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Accu-Chek insulin pump User's Manual

1. T STANDAR DISPLAY 4 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump If you flip the display orientation of your insulin pump by 180 the and keys will also reverse their CAUTION functions In comparison to the display orientation the upper key will be the amp and the lower key will be This change applies for all gt and functions including turning on the backlight The gt and 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 ADVANCED User Menu The ADVANCED user menu offers the full range of the ACCU CHEK Spirit insulin pump functions The ADVANCED user menu includes all functions from the STANDARD user menu plus a wide range of functions for the more experienced user The following is a list of additional menu choices that appear in 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 section Programming Additional Basal Sate Profiles page 124 ALARM CLOCK See the section A
2. see the sections Alert A6 TBR CANCELLED page 152 and Alert A8 BOLUS CANCELLED page 153 for more information Make sure that the cancellation was intended and then program a new MultiWave Bolus and or Temporary Basal Rate if needed Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Programming a Temporary Basal Rate TBR Your pump lets you temporarily increase or decrease your basal rate This lets you match changing insulin needs from increased or decreased activity level illness or stress n Incorrect programming of your insulin pump may cause incorrect insulin delivery Your insulin pump must be WARNING 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 if you are less experienced have your doctor or healthcare team check your personal settings Typically a basal rate is set to 100 but you can e Increase it to 200 for up to 24 hours e Decrease it to 0 for up to 24 hours When you increase or decrease your basal rate each hourly basal rate for the duration you program is increased or decreased The characteristic shape of your basal rate profile remains and does not become a flat curve if the change is larger than 0 For 0 the basal rate profile becomes a flat curve and no insulin except boluses is delivered during the programmed
3. Boluses and TBRs ACCU CHEK Spirit Insulin Pump You can view the actual bolus amount delivered prior to the cancellation by looking at the bolus history See 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 Programming a Menu Guided Scroll Standard Bolus Regardless 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 or key scrolling until the bolus amount is displayed Follow the steps below 1 Press G to move to the STANDARD BOLUS screen STAHDARD BOLUS L 2 Press to select The BOLUS AMOUNT screen appears BOLUS AMOLIAT 0 00 3 Press or scroll to increase or to decrease the bolus amount BOLUS AMOQUMT val 4 Press to confirm the bolus amount Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump The Standard Bolus symbol _L blinks for five seconds the bolus delivery start delay After this bolus delivery start delay your pump beeps three times and begins to deliver the total bolus amount programmed The countdown of the remaining bolus amount appears on the display Cancelling a Menu Guided Scroll Standard Bolus during programming the bolus amount blinks You have three options
4. Programming a Standard Bolus page 77 EXTENDED BOLUS See the section Programming an Extended Bolus page 83 TEMPORARY BASAL RATE TBR See the section Programming a Temporary Basal Rate TBR page 93 COMMUNICATION See the section Data Transfer page 104 INFORMATION See the section Reviewing Pump Data page 107 SETUP MENU STANDARD See the section SETUP MENU Standard page 113 SELECT USER MENU See the section Selecting a User Menu page 100 Chapter 5 User Menus 3 ACCU CHEK Spirit Insulin Pump Data Transfer The pump memory stores up to 4 500 pump 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 Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump setup for Data Transfer communi cation STOP GD screen Follow the steps below 1 Put your pump in STOP mode Gid2Prl m asv26 ETO 2 Press G to move to the COMMUNICATION screen COMMUHICAT I Or 3 Press GA The DATA TRANSFER screen appears and a melody signals that your pump is ready to deliver data DATA TRAHSFER Fok il When the data transfer is finished press to return to the STOP screen Set up your pump wi
5. comfortable and free of irritation or infection e The cartridge is free of air bubbles e Your pump is in RUN mode e The basal rates are set correctly according to your doctor s or healthcare team s recommendations e The time and date are set correctly e The Temporary Basal Rate changes are set according to your doctor s or healthcare team s recommendations e The beeps and or vibrations are set e You have your personal emergency kit Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump What to Do When You Drop Your Pump lf the pump is dropped it could be harmed or the seal that protects it against water could be damaged Be careful not to drop your pump Use the proper ACCU CHEK Spirit insulin pump carrying system to help avoid dropping your pump See Disetronic Medical Systems sterile products and accessories catalogs and brochures for more information Or contact Pump Support at 1 800 688 4578 If your pump is dropped e Check that all connections in your infusion set are still tight and if they are not reconnect or tighten them e Check your pump its sterile products and accessories for chips and cracks and e Change the cartridge if it is damaged Check your insulin pump and its sterile products and accessories at least every three hours Immediately inspect CAUTION your insulin pump if it is dropped Do not use your insulin pump if chips or cracks are visible Chips and cracks may allow wat
6. for more information Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Error E2 BATTERY DEPLETED The battery is out of power Replace it immediately After inserting a new battery always check that the time and date of your insulin pump are set correctly Incorrect WARNING programming of the time and date may cause incorrect insulin delivery If you your doctor or healthcare team store and analyze your therapy data electronically and the time and date of the devices used are not set identically the gathered data might not be meaningful 1 Press twice to turn off and to confirm the error 2 Replace the battery 3 Put your pump in RUN mode Note Your pump stores the settings you saved before the battery power ran out If your pump is without power for more than one hour check the time and date 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 Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Error E3 AUTOMATIC OFF Automatic off is a safety feature that stops insulin delivery and triggers an error E3 AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode 1 Press G amp A twice to turn off and to confirm the error AUTOMATIC OFF _ fy gmi PLEASE CONFIRM
7. system Inspection Checklist Your pump must be well maintained to guarantee accurate insulin delivery Check the pump 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 Chapter 6 Care and Maintenance 37 ACCU CHEK Spirit Insulin Pump Check your pump daily Make sure that e The pump casing the display and the cartridge are not chipped or cracked and that the display doesn t show incomplete or abnormal letters or symbols e You visually inspect the cartridge Make sure that the actual amount of insulin in the cartridge equals the displayed cartridge amount on the QUICK INFO screen e You inspect all parts of your pump and infusion set at least every three hours during the day and before you go to sleep If you detect any loss of insulin immediately replace the leaking component e The battery cover is correctly tightened and positioned even with the pump casing e The adapter is inserted properly e Your infusion set is primed free of air bubbles and tight in the adapter e Your infusion set is inserted according to the instructions for its use e Your infusion site is secure
8. 1 Press G to move to the ALARM CLOCK screen ALARM CLOCE a 2 Press GA to select The current alarm clock status OFF ONCE or EVERY DAY and alarm time appear ao CLOCK 12 88PP1 3 Press or to change the alarm clock to OFF ONCE 4 or EVERY DAY 9 ALARM CLOCK 12 88PM OHCE 4 Press G to move to the SET ALARM HOUR screen SET ALARM HOUR 1 12SHHPT1 Press or to set the hour 5 Press G to move to the SET ALARM MINUTE screen SET ALARM MIHUTE Press or to set the minute Om 15 12 15PM 6 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Turning Off the Alarm Clock When the alarm clock goes off an alert A4 ALARM CLOCK occurs Press gt 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 SETUP MENU Advanced The SETUP MENU Advanced should not be confused with the ADVANCED user menu The SETUP MENU Advanced is a menu choice that appears in the ADVANCED user menu The SETUP MENU Advanced allows you to set up certain features and settings The following features and settings 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 2
9. 12 When the system check start up process is finished the PRIME THE INFUSION SET screen is displayed PRIME THE IHFUSTIOM SET t See the section Priming the Infusion Set page 53 for more information Start from the point in those instructions where the pump screen matches the screen above Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Priming the Infusion Set You risk uncontrolled insulin delivery into your body Always WARNING follow the instructions for the infusion set you are using Never prime an infusion set that is connected to your body The ACCU CHEK Spirit insulin pump stops priming after 25 units of insulin If no insulin has emerged from the tube set needle after priming repeat the priming function When insulin comes from the tip of the needle press any pump key to stop priming The amount of insulin used in priming is not added to the pump s history of daily insulin totals During priming your pump should be upright with the adapter pointing upwards to help let air bubbles out of the cartridge and 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 WARNING 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
10. 2 Put your pump in RUN mode Error E4 OCCLUSION n If an error E4 OCCLUSION occurs immediately check your blood glucose level and check again in about 2 hours WARNING 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 Insulin a maximum of 3 5 units of U100 insulin was not delivered This may be due to e a blocked infusion set e a reused cartridge or e a dirty or damaged piston rod Note The display 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 Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump If the occlusion blockage was inside your infusion set follow the steps below 1 Press GA twice to turn off and to confirm the error OCCLUS 1 OH A E4 ei PLEASE COHFIFH 2 Disconnect or remove the infusion set from your infusion site 3 Change the infusion set and prime it 4 Reconnect the infusion set tubing at your infusion site 5 Put 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 car
11. 5 and the delivery accuracy of a minimum bolus is lt 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 Appendixes ACCU CHEK Spirit Insulin Pump Appendix B Configuration Parameters Your pump is built by Disetronic Medical Systems with a standard configuration factory settings A list containing the important factory settings is added to the original insulin pump package when your pump is 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 settings Appendixes ACCU CHEK Spirit Insulin Pump Typical Range and Maximum Parameter Parameter Settings Range Basal Rate hourly basal rate U100 62 5 IlU h Insulin Type Max Amount max TBR U100 0 62 50 IU h hourly basal rate combined with temporary basal rate max increase hourly basal rates 0 1 U increment hourly basal rates U100 10 01U h Insulin Type Max Amount U100 0 25 0 IU h temporary basal rate 100 0 2
12. Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump n The bolus increment that can be programmed into your insulin pump determines the Standard Bolus amount WARNING using the amp and keys of your insulin pump Incorrect programming of the bolus increment may cause inappropriate insulin delivery See the section Bolus Increment page 131 for more information Cancelling a Quick Standard Bolus during programming the bolus amount blinks e Press the key or you used to enter the Quick Standard Bolus programming option This will reset the bolus amount to 0 0 units A melody will play If no new bolus is programmed your pump returns to the RUN screen and beeps three times after five seconds No bolus is delivered during confirmation when the beeps and vibrations occur or during the start delay _ blinks e Press or A melody plays Your pump returns to the RUN screen An alert A8 BOLUS CANCELLED occurs Press 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 e Press and hold or for 3 seconds until you hear a melody An alert A8 BOLUS CANCELLED occurs Press twice to confirm and turn off the alert Bolus delivery is interrupted see the section Alert A8 BOLUS CANCELLED page 153 for more information Chapter 4
13. INFUSION SETS DURING THE WARRANTY PERIOD DISETRONIC WILL REPAIR OR REPLACE IN ITS SOLE DISCRETION ANY INSULIN PUMP THAT DOES NOT WORK PROPERLY BECAUSE OF A DEFECT IN MATERIALS OR WORKMANSHIP THE PURCHASER S SOLE AND EXCLUSIVE REMEDY WITH RESPECT TO THE INSULIN PUMP SHALL BE REPAIR OR REPLACEMENT THIS WARRANTY APPLIES ONLY TO NEW DEVICES IN THE EVENT A PUMP IS REPAIRED OR REPLACED THE WARRANTY PERIOD WILL NOT BE EXTENDED THIS WARRANTY IS VALID ONLY IF THE INSULIN PUMP IS USED IN ACCORDANCE WITH THE USER INSTRUCTIONS THIS WARRANTY WILL NOT APPLY 1 IF DAMAGE RESULTS 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 STORAGE PHYSICAL ABUSE SUCH AS DROPPING OR OTHERWISE THIS WARRANTY SHALL BE PERSONAL TO THE ORIGINAL PURCHASER ANY SALE RENTAL OR OTHER TRANSFER OR USE OF THE INSULIN PUMP COVERED BY THIS WARRANTY TO OR BY A USER OTHER THAN THE ORIGINAL PURCHASER SHALL CAUSE THIS WARRANTY TO IMMEDIATELY TERMINATE THIS WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
14. Insulin Pump Follow the steps below 1 Press amp to move to the STOP YOUR ACCU CHEK screen STOP YOUR ACC HEF Enh Press to select and put the pump in STOP mode Your pump returns to the STOP screen and insulin delivery stops 2 Remove or disconnect your infusion tube set from the headset so that insulin cannot accidentally be delivered lt aa ae C9 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 Hold the cover on the positive end of the battery and insert the battery negative end first into the battery compartment Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 5 Use the cover to gently push the battery all the way in Turn the battery cover clockwise to tighten it The battery cover is correctly tightened when the outside of it is even with the casing Do not over tighten the battery cover The pump begins its start up process 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 twice to confirm and turn off the error Check the time and date in the STOP screen and correct them if necessary See the section Setting Time and Date page 32 for instr
15. bolus which may be adjusted by simply holding down the G gt or keys will move at a constant 0 1 units See the section Programming a Standard Bolus page 77 for more information Follow the steps below 1 Press G to move to the SETUP MENU ADVANCED screen SETUP MEHU Press to select AGDWANCED 1 Ti 2 Press amp D to move to the BOLUS INCREMENT screen BOLUS INCREMENT Press or to select a bolus increment L oO 3 Press to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Prime Quantity The prime quantity needed to fill an infusion set depends on the length of the infusion set tubing being used 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 units of U100 insulin 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 stop priming Follow the steps below 1 Press G to move to the SETUP MENU ADVANCED screen SETUP MEHL Press to select ADWAMCED 2 Press G to move to the PRIME QUANTITY screen PRIME QUANTITY Press or to select a prime quantity 259 00 between 0 0 and 30 0 units 3 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Lock Basal Rate Profiles Your pump lets you change your hourly basal rates as needed You
16. delivered bolus Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump RUN information O screen menu U Ni 1 Press G to move to the INFORMATION screen IMFORMAT IOH li 2 Press amp to select BOLUS HISTORY The BOLUS HISTORY screen appears The most IL amp H1 H8 ru i So je _ recent bolus information is displayed GAPS 4P amp 11729 3 Press or to review the entries BOLUS HISTORY Press GA to exit 1 a 5u Az BS TABRSSSPhM 5 11725 Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Review the Alarm History The alarm history lets you review the last 30 alerts or errors beginning with the most recent entry and working backward in time Each alarm history screen displays the e number and type of the alert or error example A6 e alert or error example TBR CANCELLED e time e date E and e entry number 01 is the most recent of total entries example 01 30 of an alert or error 1 Press G to move to the INFORMATION screen IMFORMAT IDH Press GA to select i 2 Press G to move to the ALARM HISTORY screen pa HISTORY eS OCCLUSION D B4514PM arai 3 Press or to review the entries ALARM HISTORY Press to exit Ae 11 3 8 SET HOT PRIMED T a4 3PM AF30 Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Review the History of Daily Insulin Totals This history lets you review the last 30 daily totals of
17. has stopped If you are aware of the situation and don t wish to be reminded you can turn off the STOP Warning To Turn Off the STOP Warning Press either or 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 programmed beep volume Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Interruption of Insulin Pump Therapy Consult with your doctor or healthcare team about when and for how long your insulin pump therapy can be interrupted Measure your blood glucose level regularly during any insulin interruption Use a syringe or insulin pen to inject insulin according to the instructions of your doctor or healthcare team Since only rapid acting insulin is used for insulin pump therapy there is only a small insulin reserve in the WARNING body If insulin is interrupted for any reason such as o if you stop the pump e there is a technical problem with the pump e there is leakage in the cartridge e there is occlusion in the infusion tube set or in the infusion headset e 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 infusion set insulin cartridge batteries an insulin pen syringe and insulin Without insulin diabetic ketoacidosis may develop and may require
