Accu-Chek Spirit Combo insulin pump—User's Manual

Overview of ADVANCED user menuOverview of STANDARD and CUSTOM user menusYour contact for assistance with and/or additional information aboutyour Accu-Chek Spirit Combo insulin pump:j j Press d to move forwardsjjPress d + a simultaneouslyto move backwardsjjPress f to select or savejjPress a to go upjjPress s to go downBRP = Basal Rate Profile 2–4BRP 4BRP 3BRP 2RUNffSTOPBRP 4BRP 3BRP 2Accessible menus in CUSTOM usermenu can be selected usingAccu-Chek PC software (soldseparately).j j Press d to move forwardsjjPress d + a simultaneouslyto move backwardsjjPress f to select or savejjPress a for upjjPress s for down= not accessible in STANDARDuser menuRUNffSTOPUnited Kingdom:Roche Diagnostics Ltd.Charles AvenueBurgess Hill, West SussexRH15 9RY, EnglandPhone +44 1444 256 000Pump Care Line:UK: 0800 731 22 91 / IRELAND: 1800 88 23 51burgesshill.insulinpumps@roche.comwww.accu-chek.co.uk/insulinpumpsAustralia:Roche Diagnostics Australia Pty. Ltd.31 Victoria AvenueCastle HillNSW 2154, AustraliaPhone 1800 633 457 (Pump Hotline)1800 802 409 (Orders)Fax 1800 066 598 (Orders)sydney.accu-chekextra@roche.comwww.accu-chek.com.auNew Zealand:Roche Diagnostics N.Z. Ltd.P.O. Box 62-08915 Rakino WayMt. Wellington, Auckland 1641New ZealandAccu-Chek Enquiry Line: 0800 80 22 99Phone +64 9 276 4157Fax +64 9 276 8917info@accu-chek.co.nzwww.accu-chek.co.nzSouth Africa:Roche Products (Pty) Ltd.Diagnostics DivisionP.O. Box 1927, Randburg 21259 Will Scarlet RoadRandburgSouth AfricaPhone +27 11 504 4600Fax +27 11 781 0269www.diabetes.co.zaIndia:Roche Diagnostics India Pvt. Ltd.Plot no:114, Road no.15MIDC, Andheri (East)Mumbai – 400 093IndiaTel.: + 91 (22) 6697 4900Fax.:+ 91 (22) 6697 4909www.roche-diagnostics.co.inCanada:Roche Insulin Delivery Systems Inc.11800 Exit 5 Parkway, Suite 120Fishers, IN 46037, USAToll Free 1-800-280-7801info.insulindelivery@roche.comwww.accu-chek.comSingapore:Roche Diagnostics Asia Pacifc Pte Ltd.298 Tiong Bahru Road11-01/06 Central Plaza168730 SingaporePhone +65 6 272 92 00Fax +65 6 371 65 00accu-chek.sg@roche.com

About this User GuideTo ensure safe and convenient use of your new Accu-ChekSpirit Combo insulin pump, some information in this User Guiderequires particular attention. This information is presented as“Warning”, “Caution” or “Note”.jj A “Warning” informs you about risks to your health. Neglectingthis information may even lead to life-threatening situations insome cases.jj A “Caution” informs you about risks to your device. Malfunctionor damage may result if you do not follow these instructions.jj A “Note” contains important information relating the efficientand smooth operation of your new Accu-Chek Spirit Comboinsulin pump.

1 Understanding your new system 71.1 Overview 71.2 Display and sounds 91.3 Keys and key combinations 151.4 Accessories and disposables 191.5 Emergency kit 221.6 General safety information 232 Getting started 252.1 Before you begin 252.2 Inserting the battery 252.3 Start-up process 292.4 Setting the time and date 322.5 Your basal rate profile 352.6 Connecting the cartridge, adapter and infusion set 422.7 Inserting the cartridge 442.8 Priming the infusion set 492.9 Positioning the infusion set 522.10 Starting insulin delivery 552.11 Stopping insulin delivery 562.12 General safety information 573 Using your pump in daily life 613.1 Wearing your pump 613.2 Interruption of insulin pump therapy 643.3 Your insulin pump and water 673.4 Changing the infusion set 693.5 Changing the cartridge and infusion set 733.6 General safety information 764 Boluses and Temporary Basal Rates 774.1 Understanding boluses 774.2 Programming a Standard Bolus 784.3 Programming an Extended Bolus 844.4 Programming a Multiwave Bolus 894.5 Programming a Temporary Basal Rate (TBR) 934.6 General safety information 985 Personalizing your pump 995.1 Introduction 995.2 Selecting a user menu 1015.3 Standard user menu 1035.4 Viewing your pump data 1055.5 Transferring your data to a computer 1115.6 Pump settings 1135.7 ADVANCED user menu 1205.8 Basal rate profiles 1215.9 Setting a Reminder 1245.10 Therapy settings 1265.11 CUSTOM user menu 1305

6 Using the Accu-Chek Spirit Combo insulinpump with the Meter 1336.1 Meter 1336.2 Switching Bluetooth ® ON and OFF 1356.3 Pairing your pump with the Meter 1366.4 Troubleshooting the Bluetooth ® connection 1397 Care and Maintenance 1437.1 Inspecting your pump 1437.2 Damage to your pump 1457.3 Your insulin pump and water 1467.4 Repair of your pump 1487.5 Maintaining your pump 1497.6 Storing your pump 1507.7 Disposing of your pump 150Appendix A: Technical Data 175Appendix B: Configuration parameters 189Appendix C: Sterile products and accessories 192Appendix D: Abbreviations 194Appendix E: Beeps and melodies 195Appendix F: Symbols 201Appendix G: Warranty 207Glossary 208Index 213Quick reference table for Errors, Warnings and Reminders 218Reminder 220My notes 221Bluetooth ® registration 2228 Warnings and Errors 1518.1 Confirming a Warning or Error 1528.2 List of Warnings 1538.3 List of Errors 1598.4 List of Reminders 17069 Troubleshooting 1719.1 Therapy-related issues 172

11 Understanding your new system1.1 OverviewYour Accu-Chek Spirit Combo insulin pump has many helpfulfeatures that help to ensure safe and efficient pump therapy.NoteIn this User Guide the term “Meter” always refers to theAccu-Chek Aviva Combo Blood Glucose Meter orAccu-Chek Performa Combo Blood Glucose Meter*.1.1.1 Summary of featuresThree user menusYour Accu-Chek Spirit Combo insulin pump has been designed toadapt to your level of experience in pump therapy – whether youare a beginner or an experienced pump user. Your pump “grows”with you!You can use one of 3 menus – STANDARD, ADVANCED orCUSTOM – to access the functions and settings you will needfrom day to day.Interaction with the MeterThe Accu-Chek Spirit Combo insulin pump is designed for usewith the Meter. This new product is an intelligent blood glucosemeter that can remote control the pump using Bluetooth ®wireless technology.* The Accu-Chek Performa Combo Blood Glucose Meter has not been licensedfor sale in Canada.7

STANDARDADVANCEDCUSTOMThis is the most basic menu – designed forsimplicity and comfort.This menu helps you to adjust your therapyto a wider range of situations.The CUSTOM menu enables you tofine-tune your pump according to yourpersonal needs and skill level.See chapter 5 Personalizing your pump.Five basal rate profilesYou can choose from 5 basal rate profiles, in line with yourdifferent daily routines.Four bolus typesYour Accu-Chek Spirit Combo insulin pump enables you to program4 bolus types, each corresponding to different situations youmay encounter, and this provides you with a lot of flexibility.Quick BolusYou can program a Quick Bolus without looking at the displayscreen and check that it is correctly programmed by counting thebeeps and vibrations. This is particularly useful when you wantto program the bolus discreetly in public.Dual signalling of Warnings and ErrorsFor your safety, Warnings and Errors are signalled using bothaudible beeps and vibration of the pump. In addition, the beeptones are fully adjustable – from silent to loud.Data transferThe infrared port on the bottom of your Accu-Chek Spirit Comboinsulin pump enables you to transfer information between yourpump and a personal computer or handheld device.Rotating displayYour pump’s display can be rotated through 180 degrees, andyou can also adjust its contrast. Combined with the backlight,these features make the display easier to read.8

ReminderAs well as Warnings and Errors, your pump can signal Reminders.This works like an electronic alarm clock.Choice of batteriesYour Accu-Chek Spirit Combo insulin pump can be powered byeither disposable or rechargeable batteries. (If you decide to userechargeable batteries, you will need a battery charger recommendedby the battery manufacturer.)KeylockThe Keylock feature allows you to lock all 4 keys on your pump toprevent the accidental activation of functions. For example, youcan use Keylock while you are asleep or when playing sports.1.2 Display and soundsYour Accu-Chek Spirit Combo insulin pump has a Liquid CrystalDisplay (LCD) screen. This display, together with the 4 keys,enables you to program the pump. It also shows importantinformation about the status of your pump.w WarningChanges in the status of your pump can be life-threatening. Iffor any reason you cannot hear the audible signals or feel thevibrations of your pump, looking at the display is the only waythat you will be aware of changes or malfunctions in yourpump.19

The RUN screen also displays Reminder information (such as“cartridge low”) and special functions (such as Keylock – lockedor unlocked) in the form of symbols. (See Appendix F: Symbols)NoteAfter you program or review information, the pumpreturns to the RUN screen.STOP screenThe STOP screen is displayed when the pump is in STOP mode.This means that insulin is no longer being delivered to your body.The STOP screen shows the current time and date, and the STOPsymbol.TimeDateKeylock unlockedThe STOP screen also displays Reminder information (such as“battery low”) and special functions (such as Keylock – locked orunlocked) in the form of symbols.Your pump must be in STOP mode in the following situations:You arejj programming specific functionsjj changing the cartridge and / or the infusion setjjpriming the infusion setjjtransferring data to or from the pumpjj changing the batteryQuick Info menuYou display the QUICK INFO screen by pressing the f key whilein RUN or STOP mode. The QUICK INFO screen shows theremaining insulin content of the cartridge in units.Pump timerCartridge lowBattery low12

1By pressing f again you enter the BOLUS DATA function. Youcan view the last 30 boluses by pressing a or s.You can leave the Quick Info screen either pressing f againor pressing no key for 20 seconds.Information, Function and Set-up screensYou access these screens when you program the pump, performa function, change a setting, or store or transfer information. Youcan reach these screens from either the RUN or STOP screen.1.2.4 Navigating through the screensThe following procedure explains how to navigate throughthe screens. Think of these screens as menu choices. Seesection 1.2.3 Display screens.1. Press the d key to select a screen of your choice.2. Press the d key again to see the next available choice inthe menu. (After you reach the last menu choice, you willreturn to the first menu choice.)3. When you reach the screen of your choice, press thef button.The next set of screens are called Function screens, and allrelate to the choice you have just made. There may be one orseveral Function screens.4. Press the s or a key to increase or decrease thedisplayed value, or press the d key again to move to thenext Function screen to make further changes. (After youreach the last Function screen, you will return to the firstFunction screen.)5. Press the f button to save your changes.13

You can move backwards through the main menu screens bypressing the d key and a key simultaneously.In any sub-menu the same key combination will move you backto the main menu screen.NoteChanges that you made in the sub-menu will not besaved.1.2.5 Status messages and alarm signalsYour Accu-Chek Spirit Combo insulin pump informs you of thestatus of your pump using audible beeps, vibrations anddisplayed messages. It is vital that you be able to hear and / orfeel the beeps and vibrations. Be aware that some carryingpouches may hinder the perceptibility of the signals.You can turn off either beeps or vibrations, but for your safetyyou cannot turn off both at the same time for the initial alarmsignal.See chapter 8 Warnings and Errors for a description of the fullrange of Warnings and Errors.STOP-WarningThe STOP-Warning is triggered when your pump switches fromRUN mode to STOP mode, or when a battery is inserted. Thepump emits 2 beeps and vibrates once every minute. This warnsyou that insulin delivery has been interrupted.14

1To turn off the STOP-Warning, press either a or s for 3seconds. You then hear a melody, confirming that the STOP-Warning has been turned off. If you press the key too briefly, theSTOP-Warning will not be turned off.NoteFor your safety, the volume of the STOP-Warning cannotbe changed. It is independent of the programmed beepvolume.1.3 Keys and key combinationsYou use the 4 keys on the Accu-Chek Spirit Combo insulin pumpto program functions, access information, and set up the pump.Each time you press a key the pump will beep, unlessthe beep tone is set OFF.f OK keyd Menu keya Up keys Down key15

The following table lists the keys and their functions.Key Name Functiond Menu jj Move through menus, function screensand information screensf OK jj Select a menujj Save changes and exit the function andinformation screensjjView the Quick Info screena Up jjMove forward in the information screensjj Increase a settingjj Turn on the backlightjjProgram a Quick BolusjjCancel a Quick Bolusjj Turn off the STOP-Warning (press andhold 3 sec. until you hear a melody)Key Name Functions Down jjMove backward in the informationscreensjj Decrease a settingjjProgram a Quick BolusjjCancel a Quick Bolusjj Turn off the STOP-Warning (press andhold 3 sec. until you hear a melody)c CautionDo not press the keys with a sharp or pointed item such as thetip of your fingernail, as this could damage the casing of yourAccu-Chek Spirit Combo insulin pump. Instead, use the pad ofyour fingertip to avoid puncturing the keys.16

11.3.1 Combining keysYou can obtain additional functions by pressing 2 keyssimultaneously. In the following table, a plus symbol (+) indicatesthat both buttons must be pressed at the same time.w WarningIf the keys on your pump are not functioning properly,disconnect your pump and contact your local pump support(see inside back cover).Combinationd + ad + sa + sFunctionjj Exits menus, functionscreens and informationscreens without saving yourchanges.jj Moves you to a previousmenu.jj Unlocks the keys. Pressand hold both buttons untilyou hear 3 short beeps(RUN mode) or 3 long beeps(STOP mode).jjCopies an hourly basal rateto the following hour.17

1.3.2 ScrollingTo enter larger or smaller values, the a and s keys mustsometimes be pressed several times until the desired value isshown, with each press of the key changing the figure by a smallincrement. However, you can also press and hold the key(scrolling function) to change the value faster. When programmingboluses and hourly basal rates the increment of the valuechange increases if you keep the a or s key pressed.When you begin scrolling, the pump beeps once.1.3.3 Locking the keysThe Keylock feature enables you to lock all 4 keys on yourAccu-Chek Spirit Combo insulin pump. This is a valuable safetymeasure that prevents you from accidentally activating yourpump. For example, you can use Keylock while you are asleepor when playing sports.You turn on the Keylock function in the PUMP SETTINGS –See section 5.6 Pump settings.18

11.4 Accessories and disposablesHigh-quality sterile disposables and accessories are a vitalpart of the Accu-Chek Spirit Combo insulin pump system, andhelp to ensure safe pump therapy. Always follow the instructionsprovided by your doctor or healthcare team – as well as theprinted instructions included with the product – relating to theuse of these items.w WarningYour pump has been designed for use with U100 insulin. Onlyuse sterile disposables and accessories that are designed foruse with your Accu-Chek Spirit Combo insulin pump. Thecorrect functioning of your pump can only be guaranteed if youuse Accu-Chek brand sterile products and genuine Accu-ChekSpirit Combo insulin pump accessories.NoteUse your insulin pump, sterile disposables and accessoriesfor the first time in the presence of your doctor orhealthcare team.1.4.1 Sterile disposablesEach sterile disposable, such as cartridge or infusion set, shouldbe used only once, as re-using these products could lead toinfection or could damage your pump. Do not use a sterileproduct if the package has been damaged or opened.19

1.4.2 AdapterventsNote It is essential to change the adapter at least every 2months. You must also change the adapter if the sealsbecome worn, are lost, or if the vents are blocked.gripsealthreadThe adapter connects the cartridge to the infusion set, and alsokeeps the cartridge compartment watertight with 2 seals, oneinside and one outside the adapter. It holds the cartridge in placeand prevents the entry of air bubbles. The 2 small vents on theadapter allow air pressure to be equalized inside and outside thecartridge compartment. The adapter will not work properly if thevents are blocked or dirty, or if the seals are missing.1.4.3 BatteryYour pump requires one AA 1.5 V battery in order to function. UseAA high-quality alkaline LR6 or lithium FR6 batteries that have aminimum capacity of 2500 mAh. Do not use carbon zinc or nickelcadmium (NiCd) batteries.If you prefer, you can use rechargeable batteries – in this case,use AA 1.2 V NiMH HR6 batteries with a minimum capacity of2500 mAh. Always use a battery charger recommended by thebattery manufacturer. See Appendix A Technical Data p. 176.20

1c CautionUse of batteries other than those recommended may significantlyreduce battery usage time. Such batteries may alsoleak and corrode the battery contacts in your pump. Theycould also lead to an electronic short circuit resulting indangerous heat development. The use of batteries notsupplied or recommended by Roche may void the warranty.Before inserting rechargeable batteries make sure that theyare not damaged (e.g. damaged plastics isolation coating) orleaking as damaged or leaking batteries could damage yourpump.Battery keyThe battery key tightens and loosens the battery cover. It is alsodesigned to loosen the luer-lock connection between the infusionset and adapter if it cannot be loosened by hand, by using thenotch on the side. However, never use the battery key to attachor tighten an infusion set. Using the battery key preventspossible damage to the battery cover.If you lose the battery key, or if it becomes cracked or worn, ordera replacement immediately, rather than using makeshift tools.For a list of recommended accessories and disposables, seeAppendix C.NoteAlways remember to remove the battery if yourAccu-Chek Spirit Combo insulin pump is not going to beused for a long period, in order to conserve the battery.Battery coverThe battery cover seals the battery compartment, and must bechanged at least every 2 months. You must remove and replacethe battery cover using the battery key – do not use knives,screwdrivers or other sharp objects, as these may damage yourpump.21

1.5 Emergency kitIt is highly recommended to keep accessories and disposableswith you in case of an emergency. This enables you to changethese items if necessary. Such an emergency kit should contain:jj An Accu-Chek infusion setjj A new AA alkaline or lithium batteryjj An Accu-Chek Spirit 3.15 ml Cartridge Systemjj An insulin pen or syringe for alternative therapyjj A vial of insulinjjTreatment for low blood glucose levelsjj Blood glucose monitoring equipment(such as an Accu-Chek blood glucose meter)jj A disinfectant for skinjj A battery keyjj A battery coverjj An adapterw WarningMake sure that you have an alternative therapy plan, providedby your healthcare professional. Use this plan whenever youneed to interrupt pump therapy.22

11.6 General safety informationw WarningAlways make sure to accurately program your personal settingsto avoid inappropriate insulin delivery. This phrase means thateither too much or too little insulin is delivered. Too much insulincan lead to severe hypoglycaemia. Too little insulin can lead toa life-threatening ketoacidosis.w WarningYour insulin pump has not been tested with cardiac pacemakers.For information about the safe use of your Accu-ChekSpirit Combo insulin pump with a cardiac pacemaker, contactthe pacemaker manufacturer. For reference see Appendix ATables 201 – 205.c CautionIf you should drop your pump, immediately inspect it carefullyfor damage. Do not use your Accu-Chek Spirit Combo insulinpump if cracks or chips are visible – these may allow water,dust, insulin or other foreign substances to enter the pumpand lead to malfunction.23

22 Getting startedThis chapter explains how to prepare your pump and begininsulin pump therapy.2.1 Before you beginSuccessful insulin pump therapy requires you to check yourblood glucose levels frequently. It is therefore recommended thatyou use an Accu-Chek blood glucose meter as often as directedby your doctor or healthcare team (at least 4 times a day).Your Accu-Chek Spirit Combo insulin pump has been designedfor use with the Meter. This intelligent blood glucose meterenables communication with your pump using Bluetooth ®wireless technology.2.2 Inserting the batteryYour Accu-Chek Spirit Combo insulin pump turns on as soon asyou insert the battery. When you remove the battery, your pumpkeeps track of the time and date for about one hour. Your insulinpump settings (such as the hourly basal rates, bolus incrementand active user menu) and the event memory (bolus and alarmhistory, history of daily insulin totals and Temporary Basal Rates)are always saved, regardless of battery condition or the amountof time your pump has been without a battery. See section1.4.3 Battery for information on batteries (both disposable andrechargeable types).25

Procedure for inserting and changing the battery1.Press d to move to the STOP YOURPUMP screen.2.Remove or disconnect your infusion setfrom the infusion site, to ensure thatthere is no risk of accidental insulindelivery.Press f to select. Your pump is now inSTOP mode and insulin delivery stops.3.Remove the battery cover.Use the battery key to turn the batterycover anti-clockwise. Make sure that theopening of the battery compartment andthe seal are clean and undamaged.Where appropriate, remove the oldbattery.4.Insert the battery, negative (–) end first,positive (+) end up, into the compartment.26

