Page 1 ™ ™ SYSTEM USER GUIDE...
Page 3 ™ connected devices for people who use disposable insulin pens for their diabetes care. With Bigfoot Unity you get a set of connected devices to: • Monitor your glucose continuously and give you readings on demand without fingersticks. • Do the math for you to determine the correction and meal doses recommended by your health care provider.
Page 4: Table Of Contents
User Guide, the App and Cap Displays Symbols that Appear in this User Guide, the App and Cap Displays Help and Support (Customer Care) 2 Before You Begin Using Bigfoot Unity Overview The Bigfoot Unity App The Black Cap for Long-Acting Insulin...
Page 5 Bigfoot Unity Welcome Kit Package Contents Compatible Insulin Pens Compatible Insulin Pen Needles Compatible Mobile Phones and iOS 5 First Time Setup of Bigfoot Unity Getting Ready to Set Up Bigfoot Unity Download the App and Create an Account Enter Settings...
Page 6 6 Using Bigfoot Unity Caps Pairing the Black and White Caps Using the Black and White Caps Viewing Time Since Last Long-Acting Dose on the Black Cap Viewing Long-Acting Dose Amount on the Black Cap Viewing Time Since Last Rapid-Acting Dose on the...
Page 7 MY SETTINGS Insulin Settings Alerts Very Low Glucose Alert Low Glucose Alert Sensor Unavailable Alert Long-Acting Dose Alert App PIN My Data Supplies Learn to Use Bigfoot Unity Help and Support About The Bigfoot Unity Diabetes Management System User Guide ™...
Page 8 9 Care, Maintenance and Disposal of Bigfoot Unity Living with your Bigfoot Unity Diabetes ™ Management System Cleaning Cleaning the Outside of the Cap Cleaning the Inside of the Cap Cleaning and Disinfecting Your Meter Pen Needles Insulin Pens Disposal 10 Troubleshooting 10.1...
Page 9 Appendix B: Settings for Bigfoot Unity App B.1 Information to Enter in the App Long-Acting Insulin Rapid-Acting Insulin Notes Appendix C: Technical Information C.1 Labeling Symbols C.2 Sensor Specifications C.3 Cap Specifications C.4 Communications Specifications C.5 Bigfoot Unity™ Diabetes Management System Specifications C.6 Kit Specifications...
Page 10: Tips For Reading And Understanding This User Guide
™ System for your diabetes care, you will need to complete tutorials in the App on how to set up Bigfoot Unity and use the App, Caps, Sensor and Meter. Information about viewing this User Guide online can be accessed in the App under MY SETTINGS –> Help and Support.
Page 11: Symbols That Appear In This User Guide, The App And Cap Displays
Contact Bigfoot Customer Care using any of the following: Phone: (551) BIGFOOT or 244-3668 (888) 523-3662 Web: support.bigfootbiomedical.com Tap Help and Support on the My Settings screen to access this User Guide and contact Customer Care. The Bigfoot Unity Diabetes Management System User Guide | Chapter 1 ™...
Page 12: Before You Begin Using Bigfoot Unity
This User Guide describes how Bigfoot Unity works, important safety information, how you set up and use Bigfoot Unity, and what to do if you need help. Bigfoot Unity is available only with a prescription in the U.S.
Page 13: The Black Cap For Long-Acting Insulin
The White Cap can also receive glucose results from the connected blood glucose Meter. The connected devices of Bigfoot Unity allow for easy transfer of data between the White Cap, the Sensor, the blood glucose Meter, and the App. On the App Home screen only your glucose range will be displayed.
Page 14: Monitoring Glucose With The Sensor
White Cap at least every 8 hours to avoid any gaps in Sensor glucose data. 2.5 Monitoring Glucose with the Sensor Bigfoot Unity uses the Sensor to measure your glucose in the interstitial fluid just below the skin surface. Sensor readings are displayed on your White Cap.
Page 15: About Cloud Services And Wireless Communication
WiFi connection to set up the System, and it must connect to the internet periodically to back up data to the cloud. After Bigfoot Unity has been set up, daily activities can be done without internet service. Cloud-based services let your health care provider have access to your data.
Page 16: Indications And Safety Information
Bigfoot Unity As with any medical device, there are benefits and risks associated with the use of Bigfoot Unity. Pay attention to safety information, especially Warnings and Cautions associated with its use. Always consult with your health care provider if you have questions regarding the best way to maximize the benefits and minimize the risks of using Bigfoot Unity.
Page 17: Risks
Risks There are risks associated with using Bigfoot Unity. Some of these are inherent in using Bigfoot Unity and others are related to making decisions about managing your diabetes. • There is always the risk of dosing too much or too little insulin.
Page 18: Contraindications
• Bigfoot Unity is intended to be used after you have consulted with your health care provider so that the insulin and glucose information entered in the App is right for you. You should check carefully to make sure the information you enter is correct. Always consult with your health care provider before you begin using Bigfoot Unity and for the information you are required to enter in the App.
Page 19: Who Should Not Use Bigfoot Unity
Bigfoot Unity components and supplies. • Bigfoot Unity must not be used by more than one person due to the risk of providing incorrect glucose and insulin information.
Page 20: Cap And App Usage
• Consult with your health care provider to make sure you have a backup diabetes management plan and diabetes supplies if parts of Bigfoot Unity are lost or stop working. Having a backup plan and supplies can help avoid severe high or low glucose if you cannot use Bigfoot Unity.
Page 21 • Place the Bigfoot Unity Cap back onto the insulin pen immediately after taking an insulin dose. If you do not replace the Cap promptly, the time since last dose may not be accurate. This may result in you taking too much or too little insulin, which can lead to severe low or high glucose.
