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PN A51387A

B

3-35

Installing and Calibrating an Aperture Tube

Running a Concentration Control Sample

3

4.

In the Concentration Control window, enter the Lot Number, the Concentration Assay Value,
and the Expiration Date listed on the assay sheet.

5.

Click

(

Start

)

to begin the concentration control run.

6.

The Multisizer 4 software flushes the system and begins the run.

7.

When the run is complete, a second Concentration Control window opens and displays results.
The window displays a message that the concentration is low or high if the Analyzer
measurement deviates from the concentration control by 10% or more. If this occurs, contact
Beckman Coulter Service. For information on how to do this, see

Working with Field Service

on

page

.

8.

Click

(

Close

)

.

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Summary of Contents for Multisizer 4

Page 1: ...PN A51387AB March 2010 Beckman Coulter Inc 250 Kraemer Blvd Brea CA 92821 User s Manual Multisizer 4 Particle Analyzer ...

Page 2: ...ulter Inc All rights reserved No part of this document may be reproduced or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without prior written permission from Beckman Coulter Inc Find us on the World Wide Web at www particle com ...

Page 3: ...al Warnings xx Chemical Warnings xx Mechanical Warnings xx Fire Warnings xx Cautions xxi Electrical Cautions xxi Chemical Cautions xxi CHAPTER 1 Analyzer Overview 1 1 Overview 1 1 New Multisizer 4 Features 1 1 Bar Code Reader 1 1 Sample Platform Beaker and Accuvette Guides 1 1 Automatic Stirrer Positioning 1 1 Automatic Blockage Detection 1 2 Extended Dynamic Range 1 2 Multisizer 4 Components 1 2 ...

Page 4: ...1 13 Aperture Tubes 1 14 Handling Aperture Tubes 1 14 Cleaning the Aperture Tube Beakers and Accuvette STs 1 15 Cleaning the Analyzer 1 16 Pre Filtering the Electrolyte and Cleaning Fluid 1 17 Starting the Analyzer 1 18 Preparing the Analyzer for Sample Runs 1 18 CHAPTER 2 Software Overview 2 1 Opening the Multisizer 4 Software 2 1 Connecting the Software to the Analyzer 2 1 Connecting Analyzer an...

Page 5: ...tic noise levels 3 5 Reduce vibration 3 5 Block electrical interference 3 5 Pre Filtering the Electrolyte and Cleaning Fluid 3 5 Cleaning the Analyzer Prior to Using a Small Aperture 3 6 Cleaning System Components and Accessories 3 6 Small Aperture Noise Profiles 3 7 Using Appropriate Current and Gain Settings 3 9 Storing Small Aperture Tubes 3 9 Calibrating the Aperture 3 10 Choosing the Calibrat...

Page 6: ...e Names 4 4 Using File Name Template Codes 4 5 Using Unique Numbers in Analysis Files 4 6 Write Protecting Saved Analysis Files 4 6 Standard Operating Method Control Mode 4 6 Standard Operating Method Run Settings 4 8 Standard Operating Method Stirrer Settings 4 10 Copying Manual Stirrer Settings 4 11 Standard Operating Method Threshold Current and Gain 4 13 Using the Current Gain Tab in the Edit ...

Page 7: ...ical Category Names 5 17 Preferences Averaging and Trend 5 17 Preferences Export 5 19 Preferences Page Setup 5 20 Preferences Graph Options 5 21 Preferences Fonts and Colors 5 21 Preferences View Options 5 23 Reviewing Your Preferences Settings 5 24 Saving a Preferences File 5 25 Automatically Updating the Default Preferences File 5 26 CHAPTER 6 Analyzing a Sample 6 1 Analyzing a Sample 6 1 Analyz...

Page 8: ...Format 7 5 Blockage Monitors Column Format 7 6 Calculate Menu 7 6 Viewing Interpolations 7 6 Changing the Column Display 7 8 Viewing Statistics 7 8 Comparing Statistics to Sample Specifications 7 9 Comparing an Analysis to a Standard Run 7 9 Converting Pulses to Size 7 9 Converting Pulses to Size Between Cursors 7 11 Converting Pulses to Size for the Widest Distributions 7 11 Printing Report s for...

Page 9: ...Configuration Options 8 1 Security Modes and Configuration 8 1 Customizing Main Menus 8 3 Customizing Run Menus 8 5 Customizing Toolbars 8 7 Customizing the Status Panel 8 8 Customizing Sample Info Names 8 10 Customizing Recent File and Folder Lists 8 11 Selecting a New Folder from the Recent Folder List 8 12 Adding a Folder to the Recent Folders List 8 12 Customizing the Save Preferences Default ...

Page 10: ...g the Electrolyte and Waste Jars 9 13 Working with Field Service 9 15 Requesting Service and Technical Support 9 15 Identifying the Instrument 9 15 Updating Firmware and FPGA Software 9 16 Viewing the Instrument Schematic 9 17 Viewing the Error Log 9 18 Opening Service Mode 9 18 CHAPTER 10 Regulatory Compliance 10 1 Regulatory Compliance 10 1 Electronic Signatures 21 CFR Part 11 10 1 Electronic Re...

Page 11: ... ST Side 1 11 1 7 Reversing the Sample Platform 1 11 1 8 Proper Handling of a Small Aperture Tube 1 15 1 9 Cleaning an Aperture Tube 1 16 1 10 Closed Circuit Filtration System 1 17 3 1 Proper Handling of a Small Aperture Tube 3 4 3 2 Closed Circuit Filtration System 3 6 3 3 Cleaning an ST Aperture Tube with a Squeeze Bottle 3 7 3 4 Noise Profile Clean System 20 µm aperture 3 8 3 5 Noise Profile Co...

Page 12: ...xii List of Figures ...

Page 13: ... Window 3 33 4 1 SOM Wizard Step 1 Field Descriptions 4 3 4 2 File Name Generation Codes 4 5 4 3 Control Mode Step 2 Selections 4 7 4 4 Run Settings Step 3 Entries and Selections 4 8 4 5 Threshold Current and Gain Step 5 Entries or Selections 4 13 5 1 Printing Sample Information in Reports 5 3 5 2 Size Graphs Window Selections 5 4 5 3 Overlay Statisitcs Options 5 6 5 4 Interpolation Display Data 5...

Page 14: ...xiv List of Tables ...

Page 15: ...lar microprocessor running Beckman Coulter s Multisizer 4 software on Microsoft Windows operating system versions NT 4 0 2000 or XP 1 Figure 1 Multisizer 4 Analyzer How the Multisizer 4 Works The Multisizer 4 uses a unique mercury free isolated piston system to draw suspensions through the aperture at a steady rate and to meter these liquid volumes precisely enough to measure accurate particle con...

Page 16: ...k space Although in this form the raw pulse data is lost and cannot be re analyzed at a different resolution the processed results still can be enlarged or a region of interest selected using the Zoom facility in the software Both number data and size distributions are corrected by proprietary algorithms for the occurrence of multiple particle passage coincidence in the aperture An indicator provi...

Page 17: ...n be individually named for ease of archiving and retrieval Number and date formats are supported in both conventional as well as in ISO 9276 1 forms Multisizer 4 Components The Multisizer 4 system comprises an integrated fluid handling and pulse processing unit the Analyzer Module and a personal computer with a monitor with a minimum resolution of 1024 by 768 A keyboard mouse and an ink jet print...

Page 18: ...d particle density and the lower limit by the aperture size solution conductivity and environmental conditions Displayable size units µm µm2 µm3 fL Number of channels Pulse data is stored in unchannelized form and can displayed in up to 400 size classes for any selected size range The number of channels and their range can be reprocessed as necessary Digital pulse processor High speed digitalizati...

Page 19: ...0 4 16 0 4 12 12 16 0 034 2 14 103 0 034 905 905 2 14 103 30 0 6 24 0 6 18 18 24 0 113 7 24 103 0 113 3 05 103 3 05 103 7 24 103 50 1 0 40 1 0 30 30 40 0 524 33 5 103 0 524 14 1 103 14 1 103 33 5 103 70 1 4 56 1 4 42 42 56 1 44 92 0 103 1 44 38 8 103 38 8 103 92 0 103 100 2 0 80 2 0 60 60 80 4 19 268 103 4 19 113 103 113 103 268 103 140 2 8 112 2 8 84 84 112 11 5 736 103 11 5 310 103 310 103 736 1...

Page 20: ...ions Reactions can occur between incompatible solvents and electrolyte salts and may be violent Do not use azide and cyanide salts in acid solutions Flammable electrolyte solutions should be prepared for use in an appropriate environment and brought to the instrument only when required for an analysis Mechanical Warnings Do not interfere with or attempt to disable the interlocks incorporated in th...

Page 21: ...tage transformer or regulator Chemical Cautions If Beckman Coulter ISOTON II is used the Multisizer 4 must be drained and flushed through with distilled water before carrying out a sodium hypochlorite solution bleach disinfection procedure If the Multisizer 4 has been subjected to a bleach disinfection procedure the instrument must be drained and flushed through with distilled water before refilli...

Page 22: ...PN A51387AB xxii Introduction Before You Start Warnings and Cautions ...

Page 23: ...on Sample Platform Beaker and Accuvette Guides Beaker guides on the sample platform align Multisizer 4 Smart Technology Beakers and Accuvette STs relative to the aperture tube for optimal and repeatable results For more information on the Beaker and Accuvette guides see Sample Platform page 1 9 Automatic Stirrer Positioning Software controls automatically position the stirrer based on beaker and a...

Page 24: ...r for a 2000 µm aperture tube The standard range is 2 to 60 an extended dynamic range of 60 to 80 is available to examine broad distributions that extend above the 60 threshold This feature is intended for examining particles in the small tail of a distribution that extends above 60 For best results and to minimize blockage it is recommended to use a larger aperture size for samples that contain a...

Page 25: ...of noise in sample analyses see Reducing Noise page 9 1 NOTE The Multisizer 4 software will display an error message if you attempt to start a sample run while the door is open For information on components inside the Sample Compartment see Sample Compartment page 1 3 Control Panel The Control Panel is located in the center of the front panel Figure 1 1 B For information on Control Panel buttons s...

Page 26: ...ssary to calibrate the weight sensors only once when you set up the Analyzer If you switch to an electrolyte with significantly different density however you may need to recalibrate the Electrolyte and Waste Jar sensors see Calibrating the Electrolyte and Waste Jars page 9 13 Installing and Removing the Electrolyte and Waste Jars The lids of the Electrolyte and Waste Jars remain attached to the An...

