Livongo Health 3614-04 In Touch Blood Glucose Monitoring System User Manual Owners manual
EosHealth, Inc. In Touch Blood Glucose Monitoring System Owners manual
Owners manual
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| Document ID | 2142625 |
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| Document Description | Owners manual |
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| Document Type | User Manual |
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| Filesize | 105.56kB (1319454 bits) |
| Date Submitted | 2013-12-15 00:00:00 |
| Date Available | 2014-06-13 00:00:00 |
| Creation Date | 2013-12-11 17:40:56 |
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| Document Lastmod | 2013-12-11 17:40:56 |
| Document Title | Microsoft Word - In Touch Owners Manual 12112013 v1.7 |
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| Document Author: | Angelides |
IN TOUCH™ BLOOD GLUCOSE MONITORING SYSTEM OWNER’S MANUAL V1.6 CONTENTS Chapter 1 – Your In Touch™ .................................................. 5 Your In Touch™ Register Your In Touch™ Contact Us Important – Staying Safe Using This User Guide Chapter 2 – Overview ........................................................ 10 Indications for Use Your Doctor 11 13 Chapter 3 – Components ..................................................... 14 In Touch™ Glucose Test Strips Important In Touch™ Glucose Test Strip Information Lancing Device Control Solution 14 14 15 16 18 Chapter 4 – Getting Started ................................................ 19 Turning On and Setting up your In Touch™ Your In Touch™ Monitor The Display Screen 19 22 24 Chapter 5 – Checking Your Blood Glucose .......................... 25 Before Testing Safety Tips How To Test Mealtime Tags Feeling Changing Your Selections If Data Transmission Is Unsuccessful 25 25 26 31 32 34 36 Chapter 6 ‐ What Do Your Results Mean?........................... 38 Blood Sugar High Or Low Readings References 38 38 39 Chapter 7 – Forearm or Palm Testing.................................. 40 How to Test Limitations & Considerations 40 41 Chapter 8 – Viewing Results and Trends ............................. 43 Logbook Mealtime Values Patterns & Stats Steps and Calories Snapshot Summary 44 44 46 48 50 Chapter 9 – Your Messages ................................................. 51 Messages Team MyCoach MyMD MyFamily MyMobile 51 52 53 53 55 56 Chapter 10 – Your Personal Web Portal .............................. 57 Logging In Dashboard More Detail 57 58 58 Chapter 11 – Checking your In Touch™ ............................... 60 The Control Solution Test Using Control Solution Control Solution Troubleshooting Important Tips 60 61 65 66 Chapter 12 – Maintenance .................................................. 68 Cleaning Battery Storing Your In Touch™ & Test Strips 68 69 71 Chapter 13 – Settings Options ............................................. 73 Help Airplane Mode Activity Monitor Settings Reminders Calibrate Control About 73 73 75 76 76 78 Chapter 14 ‐ Troubleshooting ............................................. 79 Issues With Tests Basic Troubleshooting Error Messages Communication Errors 79 79 80 81 Getting Support 82 Chapter 15 – Specifications and Limitations ....................... 83 Specifications Operating Ranges Glucose Test Imprecision Environmental Limitations 83 83 83 84 84 Chapter 16 – Warranty and Compliance ............................. 86 Limitations On Warranty For Warranty Service FCC Interference Statement FCC Caution FCC Radiation Exposure Statement Privacy Policy US Patent No. 7,935,307, 8,066,640, 6,837,976, 6,942,770, and other US and foreign patents pending. In Touch™ is a trademark of EosHealth, Inc. Copyright 2013 EosHealth, Inc. 09/10/2013 v1.1 86 87 87 88 88 88 Chapter 1 – Your In Touch™ Thank you for choosing In TouchTM your gateway to better management of your diabetes. Your new In TouchTM system will monitor your glucose and your daily physical activity to help you lead a healthier life. This user guide has important information on your new system and how it works. Please read it carefully before using In Touch™, it will help you make the most of your new In Touch™, Your In Touch™ Your In Touch™ is easy to use. It has a color touch screen display which will show your blood glucose, view trends, share with your healthcare team, and view and retrieve personalized messages. It gives accurate glucose test results in just 5 seconds using a very small blood sample. This small sample allows you to use a thinner lancet because not as much blood is needed to do a glucose test. It’s a lot less painful. In Touch™ has a memory that stores your glucose and activity results. It also automatically sends all your data directly and securely to your personalized health account wirelessly. You can also choose to send your results to your healthcare team and receive personalized advice to help you, your coach, and your healthcare professional to manage your diabetes. It even lets you know when you are running out of test strips and need to reorder. But remember, In Touch™ is not intended to provide automated treatment guidance or decisions, nor is it a substitute for your professional healthcare provider. It’s a guide and a helper. Register Your In Touch™ Before you get started, please fill out the Warranty Registration card included in your kit and mail the card back to the address printed on the card, or complete the Warranty Registration online at: www.InTouch.eoshealth.com We use the information collected to improve our service. Contact Us In Touch™ is made by EosHealth, Inc. 2800 Post Oak Boulevard, 4100 Houston, Texas 77056 Inside the USA, please call Customer Service toll‐ free at 1‐800‐945‐4355 or visit our website at: www.InTouch.eoshealth.com Outside the USA, please contact your supplier for support. Important – Staying Safe Please take a moment to read through this important safety information. Remember, this is a medical device and it needs to be treated with respect. The In Touch™ Blood Glucose Monitoring System and lancing device must only be used by one person. For safety reasons, do not share it with anyone, including your family members. Many parts of your device come into contact with your blood. Kit parts can potentially transmit infectious diseases, even after being cleaned and disinfected. Always wash your hands thoroughly with soap and water and dry well after handling the meter, test strips, or your lancing