Page 22 Your App will indicate if Bluetooth is not turned on. You can only use the App for 4 hours after Bluetooth is turned off. • You must allow Critical Alerts for the Bigfoot Unity App to receive Bigfoot Unity Alerts, including the Very Low Glucose Alert, even when your phone is muted or set to “Do Not Disturb.”...
Page 23: Sensor Glucose
• Always keep your phone on and charged with the Bigfoot Unity App open (do not force close), and keep your phone nearby (within 20 feet). This will help you receive and hear Notifications and Alerts, which may prevent severe low or high glucose.
Page 24 Applicator appear to be damaged or already opened due to risk of no results and/or infection. • Do NOT use if Sensor Kit contents are past expiration date. The Bigfoot Unity Diabetes Management System User Guide | Chapter 3 ™...
Page 25 Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising. The Bigfoot Unity Diabetes Management System User Guide | Chapter 3 ™...
Page 26: Interfering Substances
What to Know about X-Rays • The Sensor should be removed prior to exposing it to an X-ray machine. The effect of X-rays on the performance of Bigfoot Unity has not been evaluated. The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period.
Page 27: Bigfoot Unity Welcome Kit
Bigfoot Unity Welcome Kit 4.1 Working with Your Health Care Provider To get started using the Bigfoot Unity Diabetes Management ™ System, you and your health care provider will work together to decide the information that makes up your personal insulin settings.
Page 28: Compatible Insulin Pens
Contact Bigfoot Customer Care at (551) 244-3668 if any items are missing or appear to be damaged or already opened. Maintain Secure Control of your Bigfoot Unity Components. Maintain secure custody of Bigfoot Unity components and supplies to avoid unauthorized access or tampering. 4.3 Compatible Insulin Pens...
Page 29: Compatible Insulin Pen Needles
4.4 Compatible Insulin Pen Needles The Bigfoot Needles that come with Bigfoot Unity are designed to fit your insulin pens. You can choose to use any other needles that fit on your insulin pens. Consult with your health care provider about what is the best needle for you.
Page 30: First Time Setup Of Bigfoot Unity
Bigfoot Unity, including your Sensor, Meter and USB Charger. The App includes a series of short tutorials and instructional videos to help you learn how to use Bigfoot Unity. These screens display a play button ( ) to proceed. Before you can proceed to the next section during setup, you must complete the current section.
Page 31: Enter Settings
3. Download and install the Bigfoot Unity App from the App Store. After the installation completes, make sure the App icon appears on the phone screen. 4. Launch the App on your phone. 5. Login to your account with your email address and password.
Page 32: Enter Insulin Settings
3. Select your long-acting insulin by tapping on the insulin you use. 4. Enter the daily insulin dose (1 to 160 units) for your long-acting insulin using the pop-up numeric keypad. Tap Done when finished and Next to continue. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 33: Entering Rapid-Acting Insulin Settings
No, I Don’t Take Mealtime Insulin to skip this section. Bigfoot Unity offers three options for how to display Mealtime Insulin on your White Cap for rapid-acting insulin when it’s time to dose. Only one option can be used at any given time, but you can switch between options anytime.
Page 34 Done when you are finished. • Repeat for your second and third meal sizes. • Tap Next when you are finished. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 35 (of carbohydrate) amount and tap Done when you are finished. • Repeat for your two other Carb Amounts. • Tap Next when you are finished. Example: Carb Amounts and unit selection The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 36 No, I Don’t Take Correction Insulin to skip this section. Bigfoot Unity offers two options for how to enter your glucose ranges and correction units. Only one option can be used at any given time, but you can switch between options anytime as needed.
Page 37 Correction Table at any time. Enter/Modify Your Ranges 1. If you want to make changes to your ranges, first tap Edit at the top right. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 38 3. Repeat Step 2 to change the lower or upper limits on any other range. 4. When you are finished editing ranges, tap Save. Example: Custom glucose ranges The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 39 Note: If you tap Edit, you will be prompted to confirm that any previously entered insulin amounts will be cleared. Tap OK to continue. 3. Once you are finished entering/editing units, tap Next. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 40 2. Enter your Correction Factor (10 to 250 mg/dL), then tap Done. Your Correction Factor is how much one unit of rapid-acting insulin lowers your glucose. Example: Glucose Target of 120 mg/dL The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 41: Entering Notes
• If you do not want to enter any Notes, tap Skip to skip this section. • Notes have a limit of 1000 characters and 3 images. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 42 Note: If this is your first time setting up your App, two pop-up messages will appear asking if Bigfoot Unity can access your camera and photos. Tap Allow to allow. Access can be changed in your phone settings.
Page 43: Review Insulin Settings
Note: If you make any changes, tap Next to return to the Review and Confirm Rapid-Acting Insulin screen. Then tap Confirm to continue with the next step. Example: Rapid-acting insulin and doses The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 44: Set Phone Notifications
3. Tap Allow to allow Notifications on your phone. WARNING: You must allow Notifications for the Bigfoot Unity App to receive Bigfoot Unity Alerts on your phone when you are not actively viewing the App. Do NOT turn off Notifications. If you do not allow alert Notifications,...
Page 45 Critical Alerts or Bluetooth are turned off in your phone settings, you will be notified that you must set your phone settings properly in order to continue to use the Bigfoot Unity App. See the following page for Bigfoot’s recommended phone settings.
Page 46: Recommended Phone Settings
App to work. If your phone is off, you will not get any alerts. You should also keep the App open at all times and not force it to close by swiping it off the screen. The Bigfoot Unity App must be open for Bigfoot Unity to work properly and for you to get alerts.
Page 47: Set Up Devices
Your phone has a Screen Time feature with settings for Downtime and App Limits. Both of these settings can temporarily block the Bigfoot Unity App from working. If you set time limits for the Bigfoot Unity App, you cannot open the App or get alerts. Either: •...
