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Accu-Chek Solo Скачать руководство пользователя страница 9

1

What is the Purpose of the Micropump System?

The micropump system can support you in calculating the
recommended insulin or carbohydrate amounts based on your
blood glucose values and your personal data. The micropump
system can measure your blood glucose values, record and
represent the delivered insulin and carbohydrate amounts
consumed, as well as collect and display information for
evaluation purposes.

The micropump system can be used with the following U100
insulin types: Humalog

®

, NovoLog

®

, NovoRapid

®

, Apidra

®

or

Insuman

®

Infusat. The exact insulin type for treating your

diabetes mellitus will be prescribed by your healthcare team.

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 glucose in fresh, capillary
blood.

The micropump system is intended to be used by insulin-
dependent persons with diabetes mellitus. It is intended for
personal use only and may only be used by one and the same
person. The micropump system may only be used after having
been prescribed by a healthcare professional.

Therapy using the micropump system may only be started after
completion of the required training from a qualified instructor.
Users under the age of 12 should only use the micropump
system with the support of a trained adult.

The micropump system can be used by persons with diabetes
either on their own or with the support of a healthcare
professional or a trained individual. It is intended for persons with
diabetes who are at least 2 years of age.

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Содержание Solo

Страница 1: ...ting Up the Micropump System 31 3 1 Recharging the Battery 31 3 2 Setting Up the System 36 4 Putting the Micropump Into Operation 57 4 1 Overview 57 4 2 Recommended Infusion Sites 61 5 Testing Your Blood Glucose 85 5 1 Checking the Unit of Measurement 85 5 2 Performing a Blood Glucose Test 86 5 3 Adding Information 91 5 4 Evaluating Test Results 96 6 Delivering a Bolus 103 6 1 Manual Bolus Deliver...

Страница 2: ...se 187 10 My Data 191 10 1 Overview 191 10 2 Logbook 191 10 3 Trend Graph 198 10 4 Standard Week 203 10 5 Target Range 206 10 6 BG Averages Table 209 11 Changing Settings 211 11 1 Making Settings 212 11 2 Travelling and Flight Mode 237 12 Reminders 241 12 1 Types of Reminders 242 12 2 Programming Reminders 243 12 3 Deleting Reminders 251 12 4 Issuing Reminders 252 13 Injection Therapy Mode 253 13 ...

Страница 3: ...313 16 4 Infusion Assembly 317 16 5 Technical Data of the Insertion Device 318 17 Symbols Abbreviations Signals 319 17 1 Symbols 319 17 2 Abbreviations 322 17 3 Signals 324 18 Appendix 325 18 1 Guarantee 325 18 2 Licence Information 325 18 3 Customer Support and Service Centre 326 18 4 Supplies and Accessories 327 18 5 Disposing of the Micropump System 328 18 6 Bolus Calculation 329 19 Glossary 33...

Страница 4: ...mponents 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 teams 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 contact the Customer Support and ...

Страница 5: ...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 good therapy and fo...

Страница 6: ...he following example Step number within a sequence of actions Handling instruction Texts in blue or purple font are texts that are shown on the display These can include commands menus or list elements Display on the diabetes manager screen Tap Carbohydrates Handling instructions with display images Instructions referring to displays on the diabetes manager screen are shown as in the following exa...

Страница 7: ...ng steps In the Main menu tap the Settings menu and then tap Time blocks The blue or purple dot on the displays means Tap the display element highlighted by the dot In the main menu tap the Settings menu In the Settings menu tap the Time Blocks item Info j j The screen displays in this User s Manual can differ slightly from the displays on the diabetes manager screen j j Units figures and settings...

Страница 8: ...pricker 1 j j Lancet drums for finger pricker 2 j j Instructions for use Not included but necessary for using the micropump system j j Accu Chek Solo reservoir assemblies j j Accu Chek Solo cannula assemblies and Accu Chek Solo micropump holders Supplies Only use supplies from Roche Note To perform blood glucose tests and control tests with the Accu Chek Aviva Solo diabetes manager you need the Ac...

Страница 9: ...ous continuous delivery of rapid acting U100 insulin with variable delivery quantities and for the quantitative determination of blood glucose in fresh capillary blood The micropump system is intended to be used by insulin dependent persons with diabetes mellitus It is intended for personal use only and may only be used by one and the same person The micropump system may only be used after having ...

