Medical Device Information

Intended Use

The Oxehealth Vital Signs device is intended for non-invasive spot measurement of pulse rate and breathing rate. It is a fixed-installation device for use within single occupancy rooms within hospitals, general care, domestic and secured environments where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth Vital Signs device is indicated for use on humans 12 years of age or older with all skin types, who do not require critical care.

Contraindications

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

Warnings

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 breathing rate 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 breathing rate 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 breathing rate, or may give inaccurate measurements of pulse rate or breathing rate in the following circumstances:

• In subjects with tremor, alcohol withdrawal or motion disorders
• In subjects with pronounced sleep apnea
• 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 breathing rate is thus affected by the circumstances of the measurement. If it is not possible to take a Vital Signs measurement using Take Vital Signs, wait until the circumstances have changed then attempt another measurement using Take Vital Signs, or use another method for obtaining a measurement.

Oxehealth Vital Signs is not intended to give pulse rate or breathing rate measurements if a subject is moving and measurements may not be available or may be inaccurate if this is the case. Vital signs displayed by the Vital Signs Trends function may be affected in this way. When using the Take Vital Signs function, ensure that the subject is still before proceeding to obtain pulse rate and breathing rate measurements.

Oxehealth Vital Signs measures pulse rate and breathing rate from the skin and the body of a subject and measurements may not be available or may be inaccurate if suitable areas of the subject are not available. Vital signs displayed by the Vital Signs Trends function may be affected in this way. When using the Take Vital Signs function, ensure that Oxehealth Vital Signs is reading from the body before proceeding to take measurements.

The Vital Signs History and Vital Signs Trends charts display data gathered from a specified room so may show data for a subject who is not the subject currently occupying that room.

The Vital Signs Trends chart shows a summary of average vital signs to assist trend identification and cannot be used to measure or monitor pulse rate or breathing rate. To take a new measurement of pulse rate or breathing rate, use the Take Vital Signs function, or use other means to establish vital signs.

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 breathing rate 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.

If you make significant physical changes to a room, for instance visible structural changes or adding large items of furniture, this may affect the device performance and you should inform Oxehealth.

Specification

Disclaimer

The activity detection, activity report, fall risk, inactivity warning, location risk, and seclusion 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.