This Operator’s Manual should be easily accessible at all times. Training Do not carry out operation tasks or maintenance actions unless you have received training from Roche Diagnostics. Leave tasks that are not described in the user documentation to trained Roche Service representatives.
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® international treaties. Multiplate analyzer contains a user license between F. Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access the software and use it. Unauthorized use and distribution may result in civil and criminal penalties.
Operation 5 Operation Safety Starting the analyzer Using the electronic pipette Performing a measurement Result handling Deleting orders from the worklist Reconstituting reagents and preparing aliquots Multiplate system control Shutting down the analyzer Roche Diagnostics Operator’s Manual · Version 3.0...
Multiplate® analyzer Preface Intended use The Multiplate (multiple platelet function) analyzer is an instrument designed for in- vitro diagnostic use in hospitals and other medical and scientific institutions. Symbols and abbreviations Product names Except where the context clearly indicated otherwise, the following product names and descriptors are used.
Unauthorized access (p. 22) Data security (p. 24) Data alarms (p. 141) Roche-provided firewall Information about Roche-provided firewall added. Barcode reader Information about hand-held barcode reader added. Supported printers Installation information about the Lexmark MS310d printer added. Installing the printer (p. 48) Supported barcode types A list of supported barcode types was added.
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Result deletion Information on how to delete result data was added. Deleting result data (p. 133) Multiplate passwords The purpose of the level 1 and level 2 Multiplate passwords has been changed: the level 1 password is an operator password and the level 2 password is an administrator password.
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What is new in publication version 2.0 Main screen redesigned The main screen of the Multiplate software has been optimized and redesigned. Target range added A target range has been added for each test. The target range can be displayed on the main screen.
Multiplate® analyzer 1 Safety Table of contents Safety In this chapter you find information about the safe operation of the equipment. In this chapter Chapter Safety classification ......................15 Safety precautions.........................16 Operator qualification ....................16 Safe and proper use of the analyzer ................16 Miscellaneous safety precautions .................17...
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1 Safety Multiplate® analyzer Table of contents Safety labels on the equipment ...................25 Disposal of the equipment ....................26 Roche Diagnostics Operator’s Manual · Version 3.0...
Multiplate® analyzer 1 Safety Safety classification Safety classification This section explains how precautionary information is presented in this manual. The safety precautions and important user notes are classified according to the ANSI Z535.6 Standard. Familiarize yourself with the following meanings and icons:...
Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the analyzer. Leave maintenance, installation or service that is not described in the Operator’s Manual to trained Roche Service representatives. Follow standard laboratory practices, especially when working with biohazardous material.
Roche. See Consumables and accessories (p. 64). Third-party software Installation of any third-party software that is not approved by Roche Diagnostics may result in incorrect behavior of the analyzer. Do not install any non-approved software. Non-compliance will void the warranty.
1 Safety Multiplate® analyzer Safety summary Safety summary This safety summary contains the most important and general warning, caution, and notice messages. Additionally, you will find specific safety information in the task descriptions throughout the manual. Warning messages List of warning messages Before operating the analyzer, read the warning messages contained in this summary carefully.
Multiplate® analyzer 1 Safety Safety summary Waste Infection by waste solution Contact with waste solution may result in infection. All materials and mechanical components associated with the waste systems are potentially biohazardous. WARNING Be sure to wear protective equipment. Take extra care when working with protective gloves;...
1 Safety Multiplate® analyzer Safety summary Personal injury and incorrect results due to inappropriate use Inappropriate use of the electronic pipette may lead to personal injuries and incorrect results. WARNING Only use the electronic pipette for pipetting liquids that conform with the intended use of the instrument and the environmental conditions defined in this documentation.
Be sure to wear protective equipment (such as goggles, gloves). Observe the cautions given in the package insert and observe the information given in the Material Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions. If a reagent, detergent or other working solution comes into contact with your skin, wash it off immediately with water and apply a disinfectant.
Do not copy or install any software on the analyzer unless it is part of the system software or you are instructed to do so by a Roche service representative. If additional software is required, contact your Roche service representative to ensure validation of the software in question.
Damage to the analyzer due to improper use NOTICE Should one of the circuit breakers or fuses blow, do not attempt to operate the analyzer before contacting either your Roche service representative or technical support. Spillage Malfunction due to spilled liquid NOTICE Any liquid spilled on the analyzer may result in malfunction or damage.
Check your analyzer for suspicious activity and report any suspected compromise immediately to your local Roche representative. Update to latest software versions provided by Roche as soon as possible. Read and follow the recommendations and advices written in the safety chapter.
The label and its definition is listed below according to its location on the analyzer. If the label is damaged, it must be replaced by Roche Service representatives. For replacement labels, contact your local Roche representative. Figure 1-1...
These items must be disposed of via designated collection facilities appointed by government or local authorities. For more information about disposal of your old product, please contact your city office, waste disposal service or your Roche representative. Constraint: It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not.
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Multiplate® analyzer 2 Installation Table of contents Installation In this chapter, the installation of the analyzer is described. In this chapter Chapter Setting up the analyzer ......................29 Unpacking the analyzer .......................30 Installing the analyzer......................31 Setting up the software ......................34 Recommendations and limitations................34 Windows setup tasks .....................35...
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2 Installation Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
Multiplate® analyzer 2 Installation Setting up the analyzer Setting up the analyzer Please read the following information carefully before attempting to use the analyzer for the first time. To set up the analyzer perform the following steps: 1. Unpack all items.
Place the analyzer on a clean flat surface and remove the protective cover from the analyzer and the reagent holder. Check off the delivery contents using the following list. If there are items missing or damaged, immediately contact your Roche Service representative.
