Arkray GLUCOCARD Shine Connex, 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 5524 01 Rev 04 19 PGUAA 0000033 REV1 04 2019 ...

Page 3: ...rtphone The GLUCOCARD Shine Connex Meter is designed to work with the ARK Care VITA mobile app When using the GLUCOCARD Shine Connex Blood Glucose System we suggest you pair your GLUCOCARD Shine Connex Meter with your smartphone and track your test results 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...

Page 4: ... other trademarks and trade names are those of their respective owners FCC Radiation Exposure Statement This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment This equipment should be installed and operated with minimum distance 8 inches 20 cm between the radiator and your body Any changes or modifications not expressly approved by the manufacturer cou...

Page 5: ...ndicator 25 Turning on the Hypoglycemia HYPo Indicator 26 Setting the Test Strip Expiration Date Indicator 27 Checking the System 28 Control Solution Testing 29 Comparing the Control Solution Test Results 32 Testing Using the Lancing Device 33 Preparing the Lancing Device 34 Preparing the Meter and Test Strip 36 Applying Blood Sample 36 Discarding Used Lancets 40 HI and Lo Messages 41 Target Blood...

Page 6: ...e 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 The GLUCOCARD Shine Blood Glucose Test Strips are for use with the the GLUCOCARD Shine family of blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip The GLU...

Page 7: ...ed of in an appropriate container immediately after use The GLUCOCARD Shine Connex Blood Glucose Meter is designed to minimize code related errors in monitoring by using the no coding function Glucose in blood samples reacts with the chemical in the test strip to produce a small electrical current The GLUCOCARD Shine Connex Meter detects this electrical current and measures the amount of glucose i...

Page 8: ...your healthcare professional immediately Altitudes of higher than 10 000 ft 3 048 m above sea level may have an effect on the performance of the test strip This 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 For i...

Page 9: ...term care facilities because it has not been cleared by 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 transmission of Human Immunodeficiency Virus HIV Hepatitis C Virus HCV Hepatitis B Virus HBV or other bloodborne pathogens ...

Page 10: ...ife 1 000 tests Power Two 3 0 V lithium batteries disposable type CR2032 Memory 1 000 test results Size 4 06 x 2 23 x 0 63 inches 103 x 54 x 16 mm Weight 2 54 oz 72 1 g with batteries Bluetooth Frequency range 2 4 2 4835 GHz technology Operating range distance maximum 32 feet 10 meters unobstructed Operating channels 40 channels Security encryption 128 bit AES Advanced encryption standard Temperat...

Page 11: ...iring Quick Guide Batteries 2 Lancing Device Lancets 10 Logbook Carry Case Check all the components after opening the GLUCOCARD Shine Connex Blood Glucose Monitoring System package GLUCOCARD Shine 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 ARKRAY Technical Customer...

Page 12: ...s 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 and insert two new batteries with the side facing up Make sure the batteries are inserted firmly Step 3 Place the cover on the battery compartment Push down firmly to close the cover A click ...

Page 13: ...rately 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: ...ace 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 detailed sto...

Page 15: ...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 ARKRAY Technical Customer Service 800 566 8558 24 hours a day 7 days a week The unit of measurement is fixed in mg dL and cann...

Page 16: ...tery is running low and 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 Connex Blood Glucose Meter Disp...

Page 17: ...ress 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 Press the or button to select YES and press the button to go to the next step NOTE Follow steps 2 3 to pair your meter and smartphone Pairing allows the meter to communicate wirelessly with your sma...

Page 18: ... app to create your account If you want to pair a new meter to an existing account in the ARK Care VITA app select Profile in the bottom right corner of the screen then select My Meters from the list and finally in the upper right of the screen 3 SMARTPHONE METER Enter the serial number found on the back of your GLUCOCARD Shine Connex Blood Glucose Meter into the ARK Care VITA app Enter only the 1...

