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Traceability

43

The calibrator of the Sejoy Blood Glucose Monitoring System
BG-211b is control solution. The traceability of the control solution
is referenced to the EKF BIOSEN C line-Clinic glucose analyzer.
The EKF 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

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Содержание BG-211b

Страница 1: ...Owner s Booklet BG 211b Blood Glucose Monitoring System Advanced Diabetes Management System ...

Страница 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 12 13 15 15 18 20 23 26 28 28 ...

Страница 3: ...nical information Specifications Disposing of the meter test strips lancets and batteries Warranty Symbol Index Traceability Performance Characteristics FCC Information 36 39 39 41 42 46 43 44 48 Caring for your system 34 ...

Страница 4: ... care professional in a clinical setting as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis of diabetes or for testing newborns Test Principle Glucose in the blood sample mixes with special chemicals in the test strip and a small electric current is produced The strength of this current changes with the amount of the glucose in the blood sample The m...

Страница 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 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 3 other material for safe...

Страница 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...

Страница 7: ...est on neonatal samples new born Inaccurate test results may be obtained at high altitude more than about 3 048 meters above sea level Hematocrit range 30 to 55 Hematocrit below 30 may cause higher results and hematocrit above 55 may cause lower results Some substances may cause false results with enzymatic tests 4 ...

Страница 8: ... or higher therapy levels Acetaminophen Ascorbic acid Ibuprofen 2 0 mg dL 2 0 mg dL 4 2 mg dL Levodopa Creatinine Dopamine No clear range of effective drug concentration 1 5 mg dL 0 04 mg dL Tetracycline 0 5 mg dL Urate 8 0 mg dL Other interfering substances in ISO 15197 Annex A are not verified it may also affect the test results ...

Страница 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...

Страница 10: ...ip Port LCD M Button S Button mmol L Eject Button Bluetooth AVG OK mg dL mmol L MEM M D AM PM Display Measuring Unit Test Strip Reminder Apply Blood Sample Reminder Memory Test Result Month Date Alarm Clock Reminder Time Average Low Battery Reminder Temperature is out of range ...

Страница 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...

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

Страница 13: ...rrect month appears After the month is set press button S the Date figure is flashing automatically Set the date Press and release the button M to advance one day until the correct date appears After the date is set press button S the Hour figure is flashing automatically Set the hour Press and release the button M to advance one hour until the correct hour appears After the hour is set press butt...

Страница 14: ...s and release button M to select the format With the preferred time format on the display press button S the measuring unit figure will appear OR mg dL mmol L OR Set the time format Set the measuring unit The meter can display test results in either milligrams per decilitre mg dL or millimoles per litre mmol L Press and hold button S and M for 5 seconds With the measuring unit preferred format on ...

Страница 15: ...ng Press button M to check the alarm function If the alarm is on press button S the time figure is flashing Please refer to step 3 and 4 for the time setting After the time is set press button S button to exit the setting mode If there is no alarm function requirement press button S to exit the setting mode 12 ...

Страница 16: ...s 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 cl...

Страница 17: ...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...

Страница 18: ... 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 ...

Страница 19: ...over 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 ...

Страница 20: ...the 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 ...

Страница 21: ...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 18 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 th...

Страница 22: ... 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 a...

Страница 23: ...s 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 20 A...

Страница 24: ...mation window to fill 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 mmol L 21 After the ...

Страница 25: ... will display dEL for aprrox 3 seconds and the nautomatically turn off 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 Testing your blood glucose 22 Delete the memory ...

Страница 26: ...th 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 mmol L reading follow your doctor s recommendation to tr...

Страница 27: ...cess urination or 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 24 Unusual red blood cell count A hematocrit percentage of your blood that is red bloo...

Страница 28: ...solution 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 a...

Страница 29: ...Note If there is no test result stored the meter will display for a few seconds then automatically turn off The meter automatically stores up to 360 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 approp...

