Fego Precision Co FPG2003B FEGO BLE GlucoPedo Pedometer and Blood Glucose Monitoring System User Manual Rev 01 150129
Fego Precision Industrial Co Ltd FEGO BLE GlucoPedo Pedometer and Blood Glucose Monitoring System Rev 01 150129
User Manual-Rev.01(150129)
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| Document ID | 2522820 |
| Application ID | 6pbYXF+iwJYJZZ+RaIaHDw== |
| Document Description | User Manual-Rev.01(150129) |
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| Document Type | User Manual |
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| Filesize | 247.11kB (3088839 bits) |
| Date Submitted | 2015-02-04 00:00:00 |
| Date Available | 2015-02-04 00:00:00 |
| Creation Date | 2015-01-20 17:09:52 |
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| Document Lastmod | 2015-01-29 13:11:47 |
| Document Title | Microsoft Word - BLE_GLUCO_PEDO_EN_V0.13_150120.doc |
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| Document Author: | WH_Hsieh |
FEGO BLE GlucoPedo Pedometer and Blood Glucose Monitoring system User Guide Table of Content Introduction ................................................... 2 Principle of Measurement ..................... 11 FEDERAL COMMUNICATIONS Performance Characteristics ................. 12 COMMISSION INTERFERENCE STATEMENT About Alternative Site Testing ............. 12 .......................................................................... 3 Prepare For Blood Sampling................. 13 Getting to Know Your System .................. .4 Performing Blood Test........................... 14 Intended Use............................................. 4 Blood Glucose Memory Recall ............. 18 Meter.......................................................... 4 Receive your blood glucose measurement test LCD Screen Display................................. 5 data from the phone APP........................... 17 Blood Glucose Test Strip......................... 6 Understanding Your Blood Glucose Battery........................................................ 6 Levels........................................................ 17 Setting You Meter ......................................... 7 Control Solution Test ............................. 18 Step Counter .................................................. 8 Caring for Your Meter and Test Strip.. 20 Before Using the Step Counter............... 8 Bluetooth 4.0 BLE function ........................ 22 Step Counting Mode ............................... 8 Display Messages........................................ 22 Receive your pedometer test data from the System Specifications................................. 25 phone APP ........................................................ 9 Symbol Description .................................... 26 Blood Glucose Test..................................... 10 Dealer / Manufacturer Information ......... 28 Before Using the Blood Glucose Meter10 Introduction Thank you for choosing BLE GlucoPedo. The BLE GlucoPedo system allows you to record daily steps, measure your blood glucose values, and use as a USB driver. Please read all instructions carefully before use. To ensure you operate the BLE GlucoPedo correctly to measure the accurate blood glucose (blood sugar), read all instructions thoroughly and practice the test. Call your local agent or contact our sales representative if you have any question. IMPORTANT SAFETY INFORMATION Please read all instructions before use and follow below precautions. Use the device only for the intended use described in this manual. The product has measurement and record function. If the time and date are not set correctly, the data might get loss or error. Please set the current time and date correctly before use. Time setting is guided in the manual. No modification is allowed on the product. If the electromagnetic field is too strong, it will interfere with the correct operation of BLE GlucoPedo. Do not use the product at a place close to strong electromagnetic radiation. To avoid the generation of static electricity, please do not use the product in a very dry environment, especially in the artificial synthetic material environment. Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. Please discard the product properly according to the regulations of your country. Do not use the device if it is not working properly, or if it has suffered any damage. CAUTION： Please keep all small parts out of the reach of children. The bottle cap, the test strip, and the lancets may cause a choking hazard. Please do not swallow. Go to the doctor immediately if accidentally swallowed. Keep the user guide in case of emergency. FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable 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 interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more 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. -- Consult the dealer or an experienced radio/TV technician for help. CAUTION: To assure continued FCC compliance: 1. Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. FCC Label Compliance Statement: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Getting to Know Your System The BLE GlucoPedo is for recording personal daily blood glucose and recording daily walking steps. Intended use The glucose test function in BLE GlucoPedo is intended for use outside of the body self-testing (in vitro diagnostic use only). It should be used only for testing blood glucose (blood sugar) and only with fresh capillary whole blood samples. The system should not be used for the diagnosis of diabetes or for the testing of newborns. It can use in the home and in clinical settings. This pedometer function in BLE GlucoPedo counts and stores the number of steps (0~100000 steps), the covered distance (distance measurements 0~9999.99 KM) and the calories burnt (0~9999.99 KCAL) hereby. This product is not suitable for commercial, industrial or medical use. Meter Description of the buttons ：MENU Button Power on/off: Turn on / off the pedometer by pressing and hold the button for 3 seconds. Standby mode－Short press to switch the figures display sequentially in Step→ Calorie→ Distance→ Blood Glucose→ Date. Setting mode－the button is the enter function. Set year→ month→ date→12/24 hours → hour → minute→ second sequentially. ：UP/DOWN Button Press UP + DOWN buttons together for 5 seconds to enter setting mode to set date and time. ：UP button Memory mode: Press to navigate between the blood glucose test records. Setting mode: Short press to increase value and long press for rapidly increase value. ：DOWN Button Memory mode: Press to navigate between the blood glucose test records. Setting mode: Short press to decrease value and long press for rapidly decrease value. LCD Screen Display (1) Main window：Shows glucose/temperature/steps/calories/distance/date/error message. (2) Bluetooth status: the left symbol flashes indicates no connection with the phone, constant light for the connection, and turns off the Bluetooth function is turned off; arrow symbol constant light indicates data is being transmitted. (3) mg/dL：Unit of measure for blood glucose. Displays with blood glucose test results. (4) Memory icon：Displays when the meter is in blood glucose memory mode. (5) USB symbol: When connected to a computer or other USB charging device for displaying the main window displays the date. (6) STEP：Unit of measure for step counter. Displays when the meter is showing the step counter. (7) KCAL：Unit of measure for calories (kilocalorie). Displays when the meter is showing the value of consumed calories. (8) KM：Unit of measure for distance (kilometer). Displays when the meter is showing the value of consumed calories. (9) Battery icon：Displays when the meter power is low. Charge the battery immediately by connecting the meter to a computer with its USB connector. The charging is complete when the icon stops flashing (while connecting to a computer). (10) 12-hour display: When the time is set to 12-hour display. (11) Time display window：The window displays time. In memory mode, it alternately shows date and time of the glucose test result. (12) Test strip icon：Displays when a test strip is inserted to the meter. (13) Blood icon：Flashes when the test strip is ready for blood sample to be applied. Do not apply blood until this icon shows up. Blood Glucose Test Strip Battery Charge the battery before your first use of the BLE GlucoPedo meter by plugging the USB connector to a computer or other USB charger. Charge for at least 2.5 hours or until the battery icon displays all the time without flashing. Charge the battery when the low battery icon Please keep away from high temperature when charging. Please contact the agent or sales representative if the battery icon is still flashing after 3 displays. hours charging. The battery of this product is not intended to be changed. Setting Your Meter Before using the BLE GlucoPedo for the first time, please set the correct date and time to keep correct records of daily steps and blood glucose values. To enter setting mode, turn on