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UNION Immune Analyzer

Operation Manual

Released Software V2.3.0

SHENZHEN YHLO BIOTECH CO., LTD

No.5 Building, Lishan Industrial Area, Xinghai Road, Nanshan District

518054 Shenzhen, P.R.China

Tel : +86-755-26473359

Fax: +86-755-26473319

Web:

www.szyhlo.com

Содержание UNION

Страница 1: ...Operation Manual Released Software V2 3 0 SHENZHEN YHLO BIOTECH CO LTD No 5 Building Lishan Industrial Area Xinghai Road Nanshan District 518054 Shenzhen P R China Tel 86 755 26473359 Fax 86 755 26473...

Страница 2: ......

Страница 3: ...18057 Shenzhen P R China Production Address No 5 Building Lishan Industrial Area Xinghai Road Nanshan District 518054 Shenzhen P R China Website www szyhlo com E mail Address service szyhlo com Tel 86...

Страница 4: ...ility and performance of this product only if a All installation operations expansions changes modifications and repairs of this product are conducted by YHLO authorized personnel b The electrical ins...

Страница 5: ...d earthquake d Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people e Malfunction of the instrument or part whose serial number is not legible eno...

Страница 6: ...d consumables manufactured by YHLO Any use of generic products may lead to increased risk or measurement errors for which the user assumes complete responsibility Any modification of the software and...

Страница 7: ...ded and should be connected to properly grounded socket The instrument is fitted with protective and safety devices to prevent electrical shocks The instrument should not be operated without its casin...

Страница 8: ...you see Then Note Read the statement following the symbol The statement is alerting you to information that requires your attention Caution Read the statement following the symbol The statement is ale...

Страница 9: ...n Vitro Diagnostic Devices 98 79 EC Biohazard Warning risk of potentially biohazardous infection Warning risk of personal injury or equipment damage Warning risk of sharp object Warning risk of moving...

Страница 10: ......

Страница 11: ...ts for installation 11 2 3 Installing the Solution Tanks 11 2 3 1 Washing Solution 12 2 3 2 Cleaning solution 13 2 3 3 Sanitizing Solution 13 2 4 Waste Disposal 13 2 4 1 Connecting to the Waste Tank 1...

Страница 12: ...Quantitative Tests 28 4 2 Units of Measurement 30 4 3 Final Report 31 5 Maintenance and Troubleshooting 32 5 1 Routine Maintenance 32 5 2 Periodic Maintenance 32 5 3 Troubleshooting 33 5 3 1 Start up...

Страница 13: ...eded to perform the EIA test are incorporated in a single ready to use reagent cartridge The whole EIA procedure is performed automatically without the need for preparation of reagents Samples are dis...

Страница 14: ...capable of bi directional communication with Laboratory Information System LIS A single computer operating with Windows XP SP3 or above can connect and control up to 10 units Fig 1 2 UNION connection...

Страница 15: ...s numbered in sequence from 1 to 30 Fig 1 4 UNION Carousel 1 1 1 2 Dispensers and Punchers The Dispenser and Punchers are coated with high tech nano ceramic to prevent cross contamination effectively...

Страница 16: ...il 2015 4 Fig 1 5 Dispensers and Punchers 1 1 1 3 Washers The washers adopt the double placement design with the residual liquid less than 5ul Two different washers used for different washing buffers...

Страница 17: ...in different channels Fig 1 7 Optical Transmitter 1 1 1 5 Solution Tanks The solution tanks using load cell for performing real time monitoring of liquid flow Fig 1 8 Solution Tanks 1 1 2 Operation U...

Страница 18: ...wn in the figure below Fig 1 9 Main interface 1 2 2 Status Bar The status bar located as Part A at the left side of the screen as shown in Fig 1 9 is referred to as the instrument s status position Wh...

Страница 19: ...trol OPTIONS select the language and other functions QUIT Exit the operating software 1 2 4 Information on Main Operation Window Fig 1 10 Main Operation Interface Clicking on the specific instrument i...

