Roche Diabetes Care 122 Accu-Check Instant User Manual 54461 07947836001 07947836001 01

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User’s ManualBlood Glucose MeterThis ﬁle may not print or view at 100%.Die lines and color breaks do not print.“Holding Area” text, box and rules do not print.Roche USA – 54461 V1/1 – 07947836001 07947836001(01) – Black 54461_07947836001_07947836001_01_COVER.indb 1 10/3/16 8:02 AM

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This ﬁle may not print or view at 100%.Die lines and color breaks do not print.“Holding Area” text, box and rules do not print.Roche USA – 54461 V2/1 – 07947836001 07947836001(01) – Black Roche USA – 54461 V2/2 – 07947836001 07947836001(01) – PMS 320 ContentsIntroduction ............................................................................................................................3Chapter 1: Your New System ..................................................................................................5Chapter 2: Blood Glucose Tests .............................................................................................11Chapter 3: Control Tests ........................................................................................................19Chapter 4: Review Your Data.................................................................................................25Chapter 5: Wireless Communication and Meter Pairing .........................................................27Chapter 6: Connecting to a PC .............................................................................................. 31Chapter 7: Meter Maintenance and Troubleshooting .............................................................33Chapter 8: Technical Information ..........................................................................................41Chapter 9: Guarantee ............................................................................................................47Index ....................................................................................................................................4854461_07947836001_07947836001_01_Inside.indb 1 10/7/16 10:50 AM

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3IntroductionThe Accu-Chek Instant SystemThe Accu-Chek Instant test strips with the Accu-Chek Instant meter are intended to quantitatively measure glucose in fresh capillary whole blood from the ﬁnger, palm, forearm, and upper arm as an aid in monitoring the eectiveness of glucose control. The Accu-Chek Instant test strips with the Accu-Chek Instant meter are intended for in vitro diagnostic self-testing by people with diabetes. The Accu-Chek Instant test strips with the Accu-Chek Instant meter are intended for in vitro diagnostic use by healthcare professionals in clinical settings. Venous, arterial, and neonatal blood testing is limited to healthcare professional use. This system is not for use in the diagnosis of diabetes mellitus, nor for testing neonate cord blood samples. Suitable for self-testingThe system includes:Accu-Chek Instant meter with batteries, Accu-Chek Instant test strips*, and Accu-Chek Instant control solutions*.*Some items may not be included in the kit. They are a separate purchase. wWARNING• Choking hazard. Small parts. Keep away from children under the age of 3years. • Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Fourth Edition; CLSI document M29-A4, May 2014).Introduction54461_07947836001_07947836001_01_Inside.indb 3 10/7/16 10:50 AM

4Introduction54461_07947836001_07947836001_01_Inside.indb 4 10/7/16 10:50 AM

5Your New System 11. Meter ButtonPress to turn the meter on and o, move to the next screen, or make a selection.2. Display Shows results, messages, and test results stored in memory. 3. Target Range Indicator Indicates whether your blood glucose result falls above, within, or below a pre-set range of values. 4. Micro USB PortTransfers data from the meter to a computer (PC).The Accu-Chek Instant MeterChapter 1: Your New SystemRight Side View Front View Left Side View 132454461_07947836001_07947836001_01_Inside.indb 5 10/7/16 10:50 AM

6Your New System15. Battery Door Open to replace batteries.6. Test Strip SlotInsert test strip here. 5Back View Underside View 654461_07947836001_07947836001_01_Inside.indb 6 10/7/16 10:50 AM

7Your New System 17. Test Strip Container* 8. Metallic End Insert this end into the meter. 9. Yellow Edge Touch blood drop or control solution here. 10. Control Solution Bottle* 11. Batteries 12. USB Cable* Connects the meter to a PC. * Some items may not be included in the kit. They are a separate purchase. (for example) Test Strip78121191054461_07947836001_07947836001_01_Inside.indb 7 10/7/16 10:50 AM

