Disetronic Medical Systems 3 Bluetooth Transceiver Insulin Pump User Manual USer Manual

Disetronic Medical Systems AG Bluetooth Transceiver Insulin Pump USer Manual

USer Manual

Disetronic Medical Systems AGLabeling ServicesPrüflabelDatum:Ersteller:Mat-Nr./R:Labeling Bezeichnung:bezieht sich auf Spezifikation: Accu-Chek Spirit ComboManual usChristoph Mathys05504929001/B26.08.200901n/a
INSULIN PUMP f OK keyd Menu keya Up keys Down keyYour insulin pumpAdapter Luer lock of infusion setCartridge compartment with cartridgeUser Guide05504929001/B Status: 08-2009 Master: 05184843001/DThe Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by ACCU-CHEK is under license. Other trademarks and trade names are those of their respective owners.ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK AVIVA COMBO, ACCU-CHEK ULTRAFLEX and DISETRONIC are trademarks of Roche.USA:Manufactured for and distributed by:Disetronic Medical Systems Inc.Fishers, IN 46037, USAToll free 1-800-280-7801Disetronic Medical Systems AG3401 Burgdorf, Switzerlandwww.accu-chek.com Swiss made
Your contact for assistance with and /or additional information about your Accu-Chek Spirit Combo insulin pump:Distributed in USA by:Disetronic Medical Systems Inc.11800 Exit 5 Parkway, Suite 120Fishers, IN 46037, USAToll Free 1-800-280-7801info@disetronic-usa.comwww.disetronic-usa.comFor technical support please contact Accu-Chek Pump Support at 1-800-688-4578Press j d to move forwardPress jd + a simultaneously to move backwardPress jf to select or savePress ja to go upPress js to go downBRP = Basal Rate Prole 2–4Overview of ADVANCED user menuffRUN STOPffBRP 4BRP 3BRP 2BRP 4BRP 3BRP 2RUN STOP Accessible menus in CUSTOM user menu can be selected using Accu-Chek PC software (sold separately).Press j d to move forwardPress jd + a simultaneously to move backwardPress jf to select or savePress ja for upPress js for down = not accessible in STANDARD user menuOverview of STANDARD and CUSTOM user menus
Pump details and accessoriesCartridge plungerEnd platePiston rodAdapterBatteryBattery coverBattery keyCartridgeInfrared window(next to Battery cover)Cartridge Compartment
Dear Accu-Chek Spirit Combo insulin pump user,This User Guide is provided for you, as a person with diabetes, and for healthcare professionals. It contains all the necessary information for safe and efcient use of your Accu-Chek Spirit Combo insulin pump. Regardless of your level of experience with pump therapy, please read this document carefully before beginning insulin pump therapy. Always refer to this document rst, when you have questions about or have problems using your insulin pump. If you cannot nd the solution to your problem in this document, then we recommend that you contact your local pump support. You will nd the address and phone number on the inside back cover of this manual.Intended Use of the Accu-Chek Spirit Combo insulin pumpThe Accu-Chek Spirit Combo insulin pump is intended for the subcutaneous continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.The Accu-Chek Spirit Combo insulin pump is intended for the use of U 100 rapid-acting insulin.Do not use your insulin pump for the delivery of medication other than U100 rapid-acting insulin.Your Accu-Chek Spirit Combo insulin pump is a valuable medical device. We strongly encourage you to add your insulin pump to your home contents insurance policy to protect you in case of accidental damage or loss. Ask your insurance agent for details.
About this User GuideTo ensure safe and convenient use of your new Accu-Chek Spirit Combo insulin pump, some information in this User Guide requires particular attention. This information is presented as “Warning”, “Caution” or “Note”. A “Warning” informs you about risks to your health. Neglecting jthis information may even lead to life-threatening situations in some cases. A “Caution” informs you about risks to your device. Malfunction jor damage may result if you do not follow these instructions.A “Note” contains important information relating the efcient jand smooth operation of your new Accu-Chek Spirit Combo insulin pump.
5 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 prole 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 proles 1215.9 Setting a Reminder 1245.10 Therapy settings 1265.11 CUSTOM user menu 130
66 Using the Accu-Chek Spirit Combo insulin pump 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 1508 Warnings and Errors 1518.1 Conrming a Warning or Error 1528.2 List of Warnings 1538.3 List of Errors 1598.4 List of Reminders 1709 Troubleshooting 1719.1 Therapy-related issues 172Appendix A: Technical Data 175Appendix B: Conguration parameters 189Appendix C: Sterile products and accessories 192Appendix D: Abbreviations 194Appendix E: Beeps and melodies 195Appendix F: Symbols 201Appendix G: Warranty 206Glossary 209Index 215Quick reference table for Errors, Warnings and Reminders 219My notes 222Bluetooth ® registration 223
711.1 OverviewYour Accu-Chek Spirit Combo insulin pump has many helpful features that help to ensure safe and efcient pump therapy.Note In this User Guide the term “Meter” always refers to the Accu-Chek Aviva Combo Blood Glucose Meter.1.1.1 Summary of featuresInteraction with the MeterThe Accu-Chek Spirit Combo insulin pump is designed for use with the Meter. This new product is an intelligent blood glucose meter that can remote control the pump using Bluetooth ® wireless technology.Three user menusYour Accu-Chek Spirit Combo insulin pump has been designed to adapt to your level of experience in pump therapy – whether you are a beginner or an experienced pump user. Your pump “grows” with you!You can use one of three menus – STANDARD, ADVANCED or CUSTOM – to access the functions and settings you will need from day to day. 1 Understanding your new system
8STANDARD This is the most basic menu – designed for simplicity and comfort.ADVANCED This menu helps you to adjust your therapy to a wider range of situations.CUSTOM The CUSTOM menu enables you to ne-tune your pump according to your personal needs and skill level.See chapter 5 Personalizing your pump.Five basal rate prolesYou can choose from ve basal rate proles, in line with your different daily routines.Four bolus typesYour Accu-Chek Spirit Combo insulin pump enables you to program four bolus types, each corresponding to different situations you may encounter, and this provides you with a lot of exibility.Quick BolusYou can program a Quick Bolus without looking at the display screen and check that it is correctly programmed by counting the beeps and vibrations. This is particularly useful when you want to program the bolus discreetly in public.Dual signalling of Warnings and ErrorsFor your safety, Warnings and Errors are signalled using both audible beeps and vibration of the pump. In addition, the beep tones are fully adjustable – from silent to loud.Data transferThe infrared port on the bottom of your Accu-Chek Spirit Combo insulin pump enables you to transfer information between your pump and a personal computer or handheld device. Rotating displayYour pump’s display can be rotated 180 degrees, and you can also adjust its contrast. Combined with the backlight, these features make the display easier to read.
91ReminderAs 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 by either disposable or rechargeable batteries. (If you decide to use rechargeable batteries, you will need a battery charger recom-mended by the battery manufacturer.)KeylockThe Keylock feature allows you to lock all four keys on your pump to prevent the accidental activation of functions. For example, you can use Keylock while you are asleep or when playing sports. 1.2 Display and soundsYour Accu-Chek Spirit Combo insulin pump has a Liquid Crystal Display (LCD) screen. This display, together with the four keys, enables you to program the pump. It also shows important information about the status of your pump. w WARNING Changes in the status of your pump can be life-threatening. If for any reason you cannot hear the audible signals or feel the vibrations of your pump, looking at the display is the only way that you will be aware of changes or malfunctions in your pump.
101.2.1 BacklightThe backlight helps you to read the information on the display in poorly-lit areas. You can turn on the backlight while in RUN or STOP mode, or when navigating through the menus, by pressing a.The backlight turns on automatically when a Reminder, Warning or Error message is displayed, and turns off automatically after 10 seconds if no further keys are pressed.Tip: In poorly-lit areas, begin programming with the a.1.2.2 Rotating displayYour pump’s display can be rotated 180 degrees. See section 5.6.4 Display orientation.Note that when you rotate the display, the s and a key functions are reversed.c CAUTION If incomplete characters, numbers or symbols appear on the display, put your pump into STOP mode and remove the battery for a few seconds. When you reinsert the battery, the pump will perform a system check. If this does not resolve the problem, put your pump into STOP mode and contact your local pump support. For details see inside the back cover.
1111.2.3 Display screensThe screens displayed by your pump relate to one of the following modes:RUN, STOP and Quick Info jInformation jFunction jSet-up jThe Information, Function and Set-up screens are all accessed from the user menus. See section 5.2 Selecting a user menu.Note To save battery life, the screen of your Accu-Chek Spirit Combo insulin pump goes blank when you do not press any key for more than 20 seconds. As long as your pump is showing a blank screen, you have to press any key before any other operation can be performed.RUN screenBy default the screen is blank, to save energy, and becomes blank again after 20 seconds without key pressing. By pressing any key, the RUN screen is displayed when the pump is in RUN mode. This means that insulin is being delivered to your body according to the basal rate you have programmed. Keylock lockedpump timercartridge lowbattery lowactive basal rate proletimecurrent hourly basal rateThe above screen shows all the possible symbols, including the current time, the current basal rate prole, and the current hourly basal rate in units per hour.
12The RUN screen also displays Reminder information (such as “cartridge low”) and special functions (such as Keylock – locked or unlocked) in the form of symbols. (See Appendix F: Symbols)Note After you program or review information, the pump returns 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 STOP symbol.Keylock unlockedpump timercartridge lowbattery lowtime dateThe STOP screen also displays Reminder information (such as “battery low”) and special functions (such as Keylock – locked or unlocked) in the form of symbols.Your pump must be in STOP mode in the following situations:You areprogramming specic functions jchanging the cartridge and / or the infusion set j jpriming the infusion set jtransferring data to or from the pumpchanging the battery jQuick Info menuYou display the QUICK INFO screen by pressing the f key while in RUN or STOP mode. The QUICK INFO screen shows the remaining insulin content of the cartridge in units.
131By pressing f again you enter the BOLUS DATA function. You can view the last 30 boluses by pressing a or s.You can leave the Quick Info screen either by pressing f again or pressing no key for 20 seconds.Information, Function and Set-up screensYou access these screens when you program the pump, perform a function, change a setting, or store or transfer information. You can reach these screens from either the RUN or STOP screen.1.2.4 Navigating through the screensThe following procedure explains how to navigate through the screens. Think of these screens as menu choices. See section 1.2.3 Display screens.Press the 1. d key to select a screen of your choice.Press the 2. d key again to see the next available choice in the menu. (After you reach the last menu choice, you will return to the rst menu choice.)When you reach the screen of your choice, press the 3. f button. The next set of screens are called Function screens, and all relate to the choice you have just made. There may be one or several Function screens.Press the 4. s or a key to increase or decrease the displayed value, or press the d key again to move to the next Function screen to make further changes. (After you reach the last Function screen, you will return to the rst Function screen.)Press the 5. f button to save your changes.
14Note You can move backwards through the menu structure – or return to menus you have skipped – by pressing the d key and a key simultaneously. However, if you are in a Function screen, pressing these buttons simultane-ously moves you up one level without saving the current changes.1.2.5 Status messages and alarm signalsYour Accu-Chek Spirit Combo insulin pump informs you of the status of your pump using audible beeps, vibrations and displayed messages. It is vital that you be able to hear and / or feel the beeps and vibrations. Be aware that some carrying pouches may hinder the perception of the signals.You can turn off either beeps or vibrations, but for your safety you cannot turn off both at the same time for the initial alarm signal.See chapter 8 Warnings and Errors for a description of the full range of Warnings and Errors.STOP-WarningThe STOP-Warning is triggered when your pump switches from RUN mode to STOP mode, or when a battery is inserted. The pump beeps twice and vibrates once every minute. This warns you that insulin delivery has been interrupted.
151To turn off the STOP-Warning, press either a or s for three seconds. You then hear a melody, conrming that the STOP-Warning has been turned off. If you press the key too briey, the STOP-Warning will not be turned off.Note For your safety, the volume of the STOP-Warning cannot be changed. It is independent of the programmed beep volume.1.3 Keys and key combinations You use the four keys on the Accu-Chek Spirit Combo insulin pump to program functions, access information, and set up the pump. Each time you press a key the pump will beep, unless the beep tone is set OFF.f OK keyd Menu keya Up keys Down key
16The following table lists the keys and their functions.Key Name Functiond Menu Move through menus, function screens jand information screensf OK Select a menu jSave changes and exit the function and jinformation screensView the Quick Info screen ja Up Move forward in the jinformation screensIncrease a setting jTurn on the backlight jProgram a jQuick BolusCancel a jQuick BolusTurn off the STOP-Warning (press and jhold 3 sec. until you hear a melody)Key Name Functions Down Move backward in the jinformation screensDecrease a setting jProgram a jQuick BolusCancel a jQuick BolusTurn off the STOP-Warning (press and jhold 3 sec. until you hear a melody)c CAUTION Do not press the keys with a sharp or pointed item such as the tip of your ngernail, as this could damage the casing of your Accu-Chek Spirit Combo insulin pump. Instead, use the pad of your ngertip to avoid puncturing the keys.
1711.3.1 Combining keysYou can obtain additional functions by pressing two keys simultaneously. In the following table, a plus symbol (+) indicates that both buttons must be pressed at the same time.Combination Functiond + aExits menus, function jscreens and information screens without saving your changes. Moves you to a previous jmenu.d + sUnlocks the keys. Press and jhold both buttons until you hear three short beeps (RUN mode) or three long beeps (STOP mode).a + sCopies an jhourly basal rate to the following hour.w WARNING If the keys on your pump are not functioning properly, disconnect your pump and contact your local pump support (see inside back cover).
181.3.2 Scrolling To enter larger or smaller values, the a and s keys must sometimes be pressed several times until the desired value is shown, with each press of the key changing the gure by a small increment. However, you can also press and hold the key (scrolling function) to change the value faster. When program-ming boluses and hourly basal rates the increment of the value change 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 four keys on your Accu-Chek Spirit Combo insulin pump. This is a valuable safety measure that prevents you from accidentally activating your pump. For example, you can use Keylock while you are asleep or when playing sports.You turn on the Keylock function in the PUMP SETTINGS – See section 5.6 Pump settings.
1911.4 Accessories and disposablesHigh-quality sterile disposables and accessories are a vital part of the Accu-Chek Spirit Combo insulin pump system, and help to ensure safe pump therapy. Always follow the instructions provided by your doctor or healthcare team – as well as the printed instructions included with the product – relating to the use of these items.Note Use your insulin pump, sterile disposables and accesso-ries for the rst time in the presence of your doctor or healthcare team.1.4.1 Sterile disposablesEach sterile disposable, such as cartridge or infusion set, should be used only once, as re-using these products could lead to infection or could damage your pump. Do not use a sterile product if the package has been damaged or opened.w WARNING Your pump has been designed for use with U100 insulin. Only use sterile disposables and accessories that are designed for use with your Accu-Chek Spirit Combo insulin pump. The correct functioning of your pump can only be guaranteed if you use Accu-Chek brand sterile products and genuine Accu-Chek Spirit Combo insulin pump accessories.
201.4.2 AdapterventsgripsealthreadThe adapter connects the cartridge to the infusion set, and also keeps the cartridge compartment watertight with two seals, one inside and one outside the adapter. It holds the cartridge in place and prevents the entry of air bubbles. The two small vents on the adapter allow air pressure to be equalized inside and outside the cartridge compartment. The adapter will not work properly if the vents are blocked or dirty, or if the seals are missing. Note It is essential to change the adapter at least every two months. You must also change the adapter if the seals become worn, are lost, or if the vents are blocked.1.4.3 BatteryYour pump requires one AA 1.5 V battery in order to function. Use AA high-quality alkaline LR6 or lithium FR6 batteries that have a minimum capacity of 2500 mAh. Do not use carbon zinc or nickel cadmium (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 of 2500 mAh. Always use a battery charger recommended by the battery manufacturer. See Appendix A Technical Data p. 176.
211c CAUTION Use of batteries other than those recommended may signi-cantly reduce battery usage time. Such batteries may also leak and corrode the battery contacts in your pump. Therefore, the use of batteries not supplied or recommended by Roche may void the warranty. Before inserting rechargeable batteries make sure that they are not damaged or leaking as damaged or leaking batteries could damage your pump.Note Always remember to remove the battery if your Accu-Chek Spirit Combo insulin pump is not going to be used for a long period, in order to conserve the battery.Battery coverThe battery cover seals the battery compartment, and must be changed at least every two months. You must remove and replace the battery cover using the battery key – do not use knives, screwdrivers or other sharp objects, as these may damage your pump.Battery keyThe battery key tightens and loosens the battery cover. It is also designed to loosen the luer-lock connection between the infusion set and adapter if it cannot be loosened by hand, by using the notch on the side. However, never use the battery key to attach or tighten an infusion set. Using the battery key prevents possible damage to the battery cover.If you lose the battery key, or if it becomes cracked or worn, order a replacement immediately, rather than using makeshift tools.For a list of recommended accessories and disposables, see Appendix C.
221.5 Emergency kitIt is highly recommended to keep accessories and disposables with you in case of an emergency. This enables you to change these items if necessary. Such an emergency kit should contain:An Accu-Chek infusion set jA new AA alkaline or lithium battery jAn Accu-Chek Spirit 3.15 ml Cartridge System jAn insulin pen or syringe for alternative therapy jA vial of insulin jTreatment for low blood jglucose levelsBlood glucose monitoring equipment j(such as an Accu-Chek blood glucose meter)A disinfectant for skin jA battery key jA battery cover jAn adapter jw WARNING Make sure that you have an alternative therapy plan, provided by your healthcare professional. Use this plan whenever you need to interrupt pump therapy.
2311.6 General safety informationw WARNING Always make sure to accurately program your personal settings to avoid inappropriate insulin delivery. This phrase means that either too much or too little insulin is delivered. Too much insulin can lead to severe hypoglycemia. Too little insulin can lead to a life-threatening ketoacidosis.w WARNING Your insulin pump has not been tested with cardiac pacemakers. For information about the safe use of your Accu-Chek Spirit Combo insulin pump with a cardiac pacemaker, contact the pacemaker manufacturer. For reference see Appendix A Tables 201 – 205.c CAUTION If you should drop your pump, immediately inspect it carefully for damage. Do not use your Accu-Chek Spirit Combo insulin pump if cracks or chips are visible – these may allow water, dust, insulin or other foreign substances to enter the pump and lead to malfunction.
