Arkray Glucocard Shine Page 46 User Manual Download

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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 Model 2300 Glucose Analyzer, a lab

instrument. The results below were obtained by diabetic patients

at clinic centers.

Within ± 5%

Within ± 10%

Within ± 15%

Within ± 20%

79/95 (83.2%) 94/95 (98.9%)

95/95 (100%)

5/5 (100%)

Accuracy results for glucose concentration < 75 mg/dL

Accuracy results for glucose concentration ≥ 75 mg/dL

5/5 (100%)

Within ± 10 mg/dL

Within ± 5 mg/dL

Within ± 15 mg/dL

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

Range tested

66-321 mg/dL

Obtained by healthcare

professionals

Obtained by

lay users

Summary of Contents for Glucocard Shine

Page 1: ...For single user home use only User Manual ...

Page 2: ... Checking the System 18 Control Solution Testing 19 Comparing the Control Solution Test Results 21 Testing Using the Lancing Device 22 Preparing the Lancing Device 23 Preparing the Meter and Test Strip 25 Flagging Post meal Test Results 25 Applying Blood Sample 26 Discarding Used Lancets 28 Alternative Site Testing 29 HI and Lo Messages 32 Target Blood Glucose Ranges 33 Transferring Test Results 3...

Page 3: ...ot 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 GLUCOCARD Shine Test Strips to check that the...

Page 4: ...e Meter should be used only with the GLUCOCARD Shine Test Strip An abnormally high or low red blood cell count hematocrit level over 60 or below 20 may produce inaccurate results 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 hyperosmola...

Page 5: ...attery 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 Temperature 50 104 F 10 40 C Relative humidity 10 90 Hematocrit 20 60 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 you...

Page 6: ...rying Case Check all the components after opening the GLUCOCARD Shine Blood Glucose Monitoring System package 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 7 days a week US and Canada Caution...

Page 7: ...atteries Note Removing the meter batteries will not affect your stored result However you may need to reset your meter settings See pages 13 17 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 fac...

Page 8: ... the test strip with its contact bars facing up into the test strip port of meter Confirmation window Check here to see whether sufficient blood sample has been applied Edge to apply blood sample Apply blood sample here for testing Important Safety Instruction All components that come into contact with blood samples should be considered to be biohazards capable of transmitting viral diseases even ...

Page 9: ...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 methods Store test strips in a cool and dry place at a temperature of 34 86 F 1 30 C Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original vial Close the vi...

Page 10: ...00 566 8558 GLUCOCARD Shine Blood Glucose Meter Data Port Used to transfer data from the meter to a computer with a cable Button Turns the meter on off confirms menu selections and changes information Display Shows results messages Test Strip Port Insert test strip here Button Turns the meter on selects or changes information ...

Page 11: ...e 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 Temperature symbol displays recorded temperature when blood glucose levels are tested Blood insertion symbol indicates meter is ready for the application of a drop of blood or control solution Decimal point appears when the bloo...

Page 12: ...d hold the 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 button again to set the year Step 2 Setting the Year Press and release to adjust until the correct year appears After setting the year press the button to confirm your selection and set the month Step 3 Setting the Month A number indicating the month will bl...

Page 13: ...ect day Press the 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 to select a format AM PM is not displayed in the 24 hour format After selecting the format press the button to set the hour Step 6 Setting the Hour Press until the correct hour appears After the hour is set press the button to set ...

Page 14: ...ton 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 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 Setting the Sound On OFF Note When the sound is set t...

Page 15: ...o 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 Turn on the Strip Expiration Date Indicator 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 ...

Page 16: ...ired hypoglycemic level between 20 and 60 mg dL is being displayed Then press the button to confirm the level Turn on the Hypoglycemia HYPo Indicator Caution Before the HYPo indicator is set ask your doctor or diabetes nurse to help you decide what your hypoglycemia level will be Note If the test result is lower than the pre set hypoglycemia level the meter will display the following If you do not...

Page 17: ...evels of solutions Control Level 1 and 2 Notes GLUCOCARD Shine Meter and GLUCOCARD Shine Test Strips only can be used with GLUCOCARD Shine Control Solutions 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 Make sure your meter test strips and control solutions ar...

Page 18: ...y If your symptoms are inconsistent with the blood glucose test results and you feel that the meter or test strips are not working properly If you drop or damage the meter When using the meter for blood glucose test after any disinfection procedure Step 2 Shake the GLUCOCARD Shine Control Solution bottle before each test Remove the cap and squeeze the bottle to discard the first 1 or 2 drops Then ...

Page 19: ... appears on the display When the check symbol is displayed 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 meter to the range printed on the test strip vial The result should fall within that range Used strips should be discarded safely in disposable containers Caution The ranges printed on the test strip vial are for th...

Page 20: ...ately Contact Customer Service 800 566 8558 24 hours a day 7 days a week US and Canada Situations When the control solution bottle was not shaken well When the meter test strip or the control solution were exposed to high or low temperatures When the first drop of the control solution was not discarded or the tip of the bottle was not wiped clean When the meter is not functioning properly When the...

Page 21: ...and lancing device clean 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 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 Monitorin...

Page 22: ... 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 Preparing the Lancing Device ...

Page 23: ...ortion 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 sleeve with the other hand until the device clicks 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...

Page 24: ...esult of a post meal test with symbol The post meal test flag can be attached just before applying the blood sample Once you attach the post meal flag to the test results it cannot be deleted Step 7 If you want to attach a post meal flag to a test result press and hold for 3 seconds after inserting the test strip The post meal flag and the symbol will appear on the screen The test result will also...