the meter first by pressing MENU Button press for 3 seconds, and buttons together for 5 seconds. Turn on the meter Turn on the meter first by pressing MENU button for 3 seconds, and the meter is now in standby mode. Enter setting mode Press buttons together for 5 seconds until the number of the year is flashing. Set the year Press or to navigate the value, and press to confirm and move on to the next setting. Set the month Press or to navigate to the current year. Press to confirm and move on to the next setting. Set the date Press or month. Press to navigate to the current to confirm and move on to the next setting. Set the hour format Press or to navigate to your preferred hour format (24 hr/12 hr). Press to confirm and move on to the next setting. Set the hour Press or to navigate to the current hour. Press to confirm and move on to the next setting. Set the minute Press or minute. Press next setting. to navigate to the current to confirm and move on to the 1. Set the second Press or to navigate to the current second. Press to confirm and return to standby mode. Step Counter Before Using the Step Counter The step counter automatically returns to zero every day. Make sure you have set the meter date and time to keep a correct record of your daily steps; refer to Setting Your Meter chapter for details. BLE GlucoPedo use triaxial accelerometer sensor which detects changes in acceleration. The number of steps walked are measured based on the vertical movement. Take care to affix the device securely near your waist line into a suitable location such as a pocket or belt pouches etc. Step Counting Mode 1. Turn the meter on by pressing MENU Button for 3 seconds, and the meter is in standby mode, showing the number of steps today. 2. After consecutive walks (8 steps), the meter starts the pedometer function. 3. Press button to switch the display data to calories. 4. Press button to switch the display data to distance. 5. Press button to switch to blood glucose value display. For details of blood glucose measuring, refer to Blood Glucose Test chapter. 6. Press button to switch to date display. Receive your pedometer test data from the phone APP To receive a pedometer, please open the following FEGO BLE Communication Protocol compatible mobile phone or tablet terminal APP, pedometer data will be transmitted via a fixed time BLE to the phone side. 10 Blood Glucose Test Before Using the Blood Glucose Meter Before using the product to test your blood glucose value, read all instructions thoroughly and practice the test by using the control solution. Do all quality control checks as directed. Make sure you have set the correct date and time for the meter; refer to Setting Your Meter chapter for details. CAUTION： ： To measure the accurate glucose value, please do not use test strips and control solutions which are not supplied by the manufacturer. CAUTION The measured blood glucose is for reference only. It is not to be used for the diagnosis of diabetes. The user should not take any decision of medical relevance by the meter. Please consult the doctor or medical practitioner for further instructions. If you experience symptoms that are not consistent with your blood glucose test result, please repeat the test. If the second test result is still inconsistent, please call your doctor immediately. If the blood contains high concentrations of vitamin C, uric acid or other reducing substances, it may cause inaccurate measurement result. Please consult a physician before testing. High attitudes above than 3,402 meter (11,161ft) may affect the test result. Temperatures outside the range of 10°C to 40°C (50°F to 104°F) may affect the test results. Do not test beyond of temperature range. Important health information Apply only capillary whole blood sample to test your blood glucose. Applying other substances or plasma, serum will cause wrong results. Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your healthcare professional immediately. Test results below 60 mg/dL (3.3 mmol/L)*1 indicates low blood glucose (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L)*2 indicates high blood glucose (hyperglycemia).If your results are below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), repeat the test, and if the results are still below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare professional immediately. Inaccurate results may occur in severely hypertensive 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. Abnormal red blood cell counts (hematocrit level below 20% or above 60%) may cause false 11 results. Please consult your healthcare professional if you do not know your hematocrit level. Interference： Reducing substances occurring in the blood naturally (say, uric acid) or from therapeutic treatments (ascorbic acid, acetaminophen) will not significantly affect BLE GlucoPedo test results. However, elevated concentrations of these substances may affect test results. The compounds listed in the table were found to have no affect at the concentration indicated Compounds Reference 1 Press, 2007. Reference 2 Highest concentrations tested at which no interference occurred Acetaminophen ≦ 8.0 mg/dL (0.53 mmol/L) ≦ 5.0 mg/dL (0.28 mmol/L) Ascorbic Acid ≦ 60 mg/dL (3.33 mmol/L) Aspirin ≦ 90 mg/dL (1.54 mmol/L) Bilirubin ≦ 500 mg/dL (12.9 mmol/L) Cholesterol ≦ 5.0 mg/dL (0.44 mmol/L) Creatinine ≦ 2.0 mg/dL (0.11 mmol/L) Dopamine ≦ 360 mg/dL (12.3 mmol/L) EDTA ≦ 900 mg/dL (50 mmol/L) Galactose ≦ 5.0 mg/dL (0.32 mmol/L) Gentisic Acid ≦ 53 mg/dL (1.72 mmol/L) Glutathione ≦ 500 mg/dL (0.08 mmol/L) Haemoglobin ≦ 8,000 U/dL Heparin ≦ 3.0 mg/dL (0.39 mmol/L) Hydroxyurea ≦ 50 mg/dL (2.42 mmol/L) Ibuprofen ≦ 13 mg/dL (0.01 mmol/L) Icodextrin ≦ 10 mg/dL (0.51 mmol/L) L-dopa ≦ 900 mg/dL (26.3 mmol/L) Maltose ≦ 3.0 mg/dL (0.13 mmol/L) Methyldopa ≦ 25 mg/dL (0.94 mmol/L) Pralidoxime ≦ 60 mg/dL (4.34 mmol/L) Salicylate ≦ 100 mg/dL (3.21 mmol/L) Tolazamide ≦ 400 mg/dL (14.8 mmol/L) Tolbutamide ≦ 2,000 mg/dL (22.6 mmol/L) Triglycerides ≦ 8.0 mg/dL (0.48 mmol/L) Uric Acid ≦ 100 mg/dL (6.66 mmol/L) Xylose Please read test strip instruction carefully. ： Jabbour, Serge, Elizabeth A. Stephens, Irl Bennett Hirsch. Type 1 Diabetes in Adults. USA： CRC ： Unger, Jeff. Diabetes Management in Primary Care. USA： Lippincott Williams & Wilkins, 2006. Principle of Blood Glucose Measurement Blood glucose is measured by an electrical current that is produced when a blood sample mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. The BLE GlucoPedo measures the strength of the electrical current, calculates your blood glucose level and then displays your result in 12 milligrams of glucose per deciliter (mg/dL). Performance Characteristics for Blood Glucose Test The BLE GlucoPedo adopts state-of-the-art technology to measure blood sugar easily and comfortably. The required amount of blood is less than 0.7 μL. It tests and displays the glucose value in 6 seconds. ACCURACY : 95 % of the measured glucose values were within either ±15 mg/dL (± 0.83 mmol/L) of the average measured values of the reference measurement procedure at glucose concentrations <100 mg/dL (< 5.55 mmol/L) or within ± 15 % at glucose concentrations ≧ 100 mg/dL ( ≧ 5.55 mmol/L). PRECISION: CVs (%) of intermediate precision and repeatability were less than 5%. About Alternative Site for Blood Glucose Testing (AST) There are important limitations for doing AST. Please consult your healthcare professional before you perform AST. What is AST? Alternative Site Testing (AST) means you can use parts of the body other than your fingertips to check your blood glucose levels. The BLE GlucoPedo meter allows you to test your palm, forearm, upper arm, calf, or thigh with equivalent results to fingertip testing. What is the advantage? Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body sites, nerve endings are not so numerous and you will not feel as much pain as you will experience at the fingertip. When to use AST? Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at fingertip reflects these changes faster than capillary blood at other sites. Therefore, if you are testing blood glucose level during or immediately after meal, physical exercise or stressful event, take the blood sample from your fingertip only. Use AST only: In a pre-meal or fasting state (more than 2 hours since the last meal). Two hours or more after taking insulin. Two hours or more after exercise. During steady state blood glucose conditions. Do NOT use AST if: 13 You have reason to believe you have hypoglycemia or hyperglycemia. Your routine glucose results are often fluctuating. You are pregnant. How to increase the accuracy? Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood from the site without rubbing exhibits a measurably different glucose concentration than blood from the fingertip. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced. Important: To increase the accuracy when using AST, rub the puncture site more than 20 seconds before extracting blood. Prepare For Blood Sampling Your lancing device and lancets are used for obtaining blood samples from the puncture site.。 