8Your New System1Using the Meter ButtonYour new meter has only one button, but it performs many actions. Press the meter button once to turn the meter on and see your most recent blood glucose result. Continue pressing to view your 7-, 30-, and 90-day blood glucose averages.When instructed to press the meter button, press it brieﬂy and release it. When instructed to press and hold the meter button, press and hold it for 3 or more seconds.Time and DateTo display or change the time and date on the meter, pair the meter to a mobile device, or connect it to a PC with diabetes management software installed. Follow the diabetes management software instructions to set the time and date. The meter display will then show the time and date along with your test results.Target RangeConsult your healthcare professional for the blood glucose range appropriate for you. It is very important to stay within your target range.The target range is set by default at 70–160 mg/dL (3.9–8.9 mmol/L). The target range can be set from a lower limit of 60–140 mg/dL (3.3–7.8 mmol/L) to an upper limit of 90–300 mg/dL (5.0–16.6 mmol/L). To change the target range, pair the meter to a mobile device, or connect it to a PC with diabetes management software installed. Then follow the diabetes management software instructions.wWARNINGThis function is no substitute for hypoglycaemia training by your healthcare professional.54461_07947836001_07947836001_01_Inside.indb 8 10/7/16 10:50 AM

9Your New System 1SymbolsSymbol DescriptionLast test result symbol. This indicates that you are viewing your last blood glucose result. 7-day average symbol. This indicates that you are viewing the 7-day average of your blood glucose results. 30-day average symbol. This indicates that you are viewing the 30-day average of your blood glucose results.90-day average symbol. This indicates that you are viewing the 90-day average of your blood glucose results.Drop symbol Bluetooth® symbolControl bottle symbol Hourglass symbolLow battery symbolNo data to displayPairing symbol Target range indicator arrow. When ﬂashing, your blood glucose result is outside the target range.Temperature warning symbolWireless symbol 54461_07947836001_07947836001_01_Inside.indb 9 10/7/16 10:50 AM

10Your New System154461_07947836001_07947836001_01_Inside.indb 10 10/7/16 10:50 AM

11Blood Glucose Tests 2Chapter 2: Blood Glucose TestswWARNINGBlood glucose results can be displayed in either mg/dL or mmol/L. The back label of the meter shows the unit of measurement. If the meter shows the wrong unit, contact Roche. If you do not know which unit of measurement is correct for you, contact your healthcare professional. Using the wrong unit of measurement may cause misinterpretation of your actual blood glucose level and may lead to improper therapy. mg/dL or mmol/L is printed here 54461_07947836001_07947836001_01_Inside.indb 11 10/7/16 10:50 AM

12Blood Glucose Tests2Using the Accu-Chek Instant System• Use only Accu-Chek Instant test strips. • Use the test strip immediately after removing it from the test strip container. • Do not apply blood or control solution to the test strip before inserting it into the meter. • Close the test strip container tightly immediately after removing a test strip to protect the test strips from humidity. • Store the unused test strips in their original test strip container with the cap closed. • Check the use by date on the test strip container. Do not use the test strips after that date. • Store the test strip container and meter in a cool, dry place such as a bedroom. • Refer to the test strip package insert for test strip storage and system operating conditions. wWARNINGDo not store test strips in high heat and moisture areas (bathroom or kitchen)! Heat and moisture can damage test strips. Performing a Blood Glucose Test with Blood from Your FingertipNOTE• You need the meter, a test strip, and a lancing device with a lancet inserted to perform a blood glucose test. • A blood glucose test cannot be performed while the meter is connected to a PC with a USB cable. 54461_07947836001_07947836001_01_Inside.indb 12 10/7/16 10:50 AM

13Blood Glucose Tests 2Wash your hands with warm soapy water and dry thoroughly. Prepare the lancing device. 1Check the use by date on the test strip container. Do not use test strips past the use by date. Remove a test strip from the test strip container. Close the cap tightly.2 3Insert the metallic end of the test strip into the meter. The meter turns on.4When a flashing drop symbol appears, perform a fingerstick with the lancing device. 554461_07947836001_07947836001_01_Inside.indb 13 10/7/16 10:50 AM

14Blood Glucose Tests2Gently squeeze your finger to assist the blood flow. This helps you get a blood drop. 6Touch the yellow edge of the test strip to the blood drop. Remove your finger from the test strip when the flashing hourglass symbol appears. Do not put blood on top of the test strip. 754461_07947836001_07947836001_01_Inside.indb 14 10/7/16 10:50 AM

