™ User Guide
Welcome to Bigfoot Unity™ The Bigfoot Unity™ Diabetes Management System consists of a set of 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.1 • Do the math for you to calculate the correction and meal doses recommended by your health care provider.
Table of Contents 1 Tips for Reading and Understanding this User Guide 1.1 Abbreviations and Conventions used throughout this User Guide, the App and Cap displays 10 1.2 Symbols that appear in this User Guide, the App and Cap displays 11 1.3 Customer Care and Technical Service 11 2 Before you Begin Using Bigfoot Unity 2.1 Overview 12 2.2 The Bigfoot Unity App 12 2.3 The Black Cap for Long-Acting Insulin 13 2.4 The White Cap for Rapid-Acting Insulin 13 2.
4 Bigfoot Unity Welcome Kit 4.1 Working With Your Health Care Provider 27 4.2 Bigfoot Unity Welcome Kit Package Contents 27 4.3 Compatible Insulin Pens 28 4.4 Compatible Insulin Pen Needles 29 4.5 Compatible Mobile Phones 29 5 First Time Setup of Bigfoot Unity 5.1 Getting Ready to Set Up Bigfoot Unity 30 5.2 Download the App and Create an Account 31 5.
Using Bigfoot Unity Caps 6.1 Pairing the Black and White Caps 69 6.
.2 Starting (and Scanning) a New Sensor 95 7.3 Removing your Sensor 95 7.4 Replacing your Sensor 96 8 Daily Use and Additional Features 8.1 Home Screen 97 Home Screen Glucose Ranges 98 Alerts 99 Home Screen Main Menu Options 101 8.2 MY HISTORY 102 Graph View 102 List View 103 Dose Not Taken 104 8.
9 Care, Maintenance and Disposal of Bigfoot Unity 9.1 Living with your Bigfoot Unity™ Diabetes Management System 124 9.2 Cleaning 126 Cleaning the Outside of the Cap 126 Cleaning the Inside of the Cap 126 Cleaning and Disinfecting your Meter 127 9.3 Pen Needles 127 9.4 Insulin Pens 127 9.5 Disposal 127 10 Troubleshooting 10.1 Caps 128 Usage Notifications 128 Cap Display Issues 130 Pairing and Communication Problems 131 10.
Appendix B: Settings for Bigfoot Unity App B.1 Information to Enter in the App 154 Long-Acting Insulin 154 Rapid-Acting Insulin 154 Notes 155 Appendix C: Technical Information C.1 Labeling Symbols 156 C.2 Sensor Specifications 158 C.3 Cap Specifications 159 C.4 Communications Specifications 160 C.5 Bigfoot Unity™ Diabetes Management System Specifications 160 C.6 Kit Specifications 160 C.7 Security Measures 161 C.8 Quality of Service (QoS) 161 C.9 Meter Specifications 161 C.
1 1 Tips for Reading and Understanding this User Guide Before starting to use the Bigfoot Unity™ Diabetes Management 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. To start using Bigfoot Unity, download the Bigfoot Unity App on your mobile phone and create an account.
1.2 Symbols that appear in this User Guide, the App and Cap displays Symbol What it means Warning, Caution, Precaution, Limitation or other safety issue that requires immediate attention. Low glucose (possible hypoglycemia). Sensor not able to provide glucose readings or glucose alerts. Possible missed insulin dose from your long-acting insulin pen. Information previously saved and can be edited/ updated. Battery icon indicating how much battery power remains in Caps.
2 Before you Begin Using Bigfoot Unity 2.1 Overview The Bigfoot Unity™ Diabetes Management System is designed to help persons with insulin-requiring diabetes manage their insulin pen injections and glucose levels. Although the actual decision on how much insulin to take is yours, Bigfoot Unity can help you with this decision by displaying how long it has been since your last insulin dose, your current glucose level, and your health care provider’s insulin recommendations.
2.3 The Black Cap for Long-Acting Insulin Example: Black Cap with insulin pen The Black Cap is designed to help you remember the long-acting insulin dose that your health care provider recommends and shows how long it has been since you took your last dose of long-acting insulin. It replaces the cap that came with your long-acting insulin pen. You can choose to receive an alert on your phone to let you know if you may have missed a long-acting insulin dose.
The White Cap can also display the amount of Correction Insulin and Mealtime Insulin based upon the settings your health care provider has recommended for you. If you take an insulin dose, the time of the last dose is displayed on the Cap and sent to the App. 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.
2.7 About Cloud Services and Wireless Communication The White and Black Caps use Bluetooth® communication to share data with the App on your phone. Your phone must have internet service through a cellular or 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 you share your data with your health care provider.
3 Indications and Safety Information 3.1 Indications for Use The Bigfoot Unity™ Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring Sensor. The System incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
• Letting you easily set up and adjust your insulin and insulin dosing information on your phone and having that information displayed on your Caps to use when you need to inject a dose. • Scanning your Sensor with your White Cap to view your current glucose level and Trend Arrow at the time you dose. • Recording the last time you dosed insulin, and doing some of the calculations for deciding how much insulin to take to cover meals and/or bring down a high glucose.
• 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. Bigfoot Unity has no way of ensuring that the information you have entered 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.
3.4 Who should not use Bigfoot Unity CAUTIONS and LIMITATIONS • Do NOT use in people less than 12 years of age. Bigfoot Unity is not cleared for use in people under 12 years of age. • Do NOT use if you are pregnant, on dialysis or critically ill. Bigfoot Unity is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may affect performance.
• Do NOT use cell phone adapters or other third party USB cables to charge medical devices including the Bigfoot Unity Caps. Connecting the Caps to any device other than the supplied USB charging cord and power adapter may result in electrical shock. 3.6 Cap and App Usage What to know Before you Begin Use WARNINGS • Do NOT ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care provider.
• 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. • Use caution when using Bigfoot Unity to choose an insulin dose if the Cap does not display the time since last dose or if you think the time since last dose is not correct.
What to know about Setting up Notifications and Alerts WARNINGS • You must allow Notifications for the Bigfoot Unity App in order to receive Bigfoot Unity Alerts even when your phone is locked and not showing the Bigfoot Unity App. Remember also to keep your phone sufficiently charged to receive alerts.
3.7 Sensor Glucose What should you know about Wearing a Sensor CAUTIONS and LIMITATIONS • Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off early.
• Do NOT re-use Sensors. The Sensor and Sensor Applicator are designed for single-use. Re-use may result in no glucose readings and infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results. • If a Sensor breaks inside your body, call your health care provider. How to Store the Sensor Kit • Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
• Clean hands prior to Sensor handling/insertion to help prevent infection. • Change the application site for the next Sensor application to prevent discomfort or skin irritation. • Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly. • Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps.
3.8 Interfering Substances Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins.
4 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. This information is entered in the App where it is stored and available as needed for you to make changes. A reference tool is available in Appendix B for you to use with your health care provider. 4.
E - USB Power Adapter for charging Caps F - USB C charging cord to charge both Caps G - Alcohol Prep Pads H - Bigfoot Pen Needles I - User Guide Note: Do NOT connect the Caps to any device other than the supplied USB charging cord and power adapter. If you need a replacement USB charging cord or power adapter, or any other parts or accessories, contact Bigfoot Customer Care at (551) 244-3668. Check Shipments of Supplies and Equipment Check that your packaging includes all of the items listed above.
4.4 Compatible Insulin Pen Needles The Bigfoot Needles that come with Bigfoot Unity are designed to fit your insulin pens. Visit www.bigfootbiomedical.com/compatible for compatible insulin pen needles. 4.5 Compatible Mobile Phones The App works on your compatible personal, mobile phone. Visit www.bigfootbiomedical.com/compatible for the current list of compatible phones.
5 5 First Time Setup of Bigfoot Unity 5.1 Getting Ready to Set Up Bigfoot Unity The App will walk you through the steps for setting up and using the Bigfoot Unity™ Diabetes Management System. You may also refer to other sections in this User Guide for additional information on using 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 ) to proceed.
