Description
Indications for Use
The ELI 250 is indicated for use in a clinical setting, by qualified medical professionals only for recording ECG data of patients.
• The device is indicated for use to acquire, analyze, display and print ECG data for consideration by physicians.
• The device in 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 data by the device are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
• The device is indicated for use on adult populations, typically symptomatic.
• The device is not intended to be used as a vital signs physiological monitor.
System Description
The ELI 250 is a 12-lead diagnostic electrocardiograph capable of viewing, acquiring, printing, and storing ECG data. The ELI 250 is optionally equipped with Mortara’s VERITAS 12-lead resting interpretation algorithm. If this option is enabled, the VERITAS ECG algorithm can provide an over reading physician with a silent second opinion through diagnostic statements output on the ECG report. For additional information on the Mortara VERITAS resting interpretation algorithm, please refer to the Physician’s Guide to ECG Interpretation. Multiple print formats are supported including: 3+1, six, 3+3, twelve, and 6+6 channels in automatic mode and six or twelve channels during rhythm recording. The ELI 250 can operate on battery or line power.
