Arkray GLUCOCARD Shine Connex User Manual
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Arkray GLUCOCARD Shine Connex User Manual

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  • Page 1 User Manual For single user / home use only...
  • Page 2 24 hours a day, 7 days a week. Minneapolis, MN 55439 U.S.A. In case of emergency, please 800.566.8558 contact your healthcare www.arkrayusa.com professional or emergency medical response. P/N 5524-01 Rev. 04/19 © ARKRAY USA, Inc. PGUAA-0000033 REV1 04/2019 All Rights Reserved.
  • Page 3 Welcome to the GLUCOCARD® Shine Connex Blood Glucose Monitoring System Thank you for choosing the GLUCOCARD Shine Connex Blood Glucose Monitoring System. The system provides you with rapid 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 µL) blood sample.
  • Page 4 WARNING Turn off the Bluetooth® feature in areas where the use of wireless devices is restricted, such as hospitals, some healthcare professional offices, and airplanes. Trademarks The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth® SIG, Inc. and any use of such marks by the manufacturer is under license.

  • Page 5: Table Of Contents

    Table of Contents Information Important Information: Read This First - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Important Safety Information - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Limitations of GLUCOCARD®...
  • Page 6 Important Information: Read This First Intended use • The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. • The GLUCOCARD Shine Connex Blood Glucose Monitoring...
  • Page 7 • GLUCOCARD Shine Blood Glucose Test Strips are intended for single use only. They should be disposed 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.
  • Page 8 • Not for use on critically ill patients. • Not for use on anyone undergoing oxygen therapy. • For in vitro diagnostic use only. • The GLUCOCARD Shine Connex Blood Glucose Meter should only be used with GLUCOCARD Shine Blood Glucose Test Strips.
  • Page 9 This device is not intended for use in healthcare or assisted- use settings such as hospitals, physician offices or long-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.
  • Page 10 Specifications Product specifications Measurement range 20–600 mg/dL Sample size Minimum 0.5 μL 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 1,000 test results Size...

  • Page 11: Glucocard Shine Connex Blood Glucose Monitoring System

    GLUCOCARD Shine Connex Blood Glucose Monitoring System GLUCOCARD Shine Connex Blood Glucose Monitoring System includes the following items:  GLUCOCARD Shine Connex Blood Glucose Meter  User Manual  Quick Reference Guide  Bluetooth® Pairing Quick Guide  Batteries (2) ...
  • Page 12 Inserting or Replacing the Batteries • The GLUCOCARD Shine Connex 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 while the meter is in use, the batteries should be replaced as soon as possible.

  • Page 13: Glucocard Shine Blood Glucose Test Strip

    GLUCOCARD Shine Blood Glucose Test Strip The GLUCOCARD Shine Connex Blood Glucose Monitoring System measures blood glucose quickly and accurately. 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 meter.
  • Page 14 Warning • GLUCOCARD Shine Blood Glucose Test Strips should only be used with fresh capillary whole blood samples. • Do not reuse test strips. • Do not use test strips past the expiration date. • When test strips are used and stored according to correct storage and handling methods, both new, unopened vials and vials that have been opened can be used until the expiration date printed on the test strip box and vial label.

  • Page 15: Glucocard Shine Connex Blood Glucose Meter

    GLUCOCARD Shine Connex Blood Glucose Meter Data Port Display Used to transfer data Shows results from the meter to a and messages computer with a cable <, > Button Button Turns the meter Turns the meter on, selects on/off, confirms...

  • Page 16: Glucocard Shine Connex Blood Glucose Meter Display

    GLUCOCARD Shine Connex Blood Glucose Meter Display Memory recall mode: appears when test results stored in the memory are displayed PP2 Alarm: appears when the post- meal alarm has been set Bluetooth® symbol: appears when Bluetooth® is turned on Mute symbol: appears only when the...

  • Page 17: Setting Up The Glucocard Shine Connex System

    Setting Up the GLUCOCARD Shine Connex System Meter settings, such as time and date, should be checked and updated before using the meter or after changing the meter batteries. Press and hold the button for three (3) seconds to enter ‘SET’...
  • Page 18 ‘+’ in the upper right of the screen. 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 12-character serial number. See example below.
  • Page 19 METER: Press the < or > button. The meter screen will first display ‘OFF’, then ‘On’ and finally ‘PAIr’. To pair (connect) your meter to your smartphone, press the button when ‘PAIr’ is blinking on the screen (1). symbol and ‘Pl n’ will appear on the screen (2).
  • Page 20 Step 3 Entering the PIN Number SMARTPHONE: Follow the steps displayed on the ARK Care VITA app after entering in the meter's serial number. METER/SMARTPHONE: The meter will now display a 6-digit PIN code. Enter this PIN code into the ARK Care VITA mobile app and select ‘Pair’.
  • 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. www.arkrayusa.com 21...
  • Page 22 Adjusting the Date and Time Step 4 Setting the Year A number indicating the year will blink on the screen. Press the < or > button to adjust until the correct year appears. After setting the year, press the button to confirm your selection and to go to the next step.
  • Page 23 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, press the button to go to the next step.
  • Page 24 Setting the Sound On/OFF Step 10 On pressing the < or > button, the screen will display 'On' or 'OFF'. Press the button to confirm the selection. The meter will beep in the following instances if set to 'On': • When a button is pressed to turn on the meter. •...

  • Page 25: Turning On The Test Strip Expiration Date Indicator

    Turning on the Test Strip Expiration Date Indicator This setting allows you to turn the test strip expiration date indicator 'On' or 'OFF'. This setting turns the function 'On' or 'OFF' only. See page 27 to set the test strip expiration date. Step 11 When 'EP' appears on the screen, press the <...