25.6.Use the battery key to fully tighten thebattery cover. You can verify that thebattery cover is correctly tightened bychecking that it is in line with the pumpcasing. Do not over-tighten.Place the cover on the positive end andgently push the battery in, while turningthe cover clockwise to partially tighten it.After inserting the battery, the pump begins its start-up process(see section below).In case the pump does not begin the start-up process afterinserting the battery, make sure that the battery is insertedcorrectly (negative end first).27

c CautionTo prevent water from entering the pump casing, only insert orchange the battery in a dry environment. Make sure that thebattery cover seal is not worn or missing, and that the batteryis correctly inserted.NoteIf your pump was in RUN mode before you removed thebattery, the Error E8: POWER INTERRUPT will occur whenthe new battery is inserted. Press f twice to confirmand snooze the Error. Check the time and date andcorrect them if necessary. Then put your pump into RUNmode. See section 2.4 Setting the time and date.28

22.3 Start-up processYour pump runs a start-up process when you insert a battery orwhen you change the cartridge. During this process, your pumpperforms a series of internal tests.When you …change only thecartridgeThen …the start-up process begins at theSELF-TEST screen.When you …change the batteryThen …the whole start-up process isperformed.w WarningDo not interrupt the start-up process by pressing keys orotherwise handling the insulin pump. Interruption of theprocess may lead to malfunction of your pump.Start-up process sequence1. 2. 3.The software version screen appears. The Accu-Chek logo appears. The SELF-TEST screen appears.29

4. 5.w WarningThe BEEP TEST screen appears and yourpump beeps.Listen for the beeps.If you cannot hear the beeps from yourAccu-Chek Spirit Combo insulin pump,you may not be notified of changeswithin the pump in time to take action.If you do not hear the beeps, stopusing the pump and contact your localpump support. (See inside back cover)The VIBRATION TEST screen appears andyour pump vibrates.Check the vibrations.w WarningIf you cannot feel the vibrations, youmay not be notified of changes withinthe pump in time to take action. If youdo not feel the vibrations, do stopusing the pump and contact your localpump support. (See inside back cover)6. 7.The display then goes blank. Check thatthe display is empty. (The backlight turnson during this step.)The display then shows a pattern. Checkthat the pattern is even.30

28. 9. 10.The display turns black. Check that thedisplay is completely black.If your pump detects a Warning or anError during the start-up process, itsignals the Error or Warning at this point.See section 8.3 List of Errors.After the self-test, press a or s toselect the type of battery you inserted.Press f to save and exit.11.The end of the start-up process issignalled by a melody, and the pumpdisplays the STOP screen.The STOP-Warning occurs every minute.To turn the STOP-Warning off, press aor s until you hear a melody and / orfeel a vibration.When you use your pump for the firsttime or have not used it for a longer time,you will be guided automatically to theTIME AND DATE SETTINGS option afterstep 10 (see next page).c cautionMake sure that you choose the correctbattery type. Otherwise you may not beinformed about a low battery in time.31

2.4 Setting the time and dateIt is essential to set the time and date correctly, because basalrates and history information are stored on the basis of the timeand date set in the pump. When you travel across time zones,make sure that the time and date are re-set correctly.You can choose between American or European / Military time.American12-hour clockmonth / day / yearEuropean / Military24-hour clockday / month / yearw WarningIncorrect setting of the time and date can lead to incorrectbasal insulin delivery. Make sure that the time and date ofyour pump are set correctly, to ensure correct delivery anddata memory. Do not make therapy decisions based on asingle result in the pump’s memory.w WarningIn addition, if you, your doctor, or healthcare team arereviewing your data electronically, it is essential that yousynchronize the time and date of your pump with those ofyour blood glucose meter, your personal computer orhandheld device. Otherwise, the resulting data might not bemeaningful. Check these devices regularly to ensure that thesettings remain synchronized.32

2Procedure for setting the time and date1. 2. 3.Press d to move to the TIME AND DATESETTINGS screen.Press f to select.The HOUR screen is displayed.Press a or s to set the hour.Press d to move to the MINUTE screen.Press a or s to set the minute.4. 5. 6.Press d to move to the YEAR screen.Press a or s to set the year.Press d to move to the MONTH screen.Press a or s to set the month.Press d to move to the DAY screen.Press a or s to set the day.33

7.8.Press d to move to the TIME FORMATscreen.Press a or s to set the time format.Press d to move to the DATE FORMATscreen.Press a or s to set the date format.Press f to save and exit.34

22.5 Your basal rate profileYour Accu-Chek Spirit Combo insulin pump must be programmedwith your personal settings before you begin pump therapy. Yourdoctor or healthcare team can help you to understand how to usethe pump.NoteFor your safety and convenience during programming,your Accu-Chek Spirit Combo insulin pump switches toRUN or STOP screen if no key is pressed within 20 seconds.Any changes you have made before this “time-out”occurs will not be saved .2.5.1 Programming your basal rate profileYour Accu-Chek Spirit Combo insulin pump delivers insulin every3 minutes, in 20 equal doses every hour, 24 hours a day. Thisflow of insulin, measured in international units per hour (U / h),is called the basal rate profile and is calculated to meet yourbasic insulin needs.The pump can store up to 5 different basal rate profiles to matchyour changing insulin needs – for example: Monday to Friday,Exercise Day or Sleeping Late Day.An Accu-Chek Spirit Combo basal rate profile consists of up to24 different hourly basal rates. Each hourly rate may be changedindependently. The total of all 24 basal rates in one basal rateprofile is called the (daily) basal rate total.Example: Basal rate profile for 18 U / 24 hoursInsulin delivery[U / h] Hourly basal rate0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time35

Your basal rate profile should be reviewed:jj After any programming changes are made to your pumpjj After a new battery is insertedjjAfter confirming the Error E7: ELECTRONIC ERROR.NoteInsulin delivery does not stop or pause during basalrate programming.Procedure for programming your basal rate profile1. 2.3.Press d to move to the BASAL RATEPROGRAMMING 1 (2, 3, 4 or 5 accordingly)screen.Press f to select.The daily BASAL RATE TOTAL is displayed.Press d to move to the first hour.This is always 00:00 – 01:00(12 AM – 01 AM if the American timeformat is used).36

24. Note The increments shown depend on 5.the programmed basal rate: it willbe0.01 U from 0.05 U to 1.00 U,0.05 U from 1.00 U to 10.0 U andPress a or s or scroll to set thehourly basal rate given by your doctor orhealthcare team.0.1 U from 10.0 U to 50.0 UPress d to move to the next hour.6. 7.Continue using d and a or s to setthe hourly basal rates for the remaininghours. This allows you to program yourindividual basal rate profile on anhour-by-hour basis. Continue until all24 hours are programmed.Press f to confirm.The new daily BASAL RATE TOTAL isdisplayed.Press f to save the profile and exit.37

Copying an hourly basal rateIf your basal rate is the same for multiplehours in a row, you can save time bycopying an hourly basal rate to one ormore hours.1.Press d to move to the BASAL RATEPROGRAMMING 1 (2, 3, 4 or 5 accordingly)screen.2.Press f to select.The daily BASAL RATE TOTAL isdisplayed.3.4. 5.38Press d to move to the hourly basalrate you want to copy.Press a and s simultaneously.A special beep confirms that you arepressing the keys correctly. The samehourly basal rate is copied to the nexthour.If you want to copy the rate to multiplehours, press a and s repeatedly orpress and hold a and s (scroll).

26.NoteAt any point in the programming of your basal rate, you have the following optionsto exit.Press f to confirm.Check the new daily BASAL RATE TOTAL.Press f to save and exit.If you want to …save the changesundo the changesThen …jjPress f and check the new daily basal rate total.jjPress f again. Your pump returns to the RUN screen.jj Wait for your Accu-Chek Spirit Combo insulin pump toreturn to the RUN screen, orjjPress d and a simultaneously (exit feature) to exitthe Function screen.39

Selecting a basal rate profileWhen you have programmed more thanone basal rate profile (ADVANCED orCUSTOM MENU), you can select therequired profile.1. 2.Press d to move to the BASAL RATESELECTION screen.Press f to select.The SELECT PROFILE for the currentbasal rate profile is displayed.3.Press a or s to select a basal rateprofile.The SELECT PROFILE screen and its dailybasal rate total appear accordingly.4.Press f to select the displayed profile.The new basal rate profile is activeimmediately.w WarningMake sure that you select an appropriatelyprogrammed basal rate profile.Otherwise there could be inappropriateinsulin delivery.40

2NoteWhen you change your user menu for example fromADVANCED to STANDARD, your current basal rate profilemay not appear.If the basal rate profile number(s) you want does not appear:jj Select the ADVANCED user menu, orjj Assign the basal rate profile to an available basal rateprofile numberA running Temporary Basal Rate increase or decreasestays active, even if you change the basal rate profile onyour pump.Basal rate and bolusDuring normal use, your pump is in RUN mode and insulin iscontinuously delivered to your body, according to the basal rateprofile you have programmed.A bolus can be programmed as required. A bolus is the amountof insulin delivered (in addition to the basal rate) to cover theintake of food and to correct high blood glucose levels. The bolusamount is determined by your doctor or healthcare team’sguidelines and depends on your blood glucose level, your foodintake, and your activity level, as well as stress and illness. Seesection 4.1 Understanding boluses.41

2.6 Connecting the cartridge, adapterand infusion setBefore you change the cartridge, adapter or infusion set,check that your pump is in good working order.See section 7.1.1 Checklist.Insulin can flow uncontrolled from the cartridge or infusion set ifthe cartridge plunger and the piston rod are not properlyconnected and the pump is positioned at a higher level than theinfusion site. Prevent leakage of insulin by correctly inserting thecartridge: move the piston rod to the correct position and twistthe adapter until the cartridge plunger is aligned with the endplate of the piston rod. (See section 3.5 Changing the cartridgeand infusion set)Have the following materials ready:jj A filled Accu-Chek Spirit 3.15 ml Cartridge System with aluer-lock connection (for filling instructions see the instructionsfor use provided with this product)jj An Accu-Chek Spirit Combo insulin pump adapterjj A new Accu-Chek infusion setw WarningEnsure that the cartridge is at room temperature before useto prevent from air bubbles.42

Procedure to connect the cartridge, adapter and infusion set21. 2.3.Remove the protective cap from thecartridge. (Do not touch the cartridge tip.)Push the adapter all the way onto thecartridge tip, to the stop.Carefully prepare a new Accu-Chekinfusion set, following the instructionssupplied for use.4.Hold the adapter and twist the infusionset luer-lock connection by hand,clockwise into the adapter. Do notover-tighten.w WarningTo avoid leakage, tightly attach the infusion set to theadapter. Turn the infusion set luer-lock connector until itstops. Do not over-tighten or use any auxiliary tools, as thismay crack the infusion set luer-lock connector and resultin leakage of insulin.43

2.7 Inserting the cartridgeHave the following materials ready:jj A filled Accu-Chek Spirit 3.15 ml Cartridge System with aconnected Accu-Chek Spirit Combo insulin pump adapterjj A new Accu-Chek infusion setw WarningDo not use your pump for the delivery of medication other thanU100 short-acting regular human insulin or rapid-acting insulinanalogue.Procedure for inserting the cartridge1. 2.3.Press d to move to the STOP YOURPUMP screen.Press f to select.The pump displays the STOP screen, andinsulin delivery stops.Disconnect the infusion set.44

24.5.6.Remove the cartridge, if necessary.Unscrew carefully. Do not pull thecartridge out until it is completelyunscrewed.Press d to move to the CARTRIDGECHANGE screen.Press f to select.Make sure your infusion set is disconnectedand the cartridge has beenremoved.Press and hold f for 3 seconds, untilyou hear a melody.7.The piston rod begins to return. Do nottouch or otherwise disturb the piston rodwhile it is rewinding, as this could resultin damage to your pump.8.When the piston rod has returnedcompletely, the CARTRIDGE VOLUMEscreen displays the maximum volume,315 U.c CautionDo not change the cartridge if thecartridge compartment is not completelydry. When the piston rod is rewinding,insulin solution could enter your pumpand lead to malfunction. If necessary,use a soft cloth to dry the compartment.45

9.see step 10Hold your pump upright. Hold the newfilled cartridge so that the connectedadapter and infusion set points upwards,parallel, and close to the cartridgecompartment.10.see step 11Make sure that the top edge of thethreaded part of the adapter is level withthe top of the cartridge compartment.11.Press a or s to move the piston rodforward until the end plate of the pistonrod is level with the bottom of thecartridge plunger.12.The CARTRIDGE VOLUME decreasesaccordingly on the display.Tip: To prevent air bubbles move thepiston rod to at least 310 Units.46

213. 14.Position your insulin pump upright (withthe adapter pointing upwards). Insert thecartridge into the cartridge compartment.Twist (do not push) the adapter clockwiseuntil it is correctly seated against thecartridge compartment.It is not necessary to apply pressure.Do not over-tighten the adapter, otherwiseit will be difficult to remove thecartridge, adapter and cartridge plunger,and could cause damage to your pump.15. 16. 17.The cartridge is correctly inserted whenthe end plate of the piston rod is correctlyseated against the cartridge plunger.If the end plate of the piston rod is notcorrectly aligned with the cartridgeplunger, remove the cartridge from thecartridge compartment and repeat steps9 to 14.Check that the infusion set luer-lockconnector is still correctly connected tothe adapter. Tighten the infusion setclockwise by hand until it sits tightly inthe adapter.47

18.Press f after correctly inserting thecartridge.Your pump performs a self-test. Seesection 2.3 Start-up process.19.When the self-test process is finished,the Infusion set PRIMING screen isdisplayed.See section 2.8 Priming the infusion set.Start from step 4 in the Pocedure forpriming the infusion set.48

22.8 Priming the infusion setw WarningNever prime an infusion set that is connected to your body asyou risk uncontrolled insulin delivery into your body. Alwaysfollow the instructions for the infusion set you are using.The Accu-Chek Spirit Combo insulin pump stops priming at25 units of insulin. If no insulin emerges from the needle or thereare air bubbles in the tubing after priming, repeat the primingfunction until the infusion set is bubble-free and completely filledwith insulin. When insulin appears at the tip of the needle, pressf to stop priming. The amount of insulin used for priming isnot added to the pump’s history of daily insulin totals.Your pump should be upright during priming, with the adapterpointing upwards to help let air bubbles out of the cartridge andinfusion set.w WarningAir bubbles in the cartridge and infusion set may result in theinfusion of air instead of insulin. If this happens, your bodywill not receive the required amount of insulin. Removebubbles while filling the cartridge and priming the infusionset, and without having the infusion set connected to yourbody.49

Procedure for priming the infusion set1. 2. 3.Press d to move to the STOP YOURPUMP screen.Press f to select.The pump displays the STOP screen, andinsulin delivery stops.Prepare the tubing or cannula for primingaccording to the infusion set’s instructionsfor use.4.5.6.50Press d to move to the Infusion setPRIMING screen.Press f to select. The priming amountof 25 units of insulin is shown on thedisplay.Make sure your infusion set is disconnected.Press and hold f for 3 seconds, untilyou hear a melody. The priming processbegins.To ensure that any air bubbles areremoved always hold your pump uprightand, gently tap it with the bottom in thepalm of your hand.

27.A count-up is shown on the display. Yourpump stops priming after 25 units.The infusion set is properly primed when there are no air bubblesvisible in the tubing and a drop of insulin has come out of theneedle. When the priming process is complete, your pumpreturns to STOP.You can stop the priming process at anytime by pressing f.51

2.9 Positioning the infusion setAlways follow the instructions given to you by your doctor orhealthcare team and the instructions for the infusion set youare using.Change your infusion set as frequently as recommended by themanufacturer.Have the following materials ready:jj Your Accu-Chek Spirit Combo insulin pumpjj A disinfectant for your skinjj A new Accu-Chek infusion set2.9.1 Preparing the infusion siteInfusion site selectionYour doctor or healthcare team will help you choose your infusionsite areas according to a planned rotation pattern. Avoid yourwaistline, bones, scar tissue, recent infusion sites, bruises andsores. Choose an infusion site at least one inch (2.5 cm) awayfrom the navel and previous infusion sites.Infusion site preparationIt is important to prepare the infusion site properly to reduce therisks of infection. Your doctor or healthcare team will provide youwith infusion site preparation guidelines.52

2.9.2 Inserting the cannula1.Make sure that your pump is properlyconnected (including cartridge, adapterand infusion set) and correctly programmedwith your personal settings.2.Make sure your pump is in STOP mode.23.4.5.Wash your hands thoroughly.Disinfect the infusion site and let it drycompletely.Insert the cannula of your Accu-Chekinfusion set according to the instructions.53

NoteIf you use a soft-cannula type infusion set, you mustproceed with a bolus to fill the air space in the cannulaand headset, according to the instructions for the infusionset you are using. Failure to do so could resultin missed insulin dosing. See section 4.2 Programminga Standard Bolus for.If you have read and followed all instructions, cautions, Warningsand notes found in this chapter, you should now be ready todeliver insulin to your body using your Accu-Chek Spirit Comboinsulin pump.w WarningInspect your infusion site at least twice a day for irritation orinfection. Signs of infection may include, but are not limitedto: pain, lumps, redness, heat, or discharge.If you see redness or swelling, change your infusion set andinfusion site immediately and contact your doctor orhealthcare team.Change your infusion headset according to the instructions forthe infusion set you are using and your doctor or healthcareteam’s recommendations.54

22.10 Starting insulin deliveryProcedure for starting insulin delivery1. 2. 3.When your pump is in STOP mode.Press d to move to the START YOURPUMP screen.Press f to select. Your pump shows theRUN screen.Insulin delivery begins within 3 minutes.55

2.11 Stopping insulin deliveryFor your safety, you should only perform certain functions andactions when the pump is in STOP mode. These functions andactions include:jj changing the cartridgejj connecting and disconnecting the adapter and / or infusion setjjpriming the infusion setjj data transferc CautionWhen your Accu-Chek Spirit Combo insulin pump is in STOPmode, no insulin is delivered to your body. You must put yourpump into RUN mode to continue insulin delivery.Procedure to stop insulin delivery1. 2.Press d to move to the STOP YOURPUMP screen.Press f to select. Your pump returns tothe STOP screen.Your pump is now in STOP mode.No insulin is being delivered.56

2STOP-WarningThe STOP-Warning is triggered when your pump switches fromRUN mode to STOP mode, or when a battery is inserted. Thepump emits 2 short beeps and vibrates once every minute. Thiswarns you that insulin delivery has been interrupted.To turn off the STOP-Warning, press either a or s for 3seconds. You then hear a melody and / or feel a vibration,confirming that the STOP-Warning has been turned off.If you press the key too briefly, the STOP-Warning will not beturned off.NoteFor your safety, the volume of the STOP-Warning cannotbe changed. It is independent of the programmed beepvolume.2.12 General safety informationw WarningThe cartridge and infusion set are sterile products intendedfor single use only. Sterility is guaranteed for unopenedpackaging up to the indicated expiry date. Do not use sterileproducts if the packaging is damaged.Do not re-use single-use materials because this might lead toa malfunction of your Accu-Chek Spirit Combo insulin pump,incorrect insulin delivery and / or infection. Always handlethese items with clean hands. Avoid any contact of theinfusion set and the connecting parts of your insulin pumpwith antiseptics, antibiotic creams, soaps, perfumes,deodorants, body lotions, or any other cosmetics. They maycontaminate these parts.57

w WarningAlways check your personal settings before using your newpump, in order to avoid incorrect insulin delivery. Record yourpersonal settings from your current insulin pump, and ensurethat they are correctly programmed into your new Accu-ChekSpirit Combo insulin pump. Incorrect programming of yourpump may cause incorrect insulin delivery.Do not use the pump without knowing your personal settings.If you are not sure about your settings or you are inexperienced,get your doctor or healthcare team to set or checkthem. Only change your settings after consulting your doctoror healthcare team.w WarningThe support of a doctor or healthcare team is vital whentraining on and using your Accu-Chek Spirit Combo insulinpump. Regular visits to your doctor or healthcare team are alsoessential during insulin pump therapy. Always carefully followinstructions from the medical professionals responsible for yourcare.NoteWhen an Extended Bolus, a Multiwave Bolus and / or aTemporary Basal Rate (TBR) is / are active and you putyour pump into STOP mode, a Warning W6: TBR CAN-CELLED and / or a Warning W8: BOLUS CANCELLEDoccur(s). Press f twice for each Warning to confirm andturn them off. See section 8.2 List of Warnings.58

2NoteNoteNoteYour pump cannot detect infusion set leakage. If youdetect any loss of insulin and all parts are correctlytightened, immediately replace the leaking component.Because insulin delivery has been interrupted, check yourblood glucose level and take appropriate action accordingto your doctor’s or healthcare team’s instructions.If the battery is too low, the start-up process may not beable to complete. In this case, the pump beeps five tonesand keeps restarting the process until you remove thebattery or until it is empty.Check the amount of insulin remaining in the cartridge atleast once a day. If you press f from the RUN or STOPscreen, your pump displays the remaining cartridgecontent in units.Before going to sleep, make sure that:jj the cartridge contains enough insulin to last throughthe nightjj the time and date are set correctly59

