User Manual for ACCU-CHEK models including: SN973, Blood Glucose Meter
The Accu-Chek Instant System. The Accu-Chek Instant test strips with the. Accu-Chek Instant meter are intended to quantitatively measure glucose in fresh.
New! Accu-Chek Instant (SN973) | Singapore
User's Manual Blood Glucose Meter Contents Introduction .................................................................................................................... 2 Chapter 1: Your New System.......................................................................................... 4 Chapter 2: Blood Glucose Tests...................................................................................... 9 Chapter 3: Control Tests............................................................................................... 15 Chapter 4: Review Your Data........................................................................................ 18 Chapter 5: Wireless Communication and Meter Pairing ................................................ 20 Chapter 6: Connecting to a PC ..................................................................................... 22 Chapter 7: Meter Maintenance and Troubleshooting..................................................... 23 Chapter 8: Technical Information.................................................................................. 30 Chapter 9: Guarantee................................................................................................... 34 Index ............................................................................................................................ 35 1 Introduction The Accu-Chek Instant System The 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 effectiveness 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-testing The 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. · Keep new and used batteries away from children. Ingestion or insertion into the body may cause chemical burns, perforation of soft tissues, and death. Severe burns may occur within 2 hours of swallowing. If you think a battery might have been swallowed or placed inside any part of the body, seek medical attention immediately. · If the battery compartment does not close securely, stop using the product and keep it away from children. Contact Roche. · 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). 2 Introduction Why Regular Blood Glucose Testing Is Important Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day. We have made it as simple as possible. Important Information About Your New Meter · It is strongly recommended to have a back-up testing method available. Failure to test could cause a delay in therapy decisions and lead to a serious medical condition. Examples of back-up testing methods include a back-up meter and test strips. Ask your healthcare professional or pharmacist about other possible back-up methods. · The meter prompts you to set the time and date the first time you turn it on. · Check the time and date on the meter before you begin testing. Adjust the time and date if necessary. · Sample data screens are shown throughout the manual. Your data will differ. · If you follow the steps in this manual but still have symptoms that do not seem to match your test results, or if you have questions, talk to your healthcare professional. 3 1 Your New System The Accu-Chek Instant Meter 12 3 4 5 Right Side View Front View Left Side View 1. Up Button and Down Button Press to turn the meter on and off, adjust settings, and scroll through results. 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 Port Transfers data from the meter to a computer (PC). 5. Test Strip Ejector Press to remove test strip. 4 1 Your New System 6 Back View 6. Battery Door Open to replace batteries. 8 7 Underside View 7. Test Strip Slot Insert test strip here. 9 C B A 8. Test Strip Container* (for example) 9. Test Strip - Metallic End Insert this end into the meter. 10. Test Strip - Yellow Edge Touch blood drop or control solution here. 11. Control Solution Bottle* 12. Batteries *Some items may not be included in the kit. They are a separate purchase. 5 1 Your New System Using the Meter Buttons When instructed to press a meter button, press it briefly and release it. When instructed to press and hold a meter button, press and hold it for 3 or more seconds. Button Functions Here are the functions of the Up button and Down button on the meter. These functions are used throughout this manual. Button Function Turn the meter on. Action Press and release. [Up button] Increase an option. Move forward through results in memory. Set time and date selections. Press and hold. Turn meter off. Decrease an option. [Down button] Move back through results in memory. Press and release. Enter set-up mode. Enter Bluetooth pairing mode. Press and hold. Target Range w WARNING This function is no substitute for hypoglycemia training by your healthcare professional. Consult 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 70160 mg/dL (3.98.9 mmol/L). The target range can be set from a lower limit of 60140 mg/dL (3.37.8 mmol/L) to an upper limit of 90300 mg/dL (5.016.6 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. 6 1 Your New System Symbols Symbol Description 7-day average symbol. This indicates that you are viewing the 7-day average of your blood glucose results. 14-day average symbol. This indicates that you are viewing the 14-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. Bluetooth symbol Control bottle symbol Drop symbol Hourglass symbol Low battery symbol No data to display Pairing symbol. A flashing symbol indicates the meter is attempting to pair with a device. A solid symbol indicates the meter pairing was successful. Target range indicator arrow. When flashing, your blood glucose result is outside the target range. Temperature warning symbol Test strip symbol. A flashing symbol indicates the meter is ready for you to insert a test strip. Wireless symbol. A flashing symbol indicates the meter is attempting to connect to the paired device. A solid symbol indicates the meter is connected to a paired device. 