Bigfoot Biomedical Bigfoot Unity System User'S Manual Download Page 9

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The Bigfoot Unity

™

Diabetes Management System User Guide

Appendix B: Settings for Bigfoot Unity App

B.1 Information to Enter in the App

Appendix C: Technical Information

C.1 Labeling Symbols

161

C.2 Sensor Specifications

163

C.3 Cap Specifications

164

C.4 Communications Specifications

165

C.5 Bigfoot Unity™ Diabetes Management

System Specifications

165

C.6 Kit Specifications

165

C.7 Security Measures

166

C.8 Quality of Service (QoS)

166

C.9 Meter Specifications

166

C.10 Performance Characteristics of the FreeStyle

Libre 2 Flash Glucose Monitoring Sensor

167

Overview of Clinical Studies

167

Adverse Events

184

C.11 Electromagnetic Compatibility (EMC)

185

FCC Compliance

186

Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions

187

Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity

188

Recommended Separation Distances between
Portable and Mobile RF Communications
Equipment and Bigfoot Unity

Summary of Contents for Bigfoot Unity

Page 1: ...SYSTEM USER GUIDE...

Page 2: ......

Page 3: ...lin dose The System offers a suite of tools to help you streamline your diabetes care using two Bigfoot Unity Caps Caps with digital displays that replace the pen caps from your disposable long acting...

Page 4: ...iew 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 5 Monitoring Glucose with the Sensor 14 2 6 Monitoring Glucose with the...

Page 5: ...foot Unity 30 5 2 Download the App and Create an Account 30 5 3 Enter Settings 31 Enter Insulin Settings 32 Entering Long Acting Insulin Settings 32 Entering Rapid Acting Insulin Settings 33 Entering...

Page 6: ...cking Blood Glucose with the Meter 77 Viewing Correction Dose Amount on the White Cap 78 Viewing Meal Dose Amounts on the White Cap 79 Viewing Meal Correction Dose Amounts on the White Cap 79 6 3 Usin...

Page 7: ...Not Taken 106 8 3 MY DEVICES Status and Starting New Devices 107 Sensor Status and Start a New Sensor 107 White Cap Status and Start a New White Cap 108 Black Cap Status and Start a New Black Cap 109...

Page 8: ...posal 130 10 Troubleshooting 10 1 Caps 131 Usage Notifications 131 Cap Display Issues 133 Pairing and Communication Problems 134 10 2 Sensor 135 Scanning and Communication Problems 135 Low and High Se...

Page 9: ...ions 165 C 6 Kit Specifications 165 C 7 Security Measures 166 C 8 Quality of Service QoS 166 C 9 Meter Specifications 166 C 10 Performance Characteristics of the FreeStyle Libre 2 Flash Glucose Monito...

Page 10: ...bile phone and create an account You will use the App to set up Bigfoot Unity and get started 1 1 Abbreviations and Conventions Used Throughout this User Guide the App and Cap Displays App Software Ap...

Page 11: ...ngs 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 Ca...

Page 12: ...gfoot Unity and what to do if you need help Bigfoot Unity is available only with a prescription in the U S 2 2 The Bigfoot Unity App The App guides you through entering your insulin settings connectin...

Page 13: ...on your rapid acting insulin pen The timer on the White Cap also helps you remember when you took your last dose of rapid acting insulin from your pen The White Cap works with the FreeStyle Libre 2 Se...

Page 14: ...rends in history may help you with your diabetes self care Behind the scenes your App is also continuously monitoring your Sensor readings and can alert you on your phone if your glucose level is low...

Page 15: ...vice 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 b...

Page 16: ...nded for single patient use only and requires a prescription Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therap...

Page 17: ...your glucose levels require your immediate attention Glucose alerts are an important safety feature for some people for example those that have impaired awareness of hypoglycemia or a history of seve...

Page 18: ...an resume using Bigfoot Unity You will still be able to use your insulin pens without the Caps App Sensor or Meter Consult with your health care provider about a backup glucose monitoring and insulin...

Page 19: ...oot Unity Components WARNINGS Use your blood glucose meter to make diabetes treatment decisions when you see Use Meter on the White Cap during the first 12 hours of wearing a Sensor if your Sensor glu...

