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General Technical Data

Maximum time for an Error
E4: OCCLUSION**

Plastic cartridges:

at medium basal rate 1.0 U / h: ≤ 2 h

at minimum basal rate 0.05 U / h: ≤ 24 h

Aventis Insuman Infusat glass cartridges***:

at medium basal rate 1.0 U / h: ≤ 8 h

at minimum basal rate 0.05 U / h: ≤ 120 h

Maximum volume before Error
E4: OCCLUSION**

Plastic cartridges: ≤ 1.5 U
Aventis Insuman Infusat glass cartridges***: ≤ 5.0 U

Maximum pressure

400 kPa (4.0 bar), for plastic and Aventis Insuman Infusat glass cartridges*** and infusion
sets.

Flow (delivery rate)

During infusion set priming and bolus: 0.2 U / sec.

Maximum quantity delivered at
a single fault condition

≤ 1.0 U

Cartridge

Accu-Chek Spirit 3.15 ml Cartridge System and Accu-Chek 3.15 ml Plastic Cartridge with a
luer connection. Aventis Insuman Infusat cartridges*** have been evaluated and approved
for use with the Accu-Chek Spirit Combo insulin pump.

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Содержание ACCU-CHEK Spirit Combo

Страница 1: ...e those of their respective owners ACCU CHEK ACCU CHEK SPIRIT COMBO ACCU CHEK AVIVA COMBO PERFORMA COMBO ACCU CHEK TENDERLINK ACCU CHEK FLEXLINK ACCU CHEK RAPIDLINK ACCU CHEK RAPID D LINK and ACCU CHE...

Страница 2: ...pump Adapter Luer lock of infusion set Cartridge compartment with cartridge United Kingdom Distributed in the United Kingdom by Roche Diabetes Care Limited Charles Avenue Burgess Hill West Sussex RH1...

Страница 3: ...nd accessories Cartridge plunger End plate Piston rod Adapter Battery Battery cover Battery key Cartridge Infrared window next to Battery cover Cartridge Compartment man_05957613001_E_en indb 1 02 03...

Страница 4: ...ously to move backwards j j Press f to select or save j j Press a to go up j j Press s to go down BRP Basal Rate Profile 2 4 Overview of ADVANCED user menu f f BRP 4 BRP 3 BRP 2 BRP 4 BRP 3 BRP 2 RUN...

Страница 5: ...e sold separately j j Press d to move forwards j j Press d a simultaneously to move backwards j j Press f to select or save j j Press a for up j j Press s for down not accessible in STANDARD user menu...

Страница 6: ...as been developed exclusively for the continuous subcutaneous delivery of U100 short acting insulin or fast acting insulin analogue Whether insulin pump therapy is the appropriate way of treating your...

Страница 7: ...ing informs you about risks to your health Neglecting this information may even lead to life threatening situations in some cases j j A Caution informs you about risks to your device Malfunction or da...

Страница 8: ...man_05957613001_E_en indb 6 02 03 2015 10 43 53...

Страница 9: ...Wearing your pump 61 3 2 Interruption of insulin pump therapy 64 3 3 Your insulin pump and water 67 3 4 Changing the infusion set 69 3 5 Changing the cartridge and infusion set 73 3 6 General safety i...

Страница 10: ...ing of your pump 150 8 Warnings and Errors 151 8 1 Confirming a Warning or Error 152 8 2 List of Warnings 153 8 3 List of Errors 159 8 4 List of Reminders 170 9 Troubleshooting 171 9 1 Therapy related...

Страница 11: ...new product is an intelligent blood glucose meter that can remote control the pump using Bluetooth wireless technology Three user menus Your Accu Chek Spirit Combo insulin pump has been designed to ad...

Страница 12: ...m a Quick Bolus without looking at the display screen and check that it is correctly programmed by counting the beeps and vibrations This is particularly useful when you want to program the bolus disc...

Страница 13: ...tal activation of functions For example you can use Key Lock while you are asleep or when playing sports 1 2 Display and sounds Your Accu Chek Spirit Combo insulin pump has a Liquid Crystal Display LC...

Страница 14: ...mming with the a 1 2 2 Rotating display Your pump s display can be rotated through 180 degrees See section 5 6 4 Display orientation Note that when you rotate the display the s and a key functions are...

Страница 15: ...reen you have to press any key before any other operation can be performed RUN screen By default the screen is blank to save energy and becomes blank again after 20 seconds By pressing any key the RUN...

Страница 16: ...d Pump timer Cartridge low Battery low Time Date The STOP screen also displays Reminder information such as battery low and special functions such as Key Lock locked or unlocked in the form of symbols...

Страница 17: ...s See section 1 2 3 Display screens 1 Press the d key to select a screen of your choice 2 Press the d key again to see the next available choice in the menu After you reach the last menu choice you wi...

Страница 18: ...able to hear and or feel the beeps and vibrations Be aware that some carrying pouches may hinder the perceptibility of the signals You can turn off either beeps or vibrations but for your safety you...

Страница 19: ...your safety the volume of the STOP Warning cannot be changed It is independent of the programmed beep volume 1 3 Keys and key combinations You use the 4 keys on the Accu Chek Spirit Combo insulin pump...

Страница 20: ...el a Quick Bolus j j Turn off the STOP Warning press and hold 3sec until you hear a melody Key Name Function s Down j j Move backward in the information screens j j Decrease a setting j j Program a Qu...

Страница 21: ...and information screens without saving your changes j j Moves you to a previous menu d s j j Unlocks the keys Press and hold both buttons until you hear 3 short beeps RUN mode or 3 long beeps STOP mod...

