Lifelight®

Instructions For Use

Symbols on the device and documentation

The symbols and labels that appear in this manual and within the application have the following meanings:

Symbol	Description
	Serial Number. The serial number for this device is: LLF-002.
	Catalogue Number. The Catalogue number for this device is: LLF-002.
	Consult Instructions For Use.
	Indicates the item is a medical device.
	Date of manufacture.
	Name and address of the manufacturer.
	Caution.
0123	Complies with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices.
	Name and address of the Authorised Representative in the European Union (EU)
	Name and address of the Authorised Representative in Switzerland
	Name and address of the Importer for the specified country/region/jurisdiction

Lifelight Intended Purpose / Indications For Use

Important notes on measurement vs monitoring:

Lifelight is not intended for continuous monitoring of blood pressure or pulse rate. It is also not intended for environments of use where continuous monitoring of blood pressure or pulse rate is required. Lifelight is intended only for spot check measurement of blood pressure and pulse rate.

Warnings and Statements that can appear on the app

Warning and statements can appear within the app or in this document.

The app is safe for patients and clinicians when used in accordance with the instructions and the warning statements presented in these Instructions For Use.

Before using the app, you must familiarize yourself with all warnings to ensure good measurement signal quality and usable measurements.

In addition to reviewing the general warnings presented in the next section, you must also review the more specific instructions found in the Preparation and Set-up, Taking a Measurement and Maintenance sections.

• Failure to understand and observe any warning statement in this manual could lead to poor signal quality and no measurements returned or inaccurate results.

Low Measurement Quality

Low measurement quality, leading to no results returned at the end of the measurement, can occur with one or more of the following causes:

Lighting

1. The subject (the person being measured) is poorly lit.
2. The subject is strongly lit from behind or above and not adequately from in front.
3. The background to the subject is very brightly lit.
4. A mirror or reflective surface is in the background of the subject.
5. There are strong shadows on the subject’s forehead and cheeks.
6. The light changes during the measurement. Other than flickering lights, this could be caused by people or objects moving in the background.

Movement

1. The device is moving too much during the measurement. If you can't hold the device still, avoid hand-holding the device and instead use a stand or steady the device against an object.
2. The subject may be moving too much such as talking or looking around during the measurement. (Blinking and slight movements caused by breathing should not affect MSQ.)
3. A subject with Tourette's syndrome may move during the measurement and so alternative measurement tools are recommended.

Other

1. There is not an adequate wifi or data connection to upload the data.
2. The subject does not have their forehead and cheeks visible.
3. The device lens is not clean.

What Lifelight does and how it works

Intended Benefits

Benefit 1. Lifelight measures pulse rate and blood pressure simultaneously.

Benefit 2. Lifelight provides pulse rate and blood pressure measurements in situations where contact-based methods are not possible or not desirable.

Benefit 3. Lifelight measures pulse rate and blood pressure without using a cuff or requiring any other device or instrument, including for calibration purposes.

Preparation and set up of Lifelight before taking a measurement.

Device preparation and minimum requirements.

• Lifelight is designed to work on a range of validated mobile devices. The list of validated devices can be found at https://lifelight.ai/validated-devices/ .
• Ensure the device’s operating system is up to date.
• No calibration is required.
• Make sure you are using the latest version of the Lifelight app.
• Ensure the device is adequately charged for your requirements.
• Ensure the device lenses are clean.

IT networks characteristics and IT security measures.

• Lifelight requires a stable connection to the internet to function.
• The minimum connection speed required is 0.128 mbps upload and 0.128 mbps download.
• For the software to run as intended, the connection to the Wi-Fi must be secure and protected from unauthorized access.

Keeping the device still.

• The device running Lifelight must be held as still as possible when taking a measurement.
• If the device is held in a stand resting on a surface, that surface should be free from movement or vibration.
• Ideal stands allow the device to be repositioned and angled to accommodate the different heights of subjects if used by an operator for multiple subjects.

Environment, lighting and special facilities.

• For optimum Lifelight results, the environment, room or space should be distraction-free and allow the subject’s face to be well illuminated.
• Ideal lighting conditions allow the subject’s face to be well lit without strong shadows. Multiple strong, diffuse light sources are ideal.
• Lifelight may function poorly if the subject’s face is lit from a single strong light source that creates strong shadows across the forehead and cheeks.
• Lifelight may function poorly if the subject is strongly backlit, and/or if the space the subject is in is strongly lit and the subject isn’t.

Subject – the person being measured.

• Lifelight is validated for subjects age 18 and above.
• Lifelight works by measuring skin colour from cheeks and forehead. Therefore these areas of the subject's face must be visible and well illuminated.
• Subjects should remove glasses, hats and headscarves if they obscure facial skin or create strong shadows.
• Subjects should arrange hair so that their facial skin is exposed and free from strong shadows.
• If it is safe to do so under clinical guidance, remove masks (such as oxygen masks) for the duration of the measurement.
• Some subjects are concerned that they are being videoed. Lifelight only uses the images taken with the camera to measure the numeric colour values of facial skin. It is only these numeric colour values that are used to calculate the vital signs. The images are discarded.
• Subjects should avoid food, caffeine, tobacco and alcohol for at least 1 hour before taking a measurement.
• Subjects should sit quietly for a few minutes before taking the measurement.
• Subjects should be relaxed with their back and feet supported and arms and legs uncrossed.

Taking a measurement

Ensure the preparation and set up steps described previously have been followed.

Enter your biometric information - sex, age and height

• Enter your age, height and sex then press submit
• For height, press cm/ft to change between metric and imperial units.
• Starting the reading won't be possible unless the biometric values are all completed.
• After you have entered your biometrics, you will be shown instructions on how to complete the Lifelight Measurement.

Taking a Measurement

• Centre your face in the screen and a white rectangle will appear.
• On screen guidance will help you position your face correctly as well as provide guidance on lighting and device motion
• When you are in the right position the Lifelight reading will start
• The reading will take 40 seconds. A countdown bar is displayed at the top of the screen to indicate how much time the reading has taken.
• Remain still for the duration of the reading.
• You can stop a reading at any time by pressing the cancel button at the bottom of the screen.
• Once the 40s is completed your reading results will be displayed

When to retake a measurement

Measuring degree of accuracy

Technical Description

Other

Troubleshooting / Precautions if malfunction

Decommissioning and disposal of the software.

The application can be deleted from the device using the standard method for deleting applications for the platform. In the circumstance that Lifelight is deleted, no information will be retained on the device.