
Electrocardiograph
- Description
Description
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
Accessories: 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)