EPG InsuJet Instructions For Use Manual

Insulin - jet administration system

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Insulin - Jet Administration System

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Page 1 Insulin - Jet Administration System Instructions for use...
Page 3 Please read this entire booklet before first use If you have any questions, contact your local distributor or visit the InsuJet™ website: www.insujet.com...
Page 5: Table Of Contents
» Installing the Adaptor » Installing a 3mL Adaptor » Installing a 10mL Adaptor Preparations for administration » Charging the InsuJet™ » Priming the InsuJet™ » Re-charge the InsuJet™ » Connecting the Adaptor to the Nozzle » Taking up insulin »...
Page 6: Introduction
The injector is designed for the administration of U-100 insulin, or saline solution for practice purposes. The InsuJet™ can be used to inject 4 to 40 units per administration, and is for single patient use only. Insulin in not provided with the...
Page 7: Product Description
Product description The InsuJet™ system is for people with diabetes and is used to administer insulin. The system works by positive displacement, i.e. by forcing insulin through a small orifice of a special Nozzle. This creates a thin, high pressure stream of insulin that penetrates the skin.
Page 8: Product Overview
Product overview The InsuJet™ package contains the following items: • InsuJet™ device • Comfort Ring • Carry Case • Instruction For Use booklet • Warranty Card InsuJet™ Nozzle Lock Nozzle Switch Lock Front Side Dosage Window Back Side Safety Switch...
Page 9 Consumables and accessories InsuJet™ consumables: NOTE: not included in the InsuJet™ package Nozzle 3mL Adaptor REF 01075 REF 01055 Nozzle Adaptor Adaptor Nozzle Cartridge Holder (not sterile) 10mL Adaptor REF 01065 Adaptor 10mL Adaptor InsuJet™ accessories: Comfort Ring REF 01223...
Page 10: Warnings
Warnings • The InsuJet™ should only be used for the administration of U100 insulins • The InsuJet™ should only be used with InsuJet™ Nozzles and Adaptors. • Check the expiration dates of your insulin. Do not use insulin past its expiration date.
Page 11 InsuJet™. Make sure that children are told that the InsuJet™ is not a toy. • Keep all medications and injection devices out of the reach of children. • Never use, or attempt to repair a damaged or broken InsuJet™ or consumable.
Page 12 Nozzle Lock Switch points to the locked position. This indicates that the Nozzle is secured. Replace the InsuJet™ in time. The same device should never be used for more than 5000 injections. Do not use the device past the indicated expiry date.
Page 13: Precautions
Precautions • Do not use the InsuJet™ other than described in this instruction for use. The manufacturer is not responsible for potential problems with products that are used in violation with this instruction for use. • Please consult your Diabetes Care Specialist when you change your insulin administration system.
Page 14: Good Injection Practices
Good injection practices • Wash your hands thoroughly before using the InsuJet™ • Clean the injection site as directed by your Diabetes Care Specialist. • Avoid unnecessary contact with the Nozzle tip or the areas on the consumables that come into contact with the insulin, to prevent possible contamination.
Page 15: Contraindications
InsuJet™; • Have a special skin type (e.g. psoriasis patients), which might impair a successful use of the InsuJet™. In case of doubt please consult your Diabetes Care Specialist. Patients who bruise or bleed easily (e.g.
Page 16: Operating Instructions - Preparation
Operating instructions - Preparation Installing the Nozzle While pushing the Nozzle Lock Switch upward, rotate the Nozzle Lock counterclockwise until the Nozzle Lock Switch points to the ´padlock unlocked´ icon. Remove the Nozzle from its packaging. Push the back of the Nozzle firmly into the open end of the device, until it cannot go further.
Page 17 Turn the Nozzle Lock clockwise. Make sure that the Nozzle Lock Switch points to the padlock locked position. NOTICE: If you cannot turn the Nozzle Lock to the locked position, please check if the Nozzle is installed correctly. Ensure that the Nozzle is pushed firmly into the device until it cannot go further.
Page 18: Installing The Adaptor
Installing the Adaptor There are different types of Adaptors available for the InsuJet™. These Adaptors are used to transport the insulin from an insulin cartridge or insulin vial into the Nozzle. • Use a 3mL Adaptor and Cartridge Holder if you want to use insulin from a 3mL cartridge.
Page 19 Example of a 3mL Example of a 10mL Adaptor with a 3mL Adaptor with a 10mL cartridge Vial Example of a 3mL Adaptor with a Disposable penfill NOTICE: For disposable penfill users, please refer to page 48 - 49 for instructions to install a 3mL Adaptor on a disposable penfill.
