Related Manuals for Entra Health System BLE Smart
Summary of Contents for Entra Health System BLE Smart
- Page 1 BLE Smart ™ Blood Glucose Monitoring System USER MANUAL P/N: MU-BLE-FDA-EN Rev: 2017JAN24...
- Page 2 It should not be used for the diagnosis of or screening of diabetes or used on neonates. BLE Smart Control Solution is for use with the BLE Smart Meter and BLE Smart Test Strips only. Control solution is used to confirm the meter and test strips are working together properly.
- Page 3 *Infection Prevention during Blood Glucose Monitoring and Insulin Administration http://www.cdc.gov/injectionsafety/blood-glucose-monitoring. html Close supervision is required when BLE Smart is used by, on, or near children, handicapped or disabled individuals. Do not place the meter in liquid. Keep meter dry at all times. If the equipment becomes wet, remove the batteries and allow to dry thoroughly.
- Page 4 • In altitudes higher than 10,000, test results may be affected. OTHER LIMITATIONS AND INTERFERENCES BLE Smart test strip results can be used with hematocrit levels in the range of 25% to 65%. If your hematocrit range is out of the range (25%~65%), your test results may be lower or higher than the actual value.
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Page 5: Table Of Contents
• Do not use during or soon after xylose absorption testing. Xylose in the blood will cause interference. • Icodextrin does not interfere with BLE Smart test strips. TABLE OF CONTENTS About Your BLE Smart Blood Glucose Monitoring System......4-7 BLE Smart Kit contents................4 BLE Smart Meter..................5... -
Page 6: Ble Smart Meter
USA +1-877-458-2646; International +1-619-684-6232 Email - support@entrahealth.com Your BLE Smart System packaging is sealed to protect the contents. If you find your seal is broken, please return it to the place of purchase. BLE Smart Meter (Front side) Test Strip Port: Insert the BLE Smart test strip here. -
Page 7: Ble Smart Meter Display
BLE Smart Meter (Back side) Test Strip Ejector: Releases and discards test strip. Serial Number Battery Cover BLE Smart Meter display After Having a Meal After Taking Medication After Sport Activity\ ID CODE mmol/L mg/dL AVG CHK Control Solution Symbol... -
Page 8: Ble Smart Blood Glucose Test Strip
Do not use the BLE Smart Monitoring System in direct sunlight. WARNING: 1. BLE Smart meter and reusable lancing device is for single patient use only. 2. Always use a new sterile lancet and a new blood glucose test strip. -
Page 9: Comparing Your Meter And Laboratory Results
Initial meter set-up The BLE Smart meter has a wide variety of functions. In the setup mode you have the ability to turn ON or OFF activity/meal flags, set the date/time, adjust the number of days for your glucose average calculation and set up... - Page 10 to five daily alarms. Settings: Year, Activity, Date/Time, Temperature, Average Glucose, Alarms and Sending a Reading The year can range from 2015 to 2099. Power On User Activity Year Press Option Press and release the same time for Press and release buttons 3 seconds or until buttons...
- Page 11 The meter default settings are 7 days, 14 and 21 days. Precaution 1. Your BLE Smart Meter is pre-set to measure in mg/dL by default. If you need your meter set to another unit of measure (mmol/L), please contact Customer Support.
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Page 12: Performing A Control Solution Test
Performing a Control Solution Test Refer to the BLE Smart Control Solution Instructions for Use. Control solution contains a known amount of glucose that reacts with the BLE Smart Test Strip. By comparing your control solution test results with the expected range printed on the test strip vial, you can verify the meter and test strips are working properly, and you are performing the test properly. - Page 13 A control solution test should be performed: • Whenever you suspect the blood glucose test meter or blood glucose test strip are not functioning properly. • If your blood glucose test results are not consistent with your symptoms or if you think they are not accurate. •...
- Page 14 Control Solution (LOW) XX-XX X.X-X.X XX-XXX X.X-X.X BLE Smart Control Solution XXX-XXX XX.X-XX.X (NORMAL) BLE Smart Control Solution (HIGH) NOTE: The ranges pictured above are examples only. Please refer to your BLE Smart test strip vial label for the exact ranges.
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Page 15: Performing A Blood Glucose Test
• Check the expiration dates on all the products you are using. Be sure you are using only BLE Smart control solution. • After following the appropriate steps and the control solution test still falls out of range, do not perform a glucose test. - Page 16 Er5 message will appear on the screen. Begin your test from the beginning with a new test strip. SAFETY WARNING 1. BLE Smart meter and reusable lancing device are for single patient use only. Do not share your supplies with anyone, including other family members.
