BioIntelliSense BioMobile Application Sync Data From Their Medical Grade Instructions

BioIntelliSense BioMobile Application Sync Data From Their Medical Grade

Indications for Use

• The BioMobile application is intended for the user to sync data from their medical-grade BioIntelliSense wearable devices.
• The BioMobile application may include in-app data visualization and/or in-app surveys based on the specifications of the monitoring program.
• The BioMobile application is indicated for use by users who are 18 years of age or older.

WARNING: The BioMobile application is NOT intended to be used by users who need urgen or intensive care.

CAUTION: The BioMobile application does NOT treat, diagnose, or prevent any disease or conditions.

READ through the Instructions for Use before using the application.

Home screen and the paired device may vary based on the specifications of the monitoring program.

IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY
Our support line is not for medical emergencies. If you believe you have an emergency, call 911.
For non-urgent support or questions about our product, please call 888.908.8804 (US ONLY) or email support@biointellisense.com

Downloading the App

MINIMUM SOFTWARE REQUIREMENTS

DOWNLOAD INSTRUCTIONS
To download the app to your mobile device:

• SCAN the QR code to the right,
• VISIT BioIntelliSense.com/biomobile, or
• SEARCH for “BioMobile” in the Google Play or Apple App Store

Registration and Account Creation

ENTER YOUR REGISTRATION CODE
The registration code is a 6-character code that may have been provided to you via email or quick start guide from your program administrator.
If you can’t locate your registration code, please contact customer support.
The Registration code is 6 characters long. It is NOT the 10-digit Bio ID that is located on your packaging.
Tap CONTINUE to submit your registration code.

CONFIRM ORGANIZATION
Tap YES to confirm your organization.

ACCEPT TERMS AND CONDITIONS

SCROLL DOWN to read the full text.
Select the CHECK BOX to accept the Terms and Conditions. Tap ACCEPT.

ALLOW BIOMOBILE TO USE BLUETOOTH (iOS)
BioMobile requires the use of your iPhone’s Bluetooth Setting to connect with your BioIntelliSense BioSticker™ or BioButton® device to sync data and to receive periodic software updates.
Tap OK to allow.

ALLOW BIOMOBILE TO USE LOCATION (iOS/ANDROID)
iOS: BioMobile will request Location Permissions to improve background performance and data collection.
ANDROID 11 and below: BioMobile requires the use of your Location with Bluetooth to continuously find and connect to your wearable devices even when the app is closed or in the background.

NOTE: Your location data is not stored or shared.

CREATE AN ACCOUNT OR LOG IN
Tap LAUNCH LOGIN PORTAL to launch the secure account creation and login portal.

CREATE AN ACCOUNT (SIGN UP)

For first time use:

ENTER a valid email address in the first email field and re-enter it in the second field to confirm.

ENTER a valid password in the first password field and re-enter it in the second field to confirm.

Please check with your program administrator if you must use an email address that is associated with your organization i.e. personal or work email.

Tap SIGN UP at the bottom of the screen to create your account.

LOG IN TO AN EXISTING ACCOUNT
If you previously created an account, tap LOG IN and enter the email address and password you used to create your account.

REMINDER: You may have used an email address that is associated with your organization i.e. personal or work email.
If you need to reset your password, please tap Don’t remember your password? and enter the email address associated with your account. You will receive an email with password reset instructions.
If you forgot your email, please contact customer support.

ENTER YOUR TIMEZONE

Tap CONTINUE to confirm that the timezone shown is correct.

• Tap Choose Another Timezone to select a different timezone from the one shown.

ENTER YOUR INFORMATION

ENTER your information* and tap NEXT until you have completed all the fields.
Tap CONTINUE after all fields have been completed.
NOTE: Personal information is shared and protected per BioIntelliSense’s Terms of Use and Privacy Policy. The type and amount of information requested may vary based on the specifications of the program. Contact your program administrator or customer support if you have any questions or concerns.

Pairing Your Device

SELECT YOUR DEVICE
Tap SELECT to continue.

POWER ON YOUR DEVICE
Follow the instructions to power on your device.
Tap I SEE THE BLINKING LIGHT to continue.
IFU-BMO-1072 Ver. 1

ENTER THE 10-DIGIT BIO ID
The Bio ID is 10-digits and is located on the outer package, the instruction manual, and the device.
Press PAIR DEVICE to continue.

NOTE: The Bio ID is NOT the FCC ID, REF Number or Product Code on the front of the packaging.
BioButton Rechargeable users: Fully charge your device before completing this step.

DEVICE SOFTWARE UPDATE

The device may perform a software update. Please follow the on-screen instructions to:

• Press device’s button and confirm device light blinks
• Place the device on or near your phone
• Keep the app open. Do not close or leave the app until pairing is complete.

Please keep the app open and DO NOT close the app or disconnect the device while the update is in progress.

If the software update fails, try one or both of the following:

• Tap RETRY to restart the software update
• Quit the app (swipe close) and restart this process.

If this issue persists, please contact customer support.

INSTRUCTIONAL SLIDES

Proceed through the instructional slides to get acquainted with your device and the BioMobile app.

SET UP COMPLETE!
After the instructional slides, you will land on the dashboard.
The app will scan and sync the data from your paired device.

NOTE: On the home screen you may choose to allow app notifications to improve your monitoring experience.

Using the App

The dashboard will display up to five (5) main components.

• My Device Tile
• Helpful Tips
• My Data / BioReport*
• Monitoring Progress
• Menu

The My Data / BioReport tile may look slightly different or may not be present depending on your program settings.

MY DEVICE TILE
The My Device tile will show you information about your device:

• The Bio ID is displayed in the upper right corner
• The tile will show the current state of the device including: last sync, sync progress, and software update progress.