Page 27: ...stirrer control buttons during sample runs use the Edit the SOM Standard Operating Method window in the Multisizer 4 software To disable the Control Panel stirrer buttons 1 In the Multisizer 4 software Main Menu select SOP Edit the SOM 2 In the Edit the SOM Standard Operating Method window select the Stirrer tab 3 On the Stirrer tab check the box next to Disable instrument keypad during run and cl...

Page 28: ...the door is open or the sample platform is not in place The amber Attention light duplicates the function of the amber LED light in the Sample Compartment When the amber light flashes the Multisizer 4 software displays an error message Stir ON Button The Stir ON button is located below the Analyzing and Attention lights on the Control Panel Figure 1 3 C The toggle button turns the stirrer on or of...

Page 29: ...er Figure 1 3 F to scan information about the following directly into the Multisizer 4 software Beckman Coulter ISOTON II labels Beckman Coulter Smart Technology Aperture Tubes size and serial number Sample Beckman Coulter Multisizer 4 Smart Technology Beakers To configure the bar code reader see Bar Code Reader Configuration Options page 8 15 To use the Bar Code Reader In the Multisizer 4 softwar...

Page 30: ...ng an aperture tube see Installingan ApertureTube page 3 2 Aperture Tube Knob The aperture tube knob Figure 1 4 B secures the aperture tube in place The knob is in the locked position when pointing up 12 o clock position To remove an aperture tube first unlock the aperture tube knob by turning the knob in either direction until it points down 6 o clock position A Aperture tube B Aperture tube knob...

Page 31: ...two usable sides One side of the platform has a guide for Multisizer 4 Smart Technology Beakers Figure 1 5 The other side of the platform has a built in guide for Accuvette STs Figure 1 6 The guides ensure that a beaker or Accuvette ST will be in the correct position relative to the aperture tube external electrode and stirrer when you raise the platform The guides ensure consistent results by mai...

Page 32: ...form only when it is located at or near the loading position This ensures that the platform does not bump the aperture tube or stirrer while rotating 2 Grasp the platform and lift the platform slightly It is not necessary to use the platform release 3 Pull the platform toward you You will feel the resistance of a spring mechanism 4 Continuing to hold the platform away from the rear of the sample c...

Page 33: ...ing the platform to the analysis run position External Electrode The external electrode is located in the upper left corner of the Sample Compartment just behind or to the side of the aperture tube Figure 1 4 E The external electrode creates an electrical current that passes through the aperture orifice As particles suspended in the electrolyte solution flow through the orifice during an analysis ...

Page 34: ...you clean the Particle Trap when particles have settled and filled one quarter of the Trap If you allow particles to collect above the one quarter mark large particles may recirculate and damage the system Status and Illumination Lights There are two LED status lights located at the right of the Sample Compartment next to the Particle Trap Figure 1 4 H The green Analyzing light is on when the Anal...

Page 35: ...e necessary to manually adjust the position of the beaker on the platform Variations in the position of the beaker relative to the aperture tube electrode and stirrer during analysis runs can produce inconsistent results Accuvette STs Beckman Coulter Accuvette STs are disposable and include a secure lid to prevent spills and contamination Rounded corners in the interior encourage re suspension of ...

Page 36: ...atform design see Sample Platform page 1 9 Are designed for convenience and to ensure consistent and accurate results For information on selecting the appropriate aperture tube size for your sample range see Selecting an Aperture Size page 3 1 Aperture tubes are fragile and require proper handling For information on small Aperture Tube handling cleaning and operating procedures see Using Small Ape...

Page 37: ... system components it is highly recommend that you wear powder free latex or nitrile gloves To clean the aperture tube and electrode 1 Press the platform release Figure 1 4 D towards the back of the Sample Compartment and lower the platform to the loading position 2 Use a squeeze bottle filled with clean or pre filtered ISOTON II to rinse the aperture tube external electrode and the stirrer Figure...

Page 38: ... select Run Drain System 2 Remove and empty the Electrolyte and Waste Jars 3 Replace the Waste Jar Clean the system with de ionized water 4 Rinse and fill the Electrolyte Jar with clean or pre filtered de ionized water 5 Replace the Electrolyte Jar 6 On the Multisizer 4 software Instrument Toolbar click Empty to empty the Waste Tank 7 On the Multisizer 4 Main Menu bar a Select Run Fill System or c...

Page 39: ...tton to flush the aperture tube 15 Flush the aperture tube three times Pre Filtering the Electrolyte and Cleaning Fluid When working with small apertures it is necessary to pre filter de ionized water and or ISOTON II used to fill flush or clean the system and accessories Filter the Isoton II or diluent solution with a compatible 0 2 µm filter A 0 1 µm filter can also be used in series with a 0 2 ...

Page 40: ...or each function you would like the Analyzer to perform on startup b Click Start NOTE The Multisizer 4 performs best when it has reached a steady working temperature This typically takes 15 minutes from powering on the Analyzer Preparing the Analyzer for Sample Runs To prepare the analyzer for a calibration control or sample analysis run 1 Start the Analyzer and connect the software to the Analyze...

Page 41: ...orm release and lower the platform to the loading position 6 If necessary turn the platform so that the correct side ST Beaker or Accuvette ST is on top see Sample Platform page 1 9 NOTE The sample platform has two usable sides The ST Beaker side has a built in guide to ensure that a Multisizer 4 Smart Technology Beaker of any size is in the correct position when you raise the platform The Accuvet...

Page 42: ...PN A51387AB 1 20 Analyzer Overview Preparing the Analyzer for Sample Runs ...

Page 43: ...ram from your program list 2 The Beckman Coulter Multisizer 4 startup window opens The window displays the software version the current date and time and your security configuration Connecting the Software to the Analyzer Connecting Analyzer and Software on Startup To connect the software to the Analyzer 1 In the Beckman Coulter Multisizer 4 dialog box select the Connect to Multisizer 4 checkbox ...

Page 44: ...r password it will be necessary to exit the system For more information see Logging In page 8 18 Connecting to the Analyzer Using the Software Main Menu To connect the software to the Analyzer select Run Connect to Multisizer 4 on the Main Menu bar Disconnecting from the Analyzer Using the Software Main Menu To disconnect the software from the Analyzer select Run Disconnect from Multisizer 4 on th...

Page 45: ...software in no security mode a Configuration drop down menu appears If you are running the Multisizer 4 software in security mode with Administrator or Supervisor privileges an Administrator or Supervisor drop down menu appears that includes configuration and other security related items Menu items in the Configuration Administrator or Supervisor drop down menu allow the user to remove items from ...

Page 46: ...e remove or load a Standard Operating Procedure Create edit or load a Standard Operating Method Create edit or load Preferences Review or print SOM information Review or print Preference information Run Start stop cancel pause resume reset preview repeat or start a 60 to 80 run Initiate system functions empty the Waste Tank fill the system unblock the aperture tube etc Turn the stirrer and lamp on...

Page 47: ...cond group duplicates features available in the File drop down menu and SOP Edit Preferences Graph Options window The third group duplicates features available in the Main Menu and Run Menu The fourth group duplicates features available in the Calibration drop down menu Windows Copy or save the current window as a bitmap Select view options for open files Minimize or restore all open files to the ...

Page 48: ...rlay Up Change the current folder for files to the folder one level above The current folder is displayed in the Status Bar in the bottom left corner of the Multisizer 4 software window Fonts Open the Fonts Colors tab of the Edit Preferences window This button allows you to change fonts for the file currently open in the Viewing Area and save these settings for future use Table 2 2 Main Toolbar Bu...

Page 49: ...able if you have opened multiple files for an average overlay or trend For more information see Moving Between Multiple Files Cursor Menu and Shortcut page 7 25 Legend Move the legend from corner to corner in the open analysis or remove the legend This button is only available when viewing a graph Table 2 2 Main Toolbar Buttons Second Group Click To Table 2 3 Main Toolbar Buttons Third Group Click...

Page 50: ...on during an analysis run Pulses Display electrical pulses as a graph or listing Zoom Display only the area of the graph between two cursors Before clicking the Zoom button first insert two cursors on a graph as follows a single click within the graph area creates a single cursor Click drag and un click to create two cursors one at the click point the other at the un click point After displaying a...

Page 51: ... Information if entered and SOM information if entered In the SOP pane click Load SOP to load a Standard Operating Procedure In the Sample Information pane click Edit Info to enter or update sample information In the SOM pane click Edit SOM to make changes to the Standard Operating Method Below the SOP Sample Information and SOM panes the Status Panel displays the status of the stirrer and fluid l...

Page 52: ...isplays a graph or listing showing the particle size distribution in progress You can work with multiple analysis files To change how the Viewing Area displays multiple files open the Windows drop down menu in the Main Menu bar and select one of the following options Cascade Tile Tile Horizontal Tile Vertical Minimize All Restore All Run Menu The Run Menu bar is located in the Viewing Area at the ...

Page 53: ...peat an analysis run with the same settings Pause Pause an analysis run Resume Resume an analysis run after pausing If you pause a 30 second timed analysis after 10 seconds the Resume button will run only the 20 second remainder of the analysis time If you pause a run and then press Continue the software will re run the 30 second analysis with your original settings and add the data to the data al...

Page 54: ... to unblock the aperture flush the system of particles or fill the system Status Bar The Status Bar is located in the lower left corner of the Multisizer 4 software window The Status Bar text displays the current path and folder if you are not mousing over a drop down menu item or a brief description of a highlighted menu item Table 2 6 Instrument Toolbar Function Buttons Click To Unblock Reverse ...

Page 55: ...rture Tube Wizard to install the new aperture tube Selecting an Aperture Size Select an aperture tube size based on the size of the particles you will be measuring The Analyzer can accurately measure particles between 2 and 80 of the aperture size and in the range of 10 to 80 of the aperture diameter for a 2000 µm aperture tube CAUTION If you select a 20 µm or 30 µm aperture Beckman Coulter recomm...

