Gocap System User s Guide

Transcription

1 Gocap System User s Guide

2 Hello! This User's Guide will help you get started using Gocap. Gocap is an aid to help you in effective management of your diabetes. Before you begin using the Gocap system, please read this User s Guide carefully. The Gocap system is an accessory for insulin pens. The Gocap is intended to automatically log and view injectable insulin dose behavior for people with diabetes and healthcare professionals.

3 Contents Introduction What s in the Box System Requirements Safety Instructions Intended Use of the Gocap System Support Gocap Basics A Look at the Gocap The Gocap Display Screen The Gocap App Setting Up and Using the Gocap Before You Begin Setting Up the Gocap Using the Gocap Setting Up and Using the Gocap App Setting Up the Gocap App Troubleshooting Connection Problems Setting Up Multiple Gocaps Using Different Types of Insulin Changing Modes on the Gocap About the Gocap App Using the Gocap App

4 4 Contents (continued) Viewing Recent Activity on the Timeline Screen Working with Logbook Entries Working with Graphs Adding a Device Sharing Your Gocap Information with Others Setting Up Gocap Alerts Setting Up a Dosing Schedule Recharging your Gocap How to Recharge Your Gocap Caring for Your Gocap Cleaning Your Gocap Troubleshooting Gocap Problems Handling Gocap Problems Handling Unread Doses Handling Other Problems Disposing of Your Gocap Gocap System Technical Specifications FCC Notice About Common Sensing Warranty Information

5 Introduction What s in the Box Gocap 2 AC Power Adapter 3 Micro USB Cable 4 User's Guide 5 Quick Start Guide System Requirements The Gocap system must be used with one of these brands of insulin pens: Lantus SoloSTAR Apidra SoloSTAR

6 6 The Gocap App must be used with one of these smartphones and operating systems: Apple iphone or ipod Touch device running ios iphone 4S or higher Android mobile phone running Android OS minimum 4.1 (Gingerbread) API level 16 For more information about compatible devices and operating systems, visit Safety Instructions Remember these important safety instructions as you use the Gocap system. WARNING: Never use the Gocap system to make insulin dosing decisions. The Gocap App may not always be updated with your most recent dose information, or its display screen reading may not correspond with the number of insulin units your insulin pen injected into your body. If you are unsure of a dosing decision, contact a medical professional for assistance.

7 Always check the type of insulin you are dosing. Gocap is not a blood glucose monitor. Always follow your doctor's instructions for making any dosing decisions. If you are unsure of a dosing decision, contact a medical professional for assistance. Misdosing can lead to hypoglycemia. The Gocap system does not provide real-time communication with any persons you may invite to share your information. The Gocap system is not intended for use as a dose monitor for critical care. 7

8 8 Intended Use of the Gocap System The Gocap system is intended for use to aid logging and viewing injectable insulin dose amounts by people with diabetes and by healthcare professionals. The Gocap system s additional features include pushing medication reminders and other notifications, providing safety alerts, and transmitting reading data to the appropriate medical data servers for data review and analysis. The Gocap is not on the insulin pen during injection, and it is not intended to affect the safety and efficacy of existing dosing processes with an insulin pen. Support For help, visit the Gocap support website at help@gocap.me, or call

9 Gocap Basics 9 The Gocap system works with insulin pens to create an automatic and shareable logbook of your insulin doses. This logbook can be conveniently stored on your smartphone using the Gocap App. The Gocap replaces the plastic cap that comes with an insulin pen. Each time you use the Gocap, it stores information about the dose. You can use your Gocap by itself, or you can use it in combination with the Gocap App installed on your smartphone. If you use just the Gocap by itself, you can see a reading of insulin remaining and doses taken on the Gocap s display screen. If you also use the Gocap App, the Gocap uploads its stored information to the Gocap App. Then you can use the app to view all of your stored information. You can also use the app as a logbook for other information you enter directly, like information about a meal or a glucose reading. The Gocap App can also remind you when it s time to take a dose or let you share information directly with your healthcare provider, family member, or friend.

