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Sejoy BG-203, Owner'S Booklet

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Sejoy BG-203 Owner'S Booklet Download Page 48

Symbol Index

xxxx

The produ

ct conforms to the requirements of the EC

 

Directive IVDD ( 98/79/EC ) on in vitro diagnostic medical  

devices

 “xxxx" is the identification number of notify body

Keep dry

Direct Current

 

45

European Authorized Representative

EC

REP

Please dispose of the waste according to the
local regulations

Summary of Contents for BG-203

Page 1: ...Owner s Booklet BG 203 Blood Glucose Monitoring System Advanced Diabetes Management System mmol L AM ...

Page 2: ... to perform a control test Performing a control test Understanding out of range control test results Maintenance Replacing the battery Meter maintenance Introduction Getting to know your system Setting up your meter Testing your blood glucose Memory and averages Control solution testing 01 02 06 06 07 08 09 09 10 10 11 12 13 13 16 18 21 24 26 26 27 29 31 31 32 Comparing Your Meter Result to a Labo...

Page 3: ...ubleshooting Technical information Specifications Disposing of the meter test strips lancets and batteries Warranty Traceability 34 37 37 39 40 41 Performance Characteristics 42 Symbol Index 44 Appendix 46 ...

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 102 Test Strips are used with the Sejoy BG 203 Blood Glucose Meter to quantitative measure blood glucose with fresh capillary whole blood or venou...

Page 5: ...e should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else handle them Do not allow anyone else to test with the meter or lancing device For instructions on how to clean and disinfect the meter and lancing device see Chapter Maintenance Wash hands thoroughly before and after handling the meter lancing device or test stri...

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 glucose 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 m...

Page 7: ... new born Inaccurate test results may be obtained at high altitude more than about 3048 meters above sea level BS 102 blood glucose test strip less than 30 or more than 55 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: ...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 EN ISO 15197 2015 Annex A are not verified it may also affect the test results ...

Page 9: ...ened 2 0ml S 32 mmol L AM a In door glucose measurement is recommended Manufacturer of Lancing Device 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 G...

Page 10: ...Button M Button Apply Blood Sample Reminder Memory Low Battery Reminder Average AVG mg dL mmol L MEM Measuring Unit AM PM Alarm Clock Reminder Time Month Date Test Result Temperature is out of range Display 7 Battery Compartment Battery Cover Eject button ...

Page 11: ...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 vial ...

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

Page 13: ...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 date appears After the date is set press button S the hour figure is flashing automatically advance one day until the correct Set the hour Press and release the button M to hour appears After the hour is set press button S the minute figure is flashing automa...

Page 14: ... the format With the preferred time format on the display press button S the measuring unit figure will appear OR OR Set the time format advance one minute until the mg dL mmol L 11 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 format With the preferred measuring unit format on t...

Page 15: ...e testing time Press button M to check the alarm function If the alarm is on press button S the time figure is flashing For time setting refer to step 3 and 4 After setting press button S to exit the setting mode If there is no alarm function requirement press the S key to exit the setting mode 12 ...

Page 16: ...f 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 clean...

Page 17: ... lancet needle cover and gently twist it off the lancet Put on the lancing device cap Avoid touching the trigger button Adjust the depth setting The indication marks 5 levels of skin penetration Switch the lancing device cap to the desired setting Note To select the best depth 1 2 for soft or thin skin 3 for average skin 4 5 for thick or calloused skin ...

Page 18: ... 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 15 ...

Page 19: ...ss the trigger button and then lift the lancing device Gently squeeze your finger until you get a round drop of blood Discard the first drop Do not use If the blood is smeared or running Wipe the area and gently squeeze another drop of blood or puncture a new site Approximate size away from the finger after the puncture is complete Place the lancing device aside and wait a few seconds for a blood ...

Page 20: ...ter 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 applied to it Te...

Page 21: ...y to apply blood sample the display screen Your meter is now Note If you do not start the test within unused test strip and reinsert it into Important The meter should only be test strips with this meter can produce inaccurate results three minutes the meter will turn off To restart your meter take out the the meter used with BS 102 test strips Using other With meter off or in setting mode and mem...

Page 22: ...a test Wait for the confirmation 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 Full Not full mmol L 19 Discard the first drop of blood Do Not smear or scrape the drop o...

Page 23: ... 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 press the S button and M button at the same time to delete it After memory cleared the meter will display dEL and then turn off automatically ...

Page 24: ...ct Low glucose results If your test result is lower than 2 2 mmol L 40 mg dL Lo will appear on the meter display screen This reading indicates severe hypoglycemia low blood glucose Lo Reading with 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 ...

Page 25: ...rst excess 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 Unusual hematocrit Too high above 55 or too low below 30 hematocrit can cause in...

Page 26: ...rm a control solution test to make sure the meter is working properly Do Not eat for at least eight hours before you test your blood glucose While at the lab Perform your meter test within 15 minutes from the lab test Use only fresh capillary blood obtained from the fingertip Follow all instructions in this Owner s Booklet to perform a blood glucose test by your meter will help you and your health...