Страница 10: ...ness j j People who are exposed to high ambient temperatures see chapter Technical Data 1 3 Risks and Benefits Talk to your healthcare team about the benefits and potential risks that are associated with using the micropump system To ensure that insulin pump therapy is safe and successful you must actively take part in the therapy test your blood glucose values regularly calculate carbohydrate int...

Страница 11: ... caps or similar objects are swallowed j j Do not make any changes to the design of the micropump system wWARNING j j Check your blood glucose level at least four times a day j j Used devices and supplies carry a risk of infection Dispose of used system components according to local regulations j j Having the time and date set precisely is essential in order for your micropump system to function p...

Страница 12: ...oth wireless technology The diabetes manager can display important system messages such as information warnings maintenance and error messages 1 5 Components of the Micropump System Accu Chek Solo micropump system The Accu Chek Solo micropump system is a system that primarily consists of a tubeless micropump and a diabetes manager which also serves as a remote control The interactive displays on t...

Страница 13: ... 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 micropump holder The Accu Chek Solo micropump holder is a self adhesive plate 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 inser...

Страница 14: ...per hour j j 5 basal rate profiles for different daily routines j j Up to 5 Temporary Basal Rates from 0 to 250 j j Functional support when temporarily using a syringe or pen Support for therapy decisions j j Built in bolus advice feature j j Visual representation of therapy trends and logbook features j j Interface to common data management software of different providers on the PC Assisted setup...

Страница 15: ...shower or bath diving or going for a swim Place the protective caps on the cannula support of the infusion assembly yellow protective cap and on the opening with the reservoir needle grey protective cap if you are not using the micropump temporarily Exercise You can wear the micropump during a variety of physical activities Do not wear the pump for sports that involve frequent high impact bodily c...

Страница 16: ...ome airlines and governments do not permit the use of wireless radio devices during flight In these situations you can activate flight mode Flight mode enables the micropump system to comply with these regulations Communication between micropump 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 eac...

Страница 17: ...a defibrillator was used on a person wearing the micropump system this may cause the micropump system to malfunction Remove the micropump system wWARNING j j Do not use the micropump system close to sources of strong electromagnetic radiation and ionizing radiation Strong electromagnetic fields for example from radar or antenna installations high voltage sources X Ray sources magnetic resonance an...

Страница 18: ...10 What is the Purpose of the Micropump System man_07866364001_A_en indb 10 28 07 2017 12 15 45 ...

Страница 19: ...tuations The diabetes manager communicates with the 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 environm...

Страница 20: ...1 2 4 5 6 8 9 7 3 A B C 12 Getting to Know the Micropump System man_07866364001_A_en indb 12 28 07 2017 12 15 46 ...

Страница 21: ...ling up the diabetes manager menus and displaying information 7 Function buttons Buttons 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 for scanni...

Страница 22: ...on on blood glucose 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 application e g pump therapy or injection therapy other contents and symbols are displayed 14 Getting to Know the Micropump System man_07866364001_A_en indb 14 28 07 2017 12 15 46 ...

Страница 23: ...tive 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 the units of insulin available in the reservoir Name Description 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 b...

Страница 24: ...BR 2 2 2 Shortcuts on the Status screen The touch sensitive areas on the Status screen allow you to quickly access important menus and features When you tap the areas the corresponding menus or features are opened 16 Getting to Know the Micropump System man_07866364001_A_en indb 16 28 07 2017 12 15 46 ...

Страница 25: ...ction therapy other menus can be displayed Name Description 1 Menu Tap the menu icon to open the desired menu or turn on the desired feature 2 Menu selection Provides access to menus and submenus as well as direct access to individual features 3 Add data Tap this button to add further data to the logbook for example time of test 4 Status screen Tap this button to display the Status screen 2 17 Mai...

Страница 26: ... interrupted Flight mode Is displayed when flight mode is turned on No acoustic signal Is displayed when tones are turned off Temperature Is displayed when the temperature of the diabetes manager is outside the temperature range allowed for performing blood glucose tests Signals turned off Is displayed when signals for warnings are turned off for a certain period of time Vibration Is displayed whe...

Страница 27: ...upt basal rate Test blood glucose perform control test Replace system components infusion assembly reservoir pump base View or change settings view system information switch therapy mode Display or edit logbook data Menu icon Description Connect diabetes manager to PC in order to transfer data Turn flight mode on or off Set signals Watch Help videos read User s Manual 2 19 Main Menu man_0786636400...

Страница 28: ...om 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 Basal rate data Logbook entries Total daily dose Sliding pane 20 Getting to Know the Micropump System man_07866...

