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Roche Accu-Check Insight, User Manual

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Roche Accu-Check Insight User Manual Download Page 168

158

* Test levels acc. to IEC/EN 60601-2-24

Immunity test 
standard

IEC 60601 test 
level *

Compliance level

Electromagnetic environment – guidance

Power frequency 
(50 / 60 Hz)
magnetic field
IEC 61000-4-8

400 A/m

400 A/m

Power frequency magnetic fields should be at levels 
characteristic of a typical location in a typical commercial 
or hospital environment.

Summary of Contents for Accu-Check Insight

Page 1: ...rademarks are the property of their respective owners ACCU CHEK ACCU CHEK INSIGHT ACCU CHEK FLEXLINK ACCU CHEK RAPIDLINK and ACCU CHEK TENDERLINK are trademarks of Roche 2011 Roche Roche Diagnostics G...

Page 2: ...your country of residence may only provide support in the corresponding official language s Your insulin pump q Quick Bolus Keys Display Screen x Up Key o OK Key z Down Key l Zoom Key Note If you do n...

Page 3: ...Pump details and accessories Adapter tubing Battery Battery cover Cartridge Pump...

Page 4: ......

Page 5: ...nside back cover Your Accu Chek Insight insulin pump is intended for the subcutaneous continuous delivery of U100 insulin at set and variable rates for the management of diabetes mellitus Whether insu...

Page 6: ...this information may lead to life threatening situations Note A Note contains important information relating to the efficient and smooth operation of your Accu Chek Insight insulin pump Example An Ex...

Page 7: ...hat are part of the basic training lesson It is highly recommended that you read these sections carefully before you start using the pump Sections highlighted in purple refer to features that are part...

Page 8: ......

Page 9: ...eneral safety information 51 4 Administering boluses 53 4 1 Standard Bolus 53 4 2 Quick Bolus 55 4 3 Cancelling a bolus 58 4 4 Extended Bolus 60 4 5 Multiwave Bolus 63 5 Basal profile options 67 5 1 T...

Page 10: ...pump 132 9 4 Maintaining your pump 133 9 5 Storing your pump 134 9 6 Disposing of your pump 135 10 Responding to a pump message 137 10 1 List of Reminders 140 10 2 List of Warnings 142 10 3 List of Ma...

Page 11: ...mode for more than 15 minutes it switches to STOP mode The Pump stopped screen appears and the pump stops completely and cancels all current Temporary Basal Rates and boluses From STOP mode you have...

Page 12: ...against accidental pressing The Key lock disengages your pump s keys so they cannot be pressed accidentally when you wear your pump under clothing The Key lock is engaged by default Quickly press x a...

Page 13: ...with a different daily routine For example you can create one profile for work days and one for weekends See chapter 5 page 67 Basal profile options Use self or pre filled cartridges Your usual insuli...

Page 14: ...ou can adjust as necessary This can be especially helpful when you eat slowly digestible foods or attend long lasting buffets See chapter 4 4 page 60 Extended Bolus 2 options to deliver a Standard Bol...

Page 15: ...y of life situations For example j During meetings your pump can be switched to the Quiet mode At night it can delay non critical Warning messages to a specified wake up time j In Flight mode your pum...

Page 16: ...6 1 1 Navigating through the menus q Quick Bolus Keys Display Screen x Up Key o OK Key z Down Key l Zoom Key...

Page 17: ...Moves to the status screen double click j Stops the repetitive STOP mode warning x j Moves you up in a menu screen j Increases a setting j Function to access quick info screen z j Moves you down in a...

Page 18: ...ighted menu From the Status screen press o The main Menu screen appears 3 The x and z keys move the blue bar cursor up and down in the menu 1 1 1 Navigating through the screens This chapter describes...

Page 19: ...decrease the value 4 6 7 If you need to go back to the previous level and cancel a function press q However when you do this any settings you made will not be saved To confirm a value press the o key...

Page 20: ...equence Wizard numbers in the upper right corner of the screen indicate how many steps still need to be completed In each menu you can use the Home function to return to the Status screen Press z to m...

Page 21: ...in RUN STOP or PAUSE mode and if boluses or Temporary Basal Rates are currently running You can review the complete list of display icons in Appendix D Icons and Symbols page 172 Current time Basal r...

Page 22: ...d colour dark Background colour light Zoom mode With the Background colour dark the screen will show white characters on black background With the Background colour light the screen will show black ch...

Page 23: ...e infusion set s tubing with the adapter to the pump and fill it with insulin j Connect the tubing to the infusion set s head set and fill the head set with insulin prime the infusion set Remember tha...

Page 24: ...have replaced the battery you then have to restart it from the main Menu screen and program any Temporary Basal Rates and boluses again See chapter 3 2 page 39 Your insulin pump settings such as the...