33 Using your pump in daily lifeThis chapter provides important guidelines on how to use yourpump safely from day to day.3.1 Wearing your pumpAttach your pump safely to your body or clothes to preventdamage. You can use one of our special carrying systems thatenable you to carry your pump on or under your clothes.Remember to wear your pump under your clothes or directly onyour body in cold or wet weather.c CautionWhen wearing your pump, prevent any contact with objects thatcould damage it or accidentally press its keys (e.g. key chains,keys, pocket knives or coins).3.1.1 When not to wear your pumpElectromagnetic fields and hazardous areasw WarningDo not use your pump near electromagnetic fields such asradar or antenna installations, high-voltage sources, X-Raysources, computer tomography, MRI, CAT scan, and all othersources of electrical current, as they may cause your pump tofail. Insulin delivery may stop and an Error E7: ELECTRONICERROR may occur.Always stop your pump, remove and leave it outside theseareas. See Appendix A: Technical Data for more informationabout electromagnetic fields.61

Your pump has been tested against, and complies with, theregulations on electromagnetic interference. Security systems inairports and anti-theft monitoring devices, such as those indepartment stores, should not normally affect the functioning ofyour pump.Because there are so many devices, such as cellular phones,that emit electromagnetic radiation, the effect of such devices onyour pump cannot be ruled out. It is therefore recommended tokeep your pump at least 4 inches (10 cm) away from thesedevices while they are active.Do not use your pump in hyperbaric chambers or in hazardousareas, such as areas where flammable gases or vapours couldbe present. This could cause an explosion.3.1.2 Sport and exerciseExercise is an important part of diabetes management. YourAccu-Chek Spirit Combo insulin pump is designed to enable youto safely perform a range of sporting activities while wearingyour pump. It is important that you protect your pump before youbegin exercise or sporting activities. Do not wear your pumpfor sports that involve body contact such as boxing, football orhockey, since rough contact could damage your pump.Consult our sterile product brochures and accessories cataloguefor more information about carrying systems or contact yourlocal pump support (see the inside back cover) for moreinformation.Always stop and remove your pump before you enter theseareas. If you have questions, contact your local pump support(see inside back cover).Your pump is designed to work in normal barometric conditions(from 500 to 1060 mbar).62

3NoteRapid and extreme changes in air pressure, for examplein an air plane that is taking off or when practising sportslike hang-gliding, can influence insulin delivery, especiallyif there are air bubbles in the cartridge or tubing. This alsoapplies to rapid and extreme changes in temperature; forexample, when leaving a heated room and going outsidein cold weather.We therefore recommend that you wear your pump closeto your body, remove any air bubbles from the cartridgeand tubing and also measure your blood sugar morefrequently in such situations.3.1.3 Travelling with your pumpAsk your doctor or healthcare team about any special steps youneed to take before you travel. Take extra blood glucose testingand pump supplies with you, and find out where to obtainsupplies while you are travelling.When you travel across time zones, make sure that the time anddate on your pump are set correctly to the local time.If you have questions, contact your local pump support(see the inside back cover).w WarningYou must ensure that the Bluetooth ® function is switched offbefore boarding an aircraft, as emissions from your pump orthe Meter could interfere with the electronics systems of theaircraft. See section 6.2 Switching Bluetooth ® ON and OFF63

3.2 Interruption of insulin pumptherapyConsult with your doctor or healthcare team about when and forhow long your insulin pump therapy can be interrupted.Measure your blood glucose level regularly during any insulininterruption. Use a syringe or insulin pen to inject insulinaccording to the instructions of your doctor or healthcare team.w WarningBecause only fast- or rapid-acting insulin is used for insulinpump therapy, only a small amount of insulin is stored in thebody. If insulin delivery is interrupted for any reason – such as:jj If you stop the pumpjj There is a technical problem with the pumpjj The cartridge is leaking and /or the infusion set is leakingjj There is an occlusion in the infusion set or in the headsetjj The cannula has slipped out of the infusion site –you must replace the missing insulin immediately.64

33.2.1 Short interruptions1. 2.3.Press d to move to the STOP YOURPUMP screen.Press f to put your pump in STOPmode.Remove the infusion set or, when using adisconnectable infusion set, disconnectthe transfer set from the headset and usethe protective covers that came with it.Resuming insulin delivery1. Where appropriate, attach a newAccu-Chek infusion set. (See section3.4 Changing the infusion set)Reconnect your infusion set or insert anew one and put your pump into RUNmode.Measure your blood glucose level within2 hours of restarting pump therapy tocheck the function of the system and toensure insulin delivery.65

3.2.2 Long interruptionsWhen you need to interrupt your pumptherapy for more than one day, use thefollowing procedure.1.Put your pump into STOP mode.2.Remove the cartridge, adapter, andinfusion set.3.4.Reinsert the adapter.Remove the battery and reinsert thebattery cover.66Store your pump properly.See section 7.6 Storing your pump.

33.3 Your insulin pump and waterc CautionBefore any contact with water, disconnect and take off yourAccu-Chek Spirit Combo insulin pump. Check your pump dailyto ensure that it is not chipped, cracked or damaged in anyway, and that the battery cover and the adapter are correctlyclosed. Otherwise water, dust, insulin, or other substancesmay enter your pump and lead to malfunction.Disconnect and remove your pump before taking a bath, or goinginto a whirlpool, shower or swimming pool. Avoid exposing yourpump to high humidity, such as in a sauna, as this could result indamage. To make it easy to remove your pump, use disconnectableAccu-Chek infusion sets.3.3.1 Accidental contact with waterYour Accu-Chek Spirit Combo insulin pump is protected againstbrief accidental contact with water. Examples of accidental watercontact include:j Rainj Water splashes while you are cycling, jogging or hikingj Accidental immersion in the sink, washbasin or bath67

What to do after any water contactPut your pump into STOP mode, disconnect the pump from yourbody, and inspect it. Use a soft cloth to dry the outside of thepump, and check the battery compartment and the cartridgecompartment for water. If the battery compartment or cartridgecompartment are wet, turn your pump upside down to let thewater run out and leave it to dry. Do not use warm air such asa hair dryer to dry the pump, as this could damage the pump’shousing. Do not reinsert the battery or the cartridge until thecompartments are completely dry. See section 7.5.1 Cleaningyour pump.c CautionAvoid any contact between your Accu-Chek Spirit Comboinsulin pump, the infusion set, and the connecting parts ofyour insulin pump with health and beauty products (for example:antiseptics, antibiotic creams, soaps, perfumes, deodorants,body lotions, or other cosmetics). These substances coulddiscolour your pump or fog the display.Other liquidsYou do not need to worry about contact between your pump andperspiration or saliva. You must however check your pumpimmediately after contact with other liquids or chemicals such as:jj Cleaning solutionsjj Alcoholjj Beveragesjj Oil or fatSee section 7.5.1 Cleaning your pump.68

33.4 Changing the infusion setWhen you change the infusion set, keep the following informationin mind:jjInfusion sets are sterile products intended for single use only.Sterility is guaranteed for unopened packaging up to theindicated expiry date. Do not use sterile products if thepackage is damaged.jj Correctly tighten the infusion set onto the adapter to avoidleakage. Turn the infusion set luer-lock connector until it stops.Do not turn it any further and do not use auxiliary tools, as thismay crack the infusion set luer-lock connector and result inleakage.jjYour pump cannot detect infusion set leakage. You shouldinspect all parts of your infusion set regularly during the dayand before you go to sleep. If there seems to be any loss ofinsulin and all parts are correctly tightened, look for andimmediately replace a leaking component. Check your bloodglucose level immediately, as insulin delivery has beeninterrupted. Take appropriate action according to your doctor’sor healthcare team’s instructions.Always disconnect your infusion set before changing ajjcartridge or priming the infusion set. Otherwise, you riskuncontrolled insulin delivery into your body. Always follow theinstructions for the infusion set and cartridge system you areusing.69

Procedure for changing the infusion setHave the following materials ready:jj Your Accu-Chek Spirit Combo insulinpumpjj A disinfectant for your skinjj A new Accu-Chek infusion set1.Make sure your pump is in STOP mode.2.Wash your hands thoroughly.3.4.5.Disconnect the transfer set from theheadset.Remove the infusion set from the adapterand dispose of it correctly.Tip: The battery key has a notch that fitsall Accu-Chek infusion set luer-lockconnectors. You can use this to loosenthe luer-lock connector from the adapterif it cannot be loosened by hand.70

36. 7.8.Remove the used infusion headset anddispose of it correctly.Carefully prepare a new Accu-Chekinfusion set for use.Screw the Accu-Chek infusion setclockwise into the adapter.Carefully tighten the luer-lock connectorby hand.9. 10. 11.Prime the infusion set following theinstructions found in section 2.8 Primingthe infusion set.Prepare the infusion site and insert a newinfusion set following the instructions insection 2.9 Positioning the infusion set.Put the pump in RUN mode. Seesection 2.10 Starting insulin delivery.71

NoteIf you use a soft cannula-type infusion set, you mustbegin with a bolus to fill the air space in the cannula andheadset, according to the instructions for the infusion setyou are using. Failure to do so could result in inadequateinsulin dosing. See section 4.2 Programming a StandardBolus.w WarningInspect your infusion site at least twice each day for irritationor infection. Signs of infection may include, but are not limitedto: pain, lumps, redness, heat, or discharge. If you seeredness or swelling, change the infusion headset and theinfusion site immediately and contact your doctor orhealthcare team.Change the headset according to the instructions for theinfusion set you are using and your doctor or healthcareteam’s recommendations.72

33.5 Changing the cartridge andinfusion setHave the following materials ready:jj Your Accu-Chek Spirit Combo insulin pumpjj A disinfectant for your skinjj A new Accu-Chek infusion setjj A filled Accu-Chek Spirit 3.15 ml Cartridge Systemjj A new adapter (this must be changed at least every2 months)Procedure for changing the cartridge and infusion set1. 2.3.Make sure your pump is in STOP mode.Wash your hands thoroughly.Remove the transfer set from theheadset.73

4 . 5.Note Pulling the adapter from the pumpcasing without completelyunscrewing it may result in theplunger staying attached to thepiston rod. If this should happen,please call your local pumpsupport (see inside back cover).Hold your Accu-Chek Spirit Combo insulinpump with the adapter pointing downwards.Remove the adapter and cartridge fromyour pump by unscrewing the adapterfrom the pump casing.6.7.Remove the transfer set from the adapterand dispose of it correctly.Tip: The battery key has a notch thatfits all Accu-Chek infusion set luer-lockconnectors. You can use the batterykey to loosen the luer-lock connectorbetween your infusion set and adapter.Remove the cartridge from the adapterand dispose of the cartridge properly.74

38.9.10.Hold the adapter up to the light to checkfor signs of wear or dirt (especially on theseals inside and outside of the adapter).If necessary, clean the adapter usingwater and dry it. If it shows signs of wearor dirt, replace it immediately.Insert a new cartridge and a new infusionset. See section 2.7 Inserting thecartridge.75

3.6 General safety informationw WarningAlways carry spare sterile products and accessories (infusionset, insulin cartridge, batteries), an insulin pen/syringe, andinsulin. Without insulin, diabetic ketoacidosis may developand may require in-patient hospital treatment.c CautionDo not place your insulin pump in direct sunlight. Overheatingof the insulin and the pump must be avoided. Protect yourinsulin pump from direct exposure to cold wind and temperaturesover 104 °F (40 °C) and below 41 °F (5 °C). Theseconditions may damage the insulin and the housing of yourinsulin pump, and could also cause a malfunction of thebattery. See the instructions for the insulin you are using todetermine the acceptable temperature range.NoteCheck the amount of insulin remaining in the cartridge atleast once a day. Press f from the RUN or STOP screento display the remaining cartridge content in units. Beforegoing to sleep, make sure that:jj The cartridge contains enough insulin to last throughthe nightjj The battery level is OKjj The time and date are set correctly76

44 Boluses and Temporary Basal Rates4.1 Understanding bolusesYour pump can deliver 3 types of bolus:A bolus is the amount of insulin delivered (in addition to the basalrate) to cover the intake of food and to correct high blood glucoselevels. The bolus type and amount is determined by your doctoror healthcare team’s guidelines, your blood glucose level, yourfood intake, your health condition, and your activity level.Discuss the timing, the amount and type of bolus you need withyour doctor or healthcare team.Standard BolusExtended BolusMultiwave Bolusfast deliverydelivery over a programmed periodof timecombines fast delivery with deliveryover a programmed period of time77

4.2 Programming a Standard BolusThere are 2 ways to program a Standard Bolus:NoteYou can not program a new Standard Bolus as long asone Standard Bolus, Quick Bolus or the immediate part ofa Multiwave Bolus is running.Quick BolusUsing StandardBolus menuUsing a and s on your insulinpump, with bolus incrementsdetermined by the userUsing d and f to enter the menuand then a and s to program theamountThe bolus amount per delivery is limited to 50 units using U100insulin.After you program a Standard Bolus, there is a delay of 5 secondsbefore bolus delivery starts. This delay allows you to cancel thebolus by pressing the a or s key. The Warning W8: BOLUSCANCELLED is displayed. Press f twice to confirm and turn offthe alert. See chapter 8 Warning W8: BOLUS CANCELLED.78

44.2.1 Programming a Quick BolusThe following process uses only the a and s keys. You canstart with either key. The recommended steps below are thosedescribed with the first key appearing without round brackets,such as a. For the alternative step, press the key in theparenthesis, such as (s).Because your pump beeps and vibrates to guide you through theprogramming steps, you can program the Quick Bolus withoutlooking at the pump screen. After the bolus is programmed, youcan count the beeps and vibrations of your pump to check thecorrect programming. For safety reason, you should also checkthe display as long as you are less experienced with the pump.The factory setting for the increment of the Quick Bolus is0.5 units.Procedure for programming a Quick Bolus1. 2.3.From the RUN screen, press and hold s(a) until you hear a beep sequence andfeel a vibration.This activates the Quick Bolus function.Press a (s) once for each incrementuntil the required bolus amount isreached. You must not use the key youpressed first.With each pressing of the key, your pumpbeeps and vibrates simultaneously; oncefor each programmed bolus increment.79

4.5.6.5 seconds after the last press of a(s), your pump confirms the total bolusamount with one beep and vibration foreach bolus increment programmed.The Standard Bolus symbol blinks for5 seconds (the bolus delivery start delay).After the bolus delivery start delay, thepump beeps 3 times and vibratesand then begins to deliver the total bolusamount programmed. A countdown ofthe remaining bolus amount appears onthe display.w WarningThe bolus increment that can be programmed into yourAccu-Chek Spirit Combo insulin pump determines the QuickBolus amount using the a and s keys of your insulinpump.Incorrect programming of the bolus increment may causeinappropriate insulin delivery.See section 5.10.1 Adjusting the bolus increment.80

44.2.2 Cancelling a Quick BolusDuring programming(the bolus amountblinks):During confirmation(when the beeps andvibrations occur), orDuring start delay(Standard Bolus symbolblinks):Press the s or a key you used to enter the Quick Bolus programmingoption. This will reset the bolus amount to 0.0 units. You hear a melody.If no new bolus is programmed, your pump returns to the RUN screen andbeeps 3 times and vibrates after 5 seconds.Press s or a. You hear a melody. Your pump returns to the RUN screen.A Warning W8: BOLUS CANCELLED occurs.Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:BOLUS CANCELLED.No bolus is delivered.No bolus is delivered.During bolus delivery(countdown of bolusamount):Press and hold s or a for 3 seconds until you hear a melody. A WarningW8: BOLUS CANCELLED is displayed.Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:BOLUS CANCELLED.You can view the actual bolus amount delivered prior to the cancellation bylooking at the bolus history. See section 5.4.1 Viewing your bolus history.Bolus delivery isinterrupted.NoteMake sure that the cancellation was deliberate, and then program a new bolus, if required.81

4.2.3 Programming a Standard Bolus using Standardbolus menuIndependent of the bolus increment setting, the bolus incrementsfor the menu-guided Standard Bolus are fixed at 0.1 unit. Youcan program this bolus in the Standard Bolus screen byholding the a or s key (scrolling) until the bolus amount isdisplayed.1.Press d to move to the StandardBolus screen.2. 3.4.Press f to select. The BOLUS AMOUNTscreen appears.Press or scroll a to increase or s todecrease the bolus amount.Press f to confirm the bolus amount.The Standard Bolus symbol blinks for 5seconds (the bolus delivery start delay).82

4After this bolus delivery start delay, your pump beeps 3 timesand vibrates and begins to deliver the total bolus amountprogrammed. The countdown of the remaining bolus amountappears on the display.4.2.4 Cancelling a Standard BolusDuring programming(the bolus amountblinks):During the start delay(Standard Bolus symbolblinks):During bolus delivery(countdown of bolusamount):You have 3 options for cancelling during programming:j If you do not press any key for 20 seconds after programming the bolusamount, your pump returns to the RUN screen.j Exit to the Standard Bolus menu by pressing d + a simultaneously.j Set the bolus amount to 0.0 units. Press f to exit.Press d + a, s or a. You hear a melody. Your pump returns to the RUNscreen. A Warning W8: BOLUS CANCELLED occurs.Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:BOLUS CANCELLED.Press and hold s or a for 3 seconds until you hear a melody.You can view the actual bolus amount delivered prior to the cancellation bylooking at the bolus history. See section 5.4.1 Viewing your bolus history.No bolus is delivered.No bolus is delivered.Bolus delivery isinterrupted.83

Cancellation during the start delay and during the bolus deliverywill cause a WARNING W8: BOLUS CANCELED. Press f twiceto confirm and snooze the Warning. See chapter 8.NoteMake sure that the cancellation was deliberate andprogram a new bolus, if needed.4.3 Programming an Extended BolusThe Extended Bolus option enables you to program a bolus to bedelivered over a period of time. This function is helpful duringlong meals, dinners, or receptions, or when you have meals thatare digested slowly. The Extended Bolus may also be appropriatefor people who have gastroparesis (delayed digestion).The duration of bolus delivery can be programmed in 15-minuteintervals up to 12 hours and begins immediately after confirmation.Throughout the bolus delivery, the remaining time andamount of the Extended Bolus and the current hourly basal rateare displayed in the RUN screen.84

4Tip: You can add a Standard or Quick Bolus to an ongoingExtended Bolus. If you cancel the Standard Bolus, the ExtendedBolus continues to run.During the delivery of an Extended Bolus, the programming ofanother Extended Bolus or a Multiwave Bolus is blocked. If youtry to do this, you will receive the Error message: “Boluscurrently running”.If you want to program a different Extended Bolus, put the pumpin STOP mode to cancel the current bolus and to program a newone.Procedure for programming an Extended Bolus1. 2. 3.Press d to move to the ExtendedBolus screen.Press f to select. The BOLUS AMOUNTscreen appears.Press a to increase or s to decreasethe bolus amount.The duration of the last Extended Bolusdelivered appears.85

4. 5.Tip: Press d to switch betweenprogramming the bolus amount and bolusduration.Press d to move to the BOLUSDURATION screen.Press a to increase or s to decreasethe bolus duration.Press f to confirm the bolus amountand duration. The pump returns to theRUN screen. The bolus delivery beginswithin the next 3 minutes.NoteIf a Temporary Basal Rate is active at the same time asthe Extended Bolus, the remaining time and amount ofthe bolus and the amount of the increased or decreasedhourly basal rate are displayed in the RUN screen.86

44.3.1 Cancelling an Extended BolusDuring programming(the bolus amount orbolus duration blinks):During bolus deliveryYou can either:j wait for your pump to return to the RUN screen.j press d and a simultaneously to exit the Function screen.j set the bolus amount to 0.0 units and press f.j If the Extended Bolus delivery has begun, it can be cancelled by putting yourpump into STOP mode. This cancels the bolus delivery and a Warning W8:BOLUS CANCELLED is displayed. Press f twice to confirm and turn off thealert. See chapter 8 Warning W8: BOLUS CANCELLED.The bolus amount delivered up to the cancellation can be reviewed in theBOLUS HISTORY screen. See section 5.4.1 Viewing your bolus history.No bolus is delivered.Bolus delivery isinterrupted.87

NoteIf a Temporary Basal Rate is active at the same time,it is also cancelled when your pump is put intoSTOP mode. A Warning W8: BOLUS CANCELLED anda Warning W6: TBR CANCELLED are displayed.Press f twice to confirm and turn off the first Warning.The second alert appears on the display. Press f twiceto confirm and turn off the second Warning. Both alertsare recorded in the Warnings history.See chapter 8 Warning W6: TBR CANCELLED andWarning W8: BOLUS CANCELLED. Make sure that thecancellation was deliberate and then program a newExtended Bolus (and /or Temporary Basal Rate) if needed.88

44.4 Programming a Multiwave BolusThe Multiwave Bolus option is available in the ADVANCED usermenu. It is designed to better simulate the body’s insulindelivery, and combines an immediate bolus delivery followed byan Extended Bolus delivery. This option can be helpful when youhave meals that include both rapidly and slowly absorbedcarbohydrates.The duration of bolus delivery can be programmed in 15-minuteintervals for up to 12 hours.When programming a Multiwave Bolus, make sure that you areusing the ADVANCED user menu and your pump is in RUN mode.Notej The Multiwave Bolus is available only in the ADVANCEDuser menu.jjYou can add a Standard Bolus to an ongoing MultiwaveBolus. If you cancel the Standard Bolus, the MultiwaveBolus remains running.jjDuring the delivery of a Multiwave Bolus, the programmingof a second Multiwave Bolus or an ExtendedBolus is blocked. If you need a different MultiwaveBolus, put your pump in STOP mode to cancel thecurrent bolus and program a new one.89

Procedure for programming a Multiwave Bolus1. 2. 3.Press d to move to the Multiwave Bolusscreen.Press f to select. The BOLUS AMOUNTscreen appears.Press a or s to increase or decreasethe total bolus amount.Note The first time you press a,the bolus duration of the lastMultiwave Bolus and a defaultimmediate bolus amount appear.The latter increases or decreasesproportionally as you increase ordecrease the total bolus amount.4.Press d to move to the IMMEDIATEBOLUS screen.5.Press d to move to the BOLUSDURATION screen.90Press a or s to correct and set theimmediate bolus amount.Press a or s to correct and set theExtended Bolus duration in increments of15 minutes for up to 12 hours.

