Bioland Technology BGMB002 Blood Glucose Meter User Manual

Bioland Technology Ltd. Blood Glucose Meter

User Manual

Bioland®Blood GlucoseMeterModel：G-427BManufacturer:BIOLAND TECHNOLOGY LTD.A6b7 (Block G), Shangrong Ind. Zone, Baolong 5th Rd, LonggangDistinct, Shenzhen Guangdong, CHINA 518116G-427BBlood Glucose MeterUser Manual
Page 1 of 19Dear G-427B Blood Glucose Monitoring System Owner:Thank you for choosing thissystem!This manual contains important information youmustknow about thesystem.Please read it thoroughly andcarefully.The system providesNo Code functionwhich means thatyou don't needtocalibrate yourmetermakingiteasierfor the usertomonitor blood glucose athome.Important safety instructionsThe meter and lancing device are for single patient use. Do not share themwith anyone including other family member! Do not use on multiplepatients!All parts of the kit are considered biohazardous and can potentiallytransmit infectious diseases even after you have performed cleaning anddisinfection.Changes or modifications not expressly approved by the party responsiblefor compliance could void the user’s authority to operate the equipment.Read this before usingDANGER - Misuse of this electrical device can cause electrocution, burns, fireand other HAZARDS.Basic safety precautions should always be taken, including all those listedbelow.Close supervision is necessary when equipment is used by, on, or near children,handicapped persons or invalids.The following basic safety notice should always be taken:1. Do not place the device in liquid, nor put it where it could fall into liquid.2. The following basic safety notice should always be taken.3. Use the device only for the intended use described in this manual.4. Do not use adjunct which are not supplied by the producer.5. Do not make the device come into contact with surfaces which are too hot totouch.6. Do not use the device where aerosol sprays are being used.7. Do not use the device if it is not working properly, or if it has been damaged.8. Read all the manual, and practice the test, and then use the product to testyour blood glucose. Do all quality control checks as directed and consult with adiabetes expert.KEEP THESE INSTRUCTION IN A SAFE PLACE
Page 2 of 19BeforeYour BeginInstalling the battery1. Open the battery cover on the back of meter.2. If replacing the batteries, please remove the used batteries.3. Insert 2 new (AAA) batteries with correct +/- direction.4. Close the battery cover.Environment Protection – Waste electrical products should not be disposed ofwith household waste. Please recycle where facilities exist. Check with yourlocal Authority or retailer for recycling advice.
Page 3 of 19INTRODUCTION TO THE SYSTEMABOUT YOUR SYSTEMIntended UseThe G-427B Blood Glucose Monitoring System is intended for use in thequantitative measurement of glucose in capillary whole blood from thefinger. It is intended for use by people with diabetes mellitus at home as anaid in monitoring the effectiveness of a diabetes control program. TheG-427B Blood Glucose Monitoring System intended to be used by a singleperson and should not be shared.The Blood Glucose Monitoring System is intended for self-testing outsidethe body (in vitro diagnostic use) by people with diabetes at home as anaid to monitor the effectiveness of diabetes control. The Blood GlucoseMonitoring System is not to be used for the diagnosis of or screening ofdiabetes, or for neonatal use.The Test Strips are for use with the Blood Glucose Meter to quantitativelymeasure glucose drawn from the fingertips.The control solutions is intended for use with the system, to check that theglucose meter and test strips are working properly and that you are doingthe test correctly. The solutions contain a known range of glucose, asindicated on the strips vial bottles.WarningsThe system is intended for use outside the body (in vitro diagnostic use). Itis for single-patient use. It should be used only for testing glucose (sugar)and only with fresh capillary whole blood samples taken from the finger.The system is intended for use at home. It should not be used for thediagnosis of diabetes or for the testing of newborns.The System is intended for self-testing outside the body (in vitrodiagnostic use) by people with diabetes at home as an aid to monitor theeffectiveness of diabetes control. Alternative site testing should be doneonly during steady – state times (when glucose is not changing rapidly).The G-427B blood glucose test strips are for use with the Blood GlucoseMeter to quantitatively measure glucose in fresh capillary whole bloodsamples drawn from the fingertips.The Taidoc control solutions is intended for use with the System, to checkthat the glucose meter and test strips are working properly and that you aredoing the test correctly. These solutions contain a known range of glucose,as indicated on the strips vial bottles.This device is not intended for use in healthcare or assisted-use settingssuch as hospitals, physician’s offices, or long-term care facilitiesbecause it has not been determined to be safe and effective for use inthese settings, including for routine assisted testing or as part ofglycemic control procedures.Use of this device on multiple patients may lead to transmission ofHuman Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV),Hepatitis B Virus (HBV), or other bloodborne pathogens.
