BIOLABO Diagnostics KENZA 240 TX User Manual Download Page 1

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Compliance

 

 

 

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Certification

 ISO 9001:2008 

        

Certification

 ISO 13485:2004 

KENZA 240 TX         

 

 

 

 

 

 

   

  

 

Automatic Biochemistry Analyser

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User’s Guide 

KENZA 240TX / ISE_EN.DOC V 2011/02 

Device of In Vitro Diagnosis for analyses of Medical Biology (Clinical Chemistry) 

Only for professional use - Respect the legislation in force 
  
Conform to the Directive 98/79/CE 
 
Code GMDN: 15165 

B I O L A B O   S A   ( p a i d - u p   capital 119 700 €) 
L e s   H a u t e s   R i v e s    
F - 0 2 1 6 0   M A I Z Y   ( F R A N C E )  
T e l :   ( 3 3 )   0 3   2 3   2 5   1 5   5 0  
F a x :   ( 3 3 )   0 3   2 3   2 5 6   2 5 6  
H e a d q u a r t e r :   0 2 2 2 0   P A A R S   ( F R A N C E )  
E m a i l :  

[email protected]

 

                  W E B :   h t t p : / / w w w . b i o l a b o . f r

 

Summary of Contents for KENZA 240 TX

Page 1: ...In Vitro Diagnosis for analyses of Medical Biology Clinical Chemistry Only for professional use Respect the legislation in force Conform to the Directive 98 79 CE Code GMDN 15165 BIOLABO SA paid up ca...

Page 2: ...LES 15 3 3 REAGENT PREPARATION 15 3 4 SAMPLES 15 3 5 SWITCHING ON THE INSTRUMENT 15 3 6 SWITCHING OFF THE INSTRUMENT 16 3 7 MAIN MENU AND SUB MENUS 16 4 METHODS PROGRAMMING 17 4 1 METHOD MENU 18 4 2 M...

Page 3: ...6 5 4 START THE RUN 46 7 DURING THE RUN 47 7 1 DURING THE RUN INTRODUCTION 48 7 1 1 INSTRUMENT MANIPULATION 48 7 1 2 RUN MENU 48 7 2 CHECK RESULTS 49 7 3 REPEAT ANALYSES DURING THE RUN 49 7 4 ADD PAT...

Page 4: ...D ERROR MESSAGES 70 11 1 RESULTS FLAGS 71 12 OTHER INFORMATION 73 12 1 TRAININGS 74 12 2 WARRANTY LIMITS 74 12 3 REQUEST OF ASSISTANCE 74 12 3 1 PROTOCOL OF REQUEST 74 12 3 2 DECONTAMINATION OF THE IN...

Page 5: ...5 1General Information...

Page 6: ...y required to meet the different needs of each analysis laboratory The Kenza 240 TX and ISE are composed of the part described bellow 1 2 Photometer assembly The photometer used in the KENZA 240 instr...

Page 7: ...ossible to use up to 60 different reagents The carousel is cooled at a temperature which is about 8 10 C lower than room temperature 1 5 Diluter Module The diluter module is designed to achieve a samp...

Page 8: ...1 10 Management Computer System The external computer managing the KENZA 240 is a standard computer with at least 512 MB RAM and a hard disk of a minimum of 40 GB a CD player and at least one COM1 ser...

Page 9: ...the analysis routine Reading carousel 50 optical cuvettes path 0 6 mm Automatic 3 step washing station Temperature controlled at 37 C 0 5 Optical system Interference filters photometer with wavelength...

Page 10: ...10 2Installation...

Page 11: ...e g heaters ovens under high power lamps under direct sunlight near strong electromagnetic sources e g motors The optimal operational temperature range is 15 32 C and humidity must be under 70 at 32...

Page 12: ...Washing Prime Priming of washing hydraulic circuit Select language Allows the operator to change the language used To make the language change effective the operator must restart the software Set step...

Page 13: ...smittance via cuvette 1 at different wavelengths and writes the values in line 01 of the table It then performs this same operation for cuvette 2 subtracting the transmittance values from those of cuv...

Page 14: ...14 3Preliminary operations...

Page 15: ...ic assay The information about use of the reagents is indicated in the insert of each kit 3 4 Samples The nature of the patient sample to be used varies according to the parameter Refer to the kit ins...

Page 16: ...nstrument is off To avoid le do not unplug the instrument menus In the Main menu the user can have a general look of the status of instruments including a graphic representation of the reagents and sa...

Page 17: ...17 4Methods programming...

Page 18: ...om the main menu by click on the different functions about methods View Modify Controls to access and edit the control values View Modify STD to access and edit standard values to view print check the...

Page 19: ...ed the method will not be saved The methods may be locked In this case the methods cannot be created modified deleted arranged or restored The methods can be viewed and exported To unlock the methods...

Page 20: ...ank only reagent over which the reagent cannot be considered as working correctly OD Value Decimal Positions Here the operator can define how many decimal figures will be displayed for the result and...

Page 21: ...est The standard positions can be shown by clicking on the button View STD positions 1 8 Reag 1 Vol Defines reagent 1 volume L 2 350 step 1 Reag 1 Pos Defines reagent 1 position Refer to 0 Quick selec...

Page 22: ...the adding of sample R1 15 300 seconds The cycle for R2 adding is 15 seconds This time has to be lower than incubation time Filter 1 Selection of main wavelength 340 380 405 505 546 570 600 620 700 F...