Page 20: Installing A 3Ml Adaptor
Installing a 3mL Adaptor Slide the 3mL cartridge into the Holder, with the bottom of the cartridge downward. Take the Adaptor and place it into the Holder. Make sure that the protrusions on the Adaptor and corresponding holes in the Holder are properly aligned.
Page 21: Installing A 10Ml Adaptor
Push firmly until the Adaptor snaps in place. The Adaptor remains on the Holder. Installing a 10mL Adaptor Remove the protective cap from the insulin vial. Push the 10mL Adaptor firmly onto the 10mL vial, until the Adaptor snaps in place. The Adaptor remains on the vial.
Page 22: Preparations For Administration
Preparations for administration Charging the InsuJet™ Notice the Nr1 and Nr2 arrows on the front of the device. Hold the device in both hands, one hand holding the front of the device, the other holding the back. It is advised to hold the device in one of the...
Page 23 Note that the amount of units in the Dosage Window should decrease. Continue to rotate the back until it will go no further. The InsuJet™ is charged when a green mark is visible in the Dosage Window.
Page 24: Priming The Insujet
Dosage Window. The front of the device should be easy to turn at this stage. Priming the InsuJet™ Prime your InsuJet™ every time you use a new Nozzle or new Adaptor. Priming reduces air bubbles inside the Nozzle. Remove the Nozzle Cap from the Nozzle and...
Page 25 Align the Adaptor with the Nozzle and firmly rotate the Adaptor clockwise until the Adaptor snaps in place. Tap the insulin cartridge or -vial firmly, to remove possible air bubbles from the needle opening inside the cartridge or vial.
Page 26 Hold the InsuJet™ with the insulin cartridge/ vial upwards and the Dosage Window facing you. On the front side of the InsuJet™ you will notice the number ‘2’ with a directional arrow. Hold the back of the device and turn the front in the direction of the Nr2 arrow until the number ‘5’...
Page 27 Disconnect the Adaptor with the insulin cartridge/vial from the Nozzle. Hold the device as shown. Be careful to point your InsuJet™ in such way that the Nozzle is facing down and away from people.
Page 28 Slide away the red Safety Catch as far as it will go and hold in place. While holding the red Safety Catch in place, push the Front Body towards the Back Body to expel the insulin from the Nozzle. Your device is now primed and ready to be filled.
Page 29: Re-Charge The Insujet
Nr1 arrow. As the device is being charged, some force will be required. Note that the amount of units in the Dosage Window should decrease. Continue to rotate the back until it will go no further. The InsuJet™ is now charged.
Page 30 While holding the back of the device, rotate the front in the direction of the Nr2 arrow, until the number ‘0’ re-appears in the Dosage Window. The front of the device should be easy to turn at this stage.
Page 31: Connecting The Adaptor To The Nozzle
Connecting the Adaptor to the Nozzle Remove the Nozzle Cap from the Nozzle and the Adaptor Cap from the Adaptor. Align the Adaptor with the Nozzle and firmly rotate the Adaptor clockwise until the Adaptor snaps in place.
Page 32 Tap the insulin cartridge or -vial firmly, to remove possible air bubbles from the needle opening inside the cartridge or vial.
Page 33: Taking Up Insulin
Taking up insulin Hold the InsuJet™ with the insulin cartridge/ vial upwards and the Dosage Window facing you. On the front side of the InsuJet™ you will notice the number ‘2’ with a directional arrow. 4...40 Hold the back of the device and turn the front in the direction of the Nr2 arrow to set the dosage.
Page 34 To remove possible air bubbles, start by disconnecting the Adaptor with the insulin cartridge/vial from the Nozzle. Keep the InsuJet™ upright, and tap the Nozzle firmly with your fingertips, collecting all air bubbles close to the opening.
Page 35 While holding the back of the device, gently rotate the front in the direction of arrow ‘1’. The air bubble and the excess of insulin will flow through the hole in the Nozzle. Continue to rotate until a drop of insulin becomes visible on top of the Nozzle.
Page 36 Check if the Nozzle is completely filled with insulin, before using the InsuJet™. 4 - 40 Before administration, always read the number of units in the dose window, to ensure you have set the correct dose.
Page 37: Administer Insulin
Administer insulin To administer your insulin, follow steps 1 to 7 below: Step 1 Select your administration site. See page 53 - 54 for administration sites and administration techniques. Wipe the chosen administration site with an alcohol swab. Let the skin dry before injection.
