Livongo Blood Glucose Monitoring System Owner S Manual

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Livongo Blood Glucose Monitoring SystemOwner’s Manual

Table of ContentsChapter 1 – Your Livongo Blood Glucose Monitoring System6Indications for Use6The Livongo Blood Glucose Monitoring System7The Livongo Blood Glucose Meter8Livongo Test Strips9Livongo Control Solution9Livongo Lancing Device and LancetsLivongo Data Management System910Limitations11Your Doctor12Contact Us12Important Safety Instructions12Using This Owner’s Manual13Chapter 2 – Components14The Livongo Blood Glucose Monitoring System14Blood Glucose Test Strips15Lancing Device17Control Solution19Chapter 3 – Getting Started20Turning On and Setting Up Your Livongo Meter20Sleeping and Turning Off Your Livongo Meter22Your Livongo Meter23The Display Screen24Chapter 4 – Checking Your Blood Glucose26Mealtime Tags32Feeling Tags36Changing Your Selections39If Data Transmission Is Unsuccessful40Before CheckingSafety TipsHow To Check Your Blood Glucose2262626

What Do Your Results Mean?41-42Chapter 5 – Viewing Results - My Logs44Log Book45All Stats46Meal Summary49Chapter 6 – Share & Support50Contact Coach51Share My Report52Member Support55Chapter 7 – Messages56Messages56Answer On the Go59Chapter 8 - Settings60Help60About60Airplane re UpdateChapter 9 – Your Personal Web Portal70Logging In70Home71Coaching and Report75Settings79Help82Chapter 10 – Checking Your Livongo Meter84Using Control Solution85Checking your Livongo Meter with Control Solution853

Control Solution Troubleshooting87Chapter 11 – Maintenance88Cleaning and Disinfecting Your Livongo Meter88Battery92Storing Your Livongo Meter & Strips93Chapter 12 – Troubleshooting94Basic Troubleshooting94Error Messages94The Livongo Blood Glucose Monitoring System99Chapter 13 – Specications and Limitations99Specifications99Operating Ranges99Electrical & Power Ratings99Environmental100Chapter 14 – Warranty and Compliance101Limitations On Warranty101For Warranty Service101FCC Statement102Radio Frequency Radiation Exposure Information102California Proposition 65 Warning103Privacy Policy1034

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Chapter 1Your Livongo Blood GlucoseMonitoring SystemThank you for choosing the Livongo Meter as your gateway to managingyour diabetes. Your new Livongo Meter system will help you monitoryour glucose to help you lead a healthier life. This Owner’s Manual hasimportant information about the system and how it works. Please read itcarefully before using your Livongo Meter because it will help you make themost of it.Indications for UseThe Livongo Blood Glucose Monitoring System (Livongo BGMS) is an OverThe-Counter (OTC) device utilized by persons with diabetes in home settingsfor the quantitative measurement of glucose in fresh whole capillary blood fromthe fingertips. It is intended for use by people with diabetes mellitus at homeas an aid to monitor the effectiveness of their diabetes control program. TheLivongo BGMS is for in vitro diagnostic use only and should not be used for thediagnosis of /or screening for diabetes mellitus or neonatal use. The LivongoBGMS is intended to be used by a single person and should not be shared.The Livongo Blood Glucose Test Strips (Livongo strips) are used with the LivongoBlood Glucose Meter (Livongo Meter) in the quantitative measurement ofglucose in fresh capillary blood from the fingertip.The Livongo Control Solution is for use with the Livongo Meter and LivongoTest Strips as a quality control check to verify that the meter and test strips areworking together properly and that the test is performing correctly.6

The Livongo Meter is associated with a Livongo member account, whichautomatically captures all the blood glucose data and related information entered,and displays tables and charts summarizing the data. The Livongo Blood GlucoseMonitoring System does not recommend any medical treatment or medicationdosage level.The Livongo Blood Glucose Monitoring SystemThe Livongo Health , Inc. Livongo BGMS, is an OTC system designed for theself-monitoring of blood glucose by persons with diabetes in home settings toaid in diabetes management. The system consists of the following components:7510:22 AM SAT, FEB 7CHECK BGMY LOGSSHARE &SUPPORTMESSAGESSETTINGS1 2ContrSolutPL00175.B6312ContSolutPL00175.B541. Livongo Connected Meter2. Livongo Lancing Device3. Livongo Lancets4. Livongo Blood Glucose Test Strips5. Livongo Blood Glucose Control Solution6. AC Adapter (wall charger) and USB Charger7. Carrying Case7

