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iBSM is a wireless monitoring system intended for the display of electrocardiography (ECG) waveform, heart rate measurements, respiratory rate measurement and waveform, functional oxygen saturation of arterial hemoglobin (SpO2), activity, body position, fall detection, skin temperature and Blood Pressure parameter measurements by qualified healthcare professionals in healthcare settings. iBSM continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not changed from a preset time threshold. The iBSM device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The iBSM device is not intended for use on critical care patients. The iBSM BP cuff is not intended for subjects that are considered special populations. The iBSM device is indicated for monitoring ECG waveforms and heart rate on non-ambulatory patients. The iBSM device is intended to be used in wards and patient rooms in professional healthcare facility environment hospital settings. The iBSM device is not intended to be used in Home environment or special environment. The iBSM device is not intended to be used in an ambulatory environment for noninvasive blood pressure, respiratory rate and SpO2 measurement parameters. The iBSM device is not intended to monitor or measure respiratory rate, SpO2, or noninvasive blood pressure while the patient undergoes significant motion or is active. The iBSM device is not intended to be used in the ICU/CCU or Surgery/OT rooms iBSM is compatible with third-party, FDA cleared devices such as ANNE Chest from Sibel Health Inc, for ECG, HR, RR, body position and skin temperature measurements; and ANNE Limb from Sibel Health Inc. for SpO2 and skin temperature measurements. iBSM is compatible with third-party, FDA-cleared BP devices such as BP2A from Shenzhen Viatom, for non-invasive blood pressure measurements. The iBSM device communicates with an external server for patient data communication and storage. The iBSM device includes the ability to notify healthcare professionals when physiological data fall outside selected parameters with the use of audio and visual alarms. The iBSM chest sensor is not intended to be used to provide diagnostic or or interpretive statements to either the patient or the clinician. The iBSM chest sensor is NOT intended to be used on critical care patients and is not a remote diagnostic device. The iBSM chest sensor is NOT intended for use on patients with implanted pacemakers. The iBSM Chest sensor is NOT intended for use on patients with known allergies, or hypersensitivities to, adhesives or nickel. The iBSM Chest Sensor is NOT intended for patients with significant cardiorespiratory disease including patients that are oxygen dependent. The iBSM Chest Sensor is NOT intended for patients with significant respiratory muscle weakness due to an underlying neuromuscular condition (e.g., myasthenia gravis, amyotrophic lateral sclerosis, or muscular dystrophies) The data and results provided by the BP cuff device are for precheck screening purposes only and cannot be directly used for diagnosis or treatments.

The iBSM device is a wireless vital sign and physiological data monitoring device that streams real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate(HR), respiratory rate(RR), body position, SpO2 and skin temperature. The waveforms of ECG, Respiration and PPG are also displayed. The ECG signal is not intended for automated arrhythmia detection or classification. Rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tomkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two third party FDA cleared skin-mounted, bio-integrated sensors that pair with the iBSM View application for the continuous display and storage of vital sign measurements and physiological waveforms. The two sensors viz. iBSM chest (Anne Chest from Sibel Health Inc) and iBSM limb (Anne Limb from Sibel Health Inc) sensors are used along with their respective biocompatible iBSM chest sensor adhesive and iBSM limb sensor adhesives and attached to the patient. The adhesives are intended for a single use, whereas the sensors are intended for multiple reuse with the predefined processing. Both the chest and the limb sensors along with their adhesives are third party FDA cleared devices. The system is also compatible with a third-party FDA cleared non-invasive blood pressure measurement device (Blood Pressure monitor BP2A from Shenzhen Viatom Technologies). The iBSM device consists of a mains powered Docking station that provides the mechanical base station for the iBSM Tablet and has a provision to charge the tablet when docked. The USB connector provided on the Docking station is intended only to power up the sensor charger accessory and any data transfer to the USB device is disabled. The iBSM View Application runs on the iBSM tablet in a secure Kiosk mode and is intended to display the patient's physiological parameters and waveforms. The iBSM tablet with the iBSM View Application together is termed as iBSM hub. The physiological data obtained by the sensors are wirelessly transmitted to their respective SDK's that are part of the iBSM hub with Bluetooth (BLE) connectivity, for continuous display of waveforms and parameters on the iBSM View Application. When connected to WiFi, vital signs data can be transferred in real-time from the iBSM hub to an external Server for data storage. The iBSM system provides an FHIR-compatible interface for patient data communication and storage to an external Server. iBSM is intended to be used only in an hospital environment within the wards or patient rooms and not in ICU/CCU nor in Surgery/OT rooms. It is intended to be used for monitoring of non critical patients. iBSM is not intended to be used in a home environment. iBSM uses the third party FDA cleared sensors such as ANNE Chest and ANNE Limb from Sibel Health Inc. and BP2A BP Cuff from Shenzhen Viatom, that fulfill the requirements of performance parameters in the signal acquisition before transmitting the data to their SDK's integrated with the iBSM Application in the iBSM hub for displaying the waveforms and the parameters.