15Blood Glucose Tests 2Your test result appears with an arrow. This arrow shows if your test result falls above, within, or below the target range.* The target range is represented by the green region of the target range indicator. The arrow will ﬂash if your test result falls above or below this range. Remove and discard the used test strip.8*The target range is set by default at 70–160 mg/dL (3.9–8.9 mmol/L). To change the target range, pair the meter to a mobile device, or connect it to a PC with diabetes management software installed. Consult your healthcare professional before changing the target range. BlueTest result is above the target range.GreenTest result is within the target range.RedTest result is below the target range.or54461_07947836001_07947836001_01_Inside.indb 15 10/7/16 10:50 AM

16Blood Glucose Tests2Performing a Blood Glucose Test with Blood from Your Palm, Forearm, or Upper Arm (Alternative Site Testing)wWARNINGDo not use alternative site testing to calibrate a continuous glucose monitoring system or to make insulin dosing calculations.You have the option of obtaining a blood sample from other sites on your body besides the ﬁngertip. Alternative sites include the palm, forearm, and upper arm.Blood obtained from the ﬁngertip and palm can be used at any time to perform a blood glucose test.If blood from the forearm or upper arm is used, there are certain times when testing is not appropriate. This is because your blood glucose level changes faster in your ﬁngertip and palm than in the forearm and upper arm. These dierences may cause you to misinterpret your actual blood glucose level, leading to improper therapy and potential adverse health eects.Read the next section before you try testing from the forearm or upper arm.You may perform a forearm or upper arm test• immediately before a meal.• while fasting.You may NOT perform a forearm or upper arm test• up to 2hours following a meal, when blood glucose values can rise quickly.• after injecting bolus insulin, when blood glucose values can decrease rapidly.• after exercise.• if you are sick.• if you think your blood glucose is low (hypoglycaemia).• if you sometimes do not notice when your blood glucose is low.If you are interested in AST, talk to your healthcare professional ﬁrst.To obtain an AST cap and detailed AST instructions, contact Roche.54461_07947836001_07947836001_01_Inside.indb 16 10/7/16 10:50 AM

17Blood Glucose Tests 2Unusual Blood Glucose ResultsIf your blood glucose result does not match how you feel, check this list to help solve the problem.Troubleshooting Checks ActionWere the test strips expired? Discard the test strips if they are past the use by date. Repeat the blood glucose test with an unexpired test strip.Was the cap on the test strip container always closed tightly?Replace the test strips if you think the test strip container was uncapped for some time. Repeat the blood glucose test.Was the test strip used immediately after it was removed from the test strip container?Repeat the blood glucose test with a new test strip.Were the test strips stored in a cool, dry place? Repeat the blood glucose test with a properly stored test strip.Did you follow the directions? Read the chapter Blood Glucose Tests and repeat the blood glucose test. Contact Roche if you still have problems.Are the meter and test strips working properly? Perform a control test. See the chapter Control Tests for instructions.Are you still unsure of the problem? Contact Roche.54461_07947836001_07947836001_01_Inside.indb 17 10/7/16 10:50 AM

18Blood Glucose Tests2Symptoms of Low or High Blood GlucoseBeing aware of the symptoms of low or high blood glucose can help you understand your test results and decide what to do if they seem unusual.Low blood glucose (hypoglycaemia): Symptoms of hypoglycaemia may include, but are not limited to, anxiety, shakiness, sweating, headache, increased hunger, dizziness, pale skin colour, sudden change in mood or irritability, fatigue, diculty concentrating, clumsiness, palpitations, and/or confusion.High blood glucose (hyperglycaemia): Symptoms of hyperglycaemia may include, but are not limited to, increased thirst, frequent urination, blurred vision, drowsiness, and/or unexplained weight loss.wWARNINGIf you are experiencing any of these symptoms, or other unusual symptoms, test your blood glucose from the ﬁngertip or palm. If your blood glucose result is displayed as LO or HI, contact your healthcare professional immediately. 54461_07947836001_07947836001_01_Inside.indb 18 10/7/16 10:50 AM