Page 25: ...me begin with step 6 1 2 To avoid accidental insulin delivery ensure that the infusion set is not connected to your body Turn the adapter anti clockwise to a 120 position Push the battery cover releas...

Page 26: ...e battery compartment positive end first negative end pointing out Place the battery cover on top of the battery 7 8 Push the battery cover all the way into the battery compartment until you hear the...

Page 27: ...process after the battery is inserted make sure that the battery is inserted correctly positive end first The first time you insert a battery or after the pump has been without battery for more than...

Page 28: ...rt up process is different when you j Start your pump for the first time j Start your pump after it has been out of power for more than 10 hours j Insert a new battery while the pump is in RUN mode Yo...

Page 29: ...turns black Make sure that the area is completely black 1 2 The display turns red Make sure that the area is completely red The display turns green Make sure that the area is completely green 3 After...

Page 30: ...een appears and the pump emits a series of beeps Make sure you can hear them If this is the first time you have started your pump or if it has been without power for over 10 hours the Setup Wizard gui...

Page 31: ...Press o to go set month 3 The Set hour screen appears Press x or z to set the hour Press o to go set minutes 4 The Set month screen appears Press x or z to set the month Press o to go set day 5 The S...

Page 32: ...ss q to select no Before using your pump you must program at least one basal profile Continue with programming Basal Profile 1 on the next page If there is already a programmed basal profile you can s...

Page 33: ...hanging the End time you can program a varying number of time blocks 1 to 24 with a minimum duration of 15 minuntes and a maximum duration of 24 hours if needed The total of all time blocks is called...

Page 34: ...rs The Start time is always midnight The End of the first time block is highlighted Press x or z to set the time Press o 4 The Program Basal Profile screen appears Press o to select Basal Profile 1 1...

Page 35: ...the second time block is highlighted Continue programming the End time and hourly basal rate for the total of 24 hours 8 After you have programmed an hourly basal rate for all 24 hours press o 10 The...

Page 36: ...e is completely empty your pump sends a Maintenance message M21 Cartridge empty and you must change the cartridge immediately Have the following materials ready j An Accu Chek Insight insulin pump car...

Page 37: ...tically starts rewinding the piston rod Remove the cartridge The Change cartridge screen appears 4 5 Turn the adapter anti clockwise 6 When you reach an angle of about 120 remove the adapter 9 When th...

Page 38: ...e 13 Turn the adapter clockwise all the way to the stop 14 The adapter is correctly positioned when it is aligned with the pump s housing Press o to confirm 15 The Cartridge type screen appears Press...

Page 39: ...efault Continue with the next chapter 16 You are prompted to disconnect the infusion set from your body Press o to confirm Dispose of the used cartridge according to local regulations w WARNING If an...

Page 40: ...ed for filling is not added to the pump s history of daily insulin totals You will learn how to adjust the fill amount in the chapter about Settings See chapter 8 4 3 page 125 2 4 Filling the infusion...

Page 41: ...artridge and tubing If you just inserted a new cartridge start with step 2 In the main Menu press z to move to Cartridge and infusion set Press o to select 1 2 The Cartridge and infusion set menu appe...

Page 42: ...the Cartridge and infusion set menu Fill cannula is selected by default 6 You can now insert the cannula into your body Carefully read and follow the instructions that came with your infusion set You...

Page 43: ...fill amount See chapter 8 4 3 page 125 After filling the tubing your pump switches to the Cartridge and infusion set menu Fill cannula is selected by default Press o to select Fill cannula 1 2 The Fi...

Page 44: ...lly starts to fill the cannula 4 5 When the filling is completed the Start insulin delivery screen appears Press o to select yes Note If you do not want to start the insulin delivery now for any reaso...

Page 45: ...y which could result in under or over delivery of insulin 3 1 1 When and when not to wear your pump There are a few situations where it is recommended that you take off your pump because your pump cou...

Page 46: ...SeeAppendixA TechnicalData page151 for more information about electromagnetic fields Your pump has been tested against and complies with the regulations on electromagnetic interference Security syste...

Page 47: ...inside back cover Note Rapid and extreme changes in air pressure or temperature can influence insulin delivery especially if there are air bubbles in the cartridge or tubing Such changes could occur w...

Page 48: ...ee inside back cover Sport and exercise You can wear your pump while performing a range of sporting activities However it is important that you protect your pump before you begin exercise or sporting...

Page 49: ...ing j There is an occlusion in the infusion set or in the head set j The cannula has slipped out of the infusion site 3 2 Stopping and starting your pump You should discuss with your doctor or healthc...

Page 50: ...o select 3 The Pump stopped screen appears You can now disconnect the infusion set from your body and take off your pump STOP Warning As long as the pump is in STOP mode it will emit a beep every minu...

Page 51: ...free of air bubbles Connect the infusion set to your body according to the instructions that came with it From the Pump stopped screen press o 1 2 The main Menu screen appears Press z to move to Start...

