Roche USA – 50162 V6/4 – 06333630001 – Yellow – Owner’s .
This file may not printor view at 100%.Die lines and colorbreaks do not print.Roche USA – 50162V6/1 – 06333630001 – Schwarz –Roche USA – 50162V6/2 – 06333630001 – Cyan –BLOOD GLUCOSE METER / MEDIDOR DE GLUCEMIARoche USA – 50162V6/3 – 06333630001 – Magenta –Roche USA – 50162V6/4 – 06333630001 – Yellow –Owner’s Booklet for Self-Testing Only /Manual del usuario únicamente paraautocontrolRoche USA – 50162V6/5– 06333630001 – PMS 300 –Roche USA – 50162V6/6 – 06333630001 –PMS 5445 –
Dear ACCU‑CHEK System Owner,Thank you for choosing the ACCU‑CHEK Nano SmartView system!Congratulations on your decision to take control of your diabetes. We’ve designed the new ACCU‑CHEKNano SmartView system with comfort, convenience, and control in mind to help make living with diabetesa little easier.This booklet will help you get the most from your ACCU‑CHEK Nano SmartView system.To start testing quickly, refer to the Quick Start Guide.If you have questions, we are here to help. Just contact the ACCU‑CHEK Customer Care Service Centertoll‑free at 1-800-858-8072. We offer assistance 24 hours a day, 365 days a year in many languages. Youcan also visit accu‑chek.com for diabetes management tools and product demonstrations.Thanks again for choosing the ACCU‑CHEK Nano SmartView system.1This file may not printor view at 100%.Die lines and colorbreaks do not print.Roche USA – 50162V4/1 – 06333630001 – Schwarz –Roche USA – 50162V4/2 – 06333630001 – Cyan –Roche USA – 50162V4/3 – 06333630001 – Magenta –Roche USA – 50162V4/4 – 06333630001 – Yellow –WarningBefore using the system, please read the Important Safety Information section on the followingpages.
2
ContentsIntroduction.7The ACCU‑CHEK Nano SmartView System. 7Important Safety Information. 9About Testing Yourself or Others.10Before You Start Testing.11Chapter 1: Understanding Your New System.13Using the ACCU‑CHEK Nano SmartView System.15Chapter 2: Control Testing.17Why Perform a Control Test.17About the Control Solution.18Performing a Control Test.19Understanding Out-of-Range Control Test Results.23Chapter 3: Testing Your Blood Glucose.25Using the ACCU‑CHEK FastClix Lancing Device.25Inserting a Lancet Drum.27Preparing the Lancing Device for Fingertip Testing.28Performing a Blood Glucose Test with Blood from Your Fingertip.29Changing the Lancet Drum.34Performing a Blood Glucose Test with Blood from Your Palm (Alternate Site Testing).36Marking Test Results and Setting the Post-Meal Test Reminder.44Unusual Test Results.46Symptoms of Low or High Blood Glucose.47Comparing Your Meter Result to a Laboratory Result.483
Chapter 4: Meter Memory, Setup, and Data Transfer.494Memory.49Viewing Test Results.50Meter Setup.52Setting the Time and Date.53Setting the Beeper On/OFF.55Setting the Post-Meal Test Reminder.57Setting the Test Reminders.59Setting the Hypoglycemic (Hypo) Alert.62Transferring Results to a Computer.65Chapter 5: Cleaning and Disinfecting the Meter and Lancing Device.67Cleaning and Disinfecting the Meter.69Cleaning and Disinfecting the Lancing Device.74Chapter 6: Maintenance and Troubleshooting.79Meter Maintenance.79Changing the Batteries.80Display and Error Messages.81Chapter 7: Technical Information.87Product Limitations.87Specifications.87Product Safety Information.89Travel Documentation.89Disposing of the Meter, Test Strips, Lancets, and Batteries .90Explanation of Symbols.91Warranty . .92
Limited License.94Additional Supplies.96Index.995
6
IntroductionThe ACCU‑CHEK Nano SmartView SystemThe ACCU-CHEK Nano SmartView blood glucose monitoring system is intended to be used for thequantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from thefingertips or palm. The ACCU-CHEK Nano SmartView blood glucose monitoring system is intended to be usedby a single person and should not be shared.The ACCU-CHEK Nano SmartView blood glucose monitoring system is intended for self testing outside thebody (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness ofdiabetes control. The ACCU-CHEK Nano SmartView blood glucose monitoring system should not be used forthe diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done onlyduring steady-state times (when glucose is not changing rapidly).The ACCU-CHEK SmartView test strips are for use with the ACCU-CHEK Nano blood glucose meter toquantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertipsor palm.This system is intended to be used by a single person and should not be shared.NoteThe term “blood glucose” is used when referring to “blood sugar” in this booklet.7
