FCC ID: VWI-GW Accu-Chek Solo micropump

Contents 1 What is the Purpose of the Micropump System?

Intended Use 1.1 1.2 Contraindications 1.3 Risks and Benefits 1.4 General Warnings 1.5 Components of the Micropump System 1.6 Characteristics of the Micropump System 1.7 Using the Micropump System in Daily Life Getting to Know the Micropump System 2 2.1 Diabetes manager overview 2.2 Status Screen 2.3 Main Menu 2.4 2.5 Navigation and Operation Information Screen Setting Up the Micropump System 3 3.1 Recharging the Battery 3.2 Setting Up the System Putting the Micropump Into Operation 4 4.1 Overview 4.2 Recommended Infusion Sites 5 Testing Your Blood Glucose 5.1 Checking the Unit of Measurement 5.2 Performing a Blood Glucose Test 5.3 Adding Information 5.4 Evaluating Test Results 6 Delivering a Bolus 6.1 Manual Bolus Delivery 6.2 Bolus Input Display 6.3 Bolus Types 6.4 Programming a Bolus 6.5 Quick Bolus 6.6 Delivering the Bolus with a Pen or Syringe 6.7 Cancelling a Bolus 6.8 Delaying Bolus Delivery 57 57 61 85 85 86 91 96 103 103 104 105 107 117 121 123 126 1 1 2 2 3 4 6 7 11 11 14 17 20 21 31 31 36 man_07866364001_A_en.indb 1 28.07.2017 12:15:42 Bolus Advice 7 7.1 Overview 7.2 Setting Up Bolus Advice 7.3 Using Bolus Advice 7.4 Turning Off Bolus Advice 8 Basal Rate Profiles and Temporary BasalRates 8.1 Basal Rate Profiles 8.2 Creating and Editing a Basal Rate Profile 8.3 Temporary Basal Rates 8.4 Creating and Editing a TBR Replacing System Components 9 9.1 Starting the Replacement 9.2 Replacing the Infusion Assembly 9.3 Replacing the Reservoir 9.4 Replacing the Pump Base 10 My Data 10.1 Overview 10.2 Logbook 10.3 Trend Graph 129 129 132 154 162 163 163 164 170 171 179 180 180 184 187 191 191 191 198 10.4 Standard Week 10.5 Target Range 10.6 BG Averages Table 11 Changing Settings 11.1 Making Settings 11.2 Travelling and Flight Mode 12 Reminders 12.1 Types of Reminders 12.2 Programming Reminders 12.3 Deleting Reminders 12.4 Issuing Reminders Injection Therapy Mode 13 13.1 Removing the Micropump Temporarily 13.2 Injection Therapy Displays 13.3 Injection Therapy Settings 14 Care and Maintenance 14.1 Cleaning the Micropump System 14.2 Control Tests 14.3 Checking the System Functions 203 206 209 211 212 237 241 242 243 251 252 253 254 259 265 267 267 272 280 man_07866364001_A_en.indb 2 28.07.2017 12:15:42 18.4 Supplies and Accessories 18.5 Disposing of the Micropump System 18.6 Bolus Calculation 19 Glossary 20 Index 327 328 329 333 341 15 Messages and Troubleshooting 15.1 Information Messages 15.2 Warning Messages 15.3 Maintenance Messages 15.4 Error Messages 15.5 Troubleshooting 16 Technical Data 16.1 Micropump System 16.2 Diabetes Manager 16.3 Micropump 16.4 Infusion Assembly 16.5 Technical Data of the Insertion Device 17 Symbols, Abbreviations, Signals 17.1 Symbols 17.2 Abbreviations 17.3 Signals 18 Appendix 18.1 Guarantee 18.2 Licence Information 18.3 Customer Support and Service Centre 283 285 286 294 301 303 309 309 310 313 317 318 319 319 322 324 325 325 325 326 man_07866364001_A_en.indb 3 28.07.2017 12:15:42 Also consult the instructions for use enclosed with the components of the Accu-Chek Solo micropump system. You can call up an electronic version of this Users Manual from the main menu of the diabetes manager under the Help menu. About this Users Manual Read this Users Manual carefully before using your Accu-Chek Solo micropump system for the first time. This Users Manual provides you with the information you need to safely operate the micropump system. In addition, this Users Manual provides you with the information you need for maintenance and troubleshooting. You must be familiar with the displays on the screen, the signals of the diabetes manager and micropump as well as the functionality and characteristics of the system components, in order to be able to use the micropump system properly and reliably. This Users Manual is intended for people with diabetes, their caregivers, for parents whose children have diabetes as well as for healthcare teams. This Users 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 Service Centre (see Chapter 18). IV man_07866364001_A_en.indb 4 28.07.2017 12:15:42 The following information is highlighted in a special way:

wWARNING A warning must be heeded because it indicates a risk of injury or of damage to your health or the health of others. Not heeding the warnings can lead to life-threatening situations. Note A note contains helpful information and tips to help you get the most out of using the micropump system. Example An example shows you how a feature could be used in an everyday situation. Note that medical- or therapy-related details are provided for illustration purposes only, and are not intended to match your personal medical needs. 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 good therapy and for fully benefitting from the micropump system. Read these chapters before using the respective features. The following abbreviations are used in this Users Manual:

j Diabetes manager is shortened to DM. j Blood glucose is shortened to BG. j Micropump is shortened to MP. j Temporary basal rate is shortened to TBR. For more abbreviations, see Chapter 17. man_07866364001_A_en.indb 5 V 28.07.2017 12:15:42 Illustrated handling instructions Handling instructions with display images Instructions for handling system components are shown as in the following example:

Instructions referring to displays on the diabetes manager screen are shown as in the following example:

Step number within a sequence of actions Step number within a sequence of actions 1 2 Illustration of instruction Touch the blood drop to the front yellow edge of the test strip. Handling instruction Tap Carbohydrates. VI Display on the diabetes manager screen Handling instruction Texts in blue or purple font are texts that are shown on the display. These can include commands, menus or list elements. man_07866364001_A_en.indb 6 28.07.2017 12:15:42 Quick navigation in the Users Manual 1 2 Some handling instructions in this Users Manual are summarised into a quick navigation path. At the beginning of some chapters or sections, for example, you will find the following information:

Main menu > Settings > Time blocks This quick navigation path represents the following steps: In the Main menu tap the Settings menu and then tap Time blocks. The blue display element highlighted by the dot. or purple dot on the displays means Tap the In the main menu, tap the Settings menu. In the Settings menu, tap the Time Blocks item. Info j The screen displays in this Users Manual can differ slightly from the displays on the diabetes manager screen. j Units, figures and settings on the screen displays in this Users Manual are only examples. VII 28.07.2017 12:15:43 man_07866364001_A_en.indb 7 Scope of delivery The starter kit contains the following system components:

j Accu-Chek Solo pump base (2) j Accu-Chek Aviva Solo diabetes manager (1) j Rechargeable battery for the Accu-Chek Aviva Solo diabetes manager (1) j Accu-Chek Solo insertion device (1) j Charger with plug (1) j USB cable (1) j Accu-Chek Solo carry case (1) j Finger pricker (1) j Lancet drums for finger pricker (2) j Instructions for use Pump base Diabetes manager Not included, but necessary for using the micropump system:

j Accu-Chek Solo reservoir assemblies j Accu-Chek Solo cannula assemblies and Accu-Chek Solo micropump holders Supplies Only use supplies from Roche. VIII Note To perform blood glucose tests and control tests with the Accu-Chek Aviva Solo diabetes manager, you need the Accu-Chek Aviva test strips and the Accu-Chek Aviva control solution. man_07866364001_A_en.indb 8 28.07.2017 12:15:43 1 What is the Purpose of the Micropump System?

1 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. man_07866364001_A_en.indb 1 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 28.07.2017 12:15:43 What is the Purpose of the Micropump System?

1.2 Contraindications 1.3 Risks and Benefits Your healthcare professional must decide whether insulin pump therapy is suitable for the treatment of your diabetes mellitus. Talk to your healthcare team about the benefits and potential risks that are associated with using the micropump system. Continuous Subcutaneous Insulin Infusion (CSII) with the micropump system is not recommended or only recommended with limitations for the following groups of people:

j People who are not able or willing to perform at least 4 blood 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 intake and monitor the micropump functions regularly. glucose tests per day. j People who are not able to be in regular contact with their healthcare team. 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 People who cannot be relied upon due to drug addiction, substance abuse or mental illness. j People who are exposed to high ambient temperatures

(see chapter Technical Data). In case of improper use of the micropump system or non-

compliance with your healthcare professionals 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 bolus advice defined therein. 2 man_07866364001_A_en.indb 2 28.07.2017 12:15:43 General Warnings 1 1.4 General Warnings wWARNING j The micropump system may only be used by a single person for insulin therapy. All objects which can come into contact with human blood carry a potential risk of infection. There is a risk of infections being transmitted if the same micropump system is used by other people, even by family members, or if healthcare professionals use the same micropump system for insulin therapy or blood glucose tests for different people. wWARNING j Check your blood glucose level at least four times a day. j Used devices and supplies carry a risk of infection. Dispose of used system components according to local regulations. j Having the time and date set precisely is essential in order for your micropump system to function properly. A wrong time setting can have serious consequences. j Always keep alternative therapy supplies at hand (for example, a blood glucose meter or pen) in case the micropump system stops working properly. j Only use the micropump to deliver rapid-acting U100 j Do not use or store the micropump system outside the insulin. j Do not change your therapy without consulting your healthcare team first. j Keep all system components away from small children or vulnerable persons. There is a risk of suffocation if small parts (e.g. covers, caps, or similar objects) are swallowed. j Do not make any changes to the design of the micropump system. permitted ambient conditions. This may lead to hyperglycaemia or hypoglycaemia. j Use sterile supplies only once and only if the use by date has not expired. man_07866364001_A_en.indb 3 3 28.07.2017 12:15:43 What is the Purpose of the Micropump System?

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 the diabetes manager screen, help you to make individual settings and control the micropump. Accu-Chek Solo pump base The 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. Accu-Chek Aviva Solo diabetes manager The Accu-Chek Aviva Solo diabetes manager is used to configure and control the micropump. It has an LCD screen and communicates with the micropump via Bluetooth wireless technology. The diabetes manager can display important system messages such as information, warnings, maintenance and error messages. 4 man_07866364001_A_en.indb 4 28.07.2017 12:15:44 Accu-Chek Solo reservoir Accu-Chek Solo micropump holder Components of the Micropump System 1 The Accu-Chek Solo reservoir is the second part of the micropump in addition to the pump base. The reservoir is a sterile container for holding the insulin that the micropump delivers to the body. The reservoir has a zinc-air battery, which serves as an energy source to the micropump. 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 cannula assembly Accu-Chek Solo insertion device The Accu-Chek Solo cannula assembly consists of the cannula casing and the sterile cannula. It creates a connection between the micropump and the body. The Accu-Chek Solo cannula assembly is available with cannula lengths of 6mm (orange) or 9mm (blue). The Accu-Chek Solo insertion device is used to attach the infusion assembly (micropump holder and cannula) to the body and insert the cannula into the subcutaneous tissue. man_07866364001_A_en.indb 5 5 28.07.2017 12:15:45 What is the Purpose of the Micropump System?

1.6 Characteristics of the Micropump System Tubeless insulin pump j Small, light and removable micropump (28g) j Transparent reservoir (up to 200U), usable for approx. 4 days j Soft Teflon cannula with a length of 6mm or 9mm j Can be worn at different sites directly on the body j Filling aid for easy and controlled filling j Can be used with rapid-acting U100 insulin from different manufacturers Convenient handling with the help of the diabetes manager j Controls the micropump system via touchscreen and Bluetooth wireless technology j Direct access to important features, such as bolus, basal rates, and blood glucose values, via the Status screen j Preview of therapy and system events by means of the information screen j Adjustable user menus in several languages Customised bolus and basal features j Bolus delivery (up to 50U) with diabetes manager or directly on the micropump j Selectable bolus types: standard, extended, multiwave j Basal rates from 0.1U per hour up to 25U per hour j 5 basal rate profiles for different daily routines j Up to 5 Temporary Basal Rates from 0 to 250%

6 j Functional support when temporarily using a syringe or pen Support for therapy decisions j Built-in bolus advice feature j Visual representation of therapy trends and logbook features j Interface to common data management software of different providers on the PC Assisted setup and application j Micropump system is set up using a setup wizard j Guided setup of basal rate profiles and bolus advice feature j Guided replacement of system components j Electronic Users Manual and videos explaining handling steps on the diabetes manager Comfort and safety features j Built-in blood glucose meter in the diabetes manager j Illumination for test strip slot and blood application area j Rechargeable, long-life battery in the diabetes manager j Optional key lock with PIN j Programmable volume setting and vibration mode for different environments j Built-in self-tests and automatic detection of malfunctions j Information on warnings and required maintenance activities man_07866364001_A_en.indb 6 28.07.2017 12:15:45 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 you should 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 alternative therapy supplies at hand for your own safety. Note The micropump system is supplied with two pump bases. Order a new pump base in time before the operating life of the first pump base expires so that you always have one in reserve. Showering, bathing, swimming, diving Protect the diabetes manager from moisture and water. The micropump is splashproof, but it must not be immersed in liquids. Therefore, remove the micropump from the pump holder before taking a 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 man_07866364001_A_en.indb 7 Using the Micropump System in Daily Life 1 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 contact, such as martial arts, football or hockey. The micropump could suffer damage by being hit or kicked or if it is hit by a ball. Sleeping Place the diabetes manager within reach so that you can hear reminders and system messages. We recommend that you recharge the diabetes manager when you go to bed. Temperature Do not expose the micropump to direct sunlight, UV radiation or heat. The operating temperature of the micropump is between

+5C and +40C. In temperatures outside this range, the insulin contained in the reservoir could damage the micropump system. 7 28.07.2017 12:15:45 What is the Purpose of the Micropump System?

Air pressure and altitude Rapid and significant changes in air pressure or temperature can influence insulin delivery, especially if there are air bubbles in the reservoir. Such changes can occur, for example, when you are j in an aeroplane, especially during take-off and landing j doing sports 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 an alternative therapy method. Do not use the micropump system in altitudes above 3,000metres above sea level. Travelling and flights Before travelling, ask your healthcare team about any special preparations you need to make. Take sufficient supplies with you for blood glucose testing and for your micropump (consumables, test strips, insulin and so on), and find out where you can obtain supplies while you are travelling. We recommend that you always have the quick reference instructions and emergency card (SOS) with you, which can be detached from the cover of this Users Manual. Some 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 8 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 each other. The distance between the diabetes manager and the micropump should not be more than 10metres. 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 (see chapter 15). Communication is automatically re-established when the cause of the interruption no longer exists. As long as communication is interrupted, the new data is saved on the micropump and the diabetes manager. Once communication between the pump and the diabetes manager has been re-established, the pump automatically transfers your saved data to the diabetes manager. Distance from electrical devices There are many devices that emit electromagnetic radiation, for man_07866364001_A_en.indb 8 28.07.2017 12:15:45 Using the Micropump System in Daily Life 1 example, mobile phones. It cannot be completely ruled out that a device of this kind could affect your micropump system. It is therefore recommended that you keep your micropump system at least 30cm away from these devices while they are turned on. Remove the micropump from your body before you undergo examinations or treatments such as magnetic resonance imaging

(MRI), computed tomography (CT), X-rays or ultrasound, or before you enter areas with strong electromagnetic fields. The micropump system is not protected against effects which may occur when using a defibrillator on a person. If 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 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 and computed tomography could interfere with the micropump system. Stop the micropump and remove it from your body before you enter areas with electromagnetic or ionizing radiation. j Do not use or store the micropump system in environmental conditions other than those for which it is intended. man_07866364001_A_en.indb 9 9 28.07.2017 12:15:45 What is the Purpose of the Micropump System?

10 man_07866364001_A_en.indb 10 28.07.2017 12:15:45 2 Getting to Know the Micropump System 2 2.1 Diabetes manager overview The Accu-Chek Aviva Solo diabetes manager is a remote control with an integrated blood glucose meter that is used to control the micropump. The diabetes manager supports you in your diabetes treatment and is only suitable for self-testing. The diabetes manager has a coloured LCD touchscreen. You can use the diabetes manager to program the delivery of basal insulin and boluses. The diabetes manager can calculate bolus advice tailored to your individual needs and situations. 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 Always have the diabetes manager with you. j A rechargeable battery supplies power to the diabetes manager. Charge the battery on a regular basis. j If the environment you are in has a high noise level, you may not hear the system messages. Pay attention to the displays and signals on the diabetes manager to make sure that the micropump system is functioning properly. man_07866364001_A_en.indb 11 11 28.07.2017 12:15:45 Getting to Know the Micropump System 1 2 4 5 3 6 7 8 9 B C 12 A man_07866364001_A_en.indb 12 28.07.2017 12:15:46 Diabetes manager overview 2 Name Description Power button Turns the diabetes manager on or off. Lanyard eyelet Used to attach a lanyard. Earphone socket Socket for connecting passive earphones. LED LED to signalise error, maintenance and warning messages as well as reminders. 1 2 3 4 5 Micro USB connector Socket for connecting the USB cable (micro-B plug) in order to recharge the battery or establish a connection to a PC. 6 7 8 9 10 11 12 Screen LCD touchscreen for calling up the diabetes manager menus and displaying information. Function buttons Buttons for operating context-sensitive functions. Navigation buttons Navigation controls for moving between menus and process steps. Insulin button Button for confirming a previously set insulin delivery. Test strip slot For inserting test strips for blood glucose tests and control tests. Camera Used for scanning the pairing code on the pump base to pair the micropump and the diabetes manager. Battery door Removable cover for the battery compartment. man_07866364001_A_en.indb 13 13 28.07.2017 12:15:46 Getting to Know the Micropump System 2.2 Status Screen 2.2.1 Overview On the Status screen, you can see the most important, current and most common therapy information 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. 1 2 3 4 5 6 7 8 9 A 14 man_07866364001_A_en.indb 14 28.07.2017 12:15:46 Name Description Name Description Status Screen 2 7 8 9 10 Remaining bolus time Shows the amount of time remaining of an extended or multiwave bolus. Bolus progress bar Shows the amount and duration of the active bolus in the form of a bar. Add data Tap this item to add further data to the logbook (for example, time of test). Tap this button to cancel one or all active boluses. Blood glucose result Basal rate Bolus New bolus Main menu Shows the most recent blood glucose result with the time and date of the test. The background colour indicates whether the test result falls within the target range (see also Test Result Colour Coding in chapter 5). Shows the active basal rate profile with the current basal rate. If a Temporary Basal Rate is active, the corresponding percentage is also displayed. Shows the active bolus type and the remaining insulin units. Tap New bolus or new bolus. to program a Tap this button to display the main menu. Reservoir level Shows the units of insulin available in the reservoir. 1 2 3 4 5 6 man_07866364001_A_en.indb 15 15 28.07.2017 12:15:46 Getting to Know the Micropump System 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. Logbook entries menu Basal rate menu Cancel bolus Bolus menu 16 Replace system components menu Cancel TBR man_07866364001_A_en.indb 16 28.07.2017 12:15:46 2.3 Main Menu Name Description Main Menu 2 The main menu is an overview of the most important features of the diabetes manager. From here, you can open the basic menus and features, go to the Status screen or add data. 1 Menu Tap the menu icon to open the desired menu or turn on the desired feature. Provides access to menus and submenus as well as direct access to individual features. Tap this button to add further data to the logbook (for example, time of test). Status screen Tap this button to display the Status screen. Menu selection Add data 2 3 4 2 3 Depending on the situation (for example, pump therapy or injection therapy), other menus can be displayed. 17 28.07.2017 12:15:46 1 4 man_07866364001_A_en.indb 17 Getting to Know the Micropump System The status bar at the top edge of the screen shows the current time. In addition, the following symbols may be displayed. Symbol Name Description Status of rechargeable battery Shows the current level of the rechargeable battery in the diabetes manager. No communication 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. 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 when the vibration feature is turned on. Signals are deactivated. 18 man_07866364001_A_en.indb 18 28.07.2017 12:15:46 Menus of the Main menu Menu icon Description Deliver manual bolus, use bolus advice, cancel bolus Select or set basal rate profiles, set and cancel Temporary Basal Rates (TBR) Start micropump Stop micropump (cancel bolus and TBR and interrupt 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 man_07866364001_A_en.indb 19 Main Menu 2 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 Users Manual 19 28.07.2017 12:15:47 Getting to Know the Micropump System 2.4 Information Screen The information screen is a representation of important device, status and therapy information as well as system events. When you tap the events, the respective menus with detailed information open. 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 20 Sliding pane Slide your finger from the upper screen edge downwards. The information screen is shown. Move the information screen to the top again to hide it. man_07866364001_A_en.indb 20 28.07.2017 12:15:47 2.5 Navigation and Operation 2.5.1 Navigation buttons Navigation and operation of the diabetes manager is done by means of the touchscreen and navigation buttons. You can use the navigation buttons below the screen to move forwards and backwards or to go to the Status screen. Navigation and Operation 2 The insulin button is an exception. Insulin deliveries for basal rates or a bolus that have been programmed using the diabetes manager can only be started by pressing a separate insulin button. 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 displayed, not all navigation buttons are available. If you make settings in a process step and then press the be saved. button, the settings will not man_07866364001_A_en.indb 21 21 28.07.2017 12:15:48 Getting to Know the Micropump System 2.5.2 Insulin button 2.5.3 Entries The insulin button is only used to confirm a previously set insulin delivery. When the diabetes manager is ready to deliver basal or bolus insulin, the button lights up green. 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. Example Check whether the settings for insulin delivery are correct. Press the button to start insulin delivery. 22 man_07866364001_A_en.indb 22 28.07.2017 12:15:48 Executing commands Switching a feature on or off Whenever you tap a command on the screen, the background colour changes. By tapping a switch, you can turn a feature on or off. Inactive function buttons and switches are greyed out. Navigation and Operation 2 Example Not selected Next Selected Next Example Status screen Add data Status screen Add data Tap the element you want to select. The background changes from dark to light. Tap the switch to turn the feature on. Tapping the same switch again turns the feature off. man_07866364001_A_en.indb 23 23 28.07.2017 12:15:49 Getting to Know the Micropump System Simple lists or menus Lists with checkboxes No element is preselected in simple lists or menus. You can select an element. In these lists, you can select either one or more elements simultaneously or no element. Example Example Tap the element you want to select. The background changes from light to dark. When you have selected an element, the next display appears. 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 man_07866364001_A_en.indb 24 28.07.2017 12:15:49 Navigation and Operation 2 Lists with radio buttons Editing an element In these lists, one element is always selected, for example, by the factory settings. By tapping the desired element, you can change the selection. To edit the desired element, it must be selected. Example Example Tap the element you want to select. The green dot is displayed in the circle in front of the newly selected element. Tap the element you want to edit. You can edit the element on the display that follows. man_07866364001_A_en.indb 25 25 28.07.2017 12:15:50 Getting to Know the Micropump System Scrolling lists Slider In long menus and lists, you can scroll the list to display the elements that are not visible. You can make the desired setting by moving the slider. Example Example Scroll the list upwards to view additional list elements or menus. Scroll the list downwards to view the top list elements or menus. 26 Move the slider to the desired position. man_07866364001_A_en.indb 26 28.07.2017 12:15:50 2.5.4 Entering Numbers Numeric keypad You can either use a numeric keypad to enter numbers or use the minus/plus buttons to set them. You can enter numeric values such as the carbohydrate amount using the numeric keypad. Navigation and Operation 2 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. Display field for entry Decimal point Symbol for entry using the numeric keypad Back arrow:

Deletes the entered data one character at a time Enter the desired numeric value using the numeric keypad. 27 28.07.2017 12:15:50 man_07866364001_A_en.indb 27 Getting to Know the Micropump System Minus/plus buttons 2.5.5 Entering Text and allow you to switch between entering data using the minus/plus buttons and the numeric keypad. Text is entered using a keyboard. Depending on the language, key assignments may differ. Explanation/Example Explanation/Example Symbol for entering text using the minus/plus buttons Button to decrease the value entered Display field for entry Button to increase the value entered Switches between lowercase and uppercase to increase the numeric value on the display. Tap Tap decrease the numeric value 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. to 28 Switches between a keyboard with letters and a keyboard with numbers, punctuation and special characters Enter the desired text using the letter keyboard. Deletes the entered data one character at a time Confirms the entry man_07866364001_A_en.indb 28 28.07.2017 12:15:51 2.5.6 Screen Lock Unlocking the screen Navigation and Operation 2 If the diabetes manager has been inactive for approx. 60seconds, the screen is automatically locked. You can also lock the screen by pressing the power button. A locked screen is indicated by the symbol. The lock prevents others from viewing the screen and prevents functions from being activated unintentionally on the touchscreen while you are not using the device. The last blood glucose result, the time and date, the 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 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. Swipe across the screen with your finger, starting from the symbol, until the lock symbol is outside the circle shown, then remove your finger. 29 man_07866364001_A_en.indb 29 28.07.2017 12:15:51 Getting to Know the Micropump System 30 man_07866364001_A_en.indb 30 28.07.2017 12:15:51 3 3 Setting Up the Micropump System 3.1 Recharging the Battery Before you start using the diabetes manager, you must charge the battery. wWARNING Connect the diabetes manager to a PC or charger using the USB cable. The preferred method is to use a charger and wall socket since charging takes less time this way. It takes approx. 4 hours to charge a fully drained battery using a charger that is connected to a wall socket. Charging the battery using the USB connector on a PC may take longer. Symbols for different battery levels:

low 20%

40%

60%

80%

100%

j Use only the supplied charger with the appropriate USB cable. j Use only the rechargeable battery from Roche. Note j While the diabetes manager is being charged, you cannot perform any blood glucose tests. 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 Check regularly whether the time and date of the diabetes manager are set correctly. man_07866364001_A_en.indb 31 31 28.07.2017 12:15:51 Setting Up the Micropump System 3.1.1 Inserting the Battery into the Diabetes Manager 1 2 3 4

