MyGlucoHealth MGH-BT1 Operational Manual

MyGlucoHealth MGH-BT1 Operational Manual

Myglucohealth wireless meter
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M
G
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W
M
y
luco
ealtH
ireless
eter
o
M
perational
anual
mmol/L shown
mg/dL available
Model MGH-BT1
Rev 5-10.11

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Summary of Contents for MyGlucoHealth MGH-BT1

  • Page 1 Model MGH-BT1 Rev 5-10.11...
  • Page 2 Before using the MyGlucoHealth Wireless Meter for the first time, read all instructions in this manual and the additional information given in instructions for use of the test strips. Practice for accurate and safe testing.
  • Page 3 Custom Carrying Case note: Prior to use, check your MyGlucoHealth Kit to make sure that it is unopened and that it contains each of the parts shown above. If not, do not use your MyGlucoHealth meter and return it to where you pur-...
  • Page 4: Quick Reference

    QUICK REFERENCE With the meter turned OFF, Apply the blood sample until insert a MyGlucoHealth Test the confirmation window on Strip with the logo facing for- the strip is completely filled. ward and contact leads facing The meter will begin to count down.
  • Page 5 My- GlucoHealth Wireless meter use and application. QuickStart is a comprehensive video tool to take new users through all of the processes of setting up the MyGlucoHealth Wireless meter. Log on to www.myglucohealth.net/quickstart or press the Quick- Start button on the home page.
  • Page 6 PAIR/SEND - (up arrow only) Pair your meter and send test data using up arrow 1080800001 Blood Glucose Monitoring System : MGH-BT1/MGH-1 MODEL RATING: 3V 70mA For use with MyGlucoHealth test strips only! THIS DEVICE COMPLIES WITH PART 15 OF THE 6.
  • Page 7: Lcd Display

    Time Delete note: Before you use the MyGlucoHealth Wireless Meter to test your blood for the first time, practice the procedure using the MyGlucoHealth Control Solution. When you have completed three tests in a row that are within the expected range, you are ready to test your blood.
  • Page 8: Meter Accuracy

    89% of the time and within 7.5%, 100% of the time. When testing concentrations of greater than 4.2 mmol/L, MyGlucoHealth was within 5%, 65% of the time, within 10%, 92% of the time and within 15%, 98% of the time.
  • Page 9 Keep out of direct sunlight. Store MyGlucoHealth Test Strip vials in a cool, dry place between 36-86° F (2-30°C). Do not refrigerate or freeze. Make a notation of the discard date on the vial label when you first open it.
  • Page 10: Initial Meter Set Up

    INITIAL METER SET UP ettinG eter Time, date and alarm settings for the MyGlucoHealth Wireless meter must be set when the unit is initially turned on. oWer Press and hold the CENTER/POW- button for at least 3 seconds until the year starts flashing.
  • Page 11 INITIAL METER SET UP veraGes The date average function creates 3 time periods in days where all test results taken in the time period are averaged and then displayed (7 day average shown). To set the number of days for the time period desired, press and re- lease either UP or DOWN button then press the CENTER/POWER...
  • Page 12 Always insert the test strip with the MyGlucoHealth Wireless meter turned OFF. Without setting the date properly, the average glucose level and the results in memory will not show the proper values. You must set the meter before use and confirm the date is correct when new batteries are installed.
  • Page 13 Make sure you have all the necessary items to begin testing: MyGlucoHealth Wireless Meter MyGlucoHealth Test Strip Lancing Device Sterile Lancet note: The lancing device and sterile lancets should NOT be shared with others.
  • Page 14: Lancing Device

