Fudakang EBGBT Blood Glucose Monitor User Manual 2nd TCF

Fudakang Industrial Co., LTD Blood Glucose Monitor 2nd TCF

User Manual

FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page1/13Instruction for UseBlood Glucose Monitor and Blood Glucose Test StripeB-G-BT,eB-D12-BT,eB-D33-BT,eB-D34-BT,eB-D43-BT,eB-D44-BT,eB-D45-BT,eB-D52-BT，eB-G,eB-D11,eB-D12,eB-D21,eB-D31,eB-D32,eB-D33,eB-D34,eB-D35,eB-D41,eB-D42,eB-D43,eB-D51,eB-D52
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page2/13Table of ContentsI. Standard accessories and product description...................................................................... 1II. Scope and time of testing.............................................................................................................3III. Specifications................................................................................................................................. 3IV. Application and operating environment..................................................................................3V. Operating instructions.................................................................................................................. 4VI. Additional functions..................................................................................................................... 5VII. Description and explanation of icon on LCD........................................................................6VIII. Troubleshooting and precautions.......................................................................................... 7VIIII.Knowledge on blood glucose and diabetes.........................................................................8X. Statements and Declarations...................................................................................................... 9Hand-hold quick blood glucose testing system consists of the following parts.Standard accessories:Blood glucose monitor 1 set(eB-G-BT and suitable for all Blood Glucose monitor)1. Blood glucose test strip box 25 PCS2. Lancing Device 1 PIECE3. Disposable Lancets 25 PCS / BAG4. Alcohol sponge 25 PCS5. Blood glucose device 16. Instruction manual 17. Portable bag 1
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page3/13All the accessories shall be subject to the real packageDescription of model no.: eB-G-BT blood glucose monitorDescription of the DisplayDescription of test strip1. Introduction to the package of boxEach box have 25 pcs single package test strips to prevent each one of test strips being affected with damp.The test strips has been sure of being damped after the single package has been opened for three months anddo NOT use them.2. Introduction to the package of test stripIt should finish the test within five minutes after the test strip is opened, the test strip could be usedfor one time only, do NOT wrap the package and scratch the test strip; do NOT touch the reactionend; ambient temperature: 10℃-40℃(50 °F～104 °F) 。.3. Introduction to the test stripThe product is designed as a disposable test strip for the blood glucose monitor, each strip comprises thefollowing parts.1Confirmation window: the user may see whether there is enough blood got into the reaction area through thiswindow.2②Blood entry: the blood gets into the test strip via this entry.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page4/133③Electrode: insert this end into the corresponding place of the blood glucose tester to start the device,please keep the blue arrowhead side upwards in inserting.1.Testing scope: 2.2 mmol/L～27.8mmol/L (40mg/dL～500mg/dL).2.Testing time: ≤10s.1.Model No.: eB-G-BT(Suitable for eB-D12-BT,eB-D33-BT,eB-D34-BT,eB-D43-BT,eB-D44-BT,eB-D45-BT,eB-D52-BT，eB-G,eB-D11,eB-D12,eB-D21,eB-D31,eB-D32,eB-D33,eB-D34,eB-D35,eB-D41,eB-D42,eB-D43,eB-D51,eB-D52)2.Parameters of blood glucose monitor:(a) Power supply: DC 3.0V (two AAA alkaline batteries);(b) Display mode: mmo1/L or mg/dL display and testing time display;(c) Times of result memory: 180 times;(d) Dimensions: 80mm*58mm*23mm ;(e) Weight: 46g(f) Rated power: 30mW.3.Type of test strip: Siphon type4.Parameters of test strip(a) Dimensions: 32mm×8mm×0.8mm (L*W*D)(b) Nominal weight: 0.5g/piece·The product must be used together with siphon blood glucose test strip produced.·Blood glucose monitor is applicable for out-of-body test only.·Blood glucose monitor is applicable for the test of ending whole blood.Ambient conditions (normal working conditions)(a) Ambient temperature: 10℃-40℃(50 °F～104 °F);(b) Relative humidity: ≤80%;(c) Atmospheric pressure: 700hPa～1060hPa;(d) Power supply: DC 3.0V (two AAA alkaline batteries);1. Use the blood glucose monitor to test the blood glucose. Step1: adjustment of timePower On: Press Power switch for five seconds to enter the setup interface of time. Firstly the Year place shallblink, press Memory key to adjust the year and then further press Power key to enter the adjustment interface ofmonth, use the same operation to finish the adjustment of day, hour and minute.Step 2: Installation of pinhead(1)Open the protective cover of blood taking device;