24
2522.2 Inserting the batteryYour Accu-Chek Spirit Combo insulin pump turns on as soon as you insert the battery. When you remove the battery, your pump keeps track of the time and date for about one hour. Your insulin pump settings (such as the hourly basal rates, bolus increment and active user menu) and the event memory (bolus and alarm history, history of daily insulin totals and Temporary Basal Rates) are always saved, regardless of battery condition or the amount of time your pump has been without a battery. See section 1.4.3 Battery for information on batteries (both disposable and rechargeable types).This chapter explains how to prepare your pump and begin insulin pump therapy. 2.1 Before you beginSuccessful insulin pump therapy requires you to check your blood glucose levels frequently. It is therefore recommended that you use an Accu-Chek blood glucose meter as often as directed by your doctor or healthcare team.Your Accu-Chek Spirit Combo insulin pump has been designed for use with the Meter. This intelligent blood glucose meter enables communication with your pump using Bluetooth ® wireless technology.2 Getting started
26Insert the battery, negative (–) end rst, positive (+) end up, into the compartment.4.Press d to move to the STOP YOUR PUMP screen.Press f to select. Your pump is now in STOP mode and insulin delivery stops.1.Remove the battery cover.Use the battery key to turn the battery cover counter-clockwise. Make sure that the opening of the battery compartment and the seal are clean and undamaged. Where appropriate, remove the old battery.3.Procedure for inserting and changing the batteryRemove or disconnect your infusion set from the infusion site, to ensure that there is no risk of accidental insulin delivery. 2.
272Place the cover on the positive end and gently push the battery in, while turning the cover clockwise to partially tighten it.5.Use the battery key to fully tighten the battery cover. You can verify that the battery cover is correctly tightened by checking that it is in line with the pump casing. Do not over-tighten.6.After inserting the battery, the pump begins its start-up process (see next section).In case the pump does not begin the start-up process after inserting the battery, make sure that the battery is inserted correctly (negative end rst).
28c CAUTION To prevent water from entering the pump casing, only insert or change the battery in a dry environment. Make sure that the battery cover seal is not worn or missing, and that the battery is correctly inserted.Note If your pump was in RUN mode before you removed the battery, the Error E8: POWER INTERRUPT will occur when the new battery is inserted. Press f twice to conrm and snooze the Error. Check the time and date and correct them if necessary. Then put your pump into RUN mode. See section 2.4 Setting the time and date.
2922.3 Start-up processYour pump runs a start-up process when you insert a battery or when you change the cartridge. During this process, your pump performs a series of internal tests.When you … Then …change the battery the whole start-up process is performed.When you … Then …change only the cartridgethe start-up process begins at the SELF-TEST screen.w WARNING Do not interrupt the start-up process by pressing keys or otherwise handling the insulin pump. Interruption of the process may lead to malfunction of your pump.The software version screen appears. The Accu-Chek logo appears. The SELF-TEST screen appears.1. 2. 3.Start-up process sequence
30The display then shows a pattern. Check that the pattern is even.The BEEP TEST screen appears and your pump beeps.Listen for the beeps.w WARNING If you cannot hear the beeps from your Accu-Chek Spirit Combo insulin pump, you may not be notied of changes within the pump in time to take action. If you do not hear the beeps, stop using the pump and contact your local pump support. (See inside back cover)The VIBRATION TEST screen appears and your pump vibrates.Check the vibrations.w WARNING If you cannot feel the vibrations, you may not be notied of changes within the pump in time to take action. If you do not feel the vibrations, do stop using the pump and contact your local pump support. (See inside back cover)The display then goes blank. Check that the display is empty. (The backlight turns on during this step.)4. 5.6. 7.
312The display turns black. Check that the display is completely black.After the self-test, press a or s to select the type of battery you inserted.Press f to save and exit.If your pump detects a Warning or an Error during the start-up process, it signals the Error or Warning at this point. See section 8.3 List of Errors.The end of the start-up process is signalled by a melody, and the pump displays the STOP screen.The STOP-Warning occurs every minute – the pump emits two short beeps and vibrates to remind you that no insulin is being delivered. To turn the STOP-Warning off, press a or s until you hear a melody and / or feel a vibration.c CAUTION Make sure that you choose the correct battery type. Otherwise you may not be informed about a low battery in time.8. 9. 10.11.
322.4 Setting the time and dateIt is essential to set the time and date correctly, because basal rates and history information are stored on the basis of the time and date set in the pump. When you travel across time zones, and for the change to and from daylight savings time, make sure that the time and date are re-set correctly.You can choose between American or European / Military time.American European / Military12-hour clock 24-hour clockmonth / day / year day / month / yearw WARNING Incorrect setting of the time and date can lead to incorrect basal insulin delivery. Make sure that the time and date of your pump are set correctly, to ensure correct delivery and data memory. Do not make therapy decisions based on a single result in the pump’s memory.w WARNING In addition, if you, your doctor, or healthcare team are reviewing your data electronically, it is essential that you synchronize the time and date of your pump with those of your blood glucose meter, your personal computer or handheld device. Otherwise, the resulting data might not be meaningful. Check these devices regularly to ensure that the settings remain synchronized.
3321. 2. 3.Procedure for setting the time and datePress d to move to the TIME AND DATE SETTINGS 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.
348.7.Press d to move to the TIME FORMAT screen. Press a or s to set the time format.Press d to move to the DATE FORMAT screen.Press a or s to set the date format.Press f to save and exit.
3522.5 Your basal rate proleYour Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings before you begin pump therapy. Your doctor or healthcare team can help you to understand how to use the pump.2.5.1 Programming your basal rate proleYour Accu-Chek Spirit Combo insulin pump delivers insulin every 3 minutes, in 20 equal doses every hour, 24 hours a day. This ow of insulin, measured in international units per hour (U / h), is called the basal rate prole and is calculated to meet your basic insulin needs.The pump can store up to ve different basal rate proles to match your changing insulin needs – for example: Monday to Friday, Exercise Day or Sleeping Late Day.Note For your safety and convenience during programming, your Accu-Chek Spirit Combo insulin pump switches to RUN or STOP screen if no key is pressed within 20 sec-onds. Any changes you have made before this “time-out” occurs will not be saved .An Accu-Chek Spirit Combo insulin pump basal rate prole consists of up to 24 different hourly basal rates. Each hourly rate may be changed independently. The total of all 24 basal rates in one basal rate prole is called the (daily) basal rate total.012345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24TimeExample: Basal rate prole for 18 U / 24 hoursInsulin delivery[U / h] Hourly basal rate
36Your basal rate prole should be reviewed:After any programming changes are made to your pump jAfter a new battery is inserted jAfter jconrming the Error E7: ELECTRONIC ERROR. Note Insulin delivery does not stop or pause during basal rate programming.3.Procedure for programming your basal rate prole1. 2.Press d to move to the BASAL RATE PROGRAMMING 1 (2, 3, 4 or 5 accord-ingly) screen.Press f to select. The daily BASAL RATE TOTAL is displayed.Press d to move to the rst hour.This is always 12 AM – 01 AM.
3724. 5.Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team.Press d to move to the next hour.Continue using d and a or s to set the hourly basal rates for the remaining hours. This allows you to program your individual basal rate prole on an hour-by-hour basis. Continue until all 24 hours are programmed.6. 7.Press f to conrm.The new daily BASAL RATE TOTAL is displayed.Press f to save the prole and exit.Note The increments shown depend on the programmed basal rate: it will be 0.01 U from 0.05 U to 1.00 U, 0.05 U from 1.00 U to 10.0 U and 0.1 U from 10.0 U to 50.0 U
382.Press d to move to the BASAL RATE PROGRAMMING 1 (2, 3, 4 or 5 accord-ingly) screen.Press f to select. The daily BASAL RATE TOTAL is displayed.Copying an hourly basal rateIf your basal rate is the same for multiple hours in a row, you can save time by copying an hourly basal rate to one or more hours.1.3.Press d to move to the hourly basal rate you want to copy.4. 5.Press a and s simultaneously.A special beep conrms that you are pressing the keys correctly. The same hourly basal rate is copied to the next hour.If you want to copy the rate to multiple hours, press a and s repeatedly or press and hold a and s (scroll).
392Press f to conrm.Review the new daily BASAL RATE TOTAL.Press f to save and exit.Note At any point in the programming of your basal rate, you have the following options to exit.If you want to … Then …save the changes Press j f and check the new daily basal rate total.Press j f again. Your pump returns to the RUN screen.undo the changes Wait for your Accu-Chek Spirit Combo insulin pump to return jto the RUN screen, orPress j d and a simultaneously (exit feature) to exit the Function screen.6.
40Selecting a basal rate prolePress d to move to the BASAL RATE SELECTION screen.Press f to select. The SELECT PROFILE for the current basal rate prole is displayed.Press a or s to select a basal rate prole.The SELECT PROFILE screen and its daily basal rate total appear accordingly.Press f to select the displayed prole.The new basal rate prole is active immediately.4.1. 2.3.When you have programmed more than one basal rate prole (ADVANCED or CUSTOM MENU), you can select the required prole. w WARNING Make sure that you select an appropri-ately programmed basal rate prole. Otherwise there could be inappropriate insulin delivery.
412Note When you change your user menu for example from ADVANCED to STANDARD, your current basal rate prole may not appear. If the basal rate prole number(s) you want does not appear:Select the ADVANCED user menu, or jAssign the basal rate prole to an available basal rate jprole number A running Temporary Basal Rate increase or decrease stays active, even if you change the basal rate prole on your pump.Basal rate and bolus During normal use, your pump is in RUN mode and insulin is continuously delivered to your body, according to the basal rate prole you have programmed. A bolus can be programmed as required. A bolus is the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus amount is determined by your doctor or healthcare team’s guidelines and depends on your blood glucose level, your food intake, and your activity level, as well as stress and illness. See section 4.1 Understanding boluses.
422.6 Connecting the cartridge, adapter and 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 ow uncontrolled from the cartridge or infusion set if the cartridge plunger and the piston rod are not properly connected and the pump is positioned at a higher level than the infusion site. Prevent leakage of insulin by correctly inserting the cartridge: move the piston rod to the correct position and twist the adapter until the cartridge plunger is aligned with the end plate of the piston rod. (See section 3.5 Changing the cartridge and infusion set)Have the following materials ready: A lled Accu-Chek Spirit 3.15 ml Cartridge System with a jluer-lock connection (for lling instructions see the instructions for use provided with this product)An Accu-Chek Spirit Combo insulin pump adapter jA new Accu-Chek infusion set jw WARNING Ensure that the cartridge is at room temperature before use to prevent air bubbles.
432Procedure to connect the cartridge, adapter and infusion set2.Carefully prepare a new Accu-Chek infusion set, following the instructions supplied for use.w WARNING To avoid leakage, tightly attach the infusion set to the adapter. Turn the infusion set luer-lock connector until it stops. Do not over-tighten or use any auxiliary tools, as this may crack the infusion set luer-lock connector and result in leakage of insulin.Remove the protective cap from the lled cartridge. (Do not touch the cartridge tip.)3.4.1.Push the adapter all the way onto the cartridge tip, to the stop.Hold the adapter and twist the infusion set luer-lock connection by hand, clockwise into the adapter. Do not over-tighten.
442.7 Inserting the cartridgeHave the following materials ready: A lled Accu-Chek Spirit 3.15 ml Cartridge System with a jconnected Accu-Chek Spirit Combo insulin pump adapter A new Accu-Chek infusion set jProcedure for inserting the cartridgePress d to move to the STOP YOUR PUMP screen.Press f to select. The pump displays the STOP screen, and insulin delivery stops.Disconnect the infusion set.1. 2.w WARNING Do not use your pump for the delivery of medication other than U100 rapid-acting insulin.3.
4528.Make sure your infusion set is discon-nected and the cartridge has been removed.Press and hold f for three seconds, until you hear a melody.The piston rod begins to return. Do not touch or otherwise disturb the piston rod while it is rewinding, as this could result in damage to your pump.7.6.When the piston rod has returned completely, the CARTRIDGE VOLUME screen displays the maximum volume, 315 U.4.Press d to move to the CARTRIDGE CHANGE screen.Press f to select.5.Hold the pump with the adapter facing the ground. Remove the cartridge, if necessary. Unscrew carefully. Do not pull the cartridge out until it is completely unscrewed. c CAUTION Do not change the cartridge if the cartridge compartment is not completely dry. When the piston rod is rewinding, insulin solution could enter your pump and lead to malfunction. If necessary, use a soft cloth to dry the compartment.
46Hold your pump upright. Hold the new lled cartridge so that the connected adapter and infusion set points upwards, parallel, and close to the cartridge compartment.Make sure that the top edge of the threaded part of the adapter is level with the top of the cartridge compartment.10.Press a or s to move the piston rod forward until the end plate of the piston rod is level with the bottom of the cartridge plunger.The CARTRIDGE VOLUME decreases accordingly on the display. 12.11.9.see step 10see step 11
472The cartridge is correctly inserted when the end plate of the piston rod is correctly seated against the cartridge plunger. Check that the infusion set luer-lock connector is still correctly connected to the adapter. Tighten the infusion set clockwise by hand until it sits tightly in the adapter.If the end plate of the piston rod is not correctly aligned with the cartridge plunger, remove the cartridge from the cartridge compartment and repeat steps 9. to 14. 15. 16. 17.Twist (do not push) the adapter clockwise until it is correctly seated against the cartridge compartment.It is not necessary to apply pressure. Do not over-tighten the adapter, other-wise it will be difcult to remove the cartridge, adapter and cartridge plunger, and could cause damage to your pump. 13. 14.Position your insulin pump upright (with the adapter pointing upwards). Insert the cartridge into the cartridge compartment.
4818.Press f after correctly inserting the cartridge.Your pump performs a self-test. See section 2.3 Start-up process.When the self-test process is nished, the INFUSION SET PRIMING screen is displayed.See section 2.8 Priming the infusion set. Start from step 4 in the Pocedure for priming the infusion set.19.
4922.8 Priming the infusion setw WARNING Never prime an infusion set that is connected to your body as you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set you are using.The Accu-Chek Spirit Combo insulin pump stops priming at 25 units of insulin. If no insulin emerges from the needle or there are air bubbles in the tubing after priming, repeat the priming function until the infusion set is bubble-free and completely lled with insulin. When insulin appears at the tip of the needle, press f to stop priming. The amount of insulin used for priming is not added to the pump’s history of daily insulin totals. Your pump should be upright during priming, with the adapter pointing upwards to help let air bubbles out of the cartridge and infusion set.w WARNING Air bubbles in the cartridge and infusion set may result in the infusion of air instead of insulin. If this happens, your body will not receive the required amount of insulin. Remove bubbles while lling the cartridge and priming the infusion set, and without having the infusion set connected to your body.
506.To ensure that any air bubbles are removed always hold your pump upright and, gently tap it with the bottom in the palm of your hand.Make sure your infusion set is discon-nected.Press and hold f for three seconds, until you hear a melody. The priming process begins.5.Procedure for priming the infusion setPress d to move to the STOP YOUR PUMP screen.Press f to select.1. 2. 3.The pump displays the STOP screen, and insulin delivery stops.Prepare the tubing or needle for priming according to the infusion set’s instruc-tions for use.4.Press d to move to the Infusion set PRIMING screen.Press f to select. The priming amount of 25 units of insulin is shown on the display.
5127.The infusion set is properly primed when there are no air bubbles visible in the tubing and a drop of insulin has come out of the needle. When the priming process is complete, your pump returns to STOP.A count-up is shown on the display. Your pump stops priming after 25 units.You can stop the priming process at any time by pressing f.
522.9 Positioning the infusion setAlways follow the instructions given to you by your doctor or healthcare team and the instructions for the infusion set you are using. Change your infusion set as frequently as recommended by the manufacturer. 2.9.1 Preparing the infusion siteInfusion site selection Your doctor or healthcare team will help you choose your infusion site areas according to a planned rotation pattern. Avoid your waistline, bones, scar tissue, recent infusion sites, bruises and sores. Choose an infusion site at least one inch (2.5 cm) away from the navel and previous infusion sites. Infusion site preparation It is important to prepare the infusion site properly to reduce the risks of infection. Your doctor or healthcare team will provide you with infusion site preparation guidelines. Have the following materials ready: Your Accu-Chek Spirit Combo insulin pump jA disinfectant for your skin jA new Accu-Chek infusion set j
5323.Wash your hands thoroughly. Disinfect the infusion site and let it dry completely.Insert the needle of your Accu-Chek infusion set according to the instructions. 2.5.4.2.9.2 Inserting the needleMake sure that your pump is properly connected (including cartridge, adapter and infusion set) and correctly pro-grammed with your personal settings. 1.Make sure your pump is in STOP mode.
54If you have read and followed all instructions, cautions, Warnings and notes found in this chapter, you should now be ready to deliver insulin to your body using your Accu-Chek Spirit Combo insulin pump.Note If you use a soft-cannula type infusion set, you must proceed with a bolus to ll the air space in the needle after removing the introducer needle, according to the instructions for the infusion set you are using. Failure to do so could result in missed insulin dosing. See section 4.2 Programming a Standard Bolus.w WARNING Inspect your infusion site at least twice a day for irritation or infection. Signs of infection may include, but are not limited to: pain, lumps, redness, heat, or discharge. If you see redness or swelling, change your infusion set and infusion site immediately and contact your doctor or healthcare team. Change your infusion headset according to the instructions for the infusion set you are using and your doctor or healthcare team’s recommendations.
5522.10 Starting insulin deliveryProcedure for starting insulin delivery1. 2. 3.When your pump is in STOP mode. Press d to move to the START YOUR PUMP screen.Press f to select. Your pump shows the RUN screen.Insulin delivery begins within 3 minutes.
562.11 Stopping insulin deliveryFor your safety, you should only perform certain functions and actions when the pump is in STOP mode. These functions and actions include:changing the cartridge jconnecting and disconnecting the adapter and / or infusion set j jpriming the infusion set data transfer jc CAUTION When your Accu-Chek Spirit Combo insulin pump is in STOP mode, no insulin is delivered to your body. You must put your pump into RUN mode to continue insulin delivery.Procedure to stop insulin deliveryPress d to move to the STOP YOUR PUMP screen.1. 2.Press f to select. Your pump returns to the STOP screen.Your pump is now in STOP mode. No insulin is being delivered.