Page 20: ...lin without using Bigfoot Unity make sure you keep track of the time you took insulin and check your glucose frequently Allowing time for the insulin to work prior to taking another dose can help prev...

Page 21: ...tment 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 t...

Page 22: ...Critical Alerts are not turned on You can only use the App for 4 hours after Critical Alerts are turned off You must allow Notifications for the Bigfoot Unity App to receive Bigfoot Unity Alerts on yo...

Page 23: ...ng 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 The Sensor can be worn for up to 14 days Remember to always h...

Page 24: ...he wear period 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 expos...

Page 25: ...ensor 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 a...

Page 26: ...Customer Care at 551 244 3668 If you believe your glucose readings are not correct or are inconsistent with how you feel perform a blood glucose test on your finger to confirm your glucose If the prob...

Page 27: ...sor Kit 2 each containing Sensor Pack Sensor Applicator Alcohol Wipe Product Insert A E F D G H B C 4 1 Working with Your Health Care Provider To get started using the Bigfoot Unity Diabetes Managemen...

Page 28: ...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 Insul...

Page 29: ...Compatible Mobile Phones and iOS The App works on your compatible personal mobile phone Visit www bigfootbiomedical com compatible for the current list of compatible phones and iOS versions Check the...

Page 30: ...e you launch the App you will start at the beginning of the section you had not finished Note that many App Setup screens have the option to 1 tap Back on the top left of the screen to return to the p...

Page 31: ...address Your App account is now set up and ready for use Simply tap the App icon on your phone whenever you want to launch the App After logging in the App will prompt you to accept the terms of use a...

Page 32: ...s screen 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 fi...

Page 33: ...ommended tap 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 d...

Page 34: ...ing insulin you take for each type of meal Three Specific Carb Amounts Based on how the amount of carbohydrates in meals you commonly eat affect your glucose In this category pick three different carb...

Page 35: ...d scroll to the insulin units 0 to 80 you typically take to cover that number of grams of carbohydrate amount and tap Done when you are finished Repeat for your two other Carb Amounts Tap Next when yo...

Page 36: ...ed units of rapid acting insulin to bring down a high glucose in this range For example your table might include six glucose ranges and you will enter the rapid acting insulin associated with each ran...

Page 37: ...nd 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 The App and White Cap use this table to determine the gluco...

Page 38: ...cally 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 f...

Page 39: ...he units of Insulin for each range below Need help Correction Insulin 1 3 2 4 5 6 Next Insulin Settings 2 Enter the desired units 0 to 40 by scrolling through the units for that range and then tap Don...

Page 40: ...on 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...

Page 41: ...d until the upper range of a row exceeds 400 mg dL One additional insulin unit is added to each row to represent approximately how much insulin would be needed to bring your current glucose level down...

Page 42: ...and photos Tap Allow to allow Access can be changed in your phone settings 3 Decide if you want to add a previously taken photo or take a new photo To take a new photo tap the camera icon and then use...

Page 43: ...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 u...

Page 44: ...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...

Page 45: ...low or that your Sensor glucose information is not available when your phone is muted or set to Do Not Disturb Your App will indicate if Critical Alerts are not turned on You can only use the App for...

Page 46: ...Sensor and Caps You must keep your phone and App Bluetooth settings turned on for Bigfoot Unity to work properly and to get Low Glucose Sensor Unavailable and Long Acting Dose Alerts Critical Alerts Y...

Page 47: ...ot receive glucose information from the Sensor you may not know if you have low or high glucose Your App will indicate if Bluetooth is not turned on You can only use the App for 4 hours after Bluetoot...

Page 48: ...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 1 Tap Set...

Page 49: ...e App will remind you if the Bluetooth setting is not turned on Bluetooth communication is automatically enabled in your Black Cap whenever you turn it on 4 Press the Black Cap button once to turn it...

Page 50: ...ff before pairing is complete press the Black 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...

Page 51: ...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 p...

Page 52: ...App will automatically search for and display the Serial Numbers of any White Caps it finds within range 5 Tap the Serial Number on the App screen that matches the Serial Number on the back of your W...

Page 53: ...n t match tap No the insulin names don t match You will be prompted to edit the rapid acting insulin names you previously entered Tap Yes Edit to go back and enter a new rapid acting Insulin Name Tap...

