Instructions for Use

1.0purpleDx

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2.0User Manual / Instructions for Use

These Instructions for Use are supplied electronically. A paper format is available on request. To receive a hard copy of the Instructions for Use please email admin@electronrx.com with the designated address.

Please read these Instructions carefully before using the application.

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3.0Intended Use

purpleDx is a smartphone-based heart rate and respiratory rate measuring application designed for use by non-healthcare consumers in the home environment. It is suitable for use by adults.

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4.0Indications for Use

Both male and female, aged 16 years and above, with skin tones I to IV on the Fitzpatrick Scale. As a general heart rate and respiratory rate application, the system is not intended to diagnose or monitor any specific medical conditions.

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5.0Environment

The application is intended to be used by the patient in a non-specialised environment.

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6.0Limitations

The following limitations apply to measurements given by the application:

• heart rate can only be measured in the range of 50 to 120 beats per minute;

• heart rate measurements are accurate to ±5 beats per minute or ±15%, whichever is highest;

• respiratory rate can only be measured in the range of 6 to 20 breaths per minute;

• respiratory rate measurements are accurate to ±10% or ±2 breaths per minute, whichever is highest.

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7.0Contraindications

There are no known contraindications.

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8.0Warnings

• You must not use this app to make any medical decision, including altering your medication or treatment.

• You must seek professional medical advice before making any medical decision.

• purpleDx cannot detect any event or conditions, including but not limited to heart attacks, ischemic conditions, and respiratory conditions. If you experience any symptoms, seek professional medical advice. If you experience symptoms of heart attack (including chest pain, pressure, or tightness), call emergency services.

• purpleDx is not intended to detect or diagnose any specific condition, including but not limited to atrial fibrillation or lung conditions.

• Do not use purpleDx in a critical care situation.

• Do not use the application while driving.

• The application is not to be used by patients under 16 years old.

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9.0Precautions

• Do not clean with solvents.

• purpleDx is only intended to be used on the following devices:

  • iPhone 15

  • iPhone 15 Plus

  • iPhone 15 Pro

  • iPhone 15 Pro Max

  • iPhone 14

  • iPhone 14 Plus

  • iPhone 14 Pro

  • iPhone 14 Pro Max

  • iPhone 13 mini

  • iPhone 13 pro max

  • iPhone 13 pro

  • iPhone 13

  • iPhone 12 mini

  • iPhone 12 pro max

  • iPhone 12 pro

  • iPhone 12

  • iPhone SE (2022)

  • iPhone SE (2020)

  • iPhone 11 pro max

  • iPhone 11 pro

  • iPhone 11

  • iPhone XR

  • iPhone XS max

  • iPhone XS"

• purpleDx is only intended to be used on iOS versions 16 and 17.

 

The following factors may affect the accuracy of measurements made using purpleDx:

 

• not to be used by people with skin tones V or VI on the Fitzpatrick Scale.

• not to be used by patients with facial tattoos.

• to be used if the face is obstructed e.g. by hats, glasses, beard etc.

• not to be used whilst wearing makeup that could obscure the skin.

• not to be used by patients with a disability that prevents them performing measurements according to the Instructions for Use.

• Do not perform measurements if the camera lens is unclean or broken.

• not to be used by patients with reduced blood flow to the face.

• not to be used in light levels outside of the range 250 – 1500 lux. Here are some examples of these light levels in practice:

  • 250 lux - well-lit indoor spaces with artificial ceiling lighting and low external light through windows

  • 1500 lux - well-lit indoor spaces with direct white LED illumination with some indirect sunlight through windows

 

10.0Serious Incident Reporting

Any serious incident that occurs in relation to purpleDx should be reported to electronRx and the Medicines & Healthcare Products Regulatory Agency (MHRA).

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11.0Instruction Manual

11.1Pages Navigation and information

11.1.1Login page - The Login Screen is allows users to access their account securely. To log in:

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12.0Open the App – Launch purpleDx on your device.

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13.0Enter Email – Type your registered email address in the Email field. Ensure that the email is correctly formatted (e.g., user@example.com).

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14.0Enter Password – Input your secure password in the Password field. Passwords are case-sensitive.

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15.0Login – Tap the Login button to access your account.

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16.0Forgot Password? – If you cannot remember your password, tap "Forgot Password?" and follow the instructions to reset it.

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17.0New Users – If you do not have an account, tap "Sign Up"  to register for a new account.

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For security reasons, repeated failed login attempts may result in temporary account lockout. Ensure your credentials are entered correctly.

17.1.1Create an account

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The Sign-Up Screen allows new users to create an account. To create a new account:

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18.0Open the App – Launch purpleDx on your device.

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19.0Enter Email – Provide a valid email address in the Email field. The email must be correctly formatted (e.g., user@example.com) and not already associated with an existing account.

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20.0Create a Password – Enter a secure password in the Password field. Passwords must meet security requirements (at least 8 characters long, at least one upper case and one lower case, a number and a special character).

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21.0Agree to Terms & Policies – Read and accept the Terms & Conditions and Privacy Policy by checking the provided box. You can read Terms & Conditions and Privacy Policy by clicking on the hyperlink links. You must agree to proceed with account creation.

