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PRODUCT OVERVIEW

The InsuJet™ Basic Starter Pack
contains the following items:

•  1 InsuJet™ pen
•  1 Nozzle
•  1 Nozzle cover
•  1 Vial (10mL) Adaptor
•  1 Cartridge (3mL) Adaptor
•  1 Cartridge Cap Removal key
•  1 Carry pouch
•  1 Instruction for use booklet

INSUJET™ PEN

DOSAGE WINDOW;
for displaying the amount of
insulin units.

NOZZLE LOCK; assuring a safe

connection with the nozzle.

RED SAFETY CATCH;
safety mechanism to ensure

that the device does not fire

prior to placement to the
administration site.

Содержание Basic Starter Pack

Страница 1: ...instructions for use Insulin Jet Administration System ...

Страница 2: ...steps Read the entire InsuJet instructions for use before you start using the InsuJet Also read the instructions for use if you are already familiar with the device Please note that an individual InsuJet training session with a Diabetes Care Specialist is highly recommended After having studied the InsuJet guidelines first practice with test fluid in order to become familiar with the InsuJet The f...

Страница 3: ...o ensure safe administration with the device REMOVING THE NOZZLE How to replace the disposable nozzle Please note that all pictures are shown for right handed operation From experience it is known that left handed people are able to handle the InsuJet safely and comfortable as well If you have any questions contact your local distributor or visit the InsuJet website www insujet com ...

Страница 4: ... Cartridge 3mL Adaptor 1 Cartridge Cap Removal key 1 Carry pouch 1 Instruction for use booklet INSUJET PEN DOSAGE WINDOW for displaying the amount of insulin units NOZZLE LOCK assuring a safe connection with the nozzle RED SAFETY CATCH safety mechanism to ensure that the device does not fire prior to placement to the administration site ...

Страница 5: ... 10ML ADAPTOR to transport the insulin from a 10mL vial into the disposable nozzle CARTRIDGE CAP DISPOSER KEY to remove the coloured cartridge cap from certain 3mL cartridges NOZZLE COVER to protect the nozzle when not in use 3ML ADAPTOR to transport the insulin from a 3mL cartridge into the disposable nozzle ...

Страница 6: ...nstalling the adaptor Preparing the InsuJet for administration Charging the device Connecting the adaptor to the nozzle Taking up insulin ADMINISTRATION Administer insulin with the InsuJet Replacing the nozzle 8 11 15 15 18 20 25 30 INDEX ...

Страница 7: ...NFORMATION Important Administration site selection guide Removing the coloured cartridge cap Frequently asked questions and answers Troubleshooting Contraindications Cautions and warnings Maintenance and care Product specifications Symbol legenda ...

Страница 8: ...ice changing from locked to unlocked position In unlocked position a nozzle can be inserted into the device The Nozzle lock contains a plastic switch which needs to be pushed upwards as illustrated in the picture The Nozzle lock is then free to turn Turn the Nozzle lock so that the arrow points towards the opened lock symbol to prepare the device for inserting the nozzle ...

Страница 9: ...packed nozzle by the label on its packaging Remove the nozzle from its packaging and install the back of the nozzle into the open end of the InsuJet device as illustrated You should hear and feel a click as the nozzle engages ...

Страница 10: ...10 Once you have fully inserted the nozzle turn the nozzle lock to the left Ensure that the nozzle lock arrow points to the padlock locked position ...

Страница 11: ...nsporting the insulin from most conventional vials and cartridges into the nozzle If you want to use insulin from a 3mL cartridge please use the 3mL cartridge adaptor If you want to use insulin from the 10mL vial please use the 10mL vial adaptor The adaptors are packed in a sterile packaging Remove the adaptor from the packaging after identifying the correct content ...

Страница 12: ...12 3mL adaptor with 3mL cartridges Penfill is a registered trademark of Novo Nordisk A S 10mL adaptor with 10mL Vial ...

