User Manual
Contents
1. Do not use grease or any lubricants Do not store the pendiq in the refrigerator Keep it away from moisture dust extreme heat and cold as well as direct sunlight Gently wipe the pen body the pen cap and the pen case with a dry or lightly damp cloth pendiq is a technical device Please use your pendiq considerate and appropriate Please pay attention to the storage advice of the insulin manufacturers 14 Problems I cannot screw the cartridge holder onto the pen body A part of the pens display stays turned on all the time want to turn the pen off have an air bubble in the cartridge after prime A drop of insulin does not appear at the needle tip when I check the insulin flow Check that the cartridge is completely inserted into the cartridge holder Make sure the cartridge holder is completely and securely screwed onto the pen body Your display is not working correctly Contact your local distributor In order to prevent your pen from accidentally being turned off during injection there is no OFF button The screen turns itself off after 60sec when no button is pressed Hold the pen with the needle facing upwards tap with your finger gently against the cartridge holder so that the air bubble rises to the top Start removing air bubbles In case the bubble in the cartridge does not disappear although you repeatedly press for removing air bubble do the following Initiate the process o2. Not yet e Press CACT to confirm and the display will return to the home screen You set the insulin manufacturer once and unless the manufacturer prescribed by your healthcare professional changes you don t have to adjust the cartridge type when inserting a new cartridge After you have set the correct insulin manufacturer in the cartridge setting you need to drive the plunger forward 19 4 5 Driving the plunger forward In case you have screwed a pen needle onto the cartridge holder it is very important that you remove the pen needle again from the cartridge holder before driving the plunger forward Otherwise the insulin will be ejected through the pen needle while driving it forward as the plunger will have no resistance due to the punctured rubber membrane of the insulin cartridge Please make sure that the pen body and the cartridge holder are firmly screwed together before priming In case the screen is turned off press ACT and hold for 3sec to turn on the display example home screen 4 5 Driving the plunger forward e Press M 4x e The display will show four bars L 1 e Press and the priming sign lt will appear e Hold the button for 2 sec to start the priming process e When the plunger starts moving you can let go of the button e Now the plunger will slowly move towards the cartridge and it will stop when the piston rod foot hits the end of the cartrido
3. Open the USB port cover on the side of your pen e Take the USB cable that was delivered with the product box and plug in the end of the USB connection into the USB port of the pen e Connect USB cable with your computer or with a USB charger not contained in the product box to charge your pen e While the pen is charging the LED light will show a flashing green light e When your pen is completely charged the LED light shows a consistent green light and you can remove the charger from your pen 46 11 2 Using the USB cable for the transfer of data e Open the USB port cover on the side of your pen e Plug in the small end of the USB cable into the USB port of your pen e Connect the USB cable with the USB port of your computer e Start diabetes management software To download a Diabetes Management Software that is compatible with the pendig go to the website www pendiq com and check out the site for downloads 47 1 oO Manual Injection mode for emergencies only In case of emergency e g battery empty display failure the pendig is convertible to manual injection mode Manual injection Mode is for emergencies only Do not use manual injection mode while the pen works without E problem in digital mode In manual injection mode pendiq does not register nor recognize the delivered doses The following illustration will show you how to switch pendiq to manual injection mode Push rubber lid back at the
4. The display returns to the home screen time If you want to interrupt or cancel the time and date setting or any operation press MI to return to the home screen 15 4 2 Extension disc for Lily and Berlin Chemie cartridges only For Lilly and Berlin Chemie cartridges the extension disc needs to be used as followed Take the extension disc and attach it to the plunger foot as shown below i The extension disc is only used for Lilly and Berlin Chemie but not for Sanofi Aventis cartridges 16 4 3 Inserting the cartridge 1 Pull off the pen cap 2 Prepare new cartridge s 3 Unscrew the cartridge holder from the pen body 17 18 4 3 Inserting the cartridge 4 Insert anew cartridge into the cartridge holder 5 Screw the cartridge holder and the pen body firmly together Once you have inserted the cartridge you will need to adjust the settings of the pen to the insulin g manufacturer you use 4 4 Cartridge setting e In case the screen is turned off press CACT and hold for 3 sec to turn on the display The home screen will appear Press MI 5x to oo to cartridge setting e Adjust the numbers by pressing C or choosing the type of cartridge manufacturer you need The pendigq is only compatible with the insulin cartridges of the following insulin manufacturers CA01 Sanofi Aventis CAO2 Lilly Berlin Chemie CA03
