ECG100S
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ECG100S General Information Product name Generic name Product code Cardioline S.p.A. Head Office and Production: Via Linz, 151 38121 Trento Italy The device is a diagnostic electrocardiograph with 12 simultaneous leads which displays, acquires, prints and stores ECG tracings for adults and children. 15 leads are available in print: 12 + Frank leads. Frank’s X,Y,Z deviations are calculated using the inverse Dower transform (IDT) method (which are present when the Glasgow option is active). It also calculates the principal global ECG parameters. The device is equipped with USB (Standard), LAN (optional) and Wi-Fi (optional) connectivity to send exams to the Cardioline ECGWebApp, a system for the centralised management and reporting of ECG exams. The available export formats are SCP-PDF. The device can be supplied with the optional algorithm of the University of Glasgow, equipped with age and gender specific criteria. If this option is enabled, the algorithm provides complete ECG interpretation in short or extended format, including neonatal, paediatric interpretation, and acute myocardial infarction detection with ST elevation. For further information on the resting ECG interpretation algorithm, see the Instruction Manual for doctors for its use with adults and children (see list of accessories). The device can be powered by battery or the mains. It prints out in the following formats: standard or Cabrera 3, 3+1, 3+3 or 6 channels in automatic mode, and 3 or 6 printout channels of the rhythm strip. A smart user interface guides the user through the different steps necessary to acquire the electrocardiogram. Various messages on the screen visually inform the user of the ongoing operations and warn him in case of errors (for example in case of lead fail). ECG100S is a high performance, multi-channel, interpretive electrocardiograph. The ECG signal is acquired by means of a 10-wire patient cable and is displayed in real time on an LCD screen built into the device. The electrocardiograph is able to analyse and store the ECG tracings, send them to an external device via the Internet or via USB, print a 12-lead ECG in automatic or manual mode by means of thermal printer. ECG100S is designed to monitor and diagnose cardiac function. However, a Physician must validate the results of the analysis performed by the ECG. ECG100S is intended for use in hospitals, clinics and outpatient facilities of any size. ▪ The device acquires, analyses, displays and prints out electrocardiograms. ▪ The device interprets the data to be reviewed by a doctor. ▪ The device must be used by a doctor or by specialised staff on behalf of an authorised doctor in clinical facilities. It is not intended as the only means for determining the diagnosis. ▪ The device's interpretation of the ECG analysis is only significant if used together with an additional analysis by the physician of reference and by an assessment of all the patient's important data. ▪ The device can be used on adult and paediatric patients. ▪ The device must not be used as a physiological monitoring of vital signs.

Technical specifications ECG acquisition ECG leads Patient cable Standard 15D connector, 10 wire patient cable Front-end sampling frequency Sampling frequency for signal analysis Dynamic range Pacemaker detection Hardware detection coupled with digital convolution filter AAMI/IEC standard Front-end performance Acquisition mode Automatic (15 leads), Manual (3/6 leads), Stat (15 leads) Lead configuration Standard, Cabrera Processing Operating system Pacemaker detection Hardware recognition compliant with 60601-2-25 requirements Lead-fail detection Independent for all leads. “Torso” function...

Automatic printing program for arrhythmias This program, if activated, automatically printouts (10 seconds) if the electrocardiogram presents ventricular arrhythmias, supraventricular ectopic beats, extreme brachycardia or tachycardia, or atrial fibrillation. Available languages Brazilian Czech, Croatian, Dutch, French, English, Italian, Polish, Portuguese, Romanian, Russian, Serbian, Spanish, German, Turkish, Hungarian, Indonesian. The device performs a self-test of its electronic functions at each switch-on. Processing options Interpretation Glasgow algorithm for adults, paediatric, STEMI...

Printer Technology Paper type Z-Fold 100x150 mm thermal paper Automatic print speed Automatic print 3, 3+1, 3+3, 6 channels; Standard or Cabrera Manual print speed Manual printing 3/6 channels; Standard or Cabrera Printing formats 6x2, 3x4, 3x4+1, 3x4+3; 3x5, 3x5+1, 3x5+3; that includes Frank leads of Glasgow option (only if equipped) Calibration signal Lead identifier Yes, before each trace External USB devices Bar-code reader Magnetic cards reader External storage Electrical features Power supply Medical AC power-supply unit and internal rechargeable battery Power supply unit Medical -...

Environmental storage specifications Temperature 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 (General Data Protection Regulation) Access control An advanced access control mode through a NFC badge is foreseen. With this function the device foresees two operating modes: ▪ ▪ Locked: the device works in anonymous mode, limiting the functions only to the acquisition and sending of ECGs on the net Unlocked: the complete operating mode is enabled through a NFC badge, so the user has...

Classification according to IEC 60601-1-2 – Electromagnetic compatibility Group Performance Standard Other classifications GMDN 110407 - Electrocardiographs, Multichannel, Interpretive Z12050302 - ELECTROCARDIOGRAPHS FOR ADVANCED DIAGNOSIS RDM (Medical Device Catalogue) 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...