device. Always consult your diabetes healthcare professional and follow his or her guidance about your blood glucose monitoring routine. The recommendations in this manual apply to all blood glucose monitors and are supported by the American Association of Diabetes Educators (AADE), the American Diabetes Association (ADA), the US Food and Drug Administration (FDA), and the Advanced Medical Technology Association (AdvaMed). If this device is used in a manner not specified by the manufacturer, the protection provided by it against hazards may be impaired. The In Touch Glucose Monitoring System is delivered fully assembled and requires no additional assembly. Using This Owner’s Manual We have included some helpful additions to this user manual. These are: NOTES ‐ helpful information for day to day use. CAUTIONS ‐ important tips on protecting your glucometer. WARNINGS ‐ crucial information that will help you use your glucometer safely and crucial information about the risks of receiving inaccurate readings. Chapter 2 – Overview Indications for Use The EosHealth, Inc. In Touch™ Blood Glucose Monitoring System (also known as In Touch™ ) uses an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Fingertip, forearm and palm testing sites should be used alternately only when blood glucose level is not changing rapidly. The In Touch™ Blood Glucose Monitoring System is a handheld device that is composed of a blood glucose meter, pedometer, and GSM cellular radio. The In Touch Blood™ Blood Glucose Monitoring System makes use of its GSM radio to transmit glucometer and pedometer data back to a server and receive information for display in response. The In Touch™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only. • This device is not indicated for the diagnosis or screening of diabetes. 10 • Alternative site testing can be used only during steady‐state blood glucose conditions. • Alternative site testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations. • The In TouchTM Blood Glucose Monitoring System and Strips are to be used with the In Touch™ Blood Glucose Monitoring System; it measures glucose in capillary whole blood from the fingertip, forearm and palm. • For In Vitro Diagnostic Use Your In Touch™ Blood Glucose Monitoring System measures the glucose in your blood and also measures your level of physical activity. Think of it like a health coach who can help you feel your best. You can use In Touch™ at home, or in clinical settings to help you with the management and treatment of your diabetes. Please note that this device is not intended to be used for diagnosis or screening for diabetes mellitus and should not be used with newly born babies. Your In Touch™ takes glucose measurements from small blood samples taken from your fingertip, forearm, or palm. Please note: 11 In Touch™ must only be used outside the body (in vitro diagnostic use). It should only be used with In Touch™ blood glucose test strips and In Touch™ control solutions. It should only be used for testing glucose (sugar) with fresh capillary whole blood samples. It should NOT be used to diagnose DKA or to test newborns. It should NOT be stored in the refrigerator or in the car. WARNINGS: 1. Your In Touch™ contains small parts. Keep it out of the reach of small children and pets. 2. If you have hypoglycemia unawareness, a blood glucose monitor is 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 and other infectious diseases. Handle all parts of your device with care. Wear gloves when performing measurements on another person. Any items that are used to measure glucose like test strips, lancets, and alcohol swabs, must be disposed of safely in accordance with local regulations to avoid the risk of infection. 12 Your Doctor Please us your In Touch™ with care. If you experience symptoms that are not consistent with your blood glucose test results, and you have followed all the instructions described in this User’s Guide, consult your doctor or healthcare professional immediately. It is always better to be safe. 13 Chapter 3 – Components In Touch™ You have everything you will need in your box. Your new In Touch™ device will be ready to go and will already be partly charged. To charge it fully, you will need to plug it in overnight. Under normal operating and blood glucose monitoring conditions, the charge should last for several weeks. You will also find the following: In Touch ™ blood glucose test strips (10). Lancing device and lancets. Control (Normal) solution (1 bottle ). Quick Start Guide. AC charger and USB cord. Warranty card. Carrying case (or a coupon to redeem one of your choice). Glucose Test Strips The In Touch™ Glucose Test Strips are designed for use with your In Touch™ Monitor only. Use each test strip 14 only once, and then discard it. DO NOT reapply blood to the test strip. This is very important. They come in a variety of colors to help you keep track of which you have used, but they all give identical results. They come in vials and also as individually sealed packages with a single test strip. In Touch™ Glucose Test Strips require only a very small blood volume (0.6 µL for glucose) and automatically draw blood into the test area of the strip. They can be handled with clean, dry hands without affecting the readings. They are very convenient whether you test at home or on the go. Important Blood Glucose Test Strip Information Please remember: Use only In Touch™ Blood Glucose Test Strips when testing for glucose. Remove the test strip from the vial/foil only when ready to test. Store the test strip package in a cool, dry place below 86°F (30°C). Do not refrigerate or freeze. 15 Do not store the test strips near heat or moisture. Store the test strips in their original packaging only. After removing a glucose test strip from the vial, immediately replace the cap and close the vial tightly. Do not use test strips beyond the expiration date printed on the package as this may cause inaccurate results. Test strips should only be stored for 3 months after opening. Discard any remaining test strips after this date. Do not tamper with the test strips. WARNING: The test strip vials and packaging contain small parts. Keep away from children and pets. Lancing Device The diagram below shows your lancing device. This is the part of the In Touch™ which takes the sample. To use it, you should: 1. Remove the end cap (A, top left) by gently pushing down and away from the lancing device. 