Page 25: ...m 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 test 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 te...

Page 26: ...ved after the test result is displayed the meter will automatically switch off after 3 seconds Discard used test strip safely in a disposable container Note The meter will switch off if the blood sample is not applied within 2 minutes of the symbol appearing on the screen If the meter turns off remove the strip reinsert it and apply the blood sample after symbol appears on the screen ...

Page 27: ...o dispose of the used lancet in a proper biohazard container Discarding Used Lancets Caution Check for damages before using the lancet If they have been damaged please discard it and use other lancet The lancet is very sharp Please keep away from children Keep the lancets in a cool and dry place Caution The lancet is for single use only Never share or reuse a lancet Always dispose of lancets prope...

Page 28: ...ot be simple for everyone and the following precautions should be observed during testing Alternative Sites for Testing 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 sit...

Page 29: ...ingested food having an effect on glucose levels Acceptable situations for AST Fasting period Before a meal Situations requiring fingertip test When the glucose levels are rapidly increasing such as during the two 2 hours after a meal or exercise When sick or when glucose levels seem quite lower than test value When hypoglycemia is not well recognized When insulin has the biggest effect Two 2 hour...

Page 30: ...he amount of glucose in alternative sites differs from person to person 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...

Page 31: ...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 symbol also appears Note If messages for hyperglycemia or hypoglycemia are displayed even if you do not have those...

Page 32: ...l 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 softwa...

Page 33: ...to view 7 14 30 and 90 day average values and the number of tests performed for the last test period 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 a...

Page 34: ...t period Step 4 Viewing Post meal Averages On pressing the 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 button to turn off the meter Use the button to scroll back through the averages seen previously button button Pre meal average 1 7 14 30 90 days button button Post meal average 1 7 14 30 90 days ...

Page 35: ... the test results saved within the current day Viewing Test Results Step 2 Use the button to scroll through the test results starting from the most recent and ending with the oldest Press the 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 button to turn off the meter button The number of tes...

Page 36: ...is time the alarm indicating that the PP2 alarm has been set will be displayed on the screen Step 2 Setting the PP2 alarm OFF To turn off the PP2 alarm press and hold for 3 seconds The PP2 and the OFF will appear on the screen Then the screen will change automatically to the memory check mode without the alarm being displayed The PP2 alarm goes off 2 hours after setting the alarm The alarms ring f...

Page 37: ...s Press the button to confirm the year and set the month 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 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 Note The strip expiration date is prin...

Page 38: ... 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 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 disinfecti...

Page 39: ...rox Germicidal Wipes before using it 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 Name Manufacturer EPA registration number Active ingredients Clorox Germicidal Wipes Clorox Professional Products Company Pho...

Page 40: ...ly using a new towelette to remove blood borne pathogens Dispose of the used towelette in a trash bin Allow exteriors to remain wet for 1 minute then wipe the meter using a dry cloth 1minute dry cloth 5 6 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 Front Back Both sides 2 3 4 ...

Page 41: ...ages 19 20 for how to do a control solution test 7 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 7 days a week US and Canada When the inscriptions on the exterior of the meter or lancing device have been removed When the color of the meter or lancing device has changed...

Page 42: ...er or hold it under running water because this will damage the meter Caution Storage and Handling Do not expose the meter to direct sunlight or heat for extended periods of time Do not let dirt dust blood or water enter into the meter s test strip port Do not drop the meter or subject it to strong shocks Do not try to fix or alter the meter in any way Keep the meter in a cool and airy place Keep t...

Page 43: ...ars before applying the blood or control solution sample The blood sample has abnormally high viscosity or insufficient volume Repeat the test using a new test strip There is a problem with the meter Do not use the meter Contact Customer Service at 800 566 8559 24 hours a day 7 days a week US and Canada This error message may appear when the wrong blood glucose test strip is used instead of GLUCOC...

Page 44: ...ere 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 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 w...

Page 45: ... if the confirmation window is filled completely Repeat the test after inserting a new test strip Repeat the test after inserting a new test strip Check the expiration date of the test strip Check the meter The display is blank even after inserting a test strip The test does not start even after applying the blood sample on the strip The test result doesn t match the way you feel General Troublesh...

Page 46: ...obtained using a YSI Model 2300 Glucose Analyzer a lab instrument The results below were obtained by diabetic patients at clinic centers Within 5 Within 10 Within 15 Within 20 79 95 83 2 94 95 98 9 95 95 100 95 95 100 5 5 100 Accuracy results for glucose concentration 75 mg dL Accuracy results for glucose concentration 75 mg dL 5 5 100 5 5 100 Within 10 mg dL Within 5 mg dL Within 15 mg dL Slope 1...

Page 47: ...dies were performed in a laboratory using the GLUCOCARD Shine System Alternative Sites Testing Evaluation Comparison of results using various AST sites with the results of YSI measurements Alternative site test results for glucose concentration 75 mg dL This study shows that there could be variation of up to 4 3 Fingertip Forearm Palm Thigh Calf Within 5 mg dL 5 5 100 5 5 100 5 5 100 4 5 80 3 5 60...

Page 48: ...dL Fingertip Forearm Palm Thigh Calf Within 5 95 95 100 69 95 72 6 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 Within 20 95 95 100 95 95 100 95 95 100 95 95 100 95 95 100 ...

Page 49: ...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 mu...

Page 50: ...e the body diagnostic monitoring You can obtain accurate results in just 5 seconds with a small 0 5 µL blood sample 2014ARKRAYUSA Inc Manufactured for Minneapolis MN 55439 USA www arkrayusa com 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 P N 514...

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