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The TeleRehab® Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular and/or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System ("Aermos") provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients. Patients' ECG may be monitored using the Aermos system during exercise under clinical supervision. During monitoring, Aermos provides both visual and audible alarms if the patient's heart rate goes out of a prescribed range. The heart rate alarm indication is one of multiple inputs a clinician may use to modify and adjust rehabilitation activities such as decreasing the patient's level of physical exertion or halting the exercise entirely. Aermos also provides the ability to plan a patient's rehabilitation program and document the patient's progress through the creation of various types of reports. The report types supported in Aermos include individual treatment plan reports, daily exercise session reports and various patient information reports. Additionally, the Aermos system provides the ability to transfer various report types to the hospital Electronic Medical Records system. The main components of Aermos are Argus ECG transmitters, the Aermos Workstation and associated networking equipment.

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.

The UbiqVue 2A Multiparameter System is a wireless remote patient monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include electrocardiography (2-Channel ECG), heart Rate, SpO2%, respiration rate, pulse Rate, photoplethysmography waveform, skin temperature, body posture, body motion, R-R Interval, heart Rate variability (HRV) and blood Pressure (optional). Data is transmitted wirelessly near real time from UbigVue 2A Wearable Biosensor and 3rd party device (for Blood Pressure only) to remote central server for display, storage, and analysis. The UbiqVue 2A Multiparameter System is intended for non-critical, adult population. The UbiqVue 2A Multiparameter System shall include the ability to notify healthcare professionals through alerts when physiological parameters fall outside the set limits, manual trigger by the patient and to display multiple patient's physiological data for remote monitoring at home and with visual alarm for active monitoring at hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