    The instructions for collecting a drop of blood in Steps 1 through 5 relate to the MyGlucoHealth Lancing Device that is included in the meter kit. If using another lancing device, read and follow instructions supplied with that device.
  • Page 15 The MyGlucoHealth Wireless meter offers the option of Al- ternate Site Testing by taking blood samples from the upper arm, forearm, hand, palm, thigh or calf. See pages 41-42 for information on alternate test sites if approved by your doctor.
  • Page 16 The MyGlucoHealth Wireless Meter features Auto Coding of Test Strips. When a test strip is properly inserted, the meter automati- cally recognizes the code number and sets the meter accordingly. This prevents input and testing errors.
  • Page 17 Incorrect test strip insert direction With the meter turned OFF; insert a MyGlucoHealth Test Strip into test port on the top of the meter. Insert the strip with the MyGluco- Health logo facing you and the contacts down. Do not insert the test strip upside down.
  • Page 18 TAKING A BLOOD TEST 2 - l ance and pply lood rop to trip ncorrect orrect Partially filled Completely filled Using the lancing device, lance your fingertip and draw a small drop of blood. Gently place your fingertip on the top edge of My- GlucoHealth Test Strip.
  • Page 19 If the code on the LCD display window and on the test vial does not match, try a new strip. If the mismatch per- sists, contact the MyGlucoHealth Customer Care Hot- line at +1 877 458 2646 or +1 619 684 6232 for help.
  • Page 20: Testing Your Blood

    You can send your test results to the MyGlucoHealth Portal di- rectly from your computer using Bluetooth or USB or by using the MyGlucoHealth Mobile App refer to the “MyGlucoHealth Portal Overview” beginning on page 22.
  • Page 21: Reviewing Previous Results

    The MyGlucoHealth Wireless Meter saves up to 250 test results in its internal memory and records the average glucose level for a preset number of days (ie. 7, 14, 21). These values can be re- called in the LCD display window at any time. The newest results will overwrite the oldest, after 250 tests are stored.
  • Page 22 MYGLUCOHEALTH PORTAL OVERVIEW MyGlucoHealth Portal Secure Patient Log In Automated Data Uploads MyGlucoHealth is an intel- ligent diabetes management platform providing compre- hensive tools for patients, clinicians, families and care- givers to improve lives and lifestyles.
  • Page 23 MyGlucoHealth Wireless works in combination with a real time online data collection network to upload and report patient blood glucose readings. Using the MyGlucoHealth Portal at www.my-...
  • Page 24 MYGLUCOHEALTH PORTAL OVERVIEW The MyGlucoHealth Portal is an extensive communication and data management web site that provides an easy-to-use interface for automatically collecting test results from the meter. Stored results are wirelessly transmitted by mobile phone or PC to the Portal for posting.
  • Page 25 MYGLUCOHEALTH PORTAL OVERVIEW The MyGlucoHealth Portal allows patients to automatically send themselves or their care team alerts and reminders about their changing condition or to remind them to test or take medication. Alerts and reminders can be sent by email or SMS text message.
  • Page 26 “r ”. eGister Upon receipt of your MyGlucoHealth Wireless Meter kit, you are invited to register for a subscription to the MyGlucoHealth Portal and mobile application. To do this, enter the serial number located on the back of the me- ter along with your email address.
  • Page 27 USB. MyGlucoHealth USB Cable note: Use of the MyGlucoHealth Portal or mobile application re- quires subscription to the online service, charges may apply. Consult your mobile phone carrier for data charges related to the upload and use of any mobile services.
  • Page 28 Once the driver(s) are installed, you are ready to upload readings. Press the “Get Readings” button again and the MyGlucoHealth upload program will start up. The first screen you will see is “Con- nection Settings”. Enter your Member ID and password. Select your preferences, language, units of measure and date format.
  • Page 29 Portal. The progress bar will indicate when re- cords are being uploaded. After the last test result is displayed on your screen, press “Continue” to return to your secure re- cords site on the MyGlucoHealth Portal. 4 - d leep Mode When you unplug the USB cable from your meter, the meter will go into sleep mode and the LCD display will turn off.
  • Page 30 This will open the “Add Blue- tooth Device Wizard.” Add Bluetooth Device Wizard note: Screen images and Control Panel settings may vary slightly depending on computer operating system and web browser. MyGlucoHealth is optimized for most current operating sys- tem/browser combinations.
  • Page 31 ENTER the pairing PIN number (0000) in the window that opens up on your PC. 3 - p aired onnected When the MyGlucoHealth Wireless Meter is paired with your PC, the LCD window on the Meter will display “P” to confirm the paired status. (Fig #2) 4 - s leep...
  • Page 32 If the posting pro- cess fails, move to a different location and try again. Contact MyGlucoHealth Customer Care Hot- line on +1 877 458 2646 or +1 619 684 6232 or email support@myglucohealth.net if posting repeatedly fails.
  • Page 33 The test results from your meter will au- tomatically post to the Portal. After the last test result is displayed on the screen, press “Contin- ue” to return to your secure account on the MyGlucoHealth Portal. 3 - d leep Mode...
  • Page 34 Most mobile phones are paired by going into the mobile phone’s settings and enabling Bluetooth, then selecting “Pair New De- vice.” The name of the meter will appear as “myglucohealth” on your mobile phone as a paired Bluetooth device. note: When you set up your membership account on the mygluco- health.net web site you can request an SMS message that...
  • Page 35 PAIRING METER TO MOBILE PHONE airinG eter oBile Hone Figure #1 Figure #2 1 - B eGin WitH oBile Hone Turn your phone ON. Enable Bluetooth by accessing your phone’s Network or Connectivity settings. While every phone is slightly different, this is where to start. If you don’t know how to turn on Bluetooth or aren’t sure whether your phone supports Bluetooth, refer to your phone’s user guide.
  • Page 36 MYGLUCOHEALTH MOBILE APP The MyGlucoHealth Mobile App allows users to upload results seamlessly to the web, as well as review and evaluate results on their mobile phone. MyGlucoHealth is compatible with most major mobile phone manufacturers and mobile carri- ers worldwide.
  • Page 37: Mobile App