572STOP-WarningThe STOP-Warning is triggered when your pump switches from RUN mode to STOP mode, or when a battery is inserted. The pump emits two short beeps and vibrates once every minute. This warns you that insulin delivery has been interrupted.To turn off the STOP-Warning, press either a or s for three seconds. You then hear a melody and / or feel a vibration, conrming that the STOP-Warning has been turned off.If you press the key too briey, the STOP-Warning will not be turned off.Note For your safety, the volume of the STOP-Warning cannot be changed. It is independent of the programmed beep volume.2.12 General safety informationw WARNING The cartridge and infusion set are sterile products intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the packaging is damaged. Do not re-use single-use materials because this might lead to a malfunction of your Accu-Chek Spirit Combo insulin pump, incorrect insulin delivery and / or infection. Always handle these items with clean hands. Avoid any contact of the infusion set and the connecting parts of your insulin pump with antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or any other cosmetics. They may contaminate these parts.
58w WARNING Always check your personal settings before using your new pump, in order to avoid incorrect insulin delivery. Record your personal settings from your current insulin pump, and ensure that they are correctly programmed into your new Accu-Chek Spirit Combo insulin pump. Incorrect programming of your pump 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 inexperi-enced, get your doctor or healthcare team to set or check them. Only change your settings after consulting your doctor or healthcare team.w WARNING The support of a doctor or healthcare team is vital when training on and using your Accu-Chek Spirit Combo insulin pump. Regular visits to your doctor or healthcare team are also essential during insulin pump therapy. Always carefully follow instructions from the medical professionals responsible for your care.Note When an Extended Bolus, a Multiwave Bolus and / or a Temporary Basal Rate (TBR) is / are active and you put your pump into STOP mode, a Warning W6: TBR CAN-CELLED and / or a Warning W8: BOLUS CANCELLED occur(s). Press f twice for each Warning to conrm and turn them off. See section 8.2 List of Warnings.
592Note Your pump cannot detect infusion set leakage. If you detect any loss of insulin and all parts are correctly tightened, immediately replace the leaking component. Because insulin delivery has been interrupted, check your blood glucose level and take appropriate action according to your doctor’s or healthcare team’s instructions.Note If the battery is too low, the start-up process may not be able to complete. In this case, the pump beeps ve tones and keeps restarting the process until you remove the battery or until it is empty.Note Check the amount of insulin remaining in the cartridge at least once a day. If you press f from the RUN or STOP screen, your pump displays the remaining cartridge content in units. Before going to sleep, make sure that:the Pump is in RUN mode jthe cartridge contains enough insulin to last through jthe night the time and date are set correctly j
60
613This chapter provides important guidelines on how to use your pump safely from day to day.3.1 Wearing your pumpAttach your pump safely to your body or clothes to prevent damage. You can use one of our special carrying systems that enable you to carry your pump on or under your clothes. Remember to wear your pump under your clothes or directly on your body in cold or wet weather.c CAUTION When wearing your pump, prevent any contact with objects that could 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 elds and hazardous areasw WARNING Do not use your pump near electromagnetic elds such as radar or antenna installations, high-voltage sources, X-Ray sources, computer tomography, MRI, CAT scan, and all other sources of electrical current, as they may cause your pump to fail. Insulin delivery may stop and an Error E7: ELECTRONIC ERROR may occur.Always stop your pump, remove and leave it outside these areas. See Appendix A: Technical Data for more information about electromagnetic elds.3 Using your pump in daily life
62Your pump has been tested against, and complies with, the regulations on electromagnetic interference. Security systems in airports and anti-theft monitoring devices, such as those in department stores, should not normally affect the functioning of your pump. Because there are so many devices, such as cellular phones, that emit electromagnetic radiation, the effect of such devices on your pump cannot be ruled out. It is therefore recommended to keep your pump at least 4 inches (10 cm) away from these devices while they are active. Do not use your pump in hyperbaric chambers or in hazardous areas, such as areas where ammable gases or vapours could be present. This could cause an explosion.Always stop and remove your pump before you enter these areas. If you have questions, contact your local pump support (see inside back cover).Your pump is designed to work in normal barometric conditions (from 700 to 1060 mbar).3.1.2 Sport and exercise Exercise is an important part of diabetes management. Your Accu-Chek Spirit Combo insulin pump is designed to enable you to safely perform a range of sporting activities while wearing your pump. It is important that you protect your pump before you begin exercise or sporting activities. Do not wear your pump for sports that involve body contact such as boxing, football or hockey, since rough contact could damage your pump. Consult our sterile product brochures and accessories catalogue for more information about carrying systems or contact your local pump support (see the inside back cover) for more information.
633Note Rapid and extreme changes in air pressure, for example in an air plane that is taking off or when practicing sports like hang-gliding, can inuence insulin delivery, especially if there are air bubbles in the cartridge or tubing. This also applies to rapid and extreme changes in temperature; for example, when leaving a heated room and going outside in cold weather. We therefore recommend that you wear your pump close to your body, remove any air bubbles from the cartridge and tubing and also measure your blood sugar more frequently in such situations.3.1.3 Travelling with your pumpAsk your doctor or healthcare team about any special steps you need to take before you travel. Take extra blood glucose testing and pump supplies with you, and nd out where to obtain supplies while you are travelling. When you travel across time zones, make sure that the time and date 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 WARNING You must ensure that the Bluetooth ® function is switched off before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. See section 6.2 Switching Bluetooth ® ON and OFF
643.2 Interruption of insulin pump therapyConsult with your doctor or healthcare team about when and for how long your insulin pump therapy can be interrupted. Measure your blood glucose level regularly during any insulin interruption. Use a syringe or insulin pen to inject insulin according to the instructions of your doctor or healthcare team.w WARNING Because only rapid-acting insulin is used for insulin pump therapy, only a small amount of insulin is stored in the body. If insulin delivery is interrupted for any reason – such as:If you stop the pump jThere is a technical problem with the pump jThe cartridge is leaking and /or the infusion set is leaking jThere is occlusion in the infusion set or in the headset jThe cannula has slipped out of the infusion site – jyou must check your blood glucose level and replace themissing insulin immediately.
6531. 2.3.2.1 Short interruptions3.Press d to move to the STOP YOUR PUMP screen. Press f to put your pump in STOP mode. Remove the infusion set or, when using a disconnectable infusion set, disconnect the transfer set from the headset and use the protective covers that came with it.Resuming insulin deliveryReconnect or reinsert your infusion set and put your pump into RUN mode.1. Where appropriate, attach a new Accu-Chek infusion set. (See section 3.4 Changing the infusion set)Measure your blood glucose level within two hours of restarting pump therapy to check the function of the system and to ensure insulin delivery.
66When you need to interrupt your pump therapy for more than one day, use the following procedure.1.Put your pump into STOP mode.Remove the cartridge, adapter, and infusion set.Remove the battery and reinsert the battery cover.Store your pump properly. See section 7.6 Storing your pump.2. 3.3.2.2 Long interruptions
6733.3 Your insulin pump and waterc CAUTION Before any contact with water, disconnect and take off your Accu-Chek Spirit Combo insulin pump. Check your pump daily to ensure that it is not chipped, cracked or damaged in any way, and that the battery cover and the adapter are correctly closed. Otherwise water, dust, insulin, or other substances may enter your pump and lead to malfunction. Disconnect and remove your pump before taking a bath, or going into a whirlpool, shower or swimming pool. Avoid exposing your pump to high humidity, such as in a sauna, as this could result in damage. To make it easy to remove your pump, use disconnect-able Accu-Chek infusion sets.3.3.1 Accidental contact with waterYour Accu-Chek Spirit Combo insulin pump is protected against brief accidental contact with water. Examples of accidental water contact include:j Rain j Water splashes while you are cycling, jogging or hikingj Accidental immersion in the sink, washbasin or bath
68What to do after any water contactPut your pump into STOP mode, disconnect the pump from your body, and inspect it. Use a soft cloth to dry the outside of the pump, and check the battery compartment and the cartridge compartment for water. If the battery compartment or cartridge compartment are wet, turn your pump upside down to let the water run out and leave it to dry. Do not use warm air such as a hair dryer to dry the pump, as this could damage the pump’s housing. Do not reinsert the battery or the cartridge until the compartments are completely dry. See section 7.5.1 Cleaning your pump. Other liquidsYou do not need to worry about contact between your pump and perspiration or saliva. You must however check your pump immediately after contact with other liquids or chemicals such as:Cleaning solutions jAlcohol jBeverages jOil or fat jSee section 7.5 .1 Cleaning your pump. c CAUTION Avoid any contact between your Accu-Chek Spirit Combo insulin pump, the infusion set, and the connecting parts of your insulin pump with health and beauty products (for example: antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or other cosmetics). These substances could discolor your pump or fog the display.
6933.4 Changing the infusion setWhen you change the infusion set, keep the following information in mind:Infusion sets are jsterile products intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the package is damaged.Correctly tighten the infusion set onto the adapter to avoid jleakage. Turn the infusion set luer-lock connector until it stops. Do not turn it any further and do not use auxiliary tools, as this may crack the infusion set luer-lock connector and result in leakage.Your pump cannot detect infusion set jleakage. You should inspect all parts of your infusion set regularly during the day and before you go to sleep. If there seems to be any loss of insulin and all parts are correctly tightened, look for and immediately replace a leaking component. Check your blood glucose level immediately, as insulin delivery has been interrupted. Take appropriate action according to your doctor’s or healthcare team’s instructions.Always disconnect your infusion set before changing a jcartridge or priming the infusion set. Otherwise, you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set and cartridge system you are using.
703.Disconnect the transfer set from the headset.Remove the infusion set from the adapter and dispose of it correctly.Tip: The battery key has a notch that ts all Accu-Chek infusion set luer-lock connectors. You can use this tool to loosen the luer-lock connector from the adapter if it cannot be loosened by hand.5.4.Procedure for changing the infusion set Have the following materials ready:Your Accu-Chek Spirit Combo insulin jpumpA disinfectant for your skin jA new Accu-Chek infusion set j2.1.Make sure your pump is in STOP mode.Wash your hands thoroughly.
7137.Remove the used infusion headset and dispose of it correctly.Carefully prepare a new Accu-Chek infusion set for use.Screw the Accu-Chek infusion set clockwise into the adapter.Carefully tighten the luer-lock connector by hand.6. 8.9. 10. 11.Prime the infusion set following the instructions found in section 2.8 Priming the infusion set. Prepare the infusion site and insert a new infusion set following the instructions in section 2.9 Positioning the infusion set.Put the pump in RUN mode. See section 2.10 Starting insulin delivery.
72Note If you use a soft cannula-type infusion set, you must begin with a bolus to ll the air space in the cannula after removing the introducer needle, according to the instructions for the infusion set you are using. Failure to do so could result in inadequate insulin dosing. See section 4.2 Programming a Standard Bolus. w WARNING Inspect your infusion site at least twice each day for irritation or infection. Signs of infection may include, but are not limited to: pain, lumps, redness, heat, or discharge. If you see redness or swelling, change the infusion headset and the infusion site immediately and contact your doctor or healthcare team. Change the headset according to the instructions for the infusion set you are using and your doctor or healthcare team’s recommendations.
7332.1. 3.Make sure your pump is in STOP mode.Wash your hands thoroughly. Remove the transfer set from the headset.Procedure for changing the cartridge and infusion set3.5 Changing the cartridge and infusion setHave the following materials ready:Your Accu-Chek Spirit Combo insulin pump jA disinfectant for your skin jA new Accu-Chek infusion set jA lled Accu-Chek Spirit 3.15 ml Cartridge System jA new adapter (this must be changed at least every jtwo months)
744 . Note Pulling the adapter from the pump casing without completely unscrewing it may result in the plunger staying attached to the piston rod. If this should happen, please call your local pump support (see inside back cover).Hold your Accu-Chek Spirit Combo insulin pump with the adapter pointing down-ward.6.Remove the transfer set from the adapter and dispose of it correctly. Remove the cartridge from the adapter and dispose of the cartridge properly.Tip: The battery key has a notch that ts all Accu-Chek infusion set luer-lock connectors. You can use the battery key to loosen the luer-lock connector between your infusion set and adapter.7.5.Remove the adapter and cartridge from your pump by unscrewing the adapter from the pump casing.
75310.Insert a new cartridge and a new infusion set. See section 2.7 Inserting the cartridge.9.Hold the adapter up to the light to check for signs of wear or dirt (especially on the seals inside and outside of the adapter). If necessary, clean the adapter using water and dry it. If it shows signs of wear or dirt, replace it immediately.8.
763.6 General safety information w WARNING Always carry spare sterile products and accessories (infusion set, insulin cartridge, batteries), an insulin pen/syringe, and insulin. Without insulin, hyperglycemia or diabetic ketoacidosis may develop and may require in-patient hospital treatment.c CAUTION Do not place your insulin pump in direct sunlight. Overheating of the insulin and the pump must be avoided. Protect your insulin pump from direct exposure to cold wind and tempera-tures over 104 °F (40 °C) and below 41 °F (5 °C). These conditions may damage the insulin and the housing of your insulin pump, and could also cause a malfunction of the battery. See the instructions for the insulin you are using to determine the acceptable temperature range.Note Check the amount of insulin remaining in the cartridge at least once a day. Press f from the RUN or STOP screen to display the remaining cartridge content in units. Before going to sleep, make sure that:The pump is in RUN mode jThe cartridge contains enough insulin to last through jthe nightThe battery level is OK jThe time and date are set correctly j
7744.1 Understanding bolusesA bolus is the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus type and amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake, your health condition, and your activity level. Discuss the timing, the amount and type of bolus you need with your doctor or healthcare team. Your pump can deliver three types of bolus: Standard Bolus fast deliveryExtended Bolus delivery over a programmed period of timeMultiwave Bolus combines fast delivery with delivery over a programmed period of time4 Boluses and Temporary Basal Rates
784.2 Programming a Standard BolusThere are two ways to program a Standard Bolus:Quick Bolus Using a and s on your insulin pump, with bolus increments determined by the userUsing Standard Bolus menuUsing d and f to enter the menu and then a and s to program the amountThe bolus amount per delivery is limited to 50 units.After you program a Standard Bolus, there is a delay of 5 seconds before bolus delivery starts. This delay allows you to cancel the bolus by pressing the a or s key if desired. The Warning W8: BOLUS CANCELLED is displayed. Press f twice to conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CAN-CELLED.
7944.2.1 Programming a Quick BolusThe following process uses only the a and s keys. You can start with either key. The recommended steps below are those described the Down key s in step 1 and the Up key a in Step 2. For the alternative step, you can use the Up key in step 1 and the Down key in step 2.Because your pump beeps and vibrates to guide you through the programming steps, you can program the Quick Bolus without 1. 2.Procedure for programming a Quick BolusFrom the RUN screen, press and hold s until you hear a beep sequence and feel a vibration. This activates the Quick Bolus function.Press a once for each increment until the required bolus amount is reached. You must not use the s key.looking at the pump screen. After the bolus is programmed, you can count the beeps and vibrations of your pump to check the correct programming. For safety reasons, you should also check the display as long as you are less experienced with the pump.The factory setting for the increment of the Quick Bolus is 0.5 units. You can set the increment to 0.1, 0.2, 0.5, 1.0 or 2.0 in your Therapy Settings. See section 5.10.1 Adjusting the bolus increment.3.With each pressing of the key, your pump beeps and vibrates simultaneously; once for each programmed bolus increment.
80w WARNING The bolus increment that can be programmed into your Accu-Chek Spirit Combo insulin pump determines the Quick Bolus amount using the a and s keys of your insulin pump.Incorrect programming of the bolus increment may cause inappropriate insulin delivery. See section 5.10.1 Adjusting the bolus increment. Five seconds after the last press of a, your pump conrms the total bolus amount with one beep and vibration for each bolus increment programmed. The Standard Bolus symbol blinks for 5 seconds (the bolus delivery start delay). 6.After the bolus delivery start delay, the pump beeps three times and vibrates and then begins to deliver the total bolus amount programmed. A countdown of the remaining bolus amount appears on the display. 5.4.
8144.2.2 Cancelling a Quick BolusDuring programming (the bolus amount blinks): Press the s or a key you used to enter the Quick Bolus programming option. 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 and beeps three times and vibrates after ve seconds. No bolus is delivered.During conrmation (when the beeps and vibrations occur), or During start delay (Standard Bolus symbol blinks): 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 conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.No bolus is delivered.During bolus delivery (countdown of bolus amount): Press and hold s or a for 3 seconds until you hear a melody. A Warning W8: BOLUS CANCELLED is displayed. Press f twice to conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.You can view the actual bolus amount delivered before the cancellation by looking at the bolus history. See section 5.4.1 Viewing your bolus history.Bolus delivery is interrupted. Note Make sure that the cancellation was deliberate, and then program a new bolus, if required.
824.2.3 Programming a Standard Bolus using Standard bolus menuIndependent of the bolus increment setting, the bolus increments for the menu-guided Standard Bolus are xed at 0.1 unit. You can program this bolus in the STANDARD BOLUS screen by holding the a or s key (scrolling) until the bolus amount is displayed. 2. 3.1.Press d to move to the STANDARD BOLUS screen. Press f to select. The BOLUS AMOUNT screen appears. Press or scroll a to increase or s to decrease the bolus amount.Press f to conrm the bolus amount.The Standard Bolus symbol blinks for ve seconds (the bolus delivery start delay). 4.
834After this bolus delivery start delay, your pump beeps three times and vibrates and begins to deliver the total bolus amount programmed. The countdown of the remaining bolus amount appears on the display. 4.2.4 Cancelling a Standard BolusDuring programming (the bolus amount blinks): You have three options for cancelling during programming: j If you do not press any key for 20 seconds after programming the bolus amount, 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. No bolus is delivered.During the start delay (Standard Bolus symbol blinks): 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 conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.No bolus is delivered.During bolus delivery (countdown of bolus amount): Press and hold s or a for 3 seconds until you hear a melody.You can view the actual bolus amount delivered before the cancellation by looking at the bolus history. See section 5.4.1 Viewing your bolus history.Bolus delivery is interrupted.