Page 38 It is recommended to use a Comfort Ring, in case you feel discomfort when pushing the Nozzle against the skin. To install a Comfort Ring, hold the device by its Front and place the Comfort Ring on top of the Nozzle. Make sure that the round side of the part is facing outward.
Page 39 Step 3 While you are holding the red Safety Catch in place, position the InsuJet™ perpendicular (90°) to the skin. Push the back of the device directly towards your chosen administration site. When enough pressure is generated, the device will...
Page 40 5 seconds, to prevent insulin leakage. NOTE: In case you experience pinprick bleeding after administration, please consider to continue pushing the Nozzle against the skin for up to 15 seconds. Step 5 Remove the InsuJet™ from the skin and release the red safety catch.
Page 41 Step 6 Evaluate the quality of your injection by the following guidelines: Visual: Pinprick bleeding at the injection site is quite normal. Some dampness around the injection site is acceptable, but if you see insulin running from the injection site, you should consider the injection incomplete.
Page 42: Replacing The Nozzle
Replacing the Nozzle Remove the Nozzle Cover from the Nozzle. While pushing the Nozzle Lock Switch upwards, turn the Nozzle Lock until the Nozzle Lock Switch points to the unlocked position.
Page 43 Pull the Nozzle out of the InsuJet™ with a firm straight pull. TIP: For additional grip during pulling, please connect an Adaptor to the Nozzle first. Loosen the internal part of the Nozzle by pushing it firmly to one side.
Page 44 Remove the internal part of the Nozzle. Discard the used Nozzle with your regular household waste. Firmly push a new Nozzle into the Nozzle Lock of the InsuJet™. You should hear and feel a ‘click’ when the Nozzle snaps in place.
Page 45 Once you have fully inserted the Nozzle, turn the Nozzle Lock until the Nozzle Lock Switch points to the locked position.
Page 46: Additional Information
additional information...
Page 47: Using A Comfort Ring
Using a Comfort Ring COMFORT RING The Comfort Ring is a round, plastic disc that can optionally be used to reduce the pressure of the Nozzle on the skin, for relatively soft or sensitive administration areas. Place the Comfort Ring on top of the Nozzle, just before administration.
Page 48: Using Insulin From A Disposable Penfill
Using insulin from a disposable penfill Example of a disposable penfill with a 3mL Adaptor...
Page 49 Take the 3mL Adaptor and place it on top of the disposable penfill. Push the Adaptor firmly onto the penfill until it is fixed. NOTICE: When attaching the Adaptor with a disposable penfill on the Nozzle, make sure to hold the Adaptor when rotating it onto the Nozzle.
Page 50: Different Types Of Nozzles & Adaptors
REF 01045 Nozzle 3mL Adaptor 10mL Adaptor REF 01075 REF 01055 REF 01065 All types of InsuJet™ Nozzles and Adaptors are compatible with one another. There are six types available. Refer to the packaging label for part identification and REF numbers.
Page 51 Using a 01035 or 01045 Adaptor with a 01075 Nozzle Push the Adaptor onto your insulin cartridge or vial until it snaps in place. Remove the Adaptor Cap and approach the Nozzle at an angle, connecting the clips of the Adaptor to the Nozzle at one side.
Page 52 Using a 01055 or 01065 Adaptor with a 01025 Nozzle Align the Adaptor and Nozzle. Firmly push the Adaptor on the Nozzle. The Adaptor snaps in place. To remove the Adaptor, pull the Adaptor from the Nozzle.
Page 53: Administration Site Selection Guide
Administration site selection guide NOTE: It is advised that your first InsuJet™ insulin administration takes place under the supervision of a Diabetes Care Specialist. Any of the sites that are normally recommended for your insulin administration can be used with the InsuJet™. Choose an area with some fatty tissue.
Page 54 Legs: Sit on a chair with the back of your legs supported and both feet flat on the floor. Relax your thigh muscle. The administration should take place on the front or outer portion of the thigh. Buttocks: Find a sitting position that allows you to reach the buttocks.
Page 55: Frequently Asked Questions & Answers
Frequently asked questions & answers How does the InsuJet™ administer insulin? The back of the InsuJet™ is rotated to compress a spring that is used to power the InsuJet™. The release of the spring forces insulin through a small orifice of a special Nozzle, creating a thin, high pressure stream of insulin that penetrates the skin.
