Summary of Spirit

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    Insulin pump user guide.

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    The accu-chek spirit – at a glance display up key down key infusion set adapter cartridge check key menu key this user’s guide is valid for version 2.Xx of the accu-chek spirit..

  • Page 3: Useful Addresses

    1 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 i...

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    2 your contact for assistance with and/or additional information about your accu-chek spirit insulin pump: united kingdom: roche diagnostics ltd. Charles avenue burgess hill west sussex, rh15 9 ry united kingdom phone +44 1444 256 000 lewes.Insulinpumps@roche.Com www.Accu-chek.Co.Uk australia: roche...

  • Page 5: 1 Introduction

    1 introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1.1 who this user guide is written for . . . . . . . . . . . . . . . . . . . . . . . 9 1.2 how to use this user guide . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 1.3 working safely w...

  • Page 6: 5.2  Start-Up Procedure

    5 preparing the pump for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.1 insert and change the battery . . . . . . . . . . . . . . . . . . . . . . . . . 45 5.2 start-up procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 5.2.1 prepare the cartridge...

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    7.6 temporary basal rate (tbr) . . . . . . . . . . . . . . . . . . . . . . . . . . 102 7.6.1 program a temporary basal rate . . . . . . . . . . . . . . . . . . 103 7.6.2 cancel a temporary basal rate . . . . . . . . . . . . . . . . . . . . 105 7.7 setup menu standard . . . . . . . . . . . . . . . . ...

  • Page 8: 9 Data Transfer

    9 data transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 10 alerts and errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 10.1 alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1...

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    12.3 your insulin pump and water . . . . . . . . . . . . . . . . . . . . . . . . 172 12.3.1 daily situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 12.3.2 accidental contact with water . . . . . . . . . . . . . . . . . . 173 12.3.3 what to do after water contact . . . . . . . ...

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    8.

  • Page 11: 1 Introduction

    1 introduction 1.1 who this user guide is written for you are a highly motivated diabeties patient who is willing to work with your doctor and/or healthcare team on insulin therapy. From the start it is very important that you take the time to train with a healthcare professional on the insulin pump...

  • Page 12: Note

    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 healthc...

  • Page 13: Note

    See the sections 10 “alerts and errors” and 15 “technical data” for further information on how to address these issues. Note your insulin pump is a valuable medical device. We strongly encourage you to add your insulin pump to your homeowner’s insurance policy to protect you in case of accidental da...

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    12.

  • Page 15: 2 Before You Begin

    2 before you begin 2.1 warnings and cautions for proper use and your safety to ensure that there is no risk to you or your health, you should be aware of the following warnings regarding set-up, hygiene and secure use prior to using your accu-chek spirit insulin pump. Please read through these warni...

  • Page 16: Run

    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. Put your insulin pump into run to continue the insulin ...

  • Page 17: Intended For Single Use

    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 produc...

  • Page 18: Pump By Yourself.

    ➨ 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. ➨ alw...

  • Page 19: Least Once A Day.

    ➨ check the amount of insulin remaining in the cartridge at least once a day. Before going to bed, make sure that the cartridge contains enough insulin to last through the night. ➨ contact your doctor or healthcare team for an alternate therapy plan when you interrupt the insulin pump therapy for a ...

  • Page 20: Level.

    18 before you begin 2.1.4 warnings and cautions for secure use ➨ the interruption of insulin delivery (e.G. Due to a leak, occlusion or loss of insulin potency) or the malfunction of your insulin pump can result in a rapid rise of your blood glucose level. Although your insulin pump has an internal ...

  • Page 21: Use Only Insulin

    ➨ 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. Remove any air bubbles and, if ne...

  • Page 22: Stop

    20 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. In order ...

  • Page 23: Medical Devices.

    ➨ your insulin pump is designed to work in normal barometric conditions from 70 to 106 kpa (700 to 1060 mbar). Do not exceed 3000 meters (10 000 feet) above sea level. It has not been tested for use in hazardous areas of any classification. Always stop and remove your insulin pump prior to entering ...

  • Page 24: Correctly Inserted.

    ➨ 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. The battery cover is correc...

  • Page 25: To Be Returned

    ➨ if you cannot feel the vibration alert, 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. ➨ if you discover incomplete characters, numbers or symbols on the display, your ins...

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  • Page 27: 3.1  Display

    3 the accu-chek spirit insulin pump 3.1 display your insulin pump has a full graphic lcd (liquid crystal display) which displays important current and historical information. Check the display of your insulin pump at least every three hours during the day, before you go to sleep, and especially if f...

