Sejoy BG-210b Owner'S Booklet Download Page 1

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Owner’s Booklet

BG-210b Blood Glucose Monitoring System

Advanced Diabetes Management System

Summary of Contents for BG-210b

Page 1: ...Owner s Booklet BG 210b Blood Glucose Monitoring System Advanced Diabetes Management System ...

Page 2: ...Blood sampling Testing Interpreting unexpected test results When to perform a control test Performing a control test Understanding out of range control test results Maintenance Replacing the battery Introduction Getting to know your system Setting up your meter Testing your blood glucose Memory and averages Control solution testing 01 02 03 06 06 07 08 09 09 10 10 11 14 15 17 17 20 22 25 28 30 30 ...

Page 3: ...nical information Specifications Disposing of the meter test strips lancets and batteries Warranty Symbol Index Traceability Performance Characteristics FCC Information 38 41 41 43 44 48 45 46 50 Caring for your system 36 ...

Page 4: ...rical current The meter measures electrical current and calculates amount of glucose The glucose result is displayed as a calculated plasma value Venous whole samples collection and preparation should be obtained by healthcare professionals The Sejoy BS 302 Test Strips are used with the Sejoy BG 210b Glucose Meters to quantitative measuring blood glucose with fresh capillary whole blood from the f...

Page 5: ...vice should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else to handle them Do not allow anyone else to test with the meter or lancing device 3 It is important to keep the meter and lancing device clean and disinfected Clean and disinfect the lancing device once per week to remove visible dirt or other material for safe...

Page 6: ...the meter and test strips are working properly DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT If your blood sugar result doesn t match how you feel and you have followed the instructions in this manual follow your doctor s instructions or call your doctor Children should be taught how to use the mete...

Page 7: ...results may be obtained at high altitude more than about 3 048 meters above sea level BS 302 blood glucose test strip less than 20 more than 70 of the hematocrit ratio will affect the measurement results Please contact your doctor to determine your hematocrit ratio Some substances may cause false results with enzymatic tests ...

Page 8: ...phen Bilirubin Creatinine Gentisic acid Haemoglobin Ibuprofen L Dopa Methyl DOPA Tolbutamide Triglycerides Xylose EDTA Substance Ascorbic acid Cholesterol Dopamine Glutathione Heparin Icodextrin Maltose Salicylate Tolazamide Uric acid Pralidoxime Iodide Galactose Concentration 20 mg dL 40 mg dL 10 mg dL 1000mg dL 20 g dL 50 mg dL 15 mg dL 1000 mg dL 8 mg dL 1500 mg dL 200 mg dL 200 mg dL Concentra...

Page 9: ...vice and Sterile Lancet EC REP Manufacturer of Lancing Device and Sterile LancetShandong Lianfa Medical Plastic Products Co Ltd No 1 Shuangshan Sanjian Road 250200 Zhangqiu City Jinan Shandong PEOPLE SREPUBLIC OF CHINA ShanghaiInternational Holding Corp GmbH Europe EC REPEiffestrasse 80 20537 Hamburg Germany Beijing Ruicheng Medical Suplies Co Ltd No 558 Zhangzikou Yangsong Town Huairou District 1...

Page 10: ...oth Display Measuring Unit Test Strip Reminder Apply Blood Sample Reminder Memory Test Result Alarm Clock Reminder Date And Time Average Voice Low Battery Reminder Temperature is range out of Hypoglycemia alarm High blood ketone alarm Ketone Ketone Hypo Hypo HCT Result Eject Button DOWN Button UP Button ...

Page 11: ...em operating temperature range Keep away from direct sunlight or heat Store your test strips in their original vial only never transfer them to another vial or any other container Never store individual test strips outside the vial After removing a test strip from the vial immediately close the vial cap tightly With clean dry hands you may touch the test strip anywhere when removing it from the vi...

Page 12: ...Getting to know your system d Lancet c Lancing Device Lancet Pin 9 Lancet Ejector Trigger Button Sliding Barrel Lancet Carrier Lancet Cap Lancing Device Arrow Adjustable Tip Lancet Cap ...

Page 13: ...to Forward or backward one day until the correct date appears Side up button or side down button After the date is set press button M the Hour figure is flashing automatically Set the hour Press and release the to Forward or backward one Side up button or side down button hour until the correct hour appears After the hour is set press button the Minute M figure is flashing automatically Set the mo...

