The requested ID page is also available in the following languages: Polish

Certified Management Systems

EN ISO 13485 and MDD Annex II excl. 4

Certificate Holder: Telemedical Innovations Sp. z o.o.

Test Mark Number: 9000013739

The certificate holder's Management System corresponds to standard EN ISO 13485:2016.

Logo firmy telemedical innovations
Certificate scopes:
  • EN ISO 13485:

    Design and development, manufacture and distribution of ECG signal recorders with dedicated software and equipment.

  • MDD Annex II excl. 4:

    - CARDIOVICE ECG Recorder
    - CARDIOVICE App

Description:

Telemedical Innovations Sp. z o.o. based in Gliwice was established in December 2016. In the beginning, the team set itself the goal of creating a professional ECG vest that would allow the patient to perform 12-lead ECG tests. During research and development, the project was expanded. The entire CARDIOVICE ™ telemedicine system was created, consisting of an ECG recorder, its equipment, mobile software (iOS, Android), and a cloud platform. The CARDIOVICE ™ system enables remote monitoring of the patient's health from anywhere in the world using a smartphone or tablet. A patient can perform a 12-lead ECG test (the gold standard of diagnostics) using an innovative vest. Currently, the Company has a fully operational system and devices. The ISO 13485 system was implemented and laboratory tests and audits were completed, confirmed by TÜV Rheinland certificates. The company's products are medical devices and have a CE declaration of conformity. The company has already started work on the expansion of the CARDIOVICE ™ system, which will enable, i. a., independent measurement of the level of fluid in the lungs using bioimpedance - the most effective of the so far known assessments of heart efficiency (the Company has a PATENT in the territory of the Republic of Poland and the EU). In addition, the new system will be enriched with automatic diagnosis and the prediction of cardiological incidents, and the measurement of temperature and humidity of the skin. The system will integrate a blood pressure monitor, scale, glucometer, and pulse oximeter. The mobile application and the cloud platform will be expanded, thanks to which they will create a comprehensive solution for healthcare entities.

 

Telemedical Innovations – CARDIOVICE™ devices description

CARDIOVICE ECG Recorder
The CARDIOVICE ECG Recorder is an electronic medical device that enables the acquisition of high-quality ECG records. The device is operated using the free CARDIOVICE App installed on mobile devices. Tests are performed with the use of various dedicated CARDIOVICE ™ accessories connected by the D-Sub 15 pin socket on the ECG recorder. Depending on the equipment, the recorder allows you to record an ECG test in the number of 6 to 12 leads. The device is intended both for individual users, home use, and medical personnel for professional use. The CARDIOVICE ECG Recorder is a class IIa medical device.

CARDIOVICE ECG App CARDIOVICE App mobile application is installed on mobile devices with Android or iOS systems (e.g. smartphone, tablet) and is used to control the ECG recorder, process the acquired ECG signal, and manage the user account and test archive. The main functions of the CARDIOVICE App mobile application include:

• user account management (individual user / medical staff),
• support for connecting wirelessly via Wi-Fi with the ECG recorder,
• selection of the currently used ECG recorder accessory,
• tips for using the accessory,
• control of the correct contact of the ECG electrodes with the user's skin,
• recording of a 35-second ECG examination, • creating a survey for the performed ECG test,
• graphical presentation of ECG curves of the performed examination on the screen of a mobile device with the possibility of scrolling and enlarging the examination record,
• generating a report with ECG curves of the performed examination in PDF format,
• access to the archive of performed ECG tests,
• possibility of sharing ECG test reports and questionnaires in PDF format, using tools available on the mobile device (e.g. sending by e-mail, printing).

The mobile application is intended both for individual users, home use, and medical personnel for professional use. The CARDIOVICE App is a class IIa medical device. The data of the CARDIOVICE App mobile application is automatically synchronized in the cloud on secure servers (via the Internet). The user may also log into his account via the CARDIOVICE Cloud Platform interface, using a web browser at the following address: https://www.cardiovice.com/cloud. After logging in, the user has access to all his data and ECG tests performed in PDF format.