Page 54: ...ur White Cap to the Meter supplied by Bigfoot Biomedical 1 Tap Start Meter 2 Tap Next 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: ...g for your Meter The App will automatically search for and pair with the first Meter it finds within range If there is a connection error bring the Meter to within 12 inches of the White Cap wait for...

Page 56: ...played A check mark will indicate that the Start Meter section is complete 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...

Page 57: ...or 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 3 Apply a Sensor to the back of your upper arm see C...

Page 58: ...g 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 t...

Page 59: ...r 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...

Page 60: ...Meter message Whenever Use Meter is displayed on the White Cap check your blood glucose with your Meter to confirm the Sensor reading prior to treatment 11 Tap OK to continue You will go back to the S...

Page 61: ...e 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 U...

Page 62: ...lucose 2 Tap the play button to start watching a short video clip 3 When done watching tap Next to begin displaying a series of Knowledge Review screens You can rewatch the video by tapping Watch Agai...

Page 63: ...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 w...

Page 64: ...sing the White Cap 2 Tap the play button to watch a short video clip 3 When done watching tap Next to begin displaying a series of Knowledge Review screens You can rewatch the video by tapping Watch A...

Page 65: ...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...

Page 66: ...screen to continue to the next one After tapping Next on the last Knowledge Review screen you will be prompted to check your knowledge 6 Follow the series of screen prompts to answer the Knowledge Ch...

Page 67: ...om 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 Important Reminders 1 Tap Importan...

Page 68: ...Bigfoot Unity Diabetes Management System User Guide Chapter 5 4 After tapping Next on the last practice screen Customer Care information will be displayed Tap Done Congratulations on completing the Ap...

Page 69: ...will need to charge the Caps according to the instructions later in this chapter 6 1 Pairing the Black and White Caps If this is the first time connecting your Caps with the App the devices will need...

Page 70: ...e stored data every 10 minutes The Cap will display an Attempting To Communicate icon if there is information waiting to be sent When changes are made to your long action and or rapid acting insulin d...

Page 71: ...n the pen Bigfoot Unity thinks you took a dose of insulin and re starts counting the time since last dose Example Insertion of insulin pens into Caps It is important to always put the Caps back on you...

Page 72: ...lack Cap 3 Continuing from the previous steps for viewing the time since last dose press the Black Cap button again to display the Daily Dose of long acting insulin that you and your health care provi...

Page 73: ...you took insulin and check your glucose frequently Allowing time for the insulin to work prior to taking another dose can help prevent severe low glucose Note Your Black Cap is not used to communicate...

Page 74: ...high blood glucose and or cover carbs in a meal or snack Note If this is the first time using the White Cap to track your last insulin dose the screen will show dashes in place of the hours and minute...

Page 75: ...eadings IMPORTANT A maximum of 8 hours of glucose data is stored in the Sensor To avoid gaps missing data in your Sensor glucose history graph it is important to scan your Sensor with your White Cap a...

Page 76: ...nd 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...

Page 77: ...tip using appropriate lancing device and apply to the end of the strip 3 Turn the White Cap on by pressing the button one time to display the Time Since Last Dose screen and be prompted to Scan or che...

Page 78: ...te Cap is used to provide the Correction Insulin dose recommendation The Trend Arrow is not used in the dose recommendation Speak with your health care provider for advice on how best to utilize the a...

Page 79: ...for viewing mealtime insulin units press the White Cap button once to continue 6 View your Total Mealtime Correction Insulin Units If Mealtime and Correction Insulin were entered in the App and the f...

Page 80: ...d then display your rapid acting insulin name WARNINGS Always check that the insulin name displayed on the Cap matches the name on the insulin pen you intend to use before making a diabetes treatment...

Page 81: ...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 qu...

Page 82: ...nt decisions when 1 Sensor data is not available 2 when you see the words Use Meter on the White Cap or 3 if your Sensor glucose reading does not match how you feel Using your Meter will provide you w...

Page 83: ...just mean taking insulin Treatment decisions can also include things like taking fast acting carbs eating or even waiting and scanning again later Your health care provider can also help you to under...

Page 84: ...forgot to take insulin before eating you would expect your glucose to be high If your glucose reading is low then it doesn t match your recent activity so don t use it to make treatment decisions Don...