+

Have the diabetes manager, rechargeable battery, charger and USB cable ready. Open the battery compartment by pushing the battery door up in the direction of the arrow. Place the rechargeable battery into the battery compartment of the diabetes manager. Close the battery compartment by pushing the battery door in the direction of the arrow until it clicks into place. The plus sign (+) and the minus sign (-) on the rechargeable battery must match the respective symbols in the battery compartment. 32 man_07866364001_A_en.indb 32 28.07.2017 12:15:52 3.1.2 Charging the Battery Using a Wall Socket 1 2 3 Plug the larger end (USB type A plug) of the USB cable into the USB socket of the charger. Plug the smaller end (USB Micro-B plug) of the USB cable into the USB socket of the diabetes manager. Plug the charger into a wall socket. man_07866364001_A_en.indb 33 Recharging the Battery 3 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 the charger to the diabetes manager. 33 28.07.2017 12:15:53 Setting Up the Micropump System 4 3.1.3 Charging the Battery Using a Computer 1 2 The Status screen or Main menu displays the status bar. It indicates that the battery is being charged. symbol in the symbol is displayed in When the battery is fully charged, the the status bar. You can remove the charger from the wall socket and the USB cable from the diabetes manager. 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. 34 man_07866364001_A_en.indb 34 28.07.2017 12:15:54 3 4 If the connection is successful, the diabetes manager displays the charging screen for 3seconds. On the information screen, the current status of the rechargeable battery is shown using the charging symbol and a percentage. symbol is When the battery is fully charged, the displayed. You can remove the USB cable from the diabetes manager and the PC. man_07866364001_A_en.indb 35 Recharging the Battery 3 Note 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 The USB port on a PC that is suitable for charging is often marked with a lightning symbol. j If the battery level of the diabetes manager is very low, the screen is black at first. j If you want to transfer data to the computer after connecting Connect menu in the Main menu. the USB cable, tap the 35 28.07.2017 12:15:54 Setting Up the Micropump System 3.2 Setting Up the System You can set up the diabetes manager manually, directly on the device with the help of the setup wizard, or you can use the configuration software to do so on your PC. 3.2.1 Setup Wizard The first time you turn the diabetes manager on, the setup wizard is displayed. You must complete the setup wizard before you start using the micropump or test your blood glucose. 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. wWARNING j Discuss your individual settings for insulin dose, warning limits, time blocks and bolus advice with your healthcare professional. j Wrong basal rate settings may lead to hyperglycaemia or hypoglycaemia. Note Check whether the settings you made match your requirements and the specifications of your healthcare professional. 36 man_07866364001_A_en.indb 36 28.07.2017 12:15:54 Caching the setup Turning on the diabetes manager 1 2 Setting Up the System 3 The data and settings you enter are cached at specific points during setup. If you want to resume setup after an interruption, Continue setup appears on the screen. Tap this display to continue setting up the system. 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. man_07866364001_A_en.indb 37 37 28.07.2017 12:15:54 Setting Up the Micropump System Setting the language 1 Entering the PIN 1 2 Tap the desired language. If required, scroll the list upwards to view additional languages. Tap Save. Enter a PIN (secret identification number) of your choice with 4 to 8 digits. Choose a PIN that is easy to remember. Note down the PIN and keep it in a safe place. Tap Save. Enter the PIN a second time. Tap Save. 38 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 Users Manual. Example of a PIN unlock code:

Diabetes Manager GW0000062 12345678 PIN man_07866364001_A_en.indb 38 28.07.2017 12:15:55 Setting Up the System 3 Selecting Setup mode 1 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. Tap the Setup mode you want to use. man_07866364001_A_en.indb 39 39 28.07.2017 12:15:55 Setting the time and date 1 2 Setting Up the Micropump System Time and date information Times and time periods are always displayed or entered in the following format HH:MM (HH=hours, MM=minutes). 24-hour time format 12-hour time format 01:07 16:15 01:07 am 04:15 pm HH:MM 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, 23Jun.2017. Tap Time format. Tap the desired time format. Tap Save. 40 man_07866364001_A_en.indb 40 28.07.2017 12:15:56 3 4 5 6 Setting Up the System 3 Tap Time. The hours field is selected

(dark background). Use and to set the hours. Tap the minutes field. Tap Date. to set the and Use minutes. Tap Save. man_07866364001_A_en.indb 41 41 28.07.2017 12:15:57 Setting Up the Micropump System 7 8 9 10 The day field is highlighted. Tap the month field. Tap the year field. Use and to set the day. and Use month. to set the Use and to set the year. Tap Save. Once you have entered all settings for time and date, tap Save. 42 man_07866364001_A_en.indb 42 28.07.2017 12:15:57 Setting the carbohydrate unit The diabetes manager offers the following carbohydrate units for selection:

Abbreviation Unit of measurement Gram equivalent g BE KE CC Gram Broteinheit

(bread equivalent) Kohlenhydrateinheit

(carbohydrate unit) 1gram 12grams 10grams Carbohydrate choice 15grams man_07866364001_A_en.indb 43 Setting Up the System 3 1 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. Tap the carbohydrate unit you want to set. 43 28.07.2017 12:15:58 Setting Up the Micropump System 2 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. 1 2 Tap Yes if the correct unit is displayed. If you want to change the unit, tap No. You then return to Step1. 44 The default warning limits are displayed. and Use warning limit. to set the upper Tap Upper warning limit. Tap Save. If you do not want to change the warning limits, tap Done. man_07866364001_A_en.indb 44 28.07.2017 12:15:58 3 4 5 6 Setting Up the System 3 Tap Lower warning limit. and Use warning limit. to set the lower The warning limits currently set are displayed. Tap Save. Tap Done. man_07866364001_A_en.indb 45 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. 45 28.07.2017 12:15:59 Setting Up the Micropump System Setting time blocks 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. 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. Note If you want to use bolus advice, you must set it up. 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. 46 1 2 Tap OK. Tap Start time and then End time. man_07866364001_A_en.indb 46 28.07.2017 12:16:00 3 4 5 6 Setting Up the System 3 and to set the start Use time. Use time. and to set the end Tap Done. Tap Upper limit value. Tap Save. Tap Save. man_07866364001_A_en.indb 47 47 28.07.2017 12:16:00 Setting Up the Micropump System 7 8 9 10 to set the upper Tap Lower limit value. Use and limit value. Tap Save. to set the lower Tap Done. Use and limit value. Tap Save. 48 man_07866364001_A_en.indb 48 28.07.2017 12:16:01 11 Tap OK. 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. Setting Up the System 3 12 13 Repeat the previous steps if you want to change more time blocks. Tap OK. Once you have changed all desired time blocks, tap Done. man_07866364001_A_en.indb 49 49 28.07.2017 12:16:02 Setting Up the Micropump System 3.2.2 Programming the Basal Rate Profile The aim of insulin pump therapy is to reproduce the natural biorhythm of insulin delivery of a healthy pancreas as far as possible. The basal rate covers the basal, meal-independent insulin requirement. The basal rate is specified in insulin units per hour

(U/h = Units per hour). The distribution of the basal insulin requirement over up to 24 time blocks results in the basal rate profile. 1 Example: Basal rate profile for 18 U/24 hours Insulin delivery U/h Tap OK to set up a basal rate profile. The button is deactivated. Hourly basal rate 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 23:00 and ends at 00:00. For each time block, 0U/h is set by factory default. 50 0 1 2 3 4 5 6 78 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time man_07866364001_A_en.indb 50 28.07.2017 12:16:02 2 3 4 5 Setting Up the System 3 The basal rate profile with the name Profile 1 is displayed. Enter a name for the basal rate profile using the keyboard. Define the end time for the first time block. and Use to set the End time for the first time block. Tap the element with the symbol (here: Profile 1) if you want to change the name of the profile. Tap Done. To do so, tap the top entry field in the End column. Tap Save. man_07866364001_A_en.indb 51 51 28.07.2017 12:16:03 Setting Up the Micropump System 6 7 8 Define the insulin units per hour for the first time block. and to set the Use insulin units for the first time block. To do so, tap the top entry field in the U/h column. Tap Save. 52 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. man_07866364001_A_en.indb 52 28.07.2017 12:16:03 9 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. man_07866364001_A_en.indb 53 Setting Up the System 3 53 28.07.2017 12:16:04 Setting Up the Micropump System 3.2.3 Configuration Software The configuration software can be downloaded from the following web address on the Internet:

You can use the Accu-Chek360 configuration software to set up the micropump system on the PC. You can make all settings on the monitor of your PC in a clear, graphical representation. www.###.com Features and options of the configuration software:

j Setting up basal rate profiles j Setting user-defined Temporary Basal Rates j Setting up bolus advice j Setting reminders j Reviewing and editing all settings j Printing and saving a configuration report to be exchanged with your healthcare team j Copying device settings j Communication via USB connection j Setting micropump options j Easy navigation due to a clearly structured user interface Refer to the configuration software for instructions for use. For more information, contact your Customer Support and Service Centre. Note j The current settings in the diabetes manager are replaced by the settings in the configuration software. All settings are saved in the configuration. j After completing configuration, you must restart the micropump. 54 man_07866364001_A_en.indb 54 28.07.2017 12:16:04 Configuration on the PC 1 2 3 Setting Up the System 3 Note For more information on Set up on PC, see the Users Manual of the Accu-Chek 360 configuration software. If you selected Set up on PC, connect the diabetes manager and the PC using a USB cable. Start the configuration software for setting up the diabetes manager on the PC. The diabetes manager establishes 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. man_07866364001_A_en.indb 55 55 28.07.2017 12:16:04 Setting Up the Micropump System 56 man_07866364001_A_en.indb 56 28.07.2017 12:16:04 4 Putting the Micropump Into Operation 4 4.1 Overview This chapter explains all steps necessary to prepare the micropump before using it for the first time. To put the micropump into operation, you need the following:

j Diabetes manager j Pump base j Reservoir assembly j Micropump holder and cannula assembly j Insertion device j Disinfectant or a clean cloth The following steps are necessary to put the micropump into operation:

j Use the insertion device to attach the micropump holder to thebody and insert the cannula j Fill the new reservoir with insulin j Connect the reservoir to the pump base j Pair the micropump with the diabetes manager j Fill the reservoir needle j Attach the micropump to the micropump holder j Start the basal rate man_07866364001_A_en.indb 57 Cannula assembly 6mm

(orange) Cannula assembly 9mm

(blue) Reservoir assembly Micropump holder 57 28.07.2017 12:16:05 Putting the Micropump Into Operation Infusion assembly Micropump holder Hook for attaching the micropump Opening for safety release of the insertion device Opening for cannula with cannula support Flap for detaching the micropump Handling aid Cannula casing Cannula assembly 58 Soft Teflon cannula Introducer needle Reservoir assembly Filling aid Protective film for battery Handle for piston rod Reservoir needle Piston rod Protective cap for infusion assembly Protective cap for reservoir needle man_07866364001_A_en.indb 58 28.07.2017 12:16:06

Insertion device Micropump Overview 4 Positioning aid Inserted cannula assembly Detach button Release button Priming handle Cannula assembly slot Safety release Lock Cannula opening Pump base with mounted reservoir Pairing code Notch for attaching the micropump holder Pump shield Ventilation opening Quick bolus buttons 59 28.07.2017 12:16:07 man_07866364001_A_en.indb 59 Putting the Micropump Into Operation wWARNING j The reservoir, cannula and micropump holder are intended for single use and are sterile packaged. They must not be used if their sterile packaging was previously opened or damaged or if the use by date has expired. j Check at regular intervals that the micropump holder and cannula are tightly connected to each other. Make sure that the micropump holder does not detach itself from the infusion site and that the adhesive pad is not wet. Insulin delivery may be interrupted by a loose fitting or displaced cannula. j Check your blood glucose level at least four times a day and once within a period of 1 to 3hours if the micropump was exposed to any mechanical impact. Note j The micropump holder must not be attached to sites on the body with scars, birthmarks and moles, tattoos, injuries, bruises or rashes. j Before you attach the micropump holder to the body, the infusion site must be completely dry. j A new infusion site must be at least 5cm away from the last infusion site. j If the micropump holder frequently becomes detached from the skin, consult your healthcare team to find a method that may improve adhesion to the skin. j If the infusion site becomes inflamed, replace the infusion assembly immediately and choose a new infusion site. j Check the micropump system for possible damage or leaks regularly. j Check your blood glucose level after changing the infusion assembly once within 1 to 3 hours. j Check the micropump system for damage or leaks if you can smell insulin. 60 man_07866364001_A_en.indb 60 28.07.2017 12:16:07 4.2 Recommended Infusion Sites Recommended Infusion Sites 4 Choose a suitable infusion site before inserting a new infusion assembly. Consult your healthcare team for advice. Sites with sufficient subcutaneous tissue are the most suitable. For example:

Infusion site Characteristics Abdominal region Common infusion site with good insulin absorption. Upper arm Thigh Hip, lower back, buttocks Slower insulin absorption compared to the abdominal region. Slower insulin absorption compared to the abdominal region. Slower insulin absorption compared to the abdominal region. Also suitable for physically active users or if not much subcutaneous tissue is available. Note If the infusion site becomes inflamed, replace the infusion assembly immediately and choose a new infusion site. Blue areas: Recommended infusion sites Grey areas: Possible infusion sites man_07866364001_A_en.indb 61 61 28.07.2017 12:16:07 Putting the Micropump Into Operation 4.2.1 Attaching the Infusion Assembly 1 2 After setting up the diabetes manager (see Chapter 3), the Prepare micropump display appears. Tap OK. Read the instructions shown on the Prepare micropump display. If you want to see the steps as an animated video, tap Help. Once you have performed all 3 steps, tap Done. 62 wWARNING Before using the insertion device for the first time or if it has been stored for a longer period, before inserting the cannula, you must push down the safety release on the insertion device and press the release button on the insertion device to check that it does not contain a cannula. There is a risk that the cannula may not be inserted under the skin correctly due to insufficient spring tension in the insertion device. Note If there is an unexplained rise in your blood glucose level or an occlusion alarm occurs, check the micropump and the infusion assembly for occlusions and leaks. If you are unsure whether the infusion assembly is working properly, replace it immediately. man_07866364001_A_en.indb 62 28.07.2017 12:16:08 4.2.2 Step 1: Attaching the Infusion Assembly to the Body 1 2 3 4 Recommended Infusion Sites 4 Wash your hands with warm water and soap and dry them thoroughly. Select a suitable site on the body. Remove the micropump holder from the packaging. Disinfect the site on the body by wiping it with an alcohol wipe, for example. Then let the skin dry completely. Attach the hook of the micropump holder to the bottom of the insertion device. Press on the micropump holder lightly until it engages with the lock at the front of the insertion device. man_07866364001_A_en.indb 63 63 28.07.2017 12:16:09 Putting the Micropump Into Operation 5 6 7 8 Insert the cannula assembly diagonally into the cannula assembly slot. Push the cannula assembly into the slot until you hear it click into place. Use the positioning aid to check whether the cannula assembly has the correct position. Prime the insertion device by rotating the priming handle clockwise in the direction of the arrow by approximately half a turn. When the insertion device is fully primed, you will hear a click. 64 man_07866364001_A_en.indb 64 28.07.2017 12:16:10 9 10 11 12 Recommended Infusion Sites 4 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. Press the insertion device firmly against the selected site on the body so that the adhesive pad is applied evenly to the skin. Make sure the surface of the skin is taut. Smooth over the adhesive pad around the infusion assembly so that the infusion assembly is in good contact with the skin. Press the blue release button to insert the cannula under the skin. man_07866364001_A_en.indb 65 65 28.07.2017 12:16:12 Putting the Micropump Into Operation 13 14 15 16 Press the detach button and detach the insertion device from the infusion assembly. Press the infusion assembly and the edges of the adhesive pad against the skin so that the adhesive pad is smooth on the skin. Check whether the grey cannula head is visible in the opening of the cannula support and is flush with the cannula support. Remove the used cannula casing from the insertion device. The infusion assembly is now safely attached to the site on the body. If the grey cannula head is not visible, the cannula was not inserted. Remove the micropump holder and repeat Steps 2 to 15. 66 man_07866364001_A_en.indb 66 28.07.2017 12:16:13 17 wWARNING During disposal, ensure that no third party could injure themselves and risk an infection. Recommended Infusion Sites 4 Dispose of the used cannula casing according to local regulations. man_07866364001_A_en.indb 67 67 28.07.2017 12:16:13 Putting the Micropump Into Operation 4.2.3 Step 2: Filling the Reservoir with Insulin In addition to the reservoir assembly, you need an insulin vial with U100 insulin and a form of disinfectant, such as a sterile alcohol wipe. j Use and store insulin in compliance with the manufacturer specifications and pay attention to the use by date. j Make sure that the insulin is at room temperature before using it in the micropump. Use the reservoir immediately after filling it. j Occlusions may occur if the temperature of the insulin or micropump system is too low. j You can also use a 3ml pen cartridge to fill the reservoir. To do so, place the top of the cartridge onto the filling aid and press the seal stopper of the cartridge down with a pen or similar device. j During filling, make sure you remove any air bubbles from the reservoir. wWARNING j Use only permitted U100 insulin types to fill the reservoir. j If you connect an empty reservoir to the micropump (for example, for training purposes), insulin delivery (basal rate and bolus delivery) is nevertheless displayed, although no insulin is delivered because of the empty reservoir. j Never fill the micropump while it is connected to an infusion assembly attached to your body. There is a risk of uncontrolled insulin delivery. 68 man_07866364001_A_en.indb 68 28.07.2017 12:16:13 Filling a new reservoir with insulin 1 2 3 4 Recommended Infusion Sites 4 Disinfect the top of the insulin vial with a sterile alcohol wipe. Allow the disinfected top of the vial to dry. Remove the new reservoir assembly from the packaging. Carefully pull out the batterys protective film downwards in the direction of the arrow to activate the battery. Hold the round part of the handle firmly and pull it downwards in the direction ofthe arrow. man_07866364001_A_en.indb 69 Fill the reservoir with the volume of air that you later want to fill with insulin. 69 28.07.2017 12:16:14 Putting the Micropump Into Operation 5 6 7 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. Press the handle all the way down in the direction of the arrow to fill the insulin vial with air. Turn the reservoir assembly together with the insulin vial upside down so that the vial isabove the reservoir. Note j The reservoir must always be filled with a minimum of 80U for the electronics to detect that the reservoir is filled. j The reservoir has a maximum holding capacity of 200U (2.0ml). j Take care not to touch the reservoir needle. You might injure yourself. 70 man_07866364001_A_en.indb 70 28.07.2017 12:16:16 8 9 10 11 Recommended Infusion Sites 4 Gently flick your finger against the reservoir to release any air bubbles from the reservoir. 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. Push the handle upwards slightly in the direction of the arrow to push air bubbles out of the reservoir. Then pull the handle downwards again to fill the reservoir with the desired amount of insulin. Compress the corrugated part of the handle such that the upper end of the handle opens. Remove the handle from the piston rod to the side. Dispose of the handle. man_07866364001_A_en.indb 71 71 28.07.2017 12:16:18 Putting the Micropump Into Operation 12 4.2.4 Step 3: Connecting the Reservoir to the Pump Base 1 2 3 Detach the filling aid from the reservoir by removing it sideways in the direction of the arrow. Dispose of the filling aid. 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 Hold the pump base with one hand and the reservoir with the other. Push the filled reservoir onto the pump base until both parts are tightly connected. 72 man_07866364001_A_en.indb 72 28.07.2017 12:16:19 4 Note j Make sure that there is no gap between the reservoir and the pump base. j Do not exert too much force when connecting the pump base to the reservoir. j Make sure that the ventilation opening of the micropump is always clear so that the battery is fully functional. Pay attention to whether a rising sequence of tones is issued after connecting the reservoir and pump base. The sequence of tones confirms that the system components are connected to each other correctly and that the battery has been activated. man_07866364001_A_en.indb 73 Recommended Infusion Sites 4 Setting the reservoir fill amount 1 2 Read the reservoir level using the reservoir scale. With 2.0ml (200U), the reservoir shown in the figure above is full. and to set the Use insulin units with which you filled the reservoir. The set fill amount will be saved as the default setting for when the reservoir is filled the next time. Tap Save. 73 28.07.2017 12:16:20 Putting the Micropump Into Operation 4.2.5 Step 4: Pairing the Diabetes Manager and Micropump To be able to operate the micropump using the diabetes manager, you must pair the devices. Once the diabetes manager and the pump have been paired, the pairing settings are stored in both devices so that you do not have to repeat this process. If radio connection between the diabetes manager and the micropump is stopped or interrupted, it will automatically be restored once the devices are within an appropriate range of each other. You can simply use the camera on the 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. 74 Note Once a pump base is paired with a diabetes manager, it cannot be paired with a different diabetes manager. So if you are using a different diabetes manager than before, for example, a replacement device, it cannot be paired with the micropump that has been in operation so far. In this case, you must use a new pump base. man_07866364001_A_en.indb 74 28.07.2017 12:16:20 1 2 3 4 Recommended Infusion Sites 4 Hold the diabetes manager close to the micropump to establish the radio connection. The diabetes manager establishes the radio connection to the micropump. Tap Scan pairing code. Tap Next. Wait a moment. Point the camera of the diabetes manager at the pairing code on the pump base. Hold the diabetes manager such that the pairing code appears in the middle of the screen. man_07866364001_A_en.indb 75 75 28.07.2017 12:16:21 Putting the Micropump Into Operation 5 6 If the pairing code has been successfully scanned and registered, a signal is issued shortly afterwards. The micropump and the diabetes manager are now paired with each other. If the pairing code cannot be successfully scanned, you can enter the pump key manually. Tap Enter pump key. 76 Note You will find the pump key(s) on the inside of the packaging lid (of the starter kit or micropump kit). The pump serial number of the micropump is on the pump symbol. shield label and the packaging label next to the Pump key example:

Pump base 1 and 2 GW00000254 GW00000255 00000254 00000255 man_07866364001_A_en.indb 76 28.07.2017 12:16:21 7 8 Recommended Infusion Sites 4 4.2.6 Step 5: Filling the Reservoir Needle wWARNING 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. If several micropumps are within communication range:

Tap the pump serial number of your micropump. Enter the pump key using the keyboard. If pairing was successful, a signal is issued. Tap Done. man_07866364001_A_en.indb 77 77 28.07.2017 12:16:21 Putting the Micropump Into Operation 1 2 3 4 The micropump is now ready to fill the reservoir needle and issues a signal. The reservoir needle is filled. Wait a moment. Pay attention to the opening of the reservoir needle during filling. If you can see a drop of insulin at the tip of the needle, tap OK. Tap Fill. 78 When you see a drop of insulin at the tip of the needle, the reservoir needle is filled. Continue with Step 1 of the next section. button is The deactivated. man_07866364001_A_en.indb 78 28.07.2017 12:16:22 Recommended Infusion Sites 4 Note If you do not see a drop of insulin at the needle tip after a maximum of two minutes, there is still too much air in the reservoir. If no insulin drop is visible even after refilling the reservoir, you must use a new reservoir. 5 6 If you cannot see a drop of insulin at the tip of the needle, tap Repeat. The Repeat button is only activated after approx. 2 minutes. Tap Yes and follow the instructions on the displays that follow. man_07866364001_A_en.indb 79 79 28.07.2017 12:16:22 Putting the Micropump Into Operation 4.2.7 Step 6: Attaching the Micropump To attach the micropump correctly to the infusion assembly, you must engage the notch on the micropump with the hook on the infusion assembly. 1 2 Notch on the micropump Hook on the infusion assembly First place the pump onto the infusion assembly using slight pressure. Exert some pressure on the pump shield so that the micropump engages with the hook at the front of the infusion assembly. When the micropump is correctly attached to the infusion assembly, you hear aclick sound. 80 man_07866364001_A_en.indb 80 28.07.2017 12:16:23 3 4 wWARNING Recommended Infusion Sites 4 j Check the site on the body with the adhesive pad of the infusion assembly at least once a day. j Inserting the sensor under the skin or wearing the adhesive pad can cause the site to become irritated or inflamed. Symptoms include, amongst other things, redness, swelling, pain, heat sensation or weeping. Remove the infusion assembly if signs of inflammation or contamination are visible. Place a new infusion assembly on a different suitable site on the body. Note j Check at regular intervals whether the adhesive pad with the infusion assembly is securely attached to the body. A loose infusion assembly may interrupt insulin delivery. j If there is an unexplained rise in your blood glucose level or an occlusion alarm occurs, check the micropump and the infusion assembly for occlusions and leaks. Replace your infusion assembly if you are not sure whether it is working properly. 81 28.07.2017 12:16:24 Check whether the micropump is securely attached to the infusion assembly. The micropump is now ready for insulin delivery. Tap Next. A small amount of insulin is delivered to fill the micropump system. man_07866364001_A_en.indb 81 1 2 Putting the Micropump Into Operation 4.2.8 Activating the Basal Rate Profile After having completed all preparatory 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 setting for basal rate profiles you agreed on with your healthcare professional. For more information on basal rate profiles, see the chapter Basal Rate Profiles and Temporary Basal Rates. To confirm this step, press the insulin button green, on the diabetes manager. lit up in The Status screen displays the activated basal rate profile. 82 man_07866364001_A_en.indb 82 28.07.2017 12:16:24 4.2.9 Stopping and Starting the Micropump With the Stop interrupt or start insulin delivery again. and Start items in the Main menu, you can Recommended Infusion Sites 4 Stopping insulin delivery 1 2 Discuss with your healthcare professional when and for how long insulin delivery may be interrupted. If necessary, use a syringe or insulin pen to deliver insulin according to the instructions of your healthcare team. Note If your insulin delivery is interrupted for any reason, check your blood glucose level and deliver the missing insulin using a syringe or pen, for example, when:

j You stop or remove the pump for a longer period of time. j There is a technical problem with the pump. j There is an occlusion in the cannula/infusion assembly. j The reservoir or infusion assembly is leaking. j The infusion assembly has come loose at the infusion site. Tap Stop

. Tap Yes. man_07866364001_A_en.indb 83 83 28.07.2017 12:16:24 Putting the Micropump Into Operation While the micropump is in Stop mode, it emits a signal every hour to remind you that no insulin is being delivered. Starting or stopping insulin delivery Note Stopping the micropump cancels all ongoing boluses and the Temporary Basal Rate. or On the Status screen, tap the symbol to restart the In the Main menu, tap Start