16 2. Insert the lancet (B) firmly into the lancet holder until it comes to a stop. 3. Remove the protective lancet cover (C) by holding the lancing device firmly. Twist and pull off the lancet cover to expose the tip. DO NOT TOUCH THE LANCET TIP. 4. Replace the end cap by snapping it back onto the lancing device. 5. Select the skin penetration depth by turning the depth selector (F) until the desired number can be seen in the depth selection window. The lancing device offers five levels: 1 for soft skin; 2‐3 for average skin, and 4‐5 for thick or calloused skin. 6. Pull back on the lancing device until it comes to a stop. The cocking mechanism will return to its original position upon release. 7. Place the lancing device firmly against your finger and press the release button to obtain a blood sample. The lancet will return to its original position after use. 8. After finishing your blood check, remove the end cap, carefully remove the used lancet, and dispose of the lancet safely in an appropriate container. 9. For alternative site testing, please see Chapter 7. 17 Control Solution Your kit includes a control solution to check your In Touch™ and test strips are working properly. The control solution is a liquid that contains a fixed amount of glucose. It is used to calibrate your In Touch™ and makes sure your readings are accurate. You can also use this solution to practice taking readings, or to check that you are following the correct testing procedure without using your own blood. If the monitor reading is within the control solution’s acceptable range, the meter is working correctly. 18 Chapter 4 – Getting Started Turning On and Setting up your In Touch™ You need to do very little to set up and use your monitor. It will partially charge but your check to make sure that the battery is at least 50% full before using it for the first time. To check the battery status look at the battery gauge icon in the top left of your screen, and the bars within the icon. 19 By lightly pressing the side On/Off button, the Wake‐ Up screen will appear. It will beep for a few seconds as it finds the network and automatically sets the time and day followed by the Home screen. The time and date are set automatically, no matter where you are, and are shown at the top of the Home screen. If you are traveling, In Touch™ will set your monitor’s time to the time zone that you are in so that your measurements will be sent with right time stamp. Having the correct time and date of each blood test result is important because it helps you and your healthcare professional understand your blood glucose 20 patterns and can be used to track changes in your management plan. In Touch™ will also automatically detect the wireless network that you are in and ‘roam’ if necessary. There is no charge to you for roaming or wireless connections. CAUTION: Always handle your In Touch™ with care. Dropping the unit, or exposing it to water for example may damage the sensitive monitoring equipment inside. If you are packing away your unit for an extended period of time, protect it from moisture, prolonged direct sunlight, and extreme temperatures. Look after it, and it will keep looking after you. 21 Your In Touch™ Monitor 1. 2. 3. 4. On/Off button. Color touch display screen. Test strip port. USB charging port. 22 5. Wireless signal indicator. 6. Battery charge indicator. 23 The Display Screen 2. 3. 4. 5. 6. 7. 8. 1. Signal strength. Current date and time. Battery level and charging state. Check your blood glucose level. Trends for information on your performance. Messages you should check. Settings for making sure your device works perfectly. Team to send your information to My Coach, MyMD, MyFamily & MyMobile. 24 Chapter 5 – Checking Your Blood Sugar Before Testing Before testing and to ensure accurate results, wash and thoroughly dry your hands and the testing site. In Touch™ can test blood glucose on the fingertips, forearm, or palm. The sample size is just 0.6 µL (Glu) of blood. This minimizes pain. Safety Tips Follow the cleaning and disinfecting instructions for the meter and lancing device to prevent the risk of blood‐borne pathogens. The meter and lancing device are intended for a single user and should never be shared. Wash your hands with soap and warm water, then dry thoroughly. Alternatively, use alcohol pads to clean the area to be tested and dry it thoroughly after cleaning. NOTE: Cleaning of the puncture site is important. 25 How To Test 1. To save power, the meter will go to sleep when not being used. Power on and wake up the In Touch™ by pressing the ON/OFF button on the right side of the meter, or by tapping the Check/Test icon on the Home screen. When the power comes on you will see: 26 2. You can also wake up the meter by inserting a glucose test strip into the monitor. 3. Press Check, in the top left hand corner. 4. The screen will display “Ready to Check Glucose”. 5. A finger will appear on the screen to prompt you to apply a blood sample. The last blood glucose value and the current steps/calories are displayed at the bottom of the screen. You can cancel the test at any time. NOTE: If the strip is removed before you start the test, the screen will go blank and return to the Home screen. NOTE: If a test is not performed after inserting the test strip, the device will wait indefinitely until the strip is removed or until the test is cancelled. 27 6. Holding hand downwards, massage finger with thumb towards tip to stimulate blood flow. 7. Use the lancing device, loaded with a new lancet, to puncture the finger. (See lancing device instructions for use.) 8. Squeeze the finger to form a drop of blood. Touch the end of the test strip to the blood drop until the test strip is full. While test is in progress, a helpful tip or personal message appears. When you have finished reading the message your results will appear and a beeper will sound if enabled. You will be asked to remove the strip. The test can be cancelled at any time by either removing the strip or pressing the Cancel button. 28 9. The blood glucose result is available on‐screen in 5 seconds. The results will show the blood glucose value and the amount it has increased (+) or decreased (‐) from the last time you tested. While you are waiting for your results, a personalized health tip will appear instead of the usual boring countdown. 