Roche Diagnostics Diabetes Care GW Accu-Chek Solo micropump User Manual Part 5
Roche Diagnostics GmbH Diabetes Care Accu-Chek Solo micropump Part 5
Contents
User manual Part 5
Reminders 12.2.4 Reminder: Blood Glucose Test After Meal Tap the Status switch so that it is in the ON position. Tap Time, Tone or Frequency to make the desired settings. 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. Once you have made all settings, tap Done. 246 man_07866364001_A_en.indb 246 28.07.2017 12:17:47 Types of Reminders 12 12.2.5 Reminder: Test After Low BG 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. Use and to set the lower BG threshold that should be used to remind you to test your blood glucose again. Use and to set the hours and minutes for the time span after which you want to test your blood glucose again. Tap Save. Tap Save. Once you have made all settings, tap Done. 247 man_07866364001_A_en.indb 247 28.07.2017 12:17:48 Reminders 12.2.6 Reminder: Test After High BG 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. Use and to set the upper BG threshold that should be used to remind you to test your blood glucose again. Use and to set the hours and minutes for the time span after which you want to test your blood glucose again. Tap Save. Tap Save. Once you have made all settings, tap Done. 248 man_07866364001_A_en.indb 248 28.07.2017 12:17:48 Types of Reminders 12 12.2.7 Reminder: Missed Bolus This reminder occurs if no bolus was delivered within 2 hours prior to the programmed time. You can program up to 5 reminders of the Missed bolus type. 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. 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. Once you have made all settings, tap Done. 249 man_07866364001_A_en.indb 249 28.07.2017 12:17:49 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. 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 Deleting Reminders 12 12.3 Deleting Reminders Tap the reminder you want to delete, for example, Customised 1. Tap the symbol to delete the reminder. Tap Yes if you want to permanently delete the reminder now. 251 man_07866364001_A_en.indb 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 13 Injection Therapy Mode 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. When you switch to injection therapy, your diabetes manager supports you as follows: jj Bolus advice results are rounded to the increment of your pen. jj You can note down your basal injections in the detailed test result and in the logbook entries of the diabetes manager. jj A reminder is available that you can use to be reminded about basal insulin injections. w WARNING Discuss pausing your pump therapy with your healthcare team. Switch to alternative therapies only after consultation. Note jj 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. jj Manually enter all occasional insulin amounts delivered (without bolus advice) in the electronic logbook of the diabetes manager. jj Ensure suitable storage conditions for the pump when micropump usage is temporarily discontinued. 253 man_07866364001_A_en.indb 253 28.07.2017 12:17:50 Injection Therapy Mode 13.1 Removing the Micropump Temporarily Removing the micropump 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. 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. 254 man_07866364001_A_en.indb 254 28.07.2017 12:17:51 Removing the Micropump Temporarily 13 Replacing the protective caps 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. 255 man_07866364001_A_en.indb 255 28.07.2017 12:17:51 Injection Therapy Mode 13.1.1 Activating Injection Therapy Mode 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 Note While in injection mode, the insulin amount for bolus advice is rounded for the pen according to the set insulin increment. 13 Use and to set the maximum bolus amount you want to deliver with the pen/ syringe. The display informs you that injection therapy mode is turned on. The current bolus settings are displayed. Tap Save. Tap OK if you want to continue using these settings. 257 man_07866364001_A_en.indb 257 28.07.2017 12:17:52 Injection Therapy Mode 13.1.2 Deactivating Injection Therapy Mode 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 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. 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. 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. 259 man_07866364001_A_en.indb 259 28.07.2017 12:17:53 Injection Therapy Mode Display elements omitted on the Status screen Status screen in pump therapy mode. Display element Status screen in injection therapy mode. Status screen for injection therapy Reservoir symbol is omitted Basal rate information omitted Symbols omitted in the Main menu Main menu in pump therapy mode. Menu icon Main menu in injection therapy mode. Main menu for injection therapy Start and Stop menu is omitted Basal rate menu is omitted Replace menu is omitted Ongoing bolus information omitted 260 man_07866364001_A_en.indb 260 Flight mode menu is omitted 28.07.2017 12:17:53 Injection Therapy Displays Test result in detail Test result in detail display in pump therapy mode. 13 Bolus Test result in detail display in injection therapy mode. You will also see the entry field for basal insulin. Bolus display in pump therapy mode. Bolus display in injection therapy mode. The Cancel bolus element is omitted. You cannot create any customised boluses. 