
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
327 18 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 Part 15 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 présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: 1. l'appareil ne doit pas produire de brouillage, et 2. l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. 18 Appendix 328 Appendix 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. 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. IEC 60950 or IEC 62368 for data processing equipment). Moreover, all configurations must comply with the normative requirements for medical systems (see section 16 of the latest edition of IEC 60601-1). 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. 329 Supplies and Accessories 18 18.6 Supplies and Accessories Supplies for the micropump system jAccu-Chek Solo reservoir assembly jAccu-Chek Solo cannula assembly and micropump holder jAccu-Chek Solo pump base jAccu-Chek Solo insertion device Supplies for the blood glucose test jAccu-Chek Aviva test strips jAccu-Chek Aviva control solutions jAccu-Chek FastClix finger pricker jAccu-Chek FastClix lancet drums Accessories jCharging cradle for the diabetes manager jCarry case/fanny pack for the diabetes manager (Accu-Chek carry case) jRechargeable battery for the diabetes manager jBattery door for the diabetes manager jCharger for the diabetes manager jUSB cable If you need to replace defective system components or need another User’s Manual for the micropump system, contact your Customer Support and Service Centre. For information on the availability of additional Accu-Chek products and accessories in your country, contact the responsible customer support and service centre. w WARNING jUse only the supplied charger and the associated USB cable, or a certified USB charger (e.g. a laptop certified according to IEC 60950 or an equivalent safety standard). jUse only the rechargeable battery from Roche. jUse only supplies and accessories from Roche and do not modify them. Otherwise, you risk malfunctions of the micropump system, incorrect test results and over- or under-delivery of insulin. 330 Appendix 18.7 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 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. 331 Bolus Calculation 18 18.8 Bolus Calculation The bolus advice feature calculates your insulin doses based on different pieces of information. Examples: jYour current blood glucose result jYour current blood glucose target value jYour current insulin sensitivity jYour estimated carbohydrate amount for a meal jYour current carbohydrate ratio jYour current health events jCorrection insulin that is still acting in the body jYour bolus and/or meal history Consider the following information when calculating bolus advice: jHow 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. jBolus amounts and meals that were delivered or consumed, but not entered in the diabetes manager. jIf 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…
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User’s Manual Accu-Chek Solo micropump system DRAFT (US) 08-MAY-2020 I am a person with diabetes being treated with insulin. The insulin is delivered to my body by a micropump. If I am confused or unconscious, please do the following: Call 911. If I am able to swallow, give me sugar immediately, for example, juice. Remove the micropump from my body. Emergency card Name Address Phone In case of emergency, please contact: Name Phone Important information You can call up important handling steps for the micropump system as a video via the Help function on the diabetes manager. If the diabetes manager does not work, recharge the battery using the supplied charger or connect the USB cable to a PC. For more information, refer to the printed User’s Manual of the micropump system or visit accu-chek.com. From this website, you can download the User’s Manual as a PDF file. You can contact the Accu-Chek Customer Care Service Center by calling 1-800-688-4578. My notes Medical certificate This is to certify that Name Date of birth has DIABETES MELLITUS. She/He relies on a regular supply of insulin from the Accu-Chek Solo micropump, which she/he wears on her/his body. Place and date Healthcare professional name Phone Fax Healthcare professional signature Stamp Delivering a bolus with the micropump Setting the quick bolus increment The quick bolus increment is set to 0.2 U by factory default. The quick bolus increment I have set is U. You can change the quick bolus increment here: Main menu > Settings > Bolus settings 1. Press and hold both quick bolus buttons for approximately 3 seconds. 2. Simultaneously press both quick bolus buttons repeatedly until the desired insulin amount is reached. Check the (number of) tones. 3. Simultaneously press both quick bolus buttons to confirm the insulin delivery. 