    When you set up your membership account on the mygluco- health.net web site you can request an SMS message that will send you a link to download the MyGlucoHealth Mobile App to your phone. Input your mobile phone number and the system will send you a link to activate the application and set it up on your phone.
  • Page 38 4 – B luetootH airinG Unless you have already Paired your Mobile Phone to the MyGlucoHealth Wireless meter using Bluetooth, the Mobile App will identify the Meter and Pair the two. Follow the on-screen in- structions with your MyGlucoHealth...
  • Page 39 POSTING DATA VIA MOBILE PHONE ostinG esults sinG oBile Hone Posting test results to the MyGlucoHealth Portal via a mobile phone is done using the MyGlucoHealth Mobile App. 1 – l auncH tHe oBile on your Hone Press Menu on your phone to find your personal Applications.
  • Page 40 Portal. You will see your last result on your mobile phone screen. The MyGlucoHealth Wireless meter will enter sleep mode after all of the data is successfully uploaded. You can then navigate to the portal or back to the applications to view other features using the...
  • Page 41 ALTERNATE SITE TESTING The MyGlucoHealth Wireless me- Upper Arm ter offers the option for alternate site testing by taking blood sam- Forearm ples from the upper arm, forearm, Hand hand, palm, thigh or calf. Using al- Palm (Dorsal) ternate sites gives the user more...
  • Page 42 ALTERNATE SITE TESTING Mportant nforMation Bout lternate estinG Consult your physician before testing at alternative sites. Testing during or after a meal, physical exercise or any other event that will impact glucose levels can alter your blood glucose test re- sults.
  • Page 43 Dispose of used testing materials in accordance with local regula- tions for contaminated materials. The MyGlucoHealth Wireless Meter may be sent back to the manu- facturer for recycling or proper disposal after its useful life. Alterna- tively the meter may be disposed of in accordance with local laws.
  • Page 44: Replacing Batteries