Страница 20: ...ing etc 1 3 Cartridges Each cartridge is supplied with its unique barcode label stuck on its grip see Fig 1 11 The barcode is coded by means of 10 digits code 128 which consist of the following inform...

Страница 21: ...r control No 2 sealed 150 Sorbent well used to put sorbent some of parameters are for biotin or empty No 3 sealed 150 Conjugate well used to put conjugate No 4 sealed 150 TMB well used to put substrat...

Страница 22: ...Unpacking When you receive the system carefully inspect the package If you see any signs of mishandling or damage file a claim immediately with our Customer Service Department or local distributor Aft...

Страница 23: ...reagent lid should not be obstructed and there should be enough room for replacing Washing Buffers and Cleaning solution DI Water All lids must be closed when the instrument is not used Avoid bumping...

Страница 24: ...e compartment Avoid dropping the bottles on the weight sensors or overload the sensors Important All solution tanks must be positioned in its right position to avoid cross contamination 2 3 1 Washing...

Страница 25: ...g solution shares the same position with cleaning solution During the sanitizing process users should replace the cleaning solution with sanitizing solution The sanitation concentrate 20x should be di...

Страница 26: ...e instrument is switched off or in stand by mode Connecting the waste output of the instrument to the drainage should be handled with care Biohazard The waste tank potentially has biohazardous conditi...

Страница 27: ...ly connect the instrument to a grounded socket which meets the requirements as specified in this operation manual 2 6 Connection to the Computer Install UNION operation software in the computer connec...

Страница 28: ...will be displayed as shown in Fig 3 1 Fig 3 1 Main Operation Interface 3 3 Self check The instrument is required to execute a self check before cycle In order to maintain the instrument in optimum ope...

Страница 29: ...fies the followings The load sensor sensors for the solution tanks in order to check the presence of cleaning solution washing buffer A and washing buffer B All the Motors and home sensors checking fo...

Страница 30: ...he number of calibrator s depends on the parameter information All the qualitative parameters just have the ODcut off To run a calibration the test identification code and lot number must be the same...

Страница 31: ...the samples provided that the cartridges are of the same lot number The Quality Control is processed in the same way as any sample Enter the Quality Control Serum barcode either by reading it with th...

Страница 32: ...retaining edges at the end of the slot To remove the cartridge push the grip of the cartridge inward Then free the holder of the cartridge from the retaining edges of the carousel and remove the cartr...

Страница 33: ...by status displayed in the last column of the table to indicate problems of identification The types of status are as follows Expired meaning the cartridge is expired Missing Calibration meaning the...

Страница 34: ...can the QC barcode on the tube containing the Quality Control Add the required volume of QC material into the sample well of the cartridge The calibration data will be processed and stored in QCS of t...

Страница 35: ...Cartridges Scanning Window To update the test method locate the 2D barcode in the box containing the reagent barcode and scan the 2D barcode Fig 3 7 Method Updating Window Once the new method is upda...

Страница 36: ...ed it is possible to check the volume of common reagent required to run and complete the cycle The volume is checked automatically and it is calculated as follows One bottle of concentrated Cleaning S...

Страница 37: ...e no residual Washing Buffer from the previous test remains in the fluidic path Pre warming cooling the cartridge holding Carousel When the run cycle is initiated the instrument checks if the cartridg...

Страница 38: ...to run in different cycles within the run It will be processed one after the other All samples will be pre diluted at the beginning of the first cycle within the run even though different test with d...

Страница 39: ...ng the formula If ODcal is within the following criteria as listed below the Calibration Curve is accepted and the ODcal is stored ODcal0 TODcal ODcal ODcal0 TODcal The Correction Factor Kcal the rati...

Страница 40: ...nd ODlower printed on the QC barcode are affected by the Kcal mentioned in Section 4 1 2 Quantitative Tests 4 1 2 1 Calibration When Calibration is carried out for Quantitative Tests make sure that th...