5. an OK in the right corner of the LCD screen as shown beside driving forward You can interrupt the process of driving the plunger forward or rewinding it at any time by pressing MI The plunger will stop and the display will return to the home screen Follow the instructions to start again from the beginning It is important that you to get familiar with the process of rewinding and driving forward the plunger ao 30 6 2 Changing e Take off the pen cap and unscrew the transparent cartridge holder from the pen body e Take the used cartridge out of the cartridge holder e Insert the new cartridge into the cartridge holder e Screw the cartridge holder and the pen body firmly together e Dispose the used cartridge according to the instructions of the insulin manufacturer 6 3 Driving the plunger forward In case you have screwed a pen needle onto the cartridge holder it is very important that you remove the pen needle again from the cartridge holder before driving the plunger forward Otherwise the insulin will be ejected through u the pen needle while driving it forward as the plunger will have no resistance due to the punctured rubber membrane of the insulin cartridge Please make sure that the pen body and the cartridge holder are firmly screwed together before priming 6 3 Driving the plunger forward e The LCD will now still display the following screen for driving the plunger forward again e Press CACT to start
6. fixed dose for a time segment of your choice pendiq pre programming is convenient because you can pre program a maximum of 9 time segments a day g g each time segment delivering one pre programmed dose 8 1 Programming time segments Press ACT and hold for 3sec to turn on the home screen The remaining amount of insulin is displayed b muag example home screen 37 8 1 Programming time segments e Press M Gx to go to pre programming option as shown beside e Press CACT to enter time segment setting The ton the left side of the display means time segment On the right side of the display you EEE j will see the time segment number flashing time segment number flashing e Choose how many time segments you would like to program by pressing or and confirm by pressing CAG T You can pre program up to 9 time segments example 3 time segments 38 8 1 Programming time segments e After you have confirmed the number of time segments you would like to program the time setting of the first time segment will appear as shown beside e To the left side on the screen you will see the time segment you would like to program To the right side of the screen you can choose when you would like your time segment to start The time format is 24h time segment e Adjust starting time by pressing or and press CACT to confirm A time segment example starting time end
7. if all the following items are contained in the product box e Digital insulin pen pendiq e Pen case e User manual e USB cable e Extension disc for Lilly and Berlin Chemie cartridges only e Warranty card e Registration card 3 2 pendiq components Pen cap Pen body Cartridge holder Cartridge not included Pen needle not included T m gg O U gt Operation buttons C M ACT LCD screen H USB port I Plunger and plunger foot J Dose ring for manual injection only K Extension disc 11 Te 3 3 Operation buttons CACT button is used to turn on the pen to confirm an operation or setting to inject dose to return to home screen M button is used to enter the menu to review memory to cancel an operation or setting display returns to home screen C button is used to increase number to prime to track forward in injection memory to drive the plunger forward C button is used to decrease number to track back in injection memory to rewind the plunger 3 4 Display symbols gt I 0 Tm DOI DU To display operation status numbers symbols etc Battery status Display unit Blockage Insulin cartridge indicator Memory Confirmation z Alarm sound on 1 4 Getting started with your pendiad When you use your pendid for the first time follow the steps below to get started The pendig
8. is automatically shown on the home screen example remaining units S S Handling the pen needle after the injection e Carefully place the outer cap back on the pen needle and unscrew the needle e Dispose the used needle as advised by your healthcare professional or according to local regulations 7 6 Changing the cartridge When the residual amount of insulin in the cartridge is 20 0U or lower the cartridge status sign on the display will start to flash to inform you that you will soon need to change the cartridge To change the cartridge you will first need to rewind the plunger 6 1 Rewinding e Pull off the pen cap You will now see the transparent cartridge holder with the used cartridge e In case there is a pen needle still attached to the cartridge holder remove the pen needle to avoid potential injuries e In case the display is turned off press CACT and hold for Ssec to turn on the display e The LCD screen displays the remaining amount of insulin in the cartridge Press M 4x e The display will show four bars L 1 e Press C and the rewinding sign gt 1 will appear j 28 6 1 Rewinding Hold C for 2sec to start the rewinding process e When the plunger starts moving let go of the button The plunger will now slowly move all the way back rewinding e When the plunger has completely rewound the sign for driving the plunger forward lt will appear with
