Blood Glucose Meter Owner s Manual

Transcription

1 Meter Owner s Manual

2 Preface Thank you for selecting the McKesson Quintet AC Monitoring System. Please read this manual thoroughly before you start testing. This User s Manual provides all of the necessary information needed to obtain correct test results. It is important to monitor blood glucose regularly. By testing accurately and frequently, complications can be reduced. The McKesson Quintet AC Monitoring System combines simple instructions and design with accurate testing results to provide a more reliable, user-friendly diabetes management system. The McKesson Quintet AC Monitoring System is intended for in vitro (outside the body) diagnostic use only. It is to be used for self-testing in the home or professional, clinical use. The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the fingertip, palm and forearm. You may consult your healthcare professional for instructions on how to use the system correctly. Our McKesson Brands Product Support Team is available to assist you as well. 2

3 Preface The McKesson Quintet AC Monitoring System is manufactured for and supported by McKesson Medical-Surgical Inc. and its authorized representative. If you have any questions or concerns, please contact your McKesson Quintet AC authorized representative or call us by telephone at A healthcare professional should be contacted when the authorized representatives are not available. Please forward your warranty card to Bionime authorized representative to activate your warranty coverage. 3

4 Precaution Before using the McKesson Quintet AC Monitoring System to test your blood glucose, read all the instructions in this user s manual and practice the tests including the quality control test. (Read all notes and precautions carefully.) Perform the quality control test regularly to make sure the test results are accurate. The McKesson Quintet AC Meter can only be used with the McKesson Quintet AC Test Strips. The use of other brands of strips is not advised and may result in inaccurate testing. The McKesson Quintet AC System is for in vitro diagnostic use only. The testing result is calibrated to be plasma equivalent for test with fresh capillary whole blood samples from the fingertip, palm or forearm. The McKesson Quintet AC System is intended for self-testing or professional use. It should not be used to diagnose diabetes mellitus. The McKesson Quintet AC System has not been validated for and should not be used on neonates. The McKesson Quintet AC Meter has not been tested for, and therefore should not be used for, arterial blood testing. Not to be exposed to dripping or splashing. 4

5 Precaution Wait to test at least 30 minutes after entering another location of a different ambient temperature. Pay attention to the environment protection policy when disposing of batteries. Only use the meter in environmental conditions of 10 C to 40 C (50 F to 104 F) and relative humidity (RH) of 10% to 90%. Sample Size Example Use a minimum of 0.75μL to test blood glucose levels. Blood sample size above 3.0μL may contaminate the test strip port and the meter. Blood sample size below 0.75μL may result in inaccurate test result or may not initiate meter measurement. In this case, repeat the test with a new test strip. The unit of measure must be fixed to mg/dl. When your display shows mmol/l during setting or test, please contact customer service. Use of the wrong unit of measure may cause incorrect results. Keep Control Solution, Test Strips, and all vials out of the reach of children. 5

6 Table of Contents About the McKesson Quintet AC Monitoring System The McKesson Quintet AC Monitoring System... 8 The McKesson Quintet AC Meter The McKesson Quintet AC Test Strip Preparing to Test Meter Activation and Battery Installation Setting Up the Meter: Setting the Time, Volume, and Date Turning On/Off the Meter Turning On/Off the Backlight Easily Handling the McKesson Quintet AC Test Strip Testing Procedure Preparing for Testing Performing a Test in Order Comprehending Test Results and Messages

7 Table of Contents Reviewing Test Memory Recalling Test Results and Average Test Results Quality Control About Quality Control Performing a Quality Control Test Understanding Control Test Results Caring for the Meter Error Messages and Troubleshooting Limitations Specifications Warranty Customer Service Expected Values for Normal Glucose Level Parts of Critical Component Log Book Emergency Card

