PRODUCT DESCRIPTION 4 INTENDED USE AND INDICATIONS 4 INJEX COMPONENTS 5 PREPARING THE INJEX SYSTEM 6 PREPARING THE INJECTOR 6 FILLING THE AMPOULE 7

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1 T h e S o f t S h o t Operation instructions INJEX 30

2 T h e S o f t S h o t 2

3 TABLE of contents PRODUCT DESCRIPTION 4 INTENDED USE AND INDICATIONS 4 INJEX COMPONENTS 5 PREPARING THE INJEX SYSTEM 6 PREPARING THE INJECTOR 6 FILLING THE AMPOULE 7 WITH THE TRANSPORTER ADAPTER 7 WITH THE PEN ADAPTER 8 WITH THE VIAL ADAPTER14/22 9 WITH THE LUER ADAPTER 10 PREPARING THE INJECTION 11 PERFORMING THE INJECTION 12 APPLICATION FOR DIABETIC AND OTHER USES 13 APPLICATION FOR DENTAL USE 14 WARNINGS AND PRECAUTIONS 15 CLEANING AND STORAGE 16 WARRANTY 16 SCOPE OF CONTENTS 17 TROUBLESHOOTING 17 TECHNICAL DATA 18 ACCESSORIES 18 SYMBOLS 18 3

4 1. PRODUCT DESCRIPTION 2. INTENDED USE & INDICATIONS The needle-free injection system IN- JEX30 consists of the reusable Injector, Reset Box, Transporter and the sterile Ampoules and Adapters. It is designed to deliver various medications using a comfortable needle-free system for people who take injections, or administer injections to others. The INJEX system may be used with a wide variety of medications that are given subcutaneous (in the fatty tissue under the skin). The needle-free injection system IN- JEX30 is intended exclusively for subcutaneously administering liquid medications suitable for jet injection. The medication is injected by means of a fine stream of fluid that penetrates the surface of the skin and delivers the medication to the body. WARNING: Please read the operation instruction carefully before using the needle-free injection system! Consult your physician prior to your first application. 4 CAUTION: Please adhere strictly to the directions and information for use in regard to indications and safe handling by the manufacturer of each medication concerned. The needle-free system may only be used with pharmaceuticals that are compatible with polycarbonate and silicone.

3. INJEX COMPONENTS Injector: the integrated spring produces the recisely measured pressure for the subcutaneous injection. Reset Box: for resetting of the Injector.

Transporter: for the transfer of medication from pen cartridges (in combination with the Transporter Adapter). Luer Adapter: for the transfer of medication from snap-off ampoules.

Vial Adapter14/22: for the transfer of medication from injection vials with a crimp-diameter of 14mm respectively 22mm.

5 3. INJEX COMPONENTS Injector: the integrated spring produces the recisely measured pressure for the subcutaneous injection. Reset Box: for resetting of the Injector. Ampoules: there are different Ampoules to hold and inject U-100 insulins (5-30 I.U.) or other medications (0,05-0,3 ml). Transporter: for the transfer of medication from pen cartridges (in combination with the Transporter Adapter). Luer Adapter: for the transfer of medication from snap-off ampoules. Adaptateur PEN: conçu pour extraire le médicament à partir de Stylo injecteur vers les ampoules INJEX. Vial Adapter14/22: for the transfer of medication from injection vials with a crimp-diameter of 14mm respectively 22mm. Transporter Adapter: for the transfer of medication from pen cartridges (in combination with the Transporter). CAUTION: The Ampoule is a disposable product to be used only once. Sterility and functionality is not guaranteed for multiple use, so never use the same Ampoule for more than one application! No refurbishment allowed! CAUTION: The Adapter is a disposable product intended to be used only once. Sterility is not guaranteed for multiple use, so never use the same Adapter for more than one medication container! No refurbishment allowed! 5

4. PREPARING THE INJEX SYSTEM 4.1. PREPARING THE INJECTOR 1. Put the Injector into the reset box. Make sure that the green safety ring is in safe position. 2. Close the lid of the Reset Box. 3.

6 4. PREPARING THE INJEX SYSTEM 4.1. PREPARING THE INJECTOR 1. Put the Injector into the reset box. Make sure that the green safety ring is in safe position. 2. Close the lid of the Reset Box. 3. Open the lid of the Reset Box and take out the charged and secured injector. CAUTION: The Adapter needle is sharp. Please exercise extreme care! 6 CAUTION: The Injector can only be placed in the Rest Box and reset once the safety lock has been manually activated!

