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Riele 4040+ Operating Instructions Manual

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Operating Instructions
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Photometer 4040
ROBERT RIELE GmbH & Co KG
Software Version 2.2
Documentation Version 08.2017

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Summary of Contents for Riele 4040+

  • Page 1 Operating Instructions Photometer 4040 ROBERT RIELE GmbH & Co KG Software Version 2.2 Documentation Version 08.2017...
  • Page 2 Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). Furthermore, the Photometer 4040 is manufactured according to the special safety requirements for IVD medical devices stated in EN 61010. ROBERT RIELE GmbH & Co KG Page 2 GENERAL NOTES...
  • Page 3 If a sample is spilled on the device, wipe up immediately and apply disinfectant. Waste Handle liquid waste properly, according to legislation on water pollution, and on the treatment of drainage and waste matter. ROBERT RIELE GmbH & Co KG Page 3 GENERAL NOTES...
  • Page 4 +49 (0)30 404 05 29 E-mail: info@riele.de www.riele.de QUALITY MANAGEMENT SYSTEM ROBERT RIELE GmbH & Co KG maintains a quality management system according to ISO 13485, certified by mdc medical device certification GmbH. ROBERT RIELE GmbH & Co KG Page 4 GENERAL NOTES...

  • Page 5: Table Of Contents

    Calculation procedure 13 (TRANSMISSION) ................. 38 6.4.14 Calculation procedure 14 (C/F Delta)..................39 6.4.15 Calculation Procedure 15 (C/F 3 WL) ..................41 6.4.16 Calculation Procedure 16 (DELTA R1R2) ................42 METHOD EDITOR ..................44 ROBERT RIELE GmbH & Co KG Page 5 CONTENTS...
  • Page 6 SHORT SPECIFICATIONS ......................68 11.5 TECHNICAL SPECIFICATIONS ..................... 69 ACCESSORIES AND SPARE PARTS ............71 METHOD LIST .................... 72 13.1 BASIC METHODS.......................... 72 13.2 LIST OF USER SPECIFIC METHODS ..................73 ROBERT RIELE GmbH & Co KG Page 6 CONTENTS...
  • Page 7 FLASH MEMORY technology: The operating system can be updated with program novelties and/or improvements comfortably, without having to open the equipment (please ask distributor for further information). ROBERT RIELE GmbH & Co KG Page 7 1 - INTRODUCTION TO PHOTOMETER 4040...

  • Page 8: Introduction To Photometer 4040 Installation

    - printed out. V 2 . 2 a d d / m m / y y w w w . r i e l e . d e ROBERT RIELE GmbH & Co KG Page 8 2 - INSTALLATION...

  • Page 9: Loading Printer Paper

     Insert printer paper reel into the axis guide.  Push the printer paper through the slot in the printer cover and close the printer with the cover. ROBERT RIELE GmbH & Co KG Page 9 2 - INSTALLATION...

  • Page 10: Operating Elements

    4040+e_22.docx / 06.10.17 OPERATING ELEMENTS FRONT printer cover working area touchscreen BACK ROBERT RIELE GmbH & Co KG Page 10 3 - OPERATING ELEMENTS...

  • Page 11: Touchscreen

    Trigger a normal measuring by [RESULT]. 3.5.2 Reducing the minimum measuring volume The minimum measuring volume can be reduced from 500 µl to 250 µl. Spacers can be inserted into the measuring cells. ROBERT RIELE GmbH & Co KG Page 11 3 - OPERATING ELEMENTS...

  • Page 12: Program Selection In Modus 1

    METHOD NEW /CHANGE / COPY (chapter 4.3 - Method editor). The transmission of a method collection is possible by PC with special software. Further information: Application sheets of reagent manufacturers ROBERT RIELE GmbH & Co KG Page 12 4 - PROGRAM SELECTION...

