Product description:

A mains electricity (AC-powered 220 V) bedside device designed to continuously detect, measure, and display a patient’s electrocardiogram (ECG) through leads attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient’s parameters drop below or exceed pre-set limits.


Technical characteristics:

·        Automatic equipment calibration.

·        12 electrographic standards lead measuring with simultaneous acquisition.

·        Visualization of at least one group of 3 leads simultaneously.

·        LCD or TFT color monitor display of at least 7 inches with visualization of analogical curves, alphanumeric values measured and the related physiological limits.

·        Bandwidth in monitor mode not smaller than 0.5 to 100 Hz and sampling rate not less than 1 KHz.

·        Equipment compatible with patients with pacemakers.

·        Protection against defibrillation.

·        Automatic internal data storing up to at least 40 ECG records.

·        Input impedance not less than 5MΩ.

·        Patient leakage current no higher than 10uA.

·        ECG signal measurement range not smaller than -2 mV to +2 mV.

·        At least the following adjustable alarms:

Ø  heart failure;

Ø  ventricular fibrillation;

Ø  tachycardia;

Ø  bradycardia;

Ø  Electrode disconnection.

·        Equipment provided with filters at least for baseline instability, AC 50/60Hz interference, rumours, etc.

·        Equipment provided with at least the following software applications:

Ø  arrhythmias detection and analysis;

Ø  ventricular fibrillation detection and analysis;

Ø  ventricular tachycardia detection and analysis;

Ø  ST segment analysis.

·        Integrated printer using standard A4 format paper.

·        Selectable printing paper speed at least of 5, 25 and 50 mm/sec.

·        Built in battery minimum one hour


Clinical purpose: Continuously detect, measure, and display a patient’s electrocardiogram (ECG) through leads and sensors attached to the patient

Level of use: Health center, district hospital, provincial hospital, specialized hospital

Clinical Departments/Ward: Hospitalization



10 lead ECG cable

Six suction ball-type reusable chest electrodes;

Four extremity clamp reusable electrodes;

Class Certification: Class B (GHTF Rule 10); Class II (USA); Class II (EU, Japan, Canada and Australia)

Regulatory approvals: FDA or CE approved product.

International Standard: ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes (Australia, Canada and EU)