29 10. The result is automatically stored into the device’s memory. NOTE: Lancets are for one‐time use only. Use a new, sterile lancet each time you test. Test different areas on your fingertips to avoid developing calluses. Remove the used lancet from the lancing device and follow your local disposal regulations where applicable. NOTE: If the error screen appears, it is most likely due to the sample being too small. The sample has to fill most of the well/channel in the white part of the testing strip. WARNING: Your lancing device is for personal use only. DO NOT share it with others. Sharing the lancing device or lancets can transmit serious infections. To avoid accidents, do not store used lancets in the device after testing and do not load the lancing device with a new sterile lancet unless ready to use. 30 NOTE: Do not press the test strip directly against the skin. Touch the test strip gently to the blood drop. 11. After your blood glucose is displayed on the screen, you can quickly and easily tag your blood glucose result with important information as follows: Mealtime Tags The first screen that appears is the Mealtime screen. Select by tapping the button and selecting the meal at which the blood glucose was taken. Once you have selected the meal, it will be highlighted. If you selected any of the “After” meals, the “Add Carbs” will be highlighted. By tapping “Add Carbs”, a keypad will appear where you can add the carbs for that meal. The numbers will be highlighted on selection and will 31 register in the counter box. If you do not want to tag carbs with your blood glucose, just press NEXT at the bottom right of the screen. You can always go back and change your selection by tapping the BACK button. If you use insulin and have set up your profile on the web portal (see below), or on your In TouchTM (in settings), you can log both your Carbs and your Insulin dose. Immediately following your results, the screen will show “Add Carbs/Meds” which will take you to a screen where you can add your mealtime Carbs and Insulin dose, by pressing Carbs or Insulin at the top of the display. The keypad will let you type in your records for Carbs and Insulin. Feeling Sometimes you may want to quickly add some other helpful notes to your blood glucose data including how 32 you feel, whether your blood glucose reading follows exercise, or whether it is with or without medication. These selections are all at your fingertips and can be chosen from a pre‐selected list on the In Touch™ display screen (your website will give you additional opportunities to add notes). If you are feeling fine, for example, just tap to record this as part of the data that is automatically recorded in your logbook and transmitted to your health account. These notes can be helpful for both you and your healthcare provider to understand any patterns that might arise with mealtimes, medications, exercise, or other factors. 33 Changing Your Selections 12. When you are finished and the tags are completed, you will be asked to confirm the information before it is sent securely to your health account. Before transmitting the data, you can always go back and change your previous selections by pressing the Back button and re‐selecting from the quick‐add menus. 13. If the reading is high or low, or if there is another issue, you may be prompted to test again. 14. Your results and tags can be found in your health account within a minute; from there, you can send data directly to your coach or healthcare team. 15. You can also view your results online at: www.InTouch.eoshealth.com 34 16. When your results have been successfully transmitted, you will receive a tip or personal message from your coach or healthcare team. 35 If Data Transmission Is Unsuccessful If there are only one or two bars of wireless signal strength on your device, it may result in unreliable transmission or reception of your data. The signal strength indicator is located at the top of the In Touch™ screen. If the device cannot communicate with your secure health portal, the following message will appear: “No data connection, data will be stored and transmitted as soon as a secure connection is detected.” 36 In this case, your results will be stored and automatically transmitted once a sufficient signal is acquired. You do not need to do anything since this will happen automatically once a reliable signal is obtained. If the data transfer fails, In Touch™ displays the blood glucose on its screen just like any other glucose meter. The results will also be stored in the memory and can be reviewed in the Trends section. IMPORTANT: If your blood glucose level is above 600 mg/dL or below 20 mg/dL, re‐check your blood glucose immediately using a new test strip. DO NOT re‐check on your palm or forearm but using your fingertips. If you still receive the same value, call your doctor or healthcare professional immediately. 37 Chapter 6 ‐ What Do Your Results Mean? Your blood glucose value will vary according to your food intake, your medication, your general health, your stress levels, and your level of physical activity. To give you an idea, the ideal ranges for people without diabetes are as follows: 70 to 100 mg/dL before meals, and 70 to 140 mg/dL after meals. Blood Sugar Test results greater than 250 mg/dL may mean high blood sugar (hyperglycemia). Test results lower than 60 mg/dL may mean low blood sugar (hypoglycemia). High Or Low Readings If your In Touch™ displays results that are more than 250 mg/dL or below 50 mg/dL AND you feel ill, treat your diabetes according to your doctor’s instructions. If your In Touch™ displays results that are more than 250 mg/dL or below 50 mg/dL and you DO NOT feel ill: 38 Test your In Touch™ with a control solution (see section 4). Wash your hands, dry thoroughly, and test again using your fingertip. If you still get a high or low reading, you should contact your doctor. References American Diabetes Association Standards of Medical Care in Diabetes ‐ 2008. Diabetes Care ‐ 2008; 31: S12 –S54. 39 Chapter 7 – Forearm & Palm Testing In Touch™ allows you to check your blood glucose on alternative sites with the same accuracy as on your fingertips. The In Touch™ reduces the pain of blood glucose monitoring significantly by requiring only 0.6 µL of blood sample. How To Test 1. Select the forearm test site in the highlighted area as shown in the diagram below or, alternatively, select the palm heel or palm side test site. 2. Attach the clear cap to the lancing device. Press and hold the lancing device FIRMLY against the forearm or palm. 3. Continue to hold FIRMLY and press the release button to lance the area. 40 4. Continue to hold the device, pressing FIRMLY until a full blood drop forms. The clear cap allows you to see the blood drop. 5. Apply the blood drop to the edge of the test strip so that the blood is drawn into the strip. 