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Rion KL-04 Instruction Manual

Light obscuration particle counter
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INSTRUCTION MANUAL
LIGHT OBSCURATION
PARTICLE COUNTER
KL-04
3-20-41 Higashimotomachi, Kokubunji, Tokyo 185-8533, Japan
http://www.rion.co.jp/english/

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Summary of Contents for Rion KL-04

  • Page 1 INSTRUCTION MANUAL LIGHT OBSCURATION PARTICLE COUNTER KL-04 3-20-41 Higashimotomachi, Kokubunji, Tokyo 185-8533, Japan http://www.rion.co.jp/english/...
  • Page 3 This manual describes the features and operation principles of the Light Obscuration Particle Counter KL-04. For information regarding the operation of other equipment in the case of incor- porating the KL-04 into a measurement system with other equipment, always make sure to refer to the documentation of the other equipment.
  • Page 4 Export the measured data Describes how to export the measured data by using the built-in fl oppy disk drive. Back Up Describes how to back up / restore measurement data by using the built-in tape drive. System Setting Provides a basic explanation of how to set the clock and how to connect with a net- work.

  • Page 5: For Safety

    FOR SAFETY In this manual, important safety instructions are specially marked as shown below. To prevent the risk of death or injury to persons and severe damage to the unit or peripheral equipment, make sure that all instructions are fully understood and observed. WARNING Disregarding instructions printed here incurs the risk of death or se-...
  • Page 7 Caution Types of sample fl uids The unit is designed for measuring liquid-borne particles. Never use the unit with the liquid types listed below, to prevent false measurement and the possibility of accidents and damage to the unit. Explosive liquid or mixtures containing explosive fl uid Hydrofl uoric acid or other fl uid which can cause corrosion of parts in contact with the fl uid or mixtures containing such fl uid Liquid with a temperature of less than +15°C or more than +30°C...
  • Page 8 WARNING Sample fl uid danger prevention When toxic sample fl uid comes into contact with any part of the human body or when toxic gases generated by the sample fl uid are breathed, there is a danger of severe injury or death.
  • Page 9 WARNING The unit uses a laser source This unit is designated as a class 1 laser product according to IEC 60825-1(2001). The internal particle detector mechanism uses a laser, but it is fully shielded so that the beam cannot exit from the enclosure. The identifi cation label shown at right is affi xed to the rear of the unit.
  • Page 10 viii...
  • Page 11 Precautions Operate the unit only as described in this manual. Use the unit in locations within the prescribed temperatures and humidity ranges (+15°C to +30°C, 20% to 80% RH). Store the unit in locations within the prescribed temperatures and humidity ranges (-10ºC to +50°C, 90% RH and less).

  • Page 13: Table Of Contents

    Changing the Window Size ..............29 Selecting Window ................. 29 Closing Windows .................. 30 Start Up ..................... 32 Power ON ..................... 32 Login ....................34 Workspace Menu .................. 35 KL-04 - Start New Window ..............36 Change Displayed Language ..............38...
  • Page 14 Operator ....................40 Operator Registration ................40 Add Operator ..................42 Change of Operator Registration Details ..........43 KL-04 - Operator Management Window ..........44 Measurements .................... 47 Basic Operations .................. 47 Measuring Sequence ................48 The Measurement Result ..............50 To Display Previously Measured Data ..........
  • Page 15 The Standardization of Units by the Regional Pharmacopeia ..... 140 Transport .................... 140 Troubleshooting ..................141 When the Letters / Figures on the KL-04 Controller Window appear in Red ..................141 When the Letters / Figures are Displayed in Orange on the KL-04 Controller ..............141 When the Performance-Test Fails ............141...

  • Page 17: Outline

    Outline The Light Obscuration Particle Counter KL-04 detects particles suspended in a fl uid and measures their size and numbers using the light-obscuration method. The unit is an automatic particle measurement system specially designed for process step control and quality management for example at medical production. The light-obscura-...

  • Page 18: Relationship Between Calibration, Performance-Test And Measurement

    * The basic measurement means that the unit is calibrated based on the method decided by RION Co., Ltd. Calibration and Performance-Test for JP, USP and EP will be registered only to the customers who has requested this option.
  • Page 19 In other words, if the Performance-Test data KL-04_Basic is selected, the Calibration data KL-04_Basic is applied to the unit and the unit is in the calibrated condition based on the method decided by RION Co., Ltd. Important The Performance-Test data complying with the purpose of the quality control test must be selected.
  • Page 20 Outline Procedure from preparation to measurement The fl ow chart below shows the general procedure from preparation to measurement. Detailed information on each procedure is described in the page number referenced in the chart. Preparation (Refer to page 9) Start Up (Refer to page 32) When the unit is started for the first time after being...

  • Page 21: Light Source

    Outline Light Source The life expectancy of a laser diode such as used in the KL-04 is shorter than that of other semiconductor devices. When the laser diode nears the end of its service life, the optical power falls below the rated level.

  • Page 22: Controls And Features

    Controls and Features Front Panel START button FLUSH button Liquid crystal display INLET Locking screw 1 Floppy disk drive Tape drive Sample stand Locking screw 2 START button Press the button to start the measurement. FLUSH button Press the button to start cleaning. Liquid crystal display Shows operation screen.

  • Page 23: Left Side Panel

    Controls and Features Left Side Panel Valve Tube guide Syringe cover Syringe Handle Syringe cover Clear plastic cover protecting the syringe. The unit will not operate when the cover is open. Tube guide Fixes the drain tube to protect it from being crushed. Valve The INLET opens when drawing in sample fl uid and the OUTLET opens when dis- charging it during draining.