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page5/13(2)Insert the new blood needle and then use one hand to hold the needle and usethe other hand to open the protective cover;(3)Put the protective cover of blood taking device on;(4)Select the depth of taking blood (1→2→3→4→5), generally the depth of 3 is advised.(5)Pull back the pen to start to take the blood. (Note: do NOT pull the pen by big force to avoid pulling it out).Step 3: Clean your fingersPlease disinfect by the alcohol sponge with dry and clean fingers.※Note: do NOT use the iodine to disinfect.Step 4: Load the batteries (Voice function only suitable for voice model)(1) Press Power switch to turn on the tester and it shall give voice prompt: “Please check the Code card is correctlyinserted and insert the test strip into the slot”. And then please take out the Code card from the box and insert itinto the device, the LCD shall display the password of the bottle/box of test strips, the password must be samewith the correct mode marked on the package.Step 5: Insert the test stripInsert one new test strip and the electrode into the corresponding place of tester. The tester shall display thecode of test strip and the blood entry icon shall blink and voice prompt shall be given: “Please get blood fortesting”.Note: do NOT use your fingers to touch the reaction area and inserting end (electrode area).Step 6: Take bloodMethod: take the ending whole blood: use the disposable blood taking needle to lance the finger to take blood.Step 7: Application of sample(1) Please apply the blood sample at the siphon mouth of reaction area when the LCD displays “Blood Entry”.1. Press Button “Power”shortly to turn on, and 88.8 will be fully displayed.2. Open APK application and select “Blood Glucose Monitor”, then device will be automatically searched out, thenclick corresponding device. After automatically match, measurement is ready to start.3. Insert test paper, and product is going to prompt: Please drip blood to measure.4. After measurement, the result will be displayed on the blood glucose monitor and cell phone at the same time.※If power off, the matched product should be connected to cell phone again.5. If result needs to be sent, please chose the data first, and select the sending method by means of text messageor email while inputting the receiver information.6. Bluetooth function only for Bluetooth model.※It should make the reaction area full of blood by one time, it’s NOT allowed to add the blood for many times.Note: the blood shall be absorbed automatically by the principle of siphon.·Do NOT press the bleeding part by the test strip;·Do NOT use the test strip to scratch blood;·It should finish the test within five minutes after taking out the strip.It shall display the testing result in ten seconds after adding the blood sample,unit: mmol/L or mg/dL.（1）Memory: Press Memory key to enable the LCD to display the latest result with voice (time shall be alsodisplayed), further press Memory key to display the second latest result (time shall be also displayed),operate by the same method till the desired value is displayed.※Long press Memory key for five seconds to delete all values.（2）Calculation of average value: Power ON, press Power and Memory keys for 3 seconds to enable the LCD to
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page6/13display the average value of the latest 14 tests. (The calculation could be made only when there are 14 ormore testing values)（3）Maintenance after using: Do NOT damp the tester and wipe off any liquid at the insert and inside; it should usethe soft cloth to wipe off the dirt on the surface; and the product should be stored under the normaltemperature, do NOT place it in the electromagnetic environment or fall it down.（4）Please take out the batteries if it’s not being used for a long time. （5）Unit: mmol/L or mg/dL （1mmol/L＝18mg/dL）1. The symbol of displayed on LCD in the measurement(a) “888”: self-checking;(b) When “Bottle” displays and blinks, it’s required to insert the Code card;(c) When “Test Strip” displays and blinks, it’ required to insert the test strip;(d) When the symbol of “blood” displays at the top side, it’s required to get the blood;(e) After getting the blood, it shall count down and display at the left side of LCD, the tester enters the self-testingstate;(f) The result shall be displayed in XXX（mmol/L）or XXX（mg/dL）; when the result ＜2.2mmol/L （40mg/dL）,LCD shall display “LO”, and then the result >27.8 mmol/L(500mg/dL), LCD displays “HI”;(g) When LCD displays “Err”, it means the test has error;(h) When the “ “ symbol displays, it means the batteries is used up and should be replaced;(i) When the “thermometer” symbol displays at the upper side of bottle on LCD, it means the ambienttemperature is higher than the normal working condition, it should use the tester in the ambient temperature of10℃-40℃(50 °F～104 °F).(j) When the “month”, “day” and “time” symbol display, it means the date and time of the test.1. Identification of error information and measures（1）“Err”—it means the test has error.Possible reasons: the operating method (step) is wrong; invalid test strip is used; the blood is not enough; theblood is added repeatedly; the ambient temperature is not in the range of 10℃-40℃(50°F～104 °F)the test strip is moved in testing; the tester has fault(s).Suggestion:①Please read the operating manual carefully to use the blood glucose monitorcorrectly and make the test once again by the correct method. ②Pleasecontact our after-sale service department. （2）“LO”—it means the measuringvalue is lower than 2.2 mmol/L（40mg/dL）; “HI”—it means the measuring valueis higher than 27.8 mmol/L (500mg/dL).Suggestion:①Check whether the operation is correct by doing the test once again with theeffective test strip, if the value is not changed.Please consult your physician.