8 The McKesson Quintet AC Meter The McKesson Quintet AC Monitoring System consists of several items. Please identify each item of the system and learn the name and function of each. The McKesson Quintet AC Monitoring System operates using the following items:: 1. Quick Start Guide 2. User s Manual 3. McKesson Quintet AC Test Strip Package Insert * 4. McKesson Quintet AC Control Solution Package Insert * 5. McKesson Quintet AC Meter (with 2 CR2032 batteries installed) 6. McKesson Quintet AC Test Strips * 7. McKesson Quintet AC Control Solution * 8. Carrying Case 9. Lancing Device * 10. Clear Cap * 11. Disposable Sterile Lancets (10pcs) (not shown) * 12. Instruction for the lancing device (not shown) * * Items are not included in your McKesson Quintet AC Monitoring System. 8

9 QUINTET AC QUINTET AC QUINTET AC The McKesson Quintet AC Meter 9

10 The McKesson Quintet AC Meter Test Strip Port Insert test strip here until you hear a click. Display Window Show test results, messages and relative information. Left Button ( ) For operating the meter, please check details in the following sections. QUINTET AC Main Button ( ) For operating the meter, please check details in following sections. Right Button ( ) For operating the meter, please check details in the following sections. 10

11 The McKesson Quintet AC Meter Battery Cover Slide cover to change batteries. Product Name Meter Serial Number Meter Battery Backlight Battery 11

12 12 The McKesson Quintet AC Meter

13 The McKesson Quintet AC Meter Indicates a test result stored in memory. Indicates a test result, not associated with the Average function of this meter. Indicates the average result. Indicates a control solution test result. Unit of test result. Test result. Warns when the battery is low or must be replaced. Manufacturing use only. Tells when to apply the blood sample. Test Strip. Warns when using the strip not suitable for your region test, or strip error. Current date under time mode or Testing date under memory mode. Indicates if the environmental temperature is exceeded during testing. Indicates the time in 12H format. Current time under time mode or Testing time under memory mode. 13

14 The McKesson Quintet AC Test Strip The McKesson Quintet AC Meter can only be used with McKesson Quintet AC Blood Glucose Test Strips. The application of other test strips or control solutions can lead to incorrect results. Sample Entry Apply the sample of blood or control solution here. The test requires a minimum of 0.75μL of blood to test blood glucose levels. Noble Metal Electrodes Electrochemical sensor. Indication Symbol Insert the test strip with the indication symbol upright and toward the meter. Hand Bar Grip here to insert the test strip into the meter. View Window Prior to blood sampling, this window will appear yellow. After obtaining the sample, it will gradually become red as it fills with blood. 14

15 The McKesson Quintet AC Test Strip Electrode Contacts Sensing signal output terminals. PRECAUTIONS Re-cap the test strip vial immediately after taking out a test strip. Do not reuse test strips. Do not use expired test strips. Record the date of opening a new test strip vial for the first time. Discard the vial of test strips after 3 month from opening. Store the test strips in a cool (4 C - 30 C or 39 F - 86 F) and dry location (< 90% relative humidity). Do not expose to direct sunlight or heat. For detailed information, please refer to the McKesson Quintet AC Test Strips Package Insert. If the McKesson Quintet AC Meters and Test Strips are exposed to a significant temperature difference, please wait 30 minutes before measurement. Keep test strips and vial out of reach of children. 15

16 Meter Activation and Battery Installation The McKesson Quintet AC Meter includes two CR2032, 3 volt batteries, installed. New batteries will provide the power to perform approximately 1,000 tests with normal use. You can press the main button or insert a strip to activate your meter. NOTE When the McKesson Quintet AC Meter s backlight has no function (you cannot see the backlight), please change your backlight battery. When the backlight s battery is running out of power, your McKesson Quintet AC Blood Glucose Meter will still work properly but without the backlight function. 16 PRECAUTION Please follow the local regulation and discard a used battery properly.