The ACCU‑CHEK Nano SmartView blood glucose monitoring system includes:8 ACCU‑CHEK Nano meter with batteries ACCU‑CHEK SmartView test strips* ACCU‑CHEK SmartView control solution* ACCU‑CHEK FastClix lancing device*(with a black cap for fingertip testing and an AST cap** for alternate site testing) ACCU‑CHEK FastClix lancet drum**may be sold separately**available upon request from the ACCU‑CHEK Customer Care Service CenterNeed Help?Just contact the ACCU‑CHEK Customer Care Service Center toll-free at 1‑800‑858‑8072. We offer assistance24 hours a day, 365 days a year in many languages. You can also visit accu-chek.com for diabetesmanagement tools and product demonstrations.Please complete the warranty card and mail it, so you receive the best customer service possible andproduct update news.
Important Safety InformationWarning During normal testing, any blood glucose meter or lancing device may come in contact with blood.All parts of the kit are considered biohazardous and can potentially transmit infectious diseasesfrom bloodborne pathogens, even after you have performed cleaning and disinfecting.1,2 The meter and lancing device should never be used by more than one person. Do not share themeter and lancing device with anyone, including family members, due to the risk of infectionfrom bloodborne pathogens.1,2 Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all,bloodborne pathogens.3 If the meter is being operated by a second person who is providing testing assistance to theuser, the meter and lancing device should be cleaned and disinfected prior to use by the secondperson. Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allowanyone else to test with the meter or lancing device. It is important to keep the meter and lancing device clean and disinfected. For instructions onhow to clean and disinfect the meter and lancing device, see Chapter 5, Cleaning andDisinfecting the Meter and Lancing Device. Wash hands thoroughly before and after handling the meter, lancing device, or test strips.9
10About Testing Yourself or OthersWarning If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If youthink you are dehydrated, contact your healthcare professional right away. DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE TEST RESULT THAT DOES NOT MATCHHOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT. Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia).Others, such as children or people who are unconscious or have certain disabilities, may notbe able to communicate their symptoms to caregivers. For these reasons, do not change anytreatment without first talking to a healthcare professional. It is always a good idea to have a back-up testing method available. Failure to test could causea delay in treatment decisions and lead to a serious medical condition. Examples of back-uptesting methods include a back-up meter or testing by a laboratory. Ask your healthcareprofessional or pharmacist about other possible back-up methods. If your blood glucose result does not match how you feel and you have followed theinstructions in this Owner’s Booklet, follow your healthcare professional’s instructions, orcontact your healthcare professional.NOTE Perform a control test when you open a new box of test strips or if you think that a test result isincorrect. Performing a control test lets you know that the meter and test strips are workingproperly. Refer to the test strip and control solution package inserts for additional health-relatedinformation.