Page 48: Start Black Cap
1. Tap Set Up Devices. 2. Tap Allow when prompted to turn your phone’s Bluetooth setting on to allow communication with the other Bigfoot Unity devices. Start Black Cap You will need your Black Cap and your long-acting insulin pen for this section. Your Black Cap is used to replace the cap on your long-acting insulin pen.
Page 49 App for pairing. The App will automatically search for and display the Serial Numbers of any Black Caps it finds within range. App Display Black Cap Display The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 50 Black Cap. Contact Bigfoot Care at (551) 244-3668 and your health care provider (as it may require a new prescription) to obtain the correct Black Cap. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 51: Start White Cap
3. Review your rapid-acting insulin information. You may need to swipe up (scroll) to view all the entries. • Tap Confirm to continue. • Tap Edit to make changes. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 52 The App will begin to pair with the selected White Cap. Once the pairing is complete, the App and Cap will indicate that pairing was successful and the App will send your rapid-acting insulin information to the White Cap. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 53 Then tap Next. The Set Up Devices screen will be displayed. A check mark ( ) will indicate that the Start White Cap section is complete. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 54: Start Meter
Biomedical. 1. Tap Start Meter. 2. Tap Next. IMPORTANT: Use the Meter that is paired with Bigfoot Unity when checking blood glucose. If you use a different meter, blood glucose values will not display on the White Cap. 3. Press and hold the button on your Meter until you see the Bluetooth icon ( appear on the display and then tap Next.
Page 55 White Cap, wait for the Meter’s screen to turn off, and try again. 5. Confirm that the code displayed in the App matches the code displayed on the Meter you intend to use. App Display Meter Display The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 56 App Display Meter Display 6. Tap OK. The Set Up Devices screen will be displayed. A check mark ( ) will indicate that the Start Meter section is complete. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 57: Start Sensor
Sensor. • Tap Next if you want to skip these screens. • Tap Step-by-Step Instructions if you want the informational screens displayed. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 58 Libre 2 sensor beyond start-up. Scanning the Sensor with the phone will not collect or display current glucose data. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 59 • Read Important message that taking more than 500 mg of Vitamin C supplements per day can falsely raise Sensor readings, and then tap I Understand to continue. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 60 • You will go back to the Set Up Devices screen, with all devices having a check mark. Tap Done to proceed. The Next Up, Learn to Use Bigfoot Unity screen will be displayed. A check mark ( ) will indicate that the Set Up Devices section is complete.
Page 61: Learn To Use Bigfoot Unity
The last App Setup section walks you through a series of short video clips, reviews screens, knowledge checks and final reminders intended to help you become more familiar with Bigfoot Unity. 1. Tap Learn to Use Bigfoot Unity. 2. Read the Important pop-up message and tap OK.
Page 62: Monitoring Glucose
Monitoring Glucose 9:41 This section will review how to monitor your Back glucose with Bigfoot Unity. Learn to Use Bigfoot Unity 1. Tap Monitoring Glucose. In this section, you will learn about: Monitoring Glucose Using the White Cap for <Insulin>...
Page 63 7. After tapping Next on the last Knowledge Check screen, the Learn to Use Bigfoot Unity screen will be displayed. A check mark ( ) will indicate that the Monitoring Glucose section is complete. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 64: Using The White Cap For Rapid-Acting Insulin
4. Tap Next at the bottom of each screen to continue to the next one. After tapping Next on the last Knowledge Review screen, you will be prompted to check your knowledge. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 65: Using The Black Cap For Long-Acting Insulin
White Cap section is complete. Using the Black Cap for Long-Acting Insulin This section will review how to use your Black Cap. 1. Tap Using the Black Cap. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 66 Check screen, the Learn to Use Bigfoot Unity screen will be displayed. A check mark ( ) will indicate that the Using the Black Cap section is complete. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 67: Important Reminders
Important Reminders 1. Tap Important Reminders. This section provides a final review of important reminders about Bigfoot Unity. • Read each of the reminder screens carefully and tap I Understand at the bottom of each screen to continue to the next one.
Page 68 4. After tapping Next on the last practice screen, Customer Care information will be displayed. • Tap Done. Congratulations on completing the App Setup. The Bigfoot Unity Diabetes Management System User Guide | Chapter 5 ™...
Page 69: Using Bigfoot Unity Caps
Using Bigfoot Unity Caps Your Caps are used to help you keep track of how long it’s been since you injected your last insulin dose using the pen. The White Cap also captures glucose data from your Meter and Sensor and sends the data to the App.
Page 70 Remember that the Black Cap is always used with your long-acting insulin pen, and the White Cap with your rapid-acting insulin pen. The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 71 Every time you remove the Cap for 4 or more seconds and place the Cap back on the pen, Bigfoot Unity thinks you took a dose of insulin and re-starts counting the “time since last dose.”...
Page 72: Viewing Time Since Last Long-Acting Dose On The Black Cap
Black Cap button again to display the Daily Dose of long-acting insulin that Example: Daily Dose on Black Cap screen you and your health care provider have entered in the App. The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 73 • Bigfoot Unity only records doses taken with the insulin pens you use with the Caps. If you take a dose of insulin without using Bigfoot Unity, make sure you keep track of the time you took insulin and check your glucose frequently.
Page 74: Viewing Time Since Last Rapid-Acting Dose On The White Cap
Sensor glucose readings for making treatment decisions. Note: Bigfoot Unity will only use a glucose result taken from the Meter or Sensor to display a Correction Insulin dose on your Cap if the glucose value was recorded within the last 10 minutes.
