Novo Nordisk NovoPen 3 PenMate, Instruction Manual

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Page 2: ...tible and allow the device to function safely and effectively 23 NovoPen 3 PenMate is designed to be used with 24 NovoPen 3 25 PenFill 3 mL cartridges 26 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 Its 30 design allows you to use the same recommended injectio...

Page 3: ...should use 41 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 insulin 44 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 devi...

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Page 5: ...NovoPen 3 PenMate Instruction Manual Page 5 FDA revision 4 final 52 PenFill Holder ...

Page 6: ...and each step thoroughly 65 Also included is a diagram showing a side by side comparison of the NovoPen 3 and the 66 NovoPen 3 PenMate This illustration allows you to see which part of the NovoPen 3 the 67 NovoPen 3 PenMate replaces 68 69 The main differences between the NovoPen 3 and the NovoPen 3 PenMate are as 70 follows 71 The PenFill cartridge holder and the Pen cap of the NovoPen 3 are repla...

Page 7: ...ECTION 4 94 Giving the injection 12 95 SECTION 5 96 Mechanical function check of NovoPen 3 PenMate 17 97 SECTION 6 98 For subsequent injections 18 99 SECTION 7 100 What to do when PenFill is nearly empty 19 101 SECTION 8 102 Changing PenFill 20 103 SECTION 9 104 Function check 21 105 IMPORTANT 22 106 WHAT TO DO IF 25 107 HOW TO STORE AND LOOK AFTER YOUR 108 NOVOPEN 3 AND YOUR NOVOPEN 3 PENMATE 27 ...

Page 8: ...sembly of the NovoPen3 PenMate 114 Assembly of the NovoPen 3 PenMate 115 116 1 Take NovoPen 3 out of its case by pressing the top of the pen cap 117 118 119 2 Gently twist the pen cap until it separates from the barrel 120 121 3 Pull the pen cap straight up to remove it 122 123 ...

Page 9: ...f you want to use NovoPen 3 without NovoPen 3 PenMate 128 in the future 129 SECTION 1 cont 130 5 The end of the piston rod should be flat against the end of the reset mechanism prior to 131 inserting each new Novolin PenFill 3 mL cartridge It should not be sticking out 132 133 If the piston rod is sticking out 134 Turn the end of the reset mechanism in a clockwise direction until the piston rod is...

Page 10: ...od again until it is time to remove the used PenFill 3 mL 140 cartridge and insert a new one 141 142 If the reset mechanism locks it is usually due to improper technique Gently turn the 143 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 145 146 ...

Page 11: ...n until zero 0 appears in the window The zero 149 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 foil 151 side of the packaging 152 Before use check that the PenFill cartridge is full and intact If not do not use it 153 154 ...

Page 12: ...10 times or until the insulin looks uniformly white 160 and cloudy 161 162 163 If you use more than one type N R or 70 30 of insulin use a separate NovoPen 3 164 PenMate for each type 165 166 Once the cartridge is punctured it can be used at room temperature for the length of time 167 identified in the storage information section of the Information For The Patient supplied 168 with the PenFill car...

Page 13: ... is aligned with 179 the yellow push button on NovoPen 3 PenMate 180 181 182 Each PenFill 3 mL cartridge contains a total of 300 units of insulin There are five 183 cartridges in a box Make sure you are using the correct type of insulin The name of 184 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 anyo...

Page 14: ...with an alcohol swab before each injection even 195 if you are using the same PenFill cartridge 196 197 198 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 before 203 each ...

Page 15: ...orm an air shot prior to each injection 221 222 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 tap 224 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 pr...

Page 16: ...or the injection To activate grip the barrel and the NovoPen 3 PenMate 245 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 the 248 instructions on page 11 249 250 251 13 Dial the number of units you need to inject 252 The odd numbers are shown as fu...

Page 17: ...he dose to 260 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 to 264 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 hold 267 of them see picture 268 b Press the push button on the barrel back to zero 0...

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Page 19: ...airshot see page 9 and choosing your dose hold the NovoPen 3 PenMate 282 at the correct site on the body for an injection Use the injection technique 283 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 arr...

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Page 21: ...ain under the skin for several seconds Keep the 294 push button fully depressed until the needle has been withdrawn from the skin 295 If there is not enough insulin in the PenFill cartridge for the whole dose you will be 296 able to see the number of units you still need to inject in the dose indicator window 297 You must always check this after you have given the injection 298 299 Important Never...

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Page 23: ...dose indicator window 316 b Remove the NovoFine needle see Section 5 317 c Remove the empty Novolin PenFill 3 mL cartridge see Section 8 318 d Insert a new Novolin PenFill 3 mL cartridge see Section 1 319 e Attach a new NovoFine needle see Section 1 320 f Do an air shot see Section 2 321 g Dial the number of units noted in step a 322 h Give the injection 323 324 SECTION 4 cont 325 To make sure tha...

Page 24: ...nMate firmly while you unscrew the NovoFine disposable needle Place the 340 NovoFine disposable needle in a puncture resistant disposable container 341 Health care professionals relatives and other caregivers should follow precautionary 342 measures for removal and disposal of needles to eliminate the risk of unintended 343 needle penetration 344 345 346 347 Graphic to be changed ...