3 s 321 0xxxxxxx001 /A0 Last update 2020-04 Data Matrix Code Approved/listed/registered under the product name: Accu-Chek Solo micropump system ACCU-CHEK, ACCU-CHEK GUIDE, ACCU-CHEK SMART PIX, and ACCU-CHEK SOLO are trademarks of Roche. The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Teflon ® is a registered trademark of E. I. du Pont de Nemours and Company or its affiliates. All other product names and trademarks are the property of their respective owners. © 2020 Roche Diabetes Care Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.accu-chek.com Last update 2020-05 Contents About this User’s Manual IV Scope of delivery VI Consumables VI 1 What is the Purpose of the Micropump System? 1 1.1 Intended Use 1 1.2 Contraindications 2 1.3 Risks and Benefits 3 1.4 General Warnings 4 1.5 Components of the Micropump System 6 1.6 Characteristics of the Micropump System 8 1.7 Using the Micropump System in Daily Life 10 2 Getting to Know the Micropump System 13 2.1 Diabetes Manager Overview 13 2.2 Status Screen 16 2.3 Main Menu 19 2.4 Information Screen 22 2.5 Navigation and Operation 23 3 Putting the DM into Operation 33 3.1 Charging the Battery 33 3.2 Setup Wizard 39 3.3 Programming a Basal Rate Profile 52 4 Putting the Micropump into Operation 57 4.1 Overview 57 4.2 Recommended Infusion Sites 61 4.3 Putting the Components into Operation 62 4.4 Stopping and Starting the Micropump 83 5 Testing or Entering Your BG Level 85 5.1 Testing Blood Glucose 85 5.2 Entering Your Blood Glucose Value 103 6 Delivering a Bolus 105 6.1 Manual Bolus Delivery 105 6.2 Bolus Input Display 106 6.3 Bolus Types 107 6.4 Programming a Bolus 109 6.5 Quick Bolus 118 6.6 Delivering a Bolus with a Pen or Syringe 121 6.7 Canceling a Bolus 123 6.8 Setting the Delivery Lag Time 127 7 Bolus Advice 129 7.1 Overview 129 7.2 Setting Up Bolus Advice 132 7.3 Changing Bolus Advice and Time Blocks 144 7.4 Using Bolus Advice 154 7.5 Turning Off Bolus Advice 166 8 Basal Rate Profiles and Temporary Basal Rates 167 8.1 Basal Rate Profiles 167 8.2 Creating and Editing a Basal Rate Profile 168 8.3 Temporary Basal Rates 176 8.4 Creating and Editing a TBR 177 9 Replacing System Components 185 9.1 Starting the Replacement of System Components 186 9.2 Replacing the Infusion Assembly 187 9.3 Replacing the Reservoir 190 9.4 Replacing the Pump Base 193 10 My Data 195 10.1 Overview 195 10.2 Logbook 195 10.3 Trend Graph 203 10.4 Standard Week 208 10.5 Target Range 211 10.6 BG Averages Table 214 10.7 System Events 216 10.8 Data Transfer 219 11 Changing Settings 221 11.1 Warning Limits 222 11.2 Time and Date 227 11.3 Bolus Settings 229 11.4 Tone and Vibration 234 11.5 Turning Off Signals Temporarily 237 11.6 General Settings 240 11.7 Screen Lock 242 11.8 System Information 245 11.9 Traveling and Flight Mode 247 12 Reminders 251 12.1 Overview of Reminders 252 12.2 Programming Reminders 253 12.3 Deleting Reminders 262 12.4 Issuing Reminders 263 13 Injection Therapy Mode 265 13.1 Removing the Micropump Temporarily 266 13.2 Injection Therapy Displays 272 14 Care and Maintenance 277 14.1 Cleaning and Disinfecting the Micropump System 277 14.2 Control Test of the Diabetes Manager 288 14.3 Checking the System Functions 295 15 Messages and Troubleshooting 298 15.1 Information 300 15.2 Warnings 301 15.3 Maintenance Messages 308 15.4 Error Messages 315 15.5 General Troubleshooting 318 16 Technical Data 324 16.1 Micropump System 324 16.2 Diabetes Manager 326 16.3 Micropump 329 16.4 Infusion Assembly 333 16.5 Insertion Device 334 16.6 Delivery Rate Accuracy 335 17 Symbols, Abbreviations, Signals 340 17.1 Symbols 340 17.2 Abbreviations 343 17.3 Signals 345 18 Appendix 348 18.1 Guarantee 348 18.2 License Information 352 18.3 Declaration of Conformity, Radio Equipment Directive 353 18.4 Connecting Non-System Devices 353 18.5 Accu-Chek Customer Care Service Center 353 18.6 Supplies and Accessories 354 18.7 Disposing of the Micropump System 355 18.8 Bolus Calculation 359 19 Glossary 368 20 Index 376 About this User’s Manual Read this User’s Manual carefully before using …
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3 35 Charging the Battery 123 Plug the larger end (USB type A) of the USB cable into the USB port of the charger. Plug the smaller end (USB type micro-B) of the USB cable into the USB port of the diabetes manager. Plug the charger into an electrical outlet. 3.1.2 Charging the Battery Using an Electrical Outlet 4 Close the battery compartment by pushing the battery door in the direction of the arrow until it clicks into place. 36 Putting the Diabetes Manager into Operation Note The blue LED lights up to indicate that the battery is being charged. If the rechargeable battery of the diabetes manager has been depleted, 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: jDisconnect the charger from the diabetes manager. jWait for a short time. jReconnect the charger to the diabetes manager. jIf the problem cannot be resolved using the suggested solutions, contact the Accu-Chek Customer Care Service Center. 4 The Status screen or Main menu displays the symbol in the status bar. It indicates that the battery is being charged. To end the charging process, first remove the USB cable from the diabetes manager, then unplug the charger from the electrical outlet. 3 37 Charging the Battery 12 Plug the smaller end (micro-B plug) of the USB cable into the USB port of the diabetes manager. Plug the larger end (USB-A plug) of the USB cable into a free USB charging port on your computer. The USB charging port is often indicated by a lightning bolt symbol . 