Page 75: Scanning The Sensor With The White Cap
• Your Sensor glucose level will appear on the White Cap along with a Glucose Trend Arrow indicating the direction your glucose is going. Example: Example: Sensor glucose reading Sensor glucose reading The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 76: Understanding Glucose Trend Arrows And Glucose Messages
• There are other situations where your Sensor is not able to provide glucose readings or there is a problem with the Sensor. See Chapter 10 - Troubleshooting for more information about these situations and what to do. The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 77: Checking Blood Glucose With The Meter
See Chapter 10 - Troubleshooting for more information about these situations and what to do. IMPORTANT: Use the Meter that is paired with Bigfoot Unity when checking blood glucose. If you use a different meter, blood glucose values will not display on the White Cap.
Page 78: Viewing Correction Dose Amount On The White Cap
Result screen using Sensor scan reading Meter measurement • Bigfoot Unity will first determine which Correction range your most recent Sensor scan or Meter measurement falls within. The Correction units are the units associated with that range. Correction ranges and units are those that you entered in the App.
Page 79: Viewing Meal Dose Amounts On The White Cap
• Neither Mealtime nor Correction Insulin units will appear on the display if you turned these features off in the App. The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 80 • Bigfoot Unity only records doses taken with the insulin pens you use with the Caps. If you take a dose of insulin without using Bigfoot Unity, make sure you keep track of the time you took insulin and check your glucose frequently.
Page 81: Using Your Caps When Replacing Insulin Pens
Every time you remove the Cap for 4 or more seconds and place the Cap back on the pen, Bigfoot Unity thinks you took a dose of insulin and re-starts counting the “time since last dose.”...
Page 82: Making Diabetes Treatment Decisions
Work with your health care provider to put together a plan for managing your diabetes that includes when to scan your Sensor and how to use Bigfoot Unity information for making treatment decisions. Treatment decisions for your diabetes management include dosing insulin, treating a low or high glucose result, or choosing not to act.
Page 83 (fingersticks), particularly during times when your blood glucose is changing quickly. If your glucose readings and alerts from Bigfoot Unity do not match your symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions.
Page 84: When Not To Use Sensor Glucose For Treatment Decisions
Meter to make a treatment decision, there are times when you should act based on how you feel rather than relying on Bigfoot Unity. Review the following scenarios carefully as to when to use a blood glucose measurement from your Meter rather than a Sensor reading to decide what to do next.
Page 85: Considerations Before Injecting Rapid-Acting Insulin
• What do you do if your before meal glucose is high? • What do you do if your before meal glucose is low? • How much time do you wait to eat after taking your Mealtime Insulin? The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 86 • What do you do if your overnight glucose is low? Other factors • For Bigfoot Unity, given that the Trend Arrow is not used when providing a correction dose, how do you adjust your insulin dose based on the Glucose Trend Arrow? •...
Page 87: Considerations If You Record A Dose You Did Not Take
Considerations if You Record a Dose You Did Not Take Bigfoot Unity records that you took a dose of insulin every time the Cap is replaced after being removed for more than 4 seconds. This re-sets the dose timer and displays the “time since last dose” as 0 min 0 sec.
Page 88: Charging Your Caps
If Bigfoot Unity records a dose when you did not actually take one, you can “flag” the dose as “not taken” in the MY HISTORY List View section of the App. This will keep your dosing history more accurate in the App, but it will not change the “time since last dose” that is displayed on your Caps.
Page 89 4. Unplug the USB cable from the Cap and wall outlet. Note: Only use the USB 2.0 compatible cable with USB-C connector and the power adapter that is included with Bigfoot Unity for charging. The Bigfoot Unity Diabetes Management System User Guide | Chapter 6...
Page 90: Battery States
Battery States Battery symbols What it means No power remaining. (Charge Cap immediately.) 25% or lower (Charge Cap) 100% Cap is charging/charging cable plugged in The Bigfoot Unity Diabetes Management System User Guide | Chapter 6 ™...
Page 91: Using The Sensor
Using the Sensor 7.1 About your Sensor The Bigfoot Unity Diabetes Management System only works with ™ Abbott FreeStyle Libre 2 Sensors and cannot be used with other sensors. When in range of each other, your Sensor continuously sends glucose readings to your App/phone. Information about your glucose range or Sensor status is displayed on the Home screen.
Page 92: Sensor Kit
The Sensor can be worn for up to 14 days. Sensor Measures your glucose while on your body (only visible after applied). The Bigfoot Unity Diabetes Management System User Guide | Chapter 7 ™...
Page 93: Using Your Sensor
1 inch (2.5 cm) away from an insulin injection site. To prevent discomfort or skin irritation, you should select a different site other than the one most recently used. The Bigfoot Unity Diabetes Management System User Guide | Chapter 7 ™...
Page 94 Sensor Pack. On a hard surface, press firmly down on the Sensor Applicator until it comes to a stop. 5. Lift the Sensor Applicator out of the Sensor Pack. The Bigfoot Unity Diabetes Management System User Guide | Chapter 7 ™...
Page 95 9. Make sure the Sensor is secure after Application. Put the cap back on the Sensor Applicator. Discard the used Sensor Pack and Sensor Applicator according to local regulations. The Bigfoot Unity Diabetes Management System User Guide | Chapter 7 ™...
Page 96: Starting (And Scanning) A New Sensor
2. Discard the used Sensor following directions from your health care provider. See Chapter 9 - Care, Maintenance and Disposal of Bigfoot Unity. When you are ready to apply a new Sensor, follow the instructions in the Applying Your Sensor section in this chapter.
Page 97: Replacing Your Sensor
2. Discard the used Sensor following directions from your health care provider. See Chapter 9 - Care, Maintenance and Disposal of Bigfoot Unity. When you are ready to apply a new Sensor, follow the instructions in the Applying Your Sensor section in this chapter.
Page 98: Daily Use And Additional Features
® settings, you will be notified that you must set your phone settings properly in order to continue to use the Bigfoot Unity App. If Critical Alerts or Bluetooth settings are turned off, the Bigfoot Unity App will display a screen to inform you of which settings are not set properly or are “Off.”...