261 man_07866364001_A_en.indb 261 28.07.2017 12:17:54 Injection Therapy Mode Reminders Reminders display in pump therapy mode. Warning limits Reminders display in injection therapy mode. Instead of the Replace infusion assembly reminder, the Inject basal insulin reminder appears. Warning limits display in pump therapy mode. Warning limits display in injection therapy mode. 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 Injection Therapy Displays My data Logbook entries display in pump therapy mode. 13 Bolus advice Logbook entries display in injection therapy mode. You can enter or change the amount of basal insulin delivered in the Basal insulin entry. Bolus advice display in pump therapy mode. Bolus advice display in injection therapy mode. The Type entry provides only the Pen option. 263 man_07866364001_A_en.indb 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 Injection Therapy Settings 13 13.3 Injection Therapy Settings In the Main menu, tap the Settings menu. Tap the Bolus settings entry. Tap Maximum pen bolus. Use and to set the maximum bolus amount you want to deliver with the pen/ syringe. Tap Save. 265 man_07866364001_A_en.indb 265 28.07.2017 12:17:55 Injection Therapy Mode 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 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. 14.1 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. w WARNING 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. 267 man_07866364001_A_en.indb 267 28.07.2017 12:17:55 Care and Maintenance 14.1.1 Cleaning the Diabetes Manager Note jj Avoid liquid or moisture entering the openings in the diabetes manager. jj Do not spray a cleaning solution directly onto the diabetes manager or micropump. jj Do not immerse the diabetes manager or micropump in liquids. 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 Cleaning the Micropump System Cleaning the casing Cleaning the screen Remove any large contaminants with a clean cloth. Wipe the screen of the diabetes manager carefully with a soft and slightly dampened cloth. 14 a) b) a) Turn off the diabetes manager. b) Close the cover of the USB socket. 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. Remove any remaining lint. Dry the wiped areas thoroughly. 269 man_07866364001_A_en.indb 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. 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 Note Cleaning the ventilation opening is important for the zinc-air battery in the reservoir to work properly. 14 Replace the used reservoir with a new one (see the chapter Replacing System Components). 271 man_07866364001_A_en.indb 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 jj you open a new test strip box. jj you have left the test strip container open. jj you think the test strips might be damaged. jj the test strips were exposed to extreme temperatures or humidity. jj you want to check the diabetes manager and test strips. jj the diabetes manager has fallen on the floor. jj your test result does not match how you feel. jj 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. jj Close the control solution bottle tightly after use. jj 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. jj Do not use control solution that is past the use by date. jj 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 Control Tests 14 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: jj Diabetes manager jj Accu-Chek Aviva test strips jj Accu-Chek Aviva control solution Control 1 or Control 2 jj A clean, dry paper towel Note jj 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. jj If a test strip error occurs, remove and dispose of the test strip, and repeat the test with a new test strip. jj 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. jj Another way to start a control test is from the Main menu. In the Main menu, tap the Test menu. jj Do not apply control solution to the test strip before you have inserted the test strip into the test strip slot. 273 man_07866364001_A_en.indb 273 28.07.2017 12:17:58 Care and Maintenance 14.2.3 Performing a Control Test Check the use by date that is indicated on the test strip container next to the e symbol. Use only test strips that are not past the use by date. 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 Control Tests 14 Applying a drop 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. 275 man_07866364001_A_en.indb 275 28.07.2017 12:18:03 Care and Maintenance Displaying the control result 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, Control 1). Note If you choose No entry, the control test display shown in the next step will not appear. The control result will not be analysed. Continue with Step 12. 10 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 Control Tests 14 Disposing of test strips 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. 11 12 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. 277 man_07866364001_A_en.indb 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 User’s 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? 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 apply a hanging drop of control solution? Did you apply only one drop of control solution? 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 Control Tests 14 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. 