7 1 Your New System Setting the Time and Date 1 Press to turn the meter on. The flashing test strip symbol appears on the display. 2 Press and hold until set-up appears on the display. The hour flashes. Press to increase the hour or press to decrease the hour. 3 Press and hold to set the hour and move to the next field. The minutes flash. Press to increase the minutes or press to decrease the minutes. 4 Repeat step 3 to adjust each field. After setting the year, press and hold until the flashing test strip symbol appears to save your settings. NOTE · The meter prompts you to set the time and date the first time you turn the meter on or if an error occurs. · Press and hold at any time until the flashing test strip symbol appears to perform a test. · The time and date on the meter synchronizes to the time and date on the paired device each time the meter sends data to the paired device. See the chapter Wireless Communication and Meter Pairing. 8 2 Blood Glucose Tests w WARNING Blood 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 Using the Accu-Chek Instant System perform a control test with control solution and a new, unused test strip to ensure the meter and test strips are working properly. Then repeat the blood glucose test with a new test strip. · Do not store test strips in high heat and moisture areas (bathroom or kitchen)! Heat and moisture can damage test strips. · 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 WARNING · If you drop the meter or drop the meter with a test strip inserted, the meter and/or test strip could be damaged. Discard the test strip and 9 2 Blood Glucose Tests Performing a Blood Glucose Test 2 with Blood from Your Fingertip w WARNING When performing a blood glucose test: If the control bottle symbol and the flashing L1 or L2 appear on the display with your blood glucose result, an error has occurred and the test result may be 3 inaccurate. · Do not act on the blood glucose result. · Discard the test strip and repeat the blood glucose test with a new test strip. 4 NOTE · 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 5 connected to a PC with a USB cable. 1 Wash your hands with warm soapy water and dry thoroughly. 6 Prepare the lancing device. 10 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. Insert the metallic end of the test strip into the meter. The meter turns on. When a flashing drop symbol appears, perform a fingerstick with the lancing device. Gently squeeze your finger to assist the blood flow. This helps you get a blood drop. 2 Blood Glucose Tests 7 8 Touch the yellow edge of the test strip to the blood drop. Do not put blood on top of the test strip. Remove your finger from the test strip when the flashing hourglass symbol appears. Failure to move your finger away from the test strip could give inaccurate test results. 9 or Blue Test result is above the target range. Green Test result is within the target range. Red Test result is below the target range. Press here to eject test strip. Your 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 by pulling the test strip out of the meter or by pushing the test strip ejector on the side of the meter. *The target range is set by default at 70160 mg/dL (3.98.9 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. 11 2 Blood Glucose Tests Performing a Blood Glucose Test with Blood from Your Palm, Forearm, or Upper Arm (Alternative Site Testing) w WARNING · Do not use alternative site testing to calibrate a continuous glucose monitoring system. · Do not use alternative site testing 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 differences may cause you to misinterpret your actual blood glucose level, leading to improper therapy and potential adverse health effects. Read the following section before you try testing from the forearm or upper arm. You may perform a forearm or upper arm test You may NOT perform a forearm or upper arm test · immediately before a meal. · while fasting. · 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 (hypoglycemia). · 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. 12 2 Blood Glucose Tests Unusual Blood Glucose Results If your blood glucose result does not match how you feel, check this list to help solve the problem. Troubleshooting Checks Action Did you wash your hands? Wash your hands with warm soapy water and dry thoroughly. Repeat the blood glucose test with a new test strip. Were 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, Repeat the blood glucose test with a properly dry place? 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 Perform a control test. See the chapter properly? Control Tests for instructions. Are you still unsure of the problem? Contact Roche. 13 2 Blood Glucose Tests Symptoms of Low or High Blood Glucose w WARNING If 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. Being 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 (hypoglycemia): Symptoms of hypoglycemia may include, but are not limited to, anxiety, shakiness, sweating, headache, increased hunger, dizziness, pale skin color, sudden change in mood or irritability, fatigue, difficulty concentrating, clumsiness, palpitations, and/or confusion. High blood glucose (hyperglycemia): Symptoms of hyperglycemia may include, but are not limited to, increased thirst, frequent urination, blurred vision, drowsiness, and/or unexplained weight loss. 14 3 Control Tests When to Perform a Control Test Performing 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 difference between the control solution and blood. · The control solution can stain fabric. Remove stains by washing with soap and water. Performing a Control Test w WARNING When performing a control test: If the control bottle symbol and the flashing L1 or L2 DO NOT appear on the display with your control result, an error has occurred and the control result may be inaccurate. · Do not act on the control result. · Discard the test strip and repeat the control test with a new test strip. You need the meter, a test strip, and control solution Level 1 or Level 2. 