COMPANION InPen Instructions For Use Manual
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COMPANION InPen Instructions For Use Manual

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Instructions for Use
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Summary of Contents for COMPANION InPen

  • Page 1 InPen System ™ Instructions for Use...
  • Page 2 Prime your InPen™ (Before Every Injection) ..41 Selecting Your Dose ..........44 14. Injecting the Dose ............46 15. How Much Insulin is Left in Your InPen™? ...49 Replacing a Used Insulin Cartridge .....50 Handling and Storage of Your InPen™ ....50 18. Cleaning of Your InPen™ .........51 Disposal ..............
  • Page 3 Symbols in This User Guide The following symbols are found on the InPen™ or the package labels. These symbols tell you about the proper and safe use of the InPen™ System. Non-ionizing Radiation Consult Instructions For Use Caution Do Not use if Package is Damaged...
  • Page 4 1. Introduction This user guide will explain how to use your InPen™ and the InPen™ Application (app). Read it carefully before you use your InPen™. You should read this manual before use – even if you have used the InPen™ before. Failure to follow the instructions may result in too much or too little insulin being delivered.
  • Page 5 System Description The InPen™ system includes the InPen™ smart insulin pen and the InPen™ App. The InPen™ system automatically records dose size and timing of insulin doses, provides reminders if insulin is not taken, includes an insulin dose calculator with personalized...
  • Page 6 3. Contraindications: The InPen™ system is not intended for anyone unable or unwilling to: • Test blood glucose (BG) levels as recommended by a healthcare provider •...
  • Page 7 The InPen™ App is not recommended on Jailbroken or Rooted devices. Your smart device must have enough memory storage or the InPen™ App will not be able to be installed or log dose. You may need to delete files or apps from your smart device.
  • Page 8 Your healthcare provider may have already entered these for you at your visit. If not, you can find these on your InPen Prescription Form. If you do not have your Therapy Settings you can skip this section of the wizard and complete it later. The dose calculator will be locked out until these settings are entered.
  • Page 9 There are three different ways to calculate insulin doses using the InPen™ App. Your healthcare provider has prescribed you one of the following: • Fixed Dosing • Meal Estimation • Carbohydrate Counting Once you have your dose calculator settings, tap on each line to set the correct value.
  • Page 10 1. Fixed Dose Mode - Setup The following settings must be set before you can begin fixed dosing: Maximum Calculated Dose – The maximum calculated dose that your healthcare provider determines is safe for you. If a single dose recommendation or the total of recent doses plus the recommendation exceeds the maximum calculated dose setting, an alert will be displayed.
  • Page 11 How to Use • In Fixed Dose mode the Dose Calculator will provide a fixed dose insulin recommendation at meal times. • After choosing your meal, you can enter a current glucose for a dose recommendation that includes a glucose correction if needed. •...
  • Page 12 Each day at meal times, the InPen™ App will ask you what size meal you are eating and recommend the correct dose. Tap the meal size to adjust it.
  • Page 13 3. Carb Counting Mode - Setup The following settings must be set before you can begin carb counting dosing: Maximum Calculated Dose – The maximum calculated dose that your healthcare provider determines is safe for you. If a single dose recommendation or the total of recent doses plus the recommendation exceeds the maximum calculated dose setting, an alert will be displayed.
  • Page 14 How to Use • In Carb Counting mode the Dose Calculator will provide a carbohydrate counting insulin recommendation once you have entered a current glucose or carbohydrates (Carbs) only, or both. • Enter your current glucose and/or the number of grams of Carbs you are eating or plan to eat and tap Save.
  • Page 15 5.5 Connect InPen IMPORTANT: To ensure a secure connection, pair your InPen™ and smart device in a secure area with limited Bluetooth® devices in range. CAUTION: Make sure you know which InPen™ you are pairing with your smart device.
  • Page 16 Follow the instructions in the app to pair your InPen™. The InPen™ App will display Pairing Successful once InPen™ and your smart device are paired. Follow the instructions to name your InPen™. Read the important notes regarding treatment decisions.
  • Page 17 The smart device checks and updates the date and time in your InPen™. Check the date and time on your device often to be sure it is correct. Check the date and...
  • Page 18 For instructions on setting the date and time on your device, see the user manual for your device. The InPen™ App is known to be free of malware. 6. Using the InPen App Calculator/...
  • Page 19 Insulin Usage The Home screen shows an overview of your recent glucose and insulin use. Current Glucose shows the last glucose you entered or measured with a connected BGM or supported CGM. If the glucose is more than 10 minutes old, the value will show “---”...