Страница 29: ...and backwards or to go to the Status screen Button Function Back navigation button Go back to the previous display within the process step Status screen navigation button Switch to the Status screen Next navigation button 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 some menus and when system messages are d...

Страница 30: ...een 2 5 3 Entries There are various methods 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 22 Getting to Know the Micropump System man_07866364001_A_en indb 22 28 07 2017 12 15 48...

Страница 31: ... a feature on or off Inactive function buttons and switches are greyed out Tap the element you want to select The background changes from dark to light Not selected Next Tap the switch to turn the feature on Tapping the same switch again turns the feature off Status screen Add data Status screen Add data 2 23 Navigation and Operation man_07866364001_A_en indb 23 28 07 2017 12 15 49 ...

Страница 32: ...d 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 Tap Save to save your selection 24 Getting to Know the Micropump System man_07866364001_A_en in...

Страница 33: ... 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 25 Navigation and Operation man_07866364001_A_en indb 25 28 07 2017 12 15 50 ...

Страница 34: ...p 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 26 Getting to Know the Micropump System man_07866364001_A_en indb 26 28 07 2017 12 15 50 ...

Страница 35: ...splay 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 for example for carbohydrates can be set using the minus plus buttons or be entered by means of the numeric keypad Back arrow Deletes the entered data one character at a time 2 27 Navigation and Operation man_07866364001_A_en indb 27 28...

Страница 36: ...alue 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 an...

Страница 37: ...voir 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 display that follows to unlock the screen of the diabetes manager You have the option of changing the settings in the menu Settings Screen lock...

Страница 38: ...30 Getting to Know the Micropump System man_07866364001_A_en indb 30 28 07 2017 12 15 51 ...

Страница 39: ... using the USB connector on a PC may take longer Note j j While the diabetes manager is being charged you cannot perform any blood glucose tests j j Recharge the battery regularly so that it does not become fully drained Keeping the diabetes manager plugged in for a longer period to charge does not harm the battery j j Check regularly whether the time and date of the diabetes manager are set corre...

Страница 40: ...nd the minus sign on the rechargeable battery must match the respective symbols in the battery compartment Close the battery compartment by pushing the battery door in the direction of the arrow until it clicks into place 2 Open the battery compartment by pushing the battery door up in the direction of the arrow 3 1 1 Inserting the Battery into the Diabetes Manager man_07866364001_A_en indb 32 28 ...

Страница 41: ...y Using a Wall Socket Note The blue LED lights up to indicate that the battery is being charged If the rechargeable battery of the diabetes manager has been run right down it may take up to 15 minutes until the blue LED of the diabetes manager lights up If the LED does not light up after 15 minutes proceed as follows Disconnect the charger from the diabetes manager Wait for a short time Reconnect ...

Страница 42: ...port on your computer 3 1 3 Charging the Battery Using a Computer 4 The Status screen or Main menu displays the symbol in the status bar It indicates that the battery is being charged When the battery is fully charged the symbol is displayed in the status bar You can remove the charger from the wall socket and the USB cable from the diabetes manager man_07866364001_A_en indb 34 28 07 2017 12 15 54...

Страница 43: ...een for 3 seconds Note j j The computer must usually be turned on in order for the battery to be charged With some PC models the computer must not be in sleep or standby mode if you want to charge the battery j j The USB port on a PC that is suitable for charging is often marked with a lightning symbol j j If the battery level of the diabetes manager is very low the screen is black at first j j If...

Страница 44: ...cose The setup wizard is displayed every time you turn the diabetes manager on until you complete the setup If you do not want to set up bolus advice during initial setup of the micropump system you can do so at a later point in time Note Check whether the settings you made match your requirements and the specifications of your healthcare professional wWARNING j j Discuss your individual settings ...

Страница 45: ...n the screen Tap this display to continue setting up the system 1 2 Press and hold the power button on the top of the diabetes manager until the diabetes manager turns on The diabetes manager vibrates issues a signal and the signal LED lights up The start display appears briefly Turning on the diabetes manager Caching the setup man_07866364001_A_en indb 37 28 07 2017 12 15 54 ...

Страница 46: ...l the list upwards to view additional languages Tap Save Setting the language Entering the PIN 2 Enter the PIN a second time Tap Save 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 Example of a PIN unlock code GW0000062 Diabetes Manager 12345678 PI...

Страница 47: ...ode 1 Tap the Setup mode you want to use Note If you tapped Manual setup proceed with the section Time and date settings If you tapped Set up on PC proceed with the section Configuration on the PC man_07866364001_A_en indb 39 28 07 2017 12 15 55 ...