  • Page 28: 3.2  Backlight

    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, from the stop screen or when browsing the menus, by pressing a . The backlight turns on automatically when an alert or error message appears...

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    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: key name function d menu move through menus, function and information screens f check select a menu save changes and exit the function and information screen vi...

  • Page 30: Warning

    A plus symbol (+) connecting 2 key functions means that both keys must be pressed simultaneously: key combination name function d + a menu and up exit a menu or function and information screens. Loop backward in the menu structure. D + s menu and down unlock the keylock (press and hold simultaneousl...

  • Page 31: 3.4  Keylock

    3.4 keylock symbol beep display comment a sequence of beeps means that all if no keylock symbol (you will hear 3 beeps 4 keys are locked appears in the run in run and 1 beep in (except a for turning or stop screen, the stop ). On the backlight). Keylock function is turned off. Means that all 4 keys ...

  • Page 32: 3.5  Scrolling

    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. This value can be corrected by a single press of s or a...

  • Page 33: 3.6  Status Screen

    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 ti...

  • Page 34: 3.8  Run And Stop Modes

    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 . After any programming or review of information, the insuli...

  • Page 35: 3.9  Stop-Warning

    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. If the stop -warning is turned on, it occurs every minute with a long beep and a vibration. ...

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  • Page 37: Caution

    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. Your accu-chek spirit insulin pump, sterile products, accessories and software sh...

  • Page 38: 4.1  Sterile Products

    Consult our sterile products brochures and accessories catalogue or your local customer care area for more information. 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 e...

  • Page 39: 4.1.1  Cartridge

    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. Do not use sterile products if the package is damaged. Lo...

  • Page 40: 4.1.2  Infusion Sets

    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. The cannula or needle of the infusion s...

  • Page 41: 4.2  Adapter

    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" 18 units see the sections 5.3.1 “connect the cartridge, adapter and infusion set”, 5.4 “prime the infusion ...

  • Page 42: 4.3  Battery

    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 150...

  • Page 43: Note

    Note many types of batteries on the market are not designed to provide adequate power for your insulin pump. To ensure that the battery lasts as long as possible, be sure to use alkaline batteries with a minimum capacity of 2500 mah or nimh (rechargeable) batteries with a minimum capacity of 1500 ma...

  • Page 44: 4.5  Battery Key

    See the section 5.1 “insert and change the battery” for further information. 4.5 battery key use the battery key to tighten and to loosen the battery cover. You may also use it to loosen the luer-lock connection between your infusion set and adapter if it cannot be loosened by hand. The battery key ...

  • Page 45: 4.6  Emergency Kit

    4.6 emergency kit it is recommended that you take a small amount of supplies with you in case of an emergency. This allows you to exchange components when needed. Such an emergency kit may contain: • a new accu-chek infusion set • a new aa alkaline battery • a new 3.15 ml plastic cartridge • a pen o...

  • Page 46: 4.7  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. Accu-chek insulin pump conf...

  • Page 47: 5 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. Your in...

  • Page 48: Stop

    Your insulin pump is powered with a single 1.5 volt aa battery. See chapter 4.3 “battery” for more detailed information on recommended batteries. Make sure your insulin pump is in stop and the keylock is unlocked or turned off. Remove or disconnect your infusion set from the infusion site to ensure ...

  • Page 49: Stop

    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. Put the battery cover on the positive end of the bat...

  • Page 50: Note

    Note if your insulin pump was in run before you removed the battery, an error e8: power interrupt occurs. Press twice f to confirm and to turn off the error. Check the time and date in the stop screen and correct, if necessary. Put your insulin pump into run , if necessary. 5.2 start-up procedure yo...

  • Page 51: Note

    Note when your insulin pump is in use, its safety system monitors its functioning continuously. If it detects a deviation from the normal state, an alert (warning instruction) or an error (error message) occurs. The software version (sw version) of your insulin pump appears on the display. The accu-...

  • Page 52: Caution

    Your insulin pump vibrates and vibration test appears. Check the vibrations. The display turns white. Check that the display is empty. The backlight should turn on during this step. The display shows a pattern. Check that the pattern is uniform. The display turns black. Check that the display is com...

  • Page 53: Note

    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. Note if your insulin pump detects an alert...

  • Page 54: Warning

    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. Do not use sterile products if the pa...

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    A cartridge set consists of the following items: 1. 3.15 ml plastic cartridge with protective cap, plunger rod and filling needle. 2. Instructions for use filling needle with protective cap cartridge cartridge protective cap plunger rod plunger 53 prepare the pump for use.

  • Page 56: 5.2.2  Fill The Cartridge

    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...

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    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. Remove the protective cap from the needle. Ensure t...