19Control Tests 3When to Perform a Control TestPerforming a control test lets you know the meter and test strips are working properly. You should perform a control test when: • you open a new test strip box. • you left the test strip container open. • you think the test strips are damaged. • you want to check the meter and test strips. • the test strips were stored in extreme temperatures, humidity, or both. • you dropped the meter. • your test result does not match how you feel. • you want to check if you are performing the test correctly. About the Control Solutions• Use only Accu-Chek Instant control solutions. • 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 be discarded 3months from the date the control solution bottle was opened (discard date) or on the use by date on the bottle 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 dierence between the control solution and blood. • The control solution can stain fabric. Remove stains by washing with soap and water. Chapter 3: Control Tests54461_07947836001_07947836001_01_Inside.indb 19 10/7/16 10:50 AM

20Control Tests3Performing a Control TestYou need the meter, a test strip, and control solution Level 1 or Level 2. Check the use by date on the test strip container. Do not use test strips past the use by date. Remove a test strip from the test strip container. Close the cap tightly.1 2Insert the metallic end of the test strip into the meter. The meter turns on.3A flashing drop symbol appears.54461_07947836001_07947836001_01_Inside.indb 20 10/7/16 10:50 AM

21Control Tests 3Select the control solution to test. You will enter the level later in the test.4Remove the bottle cap. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip.5Touch the drop to the yellow edge of the test strip. Do not put control solution on top of the test strip. 6A ﬂashing hourglass symbol appears when there is enough control solution in the test strip.54461_07947836001_07947836001_01_Inside.indb 21 10/7/16 10:50 AM

22Control Tests3If you tested with Level 1 control solution, the L-1 screen appears. Press and hold the meter button to confirm that you tested with Level 1 control solution. The control result appears. Press the meter button.7or8orIf you tested with Level 2 control solution, the L-2 screen appears. Press and hold the meter button to confirm that you tested with Level 2 control solution.Press the meter button to alternate between L-1 and L-2. 54461_07947836001_07947836001_01_Inside.indb 22 10/7/16 10:50 AM

23Control Tests 3Wipe the tip of the bottle with a tissue. Cap the bottle tightly.Remove and discard the used test strip.10NOTEThe meter turns o 90seconds after a successful test or 15seconds after the test strip is removed, provided no other action is taken.OK appears if the control result is within range. 9orErr appears if the control result is out of range. 54461_07947836001_07947836001_01_Inside.indb 23 10/7/16 10:50 AM

24Control Tests3Understanding Out-of-Range Control ResultswWARNINGThe control solution ranges are printed on the test strip container label. If the control result is out of range, check this list to help solve the problem.Troubleshooting Checks ActionWere the test strips or control solutions expired? Discard the test strips or control solution if either is past the use by date. If the control solution was opened more than 3months ago, discard it. Repeat the control test with an unexpired test strip and an unexpired control solution. Did you wipe the tip of the control solution bottle before use?Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution.Were the caps on the test strip container and the control solution bottle always closed tightly?Replace the test strips or control solution if you think either was uncapped for some time. Repeat the control test.Was the test strip used immediately after it was removed from the test strip container?Repeat the control test with a new test strip and a fresh drop of control solution.Were the test strips and control solutions stored in a cool, dry place?Repeat the control test with a properly stored test strip or control solution.Did you follow the directions? Read the chapter Control Tests and repeat the control test.Did you choose the correct control solution level, either 1 or 2, when you performed the control test?If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container.Are you still unsure of the problem? Contact Roche.54461_07947836001_07947836001_01_Inside.indb 24 10/7/16 10:50 AM

25Review Your Data 4Chapter 4: Review Your DataWith the meter off, press the meter button to turn the meter on. The last test result symbol indicates that you are viewing your last blood glucose result.1Reviewing Your Last Blood Glucose ResultOverview• The meter automatically stores at least 720 blood glucose results in memory, but only the last blood glucose result and your 7-, 30-, and 90-day averages can be viewed on the meter. To view stored blood glucose results, transfer them to a compatible software application.• The meter automatically stores at least 30 control results in memory, but only the current control result can be viewed on the meter. To view stored control results, transfer them to a compatible software application.• If more than 720 blood glucose tests are performed within a 90-day period, only the 720 most recent test results are included in the 90-day average. • Control results are not included in the 7-, 30-, or 90-day averages. wWARNINGDo not change your therapy based on an individual test result in memory. Talk to your healthcare professional before changing therapy based on test results in memory.or54461_07947836001_07947836001_01_Inside.indb 25 10/7/16 10:50 AM