Страница 22: ...es the increment of the value change increases if you keep the a or s key pressed When you begin scrolling the pump beeps once 1 3 3 Locking the keys The Key Lock feature enables you to lock all 4 key...

Страница 23: ...or or healthcare team 1 4 1 Sterile disposables Each sterile disposable such as cartridge or infusion set should be used only once as re using these products could lead to infection or could damage yo...

Страница 24: ...ing Note It is essential to change the adapter at least every 2 months You must also change the adapter if the seals become worn are lost or if the vents are blocked 1 4 3 Battery Your pump requires o...

Страница 25: ...rve the battery Battery cover The battery cover seals the battery compartment and must be changed at least every 2 months You must remove and replace the battery cover using the battery key do not use...

Страница 26: ...Cartridge System j j An insulin pen or syringe for alternative therapy j j A vial of insulin j j Treatment for low blood glucose levels j j Blood glucose monitoring equipment such as an Accu Chek bloo...

Страница 27: ...in pump has not been tested with cardiac pacemakers For information about the safe use of your Accu Chek Spirit Combo insulin pump with a cardiac pacemaker contact the pacemaker manufacturer For refer...

Страница 28: ...24 man_05957613001_E_en indb 24 02 03 2015 10 43 55...

Страница 29: ...battery See section 1 4 3 Battery for information on batteries both disposable and rechargeable types This chapter explains how to prepare your pump and begin insulin pump therapy 2 1 Before you begi...

Страница 30: ...r Use the battery key to turn the battery cover anti clockwise Make sure that the opening of the battery compartment and the seal are clean and undamaged Where appropriate remove the old battery 3 Pro...

Страница 31: ...hat the battery cover is correctly tightened by checking that it is in line with the pump casing Do not over tighten After inserting the battery the pump begins its start up process see section below...

Страница 32: ...attery is correctly inserted Note If your pump was in RUN mode before you removed the battery the Error E8 POWER INTERRUPT will occur when the new battery is inserted Press f twice to confirm and snoo...

Страница 33: ...s performed When you Then change only the cartridge the start up process begins at the SELF TEST screen w Warning Do not interrupt the start up process by pressing keys or otherwise handling the insul...

Страница 34: ...g the pump and contact your local pump support See inside back cover The VIBRATION TEST screen appears and your pump vibrates Check the vibrations w Warning If you cannot feel the vibrations you may n...

Страница 35: ...s is signalled by a melody and the pump displays the STOP screen The STOP Warning occurs every minute To turn the STOP Warning off press a or s until you hear a melody and or feel a vibration When you...

Страница 36: ...d date can lead to incorrect basal insulin delivery Make sure that the time and date of your pump are set correctly to ensure correct delivery and data memory Do not make therapy decisions based on a...

Страница 37: ...yed Press a or s to set the hour Press d to move to the MINUTE screen Press a or s to set the minute 4 5 6 Press d to move to the YEAR screen Press a or s to set the year Press d to move to the MONTH...

Страница 38: ...move to the TIME FORMAT screen Press a or s to set the time format Press d to move to the DATE FORMAT screen Press a or s to set the date format Press f to save and exit man_05957613001_E_en indb 34 0...

Страница 39: ...profiles to match your changing insulin needs for example Monday to Friday Exercise Day or Sleeping Late Day Note For your safety and convenience during programming your Accu Chek Spirit Combo insuli...

Страница 40: ...ery does not stop or pause during basal rate programming 3 Procedure for programming your basal rate profile 1 2 Press d to move to the BASAL RATE PROGRAMMING 1 2 3 4 or 5 accord ingly screen Press f...

Страница 41: ...s you to program your individual basal rate profile on an hour by hour basis Continue until all 24 hours are programmed 6 7 Press f to confirm The new daily BASAL RATE TOTAL is displayed Press f to sa...

Страница 42: ...can save time by copying an hourly basal rate to one or more hours 1 3 Press d to move to the hourly basal rate you want to copy 4 5 Press a and s simultaneously A special beep confirms that you are p...

Страница 43: ...you want to Then save the changes j j Press f and check the new daily basal rate total j j Press f again Your pump returns to the RUN or STOP screen undo the changes j j Wait for your Accu Chek Spirit...

Страница 44: ...daily basal rate total appear accordingly Press f to select the displayed profile The new basal rate profile is active immediately 4 1 2 3 When you have programmed more than one basal rate profile AD...

Страница 45: ...l rate and bolus During normal use your pump is in RUN mode and insulin is continuously delivered to your body according to the basal rate profile you have programmed A bolus can be programmed as requ...

Страница 46: ...the cartridge move the piston rod to the correct position and twist the adapter until the cartridge plunger is aligned with the end plate of the piston rod See section 3 5 Changing the cartridge and i...

Страница 47: ...ctor until it stops Do not over tighten or use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage of insulin Remove the protective cap from the cartridge...

Страница 48: ...usion set Procedure for inserting the cartridge Press d to move to the STOP YOUR PUMP screen Press f to select The pump displays the STOP screen and insulin delivery stops Disconnect the infusion set...

Страница 49: ...ly the CARTRIDGE VOLUME screen displays the maximum volume 315U 4 Press d to move to the CARTRIDGE CHANGE screen Press f to select 5 Remove the cartridge if necessary Unscrew carefully Do not pull the...

Страница 50: ...rt of the adapter is level with the top of the cartridge compartment 10 Press a or s to move the piston rod forward until the end plate of the piston rod is level with the bottom of the cartridge plun...

Страница 51: ...tridge plunger remove the cartridge from the cartridge compartment and repeat steps 9 to 14 15 16 17 Twist do not push the adapter clockwise until it is correctly seated against the cartridge compartm...