9. segment is saved in the injection mode So you can deliver the dose quickly and easy e Press and hold CACT for 3 sec to turn on the home screen e Press CACT again to enter injection mode The screen will now display last injection delivered alternating be tween time and amount e Press CACT to proceed to removing air bubbles chapter priming e After you have attached a new sterile pen needle on the cartridge holder and have removed the outer and inner cap you need to prime the pen needle e Hold the pen with the needle facing upwards e Press repeatedly until a drop of insulin appears at the needle tip e After you primed the pen press CACT to proceed e The screen will now display the pre programmed dose of the time segment you are in e If you would like to inject more or less than your time segment dose adjust the number of units by using or If you would like to proceed with the injection of your pre programmed dose insert the pen needle into your injection site using the injection technique recommended by your healthcare professional and press ACT to start the injection 43 44 9 Description of alarm signals on the display A Battery symbols When the battery is low the battery image flashes and then the screen turns off itself When the battery is empty the LED light flashes red 3 times and you hear an acoustic signal The LCD screen turns itself off and won t turn itself on again
10. the process of driving the plunger forward The plunger will stop when it hits the end of the cartridge e The remaining amount of insulin will be displayed on the home screen driving forward In case the screen turned itself off while you changed the cartridge follow the steps below to drive plunger forward e Press CACT and hold for Ssec to turn on the home screen When the plunger is completely rewound the display will show more than 300 0U example home screen 31 3e 6 3 Driving the plunger forward example remaining units Press M 4x e The display will show four bars L 1 e Press and the priming sign lt 1 will appear e Hold for 2sec to start the priming process e When the plunger starts moving let go of the button e Now the plunger will slowly move towards the cartridge and it will stop when the piston rod foot hits the end of the cartridge e The remaining units will be shown on the home screen Z Dose memory 7 1 Reviewing your last injection time amp units The pen is designed to prevent the risk of double dosages Therefore your last dose is always displayed when you enter injection mode To check your last injection press ACT once Now the last injection is displayed on the LCD screen with the time and the amount of insulin delivered alternating e g time of your last injection e g dose of your last injection Press M to return to home
11. until the battery is charged When the pen needle is blocked the X on the display flashes Also the LED light flashes red and you hear an acoustic signal beep If the residual amount is less than 20 0U the insulin cartridge image flashes When the bell symbol is displayed on the home screen the alarm sounds are turned on 10 Alarm sounds on off e Press CACT and hold over Ssec to turn on the home screen e The remaining amount of insulin is displayed on the home screen e Press MI 7x to enter alarm sounds settings The display will show the word bell e Choose with C or C the alarm sound setting D mugg alarm sounds on alarm sounds off home screen with alarm on e Press ACT to confirm When the alarm sounds are turned on the bell symbol is displayed on the home screen The alarm sounds are optional so that the diabetic has the possibility to inject insulin discreetly in public places But it is recommended not to let the alarm sounds be turned off all the time as important alarm sounds E e g for a pen needle blockage will be also muted When you choose to turn off the alarm sound please pay extra attention to the alarm signals of the LED light on the pen body 45 11 Charging the battery If the LED light of the pendig does not show a green light while your pen is recharging you have to check the B USB cable connection 11 1 Charging the battery using the USB cable e
12. al information Page 62 1 Introduction The digital insulin pen pendig is designed to deliver insulin for the insulin required diabetes mellitus With this pen you can adjust every dose up to increments as small as 0 1 U 0 001ml and with the memory function you can review your injection history with the date time and amount of insulin delivered This manual gives you instructions on how to use and maintain your pen You should read and follow the instructions carefully before you start using the pen Please keep this manual for your reference and register online on our website www pendiq com Other languages Please check out our website www pendiq com for a download of this user manual in other languages 2 Safety Instructions Important information for the safe use of the pendiq pen e Compatibility The pendiq pen is only suitable for the use of 3ml insulin cartridges 300 Units U 100 Insulin of the manufacturers Lilly Sanofi Aventis and Berlin Chemie Insulin cartridges from manufacturers other than the stated manufacturers are not suitable for the pendiq pen and may not be used The intended functionality of the pendiq is not secured when using insulin cartridges that are not adequate for the pendiq e The manufacturer is not responsible for the safety dosage accuracy and functionality as well as any damage caused by the usage of insulin cartridges that are not adequate for the pendiq e Before using you
