uf50维修手册完整原版.docx

SERVICE MANUALFULLY AUTOMATED URINE CELL ANALYZERUF-50Section 1SpecificationsSection 2Pneumatics & Hydraulics Section 3ElectronicsSection 4Setting, Checking and Adjustment Section 5Service ProgramSection 6Error Messages Section 7Schematics Appendix AParts List Appendix BInstallationBack to CoverSECTION 1 SPECIFICATIONSSECTION 1 SPECIFICATIONS11.1 INTENDED USE11.2 PRODUCT NAME AND MODEL11.3 SYSTEM CONFIGURATION AND EXPANSION11.3.1 Configuration11.3.2 System Expansion11.3.3 Optional Units and Peripherals21.4 ELECTRICAL SPECIFICATIONS21.4.1 Rated Voltage21.4.2 Power Consumption21.5 DIMENSIONS AND WEIGHT21.6 OPERATION FLOW21.6 OPERATION FLOW31.7 PERFORMANCE SPECIFICATIONS31.7.1 Analysis Parameters31.7.2 Display Items31.7.3 Sample Requirements31.7.4 Analysis Range (Linearity Guaranteed Range)31.7.5 Display Range31.7.6 Reproducibility41.7.7 Accuracy4 1.7.8 Linearity41.7.9 Carryover4 1.7.10 Stability4 1.7.11 Sample Throughput61.7.12 Review Rate (Microscopy Rate)61.8 SYSTEM FUNCTIONS61.8.1 Select Functions61.8.2 Data Storage61.8.3 LCD Display61.8.4 Quality Control71.8.5 Error Alerting7 1.8.6 Maintenance71.8.7 Service (for Factory and Serviceman Use only)81.8.8 Protection81.8.9 Start-Up81.8.10 Anti-Carryover81.8.11 Timer Mode (Sleep Mode)81.8.12 Sampler (optional)81.8.13 Bar Code Reader (option)81.9 ANTI-CARRYOVER FUNCTION91.9.1 Basic Functions91.9.2 Function Trigger Conditions101.9.3 Reliability Guarantee Conditions101.10 REAGENTS101.11 ACOUSTIC NOISE LEVEL101.12 ENVIRONMENTAL REQUIREMENTS101.12.1 Operation101.12.2 Storage101.12.3 Transportation10UF-50 S/MJanuary 1999SECTION 1 SPECIFICATIONS1.1 INTENDED USEThe UF-50 is a fully automated urine cell analyzer using flow cytometry method using fluorescent dye to detect human urine cell components (sediments). All the process from the sample mixing to the output of analysis results are performed automatically.Analysis results are categorized into quantitative analysis and flagging (cell information).Quantitative analysis gives the number of counted cells; RBC, WBC, EC (epithelial cells), casts and bacteria (concentration) in the unit of µL or view field.Flagging parameter provides the RBC morphology information, and shows presence of Path. CAST (casts containing organized structures), SRC (small round epithelial cell), YLC (yeast liked fungi cell), X'TAL (crystal), SPERM (spermatozoa).Analyzed results are displayed on the screen and output to an optional printer or host computer, if provided.1.2 PRODUCT NAME AND MODELName:Fully Automated Urine Cell Analyzer Model:UF-501.3 SYSTEM CONFIGURATION AND EXPANSION1.3.1 ConfigurationThis unit is of a desktop type and it is composed of the following units.(1) Main Unit :(2) Pneumatic unit:PU-15(3) Laser power supply:LPU-3 (for UF-50)(4) Transformer for laser power supply:LPU-2(5) Accessories(6) Sampler Unit (optional) :UFSU-1(7) ID Bar Code Reader (optional) :BR ASSY UF-50UF-50 S/M1-10January 1999Sampler Unit UFSU-1Serial Interface Parallel Interface 1Pneumatic Unit PU-15LPU-2(Transformer Unit)LPU-3(Model 261C)Graphic PrinterHost ComputerID ReaderUF-50BRLCDParallel Interface 2Data Printer or Line Printer: Standard Unit: Optional UnitFigure 1-1-1: Configuration of UF-50 System1.3.2 System Expansion Parallel Interface:2 ports (#1 for graphic printer and #2 for ticket or line printer) Serial Interface:1 port (for host computer)1.3.3 Optional Units and Peripherals(1) Sampler Unit UFSU-1Up to 10 urine collection tubes (for centrifuge sedimentation) in a rack can be set.