26Review Your Data4With the meter off, press the meter button to turn the meter on. Press the meter button to view your 7-, 30-, and 90-day averages.1Reviewing Your Test Result AveragesThe meter uses all of your blood glucose results from the past 7, 30, or 90 days to calculate a single number. This number is called the average, and helps you to understand your blood glucose results over a given period of time. ororor54461_07947836001_07947836001_01_Inside.indb 26 10/7/16 10:50 AM

27Wireless Communication and Meter Pairing 5OverviewThe process of creating a connection between the meter and the mobile device is called pairing. You will need an application on your mobile device that can accept the meter’s data. You can use this application to wirelessly and automatically synchronise your diabetes information between the meter and the mobile device.PairingThe meter can only pair with 1 device at a time. Pairing with a second device overwrites the ﬁrst pairing. The meter and the device to be paired should be within 1metre of each other. Chapter 5: Wireless Communication and Meter PairingOn Your Mobile DeviceOpen the app and select Pair Meter. If prompted, turn on Bluetooth.1On Your Meter2On Your Mobile DeviceWithin the app, select your meter from the list of found meters. When prompted, enter the 6-digit pin number located on the back of your meter.3With the meter off, press and hold the meter button until the Bluetooth symbol appears. The pairing symbol and wireless symbol both appear and flash. 54461_07947836001_07947836001_01_Inside.indb 27 10/7/16 10:50 AM

28Wireless Communication and Meter Pairing5OK appears if pairing is successful. Err appears if pairing is unsuccessful. 4Transferring Data WirelesslyIf the meter is paired with a mobile device and Bluetooth is on, your test results will be sent to the paired device automatically. On Your Meter54461_07947836001_07947836001_01_Inside.indb 28 10/7/16 10:50 AM

29Wireless Communication and Meter Pairing 5Turning Bluetooth OTurn Bluetooth o to disable wireless communication (ﬂight mode). Turning Bluetooth o will not unpair your meter.With the meter off, press the meter button to turn the meter on. The last test result screen appears.1Press and hold the meter button until the Bluetooth symbol disappears.2oror54461_07947836001_07947836001_01_Inside.indb 29 10/7/16 10:50 AM

30Wireless Communication and Meter Pairing5Turning Bluetooth OnIf you have turned Bluetooth off, follow the steps below to turn it back on. This will enable wireless communication with your mobile device.With the meter off, press the meter button to turn the meter on. The last test result screen appears.1Press and hold the meter button until the Bluetooth symbol appears.2oror54461_07947836001_07947836001_01_Inside.indb 30 10/7/16 10:50 AM

31Connecting to a PC 6Connecting the Meter to a PC Using a USB CableFollow the steps below to access diabetes management software on a PC. You can use this software to view stored results, set the meter time and date, and change the target range. Plug the small end of the USB cable into the meter. 1Plug the large end of the USB cable into a USB port on the PC. If the meter is o, it turns on. 2Start the diabetes management software and initiate a data transfer. 3Chapter 6: Connecting to a PCThe meter transfers the data to the software. 4NOTEThe USB cable does not charge the meter’s batteries. Remove the USB cable after you have ﬁnished.54461_07947836001_07947836001_01_Inside.indb 31 10/7/16 10:50 AM

32Connecting to a PC654461_07947836001_07947836001_01_Inside.indb 32 10/7/16 10:50 AM

34Meter Maintenance and Troubleshooting7With the meter o, press the meter button to turn the meter on. Press the meter button twice to display the 30-day average screen. 1Press and hold the meter button until all display segments appear. Check the meter display for missing segments. All segments should look like the picture above. If any segments are missing from the display, contact Roche, as there may be a problem with the meter.2Checking the Meter Displayoror54461_07947836001_07947836001_01_Inside.indb 34 10/7/16 10:50 AM

