Instructions for Patient Use - V-Go
Contents
1. 0 0 c cee eee eee 36 75 en ARR 36 V GO leeeseeeee RR RRRRRRRRRRRR RR RR RR R3 e e uas 37 Delivery accuracy test results 0 0 0 0 cee eee 38 Section 5 V Go User Assistance Information 40 Section 6 Troubleshooting Frequently Asked Questions 41 Section 7 Glossary and Packaging Symbols 48 SECTION 1 Part 1 INTRODUCTION AND V Go OVERVIEW The V Go provides a continuous subcutaneous insulin infusion over 24 hours It uses a preset basal rate for between meal and nighttime insulin The V Go provides on demand bolus dosing to cover glucose intake at meals The V Go device is convenient and easy to operate see Section 3 for indication Here is how to use the V Go e Fill the V Go with insulin using the EZ Fill Attach the V Go to a selected site skin area Push in the needle button to deliver the preset basal rate Wear the V Go for one 1 24 hour period Bolus dose at meals as prescribed by your doctor or healthcare professional At the end of the 24 hour period retract the needle and remove the V Go from your body e Discard the device after use the V Go is 100 disposable e Repeat these steps for the next 24 hour period using a new V Go Healthcare Professional Prescribing Considerations Dosing considerations e When selecting a V Go option healthcare professionals should refer to their own experience when initiating continuous sub2. Fast acting glucose tablets Blood glucose and urine ketone monitoring supplies Back up insulin insulin syringe and needles with directions from your doctor or healthcare professional regarding how much insulin to take Dressing and adhesive 32 You should avoid exposing the V Go to direct sunlight You should avoid exposure to extremely hot temperatures Remove the V Go prior to hot tub whirlpool or sauna use and replace with a new filled V Go afterward You should check that the V Go is securely in place during and after periods of increased physical activity Check that the V Go is securely in place if it has been exposed to water or gone under water to the depth of 3 feet 3 inches 1 meter The V Go can go under water and will continue to work safely You should follow these precautions to help prevent problems with the V Go placement 1 Never use insulin that appears cloudy Cloudy insulin may be inactive Do not use cloudy insulin with the V Go 2 Do not expose the insulin to extreme changes in temperature Check the insulin package insert for temperature variation 3 Practice aseptic technique when preparing filling and attaching the V Go 4 Check the adhesive site for redness irritation and inflammation when you remove a used V Go and before you attach a new V Go 5 Change the application site each time you change the V Go See Section 2 Part 3 Step 3 Changing the site will ensure proper abs
3. You should remove the V Go before having an X ray MRI or CT scan or any similar test or procedure Replace with a new V Go after the test or procedure is completed You should monitor your blood glucose levels based on your doctor s or healthcare professional s recommendation American Diabetes Association guidelines suggest that patients test blood glucose 3 or more times daily You should act quickly to respond to abnormal blood sugar levels e Notify your doctor or healthcare professional of any serious hypoglycemia or hyperglycemia Tell your doctor or healthcare professional of any increased frequency in abnormally high or low blood glucose test results You should create a plan with your doctor or healthcare professional in case a problem occurs when you are unable to reach him or her for advice You should create a plan with your doctor or healthcare professional on how to manage your bolus mealtime dosing using the V Go including what to do if you lose count while bolus dosing or if you forget to take a bolus dose You should carry an emergency kit of insulin supplies if instructed by your doctor or healthcare professional in case you develop a problem with the V Go that stops your insulin delivery Tell a family member or friend where you keep your emergency kit items e You should speak with your doctor or healthcare professional regarding what to have in the emergency kit which often includes the following items
4. IMPORTANT If the bolus ready button or bolus delivery button does not press in or does not click when pressed you may have used all of the available bolus doses If you require additional bolus doses do not continue to use this V Go M Replace it with a new filled V Go Step 7 Monitor V Go progress A While wearing the V Go you should check your blood glucose at regular intervals to make sure the V Go is working properly Refer to Section 3 for recommendations on blood glucose monitoring B You can also check the movement of the grey indicator in the viewing window to make sure the V Go is working properly After several hours you should see a slight change in the location of the grey indicator as it moves toward the needle button e he exact location of the grey indicator will vary based on the number of bolus doses you have used Grey Indicator 26 IMPORTANT The indicator moves very slowly over the 24 hour period It will take time to notice the change in the indicator location Monitoring the V Go progress is important to make sure the V Go is delivering insulin If the indicator does not appear to be moving after several hours of wearing the V Go consider checking your blood glucose levels If your levels are abnormally high after normal V Go use as prescribed by your doctor or healthcare professional you should remove the V Go and replace it with a new one Step 8 Remove the V Go IMPORTANT After 24 hou
5. plug back into the EZ Fill B Store the EZ Fill with the insulin vial and plug attached in a clean dry area of the refrigerator between each fill Store unfilled unused V Go devices in a dry safe place until your next fill Please refer to Section 4 for additional storage information Additional Steps Step 7 Remove an empty vial of insulin from the insulin vial holder and place a new vial of insulin into the insulin vial holder NOTE Before placing a new vial into the EZ Fill check to make sure the insulin vial is not expired and that it will not expire during the time period that the vial will be used in the EZ Fill A Grasp the vial along the finger and thumb grooves Pull up the vial to remove it from the EZ Fill B To place a new vial of insulin into the EZ Fill L follow filling Step 3A to 3E 2 Step 8 Dispose of the EZ Fill A After the 30 fill use period discard the EZ Fill with the insulin vial attached according to local disposal requirements The insulin vial should be discarded a even if there is insulin remaining in the vial IMPORTANT The EZ Fill is only intended to fill a 30 day supply of V Go devices 1 V Go per day A new EZ Fill will be provided with each monthly prescription of the V Go Do not use the same EZ Fill for more than 30 fills SECTION 2 Part 3 APPLYING AND USING THE V Go Step 1 Inspect the V Go before you attach it to your body zm A Lo
6. 1 67 U hr Bolus Delivery On Demand Each push of the bolus delivery button provides 2 Units storage Conditions 4 F 20 C to 140 F 60 C Each V Go contains 18 uses for a maximum of 36 Units per V Go Unused Device Only 20 to 90 relative humidity V Go Minimum Capacity Reservoir 0 56 mL V Go 20 Operating Conditions 40 F 5 C to 99 F 37 C 0 66 mL V Go 30 20 to 90 relative humidity 0 76 mL V Go 40 Warm to room temperature to optimize fill quality 24x1 3x0 5 ne Each time before placing a new vial into the EZ Fill check 6 1 cm x 3 3 cm x 1 3 cm to make sure the insulin vial is not expired and that it will V Go Weight 0 7 to 1 8 ounces not expire during the time period that the vial will be used 20 to 50 grams Storage Conditions 10 F 12 C to 140 F 60 C Device Only 200 to relative nidi in the EZ Fill Duration of Use 30 fills Avoid prolonged exposure to the extremes of the storage temperature range Storage Conditions The V Go may be filled with Humalog for up to 24 hours prior to Filled with Humalog use if refrigerated or if left at room temperature Storage Conditions The V Go may be filled with NovoLog for up to 5 days prior Filled with NovoLog to use if refrigerated The V Go may be filled with NovoLog for up to 3 days prior to use if left at room temperature Operating Conditions 40 F 5 C to 99 F 37 C 20 to 90 relative humidity Do not expose the V Go to tempera
