MQ60 User manual 1 Purpose of This Manual This text is applied for MQ60 Automated Immunoassay Analyzer. Please read the user manual carefully and installation and starting-up before using the system. Copyright MQ60 Automated Immunoassay Analyzer is reserved the copyright by Beijing Hotgen BiotechCo.,Ltd (namely Hotgen Biotech) Hotgen Biotech never does any kind of warranty, including (but not limited) implied warrantyfor a special purpose mentioning application and suitability. Hotgen Biotech does not takeresponsibilities for the accidental or indirect damage resulting in mistakes or the user manual provided, actual performance and use. The user manual includes special datas which copyright law protect. All rights reserved. It isprohibited to scan, take photo, copy, print or translate into other language without companypermission. But all content in user manual can be modified without any notice. Statement The product has special application privilege, general patent right and permission right. Theproduct can’t be used in life science research and development, patient self-test, medicineresearch and development or any veterinarian, food, waters, environment experiment or utilization field. The system supportive test projects must take Hotgen designated reagent; otherwise, thesystem can’t run normally may in order or occur error. The user should take responsibilityforusing non-designated reagent (or over period reagent) or not following operation rules bringabout wrong testing result. If users do not use and maintain the instrument according tousermanual, resulting in instruments breakdown and damage, we can’t provide free service withinwarranty. Shelf life：5 years This product life time are according to our company aging and acceleration test decided. During use system, the user should doing the maintenance and repair by the user manual. After maintenance or repair, confirmed the analyzer maintain the basic safety andeffectiveness can use normally. BEIJING HOTGEN BIOTECH CO.,LTD 9th Building, No. 9 Tianfu Street, Biomedical Base,Daxing District, Beijing, P.R. China. Tel:+86-10-56528860 ; Fax:+86-10 -56528861 E-mail: [email protected] KINGSMEAD SERVICE LIMITED 19 MEZZANINE FLOOR 19-21 CRAWFORD STREET LONDON ENGLAND W1H 1PJ Tel/Fax:0044-2032399738 Email:[email protected]
MQ60 User manual 2 Content Purpose of This Manual..................................................................................................................................... 1Copyright............................................................................................................................................................1Statement...........................................................................................................................................................1Preface............................................................................................................................................................... 5Symbol and abbreviation...................................................................................................................................5Safety Information............................................................................................................................................. 7Safety Rank.................................................................................................................................................7Safe precaution information......................................................................................................................7Operator qualification....................................................................................................................... 7Installation and handling safe requirement.............................................................................................. 8Installation environment................................................................................................................... 8Handle and scrap............................................................................................................................... 8Safe operation............................................................................................................................................8Electrical appliance safety................................................................................................................. 8Machinery safety............................................................................................................................... 9Power supply voltage.........................................................................................................................9Electromagnet Interference.............................................................................................................. 9Spare parts replacement................................................................................................................. 10Specimen, reagent and wastes safe disposal.......................................................................................... 10Specimen disposal........................................................................................................................... 10Reagent application......................................................................................................................... 10Disposal of liquid overflow.............................................................................................................. 10Scrap and consumables disposal.....................................................................................................11Systematic safety mark............................................................................................................................11Introduction..................................................................................................................................................... 14Summary..................................................................................................................................................14Basic Principle..................................................................................................................................14Instrument application scope..........................................................................................................14Biocompatible performance description.........................................................................................................15Electromagnetic compatibility instructions........................................................................................15Basic function...................................................................................................................................15Storage condition.............................................................................................................................17Basic structure................................................................................................................................................. 18Control board...........................................................................................................................................18Power switch............................................................................................................................................19Status Indicator........................................................................................................................................19Systematic interface................................................................................................................................ 19Incubator modular...................................................................................................................................20Magnetic separation module.................................................................................................................. 20Test Modular............................................................................................................................................21Application of sample modular............................................................................................................... 22Systematic installation..................................................................................................................................... 23Packing and shipment..............................................................................................................................23
MQ60 User manual 3 Installation environment......................................................................................................................... 23Installation position......................................................................................................................... 24Public Requirements:.......................................................................................................................24Installation procedures............................................................................................................................24Remove package:.............................................................................................................................25Connect computer...........................................................................................................................25Other installations........................................................................................................................... 25Installation confirmation......................................................................................................................... 25Routine operation process...............................................................................................................................26Summary..................................................................................................................................................26Inspection before turning on...........................................................................................................27Starting System................................................................................................................................ 27Inspect system alarming..................................................................................................................27Reagent and consumables preparation.......................................................................................... 27Calibration and quality control........................................................................................................28Software user manual description.................................................................................................................. 29Purpose.................................................................................................................................................... 