4.2.9 Cubic Spline Mode........................28 4.2.10 Cutoff Mode ..........................29 5. CHROMATE MANAGER ........................31 5.1 O ......................31 PENING ANAGER 5.1.1 ChroMate Manager Toolbar Icons....................31 5.2 M & F ....................32 ELECTIONS EATURES 5.2.1 Management Menu ........................32 5.2.2 Tests Menu...........................
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..........................76 RROR ESSAGES 6.2 COM P ......................... 78 ETTINGS 6.2.1 PC Communication (COM) Port Setting ..................78 6.2.2 ChroMate Communication (COM) Port Setting................80 7. CONTACT INFORMATION ....................... 83 8. APPENDIX ............................. 84 8.1 L (LIS) ..................84 ABORATORY NFORMATION...
1. INTRODUCTION 1.1 Applications 1.1.1 Intended Use The ChroMate™ 4300 is a laboratory instrument intended for in-vitro diagnostic use. It is a user-programmable open system with selectable plate formatting, alphanumeric test naming, automatic interpretation options, duplicate well options, curve plotting and editing, and flags and error messages.
User-programmable Memory ChroMate software allows the operator to create, edit and store assays. Standard curves are also stored in this memory. Test protocols remain stored until either changed or deleted by the user. 1.1.3 Principles of Operation The plate carrier precisely positions each well into the optical path for reading.
WARNING indicates an injury hazard not immediately accessible as you read this marking AVERTISSEMENT! Le “de indique qu’un risque de dommages qui marque: WARNING” n’est pas immédiat alors vous lisent cette marque ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Refer any questions to your instrument service provider. • Servicing There are no user-serviceable parts inside the instrument. Refer servicing to qualified service personnel. Use only factory-authorized parts. Failure to do so may void the warranty. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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• Observe All Terminal Ratings To avoid fire or shock hazard, observe all ratings and markings on the instrument. Consult this manual for further ratings information before making connections to the instrument. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Use as a disinfectant a 10% solution of chlorine bleach (5.25% Sodium Hypochlorite) or 70% isopropyl alcohol. Take special care not to spill liquid inside the instrument. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Avertissement! Lors du fonctionnement, si on renverse des matériaux, coupez immédiatement le courant. Placez le commutateur électrique a AU LOIN(0). Traitez le matériel comme biohazardous, utilisant approprie nettoient et des méthodes de disposition. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
All power cords must be approved for the country of use PC Connection: USB Port Microprocessor: eZ80 Speed: Reads absorbance of 96 wells in approximately 8 seconds Plate Transport: Stepper motor Certifications: Pending ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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• Software: PC interface with ChroMate™ Manager software – included (PC not included) Features: PC interface software (included) with complete user prompting, error messages, full plate reporting, automatic interpretation options, duplicate options, controls locator, curve plotting and editing Format: CD-ROM and internet upgrades ®...
For 220-240 V units used inside the US use a UL listed cord as above, except rated 250 V, with a tandem blade, grounding type attachment plug. The cord set provided by the manufacturer meets these requirements. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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Avertissement! Pour la protection continue contre le risque FUSIBLE du feu, remplacez le fusible seulement par une du type spécifique et des estimations courantes. Démontez l’équipement de l’alimentation d’énergie avant de remplacer le fusible. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Section 4-Operating Procedures. 3.2.1 Parts of the Instrument A) Door B) Indicator light Figure 3.2.1-1 Front of Instrument A) Tray out (extended) B) Door open Figure 3.2.1-2 Door open, tray out ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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Figure 3.2.1-3 Door open, tray extended loaded with a microplate D) External A) Power switch Protective Grounding B) Lamp access Terminal door C) Universal E) Power Cord Serial Bus Connection (USB) connection Figure 3.2.1-4 Back of Instrument ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
IMPORTANT NOTE: AS WITH MANY USB DEVICES IT IS CRITICAL THAT YOU DO NOT CONNECT THE USB CABLE TO THE CHROMATE OR COMPUTER UNTIL THE SOFTWARE HAS BEEN INSTALLED. DOING SO MAY AFFECT THE INSTALLATION OF THE APPLICABLE DRIVERS NEEDED TO RUN CHROMATE MANAGER.
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Prompts/Screen Display Setup process begins: Figure 3.3.1-2 Welcome to ChroMate Setup Figure 3.3.1-3 Destination Folder Figure 3.3.1-4 Program Folder Figure 3.3.1-5 Installation Progress Indicator Click Finish to complete Setup. ChroMate Manager Icon ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Steps Prompts/Screen Display Install the virtual com port (VCP) drivers from the file located in the folder C:\Chromate\USB drivers (or “[Installation Folder]\USB drivers if you changed the install directory name). From the USB Drivers folder click on the appropriate executable (.exe) file for the operating system on your computer (i.e., XP, Vista, Windows98):...