The printer cable is connected later during printer installation. Installing the printer (p. 48) Figure 2-2 Connecting the keyboard, mouse, and barcode reader 5 Connect the Roche-provided firewall, using the Ethernet cable. Figure 2-3 Connecting the Roche-provided firewall 6 Connect the analyzer to the mains power.
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2 Installation Multiplate® analyzer Installing the analyzer Electric shock and analyzer damage due to use of unearthed connection Without the protective earth wire the analyzer is not earthed and safe operation cannot be guaranteed. WARNING Do not plug the analyzer into a non-earthed socket.
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Multiplate® analyzer 2 Installation Installing the analyzer 10 Fix the holder to the analyzer using two Allen 8 mm screws. Figure 2-7 Fixing the holder 11 Thread the cable through the guide ring to fix it to the side of the analyzer.
Due to the enormous amount of software applications available it is impossible for Roche to validate the impact of all software that could be installed on the analyzer. Software installation on the analyzer must therefore be restricted to tools required, and must follow the guidelines described in this manual.
Multiplate® analyzer 2 Installation Setting up the software Windows setup tasks The following sections deal with language related setup tasks and describe how to define the system time. Adjusting the system language The analyzer in its standard version is equipped with an English keyboard layout (US international).
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2 Installation Multiplate® analyzer Setting up the software 4 In the Location tab, select France. Figure 2-10 Defining the location 5 In the Keyboards and Languages tab, select français as display language. Figure 2-11 Defining text entry options 6 Choose the Change keyboards button.
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Multiplate® analyzer 2 Installation Setting up the software 7 In the Default input language panel, select French (France) - French. Figure 2-12 Choosing the available keyboard layouts If you choose the OK button, the Region and Language window will be displayed again.
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2 Installation Multiplate® analyzer Setting up the software 9 The Change Regional Options window is displayed. Choose the Apply button to apply the changes made so far. Figure 2-14 Changing regional options 10 The User Account Control window is displayed. Choose the Yes button. Select French (France) from the drop-down list and choose the OK button.
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Multiplate® analyzer 2 Installation Setting up the software 3 In the Formats tab, select French from the drop-down list. Figure 2-17 Defining the format options 4 In the Location tab, select France. Figure 2-18 Defining the location Roche Diagnostics Operator’s Manual · Version 3.0...
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2 Installation Multiplate® analyzer Setting up the software 5 In the Keyboards and Languages tab, select français as display language. Figure 2-19 Defining text entry options 6 Choose the Change keyboards button. The Text Services and Input Languages window is displayed.
Multiplate® analyzer 2 Installation Setting up the software 9 Choose the OK button in the Region and Language window. 10 Restart the analyzer. Troubleshooting system language issues The keyboard is different from the The Windows 7 MUI version supports the following languages:...
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2 Installation Multiplate® analyzer Setting up the software Figure 2-22 German keyboard layout Figure 2-23 English keyboard layout Figure 2-24 Spanish keyboard layout Roche Diagnostics Operator’s Manual · Version 3.0...
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Multiplate® analyzer 2 Installation Setting up the software Figure 2-25 French keyboard layout Figure 2-26 Italian keyboard layout Figure 2-27 Polish keyboard layout Roche Diagnostics Operator’s Manual · Version 3.0...
2 Installation Multiplate® analyzer Setting up the software Figure 2-28 Swedish keyboard layout Adjusting the system time To adjust the system time 1 Switch on the analyzer and log on to the Windows operating system as administrator. For details, see Passwords for operating system (p. 149) 2 Choose Start >...
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Multiplate® analyzer 2 Installation Setting up the software 6 Choose Start > Control Panel > Region and Language. The Region and Language window is displayed. 7 On the Formats tab, select the preferred time format, for example select English (United States).
2 Installation Multiplate® analyzer Installing the electronic pipette Installing the electronic pipette When using the electronic pipette the first time you have to insert the battery into the electronic pipette, connect the electronic pipette to the analyzer, and start the analyzer and monitor.
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Multiplate® analyzer 2 Installation Installing the electronic pipette 4 Switch on the analyzer and the monitor. Switching on the analyzer activates the display of the electronic pipette and a countdown from 9 to 0 is performed. After the countdown is finished, bLo is displayed in the display of the electronic pipette.
To copy the printer driver from the USB storage device Perform this task if there is no pre-installed printer driver file on the analyzer. Contact your Roche Service representative to obtain the driver. 1 Switch on the analyzer and log on to the Windows operating system as administrator.
Multiplate® analyzer 2 Installation Installing the printer 2 Open Windows Explorer and navigate to C:\Installer\Driver\Printer. 3 Create a new sub-folder and name it according to the printer name to be installed and copy the appropriate printer driver file inside the folder.
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2 Installation Multiplate® analyzer Installing the printer 4 The window displayed next depends on your printer and driver type. Do one of the following: If a Welcome window is displayed, follow the instruction by making sure to have all other applications closed. Choose the Next button to continue.
Multiplate® analyzer 2 Installation Installing the printer A test page is printed on the printer. 11 The window displayed next depends on your printer and driver type. Confirm the final printer installation window by choosing the OK button. The window displays options like Return & Recycling or an information is displayed, telling you that the setup is now complete.
2 Installation Multiplate® analyzer Verifying the installation 2 Select the printer you have just installed (e.g. HP LaserJet Professional P1102) and choose the Print button to confirm it. Figure 2-35 3 Choose Print > Print test page to check if the selected printer is working.
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3 Overview Table of contents Overview In this chapter, you find general information on the analyzer. In this chapter Chapter Multiplate technology ......................55 Components..........................56 Electronic pipette .........................58 Operating elements......................59 Technical specification ......................62 Technical specifications of the analyzer ..............62 Technical specifications of the pipette.................63 Consumables and accessories .....................64...
