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Technical Data

16.6 Delivery Rate Accuracy

It is the responsibility of the healthcare professional to decide
whether the accuracy of the delivery rate is adequate for the
patient in question. The delivery accuracy does not depend on
the length of the cannula used.

The measurements were carried out according to
IEC 60601-2-24 under the following conditions:

Description

Value

Unit

Temperature

21 ± 6

°C

Relative humidity

50 ± 30

%

Atmospheric pressure

1013 ± 50

hPa

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Summary of Contents for Accu-Chek Solo

Page 1: ...User s Manual Accu Chek Solo micropump system man_07866364001_C_en UK indb 1 12 10 2018 13 07 31 ...

Page 2: ...man_07866364001_C_en UK indb 2 12 10 2018 13 07 31 ...

Page 3: ...abetes manager If the diabetes manager does not work recharge the battery using the supplied charger or connect the USB cable to a PC For more information refer to the printed User s Manual of the micropump system or the Internet at www accu chek com From this website you can download the User s Manual as a PDF file To contact the Customer Support and Service Centre UK Accu Chek Pump Careline1 UK ...

Page 4: ... quick bolus increment The quick bolus increment is set to 0 2 U by factory default The quick bolus increment I have set is U You can change the quick bolus increment here Main menu Settings Bolus settings 1 Press and hold both quick bolus buttons for approximately 3 seconds 2 Simultaneously press both quick bolus buttons repeatedly until the desired insulin amount is reached Check the number of t...

Page 5: ...man_07866364001_C_en UK indb 5 12 10 2018 13 07 32 ...

Page 6: ...emarks owned by Bluetooth SIG Inc and any use of such marks by Roche is under license Teflon is a registered trademark of E I du Pont de Nemours and Company or its affiliates All other product names and trademarks are the property of their respective owners 2018 Roche Diabetes Care Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim Germany www accu chek com 07866364001 C Last update 201...

Page 7: ...rmation Screen 22 2 5 Navigation and Operation 23 3 Putting the Diabetes Manager into Operation 33 3 1 Charging the Battery 33 3 2 Setup Wizard 39 3 3 Programming a Basal Rate Profile 52 4 Putting the Micropump into Operation 57 4 1 Overview 57 4 2 Recommended Infusion Sites 61 4 3 Putting the Components into Operation 62 4 4 Stopping and Starting the Micropump 83 5 Testing or Entering Your Blood ...

Page 8: ...185 9 1 Starting the Replacement 186 9 2 Replacing the Infusion Assembly 187 9 3 Replacing the Reservoir 190 9 4 Replacing the Pump Base 193 10 My Data 195 10 1 Overview 195 10 2 Logbook 195 10 3 Trend Graph 203 10 4 Standard Week 208 10 5 Target Range 211 10 6 BG Averages Table 214 10 7 System Events 216 10 8 Data Transfer 219 11 Changing Settings 221 11 1 Warning Limits 222 11 2 Time and Date 22...

Page 9: ...ing 313 16 Technical Data 319 16 1 Micropump System 319 16 2 Diabetes Manager 321 16 3 Micropump 324 16 4 Infusion Assembly 328 16 5 Insertion Device 329 16 6 Delivery Rate Accuracy 330 17 Symbols Abbreviations Signals 335 17 1 Symbols 335 17 2 Abbreviations 338 17 3 Signals 340 18 Appendix 343 18 1 Guarantee 343 18 2 Licence Information 343 18 3 Declaration of Conformity Radio Equipment Directive...

Page 10: ...teristics of the system components in order to be able to use the micropump system properly and reliably This User s Manual is intended for people with diabetes their caregivers for parents whose children have diabetes as well as for healthcare professionals This User s Manual is your first source of information for the micropump system or in case of any problems using it If you have any questions...

Page 11: ... To help you fully benefit from the micropump system a distinction between basic and advanced is made with regard to the various features and properties Chapters highlighted in blue refer to features that are required to be able to use the micropump system Read these chapters before using the Accu Chek Solo micropump system Chapters highlighted in purple refer to features that are recommended for ...

Page 12: ...ables and accessories from Roche Not included but necessary for using the micropump system j j Accu Chek Solo reservoir assembly j j Accu Chek Solo infusion assembly consisting of Accu Chek Solo cannula assembly and Accu Chek Solo pump holder j j Accu Chek Aviva test strips and Accu Chek Aviva control solution Pump base Diabetes manager Note j j Order a new pump base in time before the operating l...

Page 13: ... exact insulin type for treating your diabetes mellitus will be prescribed by your healthcare professional Consult the manufacturer s package insert 1 1 Intended Use The Accu Chek Solo micropump system is a prescription medical device intended for the subcutaneous continuous delivery of rapid acting U100 insulin with variable delivery quantities and for the quantitative determination of blood gluc...

Page 14: ...are not able or willing to perform at least 4 blood glucose tests per day j j People who are not able to be in regular contact with their healthcare professional j j People who do not understand what is required for insulin pump therapy or who are not able to follow the instructions for use of the micropump system j j People who cannot be relied upon due to drug addiction substance abuse or mental...

Page 15: ...onitor the functions of the micropump regularly In case of improper use of the micropump system or non compliance with your healthcare professional s instructions you risk experiencing for example hypoglycaemia hyperglycaemia ketoacidosis or infections of the infusion site Follow the treatment plan you agreed on with your healthcare professional as well as the setting for basal rate profiles and b...

Page 16: ...ot change your therapy without consulting your healthcare professional first w WARNING j j Check your blood glucose level at least four times a day j j Check your blood glucose level more than four times a day if your insulin sensitivity is high j j If the micropump has been subjected to mechanical shocks check your blood glucose level at least once within 1 to 3 hours j j Keep all parts of the mi...

Page 17: ...Maintain a distance of at least 30 cm between the micropump system and portable HF communication devices Portable and mobile HF communication devices may impair the micropump and the diabetes manager Note Before starting the insulin pump therapy find out where and how you can obtain alternative therapy supplies for example a blood glucose meter or pen at short notice in case the micropump system d...

Page 18: ... Accu Chek Solo pump base is part of the micropump It contains the mechanical parts as well as the electronics to control and monitor the operation of the pump 1 5 Components of the Micropump System The Accu Chek Solo micropump system is a system that primarily consists of a tubeless micropump and a diabetes manager which serves as a remote control The interactive displays on the diabetes manager ...

Page 19: ...annula It creates a connection between the micropump and the body The Accu Chek Solo cannula assembly is available with cannula lengths of 6 mm orange or 9 mm blue Accu Chek Solo pump holder The Accu Chek Solo pump holder is an adhesive pad that is adhered to the skin to fix the cannula in place It also holds the micropump in place Accu Chek Solo insertion device The Accu Chek Solo insertion devic...

Page 20: ... system events by means of the information screen j j Adjustable user menus in several languages Customised bolus and basal features j j Bolus delivery up to 50 U with diabetes manager or programmable directly on the micropump j j Selectable bolus types standard extended multiwave j j Basal rates from 0 1 U per hour up to 25 U per hour j j 5 basal rate profiles for different daily routines j j Tem...

Page 21: ...betes manager j j Optional entry of blood glucose results that were measured with other blood glucose meters j j Illumination for test strip slot and test strip j j Rechargeable battery in the diabetes manager j j Optional key lock with PIN j j Programmable volume setting and vibration mode for different environments j j Built in self tests and automatic detection of malfunctions j j Information b...

Page 22: ... 1 7 Using the Micropump System in Daily Life The micropump system is intended to be used continuously every day in any everyday situation There are only a few situations in which it is necessary to pay special attention to the system or remove the micropump in order to protect it Use the micropump system only if it is functioning properly and does not show any signs of damage Always have alternat...

Page 23: ...luence insulin delivery especially if there are air bubbles in the reservoir Such changes may occur for example when you are on an aeroplane especially during take off and landing or if you engage in a sport such as hang gliding In such cases do the following Remove any air bubbles from the reservoir and test your blood glucose at frequent intervals If in doubt remove the micropump and change to a...

Page 24: ...icropump and diabetes manager For wireless communication between the micropump and the diabetes manager it is not necessary for the devices to be right next to each other Obstacles such as walls or furniture between the pump and the diabetes manager can reduce or interrupt the communication range When communication is interrupted a message is displayed on the screen For more information see chapte...

Page 25: ...he micropump using Bluetooth wireless technology It transmits commands to and receives data from the micropump and saves the data for insulin delivery in the electronic logbook Note j j Always have the diabetes manager with you j j A rechargeable battery supplies power to the diabetes manager Charge the battery on a regular basis j j If the environment you are in has a high noise level or if the d...

Page 26: ...4 1 2 5 A B C 6 8 9 7 3 14 Getting to Know the Micropump System man_07866364001_C_en UK indb 14 12 10 2018 13 07 36 ...

Page 27: ...tons for operating context sensitive functions 8 Navigation buttons Navigation controls for moving between menus and process steps 9 Insulin button Button for confirming a previously set insulin delivery 10 Test strip slot For inserting test strips for blood glucose tests and control tests 11 Camera Used to scan the pairing code on the pump base to pair the micropump and the diabetes manager 12 Ba...

Page 28: ...se result basal rate ongoing boluses and reservoir level at a glance You can access other information and menus from the Status screen Depending on the situation for example whether you are using pump therapy or injection therapy other content and symbols will be displayed 16 Getting to Know the Micropump System man_07866364001_C_en UK indb 16 12 10 2018 13 07 36 ...

Page 29: ...ctive bolus type and the remaining insulin units 4 New bolus Tap New bolus or to program a new bolus 5 Main menu Tap this button to display the main menu 6 Reservoir level Shows how many insulin units are in the reservoir 7 Remaining bolus time Shows the amount of time remaining of an extended or multiwave bolus 8 Bolus progress bar Shows the amount and duration of the active bolus in the form of ...

Page 30: ... quickly access important menus and features When you tap the areas the corresponding menus or features are opened Basal rate menu Replace system components menu Cancel bolus Bolus menu Logbook entries menu 18 Getting to Know the Micropump System man_07866364001_C_en UK indb 18 12 10 2018 13 07 36 ...

Page 31: ...ery 2 Menu icons Tap a menu icon to open the desired menu or to turn on the desired feature 3 Add data Tap this button to add further data to the logbook for example blood glucose result or time of test 4 Status screen Tap this button to display the Status screen Depending on the situation for example pump therapy or injection therapy other menus can be displayed For more information see chapter 1...

Page 32: ...ion Is displayed when communication between the diabetes manager and the micropump is interrupted Flight mode Is displayed when flight mode is turned on No acoustic signal Is displayed when tones are turned off Signals turned off Is displayed when signals for reminders and warnings are turned off temporarily Vibration Is displayed when the vibration feature is turned on 20 Getting to Know the Micr...

Page 33: ...TBR and interrupt basal rate Test blood glucose enter test result perform control test Replace system components infusion assembly reservoir pump base Menu icon Description View or change settings view system information switch therapy mode Display or edit logbook data Connect diabetes manager to a PC in order to transfer data Turn flight mode on or off Set signals Watch Help videos 2 21 Main Menu...

Page 34: ...ide your finger from the upper screen edge downwards The information screen is shown Move the information screen to the top again to hide it If you slide the upper screen edge downwards the information screen is shown The bar on the sliding pane lights up blue while it is being moved Event data Bolus data TBR data Logbook entries Total daily dose Sliding pane 22 Getting to Know the Micropump Syste...

Page 35: ...ove forwards and backwards or to go to the Status screen Button Function Back Go back to the previous display within the process step If you press the Back button in a process step the settings will not be saved Status screen Switch to the Status screen Forward Go to the next display within the process step In many process steps this button performs the same function as the Next or OK buttons In s...

Page 36: ...of making entries in order to execute commands select values set features and select display elements The various entry methods are explained on the following pages Check whether the settings for insulin delivery are correct Press the button to start insulin delivery If the displayed insulin amount is not correct tap in order to correct your entries 24 Getting to Know the Micropump System man_0786...

Page 37: ...Switching a feature on or off By tapping a switch you can turn a feature on or off Inactive function buttons and switches are greyed out Tap the switch to turn the feature on Tapping the same switch again turns the feature off Tap the element you want to select The background changes from dark to light 2 25 Navigation and Operation man_07866364001_C_en UK indb 25 12 10 2018 13 07 39 ...

Page 38: ...u have selected an element the next display appears Simple lists or menus No element is preselected in simple lists or menus You can select an element Tap the element you want to select A green tick is displayed in the checkbox If you tap the element once more the tick disappears and the element is no longer selected 26 Getting to Know the Micropump System man_07866364001_C_en UK indb 26 12 10 201...

Page 39: ...lists one element is always selected for example by the factory settings By tapping the desired element you can change the selection Editing an element To edit the desired element it must be selected Tap the element you want to edit You can edit the element on the display that follows 2 27 Navigation and Operation man_07866364001_C_en UK indb 27 12 10 2018 13 07 40 ...

Page 40: ... list elements or menus Move the slider to the desired position Scrolling lists In long menus and lists you can scroll the list to display the elements that are not visible Slider You can make the desired setting by moving the slider 28 Getting to Know the Micropump System man_07866364001_C_en UK indb 28 12 10 2018 13 07 42 ...

Page 41: ...ing the numeric keypad Display field for entry 2 5 4 Entering Numbers You can either use a numeric keypad to enter numbers or use the minus plus buttons to set them Some numbers and values can only be set using the minus plus buttons or only be entered by means of the numeric keypad Back arrow Deletes the entered data one character at a time 2 29 Navigation and Operation man_07866364001_C_en UK in...

Page 42: ...lue on the display Keep your finger on one of the minus plus buttons for a bit longer to decrease or increase the numeric values in a fast scroll mode Button to decrease the value entered Symbol for entering text using the minus plus buttons Button to increase the value entered Display field for entry Minus plus buttons and allow you to switch between entering data using the minus plus buttons and...

Page 43: ... reservoir level and the basal rate are displayed even when the screen is locked You unlock the screen by swiping your finger from the middle of the screen in any direction If you have activated PIN entry you will have to enter the four to eight digit PIN on the next display to unlock the diabetes manager screen You have the option of changing the settings in the menu Settings Screen lock Unlockin...

Page 44: ...32 Getting to Know the Micropump System man_07866364001_C_en UK indb 32 12 10 2018 13 07 43 ...

Page 45: ...ireless technology to save power As a result communication with the micropump is interrupted After you have recharged the battery the diabetes manager automatically restores communication via Bluetooth wireless technology Symbols for different battery levels low 20 40 60 80 100 Note j j While the diabetes manager is being charged you cannot perform any blood glucose tests j j Recharge the battery ...

Page 46: ...espective symbols in the battery compartment 2 Open the battery compartment by pushing the battery door up in the direction of the arrow 3 1 1 Inserting the Rechargeable Battery in the Diabetes Manager w WARNING j j Use only the supplied charger and the associated USB cable or a certified USB charger for example a laptop certified according to IEC 60950 or an equivalent safety standard j j Use onl...

Page 47: ...SB cable into the USB socket of the diabetes manager Plug the charger into a wall socket the images show a 2 pin plug but you will use a 3 pin plug 3 1 2 Charging the Battery Using a Wall Socket 4 Close the battery compartment by pushing the battery door in the direction of the arrow until it clicks into place man_07866364001_C_en UK indb 35 12 10 2018 13 07 46 ...