17 Meter Activation and Battery Installation 1. Turn the meter over. Press and push the battery cover to open. 2. Install both batteries at the same time. Check to make sure batteries are in the correct positions. 3. Slide the battery cover back until it snaps into place. 4. The McKesson Quintet AC Meter performs a self test. 5. Press any button to exit the self-test and enter the Setting Mode. 6. Set the time and date when the batteries are replaced, See Chapter Setting Up the Meter: Setting the Time, Volume and Date. Test results are still stored in the memory. 17

18 Setting Up the Meter: Setting the Time, Volume, and Date Entering Setting Mode The Setting Mode can be accessed by one of the two following directions: 1. Reload batteries: After removing the batteries, press the main button several times until there is nothing on the screen, then follow the battery installation steps to load the batteries. The meter will do a self test. Press the main button to close the electronic test of the meter and enter the setting mode. 2. With batteries loaded: Press and hold the main button for 7 seconds. The meter will first show a backlight and then will turn off. Continue pressing the main button until the meter sounds with a beep followed by the display screen showing setting data. NOTE When you press and hold the main button for 2 seconds, a backlight will show on the display screen. Continue to press the main button until the display is off. When you press and hold the main button for 4 seconds, the display will turn off. Continue to press the main button until entering setting data. A quick press of the main button allows you to change settings. If you want to return to the Time Mode, go through all of the settings by quickly pressing the main button. 18

19 Setting Up the Meter: Setting the Time, Volume, and Date 1. Year Setting With the year format blinking, press the Left or Right button on the side to adjust to the correct year. Press the main button to confirm the year adjustment and move to month setting. 2. Month Setting With the month blinking, press the Left or Right button until the current month appears. Press the main button to confirm the month adjustment and move to the day setting. 3. Day Setting With the day blinking, press the Left or Right button until the current day appears. Press the main button to confirm the day adjustment and move to time format setting. 19

20 Setting Up the Meter: Setting the Time, Volume, and Date 4. Time Format 12H/24H Selection With the time format blinking, press the Left or Right button on the side to adjust to the correct time. Press the main button to confirm the time format adjustment and move to the Hour setting. 5. Hour Setting With the hour blinking, press the Left or Right button until the current hour appears. Press the main button to confirm the hour adjustment and move to Minute setting. 6. Minute Setting With the minute blinking, press the Left or Right button until the current minute appears. Press the main button to confirm the minute and move to the Volume setting. 20

21 Setting Up the Meter: Setting the Time, Volume, and Date 7. Volume Setting With the volume blinking, press the Left or Right button to turn the volume on or off. Press the main button to confirm the volume and move to the Unit of Measurement setting. 8. Ending the Settings After the unit of measurement setting, you will hear a beep confirming that the settings are saved and completed (if the volume is turned on). At this time, you will return to the time screen. (If the volume is turned off, the display will directly return to the time screen without the sound of a beep.) NOTE If the meter is idle for over 2 minutes, the power will automatically turn off. 21

22 Turning On/Off the Meter 1. Power On Press the main button or insert one McKesson Quintet AC Test Strip. 2. Manual Power Off To manually power down the meter, press and hold the main button for 4 seconds. 3. Auto Power Off If the meter is idle for over 2 minutes, it will automatically power down. 22

23 Turning On/Off the Backlight 1. Backlight On Press and hold the main button for 2 seconds. 2. Auto Backlight Off If the meter backlight is idle for over 10 seconds, it will turn off automatically. 3. Manual Backlight Off To manually turn off the backlight, press and hold the main button for 4 seconds. 23

24 Easily Handling The McKesson Quintet AC Test Strip 1. Hold the test strip between thumb and middle finger with the indication symbol facing upright. 2. Put the forefinger on the side of the test strip as shown. NOTE This is the most effective way to insert the McKesson Quintet AC Test Strip. 3. Insert the test strip into the test strip port until it snaps firmly into place. 24

25 Easily Handling The McKesson Quintet AC Test Strip Removing the Test Strip 1. Hold the test strip in the same position as inserted. 2. Rotate the test strip counterclockwise and pull up at the same time. NOTE Pulling the test strip in a counterclockwise direction while lifting will easily remove the test strip from the meter. 3. Take the test strip completely out of the test strip port. Follow local regulations and discard the used test strip accordingly. NOTE If directions are followed properly, the Test Strip Port will not be contaminated by the sample. 25