Lancing Device Lancet Important Lancing Device and Lancets Information Lancet is for single use only。 Keep lancing device and lancets clean。 Use caution when removing the used lancet from the device and when disposing the used lancet. The meter and lancing device are for single patient use. Do NOT share them with anyone including other family members. 14 Do NOT use on multiple patients. Prepare For Blood Sampling STEP 1: Remove the cap of the lancing device by twisting it off. Insert a sterile lancet into the lancet holder of the lancing device and push down firmly until the lancet is fully seated. Do not twist the lancet. STEP 2 : Remove the protective cap from the lancet by twisting it and then save it for later use. STEP 3 : Replace the lancing device cap and set the puncture depth to the desired number. To select the best depth: 1-2: For soft or thin skin 3: For averag skin 4-5: For thick or callused skin STEP 4 : Pull back the cocking control until it makes a click, and then release. If it does not click, the device may have been cocked when the lancet was inserted. Performing Blood Test Wash Your Hands and the Puncture Site Wash your hands in warm, soapy water. Rinse and dry completely. Warm your fingers to increase blood flow。 Pull Out the Rubber Plug The strip slot is protected by the rubber plug. Pull out the rubber plug before inserting a test strip. 15 Insert Test Strip Remove a new test strip from vial. Be sure to tightly replace vial cap after removing test strips. Insert a test strip with the contact bar end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. Detecting Temperature After the meter is turned on by inserting the test strip, the meter detects ambient temperature and displays for 0.5 seconds, it enters scenario selection mode. Select the Measuring Scenario or Press button to navigate to your current status. AC: Before meal (default) PC-1: 2hr after breakfast PC-2: 2hr after lunch PC-3: 2hr after dinner Press button to confirm the selection. Ready for Blood Sample When the blood icon is flashing, the meter is ready to test your blood. Select and Lance a Puncture Site * For Fingertip Hold the lancing device firmly against the side of your finger. Press the release button. You will hear a click, indicating that the puncture is complete. * For AST Please refer to the “About Alternative Site Testing (AST)” section. Please consult your healthcare professional before obtaining blood from site other than your fingertip. Obtain a Blood Sample Gently massage your finger or puncture site to obtain the required blood volume. To perform the test, you need only 0.7 μL of blood sample. Do not smear the blood sample. To obtain best accurate result, wipe off the first drop of blood and gently squeeze another drop of blood. 16 Apply Blood Sample Apply the blood sample to the opening of absorbent channel of test strip until the confirmation window is fully covered with blood. Blood will be drawn into the test strip. If the test strip confirmation window is full, you will hear a beep, and the meter starts to count down from 6 to 1. Read Your Result After 6 seconds, the meter displays your blood glucose test result. Remove the Used Test Strip Your blood glucose result is automatically stored in the meter memory. Leave the Blood Glucose Mode by removing the test strip. Discard the used strip and lancet safely in a puncture resistant container. Remove the Used Lancet Remove the Lancing Device Cap. Push the Lancet Protective Cap back onto the exposed needle of the lancet. Direct the lancing device away from you and slide the Lancet Ejector in a forward motion, disposing the lancet in an approved container. 17 Blood Glucose Memory Recall The BLE GlucoPedo meter automatically stores 99 test results, letting you review them in order from the most recent to the oldest. You can either view your individual blood glucose test results on the meter or on a computer. View Your Blood Glucose Test Results on the Meter While the meter is turned on, press button shortly and repeatedly to navigate to memory mode. The meter shows the memory record number / test result / time and measuring scenario / date alternately. Press or to navigate the blood glucose test results. Receive your Blood Glucose Measurement test data from the phone APP To receive information on blood glucose measurements, turn follows FEGO BLE Communication Protocol compatible mobile terminal APP, blood glucose data will be measured after the completion of the transfer to the phone side by BLE. 18 Understanding Your Blood Glucose Levels The normal blood glucose range is below 100 mg/dL (5.6 mmol/L) for a fasting, nondiabetic adult, but less than 140 mg/dL (7.8 mmol/L) two hours after meals.