Page 4 of 19Test principleThe test is based on the measurement of electrical current generated by thereaction of glucose with the reagent of the strip. The meter measures the currentand displays the corresponding blood glucose level. The strength of the currentproduced by the reaction depends on the amount of glucose in the bloodsample.Contents of the kitsA MeterOwner’s ManualTwo AAA Alkaline BatteriesTest Strips (Optional)Lancing DeviceSterile Lancet (Optional)TaiDoc Control Solution (Optional)NOTE:The Lancing Device can be used for several times, however the sterilelancet should be changed after each use.Sterile lancet and control solution are not included in the standard kit.There are three levels for the control solutions: low, normal and highavailable, please contact the place of purchase for more information.If any items are missing from your kit or opened prior to use, please contactlocal customer services or place of purchase for assistance.Blood Glucose Meter1. Strip portWhere you insert the test strip intostrip port, the meter will turn onautomatically.2. Strip ejectorSlide forward to eject the test stripafter test.3. LCD DisplayIt guides you through the test usingsymbols and simple messages4. "M" ButtonIt is used to turn on the meter enterthe memory mode5. "S" ButtonIt is used to set up the meter
Page 5 of 19Meter Screen Display Message1) Blood dropsymbolFlashes when it isready to apply theblood sample.2) Low batterysymbolAppears when thebattery power islow.3) Test strip symbolAppears when themeter is turnedon.4) Test result areaDisplays glucoseresults5) Measurement unitAppears with the test result in mg/dL6) Bluetooth Symbol7) CTL symbolAppears when doing a control test and indicates that the result won’t bestored in the memory8) Date9) Memory symbolAppears when you review the memory10) Time11) Day averageIndicate that the displayed test result is an average valueTest StripEach strip can be used only once. The test strip consists of the following parts:1-Absorbent holeApply a drop of blood here. The blood will be drawn inautomatically.2-Confirmation windowThis is where you confirm if enough blood has beendrawn into the absorbent hole of the strip.3-Test strip handleHold this part to insert the test strip into the slot.4-Contact barsInsert this end of the test strip into the meter. Push it infirmly until it will go no further.Attention!Test results might be wrong if the contact Bar is not fullyinserted into the test slot.The front side of the test strip should face up wheninserting the test strip.
Page 6 of 19Setting the meter and deleting the memory1. Setting the date and time1.1 Setting the YearPress and Hold “S” button for 3 seconds, until the last twodigits of the year will flash on the screen (for example, “14”equals 2014). Press “M” button until the correct yearappears. Press “S”.1.2 Setting the monthWith the month flashing, press “M” until the correct monthappears. Press “S”.1.3 Setting the dayWith the day flashing, Press “M” until the correct dayappears. Press “S”.1.4 Setting the AM/PMWith the AM or PM flashing, Press “M” until the correctone appears. Press “S”.1.5 Setting the hourWith the hour flashing, Press “M” until the correct hourappears. Press S“.1.6 Setting the minuteWith the minute flashing, Press “M” until the correctminute appears. Press “S”.2. Set the unit(mg/dL or mmol/L)2.1 mg/dL → mmol/LWith the “mg/dL” displaying, press “M” button untilthe “mmol/L” appears, press “S” button twice againuntil the meter turn off.2.2 mmol/L → mg/dLWith the “mmol/L” displaying, press “M” buttonuntil the “mg/dL” appears, press “S” button twiceagain until the meter turn off.Deleting the MemoryPress “S” then “dEL” will display with flashing “M”.Press “M” once, to confirm delete, press “M” buttonagain to delete ALL memory. The meter thendisplays “OK”, which means that the memory isdeleted. If you don’t want to delete the memory,press the S button to skip this step. The meter willautomatically turn “OFF”, and the set up will becompleted.NOTE:The date, time, unit and memory deletion can ONLY be set in the settingmode.When the meter is in setting mode, if no button is pressed within 3 minutes,the meter will turn off.No set up necessary, meter is pre-set. Meter is pre-set for Eastern StandardTime. Please refer to page 13 of this manual for set up instruction.
