GLUCOCARD Shine User Manual - English
Contents
1. 5 5 100 5 5 100 4 5 80 3 5 60 48 www arkrayusa com 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 5 5 100 61 95 64 2 56 95 58 9 57 95 60 Within 10 95 95 100 91 95 95 8 87 95 91 6 86 95 90 5 87 95 91 6 Within 15 95 95 100 94 95 98 9 93 95 97 9 86 95 90 5 93 95 97 9 Alternative site test results for glucose concentration 75 mg dL Within 5 95 95 100 69 95 72 6 Within 20 95 95 100 95 95 100 95 95 100 95 95 100 95 95 100 www arkrayusa com 49 Warranty Information Manufacturer s Warranty ARKRAY USA Inc warrants that the GLUCOCARD Shine Meter Shall be free of defects in material and workmanship in normal use for a period of five 5 years The meter must have been subjected to normal use The warranty does not cover improper handling tampering use or service of the meter Any claim must be made within the warranty period The ARKRAY USA Inc company will at its discretion repair or replace a defective meter or meter part that is covered by this warranty As a matter of warranty policy ARKRAY USA Inc will not reimburse the consumer s purchase price Obtaining Warranty Service To obtain warranty service you must return the defective meter or meter part along with proof of purchase to ARKRAY USA Inc 50 ww2. e When the color of the meter or lancing device has changed or faded e When cracks or roughness develop on the meter or lancing device e When a part of the segment on the meter display does not flash e When control solution test results do not fall within the stated range on the test strip vial 42 www arkrayusa com Caution e Do Not use other cleaners or disinfectants because other chemicals have not been validated and may damage the meter e Do Not get fluids inside the meter through the test strip port data transmission port or battery compartment Never immerse the meter or hold it under running water because this will damage the meter Caution Storage and Handling e Do not expose the meter to direct sunlight or heat for extended periods of time e Do not let dirt dust blood or water enter into the meter s test Strip port e Do not drop the meter or subject it to strong shocks e Do not try to fix or alter the meter in any way e Keep the meter in a cool and airy place e Keep the meter away from strong electromagnetic field sources such as cell phones and microwave ovens e The GLUCOCARD Shine Meter should be used only with GLUCOCARD Shine Test Strips e Store all meter components in the carrying case to prevent loss Note You can get additional information or technical assistance by calling our Customer Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada www ark
3. Removing the meter batteries will not affect your stored result However you may need to reset your meter settings See pages 13 17 8 www arkrayusa com GLUCOCARD Shine Blood Glucose Test Strip The GLUCOCARD Shine Blood Glucose Monitoring System measures blood glucose quickly and accurately It automatically absorbs the small blood sample applied to the narrow edge of the strip TT E Contact bars Gently push the test strip with its A contact bars facing up into the test strip port of meter REeJHJe Confirmation window Check here to see whether sufficient blood sample has been applied Edge to apply blood sample To Apply blood sample here for testing Important Safety Instruction e All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases even after disinfection e Do not share your meter or lancing device with another person Insert www arkrayusa com 9 e The GLUCOCARD Shine Test Strip should be used only with fresh capillary whole blood samples e Do not reuse test strips e Do not use GLUCOCARD Shine Test Strips beyond the expiration date This may cause Inaccurate results e Test strips in new unopened vials and test strips in vials that have been opened can be used until the expiration date printed on the test strip box and vial label if the test strips are used and stored according to Its storage and handling meth
4. Step 1 Press the lt lt or gt gt button to turn the meter on The current date and time will be displayed on the bottom of the screen for 2 seconds followed by the 1 day average value and the number of the test The number of results saved within the current day tests Step 2 Viewing Averages Press the lt lt to view 14 30 and 90 day average values and the number of tests performed for the last test period lt lt button Average 1 7 14 30 90 days o gt gt button 34 www arkrayusa com Step 3 Viewing Pre meal Averages Repeatedly press the lt lt to view 1 7 14 30 and 90 day average value and the number of tests performed pre meals with the Pr symbol for the last test period lt lt button lt a Pre meal average 1 7 14 30 90 days 1 gt gt button Step 4 Viewing Post meal Averages On pressing the lt lt again 1 7 14 30 and 90 day average value and the number of tests performed post meals for the last test period will appear on the screen Hold the gt gt button to turn off the meter lt lt button p gt Post meal average 1 7 14 30 90 days area 1 ss A gt gt button 9 m7 mgt Use the gt gt button to scroll back through the averages seen previously www arkrayusa com 35 Viewing Test Results Step 1 Press lt lt or the gt gt button to turn the meter on The current date and time will