The UbiqVue™ 2A Multiparameter System is similar to LifeSignals Multiparameter Remote Monitoring Platform that is cleared under K202868 but upgraded with monitoring of additional physiological parameters, minor performance improvements and additional User Interface. The UbiqVue™ 2A Multiparameter System consists of following components: - 1) UbiqVue™ 2A Wearable Biosensor - 2) UbigVue™ Single Patient Relay - 3) UbiqVue™ Multi-Patient Relay - 4) UbiqVue™ Central Server - 5) UbiqVue™ Active Monitoring Portal - 6) UbiqVue™ Relay Bridge Software (optional) - 7) UbiqVue™ Bluetooth Gateway Software (optional) - 8) Third-party Blood Pressure device (optional) The UbigVue™ 2A Wearable Biosensor when attached to body acquires two channels of ECG signals, TTI respiration signals (one of the inputs for deriving Respiration Rate), resistance variation of a Thermistor attached to body (used for deriving Skin Temperature) & accelerometer data (input for deriving Respiration Rate & Posture), pre-processes them and wirelessly transmits to a paired Relay device, as cleared under K202868. Following are additional features proposed in this submission: - Ambient temperature sensor for Body temperature derivation. - Acquisition of PPG (Photoplethysmography) signals using the integrated Optical sensor array. - Derivation of SpO2% and Pulse Rate within the Biosensor, based on PPG signals acquired through the Optical sensor array. Biosensor uses standard WLAN (802.11b) secured (AES) communication protocol for wireless data transmission to the Relay Device, as cleared under K202868. The Biosensor is also additionally integrated with BLE Radio for communication with Single Patient Relay device. As cleared under K202868, when Relay device is available within the wireless range, the acquired data is continuously transmitted to the Relay device immediately. If Relay device is not available or if there is any interruption in the communication between Relay device and Biosensor, data shall be temporarily buffered locally in Biosensor till the wireless connection is re-established. The UbigVue™ Single Patient Relay Device, a standard Mobile device or custom device that is installed with a UbigVue Single Patient Relay Application software, that receives the physiological data transmitted from any paired Biosensor. It shall transmit the data received from the Biosensor, immediately without any day to Central Server that is configured to receive, after necessary data encryption. The Single Patient Relay Device shall receive data from Biosensor either through WLAN or BLE and transmit it to Central Server using its mobile data network (3G, 4G, LTE, 5G, etc.) Single Patient Relay Device function is identical to the one cleared under K202868, except it is upgraded to support additional parameters & also improvements in GUI as below: - To handle additional data packets of Biosensor such as Ambient Temperature, PPG signals. SpO2% and Pulse Rate. - Interactive GUI that provides feedback to Users about the signal quality of PPG signals to identify the optimal body location for affixing the Biosensor. - Shall pair with a 3rd party Blood Pressure device using BLE and transfer the data to the Central Server. - Allows User to enter Oral Temperature reading (for calibration) and/or manual Blood pressure data (optional if no 3td Party device is connected). The UbiqVue™ Multi-Patient Relay Device (MPR) is an UbiqVue™ Multi-Patient Relay Application Software installed in a standard Linux platform (Physically or in cloud), that has ability to pair & receives data from multiple Biosensors, through wireless access points (WLAN) connected in its network. It shall transmit the received data from Biosensors to Central Server that is configured to receive through internet or private network (VPN), after necessary encryption & authentication. Multi-Patient Relay Device also receives data from multiple third-party Blood Pressure devices worn by the patients & connected to its network (through BLE gateway). If the Central Server is not available or there is no connectivity, the data shall be temporarily buffered securely in the MPR device itself. There is no GUI component for this software application. The UbigVue™ Central Server is UbiqVue™ Central Server Application software installed in a compatible Linux Server hardware Platform. The Central Server Application functions are also identical to Secure Server Application in LifeSignals Multi-parameter Remote Monitoring Platform (K202868), other than being upgraded to handle additional parameters. Also, the "Sensor Processing Library", the algorithm that derives various vital parameters is upgraded for performance improvements. The following are additional features: - Extending the minimum skin temperature measurement capability from 32.0℃ (89.6 °F) to 15.0°C (59.0°F) - Body Temperature estimation using Skin Temperature, Ambient temperature, Heart Rate (based on clinical condition) and Activity. - Uses the Oral Temperature entered manually for initial / periodic calibration of derived Body temperature. - Additional Posture classification & Body motion detection capabilities. - Improvements in Respiration Rate & Heart Rate derivation algorithm. - Integration with 3rd Party beat analysis & classification software for deriving Sinus Heart Rate, R-R Interval & Heart Rate Variability. - The PPG Signal Quality Index (SQI) algorithm module for displaying the SQI on the Active Monitoring dashboard & to access the quality of SpO2 value derived by the Biosensor. - Support for Early Warning Score (NEWS2) calculation. Central Server shall have ability to send alert notifications to any configured one or more Users through E-mail, SMS or WhatsApp, for any Clinical, Technical or Manual Alert conditions, as cleared under K202868. However, this alert engine is upgraded to support additional parameters and improved configuration capabilities such as Acknowledgement, priority & condition delay time. Active Monitoring Portal in UbiqVue™ 2A Multiparameter System is identical to Web UI in LifeSignals Multi-parameter Remote Monitoring Platform cleared under K202868. It is a browser-based User Interface Application that enables Clinical personnel to login to the Central server remotely and access the patient physiological data (Biosensor & derived data) and view/Acknowledge the Alert(s). The Clinical personnel, depending on the roles (normal or supervisory) can access data of multiple patients assigned to them and search them based on the recent alert status. This includes patients that are active (wearing Biosensor) and monitoring procedures completed. It is in-built with a Monitoring Dashboard that continuously displays physiological parameters, waveforms & alert status of any assigned patients to any authenticated Clinical personnel for (quasi) real time Active Monitoring. It has the option for the User to select multiple patient tile view or Single Patient Zoom View/Hybrid view of any patient based on multiple available filter settings. Following are the few changes in this 510(k): - Additional parameters (SpO2%. PR, EWS, SYS, DIA, MAP, PPG, SQI, EWS). - Visual alarm display for any Clinical, Technical, or manual alert/alarm. - Hybrid tile view (Zoom View + Tile view) and Group tile view. - Multi-level User Management, roles & privileges. Note: Any Third-Party Application / Server may communicate with UbiqVue™ Central Server using a defined set of Application Programming Interface (API) for entering patient information, configuring & generating customized report or any other requirement that does not alter the intended use of the system (e.g., EMR/EHR, HIMS) or to meet the additional intended use claimed by the third-party application. UbigVue™ Active Monitoring Portal shall continue to be used for the claimed Active Monitoring intended use. However, UbiqVue™ Active Monitoring portal may be optional for integration with any other regulatory approved monitoring dashboard or different intended use claims. Relay Bridge Software in UbiqVue™ 2A Multiparameter System when installed in a standard OpenWrt based routers, shall provide communication between Biosensor(s) & Multi-Patient Relay. Relay Bridge is an alternate for a standard access point and is intended when Multi-Patient Relay Software is hosted in the cloud. Similar to standard access point, the Relay Bridge communicates with multiple Biosensor and transfers the data to the Multi-Patient Relay without buffering the data. Since the Relay bridge transfers the data to the designated Multi-Patient Relay bridge in the cloud, it further encrypts the data for securely transmitting through the internet via ethernet, Wi-Fi or cellular network. Bluetooth Gateway Software in UbigVue™ 2A Multiparameter System when installed in a standard OpenWrt based BLE gateway or BLE supported routers, shall provide communication between 3rd party BLE devices (e.g. BP device) & Multi-Patient Relay. Bluetooth Gateway communicates with multiple 3rd party devices and transfers the data to the Multi-Patient Relay without buffering.