Страница 52: ...ction 2 8 Priming the infusion set Start from step 4 in the Procedure for priming the infusion set 19 c Caution If an empty cartridge is inserted into the pump e g for training purposes the pump displ...

Страница 53: ...with insulin When insulin appears at the tip of the needle press f to stop priming The amount of insulin used for priming is not added to the pump s history of daily insulin totals Your pump should be...

Страница 54: ...ins 5 Procedure for priming the infusion set Press d to move to the STOP YOUR PUMP screen Press f to select 1 2 3 The pump displays the STOP screen and insulin delivery stops Prepare the tubing or can...

Страница 55: ...and a drop of insulin has come out of the needle When the priming process is complete your pump returns to STOP A count up is shown on the display Your pump stops priming after 25 units You can stop...

Страница 56: ...planned rotation pattern Avoid your waistline bones scar tissue recent infusion sites bruises and sores Choose an infusion site at least one inch 2 5cm away from the navel and previous infusion sites...

Страница 57: ...cu Chek infusion set according to the instructions 2 5 4 2 9 2 Inserting the cannula Make sure that your pump is properly connected including cartridge adapter and infusion set and correctly pro gramm...

Страница 58: ...lure to do so could result in missed insulin dosing See section 4 2 Programming a Standard Bolus w Warning Inspect your infusion site at least twice a day for irritation or infection Signs of infectio...

Страница 59: ...for starting insulin delivery 1 2 3 Your pump is in STOP mode Press d to move to the START YOUR PUMP screen Press f to select Your pump shows the RUN screen Insulin delivery begins within 3 minutes ma...

Страница 60: ...riming the infusion set j j data transfer c Caution When your Accu Chek Spirit Combo insulin pump is in STOP mode no insulin is delivered to your body You must put your pump into RUN mode to continue...

Страница 61: ...endent of the programmed beep volume 2 12 General safety information w Warning The cartridge and infusion set are sterile products intended for single use only Sterility is guaranteed for unopened pac...

Страница 62: ...change your settings after consulting your doctor or healthcare team w Warning The support of a doctor or healthcare team is vital when training on and using your Accu Chek Spirit Combo insulin pump...

Страница 63: ...too low the start up process may not be able to complete In this case the pump beeps five tones and keeps restarting the process until you remove the battery or until it is empty Note Check the amoun...

Страница 64: ...60 man_05957613001_E_en indb 60 02 03 2015 10 44 15...

Страница 65: ...accidentally press its keys e g key chains keys pocket knives or coins 3 1 1 When not to wear your pump Electromagnetic fields and hazardous areas w Warning Do not use your pump near electromagnetic f...

Страница 66: ...top and remove your pump before you enter these areas If you have questions contact your local pump support see inside back cover Your pump is designed to work in normal barometric conditions from 500...

Страница 67: ...situations 3 1 3 Travelling with your pump Ask your doctor or healthcare team about any special steps you need to take before you travel Take extra blood glucose testing and pump supplies with you an...

Страница 68: ...team w Warning Because only fast or rapid acting insulin is used for insulin pump therapy only a small amount of insulin is stored in the body If insulin delivery is interrupted for any reason such as...

Страница 69: ...se the protective covers that came with it Resuming insulin delivery Reconnect your infusion set or insert a new one and put your pump into RUN mode 1 Where appropriate attach a new Accu Chek infusion...

Страница 70: ...edure 1 Put your pump into STOP mode Remove the cartridge adapter and infusion set Reinsert the adapter 2 3 2 2 Long interruptions Remove the battery and reinsert the battery cover Store your pump pro...

Страница 71: ...ove your pump before taking a bath or going into a whirlpool shower or swimming pool Avoid exposing your pump to high humidity such as in a sauna as this could result in damage To make it easy to remo...

Страница 72: ...are completely dry See section 7 5 1 Cleaning your pump Other liquids You do not need to worry about contact between your pump and perspiration or saliva You must however check your pump immediately a...

Страница 73: ...t in leakage j j Your pump cannot detect infusion set leakage You should inspect all parts of your infusion set regularly during the day and before you go to sleep If there seems to be any loss of ins...

Страница 74: ...to loosen the luer lock connector from the adapter if it cannot be loosened by hand Tip The battery key has a notch that fits 4 Procedure for changing the infusion set Have the following materials rea...

Страница 75: ...tighten the luer lock connector by hand 6 9 10 11 Prime the infusion set following the instructions found in section 2 8 Priming the infusion set Prepare the infusion site and insert a new infusion s...

Страница 76: ...Warning Inspect your infusion site at least 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...

Страница 77: ...nfusion set 3 5 Changing the cartridge and infusion set Have the following materials ready j Your Accu Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu Chek infusion set j A...

Страница 78: ...down wards 6 Remove the transfer set from the adapter and dispose of it correctly Remove the cartridge from the adapter and dispose of the cartridge properly Tip The battery key has a notch that fits...

Страница 79: ...dge 9 Hold the adapter to the light to check for signs of wear or dirt especially on the seals inside and outside of the adapter If necessary clean the adapter using water and dry it If it shows signs...

Страница 80: ...tures over 104 F 40 C and below 41 F 5 C These conditions may damage the insulin and the housing of your insulin pump and could also cause a malfunction of the battery See the instructions for the in...

Страница 81: ...od glucose level your food intake your health condition and your activity level Discuss the timing the amount and type of bolus you need with your doctor or healthcare team Your pump can deliver 3 typ...

Страница 82: ...50 units using U100 insulin After you program a Standard Bolus there is a delay of 5 seconds before bolus delivery starts This delay allows you to cancel the bolus by pressing the a or s key The Warni...

Страница 83: ...a until you hear a beep sequence and feel a vibration This activates the Quick Bolus function Press a s once for each increment until the required bolus amount is reached You must not use the key you...

Страница 84: ...the bolus increment 5 seconds after the last press of a s your pump confirms the total bolus amount with one beep and vibration for each bolus increment programmed The Standard Bolus symbol blinks for...

Страница 85: ...N screen A Warning W8 BOLUS CANCELLED occurs Press f twice to confirm and turn off the alert See chapter 8 Warning W8 BOLUS CANCELLED No bolus is delivered During bolus delivery countdown of bolus amo...

Страница 86: ...andard Bolus screen by holding the a or s key scrolling until the bolus amount is displayed 2 3 1 Press d to move to the Standard Bolus screen Press f to select The BOLUS AMOUNT screen appears Press o...

Страница 87: ...d a simultaneously j Set the bolus amount to 0 0 units Press f to exit No bolus is delivered During the start delay Standard Bolus symbol blinks Press d a s or a You hear a melody Your pump returns to...

Страница 88: ...s delivery can be programmed in 15 minute intervals up to 12 hours and begins immediately after confirma tion Throughout the bolus delivery the remaining time and amount of the Extended Bolus and the...

Страница 89: ...or Quick 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...

Страница 90: ...isplayed in the RUN screen 4 5 Press d to move to the BOLUS DURATION screen Press a to increase or s to decrease the bolus duration Tip Press d to switch between programming the bolus amount and bolus...

Страница 91: ...bolus delivery j If the Extended Bolus delivery has begun it can be cancelled by putting your pump into STOP mode This cancels the bolus delivery and a Warning W8 BOLUS CANCELLED is displayed Press f...

Страница 92: ...and turn off the first Warning The second alert appears on the display Press f twice to confirm and turn off the second Warning Both alerts are recorded in the Warnings history See chapter 8 Warning W...

Страница 93: ...for up to 12 hours Note j The Multiwave Bolus is available only in the ADVANCED user menu j j You can add a Standard Bolus to an ongoing Multiwave Bolus If you cancel the Standard Bolus the Multiwave...

Страница 94: ...st Multiwave Bolus and a default immediate bolus amount appear The latter increases or decreases proportionally as you increase or decrease the total bolus amount Press d to move to the IMMEDIATE BOLU...

Страница 95: ...The Multiwave Bolus symbol blinks for 5 seconds bolus delivery start delay 8 The pump beeps 3 times and vibrates The immediate bolus delivery begins The countdown of the remaining bolus continues to...

Страница 96: ...immediate delivery by pressing and holding s or a for 3 seconds until you hear a melody This cancels the whole bolus immediate and Extended Bolus delivery Bolus delivery is interrupted During extended...

Страница 97: ...BR Your pump allows you to temporarily increase or decrease your basal rate This enables you to match your changing insulin needs due to increased or decreased activity level illness or stress Typical...

Страница 98: ...RUN mode Procedure for programming a Temporary Basal Rate 1 2 Press d to move to the Temporary Basal Rate TBR screen Press f to select The TBR PERCENTAGE screen appears Note If no Temporary Basal Rate...

Страница 99: ...or the first time a default value appears Press d to move to the TBR DURATION screen Press a or s to correct and set the duration 3 5 Tip You can switch between program ming the basal rate percentage...

Страница 100: ...emporary Basal Rate decrease Note If 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 ba...

Страница 101: ...During delivery There are 2 ways to cancel a Temporary Basal Rate during delivery j Set the TBR percentage to 100 Press f to save and exit A Warning W6 TBR CANCELLED is displayed j Or you can put your...

Страница 102: ...ral safety information w Warning j Incorrect programming of your insulin pump may cause inappropriate insulin delivery j Your insulin pump must be programmed with your personal settings before startin...

Страница 103: ...k Spirit Combo insulin pump has been designed for use with the Meter This intelligent blood glucose meter enables you to communicate with the pump using Bluetooth wireless technology 5 1 1 User menus...

Страница 104: ...the Accu Chek Spirit Combo insulin pump has so many features you may want to decide which screens are displayed when you scroll through the menu choices Using appropriate PC software this menu enable...

Страница 105: ...cuss this with your doctor or healthcare provider 2 3 Procedure for selecting a user menu The SELECT USER MENU screen is displayed Press a or s to select a user menu Press f to confirm The selected ba...

Страница 106: ...al rate profile are active immediately c Caution A running increased or decreased Temporary Basal Rate will remain active even if you change the basal rate profile The Temporary Basal Rate is based on...

Страница 107: ...options from the STANDARD user menu To view the order in which they appear on the display refer to the menu diagram below j j Press d to move forwards j j Press d a simultaneously to move backwards f...

Страница 108: ...set START YOUR PUMP j j See section 2 10 Starting insulin delivery STOP YOUR PUMP j j See section 2 11 Stopping insulin delivery Quick Bolus j j See section 4 2 1 Programming a Quick Bolus STANDARD BO...

Страница 109: ...a personal computer using Accu Chek software products The following data can be reviewed directly on your Accu Chek Spirit Combo insulin pump Bolus history last 30 boluses Alarm history last 30 Warni...

Страница 110: ...appears showing the most recent bolus informa tion Press a or s to view the entries Press f to exit Each BOLUS DATA screen displays j j Bolus type Standard Extended or Multiwave Bolus j j Bolus durat...

Страница 111: ...o the MY DATA screen Press f to select Press d to move to the ERROR DATA screen Press a or s to view the entries Press f to exit Each alarm data screen displays j j Number and type of the Warning or E...

Страница 112: ...cent entry 1 2 3 Procedure for viewing the daily insulin totals Press d to move to the MY DATA screen Press f to select Press d to move to the DAILY TOTALS screen Press a or s to view the entries Pres...

Страница 113: ...Basal Rate history Press d to move to the MY DATA screen Press f to select Press d to move to the TBR DATA screen Press a or s to view the entries Press f to exit Each TBR DATA screen displays j j TB...

Страница 114: ...2 in the RUN and STOP screen When the operating time has expired you will be prompted with an Error E5 or E9 END OF OPERATION and the pump will turn to STOP mode After an Error E5 or E9 the pump cann...

Страница 115: ...to a total of 4500 events This data corresponds to about the last 90 days of use and can be accessed on a personal computer using Accu Chek 1 2 3 Procedure for transferring your data information mana...

Страница 116: ...t in RUN mode if necessary Note Your pump will return to STOP mode 15 minutes after the last data transfer when the DATA TRANSFER screen is selected You can press twice d a to exit while data is being...

Страница 117: ...that prevents you from accidentally activating functions for example while sleeping or during contact sports If the Key Lock is turned on and no key is pressed for 10 seconds after your pump has retu...

Страница 118: ...is pressed for 10 seconds after your pump has returned to the RUN or STOP screen all 4 keys are automatically locked Procedure for unlocking the Key Lock If you press any key while the screen is blan...

Страница 119: ...lume of the STOP Warning is independent of the programmed beep volume it always sounds at the maximum level If the beeps are turned off and a Warning or Error occurs the beeps become active again to e...

Страница 120: ...re for changing the signal settings Beep only Vibrate only Beep and vibrate For your safety if you do not respond to the vibration the pump starts beeping after one minute 1 2 Press d to move to the P...

Страница 121: ...TTINGS screen Press f to select Press d to move to the ORIENTATION screen The current orientation is displayed Press a or s to select the display orientation Press f to save and exit Note If you turn...

Страница 122: ...suit your preferences Procedure for setting the display contrast Press d to move to the PUMP SETTINGS screen Press f to select Press d to move to the DISPLAY CONTRAST screen Press a or s to select the...

Страница 123: ...u can chose the language according to your preferences Procedure for setting the language Press d to move to the PUMP SETTINGS screen Press f to select Press d to move to the LANGUAGE screen Press a o...

Страница 124: ...ED user menu To view the order in which they appear on the display refer to the menu diagram below BRP 4 BRP 3 BRP 2 BRP 4 BRP 3 BRP 2 f f RUN STOP j j Press d to move forwards j j Press d a simultane...

Страница 125: ...or Sleeping Late Day Discuss additional basal rate profiles with your doctor or healthcare team Also consult with your doctor or healthcare team before changing basal rate profiles as this may affect...

Страница 126: ...te profile are set in the same way as for basal rate profile 1 See section 2 5 1 Programming your basal rate profile Note Only basal rate profiles that are accessible in your current user menu are ava...

Страница 127: ...ile is active immediately Note Only basal rate profiles that are accessible in your current user menu are available A running Temporary Basal Rate increase or decrease stays active even if you change...

Страница 128: ...ture to remind you for example when you need to test your blood glucose 1 2 3 Procedure for setting single or multiple Reminders Press d to move to the Reminder SETTINGS screen Press f to select The c...

Страница 129: ...UTE screen Press a or s to set the minute Press f to save and exit Turning off the Reminder When the Reminder sounds the Reminder screen is displayed Press f twice to snooze and confirm and return to...

Страница 130: ...is adjustable It is initially set to 0 5 units per key press but it can be changed to 0 1 0 2 0 5 1 0 or 2 0 units w Warning The bolus increment determines the Quick Bolus amount per key press using t...

Страница 131: ...ting for the prime amount 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 1 2 Procedure for adjusting the prime amount P...

Страница 132: ...blocked If you try to program a basal rate while the BASAL RATE LOCK is turned ON the key symbol in the BASAL RATE TOTAL screen indicates that basal rate programming is locked The a and s functions a...

Страница 133: ...uss using the Automatic off function with your doctor or healthcare team 1 2 3 Procedure for using Automatic Off Press d to move to the THERAPY SETTINGS screen Press f to select Press d to move to the...

Страница 134: ...cial requirements and preferences It allows you or your healthcare provider to display or hide screens and thereby customize the individual user menus j j Press d to move forwards j j Press d a simult...

Страница 135: ...ilable except the following j j Multiwave Bolus j j Basal rate profiles 3 4 and 5 j j Therapy Settings To change the CUSTOM user menu you your doctor or your healthcare provider must use the Accu Chek...

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Страница 137: ...here is no risk of your pump receiving signals from any other device Note The pump cannot communicate with the Meter using Bluetooth wireless technology when the devices are more than 2 meters apart 6...

Страница 138: ...e infusion set j j Data transfer j j Bluetooth settings j j Display settings All the other functions available on the Accu Chek Spirit Combo insulin pump can be performed using the Meter Before using...

Страница 139: ...the battery life and avoid accidental changes on your pump you should switch off Bluetooth wireless technology if the Meter is lost stolen or you plan not to carry it with you for a longer period of t...

Страница 140: ...table or desk so that you can see the displays of both devices clearly 1 2 3 Procedure for Pairing Press d to move to the BLUETOOTH SETTINGS screen Press f to select the ON OFF screen Press a or s to...

Страница 141: ...ce is available turn on the Meter in pairing mode by holding down and simultaneously pressing Press the d key on the pump to see the ADD DEVICE screen and press f to initiate pairing The pump begins s...

Страница 142: ...screen After the pairing is completed press to turn off the Meter The pump now shows the DEVICE PAIRED screen Press f to confirm the pairing The pump displays the PAIRED DEVICE screen You can return t...

Страница 143: ...re described in section 6 3 Pairing your pump with the Meter Since only one Meter at a time can be paired with your pump you must delete the pairing before you can pair your pump with a new Meter 1 2...

Страница 144: ...nd Meter behave in the following ways when Warnings and Errors occur j j If both devices are switched on and paired you can enter the Meter s Pump menu and snooze and confirm the Warning or Error thro...

Страница 145: ...u must ensure that Bluetooth is switched off on both devices before boarding an aircraft as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft man_05957...

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Страница 147: ...rly maintained to guarantee accurate insulin delivery Check the pump display regularly during the day and before you go to sleep and especially if for any reason you might not be able to hear the beep...

Страница 148: ...ositioned in line with the pump casing j j The adapter is correctly attached j j Your infusion set is primed free of air bubbles and tightly connected to the adapter j j Your infusion set is inserted...

Страница 149: ...your pump its sterile products and accessories for chips and cracks j j Change the cartridge if it is damaged Put your pump in STOP mode and take out and reinsert the battery so that the self test is...

Страница 150: ...heck daily that your Accu Chek Spirit Combo insulin pump is not chipped cracked or damaged in any way and that the battery cover and the adapter are correctly closed If the pump is chipped or cracked...

Страница 151: ...y Do not use warm air such as a hair dryer to dry the pump as this could damage the pump s housing Do not reinsert the battery or the cartridge until the compartments are completely dry See section 7...

Страница 152: ...ly pack the pump and the used cartridge battery battery cover adapter and infusion set to avoid damage during transportation Place your pump back in the shipping case and put the case in a package tha...

Страница 153: ...insulin pump during cleaning as this may accidentally change your settings Do not use other solvents strong detergents bleaching agents scouring pads or sharp instruments for cleaning as they may dama...

Страница 154: ...y carry a risk of infection Therefore it falls outside the scope of the European Directive 2002 96 EC and may not be disposed of with other electronic devices If you need to dispose of your Accu Chek...

Страница 155: ...feel the vibrations for any reason Your pump signals Warnings 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...

Страница 156: ...f to turn off the beeps and vibrations The Warning or Error code stays on the display j j As soon as you understand the reason for the Warning or Error confirm by pressing f again j j Take appropriate...

Страница 157: ...de to continue the insulin delivery Warning W1 CARTRIDGE LOW The content of the insulin cartridge has dropped to 20 units of insulin Be prepared to replace the cartridge as soon as possible The cartri...

Страница 158: ...ges j j If necessary put your pump in RUN mode See section 1 4 Accessories and disposables on recommended batteries See section 2 2 Inserting the battery for instructions on how to change the battery...

Страница 159: ...mode if necessary Warning W5 PUMP TIMER backup pumps only Your pump s operating time will expire soon When the Warning W5 PUMP TIMER occurs your pump has a remaining operating time of 30 days j j Pres...

Страница 160: ...Note The Warning W5 PUMP TIMER and the Error E5 END OF OPERATION are based on running time the total time the pump is in RUN mode and not on calendar years See section 5 4 5 Viewing the time remainin...

Страница 161: ...new Temporary Basal Rate Warning W8 BOLUS CANCELLED A bolus was cancelled during the start delay or after delivery began j j Press f twice to snooze and to confirm the Warning j j If necessary put yo...

Страница 162: ...RUN mode if necessary j j Go to the MY DATA menu on your pump j j Move to the PUMP TIMER screen The days until the loantime expires are shown Note This setting is country specific and may not be visi...

Страница 163: ...nd prime the infusion set j j Reconnect the infusion set or insert a new one j j Put your pump in RUN mode See section 3 5 Changing the cartridge and infusion set Error E2 BATTERY EMPTY The battery is...

Страница 164: ...rect See section 1 4 Accessories and disposables on recom mended batteries See section 2 2 Inserting the battery for instructions on how to change your battery Error E3 AUTOMATIC OFF Automatic Off is...

Страница 165: ...re team s instructions Insulin was not delivered This may be due to j j a blocked infusion set j j a damaged cartridge j j a dirty or damaged piston rod If an Error E4 OCCLUSION blockage occurs follow...

Страница 166: ...e to turn off and to confirm the Error j j Disconnect or remove the infusion set from your infusion site j j Remove the cartridge adapter and infusion set from your pump j j Carry out the Infusion set...

Страница 167: ...p soon If necessary use the alternative therapy plan provided by your doctor or healthcare team j j Press f twice to snooze and to confirm the Error j j Contact your local pump support see inside back...

Страница 168: ...g the cartridge Prime the infusion set See section 2 8 Priming the infusion set j j Reconnect the infusion set at your infusion site j j Put your pump in RUN mode If the Error E6 MECHANICAL ERROR occu...

Страница 169: ...NTERRUPT A power interrupt Error occurs when you insert a new battery without first placing the pump in STOP mode See section 2 2 Inserting the battery for instructions on how to change the battery Th...

Страница 170: ...tails on inside back cover to discuss the options for further use of the Accu Chek Spirit Combo insulin pump Note This setting is country specific and may not be visible on your pump The Warning W9 LO...

Страница 171: ...mp in RUN mode j j Press f twice to snooze and to confirm the Error j j Remove or disconnect the infusion set from your infusion site j j Prime the infusion set See section 2 8 Priming the infusion se...

Страница 172: ...y completed before you can put your Accu Chek Spirit Combo insulin pump into RUN mode Data transfer between your pump and the PC was interrupted before it was completed j j Press f twice to snooze and...

Страница 173: ...uage setting needs to be checked j j Press f twice to snooze and to confirm the Error j j Follow the steps in section 5 6 Pump settings to change the language j j Put your pump in RUN mode man_0595761...

Страница 174: ...urs Turn the Reminder function OFF if you do not want the alarm to go off again at that same time every day See section 5 9 Setting a Reminder Reminder R2 END OF WARRANTY The 4 year warranty covering...

Страница 175: ...on relating to the Bluetooth connection between the Meter and the Accu Chek Spirit Combo insulin pump is included in chapter 6 Using the Accu Chek Spirit Combo insulin pump with the Meter Also refer t...

Страница 176: ...p still does not beep or vibrate contact your local pump support details on inside back cover The self test is not completed correctly after an Error E7 ELECTRONIC ERROR Remove the battery wait a few...

Страница 177: ...at room tempera ture In the infusion set Disconnect from the headset and prime your infusion set Reconnect the headset and ensure that all connections are tight and secure The cartridge is empty Repla...

Страница 178: ...is an occlusion blockage in the system Check your blood glucose level Follow the instructions in chapter 8 Error E4 OCCLUSION Priming was not completed E11 or air bubbles in infusion set Disconnect f...

Страница 179: ...110g 3 9 ounces Pump casing Shock and scratch resistant plastic resistant to pharmaceuticals all edges rounded Temperature ranges During operation 5 to 40 C 41 to 104 F Storage in its shipping case 5...

Страница 180: ...lin operating temperature 23 C 2 C 73 F 4 F the battery life is approximately Alkaline 70 days for Bluetooth off 30 days for Bluetooth on Lithium 200 days for Bluetooth off 80 days for Bluetooth on Ni...

Страница 181: ...lin units The bolus amount for the Quick Bolus is adjustable in increments of 0 1 0 2 0 5 1 0 and 2 0 units For the Standard Bolus Extended Bolus and Multiwave Bolus the amount is adjustable in fixed...

Страница 182: ...man Infusat glass cartridges 5 0U Maximum pressure 400kPa 4 0bar for plastic and Aventis Insuman Infusat glass cartridges and infusion sets Flow delivery rate During infusion set priming and bolus 0 2...

Страница 183: ...ly 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 IPX8 Protected against the effects of t...

Страница 184: ...issions CISPR 11 Group 2 The Accu Chek Spirit Combo insulin pump must emit electro magnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions CI...

Страница 185: ...used in such an environment Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8kV contact 15kV air 8kV contac...

Страница 186: ...e Note UT is the A C mains voltage prior to application of the test level Immunity test standard IEC 60601 test level Compliance level Electromagnetic environment guidance Power frequency 50 60 Hz mag...

Страница 187: ...k Spirit Combo insulin pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Immunity test standard IEC 60601 test...

Страница 188: ...le 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 electromagn...

Страница 189: ...ended below according to the maximum output power of the communication equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150kHz to 80MHz...

Страница 190: ...s affected by absorption and reflection from structures objects and people Note An additional factor of 10 3 is used in calculating the recommended separation distance to decrease the likelihood that...

Страница 191: ...15 8 17 3 17 2 58 2 18 0 18 0 22 0 82 3 81 1 97 0 81 1 79 1 02 A 1 38 observation window duration min minimum measured variation maximum measured variation overall percentage Error The measurements w...

Страница 192: ...480 720 840 960 1320 0 010 0 008 time min real flow target flow 0 01ml is equivalent to 1 U U100 insulin Bolus For U100 insulin the maximum deviation of a maximum bolus is 5 and the maximum deviation...

Страница 193: ...to 10 0U h and 0 1 up to 50 0U h 0 0 0 05U h 50 0U h Hourly basal rates 25 0 U h max amount 0 50 0U h Temporary Basal Rate TBR increases or decrease in increments of TBR duration TBR duration incremen...

Страница 194: ...us amount increments for Standard Bolus bolus duration Extended Bolus Multiwave Bolus bolus duration increments 0 5U 0 1U max 12h 15min 0 1 0 2 0 5 1 0 or 2 0U 15min 50h 15min 30min 1h Prime volume 25...

Страница 195: ...c off turned on 1 24h or off 0h Reminder turned on or off when on once or every day s occurrence Time format European 24h or American 12h am pm Date format European dd mm yy or American mm dd yy Bluet...

Страница 196: ...t cartridge has not been licensed for sale in Canada Accu Chek infusion sets Name Comments Accu Chek RapidLink Accu Chek Rapid D Accu Chek Rapid D Link Accu Chek Tender Accu Chek TenderLink Accu Chek...

Страница 197: ...time of battery Rechargeable batteries are not provided by Roche Use only a battery charger officially recommended by the battery manufacturer Name Comments Carrying Systems All Accu Chek Spirit Combo...

Страница 198: ...al Display LED Light Emitting Diode for infrared communi cation with e g a PC Abbreviation Meaning NiMH Nickel Metal Hydrid used with rechargeable batteries rel Relative sec Seconds TBR Temporary Basa...

Страница 199: ...ms 20 Duration for short pause 125 0ms 20 Duration for medium pause 218 75ms 20 Duration for long pause 500 0ms 20 UP KEY Frequency 3131Hz 5 Duration Short sound Sound Function DOWN KEY Frequency 2486...

Страница 200: ...ause long sound BASE STATE STOP KEYS LOCKED Frequency 2763Hz 5 Duration Long sound short pause long sound short pause long sound Sound Function CARTRIDGE CONTENT 20 U Frequency f1 2090Hz 5 f2 2486Hz 5...