* Consult your healthcare professional to find out your target blood glucose value. If your blood glucose result seems unusually high or low, or inconsistent with your previous results, check the following: 1. Was the blood sample applied immediately to the test strip after removing it from the vial? 2. Was the volume of the blood sample sufficient? 3. Was the test strip vial cap tightly sealed? 4. Was the test strip used before the expiration date? 5. Were the test strips stored away from extreme temperatures in very cold or hot weather or from areas of high humidity? Then run a control test with control solution. If the control test result is within the acceptable range, review testing procedure and repeat your blood glucose test with a new test strip. If your blood glucose value is still inconsistent with your previous results, glucose trend, or how you feel, contact your doctor immediately for help. Reference: * American Diabetes Association Website (http://www.diabetes.org) Control Solution Test If your FEGO control solution did not come with a FEGO Control Solution Insert, the following information shall take the place of the insert. Intended Use : The FEGO Control solution is a liquid containing a measured amount of glucose which reacts with the FEGO test strip and meter. Only for use with FEGO BLE GlucoPedo meter and test strips as a quality control measure to verify the accuracy of the blood glucose test results. The FEGO Control solution is for in vitro diagnostic use. Important Information : •Use only FEGO control solutions with your FEGO BLE GlucoPedo meter. •Check the expiration date on the bottle. Do not use if expired. •Use within a period of 90 days from the date that you first open it. Record the discard date on the control solution bottle when you first open it to serve as a reminder to discard after 90 days. •The control solution ranges are located on the back of the FEGO test strip vial. are not recommended target ranges for your blood glucose. •For in vitro diagnostic use. •Do not add any liquid to the FEGO Control Solution. •Do not take internally or inject. 19 They Why Perform a Control Solution Test : •To ensure that your meter and test strips are working properly together. •To allow you to practice testing without using your own blood. When to Use : •Once a week (to ensure that you continue to have accurate results). •When you begin using a new vial of test strips •When test strips have been exposed to extreme environmental conditions. •If you drop the meter. Storage and Handling: •Store the control solution tightly closed at temperatures between 4°C (39°F) and 30°C (86°F). •Do not refrigerate, freeze, heat or expose to direct sunlight. • Recap the bottle after use. Performing a Control Solution Test Wash Your Hands and the Puncture Site Wash your hands in warm, soapy water. Rinse and dry completely. Warm your fingers to increase blood flow。 Pull Out the Rubber Plug The strip slot is protected by the rubber plug. Pull out the rubber plug before inserting a test strip. Insert Test Strip Remove a new test strip from vial. Be sure to tightly replace vial cap after removing test strips. Insert a test strip with the contact bar end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. Detecting Temperature After the meter is turned on by inserting the test strip, the meter detects ambient temperature and displays for 0.5 seconds, it enters scenario selection mode. Select the Measuring Scenario Press button to confirm the default AC selection. When the blood icon is flashing, the meter is ready to perform a control solution test. 20 Apply Control Solution Check the expiration and discard dates on your control solution and test strip vials. Shake the control solution bottle well, then remove cap. Squeeze the bottle and discard the first drop then wipe the dispenser tip with clean tissue paper or cotton. Squeeze the bottle again to get a second drop onto a clean, non-absorbent surface or on your clean fingertip. Bring the tip of the test strip to touch the drop of solution until the meter beeps. Caution: To avoid contaminating the control solution with the content of the test strip, DO NOT DIRECTLY APPLY CONTROL SOLUTION ONTO THE TEST STRIP. Check if the Test Result is in Range. After six (6) seconds, the control solution