. micropump. 84 man_07866364001_A_en.indb 84 28.07.2017 12:16:25 5 Testing Your Blood Glucose 5.1 Checking the Unit of Measurement Diabetes manager mmol/L 1 Mannheim, Germany Blood glucose results can be specified in two different units of measurement (mg/dL and mmol/L). As a result, two versions of the same diabetes manager are available. Check whether the diabetes manager displays the unit of measurement familiar to you. The unit of measurement your diabetes manager displays is shown on the back of your diabetes manager 1. If you do not know which unit of measurement is correct for you, contact your healthcare team. 5 wWARNING The unit of measurement that your diabetes manager displays cannot be changed. Contact your Customer Support and Service Centre if the wrong unit of measurement is printed on the back. A wrong unit of measurement may lead to incorrect interpretation of blood glucose results and therefore to wrong therapy recommendations being made, thus resulting in serious adverse health effects. j You need the diabetes manager, a test strip, a finger pricker and a lancet drum. j Set up the diabetes manager before testing your blood glucose for the first time. j Read the test strip package insert. In the package insert, you will find further important information on storage and possible causes of incorrect test results. man_07866364001_A_en.indb 85 85 28.07.2017 12:16:25 Testing Your Blood Glucose 5.2 Performing a Blood Glucose Test After inserting a lancet drum into the finger pricker and setting the penetration depth, you can start the blood glucose test. Note j When the diabetes Prior to the test 1 wWARNING j A blood glucose test that was performed incorrectly can lead to incorrect test results and thus to wrong therapy recommendations being made, which can result in serious adverse health effects. Therefore, follow the notes on how to perform blood glucose tests correctly, carefully. j A contaminated puncture site may lead to incorrect test results. Wash your hands and the puncture site with warm water and soap and rinse them well. j Test your blood glucose regularly, at least 4 times a day. j The micropump system is only intended for blood glucose testing with fresh capillary blood from the fingertip. manager prompts you to apply a drop, you have approximately 2 minutes to apply blood to the test strip. If you do not apply any blood during this time, the diabetes manager turns itself off. j Visually impaired persons must always be supported by a sighted person when applying the blood drop. j The micropump system is not suitable for testing blood from alternative sites. Wash your hands with warm water and soap and rinse them well. Dry your hands thoroughly with a clean towel before obtaining blood. 86 man_07866364001_A_en.indb 86 28.07.2017 12:16:25

2 Inserting the test strip 3 Performing a Blood Glucose Test 5 44 Note When the diabetes manager prompts you to apply a drop, you have approximately 2minutes to apply blood to the test strip. If you do not apply any blood during this time, the diabetes manager turns itself off. 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. Insert the test strip into the test strip slot of the diabetes manager in the direction 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 is issued. The Apply drop display appears. The test strip is readyfor testing. Put the diabetes manager aside. man_07866364001_A_en.indb 87 87 28.07.2017 12:16:27 Obtaining blood 5 6 Testing Your Blood Glucose j Do not allow any liquid to enter the test strip slot of the diabetes manager. j Remove the test strip in case of a test strip error, and repeat the blood glucose test using a new test strip. j Only apply blood to the test strip when the test strip is in the test strip slot and Apply drop is displayed. 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 Other ways to start a blood glucose test: In the Main menu, tap menu. If you want to perform a test in a dark the Test environment, this procedure is beneficial because the light at the test strip slot is turned on. Use your finger pricker to prick the side of a fingertip. Encourage a blood drop to form by gently massaging the finger in the direction of the fingertip. 88 man_07866364001_A_en.indb 88 28.07.2017 12:16:27 Applying blood 7 8 Displaying the test result 9 Performing a Blood Glucose Test 5 Note For information on blood glucose results, see the section Causes of Implausible Test Results in this chapter. j The blood glucose result can be used for bolus advice for a period of 15 minutes. Touch the blood drop to the front yellow edge of the test strip. Do not put blood on top of the test strip. The blood glucose test starts when enough blood has been drawn up by the test strip. The test result is displayed and saved. If the tone for blood glucose tests is turned on, a signal is issued. Tap OK. man_07866364001_A_en.indb 89 89 28.07.2017 12:16:28 Testing Your Blood Glucose 10 After approximately 3 seconds the Test result in detail display appears. If you want to add information (Time of test, Carbohydrates, Health events, Note) to the test result, follow the instructions in the following section. If you want to complete the blood glucose test without adding any information or delivering a bolus, tap Done. If you want to deliver a bolus, tap Bolus. 90 11 Note j You can subsequently change the added information in the My data menu. j If bolus advice has been calculated based on information you added about health events and carbohydrates, you cannot change this information anymore. Remove the used test strip and dispose of it according to local regulations. man_07866364001_A_en.indb 90 28.07.2017 12:16:28 Adding Information 5 5.3 Adding Information You can save additional information for a test result to describe certain events in connection with this test result or particular characteristics of the test result. If you are using the bolus advice feature, see also the information in Chapter 7 Bolus Advice. 1 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. wWARNING Incorrect entries for carbohydrate amounts or health events may lead to incorrect bolus advice. Tap Time of test. man_07866364001_A_en.indb 91 91 28.07.2017 12:16:29 Testing Your Blood Glucose 2 Entering carbohydrates If you test your blood glucose in connection with a meal, it is advisable to save the carbohydrate amount you consumed. If you are using bolus advice, the entered carbohydrate amount is used to calculate the insulin amounts you need. 3 4 Tap the desired Time of test

(for example, After meal). Tap Save. Tap Carbohydrates. or Use of carbohydrates consumed. to set the amount Tap Save. 92 man_07866364001_A_en.indb 92 28.07.2017 12:16:29 Adding Information 5 5 6 Setting health events If you have set up bolus advice and select a health event, bolus advice will be adjusted by the percentage you specified. If you have selected more than one health event in the Health events display, you will have to enter an overall percentage for the selected health events in the next step. Discuss health event adjustments with your healthcare professional, who will help you to determine the suitable percentage for the adjustment. Tap Health events. Choose from 1 to a maximum of 4 health events. Tap the appropriate health events. Tap Save. man_07866364001_A_en.indb 93 93 28.07.2017 12:16:29 Testing Your Blood Glucose Entering a note 10 11 12 In the Test result in detail menu, tap Add Note. You can enter a note (up to 280 characters) to save with this entry. Tap Done if you do not want to deliver a bolus at this time. If you want to deliver a bolus, tap Bolus. For more information, see the chapters Delivering a Bolus and Setting Up and Using Bolus Advice. 94 man_07866364001_A_en.indb 94 28.07.2017 12:16:30 Injection mode (without micropump): Entering basal insulin Adding Information 5 13 14 15 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. If the diabetes manager is not connected to the micropump

(injection mode): Tap Basal insulin. and to set the Use desired amount of basal insulin. If you want to save all entries without delivering a bolus, tap Done. Tap Save. If you want to save all entries and deliver a bolus, tap Bolus. man_07866364001_A_en.indb 95 95 28.07.2017 12:16:30 Testing Your Blood Glucose 5.4 Evaluating Test Results Blood glucose results reflect the current status of the blood glucose level. Test results are influenced by different factors, including type of diet, medication taken, state of health, stress and physical activity. Certain substances can interfere with the blood glucose result. This can lead to falsely elevated or lowered test results. For more information, see the test strip package insert. Note j Do not change your therapy based on single blood glucose results. j If the test result is below or above the blood glucose range that you defined with your healthcare professional, consult your healthcare professional. j If the test result does not match how you feel, for example, if it is unexpectedly low, eat fast acting carbohydrates. Afterwards, perform a control test with the Accu-Chek Aviva control solutions. Then repeat the blood glucose test. If the new test result still does not match how you feel, consult your healthcare professional. j If your blood glucose level is very high without any apparent cause, check the micropump system for occlusions or leaks. Repeat the blood glucose test. If in doubt, replace the reservoir and the infusion assembly. j If test results repeatedly do not match how you feel, check the items in the following section Causes of Implausible Test Results. 96 man_07866364001_A_en.indb 96 28.07.2017 12:16:30 5.4.1 Colour Coding of Test Results Green Blue Evaluating Test Results 5 On the Test result in detail display, a coloured dot appears to the right of the test result. The colour of the dot depends on how high the test result is in relation to the defined blood glucose target range for the current time block. Overview of meaning of colours:

Colour of dot Blood glucose result is Blue, Hyper Blue Green Yellow Red, Hypo above the hyper warning limit. It is strongly recommended that you test for ketones and test your blood glucose frequently. above your target range, but below your hyper warning limit. within your target range. below your target range, but above your hypo warning limit. below your hypo warning limit. It is strongly recommended that you eat a sufficient amount of fast acting carbohydrates immediately. man_07866364001_A_en.indb 97 Green dot:

The blood glucose result is within the target range for the current time block. Blue dot:

The blood glucose result is above the target range for the current time block. The blood glucose result does not exceed the hyper warning limit. 97 28.07.2017 12:16:30 Testing Your Blood Glucose Blue with Hyper Yellow Red Yellow dot:

The blood glucose result is below the target range for the current time block. The blood glucose result does not fall below the hypo warning limit. Red dot with the supplement Hypo:

The blood glucose result falls below the hypo warning limit. j Eat fast acting carbohydrates, such as juice or dextrose, and, if required, also slow carbohydrates, such as a cereal bar or bread. j Test your blood glucose again within the next half hour. j If hypoglycaemia persists, test your blood glucose and consult your healthcare professional. Blue dot with the supplement Hyper:

The blood glucose result exceeds the hyper warning limit. The diabetes manager displays a warning. Check blood glucose, ketones and insulin delivery. 98 man_07866364001_A_en.indb 98 28.07.2017 12:16:30 5.4.2 LO Display LO display Evaluating Test Results 5 Treat a very low blood glucose level as instructed by your healthcare professional. The LO display can also appear for technical reasons. wWARNING The LO display may indicate a very low blood glucose value

(possibly severe hypoglycaemia). Being aware of the symptoms of low blood glucose can help you to better understand your test results and decide what to do. Symptoms of low blood glucose (hypoglycaemia) may include:

j Anxiety, shakiness j Sweating, headache j Increased hunger, dizziness j Pale skin colour, fatigue j Sudden change in mood or irritability j Difficulty concentrating, clumsiness j Palpitations and/or confusion man_07866364001_A_en.indb 99 The blood glucose result is below the measuring range of the diabetes manager (less than 1.1 mmol/L). If you are experiencing a symptom of low blood glucose, proceed as follows:

j Eat fast acting carbohydrates, such as juice or dextrose, and, if required, also slow carbohydrates, such as a cereal bar or bread. j Test your blood glucose again immediately and then again within the next half hour. j If hypoglycaemia persists, test your blood glucose and consult your healthcare professional. 99 28.07.2017 12:16:30 Testing Your Blood Glucose 5.4.3 HI Display HI display Repeat the blood glucose test. If the repeated test also results in a HI display, proceed as instructed by your healthcare professional. Being aware of the symptoms of high blood glucose can help you to better understand your test results and decide what to do. Symptoms of high blood glucose (hyperglycaemia) may include:

j Increased thirst j Frequent urination j Blurred vision j Drowsiness j Abdominal pain/cramps j Nausea j Dizziness wWARNING The HI display may indicate a very high blood glucose value (possibly severe hyperglycaemia). Proceed as instructed by your healthcare professional straight away and repeat the blood glucose test. 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, contact your healthcare professional. 100 man_07866364001_A_en.indb 100 28.07.2017 12:16:31 5.4.4 Causes of Implausible Test Results Troubleshooting checks Evaluating Test Results 5 If the diabetes manager repeatedly displays implausible test results or error messages, check the items listed below. Answer the questions in the following table. If you cannot answer the questions in the table with yes, correct the respective item and repeat the test. If you have observed all these items and are still experiencing implausible test results or error messages, contact your Customer Support and Service Centre. man_07866364001_A_en.indb 101 Did you perform the blood glucose test as instructed in the Users Manual?

Did you wash your hands with warm water and soap and dry them thoroughly?

Did you only apply blood after Apply drop appeared on the screen?

Did you apply the blood drop immediately after it formed?

Are the test strips still valid (see the label on the test strip container next to the e symbol)?

Did you perform the test within the correct temperature range?

Did you observe the storage conditions for the diabetes manager and the test strips?

Did you observe the sources of error mentioned in the test strip package insert?

Was the cap on the test strip container always closed tightly?

101 28.07.2017 12:16:31 If you are not sure whether the diabetes manager is working properly, perform a control test. For more information, see the section Control Testing in the chapter Care and Maintenance of this Users Manual. Testing Your Blood Glucose Troubleshooting checks Did you use the test strip immediately after removing it from the test strip container?

Are the diabetes manager and test strips working properly?

wWARNING Implausible test results and error messages may also be caused by the diabetes manager having fallen off of something. If this is the case, contact your Customer Supportand Service Centre. Note Check at regular intervals whether the micropump system has visible or tangible signs of damage. This applies especially if the system components fell off of something orwere exposed to particular mechanical stress. 102 man_07866364001_A_en.indb 102 28.07.2017 12:16:31 6 Delivering a Bolus A bolus represents the required insulin amount to be delivered in addition to the basal rate, in order to cover the intake of food and correct an elevated blood glucose level. The bolus type and bolus amount are determined by your healthcare teams guidelines, your blood glucose level, your eating behaviour, your state of health as well as the type and duration of physical activity. A prerequisite for insulin therapy is that you received qualified training and are able to understand and apply the basic principles of bolus calculation according to the specifications of your healthcare team. 6 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. The entries required to program a manual bolus without using the bolus advice feature are made on the Bolus input display. When you enter the total amount for a manual bolus, this insulin amount is always added to the correction part of a bolus. A correction part is always delivered as a standard bolus or as an immediate delivery part of a multiwave bolus. man_07866364001_A_en.indb 103 103 28.07.2017 12:16:31 Delivering a Bolus 6.2 Bolus Input Display Blood glucose result The current test result is displayed. If no current test result exists, --- is displayed. Active insulin If bolus advice is activated, the amount of active insulin that is to be considered is displayed. If there is no active insulin, --- is displayed. This display element is only visible if the bolus advice feature is activated. Carbohydrate amount The carbohydrate amount entered after performing a blood glucose test is displayed. If no carbohydrate amount was entered, --- 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. 104 Correction bolus Tap this entry field to enter the insulin amount needed to bring a blood glucose value outside the target range back into the target range. Meal bolus Tap this entry field to enter the insulin amount to compensate for the food intake. Bolus type Tap this element to select one of the following bolus types: standard bolus, extended bolus, multiwave bolus, quick bolus, pen/syringe. man_07866364001_A_en.indb 104 28.07.2017 12:16:31 Bolus Types 6 6.3 Bolus Types You can choose from the following bolus types on the Bolus input display:

j Standard bolus j Extended bolus j Multiwave bolus In addition, you can choose a quick bolus, a customised bolus and a bolus with pen or syringe. Note the following for bolus input:

j When the Bolus input display appears for the first time, there is no bolus amount specified. You must enter the bolus amount. j If you first set the correction bolus or the meal bolus, the total bolus amount is deactivated and cannot be adjusted. The value, however, is updated accordingly. j Take the following into account when you enter the total amount:

The entry fields for correction bolus and meal bolus are deactivated. If you increase the total amount, the value for the correction bolus is increased accordingly. If you reduce the total amount, the value for the meal bolus is reduced, if one exists. Once the meal bolus reaches 0, the correction bolus is reduced accordingly. man_07866364001_A_en.indb 105 105 28.07.2017 12:16:31 Delivering a Bolus Symbol Name Description Standard bolus Extended bolus Multiwave bolus The standard bolus delivers the programmed insulin dose all at once. Use this bolus for foods that contain fast acting carbohydrates, such as cake or bread. Use the standard bolus if you want to correct an elevated blood glucose level. The extended bolus does not deliver the bolus insulin all at once, but over a longer period of time. Use the extended bolus for meals that are digested slowly, for example, foods with complex carbohydrates or foods that are high in fat and protein. An extended bolus can also be helpful for meals that extend over a longer period of time (for example, a buffet). 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 specified 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 with several courses. If you are planning to eat slowly digestible carbohydrates but have an elevated blood glucose level before the meal, you can use this bolus type as well. In this case, you program the immediate part of the bolus to correct the blood glucose level and the extended part for the carbohydrates. 106 man_07866364001_A_en.indb 106 28.07.2017 12:16:31 6.4 Programming a Bolus 1 You can program a bolus in different ways. Start with one of the following three options:

Programming a Bolus 6 or or Test result > Bolus Status screen > Bolus Main menu > Bolus Option 1:

Option 2:

Option 3:

After testing your blood glucose: On the Test result in detail display, tap Bolus. On the Status screen, tap New bolus or the symbol. In the Main menu, tap the Bolus menu. man_07866364001_A_en.indb 107 107 28.07.2017 12:16:32 Delivering a Bolus 2 3 4 5 Tap Manual bolus. Tap the entry fields that are appropriate to your situation to enter the correction bolus, meal bolus or total amount. 108 and to set the Use desired amount for the meal bolus. and to set the Use desired amount for the correction bolus. Tap Save. Tap Save. man_07866364001_A_en.indb 108 28.07.2017 12:16:32 6.4.1 Standard Bolus 1 2 The Standard bolus type is set as the default in the factory settings. Tap Bolus. To confirm this step and deliver the standard bolus, press the insulin button lit up in green diabetes manager screen. below the man_07866364001_A_en.indb 109 Programming a Bolus 6 3 When the diabetes manager is ready to deliver basal or bolus insulin, the insulin button below the screen lights up green. The Deliver insulin display with the green frame always appears when you deliver a bolus using the diabetes manager. Check the displayed total amount before pressing the insulin button. The micropump delivers the standard bolus. The Status screen is displayed with the current bolus information. 109 28.07.2017 12:16:33 1 2 3 Tap Type. Tap Extended bolus. Tap Duration. Then tap Save. Delivering a Bolus 6.4.2 Extended Bolus The duration of bolus delivery can be programmed in 15-minute increments for a period of up to 24 hours. Delivery begins immediately after you confirm the bolus. Throughout 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. 110 man_07866364001_A_en.indb 110 28.07.2017 12:16:33 Programming a Bolus 6 5 6 4 Note The duration you set for the extended bolus will be used as the default setting when the extended bolus is delivered the next time. and Use to set the hours and minutes for the extended bolus duration. Tap Save. Tap Bolus. To confirm this step and deliver the standard bolus, press the insulin button lit up in green diabetes manager screen. below the man_07866364001_A_en.indb 111 111 28.07.2017 12:16:34 7 Note You can add a standard bolus to an ongoing extended bolus and one additional extended bolus or a multiwave bolus. The micropump delivers the extended bolus. The Status screen is displayed with the current bolus information. Delivering a Bolus When the diabetes manager is ready to deliver basal or bolus insulin, the insulin button below the screen lights up green. The Deliver insulin display with the green frame always appears when you deliver a bolus using the diabetes manager. Check the displayed Total amount and the duration before pressing the insulin button. 112 man_07866364001_A_en.indb 112 28.07.2017 12:16:34 6.4.3 Multiwave Bolus The duration of the extended bolus delivery can be programmed in 15-minute increments for a period of up to 24 hours. Delivery begins immediately after you confirm the bolus. 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. 1 2 Tap Type. Tap Multiwave bolus. Then tap Save. Programming a Bolus 6 Note Start with the entries for the correction insulin and the meal bolus. If you enter the total amount first, you cannot make any entries for the correction bolus and the meal bolus. The entry fields will be deactivated (greyed out). man_07866364001_A_en.indb 113 113 28.07.2017 12:16:35 Delivering a Bolus 3 4 5 6 Tap Immediate amount to enter the bolus part that is to be delivered immediately. 114 and Use Immediate amount. to set the Tap Delayed amount to enter the bolus part that is to be delivered in a delayed fashion. and Use Delayed amount. to set the The Immediate amount must not be less than the part set for the correction insulin. Tap Save. The Delayed amount must not be greater than the part set for the meal bolus. Tap Save. man_07866364001_A_en.indb 114 28.07.2017 12:16:35 7 8 and Use duration of the delayed part. to set the Tap Save. Tap Duration. man_07866364001_A_en.indb 115 Programming a Bolus 6 9 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. Tap Bolus. 115 28.07.2017 12:16:36 When the diabetes manager is ready to deliver basal or bolus insulin, the insulin button below the screen lights up green. The Deliver insulin display with the green frame always appears when you deliver a bolus using the diabetes manager. Check the displayed Total amount, Immediate amount, Delayed amount and the duration before pressing the insulin button. 11 The micropump delivers the multiwave bolus. The Status screen is displayed with the current bolus information. Delivering a Bolus 10 To confirm this step and deliver the multiwave bolus, press the insulin button lit up in green diabetes manager screen. below the 116 man_07866364001_A_en.indb 116 28.07.2017 12:16:36 Quick Bolus 6 6.5 Quick Bolus A quick bolus is a bolus that can be programmed and delivered using the quick bolus buttons on the micropump. wWARNING As with the standard bolus, the quick bolus delivers the programmed insulin dose all at once. The quick bolus is suitable for meals that contain mainly carbohydrates that can be digested rapidly as well as for the correction of an elevated blood glucose level. A quick bolus allows a bolus to be discreetly delivered if the diabetes manager is not available or cannot communicate with the micropump. This is the case, for example, when flight mode is turned on. The bolus amount can only be programmed in defined increments. The basic setting for the quick bolus increment is 0.2 units. Thus, you can set the bolus amount to 0.2 units, 0.4 units, 0.6 units and so on. If necessary, you can change the quick bolus increment to 0.2, 0.5, 1.0 or 2.0 units. See the chapter Changing Settings. j Make sure that you know and use the set quick bolus increment. If you use a different quick bolus increment to the one you intended, an incorrect insulin dose will be delivered. j Note that a quick bolus is always considered to be a correction bolus. Note Fill in the increment you set for the quick bolus on the flap card of the perforated cover page. man_07866364001_A_en.indb 117 117 28.07.2017 12:16:36 Delivering a Bolus 6.5.1 Programming a Quick Bolus 1 2 3 4 Tap Type. Tap Quick bolus. Tap Bolus. Then tap Save. Check the total amount and follow the instructions given inthe information. Tap OK. 118 man_07866364001_A_en.indb 118 28.07.2017 12:16:37 Note If you made entries for the quick bolus on the Bolus input display, they must be confirmed by the micropump within a period of 15 minutes. Otherwise, these entries may not be assigned correctly. As a result, the entries that cannot be synchronised by the micropump system will be discarded. 6.5.2 Delivering a Quick Bolus 1 2 Quick Bolus 6 Example With a quick bolus increment of 0.5 units, you must press the quick bolus buttons 5 times to deliver an insulin amount of 2.5 U. 3 s Press and hold both quick bolus buttons for approximately 3 seconds until you hear a sequence of signals. Simultaneously press both quick bolus buttons repeatedly until the desired insulin amount is set. The micropump issues a signal every time the buttons are successfully pressed. man_07866364001_A_en.indb 119 119 28.07.2017 12:16:37 Delivering a Bolus Note j If you have not pressed the quick bolus buttons for approximately 3 seconds, the entry phase ends and the micropump provides acoustic feedback. A signal is issued for each programmed quick bolus increment. j If you do not confirm the acoustic feedback in Step4 by pressing the quick bolus buttons, no bolus will be delivered and a sequence of signals for cancelling the bolus will be issued. 120 3 4 Check whether the acoustic feedback corresponds to the desired insulin amount. If the acoustic feedback corresponds to the bolus amount you require, press the quick bolus buttons to confirm insulin delivery until you hear a sequence of signals. Note Enter the insulin and carbohydrate amounts associated with the quick bolus in the logbook. Be sure to assign correction and mealtime boluses correctly. Otherwise, subsequent data entries in the logbook as well as future bolus advice calculations might not be correct. man_07866364001_A_en.indb 120 28.07.2017 12:16:38 6.6 Delivering the Bolus with a Pen or Syringe Delivering the Bolus with a Pen or Syringe 6 1 2 If you want to deliver a bolus with a pen or syringe, you can document the insulin amounts delivered on the Bolus input display. The boluses that you deliver with a pen or syringe are saved in the diabetes manager database. The entered insulin amounts are evaluated for future bolus advice calculations. This improves the result of further bolus advice calculations. Tap the Pen/syringe bolus type. Select one of the 3 options for bolus delivery that are mentioned in the section Standard Bolus. Perform the appropriate steps until the Bolus input menu is displayed. Tap Type. 121 28.07.2017 12:16:38 man_07866364001_A_en.indb 121 Delivering a Bolus 3 4 5 6 and to set the Use insulin amount you want to deliver using a pen or syringe. Tap Save. Tap Bolus. If the total amount to be delivered is correct, tap OK. Tap the desired entry field. If you tap Total amount, the entered insulin amount is added to the correction bolus. 122 man_07866364001_A_en.indb 122 28.07.2017 12:16:39 7 Inject the insulin units with a pen or syringe. man_07866364001_A_en.indb 123 Cancelling a Bolus 6 6.7 Cancelling a Bolus Example To cancel an ongoing bolus, press the screen or in the Main menu. If this is not possible, remove the micropump from the infusion assembly. button on the Status 6.7.1 Cancelling Bolus Programming Standard, extended and multiwave bolus While programming, press the previous step and enter a new value. button to go back to the Quick bolus If you do not confirm the quick bolus by pressing both quick bolus buttons within 5 seconds of the acoustic feedback for the insulin amount, programming of the quick bolus will be cancelled automatically. 123 28.07.2017 12:16:40 Delivering a Bolus 6.7.2 Cancelling a Bolus During Delivery If you have the diabetes manager at hand: Press the during bolus delivery to cancel the bolus. Bolus delivery is cancelled and the diabetes manager displays warning W38 Bolus cancelled. button If you do not have the diabetes manager at hand: Remove the micropump from the infusion assembly for as long as the bolus is being delivered. Then place the micropump back onto the infusion assembly. 6.7.3 Cancelling a Bolus Using the Cancel bolus Menu In the Main menu and on the Status screen, you can cancel a bolus by tapping In the Bolus menu, you can tap the Cancel bolus item. Here you can cancel one bolus or all ongoing boluses. 124 1 Cancelling all boluses 2 On the Status screen or in the Main menu, tap

