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I-CHROMA TM Immunofluorometer Equipment Reader Operation Manual.

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Presentation on theme: "I-CHROMA TM Immunofluorometer Equipment Reader Operation Manual."— Presentation transcript:

1 i-CHROMA TM Immunofluorometer Equipment Reader Operation Manual

2 IQuick ManualsE.1 IIIntroduction and Principle of OperationE.2 IIIContents of SystemE.3 IVSpecificationsE.4 VInitial Installation ProcedureE.5 VIPrinter InstallationE.6 VIIOperationE.7 VIIIWarnings, Precautions, and LimitationsE.8 IXService, Maintenance, and DisposalE.9 XTrouble ShootingE.10 XIContact InformationE.11 English TABLE OF CONTENTS

3 Section I Quick Manual I Rev. 10 E.1 For finish a test, press In/Out button to put the holder back Power Switch OFF Quick Manual for TEST MODE I II III IV

4 This manual contains the introductions for the operation of i-CHROMA TM Reader and for the sample testing procedures. Refer to the test procedure of specific product for specific test and operating instructions. i-CHROMA TM Reader, manufactured by BodiTech Med Inc., is a portable instrument for fluorescence detection to quantify concentration of various kind of analytes in blood or urine. The assays and the instrument are for in-vitro diagnostic use only. i-CHROMA TM Reader can be used in a central laboratory or in a point-of-care testing facility. i-CHROMA TM Reader uses a laser as the excitation light source. The emitted light from the fluorescence dye is collected and converted into an electrical signal. The signal is closely related to the amount of fluorescing dye molecules present on the spot under examination. After a buffer-mixed sample is applied to the Test Device, the Test Device is inserted into i-CHROMA Reader and the concentration of analyte is calculated by a pre-programmed calibration process. i-CHROMA TM Reader can accept Test Devices that are designed specifically for use with this instrument. Section II Introduction and Principle of Operation Introduction II Rev. 10 E.2.1

5 i-CHROMA TM Reader is equipped with a built-in Test Device holder and does not require an external holder to place the Test Device in. The Test Device holder will appear through the opening on the front surface of the Reader. The main power switch, located on the left side of the instrument, powers the i-CHROMA TM Reader. The optional printer comes with its own power supply. These two power supplies have different power ratings, and a critical damage on instrument can thus be resulted in if power supplies are connected incorrectly. Power supplies are labeled, indicating that which unit are supposed to work with. Introduction II Rev. 10 E.2.2

6 Section III Contents of System Unpacking After opening the box, compare the contents with the list below. Contents i-CHROMA TM Reader set i-CHROMA TM Reader1 Operation manual1 Power cable for Reader1 Connection cable1 Printer set (Optional) Thermal printer1 Manual for printer1 Printer paper (roll)1 Pipette set (Optional) Pipette (10, 20, 30, 75, 100ul)1 Capillary tube (5ul)1 System Check Chip set Cartridge 1 ID chip 1 Contents III Rev. 10 E.3

7 Physical Description Dimensions 250 (L) x 185 (W) x 80 (H) mm Weight 2 kg Power supply V AC, 50/60Hz, A Data output: On-board screen / Printer Environmental Set-up Temperature15 o C ~30 o C Humidity 10 ~ 80% Location Dry, clean, flat, horizontal surface away from direct sunlight and mechanical vibration. Optical Description Light sourceLaser diode, 2.5 mW, 637nm Detector Silicon photo diode Other Driver Motor12V InterfaceRS-232 serial (I/O) port PrinterThermal DisplayLCD (16x4 character) Key pad 5 function keys *** This device meets the EMI guideline as per EN Section IV Specifications IV Rev. 10 E.4

8 Section V Initial Installation Procedure Power requirements i-CHROMA TM Reader will work on household power line, V or V AC, 50 ~ 60Hz. If you are uncertain of your power line, consult with your utility manager. Location i-CHROMA TM Reader should be placed on a dry, clean, flat, and horizontal surface away from direct sunlight and other source of electromagnetic radiation (power transformers for example). To set-up i-CHROMA TM Reader for the first time, remove the contents from the packing materials. Inspect the contents for any physical damages and any missing components compared to the suggested list of contents. 1.Place i-CHROMA TM Reader on a flat table (surface), with the front surface at least 10cm inside of the table edge. Connect the power cord for i-CHROMA TM Reader to the wall power outlet. Connect the power connector to i-CHROMA TM Reader. Reader Installation V Rev. 10 E.5.1

9 4.Turn on the power switch on the left side of i-CHROMA TM Reader. 5.i-CHROMA TM Reader will execute a series of self-checking routine. Upon successful completion, the display monitor will show the initial screen as shown below. (The actual contents of the display could be differ, depending on the specification and customer requirements.) Caution: Keep the cables, cords and wirings for the power adapter and the printer away the front and the top surface of i-CHROMA TM Reader. These could render it hazardous to connect/disconnect the power adapter (and the printer). 6.i-CHROMA TM Reader is now ready for use. 7.At the end of the run, remove the Test Device from i-CHROMA TM Reader. Also, make sure the sample holder is retracted before turning the power off. M E N U 22D 13:13:00 * Test Mode Setting Mode Reader Installation V Rev. 10 E.5.2