279 man_07866364001_A_en.indb 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. In the Main menu, tap the Settings menu. Tap General settings. If the diabetes manager does not work as described in the explanations of the system function test, contact your Customer Support and Service Centre. w WARNING The system must be working perfectly for all system messages (warnings and information, maintenance and error messages) to be issued correctly. 280 man_07866364001_A_en.indb 280 28.07.2017 12:18:04 Checking the System Functions 14 Checking the screen Tap Check system functions. Tap Screen. The screen shows a sequence of colours (red, blue, green and white) in quick succession. 281 man_07866364001_A_en.indb 281 28.07.2017 12:18:05 Care and Maintenance Diabetes manager signals Diabetes manager vibration Micropump signals Tap Diabetes manager signals. Tap Diabetes manager vibration. Tap Micropump signals. The diabetes manager emits signals. Note If you are using injection therapy mode, the Micropump signals entry will be deactivated and greyed out. The micropump emits signals. The diabetes manager vibrates. 282 man_07866364001_A_en.indb 282 28.07.2017 12:18:05 15 15 Messages and Troubleshooting 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: jj information messages jj warnings jj maintenance messages jj 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. 283 man_07866364001_A_en.indb 283 28.07.2017 12:18:05 Messages and Troubleshooting w WARNING 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 Information Messages 15.1 Information Messages 15 Examples of information messages: 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. 23 Information on the micropump Information on the diabetes manager Title of information message Information message symbol Information or explanation Buttons (OK, No, Yes) 285 man_07866364001_A_en.indb 285 28.07.2017 12:18:05 Messages and Troubleshooting 15.2 Warning Messages Examples of warnings: 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. 1 2 3 4 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. 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 Warning Messages Code Title of warning Information/possible cause Information/possible solution W-25 Running time of the pump will end soon The period of use of the pump base will end soon. Ensure that you have a new pump base at hand as a replacement. Replace the pump base after the remaining time that is displayed. W-31 Low level of insulin in the reservoir There is only a small amount of insulin in the reservoir. Be prepared to replace the reservoir soon. W-32 Battery almost empty The battery level is low. Replace the reservoir. W-35 Limited battery power The 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. Ensure that there is an unrestricted air supply to the reservoir and pump base. W-36 TBR cancelled An active Temporary Basal Rate was cancelled. Program a new Temporary Basal Rate. 15 Warnings triggered by the micropump 287 man_07866364001_A_en.indb 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 The micropump cannot deliver the insulin amount that is programmed for the basal rate or bolus in the specified time. 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. W-38 Bolus cancelled An active bolus was cancelled. W-40 Replace reservoir The operating life of the reservoir will soon come to an end. Replace your reservoir in the near future. Micropump stopped The micropump has been in Stop mode for at least an hour and is not delivering any insulin. Start the micropump if you want to continue with insulin delivery. The rechargeable battery level is low. Recharge the battery of your diabetes manager. W-41 Warnings triggered by the diabetes manager W-50 Battery almost empty 288 man_07866364001_A_en.indb 288 28.07.2017 12:18:06 Warning Messages Code Title of warning Information/possible cause W-71 Connection interrupted Ensure that the micropump and diabetes No current data from the micropump is manager are no more than 2 metres available. The data for calculating apart and that there are no obstacles bolus advice may not be up to date. between them. W-73 No connection to the micropump No current data from the micropump is The data is updated when the connection available. The displayed data may not between the diabetes manager and the be complete. micropump is re-established. W-75 Warning limit exceeded 15 Information/possible solution High blood glucose value Test ketones and your blood glucose. Check insulin delivery. Follow the instructions of your healthcare professional. W-76 “HI” display Your blood glucose is very high. Test your blood glucose again and test ketones. Follow the instructions of your healthcare professional. W-80 Hypoglycaemia Blood glucose has fallen below the hypo warning limit. Eat or drink fast acting carbohydrates. Then test your blood glucose. 289 man_07866364001_A_en.indb 289 28.07.2017 12:18:06 Messages and Troubleshooting Code Information/possible cause Information/possible solution “LO” display Your blood glucose result may be very low. W-82 Bluetooth connection deactivated The Bluetooth connection to the micropump was deactivated because the rechargeable battery of the diabetes manager is almost empty. 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. W-84 Testing not possible You cannot test your blood glucose while the diabetes manager is connected to a USB cable. Missing data Internal clock error or error in existing bolus data. The saved data can no longer be used to calculate bolus advice. W-81 W-85 Title of warning 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 Warning Messages Code W-86 W-88 Title of warning Information/possible cause Information/possible solution 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. 