4Tip: Press d to loop between programmingthe total BOLUS AMOUNT, IMMEDI-ATE BOLUS and BOLUS DURATION.6.7.Check the total and immediate bolusamounts and the Extended Bolus durationprogrammed on the screens.Press f to confirm both bolus amountsand the bolus duration. The MultiwaveBolus symbol blinks for 5 seconds (bolusdelivery start delay).8.The pump beeps 3 times and vibrates.The immediate bolus delivery begins. Thecountdown of the remaining boluscontinues to appear on the display.NoteIf a Temporary Basal Rate is activeat the same time, the remainingtime and amount of the bolus andthe amount of the increased ordecreased hourly basal rate aredisplayed on the RUN screen.91

4.4.1 Cancelling a Multiwave BolusDuring programming(the bolus amountblinks):During the start delay(Multiwave symbolblinks):During immediatebolus deliveryDuring extendeddeliveryThere are 3 ways to cancel a Multiwave Bolus during programming:j Do not press any key for 20 seconds. The pump returns to the RUN screen.j Exit to the Multiwave Bolus screen by pressing d + a simultaneously.j Set the total bolus amount to 0.0 units and press f.j Press d + a, s or a. The pump beeps and vibrates. The pumpreturns to the RUN screen.j You can cancel immediate delivery by pressing and holding s or a for3 seconds until you hear a melody. This cancels the whole bolus (immediateand Extended Bolus delivery).j You can cancel the extended delivery by putting the pump in STOP mode.This cancels the Extended Bolus.No bolus is delivered.No bolus is delivered.Bolus delivery isinterrupted.Bolus delivery isinterrupted.Cancellation of the bolus during start delay, immediate bolusdelivery and extended delivery will cause a Warning W8 BOLUSCANCELLED. Press f twice to confirm and turn off the alert.See chapter 8 Warning W8: BOLUS CANCELLED.You can review the actual bolus amount delivered before thecancellation by looking at the bolus history. See section5.4.1 Viewing your bolus history.92

NoteIf a Temporary Basal Rate is active at the same time, it isalso cancelled when your pump is put in STOP mode. TheWarning W8: BOLUS CANCELLED and a Warning W6: TBRCANCELLED is displayed.Press f twice to confirm and turn off the first Warning.The second Warning appears on the display. Press ftwice to confirm and turn off the second Warning. BothWarnings are recorded in the alarm history. See chapter8 Warning W6: TBR CANCELLED and Warning W8: BOLUSCANCELLED. Make sure the cancellation was intendedand then program a new Multiwave Bolus (and / orTemporary Basal Rate), if needed.4.5 Programming a TemporaryBasal Rate (TBR)Your pump allows you to temporarily increase or decrease yourbasal rate. This enables you to match your changing insulinneeds due to increased or decreased activity level, illness, orstress.Typically, a basal rate is set to 100 %, but you can:jj Increase it to 250 % for up to 24 hoursjj Decrease it to 0 % for up to 24 hoursWhen you increase or decrease your basal rate, each hourlybasal rate for the duration you program is increased or decreased.The characteristic shape of your basal rate profileremains and does not become a flat curve, if the change is largerthan 0 %. For 0 % the basal rate profile becomes a flat line andno insulin (except boluses) is delivered during the programmedduration.Discuss programming a Temporary Basal Rate with your doctoror healthcare team.493

NoteA running Temporary Basal Rate increase or decreaseremains active, even if you have changed the basal rateprofile.You can only program a Temporary Basal Rate when your pumpis in RUN mode.Procedure for programming a Temporary Basal Rate1. 2.Press d to move to the TemporaryBasal Rate (TBR) screen.Press f to select. The TBR PERCENTAGEscreen appears.NoteIf no Temporary Basal Rate iscurrently active, the percentage isset to 100 %. If a Temporary BasalRate is active, its duration andpercentage appear on the RUNscreen.94

43.Press a or s to increase or decreasethe basal rate.Tip: When you increase (or decrease) theTemporary Basal Rate, the duration ofyour previous Temporary Basal Rateincrease (or decrease) appears. However,when you use your pump for the firsttime, a default value appears.4.Press d to move to the TBR DURATIONscreen.Press a or s to correct and set theduration.Tip: You can switch between programmingthe basal rate percentage andduration by pressing d.5.Press f to save and exit.The new Temporary Basal Rate isimmediately activated.When a Temporary Basal Rate is active,the pump emits a beep once every hour.95

NoteNoteDuring Temporary Basal Rate delivery, the increase ordecrease in percentage, the increased or decreasedhourly basal rate (hourly basal rate plus TBR percentage),and the remaining time are displayed in the RUN screen.An arrow pointing upwards symbolizes a Temporary BasalRate increase; an arrow pointing downwards symbolizes aTemporary Basal Rate decrease.If an Extended Bolus or a Multiwave Bolus is active at thesame time, the remaining time and amount of the bolusand the amount of the increased or decreased hourlybasal rate are displayed in the RUN screen.Example: Extended Bolus runningTBR OVER AlertAt the end of a Temporary Basal Rate, a Warning W7: TBR OVERis displayed. Press f twice to confirm and turn off theWarning. See chapter 8 Warning W7: TBR OVER.Remaining durationExtended Bolus symbol96

44.5.1 Cancelling a Temporary Basal RateDuring programming:During delivery:There are 3 ways to cancel a Temporary Basal Rate during programming:j Do not press any key for 20 seconds. The pump returns to the RUN screen.j Exit to the Temporary Basal Rate (TBR) screen by pressing d + asimultaneously.j Set the TBR percentage to 100 %. Press f to save and exit.There are 2 ways to cancel a Temporary Basal Rate during delivery:j Set the TBR percentage to 100 %. Press f to save and exit. A Warning W6:TBR CANCELLED is displayed.j Or you can put your pump in STOP mode. The Temporary Basal Rate deliveryis cancelled, as well as any Extended or Multiwave Bolus that is currentlyrunning. A Warning W6: TBR CANCELLED is displayed. Press f twice toconfirm and turn off the alert.Pump continues todeliver normal basalrate.Pump returns tonormal basal rate.97

NoteIf an Extended Bolus or a Multiwave Bolus is active at thesame time, it is also cancelled when your pump is put intoSTOP mode. A Warning W8: BOLUS CANCELLED and aWarning W6: TBR CANCELLED are displayed.Press f twice to confirm and turn off the first alert. Thesecond alert appears on the display. Press f twice toconfirm and turn off the second alert. Both alerts arerecorded in the alarm history. See chapter 8 Warning W6:TBR CANCELLED and Warning W8: BOLUS CANCELLED.Make sure that the cancellation was intended and thenprogram a new Temporary Basal Rate (and /or anExtended or Multiwave Bolus), if needed.4.6 General safety informationw Warningj Incorrect programming of your insulin pump may causeinappropriate insulin delivery.j Your insulin pump must be programmed with your personalsettings before starting insulin pump therapy.j Do not operate your insulin pump without knowing yourpersonal settings.j If you are not sure about your personal settings, or you areless experienced, ask your doctor or healthcare team tocheck your personal settings.j Work with your doctor or healthcare team to determine thetiming, amount, and type of bolus you need to deliver.j Make sure you know your personal carbohydrate-to-insulinratio and your correction factor.w WarningWhen your pump is in STOP mode it does not deliver insulin.Put the pump in RUN mode to continue insulin delivery.98

55 Personalizing your pumpThis chapter explains how to use the available menu options, andto personalize your pump to match your level of experience withinsulin pump therapy.5.1 IntroductionUsing the 4 keys on the pump, and their combinations, you canaccess the menu options and their relevant screens. This enablesyou to, for example:jj Program the pumpjj Perform a functionjj Change a settingjj Store information5.1.1 User menusYour Accu-Chek Spirit Combo insulin pump has been designed toadapt to your level of experience in pump therapy – whether youare a beginner or an experienced pump user. Your Accu-ChekSpirit Combo insulin pump “grows” with you!You can use one of 3 menus – STANDARD, ADVANCED orCUSTOM – to access the functions and settings you will needfrom day to day.NoteYour Accu-Chek Spirit Combo insulin pump has beendesigned for use with the Meter. This intelligent bloodglucose meter enables you to communicate with the pumpusing Bluetooth ® wireless technology.99

StandardADVANCEDCUSTOMThis menu provides all the basic functionsyou need for successful pump therapy. Ifyou are new to pump therapy, we recommendthat you start with this menu. As youbecome more experienced, you may wishto change to the ADVANCED user menu.This menu provides the complete rangeof the Accu-Chek Spirit Combo insulin pumpfunctions. It includes all the functions fromthe STANDARD user menu, plus a widerange of functions for the more experienceduser.Because the Accu-Chek Spirit Combo insulinpump has so many features, you may wantto decide which screens are displayed whenyou scroll through the menu choices. Usingappropriate PC software, this menu enablesyou to hide screens of the ADVANCED usermenu and thereby customize your pump.At the beginning of this User Guide, you will find fold-outdiagrams of the STANDARD, CUSTOM and ADVANCED usermenus.NoteFor your safety and convenience during programming,your Accu-Chek Spirit Combo insulin pump returns to theRUN or STOP screen if no key is pressed within 20 seconds.The changes you made before your pump timed out willnot be saved.100

55.2 Selecting a user menuNoteFor guidance in choosing the most suitable user menu,see section 5.1.1 User menus. If you are still not surewhich menu to choose, discuss this with your doctor orhealthcare provider.Procedure for selecting a user menu1.2. 3.Press d to move to the MENU SETTINGSscreen.Press f to select.The SELECT USER MENU screen isdisplayed.Press a or s to select a user menu.Press f to confirm.The selected basal rate profile and itsdaily insulin total appear, or …101

4.5.… if the previous basal rate profile is notavailable from the selected user menu,dashes appear instead.Press a or s to select a basal rateprofile, if required.Check the (new) basal rate profile and itsdaily insulin total.Press f to save and exit.The new user menu and basal rate profile are active immediately.c CautionA running increased or decreased Temporary Basal Rate willremain active, even if you change the basal rate profile. TheTemporary Basal Rate is based on the new basal rate.102

55.3 Standard user menuThe following is a list of menu options from the STANDARD usermenu. To view the order in which they appear on the display,refer to the menu diagram below:j j Press d to move towardsjjPress d + a simultaneouslyto move backwardsRUNSTOPff103

Some of the functions have already been described elsewhere inthis User Guide, as listed below. The remaining functions aredescribed following the list.TIME AND DATE SETTINGSjjSee section 2.4 Setting the time and date.BASAL RATE PROGRAMMINGjjSee section 2.5.1 Programming your basal rate profile.CARTRIDGE CHANGEjjSee section 2.7 Inserting the cartridge.Infusion set PRIMINGjjSee section 2.8 Priming the infusion set.START YOUR PUMPjjSee section 2.10 Starting insulin delivery.Quick BolusjjSee section 4.2.1 Programming a Quick Bolus.STANDARD BOLUSjjSee section 4.2 Programming a Standard Bolus.EXTENDED BOLUSjjSee section 4.3 Programming an Extended Bolus.TEMPORARY BASAL RATE (TBR)j j See section 4.5 Programming a Temporary Basal Rate (TBR).MENU SETTINGSjjSee section 5.2 Selecting a user menu earlier in this chapter.BLUETOOTH SETTINGSjjSee chapter 6 Using the Accu-Chek Spirit Combo insulin pumpwith the Meter.STOP YOUR PUMPjjSee section 2.11 Stopping insulin delivery.104

55.4 Viewing your pump dataThe memory of your Accu-Chek Spirit Combo insulin pump storesall the events (Warnings and Errors, programming operations andinsulin delivery records) up to 4500 events. This data correspondsto about the last 90 days of use, and can be accessed on apersonal computer using Accu-Chek software products.The following data can be reviewed directly on your Accu-ChekSpirit Combo insulin pump:Bolus historyAlarm historyHistory of dailyinsulin totalsTemporary BasalRate historylast 30 boluseslast 30 Warnings and Errorslast 30 daily totals of insulindeliveredlast 30 increases and decreases inbasal ratePump timerremaining time in days until thepump timer expires105

5.4.1 Viewing your bolus historyThe BOLUS DATA screen allows you to view up to the last30 bolus deliveries, starting with the most recent entry.Each bolus data screen displays:jj Bolus type (Standard, Extended or Multiwave Bolus)jj Bolus duration ( – only displayed for an Extended orMultiwave Bolus)jj Timejj Datejj Entry number (01 is the most recent) of total entries(example 01/30) of a delivered bolusBolus amount / typeBolus timeDateEntry numberTip: You can enter the BOLUS DATA screen also from theQUICK INFO screen. See section 1.2.3 Display screens.Procedure for viewing the bolus history1. 2. 3.Press d to move to the MY DATAscreen.Press f to select.The BOLUS DATA screen appears,showing the most recent bolus information.Press a or s to view the entries.Press f to exit.106

55.4.2 Viewing the Error and Warning historyThe alarm data menu allows you to view up to the last30 Warnings and Errors, starting with the most recent entry.Each alarm data screen displays:jj Number and type of the Warning or Error (for example, W6)jj Warning or Error (for example, TBR CANCELLED)jj Timejj Datejj Entry number (01 is the most recent) of total entries(example 01/30) of a Warning or ErrorProcedure for viewing the alarm history1. 2. 3.Press d to move to the MY DATAscreen.Press f to select.Press d to move to the ERROR DATAscreen.Press a or s to view the entries.Press f to exit.107

5.4.3 Viewing the history of daily insulin totalsThis function allows you to view up to the last 30 daily totals ofinsulin delivered (from midnight to midnight; including basal rateplus boluses), starting with the most recent entry.Each screen displays:jj Daily total of insulin deliveredjj Datejj Entry number (01 is the most recent) of total entries(example 01/04) of a daily insulin totalProcedure for viewing the daily insulin totals1. 2. 3.Press d to move to the MY DATAscreen.Press f to select.Press d to move to the DAILY TOTALSscreen.Press a or s to view the entries.Press f to exit.108

55.4.4 Viewing the Temporary Basal Rate historyThis option allows you to view up to the last 30 Temporary BasalRate (TBR) increases or decreases, starting with the most recententry.Each TBR history screen displays:jj TBR increase or decrease in percentagejj TBR durationjj Timejj Datejj Entry number (01 is the most recent) of total entries (example01/30) of a delivered Temporary Basal RateProcedure for viewing the Temporary Basal Rate history1. 2.3.Press d to move to the MY DATAscreen.Press f to select.Press d to move to the TBR DATAscreen.Press a or s to view the entries.Press f to exit.109

5.4.5 Viewing the time remaining (pump timer)The pump timer function only occurs on a backup or loan pump.Your backup pump has been provided for contingency use only.It has a pre-set operating time of 180 days. When you first startyour backup or loan pump, it will begin to count down theremaining days. Before the operating time expires, you will beprompted with a Warning W5: PUMP TIMER or W9: LOANTIMEWARNING message, and the pump timer symbol will be displayedin the RUN and STOP screen. When the operating time hasexpired, you will be prompted with an Error E5 or E9: END OFOPERATION, and the pump will turn to STOP mode.After an Error E5 or E9, the pump cannot be switched to RUNmode again.See chapter 8: Warning W5, W9: PUMP TIMER and Error E5,E9: END OF OPERATIONProcedure for viewing the time remaining1. 2.NoteThis setting is country-specificand may not be visible on yourpump.Press d to move to the MY DATAscreen.Press f to select.Press d to move to the PUMP TIMERscreen.The number of days remaining until thepump timer expires is shown.110Press f to exit.

55.5 Transferring your data to a computerThe built-in infrared interface on the bottom of your Accu-ChekSpirit Combo insulin pump enables you to transfer data betweenyour pump and a PC.The memory of your Accu-Chek Spirit Combo insulin pumpstores all the events (Warnings and Errors, programming operationsand insulin delivery records) up to a total of 4500 events.This data corresponds to about the last 90 days of use, andcan be accessed on a personal computer using Accu-Chekinformation management products (for details see the userinformation provided with the software).For availability of the appropriate software see Appendix C.Procedure for transferring your data1. 2. 3.Put your pump in STOP mode.Press d to move to the DATA TRANSFERscreen.Press f to select.Press f. A melody signals that yourpump is ready to transfer data.111

4.Set up your pump with a cartridge, adapter, and a new infusionset, and put it in RUN mode if necessary.When the data transfer is complete,press f to return to the STOP screen.NoteYour pump will return to STOP mode 15 minutes after thelast data transfer when the DATA TRANSFER screen isselected.You can press twice d + a to exit while data is beingtransferred. The data transfer is interrupted, and the ErrorE12: DATA INTERRUPTED occurs. See chapter 8.112

55.6 Pump settingsThese settings relate to the practical use of the pump. Forsettings relating to your therapy, see 5.10 Therapy settings laterin this chapter.5.6.1 Turning Keylock on and offThe Keylock function allows you to lock the 4 keys of yourAccu-Chek Spirit Combo insulin pump. This is an importantsafety measure that prevents you from accidentally activatingfunctions, for example while sleeping or during contact sports.If the Keylock is turned on and no key is pressed for 10 secondsafter your pump has returned to the RUN screen or STOP screen,all 4 keys are locked.Procedure for turning the Keylock on or off1. 2.3.Press d to move to the PUMPSETTINGS screen.Press f to select.The current Keylock status (ON or OFF)appears.Press a or s to turn the Keylock ONor OFF.Press f to save and exit.113

Procedure for unlocking the KeylockIf you press any key while the screen is blank, the Keylock symbolindicates that the keys are locked.NoteThe Keylock remains unlocked during fast bolus delivery ofStandard or Multiwave Bolus.1. 2.3 seconds to confirm that the Keylock isunlocked.From the blank screen, press and holdd + s for 3 seconds.You hear 3 beeps in RUN or STOP modewhen you press the keys and again afterIf no key is pressed for 10 seconds afteryour pump has returned to the RUN orSTOP screen, all 4 keys are automaticallylocked.114

55.6.2 Adjusting the sound volumeYour pump emits different acoustic signals in different handlingsituations to facilitate handling e.g. for blind or partially-sightedusers. For details on the meaning of the sound patterns, see theAppendix “Beeps and melodies”. You can adjust the volume ofthe beeps according to your personal preference. There are 5volume levels available: off, low, medium, high and maximum.NoteThe volume of the STOP-Warning is independent of theprogrammed beep volume – it always sounds at themaximum level. If the beeps are turned off, and a Warningor Error occurs, the beeps become active again to ensurethat you are aware of the Warning or Error. If the Warningor Error is not cancelled, the beeps gradually increase involume until the maximum level is reached.Procedure for adjusting the sound volume1. 2.Press d to move to the PUMP SETTINGSscreen.Press f to select.Press d to move to the SOUNDVOLUME screen.Press a or s to adjust the soundvolume.Press f to save and exit.115

5.6.3 Changing signal settingsThe Accu-Chek Spirit Combo insulin pump enables you to choosehow you want your pump to alert you when a Warning or Erroroccurs.You have 3 options:Beep onlyVibrate onlyBeep and vibrateFor your safety, if you do not respond to the vibration, the pumpstarts beeping after one minute.Procedure for changing the signal settings1. 2.Press d to move to the PUMPSETTINGS screen.Press f to select.Press d to move to the SIGNALSETTINGS screen.Press a or s to set the signals.116Press f to save and exit.

55.6.4 Display orientationYour pump allows you to turn the display by 180°, so that youcan view it more easily, depending on how you are wearing thepump.Note If you turn the display orientation of your pump by 180°,the functions of the a and s keys are also reversed.The functions of the d and f keys remains the same,whichever screen orientation you choose.Procedure for setting the display orientation1. 2. 3.Press d to move to the PUMPSETTINGS screen.Press f to select.Press d to move to the ORIENTATIONscreen.Press a or s to select the displayorientation.The current orientation is displayed.Press f to save and exit.117

5.6.5 Setting the display contrastYour pump allows you to adjust the display contrast to suit yourpreferences.Procedure for setting the display contrast1. 2.Press d to move to the PUMPSETTINGS screen.Press f to select.Press d to move to the DISPLAYCONTRAST screen.Press a or s to select the desiredcontrast level.118Press f to save and exit.