Page 7 of 19The two measuring modesThe meter provides you with two modes for measuring, General and CTL. TheCTL mode should be used when a control solution is being tested. See the tablebelow.ModesUse whenGeneral test (not display)Any time of day without regard to timesince last mealCTLTesting with the control solutionYou can switch between each mode by:1. Start with the meter turned off. Insert a teststrip to turn on the meter, the screen willdisplay a flashing blood drop and Bluetoothsymbol, time and date.2. Press “S” to select General or CTL mode.Testing with blood sampleCAUTION:To reduce the chances of infection:Choose a clean, dry work surface.Never share a lancing device and lancet with another person.Always use a new and sterile lancet. Lancets are for single use only.Always use a new test strip. Test strip are for single use only.Avoid getting lotion, oils, dirt or debris in or on the lancet and lancingdevice.Note:Before testing, please read the following steps thoroughly and carefully,please relax and do the test step by step. Simplifying or changing the testprocedure may produce inaccurate results.
Page 8 of 19Overview of the Lancing DeviceA. Device CapB. HandleC. Needle CapD. Needle HolderE. Device BodyF. Connecting CollarG. Adjustable tipH. Release ButtonI. Ejection ButtonJ. Device control cap onthe lancets and thelancing device.If your lancing device differs from the one shown here, please refer to themanufacturer’s manual to ensure proper usage.NOTE:To reduce the chance of infection:Never share a lancet or the lancing device.Always use a new, sterile lancet. Lancets are for single use only.Avoid getting hand lotion, oils, dirt, or debris when handling the lancets.Setting Up the Lancing Device1. Screw the device cap off.2. Put the needle into theneedle holder until thebottom.3. Screw the needle cap andput it in the recyclingdustbin.4. Cover the cap5. Adjust the proper level(usually level 3)6. Aiming at the sterilizedpart for blood-taking, pressthe blue release key to finishblood taking.7. Screw the device cap.8. Push the ejection buttonand discard the used lancetin appropriate container.9. Cover the device cap.NOTE:The adjustable tip offers 5 levels of skin penetration. Twist the adjustable tip tothe proper level:1-2 level for soft or thin skin3 level for average skin4-5 level for thick or calloused skin
Page 9 of 19Preparing the puncture siteStimulating blood perfusion by rubbing the puncture site prior to bloodextraction has a significant influence on the glucose value obtained. Blood froma site that has not been rubbed exhibits a measurably different glucoseconcentration than blood from the finger. When the puncture site was rubbedprior to blood extraction, the difference was significantly reduced.Please follow the suggestions below before obtaining a drop of blood:Rub the puncture site for about 20 seconds before penetration.Select the puncture site at the fingertips.Clean the puncture site using cotton moistened with 70% alcohol and let itair dry.Fingertip testingHold the lancing device firmly against the side ofyour finger. Press the release key. You will hear aclick, indicating that the puncture is complete.NOTE：Choose a different spot each time you test. Repeated punctures at the samespot may cause soreness and calluses.It is recommended to discard the first drop of blood as it might containtissue fluid, which may affect the test result.Performing a Blood Glucose TestStep 1Wash hands with soap and warm water.Step 2Remove a test strip from its vial. With clean, dry hands, you may touch the teststrip anywhere on its surface. Do not bend, cut or modify the test strips in anyway. Remove the test strip from the vial and use it instantly.Step 3Insert the test strip into the meter's test port and the meter isturned on. The screen will display a flashing blood drop andBluetooth symbol, time and date.NOTE: Be sure to use G-427B blood glucose test strips, othertest strips may not produce an accurate result.Step 4When the blood drop symbol flashes on the screen, you may selectthe appropriate measurement mode, for selecting the measurementmode of Control (CTL) or General, please refer to the “The twomeasuring modes” section.Step 5Apply your blood to the absorbent hole of the test strip. For collecting bloodsample, please refer to the “Preparing the puncture site” section.Step 6As soon as enough blood has filled the confirmation window of thetest strip, you will hear a beep letting you know the test has begun.