7. in carbohydrates Glucose is the body s most important source of energy It is produced from digested food by the normal action of the liver Glucose is carried by the blood throughout the body Hyperglycemia Hyperglycemia or high blood sugar occurs when blood glucose levels rise above normal approximately 250 mg dL Hyperglycemia is the result of the body not having enough insulin or not being able to use insulin to process glucose Hypoglycemia Hypoglycemia or low blood sugar occurs when blood glucose levels drop below normal approximately 70 mg dL Hypoglycemia may result from too much insulin and or exercising more than usual Infusion site The infusion site is the place on the body where the V Go is attached specifically the end of the V Go where the needle is inserted under the skin Insulin Insulin is a hormone produced by the pancreas Insulin is needed by the body to regulate the production and use of glucose Ketones Ketones or ketone bodies are substances produced by normal liver activity and used by muscle tissue When blood glucose levels are elevated the body s normal process is unbalanced and ketones can accumulate in the blood pass through the urine and ultimately result in diabetic ketoacidosis DKA Subcutaneous Subcutaneous means beneath the layer of the skin The V Go infusion needle delivers insulin subcutaneously Subcutaneous injections are not the same thing as intravenous IV or intramuscular IM i
8. initially prescribing the V Go e Understand the total daily dose of insulin your patient is actually taking with their current insulin regimen versus what is being prescribed Selecting the correct V Go option may lessen the risk of hypoglycemia e tis common practice to reduce the total daily insulin dose when starting a patient on continuous subcutaneous insulin infusion therapy and this reduction should be considered when starting a patient on the V Go Warnings Insulin requirements If you have to make regular adjustments or modifications to your basal rate during a 24 hour period or if the amount of insulin used at meals requires adjustments of less than 2 Unit increments use of the V Go may result in hypoglycemia The following conditions may occur during insulin therapy with the V Go e Hypoglycemia Intensive management of diabetes with too much insulin has been associated with an increase in the incidence of hypoglycemia low blood sugar e Hyperglycemia and diabetic ketoacidosis DKA Any insulin delivery interruption may result in hyperglycemia high blood sugar or the onset of diabetic ketoacidosis If you have a medical emergency while using the V Go call 911 your doctor or go directly to the hospital 31 Precautions General The following are a number of general precautions you should consider when using the V Go Disposable Insulin Delivery Device The V Go is magnetic resonance MR unsafe
9. inner package for the V Go is torn or damaged If you suspect the package containing the V Go has been torn or damaged do not use this V Go Replace with a new V Go After removed the button cover the cover pin was not attached to the button cover and is still inside the V Go If the cover pin is inside the V Go the V Go will not work correctly Try to remove the pin manually otherwise discard this V Go and start over with a new V Go It is difficult to press down on the needle button Be sure you are pressing the raised bump of the needle button If the needle button does not move when pressed the needle button may have already been activated Do not use this V Go Replace with a new V Go The needle button will not stay in the down position The needle button must be pressed down fully to be locked into place If you cannot get the button to stay down do not use this V Go Replace with a new V Go The V Go won t remain securely attached to my skin for the duration of use which sometimes causes poking of the needle If the V Go will not remain secure replace with a new V Go When replacing the V Go please review Section 2 Part 3 Step 3A to 3D Do not touch the adhesive pad before you attach the V Go to your skin Thoroughly clean the site with an alcohol swab Let the site dry before attaching the V Go Many lotions and ointments may keep the V Go from sticking to your skin Be sure that you have properly attached the V Go to
10. of the following positions sitting down standing up or lying down C When choosing the location for the V Go avoid the following e he belt line or waistline or other areas where clothing may rub or constrict e Areas with excessive hair You may shave the area to help the V Go attach to your skin 2 e Areas that are curved or rigid due to muscle i di or bone e Areas within a 1 inch circle around the belly e Skin that is tender bruised red or hard or has any skin disease or infection button or surgical scars NOTE If you have sensitive skin or your skin becomes irritated ask your doctor or healthcare professional about skin barrier products NOTE Change the location of the V Go slightly every 24 hours Needle insertion sites should be at least 1 inch away from the last site This may mean moving it from the right to the left side of the abdomen It does not require attaching the V Go on the abdomen one day then on the arm the next 20 D Clean the area where you will attach the V Go with an alcohol swab e he alcohol swab will remove all lotions and oils Let the area dry This helps the adhesive stick properly to the skin e Practice aseptic technique as described in Section 2 Part 1 Zn Step 4 Attach the V Go Actions in this step describe how to attach the V Go to your abdomen As noted in section 2 Part 3 Step 3 there are a couple of places you can attach the V Go A Practice
11. placing the V Go before you actually remove the protective liner Practice helps you to make sure you can reach and operate the bolus ready button bolus delivery button needle button and needle release button e o practice with your right hand hold your thumb on the needle release button your index finger near but not on the bolus delivery button and middle finger near the bolus ready button e Hold the V Go on the selected body site to make sure that you can reach all necessary buttons when you wear the V Go Now you are ready to attach the V Go IMPORTANT Be careful not to press any buttons when you practice attaching the V Go 21 B Remove the button cover 1 Hold the V Go with one hand and pull the y button cover with the other hand Pull the button t O EP cover in a quick straight direction up and away ED from the V Go ia at 2 Check to see if the cover pin came off with the t 7 button cover lt a 5 e f the cover pin is not attached and has pu z remained inside the V Go try to remove the pp pin manually otherwise discard this Oy V Go and start over with a new V Go IMPORTANT If you bend the button cover j backwards as you would a soda pop can top Wy SF you could damage the V Go C Lift the adhesive tab and completely peel off the adhesive liner from the bottom of the V Go Removing the liner exposes the adhesive 1 Do not touch the adhesive surface Touching the adhesive sur