  • Page 13: Measurement With Basic Methods

    3 7 . 0 ° C i 3 7 . 0 ° C 0 7 / 2 4 / 2 0 1 7 1 0 : 1 4 Chapter: 7 - METHOD EDITOR ROBERT RIELE GmbH & Co KG Page 13 4 - PROGRAM SELECTION...

  • Page 14: Utility Programs

    1 0 : 1 4 Line feed [LF] Pressing [LF] in the main menu triggers a line feed in the case of activated printer. Several lines advanced continuous pressure on [LF]. ROBERT RIELE GmbH & Co KG Page 14 4 - PROGRAM SELECTION...

  • Page 15: Operation In Modus 2

    When the [Z] button returns to blue the result button [R] may be pushed. ROBERT RIELE GmbH & Co KG Page 15 4 - PROGRAM SELECTION...
  • Page 16 If R^2 is activated, the term LINEAR or NON- LINEAR is shown in the upper right corner. By [PRINT] a graphical printout is generated. By [LIST] all data points are shown sequentially. ROBERT RIELE GmbH & Co KG Page 16 4 - PROGRAM SELECTION...

  • Page 17: Calculation Procedures

    For a homogeneous solution the input of a delay before a measuring is possible at all methods.  All delay times can be aborted by pressing the touchscreen at any place for a long time. ROBERT RIELE GmbH & Co KG Page 17 6 - CALCULATION PROCEDURES...

  • Page 18: Fundamental To The Methods With Standard

    The bichromatic wavelength might be not included in the standard set of filters. The bichromatic wavelength can be set after calling a method (chapter 6 METHOD EDITOR Fig. 6.5). ROBERT RIELE GmbH & Co KG Page 18 6 - CALCULATION PROCEDURES...

  • Page 19: Fundamental To The Kinetic

    Only if MAX. VALUE is set and the sign of the measured value is not equal to the sign of the entered MAX. VALUE a message RANGE +/- is shown. The parameters MIN. VALUE, MAX. VALUE and MIN. R^2 are deactivated entering a zero value. ROBERT RIELE GmbH & Co KG Page 19 6 - CALCULATION PROCEDURES...
  • Page 20 [LIST] all data points are shown sequentially. Sequential View of data points after confirming [DIAG] and [LIST] By [NEXT] for each data point the numeration the time [s] and the extinction is shown. ROBERT RIELE GmbH & Co KG Page 20 6 - CALCULATION PROCEDURES...
  • Page 21 0.0365 deltas these are marked with a “x”. If this procedure does not lead to an improvement deltas reconsidered calculation procedure and none of the deltas are marked. ROBERT RIELE GmbH & Co KG Page 21 6 - CALCULATION PROCEDURES...

  • Page 22: Fundamental To The Methods With Reagent Blank

    Stored results can be output through serial interface (chapter 8.2.8 - Stored results).  When memory is full oldest test results will be overwritten or you can send all results through the serial interface and then delete them. ROBERT RIELE GmbH & Co KG Page 22 6 - CALCULATION PROCEDURES...

  • Page 23: Abbreviations

    TRANSM., T ..Transmission in % ......At Fixed Time: incubation time in seconds ......At Fixed Time: reaction time in seconds ......At Kinetic: time per delta in seconds ROBERT RIELE GmbH & Co KG Page 23 6 - CALCULATION PROCEDURES...

  • Page 24: Survey Of The Methods

    CP-No......Number of the calculation procedure (chapter 7 - METHOD EDITOR) Characteristic ....Name of the calculation procedure (chapter 13.1 - BASIC METHOD) Calculation formula ..Calculation basis of basic method ROBERT RIELE GmbH & Co KG Page 24 6 - CALCULATION PROCEDURES...

  • Page 25: Description Of Method Procedures

    Switch printer ON/OFF / printout of current time by [TIME] [DETAIL] Display/printout of detailed results [M-STD] Multi standard functions [E1/E2] Change to measuring E2 (chapter 6.4.14) [RETRY] Repeat a measurement [RETURN] Return to normal functions ROBERT RIELE GmbH & Co KG Page 25 6 - CALCULATION PROCEDURES...

