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 1.2INTENDED USE AND INDICATIONS...2 1.3USING THE INJEX SYSTEM WITH INSULIN...2 2.THE INJEX SYSTEM COMPONENTS...3 2.1 THE INJECTOR...3 2.2THE RESET BOX...3 2.3THE DISPOSABLE AMPULE...3 2.4THE VIAL ADAPTER...4 3.2DRAWING UP MEDICATION...6 3.3TIPS FOR INJECTING WITH INSULIN...9 3.4DRAWING UP A MIXED INSULIN DOSE...9 3.5SELECTING THE INJECTION SITE...12 3.6INJECTION TECHNIQUE...13 4. WARNINGS AND PRECAUTIONS...15 5.INJECTOR MAINTENANCE AND STORAGE...16 6. WARRANTY INFORMATION...17 7.TROUBLE SHOOTING...18/19

1. INTRODUCTION TO THE INJEX T M S Y S T E M W A R N I N G : Please read the instruction man - ual very carefully before using the Injex Needle Free Injector System! Consult your physician prior to your first application. 1.1 PRODUCT DESCRIPTION The Injex Needle Free Injectors are designed to deliver medications and vaccines 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 t i ssue under the skin) for self-injection of those medications or in a clinical setting for use by healthcare professionals. The fear of injections using a needle is very comm o n. This fear of needles may cause people to avoid t r e a t m e n t for serious conditions such as diabetes. The Injex Needle Free Injector System helps p e o p l e overcome the barriers of injections with needles. The advantages of the Injex System are: Virtually painless delivery of medications Safe and easy to use Accurate delivery of medication dose Eliminates risks of needle-stick injuries in the home and clinical setting 1

1.2 INTENDED USE AND INDICATIONS The Injex T M Needle Free Injector System is designed to deliver various medicines and vaccines by means of a fine stream of fluid that penetrates the surface of the skin and delivers the medicine or vaccine to the body. C A U T I O N: Please check the drug manufacturer s information for each medication regarding indicat i o n s and safe handling. C A U T I O N : Please consult with your physician prior to any use. C A U T I O N : Discuss any change in the insulin dosage or delivery system with your physician or healthcare professional before use. C A U T I O N : You should always check your blood sugar levels more frequently when making any change in dose or delivery system to be sure that your control goals are being met. 1.3 USING THE INJEX SYSTEM WITH INSULIN The Injex 30 delivers doses from 0.05 to 0.3 ml or 5 to 30 units of U-100 insulin. The Injex 50 delivers doses from 0.1 ml to 0.5 ml or 10 to 50 units of U-100 insulin. C A U T I O N : The Injex Needle Free Injectors are designed for use with U-100 insulin only. 2

2. THE I N J E X T M SY STE M 2.1 THE INJECTOR The Injex Needle Free Injector is about the size of a pen. The Injector is available in two models: The Injex 30 and the Injex 50. Both Injectors propel a fine stream of medication through a tiny opening at the end of a disposable Ampule and into the subcutaneous tissue of the body. The Injex 30 Needle Free Injector 2.2 THE RESET BOX The Reset Box automatically sets the Injex Needle Free Injector each time the lid of the box is closed. 2.3 THE DISPOSABLE AMPULE The Ampule is like a transparent syringe without a needle and is used to draw a single dose of medication from a medicine vial using a Vial Adapter. The Ampules are marked in both U-100 insulin units and milliliters. The Injex 30 Ampule delivers doses from 0.05 to 0.3 ml or 5 to 30 units of insulin. The Injex 50 A m p u l e delivers doses from 0.1 to 0.5 ml or 10 to 50 units 3

The Injex 30 Ampule of insulin. The Ampule is a single use sterile c o m p o n e n t of the Injex System. Each Ampule is to be used only once and then discarded. C A U T I O N : Repeated use of the Ampule will cause wet shots or Ampule failure and could result in injury to the user. 2.4 THE VIAL ADAPTER The Vial Adapter allows the Ampule to be filled with medication directly from a vial without using a needle. The sterile Vial Adapter fits most medication vials. The Vi a l Adapter has a tethered cap to help keep the vial top and contents clean and secure. 4 2.5 THE STARTER KIT The Injex TM System Starter Kit contains: 1 Injex 30 or Injex 50 Needle Free Injector 1 Compact Reset Box 8 Sterile Injex 30 or Injex 50 Ampules 2 Sterile Vial Adapters 1 Instruction Manual and Training Video 1 Injex Carrying Case Warranty Card with Envelope 1 Vial of Sodium Chloride 0.9% solution (normal saline) to be used for practice injections Sodium Chloride manufacturer s full disclosure insert. (Read prior to your practice injection.) 9 Alcohol Wipes