12. sees 16 otep 7 Remove an empty vial of insulin from the insulin vial holder and place a new vial of insulin into the insulin vial holder 16 Step 8 Dispose of the EZ Fill lsssee RR IIwe 17 The V Go Disposable Insulin Delivery Device should be used only by people who have been prescribed the device and only for intended use Terms in bold and italic are explained in the glossary Section 2 Part 3 Applying and Using the V Go 18 step 1 Inspect the V Go before you attach it to your body 18 step 2 Wash your hands sssessee RR RII 19 step 3 Select and prepare the infusion site 0 0 00 19 Step 4 Attach theV G0 lsssses RR 21 Step 5 Start the 24 hour flow of insulin with the V Go 00 23 step 6 Bolus dose with the V Go at mealtimes 0000 24 Step 7 Monitor V Go progress ssssen n n RR IR 26 Step 8 Remove theV G0 0 cc RR RR 27 Step 9 Dispose of the V GO 0 ce eee eens 29 Section 3 V Go Safety Information 0 0 0 0 cee eee 30 Oena s4 9u ae he eeewee beeen dee sedans Geen nads 14 aoe E EE E 30 Indication 0 0 eee eee eee 30 Healthcare professional dosing considerations 00 31 WaN See o24 54 acakmn den dead m dor do yew dene EE OR es eats 31 gdiztdl p T E E EE 32 Adverse reactions llle RII IR 39 Section 4 Product Specifications
13. 9 If you have a medical emergency while using the V Go call 911 your doctor or go IMPORTANT Understanding the button names and locations Is Important for the successful use of the V Go and EZ Fill directly to the hospital Vr V Go Product Overview Liability Disclaimer Button Cover Covers the needle button Valeritas does not give medical advice about insulin therapy Discuss all medical EE su Prevents the needle button from being pushed therapies with your healthcare professional in Cover must be removed for V Go to operate e Insulin Port Location where insulin enters the V Go through the EZ Fill e Bolus Ready Button A grey button that lies flat on one of the long edges of the V Go When activated it releases the bolus delivery button This allows for bolus dosing of insulin e Bolus Delivery Button A grey button next to the insulin port on one of the short edges of the V Go When pressed after the bolus ready button activates this button the V Go delivers a bolus dose of 2 Units of insulin 1 push 2 Units e Viewing Window Shows a view of the insulin reservoir A grey indicator in the window demonstrates that insulin is flowing from the device SECTION 1 Part 2 BEFORE YOU BEGIN Step 1 Remove the EZ Fill from the blister packaging A Turn the packaging over so you can read the text dd B Peel back on the lower right corner um C Remove the EZ Fill Viewing Window Grey Indicator mu w
14. DISPOSABLE INSULIN DELIVERY Customer Care 1 866 881 1209 Using the V Go Disposable Insulin Delivery Device Instructions for Patient Use Training on the V Go is important If you have not been previously trained speak to a Valeritas Customer Care Representative at 1 866 881 1209 before using the V Go Read the entire manual before operating the V Go Disposable Insulin Delivery Device CONTENTS Section 1 Part 1 Introduction and V Go Overview 4 Healthcare professional prescribing considerations 4 Valeritas customer Care ete ee ees 6 Liability disclaimer seen eee eee 6 Section 1 Part 2 Before You Begin 0 0 c cee 6 Section 2 Part 1 V Go Operating Instructions 7 V Go product overview 0 RR RRIRRRRRRR RI 7 EZ Fill product overview llle RR RnB 8 Aseptic technique 0 0 0 cc eee 9 Section 2 Part 2 Filling the V Go with Insulin Using the EZ Fill 10 Step 1 Remove the plug from the EZ Fill drawer 0 000 10 Step 2 Place the V Go into the EZ Fill 0 0 cc eee 11 Step 3 Place the insulin vial into the EZ Fill insulin vial holder 12 Step 4 Fill the V Go with insulin ll 13 Step 5 Remove the V Go from the EZ Fill 0 0 ce ee 15 otep 6 Store the EZ Fill and unfilled V Go devices after each day s V Go filling session
15. a flat surface on your body If the site is covered with hair this could also affect whether the V Go sticks You may shave the area to help the V Go attach to your skin 44 When I went to give myself a bolus dose of insulin the bolus delivery button was already popped out If the bolus delivery button was already popped out the bolus ready button was already activated Press the bolus delivery button to deliver 2 Units of insulin when the next bolus dose is needed The bolus delivery button will not pop out First check that you are pressing the bolus ready button fully If the bolus delivery button fails to pop out after you activate the bolus ready button you have used all of the available insulin for bolus dosing 36 Units or 18 uses per 24 hours Replace this V Go with a new V Go before your next meal Plan your day so that you have enough insulin for each meal What should do if forget the number of Units have delivered when bolus dosing or if forget to take a bolus dose Follow the plan you created with your doctor or healthcare professional for such situations If you have not created a plan already consult your doctor or healthcare professional for guidance The area of skin around the V Go is red and sore to the touch okin may be irritated by the adhesive pad on the V Go There are a number of skin barrier products available to help prevent irritation and treat sensitivity problems Contact your doctor or hea
16. ak to a Valeritas Customer Care Representative 24 7 at 1 866 881 1209 Customers can visit the Valeritas website www valeritas com for additional information about disposable insulin delivery with the V Go If you have a medical emergency while using the V Go call 911 your doctor or go directly to the hospital 40 How do know how much insulin to put into the V Go You always fill the V Go completely The V Go comes in 3 options and your doctor or healthcare professional will select the option you need Why does insulin leak from the EZ Fill Check to make sure a V Go is placed in the EZ Fill before a new insulin vial is placed into the insulin vial holder This may reduce any insulin leak that can happen when extra pressure is built up in the vial upon initial puncture Also make sure the plug is properly inserted into the EZ Fill between fills It looks like the V Go has not filled completely There are 5 reasons the V Go may not fill completely 1 The insulin vial is not completely pushed down into the insulin vial holder e fthis is the case push the vial firmly straight down into the insulin vial holder until you feel it attach and cannot push it further 2 You have run out of insulin in your vial You have to switch vials before you can fill the rest of the V Go e fthis is the case keep the V Go in the EZ Fill drawer Remove the insulin vial from the EZ Fill insulin vial holder replace with a new vial and refil
17. allim mim inam mem P in mmh ey o ri Step 2 Remove the V Go from the blister packaging A Turn the packaging over so you can read the text e Needle Button When pressed it inserts the B Peel back on the lower left corner on one of the 7 7 needle into your skin and begins the flow of V Go containers A f Needle insulin into your body C Remove the V Go Do not pull on the adhesive tab p th T Needle Release Button A wide white button while removing the V Go from the container with 3 ridges on one of the long edges of the V Go An activated needle release button removes the needle from your body and stops the V Go from delivering insulin e Adhesive Pad and Liner Once the protective adhesive liner is removed the adhesive pad affixes the V Go to your skin NOTE Only remove one 1 V Go every 24 hours to fill apply and use Leave the rest in their containers until you are ready to use them Adhesive Pad and Liner Needle Release Button Ribbed Drawer Handle jf EZ Fill Product Overview Finger Groove ESEM yy Insulin Supply Window wa Insulin Vial Holder Co ames Grip E f EN d Drawer N d 2 Sy Cap mc EZ Fill Bottom Cap Protects the needle inside the EZ Fill bottom of insulin vial holder Finger Groove Opening to allow for easy removal of the insulin vial Insulin Vial Holder Opening in the EZ Fill where the insulin vial is placed upside down Insulin Supply Wi