The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active. The Device is not intended for critical care.

The BioButton System (the "Device") is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the Device for storage and analysis. The Device is an extension of the Predicate Device (K212957) with the same intended use. The Device consists of a multiple-use and rechargeable wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. The main components of the Device include the following: 1. A wearable sensor to collect data from a patient 2. A device-based Medical Device Data System (MDDS) data gateway to transfer data from the wearable sensor to the cloud 3. A cloud-based Medical Device Data System (MDDS) for data storage and transmission 4. A cloud-based system for configuration of the wearable sensor and data analysis 5. A cloud-based system for healthcare professionals to view patient information The Device is used to collect physiological information from a patient using the sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest. The medical physiological data collected includes: - Heart rate at rest, - Respiratory rate at rest, and - Skin temperature There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the regulatory submission since they do not meet the definition of medical device. Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. The Device also provides a web display for healthcare professionals to view patient information.

The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.

The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.

ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate. SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.

ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. 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-Tompkins 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 skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements.

The function of the device is the acquisition and transmission of the ECG signal in order to support diagnosis of the patient's conditions. HD+ is a wireless or USB (with appropriate option) ECG acquisition device, to be used primarily as common front-end for standard PC/tablet platforms (Windows/MAC OS/others), for resting ECG applications. The device implements wireless communication vireless technology or wired with USB communication. With both connection modes, HD+ sends the data to the receiver device without performing any analysis or filtering. HD+ is not intended for monitoring of the cardiac function or to diagnose the patient's health condition. Display, print and analysis applications on the receiver device are separate products. HD+ is not able to permanently store the acquired data, therefore it does not work unless a connection has been established with a receiver application. Furthermore, HD+ does not collect any of the patient's name, age, previous health conditions etc.). HD+ detects the QRS complexes and transmit the receiving device. The QRS detection function is intended for patients aged 12 years or older. *HD+ is indicated for the acquisition of ECG signals with the patient in resting conditions, for example for diagnostic ECG's and rhythm strips *HD+ is suitable for working at high altitudes, with restrictions. *HD+ is intended for use on patients, with no limits of age or gender, except for the HR detector function which is intended for patients 12 years or older * HD+ is intended for use in medical facilities (hospitals, clinics), at home or emergency settings (ambulances). *HD+ is intended for use by a physician, nurse or other healthcare professional (e.g., ECG technician) who acts following orders by a physician or authorized nurse, including when operated in home environments *HD+ is not intended for real-time monitoring of vital physiological parameters.