Page 56: ...tal Standard Extended Total Standard Extended 20 0 4 16 0 4 12 12 16 0 034 2 14 103 0 034 905 905 2 14 103 30 0 6 24 0 6 18 18 24 0 113 7 24 103 0 113 3 05 103 3 05 103 7 24 103 50 1 0 40 1 0 30 30 40 0 524 33 5 103 0 524 14 1 103 14 1 103 33 5 103 70 1 4 56 1 4 42 42 56 1 44 92 0 103 1 44 38 8 103 38 8 103 92 0 103 100 2 0 80 2 0 60 60 80 4 19 268 103 4 19 113 103 113 103 268 103 140 2 8 112 2 8 ...

Page 57: ...are highlights the aperture tube size serial number and Kd Click OK If the ST Aperture Tube has not been entered into the system the software displays the aperture tube size and serial number To enter this information use the Add New Aperture Tube window 6 Open the Sample Compartment door 7 Lower the platform to the loading position using the platform release see Platform Release page 1 11 8 Turn ...

Page 58: ...lyte Clean the system thoroughly prior to using a small aperture tube Clean ST Beakers Accuvette STs jars ST Aperture Tubes and other accessories Run a noise profile to verify a low background count Use appropriate current and gain settings Store the aperture tube properly Adhere to nano particle calibration standards if applicable Handling Small Aperture Tubes Always wear powder free latex or nit...

Page 59: ... accurate particle counts if the instrument is located in a dust laden atmosphere Minimize Analyzer exposure to dust debris and airborne contaminants Reduce acoustic noise levels Small apertures are extremely sensitive to ambient noise banging fan motors even loud voices Power off other machines and equipment in the vicinity if possible Reduce vibration Do not place the Analyzer on a table top tha...

Page 60: ...system components and accessories in pre filtered ISOTON II see Pre Filtering the Electrolyte and Cleaning Fluid page 3 5 System components and accessories include Electrolyte Jar Aperture Tube Electrode Particle Trap ST Beaker or Accuvette ST When handling small aperture tubes and other system components wear powder free latex or nitrile gloves To clean the aperture tube and electrode 1 Pressthep...

Page 61: ...hat can be used to supplement the beaker immersion cleaning method Figure 3 3 Cleaning an ST Aperture Tube with a Squeeze Bottle Small Aperture Noise Profiles The images below illustrate a typical noise profile obtained using a clean system and a noise profile obtained using a system that requires additional cleaning The noise profile obtained using a clean Analyzer system Figure 3 4 shows a backg...

Page 62: ...damaged or blocked NOTE Figure 3 4 is an example of a clean noise profile Factors such as aperture size current and gain settings and electrolyte can affect results The noise profile graphs below show the relative difference between a system that is performing well Figure 3 4 and one that may need cleaning Figure 3 5 For information on subtracting a blank run to obtain a noise profile see Using Bl...

Page 63: ...the Change Aperture Tube Wizard see Step 8 Set Current and Gain page 3 28 or the Edit the SOM window see Standard Operating Method Threshold Current and Gain page 4 13 Storing Small Aperture Tubes To store an aperture tube 1 Remove the aperture tube from the Sample Compartment 2 Rinse the tube inside and outside several times with pre filtered de ionized water see Cleaning System Components and Ac...

Page 64: ...alculated the mean to verify that the instrument is measuring calibrator bead size accurately Unlike the aperture calibration procedure which returns a calibration constant Kd for the aperture orifice the verification procedure returns the measured calibrator bead size NOTE Calibration options are only available to user types with sufficient security privileges If the Multisizer 4 software is runn...

Page 65: ...ith high levels of nano particle contamination will require several filling and draining cyclesto returnbackground counts to normal levels For informationontherecommended cleaning procedure see Cleaning the Analyzer page 1 16 Selecting Calibration Options To select calibration options 1 Select Calibration Aperture Calibration Options on the Main Menu bar The Aperture Calibration Options window ope...

Page 66: ...e Day s field enter the number of days between reminders c Click OK Preparing the Analyzer for Calibration To prepare the Analyzer for calibration 1 Fill a clean ST Beaker or Accuvette ST with electrolyte solution NOTE For aperture tubes up to 100 µm you can use an Accuvette ST 20 mL and pre filtered ISOTON II see Pre FilteringtheElectrolyteandCleaningFluid page 3 5 Use an STBeaker forany aperture...

Page 67: ...em If necessary dilute the sample to lower the concentration to an acceptable level If the concentration of calibrator beads is greater than 10 the Concentration index bar will display High If the concentration of particles is too low calibration time will increase In either case stop the calibration adjust the calibrator concentration and recalibrate the aperture CAUTION If you are using a polyst...

Page 68: ...y be difficult to clean a high concentration of calibrator beads from the system If necessary dilute the sample to lower the concentration to an acceptable level If the concentration of calibrator beads is greater than 10 the Concentration index bar will display High If the concentration of particles is too low calibration time will increase In either case stop the calibration adjust the calibrato...

Page 69: ...e Calibrate Aperture window the Kd pane displays the Old and New Kd values Table 3 3 Pausing Stopping Calibration Click To Pause Pause the calibration Stop Stop the calibration The Multisizer 4 software displays calibration results from the stopped run in the Calibrate Aperture window Cancel Cancel the calibration The Multisizer 4 software does not display calibration results To restart calibratio...

Page 70: ...OTE When you calibrate the aperture the Multisizer 4 runs an analysis to measure calibrator beads of a predetermined size ranging from a nominal modal value of 2 µm to 90 µm Deviations in the Analyzer s measurement of the calibrator beads determine the calibration constant Kd required for the Analyzer to measure the beads at their actual size The Kd takes into account many factors associated with ...

Page 71: ...ure page 3 16 you can manually enter the Kd value using the Change Aperture Tube Wizard To enter the mean Kd value 1 Select Run Change Aperture Tube Wizard on the Main Menu bar 2 In the Change Aperture Tube Wizard click Aperture Tube to the right of the Select a new aperture tube step The Select Aperture Tube window opens Table 3 4 Obtaining Mean Kd Value Run Kd 1 124 15 2 125 82 3 125 13 4 125 23...

Page 72: ...ick to highlight an Aperture Tube b Click OK to return to the Wizard 6 Click Close to exit the Wizard Verifying the Calibration When you verify aperture calibration the Multisizer uses the Kd or the mean Kd if you have obtained 10 Kd values and calculated the mean to verify that the instrument is measuring calibrator bead size accurately Unlike the aperture calibration procedure page 3 13 which re...

Page 73: ...e recommended calibrator size range is 10 to 20 of the aperture diameter however the software allows entries from 3 to 50 of the aperture diameter 3 Click Start 4 On the Status Panel verify that the Concentration index bar shows a value as close as possible to 10 NOTE Start with a low concentration and build up to 10 It may be difficult to clean a high concentration of calibrator beads from the sy...

Page 74: ...ide of the peak The cursor s define the mode or median used to calculate the new Kd If desired click Print to print the window This button does not display a dialog box or allow you to change print settings Table 3 5 Verifying Aperture Calibration If the window displays Then The Calibration is OK The measured particle size is within 3 of the actual calibrator size and the calibration was successfu...

Page 75: ...ibration file NOTE The Multisizer 4 software uses the m4 extension for all run data files including calibration runs 4 Click Save The Change Aperture Tube Wizard The Change Aperture Tube Wizard in the Multisizer 4 software provides step by step instructions to guide you through the steps you need to follow when installing a new aperture tube The Wizard allows you to verify aperture calibration tes...

Page 76: ... Aperture Tube Wizard Step 1 Select the new aperture tube page 3 23 Step 2 Remove the Currently Installed Aperture Tube page 3 26 Step 3 Install the New Aperture Tube page 3 26 Step 4 Place a Beaker of Clean Electrolyte on the Platform page 3 27 Step 5 Close the Door page 3 27 Step 6 Fill the System page 3 28 Step 7 Adjust the Metering Pump page 3 28 Step 8 Set Current and Gain page 3 28 Step 9 Me...

Page 77: ...ntified by size serial number and Kd has been entered into the software click to highlight the correct aperture tube To ensure that you select the correct aperture tube serial number and Kd you can scan the aperture tube bar code For information on using the Bar Code Reader see page 1 7 If the aperture tube does not appear in the list you will need to enter the aperture tube size serial number and...

Page 78: ...tube bar code in front of the Bar Code Reader The Multisizer 4 software will enter the aperture Diameter Serial Number and estimated Kd value in the appropriate text fields For information on using the Bar Code Reader see page 1 1 NOTE For information on aperture tube calibration see page 3 10 For information on obtaining the mean Kd see page 3 16 4 Click OK to return to the Select Aperture Tube w...

Page 79: ...ber Kd Comment box click the row you would like to edit b Enter a new Serial Number and or the mean Kd in the text fields see Obtaining the Mean Kd page 3 16 c Click Update 4 Click OK to return to the Select Aperture Tube window 5 In the Select Aperture Tube window a In the Diameter Serial Number Kd Comment box click to highlight the row displaying serial number and Kd of the aperture tube you ins...

Page 80: ...stalling an Aperture Tube page 3 2 In the Change Aperture Tube Wizard click Next to proceed to the next step Install the new aperture tube page 3 26 Step 3 Install the New Aperture Tube After you remove the previously installed aperture tube from the Sample Compartment the Change Aperture Tube Wizard prompts you to install the new aperture tube For instructions see Installing an Aperture Tube page...

Page 81: ...latform beaker side up The beaker guides ensure that a Multisizer 4 Smart Technology Beaker of any size will be in the correct position in relation to the aperture tube electrode and stirrer when you raise the platform If you are using an Accuvette ST reverse the platform to use the Accuvette ST guide see Sample Platform page 1 9 6 Raise the platform until it locks into position for an analysis ru...

Page 82: ...ys READY and the Wizard automatically highlights the next step Adjust the metering pump page 3 28 Step 7 Adjust the Metering Pump This step appears in the Change Aperture Tube Wizard only if you are using an aperture tube smaller than 400 µm The metering pump is required only when using volumetric mode Aperture tubes 400 µm and larger can be used only in time and count modes For information on con...

Page 83: ... if it is not already highlighted 2 To the right of the Set Current and Gain step click Current Gain The Current and Gain Settings window opens 3 In the Current and Gain Settings window click Auto Set If you are using 20 µm or 30 µm aperture tubes Auto Set is not available Use the system defaults by clicking the Defaults button a The window expands to display automatic settings for particles and c...

