Accu-Chek Spirit User Manual Download

Page: 1 / 226

INSULIN PUMP

User Guide

Summary of Contents for Spirit

Page 1: ...INSULIN PUMP User Guide ...

Page 2: ...The Accu Chek Spirit At a Glance Display Up key Down key Infusion set Adapter Cartridge Check key Menu key This user s guide is valid for version 2 XX of the Accu Chek Spirit ...

Page 3: ...ique Therefore it is important that you your doctor or healthcare team fill in the following information Serial number of your Accu Chek Spirit insulin pump Insulin name type Accu Chek Spirit Training Place Date s Trainer Useful addresses Your contact for medical emergencies and or information about insulin pump therapy doctor healthcare team Phone ...

Page 4: ...venue Castle Hill NSW 2154 Australia Phone 61 2 9846 0100 Techn Support 1800 802 409 Orders Fax 1800 066 598 Orders sydney accu chekextra roche com www rochediagnostics com au New Zealand Roche Diagnostics N Z Ltd P O Box 62 089 15 Rakino Way Mt Wellington Auckland New Zealand Phone 64 9 276 4157 Fax 64 9 276 8917 info accu chek co nz www accuchek co nz South Africa Roche Products Pty Ltd Diagnost...

Page 5: ... secure use 18 2 1 5 Warnings and cautions about environmental hazards 20 2 1 6 Warnings and cautions regarding safe battery use 21 2 1 7 Warnings and cautions about wearing the insulin pump 22 2 2 Guarantee 23 3 The Accu Chek Spirit insulin pump 25 3 1 Display 25 3 2 Backlight 26 3 3 Keys and key combinations 26 3 4 KeyLock 29 3 5 Scrolling 30 3 6 STATUS screen 31 3 7 Alarm signals 31 3 8 RUN and...

Page 6: ...er menu STANDARD ADVANCED or CUSTOM 75 6 1 The three levels of the Accu Chek Spirit 75 6 2 Navigate through the menus 76 6 2 1 Scrolling 77 6 2 2 Looping 77 6 2 3 Backward loop 77 6 2 4 Exit options 77 6 2 5 Select a user menu 78 7 STANDARD user menu 83 7 1 Set time and date 83 7 2 Basal rate 87 7 2 1 Program a basal rate profile 88 7 2 2 Copy an hourly basal rate 90 7 2 3 Basal rate and bolus 91 ...

Page 7: ... Review the temporary basal rate history 117 7 8 5 Review the time remaining 118 7 8 6 Quick info screen 119 8 ADVANCED user menu 121 8 1 Extended bolus 122 8 1 1 Program an Extended bolus 123 8 1 2 Cancel an Extended bolus 124 8 2 MultiWave bolus 126 8 2 1 Program a MultiWave bolus 127 8 2 2 Cancel a MultiWave bolus 129 8 3 Basal rate profiles 131 8 3 1 Set an additional basal rate profile 131 8 ...

Page 8: ... Error E3 AUTOMATIC OFF 153 10 2 4 Error E4 OCCLUSION 154 10 2 5 Error E5 END OF OPERATION 157 10 2 6 Error E6 MECHANICAL ERROR 158 10 2 7 Error E7 ELECTRONIC ERROR 159 10 2 8 Error E8 POWER INTERRUPT 160 10 2 9 Error E10 CARTRIDGE ERROR 161 10 2 10 Error E11 SET NOT PRIMED 162 10 2 11 Error E12 DATA INTERRUPTED 163 10 2 12 Error E13 LANGUAGE ERROR 164 11 Troubleshooting 165 12 Life with your Accu...

Page 9: ...179 14 2 2 Battery information 179 14 3 Storing your Accu Chek Spirit insulin pump 180 14 4 When your insulin pump is dropped 181 14 5 Repair 182 14 6 Disposal 183 15 Technical data 185 15 1 General technical data 185 15 2 Technical standards on electromagnetic emissions 190 15 3 Technical standards on electromagnetic immunity 191 15 4 Configuration parameters 196 16 Annexes 199 16 1 Abbreviations...

Page 10: ...8 ...

Page 11: ...or safe and efficient use of your Accu Chek Spirit insulin pump Regardless of your experience with pump therapy please read this user guide carefully before using your Accu Chek Spirit insulin pump Always refer to this user guide for questions about operating and troubleshooting your Accu Chek Spirit insulin pump Roche Diagnostics is proud to work with you in the management of your diabetes therap...

Page 12: ...references in the form of tables and definitions 1 3 Working safely with your Accu Chek Spirit insulin pump Your Accu Chek Spirit insulin pump meets the safety requirements of your national medical device legislation and complies with or exceeds the international standards for Electromagnetic Compatibility regarding its use Section 1 4 introduces you to the intended use of the Accu Chek Spirit ins...

Page 13: ...details 1 4 Intended use of your Accu Chek Spirit insulin pump Your Accu Chek Spirit insulin pump is a prescription device and has been developed exclusively for the continuous subcutaneous delivery of U100 short acting insulin or fast acting insulin analogue The insulin type for the treatment of your insulin dependent diabetes mellitus will be prescribed by your doctor or healthcare team Do not u...

Page 14: ...12 ...

Page 15: ...nsure that they are correctly programmed into a new Accu Chek Spirit insulin pump Make sure that the time and date are set correctly If you are not sure about your personal settings or you are less experienced contact your doctor or healthcare team to check your personal settings Do not interrupt the start up procedure by pressing keys or by any handling on the insulin pump Interruption of the sta...

Page 16: ...te and program a new bolus if necessary If you do not set the correct battery type on your insulin pump the alert A2 BATTERY LOW may not occur in time to provide you sufficient warning to replace your battery If you flip the display orientation of your insulin pump by 180 the a and s keys will also reverse their functions In comparison to the display orientation the upper key will be a and the low...

Page 17: ...in pump with antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics They may contaminate these parts Avoid deliberate contact with water In case of deliberate contact with water disconnect and take off your insulin pump Check daily that your insulin pump and its sterile products are not chipped cracked or damaged in any way and that the battery cover and the ad...

Page 18: ... your insulin pump 2 1 3 Warnings and cautions on proper use Training and use of your insulin pump requires the support of an experienced doctor or healthcare team Regular visits with your doctor or healthcare team are absolutely essential during insulin pump therapy Change your personal settings only after consulting your doctor or healthcare team Always follow the instructions given by your doct...

Page 19: ... not able to feel the vibrations The display beeps and vibrations indicate critical alert information and must be addressed immediately by the insulin pump user Failure to see hear or feel the alerts from the insulin pump could result in serious harm or death of the user If insulin administration is interrupted for any reason e g stopping the pump by the user technical problem of the insulin pump ...

Page 20: ...perly tighten the infusion set to the adapter to avoid leakage Turn the infusion set luer lock connector only as far as to the stop Do not turn it any further and do not use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage Your insulin pump cannot detect infusion set leakage You must inspect all parts of your infusion set at least every three hours d...

Page 21: ...d lead to malfunction Programming your insulin pump for a relatively low basal rate 0 1 U h can result in a delayed error E4 OCCLUSION Roche Diagnostics recommends to use plastic cartridges when a low basal rate is required for your therapy Never prime an infusion set that is connected to your body You risk uncontrolled insulin delivery into your body With disconnectable infusion sets make sure yo...

Page 22: ...s out of reach of children 2 1 5 Warnings and cautions about environmental hazards Avoid electromagnetic fields of radar or antenna installations high voltage sources X Ray sources MRI CAT scan or other sources of electrical current Do not use your insulin pump in such areas Electromagnetic fields may cause malfunction to your insulin pump Always stop and remove your insulin pump prior to entering...

Page 23: ...your insulin pump in direct sunlight Overheating of the insulin and your insulin pump must be avoided Protect your insulin pump from direct exposure to cold wind In cold weather wear your insulin pump under your clothes or directly on your body Refer to the instructions for use of the insulin you are using for information on the admissible temperature range for the insulin 2 1 6 Warnings and cauti...

Page 24: ...anty They may leak and corrode the battery contacts within your insulin pump Always make sure that you remove the battery if your insulin pump is not in use for a longer time period in order to preserve the battery lifetime Old or used batteries may cause a failure at the insulin pump start up Change the battery only in a dry environment to prevent water from entering the casing and make sure that...

Page 25: ...g the day before you go to sleep and especially if for any reason you might be unable to hear the beeps or to feel the vibrations This is the only way you will be notified of any changes of your insulin pump in a suitable amount of time If the buttons on your pump are not functioning properly or you are unable to identify the buttons disconnect your insulin pump and contact your local Customer Car...

Page 26: ...24 ...

Page 27: ...formation Caution If you discover incomplete characters numbers or symbols on the display put your insulin pump into STOP and perform a system check by simply removing the battery for a few seconds Upon reinsertion of the battery the system check will occur If the incomplete characters numbers or symbols remain your insulin pump needs to be returned since you may not receive the correct informatio...

