FIS OralChroma CHM-2 Instruction Manual

Halitosis measuring device

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OralChroma

HALITOSIS MEASURING DEVICE

CHM-2

Instruction Manual

Nissha FIS, Inc.

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Page 1 OralChroma HALITOSIS MEASURING DEVICE CHM-2 Instruction Manual Nissha FIS, Inc.
Page 2 * The contents of this manual are subject to change without prior notice. * The contents of this manual are protected by copyright law. * Unauthorized copying/reprinting of this manual is prohibited. COPYRIGHT (C) Nissha FIS, Inc. All rights reserved.
Page 3: Table Of Contents
Index Safety Instructions......................1 Precautionary Statements ....................2 Overview ........................... 4 Confirm supplied items ...................... 6 Names and Functions of Parts ..................7 Setting up the unit ......................9 Setting up the PC ......................10 Installing and starting up the OralChroma DataManager..........12 Importing data from the old version .................
Page 4: Safety Instructions
Safety Instructions WARNING Improper use of the unit may cause physical injury or unit malfunction. For your safety, carefully read and understand this Instruction Manual before you use the OralChroma. Please note that we are not liable for any accident unless the cause of the accident is clearly attributable to failure of the product.
Page 5: Precautionary Statements
Precautionary Statements The following precautionary statements must be observed in order to use the unit safely and to make the most of its functions: WARNING  Avoid damaging or abusing the power cord. A short circuit may cause variations in current, resulting in overheating and fire.
Page 6 Places where gas tends to accumulate, such as a low position near a floor. ・  This is a single-purpose oral breath-measuring unit. Never inject any material other than breath samples (E.g., liquid substances including chemicals, water, and saliva, or any kind of gas).
Page 7: Overview
Overview The OralChroma measures and classifies volatile sulfur compounds in human breath samples into three causal components (hydrogen sulfide, methyl mercaptan, and dimethyl sulfide), then displays each gas concentration on your PC. It is easy to use and requires only four minutes to analyze the sample.
Page 8 ■ Mechanism of measurement The following constitutes the procedure for measuring oral breath concentrations: Collect oral breath samples and inject the specified volume of gas into the column. Separate volatile sulfur compounds from the gas by using the column and detect the gases with the semiconductor gas sensor.
Page 9: Confirm Supplied Items
Confirm supplied items When you receive the OralChroma, immediately check for any damage or abnormal conditions caused during delivery. Check thoroughly to ensure that all accessories are included. If there should be any missing components, damage, or malfunctions, i.e., the unit does not operate according to specifications, contact the agent from whom you purchased the unit.
Page 10: Names And Functions Of Parts
Names and Functions of Parts ■ Power switch POWER lamp Gas inlet ERROR lamp READY lamp ■ Rear USB port AC power jack Fuse holder Main switch...
Page 11 ■ Functions Functions Place Name Manually open/close Usually closed to prevent dust from coming into gas inlet. Inject oral gas sample into this inlet with a Gas inlet supplied syringe. Power on/off the unit. Power Keep pushing until buzzer sounds. switch Orange light comes on when power is turned POWER...
Page 12: Setting Up The Unit
Setting up the unit ■ How to set the unit before measurement. Place the unit on a flat and stable place. CAUTION Position the OralChroma unit so that power cord and USB cable can be easily connected to or disconnected from the unit. Connect power cord to the unit, then to receptacle of AC supply.
Page 13: Setting Up The Pc
Setting up the PC You need a personal computer (PC) and the supplied CD including “OralChroma DataManager” software to start measurement. Prepare the PC specified below by yourself. ■ System requirements Windows XP（SP3）、Windows Vista(32/64bit), Windows 7(32/64bit), Windows 8(32/64bit) Hardware on which the above OS runs without problems. Computer XGA(1024×768) or higher Display...