  • Page 26: Calculation Procedure 1 (C/F)

    - - - - - - - - - - - - Method procedure: Insert / measure zero solution MEASURE ZERO ABS. RESULT Insert / measure sample 0.675 19.8 0.843 24.8 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 26 6 - CALCULATION PROCEDURES...

  • Page 27: Calculation Procedure 2 (C/F/Rb)

    Insert / measure zero solution MEASURE ZERO Insert / measure reagent blank Rb[A]: 0.058 ABS. RESULT Insert / measure sample 1.064 1.188 Insert / measure sample 1.340 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 27 6 - CALCULATION PROCEDURES...

  • Page 28: Calculation Procedure 3 (C/F/Sb)

    Sb[A]: 0.671 1.215 4.25 Insert / measure sample blank Sb[A]: 0.884 Insert / measure sample 1.033 4.23 Sb[A]: 0.702 Insert / measure sample blank Insert / measure sample ROBERT RIELE GmbH & Co KG Page 28 6 - CALCULATION PROCEDURES...

  • Page 29: Calculation Procedure 4 (C/F/Sbrb)

    DELTA Rb: 0.113 ABS. RESULT Insert / measure sample blank 0.715 Insert / measure sample Sb[A]: 0.486 0.646 Insert / measure sample blank Sb[A]: 0.497 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 29 6 - CALCULATION PROCEDURES...

  • Page 30: Calculation Procedure 5 (C/S)

    (Averaged standard) ST[A]: 1.088 (Resulting factor) FACTOR: 5.10 ABS. RESULT Insert / measure sample 1.026 5.23 1.357 6.92 Insert / measure sample 1.582 8.07 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 30 6 - CALCULATION PROCEDURES...

  • Page 31: Calculation Procedure 6 (C/S/Rb)

    (Averaged standard) ST[A]: 1.121 (Resulting factor) FACTOR: 148.2 ABS. RESULT Insert / measure sample 1.449 198.7 1.118 149.6 Insert / measure sample 2.006 281.2 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 31 6 - CALCULATION PROCEDURES...

  • Page 32: Calculation Procedure 7 (C/S/Sb)

    Sb[A]: 0.257 Insert / measure sample blank 2.340 198.0 Insert / measure sample Sb[A]: 0.300 2.223 197.2 Insert / measure sample blank Sb[A]: 0.193 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 32 6 - CALCULATION PROCEDURES...

  • Page 33: Calculation Procedure 8 (C/S/Sbrb)

    Insert / measure sample Sb[A]: 0.535 1.394 8.39 Insert / measure sample blank Sb[A]: 0.329 Insert / measure sample Insert / measure sample blank Insert / measure sample ROBERT RIELE GmbH & Co KG Page 33 6 - CALCULATION PROCEDURES...

  • Page 34: Calculation Procedure 9 (Ftk/F/Rb)

    RESULT 1.005 910.7 Insert / measure sample DELTA [A]: 0.331 1.029 1128.1 DELTA [A]: 0.410 Insert / measure sample 0.829 1381.2 DELTA [A]: 0.502 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 34 6 - CALCULATION PROCEDURES...

  • Page 35: Calculation Procedure 10 (Ftk/S/Rb)

    RESULT Insert / measure sample 0.326 9.84 DELTA [A]: 1.005 0.336 10.81 Insert / measure sample DELTA [A]: 1.103 0.329 12.84 DELTA [A]: 1.310 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 35 6 - CALCULATION PROCEDURES...

  • Page 36: Calculation Procedure 11 (Kin/F/Rb)

    Detail print-out of ABS.1, ABS.2 and deltas. A detail print-out of ABS.1, ABS.2 and deltas can be made after each measurement with [MODE] [MODE] [DETAIL] (see chapter 6.1.7 Fundamental to the Kinetic…). ROBERT RIELE GmbH & Co KG Page 36 6 - CALCULATION PROCEDURES...