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    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. Slowly release the pressure against the plunger rod a...

  • Page 59: Note

    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. Th...

  • Page 60: Note

    5.3 insert the cartridge, adapter and infusion set note prior to changing the cartridge, adapter and infusion set, care should be taken to ensure that your insulin pump is in good, working order. See the section 14.1 “system check” for the inspection checklist. Free flow of insulin from the cartridg...

  • Page 61: Warning

    Remove the cartridge protective cap. Make sure that you do not touch the cartridge tip. Push the adapter onto the cartridge tip as far as to the stop (a). 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). Do no...

  • Page 62: Note

    Note your insulin pump cannot detect infusion set leakage. You must inspect all parts of the infusion set at least every three hours during the day and before you go to sleep. Should you detect any loss of insulin and all parts are correctly tightened, immediately replace the leaking component. Beca...

  • Page 63: Stop

    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. Select with f . Remove the ...

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    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...

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    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. – continue with these instructions when the cartridge is cor...

  • Page 66: Warning

    5.4 prime the infusion set your insulin pump automatically stops priming after 25 units h of insulin. If insulin has not emerged from the infusion set needle after priming, repeat the prime function. When insulin emerges from the tip of the needle, press any of your insulin pump’s keys to stop primi...

  • Page 67: Stop

    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. Press and hold f until you hear a melody and the piston rod moves forward. The priming process starts an...

  • Page 68: Stop Priming

    66 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...

  • Page 69: Stop

    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. Make sure your insulin pump is in ...

  • Page 70: Note

    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. See the secti...

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    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. Do not use sterile products if the packag...

  • Page 72: Stop

    Have the following materials ready: your accu-chek spirit insulin pump a new accu-chek infusion set a disinfectant for skin make sure your insulin pump is in stop . Remove your infusion set from your infusion site. Remove the infusion set from the adapter and dispose of it properly. Note the battery...

  • Page 73: Stop

    5.7 change the cartridge and infusion set have the following materials ready: your accu-chek spirit insulin pump a filled accu-chek 3.15 ml plastic cartridge a new accu-chek infusion set a new adapter (must be changed at least with every 10 th cartridge) a disinfectant for skin make sure your insuli...

  • Page 74: Note

    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. Note ensure that the cartridge plunger h...

  • Page 75: 5.8  Change The Adapter

    5.8 change the adapter it is recommended to replace the adapter at least after every 10 th insulin cartridge. Replace an used adapter with a new one while changing a cartridge. See the section 5.3.1 “connect the cartridge, adapter and infusion set” for further information. 5.9 how to wear your pump ...

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  • Page 77: 6 Select A User Menu

    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. 1 st level 2 nd level 3 rd level run screen and menus function screens and stop screen information screens this level is the home this lev...

  • Page 78: Run

    6.2 navigate through the menus 1. Press d to move to the menus (2 nd level). 2. When you reach the desired menu, press f to enter (3 rd level). 3. Press a or s to increase or decrease the selected value. 4. Press d again to move to the next function screen you want to change. 5. When finished, press...

  • Page 79: 6.2.1  Scrolling

    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” so that you automatically return to the first fun...

  • Page 80: 6.2.5  Select A User Menu

    78 select a user menu (standard, advanced or custom) 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 d...

  • Page 81: Note

    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) – change basal rate profile – program basal rate profile 2, 3, 4 and/or 5 – alarm clock – setup me...

  • Page 82: Note

    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. Press a or s to select the desired user menu. Confirm with f . The newly selected basal rate profile and its daily insul...

  • Page 83: Caution

    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. 81 select a user menu (s...

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  • Page 85: 7 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 stor...

  • Page 86: Warning

    Warning incorrect setting of time and date can lead to incorrect insulin delivery. Make sure that the time and date of your insulin pump is programmed correctly to ensure the correct insulin delivery and data memory. Do not make therapy decisions based upon a single result in the insulin pump’s memo...

  • Page 87: Set Time and Date

    Set time and date press d to move to the set time and date menu. Select with f . Press a or s to set the hour . Press d to move to the minutes. Press a or s to set the minutes . Press d to move to the year. Press a or s to set the year . Set the hour set the time and date run screen set the minute s...

  • Page 88: Month

    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 – press f . Your insulin pump returns to the run screen. If yo...

  • Page 89: 7.2  Basal Rate

    7.2 basal rate your insulin pump delivers insulin every three minutes, 20 equal doses each hour, 24-hours a day. This flow of insulin, measured in international units per hour (u/h), is called the basal rate and is calculated to meet your basic insulin needs. An accu-chek spirit basal rate profile c...