18. humidity such as in a sauna as this could damage your pump To make it easy to remove your pump use disconnectable ACCU CHEK infusion sets Consult your doctor or healthcare team to find out how long your insulin pump therapy can safely be interrupted Accidental Contact with Water Your insulin pump is protected against accidental short term water contact Examples of accidental short term water contact include rain snow e water that splashes while you are biking jogging or hiking e accidental brief immersion into the sink or bathtub Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump What to Do After Any Water Contact Put your pump into STOP mode Disconnect the pump from your body before inspecting it Use a soft cloth to dry the outside of the pump Check the battery compartment and the cartridge compartment for water If the battery compartment or cartridge compartment are wet turn your pump upside down to let the water run out and let it air dry Do not use warm air such as a hair dryer to dry the pump as this could damage the pump s electronics Do not re insert the battery or the cartridge until the compartments are completely 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 e sweat e saliva You must check your pump immediately after contact with other liquids or c
19. in patient hospital treatment Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Short Interruption 1 Put your pump in STOP mode 2 Remove or disconnect the infusion tube set from the infusion headset When using a disconnectable infusion set disconnect it at your infusion site and use the protective covers that came with the infusion set Resuming Insulin Pump Therapy 1 Attach a new ACCU CHEK infusion set and prime it before inserting it 2 Follow the instructions to prepare the infusion set you are using and put your pump into RUN mode Measure your blood glucose level within 2 hours of restarting pump therapy 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 Contact your doctor or healthcare team for an alternate therapy plan when you interrupt the insulin pump therapy CAUTION for a long period of time 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 cover 5 Store your pump properly See the section Storing Your ACCU CHEK Spirit Insulin Pump page 140 for more information Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Changing the Infusion Set When you change the infusion set
20. infusion set and without having the infusion set connected to your body Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump start up Sa procedure ALIMAMA primethe G2 start 3 infusion set priming priming DA STOP screen Follow the steps below 1 Press amp to move to the STOP YOUR ACCU CHEK screen STOP YOUR ACCU CHEK T 2 Press to select and put the pump in STOP mode Mi42PM i 05 26 Your pump displays the STOP screen and insulin m delivery stops 3 Prepare the tubing or cannula needle for priming per infusion set instructions for use 4 Press G to move to the PRIME THE INFUSION SET screen PRIME THE IHFUSTIOM SET 2 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 5 Press G2 to select The priming amount of 25 units of insulin is shown on the display 6 When START PRIMING is displayed press and hold 2 until you hear a melody and the piston rod moves forward START PRIMING The priming process begins and a count up is 75S OI shown on the display Your pump stops priming after 25 units When the priming process is finished your pump returns to STOP te 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 STOP PRIMING You can stop the priming process at any time by E OI pressing any key
21. insulin delivered from midnight to midnight basal rate plus boluses starting with the most recent entry and working backward in time Each daily insulin total screen displays the following history e daily total of insulin delivered Z e its date fz and e entry number 01 is the most recent of total entries example 01 30 of a daily insulin total Follow the steps below 1 Press G to move to the INFORMATION screen IMFORMAT Ot Press GA to select 2 Press G to move to the DAILY TOTALS screen DAILY TOTALS Biag a 4 20 m 11 29 3 Press or to review the entries DAILY TOTALS Press GA to exit 2 H6 a 56 1U w ives Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Review the Temporary Basal Rate History The Temporary Basal Rate TBR history lets you review the last 30 TBR increases or decreases starting with the most recent entry and working backward in time Each TBR history screen displays the e TBR increase 4 or decrease in percentage e TBR duration e time e date f2 and e 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 G to move to the INFORMATION screen IMFORMAT IOH Press GA to select lil 2 Press G to move to the TBR HISTORY screen TBR HISTORY 12H BLAS Heil lt B4Pr lives E a A Hi 3 Press or scroll or to revie
22. 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 pump The cartridge is correctly inserted when the end plate of the piston rod sits flush against the cartridge plunger This flush fit is an extra safety measure to prevent the free flow of insulin and to minimize occlusions blockages Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump lf the end plate of the piston rod does not sit flush against the cartridge plunger remove the cartridge from the cartridge compartment Hold the cartridge and adapter next to the cartridge compartment Press or to move the piston rod forward until its base plate and the cartridge plunger are level The displayed cartridge volume decreases accordingly Re insert the cartridge into the cartridge compartment f needed repeat this step until the cartridge is correctly inserted the end plate of the piston rod sits flush against the cartridge plunger 10 Press after correctly inserting the cartridge Your pump performs a self test See the section System Check Start Up Process page 28 SELF TEST 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
23. make large changes to a value in most cases you can do this faster by pressing and holding down the or key scrolling until the number you want is displayed If needed the value can still be corrected by a single press of the or Your pump will beep once when you start scrolling Key Combinations Keys can be pressed in pairs for additional functions In the following table a plus symbol between 2 keys means that both keys must be pressed simultaneously Combination GD GD DW amp Function e exiting menus function screens and information screens without saving e moving backwards to a previous menu pniocking the keys press and hold both keys until you hear three beeps in RUN mode and one beep in STOP mode copying an hourly basal rate to the next hour s n If the keys on your pump are not functioning properly or you are not able to identify them correctly disconnect your WARNING insulin pump and contact Pump Support at 1 800 688 4578 Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Locking Keys Using KeyLock Feature The KeyLock feature lets you lock all four keys on your pump as a safety measure against accidentally activating functions You may want to use this function while sleeping or during sports for example The KeyLock function is turned on in the STANDARD SETUP MENU All instructions in this user guide are given on the assumption that the KeyLock i
24. may lock your basal rate profiles to provide extra protection against accidentally changing a basal rate during normal operation When this function is activated your hourly basal rates cannot be changed Follow the steps below 1 Press to move to the SETUP MENU ADVANCED screen Press to select 2 Press G to move to the BASAL RATE LOCK screen BASAL RATE LOCK Press or to turn the basal rate lock ON or OFF OFF 3 Press to save and exit Note If the basal rate lock is set to ON T 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 G to move to the PROGRAM BASAL RATE screen and press to select The symbol in the BASAL RATE TOTAL screen indicates the lock of the basal rate programming The symbol appears in the BASAL RATE TOTAL screen only Press G to view the hourly basal rates The and functions are blocked Chapter 5 User Menus k ACCU CHEK Spirit Insulin Pump Language Your pump is programmed in several languages These languages include Italian English German French Spanish Portuguese Czech Dutch Swedish Norwegian Polish and Greek To choose a language do the following 1 Press G to move to SETUP MENU ADVANCED screen Press to select 2 Press G to move to the LANGUAGE screen Press or to select a language 3 Press GA to save and exit Chapter 5 User Menus ACCU CHE
25. meets the safety requirements of national medical device legislation and meets or exceeds the international standards for Electromagnetic Compatibility regarding the pump s use This section introduces you to the intended use of the ACCU CHEK Spirit insulin pump to its safety features and to warnings and safety information you need to know while using your pump While your pump is in use two internal safety systems monitor and 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 insulin pump is intended for the subcutaneous continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician The ACCU CHEK Spirit insulin pump is intended for the use of U100 rapid acting insulin ae Guarantee Any changes 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 Contents Chapter 1 Understanding Your New Sy
26. minutes E Hc IGFM A a ee Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 4 Press to move to the SET YEAR screen SET YEAR Press or to set the year le BASIBP 1 e 14 5 Press amp D to move to the SET MONTH screen SET MOHTH Press or to set the month i aJ AFPM 1iraisag 6 Press amp D to move to the SET DAY screen SET DAY Press or to set the day tz BSAP 11 25 H4 7 Press GA to save and exit Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Your Personal Settings Ad WARNING Your new ACCU CHEK Spirit insulin pump must be programmed with your personal settings prior to starting insulin pump therapy Work with your doctor or healthcare team to understand how to use the pump Always check your personal settings before using your new pump in order to avoid incorrect insulin delivery Record your personal settings from your current insulin pump and ensure that they are correctly programmed into a new ACCU CHEK Spirit insulin pump Incorrect programming of your insulin pump may cause incorrect insulin delivery Do not operate your insulin pump without knowing your personal settings f 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 Mak
27. mode it does not deliver any insulin The insulin delivery is only stopped if an error occurs or if your pump is put into STOP mode for example when changing the cartridge adapter or infusion set or for data transfer Functions such as Extended Bolus or Temporary Basal Rate are interrupted by putting your 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 Timeout For your safety and convenience your pump returns to the RUN or STOP screen if no key is pressed within a certain time Any changes made are not saved U100 Each milliliter of liquid contains 100 International Units of insulin Your pump was developed only to use U100 rapid acting insulin analogs Appendixes ACCU CHEK Spirit Insulin Pump ACCU CHEK Spirit INSULIN PUMP SYSTEM LIMITED FOUR YEAR WARRANTY DISETRONIC MEDICAL SYSTEMS INC DISETRONIC WARRANTS THE ACCU CHEK SPIRIT INSULIN PUMP INSULIN PUMP AGAINST DEFECTS IN MATERIALS AND WORKMANSHIP FOR A PERIOD OF FOUR 4 YEARS FROM THE DATE OF PURCHASE PROOF OF PURCHASE DATE MAY BE REQUIRED THIS WARRANTY DOES NOT INCLUDE SUPPLIES AND ACCESSORIES INCLUDING BUT NOT LIMITED TO CARTRIDGES BATTERIES OR
28. programming you may program the Quick STANDARD Bolus using one finger After the bolus is programmed you can count the beeps and vibrations of your pump to verify the correct programming The bolus increment for the Quick Standard Bolus is initially set to 0 5 units Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump BNC 3 sec ADC bolus delivery confirmation Of amount 5 sec delay A8 bolus cancelled Follow the steps below 1 From the RUN screen press and hold gt until you hear a beep sequence and feel a vibration STANDARD EOLUS This activates the Quick STANDARD 0 00 BOLUS function Hint start programming with the key in areas of poor lighting as this will also turn on the backlight 2 Press repeatedly until the bolus amount is reached STANDARD BOLUS Each press of the gt key adds one bolus SU increment to the bolus amount Your pump beeps and vibrates simultaneously once for each programmed bolus increment Five seconds after the last press of your pump confirms the total bolus amount with one beep and vibration for each bolus increment programmed The Standard Bolus symbol _L 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
29. pump returns itself to the RUN or STOP screen if no key is pressed within 20 seconds For your safety the changes you made before your insulin pump times out will not be saved Chapter 5 User Menus 99 ACCU CHEK Spirit Insulin Pump selecting a User Menu select the user menu RUN a gt screen Ce CI select basal rate profile DO 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 Follow the steps below 1 Press G to move to the SELECT USER MENU screen Press amp to select Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump 2 The current user menu is selected on the SELECT USER MENU screen SELECT USER MENU Press or to select a different user menu gt SADUANCED CUSTOM 3 Press to confirm PROF ILE The selected basal rate profile and its daily insulin 12 BU total appear or PROFILE if the previous basal rate profile is not available ify from the selected user menu dashes appear instead 4 Press or to select a basal rate profile if needed Check the new basal rate profile and its daily insulin total 5 Press to save and exit The new user menu and basal rate profile are active immediately Chapter 5 User Menus ACCU CHEK Spirit
30. 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 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 change system components if needed Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Connecting the Cartridge Adapter and Infusion Set Note Before you change the cartridge adapter and infusion set check that your pump is in good working order See the section System Inspection Checklist page 137 Insulin can flow freely from the cartridge or infusion set if the cartridge plunger and the piston rod are not properly connected and the pump is positioned at a higher level than the infusion site Prevent free flow of insulin by correctly inserting the cartridge move the piston rod to the proper position and twist the adapter until the cartridge plunger sits flush with the end plate of the piston rod Have the following materials ready o A filled ACCU CHEK 3 15 ml plastic cartridge with a luer lock connection o An ACCU CHEK Spirit insulin pump adapter e A new ACCU CHEK infusion set A The cartridge and infusion set are sterile
31. turned on A Alarm clock turned off Single alarm when setting an alarm clock Every day repeat alarm when setting an alarm clock n PC communication Ci Set beep volume WAD Check key OO Up key wD Down key Timeout of a menu Appendixes ACCU CHEK Spirit Insulin Pump Appendix G Sterile Products and Accessories Sterile Products Cartridges Name Comments Empty ACCU CHEK Plastic cartridges are single use 3 15ml Plastic Cartridge items Do not reuse cartridges Refer to the instructions of the insulin you are using for information of proper use and acceptable temperature range for storage 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 is a great option for new pumpers or those with vision or dexterity issues Appendixes ACCU CHEK Spirit Insulin Pump Accessories Name Adapter Battery One 1 5 AA alkaline battery with a minimum capacity of 2500mAh Rechargeable Battery One AA NiMH rechargeable battery with a minimum capacity of 1500 mAh Battery Cover Carrying Systems Comments Replace your adapter with every 10 cartridge If used in a typic
32. 0 for decreases 110 200 for increases The duration is adjustable in 15 minute intervals up to a maximum of 24 hours The last programmed duration is given by default for the next temporary basal rate change programmed Weight e Empty approx 2 8 oz 80 g e Pump w battery full plastic cartridge and infusion set approx 4 oz 110 g Appendixes ACCU CHEK Spirit Insulin Pump Technical Standards on Electromagnetic Emissions The standard concerning electromagnetic compatibility of medical equipment IEC 60601 1 2 requires the concrete specification of the corresponding levels which refer to specified electromagnetic interferences The following is Guidance and manufacturer s declaration on electromagnetic emissions Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 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 supply network that supplies buildings used for domestic purposes Harmonic Not applicable emissions IEC 61000 3 2 Voltage Not applicable fluctuations flicker emissions IEC 61000 3 3 Appendixes ACCU CHEK Spirit Ins
33. 00 TBR increase or decrease in increments of 10 10 TBR duration max 24 h 15 min 24h 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 duration Extended max 24 h 15 min 24 h bolus MultiWave bolus bolus duration increments 15 min 15 min 30 min 1h Appendixes ACCU CHEK Spirit Insulin Pump Typical Range and Maximum Parameter Parameter Settings Range Prime volume U100 25 0U Insulin Type Max Amount U100 Q 25 01U h Display orientation standard standard or inverted Display contrast medium 13 steps User menus STANDARD 3 STANDARD ADVANCED or CUSTOM Volume for beeps maximum off 1 4 steps beeps vibrations or both Alarm signals turned on beeps and vibrations AA Alkaline or AA NiMH rechargeable battery turned on or off turned on or off Automatic off off Battery type AA battery KeyLock off Alarm clock off Time format Date format 0 1 24h turned on or off when on once or every day s occurrence American 12 h am pm or European 24 h American mm dd yy or European dd mm yy Appendixes ACCU CHEK Spirit Insulin Pump Appendix C Abbreviations approx BR BRP
34. 2 130 Time and Date Review 150 Time Remaining 112 Troubleshooting 143 146 Tubing 20 132 UP Key 9 187 User Menu 99 102 Advanced 122 Custom 136 Standard 103 Water 63 Contact with 63 After Contact with 64 Oo aa ai Diagram of User Menus Quick Reference Table for Alerts In all cases turn off and confirm the alert prior to addressing the issue Your Insulin pump STANDARD MENU No Alert What You Need to Do EEND Al CARTRIDGE LOW Change cartridge before it is completely nes oe empty ee ____ re A2 BATTERY LOW Replace the battery as soon as possible tandard m ee a amoun ccu Gne cartridge priming 0 Istory rate tota A4 ALARM CLOCK Put your ACCU CHEK Spirit in RUN mode dbs 10 0U h pn T A Quick with direct access from the RUN screen y p Standard bolus usingthea and keys of your if Necessaly daily insulin tth larm i li S sisunts m a A5 PUMP TIMER Your pump s operating time will expire Gli i utomati B Scroll menu guided using the STANDARD BOLUS Sine e T Standard bolus menu and the scroll function of thea and soon Go to the INFORMATION screen on SI keys for programming the bolus amount your pump then move to the PUMP TIMER a e I H i For a complete review of your insulin pump features as well as Screen The days until the pump timer gee the warnings and precautions associated with its use please expires is shown Make arrangements for refer to your ACC