1 Check the use by date on the test strip container. Do not use test strips past the use by date. 2 Remove a test strip from the test strip container. Close the cap tightly. 15 3 Control Tests 3 7 or Insert the metallic end of the test strip into the meter. The meter turns on. A flashing drop symbol appears. 4 Select the control solution to test. You will enter the level later in the test. 5 Remove the bottle cap. Wipe the tip of the bottle with a tissue. Squeeze the bottle until a tiny drop forms at the tip. 6 Touch the drop to the yellow edge of the test strip. Do not put control solution on top of the test strip. A flashing hourglass symbol appears when there is enough control solution in the test strip. The control result, the bottle symbol, and the flashing L1 or L2 appear on the display. Press and hold to confirm the control level you tested. Press or to alternate between L1 and L2. 8 or OK appears if the control result is within range. Err appears if the control result is out of range. 9 Wipe the tip of the bottle with a tissue. Cap the bottle tightly. Remove and discard the used test strip. NOTE The meter turns off 90 seconds after a successful test or 15 seconds after the test strip is removed, provided no other action is taken. 16 3 Control Tests Understanding Out-of-Range Control Results w WARNING The control 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 Action Were 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 Repeat the control test with a new test strip and after it was removed from the test a fresh drop of control solution. strip container? 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. 17 4 Review Your Data Overview · The meter automatically stores at least 720 blood glucose results in memory with the time and date of the test. · Once 720 blood glucose results are in memory, adding a new blood glucose result deletes the oldest blood glucose result. · 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. · 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. · Once 30 control results are in memory, adding a new control result deletes the oldest control result. · Control results are not viewable in memory and are not included in the 7, 14, 30, or 90-day averages. w WARNING Do 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. NOTE The meter has time and date auto-sync capability when paired with a mobile device that will update the meter time and date automatically. Even if you use your meter in multiple time zones, results are stored from newest to oldest and not by time and date. Reviewing Blood Glucose Results in Memory 1 or With the meter off, press to view the most recent blood glucose result. 2 or Continue to press to view previous test results from newest to oldest. NOTE Press to move back through oldest to newest test result. 18 4 Review Your Data Reviewing Your Test Result Averages The meter uses all of your blood glucose results from the past 7, 14, 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. 1 or With the meter off, press to turn the meter on. The most recent blood glucose result appears on the display. 2 or 90-day average or 7-day average Press to see the 7-day average. Continue to press 30, and 90-day averages. The number of test results in the average = n. to move through your 7, 14, NOTE · Press to move back through averages to the most recent blood glucose result. · If the memory contains a result that is HI or LO, or is corrupt, then the time period and day/ave will flash to alert you that those results are not included in the average. 19 5 Wireless Communication and Meter Pairing Overview The 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 data. You can use this application to wirelessly and automatically synchronize your diabetes information between the meter and the mobile device. Pairing The 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 meter of each other. 1 On Your Mobile Device Open the app and select Pair Meter. If prompted, turn on Bluetooth. 2 On Your Meter With the meter off, press and hold until the Bluetooth symbol appears. The pairing symbol and wireless symbol both appear and flash. 3 On Your Mobile Device Within 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. The meter times out after 30 seconds once you are prompted to enter the PIN. 4 On Your Meter or OK appears if pairing is successful. Err appears if pairing is unsuccessful. NOTE The meter has time and date auto-sync capability when paired with a mobile device that will update the meter time and date automatically. Even if you use your meter in multiple time zones, results are stored from newest to oldest and not by time and date. Transferring Data Wirelessly If the meter is paired with a mobile device and Bluetooth is on, your test results will be sent to the paired device automatically. 20 5 Wireless Communication and Meter Pairing Turning Bluetooth Off Turn Bluetooth off to disable wireless communication (flight mode). Turning Bluetooth off will not unpair your meter. 1 or Turning Bluetooth On If you have turned Bluetooth off, follow these steps below to turn it back on. This will enable wireless communication with your mobile device. 1 or With the meter off, press to turn the meter on. The last test result appears. 2 or With the meter off, press to turn the meter on. The last test result appears. 2 or Press and hold until the Bluetooth symbol disappears. Press and hold until the Bluetooth symbol appears. 21 6 Connecting to a PC Connecting the Meter to a PC Using a USB Cable Follow 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. 1 Plug the small end of a USB cable into the meter. NOTE The USB cable does not charge the meter batteries. Remove the USB cable after you have finished. 