  • Page 20 WARNING: If your InPen™ is out of range of the smart device the Dose Calculator may not have all of your recent insulin logged and may result...
  • Page 21 You may give the dose using your InPen™ and it will be automatically logged. NOTE: Only prime your InPen™ after you have calculated your dose. Grams of Carbs – Based on your current Active Insulin,...
  • Page 22 6.3 Split Doses The InPen™ can deliver a maximum of 30 units per injection. For doses greater than 30 units the dose must be split into multiple doses. If for any reason a dose is split into multiple doses, each dose that is delivered will be logged separately.
  • Page 23 If you forget how much insulin was in the cartridge, you can use the dose calculator again to determine the remaining dose required. Your InPen™ will automatically determine whether a dose was therapeutic (injected into your skin) or prime...
  • Page 24 Active Insulin and used by the Dose Calculator. InPen™ automatically determines if a dose was a Prime or a Therapeutic dose. If you need to adjust whether a dose was a Therapeutic dose or a Prime, tap the entry in the Logbook.
  • Page 25 When enabled, it will alert you 2 hours after a Rapid- acting insulin dose is taken with the InPen or manually logged. To enable or disable the reminder, slide the switch.
  • Page 26 7.2 Insights by InPen Reports ™ IMPORTANT: The Insights by InPen™ report is intended to supplement, not replace, medical expertise in the self-administration of insulin for the treatment of diabetes. The report provides information that can be used to identify trends to inform treatment decisions.
  • Page 27 Glucose – The average glucose value entered into the dose calculator or imported from a connected BGM or CGM. Use this chart to understand: • Average and standard deviation of your glucose over the report period • Percentage of time spent in and out of the target glucose range Dose Calculator Usage –...
  • Page 28 Long-acting doses not logged within three hours before or after the long acting reminder time are considered missed doses. Missed long acting doses are calculated only when the long acting reminder is enabled. The average number of doses taken per day is also shown.
  • Page 29 Insulin Settings – Insulin settings configured within the app will display beneath the Modal Day Glucose chart. The settings are aligned to the time of day they are programmed within the app. Long-acting Assessment: The fasting window is determined based on the time with the fewest Rapid- acting doses or you can specify your own.
  • Page 30 Note: Glucose values taken on the same day, are the same color and are connected with lines. The lines are for reference only when viewing BGM data. Actual blood glucose between glucose points is unknown. Meal Assessment: Each meal window (Breakfast, Lunch, and Dinner) is based on the Meal Time window set within the App.
  • Page 31 Daily Charts – Graphical representations of individual daily glucose, insulin doses, and carbohydrates/meal type. Glucose from CGM or BGM is shown in purple with carbohydrates/meal shown in green. Rapid-acting insulin doses are shown as blue filled curves and Long- acting insulin doses are shown as blue circles. Use the daily charts to visualize and assess patterns in glucose, insulin, and carbohydrates on a daily basis for the last 7 or 14 days of the report period.
  • Page 32 7.3 Dose Calculator Algorithm To help you better manage and understand your therapy, the dose calculator algorithm is as follows: The fixed-dose calculator algorithm is as follows: Where: DR = Dose Recommendation CE = Carbohydrates Entered ICR = Insulin to Carbohydrate Ratio BG = Blood Glucose TG = Target Blood Glucose ISF = Insulin Sensitivity Factor...
  • Page 33 Low Battery – This icon will appear when the InPen™ is reaching the end of its 1-year life and needs to be replaced. It will appear several times near the end of the lifetime and will remain visible until a new InPen™...
  • Page 34 The dose calculator only accepts values between 0 - 300g. If you believe the message is in error, then check the value you entered. To use the dose calculator, you must have an InPen™ paired to your device. See the Getting Started section for pairing instructions.
  • Page 35 To use the dose calculator, you must enter your personal settings into Therapy Settings. If you do not have your therapy settings from your healthcare provider, then you need to obtain them before proceeding. It is critical for safety that therapy settings are set correctly.
  • Page 36 8.3 Common Problems and Solutions The table below lists some potential issues that may arise during use of the InPen™ system and solutions to try. Problem Solutions to Try I can’t install the Check that your smart device is app.
  • Page 37 I left my InPen™ You may take Rapid-acting insulin somewhere and from sources other than your I need to take InPen™ if needed. When you do, insulin from be sure to manually log the dose into the InPen™ App. See Manually another source.
  • Page 38 The Missed Dose Reminder will only remind you if you have not taken a dose. If you use your InPen normally and take doses at your regular times each day, then the reminder will not appear.
