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Hypotension, or low blood pressure, is a medical condition in which the force of blood against the walls of the arteries is consistently lower than normal.
In some cases, it can lead to symptoms such as dizziness, fainting, and fatigue.
Hypotension can be caused by various factors such as dehydration, sudden blood loss, heart conditions, and certain medications. It is important to work with a healthcare provider to determine the cause and develop an appropriate treatment plan.
Risk Categories
Blood Pressure Categories
Steps to configure custom styling:
- Download the CSS template
- Modify the CSS template as needed (refer to class names and descriptions in the next section)
- Send the CSS file back to AHI along with any relevant assets
- AHI will provide confirmation when the CSS update is completed
CSS class names and descriptions:
For the main-body, we strongly recommend a light colored background, white or close to white. This will ensure the best scan results by helping to illuminate the face while avoiding additional unnatural color tints.
- header-logo - Customize the icon, note that customization provided here will override the value set by the config link.
- main-header - Customize the header of the page, a background color / image can be provided. display property can be set to none to hide the header completely.
- header-icon - Customize the color of the header icon, display property can be set to none to hide icon.
- main-body - Customize the background color / image of the main body of the measurement screen.
- measurementHelpButton - Customize the size and border color of the help button.
- start-camera-button - Controls the Start Camera button. This can be used to control the background / text color, the width of the button and the text style. In order to control the different states of the button, classes for :hover and :active can also be specified.
- measurement-canvas - Controls the background of the measurement canvas before the camera is started, a background color or image can be specified.
- start-measurement-button - Controls the Start Measurement button. This can be used to control the background / text color, as well as the width of the button and the text style. In order to control the different states of the button, classes for :hover and :active can also be specified.
- mobile-top-bar - Controls the background color of the toolbar at the top of the screen on mobile devices.
- mobile-top-bar-icon - Controls the color of the buttons in the toolbar at the top of the measurement screen on mobile devices.
- cameraSelectRoot - Controls the styling of the camera dropdown menu when unexpanded.
- MuiMenu-list - The background color of the camera menu list can be specified here.
- MuiMenuItem-root:hover - Controls the styling of the individual menu items of the camera dropdown menu during mouse hover.
- cameraMenuItem:focus - Controls the styling of the individual menu items of the camera dropdown menu when in focus.
Note: Additional styling and content options can be found in the next section.
Additional styling/content:
We provide the ability to display a header image above the camera selector (desktop view only). This allows you the option to flexibly include additional brand elements, designs and text in the form of an image.
How to use this?
- It is recommended to use an image with a width of 740px. The image height should be a maximum of 150px.
- Host the image on a server and share the URL with AHI.
- AHI will confirm once the image is attached to your scan page.
Why Are These Guidelines Necessary?
Both Google and Apple are uncomfortable with mobile phones being used as medical devices and do not allow applications that claim to provide medical device features on their market places.
Wellness and health guidance applications are generally acceptable. Specifically, applications that make claims that the phone can produce medical device results will have difficulty being accepted.
It is important that you do not make feature claims as part of your application description or screens that could be easily interpreted as being able to replace or behave like a medical device results.
When Submitting Your App:
- Do NOT expect to use the app store submission copy as a platform for marketing your app to the end-user. The app store is primarily a distribution tool not a marketing and sales tool.
- Therefore less is more – do NOT promote any specific wellness measurement “features” on your app-store submission copy (such as blood-pressure, CVD risks, metabolic risks etc.). Only say something like “ ….. to increase awareness of your general wellness”
- Whenever possible, reinforce that the submitted app is NOT intended nor promoted for use as a medical device
- Ensure that USA/CAN market users are excluded from (directly) accessing Blood Pressure results. Apps in these markets can consider displaying the results in terms of risk categories rather than numeric values, and state that these are only estimations. E.g. Estimated Hypertension Risk.
- REQUIRED: a (short form) medical disclaimer is always prominently visible BOTH on the app itself and the app-store copy content
Short Form Disclaimer Message
The AHI (short form) medical disclaimer (2 options):
For Investigational Use Only.