  • Page 90

    7.2.1 program a basal rate profile 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. The first hour, which always begins at midnight (00:00 – 01:00 or 12:00 am – 01:00 am if the american time format i...

  • Page 91: Note

    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. Confirm with f . The new daily basal rate total is...

  • Page 92

    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. Press a + s simultaneously. A sp...

  • Page 93: Run

    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. Note since only...

  • Page 94: 7.3  Start Insulin Delivery

    7.3 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...

  • Page 95: 7.4  Stop Insulin Delivery

    7.4 stop insulin delivery for your safety there are functions and actions that require that your insulin pump is in stop. These functions and actions include: • changing the cartridge • connecting and disconnecting the adapter and/or infusion set • priming the infusion set and • data transfer from t...

  • Page 96: Note

    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. See the sections 10.1....

  • Page 97: 7.5  Program A Bolus

    95 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 doct...

  • Page 98: 7.5.1  Standard Bolus

    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 a and s keys of your menu-guided using the d and f insulin pump, with bolus increments keys with the a and s keys for determined by the user. Prog...

  • Page 99: Note

    97 standard user menu 7.5.2 program a “quick” standard bolus the following programming sequence involves only the a and s keys of your insulin pump. The sequence is “reversible”, meaning you can start with either key. The recommended sequence is always described with the first key appearing (without...

  • Page 100: Note

    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. Each press of the a ( s ) key adds one bolus increment to the bolus ...

  • Page 101: Run

    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 af...

  • Page 102

    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 bol...

  • Page 103: Run

    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). • exit to the...

  • Page 104: Note

    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. Typically, a basal rate is set to 100 %, but you can increase ...

  • Page 105: Run

    103 standard user menu 7.6.1 program a temporary basal rate 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. Note if no temporary basal rate is currently active, the percentage is set to 100 %. If a tem...

  • Page 106: Note

    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. Note at any screen you have three opt...

  • Page 107: Run

    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 – during programming: you have three options for cancelling a temporary bas...

  • Page 108: Stop

    • 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. Note if an extended bolus or a multiwave bolus is active...

  • Page 109: 7.7  Setup Menu Standard

    7.7 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 – press f . Your insulin...

  • Page 110: Turn The Keylock On Or Off

    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. Press d to move to the setup menu standard. Select with f . The current keylock status (on or off) appears. Press a or s to turn the keylock on or off....

  • Page 111: Unlock The Keylock

    Unlock the keylock 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. If no fu...

  • Page 112: Note

    110 standard user menu press a or s to adjust the beep volume. You can choose between 5 volume levels: no beeps (beeps are turned off) very low low normal maximum save and exit with f . Note the volume of the stop -warning is independent of the programmed beep volume. It always occurs at the maximum...

  • Page 113: 7.7.4  Automatic Off

    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 automatic off is a safety feature which stops all insulin delivery by triggering an error e3: automatic off if no keys are...

  • Page 114: 7.7.5  Battery Type

    7.7.5 battery type your insulin pump has the option of using 1.5 volt aa alkaline batteries or rechargeable aa nimh batteries. If you change from one battery type to the other, you must change the battery type accordingly in the setup menu standard. See the section 4.3 “battery” for further informat...

  • Page 115: 7.7.6  Display Orientation

    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. Select with f . Press d to move to the orientation screen. Press a ...

  • Page 116

    114 standard user menu 7.8 review data memory (information) the memory of your insulin pump stores all events (i.E. Alerts and errors, programming operations and insulin delivery records) for up to 4500 events. This data memory corresponds typically to about the last 90 days of usage and is accessib...

  • Page 117

    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 . Information menu run s creen alarm hi s tory daily total tbr hi s tory pump timer bolu s hi s tory 115 standard...

  • Page 118

    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), • alert or error (e.G. Tbr cancelled), • time ( ),...

  • Page 119

    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...

  • Page 120: Run

    7.8.5 review the time remaining your insulin pump has been designed to be a highly reliable system that will provide worry-free performance for a long period of time. To ensure optimal performance, a pump timer will limit the operating time of the pump. This timer counts the number of days of operat...

  • Page 121: 7.8.6  Quick Info Screen

    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 ...

  • Page 122

    120

  • Page 123: 8 Advanced User Menu

    121 advanced user menu 8 advanced user menu this chapter introduces you to the advanced functions of your insulin pump. 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 al...

  • Page 124: 8.1  Extended Bolus

    122 advanced user menu 8.1 extended bolus the extended bolus is only available in the advanced user menu and may be turned on or off in the custom user menu. The extended bolus function allows you to program a bolus to be delivered over a period of time. This function can be helpful during long meal...

