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COMPANION InPen User Manual

Reusable pen injector
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User Guide
InPen™ Reusable Pen Injector

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Summary of Contents for COMPANION InPen

  • Page 1 User Guide InPen™ Reusable Pen Injector...

  • Page 2: Symbols In This User Guide

    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...

  • Page 3: Table Of Contents

    Your InPen? ........26 Replacing a Used Insulin Cartridge ..........27 Handling and Storage of Your InPen ......... 27 Cleaning of Your InPen ..28 Replacement ......30 Disposal ......... 30 Supplemental Information31 Warranty ....... 32 Product Specifications ..34...
  • Page 4 Page 4 of 34...

  • Page 5: Introduction

    DO NOT SHARE YOUR INPEN OR NEEDLES AS INFECTION OR DISEASE CAN BE SPREAD FROM ONE PERSON TO ANOTHER. If any of the parts of your InPen appear broken or damaged, DO NOT USE. Contact your healthcare provider for a replacement.
  • Page 6 InPen is lost or damaged. InPen connects to an optional mobile device application - the InPen App - via Bluetooth®. The InPen transmits dose information so that the application (“app”) can help you remember the...
  • Page 7 Page 7 of 34...

  • Page 8: Indications For Use

    Adapted from Mudaliar et al, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501. Indications For Use The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin.

  • Page 9: Contraindications

    • Maintain sufficient diabetes self- care skills, or • Visit a healthcare provider regularly. Caution: US law restricts the sale of the InPen System to sale by or on the order of a physician. Page 9 of 34...

  • Page 10: Compatible Insulin And Needles

    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: InPen Compatible Compatible Model U-100 3 mL...
  • Page 11 4. Insert the small end of the Insulin Cartridge into the Cartridge Holder. 5. Attach the Cartridge Holder by pushing the Cartridge Holder and InPen Body straight together. Screw the InPen Body onto the Cartridge Holder until it clicks and is secure. Page 11 of 34...
  • Page 12 • 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 13: Prime Your Inpen (Before Every Injection)

    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 14 Caution: If you do NOT prime, you may receive too much or too little insulin. 1. Remove Paper Tab from the Needle 2. Attach the Needle by screwing the Needle straight onto the Cartridge Holder as shown. 3. Pull off the Outer Cap and the Inner Cap.
  • Page 15 5. Hold the InPen so the needle is pointing up and tap 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 16 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. You may need to prime several times before you see insulin.
  • Page 17 Repeat the priming steps until a stream of insulin is seen. If you are still unable to see a stream of insulin out of the Needle, do NOT use the InPen. Contact your healthcare provider for assistance or to obtain a replacement.

  • Page 18: Selecting Your Dose

    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 19 Frequently Asked Questions about 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.

  • Page 20: Injecting The Dose

    Set to 0 units. The indicator line is aligned with the “0” mark, which means nothing will happen if the button is pressed. Store the InPen this way. Set to ½ unit. This is the smallest dose setting possible. Set to 1 unit. The...
  • Page 21 Places to Inject: Upper arms Stomach Thighs 3. Insert the needle into your skin as your healthcare provider has instructed you. 4. To inject your insulin, place your thumb on the Injection Button, then slowly and firmly push the button until it stops moving. 8 Seconds! Page 21 of 34...
  • Page 22 Note: To prevent air from entering the Cartridge, do not store the InPen with a Needle attached. 7. Place the cap back onto the Needle, and remove the capped Needle by twisting it off.
  • Page 23 FDA website at: www.fda.gov/safesharpsdisposal 10. Replace the cap on your InPen. Important Notes You must PUSH the Injection • Button straight down for the dose to be delivered.
  • Page 24 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 25 Injection Button during injection. Ask your healthcare provider which Needle is best for you. If none of the above steps resolves the problem, your InPen may need to be replaced. Your Injection Button may become harder to push if the inside of your InPen gets dirty with insulin, food, drink or other materials.

  • Page 26: How Much Insulin Is Left In Your Inpen

    EMPTY CARTRIDGE It is ok to set a dose greater than the amount of remaining insulin. The InPen will deliver as much insulin as is left in the cartridge and then you can complete the dose with a new cartridge. Refer to the INJECTING THE DOSE section above.

  • Page 27: Replacing A Used Insulin Cartridge

    11.1 The Screw will be extended once you have used the entire insulin cartridge. 11.2 Hold the InPen body and turn the Screw counterclockwise into the InPen Body until it stops. 11.3 Follow the instructions in PREPARING YOUR INSULIN INPEN section above.

  • Page 28: Cleaning Of Your Inpen

    Remove the Needle after every use. Do not store your InPen with the Needle attached. Do not store the InPen in a refrigerator. 13 Cleaning of Your InPen Cleaning removes dirt from the surface of the device. It does not kill bacteria or viruses.
  • Page 29 InPen. 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? •...

  • Page 30: Replacement

    Refer to the Patient Information provided with the Needle for information on this feature. 14 Replacement Your InPen will last for at least1 year after first use. Record the date your InPen was first used here: ____/____/____. Contact your healthcare provider to obtain a prescription for a new InPen.

  • Page 31: Supplemental Information31

    ISO 11608-1 Pen- Injectors for Medical use, Part 1: Requirements and test methods. 16.3 Applied Parts The InPen is a hand held device and is considered the applied part s defined by IEC 60601-1. 16.4 Declaration of Conformity...

  • Page 32: Warranty

    17 Warranty Companion Medical warrants the InPen System against defects in materials and workmanship for a period of 1 year from the date of purchase. During the warranty period, Companion Medical will, at its...
  • Page 33 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 and Privacy Policy (https://www.companionmedical.

  • Page 34: Product Specifications

    18 Product Specifications The InPen System is intended for use by patients at home and in healthcare facilities. Operating 5 °C (41 °F) to 40 °C (104 °F) Conditions 15 % to 93 % RH (non condensing) Operating -381 m (-1253 ft) to 3010 m...

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