BioTel Care BGM User Manual
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BioTel Care BGM User Manual

Blood glucose monitoring system
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Blood Glucose
Monitoring System
User Manual
This product contains a rechargeable internal battery. To conserve
battery power this product will turn off the screen after one
minute of non-use. To turn on the product either insert a test strip
or press any side button.
Not Intended for Sale Within the EU
Contents
A
Intended Use (pg. 2)
B
Important Safety Instructions (pg. 2)
C
Getting Started (pg. 3)
D
D.1 Testing Your Blood Glucose (pg. 10)
D.2 Testing With Control Solution (pg. 17)
D.3 Functions and Settings (pg. 21)
E
Classic Mode (pg. 31)
E.1 Testing Your Blood Glucose (pg. 32)
E.2 View Your History on the Meter (pg. 35)
E.3 Testing With Control Solution (pg. 35)
E.4 Setting Up Your BioTel Care BGM™ (pg. 39)
F
Maintenance of Your BioTel Care BGM™
and Lancing Device (pg. 40)
G
Storing Your BioTel Care BGM™ and Test Strips (pg. 45)
H
I
J
Terms of Service/Use (pg. 55)
K Privacy Policy (pg. 69)
ART-161 Rev. 6
TM
1

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Summary of Contents for BioTel Care BGM