  • Page 24: Rear Panel

    Controls and Features Rear Panel POWER switch POWER connector PRINTER connector KEYBOARD connector LCD switch MOUSE connector DISPLAY connector ETHERNET connector POWER switch Turns the power supply ON or OFF. POWER connector Connects to the unit’s power supply. PRINTER connector Connects to a printer.

  • Page 25: Preparation

    Preparation Installing the Sample Container Plate Push the sample container plate into the sample stand to secure as per the diagram be- low. Sample container plate Sample stand...

  • Page 26: Connecting Sampling Tube

    Preparation Connecting Sampling Tube The PFA sampling tube set provided contains a sampling tube (2×4 dia. length 100 mm) and nut. They need to be connected according to the following procedure. 1. Remove the end plug from the INLET connector by turning the end plug counter- clockwise.
  • Page 27 Preparation 3. Slide the tip of the sampling tube onto the INLET connector and turn the nut clockwise to secure it. INLET Sampling tube SUS sampling tube set (Option) The SUS sampling tube set provided contains a sampling tube (2×3 dia. length 100 mm), nut and packing (total 2 pieces).

  • Page 28: Connecting The Drain Tube

    Preparation Connecting the Drain Tube The drain tube set provided contains the drain tube (2×3 dia. length 1500 mm) and a pack- ing. They need to be mounted according to the following procedure. 1. Open the syringe-cover and insert the packing in the valve OUTLET. Note The packing is provided in both the sampling tube set and the drain tube set and each one has a distinctive size.
  • Page 29 Preparation 2. Connect the drain tube to the valve OUTLET and lightly fasten the connector to secure it. Connector OUTLET Valve Drain tube Important Please do not over-tighten the connector. The valve can be damaged if the connector is over-tightened. 3.

  • Page 30: Connecting The Keyboard And Mouse

    Preparation Connecting the Keyboard and Mouse 1. Connect the keyboard lead provided to the KEYBOARD connector on the rear panel of the unit. KEYBOARD connector Connector Keyboard 2. Connect the mouse lead provided to the MOUSE connector on the rear panel of the unit.

  • Page 31: Connecting Power Cord

    Preparation Connecting Power Cord 1. Turn the power switch to OFF. 2. Insert the connector of the power cord provided to the POWER connector on the unit and insert the plug into the AC outlet. POWER connector Connector AC outlet Plug WARNING To reduce risk of electrical shock, connect the power...

  • Page 32: Connecting The Printer (Local Printer)

    Preparation Connecting the Printer (Local Printer) 1. Connect the printer cable to the PRINTER connector on the rear panel of the unit. Note Only printers supporting Post Script Level 2 and above can be used. Basic set up is completed when the unit is shipped from the factory.

  • Page 33: Connecting To A Network (Lan Cable)

    Preparation Connecting to a Network (LAN Cable) 1. Connect a LAN cable to the ETHERNET connector on the rear panel of the unit. Note Make sure the ETHERNET connector correspondents to 10BASE-T. To network ETHERNET connector...

  • Page 34: Connecting The External Display

    Preparation Connecting the External Display 1. Remove the cable of the built-in display from the DISPLAY connector on the rear panel. DISPLAY connector 2. Connect the cable of the external display to the DISPLAY connector on the rear panel. LCD switch DISPLAY connector 3.

  • Page 35: Electromagnetic Stirrer (Option)

    Plug Control cable connector Control cable Electromagnetic stirrer Installed in the sample stand of the KL-04. Control cable The plug connects to the control cable connector on the controller with. Controller Turns the power supply ON or OFF and adjusts the revolution speed of the stirring bar by rotating the volume dial.

  • Page 36: How To Install

    Preparation How to install 1. Put the control cable downward through the hole of the sample stand and set the electromagnetic stirrer in the sample stand. 2. Push the sample container plate down on the sample stand to secure it.
  • Page 37 Preparation 3. Connect the control cable plug of the electromagnetic stirrer to the control cable connector of the controller. Controller Plug Control cable connector Control cable Caution The controller must not come into contact with any fl uid. If the controller is in contact with fl uid, an electric shock as well as malfunction of the unit can occur.

  • Page 38: How To Use

    Preparation How to use 1. Ensure that the volume dial on the controller is turned OFF. Completely turn the volume dial to the left until it stops as per the diagram on the right. 2. Connect the power cord to the AC outlet. speed 3.
  • Page 39 Preparation Note The correct sample container size appropriate to the volume of the sample fl uid must be used. A container with less internal diameter and a fl at bottom is preferred. A container with less internal diam- eter is more effi cient in agitation, when the capacity is the same. 4.

  • Page 40: Window Operation

    Window Operation Virtual Desktop Virtual Desktop The unit contains multiple virtual screens but only one of them appears on the actual display, as per the diagram on the right. When displaying multiple windows on a screen, the windows overlap each another and it may become con- fusing to use.
  • Page 41 Window Operation How to select a screen appearing on a display A screen appearing on a display can be selected by the following three methods. Drag the frame on the “Virtual Desktop” up to the screen you want to display. Double-click the screen on the “Virtual Desktop”...

  • Page 42: Window Menu

    Window Operation Window Menu The window menu can be displayed by clicking the left or right button on the window menu button ( ), which is on the header of window. The window menu displays the window’s possible operations. Note The window menu can also be displayed by clicking with the right mouse button on the header or the frame of window.

  • Page 43: Pop-Up Window

    Window Operation Pop-up Window The base window opens when you log on. Sometimes the pop-up window opens as well as the base window, depending on the user’s operation or the operational condition of the unit. The pop-up window is dependent on the base window. Therefore, if the base window is closed when the pop-up window is open, the pop-up window will also be closed.