Page 48: ...s j j Disconnect the charger from the diabetes manager j j Wait for a short time j j Reconnect the charger to the diabetes manager j j If the problem cannot be resolved using the suggested solutions contact your Customer Support and Service Centre 4 The Status screen or Main menu displays the symbol in the status bar It indicates that the battery is being charged To end the charging process first ...

Page 49: ...t on your computer The USB charging port is often indicated by a lightning bolt symbol 3 1 3 Charging the Battery Using a Computer 3 The Status screen or Main menu displays the symbol in the status bar It indicates that the battery is being charged To end the charging process first remove the USB cable from the diabetes manager and then from the PC man_07866364001_C_en UK indb 37 12 10 2018 13 07 ...

Page 50: ...dels the computer must not be in sleep or standby mode if you want to charge the battery j j If the battery level of the diabetes manager is very low the screen is black at first j j If you want to transfer data to the computer via the USB cable follow the instructions in chapter 10 8 Data Transfer man_07866364001_C_en UK indb 38 12 10 2018 13 07 47 ...

Page 51: ... your healthcare professional j j Wrong basal rate settings may lead to hyperglycaemia or hypoglycaemia j j Having the time and date set precisely is essential in order for your micropump system to function properly Having the wrong time set may result in the delivery of incorrect insulin amounts thus leading to hyperglycaemia or hypoglycaemia The data and settings you enter are cached at specific...

Page 52: ...ages Tap Save Setting the language 1 2 Press and hold the power button on the top of the diabetes manager until the diabetes manager turns on If the diabetes manager is turned on Briefly press the power button to activate the energy saving standby mode The diabetes manager vibrates issues the Start signal sequence and the signal LED lights up The start display appears briefly For more information ...

Page 53: ... manager with a PIN unlock code You can find the label with the 8 digit PIN unlock code on the back cover of the User s Manual Selecting Setup mode 1 Tap Manual setup and continue with the section Setting the time and date Note It is not currently possible to perform the setup on the PC man_07866364001_C_en UK indb 41 12 10 2018 13 07 48 ...

Page 54: ...played or entered in the following format HH MM HH hours MM minutes 24 hour time format 01 07 16 15 HH MM 12 hour time format 01 07 am 04 15 pm HH MM am or pm Time period 02 35 2 hours and 35 minutes The date is always displayed or entered in the format DD MMM YYYY DD day MMM month YYYY year for example 29 Mar 2018 man_07866364001_C_en UK indb 42 12 10 2018 13 07 48 ...

Page 55: ...p Wizard 3 4 Tap Time The hours field is selected dark background Use and to set the hours 6 5 Tap Date Tap the minutes field Use and to set the minutes Tap OK man_07866364001_C_en UK indb 43 12 10 2018 13 07 49 ...

Page 56: ... day field is highlighted Use and to set the day Tap the month field Use and to set the month Tap the year field Use and to set the year Tap OK 10 Once you have entered all settings for time and date tap OK man_07866364001_C_en UK indb 44 12 10 2018 13 07 50 ...

Page 57: ...m BE Broteinheit bread equivalent 12 grams KE Kohlenhydrateinheit carbohydrate unit 10 grams CC Carbohydrate choice 15 grams Setting the carbohydrate unit Note You cannot change the selected carbohydrate unit in the diabetes manager later on 2 Tap Yes if the correct unit is displayed If you want to change the unit tap No You then return to Step 1 man_07866364001_C_en UK indb 45 12 10 2018 13 07 51...

Page 58: ...warning limits tap Done Setting warning limits You can set warning limits for hyperglycaemia and hypoglycaemia that best fit your needs Whenever your blood glucose result is above the hyper warning limit or below the hypo warning limit the diabetes manager displays a warning 2 Use and to set the upper warning limit Tap OK man_07866364001_C_en UK indb 46 12 10 2018 13 07 52 ...

Page 59: ... In chapter 7 2 Setting Up Bolus Advice you will find the explanations and steps for setting up this feature If you do not want to set up bolus advice now tap No 6 Note If you do not want to set up bolus advice now the setup wizard skips the steps for setting up bolus advice You can set up bolus advice at a later time man_07866364001_C_en UK indb 47 12 10 2018 13 07 53 ...

Page 60: ...ime The diabetes manager allows you to define blood glucose target ranges for certain times of day For this purpose the day is divided into time blocks By dividing the day into time blocks you can adjust the blood glucose target range to your specific needs man_07866364001_C_en UK indb 48 12 10 2018 13 07 53 ...

Page 61: ...3 49 Setup Wizard 3 5 4 Use and to set the start time Tap OK Tap Done Use and to set the end time Tap OK 6 Tap Upper limit value man_07866364001_C_en UK indb 49 12 10 2018 13 07 54 ...

Page 62: ...he Diabetes Manager into Operation 8 7 9 Tap Lower limit value Use and to set the upper limit value Tap OK Use and to set the lower limit value Tap OK 10 Tap Done man_07866364001_C_en UK indb 50 12 10 2018 13 07 55 ...

Page 63: ...ed time blocks tap Done Note You can set one blood glucose target range for all time blocks or different ones for the various time blocks The settings for the first time block are used in all copied time blocks Tap the appropriate time blocks to change these settings 13 Tap OK man_07866364001_C_en UK indb 51 12 10 2018 13 07 56 ...

Page 64: ...the basal insulin requirement over up to 24 time blocks results in the basal rate profile To put the micropump into operation and begin therapy you must program at least one basal rate profile Insulin delivery U h Hourly basal rate Time Example Basal rate profile Tap OK to set up a basal rate profile The button is deactivated 1 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 man_0...

Page 65: ...2 3 Define the end time for the first time block To do so tap the top entry field in the End column 4 Note The first time block always starts at 00 00 The last time block always ends at 00 00 The factory settings provide 24 time blocks with one hour each A time block can range from 15 minutes to a maximum of 24 hours All time blocks have a basal rate of 0 U h set by factory default man_07866364001...

Page 66: ... end time of a time block shortens or overwrites the next time block this display appears Tap Yes 6 8 Define the insulin units per hour for the first time block To do so tap the top entry field in the U h column 7 Use and to set the end time for the first time block Tap OK 5 man_07866364001_C_en UK indb 54 12 10 2018 13 07 58 ...

Page 67: ...wards to display all time blocks If you want to view the basal rate profile as a graph tap the symbol Once you have set all time blocks tap Done 9 Next you have to prepare the micropump For more information see chapter 4 Putting the Micropump into Operation Tap OK to confirm 10 man_07866364001_C_en UK indb 55 12 10 2018 13 07 58 ...

Page 68: ...56 Putting the Diabetes Manager into Operation man_07866364001_C_en UK indb 56 12 10 2018 13 07 58 ...

Page 69: ...tant or sterile alcohol wipe The following steps are necessary to put the micropump into operation j j Use the insertion device to attach the pump holder to the body and insert the cannula j j Fill the new reservoir with insulin j j Connect the reservoir to the pump base j j Pair the micropump with the diabetes manager j j Fill the reservoir needle j j Attach the micropump to the pump holder j j S...

Page 70: ...Adhesive pad Reservoir needle Protective film for battery Piston rod Opening for safety release of the insertion device Cannula opening with cannula support Soft Teflon cannula Introducer needle Handle Cannula casing Flap for detaching the micropump Reservoir assembly Infusion assembly man_07866364001_C_en UK indb 58 12 10 2018 13 08 00 ...

Page 71: ... Cannula opening Detach button Safety release Pairing code Pump base with reservoir mounted Pump shield Opening for ventilation Lock Cannula assembly slot Recess for attaching the pump holder Recess for attaching the pump holder Insertion device Micropump man_07866364001_C_en UK indb 59 12 10 2018 13 08 01 ...

Page 72: ... infusion assembly immediately There is a risk that infections for example hepatitis or HIV could be transmitted j j If there is an unexpected rise in your blood glucose level or an occlusion message occurs check the micropump and the infusion assembly for occlusions and leaks Replace your infusion assembly if you are not sure whether the infusion assembly is working properly j j Check regularly t...

Page 73: ...issue are the most suitable For example Infusion site Characteristics Abdominal region Common infusion site with good insulin absorption Upper arm Slower insulin absorption compared to the abdominal region Thigh Slower insulin absorption compared to the abdominal region Hip lower back buttocks Slower insulin absorption compared to the abdominal region Also suitable for physically active users or i...

Page 74: ...marks and moles tattoos injuries bruises or rashes j j Before you attach the pump holder to the body the infusion site must be completely dry j j A new infusion site must be at least 5 cm away from the last infusion site j j To avoid injury and infection never touch the introducer needle or the cannula j j If the pump holder frequently becomes detached from the skin consult your healthcare profess...

Page 75: ... given by your healthcare professional Make sure that the infusion site is dry and free from residues Attach the hook on the pump holder to the underside of the insertion device Press the pump holder onto the underside of the insertion device until it locks into place Check whether the pump holder is correctly locked into place 4 3 1 Attaching the Infusion Assembly to the Body man_07866364001_C_en...

Page 76: ...bly is in the correct position 5 Prime the insertion device by rotating the priming handle clockwise in the direction of the arrow as far as it will go When the insertion device is fully primed you will hear a click 180 8 Remove both parts of the protective film from the adhesive pad Do not touch the adhesive surface of the adhesive pad This could impair the adhesive properties man_07866364001_C_e...

Page 77: ...tton to insert the cannula under the skin 11 Smooth over the adhesive pad around the infusion assembly so that the infusion assembly is in good contact with the skin 12 Press the detach button and detach the insertion device from the infusion assembly If possible keep the adhesive pad in position with the other hand man_07866364001_C_en UK indb 65 12 10 2018 13 08 07 ...

Page 78: ...Check whether the grey cannula head in the cannula opening is visible and flush with the opening If this is not the case repeat Steps 1 to 16 using a new pump holder and a new cannula assembly 15 Remove the used cannula casing from the insertion device 16 Dispose of the used cannula casing according to local regulations man_07866364001_C_en UK indb 66 12 10 2018 13 08 08 ...

Page 79: ... cannula assembly in the insertion device j j Never store the insertion device in a primed state Storing the insertion device incorrectly may weaken the spring tension which will impair the operation of the insertion device j j Check at regular intervals whether the micropump system has visible or tangible signs of damage This applies in particular if the system components were dropped or were exp...

Page 80: ...reservoir immediately after filling it j j Occlusions may occur if the temperature of the insulin or micropump system is too low j j During filling make sure you remove any air bubbles from the reservoir 4 3 2 Filling the Reservoir with Insulin w WARNING j j Only use the micropump to deliver rapid acting U100 insulin j j If you connect an empty reservoir to the micropump for example for training p...

Page 81: ... firmly and pull it downwards in the direction of the arrow in order to fill the reservoir with air Fill the reservoir with the volume of air that you later want to fill with insulin Carefully pull out the battery s protective film downwards in the direction of the arrow to activate the battery 2 Remove the new reservoir assembly from the packaging man_07866364001_C_en UK indb 69 12 10 2018 13 08 ...

Page 82: ...voir 5 Place the insulin vial on a flat and solid surface for example a table top and hold it firmly Place the filling aid onto the vial Push the filling aid downwards until you hear it click into place Note j j The reservoir must be filled with at least 80 U j j The reservoir has a maximum holding capacity of 200 U 2 0 ml j j Take care not to touch the reservoir needle You might injure yourself m...

Page 83: ...om the reservoir Slowly pull the handle downwards in the direction of the arrow 2 until the reservoir is filled with the required amount of insulin again Slowly pull the handle downwards in the direction of the arrow to fill the reservoir with insulin Try to ensure that no air bubbles form in the reservoir 1 2 8 Note Check the reservoir from several angles to make sure that there are no air bubble...

Page 84: ...of the arrow Dispose of the filling aid according to local regulations 12 Compress the handle on the ribbed surface 1 and then remove the handle laterally from the piston rod 2 Dispose of the handle 2 1 w WARNING During disposal ensure that no third party could injure themselves man_07866364001_C_en UK indb 72 12 10 2018 13 08 14 ...

Page 85: ...d check whether the battery is activated and repeat Steps 2 to 4 1 2 3 4 3 3 Connecting the Reservoir to the Pump Base Remove the blue reservoir cap from the pump base Align the piston rod of the filled reservoir such that you can insert it into the piston rod opening of the pump base Push the filled reservoir onto the pump base until both parts are tightly connected man_07866364001_C_en UK indb 7...

Page 86: ... default setting for when the reservoir is filled the next time Tap Save Note j j Make sure that there is no gap between the reservoir and the pump base j j Do not exert too much force when connecting the pump base to the reservoir j j Make sure that the opening for ventilation of the micropump is always clear so that the battery is fully functional j j For more information on the sequences of sig...

Page 87: ...he back of the diabetes manager and the pairing code on the pump base to pair the devices If this is not possible you can enter the pump key into the diabetes manager If several micropumps are within the communication range of the diabetes manager you must select the micropump serial number from a list that is displayed 4 3 4 Pairing the Diabetes Manager and Micropump Note Each pump base can only ...

Page 88: ...ring code The diabetes manager establishes the radio connection to the micropump Wait a moment Point the camera of the diabetes manager at the pairing code on the pump base Hold the diabetes manager in such a way that the pairing code can be read in full A signal sounds if the pairing code was detected and a prompt to fill the reservoir needle is displayed man_07866364001_C_en UK indb 76 12 10 201...

Page 89: ...r micropump 1 If no signal sounds the pairing code was not detected Tap to return to the Detect micropump display Tap Enter pump key Entering the pump key manually 3 Tap Enter here and enter the pump key using the keyboard If pairing was successful a signal sounds Tap Done man_07866364001_C_en UK indb 77 12 10 2018 13 08 18 ...

Page 90: ...xt to the symbol Pump key example GW00000254 00000254 GW00000255 00000255 Pump base 1 and 2 1 The micropump is now ready to fill the reservoir needle and displays a message to this effect Tap Fill 4 3 5 Filling the Reservoir Needle w WARNING Never fill the reservoir needle while it is connected to an infusion assembly attached to your body There is a risk of uncontrolled insulin delivery man_07866...

Page 91: ...e needle tap Cancel Note j j If you do not see a drop of insulin at the tip of the needle after a maximum of 2 minutes there is still too much air in the reservoir If no insulin drop is visible even after refilling you must use a new reservoir j j If you tap Cancel or do not enter any data an information message is displayed after 2 minutes saying that filling failed You can then replace the reser...

Page 92: ...mp system can become leaky 4 3 6 Attaching the Micropump To properly attach the micropump to the pump holder the recess for attaching the micropump needs to be clicked onto the hook on the pump holder w WARNING Check the micropump and the pump holder for damage before you attach the micropump to the pump holder Deformations or cracks can cause the micropump system to become leaky This can lead to ...

Page 93: ...r insulin delivery 4 Tap Next A small amount of insulin is delivered in order to fill the soft Teflon cannula 2 1 Using pressure on the pump shield press the micropump onto the pump holder until there is a clearly audible CLICK Fit the recess on the micropump onto the hook on the pump holder man_07866364001_C_en UK indb 81 12 10 2018 13 08 21 ...

Page 94: ... steps for using the micropump for the first time you can activate the set basal rate profile Once you have activated the basal rate profile the micropump system setup is complete The basal rate is delivered and you can use other system features Follow the settings for basal rate profiles you agreed on with your healthcare professional For more information see chapter 8 Basal Rate Profiles and Tem...

Page 95: ...care professional 4 4 Stopping and Starting the Micropump Stopping insulin delivery Note If insulin delivery is interrupted check your blood glucose level If needed deliver the missing insulin using a syringe or pen for example when j j You stop or remove the pump for a longer period of time j j There is a technical problem with the pump j j There is an occlusion in the cannula infusion assembly j...