7 4.2. FILLING THE AMPOULE Filling the Ampoule from pen and cylinder cartridges WITH the Transporter Preparing the Transporter 1. Turn the green knob of the Transporter until the pen or cylinder cartridge can be placed in the Transporter chamber. 2. Take the cartridge and place it in the Transporter chamber. 3. To make sure the cartridge is firmly in place turn the green knob until the Transporter piston is in slight contact with the rubber seal of the cartridge. 4. Take the Transporter Adapter out of its sterile packaging. Screw it fully onto the Transporter. During this process the needle of the Adapter must pierce the rubber seal of the cartridge. Filling the Ampoule 1. Take an ampoule out of its sterile packaging and pull the ampoule plunger about halfway out. 2. Open the lid of the transporter adapter and screw the ampoule as far as it will go into the open end of the adapter. 3. Turn the green knob of the Transporter until the desired dose of medicine is transferred into the Ampoule without air bubbles. Unscrew the Ampoule from the Adapter and reseal with the lid. Tip: Slightly screw back the Transporter knob after the Ampoule is filled, in order to prevent the inner piston of the Transporter from pressing against the rubber seal of the cartridge. This eliminates medication leakage. 7

8 Filling the Ampoule via a pen with the Pen Adapter Preparing the Pen Adapter 1. Take your pen and insert the pen cartridge as usual. 2. Take the Pen Adapter out of its sterile packaging. 3. Screw the closed Pen Adapter onto the thread of your pen. Bleed your pen according to its operating instructions. Filling the Ampoule 1. Take an Ampoule out of its sterile packaging. Tip: For an easy transfer of medication move the Ampoule plunger a little up and down so it is loosens up. After that the plunger must be completely inside the Ampoule. 2. Open the lid of the Pen Adapter and screw the Ampoule as far as it will go into the Adapter. 3. As usual set the required units with the pen. Fill the Ampoule by activating the pen trigger and keep it pressed for a few seconds. Unscrew the Ampoule from the Adapter and reseal with the lid. 8

9 Filling the Ampoule from injection vials with the Vial Adapter14 or Vial Adapter 22 Preparing the Vial Adapter14 or Vial Adapter22 1. Take a medicine vial out of its packaging and remove the protective cap. Filling the Ampoule 2. Take the Vial Adapter out of its sterile packaging. 3. Pierce the rubber stopper of the medicine vial with the needle of the Vial Adapter. Make sure the Vial Adapter is firmly in place. 1. Take an Ampoule out of its sterile packaging and pull the Ampoule plunger about halfway out. 2. Open the lid of the Vial Adapter and screw the Ampoule as far as it will go into the Adapter. 3. Open the lid of the Vial Adapter and screw the Ampoule as far as it will go into the Adapter. 4. Slowly pull out the Ampoule plunger until the desired dose has been drawn out without air bubbles. Unscrew the Ampoule from the Adapter and reseal with the lid. 9

10 Filling the Ampoule from snap-off ampoules WITH the Luer Adapter Preparing the Luer Adapter 1. Take a sterile cannula with a luer lock out of its sterile packaging. Filling the Ampoule 2. Take the Luer Adapter out of its sterile packaging. 3. Connect the sterile cannula with luer lock to the luer cone of the Adapter 1. Take an Ampoule out of its sterile packaging und push the Ampoule plunger all the way into the Ampoule. 2. Open the lid of the Luer Adapter and screw the Ampoule as far as it will go into the Adapter. 3. Remove the protective cap from the sterile cannula and insert the needle with the Luer Adapter into the desired medicine container (e.g. snap-off ampoule). 4. Now slowly pull out the Ampoule plunger until the desired dose has been drawn out without air bubbles. Unscrew the Ampoule from the Adapter and reseal with the lid. CAUTION: If a larger dosage than intended is drawn, unscrew the Ampoule from the Adapter and press the Ampoule plunger upward in order to remove excess medication. Do not try to put the excess back into the medication containment. 10 CAUTION: Avoid all contact with the interior of the Adapter so as to prevent any contamination.

11 5. PREPARING THE INJECTION 1. Unscrew the filled Ampoule from the Adapter and close the lid. 2. Now screw the filled Ampoule as far as it will go into the open end of the Injector. NOTE: As the screw tightens, the first safety mechanism will be deactivated. 3. Push the green safety ring forward into the safe off position. Now the second safety mechanism is deactivated and the Injector is ready for use. 11

12 6. PERFORMING THE INJECTION 6.1. APPLICATION FOR DIABETIC AND OTHER USES The INJEX Injector may be used on the normal areas of the body suitable for subcutaneous injection. In most cases, injections are adminstered to the arms, legs, abdomen, hips and buttocks. Site selection of the injection is very important. Select a site that is well developed with subcutaneous fatty tissue and as instructed by your healthcare professional (never pinch up your skin). 1. Press the Injector perpendicular onto the injection site (at a 90 angle), until the skin is clearly dented and the ampoule tip is completely enclosed by the skin. 2. Activate the trigger and keep the Injector firmly in place for two seconds after the injection. 3. Unscrew the Ampoule from the Injector. The used Ampoules are disposable as normal domestic waste. Push the green safety ring back into the safe position. 12 Store the secured and non-reseted Injector and its accessories in the INJEX Bag. Note that a storage of a reseted Injector in the Reset Box can cause functional damages of the Injector.