13. at the same time in order for the button to click into place Never forcibly try to turn the pen 12 Manual injection mode e Close rubber lid The pendig is now converted back to digital mode You can check if the pen is switched back to digital mode by trying to turn the pen If you cannot turn it the pen is converted to digital mode but never forcibly try to turn the pen Charge the battery as soon as possible Even when the battery is empty and the pen won t turn back on your dose memory is never lost Your dose history is still saved on the pen even when the battery was empty and the pen was turned off The manual injection mode was designed for emergencies In manual injection mode pendiq does not register the delivered doses nor recognises the amount of insulin delivered Therefore the plunger of the pen needs to be rewound and afterwards driven forward again so the pen can recognize the new amount of insulin remaining in the cartridge After using manual injection the displayed residual amount of insulin may differ from the real amount delivered To see a demonstration of the manual injection mode please visit the following website www pendiq com usermanual 54 13 Cleaning and storage of the pen Do not use water when cleaning the pendiq Do not immerse the pen in water or any liquids Do not use any chemicals or liquid materials to clean the pen Incorrect cleaning and dirt may damage the pen
14. e e The remaining units willbe shown on the home screen example remaining units Now your pendig is ready for injection 21 Injection The screen must be turned on for at least 60 seconds while you operate in the injecting mode Health care professional strongly recommend using a new pen needle for every injection When a pen needle is used several times the medicine flow cannot be guaranteed as the pen needle may block This leads to the injection of an incorrect dose pendig recognizes when the medicine flow is affected and will signalise a blockage by showing a flashing cross X on the screen and a flashing red LED light Additionally you will hear an acoustic signal 5 1 Attaching the pen needle If you use longer acting NPH Basal insulin you need to stir the insulin by turning the pen up and down at least 10x as per cartridge instructions before you attach the pen needle Please read the patient information sheet of the insulin manufacturer e Take a new pen needle and remove the protective seal e Attach the needle by firmly screwing it onto the threads at the end of the cartridge holder e Remove the outer protective cap and the inner needle cap from the needle 5 2 Priming Press and hold CACT for Ssec to turn on the home screen The remaining amount of insulin is displayed on the screen Press ACT to start injection mode When you use pendiq for the first time no injection is saved on the pe
15. emperature 10 40 C 14 F 104 F Humidity 10 90 RH Atmospheric Pressure 660 1060 mbar Temperature O 40 C 32 F 104 F Humidity 20 70 RH Atmospheric Pressure 660 1060 mbar 2 years 7 days Class Il equipment with internally powered equipment Type BF applied part IPXO no special protection Continuous operation Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide EN 60601 1 58 15 2 Factory settings Maximum pressure Blockage pressure Allowable maximum volume per 1 time Allowable minimum volume per 1 time Injection rate Display turns itself off when no button is pressed after To turn on screen press ACT button for Countdown after injection Dosage increments Display of units in Cartridge volume 1 5 kg cm 1 0 kg cm 60 0 U 0 5U 2 0 U sec 60 seconds 3 seconds 15 seconds 0 1U U 0 01 ml 3ml 300 0 U x Apart from charging the battery no maintenance or services as well as no calibration of the measuring function E are required The change of a cartridge is explained in chapter 6 of this manual 59 15 9 The List of Icons SN Serial number Class II equipment naal Manufacturer Type BF applied part REF Reference number Appointed agent in the EC Protect from humidity Direct Current Electromagnetic compatibility IEC 60601 2 24 Material classification only GER 1 e N am Spec
16. end Intelligent insulin pen pendiq User Manual English Table of Contents Introduction Page 4 Safety instructions Page 5 About pendig Page 10 3 1 Contents of the package 3 2 Components 3 3 Operation buttons 3 4 Display symbols Getting started with your pendiq Page 14 4 1 Date and time setting 4 2 Extension disc for Lilly and Berlin Chemie cartridges only 4 3 Inserting the cartridge 4 4 Cartridge setting 4 5 Driving the plunger forward Injection Page 22 5 1 Attaching the pen needle 5 2 Priming 5 3 Setting your dose 5 4 Injecting your dose 5 5 Handling of the pen after the injection Changing the cartridge Page 28 6 1 Rewinding 6 2 Changing 6 3 Driving the plunger forward 7 Dose memory Page 33 11 Charging the battery Page 46 7 1 Reviewing the last injection time amp units 11 1 Charging the battery using the USB cable 7 2 Total dose 11 2 Using the USB cable for the transfer of data 7 3 Injection memory 12 Manual injection mode Page 48 8 Pre programming injections Page 37 13 Cleaning and storage of your pen Page 54 8 1 Programming time segments 14 Problems Page 55 8 2 Changing number of time segments 8 3 Injecting a time segment dose 15 Specifications Page 57 15 1 Technical information 15 2 Factory settings 9 Description of alarm signals Page 44 15 3 Descriptions of technical symbols 10 Alarm sounds on off Page 45 16 Product warranty Page 61 17 Gener