Page 96: ... of signals see chapter 17 3 Signals w WARNING Should you be unable to stop the micropump for any reason remove the micropump from the infusion assembly or pull the infusion assembly s adhesive pad together with the micropump off your skin Note Stopping the micropump cancels all ongoing boluses and the Temporary Basal Rate or In the next step you are prompted to activate the basal rate profile Aft...

Page 97: ...r a test strip a finger pricker and a lancet drum j j Set up the diabetes manager before testing your blood glucose for the first time j j Read the test strip package insert In the package insert you will find further important information on storage accuracy and precision of test results and possible causes of incorrect test results Mannheim Germany mmol L Diabetes manager Note j j The unit of me...

Page 98: ...puncture site with warm water and soap and rinse them well j j The diabetes manager is only intended for blood glucose testing with fresh capillary blood from the fingertip Note j j You cannot perform a blood glucose test while the diabetes manager is being charged j j When the diabetes manager prompts you to apply a drop you have approximately 2 minutes to apply blood to the test strip If you do ...

Page 99: ...rection of the arrow The device turns on automatically and the LED at the test strip slot lights up If the tone for blood glucose tests is turned on a signal sounds The Apply drop display appears The test strip is ready for testing Inserting the test strip 3 Wash your hands with warm water and soap and rinse them well Dry your hands thoroughly with a clean towel before obtaining blood Prior to the...

Page 100: ...s manager j j Remove the test strip in case of a test strip error and repeat the blood glucose test using a new test strip j j Only apply blood to the test strip when the test strip is in the test strip slot and Apply drop is displayed j j When a test strip is in the diabetes manager the touchscreen and the buttons including the power button are deactivated The buttons are activated again when you...

Page 101: ...se tests is turned on a signal sounds Tap OK The blood glucose test starts when enough blood has been drawn up by the test strip Applying blood Displaying the test result Note j j For more information about blood glucose results see chapter 5 1 4 Evaluating Test Results j j The blood glucose result can be used for bolus advice for a period of 15 minutes man_07866364001_C_en UK indb 89 12 10 2018 1...

Page 102: ...without adding any information or delivering a bolus tap Done If you want to deliver a bolus tap Bolus once you have completed all the necessary information Remove the used test strip and dispose of it according to local regulations 11 Note j j You can subsequently change the added information in the My data menu j j If bolus advice has been calculated based on information you added about health e...

Page 103: ... the bolus advice feature also see the information in chapter 7 Bolus Advice w WARNING Incorrect entries for carbohydrate amounts or health events may lead to incorrect bolus advice Tap Time of test Entering the time of test You can assign exactly one time of test to each blood glucose test This information may be helpful later on for determining patterns in your blood glucose level man_0786636400...

Page 104: ...bol Tap Save Tap Carbohydrates Entering carbohydrates 2 Tap the desired time of test for example Before meal Tap Save If you test your blood glucose in connection with a meal it is advisable to save the carbohydrate amount you wish to eat If you are using bolus advice the entered carbohydrate amount is used to calculate the insulin amounts you need man_07866364001_C_en UK indb 92 12 10 2018 13 08 ...

Page 105: ...s If you have set up bolus advice and select a health event bolus advice will be adjusted by the percentage you specified Discuss health event adjustments with your healthcare professional who will help you to determine the suitable percentage for the adjustment 7 If you have selected more than one 1 health event enter the total percentage for the selected health events Tap Save man_07866364001_C_...

Page 106: ...Level 8 9 In the Test result in detail menu tap Note Entering a note Type a note to save with this entry Tap Done You can enter a personal note max 280 characters to save with the test result man_07866364001_C_en UK indb 94 12 10 2018 13 08 28 ...

Page 107: ...ulin injection mode Injection mode allows you to save the amounts of basal insulin you injected in the diabetes manager This is done most easily when you test your blood glucose Note that the basal insulin you specify does not have any influence on bolus advice calculation For more information on injection mode see chapter 13 Injection Therapy Mode man_07866364001_C_en UK indb 95 12 10 2018 13 08 ...

Page 108: ...package insert w WARNING j j If your blood glucose value is very high test for ketones If the test returns a positive result and you are experiencing symptoms of ketoacidosis for example headache and vomiting contact a healthcare professional or accident and emergency unit immediately j j If the test result does not match how you feel test your blood glucose again to rule out an incorrect test res...

Page 109: ...t range Yellow below your target range but above your hypo warning limit Red Hypo below the hypo warning limit Eat a sufficient amount of fast acting carbohydrates immediately Being aware of the symptoms of low or high blood glucose can help you to better understand your test results and decide what to do Symptoms of low blood glucose may include j j Anxiety shakiness j j Sweating headache j j Inc...

Page 110: ...ot exceed the hyper warning limit Green Blue If the blood glucose result exceeds the hyper warning limit the diabetes manager will issue the W 75 warning before displaying the test result Follow the warning instructions and confirm the warning with OK to go to the blood glucose result Blue dot with the additional information Hyper The blood glucose result exceeds the hyper warning limit Blue with ...

Page 111: ...s below the hypo warning limit the diabetes manager will issue the W 80 warning before displaying the test result This warning does not show the blood glucose result Follow the warning instructions and confirm the warning with OK to go to the blood glucose result Red dot with the additional information Hypo The blood glucose result falls below the hypo warning limit Red man_07866364001_C_en UK ind...

Page 112: ...od glucose and again within the next half hour j j If hypoglycaemia persists consume additional carbohydrates and consult your healthcare professional LO display 5 1 6 LO Display The LO display means that the blood glucose result is outside the value range Note The LO display means that your blood glucose value might be very low Being aware of the symptoms of low blood glucose can help you to bett...

Page 113: ...h blood glucose can help you to better understand your test results and decide what to do The blood glucose result is above the measuring range of the diabetes manager If you are experiencing any of the common symptoms of high blood glucose proceed as follows j j Test your blood glucose again and test ketones j j Follow the instructions of your healthcare professional HI display man_07866364001_C_...

Page 114: ...e correct temperature range j j Did you use the test strip immediately after removing it from the test strip container j j Are the test strips still valid see the label on the test strip container next to the e symbol j j Did you observe the storage conditions for the diabetes manager and the test strips j j Was the cap on the test strip container always closed tightly j j Did you observe the sour...

Page 115: ... you do not want to test your blood glucose with the diabetes manager you can manually enter a blood glucose value that was measured using another meter on the screen intended for that purpose 1 In the Main menu tap Test 2 Tap No man_07866364001_C_en UK indb 103 12 10 2018 13 08 29 ...

Page 116: ...If you want to add information Time of test Carbohydrates Health events Note to the entered blood glucose value follow the instructions in the section Adding Information on the previous pages If you want to complete entering the blood glucose value without adding any information or delivering a bolus tap Done If you want to deliver a bolus tap Bolus once you have completed all the necessary inform...

Page 117: ...calculation according to the specifications of your healthcare professional 6 1 Manual Bolus Delivery You can deliver a bolus manually or by means of the bolus advice feature This chapter explains manual bolus delivery with different bolus types Moreover it describes the options to cancel bolus delivery 6Delivering a Bolus Note When you test your blood glucose and deliver a bolus keep in mind that...

Page 118: ...lus advice is activated the amount of active insulin that is to be considered is displayed If there is no active insulin is displayed Total amount In this entry field you can enter the total amount for the bolus The total amount is the sum of correction bolus and meal bolus Bolus type Tap this element to select one of the following bolus types Standard bolus extended bolus multiwave bolus quick bo...

Page 119: ...deactivated If you increase the total amount the value for the correction bolus is increased accordingly The correction bolus is always delivered as a standard bolus or as an immediate amount of a multiwave bolus If you reduce the total amount the value for the meal bolus is reduced if one exists Once the meal bolus reaches the value 0 the correction bolus is reduced accordingly 6 3 Bolus Types Yo...

Page 120: ...a buffet Multiwave bolus A multiwave bolus combines a standard bolus with an extended bolus A part of the bolus amount is delivered immediately whereas the other part is delivered over a programmable period of time Use this bolus for meals that contain both fast and slowly digestible carbohydrates proteins and fats You can also use this bolus for meals that extend over a longer period of time If y...

Page 121: ... Option 2 On the Status screen tap New bolus or the symbol Test result Bolus Option 1 After testing your blood glucose On the Test result in detail display tap Bolus Continue with Step 3 or or You can program a bolus in different ways Start with one of the following three options man_07866364001_C_en UK indb 109 12 10 2018 13 08 31 ...

Page 122: ...to your situation to enter the correction bolus meal bolus or total amount Use and to set the desired amount for the meal bolus Tap OK Use and to set the desired amount for the correction bolus Tap OK 2 Tap Manual bolus man_07866364001_C_en UK indb 110 12 10 2018 13 08 32 ...

Page 123: ...bolus type is set as the default in the factory settings Tap Bolus Check the total amount displayed To confirm this step and deliver the bolus press the insulin button lit up in green below the diabetes manager screen 6 4 1 Standard Bolus Note You can add an extended bolus to an ongoing standard bolus man_07866364001_C_en UK indb 111 12 10 2018 13 08 32 ...

Page 124: ...hout bolus delivery the Status screen shows the remaining time and remaining amount of the extended bolus The extended bolus must not be used to correct blood glucose values Therefore you cannot select this bolus type if the bolus you programmed contains correction insulin 1 2 Tap Type on the Bolus input display Tap Extended bolus Then tap OK 3 Tap Duration man_07866364001_C_en UK indb 112 12 10 2...

Page 125: ... is delivered the next time 4 5 6 Use and to set the hours and minutes for the extended bolus duration Tap OK Check the total amount and duration displayed To confirm this step and deliver the bolus press the insulin button lit up in green below the diabetes manager screen Tap Bolus man_07866364001_C_en UK indb 113 12 10 2018 13 08 34 ...

Page 126: ...e extended bolus The Status screen is displayed with the current bolus information Note You can add a standard bolus to an ongoing extended bolus and an additional extended bolus or a multiwave bolus man_07866364001_C_en UK indb 114 12 10 2018 13 08 34 ...

Page 127: ... possible to select a multiwave bolus if a meal bolus has been programmed The immediate amount of the bolus cannot be set to a value less than the correction bolus The minimum insulin amounts for the immediate amount and the delayed amount are 0 1 U respectively 3 Tap Immediate amount to enter the bolus part that is to be delivered immediately Alternatively you can tap Delayed amount to enter the ...

Page 128: ...e immediate amount or the delayed amount the other amount will be adjusted automatically since the total amount is known Tap Duration 6 Use and to set the duration of the delayed amount Tap OK Note The duration you set for the extended bolus will be used as the default setting when the multiwave bolus is delivered the next time man_07866364001_C_en UK indb 116 12 10 2018 13 08 35 ...

Page 129: ...t up in green below the diabetes manager screen The micropump delivers the multiwave bolus The Status screen is displayed with the current bolus information Note You can add an extended bolus to an ongoing multiwave bolus As soon as the immediate part of a multiwave bolus was delivered you can add a standard bolus or another multiwave bolus man_07866364001_C_en UK indb 117 12 10 2018 13 08 36 ...

Page 130: ...o on If necessary you can change the quick bolus increment to 0 5 U 1 0 U or 2 0 U For more information see chapter 11 3 Bolus Settings Note j j Fill in the increment you set for the quick bolus on the detachable quick reference instructions supplied in the cover page of this User s Manual j j The bolus advice feature initially treats quick boluses as correction insulin Mark the quick boluses in t...

Page 131: ...ds without pressing the quick bolus buttons 3 4 The micropump issues a Quick bolus increment tone for each programmed quick bolus increment Check whether the acoustic feedback for the quick bolus increments corresponds to the desired insulin amount If the acoustic feedback corresponds to the desired insulin amount and you want to deliver the quick bolus press both quick bolus buttons simultaneousl...

Page 132: ...well as future bolus advice calculations might not be correct j j For more information on the sequences of signals see chapter 17 3 Signals Example You want to deliver a quick bolus with 2 5 U j j With a quick bolus increment of 0 5 U you have to press the quick bolus buttons 5 times to deliver an insulin amount of 2 5 U j j Wait approx 3 seconds to complete the input j j Check the acoustic feedba...

Page 133: ... want to deliver a bolus with a pen or syringe you can document the insulin amounts delivered on the Bolus input display The insulin amounts you documented will be saved in the diabetes manager The entered insulin amounts are taken into account for future bolus advice calculations This improves the result of further bolus advice calculations 3 Tap the desired entry field If you tap Total amount th...

Page 134: ...o set the insulin amount you want to deliver using a pen or syringe Tap OK If the total amount to be delivered is correct tap OK Tap Bolus 7 Inject the insulin units with a pen or syringe man_07866364001_C_en UK indb 122 12 10 2018 13 08 39 ...

Page 135: ...s that has already been completely delivered the M 77 maintenance message will be displayed If you cancel several boluses the M 77 maintenance message will only be displayed for the ongoing boluses For all boluses that were fully delivered no maintenance message is displayed You can view the fully delivered bolus amount in the My data menu w WARNING Should you be unable to stop the micropump for a...

Page 136: ... The bolus has been cancelled and deleted from the Status screen 3 If you want to cancel the bolus now tap Yes 4 The W 38 warning is displayed Tap OK to confirm the warning man_07866364001_C_en UK indb 124 12 10 2018 13 08 40 ...

Page 137: ...or in the Main menu tap the option with the symbol Tap Cancel all boluses 6 7 2 Cancelling All Boluses 3 Tap Yes 4 For each cancelled bolus the W 38 warning is displayed Tap OK to confirm the warning man_07866364001_C_en UK indb 125 12 10 2018 13 08 41 ...

Page 138: ...126 Delivering a Bolus 5 All boluses have been cancelled and deleted from the Status screen man_07866364001_C_en UK indb 126 12 10 2018 13 08 41 ...

Page 139: ...to specify an interval between programming a bolus and the actual start of bolus delivery Discuss using the delivery lag time setting with your healthcare professional If you want to make use of the delivery lag time you must activate this feature in the Bolus settings menu first For more information see chapter 11 3 Bolus Settings Note If a bolus contains correction insulin or if the blood glucos...

Page 140: ...5 or 60 minutes Tap OK Tap Bolus 5 6 To confirm this step and deliver the bolus press the insulin button lit up in green below the diabetes manager screen The Status screen is displayed with the current bolus information and the set delivery lag time man_07866364001_C_en UK indb 128 12 10 2018 13 08 42 ...

Page 141: ...ue and a meal bolus is recommended at the same time a negative correction bolus lowers the total insulin amount of the bolus advice If your blood glucose value is below the hypo warning limit no bolus advice is issued Instead you receive a recommendation to consume a certain carbohydrate amount to bring your blood glucose level back to within the target range Advantages of bolus advice j j Bolus a...

Page 142: ...n as the target value Insulin sensitivity The insulin sensitivity defines the insulin amount required to lower your blood glucose level by a certain value Carbohydrate ratio The carbohydrate ratio defines the insulin amount necessary to compensate for a certain amount of ingested carbohydrates Note the following Insulin that was not delivered via the micropump system can only be taken into account...

Page 143: ...which no increase in the blood glucose level is to be tolerated after a meal Acting time The acting time is the period of time from the start of bolus delivery until the blood glucose level is expected to return to the target level The acting time includes the offset time Offset time The offset time is the period of time after which the insulin is expected to start lowering the blood glucose level...