Page 19: ...press the button when PAIr is blinking on the screen 1 The symbol and Pl n will appear on the screen 2 1 2 NOTE The symbol will appear on the screen when the Bluetooth feature is on When the symbol is not present on the screen the Bluetooth feature is off When you need to turn the Bluetooth feature on or off press the button when On or OFF blinks on the screen ...

Page 20: ...select Pair 3 METER When your meter and smartphone are paired connected the meter will display SUCCESS 4 METER When the data transfer is finished the meter will display End on the screen Press the button to go to Step 4 Setting the Year METER If the meter displays FAIL and then OFF repeat 2 4 in Step 2 and 1 2 in Step 3 SMARTPHONE If the ARK Care VITA app displays Unable to Sync select Try Again I...

Page 21: ... NOTE Some smartphones especially those that are not tested or approved by the manufacturer may NOT be compatible with your meter A list of compatible smartphones is available on the Apple App Store and Android Google Play ...

Page 22: ...m your selection and to go to the next step Step 5 Setting the Month A number 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 to go to the next step Step 6 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 confi...

Page 23: ...the Hour A number indicating the hour will blink on the screen Press the or button until the correct hour appears Press the button to confirm the hour and go to the next step Step 7 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 The AM PM symbol is not displayed in the 24 hour format After selecting the format pr...

Page 24: ...erted in the meter When the blood sample is absorbed into the test strip and the test starts When the test result is displayed When the button is pressed and held to set the post meal PP2 alarm When it is time for a preset blood glucose test Setting the Sound On OFF If the sound is set to OFF none of the sound functions will work After setting the sound press the button to progress to the next ste...

Page 25: ...E 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 This setting allows you to turn the test strip expiration date indicator On or OFF...

Page 26: ... the Hypoglycemia HYPo Indicator CAUTION Ask your healthcare professional to help you decide what your hypoglycemia level is before setting your hypoglycemia level NOTE If the test result is lower than the pre set hypoglycemia level the meter will display the following This setting allows you to turn the hypoglycemia indicator possible low blood sugar On or OFF and to select the desired level for ...

Page 27: ...ber indicating the year will blink in the left corner of the screen Press the or button until the correct year appears Press the button to confirm the year and go to the next step 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 a...

Page 28: ...the control solution bottle tightly and store at a temperature between 46 86ºF 8 30ºC Checking the System The GLUCOCARD Shine Connex Meter and GLUCOCARD Shine Blood Glucose Test Strips should be checked using GLUCOCARD Shine Control Solutions available in two levels Level 1 and 2 GLUCOCARD Shine Control Solutions contain known amounts of glucose and are used to check that the meter and test strips...

Page 29: ...ontrol solution test result by pressing the button for three 3 seconds To undo the control solution flag press the button for three 3 seconds again Use GLUCOCARD Shine Control Solution when You want to practice the test procedure using the control solution instead of blood You use the meter for the first time You begin using a new vial of test strips You suspect the meter or test strips are not wo...

Page 30: ...on absorbent 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 tu...

Page 31: ...played on the meter to the range printed on the test strip vial The test result should fall within the 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 ARKRAY 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 Shi...

Page 32: ... 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 1 or 2 drops 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 so...

Page 33: ... thick hard skin Choose a different site each time you test Using the Lancing Device Adjustable Tip Lancet Holder Charger Release Button Ejection System Lancet A lancing device is needed in order to collect a blood sample You may use the lancing device that is included in the GLUCOCARD Shine Connex Blood Glucose Monitoring System or any other medically approved lancing device The lancing device is...

Page 34: ...tep 2 Unscrew and remove the lancing device tip Step 3 Insert a new disposable lancet into the lancet holder Twist off the protective cover of the lancet and set it aside then replace the adjustable cap Keep the protective cover to replace on top of the used lancet after testing Preparing the Lancing Device ...

Page 35: ...e 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 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 sample size A beginning se...