  • Page 125: Note

    8.1.1 program an extended bolus 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. The bolus duration of the last extended bolus delivered appears, or when using your insulin pump for the first time, a d...

  • Page 126: Note

    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. Note if a tempora...

  • Page 127: Stop

    – 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. See the section 10.1.8 “alert a8: bolus cancelle...

  • Page 128: 8.2  Multiwave Bolus

    126 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 bol...

  • Page 129

    8.2.1 program a multiwave bolus 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. With the first press of the a key, the bolus duration of the last multiwave bolus appears, or when using your ins...

  • Page 130: Note

    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 . Note press d to loop between programming the ...

  • Page 131: Note

    Note once the immediate bolus is delivered, the remaining time, bolus amount and the current hourly basal rate are displayed in the run screen. If a temporary basal rate is active at the same time, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal r...

  • Page 132: Note

    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. Press f twice ...

  • Page 133: 8.3  Basal Rate Profiles

    Ensure that the cancellation was intended and program a new multiwave bolus (and/or temporary basal rate), if necessary. 8.3 basal rate profiles your insulin pump offers the option of delivering up to five h different basal rate profiles in order to easily meet changing insulin needs (for example mo...

  • Page 134: Note

    8.3.2 select a basal rate profile 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 . The current basal rate profile is displayed. Note only basal rate profiles that are accessible in your current user menu are available. ...

  • Page 135: Note

    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, – select the advanced user menu, ...

  • Page 136: 8.5  Setup Menu Advanced

    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. Press a or s to set the minute. Save and exit with f . To turn off the alarm clock wh...

  • Page 137: 8.5.2  Date Format

    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: dd.Mm.Yy, e.G. ...

  • Page 138: 8.5.3  Bolus Increment

    8.5.3 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 ...

  • Page 139: 8.5.4  Prime Quantity

    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 insuli...

  • Page 140: Note

    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 su...

  • Page 141: 8.5.6  Language

    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 . Press d to move to the language screen. Press a or s to select the desire...

  • Page 142: 8.5.7  Display Contrast

    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. Press a or s to select the desired contrast. Save and exit w...

  • Page 143: 9 Data Transfer

    9 data transfer the built-in infrared interface in the bottom cover of your insulin pump allows for wireless data transfer from your insulin pump to a pc. Pump programming information may be exchanged between accu-chek insulin pump configuration software on your computer and your accu-chek spirit in...

  • Page 144: Setup For Data Transfer

    Setup for data transfer 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. Select with f . The data transfer screen ap...

  • Page 145: Run

    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 tra...

  • Page 146

    144.

  • Page 147: 10 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 (wa...

  • Page 148: Run

    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. Take the appropriate action, if necessary. If more than one alert and/or erro...

  • Page 149: 10.1  Alerts

    10.1 alerts 10.1.1 alert a1: cartridge low if the remaining content in the insulin cartridge reaches 20 units h of insulin, an alert a1: cartridge low occurs. Your insulin pump displays that the cartridge is almost empty. Be prepared to replace the cartridge as quickly as possible. The cartridge low...

  • Page 150: Run

    10.1.2 alert a2: battery low your insulin pump checks the battery voltage before each insulin delivery (at least every 3 minutes). If it falls below a certain voltage value, the alert a2: battery low occurs. Be prepared for a battery change as quickly as possible. The battery low symbol ( ) appears ...

  • Page 151: Run

    10.1.4 alert a4: alarm clock an alert a4: alarm clock will occur at the time that you have programmed into the pump. Press f twice to turn off and confirm the alert. Put your insulin pump into run , if necessary. Note if you have set the alarm occurrence to every day, the same alert occurs again eve...

  • Page 152: Run

    Press f twice to turn off and confirm the alert. Put your insulin pump into run . Check the information screen on your pump for the pump timer display. The amount shown is the remaining number of programmed days in your insulin pump. After the alert a5: pump timer occurs, the accu-chek spirit insuli...

  • Page 153: Note

    151 alerts and errors 10.1.7 alert a7: tbr over (temporary basal rate over) an alert a7: tbr over occurs when a temporary basal rate has ended. Once the alert has been confirmed, the original basal rate (100 %) will resume automatically. Press f twice to turn off and confirm the alert. Decide whethe...

  • Page 154: 10.2  Errors

    10.2 errors 10.2.1 error e1: cartridge empty if the cartridge is empty, an error e1: cartridge empty occurs. Change the cartridge immediately. Press f twice to turn off and confirm the error. Disconnect or remove the infusion set from your infusion site. Change the cartridge and prime the new infusi...

