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Berthold LB 9510, Руководство по эксплуатации

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9 Appendix

 

LB 9510 Lumat 

 

Page 

78

 of 

79

 

71450BA2 Rev. 00, 12/2020 

 

plausible  substitution  values  for  the  maximum  binding  (either  20  %  or 
nearly 100%). 

If in special cases only two value pairs are available for calculation, the 
slope factor is equated with 1. 

 
 

Extrapolation of the Concentration 

If the measured patient concentration is above the standard curve range, 
a linear extrapolation of the measured value is calculated and printed out 
up to 4 times the value of the highest standard. The calculation is done 
according to the following formula: 

 

𝑪

𝒙

=   𝑪

𝒏

+ 

𝑩

𝒙

− 𝑩

𝒏

𝒇

(

𝒏

)

 

 

 

 

Содержание LB 9510

Страница 1: ...LB 9510 Lumat Luminescence Tube Luminometer Operating Manual 71450BA2 Rev No 00 12 2020...

Страница 2: ......

Страница 3: ...ENT INCLUDING YOUR USE OF IT This instrument is not designed or intended for use with installations or equipment in hazardous environments Servicing of the instrument must only be performed by Berthol...

Страница 4: ......

Страница 5: ...7 3 2 3 View Menu 18 3 2 4 Instrument Menu 18 3 2 5 Tools Menu 19 3 2 6 Help Menu 20 4 Operation with ICE 21 4 1 Define a Raw Data Protocol 22 4 2 Perform a Raw Data Measurement 29 4 2 1 The Kinetics...

Страница 6: ...the Priming Sequence 65 5 1 3 Emptying Tubings 67 5 1 4 Cleaning the Tubings 68 5 2 Further maintenance information 69 6 Quality Control Check 70 7 Warranty and Technical Issues 71 7 1 Special Spare...

Страница 7: ...Information Berthold Technologies GmbH Co KG Calmbacher Str 22 75323 Bad Wildbad Germany Sales and Customer Service Internet www berthold com Phone 49 7081 177 0 Fax 49 7081 177 100 E Mail bio berthol...

Страница 8: ...d NOTICE If this information is not observed deterioration in the operation and or property damage may occur IMPORTANT Sections marked with this symbol point out important information on the product o...

Страница 9: ...make a note of the IDs and revision numbers of both manuals in case you need to replace lost manuals Always read the Safety Manual completely prior to the Operating Manual and both before first use of...

Страница 10: ...ware installation Do not connect the instrument to PC during software installation Install the ICE software first Install the respective driver afterwards For installation local administrator level is...

Страница 11: ...4 Follow the installation wizard Select insert your entries Confirm your entries with OK or Next Close the dialog with finished 5 The ICE Software icon will appear on your desktop after installation...

Страница 12: ...ter the user s name the company name and the provided password Click Register Now Upon entry of the correct password continue using the soft ware The Registration Form dialog box will not appear again...

Страница 13: ...idual changes are not re commended Confirm your entries with Next 7 Complete the installation with Finish 8 Connect the USB cable to a USB port of the computer and the other end to the USB port auf th...

Страница 14: ...of both adapters in their efficiency to transmit the light to the detector are usually very similar For extremely precise measure ments or in case one of the adapters got dirty you can adjust both re...

Страница 15: ...d to be copied to each user s ParaLumat directory File Names There is no limitation in naming data and protocol files other than the Microsoft Windows conventions Data file names are to be defined pri...

Страница 16: ...tware ICE LB 9510 Lumat Page 16 of 79 71450BA2 Rev 00 12 2020 3 2 ICE User Interface 3 2 1 ICE Default Setup Default main screen of ICE To return to the default layout after any changes you may have t...

Страница 17: ...ile As saves loaded parameter settings with a new name Open Data File opens an existing measurement Save Data File saves displayed data Save Data File As saves displayed data with a new name Export ex...