  • Page 1: User Manual

    E.4 Setting Up Your BioTel Care BGM™ (pg. 39) Maintenance of Your BioTel Care BGM™ and Lancing Device (pg. 40) Storing Your BioTel Care BGM™ and Test Strips (pg. 45) Troubleshooting (pg. 45) About Your System (pg. 50) Terms of Service/Use (pg. 55)
  • Page 2 Test results are plasma-calibrated for easy comparison to clinical laboratory methods. Testing is done outside the body (in vitro diagnostic use). The BioTel Care Blood Glucose Monitoring System consists of the BioTel Care Blood Glucose Meter, BioTel Care...
  • Page 3 Thank you for choosing the BioTel Care Blood Glucose Monitoring System. The BioTel Care system is comprised of the BioTel Care meter and the online website. The meter provides accurate readings sent immediately to your online account to store, track, and chart.
  • Page 4 You should use the BioTel Care BGM for: • Testing Blood Glucose • Testing only with fresh capillary whole blood samples You should NOT use the BioTel Care BGM for: • The diagnosis of Diabetes • Testing blood glucose on newborn infants •...
  • Page 5 D. Your BioTel Care BGM      This is a Touch Screen   Left side Right side  Back button Info button  Home button   Power (PWR) Button • Short-press of power button turns on/off the screen.
  • Page 6 • Do not use wet or damaged test strips. Preparation and Safety Before you begin, make sure to: • Set up your BioTel Care BGM Blood Glucose Meter properly. • Run a control test before first use. (See Step-by-Step Guide to Control Testing - pg.
  • Page 7 6 months after the date of opening. • Do not operate the meter outside the temperature range of 50°F (10°C) to 104°F (40°C). • The BioTel Care BGM is compatible with Telcare® Test Strips and Telcare® Glucose Control Solutions. You will need: •...
  • Page 8 The Home Screen    On the Home Screen, you can see the following:   Wireless Signal Strength  Battery Level   Current Time  Last Test Reading  Date and Time of Last Reading In this Home Screen, swipe up/down OR use the UP/ DOWN buttons (located on the left of your meter)
  • Page 9 Icon Definitions Symbol Descriptions The name of the cellular carrier to which Carrier Name the meter is currently connected. Indicates that the current battery charge status. The battery energy remaining is depicted in a standard manner, familiar to most users, in which red indicates near-total discharge, which additional levels of white indicate progressively more complete charge states.
  • Page 10 Home Screen. 2. Press on the TEST MODE icon OR use the three buttons on the left side of the BGM to enter BG Test Mode. When ready to check blood, Insert a new test strip will be displayed.
  • Page 11 3. Take out a BioTel Care Test Strip from the bottle, AUTOLET PLUS COMPONENTS and close the bottle a. Depth adjuster immediately. (Some meters b. Depth setting indicator window require the user to enter a c. Activation button code from the vial. BioTel d.
  • Page 12 Blood Glucose Monitoring System to obtain a blood sample. The minimum blood sample volume is 0.8 microliters. • Purchase an additional BioTel Care Lancing Device by calling Telcare, LLC at (888) 666-4530 (US) or (1) (978) 610-4688 (International). (9AM - 9PM EST, M-F).
  • Page 13 If you require one, please contact Telcare, LLC. Important Information on Alternate Site Testing You BioTel Care BGM capable of testing your blood glucose from your palm, usually referred to as an alternate site test, or AST.
  • Page 14 Alternate site testing can be less painful than fingertip testing. However, because of the physiological differences between your fingertip and palm, AST results may be significantly different. Alternate site testing should not be used to calibrate a continuous glucose monitor nor should it be used in insulin dose calculations.
  • Page 15 “No tag”. 9. Sending Your Results After pressing the CONTINUE button, your BioTel Care BGM will send the results to Telcare’s secure server. 10. Remove the used test strip and discard it properly.
  • Page 16 Important steps to follow if you see High or Low If you see High or Low displayed, your blood glucose level may be above 600 mg/dL or below 20 mg/dL. Wash your hands. Dry your hands completely. Test again using fingertip testing. DO NOT test on your palm or forearm.
  • Page 17 1. American Diabetes Association. Standards of Medical Care in Diabetes— 2008. Diabetes Care. 2008;31:S12–S54. D.2 Testing With Control Solution Control solution testing will confirm that your BioTel Care BGM and Test Strips are working properly. You should perform control solution testing when: •...
  • Page 18 2. Press on the TEST MODE icon OR use the three buttons on the left side of the BGM to enter Test Mode. Switch modes from Normal Test Mode to L1 Control Solution Mode. To test Level 1 (L1) control...
  • Page 19 Again, press on the TEST MODE icon OR use the three buttons on the left side of the BGM to enter Test Mode. Switch modes from Normal Test Mode to L2 Control Solution Mode. To test Level 2 (L2) control solution,...
  • Page 20 Control Solution readings are stored on the meter but are not included in the Blood Glucose testing logs. Important Tips About Control Solution 1. Only use BioTel Care or Telcare® Glucose Control Solution with the BioTel Care or Telcare® Test Strips. Other brands of control solution or test strips may produce inaccurate results.
  • Page 21 Your BioTel Care BGM can store a lifetime of logs. Each log is stored with date and time. 1. Power on the BioTel Care BGM using the PWR button. 2. Press on the LOGS icon OR use the UP/DOWN /ENTER buttons to access logs.
  • Page 22 Blood Pressure, A1C. Each category has its unique icon as shown in the picture. Add Logs on the Meter Add your logs on your meter Your BioTel Care BGM allows you to manually add Blood Glucose, Carbs, Medicine, Activity, Weight, Blood Pressure and A1C.
  • Page 23 4. You can enter the log details such as amount, tag and timestamp and press SUBMIT to save and upload this log to the server. 5. Create New Log Type You can enter the Create New Log Type screen by pressing the New Log Type button, where you can enter new type name and unit.
  • Page 24 View Messages Display messages on your meter Your BioTel Care BGM allows you to check historical messages. The messages will be displayed in chronological order with most recent at the top. 1. You can enter the Message Screen from the Home Screen by swiping up and pressing the MESSAGES icon or use the buttons to select and enter.
  • Page 25 1. You can enter the Summary Screen from the Home Screen by swiping up and pressing the SUMMARY icon or use the buttons to select and enter. 2. You can swipe left/right, press the “<” and “>” icons OR use the UP/DOWN buttons to navigate to each graph.
  • Page 26 Reminders Your BioTel Care BGM allows you to create and manage reminders for blood glucose readings, medications or activities, etc. 1. You can enter the Reminders Screen from the Home Screen by swiping up and pressing the REMINDERS icon or use the buttons to select and enter.
  • Page 27 Support Get on-screen support from your tutorials on your meter. Your BioTel Care BGM allows you to view video tutorials and the user manual on your meter. 1. You can enter the Support Screen from the Home Screen by swiping up and pressing the SUPPORT icon or use the buttons to select and enter.
  • Page 28 If you would like to view your meter’s preset settings, navigate to the Settings screen. Navigating to the Settings Screen 1. Power (PWR) your BioTel Care BGM device on. 2. Swipe up OR use the DOWN button to navigate to the Settings option.
  • Page 29 Setting Options Volume Change the volume of your meter by moving the slider thumb. Brightness Change the brightness of your meter’s screen. Airplane Mode Turning on Airplane Mode disables cellular network access. You will not be able to transmit your readings while Airplane Mode is turned on.
  • Page 30 Your BioTel Care BGM allows you to download software updates available for your BGM from the App Store. You can enter the Apps Screen from the Home Screen by swiping up and pressing the APPS icon or use the buttons to select and enter.