5.2 Download the App and Create an Account 1. 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. 2. Launch the App on your phone. 3. Tap Create Account on the Welcome screen. 4. Enter your first and last name, your email address, a password and tap Next to continue. • A link will be sent to the email address you entered. Click on the link in the email to complete the email verification.
5. Login to your account with your email address and password Note: If you forget your App password when you log in, tap Forgot Password? on the Login screen. Instructions for re-setting your password will be sent to your email address. 6. Review the Terms and Conditions by tapping Terms of Use. On the initial Terms of Use screen, tap Agree on the lower right of the screen to continue. • Your App account is now set up and ready for use.
Enter Insulin Settings You are now ready to enter your insulin settings in the App, and how you want your phone to notify you of certain events. You will need insulin information from your health care provider to complete this section. Entering Long-Acting Insulin Settings 1. Tap Enter Insulin Settings. 2. Once you have your insulin information from your health care provider (see Appendix B) tap Next on the Enter Insulin Settings screen. 3.
Entering Rapid-Acting Insulin Settings 1. Select your rapid-acting insulin by tapping on the insulin you use. Mealtime Insulin Bigfoot Unity lets you enter how much rapidacting insulin you take for meals (Mealtime Insulin). 1. Use the insulin settings sheet from your health care provider (see Appendix B) to determine Mealtime Insulin selection. • If Mealtime Insulin is recommended, tap Yes, Enter Mealtime Insulin.
Small, Medium, Large: Based on how certain meal sizes affect your glucose In this category, enter the units of rapid-acting insulin to account for how large an effect meals have on your glucose. For practical purposes, you may consider this category as covering a small, medium, or large amount of carbs in your meal. Breakfast, Lunch, Dinner: Based on how meals at certain times of the day affect your glucose In this category, enter the units of rapid-acting insulin you take for each type of meal.
Mealtime insulin - Most common Meal times (Breakfast, Lunch and Dinner) • Tap the first meal time. Then scroll to the insulin units (0 to 80) to select the amount you typically take to cover that meal time and tap Done when you are finished. • Repeat for your second and third meal times. • Tap Next when you are finished. Mealtime insulin - Most common Carb Amounts • Tap a Carb Amount and then scroll to a common amount of grams of carbohydrate (0 to 125) in that meal and tap Done when you are finished.
Correction Insulin Bigfoot Unity lets you enter how much rapid-acting insulin you take to bring down a high glucose (Correction Insulin). 1. Use the insulin settings sheet from your health care provider (see Appendix B) to determine Correction Insulin selection. • If you do take insulin to bring down a high glucose, tap Yes, Enter Correction Insulin. • If you don’t take insulin to bring down a high glucose, tap No, I Don’t Take Correction Insulin to skip this section.
Enter your Correction Dose Table The Correction Insulin screen displays six pre-set, but adjustable, glucose correction ranges. For each glucose range you will enter the units of rapid-acting insulin you typically take to bring down a high glucose. Pre-set ranges, along with their upper and lower limits, will be displayed the first time you set up the App. The number of insulin units that apply to each range will be empty (blank).
2. Then tap the number range to change to the desired values. Scroll through the range values (between 100 and 400 mg/dL) to select your new range limits and then tap Done. Once a new range limit is selected, the lower limit of the next range is automatically adjusted to start at 1 plus the upper limit of the range you just changed. When you adjust a range so that it overlaps another range in its entirety, that range will be deleted. • To delete a range, first tap the edit icon ( ) next to the range.
Enter/modify your units 1. Tap the insulin units for the first range. 9:41 Back Insulin Settings Edit Correction Insulin Enter the units of for each range below. GLUCOSE RANGE (mg/dL) (units) 1 150 - 200 201 - 250 2 251 - 300 3 301 - 350 4 351 - 400 5 6 Over 400 Need help? Next 2. Enter the desired units (0 to 40) by scrolling through the units for that range and then tap Done. • Repeat this step to enter the units for other ranges.
Enter your Glucose Target and Correction Factor With this option, the Correction Table will fill in when you enter these two values. When you enter a Glucose Target or Correction Factor, any previous Correction Dose Table values will be replaced by new values. 1. Enter your Glucose Target (100 to 250 mg/dL), then tap Done. Your Glucose Target is the number you aim for to correct your high glucose. Note that your Glucose Target may be different from the glucose value that you typically like to be at. 2.
3. When you tap Next, your Correction Dose Table will be completed automatically using the Glucose Target and Correction Factor just entered. Each row of the new table represents a glucose range. The lower limit of the first range is your Glucose Target plus your Correction Factor. The higher limit of the first range is your Glucose Target plus 2 times your Correction Factor.
2. Tap the Notes entry box and use the pop-up keyboard to enter your new Note. • More than one Note can be entered in the same box. • While entering Notes, the App will display a menu of text formatting options. • Tap the camera icon ( ) to add photos to your Notes. You have the option to add a stored photo, or take a new photo with your phone. 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.
Review Insulin Settings You must do a review of any insulin settings you made before you can complete this Setup section. Carefully check your entries on each screen to make sure that they are correct. This information will be sent to your Cap and used to display your insulin dosing information. You can make any edits during your review. 1. Tap Let’s Review. 2. Check your entries on the Review and Confirm Long-Acting Insulin screen.
4. Check your entries on the Review and Confirm Notes screen. You may need to swipe up (scroll) to see all your entries. • This screen lets you confirm, add or delete Notes. • Tap Confirm to accept the entries or Edit to update any entries. Note: If you make any changes, tap Next to return to the Review and Confirm Notes screen. Then tap Confirm to continue with the next step. After tapping Confirm, the Enter Settings screen will be displayed.
4. Tap Allow to allow Critical Alerts on your phone. Critical Alerts will come through to your App/phone on your lock screen even if your phone is muted or “Do Not Disturb” is on, as long as the App is open or running in the background. After tapping Allow, the Enter Settings screen will be displayed. A check mark ( ) will indicate that the Set Phone Notifications section is complete. 5. Tap Done.
5.4 Set Up Devices In this App Setup section, you will learn about your Bigfoot Unity devices and how they are connected. Certain Bigfoot Unity devices need to be paired with one another to share information. The Caps communicate with the App using Bluetooth® Low Energy (BLE) technology. The Sensor communicates with the App also using Bluetooth Low Energy technology, and also separately with the White Cap using a different method called near-field communication (NFC).
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 longacting insulin pen for this section. Your Black Cap is used to replace the cap on your long-acting insulin pen. “Long-Acting” will be displayed on your Black Cap when you remove it from the box. 1. Tap Start Black Cap. 2. Tap Next.
3. Review your long-acting insulin information. • Tap Confirm to continue. • Tap Edit to make changes. Make sure the Bluetooth phone setting is “On” in your phone. The App will remind you if the Bluetooth setting is not turned on. Bluetooth communication is automatically enabled in your Black Cap whenever you power it on. 4. Press the Black Cap button once to turn it on. The Cap display will prompt you to follow the instructions in the App for pairing.
5. Tap the Serial Number on the App screen that matches the Serial Number on the back of your Black Cap. If more than one number is displayed, make sure the Serial Number on the screen selection matches the Serial Number on the Black Cap you intend to use. The App will begin to pair with the selected Black Cap. Once the pairing is complete, the App and Cap will indicate that pairing was successful and the App will send your long-acting insulin information to the Black Cap. 6. Tap Next to continue.
8. Replace the original insulin pen cap with the Black Cap and leave Black Cap on pen unless taking insulin. Then tap Next. The Set Up Devices screen will be displayed. A check mark ( ) will indicate that the Start Black Cap section is complete. Start White Cap You will need your White Cap and rapid-acting insulin pen for this section. Your White Cap is used to replace the cap on your rapid-acting insulin pen. “Rapid-Acting” will be displayed on your White Cap when you remove it from the box. 1.
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. 4. Press the White Cap button once to turn it on. The Cap display will prompt you to follow the instructions in the App for pairing. The App will automatically search for and display the Serial Numbers of any White Caps it finds within range. Go to App App Display White Cap Display 5.