  • Page 44: Changing The Overlap Order Of The Windows

    Window Operation Changing the Overlap Order of the Windows As windows can overlap each other it is usual that a part or the whole of a window will be hidden by other windows. When part of window is hidden by another window, click on the header or the frame of that window.

  • Page 45: Changing The Window Size

    Window Operation Changing the Window Size The size of window can be changed by dragging its resize corners (the L-shaped marks on the corner) to the size you want by holding down the left mouse button and then releasing Note If a window does not have resize corners, the size of the window cannot be changed.

  • Page 46: Closing Windows

    Window Operation Closing Windows Quitting window If the window has buttons such as “Quit” and “Dismiss”, the window can be closed by clicking these buttons. If the window does not have these buttons, selecting “Quit” from the window menu can close the window. Some windows open a pop-up window when closing and require confi rmation.
  • Page 47 Window Operation Quitting pop-up windows Most of the pop-up windows of the KL-04 have a “Dismiss” button on the bottom and the pop-up window can be closed by clicking the button. Some windows have a “Cancel” button instead of a “Dismiss” button, which has almost the same function.

  • Page 48: Start Up

    Start Up Power ON 1. Turn the POWER switch at the back of the unit ON. The Start Up screen appears, scrolling across the front crystal display. After a while, the LOGIN screen appears. Session menu: This menu is used for maintenance. Login by selecting “Failsafe” from the menu, which starts the unit in maintenance mode.
  • Page 49 Start Up Language Menu: Immediately after registering a new operator, “English” is set by de- fault as the display language. This menu can be used by any operator to change the display languages. Click to bring up the submenu, then select the appropriate language category, and then click on the required display language.

  • Page 50: Login

    Please re-enter the Login name and the password. After the Firmware version number is displayed on the screen, “Virtual Desktop”, the “KL-04 Controller” window and the “KL-04 - Measurement” window appear. Virtual Desktop KL-04 Controller window KL-04 - Measurement window “Virtual Desktop”:...

  • Page 51: Workspace Menu

    Click the right mouse button on the display background (where no window is displayed) to show the “Workspace” menu. The “Workspace” menu is used to show the “KL-04 - Start New Window” window or “Find Window” on the front of the display hidden by overlapping.

  • Page 52: Kl-04 - Start New Window

    Function Click each button on the “KL-04 - Start New Window” window to open the following windows. The reference pages indicate functional details and relevant information.
  • Page 53 The “Administration Tasks” window appears. Click for network and printer settings. See page 113. “Audit Trail” button: The “KL-04 - Audit Trail” window appears. Operators who have the required ac- cess privileges can view the audit trail. See page 127. Miscellaneous: “Change Password”...

  • Page 54: Change Displayed Language

    To register or change a password, follow the sequence below. 1. Display the “KL-04 - Start New Window” window. 2. Click the “Change Password” button in the “Miscellaneous” menu on the “KL-04 - Start New Window” window. The “Input” pop-up window appears.

  • Page 55: Completion (Logout) Method

    Click the “OK” button to close the window and repeat the sequence from No. 4. Completion (Logout) Method 1. Click the “Logout” button on the “KL-04 Controller” window. A logout confi rmation pop-up window appears. Click the “Logout” button on the window to return to the Login screen.

  • Page 56: Operator Management

    Register, an Operator using the following sequences, to set up other operator’s registration and access authorization. 1. Input the login name provided by RION in the “Login” space on the login win- dow. The “Login” space display will change to a “Password” space.
  • Page 57 Note The login name and the password provided by RION are com- mon to all KL-04 products. We recommend that you change the password and the login name provided by RION after registering an operator who has the “Operator Management” access autho- rization.

  • Page 58: Add Operator

    1. An operator with access privileges to “Operator Management” must log in and then display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Operator Management”...

  • Page 59: Change Of Operator Registration Details

    1. An operator with access authority for “Operator Management” must log in and then display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click on “Operator Management” from the “Management Tasks”...

  • Page 60: Kl-04 - Operator Management Window

    Operator Management KL-04 - Operator Management Window The each item description on the “KL-04 - Operator Management” window is as follows: Operator: Select an operator (displayed with “Login name” + “Full name”) in order to display the setting details on the “KL-04 - Operator Management”...
  • Page 61 Operator Management Permitted Management Tasks The level of authorization to undertake Management Tasks for each individual operator may be set. When setting the access rights (authorization), put check marks in the check boxes. Performance Test: Permit Performance-Test tasks Calibration: Permit Calibration tasks Set Measurement Parameter: Permit the Measurement Parameter setting tasks.
  • Page 62 Operator Management Change Other Operator’s Password: Other operator’s passwords can be deleted, or they can be prevented from logging in. If Operator Management is permitted, this is accessible. Set Clock: Permit authorization for the setting of the system clock. System Administration: This will permit network setting and printer setting tasks.

  • Page 63: Measurements

    Measurements Basic Operations The following are this unit’s operation samples. Number of Pre-Measurements START Tare Volume 2 mL Pre- Measurement Measurement Measurement Drain Number of Measurements Measurement Measurement Volume 5 mL Drain After Every Measurement? : Measuring Operation When ‘Drain After Every Measurement?’ is not set, and the combined total of Pre-Suction (i.e., Tare) Volume and total measured volume (total of the measured volume per single measurement ×...

  • Page 64: Measuring Sequence

    1. Display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Measurement” button from the “Usual Operations” menu on the “KL-04 - Start New Window”...
  • Page 65 Important When operating by pressing the “FLUSH” and “START” buttons on the unit, ensure that the “KL-04 - Measurement” window is set in an active window in which the required Measurement Parameter name is displayed. If it is not in an active window, operations may be different from the specifi ed Parameter.