Страница 13: ...n cartridge vial making sure that the plastic needle of the adaptor pierces the rubber septum on top of the insulin cartridge vial NOTICE For Novo Nordisk Penfill users Please refer to the additional information on page 40 41 for an instruction to remove the coloured cartridge cap by using the cartridge cap removal key ...

Страница 14: ...14 The adaptor should firmly snap onto the cartridge vial The adaptor remains on the cartridge vial ...

Страница 15: ...EPARING THE INSUJET FOR ADMINISTRATION CHARGING THE DEVICE Notice the Nr1 and Nr2 arrows on the device The Nr2 arrow is located on the top of the device and the Nr1 arrow is located on the back of the device ...

Страница 16: ...16 To charge the device hold the device in two hands one hand holding the top of the device the other hand holding the back You can hold the InsuJet as shown on the left or as shown below ...

Страница 17: ... the Nr1 arrow Some force will be required at this stage to charge the device The amount of units in the dose window should decrease Rotate the back untill it will go no further A green marking will appear in the dosage lens When this happens you will also feel and hear a click The InsuJet is now charged ...

Страница 18: ...tor Also make sure that the nozzle cover is removed from the nozzle While holding the back of the device rotate the top in the direction of the Nr2 arrow untill the number 0 re appears in the dosage window CONNECTING THE ADAPTOR TO THE NOZZLE ...

Страница 19: ... nozzle First approach the nozzle at an angle connecting the clips of the adaptor to the nozzle at one side After connecting the clips of the adaptor to the nozzle tilt the adaptor and cartridge vial upright The adaptor should snap to the nozzle ...

Страница 20: ...dose of insulin appears in the dose window The top of the device should be easy to turn at this stage For each unit that is taken into the nozzle you will notice a notch Hold the InsuJet with the insulin cartridge vial upwards and the dose window facing you On the top of the InsuJet you will notice the number 2 with a directional arrow TAKING UP INSULIN ...

Страница 21: ... wind the InsuJet beyond the 40 units indication because it may damage the InsuJet beyond repair and even cause injury VERY IMPORTANT Always take in some extra insulin into the nozzle to compensate for possible air bubbles ...

Страница 22: ...the InsuJet upright Tap the nozzle firmly with your finger tips collecting all air bubbles close to the opening To remove possible air bubbles disconnect the insulin cartridge vial and adaptor from the InsuJet ...

Страница 23: ...air bubble and the excess of insulin will flow through the hole in the nozzle An insulin drop will be visible on top of the nozzle when all air is removed If the insulin drop doesn t appear re connect the vial or cartridge aspirate some additional insulin from it and repeat the steps mentioned in this section ...

Страница 24: ...e administration always read the number of units in the dose window to check you have the correct dose Always ensure that the nozzle is completely filled with insulin or test fluid before using the InsuJet IMPORTANT ...

Страница 25: ...25 ADMINISTER INSULIN WITH THE INSUJET Step 1 Select your administration site See page 38 39 for administration sites and administration techniques To administer your insulin follow steps 1 to 6 below ...

Страница 26: ...afety catch as far as it will go and hold it in place Step 3 While you are holding the red safety catch in place push the back towards your chosen administration site Make sure that the InsuJet is held at right angles 90 to the skin ...

Страница 27: ...rpendicular to the administration site When a sufficient amount of pressure is generated the device will automatically activate the insulin administration Best practice indicates that these handlings should be performed in a fluent manner one action ...

Страница 28: ...28 5 sec Step 4 After the administration please hold the nozzle firmly against the skin for at least 5 seconds Step 5 Remove the InsuJet from the skin and release the red safety catch ...

Страница 29: ...29 Step 6 Place the adaptor cover back on the adaptor until the next usage Store your insulin according the guidelines of your insulin supplier Place the nozzle cover back on the nozzle ...

