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 Chapter 2 

Measuring Principle 

Chapter 

2

 

 

 
 

Measuring Principle of the MAGLUMI

®

 

Immunoassays 

 

 
 
 
 
 
 
 
 
 

2.1 TEST PROCEDURE 1-STEP ASSAY

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2.2 TEST PROCEDURE 2-STEP ASSAY

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2.3 MEASURING FUNCTION DESCRIPTION

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2.4 MEASURING PRINCIPLE

--------------------------------------------------------------------------------------------- 5

 

2.5 CALIBRATION

------------------------------------------------------------------------------------------------------------ 6

 

Operating instructions 

Page 2-1 

Содержание Maglumi 2000

Страница 1: ...MAGLUMI Chemiluminescence Analyzer Operating Instructions Shenzhen New Industries Biomedical Engineering Co Ltd...

Страница 2: ......

Страница 3: ...ALS 5 7 DANGER OF ELECTRIC SHOCK 5 7 1 ELECTRIC SHOCK CAUSED BY TOUCHING THE ANALYZER INSIDE 5 7 2 ELECTRIC SHOCK CAUSED BY IMPROPER GROUNDING 6 8 DETERIORATION OF USERS STATE OF HEALTH 6 8 1 INJURY T...

Страница 4: ...t that generates strong electric and magnetic field noises may enter the Instrument to affect the performances and functions Use the cables attached at the installation for connection between the devi...

Страница 5: ...or Users should handle keep or process the chemicals and samples following the specified regulations etc on their own responsibility following the suitable national regulations Follow the indications...

Страница 6: ...CAUTION The barcode reader is a laser beam Never look directly into thebarcode reader as this can damage the eyes When using reagents or chemicals ventilate the room well on your own responsibility If...

Страница 7: ...r concentrations exceeding the explosion limit concentration explosion can be caused When using chemicals in the laboratory such as organic solvent which are flammable and easy vaporized take care of...

Страница 8: ...efore make sure to uncap all sample tubes before the sample racks are introduced into the MAGLUMI Analyzer If a needle crash occurs the procedure defined in the Chapter Sample Station is to be followe...

Страница 9: ...the Starter Reagents can cause chemical burns when coming in direct contact to the skin Before the Starter Reagents are handled or loaded into the Analyzer the package information for the starter rea...

Страница 10: ...e potentially infectious material The waste liquids are containing potentially infectious material of the patient samples therefore these liquids are to be disposed according to the domestic requireme...

Страница 11: ...ir Information of Use 3 The Information of Use of the used Diagnostic Kits are to be followed The MAGLUMI Diagnostic System may only be used under the working conditions defined in this Operating Inst...

Страница 12: ...oading procedure in the Operating Instruction is to be followed 2 For keeping safety and correctness of the diagnostic results the described handling and never to change the analyzer is to be followed...

Страница 13: ...e to empty it in time avoiding process interruptions 9 5 Common Cautions for Wash System 1 Use only MAGLUMI System Liquid concentrate for the preparation under ambient operating conditions in containe...

Страница 14: ...of SNIBE There does no warrantee against data safety corruption exist 10 Working Conditions of MAGLUMI Analyzer Operating voltage Alternating voltage 100 120V 200 240 V Frequency 50 60 Hz Power input...

Страница 15: ...Electric Shock by Touching Inside of the Analyzer Danger of Acid Liquids Danger of Laser Burns Danger of Laser Burns additional Information Danger of potentially infectious biological material Operati...

Страница 16: ...Safety Notes Do not pool Starter Reagents Page 14 Operating instructions...

Страница 17: ...r 30 3 5 Software 31 3 6 Connecting cables 32 3 7 Consumables 33 4 Installation and Start up 4 1 4 1 Installation of the Equipment 3 4 1 1 Electrical connections of the system 3 4 1 2 Connecting suppl...

Страница 18: ...sition 52 4 5 10 Z Start position adjust 53 4 5 10 1 Adjustment of the left needle in Z Start position 54 4 5 10 2 Adjustment of the right needle in Z Start position 55 5 Operation and Structure Of Th...

Страница 19: ...Group Selection icon Delete in detail 36 7 5 Profile icon in detail 37 7 5 1 Profile Selection icon OK in detail 38 7 5 2 Profile Selection icon Add Edit Copy in detail 38 7 5 2 1 Profile Selection s...