6. Hold the monitor to the blood drop until you hear a short beep or until you see the monitor begin to count down. NOTE: The blood on the strip should look similar to the red blood you are accustomed to seeing when you test your finger. If the sample looks clear, pink, or light in color, retest with a fingertip sample. 7. Your blood glucose test result is displayed on the screen and stored. Limitations & Considerations Some people check their blood glucose at sites other than the finger because it is generally less painful. However, there are circumstances when these other sites can give different results to the finger. Results from the forearm may be different from fingertip results when glucose levels are changing rapidly, e.g. after a meal, after taking insulin, or during or after exercise. Only use finger or palm checks during these times. 41 CAUTION: Always seek the advice of your doctor or healthcare professional before choosing to use forearm and palm sites. Bruising may occur with forearm and palm testing. Don't Use Forearm Checking For at least 2 hours after you have eaten or injected insulin. If you have recently exercised. If you think that your blood glucose is low. If you think that your blood glucose may be changing rapidly (e.g. after a meal, after taking insulin, or during or after exercise). If you are unaware of symptoms when your blood glucose is low (hypoglycemic). If your forearm results do not match the way you feel. In this case, recheck using your finger or palm. Forearm Checking Might Not Be Appropriate If you are ill. If you are under extra stress. If you routinely have widely fluctuating blood glucose values that are often low (hypoglycemic). If values from the palm sample were shown to be equivalent to values from the finger samples. 42 Chapter 8 – Viewing Results and Trends Your In Touch™ stores 500 records in its on board memory. This gives you a convenient view of what’s been happening. There is a quick and easy way to review your results: Tap the Trends icon on the home screen. Under Trends, you can view your Logbooks, Mealtime Values, Trends, Patterns & Statistics, and Activity. You can also get a Snapshot Summary of health from your secure personal health account. Your personal health results and some helpful personalized advice based on your readings can be found in your personal health account at www.InTouch.eoshealth.com. 43 Logbook Your Logbook is an overview of your recent records. It will show you results from the last 7 days.You will see the Day and Mealtime, (“Before” and “After”) in relation to your blood glucose. The most recent 7‐day values will appear first. To get more detail, you can tap on the Day button to display an expanded view for the selected day. The apple indicates whether it is before (whole) or after a meal (eaten). Mealtime Values To get a Quick View of the mealtime values, In Touch™ will display blood glucose values and trends for Breakfast, Lunch, Dinner, or Bedtime (Snack) in tabular or graphic form for each of the meals. 44 By tapping the B, L, or D on the top bar of your Logbook, you can view the mealtime values for the week or for a period of up to 30 days. High or low values are highlighted in red and those intermediate or borderline values in yellow. Carbs and additional Notes (e.g. Feelings) will be displayed in these tables. Tapping on the Day button in the far left‐hand column will display an expanded view of the Mealtime Logbook. 45 Patterns & Stats In Touch™ also provides Quick Views of patterns and statistics, displaying (7, 14, and 30 day) averages, high, lows, percentage variability, and percentage of your blood glucose values within your set targets. You can view for ALL, B, L, D (Breakfast, Lunch, and Dinner), and whether before (apple) or after (eaten apple). Tapping the B, L, or D at the top of the bar displays the breakdown for that mealtime and shows an average over 7, 14, 30, or 90 days to identify any trends. 46 It is also possible to view your High or Low values, in total or at specific mealtimes, together with other notes, to see if there are patterns that affect your blood glucose level. 47 Steps and Calories Your In Touch™ automatically records your steps and the number of calories you burned to your personal health account. Your results for the week can be displayed by tapping the Activity button. Like your blood glucose results, your activity results are displayed by the week. You can tap on the day to get an expanded view as well as the steps for that day (Daily Steps). 48 49 Snapshot Summary In Touch™ will provide an updated 30‐day snapshot of your health metrics including blood glucose, glucose goals, running Hb1Ac, Variance (how much your blood glucose value fluctuates in the 30‐day period), Steps, and Net Calories gained (+) or lost (‐). 50 Chapter 9 – Your Messages Messages Your In Touch™ also provides two‐way messaging and has the ability to retrieve and store messages and personalized tips. The Message Icon on the home screen will display how many new and unread messages you have waiting in your Inbox. To view your messages, tap the Message icon on the Home page. Messages include reminders, health tips, and important communications from your health team. You can retrieve messages placed in your account from your health team, your coach, or your doctor. One of the innovative features of In touch is that you will be notified when you are close to running out of blood glucose strips. We make it easy: when you are about 5 days away from running out, the automatic messaging will ask you if you would like to re‐order. 51 If you do, then the supplies will be sent directly to the address you have in your account. And you will be notified that they have shipped, all on your In Touch. This is the easiest way to stay stocked up. Team In TouchTM can send your results directly to your Team: your health coach, MD, family mobile phone or email. By simply tapping MyCoach or MyMD, your personal health record will be faxed or emailed to the number or address you provided when you registered. For example, if you tap MyMobile, your 30, 90, and 120 day summary will be sent to your mobile phone as a text message or email. 