. If you want to cancel all ongoing boluses at the same time, tap Cancel all boluses. man_07866364001_A_en.indb 124 28.07.2017 12:16:40 Cancelling a Bolus 6 Cancelling single boluses 4 5 3 Note The display in Step 2 only appears if more than one bolus is programmed. If you want to cancel all boluses now, tap Yes. Tap the bolus you want to cancel. Tap Yes if you want to cancel the bolus now. man_07866364001_A_en.indb 125 125 28.07.2017 12:16:41 Delivering a Bolus 6.8 Delaying Bolus Delivery In some situations (for example, if you have gastroparesis) it may be helpful to only start a bolus after you have started eating. You can use the delivery lag time setting 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 team. If you want to use the delivery lag time, you must activate this feature in the Bolus settings menu first (see chapter Settings). Note If a bolus contains correction insulin, it is not possible to enter a delivery lag time. Correction insulin must always be delivered immediately. 126 Setting the delivery lag time 1 2 Tap the required bolus type, for example, Standard bolus. Select one of the 3 options for bolus delivery that are mentioned in the section Standard Bolus. Perform the appropriate steps until the Bolus input menu is displayed. Tap Type. man_07866364001_A_en.indb 126 28.07.2017 12:16:41 3 4 5 6 Delaying Bolus Delivery 6 Tap Bolus. Tap Delivery lag time. man_07866364001_A_en.indb 127 and Use Delivery lag time. to set the Tap Save. Tap Bolus. 127 28.07.2017 12:16:42 Delivering a Bolus 7 8 To confirm this step and deliver the standard bolus, press the insulin button lit up in green diabetes manager screen. below the The Status screen is displayed with the current bolus information and the set delivery lag time. 128 man_07866364001_A_en.indb 128 28.07.2017 12:16:42 7 Bolus Advice The bolus advice feature aims to bring your blood glucose level back into the target range defined for you, by delivering an insulin amount that was calculated in advance. The bolus advice feature of the diabetes manager consists of two components: First, a recommendation for a correction bolus to adjust your blood glucose level if it is not within the target range. Secondly, a recommendation for a meal bolus that covers your food intake. However, the bolus advice feature only makes a recommendation if you set up (configured) bolus advice beforehand. 7.1 Overview The bolus advice feature of the diabetes manager consists of two components: First, a recommendation for a correction bolus to adjust your blood glucose level if it is not within the target range. Secondly, a recommendation for a meal bolus that covers the carbohydrates contained in your meals. The recommendation for the correction bolus is positive if your current blood glucose level is above your target range. If, at the same time, a meal bolus is recommended, a negative correction bolus lowers the total insulin amount of bolus advice. man_07866364001_A_en.indb 129 7 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 Bolus advice is calculated based on the current blood glucose value, your carbohydrate intake and other factors. j Insulin from a previous bolus that is still acting and difficult to be estimated manually, is taken into account automatically. j Therapy schemes can be adhered to more consistently. j Blood glucose values can be kept within the target range for a longer time period more easily. 129 28.07.2017 12:16:42 Bolus Advice Note the following:

j The micropump system is not able to judge your current situation independently of your own assessment. j Insulin that was not delivered via the micropump system can only be taken into account if you specify this in the diabetes manager. j Bolus advice cannot correct any input errors. This is particularly true for the carbohydrate amount entered. j Warnings are displayed for entries that exceed possible limit values. j No warning message is displayed if the data is possible (within the acceptable ranges) but incorrect. Therefore, it is important to carefully review all of your entries. 130 Terminology for setting bolus advice Carbohydrate ratio The carbohydrate ratio defines the insulin amount necessary to compensate for a certain amount of ingested carbohydrates. Insulin sensitivity The insulin sensitivity defines the insulin amount required to lower your blood glucose level by a certain value. Target range The target range describes which blood glucose values are considered acceptable when fasting or before a meal. The target range is specified by the lower and upper BG thresholds. Meal rise During or after meals, an increase in the blood glucose level is considered normal within a certain range, even if a bolus was delivered. Enter the maximum increase in your blood glucose level that is to be tolerated without an additional correction bolus. Snack size The snack size defines a carbohydrate threshold; when this is exceeded, a meal rise should be taken into account. Thus, the snack size indicates which carbohydrate amounts should not be considered as regular meals with an expected and tolerated meal rise. man_07866364001_A_en.indb 130 28.07.2017 12:16:42 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. You can specify the duration of the acting time according to your needs. The total acting time includes the offset time. Note j Discuss intended changes to your bolus advice options with your healthcare professional in advance. j After bolus advice is set up, you can change the options or turn off bolus advice, if required. j If you turn off bolus advice, all bolus advice options will be deleted. Overview 7 Offset time The offset time is the period of time after which the insulin is expected to start lowering the blood glucose level in the body. Time blocks Time blocks allow you to divide the day into different time periods according to your individual lifestyle. Time blocks help you and your healthcare professional to recognise more easily how your blood glucose level is affected by your daily activities and lifestyle. man_07866364001_A_en.indb 131 131 28.07.2017 12:16:42 Bolus Advice 7.2 Setting Up Bolus Advice Main menu > Settings > Bolus settings After you turn on bolus advice, you set up the time blocks first. All time blocks add up to a time period of 24hours. The diabetes manager factory settings contain 5default time blocks. You can set up a maximum of 8time 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. wWARNING Discuss intended changes to your bolus advice options with your healthcare professional in advance. 1 2 Tap Bolus advice. Tap Yes. 132 man_07866364001_A_en.indb 132 28.07.2017 12:16:43 Defining a time block 1 2 3 4 Setting Up Bolus Advice 7 The display for defining the first time block appears. Tap Start time. and Use time for the first time block. to set the Start and Use to set the End time for the first time block. The changed start and end times for the first time block are displayed. The minutes can be set in 15-minute increments. The minutes can be set in 15-minute increments. Tap Done. If you want to keep the start and end times, tap Done. Tap Save. Tap Save. The button is deactivated. man_07866364001_A_en.indb 133 133 28.07.2017 12:16:44 Bolus Advice Setting the target range 1 2 3 4 Tap Upper limit value. If you do not want to modify the limit values for the target range, tap Next. Use and limit value. Tap Save. to set the Upper Use and limit value. Tap Save. to set the Lower The limit values currently set for the target range are displayed. Tap Next. 134 man_07866364001_A_en.indb 134 28.07.2017 12:16:45 Defining the default settings 1 Note The Done button on the Default settings display remains deactivated (grey) until the entries for Carbohydrate ratio and Insulin sensitivity are complete. To define the default settings, tap the adjustment fields for the Carbohydrate ratio. Then tap the adjustment fields for the Insulin sensitivity. Example Carbohydrate ratio:

1.00 U : 10g In this example, one insulin unit compensates for 10g ofcarbohydrates. Setting Up Bolus Advice 7 Carbohydrate ratio 2 3 to set the and Use insulin units for the Carbohydrate ratio. and to set the Use carbohydrate amount for the Carbohydrate ratio. Tap Save. Tap Save. man_07866364001_A_en.indb 135 135 28.07.2017 12:16:46 Insulin sensitivity 4 5 6 Bolus Advice Example Insulin sensitivity:

1.00 U : 2.2 mmol/L In this example, one insulin unit lowers the blood glucose value by 2.2mmol/L. and to set the Use insulin units for the Insulin sensitivity. and to set the blood Use glucose value for the Insulin sensitivity. Tap Done. Tap Save. Tap Save. 136 man_07866364001_A_en.indb 136 28.07.2017 12:16:47 7 Changing the time block settings 1 2 Setting Up Bolus Advice 7 Note You can change 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. The default settings for carbohydrate ratio and insulin sensitivity are copied to all time blocks. You can change the settings for each time block separately. Tap OK. Tap the time block you want to change. Tap End time. If you do not want to change the copied settings for the other time blocks, tap Done. Continue with the section Setting health events. man_07866364001_A_en.indb 137 137 28.07.2017 12:16:48 Bolus Advice 3 4 5 6 Set the End time for the selected time block. Tap Next. Set the upper and lower limit values. Tap Done when you have completed the desired settings for all time blocks. Tap Save. Tap Next. 138 man_07866364001_A_en.indb 138 28.07.2017 12:16:50 Setting health events Health events or your activities have an impact on your blood glucose level. Bolus advice calculation takes health events into account. Each health event adjusts bolus advice by the percentage set by you. A positive percentage (+) increases the bolus amount and a negative percentage (-) decreases the bolus amount. You can choose between 5default health events and 3customised health events:

j Exercise1 j Exercise2 j Stress j Illness j Premenstrual 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%. The percentage can be changed in increments of 5%. Discuss changes to your bolus advice options with your healthcare professional in advance. man_07866364001_A_en.indb 139 Setting Up Bolus Advice 7 wWARNING Incorrectly entered health events may lead to inappropriate bolus advice. Example You go for a run and create the customised health event Run with a percentage of -20%. When you select the Run health event during bolus calculation, the bolus amount is decreased by 20%. 139 28.07.2017 12:16:50 Bolus Advice Setting a health event 1 2 Customised health event 3 4 Tap the health event for which you want to make settings (for example, Stress). Enter a Percentage for the selected health event. The Health events are displayed with the percentages that were set. to enter a name (for Tap example, Run) for the customised health event. Tap Save. Repeat Steps 1 and 2 to set the percentage for other health events. If you want to set a customised health event, tap

. 140 man_07866364001_A_en.indb 140 28.07.2017 12:16:51 5 6 and to set the Use percentage for the customised health event. The Health events are displayed with the percentages that were set. Tap Save. Tap Done. man_07866364001_A_en.indb 141 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 professional, who will help you to determine the suitable percentage for the adjustment. Setting Up Bolus Advice 7 7 Specify a total percentage for the health events. Tap Save. 141 28.07.2017 12:16:52 Bolus Advice Changing percentages for health events 1 2 3 4 Tap Health events. Tap the health event for which you want to make settings (for example, Stress). Enter a percentage for the selected health event. The Health events are displayed with the percentages that were set. Tap Save. Repeat Steps 2 and 3 to set the percentage for other health events. Tap Done after setting the health events. 142 man_07866364001_A_en.indb 142 28.07.2017 12:16:53 Setting Up Bolus Advice 7 Meal rise 2 Snack size 3 Bolus advice options 1 Note The Done button on the Bolus advice options display remains deactivated (grey) until the entries for Meal rise, Snack size, Acting time and Offset time are complete. Tap Meal rise, Snack size, Acting time and Offset time to adjust the respective settings. to set the meal and Use rise value. Tap Save. Use and size value. Tap Save. to set the snack man_07866364001_A_en.indb 143 143 28.07.2017 12:16:53 Bolus Advice Acting time 4 Offset time 5 6 7 to set the hours and Use and minutes for the acting time. to set the hours and Use and minutes for the offset time. Tap Save. Tap Save. 144 Tap Done to complete the setup wizard. All settings for calculating bolus advice are now complete. Tap OK. man_07866364001_A_en.indb 144 28.07.2017 12:16:54 7.2.1 Adding a Time Block Adding time blocks 1 2 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. Tap the last time block. Tap End time and change it to the desired end time (for example, from 05:30 to 03.30). Tap Next. Setting Up Bolus Advice 7 Note j Decrease the End time of the last time block by any amount in order to create a new time block. This creates a new time block by splitting the last time block into 2 time blocks. j However, do not decrease the End time until it equals the Start time because this will delete the time block. man_07866364001_A_en.indb 145 145 28.07.2017 12:16:55 Bolus Advice 3 4 5 6 The last time block is split into two time blocks (for example, second to last time block 22:0003:30, last time block 03:3005:30). Tap Done. Set the Upper limit value and Lower limit value for the new time block. Set the Carbohydrate ratio and Insulin sensitivity for the new time block. It may be necessary to change the end times and settings of other time blocks. Tap Next. Tap Done. Tap Done when you have finished editing the time blocks. 146 man_07866364001_A_en.indb 146 28.07.2017 12:16:56 7.2.2 Deleting Time Blocks Deleting several time blocks 1 2 3 Setting Up Bolus Advice 7 This section describes how to delete one or more time blocks. The first method to delete one or more time blocks is to merge time blocks. Select the first time block that is to be merged with one or more time blocks. Increase the end time until it equals the end time of the last time block to be deleted. Tap Yes if you want to delete the time blocks. In this example, the three time blocks between 08:30 and 22:00 are being merged. Tap Next. man_07866364001_A_en.indb 147 147 28.07.2017 12:16:57 Bolus Advice 4 5 6 Set the Upper limit value and Lower limit value for the merged time block. Set the Carbohydrate ratio and Insulin sensitivity for the merged time block. It may be necessary to change the end times and settings of the remaining time blocks. Tap Done. Tap Done. Tap Done when you have finished editing the time blocks. 148 man_07866364001_A_en.indb 148 28.07.2017 12:16:58 1 2 3 Setting Up Bolus Advice 7 Deleting a single time block The second method deletes a single time block by decreasing the end time of the time block until it is the same as its start time. After time blocks have been deleted, it may be necessary 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. Tap the time block to be deleted. Decrease the end time until it equals the start time. Tap Yes if you want to delete the time block. In this example, the time block from 11:30 to 15:30 is to be deleted. Tap Next. man_07866364001_A_en.indb 149 149 28.07.2017 12:16:58 Bolus Advice 4 5 6 Set the Upper limit value and Lower limit value for the new time block. Set the Carbohydrate ratio and Insulin sensitivity for the merged time block. It may be necessary to change the end times and settings of the remaining time blocks. Tap Done. Tap Done. Once you have finished editing the time blocks, tap Done. 150 man_07866364001_A_en.indb 150 28.07.2017 12:16:59 Setting Up Bolus Advice 7 2 3 7.2.3 Resetting All Time Blocks 1 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 may be one reason for resetting all time blocks. Tap Reset. If you want to reset all time blocks, tap Yes. Set the Start time and End time for the first time block. Tap Done. man_07866364001_A_en.indb 151 151 28.07.2017 12:17:00 Bolus Advice 4 5 6 7 Set the default values for the Upper limit value and Lower limit value. Set the default values for the Carbohydrate ratio and Insulin sensitivity. Tap OK. Tap Done. 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. 152 man_07866364001_A_en.indb 152 28.07.2017 12:17:01 7.2.4 Changing Bolus Advice Options 1 2 This section describes how to change the values for meal rise, snack size, acting time and offset time. Setting Up Bolus Advice 7 Tap Bolus advice options. Tap the respective entries to set the Meal rise, Snack size, Acting time and Offset time. Tap Done after making all the settings. man_07866364001_A_en.indb 153 153 28.07.2017 12:17:02 Bolus Advice 7.3 Using Bolus Advice Delivering a recommended bolus You can use the bolus advice feature directly after testing your blood glucose. Note that a blood glucose result is only valid for bolus advice within 15 minutes of the blood glucose test. You can also call up bolus advice from the Status screen or Main menu. Additional information:

j The symbol indicates that the bolus advice feature is turned on. If no bolus advice is set up, bolus advice is turned off or a symbol is displayed. manual bolus was delivered, the j If you deliver a bolus straight from the micropump, the information on the total bolus amount is taken into account for future bolus advice. However, the total bolus amount is considered as a correction bolus, and no meal rise is registered. If this bolus was used for food intake, you should edit the bolus in your logbook to assign the bolus part that was used for the carbohydrates. This ensures that you receive as accurate bolus advice as possible as a direct consequence

(during acting time). j If you provide values for Blood glucose result, Carbohydrates and Health events to calculate bolus advice, you will obtain the best results. All entries are saved. 154 man_07866364001_A_en.indb 154 28.07.2017 12:17:02 Starting bolus advice after a BG test 1 2 3 If you have entered only one or no health event, the Health events display will not appear. Using Bolus Advice 7 Tap the respective entries to add information on Time of test, Carbohydrates or Health events. Tap Bolus. Enter the percentage for the total amount if you have selected several health events. Tap Save. Tap Bolus. man_07866364001_A_en.indb 155 155 28.07.2017 12:17:02 Bolus Advice The bolus advice feature calculates a suggestion and transfers the recommended values to the entry fields. Tap the respective entry fields if you want to change the suggested values. Selecting the bolus type 4 Changing bolus advice values Correction bolus Meal bolus, changed Value has been updated If you change the correction bolus or meal bolus first, the Total amount cannot be changed. The value, however, is updated accordingly (see figure). Tap Type to select the desired bolus type. If you change the Total amount first, the correction bolus and meal bolus cannot be changed. Tap Bolus. If you increase the Total 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 reduced accordingly. 156 man_07866364001_A_en.indb 156 28.07.2017 12:17:03 Using Bolus Advice 7 Confirming the bolus 6 7 5 Note Not every bolus type can be selected, depending on the setting. You cannot select an extended bolus, for example, if a correction bolus is to be delivered. Tap Bolus. To confirm this step and deliver the standard bolus, press the insulin button lit up in green diabetes manager screen. below the The Status screen is displayed showing the current bolus information. man_07866364001_A_en.indb 157 157 28.07.2017 12:17:03 Bolus Advice Starting bolus advice without a BG test 1 2 3 or On the Status screen, tap New bolus or the symbol. In the Main menu, tap the Bolus menu. Tap Bolus advice. Tap No to obtain bolus advice without performing a blood glucose test. 158 man_07866364001_A_en.indb 158 28.07.2017 12:17:04 4 Entering carbohydrates 5 Confirming the bolus 6 Using Bolus Advice 7 Note If no valid blood glucose result exists and you do not want to test your blood glucose, you can enter the carbohydrate amount you consumed. If you then tap Bolus on the Bolus advice display, a suggestion for a meal bolus is displayed. Enter a carbohydrate amount of up to 240g. Enter the carbohydrates consumed. Tap Bolus. To set the carbohydrates using the keyboard, tap

. Tap Save. To confirm this step and deliver the bolus, press the insulin button lit up in green below the diabetes manager screen. man_07866364001_A_en.indb 159 159 28.07.2017 12:17:05 Bolus Advice 7.3.1 Bolus Advice for Pen/Syringe The bolus advice feature is also available in injection mode. Make sure 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 Tap Pen/syringe. Start bolus advice with or without testing your blood glucose. Tap Type. 160 man_07866364001_A_en.indb 160 28.07.2017 12:17:05 3 4 5 6 Using Bolus Advice 7 Once you have completed your entries, tap Bolus. Tap OK. The Status screen is displayed. Deliver the insulin units you confirmed with a pen or syringe. man_07866364001_A_en.indb 161 161 28.07.2017 12:17:06 Bolus Advice 7.4 Turning Off Bolus Advice Main menu > Settings > Bolus settings This section describes how to turn off bolus advice. Note If you turn off bolus advice, all bolus advice options will be restored to the factory settings. If you want to use bolus advice again, you must set it up once again. 1 2 Tap Bolus advice. Tap Yes if you want to turn off bolus advice now. The bolus advice options will be deleted!

162 man_07866364001_A_en.indb 162 28.07.2017 12:17:06 8 Basal Rate Profiles and Temporary BasalRates 8 8.1 Basal Rate Profiles In this chapter you will learn how you can adapt your basal insulin supply to your life situations using different basal rate profiles and Temporary Basal Rates (TBR). The basal rate is a continuous delivery of insulin that covers the meal-independent insulin requirement. The size of the basal rate depends on your personal circumstances and the time of day. A basal rate profile consists of a combination of basal rates that are defined according to your personal requirements and cover 24 hours a day. If your insulin needs differ on certain weekdays, on weekends, during illness or on holiday, you can create and use different basal rate profiles. You can set up a maximum of 5 basal rate profiles in the diabetes manager. Basal rate profiles are defined through basal rate segments. Each basal rate segment needs a start time and an end time as well as an insulin amount, which is specified in insulin units per hour

(U/h). If you activate 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. Note If you activate a different basal rate profile, all ongoing insulin deliveries (basal rate, boluses) will be cancelled. man_07866364001_A_en.indb 163 163 28.07.2017 12:17:07 Basal Rate Profiles and Temporary BasalRates 8.2 Creating and Editing a Basal Rate Profile 1 A basal rate profile can be programmed, edited and deleted in different ways. Start by using one of the following two options:

or 2 On the Status screen, tap the area indicating the basal rate. In the Main menu, tap the Basal rate menu. In the Basal rate menu, tap Basal rate profiles. 164 man_07866364001_A_en.indb 164 28.07.2017 12:17:07 8.2.1 Programming a Basal Rate Profile Note j Basal rate time blocks are not identical to or shared with the time blocks for bolus advice. 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 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 To delete a time block, set the end time of the time block to equal the start time of the same time block. j When the maximum possible number of 5 basal rate profiles is reached, the Basal rate profiles display does not show the symbol. man_07866364001_A_en.indb 165 Creating and Editing a Basal Rate Profile 8 1 2 to add a basal rate Tap profile. Tap the item with the symbol. Enter the desired name (for example, Weekend) for the Basal rate profile. The name may have up to 12 characters. Confirm your entry with

. 165 28.07.2017 12:17:08 Basal Rate Profiles and Temporary BasalRates 3 4 5 6 Tap the first time block. Set the end time and the insulin amount. 166 and to set the Use end time for the time block (for example, start at 07:00, end at 08:30). and to set the Use insulin amount for the time block (for example, 1.50 U/h). Tap Save. Tap Save. Repeat this process for all 24 time blocks. Tap Save. If you want to use the basal rate profile immediately, tap Activate. man_07866364001_A_en.indb 166 28.07.2017 12:17:08 7 8.2.2 Activating a Basal Rate Profile 1 2 3 Creating and Editing a Basal Rate Profile 8 The newly programmed basal rate profile is displayed in the overview of the existing basal rate profiles. Check whether the total amount displayed corresponds to the total amount defined by your healthcare professional. Tap the basal rate profile you want to activate (for example, Profile 2). The currently active basal rate profile is indicated by the symbol. If required, scroll the screen upwards to be able to check all time blocks of the basal rate profile. Once all settings are correct, tap Activate. To confirm this step and activate the basal rate profile, press the insulin button lit up in green diabetes manager screen. below the man_07866364001_A_en.indb 167 167 28.07.2017 12:17:09 Basal Rate Profiles and Temporary BasalRates 4 Note cancels the Tapping activation of the selected basal rate profile and takes you to the previous display. The basal rate profile that was previously active, remains active. The activated basal rate profile is displayed on the Status screen. 168 man_07866364001_A_en.indb 168 28.07.2017 12:17:09

8.2.3 Deleting a Basal Rate Profile 1 2 3 4 Creating and Editing a Basal Rate Profile 8 Tap the basal rate profile you want to delete (for example, Profile 3). symbol in the upper Tap the right corner of the screen. If the active basal rate profile is to be deleted, the following display appears. The selected basal rate profile was deleted from the list of available basal rate profiles. Tap Yes to delete the basal rate profile. man_07866364001_A_en.indb 169 169 28.07.2017 12:17:10 Basal Rate Profiles and Temporary BasalRates 8.3 Temporary Basal Rates A Temporary Basal Rate (TBR) allows you to temporarily increase or decrease your active basal rate profile on a percentage basis for a specific duration. This helps you to better control your blood glucose level during illness, physical activity or in other situations. Temporary Basal Rates can be set in increments of 10% over a period of 15minutes to 24hours. TBR Decrease Increase Settings range 090%

110250%

Note j A TBR can only be programmed when the micropump is running. j Stopping the pump (Stop mode) stops TBR delivery as well as any bolus delivery. j When the duration of the TBR has expired, you are informed that the programmed basal rate has finished. 170 man_07866364001_A_en.indb 170 28.07.2017 12:17:10 8.4 Creating and Editing a TBR 1 A Temporary Basal Rate can be programmed, edited and deleted in different ways. Start by using one of the following two options:

or Creating and Editing a TBR 8 2 On the Status screen, tap the basal rate profile. In the Main menu, tap the Basal rate menu. Tap Temporary basal rate. man_07866364001_A_en.indb 171 171 28.07.2017 12:17:10 Basal Rate Profiles and Temporary BasalRates 8.4.1 Programming a TBR 1 2 3 4 Tap Standard TBR. Tap Percentage to enter the percentage of the Temporary Basal Rate. 172 and to set the Use percentage for adjusting the Temporary Basal Rate. Tap Duration to enter the running time for the Temporary Basal Rate. Tap Save. man_07866364001_A_en.indb 172 28.07.2017 12:17:11 5 6 and Use to set the hours and minutes for the duration of the standard TBR. Tap Activate. Tap Save. Note You can only activate the TBR if the percentage is less than or greater than 100% (for example, 90% or 110%). cancels the Tapping activation of the standard TBR and takes you to the previous display. The Standard TBR that was previously active, remains active. man_07866364001_A_en.indb 173 Temporary Basal Rates 8 7 To confirm this step and start the standard TBR, press the insulin button lit up in green below the diabetes manager screen. 173 28.07.2017 12:17:11 Basal Rate Profiles and Temporary BasalRates 8 8.4.2 Programming a Customised TBR You can program and save customised Temporary Basal Rates forrecurring situations that change your insulin needs. 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. 1 Example You want to run for 1 hour. You know that your body needs 25% less insulin during this activity and the subsequent recovery phase of 2hours. You program a TBR of 75% for the next 3hours. The diabetes manager shows the Status screen with the current TBR information. to add a customised Tap TBR. 174 man_07866364001_A_en.indb 174 28.07.2017 12:17:12 Temporary Basal Rates 8 2 3 4 Note A customised TBR less than 100% is indicated by this

. A TBR greater symbol than 100% is indicated by this symbol

. Tap Percentage to enter the Percentage for the Customised TBR. Tap the symbol. Enter the desired name for the Customised TBR (for example, Run). The name may have up to 12 characters. Confirm your entry with

. man_07866364001_A_en.indb 175 and to set the Use Percentage for adjusting the Customised TBR. Tap Save. 175 28.07.2017 12:17:12 Basal Rate Profiles and Temporary BasalRates 6 7 8 9 Tap Duration to enter the running time for the Customised TBR. and Use to set the hours and minutes for the duration of the Customised TBR. To save your settings for the Customised TBR without starting it, tap Save. The newly programmed Customised TBR appears in the list of Temporary Basal Rates. Tap Save. 176 man_07866364001_A_en.indb 176 28.07.2017 12:17:13 8.4.3 Activating a TBR 1 2 3 4 Temporary Basal Rates 8 To save and start the TBR straight away, tap Activate. To activate a saved TBR, tap the desired entry in the list of Temporary Basal Rates. To confirm this step and start the TBR, press the insulin button lit up in green below the diabetes manager screen. The activated TBR is displayed on the Status screen. man_07866364001_A_en.indb 177 177 28.07.2017 12:17:14 Basal Rate Profiles and Temporary BasalRates 8.4.4 Cancelling a TBR 1 2 3 Tap Cancel TBR?. Tap Yes. The active TBR is cancelled. The TBR is deleted from the Status screen. 178 man_07866364001_A_en.indb 178 28.07.2017 12:17:14 9 Replacing System Components 9 In this chapter you will learn how and when the infusion assembly, the reservoir and the pump base should be replaced. The system components must be disposed of according to local regulations after use. Replace the system components early in the morning so that you can check your blood glucose level 1 to 3 hours later. The following table contains guidelines on the period of use of these system components:

System component To be replaced Pump base every 4 months (maximum 120 days) Reservoir every 3-4 days (maximum 96 hours) Infusion assembly every 2-3 days (maximum 72 hours) Note j When system components are replaced, the micropump is automatically stopped. Note that this cancels any ongoing boluses and Temporary Basal Rates. If you want to avoid this, delay system component replacement to a later point in time. j The average life expectancy of the battery used to supply the micropump with power is 4 days. j You will find animated videos on replacing system components and operating the micropump in the Main menu of the diabetes manager under the Help menu item. man_07866364001_A_en.indb 179 179 28.07.2017 12:17:14 Replacing System Components 9.1 Starting the Replacement 1 or 9.2 Replacing the Infusion Assembly Have the following system components at hand for this process:

j Micropump holder j Cannula j Insertion device j Diabetes manager j Disinfectant or sterile alcohol wipe Start the infusion assembly replacement process by tapping the reservoir symbol in the Main menu. on the Status screen or the Replace menu Note that any ongoing boluses and Temporary Basal Rates will be cancelled and must be programmed again. Always start as follows when replacing the infusion assembly, reservoir or pump base:

On the Status screen, tap the area showing the reservoir symbol. or In the Main menu, tap the Replace menu. 180 man_07866364001_A_en.indb 180 28.07.2017 12:17:14 1 2 Removing the used infusion assembly 3 4 Starting the Replacement 9 The display for selecting the system components appears. Tap Replace. Tap Infusion assembly. The micropump will be stopped. Press the flap to detach the micropump and remove the pump from the infusion assembly. Remove the infusion assembly by loosening the edges of the adhesive pad and pulling it off to the centre. man_07866364001_A_en.indb 181 181 28.07.2017 12:17:15 Replacing System Components 5 6 j Check the pulled out cannula to ensure that it has been completely removed. j If you dampen the infusion assembly with warm water or apply an oily ointment, it becomes easier to pull off the adhesive pad. j Before you attach the infusion assembly to the body, the new infusion site must be completely dry. j A new infusion site should be at least 5cm away from the last infusion site. Dispose of the used infusion assembly according to local regulations. If you want to see a video on how to replace the infusion assembly, tap Help. Tap Done. Tap Done when you have finished the handling step shown on the screen. 182 man_07866364001_A_en.indb 182 28.07.2017 12:17:16 Attaching the infusion assembly to the body 7 8 9 Starting the Replacement 9 See Chapter 4 in this Users Manual. Follow the handling step instructions in the section Attaching the infusion assembly to the body. Attach the micropump to the infusion assembly. Tap Next. The infusion assembly is filled. Also observe the warnings and notes given in this chapter as well as the instructions on the screen of the diabetes manager. To confirm this step and then restart the micropump and return to the Status screen, press the insulin button lit up in green diabetes manager screen. below the man_07866364001_A_en.indb 183 183 28.07.2017 12:17:16 Replacing System Components 9.3 Replacing the Reservoir Have the following at hand for this process:

j Reservoir assembly j Insulin vial with U100 insulin j Disinfectant or sterile alcohol wipe Always fill the reservoir with at least 80U. The reservoir has a maximum holding capacity of 200U (2.0ml). Initiate reservoir replacement by tapping the reservoir symbol on the Status screen or the Replace menu in the Main menu. Note that any ongoing boluses and Temporary Basal Rates will be cancelled and must be programmed again. Front and back view of the reservoir assembly Filling aid Reservoir Protective film for battery Handle for piston rod 184 man_07866364001_A_en.indb 184 28.07.2017 12:17:16 1 2 Removing the reservoir 3 4 Replacing the Reservoir 9 The display for selecting the system components appears. Tap Replace. Tap Reservoir. The micropump will be stopped. Press the flap to detach the micropump and remove the pump from the infusion assembly. Remove the used reservoir from the pump base. man_07866364001_A_en.indb 185 185 28.07.2017 12:17:17 Replacing System Components 5 6 7 Replacing the reservoir See Chapter 4 in this Users Manual. Dispose of the used reservoir according to local regulations. Tap Done. If you want to see an animated video on how to replace the reservoir, tap Help. Once you have completed the steps shown on the display, tap Done. 186 insulin Follow the instructions in the sections:

j Filling a new reservoir with j Connecting the reservoir to the pump base j Setting the reservoir fill amount j Filling the reservoir needle j Attaching the Micropump j Activating the basal rate profile man_07866364001_A_en.indb 186 28.07.2017 12:17:18 Replacing the Pump Base 9 Note j Refer to the information in Chapter 4 Putting the Micropump Into Operation. j When you replace the micropump, all pump settings saved in the diabetes manager are preserved. j Order a new pump base in time before the operating life expires so that you always have a spare pump base available. 9.4 Replacing the Pump Base The pump base can be used for approximately 4 months. It must not be used for longer than that because otherwise the delivery accuracy may be impaired. You will be reminded regularly to replace the pump base before the deadline expires. For information on the remaining running time of the micropump, seethe settings in the System information menu. If you replace the pump base, you must also replace the reservoir. Before starting this process, have the following components ready:

j A new pump base j A new reservoir assembly j An insulin vial with U100 insulin j Disinfectant or a sterile alcohol wipe Always fill the reservoir with at least 80U. The reservoir has a maximum holding capacity of 200U (2.0ml). Initiate pump base replacement by tapping the reservoir symbol Main menu. on the Status screen or the Replace menu in the man_07866364001_A_en.indb 187 187 28.07.2017 12:17:18 Replacing System Components 1 2 Removing the pump 3 4 The display for selecting the system components appears. Tap Micropump base. The reservoir is automatically selected as well. The display showing the selected system components appears. Tap Replace. The micropump will be stopped. Press the flap of the infusion assembly. Remove the used micropump from the infusion assembly. Dispose of the used reservoir and the used pump base according to local regulations. Tap Done. 188 man_07866364001_A_en.indb 188 28.07.2017 12:17:18 Replacing the Pump Base 9 5 6 See Chapter 4 in this Users Manual. Follow the instructions on the screen. Tap Done. Follow the handling step instructions in the sections:

j Filling the reservoir with insulin j Connecting the reservoir to the pump base j Pairing the diabetes manager and micropump j Setting the reservoir fill amount j Filling the reservoir needle j Attaching the micropump j Activating the basal rate profile man_07866364001_A_en.indb 189 189 28.07.2017 12:17:18 Replacing System Components 190 man_07866364001_A_en.indb 190 28.07.2017 12:17:18 10 My Data 10.1 Overview 10.2 Logbook 10 Analysing your therapy data saved in the diabetes manager is an effective way for you and your healthcare professional to determine how your diabetes is developing. This analysis is a valuable tool for making improvements to the treatment of your diabetes. You can display 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 or add logbook entries. The diabetes manager generates charts and reports to help you analyse the information saved in the device. Each event in the logbook can be viewed separately. The diabetes manager can also display compilations of therapy data in the form of charts and overviews. The logbook saved in the diabetes manager replaces the handwritten blood glucose diary you may have kept in the past. The diabetes manager automatically stores up to 5,000 logbook entries with the time and date. You can view the most recent 250 logbook entries in the diabetes manager. If you are using a PC with compatible software, you can view all logbook entries. A logbook entry can contain the following:

date and time, blood glucose result, time of test, carbohydrate intake, health events, bolus amounts, bolus type and notes man_07866364001_A_en.indb 191 191 28.07.2017 12:17:18 My Data Note the following:

j The Logbook display shows the entries in the order in which they occurred with the most recent entry shown on top. j Blood glucose results cannot be entered manually or be j Before reviewing logbook entries on a PC, you first have to transfer the saved logbook entries to a PC that has specific diabetes management software. j Logbook data that has been used for bolus advice cannot be subsequently adjusted. subsequently adjusted (except notes). j If you want to add data to a logbook entry, you can also tap the Add data button on the Status screen or in the Main menu. j Bolus data from the micropump is automatically saved on the diabetes manager. However, the bolus advice feature will initially treat quick boluses that you deliver spontaneously as correction insulin. Therefore, you should edit the quick boluses recorded in the logbook with regard to bolus distribution (meal/

correction insulin) and carbohydrates consumed. j You should enter any boluses that were delivered independently of bolus advice using an insulin pen or syringe as new data in the logbook. j The information remains saved in the logbook when the rechargeable battery is replaced. You must, however, check whether the time and date of the diabetes manager are still correct after replacing the battery. j Once 5,000 entries have been saved in the logbook, adding a new entry causes the oldest logbook entry to be deleted. Save the entries on a PC if you want to keep all entries. j Although control results are saved in the diabetes manager, they can only be viewed on a computer with suitable software. 192 man_07866364001_A_en.indb 192 28.07.2017 12:17:18 10.2.1 Understanding the Logbook Main menu > My data > Logbook 1 2 3 Logbook 10 1 Column for displaying blood glucose information Blood glucose result range and blood glucose result. 2 Column for displaying bolus information Bolus type, bolus advice and bolus amount. 3 Column for displaying carbohydrate information Symbol for carbohydrates and carbohydrate amount. 4 Symbol for blood glucose result range information G F E D C B 9A 8 man_07866364001_A_en.indb 193 4 5 6 7 5 Symbol for bolus type 6 Symbol for bolus advice 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 general time of test 14 Symbol for note 15 Time of entry 16 Date of entry 193 28.07.2017 12:17:19 My Data Symbol Symbol name Description Blood glucose result range The symbol colours have the following meaning:

Blue Yellow

: above the target range; green

: below the target range; red

: within the target range

: below the hypo warning limit Standard bolus Extended bolus Multiwave bolus Basal insulin Bolus insulin from a standard bolus Bolus insulin from an extended bolus Bolus insulin from a multiwave bolus Basal 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 Time of test Health event Pump stopped Notes Carbohydrate data exists for the logbook entry. Data regarding the time of test exists for the logbook entry. Health event data exists for the logbook entry. The micropump was stopped. You entered a note. 194 man_07866364001_A_en.indb 194 28.07.2017 12:17:20 10.2.2 Viewing and Adjusting Logbook Data 1 2 Time of test 3 Carbohydrates 4 Logbook 10 Scroll the display upwards or downwards to view additional logbook entries. After tapping a logbook entry, the Logbook entries display shown above appears. On the Logbook entries display, tap Time of test. Tap a time of test (for example, Before meal). Tap a logbook entry if you want to view or adjust the details. Tap the entry you want to view or adjust. Tap Save. On the Logbook entries display, tap Carbohydrates. Enter the amount of carbohydrates you consumed. Tap Save. man_07866364001_A_en.indb 195 195 28.07.2017 12:17:20 My Data Health events 5 Bolus 6 7 Note 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. On the Logbook entries display, tap Health events. On the Logbook entries display, tap Bolus. Tap the appropriate entries. You can select up to 4 health events. The display informs you about the bolus delivered. Tap OK. Tap Save. 196 On the Logbook entries display, tap Note. Type a note to save with this entry. Tap

. man_07866364001_A_en.indb 196 28.07.2017 12:17:21 10.2.3 Adding New Data 1 2 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. On the Logbook display, tap to add new data to the logbook. Tap the entries you want to add. Note the instructions on the next pages. Then tap Save. man_07866364001_A_en.indb 197 Logbook 10 197 28.07.2017 12:17:21 My Data 10.3 Trend Graph The diabetes manager uses the trend graph to display your blood glucose trends, basal rates, boluses, carbohydrates and other information. The logbook entries for the time period selected by buttons, you can move backwards you are used. Using the or forwards in time according to the selected time scale. B A 9 8 7 198 1 2 3 4 5 6 1 Time period 2 Events 3 Basal rate 4 Bolus 5 Blood glucose result 6 Carbohydrates Illustrated time period Displays health events or indicates that the micropump was stopped. Blue line: The distance from the top edge of the graph shows the basal rate. Pink bars: Show the amounts of bolus insulin Crosses (x): Individual blood glucose results that are connected by lines Brown bars: Show the carbohydrate amount consumed 7 Hypo warning limit Red line: Warning limit for 8 Value below target range 9 Blood glucose target range 10 Hyper warning limit 11 Selected time of test hypoglycaemia Yellow line: Limit value for values that are below the target range but that are still above the hypo warning limit. Green area: Range between the lower and upper blood glucose threshold Blue line: Warning limit for hyperglycaemia Displays the logbook entries made for this time of test. man_07866364001_A_en.indb 198 28.07.2017 12:17:21 Basal insulin amount Bolus values Trend Graph 10 On the upper left side (U) of the graph, the basal amount is displayed. By means of the scale, you can read the basal insulin amounts, which are represented by the blue basal insulin line. Scaling depends on the largest basal insulin amount delivered during the selected time period. Example The scale comprises a range of 1, 2, 5, 10, 20 and 40U. For example, if the largest basal insulin amount in the selected time period is 3U, the scale will show the range from 0 to 5U. 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 selected time period. Blood glucose results Time scale Carbohydrate amount man_07866364001_A_en.indb 199 199 28.07.2017 12:17:22 My Data On the upper right side (U) of the graph, the bolus amount is displayed. By means of the scale, you can read the bolus values of the pink bars. Scaling depends on the largest bolus delivered during the selected time period. 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. Scaling depends on the largest carbohydrate amount consumed during the selected time period. Example The scale comprises a range of 1, 5, 15, 30 or 60U. For example, if the largest bolus delivered during the selected time period is 8U, the scale will show the range from 0 to 15U. Example The scale comprises a range of 40, 80, 120, 160, 200 and 240g, or the equivalent scale for BE, KE or CC. For example, if the largest carbohydrate amount in the selected time period is 86g, the scale will show the range from 0 to 120g. 200 man_07866364001_A_en.indb 200 28.07.2017 12:17:22 10.3.1 Viewing the Trend Graph 2 1 Time scale 3 Graph options 4 Trend Graph 10 to change the trend Tap graph representation. Tap the setting you want to change. Tap the desired time period. Tap Save. Tap one or more of the available graph options (for example, Bolus) to be displayed in the graph. Tap Save. man_07866364001_A_en.indb 201 201 28.07.2017 12:17:22 My Data Time of test 5 On the Time of test display you can select which logbook entries are to be represented. Only the logbook entries are displayed for which you entered a certain time of test. Tap the appropriate time of test (for example, After meal). Tap Save. 202 man_07866364001_A_en.indb 202 28.07.2017 12:17:23 10.4 Standard Week Standard week graph The diabetes manager uses the standard week graph to display your blood glucose averages, the individual tests and the standard deviations for the days of a standard week. Using the buttons, you can move backwards or forwards in time according to the selected time scale. 1 7 man_07866364001_A_en.indb 203 2 3 4 5 6 Standard Week 10 1 2 Time period Selected time of test 3 Warning limit for hyperglycaemia Represented time period, for example, 7 days Displays the logbook entries made for this time of test. Red line: Hyper warning limit 4 5 6 7 x x Average Single blood glucose results Blood glucose unit of measurement mmol/L Day of week Monday to Sunday The standard deviation 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. 203 28.07.2017 12:17:23 1 2 3 4 5 6 7 8 Time period Selected time of test Day of week Lowest blood glucose result of the day of the standard week Blood glucose average of the day of the standard week Highest blood glucose result of the day of the standard week Standard deviation (SD) of the day of the standard week Number of tests on the day of the standard week My Data to switch to the standard week table. The standard week Standard week table Tap table displays the data of the standard week graph in table format. To return to the standard week graph, tap

. Using the buttons, you can move backwards or forwards in time according to the selected time scale. 1 2 Table?

204 43 5 6 7 8 man_07866364001_A_en.indb 204 28.07.2017 12:17:23 10.4.1 Displaying and Configuring the Standard Week 1 2 Time scale 3 Time of test 4 Standard Week 10 to change the settings Tap that determine how your standard week data is displayed in the graph. Tap one of the entries available for selection. Make the desired settings. Tap the desired time period. Tap the appropriate time of test. Tap Save. Tap Save. Tap Done. man_07866364001_A_en.indb 205 205 28.07.2017 12:17:24 1 2 3 4 5 Time period Illustrated time period Selected time of test Target range chart Percentage distribution Blood glucose result ranges Displays the logbook entries made for this time of test. Shows the target ranges of blood glucose results as a pie chart. Shows the percentage of blood glucose results in each blood glucose result range. Coloured representation of the blood glucose result ranges My Data 10.5 Target Range The diabetes manager displays a pie chart and a table illustrating your blood glucose results for the time period and time of test you selected. The chart is divided into the following blood glucose result ranges: Above, Within, Below and Hypo. Using the buttons, you can move backwards or forwards in time according to the selected time period. Target range chart 1 206 2 3 4 5 man_07866364001_A_en.indb 206 28.07.2017 12:17:24 to switch to the target range table. The target range table Tap displays the target range data in table format. To return to the target range chart, tap backwards or forwards in time according to the selected time period. buttons, you can move

. Using the Target range table 1 6 5 man_07866364001_A_en.indb 207 2 3 4 Target Range 10 1 2 3 4 5 6 Time period Illustrated time period Buttons for scrolling left or right Blood glucose result ranges Target range table Number Times of test Moves forwards or backwards in time according to the selected time period. Coloured representation of the blood glucose result ranges Shows the logbook entries for this time of test. 207 28.07.2017 12:17:24 My Data 10.5.1 Displaying and Configuring Target Range Data 1 2 Time scale 3 Time of test 4 to change the settings Tap that determine how your target range data is displayed in the chart. Tap one of the entries available for selection. Tap the desired time period. Tap the appropriate time of test (for example, Bedtime). Make the desired settings and then tap Done. Tap Save. Tap Save. 208 man_07866364001_A_en.indb 208 28.07.2017 12:17:25 10.6 BG Averages Table The BG averages table displays your blood glucose averages and standard deviations (SD) for the time period and time of test you selected. Blood glucose averages table 2 1 6 1 2 3 4 5 6 Time period Buttons for scrolling left or right Number of tests Blood glucose standard deviation Blood glucose average Times of test BG Averages Table 10 Illustrated time period Moves forwards or backwards in time according to the selected time scale. Used to calculate the averages and standard deviation of each time of test. Data for all test results that are marked with the respective symbol for a certain time of test. 5 4 3 man_07866364001_A_en.indb 209 209 28.07.2017 12:17:26 My Data 10.6.1 Viewing the BG Averages Table 1 2 3 to change the settings Tap for the time period or time of test. Tap the desired time period. Tap Save. Tap the appropriate time of test (All, Before meal, After meal, Bedtime, Fasting or Other). Tap Save. 210 man_07866364001_A_en.indb 210 28.07.2017 12:17:26 11 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. 11 Changing Settings In the Settings menu, you can make changes to the factory settings or change the settings you made. This allows you to adjust the micropump system to your individual treatment requirements and your personal preferences. For information on changing time blocks, health events and on settings for insulin sensitivity, carbohydrate ratio, meal rise, snack size, acting time and offset time, see the chapter Bolus Advice. For information on reminder settings , see the chapter Reminders. man_07866364001_A_en.indb 211 211 28.07.2017 12:17:26 Changing Settings 11.1 Making Settings Main menu > Settings wWARNING The therapy settings must be specified by your healthcare team and you may only change them after prior consultation. Otherwise, there is a risk of experiencing hyper- or hypoglycaemia. 1 2 In the Main menu, tap the Settings menu. Scroll the list upwards to view additional list entries. Tap the desired entry to change the respective settings. 212 man_07866364001_A_en.indb 212 28.07.2017 12:17:27 11.1.1 Warning Limits Main menu > Settings > Warning limits 1 Upper limit value 2 Making Settings 11 You can set blood glucose warning limits for hypoglycaemia or hyperglycaemia. When your blood glucose result is below the hypo warning limit or above the hyper warning limit, the diabetes manager displays an appropriate warning. Tap Upper warning limit or Lower warning limit. and Use warning limit (hyper). to set the Upper Tap Save. 213 28.07.2017 12:17:27 man_07866364001_A_en.indb 213 Changing Settings Lower limit value 1 2 1 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. Tap to return to the list of settings. If you want to make additional settings, tap the respective entry. Tap Micropump remaining running time. and Use warning limit (hypo). to set the Lower Tap Save. 214 man_07866364001_A_en.indb 214 28.07.2017 12:17:28 Making Settings 11 1 2 2 Reservoir level 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. and to set the Use number of days as of which you want to receive a warning. Tap Reservoir level. and to set the Use number of insulin units as of which you want to receive a warning. Tap Save. Tap Save. man_07866364001_A_en.indb 215 215 28.07.2017 12:17:29 1 2 Changing Settings Automatic off The automatic off function is a safety feature for emergency situations. If you have not touched any button on your micropump and not operated the diabetes manager for the specified number of hours, the micropump stops insulin delivery. In this case, it can be assumed that you are no longer able to stop the pump yourself, for example, 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. Tap Automatic off. Tap Status to turn the automatic off function on or off. 216 man_07866364001_A_en.indb 216 28.07.2017 12:17:29 3 4 5 Making Settings 11 Tap Inactivity. man_07866364001_A_en.indb 217 and to set the Use number of hours after which the micropump is to be turned off. Tap Save. Tap Done. 217 28.07.2017 12:17:30 Changing Settings 11.1.2 Time and Date Main menu > Settings > Time and date wWARNING Having the time and date set precisely is essential in order for your micropump system to function properly. A wrong time setting can have serious consequences. 1 2 Tap Time format, Time or Date to make the respective settings. Tap the desired time format, for example, 24 hours. Tap Save. Then tap Done. 218 man_07866364001_A_en.indb 218 28.07.2017 12:17:30 3 4 5 Making Settings 11 and to set the hours Use and minutes for the current time. and Use month and year. to set the day, Tap Save. Tap Save. man_07866364001_A_en.indb 219 Then tap Save. 219 28.07.2017 12:17:31 Changing Settings 11.1.3 Bolus Settings Main menu > Settings > Bolus settings This section provides information on the following settings:

j Quick bolus buttons j Maximum quick bolus j Quick bolus increment j Maximum bolus amount j Delivery lag time Note If you turn off bolus advice, it must be set up again after turning it on the next time. Quick bolus buttons A quick bolus is a bolus that can be programmed and delivered using the quick bolus buttons on the micropump. 2 The factory setting for the quick bolus buttons is on. For more information on the quick bolus, see the section Quick Bolus in the chapter Delivering a Bolus. Tap Quick bolus buttons to activate or deactivate the quick bolus buttons of the micropump. If you activate the Quick bolus buttons, you can program and deliver a quick bolus directly from the micropump, for example. 220 man_07866364001_A_en.indb 220 28.07.2017 12:17:31 Making Settings 11 Maximum quick bolus You use this setting to define the maximum insulin amount that may be delivered with a quick bolus. 1 2 Note You cannot define a maximum quick bolus that is greater than the maximum bolus. Tap the Maximum quick bolus entry to set the maximum bolus amount that can be programmed. and Use to set the maximum amount for the quick bolus. Tap Save. man_07866364001_A_en.indb 221 221 28.07.2017 12:17:32 Changing Settings Quick bolus increment The quick bolus increment indicates the amount by which your insulin dose is increased with each press of the quick bolus buttons while programming a quick bolus. You can set the following quick bolus increments:

0.2 U 0.5 U 1.0 U 2.0 U Note down the set quick bolus increment in the log Settings for the Accu-Chek Solo micropump system. Example You have set a quick bolus increment of 0.2U. If you want to program a bolus of 2.0U using this increment, you must press the quick bolus buttons on the micropump 10 times. 222 1 2 Tap Quick bolus increment. Tap the desired Quick bolus increment. Tap Save. man_07866364001_A_en.indb 222 28.07.2017 12:17:32 Making Settings 11 1 2 Maximum bolus amount This setting specifies the maximum insulin amount that may be delivered in any bolus. A bolus that exceeds the maximum bolus amount requires additional confirmation or must be reduced. Note For the maximum bolus, you can set an amount between 0U and a maximum of 25U in increments between 0.05U and 1.0U (depending on the total amount). Tap Maximum bolus amount to set the maximum insulin amount for a bolus. and to set the Use maximum bolus amount. Tap Save. man_07866364001_A_en.indb 223 223 28.07.2017 12:17:33 Changing Settings Delivery lag time In some situations (for example, if you have gastroparesis) it may be helpful to only start a meal bolus after you have started eating. For each meal bolus, you can use the delivery lag time setting to specify a delay of up to 60 minutes between programming a bolus and the actual start of bolus delivery. 1 Note You can set the desired duration when programming a bolus. You can set a duration of 0, 15, 30, 45 or 60 minutes. Delivery of a bolus that contains correction insulin cannot be delayed. Tap Delivery lag time to turn the feature for delaying bolus delivery on or off. 224 man_07866364001_A_en.indb 224 28.07.2017 12:17:33 11.1.4 Tone and Vibration Main menu > Settings > Tone and vibration 1 Signal modes 2 Making Settings 11 You can define how the diabetes manager should attract your attention in case of an event (for example, a warning). You can choose whether the diabetes manager issues an acoustic signal, vibrates or both. The settings you make are called signal mode in the rest of this Users Manual. You can also suspend the signals for warnings for a specific period of time (for example, over night). You can make the tone and vibration settings in the Settings menu in menu under the Tone and vibration entry. The Signals the Main menu allows you to easily access the appropriate Signal mode and the Turn off signals feature. You can select the Quiet signal mode in a quiet environment, for example. Tap Tone and vibration. Tap Loud, Normal, Quiet or Vibration to set the desired signal mode. Then tap Done. man_07866364001_A_en.indb 225 225 28.07.2017 12:17:34 Changing Settings Volume 3 Vibration 4 Blood glucose test 5 Note When the volume slider is set to 0 percent in the far left position, vibration is automatically turned on. Set the volume for the default setting by moving the slider to this position: Loud to the right-hand side, Normal to the centre or Quiet to the left of the centre. Turn vibration on or off. Tap Save. 226 Tap Vibration. The volume slider is on the far left. Tap Save. Tap Blood glucose test to turn the signals for a blood glucose test on or off. When you have made the desired setting, tap Done. man_07866364001_A_en.indb 226 28.07.2017 12:17:35 Touchscreen feedback 6 7 Insulin delivery signal 8 Making Settings 11 Note Signals during a blood glucose test:

j Insert test strip j Blood application detected j Test completed Tap Touchscreen to set how the diabetes manager reacts when you make a selection using the touchscreen. When you have made the desired setting, tap Done. Tap the desired touchscreen setting. Tap Save. Tap Insulin delivery signal. If you turn on the signal, the diabetes manager issues a signal when you confirm delivery of a basal rate or bolus. Tap Done. man_07866364001_A_en.indb 227 227 28.07.2017 12:17:36 Changing Settings Note Signals for system messages:

j USB plug connected to USB socket j USB plug removed from USB socket j Diabetes manager restart j Bluetooth communication completed 11.1.5 Turning Off Signals You can turn off the signals for warnings for a certain period of time. However, since error and maintenance messages require your immediate attention, you cannot suspend the signals for these events. You can set up signal deactivation as a one-time event or as an event that is repeated at the same time every day. 1 Note Warnings that occur while the signals are turned off are displayed once the diabetes manager is turned on or the signal deactivation period ends. In the Main menu, tap Signals. 228 man_07866364001_A_en.indb 228 28.07.2017 12:17:36 2 3 4 5 Making Settings 11 Tap Turn off signals. Tap the Status switch to turn on the Turn off signals feature. Tap Start time to set the start of signal deactivation. and Use to set the hours and minutes for the start time. Tap Save. man_07866364001_A_en.indb 229 229 28.07.2017 12:17:37 Changing Settings 6 7 8 Tap End time to set the end of signal deactivation. and Use to set the hours and minutes for the end time. Tap Save. Tap Frequency to set the repetition interval for turning off the signals. Tap Done. Note With the Once setting, the signals for warnings are turned off only once for the time period you specified. With the Repeat setting, the signals for warnings are turned off daily in the time period you specified. Once the signal deactivation time has expired, the signals for the warnings that occurred are issued again. 230 man_07866364001_A_en.indb 230 28.07.2017 12:17:38 11.1.6 General Settings Main menu > Settings > General settings Language 1 2 Making Settings 11 You can make the following settings in the General settings:

j Language You can select the language for the texts displayed on the screen from a predefined list of languages. j Brightness You can adjust the brightness of the diabetes manager screen for different lighting conditions. j Check system functions For more information, see the chapter Care and Maintenance. Tap Language or Brightness to make the desired settings. Tap the entry for the language in which you want the menus and texts to appear on the screen. man_07866364001_A_en.indb 231 231 28.07.2017 12:17:38 Changing Settings Brightness 1 2 Tap Done to return to the list of settings. Set the Brightness of the screen. Move the slider to the left to decrease the Brightness or to the right to increase the Brightness. Tap Save. 232 11.1.7 Screen Lock Main menu > Settings > Screen lock The diabetes manager is equipped with a screen lock, which can be used to protect the device against unauthorised access. You can define a personal identification number (PIN) to be used for access. The PIN is a secret number with four to eight digits that you can enter and change in the Screen lock menu. By factory default, the PIN is 0000. wWARNING To prevent unauthorised access, you should always leave the screen lock turned on. Note j The screen lock is turned on by factory default. j Choose a PIN that you can easily memorise and enter. man_07866364001_A_en.indb 232 28.07.2017 12:17:38 1 Turning off the screen lock 2 3 Note If you want to change the PIN, you have to turn the screen lock off and on again. Making Settings 11 Tap Screen lock. Tap Status (PIN) to turn off the screen lock. man_07866364001_A_en.indb 233 When you turn off the screen lock, the above display appears for your information. Tap Yes if you do not want to enter a PIN or want to change the PIN. 233 28.07.2017 12:17:39 Changing Settings Turning on the screen lock 4 Entering the PIN 5 Confirming the PIN 6 Note If you have forgotten your PIN, you have to enter the PIN unlock code instead of the PIN to unlock the diabetes manager. You will find the PIN unlock code on the back of this Users Manual. Tap Status (PIN) to turn on the screen lock. Enter a PIN with 4 to 8 digits. Enter the PIN again to confirm it. Tap Save. Tap Save. 234 man_07866364001_A_en.indb 234 28.07.2017 12:17:40 Changing the background image 1 1 Tap Background image to set the pattern for the background image of the active screen lock. Then tap Done. Tap the tile with the desired background image. Tap None if you do not want to have a background image. Tap Done. man_07866364001_A_en.indb 235 Making Settings 11 11.1.8 System Information Main menu > Settings > System information The system information provides various details on the micropump system:

j Serial number of the diabetes manager j Firmware of the diabetes manager j Firmware of the blood glucose meter in the diabetes manager j Radio frequency signal of the RFI firmware j Selected language j Status of rechargeable battery j Date of manufacture j Diabetes manager hardware update j Number of resets/times switched on/off j Number of blood glucose tests/control tests j Serial number, micropump battery status, firmware version of micropump 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 requested by your Customer Support and Service Centre. 235 28.07.2017 12:17:40 Changing Settings 1 2 3 4 Tap System information. The list of System information is displayed. Scroll the display upwards to see additional System information. Tap the Legal information entry to view the stored license agreements. Scroll the display upwards to be able to read more text. to return to the Tap previous display. 236 man_07866364001_A_en.indb 236 28.07.2017 12:17:41 Travelling and Flight Mode 11 11.2 Travelling and Flight Mode Time zone changes Flight mode Having the date and time set accurately is very important for the Accu-Chek Solo micropump system to work correctly. If you travel across different time zones, you may need to adjust the time setting and also possibly the date. Discuss the settings that must be changed for your journey to other time zones with your healthcare team in advance. For information on how to change the date and time settings of the micropump system, see the section Setting the time and date. If you change the time of the micropump system, the basal rate will be delivered according to the time set. This also holds true for changing the clocks in summer and winter time. You can turn on flight mode for flights that do not allow Bluetooth wireless technology from electronic devices. Flight mode enables the diabetes manager to comply with the airline regulations and ensures that the wireless functions of the diabetes manager cannot be used. If the quick bolus feature was activated, you can continue to deliver boluses using the quick bolus buttons on the micropump. As soon as flight mode is turned off, the diabetes manager and micropump synchronise and update the event data. For information on using the micropump system with a pen or syringe, see the chapter Injection Therapy Mode. 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. man_07866364001_A_en.indb 237 237 28.07.2017 12:17:41 Changing Settings 11.2.1 Turning On Flight Mode 1 2 3 4 In the Main menu, tap Flight mode. Tap Status so that the switch is in the ON position. Confirm the displayed information by tapping OK. Tap Done. The symbol in the status bar indicates that flight mode is turned on. No current micropump data is displayed in flight mode. 238 man_07866364001_A_en.indb 238 28.07.2017 12:17:42 1 Turning off flight mode on the diabetes manager 2 3 Travelling and Flight Mode 11 11.2.2 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. In the Main menu, tap the Flight mode menu. Tap Status so that the switch is in the OFF position. Confirm the displayed information by tapping OK. Tap Done. man_07866364001_A_en.indb 239 239 28.07.2017 12:17:43 Changing Settings Turning off flight mode on the micropump 4 5 6 7 3 10 s Press both quick bolus buttons on the micropump simultaneously 3 consecutive times within 10 seconds. When flight mode is turned off, the micropump issues a sequence of signals. Tap Next. Tap Done. Flight mode is turned off. The flight mode symbol is no longer displayed in the status bar. 240 man_07866364001_A_en.indb 240 28.07.2017 12:17:43 12 12 Reminders Main menu > Settings > Reminders Setting Explanation You can set reminders for specific appointments and events. This can be useful when you have to make specific preparations, for example, for replacing the infusion assembly. A message on the screen and a signal attract your attention to the respective reminder at the set time. You can select any tone from the option list for each reminder. In the factory settings, all reminders are deactivated. You can turn the reminders on or off by using the ON and OFF switch. Time Date This switch position indicates that the reminder is turned off (deactivated). This switch position indicates that the reminder is turned on (activated). The time of day the reminder occurs. The date the reminder occurs. You can make different settings for the various reminder types:

man_07866364001_A_en.indb 241 Remind after Period of time following an event (for example, blood glucose value being too high) after which a reminder is to occur. Tone The tone that is used for the reminder. Frequency One-time reminder or regular reminder that is to occur every day at the same time. 241 28.07.2017 12:17:44 Reminders 12.1 Types of Reminders Reminder Explanation Replace infusion assembly Reminds you to replace the infusion assembly after a specified number of days. Alarm clock/Customised The alarm clock sounds at the specified time. The alarm clock reminds you, for example, to test your blood glucose or about any other daily appointment. Test blood glucose Reminds you to test your blood glucose at a specified time. After meal Test after low blood glucose result Test after high blood glucose result Reminds you to test your blood glucose after eating if you have previously marked a blood glucose result as Before meal. The diabetes manager turns on after the specified amount of time and displays the reminder (as long as a test strip has not been inserted). Reminds you to test your blood glucose if your test result was below the hypo warning limit (

). Reminds you to test your blood glucose if your test result was above the target range (

). Missed bolus This reminder occurs if no bolus was delivered within 2hours prior to the programmed time. Inject basal insulin Reminds you to deliver basal insulin (available in injection mode only). Healthcare professional visit, Lab test 242 Reminds you of a healthcare professional visit or lab test. man_07866364001_A_en.indb 242 28.07.2017 12:17:44 Programming Reminders 12 Reminder tone 1 2 12.2 Programming Reminders Set the desired time and frequency for each reminder. If you choose Repeat, you will be reminded of the event at certain intervals, for example, daily. Some reminders only appear when certain conditions are met, for example, depending on a previous test result. You can add more reminders by tapping number of reminders has been reached, you will see the information that no more reminders can be added, instead of the

. Once the maximum symbol. By tapping

, you can delete an existing reminder. You can assign a tone from an option list to each programmed reminder. Tap in the option list to listen to the tone. Tap the desired tone to use for the reminder. Choose Once or Repeat. to listen to the tone Tap beforehand. If you choose Repeat, you will be reminded daily, every 2days or every 3 days. Tap Save. Tap Save. man_07866364001_A_en.indb 243 243 28.07.2017 12:17:44 Reminders 12.2.2 Reminder: Replace Infusion Assembly 1 2 12.2.1 Reminder: Alarm Clock 1 2 Tap Replace infusion assembly. Tap the Status switch so that it is in the ON position. Tap Recurrence, Time, Tone to make the desired settings. Once you have made all settings, tap Done. Tap Alarm clock 1. to assign a name to the Tap alarm clock reminder. 244 man_07866364001_A_en.indb 244 28.07.2017 12:17:45 Types of Reminders 12 12.2.3 Reminder: Test Blood Glucose 1 Note When you test your blood glucose, the diabetes manager dismisses any blood glucose test reminders that are pending within the next 30 minutes. If necessary, a new reminder is scheduled based on the blood glucose result. Tap Test blood glucose. 3 4 Enter a name for the alarm clock reminder using the keyboard. The name can be upto 8 characters long. Tap the Status switch so that it is in the ON position. Tap Time, Tone or Frequency to make the desired settings. Tap Done. Once you have made all settings, tap Done. man_07866364001_A_en.indb 245 245 28.07.2017 12:17:46

Reminders 2 12.2.4 Reminder: Blood Glucose Test After Meal 1 2 Note The reminder appears following a previous entry

(BG test, bolus advice) that was marked as Before meal. Tap After meal. Tap Remind after. Once you have made all settings, tap Done. Tap the Status switch so that it is in the ON position. Tap Time, Tone or Frequency to make the desired settings. Once you have made all settings, tap Done. 246 man_07866364001_A_en.indb 246 28.07.2017 12:17:47 12.2.5 Reminder: Test After Low BG 1 2 3 4 Types of Reminders 12 Tap the Test after low BG entry. Tap the Status switch so that it is in the ON position. Tap BG threshold, Remind after or Tone to make the desired settings. Once you have made all settings, tap Done. man_07866364001_A_en.indb 247 and to set the lower Use BG threshold that should be used to remind you to test your blood glucose again. and Use to set the hours and minutes for the time span after which you want to test your blood glucose again. Tap Save. Tap Save. 247 28.07.2017 12:17:48 Reminders 12.2.6 Reminder: Test After High BG 1 2 3 4 Tap the Test after high BG entry. Tap the Status switch so that it is in the ON position. Tap BG threshold, Remind after or Tone to make the desired settings. Once you have made all settings, tap Done. 248 and to set the upper Use BG threshold that should be used to remind you to test your blood glucose again. and Use to set the hours and minutes for the time span after which you want to test your blood glucose again. Tap Save. Tap Save. man_07866364001_A_en.indb 248 28.07.2017 12:17:48 12.2.7 Reminder: Missed Bolus This reminder occurs if no bolus was delivered within 2hours prior to the programmed time. You can program up to 5 reminders of the Missed bolus type. 1 2 Types of Reminders 12 Example The missed bolus reminder is programmed for 13:00. If no bolus is delivered between 11:00 and 13:00, the previously programmed reminder will occur at 13.00. If a bolus was delivered between 11:00 and 12:59, no reminder will occur. Tap the Missed bolus entry. Tap the Status switch so that it is in the ON position. Tap the Time, Tone or Frequency elements to make the desired settings. Once you have made all settings, tap Done. 249 28.07.2017 12:17:49 man_07866364001_A_en.indb 249 Reminders 12.2.8 Appointment Reminders: Healthcare 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 2 Tap Healthcare professional visit. Tap the Status switch so that it is in the ON position. Tap Time, Date or Tone to make the desired settings. Once you have made all settings, tap Done. 250 man_07866364001_A_en.indb 250 28.07.2017 12:17:49 12.3 Deleting Reminders 1 2 3 Deleting Reminders 12 Tap the reminder you want to delete, for example, Customised 1. symbol to delete Tap the the reminder. Tap Yes if you want to permanently delete the reminder now. man_07866364001_A_en.indb 251 251 28.07.2017 12:17:50 Reminders 12.4 Issuing Reminders If the diabetes manager is turned off, it will turn on at the specified time and show the respective reminder. The diabetes manager vibrates and the respective reminder is accompanied by the selected tone. The volume corresponds to the set signal mode

(see chapter Changing Settings, section Tone and Vibration). Example You now have the option of confirming the reminder or of being reminded again. If you want to be reminded again later, the reminder will be issued again after 15 minutes. 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 point in time. The reminder will be issued again in 15 minutes. 252 man_07866364001_A_en.indb 252 28.07.2017 12:17:50 13 Injection Therapy Mode 13 If you do not want to use your micropump for a while, you can switch to injection therapy mode. This could be the case, for example, if you want to temporarily or permanently go without your insulin pump during your holiday. wWARNING Discuss pausing your pump therapy with your healthcare team. Switch to alternative therapies only after consultation. When you switch to injection therapy, your diabetes manager supports you as follows:

j Bolus advice results are rounded to the increment of your pen. j You can note down your basal injections in the detailed test result and in the logbook entries of the diabetes manager. j A reminder is available that you can use to be reminded about basal insulin injections. Note j If bolus advice is used, carry out the injections in a timely fashion and using the suggested dosage. If you inject a different insulin amount, you should adjust the respective logbook entry. j Manually enter all occasional insulin amounts delivered

(without bolus advice) in the electronic logbook of the diabetes manager. j Ensure suitable storage conditions for the pump when micropump usage is temporarily discontinued. man_07866364001_A_en.indb 253 253 28.07.2017 12:17:50 Injection Therapy Mode 13.1 Removing the Micropump Temporarily Removing the micropump 1 2 When you do water sports or take a bath or shower, you must remove the micropump from the infusion assembly. Also remove the micropump before entering rooms with high temperatures

(such as a sauna or sunbed) and before taking a ride on a roller coaster. Stop the micropump before removing it; otherwise the pump will unnecessarily continue to deliver insulin. However, you should take into account for how long you stop or remove the micropump as this interrupts the insulin supply to your body. In the Main menu, tap Stop to interrupt insulin delivery. Press the flap of the infusion assembly to detach the micropump. Remove the pump from the infusion assembly. 254 man_07866364001_A_en.indb 254 28.07.2017 12:17:51 Replacing the protective caps 3 4 Removing the Micropump Temporarily 13 Place the yellow protective cap supplied onto the cannula support of the infusion assembly. Insert the grey protective cap supplied into the opening near the reservoir needle. Keep the micropump in a safe place. man_07866364001_A_en.indb 255 255 28.07.2017 12:17:51 Injection Therapy Mode 13.1.1 Activating Injection Therapy Mode 1 2 3 4 In the Main menu, tap the Settings menu. Tap the Change to injection therapy entry. If you want to switch to injection therapy, tap Yes. Tap the desired insulin increment for the pen. The functions for controlling the micropump will be turned off. Tap Save. 256 man_07866364001_A_en.indb 256 28.07.2017 12:17:52 Removing the Micropump Temporarily 13 5 6 Note While in injection mode, the insulin amount for bolus advice is rounded for the pen according to the set insulin increment. and to set the Use maximum bolus amount you want to deliver with the pen/

syringe. Tap Save. man_07866364001_A_en.indb 257 The display informs you that injection therapy mode is turned on. The current bolus settings are displayed. Tap OK if you want to continue using these settings. 257 28.07.2017 12:17:52 Injection Therapy Mode 13.1.2 Deactivating Injection Therapy Mode 1 2 3 4 In the Main menu, tap the Settings menu. Tap the Change to pump therapy entry. Tap Yes. If you want to use the micropump with the settings last saved, tap No. If you want to check the pump therapy settings, tap Yes. 258 man_07866364001_A_en.indb 258 28.07.2017 12:17:53 Injection Therapy Displays 13 13.2 Injection Therapy Displays 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. button to cancel an ongoing bolus is omitted in injection The therapy mode. Note If you tap No on the Pump mode turned on information display, a connection to the micropump last used is established and the Status screen appears on the diabetes manager. If you tap Yes on the Pump mode turned on information display, you are directed to the current pump therapy settings. You should check the settings for basal rate and bolus advice when using the injection mode for a longer period of time. If there is no reservoir on the pump base, no data connection to the micropump can be established. If you have filled a new reservoir and connected it to the pump base, the micropump is in Stop mode. In this case, you must activate the process for replacing the reservoir and infusion assembly and enter the correct reservoir fill amount in the diabetes manager. man_07866364001_A_en.indb 259 259 28.07.2017 12:17:53 Injection Therapy Mode Display elements omitted on the Status screen Symbols omitted in the Main menu Status screen in pump therapy mode. Status screen in injection therapy mode. Main menu in pump therapy mode. Main menu in injection therapy mode. Display element Status screen for injection therapy Menu icon Main menu for injection therapy Reservoir symbol is omitted Basal rate information omitted Ongoing bolus information omitted Start and Stop menu is omitted Basal rate menu is omitted Replace menu is omitted Flight mode menu is omitted 260 man_07866364001_A_en.indb 260 28.07.2017 12:17:53 Test result in detail Bolus Injection Therapy Displays 13 Test result in detail display in pump therapy mode. Test result in detail display in injection therapy mode. Bolus display in pump therapy mode. You will also see the entry field for basal insulin. Bolus display in injection therapy mode. The Cancel bolus element is omitted. You cannot create any customised boluses. man_07866364001_A_en.indb 261 261 28.07.2017 12:17:54 Injection Therapy Mode Reminders Warning limits Reminders display in pump therapy mode. Reminders display in injection therapy mode. Warning limits display in pump therapy mode. Warning limits display in injection therapy mode. Instead of the Replace infusion assembly reminder, the Inject basal insulin reminder appears. The Micropump remain. running time (days) and Reservoir level elements are omitted. 262 man_07866364001_A_en.indb 262 28.07.2017 12:17:54 My data Bolus advice Injection Therapy Displays 13 Logbook entries display in pump therapy mode. Logbook entries display in injection therapy mode. Bolus advice display in pump therapy mode. Bolus advice display in injection therapy mode. You can enter or change the amount of basal insulin delivered in the Basal insulin entry. The Type entry provides only the Pen option. man_07866364001_A_en.indb 263 263 28.07.2017 12:17:54 Injection Therapy Mode 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. 264 man_07866364001_A_en.indb 264 28.07.2017 12:17:54 13.3 Injection Therapy Settings 1 2 3 4 Injection Therapy Settings 13 In the Main menu, tap the Settings menu. Tap the Bolus settings entry. Tap Maximum pen bolus. and to set the Use maximum bolus amount you want to deliver with the pen/

syringe. man_07866364001_A_en.indb 265 Tap Save. 265 28.07.2017 12:17:55 Injection Therapy Mode 5 6 Tap Insulin increment. Tap the desired insulin increment for the pen. Tap Save. 266 man_07866364001_A_en.indb 266 28.07.2017 12:17:55 14 Care and Maintenance This chapter provides information on how to care for and maintain the micropump system. In the Control Tests section, you will learn how to check whether the micropump system is working properly. If a problem cannot be solved or if you have any questions about caring for and maintaining the micropump system, contact your Customer Support and Service Centre. Do not attempt to repair the diabetes manager or micropump yourself. 14 14.1 Cleaning the Micropump System Clean the micropump and diabetes manager as described on the following pages. To clean the micropump system, use only a cloth dampened with distilled water or 70% isopropanol. Clean the finger pricker according to the instructions in the respective instructions for use. wWARNING To clean the micropump system, use only distilled water or 70% isopropanol. Other cleaning agents could damage the micropump system or impair its function. Replace the consumables of the micropump system, if they are soiled. man_07866364001_A_en.indb 267 267 28.07.2017 12:17:55 Care and Maintenance Note j Avoid liquid or moisture entering the openings in the diabetes manager. j Do not spray a cleaning solution directly onto the diabetes manager or micropump. j Do not immerse the diabetes manager or micropump in liquids. 14.1.1 Cleaning the Diabetes Manager It is advisable to always keep the diabetes manager clean and clean it at regular intervals. When you clean the diabetes manager, adhere to the following guidelines to ensure optimum performance. Use only the specified cleaning agents. Do not use any abrasive substances 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. 268 man_07866364001_A_en.indb 268 28.07.2017 12:17:55 1 Cleaning the casing 2 Cleaning the screen 3 Cleaning the Micropump System 14 a) b) a) Turn off the diabetes manager. b) Close the cover of the USB socket. Remove any large contaminants with a clean cloth. Wipe the surface of the diabetes manager and the area around the test strip slot carefully with a another clean, soft and slightly dampened cloth. Wipe the screen of the diabetes manager carefully with a soft and slightly dampened cloth. Remove any remaining lint. Dry the wiped areas thoroughly. man_07866364001_A_en.indb 269 269 28.07.2017 12:17:57 Care and Maintenance 14.1.2 Cleaning the Micropump Clean your micropump before reservoir replacement is due. Clean the micropump only with the reservoir attached. Replace the reservoir afterwards. Use a soft and slightly dampened cloth to clean the micropump surface. Use only the specified cleaning agents. Use neither soap nor abrasive cleaning agents as they may cause the pump casing to become scratched, discoloured or otherwise damaged. Do not try to clean parts inside the device. Replace the micropump immediately if the casing shows chipped areas or cracks. 1 2 Remove any large contaminants with a clean cloth. Wipe the pump shield and the ventilation opening of the pump base. Wipe the surface of the micropump carefully. Check whether the ventilation opening is clean and clear. 270 man_07866364001_A_en.indb 270 28.07.2017 12:17:58 Cleaning the Micropump System 14 3 Note Cleaning the ventilation opening is important for the zinc-air battery in the reservoir to work properly. Replace the used reservoir with a new one (see the chapter Replacing System Components). man_07866364001_A_en.indb 271 271 28.07.2017 12:17:58 Care and Maintenance 14.2 Control Tests 14.2.1 Information on the Control Solution 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 you open a new test strip box. j you have left the test strip container open. j you think the test strips might be damaged. j the test strips were exposed to extreme temperatures or humidity. j you want to check the diabetes manager and test strips. j the diabetes manager has fallen on the floor. j your test result does not match how you feel. j you want to check if you are performing the test correctly. The available control solutions differ, depending on the country. The control solutions have different information printed on the labels. j Close the control solution bottle tightly after use. j Write the date you opened the control solution bottle on the bottle label. The control solution is good for 3 months from the date you opened the bottle as long as the use by date on the bottle label is not exceeded. j Do not use control solution that is past the use by date. j The control solution can stain your clothes. If you have spilled control solution on your clothes, wash them with water and soap. Instead of applying blood to the test strip, you apply glucose control solution for this control test. The diabetes manager is able to detect that glucose control solution was used and shows whether the control result falls within the correct range. The control results are not displayed in the logbook. Note Use only the Accu-Chek Aviva control solutions: Control 1 with low glucose concentration or Control 2 with high glucose concentration. 272 man_07866364001_A_en.indb 272 28.07.2017 12:17:58 14.2.2 Preparing a Control Test A control test works the same way as a blood glucose test. Instead of blood, you apply control solution to the test strip. To perform a control test, you need the following items:

j Diabetes manager j Accu-Chek Aviva test strips j Accu-Chek Aviva control solution Control 1 or Control 2 j A clean, dry paper towel Control Tests 14 Note j If a control test delivers results that are outside the specified concentration range, you cannot be sure that the diabetes manager and test strips are functioning properly. Blood glucose tests may then deliver incorrect test results. Incorrect test results may cause the wrong therapy recommendation to be made and thus result in serious adverse health effects. j If a test strip error occurs, remove and dispose of the test strip, and repeat the test with a new test strip. 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 Another way to start a control test is from the Main menu. In the Main menu, tap the Test menu. j Do not apply control solution to the test strip before you have inserted the test strip into the test strip slot. man_07866364001_A_en.indb 273 273 28.07.2017 12:17:58 Care and Maintenance 14.2.3 Performing a Control Test 1 2 3 4 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. Insert the test strip into the test strip slot of the diabetes manager, in the direction of the arrow. The Apply drop display appears. Select the control solution to test. Place the diabetes manager on a flat surface, such as a table. Use the Control 1 control solution with low glucose concentration for the hypoglycaemic range. Use the Control 2 control solution with high glucose concentration for the hyperglycaemic range. 274 man_07866364001_A_en.indb 274 28.07.2017 12:18:01 5 Applying a drop 6 7 Control Tests 14 Remove the bottle cap. Wipe the tip of the bottle with a paper towel. Squeeze the bottle until a tiny drop forms at the tip. Touch 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. man_07866364001_A_en.indb 275 275 28.07.2017 12:18:03 Care and Maintenance 8 Displaying the control result 9 10 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 Step12. Wipe the tip of the bottle with a paper towel. Cap the bottle tightly. The control result is displayed. Tap the control solution you used (for example, Control1). If the control result is within the permitted concentration range, the diabetes manager and test strips are working properly. Tap OK. 276 man_07866364001_A_en.indb 276 28.07.2017 12:18:03 11 Disposing of test strips 12 Control Tests 14 Note Outside the permitted concentration range, LO or HI means that the control result is outside the permitted range. Note the information in the section Causes of Control Tests with Errors in this chapter. 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. Remove the test strip from the diabetes manager. Dispose of the used test strip according to local regulations. Tap OK. man_07866364001_A_en.indb 277 277 28.07.2017 12:18:04 Care and Maintenance 14.2.4 Causes of Control Tests with Errors Question If the control result is outside the concentration range, check the information in this section to help solve the problem: If you cannot answer the questions in the table with Yes, correct the respective item and repeat the test. For details on the correct temperature range and storage conditions, see the chapter Technical Data. If you have observed all these items and are still experiencing implausible control results or error messages, contact your Customer Support and Service Centre. Was the drop free from any air bubbles?

Did you apply control solution only after the signal sounded and the Apply drop display appeared?

The test strip must not be moved before or during the test. Did you comply with this?

Was the test strip straight (not bent)?

Question Did you perform the test within the correct temperature range?

Did you perform the control test as instructed in the Users Manual?

Did you select the control solution on the Control test display that corresponds to the control solution you used?

Did you use a new test strip?

Is the test strip slot clean?

Did you wipe the tip of the dropper on the bottle before applying the control solution to the test strip?

Did you apply a hanging drop of control solution?

Did you apply only one drop of control solution?

Has the control solution been open for less than 3 months?

Control solutions are only good for 3 months after they have been opened. After that time control solutions must not be used any more. Did you observe the section Control solution storage and handling in the control solution package insert?

278 man_07866364001_A_en.indb 278 28.07.2017 12:18:04 Question Did you observe the storage conditions for the diabetes manager, test strips and control solutions?

Has either the use by date of the test strips or the control solution expired?

