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Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. Central Station does not perform any data processing on the data received from the Nihon Kohden compatible devices. When Central Station is connected with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the Central Station can: • Admit and discharge patients on the Nihon Kohden network. • Display and manage compatible devices' real-time patient clinical data, vital signs, alarms and waveforms. • Review and trend data calculated by connected Nihon Kohden devices. • Store and transfer historical clinical data for the connected systems. • Print patient data. Central Station is intended for use in professional medical facilities by trained medical personnel.

Central Station is software only product that is installed on a Commercial Off the Shelf (COTS) Computer. Central Station displays waveforms data and numerical data from a connected bedside monitor, vital sign telemeter, or multiple patient receiver unit on the screen. Central Station is a network device, intended to provide remote patient monitoring to medical personnel. Central Station displays a list of measured values and a trend graph. Numerical data and various waveforms are color-coded for each parameter. Central Station also has the function of displaying an alarm. Alarm indication in Central Station is displayed as a result of a judgment by the bedside monitor, vital sign telemeter, or multiple patient receiver units connected to the Central Station. Central Station itself does not have the function to perform alarm indication judgment.

The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters. The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds. When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.

hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals. hinscope is intended for spot-check measurements, in adults, of: - Non-Invasive blood pressure (NIBP) - - -Pulse rate (PR) - -Oxygen saturation (SpO2) hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms. hinscope is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). hinscope is not a substitute for an ECG monitor. hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

hinscope consists of the: - hinscope measurement unit - hinscope mobile application hinscope consists of a vital sign measurement unit, that is positioned on the patient's upper arm, and a mobile application with a user interface which allows display of the vital sign data. hinscope is a combination of optical sensors and a sphygmomanometer cuff which provide measurements of the patient's pulse rate (PR) oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). PR and SpO2 are measured using a photoplethysmography (PPG) optical measurement method. PPG is a noninvasive technology that uses light sources (green, red and infrared) and photodetectors at the surface of skin to measure the volumetric variations of blood circulation. Blood pressured with the sphygmomanometer using an algorithm in which the cuff is slowly inflated while simultaneously sensing oscillations are no longer detected, the cuff deflates rapidly, and the signals are processed to determine systolic and diastolic pressures. The vital sign measurement device communicates with a mobile application via wireless Bluetooth Low Energy (BLE) communication. The hinlab mobile application displays the blood pressure, SpO2 and pulse rate measurements.

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network. Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including: - Server Software Health Level seven (HL7) Interface Software Options - - -American society for testing and materials (ASTM) Stat Lab interface - -Developer Tools - Pager Interface - - -Alarm history database - -Time master functions - -12-lead electrocardiogram (ECG) export Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application. The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow. Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments. Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems. The subject device is compatible with Infinity Central Station Wide version VG5.0

Biofourmis Everion+ (G2) provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: - · Pulse rate - · Respiration rate - · Movement - · Skin temperature Biofourmis Everion+ (G2) also provides Blood oxygen saturation (SpO2) as a vital for continuous data collection in adults, 18 years of age or older, when at rest. Biofourmis Everion+ (G2) is intended for use in a hospital or home environment to support monitoring of wearers under the care of a trained healthcare professional. Biofourmis Everion+ (G2) is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

The Biofourmis Everion+ (G2) is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for patient monitoring. The system is comprised of the following components: - . Wearable device with multiple sensors - . Secure cloud environment with an API - Charger with accessories - . Armband The Everion+ G2 wearable is battery-operated with integrated sensors and wireless transceiver. The device is reusable and considered multi-patient use. After a healthcare professional (HCP) prescribes a device to a patient, they can clean the device according to the accompanying documentation for normal expected wear and buildup on the device. When the patient no longer needs the device for remote monitoring, the device can be returned to the HCP and undergo a low-level disinfection process, so it can be prescribed to a new patient. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The patient contacting components primarily involved in permanent contact are the bottom device housing and the armband. The wearable continuously gathers multiparameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver. When not in range, the collected data is stored on the Everion+ G2 wearable and transmitted when connection has been restored. Through APIs of the cloud environment, the data may be accessed from the cloud storage or integrated into a third-party application for monitoring.

The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals. The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms. The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device. The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old): - Pulse rate - Oxygen saturation - Temperature - Movement The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old): - Respiration rate. The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of: - Non-invasive blood pressure - Lung function & spirometry - Weight The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms. The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor. The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.

The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode. Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only. The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP). The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server. The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring of: - · Respiration rate - · Non-invasive blood pressure - · Lung function & spirometry - · Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs. The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals. The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.

The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can: - · Admit and discharge patients on the Nihon Kohden network. - · Display and manage compatible devices' real-time patient clinical data. - Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected. - · Review and trend data calculated by connected Nihon Kohden devices. - · Store and transfer historical clinical data for the connected systems. - · Print patient data. The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

The CNS-2101 central monitor is a central monitoring device designed to support medical personnel to provide medical care to multiple patients at the same time. It acquires vital sign data from multiple monitoring devices such as bedside monitors and displays the acquired data such as ECG and pulse rate on the screen as well as informing alarms. The CNS-2101 can communicate with other devices through a network connection. The CNS-2101 can acquire vital sign data directly from multiple monitoring devices (e.g., bedside monitors) connected to Nihon Kohen Monitoring device network or using multiple patient receivers and transmitters, or by a combination of both methods. The parameters to monitor on the central monitor can be changed as necessary by selecting a monitoring device such as a bedside monitor or transmitter and changing the parameter settings for that device. The CNS-2101 is designed to be installed in a location outside the patient environment such as a nurse's station for central monitoring.

Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest: - Pulse rate - Respiration rate - Movement The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.

The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring. The system is comprised of the following components: - Wearable device with multiple sensors - Secure cloud environment with an API . - Charger with accessories . - Armband . The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver.

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults: - · Pulse rate - · Oxygen saturation - · Temperature - Movement The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of. - · Respiration rate - Non-invasive blood pressure - · Lung function & spirometry - · Weight The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor. The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

The Current Wearable System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs. The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals. The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.