Product Manual

SECTION 1

The device includes:

• Acquisition module with lead wire set

• Hospital-grade power cord

• Antenna (with WLAN or GPRS mobile)

• 1 pack paper

• 1 package of electrodes

• Physicians Guide Adult & Pediatric (with interpretation feature)

• User manual CD

• Accessory starter kit

Intended Use (Functional Purpose)

The ELI 150c or ELI 250c is intended to be a high-performance, 12-lead, multifunctional electrocardiograph. As a

resting electrocardiograph, ELI 250c simultaneously acquires data from 12 leads. Once the data is acquired, it can

be reviewed and/or stored, and/or printed. It will be a device primarily intended for use in hospitals but may be

used in medical clinics and offices of any size.

Indications for Use

• The device is indicated for use to acquire, analyze, 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 pediatric populations.

• The device is not intended to be used as a vital signs physiological monitor.