  • Page 31: Main Menu

    Non-Critical Updates When a non-critical software update is available, an INSTALL NOW or TRY LATER prompt will appear on your screen. The INSTALL NOW prompt will take you to the App Store to select and install the update. The TRY LATER prompt will display the software update prompt again after 24 hours, until the update has been completed.
  • Page 32 (Some meters require the user to enter a code from the vial. BioTel Care and Telcare® strips do not require a code.) 3. Firmly insert the test strip into your BioTel Care BGM until it is fully seated. 4. Prepare Your Lancing Device*...
  • Page 33 “No tag”. 9. Sending Your Results As soon as you select the tag, your BioTel Care BGM™ will send the results to Telcare’s secure server. *Please see details in Section D.1 - Testing Your Blood Glucose...
  • Page 34 10. You can remove the test strip. Discard the used test strip properly. Important steps to follow if you see High or Low If you see High or Low displayed, your blood glucose level may be above 600 mg/dL or below 20 mg/dL. Wash your hands.
  • Page 35 “BACK” (Shortcut: Press the BACK button.) E.3 Testing With Control Solution Control solution testing will confirm that your BioTel Care and Test Strips are working properly. You should perform control solution testing when: • Using the meter for the first time •...
  • Page 36 Upon successful completion of Level 1 (L1), test Level 2 (L2) control solution: Again use the UP/DOWN keys on the left side of the BGM to access the main menu. Switch modes from Normal Test Mode to L2 Control Solution Mode.
  • Page 37 • Firmly insert the test strip into your BioTel Care BGM until it is fully seated. • The term “BioTel Care” or “Telcare” should be facing up. • The sample tip should be facing up. • Continue to push the strip in until •...
  • Page 38 Important Tips About Control Solution 1. Only use BioTel Care Glucose Control Solution with the BioTel Care Test Strips. The BioTel Care is also compatible with the Control Solution Telcare®...
  • Page 39 E.4 Setting Up Your BioTel Care BGM Your BioTel Care BGM time is automatically updated with the local date and time when a cellular connection is estab- lished. If you would like to view your meter’s preset settings, navi- gate to the Settings screen.
  • Page 40 This screen provides a listing of current software and related information about your meter. This is helpful if you need technical support. F. Maintenance of Your BioTel Care and Lancing Device Charging Your BioTel Care BGM Your BioTel Care BGM uses a rechargeable battery.
  • Page 41 To Charge Your Device 1. Plug the power cord into an electrical outlet. 2. Plug the other end of the cord into the BGM’s charging port. Charging Troubleshooting If your device does not turn on when you press the power button on, your battery may not be fully charged.
  • Page 42 Cleaning and Disinfecting What is the difference between cleaning and disinfecting? Cleaning and disinfecting are not the same thing. Cleaning simply removes blood and dirt. Disinfecting kills germs and provides an extra level of safety. In the following procedure, the first disinfectant towel is used for cleaning, and the second towel provides for disinfection.
  • Page 43 7. Wait at least one minute and make sure device is completely air dried before next blood test. The BioTel Care BGM has been validated for 1,825 cleaning and disinfection cycles. Please obtain a new meter after cleaning and disinfecting the meter 1,825 times or once the lifetime of the meter (5 years) has been reached, whichever comes first.

  • Page 44: Warranty Information

    • Stop using the meter and contact customer service immediately if you notice any of the following signs of deterioration: • The meter does not turn on. • The meter is damaged or has stopped working. • The meter’s screen has been cracked or has become clouded.

  • Page 45: Error Codes

    G. Storing Your BioTel Care BGM and Test Strips • Your meter is a delicate electronic device that should be handled with care. Severe shock, such as dropping the meter, could damage it. • The meter and test strips only work in the temperature range of 50˚F (10˚C) to 104˚F (40˚C).
  • Page 46 Action to take: Restart meter and contact Telcare support if the problem continues. Turn your meter off before calling Telcare at (888) 666-4530 (US) or (1) (978) 610-4688 (International). 2. Error Message: “Used Strip Detected! Please insert a new strip.” What it means: Your test strip may be used or damaged.