Страница 48: ...lways displayed 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 23 Jun 2017 man_07866364001_A_en indb 40 28 07 2017 12 15 56 ...

Страница 49: ...Up the System 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 Save man_07866364001_A_en indb 41 28 07 2017 12 15 57 ...

Страница 50: ...eld 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 Save 10 Once you have entered all settings for time and date tap Save man_07866364001_A_en indb 42 28 07 2017 12 15 57 ...

Страница 51: ... 1 gram 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 Subsequent changes to the carbohydrate unit can only be made with the Accu Chek 360 configuration software man_07866364001_A_en indb 43 28 07 2017 12 15...

Страница 52: ...ou do not want to change the warning limits tap Done Setting warning limits You can set warning limits for hyperglycaemia hyper and hypoglycaemia hypo 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 Save man_07866364001_A_en indb 44 28 07...

Страница 53: ...ower warning limit Tap Save Tap Lower warning limit If you want to set up bolus advice now tap Yes In Chapter 7 Setting Up Bolus Advice you will find the explanations on and steps for setting up this feature If you do not want to set up bolus advice now tap No 6 man_07866364001_A_en indb 45 28 07 2017 12 15 59 ...

Страница 54: ...me and then End time wWARNING Make sure that you enter carbohydrates and health events correctly when you set up bolus advice Incorrect settings may lead to wrong bolus recommendations 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 gluco...

Страница 55: ...3 47 Setting Up the System 3 5 4 Use and to set the start time Tap Save Tap Done Use and to set the end time Tap Save 6 Tap Upper limit value man_07866364001_A_en indb 47 28 07 2017 12 16 00 ...

Страница 56: ...ing Up the Micropump System 8 7 9 Tap Lower limit value Use and to set the upper limit value Tap Save Use and to set the lower limit value Tap Save 10 Tap Done man_07866364001_A_en indb 48 28 07 2017 12 16 01 ...

Страница 57: ... desired 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_A_en indb 49 28 07 2017 12 16 02 ...

Страница 58: ...n requirement over up to 24 time blocks results in the basal rate profile Insulin delivery U h Hourly basal rate Time Example Basal rate profile for 18U 24hours Tap OK to set up a basal rate profile The button is deactivated 1 Note The factory settings provide 24 time blocks with one hour each The first time block starts with the start time 00 00 and ends at 01 00 The last time block starts at 23 ...

Страница 59: ...e 1 if you want to change the name of the profile Enter a name for the basal rate profile using the keyboard Tap Done 2 3 Use and to set the End time for the first time block Tap Save Define the end time for the first time block To do so tap the top entry field in the End column 4 5 man_07866364001_A_en indb 51 28 07 2017 12 16 03 ...

Страница 60: ...time block To do so tap the top entry field in the U h column 6 7 Repeat Steps 4 to 7 for each time block you want to edit Scroll the screen upwards or downwards 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 Save 8 man_07866364001_A_en indb 52 28 07 2017 12 16 03 ...

Страница 61: ... the System Next you must prepare the micropump Tap OK to confirm the message and see Chapter 4 to read how to prepare the micropump when using it for the first time 9 man_07866364001_A_en indb 53 28 07 2017 12 16 04 ...

Страница 62: ...report to be exchanged with your healthcare team j j Copying device settings j j Communication via USB connection j j Setting micropump options j j Easy navigation due to a clearly structured user interface The configuration software can be downloaded from the following web address on the Internet www com Refer to the configuration software for instructions for use For more information contact you...

Страница 63: ...tablishes the data connection to the PC This display shows that data connection between the diabetes manager and the PC was successfully established You can now use the configuration software Continue setting up the diabetes manager on the PC Configuration on the PC Note For more information on Set up on PC see the User s Manual of the Accu Chek 360 configuration software man_07866364001_A_en indb...

Страница 64: ...56 Setting Up the Micropump System man_07866364001_A_en indb 56 28 07 2017 12 16 04 ...

Страница 65: ...r a clean cloth The following steps are necessary to put the micropump into operation j j Use the insertion device to attach the micropump 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 micropump holder j j Star...

Страница 66: ...m for battery Piston rod Opening for safety release of the insertion device Opening for cannula with cannula support Soft Teflon cannula Introducer needle Handling aid Cannula casing Flap for detaching the micropump Reservoir assembly Infusion assembly Protective cap for infusion assembly Protective cap for reservoir needle man_07866364001_A_en indb 58 28 07 2017 12 16 06 ...

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