  • Page 37: Calculation Procedure 12 (Kin/S/Rb)

    Insert / measure sample R^2: 0.9997 A detail print-out of ABS.1, ABS.2 and deltas can be made after each measurement with [MODE] [MODE] [DETAIL] (see chapter 6.1.7 Fundamental to the Kinetic…). ROBERT RIELE GmbH & Co KG Page 37 6 - CALCULATION PROCEDURES...

  • Page 38: Calculation Procedure 13 (Transmission)

    UNIT: Method procedure: Insert / measure zero solution MEASURE 100% ABS. RESULT Insert / measure sample 0.329 46.9 Insert / measure sample 1.004 Insert / measure sample 2.020 ROBERT RIELE GmbH & Co KG Page 38 6 - CALCULATION PROCEDURES...

  • Page 39: Calculation Procedure 14 (C/F Delta)

    T3: Delay, optional : manual process A: Start of time controlled measuring E1: Start of first course (E1) E2: Start of second course (E2) Fig. 6.4.14.1: time controlled measuring ROBERT RIELE GmbH & Co KG Page 39 6 - CALCULATION PROCEDURES...
  • Page 40 Measure all samples E2 (maximum 25) 0.000 1.530 0.000 1.384 RESULT Results based on the differences of the measured samples 0.446 0.392 0.307 Show the results by [MODE] [MODE] [DETAIL] ROBERT RIELE GmbH & Co KG Page 40 6 - CALCULATION PROCEDURES...

  • Page 41: Calculation Procedure 15 (C/F 3 Wl)

    - - - - - - - - - - - - Insert / measure zero solution MEASURE ZERO µmol/L mg/dl The result will be displayed in two units of measurement 4.859 7.83 5.865 9.45 Insert / measure sample ROBERT RIELE GmbH & Co KG Page 41 6 - CALCULATION PROCEDURES...

  • Page 42: Calculation Procedure 16 (Delta R1R2)

    3 7 . 0 ° C i 3 7 . 0 ° C 0 7 / 2 4 / 2 0 1 7 1 0 : 1 4 info line Fig. 5.4.16.2: screen during the method ROBERT RIELE GmbH & Co KG Page 42 6 - CALCULATION PROCEDURES...
  • Page 43 Insert / measure samples with reagent 2 0.285 0.165 The user is guided through the measuring procedure on the 0.165 0.165 screen. RESULT The result will be displayed -0.116 -0.116 -0.116 ROBERT RIELE GmbH & Co KG Page 43 6 - CALCULATION PROCEDURES...

  • Page 44: Method Editor

    This function is very useful if a basic method with setting parameters successfully tested. These parameters can be saved as a new method starting from no [EXIT] Return to main menu ROBERT RIELE GmbH & Co KG Page 44 7 - METHOD EDITOR...
  • Page 45 8 - M A X . V A L U E then also all data and reserved memory of this method in the quality control are deleted! P 3 / 3 ROBERT RIELE GmbH & Co KG Page 45 7 - METHOD EDITOR...
  • Page 46 In order to set the value to zero enter e.g. “0.0”. [ESC] End input and save curve data For measuring in a multi-standard method at least 2 bases with A and C must be defined! ROBERT RIELE GmbH & Co KG Page 46 7 - METHOD EDITOR...

  • Page 47: Utility Programs

    8.2.10 User name 8.2.11 Error list 8.2.12 Key signal ON / OFF 8.2.13 Touchscreen adjustment 8.2.14 Date / Time 8.2.15 Language 8.2.16 8.2.17 ADC counts (Optic) Service tools 8.2.18 ROBERT RIELE GmbH & Co KG Page 47 8- UTILITY PROGRAMS...