52 MyCoach By tapping the MyCoach icon you can send your results directly to your coach and set up a coaching session. MyMD 53 By selecting MyMD, you can share your results with your MD. If you have placed your doctor’s fax number when you registered or on the website, the results will be automatically transmitted to that number. 54 If you have not registered, a keyboard will appear where you can enter your doctor’s fax number to send your results. You only have to enter this only once as it will be stored in your personal health account. MyFamily MyFamily enables you to select a member of your family with whom you want to share your results. They will get your results by text on their mobile phone, email, or by a telephone call. You and they can choose how they want to best get your results. This is ideal for checking up on kids who are in school so that mom and dad don’t have to call the school to get the results. You can choose when and how to share the information, and everything is sent securely. 55 MyMobile MyMobile allows you to send records directly to your mobile phone for easy viewing. NOTE: When the monitor memory is full (500 test results), the oldest resultwill be deleted from the on board memory. You won’t lose any data because In TouchTM will confirm that the oldest result is already logged in your secure Web health account. 56 Chapter 10 – Your Personal Web Portal Your test results and personal information are stored securely in your online health account and can be viewed by visiting: https://www.eoshealth.com/intouch/ Logging In You will need to enter your User ID (usually your email address) and the personal identification number (PIN) you specified when you first registered. 57 Dashboard When you log in, the first screen you will see is your BG Dashboard, which will let you view your results for today or for the last 7, 14, 30 or 90 days; you can also create a printout. The Dashboard shows you at a glance your average blood glucose level within your chosen timeframe, your highest and lowest levels, how many strips you have used and how well you are sticking to your testing routine. More Detail Clicking on the dropdown lists also lets you see: When you will need to reorder more test strips. 58 Your health log, with tagged meal readings. Your latest glucose readings. Meal patterns and stats. Trends. Averages. Your In Touch™ messages. Your online health account also has pages where you can see all your data (and filter it if required), change your clinical settings, change your profile details, and access In Touch™ support. 59 Chapter 11 – Checking Your In Touch™ The Control Solution Test The control solution test confirms that your monitor and test strips are working correctly. A control solution test is similar to a blood test, except that you use In Touch™ Control Solution and not a blood sample. You should run a control solution test: When you first get your monitor and then at least once a week. Each time you open and begin using a new vial of glucose test strips. If you leave the glucose test strip vial cap open for any length of time. If the monitor is dropped, damaged, or exposed to liquids. If you think your test results are inaccurate or if your test results are inconsistent with how you feel. To check the performance of the monitor and test strips. NOTE: High and Low Glucose Controls are also recommended as an additional quality control check 60 for your In Touch™ monitoring system. These can be purchased from your dealer. Using Control Solution Use only genuine In Touch™ Control Solution to check. Check the expiration date on the control solution vial. Do not use control solution past the expiry date or you may get inaccurate results. The control solution will remain accurate for 3 months after first opening. Discard any remaining solution after this date. Store the control solution, tightly closed, at room temperature below 86°F (30°C). Do not refrigerate or freeze the control solution. Shake the control solution well before using it. CAUTION: The In TouchTM Glucose Control Solution ranges printed on the test strip vial and foil pouch are for the control solution only and are used to test the performance of the monitor and test strip. If your Control Solution Results continue to fall outside the printed range: The In Touch™ Monitor may not be working properly. Do not use the monitor to test your blood. 61 Inside the USA, call Customer Service at 1‐800‐945‐ 4355. Outside the USA, contact your supplier. Checking your In TouchTM 1. Press the ON/OFF button on the side and go to Settings > Calibrate > Control. 2. Insert a strip into the meter. NOTE: If the strip is removed before you start, the screen will go blank. If a control is not performed within 2 minutes of inserting the strip, the screen will go blank. To check, remove and replace the strip, starting from Step 1. 3. Shake the control solution vial. Discard one drop before use. Squeeze the second drop of control solution onto a clean, hard, dry surface, i.e. the 62 control cap. 4. Go to the Settings section and select Calibrate > Control. 63 5. Pick up the meter with strip inserted and touch the strip to the drop of control solution. 6. A quality control result is available on‐screen in 5 seconds for glucose. 7. Compare the result on the display with the range printed on the strip vial or foil pouch. If the result falls within the range, your monitor and strips are working correctly. 64 8. The result is automatically stored into the device’s memory, is marked and sent to your health record as a control sample. You can review your controls within your health record. Control Solution Troubleshooting Out‐of‐range results may be caused by the following: An error may have occurred when performing the control test. Try another test and remember to follow the instructions carefully. The control solution may have expired or may have been contaminated. Check the expiration date on the control solution vial. Control solution is only good for 3 months after opening. Make sure the control solution vial is closed when not in use. 65 The strip may have expired. Check the expiration date on the test strip vial. The test strip may have been damaged. This can be caused by extreme temperatures or by leaving the test strip vial cap open. Try another test using a new test strip. There may be a monitor malfunction. Call Technical Support at 1‐800‐945‐4355 (inside the USA). Outside the USA, contact your supplier. Important Tips Use only In Touch™ Control Solution with the In Touch™ Strips. Other brands of control solution or test strips will produce inaccurate results. Always check the expiration date. Do not use expired control solution. Do not freeze. Store the control solution closed and at room temperature. Never touch the tip of the control solution bottle to the test strip; this will contaminate all the remaining solution in the bottle. NOTE: If the control solution test result is outside the range (is either higher or lower), your monitor and test strip may not be working together properly. Repeat the process using a new test strip. WARNING: Do not use the monitor for medical purposes until your control solution test results fall within the appropriate range. 