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COMPANION InPen, Instructions For Use Manual

COMPANION InPen is a cutting-edge smart insulin pen designed to help users manage their diabetes effectively. For detailed guidance on how to use this revolutionary device, refer to the Instructions For Use Manual. Download the manual for free from our website for step-by-step instructions on how to optimize your diabetes care.

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For information contact:

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

1282

Summary of Contents for InPen

Page 1: ...1 InPen System Instructions for Use...

Page 2: ...lin and Needles 39 10 Getting Ready 39 11 Prepare your InPen 39 12 Prime your InPen Before Every Injection 41 13 Selecting Your Dose 44 14 Injecting the Dose 46 15 How Much Insulin is Left in Your InP...

Page 3: ...ult Instructions For Use Caution Do Not use if Package is Damaged Temperature Limitation Humidity Limitation Pressure Limitation Keep Dry Protection Against Insertion of Large Objects and Dripping Wat...

Page 4: ...ce of a sighted individual trained to use it Always carry a spare insulin delivery device in case your InPen is lost or damaged The InPen App is a diabetes management tool that helps track your insuli...

Page 5: ...therapy reports with your healthcare provider Support Setup wizard within the app User Guide links within the app Instructional videos within the app 2 Indications for Use The InPen is a home use reus...

Page 6: ...the InPen System to sale by or on the order of a physician Important Pediatric User Information The following recommendations are meant to help younger patients and their caregivers manage and care f...

Page 7: ...lar data is enabled whenever possible Caution You must first pair your InPen with a smart device and the InPen App This will ensure that doses from your InPen are sent wirelessly to the App on your sm...

Page 8: ...vider 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 an...

Page 9: ...e the Meal Therapy mode 1 Go to Therapy Settings then proceed after reading the disclaimer 2 Tap Meal Therapy and select the new Meal Therapy mode prescribed by your healthcare provider 3 Tap on each...

Page 10: ...the Dose Calculator it will recommend insulin or carbohydrates to return to this target value Insulin Sensitivity Factor This is the amount your blood glucose is lowered by 1 unit of insulin Time of D...

Page 11: ...settings must be set before you can begin meal estimation dosing Maximum Calculated Dose The maximum calculated dose that your healthcare provider determines is safe for you If a single dose recommen...

Page 12: ...ctive until the next column s time is reached Tap the time to adjust it Note that the times must be in order and cannot overlap Time of Day settings are disabled by default See Advanced App Features f...

Page 13: ...throughout the day By sliding the switch to the right you can set these parameters to four different values throughout the day To disable this feature slide the switch back to the left Time of Day If...

Page 14: ...se for more about the types of recommendations you may receive When you have entered all values and carefully checked that they are correct tap Next 4 Long acting Insulin The app will remind you to ta...

Page 15: ...end which may be different 5 4 Bedtime The setup wizard will next ask you when you typically go to bed Consider the time before bed when you would be able to check your glucose and take any correction...

Page 16: ...for more detailed instructions 5 6 Taking an Insulin Dose Follow the video instructions in the app for an overview of how to take an insulin dose See Section 12 Prime your InPen Before Every Injectio...

Page 17: ...Do Not Disturb feature on your smart device if available Start the app after your smart device is restarted Set the volume on your smart device at a level you can hear Do not kill or force close the a...

Page 18: ...InPen Battery Rapid acting Reminder Long acting Reminder Alert Trend Graph Notification icons time on your device when you travel across time zones Keep set Automatically enabled and let your smart de...

Page 19: ...being used in the body It is based on the recent doses you ve taken and your Therapy Settings If you take a 5 U dose there will initially be a full 5 units in your body Over several hours this will d...

Page 20: ...ator Do not use the Dose Calculator if you have guessed settings or believe they may be set incorrectly IMPORTANT All insulin you have recently taken must be entered to ensure that Active Insulin is c...

Page 21: ...ut saving the entry Once you have entered current glucose and or carbohydrates meal information you may see one of the following recommendations Units of Insulin Based on your current Active Insulin a...

Page 22: ...of the screen to see the math used in the calculation Tap the back arrow to return and save your dose Note that dose recommendations are rounded down to the nearest half unit IMPORTANT The calculated...

Page 23: ...Rapid acting insulin dose Long acting insulin dose and cartridge replacement is listed with the time it occurred All doses taken from your InPen will be listed here along with any doses of Rapid actin...

Page 24: ...book The Dose Calculator does not account for manual injections that you do not enter and could recommend more insulin than needed Too much insulin may cause hypoglycemia IMPORTANT Your mobile device...

Page 25: ...the correct dose tap Save to save it and return to the Home screen To exit without saving a dose tap Cancel 7 Advanced App Features 7 1 Reminders The Check BG 2hrs After Dose Reminder helps you rememb...

Page 26: ...tab The report covers through the end of the previous day so the current day s activity will not be included To send this report to yourself or a health care provider tap the share icon Then select ei...

Page 27: ...dose calculator was used within 10 min prior to the dose Percentage of doses taken within 0 5 U of the advised dose Percentage of doses taken 1 U over or under the advised dose Missed Doses The averag...