  • Page 26: Turning On The Hypoglycemia (Hypo) Indicator

    Turning on the Hypoglycemia (HYPo) Indicator This setting allows you to turn the 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.

  • Page 27: Setting The Test Strip Expiration Date Indicator

    Setting the Test Strip Expiration Date Indicator Step 1 Entering the Expiration Date Setting Press and hold the < and > buttons at the same time for three (3) seconds to enter the expiration date settings. After all segments flash across the screen, 'EP' will show up. NOTE •...
  • Page 28 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 are working properly.
  • Page 29 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. •...
  • Page 30 Step 3 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. Wipe the tip with a clean tissue or cloth. Dispense a drop of control solution onto a clean non-absorbent surface.
  • Page 31 Shine Control Solutions only. It has nothing to do with your blood glucose level. 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. www.arkrayusa.com 31...

  • Page 32: Comparing The Control Solution Test Results

    If results continue to fall outside the range printed on the test strip vial, the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Connex Meter may not be working properly. Do not use your system and contact ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week.
  • Page 33 Using the Lancing Device 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. Adjustable Tip...
  • Page 34 Preparing the Lancing Device Step 1 Wash hands and sample site with soap and warm water. Rinse and dry thoroughly. Step 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.
  • Page 35 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 the adjustable tip until the setting number matches the arrow.
  • Page 36 Preparing the Meter and Test Strip 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.
  • Page 37 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.
  • Page 38 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.
  • Page 39 Step 10 You can attach a flag to a test result to indicate particular situations while the test strip is still in the meter. When the result is displayed right after a test, press the < or > button to select a Pre-meal flag ( ), a Post-meal flag ( ), a Fasting flag (...
  • Page 40 Discarding Used Lancets Step 1 Unscrew the adjustable cap from the lancing device. Step 2 Place the protective cover on the lancet. Remove lancet and dispose of the used lancet in a proper biohazard container. CAUTION • Check for damage before using the lancet. If it has been damaged, please discard it and use another lancet.
  • Page 41 (very low glucose levels). If ‘Lo’ is displayed again upon retesting, please contact your healthcare professional immediately. NOTE • If the message persists, please contact ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week. www.arkrayusa.com 41...
  • Page 42 Target Blood Glucose Ranges Reminders Your target ranges from your healthcare professional Time of day Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 a.m. and 4 a.m. Expected Values: Normal blood 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.
  • Page 43 Transferring Test Results Test results stored in GLUCOCARD Shine Connex Blood Glucose Meter can be transferred from the meter to the desktop version of ARK Care Advance Diabetes Management System via a data cable. The meter screen displays ‘Pc’ when the data cable connects the meter with a computer.
  • Page 44 Meter Memory The GLUCOCARD Shine Connex 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.
  • Page 45 Step 3 Viewing Pre-meal Averages Continue to press the < < button button to view 1-, 7-, 14-, Pre-meal 30- and 90-Day Average Average values, and the number of (1, 7, 14, 30, tests performed pre-meals 90 days) with the symbol for the last test period.
  • Page 46 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. 46 www.arkrayusa.com...
  • Page 47 Viewing Test Results Step 1 Press any button to turn the meter on. The current date and time will be displayed on the bottom of the screen followed by the 1-Day Average value and the number of the test results saved within the current day.
  • Page 48 Setting the Alarm Function 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. •...
  • Page 49 Step 2 Turning the PP2 Alarm OFF To turn off the PP2 Alarm, press and hold the < button for three (3) seconds. ‘PP2’, the symbol, and ‘OFF’ will appear on the screen. Then the screen will change automatically to the memory disappears recall mode without the symbol displayed.
  • Page 50 Step 3 Press the < button to adjust the time of ‘alarm1’. A number representing the hour will blink on the screen. Press the > button to set the hour. Step 4 On pressing the < button, the number indicating the minute will start blinking. Press the >...

  • Page 51: Caring For The Glucocard Shine Connex System

    • 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 recommend disinfecting both the meter and lancing device at least once a week. We have validated...
  • Page 52 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.
  • Page 53 Pre-cleaning and Disinfection Procedures 1 Open the cap of the Clorox® Germicidal Wipes container and pull out one (1) towelette and close the cap. 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 Front...
  • Page 54 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.
  • Page 55 • Store all meter components in the carry case to prevent loss and to help keep the meter clean. NOTE • For additional information or technical assistance contact ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week. www.arkrayusa.com 55...
  • Page 56 Understanding Error Messages Message What it means What to do A used test strip was Repeat the test with a inserted. new test strip. The blood or control Repeat the test with a solution sample was new test strip and wait applied before the until the symbol...
  • Page 57 ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week. NOTE • If the error messages persist, contact ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week. www.arkrayusa.com 57...
  • Page 58 • Check the expiration date of the test strip. • Perform control solution test. NOTE • If the problem is not resolved, please contact ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week. 58 www.arkrayusa.com...
  • Page 59 Monitoring System has been evaluated in laboratory and in clinical tests. Accuracy The accuracy of the GLUCOCARD Shine Connex Blood Glucose Monitoring System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument.
  • Page 60 48 mg/dL and 553 mg/dL. Within ± 15 mg/dL and Within ± 20% 371/371 (100%) Precision Precision studies were performed in a laboratory using the GLUCOCARD Shine Connex Blood Glucose Monitoring System. Within Run Precision Blood avg. 43 mg/dL SD = 1.9 mg/dL CV = 4.3%...
  • Page 61 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 ARKRAY Technical Customer Service: 800.566.8558, 24 hours a day, 7 days a week.

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