Entra Health System BLE Smart Скачать руководство пользователя

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IMPORTANT

Before using the BLE Smart Blood Glucose Monitoring System for the

first time, read all instructions for use and this User Manual. Consult your

Healthcare Professional to manage your diabetes daily with the BLE Smart

Blood Glucose Monitoring System.

OUR COMMITMENT TO YOU

We understand that self-testing your blood sugar levels provides a way for

you to control your diabetes. As a result, the BLE Smart Blood Glucose

Monitoring System was developed to help you manage your diabetes by the

most comfortable and convenient way possible. Our goal at Entra Health is

to provide you with the best quality products and superior customer service.

If you have any questions or comments, please visit our website at

www.entrahealth.com.

Please contact Customer Support by telephone at +1-877-458-2646 (USA) or

+1-619-684-6232 (International) or by email: [email protected]

INDICATIONS FOR USE

The BLE Smart Blood Glucose Monitoring System (“BLE Smart”) is

comprised of the BLE Smart Meter (with Bluetooth upload capability), BLE

Smart Control Solution, BLE Smart Test Strips and reusable Lancing Device.

The system is intended for the quantitative measurement of glucose (sugar)

in fresh capillary whole blood. Fresh capillary whole blood samples may be

drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf

and/or thigh. Alternative site testing should be done during steady–state times

(when glucose is not changing rapidly).

BLE Smart Blood Glucose Monitoring System is intended to be used by a

single patient and should not be shared with others.

BLE Smart Blood Glucose Monitoring System is intended for testing outside

the body (in vitro diagnostic use) by people with diabetes at home as an aid

to monitor the effectiveness of diabetes control. 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.

WARNINGS AND SAFETY INSTRUCTIONS

The Centers for Disease Control and Prevention (CDC) and the US Food and

Drug Administration (FDA) have become increasingly concerned about the

risks for transmitting hepatitis B virus (HBV) and other blood borne pathogens

from shared use of fingerstick (lancing) devices and blood glucose meters.

Содержание BLE Smart

Страница 1: ...BLE Smart Blood Glucose Monitoring System USER MANUAL P N MU BLE FDA EN Rev 2017JAN24 ...

Страница 2: ...ble Lancing Device The system is intended for the quantitative measurement of glucose sugar in fresh capillary whole blood Fresh capillary whole blood samples may be drawn from the fingertips ventral palm dorsal hand upper arm forearm calf and or thigh Alternative site testing should be done during steady state times when glucose is not changing rapidly BLE Smart Blood Glucose Monitoring System is...

Страница 3: ...evices DeviceRegulationandGuidance GuidanceDocuments ucm234577 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens February 2011 http www cdc gov injectionsafety Fingerstick DevicesBGM html Infection Prevention during Blood Glucose Monitoring and Insulin Administration http www cdc gov injectionsafety blood glucose monitorin...

Страница 4: ...e observed Use only BLE Smart test strips with the BLE Smart meter Use fresh capillary whole blood only Test strips are for single use only Do not reuse Dehydration may cause higher glucose test results Inaccurate results may occur when in shock during illness hypotensive hyperglycemic or hyperosmolar state with or without ketosis Critically ill patients should not be tested with this meter In alt...

Страница 5: ... test with your fingertip 14 Using the lancing device 16 Filling the test strip 17 Getting your results 18 Safe Disposal of used Test Strips and Lancets 19 Reviewing Your Test Results 19 21 Range of Expected Values 19 Reviewing Your Blood Sugar Test Results 20 Reviewing Your Averages 20 Alternate Site Testing 21 23 Cleaning and Disinfection 23 24 Storage Conditions 24 25 Bluetooth Wireless Data Tr...

Страница 6: ...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 Display Screen Displays your test results symbols and messages Power Enter Button Powers the meter on off prompts me...

Страница 7: ...ol Lmg dL IDCODE AVG CHK Low Battery Warning Symbol Alarm Symbol Troubleshooting Symbol Delete Results Average Test Result System Before Having a Meal After Having a Meal After Taking Medication After Sport Activity Control Solution Symbol Blood Drop Symbol for Test User ID Symbol Test Strip Code Symbol Test Result Unit Symbol Temperature Date Time Test Result Amount ...