17. f driving the plunger forward until a stream of insulin is ejected from the needle STOP the process by pressing M in order to avoid the loss of too much insulin It is possible that a small air bubble may remain in the cartridge Repeat the priming process in the injection mode until a drop of insulin appears at the needle tip Change the pen needle Check the medicine flow again until a drop of insulin appears at the needle tip DO 14 Problems The pen has run out of bat tery I am unable to attach the extension disc to the plunger Do I really need the extension disc would like to adjust the amount of insulin delivered when priming After inserting a new cartridge and priming the pen my display shows less than 300 0U Does this mean there is less than 300 0U insulin in the cartridge The battery is rechargeable Please read the chapter Charging the battery and make sure that the battery is always well charged manual injection mode is only for emergencies Yes you always need the extension disc for Lilly and Berlin Chemie cartridges because it extends the plunger and makes Sure that you will receive the full amount of 300 0 U After 300 0 U have been used there is usually a small amount of insulin left in the cartridge The patient always receives the full amount of 300 0U with each cartridge even if there is some insulin left The fixed amount for priming is 0 5U and cannot be changed or decreased Each
18. has no OFF button The screen turns itself off after 60 seconds when no button is pressed When going through the menu with the M button you can always return to the home screen by pressing ACT 4 1 Date amp time setting e Press CACT and hold for Ssec to turn on the display e The LCD screen now displays the home screen When no cartridge is inserted and the plunger is completely rewound the display will show more than 300 0 U as e g beside Oloueo home screen Press MI once and then press the or button The year setting will appear as shown beside The last two digits of the year will flash e Adjust the year by pressing or and press CACT to confirm year 14 4 1 Date amp time setting e The screen will then display the date and month setting as shown beside First the digits for the day setting will flash e Adjust the number by pressing or and press LACT to confirm e Now the last two digits for the month setting will flash Adjust the number by pressing the C or C buttons and confirm with the CAG T button Next the time setting screen will appear as shown beside The time format is 24h e First the digits for the hour setting will flash e Adjust the number by pressing or J and confirm with the CACT button Now the last two digits for the minute setting will flash e Adjust the number by pressing or and press LACT to confirm
19. ific references regarding storage and or handling L Disposal note only EU we w The date of manufacture li Attention consult accompanying documents C 0120 CE certificate number 60 16 Product warranty The statutory warranties shall apply to this product You are entitled to warranty rights in accordance with the statutory provisions for a period of two years beginning with the date of purchase After your purchase of the pendigq we recommend to register online on our website www pendiq com or to fill out the registration card enclosed and return it to us In the unlikely event of failure during the two years of warranty please fill out the warranty card contained in the product box and send it together with the damaged or defective pendiq to the following address pendiq GmbH Customer service Baerler Strasse 100 47441 Moers Germany Please state the reason of your reclamation on the warranty card The pens send back to us will be recycled after the inspection according to legal regulations The manufacturer is not responsible for damages caused by the use of un suitable insulin cartridges or pen needles and for any inappropriate usage of the pendiq 51 62 17 General information Manufacturer Diamesco Co Ltd Migun Techno World Il 305 533 1 Yongsan dong Yuseong gu Daejeon 305 500 Korea Tel 82 70 8672 6410 Fax 82 70 8650 6405 diamesco naver com www diamesco com Sales in the EU No
