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Important Information: Read This First

To receive safe and optimum system benefits, please read the

entire contents of this manual before using the system. Please

note the following instructions:

•

Do not

use the system for diagnosis or screening of diabetes

• Use only fresh capillary whole blood samples for testing

• Alternate site and fingertip test results may differ

significantly due to rapid changes in the blood glucose level

after eating, insulin injection or exercise.

Intended Use

• The GLUCOCARD® Shine XL Blood Glucose Monitoring System

is intended for the quantitative measurement of glucose in

fresh capillary whole blood samples drawn from the fingertips

and alternate sites such as the forearm, palm, thigh and calf.

• Alternate site testing (AST) should be used only during steady-

state blood glucose conditions.

• The GLUCOCARD® Shine XL Blood Glucose Monitoring System

is intended for self-testing outside the body (

vitro

) by people

with diabetes as an aid to monitor the effectiveness of diabetes

control. It is not intended for use on neonates, and is not for

the diagnosis or screening of diabetes.

• GLUCOCARD® Shine Blood Glucose Test Strips are for use with

the GLUCOCARD® Shine family of blood glucose meters to

quantitatively measure glucose in fresh capillary whole blood

samples drawn from the fingertips and alternate sites.

• GLUCOCARD® Shine Control Solutions are for use with the

GLUCOCARD® Shine family of meters and GLUCOCARD® Shine

Test Strips to check that meter and test strips are working

together properly, and the test is performing correctly.

Содержание Glucocard SHINE XL

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

Страница 2: ...onitoring 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 five seconds with a small 0 5 µL blood sample AllRightsReserved P N5399 03Rev 01 21 PGK7E0172Rev301 2021 Customer Service 800 566 8558 24 hours a day 7 days a week In case of emergency please contact your healthcare profess...

Страница 3: ...___ 24 Preparing the Lancing Device_______________________________________ 25 Preparing the Meter and Test Strip___________________________________ 26 Flagging Post meal Test Results_____________________________________ 27 Applying the Blood Sample_________________________________________ 28 Discarding Used Lancets___________________________________________ 30 Alternate Site Testing_______________...

Страница 4: ...lternate sites such as the forearm palm thigh and calf Alternate site testing AST should be used only during steady state blood glucose conditions The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for self testing outside the body in vitro by people with diabetes as an aid to monitor the effectiveness of diabetes control It is not intended for use on neonates and is not for the di...

Страница 5: ...ly be used with GLUCOCARD Shine Test Strips 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 hyperosmolar state with or without ketosis Critical...

Страница 6: ...fices or long term care facilities because it has not been cleared by the FDA for use in these settings including for routine assisted testing or as part of glycemic control procedures Use of this device on multiple patients may lead to the transmission of Human Immunodeficiency Virus HIV Hepatitis C Virus HCV Hepatitis B Virus HBV or other bloodborne pathogens ...

Страница 7: ... capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 5 000 tests Power Two 3 0 V lithium batteries disposable type CR2032 Memory 250 test results Size 3 66 x 1 85 x 0 59 inch 93 x 47 x 15 mm Weight 1 82 oz 51 5 g with batteries Operating Ranges Temperature 50 104 ºF 10 40 ºC Relative humidity 10 90 Hematocrit 20 60 ...

Страница 8: ...rayusa com Specifications Storage Transport Conditions Temperature Glucose Meter with batteries 32 122 ºF 0 50 ºC Test strip 34 86 ºF 1 30 ºC Control solution 46 86 ºF 8 30 ºC Relative humidity Test strip 20 80 ...

Страница 9: ...tteries 2 Lancing Device Lancets 10 Logbook Carrying Case Check all the components after opening the GLUCOCARD Shine XL Blood Glucose Monitoring System package GLUCOCARD Shine Test Strips and Control Solutions are necessary but not included GLUCOCARD Shine Control Solutions and the data cable for the diabetes management system can be ordered separately Please contact Customer Service 800 566 8558 ...