29User ID and operation authority rank..................................................................................................... 29Scope........................................................................................................................................................30System introduction.........................................................................................................................................30Main interface..........................................................................................................................................30Area illustration............................................................................................................................... 31QC management(only limit to above class B).....................................................................32Function Button............................................................................................................................... 34Operation control area.................................................................................................................... 36Progress display area....................................................................................................................... 36Experiment display area.................................................................................................................. 37Status Display Area.......................................................................................................................... 38System entry......................................................................................................................................... 38Assay management................................................................................................................................. 40Reagent Management............................................................................................................................. 42Calibration(only limit to ClassB and above authority)............................................................................ 48QC(only limited to ClassB and above authority)..................................................................................... 51Result query............................................................................................................................................. 52Test results query.............................................................................................................................52print report...................................................................................................................................... 53system setting.......................................................................................................................................... 58Analyzer setting............................................................................................................................... 58edit report information....................................................................................................................59reagents setting............................................................................................................................... 60operator behavior configuration..................................................................................................... 60communication setting....................................................................................................................62System management............................................................................................................................... 63User management........................................................................................................................... 63log management..............................................................................................................................64
MQ60 User manual 4 analyzer information........................................................................................................................66system maintenance................................................................................................................................67resource debugging......................................................................................................................... 67function debugging..........................................................................................................................68data export.......................................................................................................................................72System explanation..................................................................................................................................... 72Experiment preparation and some basic operation............................................................................... 72system main interface......................................................................................................................72before connecting power................................................................................................................ 72logging in system and initialization................................................................................................. 73add user........................................................................................................................................... 75add reagents information................................................................................................................75General sample experiment.................................................................................................................... 78select test line and edit sample information.................................................................................. 78instrument and specimen preparation........................................................................................... 83Start test and test finished.............................................................................................................. 87Calibration test.........................................................................................................................................88Calibration purpose......................................................................................................................... 88About calibration............................................................................................................................. 88Check calibration status...................................................................................................................89select line and edit calibration information.................................................................................... 91Start test and test finished.............................................................................................................. 99QC Products Test....................................................................................................................................101Introduction................................................................................................................................... 101Quality Control purpose................................................................................................................ 101About QC experiment....................................................................................................................101Select lane and edit QC information............................................................................................. 101Instrument and QC reagents preparation..................................................................................... 105Start test and test finished............................................................................................................ 109
MQ60 User manual 5 Preface MQ60 Automated Immunoassay Analyzer, matched multi-type immune test project, whichcanfinish qualitative and quantitative IDV and analyze. The system is a diagnostic experiment automatic tool with complete function. User can take use of people and machineinter-operation interface to process routine test and daily maintenance conveniently. The manual describe carefully the MQ60 usage, systematic module, safe information, operation method, emergency situation program, product sticker classification. Pleasereadthe text carefully first, then to operate. Please follow the operator manual instruction and indication, make sure systemruns withsafety. If use the system not following the regulation in the operation manual, it will influencethesystematic function and safety security. Please keep the user manual in safe place and make sure not to be damaged. The operation manual should put at convenient place, easy to get and use at any time. Symbol and abbreviation The user manual adopts below symbol and mark which can instruct different risks andattention, etc. Usage Attention！ The content of symbol warning is not related to product safety, but it will influence the correction of checking result, system stable working, system lifetime etc. Warning！ The symbol warning is related to the product safety and relevant content. Operate it not following the regulations, it is possible to bring about safety hazard Biology danger！ The content of symbol warning is related to the biology hazard. It will bring environment pollution or operator health hazard if do not operate as regulations.
MQ60 User manual 6 The text use below abbreviation words. Abbreviation Meaning Hotgen Biotech Beijing Hotgen Biotech Co.,Ltd MQ60 Automated Immunoassay Analyzer
MQ60 User manual 7 Safety Information Safety Rank The text warning safe information includes below three kinds safe rank. Biology Hazard Medical wastes and possible biology hazard. If do not operate it as requirements, it is possible to lead to people death, severe damage, medical waste leaking etc. Warning Warning possible dangerous situation, if do not operate as requirements, it is possible to make the device damage, wrong test result or harm to people. Attention Warn about how to use the system rightly and make sure the test result accurateetc relevant information avoiding user wrong operation. It will influence the test result or short device lifetime. Safe precaution information Below safe precaution information is used to ensure user safety, test result effectiveanddevice safe usage. User must read below content carefully before using the system. If ignoringsafe precaution warning information, operator will suffer from server harmpossibly. Operator qualification Mis-operation will result in testing result error or analyzer device damage. Operator should learn relevant knowledge about clinical test and principle of chemical luminescent test. Operator has to be trained by Hotgen Biotech Company before operator runs the system. Operator should follow the relevant regulations in the user manual strictly inthe systematic operation and routine maintenance. When the devices occur to breakdown or problem that never mentionedinthe user manual, operator should contact Hotgen Biology company after-saleservice staff. Follow clinical test relevant regulation, handle device discharged waste liquidand used consumables.