Page 144: ...ime blocks add up to a time period of 24 hours The diabetes manager factory settings contain 5 default time blocks You can set up a maximum of 8 time blocks The bolus advice feature uses the time blocks that you have already set while executing the setup wizard If required you can change the time block settings w WARNING Discuss intended changes to your bolus advice options with your healthcare pr...

Page 145: ...art time If you want to keep the start and end times tap Done The button is deactivated Use and to set the start time for the first time block You can set the minutes in 15 minute increments Tap OK Use and to set the end time for the first time block You can set the minutes in 15 minute increments Tap OK Defining a time block man_07866364001_C_en UK indb 133 12 10 2018 13 08 44 ...

Page 146: ...target range Tap Upper limit value If you do not want to modify the limit values for the target range tap Next Use and to set the lower limit value Tap OK The limit values currently set for the target range are displayed Tap Next man_07866364001_C_en UK indb 134 12 10 2018 13 08 46 ...

Page 147: ...ult settings display remains deactivated grey until the entries for Carbohydrate ratio and Insulin sensitivity are complete Example Carbohydrate ratio 1 00 U 10 g In this example one insulin unit compensates for 10 g of carbohydrates Use and to set the insulin units for the carbohydrate ratio Tap OK Use and to set the carbohydrate amount for the carbohydrate ratio Tap OK man_07866364001_C_en UK in...

Page 148: ...Tap OK Tap Done Use and to set the blood glucose value for the insulin sensitivity Tap OK Insulin sensitivity Example Insulin sensitivity 1 00 U 2 2 mmol L In this example one insulin unit lowers the blood glucose value by 2 2 mmol L man_07866364001_C_en UK indb 136 12 10 2018 13 08 48 ...

Page 149: ...hange the start time for the first time block only Changes to the target range carbohydrate ratio and insulin sensitivity can be made for each time block Tap the time block you want to change If you do not want to change the copied settings for the other time blocks tap Done Continue with section Setting a health event Tap End time Changing time block settings man_07866364001_C_en UK indb 137 12 1...

Page 150: ...he end time for the selected time block Tap OK Tap Next Tap Done when you have completed the desired settings for all time blocks 5 Set the upper and lower limit values Tap Next man_07866364001_C_en UK indb 138 12 10 2018 13 08 51 ...

Page 151: ...health events and 3 customised health events j j Exercise 1 j j Exercise 2 j j Stress j j Illness j j Premenstrual j j Customised Name 1 3 You can also enter health events at a later time The percentage for a health event must be between 50 and 50 You can change the percentage in increments of 5 Setting health events Example You like running so you create the customised health event Run with a per...

Page 152: ...the customised health event for example Run If you want to set a customised health event tap Enter a percentage for the selected health event Tap Save Repeat Steps 1 and 2 to set the percentage for other health events Setting a customised health event Setting a health event man_07866364001_C_en UK indb 140 12 10 2018 13 08 53 ...

Page 153: ...t Tap Save 1 Tap Meal rise Snack size Acting time and Offset time to adjust the respective settings Bolus advice options Note The Done button on the Bolus advice options display remains deactivated grey until you make a numeric entry for the snack size man_07866364001_C_en UK indb 141 12 10 2018 13 08 54 ...

Page 154: ...l rise Snack size Use and to set the meal rise value Tap OK 4 5 Use and to set the hours and minutes for the acting time Tap OK Acting time Offset time Use and to set the hours and minutes for the offset time Tap OK man_07866364001_C_en UK indb 142 12 10 2018 13 08 55 ...

Page 155: ...143 Setting Up Bolus Advice 7 6 7 All settings for calculating bolus advice are now complete Tap OK Tap Done to complete the setup wizard man_07866364001_C_en UK indb 143 12 10 2018 13 08 56 ...

Page 156: ...tions This section describes how to change the values for meal rise snack size acting time and offset time 1 2 Tap Bolus advice options Tap the respective entries to set the meal rise snack size acting time and offset time Tap Done after making changes to all the settings man_07866364001_C_en UK indb 144 12 10 2018 13 08 57 ...

Page 157: ...ess 3 Enter a percentage for the selected health event Tap Save Repeat Steps 2 and 3 to set the percentage for other health events 7 3 2 Changing Percentages for Health Events 4 The health events are displayed with the percentages that were set Tap Done after setting the health events man_07866364001_C_en UK indb 145 12 10 2018 13 08 58 ...

Page 158: ...ry to change the end times and other information for the remaining time blocks until all of the time blocks are set up the way you want them 3 7 3 3 Deleting a Single Time Block Tap the time block to be deleted In this example the time block from 11 30 to 15 30 is to be deleted 1 2 In the Main menu tap the Settings menu Tap Time blocks man_07866364001_C_en UK indb 146 12 10 2018 13 08 59 ...

Page 159: ... and lower limit value for the new time block Tap Next 6 7 It may be necessary to adjust the end times and settings of the remaining time blocks Once you have finished editing the time blocks tap Done Set the carbohydrate ratio and insulin sensitivity for the new time block Tap Done man_07866364001_C_en UK indb 147 12 10 2018 13 09 00 ...

Page 160: ...merged with one or more time blocks In this example the three time blocks between 08 30 and 22 00 are being merged You can delete one or more time blocks by merging different time blocks 1 2 In the Main menu tap the Settings menu Tap Time blocks man_07866364001_C_en UK indb 148 12 10 2018 13 09 01 ...

Page 161: ...e upper limit value and lower limit value for the merged time block Tap Next It may be necessary to adjust the end times and settings of the remaining time blocks Tap Done when you have finished editing the time blocks Set the carbohydrate ratio and insulin sensitivity for the merged time block Tap Done man_07866364001_C_en UK indb 149 12 10 2018 13 09 03 ...

Page 162: ...menu Tap Time blocks This section describes how to add a new time block To add a time block decrease the end time of the last time block After the new time block has been created you may have to adjust the end time and other information for each time block man_07866364001_C_en UK indb 150 12 10 2018 13 09 03 ...

Page 163: ... this will delete the time block Tap Next 5 Set the upper limit value and lower limit value for the new time block Tap Next 6 7 Set the carbohydrate ratio and insulin sensitivity for the new time block Tap Done It may be necessary to change the end times and settings of other time blocks Tap Done when you have finished editing the time blocks man_07866364001_C_en UK indb 151 12 10 2018 13 09 05 ...

Page 164: ...me and end time for the first time block Tap Done This section describes how to restore the settings for all time blocks to the factory settings and then re enter them Changing the start time of the first time block for example may be one reason for resetting all time blocks man_07866364001_C_en UK indb 152 12 10 2018 13 09 06 ...

Page 165: ...ime being Tap Done 5 6 7 Tap OK Set the carbohydrate ratio and the insulin sensitivity that are to be used for all time blocks for the time being Tap Done It may be necessary to change the end times and settings of the other time blocks Tap Done when you have finished editing the time blocks man_07866364001_C_en UK indb 153 12 10 2018 13 09 07 ...

Page 166: ... if you enter it in the diabetes manager In doing so consider the following j j Boluses for which bolus advice was used are indicated by the symbol in the logbook If no bolus advice is set up bolus advice is turned off or a manual bolus was delivered the symbol is displayed j j If you deliver a quick bolus the information on the total bolus amount is taken into account for future bolus advice Howe...

Page 167: ... entry fields if you want to change the suggested values Tap Bolus 2 If you have selected multiple health events enter the total percentage Tap Save Note You can select a maximum of 4 health events If you have selected more than one health event you will have to enter a total percentage for the selected health events in the next step Discuss health event adjustments with your healthcare profession...

Page 168: ...amount the correction bolus is increased accordingly If you decrease the total amount the meal bolus is decreased accordingly Once the meal bolus reaches 0 the correction bolus is decreased accordingly 4 Tap Type to select the desired bolus type Tap Bolus Selecting the bolus type Changing bolus advice values Note Not every bolus type can be selected depending on the setting You cannot select an ex...

Page 169: ...s screen is displayed showing the current bolus information To confirm this step and deliver the bolus press the insulin button lit up in green below the diabetes manager screen Confirming the bolus man_07866364001_C_en UK indb 157 12 10 2018 13 09 09 ...

Page 170: ...us advice 1 You can enter your blood glucose value that was measured using another meter and the carbohydrate amount you want to eat If you then tap Bolus on the Bolus advice display a bolus advice is shown Note We recommend using the built in meter of the diabetes manager to rule out transfer errors of entered test results man_07866364001_C_en UK indb 158 12 10 2018 13 09 10 ...

Page 171: ...lt using the numeric keypad and tap OK Alternatively you can set the test result using or To do so tap the symbol The entered test result is displayed Tap OK if the test result is correct Confirming the test result 3 Tap the field for manually entering the blood glucose result man_07866364001_C_en UK indb 159 12 10 2018 13 09 11 ...

Page 172: ...u want to eat Alternatively you can enter the carbohydrate amount using the numeric keypad To do so tap the symbol Tap Save 9 If necessary enter any health events Tap Bolus 10 Once all entries are correct tap Bolus Entering carbohydrates man_07866364001_C_en UK indb 160 12 10 2018 13 09 13 ...

Page 173: ...ing Bolus Advice Without a BG Result If you do not want to test or enter your blood glucose you can enter the carbohydrate amount you wish to eat If you then tap Bolus on the Bolus advice display a suggestion for a meal bolus is displayed On the Status screen tap New bolus or the symbol In the Main menu tap the Bolus menu or 1 man_07866364001_C_en UK indb 161 12 10 2018 13 09 13 ...

Page 174: ...s 4 Use or to set the carbohydrate amount you want to eat Alternatively you can enter the carbohydrate amount using the numeric keypad To do so tap the symbol Tap Save 5 Tap Bolus Entering carbohydrates man_07866364001_C_en UK indb 162 12 10 2018 13 09 15 ...

Page 175: ... without performing a blood glucose test 7 Once all entries are correct tap Bolus 8 To confirm this step and deliver the bolus press the insulin button lit up in green below the diabetes manager screen man_07866364001_C_en UK indb 163 12 10 2018 13 09 15 ...

Page 176: ...ure that the insulin amount saved by the micropump system is identical to the amount you delivered Also consult the instructions for use for your insulin pen or syringe 1 2 Start bolus advice with or without testing your blood glucose Tap Type Tap Pen syringe man_07866364001_C_en UK indb 164 12 10 2018 13 09 16 ...

Page 177: ... to the system that you are delivering this insulin amount The bolus advice feature will take the corresponding insulin amount into account in the next calculations The Status screen is displayed Inject the insulin units you confirmed with a pen or syringe man_07866364001_C_en UK indb 165 12 10 2018 13 09 17 ...

Page 178: ... turn off bolus advice all bolus advice options will be deleted If you want to use bolus advice again you must set it up once again Tap Bolus advice Tap Yes if you want to turn off bolus advice now The bolus advice options will be deleted 7 5 Turning Off Bolus Advice man_07866364001_C_en UK indb 166 12 10 2018 13 09 18 ...

Page 179: ...iffer on certain weekdays on weekends during illness or on holiday you can create and use different basal rate profiles You can program up to 5 basal rate profiles in the diabetes manager Basal rate profiles are defined through time blocks Each time block needs a start time and an end time as well as an hourly basal rate which is specified in insulin units per hour U h w WARNING Wrong basal rate s...

Page 180: ...fferent ways Start by using one of the following two options 2 In the Basal rate menu tap Basal rate profiles In the Main menu tap the Basal rate menu On the Status screen tap the area indicating the basal rate or 1 8 2 Creating and Editing a Basal Rate Profile man_07866364001_C_en UK indb 168 12 10 2018 13 09 19 ...

Page 181: ...he system shows 24 time blocks of 1 hour each j j You are only able to edit the end times of basal rate time blocks The start time of each time block is identical to the end time of the previous time block j j To add a new time block set the end time of the last time block to the desired start time of the new time block j j To delete a time block decrease the end time of the time block to equal th...

Page 182: ...ulin amount 4 6 Use and to set the end time for the time block Tap OK Use and to set the basal rate for the time block for example 1 50 U h Tap OK 5 When the end time of a time block shortens or overwrites the next time block this display appears Tap Yes man_07866364001_C_en UK indb 170 12 10 2018 13 09 20 ...

Page 183: ...fined by your healthcare professional Note If the total amount displayed does not correspond to the total amount defined by your healthcare professional check all the time blocks and correct the entries For more information see chapter 8 2 3 Changing a Basal Rate Profile 7 Repeat this process until the correct basal rate has been programmed for all 24 hours of the day Tap Save man_07866364001_C_en...

Page 184: ...e profile you want to activate for example Profile 2 The currently active basal rate profile is indicated by the symbol 2 If required scroll the display upwards to check all time blocks of the basal rate profile Once all settings are correct tap Activate 3 While a basal rate profile is being activated insulin delivery is interrupted Note that ongoing boluses are also interrupted Tap Yes man_078663...

Page 185: ...ivation of the selected basal rate profile and takes you to the previous display The basal rate profile that was previously active remains active 5 The activated basal rate profile is displayed on the Status screen Profile 2 man_07866364001_C_en UK indb 173 12 10 2018 13 09 21 ...

Page 186: ...l rate profile Tap an end time to change the end time for the time block Tap a basal rate to change the basal rate for the time block 3 Repeat this process until the correct basal rate has been programmed for all 24 hours of the day Tap Save 4 The changed basal rate profile is displayed in the overview of existing basal rate profiles Check whether the total amount displayed corresponds to the tota...

Page 187: ...te that the active basal rate profile cannot be deleted The active basal rate profile is indicated by the symbol 2 3 4 The selected basal rate profile was deleted from the list of available basal rate profiles Tap the symbol in the upper right corner of the screen Tap Yes to delete the basal rate profile man_07866364001_C_en UK indb 175 12 10 2018 13 09 23 ...

Page 188: ...tivate a Temporary Basal Rate of less than 100 in addition to a low basal rate this may be less than the minimum possible output amount of the micropump TBR Settings range Decrease 0 90 Increase 110 250 The percentage and the duration of a TBR are saved Each time a Temporary Basal Rate is selected the last used settings are displayed Note j j A TBR cannot be programmed if the micropump is in STOP ...

Page 189: ...a TBR In the Main menu tap the Basal rate menu On the Status screen tap the area indicating the basal rate or A temporary basal rate can be programmed edited and deleted in different ways Start by using one of the following two options man_07866364001_C_en UK indb 177 12 10 2018 13 09 24 ...

Page 190: ...ge for adjusting the Temporary Basal Rate Tap Save Tap Percentage to enter the percentage of the temporary basal rate 4 Tap Duration to enter the running time for the temporary basal rate 1 Tap Standard TBR 8 4 1 Programming a TBR man_07866364001_C_en UK indb 178 12 10 2018 13 09 24 ...

Page 191: ...he TBR if the percentage is less than or greater than 100 for example 90 or 110 Tapping cancels the activation and takes you to the previous display 6 Tap Activate 7 To confirm this step and start the standard TBR press the insulin button lit up in green below the diabetes manager screen man_07866364001_C_en UK indb 179 12 10 2018 13 09 25 ...

Page 192: ...s For a customised TBR the percentage and the duration are saved These settings are used as default values each time you select this TBR You also have the option of entering a name for a customised TBR Example You go running for 1 hour twice a week You know that your body needs 25 less insulin during this activity and the subsequent recovery phase of 2 hours You program a TBR of 75 for 3 hours 1 T...