  • Page 66: The Measurement Result

    Measurements The Measurement Result Pre-Measurement 1st Measurement 2nd Measurement 3rd Measurement Approval / Result Result Result Result Rejection judgement Average Measurement Parameter name Channel Bar graph display of the result Management Information Pre-Measurement Result Click the Show button to display the menu and then click ‘Show Pre-Measurement Data?’ from the menu to display it.

  • Page 67: To Display Previously Measured Data

    Note Immediately after the measurement, the latest Measurement Data appears. 1. Press the “Show” button on the “KL-04 - Measurement” window to show the menu. Select “List of Data” from the menu. The “Measurement - Data Selector” window appears. 2. Select required measured data year and month from the “Year & Month” list and the date from the “Date list”.

  • Page 68: Measurement - Data Selector Window

    Measurements Measurement - Data Selector window The explanation of each item on the “Measurement - Data Selector” window is as follows; Operator: When a measured result by each operation is required, check the box. With this, the operator name shown on the right hand side becomes effective.

  • Page 69: Measurement Parameter Setting

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click on “Measurement Parameter” from “View/Set Operating Parameters” menu on the “KL-04 - Start New Window”...
  • Page 70 Measurements 4. Enter the Measurement Parameter name in the space below “Measurement”. 5. If required, enter fi gures or checks in the Measurement Parameter space. Note See page 56, “Measurement Parameter” for the explanations of each Measurement Parameter. 6. Click the Register button. 7.

  • Page 71: Change Measurement Parameters

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Measurement Parameter” button from “View/Set Operating Parameters”...

  • Page 72: Measurement Parameters

    Measurements Measurement Parameters See the “KL-04 - Measurement Parameter” window for the Measurement Parameter. The explanation of each parameter is as follows; Syringe Syringe Volume (mL): This is to set the volume of the syringe which is installed on this unit.
  • Page 73 Measurements Aspiration Flow Rate (mL/min): This refers to the syringe suction velocity. This is to set the sample fl ow rate of the sensor. The standard products are set to 25 mL / min (10 mL / min : Factory option).
  • Page 74 Measurements Number of Pre-Measurements (times): Set the number of Pre-Measurements to be carried out prior to the actual Measurement. Usually a Blank Measurement (Blank Check) is carried out after the cleaning prior to a measurement. This enables the inside of the fl ow channel to become fully clean.
  • Page 75 The allowable setting range is 1.0 to 100.0 (0.1 times step). Clear “No.” Field at Measurement Start?: Clear the numeric value in the “KL-04 - Measurement” window at the measurement starting. Note When this item is not checked, the number (when entered) in the “No.”...
  • Page 76 “View” button: This enables checking the selected Performance-Test data. Select the required Performance-Test data name from the list then click this button. The “KL-04 - Performance-Test” window appears. Effective Period: This sets the validity period for the use of the Performance-Test data.
  • Page 77 Check to enable the setting of the ‘Set Upper Limit?’. The particle counts set here become the acceptance / rejection judgement criteria for the measured data. The judged result will be displayed on the acceptance / rejection result space on the “KL-04 - Measurement Data” window. “Set” button: Click this after setting the particle size.
  • Page 78 Measurements “Edit” button: Use this to change the particle size or upper limit setting. Select a required particle size channel from the “Channels” list to edit. Click to display the “Edit Channel Setting” window. Note The “Edit Channel Setting” window setting is the same as the set- ting on the “Add New Channel”...

  • Page 79: Performance-Test

    1. An operator with access privileges to “Performance Test” must log in and then display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method.
  • Page 80 Performance-Test 2. Click the “Performance Test” button from the “Usual Operations” menu on the “KL-04 - Start New Window” window. The “KL-04 - Performance Test” window appears. 3. Click the required Parameter name as shown at the right of “Perfor- mance Test”.
  • Page 81 Important When operating by pressing the “FLUSH” and “START” buttons on the unit, ensure that the “KL-04 - Performance Test” window is set in an active window in which the required Performance-Test Parameter Name is displayed. If it is not in an active window, the operations may be different from the specifi ed Parameter.

  • Page 82: The Performance-Test Result

    Performance-Test The Performance-Test Result Performance-Test Parameter Calibration Data Approval / Rejection Judgement Management Information Management Information Click the “Show” button to display the menu and then click ‘Show Management Informa- tion?’ from the menu to display it.

  • Page 83: Performance-Test Parameter Setting

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Performance-Test Parameter” button from the “View/Set Operation Parameters”...

  • Page 84: Changing The Performance-Test Parameters

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Performance-Test Parameter” button from the “View/Set Operation Parameters”...