Страница 30: ...ages The first memory display screen you see is your 7 day average This average includes all the readings from the last period days n indicates the number of results included in your average Deleting all memory Press and hold S button approximately 3 seconds After memory cleared the meter will display dEL for with 3 beep sounds for aprrox 3 seconds and then automatically turns off mmol L 27 ...

Страница 31: ...re stored in extreme temperatures and or humidity Your test result does not match how you feel NOTE Only use the Sejoy CS 101 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...

Страница 32: ...le 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 29 AVG OK mg dL mmol L MEM M D AM PM 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...

Страница 33: ...hould not be applied to the flat face of the test strip Read the result on the meter CONFIRMATION WINDOW TOP EDGE NARROW CHANNEL Apply Drop Here mmol L 30 When the confirmation window is full the meter will count down from 5 to 1 After the measurement is over the meter will display the blood glucose level along with the unit of measure the date and time of the test Blood glucose results are automa...

Страница 34: ...1 6 expired or contaminated control solution expired or damaged test strip use of a test strip or control solution passed its discard date that 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 ...

Страница 35: ... at the same time memory cleared the meter will display dEL about 3 seconds and then automatically turns off 32 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 ...

Страница 36: ...bol appears you should replace the battery immediately With the meter off open the battery cover side facing up Remove the old batteries and place the new ones in the battery compartment with the side facing up Put the battery cover back into position until it locks into place Check your meter settings Replacing the battery does not affect your stored results However you may need to re set your me...

Страница 37: ...original 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 d...

Страница 38: ...lancing 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 p...

Страница 39: ...ay be moved during testing The strip check has problem Repeat with a new 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 Retest w...

Страница 40: ...Troubleshooting 37 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 ...

Страница 41: ... inserted into the meter Insert the test strip with the printed side up 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 Troub...

Страница 42: ...33 3 mmol L 40 600 mg dL Fresh capillary whole blood Approximate 1 microlitre 5 seconds No coding One 3 0V CR2032 lithium battery replaceable Approximately 1 000 tests mmol L or mg dL switchable 360 blood glucose results with date and time Sample size Response time Coding Battery Battery life 39 Calibration Plasma equivalent glucose values Size 90 62 2 19 6 mm L W H LCD size 36 31 mm L H ...

Страница 43: ...Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as standard IEC 60601 1 2 The chosen basis for electrostatic discharge immunity testing emissions Its electromagnetic emission requirements as standrard IEC 60601 1 2 is thus low to other electrically driven equipment Interference from the meter is not anticipated was basic standard In addition it meets the el...

Страница 44: ...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...

Страница 45: ...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 42 ...

Страница 46: ...enced to the EKF BIOSEN C line Clinic glucose analyzer The EKF 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 ...

Страница 47: ...tained using EKF Glucose Analyzer a laboratory instrument Table1 System accuracy results for glucose concentration 5 55 mmol L Table2 System accuracy results for glucose concentration 5 55mmol L Within 0 28 mmol L Within 0 56 mmol L Within 0 83 mmol L Percentage Within 10 Within 15 Within 20 generally should fall within 0 83mmol L 15 mg dL of the laboratory result If the blood glucose is below 5 5...

Страница 48: ...ur 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 45 Precision Intermediate Precision Repeatability Control Solutionav 2 41 mmol L CV 5 2 Control Solutionav 7 51 mmol L CV 3 3 Control Solutionav 20 73 mmol L CV 2 6 B...

Страница 49: ...instructions for use In vitro diagnostic medical device Serial number Batch code Manufacturer Contain sufficient for n tests Caution Do not reuse Use by 46 Sterilized using irradiation Storage temperature limitation STERILE R ...

Страница 50: ...he 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 47 Please dispose of the waste according to the local regulations ...

Страница 51: ...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...

Страница 52: ... 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 49 ...

Страница 53: ...y Electronics Instruments Co Ltd Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang China Document No Version Z Date of Issue DBG 1504 011 20XX XX Tel 86 571 81957767 ...

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