Page 10 of 19A countdown of 5 seconds starts.Note: make sure the confirmation window of the Test Strip is completely filledwith your blood sample.Step 7Your blood glucose level, along date and time appears on thedisplay. Blood glucose results are automatically stored in thememory.When Bluetooth connected, Bluetooth symbol flashing, andwaiting for other device with Bluetooth to scan and connect, thenupload the test results date.NOTE:The results obtained from this meter are plasma-calibrated. This helps you andyour physician or other qualified healthcare provider to compare your meterresults with laboratory tests. Reference to the instructions given by yourphysician or other qualified healthcare provider, do not deviate from theseinstructions on the basis of the result without first consulting your physician.Step 8Eject the used test strip and remove the lancet. To eject thetest strip, point the strip at a disposal container for sharpobjects. The meter will switch itself off automatically afterthe test strip is ejected.Please wash hands thoroughly with soap and water afterhandling the meter, lancing device, or test strips.Reference valueTime of dayNormal plasma glucose rang for people withoutdiabetesBefore breakfast (fasting)<100 mg/dLTwo hours after meals<140 mg/dLSource: American Diabetes Association. Standards of Medical Care inDiabetes-2012.Diabetes Care 2012,35（Suppl.1) S11-S63.Note: Please work with your doctor to determine a target range that works bestfor you.Comparing Meter and Laboratory ResultsThe meter provides you with whole blood equivalent results. The result youobtain from your meter may differ somewhat from your laboratory result due tonormal variation. Meter results can be affected by factors and conditions that donot affect laboratory results in the same way. To make an accurate comparisonbetween meter and laboratory results, follow the guidelines below.Before going to the lab:Do a control solution test to make sure that the meter is working properly.Fast for at least eight hours and then do comparison tests, if possible.Take your meter with you to the lab.While staying at the lab:Make sure that the samples for both tests are taken and tested within 15 minutesof each other.Wash your hands and then obtain a blood sampleNever use your meter with blood that has been collected in a gray top testtube.Use fresh capillary blood only.
Page 11 of 19CONTROL SOLUTION TESTMaterial needed:Glucose MeterTest stripsTaiDoc Control solutionWhen to do a control solution testWhen you suspect that the meter or test strips are not working properly.If your blood glucose test results are not consistent with how you feel.After the test strips are exposed to extreme conditions.After dropping the meter.The control solution is to check that the meter and the test strips can worktogether as a system and work correctly.How to do a control solution testStep 1Insert the test strip into the meter. Wait for the meter to display the dropsymbol.Step 2You may press “S” button to select CTL mode, forselecting the CTL mode, please refer to the “The twomeasuring modes” section.Step 3Apply the control solutionShake the control solution vial thoroughly before use.Squeeze out a drop and wipe it off, then squeeze another drop and place it onthe tip of the vial cap.Hold the meter to move the absorbent hole of test strip so it touches the drop.Once the confirmation window fills completely, the meter will begin countingdown.To avoid contaminating the control solution, do not directly apply controlsolution onto a strip.Step 4The result of the control solutions test appears on the display. The result willnot be stored under CTL mode.The result of the control solutions test should be within the range printed on thetest strip vial label. If the test results falls outside the specified range printed ontest strip vial label, repeat the test. Results falling outside the specified rangemay be caused by:Error in performing the testExpired or contaminated Control SolutionExpired or contaminated Test StripMalfunction of your MeterIf you continue to get control solution test results that fall outside of the rangeprinted on the vial, the system may not be working properly, Do not use themeter. Please contact your customer support immediatelyNOTE:Do not use the expired control solution. Only use the TaiDoc controlsolution, you can purchase this product through visits the website:www.taidoc.com.Users should periodically review their technique and compare a resultobtained with their meter to a result obtained using a laboratory method ora well-maintained and monitored system used by your healthcare provider.