Page 84: ... window select Particles or Cells If you select Cells enter the Maximum Cell Volume CAUTION Selecting Particles when you are analyzing Cells can cause cell damage due to a higher current setting 5 To return to system default settings click Defaults 6 Click OK to return to the Change Aperture Tube Wizard 7 The Wizard automatically highlights the next step Measure noise level page 3 30 Step 9 Measur...

Page 85: ... 3 10 TheMultisizer4softwarewillautomaticallyverifythe calibration of the aperture tube using the serial number you entered in Step 1 Select thenew aperture tube page 3 23 If you have not calibrated the aperture tube exit the Wizard and calibrate the aperture page 3 10 To verify aperture tube calibration 1 In the Change Aperture Tube Wizard click Next until you reach the step Verify Calibration 2 ...

Page 86: ... define the mode or median used to calculate the new Kd If desired click Print to print the window This button does not display a dialog box or allow you to change print settings When you click Close to exit the Verify Aperture Calibration window the Change Aperture Tube Wizard closes Table 3 6 Verify Aperture Calibration Window If the window displays Then The calibration is OK The measured partic...

Page 87: ...n factors none Mode Volumetric 500 µL Flush before run Yes Number of runs 1 File save print or export Off Size bins 400 log diameter size bins from 8 µm to 12 µm Coincidence correction On Edit Off View Differential number size graph linear diameter X axis graph displays number per mL when run is complete Setting Control Sample Options To specify a control sample run and set recurring reminders 1 S...

Page 88: ... the Every field enter the number of hours or days between control sample runs c Click OK Running a Concentration Control Sample To run a concentration control sample 1 Fill a clean Accuvette ST with 20 mL electrolyte solution and 0 2 mL 200 µL calibrator 2 Place the Accuvette ST on the Analyzer platform and raise the platform For more information on preparing the Analyzer see Preparing the Analyz...

Page 89: ...oncentration control run 6 The Multisizer 4 software flushes the system and begins the run 7 When the run is complete a second Concentration Control window opens and displays results The window displays a message that the concentration is low or high if the Analyzer measurement deviates from the concentration control by 10 or more If this occurs contact Beckman Coulter Service For information on h...

Page 90: ...PN A51387AB 3 36 Installing and Calibrating an Aperture Tube Running a Concentration Control Sample ...

Page 91: ...sizer 4 software when needed You can also include the Preferences file in a Standard Operating Procedure SOP For more information on setting Preferences see Creating a Preferences File page 5 1 Standard Operating Procedure SOP A Standard Operating Procedure SOP combines one Preferences file and one Standard Operating Method SOM into an overall settings file for a particular type of analysis Within...

Page 92: ...nel or select SOP Remove the SOP on the Main Menu bar To use the Standard Operating Method SOM Wizard 1 If you have not connected to the Analyzer select Run Connect to Multisizer 4 on the Main Menu bar 2 Select SOP Create SOM Wizard on the Main Menu bar The SOM Standard Operating Method Wizard opens The SOM Wizard includes the following steps Standard Operating Method Description page 4 3 Standard...

Page 93: ...tor name if desired Information entered in this field is displayed when you select RunFile Get Info on the Run Menu bar SOM Description A description for the SOM Information entered in this field is displayed when you select RunFile Get Info on the Run Menu bar Sample Description A description of the sample if desired Information entered in this field is displayed when you select RunFile Get Info ...

Page 94: ...ar For more information see Entering Sample Information page 6 5 By selecting file name options when you create a Standard Operating Method SOM you can use information entered in the Enter Sample Info for Next Run text fields to create individual or sequential file names that will help you organize your data To automatically generate a file name for each analysis 1 Select SOP Create SOM Wizard on ...

Page 95: ...ultisizer 4 field NOTE File extensions do not affect file format You can open any Multisizer 4 analysis with Multisizer 2 or 3 software Features specific to the Multisizer 4 will not be available when opened in earlier software versions 6 Click OK to save your settings Using File Name Template Codes In the File Name Generation window page 4 4 each sample information field is preceded by a code tha...

Page 96: ...e Save As on the Run Menu bar 3 In the Save As dialog box enter a new file name or location if desired 4 In the middle of the window select Save as read only and click Save In the SOM Wizard click Next to proceed to the next step Standard Operating Method Control Mode Use Step 2 of the SOM Wizard page 4 2 or the Control Mode tab of the Edit the SOM window page 4 23 to enter settings that will dete...

Page 97: ...is displayed Use Volumetric mode to move a precise volume of sample through the orifice of the aperture tube with a metering pump NOTE Volumetric mode is not allowed on aperture sizes greater than 360 µm The largest standard aperture size allowed is 280 µm Total Count The specified number of particles or cells corrected for coincidence has passed through the aperture Enter a number from 50 to 500 ...

Page 98: ... or the Run Settings tab of the Edit the SOM window page 4 23 to specify pre run prompts determine the number of runs and enter post run settings including automatic file save export and print settings NOTE While Preferences allows you to specify how you will view and print analysis results Step 3 in the SOM Wizard allows you to specify whether files will automatically print or export to another f...

Page 99: ... analysis results Saving pulse data allows you to change range resolution and other parameters of the analysis without re running the sample NOTE Including pulse data increases the size of saved files Export Data Automatically export analysis results to an external file type based on Export settings in Preferences Print Report Automatically print analysis results in a report Statistics graph and p...

Page 100: ...ition the stirrer based on the beaker size you select in the SOM Beckman Coulter recommends that you use Multisizer 4 Smart Technology Beakers with automatic stirrer positioning to ensure consistency and accuracy of results To use the SOM Stirrer Settings window 1 In the Sample Beaker pane select Accuvette ST or the beaker size you will be using To enter the beaker size automatically hold the bar ...

Page 101: ...teger between 1 and 60 or select the speed from the drop down list To find the appropriate speed for your beaker size and electrolyte combination position the stirrer and adjust the stirrer speed using the Speed and buttons on the Analyzer Control Panel In the Edit SOM Stirrer Settings window see Editing SOM Settings page 4 23 the Speed field will automatically display the number corresponding to ...

Page 102: ... Stirrer tab select Other in the Sample Beaker pane and enter a non standard beaker size 4 In the Stirrer Position pane select Manual 5 In the Sample Compartment manually position the stirrer 6 If desired change stirrer speed and direction 7 In the Current Settings pane click Copy The current stirrer angle appears in the Manual field 8 Click Apply or Save SOM to save your settings The stirrer will...

Page 103: ...ting Method Threshold Current and Gain Use Step 5 of the SOM Wizard page 4 2 or the Current and Gain tab of the Edit the SOM window to enter the lower limit of a size distribution as well as the electrical pulse size current and amplification gain that the Analyzer will use as particles pass through the aperture ...

Page 104: ...d for sizes greater than 50 of aperture diameter NOTE This setting cannot be changed during or after an analysis Aperture Current The current that will pass through the aperture Click Defaults to set the current and gain automatically for the aperture size you are using If the aperture current entry is high or low a warning message is displayed as follows Low message is displayed for sizes less th...

Page 105: ...d Pulse to Size Settings Use Step 6 of the SOM Wizard page 4 2 or the Pulse to Size Settings tab of the Edit the SOM window page 4 23 to enter the number of bins channels bin spacing and other information that will determine the range and resolution of analysis results After running the analysis you can change these settings by selecting Calculate Convert Pulses to Size on the Run Menu bar The ape...

Page 106: ...g Diameter By a linear progression of particle volume Linear Volume By a geometric progression of particle volume size Log Volume 4 In the Options pane select one or both of the following options Pulse Edit Select this option if you have a narrow distribution and would like to ensure accurate analysis results by eliminating large pulses Particles that do not pass through the center of the aperture...

Page 107: ...k 2 Select Use Pre dilution Factor if you are diluting your sample for example if you are adding electrolyte to a dry sample before you add the sample to the electrolyte solution in the beaker Enter the ratio of electrolyte solution to sample the pre dilution factor If you select Use Pre dilution Factor the software will not allow you to enter a dilution factor The only possible combination is Pre...

Page 108: ... will not allow you to enter a pre dilution factor 6 In the SOM Wizard click Next to proceed to the next step Standard Operating Method Blockage Detection Use Step 8 of the SOM Wizard or the Blockage tab of the Edit the SOM window page 4 23 to enter blockage detection settings Based on your settings the Multisizer 4 will automatically unblock the aperture or stop the run when the system detects a ...

Page 109: ...Select Off to disable automatic blockage detection Select Automatic from reference run to set blockage detection based on previous run data To select the previous run click Select Reference Run and browse to select the file The reference run must use the same aperture tube size Select Automatic from start of run to set blockage detection based on current run data 2 In the Blockage Action pane sele...

Page 110: ...mbinations however the count rate can increase Aperture Resistance Unusually high electrical resistance can indicate blockage when particles trapped in the aperture act as an electrical insulator or air in the aperture when sample fluid level is too low Concentration A brief spike in particle concentration indicates aperture blockage If the concentration returns to normal it is possible that the b...

Page 111: ...centage of change that will trigger an unblock procedure To set default values in the selected fields click Default Change Flow Rate is only available when you are running volumetric mode 4 You can specify that a momentary blockage occurring for fewer than a preset number of seconds be ignored Enter the number of seconds in the Blocked for at least X seconds field 5 Click OK to accept the blockage...

Page 112: ...dard Operating Procedure SOP is loaded To remove an SOP click Remove SOP in the Status Panel or select SOP Remove the SOP on the Main Menu bar If you are using the SOM Wizard 1 Select SOP Create SOM Wizard on the Main Menu bar 2 In the SOM Wizard click Next until you reach Step 9 Summary of Settings 3 In the Summary of Settings window click Save 4 In the Save a Standard Operating Method SOM window...

Page 113: ... The Edit the SOM window displays tabs that duplicate Step 2 through Step 8 of the SOM Wizard page 4 2 The tabs include Control Mode Select control mode settings to determine when an analysis run will end The Multisizer 4 can end a run based on elapsed time total count modal count or the volume of sample that has passed through the aperture For more information on the Control Mode window as it app...

Page 114: ...n that will determine the range and resolution of analysis results After running the analysis you can change these settings by selecting Calculate Convert Pulses to Size on the Main Menu bar For more information on the Pulse to Size Settings window as it appears in the SOM Wizard see Standard Operating Method Pulse to Size Settings page 4 15 Concentration Enter information about sample volume dens...