55.6.6 Selecting the languageYour pump can display the information in several languages.You can chose the language according to your preferences.Procedure for setting the language1. 2.Press d to move to the PUMPSETTINGS screen.Press f to select.Press d to move to the LANGUAGEscreen.Press a or s to select a language.Press f to save and exit.119

5.7 ADVANCED user menuThe following is a list of additional menu options available in theADVANCED user menu. To view the order in which they appearon the display, refer to the menu diagram below:j j Press d to move towardsjjPress d + a simultaneouslyto move backwardsRUNSTOPBRP = Basal Rate profile 2 – 4ff120BRP 4BRP 3BRP 2BRP 4BRP 3BRP 2

5NoteThe ADVANCED user menu contains all the options fromthe STANDARD user menu.Some of the functions are described elsewhere in thisUser Guide, as listed below. The remaining functions aredescribed in this chapter following the list.Multiwave BolusjjSee section 4.4 Programming a Multiwave Bolus.5.8 Basal rate profilesYour pump has 5 different basal rate profiles to match yourchanging insulin needs (for example, Monday to Friday orExercise Day or Sleeping Late Day).Discuss additional basal rate profiles with your doctor orhealthcare team. Also, consult with your doctor or healthcareteam before changing basal rate profiles, as this may affect howyou use your pump.5.8.1 Programming additional basal rate profilesw WARNINGYour Accu-Chek Spirit Combo insulin pump must be programmedwith your personal settings prior to starting insulinpump therapy. Do not operate your pump without knowingyour personal settings. If you are not sure about your personalsettings or you are inexperienced, ask your healthcareprovider to check your personal settings.121

Procedure for Programming additional basal rate profiles1. 2.See section 2.5.1 Programming yourbasal rate profile.Press d to move to the BASAL RATEPROGRAMMING (2, 3, 4, 5) screen youwish to program.The hourly basal rates for each additionalbasal rate profile are set in the same wayas for basal rate profile 1.Press f to select.NoteOnly basal rate profiles that are accessible in your currentuser menu are available. If the basal rate profilenumber(s) do(es) not appear, select the ADVANCED usermenu, or program the basal rate profile to an availablebasal rate profile number.122

55.8.2 Selecting a basal rate profileProcedure for selecting a basalrate profile1. 2.Press d to move to the BASAL RATESELECTION screen.Press f to enter.Press a or s to select a basal rateprofile. The selected basal rate profileand its daily insulin total appear.Press f to select.The new basal rate profile is active immediately.NoteOnly basal rate profiles that are accessible in your currentuser menu are available.A running Temporary Basal Rate increase or decreasestays active, even if you change the basal rate profile onyour pump.123

5.9 Setting a ReminderYou can set both single and multiple Reminders on your pump.Multiple Reminders are repeated at a set time every day. You canuse this feature to remind you, for example, when you need totest your blood glucose.Procedure for setting single or multiple Reminders1. 2. 3.Press d to move to the ReminderSETTINGS screen.Press f to select. The current Reminderstatus and alarm time appear.Press a or s to change the Remindersetting to OFF, ONCE or EVERY DAY.124

54.5.Press d to move to the HOUR screen.Press a or s to set the hour.Press d to move to the MINUTE screen.Press a or s to set the minute.Press f to save and exit.Turning off the ReminderWhen the Reminder sounds, the Reminder screen is diplayed.Press f twice to snooze and confirm and return to RUN orSTOP mode (See also chapter 8.4 R1).125

5.10 Therapy settingsThese settings relate to the therapeutic use of the pump. Forsettings relating to the practical use of the pump, see Pumpsettings earlier in this chapter.your Accu-Chek Spirit Combo insulin pump is adjustable. It isinitially set to 0.5 units per key-press, but it can be changedto 0.1, 0.2, 0.5, 1.0 or 2.0 units.5.10.1 Adjusting the bolus incrementDesigned for those patients who may need large or smallamounts of insulin, the bolus increment for the Quick Bolus ofw WarningThe bolus increment determines the Quick Bolus amount perkey press using the a and s keys. Incorrect programmingof the bolus increment may cause inappropriate insulindelivery.Procedure for adjusting the bolus increment1. 2.Press d to move to the THERAPYSETTINGS screen.Press f to select.Press d to move to the BOLUSINCREMENT screen.Press a or s to select a bolusincrement.126Press f to save and exit.

55.10.2 Adjusting the prime amountThe prime amount needed to fill an infusion set depends on thelength of the infusion set tubing. The shorter your infusion settubing, the less insulin will be required to prime the infusion set.The default setting for the prime amount is 25 units of U100insulin.NoteThe amount of insulin used for the priming is not added tothe history of daily insulin totals.Procedure for adjusting the prime amount1. 2.Press d to move to the THERAPYSETTINGS screen.Press f to select.Press d to move to the PRIME AMOUNTscreen.Press a or s to select a primequantity between 0.0 and 50.0 units.Press f to save and exit.127

5.10.3 Locking basal rate profilesYour Accu-Chek Spirit Combo insulin pump allows you to adaptyour hourly basal rate profile as needed. You can then lockyour basal rate profiles to provide additional protection againstaccidentally changing a basal rate during normal operation. Ifthe basal rate lock is set to ON, programming of the basal rateprofiles 1, 2, 3, 4 and 5 is blocked.If you try to program a basal rate while the BASAL RATE LOCK isturned ON, the key symbol in the BASAL RATE TOTAL screenindicates that basal rate programming is locked.The a and s functions are blocked.However, you can still change between the different basal rateprofiles 1 to 5.Procedure for locking the basal rate profiles1. 2.Press d to move to the THERAPYSETTINGS screen.Press f to select.Press d to move to the BASAL RATELOCK screen.Press a or s to turn the basal ratelock ON or OFF.128Press f to save and exit.

55.10.4 Automatic OffAutomatic Off is a safety feature that stops insulin delivery andtriggers Error E3: AUTOMATIC OFF if no keys are pressed withina programmed time period in RUN mode. This feature can eitherbe set to OFF or programmed up to 24 hours in 1-hour intervals.The factory setting is OFF.Discuss using the Automatic off function with your doctor orhealthcare team.Procedure for using Automatic Off1. 2. 3.Press d to move to the THERAPYSETTINGS screen.Press f to select.Press d to move to the AUTOMATICOFF screen.Press or scroll a to increase or s todecrease the duration for the Automaticoff in 1-hour intervals.If you would like to set the Automatic Offfunction to off, press s until “0 hours”and OFF appear on the display.Press f to save and exit.129

5.11 CUSTOM user menuThe CUSTOM user menu is designed to adapt your pump to yourspecial requirements and preferences. It allows you or yourhealthcare provider to display or hide screens and therebycustomize the individual user menus.j j Press d to move towardsjjPress d + a simultaneouslyto move backwardsRUNffSTOP130

5NoteBy default, the CUSTOM user menu contains all of thefunctions available except the following:jj Multiwave BolusjjBasal rate profiles 3, 4 and 5To change the CUSTOM user menu, you, your doctor, or yourhealthcare provider must use the Accu-Chek PC configurationsoftware.131

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66 Using the Accu-Chek Spirit Combo insulin pump with the MeterThis chapter describes how the Accu-Chek Spirit Combo insulinpump works with the Meter, and explains how to pair the 2devices using Bluetooth ® wireless technology.NoteIn this User Guide the term “Meter” always refers to theAccu-Chek Aviva Combo Blood Glucose Meter orAccu-Chek Performa Combo Blood Glucose Meter.6.1 MeterThe Meter – available separately – is both a blood glucose meterand a remote-control device for your Accu-Chek Spirit Comboinsulin pump. Using the Meter, you can program your pumpwithout handling it, and also receive bolus advice and reviewhistory information.“Pairing” means to set up a connection between the 2 devicesusing Bluetooth ® wireless technology. This is a secure connection,and there is no risk of your pump receiving signals from anyother device.NoteDo not leave your Meter unattended as long as it isconnected to your pump. Otherwise your pump could bemanipulated remotely without your control (for example:children playing with the Meter).NoteThe pump cannot communicate with the Meter usingBluetooth ® wireless technology when the devices aremore than 2 meters apart.133

6.1.1 Tasks that must be performed on the pumpThe following tasks cannot be performed remotely using theMeter:jj Changing the cartridgejjPriming the infusion setjj Data transfer®j j Bluetooth settingsjj Display settingsAll the other functions available on the Accu-Chek Spirit Comboinsulin pump can be performed using the Meter.Before using your pump together with the Meter you must readthe documentation (Owners booklet) provided with this product.134

66.2 Switching Bluetooth ® ON and OFFw WarningYou must ensure that Bluetooth ® is switched off on bothdevices before boarding an aircraft, as emissions from yourpump or the Meter could interfere with the electronicssystems of the aircraft.To prolong the battery life and avoid accidental changes on yourpump, you should switch off Bluetooth ® wireless technology,if the Meter is lost, stolen or, you plan not to carry it with you fora longer period of time.Procedure for switching Bluetooth ® ON and OFF1. 2.Press d to move to the BLUETOOTHSETTINGS screen.Press f to select to the ON / OFF screen.Press a or s to switch on theBluetooth ® function.Press f to save and exit.135

6.3 Pairing your pump with the MeterIf you have already acquired the Meter together with theAccu-Chek Spirit Combo insulin pump, the 2 devices will alreadyhave been paired.When pairing your Accu-Chek Spirit Combo insulin pump withthe Meter, place both devices on a table or desk, so that you cansee the displays of both devices clearly.You should not perform the pairing process in crowded areas,since the emissions of other electronic devices could interfere withthe connection.Procedure for Pairing1. 2. 3.Press d to move to the BLUETOOTHSETTINGS screen.Press f to select to the ON / OFF screen.Press a or s to switch on theBluetooth ® function.Press d to display the PAIRED DEVICEscreen.136

6NoteWhen Bluetooth ® is turned off,you cannot access the PairedDevice menu.4.Pump screenIf the pump screen indicates that nopaired device is available, turn on theMeter in pairing mode by holding down* and simultaneously pressing +.Meter screen5.6.The pump begins searching and detectsthe Meter, displaying its serial number(This process may take several minutes).Press the d key on the pump to see theADD DEVICE screen, and press f toinitiate pairing.Pump screenPair with PumpEnsure Pump is in pairingmode through Bluetoothmenu on PumpWaiting . . .METER574328192Press a or s to select the number,which is also shown on your Meterscreen.Press f on the pump to confirm thatyou want to pair the Meter.Meter screen137

7.Pump screenThe pump begins the pairing process andshows a 10-digit code. Enter the code onthe Meter display, using =, x and zand then = to move to the next digit.Confirm the complete code with ..8.Meter screenAfter the pairing is completed press + toturn off the Meter.Meter screen9.10.If the pairing is not successful in a firstattempt, wait a few minutes before yourepeat the procedure in a safe or lesscrowded environment.The pump now shows the DEVICE PAIREDscreen. Press f to confirm the pairing.The pump displays the PAIRED DEVICEscreen. You can return to the RUN screenby pressing f.138

66.4 Troubleshooting the Bluetooth ®connectionIn this case of problems with the Bluetooth ® connection or afterthe appearance of the W10: BLUETOOTH FAULT, you haveto repeat the pairing procedure described in section 6.3 Pairingyour pump with the Meter.Since only one Meter at a time can be paired with your pump,you must delete the pairing before you can pair your pump with anew Meter.1. 2. 3.Press d to move to the BLUETOOTHSETTINGS screen.Press f to enter the BLUETOOTHON / OFF screen.Press d to move to the PAIRED DEVICEscreen.139

4.Press d to move to the DELETE DEVICEscreen.Press f once to delete the pairing anda second time to confirm.6.4.1 Handling Warnings and ErrorsThe Accu-Chek Spirit Combo insulin pump and Meter behave inthe following ways when Warnings and Errors occur.jj If both devices are switched on and paired you can enter theMeter’s Pump menu and snooze and confirm the Warning orError through the Meter.jj If the Meter is switched off, and you switch it on in response toa Warning, Error or Reminder on the pump, the Meter switchesimmediately to the Pump menu. All the functions available onthe pump are performed from the Pump menu of the Meter.NoteThe above points do not apply in the case ofE7: ELECTRONIC ERROR.Then repeat the pairing procedure described in section 6.3 Pairingyour pump with the Meter.If the pairing is still not successful, contact local pump support(details on inside back cover).140

66.4.2 Use in aircraftw WarningYou must ensure that Bluetooth ® is switched off on bothdevices before boarding an aircraft, as emissions from yourpump or the Meter could interfere with the electronicssystems of the aircraft.141

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77 Care and MaintenanceThis chapter explains how to take care of your pump and keep itproperly maintained.GuaranteeRoche Diagnostics guarantees that your pump functionsaccording to its specifications only where all servicing of yourpump is carried out and / or authorized by Roche Diagnostics.c CautionDo not perform any servicing or repair on your Accu-ChekSpirit Combo insulin pump. For servicing or repair, contactyour local pump support (see inside back cover).7.1 Inspecting your pumpYour pump must be properly maintained to guarantee accurateinsulin delivery.Check the pump display regularly during the day and before yougo to sleep, and especially if for any reason you might not beable to hear the beeps or feel the vibrations.AccessoriesUse only Accu-Chek sterile products and accessories designedto be used with your pump. Replace and discard these itemsaccording to your doctor’s or healthcare team’s recommendationsand the instructions that come with these items.143

7.1.1 ChecklistCheck your pump daily, and make sure that:jj The pump casing, the display, and the cartridge are notchipped or cracked and that the display does not showincomplete or abnormal letters or symbols.jj You carefully inspect the cartridge. Make sure that the actualamount of insulin in the cartridge equals the displayedcartridge amount on the Quick Info screen.jj You inspect all parts of your pump and infusion set regularlyduring the day and before you go to sleep. If you detect anyloss of insulin, immediately replace the leaking component.jj The battery cover is correctly tightened and positioned, in linewith the pump casing.jj The adapter is correctly attached.jj Your infusion set is primed, free of air bubbles, and tightlyconnected to the adapter.jj Your infusion set is inserted according to the instructions forits use.jj Your infusion site is secure, comfortable, and free of irritationor infection.jj The cartridge is free of air bubbles.jj Your pump is in RUN mode.jj The basal rates are set correctly according to your doctor’s orhealthcare team’s recommendations.jj The time and date are set correctly.jj The Temporary Basal Rate changes are set according to yourdoctor’s or healthcare team’s recommendations.jj The beeps and / or vibrations are set.jjYou have your personal emergency kit with you.(See section 1.5 Emergency kit)144

77.2 Damage to your pump7.2.1 What to do if you drop your pumpIf the pump is dropped it could be damaged, as well as the sealthat protects it against water. So be careful not to drop yourpump! Use the specially designed pump carrying system to helpavoid dropping your pump. See Roche Diagnostics sterileproducts and accessories catalogues and brochures for moreinformation, or contact your local pump support (details on insideback cover).If you drop your pump:jj Check that all the connections in your infusion set are stilltight, and if they are not, reconnect or tighten themjjCheck your pump, its sterile products, and accessories forchips and cracksjj Change the cartridge if it is damagedPut your pump in STOP mode, and take out and reinsert thebattery, so that the self-test is started.NoteIf a Temporary Basal Rate, an Extended Bolus or aMultiwave Bolus is active at the same time, it is cancelledwhen your pump is put into STOP mode. A Warning W8:BOLUS CANCELLED or a Warning W6: TBR CANCELLED isdisplayed.Press f twice to confirm and turn off the alert. Thealerts are recorded in the alarm history.See chapter 8 Warning W6: TBR CANCELLED andWarning W8: BOLUS CANCELLED.Make sure that the cancellation was deliberate and thenprogram a new Temporary Basal Rate (and / or anExtended or Multiwave Bolus), if needed.145

7.3 Your insulin pump and waterc CautionImmediately inspect your pump if it is dropped. Do not useyour Accu-Chek Spirit Combo insulin pump if chips, cracksor other damages are visible. Otherwise water, dust, insulinor other foreign substances may enter your pump and couldresult in a malfunction.If you have questions or are not sure whether your pump hasbeen damaged, contact your local pump support (details oninside back cover).c CautionAvoid contact with water. Check daily that your Accu-ChekSpirit Combo insulin pump is not chipped, cracked or damagedin any way, and that the battery cover and the adapter arecorrectly closed. If the pump is chipped or cracked, water,dust, insulin, or other substances may enter your pump andlead to malfunction. Before any contact with water, disconnectand take off your pump.Disconnect and remove your pump before taking a bath, orgoing into a whirlpool, shower, or swimming pool. Avoidexposing your pump to high humidity, such as in a sauna, asthis could result in damage. To make it easy to remove yourpump, use disconnectable Accu-Chek infusion sets.146

77.3.1 Accidental contact with waterYour Accu-Chek Spirit Combo insulin pump is IPX8 waterproofwhen leaving the factory site. However hair-line cracks couldappear during use. Therefore we may only guarantee protectionagainst brief accidental water contact such as:jj Rainjj Water splashes while you are cycling, jogging or hikingjj Accidental immersion in the sink, washbasin or bathWhat to do after any water contactPut your pump into STOP mode, disconnect the pump from yourbody, and inspect it. Use a soft dry cloth to dry the outside of thepump, and check the battery compartment and the cartridgecompartment for water. If the battery compartment or cartridgecompartment are wet, turn your pump upside down to let thewater run out and let it air dry. Do not use warm air such as ahair dryer to dry the pump, as this could damage the pump’shousing. Do not reinsert the battery or the cartridge until thecompartments are completely dry. See section 7.5.1 Cleaningyour pump.Other liquidsYou do not have to worry about contact between your pump andperspiration or saliva. You must however check your pumpimmediately after contact with other liquids or chemicals such as:jj Cleaning solutionsjj Alcoholjj Beveragesjj Oil or FatIn case of contact with these substances, clean your pumpimmediately. See section 7.5.1 Cleaning your pump.c CautionAvoid any contact between your Accu-Chek Spirit Comboinsulin pump, the infusion set, and the connecting parts ofyour insulin pump with health and beauty items (for example:antiseptics, antibiotic creams, soaps, perfumes, deodorants,body lotions, or any other cosmetics). These substancescould discolour your pump or fog the display.147

7.4 Repair of your pumpc CautionDo not perform any servicing or repair on your pump. Do notuse any lubricants on the pump mechanism. If you havequestions, contact your local pump support (details on insideback cover).If you have problems with your pump, contact your local pumpsupport (details on inside back cover). Your local pump supportcan answer many questions and resolve many problems over thetelephone. You may be requested to return your pump to RocheDiagnostics for repair. For example, you may need to return yourpump if a Warning or Error could not be cleared by following theprocedures described in chapter 8 Warnings and Errors.When you return your pump, include the following:jj a description of the reason for returning your pumpjj your name and addressjj your daytime phone numberjj the serial number of your pumpjj any RMA (Return Material Authorization) number received fromyour local pump support.By returning your pump to Roche Diagnostics, you authorizeRoche Diagnostics to undertake any testing on your infusionpump that is needed for a proper inspection, and understandthat your pump may not be returned to you.(For the address, see inside the back cover.)If you have to ship your pump, carefully pack the pump and theused cartridge, battery, battery cover, adapter, and infusion setto avoid damage during transportation. Place your pump back inthe shipping case and put the case in a package that will not ripor tear. It is recommended to ship your pump using a companythat tracks the shipment for you.148

77.5 Maintaining your pump7.5.1 Cleaning your pumpThe best time to clean your pump is when you change thecartridge. Use a soft cloth to clean the outside of the pump. Ifnecessary, use a damp clean cotton cloth with water or, evena damp soapy water cloth. If these measures are not successful,contact your local pump support (details on inside back cover)for more instructions. Also see section 7.3.1 Accidental contactwith water.c CautionAlways remove the cartridge and adapter, and put your pumpin STOP mode while cleaning. Avoid pressing the keys of yourAccu-Chek Spirit Combo insulin pump during cleaning, as thismay accidentally change your settings. Do not use alcohol,solvents, strong detergents, bleaching agents, scouring padsor sharp instruments for cleaning, as they may damage thepump.7.5.2 BatteriesIt is important to change your battery regularly and to keep sparebatteries available. The life of any battery is affected by how youuse your Accu-Chek Spirit Combo insulin pump, your personalsettings, delivery rates, temperature, and other factors.For details see Appendix A for lifetime of battery.See section 1.4 Accessories and disposables or Appendix C formore information on recommended batteries.See section 2.2 Inserting the battery for instructions on how tochange your battery.149