Страница 20: ...icon Delete in detail 16 10 3 8 Daily Lab Journal icon Valid in detail 17 10 4 Control icon in detail 17 10 5 Calibrator icon in detail 19 10 5 1 Calibrators Result Journal icon View in detail 20 10...

Страница 21: ...osal 8 13 2 4 Light Check Handling 9 14 Handling Reagents 14 1 14 1 Reagent handling in overview 2 14 2 Reagent Integrals in detail 2 14 2 1 Physical Construction of the Integral 2 14 2 1 RFID Chip of...

Страница 22: ...System Warnings and messages 19 1 19 1 System warnings and messages in overview 2 19 1 1 Message Box dialog OK in detail 3 19 1 2 Message Box dialog View in detail 3 19 1 3 Message Box dialog Print i...

Страница 23: ...Chapter 1 Intended Use Chapter1 Intended Use 1 1 AUTHORIZATION 2 1 2 NOTATION 2 1 3 VERSION INFORMATION 2 Operating instructions Page 1 1...

Страница 24: ...log box Definition Name Password Inscriptions of switches are printed in bold and set in Example OK Add Entries made by the user are printed in bold and set in Example Sample volume 2 l This makes it...

Страница 25: ...ter2 Measuring Principle of the MAGLUMI Immunoassays 2 1 TEST PROCEDURE 1 STEP ASSAY 2 2 2 TEST PROCEDURE 2 STEP ASSAY 3 2 3 MEASURING FUNCTION DESCRIPTION 4 2 4 MEASURING PRINCIPLE 5 2 5 CALIBRATION...

Страница 26: ...ncubation may range depending on the assay 1 wash sequence the amount of washing for this sequence is assay dependent Most assays that are 1 step have an average incubation time of 10 minutes Fig 2 1...

Страница 27: ...on may range depending on the assay 2 wash sequences the amount of washing for each sequence is assay dependent Most assays that are 2 step have an average incubation time of 10 minutes each Fig 2 1 2...

Страница 28: ...of 420 nm The PMT is operating as an ultra fast photo counter The pulses are amplified by a rapid electronic amplifier A circuit which suppresses the PMT signal noise is also implemented in the PMT bo...

Страница 29: ...position under the injection head starter reagent 1 will be injected into the first cavity After a pump delay time of 2 5 sec the starter reagent 2 will be injected into the same cavity to start the...

Страница 30: ...g curve corresponding with the actual conditions during measurement Brief description The stored master curve is generally defined with 10 master curve base points Two calibrators with defined concent...

Страница 31: ...libration concept example For keeping safety of the diagnostic results quality control measures are to be realized such as routine controls or calibration issues which are defined in this Operating In...

Страница 32: ...Chapter 2 Measuring Principle Page 2 8 Operating instructions...

Страница 33: ...1 3 2 3 2 RFID Reader 13 3 2 4 PIPETTING SYSTEM 14 3 2 5 INCUBATOR 15 3 2 6 WASHER 16 3 2 7 MEASURING CHAMBER 17 3 2 8 PUMP SYSTEMS 18 3 2 9 STACKER 19 3 2 10 STARTER REAGENTS 22 3 2 11 SUPPLY CONNECT...

Страница 34: ...lowing components Analyzer HP PC compatible computer with a minimum of 3 serial interfaces Keyboard Mouse Touch screen monitor System operating software based on Windows application Connecting cable a...

Страница 35: ...r 8 Incubator 9 Washer transport 10 Washer lift 11 Diluters left right 12 Back transport 13 Pusher 14 Measuring chamber 15 Barcode reader 16 RFID reader 17 Waste bag 18 Starter Area Note a MAGLUMI 100...

Страница 36: ...e 66 microcycle 4 and the analyzer status Some displays that describe the analyzer status are for example Active Analyzer active Tests are being processed Halted Analyzer inactive This condition is re...

Страница 37: ...tions as well as the pipetting units are visible A sheet of Plexiglas at the front of the analyzer provides protection against injury and prevents manual intervention during the automatic process Befo...

Страница 38: ...itions Filling and operating the sample rack Ensure that you fill the sample rack correctly by placing the sample tubes upright in the sample rack The liquids to be pipetted must be free of foam and b...

Страница 39: ...table entry fields in the sample loading dialog Additional patient data can be automatically called up from a host computer or entered manually If no barcode labels are used enter the data in the edit...