    Wireless Meter will not power ON when the battery power is ex- hausted. The MyGlucoHealth Wireless Meter uses two 1.5V alkaline bat- teries (AAA size). The first set of batteries is included with the meter in the meter kit. When replacing the batteries, use only 1.5V AAA equivalent alkaline batteries.
  • Page 45 Try a new test strip. If Er3 display Problem with persists, call the MyGlucoHealth the test strip Customer Care Hotline at +1 877 458 2646 or +1 619 684 6232 or email support@myglucohealth.
  • Page 46 TROUBLE SHOOTING Message Problem Action Required Re-test with new test strip Problem with test strip Repeat the test with new test The blood strip. Apply blood only after the sample was test strip symbol appears applied before on the display. the test symbol Be sure to press the CENTER/ appeared on the...
  • Page 47 Change the batteries and if the Batteries are not power on problem persists, call the MyGlu- dead or there is coHealth Customer Care Hotline a problem with on +1 877 458 2646 or +1 619 the meter. 684 6232 or email support@ myglucohealth.net.
  • Page 48 If you continue to get unexpected test results, check your meter and test strip using control solution. If meter is not functioning properly, call the MyGlucoHealth Customer Care Hotline on +1 877 458 2646 or +1 619 684 6232 or email sup- port@myglucohealth.net.
  • Page 49: Meter Specifications

    METER SPECIFICATIONS Sample Type Capillary Whole Blood Sample Volume 0.3 µL Test Range 10-600 mg/dL (0.6-33.3 mmol/L) Reading Time 3 seconds Meter Memory 250 tests Calibration Auto Coding, Plasma Calibrated Altitude Sea Level up to 10,000 ft. (3048 m) Operating Temp. 50°- 104°F (10 - 40°C ) Operating Humidity 10 - 90%...
  • Page 50 SYMBOLS Symbol Description Consult operating instructions Expiration Date This product fulfills the requirements of Directive 98/79/EC on in vitro diagnostic medical devices Caution, consult accompanying documents In-vitro Diagnostics Batch Code Storage Temperature Do not re-use Use within 3 months after first opening Date Manufactured Electrical waste and electronic equipment Keep away from sunlight...
  • Page 51 Glucose enzyme oxidase on the MyGlucoHealth test strip reacts with blood glucose detected in the blood sample. Electrical current is gen- erated and measured and the result is displayed as the blood glucose level on the meter.
  • Page 52 BLOOD GLUCOSE CONVERSION lood lucose onversion aBle mmol/L 0.55 1.0 0.55 1.0 mg/dL mmol/L 3.3 3.9 4.0 4.4 4.7 5.0 5.5 6.0 3.3 3.9 4.0 4.4 4.7 5.0 5.5 6.0 90 100 108 110 90 100 108 110 mg/dL mmol/L mg/dL 120 126 130 135 140 145 150 160 120 126 130 135 140 145 150 160...
  • Page 53 EC DECLARATION OF CONFORMITY...
  • Page 54 EC DECLARATION OF CONFORMITY...
  • Page 55 Bluetooth function (For self testing only). Declaration of Conformity (DoC) Entra Health Systems declares that this MyGlucoHealth (Blood Glucose Monitoring System) is in compliance with the essential requirements and other relevant provisions of Directive 98/79/EC.
  • Page 56: Warranty And Support

    The toll free MyGlucoHealth Customer Care Hotline is +1 877 458 2646 or +1 619 684 6232. This line is available from 8am to 5pm Pacific Time, Monday through Friday. Outside these hours, leave a message or send an email to support@myglucohealth.net. Cus- tomer Support will respond within 2 hours on voice messages or emails received during normal business hours.
  • Page 57 BeloW Serial Number Member ID/E-mail Address Password The serial number for your luco ealtH MyGlucoHealth Wireless meter is ustoMer otline located on the back of your meter +1 877-458-2646 at the top. You’ll need your serial +1 619 684 6232...
  • Page 58 3111 Camino del Rio North, Suite 101 San Diego, California USA 92108 +1 877 458 2646 +1 619 684 6232 www.entrahealthsystems.com www.myglucohealth.net support@myglucohealth.net Certain pictures shown in this book are for illustrative purposes only and are subject to change without notice. Rev 5-10.11...

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