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3 Overview Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
Multiplate® analyzer 3 Overview Multiplate technology Multiplate technology The analyzer is a platelet function analyzer based on impedance aggregometry. Two pairs of electrodes are immersed into the stirred blood sample. When platelets aggregate they adhere to the electrodes and change the electrical resistance (or impedance) between them.
3 Overview Multiplate® analyzer Components Components The analyzer is equipped with an internal computer system and proprietary software for data recording and processing. At the rear, several ports are available for connection to network, printer, etc. USB port USB ports for printer, mouse, barcode...
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Multiplate® analyzer 3 Overview Components The following table provides short descriptions of the main components. Component Description A USB port Use the USB port for data import and export using a USB flash drive. Pipette cable connection Push the plug of the pipette cable firmly into the jack until it snaps in.
3 Overview Multiplate® analyzer Electronic pipette Electronic pipette The electronic pipette is a remote controlled, battery-operated piston-stroke pipette used on the analyzer. The electronic pipette uses the air-displacement principle for the pipetting of aqueous solutions with an average density and viscosity.
Multiplate® analyzer 3 Overview Electronic pipette Operating elements The electronic pipette is a remote controlled, battery-operated, piston-stroke pipette, which has been optimized for ergonomic operation. Display Tip cone Up, Down, MENU, and ENTER buttons Pipette cable to analyzer Start button...
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3 Overview Multiplate® analyzer Electronic pipette Key functions Up button Confirmation / Activation button Restarts the actual step in Auto Pipette mode. Start button D Down button Go to the next step in Auto Pipette mode. Figure 3-4 Key functions The MENU and ENTER buttons can only be used to perform the reference run when the pipette is not connected to the analyzer.
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Multiplate® analyzer 3 Overview Electronic pipette Figure 3-6 Tip ejection Treat tips as biohazardous waste. Roche Diagnostics Operator’s Manual · Version 3.0...
3 Overview Multiplate® analyzer Technical specification Technical specification Technical specifications of the analyzer Physical dimensions Width 45 cm Depth 32 cm Height 10 cm Weight 9.5 kg Power requirements Line voltage 100–240 V Line frequency 50 / 60 Hz Power consumption...
Limitations of use The electronic pipette on the analyzer is intended for the pipetting of liquids within the following limitations: The temperature of the pipette should be between 15 to 40 °C. Consult your Roche representative for use in temperatures outside of this range. Vapor pressure up to 500 mbar Viscosity: 260 mPa s (260 cps) The electronic pipette is only to be used on the analyzer.
Consumables and accessories Malfunction due to use of non-approved accessories NOTICE Using non-approved consumables may result in malfunction. Only use consumables and accessories approved by Roche. For ordering consumables and accessories, contact your Roche representative. Roche Diagnostics Operator’s Manual · Version 3.0...
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Using keyboard shortcuts .....................67 Main screen ...........................69 Menu bar .........................69 Status bar .........................70 Quick access buttons......................70 Channel display ......................70 Menu options ........................76 Multiplate menu ......................76 About .........................76 Lock/unlock channels .....................76 Start electronic QC ....................76 Exit ..........................76 Measurements menu......................77 Start measurements ....................77 Stop measurements....................77...
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4 Software Multiplate® analyzer Table of contents Save analyzer configuration..................90 Print menu ........................90 Select printer......................90 Print ...........................91 Print screenshot......................91 Print test page......................91 Configuration menu ......................92 Change password (level 1) ..................92 Change password (level 2) ..................93 Edit analyzer configuration ..................93 Select language ......................94 Edit tests ........................94...
Multiplate® analyzer 4 Software Introduction Introduction The analyzer is designed to ensure ergonomic, efficient, and safe handling. Using keyboard shortcuts You can enter information and invoke commands using the keyboard and mouse. Commands can also be invoked using keyboard shortcuts.
Channel display The channel display shows data, graphics, patient and sample ID, and test identification for each channel. Menu bar The menu bar consists of the menus Multiplate® , Measurements, Tools, Print, and Configuration. For further information, see Menu options (p. 76).
The status bar shows the current temperature of the measurement block. If the temperature is out of range and a measurement is started, the operator is asked whether to proceed against Roche’s recommendation. In addition, the status bar informs the operator about possible analyzer errors or service messages.
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Multiplate® analyzer 4 Software Main screen Channel number Status icon Information panel (data alarm, patient ID, Graphic window test name, start time, and run time) AUC parameter of the measurement Scaling buttons D AUC bar with reference range Internal control, aggregation, and velocity...
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AUC results against the programmed reference and target range. The bars can be enabled for each test in the Edit Multiplate tests window using the functions Show reference range for AUC and Show target range for AUC.
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Multiplate® analyzer 4 Software Main screen Lower end of reference range Upper end of reference range Current AUC measurement result D Inhibited platelets show the black bar below the lower end of the reference range Figure 4-4 Reference range, aggregation below the reference range For further information related to the AUC bars see General analyzer configurations (p.
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4 Software Multiplate® analyzer Main screen Saving measurement results. Measurement has been completed without data alarm. Measurement has been completed with a data alarm. Measurement has been completed with a data alarm. The data alarm was confirmed by the user.
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Multiplate® analyzer 4 Software Main screen Quality control parameters This line displays the aggregation curve QC (internal control) parameters correlation coefficient (CC) and deviation from mean (DIF). This represents the correlation of the two measurements performed in each test cell.