Страница 8: ...rom one temperature to another allow 30 minutes for the meter to adjust to the new temperature before testing 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 3 Lancets and blood glucose test strips are for single use only and should...

Страница 9: ...ge it may result in a false high blood sugar result It s recommended to repeat the test in a warmer environment with a new test strip For additional information on possible limitations for validity and precision please refer to your BLE Smart test strip insert In order to make the most accurate comparison to your laboratory results please follow a few basic guidelines Before going to the lab Do no...

Страница 10: ...y pressing Date Time Use the or buttons to set the date and time Confirm both by pressing Temperature To view the ambient temperature in F or C use the or buttons Confirm by pressing Year Press and release the or buttons to set the year Confirm by pressing Power On Press and at the same time for 3 seconds or until the meter beeps Number of days for average Use the or buttons to set the number of d...

Страница 11: ...ealth com 2 If the Date is not set properly the average glucose test results in the memory will not calculate the proper values It is recommended you set up the glucose meter before you use it and when new batteries are installed 3 Blood glucose testing cannot be performed while in Set up mode 4 To turn the meter off during the set up press and hold for 5 seconds or until the meter beeps Alarm tim...

Страница 12: ... 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 It is very important to perform a control solution test routinely to ensure accurate results and to confirm proper performance of the system CODE 11 30 7 17 AM DATE 17 1 BLE Smart Meter has automatic test strip code recognition 2 The BLE Smart Meter ...

Страница 13: ...w pointed toward the meter and visible from the front of the meter NOTE Do not insert the test strip upside down 2 When you insert the test strip into meter port the meter will automatically turn ON and the test strip code will be displayed 3 Check the expiration date before performing a control solution test Make a note of the expiration date on the control solution bottle when first opened Do no...

Страница 14: ...e with control solution and an actual blood test NOTE The ranges pictured above are examples only Please refer to your BLE Smart test strip vial label for the exact ranges 7 If the user activity meal feature is ON Scroll through the icons with the or buttons until the control solution bottle blinks then press 8 If the activity meal feature is OFF Press and release either the or button The control ...

Страница 15: ...owing the appropriate steps and the control solution test still falls out of range do not perform a glucose test Contact customer support USA Canada 1 877 458 2646 International 1 619 684 6232 or email support entrahealth com PERFORMING A BLOOD GLUCOSE TEST Performing a blood test with your fingertip 1 With the meter OFF firmly insert the test strip into the test strip port on the meter with the a...

Страница 16: ...ncluding other family members 4 A blinking test strip will appear in the top right corner indicating the meter is ready for testing 7 If the user activity meal feature is OFF then your test result will display in five 5 seconds 5 Lance the clean fingertip with the lancing device BLE Smart meter requires 0 5 ul sample volume only Bring the edge of the test strip to the drop of blood The blood will ...

Страница 17: ... 4 Wash your hands thoroughly with soap and clean water after handling the meter reusable lancing device and or test strip Using the Lancing Device Follow the Lancing Device Instructions for Use prior to using 1 Unscrew the cap of the reusable lancing device 2 Insert a new sterile lancet into the reusable lancing device 3 Twist off the protective cover Do not discard 4 Put the cap back on the lanc...

Страница 18: ...ton to activate Remove the device to collect the blood sample 6 Pull back on the end of the lancet device to prepare for lancing 8 If the blood smears or runs wipe away and gently squeeze another drop or puncture a new site Filling the Test Strip INCORRECT COMPLETELY FILLED Incorrectly Filled Do Not Apply Blood to Top of Strip Correctly Filled Applying Blood to End of Strip ...

Страница 19: ...ple Precaution 1 If the test result is out of the test range the Hi Lo message will be displayed on the meter Repeat the test and if Hi Lo message persists contact Customer Support 2 Used blood glucose test materials may contain blood borne pathogens that could transmit disease to others Please contact your Healthcare Provider for instructions on disposal of your glucose test strips and lancets Yo...

Страница 20: ...es Association Diabetes Care 2015 38 Supplement 1 S8 S16 c 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 Unscrew the cap of the lancing device and push the needle into the protective cover that was removed during preparation of the lancet ...