Page 193: ...Run The name may have up to 12 characters Tap Done 3 Tap Percentage to enter the percentage for the customised TBR 4 Use and to set the percentage for adjusting the customised TBR Tap Save 5 Tap Duration to enter the running time for the customised TBR man_07866364001_C_en UK indb 181 12 10 2018 13 09 26 ...

Page 194: ...ustomised TBR Tap OK 7 8 To save your settings for the customised TBR without starting it tap Save The newly programmed customised TBR is displayed Note A customised TBR less than 100 is indicated by this symbol A TBR greater than 100 is indicated by this symbol man_07866364001_C_en UK indb 182 12 10 2018 13 09 27 ...

Page 195: ...p the desired entry in the list of Temporary Basal Rates 8 4 3 Activating a Customised TBR 3 To confirm this step and start the TBR press the insulin button lit up in green below the diabetes manager screen 4 The activated TBR is displayed on the Status screen man_07866364001_C_en UK indb 183 12 10 2018 13 09 28 ...

Page 196: ...g a TBR 2 Tap Yes 1 Tap Cancel TBR 3 The percentage and the duration of the TBR so far are displayed in the W 36 warning Tap OK to confirm the warning 4 The TBR has been cancelled and deleted from the Status screen man_07866364001_C_en UK indb 184 12 10 2018 13 09 28 ...

Page 197: ...r is 4 days It may last longer than this depending on your usage pattern and the insulin amount needed daily j j Replace the system components in the early morning Do not replace the system components before longer sleeping phases j j You will find animated videos on replacing system components and operating the micropump system in the Main menu of the diabetes manager under the Help menu item j j...

Page 198: ...rvoir symbol or In the Main menu tap the Replace menu or 9 1 Starting the Replacement Note Always use the diabetes manager to start the process of replacing one or more system components This is the only way that the micropump system will be able to give you a timely reminder to replace a component man_07866364001_C_en UK indb 186 12 10 2018 13 09 29 ...

Page 199: ...ssembly 1 2 Tap Replace The micropump switches to STOP mode and issues the Cancel signal sequence The display for selecting the system components appears Tap Infusion assembly Note j j Check the pulled out cannula to ensure that it has been completely removed j j If you dampen the infusion assembly with warm water or apply an oily ointment it becomes easier to pull off the adhesive pad man_0786636...

Page 200: ...ges of the adhesive pad and pulling it off to the centre Removing the used infusion assembly 5 6 If you want to see a video on how to replace the infusion assembly tap Help Tap Done when you have finished the action step shown on the screen Dispose of the used infusion assembly according to local regulations Tap Done man_07866364001_C_en UK indb 188 12 10 2018 13 09 30 ...

Page 201: ...ally To confirm this step and then restart the micropump and return to the Status screen press the insulin button lit up in green below the diabetes manager screen Attaching the infusion assembly to the body Follow the action steps in chapter 4 3 1 Attaching the Infusion Assembly to the Body man_07866364001_C_en UK indb 189 12 10 2018 13 09 31 ...

Page 202: ...ling aid Protective film for battery Have the following at hand for this process j j Reservoir assembly j j Insulin vial with U100 insulin j j Disinfectant or sterile alcohol wipe Note Always fill the reservoir with at least 80 U The reservoir has a maximum holding capacity of 200 U 2 0 ml man_07866364001_C_en UK indb 190 12 10 2018 13 09 31 ...

Page 203: ... issues the Cancel signal sequence 3 Press the flap to detach the micropump and remove the pump from the infusion assembly Removing the reservoir 4 Remove the used reservoir from the pump base Wait at least 15 seconds after removing the used reservoir before you connect a new reservoir to the pump base man_07866364001_C_en UK indb 191 12 10 2018 13 09 32 ...

Page 204: ... on the display tap Done 5 Dispose of the used reservoir according to local regulations Tap Done Follow the action steps in chapters 4 3 2 Filling the Reservoir with Insulin 4 3 3 Connecting the Reservoir to the Pump Base 4 3 5 Filling the Reservoir Needle 4 3 6 Attaching the Micropump 4 3 7 Activating the Basal Rate Profile man_07866364001_C_en UK indb 192 12 10 2018 13 09 33 ...

Page 205: ...ess have the following components ready j j A new pump base j j A new reservoir assembly j j An insulin vial with U100 insulin j j Disinfectant or a sterile alcohol wipe Note j j Refer to the information in chapter 4 Putting the Micropump into Operation j j When you replace the pump base all settings saved for the pump in the diabetes manager are preserved j j Each pump base can only be paired onc...

Page 206: ...3 4 Pairing the Diabetes Manager and Micropump 4 3 5 Filling the Reservoir Needle 4 3 6 Attaching the Micropump 4 3 7 Activating the Basal Rate Profile 4 Dispose of the used reservoir and the used pump base according to local regulations Tap Done 3 Removing the pump Press the flap of the infusion assembly Remove the used micropump from the infusion assembly man_07866364001_C_en UK indb 194 12 10 2...

Page 207: ...ay each single logbook entry on the screen of the diabetes manager There you will find all the information about blood glucose results along with time of test carbohydrates health events and boluses In addition you can change the entries in the logbook or add new ones The diabetes manager automatically stores up to 5 000 logbook entries with the time and date You can view the most recent 250 logbo...

Page 208: ...s distribution meal correction insulin and carbohydrates consumed j j Logbook data that has been used for bolus advice cannot be subsequently adjusted j j You should enter any boluses that were delivered independently of the diabetes manager using an insulin pen or syringe as new data in the logbook j j Once 5 000 entries have been saved in the logbook adding a new entry causes the oldest logbook ...

Page 209: ... Symbol for blood glucose result range information 5 Symbol for bolus advice 6 Symbol for bolus type 7 Symbol for carbohydrates 8 Carbohydrate amount 9 Bolus amount 10 Blood glucose result 11 Symbol for STOP mode 12 Symbol for health event 13 Symbol for note 14 Time of entry 15 Symbol for general time of test 16 Date of entry 10 2 1 Understanding the Logbook Main menu My data Logbook 6 E F C D B 8...

Page 210: ... insulin from an injection Manual bolus with pen syringe Bolus was delivered using an insulin pen or syringe Bolus advice accepted Bolus advice from the diabetes manager was accepted Bolus advice not accepted Bolus advice from the diabetes manager was changed prior to delivery Carbohydrates Carbohydrate data exists for the logbook entry Time of test Data regarding the time of test exists for the l...

Page 211: ...splay upwards or downwards to view additional logbook entries Tap a logbook entry if you want to view or adjust the details Tap the entry you want to view or adjust 1 2 Tap My data Tap Logbook 199 Logbook 10 man_07866364001_C_en UK indb 199 12 10 2018 13 09 36 ...

Page 212: ...st for example Before meal Tap Save Time of test Carbohydrates 7 8 On the Logbook entries display tap Health events Tap the appropriate entries You can select up to 4 health events Tap Save On the Logbook entries display tap Bolus The display informs you about the bolus delivered Tap Bolus Health events Bolus 200 My Data man_07866364001_C_en UK indb 200 12 10 2018 13 09 37 ...

Page 213: ...e The bolus advice feature initially treats quick boluses as correction insulin Mark the quick boluses in the logbook as a meal bolus or correction bolus according to their purpose Enter consumed carbohydrates in the logbook 201 Logbook 10 man_07866364001_C_en UK indb 201 12 10 2018 13 09 37 ...

Page 214: ...hen tap Save On the Logbook display tap to add new data to the logbook Note You can also access the Add data display by tapping the Add data function button on the Status screen or in the Main menu 202 My Data man_07866364001_C_en UK indb 202 12 10 2018 13 09 37 ...

Page 215: ... The distance from the top edge of the graph shows the basal rate 4 Bolus Pink bars Show the amounts of bolus insulin 5 Blood glucose result Crosses x Individual blood glucose results that are connected by lines 6 Carbohydrates Brown bars Show the carbohydrate amount consumed 7 Hypo warning limit Red line Hypo warning limit 8 Blood glucose target range Green area Range between the lower and upper ...

Page 216: ...ected time period is 3 U h the scale will show the range from 0 to 5 U h On the lower left side mmol L of the graph the blood glucose result is displayed By means of the scale you can read the blood glucose results which are represented by a black line The black line connects the individual test results indicated by a cross Scaling depends on the largest blood glucose value measured during the sel...

Page 217: ...from 0 to 15 U On the lower right side g of the graph the carbohydrate amount is displayed By means of the scale you can read the carbohydrate values which are represented by the brown bars The scale comprises a range of 40 80 120 160 200 or 240 g or the equivalent scale for BE KE or CC Scaling depends on the largest carbohydrate amount consumed during the selected time period Example For example ...

Page 218: ...nd Graph Tap the desired time period Tap Save Tap the setting you want to change Tap one or more of the available graph options for example Bolus to be displayed in the graph Tap Save Time scale Graph options mmol L 206 My Data man_07866364001_C_en UK indb 206 12 10 2018 13 09 39 ...

Page 219: ...ries are to be represented Only the logbook entries are displayed for which you entered the selected time of test Tap the appropriate time of test for example After meal Tap Save Time of test 207 Trend Graph 10 man_07866364001_C_en UK indb 207 12 10 2018 13 09 39 ...

Page 220: ...ion indicates how the blood glucose results are scattered around the blood glucose average A high standard deviation means that the blood glucose results are scattered away from the blood glucose average 1 Time scale Represented time period for example 7 days 2 Hyper warning limit Blue line Hyper warning limit 3 x Single blood glucose result 4 x Average 5 Time axis Monday to Sunday 6 Blood glucose...

Page 221: ...ale 2 Selected time of test 3 Number of tests on the day of the standard week 4 Standard deviation SD of the day of the standard week 5 Highest blood glucose result of the day of the standard week 6 Blood glucose average of the day of the standard week 7 Lowest blood glucose result of the day of the standard week 8 Day of the week 1 2 7 8 6 5 4 3 mmol L Min ø Max SD Tests Mon Tue Wed Thu Fri Sat S...

Page 222: ...d time period Tap Save Tap one of the entries available for selection Make the desired settings Tap Done Tap the appropriate time of test Tap Save 10 4 1 Displaying the Standard Week Graph Time scale Time of test mmol L 210 My Data man_07866364001_C_en UK indb 210 12 10 2018 13 09 41 ...

Page 223: ...orwards in time within the selected time period 1 Time scale Illustrated time period 2 Selected time of test Displays logbook entries entered for this time of test 3 Target range chart Shows the target ranges of blood glucose results as a pie chart 4 Percentage distribution Shows the percentage of blood glucose results in each blood glucose result range 5 Blood glucose result ranges Coloured repre...

Page 224: ...backwards or forwards in time according to the selected time period 1 Time scale Illustrated time period 2 Blood glucose result ranges Coloured representation of the blood glucose result ranges 3 Number Number of test results in one of the ranges 4 Times of test Shows the logbook entries for this time of test 2 1 3 4 212 My Data man_07866364001_C_en UK indb 212 12 10 2018 13 09 42 ...

Page 225: ...ge Data Tap the desired time period Tap Save Tap one of the entries available for selection Make the desired settings and then tap Done Tap the appropriate time of test for example Bedtime Tap Save Time scale Time of test 213 Target Range 10 man_07866364001_C_en UK indb 213 12 10 2018 13 09 43 ...

Page 226: ... time period 2 Number of tests Shows the number of test results used for the calculation 3 Blood glucose standard deviation Indicates how the blood glucose results are scattered around the blood glucose average 4 Blood glucose average Average for the selected time period 5 Times of test Shows the logbook entries for this time of test mmol L SD Tests 2 3 4 5 1 214 My Data man_07866364001_C_en UK in...

Page 227: ... change the settings for the time period or time of test Tap the desired time period Tap Save 10 6 1 Displaying the BG Averages Table 215 BG Averages Table 10 man_07866364001_C_en UK indb 215 12 10 2018 13 09 44 ...

Page 228: ...red Information Information about the micropump currently in use 10 7 1 Event Data This display lets you access the last 90 maintenance warning and error messages with the most recent entry displayed first Example Each entry includes the following data j j Type and number of the maintenance warning or error message j j Title of the maintenance warning or error message j j Time j j Date Note If a r...

Page 229: ...mple Each entry includes the following data j j Start date j j Start time j j Immediate amount for the bolus for quick standard or multiwave bolus j j Delayed bolus amount for extended or multiwave bolus j j Bolus duration for extended or multiwave bolus Example Each entry includes the following data j j Start date j j Start time j j TBR as a percentage j j TBR duration 217 System Events 10 man_07...

Page 230: ...rmation about the micropump currently in use Example Each entry includes the following data j j Daily insulin total delivered as a bolus j j Daily insulin total delivered as a basal rate j j Daily insulin total delivered j j Date Example This view includes the following data j j Micropump remaining running time j j Micropump serial number j j Micropump battery status j j Micropump firmware version...

Page 231: ...ccu Chek Smart Pix software For more information see the User s Manual for the software used Install the software before you begin the data transfer w WARNING Only use the supplied USB cable 1 In the Main menu tap USB 2 The Connect to PC display appears 219 Data Transfer 10 man_07866364001_C_en UK indb 219 12 10 2018 13 09 45 ...

Page 232: ...Chek diabetes management software 3 4 Plug the smaller end micro B plug of the USB cable into the USB socket of the diabetes manager Plug the larger end USB A plug of the USB cable into a free USB port on your computer Do not use the USB charging port often indicated by a lightning bolt symbol as data is not transferred via this port 220 My Data man_07866364001_C_en UK indb 220 12 10 2018 13 09 46...

Page 233: ...r insulin sensitivity carbohydrate ratio meal rise snack size acting time and offset time see chapter 7 Bolus Advice For information on reminder settings see chapter 12 Reminders Note When you edit a setting any unsaved changes will be discarded when the diabetes manager turns off or a test strip is inserted into the test strip slot 1 2 In the Main menu tap the Settings menu Scroll the list upward...

Page 234: ...that best fit your needs Whenever your blood glucose result is above the hyper warning limit or below the hypo warning limit the diabetes manager displays a warning Tap Upper warning limit or Lower warning limit Use and to set the upper warning limit Tap OK Upper limit value man_07866364001_C_en UK indb 222 12 10 2018 13 09 47 ...

Page 235: ...gs tap the respective entry Tap Micropump remain running time days Lower limit value Remaining running time The warning limit for the remaining running time of the micropump indicates the number of days as of which you want to receive a warning regarding the remaining running time of the micropump man_07866364001_C_en UK indb 223 12 10 2018 13 09 47 ...

Page 236: ...ber of days as of which you want to receive a warning Tap Save The warning limit for the reservoir level indicates the number of insulin units as of which you want to receive a warning regarding the remaining insulin amount The remaining insulin amount is the insulin amount that is still available in the micropump reservoir man_07866364001_C_en UK indb 224 12 10 2018 13 09 48 ...

Page 237: ...cropump stops insulin delivery This could happen for example if you are no longer able to stop the pump yourself due to severe hypoglycaemia The automatic off function is turned off by default Note It is advisable to set a time span for the automatic off function that is longer than your usual bedtime period 1 2 Tap Automatic off Tap Status to turn the automatic off function on or off man_07866364...

Page 238: ...226 Changing Settings 3 5 4 Tap Inactivity Tap Done Use and to set the number of hours after which the bolus delivery will be interrupted Tap OK man_07866364001_C_en UK indb 226 12 10 2018 13 09 50 ...