Page 99 • Sounds for Notifications are “On” • Lock Screen and Banners are “On” • Downtime and App Limits are “Off” in Screen Time (or if Downtime or App Limits are “On,” add the Bigfoot Unity App to Always Allowed) The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 100 Your App will indicate if Bluetooth is not turned on. You can only use the App for 4 hours after Bluetooth is turned off. • You must allow Critical Alerts for the Bigfoot Unity App to receive Bigfoot Unity Alerts, including the Very Low Glucose Alert, even when your phone is muted or set to “Do Not Disturb.”...
Page 101: Alerts
“Do Not Disturb.” It is possible to have multiple alerts active at any time. Always keep your Bigfoot Unity App open (do not force close) on your phone and keep your phone near you when you are wearing your Sensor (within 20 feet).
Page 102 See Appendix A for a complete list of Alerts you may receive on your phone/App, and recommended next steps. WARNINGS: • Do NOT ignore Alerts from Bigfoot Unity. Alerts help inform you about Sensor availability, low glucose, or if you may have missed your long-acting insulin dose. Paying attention to alerts can help prevent severe low or high glucose.
Page 103: Home Screen Glucose Ranges
See Chapter 10 - Troubleshooting for a complete list of Notifications, Alerts, and Home screen glucose ranges that might occur and suggestions for what to do. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 104: Home Screen Main Menu Options
• Blood glucose results from your Meter and long-acting and rapid-acting insulin injections from your Caps, appear as coded symbols at the time recorded for each event. Tap any symbol to display detailed information about the event. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 105: List View
Every time you remove the Cap for 4 or more seconds and place the Cap back on the pen, Bigfoot Unity thinks you took a dose of insulin and re-starts counting the “time since last dose.”...
Page 106: Dose Not Taken
Dose Not Taken If Bigfoot Unity records a dose when you did not actually take one, you can “flag” the dose as “not taken” in the MY HISTORY List View section of the App. This will indicate that the dose was never actually taken and will help keep your insulin dosing more accurate when viewing your history.
Page 107: My Devices (Status And Starting New Devices)
For example, if you pair a new White Cap, it will automatically unpair the current one. If you change insulins while using Bigfoot Unity, you may need a different Cap. In this case, you must contact Bigfoot Customer Care at (551) 244-3668 to obtain a new, compatible Cap.
Page 108: White Cap (Status And Start A New White Cap)
Meter. CAUTION: When you get a new Cap, always pair it using the Bigfoot Unity App on your phone. The pairing process sends your most recent insulin settings to the new Cap. If you do not pair your new Cap, you will not be able to use it.
Page 109: Black Cap (Status And Start A New Black Cap)
Black Cap. CAUTION: When you get a new Cap, always pair it using the Bigfoot Unity App on your phone. The pairing process sends your most recent insulin settings to the new Cap. If you do not pair your new Cap, you will not be able to use it.
Page 110: Meter (Status And Start A New Meter)
Phone Replacement If you replace your phone, you will need to download and re-install the Bigfoot Unity App on your new phone. Cloud data services will restore your previous diabetes settings in the App. You will also need to pair your Caps with the App on the new phone.
Page 111 Black Caps attached to your pens so you do not record an incorrect insulin dose. • Bigfoot Unity will first check if your previous insulin information is available in the cloud. If it is, the date of your last insulin settings is displayed.
Page 112: My Settings
App before they will be saved in the Caps. If you change your insulin brand, Bigfoot Unity will check to see if you need a new White or Black Cap that is compatible with your new insulin and instruct you accordingly.
Page 113 Save. Then follow the App prompts for turning the Black Cap on and sending insulin settings to your Black Cap (see Sending Insulin Updates to your Caps section that follows). The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 114 º Tap Cancel to cancel the change you made to your Insulin Name and return to the Insulin Settings screen where you can start over. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 115 4. If you choose to start over, tap Erase Example: Editing Rapid- acting insulin and doses all settings and start over. You will be prompted to confirm your selection by tapping Erase. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 116 Save. Then follow the App prompts for turning the White Cap on and sending insulin settings to your White Cap (see Sending Insulin Updates to your Caps section that follows). The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 117 This also includes pairing your new White Cap with your App and Meter, starting a new Sensor, and sending your updated rapid-acting insulin settings to the White Cap. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 118 Once insulin updates are saved in your App, you will need to send them to your Caps. Make sure you have your Caps available, turned on and within communication range of your phone. Bigfoot Unity will always check to see if you might already have updates pending before sending any new updates.
Page 119 Cancel to review and accept the pending update. See the Accepting pending insulin updates section that follows for more information on pending updates. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 120 Your previously saved long-acting insulin information will be displayed where you have the option to use or edit the information. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 121: Alerts
• When your glucose is low. • When your Sensor is unable to obtain and send a glucose reading or Alert to your App. • When Bigfoot Unity thinks you may have missed a long-acting insulin dose. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 122: Very Low Glucose Alert
Very Low Glucose Alert. You won’t be able to use the Bigfoot Unity App properly if Bluetooth or Critical Alerts are off. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 123: Low Glucose Alert
Alert to the App. - Slide the On/Off button to “On” or to “Off” to turn this Alert on or off. - Tap < Alerts to return to the Alerts screen. The Bigfoot Unity Diabetes Management System User Guide | Chapter 8 ™...
Page 124: Long-Acting Dose Alert
Long-Acting Dose Alert • The Long-Acting Dose Alert is triggered 9:41 9:41 9:41 when Bigfoot Unity thinks you have missed Alerts Long-Acting Dose a long-acting insulin dose from your Black Long-Acting Dose Cap. The pre-set duration time for this Alert When on, this alert notifies you when the last <Insulin>...