66 67 Chapter 12 – Maintenance Cleaning The exterior of the In Touch™ Monitor should only be cleaned and disinfected with DISPATCH Hospital Cleaner Disinfectant TowelsTM. These have special ingredients that clean and disinfect your In TouchTM. Clean and disinfect your meter at least 1 time per week using DISPATCH Hospital Cleaner Disinfectant TowelsTM. using the procedure below. Liquids should not enter the test strip port. 1. Dispense the DISPATCH Hospital Cleaner Disinfectant TowelsTMfrom its package or container. 2. Clean the outside of the meter to remove any blood or dirt. 3. Discard used towel in a sealed container where it will not be touched by others. 4. Dispense a second DISPATCH Hospital Cleaner Disinfectant TowelsTM from its package or container. 5. Discard used towel in a sealed container where it will not be touched by others. 6. Wait at least one minute and make sure device is 68 completely air dried before checking your blood glucose next. 8. Disinfect the meter with the second towel by wiping all outside surfaces. In TouchTM has been validated for 1,825 cleaning and disinfection cycles or once the lifetime of the device (5 years) has been reached, whichever comes first. Battery The monitor is powered by a rechargeable battery. If this battery begins to lose charge, a small icon will appear near the battery power icon in the upper left corner of the screen to warn that the monitor has sufficient charge for 20 more tests. Continue with testing as usual; the battery warning will remain on‐screen. 69 When charging using the USB charger, you will not be able to use In Touch™ to do any checking. Unplug the charger from the wall before checking. The display screen will also show how In Touch™ is charging. After 20 tests have been performed, there will be insufficient battery charge to continue testing, and the monitor will no longer operate. If you notice significant reduction in the duration of your meter’s operating time, your meter may need replacing. Please contact In Touch™ technical support at (888) 666‐4530, or e‐mail support@.com. 70 Storing Your In Touch™ & Strips Your meter is a delicate electronic device that should be handled with care. Severe shock, such as that caused by dropping the meter, could damage it. The meter and test strips only work in the temperature range of 50˚F to 104˚F. Store the test strips between 39°F and 86°F. Do not freeze. See the test strip instructions for more details. Don’t leave the meter in a place that is extremely hot or extremely cold (e.g. anywhere near a heat source or in an extremely hot or cold car). Do not expose the meter or test strips to high levels of humidity, such as in the bathroom or kitchen. Immediately close the bottle cap tightly after removing a test strip. 71 CAUTION: DO NOT attempt to open the monitor to make any repairs. Your warranty and all claims will be void! Only authorized service personnel can repair the monitor. If you have any problems or questions, turn your meter off and contact In Touch™. Inside the USA, call Customer Service at 1‐800‐945‐4355. Outside the USA, contact your supplier. Support is available Monday through Friday, 9AM ‐ 5PM EST. 72 Chapter 13 Settings Options Help Your In Touch™ comes with an interactive Help menu, digital FAQs and an abbreviated User’s Manual. This means you can get help directly from your device, wherever you are. About The about menu contains important information about your In Touch™ device including the version number, transmitting module ID number, and the 73 wireless card, all of which can be used to troubleshoot any issues you might have. Airplane Mode Turning on the Airplane Mode disables your cellular network access, and you will not be able to transmit your readings while it is turned on. This is useful if you are taking off or landing during a flight. Your meter’s clock will, however, continue to work properly in this mode and will reset when Airplane Mode is turned off. You can still use In Touch™ just like any other glucose meter and when you access the cellular network your values will be automatically transmitted to your health account. 74 Meds In TouchTM has a built in insulin logbook to help you record your insulin dose. To do this, simply tap the Meds and set it to Insulin Y/N, and your In Touch will prompt you, should you wish, to record your insulin dose at specific times. Activity Monitor Settings These settings allow you to tailor your stride and step information, as short, medium, or long strides. This can help you get more accurate results which reflect your body shape. 75 Reminders Your In Touch™ has a reminder function that will sound or provide a message on the screen. It is pre‐set to “On”. This tells you when enough blood is applied to the t strip, when checking is completed, when you have a message waiting; if enabled, it also prompts you to carry out other steps using your monitor. You can create up to three reminders to tell you when to check or take medications. You can set the times by tapping the time and the AM or PM, and also set the day of the week. Calibrate Control This function allows you to test the meter and test strip functions using a control solution to make sure that they are working properly. 76 77 78 Chapter 14 ‐ Troubleshooting Issues With Tests If your device does not begin checking after you have inserted a blood sample, you should check if: • The test strip is upside down or is not inserted fully. • The battery is dead. • You have taken enough blood to sample. • Your In Touch™ has automatically turned itself off. • The test strip may be damaged. • Your In Touch™ may not be working properly. Basic Troubleshooting 1. Insert the test strip correctly with the name and white tip facing up and out. If you are still having issues with tests: 2. Repeat the test with a new test strip. 