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Click on the “Launch the VCP Driver Installer” check box and click on the Finish button to execute the driver installation process. Installation successful, click on OK Installation complete, click on Finish button ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Manager. However, instructions on how to view and adjust the setting are provided in Section 6.2.1 PC Communication (COM) Port Setting. The 4300 ChroMate COM port setting does not require an adjustment to match the computer’s COM Port setting. However, steps have been provided in Section 6.2.2 ChroMate Communication (COM) Port Setting to view/adjust the setting if necessary.
3.4 Instrument Check Out Follow the instructions under the Instrument Setup & Software Installation section to ensure that the ChroMate Manager software is installed and the computer and the 4300 Chromate instrument are powered on. NOTE: If it is necessary to view / adjust the communication port settings of the computer and the ChroMate instrument refer to the instructions found under Section 6.2 - COM...
10. Will a cutoff value be used to label negative samples or define an equivocal zone? If so, results less than what cutoff should be labeled as negative? ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
(12 well strips) beginning at well A-1. It may be necessary to switch formats in order to perform assays from different manufacturers. ChroMate software can be configured for reading and presenting data using either format. Selecting a Plate Format:...
4.2 Assay Modes The ChroMate software contains several pre-programmed general-purpose calculations selected to facilitate data handling for enzyme immunoassays and other similar tests. Access the Assay Modes via ChroMate Manager Tests Menu (refer to Section 5.2.2) Absorbance Factor Standard % Absorbance...
The instrument first accepts a calibrator read singly or in multiple numbers and then calculates concentrations based on a single- point standard curve passing through the point (0,0). A blank is required to determine the (0,0) point. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
It then calculates concentrations based on the point-to-point calibration curve. Data may be entered for linear-linear, ln ( = natural log)-linear, linear-ln, or ln-ln calculations. Blanking, graphing, and editing options are available. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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7. “Y=Abs, X=Log(Conc)” - absorbance is plotted against the base-10 log of the concentration. 8. “Y=Log(1000*ABS), X=Log(Conc)” -- the base-10 log of the absorbance is plotted against the base-10 log of the concentration. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Y = A + B * X + C * X^2 + D * X ^3 Forth order is defined by: Y = A + B * X + C * X^2 + D * X ^3 + E * X ^4 Graphing and editing options are available. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Blanking, graphing and editing options are available. Absorbance, or ln of (1000 * absorbance), is always on the “Y” axis, and concentration, or ln of concentration, is always on the “X” axis. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
The resulting calibrator curve is a smooth curve connecting the calibrator points, which may be entered in ascending or descending order of absorbance. A constraining algorithm is applied to prevent curve overshoot. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Samples with values lower than the cut off are labeled as “positive”. If you choose this option, be careful to follow the < and > signs in the prompts for entering cut offs and ranges. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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(positive <= cutoff, negative > cutoff). The instrument calculates the mean of the positives and the mean of the negatives. User programmable QC Criteria is available on all controls. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
ChroMate™ uses the standard Windows ® controls, windows, and dialogs. Refer to your Windows ® documentation to become familiar with these controls and how to use them. Ensure that the 4300 ChroMate instrument is connected via USB cable to the computer (see Section 3.3 Instrument Setup & Software Installation).
Figure 5.2-1 ChroMate Manager Menu Bar 5.2.1 Management Menu When ChroMate is finished reading, the New Assay Calibration Data can be viewed by selecting this option from the Management drop down menu or by pressing the F8 key on your keyboard at any time. This window shows whether the new curves and controls were accepted.
Refer to Section 5.2.2.1 Read Plate Absorbance for Read Plate more information. Absorbance Refer to the Create Assay section that follows for more Create Assay information. Refer to the Edit Assay section that follows for more Edit Assay information. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Click on the check box if Blanks are used. Use Blanks Click on the Read Plate button to activate. Read Plate Click on the Export button to send the absorbance Export readings to Notepad, creating a .txt file: ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
5.2.2.2 Create Assay Create Assay accessed via the Tests Menu selection on the ChroMate Manager’s Menu Bar: OPTIONS DESCRIPTION Enter the name of the assay Assay Name Select the Primary Filter and the Differential Filter Wavelengths Select an Assay Mode for the drop down window...