  • Page 39 9. Compatible Insulin and Needles InPen™ is compatible with 3 mL (U-100) insulin cartridges and disposable needles (supplied separately). Refer to the table below to determine compatible insulin and needles for use with your InPen™: Always check the insulin label before each injection to avoid medication errors.
  • Page 40 Your healthcare provider has prescribed the type of insulin best for you. Any changes in insulin should be made only under medical supervision. • InPen is for use only with 3 mL U-100 Insulin Cartridges. • Only use Insulin Cartridges compatible with your InPen™.
  • Page 41 InPen™. Then carefully line up the Cartridge Holder with the InPen Body and screw together until secure. 2. Why do I pull the InPen™ apart when I try to remove the InPen™ cap? Twisting the InPen™ Cap may have unscrewed the Cartridge Holder.
  • Page 42 Turn the Dose Knob to select amount to prime: • Dial 2 units as shown. Hold the InPen™ so the needle is pointing up and tap the cartridge to collect any air at the top. Prime the InPen™ by pushing the Injection Button with your thumb and holding for eight (8) seconds.
  • Page 43 1. Why is it important to prime before every injection? If you do NOT prime, you may get too much or too little insulin. Priming helps to ensure that the InPen™ and needle are working properly. Once the InPen™ is properly primed, insulin will flow from the needle.
  • Page 44 4. What should I do if I have an air bubble in the Cartridge? Priming your InPen™ will remove air. Hold the InPen™ so that the needle is pointing up, and tap the Cartridge gently with your finger so any air bubbles can collect near the top.
  • Page 45 Selecting Your Dose 1. How do I read the dose indicator? The InPen™ can be adjusted in steps (increments) of 0.5 (½) units. Read the numbers shown in the indicator window to see the current dose setting. If the indicator is between numbers, this means that it is set at a ½...
  • Page 46 14. Injecting the Dose 1. Choose a place on your body to inject. Make sure your skin is clean and dry. Places to Inject: Upper Arms Stomach Thighs 2. Insert the needle into your skin as your healthcare provider has instructed you. 3.
  • Page 47 Note: To prevent air from entering the Cartridge, do not store the InPen™ with a needle attached. 6. Place the cap back onto the needle, and remove the capped needle by twisting it off.
  • Page 48 Frequently Asked Questions about Injecting the Dose 1. Why does the InPen not deliver any insulin when I turn the dose button to inject? Turning the dose button will not deliver insulin. You have to press the dose button to inject.
  • Page 49 Your Injection Button may become harder to push if the inside of your InPen™ gets dirty with insulin, food, drink, or other materials. Following the HANDLING AND STORAGE instructions below should prevent this 3. Why doesn’t the Dose Knob go to zero when I inject...
  • Page 50 17. Handling and Storage of Your InPen ™ When an Insulin Cartridge is installed in your InPen™, store your InPen™ at room temperature. Refer to your insulin manufacturer or literature that came with your insulin for information on how to store the cartridges and how long to keep them.
  • Page 51 Frequently asked Questions about Caring for your InPen ™ 1. What should I do if my InPen™ has been dropped or knocked against a hard surface, or if I am not sure that it is working properly? If you suspect that your InPen™ has been damaged...
  • Page 52 Android is a registered trademark owned by Alphabet Inc. About Bluetooth® Bluetooth is a type of wireless (RF) communication. Cell phones use Bluetooth technology as do many other devices. Your InPen™ uses Bluetooth to pair with your smart device and to send data to the InPen™ App.
  • Page 53 Your InPen™ is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules for devices with RF capability. These rules state two conditions specific to the operation of the device. They are: • This device may not cause harmful interference.
  • Page 54 ISO 11608-1. Applied Parts The InPen™ is a hand held device and is considered the applied part as defined by IEC 60601-1. Declaration of Conformity Companion Medical declares that this product is in...
  • Page 55 All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. Use of the InPen™ system is subject at all times to the Companion Medical Inc. Terms of Service (https:// www.companionmedical.com/terms-of-service) and Privacy Policy (https://www.companionmedical.com/...
  • Page 56 Product Specifications The InPen™ System is intended for use by patients at home and in healthcare facilities. Operating Conditions 5 °C (41 °F) to 40 °C (104 °F) 15 % to 93 % RH (non condensing) Operating Altitude -381 m (-1253 ft) to 3010 m (9878 ft) Operating Pressure 80 kPa –...
  • Page 57 For information contact: 1282 Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego, CA 92128 USA www.companionmedical.com Cormedics Medizintechnik GmbH Bahnhofstrasse 32 82041 Deisenhofen Germany ©2020 Companion Medical, Inc. LBL-00706-AF 10-2020...

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