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.
· 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 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)