10 10 A Look at the Gocap Port for Inserting Insulin Pen 2 Insulin Pen Type Indicator Light 3 Display Screen 4 Charge Indicator Light 5 USB Charging Port 6 Rechargeable Battery (inside, non-replaceable) The Gocap Display Screen Insulin meter 2 Syncing icon 3 Dosing schedule

11 The Gocap App 1 1 Gocap App navigation menu 2 Gocap App logbook screen 11 2

12 12 Setting Up and Using the Gocap The Gocap replaces the plastic cap that comes with an insulin pen. Follow the steps in this section to set up your Gocap. Before you Begin Before you begin using the Gocap system to record your insulin doses: Read this User s Guide carefully. Decide whether you are going to use the Gocap by itself, or whether you want to use the Gocap App on your smartphone as well. Take all of the Gocap components out of the box and look them over. See the Quick Start Guide included in the box for an introduction to the components of your Gocap and an overview of the setup process.

13 Setting Up the Gocap 13 The Gocap comes with a removable Reminder label. Read the warning on the label. Then remove the label. Remove the cap from a new insulin pen. Push the insulin pen into the Gocap and turn until you hear a click. The Gocap takes the place of the cap that came with the pen. The Gocap is now ready to use. CAUTION: Once you have placed the Gocap on an insulin pen, always store and use the pen in accordance with the insulin pen manufacturer s instructions.

14 14 Using the Gocap When it s time for you to dose, follow these steps. 1 Check that your insulin pen is in the Gocap. To log a dose, you need to start with your pen inside the Gocap. 2 Remove the Gocap, and take your dose. 3 Follow your doctor s instructions for dosing.

15 15 4 Put your insulin pen back in the Gocap. Push the insulin pen into the Gocap and turn it until you feel the pen click. When the pen clicks, Gocap can read your dose properly. If you don t hear a click, Gocap can t read the dose. A light flashes on the Gocap to indicate it is reading the pen, and flashes quickly after the dose was read. If you don t see a flashing light, push and turn the pen again. Leave the Gocap on your pen until your next dose.

16 16 After you compete a dose, the Gocap display screen will add a check mark for each dose you take in a day. You can see up to three check marks at once. Note: If you set up a dosing schedule using the Gocap App, your Gocap will start showing a blinking circle one hour before the time selected in the dosing schedule. Note: The insulin meter shows how many units are left in your insulin pen, rounded to the nearest 10 units. If you dose a small amount, the dose meter may not change. To see your logged doses, check the logbook entry in the Gocap App (if you are using the Gocap App). Note: If you purge insulin from the pen before taking a dose, the amount you purged will be included in the dose amount.

17 Setting Up and Using the Gocap App 17 If you want to use the Gocap App, follow these steps to set up the Gocap App. 1 Install the Gocap App on the smartphone you want to use. The Gocap App is free to download and install. Choose the appropriate download for your smartphone. For Android Devices Go to the Google Play Store on your phone. Search for Gocap. Download and install the Gocap App. For iphone Go to the Apple App Store on your phone or device. Search for Gocap. Download and install the Gocap App. 2 Set up your Gocap account. Open the Gocap App. The Gocap screen displays.

18 18 Tap the I m a patient button on the Gocap screen. The Welcome! screen displays with a Get started button. Tap the Get started button. The Get started screen displays. Enter your address and a password on the Get started screen, and then tap the Ready button. The Gocap App signs you in and the Connect your Gocap screen displays.

19 3 Set up the Gocap's connection to your smartphone. Plug one end of the micro USB cable into the port on the tip of your Gocap, plug the other end into the AC power adapter, and then plug the power adapter into a wall outlet. You can also plug your USB cable directly into a laptop or desktop computer, but make sure the computer is not in sleep mode. Plugging the Gocap into a USB power source switches the Gocap into connection mode. The charging light on the Gocap should be either red or green. Make sure the Connect your Gocap screen displays on the Gocap App. Place your smartphone near your Gocap. Tap Ready on the app screen on your smartphone. The Connecting screen displays. Your smartphone will display a confirmation dialog to confirm that you want to pair your Gocap. Tap Pair or OK on the dialog. The Success! screen displays. 19

20 20 If your Gocap does not connect successfully, an error message displays about Sorry, couldn t connect with your Gocap. If you see this error message, see Troubleshooting Connection Problems (Page 22) for help.