Actual values from both sensors in each of the five channels are validated by comparison with a reference value defined by Roche. To ensure the validity of the measurement system, Roche recommends that an electronic control measurement be performed before the first measurement of the shift or in accordance with local standards.
Multiplate® analyzer 4 Software Menu options Measurements menu Figure 4-10 Commands in the Measurements menu Start measurements Measurements > Start measurements Use Start measurements to start processing when working with manual pipetting. Select individual channels, or use All free channels to select all channels that do not contain a measurement (cleared channels).
4 Software Multiplate® analyzer Menu options Clear channels Measurements > Clear channels Use Clear channels to delete all information associated with a channel. You need to clear channels that contain stopped measurements before you can start a new measurement. Select individual stopped channels, or use Stopped channels to clear all stopped channels.
Multiplate® analyzer 4 Software Menu options Autopipette Measurements > Autopipette The electronic pipetting function simplifies and standardizes the measurement process, particularly sample handling, sample assignment, and pipetting. The operator is guided through the procedure by several “next pipette step” instructions.
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4 Software Multiplate® analyzer Menu options Process measurement series This screen provides an overview of the current processing and it also provides instructions on how to proceed. Figure 4-17 Process measurement series window The right part of the window explains basic pipette operating instructions. The Pipetting instruction panel (A) contains instructions on how to proceed.
Multiplate® analyzer 4 Software Menu options Worklist Measurements > Worklist The Worklist window is used when the analyzer is connected to an LIS. Use the worklist to do the following: Download orders from the LIS. Assign orders to channels. Start autopipette measurements.
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4 Software Multiplate® analyzer Menu options Order status The following icons are used to indicate the order status: LIS order successfully downloaded. Measurement not started. LIS order was discarded. Measurement has been started. Measurement progress is indicated. Saving measurement results.
Multiplate® analyzer 4 Software Menu options See LIS configuration (p. 95) It is possible to send results from manually created measurements to the LIS. To do this, you must assign a patient ID and a sample ID to the measurements before sending.
4 Software Multiplate® analyzer Menu options Tools menu Figure 4-20 Commands in the Tools menu Start timer, Stop timer Tools > Start timer, Tools > Stop timer Use this function to start the standard 3-minute incubation time required before you can add reagent to the sample.
Roche Service representative for analysis. The image file is saved in PNG format to the data folder C:\Multiplate\Data\Screenshots. The Screenshots folder is subdivided into folders for each year, month, and day when a screenshot was made.
Figure 4-22 Export measurements window Export directory The export directory is: C:\Multiplate\Data\Export. Number of columns per worksheet Enter the maximal number of columns per worksheet. If a worksheet exceeds 250 columns you need Microsoft Office 2007/Open Office V3 or higher to open the worksheet.
Figure 4-23 Export graphics window Export directory The export directory is: C:\Multiplate\Data\Export Graphics. Show curve as area Enable this option to show the measurements as filled curves. Zoom factor Use the zoom factor to optimize visualization of curves with low aggregation responses (Level 50 / 75 AU) and a better display of high aggregation curves.
4 Software Multiplate® analyzer Menu options Liquidtrans Tools > Liquidtrans The Liquidtrans function facilitates reconstitution of reagents and preparation of reagent aliquots using the electronic pipette. Figure 4-24 Liquidtrans window You can pipette between 10 μL and 300 μL. If the requested volume is greater than 300 μL incremental steps must be performed, e.g.
Multiplate® analyzer 4 Software Menu options Show analyzer status Tools > Show analyzer status Impedance raw data for all five channels are displayed for troubleshooting purpose. Each channel has two sensors. Figure 4-25 Show analyzer status window See Viewing detailed measurement data (p. 132).
Use this function to print the current analyzer configuration. Save analyzer configuration Tools > Save analyzer configuration Use this function to save the current analyzer configuration to a text file. The file is saved to the following directory: C:\Multiplate\Config\History Print menu Figure 4-27 Print menu Select printer Print >...
Print test page Print > Print test page Use this function to print a test page on the printer. Roche recommends to periodically check the printing function and the quality of the printout by printing a test page. Roche Diagnostics...
4 Software Multiplate® analyzer Menu options Configuration menu Figure 4-30 Configuration menu To access the configuration functions, the level 1 or level 2 password must be entered. Figure 4-31 Enter password window Level 1 password Users with a level 1 password can access and edit most of the configuration functions...
Use this function to enable the tests for your analyzer, to customize its settings, and to create new user defined tests. Figure 4-36 Edit Multiplate tests window See Editing test parameters (p. 158). Roche Diagnostics Operator’s Manual · Version 3.0...
Configuration > Configure data alarms This function is designed for configuring the data alarm parameters. Because the data alarm parameters affect quality control, Roche recommends not to change any of them. The precision and correlation of duplicate sensor measurements are monitored electronically.
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4 Software Multiplate® analyzer Menu options A minimum threshold of 30 AU is set for the data alarms of duplicate sensor measurements. Measurement results below this threshold are not automatically controlled. This threshold value can be manually adjusted. The reference values are set by default at 0.98 for the CC and 20% maximum deviation from the mean (DIF).
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Viewing detailed measurement data ................ 132 Deleting result data ..................... 133 Deleting orders from the worklist................... 134 Reconstituting reagents and preparing aliquots............135 Multiplate system control....................137 Electronic control measurements ................138 Data alarms ........................141 Dealing with failed internal control measurements......... 141 Data alarm display ....................
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5 Operation Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
CAUTION Do not open or modify the analyzer unless expressly authorized by Roche. Incorrect results due to operating errors by the user Errors in operating the software and analyzer may lead to incorrect results. When...