26 Preparing for Testing Before Performing a Test Prepare the items below: McKesson Quintet AC Meter McKesson Quintet AC Test Strips (check the expiration date on the vial. Do not use expired test strips.) An Approved Lancing Device QUINTET AC Sterile Lancet Alcohol Swab (optional) Depth adjustable cap Release button Lancet carrier Safe switch Hub Plunger 26

27 Performing a Test in Order 1. Hold the adjustable cap in one hand and hold the hub in the other hand. Bend the cap towards the down side. When a gap appears between the cap and hub, pull them off in opposite directions. 2. Pull off the depth adjustable cap. 3. Insert a new disposable lancet firmly into the lancet carrier. 4. Twist off and set aside the protective cover of the disposable lancet. 5. Replace the depth adjustable cap. 6. Choose a depth of penetration by rotating the top portion of the depth adjustable cap until the setting depth matches the window. Settings are based on the skin type: for soft skin or thin skin; for average skin; for thick or calloused skin. 27

28 Performing a Test in Order 7. Hold the hub in one hand and pull on the plunger in the other hand. The device will be cocked. Release the plunger, it will automatically move back to its original position near the hub. 8. Use warm soapy water to wash hands. Warm water helps to increase the blood flow to the fingertips. An alcohol swab can also be used to clean the finger to get an accurate measurement. Dry thoroughly. 9. Remove a new test strip from the vial and re-cap the vial immediately. 10. Insert the test strip into the test strip port of the McKesson Quintet AC Meter with the indication symbol facing up. The meter confirms the insertion of the strip with a beep (if the volume is turned on). NOTE The McKesson Quintet AC Meter will automatically detect the code number on the test strip. There is no need for verification of the display code to the test strip vial. 28

29 Performing a Test in Order 11. The symbol will appear and will be accompanied by a beep that will sound (if the volume is turned on). The meter is now ready for testing (within 2 minutes). 12. Place the lancing device against your fingertip and press the release button. 13. Touch and hold the drop to the edge of the sample entry until you hear a beep (if the volume is turned on) and the View Window is totally filled with blood. If the View Window is not totally filled with blood or the test does not start, please discard the test strip and repeat the test with a new test strip. 14. You will see the countdown mode on the screen. After 5 seconds, the test result appears. 29

30 Performing a Test in Order 15. Pull off the depth adjustable cap from the lancing device. Without touching the used disposable lancet, stick the lancet tip into the protective cover. 16. Hold the release button of the lancing device in one hand (see picture 16, step 1) and pull on the plunger in the other hand (see picture 16, step 2) to safely eject the used disposable lancet. 17. Discard the used disposable lancet into an appropriate puncture-proof or biohazard container. 18. Replace the depth adjustable cap after finishing the test. 30 PRECAUTIONS Do not apply the sample to the sample entry before the appears. If the sample is applied before the meter has run the internal test, the screen will show and. Repeat the test with a new McKesson Quintet AC Test Strip. Record the date of opening in the allotted space on the test strips vial. Discard the vial of test strips 3 months after first opening. Do not use expired test strips.

31 Performing a Test in Order Alternative Site Testing - Palm or Forearm Blood Sampling Before performing alternative site testing, follow the directions on your alternative site lancing device. Install the clear cap on the lancing device. To increase the blood flow, massage the puncture area of the palm or forearm for a few seconds. Immediately after massaging the puncture area, press and hold the lancing device with the clear cap against the palm or forearm. Press the release button. Continue holding the lancing device against the palm or forearm and gradually increase pressure until the blood sample size is sufficient. Releasing button Pressing for a few seconds 31

32 Performing a Test in Order PRECAUTIONS The glucose test results of blood samples taken from an alternative site may vary under certain conditions. Glucose levels may change rapidly following a drink, meal, insulin dose or exercise. In this case, only fingertip samples should be tested. DO NOT test on the palm or forearm if testing for hypoglycemia (low blood glucose). Fingertip samples can show the rapid change of glucose faster than palm or forearm samples. Consult with a healthcare professional whenever conducting a test from the palm or forearm. As the blood flow taken from forearm is slower than fingertip or palm, use a special lancing device with Clear Cap for testing alternative sites. Do not use a normal lancing device for alternative site testing as the blood sample taken may not be enough for the meter. 32