Page 14: ...ring unit The meter can display test results in either milligrams per decilitre mg dL or millimoles per litre mmol L Press and hold Side up button or side down button for 5 seconds With the measuring unit preferred format on the display press button OR Set the time format to select the preferred format 11 Setting up your meter Press and release the to Forward or backward one Side up button or side...

Page 15: ...er low Blood glucose alarm concentration value setting in case Select OFF please press M key to enter High blood sugar alarm function setting Press and release the side up button or side down Key to move forward or backward one concentration Press until the correct concentration appears M key to enter high blood ketone alarm function Can be set Set low blood glucose alarm concentration value OR OR...

Page 16: ...M to enter high Blood ketone alarm concentration value setting in case Select OFF Please press M key to enter Voice mode setting OR OR Ketone Ketone OR Ketone mmol L Set high blood ketone alarm concentration value Press and release the side up button or side down Key to move forward or backward one concentration Press until the correct concentration appears M key to enter the voice mode setting 13...

Page 17: ...o confirm the alarm you selected press the side up button or the side down button to choose whether to turn on the alarm clock if it is on press the M button to switch to the alarm clock For time setting please refer to steps 3 and 4 for time setting After setting press M to enter the next alarm setting until all alarm settings are completed If the alarm is off skip the current alarm setting Final...

Page 18: ...e Settings menu on your smart phone or tablet 3 Create a new user login or login with your existing user name and password 4 Selection device Glucose Meter system Match your with a Smart Device 1 If this is your first time using it bind first Open SETTING menu choose Bind and unbind device and select the appropriate model The date and time on your Glucose Meter will automatically be updated when i...

Page 19: ... Bluetooth must be enabled 2 You can view your readings in the app blood glucose level GIU Login Thermometer Blood pressure monitor Glucose meter system After the measurement the systemautomaticall analyzes Figure 1 Figure 2 Figure 3 Figure 4 6 9 mmol L After the measurement the systemautomaticall analyzes After the measurement the systemautomaticall analyzes Figure 5 Figure 6 ...

Page 20: ...If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else to handle them Do not allow anyone else to test with the meter or lancing device It is important to keep the meter and lancing device clea...

Page 21: ...r and gently twist it until it separates from the lancet Replace the lancing device cap Avoid touching the lancet pin Adjust the depth setting The adjustable tip offers 5 levels of skin penetration Twist the lancing device cap until the desired setting appears Note To select the best depth 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin 18 ...

Page 22: ... lancing device cover in one hand Using the other hand slowly pull the sliding Barrel away from the lancing device cover You will hear a click indicating that the lancet carrier is locked into position Release sliding barrel to return it to its original position 19 ...

Page 23: ...drop If the blood smears or runs Do Not use that sample Wipe the area and gently squeeze another drop of blood or puncture a new site Approximate size against the side tip of the finger Press the trigger button and then lift the lancing device away from the finger after the puncture is complete Place the lancing device aside and wait a few seconds for a blood drop to form Position the end of the a...

Page 24: ...immediately after use to avoid contamination and damage Store unused test strips only in their original vial Do Not open the test strip vial until you are ready to remove a test strip and perform a test Use the test strip immediately after removing it from the vial Do Not return the used test strip to the vial after performing a test Do Not re use a test strip that had blood or control solution ap...

Page 25: ...strips with this meter can produce inaccurate results System check screen Note If appears it indicates the operating temperature is over range Place the system in operating temperature room for half hour Then test again If appears it indicates the battery is almost out of power Replace the battery now The blood drop symbol flashes on the display screen Your meter is now ready to apply blood sample...

Page 26: ...ill completely The blood drop will be drawn into the narrow channel and the confirmation window should fill completely When the confirmation window is full this means you have applied enough blood Now you can move the test strip away from the blood drop and wait for the meter to count down from 5 to 1with 1 beep sounds indicating the end of test Full Not full 23 After the measurement is over the m...

Page 27: ... the same time After memory cleared the mete will display dEL for aprrox 3 seconds and the nautomatically turn off up the side Turn your meter off Push the eject button gently to automatically eject the test strip from the meter or remove the test strip by hand the meter will automatically shut down Please handle the used test strip carefully ...