MQ60 User manual 8 Installation and handling safe requirement Installation environment Environmental humidity, temperature and cleaning do not accord withrequirements, which will lead to test result inaccurate or systemdamage. Handle and scrap The system touch the body blood directly, so it should be sterilized as countryregulation. The system touch body blood directly, so it belongs to potential medical dangerous products. It should be sterilized strictly before move or re-use andscrap. It should operate as national relevant regulation, specially scrap thedevice. Safe operation Electrical appliance safety General requirements Please check below safe items, in order to avoid staff injured and prevent theproducts which other products connecting again damage. In order to avoid potential danger, please operate the products as the user manual strictly. GB4793.1-2007/IEC61010-1:2001standard The device design and test conform to GB4793.1-2007/IEC61010-1:2001 standard In order to use the device rightly and with safety, please read carefully andfollow user manual listed all notice, relevant instruction and warnings strictly. Avoid lightening stroke，fires and personal injury Under the circumstance of un-specified in the user manual, operator can’t get off any device mask without permission even not touch interior power, circuit, wire, etc with electricity. Use suitable power cable, just use the designated product and get thenational certificated power cable. Use right power voltage, please make sure device used standard regulatedpower voltage before power on. Product grounding. The product realizes ground earth through power cablelanding. In order to avoid touching electricity, ground cable must ground
MQ60 User manual 9 connection of land. Before using it, make sure the products have groundedon earth. Under the suspect circumstance of breakdown, Please do not make anyoperation. If you suspect products has something wrong, please contact designated warranty staff for checking. Please only user Hotgen Biotech designated fuse type and rated value. Please keep product surface clean and dry Please use the instrument as the user manual strictly, otherwise, instrument protection function or product performance is possibly weakened、lower or invalid. Please do not use the instrument in humidity environment (environment humidity over 70%). Machinery safety Caution moving parts and mechanism harm to people Operator prohibit closing all moving parts in the systematic operation, specially spotting module，incubating module etc directly touch specimenor reagent dangerous assembly parts. Otherwise, it will harmoperator bodypossibly. In the systematic operation, operator can’t put your finger or other belongs into spotting module, incubating module, separating module etc. sports parts interior harm people safety or result in instrument damaged. Under the unspecified circumstance, operator can’t get off any instrument mask without permission; avoid being scrapped by sharp spare parts instrument interior. System is in the process of operation; please make sure the protection maskin the close status. When operators use the system, they should wear gloves. Power supply voltage The power supply is not stable, which lead to device can’t run in order or damage. The power supply voltage is not stable, which leads to systemhardwaredamage Electromagnet Interference Electromagnet interference influences equipment normal work Systematic photoelectricity testing device is very sensitive to theelectromagnet interference. In order to avoid magnetic equipment influence systematic electronequipment, try to avoid using following equipment: mobile phone, radio
MQ60 User manual 10 equipment, cordless telephone and other equipment which bringelectromagnetic radiation or magnetic field Please use shield port cable provided Hotgen Biology, in order not toinfluence device breakdown resulted in electromagnetic interferencepossibly. Spare parts replacement Use not certified or qualified spare parts will bring device breakdown or test error When the spare parts damaged or become due and need to change, pleasecontact Hotgen Biotech company after-sale staff. User can’t change it bythemselves or even user not-certified spare parts. Otherwise, free warrantyservice will be invalided. Specimen, reagent and wastes safe disposal Specimen disposal Contamination or layering of samples will result in errors or pins Specimen should process centrifugation before testing in the instrument, make sure there is no bubble, coagula and pollutant in the liquidsupernatant. Specimen should not explore in air for long time, avoid concentrationdeviation for vaporizing. The smallest specimen volume is not less 100uL. Reagent application It is harmful that body touch the reagent directly. Operator need to wear gloves avoiding direct touch the reagent whenoperate it. If do not use the reagent long time, please put them in refrigerator. Before putting reagent cassette in front of incubator module, please make sure bar code is clear, no water drop coagulation Disposal of liquid overflow Biology dangerous liquid pollution Specimen touching body will lead to infection; all the consumables andsystematic spare parts relevant body specimen are in danger. Liquid spoil instrument surface and interior, which has the risk in resulting in
MQ60 User manual 11 instruments breakdown. If specimen touches skin, please wash and sterilize at once. Scrap and consumables disposal Waste liquid and consumable infection It is easily infectious to touch the waste liquid or used consumables discharged from instrument. Operator must wear protecting equipment and gloves, avoid gloves beingscratched leads to body infection during work. Waste liquid and consumables should be handled as infectious medical usage junk as national relevant regulations. Systematic safety mark In order to ensure users’ safety and system stable operation, it sticks to warning mark intherelevant position on the equipment. Detailed position and meaning as follows. Systematic safety mark follows IEC60601 standard Caution scratch The mark hints there is sharp machinery parts, harm to user. Please operate withcaution Biology dangerous warning The mark warns there is biology danger at near area; user should operate as safety procedures. Attention High-temperature The mark hints that there is heating equipment in the near area, danger to burn. Above safe mark position refers to logo Graph 1, logo Graph 2, logo Graph 3,and logo Graph4.