Page 52: ...r pump therapy for more than one day Switch your pump to STOP mode See chapter 3 2 page 39 Disconnect the infusion set from your body 1 2 Remove the adapter cartridge and battery from the pump See cha...

Page 53: ...it is highly recommended that you no longer wear it while swimming bathing or showering When water has entered the cartridge or battery compartment Water may enter into the cartridge compartment thro...

Page 54: ...diately after contact with other liquids or chemicals such as j Cleaning solutions j Drinks j Oil or fat Avoid any contact between the pump and infusion set with health and beauty products for example...

Page 55: ...n set before changing a cartridge or filling the infusion set Otherwise you risk uncontrolled insulin delivery into your body Always follow the instructions for the infusion set and cartridge you are...

Page 56: ...nstructions Change the transfer set adapter and tubing w WARNING Inspect your infusion site at least twice each day for irritation or infection Signs of infection may include but are not limited to pa...

Page 57: ...tridge and connect the adapter Insert the cartridge plunger first into the cartridge compartment 6 7 Replace the adapter on the bayonet socket of the cartridge compartment about 120 angle 9 Turn the a...

Page 58: ...type Press o to select 13 14 The pump then performs a self test See chapter 2 1 page 19 The pump automatically detects the position of the plunger in the cartridge 12 Disconnect the infusion set if no...

Page 59: ...ation about j Current insulin amount in your cartridge and energy status of your battery j Last bolus j Total daily dose of insulin j Last safety event Error Maintenance message or Warning message j C...

Page 60: ...n appears Press z Press x if you want to go back 4 5 The Last message screen appears Press z Press x if you want to go back 6 The Time and date screen appears Press z to return to the Status screen Pr...

Page 61: ...perly 3 6 General safety information w WARNING Do not place your insulin pump in direct sunlight Overheating of the insulin and the pump must be avoided Protect your insulin pump from direct exposure...

Page 62: ...52...

Page 63: ...Bolus 4Administering boluses 4 1 Standard Bolus The Standard Bolus delivers the programmed insulin dose all at once This bolus can be helpful for foods that are digested quickly such as cake or bread...

Page 64: ...h the immediate bolus amount highlighted 5 6 The Bolus to deliver screen appears for 5 seconds If necessary you can press q and program a new bolus amount Press x or z to set the immediate Bolus amoun...

Page 65: ...nct increments The default setting for this increment is 0 5 units which means you can set the bolus amount to 0 5 1 0 1 5 units and so on If needed you can change the increment to 0 1 0 2 1 0 or 2 0...

Page 66: ...he bolus amount highlighted Press the other q key once for each increment until the required bolus amount is reached Each time you press the key your pump beeps and vibrates simultaneously once for ea...

Page 67: ...creen for another 5 seconds 6 Your pump returns to the Status screen showing a progress bar for the remaining bolus amount Note You can cancel the bolus while the Bolus to deliver screen is displayed...

Page 68: ...plays a Warning W38 Bolus cancelled 4 3 Cancelling a bolus 4 3 1 Cancelling a bolus during programming Standard Extended and Multiwave Bolus While programming press q to go back and program a new valu...

Page 69: ...o Cancel Bolus Press o to select 3 4 3 3 Cancelling a bolus using the Cancel Bolus menu 4 The Cancel Bolus screen appears 6 A Warning W38 Bolus cancelled appears Press o to mute the Warning Press o ag...

Page 70: ...s bolus type can be helpful for meals that are slowly digestible for example foods with complex carbohydrates or foods that are high in fat The duration of the bolus delivery can be programmed in 15 m...

Page 71: ...Bolus Press o to select The Extended Bolus screen appears with the delayed bolus amount highlighted Program an Extended Bolus 3 5 6 The bolus duration is highlighted The duration of your last Extende...

Page 72: ...62 Press x or z to set the duration Press o to confirm 7 8 Your pump returns to the Status screen showing a progress bar of the remaining bolus amount and duration in addition to the hourly basal rate...

Page 73: ...s bolus can be helpful when you eat meals that contain both fast and slowly digestible carbohydrates or long meals with several courses You can also use this bolus type when you are planning to eat sl...

Page 74: ...Bolus Press o to select 3 From the Status screen press o 4 The Multiwave Bolus screen appears with the immediate amount field highlighted 5 Press x or z to set the immediate bolus amount Press o Progr...

Page 75: ...e remaining bolus amount and duration of the delayed bolus in addition to the hourly basal rate 10 9 The Bolus to deliver screen appears displaying the insulin units that are still to be delivered for...

Page 76: ...66...

Page 77: ...m changes of your basal insulin requirement like for example when your are ill or when you are playing sports j You can also program additional Basal profiles to meet your insulin need for different d...

Page 78: ...od of time This helps you adjust your basal insulin dose in situations where your insulin need has temporarily changed For example when you are playing sports you might need less insulin and when you...