HD+12 and HD+15 are the new revisions of Cardioline's HD+ wireless acquisition module. The HD+ is a digital portable acquisition device which can acquire the electrocardiographic signal of 12 and 15 standard leads. Connected with a receiver via Bluetooth or USB (with the optional USB connector), the HD+ performs no analysis or filtering but sends acquired data to a host application where the User Interface is implemented. By default, the device includes a demo compatible software "HD+ Display" whose purpose is providing a UI for viewing the traces acquired by HD+. HD+ Display provides a simple UI, sufficient to configure the application to connect to an HD+ device via Bluetooth (the application automatically detects if an HD+ device is connected via USB and does not require additional configuration) and sufficient to display the ECG traces as received by HD+. HD+ Display does not provide any clinical functionality; therefore, it does not provide any capability to store, print or analyze the acquired ECG. lt is the host (PC or Tablet separated by HD+) which performs the analysis. HD+ is not intended to control or analysis heart function and/or to diagnose the patient's health status. The analysis program on the host is a separate product not marketed with the HD+. HD+ is a wireless acquisition device, to be primarily used as ECG front-end acquisition device for PC/tablet (Windows/MAC OS/Android/iOS/others) standard platforms for Resting ECG applications. Depending on performance/price ratio, HD+ could be also used with selected embedded electrocardiographs. HD+ allows the patient to be ambulatory. HD+ uses a standard Bluetooth data transmission technology to transmit 12-lead and 15-lead ECG data over a proximity range, providing electrical insulation and freedom of movement for the patient. The device implements the wireless communication via Bluetooth wireless technology. The Bluetooth radio protocol is implemented by a dedicated module, FCC compliant. In order to support the data transmission speed of the application, the device implements the BLE 5 protocol with DLE (Data Length Extension) and 2M PHY (bandwidth up to 2 Mbit/s). The minimum specifications of the device connected to HD+ is BLE 4.2 to support the band required by acquisitions at 500 s/s. In order to operate at 1000 s/s, the connected device must be BLE 5.0 (or higher) and have a compatible 2M PHY radio (2 Mbit/s). Alternatively, in addition to Bluetooth connectivity described above, the HD+ has an optional USB interface that can be used to transmit data. The USB interface provides an electrical insulation offering two means of patient protection (2MPP), allowing HD+ to be connected to any IT equipment conforming to IEC 62368-1. The HD+ function consists of acquiring and transmitting ECG signals for display processing ECG signals for the purpose of supporting the diagnosis of patient conditions. The device does not store nor does it associate patient identification data to the acquired signal, nor does it perform analysis on such signal. The HD+ is used solely for transmission of ECG signals from patient to a host analysis platform. The HD+ transmits a continuous stream of ECG samples at a rate of 500 s/s or 1000 s/s, with a resolution of 0.817 uV/LSB or 2.495 uV/LSB, selectable by the calling application of the host analysis platform. The average required transmission throughput for sending 15 leads at 1000 s/s is approximately 155kbit/s, while to send 12 leads at 500 s/s the required throughput is approximately 54 kbit/s. BLE 5 2M PHY provides the bandwidth needed to support the maximum required throughput. The BLE communication link ensures that data is either received correctly or not received at all. It is up to the host application to detect packet losses, handling the data gaps appropriately (e.g. by filling the stream with invalid dummy samples, signaling transmission errors etc...). This approach has been preferred over enabling the data retransmission (supported by the module) to reduce the data iitter and transmission delay. HD+ uses standard 12 lead or 15 lead ECG cables to acquire the physiological signal from the patient. HD+ is light and compact, comfortable to wear, minimizing motion artifacts caused by traditional electrodes and patient cables. HD+ offers full ECG acquisition - meeting the standards used in clinical and diagnostic applications (AAMI, ANSI, AHA, ACC). HD+ uses a LED indicator to comfortably monitor the link status (off when unit is powered down, blinking when unit is attempting to connect with the receiver, steady when unit is connected with the receiver). HD+ uses a programmable key to send macro commands to the receiving system (i.e. acquire and print an ECG). Low-power technology allows continuous usage of the device for more than 10 hours (from full battery charge). The HD+ continuously transmits the acquired data to a computer platform where compatible software, a Host Application authorized by Cardioline, is installed that acts as its User Interface. As an example of such Host Application, the device includes a compatible demo Windows application "HD+ display" from Cardioline to visualize the ECG traces and check the functionality of the results of the analysis must always be validated by qualified, trained medical personnel and the HD+ is intended for use in a medical environment. HD+ is intended to be used on adult and all pediatric patients. The device must be handled with care by taking all the necessary precautions in order to prevent and avoid shocks, vibrations, heat sources, liquids and anything else that may damage it.

Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review. The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values. Alio is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the patient having an abnormal potassium level. The SmartPatch sensor is indicated to record and transmit auscultation sound data. For qualitative assessment of abnormal potassium levels, and quantitative measurement of heart rate, skin temperature, Hgb and Hct, the SmartPatch should be placed on an arm based arteriovenous access on patients with end stage kidney disease (ESKD). Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. Therapeutic management decisions, including management of dyskalemia, should be made based on a complete assessment of the patient's condition and should not be based solely on Alio.

Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. Alio is intended to be used on general care patients and patients with end stage kidney disease (ESKD), who are 18 years of age or older in clinical and non-clinical settings. Alio includes the following components: Alio SmartPatch: The Alio SmartPatch is a flexible, silicone-encased patch designed to be worn between the cannulation sites of the arteriovenous (AV) fistula or graft for up to seven days. It houses numerous sensor technologies which collect data for the derivation of physiologic parameters including hemoglobin, hematocrit, an assessment of normal or abnormal (hyper or hypokalemic) levels of serum potassium (K+), skin temperature, auscultation sound data, and heart rate. The data from the sensors is transmitted from the SmartPatch to the Alio Hub via a bluetooth connection. The data is then transmitted to the Alio Cloud, via the Alio Hub, where it is analyzed and made available to a clinical care team via the Alio Portal. Alio Hub: The Alio Hub is designed for use in clinical and non-clinical use settings. It automatically communicates with the activated Alio SmartPatch via Bluetooth and uploads physiological data to the Alio Cloud via cellular connection. Alio Cloud: The Alio Cloud allows clinicians to access patient data collected via the Alio SmartPatch and wirelessly transferred from the Alio Hub to the secure server (the Alio Cloud). Alio Portal: The Alio Portal stores data received from the Alio Cloud database that supports storage, analytics, system monitoring and visualization capabilities. This data is encrypted and HIPAA compliant. The Alio Portal also serves as the interface with the HCP who can then visualize and interact with data being generated by the system.

The Care Team Portal is intended to support management of health conditions. It allows a clinical user to configure the collection of patient data. The Care Team Portal includes the ability to notify the patient and the clinical user when the parameters fall outside set limits and customize patient specific recommendations.

Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices. The Care Team Portal allows the clinical user to view and manage patient information. The functionality includes the ability to add new users and patients, ability to schedule video visits, secure in-app messaging, configure the collection of patient data leveraging care pathways survey questions, educational content and videos with customized notifications, and prioritize patients. It provides a dashboard view of the patients being monitored. The patient portals enable the patient to provide subjective symptom or health status information that assists the care team in supporting the management of health conditions: +Home is an option that provides the patient with software pre-loaded on a tablet that allows them to navigate through care pathways for the collection of patient data and view educational content related to their health condition. +Go is designed for patients to download the software to their own mobile device to navigate through care pathways for the collection of patient data and delivery of educational content related to their health condition. +Voice allows patients to answer their pathways questions and enter data using their phone. Accessory devices can be connected to the system to allow for collection of vital signs or used independently to allow for manual input.

The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection from the device for storage, review, and further analysis. The data from the device are intended as an aid to diagnosis, diseases management, and treatment. The device is intended for use on users who are 18 years of age or older. The device is not intended to output physiological measurements while the user undergoes significant motion or is active. The device is not intended for critical care.

The BioButton System is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted from the BioButton for storage and analysis. The BioButton System (the System), is an extension of the BioSticker System with the same/similar intended use. The System is intended to monitor physiological parameters of the patient/users for relatively long duration (up to 60 days with medical data collection). The System should now enable the connectivity with the BioButton sensor device (BBN) with the rest of the system components. The BioButton System consists of a single-use wearable hardware sensor module to collect data from a patient and other Medical Device Data System (MDDS) components that enables remote transfer of collected data. See main components of the BioButton System. The main components of the BioButton System could include the following: - BioButton Sensor - - -BioButton adhesives (accessory) - Data Exchange Hubs (MDDS) - - -Cloud-based data platform (MDDS) The BioButton System is used to collect physiological information from a patient using the BioButton Sensor for a set duration (as defined by different use cases) in home and healthcare settings. Physiological data is collected continuously while the patient is at rest¹. The medical physiological data collected includes: - . Heart rate at rest, - . Respiratory rate at rest, and - Skin temperature ¹ "At Rest" means the device will not output measurement data to the user undergoes significant motion or is active. There are other wellness parameters that can be collected by the device that include: activity level, body position, sleep, and step and gait analysis. These wellness data types are not discussed in detail the requlatory submission since they do not meet the definition of medical device. Upon completion of a physiological data collection period, the data offload is conducted via wireless Bluetooth connection using the Offload Software. The data offloading is performed and qualified personnel. Also using the Offload Software, a report will be generated to be viewed by a healthcare professional. The report is not intended to be viewed by the patient.