Page 28: ...ose The chart shows median values in black quartile ranges in dark bands and 10 90 values in lighter bands A fixed target range of 70 180 mg dL is shaded grey with the glucose data overlaying This can...

Page 29: ...the 2 hours prior to the start of the fasting window are excluded This assessment may help identify The median bedtime glucose value at least 2 hours after last meal of the day The median fasting gluc...

Page 30: ...ged Doses delivered outside of the set Meal Time window are not included in the meal assessment This assessment may help identify The median glucose at the start of each meal The median glucose at the...

Page 31: ...in and carbohydrates on a daily basis for the last 7 or 14 days of the report period On each bolus indicates the dose was within 0 5U of the recommendation indicates the dose was 1 U or more higher th...

Page 32: ...AI Active Insulin1 Meal Dose Specified Meal Dose If glucose is not entered Active Insulin is not included in the calculation and only a carbohydrate dose is calculated per the following Where DR Dose...

Page 33: ...visible until a new InPen is paired Temperature This icon will appear when the InPen detects a very high or very low temperature Based on the temperature of the InPen you may want to consider replacin...

Page 34: ...lue you entered The dose calculator only accepts values between 20 600 mg dl If you believe the message is in error then check the value you entered If your blood glucose is outside this range take im...

Page 35: ...afety that therapy settings are set correctly See the Getting Started section for Therapy Settings setup instructions This important safety warning is shown every time you access Therapy Settings Tap...

Page 36: ...ns Problem Solutions to Try I can t install the app I paired my InPen but doses are not appearing on the app Check that Bluetooth is enabled on your smart device Move the InPen and your smart device w...

Page 37: ...en you do be sure to manually log the dose into the InPen App See Manually Log Rapid acting Insulin for instructions on how to manually log a dose For safety it is important to log all Rapid acting in...

Page 38: ...hen the reminder will not appear You can adjust the start and end times of the Missed Dose Reminder to fit your personal routine in Settings Therapy Settings Problem Solutions to Try I m trying to adj...

Page 39: ...re you have the following items available before beginning InPen 3 mL U 100 Insulin Cartridge New Pen Needle 11 Prepare your InPen 1 Pull Off Cap 2 Unscrew and Remove the Cartridge Holder InPen Model...

Page 40: ...secure CAUTION If the Cartridge Holder is not securely attached the cartridge may be misaligned and you may not get your full dose Important Notes Your healthcare provider has prescribed the type of i...

Page 41: ...screwed all the way back inside the 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...

Page 42: ...pointing up and tap the cartridge to collect any air at the top 6 Prime the InPen by pushing the Injection Button with your thumb and holding for eight 8 seconds You should see a few drops of insulin...

Page 43: ...needle You may need to prime several times before you see insulin 2 Why can it take several attempts to prime when a new Cartridge is inserted There may be a gap between the Screw and the Cartridge P...

Page 44: ...Pen so that the needle is pointing up and tap the Cartridge gently with your finger so any air bubbles can collect near the top Repeat the priming steps until insulin is seen A small air bubble may re...

Page 45: ...dose indicator The InPen can be adjusted in steps increments of 0 5 units Read the numbers shown in the indicator window to see the current dose setting If the indicator is between numbers this means...

Page 46: ...structed you 3 To inject your insulin place your thumb on the Injection Button then slowly and firmly push the button until it stops moving 4 Continue to hold the button for 8 seconds and then remove...

Page 47: ...delivered dose 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 7 Put...

Page 48: ...ently 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...

Page 49: ...ceive Remember this number because you still need to inject this much to complete your dose Adjust the knob back to the 0 setting Remove the Needle from the InPen If the cartridge is empty replace it...

Page 50: ...Hold the InPen knob and turn the Screw counterclockwise into the InPen Body until it stops 3 Follow the instructions in PREPARING YOUR INSULIN INPEN section above Dispose of the used cartridge before...

Page 51: ...your InPen as this may damage it Keep it away from direct sunlight water dust and dirt Do not expose your InPen without cartridge to temperatures below 5 C 23 F Do not try to repair a broken InPen Wh...

Page 52: ...e but do so in a safe and environmentally correct way Remove the needle and cartridge and throw them away as your doctor or nurse has instructed you Throw your InPen away as specified by your local au...

Page 53: ...rning off these electronic devices may allow communication The InPen has been tested and found to be appropriate for use at home In most cases it should not interfere with other home electronic device...

Page 54: ...ent and Council Directive 93 42 EEC of 14 June 1993 concerning medical devices M5 FCC Compliance This device complies with FCC Part 15 license exempt RSS standard s Operation is subject to the followi...

Page 55: ...e or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate The remedies provided for in this war...

Page 56: ...erating Pressure 80 kPa 105 kPa Storage Conditions 5 C 23 F to 40 C 104 F 10 to 98 RH non condensing Dimensions 16 5 cm 6 5 x 1 9 cm 0 8 Weight 35 g Power Supply Li Mn battery not replaceable Lifetime...

Page 57: ...mpanion 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 I...

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