18. ation that remains flat when you are sitting down standing up or lying down Discuss the best location for you with your doctor or healthcare professional A The V Go can be worn any place that insulin can be injected or infused Insulin is injected or infused into the subcutaneous tissue e You may wish to attach the V Go On the abdomen The abdomen has ample flat surface area and is an accessible and comfortable location Insulin absorption E is fast predictable and less affected by V N eomm I exercise when administered through p the abdomen o If the V Go is worn on the abdomen keep it horizontal above the belt line On the backside of the arm not on the muscle o f the V Go is worn on the backside of the arm keep it in the up and down direction Make sure you can see the grey indicator mE 1 1 in the viewing window directly by rotating your arm or indirectly through the use of a mirror Attach the V Go in the up and down position as your arm hangs down c B When choosing the location for the V Go M consider the following e Make sure you are able to view the grey indicator in the viewing window either directly or indirectly through the use of a mirror e hat you can comfortably reach the V Go and all of the buttons for easy operation and removal e hat you apply the V Go to a flat area of skin not on a fold of the skin muscle or bone e hatthe site is flat when you are in any
19. ces downward a D Place the insulin vial into the EZ Fill Push the vial firmly straight down into the insulin vial holder until you feel it attach and you cannot oush it further LAL E Check the insulin supply window to make sure E there is enough insulin to fill the V Go mm D Slowly and steadily push the plunger down over pereunte a minimum of 25 seconds to fill the V GoTM with insulin e he V Go should be filled with insulin in a continuous flow of droplets not in a solid steady stream Make sure you don t fill the V Go with a steady stream of insulin If you push too fast or too hard the insulin will become foamy Foamy insulin may lead to an incomplete fill If the insulin turns foamy push the plunger more slowly IMPORTANT Watch the insulin fill the V Go to make sure you get a complete fill E Push the plunger until it is all the way down e When the position of the plunger is all the way down the V Go should be full IMPORTANT Make sure the V Go fills with insulin in a continuous flow of droplets not in a solid steady stream Make sure the insulin is not foamy Foam will not damage the V Go or the insulin but may lead to an incomplete fill of the V Go Count to about 25 seconds when you push the plunger down to make sure the V Go is filled with insulin F Check that the V Go is filled properly Ideally you should see only fluid and no air space You may see tiny air bubble
20. cutaneous insulin infusion therapy with a patient If unfamiliar the healthcare professional should refer to insulin therapy guidelines from diabetes associations e he following should be considered when initially prescribing the V Go Understand the total daily dose of insulin your patient is actually taking with their current insulin regimen versus what is being prescribed Selecting the correct V Go option may lessen the risk of hypoglycemia low blood sugar tis common practice to reduce the total daily insulin dose when starting a patient on continuous subcutaneous insulin infusion therapy and this reduction should be considered when starting a patient on the V Go Other prescribing considerations e Aseparate prescription of a U100 fast acting insulin is required for use with the V Go see Section 3 for insulins tested with the V Go Two 2 vials of insulin are required for the V Go 20 option Three 3 vials of insulin are required for the V Go 30 and 40 options The V Go comes in 3 options for your insulin needs Your doctor or healthcare professional has selected the most appropriate V Go option for you The 3 V Go options are GO DISPOSABLE INSULIN DELIVERY 20 Units 24 hr 0 83 U hr basal rate and up to 36 Units of on demand bolus dosing in 2 Unit increments GO DISPOSABLE INSULIN DELIVERY 30 Units 24 hr 1 25 U hr basal rate and up to 36 Units of on demand bolus dosing in 2 Unit incre
21. e ribbed drawer handle and push the drawer completely into the EZ Fill The ribbed drawer handle should not stick out past the bottom of the EZ Fill If there is insulin in the vial and the drawer is completely shut try to fill a new V Go If you are unable to fill a new V Go speak to a Valeritas Customer Care Representative at 1 866 881 1209 There are bubbles in the insulin vial The most common reason for bubbles in the insulin vial is filling more than 1 V Go at a time The EZ Fill is designed to fill only 1 V Go per day It is harder to push the plunger when it gets closer to the downward position This is normal When the V Go is full or close to full you should expect to push a little harder You may need a little extra pressure to push the plunger completely down 42 What happens if do not pull the plunger completely up when fill the V Go If the plunger is pulled only part of the way up during the fill process you will get only a partial fill of the V Go You will see air bubbles in the V Go viewing window Keep the V Go in the EZ Fill drawer and slowly pull the plunger up completely again Make sure the plunger is completely up Slowly and steadily push the plunger back down over about 25 seconds until it is in the complete down position tried to pull the plunger up and it snapped back down What should do Try slowly pulling the plunger up again but count the full 5 seconds before releasing or reversing the direc
22. eave behind a sticky residue Use warm soapy water and roll your finger around the attachment site his motion will remove the sticky adhesive residue You could use a medical adhesive remover instead Ask your doctor or healthcare professional to recommend an adhesive remover Step 9 Dispose of the V Go Discard the used V Go according to local disposal requirements NOTE When used as directed the V Go needle is never exposed It comes out only when the device is attached to the skin After use the needle is retracted back into the V Go and locked Once retracted the V Go needle is completely contained covered Check to make sure the needle is retracted If it is not repeat Step 8C prior to disposal of the V Go 29 SECTION 3 V Go SAFETY INFORMATION The V Go is a safe and reliable device As with many medical devices you must be aware of safety related issues to make sure that you are using the V Go correctly Always consult with your doctor or healthcare professional if you have any questions regarding the functions and operation of the V Go Caution Federal United States law restricts this device to sale by or on the order of a physician or properly licensed practitioner prescription only Indication V Go 20 The V Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24 hour time period 0 83 U hr and on demand bolu
23. entage Error Ep MAX EpMIN Zeroerror V Go 30 Day Trumpet Curve 1000 80 0 V Go 30 Day Start up Graph e 5 E n 20 0 2 08 E E E 0 0 3 1 66 E i ar i Z ji 1 25 mo 00 0 83 A 40 0 0 42 o ao 0 00 80 0 60 120 180 240 300 360 420 480 540 600 650 720 100 0 Time min Time min 30 Units per Day Specification 30 Units Day Overall Percentage Error Ep MAX EpMIN Zero error V Go 40 Day Trumpet Curve 100 0 80 0 V Go 40 Day Start up Graph 374 60 0 3 32 s apo n 1 200 249 5 l 2 208 0 0 1 66 Cea 8 20 0 100 200 300 400 500 amp no 700 1 25 40 0 i 0 83 042 60 0 0 00 8D O 0 60 120 180 240 300 360 420 480 540 600 660 720 100 0 Time min Time min 40 Units per Day Specification 40 Units Day Overall Percentage Error Ep MAX EpMIM Zero error 38 SECTION 5 V Go USER ASSISTANCE INFORMATION SECTION 6 TROUBLESHOOTING FREQUENTLY ASKED QUESTIONS Valeritas Customer Care You may have questions or concerns when you use a new product Please contact us for advice or assistance A trained staff member will help you with any questions on how to fill apply or use the V Go For specific treatment questions information on insulin or medical advice call your doctor or healthcare professional If you have any questions regarding the operation of the V Go or EZ Fill spe