6. Tap Next to continue. Note: If the White Cap turns off before pairing is complete, press the White Cap button again to turn it back on. If pairing is still unsuccessful, see Chapter 10 - Troubleshooting for more information. 7. Confirm that the insulin brand name displayed on the White Cap matches the name on your rapid-acting insulin pen. • If the names match tap Yes, the insulin names match to continue. • If the names don’t match, tap No, the insulin names don’t match.
Start Meter Note: You will need your White Cap and Meter for this section. You are only able to pair your White Cap to the Meter supplied by Bigfoot 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.
4. With the Cap attached to the insulin pen, press the button on the White Cap to wake it up. The Cap display will indicate it is searching for your Meter. App Display White Cap Display The App will automatically search for and pair with the first Meter it finds within range. 5. Confirm that the code displayed in the App matches the code displayed on the Meter you intend to use.
• If the codes match, tap Confirm, and proceed to the next step. • If the codes do not match, tap Doesn’t Match to display a list of Meters (codes) within range and tap the Meter (code) you intend to use. White Cap Display App Display Meter Display Once the pairing is complete, the White Cap and Meter will indicate that pairing was successful. White Cap Display App Display Meter Display 6. Tap OK. The Set Up Devices screen will be displayed.
Start Sensor Have your White Cap available when you start a new Sensor. Starting your Sensor involves applying a new Sensor, starting it with your App/ phone, and then scanning it with your White Cap. See Chapter 7 Using the Sensor for information on how to apply a Sensor. 1. Tap Start Sensor. 2. Tap Next. 3. Apply a Sensor to the back of your upper arm (see Chapter 7). Decide if you want to view a series of informational screens about how to apply a Sensor. • Tap Next if you want to skip these screens.
4. With the Cap attached to the insulin pen, press the White Cap button once to turn it on. 5. When the App and Cap are communicating, the Start Sensor with Phone screen will be displayed. 6. Decide if you want to view a series of informational screens about how to start (scan) a Sensor. • Tap Start New Sensor to proceed. • Tap How to scan the Sensor if you want the informational screens displayed 7. Touch the top of your phone over the Sensor insertion area as shown until the phone beeps or vibrates.
• Wait for the App to confirm that the Sensor was started. A check mark ( ) will indicate that the Sensor was successfully started. Tap OK. Note: If there is a problem with starting your Sensor, you will be prompted to try starting the same Sensor again or using a new, replacement Sensor. Tap OK. See Chapter 10 - Troubleshooting for more information on problems with starting and scanning your Sensor and recommended next steps. 8.
10. Wait for the App and White Cap display to confirm that the Sensor was started. Your Sensor requires a 60 minute start-up period and no Sensor glucose values will display during this time. During this time, use your Meter to make treatment decisions. Sensor readings will be available in 60 minutes. App Display White Cap Display Note: After the 60 minute start-up period but during the first 12 hours after Sensor insertion, Sensor readings will be accompanied by a “Use Meter” message.
5.5 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.
Monitoring Glucose This section will review how to monitor your glucose with Bigfoot Unity. 1. Tap Monitoring Glucose. 9:41 Back Learn to Use Bigfoot Unity In this section, you will learn about: Monitoring Glucose Using the White Cap for Using the Black Cap for Important Reminders ) to start 2. Tap the play button ( watching a short video clip. 3. When done watching, tap Next to begin displaying a series of Knowledge Review screens.
4. Tap Next (or I Understand) at the bottom of each screen to continue to the next one. After tapping Next (or I Understand) on the last Knowledge Review screen, you will be prompted to check your knowledge. 5. Tap Let’s Go! 6. Follow the series of screen prompts to answer the Knowledge Check questions. • The App will confirm if your answer was correct or explain why it was wrong. • Tap Next to continue to the next question. 7.
Using the White Cap for Rapid-Acting Insulin This section will review how to use your White Cap. 1. Tap Using the White Cap. 2. Tap the play button ( short video clip. ) to watch a 3. When done watching, tap Next to begin displaying a series of Knowledge Review screens. • You can rewatch the video by tapping Watch Again. 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.
5. Tap Let’s Go! Check your knowledge to help you use the White Cap for with confidence. Let’s Go! 6. Follow the series of screen prompts to answer the Knowledge Check questions. • The App will confirm if your answer was correct or explain why it was wrong. • Tap Next to continue to the next question. 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 Using the White Cap section is complete.
2. Tap the play button ( short video clip. ) to watch a 3. When done watching, tap Next to begin displaying a series of Knowledge Review screens. • You can rewatch the video by tapping Watch Again. 4. Tap Next at the bottom of each Knowledge Review screen to continue to the next one. After tapping Next on the last Knowledge Review screen, you will be prompted to check your knowledge. 5. Tap Let’s Go! Check your knowledge to help you use the Black Cap for with confidence. Let’s Go! 6.
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. 2. After viewing the Important Reminder screens you will have an opportunity to practice with Bigfoot Unity. • Tap Let’s Go! 3. With the Cap attached to the insulin pen, follow the screen prompts for practice tips for using the Black Cap and White Cap.
4. After tapping Next on the last practice screen, Customer Care information will be displayed. • Tap Done. Congratulations on completing the App Setup.
6 6 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. The insulin settings from your health care provider, displayed directly on the Caps, is helpful information for you to consider when taking a dose of insulin from the pens.
CAUTION: Make sure your phone is within communication range (within 20 ft) of your Caps after you make any changes to your insulin settings within the App. If your Caps do not have the most current settings, you could take too much or too little insulin, which may result in severe low or high glucose. Insulin information that appears on your Caps is based on what you and your health care provider have entered in your App. Within the App, you can choose to turn certain features on or off.
It is important to always put the Caps back on your pens after an injection so the timer accurately tracks when you took your last dose. Placing the Cap back on the pen will re-set the timer to 0 hr 0 min. The timer re-sets whenever a Cap is removed for more than 4 seconds and placed back on the pen. If you place the Caps back in less than 4 seconds, the timer will not restart and a dose will not be recorded.
The insulin name is stored in the Cap, is shared with the App, and will be available on your Cap display the next time you want to dose insulin. Your Cap display will inform you if you have removed the insulin pen from the Cap. Note: • Once you take the Cap off the insulin pen, it will no longer show your time since last dose or insulin dose recommendations. Make sure to determine how much insulin to take before removing the Cap from the insulin pen.
4. Press the Black Cap button again to go back to the Time Since Last Dose screen 5. Consider what steps to take based on the information on the Black Cap and your health care provider’s recommendations, including how much insulin to dose from your pen. • To dose insulin from your long-acting insulin pen, first remove the insulin pen from the Black Cap. Follow the manufacturer’s instructions for delivering a dose based on the type of pen and insulin you are using.
Viewing Time Since Last Rapid-Acting Dose on the White Cap You will need to press the White Button more than once to continue displaying information on the Cap display, and to continue to the next screen. The number of button pushes is a function of whether you have enabled the Correction Insulin and Mealtime Insulin features. 1. When the White Cap is powered off it displays the rapid-acting insulin name you entered in the App. 2. Press the White Cap button once to turn the Cap on.
Scanning the Sensor with the White Cap Scanning your Sensor means turning the White Cap on and touching the screen side of the Cap to the Sensor to obtain Sensor glucose readings. The Cap must be within 1.0 cm of the Sensor. Your current Sensor glucose reading will be sent to the Cap, and the past 8 hours of Sensor glucose readings that are available will be sent to the App. Those 8 hours of historical glucose data will be viewable within the MY HISTORY feature in the App.
Understanding Glucose Trend Arrows and Glucose Messages Glucose Trend Arrows and What They Mean Arrow What it means Glucose is rising quickly (more than 2 mg/dL per minute) Glucose is rising (between 1 and 2 mg/dL per minute) Glucose is changing slowly (less than 1 mg/dL per minute) Glucose is falling (between 1 and 2 mg/dL per minute) Glucose is falling quickly (more than 2 mg/dL per minute) Glucose Messages and What They Mean • There are times when a “Low Glucose” or “Going Low” message will appear alon
Checking Blood Glucose with the Meter Checking your blood glucose means using your Meter to measure your glucose from a drop of blood from your fingertip. Results from your Meter will be sent to the White Cap when the Meter is paired to it and within communication range (within 20 ft). See the instructions that came with your Meter for more details on how to use the lancing device, the Meter and all safety information. 1.