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. Flight mode on The saved logbook entries may not be up to date. When flight mode is turned off and the diabetes manager and micropump are within communication range, the logbook entries will be synchronised. 15 291 man_07866364001_A_en.indb 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 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. 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. W-90 Time synchronised with micropump A time difference between the diabetes manager and the micropump was Check the time on the diabetes manager. corrected. TBR without insulin delivery 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. W-92 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 Code W-93 W-99 Title of warning Information/possible cause Information/possible solution Fill reservoir needle The micropump must NOT have been inserted in the micropump holder. 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. No connection to the micropump 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 diabetes manager can currently only give bolus advice based on the entries saved in the diabetes manager. 15 293 man_07866364001_A_en.indb 293 28.07.2017 12:18:06 Messages and Troubleshooting 15.3 Maintenance Messages Examples of 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. 1 2 3 4 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. 294 man_07866364001_A_en.indb 294 Code of maintenance message Maintenance activity refers to the micropump Maintenance activity refers to the diabetes manager Title of maintenance message Explanation of maintenance message or corrective measure Button to confirm (OK) or postpone the maintenance message (Snooze) “Maintenance” symbol 28.07.2017 12:18:06 Maintenance Messages Code Title of maintenance message Possible cause/consequences 15 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 The entered insulin amount does not correspond to the measured reservoir level. Replace the reservoir, if required, with a new reservoir. M-21 Reservoir empty The insulin in the reservoir has been used up. Select the Replace menu and replace the reservoir 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 The automatic off feature has stopped insulin delivery. The micropump is in Stop mode. Start the micropump to resume insulin delivery. Occlusion An occlusion was detected which means that insulin delivery is not working at all or is restricted. 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. M-24 295 man_07866364001_A_en.indb 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. Remove the micropump from the infusion assembly. Tap the Replace menu, select Reservoir and follow the instructions for filling the reservoir. The micropump system setup was interrupted. 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. M-27 No data connection Maintenance messages triggered by the diabetes manager M-51 Test strip error The test strip is used, damaged or not completely inserted into the test strip slot. Use a new test strip or re-insert the test strip into the test strip slot. M-53 Test failed The blood glucose test did not work properly. Repeat the blood glucose test with a new test strip. M-54 Drop too small Repeat the test with a new test strip. Make sure The amount of blood or control solution the blood drop or drop of control solution is large is not sufficient to perform a test. enough. 296 man_07866364001_A_en.indb 296 28.07.2017 12:18:06 Maintenance Messages Code Title of maintenance message Possible cause/consequences Further information M-56 Drop applied too early The drop was drawn into the test strip before Apply drop appeared on the screen. Repeat the test with a new test strip and a fresh blood drop or drop of control solution. M-58 Temperature too high or too low The ambient temperature for testing blood glucose or performing a control test is outside the permitted range. Make sure the ambient temperature is within the permitted range. Wait 5 minutes before testing your blood glucose again or performing a control test. M-59 Battery almost empty The rechargeable battery level is very low. Recharge the battery of your diabetes manager. M-60 Clock error A discrepancy in the micropump’s internal clocks was detected. Set the current time and the current date on the diabetes manager. 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. M-62 15 297 man_07866364001_A_en.indb 297 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of maintenance message Possible cause/consequences Further information M-64 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. M-65 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 There is no connection to the micropump. Hold the diabetes manager close to the micropump. You can deliver a quick bolus straight from the micropump. M-77 Operation failed The requested operation failed. Try again. M-78 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. M-84 Temperature is at limit of range The ambient temperature is at the edge of the range permitted for blood glucose tests. Ensure the ambient temperature is within the permitted range before you test your blood glucose. M-85 Micropump incompatible You tried to pair the diabetes manager with a micropump base that is incompatible. Contact your Customer Support and Service Centre. 