Page 1 Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and trade names are those of their respective owners. ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK AVIVA COMBO,...
Page 2: Your Insulin Pump
Your insulin pump Your contact for assistance with and /or additional information about your Accu-Chek Spirit Combo insulin pump: United Kingdom South Africa Distributed in the United Kingdom by: Accu-Chek Customer Care Centre: Roche Diabetes Care Limited 080-DIABETES (Dial 080-34-22-38-37) Charles Avenue, Burgess Hill www.diabetes.co.za...
Page 3 Pump details and accessories Battery key Battery cover Battery Infrared window (next to Battery cover) Adapter Cartridge Compartment Cartridge Piston rod End plate Cartridge plunger man_05957613001_E_en.indb 1 02.03.2015 10:43:49...
Page 4 Overview of ADVANCED user menu Press d to move forwards STOP Press d + a simultaneously to move backwards Press f to select or save Press a to go up Press s to go down = Basal Rate Profile 2–4 BRP 4 man_05957613001_E_en.indb 2 02.03.2015 10:43:51...
Page 5 Overview of STANDARD and CUSTOM user menus Accessible menus in CUSTOM user STOP menu can be selected using Accu-Chek PC software (sold separately). Press d to move forwards Press d + a simultaneously to move backwards Press f to select or save Press a for up Press s for down = not accessible in STANDARD...
Page 6 Do not use your pump for the delivery of medication other than healthcare professionals. It contains all the necessary information U100 short-acting regular human insulin or rapid-acting insulin for safe and efficient use of your Accu-Chek Spirit Combo insulin analogue. pump. Regardless of your level of experience with pump therapy,...
Page 7 A “Caution” informs you about risks to your device. Malfunction or damage may result if you do not follow these instructions. A “Note” contains important information relating the efficient and smooth operation of your new Accu-Chek Spirit Combo insulin pump. man_05957613001_E_en.indb 5...
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Page 9: Table Of Contents
Understanding your new system Your insulin pump and water Changing the infusion set Overview Changing the cartridge and infusion set Display and sounds General safety information Keys and key combinations Accessories and disposables Boluses and Temporary Basal Rates Emergency kit Understanding boluses General safety information Programming a Standard Bolus...
Page 10 Using the Accu-Chek Spirit Combo insulin Appendix A: Technical Data pump with the Meter Appendix B: Configuration parameters Appendix C: Sterile products and accessories Meter Appendix D: Abbreviations Switching Bluetooth ON and OFF ® Appendix E: Beeps and melodies Pairing your pump with the Meter...
Page 11: Understanding Your New System
Your Accu-Chek Spirit Combo insulin pump has many helpful features that help to ensure safe and efficient pump therapy. Your Accu-Chek Spirit Combo insulin pump has been designed to adapt to your level of experience in pump therapy – whether you Note In this User Guide the term “Meter”...
Page 12 See chapter 5 Personalizing your pump. Data transfer Five basal rate profiles The infrared port on the bottom of your Accu-Chek Spirit Combo You can choose from 5 basal rate profiles, in line with your insulin pump enables you to transfer information between your different daily routines.
Page 13: Display And Sounds
As well as Warnings and Errors, your pump can signal Remind- ers. This works like an electronic alarm clock. Your Accu-Chek Spirit Combo insulin pump has a Liquid Crystal Display (LCD) screen. This display, together with the 4 keys, Choice of batteries enables you to program the pump.
Page 14 1.2.1 Backlight 1.2.2 Rotating display The backlight helps you to read the information on the display in Your pump’s display can be rotated through 180 degrees. See poorly-lit areas. You can turn on the backlight while in RUN or section 5.6.4 Display orientation. STOP mode, or when navigating through the menus, by pressing Note that when you rotate the display, the s and a key functions are reversed.
Page 15 1.2.3 Display screens RUN screen By default the screen is blank, to save energy, and becomes The screens displayed by your pump relate to one of following blank again after 20 seconds. By pressing any key, the RUN modes: screen is displayed when the pump is in RUN mode. This means RUN, STOP and Quick Info that insulin is being delivered to your body according to the basal Information...
Page 16 The RUN screen also displays Reminder information (such as The STOP screen also displays Reminder information (such as “cartridge low”) and special functions (such as Key Lock – “battery low”) and special functions (such as Key Lock – locked locked or unlocked) in the form of symbols. (See Appendix F: or unlocked) in the form of symbols.
Page 17 1.2.4 Navigating through the screens By pressing f again you enter the BOLUS DATA function. You can view the last 30 boluses by pressing a or s. The following procedure explains how to navigate through the screens. Think of these screens as menu choices. See section 1.2.3 Display screens.
Page 18 In any sub-menu the same key combination will move you back Your Accu-Chek Spirit Combo insulin pump informs you of the to the main menu screen. status of your pump using audible beeps, vibrations and displayed messages.
Page 19: Keys And Key Combinations
You then hear a melody, confi rming that the STOP- Warning has been turned off. If you press the key too briefl y, the You use the 4 keys on the Accu-Chek Spirit Combo insulin pump STOP-Warning will not be turned off.
Page 20 Turn off the STOP-Warning (press and tip of your fingernail, as this could damage the casing of your hold 3 sec. until you hear a melody) Accu-Chek Spirit Combo insulin pump. Instead, use the pad of your fingertip to avoid puncturing the keys. man_05957613001_E_en.indb 16...
Page 21 1.3.1 Combining keys WARNING You can obtain additional functions by pressing 2 keys If the keys on your pump are not functioning properly, simultaneously. In the following table, a plus symbol (+) indicates disconnect your pump and contact your local pump support that both buttons must be pressed at the same time.
Page 22 The Key Lock feature enables you to lock all 4 keys on your sometimes be pressed several times until the desired value is Accu-Chek Spirit Combo insulin pump. This is a valuable safety shown, with each press of the key changing the figure by a small measure that prevents you from accidentally activating your increment.
Page 23: Accessories And Disposables
High-quality sterile disposables and accessories are a vital use sterile disposables and accessories that are designed for part of the Accu-Chek Spirit Combo insulin pump system, and use with your Accu-Chek Spirit Combo insulin pump. The help to ensure safe pump therapy. Always follow the instructions correct functioning of your pump can only be guaranteed if you provided by your doctor or healthcare team –...
Page 24 1.4.2 Adapter Note It is essential to change the adapter at least every 2 months. You must also change the adapter if the seals vents become worn, are lost, or if the vents are blocked. 1.4.3 Battery grip Your pump requires one AA 1.5 V battery in order to function. Use seal AA high-quality alkaline LR6 or lithium FR6 batteries that have a minimum capacity of 2500 mAh.
Page 25 For a list of recommended accessories and disposables, see Appendix C. 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 cover The battery cover seals the battery compartment, and must be changed at least every 2 months.
Page 26: Emergency Kit
1.5 Emergency kit It is highly recommended to keep accessories and disposables WARNING with you in case of an emergency. This enables you to change these items if necessary. Such an emergency kit should contain: Make sure that you have an alternative therapy plan, provided An Accu-Chek infusion set by your healthcare professional.
