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Summary of Contents for Sejoy BG-202
- Page 1 BG-202 Blood Glucose Monitoring System Owner’s Booklet BG-202 Advanced Diabetes Management System...
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Page 2: Table Of Contents
Contents Introduction ················································· · ·············································· ··········································································· Important Safety information ························································· Important Health-Related information ···································································································· Limitations Getting to know your system ··················································································· ························································································ Included in your kit ·············································································································· Meter ·········································································································· Test Strip ······························································································ Lancing Device ·························································· · ························································· Lancet Setting up your meter··································································································· ·····················································································... - Page 3 Troubleshooting ··················································································································· Technical information ···································································································· ················································································································ Specifications Disposing of the meter, test strips, lancets and batteries ········································· Warranty ································································································································· Traceability ········································································································································ Performance Characteristics ··································································································· Symbol Index ················································································································ Appendix ·································································································································...
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Page 4: Introduction
Before you start testing, carefully read this Intended Use The Sejoy BS-102 Test Strips are used with the Sejoy BG-202 Blood Glucose Meter to quantitative measure blood glucose with fresh capillary whole blood or venous whole blood. The system is intended for in vitro diagnostic home-use and by healthcare professional in a clinical setting as an aid to monitor the effectiveness of diabetes control. -
Page 5: Important Safety Information
Introduction Important Safety information Warning • During normal testing, any blood glucose meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from blood-borne pathogens, even after you have performed cleaning and disinfection. -
Page 6: Important Health-Related Information
Introduction Important Health-Related information ·Patients undergoing oxygen therapy may receive inaccurate results. ·Some people with diabetes do not experience symptoms of low blood sugar (hypoglycemia). Others, such as children or people who are unconscious or have certain disabilities, may not be able to communicate their symptoms to caregivers. - Page 7 Introduction ·The system is designed for using with fresh capillary whole blood, Do not use arterial blood, serum or plasma. ·Do Not test on neonatal sample(new born). ·Inaccurate test results may be obtained at high altitude more than about 3048 meters above sea level.
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Page 8: Limitations
Introduction Limitations The interference listed below have been tested and shown no apparent influence on results at the normal or higher therapy levels. Acetaminophen 2.0 mg/dL Levodopa No clear range of effective drug concentration Ascorbic acid 2.0 mg/dL Creatinine 1.5 mg/dL Ibuprofen 4.2 mg/dL Dopamine... -
Page 9: Getting To Know Your System
Getting to know your system INCLUDED IN YOUR KIT a. Meter (battery included) b. Test Strips c. Lancing Device d. Sterile Lancet e. Control Solution f. Carrying case Manufacturer of Lancing Device and Sterile Lancet Manufacturer of Lancing Device and Sterile LancetShandong Lianfa Medical Plastic Products Co.. -
Page 10: Meter
Getting to know your system a. Meter Strip Port Battery Cover BG -2 02 “S” Button Battery Compartment “M”Button Test Strip Reminder Apply Blood Sample Reminder Memory Temperature is out of range Low Battery Reminder Display Test Result Average mg/dL mmol/L Measuring Unit Time Alarm Clock Reminder... -
Page 11: Test Strip
Getting to know your system b. Test Strip Top Edge Contact Bars Confirmation Window Contact Bar: Insert it into strip port. Push it all the way until it goes no further. Top Edge: Apply blood sample here. Confirmation Window: Sample checking area. Important: the meter should only be used with BS-102 test strips. -
Page 12: Lancing Device
Getting to know your system c. Lancing Device Lancet Cap Trigger Button Arrow Adjustable Tip Sliding Barrel Lancing Device Cover Lancet Carrier Lancet Ejector d. Lancet Protective Cap Lancet Pin... -
Page 13: Setting Up Your Meter
Setting up your meter When using the meter for the first time, please set the parameters of the meter. With the meter off, long-press button “S” to enter setting mode. ① Set the month Press and release the button “M” to advance one month until the correct BG -20 2 month appears. - Page 14 Setting up your meter ④ 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. ⑤ Set the time format The meter can display the time in either an AM/PM (12-hour) or a 24:00 (24-hour) format.
- Page 15 Setting up your meter ⑦ Set the alarm clock The meter can set an alarm clock to remind you of the testing time. Press button “M” to check the alarm function. If the alarm is on, press button “S”, the time figure is flashing.