Before You Start TestingAbout the Meter and Test StripsWarning Carefully read and follow the instructions in the Owner’s Booklet and package inserts for thetest strips and control solution. It is very important to follow the instructions in order toprevent a wrong result or improper treatment. Inspect the container of test strips before using the test strips for the first time. If you see anydamage to the container cap or if anything prevents the cap from closing properly, do not usethe test strips. Contact the ACCU‑CHEK Customer Care Service Center. Damaged test strips cancause inaccurate results, which could lead to improper treatment. The meter, test strips, and control solution are only for use outside the body (in vitro). Do noteat the test strips. Do not swallow or inject the control solution or use the control solution forany purpose other than testing the ACCU‑CHEK Nano SmartView system.NOTE Set the time and date on the meter before you begin testing. Although you always apply fresh capillary whole blood to the test strip, the system has beencalibrated to deliver plasma-like values for easier comparison to lab results.Special Information for Caregivers Do not use this device to measure blood glucose in people who are experiencing cardiovascular collapse(severe shock) or decreased peripheral blood flow. Consult your healthcare professional to determine if it is appropriate for your child to be taught how to usethe meter system or any other medical products.11
12
Chapter 1: Understanding Your New System13Right Arrow and LeftArrow Buttons –Press to enter memory,adjust settings, and scrollthrough test results.Infrared (IR) Window –Transfers data from themeter to a computer.Power/Set Button –Turns the meteron or off and setsoptions.Display –Shows results, messages,and test results stored inmemory.Battery Drawer –Pull out the batterydrawer to replacebatteries, whenneeded.Test Strip Slot –Insert test strip here.Front ViewBack ViewBatteries –Insert into battery drawerwith ( ) side facing down.
Golden End –Insert this end ofthe test strip intothe meter.AST Cap (for obtainingblood from sites other thanyour fingertip)14Yellow Window –Touch blood dropor control solutionhere.Test StripPower/SetButtonTest Strip ContainerControl SolutionBottleComfort Dial withDepth SelectionLancet CounterLancet DrumRelease ButtonSide ViewInfrared (IR) WindowCapRight ArrowButtonLeft ArrowButtonTop ViewNoteSome items may be sold separately.Depth IndicatorLever (for advancing to new lancet)Lancing Device
Using the ACCU‑CHEK Nano SmartView System Only use ACCU‑CHEK SmartView test strips.Refer to the test strip package insert for test strip storage and system operating conditions.Store the unused test strips in their original container with the cap tightly closed.Close the container tightly immediately after removing a test strip. Moisture can damage the test strips andproduce incorrect results.Do not remove test strips from the test strip container and put them into another container, such as aplastic bag, pocket, purse, wallet, etc.Discard the test strips if they are past the Use By date printed on the test strip container. If the Use By dateis missing or cannot be read, do not use the test strips. Contact the ACCU‑CHEK Customer Care ServiceCenter at 1‑800‑858‑8072.Use the test strip immediately after removing it from the container.Do not apply blood or control solution to the test strip before inserting it into the meter. If a result appearsbefore applying blood or control solution, do not act on that result.Do not reuse test strips. Once control solution or blood has been applied to a test strip, discard it. If a retestis necessary, use a new test strip.Perform a control test every time you open a new box of test strips.15
Warning16 DO NOT expose test strips to heat, moisture, or humidity. Temperatures outside the requiredrange, as well as moisture and humidity, can damage the test strips and lead to inaccurateresults. DO NOT bend, cut, or alter the test strips. DO NOT get dirt, food, or other material on the test strip.Not following these precautions can lead to inaccurate results.
Chapter 2: Control TestingWhy Perform a Control TestPerforming a control test lets you know that the meter and test strips are working properly. You shouldperform a control test when: You open a new box of test strips You left the test strip container open or you think the test strips have been damaged The test strips were stored in extreme temperatures and/or humidity You want to check the meter and test strips You dropped the meter Your test result does not match how you feel You want to check if you are testing correctly17
About the Control Solution18 Only use the ACCU‑CHEK SmartView control solution. Close the control solution bottle tightly after use. Write the date you open the control solution bottle on the bottle label. The control solution must bediscarded 3 months from the date the bottle was opened (discard date) or on the Use By date on thebottle label, whichever comes first. Do not use control solution that is past the Use By or discard date. Refer to the control solution package insert for control solution storage conditions. The meter automatically recognizes the difference between the control solution and blood. The control results are not displayed in memory. The control solution can stain fabric. Remove stains by washing with soap and water.
