Livongo Health LV00408 Blood Glucose Monitor User Manual PL00415 A Livongo UserGuide English draft

Livongo Health, Inc. Blood Glucose Monitor PL00415 A Livongo UserGuide English draft

user guide

Livongo for Diabetes User Guide
WelcomeWelcome to the Livongo for Diabetes program. This guide will help you get started in less than 5 minutes. If you have any questions, please call Member Support at 800.945.4355 or email us at membersupport@livongo.com. We’re available 24 hours a day, seven days a week.ContentsThe Livongo for Diabetes Program Getting startedFirst blood glucose checkAccess your data at any timeCoaching for any questionSupport when you need it mostKeep your loved ones in the loopShare your Summary ReportUnlimited suppliesCharging the Livongo meterPower on / Power off / Sleep modeCustomize your settings in the Livongo meterTroubleshooting error messagesAppendix3457891011131414151620Page 2 of 26Page 1 of 26
The Livongo for Diabetes Program The Livongo for Diabetes program is a completely new approach to diabetes management designed to empower you to make better decisions.The Livongo for Diabetes program includes: the Livongo meter, unlimited strips and lancets, access to coaches at any time, personalized insights, and much more. Get started to discover all the benefits.Getting startedThe Livongo meter comes ready to use right out of the box and is already charged. First, configure your Livongo meter to best fit your needs.Steps to configure your meter:• Turn on your meter by pressing the power button for 3 seconds• Select language preference (English or Spanish)• Select whether you use insulinNow your Livongo meter is ready for your first blood glucose check.Note: Your meter’s date and time will be automatically updated after          you do your first check.Page 4 of 26Page 3 of 26
First blood glucose check10:22 AM   SAT, FEB 7SETTINGSCHECK BG MY LOGSSHARE & SUPPORTMESSAGES10:22 AM   SAT, FEB 7CancelReady to Check Glucose10:22 AM   SAT, FEB 7CancelReady to Check Glucose1 2 3Power up your meter, place it on a flat surface and insert a test stripWait for meter to display “Ready to Check Glucose”Apply a drop of blood into strip chamber10:22 AM   SAT, FEB 7BeforeBreakfastAfterBreakfastBeforeLunchAfterLunchBeforeDinnerAfterDinner121Last BG: 141 ( 12/25 6:30 PM ) NoMealOther / Snackmg/dL10:22 AM   SAT, FEB 7121Last BG: 141 ( 12/25 6:30 PM ) mg/dLI feel fine I don’t feel wellLight headedStressed outAfter exerciseAtemoreTook more medsMissed meds Other10:22 AM   SAT, FEB 7121Last BG: 141 ( 12/25 6:30 PM ) mg/dLAfter BreakfastI feel fineSubmitEditEdit4 5 6Select a meal tag.  If you take insulin, you’ll have the option to log insulin and carbsSelect a tag that describes how you’re feelingClick “Submit” to securely upload your blood glucose reading and tags (meals and feelings) to your private accountPage 6 of 26Page 5 of 26
Access your data at any timeYou can access your data on the Livongo meter by tapping the “My Logs” icon on the Home Screen. You can view your “Log Book”, “Meal Summary”, and “All Stats”, which is a summary of your statistics.You can also access your blood glucose readings in your private account at any time.To access your data online, you can log in to my.livongo.com. Once you’ve used the Livongo meter for some time, the trends and graphs can help you better manage your diabetes effectively.Coaching for any questionAll Livongo coaches are Certified Diabetes Educators who can answer any diabetes questions, from nutrition to lifestyle changes. Your coach will get to know you and provide you with the one-on-one support you need.  There are two ways to reach out to a Coach:• From the Livongo meter, click “Share & Support” and then “Contact Coach”.• From my.livongo.com, click “Coaching & Report” and then “Coaching Support” from the menu at the top. You can then request a coaching session on that page.Once you speak with a coach, you’ll be able to continue the conversation by phone, email or text message. Kendall Brooks,Registered Dietitian & Certified Diabetes EducatorWelcome to Livongo116105121Page 8 of 26Page 7 of 26
Keep your loved ones in the loop You can choose to notify your loved ones automatically by email or text message when you get low or high blood glucose readings. To enable and customize this feature, log in to my.livongo.com, click “Coaching & Report” at the top of the screen and select “Notifications to Friends and Family”.Support when you need it mostIf your blood glucose reading is high or low, our coaches will contact you within 5 minutes to help you manage your blood glucose back into target range. By default, the blood glucose thresholds are set to 60 mg/dL and 400 mg/dL. You can customize these thresholds or, if you prefer, opt out of this benefit. To customize this benefit, go to my.livongo.com, click “Coaching & Report” at the top of the screen and select “Coaching Support”.Edit Low Notification LevelPage 10 of 26Page 9 of 26
Share your Summary Report  Livongo’s Summary Report has been specifically designed for you to easily share your data with your Doctor every few months.It provides a summary of your readings, along with charts and trends, so that you can spend more time on meaningful conversations with your doctor.There are two ways you can share the Summary Report:1. From your meter: From your Livongo meter home page, go to “Share & Support” and then click on “Share My Report”. To enable this feature, please add your doctor’s email address to your account beforehand. To do this, go to my.livongo.com, click “Coaching & Report” at the top of the screen and select “Share From Meter”.2. On the web: Go to my.livongo.com, click “Coaching & Report” at the top of the screen to open the drop down menu and select “Summary Report”. You’ll be able to download your report or share it by email.Share from Meter1Health Summary Report1201302Page 12 of 26Page 11 of 26