②Please contact our after-sale service department.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page7/132. Preventive measure before using(1) Wash hands with clean water and soap and use the alcohol and sponge to disinfect.(2) Ensure that the needle is new and do NOT use the used one.3. Measures as per the measuring result(1) If the result is regarded not to meet the real condition of your body, please check whether the operation iscorrect. And test again by the effective test strip, if the result is still same, please consult your physician intime. Do NOT make change of taking medicine in accordance with the result only.(2) Regularly compare with the measurement made in hospital is necessary, if you feel the symptom is notconsistent with the results. Please consult your physician for further best treatment.4. Factors of affecting the accuracy of result, applicable scope and precautions（1）Factors of disease affecting the result:(a) The packed cell volume is smaller than 35% or bigger than 50%.(b) The capacity of ending blood circulation obstruction blood is reduced, such as serious dehydration,hypotension, shock and ending blood vessel diseases.(c) The level of triglyceride is higher than 57mmol/L. （2）Factors of wrong operation:(a) The blood volume is not enough, the reaction is not full;(b) The initial blood sample is not enough, measuring the test after adding the blood again;(c) The blood sample is polluted;(d) The test strip is pulled out and then inserted;(e) It’s stored in the low temperature (lower than 10℃（50°F）) or measuring with the deep frozen strip;(f) Iodine or chlorine disinfection agent is used;(g) Take blood from the wet finger after being disinfected;(h) It is placed in the high temperature environment longer than 2 minutes after being unpacked.（3）Why the result of testing the ending blood is not consistent with the value of testing the venous blood glucosein hospital? Generally, the venous blood test in hospital it take will have 15% difference if compared to theending blood test .1. The blood volume is not enough which shall make the value of testing lower.2. Pressing the bleeding area shall make a large amount of tissue fluid get into and make the thicknessof blood glucose reduced.3.The Code card is not used or the password is not consistent with the Code on bottle.4. The test strip is out of its service life or the bottle has been opened for more than 3 months or longer; the teststrip is damped or polluted;5.When the alcohol is used for disinfection, the alcohol is not dry or the bleeding area is damped.6. The iodine is used to make the value higher;7.The ambient temperature is not proper (the best temperature should be in the range of 10℃-40℃(50 °F～104 °F)) 。8. Other factors: the capacity of blood corpuscle is bigger than 60%, other glucides and internal substances,
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page8/13medicines (vitamin C) and uric acid.What are blood glucose and the reference standard of blood glucose value?Blood glucose means the glucose in blood, other kinds of glucides such as fructose, disaccharide andpolysaccharide, could not be called blood glucose until they are converted to glucose. The thickness of bloodglucose of a normal person should be stable and balance.Reference standard of blood glucose valueUnit conversion: 1mmol/L=18mg/dLLimosis : 70mg/dL-110mg/dL(3.9mmol/L-6.1mmol/L)30 minutes after dinner: 100mg/dL-180mg/dL (5.6mmol/L-10.0mmol/L)60 minutes after dinner: 90mg/dL-170mg/dL (5.0mmol/L-9.4mmol/L)120 minutes after dinner: 75mg/dL-135mg/dL (4.2mmol/L-7.5mmol/L)180 minutes after dinner: 70mg/dL-110mg/dL (3.9mmol/L-6.1mmol/L)
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page9/13STATEMENTS AND DECLARATIONS:1) This product needs special precautions regarding EMC and needs to beinstalled and put into service according to the EMC information provided,and this unit can be affected by portable and mobile RF communicationsequipment.2) * Do not use a mobile phone or other devices that emit electromagneticfields, near the unit. This may result in incorrect operation of the unit.3) Caution: This unit has been thoroughly tested and inspected to assureproper performance and operation!4) * Caution: this machine should not be used adjacent to or stacked withother equipment and that if adjacent or stacked use is necessary, thismachine should be observed to verify normal operation in theconfiguration in which it will be usedWarning: changes or modifications not expressly approved by the partyresponsible for compliance could void the user’s authority to operate theequipment.Note: This equipment has been tested and found to comply with the limitsfor a Class B digital device, pursuant to Part 15 of the FCC Rules. These limitsare designed to provide reasonable protection against harmful interferencein a residential installation. This equipment generates, uses and can radiateradio frequency energy and, if not installed and used in accordance with theinstructions, may cause harmful interference to radio communications.However, there is no guarantee that interference will not occur in aparticular installation.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page10/13If this equipment does cause harmful interference to radio or televisionreception, which can be determined by turning the equipment off and on,the user is encouraged to try to correct the interference by one or more ofthe 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 towhich the receiver is connected.