LV00408 Blood Glucose Monitor user guide Users Manual

 

Livongo for Diabetes User Guide 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. Were available 24 hours a day, seven days a week. Contents 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 Share your Summary Report Unlimited supplies Charging the Livongo meter Power on / Power off / Sleep mode Customize your settings in the Livongo meter Troubleshooting error messages Appendix 3 4 5 7 8 9 10 11 13 14 14 15 16 20 Page 1 of 26 Page 2 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 benets. Getting started The Livongo meter comes ready to use right out of the box and is already charged. First, congure your Livongo meter to best t your needs. Steps to congure your meter:

Turn on your meter by pressing the power button for 3 seconds Select language preference (English or Spanish) Select whether you use insulin Now your Livongo meter is ready for your rst blood glucose check. Note: Your meters date and time will be automatically updated after you do your rst check. Page 3 of 26 Page 4 of 26 First blood glucose check CHECK BG MY LOGS SHARE &

SUPPORT MESSAGES SETTINGS Ready to Check Glucose Ready to Check Glucose Cancel Cancel 1 2 3 mg/dL 121 Last BG: 141 ( 12/25 6:30 PM ) mg/dL 121 Last BG: 141 ( 12/25 6:30 PM ) mg/dL 121 Last BG: 141 ( 12/25 6:30 PM ) Before Breakfast After Breakfast Before Lunch Before Dinner No Meal After Lunch After Dinner Other /

Snack 4 I feel ne I dont feel well Light headed Stressed out After exercise Ate more Took more meds Missed meds Other 5 After Breakfast I feel ne Edit Edit Submit 6 Power up your meter, place it on a at surface and insert a test strip Wait for meter to display Ready to Check Glucose Apply a drop of blood into strip chamber Select a meal tag. Select a tag that describes If you take insulin, youll have the option to log insulin and carbs how youre feeling Click Submit to securely upload your blood glucose reading and tags (meals and feelings) to your private account Page 5 of 26 Page 6 of 26 10:22 AM SAT, FEB 710:22 AM SAT, FEB 710:22 AM SAT, FEB 710:22 AM SAT, FEB 710:22 AM SAT, FEB 710:22 AM SAT, FEB 7 Welcome to Livongo 116 121 105 Access your data at any time 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. 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 youve used the Livongo meter for some time, the trends and graphs can help you better manage your diabetes effectively. Page 7 of 26 Coaching for any question All Livongo coaches are Certied 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, youll be able to continue the conversation by phone, email or text message. Kendall Brooks, Registered Dietitian &

Certied Diabetes Educator Page 8 of 26 Edit Low Notication Level Support when you need it most 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. 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. 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 benet. To customize this benet, go to my.livongo.com, click Coaching & Report at the top of the screen and select Coaching Support. To enable and customize this feature, log in to my.livongo.com, click Coaching & Report at the top of the screen and select Notications to Friends and Family. Page 9 of 26 Page 10 of 26 Share your Summary Report Livongos Summary Report has been specically 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 doctors 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. Youll be able to download your report or share it by email. Share from Meter Health Summary Report 1 2 120 130 Page 11 of 26 Page 12 of 26 Charging the Livongo meter Your Livongo meter is powered by a rechargeable battery. Youll receive a notication 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 wont be able to use the meter while its charging. Please wait for 30 minutes after charging to check your blood glucose. Power on / Power off / Sleep mode / Storage 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 its 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 supplies Your membership includes unlimited strips and lancets. There are no hidden costs or co-pays. Youll automatically receive a notication on your meter when we think you might need more strips. After you conrm, well ship more supplies, right to your door. If you dont see a notication 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 Page 14 of 26 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, youll be able to congure:

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. Troubleshooting error messages In the event of an error while checking your blood glucose, an error message will appear on your meter screen. 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. Insufcient 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 113F, which is too high to give an accurate reading. Temperature too Low The outside temperature is below 41F, which is too low to give an accurate reading. Page 15 of 26 Page 16 of 26 Troubleshooting error messages (cont.) In the event of an error while checking your blood glucose, an error message will appear on your meter screen. 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, youll 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 Glucose Low:

< 20 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. 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. 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 meters 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 17 of 26 Page 18 of 26 Were 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 nd 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. Appendix Page 19 of 26 Page 20 of 26 Specications and Limitations Specications Operating Ranges Electrical & Power Ratings Environmental Test measured: Blood glucose Temperature: 41F to 113F

(5C to 45C) Electrical specications: 3.7V Li-Polymer Battery 1100mAh 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 L Humidity: 10% to 90% relative Maximum current (Battery):

humidity 650mA peak Altitude: up to 8,516 ft Maximum power (Battery):

(2,595 m) 3.0W peak Weight: 2.65 oz (75 g) Size 3.6x2.3x0.9 in (96 x57 x 17.7 mm) Meter data storage: 1000 results Maximum current (USB input, charging): 1A continuous USB charging input: 5V 1A The storage temperature range for the meter: -13F to 115F

(-25C to 46C). The storage temperature range for the test strips: 41F to 86F

(5C to 30C). The meter operational temperature range: 41F to 113F (5C to 45C). The relative humidity range:

10% to 90% non-condensing. Page 21 of 26 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. Modications 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.

-- 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 Livongos server. The device communicates with Livongos 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 Livongos 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 23 of 26 Page 24 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. Warranty 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 rst 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 25 of 26 Page 26 of 26 Welcome Kit Components CHECK BG MY LOGS SHARE &

SUPPORT MESSAGES SETTINGS 2mL PL00415 Rev.A REF OFG00155 1-800-945-4355 24/7 member support REF OFG00155 2mL 1-800-945-4355 24/7 member support 1 Control Solution For in vitro diagnostic use only. Store at 41-86F and 10-90% relative humidity. 2 Control Solution Lot:

Exp:

PL00175.B PL00175.B Lot:

Exp:

For in vitro diagnostic use only. Store at 41-86F and 10-90% relative humidity. Your 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) Owners Manual (at my.livongo.com) 510:22 AM SAT, FEB 7