35. 3 Guarantee 4 History 107 Alarm 109 Bolus 107 108 Daily Insulin 110 Temporary Basal Rate 111 an Immunity 171 172 Infusion Set 9 19 20 Changing the 70 72 Not Primed 162 163 Priming 53 55 Infusion Site 56 57 72 Insulin Delivery Starting 65 Stopping 66 Insulin Pump Therapy Interruption of 68 69 Resuming 69 KeyLock 13 Turning On 113 114 Turning Off 113 114 Unlocking 181 185 Keys 11 Key Combinations 12 Language 134 Language Error 164 Liquids 64 Luer Lock 192 Maintenance 141 Mechanical Error 159 160 Menus 99 102 Advanced 122 Custom 136 Standard 103 MultiWave 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 Pump 9 Stopping 66 Storing 140 Wearing 59 60 Quick Info Screen 14 Quick Information 30 Repair 142 RUN Screen 13 192 Safety System 147 168 Screen 9 10 scrolling 193 Setup Menu Advanced 129 186 Standard 113 186 Standard User Menu 99 103 Start Up 28 31 Status Screen 15 Sterile 17 188 Stop Warning 16 67 al Quick Reference Table for E
36. 3 59 example 13 39 Follow the steps below 1 Press G to move to the SETUP MENU ADVANCED screen SETUP MEHU Press to select ADWAMCED a TL 2 The TIME FORMAT screen appears TIME FORMAT Press or to select a time format T Ki ASISSPM Boa Re aS 3 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Date Format You can set the date in the following formats American mm dd yyyy example 04 26 06 European dd mm yyyy example 26 04 06 Follow the steps below 1 Press G to move to the SETUP MENU ADVANCED screen SETUF MEHI aDLIANCED Press GA to select lt a es 2 Press amp D to move to the DATE FORMAT screen URMAT Press or to select a date format 3 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Bolus increment j The bolus increment that can be programmed into your insulin pump determines the Quick Standard Bolus WARNING amount using the and keys of your insulin pump Incorrect programming of the bolus increment may cause inappropriate insulin delivery To address patients who may need large or small amounts of insulin the bolus increment for the ACCU CHEK Spirit insulin pump is adjustable The Quick Standard Bolus is initially set to 0 5 units per key press but can be changed in the SETUP MENU ADVANCED to 0 1 0 2 0 5 1 0 or 2 0 units Units for the scroll Standard
37. 6 Chapter 6 Care and Maintenance 4 137 Care of Your ACCU CHEK Spirit Insulin Pump 137 System Inspection Checklist 137 What to Do When You Drop Your Pump 139 Storing Your ACCU CHEK Spirit Insulin Pump 140 Disposal 140 Maintenance 141 Repair 142 Troubleshooting 143 ae Chapter 7 Alerts and Errors a 147 Confirming an Alert or Error 148 List of Alerts 149 List of Errors 154 Appendixes a 165 Appendix A Technical Data 165 Appendix B Configuration Parameters 177 Appendix 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 194 index OO L Diagram of User Menus Quick Reference Table for Alerts Quick Reference Table for Errors Ul This page left blank intentionally CCU CHEK Spirit Insulin Pump Chapter 1 Understanding Your New System The ACCU CHEK Spirit Insulin Pump Display Menu key Up key Down key Check key Infusion set Adapter Cartridge A Check your insulin pump and its sterile products like an infusion set and accessories at least every three hours CAUTION 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 malfunction Display Your insul
38. AA battery Use AA alkaline batteries that have a minimum capacity of 2500 mAh Do not use lithium carbon zinc or nickel cadmium NiCd batteries If you prefer to use rechargeable batteries use NiMH batteries that have a minimum capacity of 1500 mAh If you use rechargeable batteries always use a battery charger recommended by the battery manufacturer Keep extra batteries on hand i j Using batteries other than those recommended by Disetronic Medical Systems may significantly reduce battery usage CAUTION time Batteries other than those recommended could leak and corrode the battery contacts within your insulin pump Therefore using batteries not supplied or recommended by Disetronic Medical Systems Inc may void the warranty The operating temperature of the battery must be between 41 F and 104 F 5 C and 40 C The life of any battery is 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 Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Note You must set the battery type to match the kind of battery you are using If you do not set the correct battery type on your pump the alert A2 BATTERY LOW may not give you enough time to repl
39. ACCU CHEK Spirit INSULIN PUMP SYSTEM ACCU CHEK Spirit a Dear ACCU CHEK Spirit insulin pump owner Thank you for choosing the ACCU CHEK Spirit insulin pump This guide will help you to get the most from your ACCU CHEK Spirit insulin pump Even if you have used an insulin pump before it s important that you do these things before you use the ACCU CHEK Spirit insulin pump gt read this guide carefully gt work with your doctor or healthcare team to understand how to use the pump gt test your blood glucose level often to find your personal settings and to avoid getting the wrong dosage of insulin An ACCU CHEK blood glucose meter is one way to test blood glucose levels talk to your doctor or healthcare team to decide the best way for you Its 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 your doctor or healthcare team If you have questions about your pump or problems with it refer to this guide and talk to your doctor or healthcare team We also invite you to contact Pump Support at 1 800 688 4578 Note Your insulin pump is a valuable medical device Consider adding your pump to your homeowner s insurance policy to protect you in case
40. ACCU CHEK Spirit Insulin Pump 4 Move to the PUMP TIMER screen PUMP TIMER The days until the pump timer expires are shown 126 DAYS When the PUMP TIMER reaches zero the pump will change to STOP mode and no longer operate An error E5 END OF OPERATION will appear on the display Contact Pump Support at 1 800 688 4578 to discuss your options for further use of your ACCU CHEK Spirit insulin pump Note The alert A5 PUMP TIMER ALERT and the error E5 END OF OPERATION are based on running time the total time the pump is in RUN mode and not calendar years However the warranty is based on the date the pump was purchased see the section Review the Time Remaining page 112 for more information Alert A6 TBR CANCELLED Temporary Basal Rate Cancelled A temporary increase or decrease of the basal rate has been cancelled 1 Press G amp A twice to turn off and to confirm the alert TBR CAMHCELLED A Ag e PLEASE COHFIRH 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 Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Alert A7 TBR OVER Temporary Basal Rate Over A Temporary Basal Rate has ended The original basal rate 100 will resume automatically once the alert has been confirmed 1 Press G amp A twice to turn off and confirm the alert TER OJER i PLEASE I OHF IRM 2 De
41. An electronic error was discovered during a routine automatic system check and the insulin delivery has stopped You cannot turn off and confirm an error E7 ELECTRONIC ERROR by pressing S You must remove the battery instead 1 Remove or disconnect the infusion set from your infusion site ELECTRONIC ERROR 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 occurs again contact Pump Support at 1 800 688 4578 for assistance Contact your doctor or healthcare team if you need an alternate therapy plan Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Error E8 POWER INTERRUPT A power interrupt error occurs when you insert a new battery without first placing the pump in STOP mode See the section Inserting or Changing the Battery page 25 for instructions on how to change your battery The error can also occur if the pump was dropped If the pump was dropped see the section What to Do When You Drop Your Pump page 139 for more information 1 Press G amp A twice to turn off and to confirm the error POWER THTERRUPT A EG e CHECK SETTINGS 2 Your pump goes in STOP mode 3 Check the time and date and correct them if they are wrong See the s
42. DDM h IEC incl IR I U IU kPa LCD LED NiMH rel sec TBR U U h U100 mm dd yy dd mm yy Approximately Basal rate Basal rate profile Diabetes Data Management Hour s International Electrotechnical Commission Inclusive Infrared International Units in context with biological effectiveness of a certain insulin amount Kilo pascals Liquid Crystal Display Light Emitting Diode for infrared communication with for example a personal computer PC Nickel Metal Hydride used with rechargeable batteries Relative second s Temporary Basal Rate see I U Amount of International Units of insulin delivered per hour Each milliliter of liquid contains 100 International Units of insulin American date format month day year European date format day month year Appendixes ACCU CHEK Spirit Insulin Pump Appendix D Beeps and Melodies You can turn off either the pump beeps or the vibrations but not both simultaneously Please refer to sections Adjust the Beep Volume page 116 and Setting Up Alarm Signals page 117 for more information Each press of CAD Each press of Ww Each press of Cl gt confirms each programmed bolus increment when programming a Quick Standard Bolus RG Each press of GV confirms the STOP Warning ee 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
43. Insulin Pump A running increased or decreased Temporary Basal Rate will remain active even if you changed the basal CAUTION rate profile The temporary basal rate is based on the new basal rate Note At any function screen you have three options to exit o f you want to confirm and save the changes press GA until your pump returns to the RUN screen e f you want to undo the changes press G simultaneously to exit the function screen or e Wait for your pump to return to the RUN screen timeout Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump STANDARD User Menu The following is a list of menu choices for the STANDARD user menu as they are addressed in the manual To view the order in which they appear on the pump refer to the menu diagrams at the back of the manual Some of the functions have already been described earlier in the manual The remaining functions are described following this list SET TIME AND DATE See the section Setting Time and Date page 32 PROGRAM BASAL RATE PROFILE See the section Programming your Basal 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
44. K Spirit Insulin Pump Display Contrast Your pump lets you adjust the display contrast Follow the steps below 1 Press G to move to the SETUP MENU ADVANCED screen Press to select 2 Press GD to move to the DISPLAY CONTRAST screen DISPLAY CONTRAST Press or to select a contrast level m 3 Press to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump CUSTOM User Menu The CUSTOM user menu contains the 11 most commonly used functions according to a customer survey The following is a list of the functions included in the CUSTOM 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 Chapter 6 Care and Maintenance Care of Your ACCU CHEK Spirit Insulin Pump A Do not perform any servicing or repair on your insulin pump For servicing or repairs contact Pump Support at CAUTION 1 800 688 4578 Disetronic Medical Systems as the manufacturer guarantees the functions of your pump according to its specifications only if all servicing of your pump is done and or authorized by Disetronic Medical Systems
45. P screen if no key is pressed within 20 seconds The changes you made before your insulin pump times out will not be saved Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Follow the steps below 1 Press G to move to the PROGRAM BASAL RATE PROFILE 1 screen PROGRAM BASAL RATE PROFILE 2 Press G amp A to select BASAL RATE TOTAL The daily BASAL RATE TOTAL is displayed amp 14 00 3 Press amp D to move to the first hour Gaa ee 61 AG The first hour which always begins at midnight di 0 5 Uh 00 00 01 00 12 00 AM 01 00 AM if the American time format is used is shown 4 Press or or scroll to set the hourly basal rate given by your doctor or healthcare team OHH Bi H dh O 6 Uh 5 Press amp D to move to the next hour MBL be Hz AH dh OS Uh 6 Continue using amp and the and 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 Getting Started ACCU CHEK Spirit Insulin Pump 7 Press to confirm BASAL RATE TOTAL The new daily BASAL RATE TOTAL is displayed amp 16 00 Check the new daily BASAL RATE TOTAL 8 Press GA to save and exit lf the current active basal rate profile is the same as the new programmed basal rate it is active immediately Note At any screen you have three option
46. PURPOSE IN NO EVENT SHALL DISETRONIC OR ITS SUPPLIERS OR DISTRIBUTORS BE LIABLE FOR ANY INCIDENTAL CONSEQUENTIAL INDIRECT SPECIAL OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE INSULIN PUMP Appendixes ACCU CHEK Spirit Insulin Pump Index Accessories 17 23 189 Adapter 9 20 47 48 190 Advanced User Menu 99 122 128 Air Bubbles 45 53 145 Alarm Clock 127 128 151 Alarm History 109 Alarm Signals 16 117 Alcohol Consumption 144 Alerts and Errors 147 164 199 200 Automatic Off 118 156 Backlight 10 Basal Rate Profile 36 123 126 190 Lock 133 Programming 37 41 124 Selecting 125 Temporary 93 96 Battery 21 141 Cover 22 Depleted 155 Inserting or changing 25 27 Key 23 71 Life 165 189 Low 150 185 Type 119 167 Beeps 15 116 181 186 187 Bolus 75 Extended 83 87 History 107 108 MultiWave 88 92 Quick Standard 77 80 Scroll Standard 80 82 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 120 187 Disposal 140 DOWN Key 9 187 Electromagnetic 61 169 172 Electronic Error 160 Emergency Kit 23 Errors 147 148 154 164 Exit Options 102 Filling Aid 4
47. Standards on Electromagnetic Immunity Guidance and manufacturer s declaration electromagnetic immunity The ACCU CHEK Spirit insulin pump is intended for use in the electromagnetic environment specified below The customer or the user of the ACCU CHEK Spirit insulin pump should assure that it is used in such an environment IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment Guidance Electrostatic 6 kV contact 8kV 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 field characteristic of a typical IEC 61000 4 8 IEC 60601 2 24 location in a typical commercial or hospital environment Conducted RF 3Vrms Not applicable IEC 61000 4 8 150 kHz to 80 MHz Appendixes ACCU CHEK Spirit Insulin Pump IEC 60601 Compliance Electromagnetic Immunity Test Test Level Level Environment Guidance Radiated RF 3 V m 10 V m Portable and mobile RF communications equipment IEC 61000 4 3 80 MHzto 80 MHz should be used no closer to 2 5 GHZ 2 5 GHZ any part of the ACCU CHEK Spirit insulin pump includ IEC 60601 2 24 ing cables than the recom mended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended s
48. TANDARD and ADVANCED user menus The SETUP MENU Standard allows you to set up certain features and settings The following features and settings can be changed using the SETUP 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 RUN STOP Ps screen TO Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Follow the steps below 1 Press amp to move to the SETUP MENU STANDARD screen SETUP MEHL Press to select STAHDARD __ 2 The current KeyLock status ON or OFF appears OFF L 3 Press or to turn the KeyLock ON or OFF KEYLOCK Press to save and exit or a 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 Chapter 5 User Menus _ ACCU CHEK Spirit Insulin Pump Unlocking the KeyLock RUN screen locked RUN screen unlocked Follow the steps below 3 sec G 1 From the RUN or the STOP screen press D simultaneously you hear three beeps in RUN mode one beep in STOP mode and hold for 3 seconds until you again hear three beeps in RUN mode
49. U CHEK Spirit Insulin Pump Check the display of your insulin pump at least every three hours during the day and before you go to sleep especially WARNING if for any reason you are unable to hear the beeps or feel the vibrations This is the only way you will be notified of changes in your insulin pump in a suitable amount of time Alarm Signals Your pump gives alerts and errors using beeps and vibrations You can turn off either the beep or the vibrations but for your safety you cannot turn off both at the same time for the initial alarm signal See the sections Alerts and Errors page 147 Adjusting the Beep Volume page 116 and Setting Up Alarm Signals page 117 for more information STOP Warning The STOP Warning is turned on by the pump each time your pump switches from RUN mode 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 or 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 programmed beep volume Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Accessories and Disposables Sterile products and accessories are a crucial part of the ACCU CHEK Spirit insulin pump sy
50. U CHEK Spirit Insulin Pump User Guide replacement of the pump before the timer reaches zero days AG TBR CANCELLED Put your ACCU CHEK Spirit insulin pump in T bam CENAN RUN mode if necessary Ensure the can cellation was intended and program a new ee monena 2 3 s N eer menu Temporary Basal Rate if necessary HERH Your Insulin pump ADVANCED MENU T em AA Cor UE A7 TBR OVER Decide whether a further Temporary Basal aa BR profile Rate change is appropriate and program gt i i bolus immediate 010 5 returning the stop alarm duration bolus dss 10 0 uh piston rod priming history bolus daily insulin duration totals start up TBR history procedure set the alarm bolus A8 BOLUS CANCELLED Put your ACCU CHEK Spirit insulin pump in e RUN mode if necessary Ensure that the sat the battery pasal cancellation was intended and program a new bolus if necessary contrast one if necessary Quick Reference Table for Alerts ACCU CHEK Spirit Insulin Pump ACCU CHEK Spirit Insulin Pump Rx only C Enz 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 ACCU CHEK Spirit INSULIN PUMP SYSTEM ACCU CHEK and ACCU CHEK SPIRIT are trademarks o
51. USTOM user menus The Extended Bolus function lets you program a bolus to be delivered over a period of time This function is helpful during long meals dinners or receptions or when you have meals that are digested slowly The Extended Bolus may also be appropriate for people who have gastroparesis delayed digestion The duration of bolus delivery can be programmed in 15 minute intervals up to 24 hours and begins immediately after confirmation 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 Extended Bolus or a MultiWave Bolus is blocked If you want to program a different Extended Bolus put the pump in STOP mode to cancel the current bolus and to program a new one D Be RUN CD Extended WM bolus bolus screen bolus amount duration stop your ACCU CHEK y A8 bolus cancelled Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Follow the steps below 1 Press G to move to the EXTENDED BOLUS screen EXTEHDED BOLUS LI 2 Press to select The BOLUS AMOUNT screen appears BOLUS AMOUNT oOo 0 0 3 Press to increase or decrease the bolus amount BOLUS AMCUNT The duration of the last Extended Bolus a aoa E U delivered appears or when using your pump for the first time a default value appears 4 Press amp D t
52. Unlock the KeyLock in STOP mode enter STOP screen Lock the KeyLock in STOP mode Exit a screen A fis ALI Cancel a running bolus or stop priming Start up procedure successful ef fee ILS Copy an hourly basal rate a i Alert and error i t t Maximum amount reached b Minimum amount reached Appendixes ACCU CHEK Spirit Insulin Pump Appendix E Vibrations Your pump signals alerts and errors using beeps and vibrations You can turn off either the beeps or the vibrations but you cannot turn off both simultaneously When you program a Quick Standard Bolus your ACCU CHEK Spirit insulin pump confirms all programming by vibrating You cannot turn off these vibrations Your ACCU CHEK Spirit insulin pump vibrates when 1 Short vibration Your ACCU CHEK Spirit insulin pump performs a Start up procedure t Medium vibration Your ACCU CHEK Spirit insulin pump confirms the programmed bolus amount of the Quick Standard bolus fail 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 Programming a Standard Bolus page 77 and Setting Up Alarm Signals page 117 for more information Appendixes ACCU CHEK Spirit Insulin Pump Appendix F Symbols General Symbols A BA Read user guide STERILE EO Sterilized using ethylene oxide STERILEIR Sterilized using ra
53. VANCED user menu or turn on the MULTIWAVE BOLUS menu choice in the CUSTOM user menu Also your pump must be in RUN mode 2 Press G to move to the MULTIWAVE BOLUS screen MULTIWAWE BOLUS h 3 Press to select BOLUS AMOUNT The BOLUS AMOUNT screen appears 0 00 4 Press or to increase or decrease the total bolus amount BOLUS AMOUNT The first time you press C amp S 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 Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump a4raA E a7 5 Press G to move to the IMMEDIATE BOLUS screen IMMEDIATE BOLUS Press or to correct and set the immediate E an Ok Ue bolus amount 6 Press G to move to the BOLUS DURATION screen BOLUS reli Press or to correct and set the Extended eer Me on Bolus duration in increments of 15 minutes for up to 24 hours Note Press to loop between programming the total bolus amount immediate bolus amount and Extended Bolus duration 7 Check the total and immediate bolus amounts and the extended bolus duration programmed on the display The set values can be viewed in the BOLUS AMOUNT IMMEDIATE BOLUS and BOLUS DURATION screens 8 Press to confirm both
54. Your pump displays the STOP PRIMING screen Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Preparing the Infusion Site and Inserting the Infusion Set Always follow the instructions given to you by your doctor or healthcare team and the instructions for the infusion set you are using Change your infusion set as frequently as recommended by the manufacturer Infusion Site Selection Your doctor or healthcare team will help you select your infusion site areas according to a planned rotation pattern Avoid your waistline bones scar tissue recent infusion sites bruises and sores Choose an infusion site at least one inch 2 5 cm away from the navel and previous infusion sites Infusion Site Preparation It is important to prepare the infusion site properly to reduce the risks of infection Your doctor or healthcare team will give you infusion site preparation guidelines Have the following materials ready o Your ACCU CHEK Spirit insulin pump o A disinfectant for your skin e A new ACCU CHEK infusion set Follow the steps below 1 Make sure your pump is correctly set up including cartridge adapter and infusion set and is programmed with your personal settings Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 2 Wash your hands thoroughly 4 Make sure your pump is in STOP mode M142Ph E a56 gmi 5 Insert your ACCU CHEK infusion set according to the instructions for its use Ch
55. ace your battery If you change from using regular batteries to rechargeable batteries or from rechargeable batteries to regular batteries you must change the battery type setting in the Standard setup menu SETUP MENU STANDARD A Always make sure that you remove the battery if your insulin pump is not in use for a long time period in order CAUTION 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 Battery Cover The battery cover seals the battery compartment Change the battery cover with at least every 4 battery change e Remove the battery cover only in a dry area to prevent water from getting inside the pump e Make sure that the seal is not worn or missing and that the battery is properly inserted into the pump e Tighten or loosen the battery cover using only the ACCU CHEK Spirit insulin pump battery key Knives screwdrivers or other sharp objects may harm your pump e Do not over tighten the battery cover The battery cover is correctly inserted and tightened when it is even with the pump casing Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Battery Key The battery key tightens and loosens the battery cover It can also loosen the luer lock connection between the infusion set and adapter if it cannot be loo
56. adjustable in intervals of 15 minutes 15 minutes up to 24 hours Cartridge ACCU CHEK 3 15 ml plastic cartridge with 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 voltage and time the insulin pump has been without a battery Data transfer Infrared interface Delivery 1 20th of the current hourly basal rate in 3 minute intervals Dimensions maximum Approx 3 2 x 2 2 x 0 8 inches without adapter 81 x 55 x 20 mm Appendixes ACCU CHEK Spirit Insulin Pump Flow delivery rate Infusion sets IPX 8 Maximum time for an error E4 OCCLUSION Maximum volume before error Maximum pressure Maximum quantity delivered at a single fault condition Power supply Pump casing 0 2 U sec during infusion set priming and bolus when using U100 insulin ACCU CHEK infusion sets with luer lock connector Protected against the effects of temporary immersion in water under standardized conditions up to 60 minutes and 8 feet 2 5 meters Plastic cartridges e at med basal rate 1 0 U h using U100 insulin lt 5h e at min basal rate 0 1 U h using U100 insul
57. al Rate is immediately activated Note At any function screen you have three options to exit if you want to save the changes e Press GD Your pump returns to the RUN screen if you want to undo the changes e Wait for your pump to return to the RUN screen timeout or e Press G D simultaneously exit feature to exit the function screen e Set volume to 100 and press a Chapter 4 Boluses and TBRs J ACCU CHEK Spirit Insulin Pump 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 pointing down symbolizes a Temporary Basal Rate decrease Note lf an Extended Bolus or a MultiWave Bolus is active at the same time the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen TBR OVER Alert At the end of a Temporary Basal Rate an alert A7 TBR OVER occurs Press D twice to confirm and turn off the alert See the section Alert A7 TBR OVER page 153 for more information Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Cancelling a Temporary Basal Rate during programming There are three ways to cancel a Temporary Basal Rate during programming e Do not press any key for 20 s
58. al 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 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 one week for rechargeable batteries Replace your battery cover with every 4 battery Disetronic Medical Systems offers a wide range of carrying system solutions to best fit your lifestyle Appendixes ACCU CHEK Spirit Insulin Pump Appendix H Glossary Adapter The adapter connects the cartridge and infusion set It has two seals for the cartridge compartment of your insulin pump The two small vents on the adapter let air pressure equalize Basal rate The amount of insulin needed to cover your own basic insulin needs In insulin pump therapy your basal rate is determined by your doctor or healthcare team and can be adjusted to meet your body s specific needs throughout the day Your basal rate is delivered by your insulin pump according to your personal basal rate profile or profiles Basal rate profile Your pump can be set to deliver up to five different basal rate profiles to match changing insulin needs for example during the week 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 to
59. apter 2 Getting Started ACCU CHEK Spirit Insulin Pump Note lf 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 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 CAUTION are not limited to pain lumps redness heat or discharge If you see redness or swelling change your infusion headset and infusion site immediately and contact your doctor or healthcare team Change your infusion headset according to the instructions for the infusion set you are using and your doctor or healthcare team s recommendations If you have read and followed all instructions cautions warnings and notes found in this chapter your pump should now be ready to use However please read the complete manual before starting Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Chapter 3 Using Your Pump Before Using A Training and using your insulin pump requires the support of an experienced doctor or healthcare team Regular visits CAUTION to your doctor or healthcare team are absolutely essential during insulin pump therapy Always follow the instructions given by
60. at the same time turn the insulin vial over 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 and let the insulin flow into the cartridge Do 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 cartridge 7 Remove the filling needle from the insulin vial 8 Place the protective cap on the filling needle Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Remove the plunger rod by turning it counter clockwise out of the plunger ia Remove the filling needle with its protective cap from the cartridge by turning counter clockwise Dispose of properly 2 lt 6 Push the cartridge protective cap tightly onto the cartridge tip until it clicks The cartridge is now ready to use Note Do not pull or push the plunger rod during removal Air bubbles in the cartridge and infusion set may cause the infusion of air instead of insulin In this case your body CAUTION does not receive the
61. battery low and special functions such as KeyLock locked or unlocked Some functions must be programmed while your pump is in STOP mode when insulin is not being delivered Your pump must also be in STOP mode before you can change cartridges Additionally always disconnect your pump from the infusion site and place 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 Accu Chek Seirit If you press the SA key from the RUN or STOP m 4 U o screen your pump displays the remaining cartridge content in units Symbols for activated functions and features like the beep and vibration alarm signals are displayed Your pump will return to the RUN or STOP screen after 8 seconds Information Function and Setup Screens You will need to access various screens so you can view stored information program the pump perform a function or change a setting You can reach these screens from either the RUN or STOP screen Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Follow the steps below to navigate through the screens 1 Press the G gt key to move to a screen displaying your first choice Think of these screens as menu choices 2 Press the amp D key again to see your next choice on the menu After you reach the last menu choice you will loop back t
62. bolus amounts and the bolus duration The MultiWave Bolus symbol E 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 MBS SSSPh i4 Hi 1 1 BE h Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Note Once the immediate bolus is delivered the remaining time bolus amount and the current hourly basal rate are displayed on the RUN screen lf a Temporary Basal Rate is active at the same time the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed on the RUN screen Cancelling a MultiWave Bolus during programming a bolus amount or the bolus duration blinks There are three ways to cancel a MultiWave Bolus during programming e Do not press any key for 20 seconds The pump returns to the RUN screen timeout e Exit to the MULTIWAVE BOLUS screen by pressing gt gt simultaneously e Set the total bolus amount to 0 0 units and press No bolus is delivered during the start delay blinks e Press V or The pump beeps and vibrates The pump returns to the RUN screen An alert A8 BOLUS CANCELLED occurs Press GA twice to confirm and turn off the alert No bolus is delivered See the section Alert A8 BOLUS CANCELLED page 153 for more information during bolus delive
63. cide whether a further Temporary Basal Rate change is needed If necessary program a new Temporary Basal Rate Alert A8 BOLUS CANCELLED A bolus was cancelled during the start delay or after delivery began 1 Press G amp A twice to turn off and to confirm the alert BOLUS CANCELLED A AB e PLEASE COWFIRM 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 section Review the Bolus History page 107 for more information Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump List of Errors After the occurrence of an error your insulin pump will be in STOP mode and the insulin delivery is interrupted In order WARNING to maintain insulin delivery you must act immediately according to the instructions given for each error code Error E1 CARTRIDGE EMPTY The insulin cartridge is empty Change the cartridge immediately 1 Press twice to turn off and to confirm the error CARTREICGE EMP T i A ET amp CHANGE CARTRIDGE 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 at your infusion site 5 Put your pump in RUN mode See the section Changing the Cartridge and Infusion Set page 73
64. ctions provided with your infusion set 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 Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump 1 Press G amp A twice to turn off and to confirm the error SET HOT PRIMED AN T START FEIMIHG 2 Remove or disconnect the infusion set from your infusion site 3 Prime the infusion set 4 Reconnect the infusion set tubing at your infusion site 5 Put your pump in RUN mode See the sections Changing the Cartridge and Infusion Set page 73 and Priming the Infusion Set page 53 for more information Error E12 DATA INTERRUPTED If data transfer between compatible software and your insulin pump is disrupted in any way the configuration CAUTION may be incomplete and an error E12 DATA INTERRUPTED occurs The data transfer must be completed successfully before you can put your insulin pump into RUN mode Data transfer between your pump and a PC was interrupted before it was completed 1 Press G amp A twice to turn off and to confirm the error DATA THTERRUPTED A E12 amp RESTART TRANSFER 2 Restart the data transfer Before you can put your pump in RUN mode the data transfer must be successful Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump See the section Data Transfer page 104 for more information Error E13 LANGUAGE ERROR The la
65. ded Bolus during programming o f you do not press any key for 20 seconds your pump returns to the RUN screen timeout e Exit to the EXTENDED BOLUS menu by pressing gt gt simultaneously e Set the bolus amount to 0 0 units and press No bolus is delivered during bolus delivery e f the Extended Bolus delivery has begun it can be cancelled by putting your pump into STOP mode This cancels the bolus delivery and an alert A8 BOLUS CANCELLED occurs Press 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 the Bolus History page 107 for more information When your insulin pump is in STOP mode it does not deliver any insulin Put the pump in RUN mode to continue the CAUTION insulin delivery Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Note lf a Temporary Basal Rate is active at the same time it is also cancelled when your pump is put into STOP mode An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press GA twice to confirm and turn off the first alert The second alert appears on the display Press GA 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 a
66. dge contains enough insulin to last through the night and e that the time and date are set correctly Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Chapter 4 Boluses and Temporary Basal Rates Understanding Boluses 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 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 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 _L Standard Bolus fast delivery C Extended Bolus delivery over a programmed period of time h MultiWave Bolus combines fast delivery with delivery over a programmed period of time Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump e Incorrect programming of your insulin pump may cause inappropriate insulin delivery WARNING Your insulin pump must be programmed with your personal settings prior to starting insulin pump therapy o Do not operate your insulin pump without knowing your personal settings e If you are not sure about your personal settings or you are less experi
67. diation STERILE Sterilized using antiseptics Es Year of manufacture _ O S Batch number Expiration date he Item number JJ mi TI Serial number Admissible temperature range during operation Admissible temperature range Admissible humidity range Admissible air pressure range Fragile handle with care aa were Protect against moisture Appendixes ACCU CHEK Spirit Insulin Pump NY JN TOE Protect from heat and sunlight For single use only Does not contain pyrogen Does not contain PVC Recycling Ki Do not throw away D Do not use if the package is damaged Flammable aG See Electronic device of type BF according to the standard IEC 60601 1 Protection against electrical shock Symbol for protection against the effect of temporary immersion amp gt IPX8 in water up to 60 minutes and 2 5 meters 8 feet according to IEC 60529 Marking of conformity according to the European Medical C Enz 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 Rx only order of a physician FCC ID Federal Communications Commission part 15 on radio frequency devices aa Manufacturer Appendixes ACCU CHEK Spirit Insulin Pump Symbol Definition Ww Start your ACCU CHEK Spirit insulin pump STOP screen and Stop insulin delivery Q Time and Set the time and date menu Date k Locked
68. dless of power loss However it may be necessary to enter the time and date again 1 Press G amp A twice to turn off and to confirm the alert REVIEW Review the time and date and correct them A Aj eh if they are wrong TIME AND DATE 2 If necessary put your pump in RUN mode See the section Setting Time and Date page 32 for more information Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Alert A4 ALARM CLOCK An alarm clock reminder was programmed into the pump 1 Press G amp A twice to turn off and to confirm the alert ALARM CLOCK A A4 e PLEASE COHFIRH 2 If necessary put your pump in RUN mode Note lf you have set the alarm occurrence to EVERY DAY the same alert occurs every 24 hours Turn the alarm clock function OFF if you do not want the alarm to go off again at that same time every day see the section Alarm Clock page 127 for more information Alert A5 PUMP TIMER Your pump s operating time will expire soon It is recommended that you replace your pump after a period 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 GA twice to turn off and to confirm the alert PUMP TIMER ALERT fry PLEASE CONFIRM 2 Put your pump in RUN mode 3 GO to the INFORMATION screen on your pump IHFURMAT ITOH Chapter 7 Alerts and Errors
69. 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 Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump precentage RUN GD screen temporary 2 basal rate Follow the steps below 1 Put your pump in RUN mode 2 Press GD to move to the TEMPORARY BASAL RATE TBR screen TEMPORAR BASAL EATE lok dh 3 Press to select TER PERCEMTAGE The TBR PERCENTAGE screen appears ih 100 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 4 Press or to increase or decrease the basal rate TBR PERCENTAGE a p 42 HA Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Note When you increase or decrease the Temporary Basal Rate the duration of your previous Temporary Basal Rate increase or decrease appears When you use your pump for the first time a default value appears 5 Press G to move to the TBR DURATION screen TER DURATION Press or to correct and set the duration gt 03 00 Note Press to loop between programming the basal rate percentage and duration 6 Press SA to save and exit MA4I5HPM AS ae Ea 5 a 1 H 6B h The new Temporary Bas
70. e sure you know your personal carbohydrate to insulin ratio and your correction bolus ratio Change your personal settings only after consulting with your doctor or healthcare team and always follow their instructions Chapter 2 Getting Started J ACCU CHEK Spirit Insulin Pump Your Basal Rate Profile Your pump delivers insulin every 3 minutes in 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 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 e after any programming changes are made to your pump e after a new battery is inserted and e after confirming an error E7 ELECTRONIC ERROR Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Programming Your Basal Rate Profile 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 RUN Can wees program GO daily basal G gt Cae UT 1 sit total Note For your safety and convenience during programming your insulin pump returns itself to the RUN or STO
71. ealthcare team Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Chapter 7 Alerts and Errors A safety system monitors and controls the function of your pump This safety system performs more than 9 million safety checks every day If it detects a change from the pump s normal state it will trigger an alert warning instruction or an error error message Beeps vibrations and messages on the pump display indicate the cause of an alert or error Alerts and errors are the only way you will be quickly notified of any changes in your pump A Check the pump display at least every three hours during the day and before you go to sleep and especially if you CAUTION might be not be able to hear the beeps or feel the vibrations Your pump gives alerts and errors using beeps and vibrations You can turn off either the beeps or the vibrations but for your safety you cannot turn off both at the same time for the initial alarm signal lf 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 level until confirmed Note The volume of the STOP Warning is separate from the programmed beep volume and cannot be changed It always occurs at the maximum level KeyLock is unlocked by the system each time an alert
72. econds The pump returns to the RUN screen timeout e Exit to the TEMPORARY BASAL RATE TBR screen by pressing G simultaneously e Set the TBR percentage to 100 Press lt 2 to save and exit No Temporary Basal Rate is delivered during delivery There are two ways to cancel a Temporary Basal Rate during delivery e Set the TBR percentage to 100 1 Press G to move to the TEMPORARY BASAL RATE TBR screen TEMPORAR BASAL RATE TBR 2 Press GA to select TBR PERCENTAGE The TBR PERCENTAGE screen appears a m 42 Ae 3 Press or to return the basal rate to 100 TER PERCENTAGE Press to save and exit dh I00 e Or put your pump in STOP mode The Temporary Basal Rate delivery is interrupted An alert A6 TBR CANCELLED occurs Press GA twice to confirm and turn off the alert Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump When your insulin pump is in STOP mode it does not deliver any insulin Put your insulin pump in RUN mode to continue CAUTION the insulin delivery Note lf an Extended Bolus or a MultiWave Bolus is active at the same time itis also cancelled when your pump is put into STOP mode An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press GA twice to confirm and turn off the first alert The second alert appears on the display Press twice to confirm and turn off the second alert Both alerts are recorded in the alarm history see the sec
73. ection 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 mode 6 Program a new bolus and or Temporary Basal Rate if you need them See Boluses and Temporary Basal Rates page 75 lf an error E8 POWER INTERRUPT occurs during programming check your settings Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Error E10 CARTRIDGE ERROR The CHANGE THE CARTRIDGE function was not correctly carried out 1 Press GA twice to turn off and to confirm the error CARTE ICGE ERROR Aa n FEIHSEET CART 2 Remove or disconnect the infusion set from your infusion site 3 Start the CHANGE THE CARTRIDGE menu 4 Prime the infusion set 5 Reconnect the infusion set tubing at your infusion site 6 Put your pump into RUN mode 7 lf an error E10 CARTRIDGE ERROR occurs during the winding of the piston rod insert a new battery into the pump and repeat steps 1 6 Error E11 SET NOT PRIMED Never prime an infusion set that is connected to your body You risk uncontrolled insulin delivery into your body With WARNING detachable infusion sets make sure you have disconnected the tubing from your site prior to priming Always follow the instru
74. enced have your doctor or healthcare team check your personal settings e Work with your doctor or healthcare team to determine the timing amount and type of bolus you need to deliver e Make sure you know your personal carbohydrate to insulin ratio and your correction bolus ratio Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Programming a Standard Bolus There are two ways to program a Standard Bolus Quick Standard Bolus Scroll Standard Bolus Using and on your Menu guided using G gt and CD insulin pump with bolus increments with and for determined by the user programming of the amount The bolus amount per delivery is limited to 25 units using U100 insulin After you program a Standard Bolus there is a delay of 5 seconds before the bolus delivery starts This delay lets you cancel the bolus before delivery starts by pressing the or key Alert A8 BOLUS CANCELLED will occur Press twice to confirm 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 gt and keys You can start with either key The recommended steps below are those described with the first key appearing without parenthesis such as For the alternative step press the key in the parenthesis such as Note Because your pump beeps and vibrates to guide you safely through the
75. eparation distance d 0 4 P 80 MHz to 800 MHz d 0 7 VP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interface may occur in the vicinity of equipment marked with the following symbol o Appendixes ACCU CHEK Spirit Insulin Pump Accuracy of Flow Rate for Plastic 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 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 i Percentage error of flow Observation interval min The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is lt 5 Appendixes ACCU CHEK Spirit Insulin Pump Start up graph over the stabilization period The start up graph shows changes in the flow rate over the stabilization time 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 tempera
76. er dust insulin or other foreign substances to enter your insulin pump and lead to malfunction If you have questions or are not sure whether your pump has been damaged contact Pump Support at 1 800 688 4578 Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump storing Your ACCU CHEK Spirit Insulin Pump When your insulin pump will not be in use for a long period of time it should be properly stored to prevent a malfunction CAUTION To store your pump place in STOP mode then e Remove the battery to preserve the battery life e Remove the cartridge e Insert the battery cover and the adapter e Store your pump in its shipping case Storage Conditions Temperature 41 F to 113 F 5 C to 45 C Air humidity 5 to 85 relative air humidity Barometric pressure 700 to 1060 mbar Disposal Your ACCU CHEK Spirit Insulin Pump If you need to dispose of your 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 disposable object or put it in a hard shell container Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Maintenance Cleaning You
77. er menu and event memory bolus and alarm history history of daily insulin totals and Temporary Basal Rates even if the battery power dies and no matter how long your pump is without power see the section Accessories and Disposables Battery page 21 for information on recommended batteries Keep the Time Date Settings Correct Always check that the time and date of your insulin pump WARNING are set correctly The time and date are displayed on the STOP screen Incorrect programming of the time and date may cause incorrect insulin delivery If you your doctor or healthcare team store and analyze your therapy data electronically and the time and date of the devices used are not set identically the gathered data might not be meaningful See the section Setting Time and Date page 32 for more information A CAUTION To prevent water from entering the casing change the battery only in a dry environment Make sure that the battery seal is not worn out or missing and that the battery 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 Chapter 2 Getting Started 25 ACCU CHEK Spirit
78. f Roche 2005 Disetronic Medical Systems Inc All rights reserved 04632753001 V01 11 05 Swiss made
79. for cancelling a Scroll Standard Bolus during programming o f you do not press any key for 20 seconds your pump returns to the RUN screen timeout e Exit to the STANDARD BOLUS menu by pressing gt simultaneously e Set the bolus amount to 0 0 units Press to exit No bolus is delivered during the start delay _L is blinking e Press or A melody plays Your pump returns to the RUN screen An alert A8 BOLUS CANCELLED occurs Press GA 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 bolus delivery countdown of bolus amount e Press and hold or for 3 seconds until you hear a melody An alert A8 BOLUS CANCELLED occurs Press twice to confirm and turn off the alert Bolus delivery is interrupted Please refer to section Alert A8 BOLUS CANCELLED page 153 for more information Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump You can view the actual bolus amount delivered prior to the cancellation 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 Programming an Extended Bolus The Extended Bolus is available in the ADVANCED and C
80. he pump in STOP mode 2 The ACCU CHEK logo appears ACCU CHEK Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 3 OELF TEST appears SELF TEST 4 Your pump beeps and BEEP TEST appears BEEF TEST 0 Listen for the beeps j If you cannot hear the beeps from your insulin pump you may not be notified of changes with your insulin pump in CAUTION a suitable amount of time If you cannot hear the beeps contact Pump Support at 1 800 688 4578 5 Your pump vibrates and VIBRATION TEST appears WIEBRATIOM TEST cal Check for vibrations j If you cannot feel the vibration alert you may not be notified of any changes of your insulin pump in a suitable CAUTION amount of time If you cannot feel the vibration alert contact Pump Support at 1 800 688 4578 6 The display goes blank Check that the display is empty The backlight turns on during this step Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 7 The display shows a pattern Check that the pattern is even TERE ee ee cee ee ee SOLDER Ghose nae eben cane 8 The display turns black Check that the display is completely black 9 You will also see an INFORMATION screen Accu Chek Seirit i 10 If your pump detects an alert or error during the start up process it signals the error or alert at this point See the section Alerts and Errors page 147 for more information 11 A melody signa
81. hemicals such as e cleaning solutions e alcohol e beverages See the section Cleaning Your ACCU CHEK Spirit Insulin Pump page 141 for more information Avoid any contact of your insulin pump the infusion set and the connecting parts of your insulin pump with health CAUTION and beauty items for example antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics These items may discolor your pump or fog your display Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Starting Insulin Delivery stop E screen Follow the steps below 1 Start from the STOP screen M142 PhM esse gmh 2 Press G to move to the START YOUR ACCU CHEK screen START OUR ACCU CHEK 3 Press GA to select Your pump shows the RUN screen 1142P Insulin delivery begins within 3 minutes dha 1 2 Uh Note Check the amount of insulin remaining in the cartridge at least once a day If you press the key from the RUN or STOP screen your pump displays the remaining cartridge content in units Before going to sleep make sure that e the cartridge contains enough insulin to last through the night and e the time and date are set correctly Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump stopping Insulin Delivery When your insulin pump is in STOP mode it does not deliver any insulin You will need to put your insulin pump into RUN CAUTION
82. hould 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 pump in hyperbaric chambers and in hazardous areas of any kind such as areas where explosive or flammable gases or vapors could exist This could affect insulin delivery and or lead to harm Your pump is designed to work in normal barometric conditions from 700 to 1 060 mbar Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Do not exceed 10 000 feet 3 000 meters above sea level Your pump has not been tested for use above this level Always stop and remove your pump before you enter these areas If you have questions contact Pump Support at 1 800 688 4578 Sports and Exercise Exercise is an important part of diabetes management Disetronic Medical systems designed the ACCU CHEK Spirit insulin pump to let you safely perform many sporting activities while you wear your pump It is important that you protect your pump before you start exercise or sports activities Do not wear your pump during sports that involve body contact such as boxing football or hockey since rough contact could damage your pump Consult our sterile products brochures and accessories catalog for
83. in lt 50h U100 insulin lt 3 5U 400kPa 4 0 bar U100 insulin lt 1 0U 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 charger officially recommended by the battery manufacturer Shock scratch pharmaceutical resistant plastic All edges are rounded Determined using measurement methods according to IEC 60601 2 24 1998 Appendixes ACCU CHEK Spirit Insulin Pump Safety system Alert system beeps information on the display vibrations dual microprocessor The insulin pump is controlled by two microprocessors The safety concept is based on one processor Supervisor processor supervising the other main processor Whenever a defect or fault occurs in the main processor as identified by the supervisor processor the motor is immediately switched off and an error E7 ELECTRONIC ERROR occurs Conversely the main processor can also determine at any time whether the supervisor is working correctly The brushless motor also constitutes an important safety component It provides the best possible reliability and accuracy in insulin delivery Temperature ranges e During operation 41 F to 104 F 5 C to 40 C e Stored in its shipping case 41 F to 113 F 5 C to 45 C Temporary Basal Rate Adjustable in 10 increments 0 9
84. in pump has a Liquid Crystal Display LCD screen that displays important information Check the display at least every three hours during the day before you go to sleep and if you are not able to hear the beeps or alerts or feel the vibrations This is the only way you will be aware of important changes in your pump Chapter 1 Understanding Your New System 9 ACCU CHEK Spirit Insulin Pump A If you discover incomplete characters numbers or symbols on the display put your insulin pump into STOP mode and CAUTION perform a system check by simply removing the battery for a few seconds When you reinsert the battery the system check will occur If the incomplete characters numbers or symbols 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 To make the display easier to read you can flip the display orientation 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 Backlight The backlight helps you to see the display in poorly lighted areas You can turn on the backlight from the RUN screen from the STOP screen or when you are browsing the menus Press the key to turn on the backlight The backlight turns itself on when an alert or an er
85. infusion set 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 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Inserting the Cartridge i Do not perform the CHANGE THE CARTRIDGE function if the cartridge compartment is not completely dry During the CAUTION 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 STOP Gi change the G2 remove the 3se Q gt screen cartridge cartridge Dj returning piston rod S S cartridge volume WD 315 units start up procedure D prime the gt infusion set Have the following materials ready o Your insulin pump o A filled ACCU CHEK 3 15 ml plastic cartridge with a connected ACCU CHEK Spirit insulin pump adapter e A new ACCU CHEK infusion set Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Follow the steps below 1 Press amp to move to the STOP YOUR ACCU CHEK screen STOP YOUR ACC HEF En 2 Press to select and put the pump in STOP mode G 142PM 6 05 26 Your pump displays the STOP screen and in
86. insulin cartridge have dropped to 20 units of insulin Be prepared to replace the cartridge as soon as possible The cartridge low symbol appears in the RUN or STOP screen as a reminder until you change the cartridge 1 Press G amp A twice to turn off and to confirm the alert CARTRIDGE LOU Change the cartridge before it is empty PLEASE COHFIRM 2 If necessary put your pump in RUN mode See the section Changing the Cartridge and Infusion Set page 73 for more information Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump Alert A2 BATTERY LOW The battery power is low Be prepared for a battery change as quickly as possible The battery low symbol appears in the RUN or STOP screen as a reminder until you change the battery 1 Press GA twice to turn off and to confirm the alert Replace the battery as soon as possible within a few hours Failure to change the battery within a few hours of receiving the alert could result in additional error messages 2 If necessary put your pump in RUN mode 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 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 regar
87. it is damaged or lost Ask your insurance agent for details How to use this guide This guide is for version 2 XX of the ACCU CHEK Spirit insulin pump Note This user guide presents you with sample screens The screens in this user guide may look slightly different from your pump screens If you have questions about what you see on your pump contact Pump Support at 1 800 688 4578 When you become familiar with your pump you can quickly refer to the back of this user guide for tables and definitions that can help you to understand pump alerts and warnings and the symbols on the pump screen There is also a glossary at the back that defines terms used in this guide and a table that lists the technical specifications for your pump All of this information can help you and your doctor or healthcare team to understand the pump and use it 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 l WARNINGS are indicated by a triangle and the word WARNING WARNING n CAUTIONS are indicated by a triangle and the word CAUTION CAUTION a Working safely with your ACCU CHEK Spirit insulin pump Your ACCU CHEK Spirit insulin pump
88. keep the following points and warnings in mind e 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 package is damaged e Properly tighten the infusion set to the adapter to avoid leakage Turn the infusion set luer lock connector until it stops Do not turn it any further and do not use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage o Your pump cannot detect infusion set 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 healthcare team s instructions e Always disconnect your infusion set before changing a cartridge or priming You risk uncontrolled insulin delivery into your body Always follow the instructions for the infusion set you are using Have the following materials ready o Your ACCU CHEK Spirit insulin pump o A disinfectant for your skin e A new ACCU CHEK infusion set Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Follow the steps below 1 Wash your hands thoroughly 2 Make sure yo
89. keys when the KeyLock function is turned on k Unlocked keys when the KeyLock function is turned on eee Change the cartridge menu and cartridge content Ci Cartridge low warning hn Empty cartridge Et Low battery EF Empty battery Alkaline AA battery Rechargeable AA battery lth Amount of International Units of insulin delivered per hour th Basal rate profile th 4 Temporary Basal Rate F TBR percentage a Daily basal rate total Fd Basal rate programming unlocked T Basal rate programming locked Appendixes ACCU CHEK Spirit Insulin Pump L Standard Bolus and Bolus increment programming cl Extended Bolus and Extended delivery of the MultiWave Bolus h MultiWave Bolus le Immediate bolus delivery of MultiWave Bolus Decreased Temporary Basal Rate 0O 90 Remaining duration of an ongoing Extended Bolus MultiWave Bolus TBR or automatic off d Increased Temporary Basal Rate 110 200 Daily total of insulin delivered basal rate plus boluses E Prime the infusion set menu hy Alert or error occurring A Alert F Error il Information menu C2 Pump timer select the user menus STANDARD ADVANCED or CUSTOM i SETUP MENU STANDARD menu a SETUP MENU ADVANCED menu a Beeps turned on fei Vibrations turned on oi ea Beeps and vibrations turned on Appendixes ACCU CHEK Spirit Insulin Pump a T Set beep volume ES Screen orientation EU European date format US American date format Alarm clock
90. la or needle of the infusion set is placed under the skin usually in the abdominal area Recommended Possible Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Use only infusion sets that have a luer lock connector All current ACCU CHEK infusion sets have luer lock connectors and are the preferred choice for use with your ACCU CHEK Spirit insulin pump All ACCU CHEK infusion sets are PVC free are skin friendly and do not affect insulin The diameter of the ACCU CHEK infusion set tubing is small for fast priming and minimal waste of insulin ACCU CHEK infusion sets come in a wide 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 Seal inside the adapter Seal outside the 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 adapter will not work properly if the vents are plugged dirty or if the seals are worn or missing Change the adapter with at least every 10 cartridge change Also change the adapter if the seals become worn lost or if the vents become plugged Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Battery 6 1 Your pump runs on one
91. larm Clock page 127 SETUP MENU ADVANCED See the section SETUP MENU Advanced page 129 Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Basal Rate Profiles Your pump can store up to five different basal 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 Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Programming Additional Basal Rate Profiles Incorrect programming of your insulin pump may cause incorrect insulin delivery Your insulin pump must be WARNING programmed with your personal settings prior to starting insulin pump therapy Do not operate your insulin pump without knowing your personal settings If you are not sure about your personal settings or you are less experienced have your doctor or healthcare team check your personal settings Follow the steps below 1 Press G to move to the PROGRAM BASAL RATE PROFILE screen PROGRAM BASAL RATE FROFILE dh Note Only basal rate profiles that are accessible in your current user menu are available 2 The hourly basal rates for each additional basal rate profile are set in the same way as for basal rate profile 1 See the section Programming your Basal Rate Pr
92. ls 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 or until you hear a melody to turn the STOP Warning off Gitd2Prl m a526 ETO Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Note lf 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 or until the battery is dead j If you discover incomplete characters numbers or symbols on the display put your insulin pump into STOP mode and CAUTION perform a system check again by simply removing the battery for a few seconds When you reinsert the battery the system check will occur If the incomplete characters numbers or symbols 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 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump setting Time and Date Be careful to set the time and date correctly because the basal rates and all history information are stored on the basis of time and date set in the pump When you travel across time zones make sure that the time and date are set correctly The time for
93. mat can be either American or European Military Time American European Military Time 12 hour clock 24 hour clock month day year day month year i l Incorrect setting of time and date can lead to incorrect insulin delivery Make sure that the time and date of your WARNING 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 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 they are not the gathered data might not be meaningful Check these devices regularly to ensure that the time and date settings are identical Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump i AY RUN gt set the time Q2 aD screen and date 1 AD set the lt p minute 5 AN set the CED year l gt ENN a gt AO set the day Follow the steps below to set the Time and Date 1 Press G to move to the SET TIME AND DATE screen SET TIME AND lect ANE Press GA to select bj 2 The SET HOUR screen displays SET HOLIF Press or to set the hour co a BAEBRPTT AL 14 3 Press G to move to the SET MINUTE screen SET MINUTE E Press or to set the
94. mersion in water Ingress of water in quantities causing harmful effects is not possible when the device is temporarily immersed in water under standardized conditions maximum of 60 minutes a day and 8 feet 2 5 meters depth Luer lock connector A standardized fitting 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 mode During normal use your pump is in RUN mode and insulin is continuously delivered Boluses Temporary Basal Rates and almost all functions can be programmed from RUN mode RUN screen The RUN screen is the starting point for all functions that can be accessed while your pump delivers insulin Your pump displays the RUN screen during normal use when no programming is currently being performed The time current hourly basal rate basal rate profile and all functions currently activated appear on the RUN screen Appendixes ACCU CHEK Spirit Insulin Pump Settings Settings are individually programmable values and parameters that affect the way your pump works Scrolling Scrolling allows fast and easy programming of larger values STOP mode When your pump is in STOP
95. mode to continue insulin delivery There are functions and actions for your safety that you can only perform when the pump is in STOP mode These functions and actions include e changing the cartridge e connecting and disconnecting the adapter and or infusion set and e priming the infusion set Follow the steps below 1 Press amp to move to the STOP YOUR ACCU CHEK screen STOP YOUR ACCU CHEK T 2 Press to select Gdid2PP H A526 Your pump returns to the STOP screen and ETH insulin delivery stops 3 Press GA QUICK INFO screen to review activated functions and features like the beep and vibration alarm signals indicated by icons and messages on the screen Accu Chek Seirit O a iii U1 AH Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump 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 G twice for each appearing alert to confirm and turn off See the sections Alert A6 TBR CANCELLED page 152 and Alert A8 BOLUS CANCELLED page 153 for more information STOP Warning The STOP Warning is turned on by the pump each time your pump switches from RUN mode to STOP mode and when a battery is inserted The STOP Warning is a long beep and a vibration occurring every minute It warns you that insulin delivery
96. 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 across time zones make sure that the time and date on your pump are set correctly to the local time The ACCU CHEK insulin pump has not been tested at altitudes in excess of 10 000 feet 3 000 meters above sea level If your travels take you to an area in excess of 10 000 feet 3 000 meters above sea level stop and remove your pump This does not apply to use in airplanes with pressurized cabins If you have questions contact Pump Support at 1 800 688 4578 Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Your Insulin Pump and Water Avoid deliberate contact with water Check daily that your insulin pump is not chipped cracked or damaged in any CAUTION way and that the battery cover and the adapter are correctly closed In the presence of chips and cracks water dust insulin or other foreign substances may enter your insulin pump and lead to malfunction Prior to contact with water disconnect and take off your insulin pump Disconnect and remove your pump before entering a bathtub Jacuzzi or whirlpool shower or swimming pool Avoid exposing your pump to high
97. n and understand that your pump may not be returned to you Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Troubleshooting This section describes problems that may occur while using your ACCU CHEK Spirit insulin pump See Alerts and Errors page 147 for more information Note The solutions in this guide are only suggestions Do not use these procedures without approval of your doctor 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 an internal security check system it cannot alert you if your infusion set is leaking or if the insulin you are using has lost its potency Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Therapy Related Issues Many factors such as alcohol consumption medications other than insulin ineffective or expired insulin decreased activity illness and stress can affect blood glucose levels Contact your doctor or healthcare team for advice on how to manage these or any other therapy related issues Troubleshooting Table Recommended Actions Individual characters numbers or Contact Pump Support at symb
98. nd Alert A8 BOLUS CANCELLED page 153 for more information Make sure that the cancellation was intended and then program a new Extended Bolus and or Temporary Basal Rate if needed Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Programming a MultiWave Bolus The MultiWave Bolus function is available in the ADVANCED user menu It is designed to better simulate a body s insulin delivery It combines an immediate bolus delivery followed by an Extended Bolus delivery This function can be helpful when you have meals that include both rapid and slowly absorbed carbohydrates The duration of bolus delivery can be programmed in 15 minute intervals for up to 24 hours Note e The MultiWave Bolus is available in the ADVANCED user menu e You can add a Standard Bolus to an ongoing MultiWave Bolus If you cancel the Standard Bolus the MultiWave Bolus remains running e During the delivery of a MultiWave Bolus the programming of a second MultiWave Bolus or an Extended Bolus is blocked If you need a different MultiWave Bolus put your pump in STOP mode to cancel the current bolus and program a new one Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump AY CD MultiWave GO bolus bolus amount 3 sec AD gt bolus AY delivery immediate G or bolus stop your l gt MOY ACCU CHEK bolus duration 5 Sec delay GID i A8 bolus cancelled 1 Follow the steps below 1 Select the AD
99. nd accessories with you This allows you to exchange components when needed CAUTION Materials designed for single use such as cartridges and infusion sets should not be reused due to the increased risk of infections malfunctions and or incorrect insulin delivery See Disetronic Medical Systems sterile products and accessories catalogs and brochures for more information Or contact Pump Support at 1 800 688 4578 n Your insulin pump and its sterile products and accessories include small component pieces that could pose a choking WARNING hazard to children Keep sterile products and accessories out of the reach of children Cartridges Your pump is designed to use ACCU CHEK 3 15 ml plastic cartridges to hold insulin Do not reuse a cartridge Reusing sterile products could lead to infection or could damage your pump ACCU CHEK 3 15 ml plastic cartridges come with a protective cartridge cap as well as a filling needle and plunger rod to aid in filling cartridge plunger rod U KE plunger cartridge protective cap eo filling needle with protective cap Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump The cartridges are sterile products intended for single use only WARNING Infusion Set An ACCU CHEK infusion set connects your pump to your body to deliver insulin The insulin travels from the cartridge in your insulin pump through the infusion set into your body The cannu
100. ng conditions Do not place your insulin pump in direct sunlight Overheating of the insulin and your insulin pump must be avoided Protect CAUTION 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 are using to determine the acceptable temperature range Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump When Not to Wear Your Pump Electromagnetic Fields and Hazardous Areas Do not use your pump around electromagnetic fields such as radar or antenna installations high voltage sources X Ray sources MRI CAT scan and all other sources of electrical current as they may cause your pump not to work Insulin delivery may stop and an error E7 ELECTRONIC ERROR may occur Always stop and remove your pump before you enter these areas See Appendix A Technical Data page 165 for more information about electromagnetic fields A Your insulin pump has not been tested with cardiac pacemakers Do not use the ACCU CHEK Spirit insulin WARNING pump if you have a cardiac pacemaker Your pump has been tested and complies with the regulations regarding unintentional electromagnetic interference Security systems in airports as well as anti theft monitoring devices such as those in department stores s
101. nguage setting needs to be checked 1 Press G amp A twice to turn off and to confirm the error LAHSUAGE ERROR A E13 FLEASE COWFIRM 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 Appendixes Appendix A Technical Data General Technical Data Air humidity e During operation 20 to 90 relative humidity e Stored in its shipping case 5 to 85 relative humidity Barometric pressure During operation or stored in its shipping 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 ACCU CHEK Spirit Insulin Pump Bolus The max bolus amount per delivery is 25 units when using U100 insulin The bolus amount for the Quick Standard Bolus is adjustable in increments of 0 1 0 2 0 5 1 0 and 2 0 units For the Scroll Standard Bolus the Extended Bolus and the MultiWave Bolus the amount is adjustable in fixed increments of 0 1 units The duration of the Extended Bolus and the MultiWave Bolus is
102. o 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 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 of an infusion set that includes the soft cannula or needle The infusion set tubing connects either directly to the headset or connects to a shorter length of tubing permanently attached to the headset Hourly basal rate The amount of insulin delivered by your pump in 3 minute intervals for a given hour Infusion set Connects your pump to your body The insulin is delivered from the cartridge through the infusion set tubing and cannula or needle into your subcutaneous tissue Appendixes ACCU CHEK Spirit Insulin Pump Infusion site The place where the infusion set cannula or needle is inserted into your subcutaneous tissue to deliver insulin Insulin A hormone that helps cells turn glucose into energy Insulin is produced in the beta cells of the pancreas also called islets of Langerhans Insulin rapid acting insulin analog A type of insulin created using recombinant DNA technology The onset time of insulin analog is 5 to 15 minutes IPX8 according to IEC 60529 Protection against the effects of temporary im
103. o move to the BOLUS DURATION screen BOLUS DURATION Press gt to increase or decrease the 1 00 bolus duration O 2 5 Note Press G to loop between programming the bolus amount and bolus duration 5 Press to confirm the bolus amount and duration You will hear a melody when the bolus delivery begins within the next 3 minutes Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Note At any function screen you have three options to exit If you want to deliver the bolus e Press GD Your pump returns to the RUN screen If you want to cancel the bolus e Wait for your pump to return to the RUN screen timeout or e Press G D gt simultaneously exit feature to exit the function screen e Set the bolus amount to 0 0 units and press 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 Dal i2Pr ess oe 2 00 1 BGUsh Note lf a Temporary Basal Rate is active at the same time as the Extended Bolus the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen Dal i2Pr ess o 2 00 1 ZOUH Chapter 4 Boluses and TBRs 30 ACCU CHEK Spirit Insulin Pump Cancelling an Extended Bolus during programming the bolus amount or bolus duration blinks You have three options for cancelling an Exten
104. o the first menu choice 3 When you reach the screen displaying the choice you want e g SET THE TIME AND DATE press lt The next set of screens are called function screens They all relate to the choice you made There may be only one function screen or multiple screens 4 Press the or key to increase or decrease the selected value Or press the amp key again to move to the next function screen you want to change After you reach the last function screen you will loop back to the first function screen 5 Press to save your changes The pump returns to the RUN or STOP screen and the changes are saved Note The menu choices that appear depend on the menu that is selected Your pump can display a Standard Advance or Custom user menu See the section User Menus page 99 for more information Pressing G simultaneously lets you move backwards in the menu structure or to return to menus you just skipped If you are within a function screen pressing G simultaneously lets you move up to the corresponding menu without saving the current changes 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 pump also beeps when a key is pressed unless the beep volume is turned off The beep volume can be turned up or down Chapter 1 Understanding Your New System 5 ACC
105. ofile page 37 for more information Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Selecting a Basal Rate Profile AD C gt change the Q2 BR profile BR profile no Va RUN screen Follow the steps below 1 Press gt to move to the CHANGE BASAL RATE PROFILE screen CHAMHGE BASAL PATE PROFILE 2 Press to select PROFILE The current basal rate profile is displayed 45 AU Note Only basal rate profiles that are accessible in your current user menu are available 3 Press or to select a basal rate profile The selected basal rate profile and its daily insulin total appear 4 Press to select The new basal rate profile is active immediately Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Note When you change your user menu your current basal rate profile may not appear If the basal rate profile number s you want does not appear e Select the ADVANCED user menu or e 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 Alarm Clock You can set the alarm clock for a single alarm or for multiple alarms Multiple alarms repeat at the set time every day Alarms can be set to remind you of blood glucose testing or other important events Set Single or Multiple Alarms
106. ols on the display are shown 1 800 688 4578 incompletely or not at all Your insulin pump does not beep Check that the beep volume and alarm or vibrate 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 self test incomplete after an error Remove the battery wait a few E7 ELECTRONIC ERROR seconds and insert it again If the self test remains incomplete contact Pump Support at 1 800 688 4578 Incorrect insulin delivery due to The correct hourly basal rate cannot be incorrect time setting delivered if the time is not set correctly Check and reset the time if it is wrong Do the same check when you change the battery Incorrect insulin delivery due to Always review changes made in basal incorrect basal rate programming rate programming Confirm that you are using your correct basal rate profile Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Recommended Actions Air bubbles in the cartridge Check blood glucose level In the and or infusion set cartridge Disconnect the infusion tube set from the headset and re prime your infusion tube set If the air bubbles remain replace the cartridge Make sure to fill the cartridge with insulin at room temperature n the infusion set Disconnect and prime your infusion set Reconnect and make sure all connections are tight and secure Blood in the infusion
107. on 1 Press G amp A twice to turn off and to confirm the error EHD OF _OFPERAT DOH ES es FETIJEH ACCU CHEE Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump 2 Contact Pump Support at 1 800 688 4578 to discuss your options for further use of the ACCU CHEK Spirit insulin pump Note The alert A5 PUMP TIMER ALERT and the error E5 END OF OPERATION are based on running time the total time the pump is in RUN mode and not calendar years However the warranty is based on the date the pump was purchased Error E6 MECHANICAL ERROR A mechanical error was discovered during a routine automatic system check and insulin delivery has stopped 1 Press G amp A twice to turn off and to confirm the error MECHAMICAL ERROR A E6 e PLEASE COHFIRH 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 Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump If the error E6 MECHANICAL ERROR occurs again in spite of these actions contact your doctor or healthcare team for an alternate therapy plan Contact Pump Support at 1 800 688 4578 for more assistance Error E7 ELECTRONIC ERROR
108. one beep in STOP mode to confirm that the KeyLock is unlocked OAS sSPr dh O SUsh a 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 MA5 65PTM din 0 5 Uh Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Adjusting the Beep Volume Your pump beeps when a key is pressed or when an alert or error occurs Follow the steps below 1 Press G to move to the SETUP MENU STANDARD screen SETUP MEHU Press to select STANDARD _ 2 Press amp D to move to the BEEP VOLUME screen BEEF VOLUME The active beep volume is displayed HAs q 3 Press or to adjust the beep volume There are five volume levels 4 no beeps beeps are turned off d very low di OW d Normal Ji Maximum 4 Press GA 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 increase in volume until the maximum level is reached if the alert or error is not cancelled Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Setting Up Alarm Signals The ACCU CHEK Spirit insulin pump lets you choose how you want your pump to alert you when an alarm occur
109. or error occurs Chapter 7 Alerts and Errors 43 ACCU CHEK Spirit Insulin Pump Confirming an Alert or Error When you confirm A1 CARTRIDGE LOW Ck E1 CARTRIDGE EMPTY A2 BATTERY LOW mex E2 BATTERY DEPLETED A5 PUMP TIMER 2 or E5 END OF OPERATION the symbol for that alert or error stays in the RUN screen or STOP screen as a reminder For other alerts or errors alarm information is cleared from the display but stays in the alarm history and the event memory Follow the steps below to confirm an alert or error 1 Press to turn off the beeps and vibrations CARTRIDGE LOW The alert or error code stays on the display PLEASE COHFIRM 2 AS soon as you understand the reason for the alert error code or message confirm by pressing again 3 lake the appropriate action if any 4 lf more than one alert and or error occurs simultaneously press twice for each alert or error to confirm and turn each off 5 After an alert or error make sure that your pump is returned to RUN mode Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump List of Alerts j After an alert occurs your insulin pump may be in STOP mode and the insulin delivery may be interrupted In order WARNING to maintain insulin delivery you must act immediately according to the instructions given for each error code or put your insulin pump in RUN mode to continue the insulin delivery Alert A1 CARTRIDGE LOW The contents of the
110. p mechanism If you CAUTION have questions contact Pump Support at 1 800 688 4578 If you have problems with your pump contact Pump Support at 1 800 688 4578 Pump Support can help you and answer many questions over the telephone Pump Support may direct you to return your pump to Disetronic Medical Systems for repair For example you might need to return your pump if an alert or error could not be cleared by following the procedures described in Alerts and Errors page 147 If Pump Support directs you to return your pump they will give you a Return Material Authorization RMA number that you must include with the pump when you send it If you must ship your pump carefully pack the pump and the used cartridge battery battery cover adapter and infusion set to avoid damage to them during transportation Place your pump back in the shipping case and put the case in a package that will not rip or tear It is best to send your pump using a shipping method and carrier that tracks the shipment When you return your pump include the following e a description of the reason for returning your pump e your name and address e your daytime phone e the serial number of your pump and e any RMA Return Material Authorization number received from Pump Support By returning your pump to Disetronic Medical Systems you allow Disetronic Medical Systems to undertake any testing on your infusion pump that is needed for a proper inspectio
111. products intended for single use only Sterility is guaranteed for unopened WARNING packaging up to the indicated expiration date Do not use Sterile products if the packaging is damaged Do not reuse single use materials because this might lead to a malfunction of your insulin pump to incorrect insulin delivery and or 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 Chapter 2 Getting Started 47 ACCU CHEK Spirit Insulin Pump Follow the instructions below Remove the protective cap from the cartridge Do not touch the cartridge tip Push the adapter all the way onto the cartridge tip to the stop a Hold the adapter and twist the infusion set luer lock connection by hand clockwise into the adapter b Carefully prepare a new ACCU CHEK infusion set for use priming and insertion following its instructions for use Do not over tighten To avoid leakage properly tighten the infusion set to the adapter Turn the infusion set luer lock connector until it CAUTION stops Do not turn it any further and do not use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage Note Your pump cannot detect infusion set leakage You must check all parts of the
112. r ACCU CHEK Spirit Insulin Pump The best time to clean your pump is when you change the cartridge Use a soft dry cloth for cleaning If the pump compartments are very dirty contact Pump Support at 1 800 688 4578 for more instructions n Always remove the cartridge and adapter and place your insulin pump in STOP mode while cleaning Avoid pressing CAUTION the keys of your insulin pump during cleaning as this may accidentally change your settings Do not use alcohol solvents strong detergents bleaching agents scouring pads or sharp instruments for cleaning as they may damage the pump Battery Information It is important to change your battery regularly and to have spare batteries ready The life of any battery is 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 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 Chapter 6 Care and Maintenance ACCU CHEK Spirit Insulin Pump Repair Do not perform any servicing or repair on your insulin pump Do not use any lubricants on the pum
113. re information Inspect your infusion site at least once or twice each day for irritation or infection Signs of infection may include but are not limited to pain lumps redness heat or discharge If you see redness or swelling change the infusion headset and the infusion site immediately and contact your doctor or healthcare team Change the infusion headset according to the instructions for the infusion set you are using and your doctor or healthcare team s recommendations Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump Changing the Cartridge and Infusion Set Have the following materials ready o Your ACCU CHEK Spirit insulin pump o A disinfectant for your skin e A new ACCU CHEK infusion set o A filled ACCU CHEK 3 15 ml plastic cartridge with a luer lock connection e A new adapter must be changed at least with every 10 cartridge 1 Wash your hands thoroughly 2 Make sure your insulin pump is in STOP mode Sider mM 05 26 TOE 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 the luer lock connector between your infusion set and adapter if it cannot be loosened by hand Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump 5 Hold your ACCU CHEK Spiri
114. rogrammed basal rate it is active immediately Basal Rate and Bolus During normal use your pump is in RUN mode and insulin is continuously delivered 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 Boluses page 75 for more information Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Preparing the Cartridge Your insulin pump is designed to use an ACCU CHEK 3 15 ml plastic cartridge The cartridge is a sterile product WARNING intended for single use only Sterility is guaranteed for unopened packaging up to the indicated expiration date e Do not use sterile products if the package is damaged e 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 ACCU CHEK Spirit Insulin Pump Filling the Cartridge Note A filling aid an optional accessory by Disetronic Medical Sys
115. ror message appears The backlight turns itself off after 30 seconds if no keys are pressed Hint Start programming with the key in areas of poor lighting as this will also turn on the backlight Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Keys and Key Combinations The pump will beep each time a key is pressed unless the beep tone is set to 0 A Never press any of the keys with a sharp or pointed item such as the tip of your fingernail This could damage the CAUTION casing of your insulin pump Use the pad of your fingertip instead to avoid puncturing the keys Single Keys Each key has a specific function when it is pressed by itself The following table describes the function of each Key Name Function GD scrolling through menus functions and information screens se ecang a menu e saving aha i s and exiting screen e viewing the QUICK INFO screen e increasing a setting e moving forward in the information screens e turning on the backlight Down e decreasing a setting e moving backward in the information screens a SB Either or can be used for programming or cancelling a Standard bolus Pressing either key for 3 seconds until you hear a melody will also temporarily turn off the STOP Warning Chapter 1 Understanding Your New System i ACCU CHEK Spirit Insulin Pump Note Increase or decrease the values by pressing the or keys If you want to
116. rrors No Error What You Need to Do E1 CARTRIDGE EMPTY Change the cartridge E2 BATTERY DEPLETED Change the battery E3 AUTOMATIC OFF If necessary put your ACCU CHEK Spirit in RUN 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 options for further use of the ACCU CHEK Spirit insulin pump Contact your healthcare professional for alternative insulin therapy options E6 MECHANICAL ERROR See the section Error E6 MECHANICAL ERROR E7 ELECTRONIC ERROR See the section Error E7 ELECTRONIC ERROR E8 POWER INTERRUPT See the section Error E8 POWER INTER RUPT E10 CARTRIDGE ERROR See the section Error E10 CARTRIDGE ERROR E11 SET NOT PRIMED Prime your infusion set E12 DATA INTERRUPTED Restart the data transfer E13 LANGUAGE ERROR See the section Error E13 LANGUAGE ERROR Quick Reference Table for Errors ACCU CHEK Spirit Insulin Pump Stopping Insulin Delivery 66 Priming 55 System Check 28 31 Temporary Basal Rate Cancelling 97 History 111 Over 96 153 Programming 93 96 Time and Date 32 American 32 130 European 3
117. ry e You can cancel the immediate delivery by pressing and holding lt gt or for 3 seconds until you hear a melody This cancels the whole bolus immediate and Extended Bolus delivery An alert A8 BOLUS CANCELLED occurs Chapter 4 Boluses and TBRs J ACCU CHEK Spirit Insulin Pump Note If the alert A8 BOLUS CANCELLED does not occur the bolus delivery was not cancelled Cancel the extended delivery see below e You can cancel the extended delivery by putting the pump in STOP mode This cancels the Extended Bolus An alert A8 BOLUS CANCELLED occurs Press SA twice to confirm and turn off the alert Bolus delivery is interrupted see the section Alert A8 BOLUS CANCELLED page 153 for more information You can review the actual bolus amount delivered before the cancellation by looking at the bolus history See the section Review the Bolus History page 107 for more information A When your insulin pump is in STOP mode it does not deliver any insulin Put your insulin pump in RUN mode to continue CAUTION the insulin delivery Note lf a Temporary 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 GA twice to confirm and turn off the first alert The second alert appears on the display Press twice to confirm and turn off the second alert Both alerts are recorded in the alarm history
118. s You have three options q beep only fei vibrate only 1 lic beep and vibrate Follow the steps below 1 Press G to move to the SETUP MENU STANDARD screen SETUP MEHU Press GA to select STANDARD _ 2 Press G to move to the ALARM SIGNALS screen ALARM ia The active alarm signals are displayed ici BEEF AND WIERATE 3 Press or to set the alarm signals 4 Press GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Automatic Off Discuss using the automatic off function with your doctor or healthcare team CAUTION Automatic off is a safety feature that stops insulin delivery and triggers an error E3 AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode The automatic off can either be set to OFF or programmed up to 24 hours in 1 hour intervals in the SETUP MENU STANDARD screen Follow the steps below 1 Press G to move to the SETUP MENU STANDARD screen SETUP MEHU Press GA to select STANDARD _ 2 Press amp D to move to the AUTOMATIC OFF screen AUTOMATIC OFF The current status is displayed at the bottom hi left of the screen OFF 3 Press or scroll to increase or to decrease the duration for the automatic off in 1 hour intervals AUTOMATIC OFF Fi Or 4 If you would like to set the automatic off function to OFF press or scroll gt until 0 hours and OFF appears on the display 5 Pres
119. s GA to save and exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Battery Type j If you do not set the correct battery type on your insulin pump the alert A2 BATTERY LOW may not occur in time WARNING to provide you sufficient warning to replace your battery Your pump lets you choose between using 1 5 volt AA alkaline batteries or rechargeable AA NiMH batteries If you change from one battery type to the other you must also change the battery type setting see the section Accessories and Disposables Battery page 21 for more information on recommended batteries Follow the steps below 1 Press G to move to the SETUP MENU STANDARD screen SETUP MEHU Press GA to select STANDARD _ 2 Press amp D to move to the BATTERY TYPE screen BATTERY TYPE The current battery type is displayed BATTERS ALKALIWE 3 Press or to select the battery type ALKALINE or NiMH rechargeable battery BATTERY TYPE Press to save and exit TE HIMH RECHARGE Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Display Orientation Your pump lets you flip the display orientation by 180 so that you can view it more conveniently depending on how you are wearing the pump Follow the steps below 1 Press G to move to the SETUP MENU STANDARD screen SETUP MEHU Press to select STANDARD _ 2 Press amp D to move to the ORIENTATION screen ORIENTATION
120. s off For more information see the section Turning KeyLock On or Off page 113 Screens Your pump displays various screens on its display for you to access information and functions RUN Screen basal rate current hourly time basal rate ji 3151 i 0 UW Uh Om 27 gt a KeyLock locked pump timer cartridge low battery low active basal rate profile During normal use your pump is in RUN mode and insulin is delivered into 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 cartridge low and special functions such as KeyLock locked or unlocked in the form of symbols See the sections Starting Insulin Delivery page 65 for instructions on starting your pump and Appendix F Symbols page 183 for more information about the symbols Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump STOP Screen time date Sa7i5aPM A729 gmp ES OM 22 w KeyLock unlocked pump timer cartridge low battery low The STOP screen shows the current time and date the STOP symbol reminder information such as