Page 14 ■ Installing USB driver software Power on the PC and start Windows. Insert the supplied CD into the CD drive. When the set up window appears, click “USB driver.” Follow the directions displayed on the window to proceed with the installation. When the window below appears, click OK to complete the installation.
Page 15: Installing And Starting Up The Oralchroma Datamanager
Installing and starting up the OralChroma DataManager ■ Installing OralChroma DataManager Insert the supplied CD into the CD drive. The setup program is automatically started. At this time, the warning window below may appear depending on your security status. If it does, click YES. When the setup window appears, click “OralChroma DataManager”...
Page 16 The following folder where the DataManager is installed appears. Double-click “CreateShortcutIcons” to create shortcut icons for DataManager and its manual on the desktop. Close the setup window. At this time, the confirmation window below may appear depending on your security status. If it does, click “This program installed correctly.”...
Page 17 ■ Starting OralChroma DataManager Double-click “OralChroma” shortcut icon on the Windows desktop. When you first activate the program after installation, a message “Select COM port.” appears. Click “OK.” The OralChroma DataManager top window appears as below. This window is referred to as “Main window.”...
Page 18: Importing Data From The Old Version
Importing data from the old version Data files between current and old version DataManager softwares are not compatible. If your PC has the old version, its data should be imported into the current version in advance. ■ How to import Click “System settings…”...
Page 19 Data importing window appears. Select “CHM-1” for “Data of” column. Click “Search the PC for CHM-1 data folder.”...
Page 20 When PC finds the CHM-1 data folder, it is automatically imported in the “Folder” column and the data are shown as below. Click “Import.” Note: If CHM-1 data folder cannot be found… When your OS is Windows Vista, 7, or 8, the CHM-1 data folder may not be found, depending on your security settings on the OS.
Page 21 After the data import is executed, the results are shown in “Import” column as below. The meaning of messages in “Import” column is as listed below. Completed (New ID ID and data of the old version were successfully created) imported. Completed (Added to Because old version’s ID exists in the current same ID)
Page 22: Initial Set Up Of Oralchroma Datamanager
Initial set up of OralChroma DataManager It is necessary to make the following setting for the DataManager before measurement. ■ Setting communication port number Setting the communication port number you connect OralChroma to. CAUTION When you first use OralChroma and DataManager, be sure to set the communication port number you connect OralChroma to before measurement.
Page 23 Click the drop-down list in “COM port” to specify the port number you connect OralChroma to. If no COM port appears, click ”Update COM ports” to update the status. If several ports are listed and the correct port No. is unknown, click “Device Manager” to confirm as below.
Page 24 ■ Setting data folder As a default, the folder where the measurement data are stored is a subfolder under the software installed folder. Select “General” tab in “System settings” window and click “Browse.” Specify the folder where the measurement data is saved in “Browse For Folder” window, and click “OK.”...
Page 25 ■ Setting user information column You can input your own clinic logo, information or message to display on the upper right space of “Judgment” window or on printed paper. OralChroma logo is shown as an initial setting. The message and/or logo is also displayed on the lower right of measurement data window and measurement history window.
Page 26 Click “Browse…” to specify the picture file you want to use. The image format that can be used is JPG, BMP, GIF, or PNG. The default image size is 320×100 pixels. For larger or smaller size images, DataManager automatically resizes the picture to fit within the default image size.
Page 27 ● How to insert the text Select “Print” tab in “System setting” window” and click “Text.” Click “Preview” box to enter text. Click “Font” to change font and color. Click “Back color” to change the background color.
Page 28 ■ Setting the judgment You can define the settings required for making judgments on the measurement value. ● Cognitive threshold Click “Judgment” tab in “System setting” window. Specify a threshold, a criterion for judgment, for each gas by clicking the up/down button. The unit is “ppb”...
Page 29 ● Editing judgment sentences Click “Judgment” tab in “System settings” window. Select one comment you want to change. Enter texts. The comment is changed by Enter or Tab key, or clicking the different cell in the table. There is no upper limit for the numbers of characters. But when the numbers of characters increases, the font size becomes small, then the comments become hard to recognize.