33 Performing a Test in Order View Window Appearance Ensure the blood sample completely fills the View Window to get an accurate test result. An insufficient blood sample will result in an error message ( Er4 ). If this occurs, repeat the test with a new test strip. Insufficient Blood Sample Sufficient Blood Sample PRECAUTIONS Check the expiration date printed on the package with each use of the test strips. Do not use expired test strips. Use each test strip immediately after taking it out from the vial. Do not reuse test strips. If moving to a location with a different ambient temperature, wait at least 30 minutes before testing. 33

34 Comprehending Test Results and Messages Blood glucose test results are shown on the meter as mg/dl. If obtained blood glucose results are unusually high or low or results are of a questionable nature, repeat the test with a new test strip. If problems or questions persist, run a Quality Control Test with McKesson Quintet AC Control Solutions (Refer to page 39). If the test result still remains unusually high or low, contact a healthcare professional immediately. If experiencing symptoms that are not consistent with blood glucose test results, and directions have been followed properly, contact a healthcare professional immediately. 34

35 Comprehending Test Results and Messages The McKesson Quintet AC Meter displays results between 20 and 600 mg/dl. If the test result is below 20 mg/dl, will appear on the screen. Repeat the test again using a new test strip. If still appears as the test result, contact your healthcare professional immediately. If the test result is above 600 mg/dl, will appear on the screen. Repeat the test again using a new test strip. If still appears as the test result, contact your healthcare professional immediately. 35

36 Recalling Test Results and Average Test Results The McKesson Quintet AC Meter has the ability to store 500 test results with time and date. Once 500 test results are saved, which is the maximum memory of the meter, the newest test results will overwrite the oldest. To recall test memory, start the meter without a test strip inserted. 1. Press the main button to switch the screen to memory function. The MEM symbol will be displayed on the upper left corner of the screen. Use either the Left or Right button on the side to review all previous results with date and time. Results display from the most recent (Sequence no. 1 ) to the oldest (Sequence no. 500 ) at the lower right hand corner of the screen. 2. To finish reviewing memory tests, press the main button again to switch the screen to the average function. By pressing the right button, the display will show AVG on the upper right corner of the display and the average value for the actual day. On the average screen, use either the Left or Right button for the option of 1-day, 7-day, 14-day, 30-day, 60-day, or 90-day average of test results. The number shown on the lower right hand corner indicates how many test results have been calculated. 36

37 Recalling Test Results and Average Test Results 3. Non-Averaging set and canceled: After you finished your test in the test mode, you can exclude the unwanted result by pressing the right button until you see the NO AVG symbol on the top right corner of the screen. Keep the right button pressed and press the main button simultaneously to confirm the value as Non average. This value is now flagged by the symbol NO AVG in the upper right corner of the screen. To cancel this setting, stay in the test mode. Keep pressing the right button until the NO AVG symbol changes to AVG in the upper right corner of the screen. To confirm this original status, press the main button again to confirm the AVG status. The value will now be stored as a regular value and included in the average values. NOTE The average function is related to the time setting. You must set the time correctly and have enough time intervals on the basis of current inquiry time, to ensure that the average test results will show. Use the 14-day average for example; if your current inquiry time is 2011/1/30, then you must check that you have test blood glucose in the past 14 days before 1/30, including today. If not, the 14-day average will show no figure. The Non-averaging/re-averaging function only works in the test mode and when you get the value. In the MEM mode, you cannot perform this action. 37

38 Recalling Test Results and Average Test Results 4. Quick Searching: To see all values automatically displayed in sequence, first enter the memory mode, then press and hold down the Left or Right button for 2 seconds. (The Right button is for searching the tests from the most recent value to the oldest one, and the Left button is for searching the test from the oldest value to the most recent.) Release the pressed button to stop and it will display the current displayed value. 5. Reading immediately after test: Once finished with the test, press the main button to enter the MEM (memory) screen and review the most recent test result. NOTE The Control Solution results will be automatically non-averaged without selecting, but still can be recalled. The Control Solution Test results will show with symbol under the memory screen. 38 PRECAUTION Set the time and date to activate the average function. The and results, the Control Solution results, and the test results made out of normal temperature range 10 C - 40 C (50 F F) are not calculated in the average.