298 man_07866364001_A_en.indb 298 28.07.2017 12:18:06 Maintenance Messages 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. 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. M-87 Micropump not stopped The micropump cannot be stopped. Code Try to stop the micropump again. Remove the micropump from the pump base if you want to interrupt insulin delivery. Flight mode turned off The micropump and the diabetes manager are not within communication Hold the diabetes manager close to the micropump. range. Flight mode could not be turned on on the micropump. M-94 Connection failed There is a communication problem between the micropump and the diabetes manager. Hold the diabetes manager close to the micropump and ensure that data communication is not disrupted. Check the micropump. M-95 No micropump located A connection to the micropump could not be established. Check whether the micropump is too far away. M-88 15 299 man_07866364001_A_en.indb 299 28.07.2017 12:18:06 Messages and Troubleshooting Code Title of maintenance message Possible cause/consequences Further information M-96 USB connection failed 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 Error Messages 15.4 Error Messages 15 Examples of error messages: 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. 1 2 34 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. Code of error message Error refers to the micropump Error refers to the diabetes manager Title of error message Button to confirm (OK) or postpone the error message (Snooze) “Error” symbol Explanation of error message 301 man_07866364001_A_en.indb 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 E-7 E-8 Mechanical error in the micropump The micropump switches to Stop Select the Replace menu and replace the mode and does not deliver any insulin. micropump and the reservoir. Electronic error Communication between the micropump and diabetes manager is not possible. The micropump does not deliver any insulin. Micropump battery error The energy supply is defective. The micropump switches to Stop Select the Replace menu and replace the mode and does not deliver any insulin. reservoir with a new one. After 10 seconds the pump turns off. Select the Replace menu and replace the micropump and the reservoir. Error messages triggered by the diabetes manager E-57 Electronic error Remove the rechargeable battery from the The electronic components of the diabetes manager and reinsert it. diabetes manager are not behaving as If the error message is displayed again, contact expected. your Customer Support and Service Centre. E-60 Internal clock error Internal clock error in the diabetes manager Contact your Customer Support and Service Centre. 302 man_07866364001_A_en.indb 302 28.07.2017 12:18:07 Troubleshooting 15 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. 303 man_07866364001_A_en.indb 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 Charge the battery. For more information, see the chapter Setting Up the low. 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. Reset the diabetes manager by pressing and holding the power button for at least 5 seconds. The ambient temperature is higher or lower than the Move the diabetes manager to an area with the suitable temperature. operating temperature Wait 5 minutes before turning on the diabetes manager. Do not heat or recommended for the cool the diabetes manager using any aids. diabetes manager. The battery is not being charged while the diabetes manager is connected to a PC via a USB cable. The screen is damaged or the diabetes manager is defective. Contact your Customer Support and Service Centre. The USB port on the PC is not supplying any charging current. Recharge the battery with a charger using a wall socket. 304 man_07866364001_A_en.indb 304 28.07.2017 12:18:07 Troubleshooting Problem Possible cause The battery must be charged more often than at the beginning. The number of charge cycles for the rechargeable battery is limited. If this number is exceeded, the Replace the battery. charge capacity is reduced and the battery must be recharged more frequently. The screen freezes or does not respond. An electronic error has occurred in the diabetes manager. The screen is defective or the colours are not represented correctly. 15 Possible solutions jj Reset the diabetes manager by pressing and holding the power button for at least 5 seconds until the screen turns off. jj 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 User’s Manual. If the system function test of the screen shows a problem, contact your Customer Support and Service Centre. 305 man_07866364001_A_en.indb 305 28.07.2017 12:18:07 Messages and Troubleshooting Problem Possible cause Possible solutions The sound is faulty. You cannot hear the signals. jj 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 User’s Manual. jj 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 The sound feature is turned more information, see the section Turning Off Signals in the chapter off or the volume is set too Changing Settings of this User’s Manual. low. jj 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 User’s 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. 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. 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. 