Page 125: My Data
My Data From the My Data menu option, you can generate your Bigfoot Unity Report. The Report is a 14 day retrospective review of your diabetes data that includes a standard set of glucose and insulin graphs and statistics. 1. Tap My Data on the My Settings screen. It may take a few moments for the App to generate your Report.
Page 126: Supplies
This will take you to the App-based videos and training you used when you set up the Bigfoot Unity System. • Tap Learn to Use Bigfoot Unity on the My Settings screen to view the in-App learning content. Help and Support Help and Support provides an easy way to access helpful information when using Bigfoot Unity.
Page 127: Care, Maintenance And Disposal Of Bigfoot Unity
Care, Maintenance and Disposal of Bigfoot Unity 9.1 Living with your Bigfoot Unity Diabetes ™ Management System Activity What to do Bathing, Your Caps should not be used or carried when Showering, bathing, showering or swimming. and Swimming Your Sensor is water-resistant and can be worn while bathing, showering, or swimming.
Page 128 (continued) If you update the date and time manually, you will not be able to use Bigfoot Unity. You can safely use Bigfoot Unity at all times while on an aircraft. • The Caps are classed as Medical-Portable Electronic Devices (M-PED) that meet all...
Page 129: Cleaning
9.2 Cleaning Clean your Bigfoot Unity Cap as needed or if it is visibly dirty. Cleaning helps remove dirt or other residue from the surfaces of your Cap. Cleaning does not kill bacteria or viruses. If you get insulin on the Cap clean it off right away.
Page 130: Cleaning And Disinfecting Your Meter
If you receive new Caps, Bigfoot Biomedical will request that you return your old Caps. Instructions, packaging, and postage will be provided when you receive your new Caps. Other parts of the Bigfoot Unity System should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment, batteries, sharps, and materials potentially exposed to body fluids.
Page 131: Troubleshooting
Troubleshooting This chapter lists problems you may have with the Bigfoot Unity ™ Diabetes Management System, the possible cause(s), and recommended actions. IMPORTANT: Contact Bigfoot Biomedical by tapping Help and Support on the My Settings screen in the App or through the company website (support.bigfootbiomedical.com).
Page 132 Cap until the problem is resolved. What to do Contact Bigfoot Customer Care at (551) 244-3668 as soon as possible for assistance. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 133: Cap Display Issues
Meal + Correction unit amounts, you must have a valid Sensor glucose reading or a Meter glucose value from the White Cap within the last 10 minutes. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 134: Pairing And Communication Problems
What to do Make sure the App and Caps are within communication range (within 20 feet) of each other. Make sure that Bluetooth settings are enabled on your phone. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 135: Sensor
Sensor, it may mean that your body is still adjusting to the Sensor. Use your Meter to check your glucose while you wait. You do not need to remove your Sensor. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 136 What it may mean There is a problem with your Sensor. What to do Check your blood glucose with your Meter using a drop of blood from your fingertip. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 137 What to do Always use your White Cap to scan your Sensor to collect and display glucose data on your History screen. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 138: Low And High Sensor Glucose Messages
Monitor your glucose closely, and scan again in 15 minutes. Treat low glucose according to your health care provider’s recommendations. Use your Meter to check your glucose if it’s still within 12 hours of wearing your Sensor. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 139 (> 400 mg/dL). What to do Treat very high glucose according to your health care provider’s recommendations. When necessary, use your Meter to check and obtain a glucose value. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 140: Sensor Wear Problems
Sensor application site. What to do If the irritation is where the adhesive touches skin, contact your health care provider to identify the best solution. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 141: Meter
Contact Bigfoot Customer Care at (551) 244-3668 to request a replacement Bigfoot Meter. Only a Meter supplied by Bigfoot should be used with Bigfoot Unity. Refer to your backup plan for obtaining a blood glucose result while you await a new Meter.
Page 142 50°F to 104°F (10°C to 40°C). Wait for your Meter and test strips to reach the new temperature (usually 10-20 minutes) before using your Meter or checking your blood glucose. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 143 Cap for the pairing to be successful. What to do Bring Meter next to the White Cap, wait for the Meter’s screen to turn off, and try again. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 144: App
Sensor and apply a new one. Problem What it may mean There is a problem with your Sensor. What to do Tap OK. Apply and start a new Sensor. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 145 There is a problem activating your Sensor. What to do Tap OK. Try starting the Sensor again with your Phone. If the problem persists, remove the Sensor and apply a new one. The Bigfoot Unity Diabetes Management System User Guide | Chapter 10 ™...
Page 146 What to do Bigfoot Unity lets you flag (mark) a rapid-acting or a long-acting insulin dose as “not taken” in the MY HISTORY List View section to remind you that the recorded dose was not actually injected. Flagging (marking) the dose as “not taken”...
Page 147 Acting Dose Alerts. What to do Check that 1) all Alerts are “On” in your Bigfoot Unity App; 2) your phone’s Bluetooth setting is “On”; 3) you have allowed Critical Alerts and Notifications to come through to your phone; 4) phone sounds/ vibrations for Notifications and Alerts are “On”;...
Page 148 What to do Check your Bigfoot Unity App screen to see which settings are “Off.” To set phone settings properly in order to receive alerts, tap Go to Phone Settings to manage these settings. You can choose to dismiss for up to a total of 4 hours.
Page 149: Appendix A: Receiving And Responding To
Appendix A: Receiving and Responding to Notifications/Alerts on Your App/Phone Bigfoot Unity is designed to make you aware of situations regarding your glucose readings and Sensor, including those that require your immediate attention. You can change how you receive certain Notifications and Alerts by going to MY SETTINGS on the Home screen and Settings on your phone.
