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Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register. analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width. It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program. For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment. - The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements. - Intended use is equivalent to the intended use of the predicate Cardioline AR . 1200 and CorScreen electrocardiograph.

The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0. The device includes protection against defibrillation integrated. Provides the automatic interpretation based on the program Hannover Ecg System HES® developed by Biosigna GmbH under the standards IEC 60601-2-51:2003. Uses the format SCP (Standard Communications Protocol) to import and export the ECG records in the framework of the CSE (Common Standards for Quantitative Electrocardiography) of the European Union. The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.