D-Heart Portable ECG Device Technical Description - 13 Pages

Add to MyMedicalExpo favorites
D-Heart Portable ECG Device Technical Description

Catalog excerpts

D-Heart Portable ECG Device Technical Description Rev. 1.1.0 2018-02-14 6

 Open the catalog to page 1

D-Heart Portable ECG Device with lanyard1 Disposable electrodes Charging cable Soft case with embedded Wireless charger Quick Guide 2. GENERAL DESCRIPTION The D-Heart portable ECG (D-Heart ECG) is a 6 electrodes-8 Leads ECG (Fig.1) designed to be worn at the neck that records the electrical activity of the heart and transfers the collected data to a Smartphone via Bluetooth Low Energy (BLE). A dedicated App processes the data received from the ECG and plots an 8-leads electrocardiogram in real time (Fig.2). The App can connect to a dedicated Cloud application for the management of the users...

 Open the catalog to page 2

Fig. 2 D-Heart Portable ECG device ECG recording The useful life of the device is estimated to be 5 years. 3. CLASSIFICATION The D-Heart Portable ECG Device is classified as class IIa medical device according to rule 10 of Annex IX to Directive 93/42 / EEC For the purposes of the CE marking, the EC declaration of conformity for the product quality assurance system (Annex II.3 of Directive 93/42) was carried out relying on the following notified body: Notified Body no. 1370 Bureau Veritas Italia S.p.A. – Via Miramare, 15 - 20126 Milano – Italy. 4. DEVICE OPERATION a. POWER ON/OFF o o When...

 Open the catalog to page 3

5. ENVIRONMENTAL CONDITIONS • Operating Temp (battery discharging): -10°C to 40°C • Operating Temp (battery charging): +5°C to +35°C • Storage Temp: -20°C to +30°C • Storage Humidity: 45% ~ 75% (relative) • Atmospheric pressure range: 700 hPa to 1060 hPa D-Heart Portable ECG Device is compliant with the following standards: • ETSI EN 301 489-1 V2.1.1 (2017-02) issued by Eurotest Lab; • ETSI EN 301 489-17 V2.2.1 (2012-09) issued by Eurotest Lab; • CEI EN 60601-1-2:2016-04 issued by Eurotest Lab; • CEI EN 60601-2-25:2016-04 (1) issued by SIQ; • ETSI EN 300 328: v2.1.1 (2016-11) issued by...

 Open the catalog to page 4

•    The minimum operating time is 24 hours provided that the battery is new and fully charged. •    The battery charge time from depletion to 90 % charge in normal use and battery conditions is 2 hours. • In order to charge the battery the user must place the device on the wireless charger included in the package. Battery charging is made by wireless technology. •    Don't connect the device to the body while the battery is being charged (please note that the device is not operative while the battery is being charged). • The battery charging level must be checked by the user before...

 Open the catalog to page 5

1. Data recording frequency: sampling at 640 Hz with transmission (at 160Hz) of average values every 4 samples; 5. AC Filter: 50/60 Hz digital filter; 6. Muscular Filter: digital filter 25/40 Hz; 7. Tracings recorded on calibrated paper. Acquisition modality can be AUTOMATIC if D-Heart App is in the setting 'individual', MANUAL if D-Heart App is in the setting 'health professionist'. Standard Acquisition velocity is 25 mm/s. However, in D-Heart App settings acquisition velocity can be changed to 50 mm/s. Final ECG tracing would show DI, DII, DIII, aVR, aVL, aVF, V2, V5. ECG recording can...

 Open the catalog to page 6

The authentication controllers group is the first one that user access when the application has been launched. After a 3 seconds splash screen, D-Heart opens an infographic that explain what D-Heart is and how to use It, with a checkbox to avoid to show this controller in future. After the infographic, D-Heart opens the main controller of the authentication group. From this controller, user can authenticate, enable Touch ID login or create new account (after the acknowledge of Terms and Conditions). After the authentication, if the account is not yet completed the application will prompt...

 Open the catalog to page 7

The settings controller has buttons to navigate to specific application settings, device settings, last accepted Terms and Conditions and a link to the Feedback and Help system. If the user hasn’t a D-Heart device connected, there will be a button to order it. On the top part of the controller there are the number of reports available (already paid by the user) and the number of electrodes that user might have, based on the number of electrodes ordered and on the number of exams already done. Both of these counters have the button to buy other reports and electrodes, plus the QR code icon...

 Open the catalog to page 8

On the navigation bar there will be the calendar button and the Patient filter button. With the calendar button, a calendar will be shown in the controller, and user can select a date to see exam done in the selected day. If user select the patient filter button, a search bar with the last patient shortcut will be shown and exam can be filtered by patient’s name. If user select an ECG, the ECG Result controller will be shown. The profile flow starts with the list of all patients found on the device with a search bar. If the user searches for a cloud patient or a cloud exam, the patient will...

 Open the catalog to page 9

During the registration user can see the ECGs on the screen. There will be a countdown that shows the remaining registration time and the real time heart rate (BPM). Should any error occur with the communications (e.g. Packet loss with the Bluetooth device) the registration restarts (the count down as well). If the sensor disconnect during the exam, the complete ECG flow will be restarted from the real time help for the electrodes. The minimum set of ECG data that the application needs to complete the exam is 12 seconds (to fill a landscape A4 ECG report). If the registration is completed...

 Open the catalog to page 10

D-Heart is a medical device that is regulated by international laws; we rigorously test and validate devices with smartphones and tablets to meet or exceed these regulations before we claim compatibility. We routinely add support for new phones and tablets. Check back if your device is not listed below. (Last updated on March 6th, 2018) Apple Compatibility iPhone X (iOS 11.1) iPhone 8 Plus (iOS 11.1) iPhone 8 (iOS 11.1) iPhone 7 Plus (iOS 11.1) iPhone 7 (iOS 10.0.2) iPhone 6s Plus (iOS 11.1) iPhone 6s (iOS 11.1) iPhone 6 Plus (iOS 11.1) iPhone 6 (iOS 11.1) iPhone SE (iOS 11.1) iPhone 5s...

 Open the catalog to page 11

All D-Heart catalogs and technical brochures