5. See the pre cleaning and disinfection section on page 40 Note Repeated puncturing at the same sample site may cause pain or skin calluses thick hard skin Choose a different site each time you test 22 www arkrayusa com Preparing the Lancing Device Step 1 Wash hands and the site from where the blood sample will be drawn thoroughly with warm soapy water Rinse and dry Step 2 Unscrew and remove the adjustable tip Step 3 Insert a new disposable lancet firmly into the lancet holder Twist off the protective cover of the lancet and set it aside then replace the adjustable tip Keep the protective cover to replace on top of the used lancet after testing www arkrayusa com 23 Step 4 The lancing device has five puncture depth settings numbered 1 through 5 The smaller numbers are for a shallowerpuncture and the larger numbers are for a deeper puncture Choose a depth of penetration by rotating the top portion of the adjustable tip until the setting number matches the arrow Step 5 Cock the lancing device by holding the body in one hand and pulling on the g sleeve with the other hand until the dor device clicks e A A UNA Note The skin depth to retrieve samples will vary for various people at different sample sites The lancing device s adjustable tip allows the best depth of skin penetration for an adequate sample size A beginning setting of three 3 Is recommended 2
6. a new opened plus three 3 months bottle of control e When the control solution is contaminated solution Caution If results continue to fall outside the range printed on the test strip vial the Test Strip and Meter may not be working properly Do not use your system and contact Customer Service 800 566 8558 Note The GLUCOCARD Shine Control Solution can be purchased separately Contact Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada www arkrayusa com 21 Using the Lancing Device You will need a lancing device in order to collect a blood sample You may use the lancing device contained in the GLUCOCARD Shine Blood Glucose Monitoring System or any other medically approved lancing device Adjustable Tip Lancet Holder Ejection System gt Lancet Release Button Sliding Barrel e The lancing device is for use by a single user only and should not be shared with anyone including other family members CAUTION To reduce the chance of infection e All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases even after disinfection e Do not use a lancet that has been used by another person and never share your meter and lancing device with anyone e Wash your hands thoroughly with soap and water after handling your meter lancing device or test strips e Keep your meter and lancing device clean
7. the kit are considered biohazardous and can potentially transmit infectious diseases even after you have performed pre cleaning and disinfection The GLUCOCARD Shine Blood Glucose Monitoring System is information about this waiver visit the FDA website at http www accessdata fda gov scripts cdrh cfdocs cfclia search cfm www arkrayusa com 5 e For questions or concerns contact Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada At all other times or in case of emergency please contact your healthcare professional or emergency medical response Specifications e Product specifications Measurement range 20 600 mg dL Sample size Minimum 0 5 uL Test time 5 seconds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 1 000 tests Power Two 3 0 V lithium batteries disposable type CR2032 Memory 500 test results Size 3 74 x 1 30 x 0 75 in Weight 1 45 oz with batteries e Operating ranges Relative humidity 10 90 Hematocrit 20 60 6 www arkrayusa com GLUCOCARD Shine Blood Glucose Monitoring System Components GLUCOCARD Shine BGM System includes the following items GLUCOCARD Shine Blood Glucose Meter User s Manual Quick Reference Guide Batteries GLUCOCARD Shine BGM System may include the following items GLUCOCARD Shine Blood Glucose Test Strips Lancing Devi
8. the memory check mode without the alarm being displayed alarm vanishes www arkrayusa com 37 Setting the Strip Expiration Date Indicator The test strip expiration date indicator can be set in the GLUCOCARD Shine meter The strip expiration date is printed on the test strip vial At any stage if the gt gt button is pressed for 3 seconds the meter will be turned off To turn on the indicator function see page 16 to view how to turn on the indicator Step 1 Enter the Expiration Date Setting Press and hold the lt lt and gt gt button at the same time for 3 seconds to enter the expiration date settings After all segments flash across the screen EP will be displayed on the screen Press the gt gt button to change the date Note The strip expiration date is printed on the test strip vial Step 2 Setting the Year A number indicating the year will blink in the left corner of the screen Press the lt lt button until the correct year fi appears Press the gt gt button to confirm the year and set the month wlio Step 3 Setting the Month A number indicating the month will blink in the left corner of the screen Press the lt lt button until the correct month appears After finishing the setting press and hold the gt gt button for 3 seconds to turn off the meter ele ore 38 www arkrayusa com Caring for Your System e To minimize the risk of transmission of blood