Page 23: ...on 1 Yes 0 No Control 2 Min Val Lower reference value of Control 2 Concentration Control 2 Max Val Upper reference value of Control 2 Concentration N No ot te e Controls 1 and 2 have fixed positions C...

Page 24: ...e and defines the maximum deviation between the obtained calibration points and the calculated curve according to the pre selected mathematic model 1 100 Predilution ratio Samples controls Predilution...

Page 25: ...To see the details of a calibrated method you can click on The following window appears Quick selection of reagent position To select a position for a reagent you can use the function key The followin...

Page 26: ...ethods contact you local agent Program a new method You can easily add or remove curves by checking boxes corresponding to an analysis blank standard control data by clicking on as explained in the pa...

Page 27: ...imum value for estimated normal range These values have to be determined by the biologist Then click on to enter the values for the others kinds of patients There are two ways to access the reference...

Page 28: ...e all your methods are deleted and replaced by the methods contained in the saved file The restoration will also cancel the controls and calibration d Reference ranges for all parameters ou can enter...

Page 29: ...r ri in nt t a a Every method will be printed on a separate sheet on your The definition of panels of methods allows programming the worklist faster program several methods by clicking 40 Select a Pan...

Page 30: ...30 5Calibrations and controls...

Page 31: ...r The following screen is the calibration menu Patient List imports the analyses programmed in the current patient list Calibrate Selected Tests goes to the next step of the calibration sequence print...

Page 32: ...one or click import the tests from the current patients list You can Delete Standards to against factors Delete controls to run only control Modify Standards concentrations In this case the concentrat...

Page 33: ...calculation model To display calibration and controls charts and click Refer paragraph 4 6 modify calibrations To view the calibration results or details select a test and click on This screen shows a...

Page 34: ...d of controls have been developed C1 and C2 are at fixed positions These controls are the most commonly used C3 to C10 are used for specific controls urine controls HDL LDL CK MB controls NH3 EtOH CO2...

Page 35: ...l for external data QC values and charts To check and edit controls from the main menu click on then to check only the last control results it is easier to access from the calibration menu You will ha...

Page 36: ...ot te e The graph can be used to check the statistics Check control values To check the control values for a test select it and click on The control values and statistics will be displayed for this pe...

Page 37: ...37 6Prepare the run...

Page 38: ...different formats Refer 8 3 3 Print results from Report Menu page 56 Laboratory Heading to define a header for the laboratory which will be printed on test reports Refer 8 3 1 Laboratory Header page...

Page 39: ...lysis to be performed as shown 5 Then press The next patient can be entered 6 A patient can be set as a Patient Stat Control 3 to Control 10 Patient normal patient Stat Urgent Patient The sample set a...

Page 40: ...esults Next Allows memorizing the patients data and requests and goes to the next available record where the new patient will be entered Previous Returns to the record of the previous patient to verif...

Page 41: ...types of trays can be used 12mm Tray to use serum cups or primary tubes 12x100mm 16mm Tray to use primary tubes 16x100mm Serum cups only The serum cups tray allows the use of serum cups In the softwar...

Page 42: ...same time 12mm tubes use the normal tray and put cups directly in the tray 16mm tubes use specific tray and adapters for cups The serum level sensor must be enabled and you must be very careful to po...

Page 43: ...ents and samples are ready enter the start menu Add the missing reagents and click on Start The following window appears You can make a check of all reagents volume by clicking on The instrument will...

Page 44: ...perform or calibrate Used if you don t want to work with all to check the reagents level The instrument compares the reagent volume to the reagent needed to carry out the worklist to read the barcode...

Page 45: ...ethods to avoid for example the check of all volumes and save time You can also decide to perform only a few analyses and keep the other program analyses for a following run To select the tests you wa...

Page 46: ...e not yet available It will then corresponding to each test in the Vol column A indicates that the volume is insufficient You can enter manually the volumes by selecting a test The following popup app...

Page 47: ...47 7During the run...

Page 48: ...controls safely Once the cover is closed the operator has to click to start again the instrument I Im mp po or rt ta an nt t the instrument must work closed all covers in positions including the smal...

Page 49: ...The run will stop but the worklist will be stored To add serum or new samples To add reagent if insufficient or new reagents to abort the run To access the patients menu To access the methods menu Met...

Page 50: ...s can be added at anytime during the run An urgent Stat sample is used in priority The instrument will perform all urgent analyses immediately before continuing his routine work To program Stat sample...

Page 51: ...51 8After the run...

Page 52: ...an analys Print To print a patients results Patients results check the patients results open the menu Patient and click on each patient are displayed in the right frame Click on a patient to access hi...

Page 53: ...understanding To access the data select a patient result and click on Patient information Optical densities plot for kinetics and Fixed time Results N No ot te e if an analysis has been r stored as pr...

Page 54: ...on enter Patient Menu then click You can use several functions button Repeat the tests with sample dilution The sample volume will be decrease and the result will be calculated automatically Repeat th...

Page 55: ...reports To configure it enter the Patient Menu and click on The header can be composed of 4 lines at the top for the Laboratory detail and 1 line at the bottom of paper Print results from Patient List...

Page 56: ...All Prints all the tests The results are gather Print results from Report Menu nu is accessible in the Patient Menu Click on Printing interface of the patient list Print the reports patient by patient...

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