Arkray Gluocard Shine Express, User Manual

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

Page 2: ... Street Minneapolis MN 55439 U S A 800 566 8558 www arkrayusa com Technical Customer Service 800 566 8558 24 hours a day 7 days a week In case of emergency please contact your healthcare professional or emergency medical response P N 5531 00 PGUAA 0000034 REV0 11 2018 ...

Page 3: ...lood Glucose Monitoring System Offers users a bilingual English and Spanish speaking meter The speaking function which is an acoustic aid for users provides voice prompts for set up instructions test results results averaging and error messages No part of this document may be reproduced in any form or by any means without the prior written consent of the manufacturer The information in this manual...

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Page 5: ..._ _ _ _ _ _ _ _ _ 31 Preparing the Meter and Test Strip _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 33 Applying Blood Sample _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _...

Page 6: ...iabetes control The system is intended to be used by a single person and should not be shared The system 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 Express Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip ...

Page 7: ...ntended use described in this user manual Please follow the suggested cleaning and disinfection procedures described in this user manual GLUCOCARD Shine Blood Glucose Test Strips are intended for single use only They should be disposed of in an appropriate container immediately after use ...

Page 8: ...n 10 000 ft 3 048 m above sea level may have an effect on the performance of the test strip This single patient use system is for single patient use only and should not be shared Not for neonatal use Do not use for diagnosis of or screening for diabetes mellitus Not for use on critically ill patients Not for use on anyone undergoing oxygen therapy This device is not intended for use in healthcare ...

Page 9: ...imize code related errors in monitoring by using the no coding function The GLUCOCARD Shine Express Blood Glucose Meter should be used only with GLUCOCARD Shine Blood Glucose Test Strips If your test result is below 60 mg dL or above 240 mg dL consult a healthcare professional immediately Not for use in anyone undergoing oxygen therapy For questions or concerns contact Technical Customer Service 8...

Page 10: ...onds Sample type Fresh capillary whole blood Calibration Plasma equivalent Assay method Electrochemical Battery life 3 000 tests Power Two 1 5 V AAA alkaline batteries Memory 1 000 test results Size 4 06 x 2 23 x 0 67 inches 103 x 54 x 17 mm Weight 2 53 oz 70 9 g with batteries Temperature 42 8 111 2 F 6 44 C Relative humidity 10 90 Hematocrit 15 65 ...

Page 11: ... Shine Control Solution Level 1 and Level 2 are necessary but not included Control solutions can be purchased separately by contacting Technical Customer Service at 800 566 8558 24 hours a day 7 days a week Check all components after opening the GLUCOCARD Shine Express Blood Glucose Monitoring System package The exact contents are listed on the main box The cable for the data management system can...

Page 12: ...e the batteries should be replaced as soon as possible 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 and insert two new batteries Close the battery cover firmly NOTE Removing the meter batteries will not affect your stored results However you may need to res...

Page 13: ...urately It automatically absorbs the small blood sample applied to the narrow edge of the test strip Insert Contact bars Gently push 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 ...

Page 14: ...l and dry place at a temperature between 34 86 F 1 30ºC and 20 80 relative humidity 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 Handle test strips only with clean and dry hands Do not bend cut or alter test strips in any way For ...

Page 15: ...the used test strips Data Port Used to transfer data from the meter to a computer with a cable Button Turns the meter on selects or changes information Test Strip Port Insert test strip here NOTE The cable for the data management system can be ordered separately Please contact Technical Customer Service 800 566 8558 24 hours a day 7 days a week The unit of measurement is fixed in mg dL and cannot ...

Page 16: ...needs to be replaced Blood insertion symbol indicates meter is ready for the application of a drop of blood or control solution Pre meal test flag used for tests done before eating Post meal test flag used for tests done after eating Fasting test flag used for tests done after fasting for at least 8 hours Month Day Hour Minute GLUCOCARD Shine Express Blood Glucose Meter Display 10 12 7 8 9 11 13 4...

Page 17: ...urn off the meter You will hear a voice prompt say The set date and time is September twenty fourth two thousand eighteen twelve thirty seven PM Press the or button to change values Press and hold the or button to scroll faster Step 1 Entering the SET Mode Press and hold the button for three 3 seconds to enter SET mode After all the segments flash across the screen SET will show up and you will he...