Page 30: Preparing For Measurement
Preparing for measurement ■ Connecting OralChroma to a PC For initial measurement, make sure to connect the OralChroma unit to a PC in this procedure. Because the connection in this procedure is not necessary after the initial measurement, start directly “Activating the unit”(page 28) excluding the following cases. ―...
Page 31 ■ Activating the unit Open lid and keep pushing “Power switch” until the buzzer sounds. After that all lamps turn on for 3 seconds, after that the orange POWER lamp will glow, indicating the unit status “Waiting.” After several seconds, confirm that Current status indicates “Waiting...”...
Page 32 This waiting time is usually set as 60 minutes maximum. Green READY lamp turns on when the status becomes “Ready to measure” after the sensor and column in the OralChroma is stabilized. CAUTION You can measure only when the green READY lamp on the unit is on. If you mistakenly inject the sample breath gas to OralChroma when the lamp is off, “Waiting”...
Page 33 ■ Registering subjects OralChroma DataManager manages the measurement data with registered IDs, names, etc. of subjects. Register the new subject or select the registered subject before the measurement. Turn on the PC to run OralChroma DataManager. Click “Measurement” on the Main window. The “Measurement data”...
Page 34 Follow the procedures below for registering new ID. Skip the procedure below for selecting already registered ID and go to [Selecting registered ID] or [Selecting registered ID from a list.] ● [Registering new ID] Enter new ID on “ID entry” window and click “Select.” Confirmation window for new registration appears.
Page 35 Enter the information of new subject. Details on fields are as below: Field Content Remarks ・Already registered ID cannot be registered. ・30 characters maximum Characters ・Prohibited characters: identifying subject \ / : * ? " < > | , ・Not case sensitive ・30 characters maximum Name Subject name...
Page 36 Click “Register” after filling fields. Confirmation window appears. Click “OK.” ● [Selecting registered ID] When entering character by character, the partially matched registered IDs are listed. Select one you want to use, then click “Select.”...
Page 37 ● [Selecting registered ID from a list] Click “Browsing list….” ID list appears. Select the subject and click “Select.” Click field name to sort the data in ascending or descending order.
Page 38 After completing ID entry, the specified subject data appears on “Measurement data” window and the OralChroma is ready to measure. CAUTION In case you inject the sample gas before clicking “Measurement” on Main window, Measurement data window with plotting data and ID entry window appear. Proceed ID entry as described above before completing the measurement, or the measured data will not be stored automatically.
Page 39: Measurement
Measurement Sampling oral gas and injecting it to OralChroma. ■ Sampling oral gas Take a syringe from the sealed bag. Insert the syringe into the oral cavity until the flange reaches the lips. Softly bite on the syringe to fix it and close the mouth tightly. Flange Plunger DANGER...
Page 40 WARNING  Always use a new and unopened syringe. When you open the package, use the syringe immediately.  Do not reuse the syringe. Doing so may cause infection. Used syringes shall be discarded according to the applicable laws of your country or region. ...
Page 41 After 30 seconds or more, pull the piston to the very end of the syringe, and fill the syringe with a breath sample from the oral cavity. Then push the piston and return the gas to the oral cavity. Pull the piston again to the very end of the syringe to fill it with another breath sample and this time remove the syringe from the oral cavity.
Page 42 ■ Injecting oral gas Confirm that “Inject oral gas” is displayed at upper right of “Measurement data” window and that green READY lamp of OralChroma is lit. Open the lid on top of OralChroma. Insert the tip of syringe at a right angle to the inlet and push down strongly on the plunger in one stroke to inject the entire breath sample into the OralChroma.
Page 43 Receiving data is plotted on “Measurement data” window, and the elapsed time is indicated at upper right. You can select the view mode, “Chromatogram” or “Simple” by right-clicking on the graph area. Chromatogram view mode Simple view mode...