5 Operation Multiplate® analyzer Starting the analyzer Starting the analyzer To start the analyzer 1 Push the blue power push-button on the right side of the analyzer. Figure 5-1 Power button on analyzer 2 Log on to the Windows operating system as operator or administrator.
Multiplate® analyzer 5 Operation Using the electronic pipette Using the electronic pipette The following procedures show you the general handling of the electronic pipette. To use the electronic pipette for pipetting This procedure shows you the general handling of the electronic pipette.
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5 Operation Multiplate® analyzer Using the electronic pipette To avoid the intake of air, leave the tip immersed into the liquid for approximately one second. The arrow in the display points upwards to indicate aspiration of liquid. Figure 5-4 Aspiring liquid, display When aspiration is completed, the arrow in the display points downwards to indicate that the pipette is ready for dispensing.
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Multiplate® analyzer 5 Operation Using the electronic pipette 5 Press the Start button to dispense the liquid into the test cell or reagent vial. Figure 5-6 Start dispensing The arrow in the display points downwards to indicate the dispensing of liquid.
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5 Operation Multiplate® analyzer Using the electronic pipette 6 Hold the pipette over a suitable waste container and press the Eject button to eject the tip into the waste container. Figure 5-8 Tip ejection Roche Diagnostics Operator’s Manual · Version 3.0...
5 Operation Performing a measurement Performing a measurement To ensure the validity of the measurement system, Roche recommends performing an electronic control measurement before the first measurement of a shift or in accordance with local standards. For details, see Electronic control measurements (p. 138).
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5 Operation Multiplate® analyzer Performing a measurement 2 Search the worklist for the orders you want to run. Choose a column header to sort the worklist. Choose the Filter button and select a filter criteria to filter the worklist. Select an entry from the Hide old items drop-down list, to hide orders that are older then the specified number of days.
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5 Operation Performing a measurement Ensure that the magnetic stirrer is inside the test cell and rotates. If the magnetic stirrer does not rotate, lock the affected channel and contact your Roche Service representative. See Lock/unlock channels (p. 76). 7 Connect the sensor cable(s) to the test cell(s).
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5 Operation Multiplate® analyzer Performing a measurement 9 Press the Start button on the electronic pipette. In the Process measurement series window, the next step is indicated. 10 Carefully follow the instructions in the Process measurement series window. Figure 5-14...
When measurements are not yet started, canceling the electronic pipetting also will delete all input data. Roche recommends to use the electronic pipette. Use manual pipetting only in case of problems with the electronic pipette.
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5 Operation Multiplate® analyzer Performing a measurement Pre-analytical sample handling Allow a standby time of at least 30 or 60 minutes (depending on reagent and sample tube type) after collection when analyzing whole blood samples. If whole blood samples are analyzed earlier, low result recovery may occur.
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Figure 5-18 Placing test cells Ensure that the magnetic stirrer is inside the test cell and rotates. If the magnetic stirrer does not rotate, lock the affected channel and contact your Roche Service representative. See Lock/unlock channels (p. 76). 6 Connect the sensor cable(s) to the test cell(s).
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5 Operation Multiplate® analyzer Performing a measurement Figure 5-20 Process measurement series window The right part of the window explains basic pipette operating instructions. The lower part shows the pipette steps for each channel. An arrow indicates the current pipette step (B). Subsequent steps are marked with a dot, executed steps with a tick.
Performing measurements using manual pipetting Perform the following procedures in the order they are described. Roche recommends to use the electronic pipette. Use manual pipetting only in case of problems with the electronic pipette. Pre-analytical sample handling Allow a standby time of at least 30 or 60 minutes (depending on reagent and sample tube type) after collection when analyzing whole blood samples.
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Figure 5-23 Placing test cells Ensure that the magnetic stirrer is inside the test cell and rotates. If the magnetic stirrer does not rotate, lock the affected channel and contact your Roche Service representative. See Lock/unlock channels (p. 76). 2 Connect the sensor cable(s) to the test cell(s).
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Multiplate® analyzer 5 Operation Performing a measurement 8 Start each individual measurement immediately after adding the activator by choosing the Start test button. The Start measurements window is displayed. Figure 5-25 Starting measurements 9 Do one of the following: Select All free channels to start the measurement on all channels that are free Select one or more channels to start individual channels.
5 Operation Multiplate® analyzer Performing a measurement 15 Wait until the measurements are complete and saved. The status icons below the graphic windows change and the runtime stops counting and shows 6'00''. 16 Print the result. 17 Clear the channels that contain measurements.
2 Select the channels whose results you want to print or select All channels or All completed channels, then choose the Print button. The printer starts printing the measurements one below the other, and a screenshot (PNG file) is saved automatically in: C:\Multiplate\Data\Screenshots. See also Screenshots (p. 131). Figure 5-29...
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The IrfanView Thumbnails window is displayed. Figure 5-31 Thumbnail view in IrfanView application The results are located in: C:\Multiplate\Data\Graphics. Data are sorted chronologically. 3 Select up to 5 measurements of your choice. 4 Right-click the selection and choose Create contact sheet from selected files…...
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Multiplate® analyzer 5 Operation Performing a measurement 5 Enter the values as shown below. Figure 5-32 Creating a contact sheet Select the dimension that agrees with your printer paper. If required you may enter your laboratory ID using the Footnote field.
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5 Operation Multiplate® analyzer Performing a measurement 6 Click Create. The contact sheet is generated. Figure 5-33 Contact sheet Roche Diagnostics Operator’s Manual · Version 3.0...
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Multiplate® analyzer 5 Operation Performing a measurement 7 Choose Ctrl+P or File > Print to print. The Print Preview window is displayed. Figure 5-34 Print preview in IrfanView application 8 In the Print size panel, select Best fit to page.