Charging the Livongo meterYour Livongo meter is powered by a rechargeable battery. You’ll receive a notification on the meter when your battery level is low. To charge it, plug the charger cord into the port on the left side of the meter. The meter will show the progress on the screen. Please note that you won’t be able to use the meter while it’s charging. Please wait for 30 minutes after charging to check your blood glucose.Power on / Power off / Sleep mode / StorageTo save battery, your Livongo meter will go to Sleep Mode after being inactive for 1 minute.To wake up the meter, you can simply press the power button or insert a test strip.To power off the Livongo meter, hold the power button for 3 seconds and the screen will indicate that it’s powering down. To turn the meter back on, hold the power button again for 3 seconds. The Livongo meter is best stored in the Livongo case included in the Welcome Kit. The case is designed to protect the device and help you carry everything you need to check your blood glucose. You can even check without removing the meter from the case.  Unlimited suppliesYour membership includes unlimited strips and lancets.  There are no hidden costs or co-pays. You’ll automatically receive a notification on your meter when we think you might need more strips.  After you confirm, we’ll ship more supplies, right to your door.If you don’t see a notification on your meter, you can always order more supplies at any time by clicking Reorder Now at my.livongo.com, or by calling Member Support at 800.945.4355.Page 14 of 26Page 13 of 26
Blood Applied Too Quickly Blood was applied too quickly after the strip was inserted and before the meter was ready. After inserting the strip, please wait until you see the message "Ready to Check Glucose" to apply blood.Contaminated or Used StripThe strip that you are using is either contaminated or has been used. Please use a new strip and try again.Insufficient Blood SampleSometimes the blood sample might be too small to be measured with accuracy. Please remove the strip and try again using a new strip. Glucose Strip Coding Error Please insert a new test strip from the same vial and try again. If the error persists, contact Member Support.Temperature too HighThe outside temperature is above 113°F, which is too high to give an accurate reading.Temperature too LowThe outside temperature is below 41°F, which is too low to give an accurate reading.Troubleshooting error messagesIn the event of an error while checking your blood glucose, an error message will appear on your meter screen. Customize your settings in the Livongo meter You can personalize your Livongo meter to best suit your needs.By tapping “Settings” on the Livongo meter home screen, you’ll be able to configure:• Insulin: you can select whether you take insulin.  Selecting “On” will allow you to log your insulin intake after your blood glucose checks• Language: you can choose from English and Spanish• Sounds: you can turn sounds on and off• Airplane Mode: you can turn off communications on the meter by turning your “Airplane Mode” on.• Reminders: you can set up to 3 alarm clock reminders to prompt you to take important actions, such as taking medications or checking your glucose.Page 16 of 26Page 15 of 26
Internal Calibration ErrorPlease turn off the meter for 30 seconds and turn it back on. If the error persists, contact Member Support.Internal Meter Error Please turn off the meter for 30 seconds and turn it back on. If the error persists, contact Member Support.Meter CRC Error  Repeat the BG check with the same test strip. If the error persists, contact Member Support.Communication ErrorIf you are not in cellular range, your blood glucose results will not be transmitted. The results will be stored in the meter’s memory and transmitted the next time you check your blood glucose or retrieve messages in your message inbox. If you have any questions about your Livongo meter, please contact Member Support at 800.945.4355 or email us at membersupport@livongo.com.  We are available 24 hours a day, seven days a week.Troubleshooting error messages (cont.)In the event of an error while checking your blood glucose, an error message will appear on your meter screen. Test Strip Removed If the strip is removed before a reading can be obtained, you’ll receive this error message. Please fully remove the strip and try again with a new strip.Hematocrit Error Your hematocrit level is below 20% or above 70% The Livongo meter operates in the hematocrit range of 20% to 70%. Very high (above 70%) and very low (below 20%) hematocrit levels can cause false results. Talk to your doctor to learn more about your hematocrit level.Glucose High: > 600 mg/dLThe Livongo meter can measure blood glucose accurately from 20 mg/dL to 600 mg/dL. If your blood glucose is higher than 600 mg/dL, the screen will display this message. Please call your Doctor if you receive this message.Glucose Low:< 20 mg/dLLivongo meter can measure blood glucose accurately from 20mg/dL to 600 mg/dL. If the blood glucose is lower than 20 mg/dL the screen will display this message. Please call your Doctor if you receive this message.Troubleshooting error messages (cont.)In the event of an error while checking your blood glucose, an error message will appear on your meter screen. Page 18 of 26Page 17 of 26