Page 36: ... 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 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 s...

Page 37: ... 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 38: ...mitted data exists Step 9 At this time the display segments will rotate clockwise while the blood sample is going into the test strip The test result will appear after the meter 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 Disca...

Page 39: ...press the or button to select a Pre meal flag a Post meal flag a Fasting 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 Fasting flag Control solution flag ...

Page 40: ...ncet 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 ...

Page 41: ...en 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 low glucose levels If Lo is displayed again upon retesting please contact y...

Page 42: ...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 43: ...nce Diabetes Management System via a data cable The meter screen displays Pc when the data cable connects the meter with a computer For more information contact ARKRAY Technical Customer Service 800 566 8558 24 hours a day 7 days a week NOTE Test results can also be transferred to the ARK Care VITA mobile app wirelessly using Bluetooth To pair your meter and smartphone see pages 18 21 ...

Page 44: ...0 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 results and Fasting test results from the last 1 7 14 30 and 90 days The number of tests within the current day Step 2 Viewing Averages Press the but...

Page 45: ...ton to view 1 7 14 30 and 90 Day Average values and the number of tests performed post meals with the symbol for the last test period button button Post meal Average 1 7 14 30 90days button button Pre meal Average 1 7 14 30 90days Step 5 Viewing Fasting Averages Press the button to view 1 7 14 30 and 90 Day Average values and the number of tests performed during fasting with the symbol for the las...

Page 46: ...usa com Step 6 Use the button to scroll back through the averages seen previously Press the button to turn off the meter NOTE The control solution test results saved with the symbol are not included in the averages ...

Page 47: ...t Results Step 2 Use the button to scroll through the test results starting from the most recent and ending with the oldest Press the button to return to the result seen previously After checking the stored test results press and hold the button to turn off the meter The number of tests within the current day NOTE The control solution test results saved with symbol will be displayed with symbol wh...

Page 48: ...has been set will be displayed on the screen Four types of alarms can be set in the GLUCOCARD Shine Connex Meter one 1 post 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 wi...

Page 49: ... memory recall mode without the 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 Step 2 On pressing the button alarm1 is set and On is displayed on the screen Press the button again to cancel alarm1 OFF...

Page 50: ...button to set the hour Step 4 On pressing the button the number indicating the minute will start blinking Press the button to set the minute Step 5 Press the button to finish and to go to alarm2 setting Repeat steps 2 to 4 to set the remaining time alarms alarm 2 3 Step 6 Press the button for three 3 seconds to finish and turn the meter off ...

Page 51: ...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 Connex Meter is 5 years We rec...

Page 52: ...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 Connex 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 retail...

Page 53: ...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 54: ...he test strip vial See pages 29 31 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 ARKRAY Technical Customer Service 800 566 8558 24 hours a day 7 days a week The inscriptions on the exterior of the meter or lancing device have been removed The color of the meter or lancing dev...

Page 55: ...ION 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 ...

Page 56: ...pears before applying the blood or control solution sample The temperature during the test was above or below the operating range Move to an area where the temperature is within the operating range 42 8 111 2ºF 6 44ºC Repeat the test after the meter and test strips have reached a temperature within the operating range The blood sample has abnormally high viscosity or insufficient volume Repeat the...

Page 57: ...Y Technical Customer Service 800 566 8558 24 hours a day 7 days a week There is a problem with Bluetooth communication Contact ARKRAY Technical Customer Service 800 566 8558 24 hours a day 7 days a week An electronic error occurred during the test Repeat the test with a new test strip If the error message persists contact ARKRAY Technical Customer Service 800 566 8558 24 hours a day 7 days a week ...

Page 58: ...ted completely into the test strip port Check if the appropriate test strip was used Check whether the batteries are correctly inserted with the side facing up If the display is still blank 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 te...

Page 59: ...ose 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 60: ...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 61: ... 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 instructions o...