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Sejoy BG-207b, Owner'S Booklet

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Appendix

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

    Transmitting Bloodborne 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 Bloodborne 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."

 49

Summary of Contents for BG-207b

Page 1: ...Owner s Booklet BG 207b 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 12 13 15 15 18 20 23 26 28 28 ...

Page 3: ...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 Appendix 49 ...

Page 4: ...nal in a clinical setting as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis Test Principle 1 Peel off the insulation film from battery compartment before first use The strip measures glucose by using amperometric technology employing a glucose oxidaes reaction When whole blood or con trol solution is drawn into the tip of a test strip glucose in the...

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 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...

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: ...sults may be obtained at high altitude more than about 3 048 meters above sea level 4 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: ...d 55 56 mmol L 1000 mg dL Hemoglobin 27 78 mol L 500 mg dL Ibuprofen 2 78 mmol L 50 mg dL L Dopa 0 03 mmol L 0 5 mg dL Methyldopa 55 56 mmol L 1000 mg dL Tolbutamide 5 55 mmol L 100 mg dL Triglycerides 83 33 mmol L 1500 mg dL Xylose 11 11 mmol L 200 mg dL EDTA 11 11 mmol L 200 mg dL Substance Concentration Ascorbic acid 0 17 mmol L 3 mg dL Cholesterol 27 78 mmol L 500 mg dL Dopamine 0 11 mmol L 2 ...

Page 9: ...evice d Sterile Lancet e Control Solution INCLUDED WITH YOUR KIT WARNING Keep the meter and testing supplies away from young children Small items such as the battery cover batteries test strips lancets protective covers on the lancets and control solution vial cap are choking hazards e 6 ...

Page 10: ... Strip Reminder Apply Blood Sample Reminder Memory Over Operating Temperature Low Battery Reminder Test Result Alarm Clock Reminder Date And Time Average 7 Strip Port LCD M Button S Button Battery Compartment Battery Cover Alarm Clock Reminder HCT Result Bluetooth ...

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

Page 13: ...ically 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 button S the Minute figure is flashing automatically 10 Set the month Press and release the butto...

Page 14: ...nd 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 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 the display press button mg dL mmol L O...

Page 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 ...

Page 16: ...uld enable Bluetooth on your device You can enable Bluetooth under the Settings menu on your smart phone or table 3 Create a new user login or login with your existing user name and password 4 Selection device Glucose meter system Pairing your monitor with a Smart Device 1 Open the Glucose meter system and follow the pairing instructions shown on your smart phone The date and time on your monitor ...

Page 17: ...Bluetooth connection 14 Transfer your readings 1 As soon as your measurement is complete open the app on your smart phone to transfer your reedings 2 You can view your blood sugar readings on the APP ...

Page 18: ...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...

Page 19: ...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 16 ...

Page 20: ... 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 17 ...

Page 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 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 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 ap...

Page 23: ...test strips Using other test strips with this meter can produce inaccurate results System check screen Each time the meter powers on this screen briefly appears so that you can make sure the display is working properly 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...

Page 24: ...he 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 have applied en...

Page 25: ...keep the test result press S Turn your meter off Simply remove the test strip Carefully dispose the used test strip 22 button and M button to delete it at the same time After memory cleared the mete will display dEL for aprrox 3 minutes and the nautomatically turn off ...

Page 26: ... your test results are lower or higher than what you expect Low glucose results If your test result is lower than 0 5mmol L 9mg 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 recommendat...

Page 27: ...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 24 BS 302 blood glucose test strip less than 20 more than 70 of the hemat...

Page 28: ...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 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...

Page 30: ...ward to averages 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 aprrox 3 minutes and then automatically turns off mmol L 27 ...

Page 31: ...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 32: ... 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 29 ...

Page 33: ...ely Control solution 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 blood glucose level appears on the display along with the unit of measure the date and time of the test The results are automatically stored in the meter s memory CONFIRMATION WINDOW TOP EDGE NARROW CHANNEL Apply Drop ...

Page 34: ...ntaminated control solution expired or damaged test strip use of a test strip or control solution 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 prin...

Page 35: ...eep the test result press the S and M button to delete it at the same time After memory cleared the meter will display dEL about 3 minutes and then automatically turns off To turn your meter off simply remove the test strip Carefully dispose of the used test strip 32 ...

Page 36: ...he 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 meter settings See Setting Up Your...

Page 37: ...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 38: ...to disinfecting To disinfect prepare a solution of 1 part household bleach and 9 parts water Hold the meter with the strip port and pointed down Use a soft cloth dampened with this solution to wipe the outside of the meter and 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...

Page 39: ...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 36 Retest with a new strip Make sure that the Strip model is correct and Retest w...

Page 40: ...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 37 ...

Page 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...

Page 42: ...se oxidase biosensor 0 5 33 3 mmol L 9 600 mg dL Fresh capillary whole blood Approximate 0 6 microlitre 5 seconds 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 90 61 18 1 mm L W H Sample size Response time Battery Battery life Plasma equivalent glucose values Calibration 39 ...

Page 43: ...x 3 minutes after last user action 10 80 RH non condensing LCD size 35 4 30 9 mm L H 40 Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements as standard ISO 15197 immunity testing The chosen basis for electrostatic discharge emissions EN 61326 Its electromagnetic emission requirements as standrard is thus low to other electrically driven equipment Interference f...

Page 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...

Page 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 ...

Page 46: ...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 L0 25mmol L diluted 51 fold ready for use ...

Page 47: ...obtained using Glucose Analyzer a laboratory instrument Table1 System accuracy results for glucose concentration 5 5 mmol L YSI Table2 System accuracy results for glucose concentration 5 5mmol 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 48: ...ontrol 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 only fresh capillary blood obtained from the fingertip Follow all instructions in this Owners Booklet for performing a blood glucose test with your meter ...

Page 49: ...ructions for use In vitro diagnostic medical device Serial number Batch code Contain sufficient for n tests Caution Do not reuse Use by STERILE EO Sterilized using ethylene oxide Storage temperature limitation 46 Biological risks ...

Page 50: ...Symbol Index Keep dry This symbol indicates that you should not discard waste electrical or electronic equipment WEEE in the trash For proper disposal contactyour local Direct Current 47 ...

Page 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...

Page 52: ...Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne 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 Ste...

Page 53: ... DBG 1204 044 Version Z Date of Issue 20XX XX Manufactured by Hangzhou Sejoy Electronics Instruments Co Ltd Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone HangZhou City 311100 ZheJiang China ...

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