  • Page 47: Other Messages

    If you still receive the same message, call your caregiver immediately. 4. Message: Software updates are available in the App Store for your BGM What it means: A critical or non-critical software update is available on the App Store. If the update is critical, you won’t be able to use other meter functions until the...
  • Page 48 5. Error: Meter freezes or restarts What it means: Your meter may require rebooting or software updates. Action to take: Check your meter’s battery charge level. Charge your meter if low or very low battery. Turn off your device, wait 10 seconds, and turn your device back on.

  • Page 49: Specifications

    Terms of Warranty Telcare warrants the BioTel Care BGM to be free of defects in workmanship and materials under normal use for a period of one (1) year from the date of purchase. The liability of Telcare, LLC is limited to repair or replacement. In no event shall Telcare be liable for any collateral or consequential damages or loss.
  • Page 50 Memory: 10,000 blood test results with date and time stamp Result Averaging: 7, 14, 30, and 90 days averaging displayed on BioTel Care BGM Dimensions: 121L x 65W x 13H (mm) Weight: 145 grams Battery: Rechargeable, Lithium Ion 1800mA hour battery, replaceable.
  • Page 51 Telcare, LLC encourages you to visit these websites for updated information. The BioTel Care BGM is not a cell phone but is considered a similar wireless device. You can access the FDA website at http://www.fda.gov/Radiation-EmittingProducts/...
  • Page 52 This device functions on CDMA 2000 BC0 (850mHz) and BC1 (1900mHz) and uses CDMA 2000 1x and EVDO. The following are operating characteristics of the BioTel Care BGM • Effective RF Radiated Power Output and Operating Range: Less than 24 dBm •...
  • Page 53 IEC 61326-1: 2013, IEC 61326-2-6:2013 Test Condition Compliance Radiated Emission Complies (30MHz to 1000MHz) Conducted Emission on AC 150kHz to 30MHz Complies Harmonic Class A Complies Flicker Complies IEC 61326-1: 2013, IEC 61326-2-6:2013 Immunity Tests Compliance Electrostatic Discharge (IEC 61000-4-2) ±4kV ±8kV Complies Radiated Immunity (IEC 61000-4-3) 80MHz to 1000MHz 3V/m (rms) 1400MHz to 2000MHz 3V/m (rms)2000MHz to...
  • Page 54 turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
  • Page 55 “Company” or “Telcare” or “we” or “us”), the operator of www. mytelcare.com, www.telcaresupplies.com and related websites (collectively, the “Sites”). This Agreement governs your use of the Sites, both as a visitor and a registered member as described below, and purchase, use of the BioTel Care™ blood glucose...
  • Page 56 meter (the “Meter”) and/or access to the Telcare service (collectively, the “Service”). By accessing or using the Sites, the Meter and the Service, you agree to be bound by the terms of this Agreement. IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, WE HEREBY REQUEST THAT YOU DO NOT OPEN THE METER AND RETURN THE METER TO TELCARE PURSUANT TO THE INSTRUCTIONS TO BE PROVIDED TO YOU...
  • Page 57 YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH PROVIDER WITH ANY QUESTIONS YOU MAY HAVE REGARDING YOUR HEALTH. NEVER DISREGARD PROFESSIONAL MEDICAL ADVICE OR DELAY IN SEEKING IT BECAUSE OF SOMETHING YOU HAVE READ ON THE SITES OR RECEIVED AS PART OF THE SERVICE. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR OR 911 IMMEDIATELY.
  • Page 58 their membership, is true and accurate and not misleading. Use of Sites by Members and Non-Members. You may not use any robot, spider, scraper, or other automated means to access the Sites, the Service or content or services provided on the Sites for any purposes. You may not post content on the Sites or as part of the Service that contains any viruses, Trojan horses, worms, time bombs, spiders, or other computer programming routines that are intended to...
  • Page 59 (a) set up and establish your account and activate your Meter, including recording your initial A1c results from your physician or health care provider; (b) operate and improve our Services; (c) respond to your comments and questions and provide customer service; (d) provide and deliver products and services you request;...
  • Page 60 agree that anyone you’ve shared such data with may access and use that data which such use shall not be subject to Telcare’s Privacy Policy. You agree that SMS and email messages sent to authorized users are for informational purposes only. Furthermore, you hereby acknowledge and agree that Telcare shall be permitted to view any and all of your data (“End User Data”) for the sole purpose of complying with FDA regulations...