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Page 17: Using The Lancing Device
2. All parts of the kit are considered to be bio-hazardous and can potentially transmit infectious disease, even after cleaning and disinfection. 3. Refer to the cleaning and disinfecting your BLE Smart Monitoring System on Page 10. 4. Wash your hands thoroughly with soap and clean water after handling the meter, reusable lancing device and/or test strip. -
Page 18: Filling The Test Strip
5. Adjust the depth setting: 1-2 for soft skin 3-4 for average skin 5 for thick or calloused skin. 6. Pull back on the end of the lancet device to prepare for lancing. 7. Place the lancing device on the skin and hold firmly. Press the release button to activate. -
Page 19: Getting Your Results
IMPORTANT 1. If the countdown does not start, do not add more blood to the glucose test strip. Discard the glucose test strip and begin the test procedure again. 2. If you do not conduct the test within 3 minutes, the meter will automatically power OFF. -
Page 20: Safe Disposal Of Used Test Strips And Lancets
• Eject the test strip to automatically begin Bluetooth transmission to your phone, tablet or laptop. When the meter successfully pairs to a device it will display a “C” to confirm the paired and connected status. SAFE DISPOSAL OF USED TEST STRIPS AND LANCETS Once the test is complete, push the strip ejector button forward to remove the test strip from the meter. -
Page 21: Reviewing Your Blood Sugar Test Results
Reviewing Your Blood Sugar Test Results The BLE Smart meter stores up to 365 test results in its memory, along with the average glucose levels for the number of days, which you have pre-selected during the Meter Set-Up procedure, or if you left the default settings of 7 day, 14 and 21 day averages. -
Page 22: Alternate Site Testing
The average from The average from The average from 7 days worth of 14 days worth of 21 days worth of data from your data from your data from your recent test date. recent test date. recent test date. Average Test Result Test Unit The Number of Tests Average Test Result Days... - Page 23 SAFETY AND PRECAUTIONS • Alternative site testing may be performed from your forearm, upper arm, palm (ventral palm or dorsal hand), fingertips, thigh or calf. • Under certain conditions, blood glucose test results obtained using samples taken from your alternative sites may differ significantly from fingertip samples.
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Page 24: Cleaning And Disinfection
CLEANING AND DISINFECTION It is recommended the BLE Smart meter and the reusable lancing device be cleaned and disinfected once per day at minimum. Blood Glucose Meters and reusable lancing devices may be contaminated with bloodborne pathogens such as Hepatitis A, B or C Virus. -
Page 25: Storage Conditions
through major medical distributors and online shopping websites (ex. www. amazon.com or www.staples.com). Please refer to the disinfectant labeling for additional instructions or contact your health care professional for assistance. Precaution Take extreme care liquid does not soak into the data ports. Do not use any type of spray. -
Page 26: Bluetooth Wireless Data Transmission
Android, with operating systems 4.0 or higher. BATTERY INSTALLATION Slide open the battery compartment on the backside of the meter. Your BLE Smart Meter uses two 3V coin batteries (CR2032), which are included. When replacing the batteries, only CR2032 or equivalent coin batteries should be used. -
Page 27: Troubleshooting Your Meter
to alert you when the battery power is low. Install new batteries when low battery icon flashes. TROUBLESHOOTING YOUR METER Safety Precaution Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries appropriately. Safety Warning Do not make treatment decisions based on an error message. - Page 28 Message What it means Action required Blood glucose test Please insert a new glucose strip is damaged. test strip and perform your test again. Blood sample is Wait for the meter to display the placed on the test blinking blood drop symbol for strip before the test before applying your blood symbol for test...
- Page 29 Message What it means Action required Appears when the result is below measurment limit, which is less than 20mg/ The test should be repeated to ensure that the test procedure The test result is was done correctly. If you are less than 20mg/dL.
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Page 30: Myhealthpoint Account Set-Up
Message What it means Action required Not enough readings in the memory to display designated averages. The glucose The batteries are Change the batteries and test meter dead or there is a if the problem persists, does not turn problem with the contact your local meter. -
Page 31: Warranty
Customer Support. Toll Free: USA & Canada +1-877-458- 2646 or +1-619-684-6232 (International) or email support@entrahealth.com The BLE Smart meter uploads readings on MYHEALTHPOINT Patient ® portal by transmitting them via a paired Bluetooth mobile device. The user can see the most recent uploaded reading on the app screen once the results are transmitted successfully. -
Page 32: Declaration Of Conformity
Purchaser may contact the customer support, by calling toll free USA & Canada +1-877-458-2646 or International +1-619-684-6232 for assistance or email support@entrahealth.com IMPORTANT In order for Customer Support to assist you with a problem, be sure to have your meter, test strips and control solution nearby when you call for assistance. - Page 33 Running 1,000 times Bluetooth Bluetooth (Bluetooth Low Energy) Entra Health Copyright 2017. BLE Smart is a registered trademark. Manufactured by: Infopia Co., Ltd. Made in Korea Distributed by: Entra Health, A CRF Health Company 1300 North Johnson Avenue, Suite 100...
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