3. USING THE I N J E X T M S Y S T E M 3.1 PREPARING THE INJECTOR The Injex Starter Kit contains a 2 ml vial of Sodium Chloride 0.9% (saline solution) for practice injections with the Injex System. 3 Pull the lid open until it stops. 4 Place the Injector into the Reset Box so that the open end of the Injector is angled downward and fits over the push rod located toward the hinge of the Reset Box (Fig. 3a). The safety ring (manual safety) should be pushed to the safe position before inserting the Injector into the Reset Box. C A U T I O N : Please read manufacturer s insert prior to practice injection. 1 Place the Reset Box on a flat surface with the hinge facing away from you. 2 Hold the bottom half of the box with one hand and using your other hand, lift the cover of the box by grasping the lip of the top. Figure 3a 5

5 Shut the lid of the Reset Box all the way until it snaps closed. Watch your fingers to avoid pinching. 6 Open the Reset Box and remove the Injector by lifting the rear of the metal body of the Injector (Fig. 3b). The Injector is now set and ready to have the Ampule loaded (Fig. 3c). Safety Ring Trigger Release Figure 3c Injector Body Figure 3b 3.2 DRAWING UP MEDICATION 1 Wash your hands with soap and water. 2 Remove the Vial Adapter (Fig. 3 d ) from the sterile package and remove the protective sleeve from the plastic spike on the Vial Adapter. Tethered Cap Clamps Figure 3d Spike 6

C A U T I O N: The Vial Adapter spike is sharp. Take care when inserting the spike into the vial. Figure 3e 3 Attach the Vial Adapter by placing it on top of the vial at an angle and press down until the spike penetrates the rubber septum on the vial (Fig. 3e). The Vi a l Adapter clamps will hook under the rim of the vial. The Vial Adapter should be left on the vial until it is completely empty and then discarded with the vial. C A U T I O N : The Vial Adapter is designed f o r use with a single vial. Multi-use of the Vial Adapter d o e s not guarantee a sterile condition. T h e r e f o r e, n e v e r use the same adapter on more than one vial! 4 Twist the tethered cap on the Vial Adapter counter c l o c k w i s e and lift off. 5 Remove one Ampule from its sterile package b e i n g careful not to touch the medication delivery end of the ampule. 6 Make sure that the Ampule plunger is pushed all the way forward. Now pull back t h e plunger to the dose level that you will be drawing up. 7 Put the I n j e x Ampule in the open end of the Vial Adapter and turn it c l o c kwise until firmly in place. Vial Adapter Ampule Plunger Figure 3f Vial 7

8 Push the air from the Ampule into the vial while the vial sits upright (Fig. 3f). Now turn the vial upside down and pull back the plunger u n t i l the c o r r e c t amount of medication is drawn into the Ampule. Use the top edge of the outer ring on the Ampule plunger tip as your measurement guide (Fig. 3g). 9 After filling the Ampule, inspect for air bubbles. If bubbles are visible, tap the side of the Ampule Ampule Tip Ampule Figure 3g Plunger Safety Ring Open End of Injector until all bubbles are at the top of the Ampule and then push up to remove air bubbles. Pull plunger down slowly to fill Ampule to the desired dose. 10 Unscrew the Ampule from the Vial Adapter to remove. C A U T I O N : If a larger dosage than intended is drawn from the vial, unscrew the Ampule from the vial and press the Ampule plunger upward in order to remove excess medication. Do not try to put the excess back into the vial. Trigger Release Injector Body Cylinder Safety Ring Rib Cylinder Safety Ring Gap 8 Figure 3h

11 Insert the plunger shaft of the Ampule into the open end of the Injector keeping the Ampule in a straight line to the Injector (Fig. 3h). Open End Safety Ring 13 When you are ready to inject, slide the safety ring on the Injector to the safe off position toward the open end of the Injector. Now the Injector is ready for an injection. 3.3 TIPS FOR INJECTING WITH INSULIN W A R N I N G : Usable insulin compounds the scale of the Injex T M Ampules is currently designed for Figure 3i 12 Twist the Ampule clockwise as far as it will go into the open end of the Injector (Fig. 3i). By twisting the Ampule, the cylinder safety ring rib (automatic safety) moves under the cylinder safety ring gap. The Ampule must be twisted firmly all the way into the Injector or it will not disengage the automatic safety. use with U-100 insulin only. 3.4 DRAWING UP A MIXED INSULIN DOSE C A U T I O N : Mixing compatibility Compounds with different durations of efficacy may be administered through one single Injex Ampule, if they a r e compatible according to manufacturer s standards. 9