Page 115: ... SOM Control Mode tab To set automatic file name generation settings page 4 4 use the Run Settings tab To view current SOM settings select SOP SOM Info on the Main Menu bar To manually set the stirrer position and copy the angle into the SOM use the Edit the SOM Stirrer tab Click Save SOM available on every tab to save the current SOM settings Loading an SOM If you saved different Standard Operati...

Page 116: ... different settings NOTE If you are running the Multisizer 4 software in security mode the option to create a Standard Operating Procedure will not be available to all user types To create a Standard Operating Procedure 1 Select SOP Create SOP Wizard on the Main Menu bar The SOP Standard Operating Procedure Wizard Description window opens NOTE If you are running the Multisizer 4 software in securi...

Page 117: ...u want to include and click Open The name of the selected SOM file appears in the Wizard 7 Click Next to proceed to the next window in the Wizard Select a Preference File 8 In the Select a Preference File window click Select 9 In the Load Preferences window navigate to the Preferences file you would like to include and click Open The name of the selected Preferences file appears in the Wizard 10 S...

Page 118: ...rocedure window navigate to the appropriate folder the Multisizer 4 default is the SOP folder and click Save 14 To print the SOP summary click Print 15 To close the SOP click Done Loading an SOP To load a saved SOP file 1 Select SOP Load an SOP on the Main Menu bar 2 In the Load a Standard Operating Procedure SOP window navigate to the appropriate folder 3 Select the desired SOP and click Open NOT...

Page 119: ...an save your changes from any tab within the window NOTE If you open an analysis file and change its appearance using options on the Run Menu bar the format of the printed report will not change To change the format of a printed report use the Create Preferences Wizard or the Edit Preferences window Samples of data file formats are included in a subfolder of the Multisizer 4 software called Demoda...

Page 120: ...Analyzer is not connected the Edit Preferences window is available by selecting Preferences Edit Preferences on the Main Menu bar Different drop down menus appear in the Main Menu bar when the software is not connected to the Analyzer The Edit Preferences window displays the following tabs Printed Report Statistics Averaging and Trend Export Page Setup Graph Options Fonts and Colors View Options T...

Page 121: ...ng information previously entered in the Enter Sample Info dialog box page 6 5 check the Sample Info box in the top left corner of the Printed Report window To choose less sample information To include less information select both Sample Info and Short at the top of the Printed Report window The table below shows the information that will print if you select Sample Info or both Sample Info and Sho...

Page 122: ...uding a Size Distribution Graph in Printed Reports To include a size distribution graph in the report 1 In the Size pane of the Print Report window page 5 2 select Graphs 2 Click Select to choose different options for viewing the size distribution The Size Graphs window opens Operator X Run number X Electrolyte X Dispersant X Aperture diameter X Aperture current X Size bins X X Total count X X Cou...

Page 123: ...laced when you saved the analysis 8 Select Y Dx Diff Graphs to normalize the height of each bin based on the bin s width This option is useful when the bins are not evenly spaced 9 Select Use Sample ID As Title to include a sample ID title in printed reports You can select a different analysis title in Preferences Page Setup window by selecting Include Custom Title 10 Click OK to save your changes...

Page 124: ...nted Report window page 5 2 select Averaged Statistics to include this information Including a Comparison to Sample Specifications in Printed Reports The Multisizer 4 software allows you to compare data files to previously entered sample specifications page 6 9 In the Size pane of the Preferences Printed Report window page 5 2 select Compare to Sample Specifications to include this information in ...

Page 125: ... sum of the bins Mean The mean of each distribution Median The median of each distribution D p q Results of a formula used to calculate particle size surface area weight or volume based on particle diameter Set the D p q formula on the Preferences Statistics tab page 5 15 Mode The mode of each distribution S D The statistical deviation Variance The variance of each distribution C V The co efficien...

Page 126: ...roup to display the value of the first bin in each group or select Sum Bins in Group to display the value of the sum of the bins in each group Select All Bins to display results from the full range of the analysis Select Between Cursors to display only results between your defined cursors For information on setting and moving cursors see page 7 3 Select From and enter specific points in the From a...

Page 127: ... on the statistic you select in the Interpolation Type pane Number Volume Surface Area You can select only one statistical interpolation point to correlate to particle size c Select Number Volume Surface Area and or mL to display selected statistics in columns d Select Under Over or if you selected Size to Differential 4 In the Interpolation Points pane a To add an interpolation point enter the ne...

Page 128: ...ursors in a graph 6 Click OK to return to the Create Preferences Wizard Including Size Trend Information in Printed Reports In the Size Trend pane of the Preferences Printed Report window page 5 2 select Graph Listing or both to include size trend information in printed reports For more information on creating a trend analysis from multiple files see page 7 22 To include a trend graph 1 In the Siz...

Page 129: ...rend Listing window select variables to display in columns To change the d0 values to custom percentages click Custom Points and enter new values in the Custom Trend Points window These values allow you to divide the particle distribution of each run by percentage of particle size above and below a certain diameter For example d10 divides the particle distribution by the diameter at which 10 of th...

Page 130: ...2 select Filtration Efficiency 2 Click Sizes to the right of Filtration Efficiency The Filtration Efficiency Sizes window opens 3 In the Filtration Efficiency Sizes window a In the New Size field enter a particle size for which you want to show filtration efficiency b Click Add c Repeat Step a and Step b for each particle size d Select Show filtration efficiency at each size to include filtration ...

Page 131: ... the Preferences Printed Report window page 5 2 select Listing 2 Click Select The Pulse Listing window opens 3 In the Pulse Listing window a In the Columns pane select the values you want to include in the listing b In the Pulses to List pane enter the Group Size Select All Pulses to display results from the full range of the analysis Select Between Cursors to display only results between your def...

Page 132: ... display blockage monitor data independently of blockage settings in the SOM To show blockage monitor data in a graph 1 In the Pulse Data pane of the Preferences Printed Report window page 5 2 select Graph 2 Click Select The Blockage Monitor Graph window opens 3 In the Blockage Monitor Graph window a Select how blockage monitor data will appear for Volumetric Runs and Non Volumetric Runs b Select ...

Page 133: ...the Report Printing Order pane To change the order of printed report data 1 In the Report Printing Order field click the row you want to move 2 Click First Last Move Up or Move Down to move the row to the desired position Preferences Statistics Use Step 2 of the Create Preferences Wizard Statistics or the Statistics tab of the Edit Preferences window to select the statistics you want to display on...

Page 134: ...serting cursors in a graph Results to Print Select the variables you want to display Your selections determine both printed statistics and the statistics that display when you select Calculate Statistics in the Analysis menu Statistics Type Select Arithmetic or Geometric NOTE Select Arithmetic if you selected a Linear X axis in the Preferences Printed Report window Select Geometric if you chose a ...

Page 135: ... Specifications window a In the Categorize by pane select Mean Median or Modal Size b In the Category Size Range column enter the upper limit for each category The software displays the upper limit you enter as the lower limit for the next category c In the Category Name column enter the name of each category d Click OK to return to the Preferences Statistics window page 5 2 Preferences Averaging ...

Page 136: ...total volume in each bin Select Cumulative or Cumulative to view the total number of particles mass surface area or volume below or above each bin edge respectively In the Limits pane select trend limit specifications Select other options as desired NOTE Select Use Blank Subtract to include blank runs previously saved with analysis data when the software averages the runs After the software has av...

Page 137: ...nces Wizard Export or the Export tab of the Edit Preferences window to select statistics you want to export to another file type such as a Microsoft Excel spreadsheet To proceed from Step 3 to Step 4 click Next To export statistics to another file type 1 Select the statistics you want to export 2 In the Data Format pane select the type of list formatting you want Exported list items can be separat...

Page 138: ... Generated Analysis File Names page 4 4 Preferences Page Setup Use Step 5 of the Create Preferences Wizard Page Setup or the Page Setup tab of the Edit Preferences window to select formatting options and page elements that will appear in the printed report To proceed from Step 4 to Step 5 click Next For information on how to open the Create Preferences Wizard and the Edit Preferences windows see C...

Page 139: ... To proceed from Step 5 to Step 6 click Next For information on how to open the Create Preferences Wizard and the Edit Preferences windows see Creating a Preferences File page 5 1 Preferences Fonts and Colors Use Step 7 of the Create Preferences Wizard Fonts and Colors or the Fonts Colors tab of the Edit Preferences window to change fonts text color and background color for headings graphs and sta...

Page 140: ...lick OK to save your settings To change text color on the screen and in printed reports 1 In the Window Colors pane select Graphs Graph Statistics Statistics Listings or Warning Text 2 To change text colors for the selection only for example Graphs a Click Default Colors to return to Multisizer 4 defaults b Click Text Color to open the Color window Select a color in the palette or define a custom ...

Page 141: ...Preferences Wizard Set View Options View Preferences Description Default View Select one option in each column to choose how the analysis run is first displayed when the run is complete You can select Interpolation view only if you select Size in the left column Measuring Select Particles or Cells to change the description that appears on graphs and listings This setting will not affect analysis s...

Page 142: ...d buttons below the text box to return to a previous step Volume Units Select the volume unit you want to use Specific Surface Area Units Select the surface area units you want to use Blank Subtract Select Allow negative results if you want to display the negative result when a bin in the blank run contains more particles than a bin in the sample run If you do not select this option the displayed ...

Page 143: ... settings to a individual files and load them into the software If you are using only one set of preferences you can configure the Multisizer 4 software to automatically save updates to your preferences to a default file when you exit the software To save your preferences using the Create Preferences Wizard 1 Select SOP Create Preferences Wizard on the Main Menu bar 2 In the Create Preferences Wiz...

Page 144: ...enu In security mode the Configure Preferences menu item appears in the Administrator or Supervisor drop down menu if the user has logged in as an administrator or supervisor respectively The Configuration menu is available to all users when running the software in no security mode 2 In the Configure Preferences window check the box to automatically save your preferences to the default prf file wh...

Page 145: ...zer 4 Smart Technology Beaker or Accuvette ST with clean electrolyte and sample on the platform 6 Raise the platform and make sure that the aperture is immersed in the electrolyte 7 Close the Sample Compartment door Selecting Analysis Settings Before running an analysis you can select settings for analyzing a sample and viewing analysis files using the SOM Wizard page 4 2 and the Create Preference...