Page 44 ■ Completing measurement The measurement time is 4 minutes. When the measurement is completed, buzzer sounds and OralChroma enters “Waiting” status for one minute. Measured data and results are saved in the file. The “Measurement data” window displays the chart and values of gas concentrations as below. Chromatogram view mode Gas concentration Simple view mode...
Page 45 Confirmation message “Measurement completed” appears. Click “OK.” The “Judgment” window is displayed with flashing the judgment result. For chromatogram view mode Judgment result For simple view mode CAUTION If no ID is specified in advance, no data is saved and no judgment is displayed.
Page 46 ■ Stopping measurement Click “Stop” button if you want to stop the measurement before completing. A buzzer sounds and OralChroma enters “Waiting” status for one minute. Green READY lamp is lit on the unit. CAUTION If the injected gas includes high concentration of halitosis gas components, the “Waiting”...
Page 47 ■ Receiving previous data One previous data is saved in the memory of OralChroma unit. You can receive this data. This is useful when the USB cable is mistakenly disconnected during measurement or measurement is started without running the software. CAUTION Once the measurement starts, the previous measurement data is cleared.
Page 48: Ending Measurement
Ending measurement Power off the OralChroma after ending the measurement. You can use the software even if the unit is off. ■ How to end measurement Keep pushing down on the Power switch of the unit until the buzzer sounds. The power is turned off with orange POWER lamp off.
Page 49: Viewing Measurement History
Viewing measurement history Measurement history can be displayed in the form of graph and list from the saved data. ■ How to view measurement history Click “Measurement history” on Main window. ”ID entry” window appears. Enter the ID of which you want to display the subject and click “Select”, or click “Browsing list…”...
Page 50 ■ Operating measurement history display ● Changing Y-axis scale Right-click on the graph area to move the pointer to “Y- axis range”, then select “Large”, “Small”, or “Auto.” ● Changing color Right-click on the graph area to move the pointer to “Graph color”, then select a gas or “Total amount.”...
Page 51 ”Color” window appears. Select a new color and click “OK.” Select “Reset” of Graph color to change all the colors to initial setting. The above color change will be applied to the software completely. The color change of one measurement history window reflects other measurement histories and measurement data windows.
Page 52 ● Changing unit and showing total amount Click drop-down list of “Unit” to select either “ppb” or “ng/10mL.” Check “Total amount” to display the total amount. Total amount is shown only when the unit is “ng/10mL.”...
Page 53 ● Changing graph type Click the drop-down list of “Graph” to select “Line” or “Bar.” The display below is a bar graph example. ● Displaying measurement data Double-click the row you want to display in the list of “Measurement history” window or select the date and click “Measurement data”...
Page 54 ● Exporting data Measurement history data can be saved as a text file in CSV format. Click “Export.” Enter the file name in the “Export measurement data” window and click “Save”. The saved file can be used for spread sheet software such as Excel. 【Saved file example】...
Page 55 ■ Creating image file and printing of measurement history The displayed window can be printed or saved as image file. ● Printing Click “Print” or right-click “Print” then select “Print” to show “Print” window. Click ”Print” after selecting printer and setting paper size, etc. * Selecting printer and setting paper size are stored and will be effective for the next printing automatically.
Page 56 ● Creating image file Right-click “Print” and select “Save as image file.” Enter the file name, select file type (jpg or bmp) and then click “Save.” ■ Managing measurement data The measurement data can be moved and deleted, and the subject data can be deleted. ●...
Page 57 Click “ID/Data” to select “Move data.” Confirmation message appears. Click “Yes.” Enter or select the correct ID in “ID input” window, then click “Select.” The data is moved from the wrong subject to the correct subject’s ID. *When the measurement history window for the correct subject ID is open at this time, close such window and re-open it to show the change.