MQ60 User manual 12 Graph 1 Caution spotting module stabbing finger. Graph2
MQ60 User manual 13 Graph 3 caution specimen biology harm, should wear gloves during operation. Graph 4 Attention to high temperature
MQ60 User manual 14 Introduction The chapter carefully introduce Hotgen Biotech system each module function, workingoperation regulation etc. Summary Basic Principle Chemiluminescent immunoassay technology is the combination of chemiluminescent material andimmunity reaction, using light reaction manifest tested immune ingredient concentration, namelycombine high-sensitive light reaction and specificity immunology reaction. Chemiluminescent magnetic enzyme immunology is a kind of new analyzed method which combineschemiluminescent analyzed method, magnetic separation technology and enzyme immunity analysismeanings. It take use of high-sensitivity of chemiluminescent analyzed method, magnetic separationmethod, swiftness of magnetic separation method, easy automation and immunity analysis methodsteep specificity etc. characters. It has wide application prosperity during clinical immunity test. The system adopts magnetic particles as vector chemiluminescent immunoassay technology. Throughtesting the detected (Antigen, Antibody) catalyzing substance luminescent intensity, counting onthetested concentration. All test process gets through below few procedures: Auto adding specimen, take disposable head absorbing specimen, makes sure zero carrying pollution. Automatic adding reagent: according to different testing process, automatically finish one or tworeagent addition, mixture. Warm bath reaction: during warm bath, mix the reaction liquid. Magnetic bead automatically washes 3 times, washing out reaction liquid and left magnetic beadparticle and combines determinant. Auto adding substance and mix Test luminescence value Instrument application scope Hotgen Biotech MQ60 is an instrument which is used in clinical immunoassay, using together withmatched immunoassay reagent cassette. It makes qualitative and quantitative immunoassayforserum, plasma and whole blood. The system is only used to test qualitative and quantitative detection by human serum, plasmaandwhole blood as clinical diagnosis reference. The final diagnosis result need doctor making decision. The system expected operator is qualified as IVD common knowledge staff, who must be trainedstrictly before operate instrument. Systematic installation, maintenance and software updating, isfinished by designated customer service staff by Hotgen Biotech.
MQ60 User manual 15 Biocompatible performance description The operator will touch the door in a short time during operation,, the door is made of plexiglass, andthe operator needs to wear protective clothing and medical rubber gloves according totheinstruction manual. The instrument does not have biocompatibility to the operator. Its safetyandeffectiveness have been verified by testing, so the machine will not have adverse effects onthehuman body. Biocompatibility refers to a property produced by living tissue on non-reactive materials. Generallyrefers to the compatibility between the material and the host, including histocompatibility andhemocompatibility. Biocompatibility does not cause adverse reactions such as tissue, blood, andsoon. One of the most basic contents of biocompatibility evaluation is biosafety. Biosafety refers tothefact that the interaction between material and human body must be non-toxic to the human body, noallergenicity, no irritation, no genotoxicity, no carcinogenicity , No adverse reactions to humantissue, blood, and immune system. MQ60 automatic immunoassay analyzer is mainly for the detection of human blood samples of theprocess, the operator with the basic knowledge of basic in vitro diagnosis, in the operationof equipment, need to undergo a rigorous training, not in direct contact with patients, so it will not influences human body. It is noted. Electromagnetic compatibility instructions a) This equipment complies with the emission and immunity requirements specified in GB / T 18268.1andGB / T 18268.26. b) It is recommended that the electromagnetic environment be evaluated before the equipment is used. c) Do not use this equipment with a strong radiation source, such as a non-shielded RF source, as this mayinterfere with proper operation of the equipment. Basic function Hotgen Biotech MQ60 basic function sees table1-1 Table1-1Basic function index Degree of automation Automation Sampling material human serum, plasma, and whole blood, UrIne and Cerebrospinal fluidSize 380mm×600mm×600mm (length*width*height) Weight 40.0kg Wavelength 340nm～650nm Dynamic scope 1 S－1 ~ 10 7 S－1
MQ60 User manual 16 Reagent slot SIX (single dos) Specimen slot SIX( batch mode) Test Flux 20 T/ hour Computer CPU：CPU: basic frequency above 1.7GHz Memory: over 512MB Hard disk: over 40GB Operation system: Windows7 or Windows 10 Normal working condition 10℃～30℃ Environment Temperature ≤70% Relevant humility ≤2000m Altitude: ≤2000m 85.0kPa～106.0 kPa Atmospheric pressure Far away from strong magnetic field interference source Avoid strong magnetic field inference source Well electrical grounding environment EI.requirements Voltage: exchange 220V±22V Frequency: 50Hz±1Hz Power: 400VA Warm up time no less than 30 minutes Background counting rate Test luminescence value of empty reaction tube less than 100 RLULinear relativity Not less than 2 pieces quantitative concentration scope, linear relativity （r）≥0.99 Intra-assay testing repeatability Coefficient of variation （CV，%）≤8% Stability The relevant bias is not more than ±10% between after MQ60 poweringoninstability working status the fourth hour, the eighth hour testing result andstable working status initiating test result. Incubating module temperature controlling Temperature Stability：37℃ ± 0.5℃ Temperature fluctuation: less than 1℃ Spotting accuracy and repeatability Test for instrument specimen 50 μL, spotting accuracy difference is less than8%, Coefficient of variation is less than 5% Function User can make instrument automatically finish different specimentestprogram analyzing task. Instrument automatically reagent etc. consumables; the status of waste. Instrument is equipped with self-test function Breakdown indications: Instrument should indicate for the operationmistake, machinery and electrical circuit breakdown. Software version 1.0.2.2
MQ60 User manual 17 Storage condition Packed MQ60 should keep at temperature -10℃~55℃, relevant humility is not over 93%, no corrosiongas and well ventilated room.