7.6 Storing your pumpc CautionWhen your pump will not be in use for a long period of time, itmust be properly stored to prevent any subsequent malfunction.To store your pump, place it in STOP mode, then:jj Remove the battery to preserve the battery lifejj Remove the cartridgejj Insert the battery cover and the adapterjj Store your pump in its packaging7.7 Disposing of your pumpSince your Accu-Chek Spirit Combo insulin pump may come intocontact with blood during use, it may carry a risk of infection.Therefore it falls outside the scope of the European Directive2002 / 96 / EC and may not be disposed of with other electronicdevices. If you need to dispose of your Accu-Chek Spirit Comboinsulin pump, return it to Roche Diagnostics (address inside theback cover) for professional disposal.BatteryCorrectly dispose of empty batteries, recycling them whereverpossible.Storage conditionsTemperatureAir humidityBarometric pressure41 °F to 113 °F (+5 °C to +45 °C)5 to 85 % relative air humidity500 to 1060 mbarCartridge, Infusion set, Adapter, and AccessoriesDispose of these items in your normal household waste or, forthe batteries, at the usual recycling point. Remember to disposeof the introducer needle safely (using the needle container).To prevent injury to others, replace the needle protective coveror insert the needle of the infusion set into a disposable object,or put it in a hard-shell container.150

88 Warnings and ErrorsA safety system monitors and controls the function of yourAccu-Chek Spirit Combo insulin pump. This safety systemperforms more than 9 million safety checks every day. If itdetects a change from the pump’s normal state, it will trigger aWarning or an Error message. Beeps, vibrations, and messageson the pump screen indicate the cause of a Warning or Error.Warnings and Errors are the only way you can be quickly notifiedof any changes in your pump.c CautionCheck the pump display regularly during the day, and beforeyou go to sleep, and especially if you might not be able tohear the beeps or feel the vibrations for any reason.Your pump signals Warnings and Errors using beeps andvibrations. You can turn off either the beeps or the vibrations, butfor your safety you cannot turn off both at the same time for theinitial alarm signal.If you do not confirm a Warning or Error within 60 seconds, it willbe signalled again. Even when the beep is turned off or programmedat lower than maximum volume, the beep volume willrise to the loudest volume level if not confirmed. Both the beepand vibration will then continue at this level until confirmed.Notej The volume of the STOP-Warning is separate from theprogrammed beep volume and cannot be changed.It always occurs at the maximum level.jj Keylock is unlocked by the system each time a Warningor Error occurs.151

8.1 Confirming a Warning or ErrorWhen you confirm:W1: CARTRIDGE LOWE1: CARTRIDGE EMPTYW2: BATTERY LOWE2: BATTERY EMPTYW5: PUMP TIMERE5: END OF OPERATION,the symbol for that Warning or Error stays in the RUN screen orSTOP screen as a Reminder.Battery low symbolCartridge low symbolPump timer symbolKeylock symbolFor other Warnings or Errors, alarm information is cleared fromthe display but stays in the alarm history and the event memory.When a Warning or an Error occurs:jjPress f to turn off the beeps and vibrations. The Warning orError code stays on the display.jj As soon as you understand the reason for the Warning or Error,confirm by pressing f again.jj Take appropriate action, as necessary.jj If more than one Warning and /or Error occurs simultaneously,press f twice for each Warning or Error to confirm them andturn them off.jj After a Warning or Error, make sure that you switch your pumpback to RUN mode where appropriate.NoteWhen you use your pump together with the Meter you canalso snooze and confirm an incoming Warning or Errorwith the Meter. For further information see the Meter userinformation.152

88.2 List of Warningsw WarningAfter a Warning occurs, your Accu-Chek Spirit Combo insulinpump may be in STOP mode and insulin delivery may beinterrupted. In order to maintain insulin delivery, you must actimmediately according to the instructions given for each Errorcode, or put your Accu-Chek Spirit Combo insulin pump inRUN mode to continue the insulin delivery.Warning W1: CARTRIDGE LOWThe contents of the insulin cartridge have dropped to 20 units ofinsulin. Be prepared to replace the cartridge as soon as possible.The “cartridge low” symbol appears in the RUN or STOP screenas a Reminder until you change the cartridge.jjPress f twice to snooze and to confirm the Warning. Changethe cartridge before it is empty.jj If necessary, put your pump in RUN mode.See section 3.5 Changing the cartridge and infusion set.153

Warning W2: BATTERY LOWThe battery power is low. Be prepared for a battery change assoon as possible. The battery low symbol appears in the RUN orSTOP screen as a Reminder until you change the battery.jjPress f twice to snooze and to confirm the Warning.Warning W3: REVIEW TIMEThe pump settings and history data are saved in memoryregardless of power loss. However, it may be necessary to setthe time and date again.jjPress f twice to snooze and to confirm the Warning.jj Replace the battery as soon as possible. Failure to change thebattery within a few hours of receiving the Warning couldresult in additional Error messages.jj If necessary, put your pump in RUN mode.jj Review the time and date and correct them, if they are wrong.jj If necessary, put your pump in RUN mode.See section 2.4 Setting the time and date.See section 1.4 Accessories and disposables on recommendedbatteries. See section 2.2 Inserting the battery for instructions onhow to change the battery.154

8Warning W4: LIFETIME WARNINGThe pump is coming to the end of its lifetime. Contact your localpump support (see inside back cover).jjPress f twice to snooze and to confirm the Warning.Warning W5: PUMP TIMER (backup pumps only)Your pump’s operating time will expire soon. When the WarningW5: PUMP TIMER occurs, your pump has a remaining operatingtime of 30 days.jjPress f twice to snooze and to confirm the Warning.jj Put your pump in RUN mode if necessary.jj Put your pump in RUN mode.jj Go to the MY DATA menu on your pump.155

jj Move to the PUMP TIMER screen. The days until the pumptimer expires are shown.Warning W6: TBR CANCELLED (Temporary Basal RateCancelled)A temporary increase or decrease in the basal rate has beencancelled.jjPress f twice snooze and to confirm the Warning.When the PUMP TIMER reaches zero, the pump will change toSTOP mode and will no longer operate. An Error, E5: END OFOPERATION, will appear on the display. Contact your local pumpsupport (details on inside back cover) to discuss the options forfurther use of your Accu-Chek Spirit Combo insulin pump.NoteThe Warning W5: PUMP TIMER and the Error E5: END OFOPERATION are based on running time (the total time thepump is in RUN mode), and not on calendar years.See section 5.4.5 Viewing the time remaining.jj If necessary, put your pump in RUN mode.jj Make sure that the cancellation was intended and thenprogram a new Temporary Basal Rate if necessary.156

8Warning W7: TBR OVER (Temporary Basal Rate Over)A Temporary Basal Rate has ended. The original basal rate(100 %) will resume automatically once the Warning hasoccurred.jjPress f twice to snooze and confirm the Warning.Warning W8: BOLUS CANCELLEDA bolus was cancelled during the start delay or after deliverybegan.jjPress f twice to snooze and to confirm the Warning.jjDecide whether a further Temporary Basal Rate change isrequired. If necessary, program a new Temporary Basal Rate.jj If necessary, put your pump in RUN mode.jj Make sure that the cancellation was intended and thenprogram a new bolus if needed.NoteThe actual bolus amount that was delivered before thecancellation can be reviewed in the bolus history. Seesection 5.4.1 Viewing your bolus history.157

Warning W9: LOANTIME WARNING (loan pumps only)The pump is coming to the end of its loan period. In the MY DATAmenu, check the remaining loan time in the PUMP TIMER menu.Make sure that you arrange for the replacement of the pumpwithin the scheduled loan time.jjPress f twice to snooze and to confirm the Warning.Warning W10: BLUETOOTH FAULTYou need to re-do the pairing procedure for the Accu-ChekSpirit Combo insulin pump and Meter.See section 6.3 Pairing your pump with the Meter.jjPress f twice to snooze and to confirm the Warning.jj Put your pump in RUN mode if necessary.jj Go to the MY DATA menu on your pump.jj Move to the PUMP TIMER screen. The days until the loantimeexpires are shown.jj Put your pump in RUN mode if necessary.NoteThis setting is country-specific and may not be visible onyour pump.158

88.3 List of Errorsw WarningAfter the occurrence of an Error, your Accu-Chek Spirit Comboinsulin pump is in STOP mode and insulin delivery is interrupted.In order to maintain insulin delivery, you must actimmediately according to the instructions given for eachError.Error E1: CARTRIDGE EMPTYThe insulin cartridge is empty. You must change it immediately.jjPress f twice to snooze and to confirm the Error.jj Disconnect or remove the infusion set from the infusion site.jj Change the cartridge and prime the infusion set.jj Reconnect the infusion set or insert a new one.jj Put your pump in RUN mode.See section 3.5 Changing the cartridge and infusion set.Error E2: BATTERY EMPTYThe battery is empty. You must replace it immediately.w WarningAfter inserting a new battery, always check that the time anddate of your Accu-Chek Spirit Combo insulin pump are setcorrectly. Incorrect programming of the time and /or date maycause incorrect insulin delivery. If you, your doctor orhealthcare team store and analyse your therapy dataelectronically and the time and date of the devices used arenot set identically, the resulting data might not be meaningful.159

jjPress f twice to snooze and to confirm the Error.Error E3: AUTOMATIC OFFAutomatic Off is a safety feature that stops insulin delivery andtriggers an Error E3: AUTOMATIC OFF if no keys are pressedwithin a programmed time period in RUN mode.jjPress f twice to snooze and to confirm the Error.jj Replace the battery.jj Put your pump in RUN mode.NoteYour pump stores the settings you saved before thebattery power ran out. If your pump is without power formore than one hour, check that the time and date arestill correct.See section 1.4 Accessories and disposables on recommendedbatteries. See section 2.2 Inserting the batteryfor instructions on how to change your battery.jj Put your pump in RUN mode.160

8Error E4: OCCLUSIONw WarningIf the Error E4: OCCLUSION occurs, immediately check yourblood glucose level, and then check again about 2 hours later,as insulin delivery has been interrupted. If your blood glucoselevel is high, take appropriate action according to yourdoctor’s or healthcare team’s instructions.Insulin was not delivered. This may be due to:jj a blocked infusion setjj a damaged cartridgejj a dirty or damaged piston rodIf an Error E4: OCCLUSION (blockage) occurs, follow thesteps listed below:jjPress f twice to turn off and to confirm the Error.jj Disconnect or remove the infusion set from your infusion site.jjChange the infusion set and prime it, as explained in chapter 2.jj Put your pump in RUN mode.161

In rare cases, the cartridge itself can be the cause of theocclusion. If an Error E4: OCCLUSION occurs again, youmust change the cartridge. Follow the steps listed below:jjPress f twice to turn off and to confirm the Error.jj Disconnect or remove the infusion set from your infusion site.jj Change the cartridge and prime the infusion set, as explainedin chapter 2.jj Reconnect or insert a new infusion set at your infusion site.jj Put your pump in RUN mode.If the Error E4: OCCLUSION occurs again, prime your pumpwithout a cartridge. Follow the steps listed below:jjPress f twice to turn off and to confirm the Error.jj Disconnect or remove the infusion set from your infusion site.jj Remove the cartridge, adapter and infusion set from your pump.jjCarry out the Infusion set priming function (See section2.8 Priming the infusion set) without the cartridge, adapter,and infusion set inserted.jj Insert a new cartridge with the adapter and infusion setconnected.jj Prime the infusion set.jj Reconnect the or insert a new infusion set at your infusionsite.jj Put your pump in RUN mode.If the Error E4: OCCLUSION continues to occur, use thealternative therapy plan provided by your doctor orhealthcare team. Contact your local pump support (detailson inside back cover) for more assistance.162

8Error E5: END OF OPERATION (backup pumps only)The pump timer of your Backup pump has reached zero. Thepump changes to STOP mode and will no longer operate. AnError E5: END OF OPERATION appears on the display. Before thisError occurs, a Warning W5: PUMP TIMER will remind you toreplace your pump soon. If necessary, use the alternative therapyplan provided by your doctor or healthcare team.NoteThe Warning W5: PUMP TIMER and the Error E5: END OFOPERATION are based on running time (the total timethe pump is in RUN mode) and not on calendar years.jjPress f twice to snooze and to confirm the Error.jj Contact your local pump support (see inside back cover)to discuss the options for further use of the Accu-ChekSpirit Combo insulin pump.163

Error E6: MECHANICAL ERRORA mechanical Error has been discovered during a routineautomatic system check and insulin delivery has stopped.jjPress f twice to snooze and to confirm the Error.jj Reconnect the infusion set at your infusion site.jj Put your pump in RUN mode.If the Error E6: MECHANICAL ERROR occurs again, use thealternative therapy plan provided by your doctor or healthcareteam. Contact your local pump support (details on inside backcover) for more assistance.jj Remove or disconnect the infusion set from your infusion site.jj Remove the cartridge, adapter, infusion set, and battery fromyour pump. Insert a new battery.jj Install a new cartridge and infusion set. It is essential thatyou rewind the piston rod. (See section 2.7 Inserting thecartridge). Prime the infusion set (See section 2.8 Primingthe infusion set).Error E7: ELECTRONIC ERRORAn electronic Error has been discovered during a routineautomatic system check and insulin delivery has stopped.NoteYou cannot turn off and confirm an Error E7: ELECTRONICERROR by pressing f. You must remove the batteryinstead.164

8jj Remove or disconnect the infusion set from your infusion site.jjReplace the battery in the pump (See section 2.2 Inserting thebattery).jj Prime the infusion set.jj Reconnect the infusion set at your infusion site.jj Put your pump in RUN mode.After an Error E7: ELECTRONIC ERROR always check yoursettings like e.g. basal rate profile, time and date.If the Error E7: ELECTRONIC ERROR occurs again, contact yourlocal pump support (details on inside back cover) for assistance.Use the alternative therapy plan provided by your doctor orhealthcare team.Error E8: POWER INTERRUPTA power interrupt Error occurs when you insert a new batterywithout first placing the pump in STOP mode. See section2.2 Inserting the battery for instructions on how to change thebattery. The Error can also occur if the pump has been dropped.In this case, see section 7.2.1 What to do if you drop your pump.jjPress f twice to snooze and to confirm the Error.jj Your pump goes into STOP mode.jj Check the time and date and correct them if they are wrong.See section 2.4 Setting the time and date.jj Put your pump in RUN mode. Program a new bolus and /orTemporary Basal Rate if necessary. See chapter 4 Boluses andTemporary Basal Rates.If an Error E8: POWER INTERRUPT occurs during programming,check your settings.165

Error E9: END OF OPERATION (loan pumps only)The pump timer of your Loaner pump has reached zero. Thepump changes to STOP mode and will no longer operate. AnError E9: END OF OPERATION appears on the display. Beforethis Error occurs, a Warning W9: LOANTIME WARNING willremind you to replace your pump soon. If necessary, use thealternative therapy plan provided by your doctor or healthcareteam.jjPress f twice to snooze and to confirm the Error.NoteThis setting is country-specific and may not be visible onyour pump.The Warning W9: LOANTIME WARNING and the Error E9:END OF OPERATION are based on running time (the totaltime the pump is in RUN mode) and not on calendaryears.Error E10: CARTRIDGE ERRORThe CARTRIDGE CHANGE function was not correctly performed.jjPress f twice to snooze and to confirm the Error.jj Contact your local pump support (details on inside back cover)to discuss the options for further use of the Accu-Chek SpiritCombo insulin pump.jj Remove or disconnect the infusion set from your infusion site.jj Remove the cartridge.jjReinsert the cartridge. (See section 2.7 Inserting the cartridge)166

8jj Prime the infusion set.jj Reconnect the infusion set at your infusion site.jj Put your pump into RUN mode.jj If the Error E10: CARTRIDGE ERROR occurs during therewinding of the piston rod, insert a new battery in the pumpand repeat the procedure.Error E11: SET NOT PRIMEDThe cartridge has been changed but the infusion set has notbeen primed. The Error will be displayed when you try to put yourpump in RUN mode.See sections 3.5 Changing the cartridge and infusion set and2.8 Priming the infusion set.w WarningNever prime an infusion set that is connected to your body.You risk uncontrolled insulin delivery into your body. Alwaysfollow the instructions provided with your infusion set.jjPress f twice to snooze and to confirm the Error.jj Remove or disconnect the infusion set from your infusion site.jjPrime the infusion set (See section 2.8 Priming the infusion set).jj Reconnect the infusion set at your infusion site.jj Put your pump in RUN mode.167

Error E12: DATA INTERRUPTEDjjPress f twice to snooze and to confirm the Error.c CautionIf infrared data transfer between your pump and a compatibledevice is disrupted in any way, the configuration may beincomplete and the Error E12: DATA INTERRUPTED will occur.The data transfer must be successfully completed before youcan put your Accu-Chek Spirit Combo insulin pump into RUNmode.Data transfer between your pump and the PC was interruptedbefore it was completed.jj Restart the data transfer.Before you can put your pump in RUN mode, the data transfermust have been successfully performed.See section 5.5 Transferring your data to a computer.168

8Error E13: LANGUAGE ERRORThe language setting needs to be checked.jjPress f twice to snooze and to confirm the Error.jjFollow the steps in section 5.6 Pump settings to change thelanguage.jj Put your pump in RUN mode.169

8.4 List of RemindersReminder R1: ReminderA Reminder has been programmed on the pump.jjPress f twice to snooze and to confirm the Reminder.Reminder R2: END OF WARRANTYThe 4-year warranty covering your insulin pump has expired.For any questions and concerns about the warranty, contact yourlocal pump support (see inside back cover).jjPress f twice to snooze and to confirm the Reminder.jj If necessary, put your pump in RUN mode.NoteIf you have set the Reminder occurrence to EVERY DAY,the same Reminder occurs every 24 hours. Turn theReminder function OFF if you do not want the alarm to gooff again at that same time every day. See section5.9 Setting a Reminder.jj Put your pump in RUN mode if necessary.170

99 TroubleshootingThis chapter describes problems that may occur when usingyour Accu-Chek Spirit Combo insulin pump. Any problems thatgenerate a Warning or Error are described in chapter 8.NoteThe solutions provided in this chapter will normally enableyou to resolve the problem and continue with your pumptherapy. However, if the recommended action does notresolve the problem, or if you have any concerns, do nothesitate to contact your doctor or healthcare team.Note Troubleshooting information relating to the Bluetooth ®connection between the Meter and the Accu-ChekSpirit Combo insulin pump is included in chapter 6 Usingthe Accu-Chek Spirit Combo insulin pump with the Meter.Also refer to the documentation (Owners booklet) comingwith the Meter.Although your pump has an internal security check system, itcannot for example detect if your infusion set is leaking or if theinsulin you are using has lost its efficacity. These problems canresult in a rapid rise in your blood glucose level. Therefore, it isessential to check your pump and blood glucose level during theday.171

9.1 Therapy-related issuesMany factors – such as alcohol consumption, medication, decreased activity, illness and stress – can affect your blood glucose level.Contact your doctor or healthcare team for advice on how to manage these, or any other, therapy-related issues.ProblemIndividual characters, numbers, or symbols on the displayare shown incompletely or not at all.Your Accu-Chek Spirit Combo insulin pump does not beepor vibrate.The self-test is not completed correctly (after an Error E7:ELECTRONIC ERROR).Insulin delivery is incorrect due to inaccurate time setting.Insulin delivery is incorrect due to incorrect basal rateprogramming.Recommended ActionContact your local pump support (details on inside back cover).Check that the beep volume and alarm signals are turned on. Check thebattery and change it if necessary. If the pump still does not beep orvibrate, contact your local pump support (details on inside back cover).Remove the battery, wait a few seconds, and insert it again. If theself-test is still not completed correctly, contact your local pumpsupport (details on inside back cover).If the time setting is inaccurate, the correct hourly basal rate cannot bedelivered. Check and reset the time if necessary. Perform the samecheck whenever you change the battery.Review any changes that you have made to your basal rate programming,to ensure that you are using the correct basal rate profile.172

9ProblemThere are air bubbles in the cartridge and /or infusion set.Recommended ActionCheck your blood glucose level.In the cartridge: Disconnect the infusion set from the headset andre-prime the infusion set. If the air bubbles remain, replace thecartridge. Always fill the cartridge with insulin that is at room temperature.In the infusion set: Disconnect from the headset and prime your infusionset. Reconnect the headset and ensure that all connections are tight andsecure.The cartridge is empty.Replace the cartridge. (Cartridges are for single use only.)The infusion set is disconnected or dislodged.Check your blood glucose level. Make sure that all the connections aretight. Inspect the connections for leaking insulin. Change your infusionset and infusion site.173

ProblemThere is a leak in the system.There is an occlusion (blockage) in the system.Priming was not completed (E11 or air bubbles in infusionset).Recommended ActionCheck your blood glucose level. Check for leaking insulin at all theconnection points and on the skin. Change the infusion set, the infusionsite, the cartridge and the adapter.Check your blood glucose level. Follow the instructions inchapter 8 Error E4: OCCLUSION.Re-prime the infusion set. Always prime until a bubble-free insulin flowemerges from the tip of the needle. Ensure that the tubing is free of air.174