(2) ID Bar Code Reader BR ASSY UF-50The ID reading unit is model BCR 5342-TIA.(3) Data Printer DP-510To print out the analysis data on card, Data Printer Sysmex DP-510 can be connected. Print format can be set freely within the printing range.(4) Line PrinterFor list printing of analysis results.Hewlett-Packard Laser Jet Series or Tally MT-150 or equivalent(5) Graphic PrinterFor graphic printing with scattergrams and list printing for laboratory filings.Hewlett-Packard Desk Jet 600 Series, Laser Jet Series, Canon BJC Series or Tally MT-7000 Series or equivalent(6) Host Computer1.4 ELECTRICAL SPECIFICATIONS1.4.1 Rated VoltageInput Voltage :AC 100, 117, 220 or 240 V ± 10%, 50/60 ± 1 HzOutput Voltage : DC +12 VDC +5 V6 A10 ADC +30 V15 mADC ±15 V1 ADC +15 V0.3 ADC +12 V0.6 ADC -12 V0.3 AAC 100 V1.5 A1.4.2 Power ConsumptionMain Unit :400 VA or lessPneumatic Unit :280 VA or less Laser Power Supply Unit :1500 VA or less1.5 DIMENSIONS AND WEIGHTComponentWidth (mm)Height (mm)Depth (mm)Weight (kg)Main Unit48070056055Pneumatic Unit19533339516Laser Power Supply LPU-3162912873Laser Power Supply LPU-2 (Power Transformer Unit)22221629023Sampler Unit600932016A(Dimensions excluding protrusions)A:399E045 A1087-1.6 OPERATION FLOWAnalysis Method: Flow Cytometry using Argon Laser(1) Aspirates the mixed sample from the pipette and quantifies it.(2) Dispenses the quantified sample together with diluent into Reaction Chamber, stains and mixes it.(3) Introduces the stained sample into the flow cell and creates the sheath flow.(4) Applies the laser light to the sheath flow and detects the forward scattered light and fluorescence signals, which are generated by cell passing.(5) The detected signal is transported to the wave form processing unit and the parameters such as the wave height value, pulse width, etc. are obtained.(6) Scattergrams are generated by using the obtained parameters and the cell classification is performed from their appearing position on the scattergrams.(7) The count value is obtained for each classified parameter.(8) The count value and/or flagging information for each parameter are displayed on the display.1.7 PERFORMANCE SPECIFICATIONS1.7.1 Analysis Parameters(1) Quantitative Analysis ParametersRBC, WBC, EC (epithelial cells), CAST and BACT (bacteria).(2) Flagging ParametersP. CAST (casts containing organized structures), SRC (small round epithelial cell), X'TAL (crystal), YLC (yeast liked fungi cell), SPERM (spermatozoa), RBC-Info (morphological information) and Cond. (Conductivity)1.7.2 Display Items(1) Date of Measurement(2) Sample Information:Sample ID No., Tube Position, Rack No. (When optional Sampler isinstalled)(3) Status:Indication of sample with error (Err) Sample to be reviewed (Rev)1.7.3 Sample Requirements(1) Sample Type:Human urine(2) Required Sample VolumeManual mode:1 mL (when using CELLAPIT tube from Ono Pharmaceutical Co., Ltd.) Auto mode:4 mL (when using CELLAPIT tube from Ono Pharmaceutical Co., Ltd.)