Page 85: ...eatment decision For example if your glucose is high and going up your first instinct may be to take more insulin to lower your glucose however depending on when you last took insulin or your recent a...

Page 86: ...avoid insulin stacking Bedtime How often do you check your glucose before bed What do you consider a safe bedtime glucose When should you eat a bedtime snack What do you do if your before bedtime glu...

Page 87: ...reen will display Active Insulin instead of giving you a suggested correction dose If your glucose is high you will need to use a backup method to determine if a correction dose is needed Three hours...

Page 88: ...le to use the Caps until you are done charging 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...

Page 89: ...on 1 Connect the small end of the USB cable to either Cap and the other end to the power adapter Then plug the power adapter into a wall outlet The display will show that the Cap is charging 2 Wait ab...

Page 90: ...Unity Diabetes Management System User Guide Chapter 6 Battery States Battery symbols What it means No power remaining Charge Cap immediately 25 or lower Charge Cap 50 75 100 Cap is charging charging c...

Page 91: ...end Arrow will appear on your Cap display and the past 8 hours of your glucose data will be stored in your App where you are able to track and look for trends in your data IMPORTANT A maximum of 8 hou...

Page 92: ...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 Sens...

Page 93: ...r Sensor if it starts to loosen and follow the instructions to select an appropriate application site Do not attempt to reinsert the Sensor Contact Bigfoot Customer Care at 551 244 3668 if your Sensor...

Page 94: ...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 Note The area MUST be clean and dry fo...

Page 95: ...your body CAUTION Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury 8 Gently pull the Sensor Applicator away from your body The Sensor s...

Page 96: ...ew 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 a...

Page 97: ...Check to make sure your Sensor has not come loose If it has come loose remove it and apply a new one and contact Bigfoot Customer Care at 551 244 3668 1 Pull up the edge of the adhesive that keeps yo...

Page 98: ...ll receive information about your Sensor glucose reading and range and the status of your Sensor It s also where you will receive Notifications and Alerts The bottom of the Home screen displays the th...

Page 99: ...the screen to adjust your phone settings Optimal Phone Settings Bluetooth settings are On Critical Alerts are On Notifications are On Sounds for Notifications are On Lock Screen and Banners are On Do...

Page 100: ...glucose information is not available when your phone is muted or set to Do Not Disturb Your App will indicate if Critical Alerts are not turned on You can only use the App for 4 hours after Critical...

Page 101: ...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 Alerts may also display on a compatible watch dependi...

Page 102: ...ere low or high glucose 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 recei...

Page 103: ...fications Alerts and Home screen glucose ranges that might occur and suggestions for what to do Home Screen Glucose Ranges The Home screen is where your glucose range or information about your Sensor...

Page 104: ...ph View screen includes Glucose data from your Sensor over the past 12 to 48 hours graphed as a trend line ending with the most current glucose reading on the far right Tap the graph at any glucose da...

Page 105: ...n the past 3 hours the White Cap will display Active Insulin and will not display a correction dose This is because the last dose may be still working to bring down your glucose Taking another insulin...

Page 106: ...f you flag the dose as not taken If your glucose is high you will need to use a backup method to determine if a correction dose is needed The Black Cap will re set the timer after it records a dose ev...

Page 107: ...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 You will also need to pair the new Caps with the other Bigfoot Uni...

Page 108: ...urn to the White Cap device screen if you do not want to proceed 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 st...

Page 109: ...icated with your Black Cap 1 Tap Start New Black Cap to start a new Black Cap 2 You will be prompted to have your new Black Cap ready Tap Yes I have my new Cap to continue If you don t have your new B...

Page 110: ...eplace 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 pai...

Page 111: ...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 in...

Page 112: ...d software Logout of your App account Insulin Settings In Insulin Settings you can make updates to the information you and or your health care provider entered during App Setup As long as the Caps are...

Page 113: ...settings Long Acting Insulin View and edit your long acting insulin information as needed 1 Tap Insulin Settings on the My Settings screen 2 Tap Long Acting to display your current long acting Insuli...

Page 114: ...your long acting insulin settings Then proceed to pair your new Black Cap with your App and send updated long acting insulin settings to the Black Cap If your new long acting insulin does not require...

Page 115: ...nsulin settings At any point you can tap Erase all settings and start over to start with a clean slate 4 If you choose to start over tap Erase all settings and start over You will be prompted to confi...

