TELCARE TCTM0001 User Manual

TELCARE™ Blood Glucose Monitoring System
TELCARE™ Blood Glucose
Monitoring System
User Manual
TELCARE™ Blood Glucose Monitoring System
e TELCARE™ Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the ngertips, 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 plasma­calibrated for easy comparison to clinical laboratory methods. Testing is done outside the body (in vitro diagnostic use). e TELCARE™ Blood Glucose Monitoring System consists of the Telcare BGM™ Blood Glucose Meter, TELCARE™ Blood Glucose Test Strips, and TELCARE™ Glucose Control Solutions. e TELCARE™ 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. e Telcare BGM™ Blood Glucose Meter uses cellular data transmission to send test results to TELCARE™’s remote database, Telserve, and to receive messages from Telserve. e TELCARE™ 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.
Intended Use
(i)
TELCARE™ Blood Glucose Monitoring System
e TELCARE™ Blood Glucose Monitoring System and lancing device is for single patient use. Do not share it with anyone, including family members! Do not use on multiple patients!
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 aer cleaning and disinfection.
Users should wash hands thoroughly with soap and water and dry thoroughly aer 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. 31).
For Technical Support contact TELCARE™ at (888) 666-4530. Hours of Operation: Monday - Friday, 9AM - 5PM EST
References
“FDA Public Health Notication: 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–ird Edition. Clinical and Laboratory Standards Institute (CLSI), document M29-A3, (ISBN 1-56238-567-4).
Important Safety Instructions
(ii)
TELCARE™ Blood Glucose Monitoring System
(iii)
Your Telcare Blood Glucose Meter
The Telcare BGM
Device 2 Telcare Test Strips 3 The Display Screen 4 Setting Up Your Telcare BGM 5 Settings Options 6
Control Solution Modes
Step by Step Guide to Control Testing 8
Testing Your Blood Sugar
Preparation and Safety 14 Prepare Your Lancing Device 17 Understanding Your Blood Glucose Test Results 28
Viewing Your Meter’s Memory 29
Maintenance of Your Telcare BGM and Lancing Device
Cleaning and Disinfecting Your Meter 31 Cleaning and Disinfecting Your Lancing Device 33 Charging Your Telcare Blood Glucose Meter 35
Storing Your Meter and Test Strips 36
Troubleshooting 37
Terms of Warranty 40
Specifications 41
About Telcare 42
Contact Telcare 43
Table of Contents
TELCARE™ Blood Glucose Monitoring System
1
Unboxing the Telcare BGM
for the first time
Before we begin, take a moment to go over the contents of your Telcare BGM kit. Your kit should include:
n Telcare BGM
Blood Glucose Meter (battery included)
n AC Charger
n Instruction Manual n Telcare Test Strips (10) n Telcare Glucose Control Solution n Lancing Device n Lancets
Make sure you charge your glucose meter for at least 12 hours before first use. To charge your glucose meter, use the AC Charger included in your kit.
You should use the Telcare BGM for:
n Testing blood glucose.
n Testing only with fresh capillary whole blood samples.
You should NOT use the Telcare BGM for:
n The diagnosis of diabetes.
n Testing blood glucose on newborns.
n Testing of arterial blood.
n Testing of venous blood.
Your Telcare Blood Glucose Meter
TELCARE™ Blood Glucose Monitoring System
2
The Telcare BGM™ Device
2
6
5
7
1
1 Power Button
2 UP / DOWN Keys
3 Enter Button
4 Display Screen
5 Insert Test Strip
(white side up)
6 Charging Port
(do not attempt to
insert strip here)
7 Wireless Signal
Indicator
2
3
4
TELCARE™ Blood Glucose Monitoring System
3
Telcare Test Strips
Blood Sample End
Contact End
(put into device)
IMPORTANT NOTES ON TEST STRIPS:
n Because of the autocoding feature of this meter, the strip insertion will be
snug. This is to be expected and users find it easy after a few attempts.
n Check the expiration date printed on the test strip bottle and its package.
Do Not use expired test strips.
n Use each test strip immediately after removing it from the bottle.
n Do not use wet or damaged test strips.
n Keep away from direct sunlight and heat. Store the test strip bottle in a dry,
cool place.
n Record the “date opened” on the bottle label. Discard the bottle and any
remaining test strips 3 months after the date of opening.
n Do not operate the meter outside the temperature range of 50˚F to 104˚F.