  • Page 48: Description Of Utility Programs

    P L E A S E W A I T program level. Monthly executed the optic adjust- ment compensates possible deviations of measuring accuracy environmental influences. ROBERT RIELE GmbH & Co KG Page 48 8- UTILITY PROGRAMS...

  • Page 49: Multi-Standard Functions

    [PRINT CURVE] After inquiry of the curve number print-out on the internal printer or via the serial interface. For measuring in a multi-standard method at least 2 bases with A and C must be defined! ROBERT RIELE GmbH & Co KG Page 49 8- UTILITY PROGRAMS...

  • Page 50: Printer On / Off

    - - - - - - - - - - - - When printer ON via [MODE] [PRN] 0.675 19.8 after a measurement the current time can be TIME: 11:21:32 printed out by [TIME]. ROBERT RIELE GmbH & Co KG Page 50 8- UTILITY PROGRAMS...

  • Page 51: Bar Code

    Save setting temporarily up to next switch- off of the device by [EXIT] Table 8.2.5.1 Serial Method ID-no. Sample Result Temperature User Date Time control 2250 12345 15.5 [user name] 09/08/09 09:30:47 ROBERT RIELE GmbH & Co KG Page 51 8- UTILITY PROGRAMS...

  • Page 52: Quality Control

    Except the basic methods all methods can be connected with a quality control. The method-typical data of a control serum are entered via the method editor (see chapter 7 METHOD EDITOR). ROBERT RIELE GmbH & Co KG Page 52 8- UTILITY PROGRAMS...
  • Page 53 Print-out of daily memory for serum 1: [PRINT] Print all readings *** DAILY MEMORY ***S1 * [EXIT] Return to QC menu 4040+ PHOTOMETER # 1001 V2.2a dd/mm/yy D LAB.: RIELE BERLIN DATE: 07/17/17 ROBERT RIELE GmbH & Co KG Page 53 8- UTILITY PROGRAMS...
  • Page 54 Delete all measuring data of the monthly memory of the selected method and confirm again (e.g. at change of serum) [MORE] Change to output dialog [EXIT] Return to QC menu ROBERT RIELE GmbH & Co KG Page 54 8- UTILITY PROGRAMS...
  • Page 55 12.74 -2s 02/04/10 12.13 -2s 02/03/10 12.65 -2s 02/02/10 13.11 -1s 02/01/10 13.88 +1s 01/31/10 13.51 -1s 01/30/10 13.24 -1s 01/29/10 12.50 -2s 01/28/10 12.74 -2s 01/27/10 13.30 -1s ROBERT RIELE GmbH & Co KG Page 55 8- UTILITY PROGRAMS...

  • Page 56: Settings Printout

    1: ENGLISH 2: GERMAN KEY SIGNAL ON M.COUNTER : T.COUNTER : 334:45 S.COUNTER : ADJUST OPTIC POSITION : P3-1 3850 7246 D2/3 3500 D1/2 3396 PROGR. METHODS STORED RESULTS ROBERT RIELE GmbH & Co KG Page 56 8- UTILITY PROGRAMS...

  • Page 57: Stored Results

    [] : delete character  [] : blank E S C A / 1 E N T  [ESC] : finish input without storage  [ENT] : finish input with storage ROBERT RIELE GmbH & Co KG Page 57 8- UTILITY PROGRAMS...

  • Page 58: User Name

    Save setting temporarily up to next switch- off of the device by [EXIT]. E X I T S E L E C T The deeper signal tone for error messages remains active in any case. ROBERT RIELE GmbH & Co KG Page 58 8- UTILITY PROGRAMS...

  • Page 59: Touchscreen Adjustment

    After some seconds a deep signal tone sounds and the text message “TOUCHSCREEN ADJUSTMENT” will be shown at the first line of the greeting screen. Release the touchscreen within one second. Execute the adjustment of the touchscreen as described above. ROBERT RIELE GmbH & Co KG Page 59 8- UTILITY PROGRAMS...

