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Accu-Chek insulin pump, User Manual

The Accu-Chek insulin pump is a cutting-edge device designed to enhance the management of diabetes. It delivers precise doses of insulin, offering flexibility and convenience. For detailed guidelines on usage, refer to the free user manual available for download at our website.

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Setup for Data Transfer

Follow the steps below:

1.

Put your pump in 

STOP

mode.

2.

Press 

d

to move to the COMMUNICATION screen.

3.

Press

f

. The DATA TRANSFER screen appears and a melody signals that

your pump is ready to deliver data.

When the data transfer is finished, press 

f

to return to the 

STOP

screen.

Set up your pump with a cartridge, adapter, and a new infusion set and put
it in the 

RUN

mode, if necessary.

communi-

cation

STOP

screen 

start data

transfer 

stop data transfer

Chapter 5: User Menus

ACCU-CHEK Spirit Insulin Pump

105

ACCU-CHEK Spirit Insulin Pump

105

Summary of Contents for insulin pump

Page 1: ...Pump User Guide ACCU CHEK Spirit insulin pump ...

Page 2: ... talk to your doctor or healthcare team to decide the best way for you It s a good idea to inform family members or friends about diabetes and pump therapy so that they can help you in an emergency Disetronic Medical Systems is proud to help you manage your diabetes therapy However Disetronic Medical Systems cannot recommend specific diabetes therapy Always follow the instructions given to you by ...

Page 3: ... to best manage your insulin pump therapy Warnings and Cautions Read all warnings and cautions in this guide before you use the pump This information is important to protect your health and the function of your pump If you have any questions about a warning or caution contact Pump Support at 1 800 688 4578 Warnings and Cautions are indicated by triangles CAUTIONS are indicated by a triangle and th...

Page 4: ...d control the pump s functioning The pump performs more than nine million safety checks every day If your pump detects a change from its normal state an alert or an error message is delivered See the sections Alerts and Errors page 147 and Appendix A Technical Data page 165 for information on how to address errors and alerts Intended use of your ACCU CHEK Spirit insulin pump The ACCU CHEK Spirit i...

Page 5: ...es or modifications to the ACCU CHEK Spirit insulin pump that are not expressly approved by Disetronic Medical Systems Inc could void the pump warranty Do not try to fix the device yourself ACCU CHEK Spirit Insulin Pump 4 ...

Page 6: ... and Date____________________________________32 Your Personal Settings ___________________________________35 Your Basal Rate Profile ___________________________________36 Programming Your Basal Rate Profile________________________37 Preparing the Cartridge___________________________________42 Connecting the Cartridge Adapter and Infusion Set_____________47 Inserting the Cartridge _________________...

Page 7: ..._______________________________105 Reviewing Pump Data ___________________________________107 SETUP MENU Standard __________________________________113 ADVANCED User Menu___________________________________122 Basal Rate Profiles _____________________________________123 Alarm Clock___________________________________________127 SETUP MENU Advanced__________________________________129 CUSTOM User Men...

Page 8: ...endix C Abbreviations _______________________________180 Appendix D Beeps and Melodies __________________________181 Appendix E Vibrations __________________________________182 Appendix F Symbols____________________________________183 Appendix G Sterile Products and Accessories ________________188 Appendix H Glossary ___________________________________190 Warranty _________________________________...

Page 9: ...ACCU CHEK Spirit Insulin Pump 8 This page left blank intentionally ...

Page 10: ...ou will be aware of important changes in your pump Check your insulin pump and its sterile products like an infusion set and accessories at least every three hours Immediately inspect your insulin pump if it is dropped Do not use your insulin pump if chips or cracks are visible Chips and cracks may allow water dust insulin or other foreign substances to enter your insulin pump and lead to malfunct...

Page 11: ...tion by 180 and adjust the display contrast lighter or darker See the sections Display Orientation page 120 and Display Contrast page 135 for more information If you discover incomplete characters numbers or symbols on the display put your insulin pump into STOP mode and perform a system check by simply removing the battery for a few seconds When you reinsert the battery the system check will occu...

Page 12: ...g a setting moving forward in the information screens turning on the backlight s Down decreasing a setting moving backward in the information screens Never press any of the keys with a sharp or pointed item such as the tip of your fingernail This could damage the casing of your insulin pump Use the pad of your fingertip instead to avoid puncturing the keys Chapter 1 Understanding Your New System A...

Page 13: ...oving backwards to a previous menu d s unlocking the keys press and hold both keys until you hear three beeps in RUN mode and one beep in STOP mode a s copying an hourly basal rate to the next hour s Note Increase or decrease the values by pressing the a or s keys If you want to make large changes to a value in most cases you can do this faster by pressing and holding down the a or s key scrolling...

Page 14: ...nto your body based on the basal rate you have programmed The RUN screen is the home screen and is displayed when the pump is in RUN mode After you program or review information the pump returns to the RUN screen This screen shows the current time the current basal rate profile and the current hourly basal rate in units per hour The RUN screen will also display reminder information such as cartrid...

Page 15: ...the pump in STOP mode when you prime the infusion set and or when you transfer data See the section Stopping Insulin Delivery page 66 for instructions on stopping your pump QUICK INFO Screen If you press the f key from the RUN or STOP screen your pump displays the remaining cartridge content in units Symbols for activated functions and features like the beep and vibration alarm signals are display...

Page 16: ...to change After you reach the last function screen you will loop back to the first function screen 5 Press f to save your changes The pump returns to the RUN or STOP screen and the changes are saved STATUS Screen Messages Beeps and Vibrations Beeps vibrations and messages on the display inform you of the status of your insulin pump Beeps and or vibrations are used as alarm signals Your insulin pum...

Page 17: ...to STOP mode and when a battery is inserted The STOP Warning is a long beep and a vibration occurring every minute This warns you that insulin delivery has been interrupted To Turn Off the STOP Warning Press either a or s for 3 seconds to turn off the STOP Warning A melody plays indicating the STOP Warning is turned off Note The volume of the STOP Warning cannot be changed It is independent of the...

Page 18: ...our pump Do not use a sterile product if the package is damaged or opened Sterility is guaranteed up to the indicated expiration date for all ACCU CHEK sterile products that are in the original unopened packaging Your insulin pump was designed for use with U100 insulin Only use sterile products and accessories that are designed for use with your insulin pump The proper functionality of your insuli...

Page 19: ...ling filling needle with protective cap cartridge cartridge protective cap plunger rod plunger Your insulin pump and its sterile products and accessories include small component pieces that could pose a choking hazard to children Keep sterile products and accessories out of the reach of children Always have extra sterile products and accessories with you This allows you to exchange components when...

Page 20: ...ge in your insulin pump through the infusion set into your body The cannula or needle of the infusion set is placed under the skin usually in the abdominal area The cartridges are sterile products intended for single use only Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump 19 Recommended Possible WARNING ...

Page 21: ... range of lengths from 60 cm 24 inches to 110 cm 43 inches Choose your tubing length based on how you wear your pump Please refer to the infusion set instructions for proper usage and priming volumes Adapter The adapter connects the cartridge to the infusion set It has two seals to keep water from getting into the cartridge compartment Two vents on the adapter allow air pressure to equalize The ad...

Page 22: ...affected by how you use your insulin pump your personal settings delivery rates temperature and other factors With typical pump use 50 U day using U100 insulin operating temperature 72 F 6 F 22 C 3 C pump battery life is about four weeks using alkaline batteries and one week using rechargeable batteries Using batteries other than those recommended by Disetronic Medical Systems may significantly re...

Page 23: ...ure that you remove the battery if your insulin pump is not in use for a long time period in order to preserve the battery lifetime To prevent water from entering the casing change the battery only in a dry area Make sure that the seal of the battery cover is not worn out or missing and that the battery is properly inserted Note You must set the battery type to match the kind of battery you are us...

Page 24: ...se of an emergency so that you can exchange parts if you need to An emergency kit might contain A new ACCU CHEK infusion set A new AA alkaline battery A new ACCU CHEK 3 15 ml plastic cartridge A pen or syringe for alternate therapy A vial of insulin A filling aid Treatment for low blood glucose levels Blood glucose monitoring supplies such as an ACCU CHEK blood glucose monitor A disinfectant for s...

Page 25: ...Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump 24 This page left blank intentionally ...

