Multiparameter monitor - India CDSCO Medical Device Registration

Product Information

The Grand Canal patient monitor products are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Grand Canal patient monitor products are intended for use under the direct supervision of a licensed health care practitioner. The Grand Canal patient monitor products are not intended for use during MRI. The Grand Canal patient monitor products can be stand-alone monitors or interfaced to other devices via network. The Grand Canal patient monitor products monitor and display: ECG (Patient Monitor B125P/B105P/B125M/B105M/B155M), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (Patient Monitor B125P/B105P/B125M/B105M/B155M), functional oxygen saturation (Patient Monitor B125P/B105P/B125M/B105M/B155M) and pulse rate via continuous monitoring(Patient Monitor B125P/B105P/B125M/B105M/B155M), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Nasopharyngeal/ Tympanic /Rectal /Bladder /Axillary /Skin /Airway /Room /Myocardial /Core/Surface temperature, impedance respiration, respiration rate, airway gases (Patient Monitor B125P/B105P/B125M/B105M/B155M), Cardiac Output (Patient Monitor B125P/B105P/B125M/B105M/B155M), Entropy and neuromuscular transmission (Patient Monitor B125P/B105P/B125M/B105M/B155M). The Grand Canal patient monitor products are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, “R on T”, Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (Patient Monitor B125P/B105P/B125M/B105M/B155M), Supra Ventricular Contraction (Patient Monitor B125P/B105P/B125M/B105M/B155M) and Ventricular fibrillation. (Patient Monitor B125P/B105P/B125M/B105M/B155M)