Arkray Glucocard Shine User Manual
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Arkray Glucocard Shine User Manual

Blood glucose monitoring system
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For single user / home use only

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Summary of Contents for Arkray Glucocard Shine

  • Page 1 User Manual For single user / home use only...

  • Page 2: Table Of Contents

    GLUCOCARD® Shine Blood Glucose Monitoring System Inserting or Replacing the Batteries GLUCOCARD® Shine Blood Glucose Test Strip GLUCOCARD Shine Blood Glucose Meter GLUCOCARD Shine Blood Glucose Meter Display Preparation Setting up Your System Adjusting the Date and Time Setting the Sound On/OFF...

  • Page 3: Important Information:read This First

    It 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 GLUCOCARD Shine Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.

  • Page 4: Important Health-Related Information

    The GLUCOCARD Shine Meter converts this electrical current to glucose concentration. • The GLUCOCARD Shine Blood Glucose 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.

  • Page 5: Specifications

    • 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 your healthcare professional or emergency medical response. Specifications • Product specifications Measurement range 20-600 mg/dL Sample size...

  • Page 6: Glucocard Shine Blood Glucose Monitoring System

    • 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.

  • Page 7: Inserting Or Replacing The Batteries

    Inserting or Replacing the Batteries The GLUCOCARD Shine 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 for the first time,the batteries should be replaced as soon as possible.

  • Page 8: Glucocard Shine Blood Glucose Test Strip

    GLUCOCARD Shine Blood Glucose Test Strip The GLUCOCARD Shine Blood Glucose Monitoring System measures blood glucose quickly and accurately. It automatically absorbs the small blood sample applied to the narrow edge of the strip. Contact bars Gently push the test strip, with its contact bars facing up, into the test...
  • Page 9 • The GLUCOCARD Shine Test Strip should be used only with fresh capillary whole blood samples. • Do not reuse test strips. • Do not use GLUCOCARD Shine Test Strips beyond the expiration date. This may cause inaccurate results. • Test strips in new, unopened vials and test strips in vials...

  • Page 10: Glucocard Shine Blood Glucose Meter

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

  • Page 11: Glucocard Shine Blood Glucose Meter Display

    GLUCOCARD Shine Blood Glucose Meter Display Test results: test results displaying panel Battery symbol: indicates meter battery is running low and needs to be replaced mem: appears when test results stored in the memory are displayed alarm: appears when the post-meal alarm has been set check: appears when test results have not been saved Hypoglycemia symbol: appears when the test result is below the hypoglycemic level Mute symbol: appears only when the sound is set to OFF...

  • Page 12: Setting Up Your System

    Setting up Your System Press and hold the >> button for 3 seconds to enter the set mode. After all settings are finished, press and hold the >> button for 3 seconds to turn off the meter. Press << to reach the accurate value. Press and hold << to scroll faster.
  • Page 13 Step 4 Setting the Date Press << until the screen displays the correct 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 <<...

  • Page 14: Setting The Sound On/Off

    Setting the Sound On/OFF Step 8 On pressing <<, the screen will display the “On” or “OFF”. Press the >> button to confirm the selection and move to the next mode. The meter will beep in the following instances, if set to On. •...

  • Page 15: Turn On The Strip Expiration Date Indicator

    Turn on the Strip Expiration Date Indicator Step 9 This mode allows you to turn the strip expiration date indicator on or off. When “EP” blinks on the screen, press <<. The screen will display “On” or “OFF”. Press the >> button to confirm the setting and move to the next mode.

  • Page 16: Turn On The Hypoglycemia (Hypo) Indicator

    Turn on the Hypoglycemia (HYPo) Indicator Step 10 This mode 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. When “Hypo”...

  • Page 17: Checking The System

    19-20 with two different levels 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...

  • Page 18: Control Solution Testing

    The symbol will be displayed on the screen. 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.
  • Page 19 Used strips should be discarded Level 2: 184-276 mg/dL safely in disposable containers. Caution: The ranges printed on the test strip vial are for the GLUCOCARD Shine Control Solutions only. They do not have any connection to your blood glucose level. 20 www.arkrayusa.com...

  • Page 20: Comparing The Control Solution Test Results

    Test Strip and Meter may not be working properly. Do not use your system and contact Customer Service, 800.566.8558. Note: The GLUCOCARD Shine Control Solution can be purchased separately. Contact Customer Service, 800.566.8558, 24 hours a day, 7 days a week, US and Canada.

  • Page 21: Using The Lancing Device

    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 Monitoring System or any other medically approved lancing device. Adjustable Tip Lancet Holder Ejection System Lancet Release Button...

  • Page 22: Preparing The Lancing Device

    Preparing the Lancing Device Step 1 Wash hands and the site from where the blood sample will be drawn thoroughly with warm soapy water. Rinse and dry. Step 2 Unscrew and remove the adjustable tip. Step 3 Insert a new disposable lancet firmly into the lancet holder.
  • Page 23 Step 4 The lancing device has five puncture depth settings, numbered 1 through 5. The smaller numbers are for a shallowerpuncture, 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 24: Preparing The Meter And Test Strip

    Flagging Post-meal Test Results The GLUCOCARD Shine Meter allows you to flag a result 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.

  • Page 25: Applying Blood Sample

    Applying the Blood Sample 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 device from the finger. Wait a few seconds for a blood drop to form.
  • Page 26 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: Discarding Used Lancets

    Discarding Used Lancets Step 1 Unscrew the lancing device tip. Step 2 Place the protective cover on the lancet. Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet in a proper biohazard container.