Page 239: ...n properly Having the wrong time set may result in the delivery of incorrect insulin amounts thus leading to hyperglycaemia or hypoglycaemia j j Switching the system time to the respective time zone local time of your long distance journey may result in the basal rate and bolus advice to be inappropriate When travelling across multiple time zones discuss the adjustments necessary for basal rate an...

Page 240: ...228 Changing Settings 3 4 Use and to set the hours and minutes for the current time Tap OK Use and to set the day month and year Tap OK 5 Then tap OK man_07866364001_C_en UK indb 228 12 10 2018 13 09 52 ...

Page 241: ...onal and you may only change them after prior consultation Otherwise there is a risk of experiencing hyperglycaemia or hypoglycaemia 1 Tap Quick bolus buttons to activate or deactivate the quick bolus buttons of the micropump Quick bolus buttons A quick bolus is a standard bolus that is programmed and delivered using the quick bolus buttons on the micropump The factory setting for the quick bolus ...

Page 242: ...nt for the quick bolus Tap Save Maximum quick bolus You use this setting to define the maximum insulin amount that may be delivered with a quick bolus Note You cannot define a maximum quick bolus that is greater than the maximum bolus amount For more information see section Maximum bolus amount man_07866364001_C_en UK indb 230 12 10 2018 13 09 52 ...

Page 243: ...uttons while programming a quick bolus You can set the following quick bolus increments j j 0 2 U j j 0 5 U j j 1 0 U j j 2 0 U Note down the set quick bolus increment in the detachable quick reference instructions supplied in the cover of this User s Manual Example With a quick bolus increment of 0 5 U you have to press the quick bolus buttons 5 times to deliver an insulin amount of 2 5 U man_078...

Page 244: ...ting specifies the maximum insulin amount that may be delivered in any bolus Bolus advice that exceeds the maximum bolus amount requires additional confirmation or must be reduced A manual bolus is upwardly limited by the maximum bolus amount selected Note For the maximum bolus you can set an amount between 1 U and 50 U man_07866364001_C_en UK indb 232 12 10 2018 13 09 54 ...

Page 245: ...ify an interval between programming a bolus and the actual start of bolus delivery For more information see chapter 6 8 Setting the Delivery Lag Time Note j j While programming a bolus you can set a delivery lag time of 0 15 30 45 or 60 minutes j j If a bolus contains correction insulin or if the blood glucose result is above the target range it is not possible to enter a delivery lag time Correct...

Page 246: ...le a warning You can choose whether the diabetes manager issues an acoustic signal vibrates or both The settings you make are referred to as signal mode in the rest of this User s Manual You can also suspend the signals for warnings for a specific period of time for example over night w WARNING If you ignore or do not notice the messages from the micropump system there is a risk of hypoglycaemia o...

Page 247: ...or off Tap OK Tap Vibration Tap OK Tap Blood glucose test to turn the signals for a blood glucose test on or off Once you have made the desired setting tap Done Blood glucose test Volume Vibration Note When the volume slider is set to 0 percent in the far left position vibration is automatically turned on man_07866364001_C_en UK indb 235 12 10 2018 13 09 56 ...

Page 248: ...l rate or bolus Tap Done Insulin delivery signal Note Signals during a blood glucose test j j Insert test strip j j Blood application detected j j Test completed 6 Tap Touchscreen feedback to set how the diabetes manager reacts when you make a selection using the touchscreen Once you have made the desired setting tap Done Touchscreen feedback man_07866364001_C_en UK indb 236 12 10 2018 13 09 57 ...

Page 249: ...signals for reminders and warnings You cannot however turn off maintenance and error messages because these events require your attention You can set up signal suspension as a one time event or as an event that is repeated at the same time every day Note j j Signal suspension applies only for the diabetes manager and micropump warnings j j Warnings that occur during signal suspension are displayed...

Page 250: ...atus to turn on the Turn off signals feature Tap Start time to set the start of signal suspension Use and to set the hours and minutes for the start time Tap OK 2 Tap Turn off signals man_07866364001_C_en UK indb 238 12 10 2018 13 09 58 ...

Page 251: ...K Note If you use the Once setting the signals for reminders and warnings are turned off only once for the time period you specified If you use the Repeat setting the signals for reminders and warnings are turned off daily during the time period you specified Once the signal suspension time has expired the signals for the reminders and warnings that occurred are issued again man_07866364001_C_en U...

Page 252: ...ect the language for the texts displayed on the screen from a predefined list of languages j j Brightness You can adjust the brightness of the diabetes manager screen for different lighting conditions j j Check system functions For more information see chapter 14 Care and Maintenance 2 Tap the entry for the language in which you want the menus and texts to appear on the screen man_07866364001_C_en...

Page 253: ...l Settings 11 1 2 Brightness Tap Done to return to the list of settings Set the screen brightness by moving the slider j j Right bright j j Left dark Tap Save man_07866364001_C_en UK indb 241 12 10 2018 13 10 00 ...

Page 254: ...o be used for access The PIN is an identification code with four to eight digits that you enter and change in the Screen lock menu w WARNING To prevent unauthorised access you should always leave the screen lock turned on this way the therapy settings cannot be changed by third parties Note j j The screen lock is turned on by factory default j j If you want to change the PIN you have to turn the s...

Page 255: ...r information Tap Yes if you do not want to enter a PIN or if you want to change the PIN 5 6 Enter a PIN with 4 to 8 digits Tap OK Tap Status PIN to turn on the screen lock Turning on the screen lock 4 Enter the PIN to confirm it Tap OK man_07866364001_C_en UK indb 243 12 10 2018 13 10 02 ...

Page 256: ...r the background of the active screen lock Then tap Done Changing the background image 7 Enter the PIN again to confirm it Tap OK Note If you have forgotten the PIN you chose you can unlock the diabetes manager with a PIN unlock code You can find the label with the 8 digit PIN unlock code on the back cover of the User s Manual man_07866364001_C_en UK indb 244 12 10 2018 13 10 03 ...

Page 257: ... battery j j Date of manufacture j j Diabetes manager hardware update j j Number of resets times switched on off j j Number of blood glucose tests control tests j j Serial number micropump battery status micropump firmware version In addition you can read legal information and the License Terms and Conditions Some of this information is primarily used by technical customer support and may be reque...

Page 258: ...s 3 4 Tap the Legal information entry to view the stored license agreements Scroll the display upwards to be able to read more text Tap to return to the previous display man_07866364001_C_en UK indb 246 12 10 2018 13 10 03 ...

Page 259: ...ocks in summer and winter time Example You change the time of the micropump system from 10 00 to 13 00 After the change the micropump delivers the basal rate for that time at 13 00 For information on how to change the date and time settings of the micropump system see chapter 11 2 Time and Date Flight mode If the use of Bluetooth wireless technology is not allowed for flights you can turn on fligh...

Page 260: ...y set to flight mode Tap Status to put the switch in the ON position Tap Done In the Main menu tap Flight mode The symbol in the status bar indicates that flight mode is turned on No micropump data is displayed in flight mode 11 9 1 Turning On Flight Mode man_07866364001_C_en UK indb 248 12 10 2018 13 10 04 ...

Page 261: ...tch in the OFF position In the Main menu tap the Flight mode menu 11 9 2 Turning Off Flight Mode Note It is not possible to turn off flight mode on the micropump using the diabetes manager To turn off flight mode on the pump you must use the quick bolus buttons man_07866364001_C_en UK indb 249 12 10 2018 13 10 05 ...

Page 262: ...d signal sequence Tap Next Tap Done Press both quick bolus buttons 3 times simultaneously in quick succession A maximum of 3 seconds may pass between each key press Flight mode is turned off The flight mode symbol is no longer displayed in the status bar 3 man_07866364001_C_en UK indb 250 12 10 2018 13 10 06 ...

Page 263: ...e factory settings all reminders are deactivated You can turn the reminders on or off by using the ON and OFF switch You can make different settings for the various reminder types Setting Explanation Time The time of day the reminder occurs Date The date the reminder occurs Remind after Period of time following an event for example blood glucose value being too high after which a reminder is to oc...

Page 264: ...lood glucose result Reminds you to test your blood glucose if your test result was below the set blood glucose value Test after high blood glucose result Reminds you to test your blood glucose if your test result was above the set blood glucose value Missed bolus This reminder occurs if no bolus was delivered within 2 hours prior to the programmed time Inject basal insulin Reminds you to deliver b...

Page 265: ...f the event at certain intervals for example daily Some reminders only appear when certain conditions are met You can add more reminders by tapping Once the maximum number of reminders has been reached you will see the information that no more reminders can be added instead of the symbol By tapping you can delete reminders you added You can assign a tone from an option list to each programmed remi...

Page 266: ...tch in the ON position Tap Recurrence Time Tone to make the desired settings Once you have made all settings tap Done 12 2 1 Reminder Replace Infusion Assembly This reminder reminds you to replace your infusion assembly man_07866364001_C_en UK indb 254 12 10 2018 13 10 08 ...

Page 267: ...15 characters Tap Done Tap Status to put the switch in the ON position Tap Time Tone or Frequency to make the desired settings Once you have made all settings tap Done 1 2 Tap to assign a name to the alarm clock reminder 12 2 2 Reminder Alarm Clock Tap Alarm clock 1 man_07866364001_C_en UK indb 255 12 10 2018 13 10 09 ...

Page 268: ...utes 1 12 2 3 Reminder Test Blood Glucose Tap Test blood glucose 2 Tap Status to put the switch in the ON position Tap Time Tone or Frequency to make the desired settings Once you have made all settings tap Done This reminder reminds you to test your blood glucose at a time that was specified beforehand man_07866364001_C_en UK indb 256 12 10 2018 13 10 09 ...

Page 269: ...ant the reminder to appear Once you have made all settings tap Done 12 2 4 Reminder After meal Tap After meal This reminder reminds you to test your blood glucose if a previously measured blood glucose result was marked as Before meal man_07866364001_C_en UK indb 257 12 10 2018 13 10 10 ...

Page 270: ...nd after or Tone to make the desired settings Once you have made all settings tap Done This reminder reminds you to test your blood glucose again when the previous test result was too low The BG threshold in this reminder can be set individually and is independent of the hypo warning limit set by you man_07866364001_C_en UK indb 258 12 10 2018 13 10 10 ...

Page 271: ...old Remind after or Tone to make the desired settings Once you have made all settings tap Done This reminder reminds you to test your blood glucose again when the previous test result was too high The BG threshold in this reminder can be set individually and is independent of the hyper warning limit set by you man_07866364001_C_en UK indb 259 12 10 2018 13 10 11 ...

Page 272: ...minder is programmed for 14 00 j j If no bolus is delivered between 12 00 and 14 00 the previously programmed reminder will occur at 14 00 j j If a bolus was delivered between 12 00 and 13 59 no reminder will occur 1 2 Tap the Missed bolus entry Tap Status to put the switch in the ON position Tap Time Tone or Frequency to make the desired settings Once you have made all settings tap Done man_07866...

Page 273: ...lthcare Professional Visit Lab Test Customised Appointment reminders are a helpful way of reminding you of an upcoming healthcare professional visit or lab test In addition you can set customised appointment reminders These reminders are displayed when you turn on the diabetes manager on the specified reminder date 1 Tap Healthcare professional visit man_07866364001_C_en UK indb 261 12 10 2018 13 ...

Page 274: ...le Custom 2 Tap the symbol to delete the reminder Tap Yes if you want to permanently delete the reminder now If required you can delete reminders you added yourself The reminders that are predefined in the system however cannot be deleted man_07866364001_C_en UK indb 262 12 10 2018 13 10 12 ...

Page 275: ...m the reminder with OK or you can specify to be reminded again in 15 minutes by tapping Snooze When turned off no reminders are issued If an event occurs during that time the reminder will be issued after the diabetes manager is turned on Reminder Replace infusion assembly Tap OK to confirm the reminder The reminder will no longer be displayed Tap Snooze if you want to be reminded again at a later...

Page 276: ...264 Reminders man_07866364001_C_en UK indb 264 12 10 2018 13 10 13 ...

Page 277: ... detailed test result and in the logbook entries of the diabetes manager j j A reminder is available that you can use to be reminded about basal insulin injections Note j j If you are using bolus advice carry out the injections in a timely fashion and using the dosage you confirmed If you inject a different insulin amount you should adjust the respective logbook entry j j You should enter any bolu...

Page 278: ...orarily 1 In the Main menu tap Stop to interrupt insulin delivery While you are delivering insulin by injection set the micropump to STOP mode take the micropump off and remove the infusion assembly 2 Tap Yes man_07866364001_C_en UK indb 266 12 10 2018 13 10 13 ...

Page 279: ...ff towards the centre 5 Remove the used reservoir from the pump base 6 Dispose of the used infusion assembly and used reservoir according to local regulations Keep the pump base in a safe place 3 Press the flap to detach the micropump and remove the pump from the infusion assembly man_07866364001_C_en UK indb 267 12 10 2018 13 10 14 ...

Page 280: ...lling the micropump will be turned off In the Main menu tap the Settings menu Tap the Change to injection therapy entry 13 1 1 Activating Injection Therapy Mode Tap the desired insulin increment for the pen Tap Save man_07866364001_C_en UK indb 268 12 10 2018 13 10 15 ...

Page 281: ...m bolus amount you want to deliver with the pen syringe Tap OK The display informs you that injection therapy mode is turned on The current bolus settings are displayed Tap OK if you want to continue with these settings man_07866364001_C_en UK indb 269 12 10 2018 13 10 16 ...

Page 282: ...njection Therapy Mode 1 2 3 Tap Yes In the Main menu tap the Settings menu Tap the Change to pump therapy entry 13 1 2 Deactivating Injection Therapy Mode man_07866364001_C_en UK indb 270 12 10 2018 13 10 16 ...

Page 283: ...rvoir If you would like to review the pump therapy settings tap Yes j j Check the bolus settings as well as the settings for the basal rate j j Select the Replace menu Replace the reservoir 5 Replace the components as needed For more information see chapter 9 Replacing System Components If you do not replace any components the micropump will remain in STOP mode In this case start the pump from the...

Page 284: ...ed Ongoing bolus information omitted Once you turn on injection therapy mode some of the displays and menus on the diabetes manager change The displays necessary for pump therapy are no longer available on the Status screen In the Main menu some of the menus are omitted from the menu selection The button to cancel an ongoing bolus is omitted in injection therapy mode 13 2 Injection Therapy Display...

Page 285: ...njection therapy Start and Stop menu is omitted Basal rate menu is omitted Replace menu is omitted Flight mode menu is omitted Test result in detail Test result in detail display in pump therapy mode Test result in detail display in injection therapy mode You will also see the entry field for basal insulin man_07866364001_C_en UK indb 273 12 10 2018 13 10 17 ...

Page 286: ...ection therapy mode The Cancel bolus element is omitted Reminders Reminders display in pump therapy mode Reminders display in injection therapy mode Instead of the Replace infusion assem reminder the Inject basal insulin reminder appears man_07866364001_C_en UK indb 274 12 10 2018 13 10 17 ...

Page 287: ...de The Micropump remain running time days Reservoir level and Automatic off options are omitted My data Logbook entries display in pump therapy mode Logbook entries display in injection therapy mode You can enter or change the amount of basal insulin delivered in the Basal insulin entry man_07866364001_C_en UK indb 275 12 10 2018 13 10 18 ...

Page 288: ...ode The Type entry provides only the Pen option Bolus settings Bolus settings display in pump therapy mode Bolus settings display in injection therapy mode Instead of the quick bolus elements the elements for setting the insulin increment and the maximum bolus amount appear man_07866364001_C_en UK indb 276 12 10 2018 13 10 18 ...

