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Compliance
KENZA 240 TX
Automatic Biochemistry Analyser
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 :
info@biolabo.fr
W E B : h t t p : / / w w w . b i o l a b o . f r
User's Guide
KENZA 240TX / ISE_EN.DOC V 2011/02
Certification
Certification
<<<<<<<<<<<
ISO 9001:2008
ISO 13485:2004
- 1 -
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Table of Contents
Summary of Contents for BIOLABO Diagnostics KENZA 240 TX
- Page 1 | | | | ISO 9001:2008 Compliance Certification ISO 13485:2004 Certification KENZA 240 TX <<<<<<<<<<< Automatic Biochemistry Analyser 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...
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Page 2: Table Of Contents
SUMMARY GENERAL INFORMATION ......................- 5 - ..........................- 6 - NTRODUCTION ........................- 6 - HOTOMETER ASSEMBLY ..........................- 7 - AMPLING SYSTEM ........................- 7 - EAGENTS AROUSEL ..........................- 7 - ILUTER ODULE ............................ - 7 - AMPLE TRAY ...................... - Page 3 5.5.1 C2 ..........................- 34 - 5.5.2 C10 ..........................- 34 - ......................... - 35 - VALUES AND CHARTS 5.6.1 ....................... - 36 - HECK CONTROL VALUES PREPARE THE RUN ........................- 37 - ........................ - 38 - ATIENTS FUNCTION KEYS ........................
- Page 4 10.1 M ......................- 64 - ANUAL CALCULATION 10.2 R ............... - 65 - ECEIVE ATIENTS INE AND RANSMIT RESULTS 10.3 C LIMS RS-232 ....................- 65 - ONNECTION TO A 10.3.1 ....................... - 65 - ERIAL ETTINGS 10.3.2 ....................- 65 - TRING ESCRIPTION 10.3.3...
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Page 5: General Information
General Information - 5 -... -
Page 6: Introduction
Introduction The KENZA 240 TX and KENZA 240 ISE are Random Access analysers with microprocessor control. The instrument is available as a bench top version. The analyses are performed patient-by-patient, respecting the order of acceptance and the priority assigned. At any moment of the routine, new patients can be added to the worklist. -
Page 7: Sampling System
Scanning is performed on each reading cuvette, with all the available wavelengths, thus allowing the multi- chromatic reading. The reading cuvettes are kept at a temperature of 37° C by means of a single resista nce which heats the cuvette compartment. These are maintained at a temperature of 37°C by the air circulat ing between the rotor walls. -
Page 8: Electronic Control
Electronic control The whole electronic control system is contained in a rack system at the back right of the instrument. The various functions are controlled by five electronic boards. Two of them control the mechanical movements. The ADC board controls the photometer functioning and the signals conversion. The temperature board controls the temperature and the functioning of level sensor. -
Page 9: Technical Specifications
1.11 Technical specifications Principle of Operation Random Access Reading Mode Absorbance (extinction) STAT function Possibility of inserting urgent samples at any moment during the routine. End point with continuous monitoring. Linear regressions for kinetic reactions. Initial Type of analysis Rate (two-point kinetic). Bi-chromatic reactions. Differential reactions (with blank sample). -
Page 10: Installation
Installation - 10 -... -
Page 11: Unpacking The Kenza 240 Tx / Ise
Unpacking the Kenza 240 TX / ISE Carefully inspect the package for any sign of shipping damage. The box contains a shock detector that detects every shock higher than 50G. Check it before opening the box. Caution! If package or contents are damaged, put a claim in with the freight forwarder and notify BIOLABO or your local agent. -
Page 12: Screen Definition
Screen Definition The screen definition has to be set as 800x600. If the definition is higher, the software will work perfectly but the software will appear smaller, in the top left of the screen. : The software allows the use of Touch Screen. Starting operations 1) Wash and fill up the Water tank with distilled water, 2) Wash the waste tank. - Page 13 8) Press “Exit” to return to the main menu. Press the “CK Cuvettes” key and then the “Enter” key. The cuvettes will first be filled with approximately 700 µl of distilled water, after which each will undergo a light beam reading, representing zero or the starting point for analytical measurement. On completion, the following table will be shown with readings performed on 50 cuvettes of various wavelengths.
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Page 14: Preliminary Operations
Preliminary operations - 14 -... -
Page 15: Introduction
• Ipo Cleaning solution Reagent preparation The Kenza 240 TX can be used with all Biochemistry reagents for photometric assay. The information about use of the reagents is indicated in the insert of each kit. Samples The nature of the patient sample to be used varies according to the parameter. Refer to the kit insert to know the sample type and the collection conditions. -
Page 16: Switching Off The Instrument
Switching off the instrument instrument To switch off the instrument, follow the following procedure : switch off the instrument, follow the following procedure : • From the main menu, close the software using the cross button From the main menu, close the software using the cross button •... -
Page 17: Methods Programming
Methods programming - 17 -... -
Page 18: Method Menu
Method menu The method programming menu can be accessed from the main menu by click on : The method programming menu can be accessed from the main menu by click on : The following menu appears : This menu allows accessing the different functions about methods. the different functions about methods. -
Page 19: Methods Lock
Methods lock The methods may be locked. In this case, the methods cannot be created/modified/deleted/arranged or restored. The methods may be locked. In this case, the methods cannot be created/modified/deleted/arranged or restored. 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. - Page 20 Parameter Description Allowed value Code Test code which appears in the test grid. Can be composed of a maximum of 3 characters. Method Description Full test name. Text. Tray Number of the reagent tray on which the Up to 4 reagent trays can be reagent will be located.