Page 116: ...id Acting Insulin Settings section in Chapter 5 Change Meal Insulin information previously entered and saved by first tapping the edit icon next to the Meal Insulin section to completely remove the in...

Page 117: ...ings section in Chapter 5 If you need to make edits to your Insulin Name go to Step 7 that follows If you are done making edits to your Rapid Acting Insulin Settings tap Save Then follow the App promp...

Page 118: ...nsulin settings where you can change your Meal and Correction Insulin settings as needed When you are finished tap Save Then follow the App prompts for turning the White Cap on and sending updated rap...

Page 119: ...and under Insulin Settings there will be an Update Pending note If you try to edit and save insulin settings but have previously pending updates to your long acting or rapid acting insulin Mealtime In...

Page 120: ...not have your Cap available or it was not within communication range of your App Note If you have a Pending update and wake up your Cap by pressing the button within communication range of the App the...

Page 121: ...dates to your rapid acting insulin confirm the changes to the Insulin Name Meal Insulin and Correction Insulin on the Pending Rapid Acting Updates screen You can toggle between current and pending set...

Page 122: ...sor status If you did not Allow this feature when first setting up the App the App will indicate that Critical Alerts are turned off You can only use the App for 4 hours after Critical Alerts have bee...

Page 123: ...m 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 Tap Alerts to return to the Alerts screen Low Glucose Alert The L...

Page 124: ...My Settings screen Slide the On Off button to On pre set is Off Enter your personal 4 digit PIN on the Set PIN pop up screen Re enter your PIN on the Confirm PIN pop up screen Your PIN is now set and...

Page 125: ...lth care provider to understand your Bigfoot Unity Report The Report provides standardized information that can be used to identify trends to inform treatment decisions The Report is not intended to r...

Page 126: ...About on the My Settings screen to display this information Tap My Settings to return to the My Settings screen Help and Support Help and Support provides an easy way to access helpful information wh...

Page 127: ...me For example if you sleep for 9 hours without scanning your Sensor 1 hour of data will not be collected and a gap will Appear on your App glucose graph Keep your phone within communication range 20...

Page 128: ...ED emission standards for safe use onboard an aircraft RTCA DO 160 Section 21 Category M for radiated emission Some airport full body scanners include x ray or millimeter radio wave to which you canno...

Page 129: ...ing the Cap Cleaning the Inside of the Cap 1 Remove the Cap from the insulin pen 2 Wipe down the inside of the Cap that comes into contact with the insulin pen Use a Bigfoot alcohol prep pad or a clea...

Page 130: ...oving your pen needles 9 4 Insulin Pens Refer to the manufacturer s instructions that came with your insulin pens for steps on using storing and discarding your pens 9 5 Disposal If you receive new Ca...

Page 131: ...ulin instead of Correction units when you just scanned your Sensor This message indicates that you have dosed rapid acting insulin within the past 3 hours and it is still active in your body What to d...

Page 132: ...ce 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 What to do Charge your Cap as soon as possible Caps should be charged...

Page 133: ...hite Cap when I was deciding how much rapid acting insulin to dose The Meal Correction screen will not appear when 1 you want to make a treatment decision using a Sensor glucose value within the first...

Page 134: ...roblem What it may mean Your White Cap is unable to pair with your Meter What to do Your App will also display a Pairing Error message Follow the instructions in your App for pairing your Meter with y...

Page 135: ...or is still in its start up period within 60 minutes from first application What to do Wait the number of minutes indicated to scan again or check your blood glucose with your Meter using a drop of bl...

Page 136: ...o 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 i...

Page 137: ...nge 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 sendi...

Page 138: ...Sensor What to do 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 Problem What it m...

Page 139: ...ow glucose according to your health care provider s recommendations When necessary use your Meter to check and obtain a glucose value Problem What it may mean or Your scanned glucose result is very hi...

Page 140: ...ollowing 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 E...

Page 141: ...blood glucose result while you await a new Meter Problem What it may mean Your Meter is unable to provide an accurate result What to do Re test with a new test strip If the problem continues you may...

Page 142: ...mmendations Checking ketones may be advisable 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...