You can find the use by date on the label of the test strip container and on the label of the bottle next to the e symbol. man_07866364001_A_en.indb 279 Control Tests 14 279 28.07.2017 12:18:04 Care and Maintenance 14.3 Checking the System Functions If you cannot feel or hear the vibrations and signals of the diabetes manager 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. wWARNING The system must be working perfectly for all system messages (warnings and information, maintenance and error messages) to be issued correctly. 1 2 In the Main menu, tap the Settings menu. Tap General settings. 280 man_07866364001_A_en.indb 280 28.07.2017 12:18:04 3 Checking the screen 4 5 Checking the System Functions 14 Tap Check system functions. Tap Screen. The screen shows a sequence of colours (red, blue, green and white) in quick succession. man_07866364001_A_en.indb 281 281 28.07.2017 12:18:05 Care and Maintenance Diabetes manager signals 6 Diabetes manager vibration 7 Micropump signals 8 Note If you are using injection therapy mode, the Micropump signals entry will be deactivated and greyed out. Tap Diabetes manager signals. The diabetes manager emits signals. Tap Diabetes manager vibration. The diabetes manager vibrates. Tap Micropump signals. The micropump emits signals. 282 man_07866364001_A_en.indb 282 28.07.2017 12:18:05 15 Messages and Troubleshooting 15 There are different types of messages that the micropump system uses to inform you about the status of the micropump system, problems or errors. These messages are:

j information messages j warnings j maintenance messages j error messages All messages are described on the following pages. It is very important that you pay attention to the messages and act according to the information and instructions given on the displays. The diabetes manager can show messages on the screen and bring them to your attention by means of the signal LED as well as by tones and vibration. The LED of the diabetes manager lights up to signal warnings, maintenance messages and error messages. The micropump can signal messages by emitting tones. When messages appear on the screen, you must confirm them. Some error and maintenance messages require your immediate attention. Perform the measures displayed on the respective screens or described in this chapter. If you are unable to take care of the error or maintenance message immediately, you can temporarily mute some of these messages. Tones and vibration are then stopped for a certain time period. In this case, the message remains visible on the screen and the LED lights up. If you are unsure whether the micropump system is working properly, switch to alternative therapies according to the instructions of your healthcare professional. If the problem cannot be resolved using the suggested solutions, contact your Customer Support and Service Centre. Messages are displayed with selection or confirmation buttons in the lower part of the screen. The buttons are briefly deactivated so that you cannot inadvertently confirm a message before you have read it. man_07866364001_A_en.indb 283 283 28.07.2017 12:18:05 Messages and Troubleshooting wWARNING If you ignore or do not notice the messages of the micropump system, there is a risk of hypoglycaemia. Note Check regularly for messages of the micropump system on the screen. 284 man_07866364001_A_en.indb 284 28.07.2017 12:18:05 15.1 Information Messages Examples of information messages:

Information Messages 15 There are messages that inform you about a particular status of the micropump system or an event. You must confirm these messages with OK. In addition, there are messages that include a question to be answered with Yes or No, for example, after you have entered a blood glucose result. 1 32 4 5 1 2 3 4 5 Information on the micropump Information on the diabetes manager Title of information message Information message symbol Information or explanation Buttons (OK, No, Yes) man_07866364001_A_en.indb 285 285 28.07.2017 12:18:05 Examples of warnings:

Messages and Troubleshooting 15.2 Warning Messages Warnings inform you about the status of the micropump system or about therapy or health risks. Some warnings appear before maintenance messages occur to bring to your attention at an early stage that you will have to intervene in the near future. At the time the warning is issued, the micropump system is fully functional. When a warning is displayed, a tone specific to warnings sounds and the diabetes manager vibrates. The tone for a warning also sounds when the Turn off signals feature is turned on. 1 2 43 5 6 1 2 3 4 5 6 Warning code Warning refers to the micropump Warning refers to the diabetes manager Title of warning Warning symbol Explanation of warning or corrective measure Button for confirming the warning (OK) 286 man_07866364001_A_en.indb 286 28.07.2017 12:18:06 Code Title of warning Information/possible cause Information/possible solution Warnings triggered by the micropump Warning Messages 15 Running time of the pump will end soon The period of use of the pump base will end soon. W-25 W-31 W-32 Low level of insulin in the reservoir Battery almost empty There is only a small amount of insulin in the reservoir. The battery level is low. The openings on the micropump intended for reservoir battery ventilation are covered, which means that the zinc-air battery is only delivering limited energy to the micropump. An active Temporary Basal Rate was cancelled. W-35 Limited battery power W-36 TBR cancelled man_07866364001_A_en.indb 287 Ensure that you have a new pump base at hand as a replacement. Replace the pump base after the remaining time that is displayed. Be prepared to replace the reservoir soon. Replace the reservoir. Ensure that there is an unrestricted air supply to the reservoir and pump base. Program a new Temporary Basal Rate. 287 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of warning Information/possible cause Information/possible solution W-37 Low amount delivered W-38 W-40 Bolus cancelled Replace reservoir W-41 Micropump stopped The micropump cannot deliver the insulin amount that is programmed for the basal rate or bolus in the specified time. An active bolus was cancelled. The operating life of the reservoir will soon come to an end. The micropump has been in Stop mode for at least an hour and is not delivering any insulin. At present, the micropump can only deliver a programmed insulin amount at reduced speed. Check whether the delivered insulin amounts are sufficient for your insulin needs. Test your blood glucose more frequently. Replace your reservoir in the near future. Start the micropump if you want to continue with insulin delivery. Warnings triggered by the diabetes manager W-50 Battery almost empty The rechargeable battery level is low. Recharge the battery of your diabetes manager. 288 man_07866364001_A_en.indb 288 28.07.2017 12:18:06 Warning Messages 15 Code Title of warning Information/possible cause Information/possible solution W-71 Connection interrupted W-73 No connection to the micropump No current data from the micropump is available. The data for calculating bolus advice may not be up to date. No current data from the micropump is available. The displayed data may not be complete. W-75 Warning limit exceeded High blood glucose value W-76 HI display Your blood glucose is very high. W-80 Hypoglycaemia Blood glucose has fallen below the hypo warning limit. Ensure that the micropump and diabetes manager are no more than 2 metres apart and that there are no obstacles between them. The data is updated when the connection between the diabetes manager and the micropump is re-established. Test ketones and your blood glucose. Check insulin delivery. Follow the instructions of your healthcare professional. Test your blood glucose again and test ketones. Follow the instructions of your healthcare professional. Eat or drink fast acting carbohydrates. Then test your blood glucose. man_07866364001_A_en.indb 289 289 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of warning Information/possible cause Information/possible solution W-81 LO display W-82 Bluetooth connection deactivated W-84 Testing not possible W-85 Missing data Your blood glucose result may be very low. The Bluetooth connection to the micropump was deactivated because the rechargeable battery of the diabetes manager is almost empty. You cannot test your blood glucose while the diabetes manager is connected to a USB cable. Internal clock error or error in existing bolus data. The saved data can no longer be used to calculate bolus advice. Eat or drink fast acting carbohydrates. Test your blood glucose again immediately and then again within the next half hour. If hypoglycaemia persists, test your blood glucose and consult your healthcare professional. Recharge the battery of your diabetes manager. Remove the USB cable from the diabetes manager. 290 man_07866364001_A_en.indb 290 28.07.2017 12:18:06 Code Title of warning Information/possible cause Information/possible solution Warning Messages 15 W-86 Flight mode on Data cannot be synchronised between the diabetes manager and micropump because flight mode is turned on. Therefore, the entries saved for bolus advice may not be up to date. Bolus advice can currently only make recommendations based on the entries saved on the device. W-88 Flight mode on The saved logbook entries may not be up to date. You can still use the bolus advice feature. Note, however, that the diabetes manager is not receiving any information

(for example, errors) from the micropump. When flight mode 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. When flight mode is turned off and the diabetes manager and micropump are within communication range, the logbook entries will be synchronised. man_07866364001_A_en.indb 291 291 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of warning Information/possible cause Information/possible solution W-89 Check logbook entries W-90 Time synchronised with micropump W-92 TBR without insulin delivery A quick bolus selected in bolus advice was not confirmed by the pump and set to zero. The reason for this is that the last quick bolus was not delivered within the 15-minute timeframe after bolus advice. A time difference between the diabetes manager and the micropump was corrected. Due to the set TBR, the amount to be delivered in the current time block is so low that it falls below the smallest output (delivery amount) the pump can technically deliver. The allocation to correction bolus and meal bolus as well as the entered health events may not be correct. This may affect the next bolus advice calculations. Correct the logbook entries as required. Check the time on the diabetes manager. 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. 292 man_07866364001_A_en.indb 292 28.07.2017 12:18:06 Warning Messages 15 Code Title of warning Information/possible cause Information/possible solution W-93 Fill reservoir needle W-99 No connection to the micropump The micropump must NOT have been inserted in the micropump holder. The rechargeable battery of the diabetes manager is empty, therefore no data can be exchanged with the micropump. The data for calculating bolus advice may not be up to date. The micropump must NOT have been inserted in the micropump holder while it is being filled. Remove the micropump from the micropump holder before filling it. The diabetes manager can currently only give bolus advice based on the entries saved in the diabetes manager. man_07866364001_A_en.indb 293 293 28.07.2017 12:18:06 Messages and Troubleshooting 15.3 Maintenance Messages Maintenance messages inform you about a temporary loss of certain features of the micropump system. Maintenance messages require you to intervene in order to solve the problem. The micropump switches to Stop mode and does not deliver any insulin. Once the cause of the maintenance message has been eliminated, you can use all features of the micropump system again. When a maintenance message is displayed, a tone specific to maintenance messages sounds and the diabetes manager vibrates. The tone for maintenance messages also sounds when the Turn off signals feature is turned on. Examples of maintenance messages:

1 2 43 5 6 1 2 3 4 5 6 Code of maintenance message Maintenance activity refers to the micropump Maintenance activity refers to the diabetes manager Title of maintenance message Maintenance symbol Explanation of maintenance message or corrective measure Button to confirm (OK) or postpone the mainte-

nance message (Snooze) 294 man_07866364001_A_en.indb 294 28.07.2017 12:18:06 Maintenance Messages 15 Code Title of maintenance message Possible cause/consequences Further information Maintenance messages triggered by the micropump M-18 Replace micropump The operating life of your micropump has come to an end. Replace your micropump base and the reservoir now. M-19 Discrepancy in reservoir level M-21 Reservoir empty The entered insulin amount does not correspond to the measured reservoir level. Replace the reservoir, if required, with a new reservoir. The insulin in the reservoir has been used up. Select the Replace menu and replace the reservoir with a new one. M-22 Micropump battery empty The micropump battery, which is located in the reservoir, is empty Select the Replace menu and replace the reservoir with a new one. M-23 Automatic off M-24 Occlusion The automatic off feature has stopped insulin delivery. The micropump is in Stop mode. An occlusion was detected which means that insulin delivery is not working at all or is restricted. Start the micropump to resume insulin delivery. Remove the micropump from the infusion assembly and start filling the reservoir using the Replace menu. If no drop is visible at the reservoir needle, replace the reservoir. If a drop is visible, replace the infusion assembly. man_07866364001_A_en.indb 295 295 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of maintenance message Possible cause/consequences Further information M-26 Fill reservoir needle The reservoir needle must be refilled after replacing the reservoir. M-27 No data connection The micropump system setup was interrupted. Remove the micropump from the infusion assembly. Tap the Replace menu, select Reservoir and follow the instructions for filling the reservoir. Hold the diabetes manager close to the micropump to ensure that data is exchanged between the pump and the diabetes manager. Resume setting up the micropump system when the connection has been re-established. Replace the pump if the problem persists. Maintenance messages triggered by the diabetes manager M-51 Test strip error M-53 Test failed M-54 Drop too small The test strip is used, damaged or not completely inserted into the test strip slot. The blood glucose test did not work properly. Use a new test strip or re-insert the test strip into the test strip slot. Repeat the blood glucose test with a new test strip. The amount of blood or 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. 296 man_07866364001_A_en.indb 296 28.07.2017 12:18:06 Maintenance Messages 15 Code Title of maintenance message M-56 Drop applied too early M-58 Temperature too high or too low M-59 Battery almost empty Possible cause/consequences Further information The drop was drawn into the test strip before Apply drop appeared on the screen. The ambient temperature for testing blood glucose or performing a control test is outside the permitted range. The rechargeable battery level is very low. Repeat the test with a new test strip and a fresh blood drop or drop of control solution. Make sure the ambient temperature is within the permitted range. Wait 5 minutes before testing your blood glucose again or performing a control test. Recharge the battery of your diabetes manager. M-60 Clock error A discrepancy in the micropumps internal clocks was detected. Set the current time and the current date on the diabetes 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 the code or camera lens is dirty and the code cannot be read correctly. Try rescanning the pairing code on the micropump. man_07866364001_A_en.indb 297 297 28.07.2017 12:18:06 Messages and Troubleshooting Code M-64 M-65 Title of maintenance message Possible cause/consequences Further information Bolus delivery not possible The connection between the diabetes manager and micropump was lost. Hold the diabetes manager close to the micropump and ensure that data communication is not disrupted. You can deliver a quick bolus straight from the micropump. Bolus delivery not possible The micropump is currently in Stop mode. If you want to deliver a bolus, start the micropump first. M-67 Bolus delivery failed M-77 Operation failed There is no connection to the micropump. The requested operation failed. Try again. Hold the diabetes manager close to the micropump. You can deliver a quick bolus straight from the micropump. Outside of temperature range The temperature of the diabetes manager is too high or too low. Wait for 5 minutes until the diabetes manager has adjusted to this temperature. Temperature is at limit of range Micropump incompatible The ambient temperature is at the edge of the range permitted for blood glucose tests. You tried to pair the diabetes manager with a micropump base that is incompatible. Ensure the ambient temperature is within the permitted range before you test your blood glucose. Contact your Customer Support and Service Centre. M-78 M-84 M-85 298 man_07866364001_A_en.indb 298 28.07.2017 12:18:06 Maintenance Messages 15 Code Title of maintenance message Possible cause/consequences Further information M-86 Micropump not started The micropump cannot be started because ongoing processes have not finished yet. M-87 Micropump not stopped The micropump cannot be stopped. M-88 Flight mode turned off M-94 Connection failed M-95 No micropump located The micropump and the diabetes manager are not within communication range. Flight mode could not be turned on on the micropump. There is a communication problem between the micropump and the diabetes manager. A connection to the micropump could not be established. Check whether you need to react to prior error messages or maintenance messages. Example: The prior message was Reservoir empty

(M-21). Only after replacing the reservoir, will you be able to start the micropump. Try to stop the micropump again. Remove the micropump from the pump base if you want to interrupt insulin delivery. Hold the diabetes manager close to the micropump. Hold the diabetes manager close to the micropump and ensure that data communication is not disrupted. Check the micropump. Check whether the micropump is too far away. man_07866364001_A_en.indb 299 299 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of maintenance message M-96 USB connection failed Possible cause/consequences Further information The USB connection between the diabetes manager and the software on the computer failed. Check whether the software is correctly installed on the computer. 300 man_07866364001_A_en.indb 300 28.07.2017 12:18:06 15.4 Error Messages Examples of error messages:

Error Messages 15 When an error message is displayed, a tone specific to these messages sounds and the diabetes manager vibrates. The tone for error messages also sounds when the Turn off signals feature is turned on. The vibration feature cannot be turned off. Error messages are displayed when significant malfunctions of the micropump system are registered. The micropump switches to Stop mode. The micropump system can only be used again when the problem has been solved. For most problems, the diabetes manager displays a message with a short description of the problem and a proposed solution. This section goes into more detail describing the problem with the possible cause and suggesting possible solutions. If the problem cannot be resolved using the suggested solutions, contact your Customer Support and Service Centre. man_07866364001_A_en.indb 301 1 2 3 4 5 6 1 2 3 4 5 6 Code of error message Error refers to the micropump Error refers to the diabetes manager Title of error message Error symbol Explanation of error message Button to confirm (OK) or postpone the error message (Snooze) 301 28.07.2017 12:18:07 Messages and Troubleshooting Code Title of error Possible cause/consequences Possible solutions Error messages triggered by the micropump E-6 Mechanical error in the micropump The micropump switches to Stop mode and does not deliver any insulin. Select the Replace menu and replace the micropump and the reservoir. E-7 Electronic error E-8 Micropump battery error Communication between the micropump and diabetes manager is not possible. The micropump does not deliver any insulin. The energy supply is defective. The micropump switches to Stop mode and does not deliver any insulin. After 10 seconds the pump turns off. Select the Replace menu and replace the micropump and the reservoir. Select the Replace menu and replace the reservoir with a new one. Error messages triggered by the diabetes manager E-57 Electronic error E-60 Internal clock error 302 The electronic components of the diabetes manager are not behaving as expected. Remove the rechargeable battery from the diabetes manager and reinsert it. If the error message is displayed again, contact your Customer Support and Service Centre. Internal clock error in the diabetes manager Contact your Customer Support and Service Centre. man_07866364001_A_en.indb 302 28.07.2017 12:18:07 15.5 Troubleshooting For most problems, the diabetes manager displays a message with a short description of the problem and a proposed solution. This chapter goes into more detail describing the problem with the possible cause and suggesting possible solutions. If the problem cannot be resolved using the suggested solutions, contact your Customer Support and Service Centre. man_07866364001_A_en.indb 303 Troubleshooting 15 303 28.07.2017 12:18:07 Messages and Troubleshooting Problem Possible cause Possible solutions The screen is blank or the diabetes manager cannot be turned on. The rechargeable battery is low. Charge the battery. For more information, see the chapter Setting Up the Micropump System. 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. The ambient temperature is higher or lower than the operating temperature recommended for the diabetes manager. The screen is damaged or the diabetes manager is defective. The USB port on the PC is not supplying any charging current. Reset the diabetes manager by pressing and holding the power button for at least 5 seconds. Move the diabetes manager to an area with the suitable temperature. Wait 5 minutes before turning on the diabetes manager. Do not heat or cool the diabetes manager using any aids. Contact your Customer Support and Service Centre. Recharge the battery with a charger using a wall socket. The battery is not being charged while the diabetes manager is connected to a PC via a USB cable. 304 man_07866364001_A_en.indb 304 28.07.2017 12:18:07 Troubleshooting 15 Problem Possible cause Possible solutions The number of charge cycles for the rechargeable battery is limited. If this number is exceeded, the charge capacity is reduced and the battery must be recharged more frequently. An electronic error has occurred in the diabetes manager. The battery must be charged more often than atthe beginning. The screen freezes or does not respond. The screen is defective or the colours are not represented correctly. Replace the battery. j Reset the diabetes manager by pressing and holding the power button for at least 5 seconds until the screen turns off. j Remove the rechargeable battery from the diabetes manager and reinsert it. Perform a diabetes manager function test. For more information, see the section Checking the System Functions in the chapter Care and Maintenance of this Users Manual. If the system function test of the screen shows a problem, contact your Customer Support and Service Centre. man_07866364001_A_en.indb 305 305 28.07.2017 12:18:07 Messages and Troubleshooting Problem Possible cause Possible solutions j Check to see if the signal modes (Normal, Vibration, Quiet, Loud) have sound activated and if the volume is set at a level that is audible. For more information, see the section Tone and Vibration in the chapter Changing Settings of this Users Manual. j Check to see if the Turn off signals option is on and active. The Turn off signals option may need to be turned off or its settings adjusted. For more information, see the section Turning Off Signals in the chapter Changing Settings of this Users Manual. j Perform the system function test for the diabetes manager. For more information, see the section Checking the System Functions in the chapter Care and Maintenance of this Users Manual. If the system function test shows a problem with the signals of the diabetes manager or micropump, contact your Customer Support and Service Centre. To change the start time for the first time block, select the Reset option on the Time Blocks display. After resetting the time blocks, you must re-enter all time block information. The sound is faulty. You cannot hear the signals. The sound feature is turned off or the volume is set too low. Start time: 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. 306 man_07866364001_A_en.indb 306 28.07.2017 12:18:07 Troubleshooting 15 Problem Possible cause You cannot feel any vibrations when a signal isemitted. The vibration feature is turned off. The occlusion alarm of the micropump was triggered. The micropump was exposed to a temperature that was too low. Possible solutions Check the settings on the Tone and vibration display. The diabetes manager only vibrates if the active signal mode (Normal, Vibration, Quiet, Loud) includes vibration. Check the touchscreen settings (Tone; Vibration;

Tone and vibration; No tone, no vibration). Make sure the ambient temperature is suitable. Perform the recommended maintenance measure (see maintenance message M-24) and continue the therapy. man_07866364001_A_en.indb 307 307 28.07.2017 12:18:07 Messages and Troubleshooting 308 man_07866364001_A_en.indb 308 28.07.2017 12:18:07 16 16 Technical Data 16.1 Micropump System Technical data of the micropump system Permitted insulin types Rapid-acting U100 insulin types:

Humalog, NovoLog/NovoRapid, Apidra, Insuman Infusat Electromagnetic compatibility The micropump system meets the EMC requirements for home healthcare environments. Classified in accordance with CISPR 11, group 1, class B (residential). Safety The safety concept is based 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 of acoustic signals and messages on the diabetes manager screen. man_07866364001_A_en.indb 309 309 28.07.2017 12:18:07 Technical Data 16.2 Diabetes Manager Technical data of the diabetes manager Device type Access control Dimensions Weight Signal reproduction Screen Screen size Screen resolution Video format Audio format Screen brightness Screen orientation Screen timeout Camera 310 Accu-Chek Aviva Solo diabetes manager, model #

The Accu-Chek Aviva Solo diabetes manager is suitable for continuous operation. PIN-based protection 124 x 64 x 17mm (L x W x H) 140g Graphical user interface, status LED, loudspeaker, vibration alarm Capacitive colour LCD multi-touch screen with backlight 3.5 "

320 x 480 pixels MPEG-4 at a frame rate of 30 frames/second mp3

#

Portrait (standard) or landscape 30 sec. (screen goes dark after 15 sec., plus 15 sec. until screen times out) 2 megapixels for scanning the pairing code (2D data matrix code) at a minimum of 300 lx up to a maximum of 20,000 lx. man_07866364001_A_en.indb 310 28.07.2017 12:18:07 Technical data of the diabetes manager Data transfer between the micropump and the diabetes manager Transmission frequency Transmission power Communication range Admissible temperature range Admissible humidity range Atmospheric pressure Operating height Alarm types Sound pressure of the alarm signal Bluetooth Low Energy (BLE) wireless technology 24022480 MHz Maximum 1 mW / 0 dBm Channels: 37*FHSS + 3*DSSS advertising channels Modulation: GFSK Bandwidth: 1MHz single hop frequency

> 1.5 m (line of sight) During operation: +5C to +40C Storage between periods of use, without packaging: -25C to +70C Storage and transport, with packaging: -20C to +50C During operation: 15% to 93%

Storage between periods of use, without packaging: 5% to 93%

Storage and transport, with packaging: 5% to 85 %

During operation: 70 to 106kPa During charging: 80 to 106kPa Storage between periods of use, without packaging: 54.9 to 106kPa Storage and transport, with packaging: 54.9 to 106kPa Up to 3,000m above sea level Visual, acoustic, vibration

> 45 dB (A) at a distance of 1 m man_07866364001_A_en.indb 311 Diabetes Manager 16 311 28.07.2017 12:18:07 Technical Data Technical data of the diabetes manager Frequency Interface to PC Memory capacity Power supply Battery voltage Battery capacity Charging voltage via USB Socket adapter IP rating Protection class Bolus calculator Blood glucose meter Test strip slot Measuring range Test principle Test time Blood sample Sample type 312 13 kHz USB 2.0 (micro-B) 5,000 blood glucose tests, 5,000 logbook entries, 5,000 pump events Rechargeable lithium-ion battery 3.7 V 1,530 mAh 5 V PHIHONG switching power supply, model PSC03R-050 IP20 II in battery mode with internal power supply Accu-Chek Bolus Advisor Accu-Chek Aviva Illuminated test strip slot for Accu-Chek Aviva test strips 0.633.3 mmol/L (10600 mg/dL) Refer to the test strip package insert Refer to the test strip package insert Refer to the test strip package insert Refer to the test strip package insert man_07866364001_A_en.indb 312 28.07.2017 12:18:07 Micropump 16 16.3 Micropump Technical data of the micropump Dimensions Weight Pump casing Approx.684015mm Micropump without reservoir: approx.18g Micropump with filled reservoir and infusion assembly: approx.32g Impact and scratch-resistant plastic (polycarbonate) Quick bolus buttons Silicone buttons for delivering quick boluses and turning flight mode on/off Admissible temperature range*

Admissible humidity range Atmospheric pressure Motor type Power supply During operation: +5C to +40C Storage between periods of use, without packaging: -25C to +70C Storage and transport, with packaging: -20C to +50C During operation: 15% to 93%

Storage between periods of use, without packaging: 15% to 93%

Storage and transport, with packaging: 20% to 85 %

During operation: 70 to 106 kPa (700 to 1060 mbar) Storage without packaging: 54.9 to 106 kPa (549 to 1060 mbar) Storage and transport, with packaging: 54.9 to 106 kPa (549 to 1060 mbar) Stepper motor 1.2 V zinc-air battery for internal power supply Life expectancy of the battery If used in a typical usage pattern (50 U/day using U100 insulin; room temperature: 23C 2C), the battery life is approximately 96 hours.