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Page 16: Testing Your Blood Glucose
Testing your blood glucose Preparing the lancing device Warning • During normal testing, any blood glucose meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from blood-borne pathogens, even after you have performed cleaning and disinfection. - Page 17 Testing your blood glucose Preparing the lancing device ① Screw off the lancing device cover. ① ② Insert a new lancet into the lancet carrier firmly. ③ Hold the lancet needle cover and gently twist it off the lancet. ④ Put on the lancing device cap. Avoid touching the trigger button.
- Page 18 Testing your blood glucose Preparing the lancing device ⑥ Hold 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.
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Page 19: Blood Sampling
Testing your blood glucose Blood Sampling ① Wash your hands and the puncture site with an alcohol swab or soapy water. Rinse and dry thoroughly. ② Position the end of the adjustable tip 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. - Page 20 Testing your blood glucose Blood Sampling IMPORTANT: • Use only Test Strips BS-102. • Make sure your meter and test strips are about the same temperature before you test. • Testing must be done within the operating temperature range 10℃~40℃ (50℉~104℉). For the most accurate results, test at room temperature 20℃~25℃...
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Page 21: Testing
Testing your blood glucose Testing ① With meter off or in setting mode and memory mode, insert a test strip to enter into testing mode. Note: If you do not start the test within three minutes, the meter will turn off. To restart your meter, take out the unused test strip and reinsert it into the meter. - Page 22 Testing your blood glucose Testing ④ Apply the sample Gently touch the channel to the edge of the blood drop. Note: • Discard the first drop of blood. Do Not smear or scrape the drop of blood with the test strip. •...
- Page 23 Testing your blood glucose ⑦ Delete the memory If you don’t want to keep the test result, 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. ⑧...
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Page 24: Interpreting Unexpected Test Results
Testing your blood glucose Interpreting unexpected test results The meter can accurately measure blood glucose concentrations between 2.2 to 33.3 mmol/L (40 to 600 mg/dL). Expected Blood Glucose Level [1, 2, 3] Normal Blood Glucose Range Time 3.9-5.8 mmol/L 70-105 mg/dL Before breakfast Before lunch or supper 3.9-6.1 mmol/L 70-110 mg/dL... - Page 25 Testing your blood glucose Interpreting unexpected test results ② High glucose results If your test is above 33.3 mmol/L( 600 mg/dL ), HI will appear on the display screen. This indicates severe hyperglycemia (high blood glucose). mmol/L • HI Reading with Symptoms If you feel symptoms such as fatigue, thirst, excess urination, or blurry vision, then follow your doctor’s recommendation to treat hyperglycemia.
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Page 26: Comparing Your Meter Result To A Laboratory Result
Comparing Your Meter result to a Laboratory result Comparing your meter's results with laboratory results periodically. The results of the Sejoy BG-202 meter are plasma equivalent. This method will help you and your healthcare professional compare your meter results with laboratory test results. The Sejoy BG-202 meter's test result and laboratory test results both are expressed in plasma-equivalent units. -
Page 27: Memory And Averages
Memory and averages Storing Blood glucose and Control Test results 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. - Page 28 Memory and averages ③ View 7-, 14-, 28-day average Press and release “S” button to enter the average value display. The first memory display screen you see is your mmol/L 7-day average. This average includes all the readings from the last period days.
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Page 29: Control Solution Testing
• 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. -
Page 30: Performing A Control Test
Control solution testing Performing a control test ① Insert a test strip to turn the meter on ② System check screen Each time the meter powers on, this screen briefly appears so that you can make sure the display is mg/dL mmol/L working properly. - Page 31 Control solution testing Performing a control test ⑤ Touch and hold the hanging drop of control solution where the narrow channel meets the TOP EDGE of the test strip. Make sure the confirmation window fills completely. Control solution should not be applied to the flat face of the test strip.
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Page 32: Understanding Out-Of-Range Control Test Results
• 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 Not use the meter, the test strips, or the control solution. - Page 33 Control solution testing ⑦ Delete the memory If you don’t want to keep 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. ⑧...