Page 28: ...r 20 seconds h if no further keys are pressed Note In areas of poor lighting turn the backlight on before you start programming 3 3 Keys and key combinations Your insulin pump s four keys are all you need to program the beeps vibration alerts and messages which appear on the display Caution Never press any of the keys with a sharp or pointed item such as the tip of your fingernail This could damag...

Page 29: ...screens f Check select a menu save changes and exit the function and information screen view the quick info screen a Up increase or decrease a setting s Down move forward or backward in the information screens program a Standard bolus cancel a Standard bolus turn off the STOP Warning press and hold a or s for 3 seconds until you hear a melody a Up turn on the backlight 27 The Accu Chek Spirit insu...

Page 30: ...s a s Press either key when two key symbols are unconnected to set a desired value a s You can program some sequence starting either with the a or s key For the recommended sequences press the key without parenthesis here the a key For the alternative sequence press the key in the parenthesis here the s key You will hear a beep each time a key is pressed unless the beep tone has been set to 0 Warn...

Page 31: ...If the KeyLock function is turned on it needs to be unlocked or turned off before any programming of your insulin pump can be performed All instructions in this user guide are given with the assumption that the KeyLock is NOT turned on To unlock the KeyLock press d s simultaneously you will hear three beeps in RUN or one beep in STOP and hold for 3 seconds until you hear again three beeps in RUN o...

Page 32: ...s value can be corrected by a single press of s or a if needed If activated your insulin pump will beep once when you start scrolling Key Beep Display Comment a A short initial beep Pressing the key By pressing the a or s identifies the results in a change the s key you can scrolling function of display information change a value Each press of the key will increase or decrease the value by one inc...

Page 33: ...formation Note If the beep volume is turned off your insulin pump will not beep when a key is pressed 3 7 Alarm signals Your insulin pump communicates the alerts and errors using beeps and vibrations You can turn off either the beeps or the vibrations but not both at the same time for the initial alarm signal Caution Check the display of your insulin pump at least every three hours during the day ...

Page 34: ... RUN screen See the sections 7 3 Start insulin delivery 7 7 3 Alarm signals and 16 4 Symbols for further information on the definition of these symbols Some functions must be programmed with your insulin pump in STOP during which insulin will not be delivered Your insulin pump must be in STOP to change the cartridge Always disconnect your pump from the infusion site and place the pump in STOP when...

Page 35: ...elody If you press a or s too a or s The STOP Warning briefly the STOP Warning for 3 seconds is turned off is not suppressed and occurs again The volume of the STOP Warning is independent of the programmed beep volume It always occurs at the maximum level The STOP Warning will be reactivated the next time your pump is changed from RUN into STOP or with the next battery change The operation of your...

Page 36: ...34 ...

Page 37: ...am and the instructions for use of the sterile products and accessories you are using Caution Only use sterile products and accessories that are designed for use with your insulin pump The proper functionality of your insulin pump can only be guaranteed in conjunction with Accu Chek sterile prod ucts and Accu Chek Spirit accessories All Accu Chek sterile products and accessories designed for the A...

Page 38: ... avoid infections Warning Your insulin pump and its sterile products and accessories include small component pieces that could pose a choking hazard to children Keep sterile products and accessories out of the reach of children Caution Always have extra sterile products and accessories with you This allows you to exchange components when needed Materials designed for single use such as cartridges ...

Page 39: ...5 2 1 Prepare the cartridge 5 3 1 Connect the cartridge adapter and infusion set and 5 7 Change the cartridge and infusion set for further information Warning Do not reuse single use materials Reuse of single use materials might lead to a malfunction of your insulin pump and to incorrect insulin delivery and or an infec tion Always handle the items with clean hands Use specified cartridges only Th...

Page 40: ...usion sets can be disconnectable non disconnectable Use only infusion sets with a luer lock connector All current Accu Chek infusion sets have luer lock connectors and are the preferred use for your Accu Chek Spirit insulin pump All Accu Chek infusion sets are PVC free They are made of materials which are skin friendly and neutral to insulin The diameter of the Accu Chek infusion set tubing has be...

Page 41: ...cally connects the cartridge and the infusion set It has two seals and forms an efficient seal against water ingress for the cartridge compartment of your insulin pump The two small vents on the adapter allow air pressure to equalize The adapter only works correctly when the vents are not plugged or dirty and when the seals are not worn out or missing The adapter should be replaced with at least e...

Page 42: ...argeable batteries if used in a typical usage pattern 50 U day operating temperature 22 C 3 C 72 F 6 F Note If you change from using regular batteries to rechargeable batteries or vice versa you must change the battery type in the SETUP MENU STANDARD See the section 7 7 5 Battery type for further information Caution Using AA batteries other than those supplied or recom mended by Roche Diagnostics ...

Page 43: ... temperature and other factors 4 4 Battery cover The battery cover forms an efficient seal for the battery compartment of your insulin pump The battery cover should be replaced with at least every 4th battery change Change the battery in a dry environment to prevent water from entering the casing Make sure that the seal is not worn out or missing and that the battery is properly inserted into your...

Page 44: ...ctors of the Accu Chek FlexLink and the Accu Chek TenderLink infusion sets Never use the battery key to attach or tighten an infusion set Caution Always make sure that you remove the battery if your insulin pump is not in use for a longer time period in order to preserve the battery lifetime To prevent water from entering the casing change the battery only in a dry environment and make sure that t...

Page 45: ...ew 3 15 ml plastic cartridge A pen or syringe for alternate therapy A vial of insulin Treatment for low blood glucose levels Blood glucose monitoring supplies such as an Accu Chek blood glucose monitor A disinfectant for skin A new site dressing The battery key The above list is only an example of what this emergency kit should contain Ask your doctor or healthcare team how to compose your persona...

Page 46: ...ransfer settings and information to and from their insulin pump Accu Chek Insulin Pump Configuration Software Pro for healthcare professionals is designed to allow healthcare professionals to program the insulin pump and to effectively manage patients insulin pump data Using Accu Chek Insulin Pump Configuration Software Pro for healthcare professionals allows healthcare professionals to program ad...

Page 47: ...t memory bolus and alarm history history of daily insulin totals and temporary basal rates are saved regardless of battery voltage and the time your insulin pump has been without a battery Keep the time date settings correct Always ensure that the time and date of your insulin pump are set correctly Incorrect programming of the time and date may cause incorrect insulin delivery If you or your heal...

Page 48: ...ent water from entering the casing change the battery only in a dry environment and make sure that the 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 battery key use of knives screwdrivers or other sharp objects may harm your insulin pump Do not over tighten as this may cause damage to the battery cover and to...

Page 49: ... the battery Insert the battery with cover with the flat negative end first into the battery compartment Carefully push the battery with cover in and turn the battery cover clockwise The battery cover is correctly inserted and tightened when the battery cover is even with the casing Do not over tighten Your insulin pump will now perform its start up procedure A melody signals the end of the start ...

Page 50: ...ll begin at the SELF TEST step Caution When you remove the battery your insulin pump remembers the settings you made and saved If your Accu Chek Spirit insulin pump remains without a battery for more than one hour check the time and date upon reinsertion of a battery Using AA batteries other than those supplied or recommended by Roche Diagnostics may significantly reduce the battery usage time Bat...

Page 51: ...ears SELF TEST appears Your insulin pump beeps and BEEP TEST appears Listen for the beeps Warning Do not interrupt the start up procedure by pressing keys or by any handling on the insulin pump Interruption of the start up procedure 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 i...

Page 52: ... display is completely black Caution If you cannot feel the vibrations your insulin pump needs to be returned since you may not be notified of any changes of your insulin pump in a suitable amount of time Contact your local Customer Care Area Caution If you cannot hear the beeps your insulin pump needs to be returned since you may not be notified of any changes of your insulin pump in a suitable a...

Page 53: ...nute with a long beep and a vibration to remind you that no insulin is delivered in STOP Press and hold s or a until you hear a melody to turn the STOP Warning off Note If the voltage of the inserted battery is too low the start up procedure cannot be performed completely Your insulin pump beeps a five tone and keeps restarting the start up procedure until you remove the battery or the battery is ...

Page 54: ...o the indicated expiration date Do not use sterile products if the package is damaged Do not reuse single use materials Reuse of 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 The use of other cartridges can endanger your health and may void the warran...

Page 55: ...ollowing items 1 3 15 ml plastic cartridge with protective cap plunger rod and filling needle 2 Instructions for use filling needle with protective cap cartridge cartridge protective cap plunger rod plunger 53 Prepare the pump for use ...

Page 56: ...ge have the following materials ready New 3 15 ml plastic cartridge with protective cap plunger rod and filling needle insulin at room temperature to minimize formation of air bubbles Wash your hands Set the insulin vial on a hard and flat surface like a table Clean the rubber membrane of the vial with an antiseptic wipe Remove the cartridge the cartridge protective cap and the filling needle with...