  • Page 28: Alternative Site Testing

    Alternative Site Testing What is AST (Alternative Site Testing)? Usually, when someone tests their glucose, they take the blood sample from the tip of the finger. However, since there are many nerve endings distributed there, it can be quite painful. When doing a glucose test, using different parts of the body, such as the forearms, palms, thighs, and calves, can reduce the pain during testing.
  • Page 29 Caution: AST results should never be used to calibrate Continuous Glucose Monitoring Systems nor entered into an insulin dosing calculator or pump for dosing recommendations. Things to know when using AST Please understand the following before testing at sites other than the fingertip (forearms, palms, thighs, and calves). The capillary whole blood of the fingertips shows changes in glucose levels more rapidly than from alternative sites.
  • Page 30 AST Precautions • Do not ignore the symptoms of hyperglycemia or hypoglycemia. • When the results of the test do not reflect the way you feel, retest using the fingertip. If the fingertip result still does not reflect the way you feel, please consult your healthcare professional.

  • Page 31: Hi And Lo Messages

    HI and Lo Messages 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 on retesting, please contact your healthcare professional immediately.

  • Page 32: Target Blood Glucose Ranges

    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 : The range of a normal fasting* blood glucose level for non-diabetic adults is between 70-99 mg/dL. Two (2) hours after a meal, the range of a normal blood glucose level for non-diabetic adults is between 100-139 mg/dL.

  • Page 33: Meter Memory

    Meter Memory 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, and post- meal test ( ) results from the last 1, 7, 14, 30 and 90 days.
  • Page 34 Step 3 Viewing Pre-meal Averages Repeatedly press the << to view 1-, 7-, 14-, 30- and 90-day average value and the number of tests performed pre-meals with the ‘Pr’ symbol for the last test period. << button Pre-meal average (1, 7, 14, 30, 90 days) >>...

  • Page 35: Viewing Test Results

    Viewing Test Results Step 1 Press << or the >> button to turn the meter on. The current date and time will be displayed on the bottom of the screen for 2 seconds, followed by the 1 day average value and the number of The number of the test results saved within the current tests...

  • Page 36: Setting The Post-Meal Alarm (Pp2 Alarm)

    Setting the Post-meal Alarm (PP2 Alarm) The PP2 alarm goes off 2 hours after setting the alarm. The alarms ring for 15 seconds and can be silenced by pressing << or the >> button or by inserting a test strip. Step 1 Setting the PP2 alarm On Without inserting a test strip, press and hold << for 3 seconds to set the post-meal alarm.

  • Page 37: Setting The Strip Expiration Date Indicator

    Setting the Strip Expiration Date Indicator 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.

  • Page 38: Caring For Your System

    Note: The life span of a GLUCOCARD Shine meter is 5 years. We recommend disinfecting both the meter and lancing device at least once per week. We have validated a total of 260 cleaning...
  • Page 39 • We have validated Clorox Germicidal Wipes with 0.55% sodium hypochlorite as the active ingredient for disinfecting the GLUCOCARD Shine Meter and lancing 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...
  • Page 40 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 Dispose of the used towelette in a trash bin. Pull out 1 new towelette and wipe the entire surface of the meter 3 times horizontally and 3 times vertically using a new...
  • Page 41 Repeat the same procedure for the lancing device (step to step * After the pre-cleaning and disinfection procedure, the control solution should be tested to confirm that the meter works properly before using the meter. Control solution tests should be performed with two different levels of solutions (Control Level 1 and 2). Verify that the test results are within the range printed on the test strip vial. See pages 19-20 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 Customer Service, 800.566.8558, 24 hours a day, 7 days a week, US and Canada.
  • Page 42 • Keep the meter away from strong electromagnetic field sources such as cell phones and microwave ovens. • The GLUCOCARD Shine Meter should be used only with GLUCOCARD Shine Test Strips. • Store all meter components in the carrying case to prevent loss.

  • Page 43: Understanding Error And Other Messages

    > Repeat the test using a new test strip. This error message may appear when the wrong blood glucose test strip is used instead of GLUCOCARD Shine blood glucose test strip. > Repeat the test with a GLUCOCARD Shine test strip.
  • Page 44 The temperature during the test was above 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 within the operating range.

  • Page 45: General Troubleshooting

    General Troubleshooting Problem Troubleshooting • Check whether the test strip is inserted with the contact bars facing up. Check if the strip has The display is blank been inserted completely into the even after inserting test strip port. a test strip. •...

  • Page 46: Performance Characteristics

    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.
  • Page 47 Precision: Precision studies were performed in a laboratory using the GLUCOCARD Shine System. Within Run Precision *Bloodavg. 39 mg/dL SD = 1.9 mg/dL *Bloodavg. 82 mg/dL SD = 2.7 mg/dL *Bloodavg. 145 mg/dL CV = 2.9% *Bloodavg. 179 mg/dL CV = 3.9% *Bloodavg.
  • Page 48 Alternative site test results for glucose concentration ≥ 75 mg/dL Within ± 5% Within ± 10% Within ± 15% Within ± 20% Fingertip 95/95 (100%) 95/95 (100%) 95/95 (100%) 95/95 (100%) Forearm 69/95 (72.6%) 91/95 (95.8%) 94/95 (98.9%) 95/95 (100%) Palm 61/95 (64.2%) 87/95 (91.6%)

  • Page 49: Warranty Information

    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 must return the defective meter or meter part along with proof of purchase to ARKRAY USA, Inc. 50 www.arkrayusa.com...

  • Page 50: Blood Glucose Monitoring System

    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. © 2014 ARKRAY USA, Inc. P/N 5146099 PGK7E0150 Rev010/2014...

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