3.1.3 Charging the Battery Using a Computer 3 The Status screen or Main menu displays the symbol in the status bar. It indicates that the battery is being charged. To end the charging process, first remove the USB cable from the diabetes manager and then from the PC. 38 Putting the Diabetes Manager into Operation Note jThe 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. jIf the battery level of the diabetes manager is very low, the screen is black at first. jIf you want to transfer data to a computer via the USB cable, follow the instructions in chapter 10.8 Data Transfer. 3 39 Setup Wizard 3.2 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 press the Back button during setup, you will be taken to the next previous resume point. All data and settings that you have made after the last resume point are deleted. w WARNING jDiscuss your individual settings for insulin dose, warning limits, time blocks and bolus advice with your healthcare professional. jWrong basal rate settings may lead to hyperglycemia or hypoglycemia. jHaving the time and date set precisely is essential in order for your micropump system to function properly. Having the wrong time set may result in the delivery of incorrect insulin amounts, thus leading to hyperglycemia or hypoglycemia. The data and settings you enter are cached at specific resume 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. Caching the setup 40 Putting the Diabetes Manager into Operation 1 Enter a PIN (secret identification number) of your choice with 4 to 8 digits. Choose a PIN that is easy to remember. Write down the PIN and keep it in a safe place. Tap OK. Entering the PIN 1 Tap the desired language. If required, scroll the list upwards to view additional languages. Tap Save. Setting the language 12 Press and hold the power button on the top of the diabetes manager until the diabetes manager turns on. If the diabetes manager is turned on: Briefly press the power button to activate the energy-saving standby mode. The diabetes manager vibrates, issues the “Start” signal sequence, and the signal LED lights up. The start display appears briefly. For more information on the sequences of signals, see chapter 17.3 Signals. Power on/Standby 3 41 Setup Wizard 2 Enter the PIN a second time to confirm. Tap OK. Note If you have forgotten the PIN you chose, you can unlock the diabetes manager with a PIN unlock code. You will find the label with the 8-digit PIN unlock code in the envelope in the bottom drawer of the micropump system packaging (system kit). Selecting Setup mode 1 Tap Manual setup and continue with the section Setting the time and date. Note It is not currently possible to perform the setup on a PC. 42 Putting the Diabetes Manager into Operation 1 2 Tap Time format.Tap the desired time format. Tap Save. Setting the time and date Times and time periods are always displayed or entered in the following format HH:MM (HH = hours, MM = minutes). 24-hour time format 01:07 16:15 HH:MM 12-hour time format 01:07 am 04:15 pm HH:MM am or pm Time period02:352 hours and 35 minutes The 12-hour time format is preset. The date is always displayed or entered in the format DD MMM YYYY (DD = day, MMM = month, YYYY = year), for example, 29 Mar 2019. 3 43 Setup Wizard 34 Tap Time. The hours field is selected (dark background). Use and to set the hours. 65 Tap Date. Tap the minutes field. Use and to set the minutes. Tap OK. 44 Putting the Diabetes Manager into Operation 789 The day field is highlighted. Use and to set the day. Tap the month field. Use and to set the month. Tap the year field. Use and to set the year. Tap OK. 10 Once you have entered all settings for time and date, tap OK. 3 45 Setup Wizard 1 Tap the carbohydrate unit you want to set. The diabetes manager offers the following carbohydrate units for selection: AbbreviationUnit of measurementGram equivalent gGram1 gram BE Broteinheit (bread equivalent) 12 grams KE Kohlenhydrateinhe…
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4 61 Recommended Infusion Sites 4.2 Recommended Infusion Sites Blue areas: Recommended infusion sites Gray areas: Possible infusion sites Choose a suitable infusion site before inserting a new infusion assembly. Consult your healthcare professional for advice. Sites with sufficient subcutaneous tissue are the most suitable. For example: Infusion siteCharacteristics Abdominal region Common infusion site with good insulin absorption. Upper arm Slower insulin absorption compared to the abdominal region. Thigh Slower insulin absorption compared to the abdominal region. Hip, lower back, buttocks Slower insulin absorption compared to the abdominal region. Also suitable for physically active users or if not much subcutaneous tissue is available. 