Insulin - Jet Administration System. instructions for use

Transcription

1 Insulin - Jet Administration System instructions for use

2 INTRODUCTION Thank you for choosing the InsuJet, a European-designed insulin-jet administration system, developed with your comfort and convenience in mind. The InsuJet is designed to be used with InsuJet nozzles and adaptors and is calibrated for use with U100 insulins. Before you start using the InsuJet, please ensure that you are familiar with the device by carrying out the following 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 first part of this instruction will guide you through the process of using the InsuJet needle free device. The instruction covers the following steps, crucial for the operation of the device;

3 PREPARATION; Installing the nozzle Installing the adaptor on the insulin cartridge/vial Charging the device Connecting the adaptor to the nozzle Taking up insulin ADMINISTRATION; How to ensure safe administration with the device 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: REMOVING THE NOZZLE; How to replace the disposable nozzle

4 PRODUCT OVERVIEW INSUJET PEN 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 NOZZLE LOCK; assuring a safe connection with the nozzle. DOSAGE WINDOW; for displaying the amount of insulin units. RED SAFETY CATCH; safety mechanism to ensure that the device does not fire prior to placement to the administration site.

5 DISPOSABLE NOZZLE AND ADAPTORS NOZZLE COVER; to protect the nozzle when not in use. 3ML ADAPTOR; to transport the insulin from a 3mL cartridge into the disposable nozzle. 5 NOZZLE; for administrating the insulin through a small orifice into the body. 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.

6 INDEX 6 PREPARATION Installing the nozzle Installing 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 25 30

7 ADDITIONAL INFORMATION 7 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

8 8 INSTALLING THE NOZZLE The Nozzle lock, the metal part at the end of the InsuJet device, is illustrated in the image on the left. This part can be turned relative to the device, 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.

9 Identify the sterile 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. 9 You should hear and feel a click as the nozzle engages.

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.

11 INSTALLING THE ADAPTOR There are two types of adaptors available for the InsuJet needle free device. These adaptors help transporting the insulin from most conventional vials and cartridges into the nozzle. 11 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. VIAL (10mL) adaptor CARTRIDGE (3mL) adaptor

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

13 NOTICE For Novo Nordisk Penfill users: Please refer to the additional information on page for an instruction to remove the coloured cartridge cap by using the cartridge cap removal key; 13 The illustration shows a cartridge adaptor (3mL) with an insulin cartridge. Push the adaptor over the end of the insulin cartridge/vial, making sure that the plastic needle of the adaptor pierces the rubber septum on top of the insulin cartridge/vial.

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

15 PREPARING THE INSUJET FOR ADMINISTRATION 15 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.

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.

17 While firmly holding the top of the device, start rotating the back of the device in the direction of 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. 17 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.

18 18 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 Remove the adaptor cover from the adaptor. Also make sure that the nozzle cover is removed from the nozzle.

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

20 TAKING UP INSULIN 20 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 Hold the back of the device with one hand and turn the top of the device with the other hand in the direction of the Nr2 arrow, until your desired 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.

21 Always take in some extra insulin into the nozzle, to compensate for possible air bubbles. 21 VERY IMPORTANT Do not attempt to wind the InsuJet beyond the 40 units indication, because it may damage the InsuJet beyond repair and even cause injury.

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

23 While holding the top of the device, gently rotate the back of the InsuJet in the direction of arrow 1. The air bubble and the excess of insulin will flow through the hole in the nozzle. 23 An insulin drop will be visible on top of the nozzle when all air is removed. If the insulin drop doesn t appear, reconnect the vial or cartridge, aspirate some additional insulin from it and repeat the steps mentioned in this section.

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

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

26 26 Step 2 Slide away the red safety 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.

27 IMPORTANT Ensure that the InsuJet is held perpendicular to the administration site. 27 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)

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.

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. 29 Place the nozzle cover back on the nozzle.

30 30 REPLACING 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. Remove the nozzle cover from the nozzle.

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

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

33 Firmly push a new nozzle into the opening in the nozzle lock of the InsuJet. You should hear and feel a click as the nozzle engages. 33 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.

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35 additional information 35

36 36 IMPORTANT Handle the InsuJet with care. Do not drop the device or the consumables. Store the device inside the carry case when not in use. Check the expiration dates of the InsuJet Consumables on the outer packaging. The InsuJet is designed and manufactured with greatest 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 nozzle attached. Check the dosage setting before each administration.

37 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. Device performance and safety may be affected when using the nozzle beyond 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 and for an appropriate amount of time thereafter. 37

38 38 ADMINISTRATION SITE SELECTION GUIDE Advised is 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. 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

39 a wet injection, make sure that your abdominal administration site is not too soft. The nozzle and piston must be placed on a firm skin area (e.g. a skinfold). If you are unable to find a qualified abdominal administration site, please consider an administration area with a more firm underlay (e.g. the thigh). 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. The administration should take place in the upper outer portion of your buttock. Some patients may experience pinprick bleeding at the administration site and/ or notice a temporary white or reddish area around the administration site.this is quite normal and is nothing to worry about. 39

40 40 REMOVING THE COLOURED CARTRIDGE CAP For Novo Nordisk Penfill users: Remove the coloured cartridge cap by using the cartridge cap removal key; screw the coloured cartridge cap into the cartridge cap removal key; Penfill is a registered trademark of Novo Nordisk A/S.