-- Consult the dealer or an experienced radio/TV technician for help.Should you have any inquire, pls feel free to contact me.Guidance and manufacture’s declaration – electromagnetic emissionThe eB-G-BT is intended for use in the electromagnetic environment specified below. The customer of the user of theeB-G-BT should assure that it is used in such an environment.Emission testComplianceElectromagnetic environment – guidanceRF emissionsCISPR 11Group 1The eB-G-BT use RF energy only for its internal function.Therefore, its RF emissions are very low and are notlikely to cause any interference in nearby electronicequipment.RF emissionCISPR 11Class BThe eB-G-BT is suitable for use in all establishments,including domestic establishments and those directlyconnected to the public low-voltage power supplynetwork that supplies buildings used for domesticpurposes.Guidance and manufacture’s declaration – electromagnetic immunityThe eB-G-BT is intended for use in the electromagnetic environment specified below. The customer or the user ofeB-G-BT should assure that it is used in such an environment.Immunity testIEC 60601 test levelCompliance levelElectromagnetic environment -guidanceElectrostaticdischarge (ESD)IEC 61000-4-2±6 kV contact±8 kV air±6 kV contact±8 kV airFloors should be wood, concreteor ceramic tile. If floor are coveredwith synthetic material, therelative humidity should be atleast 30%.Power frequency(50Hz/60Hz)magnetic field IEC61000-4-83 A/m3 A/mPower frequency magnetic fieldsshould be at levels characteristicof a typical location in a typicalcommercial or hospitalenvironment.NOTE UTis the a.c. mains voltage prior to application of the test level.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page11/13Guidance and manufacture’s declaration – electromagnetic immunityThe eB-G-BT is intended for use in the electromagnetic environment specified below. The customer or theuser of the eB-G-BT should assure that it is used in such an environment.ImmunitytestIEC 60601 testlevelCompliancelevelElectromagnetic environment - guidanceConducted RFIEC 61000-4-63 Vrms150 kHz to 80 MHzNot applicablePortable and mobile RF communications equipment shouldbe used no closer to any part of the eB-G-BT, includingcables, than the recommended separation distancecalculated from the equation applicable to the frequency ofthe transmitter.Recommended separation distanceWhere Pis the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer and dis the recommended separationdistance in metres (m).Field strengths from fixed RF transmitters, as determinedby an electromagnetic site survey,ashould be less than thecompliance level in each frequency range.bInterference may occur in the vicinity of equipment markedwith the following symbol:Radiated RFIEC 61000-4-33 V/m80 MHz to 2.5 GHz3 V/mNOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and landmobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallywith accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic sitesurvey should be considered. If the measured field strength in the location in which the eB-G-BT is used exceeds theapplicable RF compliance level above, the eB-G-BT should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as re-orienting or relocating the eB-G-BT.b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page12/13Recommended separation distances betweenportable and mobile RF communications equipment and the eB-G-BT .The eB-G-BT is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of the eB-G-BT can help prevent electromagnetic interference by maintaining a minimumdistance between portable and mobile RF communications equipment (transmitters) and the eB-G-BT as recommendedbelow, according to the maximum output power of the communications equipment.Rated maximum outputpower of transmitter(W)Separation distance according to frequency of transmitter(m)150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz 0.010.120.120.230.10.380.380.7311.21.22.3103.83.87.3100121223For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmetres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximumoutput power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.FCC ID: 2ADNQEBGBTThis 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 interferencereceived , including interference that may cause undesired operation.
FUDAKANG INDUSTRIALTechnical FileFile NoTCF-004-8Rev. No1Co., Ltd.8. Instruction for UseRev. Date07.09..2017Page13/13Explanation of Symbols:Symbol for batch codeSymbol for manufacturerSymbol for ‘CE”Symbol for “ENVIRONMENT PROTECTION – Waste electrical products should not bedisposed of with household waste. Please recycle where facilities exist. Check withyour local Authority or retailer for recycling advice”Symbol for “TYPE BF APPLIED PART”Symbol for “Follow operating instructions”IP22 Symbol for “the IP classification”Symbol for “ RF transmitters”Manufacturer: FUDAKANG INDUSTRIAL CO., LTDAddress:No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, Dongguan, GuangdongChina.Tel: 86-769-81098181 Fax: 86-769-81098187 Website: www.fudakang.comEC Representative: FANTRONIC COMPOSANTSAddress: Rue Jacques Laurent ZA-Sud-Est-BP11-85150 LA MOTHE ACHARD-FRANCESoftware Version V1.2Manual Version: V1.0LOT

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