9. 4 www arkrayusa com Preparing the Meter and Test Strip Step 6 With the contact bars facing up insert a test strip into the meter s test strip port Push the strip gently into the strip port until the power automatically turns on and the 4 symbol appears Flagging Post meal Test Results The GLUCOCARD Shine Meter allows you to flag a result of a post meal test with 4 symbol The post meal test flag ff can be attached just before applying the blood sample Once you attach the post meal flag 1 to the test results it cannot be deleted Step 7 If you want to attach a post meal flag 71 to a test result press and hold lt lt wa for 3 seconds after inserting the test ey strip The post meal flag ff and the 4 oka symbol will appear on the screen The test result will also be displayed with the post meal flag ff If you do not want to save the result as a post meal test move on to the step 8 after the step 6 www arkrayusa com 25 Applying the Blood Sample Step 8 Obtain a blood sample using the lancing device Place the device against the pad of the finger The best puncture sites are on the middle or ring fingers Press the release button Remove the device from the finger Wait a few seconds for a blood drop to form A minimum volume of 0 5 microliter is needed to fill the confirmation window Step 9 After the symbol appears on the screen apply the blood sample to the narrow end of the tes
10. D Shine Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly 4 www arkrayusa com Important Health Related Information e The GLUCOCARD Shine Blood Glucose Monitoring System is intended for in vitro outside the body diagnostic use only and for the quantitative measurement of glucose in capillary whole blood e The GLUCOCARD Shine Blood Glucose Monitoring System is intended for use by a single user only Do not share the meter and lancing device with another person e The GLUCOCARD Shine Blood Glucose Meter is designed to minimize code related errors in monitoring by using the no coding function e The glucose in the blood sample mixes with special chemicals on the test strip to produce a small electrical current The GLUCOCARD Shine Meter converts this electrical current to glucose concentration e The GLUCOCARD Shine Blood Glucose Meter should be used only with the GLUCOCARD Shine Test Strip e An abnormally high or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results e Inaccurate results may occur in severely hypotensive having low blood pressure individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic high blood sugar or hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters e All parts of
11. GLUCOCARD ao Shine Control Solution ranges printed on their labels Compare the result displayed on the meter to the GLUCOCARD Shine Control Solution range printed on the test strip vial Before using a new meter or a new vial of test strips you should conduct a control solution test following the procedure on pages 19 20 with two different levels of solutions Control Level 1 and 2 Notes e GLUCOCARD Shine Meter and GLUCOCARD Shine Test Strips only can be used with GLUCOCARD Shine Control Solutions e Check the expiration dates printed on the bottle When you first open a control solution bottle record the discard date date opened plus three 3 months in the space provided on the label e Make sure your meter test strips and control solutions are at room temperature before testing Control solution tests must be done at room temperature 68 77 F 20 25 C e Before using the control solution shake the bottle discard the first 1 or 2 drops and wipe the tip clean e Close the control solution bottle tightly and store at a temperature of 46 86 F 8 30 You should do a control solution test e When you want to practice the test procedure using the control solution instead of blood e When using the meter for the first time 18 www arkrayusa com e Whenever you open a new vial of test strips e f the meter or test strips do not function properly e f your symptoms are inconsistent with the blood glucose
12. Glucose Meter Display Q PS a om EIN ar O 1 Test results test results displaying panel 2 Battery symbol indicates meter battery is running low and needs to be replaced 3 mem appears when test results stored in the memory are displayed 4 alarm appears when the post meal alarm has been set 5 check appears when test results have not been saved 6 Hypoglycemia symbol appears when the test result is below the hypoglycemic level 7 Mute symbol appears only when the sound is set to OFF Post meal test flag appears during post meal testing and when post meal test results are displayed Month Day Hour Minute 40 Temperature symbol displays recorded temperature when blood glucose levels are tested 17 Blood insertion symbol indicates meter is ready for the application of a drop of blood or control solution 2 Decimal point appears when the blood glucose measuring unit is set to mmol L 43 mg dL mmol L unit for measuring blood glucose Note The unit of measurement is fixed in mg dL and it cannot be changed to mmol L by the user 12 www arkrayusa com Setting up Your System Press and hold the gt gt button for 3 seconds to enter the set mode After all settings are finished press and hold the gt gt button for 3 seconds to turn off the meter Press lt lt to reach the accurate value Press and hold lt lt to scroll faster Adjusting the Date and Time Step 1 Entering the