24. enting further bolus doses Plan your day so that you have enough insulin for each meal 24 i Needle Release Button A To administer 2 Units of insulin at mealtime 1 Slide your finger with pressure to locate and press the bolus ready button on the long edge of the V Go e The bolus delivery button located at the end of the V Go will pop out You will hear a Click 2 Push the bolus delivery button all the way into the V Go until it stops You will hear another Click e You have just delivered 2 Units of insulin 1 push 2 Units IMPORTANT Do not touch the needle release button button with ridges while giving yourself bolus doses This may cause you to retract the needle before the end of its 24 hour use and stop the delivery of insulin to your body If this occurs and the needle button pops out remove the V Go and replace it with a new one 25 B Repeat Step 6A until you reach the number of bolus doses prescribed by your doctor or healthcare professional for that specified time NOTE Each push of the bolus delivery button delivers 2 Units of insulin 1 push 2 Units IMPORTANT If you do not know the number of insulin units you have just delivered or if you lose count STOP bolus dosing monitor your blood glucose and follow the plan agreed upon with your doctor or healthcare professional If you have not agreed upon a plan already consult your doctor or healthcare professional for guidance
25. face can reduce the strength of the adhesive 2 Keep the adhesive pad intact and clean before you place it on the infusion site met 22 D Without touching the adhesive pad press the V Go against the skin at the cleaned needle mm 7 infusion site es E Hold the V Go in place for 5 10 seconds Run your finger around the entire edge of the adhesive pad to make sure it is attached to your body Do not accidentally press any of the buttons NOTE When you apply the V Go to the abdomen attach the V Go horizontally at a slight downward angle This allows any tiny air bubbles to travel away from the needle Step 5 Start the 24 hour flow of insulin with the V Go Press down on the raised bump of the needle button with one firm quick motion Needle button needs to be pressed completely into the V Go until you hear a E click or button locks in place This begins the flow of 5c insulin The V Go delivers a continuous preset basal ps ri rate of insulin over 24 hours NOTE Grasp the side of the V Go as you press the raised bump of the needle button to keep the V Go in place Be careful not to press any other buttons during this process IMPORTANT Needle button must lock in place to begin the flow of insulin 23 IMPORTANT Avoid exposing the V Go to direct sunlight Avoid extremely hot temperatures Remove the V Go prior to hot tub whirlpool or sauna use and replace with a new filled V Go af
26. ile and protected within the V Go Do not touch the underside of the V Go after you remove it from the sterile blister packaging If you place the V Go on a surface do not let the underside touch that surface Gently lay the V Go on the front side of the device 2 If the underside of the V Go touches something you must wipe the underside with an alcohol swab 3 Do not touch the circular opening on the top of the EZ Fill plug If you place the plug on a surface do not let the circular opening touch that surface If the circular opening touches something you must wipe the circular opening with an alcohol swab 4 Wipe the infusion site of your skin with an alcohol swab Let the alcohol dry before you attach the V Go Do not touch this site again before putting the V Go on your skin Step 2 Place the V Go into the EZ Fill A Hold the EZ Fill so that the plunger is on the top right side of the EZ Fill B With your other hand place the V Go into the EZ Fill drawer upside down Place the adhesive side facing up with the plastic tab toward the bottom of the EZ Fill The button cover should be facing down into the drawer and toward the top of the EZ Fill SECTION 2 Part 2 FILLING THE V Go WITH INSULIN USING THE EZ FILL IMPORTANT The EZ Fill is intended to fill one 1 V Go each day Use the EZ Fill to fill 30 V Go devices one 1 V Go each day Then discard the EZ Fill after 30 fills A new EZ Fill wil
27. ions in Section 4 Can wear the V Go on an airplane Yes the V Go can safely be worn on an airplane Should wear the V Go to bed Yes you should wear the V Go for a full 24 hours even while you sleep The needle will not retract back into the V Go Try to slide and press the needle release button again See Section 2 Part 3 Step 8C If the needle still will not retract into the V Go dispose of the V Go in a sharps container 47 SECTION 7 GLOSSARY AND PACKAGING SYMBOLS Aseptic technique This process helps keep the V Go M and EZ Fill devices clean during preparation filling and application Following this technique requires hand washing and wiping the application site with an alcohol swab It may involve wiping the V Go device with an alcohol swab if the device comes into contact with anything else Basal rate The basal rate is the amount of insulin delivered at a preset rate by the V Go over 24 hours Your basal rate is the amount of insulin required to maintain your target glucose values when you are not eating Basal rate may also be referred to as background continuous or long acting insulin Blood glucose levels Blood glucose levels are the measure of how much sugar is in the blood Bolus A bolus is an amount of insulin delivered at one time A bolus is usually taken before a meal to cover your body s insulin needs A bolus of insulin can also be taken when blood glucose levels are abnormally high Bolus ma
28. l be included in each month s supply of V Go devices Do not fill and store V Go devices ahead of time That may result in the loss of insulin effectiveness C Slide the V Go up into the EZ Fill drawer Press the V Go flat with the top of the drawer Hold the V Go down with your thumb e Make sure that the adhesive backing on the V Go fits inside the drawer Remove the EZ Fill from the refrigerator allowing the insulin to reach room temperature about 20 minutes before filling the V Go Step 1 Remove the plug from the EZ Fill drawer NOTE On day 1 when you remove the EZ Fill from the packaging the plug will be separate from the EZ Fill therefore you can skip Step 1 A Place your thumb over the plug tab and your forefinger underneath the ribbed drawer handle Pull the drawer out until it stops The plug will pop up from the drawer B Lift the plug out of the EZ Fill using your thumb and forefinger Set the plug aside You will replace the plug into the EZ Fill after you fill the V Go with insulin A D Push the drawer all the way closed IMPORTANT Shut the EZ Fill drawer only when the V Go is completely inside the drawer The drawer is shut when it cannot be pushed any further forward or in IMPORTANT People should not touch the circular opening on the top of the plug Touching the circular opening may compromise the sterility of the EZ Fill Step 3 Place the insulin vial into the EZ Fill ins
