Search Results

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 Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety. The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users. The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety. The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users. The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety. The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users. The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. The device is not intended to be the sole method of checking the physical health of a subject.

The device is a software algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. These images can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest. Video is collected through video cameras installed in each room. When run through proprietary software-controlled algorithms, the software will allow a user to make spot checks for pulse and estimated breathing rates (chest wall movements) of the individual in the room. This allows vital monitoring without disturbing the patient either to allow for patient rest or to protect staff that would otherwise need to enter the room with a potentially dangerous patient. Off-the-shelf components must meet specifications set by the sponsor in order to ensure they will provide adequate quality video capture for analysis by the medical device.