Page 150 100 mg/dL and 180 mg/dL). What to do Monitor your glucose with your Sensor or Meter. Follow your health care provider’s recommendations for managing your glucose in this range. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 151 Notification What it may mean Your Sensor glucose is at the high end of the Bigfoot Unity factory-set target range (between 181 mg/dL and 250 mg/dL). What to do Monitor your glucose with your Sensor or Meter. Follow your health care provider’s recommendations for managing your glucose in this...
Page 152 Sensor. What to do Make sure your phone/App is within communication range (20 feet) of your Sensor and Bluetooth connection is “On.” Replace the ® Sensor if necessary. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 153: Alerts
Alert will repeat in 45 minutes unless Sensor glucose rises above 80 mg/dL. If you do not tap OK, Alert will repeat every five minutes. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 154: Sensor Unavailable Alerts
App/phone. If you do not tap OK, Alert will repeat every five minutes until the Sensor is able to communicate with the App/phone. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 155 At that time, glucose alerts will resume. If you do not tap OK, Alert will repeat every five minutes until the Sensor is able to communicate with the App/phone. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 156 App/phone. At that time, glucose alerts will resume. If you do not tap OK, Alert will repeat every five minutes until the Sensor is able to communicate with the App/phone. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 157: Permanent Sensor Loss Alerts
Sensor and wait for Sensor to begin sending glucose readings to your App/phone. At that time, glucose alerts will resume. If you do not tap OK, Alert will repeat every five minutes. The Bigfoot Unity Diabetes Management System User Guide | Appendix A ™...
Page 158: Long-Acting Dose Alert
Long-Acting Dose Alert Alert What it may mean Bigfoot Unity thinks you may have missed your long-acting insulin dose since it did not record a dose with the Cap in the time period you set for keeping track of long-acting insulin dosing.
Page 159 Appendix B: Settings for Bigfoot Unity App Appendix B: Settings for Bigfoot Unity App Information to Enter in the App CAUTION: Bigfoot Unity does not support insulin doses in half-unit increments. B.1 Information to Enter in the App Long-Acting Insulin...
Page 160 Choose one approach from below Notes Important: Bigfoot Unity will not display a correction dose if you have taken rapid-acting insulin in the past 3 hours. Speak to your health care provider about how to avoid “stacking” doses of rapid-acting insulin to prevent low glucose in the hours after the injection.
Page 161 What it means Consult instructions for use Temperature Manufacturer Batch code Type BF applied part Use-by date Catalog number Serial number Keep dry Non-ionizing radiation CODE Sensor code The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 162 This product contains electronic equipment, batteries, sharps and materials that may contact bodily fluids during use. Dispose of product in accordance with all applicable local regulations. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 163 > 12 mm diameter Operating and -1,250 ft (-381 m) to 10,000 ft (3,048 m) storage altitude 2.402 to 2.480 GHz BLE; GFSK; 0dBm Radio Frequency EIRP The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 164 Part Number BFMHP-BF-0002 (Bigfoot Biomedical PN-300008) USB 2.0; Model: A18A-050100U-US2 Adapter Type (Bigfoot Biomedical PN-300007) Supply Input 100-240 V AC, 50/60 Hz, Max 0.2A Supply Output 5 V DC, 1A The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 165 NFC scan distance 1.0 cm Near Field Communication (13.56 MHz Radio Frequency RFID); 2.402 to 2.480 GHz BLE, GFSK C.5 Bigfoot Unity™ Diabetes Management System Specifications Bigfoot Unity System Specifications Operating 50 ºF to 95 ºF (10 ºC to 35 ºC) Temperature C.6 Kit Specifications...
Page 166 C.9 Meter Specifications See the instructions that came with your Meter and the inserts that came with your test strips and control solution for specifications for those devices. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 167 * The contents of this section are based on clinical studies conducted by Abbott Diabetes Care in support of the FreeStyle Libre 2 Flash Glucose Monitoring System (K193371). This summary includes elements of the studies that support features present in Bigfoot Unity. Data from these studies that do not support features in Bigfoot Unity are not included.
Page 168 The results categorized within CGM glucose ranges are presented in Tables 1b and 1c. The results categorized within YSI glucose ranges are presented in Tables 1d and 1e. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 169 54 – 3028 94.7 98.6 100.0 10.2 70 – 7504 77.5 86.9 99.4 -4.8 10.4 181 – 2937 87.9 93.7 99.7 -8.0 > 250 4826 90.9 95.9 99.7 -11.8 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 170 ≥ 80 Cumulative % 20.0 40.0 40.0 80.0 20.0 * The User’s Manual for the FreeStyle Libre 2 Flash Glucose Monitoring System refers to these as ‘LO’ and ‘HI’ The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 171 Table 2d: Concurrence Analysis with ‘> 400 mg/dL’ CGM Reading (Pediatric; n=86) YSI (mg/dL) CGM-Reference Pairs > 350 > 300 > 250 ≤ 250 Cumulative % 86.7 93.3 100.0 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 172 251 – 66.9 22.7 2327 301 – 13.6 68.8 16.0 1522 351 – 27.5 63.3 > 400 † 62.8 34.7 Levels out of Libre 2 Sensor dynamic range. † The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 173 251 – 10.1 62.1 26.8 301 – 20.0 60.0 19.6 351 – 34.2 58.4 > 400 † 16.7 70.0 Levels out of Libre 2 Sensor dynamic range. † The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 174 251 – 23.7 66.0 2359 301 – 29.8 58.9 1777 351 – 34.7 48.1 10.8 > 400 16.7 42.6 38.9 * Levels out of Libre 2 Sensor dynamic range. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 175 11.6 251 – 35.9 52.1 11.5 301 – 34.8 53.3 10.0 351 – 47.3 46.3 > 400 26.7 70.0 Levels out of Libre 2 Sensor dynamic range. † The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 176 (0 to 1 mg/dL/min) 19.7% of the time, rising (1 to 2 mg/dL/min) 2.6% of the time, and were rising quickly (> 2 mg/dL/min) 1.2% of the time. The Bigfoot Unity System uses the FreeStyle Libre 2 Sensor’s Trend Arrow calculation; however, third party digitally connected systems that do not utilize these calculations may see different glucose rate of change accuracy.