Page 79: ...Rate 3 From the Status screen press o 4 The Temporary Basal Rate menu appears Press o to select Basic TBR 5 The Basic TBR screen appears with the TBR percentage highlighted Press x or z to set the TB...

Page 80: ...us screen appears showing the percentage and the remaining duration of the TBR in addition to the modified hourly basal rate 7 When the duration of the TBR has expired your pump sends a Reminder R7 TB...

Page 81: ...o select Temporary Basal Rate 3 From the Status screen press o 4 The Temporary Basal Rate menu appears Press z to move to Cancel TBR Press o to select 5 The Cancel TBR screen appears Press o to confir...

Page 82: ...y routines with his doctor Ian Insight programmed Basal Profile 1 for working days He also programmed Basal Profile 2 that provides more basal insulin for Saturdays and Sundays 5 2 Additional Basal pr...

Page 83: ...r z to move to Basal Profile 2 3 4 or 5 Press o to select 1 2 The main Menu appears Press z to move to Basal Press o to select The Basal menu appears Press z to move to Program Basal Profile Press o t...

Page 84: ...s After you have programmed an hourly basal rate for all 24 hours press o 10 The Status screen appears The Basal Profile daily total screen for the Basal Profile 2 3 4 or 5 Make sure the daily total m...

Page 85: ...ches from Basal Profile 1 that is for working days to Basal Profile 2 that matches his weekend habits 5 3 Activating a Basal profile 1 2 The main Menu screen appears Press z to move to Basal Press o t...

Page 86: ...Press x or z to move to Basal Profile 2 1 3 4 or 5 Press o to select The Basal Profile 2 1 3 4 or 5 summary screen appears Make sure you selected the correct profile Press o 5 The Status screen appear...

Page 87: ...9000 pump events Maintenance messages Warnings and Errors programming operations and insulin delivery records This data corresponds to about the last 6 months of use and can be accessed on a personal...

Page 88: ...ata Last 90 boluses Temporary Basal Rate data Last 90 increases and decreases in basal rate Daily insulin totals Last 90 daily totals of insulin delivered Pump timer Remaining time in days until the R...

Page 89: ...data Bolus data TBR data Daily totals Pump timer or Version as needed Press o to select 3 From the Status screen press o The relevant data screen appears starting with the most recent entry Press z t...

Page 90: ...plays j Type and number of the Maintenance message Warning or Error for example Warning W32 j The text of the Maintenance message Warning or Error for example Battery low j Time j Date 6 2 Bolus data...

Page 91: ...ntry Each TBR data screen displays j TBR in percentage j TBR duration j End time j End date 6 4 Daily totals The Daily totals screen allows you to view up to the last 90 daily totals of insulin delive...

Page 92: ...number of remaining days Before the pump timer expires a Warning W39 Loantime Warning will remind you that the operating life of the pump is coming to an end so that you can take appropriate action in...

Page 93: ...refer in most of your everyday life situations Vibrate Set the signal to vibrate only Quiet Set the signal to not disturb for example during meetings Loud Set the signal to be audible in a loud enviro...

Page 94: ...mode 3 From the Status screen press o The Signal mode screen appears Press x or z to move to Normal Vibrate Quiet or Loud Press o to select 4 The pump returns to the Status screen and the new mode is...

Page 95: ...to move to Flight mode Press o to select 3 From the Status screen press o The Flight mode screen appears Press x or z to move to On or Off as needed Press o to select 4 The pump returns to the Status...

Page 96: ...86...

Page 97: ...our diabetes management Communication With the communication settings you can manage the interfaces of your pump to other devices Device settings There are a wide range of options to adapt your pump t...

Page 98: ...Menu screen appears Press z to move to Settings Press o to select The Settings menu appears Press x or z to move to Reminders Communication Device settings Therapy settings or Time and date as needed...

Page 99: ...ill sound each day at the same time You can use the following options Deliver Bolus Reminds you to deliver a bolus at a specified time You can program up to 5 deliver bolus reminders Missed Bolus This...

Page 100: ...the Settings menu press x or z to move to Reminders Press o to select 5 The minutes are highlighted Press x or z to set the minutes Press o 6 The Reminder 1 2 3 4 or 5 Tone screen appears Press x or...

Page 101: ...8 91 The Reminder 1 2 3 4 or 5 Status screen appears Press x or z to move to Off Once or Repeat as needed Press o to select 7 Note When the Reminder goes off press o twice to mute and confirm...

Page 102: ...ess o to select Reminders 5 The minutes are highlighted Press x or z to set the minutes Press o 6 The Infusion set change Tone screen appears Press x or z to move to Tone 1 to 10 as needed Press o Set...

Page 103: ...8 93 The Infusion set change Status screen appears Press x or z to move to Off Once or Repeat as needed Press o to select 7...