13. SET Mode Press and hold the gt gt button for 3 seconds to enter the set mode After all the segments flash across the screen SET is displayed on the screen Press the gt gt button again to set the year Step 2 Setting the Year Press and release lt lt to adjust until the correct year appears After setting the year press the gt gt button to confirm your selection and set the month Step 3 Setting the Month A number indicating the month will blink on the left corner of the screen Press lt lt until the correct month appears Press the gt gt button to confirm your selection and set the day www arkrayusa com 13 Step 4 Setting the Date Press lt lt until the screen displays the correct day Press the gt gt button to confirm the date and set the time Step 5 Setting the Time Format The meter can be set in the AM PM 12 hour or the 24 hour clock format Press lt lt to select a format AM PM is not displayed in the 24 hour format After selecting the format press the gt gt button to set the hour Step 6 Setting the Hour Press lt lt until the correct hour appears After the hour is set press the gt gt button to set the minute Step 7 Setting the Minute Press lt lt until the correct minute appears After setting the minute press the gt gt button to set the sound 14 www arkrayusa com Setting the Sound On OFF Step 8 On pressing lt lt
14. a gt A ER 1 x 0 a e 1 1 1 1 E 1 a 1 a 1 sf eA if Q E 2 y A cy x kd s g e e s s A l Back Both sides 3 Dispose of the used towelette in a trash bin 4 Pull out 1 new towelette and wipe the entire surface of the meter 3 times horizontally and 3 times vertically using a new towelette to remove blood borne pathogens Clorox Germicidal N Dispose of the used towelette in a trash bin 6 Allow exteriors to remain wet for 1 minute then wipe the meter using a dry cloth dry cloth J minute m www arkrayusa com 41 7 Repeat the same procedure for the F n lancing device step to step fes After the pre cleaning and disinfection procedure the control solution should be tested to confirm that the meter works properly before using the meter Control solution tests should be performed with two different levels of solutions Control Level 1 and 2 Verify that the test results are within the range printed on the test strip vial See pages 19 20 for how to do a control solution test Note If any of the following deterioration signs appear after pre cleaning or disinfecting please stop using the system and contact Customer Service 800 566 8558 24 hours a day days a week US and Canada e When the inscriptions on the exterior of the meter or lancing device have been removed
15. alternative sites differs from person to person e Before using AST please consult your healthcare professional Note Results from alternative site and fingertip samples may differ from each other as there is a time lag for the glucose levels to reach the same value Use a fingertip sample if you suffer from hypoglycemia or have experienced hypoglycemic shock or symptoms Note If the sample drop of blood runs or spreads due to contact with hair or with a line in your palm do not use that sample Try puncturing again in a smoother area www arkrayusa com 31 HI and Lo Messages HI Message The meter displays results between 20 600 mg dL HI appears when the blood glucose level is greater than 600 mg dL and indicates severe hyperglycemia much higher than normal glucose levels If HI is displayed again on retesting please contact your healthcare professional immediately Lo Message Lo appears when the result is less than 20 mg dL and indicates severe hypoglycemia very low glucose levels If Lo is displayed again on retesting please contact your healthcare professional immediately When the hypoglycemia indicator is on A symbol also appears Note If messages for hyperglycemia or hypoglycemia are displayed even if you do not have those conditions please contact Customer Service 800 566 8558 24 hours a day days a week US and Canada 32 www arkrayusa com Target Bloo
16. and optimum system benefits please read the entire manual contents before using the system Please note the following instructions e Do not use the system for the diagnosis or screening of diabetes e Use only fresh capillary whole blood samples for testing e Alternative site and fingertip test results may differ significantly due to rapid changes in the glucose level after eating insulin Injection or exercise Intended use The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm palm thigh and calf Alternative site testing should be used only during steady State blood glucose conditions The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body in vitro by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The system is intended to be used by a single person and should not be shared It is not intended for use on neonates and is not for the diagnosis or screening of diabetes The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites The GLUCOCARD Shine Control Solutions are for use with the GLUCOCARD Shine Meter and GLUCOCAR
17. be displayed on the bottom of the screen for 2 seconds followed by the gt 1 day average value and the number of The number of the test results saved within the current tests day Step 2 Use the gt gt button to scroll through the test results starting from the most recent and ending with the oldest Press the lt lt to return to the result seen previously The test date and the recorded temperature will display alternately After checking the stored test result hold the gt gt button to turn off the meter mem gt gt button gt lt lt button 36 www arkrayusa com Setting the Post meal Alarm PP2 Alarm The PP2 alarm goes off 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by pressing lt lt or the gt gt button or by inserting a test strip Step 1 Setting the PP2 alarm On Without inserting a test strip press and hold lt lt for 3 seconds to set the post meal alarm The PP2 the alarm and then the On will be displayed The screen will then automatically change to the memory check mode At this time the alarm indicating that the PP2 alarm has been set will be displayed on the screen a PR Mr 0 vs belts te PM Step 2 Setting the PP2 alarm OFF To turn off the PP2 alarm press and hold lt lt for 3 seconds The PP2 and the OFF will appear on the screen Then the screen will change automatically to