  • Page 85: Performance-Test Parameters

    Performance-Test Performance-Test Parameters The Performance-Test Parameters are displayed on the “KL-04 - Performance-Test Pa- rameter” window. The defi nition of each Parameter is as follows; Syringe Syringe Volume (mL): Volume of the syringe installed on this unit can be set.
  • Page 86 Performance-Test Message KL-04 - Performance Test screen (when the aspiration fl ow rate is mismatch) Drain Flow Rate (mL/min): This refers to a syringe Drain Flow Rate. Set it with account to a sample’s viscosity etc. The allowable setting range is 1 to 100 mL / min (1 mL / min step).
  • Page 87 Performance-Test Number of Pre-Measurements (times): This enables setting of the number of repetitions of the Pre-Measure- ment prior to the Measurement. As the measuring sample may not necessarily be evenly distributed, It is therefore necessary to set the inside channel to the sample number concentration level.
  • Page 88 Please note that an incorrect data selection will not enable you to carry out a correct Performance-Test. The following data are registered at the dispatch of this unit. KL-04_Basic: Calibrated according to a method in line with RION’s specifi ed method. JPxx: Calibrated according to a method in accordance with the Japanese Pharmacopeia (JP).
  • Page 89 Performance-Test Effective Period: Set the effective period for the application of the calibration data. The allowable setting range is between 1 to 9999 days. Important If the Effective Period for the set Calibrated Data has expired, an error occurs during the measurement which disables the measurement.
  • Page 90 Performance-Test Average Diameter (µm): This is to set the PSL size for the test particles to be added. Set it within the system permitted size range of countable particles of 1.3 to 100 µm (0.1 µm step). Subtract CV for the Resolution?: Select this when the CV value(s) of the particles shall be subtracted calculating for resolution calculating CV of the PSL (%):...
  • Page 91 Performance-Test “Delete” button: Use this to delete the PSL size for the test particles. Select the PSL size from the “PSL (General)” list to be deleted. Click the PSL size to delete. Permissible Sensor Resolution (%): Set the Permissible Sensor Resolution. The allowable setting range is 1 to 50% (1% step).
  • Page 92 Performance-Test Suspension Use Suspension for Performance-Test?: Carry out the Particle Counting Accuracy stipulated by the USP. Select this to use the Suspension. Use Blank Bottle?: Select this to measure and subtract the Blank Bottle counts (which is part of the Performance-Test set of USP). Lower Threshold (µm): Set the lower threshold.

  • Page 93: Calibration

    Calibration When shipped from the factory, a maximum of four possible types of calibration (includ- ing options) have been carried out and the results are already registered as Calibration Data. These data serve as reference values that determine the setting (threshold) values for particle classifi cation (size per channel) during measurement.

  • Page 94: Calibration Sequence

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the Calibration button from the “Usual Operations” menu on the “KL-04 - Start New Window”...
  • Page 95 Calibration 4. Click the “Show” button from the “KL-04 - Calibration” window, then select the required Calibration Parameter. The “KL-04 - Calibration Parameter” window will appear. Check the details. Upon completing the check, press the “Quit” button to close the window.
  • Page 96 Important When operating by pressing the “FLUSH” and “START” buttons on the unit, ensure that the “KL-04 - Calibration” window is set in an active window, in which the required Calibration Parameter Name is displayed. If it is not in an active window, operations may be different from the speci- fi ed Parameters.
  • Page 97 Calibration 9. If other size calibration is required for one after another, repeat the sequence from No. 6 to No. 8 for the number of calibrating particle sizes. Upon completion of the calibration, click the “Register” button to register the calibration result.

  • Page 98: The Calibration Result

    Calibration The Calibration Result The actual calibration parameters will be displayed. Click on the “Show” button and select “Show Management Information” to display man- agement information. The calibration result for an individual particle size The Blank Measurement, and the Calibration result for each calibrated particle size, will be displayed with a graph.
  • Page 99 Calibration Calibration Curve Click on the “Show” button and select “Show Calibration Curve” to display the calibra- tion curve. Management Information Click on the “Show” button and select “Show Management Information” to display man- agement information.

  • Page 100: Display Calibration Data

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Calibration” button from the “Usual Operations” menu on the “KL-04 - Start New Window”...

  • Page 101: Calibration Parameter Setting

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Calibration Parameter” button from the “View/Set Operation Param- eters”...

  • Page 102: Change Calibration Parameter

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Calibration Parameter” button from the “View/Set Operation Param- eters”...

  • Page 103: Calibration Parameter

    Calibration Calibration Parameter The Calibration Parameter is displayed on the “KL-04 - Calibration Parameter” window. The explanations for each parameter are below. Calibration: Select a Calibration Parameter to show its setting details. When a new Calibration Parameter Setting is required, enter the cali- bration parameter in the space below “Calibration”.
  • Page 104 Calibration Measurement Aspiration Flow Rate (mL/min): This refers to the syringe’s suction rate. This sets the rated fl ow rate of the unit. The allowable setting range is 5 to 100 mL / min (1 mL / min step). Important The aspiration fl ow rate set in the Calibration Parameter must be the same as the aspiration fl ow rate for the Performance Test Parameter.
  • Page 105 Calibration Measurement Volume (mL): Set the volume for the particle measurement. The allowable setting range is [(0.2 to syringe volume) – (Tare Volume + 0.2 mL)] (0.1 mL step). For the standard 25 mL syringe, the range is 0.2 to 24.7 mL. Number of Pre-Measurements (times): Set the number of Pre-Measurements prior to the actual measurement.
  • Page 106 Calibration PSL List: A window for the registered calibration PSL sizes will be displayed. “Add” button: Click this to add a PSL size for calibration. The allowable PSL size channel is up to twenty (20). Click to display the “Add New PSL” window. Average Diameter (µm): This is to set the PSL size for the calibration particles to be added.
  • Page 107 USP: This is the calculation method stipulated in the United States Pharmacopeia. Adaptive: This is the calculation method stipulated by RION Co., Ltd. “Set” button: Click after setting the PSL size for the calibration particles. The “Add New PSL” window closes, then a PSL size list is added to the “PSL”...