29. l the V Go 3 You did not completely pull the plunger to its full upright position e fthis is the case slowly pull the plunger up completely and repeat the filling process for the V Go 4 You have pushed down the plunger too quickly which turned the insulin foamy The foam could become an air bubble larger than a grain of rice e fthis is the case the EZ Fill cannot correct this error at this time Set the V Go aside for use on the next day and start over with a new V Go he V Go with the foamy insulin should be stored with the insulin port up Before using this V Go refill it completely with insulin See Section 2 Part 2 otep 4A to 4F Refer to the V Go storage conditions in Section 4 41 5 The EZ Fill drawer may not be completely closed e lf this is the case check again to ensure the drawer is pushed all the way closed In any of these situations follow Step 4A to 4F to make sure you have a complete fill am looking in the viewing window while pushing the plunger down but I don t see the V Go filling There are 2 reasons you may not see any insulin fill the V Go 1 You have run out of insulin in your vial You have to switch vials before you can fill the rest of the V Go e lf this is the case keep the V Go in the EZ Fill drawer Remove the insulin vial from the EZ Fill insulin vial holder replace with a new vial and refill the V Go 2 You did not completely shut the EZ Fill drawer e Grip th
30. lthcare professional for specific products and recommendations Infections at the site may also occur If you experience redness irritation or inflammation around the V Go specifically the end closest to the needle immediately replace the V Go with a new V Go on a new body site Contact your doctor or healthcare professional for the best way to treat infection and irritation especially if the inflamed site appears bigger than a dime 45 dropped the V Go M Check to see if there is any damage to the V Go If you suspect that the V Go was damaged or became dirty as a result of the fall do not use this one Replace with a new V Go dropped the EZ Fill Check to see if there is any damage to the EZ Fill or the insulin vial if it was attached If the insulin vial came out of the EZ Fill wipe the top of the vial with an alcohol swab and watch closely for leaks when you place the vial back into the EZ Fill If insulin is leaking replace the insulin vial with a new one If you suspect that the EZ Fill was damaged speak to a Valeritas Customer Care Representative at 1 866 881 1209 The V Go was exposed to water Is this a problem The V Go can go under water up to 3 feet 3 inches 1 meter and will continue to work safely You should check to see that it stays in place Depending on the cleanliness of the water you may be at an increased risk for an infection at the needle infusion site Can swim scuba dive shower or ba
31. ments GO DISPOSABLE INSULIN DELIVERY 40 Units 24 hr 1 67 U hr basal rate and up to 36 Units of on demand bolus dosing in 2 Unit increments 96 Units of insulin are available for on demand bolus dosing in all V Go options Bolus doses are delivered in 2 Unit increments You can only push the bolus delivery button 18 times in every 24 hour period Each push of the bolus delivery button delivers 2 Units of insulin 1 push 2 Units IMPORTANT A separate prescription for insulin is required for use with the V Go A U100 fast acting insulin should be used to fill the V Go See Section 3 for insulins tested with the V Go e V Go 20 requires two 2 vials of insulin e V Go 30 and 40 require three 3 vials of insulin IMPORTANT Let your healthcare professional know how much insulin you actually take each day Your healthcare professional will help select the correct V Go option for you The correct V Go option may lessen the risk of hypoglycemia IMPORTANT A V Go Disposable Insulin Delivery Device that has been properly prescribed and used will deliver your insulin needs Wear each V Go for a full 24 hour period including while you sleep IMPORTANT Do not use other insulin products while on V Go therapy Valeritas Customer Care SECTION 2 Part 1 V Go OPERATING INSTRUCTIONS If you have any questions about using the V Go or EZ Fill speak to a Valeritas Customer Care Representative 24 7 at 1 866 881 120
32. ndow Shows a view of the insulin remaining in the insulin vial Plunger When you pull this handle slowly up about 5 seconds and then push it down about 25 seconds insulin transfers from the vial into the V Go Grip The left thumb occupies this groove throughout most of the filling process Drawer The V Go is placed in this drawer for filling The plug sits in the drawer when the EZ Fill is not in use Ribbed Drawer Handle A grooved piece at the bottom end of the EZ Fill that helps with opening and closing the drawer Plug When placed in the drawer the plug protects the EZ Fill components between each fill Aseptic Technique Aseptic technique helps keep the V Go and the EZ Fill devices clean during preparation filling and application Following this technique requires hand washing and wiping the application site with an alcohol swab It may involve wiping the V Go device with an alcohol swab if the device comes into contact with anything else Use aseptic technique when you are preparing filling and attaching a new V Go 1 Inserting a needle into your skin creates an opening where germs can enter your body This could cause an infection at the infusion site Always use aseptic technique The V Go EZ Fill and other supplies come to you sterilized To keep them that way follow these precautions a Always wash your hands thoroughly before preparing filling and attaching the V Go b The infusion needle is ster
33. njections 49 90 Packaging Symbols R Rx Only A store at Unless opened or damaged contents are sterile 9 Do not reuse 3 Dispose of after 30 fills be Use by A Before using contents read the Instructions for Patient Use Lot code 91 Humalog is a registered trademark of Eli Lilly and Company NovoLog is a registered trademark of Novo Nordisk A S e 9 DISPOSABLE INSULIN DELIVERY WWW go vgo com ART 037 Rev H 09 2011 2011 Valeritas Inc valeritas www valeritas com
34. ok at the entire viewing window to make sure that the V Go has been filled completely with insulin You should see only fluid and no air space Viewing Window B Rotate the V Go and look in the viewing window The viewing window will show you if there are any large air bubbles IMPORTANT If you see air bubbles larger than a grain of rice the V Go may not be filled completely Repeat Step 4A to 4F in Section 2 Part 2 to ensure a complete fill Having a few small bubbles is normal and harmless As discussed in Section 2 Part 2 you should slowly and steadily push the plunger down for about 25 seconds to reduce air bubbles as you fill the V Go C When the insulin is full in the viewing window you are ready to attach the V Go to your body IMPORTANT To receive your total 24 hour dose of insulin always start with a V Go that has been completely filled with insulin Do not attach a partially filled or empty V Go to your body If the V Go is not filled completely with insulin repeat Step 4A to 4F in Section 2 Part 2 Step 2 Wash your hands Always wash your hands thoroughly before preparing the V Go for use Use aseptic technique when you are preparing and applying a new V Go See the end of section 2 Part 1 for a description of aseptic technique Step 3 Select and prepare the infusion site IMPORTANT The place on your body where you attach the V Go is important for the success of your therapy Choose a loc
35. orption of insulin The new site should be at least 1 inch away from the previous site 6 Do not apply the V Go to a site that has excess hair or is irritated infected or unhealthy for any reason Consult with your doctor or healthcare professional about how to prepare and maintain these sites 7 Avoid attaching the V Go to sites that may interfere with your clothing accessories or car seatbelts 8 Do not attach the V Go to sites with rigorous movement and stretching due to exercise or job related activities 33 Hypoglycemia Low blood sugar is the most common side effect associated with any insulin including the insulin delivered using the V Go M Symptoms of low blood sugar may vary and can happen suddenly To help prevent hypoglycemic episodes follow these precautionary steps 1 Know the symptoms of hypoglycemia Do not ignore these symptoms no matter how mild they may be 2 Always carry a fast acting sugar replacement such as candy juice or glucose tablets in the event of a hypoglycemic episode 3 Ihe V Go delivery rate can vary by up to 10 from device to device Even though the chance of this happening is remote you should monitor your glucose level at least 3 times per day or as recommended by your doctor Your doctor or healthcare professional may recommend specific times for you to check your blood glucose 4 Check your blood glucose before driving or operating heavy machinery Appropriate blood gluc