39 About Quality Control What is a Quality Control Test? To ensure proper monitoring function, it is necessary to perform a quality control test. When Should a Quality Control Test be Performed? Before executing a blood glucose test with the meter for the first time. When opening and using a new vial of test strips. When the meter is dropped or splashed with liquids. Whenever the test results are not consistent with symptoms. Whenever checking if the system is working properly. Whenever practicing testing and checking correct procedure. 39

40 About Quality Control Required Items for Quality Control Tests To perform a Quality Control Test, prepare the following items: McKesson Quintet AC Meter McKesson Quintet AC Test Strips Normal or High Level McKesson Quintet AC Control Solution QUINTET AC NOTE If you want to purchase new normal or high level McKesson Quintet AC Control Solution, please contact your authorized McKesson Quintet AC representative. 40

41 About Quality Control Example of Expiration Date: Exp. Date PRECAUTIONS When opening a new vial of McKesson Quintet AC Control Solution, write the discard date on the label. The discard date of McKesson Quintet AC Control Solution is 3 months after opening the vial, or the expiration date printed on the label, whichever comes first. Wipe the vial cap with a clean tissue before tightly capping the vial of control solution. Replace the vial cap of the control solution and close tightly immediately after using. Check the expiration date before use of the control solution. (see the Control Solution Package Insert) Keep Control Solution and vial out of reach of children. 41

42 Performing a Quality Control Test Performing a Test with the Control Solution 1. Remove a test strip from the vial and re-cap the vial cap immediately. 2. Insert the test strip with view window facing up, into the test strip port. 3. While the symbol is flashing, press and hold the main button for over 3 seconds until the symbol appears. 4. When you see the and symbols blinking on the screen, promptly apply the McKesson Quintet AC Control Solution. 5. Shake the vial of control solution well before opening the cap. Open the cap and set on a flat surface with the tip pointing up. OPEN Drip one drop of control solution on the top of the cap. 7. Gently touch the sample entry of the test strip with the control solution on the top of the cap. 8. When a beep is heard (if the volume is turned on), wait for the test result. The screen will show the countdown mode from 5.

43 LOT EXP Performing a Quality Control Test 9. Tightly recap the Control Solution. 10. The control result appears after the measurement is complete. Compare the control test result to the range printed on the test strip vial label. CLOSE 4 ml Level 2 (No Control Solutio Discard Date PRECAUTIONS The Quality Control Test result by the control solution test will not be calculated for average reading but still can be recalled. The Control Solution Test result will be shown with the symbol on the screen. The suggested environment for the Control Solution Test is 15ºC - 40ºC (59ºF - 104ºF). Do not apply the sample to the sample entry before the and appears. If the sample is applied before the meter has run the internal test, the screen will show and, accompanied by a beep that will sound if the volume is turned on. Do not drip the control solution from the vial to the sample entry directly (see drawing). The reagent may be sucked into the vial of control solution, which may cause alteration or degeneration. Doing this may contaminate the meter via the test strip port as well. Do not touch the top of the Control Solution bottle. If you have touched it, clean it with water. 43

44 Understanding Control Test Results Use the McKesson Quintet AC Control Solution to test with the McKesson Quintet AC Monitoring System under the Control Solution Mode. The control solution test results should fall within the control solution range. If the results are within normal range, the Quintet System is working correctly. Example of control solution range printed on the test strip vial label Control Solution Range mg/dl Normal: High: If control solution test results are out of control solution range, the McKesson Quintet AC System may not be working properly. Repeat the Quality Control Test. If the control solution results still fall outside of control solution range, do not use the McKesson Quintet AC System to test blood glucose. Contact a McKesson Quintet AC authorized representative or McKesson Brands Product Support Team. Possible reasons the control solution results are out of the range: The Control Solution has expired or has been open for a duration of over 3 months. The test strips have expired. Prolonged exposure of test strips or control solution due to the absence of the cap for an excessive time frame. Incorrect testing procedure followed. Malfunction of the meter.