  • Page 155: Run

    153 alerts and errors 10.2.2 error e2: battery depleted if the battery is depleted, an error e2: battery depleted occurs. Replace it immediately. Press f twice to turn off and confirm the error. Replace the battery. When finished, put your insulin pump into run . Note your insulin pump stores the se...

  • Page 156: 10.2.4  Error E4: Occlusion

    10.2.4 error e4: occlusion an error e4: occlusion occurs if insulin (a maximum of 3.5 units of insulin when using plastic cartridges or a maximum of 6 units of insulin when using aventis insuman infusat glass cartridges*) is failed to be delivered. This may be caused by: – a blocked infusion set or ...

  • Page 157: Set Cannula

    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 . Change the infusion s...

  • Page 158: Set

    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. Hold your insulin pump with the adapter poi...

  • Page 159: Stop

    10.2.5 error e5: end of operation the error e5: end of operation indicates that your pump timer has reached zero. The pump will no longer operate. Before this error occurs an alert a5: pump timer will occur to ensure that you are able to replace your pump within sufficient time. When the pump timer ...

  • Page 160: Run

    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 stopp...

  • Page 161: Cannot

    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...

  • Page 162: Stop

    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 . Check the time and date and correct, ...

  • Page 163: Run

    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. Remove the cartridge. Start the change the c...

  • Page 164: Run

    162 alerts and errors 10.2.10 error e11: set not primed if you changed the cartridge and infusion set but did not prime the infusion set, an error e11: set not primed occurs when you try to put your insulin pump into run . Press f twice to turn off and confirm the error. Remove or disconnect the inf...

  • Page 165: Run

    10.2.11 error e12: data interrupted when data transfer between your insulin pump and a pc is interrupted an error e12: data interrupted occurs. Restart communication between your insulin pump and the pc and make sure that the data transfer is completed correctly. Before you can put your insulin pump...

  • Page 166: Run

    164 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 insuli...

  • Page 167: 11 Troubleshooting

    11 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. Note th...

  • Page 168

    Problem individual characters, numbers or symbols on the display are shown incompletely or not at all. Your insulin pump does not beep or vibrate. Self-test incomplete (after an error e7: electronic error). Incorrect insulin delivery due to incorrect time setting. Incorrect insulin delivery due to i...

  • Page 169

    Problem air bubbles in the cartridge and/or infusion set blood in infusion set tubing empty cartridge disconnected or dislodged infusion set leak in system occlusion in system failure to complete prime poor absorption of insulin recommended actions in the cartridge: disconnect and re-prime your infu...

  • Page 170: Therapy-Related Issues

    Therapy-related issues many additional factors, such as alcohol consumption, medications other than insulin, ineffective or expired insulin, decreased activity, illness and stress can also potentially affect blood glucose levels. Contact your doctor or healthcare team for recommendations on how to m...

  • Page 171: Stop

    12 life with your accu-chek spirit insulin pump 12.1 recommendations for daily use successful insulin pump therapy requires frequent self-monitoring of blood glucose levels. It is recommended to check your blood glucose at least four times a day, or as directed by your doctor or healthcare team. 12....

  • Page 172: Run

    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 . Measure your blood g...

  • Page 173: 12.2  Weather Conditions

    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. See the section 15.1 “general technical da...

  • Page 174: 12.3.1  Daily Situations

    12.3 your insulin pump and water 12.3.1 daily situations your insulin pump is protected against unintentional water contact such as splashes or rain. For deliberate contact with water like bathing (e.G. Tubs, jacuzzis or whirlpools), taking showers, swimming or any other water activities disconnect ...

  • Page 175: Stop

    12.3.2 accidental contact with water you and your insulin pump do not have to worry about accidental temporary water contact. Examples of accidental temporary water contact include: • rain, snow; • water splashes while biking, jogging, hiking and similar activities; • accidental immersions into the ...

  • Page 176: 12.3.4  Other Liquids

    12.3.4 other liquids you and your insulin pump do not have to worry about: • sweat • saliva you must check your insulin pump immediately after an accidental contact with other liquids such as: • cleaning solutions • alcohol • beverages see the section 14.2.1 “cleaning your accu-chek spirit insulin p...

  • Page 177: 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. Do not use your insulin pump in such areas...

  • Page 178: 13.2  Sports

    Do not use your insulin pump in hyperbaric chambers and in hazardous areas of any classification (such as areas where explosive or flammable gases or vapours could exists) as this might interfere with insulin delivery and/or lead to harmful situations. Your insulin pump is designed to work in normal...