(3) Aspirated Sample Volume: Manual mode:800 µLAuto mode:1500 µL(4) Aspiration limit:Urine specific gravity of less than 1.050 can be aspirated.1.7.4 Analysis Range (Linearity Guaranteed Range)In the case when the RBC concentration in the urine sample is within the following range, the linearity is retained.1 5000 (particles/µL) (Total cell count < 5000 particles/µL)1.7.5 Display RangeParameterRange of Display count/µL or count/fieldRBC0.0-99999.9WBC0.0-99999.9Epithelial Cell0.0-99999.9Cast0.00-9999.99Bacteria0-9999991.7.6 ReproducibilityCoefficient of variation of counting or sensitivity, when control urine is measured consecutively 10 times, lies within the following ranges by the confidence level of 95%.RBC C.V. within ± 10%WBC C.V. within ± 10%ECC.V. within ± 30% CAST C.V. within ± 40% BACT C.V. within ± 20%1.7.7 AccuracyWhen UF CHECK is measured in Control Analysis Mode 10 times continuously, the average value of the analyzer, comparing with that of the reference unit, must fall in the following range.CountRBC + WBC± within 5%1.7.8 LinearityAverage value of count, when each of 1:4 dilution series of UF CHECK is measured consecutively 5 times, compared to the logical concentration, lies within the following permissible ranges.Dilution RatioAcceptable Range1/15000.0 ± 10%1/41250.0 ± 10%1/16312.5 ± 10%1/6478.1 ± 20%1/25619.5 ± 40%1/10244.9 ± 80%1/40961.2 ±160%Assume the cell count of undiluted sample is 5000/µL or field1.7.9 CarryoverCarryover should satisfy the following range.The RBC results of three consecutive analyses of UF CHECK : H1, H2, H3 in orderThe RBC results of three consecutive analyses of UF CHECK:B1, B2, B3 in order RBC : -5% < (B1-B3) / (H3-B3) x 100 (%) < 5%1.7.10 Stability(1) Temperature StabilityAnalyze UF CHECK 10 times consecutively in Control Mode at 15°C, 23°C and 30°C. Obtain the average of count results and sensitivities of these 10 analyses at each temperature. The variation obtained from the following formula should fall within the ranges below.Variation = (Xmax - Xmin) x Xmean x 100%Here, Xmax is the biggest one among these results. Xmin is the smallest one among these results. Xmax is the average of the three results.CountRBCwithin ±10%WBCwithin ±10%ECwithin ±30%CASTwithin ±40%BACTwithin ±20%SensitivityFscwithin ±20%Fsc2 (for BACT)within ±20%Flwithin ±30%Fscwwithin ±20%(2) Within-a-day StabilityAnalyze UF CHECK 10 times consecutively in Control Mode at power ON, 1 hour later, 2 hours later, 4 hours later, 8 hours later and 24 hours later. Obtain the average of count results and sensitivities of these 10 analyses at each time. The variation obtained from the following formula should fall within the ranges below. The variation of environmental temperature during analysis should be within 10°C.Variation = (Xmax - Xmin) x Xmean x 100%Here, Xmax is the biggest one among these results. Xmin is the smallest one among these results. Xmax is the average of the three results.CountRBCwithin ±10%WBCwithin ±10%ECwithin ±30%CASTwithin ±40%BACTwithin ±20%SensitivityFscwithin ±20%Fsc2 (for BACT)within ±20%Flwithin ±30%Fscwwithin ±20%(3) Day-to-day StabilityAnalyze UF CHECK 10 times consecutively in Control Mode for 10 days every day. Obtain the average of count results and sensitivities of these 10 analyses on each day. The variation obtained from the following formula should fall within the ranges below. The variation of environmental temperature during analysis should be within 10°C.Variation = (Xmax - Xmin) x Xmean x 100%Here, Xmax is the biggest one among these results. Xmin is the smallest one among these results. Xmax is the average of the three results.CountRBCwithin ±10%WBCwithin ±10%ECwithin ±30%CASTwithin ±40%BACTwithin ±20%SensitivityFscwithin ±20%Fsc2 (for BACT)within ±20%Flwithin ±30%Fscwwithin ±20%(4) Stability against Voltage VariationAnalyze UF CHECK 10 times consecutively in Control Mode by supplying the 90%, 100% and 110% or