  • Page 108: Print

    Print Printouts are available in the following sequence for Measurement Parameter, Perfor- mance-Test Parameter, Calibration Parameter, Measured Result, Performance-Test Result, Calibration Result, Operator Setting and Audit Trail. Note Please ensure the printer is properly connected before printing. See “Connecting the Printer (Local Printer)” on page 16. Connection to a printer connected to a network is available.
  • Page 109 Print 4. Click the “Paper Size” button and select the desired paper size from the list that appears. Click the “Destination” button and select the destination printer or output to fi le from the list that appears. To show the Signature Section in the print result (page 96), put a check mark in the “Show Signature Section”...
  • Page 110 However, the temporary error window will appear for each operator separately. Printing from KL-04 - Measurement window When you click the “Print” button in the “KL-04 - Measurement” window, you can select one of two printing methods: “Print...” and “Print This Data”. If you select “Print This Data”, the window shown on page 92 will not appear, and the previously selected settings...

  • Page 111: Ps Files

    There are no special requirements regarding power-on sequence and connection sequence. 2. Enter the IP address, log-in name, and password for the KL-04 in the FTP client to connect to the KL-04. 3. Use the FTP client to copy any PS fi les in the /home/log-in name/temp directory (or in the /home/Audit Trail/temp directory for audit trail fi les) to the computer.

  • Page 112: Print Samples

    Print Print Samples Measurement Parameter KL-04 Measurement Parameter Page 1 of 1 Measurement Parameter: #1: KL 04 Basic for RION’s Staff Revision: 22 Creation Date: 2001 10 02 10:29:56 Operator: RION’s Staffs (rion) Instrument: KL 04 No.00710003 (kl 04 0003)
  • Page 113 Print Performance-Test Parameter KL-04 Performance-Test Parameter Page 1 of 1 Performance Test Parameter: #1: KL 04_Basic Revision: 12 Creation Date: 2001 10 02 09:48:42 Operator: RION’s Staffs (rion) Instrument: KL 04 No.ABC (kl 04 0003) Syringe Syringe Volume: 25 mL...
  • Page 114 Print Calibration Parameter KL-04 Calibration Parameter Page 1 of 1 Calibration Parameter: #1: KL 04_Basic Revision: 6 Creation Date: 2001 10 02 11:09:28 Operator: RION’s Staffs (rion) Instrument: KL 04 No.00710003 (kl 04 0003) Syringe Syringe Volume: 25 mL Measurement...
  • Page 115 Print Measurement Result KL-04 Measurement Data Page 1 of 1 Date: 2001 10 16 19:06:26 Operator: RION’s Staffs (rion) Sample: No.: Measurement: #3: USP24 (Rev. 4) Flow Rate: 25 mL/min Measurement Volume: 5 mL Unit Volume: 1 mL Dilution Ratio: ×1 Instrument: KL 04 No.00710003 (kl 04 2)
  • Page 116 Print Performance-Test Result KL-04 Performance-Test Data Page 1 of 2 Performance Test: #1: KL 04_Basic Revision: 6 Creation Date: 2001 10 02 11:17:38 Operator: RION’s Staffs (rion) Instrument: KL 04 No.00710003 (kl 04 0003) Performance Test Parameter Performance Test: #1: KL 04_Basic (Rev. 12)
  • Page 117 Print Calibration Result KL-04 Calibration Data Page 1 of 6 NOT REGISTERED Calibration: #1: KL 04_Basic Creation Date: 2001 12 18 13:23:07 Operator: Setup KL 04 (setup) Instrument: Calibration Parameter Calibration: #1: KL 04_Basic (Rev. 6) Aspiration Flow Rate: 25 mL/min...
  • Page 118 Print Operator Setting KL-04 Operator List Page 1 of 1 Instrument: KL 04 No.sisaku No.3 (kl 04 3) #501: rion (RION’s Staffs) Normal #502: service (Authorized Service Center) Normal #503: admin (admin) Normal #504: setup (Setup KL 04) Normal #505: kangi (kangi)
  • Page 119 2006-04-03 09:49:06 JST-9:0 test operator log-in localhost 2006-04-03 09:51:03 JST-9:0 test operator log-out localhost 2006-04-03 09:51:21 JST-9:0 RION’s Staffs (rion) operator log-in localhost 2006-04-03 09:55:38 JST-9:0 RION’s Staffs (rion) file create /home/kl04/share/perf/conf/1/3 2006-04-03 10:06:16 JST-9:0 RION’s Staffs (rion) file create /home/kl04/share/perf/data/1/2 2006-04-03 10:07:33 JST-9:0 RION’s Staffs (rion) file create /home/higashi/data/y2006/m04/d03/100658...

  • Page 120: Export The Measured Data

    1. Insert a fl oppy disk into the front fl oppy disk drive. 2. Select the “List of Data” from the menu displayed when the “Show” button is pressed on the “KL-04 - Measurement” window. “Measurement - Data Selector” window appears.
  • Page 121 7. Click the “Dismiss” button. Remove the fl oppy disk. Data sample See data samples transferred to fl oppy disks. DATE 2001-10-16 19:06:26 OPERATOR RION’s Staffs (rion) INSTRUMENT KL-04 No.00710003 (kl-04-2) SAMPLE NUMBER MEMO MEASUREMENT #3: USP24 (Rev. 4) SAMPLE-VOLUME PRE-MEASUREMENT...
  • Page 122 OPERATOR: Measurement operator name INSTRUMENT: Measurement instrument number SAMPLE: Characters entered in the “Sample” of “KL-04 - Measurement” window NUMBER: Number(s) entered in the “No.” of “KL-04 - Measurement” window MEMO: Letters input to “Memo:” of “KL-04 - Measurement” window...

  • Page 123: Back Up

    1. An operator with access privileges to “Backup/Restore” must log in and then display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method.
  • Page 124 Back Up 2. Click the “Backup/Restore” button from the “Management Tasks” menu on the “KL-04 - Start New Window” window. The “KL-04 - Backup/Restore” window appears. 3. Insert the tape cartridge into the tape drive located at the front of the unit.