Viewing Correction Dose Amount on the White Cap 1. Continue from the previous steps for viewing the time since last dose and viewing your current Sensor or Meter glucose reading. 2. View your Correction Insulin units. • If you set up Correction Insulin as part of your insulin settings in the App, the White Cap display will show a Correction Insulin unit amount as part of your result screen. A Meter value will be sent to the White Cap only if the blood glucose result was recorded within the past 10 minutes.
Viewing Meal Dose Amounts on the White Cap 3. Continuing from the previous steps for viewing Correction Insulin units, press the White Cap button to continue. 4. View your Mealtime Insulin Units. Example: Meal doses on White Cap screen • If Mealtime Insulin was entered in the App and the feature is turned on, the White Cap will display the information to help you decide how much to take to cover your meal according to how you take Mealtime Insulin.
7. Consider what steps to take based on the information on the White Cap display and your health care provider’s recommendations, including how much insulin to dose from your pen. • To dose insulin from your rapid-acting insulin pen, first remove the insulin pen from the White Cap. Follow the manufacturer’s instructions for delivering a dose based on the type of pen and insulin you are using. • When you remove the insulin pen, the White Cap will indicate the White Cap is off.
6.3 Using your Caps when Replacing Insulin Pens When you have depleted your insulin pen and need to replace it with a new one, make sure you have your new insulin pen and empty pen with the Black or White Cap still on it. When you are ready to replace your empty insulin pen, remove the cap that came with your new pen, and quickly (within 4 seconds) insert your new pen into the correct Black or White Cap to avoid recording a false dose.
6.4 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.
Helpful Tips Confirm your Sensor glucose readings with your Meter until you understand: • Sensor accuracy may vary between Sensors. • Sensor accuracy may vary during a Sensor wear session. • Sensor accuracy may vary in different situations (meals, exercise, first day of use, etc.). • Scan your Sensor often to see how carbs, medication, exercise, illness, or stress levels impact your Sensor glucose readings.
When Not to Use Sensor Glucose for Treatment Decisions While certain Sensor readings and Glucose Trend Arrows (and accompanying messages) can be used to indicate when to use a blood glucose measurement from your 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.
Symptoms Don’t Match Readings There may be times when your symptoms don’t match your Sensor glucose readings. For example, you are feeling shaky, sweaty, and dizzy – symptoms you generally get when you have low glucose, but your glucose reading is within your target range. When symptoms don’t match readings, do a blood glucose test and treat based on that result. Don’t ignore symptoms that may be due to low or high blood glucose.
• Do you adjust the amount of Mealtime Insulin based on the number of carbs or how much you are planning to eat? • Do you adjust your Mealtime Insulin dose for high fat foods such as pizza? • Do you know how to adjust your insulin doses when drinking alcoholic beverages? High glucose corrections • Do you take extra insulin if your glucose is high? • How do you decide how much insulin to take for a high glucose? • How long do you wait between insulin doses to avoid insulin stacking? Bedtime • How often do
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. There are times that you may re-set the dose timer accidentally when you did not actually take a dose. Some examples of this might be: • Removing your Cap to check the insulin in your insulin pen takes longer than 4 seconds.
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. See the MY HISTORY section (8.3) for more information. CAUTION: When you flag an insulin dose as “not taken”, it is for your information only. It does not change the “time since last dose” displayed on the Caps.
The Time Since Last Dose screen will include a battery icon that indicates about how much battery power is left in the Cap. Always charge the Caps if you see the “Charge Cap” message or the symbol. CAUTION: Make sure to select a location for charging the Caps that allows the power adapter to be easily unplugged. Do NOT block access to the charger due to the potential risk of electrical shock.
Battery States Battery symbols What it means No power remaining. (Charge Cap immediately.
7 7 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. You may also receive alerts about low glucose or if your sensor is unavailable.
Sensor Applicator Applies the Sensor to your body. The Sensor measures and stores glucose readings when worn on your body. It initially comes in two parts: one part is in the Sensor Pack and the other part is in the Sensor Applicator. By following the instructions, you prepare and apply the Sensor on the back of your upper arm. The Sensor has a small, flexible tip that is inserted just under the skin. The Sensor can be worn for up to 14 days.
Applying Your Sensor 1. Apply Sensors only on the back of your upper arm. If placed in other areas, the Sensor may not function properly and could give inaccurate readings. The application of the Sensor is not approved for other sites. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during your normal daily activities (no bending or folding). Choose a site that is at least 1 inch (2.5 cm) away from an insulin injection site.
4. Line up the dark mark on the Sensor Applicator with the dark mark on the 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. 6. The Sensor Applicator is prepared and ready to Apply the Sensor. CAUTION: The Sensor Applicator now contains a needle. Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack. 7.
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. 7.2 Starting (and Scanning) a New Sensor Whenever you insert a new Sensor, you will need to start the Sensor from within your App. You will also need your White Cap as part of the process. 1. In the App and referring to Sensor (Status and Start a New Sensor) in section 8.
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. If you removed your last Sensor before it ended, you will be prompted to confirm that you would like to start a new Sensor when you initiate the start new Sensor process in the App. 7.
8 8 Daily Use and Additional Features 8.1 Home Screen The Home screen will display every time you open the App. The Bigfoot Unity™ Diabetes Management System is designed so that your Sensor is always communicating with the App regarding your glucose and Sensor status. The Home screen is where you have access to that information. The top of the Home screen is where you will receive information about your Sensor glucose reading and range, and the status of your Sensor.
Tap the “Notifications/Alerts Off” icon ( ! ) to display the current receiving status of Notifications and Critical Alerts on your App/ phone. To properly receive alerts, ensure the following are on: ON Tap Go To Phone Settings to adjust how you manage Notifications and Critical Alerts with Bigfoot Unity.
WARNING: Do NOT use the glucose ranges displayed in your App to make diabetes treatment decisions. Always use the White Cap to scan the Sensor or read the Meter before deciding appropriate treatment. The App only displays ranges of glucose values and you need more specific information for diabetes treatment decisions. If you base your treatment on the glucose range in the App, you might take too much or too little insulin, which may lead to severe low or high glucose.
acting insulin helps ensure that you will receive the Long-Acting Dose Alert at the appropriate time. However, you should always check the Black Cap for the time since last dose to be sure. Alerts will display on your App. When multiple Alerts are active, you can swipe left to display the other Alerts. Active Alert screens appear in priority order, beginning with the most important. After tapping OK to acknowledge an Alert, the pop-up Alert screen will no longer appear on the Home screen.
WARNINGS: • Alerts and Notifications appear on the phone only and do NOT appear on the Caps or the Sensor itself. Make sure to have your Bigfoot Unity App and phone set up properly to receive alerts. Receiving Alerts and Notifications on your App/phone can help prevent severe low or high glucose. • Always check the Black Cap for the time since last dose if you receive a Long-Acting Dose Alert on your phone.
8.2 MY HISTORY In MY HISTORY, you can review available glucose data from your Sensor and Meter, and the time of insulin doses captured with the Caps. You can also review if any updates were made to your insulin settings. The App conveniently combines the data into a single view where you can see how insulin doses affect your glucose levels and helps you spot trends and patterns. Tap either selection on the screen.
List View The List View screen serves as a digital “Logbook” that displays key events captured over the past 48 hours, sorted by date and time for each event. The List View screen includes: • The time and result of your last scanned Sensor glucose reading, along with any Trend Arrow. • The time and result of your last blood glucose measurement taken with your Meter. • The time of your last rapid-acting and longacting insulin dose recorded with your Caps. • The time and type of any Alert.
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. • Tap the insulin dose you want to flag to display the “Dose Not Taken” flag. • Tap the “Dose Not Taken” flag. Dose • Then tap Flag Dose when prompted.
8.3 M Y DEVICES (Status and Starting New Devices) MY DEVICES lets you review the status of current connected Bigfoot Unity devices, start a new Sensor, connect a new Black or White Cap, and connect a new Meter. When starting a new White Cap, you will need your Meter to connect to it and you will need to start a new Sensor. Tap any device icon on the My Devices screen to display the device status and/or start the process for starting/connecting a new device.