MQ60 User manual 18 Basic structure MQ60 is consisting of main unit (incubator module, spotting module, magnetic separation module, testinglight module, electrical appliance control module) and computer. Graph 5 Instrument front view Control board Control board is consisting of computer, hand held bar code scanner, data connecting line. Accordingto user requirements, can match printer connect computer. Control board used as test program and process operation setting. System running control andmonitor, display system running status, storage test data(specimen, calibration product, qualitycontrol product), system routine report, system parameter setting etc. Status indicator and button Device protectionmask
MQ60 User manual 19 Power switch The function of systematic power switches (Ship-shaped switch lies at left side of instrument): Power switch is controlling total inbound of power on and off as switchboardpower switch. Status Indicator Status indicator(Graph 6）lies in front of instrument, as indicating instrument status: Green light: Instrument are in the process of program test or initiating at present Red light: Instrument breakdown alarm Graph 6 status indicator Systematic interface System realizes PC main unit communication with instrument controlling systemthroughUSBPort. Graph 6 systematic interface, power socket, and general power switch. Graph 7 system interface, power inlet connector, general power switch
MQ60 User manual 20 Incubator modular Incubator modular sees Graph 8 incubator modular. It is a rack area which can put reagent strip and equipped with incubation function at the same time. Graph8 incubator modular Put reagent strip rack At the putting reagent strip area, user can put 6 pieces reagent strip one time, can’t put any newreagent strip during instrument working. After user add new reagent strip, should press Start button at instrument front panel or click “start button” at software operation interface Take away tested reagent strip rack After test being finished, the finished reagent strip rack will exit automatically. Tested reagent strip rack will enter reagent rack zone. Magnetic separation module Magnetic module see Graph 9, reaction intermixture realizes magnet particle wash at magnet separation module. Knock out the reaction liquid of warm bath reaction. Only left washedmagnetic particles. Magnet separation modules can realize three class wash, throughthreetimes follows “magnet adsorb, knock out reaction liquid (or wash liquid), addition to washingliquid, blending” process, finish the effective washing to magnetic particles. Put reagent strip rack and Take away tested reagent strip rack
MQ60 User manual 21 Graph 9 Magnetic separation modular Test Modular Test modular see Graph 10 Test Modular, Test modular is to test luminescence value test andquantitatively or qualitatively test specimen concentration. Graph 10 Test Modular There is permanent magnet in magnet separation module, please avoid electrical appliance closing the area to damage the equipments.
MQ60 User manual 22 Application of sample modular Test modular see Graph 11 Application of sample modular. Application modular is usedforliquor relief of each reagent constituent when reacting. Graph 11 Application sample There is high-precise test equipment in the test area. User should avoid electrical magnet interference closing the area in case of luminescence value mistake. There is high-precise injector in the test area. User should avoid sharp sparepartsclosing the area in case of scraping injector resulting in application sample inaccurate. SyringeUnit
MQ60 User manual 23 Systematic installation Packing and shipment Please check whether the instrument package damage or not carefully during transportation. If damaged, please make a statement at once. After instrument devanning, Please check whether instrument appearance is perfect or not. If there is carrying damage, please make a statement at once. Please check packing list and confirm spare parts complete, perfect. If you find configurationis not complete, please contact Hotgen Biology sales department or designated agent. Shipment environment: Temperature: -10 °C ~ 55 °C。 Humidity: ≤93% MQ60 systematic devanning, installation need to be done by designated or qualifiedtechnician from Hotgen Bio-tech. Before installation, users need toprovideoperation environment meeting application requirement. Installation environment MQ60 system is only suitable for use indoor. Detailed installation environment requirement asfollows: Floor flat and have enough intensity, there is no machinery vibration around surroundingenvironment. Well ventilation indoor, make sure energy which instrument interior electrical appliancegenerates gives off in time. Clean air and no dust indoor. No corrosive and flammable gas. Clean class reach national clinical test room environment standard. Avoid sunshine straightaway shot, avoid putting air conditioning etc. hot windsourcenearby. There is no noise interference electrical interference Install position should be far away electrical magnet field interference source, includingcentrifuge, recharging equipment and mobile telephone. Temperature: 10-30℃. If the temperature is higher than 37℃nearby incubation modular, otherwise it will bring warm bath temperature mistake, which influences test result. Temperature fluctuation is less 2℃/hour during experiment. Relevant humidity: ≤70% Altitude: ≤2000 meters Desk top(Angel: <1/200), Desk top is hard enough and can bear instrument weight
MQ60 User manual 24 No violent vibration using Power requirements: There should be independent, reliable earth wire in the Installation room System can’t share the same circuit with power consumption equipment of high power Voltage: AC 220V±22V Frequency: 50Hz±1Hz User should contact Hotgen Biology after-service department before operatinginstrument carrying, spare parts exchange, software update etc. Installation position System installation position sketch map (Graph12) Graph 12 System installation position sketch map(unit: mm) Public Requirements: Main power voltage: AC 220V±22V Frequency: 50Hz±1Hz Installation procedures. MQ60 system installation need to be operated by Hotgen Biotech designated after-sale servicestaff. User can’t remove package without permission.