Страница 18: ...Panel shows hides navigation panel on the left Lumat adjusts user interface for Lumat Protocol Wizard starts wizard for protocol creation Data displays sample type raw data RLU or RLU s and results e...

Страница 19: ...servoir Boot Instrument boots instrument and re establishes commu nication between in strument and computer 3 2 5 Tools Menu Options Define the Default File Location for the protocol ParaLumat and dat...

Страница 20: ...3 Instrument Control and Evaluation Software ICE LB 9510 Lumat Page 20 of 79 71450BA2 Rev 00 12 2020 3 2 6 Help Menu The Help menu allows you to view basic software information...

Страница 21: ...etric and competitive immunoassays the type of standard isation is defined in the respective measurement protocols In order to provide the utmost light collecting efficiency the tube holders are equip...

Страница 22: ...l kinds of protocols Raw Data Cut Off and Curve Fit IMPORTANT Context specific information icon The cursor may be drawn over the information icons to provide con text specific information for the sett...

Страница 23: ...netics and Calcium influx Flexible This assay type allows a more flexible combi nation of Delay time Dispense settings and Endoint or Kinetic measurement steps DualGlo DualGlo is a Dual Label Assay wi...

Страница 24: ...s Perform Background Measurement Tic the checkbox to activate the submenu The background measurement monitors whether any contamination or tube phosphorescence is present and affects the signal Bkg me...

Страница 25: ...the total time of the Kinetic measure ment 0 86400 s Counting time Insert the counting time of a single kinetic step 0 05 600 s Delay 0 600 s Repeats insert the number of repeats 1 50 000 Perform Back...

Страница 26: ...he Injector Page This page is only available if the measurement type allows the use of injectors To activate an injector click the respective injector button and tic the checkbox use injector x Insert...

Страница 27: ...r Kinetics you may select All curves and Zoomed Curves addi tionally to view the graphs Define page orientation and margins Check if Automatic Print after Measurement is required Click Next 7 Define E...

Страница 28: ...LB 9510 Lumat Page 28 of 79 71450BA2 Rev 00 12 2020 Type your Footer specific for this protocol Define the Directory for the export file Check if Automatic Export is required Click Next 8 Click Finish...

Страница 29: ...t the 1st tube Record a comment if desired 6 Click OK on the Start Dialog screen to start the measurement The tube will be measured and the numerical value of the signal will be displayed in the Data...

Страница 30: ...measurement has finished remove the last sample still in measurement position from the instrument using Instrument Load Tube 4 2 1 The Kinetics Tab When measuring a Kinetic Single or a kinetic measur...

Страница 31: ...s well suited for research applications requiring the use of known stand ards to calculate the concentration of unknowImmunoassay with n sam ples with the help of a standard curve Immnoassay with refe...

Страница 32: ...ed out Proceed as follows to define a protocol 1 Double click New CurveFit in the Protocol Design menu at the left hand navigation bar of the Main Screen Click Next and follow the protocol wizard whic...

Страница 33: ...ions to be compensated for Otherwise the background values may be too high or too low which ei ther distorts the results of the measurement or leads to an exceeding of the threshold The background eff...

Страница 34: ...m ples Reference Standard Curve Choose reference standard curve to use a measured curve and recalibrate it with the help of 2 calibrators Master Curve Choose master curve to use a verified curve for y...

Страница 35: ...rk best For many research as says utilizing a standard curve a log log transformation and linear regression are often used use smoothing only available for Spline If the standard curve fails to meet c...

Страница 36: ...controls are defined in the Curve Properties Page Insert the ac ceptable lower and upper limits calculated concentration values for the controls Click Next 5 Insert the concentrations of standards and...

Страница 37: ...ded by the kit manufacturer insert the RLU values of the standards additionally Replicates Insert the number of replicates 1 10 of your standards controls and calibrators if applica ble Concentration...