Page 104: ...the pump is paired with another device they can exchange data using a stable and secure Bluetooth connection Your pump can be paired with up to 5 other devices in total If you want to pair another dev...

Page 105: ...th on or off in the Communication menu When the Bluetooth function is turned off the airplane icon appears on the Status screen 1 In the Settings menu press z to move to Communication Press o to selec...

Page 106: ...lt the documents accompanying the device the pump is supposed to communicate with Ensure that Bluetooth is switched on before switching Visibility on From the Settings menu press z to move to Communic...

Page 107: ...r pump can be paired with up to 5 other devices in total 1 In the Settings menu press z to move to Communication Press o to select 2 The Communication menu appears Press z to move to Device list Press...

Page 108: ...her as possible It is recommended to do the pairing in a private environment where no other devices are sending Bluetooth or radio signals Also make sure that the batteries are charged Start the pairi...

Page 109: ...evice sends a confirmation to the pump the pump shows the Add device screen Please wait The pump shows the Add device screen while it continues the pairing Please wait The pump shows the Pairing succe...

Page 110: ...100 Note If the pairing was not successful for any reason the pump will show the Connection failed screen Try again preferably in a less crowded environment and with new batteries...

Page 111: ...ou want the pump to be able to communicate with this device you must re do the pairing as described earlier in this chapter See chapter 8 2 4 page 98 1 In the Settings menu press z to move to Communic...

Page 112: ...h your day to day needs You can make adjustments for Mode settings Personalise the settings for Normal Quiet Vibrate and Loud User profile Select Expressive or Diminished Key lock Protect your pump ag...

Page 113: ...d vibrate or both at the same time as an event Warning Reminder Error Maintenance message occurs You can also suspend the signals of Warnings for a specified period of time However since Errors and Ma...

Page 114: ...to select Volume 4 In the Settings menu press z to move to Device settings Press o to select 5 The Volume screen appears Press x or z to select the volume as needed Press o to confirm Adjust the volu...

Page 115: ...n the Settings menu press z to move to Device settings Press o to select 5 The Signal screen appears Press x or z to move to Sound Vibration or Sound and vibration as needed Press o to select Select t...

Page 116: ...n You can suspend the signals of Warnings for all modes for a specified period of time However since Errors and Maintenance messages require your immediate attention you cannot suspend these event sig...

Page 117: ...t as needed Press o to select 7 The Normal Quiet Vibrate or Loud screen appears Press z to move to Signal suspension Press o to select 6 The end time is highlighted Press x or z to set the end time Pr...

Page 118: ...ed eyesight For more information please contact your local pump support see inside back cover In the user profile Diminished all acoustic signals will occur one octave lower This may be helpful if you...

Page 119: ...and z key is pressed unintentionally for example when the pump is under your clothing and an object in your pocket touches a key In this section you will learn to set the time until the keys are lock...

Page 120: ...o Key lock Press o to select The Key lock screen appears Press x or z to change from the current value to the desired number of seconds Press o to confirm Adjust the Key lock In the Settings menu pres...

Page 121: ...e settings menu appears Press z to move to Language Press o to select In the Settings menu press z to move to Device settings Press o to select The Language screen appears Press x or z to move to the...

Page 122: ...nd to help you read the display under different conditions The Device settings menu appears Press z to move to Display Press o to select In the Settings menu press z to move to Device settings Press o...

Page 123: ...z to move to Device settings Press o to select The Display menu appears Press z to move to Orientation Press o to select 4 The Orientation screen appears Press x or z to move to Standard or Rotated as...

Page 124: ...Settings menu press z to move to Device settings Press o to select The Display menu appears Press z to move to Background colour Press o to select The Background colour screen appears Press x or z to...

Page 125: ...rapy settings should be provided by your healthcare professionals and you should discuss with them before making any changes You can adjust the Automatic off Set the time for the Maintenance M23 Autom...

Page 126: ...ired number of hours Press o to confirm 8 4 1 Adjusting the Automatic off function The Automatic off function is a safety feature for emergency situations It will trigger Maintenance message M23 Autom...

Page 127: ...ss o again to confirm Then restart insulin delivery or take other appropriate action When the Maintenance message goes off press o to mute the Maintenance message Note It is highly recommended to chec...

Page 128: ...d to your bolus insulin requirement You can adjust j The Quick Bolus increment j The Delivery speed j The Maximum bolus amount j The Lag setting w WARNING It is vital that you use the correct Quick Bo...

Page 129: ...u appears Press o to select Quick Bolus increment The Quick Bolus increment screen appears Press x or z to set the desired increment Press o to confirm Adjust the Quick Bolus increment The Quick Bolus...

Page 130: ...Adjust the Delivery speed For more convenience during the insulin delivery you can adjust the delivery speed A standard Delivery speed makes the bolus delivery very fast A low Delivery speed can be mo...

