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
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| Document ID | 3027736 |
| Application ID | UJrovGE++Gtyw9hsMRYw2Q== |
| Document Description | user guide |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 163.01kB (2037679 bits) |
| Date Submitted | 2016-06-14 00:00:00 |
| Date Available | 2016-12-11 00:00:00 |
| Creation Date | 2016-06-14 16:08:49 |
| Producing Software | Adobe PDF library 15.00 |
| Document Lastmod | 2016-06-14 16:08:49 |
| Document Title | PL00415.A Livongo UserGuide English_draft |
| Document Creator | Adobe Illustrator CC 2015 (Macintosh) |
Livongo for Diabetes User Guide Contents Welcome Welcome 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. Page 1 of 26 The Livongo for Diabetes Program Getting started First blood glucose check Access your data at any time Coaching for any question Support when you need it most Keep your loved ones in the loop 10 Share your Summary Report 11 Unlimited supplies 13 Charging the Livongo meter 14 Power on / Power off / Sleep mode 14 Customize your settings in the Livongo meter 15 Troubleshooting error messages 16 Appendix 20 Page 2 of 26 Getting started The 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: The Livongo for Diabetes Program • Turn on your meter by pressing the power button for 3 seconds The Livongo for Diabetes program is a completely new approach to diabetes management designed to empower you to make better decisions. • Select language preference (English or Spanish) 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. Page 3 of 26 • Select whether you use insulin Now 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 26 First blood glucose check 10:22 AM SAT, FEB 7 CHECK BG SHARE & SUPPORT 10:22 AM SAT, FEB 7 Ready to Check Glucose 10:22 AM SAT, FEB 7 121 MY LOGS MESSAGES Cancel Power up your meter, place it on a flat surface and insert a test strip Wait for meter to display “Ready to Check Glucose” Cancel Apply a drop of blood into strip chamber 10:22 AM SAT, FEB 7 10:22 AM SAT, FEB 7 121 mg/dL Last BG: 141 ( 12/25 6:30 PM ) SETTINGS Page 5 of 26 10:22 AM SAT, FEB 7 Ready to Check Glucose Before Breakfast After Breakfast Before Lunch After Lunch Before Dinner After Dinner No Meal Other / Snack Select a meal tag. If you take insulin, you’ll have the option to log insulin and carbs 121 mg/dL Last BG: 141 ( 12/25 6:30 PM ) I feel fine I don’t feel well Light headed Stressed out After exercise Ate more Took more meds Missed meds Other Select a tag that describes how you’re feeling mg/dL Last BG: 141 ( 12/25 6:30 PM ) After Breakfast Edit I feel fine Edit Submit Click “Submit” to securely upload your blood glucose reading and tags (meals and feelings) to your private account Page 6 of 26 Welcome to Livongo Coaching for any question 116 121 105 All 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: Access your data at any time • From the Livongo meter, click “Share & Support” and then “Contact Coach”. You 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. • 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. 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. Page 7 of 26 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 Educator Page 8 of 26 Edit Low Notification Level Support when you need it most Keep your loved ones in the loop If 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. You can choose to notify your loved ones automatically by email or text message when you get low or high blood glucose readings. 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”. Page 9 of 26 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”. Page 10 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. Share from Meter 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”. Health Summary 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. 120 130 Page 11 of 26 Page 12 of 26 Charging the Livongo meter Your 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 / Storage Unlimited supplies Your 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 13 of 26 To 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. Page 14 of 26 Customize your settings in the Livongo meter Troubleshooting error messages You can personalize your Livongo meter to best suit your needs. In the event of an error while checking your blood glucose, an error message will appear on your meter screen. 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 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 Strip The strip that you are using is either contaminated or has been used. Please use a new strip and try again. Insufficient Blood Sample Sometimes 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 High The outside temperature is above 113°F, which is too high to give an accurate reading. Temperature too Low The outside temperature is below 41°F, which is too low to give an accurate reading. • 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 15 of 26 Page 16 of 26 Troubleshooting error messages (cont.) Troubleshooting error messages (cont.) In the event of an error while checking your blood glucose, an error message will appear on your meter screen. 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/dL The 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/dL Livongo 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. Page 17 of 26 Internal Calibration Error Please 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 Error If 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. Page 18 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. Appendix 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”. Page 19 of 26 Page 20 of 26 Specifications and Limitations Specifications Operating Ranges Electrical & Power Ratings Environmental • Test measured: Blood glucose • Temperature: 41°F to 113°F (5°C to 45°C) • Electrical specifications: 3.7V Li-Polymer Battery 1100mAh • Humidity: 10% to 90% relative humidity • Maximum current (Battery): 650mA peak • The storage temperature range for the meter: -13°F to 115°F (-25°C to 46°C). • Altitude: up to 8,516 ft (2,595 m) • Maximum power (Battery): 3.0W peak • Weight: 2.65 oz (75 g) • Maximum current (USB input, charging): 1A continuous • 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 • Size 3.6x2.3x0.9 in (96 x57 x 17.7 mm) • Test strip volume: 0.8 µL • Meter data storage: 1000 results Page 21 of 26 • USB charging input: 5V 1A • 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. Page 22 of 26 FCC Statement This 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 23 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 Warning THIS PRODUCT CONTAINS CHEMICALS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM. Page 24 of 26 Warranty For Warranty Service Your 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. Please contact Member Support at 800.945.4355. Limitations On Warranty This warranty is subject to the following exceptions and limitations: 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. • 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 25 of 26 Page 26 of 26 PL00415 Rev.A Welcome Kit Components 10:22 AM SAT, FEB 7 CHECK BG MY LOGS SHARE & SUPPORT MESSAGES SETTINGS 2mL REF OFG00155 REF OFG00155 1-800-945-4355 24/7 member support 1-800-945-4355 24/7 member support 2mL 1 2 Control Solution PL00175.B For in vitro diagnostic use For in vitro diagnostic use only. Store at 41-86°F andonly. Store at 41-86°F and 10-90% relative humidity.10-90% relative humidity. Control Solution Lot: Lot: Exp: PL00175.B Exp: Your welcome kit comes with below components in the Livongo Blood Glucose Monitoring System: • Livongo Connected Meter (1) • Livongo Lancing Device (1) • AC Adapter (wall charger) and USB Charger (1) • Livongo Lancets (100) • Instructions for Use (1) • Livongo Blood Glucose Test Strips (150) • Carrying Case (1) • Livongo Blood Glucose Control Solution (2 • Owner’s Manual (at my.livongo.com) • Livongo User Guide (1)
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