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DCM is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. DCM is indicated for monitoring of adult patients only.

DCM is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients during sleep and in applications where quantifiable analysis of physical motion is desirable. The device is set up to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control data collection. The data stored on the device can be transmitted to the cloud for storage, and made accessible to healthcare professionals or researchers for further analysis. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The DCM system comprises a system of components: - wearable biosensor (PW010) - off the shelf mobile device (PW030) running the DCM mobile app (PW400) - cloud-based data storage and data processing (PW100) (back-end) - investigator dashboard (PW500) accessed through a web browser (front-end)

The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days). The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

The VERABANDTM is a compact, wrist-worn battery-operated wearable device intended for collecting a patient's motion data for assessing patient activity. VERABANDTM is intended to acquire and store data while being worn during normal activities and/or during sleep. The device consists of a wearable band with compact housing for battery-powered on-board electronics with an accelerometer. The recorded activity data is timestamped and stored in non- volatile memory for later retrieval. Downloaded VERABANDTM data can be post-processed based on the timestamp and magnitude of acceleration for reporting.

The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data. The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied. The Oxevision Sleep Device is software assessing video from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments. The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.

Oxevision Sleep is a software-only medical device (SaMD) that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed. The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy bed spaces within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient movement, activity and physiological sign data and then to obtain information on bed occupancy and sleep state from the analysis of this data. The device software automates recognition of sleep periods, generation of sleep reports, and their presentation in a graphical display for use by a healthcare professional.

The ActiGraph LEAP™ is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The ActiGraph LEAP™ is a wrist-worn wearable device intended to continuously record high resolution digital acceleration data associated with a patient's physical movement. In practice, a healthcare professional or researcher can prescribe the device to collect physiological data from patients in applications where quantifiable analysis of physical motion is desirable. Having physical characteristics like those of an electronic wristwatch, the device is set to collect data by the healthcare professional then placed on the subject's wrist. The device is designed to be worn during normal activities and/or during sleep over a period of days to weeks. The patient does not need to interact with the device to control the operation or data collection. The data stored on the device can be downloaded via USB or Bluetooth Low Energy and made accessible to healthcare professionals or researchers for further analysis. The ActiGraph LEAP™ device will be supported by accessories for recharging the battery and transferring data from the device. A USB Charging Dock with a three-foot USB A cable for both charging and data transfer to a PC using the supplied communication software. The USB Charging Dock connects to the recessed electrical contacts on the back of the device. An off-the-shelf international Wall Mount AC Adapter is also supplied for optional wall charging. The USB Charging Dock can be plugged into the Wall Mount AC Adapter's USB A port for charging the device. The device uses a high-resolution digital accelerometer to accurately measure linear accelerations in 3axes associated with the patient's physical movement. The accelerometer technology is a microelectromechanical system (MEMS) implemented as an integrated circuit. The accelerometer data is converted to a digital representation on the MEMS accelerometer and then recorded, with timestamp, to the device's on-board memory. The memory is an 8 Gb serial NAND flash capable of storing 30 days of accelerometer data under the default operating mode. The sample rate of the accelerometer is configurable at the following rates: 32Hz, 64Hz, 128 Hz and 256Hz. The LCD display indicates the battery level, current functional state of the device, and date and time. The device has a 30-day battery life under the default operating mode and can be charged using the USB Charging Dock accessory. The display does not provide feedback to the wearer/patient regarding data measures. There is a simple button on the side used to turn on the display so the wearer can read the date/time and button presses are recorded in the log. The device firmware executes on internal processors to control the device operations, display, and external communication protocols. The accelerometer sensor data can be downloaded from the device either via USB (using the dock) or via Bluetooth Low Energy.

The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for document associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.

The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.

ActTrust is a compact, ambulatory, battery-operated data recorder with physical characteristics similar to a small wristwatch. The ActTrust is intended for the acquisition and analysis of the physical activity of the body, peripheral temperature and light exposure during daily living and sleep. The ActTrust uses state of the art miniature electronic technology to measure the data and store these data within the device. The ActTrust require operational software to allow configuration, data download, storage and off-line analysis of activity data by a health care provider. The device is connected directly by means of a standard Universal Serial Bus connection for configuration and download.

The MotionWatch and PRO-Diary are compact, lightweight, body-worn activity monitoring devices that may be used to document physical movement associated with applications in physiological monitoring. The devices are intended to monitor limb or body movements during daily living and sleep. The MotionWatch and PRO-Diary can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. Additionally, the PRO-Diary has a built-in score pad that allows the wearer to subjectively assign and enter responses to pre-programmed questions. The score pad can be used as a substitute or in addition to the traditional written patient diary in conjunction with activity monitoring.

MotionWatch and PRO-Diary are compact, ambulatory, battery-operated activity recorders with physical characteristics similar to a small wristwatch. The MotionWatch and PRO-Diary are intended for the acquisition and analysis of the physical activity of the body during daily living and sleep. The MotionWatch and PRO-Diary use state of the art miniature accelerometer technology to measure movements of the limb or torso and store these data within the devices differ in that the MotionWatch incorporates an ambient light sensor whereby the PRO-Diary incorporates a display and score-pad to allow subjective inputs. The MotionWatch and PRO-Diary require operational software to allow configuration. data download, storage and off-line analysis of activity data by a health, care provider. The software can be run on an IBM-Compatible PC and the device is connected directly by means of a standard Universal Serial Bus connection for configuration and download. The MotionWatch and PRO-Diary utilize a motion sensor known as an "accelerometer" to measure the occurrence and degree of motion. The sensor is a solid state device with a digital output directly proportional to physical acceleration in 1, 2 or 3 axes of orientation. The acceleration data are processed into "counts" before being stored in the non-volatile memory of the device.

The SBV2 System is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over.

The SBV2 System is a device that monitors activity. It relies on the measurement and analysis of wrist movements to detect and characterize sleep/wake periods. The device allows some aspects of sleep derived from the analysis of activity to be reported. The SBV2 System is graphically depicted in Figure 1.

The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

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The Cadwell EasyNet Limb Movement Module is intended for use to detect periodic limb movements for recording onto a physiological recorder. It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

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