20. ir bubbles insert the pen needle into your injection site using the injection technique recommended by your healthcare professional e Hold the pen firmly with your fingers between the dose ring and the cartridge holder e Hold the pen still e Turn the pen body where the display is with your free hand e The pen can only be turned in one direction You will notice the correct direction due to the clicking sound e Never forcibly turn the other direction as it may damage the pen e Each dimple on the dose ring represents 1 0U and you will hear a clicking sound for each turn Count the clicks until you have delivered your required dose 12 Manual injection mode e After you have delivered your required dose count to 15 and remove the needle from the injection site Hold the pen with your fingers between the dose ring and the cartridge holder while you reattach the protective outer needle cap and remove the needle If you hold the pen at the pen body the pen will turn itself while I unscrewing the needle and insulin will be ejected You will notice due to the clicking sound see page 49 e Safely dispose pen needle according to general safety rules e To switch the pen back to digital mode push the rubber lid back at the raised edge and push the red switch as illustrated above As the button is always blocked after manual injection mode you will need to turn the pen body clockwise while pushing the button up
21. n yet and the display will show the priming screen priming After you have used pendiq once the display will show you the last dose delivered alternating between the time and the units last delivered Confirm the last injection with ACT and the priming sign will appear e g time of your last injection e g dose of your last injection eg 5 2 Priming e Hold the pen with the needle pointing up in order to raise any air bubbles e Press until you see a drop of insulin at the tip of the needle e Each time you press 0 5 U will be ejected from the needle priming In case the insulin is not ejected through the needle tip even though you repeatedly press to remove air the pen needle may be blocked In case of a blockage the display will show a flashing and the LED light will flash u red Additionally you will hear an acoustic signal Use a new pen needle and repeatedly remove the air until a drop of insulin appears at the needle tip If you want to cancel the operation and move to the home screen press M 24 9 9 Setting your dose e Press ACT when a drop of insulin has appeared at the needle tip When you use the pen for the first time the display will show 1 OU After the first use the display will either display the units that were last delivered or the dose of a pre programmed injection See Chapter 8 I Adjust the required dose with the or C buttons more e When you pres
22. r pendiq you should consult your healthcare professional and read this important information carefully The manufacturer is not responsible for any problem or damage caused by not following the instructions e Consult your healthcare professional if you encounter abnormal blood glucose levels e The pen is not designed for the blind or visually impaired without a trained assistant e Before using the pen for the first time check that the date and time is set correct 2 Safety Instructions e For safety reasons it is recommended not to let the alarm sounds be turned off constantly as important alarm sounds e g blockage are also muted e Always make sure that the pen body and the cartridge holder are firmly screwed together before the injection e Always make sure that the pen needle is removed from the cartridge holder before priming e Never insert a used or previously inserted cartridge into the cartridge holder e Always make sure that there are enough units left for your dose e In case your pen is lost or damaged always carry an extra medicine delivery device and extra medicine e Before the injection you should check if you have inserted the correct insulin type as prescribed by your healthcare professional e Always remove possible air bubbles before each injection by producing a drop of insulin appearing at the needle tip e Do not share this pen with other people to prevent infection 2 Safety Instructions If you req
23. raised edge Pull up the end of rubber lid Switch to manual mode by pushing the red button down as described below Manual injection mode red switch towards the display Digital injection mode red switch towards cartridge holder Close the rubber lid 48 12 Manual injection mode 5 Screw pen needle onto cartridge holder holding the pen with your fingers between the dose ring and the pen body If you hold the pen at the pen body the pen will turn I itself while screwing on the needle and insulin will be ejected You will notice due to the clicking sound 12 Manual injection mode Once you have screwed on the pen needle you will need to remove any air bubbles e Hold the pen with the pen needle facing upwards e Hold the pen with your fingers between the dose ring and the cartridge holder e Turn the pen body with the free hand until a drop of insulin appears at the needle tip The pen can only be turned in one direction You will notice the correct direction due to clicking sound e Never forcibly turn the other direction as it may damage the pen e If you cannot turn the pen body check if the pen has been switched to manual mode correctly In digital mode you cannot turn the pen body e Each dimple on the dose ring represents 1 0 unit e You hear a clicking sound for each dimple Each click signalises the delivery of 1 0 unit 12 Manual injection mode When you have removed possible a