13 Recommendations for site selection: Abdomen: Stand upright and place the Injector on the skin to the side of your abdomen (at the height of your stomach fold) Never inject into the center of your abdomen. Arms: Rest your arm on the edge of a table. Relax your muscles and roll the arm forwards to raise the fatty tissue. Apply the injection midway between ellbow and shoulder in the back part of your upper arm as the fatty tissue is particularly pronounced there. Hips and buttocks: Sit on a chair in such a way that your hip or buttock is easily accessible. Legs: Sit back in a chair and allow the chair to support the thigh. Relax your muscles and apply the injection to the upper side area of your thigh, midway between your knee and hip. Specific recommendation for diabetes: To mix two insulins with differing times of action you are required to draw up the required doses consecutively. If air bubbles are visible after drawing up the first type of insulin, tap the side of the Ampoule until all bubbles are at the top of the Ampoule and then push up to remove air bubbles before draing up the second type of insulin. CAUTION: Do not change the order of the insulins to be mixed as stipilated by your physician, or change the type of application or model of the injector without having first consulted your physician. Not complying with this warning can lead to dosage errors! 13

6.2. APPLICATION POUR USAGE DENTAIRE INJEX30 is appointed to be used for the infiltration anaesthesia of selected teeth in the permanent dentition (from 15 to 25 rsp.

14 6.2. APPLICATION POUR USAGE DENTAIRE INJEX30 is appointed to be used for the infiltration anaesthesia of selected teeth in the permanent dentition (from 15 to 25 rsp. from 33 to 43) as well as for all milk teeth. After preparing the injection, consult section 4. to 5. and proceed as follows: 1. Remove the paper seal of the blister package of one SiliTop. Push the Ampoule tip completely into the SiliTop. Now withdraw the Injector with the SiliTop attached to the Ampoule tip out of package. 2. Push the green safety ring forward into the safe off position. Now the second safety mechanism is deactivated and the Injector is ready for use. 3. Hold the Injector between thumb and index finger. The trigger should be released with the thumb. 4. Place the Injector perpendicular (90 ) onto the tight gingiva of the tooth to be medicated. Activate the trigger and keep the Injector firmly on the muscosa for two seconds after the injection. 5. Unscrew the Ampoule from the injector. The used Ampoules are disposable as normal domestic waste. Push the green safety ring back into the safe position. Store the secured and non-reseted Injector and its accessories in the INJEX Bag. Note that a storage of a reseted Injector in the Reset Box can cause functional damages of the Injector. CAUTION: Lean the Injector on the injection site and tell the patient about a comming triggering sound to avoid reflex reactions caused by this which could interfere with the injection process. 14 CAUTION: Please consider general contraindication for local anaesthesia. One should not inject with INJEX over nerval exits (i.e. N. mentalis). Please follow the same general guidelines when injection in inflamed gingiva/ tissue is considered necessary (i.e. antibiotic prophylaxis).

15 7. WARNINGS AND PRECAUTIONS CAUTION: After preparing the Injector for injection do not point the Injector at yourself or other persons (especially the eyes and other sensitive body parts). Accidental release may cause injuries! Do not place anything other than the Ampoule into the open end of the Injector. Check to see that the sterile packaging of the Ampoule respectively the Adapter is intact prior opening. Do not use if packaging is damaged. Fill the medication into the Ampoule without air bubbles. Avoid any contact with the Ampoule tip before and after filling it with medication to avoid contamination. The Adapter needle is sharp. Take care not to injure. Always hold the Injector perpendicular (90 ) on the injection site and press it firmly on the surface before activating the trigger. During injection, always hold the Injector firmly in position as injuries can otherwise occur. Do not crease the skin! After injection, never wipe the injection site with alcohol. Although it is not necessary, you can blot the injection site gently with a clean cotton-wool ball if you so wish. Do not use the Ampoule twice because of the possibility of contamination of a used Ampoule and to avoid any loss of function. In the event of loss or malfuction of the INJEX, you should always have a back-up injection method available. 15