MQ60 User manual 25 Remove package: After receiving MQ60, please inspect the instrument package carefully, whether it is damagedor not. If so, please contact Hotgen Biology or local agent. Please make sure there is noanypackage damage circumstances, Hotgen designated after-sale service staff remove packageasbelow procedures: Please make sure position arrow upward stand upright in the package box. Remove package box; Open main unit box, accessories box, please check packing list, if there is any lost, pleasenotify after-sale service staff at once. Please inspect the instrument, computer and accessory etc. look, if any damage, pleasenotify after-sale service staff at once. Connect computer Please connect portable communication cable one end with “USB” on the analyzer left backward mask board; the other end connects with “USB” at computer main unit. Please insert Hand held barcode scanner USB into any USB of computer. Users connect computer with printer as their own requirements, which can be used toprint test report. Printer installation please refers to printer installation manual. Other installations Software installation had been finished before ex-factory. Systematic initiatively power oncanenter software operation interface. Installation confirmation After MQ60 installation being finished, as routine operation process of power on inspection procedure, it can confirm the installation effectiveness. Cleaning and disinfection Users can regularly clean the MQ60 countertops and panels with clean water or 75%ethanol. If hazardous substances are leaked on the surface of the equipment or into the equipment, 75% ethanol or disinfectant should be used for sterilization. If you have questions about thecompatibility of the disinfectant or cleaning agent with the material contained in theequipment or equipment, you should consult the manufacturer or its agent.
MQ60 User manual 26 Routine operation process Summary Routine operation includes which preparation system, analyzing specimen when needroutinetask. System summarized circuit graph gives operator intuitive guideline of routine operation. Below sketch map 4-1 provide routine operation general situation. Graph 13systematic routine operation flow chart
MQ60 User manual 27 Inspection before turning on Before starting system, must inspect systematic following status. If the status is not coincidence with the below listed. Control Unit Confirm computer has been connected rightly; Confirm handheld barcode scanner has connected with computer USB. Connect printing system, user need to check whether paper is enough or not MQ60 system Before user turning on to operate, should check whether below segments prepared well or not one by one Consumables waste box delete and put in right position There is no waste reagent strip in reagent trip transmission area All surface is clean and no disordered articles. All tube lines are not be clipped or curve. Starting System Start MQ60 power switch Start computer, wait MQ60 software to start automatically; System carrying on initiating maintenance automatically After initiating successfully, system enters in order. Inspect system alarming If system makes alarm, in this situation, look up “alarm” window and check alarmrelevant content. “Alarm” window indicates the alarm status in the system. It need exclude dysfunctionand delete alarm status, system will enter standby status normally; otherwise, the systemwill last alarm. Reagent and consumables preparation （1）Put reagent strip The reagent strips to be used are placed outside the machine and placed on the reagent rack, adding no less than 100uL of sample to the sample wells. The use of reagents, storage must bestrictly in accordance with the reagent instructions, do not make the reagent bubble. Reagent shaking will produce foam, affecting the accuracy of pipetting, resulting in the amount of fluidis not allowed. When Users add the sample to the reagent, the sample should be carefully observedonthe surface, if there is a clear bubble, should use a clean Pipette to suck out the liquid bubble. （2）The rack of putting reagent strip Lay out the reagent rack which is put reagent strip on the incubator modular, make sure reagent strip rack puts inside complete while putting and no space.
MQ60 User manual 28 （3）put consumables( disposable sample head) After putting reagent rack, observe reagent strip used channel, putting disposable sample headandmake sure disposable sample head match reagent strip. Calibration and quality control While applying MQ60 system, it is necessary to calibrate and test QC samples to all test andmake sure reagent and whole system stability. Before starting routine operation, pleasemakesure to finish calibration process successfully and all quality control test result is normal. It is different between all kinds of test tasks required calibration and QC space time. User should execute calibration and direct operation as designated cycle strictly as user manual’srequirements in cassette. If the application environment is different, user can increasecalibration and QC frequency as requirements or start calibration as QC result Load required calibrator and controls 1. Please prepare for calibrator and controls as its content and manufacturers’ relevant usermanual, add 100uL at least to reagent strip. Input calibration rack No. and relevant position information in the software interface.(refer to “software user manual) Before adding calibrator and Controls to reagent strip, please inspect and confirmthereis noair bubble and foam on the face of liquid. 2. Please load calibrator, controls and reagents on incubator modular, launch the start button. Because calibrator or controls expired bring out incorrect result 。It is not reliable to use overdue calibrator or Controls test to get result. Please do not useoverdue calibrator or Controls. Test calibrator and controls Click “start” button at software operation interface, start testing process. Calibrationandquality controlling test usually start before regular operation, namely process before start totest sample. But, it can be done at any time during routine operation process.
