Novo Nordisk NovoPen 3 PenMate User manual

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NovoPen 3 PenMate Instruction Manual
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2NovoPen®33previous page for graphic4PenMate®5
6Instruction Manual
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8Read this carefully9before you use10 NovoPen® 3 PenMate®11 and NovoPen® 312
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16 INTRODUCTION17
NovoPen® 3 PenMate® is a replacement component specifically designed to be used18 with the NovoPen 3 insulin pen. NovoPen 3 PenMate helps you to insert the needle and19 to give injections quickly and easily. With NovoPen 3 and NovoPen 3 PenMate, you can20 dial doses in units of one from 2 to 70 units.21 NovoPen 3 PenMate should only be used in combination with products that are22 compatible and allow the device to function safely and effectively.23 NovoPen 3 PenMate is designed to be used with:24
§NovoPen® 325
§PenFill® 3 mL cartridges26
§NovoFine® 30G/8 mm and NovoFine® 31G/6 mm needles.27
NovoFine disposable needles are for single-use only.28
29 The NovoPen 3 PenMate can be used the same way as the NovoPen 3 insulin pen. Its30 design allows you to use the same recommended injection technique as for the NovoPen31 3 insulin pen.32
33 This booklet contains instructions for using, storing, and cleaning NovoPen 3 PenMate in34 combination with NovoPen 3. Please follow them carefully. You should read these35 instructions even if you have used NovoPen 3, or NovoPen 3 in combination with the36 NovoPen 3 PenMate before. The two following pages provide illustrations of both the37 NovoPen 3 and the NovoPen 3 PenMate.38
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Always check that the PenFill® cartridge you use contains the correct type of insulin.40 If you are treated with more than one type of insulin in PenFill cartridges, you should use41 a separate NovoPen 3 PenMate and NovoPen 3 for each type of insulin.42
43 If you have any questions about your NovoPen 3 PenMate or your NovoPen 3 insulin44 delivery device, please call Novo Nordisk Pharmaceuticals, Inc. at 1-800-727-6500.45 Please complete and return the NovoPen 3 PenMate Warranty Card.46
Thank you for choosing the NovoPen 3 PenMate and NovoPen 3 insulin delivery device.47
Look at the diagram48
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PenFill Holder

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53 HOW TO USE THIS BOOKLET54
This booklet gives you step-by-stepinstructions for using the NovoPen 3 PenMate in55 combination withthe NovoPen 3.56
57 Begin by reviewing the illustration layout of the parts of the NovoPen 3, NovoPen 358 PenMate, PenFill 3 mL cartridge and NovoFine disposable needle. The inside front cover59 opens out so you have a handy reference while you read the rest of the booklet.60 Most pages contain an illustration on the right with numbered instructions to the left of61 the illustration.62 Important additional information is given below the illustration.63 We suggest that you read the text and look at the illustrations to make sure that you64 understand each step thoroughly.65 Also included is a diagram showing a side-by-side comparison of the NovoPen 3 and the66 NovoPen 3 PenMate. This illustration allows you to see which part of the NovoPen 3 the67 NovoPen 3 PenMate replaces.68
69 The main differences between the NovoPen 3 and the NovoPen 3 PenMate are as70 follows:71 The PenFill cartridge holder and the Pen cap of the NovoPen 3 are replaced by the72 NovoPen 3 PenMate.73
NovoPen 3 PenMate allows for automatic insertion of the NovoFine needle under the74 skin; NovoPen 3 requires manual needle insertion.75 NovoPen 3 PenMate allows for the NovoFine needle to be completely hidden prior to76 needle insertion; the needle is visible on the NovoPen 3 prior to needle insertion.77
78 Look at the diagram inside the front cover for the names of the different parts of79 NovoPen 3 and NovoPen 3 PenMate. You can unfold the diagram to help you while80 you follow the instructions.81
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86 TABLE OF CONTENTS87
SECTION 1:88 Assembly of the NovoPen 3 PenMate............................................ 489
SECTION 2:90 Air shot before each injection........................................... 991
SECTION 3:92 Choosing your dose......................................................... 1093
SECTION 4:94 Giving the injection......................................................... 1295
SECTION 5:96 Mechanical function check of NovoPen 3 PenMate.......... 1797
SECTION 6:98 For subsequent injections................................................ 1899
SECTION 7:100 What to do when PenFill is nearly empty......................... 19101
SECTION 8:102 Changing PenFill............................................................ 20103
SECTION 9:104 Function check............................................................... 21105
IMPORTANT................................................................ 22106
WHAT TO DO IF.......................................................... 25107
HOW TO STORE AND LOOK AFTER YOUR108 NOVOPEN 3 AND YOUR NOVOPEN 3 PENMATE... 27109
WARRANTY................................................................. 28110
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SECTION 1 Assembly of the NovoPen3 PenMate114
Assembly of the NovoPen 3 PenMate115
116 1Take NovoPen 3 out of its case by pressing the top of the pen cap.117
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2Gently twist the pen cap until it separates from the barrel.120
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3Pull the pen cap straight up to remove it.122
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4 Unscrew and remove the PenFill holder from the barrel*124
125 * See diagram.126
You will not use the pen cap and PenFill holder with the NovoPen 3 PenMate but you127 should store them in the case if you want to use NovoPen 3 without NovoPen 3 PenMate128 in the future.129
SECTION 1 (cont.)130
5The end of the piston rod should be flat against the end of the reset mechanism prior to131 inserting each new Novolin PenFill 3 mL cartridge. It should not be sticking out.132
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If the piston rod is sticking out:134 Turn the end of the reset mechanism in a clockwise direction until the piston rod is no135 longer sticking out. Never push the piston rod back in.136