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Select Controls: The controls will be accepted even if they read out of range if the Control Properties are set to “Warn and Continue”. To check your Control Properties or change this setting, see the Assay Calibration Tab. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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7 days. After they expire, you will have to re-run the Calibrators to use that assay. You may run more frequent recalibrations and control checks as often as you like. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.2.2.3 Edit Assay Edit Assay is accessed via the Tests Menu selection on the ChroMate Manager’s Menu Bar: Select the Assay from the drop down menu. Dialog window will open with options based on the assay type. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Identify the Substance in the left column to be registered by clicking on the substance title. Click “Register” Enter the lot number and a description (optional). Click OK to Save. Figure 5.2.3-2 Enter Lot # and optional description ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.2.4 QC Tracking Menu QC Tracking enables Controls and Calibrators to be tracked using a Levy-Jennings chart. Figure 5.2.4-1 QC Tracking Menu Page Figure 5.2.4-2 QC Tracking Example ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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Lot # Registration. Edit by selecting the Select QC Points button or by un-checking the checkbox for specific QC points. Select the Save QC Points button to save the QC points displayed. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.2.5 Sample Database Select Sample DB from the ChroMate Manager Menu Bar: When first opened, the Sample Database window will not have any records to display: 5.2.5.1 Add to Sample Database Select the Edit button to enter Sample ID, Family Name, Given Name, etc. This will be helpful as search criteria when searching the database.
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Delete key on the keyboard. Additional criterion includes Custom1 or Custom2. Information that can be useful in either Custom1 or Custom2 can include, but is not limited to, medical issuer, study ID numbers, or chronic diagnosis. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
NOTE: The user must be in EDIT mode to be able to delete. A dialog box will open prompting the user to confirm the deletion of the record. Press Yes to delete, press No to cancel the deletion process. Press the Close button to close the Sample DB window. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Select the View Log button to view the Patient.DB.log in Notepad. Figure 5.2.5.4-1 View Log button The log will display the modification date, time and the change that was made: Figure 5.2.5.4-2 Modified date and time ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.2.5.5 Import Patient Record Import Patient Record 1) Click to highlight the Sample ID to import. Select the Import button to migrate the selected record to a text file in Notepad. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
2) Click on File and select Save. Close the window when finished. 5.2.5.7 Search Patient Record Search Patient Record 1) Enter criteria into Search Database area, press OK. All records containing the specified criteria will display. Search result displayed ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.2.5.8 Choose Patient Record Choose Patient Record 1) Select the Choose button to add a selected patient to the Sample ID list in the Sample tab. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
5.2.6.1 Comm Port, Database, Report Settings OPTION DESCRIPTION Refer to the steps in Section 6.2 COM Port Settings to Comm Port, Database, view / adjust the COM Port Setting of the computer and Report…: the 4300 ChroMate. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
ID records will be retained for a specified amount of time; and adjust the COM Port setting to match the COM Port setting of the computer. Refer to Sections 6.2 COM Port Settings ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Sample Database sample database. Click on the checkbox to uncheck the selection; only selections that are checked boxes will be applied. Click the OK button once all the selections have been made. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Report Appearance allows the user to specify their preferences such as margins, page orientation, logo, font etc. NOTE: Refer to Figure A for a logo example and report sample. Figure A - Logo Example and Report ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
5.2.6.1.1.4 Report Output OPTION DESCRIPTION Report Output allows the user to specify data to print for Report Output different report types. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Report template. Preview calibration reports via the Calibration Tab and preview button; preview sample reports via the Report Tab and preview button. Modify the example Custom Report and save it to a new file name. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Manager and restart the software to initialize the selected language. The selected language will remain in effect until another language is selected and the software is restarted as in the step above. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
5.2.7 Maintenance The Maintenance option allows the user to update the firmware via the ChroMate Firmware Update selection; and lock / unlock calibration via the ChroMate Calibration Lock/Unlock option. 5.2.7.1 Firmware Update The Firmware Update option allows the user to update to a new firmware version.
5.2.7.2 ChroMate Calibration Lock/Unlock The calibration settings for the 4300 ChroMate are set by the factory. The ChroMate Calibration Lock/Unlock feature is locked at the factory as well. This feature is for emergency use only by authorized personnel in case the device would need to be recalibrated.
5.3 ChroMate Manager Tabs The ChroMate Manager Tabs are located at the bottom of the screen: Tab Title: Description: Item No.: Plate Layout Tab Plate Layout is ChroMate’s default window. Refer to Section 5.3.1. Assay Refer to Section 5.3.2 Calibration Tab Add Samples Tab Refer to Section 5.3.3...
5.3.1 Plate Layout Tab Plate Layout is the ChroMate’s default window and displays when the program is started. Figure 5.3.1-1 Plate Layout Tab This window displays the current status of the instrument. Also shown is the currently loaded plate. Feature: Description: Item No.:...
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Plate Layout Tab (Continued) Feature: Description: Item No.: Reset Clears the layout. Re-Assign Provides the ability to change location of the wells on the plate. Remove Removes well assignments. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
5.3.2 Assay Calibration Tab When ChroMate is finished reading, the New Assay Calibration Data can be viewed by selecting this option from the Management drop down menu or by pressing the F8 key on your keyboard at any time. This window shows whether the new curves and controls were accepted.