18. borne pathogens the pre cleaning and disinfection procedure should be performed as recommended in the instructions below e Wash your hands thoroughly with soap and water after handling the meter lancing device or test strips e f the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be disinfected prior to use by the second person Pre cleaning and Disinfection The pre cleaning procedure is needed to clean dirt as well as blood and other body fluids on the exterior of the meter and lancing device before performing the disinfection procedure The disinfection procedure is needed to prevent transmission of blood borne pathogens e For the meter and lancing device this pre cleaning and disinfection procedure should be performed once per week Note The life span of a GLUCOCARD Shine meter is 5 years We recommend disinfecting both the meter and lancing device at least once per week We have validated a total of 260 cleaning and disinfecting cycles 260 pre cleaning and 260 disinfection cycles to represent weekly cleaning and disinfecting over the use life of your meter and lancing device 1 pre cleaning and 1 disinfection cycles per week 52 weeks per year 5 years 260 pre cleaning and 260 disinfection cycles www arkrayusa com 39 e We have validated Clorox Germicidal Wipes with 0 55 sodium hypochlorite as the active ingredient for disinfec
19. ce Caution The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly 28 www arkrayusa com Alternative Site Testing What is AST Alternative Site Testing Usually when someone tests their glucose they take the blood sample from the tip of the finger However since there are many nerve endings distributed there It can be quite painful When doing a glucose test using different parts of the body such as the forearms palms thighs and calves can reduce the pain during testing This method of testing with different parts of the body is called Alternative Site Testing While AST may reduce the pain during testing it may not be simple for everyone and the following precautions should be observed during testing Alternative Sites for Testing a Alternative Site Blood Sampling forearm palm thigh calf Select a clean soft and fleshy sample site area free of visible veins and hair and away from bones Gently massage the sample site to help blood circulation to minimize result differences between fingertip and alternative site sampling Firmly press and hold the lancing device against site Wait until the skin surface under the lancing device changes color Then press the release button while continuing to apply pressure Keep holding the lancing device against your skin until sufficient at least 0 5 uL blood is drawn Carefully lift the lancing device away from yo
20. ce Lancets Logbook Carrying Case e Check all the components after opening the GLUCOCARD Shine Blood Glucose Monitoring System package e The GLUCOCARD Shine Control Solutions Level 1 and 2 are necessary but not included The GLUCOCARD Shine Control Solutions and the cable for the data transmission to a PC can be ordered separately Please contact Customer Service 800 566 8558 24 hours a day days a week US and Canada Caution The meter and lancing device are only intended for a single user Do not share them with anyone including other family members Never use on multiple users www arkrayusa com 7 Inserting or Replacing the Batteries The GLUCOCARD Shine Meter uses two 3 0 V lithium batteries Before using the meter check the battery compartment and insert batteries if empty When the symbol appears on the display for the first time the batteries should be replaced as soon as possible The test results might not be saved if the batteries run out Step 1 Make sure the meter is turned off Press down and slide off the battery compartment cover Step 2 Remove the used batteries one at a time Slip your index finger under the battery to lift and pull out as shown Insert two new batteries with the side facing up and make sure the batteries are inserted firmly in place Step 3 Place the cover on the battery compartment Push down until you hear the tab click into place Note
21. d the result is not stored in the meter s memory and is not included in the averages Step 4 Compare the result displayed on the E E lt 1 meter to the range printed on the test ndo Ceni strip vial The result should fall within that Level 1 101 151 majdL range Used strips should be discarded E o safely in disposable containers Caution The ranges printed on the test strip vial are for the GLUCOCARD Shine Control Solutions only They do not have any connection to your blood glucose level 20 www arkrayusa com Comparing the Control Solution Test Results The test result of each control solution should be within the range printed on the label of test strip vial Repeat the control solution test if the test result falls outside of this range Out of range results may occur due to the following factors e When the control solution bottle was not Repeat the Shaken well control solution e When the meter test strip or the control test by referring solution were exposed to high or low to the Notes temperatures on page 18 e When the first drop of the control solution was not discarded or the tip of the bottle was not wiped clean e When the meter is not functioning properly e When the control solution is past the Discard the used expiration date printed on the bottle control solution e When the control solution is past its and repeat the discard date the date the bottle was test using