Page 26: ...is properly inserted Tighten or loosen the battery cover with the ACCU CHEK Spirit insulin pump battery key 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 The battery cover is correctly inserted and tightened when the battery cover is level with the insulin pump casing Keep the Time Date Sett...

Page 27: ...livered 3 Remove the battery cover Use the battery key to turn the battery cover as indicated by the arrow on the battery cover Make sure that the opening of the battery compartment and the seal are clean and undamaged Remove the old battery if necessary 4 Put the battery cover on the positive end of the battery Hold the cover on the positive end of the battery and insert the battery negative end ...

Page 28: ...ontacts within your insulin pump Therefore using batteries not recommended by Disetronic Medical Systems may void the warranty Do not insert old or used batteries into your insulin pump as this may cause a failure at the insulin pump start up Note If your pump was in RUN mode before you removed the battery an error E8 POWER INTERRUPT will occur when a new battery is inserted Press f twice to confi...

Page 29: ... safety system monitors it continuously If the safety system detects a change from the normal state an alert warning instruction or an error error message occurs Do not interrupt the start up process by pressing keys or by handling the insulin pump Interruption of the start up process may lead to malfunctions of your insulin pump If your insulin pump does not beep and vibrate as described or if in...

Page 30: ...the vibration alert you may not be notified of any changes of your insulin pump in a suitable amount of time If you cannot feel the vibration alert contact Pump Support at 1 800 688 4578 If you cannot hear the beeps from your insulin pump you may not be notified of changes with your insulin pump in a suitable amount of time If you cannot hear the beeps contact Pump Support at 1 800 688 4578 Chapte...

Page 31: ...the error or alert at this point See the section Alerts and Errors page 147 for more information 11 A melody signals the end of the start up process and the pump shows the STOP screen The STOP Warning occurs every minute by giving a long beep and a vibration to remind you that no insulin is being delivered in STOP mode Press and hold a or s until you hear a melody to turn the STOP Warning off Chap...

Page 32: ...ls remain your insulin pump may need to be returned since you may not receive the correct information for operating your pump Put your insulin pump into STOP mode and contact Pump Support at 1 800 688 4578 immediately Note If the voltage of the battery is too low the start up procedure cannot finish Your pump beeps five tones and keeps restarting the start up procedure until you remove the battery...

Page 33: ...correct insulin delivery and data memory Do not make therapy decisions based upon a single result in the insulin pump s memory If you your doctor or healthcare team reviews your therapy data electronically it is essential that the time and date of your insulin pump your blood glucose measurement system such as an ACCU CHEK blood glucose meter the PC and other devices used are set identically If th...

Page 34: ...f to select 2 The SET HOUR screen displays Press a or s to set the hour 3 Press d to move to the SET MINUTE screen Press a or s to set the minutes set the hour set the time and date RUN screen set the minute set the year set the month set the day Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 33 ...

Page 35: ...a or s to set the year 5 Press d to move to the SET MONTH screen Press a or s to set the month 6 Press d to move to the SET DAY screen Press a or s to set the day 7 Press f to save and exit Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 34 ...

Page 36: ...orrect programming of your insulin pump may cause incorrect insulin delivery 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 them Work with your doctor or healthcare team to determine the timing as well as the amount and type of bolus you need to deliver Ma...

Page 37: ...rit insulin pump basal rate profile consists of up to 24 different hourly basal rates Each hourly rate may be changed independently The total of all 24 hourly basal rates in one basal rate profile is called the daily basal rate total Your basal rate profile should be reviewed after any programming changes are made to your pump after a new battery is inserted and after confirming an error E7 ELECTR...

Page 38: ... changes you made before your insulin pump times out will not be saved daily basal rate total program profile 1 RUN screen 1st hour 2nd hour 24th hour Note Insulin delivery does not stop or pause during basal rate programming The insulin amounts and other values used in this user guide are examples only Your personal values may differ Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 37 ...

Page 39: ... 01 00 AM if the American time format is used is shown 4 Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team 5 Press d to move to the next hour 6 Continue using d and the a and s keys to set the hourly basal rates for the remaining hours This lets you program your individual basal rate profile hour by hour Continue until all 24 hours are programmed Chapter 2...

Page 40: ...ive immediately Note At any screen you have three options to exit If you want to save the changes Press f Check the new daily basal rate total Press f Your pump returns to the RUN screen If you want to undo the changes Wait for your ACCU CHEK Spirit insulin pump to return to the RUN screen timeout or Press d a simultaneously exit feature to exit the function screen Chapter 2 Getting Started ACCU C...

Page 41: ...PROFILE 1 screen 2 Press f to select The daily BASAL RATE TOTAL is displayed 3 Press d to move to the hourly basal rate you want to copy 4 Press a s simultaneously A special beep confirms that you are pressing the keys correctly The same hourly basal rate is copied to the next hour 5 If you want to copy the rate to multiple hours press a s repeatedly or press and hold a s scroll Chapter 2 Getting ...

Page 42: ...ed basal rate A bolus can be programmed when it is needed A bolus is 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 as well as stress and illness See the section Understanding...

Page 43: ...ion date Do not use sterile products if the package is damaged Do not reuse single use materials Reusing single use materials might lead to a malfunction of your insulin pump and to incorrect insulin delivery and or an infection Always handle the items with clean hands Use specified cartridges only Using other cartridges can endanger your health and may void the warranty Chapter 2 Getting Started ...

Page 44: ...low 1 Wash your hands 2 Set the insulin vial on a hard flat surface such as a table Clean the rubber membrane of the vial using an antiseptic wipe Note A filling aid an optional accessory by Disetronic Medical Systems helps you fill an empty ACCU CHEK 3 15 ml plastic cartridge from your vial of insulin Read the instructions that are included with the filling aid to learn how to use it Chapter 2 Ge...

Page 45: ...ack and forth twice in the cartridge to distribute the lubricant Pull the plunger back to fill the cartridge with air 5 Remove the protective cap from the needle Do not touch anything with the needle Push the tip of the filling needle into the center of the insulin vial s rubber membrane Push the plunger rod down so that all air from the cartridge enters the insulin vial Plunger rod Plunger Chapte...

Page 46: ... not pull or push the plunger rod while it is moving on its own this could lead to air bubbles in the insulin Slowly pull the plunger rod straight down to fill the cartridge Remove any air bubbles by tapping on the cartridge Push the air bubbles back into the insulin vial using the plunger rod The cartridge is full when there are no air bubbles in it and the plunger is at the bottom of the cartrid...

Page 47: ...ead of insulin In this case your body does not receive the required amount of insulin and an error E4 OCCLUSION may be displayed Remove bubbles while filling the cartridge and priming the infusion set and without having the infusion set connected to your body Cold insulin may release air when warmed Use only insulin at room temperature when filling the cartridge and priming the infusion set Inspec...

Page 48: ...an infection Always handle the items with clean hands Avoid any contact of the infusion set and the connecting parts of your insulin pump with antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics They may contaminate these parts Note Before you change the cartridge adapter and infusion set check that your pump is in good working order See the section System I...

Page 49: ...at least every three hours during the day and before you go to sleep If you detect any loss of insulin and all parts are correctly tightened immediately replace the leaking component Because insulin delivery has been interrupted check your blood glucose level and take appropriate actions according to your doctor s or healthcare team s instructions To avoid leakage properly tighten the infusion set...

Page 50: ...ge STOP screen returning piston rod cartridge volume 315 units start up procedure prime the infusion set 3 sec Do not perform the CHANGE THE CARTRIDGE function if the cartridge compartment is not completely dry During the rewinding of the piston rod insulin or water might enter your insulin pump and could lead to malfunction If necessary use a soft cloth to dry the compartment Chapter 2 Getting St...

Page 51: ... screen 4 Press f to select Remove the current cartridge if there is one 5 Press and hold f for 3 seconds until you hear a melody The piston rod begins its return Do not touch or disturb the piston rod while it is rewinding Doing so may potentially damage your pump When the piston rod returns completely the CARTRIDGE VOLUME screen displays the maximum cartridge volume 315U Chapter 2 Getting Starte...

Page 52: ... pointing upwards Insert the cartridge into the cartridge compartment 9 Twist do not push the adapter clockwise until it sits flush with the cartridge compartment It is not necessary to apply pressure Twisting will properly position the cartridge Do not over tighten the adapter or it will be difficult to remove the cartridge adapter and cartridge plunger and may potentially cause damage to your pu...