306 man_07866364001_A_en.indb 306 28.07.2017 12:18:07 Troubleshooting Problem Possible cause Possible solutions You cannot feel any vibrations when a signal is emitted. The vibration feature is turned off. 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). The occlusion alarm of the micropump was triggered. The micropump was exposed to a temperature that was too low. Make sure the ambient temperature is suitable. Perform the recommended maintenance measure (see maintenance message M-24) and continue the therapy. 15 307 man_07866364001_A_en.indb 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 Electromagnetic compatibility Safety Rapid-acting U100 insulin types: Humalog®, NovoLog/NovoRapid®, Apidra®, Insuman® Infusat The micropump system meets the EMC requirements for home healthcare environments. Classified in accordance with CISPR 11, group 1, class B (residential). 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. 309 man_07866364001_A_en.indb 309 28.07.2017 12:18:07 Technical Data 16.2 Diabetes Manager Technical data of the diabetes manager Device type Accu-Chek Aviva Solo diabetes manager, model # The Accu-Chek Aviva Solo diabetes manager is suitable for continuous operation. Access control PIN-based protection Dimensions 124 x 64 x 17 mm (L x W x H) Weight 140 g Signal reproduction Graphical user interface, status LED, loudspeaker, vibration alarm Screen Capacitive colour LCD multi-touch screen with backlight Screen size 3.5 " Screen resolution 320 x 480 pixels Video format MPEG-4 at a frame rate of 30 frames/second Audio format mp3 Screen brightness Screen orientation Portrait (standard) or landscape Screen timeout 30 sec. (screen goes dark after 15 sec., plus 15 sec. until screen times out) Camera 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. 310 man_07866364001_A_en.indb 310 28.07.2017 12:18:07 Diabetes Manager 16 Technical data of the diabetes manager Data transfer between the micropump and the diabetes manager Bluetooth Low Energy (BLE) wireless technology Transmission frequency 2402–2480 MHz Transmission power Maximum 1 mW / 0 dBm Channels: 37*FHSS + 3*DSSS advertising channels Modulation: GFSK Bandwidth: 1 MHz “single hop frequency” Communication range > 1.5 m (line of sight) Admissible temperature range During operation: +5 °C to +40 °C Storage between periods of use, without packaging: -25 °C to +70 °C Storage and transport, with packaging: -20 °C to +50 °C Admissible humidity range During operation: 15 % to 93 % Storage between periods of use, without packaging: 5 % to 93 % Storage and transport, with packaging: 5 % to 85 % Atmospheric pressure During operation: 70 to 106 kPa During charging: 80 to 106 kPa Storage between periods of use, without packaging: 54.9 to 106 kPa Storage and transport, with packaging: 54.9 to 106 kPa Operating height Up to 3,000 m above sea level Alarm types Visual, acoustic, vibration Sound pressure of the alarm signal > 45 dB (A) at a distance of 1 m man_07866364001_A_en.indb 311 311 28.07.2017 12:18:07 Technical Data Technical data of the diabetes manager Frequency 1–3 kHz Interface to PC USB 2.0 (micro-B) Memory capacity 5,000 blood glucose tests, 5,000 logbook entries, 5,000 pump events Power supply Rechargeable lithium-ion battery Battery voltage 3.7 V Battery capacity 1,530 mAh Charging voltage via USB 5V Socket adapter PHIHONG switching power supply, model PSC03R‑050 IP rating IP20 Protection class II in battery mode with internal power supply Bolus calculator Accu-Chek Bolus Advisor Blood glucose meter Accu-Chek Aviva Test strip slot Illuminated test strip slot for Accu-Chek Aviva test strips Measuring range 0.6–33.3 mmol/L (10–600 mg/dL) Test principle Refer to the test strip package insert Test time Refer to the test strip package insert Blood sample Refer to the test strip package insert Sample type Refer to the test strip package insert 312 man_07866364001_A_en.indb 312 28.07.2017 12:18:07 Micropump 16 16.3 Micropump Technical data of the micropump Dimensions Approx. 68 × 40 × 15 mm Weight Micropump without reservoir: approx. 18 g Micropump with filled reservoir and infusion assembly: approx. 32 g Pump casing Impact and scratch-resistant plastic (polycarbonate) Quick bolus buttons Silicone buttons for delivering quick boluses and turning flight mode on/off Admissible temperature range* During operation: +5 °C to +40 °C Storage between periods of use, without packaging: -25 °C to +70 °C Storage and transport, with packaging: -20 °C to +50 °C Admissible humidity range During operation: 15 % to 93 % Storage between periods of use, without packaging: 15 % to 93 % Storage and transport, with packaging: 20 % to 85 % Atmospheric pressure 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) Motor type Stepper motor Power supply 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: 23 °C ±2 °C), 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 Minimum: 0.1 U/h Maximum: 25.0 U/h Basal rate, increments 0.1 U up to under 5.0 U: increments of 0.01 units 5.0 U up to under 25.0 U: increments of 0.1 units Basal rate delivery accuracy ±15 % or better at 0.1 U to 1.0 U ±5 % or better at 1.0 U to the maximum Basal rate profiles Up to 5 customised profiles Temporary Basal Rate (TBR) 0–90 % for basal rate reductions and 110–250 % for basal rate increases in increments of 10 % The duration is adjustable in 15-minute increments for a time period of up to 24 