Page 56 Specialist. These specialists can assess the suitability of the InsuJet™ for a particular individual and his or her environment. Is the InsuJet™ suitable for use by partially sighted? The InsuJet™ should only be used on the recommendation of a Diabetes Care Specialist.
Page 57 Will the InsuJet™ cause skin blistering or any other complications? The InsuJet™ may be used, but with caution, by anyone who bruises or bleeds easily. In the event of excessive bruising the usage of the InsuJet™ should be discontinued. The InsuJet™ will normally not...
Page 58: Troubleshooting
This section is designed to provide you with tips on solving minor problems which you may encounter when you use the InsuJet™ system. Bleeding A tiny pinprick bleed following administration is not unusual for some people and can simply be wiped off.
Page 59 Raised white bump This may indicate that, while successful, your administration did not penetrate sufficiently into your skin. If this happens, practice your administration technique. If you require a relatively large amount of insulin, it may be worth splitting your dose; E.g.
Page 60 Possible side effects of insulin injection Insulin side effects amongst diabetics are rare, but when they occur, allergic reactions can be severe and pose a significant risk to health. Always read the patient information leaflet of your prescribed insulin. The possible side effects are listed in this leaflet.
Page 61 • Keep the top of the Nozzle perpendicular (at an angle of 90º) relative to the administration site. • Keep the InsuJet™ steady throughout the administration. • After the injection, keep pressing the InsuJet™ onto the administration site for at least 5 seconds.
Page 62 Unable to aspirate insulin from insulin vial or cartridge If you experience problems aspirating insulin from your cartridge or vial, please check the following three items: 1. Check if the Adaptor is correctly installed on the Nozzle. Look from the side and inspect the position of the black Plunger tip (inside the Nozzle), relative to the Adaptor.
Page 63 2. Check if a white, round part is visible when viewing into the Adaptor from the top. If not, replace the Adaptor. 3. Check if the needle of the Adaptor pierced the septum of the cartridge or vial completely. The needle should be visible on the inside of the cartridge or vial.
Page 64 Unable to install the Nozzle into the InsuJet™ If you can’t push the Nozzle into the Nozzle Lock, it may still be in the locked position. Before inserting the Nozzle, please ensure that the Nozzle Lock Switch points to the unlocked position.
Page 65 To remove the air from the Nozzle, first remove the Adaptor with the cartridge or vial from the Nozzle. Keep the InsuJet™ upright. While holding the back of the device, rotate the front in the direction of arrow ‘1’ until the green marking is visible in the Dosage Window.
Page 66: Maintenance
Maintenance • Handle the InsuJet™ with care. Do not drop the device or the consumables. • To clean the InsuJet™, wipe the exterior with a damp cloth. • Do not immerse the InsuJet™ in liquid. • Place the Nozzle Cap on the Nozzle, after each administration.
Page 67: Storage
Storage -or- • Store the device inside the Carry Case. • Store the InsuJet™ in dry conditions between 5°C and 40°C. • Do not store the system in the refrigerator or in a damp area. Dampness may affect the device and cause corrosion.
Page 68: Symbol Glossary
Symbol glossary Symbol Title Description / Standard Ref. No. Explanatory Text of Symbol Manufacturer Indicates the ISO 15223-1:2016 5.5.1 medical device manufacturer Date of Indicates the date ISO 15223-1:2016 5.1.3 Manufacture when medical device was manufactured Use by Date Indicates the date ISO 15223-1:2016 5.1.4 after which device...
Page 69: Product Specifications
Indicates a medical ISO 15223-1:2016 5.6.3 pyrogenic device that is non- pyrogenic Product specifications The InsuJet™ is a spring-powered needle- free device, designed for subcutaneous administration of insulin. The InsuJet™ system is designed for single person usage only. Weight: InsuJet™ Approx. 140g...
Page 70: Replacement
Replacement The InsuJet™ is a so-called ‘active’ medical device, meaning that its mechanical function will eventually deteriorate to a point that safe and comfortable administration can no longer be performed with it. Replace your InsuJet™ device in time. The same device should never be used for more than 5000 injections, or past the Use-by date that is shown below.
Page 72: Contact Details Insujet™ Dealer
Contact details InsuJet™ dealer Euro Offices Building 3rd Floor Beechavenue 127, 1119 RB Schiphol-Rijk The Netherlands 012000-EN-8.2 www.insujet.com | info@insujet.com 21 June 2018 Copyright © European Pharma Group BV...