Страница 10: ...e batteries run out completely Inserting or Replacing the Batteries Step 1 Make sure the meter is turned off Push the cover in the direction of the arrow to open the battery compartment Step 2 Remove the used batteries Insert two new batteries with the side facing up and make sure the batteries are inserted firmly Step 3 Place the cover on the battery compartment Push down firmly to close the cove...

Страница 11: ...ccurately It automatically absorbs the small blood sample applied to the narrow edge of the test strip Contact bars Gently push the test strip with its contact bars facing up into the test strip port of the 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 ...

Страница 12: ...est strips in a cool and dry place at a temperature between 34 86 ºF 1 30 ºC Keep test strips away from direct sunlight or heat and do not freeze Store test strips only in their original vial Close the vial tightly after taking out a test strip for testing and use the test strip immediately Avoid getting any liquid or moisture in the test strip vial This can affect the test strips and cause inaccu...

Страница 13: ...nces or liquid substances such as dirt blood or water enter into the meter The meter may be damaged or may malfunction Follow the warning information provided below to prevent possible damage to the meter Do not apply the blood or control solution samples directly to the test strip port Do not apply the blood or control solution samples to the test strip while holding the meter in a way that the t...

Страница 14: ...ay 7 days a week GLUCOCARD Shine XL Blood Glucose Meter Data Port Used to transfer data from the meter to a computer with a cable Button Turns the meter on and selects or changes information Display Shows results and messages Test Strip Port Insert test strip here Button Selects or changes information Button Turns the meter on off and confirms menu selections ...

Страница 15: ...est mark appears during post meal testing and when post meal test results are displayed Alarm symbol appears when the post meal alarm has been set Mute symbol appears only when the sound is set to OFF check appears when the control solution test results are saved or displayed Test results test results display panel mg dL unit for measuring blood glucose Blood insertion symbol indicates meter is re...

Страница 16: ...to scroll faster To complete the settings and exit from the SET mode press and hold the button for three seconds again Adjusting the Date and Time Step 1 Entering the SET Mode Press and hold the button for three seconds After all the segments flash across the screen SET is displayed on the screen Press the button again to progress to the next step Step 2 Setting the Year Press the or button until ...

Страница 17: ...to the next step Step 4 Setting the Date Press the or button until blinking number shows the correct date Press the button to confirm the date and progress to the next step Step 5 Setting the Time Format The meter can be set in the 12 hour AM PM or the 24 hour clock format Press the or button to select a format AM and PM are not displayed in the 24 hour format After selecting the format press the ...

Страница 18: ...or button until the correct hour appears Press the button to confirm the hour and progress to the next step Step 7 Setting the Minute Press the or button until the correct minute appears After setting the minute press the button to progress to the next step ...

Страница 19: ... test result is displayed When the button is pushed to set the post meal PP2 alarm When it is time for a preset blood glucose test Setting the Sound On OFF NOTE symbol is displayed only when the sound is set to OFF At any stage if the button is pressed for three seconds time and date will be saved and the meter will be turned off Press and hold the button to scroll through numbers quickly If the s...

Страница 20: ...r or new vial of test strips you should conduct a control solution test using GLUCOCARD Shine Control Solutions Follow the procedure that begins on page 21 NOTE Use GLUCOCARD Shine Control Solutions only Check the expiration date printed on the bottle When the control solution bottle is first opened record the discard date date opened plus three months in the space provided on the label Make sure ...

Страница 21: ...with a clean tissue or cloth Dispense a drop of control solution onto a clean non absorbent surface While the symbol blinks apply the control solution to the narrow edge of the test strip until the meter beeps Make sure the confirmation window of test strip fills completely Use GLUCOCARD Shine Control Solution when You want to practice the test procedure instead of using blood You use the meter fo...

Страница 22: ...er will switch off if the control solution sample is not applied within two minutes of the symbol appearing on the screen If the meter turns off press the or button and start from step two 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 test strips should be discarded safely in disposable containers Caution ...