Page 12 of 19Viewing Results on the MeterYour meter stores the 500 most recent blood glucose test results with dates andtimes. It also provides 7-, 14-, 21-, 28-, 60- and 90-day averages of your bloodglucose test results.Note: The control solution readings are not included in the average of yourresults.Recalling the Stored Test Results1. Start with the meter off, press the “M” button to turn on themeter. The “ ” symbol will flash with the time and datedisplayed on the screen.2. Press “M” again, the most recent test results with date and time will display.Press “M” once more and the next most recent test results will appear. Eachtime you press and release “M”, the meter will recall up to your last 500 testresults in order. Press the “S” to turn off the meter. When the memory is full,the oldest result is dropped and the newest result is added.Reading the Average of Blood Glucose ResultsWhen the meter is off, press and hold the “M” button until theDAY AVG flashing, release button then 7-day average resultsappear with “n024” (means 24 records to be averaged) on thescreen. Press the “M” button to review the 14-, 21-,28-, 60- and90-day general averages. Press the “S” button to turn off themeter.Note: The control solution readings are not included in the average of your results.When your glucose value is less than 20mg/dL, you will see the following message“Lo”; When your glucose value is high than 600mg/dL, you will see the followingmessage “HI”Care and storage for your systemHandle the meter with care. Dropping or throwing the meter may causedamage to the device.Don't expose the Blood Glucose Monitoring System, Test strip, and ControlSolution, to extreme conditions, such as high humidity, heat, freezing cold ordust. The storage conditions for the test strips are 39 ℉~86℉, Humidity ＜80%RH. Storage conditions for the meter are -40 ℉~131 ℉, Humidity ＜80%RH.Always wash your hands with soap and water and rinse and dry completelybefore handling the Blood Glucose Monitoring system and Test strip.Use CaviWipes (see below) to clean the Blood Glucose Monit oring System.Discard the used lancet into a container for sharp objects.
Page 13 of 19Cleaning and DisinfectionThe cleaning and disinfection is absolutely necessary for the test procedure,because cleaning can insure the meter works well (for example, display will beclear to see after cleaning); and disinfection can avoid the infection to you or to theother people, and the cross-infection. We strongly warn that the device should becleaned and disinfected following use on every patient. And we suggest you usethe following product: CaviWipes (EPA registration number：46781-8）. You canpurchase this product according to the following information: visit the web site:www.metrex.com or contact Metrex at 800-841-1428 for product or technicalinformation. CaviWipes are also available at www.amazon. com or via a Googlesearch.The meter for single-patient use and the lancing devices may be cleaned 5-6 timesper day (Test 5-6 times every day), so the meter will be cleaned and disinfect about11000 cycles that include cleanings plus disinfections (1 cycle = 1 cleaning + 1disinfection) during its 5 years life cycle.1. Before the test, the user should clean and wash hands. If you are a caregiver,(not the patient), please use disposable gloves.2. After test, take one wipe to clean the meter’s housing, buttons, lens, mark, usbcover and support block, including its front and back for 10 seconds for cleaninguntil there is no soil on the surface. Then disinfect the meter’s housing, buttons,lens, mark, usb cover and support block use another wipe for 2 min, keep thesurface wet for 2 min.3. Take off the glove; discard carefully according to your health-care provider’sinstruction.Note:1. Each disinfection step requires a pre-cleaning step.2. If the meter is being operated by a second person who is providing testingassistance to the user, the meter and lancing device shall be cleaned anddisinfected first.3. The users should wash hands thoroughly with soap and water after handling themeter, lancing device, or test strips.Specification1. Model: G-427B2. Machine size: 90mm (L)×54mm (W)×13mm(H)3. Weight: 73g (excluding batteries)4. Measuring method: Amperometric technology using glucose oxidase5. Measuring range: 20 mg/dL ~600 mg/dL6. Memory: 500 blood glucose tests7. Display: LCD display with backlight8. Power source: DC 3V (AAA×2 alkaline batteries)9. Battery Life: Approx. 500 normal tests10. Storage Condition (system: meter and test strips): 39.2℉~104 ℉and below85% relative humidity11. Storage Condition (meter): -40 ℉~131 ℉,Humidity ＜80%RH, 700hPa ~1060hPa12. Operating conditions: 50℉~104℉, Humidity:25%~80%RH13. Blood Source: Fresh capillary whole blood14. Blood Volume: Minimum 0.7 micro liter.15. Use life: five years.