Page 143: ...onger than 10 minutes take another blood glucose reading Make sure the Meter and Cap are turned on and within range of each other If Meter results still do not appear on the White Cap use the App to r...

Page 144: ...ished 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 Custom...

Page 145: ...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 Se...

Page 146: ...osing record will be grayed out when reviewing MY HISTORY Insulin Dose Make sure you note this information when it s time to decide how much insulin to dose the next time you inject insulin from your...

Page 147: ...der s recommendations for managing high glucose Bigfoot Unity will not alert you when your glucose is high Problem What it may mean You are not receiving Low Glucose Sensor Unavailable or Missed Long...

Page 148: ...tifications including Sounds Lock Screen or Banners turned on 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...

Page 149: ...d Alerts and what to do Some Notifications are considered critical to your glucose management and will be followed by an Alert A 1 Home Screen Display Information Your Home screen provides updated inf...

Page 150: ...low end of the factory 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 Follow your health care provider s reco...

Page 151: ...r 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 Follow your health care provider s recommend...

Page 152: ...nding 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 wi...

Page 153: ...lucose according to your health care provider s recommendations Alert will repeat in 45 minutes unless Sensor glucose rises above 65 mg dL If you do not tap OK Alert will repeat every five minutes Ale...

Page 154: ...able to communicate with the 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 Alert What it may mean OK No glucose alerts...

Page 155: ...Sensor is able to communicate with the 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 Alert What it may mean The Sensor...

Page 156: ...tap OK Alert will repeat every five minutes until the Sensor is able to communicate with the App phone Alert What it may mean The Sensor needs more time to adjust to your body before it can begin send...

Page 157: ...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 Alert What it may mean The Sensor s up to...

Page 158: ...in the time period you set for keeping track of long acting insulin dosing What to do Check the Time Since Last Dose on your Black Cap to verify if a long acting dose is needed You may have received t...

Page 159: ...rge units of rapid acting Small Medium Large Option A Enter the typical rapid acting insulin dose for small medium and large amount of carbs in a meal Breakfast Lunch Dinner units of rapid acting Brea...

Page 160: ...ay be added in app Number ranges should continue with the next number and not overlap i e 100 200 201 300 units units units units units units Option A Option B Glucose Target Correction Factor These v...

Page 161: ...tem User Guide Appendix C Appendix C Technical Information C 1 Labeling Symbols Symbols What it means Consult instructions for use Temperature Manufacturer Batch code Type BF applied part Use by date...

Page 162: ...nings 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 cont...

Page 163: ...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 0 C to 45 0 C Sensor Applicator and Sensor Pac...

Page 164: ...ate blend developed specifically for wearable devices Makroblend has a wide history of use in wearable medical devices and meets the biocompatibility testing requirements of ISO 10993 5 Cytotoxicity a...

Page 165: ...uency Near Field Communication 13 56 MHz RFID 2 402 to 2 480 GHz BLE GFSK C 5 Bigfoot Unity Diabetes Management System Specifications Bigfoot Unity System Specifications Operating Temperature 50 F to...

Page 166: ...proprietary data format and encryption This prevents unauthorized devices from accessing the data if they are within range and intercept the transmission Under normal operation the industry standard B...

Page 167: ...ginning of the Sensor wear period day 1 2 or 3 91 subjects were analyzed during the early middle period day 7 or 8 55 subjects were analyzed during the late middle period day 9 or 12 and 76 subjects w...

Page 168: ...thin 20 20 mg dL in first 12 hours MARD Adults 18735 144 92 4 87 5 81 7 9 2 Pediatrics age 12 17 5086 86 91 5 83 3 80 1 9 8 The accuracy of different CGM glucose ranges versus YSI reference was assess...

Page 169: ...mg dL Number of CGM Reference Pairs Percent Within 15 mg dL Percent Within 20 mg dL Percent Within 40 mg dL Percent Within 15 Percent Within 20 Percent Within 40 Mean bias mg dL MARD 54 125 70 4 77 6...

Page 170: ...Sensor determines that glucose level is below 40 mg dL it will report as 40 mg dL on the White Cap When the Libre 2 Sensor determines that glucose level is above 400 mg dL it will report as 400 mg dL...

Page 171: ...dult 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 0 of the time and less than or equal to 250 mg...