1 Wash your hands with soap and water. 2 You must attach a Vial Adapter to each of the vials of insulin that are to be mixed. 3 Remove the Vial Adapters from the sterile packages and remove the protective sleeve from the plastic spike on each of the Vial Adapters. 4 Attach the Vial Adapter by placing it on top of the vial at an angle and press down until the spike penetrates the rubber septum on the vial. The Vial Adapter clamps will hook under the rim of the vial. The Vi a l Adapter should be left on the vial until it is completely empty and then discarded with the vial. 5 Twist the tethered cap on the Vial Adapter c o u n t e r clockwise and lift off of each vial of insulin. 6 Place the two vials of insulin in front of you. 7 Remove one Injex T M Ampule from its sterile package. 8 Make sure the Ampule plunger is pushed all the way forward and then pull back the plunger to the approximate dose level that you will be drawing up from the longer acting i n s u l i n. 9 Put the Ampule in the open end of the Vial Adapter on the longer acting insulin and turn clockwise until f i r m l y in place. 10 Push air into vial. You will only put air in at this time. 11 Remove the Ampule from the longer acting i n s u l i n vial and pull back the plunger to the approximate dose level that you will be drawing up from the r a p i d a c t i n g insulin. 10

12 Put the Ampule in the open end of the Vial Adapter on the rapid acting insulin vial and turn clockwise until firmly in place. 13 Push the air from the Ampule into the vial. Now turn the vial upside down and pull back the plunger until the correct dose of rapid acting i n s u l i n is drawn into the Ampule. Use the top edge of the outer ring on the A m p u l e plunger tip as your measurement guide. 14 After filling the Ampule with the rapid acting d o s e, inspect for bubbles. If bubbles are visible, tap the the side of the Ampule until all bubbles are at the top of the Ampule and then push up to remove air bubbles. Then pull the plunger down slowly to fill Ampule to the desired dose. Unscrew the Ampule from the Vial Adapter to remove. 15 Now, twist the Ampule into the Vial Adapter on the l o n g a c t i n g insulin and draw up the long acting insulin, adding it to the rapid acting insulin already in the Ampule. Add the two numbers of units together to determine the correct total combined insulin dose. Draw back slowly to avoid getting air bubbles. Do not allow the mixed insulin to go back into the long acting insulin vial. 16 Unscrew the Ampule from the Vial Adapter to remove. Holding the Ampule pointing up, tap the side of the Ampule and push any air bubbles out of the Ampule. 17 Insert the plunger shaft of the Ampule into the open end of the Injector keeping the Ampule in a straight 11

line relative to the Injector. 18 Twist the Ampule clockwise as far as it will go into the open end of the Injector (Fig. 3i). By twisting the Ampule, the cylinder safety ring rib (automatic safety) moves under the cylinder safety ring gap. The Ampule must be twisted firmly all the way into the Injector or it will not disengage the automatic safety. Summary: Mixing two insulins 3.5 SELECTING THE INJECTION SITE The I n j e x T M Needle Free Injector may be used in the same injection sites that are appropriate for a subcutaneous injection with a needle and syringe. Site selection for the injection is very important. M o s t injections are administered on the arms, legs, abdomen, hips and buttocks. Select a site that is well developed with subcutaneous fatty tissue and as instructed by your healthcare professional. (Never pinch up the skin.) Step 1: Add air to l o n g e r-acting insulin Step 4: Draw up l o n g e r-acting dose Step 2: Add air to rapid-acting insulin Step 3: Draw up rapid-acting dose Specific recommendations A rm s : Rest your arm on the edge of a table. Relax the muscles and roll the arm forward in order for the fatty tissue to face forward. 12

Place the Injector in the center of the upper arm between the elbow and the shoulder since this area tends to have well-developed fatty tissue. L e g s : Sit straight in a chair with the femur (thigh bone) well supported. Relax the muscles and place the Injector on the side of the upper thigh area, in the center between the knee and the hips. A b d o m e n : For this type of injection you may also sit in a chair and place the Injector on the skin of the abdominal area off to the side (near the abdominal fold). Never place the injection into the center of the abdomen. Hips and Buttocks: You may sit on a chair or stand in a manner that the hips or the buttocks are e a sily accessible. 3.6 INJECTION TECHNIQUE Now that the injection site has been selected, disinfect the injection site with an antiseptic pad or a l c o h o l - s a t u r a t e d cotton ball, or as directed by your healthcare professional. Be sure to let the alcohol dry. 1 With the Ampule loaded with the correct dose of medication in the Injector, slide the safety ring toward the Ampule end of the Injector (safe off position). The Injector is now ready for an injection. 2 Hold the Injector straight up and down, perpendicular to the skin (90 degree angle to the injection site). Push the Injex Ampule tip f i r m l y against the skin, applying enough pressure until the skin is slightly indented and the Ampule leaves a visible impression 13