MQ60 User manual 29 Software user manual description Purpose The user manual includes the information: user must learn knowledge before operatingtheinstruments. It is very important to test before user applying the instruments; so user shouldbe familiar with these information ahead of time. User ID and operation authority rank Menu Interface display Function Operation Authority RankC B ATest setting Experiment management General Sample test patients specimen ＸＸＸCalibration sample test calibration ＸＸＸQC sample test QC specimen ＸＸＸReagent management Basic information display reagent basic information ＸＸＸStandard curve standard curve ＸＸＸStandard curve parameter information ——ＸCalibration management calibration experiment result —ＸＸcalibration management —ＸＸQC management QC management dialogues shows QC information —ＸＸTest result query Test result query Test result query page query test result ＸＸＸCalibration result query Calibration result query page query and confirmation result ＸＸＸQC result query QC result query page Query QC result ＸＸＸSystem setting machine setting instruments setting diaglogues setting system language variety ＸＸＸReport information edit ＸＸＸreagent setting ＸＸＸuser action setting ＸＸＸcommunicati on setting Communication setting dialogues CAN communication setting ＸＸＸSerial configuration ＸＸＸSystem User User add/delete user ——Ｘ
MQ60 User manual 30 manag ement management management dialogue information Routine report management Routine report management dialogue check system,user and wrong routine report ——Ｘequipment information equipment information dialogues check present equipment —ＸＸSystem mainte nance resource adjustment Resource adjustment dialogues make an adjustment to each source of equipment ——Ｘfunction adjustment Function adjustment dialogues make a single adjustment to each function unit ——ＸData export Data export dialogues export data —ＸＸMark: Permission X; no permission - Scope The text describes the application method of software system which operates MQ60liquidphase automatic chemiluminescence immunoassay analyzer. It is suitable to applyfor experiments test people, after-sale servicer and adjusted engineers. All displayed software graph only to illustrate in the chapter of the user manual. Wedonot make sure all these software illustration is correct result. System introduction Main interface Below graph is the main interface of MQ60 liquid phase automatic chemiluminescence immunoassayanalyzer system software. As an independent main interface, it is used to control MQ60 liquidphaseautomatic chemiluminescence immunoassay analyzer. It provides the whole process of monitoringfunction from specimen scanning, specimen test and test report print etc. At the same time, for it is moreconvenient for system examination and reparation and configuration; the system also provide all kindparts test and calibration function. For user application, the system mainly provide below function: Patient specimen test; Calibration
MQ60 User manual 31 Reagent management Result query Systematic management and maintenance Graph 14 Main Interface Area illustration 1 Area: menu area, include” test setting”, “result query”, “systemsetting”, “systemmanagement” etc. 2 Area: function button, namely shortcut button area, one key can realize relevant functionthrough clicking button, including: “reagent management”, “query result”, “systemsetting”, “user management”, function adjustment’. 3 area: operation control area, which is used to control instruments, make routine test anddysfunction restart. 4 area: status display area, which shows present system time, present entry user andexperiment progress. 5 area: experiment display area: it shows 6 accesses experiments information and makeanexperiments configuration through double click some access. 6 area: Status display area: the area displays present incubator and separation modulartemperature and present system will provide information hint as systemoccurs tomistake. Graph 15 Menu
MQ60 User manual 32 Test setting Mainly includes relevant function display with experiment, namely: experiment management, reagent management and QC management. Experiments management 16 Menu [Experiment Management] Detailed requirements see experiment management Reagent management Graph 17 Reagent management [Menu] Detailed requirements see reagent management QC management(only limit to above class B) Graph 18 QC management Detailed requirements see QC (only limit to authority to above Class B) Result query Main all kind of information query and search, including test result query, calibration result query, QCresult query, patient information query. Test result query Graph 19 test result query [Menu] Detailed requirements see results query. Calibration Result query Graph 20 Calibration result query[Menu] Detailed requirements result query
MQ60 User manual 33 QC result query Graph 21 QC result query Detailed requirements result query System setting Instrument setting Graph 22 instrument setting [setting] Detailed requirements see system setting Communication setting Graph23 communication setting [setting] Detailed requirements see system setting. System management (only limit to authority Class B or above B) Include user management, Routine reports checking and equipment version information. User management (only limit to authority Class A) Graph 24 User management [menu] Detailed requirements see system management Routine report management(only limit to authority Class A) Graph25 Routine report management [menu] Detailed requirements see system management Equipment information(only limit to authority Class B or above Class B)Graph 26 Equipment information [Menu] Detailed requirements see system management System maintenance (ClassB and above only)
MQ60 User manual 34 Including resource debugging, function debugging and data export information. Resource debugging (only limit to ClassA ) Graph 27 Resource debugging (menu) See the specific requirements for system maintenance. Function debugging ( only limit to Class A) Graph 28 Function debugging (menu) See the specific requirements for system maintenance. Data export (only limit to Class B or above) Graph 29 Data export (menu) See the specific requirements for system maintenance. Exit Exit system Graph 30 Exit (menu) Function Button Graph 31 function button
MQ60 User manual 35 Reagent management Graph 32 Reagent management [shortcut] Detailed requirements see reagent management Query result Graph 33 query result [shortcut] Detailed requirements see result query Instrument setting Graph 34 Instrument setting[shortcut] Detailed requirements see system management User management Graph 35 User management[shortcut] Detailed requirements see system management maintenance Graph 36Maintenance[shortcut] Detailed requirements see system management
MQ60 User manual 36 Operation control area Graph 37 Operation control Start Button Graph 38 Start button After present user sets relevant channel experiment details, clicking the button and starting experiment process “Stop” button Graph 39 Stop Button The user can stop present process through the button at any time during experiment process. “Re-start” Button Graph 40 Re-start button When current users click stop button or system occurs to mistake, “start” button can’t use. Click re-start button and wait system initialization finished, all kind of experiments are accessible. Progress display area. Graph 41 Progress display System time Graph 42 System time
MQ60 User manual 37 It shows current system date and time Current user Graph 43 current user Show current login system user name Experiment progress Graph 44 Experiment progress During experiments, the figure will increase gradually as experiments are in gradually enlarged process, tocomplete. Experiment display area Graph 45 Experiment Display There are total six accesses at experiment exhibition. It is coincidence with instrumentsexperiments condition. It is the same with exhibited content type at each access. Graph 46 Access 1 content exemplify. Graph 46 access 1, content example shows single access content, includes: programabbreviation, reagent a lot. Sample type and characters, SID and concentration value.