Page 28: ... Symptoms If you have a Lo reading and have symptoms such as weakness sweating nervousness headache or confusion then follow your doctor s recommendation to treat hypoglycemia Lo Reading without Symptoms If you get a Lo reading but have no symptoms of low blood glucose then retest with a new test strip on your fingers If you still get a Lo reading follow your doctor s recommendation to treat hypog...

Page 29: ...r blurry vision then follow your doctor s recommendation to treat hyperglycemia HI Reading without Symptoms If you get a HI reading but have no symptoms of high blood glucose then retest with a new test strip If you still get a HI reading follow your doctor s recommendation to treat hyperglycemia Unusual red blood cell count 26 BS 302 blood glucose test strip less then 20 more than 70 of the hemat...

Page 30: ...lution test to make sure the meter is working properly Do Not eat for at least eight hours before you test your blood glucose Take the meter to the lab While at the lab Conduct your meter test of the lab test within 15 minutes Use only fresh capillary blood obtained from the fingertip Follow all instructions in this Owner s Booklet to performing a blood glucose test by your meter will help you and...

Page 31: ...matically stores up to 1000 blood glucose test results with the time and date of the test and any test markers Results can at any time Test results are stored from the newest to the time and date correctly in the meter Having the correct time and date setting helps ensure appropriate interpretation of stored blood glucose results by you and your healthcare professional be reviewed t he oldest so s...

Page 32: ...ge This average includes all the readings from the last period days n indicates the number of results included in your average Deleting all memory Long Press the side down button approximately 3 seconds After memory cleared the meter will display dEL for aprrox 3 seconds and then automatically turns off mmol L 29 Long press the side up button for 3 second to enter the enter the average value query...

Page 33: ...re stored in extreme temperatures and or humidity Your test result does not match how you feel NOTE Only use the Sejoy CS 201 control solution Close the control solution bottle tightly after use Write the date you open the control solution bottle on the bottle label The control solution must be discarded 3 months from the first open date or the expire date on the vial label whichever comes first D...

Page 34: ... sample Shake the control solution vial before each test Remove the cap and squeeze the vial to discard the first drop Then wipe the tip with a clean tissue or cloth Hold the vial upside down and gently squeeze a hanging drop 31 The backlight will be lit every time the meter is turned on The screen will briefly display all content to confirm that the display is working properly Ketone Ketone Hypo ...

Page 35: ...ed to the flat face of the test strip Read the result on the meter When the confirmation window is full the meter will count down from 5 to 1 32 CONFIRMATION WINDOW TOP EDGE NARROW CHANNEL Apply Drop Here After the measurement is over the meter will voice broadcast the measurement result and display the blood glucose level along with the unit of measure the date and time of the test Blood glucose ...

Page 36: ...strip a problem with the meter CAUTION The control solution range printed on the test strip vial is for Sejoy Control Solution only It is not a recommended range for your blood glucose level CAUTION If you continue to get control solution test results that fall outside the range printed on the test strip vial Do Not use the meter the test strips or the control solution Contact Customer Service Con...

Page 37: ...ce Check your meter settings Replacing the battery does not affect your stored results However you may need to re set your meter settings See Setting Up Your Meter section 35 Your meter comes with 2xAAA batteries lithium battery The battery provides enough power for the meter to perform about 1000 tests If your battery runs low the battery symbol appears on every display screen until you change th...

Page 38: ...red the meter will display dEL about 3 seconds and then automatically turns off 34 Turn your meter off Push the eject button gently to automatically eject the test strip from the meter or remove the test strip by hand the meter will automatically shut down Please handle the used test strip carefully hold the side up button and side down button at the ...

Page 39: ...ginal vial Checking for expiration or damages to test strips and control solution Expiration dates for test strips and control solutions are printed on their vial labels When you first open a new vial of test strips or control solution record the discard date on the label Refer to the test strip or control solution vial for instructions on determining the discard date 20 55 4 131 Cleaning and disi...

Page 40: ...cing device until the surface is damp Be sure to squeeze out any excess liquid before you wipe the meter After wiping cover the surface you are disinfecting with the soft cloth dampened with the bleach solution for 1 minute Then wipe with a clean damp soft cloth and allow to air dry Wash hands thoroughly with soap and water after handling the meter and lancing device we recommend to disinfect peri...