Страница 40: ...ks for Reagent Integrals An integral is a plastic mold that contains all reagents required for any given assay up to 7 containers vials The first vial of each Reagent Integral contains the magnetic pa...

Страница 41: ...he Reagent Integral prepared according to the manufacturer s instructions by its handle and slide it into the selected reagent station track Insert the integral up to the limit stop A correctly insert...

Страница 42: ...is properly inserted it is recognized by the operating software and displayed in dark gray on the monitor screen The reagent data are sent to the computer and automatically displayed in entry fields...

Страница 43: ...Data length Need for check digit y n Barcode Width Barcode height Recommended width Recommended height Code128 EAN128 1 25 characters Y 0 3mm 0 8mm N A 0 33mm 10mm Code39 1 25 characters N 0 3mm 0 8mm...

Страница 44: ...als icon to open the Globals dialog 3 Press the Barcode icon to open the Barcode dialog 4 According to your type change the corresponding value of the CheckSum Note MAGLUMI 1000 didn t include the Bar...

Страница 45: ...hin 30mm the RFID Reader will beep once signifying a correct reading Then choose an unoccupied lane to insert the reagent kit into and the information will be shown on the Reagent loading dialog When...

Страница 46: ...3 2 4 1 Pipetting needles for left and right pipetting unit are identical To ensure correct aspiration the liquids to be pipetted must have no foam on the surface Clot detection The left pipetting uni...

Страница 47: ...sible for all temperature parameters of the system and thus also for the incubator temperature This icon combines two functions a Warning display with traffic light function The color of the thermomet...

Страница 48: ...e synchronized to limit immersion and contamination of the probes All dispensation and aspiration probes are mounted on a common lifting carriage Washer lift The four height positions of the probes ar...

Страница 49: ...njected into the relevant cavity of the reaction module The geometrical arrangement of the injector ensures that with the injection of starter 1 the reagent is injected against the wall of the cavity...

Страница 50: ...g the pipetting needles 3 Injection pumps for the washer 2 Injection pumps for measuring chamber injectors The second pump section is located in the rear right of the analyzer above and beside the mea...

Страница 51: ...set at right angles to the transport direction on the stationary conveyor belt A sensor detects the presence of reaction modules and immediately moves the belt to transport the reaction modules into t...

Страница 52: ...ng out of cuvette soon appears on the screen and an audible signal is heard The processing of all reaction modules currently taking place is completed The pipetting of new samples is stopped or a new...

Страница 53: ...t and 2nd Magnetic pre separation 3rd Magnetic separation and suction injection optionally twice 4th and 5th Magnetic pre separation 6th Magnetic separation and suction injection optionally twice 7th...

Страница 54: ...r reagents are light sensitive the reagent container must always be covered by the provided removable cover Fig 3 2 10 1 Starter reagent container on the right side of the analyzer Do not spill liquid...

Страница 55: ...y a system reservoir running out b Status display When the icon is pressed the dialog box Status Reservoir shows the reservoir of liquids Fig 3 2 10 2 Reservoir Status dialog box Exchanging starter re...

Страница 56: ...System Test button to fill the tubes with liquid Fig 3 2 11 1 Supply and drainage tubes for wash system liquid on the right side of the analyzer The tubes are connected to the equipment with a tube c...

Страница 57: ...When the icon is pressed the dialog box Status Reservoir shows the reservoir of liquids Fig 3 2 11 2 Reservoir Status dialog box Exchanging wash system liquid Please refer to chapter 8 for this inform...

Страница 58: ...om its holder sealed with the supplied cover and disposed of During testing the reaction modules come into contact with potentially infectious material and therefore must be disposed of appropriately...

Страница 59: ...es two functions a Warning display with traffic light function Green Waste container is 80 full Yellow Waste container is between 80 90 full Red Waste container is between 90 100 full The processing o...

Страница 60: ...electronic connections The connection to the serial interface PC system the power supply connection and the power switch are located on the left side of the analyzer Fig 3 2 13 1 Electrical and elect...

Страница 61: ...more 1G RAM or more DVD ROM Touch screen Microsoft Windows XP 1 serial interface for connection to the analyzer 1 serial interface for connection to the host computer 1 parallel or USB interface for...