the source voltage. Obtain the average of count results and sensitivities of these 10 analyses at each voltage. The variation obtained from the following formula should fall within the ranges below. The variation of environmental temperature during analysis should be within 10°C.Variation = (Xmax - Xmin) x Xmean x 100%Here, Xmax is the biggest one among these results. Xmin is the smallest one among these results. Xmax is the average of the three results.CountRBCwithin ±10%WBCwithin ±10%ECwithin ±30%CASTwithin ±40%BACTwithin ±20%SensitivityFscwithin ±20%Fsc2 (for BACT)within ±20%Flwithin ±30%Fscwwithin ±20%1.7.11 Sample Throughput(1) Measurement time for one sample:Approx. 72 seconds per sample (in the Manual mode)Approx. 86 seconds per sample (in the Auto mode)(2) Throughput:Approx. 50 samples per hour1.7.12 Review Rate (Microscopy Rate)In many hospitals where ratio of samples of in-patients and out-patients is 30:70 to 40:60, the average value of re-analysis rate by a manual microscopy method is 20% or less.(3)Re-analysis rate by a manual microscopy method = (1) + (2)x 100 (%)where,(1) is No. of samples which are judged abnormal by visual inspection,(2) is No. of samples which are determined as "Re-analysis Sample" by the UF-50, and(3) is No. of total samples.1.8 SYSTEM FUNCTIONS1.8.1 Select FunctionsThe following functions can be selected by key entry.(1) Analysis(2) Settings(3) External output(4) Stored sample processing(5) Quality control(6) Maintenance function(7) Service function1.8.2 Data Storage(1) Analysis data (excluding scattergram): 180 samples (BBU Memory)(2) Scattergram data:40 samples (RAM; erased by power OFF)(3) QC data:12 file at 180 points (BBU Memory)(4) Setting values(5) Maintenance data (for customer use)(6) Service Data (for factory and service purpose only)(7) Built-in FD DriveStored sample data (numeric values, scattergram) can be stored in order to use for the service and claim investigation, and the sample survey. However, the data storage for the back-up purpose for the customer is not available.1.8.3 LCD Display(1) The following data is displayed on the black and white LCD (320 x 240 dots).1. Analysis data (excluding scattergram)2. QC data3. Setting Values4. Maintenance Data5. Service Data(2) Display Language Japanese or English1.8.4 Quality Control(1) Method:X control or L-J control(2) Control Parameters:RBC, WBC, EC, CAST, BACT, Fsc, Fsc2, Fl, Fl2, Fscw1.8.5 Error Alerting(1) Instrument Error Monitoring FunctionDuring analysis and ready status, the following items are monitored, and if any abnormality is detected, the alarm sounds and the error message is displayed.1. Hydraulic and Mechanical System Pneumatic pressure and vacuum Reagent amount Motor operation status Unit temperature Laser age(2) Sample Abnormality Monitoring Function1. Abnormal sample:When the following analysis error occurs on a sample, the alarm sounds and the message is displayed. Sample quantification is failed. (Insufficient aspiration due to the high viscosity sample or muddled urine sample) Data sampling condition is bad.2. Reanalysis required sample:The message asking reanalysis by a microscope is displayed for the sample satisfying the following conditions. Abnormal sample with high concentration Sample judged as abnormal conductivity Sample judged to be reanalyzed Sample with abnormal classification Sample with the flagging judgment specified as abnormal judgment item(3) Measured Data Abnormality Monit