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Page 34: Maintenance
Maintenance Replacing the battery Your meter comes with one preinstalled, 3 volt, type 2032, button 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 battery. Important: When this symbol appears, you should replace the battery immediately. -
Page 35: Meter Maintenance
Maintenance Meter maintenance Avoid getting dirt, dust, blood, control solution, water, or any other liquid in the meter’s test strip port. Important: Never immerse the meter in water or any other liquid. This may cause inaccurate reading or meter malfunction. Storing your system Store your meter, test strips, control solution and other items in your carrying case after each use. - Page 36 Maintenance We recommend to disinfect periodically. When you assist others to make blood glucose testing with the meter, please disinfect it or wear gloves to protect yourself. Cleaning your meter and lancing device To clean your meter and lancing device, wipe the outside with a soft cloth damped with water and mild detergent.
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Page 37: Troubleshooting
Troubleshooting What to do Message Possible Cause Remove the battery and The system check reinsert it after 30 seconds. may be failed. If it still doesn’t work, please contact the vendor. Make sure that the strip The test strip may be model is correct and used or damaged. - Page 38 Troubleshooting Battery power is low. Replace the battery soon. Place the system in The meter is out of appropriate operating operating temperature environment for 30 range. minutes before retesting.
- Page 39 Troubleshooting Meter does not enter the test mode after inserting a test strip. Probable Cause What to Do Replace the battery (and reset the date and Battery power is low. time,if necessary.) The battery is installed Check that the battery is installed correctly. incorrectly or there is no battery in the meter.
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Page 40: Technical Information
Technical information Specifications Product description BG-202 Blood Glucose Monitoring System Assay method Glucose oxidase biosensor Measurement range 2.2-33.3mmol/L (40~600mg/dL) Sample Fresh capillary whole blood or venous whole blood Approximate 1 microlitre Sample size Response time 5 seconds Coding No coding Battery One 3.0V CR2032 button battery, replaceable... - Page 41 Technical information Specifications LCD size 34.6*31.1mm (L*H) Weight Approximate 41.2g, battery not included 10℃~40℃ (50℉~104℉) Operating environment 10 ~ 70% RH (non-condensing) -20℃~ 55℃ (-4℉~131℉) Meter storage environment 10 ~ 70% RH (non-condensing) Up to 10,000 feet (3,048 meters) Altitude above sea level Hematocrit 30%~55%...
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Page 42: Disposing Of The Meter, Test Strips, Lancets And Batteries
Disposing of the meter, test strips, lancets and batteries Warning • Any product coming in contact with blood is considered contaminated (potentially infectious). • During normal testing, any blood glucose meter may come in contact with blood. • Lancing devices may also be considered sharps. For disposal of sharps, refer to local regulation. -
Page 43: Warranty
Warranty Limited 2-Year Warranty The meter is guaranteed for 2-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. -
Page 44: Traceability
Traceability The traceability of the control solution is referenced to the EKF BIOSEN C line-Clinic glucose 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). -
Page 45: Performance Characteristics
Performance Characteristics The performance of the system has been evaluated both in laboratory and in clinical tests. Range: The display range of the meter is 2.2mmol/L to 33.3 mmol/L (40mg/dL to 600 mg/dL). "HI" and "Lo" messages indicate results outside of this range. •... - Page 46 Performance Characteristics Table3. System accuracy results for glucose between 2.2 mmol/L (40 mg/dL) and 33.3 mmol/L (600 mg/dL) Within ± 0.83 mmol/L or Within ±15% 600/600(100.0%) This study shows that the system compares well with a laboratory method and meets the minimum acceptable performance criteria defined in EN ISO 15197 : 2015.
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Page 47: Symbol Index
Symbol Index Consult instructions for use In vitro diagnostic medical device Serial number Caution Batch code Manufacturer ∑ Contain sufficient for < n > tests Storage temperature limitation Sterilized using ethylene oxide STERILE EO Do not reuse Use by... - Page 48 Symbol Index The Product conforms to the requirements of the EC Directive IVDD (98/97/EC) on in vitro diagnostic medical xxxx devices “xxxx" is the identification number of notify body Keep dry Please dispose of the waste according to the local regulations Direct Current European Authorized Representative...
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Page 49: Appendix
Appendix 1. Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting 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. - Page 50 Document No.: DBG-0104-007 Version: E Date of Issue: 2022. 03 0197 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 Shanghai International Holding Corp.Gmbh (Europe)
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