- Page 21 Parameter Description Allowed value Sample volume Defines the sample volume (µL) 2-100 (step 1) Water volume Defines the water volume to be added to the 0-300(step 1) reaction mixture (µL) Sample washing Defines the number of washes to be performed by the sampling system after having sampled this test.
- Page 22 : the total volume (water + sample + reagent 1 + reagent 2) must be between 180 and 350µL. Reaction Mode Defines the type of reaction model for 1 (End Point), 2 (Kinetics), 3 (ISE), 4 (Fixed calculation. Time), 5 (Differential). Reading time For kinetics only: time of reading.
- Page 23 Control 1 Enable/disable carrying 1 (Yes), 0 (No) Control 1 during calibration Control 1 Min Val Lower reference value of Control 1 Concentration Control 1 Max Val Upper reference value of Control 1 Concentration Control 2 Enable/disable carrying 1 (Yes), 0 (No) Control 2 during calibration Control 2 Min Val Lower reference value of Control 2...
- Page 24 Model For multi-standard calibrations : Algorithm applied for calculation of the 1 (Log-Logit 4 Parameters), calibration curve. 2 (Log-Logit 5 Parameters), 3 (Exponentiel 5 Parameters), 4 (Polynomial 5 parameters), 5 (Logit 4 Parameters), 6 (Linear & offset). Expresses in percentage and defines the Max Variance 1-100% maximum deviation between the obtained...
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Page 25: Quick Selection Of Reagent Position
Quick selection of reagent position Quick selection of reagent position To select a position for a reagent, you can use the To select a position for a reagent, you can use the function key : The following screen will be displayed: The following screen will be displayed: •... -
Page 26: Modify A Method
You can easily add or remove curves by checking boxes corresponding to an analysis (blank, standard, control, You can easily add or remove curves by checking boxes corresponding to an analysis (blank, standard, control, You can easily add or remove curves by checking boxes corresponding to an analysis (blank, standard, control, ...) or a wavelength. -
Page 27: Reference Ranges
Reference ranges There are two ways to access the reference ranges interface : There are two ways to access the reference ranges interface : 4.8.1 Reference range Reference range for one method Enter the “Modify/View Test” menu for a parameter, Test”... -
Page 28: Reference Ranges For All Parameters
4.8.2 Reference ranges for all parameters. Reference ranges for all parameters. In the menu Method, click on The following window appears: The first type of patients is displayed. You can enter the reference range for all tests. ou can enter the reference range for all tests. Then click on and enter the value for all and enter the value for all... -
Page 29: Print A Method
4.10 Print a method • • select the methods you Click on: want • and click on: Every method will be printed on a separate sheet, on your Every method will be printed on a separate sheet, on your default printer. 4.11 Program Panels The definition of panels of methods allows The definition of panels of methods allows programming the worklist faster: program several methods by clicking... -
Page 30: Calibrations And Controls
Calibrations and controls - 30 -... -
Page 31: Calibrations And Control Menu
Calibrations and Control menu Calibrations and Control menu Only calibrated method are available for patients analyses. To calibrate the methods, enter Only calibrated method are available for patients analyses. To calibrate the methods, enter Only calibrated method are available for patients analyses. To calibrate the methods, enter “Method” menu, and click on: The following screen is the calibration menu. -
Page 32: Carry Out Calibrations And Controls
Carry out calibrations and controls Carry out calibrations and controls To carry out the calibrations, enter the calibration menu. Then select the tests one by one, or click To carry out the calibrations, enter the calibration menu. Then select the tests one by one, or click To carry out the calibrations, enter the calibration menu. -
Page 33: View / Modify Calibrations
View / modify calibrations / modify calibrations To view the calibration results or details, select a test and click on To view the calibration results or details, select a test and click on The following window appears: This screen shows all data regarding calibration : This screen shows all data regarding calibration : •... -
Page 34: View/Modify Controls
View/Modify Controls View/Modify Controls To prepare the control values (target range), click on To prepare the control values (target range), click on , then The following screen appears : To program a control, select the control number, enter a Name and Lot number. Then enter the values (minimum program a control, select the control number, enter a Name and Lot number. -
Page 35: Qc Values And Charts
QC values and charts QC values and charts To check, and edit controls, from the main menu click on To check, and edit controls, from the main menu click on , then The following screen appears: : to check only the last control results, it is easier to access from the calibration menu. You will have on the : to check only the last control results, it is easier to access from the calibration menu. -
Page 36: Check Control Values
5.6.1 Check control values Check control values To check the control values for a test, select it and click on To check the control values for a test, select it and click on Enter the period you want: The control values and statistics will be displayed for this period. The control values and statistics will be displayed for this period. -
Page 37: Prepare The Run
Prepare the run - 37 -... -
Page 38: Patients Function Keys
