Medical Device Information

Indications for Use

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.
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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.

Warnings

The Oxehealth Vital Signs device must not be used with any subject receiving critical care.

The Oxehealth Vital Signs device must not be used in rooms that contain or may contain:

• Domestic animals
• A shower or significantly sized water feature

Oxehealth Vital Signs must not be used as the sole basis for making any decisions or recommendations relating to clinical diagnosis, subject care or treatment. Decisions or recommendations must be made by a clinician based on broader evidence than Oxehealth Vital Signs alone provides.

Cautions

If the Oxehealth Vital Signs device fails to respond as described, discontinue use until the situation has been corrected.  Contact Oxehealth for support through the user interface or at the telephone number or address given at the end of this manual. The Oxehealth Vital Signs device is designed to measure pulse rate and estimated breathing rate (chest wall movements) in the ranges specified, and will not give measurements outside these ranges.Oxehealth Vital Signs may not give measurements of pulse rate in the following circumstances:

• In subjects with low perfusion, anaemia, poor circulation or blood volume deficiency
• Where insufficient skin is visible to the Oxehealth Vital Signs device
• Where visible skin is significantly scarred or tattooed
• Where visible skin has excessive make-up, sunscreen or other topical applications that hide the underlying skin applied

Oxehealth Vital Signs may not give measurements of pulse rate or estimated breathing rate (chest wall movements) in the following circumstances:

• Where insufficient body area is visible to the Oxehealth Vital Signs device
• If the area of the subject is heavily saturated due to exceptionally bright illumination

Oxehealth Vital Signs may not give measurements of pulse rate or estimated breathing rate (chest wall movements), or may give inaccurate measurements of pulse rate or estimated breathing rate (chest wall movements),in the following circumstances:

• In subjects with tremor, alcohol withdrawal or motion disorders
• When subjects are talking or are controlling their breathing
• Large airflows through the room
• Other sources of movement in the image
• If another living being is present in the image (including hidden from view, for example by sheets)
• Running, dripping or spraying liquids in the image
• Moving patches of light or shadow in the image
• In the presence of sources of flashing or variable light, including other Near Infrared illumination, for instance from an existing CCTV installation
• Sources of mechanical vibration, for example massage devices, in the image
• Vibration of the Oxehealth Vital Signs camera, caused for example by drilling into a nearby structure at the time of the measurement.

The availability of pulse rate or estimated breathing rate (chest wall movements) is thus affected by the circumstances of the measurement. If it is not possible to take a Vital Signs measurement, wait until the circumstances have changed then attempt another measurement, or use another method for obtaining a measurement.

Oxehealth Vital Signs is not intended to give pulse rate or estimated breathing rate (chest wall movements) measurements if a subject is moving. In situations where a subject is moving when you are preparing to take pulse rate or estimated breathing rate (chest wall movements) measurements, do not proceed, but use other methods, or ensure that the subject is still before attempting to use Oxehealth Vital Signs to obtain pulse rate and estimated breathing rate (chest wall movements) measurements. Failure to do so may result in you obtaining no measurement or an inaccurate measurement.

Oxehealth Vital Signs measures pulse rate and estimated breathing rate (chest wall movements) from the skin and the body of a subject, and you must ensure that Oxehealth Vital Signs is reading from suitable areas of the body before proceeding to take measurements. Failure to do so may result in inaccurate measurements.

Please be aware that:

• The system provides an estimated breathing rate (chest wall movements), rather than end tidal CO₂. It is not a replacement for end tidal CO₂ measurements.
• The system is not intended to detect the presence or absence of arrhythmias or to report measurements during an irregular arrhythmia.
• The system is not intended to be used as a continuous vital signs monitor.
• The system is not intended to be used as an apnea monitor.
• The accuracy of Oxehealth Vital Signs outputs has not been studied in patients with neuromuscular disorders.

The Oxehealth Vital Signs device analyses video captured from a video camera within a room illuminated by a Near Infrared Illuminator to measure pulse rate and estimated breathing rate (chest wall movements) from the subject, and so obstruction of either of these parts of the device will severely compromise its operation.Oxehealth software and related hardware installed inside or outside the room environment is not to be installed or maintained by anyone other than an Oxehealth trained representative. Any attempt by a non-Oxehealth representative to interfere with the hardware, operating system administration or software configuration outside that described in this manual may result in damage to the device performance.

Specification

Disclaimer

The activity detection, activity report, fall risk, inactivity warning and location risk product modules are activity trackers and do not have a medical purpose or functionality. They are not patient monitors or vital signs monitors. They cannot be used to make a medical or clinical decision.

Further information

If you have any questions or need further information, please contact us at info@oxehealth.com or write to us at Magdalen Centre North, Oxford Science Park, Oxford, OX4 4GA.

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