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Appendix

1. Use of Fingerstick Devices on More Than One Person Poses Risk for

Transmittin

g Blood-borne Pathogens: Initial Communication, (2010)

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.

Accessed June 8, 2011

2. CDC Clinical 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

Sterilization in Healthcare Facilities, Atlanta."

Содержание BG-201

Страница 1: ...Owner s Booklet BG 201 Blood Glucose Monitoring System Advanced Diabetes Management System ...

Страница 2: ...rpreting unexpected test results Comparing Your Meter Result to a Laboratory Result When 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 03 06 06 07 08 09 ...

Страница 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 ...

Страница 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 201 Blood Glucose Meter to quantitative measure blood glucose with fresh capillary whole blood or venou...

Страница 5: ...ice 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 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 han...

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 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...

Страница 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 ...

Страница 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 2015AnnexAare not verified it may also affect the test results ...

Страница 9: ...tional Holding Corp GmbH Europe EC REPEiffestrasse 80 20537 Hamburg Germany Beijing Ruicheng Medical Suplies Co Ltd No 558 Zhangzikou Yangsong Town Huairou District 10400 Bejing China Lotus NL B V EC REPKoningin Julinaplein 10 le Verd 2595AA The Hague Netherlands CE 0123 for sterile lancet CE for lancing device CE 0197 for sterile lancet CE for lancing device EC REP f WARNING Keep the meter and te...

Страница 10: ... BLOOD GLUCOSE METER SN 0197 EC REP MADE IN CHINA For In vitro Diagnostic Use only Th e me te r is in te nd ed to be us ed fo r th e qu an ti ta ti ve me as ur em en t of gl uc os e in ca pi ll ar y wh ol e bl oo d 40 10 Battery Compartment Battery Cover S M AVG OK mg dL mmol L MEM M D AM PM Getting to know your system a Meter Display Strip Port LCD M Button S Button Measuring Unit Test Strip Remi...

Страница 11: ...m 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 via...

Страница 12: ...Getting to know your system 9 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 ...

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: ...n S to enter the alarm clock setting mg dL mmol L OR 11 Set the minute Press and release the button M to advance one minute until the correct minute appears After the minute is set press button S the time format figure will appear The meter can display the time in either an AM PM 12 hour or a 24 00 24 hour format Press and release button M to select the format With the preferred time format on the...

Страница 15: ... the 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 ...

Страница 16: ...ns 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 c...

Страница 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 ...

Страница 18: ...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 19: ... 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 against the side 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...

Страница 20: ...y 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 applied to i...

Страница 21: ... should only be used with BS 102 test strips Using other test strips with this meter can produce inaccurate results System check screen The screen will briefly display all content to confirm that the display is working properly Note If appears it indicates that the operating temperature is out of range Place the system in room temperature for half hour Then test again If appears it indicates that ...

Страница 22: ...ar or scrape the drop of blood with the test strip Do Not apply more blood to the test strip after you have moved the drop of blood away Do Not move the test strip in the meter during 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 h...

Страница 23: ...e test result press the S Turn your meter off button and M button at the same time to delete it After memory cleared the meter will display dEL and then turn off automatically Remove the test strip by hand the meter will automatically shut down Please handle the used test strip carefully ...

Страница 24: ...e 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 If you get a Lo reading but have no symptoms of low blood glucose then retest with a new test str...

Страница 25: ...thirst 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...

Страница 26: ...ory test results both are expressed in plasma equivalent units However your blood glucose meter result may differ from your laboratory result due to normal variation Your blood glucose meter results can be affected by factors and conditions that do not affect laboratory results in the same way To maximize your chances of an accurate comparison between meter and laboratory results please follow a f...

Страница 27: ...sult will display first 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 Settin...

Страница 28: ...enter the 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 Press and hold S button approximately 3 seconds After memory cleared the meter will display dEL and then turn off automatically mmol L ...

Страница 29: ...were 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 firs...

Страница 30: ...briefly appears so that you can make sure the display is working properly The blood drop symbol flashes on the display screen Your meter is now ready to apply blood 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 S M ...

Страница 31: ...lution should not be applied 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 After the measurement is over the meter will display the blood glucose level along with the unit of measurement the date and time of the test Results are automatically stored in the meter s memory CONFIRMATION WINDOW TOP EDGE NARROW...

Страница 32: ... the instructions detailed in steps 1 6 expired or contaminated control solution 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 cont...

Страница 33: ... the test result press the S and M button at the same time to delete it After memory cleared the meter will display dEL and then turn off automatically Turn your meter off Remove the test strip by hand the meter will automatically shut down Please handle the used test strip carefully ...

Страница 34: ... this symbol appears you should replace the battery immediately With the meter off open the battery cover 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 se...

Страница 35: ...ir 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 an...

Страница 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 ...

Страница 37: ... 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 Make sure that the strip model is correct and retest w...

Страница 38: ...Troubleshooting 35 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 39: ...r incompletely inserted 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 te...

Страница 40: ...mol L 40 600 mg dL Fresh capillary whole blood or venous 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 80 5 55 16 3mm L W H Sample size Response time Coding Battery Battery life 37 Calibration Plasma equivalent glucose values Shelf life Three years...

Страница 41: ...ter last user action 37 36 39 37 38 10 70 RH non condensing LCD size 28 1 26mm L H 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 i...

Страница 42: ...partment 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 accordin...

Страница 43: ... year 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 ...

Страница 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 ...

Страница 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 100 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 1...

Страница 46: ...m 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 Take your meter with you to the lab While at the lab Conduct your meter test within 15 minutes of the lab test Use fresh capillary blood obtained from the fingertip Follow all instructions in this Owners Booklet for performing a blood glucose test with your meter This...

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

Страница 48: ...nts of the EC Directive IVDD 98 97 EC on in vitro diagnostic medical devices xxxx is the identification number of notify body Keep dry Please dispose of the waste according to the local regulations Direct Current 45 European Authorized Representative EC REP ...

Страница 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...

Страница 50: ...03 Hangzhou Sejoy Electronics Instruments Co Ltd Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang P R China EC REP Shanghai International Holding Corp Gmbh Europe Eiffestrasse 80 20537 Hamburg Germany 0197 ...

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