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The Monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B125/B105 is not intended for use during MRI. The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network. The Monitor B125/B105 monitors and displays : ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement,), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Tympani/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, CO2. The Monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Multifocal PVCs, Missing Beat, Premature Ventricular Contraction (PVC) and Ventricular fibrillation.

The Monitor B125/B105 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K151063) platform. The Monitor B125/B105 provides additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen. As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 is a multiparameter patient monitor, utilizes 12inches /10inches LCD display with an integrated keypad and a pre-configuration (hemodynamic module) which provide basic parameters: ECG, RESP, NIBP, IBP, TEMP, SPO2. As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has optional CO2 parameter provided by the identical E-MiniC module (K052582). As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.