  • Page 61 Posting and Use of Content in the Member Area. The Member Area includes community areas, such as forums and member areas, where members may post messages, images, and other content. If you are a member, you (or the author) owns the copyright in the messages, images, and other content you post in the Member Area, but by posting such content to the Member Area you grant Telcare and our affiliates the right and irrevocable, unlimited, worldwide, and royalty free license to...
  • Page 62 Links to Other Websites. The Sites may contain links to other websites that are not under the control of Telcare. The inclusion of any link does not imply endorsement by Telcare of such website and Telcare is not responsible for the content of such linked websites. Membership Termination.
  • Page 63 Please check the webpage www.telcare.com for changes from time to time to make sure you are aware of our latest Terms of Service. If we make any changes to the Terms of Service, we will change the “Last Updated” date. Membership to the Sites is currently free.
  • Page 64 time you will be charged only for the goods we have actually shipped along with any appropriate taxes or shipping charges). However, we may pre-authorize your order amount with your credit or debit card issuer at the time you place the order, which may have an effect on your available credit line.
  • Page 65 reason. If we reject your order, we will generally attempt to notify you using the e-mail address you gave us when you placed the order. Telcare may, at its own discretion, limit or cancel quantities purchased per person, per household or per order. Telcare also reserves the right to reject any order you place with us.
  • Page 66 THE ADVICE, RECOMMENDATIONS, INFORMATION, AND CONCLUSIONS POSTED OR EMAILED BY OTHER MEMBERS OF THE SITES ARE NOT IN ANY WAY VETTED, APPROVED OR ENDORSED BY TELCARE, AND YOU USE SUCH INFORMATION AT YOUR OWN RISK. NOT ALL PRODUCTS SOLD ON THIS SITES HAVE WARRANTIES. WARRANTIES ARE LIMITED TO INDIVIDUAL PRODUCTS WHEN APPLICABLE.
  • Page 67 outside your resident jurisdiction as detailed in our Privacy Policy. If you do not consent to such transfer, you may not use the Sites or the Service. Member Notices. If you register as a member, you agree that Telcare may send notices to you by email at the email address you provide when registering to become a member (or which you later update using the functionality of the Sites or the Service).
  • Page 68 or drug combination is safe, effective or appropriate for any given patient. For any returns, questions or comments, or to report violations of this Agreement contact us at: Telcare, LLC 150 Baker Avenue Extension, Suite 300 Concord, MA 01742 (888) 666-4530 support@telcare.com IF YOU DO NOT AGREE TO THE TERMS AND CONDITIONS OF THIS AGREEMENT, PLEASE DO NOT OPEN OR USE THE METER...
  • Page 69 K. Privacy Policy Telcare, LLC Privacy Policy (Last Updated May 17, 2018) General THESE TERMS OF USE SHALL BE DEEMED TO BE ACCEPTED UPON YOUR OPENING OF AND USE OF THE METER. At Telcare, LLC , we are committed to respecting your privacy.
  • Page 70 • When you visit our websites, some information is automatically collected. For example, when you visit our web sites your computer’s operating system, Internet Protocol (IP) address, access times, browser type and language, and the website you visited before our site are logged automatically. We also collect information about your usage and activity on our Sites.
  • Page 71 • communicate with you via email, mobile alerts, SMS text messages and other messaging services about commercial, non-commercial, sponsored and non-sponsored clinical information, messaging regarding your blood glucose readings and testing frequencies, FDA and product safety alerts and our selected partners (if you do not wish to receive these kinds of emails, you may choose to opt out by updating your profile;...
  • Page 72 We may share personal information under the following circumstances: • with third party vendors, consultants and other service providers as needed to perform their job functions; • to (i) comply with laws or to respond to lawful requests and legal process, (ii) to protect the rights and property of our agents, customers, and others including to enforce our agreements, policies and terms of use or (iii) in an emergency to protect the personal safety of Telcare, its customers, or any...
  • Page 73 How to update your profile: Please visit the home page of our website at www.telcare.com, click on “Mytelcare Login”, and then sign in using your email address and password. To opt in or out of email communications, go to the bottom of the form and make the selection of your choices.
  • Page 74 the user’s real age if the information provided to us is not correct. All personal information of minors younger than 13 years old may only be provided, used and shared by us, with the consent and guidance of, their parents or guardians. The parent or guardian is responsible for supervising the child’s use of, and access to, our Services.

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