Page 27: General Safety Information
If you should drop your pump, immediately inspect it carefully to avoid inappropriate insulin delivery. This phrase means that for damage. Do not use your Accu-Chek Spirit Combo insulin either too much or too little insulin is delivered. Too much insulin pump if cracks or chips are visible –...
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Page 29: Getting Started
2.2 Inserting the battery This chapter explains how to prepare your pump and begin insulin pump therapy. Your Accu-Chek Spirit Combo insulin pump turns on as soon as you insert the battery. When you remove the battery, your pump 2.1 Before you begin keeps track of the time and date for about one hour.
Page 30 Procedure for inserting and changing the battery Remove or disconnect your infusion set from the infusion site, to ensure that there is no risk of accidental insulin delivery. 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.
Page 31 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. Place the cover on the positive end and gently push the battery in, while turning the cover clockwise to partially tighten it.
Page 32 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.
Page 33: Start-Up Process
2.3 Start-up process When you … Then … change only the the start-up process begins at the Your pump runs a start-up process when you insert a battery or cartridge SELF-TEST screen. when you change the cartridge. During this process, your pump performs a series of internal tests.
Page 34 WARNING If you cannot hear the beeps from your Accu-Chek Spirit Combo insulin pump, you may not be notified of changes within the pump in time to take action. The BEEP TEST screen appears and your The VIBRATION TEST screen appears and If you do not hear the beeps, stop pump beeps.
Page 35 The display turns black. Check that the If your pump detects a Warning or an After the self-test, press a or s to display is completely black. Error during the start-up process, it select the type of battery you inserted. signals the Error or Warning at this point.
Page 36: Setting The Time And Date
2.4 Setting the time and date It is essential to set the time and date correctly, because basal WARNING rates and history information are stored on the basis of the time Incorrect setting of the time and date can lead to incorrect and date set in the pump.
Page 37 Procedure for setting the time and date Press d to move to the TIME AND DATE The HOUR screen is displayed. Press d to move to the MINUTE screen. SETTINGS screen. Press a or s to set the hour. Press a or s to set the minute. Press f to select.
Page 38 Press d to move to the TIME FORMAT Press d to move to the DATE FORMAT screen. screen. Press a or s to set the time format. Press a or s to set the date format. Press f to save and exit. man_05957613001_E_en.indb 34 02.03.2015 10:44:01...
Page 39: Your Basal Rate Profile
2.5.1 Programming your basal rate profile An Accu-Chek Spirit Combo basal rate profile consists of up to 24 different hourly basal rates. Each hourly rate may be changed Your Accu-Chek Spirit Combo insulin pump delivers insulin independently.
Page 40 Your basal rate profile should be reviewed: After any programming changes are made to your pump After a new battery is inserted After confirming the Error E7: ELECTRONIC ERROR. Note Insulin delivery does not stop or pause during basal rate programming. Procedure for programming your basal rate profile Press d to move to the BASAL RATE Press f to select.
Page 41 Note The increments shown depend on the programmed basal rate: it will 0.01 U from 0.05 U to 1.00 U, 0.05 U from 1.00 U to 10.0 U and Press a or s or scroll to set the 0.1 U from 10.0 U to 50.0 U Press d to move to the next hour.
Page 42 Copying an hourly basal rate If 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. Press d to move to the BASAL RATE Press f to select.
Page 43 Check the new daily BASAL RATE TOTAL. screen. undo the changes Wait for your Accu-Chek Spirit Combo insulin pump to Press f to save and exit. return to the RUN or STOP screen, or Press d and a simultaneously (exit feature) to exit the Function screen.
Page 44 Selecting a basal rate profile When you have programmed more than one basal rate profile (ADVANCED or CUSTOM MENU), you can select the required profile. Press d to move to the BASAL RATE Press f to select. SELECTION screen. The SELECT PROFILE for the current basal rate profile is displayed.
Page 45 Note When you change your user menu for example from Basal rate and bolus ADVANCED to STANDARD, your current basal rate profile During normal use, your pump is in RUN mode and insulin is may not appear. continuously delivered to your body, according to the basal rate profile you have programmed.
Page 46: Connecting The Cartridge, Adapter And Infusion Set
(for filling instructions see the instructions for use provided with this product) Insulin can flow uncontrolled from the cartridge or infusion set if An Accu-Chek Spirit Combo insulin pump adapter the cartridge plunger and the piston rod are not properly A new Accu-Chek infusion set connected and the pump is positioned at a higher level than the infusion site.
Page 47 Procedure to connect the cartridge, adapter and infusion set Remove the protective cap from the Push the adapter all the way onto the Carefully prepare a new Accu-Chek cartridge. (Do not touch the cartridge tip.) cartridge tip, to the stop. infusion set, following the instructions supplied for use.
Page 48: Inserting The Cartridge
A fi lled Accu-Chek Spirit 3.15 ml Cartridge System with a Do not use your pump for the delivery of medication other than connected Accu-Chek Spirit Combo insulin pump adapter U100 short-acting regular human insulin or rapid-acting insulin A new Accu-Chek infusion set analogue.
Page 49 Press d to move to the CARTRIDGE Make sure your infusion set is discon- CHANGE screen. nected and the cartridge has been Remove the cartridge, if necessary. removed. Unscrew carefully. Do not pull the Press f to select. cartridge out until it is completely Press and hold f for 3 seconds, until unscrewed.
Page 50 Hold your pump upright. Hold the new see step 10 fi lled cartridge so that the connected adapter and infusion set points upwards, parallel, and close to the cartridge compartment. see step 11 Make sure that the top edge of the threaded part of the adapter is level with the top of the cartridge compartment.
Page 51 It is not necessary to apply pressure. Do not over-tighten the adapter, other- wise it will be diffi cult to remove the cartridge, adapter and cartridge plunger, and could cause damage to your pump. Position your insulin pump upright (with the adapter pointing upwards).
Page 52 See section 2.8 Priming the infusion set. Start from step 4 in the Procedure for priming the infusion set. Press f after correctly inserting the When the self-test process is finished, cartridge. the INFUSION SET PRIMING screen is displayed. Your pump performs a self-test. See section 2.3 Start-up process.
Page 53: Priming The Infusion Set
The Accu-Chek Spirit Combo insulin pump stops priming at body. 25 units of insulin. If no insulin emerges from the needle or there...
Page 54 Procedure for priming the infusion set Press d to move to the STOP YOUR The pump displays the STOP screen, and PUMP screen. insulin delivery stops. Prepare the tubing or cannula for priming Press f to select. according to the infusion set’s instruc- tions for use.
Page 55 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.
Page 56: Positioning The Infusion Set
Always follow the instructions given to you by your doctor or Have the following materials ready: healthcare team and the instructions for the infusion set you Your Accu-Chek Spirit Combo insulin pump are using. A disinfectant for your skin A new Accu-Chek infusion set Change your infusion set as frequently as recommended by the manufacturer.
Page 57 2.9.2 Inserting the cannula Make sure that your pump is properly connected (including cartridge, adapter and infusion set) and correctly pro- grammed with your personal settings. Make sure your pump is in STOP mode. Wash your hands thoroughly. Disinfect the infusion site and let it dry Insert the cannula of your Accu-Chek completely.
Page 58 Accu-Chek Spirit Combo set you are using. Failure to do so could result insulin pump.
Page 59: Starting Insulin Delivery
2.10 Starting insulin delivery Procedure for starting insulin delivery Your pump is in STOP mode. Press d to move to the START YOUR Press f to select. Your pump shows the PUMP screen. RUN screen. Insulin delivery begins within 3 minutes. man_05957613001_E_en.indb 55 02.03.2015 10:44:15...
Page 60: Stopping Insulin Delivery
CAUTION actions when the pump is in STOP mode. These functions and actions include: When your Accu-Chek Spirit Combo insulin pump is in STOP changing the cartridge mode, no insulin is delivered to your body. You must put your connecting and disconnecting the adapter and / or infusion set pump into RUN mode to continue insulin delivery.
Page 61: General Safety Information
Do not re-use single-use materials because this might lead to seconds. You then hear a melody and / or feel a vibration, a malfunction of your Accu-Chek Spirit Combo insulin pump, confirming that the STOP-Warning has been turned off. incorrect insulin delivery and / or infection. Always handle these items with clean hands.
Page 62 The support of a doctor or healthcare team is vital when pump, in order to avoid incorrect insulin delivery. Record your training on and using your Accu-Chek Spirit Combo insulin personal settings from your current insulin pump, and ensure pump. Regular visits to your doctor or healthcare team are also that they are correctly programmed into your new Accu-Chek essential during insulin pump therapy.
Page 63 Note 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.
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Page 65: Using Your Pump In Daily Life
Using your pump in daily life 3.1.1 When not to wear your pump This chapter provides important guidelines on how to use your pump safely from day to day. Electromagnetic fields and hazardous areas 3.1 Wearing your pump WARNING Attach your pump safely to your body or clothes to prevent Do not use your pump near electromagnetic fields such as damage.
Page 66 Exercise is an important part of diabetes management. Your department stores, should not normally affect the functioning of Accu-Chek Spirit Combo insulin pump is designed to enable you your pump. to safely perform a range of sporting activities while wearing your pump.
Page 67 3.1.3 Travelling with your pump Note Rapid and extreme changes in air pressure, for example in an air plane that is taking off or when practising sports like hang-gliding, can influence insulin delivery, especially Ask your doctor or healthcare team about any special steps you if there are air bubbles in the cartridge or tubing.
Page 68: Interruption Of Insulin Pump Therapy
3.2 Interruption of insulin pump therapy Consult 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 delivery interruption. Use a syringe or insulin pen to inject insulin according to the instructions of your doctor or healthcare team.
Page 69 3.2.1 Short interruptions Press d to move to the STOP YOUR Press f to put your pump in STOP PUMP screen. 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.
Page 70 3.2.2 Long interruptions When you need to interrupt your pump therapy for more than one day, use the following procedure. Put your pump into STOP mode. Remove the cartridge, adapter, and infusion set. Reinsert the adapter. Remove the battery and reinsert the battery cover.
Page 71: Your Insulin Pump And Water
3.3.1 Accidental contact with water CAUTION Before any contact with water, disconnect and take off your Your Accu-Chek Spirit Combo insulin pump is protected against brief accidental contact with water. Examples of accidental water Accu-Chek Spirit Combo insulin pump. Check your pump daily...
Page 72 CAUTION Put your pump into STOP mode, disconnect the pump from your Avoid any contact between your Accu-Chek Spirit Combo body, and inspect it. Use a soft cloth to dry the outside of the insulin pump, the infusion set, and the connecting parts of...
Page 73: Changing The Infusion Set
3.4 Changing the infusion set When you change the infusion set, keep the following information Always disconnect your infusion set before changing a in mind: cartridge or priming the infusion set. Otherwise, you risk Infusion sets are sterile products intended for single use only. uncontrolled insulin delivery into your body.
Page 74 Procedure for changing the infusion set Have the following materials ready: Your Accu-Chek Spirit Combo insulin pump A disinfectant for your skin A new Accu-Chek infusion set Make sure your pump is in STOP mode. Wash your hands thoroughly. Tip: The battery key has a notch that fi ts...
Page 75 Screw the Accu-Chek infusion set Remove the used infusion headset and Carefully prepare a new Accu-Chek clockwise into the adapter. dispose of it correctly. infusion set for use. Carefully tighten the luer-lock connector by hand. Prime the infusion set following the Put the pump in RUN mode.
Page 76 Note If you use a soft-cannula type infusion set, you must begin with a bolus to fill the air space in the cannula and headset, according to the instructions for the infusion set you are using. Failure to do so could result in inadequate insulin dosing.
Page 77: Changing The Cartridge And Infusion Set
3.5 Changing the cartridge and infusion set Have the following materials ready: Your Accu-Chek Spirit Combo insulin pump A disinfectant for your skin A new Accu-Chek infusion set A fi lled Accu-Chek Spirit 3.15 ml Cartridge System A new adapter (this must be changed at least every...
Page 78 If this should happen, please call your local pump support (see inside back cover). Hold your Accu-Chek Spirit Combo insulin Remove the adapter and cartridge from pump with the adapter pointing down- your pump by unscrewing the adapter wards.
Page 79 Hold the adapter to the light to check for If necessary, clean the adapter using Insert a new cartridge and a new infusion signs of wear or dirt (especially on the water and dry it. If it shows signs of wear set.
Page 80: General Safety Information
3.6 General safety information Note Check the amount of insulin remaining in the cartridge at WARNING least once a day. Press f from the RUN or STOP screen Always carry spare sterile products and accessories (infusion to display the remaining cartridge content in units. Before going to sleep, make sure that: set, insulin cartridge, batteries), an insulin pen/syringe, and insulin.
Page 81: Boluses And Temporary Basal Rates
Boluses and Temporary Basal Rates 4.1 Understanding boluses Your pump can deliver 3 types of bolus: A bolus is the amount of insulin delivered (in addition to the basal Standard Bolus fast delivery rate) to cover the intake of food and to correct high blood glucose levels.
Page 82: Programming A Standard Bolus
4.2 Programming a Standard Bolus Note You can not program a new Standard Bolus as long as one Standard Bolus, Quick Bolus or the immediate part of There are 2 ways to program a Standard Bolus: a Multiwave Bolus is running. Quick Bolus Using a and s on your insulin pump, with bolus increments...
Page 83 4.2.1 Programming a Quick Bolus The following process uses only the a and s keys. You can looking at the pump screen. After the bolus is programmed, you start with either key. The recommended steps below are those can count the beeps and vibrations of your pump to check the described with the fi rst key appearing without round brackets, correct programming.
Page 84 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.
Page 85 4.2.2 Cancelling a Quick Bolus During programming Press the s or a key you used to enter the Quick Bolus programming No bolus is delivered. (the bolus amount option. This will reset the bolus amount to 0.0 units. You hear a melody. blinks): If no new bolus is programmed, your pump returns to the RUN screen and beeps 3 times and vibrates after 5 seconds.
Page 86 4.2.3 Programming a Standard Bolus using Standard bolus menu Independent of the bolus increment setting, the bolus increments for the menu-guided Standard Bolus are fixed 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 Press d to move to the STANDARD displayed.
Page 87 After this bolus delivery start delay, your pump beeps 3 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 Bolus During programming You have 3 options for cancelling during programming: No bolus is delivered.
Page 88: Programming An Extended Bolus
4.3 Programming an Extended Bolus Cancellation during the start delay and during the bolus delivery will cause a WARNING W8: BOLUS CANCELLED. Press f twice to confirm and snooze the Warning. See chapter 8. The Extended Bolus option enables you to program a bolus to be delivered over a period of time.
Page 89 Tip: You can add a Standard or Quick Bolus to an ongoing If you want to program a different Extended Bolus, put the pump Extended Bolus. If you cancel the Standard Bolus, the Extended in STOP mode to cancel the current bolus and to program a new Bolus continues to run.
Page 90 Tip: Press d to switch between programming the bolus amount and bolus duration. Press d to move to the BOLUS Press f to confirm the bolus amount DURATION screen. and duration. The pump returns to the RUN screen. The bolus delivery begins Press a to increase or s to decrease within the next 3 minutes.
Page 91 4.3.1 Cancelling an Extended Bolus During programming You can either: No bolus is delivered. (the bolus amount or wait for your pump to return to the RUN screen. bolus duration blinks): press d and a simultaneously to exit the Function screen. set the bolus amount to 0.0 units and press f.
Page 92 Note If a Temporary Basal Rate is active at the same time, See chapter 8 Warning W6: TBR CANCELLED and it is also cancelled when your pump is put into Warning W8: BOLUS CANCELLED. Make sure that the STOP mode. A Warning W8: BOLUS CANCELLED and cancellation was deliberate and then program a new a Warning W6: TBR CANCELLED are displayed.
Page 93: Programming A Multiwave Bolus
4.4 Programming a Multiwave Bolus The Multiwave Bolus option is available in the ADVANCED user When programming a Multiwave Bolus, make sure that you are menu. It is designed to better simulate the body’s insulin using the ADVANCED user menu and your pump is in RUN mode. delivery, and combines an immediate bolus delivery followed by an Extended Bolus delivery.
Page 94 Procedure for programming a Multiwave Bolus Press d to move to the Multiwave Bolus Press f to select. The BOLUS AMOUNT Press a or s to increase or decrease screen. screen appears. the total bolus amount. Note The first time you press a, the bolus duration of the last Multiwave Bolus and a default immediate bolus amount appear.
Page 95 Tip: Press d to loop between program- ming the total BOLUS AMOUNT, IMMEDI- ATE BOLUS and BOLUS DURATION. Check the total and immediate bolus Press f to confirm both bolus amounts amounts and the Extended Bolus duration and the bolus duration. The Multiwave programmed on the screens.
Page 96 4.4.1 Cancelling a Multiwave Bolus During programming There are 3 ways to cancel a Multiwave Bolus during programming: No bolus is delivered. (the bolus amount Do not press any key for 20 seconds. The pump returns to the RUN screen. blinks): Return to the Multiwave Bolus screen by pressing d + a simultaneously.
Page 97: Programming A Temporary Basal Rate (Tbr)
4.5 Programming a Temporary Note If a Temporary Basal Rate is active at the same time, it is Basal Rate (TBR) also cancelled when your pump is put in STOP mode. The Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED is displayed.
Page 98 Note A running Temporary Basal Rate increase or decrease remains active, even if you have changed the basal rate profile. You can only program a Temporary Basal Rate when your pump is in RUN mode. Procedure for programming a Temporary Basal Rate Note If no Temporary Basal Rate is currently active, the percentage is set to 100 %.
Page 99 Tip: When you increase (or decrease) the Temporary Basal Rate, the duration of your previous Temporary Basal Rate increase (or decrease) appears. However, Press a or s to increase or decrease when you use your pump for the first Press d to move to the TBR DURATION the basal rate.
Page 100 Note During Temporary Basal Rate delivery, the increase or TBR OVER Alert decrease in percentage, the increased or decreased At the end of a Temporary Basal Rate, a Warning W7: TBR OVER hourly basal rate (hourly basal rate plus TBR percentage), is displayed.
Page 101 4.5.1 Cancelling a Temporary Basal Rate During programming: There are 3 ways to cancel a Temporary Basal Rate during programming: Pump continues to Do not press any key for 20 seconds. The pump returns to the RUN screen. deliver normal basal Return to the Temporary Basal Rate (TBR) screen by pressing d + a rate.
Page 102: General Safety Information
4.6 General safety information Note If an Extended Bolus or a Multiwave Bolus is active at the WARNING same time, it is also cancelled when your pump is put into STOP mode. A Warning W8: BOLUS CANCELLED and a Incorrect programming of your insulin pump may cause Warning W6: TBR CANCELLED are displayed.
Page 103: Personalizing Your Pump
Your 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 5.1 Introduction...
Page 104 Note For your safety and convenience during programming, become more experienced, you may wish your Accu-Chek Spirit Combo insulin pump returns to the to change to the ADVANCED user menu. RUN or STOP screen if no key is pressed within 20 seconds.
Page 105: Selecting A User Menu
5.2 Selecting a user menu Note 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 provider. Procedure for selecting a user menu Press d to move to the MENU SETTINGS The SELECT USER MENU screen is Press f to confirm.
Page 106 … if the previous basal rate profile is not Press a or s to select a basal rate available from the selected user menu, profile, if required. dashes appear instead. Check the (new) basal rate profile and its daily insulin total. Press f to save and exit.
Page 107: Standard User Menu
5.3 STANDARD user menu The 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 d to move forwards STOP Press d + a simultaneously to move backwards man_05957613001_E_en.indb 103...
Page 108 See section 5.2 Selecting a user menu earlier in this chapter. INFUSION SET PRIMING See section 2.8 Priming the infusion set. BLUETOOTH SETTINGS See chapter 6 Using the Accu-Chek Spirit Combo insulin pump START YOUR PUMP with the Meter. See section 2.10 Starting insulin delivery.
Page 109: Viewing Your Pump Data
5.4 Viewing your pump data The memory of your Accu-Chek Spirit Combo insulin pump stores Bolus history last 30 boluses all the events (Warnings and Errors, programming operations and insulin delivery records) up to 4500 events. This data corresponds Alarm history...
Page 110 5.4.1 Viewing your bolus history Each BOLUS DATA screen displays: Bolus type (Standard, Extended or Multiwave Bolus) The BOLUS DATA screen allows you to view up to the last Bolus duration (only displayed for an Extended or 30 bolus deliveries, starting with the most recent entry. Multiwave Bolus) Time Date...
Page 111 5.4.2 Viewing the Error and Warning history The alarm data menu allows you to view up to the last Each alarm data screen displays: 30 Warnings and Errors, starting with the most recent entry. Number and type of the Warning or Error (for example, W6) Warning or Error (for example, TBR CANCELLED) Time Date...
Page 112 5.4.3 Viewing the history of daily insulin totals This function allows you to view up to the last 30 daily totals of Each screen displays: insulin delivered (from midnight to midnight; including basal rate Daily total of insulin delivered plus boluses), starting with the most recent entry. Date Entry number (01 is the most recent) of total entries (example 01/04) of a daily insulin total...
Page 113 5.4.4 Viewing the Temporary Basal Rate history This option allows you to view up to the last 30 Temporary Basal Each TBR DATA screen displays: Rate (TBR) increases or decreases, starting with the most recent TBR increase or decrease in percentage entry.
Page 114 5.4.5 Viewing the time remaining (pump timer) in the RUN and STOP screen. When the operating time has expired, you will be prompted with an Error E5 or E9: END OF The pump timer function only occurs on a backup or loan pump. OPERATION, and the pump will turn to STOP mode.
Page 115: Transferring Your Data To A Computer
PC. For availability of the appropriate software see Appendix C. 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.
Page 116 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 When the data transfer is complete, selected.
Page 117: Pump Settings
The Key Lock function allows you to lock the 4 keys of your settings relating to your therapy, see 5.10 Therapy settings later Accu-Chek Spirit Combo insulin pump. This is an important in this chapter. safety measure that prevents you from accidentally activating functions, for example while sleeping or during contact sports.
Page 118 Procedure for unlocking the Key Lock If you press any key while the screen is blank, the Key Lock symbol indicates that the keys are locked. Note The Key Lock remains unlocked during fast bolus delivery of Standard or Multiwave Bolus. 3 seconds to confirm that the Key Lock is unlocked.
Page 119 5.6.2 Adjusting the sound volume Your pump emits different acoustic signals in different handling Note The volume of the STOP-Warning is independent of the situations to facilitate handling e.g. for blind or partially-sighted programmed beep volume – it always sounds at the users.
Page 120 5.6.3 Changing signal settings Beep only The Accu-Chek Spirit Combo insulin pump enables you to choose Vibrate only how you want your pump to alert you when a Warning or Error occurs. You have 3 options: Beep and vibrate For your safety, if you do not respond to the vibration, the pump starts beeping after one minute.
Page 121 5.6.4 Display orientation Note If you turn the display orientation of your pump by 180°, the functions of the a and s keys are also reversed. Your pump allows you to turn the display by 180°, so that you The functions of the d and f keys remains the same, can view it more easily, depending on how you are wearing the whichever screen orientation you choose.
Page 122 5.6.5 Setting the display contrast Your pump allows you to adjust the display contrast to suit your preferences. Procedure for setting the display contrast Press d to move to the PUMP Press d to move to the DISPLAY SETTINGS screen. CONTRAST screen.
Page 123 5.6.6 Selecting the language Your pump can display the information in several languages. You can chose the language according to your preferences. Procedure for setting the language Press d to move to the PUMP Press d to move to the LANGUAGE SETTINGS screen.
Page 124: Advanced User Menu
5.7 ADVANCED user menu The 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: Press d to move forwards STOP Press d + a simultaneously to move backwards...
Page 125: Basal Rate Profiles
See section 4.4 Programming a Multiwave Bolus. 5.8.1 Programming additional basal rate profiles 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.
Page 126 Procedure for Programming additional basal rate profiles See section 2.5.1 Programming your basal rate profile. Press d to move to the BASAL RATE The hourly basal rates for each additional PROGRAMMING (2, 3, 4, 5) screen you basal rate profile are set in the same way wish to program.
Page 127 5.8.2 Selecting a basal rate profile Procedure for selecting a basal rate profile Press d to move to the BASAL RATE Press a or s to select a basal rate SELECTION screen. profile. The selected basal rate profile and its daily insulin total appear. Press f to enter.
Page 128: Setting A Reminder
5.9 Setting a Reminder You 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. Procedure for setting single or multiple Reminders Press d to move to the REMINDER Press f to select.
Page 129 Press d to move to the HOUR screen. Press d to move to the MINUTE screen. Press a or s to set the hour. Press a or s to set the minute. Press f to save and exit. Turning off the Reminder When the Reminder sounds, the Reminder screen is displayed.
Page 130: Therapy Settings
5.10 Therapy settings These settings relate to the therapeutic use of the pump. For your Accu-Chek Spirit Combo insulin pump is adjustable. It is settings relating to the practical use of the pump, see Pump initially set to 0.5 units per key-press, but it can be changed settings earlier in this chapter.
Page 131 5.10.2 Adjusting the prime amount The prime amount needed to fill an infusion set depends on the Note The amount of insulin used for the priming is not added to length of the infusion set tubing. The shorter your infusion set the history of daily insulin totals.
Page 132 5.10.3 Locking basal rate profiles Your Accu-Chek Spirit Combo insulin pump allows you to adapt If you try to program a basal rate while the BASAL RATE LOCK is your hourly basal rate profile as needed. You can then lock...
Page 133 5.10.4 Automatic Off Automatic 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.
Page 134: Custom User Menu
5.11 CUSTOM user menu The CUSTOM user menu is designed to adapt your pump to your special requirements and preferences. It allows you or your healthcare provider to display or hide screens and thereby customize the individual user menus. STOP Press d to move forwards Press d + a simultaneously to move backwards...
Page 135 Note By default, the CUSTOM user menu contains all of the functions available except the following: Multiwave Bolus Basal rate profiles 3, 4 and 5 Therapy Settings To change the CUSTOM user menu, you, your doctor, or your healthcare provider must use the Accu-Chek PC configuration software.
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Page 137: Using The Accu-Chek Spirit Combo Insulin Pump With The Meter
Using the Accu-Chek Spirit Combo insulin pump with the Meter 6.1 Meter This chapter describes how the Accu-Chek Spirit Combo insulin pump works with the Meter, and explains how to pair the 2 devices using Bluetooth ® wireless technology. The Meter – available separately – is both a blood glucose meter and a remote-control device for your Accu-Chek Spirit Combo Note In this User Guide the term “Meter”...
Page 138 ® settings Display settings All 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 (Owners booklet) provided with this product.
Page 139: Switching Bluetooth ® On And Off
6.2 Switching Bluetooth ON and OFF ® To prolong the battery life and avoid accidental changes on your WARNING pump, you should switch off Bluetooth ® wireless technology, You must ensure that Bluetooth ® is switched off on both if the Meter is lost, stolen or, you plan not to carry it with you for devices before boarding an aircraft, as emissions from your a longer period of time.
Page 140: Pairing Your Pump With The Meter
If you have already acquired the Meter together with the You should not perform the pairing process in crowded areas, Accu-Chek Spirit Combo insulin pump, the 2 devices will already since the emissions of other electronic devices could interfere with have been paired.
Page 141 Note When Bluetooth ® is turned off, you cannot access the Paired If the pump screen indicates that no Device menu. paired device is available, turn on the Meter in pairing mode by holding down Pump screen * and simultaneously pressing +. Meter screen The pump begins searching and detects the Meter, displaying its serial number...
Page 142 The pump begins the pairing process and shows a 10-digit code. Enter the code on the Meter display, using =, Pump screen and then to move to the next digit. Confirm the complete code with .. Meter screen After the pairing is completed press + to turn off the Meter.
Page 143: Troubleshooting The Bluetooth Connection
6.4 Troubleshooting the Bluetooth ® connection In case of problems with the Bluetooth ® 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.
Page 144 6.4.1 Handling Warnings and Errors The 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 Meter’s Pump menu and snooze and confirm the Warning or Press d to move to the DELETE DEVICE Error through the Meter.
Page 145 6.4.2 Use in aircraft 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. man_05957613001_E_en.indb 141 02.03.2015 10:44:47...
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Page 147: Care And Maintenance
Care and Maintenance 7.1 Inspecting your pump This chapter explains how to take care of your pump and keep it properly maintained. Your pump must be properly maintained to guarantee accurate insulin delivery. CAUTION Check the pump display regularly during the day and before you Do not perform any servicing or repair on your Accu-Chek go to sleep, and especially if for any reason you might not be Spirit Combo insulin pump as this may void the guarantee.
Page 148 7.1.1 Checklist Check your pump daily, and make sure that: Your infusion site is secure, comfortable, and free of irritation The pump casing, the display, and the cartridge are not or infection. chipped or cracked and that the display does not show The cartridge is free of air bubbles.
Page 149: Damage To Your Pump
BOLUS CANCELLED or a Warning W6: TBR CANCELLED is pump! Use the specially designed pump carrying system to help displayed. avoid dropping your pump. See Roche sterile products and accessories catalogues and brochures for more information, or Press f twice to confirm and turn off the alert. The contact your local pump support (details on inside back cover).
Page 150: Your Insulin Pump And Water
Immediately inspect your pump if it is dropped. Do not use Avoid contact with water. Check daily that your Accu-Chek your Accu-Chek Spirit Combo insulin pump if chips, cracks Spirit Combo insulin pump is not chipped, cracked or damaged or other damages are visible. Otherwise water, dust, insulin...
Page 151 Other liquids You do not have to worry about contact between your pump and Your Accu-Chek Spirit Combo insulin pump is IPX8 waterproof perspiration or saliva. You must however check your pump when leaving the factory site. However hair-line cracks could immediately after contact with other liquids or chemicals such as: appear during use.
Page 152: Repair Of Your Pump
You may be requested to return your pump to Roche returned to you. (For the address, see inside the back cover.) for investigation.
Page 153: Maintaining Your Pump
The life of any battery is affected by how you If necessary, use a clean cloth with alcohol (isopropanol or use your Accu-Chek Spirit Combo insulin pump, your personal ethanol). If these measures are not successful, contact your local settings, delivery rates, temperature, and other factors.
Page 154: Storing Your Pump
2002 / 96 / EC and may not be disposed of with other electronic devices. If you need to dispose of your Accu-Chek Spirit Combo insulin pump, return it to Roche (address inside the back cover) To store your pump, place it in STOP mode, then: for professional disposal.
Page 155: Warnings And Errors
A safety system monitors and controls the function of your If you do not confirm a Warning or Error within 60 seconds, it will Accu-Chek Spirit Combo insulin pump. This safety system be signalled again. Even when the beep is turned off or pro- performs more than 9 million safety checks every day.
Page 156: Confirming A Warning Or Error
8.1 Confirming a Warning or Error When you confirm: When a Warning or an Error occurs: W1: CARTRIDGE LOW Press f to turn off the beeps and vibrations. The Warning or E1: CARTRIDGE EMPTY Error code stays on the display. W2: BATTERY LOW E2: BATTERY EMPTY W5: PUMP TIMER...
Page 157: List Of Warnings
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. If necessary, put your pump in RUN mode.
Page 158 Warning W2: BATTERY LOW Warning W3: REVIEW TIME The battery power is low. Be prepared for a battery change as The pump settings and history data are saved in memory soon as possible. The battery low symbol appears in the RUN or regardless of power loss.
Page 159 Warning W4: CALL FOR UPDATE Warning W5: PUMP TIMER (backup pumps only) Contact your local pump support (see inside back cover). Your pump’s operating time will expire soon. When the Warning W5: PUMP TIMER occurs, your pump has a remaining operating Press f twice to snooze and to confirm the Warning.
Page 160 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. If necessary, put your pump in RUN mode. Make sure that the cancellation was intended and then Note The Warning W5: PUMP TIMER and the Error E5: END OF program a new Temporary Basal Rate if necessary.
Page 161 Warning W7: TBR OVER (Temporary Basal Rate Over) Warning W8: BOLUS CANCELLED A Temporary Basal Rate has ended. The original basal rate A bolus was cancelled during the start delay or after delivery (100 %) will resume automatically once the Warning has began.
Page 162 Warning W9: LOANTIME WARNING (loan pumps only) Warning W10: BLUETOOTH FAULT The pump is coming to the end of its loan period. In the MY DATA You need to re-do the pairing procedure for the Accu-Chek menu, check the remaining loan time in the PUMP TIMER menu. Spirit Combo insulin pump and Meter.
Page 163: List Of Errors
Reconnect the infusion set or insert a new one. WARNING Put your pump in RUN mode. After the occurrence of an Error, your Accu-Chek Spirit Combo insulin pump is in STOP mode and insulin delivery is inter- See section 3.5 Changing the cartridge and infusion set.
Page 164 Press f twice to snooze and to confirm the Error. 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 f twice to snooze and to confirm the Error.
Page 165 Error E4: OCCLUSION If an Error E4: OCCLUSION (blockage) occurs, follow the steps listed below: WARNING Press f twice to turn off and to confirm the Error. If the Error E4: OCCLUSION occurs, immediately check your blood glucose level, and then check again about 2 hours later, as insulin delivery has been interrupted.
Page 166 In rare cases, the cartridge itself can be the cause of the Carry out the INFUSION SET PRIMING function (See section occlusion. If an Error E4: OCCLUSION occurs again, you 2.8 Priming the infusion set) without the cartridge, adapter, must change the cartridge. Follow the steps listed below: and infusion set inserted.
Page 167 Error E5: END OF OPERATION (backup pumps only) Note The Warning W5: PUMP TIMER and the Error E5: END OF The pump timer of your Backup pump has reached zero. The OPERATION are based on running time (the total time pump changes to STOP mode and will no longer operate.
Page 168 Error E6: MECHANICAL ERROR Reconnect the infusion set at your infusion site. A mechanical Error has been discovered during a routine Put your pump in RUN mode. automatic system check and insulin delivery has stopped. If the Error E6: MECHANICAL ERROR occurs again, use the Press f twice to snooze and to confirm the Error.
Page 169 Remove or disconnect the infusion set from your infusion site. Error E8: POWER INTERRUPT A power interrupt Error occurs when you insert a new battery without first placing the pump in STOP mode. See section 2.2 Inserting the battery for instructions on how to change the battery.
Page 170 Error E9: END OF OPERATION (loan pumps only) Note This setting is country-specific and may not be visible on The pump timer of your Loaner pump has reached zero. The your pump. pump changes to STOP mode and will no longer operate. An The Warning W9: LOANTIME WARNING and the Error E9: Error E9: END OF OPERATION appears on the display.
Page 171 Prime the infusion set. See sections 3.5 Changing the cartridge and infusion set and Reconnect the infusion set at your infusion site. 2.8 Priming the infusion set. Put your pump into RUN mode. If the Error E10: CARTRIDGE ERROR occurs during the WARNING rewinding of the piston rod, insert a new battery in the pump and repeat the procedure.
Page 172 Error E12: DATA INTERRUPTED will occur. The data transfer must be successfully completed before you Restart the data transfer. can put your Accu-Chek Spirit Combo insulin pump into RUN mode. Before you can put your pump in RUN mode, the data transfer must have been successfully performed.
Page 173 Error E13: LANGUAGE ERROR The language setting needs to be checked. Press f twice to snooze and to confirm the Error. Follow the steps in section 5.6 Pump settings to change the language. Put your pump in RUN mode. man_05957613001_E_en.indb 169 02.03.2015 10:44:49...
Page 174: List Of Reminders
8.4 List of Reminders Reminder R1: REMINDER Reminder R2: END OF WARRANTY A Reminder has been programmed on the pump. The 4-year warranty covering your insulin pump has expired. For any questions and concerns about the warranty, contact your Press f twice to snooze and to confirm the Reminder. local pump support (see inside back cover).
Page 175: Troubleshooting
This chapter describes problems that may occur when using Although your pump has an internal security check system, it your Accu-Chek Spirit Combo insulin pump. Any problems that cannot, for example, detect if your infusion set is leaking, if an generate a Warning or Error are described in chapter 8.
Page 176: Therapy-Related Issues
Contact your local pump support (details on inside back cover). are shown incompletely or not at all. Your Accu-Chek Spirit Combo insulin pump does not beep Check that the beep volume and alarm signals are turned on. Check the or vibrate.
Page 177 Problem Recommended Action There 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.
Page 178 Problem Recommended Action There 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.
Page 179: Appendix A: Technical Data
Appendix A: Technical Data General Technical Data Maximum dimensions Approx. 82.5 × 56 × 21 mm (without adapter) (3.2 × 2.2 × 0.8 inches) Weight an empty insulin pump: approx. 80 g (2.8 ounces) insulin pump inclusive battery, full plastic cartridge and infusion set: approx.
Page 180 General Technical Data Barometric pressure During operation: 50 to 106 kPa (500 to 1060 mbar) During transport or storage in its shipping case: 50 to 106 kPa (500 to 1060 mbar) Power supply One 1.5 volt AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 volt rechargeable NiMH AA (HR6) battery.
Page 181 General Technical Data Delivery Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed hourly basal rate, 24 hours a day. Minimal dose: 1/20 of the hourly basal rate, maximal 20 times per hour. Test interval: every 3 minutes.
Page 182 Cartridge Accu-Chek Spirit 3.15 ml Cartridge System and Accu-Chek 3.15 ml Plastic Cartridge with a luer connection. Aventis Insuman Infusat cartridges*** have been evaluated and approved for use with the Accu-Chek Spirit Combo insulin pump. man_05957613001_E_en.indb 178 02.03.2015 10:44:49...
Page 183 General Technical Data Infusion sets Accu-Chek infusion sets with a luer-lock connector. Accu-Chek Infusion sets are PVC and latex free. Data transfer Infrared interface Safety system Alert system, beeps, information on the display, vibrations, dual microprocessors. Your insulin pump is controlled by 2 microprocessors. The safety concept is based on one processor (supervisor processor) supervising the other (main processor).
Page 184 Guidance and manufacturer’s declaration – electromagnetic emissions The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.
Page 185 Guidance and manufacturer’s declaration – electromagnetic immunity The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of Accu-Chek Spirit Combo insulin pump should assure that it is used in such an environment.
Page 186 Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidance Voltage dips, short < 5 % UT (0.5 cycle) Not applicable interruptions and voltage 40 % UT (5 cycles) variations on power 70 % UT (25 cycles) supply lines <...
Page 187 Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the Accu-Chek Spirit Combo insulin pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Page 188 If the measured field strength in the location in which the Accu-Chek Spirit Combo insulin pump is used exceeds the applicable RF compliance level above, the Accu-Chek Spirit Combo insulin pump or the device, which contains it should be observed to verify normal operation.
Page 189 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.
Page 190 Note 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 reflection 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...
Page 191 The maximum deviation of the delivered amount (overall mean percentage flow error) for U100 insulin is ≤ ± 5 %*, where your Accu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3 feet) above / below the infusion site.
Page 192 Start-up graph over the stabilization period The start-up graph shows changes in the flow rate over the stabilization time. real flow target flow 0.012 0.010 0.008 0.006 0.004 0.002 0.01 ml is equivalent to 1 U (U100 insulin) 0.000 1080 1200 1320 1440...
Page 193: Appendix B: Configuration Parameters
Appendix B: Configuration parameters Maximum parameter Typical range available on range adjustable with the the pump and standard Accu-Chek PC Configuration parameter settings* Software Basal rate Hourly basal rate + max. TBR 62.5 U / h max. amount: 0 – 250.0 U / h (hourly basal rate combined with temporary basal rate, max.
Page 194 Maximum parameter Typical range available on range adjustable with the the pump and standard Accu-Chek PC Configuration parameter settings* Software Bolus Bolus amount per bolus delivery 25.0 U max. amount: 0 – 50.0 U bolus amount increments for Quick Bolus 0.5 U 0.1, 0.2, 0.5, 1.0 or 2.0 U bolus amount increments for Standard Bolus...
Page 195 Maximum parameter Typical range available on range adjustable with the the pump and standard Accu-Chek PC Configuration parameter settings* Software Battery type AA (LR6) ALKALINE, AA (FR6) LITHIUM or AA (HR6) NiMH rechargeable battery Key Lock turned on or off Automatic off turned on (1 –...
Page 196: Appendix C: Sterile Products And Accessories
Appendix C: Sterile products and accessories Cartridges Accu-Chek infusion sets Name Comments Name Comments Accu-Chek Spirit 3.15 ml Plastic cartridges are single-use Accu-Chek RapidLink All Accu-Chek infusion sets are Cartridge System items only. Do not re-use cart ridges. Accu-Chek Rapid-D available in various tubing and Accu-Chek 3.15 ml Plastic Refer to the instructions for use...
Page 197 Comments Name Comments Adapter Adapter and Battery Cover are part Carrying Systems All Accu-Chek Spirit Combo and Battery Cover of the Accu-Chek Spirit Combo Accu-Chek Spirit Carrying systems Service Pack and Accu-Chek are compatible with the Accu-Chek Spirit Combo Service Pack small.
Page 198: Appendix D: Abbreviations
Appendix D: Abbreviations Abbreviation Meaning Abbreviation Meaning NiMH Nickel Metal Hydrid (used with rechargeable approx. Approximately batteries) Basal Rate rel. Relative Basal rate profile sec. Seconds Hour (s) Temporary Basal Rate International Electrotechnical Commission See I.U. incl. Inclusive or including U / h Amount of International Units of insulin Infrared...