844.3 Programming an Extended BolusThe Extended Bolus option enables you to program a bolus to be delivered over a period of time. This function is helpful during long meals, dinners, or receptions, or when you have meals that are digested slowly. The Extended Bolus may also be appropriate for people who have gastroparesis (delayed digestion). The duration of bolus delivery can be programmed in 15-minute intervals up to 12 hours and begins immediately after conrma-tion. Throughout the bolus delivery, the remaining time and amount of the Extended Bolus and the current hourly basal rate are displayed in the RUN screen.Cancellation during the start delay and during the bolus delivery will cause a WARNING W8: BOLUS CANCELED. Press f twice to conrm and snooze the Warning. See chapter 8. Note Make sure that the cancellation was deliberate and program a new bolus, if needed.
8541. 2. 3.Procedure for programming an Extended BolusPress d to move to the Extended Bolus screen. Press f to select. The BOLUS AMOUNT screen appears.Press a to increase or s to decrease the bolus amount.The duration of the last Extended Bolus delivered appears. Tip: You can program a Standard or Quick Bolus while an Extended Bolus is ongoing. If you cancel the Standard Bolus, the Extended Bolus continues to run.During the delivery of an Extended Bolus, the programming of another Extended Bolus or a Multiwave Bolus is blocked. If you try to do this, you will receive the Error message: “Bolus currently running”.If you want to program a different Extended Bolus, put the pump in STOP mode to cancel the current bolus. Then put the pump in RUN mode again to program a new Extended Bolus.
86Note If a Temporary Basal Rate is active at the same time as the Extended Bolus, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen.Time ClockCurrent Basal Rate (including TBR where appropriate)Bolus DurationRemaining Bolus4. 5.Press d to move to the BOLUS DURATION screen. Press a to increase or s to decrease the bolus duration.Tip: Press d to switch between programming the bolus amount and bolus duration.Press f to conrm the bolus amount and duration. The pump returns to the RUN screen. The bolus delivery begins within the next 3 minutes.
8744.3.1 Cancelling an Extended BolusDuring programming (the bolus amount or bolus duration blinks): You 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.No bolus is delivered.During bolus delivery j If the Extended Bolus delivery has begun, it can be cancelled by putting your pump into STOP mode. This cancels the bolus delivery and a Warning W8: BOLUS CANCELLED is displayed. Press f twice to conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED. Put your pump back in RUN mode afterwards. The bolus amount delivered up to the cancellation can be reviewed in the BOLUS HISTORY screen. See section 5.4.1 Viewing your bolus history.Bolus delivery is interrupted.
88Note If a Temporary Basal Rate is active at the same time, it is also cancelled when your pump is put into STOP mode. A Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED are displayed. Press f twice to conrm and turn off the rst Warning. The second alert appears on the display. Press f twice to conrm and turn off the second Warning. Both alerts are recorded in the Warnings history. S e e chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED. Make sure that the cancellation was deliberate and then program a new Extended Bolus (and /or Temporary Basal Rate) if needed.
8944.4 Programming a Multiwave BolusThe Multiwave Bolus option is available in the ADVANCED user menu. It is designed to better simulate the body’s insulin delivery, and combines an immediate bolus delivery followed by an Extended Bolus delivery. This option can be helpful when you have meals that include both rapidly and slowly absorbed carbohydrates. The duration of bolus delivery can be programmed in 15-minute intervals for up to 12 hours. Note j The Multiwave Bolus is available only in the ADVANCED user menu. You can add a jStandard Bolus to an ongoing Multiwave Bolus. If you cancel the Standard Bolus, the Multiwave Bolus remains running. During the delivery of a jMultiwave Bolus, the program-ming of a second Multiwave Bolus or an Extended Bolus is blocked. If you need a different Multiwave Bolus, put your pump in STOP mode to cancel the current bolus and program a new one.When programming a Multiwave Bolus, make sure that you are using the ADVANCED user menu and your pump is in RUN mode.
90Procedure for programming a Multiwave Bolus1. 2. 3.5.Press d to move to the Multiwave Bolus screen.Press f to select. The BOLUS AMOUNT screen appears. Press a or s to increase or decrease the total bolus amount.Note The rst time you press a, the bolus duration of the last Multiwave Bolus and a default immediate bolus amount appear. The latter increases or decreases proportionally as you increase or decrease the total bolus amount. Press d to move to the IMMEDIATE BOLUS screen. Press a or s to correct and set the immediate bolus amount.Press d to move to the BOLUS DURATION screen. Press a or s to correct and set the Extended Bolus duration in increments of 15 minutes for up to 12 hours.4.
9146.Tip: Press d to loop between program-ming the total BOLUS AMOUNT, IMMEDI-ATE BOLUS and BOLUS DURATION.Check the total and immediate bolus amounts and the Extended Bolus duration programmed on the screens. Press f to conrm both bolus amounts and the bolus duration. The Multiwave Bolus symbol blinks for 5 seconds (bolus delivery start delay). 8.The pump beeps three times and vibrates. The immediate bolus delivery begins. The countdown of the remaining bolus continues to appear on the display.Note If a Temporary Basal Rate is active at the same time, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed on the RUN screen.7.
924.4.1 Cancelling a Multiwave BolusDuring programming (the bolus amount blinks): There are three 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. No bolus is delivered.During the start delay (Multiwave symbol blinks): j Press s or a. The pump beeps and vibrates. The pump returns to the RUN screen. No bolus is delivered.During immediate bolus delivery j You can cancel immediate delivery by pressing and holding s or a for 3 seconds until you hear a melody. This cancels the whole bolus (immediate and Extended Bolus delivery).Bolus delivery is interrupted. During extended delivery j You can cancel the extended delivery by putting the pump in STOP mode. This cancels the Extended Bolus. Bolus delivery is interrupted. Cancellation of the bolus during start delay, immediate bolus delivery and extended delivery will cause a Warning W8 BOLUS CANCELLED. Press f twice to conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED. You can review the actual bolus amount delivered before the cancellation by looking at the bolus history. See section 5.4.1 Viewing your bolus history.
934Note If a Temporary Basal Rate is active at the same time, it is also cancelled when your pump is put in STOP mode. The Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED is displayed. Press f twice to conrm and turn off the rst Warning. The second Warning appears on the display. Press f twice to conrm and turn off the second Warning. Both Warnings are recorded in the alarm history. See chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED. Make sure the cancellation was intended and then put the pump back in RUN mode and program a new Multiwave Bolus (and / or Temporary Basal Rate), if needed.4.5 Programming a Temporary Basal Rate (TBR)Your pump allows you to temporarily increase or decrease your basal rates. This enables you to match your changing insulin needs due to increased or decreased activity level, illness, or stress. Typically, a basal rate is set to 100 %, but you can: Increase it to 250 % for up to 24 hours jDecrease it to 0 % for up to 24 hours jWhen you increase or decrease your basal rate, each hourly basal rate for the duration you program is increased or de-creased automatically. The characteristic shape of your basal rate prole remains and does not become a at curve, if the change is larger than 0 %. For 0 % the basal rate prole becomes a at line and no insulin (except boluses) is delivered during the programmed duration. Discuss programming a Temporary Basal Rate with your doctor or healthcare team.
94Note A running Temporary Basal Rate increase or decrease remains active, even if you have changed the basal rate prole.You can only program a Temporary Basal Rate when your pump is in RUN mode.Procedure for programming a Temporary Basal Rate 1. 2.Press d to move to the TEMPORARY BASAL RATE (TBR) screen.Press f to select. The TBR PERCENTAGE screen appears.Note If no Temporary Basal Rate is currently active, the percentage is set to 100 %. If a Temporary Basal Rate is active, its duration and percentage appear on the RUN screen.
9544.Press a or s to increase or decrease the basal rate.Tip: When you increase (or decrease) the Temporary Basal Rate, the duration of your previous Temporary Basal Rate increase (or decrease) appears. However, when you use your pump for the rst time, a default value appears.Press d to move to the TBR DURATION screen. Press a or s to correct and set the duration.3.5.Tip: You can switch between program-ming the basal rate percentage and duration by pressing d.Press f to save and exit. The new Temporary Basal Rate is immediately activated.When a Temporary Basal Rate is active, the pump emits a beep and vibrates once every hour.
96Note During Temporary Basal Rate delivery, the increase or decrease in percentage, the increased or decreased hourly basal rate (hourly basal rate plus TBR percentage), and the remaining time are displayed in the RUN screen. An arrow pointing upward symbolizes a Temporary Basal Rate increase; an arrow pointing downward symbolizes a Temporary Basal Rate decrease.Note If an Extended Bolus or a Multiwave Bolus is active at the same time, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen. Example: Extended Bolus running TBR OVER AlertAt the end of a Temporary Basal Rate, a Warning W7: TBR OVER is displayed. Press f twice to conrm and turn off the Warning. See chapter 8 Warning W7: TBR OVER.Remaining durationExtended Bolus symbol
974During programming: There are three 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 a + d simultaneously. j Set the TBR percentage to 100 %. Press f to save and exit. Pump continues to deliver normal basal rate.During delivery: There are two 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 delivery is cancelled, as well as any Extended or Multiwave Bolus that is currently running. A Warning W6: TBR CANCELLED is displayed. Press f twice to conrm and turn off the alert. Put your pump back in RUN mode.Pump returns to normal basal rate. 4.5.1 Cancelling a Temporary Basal Rate
98Note If an Extended Bolus or a Multiwave Bolus is active at the same time, it is also cancelled when your pump is put into STOP mode. A Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED are displayed. Press f twice to conrm and turn off the rst alert. The second alert appears on the display. Press f twice to conrm and turn off the second alert. Both alerts are recorded in the alarm history. See chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED. Make sure that the cancellation was intended and put your pump back in RUN mode and then program a new Temporary Basal Rate (and /or an Extended or Multiwave Bolus), if needed. 4.6 General safety informationw WARNING j Incorrect programming of your insulin pump may cause inappropriate insulin delivery.j Your insulin pump must be programmed with your personal settings before starting insulin pump therapy. j Do not operate your insulin pump without knowing your personal settings. j If you are not sure about your personal settings, or you are less experienced, ask your doctor or healthcare team to check your personal settings. j Work with your doctor or healthcare team to determine the timing, amount, and type of bolus you need to deliver. j Make sure you know your personal carbohydrate-to-insulin ratio and your correction factor.w WARNING When your pump is in STOP mode it does not deliver insulin. Put the pump in RUN mode to continue insulin delivery.
995This chapter explains how to use the available menu options, and to personalize your pump to match your level of experience with insulin pump therapy.5.1 IntroductionUsing the four keys on the pump, and their combinations, you can access the menu options and their relevant screens. This enables you to, for example:Program the pump jPerform a function jChange a setting jStore information jNote Your Accu-Chek Spirit Combo insulin pump has been designed for use with the Meter. This “intelligent” blood glucose meter enables you to communicate with the pump using Bluetooth ® wireless technology.5.1.1 User menusYour Accu-Chek Spirit Combo insulin pump has been designed to adapt to your level of experience in pump therapy – whether you are a beginner or an experienced pump user. Your Accu-Chek Spirit Combo insulin pump “grows” with you!You can use one of three menus – STANDARD, ADVANCED or CUSTOM – to access the functions and settings you will need from day to day.5 Personalizing your pump
100STANDARD This menu provides all the basic functions you need for successful pump therapy. If you are new to pump therapy, we recom-mend that you start with this menu. As you become more experienced, you may wish to change to the ADVANCED user menu.ADVANCED This menu provides the complete range of the Accu-Chek Spirit Combo insulin pump functions. It includes all the functions from the STANDARD user menu, plus a wide range of functions for the more experienced user.CUSTOM Because the Accu-Chek Spirit Combo insulin pump has so many features, you may want to decide which screens are displayed when you scroll through the menu choices. Using appropriate PC software, this menu enables you to hide screens of the ADVANCED user menu and thereby customize your pump.At the beginning of this User Guide, you will nd fold-out diagrams of the STANDARD, CUSTOM and ADVANCED user menus.Note For your safety and convenience during programming, your Accu-Chek Spirit Combo insulin pump returns to the RUN or STOP screen if no key is pressed within 20 seconds. The changes you made before your pump timed out will not be saved.
10155.2 Selecting a user menuNote For guidance in choosing the most suitable user menu, see section 5.1.1 User menus. If you are still not sure which menu to choose, discuss this with your doctor or healthcare team.2. 3.Procedure for selecting a user menuThe SELECT USER MENU screen is displayed.Press a or s to select a user menu.Press f to conrm. The selected basal rate prole and its daily insulin total appear, or …1.Press d to move to the MENU SETTINGS screen.Press f to select.
1025.Press a or s to select a basal rate prole, if required.Check the (new) basal rate prole and its daily insulin total.Press f to save and exit. The new user menu and basal rate prole are active immediately.c CAUTION A running increased or decreased Temporary Basal Rate will remain active, even if you change the basal rate prole. The Temporary Basal Rate is based on the new basal rate.4.… if the previous basal rate prole is not available from the selected user menu, dashes appear instead.
10355.3 STANDARD user menuThe following is a list of menu options from the STANDARD user menu. To view the order in which they appear on the display, refer to the menu diagram below:Press j d to move forwardPress jd + a simultaneously to move backwardffRUN STOP
104Some of the functions have already been described elsewhere in this User Guide, as listed below. The remaining functions are described following the list.TIME AND DATE SETTINGSSee section j2.4 Setting the time and date.BASAL RATE PROGRAMMINGSee section j2.5.1 Programming your basal rate prole.CARTRIDGE CHANGESee section j2.7 Inserting the cartridge.Infusion set PRIMING See section j2.8 Priming the infusion set.START YOUR PUMPSee section j2.10 Starting insulin delivery.STOP YOUR PUMPSee section j2.11 Stopping insulin delivery.Quick BolusSee section j4.2.1 Programming a Quick Bolus.STANDARD BOLUSSee section j4.2 Programming a Standard Bolus.EXTENDED BOLUSSee section j4.3 Programming an Extended Bolus.TEMPORARY BASAL RATE (TBR)See section j 4.5 Programming a Temporary Basal Rate (TBR).MENU SETTINGSSee section j5.2 Selecting a user menu earlier in this chapter.BLUETOOTH SETTINGS See chapter j6 Using the Accu-Chek Spirit Combo insulin pump with the Meter.
10555.4 Viewing your pump dataThe memory of your Accu-Chek Spirit Combo insulin pump stores all the events (Warnings and Errors, programming operations and insulin delivery records) up to 4500 events. This data corresponds to about the last ninety days of use, and can be accessed on a personal computer using Accu-Chek software products.The following data can be reviewed directly on your Accu-Chek Spirit Combo insulin pump:Bolus history last 30 bolusesAlarm history last 30 Warnings and ErrorsHistory of daily insulin totalslast 30 daily totals of insulin deliveredTemporary Basal Rate historylast 30 increases and decreases in basal ratePump timer(“Backup” and loaner pumps only)remaining time in days until the pump timer expires
1065.4.1 Viewing your bolus historyThe BOLUS DATA screen allows you to view up to the last 30 bolus deliveries, starting with the most recent entry. Bolus amount / typeBolus timeDate Entry number1. 2. 3.Procedure for viewing the bolus historyPress d to move to the MY DATA screen.Press f to select.The BOLUS DATA screen appears, showing the most recent bolus informa-tion.Press a or s to view the entries.Press f to exit.Each bolus data screen displays:Bolus type (Standard, Extended or Multiwave Bolus) jBolus duration ( – only displayed if an Extended or jMultiwave Bolus)Time jDate jEntry number (01 is the most recent) of total entries j(example 01/30) of a delivered bolusTip: You can enter the BOLUS DATA screen also from the QUICK INFO screen. See section 1.2.3 Display screens.
10755.4.2 Viewing the Error and Warning historyThe alarm data menu allows you to view up to the last 30 Warnings and Errors, starting with the most recent entry.1. 2. 3.Procedure for viewing the alarm historyPress d to move to the MY DATA screen.Press f to select.Press d to move to the ERROR DATA screen.Press a or s to view the entries.Press f to exit.Each alarm data screen displays:Number and type of the Warning or Error (for example, W6) jWarning or Error (for example, TBR CANCELLED) jTime jDate jEntry number (01 is the most recent) of total entries j(example 01/30) of a Warning or Error
1085.4.3 Viewing the history of daily insulin totalsThis function allows you to view up to the last 30 daily totals of insulin delivered (from midnight to midnight; including basal rate plus boluses), starting with the most recent entry.1. 2. 3.Procedure for viewing the daily insulin totalsPress d to move to the MY DATA screen.Press f to select.Press d to move to the DAILY TOTALS screen.Press a or s to view the entries.Press f to exit.Each screen displays:Daily total of insulin delivered jDate jEntry number (01 is the most recent) of total entries j(example 01/04) of a daily insulin total
10953.5.4.4 Viewing the Temporary Basal Rate historyThis option allows you to view up to the last 30 Temporary Basal Rate (TBR) increases or decreases, starting with the most recent entry.1. 2.Procedure for viewing the Temporary Basal Rate historyPress d to move to the MY DATA screen.Press f to select.Press d to move to the TBR DATA screen.Press a or s to view the entries.Press f to exit.Each TBR history screen displays:TBR increase or decrease in percentage jTBR duration jTime jDate jEntry number (01 is the most recent) of total entries (example j01/30) of a delivered Temporary Basal Rate
1105.4.5 Viewing the time remaining (pump timer)For loan pumps and “Backup” pumps, a pump timer limits the operating time. When you begin using the pump, the timer starts the countdown of the number of remaining days.Before the pump timer expires, a Warning will remind you that the operating life of the pump is coming to an end, so that you can arrange to get a new pump in good time. The pump timer 1. 2.symbol appears in the RUN screen or STOP screen. When the timer expires, an Error occurs, and your pump goes into STOP mode. It can no longer be put into RUN mode. See chapter 8 Warning W5: PUMP TIMER and Error E5: END OF OPERATION .Procedure for viewing the time remainingPress d to move to the MY DATA screen.Press f to select.Press d to move to the PUMP TIMER screen.The number of days remaining until the pump timer expires is shown.Press f to exit.Note This setting is country-specic and may not be visible on your pump.
11155.5 Transferring your data to a computer The built-in infrared interface on the bottom of your Accu-Chek Spirit Combo insulin pump enables you to transfer data between your pump and a PC. The memory of your Accu-Chek Spirit Combo insulin pump stores all the events (Warnings and Errors, programming opera-tions and insulin delivery records) up to a total of 4500 events. This data corresponds to about the last ninety days of use, and can be accessed on a personal computer using Accu-Chek 1. 2. 3.Procedure for transferring your datainformation management products (for details see the user information provided with the software).For availability of the appropriate software see Appendix C.Put your pump in STOP mode. Press d to move to the DATA TRANSFER screen.Press f to select.Press f. A melody signals that your pump is ready to transfer data.