CARDIOVICE ECG Vest The ECG vest CARDIOVICE ECG Vest has built-in electrodes and is designed to obtain an ECG recording using a dedicated ECG recorder CARDIOVICE ECG Recorder. After connecting the ECG vest with the ECG recorder, it is possible to obtain 12 ECG leads in the Mason and Likar system (6 limb leads: I, II, III, aVR, aVL, aVF, and 6 precordial leads: V1 - V6). CARDIOVICE ECG Vest is equipped with protection against defibrillation. The ECG vest is made of two layers of modern softshell fabric. In the bottom layer, there are 10 metal ECG electrodes made of SUS 316L stainless steel. The top layer has a system of adjustable rubbers that allow the vest to fit the body and ensure proper contact of the electrodes with the skin. Between the layers, there is an ECG cable, the role of which is to connect the ECG electrodes with the ECG recorder. The ECG vest comes in different sizes. CARDIOVICE ECG Vest is intended both for individual users, home use, and medical personnel for professional use. CARDIOVICE ECG Vest is a I class medical device.

CARDIOVICE ECG Module The module with built-in ECG electrodes CARDIOVICE ECG Module is designed to obtain an ECG recording using a dedicated ECG recorder CARDIOVICE ECG Recorder. After connecting the ECG module with the ECG recorder, it is possible to obtain 6 ECG leads (6 limb leads: I, II, III, aVR, aVL, aVF). CARDIOVICE ECG Module is equipped with protection against defibrillation. The module has 4 built-in ECG electrodes made of SUS 316L stainless steel and a D-sub 15 pin socket through which it connects to the recorder. The test is performed by placing the module against the chest. The CARDIOVICE ECG Module is intended both for individual users, home use, and medical personnel for professional use. The CARDIOVICE ECG Module is a I class medical device.

CARDIOVICE 5-wire ECG Cable ECG 5-wire cable CARDIOVICE 5-wire ECG Cable is designed to obtain an ECG recording using a dedicated ECG recorder CARDIOVICE ECG Recorder. After connecting the ECG cable with the ECG recorder, it is possible to obtain 7 ECG leads (6 limb leads: I, II, III, aVR, aVL, aVF, and 1 precordial lead: C). CARDIOVICE ECG 5- wire Cable is equipped with protection against defibrillation. The cable has snap-type tips for connecting disposable self-adhesive electrodes and a D-sub 15 pin plug through which it connects to the recorder. The test is performed by applying, to the chest, disposable self-adhesive electrodes previously attached to the cable. CARDIOVICE ECG 5-wire Cable is intended both for individual users, home use, and medical personnel for professional use. CARDIOVICE ECG 5-wire Cable is a I class medical device.

CARDIOVICE 10-wire ECG Cable PRO 10-wire ECG cable CARDIOVICE 10-wire ECG Cable PRO is designed for obtaining an ECG recording using a dedicated ECG recorder CARDIOVICE ECG Recorder. After connecting the ECG cable with the ECG recorder, it is possible to obtain 12 ECG leads (6 limb leads: I, II, III, aVR, aVL, aVF, and 6 precordial leads: V1 - V6). CARDIOVICE ECG 10-wire Cable PRO is equipped with protection against the shock pulse. The cable has banana-type tips for connecting suction and clamp electrodes and a D-sub 15 pin plug, through which it connects to the recorder. The test is performed using the suction cup and clamp electrodes, which should be connected to the cable and then positioned on the chest and limbs, respectively. It is also possible to use self-adhesive electrodes after using a special BANANA/SNAP adapter. CARDIOVICE ECG 10-wire Cable PRO is intended both for individual users, home use, and medical personnel for professional use. The CARDIOVICE ECG 10-wire Cable PRO is a I class medical device.
 

 

 

 

Further information by the certificate holder: The certificate holder has not provided further information.
Contact to the certificate holder: Telemedical Innovations Sp. z o.o.

Ul. Wincentego Pola 27
44-100 Gliwice
Poland