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

42 42 FREQUENTLY ASKED QUESTIONS AND ANSWERS How does the InsuJet administer insulin? The back of the InsuJet is rotated to wind up a spring that is used to power the InsuJet. The release of the spring forces a fine stream of insulin through an orifice in the nozzle at high pressure. The insulin jet penetrates the skin and enters the subcutaneous layer of tissue. I am currently using an alternative insulin 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? Yes. You should involve your Diabetes Care Specialist in any discussion and decision relating to switching to the InsuJet.

43 Will I have to change my type of insulin in order to use the InsuJet? Generally speaking, you will continue to use the insulin prescribed to you, so there should be no change in the types of insulin used. Which insulin vial and cartridge sizes are suitable for use with the InsuJet? At present one type of vial adaptor for 10mL insulin vials and a different type of cartridge adaptor for 3mL insulin cartridges is available. Insulins supplied in these manners 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 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 their environment. If the Diabetes Care Specialist is happy for the InsuJet to 43

44 44 be used by either the partially-sighted individual or the partially-sighted individual s caregiver, there is no reason why it should not be used. There is a magnified dose window to allow the dose units to be easily read by most people. It is not recommended that anyone who is severely visuallyimpaired or legally blind self-administer using the 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 who has a skin condition associated with the administration sites to be used, should consult his Diabetes Care Specialist before switching to the InsuJet.

45 TROUBLESHOOTING The InsuJet is a mechanical instrument which is manufactured with greatest care. However, it may eventually fail to operate properly. Always make sure you have easy access to an alternative insulin delivery system. This section is designed to provide you with tips on how to solve minor problems which you may encounter when you use the InsuJet system. Wet injection Excessive moisture at 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 the InsuJet steady throughout the administration. After the injection, keep pressing the InsuJet onto the administration site for at least 5 seconds. Always make sure that there are no air bubbles in the nozzle. 45

46 46 In case of a wet injection, you should monitor your blood glucose levels carefully and adjust your next dose accordingly. If you notice constant insulin leakage during administration, stop using the InsuJet immediately and revert to your alternative insulin administration method. Please contact your Diabetes Care Specialist. Raised white bump This may indicate that, while successful, your administration did not penetrate far enough into your skin. If this happens, 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 amount of blood is present you may have hit a capillary, which is unlikely to happen next time. Apply pressure to the administration site. This will usually stop the bleeding. Bruising If you are a person who tends to bruise easily with a needle-based device you

47 may bruise with the 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 insulin close to a nerve ending. This cannot be foreseen, although individual persons may find that particular areas feel more sensitive, in which case these areas should be avoided. Red marking in the dosage lens A red marking will appear in the lens window in case the device is accidentally winded beyond 40 units. To return to 40 units and below, first remove the adaptor with the cartridge or vial from the nozzle. Hold the back of the device, and rotate the front into the opposite direction of the Nr2 arrow, to reduce the dose level. 47

48 48 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. If the spike did not pierce the septum completely, push the adaptor another time onto the septum, combined with a rotating movement. The spike will cut itself through the septum.

49 Excessive amount of air inside nozzle If you experience problems drawing insulin from your cartridge or vial, it is likely that the nozzle contains an excessive amount of air. 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. 49 To remove the air from the nozzle, first remove the adaptor with the cartridge or vial from the nozzle. Follow the steps described in the section PREPARING THE INSUJET FOR ADMINISTRATION to draw insulin into the nozzle.

50 50 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. Please ensure that the nozzle lock arrow points to the padlock unlocked 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 POSITION

51 CONTRAINDICATIONS This product is not recommended for patients who: Are severely visually impaired; Have impaired dexterity or/and have neuromuscular or arthritic conditions which would make winding and using 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 accessories. 51

52 52 CAUTIONS & WARNINGS Always ensure you have an alternative insulin administration system available, in case the InsuJet gets lost or broken. The InsuJet should only be used for the administration of insulin. Do not use the InsuJet other than described in this instruction 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 need compared to a needle-based insulin delivery system. Always monitor

53 your blood glucose levels carefully to avoid a hypoglycaemia. 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.

54 54 MAINTENANCE & CARE To clean the InsuJet, wipe the exterior with a damp cloth. Do not immerse the InsuJet in liquid. Store the InsuJet in dry conditions between 5 C and 40 C. Store the device inside the carry case when not in use. Store the device out 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 in the event of sudden pressure or temperature

55 changes, keep the vial/cartridge adaptors upright, with the base of the vials turned downward, to prevent leakage of insulin from the vials. After each administration, place the nozzle cap on the 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. 55

56 56 PRODUCT SPECIFICATIONS Description: The InsuJet is a spring-powered needle-free device, designed for subcutaneous administration of insulin. The device is designed for single person usage only. Weight: 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

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

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