Страница 30: ...e cover from the nozzle IMPORTANT The same nozzle should never be used for more than 60 injections or longer than 14 days It is advised to replace the nozzle every time a new cartridge or vial is used REPLACING THE NOZZLE ...

Страница 31: ...31 Pull the nozzle out of the InsuJet with a straight firm pull While pushing the nozzle lock switch upwards turn the nozzle lock until the nozzle lock arrow points to the padlock unlocked position ...

Страница 32: ...32 Remove the internal part of the nozzle Discard the used nozzle with your regular household waste Loosen the internal part of the nozzle from the InsuJet by pushing it firmly to one side ...

Страница 33: ...et You should hear and feel a click as the nozzle engages Once you have fully inserted the nozzle turn the nozzle lock to the left until the nozzle lock arrow points to the padlock locked position IMPORTANT Ensure that the nozzle lock arrow points to the padlock locked position ...

Страница 34: ......

Страница 35: ...35 additional information ...

Страница 36: ...est care However being a mechanical instrument it may eventually fail to operate properly Always make sure you have access to alternative insulin delivery systems Do not attempt to wind the device beyond the 40 units indication Attempting to dismantle the InsuJet may damage the device beyond repair Always remove all air from the nozzle before firing the device Never release the InsuJet without the...

Страница 37: ...indicated limitation and damage to the device may occur Never use the same nozzle or cartridge or vial adaptor for different patients Never use the same cartridge or vial adaptor for different insulin cartridges of vials Please consult your Diabetes Care Specialist when you change your insulin administration system Make sure to carefully monitor your blood glucose levels before using the InsuJet a...

Страница 38: ... 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 Avoid areas with a low fat content e g the shinbone or high muscle content upper arm Abdomen use the areas on the same level as or slightly below your navel as illustrated on the right To avoid ...

Страница 39: ...ith 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 The administration should take place in the upper outer portion of your buttock Some patients may experience pinprick bleeding at the administration site and...

Страница 40: ...emark of Novo Nordisk A S screw the coloured cartridge cap into the cartridge cap removal key For Novo Nordisk Penfill users Remove the coloured cartridge cap by using the cartridge cap removal key REMOVING THE COLOURED CARTRIDGE CAP ...

Страница 41: ...41 pull off the coloured cartridge cap from the Penfill with a straight firm pull discard the coloured cartridge cap with your regular household waste ...

Страница 42: ...sulin administration device Can I switch to the InsuJet Yes You can switch to the InsuJet but like any changes in the management of your diabetes the changeover period needs to be carefully monitored and the Diabetes Care Specialist who is involved in your care should be consulted I am interested in using the InsuJet Should I discuss with my Diabetes Care Specialist about switching to the InsuJet ...

Страница 43: ...nners can be loaded into the InsuJet using the appropriate adaptors Is the InsuJet suitable for children and the elderly The InsuJet should only be used on the recommendation of a Diabetes Care Specialist These specialists are in a position to assess the suitability of the InsuJet for a particular individual and his environment Is the InsuJet suitable for use by partially sighted The InsuJet shoul...

Страница 44: ...InsuJet A competent caregiver can help assist the severely visually impaired person with using the InsuJet 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 But in the event of excessive bruising the usage of the InsuJet should be discontinued The InsuJet will normally not cause blistering But anyone wh...

Страница 45: ...the administration site following insulin administration indicates that an incomplete dose of insulin was given The cause of a wet injection is in most cases related to the injection technique of the user The main points to consider when perfecting your administration technique are the following Keep the top of the nozzle perpendicular at an angle of 90º relative to the administration site Keep th...

Страница 46: ...pens practice your administration technique It may be worth splitting your insulin dose if you are currently taking a larger dose so that you are making smaller insulin administrations e g if you currently take 40 units in one administration try 2 doses of 20 units instead Bleeding A tiny pinprick bleed following administration is not unusual for some people and can simply be wiped off If a larger...