Страница 38: ...easurement Cut Off Limits Tic the checkbox to activate the submenu and insert the limit values There will be shown re marks in the report if concentrations are below between or above thresholds Low Li...

Страница 39: ...ce Page shows the sample and replicate se quence to be measured Click Next 9 Define the settings for printout in the Print Page Select the items by dragging from left to right Available items are Page...

Страница 40: ...mean value of the measured sample repli cates Mean conc mean calculated concentration of the sample replicates c v Coefficient of variation Remarks status messages of the instrument Remarks and flags...

Страница 41: ...used they must be primed prior to protocol start Refer to chapter 5 1 1 for details 4 4 1 Measure an immunoassay with full standardization To start a measurement act as follows on the Main screen 1 S...

Страница 42: ...ent to start the next reading Take care of keeping the given sequence 8 Remove the already measured tube 9 Repeat step 7 and 8 until all samples have been measured 10 Click Exit Measurement to end the...

Страница 43: ...be completely useless you may choose to use a curve measured earlier by clicking Use Last Curve 4 4 2 Measure an immunoassay with Reference Curve If you have defined a protocol with a reference stand...

Страница 44: ...the instrument using Instrument Load Tube 8 After all standards have been measured you may click the Standard Curve tab in order to view the standard curve and the respective nu merical values of the...

Страница 45: ...ropriate The edited and recalculated data will be indicated by orange colour 4 4 3 Measure an immunoassay with Master Curve The master standard curve is provided by the kit supplier and has to be ente...

Страница 46: ...calibrators measured earlier A measurement with calibrators must have been performed at least once before Please refer to the recommendations of the kit supplier on the periods for using calibrator d...

Страница 47: ...icon The cursor may be drawn over the information icons to provide con text specific information for the settings and their options To set up a Cut Off protocol proceed as follows 1 Double click New C...

Страница 48: ...e checkbox if desired Click Next 3 The Offset Factors Page appears Settings on the Offset Fac tors Page and the following Flags Limits Page are belonging together Depending on your entries on the Offs...

Страница 49: ...cut off AL High cut off AH CV of samples Define the max acceptable coefficient of var iation of the replicates of the samples above which the results will be flagged Use the settings as described bel...

Страница 50: ...ne the Factor BH a factor to deter mine the negative control s weight on the high cut off Applied formulas Low cut off AL BL NegContr High cut off AH BH NegContr CV of Define the max acceptable coeffi...

Страница 51: ...w which a result will be flagged negative Define the Offset AL a fixed value Define the Lpos factor CL a factor to de termine the positive control s weight on the low cut off High Cut Off i e the RLU...

Страница 52: ...tes of Negative control Define the number Replicates of Positive control Define the number Low Cut Off i e the RLU value below which a result will be flagged negative Define the Offset AL a fixed valu...

Страница 53: ...the replicates of the samples and the controls above which the results will be flagged Low RLU of negative control Define the limit of the RLU value be low which the negative control will be flagged...

Страница 54: ...mber Replicates of Positive control 2 Define the number if positive control 2 is used Low Cut Off i e the RLU value below which a result will be flagged negative The Lpos factor CL is preset to 0 9 sh...

Страница 55: ...will be flagged High RLU of negative control Define the limit of the RLU value above which the negative control will be flagged Limit 1 of ratio cut off Define the limit of the ratio 1 above which th...

Страница 56: ...rameters To activate an injector click the respective injector button and tic the checkbox use injector x Volume insert a volume of 10 100 l Speed select the injection speed 1 5 Speed 2 is preset Dela...

Страница 57: ...ngs for data export in the Export Page Type your Header specific for this protocol Select the Content by dragging from left to right Available items are Sample sample information Read readings Mean me...

Страница 58: ...tocol Preview 3 Enter a file name under which the measurement is to be stored 4 Click Start Measurement A Start Dialog screen will be displayed 5 Insert the 1st tube containing the first replicate of...