Performing a Control TestYou need the meter, a test strip, and control solution.191. To make sure the display is working properly, turn off the meter, then press and hold to see thecomplete display. All segments should be clear and look exactly like the picture. If any segments aremissing from the display, there may be a problem with the meter. Contact the ACCU‑CHEK Customer CareService Center at 1‑800‑858‑8072.NoteControl solution is available for purchase. To order the control solution, talk to your pharmacist or visitaccu-chek.com to order online. The meter automatically recognizes the difference between the controlsolution and blood. The control results are not displayed in memory.
202. Check the Use By date on thetest strip container. Do not usetest strips past the Use Bydate.3. Insert the test strip into themeter in the direction of thearrows.4. Place the meter on a flatsurface, such as table.
215. Remove the control bottle cap and wipe the tip ofthe bottle with a tissue.6. Squeeze the bottle until a tiny drop forms at thetip. Touch the drop to the front edge of the yellowwindow of the test strip. Do not put controlsolution on top of the test strip. When you seeflash, you have enough control solution in thetest strip.
22(in range example)7. Wipe the tip of the bottle with a tissue, then capthe bottle tightly. The result and the control bottlesymbol appear on the display.8. The control result and OK alternate on the displayif the result is in range. The range is printed onthe test strip container label. The control resultand Err alternate on the display if the result isnot in range. Remove and discard the used teststrip.
Understanding Out-of-Range Control Test ResultsWarningThe control range applies only to a control result. It only indicates that the test strips and meter areworking properly. Do not use a control result to interpret blood glucose results.If the control result is outside the acceptable range (printed on the test strip container), do not use the meteruntil you solve the problem. Check this list to help solve the problem:Troubleshooting ChecksAction1. Are the test strips or control solution past theUse By or discard date?If either is past the Use By or discard date, throw itaway.2. Did you wipe the tip of the control solutionbottle with a tissue prior to use?Wipe the tip of the bottle with a tissue. Repeat thecontrol test with a new test strip and a fresh drop ofcontrol solution.3. Were the test strip container and controlsolution bottle always closed tightly?If you think either may have been uncapped for sometime, replace the test strips or control solution.4. Was the test strip used immediately afterremoving it from the container?Repeat the control test with a new test strip and afresh drop of control solution.5. Were the test strips and control solution stored Repeat the control test with a properly stored testin a cool, dry place?strip or control solution.23
24Troubleshooting ChecksAction6. Did you follow all of the testing instructions?Read Chapter 2, Control Testing, and test again. If youstill have problems, contact the ACCU‑CHEK CustomerCare Service Center at 1‑800‑858‑8072.7. If you are still unsure of the problem Repeat the control test with a new test strip. If youstill have problems, contact the ACCU‑CHEK CustomerCare Service Center at 1‑800‑858‑8072.