22. d Glucose Ranges Reminders Your target ranges Time of day from your healthcare professional Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a m and 4 a m Expected Values The range of a normal fasting blood glucose level for non diabetic adults is between 70 99 mg dL Two 2 hours after a meal the range of a normal blood glucose level for non diabetic adults is between 100 139 mg dL Fasting is defined as no caloric intake for at least eight 8 hours Reference American Diabetes Association Standards of Medical Care in Diabetes 2012 Diabetes Care January 2012 35 1 S11 S63 Transferring Test Results Test results stored in GLUCOCARD Shine meter can be transferred from the meter to a computer using PC care software and cable The Pc is displayed when the data cable connects the meter with computer For more information contact Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada www arkrayusa com 33 Meter Memory The GLUCOCARD Shine meter can save up to 500 glucose test results with time and date If the memory Is full the oldest test result will be deleted and the latest test result will be stored The GLUCOCARD Shine meter calculates and displays the averages of total test results pre meal test Pr results and post meal test ff results from the last 1 7 14 30 and 90 days Viewing Averages
23. er Service 800 566 8558 24 hours a day 7 days a week US and Canada www arkrayusa com 45 General Troubleshooting Problem Troubleshooting The display is blank even after inserting a test strip Check whether the test strip Is inserted with the contact bars facing up Check if the strip has been inserted completely into the test strip port Check if the appropriate test strip was used Check whether the batteries are inserted with the side facing up Replace the batteries The test does not Start even after applying the blood sample on the strip Check if the confirmation window is filled completely Repeat the test after inserting a new test strip The test result doesn t match the way you feel Repeat the test after inserting a new test strip Check the expiration date of the test strip Check the meter Note If the problem is not resolved please contact Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada 46 www arkrayusa com Performance Characteristics The performance of GLUCOCARD Shine Blood Glucose Monitoring System has been evaluated in laboratory and clinical tests ACCURACY The GLUCOCARD Shine BGM System is calibrated to yield results equivalent to plasma glucose concentrations The accuracy of the GLUCOCARD Shine System was tested by comparing blood glucose results obtained by patients with those obtained using a YSI M
24. hypoglycemia indicator possible low blood sugar on or off and to select the desired level for the indicator You will be alerted any time your test result is lower than the selected level When Hypo ts displayed along with the hypoglycemia symbol N press lt lt The screen will display On or OFF Press the gt gt button when On appears to set the desired level Then press lt lt until the desired hypoglycemic level between 20 and 60 mg dL is being displayed Then press the gt gt button to confirm the level If you do not want to set the indicator press the gt gt button while the screen displays no The screen will then return to step 2 See page 13 When you are done setting all the modes turn the meter off by pressing and holding the gt gt button for 3 seconds Note If the test result is lower than the pre set hypoglycemia level the meter will display the following Caution Before the HYPo indicator is set ask your doctor or diabetes nurse to help you decide what your hypoglycemia level will be www arkrayusa com 17 Checking the System You should check your meter and test strips using the GLUCOCARD Shine Control Solutions Control Level mi 1 and 2 The GLUCOCARD Shine Control Solutions INI contain known amounts of glucose and are used to tucocaro snne Check that the meter and the test strips are working E properly The test strip vials have
25. oOfKfady GLUCOCARD fe Shine BLOOD GLUCOSE MONITORING SYSTEM oO em E m ce lt a O UO l O User Manual For single user home use only Table of Contents Information Important Information Read this First Important Health Related Information Specifications GLUCOCARD Shine Blood Glucose Monitoring System Inserting or Replacing the Batteries GLUCOCARD Shine Blood Glucose Test Strip GLUCOCARD Shine Blood Glucose Meter GLUCOCARD Shine Blood Glucose Meter Display Preparation Setting up Your System Adjusting the Date and Time Setting the Sound On OFF Turn on the Strip Expiration Date Indicator Turn on the Hypoglycemia HYPo Indicator Checking the System Control Solution Testing Comparing the Control Solution Test Results Testing Using the Lancing Device Preparing the Lancing Device Preparing the Meter and Test Strip Flagging Post meal Test Results Applying Blood Sample Discarding Used Lancets Alternative Site Testing HI and Lo Messages Target Blood Glucose Ranges Transferring Test Results Additional Functions Meter Memory Viewing Averages Viewing Test Results Setting the Post meal Alarm PP2 alarm Setting the Strip Expiration Date Indicator Maintenance Caring for Your System Understanding Error and Other Messages General Troubleshooting Performance Characteristics Warranty Information NM OOND OFS Important Information Read this First To receive safe