21 Notes If you plug your USB cable directly into a laptop or desktop computer, the computer should be turned on and not in sleep or standby mode. The charging light on the Gocap should be either red or green. If you are using an iphone, make sure Bluetooth is turned on in the Settings menu. 21

22 22 Troubleshooting Connection Problems If you see error messages about your Gocap being unable to connect with your smartphone, try these steps to resolve the problem. Make sure the Gocap is within 10 feet of the smartphone. Make sure the Gocap is plugged into a USB power source. If you use an iphone, check the iphone Settings menus to make sure Bluetooth is set to On. Try an alternative method of connecting. In the Gocap App, tap Devices on the top navigation menu and then tap Add a device (You may need to swipe left on the top navigation menu.) The Gocap and the Gocap App will automatically try to connect again. Check the list of supported telephones on the Gocap support site at to confirm that your smartphone is supported.

23 Setting Up Multiple Gocaps 23 If you want to add another Gocap, first tap the Add a Device button, and follow the setup instructions. For more information, see Adding a Device (Page 36). CAUTION: Always use Gocap with one insulin pen at a time. For best results, always start with a new insulin pen, and use until completion before starting another. If you are using two Gocaps, never swap insulin pens. Using Different Types of Insulin Your Gocap can log doses from Lantus pens right out of the box. If you want to use an Apidra pen with Gocap, you must first switch Gocap from long-acting insulin mode to fast-acting insulin mode. See Changing Modes on the Gocap (Page 24) for more about inserting and removing insulin pens.

24 24 About the Gocap App The Gocap App lets you work with your stored insulin dose information in several ways: You can view a detailed chronological log of doses, or you can see graphs of activity. You can add information manually to your logbook. You can share your information with others. The Logbook screen displays all of your logged activity, with your most recent activity at the top. Notice that there are six different color-coded types of log entries (one color each for fast-acting insulin, long-acting insulin, meals, glucose, alerts, and unread doses). Be sure you understand what each color stands for. For more about unread dose and new pen log entries, see Dealing with Unread Doses (page 58).

25 25 Using the Gocap App To use the Gocap App, sign in with the user name and password you created when you set the Gocap system up. After you have signed in, you can do the tasks listed below. This section explains how to do each task. View recent activity on the Logbook screen Work with logbook entries (add, edit, or delete an entry) Add an additional Gocap Share your Gocap information with others Set alerts and set up your insulin dosing schedule

26 26 Viewing Recent Activity on the Timeline Screen 1 Swipe up or down to view the detailed logbook of specific dosing and timing information. Note: If the alerts function is turned on, alerts and notifications appear on this screen about missed doses, temperature alerts, etc. 2 Tap a logbook entry to view more details about that entry. Note: There may be graphs visible on the details screen. For more information, see "Working with Graphs" (Page 32). Working with Logbook Entries You can manually add a logbook entry, or delete an existing logbook entry.

27 Adding a manual logbook entry You can choose among logbook entries for glucose readings, meals, and insulin doses. 1 Tap Logbook on the top navigation menu. The Logbook screen displays, with the button. 2 Tap the button to add a new entry. The Add menu displays. 3 Tap the button for the type of activity you want to log. A log entry screen displays for your choice. 27

28 28 4 Enter your information in the appropriate fields on the screen. 5 Tap Save to save your log when you are finished. Note: If you tap the back arrow in the top left corner, your information will not be saved and the log will be deleted.

29 Deleting a logbook entry You can delete any logbook entry, whether it was uploaded from the Gocap or entered manually. Follow these steps to delete an entry. 1 Tap Logbook on the top navigation menu. 2 Tap the entry you want to delete in the chronological display of entries. You may need to scroll through the list to find the entry. 3 Tap Delete on the Log details screen. The Delete button changes to Confirm? Tap Confirm? to delete the entry. 29

30 30 Working with Graphs You may see graphs of the information in your logbook by selecting one of the logbook entries. 1 Tap Logbook on the top navigation menu. 2 Tap the entry you want to view graphs for. Scroll up and down the entry details screen to view the graphs related to that entry type. The number of graphs available is based on the number of entries in your logbook. As you enter more information, more graphs will be available.