Page 18: ...g a Language The meter has a bilingual talking function that can be used as a verbal aid for using the meter and hearing test results When entering the language selection mode for the first time L1 will be blinking and you will hear a voice prompt say Set language in the default language English To select another language L2 Spanish press the or button then press the button to confirm your selecti...

Page 19: ...ber indicating the month will blink on the screen Press the or button until the correct month appears Press the button to confirm your selection and go to the next step You will hear a voice prompt say Set date Voice prompt September Step 5 Setting the Date A number indicating the date will blink on the screen Press the or button until the correct date appears Press the button to confirm the date ...

Page 20: ... the hour and go to the next step You will hear a voice prompt say Set minute Voice prompt Twelve PM Step 8 Setting the Minute A number indicating the minute will blink on the screen Press the or button until the correct minute appears Press the button to confirm the minute and go to the next step You will hear a voice prompt say Set volume Voice prompt Twelve thirty seven PM ...

Page 21: ...bol will appear on the display and the meter will be muted Press the button to save the setting and go to the next step You will hear a voice prompt say Set expiration date of the test strip Step 9 Setting the Sound On OFF A number showing the sound volume will blink on the screen Press the or button to adjust the volume from 1 lowest to 5 highest or to turn the beep sound OFF or On Voice prompt V...

Page 22: ...F only See page 24 to set the test strip expiration date NOTE If the preset expiration date expires the meter will display EP when the test strip is inserted The display will alternate between EP and the date and time when the test result is displayed right after the test If the expiration date is set to October of 2019 the meter will display EP at the start of November 2019 Voice prompt Off Voice...

Page 23: ...tor 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 CAUTION Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your hypoglycemia level Voice prompt Eighty five milligrams per deciliter NOTE If the test result is lower than the pre set h...

Page 24: ...mpt say Set years Press the or button until the correct year appears Press the button to confirm the year and go to the next step You will hear a voice prompt say Set month NOTE The test strip expiration date is printed on the test strip vial Step 3 Setting the Expiration Month A number indicating the month will blink at the bottom of the screen Press the or button until the correct month appears ...

Page 25: ... drops and wipe the tip clean Close the control solution bottle tightly and store at a temperature between 46 86ºF 8 30ºC Checking the System You may check your meter and test strips using the GLUCOCARD Shine Control Solution Level 1 and or 2 GLUCOCARD Shine Control Solutions contain known amounts of glucose and is used to check that the meter and test strips are working properly The test strip vi...

Page 26: ...nds To undo the control solution flag press the button for three 3 seconds again You may do a control solution test When you want to practice the test procedure using the control solution instead of blood When using the meter for the first time Whenever you open a new vial of test strips If the meter or test strips do not function properly If your symptoms are inconsistent with the blood glucose t...

Page 27: ...bsorbent surface It helps to squeeze a drop onto the top of the cap as shown After the 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 NOTE The meter may switch off if the control solution sample is not applied within two 2 minutes of the symbol appearing on the screen If the meter turns ...

Page 28: ...d fall within the range Example range shown Please see your current vial of test strips for the actual range Control Solution Range Level 1 101 151 mg dL Level 2 184 276 mg dL NOTE GLUCOCARD Shine Control Solutions can be ordered separately by contacting Technical Customer Service 800 566 8558 24 hours a day 7 days a week CAUTION The range printed on the test strip vial is for GLUCOCARD Shine Cont...

Page 29: ...l Customer Service 800 566 8558 24 hours a day 7 days a week Situations Do This When the control solution bottle was not shaken well When the meter test strip or control solution have been exposed to high or low temperatures When the first drop of control solution were not discarded or the tip of the bottle was not wiped clean When the meter is not functioning properly Repeat the control solution ...

Page 30: ...u test Using the Lancing Device Adjustable Tip Lancet Holder Charger Release Button Ejection System Lancet You will need a lancing device in order to collect a blood sample You may use the lancing device that is included in the GLUCOCARD Shine Express Blood Glucose Monitoring System or any other medically approved lancing device The lancing device is for use by a single user only and should not be...

Page 31: ...water Rinse and dry thoroughly Unscrew and remove the lancing device tip Firmly insert a new disposable lancet into the lancet holder Hold the lancet firmly Gently twist to pull off protective disk Save disk to recap lancet after use Replace lancing device tip Preparing the Lancing Device ...

Page 32: ... of penetration by rotating the top portion of the adjustable tip until the setting number matches the arrow Cock the lancing device by holding the body in one hand and pulling on the charger A click may be heard NOTE The skin depth to get blood samples will vary by person at different sample sites The lancing device s adjustable cap allows the best depth of skin penetration to get an adequate sam...