  • Page 125: Restore

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Backup/Restore” button from the “Management Tasks” menu on the “KL-04 - Start New Window”...

  • Page 126: System Setting

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Set Clock” button from the “Management Tasks” menu on the “KL-04 - Start New Window”...
  • Page 127 System Setting 4. Click the “Set” button. The confi rmation message appears. 5. Click the “Yes, Set the Clock” button. A message appears recommending a logout. 6. Click the “Dismiss” button to close the message. 7. Log out then log in again. Important After setting the clock, you should quickly log out and then log in again.

  • Page 128: Kl-04 - Set Clock Window

    System Setting KL-04 - Set Clock Window The details of the items on the “KL-04 - Set Clock” window are as follows; Time Zone: Input the appropriate time (i.e., to use this unit) in the designated space. Offset (hours): Input the time difference between the setting region and the UTC.

  • Page 129: Network Settings

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “System Administration” button from the “Management Tasks” menu on the “KL-04 - Start New Window”...
  • Page 130 “Hostname” menu. Note At the time of shipment, “KL-04-xxxx” (xxxx is the last four digits of the serial number) is set up as the host name. When a change of host name is required, fi rst input all the Network settings then logout.
  • Page 131 System Setting 8. Click the “Hosts” button then click the “Add” button. The “Edit/etc/hosts” window appears. 9. Input the IP address (inputted in step 7) to the “IP” space, and the host name (inputted in step 4) to the “Name” space. If required, input a nickname to the “Nicknames”...

  • Page 132: Settings For A Printer Connected To The Network

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “System Administration” button from the “Management Tasks” menu on the “KL-04 - Start New Window”...
  • Page 133 System Setting 4. Click the “Add” button. The “Add a Printer Entry” window appears. 5. Select “Remote Unix (lpd) Queue” from printer types shown on the “Printer type” then click the “OK” button. The “Edit Remote Unix (lpd) Queue Entry” window appears. 6.
  • Page 134 System Setting 7. Click the “Select” button. The “Confi gure Filter” window appears. 8. Select PostScript printer from the “Printer Type” list then click the “OK” button. Note Please do not change the other settings. The “Confi gure Filter” window closes and returns to the “Edit Remote Unix (lpd) Queue Entry”...

  • Page 135: Useful Tools

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Virtual Keyboard” button from the “Unsupported” menu on the “KL-04 - Start New Window”...

  • Page 136: Tksnapshot

    “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window” window display method. 2. Click the “Screen Snapshot” button from “Unsupported” menu on the “KL-04 - Start New Window”...
  • Page 137 Useful Tools 5. Click or drag on areas of the screen, matching the item selected in “Snap Type”. Note Window: Click anywhere on the desired window. Region: Drag over the desired region. Screen: Click anywhere on the display. 6. Click the “Save” button. The “TkSnapshot - Save”...

  • Page 138: Tksnapshot (Version 0.31) Window

    Useful Tools TkSnapshot (Version 0.31) Window Load button: Displays stored screen images in the window. Click to show the “TkSnapshot - Load” window. Select the required fi le name from the list and click the “Load” button, then click the “View” button. Save button: This saves captured window images on the hard disk.

  • Page 139: The Tksnapshot - Save Window

    Useful Tools Hide Window During Capture: This enables the user to hide the “TkSnapshot (Version 0.31)” window after clicking the “Snap” button until the screen image is actually captured. The “TkSnapshot (Version 0.31)” window reappears once the screen image is captured. Snap button: To capture screen images.
  • Page 140 Useful Tools Format: This is to select a fi le format for a screen image to be stored. When “Automatic” is selected, the fi le format is determined according to the fi le name extension inputted in “Save as”. When no extension is entered, it will be stored as a XWD format. Note When the fi le format specifi ed in “Format”...

  • Page 141: Audit Trail

    “21 CFR Part 11: Electronic Records; Electronic Signatures” by the American FDA. The KL-04 continuously records operation history data (when/who/which operation). These data can be displayed, searched (by time period, operator, class, event), and the display contents can be printed.

  • Page 142: Operations Recording In The Audit Trail

    Audit Trail Operations recording in the audit trail For operations listed in the table below, audit trail information is recorded at the point where the operation is completed, or where the fi le is created in the case of operations that create a fi le upon completion.

  • Page 143: Format For Recorded Items

    Operation Note Changed item, measurement data fi le name, etc. The recording format is as follows. (Example: log-in event) Time zone Date Time 2006-04-03 09:48:44 JST-9:0 Rion's Staffs (rion) operator log-in localhost Note Operator name Time stamp Class Event Note For the power-on and power-off events, the operator name is always “root”.

  • Page 144: Searching And Viewing The Audit Trail File

    Audit Trail Searching and Viewing the Audit Trail File 1. Log in as an operator with “Audit Trail” access privilege, and display the “KL-04 - Start New Window” window. Note See page 34 for the login method and see page 36 for the “KL-04 - Start New Window”...
  • Page 145 “Dismiss” button. • This is shown when the search failed. Turn power to the KL-04 off and then on again. Log in again and repeat the search. Close the window by clicking the “Dismiss” but- ton. If the same message window appears again, there may be a problem with the...

  • Page 146: Audit Trail Backup And Restore

    Audit Trail Audit Trail Backup and Restore The audit trail information is always included in a backup. During restore, the audit trail fi le will not be overwritten. When restore has been performed, an asterisk (*) will be shown to the left of the audit trail item, which indicates that the item pertains to the condition before restore.