  • Page 179: 14.1  System Check

    14 care of your accu-chek spirit insulin pump roche diagnostics as the manufacturer guarantees the functions of your insulin pump according to its specifications, on the condition that all servicing of your insulin pump is done and/or authorized by roche diagnostics. 14.1 system check only a well ma...

  • Page 180: Run

    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. • you visually inspect the cartridge. Make sure that the actual amount of insulin in the cartridge equals ...

  • Page 181: 14.2.2  Battery Information

    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 f...

  • Page 182: Pump.

    • there are many types of aa batteries that are not designed to provide adequate power for your insulin pump. To ensure that the battery lasts as long as possible, be sure to use alkaline or nimh (rechargeable) batteries in your accu-chek spirit insulin pump. Alkaline batteries supplied by roche dia...

  • Page 183: Storage Conditions

    181 care of your accu-chek spirit insulin pump storage conditions temperature +5 to +45 °c (+41 to +113 °f) air humidity 5 to 85 % relative air humidity barometric pressure 70 to 106 kpa (700 to 1060 mbar) 14.4 when your insulin pump is dropped dropping may harm your insulin pump and damage the seal...

  • Page 184: 14.5  Repair

    182 care of your accu-chek spirit insulin pump 14.5 repair when experiencing problems with your insulin pump, contact your local customer care area. The local customer care area can address your concerns via the telephone or internet. Your insulin pump may need to be returned to roche diagnostics wh...

  • Page 185: 14.6  Disposal

    183 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, adapte...

  • Page 186

    184.

  • Page 187: 15 Technical Data

    185 technical data 15 technical data 15.1 general technical data maximum dimensions (without adapter) weight pump casing temperature ranges* air humidity barometric pressure approx. 81 55 20 mm (3.2 2.2 0.8 inches) • an empty insulin pump: approx. 80 g (2.8 ounces) • insulin pump inclusive battery, ...

  • Page 188

    186 technical data power supply lifetime of battery data storage time delivery basal rate 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 ...

  • Page 189

    187 technical data bolus temporary basal rate maximum time for an error e4: occlusion** 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 extend...

  • Page 190

    188 maximum volume before error e4: occlusion** maximum pressure flow (delivery rate) maximum quantity delivered at a single fault condition cartridge infusion sets data transfer plastic cartridges: 3.5 u the typical volume for an error was 2.3 u. Aventis insuman infusat glass cartridges*: 6.0 u 400...

  • Page 191

    Safety system ipx8 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 ...

  • Page 192

    15.2 technical standards on electromagnetic emissions the standard concerning electromagnetic compatibility of medical equipment (iec 60601-1-2) requires the concrete specification of the cor- responding levels which refer to specified electromagnetic interferences. Guidance and manufacturer’s decla...

  • Page 193

    15.3 technical standards on electromagnetic immunity iec 60601 test level ± 6 kv contact ± 8 kv air 3 a/m 400 a/m compliance level ± 8 kv contact ± 15 kv air (iec 60601-2-24) 400 a/m (iec 60601-2-24) electromagnetic environment – guidance avoid any contact with synthetic materials. A relative humidi...

  • Page 194

    Radiated rf iec 61000-4-3 3 v/m 80 mhz to 2.5 ghz 10 v/m 80 mhz to 2.5 ghz (iec 60601-2-24) portable and mobile rf communications equipment should be used no closer to any part of the accu-chek spirit, including cables, than the rec- ommended separation distance calculated from the equation applicab...

  • Page 195

    Note 1 at 80 mhz and 800 mhz, the higher frequency range applies. Note 2 these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. A field strengths from fixed transmitters, such as base stations for ra...

  • Page 196: Aventis Glass Cartridges***

    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. The maximum deviation of the ...

  • Page 197: Bolus

    Start-up graph over the stabilization period the start-up graph shows changes in the flow rate over the stabilization time. 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 spi...

  • Page 198

    15.4 configuration parameters your insulin pump is provided by roche diagnostics with a standard configuration (factory settings). A list containing the important factory settings is added to the original insulin pump package when your insulin pump is first shipped. You may need to adapt the factory...

  • Page 199

    197 technical data basal rate – hourly basal rate + max. Tbr (hourly basal rate combined with temporary basal rate, max. Increase) – hourly basal rates increment – hourly basal rates – temporary basal rate tbr increase or decrease in increments of tbr duration tbr duration increments – basal rate pr...

  • Page 200

    Display orientation display contrast user menus volume (for beeps) alarm signals turned on battery type keylock automatic off alarm clock time format date format typical range available on the pump and standard parameter settings* standard or inverted presetting: standard 7 steps presetting: medium ...