Appendix A: Technical DataAGeneral Technical DataMaximum dimensions(without adapter)WeightPump casingApprox. 82.5 × 56 × 21 mm(3.2 × 2.2 × 0.8 inches)jj an empty insulin pump: approx. 80 g (2.8 ounces)jj insulin pump inclusive battery, full plastic cartridge and infusion set:approx. 110 g (3.9 ounces)Shock- and scratch-resistant plastic, resistant to pharmaceuticals, all edges roundedTemperature ranges*Air humidityDuring operation: +5 to +40 °C (+41 to +104 °F)Storage in its shipping case: +5 to +45 °C (+41 to +113 °F)During Transport: –20 to 50 °C (–4 to +122 °F)During operation: 20 to 90 % relative humidityStorage in its shipping case: 5 to 85 % relative humidityDuring Transport: 5 to 95 % relative humidity175

General Technical DataBarometric pressurePower supplyLifetime of batteryData storage timeDuring operation: 50 to 106 kPa (500 to 1060 mbar)During Transport or storage in its shipping case: 50 to 106 kPa (500 to 1060 mbar)One 1.5 volt AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 volt rechargeable NiMHAA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Use only abattery charger officially recommended by the battery manufacturer. Do not use carbon zincor nickel cadmium (NiCd) batteries.If used in a typical usage pattern (50 U / day using U100 insulin; operating temperature23 °C ±2 °C [73 °F ±4 °F]) the battery life is approximately:Alkaline: 70 days for Bluetooth ® off; 30 days for Bluetooth ® onLithium: 200 days for Bluetooth ® off; 80 days for Bluetooth ® onNiMH: 100 days for Bluetooth ® off; 40 days for Bluetooth ® onThe time and date are safely stored in the memory for about 1 hour after the battery hasbeen removed. Other insulin pump settings (the hourly basal rates, remaining cartridgecontent, bolus increments and active user menu) and the event memory (bolus history,history of daily insulin totals, Temporary Basal Rate history, alarm history) are saved,regardless of battery voltage and the time your insulin pump has been without a battery.176

AGeneral Technical DataDelivery1 / 20 of the current hourly basal rate in 3 minute intervals.Basal rate Min. 0.05 U / h, max. 50 U / h. There are 24 hourly basal rates adjustable in 0.01(up to 1.00 U / h, 0.05 (up to 10.0 U / h) and 0.1 (up to 50.0 U / h) unit increments.BolusTemporary Basal RateThe max. bolus amount per delivery is 50 insulin units. The bolus amount for the QuickBolus is adjustable in increments of 0.1, 0.2, 0.5, 1.0 and 2.0 units. For the Standard Bolus,Extended Bolus and Multiwave Bolus, the amount is adjustable in fixed increments of0.1 units. The duration of the Extended Bolus and the Multiwave Bolus is adjustable inintervals of 15 minutes (15 minutes up to 12 hours).Adjustable in 10 % increments, 0 – 90 % for decreases, 110 – 250 % for increases. Theduration is adjustable in 15 minute intervals, up to a maximum of 24 hours. The lastprogrammed duration is given by default for the next Temporary Basal Rate changeprogrammed.177

General Technical DataMaximum time for an ErrorE4: OCCLUSION**Maximum volume before ErrorE4: OCCLUSION**Maximum pressureFlow (delivery rate)Plastic cartridges:jj at medium basal rate 1.0 U / h: ≤ 2 hjj at minimum basal rate 0.05 U / h: ≤ 24 hAventis Insuman Infusat glass cartridges***:jj at medium basal rate 1.0 U / h: ≤ 8 hjj at minimum basal rate 0.05 U / h: ≤ 120 hPlastic cartridges: ≤ 1.5 U.Aventis Insuman Infusat glass cartridges***: ≤ 5.0 U400 kPa (4.0 bar), for plastic and Aventis Insuman Infusat glass cartridges*** and infusionsets.During infusion set priming and bolus 0.2 U / sec.Maximum quantity delivered ata single fault conditionCartridge≤ 1.0 UAccu-Chek Spirit 3.15 ml Cartridge System and Accu-Chek 3.15 ml Plastic Cartridge with aluer connection. Aventis Insuman Infusat cartridges*** have been evaluated and approvedfor use with the Accu-Chek Spirit Combo insulin pump.178

AGeneral Technical DataInfusion setsData transferAccu-Chek infusion sets with a luer-lock connector.Accu-Chek Infusion sets are PCV and latex free.Infrared interfaceSafety systemIPX8Alert system, beeps, information on the display, vibrations, dual microprocessors. Yourinsulin pump is controlled by 2 microprocessors. The safety concept is based on oneprocessor (supervisor processor) supervising the other (main processor). Whenever a defector fault occurs in the main processor, it is identified by the supervisor processor. The motoris immediately switched off and an Error E7: ELECTRONIC ERROR occurs. Conversely, themain processor can also determine at any time whether the supervisor is working correctly.Protected against the effects of temporary immersion in water under standardized conditions(up to 60 minutes and 2.5 meters [8 feet]).* See the instructions for use of the insulin you are using for information on the acceptable temperature range for storage and handling.** Determined using measurement methods according to IEC 60601-2-24-1998.*** Insuman ® Infusat produced by Aventis Pharma Deutschland GmbH is a registered trademark of the sanofi-aventis group.The Aventis Insuman ® Infusat cartridgehas not been licensed for sale in Canada.179

Technical standardsTable 201: Electromagnetic emissionGuidance and manufacturer’s declaration – electromagnetic emissionsThe Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user of theAccu-Chek Spirit Combo should ensure that it is used in such an environment.Emission test Compliance Electromagnetic environment – guidanceRF emissionsCISPR 11RF emissionsCISPR 11Harmonic emissionsIEC 61000-3-2Voltage fluctuations / flickeremissionsIEC 61000-3-3Group 2Class BNot applicable –Not applicable –The Accu-Chek Spirit Combo must emit electromagnetic energy inorder to perform its intended function. Nearby electronic equipmentmay be affected.The Accu-Chek Spirit Combo is suitable for use in all establishments,including domestic establishments and those directlyconnected to the public low-voltage power supply network thatsupplies buildings used for domestic purposes.180

ATable 202: Electrostatic discharge (ESD) and power frequency magnetic fields (all devices)Guidance and manufacturer’s declaration – electromagnetic immunityThe Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user ofAccu-Chek Spirit Combo should assure that it is used in such an environment.Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidanceElectrostaticdischarge (ESD)IEC 61000-4-2± 8 kV contact± 15 kV air± 8 kV contact± 15 kV airFloors should be wood, concrete or ceramic tile. If floorsare covered with synthetic material, the relative humidityshould be at least 30 %.Electrical fasttransient / burstIEC 61000-4-4± 2 kV for powersupply linesNot applicableSurgeIEC 61000-4-5± 1 kV line to line± 2 kV line to earthNot applicable181

Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidanceVoltage dips, shortinterruptions and voltagevariations on powersupply linesIEC 61000-4-11< 5 % UT (0,5 cycle)40 % UT (5 cycles)70 % UT (25 cycles)< 5 % UT for 5sNot applicableNoteUT is the A.C. mains voltage prior to application of the test level.Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidancePower frequency(50 / 60 Hz)magnetic fieldIEC 61000-4-8400 A / m 400 A / m Power frequency magnetic fields should be at levelscharacteristic of a typical location in a typical commercialor hospital environment.* Test levels acc. to IEC / EN 60601-2-24182

ATable 203: Immunity electromagnetic fields (life-supporting devices)Guidance and manufacturer’s declaration – electromagnetic immunityThe Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user of theAccu-Chek Spirit Combo should assure that it is used in such an environment.Electromagnetic environment – guidancePortable and mobile RF communications equipment should be used no closer to any part of the Accu-Chek Spirit Combo, includingcables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Immunity test standard IEC 60601 test level Compliance level Recommended separation distance c)Conducted RFIEC 61000-4-6Radiated RFIEC 61000-4-3Radiated RFIEC 61000-4-33 Vrms150 kHz to 80 MHz10 V / m80 MHz to 800 MHz10 V / m800 MHz to 2,5 GHzV1 = 10 Vrms150 kHz to 80 MHz d = 1.2 P 150 kHz to 80 MHzE1 = 10 V / m80 MHz to 800 MHz d = 1.2 P 80 MHz to 800 MHzd)E2a = 2 V / m for2.3 GHz to 2.5 GHze)E2b = 10 V / m for800 MHz to 2.3 GHzand 2.5 to 2.7da = 11.7 Pdb = 2.3 P2.3 GHz to 2.5 GHz800 MHz to 2.3 GHz and2.5 GHz to 2.7 GHz183

Guidance and manufacturer’s declaration – electromagnetic immunityWhere P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is therecommended separation distance in metres (m).Field strengths from fixed RF transmitters. as determined by an electromagnetic site survey, a) should be less than the compliancelevel in each frequency range. b)Interference may occur in the vicinity of equipment marked with the following symbol:NoteNoteAt 80 MHz and 800 MHz, the higher frequency range applies.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fromstructures, objects and people.a )Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radiobroadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, anelectromagnetic site survey should be considered. If the measured field strength in the location in which the Accu-Chek Spirit Combo is used exceeds theapplicable RF compliance level above, the Accu-Chek Spirit Combo or the device, which contains it should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as re-orienting or relocating the device containing the Accu-Chek Spirit Combo.b ) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V / m.c )d )e )Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.Exclusion band for Bluetooth ® ISM 2.4 GHz communication channelCompliance band for the system equipment184

ATable 205: Recommended separation distances (life-supporting devices)Recommended separation distances between portable and mobile RF communications equipment and theAccu-Chek Spirit Combo.The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of the Accu-Chek Spirit Combo can help prevent electromagnetic interference by maintaining a minimumdistance between portable and mobile RF communications equipment (transmitters) and the Accu-Chek Spirit Combo as recommendedbelow, according to the maximum output power of the communication equipment.Rated maximum outputpower of transmitter(W)Separation distance according to frequency of transmitter (m)150 kHz to 80 MHzd = 1.2 P80 MHz to 800 MHzd = 1.2 P800 MHz to 2.3 GHzdb = 2.3 P0.01 12 cm 12 cm 23 cm 118 cm0.1 38 cm 38 cm 73 cm 373 cm1 1.2 m 1.2 m 2.3 m 11.8 m10 3.8 m 3.8 m 7.3 m 37.3 m100 12 m 12 m 23 m 118 m2.3 GHz to 2.5 GHzda = 11.7 PFor transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equationapplicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.185

NoteNoteNoteAt 80 MHz and 800 MHz, the separation distance for thehigher frequency range applies.These guidelines may not apply in all situations. Electromagneticpropagation is affected by absorption andreflection from structures, objects and people.An additional factor of 10 / 3 is used in calculating therecommended separation distance to decrease thelikelihood that mobile / portable communications equipmentcould cause interference if it is inadvertenlybrought into the vicinity of the user.186

AAccuracy of flow rate for bothAccu-Chek 3.15 ml Plastic Cartridgesand Accu-Chek Spirit 3.15 ml CartridgeSystemTrumpet curve plotted from data after the end of thestabilization periodThe trumpet curve shows the accuracy of the delivery rate inrelation to the observation period.20minimum measured variationmaximum measured variationoverall percentage Error15percentage Error of flow (%)1050–5–103.810.82 0.22–0.18A= –1.38–3.17 –2.58 –2.18–8.17–0.81–1.971.021.79–15–200 60 120 180 240 300 360 420 480 840 600 660 720 780 840 900 960observation window duration (min)The maximum deviation of the delivered amount (overall meanpercentage flow Error) for U100 insulin is ≤ ± 5 %*. * The measurements were made at a medium basal rate of 1.0 U / haccording to IEC 60601-2-24:1998 with an Accu-Chek TenderLink infusionset 17 / 110 at room temperature.187

Start-up graph over the stabilization periodThe start-up graph shows changes in the flow rate over thestabilization time.0.012real flowtarget flow0.010flow rate (ml / h)0.0080.0060.0040.0020.01 ml is equivalentto 1IU (U100 insulin)0.0000 120 240 360 480 600 720 840 960 1080 1200 1320 1440time (min)188Influence of height on delivery accuracyThe maximum deviation of the delivered amount (overall meanpercentage flow Error) for U100 insulin is ≤ ± 10 %* where yourAccu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3 feet)above / below the infusion site.BolusFor U100 insulin the maximum deviation of a maximum bolus is≤ ± 5 % and the maximum deviation of a minimum bolus is≤ ± 30 %**.* The measurements were made at a medium basal rate of 1.0 U / haccording to IEC 60601-2-24:1998 with an Accu-Chek TenderLink infusionset 17 / 110 at room temperature.** The measurements were made according to IEC 60601-2-24:1998 with aAccu-Chek TenderLink infusion set 17 / 110 at room temperature.

Appendix B: Configuration parametersBBasal rateHourly basal rate + max. TBR(hourly basal rate combined with temporarybasal rate, max. increase)Hourly basal rates incrementTypical range available onthe pump and standardparameter settings*Maximum parameterrange adjustable with theAccu-Chek PC ConfigurationSoftware62.5 U / h max. amount: 0 – 250.0 U / h0.01 (up to 1.00 U / h),0.05 (up to 10.0 U / h) and0.1 (up to 50.0 U / h) 0.0, 0.05 U / h– 50.0 U / hHourly basal rates 25.0 U / h max. amount: 0 – 50.0 U / hTemporary Basal RateTBR increases or decrease in increments ofTBR durationTBR duration incrementsBasal rate profiles availableBasal rate lock0 – 250 %10 %max. 24 h15 min5off0 – 500 %10 %15 min – 50 h15 min, 30 min, 1 h1 – 5on or off* Note: These factory settings may vary in some countries and depend on thechanges you, your doctor or healthcare team make using your insulin pump orpump programming software for healthcare professionals.189

Typical range available onthe pump and standardparameter settings*Maximum parameterrange adjustable with theAccu-Chek PC ConfigurationSoftwareBolusBolus amount per bolus delivery 25.0 U max. amount: 0 – 50.0 Ubolus amount increments for Quick Bolusbolus amount increments for Standard Bolusbolus duration (Extended Bolus, Multiwave Bolus)bolus duration increments0.5 U0.1 Umax. 12 h15 min0.1, 0.2, 0.5, 1.0 or 2.0 U15 min – 50 h15 min, 30 min, 1 hPrime volume 25.0 U max. amount: 0 – 50.0 UDisplay orientationDisplay contrastUser menusVolumes (for beeps)Alarm signals turned onstandard or inverted7 steps3 (STANDARD, ADVANCED orCUSTOM)off, 4 stepsbeeps, vibrations or both190

BBattery typeKeylockTypical range available onthe pump and standardparameter settings*AA (LR6) ALKALINE, AA (FR6)LITHIUM or AA (HR6) NiMHrechargeable batteryturned on or offAutomatic off turned on (1 – 24 h) or off (0 h)ReminderTime formatDate formatBluetoothturned on or offwhen on: once or every day’soccurrenceEuropean (24 h) orAmerican (12 h, am / pm)European (dd.mm.yy) orAmerican (mm / dd / yy)on or offMaximum parameterrange adjustable with theAccu-Chek PC ConfigurationSoftware* Note: These factory settings may vary in some countries and depend on thechanges you, your doctor or healthcare team make using your insulin pump orpump programming software for healthcare professionals.191

Appendix C: Sterile products and accessoriesCartridgesAccu-Chek infusion setsNameAccu-Chek Spirit 3.15 mlCartridge SystemAccu-Chek 3.15 ml PlasticCartridgeAventis Insuman InfusatPrefilled 3.15 ml GlassCartridges* (U100)CommentsPlastic cartridges are single-useitems only. Do not re-use cart ridges.Refer to the instructions for useof the insulin you are using forinformation on the acceptabletemperature range for storage andhandling.* Insuman ® Infusat produced by Aventis Pharma Deutschland GmbH, a memberand brand of the sanofi-aventis group. The Aventis Insuman ® Infusat cartridgehas not been licensed for sale in Canada.NameAccu-Chek RapidLinkAccu-Chek Rapid-D LinkAccu-Chek TenderAccu-Chek TenderLinkAccu-Chek FlexLinkAccu-Chek FlexLink PlusAccu-Chek UltraflexCommentsAll Accu-Chek infusion sets areavailable in various tubing andcannula lengths. All Accu-Chekbranded infusion sets arecompatible with the Accu-ChekSpirit Combo insulin pump.Discuss with your doctor and /orhealthcare team to find theinfusion set that fits you best.For recommendations on how longyou may use the same infusion setsee the information materialprovided with this product.192

CAccessoriesNameCommentsNameCommentsAdapterBattery CoverBatteriesOne 1.5 volt AA (LR6)Alkaline or AA (FR6)Lithium battery with aminimum capacity of2500 mAh.Rechargeable BatteriesOne 1.2 volt AA (HR6)NiMH rechergeable batterywith a minimum capacityof 2500 mAh.Adapter and Battery Cover are partof the Accu-Chek Spirit ComboService Pack and Accu-ChekSpirit Combo Service Pack small.Replace your adapter and batterycover every 2 months.For battery lifetime see p. 176Lifetime of batteryFor battery lifetime see p. 176Lifetime of batteryRechargeable batteries are notprovided by Roche Diagnostics.Use only a battery chargerofficially recommended by thebattery manufacturer.Carrying SystemsAccu-Chek PCConfiguration SoftwareAccu-Chek Spirit ComboQuick Reference GuideAll Accu-Chek Spirit Combo andAccu-Chek Spirit Carrying systemsare compatible with the Accu-ChekSpirit Combo insulin pump. RocheDiagnostics offers a wide range ofcarrying system solutions to bestfit your lifestyle.Check with your local pumpsupport for the availability ofappropriate pump programmingsoftware.This is a convenient pocket sizereference that you may take withyou to assist with your insulinpump questions.193

Appendix D: AbbreviationsAbbreviationMeaningAbbreviationMeaningapprox.BRBRPhIECincl.IRApproximatelyBasal RateBasal rate profileHour (s)International Electrotechnical CommissionInclusive or includingInfraredNiMHrel.sec.TBRUU / hNickel Metal Hydrid (used with rechargeablebatteries)RelativeSecondsTemporary Basal RateSee I.U.Amount of International Units of insulindelivered per hourI.U., UkPaLCDLEDInternational Units in context with biologicaleffectiveness of certain insulin amountKilo pascalsLiquid Crystal DisplayLight Emitting Diode for infrared communicationwith e.g. a PCU100dd.mm.yymm.dd.yyThis is the insulin concentration. Eachmillilitre of liquid contains 100 InternationalUnits of insulinEuropean date format:day.month.yearAmerican date format:month.day.year194

Appendix E: Beeps and melodiesEAcoustic SignalsAll of the functions of the Accu-Chek Spirit Combo insulin pumpare supported by acoustic signals. The acoustic signals arebeeps.SoundFunctionDuration for very short sound = 31.25 ms ±20 %Duration for short sound = 62.5 ms ±20 %Duration for medium sound = 93.75 ms ±20 %Duration for long sound = 125.0 ms ±20 %Duration for short pause = 125.0 ms ±20 %Duration for medium pause = 218.75 ms ±20 %Duration for long pause = 500.0 ms ±20 %UP KEYFrequency: 3131 Hz ±5 %Duration: Short soundSoundFunctionDOWN KEYFrequency: 2486 Hz ±5 %Duration: Short soundMENU KEYFrequency: 2820 Hz ±5 %Duration: Short soundNAVIGATION BACKWARDS(MENU + UP KEY)Frequency: 2763 Hz ±5 %Duration: Short soundEXECUTE FUNCTION (CHECK KEY)Frequency: 2090 Hz ±5 %, 2486 Hz ±5 %Duration: 2 × short soundCANCEL FUNCTIONFrequency: 2486 Hz ±5 %, 2090 Hz ±5 %Duration: 2 × short sound195

SoundFunctionSoundFunctionBASE STATE RUN (KEYS UNLOCKED)Frequency: 2789 Hz ±5 %Duration: Short sound, short pause,short sound, short pause,short soundBASE STATE RUN (KEYS LOCKED)Frequency: 2763 Hz ±5 %Duration: Short sound, short pause,short sound, short pause,short soundBASE STATE STOP (KEYS UNLOCKED)Frequency: 2789 Hz ±5 %Duration: Long sound, short pause,long sound, short pause,long soundBASE STATE STOP (KEYS LOCKED)Frequency: 2763 Hz ±5 %Duration: Long sound, short pause,long sound, short pause,long sound++CARTRIDGE CONTENT

ESoundFunctionSoundFunction++50 U < CARTRIDGE CONTENT

SoundFunctionSoundFunctionReminder (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %,f2 = 1850 Hz ±5 %Duration: f1 medium sound, shortpause, f2 medium sound,short pause, f1 mediumsound, medium pause,f2 medium soundRepeatingInterval: 3000.0 ms ±20 %WARNING (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %,f2 = 1850 Hz ±5 %Duration: f1 medium sound, shortpause, f2 medium sound,short pause, f1 mediumsound, medium pause,f2 medium sound, shortpause, f2 medium soundRepeatingInterval: 3000.0 ms ±20 %ERROR (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %,f2 = 1850 Hz ±5 %Duration: f1 medium sound, shortpause, f2 medium sound,short pause, f1 mediumsound, medium pause,f2 medium sound, shortpause, f2 medium sound,short pause, f2 medium soundRepeatingInterval: 3000.0 ms ±20 %UPPER LIMIT REACHEDFrequency: 2486 Hz ±5 %, 3131 Hz ±5 %,2486 Hz ±5 %, 3131 Hz ±5 %Duration: 4 × short soundLOWER LIMIT REACHEDFrequency: 2090 Hz ±5 %, 2486 Hz ±5 %,2090 Hz ±5 %, 2486 Hz ±5 %Duration: 4 × short sound198