(foot print) on the skin. 3 When the Injector is in the correct position, push the trigger release and hold the Injector in place until all medication is dispensed from the Ampule (Fig. 3j). Skin Safety Ring Ampule Tip Figure 3j Hold the Injector firmly against the skin, press trigger to inject and continue to hold against the skin for about 2-3 seconds. 4 After pushing the trigger for an injection, continue to hold the injector against the skin for about 2-3 seco n d s. This helps to prevent any reflex reactions caused by the clicking sound of the trigger, which could interrupt the injection process. 5 Upon completion of the injection, lift the Injector, remove and discard the A m p u l e. 6 After the injection, the skin around the site should n o t be stretched or pinched. If a small drop of blood appears, apply a cotton ball or spot bandage to the area. 7 If insulin is visible on the skin in the area of the injection site after injection (wet shot) you should t e s t your blood sugar over the next few hours for high b l o o d sugar and inject additional insulin as required. 14

4. WARNINGS AND PRECAUTIONS Always hold the Injector firmly and in a steady posi - tion during the injection, to prevent skin injuries. After preparing the I n j ex T M Injector for injection, be careful to 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 Ampule into the open end of the Injector. The Injex Injector should be held in a perpendicular p o s ition to the skin (straight up and down to the horizontal skin) and continue to hold 2-3 seconds after injection. Avoid any contact with the tip of the Ampule prior to and after drawing medication into the Ampule to avoid contamination. Check to see that the sterile packaging of the Ampule and Vial Adapter is intact prior to opening. Do not use if packaging is damaged. In the event of loss or malfunction of the Injex Injector, you should always have a back-up injection method available. 15

The scale on the Injex 30 Ampule is marked from 5 to 30 units. The distance between the markings is 0.01 m L or 1 unit. The scale on the Injex 50 Ampule is marked from 10 to 50 units. The distance between the m a r k i n g s is 0.02 ml or 2 units. Injex users may experience faster absorption of insulin compared to n e e d l e i n j e c t i o n s. Carefully test blood or urine sugars b e f o r e using the Injex Injector and for several weeks therea f t e r. Contact your doctor i m m e d i a t e l y i f you feel you need to change your insulin requirements. Keep out of reach of children. 5. INJECTOR MAINTENANCE AND STORAGE Keep the Injector clean, dry and free from dust, dirt and residual medications at all times. Use a damp cloth to clean the outside surface of the Injector, but do not immerse t h e Injector in any fluid. When not in use, store the Injector and system components in the supplied carrying case. Do not store the Injector in the Reset Box. Never fire the Injex Injector with an empty Ampule attached (dry fire). This may damage the Injector. Check Injector regularly for damage. If you suspect the Injector is not working correctly, contact Equidyne Systems immediately at 877-47INJEX (877-474-6539). 16

6. WARRANTY INFORMAT I O N Equidyne Systems, Inc. ( Equidyne ) warrants to you, the end-user customer, that the Injex T M Needle Free Injector and Reset Box will be free from defects in materials and workmanship after the date of purchase, for a period of one (1) year from the date of purchase. If Equidyne receives notice of such defects during the warranty period, Equidyne will, at its discretion, replace products, which prove to be defective. The warranty does not apply to defects resulting from: (a) improper or inadequate maintenance, or (b) improper use of product including but not limited to the firing of the Injector with an unfilled Ampule ( dry firing ). The warranty is null and void if evidence exists upon examination that abuse or dry firing occurred. For additional information regarding the Injex Needle Free Injector System, contact: Equidyne Systems, Inc. 11770 Bernardo Plaza Ct., Suite 351 San Diego, CA 92128 Phone: 858.451.7001 Fax: 858.451.7002 Customer Care: 877.474.6539 Website: www. i n j e x. c o m E-mail: info@equidyne.com 17

7. TROUBLE SHOOTING Injector does not function properly Injector does not fit into the Reset Box Reset Box does not set the Injector Trigger release fails Short shot, not all medication is dispersed C A U S E Injector is not set or Ampule is not secured Safety ring is not in the safe off position Injector not secured Injector or Reset Box very soiled Injector is not in correct position Reset Box defective or not completely closed Device failure Ampule/plunger malfunction or blockage in the tip of the Ampule Possible device failure or broken Injector 18

S O L U T I O N Firmly twist the Ampule into the Injector Slide safety ring to the safe off position Slide safety ring to safe position Clean with a damp cloth Place Injector into the Reset Box with the open end of the Injector angled downward toward the hinge of the Reset Box Close Reset Box completely or contact Equidyne Systems Contact Equidyne Systems Determine the amount of insulin remaining in the Ampule. Using a new Ampule, prepare an additional injection with the amount equivalent to the amount remaining. If second attempt fails, contact Equidyne Systems. Contact Equidyne Systems 19

NOTES

NOTES

Equidyne Systems, Inc. San Diego CA 92128 Customer Care: 877.474.6539 w w w.injex.com 2001 Equidyne INJEX is a trademark of Equidyne Corporation P/N 700735 Rev. C