Page 14 of 19Limitations of use:The blood Monitoring System is not intended for use on neonates.The blood Monitoring System is not intended for use on artery blood,neonates’ serum and plasma.The system can be used up to an altitude of 10744 feet.The following substances at levels greater than normal or therapeutic levelsmay cause significant interference (affect the result by greater than 10%)resulting in an inaccurate result: ascorbic acid, uric acid, hemoglobin ，acetaminophen, Dopamine, L-dopa, L-dopa and Tolbutamide etc. These sub-stances do not affect test results in normal concentration but may affect testresults in high concentration. Do not use haemolysis sample, icterus sampleor high lipemia samples.The following compounds, when determined to inexcess of their limitation, may produce inaccurate results:CompoundLimitation1. Acetaminophen≤ 8.0 mg/dL2. Ascorbic Acid≤ 5.0 mg/dL3. Bilirubin≤ 90 mg/dL4. Cholesterol≤ 500 mg/dL5. Creatinine≤ 5.0 mg/dL6. Dopamine≤ 2.0 mg/dL7. EDTA≤360 mg/dL8. Galactose≤ 900 mg/dL9. Gentisic Acid≤ 5.0 mg/dL10. Glutathione≤53 mg/dL11. Haemoglobin≤500 mg/dL12. Heparin≤8000 U/dL13. Ibuprofen≤50 mg/dL14. Icodextrin≤13 mg/dL15. L-dopa≤ 10 mg/dL16. Maltose≤ 900 mg/dL17. Methyldopa≤ 3.0 mg/dL18. Pralidoxime Iodide≤25 mg/dL19. Salicylate≤60 mg/dL20. Tolazamide≤100 mg/dL21. Tolbutamide≤ 400 mg/dL22. Triglycerides≤ 2000 mg/dL23. Uric Acid≤ 8.0 mg/dL24. Xylose≤100 mg/dLPatients undergoing oxygen therapy may yield falsely lower results.Not for use for patients in a hyperglycemic-hyperosmolar state, with orwithout ketosis.Not for use on critically ill patients.Not to be used for patients who are dehydrated, hypertensive, hypotensive orin shock.Very low (less than 20%) or very high (more than 60%) red blood cell count(hematocrit) can lead to incorrect test results. If you do not know yourhemarocrit level, please consult your health care provider.High temperature (more than 104 ℉) and low temperature (less than 50℉)may lead to incorrect test results.High humidity (more than 80%) and low humidity (less than 25%) may leadto incorrect test results.
Page 15 of 19DISPLAY MESSAGEMESSAGEWHAT IT MEANSACTIONBlood glucose level is lowerthan 20mg/dlThe message indicates verylow blood sugar. You shouldconsult with your healthcareprofessional.Blood glucose level is higherthan 600 mg/dlThis indicates severhyperglycemia (high bloodglucose).You should seekimme- diate medicalassistance.Meter is ready to test controlsolution under the CTL state.Please place a drop ofcontrol solution onto the testwell of test strip.Battery power is low.Please change thebattery.Use a used test stripPlease use a new strip andre-testError massage indicates thatyou may remove prematurelythe strip afeter applying bloodto the absorbent holeTry again with a new teststripProblem with the meterRe-test with a new test strip.If the problem is stillunsolved, please call thecustomer care line for help.Environmental temperature islower than 50℉~104℉Please test at anenvironmental temperaturewithin 50℉~104℉operationrangeProblemsProblemsCausesSolutionsDisplay remainsblank after thetest strip hasbeen insertedinto the Meter.11. Battery may be installedimproperly.22. Battery power is too low toruse.33. Too much time has passedbetween inserting the TestStrip and perfor- ming thetest.44. Test Strip has not been fullyinserted into the Meter.1.Install the Batterycorrectly.2.Replace with new Battery.3.Reinsert the Test Strip intothe Meter.4.Reinsert the Test Strip intothe Meter.Test results areincon sistent orControlSolution testresults are notwithinthe specifiedrange.11. Not enough sample in theTest Strip.2. Test Strip or ControlSolution has expired.33. Test Strip has been damageddue to heat or humidity sothat sample cannot be appliedor the speed of applyingsample is too slow.44. System is not per- formingdue to the environment beingabove or below roomtemperature.1. Redo test with new test stripand make sure that enoughsample has been added.2. Redo test with new teststrip.3. Perform a Control Solutiontest using a new Test Strip. Ifresults are still out of range,replace with new vial of TestStrips.4. Bring System to a roomtemperature environment andwait approximately 30minutes before per- forming anew test.The Metercountdown didnot start.Test Strip has not beeninserted correctly.Use a new Test Strip and redothe test.