Page 27: ...t 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 be reviewed at any time Test results are stored from the newest to the oldest so set the time and date correctly in the meter Setting the correct time and...

Page 28: ...he average value display 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 Delete all memory seconds After memory cleared the meter will display dEL and then turn off automatically 25 mmol L AVG MEM Long press the S button approximately 3 ...

Page 29: ...e 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 after the first open date or the expire date on the vial label whichever comes first D...

Page 30: ...ay screen Your meter is now ready to Shake the control solution vial before 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 briefly appears so that you can make sure apply blood sample each test Remove the cap and squeeze the drop AVG mg dL mmol L MEM AM PM AVG mg dL mmol L MEM AM PM AVG mg dL mmol L MEM AM PM AVG...

Page 31: ...should not be applied to the flat face of the test strip CONFIRMATION WINDOW Read the result on the meter 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 time of the test Results are automatically stored in the meter s memory TOP EDGE NARROW CHANNEL Apply Drop Here mmol L mmol L 28 along with th...

Page 32: ...expired or damaged test strip use of a test strip or control solution that passed its discard date 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 v...

Page 33: ...will display dEL and then turn off automatically the S and M button to at the same time to delete mmol L AVG MEM 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 34: ...rs you should replace the battery immediately With the meter off 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 meter settings See Setting up your...

Page 35: ...king 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 32 20 55 4 131 Cleaning and disinfection Cle...

Page 36: ... your meter and lancing device prior to disinfecting To disinfect prepare a solution of 1 part household bleach and 9 parts water Hold the meter with the strip port down Use a soft cloth damped with this solution to wipe the outside of the meter and lancing device Be sure to squeeze out any excess liquid first After wiping cover the surface you are disinfecting with the soft cloth damped with the ...

Page 37: ...trip 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 34 Make sure that the strip model is correct and retest with a new strip Make sure...

Page 38: ...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 35 ...

Page 39: ...rted into the meter Check that the test strip is inserted correctly 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 Troublhes...

Page 40: ... 2 2 33 3mmol L 40 600mg dL Fresh capillary whole blood Approximate 1 microlitre 5 seconds No coding One 3 0V CR2032 button battery replaceable Approximately 1 000 tests mmol L or mg dL switchable 360 blood glucose results with date and time 109 29 7 18 9mm L W H Sample size Response time Coding Battery Battery life 37 Calibration Plasma equivalent glucose values Shelf life Three years ...

Page 41: ... after last user action 38 10 70 RH non condensing 43 7 17 6mm L H LCD size Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as standard EN ISO 15197 2015 The chosen basis for electrostatic discharge immunity testing was basic standard EN 61326 2013 It meets the electromagnetic emissions requirements as standard EN 61326 Its electromagnetic emission is thus ...

Page 42: ...rtment 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 that the meter is potentially hazardous electronics scrap e scrap and should be disposed of accordingl...

Page 43: ...ar 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 is not included in the warranty 40 ...

Page 44: ...c 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 glucose is traceable to the National Institute of Standards and Technology NIST Standard Reference Material SRM 917c D Glucose Concentration 200 mg dL ...

Page 45: ... results for glucose concentration 5 55 mmol L 100 mg dL Table2 System accuracy results for glucose concentration 5 55mmol L 100 mg dL When the blood glucose is below 5 55mmol L 100 mg dL 99 4 of measured glucose results should fall within 0 83mmol L 15 mg dL of the laboratory result When the blood glucose is equal to or above 5 55mmol L 100 mg dL 100 of measured glucose results should fall within...

Page 46: ...instructions in this Owners Booklet for performing a blood glucose test with your meter Blood av 4 1mmol L CV 4 9 Blood av 6 7mmol L CV 3 0 Blood av 10 3mmol L CV 3 1 Blood av 18 2mmol L CV 3 0 Precision Control Solution av 2 6mmol L SD 0 16mmol L Intermediate Precision Control Solution av 18 9mmol L CV 3 8 Blood av 2 5mmol L SD 0 14mmol L Repeatability Table3 System accuracy results for glucose b...

Page 47: ...tructions for use In vitro diagnostic medical device Serial number Batch code Manufacturer Sterilized using ethylene oxide Contain sufficient for n tests Caution Do not reuse Storage temperature limitation Use by 2 44 STERILE EO ...

Page 48: ...nts of the EC Directive IVDD 98 79 EC on in vitro diagnostic medical devices xxxx is the identification number of notify body Keep dry Direct Current 45 European Authorized Representative EC REP Please dispose of the waste according to the local regulations ...

Page 49: ...Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood borne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Accessed June 8 2011 3 Healthcare Infection Control Pratices Advisory Committee HICPAC William A Rutala Ph D M P H and David J Weber M D M P H Centers for Disease Control and Prevention 2008 Guideline for Disinfection and St...

Page 50: ...uilding 2 No 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang P R China EC REP Document No DBG 0304 007 Version F Date of Issue 2022 03 Shanghai International Holding Corp Gmbh Europe Eiffestrasse 80 20537 Hamburg Germany 0197 ...

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