BioTel Care BGM User manual
1
A Intended Use (pg. 2)
B Important Safety Instructions (pg. 2)
C Getting Started (pg. 3)
D Your BioTel Care BGM™ (pg. 5)
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 Troubleshooting (pg. 45)
I About Your System (pg. 50)
J Terms of Service/Use (pg. 55)
K Privacy Policy (pg. 69)
Contents
Blood Glucose
Monitoring System
User Manual
This product contains a rechargeable internal battery. To conserve
battery power this product will turn o the screen after one
minute of non-use. To turn on the product either insert a test strip
or press any side button.
TM
ART-161 Rev. 6
Not Intended for Sale Within the EU
2
A. Intended Use
The BioTel CareTM Blood Glucose Monitoring system is intended
for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips, forearm, or
palm. It is intended for lay use by persons with diabetes to aid
in diabetes management. It is indicated for use at home (over
the counter [OTC]) and should be used only by a single patient
and should not be shared. Test results are plasma-calibrated for
easy comparison to clinical laboratory methods. Testing is done
outside the body (in vitro diagnostic use). The BioTel CareTM
Blood Glucose Monitoring System consists of the BioTel Care
BGMTM Blood Glucose Meter, BioTel CareTM Blood Glucose Test
Strips, and BioTel CareTM Glucose Control Solutions. The BioTel
CareTM Blood Glucose Monitoring system is not indicated for the
diagnosis or screening of diabetes or for neonatal use. Palm and
forearm testing should be done only during steady-state times
when glucose is not changing rapidly. The BioTel CareTM Blood
Glucose Meter uses cellular data transmission to send test results
to Telcare’s remote database, Telserve, and to receive messages
from Telserve. The BioTel CareTM Blood Glucose Monitoring
System is not intended to provide automated treatment guidance
or decisions, nor is it to be used as a substitute for professional
healthcare judgment.
B. Important Safety Instructions
The
BioTel CareTM
Blood Glucose Monitoring System and lancing
device are for single patient use.
Do not share them with anyone, including family members! Do
not use on multiple patients! Do not transfer ownership.
Because all parts of the kit may come in contact with your blood,
all parts are considered biohazardous. Kit parts can potentially
transmit infectious diseases, even after cleaning and disinfection.
Dispose of in accordance with local regulations.
3
Users should wash hands thoroughly with soap and water and
dry thoroughly after handling the meter, test strips, and any
lancing device.
For Cleaning and Disinfecting procedures to prevent the spread
of diseases such as Hepatitis B, see Cleaning and Disinfecting
Your Meter (pg. 42).
For Technical Support, contact Telcare, LLC at (888)
666-4530 (US) or (1) (978) 610-4688 (International).
Hours of Operation: Monday -
Friday, 9AM - 9PM EST
References
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.
gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
“Protection of Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline–Third Edition. Clinical and Laboratory Standards Institute (CLSI), document
M29-A3, (ISBN 1-56238-567-4).
All images for
reference only
Thank you for choosing the
BioTel
CareTM
Blood Glucose Monitoring
System. The
BioTel CareTM
system
is comprised of the
BioTel CareTM
meter and the online website. The
meter provides accurate readings
sent immediately to your online
account to store, track, and chart.
Personalized messages are also sent
to the meter. This manual will provide
you with all you need to know to use
your new meter. So let’s get started!
C. Getting Started
4
Unboxing the BioTel Care BGMTM for the first time
Before we begin, take a moment to go over the contents of your
BioTel Care BGMTM kit. Your kit should include:
• BioTel Care BGMTM
(battery included)
• AC Charger
• Quick Start Guide
• User Manual
• Test Strip Insert
• Control Solution Levels 1 & 2
(2.5 mL)
• Lancing Device
• BioTel CareTM Lancets (10
count)
• BioTel CareTM Test Strips (10
count)
Using your new meter:
Make sure you charge your glucose meter for at least 6 hours
before first use. To charge your glucose meter, use the AC
Charger included in your kit.
Important: Please remove the protective film over the screen.
Please wait for the meter to finish the boot process to start a
test when it powers on.