36. ose levels are required to maintain alertness IMPORTANT If your glucose level falls below 70 mg dL you may be hypoglycemic low blood sugar and you should take immediate action to raise your blood glucose level This may be done by taking glucose tablets eating candy drinking juice or doing as your doctor or healthcare professional instructs You should retest your blood glucose after 15 minutes and if it is still below 70 mg dL continue to take steps to increase your blood glucose level until it reaches your normal level Consult with your doctor or healthcare professional to understand how to best recognize and manage low blood glucose Hyperglycemia and Diabetic Ketoacidosis DKA To help prevent serious hyperglycemia high blood sugar and the possibility of diabetic ketoacidosis DKA follow these precautions 1 Check your blood glucose frequently based on your doctor s or healthcare professional s recommendation Your doctor or healthcare professional may recommend specific times for you to check your blood glucose 34 IMPORTANT Nausea and vomiting are often the first signs of DKA To avoid DKA be prepared and act quickly Don t assume your blood glucose is high because you are under stress have the flu or miscalculated your last meal bolus 2 Be sure you know when to test for ketones and when your doctor or healthcare professional expects you to call with results 3 Know your blood glucose target ranges and
37. rs of use it is time to replace the current V Go with a new filled V Go Remember to fill the V Go with insulin using the EZ Fill and attach the V Go to your skin immediately after filling The V Go is meant to be worn for 24 hours only Establishing a daily routine will help remind you to change the V Go every 24 hours A Start by filling a new V Go with insulin Follow previous instructions in section 2 Part 2 Steps 1 to 6 e Make sure the V Go is completely filled with insulin before you attach B Set the new filled V Go aside until you remove the used V Go from your skin NOTE Do not block the needle button with your finger or any part of your hand or clothing while releasing the needle via the needle release button 2 C To remove the used V Go place thumb on the ridged section of the needle release button Slide tins nm Slide the needle release button along the side of the e V Go In a continuous motion press the needle T Q release button directly into the V Go until you NC w 5 hear a click This motion retracts the needle l G D At this point the needle button will pop out automatically Ana 28 E To remove the V Go from your skin run a finger under an edge of the adhesive pad F Press lightly on the skin adjacent to the V Go with A one hand and peel the V Go away from your skin E with the other hand Peel Zw NOTE After you remove the V Go the adhesive may l
38. s dosing in 2 Unit increments up to 36 Units per one 24 hour time period in adult patients requiring insulin V Go 30 The V Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24 hour time period 1 25 U hr and on demand bolus dosing in 2 Unit increments up to 36 Units per one 24 hour time period in adult patients requiring insulin V Go 40 The V Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24 hour time period 1 67 U hr and on demand bolus dosing in 2 Unit increments up to 36 Units per one 24 hour time period in adult patients requiring insulin A U100 fast acting insulin should be used with the V Go Humalog insulin lispro rDNA origin and NovoLog insulin aspart rDNA origin have been tested by Valeritas Inc and found to be safe for use in the V Go Disposable Insulin Delivery Device Before using different insulin with the V Go you should check the insulin label to make sure it can be used with this device 30 Healthcare Professional Dosing Considerations When selecting a V Go option healthcare professionals should refer to their own experience when initiating continuous subcutaneous insulin infusion therapy with a patient If unfamiliar the healthcare professional should refer to insulin therapy guidelines from diabetes associations The following should be considered when
39. s smaller than a grain of rice e f the V Go is not filled fully check to see if you still have insulin in your vial f you do not replace vial Step 3 and repeat Step 4A to 4F f you do repeat Step 4A to 4F IMPORTANT Make sure the V Go is completely full of insulin before removing from the EZ Fill If the V Go does not appear completely full repeat Step 4A to 4F Step 5 Remove the V Go from the EZ Fill A Hold the EZ Fill in a sideways position B Pull the EZ Fill ribbed drawer handle all the way P out Pull until the V Go pops up from the drawer C Remove the filled V Go from the EZ Fill by lifting it up with your thumb and forefinger P e Leave the plunger in the down position mnm 0 REMINDER Fill only one 1 V Go each day Fill LF the V Go on the day you use it and attach the 4 P V Go to your skin immediately after filling it wv with insulin Step 6 Store the EZ Fill and unfilled V Go devices after each day s V Go filling session A Place the plug back into the EZ Fill Follow the directions for filling Step 2A to 2D This time use the plug and not a V Go D j NOTE Do not remove the insulin vial from the A EZ Fill The insulin vial should be removed only A when the vial is empty IMPORTANT To make sure the EZ Fill remains sterile e Replace the plug after each fill e Wipe the circular opening on top of the plug i with an alcohol swab before placing the
40. terward IMPORTANT If the needle button does not fully depress or does not remain in the down position the V Go cannot function You will not receive the preset basal rate of insulin Do not use the V Go if the needle button does not stay down Remove and discard that V Go Start over with a new V Go Once the needle button is pushed down and locks into place insulin is now flowing into your body The needle within the V Go remains in your body for the entire 24 hour use of the V Go The V Go design helps to minimize discomfort IMPORTANT Stop all your previous insulin injections and do not use any other insulin in conjunction with the V Go Disposable Insulin Delivery Device NOTE You should check the area around the V Go at regular intervals for redness irritation and inflammation Step 6 Bolus dose with the V Go at mealtimes Your doctor or healthcare professional should have instructed you on how and when to use the V Go and how many bolus doses to administer at mealtimes Consult your doctor or healthcare professional if you have questions regarding your specific bolus dosing needs IMPORTANT Fach V Go has a total of 36 Units of insulin available for on demand bolus dosing per 24 hour period The 36 Units of insulin can only be delivered in 2 Unit increments 1 push 2 Units You can only push the bolus delivery button 18 times in every 24 hour period After 18 uses the bolus delivery button will pop out and lock prev