Chapter 3: Testing Your Blood GlucoseUsing the ACCU‑CHEK FastClix Lancing DeviceWarning During normal testing, any blood glucose meter or lancing device may come in contact with blood.All parts of the kit are considered biohazardous and can potentially transmit infectious diseasesfrom bloodborne pathogens, even after you have performed cleaning and disinfecting.1,2 The meter and lancing device should never be used by more than one person. Do not share themeter and lancing device with anyone, including family members, due to the risk of infection frombloodborne pathogens.1,2 Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all,bloodborne pathogens.3 If the meter is being operated by a second person who is providing testing assistance to the user,the meter and lancing device should be cleaned and disinfected prior to use by the second person. Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allowanyone else to test with the meter or lancing device. It is important to keep the meter and lancing device clean and disinfected. For instructions on howto clean and disinfect the meter and lancing device, see Chapter 5, Cleaning and Disinfecting theMeter and Lancing Device. Wash hands thoroughly before and after handling the meter, lancing device, or test strips. You must not insert the lancet drum into the lancing device and simultaneously press therelease button or hold the lancing device with the release button resting on a surface such as atable top. This could release a lancet and inadvertently cause injury.25
Note Testing with blood from alternate sites requires the AST cap. This is explained later in the chapter. The best depth setting is the lowest number that lets you get enough blood for a test. Try differentsettings to find the one that is right for you. ALWAYS use a new, sterile lancet each time you test. Never reuse a lancet that has already been used. NEVER share your lancing device with anyone.26The black cap is for fingertip testing only.The AST cap is for testing other approved sites on the body, not the fingertip.*A new drum is dark gray with a white end.A used drum has a visible red stripe on the white end. You cannot insert a used drum into thelancing device.*available upon request from the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072
Inserting a Lancet DrumYou must first load the drum into the lancing device to get it ready for use.WarningYou must not insert the lancet drum into the lancing device and simultaneously press the releasebutton or hold the lancing device with the release button resting on a surface such as a table top.This could release a lancet and inadvertently cause injury.271. Remove the cap bypulling it straight off.Do not twist. Theeasiest way to do thisis to place your thumbto the side of thenotch as seen in theillustration.NOTE2. Insert a new drum,white end first, untilit clicks firmly intoplace.3. Slide the cap on untilit stops by aligningthe notch on the capwith the notch on thedevice.4. You are now ready touse the first lancet.The lancet counter onthe device shows anumber 6, meaningyou have six newlancets remaining.Once the drum is inserted into the lancing device, do not remove the drum until completely used. The drumcannot be reinserted.
Preparing the Lancing Device for Fingertip TestingWarningUse a new lancet for each fingerstick to avoid infection.281. Make sure the black cap is on the lancing device.Do not use the AST cap to perform a fingertip test.2. Adjust the lancet depth by turning the Comfort Dial.The depth indicator shows the current depthselection. The higher the number, the deeper thepenetration. If you have soft skin, we suggeststarting at a depth of 2. If your skin is calloused orthick, try a higher setting.3. Set the lancing device aside until you are ready toperform a fingerstick.
Performing a Blood Glucose Test with Blood from Your FingertipBefore you perform your first blood glucose test, set up the meter correctly and perform a control test.You need the meter, a test strip, and a lancing device with a drum loaded to perform a blood test.Warning During normal testing, any blood glucose meter or lancing device may come in contact withblood. All parts of the kit are considered biohazardous and can potentially transmit infectiousdiseases from bloodborne pathogens, even after you have performed cleaning anddisinfecting.1,2 The meter and lancing device should never be used by more than one person. Do not share themeter and lancing device with anyone, including family members, due to the risk of infectionfrom bloodborne pathogens.1,2 Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all,bloodborne pathogens.3 If the meter is being operated by a second person who is providing testing assistance to theuser, the meter and lancing device should be cleaned and disinfected prior to use by thesecond person. Disinfect the meter and lancing device before allowing anyone else to handle them. Do notallow anyone else to test with the meter or lancing device. It is important to keep the meter and lancing device clean and disinfected. For instructions onhow to clean and disinfect the meter and lancing device, see Chapter 5, Cleaning andDisinfecting the Meter and Lancing Device. Wash hands thoroughly before and after handling the meter, lancing device, or test strips.29
301. To make sure the display isworking properly, turn off themeter, then press and holdto see the complete display. Allsegments should be clear andlook exactly like the picture. Ifany segments are missing fromthe display, there may be aproblem with the meter.Contact the ACCU‑CHEKCustomer Care Service Centerat 1‑800‑858‑8072.2. Wash your hands with warmsoapy water and drythoroughly. Dirty or wet handscould affect results.3. Prepare the lancing device.4. Check the Use By date on thetest strip container. Do not usetest strips past the Use Bydate.