2 Plug the large end of a USB cable into a USB port on the PC. If the meter is off, it turns on. 3 Start the diabetes management software and initiate a data transfer. 4 The meter transfers the data to the software. 22 7 Meter Maintenance and Troubleshooting Meter Maintenance The meter automatically tests its own systems every time you turn it on and lets you know if something is wrong. See the Error Messages section of this chapter. If you drop the meter or think the results are not accurate, contact Roche. w WARNING Keep new and used batteries away from children. See the warning in the Introduction of this User's Manual for additional information. Changing the Batteries 1 3 Slide the new batteries under the tabs with the (+) side facing up. Put the battery door back in place and snap it closed. Immediately discard the old batteries. NOTE · Always have a spare set of batteries. · Battery life may vary due to factors such as temperature and battery manufacturer. · The meter uses two 3-volt lithium batteries, coin cell type CR2032. This type of battery can be found in many stores. · Always replace both batteries at the same time and with the same brand. · Meter data is not lost when you replace the batteries. Open the child-resistant battery door by inserting a narrow object, such as a pen, into the slot (see image above). Push the tab in the direction of the arrow and lift the battery door up. 2 Remove the old batteries. Press and hold for at least 2 seconds. 23 7 Meter Maintenance and Troubleshooting Checking the Meter Display or With the meter off, press and hold 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. Cleaning and Disinfecting the Meter Keep 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 · If the meter is being operated by a second person who is providing testing assistance to the user, the meter should be disinfected prior to use by the second person. · Do not clean or disinfect the meter while performing a blood glucose or control test. · Do not allow liquid to enter any openings in the meter. · Do not spray anything directly onto the meter. · Do not immerse the meter in liquid. · Do not keep disinfecting wipes on the meter display longer than 10 minutes. When to clean or disinfect the meter: · Clean the meter to remove visible dirt or other material. · Disinfect the meter between each patient use. What to clean or disinfect: · The area around slots and openings · The meter display · The entire meter surface 24 7 Meter Maintenance and Troubleshooting 1 Make sure the meter is turned off. Gently wipe the meter surface with a soft cloth slightly dampened (wring out any excess liquid) with one of these solutions: To clean the meter Mild dishwashing liquid mixed with water To disinfect the meter 70 % isopropyl alcohol Note: During disinfection, make sure that the meter surface stays wet with isopropyl alcohol for 2 minutes. Additional wiping of the surface with cloths dampened with isopropyl alcohol may be necessary. 2 Dry the meter thoroughly with a soft cloth. Error Messages w WARNING · Never make therapy decisions based on an error message. · If you have any concerns or see any other error message, contact Roche. NOTE The error code and Err will alternate on the display for all coded error messages (E-1 through E 14). 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 location with a more moderate temperature. The 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. 25 7 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) The meter was unable to pair with a mobile device. Retry the pairing. The batteries are almost out of power. Change the batteries now. If the symbol reappears after the batteries have been replaced, remove the batteries again, press and hold either meter button for at least 2 seconds, then reinsert the batteries. (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. A meter or test strip error has occurred. This error message could appear if the cap on the test strip container was not closed tightly. The test strips may have been damaged due to improper storage or handling. Never make therapy decisions based on an error message. Repeat the blood glucose test. If a second E-3 error message appears, perform a control test with the control solution and a new test strip. See the Performing a Control Test section in the chapter Control Tests. If you continue to receive an E-3 error message, use an alternate method for testing your blood glucose, such as a back-up meter and test strip. If the alternate method gives an extremely high blood glucose result, or if an alternate method is not available, contact your healthcare professional immediately. In rare cases, an E-3 error message may indicate that your blood glucose is extremely high and above the system's measuring range. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests for other possible causes of the error message. 26 7 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) (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.) 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. (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 either meter button for at least 2 seconds, and reinsert the batteries. Perform a blood glucose or control test. The batteries may be out of power. Turn the meter back on. If you are in a cold environment, move to a location with a more moderate temperature and retest. If the message continues to appear after several attempts, replace the batteries. If the message reappears after the batteries have been replaced, remove the batteries, press and hold either meter button for at least 2 seconds, then reinsert the batteries. 