White Cap (Status and Start a New White Cap) Shows the last time the App communicated with your White Cap. 1. Tap Start New White Cap to start a new White Cap. • When you start a new White Cap, you will also need to start a new Sensor and start/pair your 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. 2.
Black Cap (Status and Start a New Black Cap) Shows the last time the App communicated with your Black Cap. 1. Tap Start New Black Cap to start a new 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. 2. You will be prompted to have your new Black Cap ready. Tap Yes, I have my new Cap to continue.
Meter (Status and Start a New Meter) Shows the last time your blood glucose reading was sent from your Meter to the White Cap. 1. Tap Start New Meter to start a new Meter. 2. Repeat the steps for starting a new Meter (see Start Meter section in Chapter 5). You can tap < Back to return to the Meter device screen if you do not want to proceed. Phone Replacement If you replace your phone, you will need to download and re-install the Bigfoot Unity App on your new phone.
3. You have the option to restore your previous insulin settings or create new insulin settings. Remember, when you are setting up a new phone, follow the App instructions for when to leave the White and 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.
6. When you are finished reviewing your Notes, tap Confirm to restore your previous insulin settings. • A confirmation screen with a check mark ( ) will indicate that your previous insulin settings have been restored. Tap Done. 7. Tap OK and repeat the steps for starting your Caps with your new phone. 8.4 MY SETTINGS Your name (account name) will appear at the top of the My Settings screen. Tap your name to access and update your account information by selecting your name.
Making changes to your insulin settings Notes View and edit your Notes as needed. 1. Tap Insulin Settings on the My Settings screen. 2. Tap Notes to display your current Notes. Example Notes • To edit, add or delete your Notes, tap Edit on the top right of the screen. 3. Tap anywhere on your current Notes and then use the pop-up keyboard to edit, add or delete Notes and/or pictures. 4. After making your changes, tap Done on the pop-up keyboard or Save on the top right of the screen.
5. If you need to change your Insulin Name (the long-acting insulin you are using), tap your current Insulin Name to change it. • Scroll to your new long-acting insulin from the list and then tap Done. Cancel Done Basaglar Lantus • Tap Save when you are finished. Levemir Toujeo - If your new long-acting insulin requires a new Black Cap, you will be prompted to confirm you already have the Cap. Tap Yes, I Have My New Cap or Cancel to contact Customer Care for assistance.
Rapid-Acting Insulin View and edit your rapid-acting insulin information as needed. 1. Tap Insulin Settings on the My Settings screen. 2. Tap Rapid-Acting to display your current rapid-acting Insulin Name along with your Meal and Correction Insulin information. 3. To change your current Insulin Name, and remove, add or change your Meal or Correction Insulin, tap Edit on the top right of the screen.
• Follow the App prompts for entering new rapid-acting insulin information (see Entering Rapid-Acting Insulin Settings section in Chapter 5). • Tap Save on the Insulin Settings screen when finished. 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). CAUTION: Use MY SETTINGS in the App to update your insulin settings whenever your health care provider recommends changes.
6. To edit your Correction Insulin information you will need to do one of the following: • Remove Correction Insulin information previously entered and saved by tapping the edit icon ( ) next to the Correction Insulin section. This will completely remove current Correction Insulin information from your insulin settings. • Add Correction Insulin information by tapping + Add Correction Insulin.
- If your new rapid-acting insulin does not require a new White Cap, you will be prompted to review your new Insulin Name and Meal and Correction Insulin amounts. º Tap Review to display your updated insulin settings where you can change your Meal and Correction Insulin settings as needed. When you are finished, tap Save.
CAUTION: Make sure your phone is within communication range (within 20 ft) of your Caps after you make any changes to your insulin settings within the App. If your Caps do not have the most current settings, you could take too much or too little insulin, which may result in severe low or high glucose. 1. Follow the instructions on the App screens for sending rapid-acting insulin updates to your White Cap and wait for the confirmation screen and check mark ( ) to appear.
Accepting pending insulin updates Whenever you have made changes to insulin information in the App but have not yet sent them to your Caps, a Pending update outstanding banner will appear on the My Settings/Insulin Settings screens to remind you. This happens when you have made changes to insulin information but did not have your Cap available or it was not within communication range of your App.
4. If you accept the Pending update, pressing the button on the Black Cap to turn it on (within communication range of the App) will allow the update to be sent to the Cap. 5. Tap < Insulin Settings on the Pending Long-Acting Updates screen to return to the Insulin Settings screen. You may tap Edit to make new changes to your long-acting insulin information. 6.
Alerts The Alerts screen lets you set your App to prompt you when certain conditions occur that require your attention. These include: • 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. All Alerts are pre-set to “On” when you first begin using your App. Alerts will display, sound and vibrate on your App/phone.
Low Glucose Alert • The Low Glucose Alert is triggered when your Sensor glucose falls below 70 mg/dL. - 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. Sensor Unavailable Alert • The Sensor Unavailable Alert is triggered if there is a condition preventing the Sensor from sending an accurate glucose reading or glucose Alert to the App. - Slide the On/Off button to “On” or to “Off” to turn this Alert on or off.
Long-Acting Dose Alert • The Long-Acting Dose Alert is triggered when Bigfoot Unity thinks you have missed a long-acting insulin dose from your Black Cap. The pre-set duration time for this Alert is 25 hours. - Slide the On/Off button to “On” or to “Off” to turn this Alert on or off. 9:41 Alerts Long-Acting Dose Long-Acting Dose When on, this alert notifies you when the last dose recorded in the App was over <25> hours ago.
App Passcode Your Passcode keeps others from entering your App or making any changes to your App information without your permission. • Tap App Passcode on the My Settings screen. • Slide the On/Off button to “On” (pre-set is “Off”). • Enter your personal 4-digit Passcode on the Set Passcode pop-up screen. • Re-enter your Passcode on the Confirm Passcode pop-up screen. - Your Passcode is now set and required when you access the following sections in the App.
9 9 Care, Maintenance and Disposal of Bigfoot Unity 9.1 Living with your Bigfoot Unity™ Diabetes Management System Activity What to do Bathing, Showering, and Swimming Your Caps should not be used or carried when bathing, showering or swimming. Your Sensor is water-resistant and can be worn while bathing, showering, or swimming. Note: Do NOT take your Sensor deeper than three feet (one meter) or immerse it longer than 30 minutes in water. Sleeping Your Sensor should not interfere with your sleep.
Activity What to do Traveling by Air (continued) When traveling across time zones or between Standard and Daylight Saving Time, allow your phone to update the date and time automatically. 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.
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. Do not submerge, soak or wash the Cap. Make sure the USB port is dry before charging. Only use water, or isopropyl alcohol wipes for cleaning. The Caps have a mean use life of 2 years and have been validated for 156 cleaning cycles.
Cleaning and Disinfecting your Meter See the instructions that came with your Meter for cleaning and disinfecting. Additional information about the risks for transmitting bloodborne pathogens to persons undergoing fingerstick procedures for blood sampling can be found in the instructions that came with your Meter. 9.3 Pen Needles Refer to the instructions on your Bigfoot Unity Needles package for steps on inserting, storing and removing your pen needles. 9.
10 10 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 through the Customer Care page in the App or the company website (support.bigfootbiomedical.com). You can also reach Bigfoot Customer Care at (551) 244-3668. 10.1 Caps Usage Notifications Problem What it may mean “Active Insulin” is displayed on my White Cap.
Problem What it may mean Your Cap is off your rapid-acting or long-acting insulin pen. What to do Unless you are taking an insulin injection or replacing your insulin pen, you should keep your Caps on the pens at all times. When the Cap is left off the pen for more than 4 seconds, the timer will not re-set to 0 and start tracking your latest time since last dose until you re-insert your pen into the Cap. Problem What it may mean Your Cap has less than 25% battery power remaining.