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22.0Sign Up – Tap the Sign Up button to create your account.

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23.0Once registered, you can log in using your email and password.

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23.1.1Home Page

The Home Page serves as the main navigation page to access key features and information quickly.

 

From the bar menu, users can:

 

• Access Instructions for Use – Tap the "Instruction" button to view the Instruction for Use (IFU) document, which provides guidance on using the app’s features.

 

• Manage Profile & App Information – Tap the "Profile" button to access your user profile and app-related details an information. And account settings and preferences.

• Return to Home – Tap the "Main" button at any time to navigate back to the Home Page

 

From the Home Page, users can also start a new measurement by tapping the "Measurement" button.

           

Important Note: If the app is being used for the first time, a dialog box will appear requesting camera permissions. Users must accept camera access to enable measurement recording. If permission is denied, the measurement feature will not function.

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23.1.2 Instructions For Use Page

The Instructions For Use Page shows all the instructions on how to use the app to take a recording.

Use the back arrow button to navigate back to the Welcome Page.

 

23.1.3Profile Page

The Profile Page allows users to manage their account settings, access important legal information, and perform account-related actions.

• Access Terms & Conditions – Tap the "Terms & Conditions" link to review the app’s usage policies.

• View Privacy Policy – Tap the "Privacy Policy" link to understand how your data is collected, stored, and used.

• Learn About electronRx – Tap the "About" section to view information about electronRx and services.

• Log Out – Tap the "Log Out" button to securely sign out of your account.

• Delete Account – Tap the "Delete Account" option to permanently remove your account and associated data. A confirmation will be required to proceed.

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Note: Once an account is deleted, all associated data will be permanently erased and cannot be recovered. Ensure you have backed up any important information before proceeding.

 

23.1.4Terms and Conditions

The Terms and Conditions Page contains information about the app usage policies that will need to be agreed to use the app.

Use the “Done” button at the top left corner to navigate back to the app. The full content can be read by scrolling down to the bottom.

 

23.1.5Privacy Policy

The Privacy Policy Page contains information about how data is collected, stored, and used. Privacy policy  will need to be agreed with the Terms and Conditions to use the app.

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Use the “Done” button at the top left corner to navigate back to the app. The full content can be read by scrolling down to the bottom.

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23.1.6Guide Pages

The Guide Pages display an instructional guide for taking a good recording, each with an image demonstrating the correct procedure.

The top left of the page has a back arrow button that navigates back to the Home Page. Use the “Start” button to progress to the Recording Page and take a recording.

 

23.1.7Recording Page

The Recording Page displays when a recording is being taken. The pages display the camera output with user feedback indicators overlaid. See Section 11.2 for recording tips.

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The recording page is overlaid with an oval window to guide the user for optimal face location. Use the back button in the top left corner to stop the recording and navigate back to the Guide Page. Text may appear on the screen to help with taking the recording. The text may be one of the following: “Starting”, “Face Too Far Away”, “Face Too Close”, “Face Not In Oval”, “Face In Oval”, “Face Detected”, or “Camera Waiting For Your Face”. The progress bar indicates the relative time remaining to complete the recording. Three statements at the bottom indicate checkpoints reached in the recording: “Recording Started” and “Recording Finished”.

A completed recording will automatically take the user to the Results Page.

 

23.1.8Results Pages

The Results Page displays the recorded measurement results, including:

 

• Average Heart Rate (HR) – Measured in beats per minute (BPM).

• Average Respiratory Rate (RR) – Measured in breaths per minute.

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Important Note:

If the recording quality is insufficient, the app will display a message indicating that the signal quality was low and that the measurement should be repeated for accurate results.

 

Use the "Finish" button at the bottom of the page to navigate back to the Home page.

 

23.2 

23.3Tips for Taking A Good Recording

This section describes the steps required to increase the likelihood of taking a good recording and reduce unnecessary complications regarding receiving an accurate and reliable result.

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23.3.1 

1. Take recordings in a well-lit room.

2. Remove any hats, sunglasses or any other items of clothing that could prevent the camera from seeing your face.

3. Wear minimal or no makeup, or anything else on your face that could prevent the camera from taking an accurate recording.

4. Make sure the front camera lens is clean and unobstructed for the clearest possible image.

5. Place your face within the oval on the screen at the start of the recording and keep it in the same location for the entirety of the recording.

6. Do not speak or make any facial movements.

7. Stay focused on the recording and remove local distractions to reduce the risk of unexpected movement.

8. Stay as still as possible. The best way to do this is by taking the recording in a seated position with your elbows and back resting against the seat.

9. Keep the camera still during the recording. This is best done by using a phone stand or supporting it with an object on a table.

10. Retake the recording and start again if, at any point in the 60 second recording window, you think that the quality of the recording has been affected.

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24.0General Information

Explanation of Symbols

 

 

BOX TO BE ADDED

 

25.0Manufacturer Details:

Name of Manufacturer

electronRx Ltd.

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Manufacturer Website

www.electronrx.com

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Address of Manufacturer

28 Chesterton Road,

Cambridge,

CB4 3AZ,

United Kingdom

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Customer Support

admin@electronrx.com