These numbers are only estimates and are not a substitute for the judgment of a health care professional. They are intended to improve awareness of general wellness”.
For Investigational Use Only. [Your App Name] is not a substitute for the clinical judgment of a health care professional. [Your App Name] is intended to improve your awareness of general wellness. [Your App Name] does not diagnose, treat, mitigate or prevent any disease, symptom, disorder or abnormal physical state. Consult with a health care professional or emergency services if you believe you may have a medical issue.
- We suggest the disclaimer is shown on every measurement results screen
- We recommend a separate disclaimer screen presented during the user onboarding UX
Long Form Disclaimer Message
Optional long form medical disclaimer to be hyperlinked in the app itself behind the short form disclaimer.
Not for Medical Purposes
OUR SERVICES ARE NOT INTENDED FOR MEDICAL PURPOSES. THE SERVICES DO NOT OFFER ANY KIND OF MEDICAL ADVICE AND ARE NOT INTENDED FOR ANY MEDICAL USE OR PURPOSES. OUR SERVICES ARE INTENDED FOR GENERAL WELLNESS ONLY.
THE ESTIMATIVE MEASUREMENTS (“MEASUREMENTS”) PROVIDED TO YOU OF PHYSIOLOGICAL AND PSYCHOLOGICAL STATES INCLUDING HEART RATE AND STRESS SHOULD NOT BE TREATED AS MEDICAL ADVICE. THE MEASUREMENTS WE PROVIDE TO YOU ARE NOT INTENDED TO BE UTILIZED FOR ANY MEDICAL PURPOSES OR TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE, AILMENT OR INJURY. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, YOU EXPRESSLY AGREE WE ARE NOT PROVIDING ANY MEDICAL ADVICE VIA OUR SERVICES. ALL CONTENT PROVIDED BY OUR SERVICES INCLUDING THE MEASUREMENTS IS NOT INTENDED TO BE AND SHOULD NOT BE USED IN PLACE OF (A) THE ADVICE OF YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS, AND (B) A VISIT, CALL OR CONSULTATION WITH YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS. SHOULD YOU HAVE ANY HEALTH-RELATED QUESTIONS, PLEASE CALL OR SEE YOUR PHYSICIAN OR OTHER HEALTHCARE PROVIDER PROMPTLY. IF YOU HAVE AN EMERGENCY, CALL YOUR PHYSICIAN OR YOUR LOCAL EMERGENCY SERVICES IMMEDIATELY. YOUR USE OF OUR SERVICES DOES NOT CONSTITUTE OR CREATE A DOCTOR-PATIENT, THERAPIST PATIENT OR OTHER HEALTHCARE PROFESSIONAL RELATIONSHIP BETWEEN [Brand/Business Name] AND YOU.
Accuracy
THE MEASUREMENTS PROVIDED TO YOU ARE BASED ON INDICATORS AND STANDARDS DEVELOPED BY [Brand/Business Name] ITSELF AND ARE ONLY FOR PERSONAL INFORMATION PURPOSES, WITHOUT ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED. WHILE WE MAKE EVERY EFFORT TO PROVIDE ACCURATE ESTIMATIVE MEASURES, WE MAKE NO WARRANTY AND DISCLAIM ALL RESPONSIBILITY AND LIABILITY FOR ANY ACCURACY, RELIABILITY, AVAILABILITY, SECURITY, COMPLETENESS OR CORRECT USE OF MEASUREMENTS, CONTENT AND ANY OTHER INFORMATION OR RESULTS YOU RECEIVE THROUGH THE SERVICES.