79 After 3 attempts, call 1‐800‐945‐4355 (inside the USA). Outside the USA, contact your supplier. Error Messages In the event your device experiences an error, you will see the following screen along with an error message. Error Message: “Meter Failure” What it means: As with any computer device, sometimes the meter may need to be restarted. Action to take: Restart meter and contact In Touch™ support if the problem continues. Turn your meter off before calling In Touch™ on 1‐800‐ 945‐4355 Error Message: “Used Strip Inserted” What it means: Your test strip may be used or damaged. Action to take: Repeat the test with a new test strip. Remember to add the sample only when you see the prompt on the display screen. If you believe that you have received a damaged test strip, return it to In Touch™ for a free replacement. Error Message: “Not Enough Blood” 80 What it means: There is not enough blood or too much blood or control solution on the test strip to give a reliable reading. Action to take: Remove the test strip and repeat the test with a new test strip. Error Message: “Temp. Too Low / Temp. Too High” What it means: The meter is too hot or too cold. Action to take: Move the meter into an area that is between 50˚F and 104˚F. IMPORTANT: After receiving this error, allow the meter to be at room temperature for at least 30 minutes before testing blood or control solution. Communication Errors Error Message: "No data connection, data will be stored." What it means: The meter cannot find a cellular connection. Action to take: See “Communication Errors” below. If you are having trouble uploading your results to In Touch™, you may want to try the following: • If you are testing indoors, move closer to a window for better cellular reception. 81 • Try testing outdoors. • Check to see if there is cellular coverage in your area. Two bars or less of wireless signal strength may result in unreliable transmission and reception of data. • Restart the meter. Getting Support If you still can't resolve your problem, turn your meter off and contact our In Touch™ technical support on: 1‐800‐945‐4355 support@intouch.eoshealth.com 82 Chapter 15 – Specifications and Limitations Specifications Test Measured Blood Glucose Glucose Methodology Glucose oxidase biosensor Glucose Test Results mg/dL (Plasma values) Sample type Capillary whole blood Glucose Test range 20 to 600 mg/dL Acceptable Hematocrit range 25% to 60% Length of Test 5 seconds (Glu), 10 seconds (Ket) Test Strip Volumes 0.6 µL (Glu) Operating Ranges Temperature: 57° to 104°F (14° to 40°C) Humidity: 10% to 90% relative humidity Altitude: up to 10,000 ft (3000 m) Weight: 2.65 oz (75 g) Size 3.6x2.3x0.9 in (91.4x58.4x22.9 mm) Monitor data storage: 500 results Electrical & Power Ratings Electrical Specifications: 3.7V Li‐Polymer Battery 1100mAh Maximum current (Battery): 650mA peak 83 Maximum power (Battery) : 2.4W peak Maximum current (USB input, charging): 1A continuous USB charging input: 5V 1A Glucose Test Imprecision 6% or 5.4 mg/dL (whichever is greater) Environmental • The storage temperature range for the monitor: ‐13°F to 115°F (‐25°C to 46°C). • The storage temperature range for the test strips: 59°F to 86°F (15°C to 30°C). • The monitor operational temperature range: 57°F to 104°F (14°C to 40°C). • The relative humidity range: 10% to 90% non‐ condensing. Limitations The test strips give accurate results when the following limitations are observed: The test strips should not be used to diagnose diabetes, DKA, or to test newborns. Each test strip is for a single test only. Do not reuse the strips. Use a new, sterile In Touch™ test strip each time you test. 84 Your test strips are for personal use only. Do not share them with any people, including relatives. Use only fresh capillary whole blood. Do not use serum or plasma. There is no effect on blood glucose for altitudes up to 10,000 feet (3000 meters) above sea level. Refer to the Owner’s Guide for operating temperature range for the monitor. Extremes in humidity (higher than 90% and lower than 10%) may affect results. The In Touch Test Strips are calibrated against plasma. The anticoagulant sodium and lithium heparin may be used. EDTA is not recommended for use with In TouchTM Test Strips. Interferences for elevated levels of acetaminophen, tolazamide, uric acid, bilirubin, ephedrine, and methyldopa may affect results. Glucose test results may be falsely low if the patient is severely dehydrated. Critically ill patients should not be tested with the In Touch™ Global Glucometer. 85 Chapter 16 – Warranty and Compliance Your In Touch™ is guaranteed to be free of material and workmanship defects for 3 years from the date of purchase (except as noted below). If at any time during the first 3 years after purchase, your In Touch™ does not work for any reason (other than as described below), it will be replaced with a new monitor or a substantial equivalent, 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 which 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 In Touch™ Monitor when used with test strips other than Nova Test Strips. Therefore, we make no warranty as to the performance of the In Touch™ when used with any test strips other than Nova Test Strips. There is no other express warranty for this product. The option of replacement, described above, is the warrantor’s only obligation under this warranty. 86 For Warranty Service The original purchaser must contact Customer Service at 1‐800‐945‐4355 if in the USA. Outside the USA, contact your supplier. FCC Interference Statement 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. Using 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 of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. 87 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC Caution Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. FCC Radiation Exposure Statement This equipment complies with FCC Radiation Exposure Limits for an uncontrolled environment. This transmitter must not be co‐located with or operating in conjunction with any other antenna or transmitter. Privacy Policy As the manufacturer of In Touch™, EosHealth is committed to using your personal information respon‐ sibly 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 a better service for you in the future. 88 89
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