Страница 59: ...unction of ICE software The report function is only functional with im munoassay measurements Additionally pure measurement data can be directly exported as Excel file directly printed out The respect...

Страница 60: ...d by default contains Date and time Measurement file name Protocol name and type Measuring Time Lot Number and Comment Standards section with single and average reader values nominal concentrations an...

Страница 61: ...ata print out via Report IMPORTANT Report The report function is only functional with immunoassay measure ments 1 Click on Report The Report form will open See chapter 4 7 3 step 1 for details 2 By cl...

Страница 62: ...click Open 5 Data and parameter files will be loaded visible in the lower status line of the measurement screen and calculations will be performed ac cording to the settings 6 You may now print or exp...

Страница 63: ...it can be edited if nec essary e g because samples have been intermixed or one of multiple replicates was not properly prepared 1 Highlight the specific well Data tab or RLU cells Standard Curve tab 2...

Страница 64: ...Technology recommends strongly to perform the priming with deionized water first and leaving the lines filled with deionized water before priming with reagents to avoid reagent aerosol splashes at the...

Страница 65: ...nds on the screen and wait for the prime process to be finished At the end of the process the Close button is availa ble 7 Click Close to exit the dialog box 8 The injectors are now primed and ready t...

Страница 66: ...reservoir Start Point percentage of the max inj vol End Point percentage of the max inj vol Speed 1 10 Repeats number of repeats Ventilate the injector is completely filled be yond the max injection...

Страница 67: ...apter 5 1 1 Check Use Customized Prime and select the respective file for priming 5 1 3 Emptying Tubings This operation can be used to empty the injection lines after the meas urement and re collect v...

Страница 68: ...on the substances used Berthold Technologies recom mends up to 30 cycles for washing a single injector NOTICE Avoid overflow The maximum capacity of a lumi vial 12 x 75 mm is 5 mL Each Wash Cycle uses...

Страница 69: ...er maintenance information Further information on maintenance items can be found in the Safety Manual Safety Manual Chapter Item 5 1 Replace tubing connections 5 2 Special spare parts 5 3 Replace reag...

Страница 70: ...ecific recommendations included in the package insert of the reagent kit or the standard laboratory protocol for the test to be conducted A failure in the performance of Quality Control checks could r...

Страница 71: ...ion and free of charge any product that under proper and normal use proves to be defective during the warranty period Berthold Technologies shall in no event be liable or responsible for any incidenta...

Страница 72: ...esolve please contact the technical support Please also make sure that you have the relevant information available before contacting Berthold Technolo gies Helpful information would include serial num...

Страница 73: ...ith cubic spline linear regression point to point immunometric ILMA and competitive LIA immunoassays full standardization up to 10 standards master curve universal standard curve with calibrators refe...

Страница 74: ...o saturation at the high RLU end of the curve for both LIA and ILMA types The logit log transformation typically results in a rising of the curve when Bmax is very close to the highest Bn or B0 value...

Страница 75: ...fulfilled and one gets valid points that are connected by a curve Optionally this curve can be printed out The spline algorithm is described in section below 5 With the above curve all control and pa...

Страница 76: ...cu lated relative measuring and statistics error yi of all standard points is smaller than the smoothing factor S The automatic smoothing function ensures that beginning with smooth ing factor 0 the s...

Страница 77: ...plot since there is always a risk that the deviation from the original points may get too large Calculation of a Variable Reference Value for Standardization of the Logit Transformation This is possi...

Страница 78: ...o value pairs are available for calculation the slope factor is equated with 1 Extrapolation of the Concentration If the measured patient concentration is above the standard curve range a linear extra...

Страница 79: ...n 78 File Name 15 File Type 15 Full standardization 41 Further Manintenance Info 69 Help menu 20 ICE Registration 11 ICE Software 15 ICE Software Installation 10 ICE Technical Data 73 ICE User Interfa...

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