1124.When the data transfer is complete, press f to return to the STOP screen.Set up your pump with a cartridge, adapter, and a new infusion set, and put it in RUN mode if necessary.Note Your pump will return to STOP mode 15 minutes after the last data transfer when the DATA TRANSFER screen is selected. You can press twice d and a simultaneously to exit while data is being transferred. The data transfer is interrupted, and the Error E12: DATA INTERRUPTED occurs. See chapter 8.
11355.6 Pump settingsThese settings relate to the practical use of the pump. For settings relating to your therapy, see 5.10 Therapy settings later in this chapter.1. 3.5.6.1 Turning Keylock on and offThe Keylock function allows you to lock the four keys of your Accu-Chek Spirit Combo insulin pump. This is an important safety measure that prevents you from accidentally activating functions, for example while sleeping or during contact sports.If the Keylock is turned on and no key is pressed for 10 seconds after your pump has returned to the RUN screen or STOP screen, all four keys are locked.Procedure for turning the Keylock on or offPress d to move to the PUMP SETTINGS screen.Press f to select.2.The current Keylock status (ON or OFF) appears.Press a or s to turn the Keylock ON or OFF.Press f to save and exit.
1141. 2.From the blank screen, press and hold d and s simultaneously for three seconds. You hear three beeps in RUN or STOP mode when you press the keys and again after three seconds to conrm that the Keylock is unlocked.The Keylock remains unlocked during the programming of the pump.If no key is pressed for 10 seconds after your pump has returned to the RUN or STOP screen, all four keys are automati-cally locked.Procedure for unlocking the KeylockIf you press any key while the screen is blank, the Keylock symbol indicates that the keys are locked.Note The Keylock remains unlocked during fast bolus delivery of Standard or Multiwave Bolus.
11555.6.2 Adjusting the sound volumeYour pump emits different acoustic signals in different handling situations to facilitate handling e.g. for blind or partially-sighted users. For details on the meaning of the sound patterns, see the Appendix “Beeps and melodies”. You can adjust the volume of the beeps according to your personal preference. There are ve volume levels available: off, low, medium, high and maximum.1. 2.Note The volume of the STOP-Warning is independent of the programmed beep volume – it always sounds at the maximum level. If the beeps are turned off, and a Warning or Error occurs, the beeps become active again to ensure that you are aware of the Warning or Error. If the Warning or Error is not cancelled, the beeps gradually increase in volume until the maximum level is reached.Procedure for adjusting the sound volumePress d to move to the PUMP SETTINGS screen.Press f to select.Press d to move to the SOUND VOLUME screen.Press a or s to adjust the sound volume.Press f to save and exit.
1165.6.3 Changing signal settingsThe Accu-Chek Spirit Combo insulin pump enables you to choose how you want your pump to alert you when a Warning or Error occurs.You have three options:Procedure for changing the signal settingsBeep onlyVibrate onlyBeep and vibrateFor your safety, if you do not respond to the vibration, the pump starts beeping after one minute.1. 2.Press d to move to the PUMP SETTINGS screen.Press f to select.Press d to move to the SIGNAL SETTINGS screen.Press a or s to set the signals.Press f to save and exit.
11755.6.4 Display orientationYour pump allows you to turn the display by 180°, so that you can view it more easily, depending on how you are wearing the pump.1. 2. 3.Procedure for setting the display orientationPress d to move to the PUMP SETTINGS screen.Press f to select.Press d to move to the ORIENTATION screen.The current orientation is displayed.Press a or s to select the display orientation.Press f to save and exit.Note If you turn the display orientation of your pump by 180°, the functions of the a or s keys are also reversed. The functions of the d and f keys remains the same, whichever screen orientation you choose.
1181. 2.5.6.5 Setting the display contrastYour pump allows you to adjust the display contrast to suit your preferences.Procedure for setting the display contrastPress d to move to the PUMP SETTINGS screen.Press f to select.Press d to move to the DISPLAY CONTRAST screen.Press a or s to select the desired contrast level.Press f to save and exit.
11951. 2.5.6.6 Selecting the languageYour pump can display the information in several languages. You can chose the language according to your preferences.Procedure for setting the languagePress d to move to the PUMP SETTINGS screen.Press f to select.Press d to move to the LANGUAGE screen.Press a or s to select a language.Press f to save and exit.
1205.7 ADVANCED user menuThe following is a list of additional menu options available in the ADVANCED user menu. To view the order in which they appear on the display, refer to the menu diagram below:BRP 4BRP 3BRP 2BRP 4BRP 3BRP 2ffRUN STOPPress j d to move forwardsPress jd + a simultaneously to move backwardsBRP = Basal Rate prole 2 – 4
1215Note The ADVANCED user menu contains all the options from the STANDARD user menu. Some of the functions are described elsewhere in this User Guide, as listed below. The remaining functions are described in this chapter following the list.Multiwave BolusSee section 4.4 Programming a Multiwave Bolus.5.8 Basal rate proles Your pump has ve different basal rate proles to match your changing insulin needs (for example, Monday to Friday or Exercise Day or Sleeping Late Day). However, in the Standard User menu only the basal rate prole 1 is accessible.Discuss additional basal rate proles with your doctor or healthcare team. Also, consult with your doctor or healthcare team before changing basal rate proles, as this may affect how you use your pump.5.8.1 Programming additional basal rate prolesw WARNING Your Accu-Chek Spirit Combo insulin pump must be pro-grammed with your personal settings prior to starting insulin pump therapy. Do not operate your pump without knowing your personal settings. If you are not sure about your personal settings or you are inexperienced, ask your doctor or healthcare team to check your personal settings.
1221. 2.Procedure for Programming additional basal rate prolesPress d to move to the BASAL RATE PROGRAMMING (1, 2, 3, 4, 5) screen you wish to program. Press f to select.The hourly basal rates for each additional basal rate prole are set in the same way as for basal rate prole 1. See section 2.5.1 Programming your basal rate prole.Note Only basal rate proles that are accessible in your current user menu are available. If the basal rate prole number(s) do(es) not appear, select the ADVANCED user menu, or program the basal rate prole to an available basal rate prole number.
12351. 2.5.8.2 Selecting a basal rate prolePress a or s to select a basal rate prole. The selected basal rate prole and its daily insulin total appear. Press f to select.The new basal rate prole is active immediately.Note Only basal rate proles that are accessible in your current user menu are available. A running Temporary Basal Rate increase or decrease stays active, even if you change the basal rate prole on your pump.Press d to move to the BASAL RATE SELECTION screen.Press f to enter.Procedure for selecting a basal rate prole
1245.9 Setting a ReminderYou can set both single and multiple Reminders on your pump. Multiple Reminders are repeated at a set time every day. You can use this feature to remind you, for example, when you need to test your blood glucose.1. 2. 3.Procedure for setting single or multiple RemindersPress d to move to the REMINDER SETTINGS screen.Press f to select. The current REMINDER status and alarm time appear.Press a or s to change the REMINDER setting to OFF, ONCE or EVERY DAY.
12554.Press d to move to the HOUR screen.Press a or s to set the hour.5.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 conrm and return to RUN or STOP mode (See also section 8.4 reminder).
1265.10 Therapy settingsThese settings relate to the therapeutic use of the pump. For settings relating to the practical use of the pump, see Pump settings earlier in this chapter.5.10.1 Adjusting the bolus incrementDesigned for those patients who may need large or small amounts of insulin, the bolus increment for the Quick Bolus of your Accu-Chek Spirit Combo insulin pump is adjustable. It is initially set to 0.5 units per key-press, but it can be changed to 0.1, 0.2, 0.5, 1.0 or 2.0 units. w WARNING The bolus increment determines the Quick Bolus amount per key press using the a and s keys. Incorrect programming of the bolus increment may cause inappropriate insulin delivery.1. 2.Procedure for adjusting the bolus incrementPress d to move to the THERAPY SETTINGS screen.Press f to select.Press d to move to the BOLUS INCREMENT screen.Press a or s to select a bolus increment.Press f to save and exit.
12755.10.2 Adjusting the prime amountThe prime amount needed to ll an infusion set depends on the length of the infusion set tubing. The shorter your infusion set tubing, the less insulin will be required to prime the infusion set. The default setting for the prime amount is 25 units of insulin.Note The amount of insulin used for the priming is not added to the history of daily insulin totals.1. 2.Procedure for adjusting the prime amount Press d to move to the THERAPY SETTINGS screen.Press f to select.Press d to move to the PRIME AMOUNT screen.Press a or s to select a prime quantity between 0.0 and 50.0 units.Press f to save and exit.
1285.10.3 Locking basal rate prolesYour Accu-Chek Spirit Combo insulin pump allows you to adapt your hourly basal rate prole as needed. You can then lock your basal rate proles to provide additional protection against accidentally changing a basal rate during normal operation. If the basal rate lock is set to ON, programming of the basal rate proles 1, 2, 3, 4 and 5 is blocked.If you try to program a basal rate while the BASAL RATE LOCK is turned ON, the key symbol in the BASAL RATE TOTAL screen indicates that basal rate programming is locked. The a and s functions are blocked. However, you can still change between the different basal rate proles 1 to 5.Procedure for locking the basal rate proles1. 2.Press d to move to the THERAPY SETTINGS screen.Press f to select.Press d to move to the BASAL RATE LOCK screen.Press a or s to turn the basal rate lock ON or OFF.Press f to save and exit.
12955.10.4 Automatic OffAutomatic Off is a safety feature that stops insulin delivery and triggers Error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. This feature can either be 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 or healthcare team.1. 2. 3.Procedure for using Automatic OffPress d to move to the THERAPY SETTINGS screen.Press f to select.Press d to move to the AUTOMATIC OFF screen.Press or scroll a to increase or s to decrease the duration for the Automatic Off in 1-hour intervals.If you would like to set the Automatic Off function to off, press s until “0 hours” and OFF appear on the display.Press f to save and exit.
1305.11 CUSTOM user menu The CUSTOM user menu is designed to adapt your pump to your special requirements and preferences. It allows you or your doctor or healthcare team to display or hide screens and thereby customize the individual user menus.Press j d to move forwardPress jd + a simultaneously to move backwardffRUN STOP
1315Note By default, the CUSTOM user menu contains all of the functions available except the following:Multiwave Bolus j jBasal rate proles 3, 4 and 5To change the CUSTOM user menu, you, your doctor, or your healthcare team must use the appropriate Accu-Chek PC software.
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13366 Using the Accu-Chek Spirit Combo insulin pump with the MeterThis chapter describes how the Accu-Chek Spirit Combo insulin pump works with the Meter, and explains how to pair the two devices using Bluetooth ® wireless technology. Note In this User Guide the term “Meter” always refers to the Accu-Chek Aviva Combo Blood Glucose Meter.“Pairing” means to set up a connection between the two devices using Bluetooth ® wireless technology. This is a secure connec-tion, and there is no risk of your pump receiving signals from any other device.Note The pump may not communicate with the Meter using Bluetooth ® wireless technology when the devices are more than two meters (about six feet) apart.6.1 MeterThe Meter is both a blood glucose meter and a remote-control device for your Accu-Chek Spirit Combo insulin pump. Using the Meter, you can program your pump without handling it, and also receive bolus advice and review history information. Note Do not leave your Meter unattended as long as it is connected to your pump. Otherwise your pump could be manipulated remotely without your control (for example: children playing with the Meter).
1346.1.1 Tasks that must be performed on the pumpThe following tasks cannot be performed remotely using the Meter:Changing the cartridge j jPriming the infusion setData transfer jBluetooth j® settingsDisplay settings jAll the other functions available on the Accu-Chek Spirit Combo insulin pump can be performed using the Meter.Before using your pump together with the Meter you must read the documentation (Owner’s Booklet) provided with this product.
13566.2 Switching Bluetooth ® ON and OFFw WARNING You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. 1. 2.To prolong the battery life and avoid accidental changes on your pump, you should switch off Bluetooth ® wireless technology, if the Meter is lost, stolen or, you plan not to carry it with you for a longer period of time.Procedure for switching Bluetooth ® ON and OFFPress d to move to the BLUETOOTH SETTINGS screen.Press f to select to the ON / OFF screen.Press a or s to switch on the Bluetooth ® function.Press f to save and exit.
1366.3 Pairing your pump with the MeterIf you have already acquired the Meter together with the Accu-Chek Spirit Combo insulin pump, the two devices will already have been paired. When pairing your Accu-Chek Spirit Combo insulin pump with the Meter, place both devices on a table or desk, so that you can see the displays of both devices clearly.1. 2. 3.Procedure for PairingPress d to move to the BLUETOOTH SETTINGS screen.Press f to select to the ON / OFF screen.Press a or s to switch on the Bluetooth ® function.Press d to display the PAIRED DEVICE screen.You should not perform the pairing process in crowded areas, since the signals of other electronic devices could interfere with the connection.
13766.Pump screenMeter screen4.Pump screenMeter screen5.Note When Bluetooth ® is turned off, you cannot access the Paired Device menu.If the pump screen indicates that no paired device is available, turn on the Meter in pairing mode by holding down * and simultaneously pressing +.Press the d key on the pump to see the ADD DEVICE screen, and press f to initiate pairing.The pump begins searching and detects the Meter, displaying its serial number (This process may take several minutes).Press a or s to select the number, which is also shown on your Meter screen. Press f on the pump to conrm that you want to pair the Meter.
1387.9.8.The pump begins the pairing process and shows a 10-digit code. Enter the code on the Meter display, using =, x and z and then = to move to the next digit.Conrm the complete code with ..10.Pump screenMeter screenMeter screenAfter the pairing is completed press + to turn off the Meter.The pump now shows the DEVICE PAIRED screen. Press f to conrm the pairing.The pump displays the PAIRED DEVICE screen. You can return to the RUN screen by pressing f.If the pairing is not successful in a rst attempt, wait a few minutes before you repeat the procedure in a safe or less crowded environment.
13966.4 Troubleshooting the Bluetooth ® connectionIn case of problems with the Buetooth connection or after the appearance of the W10: BLUETOOTH FAULT, you have to repeat the pairing procedure described in section 6.3 Pairing your 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 a new Meter.1. 2. 3.Press d to move to the BLUETOOTH SETTINGS screen.Press f to enter the BLUETOOTH ON / OFF screen.Press d to move to the PAIRED DEVICE screen.
1404.Press d to move to the DELETE DEVICE screen. Press f once to delete the pairing and a second time to conrm.Then repeat the pairing procedure described in section 6.3 Pairing your pump with the Meter.If the pairing is still not successful, contact local pump support (details on inside back cover).6.4.1 Handling Warnings and ErrorsThe Accu-Chek Spirit Combo insulin pump and Meter behave in the following ways when Warnings and Errors occur.If both devices are switched on and paired you can enter the jMeter’s Pump menu and snooze and conrm the Warning or Error through the Meter. If the Meter is switched off, and you switch it on in response to ja Warning, Error or Reminder on the pump, the Meter switches immediately to the Pump menu. All the functions available on the pump are performed from the Pump menu of the Meter. Note The above points do not apply in the case of E7: ELECTRONIC ERROR.
14166.4.2 Use in aircraftw WARNING You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft.
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1437This chapter explains how to take care of your pump and keep it properly maintained.GuaranteeDisetronic Medical Systems Inc. guarantees that your pump functions according to its specications only where all servicing of your pump is carried out and / or authorized by Disetronic Medical Systems.c CAUTION Do not perform any servicing or repair on your Accu-Chek Spirit Combo insulin pump. For servicing or repair, contact your local pump support (see inside back cover). 7.1 Inspecting your pumpYour pump must be properly maintained to guarantee accurate insulin delivery. Check the pump display regularly during the day and before you go to sleep, and especially if for any reason you might not be able to hear the beeps or feel the vibrations. AccessoriesUse only Accu-Chek sterile products and accessories designed to be used with your pump. Replace and discard these items according to your doctor’s or healthcare team’s recommenda-tions and the instructions that come with these items. 7 Care and Maintenance
1447.1.1 ChecklistCheck your pump daily, and make sure that:The pump casing, the display, and the cartridge are not jchipped or cracked and that the display does not show incomplete or abnormal letters or symbols.You carefully inspect the cartridge. Make sure that the actual jamount of insulin in the cartridge equals the displayed cartridge amount on the Quick Info screen. You inspect all parts of your pump and infusion set regularly jduring the day and before you go to sleep. If you detect any loss of insulin, immediately replace the leaking component. The battery cover is correctly tightened and positioned, in line jwith the pump casing. The adapter is correctly attached. jYour infusion set is primed, free of air bubbles, and tightly jconnected to the adapter. Your infusion set is inserted according to the instructions for jits use. Your infusion site is secure, comfortable, and free of irritation jor infection. The cartridge is free of air bubbles. jYour pump is in RUN mode. jThe basal rates are set correctly according to your doctor’s or jhealthcare team’s recommendations. The time and date are set correctly. jThe Temporary Basal Rate changes are set according to your jdoctor’s or healthcare team’s recommendations. The beeps and / or vibrations are set. jYou have your personal jemergency kit with you. (See section 1.5 Emergency kit)
14577.2 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 seal that protects it against water. Use the specially designed pump carrying system to help avoid dropping your pump. See Disetronic Medical Systems sterile products and accessories catalogs and brochures for more information, or contact your local pump support (details on inside back cover). If you drop your pump:Check that all the connections in your infusion set are still jtight, and if they are not, reconnect or tighten them Check your pump, its jsterile products, and accessories for chips and cracks Change the cartridge if it is damaged jPut your pump in STOP mode disconnect the infusion set, and take out and reinsert the battery, so that the self-test is started then put your pump back in RUN mode.Note If a Temporary Basal Rate, an Extended Bolus or a Multiwave Bolus is active at the same time, it is cancelled when your pump is put into STOP mode. A Warning W8: BOLUS CANCELLED or a Warning W6: TBR CANCELLED is displayed. Press f twice to conrm and turn off the alert. The alerts are recorded in the alarm history. See chapter 8 Warning W6: TBR CANCELLED and Warning W8: BOLUS CANCELLED. Make sure that the cancellation was deliberate, put your pump back in RUN mode and then program a new Temporary Basal Rate (and / or an Extended or Multiwave Bolus), if needed.