Страница 62: ...finger or pen has the same function as when using the mouse Example Touching a button carries out the associated command Touching an entry field activates this entry The keyboard is used for alphanum...

Страница 63: ...Chapter 3 System description 3 5 Software Windows XP Professional Analyzer software 1 10 for control and operation of the analyzer Operating instructions Page 3 31...

Страница 64: ...cables 9 Pin RS232 Serial interface cable for PC Analyser 9 Pin RS232 Serial interface cable for PC Host computer optional Power cord for MAGLUMI Analyzer Touch screen model may vary depending on ava...

Страница 65: ...rter reagents MAGLUMI Starter Kit 630001 2 Wash system liquid MAGLUMI Wash System Liquid 630002 3 Reaction modules MAGLUMI Reaction Modules 630003 4 Reagent light check MAGLUMI Light Check 630004 5 Wa...

Страница 66: ...Chapter 3 System description Page 3 34 Operating instructions...

Страница 67: ...CTIVITY 11 4 5 COORDINATES 12 4 5 1 PREPARATION FOR COORDINATE 12 4 5 2 STEPS OF COORDINATES 14 4 5 3 REFERENCE POSITIONS ADJUST 15 4 5 3 1 Adjustment of the reference left position 15 4 5 3 2 Adjustm...

Страница 68: ...e left needle in Z Dispense position 54 4 5 9 2 Adjustment of the right needle in Z Dispense position 55 4 5 10 Z START POSITION ADJUST 56 4 5 10 1 Adjustment of the left needle in Z Start position 57...

Страница 69: ...System may only be installed and used under the working conditions temperature altitude no direct sunlight exposure and humidity defined in these Operating Instructions 4 1 1 Electrical connections o...

Страница 70: ...he receptacle marked System Liquid Sensor 6 Insert the cable connector of the waste liquid cap into the receptacle marked System Liquid Sensor 4 1 3 Connecting starter reagents MAGLUMI Starter Kit The...

Страница 71: ...mming of the following of reaction modules at the edge of the waste bag When the waste bag is full it must be removed from the holder sealed with the waste bag cover provided and disposed of according...

Страница 72: ...following steps should be completed 1 Turn on the monitor 2 Follow the Daily Maintenance Instructions found in chapter 18 the maintenance may be accomplished either at the end or beginning of the work...

Страница 73: ...onitor Wait for the PC to start this is completed when the Desktop window appears 3 Double click on the Maglumi User icon by using either the mouse or the touch screen 4 Enter the user name password i...

Страница 74: ...to values listed in the Fig 4 2 4 2 Fig 4 2 4 2 Start up Priming Table 2nd run Section Type Values Cycles Pipettor 0 Washer 0 Chamber Set A 0 Reaction modules BGW 1 LC le 1 LC ri 1 Note The System Te...

Страница 75: ...software can be accessed a user name and password must be given The user can change the software access to accept any name and password wished see Chapter 6 section 6 4 Fig 4 3 2 User login 3 Enter th...

Страница 76: ...of inactivity 4 4 1 Shutting down at the end of the work day Upon completion of the working day the following steps should be completed 1 Turn off the monitor 2 Follow the Daily Maintenance Instructi...

Страница 77: ...s 1 When the work session is finished a Rinse and fill two empty starter reagent bottles with distilled H2O preferably at 35 40 C b Replace the starter reagents bottles with the two bottles of distill...

Страница 78: ...d 10th position track 11 s 1st and 10th position and track 12 s 10th position Fill the 1st vial the position of magnetic particle of the reagent kit used to Coordinate with 200 l water while the 2nd v...

Страница 79: ...ader dialog Press Move button one reaction module will be moved to the left pipetting position Fig 3 2 1 pipetting position a Click OK to back to the Maglumi Service dialog Press Back Trans button to...

Страница 80: ...er 4 Installation and Start up 4 5 2 Steps of Coordinates Press the Coordinates button in the main menu to open the Needles Adjust dialog Fig 4 5 2 1 Needles Adjust dialog Page 4 14 Operating instruct...

Страница 81: ...n adjust value of the stepsize Set bigger stepsize firstly then press the icon to move the pipettor needle downward When the needle get close to target posision set stepsize smaller Adjust the needle...

Страница 82: ...Chapter 4 Installation and Start up After coordinates of the left needle press OK button to exit Page 4 16 Operating instructions...

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