35Meter Maintenance and Troubleshooting 7Cleaning the MeterKeep the meter free of dust. If you need to clean or disinfect it, follow these guidelines carefully to help you get the best performance possible.wWARNING• Do not allow liquid to enter any openings in the meter.• Do not spray a cleaning solution directly onto the meter.• Do not immerse the meter in liquid.Make sure the meter is turned o.1Gently wipe the meter’s surface with a soft cloth slightly dampened (wring out any excess liquid) with one of these cleaning solutions:• 70% isopropyl alcohol• Mild dishwashing liquid mixed with water• 10% household bleach solution (1part bleach plus 9parts water) made the same day254461_07947836001_07947836001_01_Inside.indb 35 10/7/16 10:50 AM

36Meter Maintenance and Troubleshooting7The meter is connected to a PC and a blood glucose or control test cannot be performed. EITHER remove the USB cable and perform a blood glucose or control test OR remove the test strip and start a data transfer. The meter will not turn on or the display is blank. • Batteries are dead. Insert new batteries. • Display is damaged. / Meter is defective. Contact Roche. • Extreme temperatures. Move the meter to a more temperate area. The meter was unable to pair with a mobile device. Retry the pairing. Error MessageswWARNING• Never make therapy decisions based on an error message. • If you have any concerns or see any other error message, contact Roche. Error MessagesNOTE• The error code and Err will alternate on the display for all coded error messages (E-1 through E 14).54461_07947836001_07947836001_01_Inside.indb 36 10/7/16 10:50 AM

37Meter Maintenance and Troubleshooting 7(The error code and Err will alternate on the display.) The test strip may be damaged, not properly inserted, or was previously used. Remove and reinsert the test strip, or replace it if damaged or previously used. (The error code and Err will alternate on the display.)A meter or test strip error has occurred.Repeat the blood glucose test. If a second E-3 code appears, perform a control test with the control solution and a new test strip.• If the control result is within the acceptable range, review the proper testing procedure and repeat the blood glucose test with a new test strip.• If the control result is not within the acceptable range, see the Understanding Out-of-Range Control Results section in the chapter Control Tests.In rare cases, an E-3 error code may indicate that your blood glucose is extremely high and above the system’s measuring range. If you do not feel like your blood glucose is extremely high, repeat the blood glucose test. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. If the E-3 code still appears for your blood glucose test, contact your healthcare professional immediately.54461_07947836001_07947836001_01_Inside.indb 37 10/7/16 10:50 AM

38Meter Maintenance and Troubleshooting7(The error code and Err will alternate on the display.) Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started. Discard the test strip and repeat the blood glucose or control test. (The error code and Err will alternate on the display.) Blood or control solution was applied to the test strip before the ﬂashing drop symbol appeared on the display.Discard the test strip and repeat the blood glucose or control test. (The error code and Err will alternate on the display.) An electronic error occurred.Remove the batteries, press and hold the meter button for at least 2 seconds, and reinsert the batteries. Perform a blood glucose or control test.(The error code and Err will alternate on the display.) The temperature is above or below the proper range for the system. Refer to the test strip package insert for system operating conditions. Move to an area with the appropriate conditions and repeat the blood glucose or control test. Do not artiﬁcially heat or cool the meter. 54461_07947836001_07947836001_01_Inside.indb 38 10/7/16 10:50 AM

39Meter Maintenance and Troubleshooting 7(The error code and Err will alternate on the display.) The meter’s internal clock may need to be reset.Press the meter button. If the time and date were set, you will need to reset them. See the Time and Date section in the chapter Your New System.(The error code and Err will alternate on the display.) The test strip may be damaged. Repeat the blood glucose or control test with a new test strip.(The error code and Err will alternate on the display.) Your blood sample may contain a high level of ascorbate. Contact your healthcare professional. (The error code and Err will alternate on the display.) The batteries are almost out of power.Change the batteries now. If the message reappears after the batteries have been replaced, remove the batteries again, press and hold the meter button for at least 2 seconds, then reinsert the batteries.54461_07947836001_07947836001_01_Inside.indb 39 10/7/16 10:50 AM

40Meter Maintenance and Troubleshooting7Blood glucose may be higher than the measuring range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. Blood glucose may be lower than the measuring range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. (The error code and Err will alternate on the display.) An electronic error has occurred. Contact Roche. (The error code and Err will alternate on the display.) Fluid or foreign material may be present in the test strip slot. Remove and reinsert the test strip or repeat the blood glucose or control test with a new test strip. If the error persists, contact Roche. 54461_07947836001_07947836001_01_Inside.indb 40 10/7/16 10:50 AM