26. odel 2300 Glucose Analyzer a lab instrument The results below were obtained by diabetic patients at clinic centers Obtained by healthcare Obtained by professionals lay users Slope 1 023 1 006 Y intercept 2 07 mg dL 0 41 mg dL Correlation coefficient r 0 996 0 994 Number of sample 100 100 Range tested 66 321 mg dL 66 321 mg dL Accuracy results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 5 5 100 5 5 100 5 5 100 Accuracy results for glucose concentration 75 mg dL Within 5 Within 10 Within 15 Within 20 79 95 83 2 94 95 98 9 95 95 100 95 95 100 www arkrayusa com 47 Precision Precision studies were performed in a laboratory using the GLUCOCARD Shine System Within Run Precision Bloodavg Bloodavg Bloodavg Bloodavg Bloodavg 39 mg dL 82 mg dL 145 mg dL 179 mg dL 341 mg dL SD 1 9 mg dL SD 2 7 mg dL CV 2 9 CV 3 9 CV 2 5 Total Precision Controlavg Controlavg Controlavg 32 mg dL 121 mg dL 354 mg dL SD 1 7 mg dL CV 3 6 CV 4 3 This study shows that there could be variation of up to 4 3 Alternative Sites Testing Evaluation e Comparison of results using various AST sites with the results of YSI measurements Alternative site test results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 5 5 100
27. ods e Store test strips in a cool and dry place at a temperature of 34 86 F 1 30 C e Keep test strips away from direct sunlight or heat and do not freeze e Store test strips only in their original vial e Close the vial tightly after taking out a test strip and use the test strip immediately e Handle test strips only with clean dry hands e Do not bend cut or alter test strips In any way e For detailed storage and usage information refer to the GLUCOCARD Shine Test Strip package insert e Keep the meter and testing supplies away from young children Note You can get more safety information at FDA Public Health Notification http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm or at CDC Clinical Reminder http Awww cdc gov injectionsafety Fingerstick DevicesBGM html 10 www arkrayusa com GLUCOCARD Shine Blood Glucose Meter Display Shows results messages Test Strip Port Insert test strip here gt gt Button Turns the meter on off confirms menu selections and changes information GLUCOCARD Shine DIA DA a aterm CN al aeee ATN ie IOA lt lt Button Turns the meter on selects Data Port of chan Used to transfer data ges f th ter t information PONT TNE Meter O a computer with a cable Note The cable for data transmission to a PC can be ordered separately Please contact Customer Service 800 566 8558 www arkrayusa com 11 GLUCOCARD Shine Blood
28. rayusa com 43 Understanding Error and Other Messages A used test strip was Inserted gt Remove the strip and reinsert a new test strip The blood or control solution sample was applied before the 4 symbol appeared gt Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control solution sample The blood sample has abnormally high viscosity or insufficient volume gt Repeat the test using a new test strip This error message may appear when the wrong blood glucose test strip Is used instead of GLUCOCARD Shine blood glucose test strip gt Repeat the test with a GLUCOCARD Shine test strip There is a problem with the meter gt Do not use the meter Contact Customer Service at 800 566 8559 24 hours a day days a week US and Canada 44 www arkrayusa com The temperature during the test was above the operating range gt Move to an area where the temperature is within the operating range 10 40 C 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range The temperature during the test was below the operating range gt Move to an area where the temperature is within the operating range 10 40 C 50 104 F and repeat the test after the meter and test strips have reached a temperature within the operating range Note If the error messages persist please contact Custom
29. t strip until the meter beeps If the blood sample does not fill the confirmation window completely an Er4 message may appear because of abnormal viscosity or insufficient volume If an Er4 message appears retest with a new test strip Approximate size Good Insufficient Sample Sample 26 www arkrayusa com Note The meter will switch off if the blood sample is not applied within 2 minutes of the amp symbol appearing on the screen If the meter turns off remove the strip reinsert It and apply the blood sample after amp symbol appears on the screen Step 10 The test result will appear after the meter counts down from 5 to 1 The result will be automatically stored in the meter s memory If the test strip is removed after the test result is displayed the meter will automatically switch off after 3 seconds Discard used test strip safely in a disposable container www arkrayusa com 27 Discarding Used Lancets Step 1 Unscrew the lancing device tip Step 2 Place the protective cover on the lancet Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard VAN container A Caution e Check for damages before using the lancet If they have been damaged please discard it and use other lancet e The lancet is very sharp Please keep away from children e Keep the lancets in a cool and dry pla