The Livongo Blood Glucose MeterYour Livongo Meter is easy to use. It has a color touch screen that lets youeasily select features like checking your blood glucose, viewing your Log Book,sharing your results, and viewing Healthy Living tips.It gives accurate glucose test results in just 5 seconds using a small bloodsample.The Livongo Meter stores your glucose results in its memory so that you canview later. The meter can automatically send your blood glucose data wirelesslyand securely to your Livongo Member Account. You can also choose to sendyour results to your healthcare team to help you and your healthcare teammanage your diabetes.The meter will let you know when you are running out of test strips and need toreorder. But remember, the Livongo Meter is not intended to provide automatedtreatment guidance or decisions, and it’s not a substitute for your professionalhealthcare provider.8

Livongo Test StripsThe Livongo Test Strips measure glucose in whole blood. The Livongo Stripsare designed for use with the Livongo Meter only. Each strip is to only beused once, and then discarded.Livongo Test Strips are packaged as a 50 count of strips in sealed vials.Livongo Control SolutionThe Livongo Blood Glucose Control Solutions are for use with the LivongoMeter and Livongo Test Strips as a quality control check to verify that themeter and test strips are working together properly and that the test isperforming correctly.The solution may also be used to practice taking readings, or to check thatyou are following the correct testing procedure without using your ownblood. If the monitor reading is within the control solution’s acceptablerange, the meter is working correctly.Livongo Lancing Device and LancetsThe Livongo Lancing Device is intended for use with Livongo Lancets,which are disposable sterile lancets, to draw small amounts of capillaryblood from the fingertips to test with the Livongo meter and test strips. TheLivongo Lancing Device is intended for single patient use.9

Livongo Data Management SystemThe Livongo Data Management System is an optional accessory to assistyou in monitoring your blood glucose levels using the Livongo Blood GlucoseMonitoring System. The website is password-protected to ensure that yourdata is secure and not mixed with another user’s. The software is an accessorywhich allows you to automatically collect the data captured by the meter, reviewaverages, highs and lows, and meal time blood glucose values, and organize itin various reports and graphs.NOTES: The Livongo Meter must only be used outside the body (in vitro diagnosticuse). It should only be used with Livongo Blood Glucose Test Strips and LivongoControl Solutions. It should only be used for testing glucose (sugar) with fresh capillary wholeblood samples. It should NOT be used to diagnose DKA (Diabetic Ketoacidosis) or to testneonates. It should NOT be stored in the refrigerator or in the car.WARNINGS:1. Your Livongo Meter contains small parts. Keep it out of the reach of smallchildren and pets.2. If you don’t recognize the symptoms of hypoglycemic a blood glucose meteris critical to your care. Since any monitor may fail, break, or be misplaced,you should always have a backup monitor.3. Blood samples and blood products are potential sources of hepatitis andother infectious diseases. Handle all parts of your device with care. Do notshare your Livongo Meter. It is for single-patient use only. Any items thatare used to measure glucose like test strips, lancets, and alcohol swabs,must be disposed of safely to avoid the risk of infection. Please follow yourhealthcare provider’s instructions for proper disposal.10

4. Healthy Living tips are not intended to provide advice on treatmentdecisions nor provide or supplement clinical care from your healthcareprofessional.LimitationsThe test strips give accurate results when the following limitations are observed: The test strips should not be used to diagnose or screen for diabetes, DKA,or to test neonates. Each test strip is for a single check only. Do not reuse the strips. Use a new,sterile Livongo Test Strip each time you check. Your test strips are for personal use only. Do not share them with anyone,including relatives. Use only fresh capillary whole blood from the finger. Do not use serum orplasma. There is no effect on blood glucose for altitudes up to 8,516 feet (2,595meters) above sea level. This meter should be operated in temperatures ranging from 41 F to 113 F(5 C to 45 C). Extremes in humidity (higher than 90% and lower than 10%) may affectresults. The Livongo Test Strips are calibrated against plasma. Glucose test results may be falsely low if you are severely dehydrated, if youare in shock, or in hyperosmolar crisis. Critically ill patients should not be tested with the Livongo Meter.11