Страница 21: ...ur system with control solution If you experience symptoms that are not consistent with your glucose results review and try test procedure again from the beginning If you continue to experience unexpected results or if you have symptoms contact your health care professional immediately Reviewing Your Blood Sugar Test Results The BLE Smart meter stores up to 365 test results in its memory along wit...

Страница 22: ...t test date The average from 14 days worth of data from your recent test date The average from 21 days worth of data from your recent test date Average Test Result Test Unit The Number of Tests Average Test Result Days Calf Thigh Ventral Palm Forearm Upper Arm Dorsal Hand Fingertips ...

Страница 23: ...insulin doses or physical exercise Testing performed within two hours after meals insulin doses or physical exercise or whenever you feel your glucose levels may be changing rapidly should be done from the fingertip Always use fingertip testing whenever you have a concern about hypoglycemia insulin reactions particularly if you suffer from hypoglycemic unawareness lack of symptom to indicate as in...

Страница 24: ...ip instead You may want to review the choice of sites with your Healthcare Professional CAUTION Do not test on your upper arm forearm dorsal hand ventral palm thigh or calf when you think your blood glucose is rapidly falling For example within two hours of exercise following a rapid action insulin injection or an insulin pump bolus or when testing with a fingertip sample may identify a potential ...

Страница 25: ...F during cleaning and disinfecting 3 It s okay to remove the batteries during cleaning and disinfecting procedures 4 Be sure to allow the meter and lancing device to dry thoroughly after cleaning and disinfecting 5 Replace batteries if removed during the procedure STORAGE CONDITIONS Meter Storage Operating temperature is 4 104 F 20 40 C Always store or transport the meter in its original storage c...

Страница 26: ...elessly to Bluetooth enabled Smartphones and Tablets This option is for 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 NOTE Verify the date and time is correc...

Страница 27: ...ar please contact customer support Do not attempt to disassemble the meter or repair yourself ERRORS Message What it means Action required Hardware is defective Test strip may be contaminated or used Reboot the meter by removing and replacing the meter with new batteries Make sure that the test strip is not inserted into the meter If the problem persists please contact customer support Please inse...

Страница 28: ...ain Wait for the meter to display the blinking blood drop symbol for test before applying your blood sample 1 Please insert a new glucose test strip and perform your test again or if it blinks with sun avoid direct sunlight and retest Contact your local representative or customer support if the problem persists 2 Please insert the correct glucose test strip Place the meter at a temperature between...

Страница 29: ...istently measured as HI the result may indicate severe hyperglycemia high blood glucose You should inform your Healthcare Professional immediately The test result is less than 20mg dL Appears when the result is below measurment limit which is less than 20mg dL The test should be repeated to ensure that the test procedure was done correctly If you are certain the meter is functioning correctly and ...

Страница 30: ...nt amount of blood There may be a problem with the glucose test strips The glucose test meter does not start after applying the blood sample The results are inconsistent Please insert a new test strip and perform your test again Please insert a new test strip and perform your test again MYHEALTHPOINT ACCOUNT SET UP The MyHealthPoint Portal is an extensive communication and data management web site...

Страница 31: ... the app screen once the results are transmitted successfully STEP 1 NEW MEMBER REGISTRATION on MYHEALTHPOINT When you set up your membership account on the myhealthpoint com website your meter will automatically transmit your blood glucose test results via the bluetooth connection STEP 2 LOG IN to MYHEALTHPOINT using the log in and password you created during New Member Registration WARRANTY Entr...

Страница 32: ...protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interferenc...

Страница 33: ...entrahealth com support entrahealth com Hematocrit 25 65 Altitude 3 048m 10 000 feet Operating Temperature 50 104 F 10 40 C Operating Humidity 10 90 Strip storage temperature 36 86 F 2 30 C Strip storage humidity 10 85 RH Display Type LCD with Backlight Coding Auto coding Memory 365 test results Dimension 3 8x2 2x0 9 in 96 X 56 X 24 1 mm Weight Including Battery 65 1g Power Source 3V Li Battery CR...

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