Page 146: ...ve the SOP page 6 3 To load a saved SOM file 1 Select SOP Load an SOM on the Main Menu bar 2 In the Load a Standard Operating Method SOM window navigate to the appropriate folder select the desired SOM and click Open NOTE SOM files are identified by the extension som Loading Preference Settings If you saved different Preferences settings to one or more file s you can load a different Preferences f...

Page 147: ...d print Preferences currently in effect 1 Select SOP Preference Info on the Main Menu bar 2 In the Preference Information window use the scroll bar to see the complete list of preference settings 3 Click Close To copy and print Preference settings To print your preferences or copy them to the clipboard click Print in the Preference Information window The following table describes the print and cop...

Page 148: ...s list to the clipboard 1 Click Print 2 In the Print or Copy List Box Contents window select Copy all lines to clipboard 3 Click OK Copy a portion of the Preferences list to the clipboard 1 In the Preference Information box drag to highlight the text you want to copy 2 Click Print 3 In the Print or Copy List Box Contents window select the Copy selected lines to clipboard 4 Click OK Table 6 1 Copy ...

Page 149: ... Enter Sample Info for Next Run window to createsequentialfilenamesthatwillhelp youorganizeyourdataforcomparingandoverlayingfiles see Creating Automatically Generated Analysis File Names page 4 4 When you create a Standard Operating Method SOM you can choose to display the Enter Sample Info window automatically before each analysis run to prompt the operator to enter sample information For more in...

Page 150: ... fields can be used to automatically create part of the file name page 4 4 Operator The operator s name or initials If you are logged in the software populates this field automatically Bar Code Bar code information on the sample packet if available To enter the sample bar code hold the bar code in front of the Bar Code Reader on the Analyzer Control Panel To scan bar codes on sample packets it may...

Page 151: ...The option to edit sample information after a run is available only to user types with sufficient security privileges If the Multisizer 4 software is running with no security every operator can edit sample information To update or enter sample information after an analysis run 1 Open the analysis file for which you will be entering sample information 2 Select Edit Edit Sample Info on the Run Menu ...

Page 152: ... in the Create Sample Specifications window will not affect or be affected by selections you make in Preferences page 5 1 Statistics you select in the Preferences Wizard or Edit Preferences window control view and print settings only b Enter a title for the sample specifications if desired c Select one or more options to specify the sample specification value and enter a Lower Limit Upper Limit an...

Page 153: ...w opens NOTE If a user does not have sufficient security privileges to edit sample specifications an Edit Sample Specifications Read Only window opens 3 Enter information in the text fields and click OK to save your settings Including Sample Specifications in a Printed Report To include sample specifications in a printed report 1 Select SOP Edit Preferences on the Main Menu bar The Edit Preference...

Page 154: ...E If the user does not have sufficient security privileges to edit size data the Edit Size Data menu item will not appear in the Edit drop down menu 3 Enter information in the text fields and click Replace to change measured data 4 Click OK to save your settings Running an Analysis To run an analysis follow the steps below to prepare the Analyzer and Multisizer 4 software and run the analysis To r...

Page 155: ... intended for examining particles in the small tail of a distribution that extends above 60 NOTE A 60 to 80 run uses special SOM settings which override some parameters that the user may have set such as aperture current and sizing threshold To obtain results for larger particles using customized settings select a larger aperture tube NOTE Aperture blockage is common when sample diameters are larg...

Page 156: ... As on the Run Menu bar if you did not configure the Multisizer 4 software to automatically generate analysis file names To set automatic file name generation see page 4 4 5 After the analysis is complete select and install a smaller aperture tube 6 Sieve filter or use another suitable method to remove the particles from the suspension that will block the smaller aperture 7 Repeat Step 2 through S...

Page 157: ...articles Beckman Coulter recommends that you thicken the electrolyte to increase particle suspension reduce the flow rate and produce less noise Recommended thickening agents include glycerol and sucrose To determine particle concentration using time mode 1 Fill the beaker to approximately 9 10 of its capacity and measure the exact amount of electrolyte you will be using Place the beaker on the pl...

Page 158: ...ating Procedure page 4 28 or Standard Operating Method page 4 25 you will be using for the sample analysis NOTE If you set automatic file name generation page 4 4 change the file name to indicate that the run is blank either before or after the analysis run 2 Prepare the Analyzer page 1 18 3 Fill a beaker with clean electrolyte and place the beaker on the sample platform 4 Select Run Start on the ...

Page 159: ...ysis subtraction select Sample Remove Blank on the Main Menu bar Loading a Blank Run into an Open Analysis File To load a blank run for a single analysis 1 If the analysis is not open in the Viewing Area open a saved analysis page 7 17 2 Select Calculate Load Blank Run on the Run Menu bar 3 In the Load a Blank Run window navigate to the saved blank analysis and click Open The software automaticall...

Page 160: ...PN A51387AB 6 16 Analyzing a Sample Using Blank Runs ...

Page 161: ...n the Run Menu bar page 2 10 You can use items in this menu to select display and analysis settings Sample data files can be found in the Demodata file folder on the instrument controller Use these files to practice the file preference options described in this chapter The Run Menu bar changes based on the display and analysis options you select in the View drop down menu page 7 2 Changing Print S...

Page 162: ...hree menus will appear to the right of the View menu Graph Calculate and Display The Graph drop down menu and the options available in the Calculate drop down menu will differ based on the analysis type you select Size Pulses or Blockage Monitors Listings and Interpolation If you select View Listing or View Interpolation the drop down menu to the right of the View menu will change to Listing or In...

Page 163: ...iew statistics between two points Table 7 1 Using Cursors in Graphs If you want to Then Insert one cursor or the first cursor Click once in the graph to insert a cursor The placement of the cursor on the X axis appears in numerical form below the graph Insert a second cursor Left click on the first cursor and drag it to another position on the graph Un click to create a second cursor The first cur...

Page 164: ...itors Size Column Format If you select View Listing then select Size the Size Listing window opens when you select Listing Column Format To select the columns of data that will appear in the size listing 1 In the Columns pane a Select Bin Number to include the bin number next to each bin value b Select Lower Edge Upper Edge or Center to print the smallest largest or median particle size volume or ...

Page 165: ...es the Pulses Listing window opens when you select Listing Column Format To select the columns of data that will appear in the pulse listing 1 In the Pulse Listing window select the statistics in the Columns pane that you want to display 2 In the Pulse Grouping pane enter the Group Size in the field a Select All Pulses to display results from the full range of the analysis b Select Between Cursors...

Page 166: ...ll selections 3 Click OK Calculate Menu For information on available menu items in the Calculate drop down menu see Viewing Statistics page 7 8 Viewing Interpolations An interpolation allows you to divide a particle size distribution into any number of bins channels of any size Interpolation is similar to viewing results by statistical percentiles but offers greater flexibility The Interpolate men...

Page 167: ...nt to correlate to particle size b Select one or more of these options Number Volume and or Surface Area and select and or mL for each selected interpolation type If you are displaying statistics to Size you can only select one option c Select Under Over or if you selected Size to Differential d In the Interpolation Points pane To add an interpolation point enter the new point in the field and cli...

Page 168: ...terpolation Wrap Printer Listings on the Run Menu bar This setting will not change Printed Report options previously set in the Preferences window To change printed report settings see Preferences Printed Report page 5 2 Viewing Statistics The Calculate drop down menu on the Run Menu bar allows you to view statistics regardless of whether the analysis window displays a graph listing or interpolati...

Page 169: ...ght corner of the statistics box Comparing Statistics to Sample Specifications If you created sample specifications page 6 7 select Calculate Compare to Sample Specifications to see analysis results compared to your pre set parameters Comparing an Analysis to a Standard Run If you have run an analysis as a standard for comparison with other analysis runs you can use items on the Run Menu bar to co...

Page 170: ...fields enter the low and high limits for the range of particle diameter sizes you will be analyzing If you want to analyze the broadest possible distribution based on aperture size click the 2 to 60 button 10 to 60 button if using a 2000 µm aperture as shown below c In the Bin Spacing pane select how the Multisizer 4 will determine bin spacing By an incremental count of particle diameters Linear D...

Page 171: ...place two cursors to delimit analysis results For information on inserting cursors see Using Cursors in Graphs page 7 3 3 Select Calculate Convert Pulses between Cursors on the Run Menu bar The graph view changes to display only results between the two cursor points NOTE Convert Pulses between Cursors allows you to select a range of particle sizes for analysis based on cursor points You can also e...

Page 172: ...Main Menu bar The Print Reports window opens 2 In the Print Reports window a In the Folders box double click the appropriate folder name The folder contents appear in the Files box b In the Files box click to highlight the file s you want to print To highlight multiple analysis files hold the Ctrl key down while clicking each file name or click one file and drag the files you want to include in th...

Page 173: ...lysis Files Viewing Analysis Files 7 d Click OK A second Print Reports window opens 3 In the Print Reports window click Print For information on how to change printer settings or Preferences using the Print Report window see page 7 14 ...

Page 174: ...Viewing Analysis Files Printing a Report of an Open Analysis File To print a report for an analysis file that is open in the Viewing Area 1 Select RunFile Print Report on the Run Menu bar The Print Report window opens 2 In the Print Report window ...

Page 175: ...nge the page orientation to Landscape 11 8 5 The page icon displays the current paper orientation Portrait or 8 5 11 Include Custom Title Enter a title for the report Check this box only if you have not already included a title on the Preferences Page Setup window page 5 20 Include Page Number Include page numbering in the report Page numbers appear in the upper right corner of each page Checking ...

Page 176: ...ata based on Standard Operating Method settings or you can save sample data to a file when the analysis is complete Saving Analysis Data Automatically To automatically save analysis data select appropriate Run Settings in the current Standard Operating Method and enter sample information before the run To save analysis data automatically 1 Select SOP Edit the SOM on the Main Menu bar The Edit the ...

Page 177: ...he Edit the SOM Run Settings window click OK Saving Analysis Data Manually If you have not used Standard Operating Method settings to save analysis data automatically page 4 2 or if you want to save analysis data using a new name you can save the file after the analysis is complete To save analysis data manually when an analysis is open in the Viewing Area 1 Select RunFile Save or RunFile Save As ...

Page 178: ...rt Size Data window a Click the down arrow in the Files of Type text field to select the imported file type or select All Files b Navigate to the appropriate folder and select the file you want to import c Click Open An import file window displaying the path and name of the imported file opens 3 In the import window specify the type of size distribution to import 4 Click and drag to select the dat...