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Need Help? Call 1-800-727-6500138
139 You should not reset the piston rod again until it is time to remove the used PenFill 3 mL140 cartridge and insert a new one.141
142 If the reset mechanism locks, it is usually due to improper technique. Gently turn the143 mechanism side to side until it unlocks. Then call our toll free number (1-800-727-6500)144 so that we may review your operating technique with you.145
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SECTION 1 (cont.)148
6Press the push button all the way in until zero (0) appears in the window. The zero149 should be lined up with the stripe below the dose indicator window.150
To remove the PenFill cartridge from its wrapper, push the cartridge through the foil151 side of the packaging.152
Before use, check that the PenFill cartridge is full and intact. If not, do not use it.153
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7If you use Novolin 70/30 [70% NPH, Human Insulin Isophane Suspension and 30%155 Regular, Human Insulin Injection (recombinant DNA origin)] or Novolin N, NPH156 [Human Insulin Isophane Suspension (recombinant DNA origin)], mix the insulin:157
158 a. Turn PenFill cartridge up and down between positions A and B, as shown.159 b. Repeat this mixing step at least 10 times or until the insulin looks uniformly white160 and cloudy.161
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163 If you use more than one type (N, R, or 70/30) of insulin, use a separate NovoPen 3164 PenMate for each type.165
166 Once the cartridge is punctured, it can be used at room temperature for the length of time167 identified in the storage information section of the Information For The Patient supplied168 with the PenFill cartridges. The expiration date on the cartridge is for unused cartridges169 under refrigeration.170
171 SECTION 1 (cont.)172
Take the NovoPen 3 PenMate out of its case.173 Pull off the pen cap and put it to one side.174

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Put the PenFill cartridge into the NovoPen 3 PenMate.175 The threaded plastic cap goes in first.176
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8Tightly screw the barrel of the NovoPen 3 into the NovoPen 3 PenMate.178 Make sure that the dose indicator window on the mechanical section is aligned with179 the yellow push button on NovoPen 3 PenMate.180
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182 Each PenFill 3 mL cartridge contains a total of 300 units of insulin. There are five183 cartridges in a box. Make sure you are using the correct type of insulin. The name of184 the insulin is on the glass part of the cartridge.185 Each PenFill cartridge is for single-person use only.186 DO NOT share the cartridge with anyone even if you attach a new disposable needle187 for each injection. This will prevent the spread of disease.188