Page 53: ...te of the piston rod sits flush against the cartridge plunger 10 Press f after correctly inserting the cartridge Your pump performs a self test See the section System Check Start Up Process page 28 11 Check that the infusion set luer lock connector is still correctly connected to the adapter Tighten the infusion set by hand clockwise until it sits tightly in the adapter 12 When the system check st...

Page 54: ...the infusion set Air bubbles in the cartridge and infusion set may cause the infusion of air instead of insulin If this happens your body will not receive the required amount of insulin 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 bubbles while filling the cartridge and priming the infusion set and without ha...

Page 55: ...splays the STOP screen and insulin delivery stops 3 Prepare the tubing or cannula needle for priming per infusion set instructions for use 4 Press d to move to the PRIME THE INFUSION SET screen start priming start up procedure stop priming STOP screen prime the infusion set 3 sec Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 54 ...

Page 56: ...ay Your pump stops priming after 25 units When the priming process is finished your pump returns to STOP The infusion tubing set is properly primed when there are no air bubbles visible in the tubing and a drop of insulin has come out of the connector or cannula Stopping the Priming Process You can stop the priming process at any time by pressing any key Your pump displays the STOP PRIMING screen ...

Page 57: ...on sites bruises and sores Choose an infusion site at least one inch 2 5 cm away from the navel and previous infusion sites Infusion Site Preparation It is important to prepare the infusion site properly to reduce the risks of infection Your doctor or healthcare team will give you infusion site preparation guidelines Have the following materials ready Your ACCU CHEK Spirit insulin pump A disinfect...

Page 58: ...3 Disinfect the infusion site and let it dry completely 4 Make sure your pump is in STOP mode 5 Insert your ACCU CHEK infusion set according to the instructions for its use Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 57 ...

Page 59: ...d infusion site immediately and contact your doctor or healthcare team Change your infusion headset according to the instructions for the infusion set you are using and your doctor or healthcare team s recommendations Note If you use a soft cannula type infusion set you must proceed with a bolus to fill the air space in the cannula after removing the introducer needle according to the instructions...

Page 60: ...ith your ACCU CHEK Spirit insulin pump The proper functioning of your pump can only be guaranteed if you use it with ACCU CHEK Spirit insulin pump accessories See Disetronic Medical Systems sterile products and accessories catalogs and brochures for more information Or contact Pump Support at 1 800 688 4578 When wearing your insulin pump make sure to prevent any contact with objects that may damag...

Page 61: ...itions Do not place your insulin pump in direct sunlight Overheating of the insulin and your insulin pump must be avoided Protect your insulin pump from direct exposure to cold wind and temperatures over 104 F 40 C and below 41 F 5 C These conditions may damage the insulin and the electronics of your insulin pump and may cause a malfunction of the battery See the instructions for the insulin you a...

Page 62: ...itoring devices such as those in department stores should not affect the functioning of your pump Because there are so many devices such as cellular phones that give out electromagnetic radiation the influence of some such devices on your pump cannot be ruled out It is a good idea to keep your pump at least 4 inches 10 cm away from such devices while the other devices are turned on Do not use your...

Page 63: ...ts brochures and accessories catalog for more information regarding carrying systems or contact Pump Support at 1 800 688 4578 for more information Traveling Ask your doctor or healthcare team about any special actions you need to take before you travel Take extra blood glucose testing and pump supplies when you travel and find out where to get supplies while you are traveling When you travel acro...

Page 64: ...ntal short term water contact Examples of accidental short term water contact include rain snow water that splashes while you are biking jogging or hiking accidental brief immersion into the sink or bathtub 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 In the presen...

Page 65: ...dry See the section Cleaning Your ACCU CHEK Spirit Insulin Pump page 141 for more information Other Liquids You do not have to worry about contact between your pump and sweat saliva You must check your pump immediately after contact with other liquids or chemicals such as cleaning solutions alcohol beverages See the section Cleaning Your ACCU CHEK Spirit Insulin Pump page 141 for more information ...

Page 66: ... of insulin remaining in the cartridge at least once a day If you press the f key from the RUN or STOP screen your pump displays the remaining cartridge content in units Before going to sleep make sure that the cartridge contains enough insulin to last through the night and the time and date are set correctly start your ACCU CHEK STOP screen RUN screen Chapter 3 Using Your Pump ACCU CHEK Spirit In...

Page 67: ...t and priming the infusion set Follow the steps below 1 Press d to move to the STOP YOUR ACCU CHEK screen 2 Press f to select Your pump returns to the STOP screen and insulin delivery stops 3 Press f QUICK INFO screen to review activated functions and features like the beep and vibration alarm signals indicated by icons and messages on the screen When your insulin pump is in STOP mode it does not ...

Page 68: ... to turn off the STOP Warning A melody plays indicating the STOP Warning is turned off Note The volume of the STOP Warning cannot be changed It is independent of the programmed beep volume Note When an Extended Bolus a MultiWave Bolus and or a Temporary Basal Rate TBR is are active and you put your pump into STOP mode an alert A6 TBR CANCELLED and or an alert A8 BOLUS CANCELLED occur s Press f twi...

Page 69: ...eserve in the body If insulin is interrupted for any reason such as if you stop the pump there is a technical problem with the pump there is leakage in the cartridge there is occlusion in the infusion tube set or in the infusion headset the cannula has slipped out of the infusion site you must be ready to replace the missing insulin immediately Always carry spare sterile products and accessories i...

Page 70: ...rapy to check the function of the system and to ensure insulin delivery Interruption of Use of Your Insulin Pump for a Long Period of Time There may be times when you may need to interrupt your pump therapy for more than one day Follow the steps below 1 Put your pump into STOP mode 2 Remove the cartridge adapter and infusion set 3 Reinsert the adapter 4 Remove the battery and reinsert the battery ...

Page 71: ...et leakage You must inspect all parts of your infusion set at least every three hours during the day and before you go to sleep If there seems to be any loss of insulin and all parts are correctly tightened immediately replace the leaking component Immediately check your blood glucose level because insulin delivery has been interrupted Take appropriate actions according to your doctor s or healthc...

Page 72: ...e adapter and dispose of it properly 5 Carefully prepare a new ACCU CHEK infusion set for use 6 Turn the ACCU CHEK infusion set by hand clockwise into the adapter 7 Properly tighten the luer lock connector by hand Note The battery key has a notch that fits all ACCU CHEK infusion set luer lock connectors You may use the battery key to loosen the luer lock connector between your infusion set and ada...

Page 73: ...h a bolus to fill the air space in the cannula after removing the introducer needle according to the instructions for the infusion set you are using Failure to do so could result in missed insulin dosing See the section Programming a Standard Bolus page 77 for more information Inspect your infusion site at least once or twice each day for irritation or infection Signs of infection may include but ...

Page 74: ...ection A new adapter must be changed at least with every 10th cartridge 1 Wash your hands thoroughly 2 Make sure your insulin pump is in STOP mode 3 Remove your infusion tube set from the headset 4 Remove the infusion tube set from the adapter and dispose of it properly Note The battery key has a notch that fits all ACCU CHEK infusion set luer lock connectors You may use the battery key to loosen ...

Page 75: ...the adapter at least every 10th insulin cartridge change 9 If needed clean the adapter using water and dry it If it shows signs of wear or dirt replace it immediately 10 Install a new cartridge and a new infusion set See the following sections for instructions Changing the Infusion Set page 70 Preparing the Cartridge page 42 Connecting the Cartridge Adapter and Infusion Set page 47 Inserting the C...

Page 76: ...our blood glucose level your food intake your health condition and your activity level Discuss the timing and the amount and type of bolus you need with your doctor or healthcare team You can review the time date and amount of the last 30 boluses in the bolus history See the section Review the Bolus History page 107 for more information Your pump can deliver three types of boluses Standard Bolus f...

Page 77: ...ump 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 Work with your doctor or healthcare team to determine the timing amount and type of bolus you need to deliver Make sure you know your personal carbohydrate to insulin ratio a...

Page 78: ... and turn off the alert See the section Alert A8 BOLUS CANCELLED page 153 for more information Programming a Quick Standard Bolus The following process involves only the a and s keys You can start with either key The recommended steps below are those described with the first key appearing without parenthesis such as a For the alternative step press the key in the parenthesis such as s Note Because...