You should use the BioTel Care BGMTM for:
• Testing Blood Glucose
• Testing only with fresh capillary whole blood samples
You should NOT use the BioTel Care BGMTM for:
• The diagnosis of Diabetes
• Testing blood glucose on newborn infants
• Testing of arterial blood
• Testing of venous blood
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D. Your BioTel Care BGMTM
Left side
Back button Info button
Right side
This is a
Touch Screen
Power (PWR) Button
•
Short-press of power button turns on/o the screen.
• Long-press of power button when screen is on pops out a
window with the following options: Power O, Restart, and
Airplane Mode / Silent, Vibrate, and Sound.
UP/Down
• Buttons to scroll through menus
Enter Button
Display Touch Screen
Insert Test Strip (white side up)
Battery Access Notch
• Use the notch to remove the battery cover and replace the
battery
Home button
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Back button
• Press of back button returns to the previous screen except in
Test Mode.
Home button
• Press of home button returns to the Home screen except in
Test Mode.
Info button
•
Press of info button displays a dialog box with helpful
information for the current screen.
Contact End (put into device)
Blood Sample End
BioTel CareTM Test Strips
Preparation and Safety
Important Notes on Test Strips:
• Because of the auto coding feature of this meter, the strip
insertion will be snug. This is to be expected and users find it
easy after a few attempts.
• Check the expiration date printed on the test strip bottle and its
package. DO NOT use expired test strips.
• Use each test strip immediately after removing it from the
bottle.
• Do not use wet or damaged test strips.
• Wash your hands and testing site thoroughly with warm water
and soap. Dry your hands well.
• Test in a place where the temperature range is between 50˚F
(10˚C) and 104˚F (40˚C). (See “Troubleshooting” for more
information - pg. 45.)
Before you begin, make sure to:
• Set up your BioTel Care BGMTM Blood Glucose Meter properly.
• Run a control test before first use. (See Step-by-Step Guide to
Control Testing - pg. 18.)
• Keep away from direct sunlight and heat. Store the test strip
bottle in a dry cool place.
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• Record the “date opened” on the bottle label. Discard the
bottle and any remaining test strips 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 BGMTM is compatible with Telcare
®
Test Strips and
Telcare
®
Glucose Control Solutions.
IMPORTANT WARNINGS ABOUT INACCURATE RESULTS
Inaccurate results may occur in severely hypotensive individuals
or patients in shock. Inaccurate low results may occur for
individuals experiencing a hyperglycemic hyperosmolar state,
with or without ketosis. Critically ill patients should not be tested
with blood glucose meters.
FOLLOW THESE IMPORTANT SAFETY GUIDELINES
• Please follow cleaning and disinfecting instructions for the
meter and lancing device to prevent the risk of blood-borne
pathogen transmission!
• Follow any cleaning/disinfection instructions that may come
with the lancing device you use.
• The meter and lancing device are intended for a single user
and should not be shared.
• Make sure you wash with soap and water and dry hands
thoroughly before and after handling the meter, lancing
device, or test strips.
You will need:
• Your BioTel Care BGMTM • A new BioTel CareTM Test Strip
• A lancing device with a clean, unused lancet (or safety lancets)
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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)
to access the meter’s
options:
• Test Mode • Logs
• Summary • Messages
• Support • Settings
• Apps • Reminders
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Icon Definitions
Symbol
Carrier Name The name of the cellular carrier to which
the meter is currently connected.
Descriptions
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.
Indicates that the battery is actively charging.
These items are displayed in an animated
fashion from top to bottom in order to depict
active charging of the meter battery.
Indicates the battery is getting low and needs
to be charged.
Indicates the strength of the wireless signal
between base station and the meter in a
manner familiar to most users. Additional
bars of signal depict increased signal
strength. The user manual instructs users
that two bars or less of signal may result in
unreliable transmission and reception of data.
The 3G or 1X icon may be displayed with the
wireless icon based on the network in use.
The letter “R” or triangle icon indicates that
the meter is roaming on the network of
a cellular carrier dierent from the home
carrier. The user manual does not need to
describe roaming features since Telcare has
negotiated national roaming agreements for
the product.