Page 131: ...8 121 The Delivery speed screen appears Press x or z to move to Very slow Slow Moderate or Standard as needed Press o to select 4...

Page 132: ...nsulin The Therapy settings menu appears Press z to move to Bolus settings Press o to select In the Settings menu press z to move to Therapy settings Press o to select The Bolus settings menu appears...

Page 133: ...g of the bolus delivery Discuss using the Lag setting with your healthcare team The Therapy settings menu appears Press z to move to Bolus settings Press o to select From the Settings menu press z to...

Page 134: ...a new bolus After programming the bolus amount Standard bolus or the delayed duration Extended or Multiwave bolus the Set lag time screen appears Press x or z to set the lag time Press o to confirm T...

Page 135: ...refer to the infusion set s instructions The Therapy settings menu appears Press z to move to Infusion set settings Press o to select In the Settings menu press z to move to Therapy settings Press o t...

Page 136: ...dge soon You can specify the number of insulin units remaining in your cartridge that will trigger the Warning 1 From the Settings menu press z to move to Therapy settings Press o to select 2 The Ther...

Page 137: ...t the correct amount of insulin at the correct time From the Settings menu press z to move to Time and date Press o to select The Time and date screen appears Press o to select Time The Time screen ap...

Page 138: ...ttings menu press z to move to Time and date Press o to select 3 The Date screen appears with the year field highlighted Press x or z to set the year Press o 4 The month field is highlighted Press x o...

Page 139: ...our time format including a m and p m tag 1 2 The Time and date screen appears Press z to move to Time format Press o to select From the Settings menu press z to move to Time and date Press o to selec...

Page 140: ...130...

Page 141: ...reason you might not be able to hear the beeps or feel the vibrations Accessories Use only Accu Chek Insight sterile products and accessories which are designed to be used with your pump You will find...

Page 142: ...your pump j Check that all the connections in your infusion set are still tight and if they are not reconnect or tighten them j Check your pump and its sterile products and accessories for chips and c...

Page 143: ...g cleaning as this may accidentally change your settings Do not use solvents strong detergents bleaching agents scouring pads or sharp instruments for cleaning as they may damage the pump 9 4 2 Batter...

Page 144: ...t any subsequent malfunction To store your pump place it in STOP mode then j Remove the battery j Remove the cartridge j Insert the battery cover j Store your pump in its packaging Storage conditions...

Page 145: ...r electronic devices If you need to dispose of your insulin pump return it to Roche Diagnostics see inside back cover for professional disposal Cartridge infusion set and accessories For instructions...

Page 146: ...136...

Page 147: ...es and safety information It is vital that you pay attention to these messages and take action as necessary Your pump provides these messages using beeps and vibrations You can turn off either the bee...

Page 148: ...will not stop insulin delivery Maintenance messages A Maintenance message will be triggered when the pump requires your immediate action to maintain its functionality For example when the cartridge i...

Page 149: ...maximum volume the sound volume will rise to the loudest volume level if not confirmed Both the sound and vibration will then continue at maximum level until confirmed Respond to a Reminder Warning M...

Page 150: ...ter 8 1 page 89 Press o to mute Press o to confirm Reminder Deliver Bolus Reminder 1 to 5 Remember to deliver a bolus as appropriate Missed Bolus Reminder 1 to 5 Check whether you missed delivering a...

Page 151: ...10 141 Press o to mute Press o to confirm Reminder TBR completed Reminder The time of a programmed Temporary Basal Rate has expired Check if you need to program a new one...

Page 152: ...me date When the pump has been out of power for more than one hour the time and date may no longer be correct Set the correct time and date See chapter 8 5 page 127 W34 End of warranty The guarantee p...

Page 153: ...A bolus has been cancelled Make sure the cancellation was intended Program a new bolus if appropriate W39 Loantime warning loan pumps only The loan time for your pump will expire soon Contact your lo...

Page 154: ...opriate Press o to mute Press o to confirm Maintenance message M20 Cartridge not inserted Insert a cartridge M21 Cartridge empty There is no insulin left in the cartridge Insert a new cartridge M22 Ba...

Page 155: ...k cover to discuss appropriate action After a Maintenance message M25 the pump will be in STOP mode M26 Cartridge change not completed The cartridge change process was interrupted Repeat the cartridge...

Page 156: ...ssage M29 Battery type not set The battery type was not set during the start up process Set the correct battery type M30 Cartridge type not set The cartridge type was not set during the Change cartrid...

Page 157: ...Press o to mute Press o to confirm Error E6 Mechanical error The mechanical system of the pump does not work properly Change the battery and the cartridge E7 Electronic error When this message occurs...

Page 158: ...Error E13 Language error The pump can no longer show the selected language Change to another language If you cannot select your language and cannot read another available language then contact your lo...

Page 159: ...149 Appendices...

Page 160: ...150...