The entered name is added to the standard image name (date and time when the screenshot was taken). 3 Choose the Accept button to save the file. An image file is saved to the data folder: C:\Multiplate\Data\Screenshots. See also Screenshots (p. 131). Roche Diagnostics...
Multiplate® analyzer 5 Operation Performing a measurement Clearing channels Clear a channel to delete the measurement data of the selected channel so that a new measurement can be started. You can clear finished and manually stopped channels. Clearing a channel does not affect saved results.
5 Operation Multiplate® analyzer Performing a measurement Exporting results You can accumulate multiple results in one table. The measurement data for a definable period of time can be exported as XML (Extensible Markup Language) files. These data can then be edited for example in Microsoft Excel or OpenOffice Calc.
Multiplate® analyzer 5 Operation Performing a measurement 4 Choose the Export measurements in selected time frame. button. The data are exported to files in the Export folder. (See Export (p. 130)). With each export four XML files are generated: Aggregation, Rawdata Sensor 1, Rawdata Sensor 2, and Velocity.
5 Operation Multiplate® analyzer Performing a measurement 2 Define the start and end date of the period for which you want to export the graphics. The calendar is displayed in the language selected in the regional settings of the Windows operating system.
Multiplate® analyzer 5 Operation Performing a measurement 2 Select an order that you want to send to the LIS. 3 Place the cursor in the Sample ID and read the sample barcode using the hand- held barcode reader. 4 Place the cursor in the Patient ID field and read the patient barcode using the hand-held barcode reader.
The following sections describe where the various result data are stored. Data folder Measurement data are saved in graphic and XML files. All measurement data is stored in: C:\Multiplate\Data. The stored data is organized in date folders (Year/Month/Day). Figure 5-42...
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Multiplate® analyzer 5 Operation Result handling Export Graphics The Export Graphics sub-folder contains all data in PNG format that were stored using the Export graphics function. Figure 5-44 Storage location of exported graphics Graphics The Graphics sub-folder contains all measurements as individual graphic files. The data include the parameters.
5 Operation Multiplate® analyzer Result handling Viewing detailed measurement data You can view the current measurement raw data with calibration and correction factors for all channels. To view the raw data of the current measurements 1 Choose Tools > Show analyzer status.
Make sure that the results and graphics are exported or sent to the LIS before they are deleted. Damage to the analyzer due to file deletion If you delete data outside of the result data folder (C:\Multiplate\Data) the system might irreversibly be damaged. CAUTION Delete only data within the result data folder.
5 Operation Multiplate® analyzer Deleting orders from the worklist Deleting orders from the worklist Delete orders in the worklist regularly. When you delete an order, the corresponding results are not deleted. Only new orders (measurement not yet started) and completed orders (result already sent to LIS) can be deleted.
Multiplate® analyzer 5 Operation Reconstituting reagents and preparing aliquots Reconstituting reagents and preparing aliquots The Liquidtrans function helps you to efficiently reconstitute reagents and prepare reagent aliquots. Dispensing error due to inappropriate operation Pressing any key on the electronic pipette during initialization of the pipette may cause dispensing errors and consequently lead to incorrect results.
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5 Operation Multiplate® analyzer Reconstituting reagents and preparing aliquots 2 Enter the required volume (A). You can pipette between 10 μL and 300 μL with one action. If the requested volume is greater than 300 μL incremental steps must be performed, e.g. 1000 μL would require four steps (300+300+300+100 μL).
Multiplate® analyzer 5 Operation Multiplate system control Multiplate system control To ensure the validity of the measurement system, quality control measurements must be performed regularly. You must always follow the applicable government regulations and local guidelines for quality control. Control material used for the quality control measurement should be as similar as possible according to the state of science and technology.
Multiplate® analyzer Multiplate system control Electronic control measurements Roche recommends performing an electronic control measurement before the first measurement of a shift or in accordance with local standards. The electronic control measures a fixed resistor that is internally connected to the parking positions of the 5 sensor cables.
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4 Check whether the results are within the ranges. If results fail to pass the electronic control criteria, the first step is to repeat the procedure. If the results continue to fail, contact your Roche Service representative for further advice.
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5 Operation Multiplate® analyzer Multiplate system control Figure 5-51 Failed results of electronic control In this situation, install the affected sensor cable on a different channel and then repeat the electronic control by choosing the Repeat electronic QC button. If the problem persists for the same channel, exclude the defective channels from further use by choosing the Lock faulty channels button.
Multiplate® analyzer 5 Operation Multiplate system control Data alarms Data alarms are displayed when internal checks fail during the measurement. This includes internal control measurements which are performed for each measurement when Enable data alarm is activated (Configuration > Configure data alarms).
5 Operation Multiplate® analyzer Multiplate system control 3 Do one of the following: Choose the Yes button to instantly clear the channel. The measurement is still saved but deleted is added to its filename. Choose the No button to record the result.
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Multiplate® analyzer 5 Operation Multiplate system control Data alarm Description Possible cause Remedy All measuring values The NaCl was not preheated. 1. Repeat the measurement making sure Decreasing curve are decreasing. All that NaCl is preheated. results (the AUC, 2. If the data alarm persists, contact aggregation and your Roche Service representative.
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5 Operation Multiplate® analyzer Multiplate system control Data alarm Description Possible cause Remedy The time between Additional software was installed on the 1. Check if additional software was Time interval two measuring analyzer affecting the measuring installed on the analyzer.
Stop all measurements and shut down the system. Do not use the power button to shut down the system. To shut down the analyzer 1 Choose Multiplate > Exit. (You can also click in the top right corner of the main screen.) A confirmation window is displayed.