The letter “X” is used to indicate no wireless
signal connectivity.
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Symbol Descriptions
The airplane icon is used to indicate that
wireless function is disabled by user
selection of “airplane” mode from the setup
menu
The status bar shows this icon when
charging is shut o because battery
temperature is too high/low.
The screen displays this icon when charging
is shut o because battery temperature is
too high/low.
D.1 Testing Your Blood Glucose
1. Power on the BioTel Care
BGMTM with the PWR
(Power) button on the right
side of the BGM. Long
press if it is in OFF mode,
short press if it is in SLEEP
mode. The device will
automatically display the
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.
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a
b
c
d
f
g
i
h
e
AUTOLET PLUS COMPONENTS
a. Depth adjuster
b. Depth setting indicator window
c. Activation button
d. Cocking/lancet release slider
e. Lancet holder
f. Lancing device cap
g. Lancet cap
h. Lancet
i. Optional alternate site testing cap (Not
included/Can be special ordered)
5.1 5.2
5.3 5.4
5.5 5.6
5.8
5.9
5.7
3. Take out a BioTel CareTM
Test Strip from the bottle,
and close the bottle
immediately. (Some meters
require the user to enter a
code from the vial. BioTel
CareTM and Telcare® strips
do not require a code.)
4. Firmly insert the test strip
into your BioTel Care BGMTM
until it is fully seated. The
strip port light will turn on.
5. Prepare Your Lancing
Device (Refer to
Components Illustration)
5.1 Remove the lancing
device cap (f) by
snapping it o at an
angle.
5.2 Insert a new lancet (h)
into the lancet holder
(e). This action will
cock the device.
5.3 Hold the lancing
device firmly in one
hand, use your other
hand to twist o the
lancet cap (g).
5.4 Place the lancing device cap (f) back on the device with
the depth setting indicator window (b) aligned with the
activation button (c).
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5.5 Set the depth adjuster (a). The lancing device oers 9
depth settings. Level 1 is the shallowest depth; Level 9 is
the deepest.
5.6 To prime the device pull back on the grey slider until
it clicks (d), (You may have already cocked/primed the
device in Step 5.2). You are now ready to obtain a blood
sample.
5.7 To lance your finger hold the lancing device firmly
against the side of your fingertip. Press the activation
button (c). Apply gentle pressure near the puncture site if
needed, until a blood drop appears.
5.8 To release the used lancet, first remove the lancing
device cap (f), push the lancet release slider forward/
downward (d). If the lancet does not detach, push the
slider foward and carefully hold the sides of the exposed
lancet. Firmly pull the lancet away from the
device.
5.9 The lancet should be removed and disposed in
accordance with local waste regulations.
Important Information for Lancing Device
•Use the BioTel CareTM or Telcare® Lancing Device included
in your BioTel CareTM Blood Glucose Monitoring System to
obtain a blood sample. The minimum blood sample volume is
0.8 microliters.
•Purchase an additional BioTel CareTM Lancing Device by
calling Telcare, LLC at (888) 666-4530 (US) or
(1) (978) 610-4688 (International). (9AM - 9PM EST, M-F).
•If using another type of lancing device, please refer to its user
manual.
Important Safety Procedures Regarding Lancets
• To avoid contamination, use a new lancet every time you test.
It is important to discard the used lancet carefully after each
use to avoid unintended lancet stick injuries. Used lancets may
be considered biohazardous waste in your area. Be sure to
follow your local regulations for proper disposal.
13
How to choose the cap
• For fingertip testing, use the colored cap included on the
lancing device.
• For alternate site testing on your palm, use the clear cap.
Tips for fingertip testing
• Gently massage your hand and finger toward the puncture site
to form a drop of blood. Do not “milk” or squeeze around the
puncture site.
•
Lance the side of your fingertip to avoid soreness. To avoid
calluses, choose a dierent lancing site each time.
Position the end of the adjustable
comfort tip against the side of the
fingertip. Press the trigger button,
and then lift the lancing device
away from the finger after the
puncture is complete.
