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Содержание InsuJet

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

Страница 2: ......

Страница 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...

Страница 4: ......

Страница 5: ...harging the InsuJet 22 Priming the InsuJet 24 Re charge the InsuJet 29 Connecting the Adaptor to the Nozzle 31 Taking up insulin 33 Administer insulin 37 Replacing the Nozzle 42 Additional information...

Страница 6: ...n The InsuJet system is intended for the subcutaneous jet injection of U 100 insulin in adults and children The injector is designed for the administration of U 100 insulin or saline solution for prac...

Страница 7: ...orifice of a special Nozzle This creates a thin high pressure stream of insulin that penetrates the skin In this manner the insulin is deposited into the subcutaneous tissue All pictures in this manua...

Страница 8: ...The InsuJet package contains the following items InsuJet device Comfort Ring Carry Case Instruction For Use booklet Warranty Card Nozzle Lock Nozzle Lock Switch Front Side Dosage Window Back Side Saf...

Страница 9: ...not included in the InsuJet package Adaptor Cap Adaptor Cap Nozzle Nozzle Cap Comfort Ring REF 01223 10mL Adaptor 3mL Adaptor not sterile InsuJet accessories Nozzle REF 01075 3mL Adaptor REF 01055 10...

Страница 10: ...reached Never use the same Nozzle for different types of insulin Never use the same cartridge or vial Adaptor for different insulin cartridges or vials Discard the Adaptor with the empty insulin cartr...

Страница 11: ...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 Temperature limits for use Ensure that the Nozzl...

Страница 12: ...will cause insulin leakage and device malfunction with loss of warranty Replace the InsuJet in time The same device should never be used for more than 5000 injections Do not use the device past the in...

Страница 13: ...d in violation with this instruction for use Please consult your Diabetes Care Specialist when you change your insulin administration system Make sure to carefully monitor your blood glucose levels be...

Страница 14: ...ion 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 contamin...

Страница 15: ...ons for using the 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...

Страница 16: ...ing 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 Noz...

Страница 17: ...tion 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 furth...

Страница 18: ...e Use a 3mL Adaptor and Cartridge Holder if you want to use insulin from a 3mL cartridge Use a 3mL Adaptor if you want to use insulin from a disposable prefilled pen If you want to use insulin from a...

Страница 19: ...mL cartridge Example of a 10mL Adaptor with a 10mL 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...

Страница 20: ...ke 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 Slide the 3mL cartridge into the Holder with the bo...

Страница 21: ...naps 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 pla...

Страница 22: ...ce the Nr1 and Nr2 arrows on the front of the device Charging the InsuJet 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 de...

Страница 23: ...irection of the 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...

Страница 24: ...er 0 re appears in the Dosage Window The front of the device should be easy to turn at this stage Prime your InsuJet every time you use a new Nozzle or new Adaptor Priming reduces air bubbles inside t...

Страница 25: ...tor 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...

Страница 26: ...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 appears...

Страница 27: ...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...

Страница 28: ...afety 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...

Страница 29: ...start rotating the front in the direction of the 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 ro...

Страница 30: ...0 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 stag...

Страница 31: ...he Nozzle Cap from the Nozzle and the Adaptor Cap from the Adaptor Connecting the Adaptor to the Nozzle Align the Adaptor with the Nozzle and firmly rotate the Adaptor clockwise until the Adaptor snap...

Страница 32: ...32 Tap the insulin cartridge or vial firmly to remove possible air bubbles from the needle opening inside the cartridge or vial...

Страница 33: ...ble air bubbles 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 Dosage Window facing you On the front side of the I...

Страница 34: ...t upright and tap the Nozzle firmly with your fingertips collecting all air bubbles close to the opening To remove possible air bubbles start by disconnecting the Adaptor with the insulin cartridge vi...

Страница 35: ...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 If the drop doesn t appear re connect the Adaptor with the ca...

Страница 36: ...36 4 40 Check if the Nozzle is completely filled with insulin before using the InsuJet Before administration always read the number of units in the dose window to ensure you have set the correct dose...

Страница 37: ...our 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 To administer y...

Страница 38: ...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 rou...

Страница 39: ...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 a...

Страница 40: ...er the administration continue to push the Nozzle firmly against the skin for at least 5 seconds to prevent insulin leakage NOTE In case you experience pinprick bleeding after administration please co...