Страница 41: ...l The calibration ODcal will be accepted or the calibration will be cancelled and the error message will be displayed the Kcal which is the correction Index will be calculated by the formula Kcal ODca...

Страница 42: ...will be used as calibrated OD If ODcal0 TODcal ODcal ODcal0 TODcal The calibrated ODcal will be accepted Or the calibration will be cancelled and the error message will be displayed According the Cal...

Страница 43: ...Expiry date of the cartridges Sample Calibrator Quality Control Identification Absorbance value Concentration or index of the sample calibrator Quality Control Reference Range If the cycle has been st...

Страница 44: ...to start an analysis cycle The procedure to replenish the reagents as follows Disconnect the connecting tubing from the reagent tank s Remove the reagent tank from its slot Replenish the ready for us...

Страница 45: ...ge Error When such error occurs the tests of the corresponding cartridge will be aborted Instrument Error In such an error the whole analysis cycle stops Connection Error This indicates an error with...

Страница 46: ...ostat does not respond Call service Instrument Temp Adj Instrument thermostat out of range The instrument adjusts automatically Recoverable Errors Error Message Description Corrective action Waste Tan...

Страница 47: ...be disabled from the initial check to test partial emptying of the container Waste Pump Fault Error found at the start of the hydraulic check due to damage to the waste pump Circuit Error Error found...

Страница 48: ...ge Corrective action Self checking Stop Handle the error according to displayed If the errors are still detected call service Cartridge Processing Errors The errors described below are detected during...

Страница 49: ...the reporting window Check if the instrument is still working If not this indicates a vital error and the user should contact customer support Analytical Errors The errors described below are detecte...

Страница 50: ...1 6 Power cable for analyzer 1 5 m 1 7 USB cable for analyzer 1 5 m 1 8 Software Disk 1 9 Fuse for Power Supply 3A 5 20 2 10 Patch fuse 2A MTH board 2A1808 2 11 Patch fuse 5A MTH board 5A1808 2 12 Em...

Страница 51: ...all reagent kits Quality Control Internal QC material Included in all reagent kits Test Combination Different tests with the same reaction temperature can be performed simultaneously in one cycle Ligh...

Страница 52: ...ting Temperature 16 28 Humidity 20 RH 80 RH Atmospheric Pressure 86 0kPa 106 0 kPa Others The analyzer should be properly grounded free from electromagnetic interference dust direct sunlight and explo...

Страница 53: ...bration curve 2 Click on the operational window to select or review the Quality Control records according to your needs 3 Self Check Follow the instructions on screen insert a SERVICE cartridge in pos...

Страница 54: ...ollow the instruction to change for sanitization solution After 80 seconds of priming change for cleaning solutionr according to the Instruction The instrument will run the sanitization and then primi...

Страница 55: ...llows A icon will be shown in RUN page and HOME page after one cycle of tests See Fig 6 1 and Fig 6 2 And the boxes in the left side will give red prompts to remind the user to clean needles Fig 6 1 F...

Страница 56: ...Fig 6 3 Step 2 After inserting the service cartridge click icon to automatically clean needles See Fig 6 4 Fig 6 4 The icon will not disappear until the cleaning procedure is complete If this icon is...

Страница 57: ...y for the first time please follow the instructions below Step Overview and select the keyboard mode you need then scan the 2D barcode below it with the barcode scanner after two beeps from the scanne...

Страница 58: ...Host WCF is a framework for building service oriented applications Using WCF data can be sent as asynchronous messages from one service endpoint to another A service endpoint can be part of a continuo...

Страница 59: ...te to contact us in case of any question Customer Service Department SHENZHEN YHLO BIOTECH CO LTD 13th Floor Building A1 Kexing Science Park Keyuan Road Nanshan District Shenzhen 518057 P R China Tel...

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