41. the while wearing the V Go The V Go has been successfully tested in water to depths of 3 feet 3 inches 1 meter for 24 hours and therefore can be worn during normal daily activities such as showering and bathing as well as activities near the surface of the water such as swimming The V Go has not been tested and therefore should not be used in the following conditions e Water activities below 3 feet 3 inches 1 meter such as scuba diving e Extremely hot water temperatures such as hot tubs or whirlpools Remove the V Go prior to scuba diving hot tub use or whirlpool use and replace with a new filled V Go afterward 46 Can wear the V Go for longer than 24 hours for example if sleep an extra hour on the weekend The V Go has been designed for 24 hour wear You should change it at the same time each day After 24 hours the V Go may no longer deliver a continuous preset basal rate of insulin How do travel with the V Go Use the same precautions that you would when traveling with other insulin supplies opeak with your doctor or healthcare professional about extra precautions you may need to take while traveling When traveling with the EZ Fill with an insulin vial attached it should be refrigerated at all times Empty V Go devices do not require refrigeration They should be stored according to the storage conditions in Section 4 For information on storing filled V Go devices refer to the V Go storage condit
42. tion of the plunger The plunger snaps back down if you try to pull the plunger up and release it in less than 5 seconds After place the V Go into the EZ Fill drawer what happens if the plunger is already in the up position You can still fill the V Go Hold the EZ Fill upwards and slowly and steadily push the plunger down over about 25 seconds until it is in the complete down position As you push the plunger down check to make sure insulin enters the V Go Repeat the plunger cycle if no insulin entered the V Go or if additional insulin is required to fill the V Go See Section 2 Part 2 Step 4A to 4F did not apply the V Go directly after filling Do have to throw it away It is preferable to apply the V Go immediately after filling However refer to the V Go storage conditions in Section 4 and the specific insulin s storage conditions for more information believe an item is missing or appears to be damaged If you suspect an item is damaged do not use the damaged piece Replace this with a new one V Go or EZ Fill EZ Fill replacements can be requested from a Valeritas Customer Care Representative at 1 866 881 1209 43 believe have broken the EZ Fill How do I get another one to fill the V Go EZ Fill replacements can be requested from a Valeritas Customer Care Representative at 1 866 881 1209 You will be asked to return the unusable EZ Fill Valeritas Customer Care will provide you with further details The
43. tures over 99 F for prolonged periods of time beyond 14 hours as this may lead to degradation of the insulin check the insulin manufacturer s instructions for use for temperature details and may cause the V Go to run at a basal rate Slightly greater than the specified range Operating Atmospheric Pressure 697 hPa to 1 013 hPa Equivalent to altitudes up to 10 000 feet 3 048 meters Duration of Use Bolus Delivery Accuracy 10 For all 3 V Go options Basal Delivery Accuracy 10 For all 3 V Go options Enclosure Protection Protects against the effects of submersion at depths up to 3 feet 3 inches 1 meter for 24 hours IPX8 Needle 4 6 mm 30 gauge needle with sharps injury prevention features and floating needle technology 37 36 Delivery Accuracy Test Results The following graphs show the basal flow rate accuracy for all 3 V Go M options 20 30 40 for the given time periods The bolus accuracy is 10 for all 3 V Go options Flow Rate Start up Graphs Flow Rate Test Period Graphs V Go 20 Day Trumpet Curve V Go 20 Day Start up Graph Day p 100 0 80 0 1 66 t 60 0 gt 5 200 5 083 47 HI a a a E 200 0 60 120 180 240 300 360 420 480 540 600 660 720 0 42 2 40 0 0 00 60 0 0 60 120 180 240 300 360 420 480 540 600 660 720 80 0 Time min 100 0 Time min 20 Units per Day Rate Specification 20 Units Day Rate Overall Perc
44. ulin vial holder Step 4 Fill the V Go with insulin A Hold the EZ Fill upright over a counter or table by placing your thumb across the grip The grip is just below the insulin vial holder and the plunger Use the rest of your hand to support the back of the EZ Fill NOTE Before placing a new vial into the EZ Fill check to make sure the insulin vial is not expired and that it will not expire during the time period that the vial will be used in the EZ Fill e Do not block light from the back of the EZ Fill Light from the back will help you see the viewing window A Remove the protective cap from the insulin vial Wipe the top with an alcohol swab NOTE Keep the EZ Fill in a vertical fully upright position during filling s s Keep the viewing window at eye level Direct the backside of the EZ Fill toward G E a brightly lit area when you fill the V Go This makes it easier to see the flow of insulin Insulin insulin Seeing the flow of insulin helps you fill the V Go properly and completely r B Slowly pull the plunger up to its full upright position with your free hand and wait 5 seconds y B Pull the EZ Fill cap out of the insulin vial holder i IMPORTANT Make sure you slowly pull the T and discard plunger up as far as it can go u C Make sure the viewing window is at eye level so you can watch the V Go fill with insulin i C Turn the insulin vial upside down so the top of the l L vial fa
45. when your doctor or healthcare professional expects you to report trouble When your blood glucose is high be prepared to administer insulin If you suspect that the V Go is not delivering insulin refer to the Troubleshooting section of this manual on page 41 4 Keep yourself well hydrated especially during illness or exercise 5 Do not treat DKA yourself If you suspect DKA contact your doctor or healthcare professional Adverse Reactions Site Infection Abscesses Infections at the infusion site may occur Proper site preparation and frequent site rotation refer to Section 2 Part 3 Step 3A to 3D can minimize infections Remove the V Go immediately if the area around the V Go becomes sore red or swollen Apply a new V Go to a new clean site away from the suspected infected area Do not discontinue therapy without the advice of your doctor or healthcare professional Skin Irritation A more common problem than infection is skin irritation Skin may become irritated by the adhesive pad on the V Go or by the way the V Go is positioned on your skin okin irritation can occur but does not lead to any further clinical complication NOTE If you have sensitive skin or your skin becomes irritated ask your doctor or healthcare professional about skin barrier products 35 V Go SECTION 4 PRODUCT SPECIFICATIONS Basal Delivery 20 Units 24 hr 0 83 U hr Continuous Subcutaneous 30 Units 24 hr 1 25 U hr EZ Fill 40 Units 24 hr
46. y also be referred to as mealtime prandial short acting or rapid acting insulin Diabetes mellitus Diabetes is a disease in which the body cannot maintain its own healthy blood glucose levels Either the body cannot produce enough insulin or the body cannot properly use insulin There are two main types of diabetes Type 1 diabetes In Type 1 diabetes the body does not produce enough insulin People with Type 1 diabetes must use insulin to regulate their blood glucose levels Type 2 diabetes In Type 2 diabetes the body does not produce enough insulin or use it properly People with Type 2 diabetes can usually regulate their blood glucose levels by following an individual meal plan exercising and taking certain medicines including insulin if needed It usually occurs in people 40 years or older 48 Diabetic ketoacidosis DKA DKA occurs when the blood glucose level is elevated and the insulin level is low The body does not have enough insulin to help the glucose enter the cells Glucose in the cells is used for energy During this situation the body begins to burn muscle and fat for energy A waste product of fat burning is ketones Ketones accumulate in the blood and are passed through the urine and lungs This condition can be identified by urine and or blood tests DKA usually requires hospitalization and can lead to a life threatening situation if not promptly treated Glucose Glucose a sugar is a main way the body takes
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