121. s to exit If you want to save the changes e Press VA Check the new daily basal rate total e Press VA Your pump returns to the RUN screen If you want to undo the changes e Wait for your ACCU CHEK Spirit insulin pump to return to the RUN screen timeout or e Press D simultaneously exit feature to exit the function screen Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump Copying an Hourly Basal Rate If your basal rate is the same for multiple hours in a row you can save time programming by copying an hourly basal rate to one or more hours Follow the steps below 1 Press G to move to the PROGRAM BASAL RATE PROFILE 1 screen FROGRAM BASAL FATE FROFILE dh 2 Press to select BASAL RATE TOTAL The daily BASAL RATE TOTAL is displayed amp 16 00 3 Press amp D to move to the hourly basal rate you want to copy THH HA A1 H dh O 6Ush 4 Press simultaneously 610G B2 0A A special beep confirms that you are pressing dh O 6Ush 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 5 repeatedly or press and hold scroll Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 6 Press to confirm BASAL RATE TOTAL Check the new daily BASAL RATE TOTAL de 14 4 7 Press G amp A to save and exit lf the current active basal rate profile is the same as the new p
122. sened by hand However never use the battery key to attach or to tighten an infusion set The battery key has a notch that fits all ACCU CHEK infusion set luer lock connectors The battery key should be replaced if it cracks becomes worn or if it is lost Emergency Kit It is a good idea to carry supplies in case of an emergency so that you can exchange parts if you need to An emergency kit might contain e A new ACCU CHEK infusion set e A new AA alkaline battery e A new ACCU CHEK 3 15 ml plastic cartridge e A pen or syringe for alternate therapy e A vial of insulin e A filling aid e Treatment for low blood glucose levels e Blood glucose monitoring supplies such as an ACCU CHEK blood glucose monitor e A disinfectant for skin e A new site dressing e The battery key This list is only an example of what an emergency kit might contain Ask your doctor or healthcare team what supplies you should keep in your personal emergency kit Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump This page left blank intentionally Chapter 1 Understanding Your New System CCU CHEK Spirit Insulin Pump Chapter 2 Getting Started Inserting or Changing the Battery Your pump turns on when you insert the battery When you remove the battery your pump still tracks the time and date for about 1 hour The pump will always store your pump settings such as the hourly basal rates bolus increment and active us
123. set tubing Change your infusion set and infusion site Empty cartridge Replace the cartridge Cartridges are for single use only Disconnected or dislodged Make sure all connections are tight Inspect infusion set connections for leaking insulin Check your blood glucose level Change your infusion set and infusion site Leak in system Check for leaking insulin at all connections and on the skin Change your infusion set infusion site cartridge and adapter Check your blood glucose level Chapter 6 Care and Maintenance 145 ACCU CHEK Spirit Insulin Pump Recommended Actions Occlusion in system Disconnect and re prime your infusion set Check your blood glucose If the occlusion remains prime the pump without the cartridge inserted See the section Error E4 OCCLUSION page 156 Failure to complete prime Re prime the infusion set Always prime until a bubble free insulin flow emerges from the tip of the needle Make sure the tubing is free of air Poor absorption of insulin 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 Infusion site becomes sore Change your infusion headset and infusion red or swollen site immediately Use proper insertion technique Check blood glucose level Follow the planned infusion site rotation pattern and advice given by your doctor or h
124. stem 9 The ACCU CHEK Spirit Insulin Pump 9 Display 9 Backlight 10 Keys and Key Combinations 11 Screens 13 STATUS Screen Messages Beeps and Vibrations 15 Alarm Signals 16 Accessories and Disposables 17 Emergency Kit 23 Chapter 2 Getting Started Inserting or Changing the Battery 25 System Check Start Up Process 28 Setting Time 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 49 Priming the Infusion Set 53 Preparing the Infusion Site and Inserting the Infusion Set 56 Chapter 3 Using Your Pump Before Using 59 Wearing Your Pump 59 When Not to Wear Your Pump 61 Your Insulin Pump and Water 63 Starting Insulin Delivery 65 Stopping Insulin Delivery 66 Interruption of Insulin Pump Therapy 68 o Changing the Infusion Set 70 Changing the Cartridge and Infusion Set 73 Chapter 4 Boluses and Temporary Basal Rat 75 Understanding Boluses 75 Programming a Standard Bolus 77 Programming an Extended Bolus 83 Programming a MultiWave Bolus 88 Programming a Temporary Basal Rate TBR 93 Chapter 5 User Menus Selecting a User Menu 100 STANDARD User Menu 103 Data Transfer 104 Setup for Data Transfer 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 Menu 13
125. stem and therapy These products are designed for safe and simple insulin pump therapy Always follow the instructions given by your doctor or healthcare team for the use of all system components Use your ACCU CHEK Spirit insulin pump sterile products and accessories for the first time in the presence of your doctor or healthcare team Sterile Products Each sterile product should be used only once Reusing these products could lead to infection or could damage your 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 A Your insulin pump was designed for use with U100 insulin Only use sterile products and accessories that are designed WARNING for use with your insulin pump The proper functionality of your insulin pump can only be guaranteed if you use ACCU CHEK brand sterile products and ACCU CHEK Spirit accessories All ACCU CHEK brand sterile products and accessories designed for the ACCU CHEK Spirit insulin pump have been thoroughly tested and approved for use with your insulin pump Other sterile products and accessories have not been tested for compatibility with your insulin pump and if used may therefore endanger your health or void your warranty Chapter 1 Understanding Your New System ACCU CHEK Spirit Insulin Pump Always have extra sterile products a
126. sulin delivery stops 3 Press amp D to move to the CHANGE THE CARTRIDGE screen ZHAHGE THE CARTRIDGE 4 Press to select Remove the current cartridge if there is one 5 Press and hold amp 2 for 3 seconds until you hear a melody PETRINE The piston rod begins its return Do not touch or PISTON ROD disturb the piston rod while it is rewinding Doing so may potentially damage your pump CARTRIDGE VOLUME When the piston rod returns completely the mm i 3U CARTRIDGE VOLUME screen displays the maximum cartridge volume 315U Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 6 Hold your pump upright Hold the new filled cartridge so that the connected adapter and infusion tube set point upwards parallel and close to the cartridge compartment Make sure that the bottom edge of the colored part of the adapter is level with the top of the cartridge compartment Base plate of Cartridge plunger piston rod ee 7 Press or to move the plunger rod forward until the end plate of the piston rod is level with the bottom of the cartridge plunger CARTRIDGE VOLUME The cartridge volume decreases accordingly es I on the display MEE 8 Position your insulin pump upright with the adapter 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
127. t insulin pump with the adapter pointing downwards 6 Remove the adapter and cartridge from your pump by unscrewing the adapter from the pump casing Pulling the adapter from the pump casing without completely unscrewing it may result in the plunger staying attached to the piston rod If this should happen please call Pump Support at 1 800 688 4578 7 Remove the cartridge from the adapter and dispose of the cartridge properly 8 Hold the adapter up to the light to check for signs of wear or dirt especially on the seals inside and outside of the adapter It is recommended that you replace the adapter at least every 10 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 Cartridge page 49 Priming the Infusion Set page 53 Preparing the Infusion Site and Inserting the Infusion Set page 56 and Starting Insulin Delivery page 65 Note Check the amount of insulin remaining in the cartridge at least once a day Press the key from the RUN or STOP screen to display the remaining cartridge content in units Before going to sleep make sure that e the cartri
128. tal 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 A variety of special carrying systems made of different materials are designed to suit your individual needs while wearing your pump Cartridge The insulin reservoir of your pump It holds 3 15 ml of rapid acting insulin analog When using U100 insulin 3 15 ml is equal to 315 International Units of insulin Cartridge compartment The opening in your pump for the cartridge Appendixes ACCU CHEK Spirit Insulin Pump Daily insulin total The total amount of insulin delivered basal rate plus boluses in a 24 hour day beginning at midnight This amount does not include any insulin needed for the priming of infusion sets Diabetes Data Management DDM Diabetes Data Management is the recording of the therapy relevant data gained from your insulin delivery system and your blood glucose measurement system such as an ACCU CHEK blood glucose monitor in order to analyze and illustrate this data on a PC or other communication device Factory settings The standard configuration factory settings on a new pump These settings can be adapted to your individual needs directly on your pump Filling aid An accessory that can be used t
129. tems 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 To fill a cartridge have the following materials ready e A new 3 15 ml plastic cartridge with protective cap plunger rod filling needle and e Insulin at room temperature to minimize formation of air bubbles Follow the steps below 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 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 3 Remove the cartridge the cartridge protective cap and the filling needle with its protective cap from their packaging 4 Place the filling needle with protective cap onto the cartridge tip and make sure the connection is tight Move the plunger rod back and forth twice in the cartridge to distribute the lubricant Pull the plunger back to fill the cartridge with air Plunger Plunger rod 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 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump 6 Hold steady pressure against the plunger rod with your thumb and
130. th a cartridge adapter and a new infusion set and put it in the RUN mode if necessary Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Note Your pump returns to STOP mode 15 minutes after the last data transfer when the DATA TRANSFER screen is selected You may press G 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 Reviewing Pump Data The pump memory lets you review specific data such as e Bolus history last 30 boluses e Alarm history last 30 alerts and errors e History of daily insulin totals last 30 daily totals of insulin delivered e Temporary Basal Rate history last 30 increases and decreases e Maintenance pump timer remaining time 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 BOLUS HISTORY L ru H1 88 THPS4HPM A 11729 Each BOLUS HISTORY screen displays the e bolus type _L Standard Bolus Extended Bolus or h MultiWave Bolus e bolus duration only displayed if an Extended or a MultiWave Bolus e time e date fz and e entry number 01 is the most recent of total entries example 01 30 of a
131. tions Alert A6 TBR CANCELLED page 152 and Alert A8 BOLUS CANCELLED page 153 for more information Make sure that the cancellation was intended and then program a new Temporary Basal Rate and or an Extended or MultiWave Bolus if needed Chapter 4 Boluses and TBRs ACCU CHEK Spirit Insulin Pump Chapter 5 User Menus You will need to access various screens so you can view stored information program the pump perform a function or change a setting Your pump offers a choice of three different user menus e The STANDARD User Menu This menu offers all the functions you need for successful insulin pump therapy and lets you change between the user menus If you are new to pump therapy start with this menu Later as your comfort with pump therapy grows you may choose the features offered in the ADVANCED user menu e 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 e 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 choices This menu lets you display or hide other screens Note At the end of this user guide you will find diagrams for the STANDARD and ADVANCED user menus For your safety and convenience during programming your insulin
132. tridge Follow the steps below 1 Press 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 infusion site 5 Put your pump in RUN mode Chapter 7 Alerts and Errors ACCU CHEK Spirit Insulin Pump If the error E4 OCCLUSION occurs again prime your pump without a cartridge Follow the steps below 1 Press G2 twice to turn off and to confirm the error 2 Disconnect or remove the infusion set from your infusion site 3 Remove the cartridge adapter and infusion set from your pump 4 Carry out the PRIME THE INFUSION SET function without the cartridge adapter and infusion set inserted 5 Insert a new cartridge with connected adapter 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 and will no longer operate An error E5 END OF OPERATION will appear on the display It is recommended that you replace your pump after four years Before this error occurs an alert A5 PUMP TIMER will remind you to replace your pump so
133. ture Flow ml h 0 0200 0 0150 0 0100 0 0050 0 0000 0 200 400 600 800 1000 1200 1400 Time min Influence of height on delivery accuracy The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is lt 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 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 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 Percentage error of flow Observation interval min The average deviation of the delivered amount overall mean percentage flow error for U100 insulin is lt 20 Appendixes ACCU CHEK Spirit Insulin Pump Start up graph over the stabilization period The start up graph shows changes in the flow rate over the stabilization time 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 Flow ml h 0 0025 0 0020 0 0015 0 0010 0 0005 0 0000 0 200 400 600 800 1000 1200 1400 Time min Bolus For U100 insulin the delivery accuracy of a maximum bolus is lt
134. uctions Put your pump into RUN mode if necessary n Using AA batteries other than those recommended by Disetronic Medical Systems may significantly reduce the CAUTION battery usage time Batteries other than those recommended may leak and corrode the battery contacts 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 Chapter 2 Getting Started ACCU CHEK Spirit Insulin Pump system Check Start Up Process Your pump performs internal tests at start up when you insert a battery and when you change the cartridge When you insert a battery the whole start up process is performed When only the cartridge is changed the start up process begins at the SELF TEST screen n Do not interrupt the start up process by pressing keys or by handling the insulin pump Interruption of the WARNING start up process may lead to malfunctions of your insulin pump If your insulin pump does not beep and vibrate as described or if individual numbers letters symbols or lines are shown incompletely or not at all contact Pump Support at 1 800 688 4578 Note While you are using the pump its 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 1 Put t
135. ulin Pump Note 1 At 80 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 radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength 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 strengths should be less than 10 V m V in V 10 00 E in V m 10 00 Rated maximum 150 kHz to 80 MHz 80 MHz to 80 MHz to output power lout of ISM Industrial 800 MHz 2 5 GHz of transmitter W Scientific Medical Band Separation distance according to frequency of transmitter m 0 01 0 04 0 04 0 07 0 1 0 11 0 11 0 22 1 0 35 0 35 0 70 10 1 11 1 11 2 21 100 3 90 3 90 7 00 Appendixes ACCU CHEK Spirit Insulin Pump Technical
136. ur pump is in STOP mode D 1142P m 05 26 ETIR 3 Remove the infusion tube set from the headset 4 Remove the infusion tube set from the adapter and dispose of it properly T 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 adapter if it cannot be loosened by hand 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 Chapter 3 Using Your Pump ACCU CHEK Spirit Insulin Pump 8 Prime the infusion set following all the instructions and warnings found in the section Priming the Infusion Set page 53 9 Insert a new infusion set following the instructions found in the section Preparing the Infusion Site and Inserting the Infusion Set page 56 10 Remove the old infusion headset and dispose of it properly 11 Place the pump in RUN mode See the section Starting Insulin Delivery page 65 Note lf 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 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 mo
137. w the entries TER HISTORY it TER HI E Press to exit b GS THM4i52PM 2s Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump Review the Time Remaining Your pump is designed to be a highly reliable system that will give you worry free performance for a long time For best performance a pump timer limits the operating time of the pump This timer counts the number of days of operation remaining for the ACCU CHEK Spirit insulin pump Before the pump timer expires an alert will remind you of the upcoming end of operating time so that you can arrange to get a new one The pump timer symbol C 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 steps below 1 Press G to move to the INFORMATION screen IMFORMAT IO Press GA to select 2 Press G to move to the PUMP TIMER screen FUME TIMER The days until the pump timer expires is shown 2074 DAYS 3 Press to exit Chapter 5 User Menus ACCU CHEK Spirit Insulin Pump SETUP MENU Standard The SETUP MENU Standard should not be confused with the STANDARD user menu The SETUP MENU Standard is a menu choice that appears in S
138. your doctor or healthcare team successful insulin pump therapy requires you to check your blood glucose levels often It is a good idea to check your blood glucose using an ACCU CHEK blood glucose monitor at least four times a day or as often as you are directed by your doctor or healthcare team Wearing Your Pump A When wearing your insulin pump make sure to prevent any contact with objects that may damage or accidentally CAUTION press the keys of your insulin pump e g keychains keys pocket knives and coins Attach your pump safely to your body or clothes to prevent damage Special carrying systems let you carry your pump on or under your clothes All specified accessories have been tested and approved for use with 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 Chapter 3 Using Your Pump 59 ACCU CHEK Spirit Insulin Pump Wear your pump under your clothes or directly on your body in cold or rainy weather If you have concerns about the weather affecting your pump check the operating conditions of your pump and contact Pump Support at 1 800 688 4578 See the section Appendix A Technical Data page 165 for more information on operati

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