5. Insert the test strip into themeter in the direction of thearrows. The meter beeps.6. The meter beeps again and aflashing blood drop symbolappears.7. Place the lancing device firmlyagainst the side of yourfingertip. Remember that theopening where the lancetcomes out is not in the centerof the cap. Press the releasebutton on the end of the deviceall the way down to prick thefinger. The ACCU‑CHEK FastClixlancing device is primed andpricks the finger in a singlepush of the release button.31
WarningIf mg/dL does not appear with the test result, contact the ACCU‑CHEK Customer Care ServiceCenter at 1‑800‑858‑8072. Use of the wrong unit of measure may cause misinterpretation of youractual blood glucose level, and may lead to incorrect treatment.328. Gently squeeze your finger toassist the flow of blood. Thishelps you get a blood drop.9. Touch the blood drop to thefront edge of the yellowwindow of the test strip. Donot put blood on top of thetest
The ACCU‑CHEK nano SmartView System The ACCU‑CHEK Nano SmartView blood glucose monitoring system is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm. The ACCU‑CHEK Nano SmartView blood glucose monitoring system is intended to be used
16390 16400 16410 16420 16430 16440 FBI A1 (L15997) Roche (F15975) HV1 16093 16126 16129 HVI C-stretch Roche IA Roche ID Roche IE Roche IC HV1 FBI B1 (H16391) Roche (R16418) Hypervariable Region I 16024-16365 342 bp examined SSO Probes 16093 16126 16129
Michael Crowley, Head of Business Development Roche Research & Early Development, Pharma Partnering Roche Company Presentation. 2 The Roche Group: an innovation-driven company Why we make a good partner What we are looking for from you. 3 What we are looking The Roche Group: an for from you
Roche und der Geschäftsleitung der Roche in Verhandlungen mit dem AVR erarbeitet worden. und gelten für folgende Roche-Gesellschaften, inkl. ihrer Zweigniederlassungen in der Schweiz: . – Individuelle Leistungen und Beiträge zum Erfolg von Roche werden vom Arbeitgeb
Investor Update F. Hoffmann-La Roche Ltd 4070 Basel Switzerland Investor Relations email: investor.relations@roche.com Tel. 41 61 68-88880 Fax 41 61 69-10014 www.roche.com 1/11 Basel, 30 January 2020 Roche reports very strong results in 2019 1Group sales increase 9% at constant exchange rates and 8% in Swiss francs, driven by new products,
the cobas t 411 coagulation analyzer is the first member in Roche’s new series of coagulation analyzers. Quality and reliability Proven premium Roche quality means the cobas t 411 coagulation analyzer is reliable and robust with minimum downtime. Combined with an established, experienced global support network Roche ensures maximum up-time.
Source of Saturn’s Rings The moon’s own gravity tends to hold it together. Tidal forces from planet tend to pull it apart The “Roche Limit” is the critical distance where the two balance Saturn’s moons are (mostly) outside of Roche Limit Saturn’s rings are (mostly) inside the Roche limit. Roche Limit (2.4 Saturn .
The court also received evidence from Ms Maria Roche. Ms Roche is the Tumut Cluster Manager for Murrumbidgee Local Health District. As at 1 January 2016, Ms Roche was the Acting Rural Group Manager for the Riverina Group, which included Tumut Health Service. She had been in that role since 2013. Ms Roche gave oral evidence but also provided four
and act according to the Roche mission statement. The work of our employees affects the life of patients worldwide, from prevention through to medicinal products. They share their knowledge between the Pharma and Diagnostics Divisions, as well as worldwide within the Roche Group. This requires courage and vision, tackling of problems, and an