Page 57: ...tribute the lubricant Pull the plunger back to fill the cartridge with air Remove the protective cap from the needle Ensure that you do not touch anything with the needle Push the tip of the filling needle into the centre of the insulin vial s rubber membrane Push the plunger rod down so that all air from the cartridge enters the insulin vial 55 Prepare the pump for use ...

Page 58: ...he cartridge Do not pull or push the plunger rod while it is moving on its own this would cause the formation of air bubbles Slowly pull the plunger rod straight down to fill the cartridge Remove any air bubbles by tapping on the cartridge to dislodge them Push the air bubbles back into the insulin vial with the plunger rod The cartridge is completely filled when there are no air bubbles in the ca...

Page 59: ...et may cause the infusion of air instead of insulin Your body does not receive the required amount of insulin An error E4 OCCLUSION may be delayed Remove these 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...

Page 60: ...the proper position and twist the adapter until the cartridge plunger sits flush with the end plate of the piston rod When inserting an approved cartridge and adapter into the cartridge compartment twist the adapter clockwise until the adapter sits flush with the cartridge compartment In this position the cartridge plunger must also sit flush against the end plate of the piston rod This flush fit ...

Page 61: ... use only Sterility is guaranteed for unopened packaging up to the indicated expiration date Do not use sterile products if the packaging is damaged Do not reuse single use materials Reuse of 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 Avoid any contact of the infusion set and e...

Page 62: ... instructions 5 3 2 Insert the cartridge Should the piston rod not return completely contact your local Customer Care Area for support Caution Do not carry out the CHANGE THE CARTRIDGE function if the cartridge compartment is not completely dry During the rewinding of the piston rod liquid might enter your insulin pump and could lead to malfunction Caution To avoid leakage properly tighten the inf...

Page 63: ... pump is in STOP Press d to move to the CHANGE THE CARTRIDGE menu Select with f Remove the current cartridge if necessary Press and hold f for 3 seconds until you hear a melody Your insulin pump starts to return the piston rod remove the cartridge change the cartridge STOP screen returning piston rod cartridge volume 315 units start up procedure prime the infusion set 3 sec 61 Prepare the pump for...

Page 64: ...y on the display Position your insulin pump upright Insert the cartridge with attached adapter and infusion set into the cartridge compartment Twist do not push the adapter clockwise until it sits flush with the cartridge compartment It is not necessary to apply pressure as the twisting will properly position the cartridge The cartridge has been correctly inserted when the end plate of the piston ...

Page 65: ...he piston rod sits flush against the cartridge plunger When the cartridge has been inserted correctly press f Your insulin pump performs a self test See the section 5 2 Start Up procedure for further information 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 When the start u...

Page 66: ...fusion of air instead of insulin Your body will not receive the required amount of insulin An error E4 OCCLUSION may be delayed 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 these bubbles while filling the cartridge and priming the infusion set and without having the infusion set connected to your body Ensure ...

Page 67: ...ng process starts and a count up is shown on the display Your insulin pump automatically stops priming after 25 units h of insulin When the priming process is finished your insulin pump returns to STOP The infusion set is properly primed when no air bubbles are visible in the tubing anymore and a bubble free flow of insulin emerges from the tip of the needle start priming start up procedure stop p...

Page 68: ...ion site selection Your doctor or healthcare team will help you select your infusion site areas according to a planned infusion site rotation pattern You should avoid your waistline bones recent infusion sites bruises and sores Make sure to choose an infusion site at least 2 5 cm one inch away from the navel and previous infusion sites Infusion site preparation Proper infusion site preparation is ...

Page 69: ...Chek Spirit adapter and a new primed infusion set A disinfectant for skin Wash your hands thoroughly Desinfect the infusion site and let it dry completely Make sure your insulin pump is in STOP Insert your Accu Chek infusion set according to the corresponding instructions for use 67 Prepare the pump for use ...

Page 70: ...ing to the instructions for use of the infusion set you are using and your doctor s or healthcare team s recommendations Make sure your insulin pump is correctly equipped including cartridge adapter and infusion set and programmed with your personal settings approved by your doctor or healthcare team After you have carried out all steps required for the selection and prepara tion of the infusion s...

Page 71: ...not use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage Your insulin 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 Should you detect any loss of insulin and all parts are correctly tightened immedi ately replace the leaking component Immedi...

Page 72: ...luer lock connectors of the Accu Chek FlexLink and the Accu Chek TenderLink infusion sets You may use the battery key to loosen the luer lock connector between your infusion set and adapter if it cannot be loosened by hand Carefully prepare a new Accu Chek infusion set for use Turn the Accu Chek infusion set by hand clockwise into the adapter Properly tighten the luer lock connector by hand Prime ...

Page 73: ...nt for skin Make sure your insulin pump is in STOP Remove your infusion set from your infusion site Remove the infusion set from the adapter and dispose of it properly Note The battery key has a notch that fits the luer lock connectors of the Accu Chek FlexLink and the Accu Chek TenderLink infusion sets You may use the battery key to loosen the luer lock connector between your infusion set and ada...

Page 74: ... dispose of it properly d 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 e Clean the adapter with water and dry it if necessary If it shows signs of wear or dirt replace it immediately f Set up your insulin pump with a new cartridge and a new infusion set See the sections 5 2 1 Prepare the cartridge 5 3 Insert the cartr...

Page 75: ...our insulin pump on or underneath your clothes All specified accessories have been tested and approved for use with your Accu Chek Spirit insulin pump The proper functionality of your insulin pump can only be guaranteed in conjunction with Accu Chek Spirit accessories Consult our sterile products brochures and accessories catalogue for more information or contact your local Customer Care Area Caut...

Page 76: ...74 ...

Page 77: ...ns and STOP screen information screens This level is the home This level consists This level consists screen for your insulin of all available menus of all functions pump s operation Move through the menus You can get to all other to get to a specific functions from this level function or information When no keys are pressed your pump automatically returns to the 1st level 75 Select a user menu ST...

Page 78: ...r insulin pump saves the changes and returns to the RUN or STOP screen Note Flow Chart information printed in black is described in the instructions Gray printed information illustrates additional options Three dots indicates alternative ways to exit a menu Your insulin pump is equipped with advanced features to make programming even easier 1st level 2nd level 3rd level 1 2 3 4 5 menu looping exit...

Page 79: ...u to move backwards in the menu structure or to return to menus you just skipped Note Within a function and information screen 3rd level pressing d a simultaneously allows you to move up to the corresponding menu 2nd level without saving the current changes 6 2 4 Exit options At any function screen you have three options to exit if you want to confirm and save the changes press f Your insulin pump...

Page 80: ... the ADVANCED user menu ADVANCED user menu offers the full range of the Accu Chek Spirit functions The ADVANCED user menu includes all functions from the STANDARD user menu plus a wide range of additional functions for the more experienced user CUSTOM user menu because the Accu Chek Spirit has so many features you may want to selectively choose those features that you see when scrolling through th...

Page 81: ...nals can also turn on or off the following menus and functions PROGRAM BASAL RATE PROFILE 1 SELECT USER MENU See the Accu Chek Insulin Pump Configuration Software Pro for healthcare professionals user manual for further information on customizing your user menus Note When you change your user menu your current basal rate profile will not appear if it is not activated Make sure that your desired ba...

Page 82: ...d user menu Confirm with f The newly selected basal rate profile and its daily insulin total appear or if the previously turned on basal rate profile is not available from the newly selected user menu dashes appear instead Press a or s to select an available basal rate profile if necessary user menu select the user menu RUN screen select basal rate profile 80 Select a user menu STANDARD ADVANCED o...

Page 83: ...al Save and exit with f The new user menu and basal rate profile are active immediately Caution A running temporary basal rate increase or decrease will remain active even if you changed the basal rate profile 81 Select a user menu STANDARD ADVANCED or CUSTOM ...

Page 84: ...82 ...

Page 85: ...and date correctly because the basal rates and all history information are stored on the basis of time and date When travelling across time zones make sure that the time and date are set correctly The format can be either European or American American European 12 hour clock 24 hour clock month day year day month year See the sections 8 5 1 Time format and 8 5 2 Date format for further information ...

Page 86: ...ump s memory If you your doctor or healthcare team review your therapy data electronically it is essential that time and date of your insulin pump your blood glucose measure ment system such as an Accu Chek Blood Glucose Meter PC and other used devices are set identically If they are not the gathered data might not be meaningful Check regularly that the time and date of your insulin pump your bloo...

Page 87: ...th f Press a or s to set the hour Press d to move to the minutes Press a or s to set the minutes Press d to move to the year Press a or s to set the year set the hour set the time and date RUN screen set the minute set the year set the month set the day 85 STANDARD user menu ...

Page 88: ...firm and save the changes press f Your insulin pump returns to the RUN screen if you want to undo the changes wait for your insulin pump to return to the RUN screen timeout or press d a simultaneously exit feature to exit the current function screen Review the time and date The time is displayed on the RUN screen and STOP screen The date and time can be reviewed on the STOP screen 86 STANDARD user...

Page 89: ...total Your basal rate profile should be reviewed after any programming change performed with your insulin pump or the Accu Chek Insulin Pump Configuration Software after a new battery has been inserted and after confirming an error E7 ELECTRONIC ERROR Insulin delivery is not interrupted during basal rate programming Note The insulin amounts and other values used in this user guide are examples onl...

Page 90: ...ess d to move to the first hour The first hour which always begins at midnight 00 00 01 00 or 12 00 AM 01 00 AM if the American time format is used is shown Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team daily basal rate total program profile 1 RUN screen 1st hour 2nd hour 24th hour 88 STANDARD user menu ...

Page 91: ...E TOTAL Save and exit with f If the currently active basal rate profile is the same as the newly programmed basal rate it is active immediately Note At any screen you have three options to exit if you want to confirm and save the changes press f Check the new daily basal rate total Press f again Your insulin pump returns to the RUN screen if you want to undo the changes wait for your insulin pump ...

Page 92: ...ss a s simultaneously A special beep confirms that you are pressing the keys correctly The same hourly basal rate is copied to the next hour or hours if you press a s repeatedly Press and hold a s scroll to copy the same hourly basal rate for multiple hours Confirm with f Check the new daily BASAL RATE TOTAL Save and exit with f If the currently active basal rate profile is the same as the newly p...

Page 93: ...e body If insulin administration is interrupted for any reason e g stopping the insulin pump by the user technical problem with the insulin pump leakage in the cartridge occlusion of the infusion set tube or of the infusion set needle infusion set needle has slipped out of the infusion site you must be prepared to replace the missing insulin immediately Always carry spare sterile products and acce...

Page 94: ... pump shows the RUN screen Insulin delivery begins within the next 3 minutes at the hourly basal rate shown on the display Note Check the amount of insulin remaining in the cartridge at least once a day Before going to sleep make sure that the cartridge contains enough insulin to last through the night the time and date are set correctly start your ACCU CHEK STOP screen RUN screen 92 STANDARD user...

Page 95: ...d vice versa using Accu Chek Insulin Pump Configuration Software Press d to move to the STOP YOUR ACCU CHEK menu Confirm with f Your insulin pump returns to the STOP screen and insulin delivery stops Press f from the RUN screen or STOP screen quick info screen to check for symbols of activated functions and features like the beep and vibration alarm signals Caution When your insulin pump is in STO...

Page 96: ...ou hear a melody The STOP Warning is turned off Note The volume of the STOP Warning is independent of the programmed beep volume It always occurs at the maximum level The STOP Warning will be reactivated the next time your pump is changed from RUN to STOP or with the next battery change STOP Warning The STOP Warning is turned on each time your insulin pump is put from RUN into STOP or when a batte...

Page 97: ... time MultiWave bolus combines fast delivery with delivery over a programmed period of time For instructions on how to program an Extended bolus and a MultiWave bolus please refer to section 8 ADVANCED user menu Warning Incorrect programming of your insulin pump may cause inappropriate insulin delivery Your insulin pump must be programmed with your personal settings prior to starting insulin pump ...

Page 98: ...programming of the amount The bolus amount per delivery is limited to 25 units h of insulin Programming a Standard bolus includes a short start delay of 5 seconds before the actual bolus delivery If necessary this allows you to cancel the bolus before the bolus delivery has started by the press of the a or s key Alert A8 BOLUS CANCELLED will occur Press f twice to confirm and turn off the alert Se...

Page 99: ...ou through the programming you may program the Quick bolus with one finger Once the bolus is programmed you can count the beeps and vibrations of your insulin pump to verify the correct programming The bolus increment for the Quick Standard bolus is initially set to 0 5 units h It can be changed in the SETUP MENU ADVANCED or by using Accu Chek Insulin Pump Configuration Software From the RUN scree...

Page 100: ...s the total bolus amount with one simultaneous beep and vibration for each bolus increment programmed For 5 seconds h bolus delivery start delay the Standard bolus symbol blinks After this bolus delivery start delay your insulin pump beeps three times and starts to deliver the total bolus amount programmed The countdown of the remaining bolus amount appears on the display Warning The bolus increme...

Page 101: ...f twice to confirm and turn off the alert See the section 10 1 8 Alert A8 BOLUS CANCELLED for further information No bolus is delivered During bolus delivery countdown of bolus amount Press and hold the s or a key for 3 seconds until you hear a melody An alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert See the section 10 1 8 Alert A8 BOLUS CANCELLED for further infor...

Page 102: ...e to the STANDARD BOLUS menu Select with f The BOLUS AMOUNT screen appears Press or scroll a to increase or s to decrease the bolus amount Press f to confirm the bolus amount During 5 seconds h bolus delivery start delay the Standard bolus symbol blinks After this bolus delivery start delay your insulin pump beeps three times and starts to deliver the total bolus amount programmed The countdown of...

Page 103: ...onfirm and turn off the alert No bolus is delivered Please refer to section 10 1 8 Alert A8 BOLUS CANCELLED for further information During bolus delivery countdown of bolus amount Press and hold the s or a key for 3 seconds until you hear a melody An alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert Bolus delivery is interrupted Please refer to section 10 1 8 Alert A8...

Page 104: ... than 0 With a temporary basal rate of 0 no insulin except boluses is delivered during the programmed duration Discuss programming a temporary basal rate with your doctor or healthcare team Note A running temporary basal rate increase or decrease remains active even if you change the basal rate profile Warning Incorrect programming of your insulin pump may cause inappropriate insulin delivery Your...

Page 105: ... the percentage is set to 100 If a temporary basal rate is active its duration and percentage appear on the RUN screen Press a to increase or s to decrease the basal rate Note When you increase or decrease the temporary basal rate the duration of your previous temporary basal rate increase or decrease appears automatically or when using your insulin pump for the first time a default value appears ...

Page 106: ...en timeout or press d a simultaneously exit feature to exit the current function screen set precentage to 100 and press f Note During the TBR delivery the increase or decrease in percent age the increased or decreased hourly basal rate hourly basal rate plus minus TBR percentage and the remaining time are displayed in the RUN screen An arrow pointing up symbolizes a temporary basal rate increase a...

Page 107: ...key for 20 seconds h your insulin pump returns to the RUN screen timeout Exit to the TEMPORARY BASAL RATE TBR menu by pressing d a simultaneously Set the TBR percentage to 100 Save and exit with f No temporary basal rate is active During delivery You have two options for cancelling a temporary basal rate during delivery Set the TBR percentage to 100 Press d to move to the TEMPORARY BASAL RATE TBR ...

Page 108: ... CANCELLED occur Press f twice to confirm and turn off the first alert Then the second alert appears on the display Press f twice to confirm and turn off the second alert Both alerts are recorded in the alarm history See the sections 10 1 6 Alert A6 TBR CANCELLED and 10 1 8 Alert A8 BOLUS CANCELLED for further information Ensure that the cancellation was intended and program a new temporary basal ...

Page 109: ...allows you to lock the four keys of your insulin pump and serves as an additional safety measure against unintentional activation of functions e g while sleeping during contact sports To make use of the KeyLock function it must be turned on See the section 3 3 Keys and key combinations for further information Warning Incorrect programming of your insulin pump may cause inappropriate insulin delive...

Page 110: ...ress a or s to turn the KeyLock ON or OFF Save and exit with f If no further key is pressed for 10 seconds h after your insulin pump has returned to the RUN screen or STOP screen all four keys are automatically locked if the KeyLock is turned on Note The only function which can still be activated is the backlight press a setup standard RUN STOP screen KeyLock beep volume alarm signals automatic of...

Page 111: ... is pressed for 10 seconds h after your insulin pump has returned to the RUN screen or STOP screen all four keys are automatically locked 7 7 2 Adjust the beep volume Your insulin pump beeps when a key is pressed or when an alert or error occurs The volume of these beeps can be changed Press d to move to the SETUP MENU STANDARD Select with f Press d to move to the BEEP VOLUME screen The active bee...

Page 112: ...ps are turned off and an alert or error occurs the beeps will become activated after a short period of time to ensure that you are aware of the alarm or error These beeps will steadily increase in volume until the maximum level occurs if the alert or error is not cancelled 7 7 3 Alarm signals The Accu Chek Spirit allows you to choose how you want your pump to alert you when an alarm occurs You hav...

Page 113: ...set to OFF or programmed up to 24 hours in 1 hour intervals in the SETUP MENU STANDARD Press d to move to the SETUP MENU STANDARD Select with f Press d to move to the AUTOMATIC OFF screen The active status is displayed Press or scroll a to increase or s to decrease the duration for the automatic off in 1 hour intervals If you would like to set the auto matic off function to OFF press or scroll s u...

Page 114: ...her information on recommended batteries Press d to move to the SETUP MENU STANDARD Select with f Press d to move to the BATTERY TYPE screen The current battery type is displayed Press a or s to select the desired battery type ALKALINE or NiMH rechargeable battery Save and exit with f Warning If you do not set the correct battery type on your insulin pump the alert A2 BATTERY LOW may not occur in ...

Page 115: ...to select the desired display orientation Save and exit with f Caution If you flip the display orientation of your insulin pump by 180 the a and s keys will also reverse their functions In comparison to the display orientation the upper key will be the a and the lower key will be s This change applies for all a and s functions including turning on the backlight The d and f keys will not change in ...

Page 116: ...rrors History of daily insulin totals last 30 daily totals of insulin delivered Temporary basal rate history last 30 increases and decreases Pump Timer remaining time in days until the pump timer expires Quick info screen remaining cartridge content 7 8 1 Review the bolus history The bolus history enables review of up to the last 30 bolus deliveries starting with the most recent entry in chronolog...

Page 117: ... with f The BOLUS HISTORY screen appears The most recent bolus information is displayed Press a or s to review the entries Exit with f information menu RUN screen alarm history daily total TBR history pump timer bolus history 115 STANDARD user menu ...

Page 118: ... to the INFORMATION menu Select with f Press d to move to the ALARM HISTORY screen Press a or s to review the entries Exit with f 7 8 3 Review the daily insulin totals history This history enables you to review the last 30 daily totals of insulin delivered from midnight to midnight basal rate plus bolus deliveries starting with the most recent entry in chronological order Each daily insulin total ...

Page 119: ...creases or decreases starting with the most recent entry in chronological order Each TBR history screen displays the TBR increase or decrease in percentage TBR duration time when TBR was over date and entry number 01 is the most recent of total entries e g 01 30 of a delivered temporary basal rate Press d to move to the INFORMATION menu Select with f Press d to move to the TBR HISTORY screen Press...

Page 120: ...ing time so that you can make the necessary arrangements The pump timer symbol appears in the RUN screen or STOP screen as a reminder When the timer expires an error occurs and your insulin pump goes into STOP It can no longer be put into RUN See the sections 10 1 5 Alert A5 PUMP TIMER and 10 2 5 Error E5 END OF OPERATION for further information The time remaining in days until the pump timer expi...

Page 121: ...ts and the insulin concentration Symbols for activated functions and features like the beep and vibration alarm signals are displayed To get to the quick info screen Press f from the RUN screen or STOP screen After 8 seconds h your insulin pump automatically returns to the RUN screen or STOP screen 119 STANDARD user menu ...

Page 122: ...120 ...

Page 123: ...ctions individually choose the SELECT USER MENU function select the CUSTOM user menu and turn the individual features on or off as desired using Accu Chek Insulin Pump Configuration Software As was done with the STANDARD user menu settings on the Accu Chek Spirit you can save or exit your programming using the same three simple methods For all of the features in this section you may do the followi...

Page 124: ...confirmation Note You can add a Standard bolus to an ongoing Extended bolus If you cancel the Standard bolus the Extended bolus remains running 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 your insulin pump into STOP to cancel the current bolus and program a new one Warning I...

Page 125: ...ars or when using your insulin pump for the first time a default value appears Press d to move to the BOLUS DURATION Press a to increase or s decrease the bolus duration Note Press d to loop between programming the bolus amount and bolus duration if necessary Check the bolus amount and duration programmed on the display bolus amount Extended bolus RUN screen bolus duration stop your ACCU CHEK A8 b...

Page 126: ...ining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen 8 1 2 Cancel an Extended bolus During programming the bolus amount or bolus duration blinks You have three options for cancelling an Extended bolus during programming If you do not press any key for 20 seconds h your insulin pump returns to the RUN screen timeout Exit t...

Page 127: ...te is active at the same time it is also cancelled when your insulin pump is put into STOP An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press f twice to confirm and turn off the first alert Then the second alert appears on the display Press f twice to confirm and turn off the second alert Both alerts are recorded in the alarm history See the sections 10 1 6 Alert A6 TBR CANCELLE...

Page 128: ...th both rapid and slowly absorbed carbohydrates e g pizza The duration of bolus delivery can be programmed in 15 minute h intervals up to 12 hours h and begins immediatly after confirmation Note You can add a Standard bolus to an ongoing MultiWave bolus If you cancel the Standard bolus the MultiWave bolus remains running During the delivery of a MultiWave bolus the programming of another MultiWave...

Page 129: ... duration of the last MultiWave bolus appears or when using your insulin pump for the first time a default value appears In addition as you increase or decrease the total bolus amount the suggested immediate bolus amount increases or decreases proportionally bolus delivery bolus amount MultiWave bolus RUN screen immediate bolus bolus duration 5 sec delay A8 bolus cancelled 3 sec or stop your Accu ...

Page 130: ...xtended bolus duration if necessary Check the total and immediate bolus amounts and the Extended bolus duration programmed on the display The set values can be viewed in the total bolus amount immediate bolus and bolus duration screen Press f to confirm both bolus amounts and the bolus duration For 5 seconds h bolus delivery start delay the MultiWave bolus symbol blinks Your insulin pump beeps thr...

Page 131: ...ur insulin pump returns to the RUN screen timeout Exit to the MULTIWAVE BOLUS menu by pressing d a simultaneously Set the total bolus amount to 0 0 units and press f No bolus is delivered During the start delay blinks Press s or a Your Accu Chek Spirit beeps and vibrates Your insulin pump returns to the RUN screen An alert A8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert S...

Page 132: ...See the section 7 8 1 Review the bolus history for further information Note If a temporary basal rate is active at the same time it is also cancelled when your insulin pump is put into STOP An alert A8 BOLUS CANCELLED and an alert A6 TBR CANCELLED occur Press f twice to confirm and turn off the first alert Then the second alert appears on the display Press f twice to confirm and turn off the secon...

Page 133: ...lthcare team decide that additional basal rate profiles are not necessary you may hide basal rate profiles 2 to 5 in the CUSTOM user menu using Accu Chek Insulin Pump Configuration Software Pro for healthcare professionals see the Accu Chek Insulin Pump Configuration Software user manual for additional information 8 3 1 Set an additional basal rate profile 1 Make sure the PROGRAM BASAL RATE PROFIL...

Page 134: ...rate profile is displayed Note Only basal rate profiles that are accessible in your current user menu are available Press a or s to select the desired basal rate profile The newly selected basal rate profile and its basal rate total appear Save and exit with f The new basal rate profile is active immediately BR profile no change the BR profile RUN screen 132 ADVANCED user menu ...

Page 135: ...or program the desired basal rate profile to an available basal rate profile number A running temporary basal rate increase or decrease remains active even if you change the basal rate profile on your pump 8 4 Alarm clock The alarm clock can be set for a single alarm and for multiple alarms Multiple alarms are repeated every day These alarms may be utilized to remind you of blood glucose testing o...

Page 136: ...nute Save and exit with f To turn off the alarm clock When the alarm clock goes off an alert A4 ALARM CLOCK occurs Press f twice to confirm and turn off the alert See the section 10 1 4 Alert A4 ALARM CLOCK for further information 8 5 Setup menu advanced 8 5 1 Time format The time can be set in the following formats European 24 hour clock 00 00 23 59 e g 13 39 American 12 hour clock AM PM e g 1 39...

Page 137: ... Save and exit with f 8 5 2 Date format The date can be set in the following formats European dd mm yy e g 26 04 06 American mm dd yy e g 04 26 06 Make sure the SETUP MENU ADVANCED is turned on Press d to move to the SETUP MENU ADVANCED Select with f Press d to move to the DATE FORMAT screen Press a or s to select the desired date format Save and exit with f 135 ADVANCED user menu ...

Page 138: ...olding down the a or s keys will move at a constant 0 1 units See the section 7 5 1 Standard bolus for further information Make sure the SETUP MENU ADVANCED is turned on Press d to move to the SETUP MENU ADVANCED Select with f Press d to move to the BOLUS INCREMENT screen Press a or s to select the desired bolus increment Save and exit with f Warning The bolus increment that can be programmed into...

Page 139: ...for the prime quantity is 25 h units of 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 insulin pump s keys to stop priming Make sure the SETUP MENU ADVANCED is turned on Press d to move to the SETUP MENU ADVANCED Select with f Press d to move to the PRIME QUANTITY screen Press a or s to select the desired prime ...

Page 140: ...with f Press d to move to the BASAL RATE LOCK screen Press a or s to turn the basal rate lock ON or OFF Save and exit with f Note If the basal rate lock is set to ON the programing of the basal rate profiles 1 2 3 4 and 5 is blocked To check if the basal rate lock is ON move with d to a PROGRAM BASAL RATE menu and select with f The symbol in the BASAL RATE TOTAL screen indicates the lock of the ba...

Page 141: ...se the language of your choice do the following Make sure the SETUP MENU ADVANCED is turned on Press d to move to SETUP MENU ADVANCED Select with f Press d to move to the LANGUAGE screen Press a or s to select the desired language Save and exit with f 139 ADVANCED user menu ...

Page 142: ...t the display contrast Make sure the SETUP MENU ADVANCED is turned on Press d to move to the SETUP MENU ADVANCED Select with f Press d to move to the DISPLAY CONTRAST screen Press a or s to select the desired contrast Save and exit with f 140 ADVANCED user menu ...

Page 143: ...d adapter which is connected to your PC s RS232 serial interface Refer to the user manuals of the corresponding Accu Chek information management products for detailed infrared adapter information and for further instructions on the data transfer feature Caution If data transfer between your PC and your insulin pump is disrupted in any way the configuration may be incomplete and an error E12 DATA I...

Page 144: ...d to move to the COMMUNICATION menu Select with f The DATA TRANSFER screen appears and a melody signals that your insulin pump is ready to receive data from or deliver data to your PC Follow the instructions in the Accu Chek Insulin Pump Configuration Software user manual When the data transfer is finished press f to return to STOP communi cation STOP screen start data transfer stop data transfer ...

Page 145: ...cessary Note Your insulin pump automatically returns to STOP 15 minutes h after the last data transfer respectively when the DATA TRANSFER screen has been selected You may press d a simultaneously to exit while data is being transferred The data transfer is interrupted and an error E12 DATA INTERRUPTED occurs See section 10 2 11 Error E12 DATA INTERRUPTED for further information 143 Data transfer ...

Page 146: ...144 ...

Page 147: ...is the only way you will be notified of any changes of your insulin pump in a suitable amount of time In general alerts and errors are signalled by both beeps and vibrations If you have turned off either the beeps or vibrations only the turned on alarm signal goes off when the alert or error occurs for the first time If you do not confirm the alert or error within 60 seconds it occurs again with b...

Page 148: ...ch alert or error to turn off and confirm When you confirm A1 CARTRIDGE LOW E1 CARTRIDGE EMPTY A2 BATTERY LOW E2 BATTERY DEPLETED A5 PUMP TIMER or E5 END OF OPERATION the symbol for that alert and error stays in the RUN screen or STOP screen as a reminder For the other alerts and errors the alarm information is cleared from the display and remains only in the alarm history and the event memory Aft...

Page 149: ...N or STOP screens as a reminder until you change the cartridge Press f twice to turn off and confirm the alert Change the cartridge before it is empty Put your insulin pump into RUN if necessary Warning After the occurrence of an alert your insulin pump may be in STOP and the insulin delivery may be interrupted In order to maintain insulin delivery you must act immediately according to the instruc...

Page 150: ...off and confirm the alert Replace the battery within the next hours Put your insulin pump into RUN if necessary 10 1 3 Alert A3 REVIEW TIME AND DATE If the battery is removed for more than 1 hour it may be necessary to enter the time and date again Other Accu Chek Spirit settings and the event memory are not affected and are preserved regardless of battery voltage and time your insulin pump has be...

Page 151: ... a pump timer To inspect the pre set lifetime of your Accu Chek Spirit pump before you start using it please refer to the Accu Chek Spirit Pump Protocol included in the starter kit During use the remaining lifetime in days until the expiration date of your insulin pump can be reviewed in the INFORMATION menu see Review the time remaining To ensure you are aware of this timing feature the alert A5 ...

Page 152: ...nsulin pump Note The alert A5 PUMP TIMER and the error E5 END OF OPERATION are based on running time period with pump in RUN and not calendar years Your actual warranty is based upon the date the pump was first purchased 10 1 6 Alert A6 TBR CANCELLED Temporary Basal Rate cancelled An alert A6 TBR CANCELLED occurs when a temporary increase or decrease of the basal rate has been cancelled The origin...

Page 153: ...ned off using Accu Chek Insulin Pump Configuration Software If turned off the alert does not occur when a temporary basal rate ends 10 1 8 Alert A8 BOLUS CANCELLED If a bolus is cancelled during the start delay or after delivery has begun an alert A8 BOLUS CANCELLED occurs Press f twice to turn off and confirm the alert Put your insulin pump into RUN if necessary Ensure that the cancellation was i...

Page 154: ...site Change the cartridge and prime the new infusion set Reconnect the infusion set tubing at your infusion site or insert the new infusion set When finished put your insulin pump into RUN Warning After the occurrence of an error your insulin pump will be in STOP and the insulin delivery is interrupted In order to maintain insulin delivery you must act immediately according to the instructions giv...

Page 155: ...Error E3 AUTOMATIC OFF This safety function interrupts insulin delivery if no keys are pressed within a certain period of time Refer to section 7 7 4 Automatic off for more information Press f twice to turn off and confirm the error Put your insulin pump into RUN Warning After inserting a new battery always ensure that the time and date of your insulin pump are set correctly Incorrect programming ...

Page 156: ...luses For example a blocked infusion set with a basal rate of 2 0 U h no additional boluses would have an error E4 OCCLUSION in approximately three hours or less using Accu Chek 3 15 ml plastic cartridges depending on the type and severity of the blockage Warning If an error E4 OCCLUSION occurs immediately check your blood glucose level because insulin delivery has been interrupted If your blood g...

Page 157: ...the infusion set tubing Change the infusion set tubing Prime the new infusion set tubing and connect it to your infusion site Put you insulin pump into RUN If however still an error E4 OCCLUSION occurs the cartridge can be the cause of the occlusion Remove the cartridge and activate the PRIMING function without cartridge and without attached adapter and infusion set If no error E4 OCCLUSION occurs...

Page 158: ...mp into RUN If however still an error E4 OCCLUSION occurs the cartridge can be the cause of the occlusion Remove the cartridge and activate the PRIMING function without cartridge and without attached adapter and infusion set If no error E4 OCCLUSION occurs the occlusion was within the cartridge Activate the CHANGE THE CARTRIDGE function Insert a new filled cartridge with attached adapter and a new...

Page 159: ...imized your pump features a pump timer To inspect the pre set lifetime of your Accu Chek Spirit pump before you start using it please refer to the Accu Chek Spirit Pump Protocol included in the starter kit During use the remaining lifetime in days until the expiration date of your insulin pump can be reviewed in the INFORMATION menu see Review the time remaining Contact your local HelpDesk to disc...

Page 160: ...e cartridge adapter infusion set tubing and battery from your insulin pump Insert a new battery Rewind the piston rod Start the CHANGE THE CARTRIDGE function When the cartridge volume is displayed press or scroll a or s to move the plunger rod forward until it reaches the remaining cartridge content which was noted down Set up your insulin pump with the cartridge and a new infusion set Prime the i...

Page 161: ... disconnect the infusion set from your infusion site Insert a new battery into the pump Prime the infusion set Reconnect the infusion set tubing at your infusion site or insert the new infusion set When finished put your insulin pump into RUN 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 cont...

Page 162: ...oes into STOP Check the time and date and correct if necessary 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 When finished put your insulin pump into RUN if necessary If necessary program a new bolus and or temporary basal rate If an error E8 POWER INTERRUPT occurs during programm...

Page 163: ... set from your infusion site Remove the cartridge Start the CHANGE THE CARTRIDGE menu Reinsert the cartridge Prime the infusion set Reconnect the infusion set tubing at your infusion site or insert the new infusion set When finished put your insulin pump into RUN If an error E10 CARTRIDGE ERROR occurs during the winding of the piston rod insert a new battery into the pump and repeat the steps abov...

Page 164: ...the infusion set from your infusion site Prime the infusion set Reconnect the infusion set tubing at your infusion site or insert the new infusion set When finished put your insulin pump into RUN Warning Never prime an infusion set that is connected to your body You risk uncontrolled insulin delivery into your body With disconnectable infusion sets make sure you have disconnected the tubing from y...

Page 165: ...fer must be successfully concluded Refer to the Accu Chek Insulin Pump Configuration Software user manual for further instructions on using the data transfer feature Press f twice to turn off and confirm the error Restart the data transfer Caution If data transfer between your PC and your insulin pump is disrupted in any way the configuration may be incomplete and an error E12 DATA INTERRUPTED occ...

Page 166: ...an error E13 LANGUAGE ERROR occurs check the language and reset if necessary Press f twice to turn off and confirm the error Refer to the ADVANCED SETUP MENU for instructions on how to change the language When finished put your insulin pump into RUN if necessary ...

Page 167: ...t 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 with your insulin pump therapy Be aware that the interruption of insulin delivery e g due to a leak occlusion or loss of insulin potency or the malfunc tion of your insulin pump can result in a rapid rise of your blood glucose level Although your i...

Page 168: ...e contact your local Customer Care Area Remove the battery insert it again after a few seconds If the self test remains incomplete contact your local Customer Care Area The correct hourly basal rate cannot be delivered if the time is not set correctly Check and reset the time as necessary Do the same check when changing the battery Always review any changes made in basal rate programming Confirm t...

Page 169: ...curity Inspect connections for leaking insulin Check your blood glucose level Change your infusion set and infusion site 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 Disconnect and re prime your infusion set If the occlusion remains carry out the PRIME THE INFUSION SET function without the c...

Page 170: ...se levels Contact your doctor or healthcare team for recommendations on how to manage these or any other therapy related issues Problem Infusion site becomes sore red or swollen Recommended Actions Change your infusion set and infusion site immediately Use proper insertion technique and always follow the planned infusion site rotation pattern and advice given by your doctor or healthcare team 168 ...

Page 171: ...on site When using a disconnectable infusion set disconnect at your infusion site and use the protective covers provided for the infusion set 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 Caution Training and use of your insulin pump require the support of an ...

Page 172: ...s check your personal settings in order to avoid incorrect insulin delivery Make sure that the time and date are set correctly There may be times when you may interrupt your insulin pump therapy for more than 1 day To interrupt the use of your insulin pump 1 Put your insulin pump into STOP 2 Remove the cartridge adapter and infusion set 3 Reinsert the adapter 4 Remove the battery and reinsert the ...

Page 173: ...rating conditions Caution Do not place your insulin pump in direct sunlight Overheating of the insulin and your insulin pump must be avoided Protect your insulin pump from direct exposure to cold wind Temperatures over 40 C 104 F and below 5 C 41 F may damage the insulin and the electronics of your insulin pump and may cause a malfunction of the battery See the instructions for use of the insulin ...

Page 174: ...convenience we recommend to use disconnectable Accu Chek infusion sets Consult your doctor or healthcare team for the length of time insulin pump therapy can safely be interrupted Caution Avoid deliberate contact with water Check daily that your insulin pump is not chipped cracked or damaged in any way and that the battery cover and the adapter are correctly closed In the presence of chips and cra...

Page 175: ...our insulin pump Check the battery compartment and the cartridge compartment for any water ingress Should the battery compartment or cartridge compart ment get wet turn your insulin pump upside down to let the water run out and let it dry Do not use warm air e g a hair dryer to dry as this could damage the internal electronics of your insulin pump Do not insert the battery or the cartridge before ...

Page 176: ...lutions alcohol beverages See the section 14 2 1 Cleaning your Accu Chek Spirit insulin pump for further information Caution Avoid any contact of your insulin pump the infusion set and the connecting parts of your insulin pump with health and beauty items e g antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics 174 Life with your Accu Chek Spirit insulin pump...

Page 177: ...sted and found to comply with the regulations concerning unintentional electromagnetic interference Security systems for transit checks in airports as well as anti theft monitoring devices e g department stores etc should not affect the functionality of your insulin pump Because of the high variety of devices with electromagnetic radiation such as cellular phones their influence on your insulin pu...

Page 178: ...ek Spirit insulin pump However prior to starting these types of activities be sure to protect your insulin pump Do not wear your insulin pump during sports with body contact e g boxing football hockey or rugby as this type of activity could damage your insulin pump Consult our sterile products brochures and accessories catalogue for additional information regarding carrying systems or contact your...

Page 179: ...least every three hours during the day before you go to sleep and especially if for any reason you might be unable to hear the beeps or to feel the vibrations Use only sterile products and accessories designed for use with your insulin pump Replace and discard these items according to your doctor s or healthcare team s recommendations and according to the specifications in the corresponding instru...

Page 180: ...s correctly tightened even with the pump casing The adapter is inserted properly and correctly tightened Your infusion set is primed free of air bubbles and tight in the adapter Your infusion set is inserted according to the corresponding instructions for use Your infusion site is secure comfortable and free of irritation or infection The cartridge is free of air bubbles Your insulin pump is in RU...

Page 181: ...mmended by Roche Diagnostics or NiMH rechargeable batteries with a minimum capacity of 1500 mAh Caution To prevent water from entering the pump casing change the battery only in a dry environment and make sure that the seal of the battery cover is not worn out or missing and that the battery is properly inserted Caution Always remove the cartridge and adapter and place your insulin pump in STOP wh...

Page 182: ...mp Do not over tighten as this may cause damage to the battery cover and to the pump casing The battery cover is correctly inserted and tightened when the battery cover is even with the pump casing The battery life is approximately four weeks for alkaline batteries and one week for rechargeable batteries if used in a typical usage pattern 50 U day using U100 insulin operating temperature 22 C 3 C ...

Page 183: ...nt dropping If your insulin pump is dropped Check that all connections regarding your infusion set are still tight and reconnect if necessary Check your insulin pump its sterile products and accessories for chips and cracks AND Change the cartridge if necessary In case of doubt contact your local Customer Care Area Caution Check your insulin pump and its sterile products and accessories for chips ...

Page 184: ...ation Place your insulin 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 insulin pump with a carrier that tracks the shipment Remember to include a note with a description of the reason for returning your insulin pump your name and address your daytime phone the serial number of your insulin pump AND any RMA Return Material Authorizati...

Page 185: ...rofessional disposal Battery Dispose of depleted batteries at your nearest battery disposal center Cartridge infusion set adapter and additional accessories Dispose of these items in your normal garbage 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 into a hard shell container ...

Page 186: ...184 ...

Page 187: ...ox 110 g 4 0 ounces Shock and scratch resistant plastic resistant to pharmaceuticals all edges rounded During operation 5 to 40 C 41 to 104 F Storage in its 5 to 45 C shipping case 41 to 113 F During operation 20 to 90 rel Storage in its shipping case 5 to 85 rel During operation 70 to 106 kPA or storage in its 700 to 1060 mbar shipping case do not exeed 3000 meters 10000 feet above sea level See ...

Page 188: ...attery life is approxi mately four weeks for alkaline batteries and one week for rechargeable batteries 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 ...

Page 189: ...5 minutes up to 12 hours Adjustable in 10 increments 0 90 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 Plastic cartridges at med basal rate 1 0 U h 5 h at min basal rate 0 1 U h 50 h The typical time for an error was 3 5 hours Ave...

Page 190: ...set priming and bolus 0 2 U sec 1 0 U Accu Chek 3 15 ml plastic cartridges with a luer connection and by Roche Diagnostics approved third party products Aventis Insuman Infusat cartridges have been evaluated and approved for use with the Accu Chek Spirit insulin pump Accu Chek infusion sets with a luer lock connector Accu Chek Infusion sets are PCV and latex free Infrared interface Technical data ...

Page 191: ... 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 motor also constitutes an important safety component as the combination of the main and supervisor processor and brushless motor provides the best possible reliability and accuracy in insulin delivery P...

Page 192: ...issions Group 1 The Accu Chek Spirit uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interfer ence in nearby electronic equipment RF emissions Class B The Accu Chek Spirit is suitable for use in all CISPR 11 establishments including domestic establish ments and those directly connected to the public low voltage power su...

Page 193: ... Accu Chek Spirit is intended for use in the electromagnetic environment specified below The customer or the user of the Accu Chek Spirit should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Power frequency 50 60Hz magnetic field IEC 61000 4 8 Guidance and manufacturer s declaration electromagnetic immunity The Accu Chek Spirit is intended fo...

Page 194: ...smitter Recommended separation distance where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in th...

Page 195: ...idered If the measured field strength in the location in which the Accu Chek Spirit is used exceeds the applica ble RF compliance level above the Accu Chek Spirit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorient ing or relocating the Accu Chek Spirit b Over the frequency range 150 kHz to 80 MHz field strengths s...

Page 196: ...e stabilization period The trumpet curve shows the accuracy of the delivery rate in relation to the observation period The maximum deviation of the delivered amount overall mean percentage flow error for U100 insulin is 5 194 Technical data Insuman Infusat produced by Aventis Pharma Deutschland GmbH a member and a brand of the sanofi aventis group ...

Page 197: ... insulin pump is located 1 m 3 3 feet above below the infusion site Bolus For U100 insulin the maximum deviation of a maximum bolus is 5 and the maximum deviation of a minimum bolus is 30 195 Technical data The measurements were made at a medium basal rate of 1 0 U h according to IEC 60601 2 24 1998 with a Disetronic Classic infusion set PC 16 110 at room temperature The measurements were made acc...

Page 198: ...e Accu Chek Insulin Pump Configuration Software Always consult your doctor or healthcare team before changing parameters The Accu Chek Spirit allows you to customize your user menus If a menu does not appear see the section 6 Select a user menu STANDARD ADVANCED or CUSTOM and the Accu Chek Insulin Pump Configuration Software user manual for further information on addressing all menus on your insul...

Page 199: ...he pump and standard parameter settings 20 0 IU h 0 1 IU 10 0 IU h 0 200 10 15 min 24 h 15 min 1 5 on or off presetting off 25 0 IU 0 1 0 2 0 5 1 0 or 2 0 IU presetting 0 5 IU 15 min 12 h 15 min 0 30 0 IU presetting 25 IU Maximum parameter range adjustable with the Accu Chek Insulin Pump Configuration Software max amount 0 62 50 IU h max amount 0 25 0 IU h 0 250 10 15 min 24 h 15 min 30 min 1 h 1 ...