Patients function keys The patient main menu is as follows: The user can select the type of tray: for primary tubes or cups. (repeat Test) Allows the operator to set the tests and samples to be repeated. Refer § 8.2 Repeat analyses page - 54 -. (Archive) Allows the operator to enter the archive functions, such as retrieving and reporting patients whose tests have been performed previously. -
Page 39: Second Method
2) Then click on “Patients Entry”: The following window is displayed: 3) To register a patient, enter his ID, Name and Type (man, woman, child …). The patient number is the position of the sample on the tray. This field is automatic. The ID is important when the instrument is provided with the barcode reader option. -
Page 40: Use Of Panels
6.2.3 Use of Panels A quick method to program the tests to be performed is to use the test profiles: Click on the profile number you want. The tests pre-set in the profile will be automatically added to the test list. Refer to 4.11 Program Panels page 29. -
Page 41: Prepare Samples
Prepare samples The Kenza 240 TX allows the use of serum cups and/or primary tubes. 2 types of trays can be used : The Kenza 240 TX allows the use of serum cups and/or primary tubes. 2 types of trays can be used : The Kenza 240 TX allows the use of serum cups and/or primary tubes. -
Page 42: Primary Tubes And Serum Cups
6.3.3 Primary Tubes and Serum cups Primary Tubes and Serum cups You can also use primary tubes and serum cups in a sam You can also use primary tubes and serum cups in a same time: • 12mm tubes: use the normal tray and put cups directly in the tray 12mm tubes: use the normal tray and put cups directly in the tray •... -
Page 43: Start Routine
Add the missing reagents, and click on “Start” Add the missing reagents, and click on “Start” . The following window appears: . The following window appears: You can make a check of all reagents volume by clicking on You can make a check of all reagents volume by clicking on . -
Page 44: Information Displayed
The following keys are available: Only Calibration: Launch only the calibrations, even if some patients are set. Launch only the calibrations, even if some patients are set. Calibration + Patients: Calibration + Patients: Launch calibrations and patients. Enter Volume: Enter manually a reagent volume. Enter manually a reagent volume. -
Page 45: Select The Parameters To Be Used
6.5.2 Select the parameters to be used Select the parameters to be used All the calibrated methods or methods for which a calibration has been requested are displayed in the Start All the calibrated methods or methods for which a calibration has been requested are displayed in the Start All the calibrated methods or methods for which a calibration has been requested are displayed in the Start Menu. -
Page 46: Manage Reagents
6.5.3 Manage reagents Manage reagents The instrument has to check that the reagents are present, and the volumes are sufficient for the run. The instrument has to check that the reagents are present, and the volumes are sufficient for the run. The instrument has to check that the reagents are present, and the volumes are sufficient for the run. -
Page 47: During The Run
During the run… - 47 -... -
Page 48: During The Run - Introduction
During the run – introduction During the run, the operator can perform many actions. It is possible to add patient samples, calibrate new methods, add reagent, check and edit results … 7.1.1 Instrument manipulation During the run, the instrument has to be closed. A sensor detects if the cover is open. In this case the instrument stops the needle as soon as it can be stopped, to avoid damages or injuries. -
Page 49: Check Results
The following keys are available: (Stop on Patient Stop on Patient) To continue the run until a done patient, then suspend. The run will To continue the run until a done patient, then suspend. The run will stop, but the worklist will be stored. stop, but the worklist will be stored. -
Page 50: Stat Sample - Urgent Analysis
STAT sample – urgent analysis Urgent samples 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, just program a new sample and define it as Stat: - 50 -... -
Page 51: After The Run
After the run - 51 -... -
Page 52: Check Results
Check results 8.1.1 Patients results Patients results To check the patients results, open the menu “Patient” check the patients results, open the menu “Patient” and click on The patient list is displayed: The results available for each patient are displayed in the right frame. Click on a patient to access his results. each patient are displayed in the right frame. -
Page 53: Patient Results - Details
8.1.2 Patient results Patient results - Details Many data are collected during every analysis. All the data can be accessed, and can be displayed Many data are collected during every analysis. All the data can be accessed, and can be displayed Many data are collected during every analysis. -
Page 54: Repeat Analyses After The Run
Repeat analyses after the run after the run The analyses can be repeated automatically or manually. ted automatically or manually. To request a test repetition, enter Patient Menu request a test repetition, enter Patient Menu then click You can use several functions button: You can use several functions button: (With Dilution) Repeat the tests with sample dilution. -
Page 55: Print Results
Print results 8.3.1 Laboratory Laboratory Header The laboratory Header is printed as header of all patient reports. The laboratory Header is printed as header of all patient reports. To configure it, enter the Patient Menu 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 The header can be composed of 4 lines at the top for the Laboratory detail, and 1 line at the bottom of paper... - Page 56 8.3.3 Print results f Print results from Report Menu The report menu is accessible in the Patient Menu nu is accessible in the Patient Menu . Click on (Patient List) Printing interface of the patient list. ) Printing interface of the patient list. (Reports) Print the reports patient by patient.
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