ESoundFunctionSoundFunction++++OK KEY PRESSEDFrequency: 2789 Hz ±5 %Duration: Short soundCHANGED TO BASE STATE RUN BY CHECKKEY (KEYS UNLOCKED)Sequence: A12, long pause, A14CHANGED TO BASE STATE RUN BY CHECKKEY (KEYS LOCKED)Sequence: A12, long pause, A15CHANGED TO BASE STATE STOP BY CHECKKEY (KEYS UNLOCKED)Sequence: A12, long pause, A16CHANGED TO BASE STATE STOP BY CHECKKEY (KEYS LOCKED)Sequence: A12, long pause, A17INITIAL POINT (SUBMENU, VALUE)Frequency: 2820 Hz ±5 %Duration: Short sound, short pause,short soundSUPERVISOR SEQUENCE (GENERATED BYSUPERVISOR)Frequency: 2630 Hz ±10 %, 95 ms ±10 %Pause: 95 ms ±10 %Frequency: 2630 Hz ±10 %, 95 ms ±10 %Pause: 95 ms ±10 %Frequency: 2630 Hz ±10 %, 95 ms ±10 %Pause: 200 ms ±10 %Frequency: 2630 Hz ±10 %, 95 ms ±10 %Pause: 95 ms ±10 %Frequency: 2630 Hz ±10 %, 95 ms ±10 %+CHANGED TO BASE STATE STOP BYCANCELLATION OF FUNCTIONSequence: A13, long pause, A16199

Tactile SignalsDedicated functions of the Accu-Chek Spirit Combo insulin pumpare supported by tactile signals additionally. The tactile signalsare vibrations which are generated by a vibra motor.SignalFunctionSignalFunctionSHORT VIBRATIONDuration short vibration =109.375 ms ±5 %MEDIUM VIBRATIONDuration medium vibration =203.125 ms ±5 %LONG VIBRATIONDuration long vibration = 281.25 ms ±5 %WARNING AND Reminder(REPEATING SEQUENCE)Duration vibration = 1062.5 ms ±5 %Duration pause = 2125.0 ms ±5 %(Repeating interval = 3187.5 ms ±5 %)ERROR (REPEATING SEQUENCE)Duration vibration = 531.25 ms ±5 %Duration pause = 1062.5 ms ±5 %(Repeating interval = 1593.75 ms ±5 %)200

Appendix F: SymbolsFDisplay SymbolsIconMeaningIconMeaningBasal Lock OFFBluetooth ® ONBasal Lock ONBluetooth ® SettingsBasal RateBluetooth ® in Remote controlmodeBasal Rate TotalBeep TestBattery EmptyCartridge EmptyBattery LowCartridge FullBeep VolumeCartridge LowBluetooth ® OFFOK201

IconMeaningIconMeaningClockKey Lock ONData Transfer menuPump timer (Call for update)Data Transfer (to start screen)Menu SettingsData Transfer runningMultiwave BolusDateMultiwave Bolus ImmediateDate Format EUMy DataDate Format USPairing FailedDisplay contrastPairing SuccessfulExtended BolusPrimingKey Lock OFFProgress Bar202

FIconMeaningIconMeaningPump SettingsStopReminderTotalReminder EverydayTemporary Basal RateReminder OFFTherapy SettingsReminder SettingsTime and Date SettingsReminder SingleUnitsScreen OrientationUnits per hourBeepVibrationsBeep and VibrationErrorStandard BolusWarning203

General SymbolsIconMeaningIconMeaningCaution. Please refer to safetyrelatednotes in the manualaccompanying this device.Expiry dateConsult instructions for useCatalogue numberSterilized using ethylene oxideSerial numberSterilized using radiationAdmissible temperature rangeduring operationSterilized using antisepticsStore atYear of manufactureAdmissible humidity rangeLot numberAdmissible air pressure range204

FIconMeaningIconMeaningFragile – handle with careDo not use if the package isdamagedProtect against moistureFlammableProtect from heat and sunlightBluetooth ® wireless technologyFor single use onlyDoes not contain pyrogenDoes not contain PVCRecyclingIPX8Electronic device of type BFaccording the standardIEC 60601-1. Protection againstelectrical shock.Symbol for protection against theeffect of temporary immersion ofwater (up to 60 minutes and2.5 meters [8 feet]), according toIEC 60529.Do not throw away205

IconMeaningIconMeaningFCC IDMarking of conformity according tothe European Medical DeviceDirective MDD 93 / 42 / EEC with thenumber of the notified body.Includes also RTTE DIRECTIVE1999 / 5 / EC.The FCC ID (Federal CommunicationsCommission Identification)indicates that the radio frequencyequipment has passed theequipment authorization processfor the United States of America.N20091The compliance mark indicatesthat the product complies with theapplicable standard and establishesa traceable link between theequipment and the manufacturer,importer or their agent responsiblefor compliance and for placing iton the Australian and New Zealandmarket.Federal law (USA) restricts thisdevice to sale by or on the orderof a physician.IC IDThe IC ID (Industry CanadaIdentification) indicates that theradio frequency equipment haspassed the equipment authorizationprocess for Canada.ManufacturerNon-ionizing radiationRecommended battery206

Appendix G: WarrantyGAny changes or modification to the devices not expresslyapproved by Roche Diagnostics could void your operatingwarranty for the Accu-Chek Spirit Combo insulin pump.Please refer to the warranty provisions in your written terms ofsale for the Accu-Chek Spirit Combo insulin pump and/or theapplicable warranty regulations in your jurisdiction.207

GlossaryAccu-Chek Aviva Combo or Performa ComboThis is an intelligent diabetes management device that enablesyou to measure your blood glucose level, manage your bloodglucose data, and get bolus advice. It also enables remotecontrol of your Accu-Chek Spirit Combo insulin pump, usingBluetooth ® wireless technology.AdapterThe adapter connects the cartridge and infusion set. It has 2seals and forms an efficient seal for the cartridge compartmentof your Accu-Chek Spirit Combo insulin pump. The 2 small ventson the adapter allow the equalization air pressure.Automatic OffAutomatic Off is a safety feature that stops insulin delivery andtriggers an Error if no keys are pressed within a programmedtime period in RUN mode. See the entry in chapter 5 Personalizingyour pump.Basal rateThis is the amount of insulin delivered per hour that is requiredto cover your basic insulin needs. In insulin pump therapy, yourbasal rate is determined together with your doctor or healthcareteam and can be adjusted to meet your individual physiologicalneeds throughout the day. Your basal rate is delivered by yourAccu-Chek Spirit Combo insulin pump according to the curve ofyour personal basal rate profile or profiles.Basal rate profileYour Accu-Chek Spirit Combo insulin pump offers you the optionof delivering up to 5 different basal rate profiles in order to easilymeet your changing insulin needs (for example during the weekrather than at the weekend). A basal rate profile consists of24 programmed hourly basal rates.Basal rate totalThe sum of all 24 hourly basal rates in one basal rate profile iscalled the (daily) basal rate total.208

Bluetooth ® wireless technologyThe term “Bluetooth” refers to a wireless technology that allowsdigital devices to transfer data at high speed. This technology iscommon in many portable devices such as portable PCs, PersonalDigital Assistants and mobile telephones.BolusThe amount of insulin delivered (in addition to the basal rate) tocover the intake of food and to correct high blood glucose levels.The bolus amount is determined by your doctor or healthcareteam’s guidelines, your blood glucose level, your food intake andyour activity level.Carrying systemA wide variety of carrying systems made of different materialsare specially designed to suit your individual needs while wearingyour Accu-Chek Spirit Combo insulin pump.CartridgeThe insulin reservoir of your Accu-Chek Spirit Combo insulinpump. It holds 3.15 ml (315 U) of short acting insulin or fastacting insulin analogue.Cartridge compartmentThe chamber in your Accu-Chek Spirit Combo insulin pump forthe cartridge.Daily insulin totalThe total amount of insulin delivered (basal rate plus boluses)delivered in a 24-hour day, beginning at midnight. This amountdoes not include any insulin needed for the priming of infusionsets.Factory settingsYour Accu-Chek Spirit Combo insulin pump is provided by RocheDiagnostics with a standard configuration (factory settings).These settings can be adapted to your individual needs directlyon your Accu-Chek Spirit Combo insulin pump or by using theAccu-Chek Insulin Pump Configuration Software.Hourly basal rateAn hourly basal rate is the amount of insulin delivered by yourAccu-Chek Spirit Combo insulin pump in 3-minute intervals foreach hour.209

Infusion setInfusion sets connect your Accu-Chek Spirit Combo insulin pumpto your body. The insulin is delivered from the cartridge through theinfusion set tubing and cannula or needle into your subcutaneoustissue. Infusion sets can be disconnectable or non-disconnectable.Infusion siteThe place where the infusion set cannula or needle is insertedinto your subcutaneous tissue to deliver insulin.InsulinA hormone that helps cells transform glucose into energy. Insulinis produced in the beta cells of the pancreas (also called islets ofLangerhans).Insulin analogue (rapid-acting)A type of insulin created using recombinant DNA technology.The onset time of insulin analogue is shorter than the onset timeof regular insulin.IPX8 according to IEC 60529Protection against the effects of temporary immersion in water.Ingress of water in quantities causing damage is not possiblewhen the device is temporarily immersed in water understandardized conditions (maximal 60 minutes a day and2.5 meters [8 feet]).Luer-lock connectorA standardized fitting at the end of the infusion set which allowsto tightly connect the infusion set and cartridge through theadapter.MeterSee Accu-Chek Aviva Combo or Performa Combo.OcclusionAn occlusion is a blockage which prevents the insulin fromflowing correctly from the insulin pump into the body.Insulin, regular (short-acting or fast-acting)Insulin that has the same chemical structure as insulin producedby the human pancreas. The onset time of regular insulin is 30 to45 minutes.210

Personal settingsYour Accu-Chek Spirit Combo insulin pump must be programmedwith your personal settings prior to starting insulin pump therapy.Personal settings include the basal rate profile(s), the correcttime and date and all other variable values which can be tailoredto your individual needs on your Accu-Chek Spirit Combo insulinpump or using Accu-Chek Insulin Pump Configuration Software.Rapid-acting Insulin analogueSee Insulin analogue (rapid acting).Regular insulin (short-acting or fast-acting)See Insulin, regular (short-acting or fast-acting).RUNDuring normal use, your Accu-Chek Spirit Combo insulin pumpis in RUN mode and insulin is continuously delivered. Boluses,Temporary Basal Rates and almost all functions can be programmedfrom RUN mode.RUN screenThe RUN screen is the starting point for all functions which canbe accessed while your Accu-Chek Spirit Combo insulin pumpdelivers insulin. Your Accu-Chek Spirit Combo insulin pumpdisplays the RUN screen during normal use when no programmingis being performed. The time, current hourly basal rate, selectedbasal rate profile and all currently activated functions appear onthe RUN screen.SettingsSettings are individually programmable values and parametersthat affect the way your Accu-Chek Spirit Combo insulin pumpworks.ScrollingScrolling allows a fast and easy programming of a range ofvalues.STOPWhen your Accu-Chek Spirit Combo insulin pump is in STOP, itdoes not deliver any insulin. The insulin delivery is only stoppedif an Error occurs or if your Accu-Chek Spirit Combo insulin pumpis put into a necessary STOP, (e.g. when changing the cartridge,adapter or infusion set or for data transfer). Functions such asExtended Bolus or Temporary Basal Rate are interrupted byputting your Accu-Chek Spirit Combo insulin pump into STOP.211

STOP screenThe STOP screen is the starting point for all functions thatrequire that your Accu-Chek Spirit Combo insulin pump doesnot deliver insulin.Temporary Basal RateTemporary increase or decrease of your basal rate profile inpercentages (from 0 – 500 %) to match changing insulin needsdue to increased or decreased activity level, illness or stress.U100This is the insulin concentration. Each millilitre of liquid contains100 International Units of insulin. Your insulin pump has beendeveloped exclusively for delivery of U100 short-acting insulin orrapid-acting insulin analogue.212

IndexAAbbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 19Accu-Chek Aviva Combo .......................... 7, 133Accu-Chek Performa Combo ....................... 7, 133Adapter ................................ 1, 20, 150, 193ADVANCED user menu . . . . . . . . . . . . . . . . . . . . . . . . . 100, 120Air bubbles ....................... 20, 42, 46, 49, 50, 173Aircraft .................................. 63, 135, 141Alarm data menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 116, 172Automatic Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129, 160BBasal rate profile . . . . . . . . . . . . . . . . . . . . . 121, 131, 189, 194Battery ................. 1, 20, 26, 154, 176, 191, 193, 201Battery cover . . . . . . . . . . . . . . . . . . . . . . . . . 1, 21, 26, 66, 193Battery key ..................................... 1, 26Beeps and melodies ............................... 195Beep volume ....................... 15, 57, 115, 151, 172Blood glucose levels ....................... 22, 25, 41, 77Bluetooth ® connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171Bluetooth ® function . . . . . . . . . . . . . . . . . . . . . . . . 63, 135, 136Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Bolus history .................... 81, 83, 92, 106, 157, 176Bolus increment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Buttons .......................................... 17CCartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42, 44, 73Cleaning your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Configuration parameters ........................... 189Contact with water . . . . . . . . . . . . . . . . . . . . . . . . . 67, 146, 147CUSTOM user menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 130, 131DDamage to your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 45, 47Display contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Display orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Display screensFunction screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Information screens ........................... 16, 17navigating through ............................... 10QUICK INFO screen ........................... 12, 106RUN screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11STOP screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Disposing of your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150213

214EElectromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . 183Electromagnetic radiation ............................ 62Emergency kit ................................. 22, 144Errors .......................................... 159Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35, 62, 121Extended Bolus ......... 77, 84, 85, 87, 88, 98, 177, 190, 202FFeatures .................................... 7, 8, 100HHistory of daily insulin totals ........... 25, 49, 108, 127, 176Hourly basal rate. . . . . . . . . . 11, 17, 37, 38, 172, 177, 189, 209IInfection ..................... 19, 52, 54, 57, 72, 144, 150Infusion set ..................... 12, 48, 49, 50, 52, 56, 69Inspecting your pump .............................. 143Insulin deliverystarting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55, 104stopping ................................... 56, 104KKeylock ............................ 9, 18, 113, 114, 191Keyscombining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17LLanguageselecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101, 119Leakage ................................ 42, 43, 59, 69Luer-lock connector . . . . . . . . . . . . . 43, 47, 69, 70, 71, 74, 179MMaintaining your pump ............................. 149Meterinteraction with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7pairing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136Multiwave Bolus ....... 77, 89, 90, 92, 98, 121, 177, 190, 202PPersonalizing your pump ........................... 8, 99Personal settings . . . . . . . . . . . . . . 23, 35, 53, 58, 98, 121, 149Prime amount .................................... 127Priming ....................... 49, 50, 127, 134, 174, 202Pump data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Pump settings .................................... 113Pump therapyinterruption of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64QQuick Bolus . . . . . . . . . 8, 16, 78, 79, 80, 81, 85, 126, 177, 190

RReminderslist of ................................... 170, 220Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124, 203Repair of your pump ............................... 148Rotating display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 10SSafety system .................................... 151Scrolling ...................................... 18, 82Sport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Standard Bolus ... 77, 78, 80, 81, 82, 83, 85, 89, 177, 190, 203Start-up process ................................... 29Status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Status of your pump .............................. 9, 14Sterile disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Sterile products . . . . . . . . . . . . . . . . . . 19, 57, 69, 76, 143, 145STOP-Warningconfirming ............................... 15, 36, 57turning off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57Storing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Swimming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67, 146SymbolsDisplay Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201General Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201TTactile signals .................................... 200Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61, 175Temporary Basal Rate ............ 93, 94, 95, 96, 97, 98, 156,. . . . . . . . . . . . . . . . . . . . . . . . . . . .157, 177, 189, 194, 203, 219Temporary Basal Rate historyviewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Therapy settings .................................. 126Time and DateSettings .................................... 32, 33Time remaining (pump timer) . . . . . . . . . . . . . . . . . . . . . . . . 110Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 111Travelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Troubleshootingtherapy-related issues ........................... 172UUnlocking Keylock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114WWarning historyviewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Warningslist of .......................................153215

216Warnings and Errors ............................... 151confirming .................................... 152handling ...................................... 140Warranty ..................................... 21, 207Wearing your pumpcarrying systems . . . . . . . . . . . . . . . . . . . . . . . . . 61, 62, 193in hazardous areas ............................... 62

217

Quick reference table for Errors, Warnings and RemindersErrorsNo Error What you have to doE1 CARTRIDGE EMPTY Change the cartridge.E2 BATTERY EMPTY Change the battery.E3 AUTOMATIC OFF Put your Accu-Chek SpiritCombo insulin pump into RUN ifnecessary.E4 OCCLUSION Change the cartridge andinfusion set. See section 2.6 to2.9.E5 END OF OPERATION Arrange for immediate replacementof your Accu-ChekSpirit Combo insulin pump.Contact your healthcareprofessional for alternativeinsulin therapy options.No Error What you have to doE6 MECHANICAL ERROR See chapter 8.E7 ELECTRONIC ERROR See chapter 8.E8 POWER INTERRUPT See chapter 8.E9 END OF OPERATION Arrange for immediate replacementof your Accu-ChekSpirit Combo insulin pump.Contact your healthcareprofessional for alternativeinsulin therapy options.E10 CARTRIDGE ERROR See chapter 8.E11 SET NOT PRIMED Prime your infusion set.E12 DATA INTERRUPTED Restart the data transfer.E13 LANGUAGE ERROR See chapter 8.218

WarningsNo Warning What you have to doW1 CARTRIDGE LOW Change cartridge before it iscompletely empty.W2 BATTERY LOW Replace the battery as soon aspossible.W3 REVIEW TIME Set the time and date.W4 CALL FOR UPDATE Contact your local pumpsupport.W5 PUMP TIMER In the MY DATA menu check forthe remaining operation timeunder the menu PUMP TIMER.Arrange for re-placement ofpump within the scheduledpump operation time.No Warning What you have to doW6 TBR CANCELLED Put your Accu-Chek SpiritCombo insulin pump into RUN ifnecessary. Ensure the cancellationwas intended and programa new Temporary Basal Rate ifnecessary.W7 TBR OVER Decide whether a furtherTemporary Basal Rate change isappropriate and program one ifnecessary.W8 BOLUS CANCELLED Put your Accu-Chek SpiritCombo insulin pump into RUNif necessary. Ensure that thecancellation was intended andprogram a new bolus ifnecessary.219

ReminderNo Warning What you have to doW9 LOANTIME WARNING In the MY DATA menu, check forthe remaining insulin pump loantime under the menu PUMPTIMER. Arrange for replacementof pump within the scheduledpump loan time.W10 BLUETOOTH FAULT Re-do pairing procedure forinsulin pump and Meter. Seesection 6.4 Troubleshooting theBluetooth ® connection in theUser Guide for detailedinformation.No Reminder What you have to doReminderEND OF WARRANTYPut your Accu-Chek SpiritCombo insulin pump into RUN ifnecessary.Contact your local pumpsupport.Some Reminders and Warnings are country specific and maynever occur on your pump.220

My notes221

Bluetooth ® registrationPlease note that in Italy and France Bluetooth ® wirelesstechnology is for indoor use only.FCC ID RAH3IC ID 7937A-3This Class B digital apparatus complies with Canadian ICES-003.Cet appareil numérique de la classe B est conforme à la normeNMB-003 du Canada.This device complies with part 15 of the FCC Rules. Operationis subject to the following 2 conditions: (1) This device may notcause harmful interference, and (2) this device must accept anyinterference received, including interference that may causeundesired operation.Note: This equipment has been tested and found to comply withthe limits for a Class B digital device, pursuant to part 15 of theFCC Rules. These limits are designed to provide reasonableprotection against harmful interference in a residential installation.This equipment generates, uses and can radiate radiofrequency energy and, if not installed and used in accordancewith the instructions, may cause harmful interference to radiocommunications. However, there is no guarantee that interferencewill not occur in a particular installation. If this equipmentdoes cause harmful interference to radio or television reception,which can be determined by turning the equipment off and on,the user is encouraged to try to correct the interference by oneor more of the following measures: Reorient or relocate thereceiving antenna. Increase the separation between the equipmentand receiver. Connect the equipment into an outlet on acircuit different from that to which the receiver is connected.Consult the dealer or an experienced radio / TV technician forhelp. Changes or modifications not expressly approved by theparty responsible for compliance could void the user’s authorityto operate the equipment.222

The compliance mark indicates that the product complies withthe applicable standard and establishes a traceable link betweenthe equipment and the manufacturer, importer or their agentresponsible for compliance and for placing it on the Australianand New Zealand market.N20091223