Page 200: ...r both presetting beeps and vibration AA ALKALINE or AA NiMH rechargeable battery presetting AA ALKALINE battery turned on or off presetting off turned on 1 24 h or off 0 h presetting off turned on or off when on once or every day s occurrence presetting off European 24 h or American 12 h am pm presetting European European dd mm yy or American mm dd yy presetting European 198 Technical data Note t...

Page 201: ...IR Infrared I U IU International Units in context with biological effectiveness of a certain insulin amount kPa Kilo pascals LCD Liquid Crystal Display LED Light Emitting Diode for infrared communication with e g a PC NiMH Nickel metal hydride used with rechargeable batteries rel Relative sec Second s TBR Temporary Basal Rate U See I U U h Amount of International Units of insulin delivered per hou...

Page 202: ... This is the insulin concentration Each millilitre of liquid contains 100 International Units of insulin dd mm yy European date format day month year mm dd yy American date format month day year 200 Annexes ...

Page 203: ...ncrement when programming a Quick Standard bolus Each press of f respectively confirm the STOP Warning Temporary basal rate active Unlock the KeyLock in RUN enter the RUN or INFO screen start a temporary basal rate Lock the KeyLock in RUN Unlock the KeyLock in STOP enter STOP screen Lock the KeyLock in STOP Exit a screen Cancel a running bolus or stop priming Start up procedure successfully conclu...

Page 204: ...ou cannot turn off these vibrations Your Accu Chek insulin pump vibrates when Short vibration Your Accu Chek Spirit performs a start up procedure medium vibration Your Accu Chek Spirit confirms the programmed bolus amount of the Quick Standard bolus Long vibration You reset the Quick Standard bolus amount to zero You cancel the Quick Standard bolus or When the STOP Warning occurs See the sections ...

Page 205: ...zed using antiseptics Year of manufacture Batch number Expiration date Item number Serial number Admissible temperature range during operation Admissible temperature range Admissible humidity range Admissible air pressure range Fragile handle with care Protect against moisture Protect from heat and sunlight 203 Annexes ...

Page 206: ... IEC 60601 1 Protection against electrical shock Symbol for protection against the effect of temporary immersion of water up to 60 minutes and 2 5 meters 8 feet according to IEC 60529 Marking of conformity according to the European Medical Device Directive MDD 93 42 EEC with the number of the notified body Federal law USA restricts this device to sale by or on the order of a physician Manufacturer...

Page 207: ... the KeyLock function is turned on Change the cartridge menu and cartridge content Cartridge low warning Empty cartridge Low battery Empty battery Regular AA battery Rechargeable AA battery Amount of International Units of insulin delivered per hour Basal rate profile Temporary basal rate TBR percentage Daily basal rate total Basal rate programming unlocked Basal rate programming locked 205 Annexe...

Page 208: ...temporary basal rate 110 200 h Remaining duration of an ongoing Extended bolus MultiWave bolus TBR or automatic off Daily total of insulin delivered basal rate plus boluses Prime the infusion set menu Alert or error occurring Alert Error Information menu Pump Timer Select the user menus STANDARD ADVANCED or CUSTOM SETUP MENU STANDARD menu SETUP MENU ADVANCED menu Beeps turned on Vibrations turned ...

Page 209: ...date format Alarm clock turned on Alarm clock turned off Single alarm when set an alarm clock Every day repeat alarm when set an alarm clock PC communication Menu key Check key Up key Down key Timeout of a menu This setting may have been changed by using your pump programming software 207 Annexes ...

Page 210: ...stics recommends that infusion sets are changed every two to three days or at the recommendation of your doctor or healthcare team Name Accu Chek 3 15 ml Plastic Cartridge Aventis Insuman Infusat Pre filled 3 15 ml Glass Cartridges U100 Comments Plastic cartridges are single use items only Do not reuse cartridges Refer to the instructions for use of the insulin you are using for information on the...

Page 211: ... pattern 50 U day using U100 insulin operating temperature 22 C 3 C 72 F 6 F the rechargeable battery life is approximately one week Rechargeable batteries are not provided by Roche Diagnostics Use only a battery charger officially recommended by the battery manufacturer Replace your battery cover with every 4th battery Roche Diagnostics offers a wide range of carrying system solutions to best fit...

Page 212: ...210 ...

Page 213: ... cover your basic insulin needs In insulin pump therapy your basal rate is determined together with your doctor or healthcare team and can be adjusted to meet your individual physiological needs throughout the day Your basal rate is delivered by your insulin pump according to the curve of your personal basal rate profile or profiles Basal rate profile Your insulin pump offers the option of deliver...

Page 214: ...lin pump for the cartridge Daily insulin total The total amount of insulin delivered basal rate plus boluses delivered 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 gluco...

Page 215: ...n pump to your body The insulin is delivered from the cartridge through the infusion set tubing and cannula or needle into your subcutaneous tissue Infusion sets can be disconnectable and non disconnectable 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 transform glucose into energy In...

Page 216: ...variable values which can be tailored to your individual needs on your insulin pump or using Accu Chek Insulin Pump Configuration Software RUN During normal use your insulin pump is in RUN and insulin is continuously delivered Boluses temporary basal rates and almost all functions can be programmed from RUN RUN screen The RUN screen is the starting point for all functions which can be accessed whi...

Page 217: ...ulin 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 insulin pump automatically returns to the RUN or STOP screen if no key is pressed within a certain time limit Any change...

Page 218: ...216 ...

Page 219: ...y depleted 153 type 112 179 Beeps 109 adjusting the volume 109 beeps and vibrations 145 Blood glucose 168 checking 169 Bolus 95 cancelled 151 cancel an Extended 124 cancel a MultiWave 129 cancel a Quick Standard 99 increment 136 Extended 95 122 MultiWave 95 126 program an Extended 123 program a MultiWave 127 program a Quick Standard 95 97 Bolus history 114 Cartridge 37 52 air bubbles in the 57 car...

Page 220: ... Entry number 114 116 117 Errors 152 Exit options 77 Graphic LCD 25 Guarantee 23 Hygiene 67 Index Infection 66 Infusion set 38 changing 69 disconnectable 38 instructions for use 67 non disconnectable 38 not primed 162 priming 64 Infusion site 66 preparation 66 selection 66 Insulin 11 116 213 expired 168 Insulin delivery 92 93 start 92 stop 93 Insulin pump 25 169 175 177 Insulin pump therapy contin...

Page 221: ...sion set 64 stop 66 Products 35 Profile 87 131 Programming 88 103 additional basal rates 131 Pump 25 stopping the 93 storing 180 storing conditions 181 wearing 73 Pump programming software 44 Pump therapy 9 11 Pump timer 114 118 149 Quick info screen 119 Repair 182 Review time and date 148 RUN 32 Safety 29 Self test 49 Screen 49 Scrolling 77 Selecting profile 132 Setup menu standard 107 Setup menu...

Page 222: ...increase 102 interruption of 106 over 151 Time 114 116 117 118 Time and date american 83 european 83 review 86 setting 83 Time format 134 Time remaining 118 Troubleshooting 165 ff Tubing 39 UP key 27 User menu advanced 78 121 custom 78 121 standard 78 83 Water 172 accidental contact 173 Wireless communication 141 Index ...

Page 223: ... alarm history daily insulin totals TBR history maintenance set the time and date set the hour set the minute set the year set the month set the day setup menu standard display orientation KeyLock beep volume alarm signals automatic off battery type program profile no 1 daily basal rate total 1st hour 2nd hour 24th hour KeyLock quick info Your Insulin pump ADVANCED MENU Your Insulin pump STANDARD ...

Page 224: ... tion was intended and program a new bolus if necessary Page 147 148 148 149 149 150 151 151 No Error E1 CARTRIDGE EMPTY E2 BATTERY DEPLETED E3 AUTOMATIC OFF E4 OCCLUSION E5 END OF OPERATION E6 MECHANICAL ERROR E7 ELECTRONIC ERROR E8 POWER INTERRUPT E10 CARTRIDGE ERROR E11 SET NOT PRIMED E12 DATA INTERRUPTED E13 LANGUAGE ERROR What you have to do Change the cartridge Change the battery Put your Ac...

Page 225: ......

Page 226: ... 04 07 ACCU CHEK ACCU CHEK SPIRIT ACCU CHEK TENDERLINK ACCU CHEK FLEXLINK ACCU CHEK RAPIDLINK and DISETRONIC are trademarks of Roche Disetronic Medical Systems AG 3401 Burgdorf Switzerland www accu chek com Swiss made ...

Search results

Summary of Contents for Spirit

Reviews:

Related manuals for Spirit

Brands by name

Popular brands

Accu-Chek Spirit, User Manual

Search results

Summary of Contents for Spirit

Reviews:

Related manuals for Spirit

Brands by name

Popular brands