41Technical Information 8Product LimitationsSee the literature packaged with the test strips and control solutions for the latest information on product speciﬁcations and limitations. Speciﬁcations Blood volume Sample type Measuring time Measuring range Test strip storage conditions System operating conditions Refer to the test strip package insert. Meter storage conditions Temperature: -25–70°C Memory capacity 1blood glucose result and 7-, 30-, and 90-day test result averages (at least 720 blood glucose results and at least 30 control results are also stored and can be viewed with external software).Automatic o 90seconds after performing a test, 15 seconds after a test strip is removed, or 5 seconds from the last test result screen.Power supply Two3-volt lithium batteries (coin cell type CR2032) Display LCD Dimensions 77.1 × 48.6 × 15.3 mm (LWH)Weight Approx. 40g (with batteries) Construction Hand-held Protection class III Chapter 8: Technical Information54461_07947836001_07947836001_01_Inside.indb 41 10/7/16 10:50 AM

42Technical Information8Speciﬁcations Meter type The Accu-Chek Instant meter is suitable for continuous operation. Control solution storage conditions Refer to the control solution package insert. InterfacesUSB: micro-B connector; Bluetooth; Continua Certiﬁed® to a Continua Certiﬁed manager. Radio frequency connectivity Bluetooth low energy technology operating in the frequency band of 2402 MHz to 2480 MHz with a maximum transmitted power of 0 dBm (1 mW).Electromagnetic Compatibility – The meter meets the electromagnetic emission requirements as per EN 61326-2-6. Its electromagnetic emission is thus low. Interference on other electrically-driven equipment is not anticipated.Performance Analysis – Refer to the test strip package insert. Test Principle – Refer to the test strip package insert. Declaration of Conformity – Roche hereby declares that the Accu-Chek Instant blood glucose meter conforms with the basic requirements and other relevant regulations of the European Directives 1999/5/EC and 2014/53/EU once solely applicable. The transition period for the European Directive 1999/5/EC ends June 12th 2017. The currently valid conformity declaration may be found at the following Internet address: http://declarations.accu-chek.comCommunication Protocol – The Accu-Chek Instant blood glucose meter is Continua Certiﬁed. Continua Certiﬁed signiﬁes that this product complies with applicable IEEE 11073-10417 standards and that it has been tested and certiﬁed against the 2015 Continua Design Guidelines which include the Blood Glucose speciﬁcation for Bluetooth, Bluetooth SIG, Glucose Proﬁle, Version 1.0 and Bluetooth SIG, Glucose Service, Version 1.0.54461_07947836001_07947836001_01_Inside.indb 42 10/7/16 10:50 AM

43Technical Information 8Product Safety InformationwWARNING• Strong electromagnetic ﬁelds may interfere with the proper operation of the meter. Do not use the meter close to sources of strong electromagnetic radiation.• To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.Discarding the MeterwWARNING• During blood glucose testing, the meter itself may come into contact with blood. Used meters therefore carry a risk of infection. Before discarding the meter, remove the battery or batteries. Discard used meters according to the regulations applicable in your country. Contact the local council and authority for information about correct disposal.• The meter falls outside the scope of the European Directive 2012/19/EU – Directive on waste electrical and electronic equipment (WEEE).• Discard used batteries according to local environmental regulations.54461_07947836001_07947836001_01_Inside.indb 43 10/7/16 10:50 AM

44Technical Information8Explanation of SymbolsThese symbols may appear on the packaging, on the type plate, and in the instructions for the Accu-Chek Instant meter.Consult instructions for useBiological Risks – used meters carry a risk of infection.Caution, refer to safety-related notes in the instructions for use accompanying this product.Temperature limitation (store at)ManufacturerCatalogue numberIn vitro diagnostic medical deviceGlobal Trade Item NumberSerial numberThis product fulﬁls the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices.3-volt coin cell typeCR203254461_07947836001_07947836001_01_Inside.indb 44 10/7/16 10:51 AM