Page 172: ...dL 70 1 of the time between 121 and 160 mg dL 17 8 of the time between 161 and 200 mg dL 0 8 of the time and between 201 and 250 mg dL 0 1 of the time Table 3a Concurrence Analysis by CGM Glucose Lev...

Page 173: ...1 200 201 250 251 300 301 350 351 400 400 40 50 0 50 0 2 40 60 0 6 47 7 42 9 8 1 0 6 480 61 80 13 1 61 2 23 8 1 8 776 81 120 0 3 12 0 68 7 17 5 1 4 0 1 798 121 160 10 6 70 0 17 3 2 1 577 161 200 0 2 1...

Page 174: ...00 301 350 351 400 400 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 121 160 0 5 22 3 69 6 7 7 2418 161 200 0 1 0 1 1 5 26 9 62 5 9 0...

Page 175: ...1 200 201 250 251 300 301 350 351 400 400 40 100 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 1 834 121 160 0 5 2 2 22 1 63 8 11 4 633 161 200 2 5 23 0 60 7...

Page 176: ...me 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...

Page 177: ...have Definition Percentage of time the alert issued and blood glucose was not below the alert level within 15 minutes before or after the alert Detection Rate Tells you When you were low did you get...

Page 178: ...2 Sensor readings within YSI values and the Mean Absolute Relative Difference MARD is presented for the following different wear periods in Tables 6a and 6b Beginning Adult 144 Subjects Day 1 2 or 3 P...

Page 179: ...nsors and wore two Sensors simultaneously Of the 146 Sensors in the Adult study 71 1 lasted until the final day of use 6 Sensors 4 1 had early sensor shut off where the Sensor algorithm detected that...

Page 180: ...7 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...

Page 181: ...hout 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 1...

Page 182: ...dix C 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...

Page 183: ...7 For pediatrics ages 12 17 PARD was 8 4 with CV of 6 0 Paired absolute difference PAD is a measurement of absolute difference in mg dL between paired CGM readings while PARD is the absolute relative...

Page 184: ...ain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor See your health care provider to understand how long ascorbic acid is active in your body Additional notes for...

Page 185: ...he different devices that make up the Bigfoot Unity System If you find that glucose values are not sent to your White Cap from the Meter or if Sensor or Cap data is not being sent to the App it may be...

Page 186: ...ules 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 op...

Page 187: ...t Unity is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domesti...

Page 188: ...uptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 seco...

Page 189: ...ould be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of the equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequen...

Page 190: ...gfoot Unity can be calculated using the table below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to f...

Page 191: ...pp Create an account 30 Download 30 Home screen 98 149 Settings 31 112 Setup 31 Applying Sensor 25 57 93 Arrows Glucose trend 76 B Backup diabetes management plan 18 20 88 106 141 Bigfoot Unity Report...

Page 192: ...74 Viewing insulin information 41 43 72 78 Check blood glucose 77 Cleaning 129 Computed tomography CT 18 Considerations if You Record a Dose You Did Not Take 87 Correction dose table 36 40 Correction...

Page 193: ...Arrow 76 Graph view 104 H Help and Support 11 126 History 104 Home screen Active Alert icon 98 Main menu options 104 Phone Settings icon 98 99 Hyperglycemia 142 Hypoglycemia 11 17 76 141 I Icons symbo...

Page 194: ...1 123 153 M Magnetic resonance imaging MRI 18 Making treatment decisions 82 Making updates to settings 113 Meal dose label 33 115 Meal Mealtime Insulin 33 34 79 Messages 103 149 Meter 20 54 110 Meter...

Page 195: ...can Sensor 59 75 83 96 Send settings from App to Caps 48 51 118 Send settings later 119 Sensor Application 25 57 93 First 12 hours of use 19 60 76 84 91 96 107 131 138 Removal 26 93 96 128 Start up pe...

Page 196: ...ser Guide T Trend Arrows Glucose 76 Troubleshooting 131 U Use Meter 20 60 76 84 91 131 138 V Very Low Glucose Alert 101 102 121 122 153 Viewing glucose information on White Cap 74 Viewing insulin info...

Page 197: ......

Page 198: ...their respective holders Emergen C is a trademark of Pfizer Inc Airborne is a trademark of Reckitt Benckiser The Bluetooth word mark and logos are registered trademarks owned by SIG Inc and any use o...

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