31 Note: Some graphs are based on the dosing schedule feature. To see all of the graphs, you will need to set up your dosing schedule. For more information, see "Setting Up a Dosing Schedule" (Page 44). 31 Here are all of the possible graphs and what they show you: Fast-acting on schedule How many fast-acting insulin doses you've taken on time, over the last 7 days Long-acting on schedule How many long-acting insulin doses you've taken on time, over the last 7 days

32 32 Glucose today Your glucose entries for today Morning glucose Your first glucose reading of the day, for the last 4 days

33 33 Recent meals & glucose after Three recent meals and the glucose reading after each meal Carbs each day The carbs you entered each day, for the last 10 days

34 34 Adding a Device You may connect two Gocap pen caps to the Gocap App. To connect an additional Gocap, follow these steps: 1 Tap Devices on the top navigation menu. 2 Scroll down and tap the Add a device button at the bottom of the screen. 3 Tap the Gocap button. 4 Plug one end of the micro USB cable into the port on the tip of your Gocap, plug the other end into the AC power adapter, and then plug the power adapter into a wall outlet.

35 5 Tap the Ready button on the Connect your Gocap screen. 35 The Connecting screen displays. The Gocap App automatically tries to establish a connection with the Gocap. If the Gocap App fails to establish a connection, an Oops! screen displays. To try again, tap the Try again button. For more information about difficulties connecting, see Troubleshooting Connection Problems (Page 22). If you want to use an Apidra pen with Gocap, you must switch Gocap from long-acting insulin mode to fast-acting insulin mode. See Changing Modes on the Gocap (Page 24) for more about inserting and removing insulin pens.

36 36 Sharing your information with others You can share the information stored in your Gocap App with others using the Sharing function. These people are called your followers. Followers can be anyone you choose a friend, a family member, a care provider, or your doctor. Follow these steps to share your information. 1 Tap Sharing on the top navigation menu. Note: You must be connected to the Internet to edit your sharing settings. If you are not connected to the Internet, a screen that instructs you to connect appears. 2 Tap the Invite a follower button near the bottom of the screen.

37 3 Enter a working address in the appropriate field on the screen for the person you want to invite to follow you Tap the Send invitation button. The Gocap App sends an invitation to the address you entered. 5 Tap the Done button near the top of the screen. The follower appears on the Sharing screen. Note: Once you have added a follower, it is easy to remove them. Just tap the Remove followers button in the Sharing screen, then tap Delete next to the row for the follower you wish to remove.

38 38 Setting up Gocap Alerts Your Gocap and the Gocap App can provide alerts and notifications to you. Some of these appear in the Gocap App on your smartphone, and some come directly from the Gocap. Some alerts and notifications are based on a dosing schedule you set up in the Gocap App. Instructions for setting up a dosing schedule are in this section. If you do not set up a dosing schedule, the alerts or notifications like Did you take your insulin? or Fast-acting at wrong time? will not be triggered. Here are the alerts or notifications you may see or hear: Alert type Triggered when... What you see/hear Did you take your insulin? No dose is recorded within an hour of the time set using the dosing schedule you have set up. Message in your smartphone's notification center; Message when you open the Gocap app.

39 Alert type Triggered when... What you see/hear 39 Fast-acting at wrong time? (Android only) You take out a fast-acting pen during a longacting scheduled dose time. Gocap beeps rapidly 15 times when insulin pen is removed from the Gocap; A red band with message displays in the Logbook. Unusually high dose (Android only) The last dose was much higher than other doses in the Gocap logbook. Red band with message displays in the Logbook. Double dose or split dose? (Android only) Two doses were logged very close together. Red band with message displays in the Logbook.

40 40 Alert type Triggered when... What you see/hear Insulin was too hot. Gocap isn't connected. The temperature of your insulin pen was higher than the manufacturer's recommended range. Gocap hasn't been able to sync for more than a day. Red band with message appears in the Logbook, and/or the Gocap displays HOT on its screen. A red band with message appears in the Logbook. Insulin expired. (Android only) Insulin pen could be past the manufacturer s use-by date. A red band with message appears in the Logbook. Time to check your glucose! (Android only) or Time to log your long-acting! You set a glucose or dose reminder for yourself. A message appears in the mobile device's notification center, reminding you to log an entry.

41 To turn any of these alerts to Off, navigate to the Settings screen, then tap on Alerts. 41 A screen displays the alerts. Tap the button to the right of the option button to toggle the alert to Off.

42 42 Setting Up a Dosing Schedule Follow these steps to set up or change your dosing schedule. 1 Tap Settings on the top navigation menu. The Settings screen displays. 2 Tap the Dosing schedule button. The Dosing Schedule screen displays. The screen has a section for long-acting insulin and a section for fast-acting insulin. 3 Create an entry for each of your scheduled doses. To create an entry, tap the button to the left of the appropriate dose. A time selector screen displays.