146c CAUTION Immediately inspect your pump if it is dropped. Do not use your Accu-Chek Spirit Combo insulin pump if chips, cracks or other damages are visible. Otherwise water, dust, insulin or other foreign substances may enter your pump and could result in a malfunction.If you have questions or are not sure whether your pump has been damaged, contact your local pump support (details on inside back cover). 7.3 Your insulin pump and waterc CAUTION Avoid contact with water. Check daily that your Accu-Chek Spirit Combo insulin pump is not chipped, cracked or damaged in any way, and that the battery cover and the adapter are correctly closed. If the pump is chipped or cracked, water, dust, insulin, or other substances may enter your pump and lead to malfunction. Before any contact with water, disconnect and take off your pump.Disconnect and remove your pump before taking a bath, or going into a whirlpool, shower, or swimming pool. Avoid exposing your pump to high humidity, such as in a sauna, as this could result in damage. To make it easy to remove your pump, use disconnectable Accu-Chek infusion sets.
14777.3.1 Accidental contact with waterYour Accu-Chek Spirit Combo insulin pump is IPX8 waterproof when leaving the factory site. However hair-line cracks could appear during use. Therefore we may only guarantee protection against brief accidental water contact such as:Rain jWater splashes while you are cycling, jogging or hiking jAccidental immersion in the sink, washbasin or bath jWhat to do after any water contactPut your pump into STOP mode, disconnect the pump from your body, and inspect it. Use a soft dry cloth to dry the outside of the pump, and check the battery compartment and the cartridge compartment for water. If the battery compartment or cartridge compartment are wet, turn your pump upside down to let the water run out and let it air dry. Do not use warm air such as a hair dryer to dry the pump, as this could damage the pump’s housing. Do not reinsert the battery or the cartridge until the compartments are completely dry. See section 7.5.1 Cleaning your pump.Other liquidsYou do not have to worry about contact between your pump and perspiration or saliva. You must however check your pump immediately after contact with other liquids or chemicals such as:Cleaning solutions jAlcohol jBeverages jOil or Fat jIn case of contact with these substances, clean your pump immediately. See section 7.5 .1 Cleaning your pump.c CAUTION Avoid any contact between your Accu-Chek Spirit Combo insulin pump, the infusion set, and the connecting parts of your insulin pump with health and beauty items (for example: antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or any other cosmetics). These substances could discolor your pump or fog the display.
1487.4 Repair of your pumpc CAUTION Do not perform any servicing or repair on your pump. Do not use any lubricants on the pump mechanism. If you have questions, contact your local pump support (details on inside back cover). If you have problems with your pump, contact your local pump support (details on inside back cover). Your local pump support can answer many questions and resolve many problems over the telephone. You may be requested to return your pump to Disetronic Medical Systems for repair. For example, you may need to return your pump if a Warning or Error could not be cleared by following the procedures described in chapter 8 Warnings and Errors. If you have to ship your pump, carefully pack the pump and the used cartridge, battery, battery cover, adapter, and infusion set to avoid damage during transportation. Place your pump back in the shipping case and put the case in a package that will not rip or tear. It is recommended to ship your pump using a company that tracks the shipment for you.When you return your pump, include the following: your name and address jyour daytime phone number jthe serial number of your pump jany RMA (Return Material Authorization) number received from jyour local pump support. By returning your pump to Disetronic Medical Systems, you authorize Disetronic Medical Systems to undertake any testing on your insulin pump that is needed for a proper inspection, and understand that your pump may not be returned to you. (For the address, see inside the back cover.)
14977.5 Maintaining your pump7.5.1 Cleaning your pumpThe best time to clean your pump is when you change the cartridge. Use a soft cloth to clean the outside of the pump. If necessary, use a damp clean cotton cloth with water or, even a 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 contact with water.c CAUTION Always remove the cartridge and adapter, and put your pump in STOP mode while cleaning. Avoid pressing the keys of your Accu-Chek Spirit Combo insulin pump during cleaning, as this may accidentally change your settings. Do not use alcohol, solvents, strong detergents, bleaching agents, scouring pads or sharp instruments for cleaning, as they may damage the pump.7.5.2 BatteriesIt is important to change your battery regularly and to keep spare batteries available. The life of any battery is affected by how you use your Accu-Chek Spirit Combo insulin pump, your personal settings, delivery rates, temperature, and other factors. For details about the battery lifetime see Appendix A for lifetime of battery. See section 1.4 Accessories and disposables or Appendix C for more information on recommended batteries. See section 2.2 Inserting the battery for instructions on how to change your battery.
1507.6 Storing your pumpc CAUTION When your pump will not be in use for a long period of time, it must be properly stored to prevent any subsequent malfunction.To store your pump, place it in STOP mode, then: Remove the battery to preserve the battery life jRemove the cartridge jInsert the battery cover jStore your pump in its packaging jStorage conditions Temperature 41 °F to 113 °F (+5 °C to +45 °C)Air humidity 5 to 85 % relative air humidity Barometric pressure 700 to 1060 mbar 7.7 Disposing of your pumpSince your Accu-Chek Spirit Combo insulin pump may come into contact with blood during use, it may carry a risk of infection. If you need to dispose of your Accu-Chek Spirit Combo insulin pump, return it to Disetronic Medical Systems (address inside the back cover) for professional disposal. Battery Correctly dispose of empty batteries, recycling them whenever possible. Cartridge, Infusion set, Adapter, and Accessories Dispose of these items in your normal household waste or, for the batteries, at the usual recycling point. Remember to dispose of the introducer needle safely (using the needle container). To prevent injury to others, replace the needle protective cap or insert the needle of the infusion set into a disposable object, or put it in a hard-shell container.
15188 Warnings and ErrorsA safety system monitors and controls the function of your Accu-Chek Spirit Combo insulin pump. This safety system performs more than 9 million safety checks every day. If it detects a change from the pump’s normal state, it will trigger a Warning or an Error message. Beeps, vibrations, and messages on the pump screen indicate the cause of a Warning or Error. Warnings and Errors are the only way you can be quickly notied of any changes in your pump.c CAUTION Check the pump display regularly during the day, and before you go to sleep, and especially if you might not be able to hear the beeps or feel the vibrations for any reason.Your pump signals Warnings and Errors using beeps and vibrations. You can turn off either the beeps or the vibrations, but for your safety you cannot turn off both at the same time for the initial alarm signal.If you do not conrm a Warning or Error within 60 seconds, it will be signalled again. Even when the beep is turned off or pro-grammed at lower than maximum volume, the beep volume will rise to the loudest volume level if not conrmed. Both the beep and vibration will then continue at this level until conrmed.Note j The volume of the STOP-Warning is separate from the programmed beep volume and cannot be changed. It always occurs at the maximum level.Keylock is unlocked by the system each time a Warning jor Error occurs.
1528.1 Conrming a Warning or ErrorWhen you conrm:W1: CARTRIDGE LOWE1: CARTRIDGE EMPTYW2: BATTERY LOWE2: BATTERY EMPTYW5: PUMP TIMER (“Backup” pumps only)E5: END OF OPERATION, the symbol for that Warning or Error stays in the RUN screen or STOP screen as a Reminder. Battery low symbolCartridge low symbolPump timer symbolKey lock symbolFor other Warnings or Errors, alarm information is cleared from the display but stays in the alarm history and the event memory.When a Warning or an Error occurs: Press jf to turn off the beeps and vibrations. The Warning or Error code stays on the display. As soon as you understand the reason for the Warning or Error, jconrm by pressing f again. Take appropriate action, as necessary. j If more than one Warning and /or Error occurs simultaneously, jpress f twice for each Warning or Error to conrm them and turn them off. After a Warning or Error, make sure that you switch your pump jback to RUN mode where appropriate.Note When you use your pump together with the Meter you can also snooze and conrm an incoming Warning or Error with the Meter. For further information see the Meter user information.
15388.2 List of Warningsw WARNING After a Warning occurs, your Accu-Chek Spirit Combo insulin pump may be in STOP mode and insulin delivery may be interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each Error code, or put your Accu-Chek Spirit Combo insulin pump in RUN mode to continue the insulin delivery.Warning W1: CARTRIDGE LOW The contents of the insulin cartridge have dropped to 20 units of insulin. Be prepared to replace the cartridge as soon as possible. The “cartridge low” symbol appears in the RUN or STOP screen as a Reminder until you change the cartridge. Press jf twice to snooze and to conrm the Warning. Change the cartridge before it is empty. If necessary, put your pump in RUN mode. jSee section 3.5 Changing the cartridge and infusion set.
154Warning W2: BATTERY LOWThe battery power is low. Be prepared for a battery change as soon as possible. The battery low symbol appears in the RUN or STOP screen as a Reminder until you change the battery. Press jf twice to snooze and to conrm the Warning. Replace the battery as soon as possible. Failure to change the jbattery within a few hours of receiving the Warning could result in additional Error messages. If necessary, put your pump in RUN mode. jSee section 1.4 Accessories and disposables on recommended batteries. See section 2.2 Inserting the battery for instructions on how to change the battery. Warning W3: REVIEW TIME The pump has been without power for more than one hour. The pump settings and history data are saved in memory regardless of power loss. However, it may be necessary to set the time and date again. Press jf twice to snooze and to conrm the Warning. Review the time and date and correct them, if they are wrong. jIf necessary, put your pump in RUN mode. jSee section 2.4 Setting the time and date.
1558Warning W4: CALL FOR UPDATEThe pump is nearing six years of life. You may want to consider updating to a new product. Contact your local pump support (see inside back cover).Press jf twice to snooze and to conrm the Warning. Put your pump in RUN mode if necessary. jWarning W5: PUMP TIMER (“Backup” pumps only)Your pump’s operating time will expire soon. When the Warning W5: PUMP TIMER occurs, the pump will display the symbol to remind you to check the timer. Press jf twice to snooze and to conrm the Warning. Put your pump in RUN mode. jGo to the MY DATA menu on your pump. j
156Move to the PUMP TIMER screen. The days until the pump jtimer expires are shown. When the PUMP TIMER reaches zero, the pump will change to STOP mode and will no longer operate. An Error, E5: END OF OPERATION, will appear on the display. Contact your local pump support (details on inside back cover) to discuss the options for further use of your Accu-Chek Spirit Combo insulin pump. Note The Warning W5: PUMP TIMER and the Error E5: END OF OPERATION are based on running time (the total time the pump is in RUN mode), and not on calendar years. See section 5.4.5 Viewing the time remaining.Warning W6: TBR CANCELLED (Temporary Basal Rate Cancelled) A temporary increase or decrease in the basal rate has been cancelled. Press jf twice snooze and to conrm the Warning. If necessary, put your pump in RUN mode. jMake sure that the cancellation was intended and then jprogram a new Temporary Basal Rate if necessary.
1578Warning W7: TBR OVER (Temporary Basal Rate Over) A Temporary Basal Rate has ended. The original basal rate (100 %) will resume automatically once the Warning has occurred. Press jf twice to snooze and conrm the Warning. Decide whether a further jTemporary Basal Rate change is required. If necessary, program a new Temporary Basal Rate.Warning W8: BOLUS CANCELLED A bolus was cancelled during the start delay or after delivery began. Press jf twice to snooze and to conrm the Warning. If necessary, put your pump in RUN mode. jMake sure that the cancellation was intended and then jprogram a new bolus if needed. Note The actual bolus amount that was delivered before the cancellation can be reviewed in the bolus history. See section 5.4.1 Viewing your bolus history.
158Warning W9: LOANTIME WARNING (loan pumps only)The pump is coming to the end of its loan period. In the MY DATA menu, check the remaining loan time in the PUMP TIMER menu. Make sure that you arrange for the replacement of the pump within the scheduled loan time.Press jf twice to snooze and to conrm the Warning. Put your pump in RUN mode if necessary. jGo to the MY DATA menu on your pump. jMove to the PUMP TIMER screen. The days until the loantime jexpires are shown. Warning W10: BLUETOOTH FAULT You need to re-do the pairing procedure for the Accu-Chek Spirit Combo insulin pump and Meter. See section 6.3 Pairing your pump with the Meter. Press f twice to snooze and to conrm the Warning. Put your pump in RUN mode if necessary. j
15988.3 List of Errorsw WARNING After the occurrence of an Error, your Accu-Chek Spirit Combo insulin pump is in STOP mode and insulin delivery is inter-rupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each Error.Error E1: CARTRIDGE EMPTY The insulin cartridge is empty. You must change it immediately. Press jf twice to snooze and to conrm the Error. Disconnect or remove the infusion set from the infusion site. jChange the cartridge and prime the infusion set. jReconnect the infusion set at your infusion site. jPut your pump in RUN mode. jSee section 3.5 Changing the cartridge and infusion set.Error E2: BATTERY EMPTY The battery is empty. You must replace it immediately.w WARNING After inserting a new battery, always check that the time and date of your Accu-Chek Spirit Combo insulin pump are set correctly. Incorrect programming of the time and /or date may cause incorrect insulin delivery. If you, your doctor or healthcare team store and analyze your therapy data electronically and the time and date of the devices used are not set identically, the resulting data might not be meaningful.
160Press jf twice to snooze and to conrm the Error. Replace the battery. jPut your pump in RUN mode. jNote Your pump stores the settings you saved before the battery power ran out. If your pump is without power for more than one hour, check that the time and date are still correct. See section 1.4 Accessories and disposables on recom-mended batteries. See section 2.2 Inserting the battery for instructions on how to change your battery.Error E3: AUTOMATIC OFF Automatic Off is a safety feature that stops insulin delivery and triggers an Error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. Press jf twice to snooze and to conrm the Error. Put your pump in RUN mode. j
1618Error E4: OCCLUSION w WARNING If the Error E4: OCCLUSION occurs, immediately check your blood glucose level, and then check again about two hours later, as insulin delivery has been interrupted. If your blood glucose level is high, take appropriate action according to your doctor’s or healthcare team’s instructions.Insulin was not delivered. This may be due to: a blocked infusion set ja damaged cartridge ja dirty or damaged piston rod jIf an Error E4: OCCLUSION (blockage) occurs, follow the steps listed below:Press jf twice to turn off and to conrm the Error. Disconnect or remove the infusion set from your infusion site. jChange the infusion set and prime it, as explained in chapter j2. Reconnect the infusion set at your infusion site. jPut your pump in RUN mode. j
162In rare cases, the cartridge itself can be the cause of the occlusion. If an Error E4: OCCLUSION occurs again, you must change the cartridge. Follow the steps listed below: Press jf twice to turn off and to conrm the Error. Disconnect or remove the infusion set from your infusion site. jChange the cartridge and prime the infusion set, as explained jin chapter 2.Reconnect or insert a new infusion set at your infusion site. jPut your pump in RUN mode. jIf the Error E4: OCCLUSION occurs again, prime your pump without a cartridge. Follow the steps listed below:Press jf twice to turn off and to conrm the Error. Disconnect or remove the infusion set from your infusion site. jRemove the cartridge, adapter and infusion set from your pump. jCarry out the jINFUSION SET PRIMING function (See section 2.8 Priming the infusion set) without the cartridge, adapter, and infusion set inserted. Insert a new cartridge with the adapter and infusion set jconnected. Prime the infusion set. jReconnect the or insert a new infusion set at your infusion jsite. Put your pump in RUN mode. jIf the Error E4: OCCLUSION continues to occur, use the alternative therapy plan provided by your doctor or healthcare team. Contact your local pump support (details on inside back cover) for more assistance.
1638Error E5: END OF OPERATION (“Backup” pumps only)Your pump timer of your Backup pump has reached zero. The pump changes to STOP mode and will no longer operate. An Error E5: END OF OPERATION appears on the display. Before this Error occurs, a Warning W5: PUMP TIMER will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team.Press jf twice to snooze and to conrm the Error. Contact your local pump support (see inside back cover) jto discuss the options for further use of the Accu-Chek Spirit Combo insulin pump.Note The Warning W5: PUMP TIMER and the Error E5: END OF OPERATION are based on running time (the total time the pump is in RUN mode) and not on calendar years.
164Error E6: MECHANICAL ERROR A mechanical Error has been discovered during a routine automatic system check and insulin delivery has stopped. Press jf twice to snooze and to conrm the Error. Remove or disconnect the infusion set from your infusion site. jRemove the cartridge, adapter, infusion set, and battery from jyour pump. Insert a new battery.Install a new cartridge and infusion set. It is essential that you jrewind the piston rod. (See section 2.7 Inserting the cartridge). Prime the infusion set (See section 2.8 Priming the infusion set).Reconnect the infusion set at your infusion site. jPut your pump in RUN mode. jIf the Error E6: MECHANICAL ERROR occurs again, use the alternative therapy plan provided by your doctor or healthcare team. Contact your local pump support (details on inside back cover) for more assistance. Error E7: ELECTRONIC ERROR An electronic Error has been discovered during a routine automatic system check and insulin delivery has stopped. Note You cannot turn off and conrm an Error E7: ELECTRONIC ERROR by pressing f. You must remove the battery instead.
1658Remove or disconnect the infusion set from your infusion site. j Replace the battery in the pump (See section j2.2 Inserting the battery). Prime the infusion set. jReconnect the infusion set at your infusion site. jPut your pump in RUN mode. jAfter an Error E7: ELECTRONIC ERROR always check your settings like e.g. basal rate prole, time and date. If the Error E7: ELECTRONIC ERROR occurs again, contact your local pump support (details on inside back cover) for assistance. Use the alternative therapy plan provided by your doctor or healthcare team.Error E8: POWER INTERRUPT A power interrupt Error occurs when you insert a new battery without rst placing the pump in STOP mode. See section 2.2 Inserting the battery for instructions on how to change the battery. 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. Press jf twice to snooze and to conrm the Error. Your pump goes into STOP mode. jCheck the time and date and correct them if they are wrong. jSee section 2.4 Setting the time and date. Put your pump in RUN mode. Program a new bolus and /or jTemporary Basal Rate if necessary. See chapter 4 Boluses and Temporary Basal Rates.If an Error E8: POWER INTERRUPT occurs during programming, check your settings.