Page 58 ● Deleting data Click the date or row in the list of “Measurement history” window to specify the data you want to delete. Click “ID/Data” to select “Delete data.” Confirmation message appears. Click “Yes.” The data file is deleted and data is removed from the displayed window. CAUTION Deleted data cannot be restored.
Page 59 ● Changing subject ID information You can change the registered information of the subjects. Click “ID/Data” to select “Change ID information.” Change the personal information in “ID information change” window, then click “Change.” Personal information on “Measurement history” and “Measurement data” windows are updated.
Page 60 ● Deleting subject ID You can delete the subject personal information and the measurement data at the same time. Click “ID/Data” to select “Delete ID and its data.” Confirmation message appears. Click “Yes.” After deleting the data, the measurement history window is automatically closed. CAUTION Deleted data cannot be restored.
Page 61: Measurement Data Window
Measurement data window The window displaying the measurement data has two viewing modes as below. Chromatogram view mode Gas detection point Sensor voltage graph Simple view mode...
Page 62 ■ Operating Measurement data window ● Changing View mode Right-click on the graph area to move the pointer to “View mode”, then select “Chromatogram” or “Simple.” ● Changing Y-axis range Right-click on the graph area to move the pointer to “Y-axis range”, then select “Large”, “Small”, or “Auto.
Page 63 ● Changing color Right-click on the graph area to move the pointer to “Graph color”, then select “Sensor voltage” or gas name. ”Color” window appears. Select a new color and click “OK.” Select “Reset” of Graph color to change all the colors to initial setting. *The above color change will be applied to the software completely.
Page 64 ● Changing concentration unit Right-click on the graph area to move the pointer to “Unit”, then select either “ppb” or “ng/10mL.” The concentration unit in the measurement result is changed. ● Displaying other measurement data Other measurement data of the same ID can be displayed without returning to the “Measurement history”...
Page 65 ● Displaying measurement history window Click “History” to display measurement history window. *See page 46, “Viewing measurement history” for measurement history window. ● Displaying judgment window Click “Judgment” to display the judgment window. *See page 68, “Judgment window” for details.
Page 66 ■ Creating image file and printing of measurement data The displayed window can be printed or saved as image file. ● Printing Click “Print” or right-click “Print” then select “Print” to show “Print” window. Click ”Print” after selecting printer and setting paper size, etc. *Selecting printer and setting paper size are stored and will be effective for the next printing automatically.
Page 67 ● Creating image file Right-click “Print” and select “Save as image file.” Enter the file name, select file type (jpg or bmp) and then click “Save.”...
Page 68 ■ Starting measurement You can start measurement from this window. ● Starting measurement Click “Measurement” in “Measurement data” window. *The measurement waiting window or measuring window, if any, is displayed on the current window. The current graph disappears and OralChroma status is displayed at upper right in the window.
Page 69 ● Selecting subject The subject can be re-selected on the measurement data window. Click “Select.” Enter the subject ID and click “Select,” or click “Browsing list…” and select the ID.
Page 70 ● Changing subject personal information You can change the registered personal information of the subjects. Click “Change ID information.” Change the personal information in “ID information change” window, then click “Change.” Personal information on “Measurement history” and “Measurement data” windows are updated.
Page 71: Judgment Window
Judgment window Measurement values and halitosis cognitive threshold are compared and the judgment of the functional halitosis level is displayed. For chromatogram view mode Personal information of the subject Measured gas concentration Data of the last measurement,[Name of gas: Measurement value (Judgment)] Judgment of functional halitosis level (Green background blinks) For simple view mode...
Page 72 ■ Displaying the Judgment window Either of the following procedures opens the Judgment window. ● From the Measurement data window ・ When measurement is completed, the judgment window is automatically displayed. If “No judgment is displayed after measurement” is checked on “Judgment” tab of the “System setting”...
Page 73 ■ Method of Judgment Measurement values of the three gases are compared with 'Cognitive thresholds'. If the value is above the threshold, ‘+’ is given. If it is below the threshold, ‘-' is given. 'Cognitive threshold' is the lowest level of concentration where people can identify what kind of smell it is.
