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Appendix

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

Transmitting

Blood-borne Pathogens: Initial Co

mmunication, (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 Tran

smitting

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-709

Страница 1: ...Owner s Booklet BG 709 Blood Glucose Monitoring System Advanced Diabetes Management System ...

Страница 2: ...esting 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 13 16 18 21 24 26 26 27 29 31 31 Compari...

Страница 3: ...g Technical information Specifications Disposing of the meter test strips lancets and batteries Warranty Symbol Index Traceability Performance Characteristics 34 37 37 39 40 44 41 42 Meter maintenance 32 Appendix 46 ...

Страница 4: ...e effectiveness of diabetes control This system is not for use in the diagnosis of diabetes mellitus 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 dehydrogenase reactio When whole blood or n control solution is drawn into the tip of a test strip glucose in the sample reacts wit...

Страница 5: ...ce 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 other material for safe handli...

Страница 6: ...the meter and test strips are working properly DO NOT CHANGE YOUR TREATMENT BASED ONASINGLE 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 mete...

Страница 7: ...ccurate test results may be obtained at high altitude more than about 3048 meters above sea level BS 602 blood glucose test strip 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 ...

Страница 8: ...mmol L 1094 4mg dL L Dopa 0 03mmol L 0 5mg dL Maltose 555 56mmol L 1 0000mg dL Methyl DOPA 0 22mmol L 4mg dL Salicylate 3 33mmol L 60mg dL Tolbutamide 5 55mmol L 100mg dL Tolazamide 0 56mmol L 10mg dL Triglycerides 83 33mmol L 1500mg dL Uric acid 1 33mmol L 24mg dL Xylose 2 78mmol L 50mg dL Pralidoxime Iodide 0 83mmol L 15mg dL EDTA 11 11mmol L 200mg dL Galactose 0 83mmol L 15mg dL The interferenc...

Страница 9: ...urer 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 Germany Beijing Ruicheng Medical Suplies Co Ltd No 558 Zhangzikou Yangsong Town ...

Страница 10: ...on Battery Compartment Battery Cover Eject Button Display Measuring Unit Test Strip Reminder Apply Blood Sample Reminder Memory Test Result Alarm Clock Reminder Date And Time Average Alarm Clock Reminder HCT Result Voice Low Battery Reminder Temperature is range out of ...

Страница 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...

Страница 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 ...

Страница 13: ...lly 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 button M...

Страница 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 preferred measuring unit format on the display press button mg dL mmol L O...

Страница 15: ...n 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 OR Set voice mode Press and release button M to select the voice mode press button S to enter the alarm clock setting ...

Страница 16: ...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...

Страница 17: ...ncet 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 14 ...

Страница 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 ...

Страница 19: ...e 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 ad...

Страница 20: ...fter 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 T...

Страница 21: ...ed with BS 602 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 the battery is alm...

Страница 22: ...rip 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 enough blood Now you can move the t...

Страница 23: ...tton and M button at the same time to delete it After memory cleared the meter will display dEL and then turn off automatically 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 24: ...rvousness 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 hypoglycemia Before breakfast Before lunch or supper 1 hour after meal 2 hour after me...

Страница 25: ...s fatigue 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 22 Too high above 70 hematocrit can cause inaccu...

Страница 26: ... 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 fresh capillary blood obtained from the fingertip venous blood neonatal blood Follow all instructions in this Owner s Booklet to perform a blood glucose test by your meter will help you and ...

Страница 27: ...t 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 Setting t...

Страница 28: ...er 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 Long press the S button approximately 3 seconds After memory cleared the meter will display dEL and then turn off automatically mmol L 25 ...

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

Страница 30: ... 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 27 ...

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 along with the unit of measurement the date and time of the test Results are automatically stored in the meter s memory 28 CONFIRMATION WINDOW TOP EDGE NARROW CHANNEL Apply Drop Here over the meter will disp...

Страница 32: ...d 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 vial Do...

Страница 33: ...me time to delete it After memory cleared the meter will display dEL and then turn off automatically Turn your meter off 30 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 34: ...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 31 Your meter comes with two AAA batteries alkaline battery The battery provides enough power for the meter to perform about 1000 tests If your battery runs low the battery symbol appears on display screen until you change the batt...

Страница 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 20 55 4 131 Cleaning and disinfection Cleani...

Страница 36: ...ur 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 ble...

Страница 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 retest with a new strip Make sure that the strip model is correct and retest wi...

Страница 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 ...

Страница 39: ...or 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 Check that the test strip is inserted correctly Remove the test strip and repeat the test using test strip s...

Страница 40: ...mol L 9 600mg dL Fresh capillary whole blood venous blood neonatal blood Approximate 0 6 microlitre 5 seconds Approximately 1 000 tests mmol L or mg dL switchable 360 blood glucose results with date and time Sample size Response time Battery Battery life Plasma equivalent glucose values Calibration 2xAAA alkaline batteries 90 61 23 6mm L W H Glucose dehydrogenase biosensor ...

Страница 41: ... thus low Interference from the meter to other electrically driven equipment is not anticipated testing was basic standard EN 61326 2013 It meets the electromagnetic Weight Operating environment Meter storage environment Hematocrit Approximate 51 6g battery not included 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 L...

Страница 42: ...tment 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 accordingly...

Страница 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 ...

Страница 44: ...The YSI2500 Biochemistry Analyzer 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: ...ucose concentration 5 55 mmol L 100 mg dL YSI Table2 System accuracy results for glucose concentration 5 55mmol L thin 0 83mmol L 15 mg dL of the laboratory result When the blood glucose is below 5 55mmol L 100mg dL 100 of measured glucose results should fall wi When measured glucose results should fall within 15 of the laboratory result the blood glucose is equal to or above 5 55mmol L 00mg dL 99...

Страница 46: ... Owners Booklet for performing a Control Solution av 2 20mmol L CV 3 69 Intermediate Precision Control Solution av 4 89mmol L CV 2 82 Control Solution av 7 19mmol L CV 1 97 Blood av 2 55mmol L CV 4 3 Blood av 4 79mmol L CV 4 2 Blood av 7 34mmol L CV 2 3 Blood av 11 42mmol L CV 2 6 Blood av 20 5mmol L CV 1 6 Repeatability Control Solution av 10 99mmol L CV 1 77 Control Solution av 18 09mmol L CV 1 ...

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

Страница 48: ...Symbol Index 45 Please dispose of waste according to the local regulations XXXX XXXX ...

Страница 49: ...al 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...

Страница 50: ...03 Version A 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 ...

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