* For information on the admissible temperature range for usage, storage and transport of the insulin used, see the instructions for use of the insulin manufacturer. man_07866364001_A_en.indb 313 313 28.07.2017 12:18:07 Technical Data Technical data of the micropump Basal rate Basal rate, increments Basal rate delivery accuracy Minimum: 0.1U/h Maximum: 25.0U/h 0.1U up to under 5.0U: increments of 0.01 units 5.0U up to under 25.0U: increments of 0.1 units 15% or better at 0.1U to 1.0 U 5% or better at 1.0U to the maximum Basal rate profiles Up to 5 customised profiles Temporary Basal Rate (TBR) Bolus types Bolus amount Bolus delivery accuracy 090 % for basal rate reductions and 110250 % 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. Standard bolus, quick bolus, extended bolus, multiwave bolus Minimum: 0.2U Maximum: 50U 30% or better at 0.2U up to under 1.0 U 17 % or better at 1.0U up to under 6.0 U 8.5 % or better at 50.0 U 314 man_07866364001_A_en.indb 314 28.07.2017 12:18:07 Micropump 16 Technical data of the micropump Bolus amount, increments 0.2U up to under 2.0U: increments of 0.05 units 2.0U up to under 5.0U: increments of 0.1 units 5.0U up to under 10.0U: increments of 0.2 units 10.0U up to under 20.0U: increments of 0.5 units 20.0U up to 50.0U: increments of 1.0 units The duration of an extended bolus or a multiwave bolus is adjustable 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 increments 0.2U / 0.5U / 1.0U and 2.0U Bolus delivery speed 1.02.5U/min. Sound pressure of the alarm signal

> 45 dB at a distance of 1 m Occlusion alarm Rotation detector Maximum duration until message Maintenance M24: OCCLUSION**

is displayed Maximum insulin amount until message Maintenance M24:

OCCLUSION is displayed Maximum limit value for the system warning in the event of an occlusion 50 hours 5.0U 330 kPa (3.3 bar) man_07866364001_A_en.indb 315 315 28.07.2017 12:18:07 Technical Data Technical data of the micropump Maximum pressure Reservoir Reservoir fill amount 150 kPa (1.5 bar) Fillable insulin container Maximum: 200U Minimum: 80U (12U) Maximum overdelivery in the event of an error 0.4U Remote control and data transfer Bluetooth Low Energy, ISM 2.4 GHz communication channel Communication range

> 1.5 m (line of sight) IP rating IP22 316 man_07866364001_A_en.indb 316 28.07.2017 12:18:07 Infusion Assembly 16 16.4 Infusion Assembly Technical data of the infusion assembly Micropump holder Dimensions: Approx.68401.65mm Cannula Cannula fill amount Maximum period of use Sterility Protective caps Orange, 6 mm 90 Teflon soft cannula Blue, 9 mm 90 Teflon soft cannula 0.2U 72 hours Sterilized using ethylene oxide for single use according to ISO 11135-1 Silicone caps for the reservoir and the infusion assembly man_07866364001_A_en.indb 317 317 28.07.2017 12:18:07 Technical Data 16.5 Technical Data of the Insertion Device Technical data of the insertion device Declaration of conformity Roche hereby declares that the radio equipment type Accu-Chek Solo micropump system conforms with the Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following Internet address: http://declarations.accu-chek.com 318 man_07866364001_A_en.indb 318 28.07.2017 12:18:07 17 Symbols, Abbreviations, Signals 17.1 Symbols The following symbols appear on the packaging and on the components of the micropump system:

Symbol Meaning Symbol Meaning Consult instructions for use Sterilized using ethylene oxide 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 Manufacturer Date of manufacture Catalogue number Batch code Serial number man_07866364001_A_en.indb 319 17 319 28.07.2017 12:18:08 Symbols, Abbreviations, Signals Symbol Meaning Symbol Meaning Global Trade Item Number This product fulfils the requirements of the European Directive 93/42/EEC on medical devices. This product also fulfils the requirements of the following directives:

j European Directive 2014/53/EU on the provision of radio equipment (RED). j European Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS). The FCC ID (Federal Communications Commission Identification) indicates that the radio frequency equipment has passed the equipment authorization process for the United States of America. The IC ID (Industry Canada Identification) indicates that the radio frequency equipment has passed the equipment authorization process for Canada. 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 and New Zealand market. Keep away from sunlight Keep dry Do not use if package is damaged Admissible humidity range Admissible air pressure range Do not throw away Bluetooth wireless technology 320 man_07866364001_A_en.indb 320 28.07.2017 12:18:09 Symbol Meaning IP20 IP22 Electronic device of type BF according to the standard IEC 60601-1. Non-ionizing radiation Federal law (USA) restricts this device to sale by or on the order of a physician Protected against solid foreign objects with a diameter of at least 12.5mm Protected against access with a finger Protected against solid foreign objects with a diameter of at least 12.5mm Protected against access with a finger Protected against dripping water when the casing is tilted by up to 15 Warning against device use in electromagnetic or high electrical fields or environments Device of protection class II Suitable for indoor use only man_07866364001_A_en.indb 321 Symbols 17 321 28.07.2017 12:18:09 Symbols, Abbreviations, Signals 17.2 Abbreviations Abbreviation Meaning Ante meridiem: Before midday (12-hour clock notation for times before 12 noon) Broteinheit (bread equivalent) Blood Glucose Degrees Celsius (or Centigrade) Carbohydrate Choice Diabetes manager Degrees Fahrenheit Federal Communications Commission

(United States) Gram Hour (s) Industry Canada (Canadian telecommunications authority) International Electrotechnical Commission am BE BG C CC DM F FCC g h IC IEC 322 Abbreviation Meaning ISO KE LCD mg/dL mmol/L kPa PC PIN pm SD sec. TBR International Organization for Standardization Kohlenhydrateinheit (carbohydrate unit) Liquid Crystal Display Milligrams per decilitre Millimoles per litre Kilopascal Personal Computer Personal Identification Number (secret code) Post meridiem: After midday (12-hour clock notation for times after 12 noon) Standard Deviation Seconds Temporary Basal Rate man_07866364001_A_en.indb 322 28.07.2017 12:18:09 Abbreviation U U/h U100 USB Meaning Unit (International Unit , also IU) Unit of measurement for the amount of a biologically active substance, for example insulin, referring to the biological activity. Insulin amount delivered in units per hour Insulin concentration. Each millilitre of liquid contains 100units of insulin. Universal Serial Bus man_07866364001_A_en.indb 323 Abbreviations 17 323 28.07.2017 12:18:09 Symbols, Abbreviations, Signals 17.3 Signals Many features of the micropump system are accompanied by acoustic signals. Tones and melodies are generated for this purpose. Tone Function/Meaning 324 man_07866364001_A_en.indb 324 28.07.2017 12:18:09 18 Appendix 18.1 Guarantee The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. Any changes or modifications to the micropump system not expressly approved by Roche could render your operating guarantee for the Accu-Chek Solo micropump system invalid. 18 18.2 Licence Information Licence agreement for open source software:

This product contains open source software components. For more information on open source software, see the System information item in the Settings menu of the diabetes manager. man_07866364001_A_en.indb 325 325 28.07.2017 12:18:09 Appendix 18.3 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. For contact details of the responsible customer support and service centre, see below. Do not attempt to repair or modify the components of the micropump system yourself. Our staff will help solve any problems you might be experiencing with the micropump system from Roche. Australia Accu-Chek Enquiry Line: 1800 251 816 Pump Support: 1800 633 457 www.accu-chek.com.au Distributed in the United Kingdom by:

Roche Diabetes Care Limited Charles Avenue, Burgess Hill West Sussex, RH15 9RY, United Kingdom Accu-Chek Pump Careline 1):

UK Freephone number: 0800 731 22 91 ROI Freephone number: 1 800 88 23 51 1) calls may be recorded for training purposes Some mobile operators may charge for calls to these numbers. burgesshill.insulinpumps@roche.com www.accu-chek.co.uk www.accu-chek.ie 326 man_07866364001_A_en.indb 326 28.07.2017 12:18:09 18.4 Supplies and Accessories For information on the availability of additional Accu-Chek products and accessories in your country, contact the reponsible Accu-Chek Customer Support and Service Centre. Note Use only supplies and accessories from Roche. Otherwise, you risk malfunctions of the micropump system, incorrect testresults and over- or under-delivery of insulin. man_07866364001_A_en.indb 327 Supplies and Accessories 18 Supplies for the micropump system j Accu-Chek Solo reservoir assembly j Accu-Chek Solo cannula assembly and micropump holder j Accu-Chek Solo micropump j Accu-Chek Solo insertion device Supplies for the blood glucose test j Accu-Chek Aviva test strips j Accu-Chek Aviva control solutions j Accu-Chek FastClix finger pricker j Accu-Chek FastClix lancet drums Accessories j Charging cradle for the diabetes manager j Carry case/belt pouch

(Accu-Chek carry case/Accu-Chek belt pouch) j Rechargeable battery for the diabetes manager j Battery door for the diabetes manager j Charger for the diabetes manager j USB cable If you need to replace defective system components or need another Users Manual for the micropump system, contact your Customer Support and Service Centre. 327 28.07.2017 12:18:09 Appendix 18.5 Disposing of the Micropump System wWARNING All objects which can come into contact with human bodily fluids carry a potential risk of infection. There is a risk that the objects may transmit infections. Dispose of used micropump system components because using them more than once may result in infections being transmitted. Since your micropump system may come into contact with blood 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 the diabetes manager Dispose of the battery correctly and recycle it according to local regulations. 328 man_07866364001_A_en.indb 328 28.07.2017 12:18:09

18.6 Bolus Calculation 18.6.1 Meal Bolus Bolus Calculation 18 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. If you are planning to eat several meals or snacks within a short period of time, you should deliver a meal bolus for each meal. The carbohydrate ratio is specified in insulin units (U) per carbohydrate amount, for example, 1U : 12 g. Calculation:

Meal bolus = carbohydrate amount x carbohydrate ratio Example Carbohydrate amount: 63 g carbohydrate ratio: 1/12 Meal bolus = 63 g x 1/12 = 5.25U The bolus advice feature calculates your insulin doses based on different pieces of information. Examples:

j Your current blood glucose result j Your current blood glucose target value j Your current insulin sensitivity j Your estimated carbohydrate amount for a meal j Your current carbohydrate ratio j Your current health events j Correction insulin that is still acting in the body j Your bolus and/or meal history Consider the following information when calculating bolus advice:

j How you are currently feeling: It may happen that the values entered when setting up bolus advice do not match how you are currently feeling. Increase or decrease the suggested bolus amount according to your current needs. j Bolus amounts and meals that were delivered or consumed, but not entered in the diabetes manager. j If you have delivered a bolus without using bolus advice, you can manually enter the bolus information in the electronic logbook. It is important that you enter bolus and carbohydrate information in the logbook in order to obtain accurate bolus advice recommendations. man_07866364001_A_en.indb 329 329 28.07.2017 12:18:10 Appendix 18.6.2 Correction Bolus 18.6.3 Correction Bolus After a Meal If your current blood glucose level does not match your blood glucose target value, a correction bolus is suggested. The correction bolus calculation is based on your current blood glucose result and your insulin sensitivity in the current time block. Calculation:

(Current BG - target BG) x insulin sensitivity Example Current BG: 8.3 mmol/L Target BG: 6.1 mmol/L Insulin sensitivity: 0.033 (calculated from 1U : 1.7 mmol/L) Correction bolus = (8.3 mmol/L - 6.1 mmol/L) x 0.033 = 1.3U After a meal, it is normal for your blood glucose level to increase even if you delivered the correct meal bolus. The allowed increase in the blood glucose level is called meal rise. After a certain period of time, the so-called offset time, the blood glucose level decreases slowly until it has returned to the target level. The period of time from the start of the meal rise until your blood glucose level has returned to its target level, is defined as acting time. During this time, a correction bolus is only recommended if the increase in your blood glucose level exceeds the allowed meal rise value. 330 man_07866364001_A_en.indb 330 28.07.2017 12:18:10 Bolus Calculation 18 6 7 BG 1 2 3 4 5 Bolus Advice Graph The dotted line in the adjacent graph shows how your blood glucose level might change after a meal bolus. Bolus advice tolerates an increase in your blood glucose level within the allowed meal rise range (green). If your blood glucose result is within the green range, a correction bolus will not be recommended. If your blood glucose result is above the green range, a correction bolus will be recommended. If you enter a carbohydrate amount that is greater than the snack size, the meal rise is added to the current blood glucose value. If no current blood glucose value is available, the meal rise is added to the blood glucose target value. The snack size is a small amount of carbohydrates (maximum 24grams). A meal rise will only be taken into account if the snack size is exceeded. Since the meal rise is not taken into account when calculating bolus advice for meals up to the snack size, an increase in the blood glucose result above the target range is not tolerated after eating a snack. The shape of the meal rise (the width of the green area) is determined by the offset time and the acting time. man_07866364001_A_en.indb 331 Current BG values Allowed BG value: Meal rise Meal Bolus 1 Hyperglycaemia (hyper) 2 Above target range 3 Within target range 4 Below target range 5 Hypoglycaemia (hypo) 6 Acting time 7 Offset time 8 Target range 9 Meal rise 9 8 Time 331 28.07.2017 12:18:10 Appendix 332 man_07866364001_A_en.indb 332 28.07.2017 12:18:10 19 Glossary 19 Term Acting time Active insulin Alarm clock Automatic off Basal rate Basal rate profile BG threshold Definition The period of time from the start of bolus delivery until the point in time when the blood glucose level is expected to return to the target range. A calculated value representing the amount of insulin currently in the body that was delivered to lower the blood glucose level. This value does not include any insulin amounts that were delivered to compensate for carbohydrate intake. Audible or vibrating (silent) notification indicating a reminder. The automatic off feature stops insulin delivery if you have not touched any keys on the micropump or not established a Bluetooth wireless connection to the pump for the selected number of hours. 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 team and can be adjusted to meet your individual physiological needs that can change as the day progresses. The Accu-Chek Solo micropump offers you up to 5 different basal rate profiles in order to easily adjust insulin delivery to meet your changing insulin needs (for example, during the week compared to at the weekend). A basal rate profile consists of up to 24 basal rates. The lower and upper BG thresholds define the target range. The upper BG threshold can be used for test reminders after a high blood glucose result. The lower BG threshold can be used for test reminders after a low blood glucose result. Blood glucose (BG) The blood glucose level man_07866364001_A_en.indb 333 333 28.07.2017 12:18:10 Glossary Term Blood glucose result Bluetooth wireless technology Bolus Bolus advice Bolus advice options Broteinheit (Bread Equivalent)

(BE) Carbohydrate Choice (CC) Definition Result of a blood glucose test. Wireless transfer technology that digital devices use to exchange data. The insulin amount required to cover the intake of food and correct an elevated blood glucose level. The bolus amount is determined by your healthcare teams guidelines, your blood glucose level, your eating behaviour and your physical activity. When enabled, bolus advice provides the user with suggestions as to how much insulin should be delivered for a meal and/or to correct the blood glucose level. Factors that influence bolus advice calculation, including meal rise, snack size, acting time and offset time. One of the 4 units for the carbohydrate amount that you can select when setting up the micropump system. 1 BE = 12 grams of carbohydrates One of the 4 units for the carbohydrate amount that you can select when setting up the micropump system. 1 CC = 15 grams of carbohydrates Carbohydrate ratio Insulin amount required to compensate for a certain amount of carbohydrates. Carbohydrate unit (KE) Carbohydrates One of the 4 units for the carbohydrate amount that you can select when setting up the micropump system. 1 KE = 10 grams of carbohydrates Carbohydrates are nutrients that are broken down into sugar during digestion and increase blood glucose. Carbohydrates are generally counted to calculate a bolus insulin dose. 334 man_07866364001_A_en.indb 334 28.07.2017 12:18:10 19 Term Definition Control result Control test Current time The value displayed on the diabetes manager after a control test. If the control result is within the range shown on the label of the test strip container, the test strips and the meter unit of the diabetes manager are working properly. A meter test using control solution that lets you know whether the meter unit of the diabetes manager and the test strips are working properly. The time you set via the Settings menu on the Date and time display. Delivery lag time Period of time before delivery of a programmed bolus begins. End time Error Extended bolus Time at which a time block ends. An error message indicates that the micropump system is not working properly at the moment. After the micropump has issued an error message, it switches to Stop mode. A bolus delivered over a certain period of time. This can be helpful during long meals or for meals that are digested slowly. Factory settings The initial settings on the micropump system before you change or customise them. Flight mode Gram Setting that deactivates all wireless communication of the micropump system. Turn on flight mode when you are in an aeroplane or in other situations where radio connections are not allowed or not desirable. Exchanging data between the diabetes manager and the micropump is not possible in flight mode. One of the 4 units for the carbohydrate amount that you can select when setting up the micropump system. man_07866364001_A_en.indb 335 335 28.07.2017 12:18:10 Glossary Term Health event HI Hyper Hypo Immediate amount Infusion site Insulin Insulin analogue Insulin increment Definition Information on your current state of health or your activities. Each state of health or activity (health 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. Appears on the screen when the test result is above the diabetes managers measurement range. HI stands for high. Hyperglycaemia Hypoglycaemia Insulin amount that is delivered at the beginning of a multiwave bolus and corresponds to a standard bolus. Site at which the cannula is inserted into the subcutaneous tissue for insulin delivery. Insulin is a hormone that is necessary to process glucose. Insulin is produced in the beta cells of the pancreas. Insulin type whose chemical structure was changed specifically. Some insulin analogues act more quickly than regular insulin. The amount in units (U) by which your insulin dose is adjusted when programming a bolus or when making a manual logbook entry. Insulin sensitivity Insulin amount required to lower the blood glucose level by a certain value. LO 336 Appears on the meter when the test result is below the meters measurement range. LO stands for low. man_07866364001_A_en.indb 336 28.07.2017 12:18:10 19 Term Maintenance Meal rise Multiwave bolus Occlusion Offset time Paired Definition Maintenance messages are issued when the micropump system requires you to take action to maintain or restore its functionality. Increase in the blood glucose level during or after a meal that is considered normal, even if a bolus was delivered. Bolus that 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 specified period of time. An occlusion prevents the insulin from flowing correctly from the micropump into your body. The amount of time before the insulin starts to lower your blood glucose level. The diabetes manager and the micropump communicate with each other and transfer information to each other when they are paired. Pen/syringe bolus A bolus delivered using an insulin pen or syringe. Quick bolus Bolus that is programmed and delivered using the quick bolus buttons on the micropump. Regular insulin Reminder Settings Insulin that has the same chemical structure as insulin produced by the human pancreas. Regular insulin usually needs 30 to 45 minutes to take effect. When this feature is enabled, the meter reminds you to test your blood glucose, to retest your blood glucose, or of an event, a task or a planned activity. Settings are individually adjustable values and parameters that define the way the micropump system works. man_07866364001_A_en.indb 337 337 28.07.2017 12:18:10 Glossary Term Snack size Snooze Definition A small amount of carbohydrates (maximum 24g) that is to be compensated for by delivering a bolus, but for which no significant meal rise is expected. After a snack, a correction bolus is suggested for each blood glucose value that exceeds the target range or the maximum blood glucose value currently permitted. Reschedules a reminder or message to reoccur after a preset period of time (for example, after 15 minutes). Standard bolus Bolus for which the micropump delivers the insulin as quickly as possible. Standard deviation (SD) In this Users Manual, standard deviation indicates how the blood glucose results are scattered in relation to the BG average. If the blood glucose results are close to the BG average, the standard deviation is small. Start time The start time of a time block. Stop mode Target range Temporary Basal Rate (TBR) Time block 338 When your micropump is in Stop mode, it does not deliver any insulin. Insulin delivery is only stopped if you switch to Stop mode, change the basal rate profile, make settings using a PC or when certain error or maintenance messages are issued. Ongoing boluses or Temporary Basal Rates are interrupted when the micropump switches to Stop mode. The upper and lower BG thresholds considered acceptable when fasting or before a meal, as set by your healthcare professional. Temporary increase or decrease in your basal rate profile to match changing insulin needs due to increased or decreased activity level, illness or stress. Time blocks help you to set the target range and parameters for bolus advice for certain times of day. Up to 8 time blocks can be specified. man_07866364001_A_en.indb 338 28.07.2017 12:18:10 19 Term Definition Time of test Total daily dose U100 Unit (U) Warning Warning limit 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 the test results for a specific time of test. The total amount of insulin (basal rate plus boluses) delivered in a 24-hour period, beginning at midnight. U100 indicates the insulin concentration. Each millilitre of liquid contains 100 units of insulin International Unit (IU); unit of measurement for insulin Describes situations that require your attention and indicate a potentially dangerous situation. The micropump system issues a warning shortly before your intervention will be required. A limit value set in the diabetes manager. When your blood glucose result is above or below the hyper or hypo warning limit, a warning is displayed. You should set the hyper and hypo warning limits together with your healthcare professional. man_07866364001_A_en.indb 339 339 28.07.2017 12:18:10 Glossary 340 man_07866364001_A_en.indb 340 28.07.2017 12:18:10 20 Index man_07866364001_A_en.indb 341 20 341 28.07.2017 12:18:10 Index 342 man_07866364001_A_en.indb 342 28.07.2017 12:18:10 20 343 28.07.2017 12:18:10 man_07866364001_A_en.indb 343 Index 344 man_07866364001_A_en.indb 344 28.07.2017 12:18:10 20 345 28.07.2017 12:18:10 man_07866364001_A_en.indb 345 Index 346 man_07866364001_A_en.indb 346 28.07.2017 12:18:10

18 Appendix 18.1 Guarantee The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. Any changes or modifications to the micropump system not expressly approved by Roche could render your operating guarantee for the Accu-Chek Solo micropump system invalid. 18.2 Licence Information Licence agreement for open source software:

This product contains open source software components. For more information on open source software, see the System information item in the Settings menu of the diabetes manager. 18.3 Radio Frequency Communication This device complies with Part15 of the FCC Rules and with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions:

1. this device may not cause harmful interference, and 2. this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications made to this equipment not expressly approved by Roche Diabetes Care may void the FCC authorization to operate this equipment. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes:

1. l'appareil ne doit pas produire de brouillage, et 2. l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. 18 327 Appendix 18.4 Connecting Non-System Devices Additional equipment connected to the diabetes manager must demonstrably comply with the relevant IEC or ISO standards (e.g. IEC60950 or IEC62368 for data processing equipment). Moreover, all configurations must comply with the normative requirements for medical systems (see section16 of the latest edition of IEC60601-1). Anyone who connects additional equipment to medical electrical equipment is deemed to be the system configurer, and is therefore responsible for ensuring that the system complies with the normative requirements for systems. If you have any questions, please contact your local authorised dealer or technical customer support. 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. Contact details for the responsible Customer Support and Service Centre are provided below. Do not attempt to repair or modify the components of the micropump system yourself. Our staff will help solve any problems you might be experiencing with the micropump system from Roche. 328 Supplies and Accessories 18 18.6 Supplies and Accessories For information on the availability of additional Accu-Chek products and accessories in your country, contact the responsible customer support and service centre. wWARNING j Use only the supplied charger and the associated USB cable, or a certified USB charger (e.g. a laptop certified according to IEC60950 or an equivalent safety standard). j Use only the rechargeable battery from Roche. j Use only supplies and accessories from Roche and do Supplies for the micropump system j Accu-Chek Solo reservoir assembly j Accu-Chek Solo cannula assembly and micropump holder j Accu-Chek Solo pump base j Accu-Chek Solo insertion device Supplies for the blood glucose test j Accu-Chek Aviva test strips j Accu-Chek Aviva control solutions j Accu-Chek FastClix finger pricker j Accu-Chek FastClix lancet drums not modify them. Otherwise, you risk malfunctions of the micropump system, incorrect test results and over- or under-delivery of insulin. Accessories j Charging cradle for the diabetes manager j Carry case/fanny pack for the diabetes manager (Accu-Chek carry case) j Rechargeable battery for the diabetes manager j Battery door for the diabetes manager j Charger for the diabetes manager j USB cable If you need to replace defective system components or need another Users Manual for the micropump system, contact your Customer Support and Service Centre. 329 Appendix 18.7 Disposing of the Micropump System wWARNING All objects which can come into contact with human bodily fluids carry a potential risk of infection. There is a risk that the objects may transmit infections. Dispose of used micropump system components because using them more than once may result in infections being transmitted. Since your 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 the diabetes manager Dispose of the battery correctly and recycle it according to local regulations. 330 Bolus Calculation 18 18.8 Bolus Calculation The bolus advice feature calculates your insulin doses based on different pieces of information. Examples:

j Your current blood glucose result j Your current blood glucose target value j Your current insulin sensitivity j Your estimated carbohydrate amount for a meal j Your current carbohydrate ratio j Your current health events j Correction insulin that is still acting in the body j Your bolus and/or meal history Consider the following information when calculating bolus advice:

j How you are currently feeling: It may happen that the values entered when setting up bolus advice do not match how you are currently feeling. Increase or decrease the suggested bolus amount according to your current needs. j Bolus amounts and meals that were delivered or consumed, but not entered in the diabetes manager. j If you have delivered a bolus without using bolus advice, you can manually enter the bolus information in the electronic logbook. It is important that you enter bolus and carbohydrate information in the logbook in order to obtain accurate bolus advice recommendations. 18.8.1 Correction Bolus If your current blood glucose level does not match your blood glucose target value, a correction bolus is suggested. The correction bolus calculation is based on your current blood glucose result and your insulin sensitivity in the current time block. Your insulin sensitivity is stated in insulin units per drop in blood glucose, e.g. 1U : 40mg/dL. Calculation:

(Current BG - target BG) x insulin sensitivity Example Current BG: 149mg/dL Target BG: 110mg/dL Insulin sensitivity: 1U : 30 mg/dL Correction bolus = (149mg/dL - 110mg/dL) x (1U : 30mg/dL)

= 1.3U 331 Appendix 18.8.2 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. The carbohydrate ratio is specified in insulin units per carbohydrate amount, for example, 1U : 12 g. Calculation:

Meal bolus = carbohydrate amount x carbohydrate ratio Example Carbohydrate amount: 63 g carbohydrate ratio: 1U : 12 g Meal bolus = 63g x (1U : 12g) = 5.25U 18.8.3 Correction Bolus After a Meal After a meal, it is normal for your blood glucose level to increase even if you delivered the correct meal bolus. The allowed increase in the blood glucose level is called meal rise. After a certain period of time, the so-called offset time, the meal rise decreases slowly. The period of time from the start of the meal rise until it goes away is defined as the acting time. During this time, a correction bolus is only recommended if the increase in your blood glucose level exceeds the allowed meal rise value. 332 Chart The dotted line in the adjacent graph shows how your blood glucose level might change after a meal bolus. Bolus advice tolerates an increase in your blood glucose level within the allowed meal rise range (green). If your blood glucose result is within the green range, a correction bolus will not be recommended. If your blood glucose result is above the green range, a correction bolus will be recommended. If you enter a carbohydrate amount that is greater than the snack size, the meal rise is added to the current target blood glucose value. Since the meal rise is not taken into account when calculating bolus advice for meals up to the snack size, an increase in the blood glucose result above the target range is not tolerated after eating a snack. The shape of the meal rise (the width of the green area) is determined by the offset time and the acting time. BG 1 2 3 Bolus Calculation 18 4 5 7 6 Time Current BG values Allowed BG value: Meal rise Meal Bolus 1 Above target range 2 Within target range 3 Below target range 4 Acting time 5 Offset time 6 Target range 7 Meal rise 333 Appendix 18.8.4 Subsequent Correction Bolus A delivered correction bolus covers the difference between your current blood glucose level and your blood glucose target value for a certain amount of time. When the correction bolus begins to act, your current blood glucose level should drop; after the delay, the difference between your current blood glucose level and your blood glucose target value will diminish. At the end of the acting time, your blood glucose level should have reached the target limit value again. You will only receive a recommendation for an additional correction bolus if your current blood glucose result is higher than the blood glucose value currently permitted. Chart 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 is below the blood glucose value currently permitted (upper edge of the blue area), no additional correction bolus will be calculated. 334 7 6 Time 4 5 BG 1 2 3 Current BG values Allowed BG value: Corrected BG Bolus No bolus required 1 Above target range 2 Within target range 3 Below target range 4 Acting time 5 Offset time 6 Target range 7 Corrected BG