Page 25: ...sh 352 disposal authorities 353 354 SECTION 5 Mechanical function check 355 356 Mechanical function check of NovoPen 3 PenMate 357 18 Hold the NovoPen 3 PenMate with the needle pointing upwards 358 To activate grip the barrel and the PenFill holder of the NovoPen 3 PenMate and 359 firmly pull in opposite directions until you hear a click If you do not hear a click 360 contact Customer Relations at...

Page 26: ...ush the yellow push button and the needle should appear 368 You should now be able to see the needle and the control line 369 If you cannot see the needle do not use the NovoPen 3 PenMate Never use the 370 NovoPen 3 PenMate unless you are sure that it is working properly 371 ...

Page 27: ...NovoPen 3 PenMate Instruction Manual Page 27 FDA revision 4 final 372 Need Help Call 1 800 727 6500 373 374 SECTION 6 For subsequent injections 375 376 ...

Page 28: ... 380 insulin PenFill cartridge such as Novolin R follow steps 9 to 17 381 382 21 If your NovoPen 3 PenMate contains an insulin suspension cartridge such as Novolin 383 70 30 or Novolin N mix the insulin by turning the device up and down between 384 positions A and B as shown in the picture The movement must be performed so that 385 the glass ball in the cartridge moves from one end to the other Do...

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Page 30: ...tion window The glass ball must have 398 adequate space to resuspend the insulin With the NovoPen 3 PenMate it is possible 399 to select a dose that is larger than the number of units left in the PenFill cartridge If 400 there is not enough insulin in the PenFill cartridge for the whole dose you will be 401 able to see the number of units you still need to inject in the dose indicator window 402 a...

Page 31: ... final 407 408 When you get near the end of a PenFill cartridge you may need to give yourself two 409 injections to receive your full dose If after giving an injection zero does not appear in 410 the dose indicator window you did not receive your full dose 411 ...

Page 32: ... from the NovoPen 3 PenMate 416 b Press the push button to set the dose indicator to zero 417 c Make sure that the piston rod is not out see Section 1 Page 5 Twist it gently 418 from side to side if necessary 419 420 421 422 423 24 Take out the empty PenFill cartridge Take a new PenFill cartridge and continue 424 as described from steps 6 and 7 425 ...

Page 33: ...n 434 the NovoPen 3 PenMate 435 b Screw on a new NovoFine needle as described in step10 436 c Clear the air bubbles as described in step11 437 d Put the outer needle cap over the needle 438 e Dispense 20 units into the needle cap 439 440 The insulin should fill the lower part of the outer needle cap If the pen has delivered 441 too much or too little insulin repeat the test If it happens again do ...

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Page 35: ...n the PenFill cartridge for your dose 464 After the injection always make sure that you have injected the whole dose by 465 checking that the dose indicator window reads 0 If not see step 22 466 Do not use the insulin scale on the NovoPen 3 PenMate to measure the amount of 467 insulin to be injected 468 Before injecting always check the dose indicator window to make sure you have 469 dialed the co...

Page 36: ...MPORTANT cont 501 Guidelines for storing the NovoPen 3 PenMate and PenFill 3 mL cartridges 502 Store the NovoPen 3 PenMate with the PenFill cartridge inside at room 503 temperature Do not store the NovoPen 3 PenMate in a refrigerator or areas where 504 there may be extreme temperatures or moisture such as your car Once the cartridge 505 is punctured it can be kept at room temperature for the lengt...

Page 37: ...the injection 532 533 Do not try to force the push button down Check if the PenFill cartridge is empty 534 If there was not enough insulin in PenFill cartridge for the whole dose you will see the 535 number of units you still need to inject in the dose indicator window Make a note of this 536 Change the PenFill cartridge and continue as described from step 23 537 538 539 540 541 542 WHAT TO DO IF ...

Page 38: ... PenMate can 569 be damaged Do not drop Do not expose to excessive pressure or blows Keep them in 570 the soft case whenever possible 571 572 You can put PenFill cartridges in NovoPen 3 PenMate or carry them with you as spares 573 Please read the Information For The Patient supplied with the PenFill cartridges 574 for details of how to store the cartridges and how long to keep them 575 576 You can...

Page 39: ... 608 and Bang Olufsen A S cannot beheld responsible in the case of defects or damages 609 arising from 610 611 The use of the NovoPen 3 PenMate with products other than NovoPen 3 PenFill 3 mL 612 cartridges and NovoFine single use disposable needles 613 614 The use of the NovoPen 3 PenMate not in accordance with the instructions in this 615 booklet 616 617 Physical damage to the NovoPen 3 PenMate ...

Page 40: ...NovoPen 3 PenMate Instruction Manual Page 40 FDA revision 4 final 638 2002 Novo Nordisk Pharmaceuticals Inc 639 640 www novonordisk us com 641 ...

Page 41: ... This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature s David Orloff 3 11 02 05 06 34 PM ...