The Last Sync should be no more than 1 hour ago if your device is connected and the app is running.
If you receive a notification saying that the App has not received data for 4 or more hours, launch the App. The App will begin scanning for your device and once found, will begin to sync.
NOTE: There are no user actions to perform a sync.
If you are experiencing issues with syncing please see the “Troubleshooting” section.

HELPFUL TIPS
Slide the tips tiles to the left to learn more about the app and your monitoring experience.

MY DATA TILE
Depending on your monitoring program, you may be able to view your data in the app.

• The MY DATA tile will show your data in trending charts.
• The BIOREPORTS tile will display all of your BioReports generated from the beginning of your monitoring period.

VIEW BIOREPORTS

View, share, and print all BioReport PDF files that have been generated from the beginning of your monitoring period.

MONITORING PROGRESS TILE

• See how many days are left in your monitoring period.
• Learn more about your monitoring period and what happens after it concludes.

MENU
To open the menu, tap the three dots in the upper right corner.
You will see the following options:

• Your Privacy
• Settings
• Replace My Device: In the event you need to replace your device, select this menu option. See “Device Replacement” below for details.
  • NOTE: This option should NOT be used if you have recently completed first-time registration and paired your device.
• Support: If you have questions about the app or need support, select this menu option. See “Contact Support” below for details.
• Log Out

DEVICE REPLACEMENT
If your device was lost or damaged and you received a new device, you can replace your device in the BioMobile app.

From the menu, select REPLACE MY DEVICE.

Proceed only if you have a working replacement device that has never been set up before.

Check the box and tap CONTINUE. Make sure you have:

• Reliable Bluetooth and network connectivity
• Five to fifteen minutes of time

If you have these, please tap PROCEED. If you do not, please tap SET UP LATER.

WARNING: If you proceed without a device, you will need to uninstall and reinstall to go back to the dashboard.

SELECT the new replacement device.
Continue through the screens and pair your new device with your account.
When this step is complete, you will return to the dashboard and your new device’s Bio ID will be visible on the My Device Tile.

CONTACT SUPPORT
If you have questions about the app or need support, you can contact our support team from the app.
From the menu, select CONTACT SUPPORT.
On the Contact Support screen, select your concern using the drop down and provide any details regarding the issue you are encountering.

Select CREATE EMAIL and an email will be drafted with your message, account information, and app logs which will help our team investigate.
NOTE: For other questions related to your program, please contact your program administrator.

Troubleshooting and FAQs

WHERE IS MY BIO ID LOCATED?

• The 10-digit Bio ID is located on the device, the device packaging and on the Instructions for Use.
• Once registered, your Bio ID is displayed in the My Device section of the BioMobile home screen.

HOW OFTEN SHOULD MY DEVICE SYNC?

• The device will sync with the BioMobile application every 10-30 minutes when the BioMobile application is running, either in the foreground or background.
  • NOTE: For iPhone (iOS) users, the BioMobile app must be open and in the foreground for device data to sync.
• The My Device section of the BioMobile displays the time of last sync.
• If you encounter difficulty syncing, please follow the instructions noted below:
  • Restart the app to initiate a scan for the device. This will not force a sync unless 10-30 minutes or more has elapsed since the last sync time.
  • DO NOT quit the application when syncing is in progress.

MY DEVICE IS NOT SYNCING, WHAT SHOULD I DO?

• Press and release the device’s button and confirm that the device blinks green. If you do not see the LED light blink green, please contact BioIntelliSense Support.
• Check your mobile device settings and ensure that Bluetooth is turned on.
• Quit and restart the application.
• If you are still unable to sync, log out of the BioMobile app and log back in (to access this menu, press the three vertical dots on the top right of the home screen).
• If you require additional support, please contact support@biointellisense.com or call 1.888.908.8804 (US Only).

Safety and Regulatory Information

TERMS OF USE STATEMENT
Use of the BioIntelliSense Product(s) is subject to our:

• Website and Product User Terms of Use (BioIntelliSense.com/legal/website-and-product-user-terms-of-use)
• Website and Product Privacy Policy (BioIntelliSense.com/ legal/privacy-policy)

By using the Product(s), you indicate you have read these terms and policies and that you agree to them, including the limitations and disclaimers of liability. In particular, you understand and consent that use of the Product(s) measures and records personal information about you, including vital sign and other physiologic measurements. That information may include respiratory rate, heart rate, temperature, activity level, sleep duration, body position, step count, gait analysis, coughing, and other symptomatic or biometric data. You understand that the Product(s) do not render medical advice or diagnose or prevent any specific disease, including any communicable disease or virus. If you have any concerns about your health, including whether you have been exposed to or have contracted any disease or virus, immediately contact your healthcare provider.

REGULATORY STATEMENT
Expanded Indications for Use Under FDA Enforcement Policies during the COVID-19 Public Health Emergency – The indications for use of this device that have expanded under FDA Enforcement Policies during the COVID-19 Public Health Emergency are:

• Updating software of the wearable sensor devices via the BioMobile application
• The device does not require physician prescription due to the Over-the-Counter (OTC) designation

Recommendations provided by the device are adjunctive (supporting) and should not be solely or primarily relied upon to prevent, diagnose, or treat COVID-19 or co-existing conditions.
BioIntelliSense, BioButton, and BioSticker are trademarks or registered trademarks of BioIntelliSense, Inc.

Contact Us
For non-urgent support or questions about our product, please call 888.908.8804 (US Only) or email support@biointellisense.com
MANUFACTURED BY
BioIntelliSense, Inc.
570 El Camino Real #200
Redwood City, CA 94063
IFU-BMO-1072 Ver. 1

References

• BioIntelliSense
• BioIntelliSense
• BioIntelliSense

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