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Use only a new PenFill 3 mL cartridge when loading the NovoPen 3 PenMate.189 Never load a partially filled cartridge. Never try to refill a used PenFill 3 mL190 cartridge.191
192 SECTION 1 (cont.)193
9Clean the front rubber stopper on the PenFill cartridge with an alcohol swab.194
You must wipe the front rubber stopper with an alcohol swab before each injection, even195 if you are using the same PenFill cartridge.196
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10 Remove the protective tab from the NovoFine® disposable needle.199 Screw the NovoFine needle firmly onto the threaded plastic cap until it is tight.200 Pull off the outer and inner needle caps.201
202 For users of Novolin 70/30 or Novolin N insulin: Always remix the insulin before203 each injection.204 To remix the insulin, turn the NovoPen 3 PenMate up and down between positions A205 and B, as on page 4, 10 times or until the insulin looks uniformly white and cloudy.206
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208 Never place a NovoFine disposable needle on your NovoPen 3 PenMate until you are209 ready to do an air shot and give an injection. If the NovoFine needle is “left on”,210 some liquid may leak out of the PenFill cartridge. This may cause a change in the211 strength of Novolin 70/30 or Novolin N insulin.212
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214 SECTION 2 Air shot before each injection215
216 Air shot before each injection217
218 11 The PenFill cartridge may contain an air bubble, and small amounts of air may219 collect in the needle and PenFill cartridge when you use them. To avoid the injection220 of air and ensure proper dosing, you must perform an air shot prior to each injection.221
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§Check that the dial-a-dose selector is set at zero.223
§Dial 2 units. Hold the NovoPen 3 PenMate with the needle upwards and tap224 gently near the window of NovoPen 3 PenMate with your finger a few times.225
§Press the push button at the end of the barrel all the way in.226
227 A drop of insulin should appear at the needle tip.228
If not, repeat the procedure until a drop of insulin appears. There may still be some small229 air bubble(s) in the PenFill cartridge after this, but they will not affect your dose and they230 will not be injected.231
232 If you dial more than 2 units, DO NOT turn the dial back to zero (0). If you do, the233 extra insulin will squirt out of the needle. You may complete the air shot with the234 number of units you have dialed or refer to the instructions on how to reset the dose to235 zero in step 14.236
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SECTION 3 Choosing your dose239
240 Choosing your dose241
242 12 NovoPen 3 PenMate has an insulin scale with marks showing the approximate243 number of units left in the PenFill cartridge. Always check that there is enough244 insulin left for the injection. To activate, grip the barrel and the NovoPen 3 PenMate245 and firmly pull in opposite directions until you hear a click.246
Important: Do not pull the dial-a-dose selector.247
Check that the dial-a-dose selector is set at zero. If zero does not appear, follow the248 instructions on page 11.249
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251 13 Dial the number of units you need to inject.252 The odd numbers are shown as full lines between the even numbers.253 Do not use the clicking sound as a guide for selecting your dose.254
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257 The NovoPen 3 PenMate can deliver from 2 to 70 units of insulin in one unit increments.258 If you dial more than your dose, DO NOT turn the dial back to zero (0). If you do,259 the extra insulin will squirt out of the needle. For instructions on how to reset the dose to260 zero (0) so you can start again, see the next page.261
262 SECTION 3 (cont.)263
14 If you dial a larger dose than you need, you need to reset your NovoPen 3 PenMate to264 zero.265
To reset to zero (0) if you set the wrong dose:266
a. Pull the barrel and the NovoPen 3 PenMate in opposite directions and keep hold267 of them (see picture).268
b. Press the push button on the barrel back to zero (0).269
c. Release your grip and the barrel section will slide back into place.270
d. You can now dial the correct units of insulin.271

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276 SECTION 4 Giving the injection277
278 Giving the injection279
15 Before injecting always check the dose indicator window to make sure you have280 dialed the correct number of units.281 After the airshot (see page 9) and choosing your dose, hold the NovoPen 3 PenMate282 at the correct site on the body for an injection. Use the injection technique283 recommended by your healthcare professional. The PenMate is designed with a cut-284 away on one side. This cut-away allows injections at various angles other than 90°.285 Press the yellow push-button on the NovoPen 3 PenMate with your finger (see arrow286 in diagram). The needle will automatically enter the skin.287
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