6. Testing Using an Alternate
Test Site
This package does NOT
include an alternate site
cap. If you require one,
please contact Telcare,
LLC.
Important Information on
Alternate Site Testing
You BioTel Care BGMTM is
capable of testing your
blood glucose from your palm, usually referred to as an
alternate site test, or AST.
• If alcohol wipes are used to clean your finger or palm, make
sure your skin is dry before the blood sample is obtained.
• Lancing devices should NEVER be used by more than one
person.
• If the seal is broken, discard the lancet.
14
Alternate site testing can be less painful than fingertip
testing. However, because of the physiological dierences
between your fingertip and palm, AST results may be
significantly dierent.
Alternate site testing should not be used to calibrate a
continuous glucose monitor nor should it be used in insulin
dose calculations.
Alternate site testing should only be used during steady
state blood glucose conditions when glucose is not changing
rapidly.
You should consult with your doctor before using alternate
site testing.
Testing on Your Palm
Prepare the lancing device with a new lancet and clear cap. Cock
the lancing device so that it is ready to use. Select a site on your
palm that does not have veins, moles, excessive hair, or bone.
Vigorously rub the side of your palm with your other hand for at
least 10 seconds. You should feel it get quite warm.
Press the opening of the clear cap against a fleshy area of the
palm. Press the lancing device up and down in a slow pumping
motion for several seconds to help the flow of blood.
Keep steady pressure on the area and press the release button.
Do not be afraid to apply pressure to the area with the lancing
device to assist the flow of blood. Continue to press the cap
against the area for a few seconds to allow blood to come to
the surface. You can see the blood drop through the clear cap.
Lift the lancing device straight up. Do not smear the blood when
removing the lancing device. If the blood drop is too small, the
meter will show Error: Not Enough Blood. Insert a new strip and
obtain a new blood drop.
If the results from alternate site testing dier from how you
feel, use fingertip testing instead.
15
7. Applying Blood to the Test Strip
Gently touch the test strip to the drop of blood. The test
strip will absorb the blood. Keep the test strip in the blood
drop until you see the blood sample end of the test strip fill.
8. Tagging Your Data
The screen will start to count
down. After 6 seconds, your
glucose level will appear on the
display screen. You can select
a Reading Tag (e.g., “Before
Breakfast”) from the list displayed
during or after countdown. Swipe
down OR use the DOWN key to
select the correct tag. Press on
the CONTINUE button OR use the
ENTER key to confirm.
Your test result will be
automatically stored into the
meter history. If a Reading Tag is
not selected in the allotted time,
it will automatically be tagged as
“No tag”.
9. Sending Your Results
After pressing the CONTINUE
button, your BioTel Care BGMTM
will send the results to Telcare’s
secure server.
10. Remove the used test strip and
discard it properly.
CLINICAL RESPONSE SCREEN:
During data transmission, you will see a dial that compares
your reading to your set target. To change your set target,
call your doctor or Customer Support at (888) 666-4530
(US) or (1) (978) 610-4688 (International). You may also
see helpful guidance from your caregiver regarding this
reading to manage your diabetes.
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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. If you still receive the same
message, call your caregiver immediately.
OPTIONAL: After successful data transmissions to the server,
you may receive a multiple choice question to answer. This
may be a question from your caregiver or relate to reordering
supplies. Swipe up/down OR use the UP/DOWN buttons to
select the appropriate answer. Press on the option OR use the
ENTER button to transmit.
If Your Data Transmission is Not Successful
If the device cannot communicate with the server, the following
message will appear:
No network connection. Reading will be sent when a
connection returns.
Your test results will be stored in your device. You can send the
reading on your own by going into Logs from the main menu.
For the transmission to be successful, network connection is
required.
The meter will attempt to forward unsent readings automatically.
Readings that have not been transmitted to the server will be
marked with a yellow triangular hazard icon in the Logs list.
IF DATA TRANSFER FAILS, YOU MAY USE THIS PRODUCT
LIKE ANY OTHER GLUCOSE METER. FOLLOW YOUR
HEALTH CARE PROFESSIONAL’S INSTRUCTIONS ON
TREATMENT.
