touchECG System Config. Package Android HD+
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touchECG General Information Product name Generic name touchECG - Android Product code Cardioline Spa Head Office and Production: Via Linz, 151 38121 Trento Italy Device Description touchECG is a software application that implements a 12-lead electrocardiograph based on multi-platform PC (laptop, tablet, smartphone). The ECG signal is acquired by the acquisition unit of the HD+ series (HD+, HD+ 12), which transmits it via Bluetooth to the computer on which touchECG is installed, which, in turn, acquires, displays, prints and archives the ECG tracings for both adults and children. touchECG is compatible with the first version of the Cardioline HD+ device or with the most recent version of Cardioline HD+ 12, which support 12-lead formats. touchECG includes the Glasgow interpretation algorithm, with specific age, sex and ethnic group criteria, which makes it possible to analyse, measure, and, optionally, automatically interpret the ECG, providing the main overall parameters for an evaluation by the doctor. If the Glasgow option is enabled, the algorithm can provide the doctor with an automatic interpretation with diagnostic messages on the ECG report. touchECG has various display and print formats and various filters that can be applied to the ECG tracings. In addition, touchECG is equipped with calipers to perform signal measurements. touchECG can be configured with three options:  interpretation of the ECG through the Glasgow algorithm  DICOM function  local database with revision and serial comparison functions. TouchECG also features pacemaker detection, which displays detected pacemaker pulses on the ECG trace, and arrhythmia detection during real-time acquisition. Additionally, the lead-reverse function detects any reversed electrodes during connection to the patient and alerts the user via a message on the display. The doctor can report directly through the software, analysing the tracings and filling out the related fields, and printing the test. The software is compatible with the Android operating systems and can be installed on any tablet, notebook or smartphone that meets the minimum requirements indicated. touchECG is intended to monitor and diagnose cardiac functions. However, a cardiologist must validate the results of the analysis run by the ECG. touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is also suitable for use at home and in an emergency setting (ambulance) by medical personnel or specialized personnel acting on behalf of an authorized doctor. In addition, touchECG is suitable for use in telemedicine at outpatient facilities, pharmacies or other similar contexts. touchECG is intended for use exclusively with the Cardioline HD+ devices (HD+, HD+ 12). The Cardioline HD+ devices acquire the ECG signal and send it, via Bluetooth, to the device on which the touchECG software is installed.

The analysis of the ECG tracings and the automatic interpretation carried out by touchECG must always be validated by a doctor. The device does not provide a diagnosis but only provides an interpretation of the data based on the Glasgow interpretation algorithm.  The device is intended to acquire, analyze, display and print out electrocardiograms. The device is intended to interpret the data to be then reviewed by a doctor. The device is intended to be used by a doctor or by specialized personnel on behalf of an authorized doctor in clinical facilities. It is not intended as the only means...

Pacemaker detection 128,000 samples/second/channel software recognition, Pulse duration range: 0.2 ms - 2 ms, Pulse width range: 2mV – 250mV. Exceeds the IEC 60601-2-25:2011 performance Defibrillation protection AAMI/IEC standard Front-end performance Data transfer Bluetooth 2.1+ EDR with “secure pairing” for HD+ 500Hz Bluetooth Low Energy 4.2 for HD+ 12 500Hz Processing Operating system Pacemaker detection Software recognition (HD+ device) Lead-fail detection Reversed electrodes detection Reversed electrodes detection when connecting the patient. Heart rate range Sampling rate Linear phase...

Geräte Daten Transfer Connectivity USB-LAN-WiFi Available depending on the computer chosen Printing Paper size Automatic print speed Automatic print formats Manual print speed Manual print formats Calibration signal Lead marker With/without grid, colour, black and white Complete printing (solid line every 5 mm and dashed line every 1 mm), Semi-complete (solid line every 5 mm), Blank (without lines) External USB devices Bar-code reader Regulations and Safety Classification according to MDD 93/42/EEC Class Rule 10 annex IX Directive 93/42/EEC and its amendments Notified Body GDPR Compliance...

Performances (ECG display) Standard Other classifications GMDN Z12050302 - ELECTROCARDIOGRAPHS FOR ADVANCED DIAGNOSIS RDM (Medical Device Catalog) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Information supplied by the manufacturer of medical devices Medical devices - Quality management systems - Requirements for regulatory purposes Medical devices - Application of risk management to medical devices Medical devices - Symbols to be used with medical device labels, labelling and information to be...