166Error E9: END OF OPERATION (loan pumps only)Your pump timer has reached zero. The pump changes to STOP mode and will no longer operate. An Error E9: END OF OPERA-TION appears on the display. Before this Error occurs, a Warning W9: LOANTIME WARNING will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team.Press jf twice to snooze and to conrm the Error. Contact your local pump support (details on inside back cover) jto discuss the options for further use of the Accu-Chek Spirit Combo insulin pump.Note The Warning W9: LOANTIME WARNING and the Error E9: END OF OPERATION are based on running time (the total time the pump is in RUN mode) and not on calendar years. Error E10: CARTRIDGE ERRORThe CARTRIDGE CHANGE function was not correctly performed.Press jf twice to snooze and to conrm the Error. Remove or disconnect the infusion set from your infusion site. jRemove the cartridge. jReinsert the cartridge. (See section j2.7 Inserting the cartridge)
1678Prime the infusion set. jReconnect the infusion set at your infusion site. jPut your pump into RUN mode. jIf the Error E10: CARTRIDGE ERROR occurs during the jrewinding of the piston rod, insert a new battery in the pump and repeat the procedure. Error E11: SET NOT PRIMED The cartridge has been changed but the infusion set has not been primed. The Error will be displayed when you try to put your pump in RUN mode.Press jf twice to snooze and to conrm the Error. Remove or disconnect the infusion set from your infusion site. jPrime the infusion set. (See section j2.8 Priming the infusion set)Reconnect the infusion set at your infusion site. jPut your pump in RUN mode. jSee sections 3.5 Changing the cartridge and infusion set and 2.8 Priming the infusion set. w WARNING Never prime an infusion set that is connected to your body. You risk uncontrolled insulin delivery into your body. Always follow the instructions provided with your infusion set.
168Error E12: DATA INTERRUPTED c CAUTION If infrared data transfer between your pump and a compatible device is disrupted in any way, the conguration may be incomplete and the Error E12: DATA INTERRUPTED will occur. The data transfer must be successfully completed before you can put your Accu-Chek Spirit Combo insulin pump into RUN mode.Data transfer between your pump and the computer was interrupted before it was completed.Press jf twice to snooze and to conrm the Error. Restart the data transfer. jBefore you can put your pump in RUN mode, the data transfer must have been successfully performed.See section 5.5 Transferring your data to a computer.
1698Error E13: LANGUAGE ERROR The language setting needs to be checked.Press jf twice to snooze and to conrm the Error. Follow the steps in section j5.6 Pump settings to change the language. Put your pump in RUN mode. j
1708.4 List of RemindersReminder R1: Reminder A Reminder has been programmed on the pump. Press jf twice to snooze and to conrm the Reminder. If necessary, put your pump in RUN mode. jNote If you have set the Reminder occurrence to EVERY DAY, the same Reminder occurs every 24 hours. Turn the Reminder function OFF if you do not want the alarm to go off again at that same time every day. See section 5.9 Setting a Reminder.
17199 TroubleshootingThis chapter describes problems that may occur when using your Accu-Chek Spirit Combo insulin pump. Any problems that generate a Warning or Error are described in chapter 8.Note The solutions provided in this chapter will normally enable you to resolve the problem and continue with your pump therapy. However, if the recommended action does not resolve the problem, or if you have any concerns, do not hesitate to contact your local pump support (see inside back cover) or your doctor or healthcare team.Note Troubleshooting information relating to the Bluetooth ® connection between the Meter and the Accu-Chek Spirit Combo insulin pump is included in chapter 6 Using the Accu-Chek Spirit Combo insulin pump with the Meter. Also refer to the documentation (Owner’s Booklet) that comes with the Meter.Although your pump has an internal security check system, it cannot for example detect if your infusion set is leaking or if the insulin you are using has lost its effectiveness. These problems can result in a rapid rise in your blood glucose level. Therefore, it is essential to check your pump and blood glucose level during the day.
1729.1 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.Problem Recommended ActionIndividual characters, numbers, or symbols on the display are shown incompletely or not at all.Contact your local pump support (details on inside back cover).Your Accu-Chek Spirit Combo insulin pump does not beep or vibrate.Check that the beep volume and alarm signals are turned on. Check the battery and change it if necessary. If the pump still does not beep or vibrate, contact your local pump support (details on inside back cover).The self-test is not completed correctly (after an Error E7: ELECTRONIC ERROR).Remove the battery, wait a few seconds, and insert it again. If the self-test is still not completed correctly, contact your local pump support (details on inside back cover).Insulin delivery is incorrect due to inaccurate time setting. If the time setting is inaccurate, the correct hourly basal rate cannot be delivered. Check and reset the time if necessary. Perform the same check whenever you change the battery.Insulin delivery is incorrect due to incorrect basal rate programming.Review any changes that you have made to your basal rate program-ming, to ensure that you are using the correct basal rate prole.
1739Problem Recommended ActionThere are air bubbles in the cartridge and /or infusion set. Check your blood glucose level.In the cartridge: Disconnect the infusion set from the headset and re-prime the infusion set. If the air bubbles remain, replace the cartridge. Always ll the cartridge with insulin that is at room tempera-ture.In the infusion set: Disconnect from the headset and prime your infusion set. Reconnect the headset and ensure that all connections are tight and secure.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 are tight. Inspect the connections for leaking insulin. Change your infusion set and infusion site.
174Problem Recommended ActionThere is a leak in the system. Check your blood glucose level. Check for leaking insulin at all the connection points and on the skin. Change the infusion set, the infusion site, the cartridge and the adapter. There is an occlusion (blockage) in the system. Check your blood glucose level. Follow the instructions in chapter 8 Error E4: OCCLUSION.Priming was not completed (E11 or air bubbles in infusion set).Re-prime the infusion set. Always prime until a bubble-free insulin ow emerges from the tip of the needle. Ensure that the tubing is free of air.
175AAppendix A: Technical DataGeneral Technical DataMaximum dimensions (without adapter)Approx. 82.5 × 56 × 21 mm (3.2 × 2.2 × 0.8 inches)Weight an empty insulin pump: approx. 80 g (2.8 ounces) jinsulin pump inclusive battery, full plastic cartridge and infusion set: japprox. 110 g (3.9 ounces)Pump casing Shock- and scratch-resistant plastic, resistant to pharmaceuticals, all edges roundedTemperature ranges* During 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)Air humidity During operation: 20 to 90 % relative humidityStorage in its shipping case: 5 to 85 % relative humidity During Transport: 5 to 95 % relative humidity
176General Technical DataBarometric pressure During operation or storage in its shipping case: 70 to 106 kPA (700 to 1060 mbar) (do not exceed 3000 meters [10 000 feet] above sea level)During Transport: 50 to 106 kPA (500 to 1060 mbar)Power supply One 1.5 volt AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 volt rechargeable NiMH AA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Use only a battery charger ofcially recommended by the battery manufacturer.Lifetime of battery If used in a typical usage pattern (50 U / day using U100 insulin; operating temperature 23 °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 ® onData storage time The time and date are safely stored in the memory for about 1 hour after the battery has been removed. Other insulin pump settings (the hourly basal rates, remaining cartridge content, 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.
177AGeneral Technical DataDelivery 1 / 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.Bolus The max. bolus amount per delivery is 50 insulin units. The bolus amount for the Quick Bolus 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 xed increments of 0.1 units. The duration of the Extended Bolus and the Multiwave Bolus is adjustable in intervals of 15 minutes (15 minutes up to 24 hours).Temporary Basal Rate Adjustable in 10 % increments, 0 – 90 % for decreases, 110 – 250 % for increases. The duration is adjustable in 15 minute intervals, up to a maximum of 24 hours. The last programmed duration is given by default for the next Temporary Basal Rate change programmed.
178General Technical DataMaximum time for an Error E4: OCCLUSION** Plastic cartridges:at medium basal rate 1.0 U / h: ≤ 2 h jat minimum basal rate 0.05 U / h: ≤ 24 h jMaximum volume before Error E4: OCCLUSION**Plastic cartridges: ≤ 1.5 U.Maximum pressure 400 kPa (4.0 bar), for plastic and infusion sets.Flow (delivery rate) During infusion set priming and bolus 0.2 U / sec.Maximum quantity delivered at a single fault condition≤ 1.0 UCartridge Accu-Chek Spirit 3.15 ml Cartridge System and Accu-Chek 3.15 ml Plastic Cartridge with a luer connection.
179AGeneral Technical DataInfusion sets Accu-Chek infusion sets with a luer-lock connector.Accu-Chek Infusion sets are PCV and latex free.Data transfer Infrared interfaceSafety system Alert system, beeps, information on the display, vibrations, dual microprocessors. Your insulin pump is controlled by two microprocessors. The safety concept is based on one processor (supervisor processor) supervising the other (main processor). Whenever a defect or fault occurs in the main processor, it is identied by the supervisor processor. The motor is immediately switched off and an Error E7: ELECTRONIC ERROR occurs. Conversely, the main processor can also determine at any time whether the supervisor is working correctly. The motor also constitutes an important safety component, as the combination of the main and supervisor processor and brushless motor provides the best possible reliability and accuracy in insulin delivery. IPX8 Protected against the effects of temporary immersion in water under standardized condi-tions (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.
180Technical standardsTable 201: Electromagnetic emissionGuidance and manufacturer’s declaration – electromagnetic emissions The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specied below. The customer or the user of the Accu-Chek Spirit Combo should ensure that it is used in such an environment.Emission test Compliance Electromagnetic environment – guidanceRF emissionsCISPR 11Group 2 The Accu-Chek Spirit Combo must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.RF emissionsCISPR 11Class B The Accu-Chek Spirit Combo is suitable for use in all establish-ments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissionsIEC 61000-3-2Not applicable –Voltage uctuations / icker emissionsIEC 61000-3-3Not applicable –
181ATable 202: Electrostatic discharge (ESD) and power frequency magnetic elds (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specied below. The customer or the user of Accu-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 oors are covered with synthetic material, the relative humidity should be at least 30 %.Electrical fasttransient / burstIEC 61000-4-4± 2 kV for power supply linesNot applicableSurgeIEC 61000-4-5± 1 kV line to line± 2 kV line to earthNot applicable
182Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidanceVoltage dips, short interruptions and voltage variations on power supply linesIEC 61000-4-11< 5 % UT (0,5 cycle)40 % UT (5 cycles)70 % UT (25 cycles)< 5 % UT for 5sNot applicableNote UT 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 eldIEC 61000-4-8400 A / m 400 A / m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment.* Test levels acc. to IEC / EN 60601-2-24
183ATable 203: Immunity electromagnetic elds (life-supporting devices)Guidance and manufacturer’s declaration – electromagnetic immunityThe Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specied below. The customer or the user of the Accu-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, including cables, 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 61000-4-63 Vrms150 kHz to 80 MHzV1 = 10 Vrms150 kHz to 80 MHz d = 1.2 P 150 kHz to 80 MHzRadiated RFIEC 61000-4-310 V / m80 MHz to 800 MHzE1 = 10 V / m80 MHz to 800 MHz d = 1.2 P 80 MHz to 800 MHzRadiated RFIEC 61000-4-310 V / m800 MHz to 2,5 GHzd) 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 P 2.3 GHz to 2.5 GHzdb = 2.3 P 800 MHz to 2.3 GHz and 2.5 GHz to 2.7 GHz
184Guidance 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 the recommended separation distance in metres (m).Field strengths from xed RF transmitters. as determined by an electromagnetic site survey, a) should be less than the compliance level in each frequency range. b) Interference may occur in the vicinity of equipment marked with the following symbol: Note At 80 MHz and 800 MHz, the higher frequency range applies.Note These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.a ) Field strengths from xed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Accu-Chek Spirit Combo is used exceeds the applicable RF compliance level above, the Accu-Chek Spirit Combo or the device, which contains it should be observed to verify normal operation. If abnormal performance 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, eld strengths should be less than 10 V / m.c ) Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.d ) Exclusion band for Bluetooth ® ISM 2.4 GHz communication channele ) Compliance band for the system equipment
185ATable 205: Recommended separation distances (life-supporting devices)Recommended separation distances between portable and mobile RF communications equipment and the Accu-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 minimum distance between portable and mobile RF communications equipment (transmitters) and the Accu-Chek Spirit Combo as recom-mended below, according to the maximum output power of the communication equipment. Rated maximum output power of transmitter (W)Separation distance according to frequency of transmitter (m)150 kHz to 80 MHzd = 1.2 P 80 MHz to 800 MHzd = 1.2 P800 MHz to 2.3 GHzdb = 2.3 P 2.3 GHz to 2.5 GHz da = 11.7 P 0.01 12 cm 12 cm 2 3 cm 118 cm 0.1 38 cm 38 cm 73 cm 373 cm 1 1.2 m 1.2 m 2 . 3 m 11.8 m 10 3.8 m 3.8 m 7. 3 m 3 7. 3 m100 12 m 12 m 2 3 m 118 mFor transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable 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.
186Note At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note These guidelines may not apply in all situations. Electro-magnetic propagation is affected by absorption and reection from structures, objects and people.Note An additional factor of 10 / 3 is used in calculating the recommended separation distance to decrease the likelihood that mobile / portable communications equip-ment could cause interference if it is inadvertenly brought into the vicinity of the user.
187AAccuracy of ow rate for both Accu-Chek 3.15 ml Plastic Cartridges and Accu-Chek Spirit 3.15 ml Cartridge SystemTrumpet curve plotted from data after the end of the stabilization periodThe trumpet curve shows the accuracy of the delivery rate in relation to the observation period.percentage Error of ow (%)200101520060 120 180 300 660 780 960240 360 840 600 840105420 480 720 9005158 173 17 2 58 2 180 180 220 823 811 970 811 791 02A= 1 38observation window duration (min) minimum measured variation maximum measured variation overall percentage ErrorThe maximum deviation of the delivered amount (overall mean percentage ow Error) for U100 insulin is ≤ ± 5 %*. * The measurements were made at a medium basal rate of 1.0 U / h according to IEC 60601-2-24:1998 with an Accu-Chek Ultraex infusion set PC 16 / 110 at room temperature.
188Start-up graph over the stabilization periodThe start-up graph shows changes in the ow rate over the stabilization time.ow rate (ml / h)0 0120 0060 0040 0020 0000 120 240 360 600 1080 1200 1440480 720 840 960 13200 0100 008time (min) real ow target ow0.01 ml is equivalent to 1IU (U100 insulin) Inuence of height on delivery accuracyThe maximum deviation of the delivered amount (overall mean percentage ow Error) for U100 insulin is ≤ ± 10 %* where your Accu-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 / h according to IEC 60601-2-24:1998 with an Accu-Chek Ultraex infusion set PC 16 / 110 at room temperature.** The measurements were made according to IEC 60601-2-24:1998 with a Accu-Chek Ultraex infusion set PC 16 / 110 at room temperature.
189BAppendix B: Conguration parametersTypical range available on the pump and standard parameter settings*Maximum parameter range adjustable with the appropriate Accu-Chek PC Software Basal rate Hourly basal rate + max. TBR (hourly basal rate combined with temporary basal rate, max. increase)62.5 U / h max. amount: 0 – 250.0 U / hHourly basal rates increment 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) 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 increments0 – 250 %10 %max. 24 h15 min0 – 500 %10 %15 min – 50 h15 min, 30 min, 1 hBasal rate proles availableBasal rate lock5off1 – 5on or off* Note: These factory settings may vary in some countries and depend on the changes you, your doctor or healthcare team make using your insulin pump or pump programming software for healthcare professionals.
190Typical range available on the pump and standard parameter settings*Maximum parameter range adjustable with the appropriate Accu-Chek PC Software BolusBolus amount per bolus delivery 2 5 . 0 U max. amount: 0 – 50.0 Ubolus amount increments for Quick Bolus bolus 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 2 5 . 0 U max. amount: 0 – 50.0 UDisplay orientation standard or invertedDisplay contrast 7 stepsUser menus 3 (STANDARD, ADVANCED or CUSTOM)Volumes (for beeps) off, 4 stepsAlarm signals turned on beeps, vibrations or both
191BTypical range available on the pump and standard parameter settings*Maximum parameter range adjustable with the appropriate Accu-Chek PC Software Battery type AA (LR6) ALKALINE, AA (FR6) LITHIUM or AA (HR6) NiMH rechargeable batteryKeylock turned on or offAutomatic off turned on (1 – 24 h) or off (0 h)Reminder turned on or offwhen on: once or every day’s occurrenceTime format European (24 h) orAmerican (12 h, am / pm)Date format European (dd.mm.yy) orAmerican (mm / dd / yy)Bluetooth on or off* Note: These factory settings may vary in some countries and depend on the changes you, your doctor or healthcare team make using your insulin pump or pump programming software for healthcare professionals.
192CartridgesName CommentsAccu-Chek Spirit 3.15 ml Cartridge SystemAccu-Chek 3.15 ml Plastic CartridgePlastic cartridges are single-use items only. Do not re-use cart ridges. Refer to the instructions for use of the insulin you are using for information on the acceptable temperature range for storage and handling.Accu-Chek infusion setsName CommentsAccu-Chek TenderAccu-Chek UltraexAccu-Chek Rapid-DAll Accu-Chek infusion sets are available in various tubing and needle lengths. All Accu-Chek branded Infusion Sets are compatible with the Accu-Chek Spirit Combo insulin pump. Discuss with your doctor and /or healthcare team to nd the infusion set that ts you best.For recommendations on how long you may use the same infusion set see the information material provided with this product.Appendix C: Sterile products and accessories
193CAccessoriesName CommentsAdapterBattery CoverAdapter and Battery Cover are part of the Accu-Chek Spirit Combo Service Pack and Accu-Chek Spirit Combo Service Pack small. Replace your adapter every two months.Batteries One 1.5 volt AA (LR6) Alkaline or AA (FR6)Lithium battery with a minimum capacity of 2500 mAh.For battery lifetime see p. 176 Lifetime of batteryRechargeable BatteriesOne 1.2 volt AA (HR6) NiMH rechergeable battery with a minimum capacity of 2500 mAh.For battery lifetime see p. 176 Lifetime of batteryRechargeable batteries are not provided by Disetronic Medical Systems. Use only a battery charger ofcially recommended by the battery manufacturer.Battery Cover Replace your battery cover every two months.Name CommentsCarrying Systems All Accu-Chek Spirit Combo and Accu-Chek Spirit Carrying systems are compatible with the Accu-Chek Spirit Combo insulin pump. Disetronic Medical Systems offers a wide range of carrying system solutions to best t your lifestyle.Accu-Chek PC Conguration SoftwareCheck with your local pump support for the availability of appropriate pump programming software.Accu-Chek Spirit Combo Quick Reference GuideThis is a convenient pocket size reference that you may take with you to assist with your insulin pump questions.