Page 179: ...opriate folder name The folder contents appear in the Files box b In the Files box click to highlight the file s you want to open for overlay To highlight multiple analysis files hold the Ctrl key down while clicking each file name or click one file and drag over the files to be included c Click Add The files appear in the Selected Files box d Click OK The sample analysis data appear on one graph ...

Page 180: ...t RunFile Save Overlay List on the Run Menu bar 2 In the Save a List of Overlaid Files window navigate to the appropriate folder and enter a file name in the File Name field 3 Click Save NOTE Overlay files are identified by the extension ovr Opening a Saved Overlay File To open a saved overlay file 1 Select File File Tools Open Overlay List on the Main Menu bar 2 In the Open Overlay List window na...

Page 181: ...he Ctrl key down while clicking each file name or click one file and drag over the files to be included c Click Add The files appear in the Selected Files box d Click OK Adding Data to an Average To include data from another file in an averaged file 1 Select RunFile Open and Add to Average on the Run Menu bar The Open window opens 2 In the Open window navigate to the file you want to add and click...

Page 182: ...ve NOTE Average files saved as a list are identified by the extension avg Opening a Saved List of Averaged Files To open a self contained average file extension av 1 Select File Open on the Main Menu bar or click Open in the Main Toolbar 2 In the Open window navigate to the appropriate folder and select the file name 3 Click Open To open an average file saved as a list extension avg 1 Select File ...

Page 183: ...file s you want to include in the size trend analysis To highlight multiple analysis files hold the Ctrl key down while clicking each file name or click one file and drag over the files to be included c Click Add The files appear in the Selected Files box d Click OK Adding a File to a Size Trend To include data from another file to an open size trend analysis 1 Select RunFile Open and Add to Trend...

Page 184: ...the middle of the window 3 Click Save NOTE Size trend files are identified by the extension tr Opening a Size Trend To open a size trend file 1 Select File Open on the Main Menu bar or click Open in the Main Menu Toolbar 2 In the Open window navigate to the appropriate folder and select the file name 3 Click Open Merging Runs Merging runs allows you to view combined pulse data and size distributio...

Page 185: ...folder and enter a file name in the File Name field If you want to write protect the trend file select Save as read only in the middle of the window 3 Click Save NOTE Merged files are saved as analysis files and are identified by the extension m3 or m4 Moving Between Multiple Files Cursor Menu and Shortcut There are two ways to move between overlay files page 7 19 when a graph of the overlay is op...

Page 186: ...to highlight the two files you want to compare To highlight both analysis files hold the Ctrl key down while clicking each file name Include the analyses in the order in which they were run pre filtration and post filtration c Click Add The files appear in the Selected Files box d Click OK Saving a Filtration Efficiency Analysis To save a filtration efficiency analysis 1 Select RunFile Save or Run...

Page 187: ...menu you can use the Status Panel Settings or Toolbars items to customize the Status Panel the Main Toolbar and the Instrument Toolbar see Customizing the Status Panel page 8 8 and Customizing Toolbars page 8 7 Security Modes and Configuration If you are running one of four security modes page 8 16 configuration options are available only if the user logs in as an Administrator or Supervisor Menu ...

Page 188: ...re available to all users Main Menu Medium security Operator Mode Username and password required Configuration options are available to Administrator and Supervisor accounts only Main Menu Low security Operator Mode Login required for Administrator and Supervisor accounts only Configuration options are available to Administrator and Supervisor accounts only ...

Page 189: ...alibration Sample SOP Run and Configuration drop down menus on the Main Menu bar When you remove a menu item the corresponding shortcut button if one exists remains on the Main Toolbar For information on removing Main Toolbar buttons see Customizing Toolbars page 8 7 NOTE When you hide a menu item the Multisizer 4 software removes the item until you reinstate it using the Customize Main Menus wind...

Page 190: ...tems in the center pane are located on the Calibration drop down menu Calibrate Aperture Verify Aperture Calibration Run Concentration Control Aperture Calibration Options and Control Sample Options Create Sample Specifications is located on the Sample drop down menu Change Aperture Tube is located on the Run drop down menu Create Preferences is located on the SOP drop down menu Toolbars is locate...

Page 191: ...item the corresponding shortcut button if one exists remains on the Main Toolbar For information on removing Main Toolbar buttons see Customizing Toolbars page 8 7 To hide drop down menu items 1 Select Configuration Customize Run Menus on the Main Menu bar If you are running security mode select Customize Run Menus in the Administrator or Supervisor drop down menu 2 In the Customize Run Menus wind...

Page 192: ... in the View menu These dynamically generated menus allow you to change view options for each type of analysis display For more information on these menus see Viewing Analysis Files page 7 2 6 Select Display Menu to hide the Display drop down menu that appears when you select Graph in the View menu This dynamically generated menu appears only when you are viewing an analysis as a graph For more in...

Page 193: ...mizing Run Menus page 8 5 To customize the toolbars 1 Select Windows Toolbars on the Main Menu bar The Toolbars window opens 2 In the Toolbars window To remove the Main Toolbar clear the Show Main Toolbar checkbox To display the buttons without three dimensional edges select Flat Buttons To display buttons with text below the button image select Buttons with Text To display buttons with images onl...

Page 194: ...oolbar Buttons box and click Move Up or Move Down Click Close to save your settings and return to the Toolbars window 4 In the Toolbars window click OK when you are finished Changes take effect immediately You do not need to restart the Multisizer 4 software Customizing the Status Panel You can customize the colors that appear on the Status Panel adjust warning levels set the speed and volume of a...

Page 195: ...ulter recommends that you enter a value that is twice the Warning Level percentage The default Full Scale percentage is 20 d Click Color to change the scale color used to indicate that the concentration or coincidence correction level is within the acceptable range 3 In the Jar and Tank Bars pane a In the Warning Level box enter the percent full that will trigger a warning that is change the Jar o...

Page 196: ...ames 1 In the Main Menu bar select Configuration Customize Sample Info Names The Customize Sample Info Names window opens If you are running security mode select Customize Sample Info Names in the Administrator or Supervisor drop down menu 2 In the Customize Sample Info Names window a For each field name you want to change select it and enter a new name in the corresponding text field b Click OK C...

Page 197: ...security mode select Recent Files and Folders in the Administrator or Supervisor drop down menu 2 Folder List pane options In the on main menu field enter the number of recently used folders you want to make available from the File drop down menu If you enter 0 no recently used folders will appear on the menu In the on sub menu field enter the number of recently used folders you want to appear whe...

Page 198: ...d and or when the operator adds a file to an overlay page 7 19 6 In the Maximum name size field enter the maximum number of characters that will display in the File drop down list or the File submenus NOTE The number of characters you select for display in the Maximum name size field will not affect the maximum file name length you selected in the Standard Operating Method page 4 2 Selecting a New...

Page 199: ...oosing a Language You can choose the language that will appear in menus windows and printed reports To choose a language 1 Select Configuration Language on the Main Menu bar The Language window opens If you are running security mode select Language in the Administrator or Supervisor drop down menu NOTE Select the Kanji Character Set if your system cannot display special characters such as the Gree...

Page 200: ...elect new Help files User Manual Appendix and Bibliography as updates become available If the Multisizer 4 software cannot find Preferences Standard Operating Method and other settings files on startup one or more error messages will appear If one of these error messages appears use the Multisizer 4 Configuration window to reset default folder s for settings preferences and run files To change def...

Page 201: ... s Manual to select the location of the Multisizer 4 User Manual 5 Select Enable Dialog Help to display a shortcut to context sensitive online Help topics in Multisizer 4 software windows Help topics are not available from all windows 6 Click OK to save your settings Bar Code Reader Configuration Options You can use the Bar Code Reader on the Analyzer Control Panel to scan Beckman Coulter ISOTON I...

Page 202: ...dow select Use the Bar Code Reader 3 Select a port from the Port drop down list Because the software maps USB to COM ports the correct port may be difficult to determine If necessary select COM ports sequentially until you locate the correct port 4 In the Symbologies pane select Aztec and Data Matrix Select additional UPC symbologies only if you will be using the Bar Code Reader to scan sample pac...

Page 203: ...1 CFR Part 11 security click Add a User The Add a User Account window opens 4 In the Add a User Account window in the Full Name Log in Name and ID fields enter user information 5 In the Password field enter a password between 4 and 16 characters in length 6 Select Administrator from the Type drop down list The Administrator assigns privileges to each user type Reviewer Operator Operator using adva...

Page 204: ...n the Log in Mode pane select a user account type You can select the user type the Administratorassigned toyou forexample Operatorusingadvancedfeatures oranyusertype with lesser privileges 3 Click OK Logging Out If you are logged in as a Reviewer Operator or Operator using advanced features select Security Log Out from the Main Menu If you are logged in as a Supervisor select Supervisor Log Out on...

Page 205: ...are the Main Menu bar displays the Administrator drop down menu The Administrator drop down menu allows you to Configure security requirements and privileges for each user type page 8 20 Add user accounts page 8 16 Create electronic signature requirements page 10 5 View audit trails and error logs page 10 3 Configure the software interface page 8 1 Change your password and log out ...

Page 206: ...Privileges on the Main Menu bar The User Privileges window opens 3 In the Set default user privileges pane select a security level and click Set The software returns the security requirement and privileges to the default configuration for the security level you select 4 Select the security requirements and privileges for Reviewer Operator Operator using advanced features Supervisor and Administrat...

Page 207: ... noise Reduce the current or increase the conductivity of the electrolyte solution CAUTION Current set too high can saturate the amplifier damage the aperture orifice distort your results or damage cells Atmospheric interference A dust laden environment platform vibration or a loud environment can increase noise levels Electrical interference Any form of electrical interference can cause random no...

Page 208: ...reshold information either Threshold is too low or Threshold is OK If the threshold is set too low increase the threshold in the Create SOM Wizard page 4 2 or the Edit the SOM window page 4 23 If noise levels remain high or variable after troubleshooting contact Beckman Coulter Field Service page 9 15 Purging the Metering Pump Purging the metering pump removes air from a small chamber in the pump ...

Page 209: ...er When the Waste Tank vacuum is malfunctioning the Multisizer 4 software may display the following error message Check the Vacuum Regulator If this error message appears select Run Troubleshooting Check Vacuum Regulator The Status Panel displays progress If resetting the vacuum regulator does not resolve the problem contact Beckman Coulter Field Service page 9 15 Measuring Gain Stage Offsets The ...