27 7 Meter Maintenance and Troubleshooting (The error code and Err will alternate on the display.) (The error code and Err will alternate on the display.) The time and date setting may be incorrect. A flashing wireless symbol appears while the meter attempts to synchronize the time and date with the paired device. When the wireless symbol no longer appears, press the Up button to turn the meter off. Press the Up button a second time until the flashing test strip symbol appears. If time and date sync was not successful the meter prompts you to set them the next time you turn it on. See the Setting the Time and Date section in the chapter Your New System. (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.) 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. (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. An electronic error has occurred. Contact Roche. 28 7 Meter Maintenance and Troubleshooting Blood 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. 29 8 Technical Information Product Limitations See 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: -2570 °C Memory capacity At least 720 blood glucose results and at least 30 control results with time and date; and 7, 14, 30, and 90-day averages. Automatic off 90 seconds; or 15 seconds after a test strip is removed. Power supply Two 3-volt lithium batteries (coin cell type CR2032) Display LCD Dimensions 77.1 × 48.6 × 15.3 mm (LWH) Weight Approx. 43 g (with batteries) Construction Hand-held Protection class III Meter type The Accu-Chek Instant meter is suitable for continuous operation. Control solution storage conditions Refer to the control solution package insert. Interfaces USB: micro-B connector; Bluetooth low energy technology; 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). 30 8 Technical Information 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 Hereby, Roche declares that the radio equipment type Accu-Chek Instant blood glucose meter is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: http://declarations.accu-chek.com Communication 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 2017 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. Product Safety Information · To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present. Discarding the Meter w 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. w 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. 31 8 Technical Information Explanation of Symbols These symbols may appear on the packaging, on the type plate, and in the instructions for the Accu-Chek Instant meter. B Consult instructions for use d Biological Risks used meters carry a risk of infection. W 2 Caution, refer to safety-related notes in the instructions for use accompanying this product. Temperature limit (store at) E Use by M Manufacturer R Catalogue number L Batch code I In vitro diagnostic medical device Q Global Trade Item Number q Serial number A l This product fulfils the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices. 3-volt coin cell type CR2032 g Keep new and used batteries away from children. 32 8 Technical Information Additional Supplies Test Strips: Accu-Chek Instant test strips Control Solutions: Accu-Chek Instant control solutions Information for Healthcare Professionals w WARNING Healthcare Professionals: Follow the infection control procedures appropriate for your facility. Refer to the test strip package insert for additional healthcare professional information. Sample Handling Always wear gloves when handling blood-contaminated items. Always adhere to the recognized 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 Patients Decisions 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 difference between fingertip or palm test results and test results obtained from the forearm or upper arm. The difference in capillary bed concentration and blood perfusion throughout the body can lead to sample site-to-site differences in blood glucose results. These physiological effects vary between individuals and can vary within a single individual based upon his or her behavior 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, affecting the test results obtained with blood from the forearm or upper arm. 33 9 Guarantee Guarantee The statutory provisions on rights in consumer goods sales in the country of purchase shall apply. 34 Index A alternative site testing 12, 33 averages 7, 19 B batteries, changing 23 battery type 23, 30 blood glucose results, unusual 13 blood glucose test, performing 9 button, functions 4, 6 C control results, out-of-range 17 control solution 15 control test, performing 15 D data transfer USB 22 wireless 20 E error messages 25 G guarantee 34 H healthcare professionals 33 high blood glucose 14 hyperglycemia 14 hypoglycemia 14 L low blood glucose 14 M maintenance, meter 23 meter, cleaning and disinfecting 24 meter memory 18 P product limitations 30 product safety information 31 product specifications 30 S supplies 5, 33 symbols IVD 32 meter display 7 T target range 11 target range indicator 4, 11 technical information 30 test strips 9 time and date, setting 8 U use by date 9, 15 W wireless communication auto-sync, time and date 18, 20 flight mode 21 pairing 20 transferring data 20 turning off 21 turning on 21 35 LAST UPDATE: 2020-08 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 India Accu-Chek Customer Helpline: 1800 120 6020 (Toll-free) www.accu-chek.in Hong Kong Enquiry hotline: +852-2485 7512 (office hours) www.accu-chek.com.hk Philippines Accu-Chek Customer Hotline: Phone: (02) 7718 7575 / (02) 7718 7588 / +63 917 8978000 www.accu-chek.com.ph Roche Pakistan Limited 37-B, 1st Floor, Block 6, PECHS Karachi - 75400 Pakistan Contact: 0800-76243 www.accu-chek.com.pk Roche Diabetes Care GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.accu-chek.com HIDF16000080 ACCU-CHEK and ACCU-CHEK INSTANT are trademarks of Roche. CONTINUA, the CONTINUA logos and CONTINUA CERTIFIED are trademarks, service marks, or certification marks of the Continua Health Alliance. CONTINUA is a registered trademark in some, but not all countries in which this product is distributed. 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. All other product names and trademarks are the property of their respective owners. © 2020 Roche Diabetes Care 09767959001-0920Adobe PDF Library 15.0