Understanding Your Blood Glucose Test Results
Blood glucose value will vary depending on food intake,
medication, health, stress, and exercise. The ideal ranges for
people without diabetes are as follows1:
• 70 to 100 mg/dL before meals, and
• 70 to 140 mg/dL after meals
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What to do if you get high or low readings AND you feel ill.
If the BioTel Care BGMTM displays results that are “High” or
“Low,” or you get a result that is more than 250 mg/dL or below
50 mg/dL AND you feel ill:
• Treat your diabetes according to the instructions from your
doctor.
If the BioTel Care BGMTM displays results that are “High” or
“Low,” or you get a result that is more than 250 mg/dL or below
50 mg/dL AND you DO NOT feel ill:
• Test your BioTel Care BGMTM with a control solution: refer
to”Step-by- Step Guide to Control Testing.” (pg. 18)
• Wash your hands, dry thoroughly and test again using your
fingertip.
If you still get a high or low reading, contact your doctor
immediately.
References
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 BGMTM
and Test Strips are working properly. You should perform control
solution testing when:
• Using the meter for the first time
• Using a new bottle of BioTel CareTM Test Strips
• You left the test strip bottle cap open
• You dropped the meter
• You suspect the meter and test strip are not working
properly
• The test results do not reflect how you feel
• Practice the testing
• The test strips are exposed to environmental conditions
outside the temperature requirements printed on the label.
18
1. Power on the BioTel
Care BGMTM with the
PWR button on the
right side of the BGM.
The device will
automatically display
the Home Screen with
the last reading as
shown.
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
solution, press on the L1
CONTROL button OR use
the UP/DOWN buttons
to highlight L1 CONTROL
button.
Step-by-Step Guide to Control Solution Testing
Purchase additional control solution by calling Telcare, LLC at
(888) 666-4530 (US) or
(1) (978) 610-4688 (International) (9AM-9PM EST, M-F)
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,
press on the L2 CONTROL button
OR use the UP/DOWN buttons to
highlight L2 CONTROL button.
3. Take out a BioTel CareTM Test Strip
from the test strip bottle. Close the
bottle immediately.
4. IMPORTANT:
• Firmly insert the test strip into your
BioTel Care BGMTM until it is fully
seated. The strip port light will turn
on.
• The term “BioTel Care” or “Telcare”
should be facing up.
• The sample tip should be facing up.
• Continue to push the strip in until
“Apply Level 1 (2) Control Solution”
appears.
• Do not touch the sample tip
5. Use Level 1 solution for L1 mode. Use
Level 2 solution for L2 mode. Squeeze
a drop of control solution onto a
clean, dry, non-absorbent surface.
Immediately replace the bottle cap
on the control solution bottle. Do not
apply control solution to the test strip
directly from the bottle.
6. Gently touch the tip of the test strip
to the drop of control solution. You
should see the sample end of the test
strip fill.
*Control Solution Range (Images are for reference only. Actual
numbers may vary.)
20
7. The screen will start to count down. After 6 seconds, the
control test result will appear on the meter’s display screen.
8. Compare the reading on the screen to the “L1 Control
Solution” or “L2 Control Solution” range printed on the test
strip bottle or package. If the reading on the meter falls
within the appropriate range, select the YES tag. If not, select
the NO tag. If the reading falls outside the level printed on
the bottle or package that you used, please see “Control
Solution Troubleshooting” (pg. 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 CareTM or Telcare® Glucose Control Solution
with the BioTel CareTM or Telcare®Test Strips. Other brands of
control solution or test strips may produce inaccurate results.
2. Always check the expiration date. DO NOT use expired
control solution.
3. DO NOT FREEZE. Store the control solution at room
temperature.
4. Never touch the tip of the control solution bottle to the test
strip. It will damage all remaining solution in the bottle.
5. Record the “date opened” on the bottle label.
6. Do not use the control solution if more than 3 months since
first opened.
Control Solution Troubleshooting
If your control solution testing is out of range (too high or too
low), it may be caused by the following:
• Wrong brand of control solution
• Control solution not at room temperature
• Expired or contaminated control solution
• Damaged test strip
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