Intended Use

The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population. In the United States and Australia, the intended use is for patients over 18 years old only. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment of the heart rhythm. The Cardiologs Holter Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.

The Cardiologs Holter Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. The Cardiologs Holter Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.

The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.

The Cardiologs Holter Platform is a Medical Device Class IIa in Europe (CE 2797) in compliance with the Medical Device Regulation (EU MDR 2017 / 745) / Class II in the USA according to the 510(k) clearance. 

Warnings:

Access to the ECG analysis is reserved for Healthcare Professionals who are legally allowed to use a Class IIA medical device in Europe or Class II in the USA. Access to people not pertaining to this category is expressly prohibited. Cardiologs Holter Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Carefully read the Instructions For Use prior to use. Any personal identification displayed in Cardiologs Holter promotional documents has been made up.

Legal mentions:

The content of this document, in particular data, information, trademarks and logos are Philips sole property. Consequently, all representation and/ or reproduction, whether in part or in full, is forbidden and would be considered a violation of Philips and affiliates’ copyrights and other intellectual proprietary rights. This document with associated pictures is non-contractual and is solely dedicated to healthcare professionals. The product shall exclusively be used in accordance with the instructions for use.