hours. Bolus types Standard bolus, quick bolus, extended bolus, multiwave bolus Bolus amount Minimum: 0.2 U Maximum: 50 U Bolus delivery accuracy ±30 % or better at 0.2 U up to under 1.0 U ±17 % or better at 1.0 U 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 0.2 U up to under 2.0 U: increments of 0.05 units 2.0 U up to under 5.0 U: increments of 0.1 units 5.0 U up to under 10.0 U: increments of 0.2 units 10.0 U up to under 20.0 U: increments of 0.5 units 20.0 U up to 50.0 U: 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 0.2 U / 0.5 U / 1.0 U and 2.0 U Bolus delivery speed 1.0–2.5 U/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 50 hours Maximum insulin amount until message “Maintenance M24: OCCLUSION” is displayed 5.0 U Maximum limit value for the system warning in the event of an occlusion 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 150 kPa (1.5 bar) Reservoir Fillable insulin container Reservoir fill amount Maximum: 200 U Minimum: 80 U (±12 U) Maximum overdelivery in the event of an error 0.4 U 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. 68 × 40 × 1.65 mm Cannula Orange, 6 mm 90° Teflon® soft cannula Blue, 9 mm 90° Teflon® soft cannula Cannula fill amount 0.2 U Maximum period of use 72 hours Sterility Sterilized using ethylene oxide for single use according to ISO 11135-1 Protective caps Silicone caps for the reservoir and the infusion assembly 317 man_07866364001_A_en.indb 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 17 Symbols, Abbreviations, Signals 17.1 Symbols The following symbols appear on the packaging and on the components of the micropump system: Symbol Meaning Consult instructions for use Caution, refer to safety-related notes in the instructions for use accompanying this product. Symbol Meaning Sterilized using ethylene oxide Manufacturer Date of manufacture Follow instructions for use Catalogue number Temperature limitation (store at) Batch code Use only once Serial number Use by 319 man_07866364001_A_en.indb 319 28.07.2017 12:18:08 Symbols, Abbreviations, Signals 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: jj European Directive 2014/53/EU on the provision of radio equipment (RED). jj 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. Symbol Meaning 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 Symbols Symbol 17 Meaning 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 IP20 Protected against solid foreign objects with a diameter of at least 12.5 mm Protected against access with a finger IP22 Protected against solid foreign objects with a diameter of at least 12.5 mm 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 321 man_07866364001_A_en.indb 321 28.07.2017 12:18:09 Symbols, Abbreviations, Signals 17.2 Abbreviations Abbreviation Meaning Abbreviation Meaning am Ante meridiem: Before midday (12-hour clock notation for times before 12 noon) ISO International Organization for Standardization BE Broteinheit (bread equivalent) KE Kohlenhydrateinheit (carbohydrate unit) BG Blood Glucose LCD Liquid Crystal Display °C Degrees Celsius (or Centigrade) mg/dL Milligrams per decilitre CC Carbohydrate Choice mmol/L Millimoles per litre DM Diabetes manager kPa Kilopascal °F Degrees Fahrenheit PC Personal Computer FCC Federal Communications Commission (United States) PIN Personal Identification Number (secret code) pm Gram Post meridiem: After midday (12-hour clock notation for times after 12 noon) Hour (s) SD Standard Deviation IC Industry Canada (Canadian telecommunications authority) sec. Seconds TBR Temporary Basal Rate IEC International Electrotechnical Commission 322 man_07866364001_A_en.indb 322 28.07.2017 12:18:09 Abbreviations Abbreviation 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. U/h Insulin amount delivered in units per hour U100 Insulin concentration. Each millilitre of liquid contains 100 units of insulin. USB Universal Serial Bus 17 323 man_07866364001_A_en.indb 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 18 Appendix 18.1 Guarantee 18.2 Licence Information The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. 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. 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. 325 man_07866364001_A_en.indb 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 Supplies and Accessories 18 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 test results and over- or under-delivery of insulin. Supplies for the micropump system jj Accu-Chek Solo reservoir assembly jj Accu-Chek Solo cannula assembly and micropump holder jj Accu-Chek Solo micropump jj Accu-Chek Solo insertion device Supplies for the blood glucose test jj Accu-Chek Aviva test strips jj Accu-Chek Aviva control solutions jj Accu-Chek FastClix finger pricker jj Accu-Chek FastClix lancet drums Accessories jj Charging cradle for the diabetes manager jj Carry case/belt pouch (Accu-Chek carry case/Accu-Chek belt pouch) jj Rechargeable battery for the diabetes manager jj Battery door for the diabetes manager jj Charger for the diabetes manager jj USB cable If you need to replace defective system components or need another User’s Manual for the micropump system, contact your Customer Support and Service Centre. 327 man_07866364001_A_en.indb 327 28.07.2017 12:18:09 Appendix 18.5 Disposing of the Micropump System w WARNING 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
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