Страница 23: ...sional or emergency medical response NOTE GLUCOCARD Shine Control Solutions can be obtained by contacting Customer Service 800 566 8558 Situations Actions 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 one or two drops of control solution were not discarded or the tip of the bottle was n...

Страница 24: ...es thick hard skin Choose a different site each time you test Using the Lancing Device A lancing device is needed in order to collect a blood sample You may use the lancing device contained in the GLUCOCARD Shine XL Blood Glucose Monitoring System or any other medically approved lancing device Adjustable Cap Lancet Holder Charger Release Button Ejection System Lancet The lancing device is for use ...

Страница 25: ...e lancet and set it aside then replace the adjustable cap Keep the protective cover to put on top of the used lancet after testing Preparing the Lancing Device Step 4 The lancing device has five puncture depth settings numbered 1 through 5 The smaller numbers are for a shallower puncture and the larger numbers are for a deeper puncture Choose a depth of penetration by rotating the top portion of t...

Страница 26: ...fferent sample sites The lancing device s adjustable cap allows the best depth of skin penetration for an adequate sample size A beginning setting of 3 is recommended Step 6 Insert a test strip with the contact bars facing up into the meter s test strip port Push the test strip gently into the test strip port until the meter automatically turns on and the symbol appears Preparing the Meter and Tes...

Страница 27: ...nt to save the result as a post meal test move on to step 8 after step 6 If you want to delete the post meal flag that has been attached press and hold the button for three seconds again before applying the blood sample Flagging Post meal Test Results GLUCOCARD Shine XL Meter allows post meal test to be flagged with the symbol The post meal flag can be attached and deleted just before applying the...

Страница 28: ... test strip insert a new one and apply the blood sample again after the symbol appears on the screen 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 lancing device from the finger Wait a few seconds for a blood drop to form A minimum volume of 0 5 μL is...

Страница 29: ...fter the test result has been displayed the meter will automatically switch off after three seconds Discard used test strip safely in a disposable container NOTE The meter will switch off if the blood sample is not applied within two minutes of the symbol appearing on the screen If the meter turns off press the or button and apply the blood sample after the symbol appears on the screen ...

Страница 30: ... in a proper biohazard container Discarding Used Lancets CAUTION Check for damage before using the lancet If it has been damaged please discard it and use another lancet The lancet is very sharp Please keep away from children Keep the lancets in a cool and dry place The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly ...

Страница 31: ... it may not be simple for everyone and the following precautions should be observed during testing Alternate 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 alternate site sampling Firmly press a...

Страница 32: ...s Acceptable Situations for AST When your blood glucose levels are stable Fasting period Before a meal Before going to bed Situations Requiring Fingertip Test When your blood glucose levels are NOT stable Two hours after a meal or exercise When sick or when glucose levels seem quite lower than test value When hypoglycemia is not well recognised When insulin has the biggest effect Two hours after a...

Страница 33: ...tment method The amount of glucose in alternate sites differs from person to person Before using AST please consult your healthcare professional NOTE Results from alternate 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 sympto...

Страница 34: ...es 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 upon retesting please contact your healthcare professional immediately Lo Message Lo appears when a test result is less than 20 mg dL and indicates severe hypoglycemia very ...

Страница 35: ...dical Care in Diabetes 2018 Diabetes Care January 2018 vol 41 Supplement 1 S13 S27 Before breakfast Before lunch or dinner One hour after meals Two hours after meals Between 2 a m and 4 a m Reminders Time of day Your target ranges from your healthcare professional Test results stored in GLUCOCARD Shine XL Meter can be transferred from the meter to the ARK Care Advance Real Time Diabetes Management...

Страница 36: ...ton again the average values and the number of tests performed post meals for the same period will appear on the screen The GLUCOCARD Shine XL Meter can save up to 250 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 XL Meter calculates and displays the averages of total test results p...