Page 161: ...ticals all edges rounded Temperature ranges During operation 5 C to 40 C 41 F to 104 F During storage 5 C to 45 C 41 F to 113 F During transport 20 C to 50 C 4 F to 122 F Air humidity During operation...

Page 162: ...n 50 U day using U100 insulin operating temperature 23 C 2 C 73 F 4 F the battery life is approximately Alkaline 1200 mAh 5 days with Bluetooth off Lithium 1200 mAh 14 days with Bluetooth off Data sto...

Page 163: ...ments of 0 05 units The duration of the Extended Bolus and the Multiwave Bolus is adjustable in intervals of 15 minutes up to 24 hours Temporary Basal Rate Adjustable in 10 increments 0 90 for decreas...

Page 164: ...minimum basal rate 0 02 U h 250 h Maximum volume before Maintenance message M24 OCCLUSION Self filled cartridges 1 0 U Pre filled cartridges 2 0 U Maximum pressure 350 kPa 3 5 bar Minimal opening pres...

Page 165: ...occurs in the control system it is identified by the supervising microprocessor and vice versa The motor is immediately switched off and an Error E7 Electronic error occurs The control system and supe...

Page 166: ...environment guidance RF emissions CISPR 11 Group 2 The Accu Chek Insight insulin pump must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affe...

Page 167: ...tic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic mat...

Page 168: ...test level Compliance level Electromagnetic environment guidance Power frequency 50 60 Hz magnetic field IEC 61000 4 8 400 A m 400 A m Power frequency magnetic fields should be at levels characterist...

Page 169: ...Chek Insight 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 le...

Page 170: ...telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF tr...

Page 171: ...ight insulin pump as recommended below according to the maximum output power of the communication equipment Rated maximum output power of transmitter W Separation distance according to frequency of tr...

Page 172: ...ctromagnetic propagation is 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 dec...

Page 173: ...2 420 480 720 900 2 6 5 2000 0 2000 0 3200 0 8909 2 3636 2 7200 1 7960 3 8000 5 6000 1 1579 2 0842 1 4774 1 6581 percentage Error of flow observation window duration min minimum measured variation ma...

Page 174: ...overall percentage Error The measurements were made at the minimum rate of 0 02 U h according to IEC 60601 2 24 1998 with an Accu Chek Insight Adapter and Tubing transfer set 100 cm at room temperatu...

Page 175: ...hek Insight Adapter and Tubing transfer set 100 cm at room temperature The measurements were made according to IEC 60601 2 24 1998 with a Accu Chek Insight Adapter and Tubing transfer set 100 cm at ro...

Page 176: ...es 0 0 02 25 0 U h 0 0 02 25 0 U h Temporary Basal Rate TBR increases or decreases in increments of TBR duration TBR duration increments 100 10 2 h 15 min 0 250 10 15 min 24 h 15 min Basal profiles av...

Page 177: ...in max Bolus 25 U 1 25 0 U Lag time Off Off or On If On 0 to 60 min in 15 min increments Infusion set fill amount 14 0 U 0 25 0 U Cannula fill amount 0 7 U 0 0 2 0 U Display orientation Standard Stand...

Page 178: ...on Normal Volume 3 sound vibration Vibrate Volume 0 vibration Quiet Volume 1 vibration Loud Volume 4 sound vibration Battery type AAA LR03 ALKALINE 1 5V AAA FR03 LITHIUM 1 5V Key lock timeout 30 sec 4...

Page 179: ...ngs Typical range value available on the pump Bluetooth off if delivered with an other Bluetooth enabled device the standard parameter is on off or on Cartridge Warning level 25 U 0 100 U User Profile...

Page 180: ...l Units in context with biological effectiveness of certain insulin amount kPa Kilopascal sec Seconds TBR Temporary Basal Rate U See I U U h Amount of International Units of insulin delivered per hour...

Page 181: ...C 171...

Page 182: ...UN mode Pump running STOP mode Pump stopped PAUSE mode Pump paused Operation successful Connection failed Battery full Battery low Battery empty Icon Meaning Cartridge full Cartridge low Cartridge emp...

Page 183: ...l Rate Activate Basal Profile Temporary Basal Rate TBR Data Program Basal Profile Modes Signal mode Reminder Icon Meaning Cartridge and infusion set menu Change cartridge menu Fill cannula menu Fill t...

Page 184: ...ings Device settings Pump data Pump timer Flight mode Home Duration Please wait Lag time Icon Meaning Total icon Daily totals Time and date settings Software version Maintenance Warning Bluetooth wire...

Page 185: ...D 175 Icon Meaning Radio button selected Radio button not selected Icon on Icon off...

Page 186: ...ons for use Sterilized using ethylene oxide Sterilized using irradiation Batch code Catalogue number Serial number Use by Manufacturer Symbol Meaning Temperature limitation Admissible humidity range A...

