ECG200L
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PRODUCT SHEET: ECG200L Description of product: The device is a 12-lead, fully diagnostic electrocardiograph which displays, acquires, prints and stores ECG tracings, for adults and children, together with its measurements.. ECG200L is characterized by a useful 7” colour touchscreen display, from which all operations can be easily performed. 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). The device is equipped with USB to export the ECG stored in the device memory. The device can be supplied with the optional 12-lead Glasgow resting ECG interpretation algorithm, with specific criteria by age, sex and race. 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, 6 or 12 channels in automatic mode and 3, 6 or 12 printout channels in continuous mode, as well as printout of the rhythm strip. It is possible to export the exams on a key or USB to a PC software application named ECGEasyApp. GENERAL INFORMATION Product Name General Name Product Code Cardioline S.p.A. Headquarters Via Linz, 151 38121 Trento Italia ECG200L is a multi-channel, interpretative resting electrocardiograph. The ECG signal is acquired with a 10-wires patient cable and is displayed in real time on a LCD screen integrated in the device. The electrocardiograph can analyse and store the ECG traces, send them to an external peripheral via USB, print the 12 lead ECG in automatic or manual mode by means of its built-in thermal printer. ECG200L is intended for assessment and diagnosis of cardiac functions. In any case the results of analysis performed by the electrocardiograph must be validated by a Physician.

ECG200L 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 intended to provide the physician with an automatic interpretation of the ECG to be reviewed 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...

Lead fail detection Independent on all leads. “Torso” function that allows you to view the disconnected electrodes in red and those correctly connected in green. Heart Rate Meter Linear phase digital diagnostic high-pass filter (according to 60601-2-25 2nd ed.) 50/60 Hz AC interference adaptive digital filter Digital low pass filters at 25/40 Hz, for display and printing only All leads, average, corrected HR Average RR PR Interval QRS duration QT interval and QTc interval, with Hodges, Bazzet and Fridericia’s formula max R[V5]or[V6] and S[V1] Sokolow-Lyon Index P, R, T axis. Glasgow...

Auto print speed Auto print 3, 3+1, 6, 12 channels; Standard or Cabrera Manual print speed Manual Print 3/6/12 channels; Standard o Cabrera Rhythm Print 1 minute 3 leads; 3 minutes 1 lead HR Trend HR statistics Printing formats Calibration signal Lead marker Yes, before each lead trace USB External Peripherals External data storage USB memory stick (for data export) Electrical Characteristics Power source Internal power supply and internal rechargeable battery Input Voltage Input Current Input frequency Rated Output Protection Class Battery Type Battery Duration more than 500 ECGs – more...

REGULATORY AND SAFETY Classification according MDD 93/42/CEE Class rule 10 annex IX 93/42/EEC Directive and its amendments Notified body Classification according to FDA regulation Classification: Product Code: Review Panel: Regulation Number: Classification according to IEC 60601-1 - Electrical Safety Protection against electric shock: Internal power - class I Applied parts: Protection against harmful ingress of water or particular matter: Suitability for use in an oxygen rich environment: continuous operation Classification according to IEC 60601-1-2 - Electro Magnetic Compatibility Group...

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 and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests Medical device software - Software life-cycle processes Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability...