Accu-Chek Spirit User Manual
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Accu-Chek Spirit User Manual

Insulin pump
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INSULIN PUMP
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Summary of Contents for Accu-Chek Spirit

  • Page 1 INSULIN PUMP User Guide...
  • Page 2 The Accu-Chek Spirit – At a Glance Display Menu key Up key Down key Check key Infusion set Adapter Cartridge This user’s guide is valid for version 2.XX of the Accu-Chek Spirit.
  • Page 3 Dear Accu-Chek Spirit insulin pump user, Congratulations on your new Accu-Chek Spirit insulin pump. You and your Accu-Chek Spirit insulin pump are unique. Therefore, it is important that you, your doctor or healthcare team fill in the following information: Serial number of your Accu-Chek Spirit insulin pump...
  • Page 4 Your contact for assistance with and/or additional information about your Accu-Chek Spirit insulin pump: United Kingdom: New Zealand: Roche Diagnostics Ltd. Roche Diagnostics N.Z. Ltd. Charles Avenue P.O. Box 62-089 Burgess Hill 15 Rakino Way West Sussex, RH15 9 RY Mt.

  • Page 5: Table Of Contents

    2.2 Guarantee ......... 23 3 The Accu-Chek Spirit insulin pump ......25 3.1 Display .
  • Page 6 6 Select a user menu (STANDARD, ADVANCED or CUSTOM) ..75 6.1 The three levels of the Accu-Chek Spirit ....75 6.2 Navigate through the menus .
  • Page 7 Content 7.6 Temporary basal rate (TBR)......102 7.6.1 Program a temporary basal rate ....103 7.6.2 Cancel a temporary basal rate .
  • Page 8 11 Troubleshooting ........165 12 Life with your Accu-Chek Spirit insulin pump ....169 12.1 Recommendations for daily use .
  • Page 9 13.3 Travelling ........176 14 Care of your Accu-Chek Spirit insulin pump ....177 14.1 System check .

  • Page 11: Introduction

    This user guide is written for you as well as for healthcare professionals. It is designed to provide you with the necessary information for safe and efficient use of your Accu-Chek Spirit insulin pump. Regardless of your experience with pump therapy, please read this user guide carefully before using your Accu-Chek Spirit insulin pump.

  • Page 12: How To Use This User Guide

    We also recommend that you have someone around you (e.g. family, friends) who understands diabetes and pump therapy with your Accu-Chek Spirit insulin pump to help you in case of an emergency. Should you have any questions, we urge you to contact your local Customer Care Area, your doctor or healthcare team.

  • Page 13: Intended Use Of Your Accu-Chek Spirit Insulin Pump

    1.4 Intended use of your Accu-Chek Spirit insulin pump Your Accu-Chek Spirit insulin pump is a prescription device and has been developed exclusively for the continuous subcutaneous delivery of U100 short-acting insulin or fast-acting insulin analogue. The insulin type for the treatment of your insulin dependent diabetes mellitus will be prescribed by your doctor or healthcare team.

  • Page 15: Before You Begin

    Record your personal settings from your current insulin pump and ensure that they are correctly programmed into a new Accu-Chek Spirit insulin pump. Make sure that the time and date are set correctly. If you are not sure about your personal settings or you are less experienced, contact your doctor or healthcare team to check your personal settings.
  • Page 16 Before you begin determine the timing as well as the amount and type of bolus you need to deliver. Make sure you know your personal carbohydrate insulin ratio and your correction bolus ratio. ➨ When your insulin pump is in STOP, it does not deliver any insulin.

  • Page 17: Warnings And Cautions Regarding Hygiene

    Before you begin 2.1.2 Warnings and cautions regarding hygiene ➨ Your insulin pump was designed to use an Accu-Chek 3.15 ml plastic cartridge. The cartridge is a sterile product intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiration date. Do not use sterile products if the package is damaged.

  • Page 18: Warnings And Cautions On Proper Use

    Before you begin ➨ Always have extra sterile products and accessories with you. This allows you to exchange components when needed. Materials designed for single use (such as cartridges and infusion sets) may not be reused due to the increased risk of infections, malfunctions and/or incorrect insulin delivery.
  • Page 19 ➨ Do not use the Accu-Chek Spirit insulin pump if you are not able to read the display, hear the beeps or you are not able to feel the vibrations. The display, beeps and vibrations indicate critical alert information and must be addressed immediately by the insulin pump user.

  • Page 20: Warnings And Cautions For Secure Use

    ➨ Do not use any adapter from another insulin pump (e.g. H-TRON / H-TRONplus adapters) for your Accu-Chek Spirit. ➨ If an error E4: OCCLUSION occurs, immediately check your blood glucose level, because insulin delivery has been interrupted.
  • Page 21 Before you begin ➨ Cold insulin may release air when warmed. Use only insulin at room temperature when filling the cartridge and priming the infusion set. Inspect the cartridge and the infusion set for air bubbles at least every three hours during the day and before you go to sleep.

  • Page 22: Warnings And Cautions About Environmental Hazards

    Before you begin ➨ If the piston rod does not return completely to its base after the cartridge has been removed, immediately contact your local Customer Care Area for support. ➨ After the occurrence of an error, your insulin pump will be in STOP and the insulin delivery is interrupted.

  • Page 23: Warnings And Cautions Regarding Safe Battery Use

    ➨ Your insulin pump has not been tested with other electronic medical devices. Therefore, do not use the Accu-Chek Spirit insulin pump with another electronic medical device unless advised by your doctor or healthcare team.

  • Page 24: Warnings And Cautions About Wearing

    ➨ Change the battery in a dry environment. Tighten or loosen the battery cover with the Accu-Chek Spirit battery key (sharp objects could damage the insulin pump). Do not over-tighten. Over-tighten- ing may cause damage to the battery cover and to the insulin pump casing.

  • Page 25: Guarantee

    If you have any additional questions about these warnings and cautions please feel free to contact your local Customer Care Area. 2.2 Guarantee ➨ Any changes or modification to the devices not expressly approved by Roche Diagnostics could void your operating warranty for the Accu-Chek Spirit insulin pump.

  • Page 27: The Accu-Chek Spirit Insulin Pump

    The Accu-Chek Spirit insulin pump 3 The Accu-Chek Spirit insulin pump Caution Check your insulin pump and its sterile products and accessories for chips and cracks at least once per day, especially if they have been dropped. Do not use them if chipped or cracked.

  • Page 28: Backlight

    The Accu-Chek Spirit insulin pump 3.2 Backlight The backlight helps you use your insulin pump or read the information in poorly lighted areas. You can turn on the backlight from the RUN screen, STOP screen or when browsing the menus, by pressing a.
  • Page 29 The Accu-Chek Spirit insulin pump The use of your insulin pump requires the use of four keys and three key combinations. Each key or key combination has a specific function: Name Function Menu move through menus, function and information screens...
  • Page 30 The Accu-Chek Spirit insulin pump A plus symbol (+) connecting 2 key functions means that both keys must be pressed simultaneously: Combination Name Function Menu and Up Exit a menu or function and information screens. Loop backward in the menu structure.

  • Page 31: Keylock

    The Accu-Chek Spirit insulin pump Symbol Timeout g For your safety and convenience during programming, your insulin pump automatically returns to the RUN or STOP screen if no key is pressed within 20 seconds h. For your safety, the changes you made before your insulin pump “times out”...

  • Page 32: Scrolling

    The Accu-Chek Spirit insulin pump 3.5 Scrolling In order to enter larger or smaller values, the a or s key must normally be pressed many times with small increments per press. However, in most menus, you can hold the a or s key (scrolling) until the desired number is displayed.

  • Page 33: Status Screen

    The Accu-Chek Spirit insulin pump 3.6 STATUS screen Beeps, vibrations and messages on the display inform you of the status of your insulin pump. Your insulin pump beeps when a key is pressed, regardless of how the alarm signals are set. You can turn off either the beeps or the vibrations as alarm signals, but not both at the same time.

  • Page 34: Run And Stop Modes

    The Accu-Chek Spirit insulin pump 3.8 RUN and STOP modes During normal use, your insulin pump is in RUN and insulin is delivered (basal rate) at the rate you have programmed. The RUN screen is consid- ered the “home” screen and will be displayed whenever the pump is in RUN.

  • Page 35: Stop-Warning

    The Accu-Chek Spirit insulin pump time date KeyLock unlocked pump timer cartridge low battery low 3.9 STOP-Warning The STOP-Warning is turned on each time your pump is changed from RUN into STOP or when a battery is inserted. This reminder is to inform you that insulin delivery is currently interrupted.

  • Page 37: Accessories, Disposables And Software

    Accessories, disposables and software 4 Accessories, disposables and software Accu-Chek sterile products, accessories and software complete your Accu-Chek Spirit insulin pump system. They are specially designed for safe and convenient insulin pump therapy. Caution Only use sterile products and accessories that are designed for use with your insulin pump.

  • Page 38: Sterile Products

    4.1 Sterile products Accu-Chek sterile products are a critical part of your Accu-Chek Spirit insulin pump system and therapy. Sterile products are designed for single use only to enable proper function of your Accu-Chek Spirit insulin pump and to avoid infections.

  • Page 39: Cartridge

    Accessories, disposables and software 4.1.1 Cartridge Your insulin pump was designed to use an Accu-Chek 3.15 ml plastic cartridge. The cartridge is a sterile product intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiration date.

  • Page 40: Infusion Sets

    Accessories, disposables and software 4.1.2 Infusion sets The Accu-Chek infusion sets connect your insulin pump to your body and are a crucial part of your insulin pump therapy. The insulin is delivered from the cartridge in your insulin pump through the infusion set into your subcutaneous tissue.

  • Page 41: Adapter

    Accessories, disposables and software Roche Diagnostics offers a wide range of infusion sets: Common lengths of the tubing Filling volume with U100 insulin 30 cm / 12" 7 units 60 cm / 24" 10 units 80 cm / 31" 13 units 110 cm / 43"...

  • Page 42: Battery

    Accessories, disposables and software 4.3 Battery Your insulin pump has been designed for use with AA ALKALINE batteries with a minimum capacity of 2500 mAh. Do not use lithium, carbon zinc or nickel cadmium (NiCd) batteries. If you prefer rechargeable batteries, Roche Diagnostics recommends NiMH batteries with a minimum capacity of 1500 mAh.

  • Page 43: Battery Cover

    • Make sure that the seal is not worn out or missing and that the battery is properly inserted into your insulin pump. • Tighten or loosen the battery cover only with the Accu-Chek Spirit battery key (using knives, screwdrivers or other sharp objects may harm your insulin pump).

  • Page 44: Battery Key

    The battery key has a notch that fits the luer-lock connectors of the Accu-Chek FlexLink and the Accu-Chek TenderLink infusion sets. Never use the battery key to attach...

  • Page 45: Emergency Kit

    • A pen or syringe for alternate therapy • A vial of insulin • Treatment for low blood glucose levels • Blood glucose monitoring supplies (such as an Accu-Chek blood glucose monitor) • A disinfectant for skin • A new site dressing • The battery key The above list is only an example of what this emergency kit should contain.

  • Page 46: Software

    4.7 Software The Accu-Chek Insulin Pump Configuration Software is an optional insulin pump programming tool for the Accu-Chek Spirit insulin pump*. This software allows for fast and easy change of parameters and settings directly from your Microsoft Windows compatible PC.

  • Page 47: Preparing The Pump For Use

    Prepare the pump for use 5 Prepare the pump for use This section will show you how to get your pump up and running. 5.1 Insert and change the battery Your insulin pump turns on as soon as you insert the battery. When you remove the battery, your insulin pump keeps track of the time and date for approximately 1 hour.
  • Page 48 Tighten or loosen the battery cover with the Accu-Chek Spirit battery key (use of knives, screwdrivers or other sharp objects may harm your insulin pump). Do not over-tighten as this may cause damage to the battery cover and to the casing.
  • Page 49 Prepare the pump for use Remove the battery cover from your insulin pump. Use the battery key to turn the battery cover counter-clockwise as indicated by the arrow on the battery cover. Make sure the opening of the battery compartment and the seal are clean and undamaged.

  • Page 50: Start-Up Procedure

    When you remove the battery your insulin pump remembers the settings you made and saved. If your Accu-Chek Spirit insulin pump remains without a battery for more than one hour, check the time and date upon reinsertion of a battery.
  • Page 51 (warning instruction) or an error (error message) occurs. The software version (SW VERSION) of your insulin pump appears on the display. The Accu-Chek logo appears. SELF-TEST appears. Your insulin pump beeps and BEEP TEST appears.
  • Page 52 Prepare the pump for use Caution If you cannot hear the beeps your insulin pump needs to be returned since you may not be notified of any changes of your insulin pump in a suitable amount of time. Contact your local Customer Care Area. Your insulin pump vibrates and VIBRATION TEST appears.
  • Page 53 Contact your local Customer Care Area. Additionally, you will see an information screen. This data can be modified by you or your physician with the Accu-Chek Insulin Pump Configuration Software. Please see the Accu-Chek Insulin Pump Configuration Software user manual for additional information.

  • Page 54: Prepare The Cartridge

    Prepare the pump for use 5.2.1 Prepare the cartridge Warning Your insulin pump was designed to use an Accu-Chek 3.15 ml plastic cartridge. The cartridge is a sterile product intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiration date.
  • Page 55 Prepare the pump for use A cartridge set consists of the following items: 1. 3.15 ml plastic cartridge with protective cap, plunger rod and filling needle. cartridge plunger rod plunger cartridge protective cap filling needle with protective cap 2. Instructions for use...

  • Page 56: Fill The Cartridge

    Prepare the pump for use 5.2.2 Fill the cartridge A filling aid by Roche Diagnostics can be used to help you fill an empty 3.15 ml plastic cartridge from your vial of insulin. For detailed instructions for using a filling aid consult the instructions included with that item. To fill a cartridge, have the following materials ready: New 3.15 ml plastic cartridge with protective cap, plunger rod and filling needle...
  • Page 57 Prepare the pump for use Place the filling needle with protective cap onto the cartridge tip and make sure the connection is tight. Move the plunger rod twice back and forth in the cartridge to distribute the lubricant. Pull the plunger back to fill the cartridge with air.
  • Page 58 Prepare the pump for use While holding steady pressure against the plunger rod with your thumb, invert the insulin vial so that the filling needle and cartridge are pointing upwards into the insulin vial. Make sure that the tip of the filling needle stays in the insulin.
  • Page 59 Prepare the pump for use Place the protective cap onto the filling needle. Remove the plunger rod by turning it clockwise out of the plunger. Remove the filling needle with its protective cap from the cartridge by turning counter-clockwise. Push the cartridge protective cap tightly onto the cartridge tip until it clicks.

  • Page 60: Insert The Cartridge, Adapter And Infusion Set

    5.3.1 Connect the cartridge, adapter and infusion set Have the following materials ready: A filled Accu-Chek 3.15 ml plastic cartridge with a luer connection An Accu-Chek Spirit adapter A new Accu-Chek infusion set...
  • Page 61 Push the adapter onto the cartridge tip as far as to the stop (a). Luer-lock connector Carefully prepare a new Accu-Chek infusion set for use. Hold the adapter and twist the infusion set by hand clockwise into the adapter (b).

  • Page 62: Insert The Cartridge

    Prepare the pump for use Caution To avoid leakage, properly tighten the infusion set to the adapter. Turn the luer-lock connector only as far as to the stop. Do not turn it any further and do not use any auxiliary tools as this may crack the infusion set luer-lock connector and result in leakage.
  • Page 63 Have the following materials ready: Your Accu-Chek Spirit insulin pump A filled 3.15 ml plastic cartridge with a connected Accu-Chek Spirit adapter and a new Accu-Chek infusion set. Make sure your insulin pump is in STOP. Press d to move to the CHANGE THE CARTRIDGE menu.
  • Page 64 Prepare the pump for use When the piston rod has returned completely, the CARTRIDGE VOLUME screen displays the maximum cartridge volume (315 U). Hold your insulin pump upright. Hold the new filled cartridge with connected adapter and infusion set pointing upwards and hold them parallel and close to the cartridge compartment.
  • Page 65 Prepare the pump for use Press or scroll a or s to move the piston rod forward until the base plate of the piston rod and the cartridge plunger are level. The displayed cartridge volume decreases accordingly. Re-insert the cartridge into the cartridge compartment.

  • Page 66: Prime The Infusion Set

    Prepare the pump for use 5.4 Prime the infusion set Warning Never prime an infusion set that is connected to your body. You risk uncontrolled insulin delivery into your body. With disconnectable infusion sets, make sure you have disconnected the tubing from your site prior to priming.
  • Page 67 Prepare the pump for use start-up procedure 3 sec. STOP prime the start stop screen infusion set priming priming Make sure your insulin pump is in STOP. Press d to move to the PRIME THE INFUSION SET menu. Select with f. START PRIMING and the priming amount of 25 units h of insulin is shown on the display.

  • Page 68: Prepare The Infusion Site

    Prepare the pump for use Stop priming The priming process can be stopped at any time by pressing any key. Your insulin pump returns to the STOP screen. 5.5 Prepare the infusion site Always follow the instructions given by your doctor or healthcare team and the instructions for use of the infusion set you are using.
  • Page 69 Prepare the pump for use Have the following materials ready: Your Accu-Chek Spirit insulin pump with filled cartridge, connected Accu-Chek Spirit adapter and a new primed infusion set A disinfectant for skin Wash your hands thoroughly. Desinfect the infusion site and let it dry completely.
  • Page 70 Prepare the pump for use Note If you use a soft cannula-type infusion set, you must bolus to fill the air space in the cannula after removing the introducer needle and connecting the tubing according to the instructions for the infusion set you are using. Failure to do so could result in missed insulin dosing.

  • Page 71: Change The Infusion Set

    Prepare the pump for use 5.6 Change the infusion set When changing the infusion set, please keep the following points clearly in mind: Infusion sets are sterile products intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiration date.
  • Page 72 Note The battery key has a notch that fits the luer-lock connectors of the Accu-Chek FlexLink and the Accu-Chek TenderLink infusion sets. You may use the battery key to loosen the luer-lock connector between your infusion set and adapter if it cannot be loosened by hand.

  • Page 73: Change The Cartridge And Infusion Set

    Note The battery key has a notch that fits the luer-lock connectors of the Accu-Chek FlexLink and the Accu-Chek TenderLink infusion sets. You may use the battery key to loosen the luer-lock connector between your infusion set and adapter if...
  • Page 74 Prepare the pump for use a. Hold your Accu-Chek Spirit with the adapter pointing downwards, to prevent the remaining insulin from flowing into the cartridge compartment. b. Remove the adapter and cartridge from your insulin pump by unscrewing the adapter from the insulin pump casing.

  • Page 75: Change The Adapter

    Specially designed carrying systems allow you to carry your insulin pump on or underneath your clothes. All specified accessories have been tested and approved for use with your Accu-Chek Spirit insulin pump. The proper functionality of your insulin pump can only be guaranteed in conjunction with Accu-Chek Spirit accessories.

  • Page 77: Select A User Menu (Standard, Advanced Or Custom)

    Select a user menu (STANDARD, ADVANCED or CUSTOM) 6 Select a user menu (STANDARD, ADVANCED or CUSTOM) 6.1 The three levels of the Accu-Chek Spirit The operation of your insulin pump is divided into three levels. level level level RUN screen and...

  • Page 78: Navigate Through The Menus

    Select a user menu (STANDARD, ADVANCED or CUSTOM) 6.2 Navigate through the menus level level level (3.) (2.) (4.) menu function screen screen (1.) backward looping function loop screen (5.) exit timeout menu looping 1. Press d to move to the menus (2 level).

  • Page 79: Scrolling

    Select a user menu (STANDARD, ADVANCED or CUSTOM) 6.2.1 Scrolling You can hold a or s pressed to enter larger or smaller values until the desired number is displayed. This value can be corrected by single key presses up or down if necessary. 6.2.2 Looping The menus and screens are set up in a “loop”...

  • Page 80: Select A User Menu

    6.2.5 Select a user menu A user menu comprises a fixed or an individually composed selection of the Accu-Chek Spirit menus. Your insulin pump offers a choice of 3 different user menus: Note In the flap at the end of this user guide you will find diagrams for the STANDARD and ADVANCED user menus.
  • Page 81 Select a user menu (STANDARD, ADVANCED or CUSTOM) For your personalized CUSTOM user menu you can turn the following menus on or off by using Accu-Chek Insulin Pump Configuration Software: – EXTENDED BOLUS – MULTIWAVE BOLUS – TEMPORARY BASAL RATE (TBR) –...
  • Page 82 Select a user menu (STANDARD, ADVANCED or CUSTOM) select the user select basal screen user menu menu rate profile Press d to move to the SELECT USER MENU. Select with f. The current user menu is displayed. Note If the SELECT USER MENU is not available, contact your doctor or healthcare team.
  • Page 83 Select a user menu (STANDARD, ADVANCED or CUSTOM) Check the (new) basal rate profile and its daily insulin total. Save and exit with f. The new user menu and basal rate profile are active immediately. Caution A running temporary basal rate increase or decrease will remain active, even if you changed the basal rate profile.

  • Page 85: Standard User Menu

    7 STANDARD user menu This chapter will familiarize you with the basic functions of your Accu-Chek Spirit insulin pump that are necessary for a successful therapy. 7.1 Set time and date You must take care to set the time and date correctly, because the basal rates and all history information are stored on the basis of time and date.
  • Page 86 (such as an Accu-Chek Blood Glucose Meter), PC and other used devices, are set identically. If they are not, the gathered data might not be meaningful.
  • Page 87 STANDARD user menu Set time and date set the time set the screen and date hour set the minute set the year set the month set the Press d to move to the SET TIME AND DATE menu. Select with f. Press a or s to set the hour.
  • Page 88 STANDARD user menu Press d to move to the month. Press a or s to set the month. Press d to move to the day. Press a or s to set the day. Save and exit with f. Note At any screen you have three options to exit: if you want to confirm and save the changes –...

  • Page 89: Basal Rate

    (U/h), is called the basal rate and is calculated to meet your basic insulin needs. An Accu-Chek Spirit basal rate profile consists of up to 24 different hourly basal rates. Each hourly rate may be changed independently. The sum of all 24 hourly basal rates in one basal rate profile is called the (daily) basal rate total.

  • Page 90: Program A Basal Rate Profile

    STANDARD user menu 7.2.1 Program a basal rate profile program daily basal screen profile 1 rate total 1st hour 2nd hour … 24th hour Press d to move to the PROGRAM BASAL RATE PROFILE 1 menu. Select with f. The daily BASAL RATE TOTAL is displayed. Press d to move to the first hour.
  • Page 91 STANDARD user menu Press d to move to the next hour. Continue using d and the a and s keys to set the hourly basal rates for the remaining hours. In this way you can program your individ- ual basal rate profile hour-by-hour. Continue until all 24 hours are programmed.

  • Page 92: Copy An Hourly Basal Rate

    STANDARD user menu 7.2.2 Copy an hourly basal rate An hourly basal rate can be copied for 1 or more hours. Press d to move to the PROGRAM BASAL RATE PROFILE 1 menu. Select with f. The daily BASAL RATE TOTAL is displayed. Press d to move to the hourly basal rate which you want to copy.

  • Page 93: Basal Rate And Bolus

    STANDARD user menu 7.2.3 Basal rate and bolus – During normal use, your insulin pump is in RUN and insulin is continuously delivered (basal rate). – A bolus can be programmed when needed. Unless you are currently changing settings, giving a bolus or reviewing informa- tion, the RUN screen is displayed.

  • Page 94: Start Insulin Delivery

    Insulin delivery starts at the moment you put your insulin pump into RUN. Start from the STOP screen. Press d to move to the START YOUR ACCU-CHEK menu. Confirm with f. Your insulin pump shows the RUN screen. Insulin delivery begins within the next 3 minutes at the hourly basal rate shown on the display.

  • Page 95: Stop Insulin Delivery

    • connecting and disconnecting the adapter and/or infusion set • priming the infusion set and • data transfer from the insulin pump to the PC and vice versa using Accu-Chek Insulin Pump Configuration Software. Caution When your insulin pump is in STOP, it does not deliver any insulin.
  • Page 96 STANDARD user menu Note When an Extended bolus, a MultiWave bolus and/or a tempo- rary basal rate (TBR) is/are active and you put your insulin pump into STOP, an alert A6: TBR CANCELLED and/or an alert A8: BOLUS CANCELLED occur(s). Press f twice for each appearing alert to confirm and turn off.

  • Page 97: Program A Bolus

    STANDARD user menu 7.5 Program a bolus 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, amount and type of bolus you need to deliver with your doctor or healthcare team.

  • Page 98: Standard Bolus

    STANDARD user menu 7.5.1 Standard bolus Your insulin pump offers you two possibilities to program a Standard bolus: “Quick” Standard bolus “Scroll” Standard bolus Using the keys of your Menu-guided using the insulin pump, with bolus increments keys with the keys for determined by the user.

  • Page 99: Program A "Quick" Standard Bolus

    The bolus increment for the “Quick” Standard bolus is initially set to 0.5 units h. It can be changed in the SETUP MENU ADVANCED or by using Accu-Chek Insulin Pump Configuration Software. 3 sec.
  • Page 100 STANDARD user menu Note We recommend starting with the s key in areas of good lighting and, starting with the a key in areas of poor lighting as this will also turn on the backlight. Press a (s) repeatedly until the desired bolus amount is reached.

  • Page 101: Cancel A "Quick" Standard Bolus

    STANDARD user menu 7.5.3 Cancel a “Quick” Standard bolus – During programming (the bolus amount blinks): • Press the key you started programming with (s [a]) to reset the bolus amount to 0.0 units. You hear a melody. If no new bolus is programmed, your insulin pump returns to the RUN screen and beeps three times after 5 seconds h.

  • Page 102: Program A Menu-Guided "Scroll" Standard Bolus

    STANDARD user menu 7.5.4 Program a menu-guided “Scroll” Standard bolus The bolus increments for the “Scroll” Standard bolus are fixed to 0.1 unit. You can program this bolus in the STANDARD BOLUS menu by holding the a or s key (scrolling) until the desired bolus amount is displayed. Press d to move to the STANDARD BOLUS menu.

  • Page 103: Cancel A Menu-Guided "Scroll" Standard Bolus

    STANDARD user menu 7.5.5 Cancel a menu-guided “Scroll” Standard bolus – During programming (the bolus amount blinks): You have three options for cancelling a “Scroll” Standard bolus during programming: • If you do not press any key for 20 seconds h, your insulin pump returns to the RUN screen (timeout).

  • Page 104: Temporary Basal Rate (Tbr)

    STANDARD user menu 7.6 Temporary basal rate (TBR) Your insulin pump allows you to temporarily increase or decrease your basal rate. This function is helpful in matching changing insulin needs due to increased or decreased activity level, illness or stress. Warning Incorrect programming of your insulin pump may cause inappropriate insulin delivery.

  • Page 105: Program A Temporary Basal Rate

    STANDARD user menu 7.6.1 Program a temporary basal rate temporary precentage screen basal rate duration Make sure your insulin pump is in RUN. Press d to move to the TEMPORARY BASAL RATE (TBR) menu. Select with f. The TBR PERCENTAGE screen appears.
  • Page 106 STANDARD user menu Press d to move to the TBR DURATION. Press a or s to correct and set the duration. Note Press d to loop between programming the basal rate percentage and duration, if necessary. Save and exit with f. The programmed temporary basal rate is immediately activated.

  • Page 107: Cancel A Temporary Basal Rate

    STANDARD user menu At the end of a temporary basal rate, an alert A7: TBR OVER occurs h. Press f twice to confirm and turn off the alert. See the section 10.1.7 “Alert A7: TBR OVER” for further information. 7.6.2 Cancel a temporary basal rate –...
  • Page 108 STANDARD user menu • Put your insulin pump into STOP. The temporary basal rate delivery is interrupted. An alert A6: TBR CANCELLED occurs. Press f twice to confirm and turn off the alert. See the section 10.1.6 “Alert A6: TBR CANCELLED” for further information.

  • Page 109: Setup Menu Standard

    For all SETUP MENU STANDARD settings the Accu-Chek Spirit can save or exit using the same simple method. For all of the features in this section you may do the following when you are finished with a section: if you want to confirm and save the changes –...
  • Page 110 STANDARD user menu RUN / STOP setup KeyLock screen standard beep volume alarm signals automatic off battery type o rientation Turn the KeyLock on or off Make sure the KeyLock is unlocked (press and hold d + s simultaneously for 3 seconds until it is unlocked) or turned off.

  • Page 111: Adjust The Beep Volume

    STANDARD user menu Unlock the KeyLock 3 sec. RUN screen locked 10 sec. RUN screen unlocked From the RUN screen or STOP screen, press d + s simultaneously (you hear three beeps in RUN, respectively one beep in STOP) and hold for 3 seconds until you hear again three beeps (in RUN), respectively one beep (in STOP) to confirm that the KeyLock has been unlocked.

  • Page 112: Alarm Signals

    These beeps will steadily increase in volume until the maximum level occurs if the alert or error is not cancelled. 7.7.3 Alarm signals The Accu-Chek Spirit allows you to choose how you want your pump to alert you when an alarm occurs. You have three options: beep only...

  • Page 113: Automatic Off

    STANDARD user menu Press d to move to the ALARM SIGNALS screen. The active alarm signals are displayed. Press a or s to set the alarm signals as desired. Save and exit with f. 7.7.4 Automatic off Caution Discuss the use of the automatic off function with your doctor or healthcare team.

  • Page 114: Battery Type

    STANDARD user menu 7.7.5 Battery type Warning If you do not set the correct battery type on your insulin pump, the alert A2: BATTERY LOW may not occur in time to provide you sufficient warning to replace your battery. Your insulin pump has the option of using 1.5 volt AA Alkaline batteries or rechargeable AA NiMH batteries.

  • Page 115: Display Orientation

    STANDARD user menu 7.7.6 Display orientation Your insulin pump allows you to flip the display orientation by 180 ° so that you can view it more conveniently depending on how you are wearing the insulin pump. Press d to move to the SETUP MENU STANDARD.

  • Page 116: Review Data Memory (Information)

    4500 events. This data memory corresponds typically to about the last 90 days of usage and is accessible via Accu-Chek information management products. The following data can be reviewed directly on your insulin pump: •...
  • Page 117 STANDARD user menu information bolus screen menu history alarm history daily total TBR history Press d to move to the INFORMATION menu. Select with f. The BOLUS HISTORY screen appears. The most recent bolus information is displayed. Press a or s to review the entries. Exit with f.

  • Page 118: Review The Alarm History

    STANDARD user menu 7.8.2 Review the alarm history The alarm history enables you to review the last 30 alerts or errors starting with the most recent entry in chronological order. Each alarm history screen displays the • number and type of the alert or error (e.g. A6), •...

  • Page 119: Review The Temporary Basal Rate History

    STANDARD user menu Press d to move to the INFORMATION menu. Select with f. Press d to move to the DAILY TOTALS screen. Press or scroll a or s to review the entries. Exit with f. 7.8.4 Review the temporary basal rate history The temporary basal rate history enables you to review the last 30 TBR increases or decreases starting with the most recent entry in chronological order.

  • Page 120: Review The Time Remaining

    This timer counts the number of days of operation remaining in the Accu-Chek Spirit insulin pump. Before the pump timer expires, an alert occurs to remind you of the upcoming end of operating time so that you can make the necessary arrangements.

  • Page 121: Quick Info Screen

    STANDARD user menu 7.8.6 Quick info screen With the press of the f key, your insulin pump will display the remaining cartridge content in units and the insulin concentration. Symbols for activated functions and features (like the beep and vibration alarm signals) are displayed. To get to the quick info screen Press f from the RUN screen or STOP screen.

  • Page 123: Advanced User Menu

    The ADVANCED user menu activates all of the therapy options you have with your pump. The Accu-Chek Spirit insulin pump allows you to choose the menus that you wish to view. This allows you to adjust your pump’s features to better fit your level of diabetes management.

  • Page 124: Extended Bolus

    ADVANCED user menu Warning Incorrect programming of your insulin pump may cause inappropriate insulin delivery. Your insulin pump must be programmed with your personal settings prior to starting insulin pump therapy. Do not operate your insulin pump without knowing your personal settings. If you are not sure about your personal settings or you are less experienced, have your doctor or healthcare team check your personal settings.

  • Page 125: Program An Extended Bolus

    ACCU-CHEK A8: bolus cancelled Press d to move to the EXTENDED BOLUS menu. Select with f. The BOLUS AMOUNT screen appears. Press a to increase or s to decrease the bolus amount.

  • Page 126: Cancel An Extended Bolus

    ADVANCED user menu Press f to confirm the bolus amount and duration. You hear a melody and the bolus delivery begins within the next 3 minutes. Note During the entire bolus delivery, the remaining time and amount of the Extended bolus and the current hourly basal rate are displayed in the RUN screen.
  • Page 127 ADVANCED user menu – During bolus delivery: • If the Extended bolus delivery has begun, it can be cancelled by putting your insulin pump into STOP. This cancels the bolus delivery and an alert A8: BOLUS CANCELLED occurs. Press f twice to confirm and turn off the alert.

  • Page 128: Multiwave Bolus

    ADVANCED user menu 8.2 MultiWave bolus The MultiWave bolus is only available in the ADVANCED user menu and depending on your personal settings in the CUSTOM user menu. It is designed to better simulate a body’s insulin delivery. It combines an immediate bolus delivery followed by an Extended bolus delivery.

  • Page 129: Program A Multiwave Bolus

    3 sec. delivery immediate bolus stop your Accu-Chek bolus duration 5 sec. delay A8: bolus cancelled Press d to move to the MULTIWAVE BOLUS menu. Select with f. The BOLUS AMOUNT screen appears. Press a to increase or s to decrease the total bolus amount.
  • Page 130 ADVANCED user menu Press d to move to the IMMEDIATE BOLUS amount. Press a or s to correct and set the immediate bolus amount. Press d to move to the BOLUS DURATION. Press a or s to correct and set the Extended bolus duration in increments of 15 minutes h up to 12 hours h.

  • Page 131: Cancel A Multiwave Bolus

    No bolus is delivered. – During the start delay ( blinks): • Press s or a. Your Accu-Chek Spirit beeps and vibrates. Your insulin pump returns to the RUN screen. An alert A8: BOLUS CANCELLED occurs. Press f twice to confirm and turn off the alert.
  • Page 132 ADVANCED user menu Note If the alert A8: BOLUS CANCELLED does not occur, the bolus delivery was not cancelled. Cancel the extended delivery (see below). • The extended delivery can be cancelled by putting your insulin pump into STOP. This cancels the Extended bolus. An alert A8: BOLUS CANCELLED occurs.

  • Page 133: Basal Rate Profiles

    If you and your doctor or healthcare team decide that additional basal rate profiles are not necessary you may hide basal rate profiles 2 to 5 in the CUSTOM user menu using Accu-Chek Insulin Pump Configuration Software Pro for healthcare professionals (see the Accu-Chek Insulin Pump Configuration Software user manual for additional information).

  • Page 134: Select A Basal Rate Profile

    ADVANCED user menu 8.3.2 Select a basal rate profile change the BR profile screen BR profile no. … Make sure the CHANGE BASAL RATE PROFILE menu is turned on. Press d to move to the CHANGE BASAL RATE PROFILE menu. Select with f.

  • Page 135: Alarm Clock

    Note When you change the user menu your current basal rate profile might not appear. Make sure that your desired basal rate profile numbers are activated with Accu-Chek Insulin Pump Configuration Software. Should your desired basal rate profile number(s) not appear, –...

  • Page 136: Setup Menu Advanced

    ADVANCED user menu Press a or s to set the alarm clock to OFF ( ), to a single alarm ( ) or to every day ( ). Press d to move to the SET ALARM HOUR screen. Press a or s to set the hour. Press d to move to the SET ALARM MINUTE screen.

  • Page 137: Date Format

    ADVANCED user menu Make sure the SETUP MENU ADVANCED is turned on. Press d to move to the SETUP MENU ADVANCED. Select with f. The TIME FORMAT screen appears. Press a or s to select the desired time format. Save and exit with f. 8.5.2 Date format The date can be set in the following formats: European:...

  • Page 138: Bolus Increment

    To address patients that may need large or small amounts of insulin, the bolus increment for the Accu-Chek Spirit is adjustable. The “Quick” Standard bolus is initially set to 0.5 units h per key press but can be changed in the SETUP MENU ADVANCED or by using Accu-Chek Insulin Pump Configuration Software to 0.1, 0.2, 0.5, 1.0 or 2.0 units.

  • Page 139: Prime Quantity

    ADVANCED user menu 8.5.4 Prime quantity The prime quantity necessary to completely fill 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 quantity is 25 h units of insulin.

  • Page 140: Lock Basal Rate Profiles

    ADVANCED user menu 8.5.5 Lock basal rate profiles Your insulin pump allows you to change your hourly basal rates as needed. This feature provides additional protection against accidentally changing a basal rate during normal operation. When this function is activated, your hourly basal rates cannot be changed. Make sure the SETUP MENU ADVANCED is turned on.

  • Page 141: Language

    ADVANCED user menu 8.5.6 Language Your insulin pump is programmed in several languages. To use the language of your choice, do the following: Make sure the SETUP MENU ADVANCED is turned on. Press d to move to SETUP MENU ADVANCED. Select with f.

  • Page 142: Display Contrast

    ADVANCED user menu 8.5.7 Display contrast Your insulin pump allows you to adjust the display contrast. Make sure the SETUP MENU ADVANCED is turned on. Press d to move to the SETUP MENU ADVANCED. Select with f. Press d to move to the DISPLAY CONTRAST screen.

  • Page 143: Data Transfer

    Accu-Chek Insulin Pump Configuration Software on your computer and your Accu-Chek Spirit insulin pump using this data transfer. Infrared communication with your PC is established via an infrared adapter, which is connected to your PC’s RS232 serial interface.
  • Page 144 Prepare your PC and Accu-Chek Insulin Pump Configuration Software for data transfer (see Accu-Chek Insulin Pump Configuration Software user manual). Make sure your insulin pump is in STOP. Press d to move to the COMMUNICATION menu.
  • Page 145 Data transfer Check the configuration on your insulin pump to make sure that all parameters are written correctly. Set up your insulin pump with a cartridge, adapter and a new infusion set and put it into RUN, if necessary. Note Your insulin pump automatically returns to STOP 15 minutes h after the last data transfer respectively when the DATA TRANSFER screen has been selected.

  • Page 147: Alerts And Errors

    Alerts and errors 10 Alerts and errors When your insulin pump is in use, a two microprocessor safety system continuously monitors and controls the insulin pump. Over 9 million safety checks are performed daily to secure all relevant functions. If your insulin pump detects a deviation of its normal state, an alert (warning instruction) or an error (error message) will occur.
  • Page 148 Alerts and errors To confirm an alert or error Press f to turn off the beeps and vibrations. The alert or error code remains on the display. Confirm that you have seen and understood the alert or error code and messages by pressing f again.

  • Page 149: Alerts

    Alerts and errors 10.1 Alerts Warning After the occurrence of an alert, your insulin pump may be in STOP and the 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 insulin pump into RUN to continue the insulin delivery.

  • Page 150: Alert A2: Battery Low

    10.1.3 Alert A3: REVIEW TIME AND DATE If the battery is removed for more than 1 hour, it may be necessary to enter the time and date again. Other Accu-Chek Spirit settings and the event memory are not affected and are preserved, regardless of battery voltage and time your insulin pump has been without a battery.

  • Page 151: Alert A4: Alarm Clock

    To ensure that insulin delivery is optimized, your pump features a pump timer. To inspect the pre-set lifetime of your Accu-Chek Spirit pump before you start using it, please refer to the “Accu-Chek Spirit Pump Protocol” included in the starter kit. During use, the remaining lifetime in days until the expiration date of your insulin pump can be reviewed in the INFORMATION menu (see “Review the time remaining”).

  • Page 152: Alert A6: Tbr Cancelled

    Accu-Chek Spirit insulin pump will display the symbol to remind you to check the timer. Contact your local HelpDesk to discuss your options for further use of the Accu-Chek Spirit insulin pump. Note The alert A5: PUMP TIMER and the error E5: END OF OPERATION are based on running time (period with pump in RUN) and not calendar years.

  • Page 153: Alert A7: Tbr Over (Temporary Basal Rate Over)

    Decide whether a further temporary basal rate change is appropriate and program, if necessary. Note If desired, the alert A7: TBR OVER can be turned off using Accu-Chek Insulin Pump Configuration Software. If turned off, the alert does not occur when a temporary basal rate ends.

  • Page 154: Errors

    Alerts and errors 10.2 Errors Warning After the occurrence of an error, your insulin pump will be in STOP and the insulin delivery is interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each error code.

  • Page 155: Error E2: Battery Depleted

    Alerts and errors 10.2.2 Error E2: BATTERY DEPLETED Warning After inserting a new battery, always ensure that the time and date of your insulin pump are set correctly. Incorrect programming of the time and date may cause incorrect insulin delivery. If you or your healthcare team store and analyse your therapy data electronically and the time and date of the devices used are not set identically, the gathered data might not be meaningful.

  • Page 156: Error E4: Occlusion

    For example, a blocked infusion set – with a basal rate of 2.0 U/h (no additional boluses) would have an error E4: OCCLUSION in approximately three hours or less using Accu-Chek 3.15 ml plastic cartridges, depending on the type and severity of the blockage.
  • Page 157 Alerts and errors With a disconnectable infusion set do the following: Press f twice to turn off and confirm the error. Disconnect the infusion set tubing from the infu- sion site. Activate the PRIMING function. If no error E4: OCCLUSION occurs, the occlusion is within the infusion set cannula.
  • Page 158 Alerts and errors With a non-disconnectable infusion set do the following: Press f twice to turn off and confirm the error. Remove your infusion set from the infusion site and afterwards from your insulin pump. Activate the PRIMING function without an attached infusion set.

  • Page 159: Error E5: End Of Operation

    To ensure that insulin delivery is optimized, your pump features a pump timer. To inspect the pre-set lifetime of your Accu-Chek Spirit pump before you start using it, please refer to the “Accu-Chek Spirit Pump Protocol” included in the starter kit. During use, the...

  • Page 160: Error E6: Mechanical Error

    Alerts and errors 10.2.6 Error E6: MECHANICAL ERROR With every insulin delivery (at least every 3 minutes) and each time you put your insulin pump into RUN, the safety system of your insulin pump reviews all mechanical parameters. If a mechanical error is discovered during this process, the insulin delivery is stopped and an error E6: MECHANICAL ERROR occurs.

  • Page 161: Error E7: Electronic Error

    Alerts and errors 10.2.7 Error E7: ELECTRONIC ERROR The safety system of your insulin pump continuously monitors the functioning of your insulin pump. If an electronic error is discovered, the insulin delivery is stopped and an error E7: ELECTRONIC ERROR occurs. You cannot turn off and confirm an error E7: ELECTRONIC ERROR by pressing f, remove the battery instead.

  • Page 162: Error E8: Power Interrupt

    Alerts and errors 10.2.8 Error E8: POWER INTERRUPT A power interrupt may occur when you change the battery without putting your insulin pump into STOP first, or when your insulin pump was dropped. Press f twice to turn off and confirm the error. Your insulin pump goes into STOP.

  • Page 163: Error E10: Cartridge Error

    Alerts and errors 10.2.9 Error E10: CARTRIDGE ERROR If the CHANGE THE CARTRIDGE function was not correctly carried out, an error E10: CARTRIDGE ERROR will occur. Press f twice to turn off and confirm the error. Remove or disconnect the infusion set from your infusion site.

  • Page 164: Error E11: Set Not Primed

    Alerts and errors 10.2.10 Error E11: SET NOT PRIMED Warning Never prime an infusion set that is connected to your body. You risk uncontrolled insulin delivery into your body. With disconnectable infusion sets, make sure you have disconnected the tubing from your site prior to priming.

  • Page 165: Error E12: Data Interrupted

    Before you can put your insulin pump into RUN, the data transfer must be successfully concluded. Refer to the Accu-Chek Insulin Pump Configuration Software user manual for further instructions on using the data transfer feature. Press f twice to turn off and confirm the error.

  • Page 166: Error E13: Language Error

    Alerts and errors 10.2.12 Error E13: LANGUAGE ERROR When an error E13: LANGUAGE ERROR occurs check the language and reset if necessary. Press f twice to turn off and confirm the error. Refer to the ADVANCED SETUP MENU for instructions on how to change the language. When finished, put your insulin pump into RUN, if necessary.

  • Page 167: Troubleshooting

    This section describes some potential problems that may occur while using your Accu-Chek Spirit insulin pump. See sections 10 “Alerts and errors”, 12 “Life with your Accu-Chek Spirit insulin pump” and 14 “Care of your Accu-Chek Spirit insulin pump” for further information.
  • Page 168 Troubleshooting Problems with your Accu-Chek Spirit Problem Recommended Actions Individual characters, numbers or Contact your local Customer Care Area. symbols on the display are shown incompletely or not at all. Your insulin pump does not beep or Check that the beep volume and the vibrate.
  • Page 169 Troubleshooting Problem Recommended Actions Air bubbles in the cartridge and/or In the cartridge: Disconnect and re-prime infusion set your infusion set. Should the air bubbles remain, replace the cartridge. In your infusion set: Disconnect and prime your infusion set. Make sure all connections are tight and secure.
  • Page 170 Troubleshooting Problem Recommended Actions Infusion site becomes sore, red or Change your infusion set and infusion swollen site immediately. Use proper insertion technique and always follow the planned infusion site rotation pattern and advice given by your doctor or healthcare team. Therapy-related issues Many additional factors, such as alcohol consumption, medications other than insulin, ineffective or expired insulin, decreased activity, illness and...

  • Page 171: Life With Your Accu-Chek Spirit Insulin Pump

    Life with your Accu-Chek Spirit insulin pump 12 Life with your Accu-Chek Spirit insulin pump 12.1 Recommendations for daily use Caution Training and use of your insulin pump require the support of an experienced doctor or healthcare team. Regular visits with your doctor or healthcare team are absolutely essential during insulin pump therapy.

  • Page 172: Continuation Of Insulin Pump Therapy

    Life with your Accu-Chek Spirit insulin pump 12.1.2 Continuation of insulin pump therapy 1. Attach a new Accu-Chek infusion set and prime it prior to insertion. When using a disconnectable infusion set, reconnect the tubing. 2. Follow the instructions for the infusion set you are using, and put your insulin pump into RUN.

  • Page 173: Weather Conditions

    Life with your Accu-Chek Spirit insulin pump 12.2 Weather conditions Wear your insulin pump under your clothes or directly on your body in cold and rainy weather. In case of doubt regarding these conditions, check the operating conditions of your insulin pump and contact your local Customer Care Area.

  • Page 174: Your Insulin Pump And Water

    Life with your Accu-Chek Spirit insulin pump 12.3 Your insulin pump and water Caution Avoid deliberate contact with water. Check daily that your insulin pump is not chipped, cracked or damaged in any way and that the battery cover and the adapter are correctly closed.

  • Page 175: Accidental Contact With Water

    Do not use warm air (e.g. a hair dryer) to dry as this could damage the internal electronics of your insulin pump. Do not insert the battery or the cartridge before these compartments are completely dry. See the section 14.2.1 “Cleaning your Accu-Chek Spirit insulin pump” for further information.

  • Page 176: Other Liquids

    • cleaning solutions • alcohol • beverages See the section 14.2.1 “Cleaning your Accu-Chek Spirit insulin pump” for further information. Caution Avoid any contact of your insulin pump, the infusion set and the connecting parts of your insulin pump with health and beauty items (e.g.

  • Page 177: On The Go With Your Accu-Chek Spirit Insulin Pump

    On the go with your Accu-Chek Spirit insulin pump 13 On the go with your Accu-Chek Spirit insulin pump 13.1 Electromagnetic fields and hazardous areas Avoid electromagnetic fields of radar or antenna installations, high-voltage sources, X-Ray sources, MRI, CAT scan or other sources of electrical cur- rent.

  • Page 178: Sports

    13.2 Sports Exercise is an important aspect in the management of diabetes. Of course, you can perform sporting activities with the Accu-Chek Spirit insulin pump. However, prior to starting these types of activities be sure to protect your insulin pump. Do not wear your insulin pump during sports with body contact (e.g.

  • Page 179: Care Of Your Accu-Chek Spirit Insulin Pump

    Care of your Accu-Chek Spirit insulin pump 14 Care of your Accu-Chek Spirit insulin pump Caution Do not perform any servicing or repair on your insulin pump by yourself. For any questions contact your local Customer Care Area. Roche Diagnostics as the manufacturer guarantees the functions of...
  • Page 180 Care of your Accu-Chek Spirit insulin pump Check your insulin pump daily. Make sure that: • The pump casing, the display and the cartridge are free of chips or cracks and the display is free of incomplete or abnormal letters or symbols.

  • Page 181: Maintenance And Cleaning

    Care of your Accu-Chek Spirit insulin pump 14.2 Maintenance and cleaning 14.2.1 Cleaning your Accu-Chek Spirit insulin pump The ideal time to clean your insulin pump is during the change of a cartridge. Only use a soft, dry cloth for cleaning. If the insulin pump compartments are excessively dirty, consult your local Customer Care Area for further instructions.

  • Page 182: Storing Your Accu-Chek Spirit Insulin Pump

    • To operate your insulin pump, the operating temperature of the battery must be +5 °C to +40°C (+41°F to +104°F). • Tighten or loosen the battery cover with the Accu-Chek Spirit battery key (use of knives, screwdrivers or other sharp objects may harm your insulin pump).

  • Page 183: When Your Insulin Pump Is Dropped

    Dropping may harm your insulin pump and damage the seal against water. Make sure that your insulin pump is not dropped. Use the proper Accu-Chek Spirit carrying systems for the various daily situations to prevent dropping. If your insulin pump is dropped: •...

  • Page 184: Repair

    Care of your Accu-Chek Spirit insulin pump 14.5 Repair Caution Do not perform any servicing or repair on your insulin pump by yourself. Do not use any lubricant on the pump mechanism. For additional questions contact your local Customer Care Area.

  • Page 185: Disposal

    Care of your Accu-Chek Spirit insulin pump 14.6 Disposal Accu-Chek Spirit insulin pump If necessary, return your insulin pump to your local Customer Care Area for professional disposal. Battery Dispose of depleted batteries at your nearest battery disposal center. Cartridge, infusion set, adapter and additional accessories Dispose of these items in your normal garbage.

  • Page 187: Technical Data

    Technical data 15 Technical data 15.1 General technical data Maximum dimensions Approx. 81 20 mm (without adapter) (3.2 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 188 Technical data Power supply One 1.5 volt AA Alkaline battery or one rechargeable NiMH AA battery. Alkaline batteries should have a minimum capacity of 2500 mAh and NiMH AA rechargeable batteries a mini- mum capacity of 1500 mAh. Use only a battery charger officially recommended by the battery manufacturer.
  • Page 189 Technical data Bolus The max. bolus amount per delivery is 25 insulin units. The bolus amount for the “Quick” Standard bolus is adjustable in increments of 0.1, 0.2, 0.5, 1.0 and 2.0 units. For the “Scroll” Standard bolus, the Extended bolus and the MultiWave bolus, the amount is adjustable in fixed increments of 0.1 units.
  • Page 190 Accu-Chek 3.15 ml plastic cartridges with a luer connection and by Roche Diagnostics approved third party products. Aventis Insuman Infusat cartridges* have been evaluated and approved for use with the Accu-Chek Spirit insulin pump. Infusion sets Accu-Chek infusion sets with a luer-lock connector.
  • Page 191 Technical data Safety 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 iden- tified by the supervisor processor.

  • Page 192: Technical Standards On Electromagnetic Emissions

    Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Accu-Chek Spirit uses RF energy only for its CISPR 11 internal function. Therefore, its RF emissions are very low and are not likely to cause any interfer- ence in nearby electronic equipment.

  • Page 193: Technical Standards On Electromagnetic Immunity

    Guidance and manufacturer’s declaration – electromagnetic immunity The Accu-Chek Spirit is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit should assure that it is used in such an environment. Immunity test...
  • Page 194 IEC 61000-4-3 80 MHz to 80 MHz to 2.5 should be used no closer to any 2.5 GHz part of the Accu-Chek Spirit, including cables, than the rec- ommended separation distance (IEC 60601-2-24) calculated from the equation applicable to the frequency of the transmitter.
  • Page 195 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Accu-Chek Spirit is used exceeds the applica- ble RF compliance level above, the Accu-Chek Spirit should be observed to verify normal operation.
  • Page 196 Technical data Accuracy of flow rate for both Accu-Chek 3.15 ml plastic cartridges and Aventis glass cartridges*** Trumpet curve plotted from data after the end of the stabilization period The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.
  • Page 197 Influence of height on delivery accuracy The maximum deviation of the delivered amount (overall mean percentage flow error) for U100 insulin is 10 %* in case your Accu-Chek Spirit insulin pump is located 1 m (3.3 feet) above/below the infusion site.

  • Page 198: Configuration Parameters

    Software. Always consult your doctor or healthcare team before changing parameters. The Accu-Chek Spirit allows you to customize your user menus. If a menu does not appear, see the section 6 “Select a user menu (STANDARD, ADVANCED or CUSTOM)” and the Accu-Chek Insulin Pump Configuration Software user manual for further information on addressing all menus on your insulin pump.
  • Page 199 Technical data Typical range available Maximum parameter range on the pump and adjustable with the Accu-Chek standard parameter Insulin Pump Configuration settings* Software Basal rate – hourly basal rate + max. 20.0 IU/h max. amount TBR (hourly basal rate 0 – 62.50 IU/h combined with temporary basal rate, max.
  • Page 200 Technical data Typical range available on the pump and standard parameter settings* Display orientation standard or inverted presetting: standard Display contrast 7 steps presetting: medium User menus 3 (STANDARD, ADVANCED or CUSTOM) presetting: ADVANCED off, 1 – 4 steps Volume (for beeps) presetting: medium beeps, vibrations or both Alarm signals turned on...

  • Page 201: Annexes

    Annexes 16 Annexes 16.1 Abbreviations approx. Approximately Basal rate Basal rate profile Diabetes Data Management Hour(s) International Electrotechnical Commission incl. Inclusive Infrared I.U., IU International Units in context with biological effectiveness of a certain insulin amount Kilo pascals Liquid Crystal Display Light Emitting Diode for infrared communication with e.g.
  • Page 202 Annexes U100 This is the insulin concentration. Each millilitre of liquid contains 100 International Units of insulin. dd.mm.yy European date format: day.month.year mm/dd/yy American date format: month/day/year...

  • Page 203: Beeps And Melodies

    Annexes 16.2 Beeps and melodies You can turn off the beeps or the vibrations, but not both at the same time. Please refer to sections 7.7.2 “Adjust the beep volume” and 7.7.3 “Alarm signals” for further information. Each press of Each press of Each press of , respectively...

  • Page 204: Vibrations

    You can turn off either the beeps or the vibrations, but not both at the same time. When you program a “Quick” Standard bolus, your Accu-Chek Spirit confirms all programming with vibrations. You cannot turn off these vibrations. Your Accu-Chek insulin pump vibrates when...

  • Page 205: Symbols

    Annexes 16.4 Symbols 16.4.1 General symbols Read user guide Sterilized using ethylene oxide Sterilized using radiation Sterilized using antiseptics Year of manufacture Batch number Expiration date Item number Serial number Admissible temperature range during operation Admissible temperature range Admissible humidity range Admissible air pressure range Fragile –...
  • Page 206 Annexes For single use only Does not contain pyrogen Does not contain PVC Recycling Do not throw away Do not use if the package is damaged Flammable Electronic device of type BF according the standard IEC 60601-1. Protection against electrical shock. Symbol for protection against the effect of temporary IPX8 immersion of water (up to 60 minutes and 2.5 meters...

  • Page 207: Display Symbols

    Annexes 16.4.2 Display symbols Start your Accu-Chek Spirit STOP screen and Stop insulin delivery Time, and Set the time and date menu Date Locked keys when the KeyLock function is turned on Unlocked keys when the KeyLock function is turned on...
  • Page 208 Annexes Standard bolus and Bolus increment programming Extended bolus and extended delivery of the MultiWave bolus MultiWave bolus Immediate bolus delivery of MultiWave bolus Decreased temporary basal rate (0 – 90 %) Increased temporary basal rate (110 – 200 % h) Remaining duration of an ongoing Extended bolus, MultiWave bolus, TBR or automatic off Daily total of insulin delivered...
  • Page 209 Annexes Beeps and vibrations turned on Set beep volume Screen orientation European date format American date format Alarm clock turned on Alarm clock turned off Single alarm when set an alarm clock Every day repeat alarm when set an alarm clock PC communication Menu key Check key...

  • Page 210: Sterile Products And Accessories

    Annexes 16.5 Sterile products and accessories 16.5.1 Sterile products Cartridges Name Comments Accu-Chek 3.15 ml Plastic Cartridge Plastic cartridges are single-use items Aventis Insuman Infusat Pre-filled only. 3.15 ml Glass Cartridges* (U100) Do not reuse cartridges. Refer to the instructions for use of the...

  • Page 211: Accessories

    If used in a normal usage pattern, the carrying systems have a life of approximately one year. Accu-Chek Insulin Pump Two versions of the pump configuration Configuration Software software are available; a consumer version and a healthcare professional version.

  • Page 213: Glossary

    Glossary 17 Glossary Accu-Chek Insulin Pump Configuration Software Roche Diagnostic’s insulin pump programming tool. This software allows the fast and easy change of parameters and settings directly from your Microsoft Windows compatible PC. Adapter The adapter physically connects the cartridge and infusion set. It has two seals and forms an efficient seal for the cartridge compartment of your insulin pump.The two small vents on the adapter allow air pressure to...
  • Page 214 Factory settings Your insulin pump is provided by Roche Diagnostics with a standard configuration (factory settings). These settings can be adapted to your individual needs directly on your insulin pump or by using the Accu-Chek Insulin Pump Configuration Software.
  • Page 215 Glossary Filling aid The filling aid can be used to help you fill an empty Accu-Chek 3.15 ml plastic cartridge from your vial of insulin. Free flow Free flow of insulin from the infusion may occur when two conditions are met.
  • Page 216 Accu-Chek Insulin Pump Configuration Software. During normal use, your insulin pump is in RUN and insulin is continuously delivered.
  • Page 217 Glossary STOP When your insulin pump is in STOP, it does not deliver any insulin. The insulin delivery is only stopped if an error occurs or if your insulin pump is put into a necessary STOP, (e.g. when changing the cartridge, adapter or infusion set or for data transfer).

  • Page 219: Index

    Bolus ....95 Accu-Chek Insulin Pump cancelled ....151 Configuration Software .
  • Page 220 Index Daily totals history ..116 Infection ....66 Data interrupted ... 163 Infusion set.
  • Page 221 Index Maintenance ....179 Pump programming software. . 44 Malfunction....37 Pump therapy ... . 9, 11 reusing single-use materials Pump timer.
  • Page 222 Index TBR; see “Temporary basal rate”....102 Temporary basal rate ..102 cancelled ....150 decrease .
  • Page 223 For a complete review of your insulin pump features as well as orientation the warnings and precautions associated with its use, please refer to your Accu-Chek Spirit Insulin pump user’s guide. Your Insulin pump ADVANCED MENU KeyLock quick info...

  • Page 224: Alert Overview

    BATTERY DEPLETED Change the battery. BATTERY LOW Replace the battery as soon as AUTOMATIC OFF Put your Accu-Chek Spirit in RUN if possible. necessary. REVIEW TIME AND DATE Set the time and date. OCCLUSION See the appropriate section in this user...
  • Page 226 ACCU-CHEK, ACCU-CHEK SPIRIT, ACCU-CHEK TENDERLINK, ACCU-CHEK FLEXLINK, ACCU-CHEK RAPIDLINK and DISETRONIC are trademarks of Roche. Disetronic Medical Systems AG 3401 Burgdorf, Switzerland Swiss made www.accu-chek.com...

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