Page 187: ...g The FCC ID Federal Communications Commission Identification indicates that the radio frequency equipment has passed the equipment authorization process for the United States of America The IC ID Ind...

Page 188: ...178 Symbol Meaning Warning against device use in electro magnetic or high electrical field or environments...

Page 189: ...E 179 Appendix E Warranty Any changes or modification to the devices not expressly approved by Roche Diagnostics could void your operating warranty for the Accu Chek Insight insulin pump...

Page 190: ...s with impaired hearing Discuss using this user profile with your healthcare professional if you have hearing problems Additionally it is highly recommended that you pay special attention to the vibra...

Page 191: ...or scale DO1 RE1 MI1 FA1 SO1 LA1 TI1 DO2 Tone Frequency Hz 5 DO2 528 RE2 594 MI2 660 FA2 704 SO2 792 LA2 880 TI2 990 DO3 1056 RE3 1188 MI3 1329 Tone Frequency Hz 5 FA3 1408 SO3 1584 LA3 1760 TI3 1980...

Page 192: ...ec after last increment programmed j TBR durations 3 sec after last increment programmed j Basal profile total daily dose when screen is displayed j Quick info screen Time last bolus amount total dail...

Page 193: ...ck info screen time 9 29 From Status screen press x to move to Quick info Wait for the acoustic signal Screen Digit Acoustic code 9 DO3 RE3 MI3 FA3 SO3 LA3 TI3 DO4 RE4 DO 2 DO3 RE3 9 DO3 RE3 MI3 FA3 S...

Page 194: ...184 Program Extended bolus screen bolus amount 6 00 U bolus duration 2 00 h Screen Digit Acoustic code 6 DO3 RE3 MI3 FA3 SO3 LA3 DO 0 DO2 LA2 0 DO3 LA2 2 DO2 RE3 DO 0 DO3 LA2 0 DO3 LA2...

Page 195: ...e and the message number is signaled as described for numeric values Message type Acoustic code Error DO3 SO3 DO3 pause DO3 RE3 MI3 FA3 Maintenance DO3 SO3 DO3 pause DO3 RE3 MI3 Warning DO3 SO3 DO3 pa...

Page 196: ...c code When the message occurs the standard signal for the corresponding message sounds Press o to mute Maintenance DO3 SO3 DO3 pause DO3 RE3 MI3 Then press x to hear the specific message code includi...

Page 197: ...ls has been specially designed to suit your individual needs while wearing your insulin pump Infusion Set Accu Chek Insight Flex infusion set Note For additional Accu Chek products and accessories ava...

Page 198: ...ered by your insulin pump according to the curve of your personal Basal profile or profiles Basal profile Your Accu Chek Insight insulin pump offers you the option of delivering up to 5 different Basa...

Page 199: ...Cartridge compartment The chamber in your insulin pump for the cartridge Daily insulin total The total amount of insulin basal rate plus boluses delivered in a 24 hour period beginning at midnight Th...

Page 200: ...y Insulin is produced in the beta cells of the pancreas also called islets of Langerhans Insulin analogue rapid acting A type of insulin created using recombinant DNA technology The onset time of insu...

Page 201: ...ife situations By default you can adjust the modes for Normal Vibrate Quiet and Loud Occlusion An occlusion is a blockage which prevents the insulin from flowing correctly from the insulin pump into t...

Page 202: ...ou about the status of your pump and recent therapy events Rapid acting insulin analogue See Insulin analogue rapid acting Regular insulin short acting See Insulin regular short acting Reminder You ca...

Page 203: ...the screen Additionally a progress bar indicates when a Bolus or TBR is currently running STOP When your insulin pump is in STOP mode it does not deliver any insulin The insulin delivery is only stopp...

Page 204: ...contains 100 International Units of insulin Your insulin pump has been developed exclusively for delivery of U100 short acting regular human insulin or rapid acting insulin analogue Warning A Warning...

Page 205: ...195...

Page 206: ...80 Display 2 102 112 E Error 80 137 147 Event data 80 Event history 77 80 Expressive 108 180 Extended Bolus 4 60 Index A Acoustically impaired 108 Activating basal profile 75 Alarm clock 5 Auto key lo...

Page 207: ...ing cartridge 26 K Key lock 2 18 102 109 Keys 6 L Lag setting 4 123 Lag time 4 123 Language 102 111 Leakage 3 M Maintenance 80 137 144 Menus 6 Modes 83 103 104 106 Mode settings 102 Multiwave Bolus 5...

Page 208: ...108 Volume 104 W Warning 80 137 142 Wizard 1 Q Quick Bolus 55 Quick Bolus increment 119 Quick info 49 R Remaining time 82 Reminder 5 89 92 137 140 S Self test 18 19 Set Lag time 124 Setting date 127 1...

Page 209: ...a residential installation 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 rad...

Page 210: ...e product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer importer or their agent responsible for compliance and for placing it on the...

Page 211: ...201...

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