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Nemera Teripen 2 User Manual

Reusable teriparatide pen injector
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REUSABLE TERIPARATIDE PEN INJECTOR
Teripen 2
T eripen 2
USER'S MANUAL
®

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Summary of Contents for Nemera Teripen 2

  • Page 1 0 1 9 7 REUSABLE TERIPARATIDE PEN INJECTOR Teripen 2 T eripen 2 USER'S MANUAL ®...

  • Page 2: Table Of Contents

    Table of content before the first use construction of pen injector, pen needle and cartridge installation of cartridge and pen needle priming your Teripen 2 injecting a dose removing a needle replacing a cartridge replacing a needle storage and cleaning...

  • Page 3: Before The First Use

    Before the first use of Teripen 2 pen injector carefully read ALL instructions included in this user's manual. Teripen 2 is a reusable, intuitive automatic teriparatide injector. It provides you or your child with a precise, safe and effortless way to administer teriparatide doses recommended by the doctor, in the range from 2,5 to 20 micrograms (mcg), with incremental dose of 2,5 mcg.
  • Page 4 construction of the pen injector window displaying the pen body end of the injection release button pen cap window of cartridge holder cartridge holder plunger selector window dose rubber cartridge tip inner needle shield needle selector teriparatide pen needle cartridge outer needle shield paper tab metalic cartridge cap...

  • Page 5: Installation Of Cartridge And Pen Needle

    Wash your hands with soap thoroughly, and make sure that you have the following items: Teripen 2 pen injector teriparatide cartridge new disposable pen needle two alcohol swabs Step 1 Pull off the cap...
  • Page 6 installation of cartridge and pen needle Step 3 Press the plunger into the pen body Step 4 Check the teriparatide cartridge. Make sure that it is not cracked or broken, the teriparatide solution is clear and transparent and check the medicine expiration date.
  • Page 7 installation of cartridge and pen needle Step 5 Insert teriparatide cartridge into the cartridge holder, metallic tip to the front. Step 6 Attach the cartridge holder to the pen body by turning it according to direction shown on the drawing, until first resistance is met.
  • Page 8 installation of cartridge and pen needle Step 7 Take a new sterile needle and remove the paper tab from the outer needle shield. For each injection use a new needle. Do not use needles if the paper cover if damaged. Reuse of the same needle or needle with a damaged unit pack (paper cover) is not in line with epidemiological recommendations.
  • Page 9 installation of cartridge and pen needle Step 9 Remove the outer needle shield. Retain it for removal of the needle after the completion of the injection process. Step 10 Remove the inner needle shield as recommended by the manufacturer. To minimise the risk of unintended needle penetration and transmission of infectious diseases, never replace the inner needle shield once removed.
  • Page 10 Prime your Teripen 2 before each injection. Hold Teripen 2 with needle pointing up.Tap lightly with your finger on the cartridge holder to move any air bubbles in the cartridge to the top of the cartridge. Step 11 The number in the dose selector window corresponds to the drug volume in micrograms (mcg).

  • Page 11: Injecting A Dose

    injecting a dose Step 13 Select a dose of teriparatide you want to inject. To do that, turn the dose selector according to the direction shown on the drawing, until the desired figure corresponding to the number of teriparatide mcg appears in the dose selector window. Make sure that dose selector window shows the correct number of doses.
  • Page 12 injecting a dose Step 15 Gently hold a fold of the skin and insert the tip of the needle into subcutaneous tissue in a 90 degrees angle. Using your thumb slide the release button in the needle direction, hold the release button until a green dot appears in the window displaying the end of injection.

  • Page 13: Removing A Needle

    injecting a dose Step 16 Remove the needle from the skin at the same angle it was inserted into subcutaneous tissue. removing a needle Step 17 After the injection put the outer needle shield on the needle. Holding the cartridge holder rotate the outer needle shield according to the direction shown on the drawing.

  • Page 14: Replacing A Cartridge

    Step 18 Put the cap on the pen injector. The teriparatide injection has been completed. replacing an empty cartridge Remove the cartridge holder from the pen body by turning it according to the direction shown on the drawing. Shake the empty cartridge and remove it in accordance with information provided by the manufacturer of teriparatide.

  • Page 15: Storage And Cleaning

    Teripen 2 should always be stored and carried with the pen cap on, without a needle. Teripen 2 with the teriparatide cartridge should be refrigerated at +2°C to +8°C. Teripen 2 without the teriparatide cartridge, can be stored at -40°C to +70°C.
  • Page 16 Troubleshooting Troubleshooting Possible cause: HOW TO ELIMINATE: Problem: User error. You can correct the dose by turning the A higher dose dose selector in the opposite direction. was dialled then required. Possible cause: HOW TO ELIMINATE: Problem: Check if the cartridge was properly Incorrectly insert Cannot attach the cartridge Nie mogę...
  • Page 17 Troubleshooting HOW TO ELIMINATE: Possible cause: Problem: Check if the cartridge was properly Despite a number of priming Incorrectly installed installed. There should be no space procedures a drop of teriparatide cartridge. between the plunger and the cartridge. teriparatide has not appeared on the end of the needle.

  • Page 18: Information From The Manufacturer

    Teripen 2 meets the requirements of ISO 11608-1 standard with respect to general requirements dosing accuracy and robustness. Teripen 2 in intended for use with disposable needles: BD Micro-Fine 0.25mm x 5mm, BDMicro-Fine 0.23mm x 4mm and BD Micro-Fine 0.25mm x 8mm.
  • Page 19 legend Indicates the medical device manufacturer (red color) Indicates that caution is necessary when operating the device or control close to where the symbol is placed or that the current situation needs operators awareness or operator action in order to avoid undesirable consequences Indicates the need for the user to consult the instructions Patient information website...
  • Page 20 notes...
  • Page 21 Remember to dispose Your pen injector 2 years after first use. Below note the date of first and last use of Teripen 2 use on: Throw away after:...
  • Page 22 Read the instructions carefully before using Teripen 2. Failure to follow of these instructions may have serious consequences to your health. Using the device in a different way from the process described in this manual is REUSABLE TERIPARATIDE PEN INJECTOR not recommended.