Cap Display Issues Problem What it may mean Cap/Cap screen is unresponsive There is a problem with your Cap. You will not be able to use your Cap until the problem is resolved. What to do Press and hold the Cap button for about 20 seconds. If this does not resolve the problem, contact Bigfoot Customer Care at (551) 244-3668. Problem What it may mean Battery won’t charge Caps can no longer be used.
Pairing and Communication Problems Problem What it may mean Your White or Black Cap is unable to pair with the App. What to do Your App will also display a Pairing Error message. Check to see that the Bluetooth® setting is enabled on your phone and WiFi is turned on and follow the instructions in your App for pairing your App with your White or Black Caps. Make sure the devices are within communication range (within 20 ft), and the Caps wake up with a button press.
10.2 Sensor Scanning and Communication Problems Problem What it may mean Your White Cap is unable to scan your Sensor. What to do Try scanning again. Review instructions for proper scanning technique within this User Guide. Note: You may need to move away from potential sources of electromagnetic interference and try scanning again. Problem What it may mean The Sensor is still in its start-up period (within 60 minutes from first application).
Problem What it may mean There is a problem with your Sensor. What to do Replace your Sensor. Follow the instructions in your App for starting a new Sensor. Problem What it may mean Your Sensor was already started by another App. What to do Your Sensor can only be used with the App that started it. Scan the Sensor with the White Cap that was originally used with the App to start this Sensor. Or, apply and start a new Sensor. Problem What it may mean Your Sensor wear period (up to 14 days) has ended.
Problem What it may mean Your Sensor is too hot (above its normal operating range) to provide a glucose reading. What to do Try moving to an area with an ambient temperature of 50°F to 113°F (10°C to 45°C). Wait 10 minutes for your Sensor to reach the new temperature and begin sending glucose readings again. Problem What it may mean Your Sensor is too cold (below its normal operating range) to provide a glucose reading.
Low and High Sensor Glucose Messages On your White Cap for rapid-acting insulin, special messages will appear along with your Sensor reading/Trend Arrow when your Sensor glucose is low or high. A “Use Meter” message will also appear if it’s still within the first 12 hours after wearing the Sensor. Problem What it may mean Your scanned glucose result is low (< 70 mg/dL).
Problem What it may mean Your scanned glucose result is very low (< 40 mg/dL). or What to do Treat very low glucose according to your health care provider’s recommendations. Use your Meter to check and obtain a glucose value if it’s still within 12 hours of wearing your Sensor. Problem What it may mean Your scanned glucose result is very high (> 400 mg/dL). or What to do Treat very high glucose according to your health care provider’s recommendations.
Sensor Wear Problems Problem What it may mean Your Sensor is not sticking to your skin. The site is not free of dirt, oil, hair, or sweat. What to do Remove Sensor and shave and/or clean site with soap and water. Apply new Sensor following instructions in your App. Problem What it may mean Skin irritation at your Sensor application site. Seams or other constrictive clothing or accessories causing friction at the site. What to do Ensure that nothing rubs on the site.
10.3 Meter These Meter notifications apply to how your Meter works with Bigfoot Unity, and that might appear on your White Cap display. See the instructions that came with your Meter for a complete list of error messages that might appear on your Meter display. Problem What it may mean There is a problem with your Meter and you will not be able to have a blood glucose result sent to your White Cap. What to do Contact Bigfoot Customer Care at (551) 244-3668 to request a replacement Bigfoot Meter.
Problem What it may mean Your Meter glucose result is below 20 mg/dL. This low result may indicate hypoglycemia (low blood glucose). It also indicates that your result is below the Meter measuring range. What to do If you feel symptoms such as weakness, sweating, nervousness, headache or confusion, follow your health care provider’s recommendations to treat a low glucose. If you get a low blood glucose result but have no symptoms of low blood glucose, then re-check with a new test strip.
Problem What it may mean Your Meter is below its operating temperature range of 50°F to 104°F (10°C to 40°C). What to do See the instructions that came with your Meter. Try moving to an area with an ambient temperature of 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. Problem What it may mean Your Meter is above its operating temperature range of 50°F to 104°F (10°C to 40°C).
10.4 App Problem What it may mean Internet connection is not currently available. The App will not be able to respond to some of your actions. What to do Wait a few seconds and tap Try Again to see if an internet connection is re-established. Make sure your phone is connected to a wireless network, your phone is not in Airplane mode, and wireless communication is turned on. If you continue to have connection problems, call Bigfoot Customer Care at (551) 244-3668.
Problem What it may mean Your Sensor may not be applied properly. What to do Tap OK. Check if your Sensor may be loose. If it is, remove the Sensor and apply a new one. If it is applied properly, try starting the Sensor again with your Phone. If the problem persists, remove the Sensor and apply a new one. Problem What it may mean You may have already started the Sensor. What to do Try scanning the Senor again. If the problem persists, remove the Sensor and start a new one.
Problem What it may mean MY HISTORY records in your App indicate you injected an insulin dose but you did not Your insulin pen may have accidentally separated from your Cap and you may (or may not) have been aware of it at the time. In either case, your App and Cap would record that you injected an insulin dose (even if you did not), and that record would appear in MY HISTORY.
Problem What it may mean You are not receiving Low Glucose, Sensor Unavailable or Missed LongActing Dose Alerts. Your Bigfoot Unity is not set up correctly to receive Notifications and Alerts, or there is a communication problem between some of the devices.
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. The tables that follow let you know when to expect certain Notifications and Alerts and what to do.
Notification What it may mean Your Sensor glucose is low (between 55 mg/dL and 69 mg/dL). What to do An Alert will follow this Notification. Follow the steps for what to do in the Alerts section that follows. Notification What it may mean Your Sensor glucose is at the low end of the pre-set target range (between 70 mg/dL and 99 mg/dL). What to do Monitor your glucose with your Sensor or Meter to make sure it is not going low.
Notification What it may mean Your Sensor glucose is at the high end of the Bigfoot Unity pre-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 range. Notification What it may mean Your Sensor glucose is high (above 250 mg/dL). What to do Monitor your glucose with your Sensor or Meter.
Notification What it may mean Your Sensor is not yet ready to send glucose readings and generate alerts to your App/phone, but should be ready in the indicated period of time. What to do Wait the indicated period of time for the Sensor to start sending glucose readings and alerts to your App/phone. Notification What it may mean Your Sensor is not able to send glucose readings or generate alerts to your App/ phone. What to do There is a problem with your Sensor that will not resolve itself.
A.2 Alerts All Alerts may be turned on or off as needed. When turned on, alerts will initially vibrate and will sound later if you do not respond. Glucose Alerts Alert What it may mean Low Glucose Treat low glucose and monitor. Your Sensor glucose is low (< 70 mg/dL). Glucose less than 70 mg/dL. 12 minutes ago OK What to do Tap OK to acknowledge Alert. Scan your Sensor or measure your blood glucose, and treat low glucose according to your health care provider’s recommendations.
Alert What it may mean Sensor Unavailable No glucose alerts available. Sensor too hot to provide a glucose reading. Move to a location where the temperature is appropriate, and Sensor glucose should return in a few minutes. The Sensor is too hot to communicate with your App/phone. No glucose alerts can be sent without communication. 12 minutes ago OK What to do Tap OK to acknowledge Alert. Try moving to an area where the temperature is within the allowable range for your Sensor.
Alert What it may mean The Sensor is temporarily unable to communicate with your App/phone. No glucose alerts can be sent without communication. What to do Tap OK to acknowledge Alert. The communication problem should resolve itself in a few minutes. Initial Alert will not repeat but new Alert will be triggered up until Sensor is able to communicate with App/phone. At that time, glucose alerts will resume. If you do not tap OK, Alert will repeat every five minutes.
Alert What it may mean The Sensor needs more time to adjust to your body before it can begin sending glucose readings to your App/phone. No glucose alerts can be sent until the Sensor begins sending glucose readings to your App/phone. What to do Tap OK to acknowledge Alert. Wait a few minutes to see if the Sensor starts communicating with the App/phone. Initial Alert will not repeat but new Alert will be triggered up until Sensor is able to communicate with and send glucose readings to your App/phone.