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5 Operation Multiplate® analyzer Shutting down the analyzer Roche Diagnostics Operator’s Manual · Version 3.0...
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Multiplate® analyzer 6 Configuration Table of contents Configuration In this chapter, you find information and instructions on configuration tasks. In this chapter Chapter Passwords ........................... 149 Setting up a printer......................150 Adjusting the internal control parameters for data alarms.......... 151 Configuring the analyzer....................
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6 Configuration Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
6 Configuration Passwords Passwords Passwords for Multiplate software All configuration options are password protected. To change the options enter the password to get access. Make sure that only authorized and trained personnel can access the configuration options. Once entered a password, all options that are accessible with that password level stay accessible until the next shutdown of the software.
6 Configuration Multiplate® analyzer Setting up a printer Setting up a printer To set up a printer 1 Choose Print > Select printer. The generic Windows Print window is displayed. Figure 6-1 Configuring a printer 2 Select a printer from the list.
Measurement results below this threshold are not automatically controlled. This threshold value can be manually adjusted. Roche recommends that the internal control is not applied to measurements with low aggregation results (i.e. < 30 AU) because of the higher relative deviations between the two curves.
6 Configuration Multiplate® analyzer Configuring the analyzer 4 If required, adjust the internal control parameters. Adjust internal control parameters only if you use the analyzer for research use! 5 Choose the Accept button to adopt the changes. When the next measurement is started, the new values will be applied.
Multiplate® analyzer 6 Configuration Configuring the analyzer Display and printing options Configuration > Edit analyzer configuration > Display/Print The printout and the measurement display can be modified using various configurations. Figure 6-4 Display/Print tab Dashed grids on the screen If these options are selected, a grid is displayed in the graphic window on the screen Dashed grids on the printout and on the printout.
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Synchronized graphic scaling Use this option to synchronize the graphic scaling for all channels on the main screen. When you change the scaling for one graphic, all other channels will be changed accordingly. Select the unit for the AUC value (AU*min or U). Roche recommends to use the unit Display format of the AUC parameter U for the AUC parameter.
Multiplate® analyzer 6 Configuration Configuring the analyzer 10 AU*min = 1 U General analyzer configurations Configuration > Edit analyzer configuration > Configurations The options on the Configurations tab can be changed with a level 2 password only. Figure 6-9 Configurations tab Max.
6 Configuration Multiplate® analyzer Configuring the analyzer Acoustic signal Configuration > Edit analyzer configuration > Acoustic signal Figure 6-10 Acoustic signal tab Use the integrated beeper of the Do not change the default setting. mainboard for the acoustic signal The availability of this option depends on the hardware revision of your analyzer.
Changing the language The software is available in at least 10 different languages. For the availability of languages that are not listed below, contact your Roche Service representative. Incorrect results due to wrong test parameters after a language change All test parameters are language dependent. Therefore, when changing the language, all test parameters will change, too.
User defined tests are language dependent, too and must be reentered after a language change. Make sure that user defined tests with non-Roche reagents are set up with care and are approved by appropriate methods. Roche cannot made liable for any harm that results from the use of non-Roche reagents on the analyzer.
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150 seconds counted from the incubation start. Test duration Duration of the test in minutes. Default test duration is 6 minutes. Enter a value between 3 and 30 minutes. Roche recommends not to change the default pipetting speed. Pipetting aspiration speed Pipetting dispensing speed Default value is 5.
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6 Configuration Multiplate® analyzer Editing test parameters Figure 6-13 Upper and lower limit of the reference range for AU Select Show reference range for Vel to show the entered reference range for velocity in brackets after the current velocity value AU/min.
Multiplate® analyzer 6 Configuration LIS configuration LIS configuration Configuration > LIS configuration Figure 6-15 LIS configuration window Send automatically Select this option if the results should automatically be sent to the LIS after the channel is cleared. If this option is disabled, the results have to be sent manually to the LIS.
6 Configuration Multiplate® analyzer Electronic QC Electronic QC Configuration > Electronic QC The Electronic QC function can only be accessed with a level 2 password. Figure 6-16 Electronic QC window Limit for the deviation between Enter the maximum allowed deviation between the actual electronic control measurement and the reference value.
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Multiplate® analyzer 7 Maintenance Table of contents Maintenance In this chapter, you find instructions on how to perform the important maintenance tasks. Chapter In this chapter Overview ..........................167 Safety..........................167 Cleaning and disinfecting the analyzer ................168 Maintenance and cleaning of the electronic pipette ............. 169 Inserting or changing the battery................
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7 Maintenance Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
There are no components inside the analyzer that need maintenance by the operator. If any operational faults occur contact your Roche Service representative. Periodic maintenance (carried out by a Roche Service representative) is not required for the analyzer. The following maintenance actions should be performed regularly:...
7 Maintenance Multiplate® analyzer Cleaning and disinfecting the analyzer Cleaning and disinfecting the analyzer Surfaces, which may come into contact with potentially hazardous materials, must be disinfected according to local regulatory standards. To clean the synthetic surface of the analyzer 1 Use a cloth moistened with mild detergent.
Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette Maintenance and cleaning of the electronic pipette Regular maintenance of the electronic pipette is recommended to ensure trouble-free operation. The following maintenance actions should be performed regularly: Maintenance task...
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7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 2 Unplug the pipette cable to the analyzer. Figure 7-1 Unplugging the pipette 3 Open the cover of the battery compartment. Figure 7-2 Opening battery compartment 4 Remove the old battery when present.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette 6 Close the cover of the battery compartment. Figure 7-4 Closing battery compartment After replacing the battery, a reference run becomes automatically due. 7 Perform a reference run. For details on performing a reference run, see Performing a reference run (p. 180).