test result appears on the display. Compare the test result with the range printed on the test strip vial. Each vial of FEGO Test Strips may have a different control solution range. The result should fall within the printed range on the test strip vial. Caring for Your Meter and Test Strip To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use. Cleaning Your meter does not require special maintenance. As long as no blood or control solution comes in direct contact with the meter, there is no special cleaning required. To clean the meter exterior, wipe with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth. Do not flush with water. Do not use organic solvents to clean the meter. Your meter is a precision instrument. Please handle it with care. Storage ◎Meter (BLE GlucoPedo) * Storage condition： -20ºC~50ºC (-4ºF~122ºF), below 90% relative humidity. * Avoid dropping and strong impact. * Avoid direct sunlight and humidity. 21 ◎Test Strip * Storage condition： 4ºC~40ºC (39ºF~104ºF), and 10~85% relative humidity. Do not refrigerate. * Store your test strips in their original vial only. Do not transfer to other container. * Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat. * After removing a test strip from the vial, immediately replace the vial cap and close it tightly. * You may touch the test strip anywhere with clean, dry hands when removing it from the vial or inserting it into the meter. * Use each test strip immediately after removing it from the vial. * Do not bend, cut, or alter a test strip in any way. * Keep the strip vial away from children since the cap and the test strip can be a potential choking hazard. If swallowed, please seek medical assistance immediately. ◎Control solution * Storage condition： Store the control solution tightly closed at temperatures 4ºC(39ºF )~30ºC (86ºF). * Do not refrigerate. Bluetooth 4.0 BLE function 1.Power OFF state under BLE disabled. Under 2.Power ON state, BLE enabled. 3. APP may end through FEGO BLE Communication Protocol compatible phone or tablet, receive information pedometer and blood glucose measurement data. 4. Through FEGO BLE Communication Protocol compatible phone or tablet terminal APP, set the timer on and time off BLE function. BLE function turned off, the pattern is not displayed. BLE feature enabled, the display phone or tablet, the pattern represents the connection with your blinking feature turned wait connection. When the function is activated and BLE connection, information being transferred to the phone or tablet. 22 display, said Display Messages The following is a summary of the display messages and symbols of Fego BLE GlucoPedo Meter. These messages help to identify certain problems but do not appear in all cases when a problem has occurred. Improper use may cause an inaccurate result without producing an error message. In the event of a problem, refer to information under "ACTION TO TAKE". DISPLAY DESCRIPTION ACTION TO TAKE All LCD segment on for display checking every time the test strip is inserted. All LCD segment on for If some parts of the display are not display checking. working. Contact your local distributor for help. Move BLE GlucoPedo to a place with temperature between 10° C - 40° C. Wait for 30 minutes before performing the test. If Display Temperature the display keeps staying in this mode, please contact local distributor for help. Select the scenario before the test： AC: Before meal Scenario Selection PC-1: 2hr after breakfast PC-2: 2hr after lunch PC-3: 2hr after dinner The meter is ready for blood sample Blinking Blood Drop Icon applying into the test strip 23 Please connect the phone or tablet were Data full immediately upload data through the BLE. Test result is higher than 600 mg/dL (33.3 mmol/L) If this is not confirmed by the way you feel, review proper testing procedure and perform a control test. Repeat blood test, if Test result is lower than 20 mg/dL (1.1 mmol/L) the display still appears, please call medical assistance immediately. Toggle Display 1. Record Counts / Blood Glucose Value / Display the last record Time 2. Scenario / Date The ambient temperature is higher than the allowed operating temperature The meter is not working. Move to an area range. with temperature between 10ºC to 40ºC The ambient temperature is (50ºF - 104ºF) and wait at least 30 minutes. lower than the allowed Do not artificially heat or cool the meter. operating temperature range. Possible Reason： Please 1. The test strip has been used or the test strip is wed. 1. Insert a new test strip. 