Page 33: ...drop to form A minimum volume of 0 5 microliter is needed to fill the confirmation window approximate size of 0 5 μL Applying Blood Sample Step 6 Insert a test strip with the contact bars facing up into the meter s test strip port Push the test strip in gently until the meter beeps Be careful not to bend the test strip The symbol will appear on the screen and you will hear a voice prompt say Blood...

Page 34: ... appearing on the screen If the meter turns off remove the test strip reinsert it and start from Step 2 Step 8 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 confirmation window is not filled in time because of abnormal viscosity thickness and stickiness or insufficient volume the Er4 message may appear Good Sample Ins...

Page 35: ...eter counts down from 5 to 1 The test 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 three 3 seconds Discard used test strips safely in a disposable container Test result Voice prompt Your blood glucose result is one hundred three milligrams per deciliter ...

Page 36: ...ting flag or a Control Solution flag When you remove the test strip while the desired flag is blinking the test result is stored with the flag If you do not want to add any flags on the test result remove the test strip after the test result is displayed No flag Pre meal flag Post meal flag Control solution flag Voice prompt No flag Voice prompt Pre meal test Voice prompt Post meal test Fasting fl...

Page 37: ... lancing device Stick the lancet into the saved protective disk Remove lancet and dispose of the used lancet in a proper biohazard container Discarding Used Lancets CAUTION The lancet is for single use only Never share or reuse a lancet Always dispose of lancets properly ...

Page 38: ...yperglycemia much higher than normal glucose levels If HI is displayed again upon retesting please contact your healthcare professional immediately Lo appears when a test result is less than 20 mg dL and indicates severe hypoglycemia very low glucose levels If Lo is displayed again upon retesting please contact your healthcare professional immediately Voice prompt Your blood glucose result is abov...

Page 39: ...od glucose levels for an adult without diabetes are below 100 mg dL before meals and fasting and are less than 140 mg dL two hours after meals 1 Fasting is defined as no caloric intake for at least eight hours Reference 1 American Diabetes Association Standards of Medical Care in Diabetes 2018 Diabetes Care January 2018 vol 41 Supplement 1 S13 S27 Your target ranges from your healthcare profession...

Page 40: ...ement System via a data cable The meter screen displays Pc and you will hear a voice prompt say Communication cable is connected when the data cable connects the meter with a computer If the data cable is disconnected from the computer you will hear a voice prompt say Communication cable is disconnected NOTE For more information contact Technical Customer Service 800 566 8558 24 hours a day 7 days...

Page 41: ...es The GLUCOCARD Shine Express Blood Glucose Meter can save up to 1 000 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 meter calculates and displays the averages of Total test results Pre meal test results Post meal test and Fasting test results from the last 1 7 14 30 and 90 days The number of test...

Page 42: ...e prompt The average for seven days of total measurements is one hundred eighteen milligrams per deciliter Step 3 Viewing Pre meal Averages Continue to press the button to view 1 7 14 30 and 90 day average values and the number of tests performed pre meals with the symbol for the last test period button button Pre meal Average 1 7 14 30 90days Voice prompt The average for ninety days of pre meal i...

Page 43: ...fasting with the symbol for the last test period button button Post meal Average 1 7 14 30 90days Voice prompt The average for ninety days of post meal is one hundred eighty nine milligrams per deciliter Voice prompt The average for one day of post meal is one hundred seventy three milligrams per deciliter button button Fasting Average 1 7 14 30 90days Voice prompt The average for ninety days of f...

Page 44: ...tion test results saved with symbol will be displayed with symbol when you review the stored test results button button Voice prompt November twenty second eight thirty AM pre meal blood glucose result is one hundred milligrams per deciliter Voice prompt August third twelve three PM fasting blood glucose result is one hundred forty milligrams per deciliter Step 6 Use the button to scroll back thro...

Page 45: ...st meal alarm PP2 Alarm and three 3 time set alarms alarm 1 3 The PP2 Alarm goes off 2 hours after setting the alarm The alarms ring for 15 seconds and can be silenced by pressing any button or by inserting a test strip Setting the Post meal Alarm PP2 Alarm NOTE The PP2 Alarm will automatically turn off if the meter s time setting is adjusted to more than two hours before or just past the currentl...