Your DoctorPlease use your Livongo Meter with care. If you experience symptomsthat are not consistent with your blood glucose test results, and you havefollowed all the instructions in this Owner’s Manual, consult your doctor orhealthcare professional immediately. It is always better to be safe.Contact UsLivongo Meter is made by Livongo Health, Inc.444 N. Michigan Avenue, Suite 2880Chicago, IL 60611Inside the USA, please call Customer Service toll-free at800.945.4355, 24 hours 7 days a week or visit our website at:www.my.livongo.comImportant Safety InstructionsPlease take a moment to read through this important safety information.Remember, this is a medical device and it needs to be treated with care.In particular, there is the risk of disease transmission when using bloodglucose monitoring systems and they should be used with caution andcare: The Livongo Blood Glucose Monitoring System and lancing device arefor single patient use. For safety reasons, do not share it with anyone,including your family members. Many parts of your device come into contact with your blood and arebiohazardous. Kit parts can potentially transmit infectious diseases, evenafter being cleaned and disinfected. Always wash your hands thoroughly with soap and water and dry wellafter handling the meter, test strips, or your lancing device. Always consult your diabetes healthcare professional and follow his orher guidance about your blood glucose monitoring routine. If this device is used in a manner not specified by the manufacturer, theprotection provided against hazards may be impaired.12

The Livongo Blood Glucose Monitoring System is delivered fullyassembled.Using This Owner’s ManualWe have included some additional information in this Owner’s Manual,including:NOTES – helpful information for day-to-day use.CAUTIONS – important tips to protect your glucose meter.WARNINGS – crucial information that will help you use your glucose metersafely and tell you about the risks of receiving inaccurate readings.“FDA Public Health Notification: Use of Fingerstick Devices on Morethan One Person Poses Risk for Transmitting Bloodborne Pathogens:Initial Communication” (2010) Notices/ucm224025.htm“CDC Clinical Reminder: Use of Fingerstick Devices on More than OnePerson Poses Risk for Transmitting Bloodborne Pathogens” (2010) icesBGM.html13

Chapter 2ComponentsThe Livongo Blood Glucose Monitoring SystemYou have everything you will need in your Livongo Blood GlucoseMonitoring Kit to check and send your blood glucose to your personalaccount. It includes: Livongo Blood Glucose Meter Getting Started Guide AC charger and USB cord Instructions for UseAdditionally, in the Welcome Kit: Test Strips Lancing device and lancets Control solution (2 bottles-Level 1 and Level 2) Carrying caseYour new Livongo Meter is in a package that contains a “User Guide” whichshows you the features of the Livongo Meter. Please review the User Guidebefore starting. The Livongo Meter will be partly charged and ready to gowhen you take it out of the box. Plug it in overnight to fully charge it. Undernormal blood glucose monitoring conditions, the charge should last forseveral weeks.14

Blood Glucose Test StripsEdge to apply blood sampleTest area to hold the bloodInsert in the meterThe Livongo Blood Glucose Test Strips are designed for use with yourLivongo Blood Glucose Monitoring System only. Use each test strip onlyonce, and then discard it. It is important to note that you shouldnot reapply blood to the test strip.The strips come in a variety of colors but all give identical results. They maycome in vials or in individually sealed packages with a single test strip.Livongo Glucose Test Strips require only a small amount of blood (0.8µL)and automatically draw blood into the test area of the strip. They can behandled with clean, dry hands without affecting the readings. They areconvenient whether you test at home or on the go.Important Blood Glucose Test Strip InformationPlease remember: Use only Livongo Blood Glucose Test Strips when testing for glucose.The Livongo Blood Glucose Tests strip will only work with the LivongoBlood Glucose meter. Remove the test strip from the vial/foil only when ready to check yourglucose. Store the test strip package between 41-86 F and between 10% and90% relative humidity. Keep out of direct sunlight.15

Store the test strips in their original packaging only. After removing a glucose test strip from the vial, immediately replace thecap and close the vial tightly. Do not use test strips beyond the expiration date printed on the packageas this may cause inaccurate results. Test strips should only be stored for 6 months after opening. Discard anyremaining test strips after this date.WARNING: The test strip vials and packaging contain small parts. Keep awayfrom children and pets.16

Lancing DeviceCocking BarrelLancet HolderSterile LancetSafety TabRelease ButtonPuncture DepthSettingsLancingDeviceCoverThe picture above shows your lancing device. This is the part of theLivongo Blood Glucose Monitoring System that takes the blood sample.To use it, you should:1. Unscrew the lancing device cover from the body of the lancing device.Insert a sterile lancet into the lancet holder and push it until the lancetcomes to a complete stop in the lancing device.2. Hold the lancet firmly in the lancet holder and twist the safety tab of thelancet until it loosens. Then pull the safety tab off the lancet. Save the safetytab for disposal.3. Carefully screw the cover back onto the lancing device. Avoid contact withthe exposed needle. Make sure the cover is fully sealed on the lancingdevice.DO NOT TOUCH THE LANCET TIP.4. Adjust the puncture depth by rotating the lancing device cover. There are17