Страница 41: ...some of your insulin is administered Monitor your blood glucose level closely and contact your diabetes care specialist in case of doubt Sensation It is quite normal to feel a slight sensation during...

Страница 42: ...42 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...

Страница 43: ...e 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 t...

Страница 44: ...e 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 sn...

Страница 45: ...45 Once you have fully inserted the Nozzle turn the Nozzle Lock until the Nozzle Lock Switch points to the locked position...

Страница 46: ...46 additional information...

Страница 47: ...zle until it snaps in place NOTE For hygienic reasons be careful not to touch the Nozzle tip when installing the Comfort Ring Using a Comfort Ring The Comfort Ring is a round plastic disc that can opt...

Страница 48: ...48 Example of a disposable penfill with a 3mL Adaptor Using insulin from a disposable penfill...

Страница 49: ...enfill 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 Nozz...

Страница 50: ...and Adaptors are compatible with one another There are six types available Refer to the packaging label for part identification and REF numbers Nozzle REF 01025 Nozzle REF 01075 3mL Adaptor REF 01035...

Страница 51: ...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 Tilt the Adaptor with the cartridge vial uprigh...

Страница 52: ...2 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 Using a 01055 or 01065 Adaptor with a 01025 Nozzl...

Страница 53: ...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 low fat or high muscle content Abdomen Use the a...

Страница 54: ...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 NOTE For relatively s...

Страница 55: ...er period needs to be carefully monitored and the Diabetes Care Specialist who is involved in your care should be consulted How does the InsuJet administer insulin The back of the InsuJet is rotated t...

Страница 56: ...in the following manners can be loaded into the InsuJet using the appropriate InsuJet Adaptors 3mL cartridge Disposable penfill 10mL Vial Is the InsuJet suitable for use by partially sighted The InsuJ...

Страница 57: ...s Diabetes Care Specialist before switching to the InsuJet In case I use different types of insulin why should I use a separate InsuJet device for each type The same Nozzle should never be used to adm...

Страница 58: ...the InsuJet as well Please consider using a Comfort Ring to reduce the pressure of the Nozzle on your skin If you require a relatively large amount of insulin it may be worth splitting your dose E g...

Страница 59: ...ministration can occur if you administer insulin close to a nerve ending This cannot be foreseen although some people may find that particular areas are more sensitive and should be avoided Note Admin...

Страница 60: ...bout the side effects of insulin injection Infection If you notice signs of an infection at the injection site please consult your doctor Hyperglycemia Hypoglycemia Hyperglycemia or high blood sugar i...

Страница 61: ...e of 90 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 Alwa...

Страница 62: ...heck 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 Only a small section of the Plun...

Страница 63: ...of the cartridge or vial Please note that you can also smell the insulin once the needle fully pierced the septum If the needle is not visible rotate the cartridge inside the Holder The needle will cu...

Страница 64: ...lowing the triangular shapes of the Nozzle into the Nozzle Lock After the Nozzle is completely pushed into the mechanism and the Nozzle Lock is rotated to its closed position the second triangular par...

Страница 65: ...e Dosage Window Follow the steps described in the section PREPARING THE INSUJET FOR ADMINISTRATION to draw insulin into the Nozzle If you experience problems drawing insulin from your cartridge or via...

Страница 66: ...h administration Place the cartridge vial Adaptor Cover back on the cartridge vial Adaptor after drawing insulin into the Nozzle Discard the cartridge vial Adaptor along with each empty insulin cartri...

Страница 67: ...o not store the system in the refrigerator or in a damp area Dampness may affect the device and cause corrosion When you travel by plane or in the event of sudden pressure or temperature changes keep...

Страница 68: ...Oxide A medical device sterilized by ethylene oxide ISO 15223 1 2016 5 2 3 Do not resterilize Do not resterilize Indicates a medical device that is not to be resterilized EN 980 5 22 ISO 15223 1 2016...

Страница 69: ...223 1 2016 5 6 3 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 on...

Страница 70: ...the Use by date that is shown below Replacement guidance Nr of injections per day Replace your InsuJet device 3 or less before the Use by date of the device 4 41 months after first use or before devic...

Страница 71: ......

Страница 72: ...ght European Pharma Group BV 21 June 2018 012000 EN 8 2 Euro Offices Building 3rd Floor Beechavenue 127 1119 RB Schiphol Rijk The Netherlands www insujet com info insujet com Contact details InsuJet d...

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