45 Caring for the Meter Maintenance Keep the meter and test strip free of dust, water or any other liquid. Store the meter in the carrying case when not in use. If the meter is dropped or damaged, perform a quality control test with the control solution before doing a blood glucose test. Cleaning the Meter Clean the outside of the McKesson Quintet AC Meter with a damp cloth and mild soap/ detergent. Keep the test strip port from getting wet. Cleaning the Test Strip Port If your Test Strip Port is stained with blood, control solution or any liquid, please use a dry tissue or alcohol swab to clean it up immediately. Do not use anything wet to clean. Perform a quality control test to ensure the McKesson Quintet AC Meter is working properly. 45

46 Error Messages And Troubleshooting About Temperature Error 1. In order to get accurate testing, test between 10ºC - 40ºC (50ºF - 104ºF). 2. When the ambient temperature is 0ºC - 9ºC (32ºF - 48ºF) or 41ºC - 50ºC (106ºF - 122ºF), the warning symbol will blink. The test can still be performed, but the result obtained should only be for reference due to inconsistent test results under these ranges of temperature. Repeat the test in an area where the temperature is within the range 10ºC - 40ºC (50ºF - 104ºF). 2b 3. When moving from an area with temperature outside the operating range of the test strip to another area with temperature within the operating range of the test strip, wait for 30 minutes before testing. 4. When the temperature is below 0ºC (32ºF) or over 50ºC (122ºF), the meter cannot function and the symbol will blink. Move the meter to an environment with temperature between 10ºC - 40ºC (50ºF - 104ºF) and redo the test after waiting 30 minutes. 46

47 Error Messages And Troubleshooting About Battery Error 1. The symbol will blink when the battery power is low. The test can still be performed, but the batteries need to be changed as soon as possible. 2. The and symbols will blink when the battery is too low. The meter cannot function when the power is at this level. Change the batteries immediately. 3. After changing the batteries, perform the Quality Control Test. NOTE When the McKesson Quintet AC Meter s backlight has no function (you cannot see the backlight), please change your backlight battery. When the backlight battery is running out of power, the meter is still working properly, but without the backlight function. 47

48 Error Messages And Troubleshooting Sampling Error Do not apply the sample to the sample entry before the appears. If the sample is applied before the meter has run the internal test, the screen will show and, accompanied by a beep that will sound if the volume is turned on. Please discard the test strip and repeat the test with a new test strip. Er1 Test strip inserted has been used or damaged. Please use a new test strip from vial. Er2 Meter has malfunctioned. Do the Quality Control Test or reinstall the batteries to see if the meter works properly. If this error screen still appears, contact the McKesson Brands Product Support Team. 48

49 Error Messages And Troubleshooting Er3 While testing, the meter finds the signal is unreasonable or signal transmission is disrupted. Repeat the test. Er4 The applied blood volume is insufficient. Repeat the test with a new test strip. Meter Malfunction If the meter cannot be started, please follow the steps below: 1. Open the battery cover and remove the batteries. 2. Wait for 5 minutes and insert the batteries as described in the Battery Installation section, page 16. The meter should be working normally after finishing the above steps. If the meter does not work properly, please contact the McKesson Brands Product Support Team at