Alert What it may mean The Sensor’s (up to) 14-day wear period has ended. No glucose alerts can be sent until the new Sensor begins sending glucose readings to your App/phone. What to do Tap OK to acknowledge Alert. Initial Alert will not repeat but new Alert will be triggered up until you replace the Sensor. You will need to apply and start a new Sensor and wait for Sensor to begin sending glucose readings to your App/phone. At that time, glucose alerts will resume.
Appendix B:Settings Settingsfor forBigfoot Bigfoot Unity App Appendix B: Unity App Information to Enter in the App CAUTION: Bigfoot Unity does not support insulin doses in half-unit increments. Long-Acting Insulin of long-acting insulin B.1Name Information to Enter in the App Long-acting once a day dose units Long-Acting Insulin Note :: Certain insulin pens deliver doses in 2-unit increments.
Rapid-acting for meals Option insulin C optional Correction Insulin (to bring down a high glucose) Carb Amounts grams unitsoptional of rapid-acting Choose one approach from below 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.
Appendix C: Technical Information C.
Do NOT re-use MRI unsafe FCC Declaration of Conformity mark Not made with natural rubber latex Warnings and Cautions Sterilized using radiation Humidity limitation Do NOT use if package is damaged CAUTION: Federal law restricts this device to sale by or on the order of a physician. 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.
C.2 Sensor Specifications Sensor glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 40 to 400 mg/dL Sensor size 0.19 in height and 1.38 in diameter (5 mm in height and 35 mm diameter) Sensor weight 0.18 oz (5 grams) Sensor power source One silver oxide battery Sensor data Up to 14 days Sensor memory 8 hours (glucose readings stored every 15 minutes) Sensor transmission range 20 feet (six meters) unobstructed Operating temperature 50 °F to 113 °F (10.
C.3 Cap Specifications Dimensions 108 mm X 24 mm X 28 mm Weight Less than 1.4 oz (40 g) without insulin pen Power supply Rechargeable lithium ion battery - not replaceable Operating voltage 3.
Transport and Storage Between Use Temperature range -13 °F to 158 °F (-25 °C to 70 °C) Relative humidity range up to 90%, non-condensing Atmospheric pressure range 700 hPa to 1,060 hPa Altitude range -1,250 ft to +10,000 ft (-381 m to +3,048 m) C.4 Communications Specifications Cap and Phone Communication Compatible Phones iPhone 7 and later; for full list visit www.bigfootbiomedical.com/compatible NFC scan distance 1.0 cm Radio Frequency Near Field Communication (13.56 MHz RFID); 2.402 to 2.
C.7 Security Measures The communication between the White Cap and Sensor during a scan is a short range Near Field Communication (NFC) method which makes it difficult to interfere with or intercept during transmission. The transmitted data is protected by a proprietary data format, encryption, and memory map. The integrity of transmitted data is ensured by a cyclic redundancy check (CRC) generated by the Sensor and verified by the White Cap.
C.10 Performance Characteristics of the FreeStyle Libre 2 Flash Glucose Monitoring System* Overview of Clinical Studies Two studies were conducted in the United States (US) to evaluate the performance, safety, effectiveness, and precision of the FreeStyle Libre 2 Flash Glucose Monitoring System (System). One study included adults (Adult study) and the other study included children (Pediatric study). All subjects in both studies required insulin to manage their diabetes.
Accuracy Accuracy of the System was measured by comparing paired continuous glucose monitoring (CGM) and YSI blood glucose values. The percentage of total System readings that were within 20 mg/dL for YSI blood glucose values < 70 mg/dL or 20% of YSI for blood glucose values ≥ 70 mg/dL is displayed in Table 1a. The Mean Absolute Relative Difference (MARD) gives an indication of the average percent disagreement between the CGM and the reference. For example, in the Adult study, 92.
Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144) CGM Number Percent Percent Percent Percent Glucose of CGM- Within Within Within Within Level† Reference ±15 ±20 ±40 ±15% (mg/dL) Pairs mg/dL mg/dL mg/dL Percent Within ±20% Percent Within ±40% Mean MARD bias (%) (mg/dL) <54 518 85.9 93.8 99.4 -6.4 13.8 54-69 3012 89.5 94.2 99.1 -3.3 10.8 70-180 7785 76.5 86.6 99.2 -4.8 10.6 181-250 3037 89.1 95.0 99.9 -10.1 7.8 >250 4383 94.0 97.9 100.0 -6.3 6.
Table 1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric; n=86) CGM Number Percent Percent Percent Percent Glucose of CGM- Within Within Within Within Level Reference ±15 ±20 ±40 ±15% (mg/dL) Pairs mg/dL mg/dL mg/dL Percent Within ±20% Percent Within ±40% Mean MARD bias (%) (mg/dL) <54 117 94.0 98.3 100.0 6.7 14.6 54-69 670 96.1 98.7 100.0 0.9 9.5 70-180 2001 73.3 83.3 97.7 -4.5 11.7 181-250 806 87.5 92.9 98.6 -6.0 8.3 >250 1492 91.1 98.1 99.9 -12.8 7.
Table 2b: Concurrence Analysis with ‘< 40 mg/dL’ CGM Reading (Pediatric; n=86) CGM-Reference Pairs n Cumulative % YSI (mg/dL) N <50 <60 <70 <80 ≥80 0 1 2 2 0 0.0 50.0 100.0 100.0 0.0 2 Tables 2c and 2d display the concurrence between the CGM and YSI reference glucose when CGM reads ‘> 400 mg/dL’. In the Adult study, when CGM reading was ‘> 400 mg/dL’, YSI glucose values were above 350 mg/dL 97.5% of the time, above 300 mg/dL 100.0% of the time, above 250 mg/dL 100.
Concurrence of System and Reference (CGM vs. YSI) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented for each CGM range in Tables 3a and 3b and for each YSI range in Tables 3c and 3d. For example, in the Adult study, when the System glucose readings were within the 81 to 120 mg/dL range, actual blood glucose values were between 40 and 60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 11.0% of the time, between 81 and 120 mg/dL 70.
Table 3b: Concurrence Analysis by CGM Glucose Level (Pediatric; n=86) CGM Glucose Level (mg/dL) <40 40-60 61-80 <40† . 50.0 40-60 0.6 61-80 81-120 121160 161200 201250 251300 301350 351400 >400† † YSI Glucose Level (mg/dL) N 81120 121160 161200 201250 251300 301350 351400 >400 50.0 . . . . . . . . 2 47.7 42.9 8.1 0.6 . . . . . . 480 . 13.1 61.2 23.8 1.8 . . . . . . 776 . 0.3 12.0 68.7 17.5 1.4 0.1 . . . . 798 . . . 10.6 70.0 17.3 2.1 . .
Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144) YSI Glucose Level † (mg/dL) <40 40-60 61-80 CGM Glucose Level (mg/dL) 81120 121160 161200 201250 251300 301350 351>400† 400 N <40 12.5 87.5 . . . . . . . . . 8 40-60 0.1 62.9 36.6 0.4 . . . . . . . 1591 61-80 0.1 26.4 62.6 10.8 0.1 . . . . . . 3093 81-120 0.0 2.1 18.8 71.7 7.3 . . . . . . 2971 . . 0.5 22.3 69.6 7.7 . . . . . 2418 . 0.1 0.1 1.5 26.9 62.5 9.0 0.
Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric; n=86) YSI Glucose Level † (mg/dL) <40 40-60 61-80 <40 CGM Glucose Level (mg/dL) 81120 121160 161200 201250 251300 301350 351>400† 400 N . 100.0 . . . . . . . . . 3 40-60 0.3 68.6 30.5 0.6 . . . . . . . 334 61-80 0.1 26.5 61.1 12.3 . . . . . . . 778 81-120 . 4.7 22.2 65.7 7.3 0.1 . . . . . 834 . 0.5 2.2 22.1 63.8 11.4 . . . . . 633 . . . 2.5 23.0 60.7 13.3 . . 0.