43 4 Enter the time of day you usually take the dose Tap the Done button to save your dosing schedule information. Note: Taking a dose within an two hours of your scheduled time will meet your schedule. If you miss a scheduled dose, you will see a "Did you take your insulin?" message in the Gocap App.

44 44 Recharging Your Gocap Your Gocap uses a rechargeable battery. Battery life depends on environmental and use factors. Depending on use, your Gocap will operate for approximately 1 week before it needs to be recharged. For best results, charge your Gocap as often as you can. To recharge the battery, attach the micro USB cable to the Gocap and then plug the other end of the cable into either the Gocap AC adapter which you then plug into a wall outlet, or a computer USB port. Recharging the battery can take up to 3 hours. Note: When your Gocap s rechargeable battery can no longer hold a charge, it cannot be replaced. You will need to replace your Gocap. Visit support at help@gocap.me, or call to learn more.

45 Recharge your Gocap when you see the empty battery icon. 45 The empty battery icon means the battery does not have enough power for the Gocap to operate correctly. You must recharge the Gocap immediately before using it again. If you use the Gocap App, you can also check the battery status on the Devices screen.

46 46 How to Recharge your Gocap Follow these directions to recharge your battery, using the method you prefer. Note: You can use your Gocap while it is charging if the Charge Indicator Light is glowing. If the battery is very low, you may have to wait for the charging light to come on. CAUTIONS If the micro USB cable, USB AC adapter, or Gocap is damaged, discolored, abnormally hot, or has an unusual odor, do not recharge the battery. Contact Gocap support by visiting ing or calling Charge the battery only in a dry area indoors.

47 Recharging the Gocap 47 1 Plug one end of the micro USB cable into the port on the tip of your Gocap, plug the other end into the AC power adapter, and then plug the power adapter into a wall outlet. You can also plug your USB cable directly into a laptop or desktop computer, but make sure the computer is not in sleep mode. The Charge Indicator Light glows red on the Gocap.

48 48 If you do not see a glowing light, try another USB port, another USB cable, or another wall outlet. 2 When the battery is fully charged, the Charge Indicator Light turns green. Note: If the Charge Indicator Light has not turned green after 3 hours of recharging, check to see that the micro USB cable is correctly plugged into the USB port or into the adapter. If this does not solve the problem, contact Gocap support at help@gocap.me, or call Note: If you use a wall outlet, make sure the voltage on the wall outlet matches the voltage on the AC adapter. Depending on the country you are in, you may need an additional adapter before you can plug the AC adapter into a wall outlet.

49 Caring For Your Gocap 49 Storing Your Gocap After you have placed the Gocap on an insulin pen, store the pen with the Gocap as recommended by the insulin pen manufacturer. Overview of Cleaning Clean your Gocap regularly. Cleaning your Gocap helps assure that it functions normally. Cleaning Your Gocap To clean your Gocap you need the following items, available from most drug stores and grocery stores: Isopropyl alcohol wipes Clean gauze Isopropyl alcohol antiseptic spray (in a spray bottle) 6-inch Q-Tip cotton swabs (longer than normal 3-inch swabs) Follow the safety instructions included with these items. Follow these steps to clean your Gocap:

50 50 1 Clean the outside of the Gocap. Hold the Gocap with the USB port pointing down. Wipe the outside of the Gocap with an isopropyl alcohol wipe. Be sure to squeeze out any excess liquid before you wipe the dosing monitor. Wipe the Gocap dry with clean gauze. 2 Clean the inside of the Gocap. Spray the inside of your Gocap with isopropyl alcohol. Pour out any remaining solution. Use a Q-Tip cotton swab to wipe and dry the surface of the inside of the Gocap. Make sure the inside of the Gocap is dry and free of residue before using.

51 Troubleshooting Gocap Problems 51 Handling Gocap Problems Here are some possible problems you may experience with your Gocap and steps you can take to resolve each. Problem Gocap will not turn on Gocap will not recharge when plugged into a USB power source. Gocap will not recharge after you have tried recharging it with two different USB power sources. What to do Recharge the battery. Plug into the provided micro USB cord and AC power adapter for at least 3 hours. Plug into a different power source for at least 3 hours. Contact Gocap support at help@gocap.me, visit or call

52 52 Problem Gocap's display screen shows "HOT". What to do "HOT" indicates that the temperature is too high for your Gocap to work properly. You should keep your Gocap safe from very hot places. Gocap s display screen shows only dashes. No reading or dose information is shown. The dashes indicate a problem with the Gocap s ability to read the insulin pen. Review the possible causes on page 58 and take steps to correct the problem. If those steps do not resolve the problem, contact Gocap support at help@gocap.me, or visit help.

