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ECG100+
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Catalog excerpts

ECG100+ - 1

ECG100+ General Information Product Name General Name Product Code Cardioline S.p.A. Registered Office and Factory: Via Linz, 151 38121 Trento Italy Device Description The device is a diagnostic electrocardiograph with 15 simultaneous leads (12 + Frank) which displays, acquires, prints and stores ECG tracings for adults and children. The Frank X, Y, Z leads are calculated by the Glasgow algorithm, so they are present when the Glasgow option is enabled. It also calculates the main overall ECG parameters. The device is equipped with full connectivity: USB(standard), LAN (standard) and WiFi (optional). Different export formats and protocols are available: SCP-PDF (standard), XMLGDT (included into the standard connectivity option), DICOM (included into the DICOM connectivity option) and HL7 (optional) to interface with all standard management systems. 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 full ECG interpretation in short or extended form, including infant, pediatric and acute ST elevation myocardial infarction detection. For further information on the resting ECG interpretation algorithm, see the Guidance for the physician on the application on adults and children (see accessories list). The device is battery or mains operated. The printing formats supported include: standard or Cabrera 3, 3+1, 3+3 or 6 channels in automatic mode and 3 or 6 channels rhythm strip printing. 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). ECG100+ is a high-performance, multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on an LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via Internet or via USB, print the 12 lead ECG in automatic or manual mode by means of a thermal printer. ECG100+ is intended for control and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Cardiologist. ECG100+ is intended for use in hospitals, in medical clinics and doctor’s offices of any size.  The device is indicated for use to acquire, analyse, display and print electrocardiograms.  The device is indicated for use to provide interpretation of the data for consideration by a physician.  The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.  The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.  The device is indicated for use on adult and paediatric populations.

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ECG100+ - 2

The device is not intended to be used as a vital signs physiological monitor. Technical Specifications ECG Acquisition ECG leads Patient Cable Standard 15D connector, 10 wires patient cable Input impedance Sampling rate of the input stage Sampling rate for signal analysis Output Data Resolution Dynamic Range Pacemaker detection Hardware detection coupled with convolution digital filtering Defibrillation Protection AAMI/IEC standards Front-end performance Acquisition Mode Automatic (15 leads), Manual (3/6 leads), Stat (15 leads) Lead Configuration Standard, Cabrera Processing Operating...

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ECG100+ - 3

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. Internal storage up to 100 ECGs Available languages Brazilian Czech, Croatian, Dutch, French, English, Italian, Polish, Portuguese, Romanian, Russian, Serbian, Spanish, German, Turkish, Hungarian The device performs an auto-test of its internal electronic functions at every start up. Processing Options Interpretation Glasgow Analysis...

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ECG100+ - 4

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 marker Yes, before each lead trace USB External Peripherals Barcode reader Magnetic Card Reader External data storage Electrical Characteristics Power source Medical grade power supply and internal rechargeable battery Power supply Medical grade - Mod. AFM60US18 - XP Power Limited Input Voltage power supply Input Current power supply Input frequency power supply Rated Output power supply Protection Class power supply Degree of Protection power...

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ECG100+ - 5

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 access to the parts containing sensitive data too. After a period of inactivity or at the operator's command, the system returns to the locked state. Data at rest protection The...

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ECG100+ - 6

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 (ISO 13485:2003) Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Medical electrical equipment - Part 1-2: General requirements for basic safety...

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