Page 210: ...perture Resistance Settings on the Main Menu bar The Aperture Resistance Settings window opens 3 In the Gain Stage Offsets pane enter new values in the fields provided 4 If you are not running Service Mode a Read only button appears If you are running Service Mode click OK to save your settings System Error Unable to Measure Gain Stage Offsets If the Analyzer is unable to measure gain stage offset...

Page 211: ...tartup use the Multisizer 4 Configuration window to reset default folder s for settings preferences and run files To change default file locations Select Configuration Multisizer 4 Configuration on the Main Menu bar The Multisizer 4 Configuration window opens If you are running security mode select Multisizer 4 Configuration in the Administrator or Supervisor drop down menu For more information on...

Page 212: ...For information on setting automatic intervals for emptying the Waste Tank in the SOM see Standard Operating Method Control Mode page 4 6 To change default Waste Tank settings 1 Select Run Troubleshooting Waste Tank on the Main Menu bar The Waste Tank window opens 2 In the Waste Tank window To empty the Waste Tank after a specified number of completed runs select every X runs and enter the number ...

Page 213: ...s the default vacuum is set to six inches of mercury 6 00 Hg for most aperture sizes If you are using time or count control mode and an aperture tube larger than 560 µm you may need to change the Waste Tank vacuum setting CAUTION It is not possible to change vacuum or Metering Pump flow settings unless you are running Service Mode Beckman Coulter does not recommend that you use the options availab...

Page 214: ...is not possible to apply new settings unless you are running Service Mode page 9 15 Flow Rate Error Messages The default flow settings adjust for aperture tube size and are appropriate for most analyses Under certain conditions if you are using an unusually viscous electrolyte solution for example or if you have increased the vacuum for a large aperture tube it may be necessary to adjust the flow ...

Page 215: ...essages The default flow settings adjust for aperture tube size and are appropriate for most analyses Under certain conditions if you are using an unusually viscous electrolyte solution for example or if you have increased the vacuum for a large aperture tube it may be necessary to adjust the flow rate to avoid unnecessary error messages Fill Flush and Drain Settings Viewing System Flush Time You ...

Page 216: ...e and Technical Support page 9 15 To adjust system flush time 1 Select Run Troubleshooting Enter Service Mode on the Main Menu bar NOTE Entering Service Mode will allow you to change default settings in the Troubleshooting menu If you do not enter Service Mode settings in the Troubleshooting menu will appear as read only values 2 Select Run Troubleshooting Fill Flush and Drain Settings on the Main...

Page 217: ...Flush and Drain Settings on the Main Menu bar The Fill Flush and Drain Settings window opens and displays system Fill Time Flush Time and Drain Time in seconds CAUTION It is not possible to change the system drain time setting unless you are running Service Mode Beckman Coulter does not recommend that you use the options available in Service Mode without the assistance of a trained Service Represe...

Page 218: ...unning Service Mode Beckman Coulter does not recommend that you use the options available in Service Mode without the assistance of a trained Service Representative see Requesting Service and Technical Support page 9 15 To view aperture resistance settings 1 Select Run Troubleshooting Aperture Resistance Settings on the Main Menu bar The Aperture Resistance Settings window opens 2 If Enable Apertu...

Page 219: ...is not possible to change aperture resistance settings unless you are running Service Mode page 9 18 To change aperture resistance settings 1 Select Run Troubleshooting Enter Service Mode on the Main Menu bar NOTE Entering Service Mode will allow you to change default settings in the Troubleshooting menu If you do not enter Service Mode settings in the Troubleshooting menu will appear as read only...

Page 220: ...pty Electrolyte Jar in the Analyzer compartment see Installing and Removing the Electrolyte and Waste Jars 3 In the Calibrate Electrolyte Jar and Waste Jar window select Electrolyte Jar is Empty 4 In the Electrolyte Jar pane click Calibrate When calibration is complete Calibrated appears on the Electrolyte Jar is Empty line 5 Remove the Electrolyte Jar fill the jar and replace the jar in the Analy...

Page 221: ...port To contact a Service Representative 1 Select Help Contact Beckman Coulter on the Main Menu bar 2 In the Contact Beckman Coulter window Click Service Support to request help with instrument related problems Click Applications Support to request help with problems related to the Multisizer 4 software Click General Support for all other questions Each button opens your default email editor and i...

Page 222: ...g To locate the current version number 1 Select Help About on the Main Menu bar 2 In the Beckman Coulter Multisizer 4 window locate and record the software version number at the top of the window and click OK Updating Firmware and FPGA Software While the Multisizer 4 software runs on a PC connected to the instrument firmware is the programming and software that runs within the Analyzer If your fir...

Page 223: ...ting Instrument Schematic on the Main Menu bar The Instrument Schematic window opens In the Instrument Schematic window you can Select Pump to turn the vacuum pump on If you clear this section Vacuum Pump Off appears in the Status Bar Select Stirrer to turn on the stirrer You can also turn the stirrer off or on by selecting Run Stirrer Off or Run Stirrer On on the Main Menu bar Select Lamp to turn...

Page 224: ...error message manually print error messages or copy messages to the clipboard 3 When you are finished click Close Opening Service Mode When you select Troubleshooting Open Service Mode on the Main Menu bar a new Service menu appears in the Main Menu bar The Service menu includes advanced options for configuring and troubleshooting the Multisizer 4 software and Analyzer CAUTION Beckman Coulter does...

Page 225: ...realize that implementation and compliance of the rule remains the responsibility of the organization or entity creating and signing the electronic records in question Proper procedures and practices such as GLP and cGMP are as much part of overall compliance with these regulations as are the features of the Multisizer 4 control software Electronic Records Electronic record refers to any combinati...

Page 226: ...d to ensure proper operation maintenance and administration for system security and data integrity Persons who interact with the system from administrators to users must abide by these procedures Therefore the ultimate responsibility is with the organization generating electronic records and signatures The Multisizer 4 software is a component albeit a vital one of the overall process The controls ...

Page 227: ... the Multisizer 4 software After auditing has been enabled for a file it cannot be disabled nor can it be bypassed Under these conditions all changes made to a file are automatically recorded These changes consist of computer generated time stamped audit trails to independently record the data and time of operator entries and actions that create modify or delete electronic records When a change to...

Page 228: ...ftware generates an error log that stores and records errors associated with the system for example missing files and bad communications To select audit trail settings 1 Select File Open on the Main Menu bar The Audit Trail Settings window opens 2 In the Audit Trail Settings window select Enable audit trail 3 In the Select events to monitor pane select the required options 4 Click Browse to select...

Page 229: ...e individual s physical feature s or repeatable action s where those features and or actions are both unique to that individual and measurable Subpart A Section 11 3 These methods generally require fingerprints or retinal scans and require special scanning devices to read and interpret them Generating Electronic Signatures The Multisizer 4 software employs User IDs and passwords to verify the iden...

Page 230: ...signatures are administered and executed to ensure that attempted use of an individual s electronic signature by anyone other than the genuine owner requires collaboration of two or more individuals Through the application of Multisizer 4 user and password configuration procedures the system can be configured to ensure that use of these identifiers by someone other than the owner can be performed ...

Page 231: ...e which can be accessed only in administrator mode allows the administrator to securely store files in a separate location and in addition to locations specified by a user File Attributes This feature allows administrators to protect files in varying degrees using the file attribute options Starting the Multisizer 4 with Security Enabled After the Administrator has configured security settings the...

Page 232: ...PN A51387AB 10 8 Regulatory Compliance Additional Security Features ...

Page 233: ...necting software to using Main Menu 2 2 disconnecting from using the Main Menu 2 2 identifying 9 15 preparing for calibration 3 12 preparing for sample runs 1 18 starting 1 18 start up dialog 1 18 version number 9 16 Analyzing and Attention lights 1 6 Aperture calibrating 3 10 3 13 choosing calibrator size 3 10 Aperture calibration See Calibration Aperture current 4 14 Aperture resistance settings...

Page 234: ...izard 3 21 Comparison data including in reports 5 6 Concentration control sample running settings 3 33 specifying options 3 33 Configuration Menu 2 4 Configuration options 8 1 8 14 Context senstive help See Help 8 15 Control Panel 1 3 1 5 buttons 1 5 Control sample See Concentration control sample Create Preferences Wizard 5 1 Averaging and Trend 5 17 Export 5 19 Fonts and Colors 5 21 Graph Option...

Page 235: ...sing 8 13 Listing including in reports 5 7 Listing menu 7 4 Listings viewing 7 4 Logging in 8 18 Logging out 8 18 M Main Menu bar 2 3 drop down menus 2 4 Main menus customizing 8 3 Main Toolbar buttons 2 5 first group 2 6 fourth group 2 8 second group 2 6 third group 2 7 default configuration 2 5 Mean Kd obtaining 3 16 updating 3 17 Merged run saving 7 25 Metering pump adjusting 3 28 9 3 purging 9...

Page 236: ...s 5 12 Pulses to size converting 7 9 converting between cursors 7 11 converting for widest distributions 7 11 R Recent files list customizing 8 11 Recent Folders list customizing 8 11 Regulatory compliance 10 1 additional security features 10 7 audit trail 10 3 electronic controls 10 2 electronic records 10 1 electronic signatures applying 10 6 generating 10 5 10 6 maintaining 10 5 file history 10...

Page 237: ... 5 Smart Technology Aperture Tubes 1 14 Software configuration 8 1 Software startup resolving errors 9 5 SOM Standard Operating Method Wizard See SOM Wizard SOM Wizard 4 2 Blockage 4 18 Concentration Information 4 17 Control mode 4 6 Description 4 3 Pulse to Size 4 15 Size bins range 4 16 Run settings 4 8 Stirrer settings 4 10 Summary of Settings 4 21 Threshold Current and Gain 4 13 SOP Standard O...

Page 238: ...re resistance settings 9 13 changing waste tank settings 9 6 draining the system 9 11 flow rate errors 9 8 identifying the Analyzer 9 15 measuring gain stage offsets 9 3 measuring noise level 9 2 opening Service mode 9 18 opening the error log 9 18 purging the metering pump 9 2 reducing noise 9 1 resolving software startup errors 9 5 setting the vacuum regulator 9 3 updating Multisizer 4 software ...

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