Page 74 ■ Creating image file and printing of judgment window The displayed window can be printed or saved as image file. ● Printing Click “Print” or right-click “Print” then select “Print” to show “Print” window. Click ”Print” after selecting printer and setting paper size, etc. *Selecting printer and setting paper size are stored and will be effective for the next printing automatically.
Page 75: System Settings Window
System settings window You can set various items for the software. ■ Displaying System settings window Click “System settings…” on the Main window. *While System settings window is being displayed, you cannot operate other windows.
Page 76 ■ General ● Data folder Click “Browse” to change the folder where the measured data is stored. See page 21 for details.
Page 77 ● Importing data You can import the data from other computer to the current data folder. This is useful when you replace the PC. Click “Import data…” ”Data import” window appears. Select either “CHM-1” or “CHM-2.”...
Page 78 Specify the folder by clicking “Browse….” IDs in the specified folder are listed as below. Check what you want to import. Clicking “Select all” checks all the IDs at a time. Click “Import” to start importing data. Confirmation window “Data import” window appears.
Page 79 ● Exporting data You can export the current data folder when you want to back up the data or use another Click “Export data folder.” Specify the folder to which the current data folder should be copied, then click “OK.” *In case the old data folder exists in the above specified folder, it is overwritten with the exported new data folder.
Page 80 ● Model Select “CHM-1” only when you use the old model of CHM-1. ● Language You can change the language. Select the language in the drop-down list.
Page 81 ● COM port Specify the communication port to which the OralChroma is connected. See page 19 for details. ■ Print 1) Facility name, etc. You can input your own clinic logo, information or message to display and print on the user information column.
Page 82 ■ Judgment Cognitive threshold(ppb) Specify a threshold, a criterion for judgment for each gas. （See page 25） 2) Judgment comments Edit the judgment comments. （See page 26） 3) No judgment is displayed after measurement By checking this, the judgment window is not automatically displayed after the measurement. 4) Max of Y-axis(ppb) Specify the maximum value to be displayed on the Judgment window for simple view mode.
Page 83 ■ Saving the change Click “OK” on the “System setting” window to save the changes.
Page 84: Maintenance
Maintenance ■ Monitoring internal parameters Click “Internal parameters” on the Main window to display the “Internal parameters” window. This window shows some operating parameters in the OralChroma. Usually, it is not necessary for customers to use this window. ■ Error indication When an error occurs, it is indicated at “Current status”...
Page 85 ■ Daily maintenance To clean the surface of the OralChroma, wipe gently with a soft cloth. If the dirt is thick, wipe with a cloth moistened with water or mild detergent and squeeze it. Do not use detergent that contains benzene, alcohol, thinner, etc. ■...
Page 86: Troubleshooting
Troubleshooting Trouble Cause Measure Connect a power cord to the Power cord is not connected. unit, then to a receptacle. Turn on the Main switch （｜） at Main switch is not turned on Power is not the back of the unit. supplied.
Page 87: Services
Services When you suspect a failure, first check the time the failure occurred, the processes involved, and the symptoms when the failure occurred before you request repair services. After that, contact the sales agent from whom you purchased the product. Repack the product in the original package and include a detailed explanation of the error.
Page 88: Specifications
Specifications Product Product name OralChroma Model CHM-2 Detection Principle Gas chromatograph using semiconductor gas sensor Detector Highly sensitive semiconductor gas sensor Carrier gas Clean ambient air (sucked by built-in pump and purified by built-in filter) Detection gas Hydrogen sulfide, methyl mercaptan and dimethyl sulfide in oral breath samples Concentration 50 to 1000ppb...
Page 89 Nissha FIS, Inc. 2-4-28 Tagawa, Yodogawa-ku, Osaka 532-0027, Japan Tel: +81 6 7176 3911 Fax: +81 6 7176 3912 Sales agent: E181001...