Page 41: ...strip Remove the battery and reinsert it after 30 seconds If it still doesn t work please contact the vendor Retest with a new strip Make sure that the method of applying sample is correct and test strip can not be moved during testing Applying blood after the symbol flashes on the screen or sampling data is unstable 38 Retest with a new strip Make sure that the Strip model is correct and Retest w...

Page 42: ...Troubleshooting Battery power is low The meter is out of operating temperature range Replace the battery soon Place the system in appropriate operating environment for 30 minutes before retesting 39 ...

Page 43: ...p Defective meter or test strips Contact the vendor Blood or foreign objects put into the test strip port Test does not start after applying the blood sample Probable Cause What to Do Defective test strip Repeat the test with a new test strip Sample applied after meter times out and turns off Defective meter or test strips Troubleshooting meter and the top of the strip in the Remove the test strip...

Page 44: ...g System 0 5 33 3 mmol L 9 600 mg dL Fresh capillary whole blood Approximate 0 6 microlitre 5 seconds Approximately 1 000 tests mmol L or mg dL switchable 1000 blood glucose results with date and time Sample size Response time Battery Battery life Plasma equivalent glucose values Calibration 2xAAA batteries Glucose oxidase biosensor 94 9 56 5 22 8 mm L W H ...

Page 45: ...us low to other electrically driven equipment Interference from the meter is not anticipated was basic standard In addition it meets the electromagnetic IEC 60601 1 2 Weight Operating environment Meter storage environment Hematocrit 5 45 41 113 10 90 RH non condensing 20 55 4 131 Altitude Up to 10 000 feet 3 048 meters above sea level 10 95 RH non condensing LCD size 35 4 30 9 mm L H 20 70 Expecte...

Page 46: ...ealth department or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Please consider the following points when disposing of used testing materials Consider recycling of the meters and batteries at an appropriate facility Be aware the meter is potentially hazardous electronics scrap e scrap and should be disposed of accor...

Page 47: ...r from the date of purchase If the meter does not function properly due to defective components or poor workmanship we will repair or replace it freely This warranty does not cover damage due to improper handling in any way Battery does not included in the warranty 44 ...

Page 48: ...is referenced to the YSI glucose analyzer The YSI is the reference method used to assess the accuracy with which glucose results are obtained using the system The value of the calibrator for glucose is traceable to the National Institute of Standards and Technology NIST Standard Reference Material SRM 917b D Glucose Concentration 12 mmol L 45 ...

Page 49: ...tained using Glucose Analyzer a laboratory instrument Table1 System accuracy results for glucose concentration 5 55 mmol L YSI Table2 System accuracy results for glucose concentration 5 55mmol L generally should fall within 0 83mmol L 15 mg dL of the laboratory result If the blood glucose is below 5 5mmol L 100mg dL the results the results generally should fall within 15 of the laboratory result I...

Page 50: ...lab While at the lab Conduct your meter test within 15 minutes of the lab test Use only fresh capillary blood obtained from the fingertip Follow all instructions in this Owners Booklet for performing a blood glucose test with your meter Performance Characteristics 47 Control Solutionav 2 43 mmol L CV 5 5 Control Solutionav 7 51 mmol L CV 3 3 Control Solutionav 20 73 mmol L CV 2 6 Blood av 2 42 mmo...

Page 51: ...s for use In vitro diagnostic medical device Serial number Batch code Manufacturer Contain sufficient for n tests Caution Do not reuse Use by Storage temperature limitation Sterilized using irradiation STERILE R Storage limitation humidity ...

Page 52: ...o the requirements of the EC Directive IVDD 98 97 EC on in vitro diagnostic medical devices XXXX is the identification number of notify body Biological risks Keep dry Direct Current Please dispose of the waste according to the local regulations ...

Page 53: ...s 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 radiofrequency energy If this equipment does cause harmful interference to radio or television reception which can be de...

Page 54: ...ttp wayback archive it org 7993 20170111013014 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 https www cdc gov injectionsafety Fingerstick DevicesBGM htmlfor Disinfection and Sterilization in Healthcare Facilities Atlanta ...

Page 55: ...ersion Z Date of Issue DBG 1404 019 20XX XX Hangzhou Sejoy Electronics Instruments Co Ltd Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone HangZhou City 311100 ZheJiang China Tel 86 571 81957767 ...

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