Page 289: ... to repair the diabetes manager or micropump yourself Replace the consumables for the micropump system if they are soiled 14 1 Cleaning the Micropump System Use exclusively lint free cloths and demineralised water to clean the micropump system w WARNING Use exclusively demineralised water to clean the micropump system Note j j Avoid liquid or moisture entering the openings on the diabetes manager ...

Page 290: ... not to wipe any dirt into the openings on the diabetes manager 14 1 1 Cleaning the Diabetes Manager Use only demineralised water Use neither soap nor abrasive cleaning agents as they may cause the screen to become scratched If the screen of the diabetes manager is scratched it may be difficult to read under certain circumstances In this case the diabetes manager must be replaced man_07866364001_C...

Page 291: ...an in particular hard to reach places for example around the openings 4 Wipe the diabetes manager using a dry lint free cloth 3 Min 14 1 2 Cleaning the Micropump Clean the micropump only with the reservoir attached before the reservoir is due to be replaced Replace the reservoir afterwards man_07866364001_C_en UK indb 279 12 10 2018 13 10 20 ...

Page 292: ...nd not blocked Replace the reservoir 2 Wipe the surface of the micropump for at least 3 minutes using a second lint free cloth moistened with demineralised water Clean in particular hard to reach places for example around the openings 1 Remove any large contaminants with a lint free cloth moistened with demineralised water Be careful not to wipe any dirt into the openings on the pump base 3 Min ma...

Page 293: ...tion device 2 Wipe the surface of the insertion device for at least 3 minutes using a second lint free cloth moistened with demineralised water Clean in particular hard to reach places for example around the openings 1 Remove any large contaminants with a lint free cloth moistened with demineralised water Be careful not to wipe any dirt into the openings on the insertion device 3 Min man_078663640...

Page 294: ...inger pricker to help you for example Observe the cleaning and disinfection notes in the instructions for use for the finger pricker 2 Wipe the outside and inside of the cap in the same manner Wipe the finger pricker and cap using a dry cloth 1 Wipe the surface of the finger pricker for at least 3 minutes using a lint free cloth moistened with demineralised water Clean in particular hard to reach ...

Page 295: ...ucose concentration 14 2 Control Test of the Diabetes Manager You can check whether the diabetes manager is delivering correct test results by performing a control test Perform a control test using control solution whenever j j you open a new test strip box j j you have left the test strip container open j j you think the test strips might be damaged j j the test strips were exposed to extreme tem...

Page 296: ... and test strips are functioning properly j j If a test strip error occurs remove and dispose of the test strip and repeat the test with a new test strip j j When a test strip is in the diabetes manager the touchscreen and the buttons including the power button are deactivated The buttons are activated again when you remove the test strip or the test is complete j j Another way to start a control ...

Page 297: ...w The device turns on automatically and the LED at the test strip slot lights up If the tone for blood glucose tests is turned on a signal sounds Select the control solution to test 14 2 2 Performing a Control Test Check the use by date that is indicated on the test strip container next to the e symbol Use only test strips that are not past the use by date Care and Maintenance man_07866364001_C_en...

Page 298: ...ouch the drop to the front edge of the yellow window of the test strip Do not put control solution on top of the test strip Testing starts when there is enough control solution in the test strip Applying a drop 8 Wipe the tip of the bottle with a paper towel Cap the bottle tightly man_07866364001_C_en UK indb 286 12 10 2018 13 10 29 ...

Page 299: ...lt is displayed Tap the control solution you used for example Control 1 If the control result is within the permitted concentration range the diabetes manager and test strips are working properly Tap OK Displaying the control result Note If you choose No entry the control test display shown in the next step will not appear The control result will not be analysed Continue with Step 12 Care and Main...

Page 300: ...ccording to local regulations The table in the following section lists the causes of a control result outside the permitted concentration range or of the LO and HI displays Tap OK Disposing of test strips man_07866364001_C_en UK indb 288 12 10 2018 13 10 30 ...

Page 301: ...t j j Was the test strip straight not bent j j Did you perform the control test within the correct temperature range j j Did you select the control solution on the Control test display that corresponds to the control solution you used j j Is the test strip slot clean j j Has the control solution bottle been open for less than 3 months j j Did you observe the sections Performing a Control Test and ...

Page 302: ... or suspect that there might be other defects you can perform a system function test This test checks whether the screen vibration and signal features are working properly If the diabetes manager does not work as described in the explanations of the system function test contact your Customer Support and Service Centre 14 3 Checking the System Functions In the Main menu tap the Settings menu Tap Ge...

Page 303: ...hite in quick succession In addition the diabetes manager vibrates whenever the display changes Tap Check system functions Tap Screen Checking the screen 6 Tap Diabetes manager signals The diabetes manager sounds 1 signal Diabetes manager signals man_07866364001_C_en UK indb 291 12 10 2018 13 10 31 ...

Page 304: ...manager vibrates Tap Micropump signals The micropump sounds 1 signal Diabetes manager vibration Micropump signals Note If you are using injection therapy mode the Micropump signals entry will be deactivated and greyed out man_07866364001_C_en UK indb 292 12 10 2018 13 10 31 ...

Page 305: ...e screen is turned on w WARNING If you ignore or do not notice the messages from the micropump system there is a risk of hypoglycaemia or hyperglycaemia which may culminate in ketoacidosis When a message is displayed pick up the diabetes manager to receive further information and be able to react to the message In the lower part of the display selection or confirmation buttons are displayed The bu...

Page 306: ...tions If the problem cannot be resolved using the suggested solutions contact your Customer Support and Service Centre Note j j If the micropump signals a maintenance or error message and you do not have the diabetes manager at hand you can mute the message for 5 minutes using the quick bolus buttons on the micropump Note that you cannot use the quick bolus buttons to deliver a quick bolus before ...

Page 307: ...ation messages with OK or if it is a question answer it with Yes or No Examples of information messages 1 Information on the micropump Information on the diabetes manager 2 Title of information message 3 Information message symbol 4 Information or explanation 5 Buttons OK No Yes man_07866364001_C_en UK indb 295 12 10 2018 13 10 32 ...

Page 308: ...term to ensure the complete functionality of the micropump system When a warning is displayed the diabetes manager issues the Warning signal sequence and vibrates For more information on the sequences of signals see chapter 17 3 Signals Examples of warnings 1 Warning code 2 Warning refers to the micropump Warning refers to the diabetes manager 3 Title of warning 4 Warning symbol 5 Explanation of w...

Page 309: ... amount of insulin in the reservoir Be prepared to replace the reservoir soon W 32 Battery almost empty The battery level is low Replace the reservoir W 35 Limited battery power The opening that is intended for battery ventilation is covered this means that the energy supplied by the battery is restricted Make sure that there is an unrestricted air supply to the opening for ventilation on the micr...

Page 310: ...t for your insulin needs Test your blood glucose at shorter intervals W 38 Bolus cancelled An ongoing bolus was cancelled Make sure that the cancellation was intentional Note the insulin amount already delivered and program a new bolus if necessary W 40 Replace reservoir The operating life of the reservoir will soon come to an end Replace the reservoir as soon as possible W 41 Micropump stopped Th...

Page 311: ...re are no obstacles between them W 73 No connection to the micropump No current data from the micropump is available The data for calculating the bolus advice may not be up to date The data is updated when the connection between the diabetes manager and the micropump is re established W 75 Warning limit exceeded High blood glucose value Test ketones and your blood glucose Check the insulin deliver...

Page 312: ...od glucose result may be very low Eat or drink fast acting carbohydrates Test your blood glucose again and then again within the next half hour If hypoglycaemia persists consult your healthcare professional W 84 Testing not possible You cannot test your blood glucose while the diabetes manager is connected to a USB cable Remove the USB cable from the diabetes manager W 85 Bolus data missing A prob...

Page 313: ... is turned off and the diabetes manager and micropump are within communication range the data will be synchronised The data for bolus advice will then be up to date again W 88 Flight mode on The saved logbook entries may not be up to date When flight mode is turned off and the diabetes manager and micropump are within communication range the logbook entries will be synchronised W 89 Check logbook ...

Page 314: ...t to be delivered in the current time block is so low that it falls below the smallest delivery amount the pump can technically deliver Check whether it is acceptable for you for no insulin to be delivered in this time period The insulin amount that was not delivered will be delivered later on during the next time blocks man_07866364001_C_en UK indb 302 12 10 2018 13 10 33 ...

Page 315: ...ounds when the Turn off signals feature is turned on For more information on the sequences of signals see chapter 17 3 Signals w WARNING If you do not correct the cause of the occlusion message M 24 insulin delivery may not function or may function only to a limited extent This can lead to hyperglycaemia Examples of maintenance messages 1 Code of maintenance message 2 Maintenance activity refers t...

Page 316: ...orrespond to the measured reservoir level Replace the reservoir if required with a new reservoir M 21 Reservoir empty The insulin in the reservoir has been used up Select the Replace menu and replace the reservoir M 22 Micropump battery empty The micropump battery which is located in the reservoir is empty Select the Replace menu and replace the reservoir M 23 Automatic off The automatic off featu...

Page 317: ...e The reservoir needle must be refilled after replacing the reservoir Remove the micropump from the infusion assembly Select the Replace menu and replace the reservoir After that follow the instructions for filling the reservoir M 27 No data connection The micropump system setup was interrupted Hold the diabetes manager close to the micropump to ensure that data is exchanged between the pump and t...

Page 318: ...r control solution is not sufficient to perform a test Repeat the test with a new test strip Make sure the blood drop or drop of control solution is large enough M 56 Drop applied too early The drop was drawn into the test strip before Apply drop appeared on the screen Repeat the test with a new test strip and a fresh blood drop or drop of control solution M 58 Temperature too high or too low The ...

Page 319: ...iabetes manager M 62 Connection failed The pairing code was not scanned successfully This may be the case for example if it is too dark or if the code or camera lens is dirty and the code cannot be read correctly Try rescanning the pairing code on the micropump Alternatively you can enter the pump key manually M 64 Bolus delivery not possible The connection between the diabetes manager and micropu...

Page 320: ...oo high or too low Make sure the ambient temperature is within the permitted range Wait 5 minutes until the diabetes manager has adapted itself to this temperature M 85 Micropump incompatible You tried to pair the diabetes manager with a pump base that is incompatible Contact your Customer Support and Service Centre M 86 Micropump not started The micropump cannot be started because ongoing process...

Page 321: ...ned on on the micropump Hold the diabetes manager close to the micropump M 94 Connection failed There is a communication problem between the micropump and the diabetes manager Hold the diabetes manager close to the micropump and ensure that data communication is not disrupted Check the micropump M 95 No micropump located A connection to the micropump could not be established Check whether the micr...

Page 322: ...d on The vibration feature cannot be turned off For more information on the sequences of signals see chapter 17 3 Signals For most problems the diabetes manager displays a message with a short description of the problem and a proposed solution If the problem cannot be resolved using the suggested solutions switch to alternative therapy methods and contact your Customer Support and Service Centre E...

Page 323: ...ropump and diabetes manager is not possible The micropump switches to STOP mode and does not deliver any insulin Select the Replace menu and replace the reservoir Wait at least 30 seconds after removing the used reservoir before connecting a new reservoir to the pump base If the problem persists replace the micropump E 8 Micropump battery error The energy supply is defective The micropump switches...

Page 324: ...tes manager E 57 Electronic error The diabetes manager was restarted due to an electronic error If the problem recurs contact your Customer Support and Service Centre E 60 Internal clock error Internal clock error in the diabetes manager Contact your Customer Support and Service Centre man_07866364001_C_en UK indb 312 12 10 2018 13 10 34 ...

Page 325: ... into Operation The rechargeable battery may be damaged Replace the rechargeable battery if the diabetes manager cannot be charged An electronic error has occurred in the diabetes manager Reset the diabetes manager by pressing and holding the power button for at least 5 seconds The ambient temperature is higher or lower than the operating temperature recommended for the diabetes manager Move the d...

Page 326: ...betes manager by pressing and holding the power button for at least 5 seconds until the screen turns off Remove the rechargeable battery from the diabetes manager and reinsert it The screen is defective or the colours are not represented correctly The screen is damaged or the diabetes manager is defective Perform the system function test for the diabetes manager screen For more information see cha...

Page 327: ...tion test shows a problem with the signals of the diabetes manager or micropump contact your Customer Support and Service Centre The start time for the first time block cannot be changed Initial setup is already complete and therefore the start time for the first time block cannot be changed any more To change the start time for the first time block select the Reset option on the Time blocks displ...

Page 328: ...e micropump was turned off by the automatic off feature Check the settings for the automatic off feature For more information see chapter 11 1 Warning Limits The micropump turned off without prior notice due to an electronic defect Check whether the micropump is turned off To do this with the quick bolus feature activated press and hold both quick bolus buttons simultaneously for approximately 3 s...

Page 329: ...p are within communication range The micropump turned off due to an electronic defect E 7 Select the Replace menu and replace the reservoir Wait at least 30 seconds after removing the used reservoir before connecting a new reservoir to the pump base If the problem persists replace the micropump For more information see chapter 9 Replacing System Components man_07866364001_C_en UK indb 317 12 10 20...

Page 330: ...318 Messages and Troubleshooting man_07866364001_C_en UK indb 318 12 10 2018 13 10 35 ...

Page 331: ...on a control system that consists of two microprocessors and a supervisor microprocessor supervising system The control system has a dual channel software architecture that performs all safety relevant functions twice Whenever a defect or fault occurs in the control system it is identified by the supervisor microprocessor and vice versa The control and supervising systems signalise errors by means...

Page 332: ... Transmission power 1 mW 0 dBm Channels 37 FHSS 3 DSSS advertising channels Modulation GFSK Bandwidth 1 MHz single hop frequency Communication range 2 m the range may be impaired by obstacles man_07866364001_C_en UK indb 320 12 10 2018 13 10 35 ...

Page 333: ...d protection Dimensions 124 64 17 mm L W H Weight 140 g Signal reproduction Graphical user interface status LED speakers vibration alarm Screen Capacitive colour LCD multi touch screen with backlight Screen size 3 5 Screen resolution 320 480 pixels Screen timeout After 2 minutes of no activity Camera 2 megapixels for scanning the pairing code 2D data matrix code at a minimum of 300 lx up to a maxi...

Page 334: ...g 5 to 85 During operation 15 to 90 Atmospheric pressure Storage and transport with packaging 54 9 kPa to 106 kPa 549 mbar to 1060 mbar During operation 70 kPa to 106 kPa 700 mbar to 1060 mbar During charging 80 kPa to 106 kPa 800 mbar to 1060 mbar Storage between periods of use 54 9 kPa to 106 kPa 549 mbar to 1060 mbar Operating height Up to 3 000 m above sea level diabetes manager Up to 2 000 m ...

Page 335: ...wer supply model TS051X110 0502R IP rating IP20 Bolus calculator Accu Chek Bolus Advisor Test strip slot Illuminated test strip slot for Accu Chek Aviva test strips Measuring range 0 6 33 3 mmol L 10 600 mg dL Test principle Refer to the test strip package insert Test time Refer to the test strip package insert Blood sample Refer to the test strip package insert Sample type Refer to the test strip...

Page 336: ...packaging reservoir 10 C to 30 C During operation and storage between uses 5 C to 40 C Cooling down time from maximum storage temperature between periods of use to operating temperature at an ambient temperature of 20 C 10 minutes 4 Warming up time from minimum storage temperature between periods of use to operating temperature at an ambient temperature of 20 C 10 minutes 5 Admissible humidity ran...