  • Page 147: Maintenance

    Maintenance Syringe Replacement Important The syringe may wear out. If foams appear from the sliding piston during suction or when sample liquid is leaking while draining, please replace the syringe. 1. Click the “FLUSH” button to start the operation. 2. When the plunger has drawn 15 to 20 mL, open the syringe cover then stop the operation (the plunger stops at that position).
  • Page 148 Maintenance 5. While pressing the syringe lightly with one hand, remove the fi xing crew on the lower side of the syringe with the other hand. Fixing screw 6. While pressing the syringe lightly with one hand, lower the syringe outer chamber by turning it left with the other hand.
  • Page 149 Maintenance 8. Insert the new syringe into the clamp, with the clamp pin on the left hand side and the C-shaped open area to the front. Clamp Syringe 9. Insert the screw area of the new syringe into the syringe fi xing hole on the valve. While pressing the syringe lightly with one hand, turn the syringe outer chamber right to install it.
  • Page 150 Maintenance 11. Adjust the position by turning the clamp little by little so that the pins make con- tact with the left hand side of the wall surface in which the syringe is to be fi xed. Once it is fi xed, tighten the screw while making sure that the pin is in the correct location.

  • Page 151: Handling The Syringe

    Maintenance Handling the Syringe The sealed piston of the KL-04 Syringe can easily be damaged as it is made of Tefl on. Please make sure to follow the instructions below in order to maintain the syringe in op- timum condition for as long as possible.

  • Page 152: Noise Level Check And Flow Cell Cleaning

    / fi gures on the “KL-04 Controller” window turn to orange. If this occurs during measurement, the “Bad Sensing Condition”...
  • Page 153 7. If the letters / fi gures on the “KL-04 Controller” window remain orange or the noise level is still high, clean using the cell cleaning brushes provided (see next page).

  • Page 154: Cleaning Using A Cell Cleaning Brush

    Maintenance Cleaning Using a Cell Cleaning Brush Use the attached cell cleaning brushes to clean the fl ow cell. Two cell cleaning brushes are provided in a special case. Cell cleaning brushes - 2 Case Cell cleaning brush portion Important Handle the cell cleaning brushes with care since they are easily bent.
  • Page 155 7. Supply pure water to the unit at the rated sample fl ow rate (25 mL / min, 10 ml / min for factory option). If the letters / fi gures on the “KL-04 Controller” window change to black, cleaning is complete. Check the noise level again according to the procedure on page 136 and confi rm the noise level has fallen.

  • Page 156: Periodic Maintenance

    Maintenance Periodic Maintenance In order to maintain continued measurement precision, it is recommended to have the unit checked and serviced once per year. Contact the supplier regarding periodic main- tenance. The Standardization of Units by the Regional Pharmacopeia The effective period is set for the standardization of the unit in every region (Calibration, Performance-Test).

  • Page 157: Troubleshooting

    “Sensor Degraded” warning message appears after the completion of the measurement. If the red letters / fi gures on the “KL-04 Controller” window or the “Sensor Degraded” warning message appear often, the laser diode may be damaged, or may have some problems.

  • Page 158: When Message Window Appears

    Troubleshooting When Message Window Appears The remaining free space on the hard disk drive in the KL-04 is low, or the hard disk has become full. Erase data that are no longer needed, or contact the supplier. When storing data at a rate of 100 per day, the hard disk of the KL-04 will not become full by measurement and other data alone over a period of 5 to 6 years.
  • Page 159 Troubleshooting This message appears when an attempt is made to perform more than 999 restore opera- tions in a single month. In this case, no more restore operations can be carried out. When the month changes, restore can be carried out again. Close the window by clicking the “Dismiss”...

  • Page 160: When Kl-04 Does Not Start Up Normally

    Troubleshooting When KL-04 Does Not Start Up Normally At the startup screen after turning power to the KL-04 on, a message such as shown below may appear, and the system does not start up normally. This may be due to a fi le system (recording medium data management method) problem related to the hard disk, causing the operating system to request a fi le check (fsck) in dialog mode.

  • Page 161: Specifi Cations

    Specifi cations Optical system Light-obscuration method Light source Laser diode (rated output: 3 mW, wavelength: 780 nm) Laser product classifi cation Class 1, IEC 60825-1 (2001) Class 3B laser is used in the internal particle detection mecha- nism. Light detector PIN type photodiodes Materials of component parts exposed to sample fl uid Sampling tube:...
  • Page 162 Specifi cations Instrument Standardization at each regional pharmacopeia (factory option) Calibration Particle size calibration using the calibrated particles of 1.3 to 100 µm which have domestic and international traceability have a margin of error of less than 3%. However, our own specifi ed method will be carried out for the calibration of less than 4 µm.
  • Page 163 Specifi cations Sample fl uid connectors INLET Sample fl uid inlet Sampling tube provided is to be connected to the INLET within the sensor area. OUTLET Sample fl uid outlet 2×3 dia. fl ange tube is to be connected to the OUTLET of the sy- ringe pump.
  • Page 164 Specifi cations Dimensions 369 (H) × 400 (W) × 280 (D) mm (maximum) 363 (H) × 360 (W) × 236 (D) mm (excluding protruding parts) Weight Approx. 14 kg Supplied Accessories PFA Sampling tube (2×4 dia., length 100 mm) set (includes a nut) Drain tube (2×3 dia., length 1500 mm) set (includes a connector and a piece of packing)
  • Page 165 Specifi cations Rear View Top View Left Side View Front View Right Side View Unit: mm Dimensional Drawings...
  • Page 166 No. 31947 06-11 Printed in Japan...

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