62 Putting the Micropump into Operation 4.3 Putting the Components into Operation 2 Follow the instructions shown on the Prepare micropump display. If you want to see the action steps as an animated video, tap Help. Once you have performed all 3 steps, tap Done. 1 After setting up the diabetes manager, the Prepare micropump display appears. Tap OK. Note jThe pump holder must not be attached to sites on the body with scars, birthmarks and moles, tattoos, injuries, bruises or rashes. jBefore you attach the pump holder to the body, the infusion site must be completely dry. jA new infusion site must be at least 2 inches away from the last infusion site. jTo avoid injury and infection, never touch the introducer needle or the cannula. jIf the pump holder frequently becomes detached from the skin, consult your healthcare professional to find a method that may improve adhesion to the skin. jIf the infusion site becomes irritated, replace the infusion assembly immediately and choose a new infusion site. 4 63 Putting the Components into Operation 1 324 Wash your hands and dry them thoroughly. Remove the pump holder from the packaging. Select a suitable site on the body. Disinfect the site on your body according to the instructions given by your healthcare professional. Make sure that the infusion site is dry and free from residues. Attach the hook on the pump holder to the underside of the insertion device. Press the pump holder onto the underside of the insertion device until it locks into place. Check whether the pump holder is correctly locked into place. 4.3.1 Attaching the Infusion Assembly to the Body 64 Putting the Micropump into Operation 6 7 Insert the cannula assembly into the insertion device. Push the cannula assembly into the slot until you hear it click into place. Use the positioning aid to check whether the cannula assembly is in the correct position. 5 Prime the insertion device by rotating the priming handle clockwise in the direction of the arrow, as far as it will go. When the insertion device is fully primed, you will hear a click. 180° 8 Remove both parts of the protective film from the adhesive pad. Do not touch the adhesive surface of the adhesive pad. This could impair the adhesive properties. 4 65 Putting the Components into Operation 9 10 Holding the skin taut, press the insertion device firmly against the selected site on your body. Press the blue release button to insert the cannula under the skin. 11 Smooth over the adhesive pad around the infusion assembly so that the infusion assembly is in good contact with the skin. 12 Press the detach button and detach the insertion device from the infusion assembly. If possible, keep the adhesive pad in position with the other hand.
4 67 Putting the Components into Operation w WARNING During disposal, ensure that no third party could injure themselves and risk an infection. Note jDo not use the insertion device without first inserting the cannula assembly. Before storing the insertion device, ensure that there is no cannula assembly in the insertion device. jNever store the insertion device in a primed state. Storing the insertion device incorrectly may weaken the spring tension, which will impair the operation of the insertion device. jCheck at regular intervals whether the micropump system has visible or tangible signs of damage. This applies in particular if the system components were dropped or were exposed to particular mechanical stress. 68 Putting the Micropump into Operation 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. jUse and store the insulin in compliance with the manufacturer’s specifications and pay attention to the use by date. jMake sure that the insulin is at room temperature before using it in the micropump. Use the reservoir immediately after filling it. jOcclusions may occur if the temperature of the insulin or micropump system is too low. jDuring filling, make sure you remove any air bubbles from the reservoir. 4.3.2 Filling the Reservoir with Insulin w WARNING jOnly use the micropump to deliver rapid-acting U100 insulin. jIf 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. 4 69 Putting the Components into Operation 143 Disinfect the top of the insulin vial with a sterile alcohol wipe. Allow the disinfected top of the insulin vial to dry. Hold the round part of the handle firmly and pull it downwards in the direction of the arrow in order to fill the reservoir with air. Fill the reservoir with the volume of air that you later want to fill with insulin. Carefully pull out the battery’s protective film downwards in the direction of the arrow to activate the battery. 2 Remove the new reservoir assembly from the packaging. 70 Putting the Micropump into Operation 67 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 is above the reservoir. 5 Place the insulin vial on a flat and solid surface (for example, a table top) and hold it firmly. Place the filling aid onto the vial. Push the filling aid downwards until you hear it click into place. Note jThe reservoir must be filled with at least 80 U. jThe reservoir has a maximum holding capacity of 200 U (2.0 ml). jTake care not to touch the reservoir needle. You might injure yourself. 4 71 Putting the Components into Operation 910 To release air bubbles from the reservoir, hold the reservoir at an angle. Gently flick your finger against the reservoir several times. Slowly push the handle upwards in the direction of the arrow 1 to remove air bubbles from the reservoir. Slowly pull the handle downwards in the direction of the arrow 2 until the reservoir is filled with the required amount of insulin again. Slowly pull the handle downwards in the direction of the arrow to fill the reservoir with insulin. Try to ensure that no air bubbles form in the reservoir. 