Regarding Smartphone Device Camera:
- You should stress that the submitted app simply uses the device camera “ …. for its intended purpose”
- The device camera is used only to generate a 30-second “selfie” video
- The 30-second “selfie” video is acquired by the device camera while operating within its “ … designed function”
The device camera is NOT used by our tech as a sensor for providing a health measurement - such as performing PPG sensing by placing your finger entirely over the camera lens. This is NOT what we are doing
Additional Details for AHI FaceScan SDK:
Only if requested by the review team …. then you should explain that:
- The SDK converts the 30-second “selfie” video into highly compressed binary payloads (blobs)
- These compressed payloads are securely transmitted by the app (off device) to a remote cloud service where they are individually processed by computational models
- The results of the processed payloads are returned by our API to the app for display and/or storage only
AHI has a list of suggested risk categories for the output provided by FaceScan. These categorizations are based on published research and/or international health guidelines.
Clients and partners do not have to follow these examples and are recommended to utilize guidelines that are best suited for the populations they are serving.
Risk categories for:
Vital signs
Health indicators
Health risk predictions
AHI has a list of suggested risk categories for the output provided by BodyScan. These categorizations are based on published research and/or international health guidelines.
Clients and partners do not have to follow these examples and are recommended to utilize guidelines that are best suited for the populations they are serving.
Risk categories for:
The latest version of MultiScan SDK is "23.11"
Steps to upgrade
- Follow install instructions to get the latest version – Key points to note below:
Android distribution - Define new SDK version when adding Maven repo
iOS distribution - Simply install the latest version using CocoaPods or Swift Package Manager. - Replace any other instances of the old version number (e.g. “21.1”) in your code with the latest version number
- Fix any compilation issues that arise
- Test to check that the scans can be completed and are returning outputs correctly
- Ensure that the SDK output shows the version you have updated to
An example of the code changes applied in an upgrade is shown on GitHub (shows v23.9 to v23.10 upgrade).
Estimated time required: 1 day of work + QA
May vary depending on developers' familiarity with the SDK
Relevant links:
Quick Start Guide for the full MultiScan SDK integration process.
Key Points to Note
- We strongly suggest that short form disclaimers are shown on every measurement results screen
- Optionally, you can attach a hyperlink to a long form disclaimer to provide more details
- A separate disclaimer screen may be presented during the user onboarding process
- Please review the additional guidelines for blood pressure measurement
Short Form Disclaimer
For investigational use only
[Your app / FaceScan feature name] is not designed for medical diagnosis or to evaluate medical conditions and is not a substitute for the clinical judgement of a health care professional. [Your app / FaceScan feature name] does not diagnose, treat, mitigate, monitor or prevent any disease, symptom, disorder or abnormal physical state. You should always consult a trusted health professional before making decisions about your health.
Expected Fluctuations in Readings
Moment-to-moment fluctuations in your physiology mean that readings could vary to some degree from one measurement to the next. The best estimate of your readings is therefore obtained by averaging several measurements throughout the day and across several days to adequately account for this physiological variation.
Long Form Disclaimer
Optional long form medical disclaimer to be hyperlinked in the web page behind the short form disclaimer.
Not for Medical Purposes
OUR SERVICES ARE NOT INTENDED FOR MEDICAL PURPOSES. THE SERVICES DO NOT OFFER ANY KIND OF MEDICAL ADVICE AND ARE NOT INTENDED FOR ANY MEDICAL USE OR PURPOSES. OUR SERVICES ARE INTENDED FOR GENERAL WELLNESS ONLY.