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Print Preview calibration and control results before Preview printing statistics such as %CV, %Dif, and mean values are also shown. Print Report Allows the user to print the selected assay. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Controls will be added to the Work List. You may run more than one of each of the calibrators. Change the repetition numbers by using menu options (2). Figure 5.3.2-2 Worklist displayed ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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Click on the Accept button to accept results. Accepting calibrators moves them from the ChroMate Manager Test Results Tab to the Assay Calibration Tab. Once the calibrators have been moved into the Assay Calibration Tab they need to be accepted.
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Test Results Tab to the Report Tab where they are automatically stored in the ChroMate database and may be printed in reports. In Figure 5.3.2-3, a TSH standard curve is displayed. This assay uses a 2 order polynomial curve fit.
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Even though the samples show decreased absorbance values similar to the one adjustment standard run, the resulting concentration values for the samples are the same as when they were run with the original complete standard curve. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Item No.: Enter Press the ‘Add Sample ID’ to choose a patient Sample IDs from the Sample Database (refer to Section 5.2.5). Press the ‘Add Numerical ID’ button to enter samples by number. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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If the Add to Plate button has been selected, the screen will be directed to Plate Layout where you will have several options: Load Plate, Save Plate, Reset, Re- Assign, Read Plate or Remove. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Click Remove or Add to Plate tabs. After Assay Calibration and Add Samples you will again be directed to Plate Layout screen. Verify position, Name/ID, and Assay with well assignment. Click on tab for desired option. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
A list of all of the assays will display. The Current Step that is running displays to the right of the drop down menus. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Press ‘Delete’ to discard the selected ID. NOTE: Results must be accepted to allow them to be viewed in the Report Tab. Legend Used to identify the processes and results used Used by by the software. Software ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Select the History checkbox to begin searching Checkbox for results by date, Name/ID or test name. Sorting Select the Sorting Option from the drop down Option menu to change the way the results are displayed. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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Note: If needed, an Assay Report or a Calibration Report may be printed from the Calibration window. See the Section Assay Calibration Tab for more information. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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Adds the selected items to the Sample Tab to be to Sample re-tested. Tab) Export Exports selected results to a text file (*.txt), MS Excel file (*.xls), or XML file (*.xml). Save for future reference. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
Channel number must be in valid range (1-8) (1-8) 012 Invalid Serial ID Serial ID must be number (1-99999) 013 Invalid Lamp Timeout Lamp Timeout value bad (120-1800) 014 Invalid Lamp Warm Lamp Warm time bad (0-60) Time %d ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
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302 Pot %d, wiper %d – not Contact Customer Service 303 Pot %d, wiper %d – not Contact Customer Service 401 Lamp voltage low, Contact Customer Service ch(%d) Filt %d(%s) <%1.3f volts ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
6.2 COM Port Settings Generally the communication (COM) port setting of the PC and the 4300 ChroMate will not require adjustment. However, the following steps are included just in case the user needs to view the setting or make an adjustment to the setting.
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System The System Properties window will open; click on the Hardware tab Click on the Device Manager button From the Device Manager window, double click on the Ports (COM & LPT) folder. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
COM port is COM3, your system may display a different port. 6.2.2 ChroMate Communication (COM) Port Setting To adjust the 4300 ChroMate COM Port Setting to match the computer’s COM Port setting, follow these steps: Steps Prompts/Screen Display Power on the 4300 The computer screen will display the ChroMate logo: ChroMate instrument.
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Plate Layout Display Click on the Settings tab on the ChroMate Manager Menu Bar to access the Comm Port setting: Click on the “Comm Port, Database, Report…” option on the Settings drop down menu: ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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(COM) Port Setting). Click to highlight the setting and then click on the OK button to save the setting. NOTE: The COM port setting will remain at this setting until it is changed. ChroMate™ Operator’s Manual Doc. 4300 Rev. E...
Important: When contacting us, please have the Model and Serial Number of the ChroMate™ in question. Have a description of the problem with as much detail as possible. Save any relevant jobs or logs and send or e-mail us the information.
8. APPENDIX 8.1 Laboratory Information System (LIS) The ChroMate™ Laboratory Information System (LIS) provides a method, or protocol, to allow for ease of information exchange between two systems. patient information from external sources can be easily uploaded into our patient database.
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Sequence Number| Count | Line Count | Batch Number NOTE: A solid bar (|) indicates the field is for future use. The bar delimiter is necessary for correct formatting within the record. ChroMate™ Operator’s Manual Doc. 4300 Rev. E ChroMate™...
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