Страница 201: ...sound f2 short sound long pause f3 long sound SYSTEM TEST SUCCESSFUL Frequency 1043Hz 5 1314 Hz 5 1563Hz 5 2090Hz 5 Duration 4 long sound Sound Function COPY BASAL RATE Frequency 2486Hz 5 3131Hz 5 24...

Страница 202: ...f2 medium sound short pause f2 medium sound Repeating Interval 3000 0ms 20 Sound Function ERROR REPEATING SEQUENCE Frequency f1 1043Hz 5 f2 1850Hz 5 Duration f1 medium sound short pause f2 medium sou...

Страница 203: ...OP BY OK KEY KEYS LOCKED Sequence A12 long pause A17 CHANGED TO BASE STATE STOP BY CANCELLATION OF FUNCTION Sequence A13 long pause A16 Sound Function INITIAL POINT SUBMENU VALUE Frequency 2820Hz 5 Du...

Страница 204: ...on short vibration 109 375ms 5 MEDIUM VIBRATION Duration medium vibration 203 125ms 5 LONG VIBRATION Duration long vibration 281 25ms 5 Signal Function WARNING AND Reminder REPEATING SEQUENCE Duration...

Страница 205: ...Basal Rate Total Battery Empty Battery Low Beep Volume Bluetooth OFF Icon Meaning Bluetooth ON Bluetooth Settings Bluetooth in Remote control mode Beep Test Cartridge Empty Cartridge Full Cartridge L...

Страница 206: ...e Date Format EU Date Format US Display contrast Extended Bolus Key Lock OFF Icon Meaning Key Lock ON Pump timer Call for update Menu Settings Multiwave Bolus Multiwave Bolus Immediate My Data Pairing...

Страница 207: ...Reminder Settings Reminder Single Display orientation Beep Beep and Vibration Standard Bolus Icon Meaning Stop Total Temporary Basal Rate Therapy Settings Time and Date Settings Units Units per hour V...

Страница 208: ...ethylene oxide Sterilized using irradiation Sterile using aseptic processing techniques Date of manufacture Batch code Icon Meaning Use by Catalogue number Serial number Global Trade Item Number Admi...

Страница 209: ...aning Do not use if the package is damaged Flammable Bluetooth wireless technology Electronic device of type BF according the standard IEC 60601 1 Protection against electrical shock IPX8 Symbol for p...

Страница 210: ...ndustry Canada Identification indicates that the radio frequency equipment has passed the equipment authoriza tion process for Canada Icon Meaning N20091 The compliance mark indicates that the product...

Страница 211: ...ld void your operating warranty for the Accu Chek Spirit Combo insulin pump Please refer to the warranty provisions in your written terms of sale for the Accu Chek Spirit Combo insulin pump and or the...

Страница 212: ...chapter 5 Persona lizing your pump Basal rate This is the amount of insulin delivered per hour that is required to cover your basic insulin needs In insulin pump therapy your basal rate is determined...

Страница 213: ...rtridge The insulin reservoir of your Accu Chek Spirit Combo insulin pump It holds 3 15ml 315U of short acting insulin or fast acting insulin analogue Cartridge compartment The chamber in your Accu Ch...

Страница 214: ...rter than the onset time of regular insulin Insulin regular short acting or fast acting Insulin that has the same chemical structure as insulin produced by the human pancreas The onset time of regular...

Страница 215: ...ch can be accessed while your Accu Chek Spirit Combo insulin pump delivers insulin Your Accu Chek Spirit Combo insulin pump displays the RUN screen during normal use when no programming is being perfo...

Страница 216: ...al rate profile in percentages from 0 500 to match changing insulin needs due to increased or decreased activity level illness or stress U100 This is the insulin concentration Each millilitre of liqui...

Страница 217: ...95 Beep volume 15 57 115 151 172 Blood glucose levels 22 25 41 77 Bluetooth connection 171 Bluetooth function 63 135 136 Bolus 77 Bolus history 81 83 92 106 157 176 Bolus increment 126 Buttons 17 C Ca...

Страница 218: ...delivery starting 55 104 stopping 56 104 K Key Lock 9 18 113 114 191 Keys combining 17 L Language selecting 101 119 Leakage 42 43 59 69 Luer lock connector 43 47 69 70 71 74 179 M Maintaining your pum...

Страница 219: ...5 36 57 turning off 57 Storing your pump 150 Swimming 67 146 Symbols Display Symbols 201 General Symbols 201 T Tactile signals 200 Technical Data 61 175 Temporary Basal Rate 93 94 95 96 97 98 156 157...

Страница 220: ...216 Warnings and Errors 151 confirming 152 handling 140 Warranty 21 207 Wearing your pump carrying systems 61 62 193 in hazardous areas 62 man_05957613001_E_en indb 216 02 03 2015 10 45 05...

Страница 221: ...for alternative insulin therapy options No Error What you have to do E6 MECHANICAL ERROR See chapter 8 E7 ELECTRONIC ERROR See chapter 8 E8 POWER INTERRUPT See chapter 8 E9 END OF OPERATION Arrange f...

Страница 222: ...pump within the scheduled pump operation time No Warning What you have to do W6 TBR CANCELLED Put your Accu Chek Spirit Combo insulin pump into RUN if necessary Ensure the cancella tion was intended...

Страница 223: ...pairing procedure for insulin pump and Meter See section 6 4 Troubleshooting the Bluetooth connection in the User Guide for detailed information Reminder No Reminder What you have to do Reminder Put y...

Страница 224: ...tion This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications Howe...

Страница 225: ...manufacturer importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market N20091 India ETA Certificate No 468 2010 WRLO Singapore Complies with IDA S...

Страница 226: ...222 My notes man_05957613001_E_en indb 222 02 03 2015 10 45 07...

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