Страница 47: ...he InsuJet as well In this case it may be worth splitting your insulin dose if you are currently taking a larger dose so that you are making smaller insulin administrations e g if you currently take 40 units in one administration instead try 2 doses of 20 units each Uncomfortable administration Similar to administration with a needle an uncomfortable administration may occur if you administer insu...

Страница 48: ...cut itself through the septum Unable to draw insulin from insulin vial or cartridge If you experience problems drawing insulin from your cartridge or vial please ensure that the spike of the adaptor pierced the septum of the insulin cartridge or vial completely The spike should be visible on the inside of the cartridge or vial as illustrated below ...

Страница 49: ...the cartridge or vial from the nozzle CAUTION Never release the InsuJet with air inside the nozzle This is called DRY FIRING and can damage the InsuJet beyond repair Keep the InsuJet upright While holding the front of the device rotate the back in the direction of arrow 1 untill the green marking is visible in the dosage lens Follow the steps described in the section PREPARING THE INSUJET FOR ADMI...

Страница 50: ...ed position before inserting the nozzle Besides the icons on the nozzle lock you can also look from above into the device You will see two triangular parts In unlocked position the two parts are aligned allowing the nozzle with its triangular shapes into the nozzle lock After the nozzle is completely pushed into the mechanism the second triangular part will lock the nozzle UNLOCKED POSITION LOCKED...

Страница 51: ...sing the InsuJet difficult 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 Are not able to understand or memorise the procedure for using the InsuJet Are not willing to fully comply with the procedures for using the InsuJet and with the recommended frequency for replacement of the acces...

Страница 52: ...on for use The manufacturer is not responsible for potential problems with the device when the instructions are not carefully followed Never try to repair a broken InsuJet Patients who bruise or bleed easily e g people using antithrombotic drugs may use the device with caution Discontinue usage if excessive bruising or bleeding is experienced InsuJet use might lead to a decreased daily insulin nee...

Страница 53: ... Adult supervision is highly recommended when a child uses the InsuJet Make sure that children are told that the InsuJet is not a toy Device performance and safety may be affected when using the nozzle beyond indicated limitation and damage to the device may occur ...

Страница 54: ...t of sunlight and do not store the device in the refrigerator When flying we recommend that you store the InsuJet in your hand luggage The nozzle should never be used for more than 60 injections or longer than 14 days It is advised to replace the nozzle every time a new cartridge vial is going to be used Replace the nozzle whenever the InsuJet has not been used for more than 3 days When flying or ...

Страница 55: ... nozzle After drawing insulin into the nozzle always place the vial cartridge adaptor cover back on the vial cartridge adaptor Discard the vial cartridge adaptor along with each empty insulin cartridge vial During nozzle replacement regularly clean the metal coloured surface that is visible when looked into the top of the device Use a dry tissue to gently wipe the surface clean as shown below ...

Страница 56: ...ht InsuJet Approx 140g Size length 140mm 160mm Dose Range 4 40 international units of U100 insulin per administration Dose Scale Graduation 1 unit increments Administration Duration less than 0 3 seconds Insulin Concentration the InsuJet is calibrated for U100 insulin Insulin Types human and animal analogue long and short acting soluble isophane premixtures e g 30 70 Storage between 5 C and 40 C ...

Страница 57: ...57 CONSULT INSTRUCTIONS FOR USE CAUTION MANUFACTURER BATCH CODE USE BY STERILIZED USING ETHYLENE OXIDE TEMPERATURE LIMITS DO NOT USE IF PACKAGE IS DAMAGED DO NOT RESTERILIZE SYMBOL LEGENDA ...

Страница 58: ...58 ...

Страница 59: ......

Страница 60: ...012000 UK 6 0 European Pharma Group BV Euro Offices Building 3rd Floor Beechavenue 127 1119 RB Schiphol Rijk The Netherlands www insujet com info insujet com Copyright European Pharma Group BV ...

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