Страница 37: ...e test results starting from the most recent and ending with the oldest Press the button to return to the previous result After checking the stored test result press the button to turn off the meter NOTE Press and hold the button to scroll through the test results ...

Страница 38: ... OFF To turn off the PP2 alarm press and hold the button for three seconds PP2 the symbol and OFF will appear on the screen Then the screen will change automatically to the memory check mode without symbol displayed Setting the Alarm Function Setting the Post meal Alarm PP2 Alarm Four types of alarms can be set in the GLUCOCARD Shine XL Meter One post meal alarm PP2 alarm and three time set alarms...

Страница 39: ...the screen alarm 1 will be displayed Step 2 On pressing the button alarm 1 is set and On is displayed on the screen Press the button again to cancel alarm 1 and OFF will blink on the screen Step 3 Press the button to adjust the hour of alarm 1 A number indicating the hour will blink on the screen Press the button to set the hour Setting the Time Alarms Alarm 1 3 ...

Страница 40: ...ndicating the minute will blink on the screen Press the button to set the minute Step 5 Press the button to finish and enter alarm 2 mode Repeat steps 2 to 4 to set the remaining time alarms alarm 2 and 3 Step 6 Press and hold the button for three seconds to finish and turn the meter off ...

Страница 41: ...ose 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 Store all meter components in the carrying case to prevent loss Avoid getting any liquid or moisture in the test s...

Страница 42: ...o do Remove the test strip and insert a new test strip Repeat the test with a new test strip and wait until the symbol appears before applying the blood or control solution sample Move to an area where the temperature is within the operating range 50 104 ºF and repeat the test after the meter and test strips have reached a temperature within the operating range The blood sample is of insufficient ...

Страница 43: ...at the test with a GLUCOCARD Shine Test Strip Insert the test strip with the contact bars facing up and push in gently until the meter turns on Do NOT use the meter Contact Customer Service 800 566 8558 24 hours a day 7 days a week Repeat the test with a new test strip If the error message persists contact Customer Service 800 566 8558 24 hours a day 7 days a week What it means What to do This err...

Страница 44: ...the contact bars facing up Check if the test strip has been inserted completely into the test strip port Check if the appropriate test strip was used Check if the batteries are inserted correctly Replace the batteries The test does not start even after applying the blood sample on the test strip Check if the confirmation window is filled adequately Repeat the test after inserting a new test strip ...

Страница 45: ...ained 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 Obtained by healthcare professionals Obtained by lay users Slope 1 023 1 032 Y intercept 1 86 mg dL 3 63 mg dL Correlation coefficient r 0 995 0 985 Number of samples 110 105 Range tested 30 485 mg dL 67 413 mg dL Accuracy results for...

Страница 46: ... 324 mg dL 38 mg dL 86 mg dL 125 mg dL 189 mg dL 334 mg dL Blood avg Blood avg Blood avg Blood avg Blood avg Control avg Control avg Control avg Alternate Sites Testing Evaluation Comparison of results using various AST sites with the results of YSI measurements Alternate site test results for glucose concentration 75 mg dL Within 5mg dL Within 10 mg dL Within 15 mg dL Fingertip Forearm Palm Thigh...

Страница 47: ... 56 3 19 48 39 6 28 48 58 3 17 48 35 4 27 48 56 3 48 48 100 48 48 100 48 48 100 48 48 100 48 48 100 46 48 95 8 42 48 87 5 38 48 79 2 36 48 75 0 46 48 95 8 48 48 100 47 48 97 9 46 48 95 8 46 48 95 8 48 48 100 Fingertip Forearm Palm Thigh Calf Within 5 Within 10 Within 15 Within 20 Test site ...

Страница 48: ... at its discretion repair or replace a defective meter or meter part that is covered by this warranty As a matter of warranty policy the manufacturer 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 Returns For instructions on how to return your meter contact Custome...

Страница 49: ...www arkrayusa com 49 MEMO ...

Страница 50: ...50 www arkrayusa com MEMO ...

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