1 2 8 Note Check the reservoir from several angles to make sure that there are no air bubbles in the reservoir. 72 Putting the Micropump into Operation 11 Remove the filling aid from the reservoir by pulling it off laterally in the direction of the arrow. Contact your local waste management authority for guidance on how to recycle or dispose of the filling aid in an environmentally responsible manner. 12 Compress the handle on the ribbed surface 1 and then remove the handle laterally from the piston rod 2. Dispose of the handle. 2 1 w WARNING During disposal, ensure that no third party could injure themselves. 13 To connect the reservoir to the pump base in the next step, you first have to remove the reservoir cap. 4 73 Putting the Components into Operation 4.3.3 Connecting the Reservoir to the Pump Base4.3.4 Connecting the Reservoir to the Pump Base 3 When both components are connected to each other correctly and the battery is activated, the micropump issues the “Start” signal sequence. If this sequence of signals is not issued, check whether the battery is activated and repeat Steps 1 to 3. Make sure that there is no gap between the reservoir and the pump base. The pump base and the reservoir are only connected correctly when the "Start” signal sequence is issued and when the pump base and the reservoir are seamlessly connected. 4 1 Align the piston rod of the filled reservoir such that you can insert it into the piston rod opening of the pump base. 2 Push the filled reservoir onto the pump base until both parts are tightly connected. 74 Putting the Micropump into Operation 56 Read the reservoir level using the reservoir scale. With 2.0 ml (200 U), the reservoir shown in the figure above is full. Use and to set the number of 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. Note jDo not exert too much force when connecting the pump base to the reservoir. jMake sure that the opening for ventilation of the micropump is always clear so that the battery is fully functional. jFor more information on the sequences of signals, see chapter 17.3 Signals. 4 75 Putting the Components into Operation 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 t…
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84 Putting the Micropump into Operation On the Status screen, tap the symbol to restart the micropump. In the Main menu, tap Start . Starting or stopping insulin delivery While the micropump is in STOP mode, the micropump issues the “Cancel” signal sequence once an hour to remind you that no insulin is being delivered. For more information on the sequences of signals, see chapter 17.3 Signals. w WARNING Should you be unable to stop the micropump for any reason, remove the micropump from the infusion assembly, or pull the infusion assembly’s adhesive pad together with the micropump off your skin. Note Stopping the micropump cancels all ongoing boluses and the Temporary Basal Rate. The selected basal rate profile will be stopped until the micropump will be restarted again. or In the next step, you are prompted to activate the basal rate profile. After pressing the insulin button lit up in green to confirm, the micropump is set into operation again. 5 85 5 Testing or Entering Your Blood Glucose Level Blood glucose results are specified in mg/dL units of measurement. jYou need the diabetes manager, a test strip, a lancing device and a lancet. jSet up the diabetes manager before testing your blood glucose for the first time. jRead the test strip package insert. In the package insert, you will find further important information on storage, accuracy and precision of test results, and possible causes of incorrect test results. Mannheim, Germany mg/dLDiabetes manager Note jThe unit of measurement that your diabetes manager displays cannot be changed. Contact the Accu-Chek Customer Care Service Center if the wrong unit of measurement is printed on the back. jNever use a diabetes manager with an incorrect unit of measurement. This may cause the wrong therapy decision to be made and thus produce serious adverse health effects. 5.1 Testing Blood Glucose 5.1.1 Checking the Unit of Measurement 86 Testing or Entering Your Blood Glucose Level 5.1.2 Performing a Blood Glucose Test After inserting a lancet into the lancing device and setting the penetration depth, you can start the blood glucose test. w WARNING jA 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. jA contaminated puncture site may lead to incorrect test results and infections. Wash your hands and the puncture site with warm water and soap and rinse them well. jThe diabetes manager…
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9115 Hague Road · Indianapolis · United States
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 575.00 µW |
Instant blood glucose meter
Equipment Class
DTS - Digital Transmission SystemInstant blood glucose meter
Equipment Class
DTS - Digital Transmission System
Hand Held Blood Glucose Meter
Equipment Class
DSS - Part 15 Spread Spectrum Transmitter