  • Page 201: 16 Annexes

    199 annexes 16 annexes 16.1 abbreviations approx. Approximately br basal rate brp basal rate profile ddm diabetes data management h hour(s) iec international electrotechnical commission incl. Inclusive ir infrared i.U., iu international units in context with biological effectiveness of a certain ins...

  • Page 202

    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 200 annexes.

  • Page 203: 16.2  Beeps and Melodies

    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 a each press of s each press of d , respectively confirmation of each programm...

  • Page 204: 16.3  Vibrations

    16.3 vibrations your insulin pump communicates alerts and errors using beeps and 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 ...

  • Page 205: 16.4  Symbols

    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...

  • Page 206: Ipx8

    204 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 see electronic device of type bf according the standard iec 60601-1. Protection against electrical shock. Symbol for protection against the effect ...

  • Page 207: 16.4.2  Display Symbols

    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 change the cartridge menu, and cartridge content cartridge low wa...

  • Page 208

    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 b...

  • Page 209

    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 up key down key timeout of ...

  • Page 210: 16.5.1  Sterile Products

    16.5 sterile products and accessories 16.5.1 sterile products cartridges accu-chek infusion sets name accu-chek rapidlink accu-chek tenderlink accu-chek flexlink accu-chek rapid-d link comments all accu-chek infusion sets are available in various tubing and needle lengths. Talk with your doctor and/...

  • Page 211: 16.5.2 Accessories

    209 annexes 16.5.2 accessories name adapter batteries one 1.5 volt aa alkaline battery with a minimum capacity of 2500 mah. Rechargeable batteries aa nimh rechargeable batteries with a minimum capacity of 1500 mah. Battery cover carrying systems accu-chek insulin pump configuration software travel s...

  • Page 212

    210

  • Page 213: 17 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 ...

  • Page 214: Bolus

    Bolus the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and correct high blood glucose levels. The bolus amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake and your activity level. Carrying system ...

  • Page 215: Filling Aid

    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. First, the cartridge with a connected infusion set and the piston rod of your insul...

  • Page 216: Ipx8 According to Iec 60529

    Ipx8 according to iec 60529 protection against the effects of temporary immersion in water. Ingress of water in quantities causing harmful effects is not possible when the device is temporarily immersed in water under standardized conditions (maximal 60 minutes a day and 2.5 meters [8 feet]). Luer-l...

  • Page 217: Stop

    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). Functions such as extended bolus ...

  • Page 218

    216.

  • Page 219: 18 Index

    217 index 18 index accessories . . . . . . . . . . . . . . . 35 accu-chek insulin pump configuration software . . . . 44, 78 adapter . . . . . . . . . . . . . . . . . . . 39 advanced user menu . . . . 78, 121 advanced setup menu . . . . . . 134 alarm . . . . . . . . . . . . . . . . 31, 110 alarm clo...

  • Page 220

    218 daily totals history . . . . . . . . . 116 data interrupted . . . . . . . . . . . 163 data memory . . . . . . . . . . . . . 114 data transfer . . . . . . . . . . . . . . 141 interruption of . . . . . . . . . . 141 setting up . . . . . . . . . . . . . 142 date . . . . . . . . . . . . 114, 116, 11...

  • Page 221

    219 index maintenance . . . . . . . . . . . . . . 179 malfunction. . . . . . . . . . . . . . . . 37 reusing single-use materials mechanical error. . . . . . . . . . . 158 memory . . . . . . . . . . . . . . . . . 114 menu . . . . . . . . . . . . . . . . . . . . 76 3 different . . . . . . . . . . . . ...

  • Page 222

    220 tbr; see “temporary basal rate”. . . . . . . . . . . . . . . . 102 temporary basal rate . . . . . . . 102 cancelled . . . . . . . . . . . . . . 150 decrease . . . . . . . . . . . . . . 102 duration . . . . . . . . . . . 104, 117 history . . . . . . . . . . . . . . . . 117 increase . . . . . . . ...

  • Page 223

    221 program profile no. 5 program profile no. 4 program profile no. 3 program profile no . 2 standard bolus stop your accu-chek “scroll” stan- dard bolus bolus amount extended bolus bolus amount bolus duration temporary basal rate percentage duration select the user menu user menu br profile no.… in...

  • Page 224

    19 alert overview in all cases, turn off and confirm the alert prior to addressing the issue. 223 no alert a1 cartridge low a2 battery low a3 review time and date a4 alarm clock a5 pump timer a6 tbr cancelled a7 tbr over a8 bolus cancelled what you have to do change cartridge before it is completely...

  • Page 226

    04540344001 /v 0 5 /04.07 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 www.Accu-chek.Com swiss made.