Page 79: ...total bolus amount with one beep and vibration for each bolus increment programmed The Standard Bolus symbol blinks for 5 seconds the bolus delivery start delay After this bolus delivery start delay the pump beeps three times and then begins to deliver the total bolus amount programmed The countdown of the remaining bolus amount appears on the display Hint Start programming with the a key in areas...

Page 80: ...n alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert See the section Alert A8 BOLUS CANCELLED page 153 for more information No bolus is delivered during bolus delivery countdown of bolus amount Press and hold s or a for 3 seconds until you hear a melody An alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert Bolus delivery is interrupted See ...

Page 81: ...dless of the bolus increment setting the bolus increments for the Scroll Standard Bolus are fixed to 0 1 unit You can program this bolus in the STANDARD BOLUS screen by holding the a or s key scrolling until the bolus amount is displayed Follow the steps below 1 Press d to move to the STANDARD BOLUS screen 2 Press f to select The BOLUS AMOUNT screen appears 3 Press or scroll a to increase or s to ...

Page 82: ...US menu by pressing d a simultaneously Set the bolus amount to 0 0 units Press f to exit No bolus is delivered during the start delay is blinking Press s or a A melody plays Your pump returns to the RUN screen An alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert No bolus is delivered Please refer to section Alert A8 BOLUS CANCELLED page 153 for more information during...

Page 83: ...ion by looking at the bolus history Please refer to the section Review the Bolus History page 107 for more information Make sure that the cancellation was intended and then program a new Standard Bolus if needed Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump 82 ...

Page 84: ...ry can be programmed in 15 minute intervals up to 24 hours and begins immediately after confirmation bolus amount Extended bolus RUN screen bolus duration stop your ACCU CHEK A8 bolus cancelled Note You can add a Standard Bolus to an ongoing Extended Bolus If you cancel the Standard Bolus the Extended Bolus continues to run During the delivery of an Extended Bolus the programming of another Extend...

Page 85: ...or when using your pump for the first time a default value appears 4 Press d to move to the BOLUS DURATION screen Press a to increase or s decrease the bolus duration 5 Press f to confirm the bolus amount and duration You will hear a melody when the bolus delivery begins within the next 3 minutes Note Press d to loop between programming the bolus amount and bolus duration Chapter 4 Boluses and TBR...

Page 86: ...ring 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 At any function screen you have three options to exit If you want to deliver the bolus Press f Your pump returns to the RUN screen If you want to cancel the bolus Wait for your pump to return to the RUN screen timeout or Press d a simultaneously ...

Page 87: ...egun it can be cancelled by putting your pump into STOP mode 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 Alert A8 BOLUS CANCELLED page 153 for more information Bolus delivery is interrupted The bolus amount delivered up to the cancellation can be reviewed in the BOLUS HISTORY screen See the section Review th...

Page 88: ... mode An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press f twice to confirm and turn off the first alert The second alert appears on the display Press f twice to confirm and turn off the second alert Both alerts are recorded in the alarm history See the sections Alert A6 TBR CANCELLED page 152 and Alert A8 BOLUS CANCELLED page 153 for more information Chapter 4 Boluses and TBRs ...

Page 89: ... bolus delivery can be programmed in 15 minute intervals for up to 24 hours Note The MultiWave Bolus is available in the ADVANCED user menu You can add a Standard Bolus to an ongoing MultiWave Bolus If you cancel the Standard Bolus the MultiWave Bolus remains running During the delivery of a MultiWave Bolus the programming of a second MultiWave Bolus or an Extended Bolus is blocked If you need a d...

Page 90: ...amount The first time you press a the bolus duration of the last MultiWave Bolus appears except when you are using your pump for the first time in which case a default value appears As you increase or decrease the total bolus amount the suggested immediate bolus amount increases or decreases proportionally bolus delivery bolus amount MultiWave bolus RUN screen immediate bolus bolus duration 5 sec ...

Page 91: ...the display The set values can be viewed in the BOLUS AMOUNT IMMEDIATE BOLUS and BOLUS DURATION screens 8 Press f to confirm both bolus amounts and the bolus duration The MultiWave Bolus symbol blinks for 5 seconds bolus delivery start delay The pump beeps three times and the immediate bolus delivery begins The countdown of the remaining bolus continues to appear on the display Note Press d to loo...

Page 92: ...irm and turn off the alert No bolus is delivered See the section Alert A8 BOLUS CANCELLED page 153 for more information during bolus delivery You can cancel the immediate delivery by pressing and holding s or a for 3 seconds until you hear a melody This cancels the whole bolus immediate and Extended Bolus delivery An alert A8 BOLUS CANCELLED occurs Note Once the immediate bolus is delivered the re...

Page 93: ...orary Basal Rate is active at the same time it is also cancelled when your pump is put in STOP mode An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press f twice to confirm and turn off the first alert The second alert appears on the display Press f twice to confirm and turn off the second alert Both alerts are recorded in the alarm history See the sections Alert A6 TBR CANCELLED p...

Page 94: ...or 0 the basal rate profile becomes a flat curve and no insulin except boluses is delivered during the programmed duration Discuss programming a Temporary Basal Rate with your doctor or healthcare team Note A running Temporary Basal Rate increase or decrease remains active even if you changed the basal rate profile Incorrect programming of your insulin pump may cause incorrect insulin delivery You...

Page 95: ...creen appears 4 Press a or s to increase or decrease the basal rate Note If no Temporary Basal Rate is currently active the percentage is set to 100 If a Temporary Basal Rate is active its duration and percentage appear on the RUN screen precentage temporary basal rate RUN screen duration Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump 94 ...

Page 96: ...to undo the changes Wait for your pump to return to the RUN screen timeout or Press d a simultaneously exit feature to exit the function screen Set volume to 100 and press f Note Press d to loop between programming the basal rate percentage and duration Note When you increase or decrease the Temporary Basal Rate the duration of your previous Temporary Basal Rate increase or decrease appears When y...

Page 97: ...s and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen Note During the Temporary Basal Rate delivery the increase or decrease in percentage the increased or decreased hourly basal rate hourly basal rate plus TBR percentage and the remaining time are displayed in the RUN screen An arrow pointing up symbolizes a Temporary Basal Rate increase an arrow pointin...

Page 98: ... the TBR percentage to 100 Press f to save and exit No Temporary Basal Rate is delivered during delivery There are two ways to cancel a Temporary Basal Rate during delivery Set the TBR percentage to 100 1 Press d to move to the TEMPORARY BASAL RATE TBR screen 2 Press f to select The TBR PERCENTAGE screen appears 3 Press a or s to return the basal rate to 100 Press f to save and exit Or put your pu...

Page 99: ...CELLED occur Press f twice to confirm and turn off the first alert The second alert appears on the display Press f twice to confirm and turn off the second alert Both alerts are recorded in the alarm history See the sections Alert A6 TBR CANCELLED page 152 and Alert A8 BOLUS CANCELLED page 153 for more information When your insulin pump is in STOP mode it does not deliver any insulin Put your insu...

Page 100: ...NCED user menu The ADVANCED User Menu This menu offers the full range of the ACCU CHEK Spirit insulin pump functions It includes all functions from the STANDARD user menu plus a wide range of functions for the more experienced user The CUSTOM User Menu Because the ACCU CHEK Spirit insulin pump has many features you may want to choose the screens that you see when you scroll through the menu choice...

Page 101: ...een Press f to select Note When you change the user menu your current basal rate profile will not appear if it is not activated Make sure that your desired basal rate profile number s is are activated This can be done through the previous user menu or the ADVANCED user menu user menu select the user menu RUN screen select basal rate profile 100 ...

Page 102: ... 3 Press f to confirm The selected basal rate profile and its daily insulin total appear or if the previous basal rate profile is not available from the selected user menu dashes appear instead 4 Press a or s to select a basal rate profile if needed Check the new basal rate profile and its daily insulin total 5 Press f to save and exit The new user menu and basal rate profile are active immediatel...

Page 103: ...o undo the changes press d a simultaneously to exit the function screen or Wait for your pump to return to the RUN screen timeout A running increased or decreased Temporary Basal Rate will remain active even if you changed the basal rate profile The temporary basal rate is based on the new basal rate Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 102 102 CAUTION ...

Page 104: ...asal Rate Profile page 37 CHANGE THE CARTRIDGE See the section Inserting the Cartridge page 49 PRIME THE INFUSION SET See the section Priming the Infusion Set page 53 START YOUR ACCU CHEK See the section Starting Insulin Delivery page 65 STOP YOUR ACCU CHEK See the section Stopping Insulin Delivery page 66 STANDARD BOLUS See the section Programming a Standard Bolus page 77 EXTENDED BOLUS See the s...

Page 105: ...mp events about 90 days of usage Pump events include alerts and errors programming operations and insulin delivery records Some or all of the pump memory may be transferable to compatible software The built in infrared interface inside the bottom cover of your insulin pump allows for wireless data transfer ...

Page 106: ...signals that your pump is ready to deliver data When the data transfer is finished press f to return to the STOP screen Set up your pump with a cartridge adapter and a new infusion set and put it in the RUN mode if necessary communi cation STOP screen start data transfer stop data transfer Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 105 ACCU CHEK Spirit Insulin Pump 105 ...

Page 107: ...FER screen is selected You may press d a simultaneously to exit while data is being transferred The data transfer is interrupted and an error E12 DATA INTERRUPTED occurs See the section Error E12 DATA INTERRUPTED page 163 for more information Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 106 ...

Page 108: ...in days until the pump timer expires Review the Bolus History The bolus history lets you review up to the last 30 boluses delivered beginning with the most recent entry and working backward in time Each BOLUS HISTORY screen displays the bolus type Standard Bolus Extended Bolus or MultiWave Bolus bolus duration only displayed if an Extended or a MultiWave Bolus time date and entry number 01 is the ...

Page 109: ...US HISTORY screen appears The most recent bolus information is displayed 3 Press a or s to review the entries Press f to exit information menu RUN screen alarm history daily total TBR history maintenance bolus history Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 108 ...

Page 110: ...er and type of the alert or error example A6 alert or error example TBR CANCELLED time date and entry number 01 is the most recent of total entries example 01 30 of an alert or error 1 Press d to move to the INFORMATION screen Press f to select 2 Press d to move to the ALARM HISTORY screen 3 Press a or s to review the entries Press f to exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 109 ...

Page 111: ...ach daily insulin total screen displays the following history daily total of insulin delivered its date and entry number 01 is the most recent of total entries example 01 30 of a daily insulin total Follow the steps below 1 Press d to move to the INFORMATION screen Press f to select 2 Press d to move to the DAILY TOTALS screen 3 Press a or s to review the entries Press f to exit Chapter 5 User Men...

Page 112: ...splays the TBR increase or decrease in percentage TBR duration time date and entry number 01 is the most recent of total entries example 01 30 of a delivered Temporary Basal Rate Follow the steps below 1 Press d to move to the INFORMATION screen Press f to select 2 Press d to move to the TBR HISTORY screen 3 Press or scroll a or s to review the entries Press f to exit Chapter 5 User Menus ACCU CHE...

Page 113: ... new one The pump timer symbol appears in the RUN screen or STOP screen as a reminder When the timer expires an error occurs and your pump goes into STOP mode It can no longer be put into RUN mode See the sections Alert A5 PUMP TIMER page 151 and Error E5 END OF OPERATION page 158 for more information Review the number of days left until the pump timer expires in the INFORMATION menu Follow the st...

Page 114: ...TUP MENU Standard menu choice Turning KeyLock On or Off The KeyLock function lets you lock the four keys of your pump and serves as an extra safety measure against activating functions by accident for example while sleeping during contact sports To use the KeyLock function it must be turned on See the section Keys and Key Combinations page 11 for more information setup standard RUN STOP screen Key...

Page 115: ...MENU STANDARD screen Press f to select 2 The current KeyLock status ON or OFF appears 3 Press a or s to turn the KeyLock ON or OFF Press f to save and exit If no key is pressed for 10 seconds after your pump has returned to the RUN screen or STOP screen and if the KeyLock is turned on all four keys are locked ...

Page 116: ...old for 3 seconds until you again hear three beeps in RUN mode one beep in STOP mode to confirm that the KeyLock is unlocked 2 If no key is pressed for 10 seconds after your pump has returned to the RUN or the STOP screen all four keys are automatically locked RUN screen locked RUN screen unlocked 10 sec 3 sec Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 115 ...

Page 117: ...ps beeps are turned off very low low normal maximum 4 Press f to save and exit Note The volume of the STOP Warning is independent of the programmed beep volume It always occurs at the maximum level When the beeps are turned off and an alert or error occurs the beeps will become active again after a short period of time to make sure that you are aware of the alarm or error These beeps will steadily...

Page 118: ...r pump to alert you when an alarm occurs You have three options beep only vibrate only beep and vibrate Follow the steps below 1 Press d to move to the SETUP MENU STANDARD screen Press f to select 2 Press d to move to the ALARM SIGNALS screen The active alarm signals are displayed 3 Press a or s to set the alarm signals 4 Press f to save and exit ...

Page 119: ...the SETUP MENU STANDARD screen Press f to select 2 Press d to move to the AUTOMATIC OFF screen The current status is displayed at the bottom left of the screen 3 Press or scroll a to increase or s to decrease the duration for the automatic off in 1 hour intervals 4 If you would like to set the automatic off function to OFF press or scroll s until 0 hours and OFF appears on the display 5 Press f to...

Page 120: ...ies Follow the steps below 1 Press d to move to the SETUP MENU STANDARD screen Press f to select 2 Press d to move to the BATTERY TYPE screen The current battery type is displayed 3 Press a or s to select the battery type ALKALINE or NiMH rechargeable battery Press f to save and exit If you do not set the correct battery type on your insulin pump the alert A2 BATTERY LOW may not occur in time to p...

Page 121: ...ntly depending on how you are wearing the pump Follow the steps below 1 Press d to move to the SETUP MENU STANDARD screen Press f to select 2 Press d to move to the ORIENTATION screen 3 Press a or s to select the display orientation 4 Press f to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 120 ...

Page 122: ... the display orientation the upper key will be the a and the lower key will be s This change applies for all a and s functions including turning on the backlight The d and f will not change in their function but will remain the same regardless of your screen orientation Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 121 CAUTION ...

Page 123: ...the ADVANCED user menu Some of the functions have already been discussed earlier in the manual The remaining functions are described below EXTENDED BOLUS See the section Programming an Extended Bolus page 83 MULTIWAVE BOLUS See the section Programming a MultiWave Bolus page 88 CHANGE BASAL RATE PROFILE See the section Selecting a Basal Rate Profile page 125 PROGRAM BASAL RATE PROFILE See the secti...

Page 124: ...al rate profiles to match your changing insulin needs for example Monday Friday versus Exercise Day versus Sleeping Late Day Discuss additional basal rate profiles with your doctor or healthcare team Consult with your doctor or healthcare team before changing basal rate profiles as this may change how you use your pump ...

Page 125: ...al rate profiles that are accessible in your current user menu are available Incorrect programming of your insulin pump may cause incorrect 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 ex...

Page 126: ...d 3 Press a or s to select a basal rate profile The selected basal rate profile and its daily insulin total appear 4 Press f to select The new basal rate profile is active immediately Note Only basal rate profiles that are accessible in your current user menu are available BR profile no change the BR profile RUN screen Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 125 ...

Page 127: ...mber s you want does not appear Select the ADVANCED user menu or Program the basal rate profile to an available basal rate profile number A running Temporary Basal Rate increase or decrease stays active even if you change the basal rate profile on your pump Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 126 ...

Page 128: ... or other important events Set Single or Multiple Alarms 1 Press d to move to the ALARM CLOCK screen 2 Press f to select The current alarm clock status OFF ONCE or EVERY DAY and alarm time appear 3 Press a or s to change the alarm clock to OFF ONCE or EVERY DAY 4 Press d to move to the SET ALARM HOUR screen Press a or s to set the hour 5 Press d to move to the SET ALARM MINUTE screen Press a or s ...

Page 129: ...When the alarm clock goes off an alert A4 ALARM CLOCK occurs Press f twice to confirm and turn off the alert See the section Alert A4 ALARM CLOCK page 151 for more information Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 128 ...

Page 130: ...ettings can be changed using the SETUP MENU Advanced menu choice Time Format You can set the time in either of the following formats American 12 hour clock AM PM example 1 39 PM European Military 24 hour clock 00 00 23 59 example 13 39 Follow the steps below 1 Press d to move to the SETUP MENU ADVANCED screen Press f to select 2 The TIME FORMAT screen appears Press a or s to select a time format 3...

Page 131: ...6 European dd mm yyyy example 26 04 06 Follow the steps below 1 Press d to move to the SETUP MENU ADVANCED screen Press f to select 2 Press d to move to the DATE FORMAT screen Press a or s to select a date format 3 Press f to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 130 ...

Page 132: ... at a constant 0 1 units See the section Programming a Standard Bolus page 77 for more information Follow the steps below 1 Press d to move to the SETUP MENU ADVANCED screen Press f to select 2 Press d to move to the BOLUS INCREMENT screen Press a or s to select a bolus increment 3 Press f to save and exit The bolus increment that can be programmed into your insulin pump determines the Quick Stand...

Page 133: ... 25 units of U100 insulin Follow the steps below 1 Press d to move to the SETUP MENU ADVANCED screen Press f to select 2 Press d to move to the PRIME QUANTITY screen Press a or s to select a prime quantity between 0 0 and 30 0 units 3 Press f to save and exit Note The amount of insulin used for the priming is not added to the history of daily insulin totals You can press any of your pump s keys to...

Page 134: ...ve to the BASAL RATE LOCK screen Press a or s to turn the basal rate lock ON or OFF 3 Press f to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 133 Note If the basal rate lock is set to ON the programming of the basal rate profiles 1 2 3 4 and 5 is blocked To check if the basal rate lock is ON press d to move to the PROGRAM BASAL RATE screen and press f to select The symbol in th...

Page 135: ...Portuguese Czech Dutch Swedish Norwegian Polish and Greek To choose a language do the following 1 Press d to move to SETUP MENU ADVANCED screen Press f to select 2 Press d to move to the LANGUAGE screen Press a or s to select a language 3 Press f to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 134 ...

Page 136: ... Follow the steps below 1 Press d to move to the SETUP MENU ADVANCED screen Press f to select 2 Press d to move to the DISPLAY CONTRAST screen Press a or s to select a contrast level 3 Press f to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 135 ...

Page 137: ...user menu All of these functions have been addressed in detail in STANDARD and ADVANCED user menu sections STANDARD BOLUS EXTENDED BOLUS TEMPORARY BASAL RATE TBR INFORMATION CHANGE BASAL RATE PROFILE PROGRAM BASAL RATE PROFILE 1 PROGRAM BASAL RATE PROFILE 2 ALARM CLOCK SET DATE AND TIME SETUP MENU STANDARD SELECT USER MENU Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 136 ...

Page 138: ...mp display at least every three hours during the day and before you go to sleep and especially if for any reason you might not be able to hear the beeps or to feel the vibrations Use only sterile products and accessories designed to be used with your pump Replace and discard these items according to your doctor s or healthcare team s recommendations and the instruc tions that come with these items...

Page 139: ...r is correctly tightened and positioned even with the pump casing The adapter is inserted properly Your infusion set is primed free of air bubbles and tight in the adapter Your infusion set is inserted according to the instructions for its use Your infusion site is secure comfortable and free of irritation or infection The cartridge is free of air bubbles Your pump is in RUN mode The basal rates a...

Page 140: ... still tight and if they are not reconnect or tighten them Check your pump its sterile products and accessories for chips and cracks and Change the cartridge if it is damaged If you have questions or are not sure whether your pump has been damaged contact Pump Support at 1 800 688 4578 Check your insulin pump and its sterile products and accessories at least every three hours Immediately inspect y...

Page 141: ...r insulin pump return it to Disetronic Medical Systems for professional disposal Battery Properly dispose of dead batteries Cartridge Infusion Set Adapter and Accessories Dispose of these items in your normal garbage Remember to dispose of the introducer needle safely needle container To prevent injury to others replace the needle protective cap or insert the needle of the infusion set into a disp...

Page 142: ...emperature 72 F 6 F 22 C 3 C pump battery life is about four weeks using alkaline batteries and one week using rechargeable batteries See the section Accessories and Disposables Battery page 21 for more information on recommended batteries See the section Inserting or Changing the Battery page 25 for instructions on how to change your battery Always remove the cartridge and adapter and place your ...

Page 143: ...portation Place your pump back in the shipping case and put the case in a package that will not rip or tear It is best to send your pump using a shipping method and carrier that tracks the shipment When you return your pump include the following a description of the reason for returning your pump your name and address your daytime phone the serial number of your pump and any RMA Return Material Au...

Page 144: ...or or healthcare team Always follow your doctor s or healthcare team s recommendations and contact them if you have any concerns about your insulin pump therapy You need to know that the interruption of insulin delivery due to a leak occlusion or loss of insulin potency for example or the malfunction of your insulin pump can result in a rapid rise of your blood glucose level Although your pump has...

Page 145: ...IC ERROR Incorrect insulin delivery due to incorrect time setting Incorrect insulin delivery due to incorrect basal rate programming Recommended Actions Contact Pump Support at 1 800 688 4578 Check that the beep volume and alarm signals are turned on Check and change the battery If your insulin pump still does not beep or vibrate contact Pump Support at 1 800 688 4578 Remove the battery wait a few...

Page 146: ... room temperature In the infusion set Disconnect and prime your infusion set Reconnect and make sure all connections are tight and secure Change your infusion set and infusion site Replace the cartridge Cartridges are for single use only Make sure all connections are tight Inspect connections for leaking insulin Check your blood glucose level Change your infusion set and infusion site Check for le...

Page 147: ...ntil a bubble free insulin flow emerges from the tip of the needle Make sure the tubing is free of air Choose infusion sites that do not have scar tissue bruises or tissue build up Do not use the same infusion set or infusion site longer than your doctor or healthcare team recommends Change your infusion headset and infusion site immediately Use proper insertion technique Check blood glucose level...

Page 148: ...ither the beeps or the vibrations but for your safety you cannot turn off both at the same time for the initial alarm signal If you do not confirm an alert or error within 60 seconds it will signal again When the beep is turned off or programmed at lower than maximum volume level the beep volume will rise to the loudest volume level if not confirmed The beep and vibration will continue at this lev...

Page 149: ...ent memory Follow the steps below to confirm an alert or error 1 Press f to turn off the beeps and vibrations The alert or error code stays on the display 2 As soon as you understand the reason for the alert error code or message confirm by pressing f again 3 Take the appropriate action if any 4 If more than one alert and or error occurs simultaneously press f twice for each alert or error to conf...

Page 150: ...artridge 1 Press f twice to turn off and to confirm the alert Change the cartridge before it is empty 2 If necessary put your pump in RUN mode See the section Changing the Cartridge and Infusion Set page 73 for more information After an alert occurs your insulin pump may be in STOP mode and the insulin delivery may be interrupted In order to maintain insulin delivery you must act immediately accor...

Page 151: ...sposables Battery page 21 for more information on recommended batteries See the section Inserting or Changing the Battery page 25 for instructions on how to change your battery Alert A3 REVIEW TIME AND DATE The pump was without power for more than one hour The ACCU CHEK Spirit insulin pump settings and history data are saved in memory regardless of power loss However it may be necessary to enter t...

Page 152: ...iod of four years of running time After the alert A5 PUMP TIMER occurs the ACCU CHEK Spirit insulin pump will display the symbol to remind you to check the timer 1 Press f twice to turn off and to confirm the alert 2 Put your pump in RUN mode 3 Go to the INFORMATION screen on your pump Note If you have set the alarm occurrence to EVERY DAY the same alert occurs every 24 hours Turn the alarm clock ...

Page 153: ...mation Alert A6 TBR CANCELLED Temporary Basal Rate Cancelled A temporary increase or decrease of the basal rate has been cancelled 1 Press f twice to turn off and to confirm the alert 2 If necessary put your pump in RUN mode 3 Make sure that the cancellation was intended and then program a new Temporary Basal Rate if needed Note The alert A5 PUMP TIMER ALERT and the error E5 END OF OPERATION are b...

Page 154: ...l Rate Alert A8 BOLUS CANCELLED A bolus was cancelled during the start delay or after delivery began 1 Press f twice to turn off and to confirm the alert 2 If necessary put your pump in RUN mode 3 Make sure that the cancellation was intended and then program a new bolus if needed Note The actual bolus amount that was delivered before the cancellation can be reviewed in the bolus history See the se...

Page 155: ...set 4 Reconnect the infusion set at your infusion site 5 Put your pump in RUN mode See the section Changing the Cartridge and Infusion Set page 73 for more information After the occurrence of an error your insulin pump will be in STOP mode 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 C...

Page 156: ...ur pump stores the settings you saved before the battery power ran out If your pump is without power for more than one hour check the time and date After inserting a new battery always check 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 your doctor or healthcare team store and analyze your therap...

Page 157: ... of this error depends on several factors including your current hourly basal rate and boluses For example a blocked infusion set with a basal rate of 2 0 U h U100 insulin and no additional boluses would trigger an error E4 OCCLUSION in approximately three hours or less depending on the type and severity of the blockage If an error E4 OCCLUSION occurs immediately check your blood glucose level and...

Page 158: ...t your pump in RUN mode In rare cases the cartridge itself can be the cause of the occlusion If an error E4 OCCLUSION occurs again you must change the cartridge Follow the steps below 1 Press f twice to turn off and to confirm the error 2 Disconnect or remove the infusion set from your infusion site 3 Change the cartridge and prime the infusion set 4 Reconnect the infusion set tubing at your infus...

Page 159: ...apter and infusion set 6 Prime the infusion set 7 Reconnect the infusion set tubing at your infusion site 8 Put your pump in RUN mode If the error E4 OCCLUSION continues to occur contact your doctor or healthcare team for an alternate therapy plan Contact Pump Support at 1 800 688 4578 for more assistance Error E5 END OF OPERATION Your pump timer has reached zero The pump will change to STOP mode ...

Page 160: ...or 2 Remove or disconnect the infusion set from your infusion site 3 Remove the cartridge adapter infusion set tubing and battery from your pump Insert a new battery 4 Rewind the piston rod 5 Install a new cartridge and infusion set 6 Prime the infusion set 7 Reconnect the infusion set tubing at your infusion site 8 Put your pump in RUN mode Note The alert A5 PUMP TIMER ALERT and the error E5 END ...

Page 161: ...pressing f You must remove the battery instead 1 Remove or disconnect the infusion set from your infusion site 2 Insert a new battery into the pump 3 Prime the infusion set 4 Reconnect the infusion set tubing at your infusion site 5 Put your pump in RUN mode If an error E7 ELECTRONIC ERROR occurs during programming i e basal rate time and date check your settings If the error E7 ELECTRONIC ERROR o...

Page 162: ... goes in STOP mode 3 Check the time and date and correct them if they are wrong See the section Setting Time and Date page 32 for more information 4 If a bolus and or a Temporary Basal Rate was interrupted by the error review the bolus and or the Temporary Basal Rate history for the delivered amount and duration See the section Reviewing Pump Data page 107 for instructions 5 Put your pump in RUN m...

Page 163: ...rs during the winding of the piston rod insert a new battery into the pump and repeat steps 1 6 Error E11 SET NOT PRIMED The cartridge was changed but the infusion set was not primed The error will display when you try to put your pump in RUN mode Never prime an infusion set that is connected to your body You risk uncontrolled insulin delivery into your body With detachable infusion sets make sure...

Page 164: ... Data transfer between your pump and a PC was interrupted before it was completed 1 Press f twice to turn off and to confirm the error 2 Restart the data transfer Before you can put your pump in RUN mode the data transfer must be successful If data transfer between compatible software and your insulin pump is disrupted in any way the configuration may be incomplete and an error E12 DATA INTERRUPTE...

Page 165: ...ROR The language setting needs to be checked 1 Press f twice to turn off and to confirm the error 2 Follow the steps in the section SETUP MENU Advanced Language page 134 to change the language 3 Put your pump in RUN mode Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump 164 ...

Page 166: ... case 700 to 1 060 mbar do not exceed 10 000 feet 3 000 meters above sea level Basal rate Minimum 0 1 U h maximum 25 U h There are 24 hourly basal rates adjustable in 0 1 unit increments Battery life If used in a typical usage pattern 50 U day using U100 insulin operating temp of 72 F 6 F 22 C 3 C the battery life is approx four weeks for alkaline and one week for rechargeable batteries Appendixes...

Page 167: ... luer lock connection Data storage time The time and date is safely stored in the memory for about 1 hour after the battery has been removed Your insulin pump s settings the hourly basal rates remaining cartridge content bolus increments and active user menu and the event memory bolus history history of daily insulin totals Temporary Basal Rate history alarm history are saved regardless of battery...

Page 168: ...um volume before error U100 insulin 3 5 U Maximum pressure 400kPa 4 0 bar Maximum quantity delivered at U100 insulin 1 0 U a single fault condition Power supply One 1 5 volt AA Alkaline battery or one rechargeable Nickel Metal Hydride NiMH AA battery Alkaline batteries should have a minimum capacity of 2500 mAh and NiMH AA rechargeable batteries a minimum capacity of 1500 mAh Use only a battery ch...

Page 169: ...ctly The brushless motor also constitutes an important safety component It provides the best possible reliability and accuracy in insulin delivery Temperature ranges During operation 41 F to 104 F 5 C to 40 C Stored in its shipping case 41 F to 113 F 5 C to 45 C Temporary Basal Rate Adjustable in 10 increments 0 90 for decreases 110 200 for increases The duration is adjustable in 15 minute interva...

Page 170: ... The ACCU CHEK Spirit insulin pump uses RF CISPR11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The ACCU CHEK Spirit insulin pump is CISPR11 suitable for use in establishments including domestic establishments and those directly connected to the public low voltage power...

Page 171: ...ngth in the location in which the ACCU CHEK Spirit insulin pump is used exceeds the applicable RF compliance level above the ACCU CHEK Spirit insulin pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ACCU CHEK Spirit insulin pump b Over the frequency range 150 kHz to 80 MHz field strengt...

Page 172: ... 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment Guidance Electrostatic 6 kV contact 8 kV contact Avoid any contact with discharge ESD 8 kV air 15 kV air synthetic materials A IEC 61000 4 2 IEC 60601 2 24 relative humidity of 10 will allow ESD to be more likely Power frequency 3 A m 400 A m 400 A m Power frequency magnetic 50 60Hz fields should be at levels magnetic fie...

Page 173: ...n distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 0 4 E s P 80 MHz to 800 MHz d 0 7 E s P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as de...

Page 174: ... delivery rate in relation to the observation period The measurements were made at a medium basal rate of 1 0 U h according to IEC 60601 2 24 1998 with a Disetronic Classic infusion set PC 16 110 at room temperature The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is 5 Appendixes ACCU CHEK Spirit Insulin Pump 173 ...

Page 175: ...rding to IEC 60601 2 24 1998 with a Disetronic Classic infusion set PC 16 110 at room temperature Influence of height on delivery accuracy The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is 10 when your ACCU CHEK Spirit insulin pump is located 3 3 feet 1 m above below the level of infusion site Appendixes ACCU CHEK Spirit Insulin Pump 174 ...

Page 176: ... period The measurements were made at a medium basal rate of 0 1 U h according to IEC 60601 2 24 1998 with a Disetronic Classic infusion set PC 16 110 at room temperature The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is 20 Appendixes ACCU CHEK Spirit Insulin Pump 175 Appendixes ACCU CHEK Spirit Insulin Pump 175 ...

Page 177: ...infusion set PC 16 110 at room temperature Bolus For U100 insulin the delivery accuracy of a maximum bolus is 5 and the delivery accuracy of a minimum bolus is 30 The measurements were made according to IEC 60601 2 24 1998 with a Disetronic Classic infusion set PC 16 110 at room temperature Delivery Mode Delivery Rate Volume Accuracy Range Basal 0 1 U h 20 0 08 0 12 U h Bolus 0 1 U 30 0 07 0 13 U ...

Page 178: ...first shipped You may need to adapt the factory settings to meet your individual needs Set the configuration parameters directly on your insulin pump Always consult your doctor or healthcare team before changing parameters The list on the next two pages gives you the full range for the adjustable configuration parameters on your pump Also included are examples of typical range and parameter settin...

Page 179: ...e 100 0 200 TBR increase or decrease 10 10 in increments of TBR duration max 24 h 15 min 24 h TBR duration increments 15 min 15 min 30 min 1 h basal rate profiles available 5 1 5 basal rate lock off on or off Bolus bolus amount per U100 25 0 IU h Insulin Type Max Amount bolus delivery U100 0 25 0 U bolus amount increments 0 5U 0 1 0 2 0 5 1 0 or 2 0 U for Quick and Scroll Standard Bolus bolus dura...