Page 337: ... 0 1 U 5 or better at 1 0 U Basal rate increments 0 1 U up to under 5 0 U increments of 0 01 U 5 0 U up to under 25 0 U increments of 0 1 U Basal rate profiles Up to 5 customised profiles Temporary Basal Rate TBR 0 90 for basal rate reductions and 110 250 for basal rate increases in increments of 10 The duration is adjustable in 15 minute increments for a time period of up to 24 hours Up to 5 indi...

Page 338: ...e in 15 minute increments for a time period of up to 24 hours Delivery lag time Adjustable in 15 minute increments from 0 to 60 minutes Quick bolus increment 0 2 U 0 5 U 1 0 U and 2 0 U Delivery speed Boluses 1 0 2 5 U min Filling the reservoir needle 1 0 2 5 U min Sound pressure level of the signal 45 dBA at a distance of 1 m Occlusion detection Rotation detector Maximum amount of time until occl...

Page 339: ...opump 16 Technical data of the micropump Reservoir fill amount Maximum 200 U Minimum 80 U Maximum overdelivery in the event of an error 0 4 U IP rating IP22 man_07866364001_C_en UK indb 327 12 10 2018 13 10 35 ...

Page 340: ...ad Dimensions Approx 85 52 mm Cannula Orange 6 mm soft Teflon catheter 90 insertion angle Blue 9 mm soft Teflon catheter 90 insertion angle Cannula fill amount 0 7 U Maximum period of use up to 3 days Sterility Sterilised using ethylene oxide for single use according to EN ISO 11135 man_07866364001_C_en UK indb 328 12 10 2018 13 10 35 ...

Page 341: ...3 49 mm L W H Weight 85 g Period of use 720 insertions This corresponds to a period of use of approximately 4 years You can program a reminder in the diabetes manager to remind you to replace the insertion device before the end of the period of use man_07866364001_C_en UK indb 329 12 10 2018 13 10 35 ...

Page 342: ...is adequate for the patient in question The delivery accuracy does not depend on the length of the cannula used The measurements were carried out according to IEC 60601 2 24 under the following conditions Description Value Unit Temperature 21 6 C Relative humidity 50 30 Atmospheric pressure 1013 50 hPa man_07866364001_C_en UK indb 330 12 10 2018 13 10 35 ...

Page 343: ...changes in the delivery rate over the stabilisation period 0 1 U h 6 mm cannula Actual flow Target flow Time min Flow ml h 0 000 0 002 0 004 15 90 165 240 315 390 465 540 615 690 765 840 915 990 1065 1140 1215 1290 1365 1440 man_07866364001_C_en UK indb 331 12 10 2018 13 10 35 ...

Page 344: ... cannula Flow ml h Time min 0 000 0 002 0 004 0 006 0 008 0 010 0 012 15 90 165 240 315 390 465 540 615 690 765 840 915 990 1065 1140 1215 1290 1365 1440 Actual flow Target flow man_07866364001_C_en UK indb 332 12 10 2018 13 10 35 ...

Page 345: ...annula 92 0000 43 0000 14 4000 3 6364 0 3158 1 4839 204 0000 64 0000 24 8000 14 3636 9 7895 7 6129 4 5200 150 100 50 0 50 100 150 200 250 0 60 120 180 240 300 360 420 480 540 600 660 720 780 840 900 960 Observation period min Error as percentage Minimum flow error Maximum flow error Total error man_07866364001_C_en UK indb 333 12 10 2018 13 10 36 ...

Page 346: ... 14 0000 6 4000 2 6400 0 8727 0 4000 0 1484 0 8240 40 30 20 10 0 10 20 0 60 120 180 240 300 360 420 480 540 600 660 720 780 840 900 960 Observation period min Error as percentage Minimum flow error Maximum flow error Total error man_07866364001_C_en UK indb 334 12 10 2018 13 10 36 ...

Page 347: ...tructions for use Caution refer to safety related notes in the instructions for use accompanying this product Follow instructions for use Temperature limitation store at Use only once Use by Symbol Meaning Sterilized using ethylene oxide Manufacturer Date of manufacture Catalogue number Batch code Serial number man_07866364001_C_en UK indb 335 12 10 2018 13 10 37 ...

Page 348: ...quency equipment has passed the equipment authorization process for the United States of America The IC ID Industry Canada Identification indicates that the radio frequency equipment has passed the equipment authorization process for Canada Symbol Meaning Keep away from sunlight Keep dry Do not use if package is damaged Admissible humidity range Admissible air pressure range Do not throw away Blue...

Page 349: ... 15 Warning against device use in electromagnetic or high electrical fields or environments Device of protection class II Suitable for indoor use only The compliance mark indicates that the 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 Australian ...

Page 350: ...l Unit also IU Unit of measurement for the amount of a biologically active substance for example insulin referring to the biological activity Abbreviation Meaning am Ante meridiem Before midday 12 hour clock notation for times before 12 noon BE Broteinheit bread equivalent BG Blood Glucose C Degrees Celsius or Centigrade CC Carbohydrate Choice F Degrees Fahrenheit FCC Federal Communications Commis...

Page 351: ...reviation Meaning U h Insulin amount delivered in units per hour U100 Insulin concentration Each millilitre of liquid contains 100 units of insulin USB Universal Serial Bus man_07866364001_C_en UK indb 339 12 10 2018 13 10 38 ...

Page 352: ...ntenance messages Warning j j Issuing warnings Connect USB j j Establishing a USB connection between the diabetes manager and a PC Disconnect USB j j Disconnecting the USB connection between the diabetes manager and a PC 17 3 2 Signals of the Micropump The micropump s acoustic signals are based on the C major scale C1 D1 E1 F1 G1 A1 B1 C2 The micropump uses the following frequencies Tone Frequency...

Page 353: ...crement j j Acoustic feedback of the programmed quick bolus increments 8 A6 A long deep tone Execute j j Confirming the programmed quick bolus increments j j Confirming the end of insulin delivery 8 A6 AIS6 B6 C7 CIS7 5 long ascending tones The last tone is longer Cancel j j Timeout while programming a quick bolus j j Programming of a quick bolus not possible j j Stopping the micropump 8 DIS7 A6 D...

Page 354: ...s Warning j j Issuing warnings 8 AIS6 B6 1 long tone followed by 1 pause and 1 higher tone The sequence of signals is repeated every 30 seconds Flight mode off j j Deactivating flight mode on the micropump 8 DIS7 D7 CIS7 C7 B6 AIS6 A6 7 short descending tones Beep j j Starting a bolus j j Starting a basal rate j j Starting a TBR 8 CIS7 A long high tone Invalid selection j j Exceeding the maximum i...

Page 355: ...irective 2014 53 EU The full text of the EU declaration of conformity may be found at the following Internet address http declarations accu chek com 18 4 Connecting Non System Devices Additional equipment connected to the diabetes manager must demonstrably comply with the relevant IEC or ISO standards for example IEC 60950 or IEC 62368 for data processing equipment Moreover all configurations must...

Page 356: ...betes Care Australia Pty Limited Pump Support 1800 633 457 www accu chek com au 18 5 Customer Support and Service Centre If you encounter problems have questions regarding operation or need additional information about the Accu Chek Solo micropump system contact your Customer Support and Service Centre Do not attempt to repair or modify the components of the micropump system yourself Our staff wil...

Page 357: ...er for the diabetes manager j j USB cable If you need to replace defective system components or need another User s Manual for the micropump system contact your Customer Support and Service Centre For information on the availability of additional Accu Chek products and accessories in your country contact the responsible Customer Support and Service Centre w WARNING j j Use only the supplied charge...

Page 358: ...our micropump system may come into contact with human bodily fluids during use it carries a risk of infection Therefore it falls outside the scope of the European Directive 2012 19 EU directive on waste electrical and electronic equipment and cannot be disposed of with other electronic devices Dispose of the used micropump system components according to local regulations Rechargeable battery of th...

Page 359: ... 1 Meal Bolus A meal bolus is the amount of insulin that needs to be delivered to compensate for the amount of carbohydrates you are planning to eat It is calculated as follows Meal bolus carbohydrate amount carbohydrate ratio The following applies here Carbohydrate ratio insulin carbohydrates 18 8 2 Correction Bolus If your current blood glucose level is not within your target range a correction ...

Page 360: ...actor meal bolus Within target range No correction bolus necessary Current BG target BG insulin sensitivity factor meal bolus The correction bolus can be negative Between lower target limit value and hypo warning limit No bolus recommended The correction bolus is negative Current BG target BG insulin sensitivity factor meal bolus The correction bolus is negative Below hypo warning limit A hypo war...

Page 361: ...arget level again The period of time from the start of the blood glucose increase until the blood glucose level returns to the target level is defined as the acting time During this time a correction bolus is only recommended if your blood glucose level exceeds the allowed value after a meal The allowed value depends on the blood glucose target value and the meal rise 18 8 3 Subsequent Meal Boluse...

Page 362: ...ter a meal bolus Bolus advice tolerates an increase in your blood glucose level within the allowed range for the meal rise green without calculating an additional correction bolus If you enter a carbohydrate amount that is greater than the snack size the set meal rise is added to the current blood glucose target value The shape of the meal rise the width of the green area is determined by the offs...

Page 363: ...ecreases after the offset time At the end of the acting time your blood glucose level should have reached the target range again You will only receive a recommendation for an additional correction bolus if your current blood glucose result is higher than the current delta BG value 1 Blood glucose result 2 Offset time 3 Delta BG 4 Correction bolus 5 Acting time 6 Time If your blood glucose result i...

Page 364: ...ious examples of how bolus advice takes different factors into account for the calculations The currently allowed blood glucose value considers the following factors j j Target BG j j Meal rise j j Delta BG man_07866364001_C_en UK indb 352 12 10 2018 13 10 41 ...

Page 365: ... range 8 Hypo 9 Time The first correction bolus at 12 00 noon remains active during the acting time width of the blue area If the blood glucose value at 14 00 drops below the currently allowed blood glucose value upper edge of the blue area no additional correction bolus will be calculated 1 3 6 2 7 8 5 4 9 After a correction bolus man_07866364001_C_en UK indb 353 12 10 2018 13 10 41 ...

Page 366: ...glucose result is above the currently allowed blood glucose value a bolus will be calculated light blue that considers only the difference between the current blood glucose value orange dots and the currently allowed blood glucose value upper edge of the dark blue area man_07866364001_C_en UK indb 354 12 10 2018 13 10 41 ...

Page 367: ...olus No bolus required Currently allowed BG value Meal rise 1 3 6 2 7 8 5 4 9 If you eat several meals one after the other that are larger than the snack size the meal rise is newly started for each meal bolus Even if you eat several meals in succession the allowed meal rise is not greater than for one meal alone man_07866364001_C_en UK indb 355 12 10 2018 13 10 42 ...

Page 368: ... rate The basal rate is the insulin amount delivered per hour to cover your meal independent insulin needs In insulin pump therapy your basal rate is determined together with your healthcare professional and can be adjusted to meet your individual physiological needs that can change as the day progresses Basal rate profile A basal rate profile consists of up to 24 time blocks An individual basal r...

Page 369: ...Settings that are independent of the time of day and affect exclusively bolus advice calculation These settings include meal rise snack size acting time and offset time Bolus advice calculation is also affected by the parameters target range insulin sensitivity and carbohydrate ratio which are dependent of the time of day and can be saved in the respective time blocks Broteinheit Bread Equivalent ...

Page 370: ...test using control solution that lets you know whether the meter unit of the diabetes manager and the test strips are working properly Current time The time you set via the Settings menu on the Time and date display Delivery lag time Period of time before delivery of a programmed bolus begins End time Time at which a time block ends Error Error messages are displayed when relevant malfunctions of ...

Page 371: ...event stands for a certain percentage according to your settings and is used to adjust bolus advice recommendations Up to 4 health events can be selected and stored with a blood glucose result HI Appears on the screen when the test result is above the diabetes manager s measurement range HI stands for high Hyper Hyperglycaemia Hypo Hypoglycaemia Immediate amount Insulin amount that is delivered at...

Page 372: ...p system Maintenance messages require you to intervene in order to solve the problem Maintenance messages of the micropump switch the micropump to STOP mode Meal rise The initially allowed increase in blood glucose level after a meal bolus Multiwave Bolus A multiwave bolus combines a standard bolus with an extended bolus A part of the bolus amount is delivered immediately whereas the other part is...

Page 373: ...stem works Snack size The snack size defines a carbohydrate threshold when this is exceeded a meal rise should be taken into account for bolus advice Thus the snack size indicates the carbohydrate amounts up to which no increase in the blood glucose level is to be tolerated after a meal Snooze Reschedules a reminder or message to reoccur after a preset period of time for example after 15 minutes S...

Page 374: ...t range and the parameters insulin sensitivity and carbohydrate ratio for bolus advice for specific times of day You can set up a maximum of 8 time blocks Time of test Information on the point in time when a blood glucose result was obtained The information can be stored together with a blood glucose result When the results are subsequently analysed either all test results can be displayed or only...

Page 375: ...yper or hypo warning limit a warning is displayed You should set the hyper and hypo warning limits together with your healthcare professional In case of blood glucose results below the lower warning limit no bolus advice will be calculated man_07866364001_C_en UK indb 363 12 10 2018 13 10 42 ...

Page 376: ... Components 6 57 period of use 185 replacing 185 Control test 283 Customer Support and Service Centre 344 A Abbreviations 338 Acting time 131 142 363 Active insulin 106 356 automatic off 360 Automatic off 225 B Basal rate profile 167 activating 172 changing 174 deleting 175 programming 52 169 Basal rate temporary see Temporary Basal Rate TBR BG averages table 214 bolus 105 cancelling 123 delaying ...

Page 377: ... screen 16 272 E error messages 310 Event data 216 Explanation of symbols 335 F Fill amount 190 flight mode 358 Flight mode 247 activating 248 turning off 249 H Health event 93 359 creating 139 I Information messages 295 Information screen 22 Infusion assembly 58 328 attaching 63 replacing 187 Infusion sites 61 Injection mode 95 265 activating 268 Main menu 273 Status screen 272 turning off 270 In...

Page 378: ...sages 296 Micropump 6 324 Accessories 345 attaching to pump holder 80 cleaning 279 filling the reservoir needle 78 pairing with the diabetes manager 75 removing temporarily 266 starting 83 stopping 83 N Note 94 O Offset time 131 142 363 P Pairing code 59 76 Pen mode see Injection mode PIN 41 PIN unlock code see PIN Pump base 6 59 replacing 193 warning limit for remaining running time 223 Pump data...

Page 379: ... 242 activating 243 turning off 242 Screen Lock 31 Service Centre see Customer Support and Service Centre Setup wizard 39 Shortcuts 18 Signals see Tone Snack size 131 142 361 Standard deviation 208 214 338 361 Standard week 208 Standby 40 Start 83 Startup process see Setup wizard Status screen 16 272 Stop 83 361 System components see Components T Target range 130 setting 134 TBR data 217 Temporary...

Page 380: ...dose 218 Travelling 247 Trend graph 203 Troubleshooting 293 313 causes of control tests with errors 289 causes of implausible test results 102 checking the system functions 290 control test 283 messages 293 V Vibration 234 236 Volume 235 W Warning limits 222 275 automatic off 225 hyperglycaemia 46 222 hypoglycaemia 46 223 remaining time of pump base 223 reservoir level 224 Warnings 296 man_0786636...

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