2. Please contact local distributors or customer services for help. 2. The meter is defective. Please charge the BLE GlucoPedo meter as soon as possible by connecting it to a Battery is weak. computer 24 Please charge the BLE GlucoPedo meter as Battery is dead. soon as possible by connecting it to a computer Memory (EEPROM) is Please contact local distributors or defective. customer services for help. Please contact local distributors or System Error customer services for help. BLE GlucoPedo meter has no Possible Reason： response after the 1. Wrong strip is inserted. test strip is 3. Meter is defective Please 2. Insert FEGO test strip provided by us. 3. Contact local distributors or customer services for help. inserted BLE GlucoPedo meter does not Possible Reason： Please perform blood 1. The volume of the blood 1. Insert a new test strip and test again by glucose test after the blood sample is applied to the sample is not adequate. applying enough blood. 2. BLE GlucoPedo meter is defective. 2. Contact local distributors or customer services for help. test strip Nothing shown on LCD Please Possible Reason 1. Charge the device. 1. Run out of battery. 2. Press and hold 2. Power is off. 3. Contact local distributors or customer 3. Meter is defective. services for help. No calorie or distance value to turn on the meter. 1. Step counting function will be activated after 8 consecutive steps are detected. Possible Reason 1. No step is counted 2. If after 8 to 10 steps, the meter is still 2. meter is defective inactive. Please contact local distributors or customer services for help. 25 System Specifications General Information Model Name Model Number Display Content USB indicator Assay Method FEGO BLE Pedometer and Blood Glucose Monitoring System FPG2003B Blood Glucose / Step Counts / Distance / Calories / Time / Date/ BLE connection status Orange LED Blinking：accessing data Green LED：accessing data done Electrochemical biosensor 1. 3G Sensor Wakeup Method 2. Any Button 3. Insert The Test Strip Entering Sleep Mode Power Supply No activity for 10 seconds DC 3.7V(Maximum battery voltage of 4.2V rechargeable lithium battery x 1） 3.7V rechargeable lithium battery Battery Life Full charged state is enough for 500blood glucose tests or 10,000 steps per day. Low Battery Indicator 3.7V 1. 128KB EEPROM：Keep step counts and raw data for 1~2 Memory Capacity weeks if walk 10,000 steps daily (suggest to connect BLE GlucoPedo to computer to upload data to computer to release the memory on BLE GlucoPedo) LCD Size 32(L)x21mm(W) Dimensions 66.4 mm (L) x 31 mm (W) x 14.5 mm (H) Weight 27g Material PC/ABS Operating Condition for 4℃~+40℃，Humidity 10- 85%RH, Blood Glucose Testing Altitude≦ 3,402 m (11,161 ft) above the sea level. Storage/ Transportation Condition for Blood 4℃~+40℃，Humidity 10- 85%RH (with strip included) Glucose Testing Blood Glucose Manufacturer Warranty 1 Year Test Sample Capillary whole blood Test Result Calibration Referenced to plasma glucose value Sample Size 0.7μL Measuring Time 6 seconds 26 Measuring Range 20~600 mg/dL(1.1~33.3 mmol/L) Memory 99 test memories Acceptable Hematocrit Range 20~60% Steps Pedometer sensor 3G sensor Steps Range 0～100000 steps Distance Range 0.0～9999.99 Km Calories Range 0.0~9999.99 Kcal BLE 1.e-Signal SMD8105-A07-00A(AMICCOM A8105)Module。 2.Frequency Range: 2400 ~ 2483.5 MHz ISM (channel spacing is 1MHz). 3.Modulate mode: GFSK. 4.Support the application of data rate from 4Kbps to 2Mbps. BLE Bluetooth function 5.Using AES-128 CCM encryption algorithm. 6.All packets are using the 24-bit CRC checksum. 7.Automatically adapt to the fast frequency hopping. 8.Bluetooth 4.0 BLE SMART. 9.The state of motion and instant connection with the phone APP pedometer data transfer. 10.Glucose measurements done automatically transfer data. 27 Symbol Description For in vitro diagnostic use Please consult instructions for use USB Connection This product fulfils the requirements of Directive CE and IEC/EN 60601-1-2 standard in vitro diagnostic medical device. Caution, consult accompanying document Lot number Manufacturer Do not reuse Temperature limitation / Store at Use by / Expiry date Dealer / Manufacturer Information Dealer：Fego Precision Industrial Co., Ltd Dealer Address：947 Lin-Sen Rd. Wu-Fong Tai-Chung 413 Taiwan ROC Dealer Phone：+886-4-23391802 Pharmacist/Manufacture：OK Biotech Co., Ltd. Address：No. 91, Sec. 2, Gongdao 5th Rd., 30070 Hsinchu, TAIWAN MDSS GmbH Schiffgraben 41, 30175 Hannover, GERMANY 28
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