Page 180: ...lume for beeps maximum off 1 4 steps Alarm signals turned on beeps and vibrations beeps vibrations or both Battery type AA battery AA Alkaline or AA NiMH rechargeable battery KeyLock off turned on or off Automatic off off turned on or off 0 1 24h Alarm clock off turned on or off when on once or every day s occurrence Time format American 12 h am pm or European 24 h Date format American mm dd yy or...

Page 181: ...D Liquid Crystal Display LED Light Emitting Diode for infrared communication with for example a personal computer PC NiMH Nickel Metal Hydride used with rechargeable batteries rel Relative sec Second s TBR Temporary Basal Rate U see I U U h Amount of International Units of insulin delivered per hour U100 Each milliliter of liquid contains 100 International Units of insulin mm dd yy American date f...

Page 182: ... programming a Quick Standard Bolus Each press of confirms the STOP Warning Temporary Basal Rate is active Unlock the KeyLock in RUN mode enter the RUN or INFO screen start a Temporary Basal Rate Lock the KeyLock in RUN mode Unlock the KeyLock in STOP mode enter STOP screen Lock the KeyLock in STOP mode Exit a screen Cancel a running bolus or stop priming Start up procedure successful Copy an hour...

Page 183: ...r ACCU CHEK Spirit insulin pump vibrates when l Short vibration Your ACCU CHEK Spirit insulin pump performs a start up procedure Medium vibration Your ACCU CHEK Spirit insulin pump confirms the programmed bolus amount of the Quick Standard bolus Long vibration You reset the Quick Standard Bolus amount to zero you cancel the Quick Standard Bolus or when the STOP Warning occurs See the sections Prog...

Page 184: ...d 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 handle with care Protect against moisture Appendixes ACCU CHEK Spirit Insulin Pump 183 ...

Page 185: ...dard IEC 60601 1 Protection against electrical shock Symbol for protection against the effect of temporary immersion in water up to 60 minutes and 2 5 meters 8 feet according to IEC 60529 Marking of conformity according to the European Medical Device Directive MDD 93 42 EEC with the number of the notified body Federal law USA restricts this device to sale by or on the order of a physician Federal ...

Page 186: ... is turned on Unlocked keys when the KeyLock function is turned on Change the cartridge menu and cartridge content Cartridge low warning Empty cartridge Low battery Empty battery Alkaline AA battery Rechargeable AA battery Amount of International Units of insulin delivered per hour Basal rate profile Temporary Basal Rate TBR percentage Daily basal rate total Basal rate programming unlocked Basal r...

Page 187: ...maining duration of an ongoing Extended Bolus MultiWave Bolus TBR or automatic off Daily total of insulin delivered basal rate plus boluses Prime the infusion set menu Alert or error occurring Alert Error Information menu Pump timer Select the user menus STANDARD ADVANCED or CUSTOM SETUP MENU STANDARD menu SETUP MENU ADVANCED menu Beeps turned on Vibrations turned on Beeps and vibrations turned on...

Page 188: ...te format Alarm clock turned on Alarm clock turned off Single alarm when setting an alarm clock Every day repeat alarm when setting an alarm clock PC communication Set beep volume Check key Up key Down key Timeout of a menu Appendixes ACCU CHEK Spirit Insulin Pump 187 ...

Page 189: ...age and handling ACCU CHEK infusion sets Name Comments ACCU CHEK Ultraflex The ACCU CHEK Ultraflex infusion set has a specially tapered cannula and reversible connector for easy comfortable insertion and wearing convenience ACCU CHEK Tender Variable insertion angle and choice of cannula for maximum control and comfort ACCU CHEK Rapid D Ultra fine stainless needle inserts easily with one hand and i...

Page 190: ...or alkaline Rechargeable Battery If used in a typical usage pattern One AA NiMH rechargeable battery with 50 U day using U100 insulin a minimum capacity of 1500 mAh operating temp of 72 F 6 F 22 C 3 C the battery life is approx one week for rechargeable batteries Battery Cover Replace your battery cover with every 4th battery Carrying Systems Disetronic Medical Systems offers a wide range of carry...

Page 191: ...and on the weekend A basal rate profile consists of 24 programmed hourly basal rates Basal rate total The sum of all 24 hourly basal rates in one basal rate profile is called the daily basal rate total 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...

Page 192: ...l an empty ACCU CHEK 3 15 ml plastic cartridge from your vial of insulin Free flow Free flow of insulin from the infusion set may occur when two conditions are met first if the cartridge with a connected infusion set and the piston rod of your pump are not correctly coupled and second if you position your pump at a higher level than the infusion site Headset also known as cannula housing The part ...

Page 193: ...tting at the end of the infusion set the cartridge and the adapter that lets them be locked together without leaking Personal settings Your pump must be programmed with your personal settings prior to starting insulin pump therapy Personal settings include the basal rate profile s the correct time and date and all other variable values that can be tailored to your individual needs on your pump RUN...

Page 194: ...lus or Temporary Basal Rate are interrupted by putting your pump into STOP mode STOP screen The STOP screen is the starting point for all functions that require that your pump does not deliver insulin Temporary Basal Rate Temporary increase or decrease of your basal rate profile in percentages from 0 200 to match changing insulin needs due to increased or decreased activity level illness or stress...

Page 195: ...LTS FROM CHANGES OR MODIFICATIONS MADE TO THE INSULIN PUMP BY THE USER OR THIRD PERSONS AFTER THE DATE OF MANUFACTURE 2 IF DAMAGE RESULTS FROM SERVICE OR REPAIRS PERFORMED BY ANY PERSON OR ENTITY OTHER THAN DISETRONIC 3 IF DAMAGE RESULTS FROM A FORCE MAJEURE OR OTHER EVENT BEYOND THE CONTROL OF DISETRONIC OR 4 IF DAMAGE RESULTS FROM NEGLIGENCE OR IMPROPER USE INCLUDING BUT NOT LIMITED TO IMPROPER ...

Page 196: ... 187 Bolus 75 Extended 83 87 History 107 108 MultiWave 88 92 Quick Standard 77 80 Scroll Standard 80 82 Index Cartridge 9 18 Changing 73 74 Connecting 47 48 Filling 43 46 Inserting 49 52 Low 149 185 CHECK Key 9 187 Cleaning 141 Copying Hourly Basal Rate 40 41 Data Interrupted 163 Data Transfer 104 Date 32 34 150 Date Format 130 Daily Insulin Totals 110 191 Display 9 10 Contrast 135 Orientation 120...

Page 197: ...iWave Bolus Programming 88 91 Cancelling 91 92 Occlusion 146 Error 156 158 167 Orientation 120 Power Interrupt 161 Prime Quantity 132 Priming 53 55 Products Sterile 17 18 188 Profile See Basal Rate Profile Programming Additional Basal Rate Profile 124 Basal Rate Profile 37 Extended Bolus 83 87 MultiWave Bolus 88 92 Quick Standard Bolus 77 80 Scroll Standard Bolus 80 82 Temporary Basal Rate 93 96 P...

Page 198: ... mode E4 OCCLUSION Immediately check your blood glucose level because insulin delivery has been interrupted If your blood glucose level is high take appropriate actions according to your doctor s or healthcare team s instructions See the section Error E4 OCCLUSION E5 END OF OPERATION Arrange for immediate replacement of your insulin pump Contact Pump Support at 1 800 688 4578 to dis cuss your opti...

Page 199: ...rtridge remove the cartridge fill volume 315 units start up procedure start your Accu Chek KeyLock quick info start your Accu Chek stop priming prime the infusion set start priming communi cation data transfer to PC returning the piston rod change the cartridge remove the cartridge fill volume 315 units start up procedure A Quick with direct access from the RUN screen Standard bolus using the a an...

Page 200: ...4632753001 V01 11 05 Swiss made Manufactured by Disetronic Medical Systems AG CH 3401 Burgdorf Switzerland Distributed by Disetronic Medical Systems Inc 11800 Exit 5 Parkway Suite 120 Fishers IN 46037 Phone 866 703 3476 Fax 888 810 0758 For technical assistance call Pump Support at 800 688 4578 www accu chek com ...

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