53 Here are some possible causes of the screen display of dashes that indicates an error condition, and what you should do about each. 53 Possible cause Gocap is dirty. The insulin pen is dirty. Gocap is damaged. Gocap is broken. The insulin pen is damaged. What to do Clean your Gocap. Clean the insulin pen. Contact Gocap support at or visit Discard the Gocap and replace it with a new Gocap. Discard the damaged pen and replace with a new pen.

54 54 Possible cause What to do Gocap is outside its temperature operating range (too hot or too cold). Move to a warmer or cooler location as needed to bring Gocap within its temperature operating range. The insulin pen is not properly placed inside Gocap. See Using the Gocap (page 14) to review the steps for using an insulin pen with Gocap. Remember to push the insulin pen into the Gocap and turn it until you feel the pen click. Something other than an insulin pen is inside Gocap. Remove the object, and place an insulin pen inside Gocap.

55 Handling Unread Doses 55 Occasionally, Gocap may show an "unread dose" entry in your logbook. An unread dose can occur during normal use of Gocap, but also may indicate a problem with Gocap or its use. Here are some possible causes of an unread dose entry, and what you should do about each. Possible cause What to do You removed and replaced Gocap from and to an insulin pen without dosing. Tap the unread dose entry in the logbook. If you did not take a dose, delete the entry. There is a problem with the Gocap or its use. See Handling Gocap Problems (page 56).

56 56 Handling Other Problems If you are experiencing a health problem or medical emergency, you should contact your healthcare provider or emergency services. Travelling with Your Gocap When travelling with your Gocap, remember: Bring the provided charging cord and USB adapter so you can recharge your Gocap. Countries can have different types of power outlets. You should find out whether you need to bring a power adapter for your charging cord. Time zones can change. If you travel to a new time zone, you should double-check to make sure your dosing schedule is correct. Disposing of Your Gocap Electrical products waste should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.

57 Gocap System Technical Specifications 57 Model Dimensions Measurement Method Measurement Range Power Supply Battery Charging Wireless Storage Conditions Operating Conditions Life Span mm 25mm 26mm, 30g Optical units DC 3.7V Nominal 45mAh Lithium Polymer Battery DC A USB Charger Bluetooth v4.0 Dual Mode 2.4GHz 20 C 45 C 1 C 45 C, 10-90% relative humidity 1 year

58 58 If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. FCC Notice This device 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. About Common Sensing Gocap dose monitor by: Common Sensing, Inc Cambridge, MA common-sensing.com

59 Warranty Information 59 Common Sensing, Inc. (the "Company") hereby warrants that its product with which this One Year Limited Warranty (this "Warranty") is included (the "Product") will operate as intended and free of material defects for a period of one (1) year from its date of original sale. THE SOLE REMEDY UNDER THIS WARRANTY SHALL BE A REFUND OF THE PRODUCT'S PURCHASE PRICE, OR REPAIR OR REPLACEMENT OF THE PRODUCT, IN ANY EVENT AT COMPANY'S SOLE AND ABSOLUTE DISCRETION. THIS WARRANTY SHALL BE MADE VOID AND OF NO FURTHER FORCE OR EFFECT IN THE EVENT OF ANY OF THE FOLLOWING: A TAMPERING WITH OR DISASSEMBLY OF THE PRODUCT; B FAILURE TO OPERATE OR CARE FOR THE PRODUCT IN A REASONABLE MANNER OR AS SPECIFIED IN ANY COMPANY INSTRUCTIONAL OR TECHNICAL LITERATURE (THE "MANUALS"); C ANY USE OF THE PRODUCT OTHER THAN AS SET FORTH IN THE MANUALS AND D ANY RELIANCE ON THE PRODUCT FOR TREATMENT

60 60 DECISIONS, INCLUDING WITHOUT LIMITATION ANY INSULIN OR GLUCOSE DOSING DECISIONS. THE COMPANY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

61 CS1142 Rev