45Technical Information 8Additional SuppliesTest Strips: Accu-Chek Instant test stripsControl Solutions: Accu-Chek Instant control solutionsInformation for Healthcare ProfessionalswWARNINGHealthcare Professionals: Follow the infection control procedures appropriate for your facility. Refer to the test strip package insert for additional healthcare professional information.Sample HandlingAlways wear gloves when handling blood-contaminated items. Always adhere to the recognised procedures for handling objects that are potentially contaminated with human material. Follow the hygiene and safety policy of your laboratory or institution. Prepare the selected blood collection site per facility policy.Refer to the test strip package insert for additional information regarding acceptable sample types, anticoagulants, and handling instructions.Recommending Alternative Site Testing to PatientsDecisions about whether to recommend Alternative Site Testing (AST) should take into account the motivation and knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST. If you are considering recommending AST for your patients, you need to understand that there is a potential for a signiﬁcant dierence between ﬁngertip or palm test results and test results obtained from the forearm or upper arm. The dierence in capillary bed concentration and blood perfusion throughout the body can lead to sample site-to-site dierences in blood glucose results. These physiological eects vary between individuals and can vary within a single individual based upon his or her behaviour and relative physical condition.Our studies involving alternative site testing of adults with diabetes show that most persons will ﬁnd their glucose level changes more quickly in blood from the ﬁngertip or palm than in blood from the forearm or upper arm. This is especially important when blood glucose levels are falling or rising rapidly. If your patient is used to making therapy decisions based upon ﬁngertip or palm test results, he or she should consider the delay, or lag time, aecting the test results obtained with blood from the forearm or upper arm.54461_07947836001_07947836001_01_Inside.indb 45 10/7/16 10:51 AM

46Technical Information854461_07947836001_07947836001_01_Inside.indb 46 10/7/16 10:51 AM

47Guarantee 9GuaranteeThe statutory provisions on rights in consumer goods sales in the country of purchase shall apply.Chapter 9: Guarantee54461_07947836001_07947836001_01_Inside.indb 47 10/7/16 10:51 AM

48IndexIndexAalternative site testing 16, 45averages 9, 26Bbatteries, changing 33battery type 33, 41blood glucose results, unusual 17blood glucose test, performing 12button, functions 5, 8Ccontrol results, out-of-range 24control solution 19control test, performing 20Ddata transferUSB 31wireless 28Eerror messages 36Gguarantee 47Hhealthcare professionals 45high blood glucose 18hyperglycaemia 18hypoglycaemia 18Llast test result 25low blood glucose 18Mmaintenance, meter 33meter, cleaning 35Pproduct limitations 41product safety information 43product speciﬁcations 41Ssupplies 7, 45symbolsIVD 44meter display 9Ttarget range 8, 15target range indicator 5, 15technical information 41test strips 12time and date 8Uuse by date 12, 19Wwireless communicationﬂight mode 29overview 27pairing 27transferring data 28turning o 29turning on 3054461_07947836001_07947836001_01_Inside.indb 48 10/7/16 10:51 AM

LAST UPDATE: 2016-07Roche Diabetes Care South Africa (Pty) Ltd Hertford Office Park, Building E No 90 Bekker Street, Vorna Valley 1686 South Africa Accu-Chek Customer Care Centre: 080-DIABETES (Dial 080-34-22-38-37) www.accu-chek.co.za Hong Kong Enquiry hotline: +852-2485 7512 (office hours) www.accu-chek.com.hk Iran Customer Support: Tel: +98(21) 87175222 www.accu-chek.ir Islamic Republic of Pakistan Hotline number: 0800-76243 / 0800-ROCHE www.accu-chek.com.pk Philippines Customer Assist Care Hotline: (02) 718 7575 / (02) 718 7588 (+63) 917 897 8000 www.accu-chek.com Saudi Arabia / United Arab Emirates Master Distributor in the Middle East: Accu-Chek Enquiry Line: +971 (0) 4 8169 000 www.accu-chekarabia.com/arabic Singapore Accu-Chek ExtraCare line: 6272 9200 www.accu-chek.com.sg Thailand Customer Service Line: +66 (0) 2791 2222 www.accu-chek.co.th 54461_07947836001_07947836001_01_COVER.indb 3 10/3/16 8:02 AM