MQ60 User manual 38 Status Display Area Temperature T Temperature L bin gate alarm information Graph 47 Status display Temp.T： Temperature T: Incubator temperature Temp.L： Temperature L: magnetic separation temperature Alarm information System entry Graph 48 System entry User name: first open windows are last user name entering successfully. When thereis amistake to input user name, system will hint as below: Graph 49 Please input correct user name
MQ60 User manual 39 After clicking “confirm” button, “user name” will be deleted, input focus will centralize here. As belowgraph:50 Graph 50 deleted user name input frame Password input: After user inputs right password, you can enter system. If input wrongword, system will hint as below: Graph 51Please input correct password After clicking” confirm”, password input is deleted automatically. Exit: while clicking “exit”, system will not enter
MQ60 User manual 40 Assay management Access choice Graph 52 Assay management Access No.: choose to take use of some access do relevant experiments “Delete” button can delete present chosen channel project information; noproject information, conceal. Click the third channel in the main interface, which can import channel signal. As Graph53 select access 1.
MQ60 User manual 41 Graph 53 Choose access1 project choose project: project information will be record through system scan reagent barcode specimen information input: Specimen character: divided into general demo/standards/calibrations Specimen type: serum/plasma/whole blood/urine SID: User input patients ID through handheld scan gun or manual entry. Dilution factor: In the situation of demo dilution disposal, the result concentrationwill be adjusted accordingly. The check doctor: you can first "instrument set" "report information editor" toadd, inthe experimental management interface the check physician drop box selection. Click
MQ60 User manual 42 Reagent Management Reagent choice Graph 54 Reagent Management Reagent list: can display English abbreviation of all system known reagent variety. Batch display: shows all applicable batch information of present chosen reagent variety, including batch, effective date information. If you click the "Back" button, the system will enter the reagent information displayedinthe experimental management interface. Reagent basic information; Basic information folio: includes some reagent basic information, below“referencevalue management” shows normal value scope of quantitative reagent. Standard curve folio: shows all curve information under batch, including standardcurveand correct curve; Calibration management folio: The current batch number under the relevant curve calibration, ClassB and abovecanview Reference management Reference management Show present reagent reference scope. edit button:
MQ60 User manual 43 Click” edit” button, can entre below window as graph 51 reference value changeandedit to reference value. Graph55 Reference value change Reference value display Display present reagent records reference value add to reference value Through inputting relevant reference value, click adding button and can add. After finish inputting, click confirm and save. Note Name can’t repeat. Revise reference value After choosing reference value, can revise relevant content. After finish inputting, click confirm and save Cancel Can make converse operation to “add” and “revise” function Return Click the button, will return “reagent management” interface.
MQ60 User manual 44 Graph56 Reagent Management(No standard curve) Standard curve: Switch “standard curve” page through TAB page. There is no any data at Initial situation; for example 56 reagent management (nostandard curve) Through choice of reagent and relevant batch, it can show standard curve, as 52reagent management (no standard curve) shows. o Illustration Standard curve shows standard curve and relevant standard dot o Basic information Includes each parameter and standard dot information of curve, as 58 graph reagent management（standard dot）(only Class A can be checked)
MQ60 User manual 45 Graph 57 reagent management(standard curve) Graph 58 reagent management(Curve parameters)
MQ60 User manual 46 Calibration management Access label page can switch to “calibration management”, as Graph 59 reagent management(calibration management) Curve choice. Can choose relevant curve under present reagent batch and correct it. Present curve under batch lies data which can be calibrated, “calibration experiment result”will indicate calibration button. Click Calibtion button, which can calibratepresent curve. It will occur to new curve after calibration instead of original standardcurve or calibration curve. After reagent information is input system, it will shows in “calibration management”asgraph 60 reagent management (calibration management) Graph59 Reagent management (calibration management)
MQ60 User manual 47 Graph 60 Reagent Management(calibration management) Reagent addition Addition button, can add reagent information and relevant batch information(ClassCand above can add to reagent information through scan) as graph 61 reagent addition.
MQ60 User manual 48 Graph61 Reagent addition Calibration(only limit to ClassB and above authority) set calibration information for relevant access; Choose access 1 at main interface, double click to enter reagent management, choose“calibration products” at the specimen character column, as graph 62 experiment management(calibration products), after finishing choice, click to choosereagent.
MQ60 User manual 49 Graph 62 Experiment management (calibration) choose calibration type. In the select of “calibration”, choose Cal1/Cal2, as graph 63 experiment management (calibrationexperiment) shows. After clicking” confirm” button, namely as below 64 main interface calibrationsettingshows.