TELCARE™ Blood Glucose Monitoring System
The Display Screen
4
From the Display screen, you can see the following things:
n Wireless Signal Strength n Current Time n Battery Level n Last Test Reading n Time of Last Reading
In this Display screen, use the UP/DOWN buttons (located on the left of your meter) to access the meter’s options:
n Test Mode n L1 Control Solution Mode (Low) n L2 Control Solution Mode (High) n Settings Menu
The Display Screen
1 Wireless Signal Strength
2 Current Time
3 Battery Level
4 Last Test Reading
5 Time of Last Reading
3 2
1
4
5
TELCARE™ Blood Glucose Monitoring System
Setting Up Your Telcare BGM
5
Your Telcare BGM is preset with your information, including your time zone. During each cellular connection, Telserve will validate the time displayed is accurate. Telserve will automatically update your BGM clock, if appropriate. Also, if your physical location changes, Telserve will recognize your time zone change and update your meter.
If you would like to view your meter’s preset settings, navigate to the Settings screen.
Getting to the Settings Screen
1 Power (PWR) your Telcare BGM device on.
2 Use the UP/DOWN buttons to reach the “Settings” screen.
IMPORTANT: Slight delays occur when meter powers on. If delay is greater than 20 seconds, do not use meter. Contact technical support at (888) 666-4530.
TELCARE™ Blood Glucose Monitoring System
6
Settings Options
Alarms
Create up to 3 alarms to help remind yourself when to test next.
Date and Time
This page allows you to view the Date and Time settings of your device.
Volume
This page allows you to select the volume of your meter. Use the UP/DOWN keys to select the appropriate volume. There are six possible volumes you may select from.
Mobile Network
This is an advanced feature. This page allows you to view the details of the mobile network your device uses for communication to the MyTelcare.com Web Portal. We recommend you do not change the factory settings.
Auto-Sync
Disabling Auto-sync will prevent the meter from communicating with the MyTelcare.com Web Portal (Not Recommended). Readings will still be stored in the meter.
TELCARE™ Blood Glucose Monitoring System
7
Memory Recall
Your last 300 glucose and control test readings are stored within the meter. Please see “Viewing Your Meter’s Memory” (page 29) for further details. To send a reading to MyTelcare.com, highlight it and push the Enter button. If a reading has already been stored on MyTelcare.com and you attempt to send it, an error will appear on 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. Your meter’s clock will continue to work properly while in this mode.
If a time zone change occurs, your meter will not automatically update to the new time until Airplane Mode has been disabled. The meter will reset the time from the new network.
About
This screen provides a listing of current software and related information about your meter. This is helpful if you need technical support.
TELCARE™ Blood Glucose Monitoring System
Control Solution Modes
8
Control solution testing is to make sure your Telcare BGM™ and Test Strips are working properly. You should perform control solution testing when:
n Using the meter for the first time. n Using a new bottle of Telcare Test Strips. n You left the test strip bottle cap open. n You dropped the meter. n You suspect the meter and test strips are not working properly. n The test results do not reflect how you feel. n Practicing the testing. n The test strips are exposed to extreme environmental conditions.
Purchase additional control solution by calling Telcare at (888) 666-4530 (9AM - 5PM EST, M-F).
Step by Step Guide to Control Testing
Power on the Telcare BGM device with the
PWR button on the right side of the BGM.
The device will automatically start in
“Normal Test Mode,” ready to check blood
glucose. You will see the “Insert test strip”
screen as shown.
1 2
TELCARE™ Blood Glucose Monitoring System
9
3
Use the UP / DOWN keys on the left side of
the BGM to access the main menu. Switch
modes from “Normal Test Mode” to
L1 Control Solution Mode.
To test Level 1 (L1) control solution, use the
UP/DOWN buttons to highlight L1 mode.
Press the middle (ENTER) button to select
L1 mode.
Upon successful completion of Level 1
(L1), test Level 2 (L2) control solution.
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.
To test Level 2 (L2) control solution, use the
UP/DOWN buttons to highlight L2 mode.
Press the middle (ENTER) button to select
L2 mode.
TELCARE™ Blood Glucose Monitoring System
10
You can select any Mode you want by
pushing the ENTER button.
Take out a Telcare Test Strip from the test
strip bottle. Close the bottle immediately.
IMPORTANT:
- Insert the strip into the strip port at a
slight downward angle for it to properly
seat in the meter.
- The word “Telcare” should be facing up.
- The sample tip should be facing up.
- Continue to push the strip in until Apply
Blood appears.
Sample Tip
4 5
6
TELCARE™ Blood Glucose Monitoring System
11
Squeeze a drop of control solution onto a
clean, dry, non-absorbing surface. Use Level
1 solution for L1 mode. Use Level 2 solution
for L2 mode. Do not apply control solution
to the test strip directly from the bottle.
Immediately replace the bottle cap on the
control solution bottle.
Gently touch the tip of the test strip to the
drop of control solution. You should see the
blood sample end of the test strip fill.
The screen will start to count down. After
6 seconds, the control test result will appear
on the meter’s display screen.
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8
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