMANCE
Cardiolyse.me software as a medical device safety and performance was validated based on device’s equivalence and clinical evaluation data.
ECG algorithms were validated on widely acceptable databases MIT-BIH, NST, CU, ESC as well as CSE.
Algorithm’s sensitivity and specificity is highly dependent on signal quality provided by device.
LIST OF FEATURES THAT HAS NOT BEEN VALIDATED AS A MEDICAL DEVICE:
1. To install Cardiolyse.me mobile app you need Android version 6+.
Go to Google Play Market and search for “Cardiolyse.me”.
2. After installing you need to create an account with intuitive instructions. Just click on “Sign UP” and follow the steps described there.
1. To use Cardiolyse.me you need to pair ECG device which support Bluetooth BLE protocol and has at least 200 Hz sample rate.
In doctor’s account:
Select or create new patient and click on the record button (bottomright)
In patient’s account:
Click on the record button (bottomright)
2. Select type of device that you have:
Live Signals - device from Live Signals company
NeuroSky - device from NeuroSky company
Solvaig - device from Solvaig company
Faros - device from Bittium company
Beurer - device from Beurer company
HRV device - all other devices that support Bluetooth BLE protocol
3. Then select device from the list of devices around you (Don’t forget to turn Bluetooth ON!)
4. You will see that app is trying to pair.
5. When device connected you will see “CONNECTED” in top panel of app. Also you will see “START” button which indicates that app is ready for recording.
The following example uses Solvaig ECG (only as an example). Read your device’s instruction to properly record ECG.
1. Place your fingers on pads
2. Click on “START” button in Cardiolyse.me app (you will see ECG wave in real time)
3. When record will be analyzed and the results will be received you will see details of record.
To get access of Cardiolyse.me product you need to open in your browser https://dashboard.cardiolyse.com/
Website was tested on all following browsers starting on version:
Internet Explorer: IE 11 and later
EDGE: 16 and later
Firefox: 52 and later
Chrome: 57 and later
Safari: 10.1 and later
Opera: 44 and later
SIGNING IN / SIGN UP
To create an account or login use form that is presented to you as a main page.
LIST OF PATIENTS
List of patients available as a panel on the left hand side after logging in
SEEING THE RECORD
To see the record click on it from the list after selecting patient. Each patient has a list of records.
SEEING DETAILED REPORT
On the right side there are 3 icons: Detailed report, download report, download record.
To see detailed report click on the top icon
The ECG app cannot check for signs of a heart attack. If you believe you’re having a medical emergency, call the emergency services.
DO NOT take recordings when in close vicinity to strong electromagnetic fields (e.g. electromagnetic anti-theft systems, metal detectors).
DO NOT take recordings during a medical procedure (e.g., magnetic resonance imaging, diathermy, lithotripsy, cautery and external defibrillation procedures).
DO NOT take a recording during physical activity.
DO NOT use ECG formats other than EDF / EDF+
Read instructions before use
Issue 1 of 15.05.2019