194Appendix D: AbbreviationsAbbreviation Meaningapprox. ApproximatelyBR Basal RateBRP Basal rate prolehHour (s)IEC International Electrotechnical Commissionincl. Inclusive or includingIR InfraredI.U., U International Units in context with biological effectiveness of certain insulin amountkPa Kilo pascalsLCD Liquid Crystal DisplayLED Light Emitting Diode for infrared communi-cation with e.g. a PCAbbreviation MeaningNiMH Nickel Metal Hydrid (used with rechargeable batteries)rel. Relativesec. SecondsTBR Temporary Basal RateUSee I.U.U / h Amount of International Units of insulin delivered per hourU100 This is the insulin concentration. Each milliliter of liquid contains 100 International Units of insulindd.mm.yy European date format: day.month.yearmm.dd.yy American date format:month.day.year
195EAppendix E: Beeps and melodiesAcoustic SignalsAll of the functions of the Accu-Chek Spirit Combo insulin pump are supported by acoustic signals. The acoustic signals are beeps.Sound FunctionDuration 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 soundSound FunctionDOWN 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 sound
196Sound FunctionBASE 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 soundSound Function + CARTRIDGE CONTENT <= 20 UFrequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 %Duration: f1 short sound, f2 short sound, long pause, f3 medium sound, short pause, f3 medium sound, short pause, f3 medium sound + 20 U < CARTRIDGE CONTENT <= 50 UFrequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 %Duration: f1 short sound, f2 short sound, long pause, f3 medium sound, short pause, f3 medium sound
197ESound Function + 50 U < CARTRIDGE CONTENT <= 100 UFrequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 %Duration: f1 short sound, f2 short sound, long pause, f3 medium sound + 100 U < CARTRIDGE CONTENTFrequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 %Duration: f1 short sound, f2 short sound, long pause, f3 long soundSYSTEM TEST SUCCESSFULFrequency: 1043 Hz ±5 %, 1314 Hz ±5 %, 1563 Hz ±5 %, 2090 Hz ±5 %Duration: 4 x long soundSound FunctionCOPY BASAL RATEFrequency: 2486 Hz ±5 %, 3131 Hz ±5 %, 2486 Hz ±5 %Duration: 3 x short soundTemporary Basal Rate ACTIVEFrequency: 2789 Hz ±5 %Duration: Short sound, short pause, short soundSTOP WARNINGFrequency: 2789 Hz ±5 %Duration: Long sound, short pause, long sound
198Sound FunctionReminder (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 %Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium soundRepeating Interval: 3000.0 ms ±20 %WARNING (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 %Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound, short pause, f2 medium soundRepeating Interval: 3000.0 ms ±20 %Sound FunctionERROR (REPEATING SEQUENCE)Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 %Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound, short pause, f2 medium sound, short pause, f2 medium soundRepeating Interval: 3000.0 ms ±20 %UPPER LIMIT REACHED Frequency: 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 sound
199ESound FunctionCONFIRMATION KEY PRESSEDFrequency: 2789 Hz ±5 %Duration: Short sound + CHANGED TO BASE STATE RUN BY CHECK KEY (KEYS UNLOCKED)Sequence: A12, long pause, A14 + CHANGED TO BASE STATE RUN BY CHECK KEY (KEYS LOCKED)Sequence: A12, long pause, A15 + CHANGED TO BASE STATE STOP BY CHECK KEY (KEYS UNLOCKED)Sequence: A12, long pause, A16 + CHANGED TO BASE STATE STOP BY CHECK KEY (KEYS LOCKED)Sequence: A12, long pause, A17 + CHANGED TO BASE STATE STOP BY CANCELLATION OF FUNCTIONSequence: A13, long pause, A16Sound FunctionINITIAL POINT (SUBMENU, VALUE)Frequency: 2820 Hz ±5 %Duration: Short sound, short pause, short soundSUPERVISOR SEQUENCE (GENERATED BY SUPERVISOR)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 %
200Tactile SignalsDedicated functions of the Accu-Chek Spirit Combo insulin pump are supported by tactile signals additionally. The tactile signals are vibrations which are generated by a vibra motor.Signal FunctionSHORT VIBRATIONDuration short vibration = 109.375 ms ±5 %MEDIUM VIBRATIONDuration medium vibration = 203.125 ms ±5 %LONG VIBRATIONDuration long vibration = 281.25 ms ±5 %Signal FunctionWARNING 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 %)
201FDisplay SymbolsIcon MeaningBasal Lock OFFBasal Lock ONBasal RateBasal Rate TotalBattery EmptyBattery LowBeep VolumeBluetooth ® OFFIcon MeaningBluetooth ® ONBluetooth ® SettingsBluetooth ® in Remote control modeBeep TestCartridge EmptyCartridge FullCartridge LowOKAppendix F: Symbols
202Icon MeaningClockData Transfer menuData Transfer (to start screen)Data Transfer runningDateDate Format EUDate Format USDisplay contrastExtended BolusKey Lock OFFIcon MeaningKey Lock ONPump timer (Call for update)Menu SettingsMultiwave BolusMultiwave Bolus ImmediateMy DataPairing FailedPairing SuccessfulPrimingProgress Bar
203FIcon MeaningPump SettingsReminderReminder EverydayReminder OFFReminder SettingsReminder SingleScreen OrientationBeepBeep and VibrationStandard BolusIcon MeaningStopTotalTemporary Basal RateTherapy SettingsTime and Date SettingsUnitsUnits per hourVibrationsErrorWarning
204General SymbolsIcon MeaningCaution. Please refer to safety-related notes in the manual accompanying this device.Consult instructions for useSterilized using ethylene oxideSterilized using radiationSterilized using antisepticsYear of manufactureLot numberIcon MeaningExpiry dateCatalogue numberSerial numberAdmissible temperature range during operationStore atAdmissible humidity rangeAdmissible air pressure range
205FIcon MeaningFragile – handle with careProtect against moistureProtect from heat and sunlightFor single use onlyDoes not contain pyrogenDoes not contain PVCRecyclingDo not throw awayIcon MeaningDo not use if the package is damagedFlammableBluetooth ® wireless technologyElectronic device of type BF according the standard IEC 60601-1. Protection against electrical shock.IPX8Symbol for protection against the effect of temporary immersion of water (up to 60 minutes and 2.5 meters [8 feet]), according to IEC 60529.Marking of conformity according to the European Medical Device Directive MDD 93 / 42 / EEC with the number of the notied body. Includes also RTTE DIRECTIVE 1999 / 5 / EC.
206Appendix G: WarrantyLimited Four-Year WarrantyDisetronic Medical Systems Inc. (“Disetronic”) warrants the ACCU-CHEK® Spirit Combo insulin pump (“insulin pump”) against defects in materials and workmanship for a period of four (4) years from the date of purchase. Proof of purchase date may be required. This warranty does not include supplies and accessories, including but not limited to, cartridges, batteries, or infusion sets.During the warranty period, Disetronic will repair or replace, in its sole discretion, any insulin pump that does not work properly because of a defect in materials or workmanship. The purchaser’s sole and exclusive remedy with respect to the insulin pump shall be repair or replacement. This warranty applies only to new devices. In the event an insulin pump is repaired or replaced, the warranty period will not be extended.Icon MeaningFCC IDThe FCC ID (Federal Communica-tions Commission Identication) indicates that the radio frequency equipment has passed the equipment authorization process for the United States of America.IC IDThe IC ID (Industry Canada Identication) indicates that the radio frequency equipment has passed the equipment authoriza-tion process for Canada.Federal law (USA) restricts this device to sale by or on the order of a physician.ManufacturerNon-ionizing radiationRecommended battery
207GThis warranty is valid only if the insulin pump is used in accord-ance with the user instructions. This warranty will not apply:If damage results from changes or modications made to the 1. insulin pump by the user or third persons after the date of manufacture;If damage results from service or repairs performed by any 2. person or entity other than Disetronic.If damage results from a force majeure or other event beyond 3. the control of Disetronic; orIf damage results from negligence or improper use, including 4. but not limited to improper storage, physical abuse such as dropping, or otherwise.This warranty shall be personal to the original purchaser. Any sale, rental, or other transfer or use of the insulin pump covered by this warranty to or by a user other than the original purchaser shall cause this warranty to immediately terminate.THIS WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL DISETRONIC OR ITS SUPPLIERS OR DISTRIBUTORS BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE INSULIN PUMP. No warranty of merchantability or tness for a particular purpose, if any is implied from the sale of the insulin pump, shall exist for a longer duration than four years from the date of purchase.Some jurisdictions do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specic legal rights, which may vary by jurisdiction.
208
209 GlossaryAccu-Chek Aviva Combo Meter This is an “intelligent” diabetes management device that enables you to measure your blood glucose level, manage your blood glucose data, and get bolus advice. It also enables remote control of your Accu-Chek Spirit Combo insulin pump, using Bluetooth ® wireless technology.AdapterThe adapter connects the cartridge and infusion set. It has two seals and forms an efcient seal for the cartridge compartment of your Accu-Chek Spirit Combo insulin pump. The two small vents on the adapter allow the equalization of air pressure.Automatic OffAutomatic Off is a safety feature that stops insulin delivery and triggers an Error if no keys are pressed within a programmed time period in RUN mode. See the entry in chapter 5 Persona-lizing your pump.Basal rateThis is the amount of insulin delivered per hour that is required to cover your basic insulin needs. In insulin pump therapy, your basal rate is determined together with your doctor or healthcare team and can be adjusted to meet your individual physiological needs throughout the day. Your basal rate is delivered by your Accu-Chek Spirit Combo insulin pump according to the curve of your personal basal rate prole or proles.Basal rate proleYour Accu-Chek Spirit Combo insulin pump offers you the option of delivering up to ve different basal rate proles in order to easily meet your changing insulin needs (for example during the week rather than at the weekend). A basal rate prole consists of 24 programmed hourly basal rates.Basal rate totalThe sum of all 24 hourly basal rates in one basal rate prole is called the (daily) basal rate total.
210Bluetooth ® wireless technology The term “Bluetooth” refers to a wireless technology that allows digital devices to transfer data at high speed. This technology is common in many portable devices such as portable PCs, Personal Digital Assistants and mobile telephones.BolusThe amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake and your activity level.Carrying systemA wide variety of carrying systems made of different materials are specially designed to suit your individual needs while wearing your Accu-Chek Spirit Combo insulin pump.CartridgeThe insulin reservoir of your Accu-Chek Spirit Combo insulin pump. It holds 3.15 ml (315 U) of rapid-acting insulin.Cartridge compartmentThe chamber in your Accu-Chek Spirit Combo insulin pump for the cartridge.Daily insulin totalThe total amount of insulin delivered (basal rate plus boluses) delivered in a 24-hour day, beginning at midnight. This amount does not include any insulin needed for the priming of infusion sets.Factory settingsYour Accu-Chek Spirit Combo insulin pump is provided by Disetronic Medical Systems with a standard conguration (factory settings). These settings can be adapted to your individual needs directly on your Accu-Chek Spirit Combo insulin pump or by using the Accu-Chek Insulin Pump Conguration Software. Hourly basal rateAn hourly basal rate is the amount of insulin delivered by your Accu-Chek Spirit Combo insulin pump in three-minute intervals for each hour.
211 Infusion setInfusion sets connect your Accu-Chek Spirit Combo insulin pump to your body. The insulin is delivered from the cartridge through the infusion set tubing and cannula or needle into your subcutaneous tissue. Infusion sets can be disconnectable or non-disconnectable.Infusion siteThe place where the infusion set cannula or needle is inserted into your subcutaneous tissue to deliver insulin.InsulinA hormone that helps cells transform glucose into energy. Insulin is produced in the beta cells of the pancreas (also called islets of Langerhans).Insulin (rapid-acting)A type of insulin created using recombinant DNA technology. The onset time of insulin analogue is shorter than the onset time of regular insulin.IPX8 according to IEC 60529Protection against the effects of temporary immersion in water. Ingress of water in quantities causing damage is not possible when the device is temporarily immersed in water under standardized conditions (maximal 60 minutes a day and 2.5 meters [8 feet]).Luer-lock connectorA standardized tting at the end of the infusion set which allows to tightly connect the infusion set and cartridge through the adapter. MeterSee Accu-Chek Aviva Combo.OcclusionAn occlusion is a blockage which prevents the insulin from owing correctly from the insulin pump into the body.
212Personal settingsYour Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings prior to starting insulin pump therapy. Personal settings include the basal rate prole(s), the correct time and date and all other variable values which can be tailored to your individual needs on your Accu-Chek Spirit Combo insulin pump or using Accu-Chek Insulin Pump Conguration Software.Rapid-acting Insulin See Insulin (rapid acting).RUNDuring normal use, your Accu-Chek Spirit Combo insulin pump is in RUN mode and insulin is continuously delivered. Boluses, Temporary Basal Rates and almost all functions can be pro-grammed from RUN mode.RUN screenThe RUN screen is the starting point for all functions which can be accessed while your Accu-Chek Spirit Combo insulin pump delivers insulin. Your Accu-Chek Spirit Combo insulin pump displays the RUN screen during normal use when no programming is being performed. The time, current hourly basal rate, selected basal rate prole and all currently activated functions appear on the RUN screen. SettingsSettings are individually programmable values and parameters that affect the way your Accu-Chek Spirit Combo insulin pump works.ScrollingScrolling allows a fast and easy programming of a range of values.STOPWhen your Accu-Chek Spirit Combo insulin pump is in STOP, it does not deliver any insulin. The insulin delivery is only stopped if an Error occurs or if your Accu-Chek Spirit Combo insulin pump is put into a necessary STOP, (e.g. when changing the cartridge, adapter or infusion set or for data transfer). Functions such as Extended Bolus or Temporary Basal Rate are interrupted by putting your Accu-Chek Spirit Combo insulin pump into STOP.
213 STOP screenThe STOP screen is the starting point for all functions that require that your Accu-Chek Spirit Combo insulin pump does not deliver insulin.Temporary Basal RateTemporary increase or decrease of your basal rate prole in percentages (from 0 – 250 %) to match changing insulin needs due to increased or decreased activity level, illness or stress.U100This is the insulin concentration. Each milliliter of liquid contains 100 International Units of insulin. Your insulin pump has been developed exclusively for delivery of U100 rapid-acting insulin.
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215 IndexAAbbreviations .................................... 194Accessories .................................... 1, 19Accu-Chek Aviva Combo .......................... 7, 133Adapter ................................ 1, 20, 150, 193ADVANCED user menu ......................... 100, 120Air bubbles .......................... 20, 42, 49, 50, 173Aircraft .................................. 63, 135, 141Alarm data menu ................................. 107Alarm signals ............................. 14, 116, 172Automatic Off ................................ 129, 160BBasal rate prole ..................... 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 ....................................... 14, 17CCartridge .................................. 42, 44, 73Cleaning your pump ............................... 149Conguration 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, 17QUICK INFO screen ........................... 12, 106RUN screen .................................... 11STOP screen ................................... 12Disposing of your pump ............................ 150
216EElectromagnetic 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 ..................................... 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
217 RReminderslist of ................................... 170, 221Reminder 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-Warningconrming ............................... 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, 220Temporary Basal Rate historyviewing ...................................... 109Therapy settings .................................. 126Time and DateSettings .................................... 32, 33Time remaining (pump timer) ........................ 110Transferring Data .............................. 12, 111Travelling ........................................ 63Troubleshootingtherapy-related issues ........................... 172UUnlocking Keylock ................................ 114User menuselecting ..................................... 101WWarning historyviewing ...................................... 107Warningslist of .......................................153
218Warnings and Errors ............................... 151conrming .................................... 152handling ...................................... 140Warranty ................................. 21, 170, 206Wearing your pumpcarrying systems ......................... 61, 62, 193in hazardous areas ............................... 62
219 ErrorsNo Error What you have to doE1 CARTRIDGE EMPTY Change the cartridge.E2 BATTERY EMPTY Change the battery.E3 AUTOMATIC OFF Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary.E4 OCCLUSION Change the cartridge and infusion set. See section 2.6 to 2.9.E5 END OF OPERATION (“Backup” pumps only)Arrange for immediate replace-ment of your Accu-Chek Spirit Combo insulin pump. Contact your healthcare professional for alternative insulin 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 (loaner pumps only)Arrange for immediate replace-ment of your Accu-Chek Spirit Combo insulin pump. Contact your healthcare professional for alternative insulin 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.Quick reference table for Errors, Warnings and Reminders
220WarningsNo Warning What you have to doW1 CARTRIDGE LOW Change cartridge before it is completely empty.W2 BATTERY LOW Replace the battery as soon as possible.W3 REVIEW TIME Set the time and date.W4 CALL FOR UPDATE Contact your local pump support.W5 PUMP TIMER (“Backup” pumps only)In the MY DATA menu check for the remaining operation time under the menu PUMP TIMER. Arrange for re-placement of pump within the scheduled pump operation time.No Warning What you have to doW6 TBR CANCELLED Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary. Ensure the cancella-tion was intended and program a new Temporary Basal Rate if necessary.W7 TBR OVER Decide whether a further Temporary Basal Rate change is appropriate and program one if necessary.W8 BOLUS CANCELLED Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary. Ensure that the cancellation was intended and program a new bolus if necessary.
221 No Warning What you have to doW9 LOANTIME WARNING (loaner pumps only)In the MY DATA menu, check for the remaining insulin pump loan time under the menu PUMP TIMER. Arrange for replacement of pump within the scheduled pump loan time.W10 BLUETOOTH FAULT Re-do pairing procedure for insulin pump and Meter. See section 6.4 Troubleshooting the Bluetooth ® connection in the User Guide for detailed information.ReminderNo Reminder What you have to doReminder Put your Accu-Chek Spirit Combo insulin pump into RUN if necessary.Some Reminders and Warnings are country specic and may never occur on your pump.
222My notes
223 Bluetooth ® registrationPlease note that in Italy and France Bluetooth ® wireless technology is for indoor use only.FCC ID RAH3IC ID7937A-3This Class B digital apparatus complies with Canadian ICES-003.Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installa-tion. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interfer-ence will not occur in a particular installation. If this equipment does 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 one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equip-ment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio / TV technician for help. Changes or modications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
224

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