7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette After connecting the pipette cable, the battery must be fully charged, when it is used for the first time. Charging is done automatically when the pipette is connected to the analyzer and the analyzer is switched on. The charging time can be up to 3.5 hours.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette 2 Unplug the pipette cable to the analyzer. Figure 7-8 Unplugging the pipette 3 Remove the tip cone filter from the pipette. Figure 7-9 Removing the filter 4 Unscrew the pipette shaft from the grip.
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7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 6 Unscrew the upper part of the ejector from the pipette shaft. Figure 7-11 Unscrewing upper part of ejector 7 Pull the shaft out of the lower part of the ejector.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette 8 Unscrew the retention sleeve. Figure 7-13 Unscrewing retention sleeve The piston and piston guide remain connected with the retention sleeve. 9 Remove the spring and seal. Figure 7-14...
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7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 10 Clean the parts shown with water followed by isopropanol and then rinse with distilled water. Figure 7-15 Pipette parts 11 Allow the parts to dry (max. 120 °C).
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette 14 Insert the spring and seal. Figure 7-17 Inserting spring with seal 15 Screw on the retention sleeve. (Hand-tight is sufficient). Figure 7-18 Screwing on retention sleeve Roche Diagnostics...
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7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 16 Insert the lower part of the ejector onto the shaft. Figure 7-19 Inserting lower part of ejector 17 Screw the upper part of the ejector onto the pipette shaft.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette 18 Screw the pipette shaft into the grip. (Hand-tight is sufficient.) Figure 7-21 Screwing pipette shaft on grip 19 Insert a new tip cone filter into the pipette. Figure 7-22 Inserting a new filter 20 Perform a reference run.
7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 21 Plug the pipette cable into the electronic pipette. Figure 7-24 Connecting pipette 22 Start the analyzer. See Starting the analyzer (p. 102) Switching on the analyzer activates the display of the electronic pipette and a countdown procedure (from 9 to 0) is performed.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette Figure 7-25 Unplugging the pipette 2 Simultaneously press the MENU and ENTER buttons. Figure 7-26 Initiating reference run mode On screen, the rEF text indicates that the pipette is in reference run mode.
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7 Maintenance Multiplate® analyzer Maintenance and cleaning of the electronic pipette 3 Press the Start button once to start the reference run. Figure 7-28 Starting reference run A noise can be heard, clearly indicating the function is being performed. When the reference run is finished, the display automatically returns to the normal view.
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Multiplate® analyzer 7 Maintenance Maintenance and cleaning of the electronic pipette Switching on the analyzer activates the display of the electronic pipette and a countdown procedure (from 9 to 0) is performed. bLo is displayed in the display of the electronic pipette.
Calibration service ISO 9001 and GLP-guidelines require regular examinations of your volumetric instruments. Roche recommends checking the volume of the electronic pipette according to your local standards. Contact your local Roche representative for details about the calibration service. Roche Diagnostics...
7 Maintenance Checking the proper functioning of the printer Checking the proper functioning of the printer Roche recommends to periodically check the printing function and the quality of the printout. To check the proper functioning of the printer 1 Choose Print > Print test page.
7 Maintenance Multiplate® analyzer Checking the temperature Checking the temperature To check the analyzer temperature 1 Choose Tools > Show analyzer temperatures. The temperature menu displays the actual temperature of three sensors that are located underneath the measurement block. The internal temperature of the analyzer is also displayed.
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Multiplate® analyzer 8 Troubleshooting Table of contents Troubleshooting In this chapter, you find information on how to deal with exceptional situations. In this chapter Chapter Dealing with exceptional situations................191 Situations associated with individual analyzer components ......... 191 Messages ........................193 Situations associated with quality controls ..............
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8 Troubleshooting Multiplate® analyzer Table of contents Roche Diagnostics Operator’s Manual · Version 3.0...
Situations associated with individual analyzer components Messages Situations associated with quality controls The result of the measurement is not plausible Contact your Roche Service representative if a problem cannot be resolved. Situations associated with individual analyzer components Situation Description Cause...
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If the problem persists contact your Roche Service representative. For 2.: Contact your Roche Service representative. The software is acting very slow The reaction time of the Possible cause is the installation Remove any 3rd party software...
Avoid direct before the start of a sunlight. measurement. For 2.: Contact your Roche Service representative. Status bar indicates e.g.: The temperature is outside the 1. Preheating phase too short. For 1.: Wait for the preheating Measurement block specified range.
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8 Troubleshooting Multiplate® analyzer Dealing with exceptional situations Stirring module messages Situation Description Cause Remedy Message window The stirring control The stirring control might be defective. 1. Choose the No button to stop the shows The stir bar sends an error or is measurement.
1, not as contact your Roche Service recommended onto the representative. surface of solution 1? For 5.: Contact your Roche 4. Air bubbles at the sensor Service representative. unit of the test cell? 5. Wrong calibration. The result of the LQC is below 1.
8 Troubleshooting Multiplate® analyzer Dealing with exceptional situations The result of the measurement is not plausible Situation Description Cause Remedy The result of the Unexpectedly low result without 1. Clotted blood? For 1.: Inspect the blood sample measurement is not the influence of platelet inhibiting 2.
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The curves are looking like waves The power supply is old and needs Contact your Roche Service beginning with channel 1. At the to be replaced urgently because it representative. end all channels are affected. At will soon be faulty.
Charge battery without operating until battery is fully charged (battery icon stops flashing). Replace battery if needed. Faulty electronic component Contact your Roche Service representative. Pipette does not react Faulty electronic component Contact your Roche Service representative. Pipette does not react...
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