a total of 6 puncture depth settings. To reduce discomfort, use the lowestsetting that still produces an adequate drop of blood: short-length bars forsoft skin; medium-length bars for normal skin, and long-length bars forthick or calloused skin.5. Pull the cocking barrel back to set the lancing device. You may hear a click.The device is now loaded and ready for obtaining a drop of blood.6. Prior to checking, wipe your hand with an alcohol swab or wash yourhands with soap. Use warm water to increase blood flow in your fingers ifnecessary. Then dry your hands thoroughly. Massage your hand from thewrist up to the fingertip a few times to stimulate blood flow.7. Hold the lancing device against the side of the finger to be lanced with thecover resting on the finger. Push the release button to prick your fingertip.You should hear a click as the lancing device activates. Gently massageyour finger from the base to the tip to obtain the required blood volume.Avoid smearing the drop of blood.8. After finishing your blood check, unscrew the end cap, carefully remove theused lancet, and dispose of it safely in an appropriate container.18

Control SolutionThe Livongo Blood Glucose Monitoring System Glucose Control Solution comesas vials of Level 1 and Level 2 solutions. They contain a known concentration ofglucose. They are used to confirm that your Livongo Blood Glucose Monitoringsystem and test strips are working together properly. They also confirm thatyou are performing the test correctly. It is important to run a quality control testregularly to make sure you are getting correct results.You can also use this solution to practice taking readings or to check that youare following the correct testing procedure without using your own blood. If themeter reading is within the control solution’s acceptable range, the meter isworking correctly.1 2ContrSolutPL00175.BContSolutPL00176.BPL00175.B19

Chapter 3Getting StartedTurning On and Setting up your Livongo Meter10:22 AM SAT, FEB 7CHECK BGMY LOGSSHARE &SUPPORTMESSAGESYou need to do very little to set upand use your meter. It will be partiallycharged but check to make sure thatthe battery is at least 50% full beforeusing it for the first time.To check the battery status, look atthe battery gauge icon in the top rightcorner of the screen. You want to see atleast two bars in the battery icon beforeyou check your blood glucose.SETTINGSBy pressing the side On/Off button, the Livongo logo screen will appear. Itwill beep for a few seconds as it finds the network. When the meter is firstturned on, it will prompt the user to select if they use insulin or not andwhat language they choose (English or Spanish). This message will not berepeated every time the meter is turned on, but the user can always changethese selections in the Settings menu.20

10:22 AM SAT, FEB 7The time and date are set automatically, nomatter where you are, and are shown at thetop of the Home screen. If you are traveling,the Livongo Meter will set your meter’s timeto the time zone that you are in. This is tomake sure that your readings are sent withright time stamp.Having the correct time and date of eachblood test result is important because ithelps you and your healthcare professionalunderstand your blood glucose patterns andcan be used to introduce changes in yourmanagement plan.The Livongo Meter will also automatically detect the wireless network thatyou are in and ‘roam’ if necessary. There is no charge to you for roaming orwireless connections.21

Sleeping and Turning off your Livongo MeterTo save battery, the screen on your Livongo Meter will go blank after1 minute of non-use and the device will go to sleep mode after 2 minutesof non-use. You can also “sleep” your Livongo Meter by pressing the On/Off button for 3 seconds. To “Power Down” and turn off your Livongo Metercompletely, just hold in the On/Off button until the device powers off. Youcan turn on the Livongo Meter by pressing the On/Off button.10:22 AM SAT, FEB 710:22 AM SAT, FEB 7 Powering downHold in for 3 secondsCAUTION: Always handle your Livongo Meter with care. Dropping the unitor exposing it to water, for example, may damage the sensitive monitoringequipment inside. If you are packing away your unit for an extended periodof time, protect it from moisture, prolonged direct sunlight, and extremetemperatures. Look after it, and it will keep looking after you.22

Your Livongo Meter3651241. On/Off button.2. Color touch display screen.3. Test strip port.4. USB charging port.5. Battery charge indicator.6. Wireless signal indicator.23

The Display Screen110:22 AM SAT, FEB 74CHECK BGMY LOGS8SHARE &SUPPORTMESSAGESSETTINGS325671. Signal strength2. Current date and time3. Battery level and charging state4. Check your blood glucose level5.

The Livongo Blood Glucose Meter Your Livongo Meter is easy to use. It has a color touch screen that lets you easily select features like checking your blood glucose, viewing your Log Book, sharing your results, and viewing Healthy Living tips. It gives accurate glucose test results in just 5 seconds using a small blood sample.

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