  • Page 60: Date / Time

    E X I T S E L E C T Save setting permanently by [OK]. The setting is temporarily saved up to next switch-off of the device by [END]. ROBERT RIELE GmbH & Co KG Page 60 8- UTILITY PROGRAMS...

  • Page 61: Adc Counts (Optic)

    S E R V I C E T O O L S Stop function by [ESC]. P A S S W O R D E S C ROBERT RIELE GmbH & Co KG Page 61 8- UTILITY PROGRAMS...

  • Page 62: Maintenance

    CALIBRATING MEASURING SYSTEM At doubtful measurement results an optic adjustment has to be carried out corresponding to chapter 8.2.1. REPLACEMENT OF PAPER ROLL See chapter 2.4 - LOADING PRINTER PAPER ROBERT RIELE GmbH & Co KG Page 62 9 - MAINTENANCE...

  • Page 63: Replacement Of Line Fuses

    (T)  voltage rating: 250 V  rated current: 1.6 A  marking: T 1.6 A H mains switch fuse holder mains cable connector Connector for Incubator T20 ROBERT RIELE GmbH & Co KG Page 63 9 - MAINTENANCE...

  • Page 64: Error Message / Correction

    (chapter 8.2.1) ROBERT RIELE GmbH & Co KG Page 64 10 - ERROR MESSAGE / CORRECTION...
  • Page 65 2 switch off/on device NAK at reception from module 2 switch off/on device filter position out of tolerance contact service partner ROBERT RIELE GmbH & Co KG Page 65 10 - ERROR MESSAGE / CORRECTION...
  • Page 66 (chapter 8.2.8) BCC error at sending result string send results through serial interface and delete results (chapter 8.2.8) ROBERT RIELE GmbH & Co KG Page 66 10 - ERROR MESSAGE / CORRECTION...

  • Page 67: Technical Data

    Short-term changes of the operational behavior do not influence the overall function of the device. 11.3 TYPE PLATE For installation pay attention to the specifications on the type plate. ROBERT RIELE GmbH & Co KG Page 67 11 - TECHNICAL DATA...

  • Page 68: Short Specifications

    Mains Supply Range: 100 V up to 240 V at 50/60 Hz Dimensions Length 33 cm x width 34 cm x height 18 cm Weight 5.3 kg Marking ROBERT RIELE GmbH & Co KG Page 68 11 - TECHNICAL DATA...

  • Page 69: Technical Specifications

    Model: 4040 Instruction for use: Photometer 4040 , user manual Manufacturer ROBERT RIELE GmbH & Co KG Kurfuerstenstrasse 75-79 13467 Berlin Germany DECLARATION OF CONFORMITY: The above mentioned absorption photometer is in conformity with the following metrological description. Berlin, November 2016 ROBERT RIELE GmbH &...
  • Page 70 Photodiode The optical path in the UV range is directed from the back to the front of the device. Insert standard cuvette accordingly. Lense Cuvette Filter Lense Photodiode ROBERT RIELE GmbH & Co KG Page 70 11 - TECHNICAL DATA...

  • Page 71: Accessories And Spare Parts

    4040-034 Spacer for 250 µl measuring volume 4040-035 Spacer for 500 µl measuring volume 1707574001 Top cover small for printer Incubator T12 Incubator T16 Incubator T20 ROBERT RIELE GmbH & Co KG Page 71 12 - ACCESSORIES AND SPARE PARTS...

  • Page 72: Method List

    20 - 250 ..up to 231 user specific methods (chapter 13.2 - LIST OF USER SPECIFIC METHODS as copy master / to be filled out by the user) 13.1 BASIC METHODS ROBERT RIELE GmbH & Co KG Page 72 13 - METHOD LIST...

  • Page 73: List Of User Specific Methods

    4040+e_22.docx / 06.10.17 13.2 LIST OF USER SPECIFIC METHODS ROBERT RIELE GmbH & Co KG Page 73 13 - METHOD LIST...

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