THE ESTIMATIVE MEASUREMENTS (“MEASUREMENTS”) PROVIDED TO YOU OF PHYSIOLOGICAL AND PSYCHOLOGICAL STATES INCLUDING HEART RATE AND BLOOD PRESSURE SHOULD NOT BE TREATED AS MEDICAL ADVICE. THE MEASUREMENTS WE PROVIDE TO YOU ARE NOT INTENDED TO BE UTILIZED FOR ANY MEDICAL PURPOSES OR TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE, AILMENT OR INJURY. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, YOU EXPRESSLY AGREE WE ARE NOT PROVIDING ANY MEDICAL ADVICE VIA OUR SERVICES. ALL CONTENT PROVIDED BY OUR SERVICES INCLUDING THE MEASUREMENTS IS NOT INTENDED TO BE AND SHOULD NOT BE USED IN PLACE OF (A) THE ADVICE OF YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS, AND (B) A VISIT, CALL OR CONSULTATION WITH YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS. SHOULD YOU HAVE ANY HEALTH-RELATED QUESTIONS, PLEASE CALL OR SEE YOUR PHYSICIAN OR OTHER HEALTHCARE PROVIDER PROMPTLY. IF YOU HAVE AN EMERGENCY, CALL YOUR PHYSICIAN OR YOUR LOCAL EMERGENCY SERVICES IMMEDIATELY. YOUR USE OF OUR SERVICES DOES NOT CONSTITUTE OR CREATE A DOCTOR-PATIENT, THERAPIST PATIENT OR OTHER HEALTHCARE PROFESSIONAL RELATIONSHIP BETWEEN [Brand/Business Name] AND YOU
Accuracy
THE MEASUREMENTS PROVIDED TO YOU ARE BASED ON INDICATORS AND STANDARDS DEVELOPED BY [Brand/Business Name] ITSELF AND ARE ONLY FOR PERSONAL INFORMATION PURPOSES, WITHOUT ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED. WHILE WE MAKE EVERY EFFORT TO PROVIDE ACCURATE ESTIMATIVE MEASURES, WE MAKE NO WARRANTY AND DISCLAIM ALL RESPONSIBILITY AND LIABILITY FOR ANY ACCURACY, RELIABILITY, AVAILABILITY, SECURITY, COMPLETENESS OR CORRECT USE OF MEASUREMENTS, CONTENT AND ANY OTHER INFORMATION OR RESULTS YOU RECEIVE THROUGH THE SERVICES.
Additional Guidelines for Blood Pressure Measurement
Blood pressure is a highly volatile reading as it is easily affected by a variety of environmental factors such as whether a person has been recently active or is resting in the wrong position. It is important to take this into account when displaying results and when guiding users to take a scan. Doing so will help to provide more accurate representations of their health.
Suggested Methods to Display Blood Pressure Results
- Consider using terms like “Estimated blood pressure” to show that you are providing approximations.
- Consider displaying the risk categories or number ranges in place of exact blood pressure numbers.
- You can categorize results as 'Hypertension' and 'Hypotension' risks, shifting user focus from fluctuating numbers to understanding associated risks.
- Consider assessing blood pressure related risks/ranges based on an average of multiple scans (2-3 scans as described in next section) rather than a single reading.
Tips to improve accuracy of blood pressure measurement for users
- Avoid exercise, consuming caffeine or smoking 30mins before measurement
- Rest for at least 5 minutes prior
- Sit in a chair with back supported
- Place both feet on the floor, legs should not be crossed
- Measure blood pressure twice with 1 minute break in between. If the readings vary by 5 points or more, do a third measurement. Use the average of the readings.
- If consistently high readings persist, it's essential to see a healthcare professional. They can provide guidance, perform further evaluations, and, if necessary, recommend treatment.
References:
NIH National Library of Medicine - Blood Pressure Measurement
Harvard Health Publishing - Tips to measure your blood pressure correctly
SDK initialization issues
- Check if your token works by running the example code with your development token
- Check your token expiry on LastPass where token details have been shared
User authorisation issues
- Ensure User ID, salt and claims(optional) have been applied correctly. Learn how.