50 Limitations Store the McKesson Quintet AC Test Strips in the original capped vial at temperatures between 4 C to 30 C (39 F to 86 F) and relative humidity below 90%. Do not freeze. McKesson Quintet AC Test Strips are designed for use with capillary whole blood samples. Do not use serum or plasma samples. Inaccurate testing may result at high altitudes more than about 10,000 feet (3,048 meters) above sea level. Hematocrit below 30% may cause higher results, and hematocrit above 60% may cause lower results. Severe dehydration and excessive water loss may cause inaccurate, low results. The McKesson Quintet AC Monitoring System has not been validated for use on neonates. The glucose test may be interfered under abnormal concentrations of: Uric Acid 10.0 mg/dl, L-Dopa 3 mg/dl, Dopamine 2 mg/dl, Ascorbic acid (Vitamin C 5 mg/dl) 50 NOTE Acetaminophen, Ibuprofen, Methyldopa, Salicylic Acid, Tetracycline, Tolbutamide, Bilirubinconjugated, Cholesterol, Creatinine, Triglyceride, Maltose, Xylose, Galactose and Lactose (when occurring in normal blood or normal therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurate results. Sodium Fluoride/Potassium Oxalate at low glucose levels may result in inaccurate blood glucose reading. Sodium Fluoride/Potassium Oxalate should not be used as an anticoagulant with this device.

51 Specifications Measurement Technology Measurement Calibration Sample Minimum Sample Volume Measuring Range Test Time Memory Capacity Power Saving Operating Temperature Oxidase Electrochemical Sensor Plasma Capillary Whole Blood 0.75 microliter mg/dl 5 seconds 500 blood glucose test results with date and time Turn off automatically after meter is idle for 2 minutes after last action. Press the Main button for 4 seconds. 10ºC - 40ºC (50ºF - 104ºF) 51

52 Specifications Operating Relative Humidity 10-90% Hematocrit 30-60% Power Supply Battery Life Meter Dimension Meter Weight Monitor Display Area Meter Storage Conditions Test Strip Storage Conditions Two CR2032 batteries About 1,000 tests 90.6mm x 46mm x 16.5mm 53.0 ± 5g with batteries LCD Display 47mm x 33.5mm -10ºC - 60ºC (14ºF - 140ºF) 4ºC - 30ºC (39ºF - 86ºF) < 90% Relative Humidity 52

53 Warranty McKesson Medical-Surgical Inc. warrants that this McKesson Quintet AC Meter will be free from defects in materials and workmanship for five years from the date of purchase. This warranty does not apply to the performance of a McKesson Quintet AC Meter that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the meter. Please complete and return the enclosed warranty card to Bionime authorized representative. Different models have different specifications. Some of the models are not included with the warranty card. 53

54 Customer Service Review all of the instructions to ensure the steps are being performed correctly. General Questions? Call Technical Support? Call Distributed By McKesson Medical-Surgical Inc. Richmond, VA Rev /15 Made in Taiwan For in vitro diagnostic use Lot number Temperature limitation Manufacturer Use by Do not reuse Method of sterilization using irradiation 54

55 Expected Values For Normal Glucose Level Expected glucose values without diabetes: Status Range (mg/dl) Fasting From References 1) Diabetes Information - American Association for Clinical Chemistry (AACC) (Electronic Version). Retrieved March 24, 2010 from 55

56 Parts of Critical Component Meter, Test Strip, Control Solution, and Lancing Device Manufacturer: Bionime Corp. Disposable Sterile Lancets Manufacturer: SteriLance Medical (Suzhou) Inc. 56

57 Log Book Name: Address: Home Phone: Doctor: Pharmacy: Work Phone: Doctor s Phone: Pharmacy s Phone: Insulin/Pills: Log Book Date From: To: In case of emergency contact: 57

58 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 58

59 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 59

60 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 60

61 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 61

62 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 62

63 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 63

64 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 64

65 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 65

66 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 66

67 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 67

68 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 68

69 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 69

70 Log Book Date S M T W T F S Breakfast Lunch Dinner Bedtime Other Comments 70

71 Emergency Card Meter EMERGENCY INFORMATION User Name: User Phone No.: I am a diabetes patient. If you find me in a coma or stupor, please dial 911 Blood Type: Doctor/Hospital: * Please fill this card out and carry with you at all times. 71

72 General Questions? Call Technical Support? Call Distributed By McKesson Medical-Surgical Inc. Richmond, VA Rev / GM550-0W1 EN(US)