24. rway Switzerland Turkey and the Middle East pendiq GmbH Baerler Strasse 100 47441 Moers Germany Tel 49 0 2841 79 90 90 Fax 49 0 2841 79 90 98 info pendiq com www pendiq com excluding Sweden France Hungary Bulgaria Poland Estonia Lithuania Latvia 17 General information pendigq meets the requirements of the standards of IEC 60601 2 24 and ISO 13485 pendid is a registered trademark of pendiq GmbH Lilly is a registered trademark of Eli Lilly and Company Berlin Chemie is a registered trademark of the Berlin Chemie AG Sanofi Aventis is a registered trademark of the sanofi aventis group All trademarks are acknowledged PZN 9519620 Shadow black black PZN 9519637 Cool silver silver PZN 9519643 Arctic white white PZN 9519672 Lime green green PZN 9519666 Funky orange orange CE 0120 The CE marking indicates that the product has been subject to an assessment of his conformity with the MDD and that the medical device fulfills the requirements of the Medical Device Directive 93 42 EEC Please check our website www pendiq com or www diamesco com for an updated issue of this manual since issued in February 2012 Technical changes reserved Rev 90100 2012 02 63 pendiq mbH Baerler StraBe 100 Tel 49 O 28 41 79 90 90 47441 Moers Fax 49 O 28 41 79 90 98 Germany Mail info pendiq com www pendiq com
25. s or the number will be increased decreased by 0 1U e When you press and hold or each time it will be increased decreased by 1 0 U Although pendig can deliver doses as small as 0 1U the recommended minimum amount for each dose is 0 5 U The maximum amount for one dose is 60 0 U When you have reached the number 60 the red LED light will flash to inform you that you have reached the maximum dose limit You can cancel the setting of your dose at any time by pressing M and return to the home screen When you have set the required dose you will need to inject it 25 5 4 Injecting your dose The number of units for your dose is now displayed on your LCD screen e Firmly hold your pen and insert the needle to your injection site using the injection technique recommended by your healthcare professional e Press CACT to start the injection process The number on the display will now decrease to 0 0 e During injection the LED light on the pen flashes green e Afterwards the pen will now count down from 15 to O seconds This is how long it is recommended to keep the needle inserted in the injection area e After the 15 second countdown the screen will show the sign End on the display e The green light will flash 3x and you hear 4x a short acoustic signal 2 6 5 4 Injecting your dose e Now you can withdraw the pen needle from your injection site e After the injection the remaining amount of insulin
26. s automatically with the starting time of the next time segment 06 00 a m flashing e The right side of the screen will now show you the dose amount you need to adjust e Adjust units by pressing and When you have chosen the required dose for the time segment press CACT to confirm time segment example dose amount for the time segment flashing 39 8 1 Programming time segments Set the starting time and dose for the next time segments as previously explained and confirm settings with ACT example next time segments bipuad bipuad uma m r Lot starting time flashing dose flashing starting time flashing dose flashing kam i x Pe Br After you have confirmed the dose amount for the last time segment the display will return to the home screen example home screen 40 8 1 Programming time segments You can program up to 9 time segments The following illustration will give you an example of pre programmed time segments The starting time of a time segment is automatically the ending time of the previous time segment These are only examples of pre programmed time segments The time segments programmed will automatically be repeated every 24 hours unless the pre programmed mode is deactivated If you want to deactivate the pre programmed time segments choose time segment O in time segment settings and confirm wi
27. screen 33 7 2 Total dose e Press and hold CACT for Ssec to turn on the home screen example home screen e Press MI once to see present time example present time e Press MI once more to see the total of units delivered today example total dose 34 7 9 Injection memory e When the home screen is displayed press M 3x to see your injection memory e The display will now show the last dose delivered alternating between the date time and units of the last dose e g below time dose date e Press to go back in dose history and review other previous doses e Each time you press the memory will go back one injection e The screen will alternate between date time and units of the dose e Press to go forward in dose history 35 7 9 Injection memory e Press CACT to return to the home screen example home screen pendiq greatest benefit is to save the last 195 injections with date time and amount of units delivered When you exceed 195 injections the first injections will be deleted from the memory as the pen cannot store more than 195 injections Please make sure that you transfer the memory regularly to your diabetes management software When you transfer the injection history to the software pendiq will not delete the data on the pen but always keep the last 195 injections saved 35 SO Pre programming injections Pre programming means that you can pre program a