16 8. CLEANING AND STORAGE It is important that you keep your INJEX Injector clean and free from dust and medication residues. Clean the outside of the Injector with an alcohol cloth. The Transporter may be cleaned by rinsing it with (warm) water. If soiled (e.g. sticky threads due to medication residues) soak the Transporter in water. For maintaining function, please make sure that all liquid has been removed after cleaning. The INJEX30 System and its accessories should be stored beween +5 C and +35 C, as malfunctions could otherwise occur. Store the secured and nonreseted Injector and its accessories in the INJEX Bag. Note that a storage of a reseted Injector in the Reset Box can cause functional damages of the Injector and shorten its durability. CAUTION: The Injector and its acessories must not be sterilized. Avoid getting any water or cleaning liquidy inside the Injector. CAUTION: Do not use the Ampoule and Adapter after the expiry date (see packaging). CAUTION: Keep out of reach of untrained children. Assure that children using the device are familiar with the injection technique. 9. WARRANTY The INJEX30 System has been produced with the upmost care and has been delivered in perfect technical condition. The warranty period after the date of purchase for the proper working order of the INJEX System is according to the legal regulations. Should, contrary to expectations and despite careful handling of the INJEX30 System, any material or production-related defect occur during the warranty period, we will, at our own discretion, replace products, which prove to be defective. In the event of a claim please provide the defective product together with your purchase receipt, your complete contact data and the address of the source of supply. 16 Your claim please address to: INJEX Pharma GmbH Buckower Damm Berlin Germany info@injex.de Please note that we do not assume any liability for damage which can be ascribed to improper handling of the INJEX30 System and its accessories.

17 10. TROUBLESHOOTING Problem Cause Solution Injector does not activate Injector does not fit into Injector the Reset Box Medication not released Reset Box does not set the Injector Ampoule not seated firmly No Ampoule screwed on Safety Ring not in safe off position Injector not secured Injector or Rest Box very soiled Injector in wrong position Ampoule opening blocked Injector or Reset Box very soild Reset Box not completely closed Possible broken Injector Screw the Ampoule firmly onto the Injector Screw Ampoule on Slide Safety Ring to the safe off position Slide Safety Ring to the safe position Clean with damp cloth Place Injector into the Reset Box with the open end of the Injector angled downward toward the hinge of the Reset Box Use new Ampoule Clean with damp cloth Close reset Box tight Contact the manufacturer 11. SCOPE OF CONTENTS INJEX30 System REF INJEX Injector - Reset Box - Transporter - Storage Bag - Instruction For Use 17

12. ACCESSOIRES - INJEX Ampoule U-100 50 per box REF 546 000 400 - INJEX Ampoule 0.

Adapter22 20 per box REF 511 000 800 - INJEX Luer Adapter 20 per box REF 511 000 600 - INJEX SiliTop 50 per box REF 516 000 000 - INJEX Transporter 1 pcs REF 338 012 000 13.

18 12. ACCESSOIRES - INJEX Ampoule U per box REF INJEX Ampoule 0.3ml 50 per box REF INJEX Transporter Adapter 20 per box REF INJEX Pen Adapter 20 per box REF INJEX Vial Adapter14 20 per box REF INJEX Vial Adapter22 20 per box REF INJEX Luer Adapter 20 per box REF INJEX SiliTop 50 per box REF INJEX Transporter 1 pcs REF TECHNICAL DATA The INJEX30 System is designed to apply dosages from 0.05ml to 0.3ml (Ampoule 0.3ml) respectively 5 I.U. to 30 I.U. Insulin U-100 (Ampoule U-100). The dose accuracy is +/- 2% for dosages < 0.15ml respectively < 15 I.U. Insulin U-100 and +/- 1.5% for dosages > 0.15ml respectively > 15 I.U. Insulin U-100. One scale marking is equivalent to 0.01 ml (Ampoule 0.3ml) respectively 1 I.U. Insulin U-100 (Ampoule U-100). Lifetime of injector is at least injections. 14. SYMBOLES Caution, consult accompanying documents. Do not re-use. Do not use if package is damaged. Sterilized using irradiation Federal US law restrict this device to sale by or on the order of a (licensed healthcare practitioner). Batch identification. Temperature limitation. Serial number Use by. Catalogue number 18

19 NOTES: 19

20 T h e S o f t S h o t GMBH Buckower Damm Berlin Germany info@injex.de

I n s t r u c t i o n M a n u a l

I n s t r u c t i o n M a n u a l TABLE OF CONTENTS 2.5THE STARTER KIT...4 3.USING THE INJEX SYSTEM...5 3.1 PREPARING THE INJECTOR...5 1. INTRODUCTION TO THE INJEX TM SYSTEM...1 1.1PRODUCT DESCRIPTION...1