We’re here to help Do you have any questions? Contact us at any time at 800.945.4355, or via email at membersupport@livongo.com. We want to help you get the most out of the Livongo for Diabetes program.You can always find our phone number here in this guide, on the back of your meter, or by visiting my.livongo.com and clicking “Share & Support” then “Member Support”. AppendixPage 20 of 26Page 19 of 26
Specifications •  Test measured: Blood glucose•  Glucose methodology: Glucose oxidase biosensor•  Glucose test results: mg/dL (Plasma values)•  Measuring range: 20-600 mg/dL•  Acceptable hematocrit range: 20% to 70%•  Length of test: 5 seconds•  Test strip volume: 0.8 µLOperating Ranges •  Temperature: 41°F to 113°F (5°C to 45°C)•  Humidity: 10% to 90% relative humidity•  Altitude: up to 8,516 ft (2,595 m)•  Weight: 2.65 oz (75 g)•  Size 3.6x2.3x0.9 in (96 x57 x 17.7 mm)•  Meter data storage: 1000 results Electrical & Power Ratings•  Electrical specifications: 3.7V Li-Polymer Battery 1100mAh•  Maximum current (Battery): 650mA peak•  Maximum power (Battery): 3.0W peak•  Maximum current (USB input, charging): 1A continuous•  USB charging input: 5V 1AEnvironmental •  The storage temperature range for the meter: -13°F to 115°F (-25°C to 46°C).•  The storage temperature range for the test strips: 41°F to 86°F (5°C to 30°C). •  The meter operational temperature range: 41°F to 113°F (5°C to 45°C). •  The relative humidity range: 10% to 90% non-condensing.Specifications and LimitationsPage 22 of 26Page 21 of 26
-- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.-- Consult Livongo Health or an experienced radio/TV technician for help.Radiofrequency radiation exposure Information:The device uses cellular radio frequency technology to accomplish required communications with Livongo’s server. The device communicates with Livongo’s server only in three circumstances: when used to check blood glucose (which typically happens up to 8 times per day); before the device goes to sleep (which follows every blood glucose check); when used to share a summary report (which typically happens every 1-3 months). The average human exposure to such radio frequency radiation remains far below the regulatory limits set by the US Federal Communications Commission (FCC) provided that the device is used at positions as instructed in this manual during communication with Livongo’s server.California Proposition 65 WarningTHIS PRODUCT CONTAINS CHEMICALS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.FCC StatementThis device, model BG300, complies with Part 15 of the FCC Rules. Operation is subject to 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. Modifications not expressly approved by Livongo Health, Inc. could void the user's authority to operate the equipment.Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:-- Reorient or relocate the receiving antenna.-- Increase the separation between the equipment and receiver.Page 24 of 26Page 23 of 26
For Warranty Service Please contact Member Support at 800.945.4355.Privacy Policy As the manufacturer of Livongo meter, we are committed to securing your personal information responsibly and in compliance with the law. We pledge that we will not share or sell your personal information with marketers or third parties. The information you voluntarily share with us will only be used to help us provide you a better service in the future.WarrantyYour Livongo connected meter is guaranteed to be free of material and workmanship defects for one (1) year from the date of receipt (except as noted below). If at any time during the first year after purchase, your meter does not work for any reason (other than as described below), it will be replaced with a new meter free of charge. Limitations On Warranty This warranty is subject to the following exceptions and limitations: •  This warranty is applicable only to the original purchaser. •  This warranty does not apply to units that malfunction or are damaged due to obvious abuse, misuse, alteration, neglect, unauthorized maintenance or failure to operate meter in accordance with instructions.•  We have no knowledge of the performance of the Livongo meter when used with test strips other than Livongo Strips. Therefore, we make no warranty as to the performance of the Livongo meter when used with any test strips other than Livongo Test Strips.•  There is no other express warranty for this product. The option of replacement, described above, is the warrantor only obligation under this warranty. Page 26 of 26Page 25 of 26
Welcome Kit ComponentsYour welcome kit comes with below components in the Livongo Blood Glucose Monitoring System:• Livongo Connected Meter (1)• Livongo Lancing Device (1)• Livongo Lancets (100)• Livongo Blood Glucose Test Strips (150)• Livongo Blood Glucose Control Solution (2• Livongo User Guide (1)• AC Adapter (wall charger) and USB Charger (1)• Instructions for Use (1)• Carrying Case (1)• Owner’s Manual (at my.livongo.com)510:22 AM   SAT, FEB 7SETTINGSCHECK BG MY LOGSSHARE & SUPPORTMESSAGES2Control Solution2mLPL00175.BREF  OFG001551-800-945-4355 24/7 member support For in vitro diagnostic use only. Store at 41-86°F and 10-90% relative humidity.Lot:Exp:1Control Solution2mLPL00175.BREF  OFG001551-800-945-4355 24/7 member support For in vitro diagnostic use only. Store at 41-86°F and 10-90% relative humidity.Lot:Exp:PL00415 Rev.A

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