Page 177 14.0% of the time a Low Glucose Alert was received when blood glucose wasn’t actually below the alert level. 89.3% of the time blood glucose was below the alert The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 178 ±15 mg/dL ±20 mg/dL ±40 mg/dL Beginning 6955 83.4 90.4 99.3 Early Middle 4522 87.7 94.5 99.8 Late Middle 3503 86.8 93.4 99.7 3755 86.4 92.9 100.0 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 179 Sensor. Of the 39 Sensors evaluated in this study, 97% lasted until the final day of use. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 180 Table 7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=87) Day of Wear Number of Sensors Survival Rate (%) 97.7 96.6 95.4 94.3 94.3 94.3 94.3 94.3 90.8 88.5 88.5 87.4 85.1 80.3 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 181 Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146) Day of Wear Number of Sensors Capture Rate (%) 98.3 98.1 98.3 98.3 98.4 98.3 98.4 98.4 98.4 98.4 98.4 98.5 98.5 98.6 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 182 Table 8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=87) Day of Wear Number of Sensors Capture Rate (%) 95.4 95.2 95.6 95.7 95.9 96.1 96.5 96.8 96.9 96.9 96.9 97.1 97.1 97.2 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 183 Table 9b: Overall between Sensor Precision (Pediatric; n=86) Paired Absolute Paired Absolute Coefficient of Number of Difference Relative Variation (%) Paired Readings (mg/dL) Difference (%) Pediatrics ages 13.2 7659 12 – 17 The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 184 1000 mg dose of ascorbic acid. The maximum average sensor bias after the three 1000 mg doses of ascorbic acid was less than 20 mg/dL. The Bigfoot Unity Diabetes Management System User Guide | Appendix C ™...
Page 185 Meter, or if Sensor or Cap data is not being sent to the App, it may be due to electromagnetic interference. To avoid interference, you may be able to move to a different location to Use Bigfoot Unity. Alternatively, you could turn off other nearby electronic devices or antennas to avoid interference.
Page 186 • Using only accessories, transducers, and cables specified by Bigfoot Biomedical. • Avoiding using Bigfoot Unity adjacent to other electrical equipment, or if adjacent use is necessary, Bigfoot Unity should be observed to verify normal system operation. FCC Compliance The Bigfoot Unity System complies with Part 15 of the Federal...
Page 187 Biomedical could void the user’s authority to operate the equipment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Bigfoot Unity is intended for use in the electromagnetic environment specified below. The customer or the user should assure that Bigfoot Unity is used in such an environment.
Page 188 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Bigfoot Unity is intended for use in the electromagnetic environment specified below. The customer or the user should assure that Bigfoot Unity is used in such an environment. IEC 60601 Compliance Electromagnetic Immunity test...
Page 189 If the measured field strength in the location in which Bigfoot Unity is used exceeds the applicable RF compliance level above, Bigfoot Unity should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating Bigfoot Unity.
Page 190 (about 3 feet), none of these products affected the operation of Bigfoot Unity. Recommended separation distances between transmitters and Bigfoot Unity can be calculated using the table below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter...
Page 191 31, 112 Setup Applying Sensor 25, 57, 93 Arrows Glucose trend Backup diabetes management plan 18, 20, 88, 106, 141 Bigfoot Unity Report Black Cap 13, 48, 65, 109 Blood glucose 25, 77 Checking Meter 20, 54, 110 Bluetooth Settings...
Page 192 20, 98 Diathermy Disinfecting Meter Disposal Dose Correction 13, 33, 78, 86, 117 Long-acting 13, 32, 72, 113, 124 Meal 13, 33, 79, 85, 116 Not taken 87, 106 Download App The Bigfoot Unity Diabetes Management System User Guide ™...
Page 193 40, 78, 79 Correction dose table 36, 40 Correction factor 36, 40 Dose not taken 87, 106 Flag dose as not taken 88, 106 Long-acting 32, 113 Meal dose label 33, 115 The Bigfoot Unity Diabetes Management System User Guide ™...
Page 194 Meal/mealtime dose 33, 34, 79 Pens 28, 130 Rapid-acting 33, 74, 85, 115 Settings 32, 43, 112 Learn to use Bigfoot Unity List view Long-acting insulin 13, 32, 113 Low Glucose 76, 138 Low Glucose Alert 101, 102, 121, 123, 153...
Page 195 Start Black Cap 48, 109 Start Caps 48, 51, 107 Start Meter 54, 110 Start Sensor 57, 96, 107 Start White Cap 51, 108 Supplies 28, 112, 126 Symbols/icons 11, 161 System kit The Bigfoot Unity Diabetes Management System User Guide ™...
Page 196 20, 60, 76, 84, 91, 131, 138 Very Low Glucose Alert 101, 102, 121, 122, 153 Viewing glucose information on White Cap Viewing insulin information on Caps 72, 78 White Cap 13, 51, 64, 74, 108 The Bigfoot Unity Diabetes Management System User Guide ™...
Page 198 Phone: (551) BIGFOOT or 244-3668 (888) 523-3662 Web: www.bigfootbiomedical.com Bigfoot, Bigfoot Unity, and Unity are trademarks of Bigfoot Biomedical, Inc. Apple and iPhone are trademarks of Apple, Inc. FreeStyle, Libre and LibreLink are trademarks of Abbott Diabetes Care, Inc. All insulin brand names are trademarks of their respective holders.