Page 16 of 19Performance CharacteristicsPrecisionWithin Run Precision (300 Venous Blood Tests per Glucose Level)Target Glucose(mg/dL)Mean Glucose(mg/dL)Standard Deviation(mg/dL)Coefficient ofVariation (%)Results show that the greatest variability observed between test strips when testedwith blood is 2.44% or less.Intermediate precisionMean (mg/dL)44.4108.1342SD (mg/dL)3.23.37.1CV (%)-3.32.0Your G-427B Meter result may vary slightly from you actual blood glucose value.This may be due to slight differences in technique and the natural variation in thetest technology.The chart below shows the results of a study where 350 typical users used theG-427B meter to test their blood glucose level. In this study, the G-427B metergave result within 15% of their true blood glucose level 340 out of 350 times.Difference range betweenthe true blood glucose levelWithin5%Within10%Within15%Within20%and the G-427B meterresultThe percent(and number) ofmeter results that match trueblood glucose level withinx%Traceability of glucose monitoring systemThe results of G-427B blood glucose monitoring system were compared to parallelresults obtained on YSI-2300, which is the manufacturer's standard measurementprocedure.BIOLAND TECHNOLOGY LTD.No. A6b7 (Block G) ShangRong Industrial Zone No. 5 Baolong Road, BaolongCommunity Longgang District 518116, Shenzhen, Guangdong PEOPLE’SREPUBLIC OF CHINAToll free telephone number: 8002182838
Page 17 of 19Electrical and safety standardsThis meter complies with CISPR 11: Class B (Radiated Only). Emissions of theenergy used are low and not likely to cause interference in nearby electronicequipment. The meter has been tested for immunity to Level 3 electrostaticdischarge as specified in IEC 61326. This meter complies with immunity to radiofrequency interference over the frequency range 80MHz to 2.5GHz at 3V/m asspecified in IEC 61326-1 or 61326-2.The meter meets the requirements for immunity to electrical interference at thefrequency range and test level specified in international standard ISO 15197.Use of this meter near electrical or electronic equipment that are sources ofelectromagnetic radiation, may interfere with proper operation of this meter. It isadvisable to avoid testing in close proximity to sources of electromagneticradiation.Common sources of electromagnetic radiation includes mobile phones, walkietalkies or garage door openers.Do Not use the equipment where aerosol sprays are being used, or when oxygen isbeing administered.FCC Requirementchanges or modifications not expressly approved by the party responsible forcompliance could void the user’s authority to operate the equipment.This device complies with Part 15 of the FCC Rules. Operation is subject to thefollowing two conditions:(1) this device may not cause harmful interference, and(2) this device must accept any interference received, including interference thatmay cause undesired operation.Note: This equipment has been tested and found to comply with the limits for aClass B digital device, pursuant to Part 15 of the FCC Rules. These limits aredesigned to provide reasonable protection against harmful interference in aresidential installation. This equipment generates, uses, and can radiate radiofrequency energy, and if not installed and used in accordance with the instructions,may cause harmful interference to radio communications. However, there is noguarantee that interference will not occur in a particular installation. If thisequipment does cause harmful interference to radio or television reception, whichcan be determined by turning the equipment off and on, the user is encouraged totry to correct the interference by one or more of the following measures:–Reorient or relocate the receiving antenna.–Increase the separation between the equipment and receiver.–Connect the equipment into an outlet on a circuit different from that to whichthe receiver is connected.–Consult the dealer or an experienced radio/TV technician for help.This equipment complies with FCC radiation exposure limits set forth for anuncontrolled environment. This equipment should be installed and operated with aminimum distance of 20cm between the radiator & your body. This transmittermust not be co-located or operating in conjunction with any other antenna ortransmitter.

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