28. th CACT To review your time segment settings at any time press M 6x and enter the pre programming setting with CACT Use the ACT button to review and confirm your pre programmed time segments 41 8 2 Change number of time segments To change the number of time segments you have programmed previously you will have to return to time segment setting Starting from the home screen press M Gx The display will show you how many time segments are programmed so far e Press LACT to enter time segment setting The time segment number will now flash e Choose new number of time segments by pressing or and confirm with CACT e Set starting time and dose for the time segments as previously explained and confirm settings with CAC T e After you have confirmed the dose amount for the last time segment the display will return to the home screen If you would like to cancel the starting time or dose setting of a time segment press Mi The display will then return to the time segment screen Now you can choose again how many time segments you would like to program If you want to reset the preprogrammed time segments and therewith turn off the preprogramming mode press MI The time segment number will change to zero To confirm the reset press ACT To cancel and return to home screen press M 4 2 8 9 Injecting time segment dose During a time segment the pre programmed dose for a time
29. time is pressed 0 5U are delivered No The motor driven plunger foot of the pendiq applies more pressure on the rubber plunger of the insulin cartridge than the plunger of traditional pens Due to the elasticity of the rubber plunger of the insulin cartridges the remaining amount of insulin displayed may vary slightly This does not mean that there are less than 300 0U in the cartridge For further information visit our website www pendiq com and check our FAQs 15 Specification 15 1 Technical information Product name Manufacturer Length Weight Infusion rate Cartridge Storage Volume Increments Dosage range per Injection Battery Memory Alarm Acoustic signals Data transfer pendiq Diamesco Co Ltd Daejeon 305 500 Korea 182mm 46g without insulin cartridge and pen needle 2 0U sec 3ml 800 0U 0 1U 0 5 60 0U 3 7V 90MAh Lithium lon Polymer battery rechargeable up to 300x 80 capacity 195 last injections date time and amount delivered low battery blockage low residual amount of insulin in the cartridge 20 0 U or lower end of injection alarm sounds on off optional data transfer through USB 15 1 Technical information USB Current Rating Storage Operating conditions Warranty Duration of battery Type of protection against electric shock Degree of protection against electric shock Degree of protection against the ingress of water Mode of operation USB 5V 500mAh T
30. uire the assistance of another person for the injection please pay extra attention when handling the pen as the pen needle may injure you or your assistant and may lead to infections Do not modify or disassemble the pen Do not use the pen if any part of your pen looks broken or damaged Contact your local supplier or your healthcare professional For safety reasons a damaged pendiq may not be used Do not pull out the USB lid or manual switch lid by force Always use a new sterile pen needle Health care professionals strongly recommend not reusing a pen needle Using a new needle for each injection will minimize the risk of infections and a pen needle blockage The inserted insulin cartridge and the cartridge manufacturer in the settings must match If they don t match the pen cannot recognize the exact residual amount of insulin in the cartridge and the amount of units displayed may then differ from the real residual amount This can result in the injection of an incorrect dose 2 Safety Instructions Do not keep the needle attached to the pen after the injection Always safely withdraw and dispose the used needle Always follow general safety measures for the removal and disposal of needles in order to minimize the risk of unintended needle penetration and transmission of infectious diseases Otherwise it may cause incorrect insulin delivery leakage of insulin and unintended needle injury etc Do not expose the pendiq to moist
31. ure pendiq is not water proof and holds no protection against the ingress of water or moisture When exposed to water or moisture the pen may suffer damages and not function properly Do not store in the refrigerator Do not use water when cleaning the pendig Do not immerse the pen in water Do not throw or drop your pen on purpose as shocks and impacts may damage the pen Keep away from heat and do not expose the pen to direct sunlight When exposed to heat the pen may suffer damages and not function properly 2 Safety Instructions Always make sure that the battery of the pen is well charged It is recommended to fully charge the battery as often as possible to extend the duration of battery life Manual injection mode is only for emergencies To avoid potential problems do not use the manual injection mode while the pen works normally When using the manual injection mode only turn your pen in the direction as described in the manual After using the manual injection mode please rewind your pen and drive the plunger forward afterwards Keep away from electronic equipment including electromagnetic waves or frequency pendiq may suffer damages when exposed to electromagnetic waves Keep away from flammables and do not use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide The pendiq pen is also suitable for domestic use 10 3 About pendia 3 1 Contents of the package Check
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