Glucose Rate of Change Accuracy The System’s glucose rate of change (ROC) accuracy, as assessed by concurrence analysis, is presented in Tables 4a and 4b. For example, in the Adult study, when the Sensor glucose ROC indicated that glucose was changing slowly downward (-1 to 0 mg/dL/min ( )), actual glucose levels in the body were falling quickly (<-2 mg/dL/min) 1.2% of the time, falling (-2 to -1 mg/dL/min) 8.3% of the time, changing slowly downward (-1 to 0 mg/dL/min ) 67.
Alert Performance The tables in this section show the accuracy of the System’s Low Glucose Alert. The Alert Rate tells you how often the alert is right or wrong. The Detection Rate tells you how often the System is able to recognize and notify you about a low glucose event.
Table 5a: Low Glucose Alert Performance (Adult; n=144) Low Glucose Alert level (mg/dL) 70 Alert Rate Detection Rate Number of Events (n) True Alert Rate (%) False Alert Rate (%) Number of Events (n) Correct Detection Rate (%) Missed Detection Rate (%) 21504 86.0 14.0 3652 89.3 10.
Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric; n=86) Number of CGM-reference pairs MARD (%) Within ±15% / ±15 mg/dL Within ±20% / ±20 mg/dL Within ±40% / ±40 mg/dL Beginning 1403 10.9 79.3 88.0 98.2 Early Middle 1307 8.0 90.0 94.3 98.2 Late Middle 1068 9.8 84.1 92.6 99.8 End 1308 10.2 83.9 91.8 99.4 Wear Period Sensor Wear Duration The Sensor can be worn for up to 14 days.
Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146) Day of Wear Number of Sensors Survival Rate (%) 1 145 99.3 2 142 97.3 3 140 95.9 4 137 93.8 5 134 91.8 6 133 91.1 7 132 90.4 8 127 87.0 9 123 84.9 10 119 82.2 11 112 77.3 12 111 76.6 13 104 71.8 14 100 71.1 Table 7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=87) Day of Wear Number of Sensors Survival Rate (%) 1 85 97.7 2 84 96.6 3 83 95.4 4 82 94.3 5 82 94.3 6 82 94.
Glucose Reading Availability The System is designed to show a Sensor glucose reading after each scan that is performed throughout the wear period after the start-up time. Tables 8a and 8b show the glucose reading capture rate for each day of the wear duration. Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146) 176 Day of Wear Number of Sensors Capture Rate (%) 1 146 98.3 2 145 98.1 3 143 98.3 4 140 98.3 5 138 98.4 6 135 98.3 7 134 98.4 8 131 98.
Table 8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=87) Day of Wear Number of Sensors Capture Rate (%) 1 87 95.4 2 85 95.2 3 84 95.6 4 82 95.7 5 83 95.9 6 82 96.1 7 83 96.5 8 82 96.8 9 81 96.9 10 78 96.9 11 78 96.9 12 76 97.1 13 75 97.1 14 74 97.
Precision Precision of the System was evaluated by comparing the results from two separate Sensors worn on the same subject at the same time. Table 9a provides data from 146 subjects in the Adult study; Table 9b provides data from 86 subjects in the Pediatric study. For adults, the paired absolute relative difference (PARD) between the two Sensors was 8.1% with coefficient of variation (CV) of 5.7%. For children ages 12-17, PARD was 8.4% with CV of 6.0%.
Adverse Events No device related serious adverse events occurred during the studies. In the Adult study, mild skin irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion site and adhesive area by a small number of subjects (10 out of 146 or 6.8%). Pain was mostly reported as none with only one instance of mild pain.
C.11 Electromagnetic Compatibility (EMC) Bigfoot Unity has been tested and found to be appropriate for use at home. In most cases, Bigfoot Unity should not interfere with other home electronic devices if used as instructed. However, the Caps, Sensor, Meter, and your phone give off radio frequency (RF) energy. The low level of RF energy emitted by the system is not likely to cause interference in nearby electronic equipment.
FCC Compliance The Bigfoot Unity System complies with Part 15 of the Federal Communications Commission (FCC) rules that state the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
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 test level Electrostatic discharge ±8 kV contact (ESD) ±15 kV air IEC 61000-4-2 ±2 kV for power supply lines ±2 kV for power supply lines Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile.
Immunity test RFID Magnetic Immunity AIM 7351731: 2017 test level ≥65 A/m 134.2kHz ≥7.5A/m 13.56MHz Performance Equipment operating in the 13.56 MHz frequency range in the vicinity of the RCAP was found to have a temporary effect on the scanning functionality of the Sensor. After removing the source of interference, the scanning function resumed with no degradation of performance. Equipment operating in the 134.2 kHz frequency range had no effect on the scanning function.
Recommended separation distances between portable and mobile RF communications equipment and Bigfoot Unity Bigfoot Unity is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Bigfoot Unity can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Bigfoot Unity.
Index A Accepting updates 110, 118 Active alerts icon Active Insulin 97 78, 85, 87, 128 Add Notes 42, 111 Add Photos 43 45, 46, 99, 120 Alerts App create an account 31 download 31 Home screen 97, 145 settings 32, 110 setup 33 Applying Sensor 24, 57, 93 Arrows glucose trend 76 B Backup diabetes management plan Black Cap 18, 20, 88, 104, 138 48, 65, 107 Blood glucose 25, 77 checking 77 Meter 20, 54 C Caps changing 47, 106, 107 charging 88 cleaning 126 messages Active Insuli
Glucose Trend Arrow 76 Going Low 76, 135 Low Glucose 76, 135 Meal 79 Meal + Correction 79, 130 Time Since Last Dose Use Meter 72, 74 20, 60, 76, 84, 91, 128, 135 replacing 47, 106, 107 updating 47, 106, 107 74 viewing glucose information viewing insulin information 42, 69 Check blood glucose 77 Cleaning Meter 127 Computed tomography (CT) 18 Considerations if You Record a Dose You Did Not Take 87 Correction dose table 37, 41 Correction factor 37, 41 Correction insulin 37, 78 C
F Flag dose as not taken 88, 104 G Glucose check blood 77 Going Low 76, 135 Low 76, 135 managing 14 ranges 98 scan Sensor 59, 75, 83, 95 target 37, 41 trend arrow 76 Graph view 102 H Help and support 123 History 102 Home screen Active Alerts icon 97 main menu options 101 Notifications/Alerts Off icon 97, 98 Hyperglycemia 139 Hypoglycemia 11, 139 I Icons/ symbols 11, 156 Insulin changing 47 correction/correction dose 41, 78, 79 correction dose table 37 correction fac
meal/mealtime dose 34, 35, 79 pens rapid-acting 28, 127 34, 74, 85, 113 settings 33, 44, 110 L List view 103 Long-acting insulin 33, 111 Low Glucose 76, 135 M Magnetic resonance imaging (MRI) 18 Making treatment decisions 82 Making updates to settings 111 Meal dose label Meal/Mealtime Insulin Messages Meter 34 34, 35, 79 101, 145 20, 54, 108 Meter (Status and Start a New Meter) 108 MY DEVICES 105 MY HISTORY 102 MY SETTINGS 110 N Notes 42, 111 Notifications Notifications/Alerts
R Rapid-acting insulin Removing Sensor 33, 85, 113 25, 92, 95, 125 Restore App settings 109 Reviewing history 102 S Scan Sensor 59, 75, 83, 95 Send settings from App to Caps 50, 52, 116 Send settings later 117 Sensor application first 12 hours of use removal 25, 57, 93 60, 76, 84, 91, 95, 105 25, 92, 95, 125 start-up period 60, 95 unavailable 121 Settings App 32, 110 insulin 44 phone 45, 98 updates 111 Start Black Cap 48, 107 Start Caps 48, 51, 105 Start Meter 54, 108 Start S
U Use Meter 20, 60, 76, 128, 135 V Viewing glucose information on Caps 74 Viewing insulin information on Caps 42 W White Cap 190 51, 64, 74, 106 The Bigfoot Unity™ Diabetes Management System User Guide
Bigfoot Biomedical, Inc. Milpitas, CA 95035 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 and Libre are trademarks of Abbott Diabetes Care, Inc. All insulin brand names are trademarks of their respective holders. Emergen-C is a trademark of Pfizer, Inc. Airborne is a trademark of Reckitt Benckiser.