Page 46: ...e symbol displayed disappears Step 1 Without inserting a test strip press the and buttons at the same time for three 3 seconds to enter the time alarm setting alarm1 will be displayed while OFF blinks on the screen Setting the Time Alarms Alarm 1 3 To turn off the PP2 Alarm press and hold the button for three 3 seconds Voice prompt Post meal alarm is off Voice prompt Set alarm one ...

Page 47: ...2 On pressing the button alarm1 is set and On is displayed on the screen Press the button again to cancel alarm1 OFF will blink on the screen and you will hear a voice prompt say Off Voice prompt On Press the button to adjust the time of alarm1 A number representing the hour will blink on the screen and you will hear a voice prompt say Set hour Press the button to set the hour Voice prompt Four PM...

Page 48: ...to go to alarm2 setting and you will hear a voice prompt say Set alarm two Repeat steps 2 to 4 to set the remaining time alarms alarm 2 3 Press the button for three 3 seconds to finish and turn the meter off You will hear a voice prompt say Alarm setting is completed ...

Page 49: ...rt 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 bloodborne pathogens For the meter and lancing device this pre cleaning and disinfection procedure should be performed once a week NOTE The life span of a GLUCOCARD Shine Express meter is 5 years We re...

Page 50: ...ancing 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 Express Blood Glucose Monitoring System instruction please read the instructions provided by the manufacturer of Clorox Germicidal Wipes before using them NOTE The disinfectant product can be purchased through online retai...

Page 51: ...orizontally and three 3 times vertically using a new towelette to disinfect the meter 2 Wipe the entire surface of the meter three 3 times horizontally and three 3 times vertically using one towelette to pre clean blood and other body fluids 3 Dispose of the used towelette in a trash bin Front Back Both sides 6 Allow exteriors to remain wet for one 1 minute then wipe the meter using a dry cloth 5 ...

Page 52: ...trip vial See pages 26 28 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 Technical Customer Service 800 566 8558 24 hours a day 7 days a week When the inscriptions on the exterior of the meter or lancing device have been removed When the color of the meter or lancing device ha...

Page 53: ... Storage and Handling Store the meter in a cool and dry place between 32 122 F 0 50ºC and 20 80 relative humidity Do not expose the meter to direct sunlight heat or excessive humidity for an extended period 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 shock Do not try to fix or alter the meter in any way Strong ele...

Page 54: ...erature during the test was above or below the operating range Voice prompt Error 3 The temperature is out of the operating range Please move to an area where the temperature is within the operating range and repeat the test after the meter has reached a temperature within the operating range Move to an area where the temperature is within the operating range 42 8 111 2ºF 6 44ºC and repeat the tes...

Page 55: ...t Error 6 There is a problem with the meter Please contact customer service representative Do not use the meter Contact Technical Customer Service 800 566 8558 24 hours a day 7 days a week An electronic error occurred during the test Voice prompt Error 8 The test was not performed properly Please repeat the test with a new test strip Repeat the test with a new test strip If the error message persi...

Page 56: ...est strip has been inserted completely into the test strip port Check if the appropriate test strip was used Check whether the batteries are correctly inserted 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 completely Repeat the test after inserting a new test strip The test result doesn t match the wa...

Page 57: ...hose obtained using a YSI Model 2300 Glucose Analyzer a laboratory instrument The following results were obtained by diabetic patients at clinic centers Accuracy results for glucose concentration 75 mg dL Accuracy results for glucose concentration 75 mg dL Slope 1 0223 Y Intercept 1 3686 Elation coefficient r 0 9934 Number of subjects 371 Range tested 48 mg dL 553 mg dL Within 5 mg dL Within 10 mg...

Page 58: ...d 553 mg dL Within 15 mg dL and Within 20 371 371 100 Within Run Precision Blood avg 43 mg dL SD 1 9 mg dL CV 4 3 Blood avg 71 mg dL SD 2 1 mg dL CV 2 9 Blood avg 135 mg dL SD 3 8 mg dL CV 2 8 Blood avg 203 mg dL SD 5 2 mg dL CV 2 6 Blood avg 343 mg dL SD 11 mg dL CV 3 2 Between Run Precision Control avg 36 mg dL SD 1 4 mg dL CV 3 8 Control avg 114 mg dL SD 3 4 mg dL CV 3 0 Control avg 341 mg dL S...

Page 59: ... made within the warranty period The manufacturer 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 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 in...