- Ensure User ID, salt and claims are consistent each time the same user is authorised
Cannot start Face or Body Scan
- First, check if setupMultiScanSDK() was called successfully
- Second, check if authorizeUser() was called successfully
- Third, check that areResourcesDownloaded() is true (resource have been downloaded entirely) - Resources applicable for BodyScan only
- Ensure input schema is followed correctly
- Ensure input values are within accepted ranges
SDK output issues
- Check if SDK output schema is followed correctly
- Check if values from JSON output are mapped and converted correctly
Scan credit error
- Ensure the correct user ID has been announced to ScanControl API prior to doing the scan
- Ensure a valid ScanControl product ID is used when calling the API
- If using DEV token, 'env:SANDBOX' should be called on the ScanControl API
- If using PROD token, 'env:PRODUCTION' should be called on the ScanControl API
Scan process instability
- Please check network speed or try switching to a different network
Error running release build from Android Studio or CLI
- There is a security mechanism that we have in place that prevents the use of debuggers in release mode. You should build the APK and install it directly on the device for testing
AHI QA Process Steps
When a client has completed the technical integration, the QA process should be initiated as follows:
- Client requests for QA booking
- AHI to hand QA checklist to client and simultaneously arrange an upcoming timeslot with internal QA
- Client to do QA of the integration against the checklist to ensure all items pass
- Client to handover app access to AHI for us to conduct second round QA
- AHI to perform QA of the integration based on the same checklist items
- We commit to completing the QA process within 10 working days (excludes time taken for additional fixes)
- The goal is to ensure that SDK is integrated well with no errors through the initiation, scanning, and results output processes.
- This is not a QA of the clients' application. However, we can provide feedback for any notable flaws we encounter outside of the SDK.
- Sign-off on QA, share Prod tokens and prepare for launch
AHI QA Checklist
General Checklist
- If user input data is taken from elsewhere (e.g. profile section), they should be mapped correctly to the SDK input schema
- Subscription packages or one-off scan purchases are linked to the correct ScanControl Product ID
BodyScan Checklist
- Remote assets for BodyScan download as expected
- Weight bounds checking has been verified - within 16-300kg or 36-660lb or equivalent.
- Height bounds checking has been verified - within 50-255cm or 1'8"-8'4" or equivalent
- BMI bounds checking has been verified - BMI between 10-60
- Age bounds checking has been verified - at least 15 years old
- SDK output data are mapped correctly to the metrics displayed
- Results that require calculations are calculated correctly
- 3D Model displaying correctly (optional feature)
- Can complete BodyScan capture
FaceScan Checklist
- Weight bounds checking has been verified - 30-300kg or 67-660lb or equivalent
- Height bounds checking has been verified - within 120-220cm or 4'0"-7'2" or equivalent
- BMI bounds checking has been verified - BMI between 10-65
- Age bounds checking has been verified - 13-120 years old
- SDK output data are mapped correctly to the metrics displayed
- Results that require calculations are calculated correctly
- Can complete FaceScan capture
Note: if the client is using both BodyScan and FaceScan and pulls height/weight info from user profile, the bounds should be validated so that it falls WITHIN the upper and lower bounds of both scans (using the smaller upper and lower numbers)
The AHI Developer Documents outline the technical specifics and integration code of the AHI offerings. This section of the AHI document is geared towards software developers rather than designers or marketers of a company.
AHI Cloud
AHI Cloud provides mechanisms to support AHI technologies, including such features as:
- Remote files hosting to offload some of the SDK content to help reduce the SDK install size.
- User authorization (authZ), not to be confused with user authentication, which helps control rate limits.
- Billing service for the SDK to submit billing events to for AHI to track and create invoices.
- "Scan Control" user scan credit solution, where user must first be in credit to do a scan (if enabled).
MultiScan SDK
AHI MultiScan SDK is designed to help simplify the integration work for potentially many different scan technologies into an App project. MultiScan SDK accomplishes this by abstracting the specific scanner details to all be within a single abstraction layer / interface, which can be summarized as:
- setup() Initialization aspects of the AHI solution.
- userAuthorization() Provide user access to AHI services (not to be confused with user authentication).
- initiateScan() Initiate the scan process.
MultiScan SDK is the umbrella project to which an App integrates the AHI scan technologies, such as:
BodyScan
Scan technology where a front and side capture of a user's body is used to determine body circumference and body composition measurements.
FaceScan
Scan technology where a recording of a user's face is used to determine vital signs, cardiovascular health indicators, and health risks.
Quality Assurance
Quality of the products AHI provide is of utmost importance. AHI continue to strive to make sure the products released meet our high threshold of reliability, performance, and resilience. Likewise, AHI look to help verify that scan technology is being used properly and to the greatest benefit for the client integration.
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