Page 199: Appendix E: Beeps And Melodies
Appendix E: Beeps and melodies Acoustic Signals All of the functions of the Accu-Chek Spirit Combo insulin pump Sound Function are supported by acoustic signals. The acoustic signals are beeps. DOWN KEY Frequency: 2486 Hz ±5 % Duration: Short sound...
Page 200 Sound Function Sound Function BASE STATE RUN (KEYS UNLOCKED) CARTRIDGE CONTENT <= 20 U Frequency: 2789 Hz ±5 % Frequency: f1 = 2090 Hz ±5 %, Duration: Short sound, short pause, f2 = 2486 Hz ±5 %, short sound, short pause, f3 = 2789 Hz ±5 % short sound Duration:...
Page 201 Sound Function Sound Function 50 U < CARTRIDGE CONTENT <= 100 U COPY BASAL RATE Frequency: f1 = 2090 Hz ±5 %, Frequency: 2486 Hz ±5 %, 3131 Hz ±5 %, f2 = 2486 Hz ±5 %, 2486 Hz ±5 % f3 = 2789 Hz ±5 % Duration: 3 ×...
Page 202 Sound Function Sound Function Reminder (REPEATING SEQUENCE) ERROR (REPEATING SEQUENCE) Frequency: f1 = 1043 Hz ±5 %, Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 % f2 = 1850 Hz ±5 % Duration: f1 medium sound, short Duration: f1 medium sound, short pause, f2 medium sound,...
Page 203 Sound Function Sound Function OK KEY PRESSED INITIAL POINT (SUBMENU, VALUE) Frequency: 2789 Hz ±5 % Frequency: 2820 Hz ±5 % Duration: Short sound Duration: Short sound, short pause, short sound CHANGED TO BASE STATE RUN BY OK KEY (KEYS UNLOCKED) SUPERVISOR SEQUENCE (GENERATED BY Sequence: A12, long pause, A14 SUPERVISOR)
Page 204 Tactile Signals Dedicated 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 Function Signal Function WARNING AND REMINDER SHORT VIBRATION Duration short vibration = (REPEATING SEQUENCE) Duration vibration = 1062.5 ms ±5 %...
Page 205: Appendix F: Symbols
Appendix F: Symbols Display Symbols Icon Meaning Icon Meaning Basal Lock OFF Bluetooth ® Basal Lock ON Bluetooth ® Settings Bluetooth ® in Remote control Basal Rate mode Basal Rate Total Beep Test Battery Empty Cartridge Empty Battery Low Cartridge Full Beep Volume Cartridge Low Bluetooth...
Page 206 Icon Meaning Icon Meaning Clock Key Lock ON Data Transfer menu Pump timer (Call for update) Data Transfer (to start screen) Menu Settings Data Transfer running Multiwave Bolus Date Multiwave Bolus Immediate Date Format EU My Data Date Format US Pairing Failed Display contrast Pairing Successful...
Page 207 Icon Meaning Icon Meaning Pump Settings Stop Reminder Total Reminder Everyday Temporary Basal Rate Reminder OFF Therapy Settings Reminder Settings Time and Date Settings Reminder Single Units Display orientation Units per hour Beep Vibrations Beep and Vibration Error Standard Bolus Warning man_05957613001_E_en.indb 203 02.03.2015 10:44:58...
Page 208 General Symbols Icon Meaning Icon Meaning Caution, refer to safety-related Use by notes in the instructions for use accompanying this product. Catalogue number Consult instructions for use Serial number Sterilized using ethylene oxide Global Trade Item Number Sterilized using irradiation Admissible temperature range Sterile using aseptic processing during operation...
Page 209 Icon Meaning Icon Meaning Do not use if the package is Fragile – handle with care! damaged Keep dry Flammable Keep away from sunlight Bluetooth ® wireless technology Electronic device of type BF Use only once according the standard IEC 60601-1. Protection against electrical shock.
Page 210 Icon Meaning Icon Meaning Marking of conformity according to The compliance mark indicates N20091 the European Medical Device that the product complies with the Directive MDD 93 / 42 / EEC with the applicable standard and estab- number of the notified body. lishes a traceable link between the equipment and the manufacturer, Marking of conformity according to...
Page 211: Appendix G: Warranty
Roche could void your operating warranty for the Accu-Chek Spirit Combo insulin pump. Please refer to the warranty provisions in your written terms of sale for the Accu-Chek Spirit Combo insulin pump and/or the applicable warranty regulations in your jurisdiction. man_05957613001_E_en.indb 207...
Page 212: Glossary
Basal rate profile of your Accu-Chek Spirit Combo insulin pump. The 2 small vents Your Accu-Chek Spirit Combo insulin pump offers you the option on the adapter allow the equalization air pressure.
Page 213 Cartridge compartment ® The term “Bluetooth” refers to a wireless technology that allows The chamber in your Accu-Chek Spirit Combo insulin pump for digital devices to transfer data at high speed. This technology is the cartridge. common in many portable devices such as portable PCs, Personal Daily insulin total Digital Assistants and mobile telephones.
Page 214 Infusion set IPX8 according to IEC 60529 Infusion sets connect your Accu-Chek Spirit Combo insulin pump Protection against the effects of temporary immersion in water. to your body. The insulin is delivered from the cartridge through the Ingress of water in quantities causing damage is not possible...
Page 215 When 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).
Page 216 STOP screen The 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 Rate Temporary increase or decrease of your basal rate profile in percentages (from 0 – 500 %) to match changing insulin needs due to increased or decreased activity level, illness or stress.
Page 217: Index
Index Bolus increment ........126 Abbreviations ........194 Buttons .
Page 218 Electromagnetic immunity ......183 Language Electromagnetic radiation ......62 selecting .
Page 219 Reminders Tactile signals ........200 list of .
Page 220 Warnings and Errors ....... 151 confirming ........152 handling .
Page 221: Quick Reference Table For Errors, Warnings And Reminders
Quick reference table for Errors, Warnings and Reminders Errors Error What you have to do Error What you have to do MECHANICAL ERROR See chapter 8. CARTRIDGE EMPTY Change the cartridge. ELECTRONIC ERROR See chapter 8. BATTERY EMPTY Change the battery. POWER INTERRUPT See chapter 8.
Page 222 Warnings Warning What you have to do Warning What you have to do CARTRIDGE LOW Change cartridge before it is TBR CANCELLED Put your Accu-Chek Spirit completely empty. Combo insulin pump into RUN if necessary. Ensure the cancella- BATTERY LOW Replace the battery as soon as tion was intended and program possible.
Page 223: Reminder
Reminder Warning What you have to do Reminder What you have to do LOANTIME WARNING In the MY DATA menu, check for Reminder Put your Accu-Chek Spirit the remaining insulin pump loan Combo insulin pump into RUN if time under the menu PUMP necessary.
Page 224: Bluetooth ® Registration
Bluetooth registration ® Please note that in Italy and France Bluetooth wireless Note: This equipment has been tested and found to comply with ® technology is for indoor use only. the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
Page 225 The compliance mark indicates that the product complies with India: ETA Certificate No: 468/2010/WRLO the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market.
Page 226: My Notes
My notes man_05957613001_E_en.indb 222 02.03.2015 10:45:07...

Roche ACCU-CHEK Spirit Combo User Manual

1 Understanding Your New System

2 Getting Started

3 Using Your Pump in Daily Life

4 Boluses and Temporary Basal Rates

5 Personalizing Your Pump

6 Using the Accu-Chek Spirit Combo Insulin Pump with the Meter

7 Care and Maintenance

8 Warnings and Errors

9 Troubleshooting

Appendix A: Technical Data

Appendix B: Configuration Parameters

Appendix C: Sterile Products and Accessories

Appendix D: Abbreviations

Appendix E: Beeps and Melodies

Appendix F: Symbols

Appendix G: Warranty

Quick Links

Troubleshooting

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Summary of Contents for Roche ACCU-CHEK Spirit Combo

Table of Contents