30. test results and you feel that the meter or test strips are not working properly e f you drop or damage the meter e When using the meter for blood glucose test after any disinfection procedure Control Solution Testing Step 1 Insert a test strip into the meter s test strip port with the contact bars facing upwards Gently push the test strip into the test strip port until the meter beeps Be careful not to bend the strip while pushing it in The amp symbol will be displayed on the screen Step 2 Shake the GLUCOCARD Shine ae j e Control Solution bottle before each test Remove the cap and squeeze the bottle to discard the first 1 or 2 ih oq drops TTA ee Then wipe the tip with a clean tissue or cloth After the amp symbol appears on the display apply the solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window fills completely www arkrayusa com 19 Note The meter will switch off if the control solution sample is not applied within 2 minutes of the amp symbol appearing on the screen If the meter turns off remove the strip reinsert and start from step 1 Step 3 A test result will appear after the meter counts down from 5 to 1 GLUCOCARD Shine After your control solution result ds HE q4 check appears on the display press lt lt for 3 seconds until the check symbol appears on the display When the check symbol is displaye
31. the screen will display the On or OFF Press the gt gt button to confirm the selection and move to the next mode The meter will beep in the following instances If set to On When you push the gt gt button or lt lt button to turn on the meter When the test strip Is Inserted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When you push the lt lt button to set the post meal PP2 alarm When it is time for a preset blood glucose test If the sound is set to OFF none of the sound functions will work Note When the sound is set to OFF the A symbol appears on the display www arkrayusa com 15 Turn on the Strip Expiration Date Indicator Step 9 This mode allows you to turn the Strip expiration date indicator on or off When EP blinks on the screen press lt lt The screen will display On or OFF Press the gt gt button to confirm the setting and move to the next mode This mode turns the function on or off only See page 38 to set the strip expiration date Note If the pre set expiration date expires the meter will display the following For example in the case when the expiration date Is set to October of 2014 the meter displays EP at the start of November of 2014 16 www arkrayusa com Turn on the Hypoglycemia HYPo Indicator Step 10 This mode allows you to turn the
32. ting the GLUCOCARD Shine Meter and lancing device It has been shown to be safe for use with the meter and lancing device This disinfectant is available commercially in towelette form In addition to GLUCOCARD Shine BGMS instruction please read the instructions provided by the manufacturer of Clorox Germicidal Wipes before using it Name Clorox Germicidal Wipes Clorox Professional Products Company Manufacturer Phone 1 800 537 1415 Website www cloroxprofessional com EPA registration 67619 12 number Active ingredients Sodium Hypochlorite 0 55 Note The disinfectant products can be purchased online retailers e g Amazon or by telephone at the manufacturer To find out where to purchase the disinfectant product please contact the manufacturer or visit their website as listed above Pre cleaning and Disinfection Procedures 1 Open the cap of the Clorox Germicidal Wipes container and pull out 1 towelette Clorox Germicidal and close the cap Wipes 40 www arkrayusa com 2 Wipe the entire surface of the meter 3 times horizontally and 3 times vertically using one towelette to pre clean blood and other body fluids Eq e pq x s P s ll CID Ls N e j s s 1 7 A s a 1 z a 1 E a D 1 E s r s 1 a a 1 1 1 1 a a 1 0 1 O 1 a a Q r a A 1 i 1 i a 1 a 1 a 1 T 2 h 1 I I I i 1 E r a ke e 1 F E
33. ur skin fica Ts un NES A www arkrayusa com 29 Caution AST results should never be used to calibrate Continuous Glucose Monitoring Systems nor entered into an insulin dosing calculator or pump for dosing recommendations Things to know when using AST Please understand the following before testing at sites other than the fingertip forearms palms thighs and calves The capillary whole blood of the fingertips shows changes in glucose levels more rapidly than from alternative sites Therefore the test results from the fingertip testing and AST may differ This is because things such as lifestyle and ingested food having an effect on glucose levels e Fasting period e Before a meal e When the glucose levels are rapidly increasing such as during the two 2 hours after a meal or exercise e When sick or when glucose levels seem quite lower than test value e When hypoglycemia is not well recognized e When insulin has the biggest effect e Two 2 hours after an insulin injection 30 www arkrayusa com AST Precautions e Do not ignore the symptoms of hyperglycemia or hypoglycemia e When the results of the test do not reflect the way you feel retest using the fingertip If the fingertip result still does not reflect the way you feel please consult your healthcare professional e Do not rely on AST results for changing your treatment method e The amount of glucose in
34. w arkrayusa com Welcome to the GLUCOCARD Shine Blood Glucose Monitoring System Thank you for choosing the GLUCOCARD Shine Blood Glucose Monitoring System The system provides you with safe fast and convenient blood glucose in vitro i e outside the body diagnostic monitoring You can obtain accurate results in just 5 seconds with a small 0 5 uL blood sample Manufactured for SfXrfos USA INCG Minneapolis MN 55439 USA www arkrayusa com a E Contact Customer Service 800 566 8558 24 hours a day 7 days a week USA and Canada At all other times or in case of emergency please contact your healthcare professional or emergency medical response 2014 ARKRAY USA Inc Z P N 5146099 PGK7E0150 Rev010 2014
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