10 Section VI Printer Installation i-CHROMA TM Reader comes with an optional printer that preconfigured to work. For proper handling and installation of the printer, refer to the instruction manual accompanying the printer. With the printer ready for operation, you can connect the printer to i-CHROMA TM Reader following steps listed below. 1. Connect the other of the cable to i-CHROMA TM Reader. 2. Now the printer is ready for operation. 3. Turn on the power switch on the left side of Printer. Printer Installation VI Rev. 10 E.6

11 Section VII Operation The operation of i-CHROMA TM Reader is performed by five primary functions each of which can be represented by corresponding key pad on the front panel. The software in i-CHROMA TM Reader is designed concisely and user-friendly to be used in a point-of-care or a central laboratory setting. Each of these functions is addressed in this section. Function Keys The cursor in these descriptions stands for the >> notation. This function selects and executes the command at the cursor position This function moves the sample carrier in and out of the main body of i-CHROMA TM Reader. This key is also used to finish the run: the sample holder stays extended at the end of the run and this key retracts the holder back into the main body. This function returns the screen to the previous mode. This function moves the cursor up a line on the display window. This function moves the cursor down a line on the display window. Operation VII Rev. 10 E.7.1 Down Up Reset Select In/Out

12 Procedure for System Check The following steps describe recommended procedures for a test in i-CH ROMA TM Reader with a System Control Device. On-Screen displays and applicable steps When you turn power switch on, you will see MENU on–Screen after Self Test Mode. Insert ID Chip Choose Test mode by moving cursor withUp or Down key. Press Select key to move next stage after you chose a specific mode. Insert ID Chip is displayed on the screen. Insert a System Check ID chip. Operation VII M E N U 22D 13:13:00 * Test Mode Setting Mode Rev. 10 E.7.2

13 System Check Reading Progressing i-CHROMA TM Reader will scan the System Control Device automatically. Prepare a System Control Device And then, you should do a test Insert a System Control Device into the holder after a sample loading. Press Select key to start. Insert Control Cartridge Select to Start System Check System OK The test result will show up on-screen. You can also get the print-out of test result. If you press Reset button, Screen will return toMENU mode. Now you can run another test. Operation VII Rev. 10 E.7.3

14 Procedure for Test Mode The following steps describe recommended procedures for a test in i-CH ROMA TM Reader with a specific Test Device. You can use only whole blood for test (No serum or commercial controls) The actual display may differ from the ones shown below, depending on the factory configuration of the Reader. If the scanning is stopped by accident or error message is displayed on the screen, you will hear an alarm sound. Please check out the cause of alarm sound. On-Screen displays and applicable steps When you turn power switch on, you will see MENU on–Screen after Self Test Mode. Insert ID Chip Choose Test mode by moving cursor withUp or Down key. Press Select key to move next stage after you chose a specific mode. Insert ID Chip is displayed on the screen. Insert a proper ID chip which you want to test. Operation VII M E N U 22D 13:13:00 * Test Mode Setting Mode Rev. 10 E.7.4

15 hsCRP Test Reading Progressing OO % i-CHROMA TM Reader will scan the Test Device automatically after 3 min for immune reaction. Prepare a Test Device and apply sample mixture onto the Test Device. And then, you should do a test Insert a Test Device into the holder after a sample loading. Press Select key to start. Insert hsCRP Cartridge Select to Start hsCRP Test O.O mg/L The test result will show up on-screen. You can also get the print-out of test result. If you press Reset button, Screen will return toMENU mode. Now you can run another test. Operation VII hsCRP Test Reaction Progressing 05 : 00 Rev. 10 E.7.5

16 MENU * SELECT SET * RESET year. month. day hour : min Time Set mode is for date/time setting only when you activate the instrument for the first time or reuse after not using the instrument more than a month. After pressing Reset key, you can set year blinking with Up or Down key. Procedure for Time Setting and Recall Previous Results Choose Setting Mode and Time Set orRecall Result by moving cursor with Up orDown key. Press Select key to move next stage after you chose a specific mode. MENU 22D 13:13:00 Recall Result * Time Set PRE * RESET NEXT * SELECT year. month. day hour : min Use Select key to move year to month to date to time while setting month/date/time with Up or Down key. Press Select key to go back to Menu mode when you finish setting date/time. Operation VII MENU 22D 13:13:00 Test Mode * Setting Mode hsCRP Test mg/L year. month. day 13:13 Recall Result mode is used to store and recall previous tests. You can store up to 100 test results and can also print the test result. You can find the test result by searching date and time of the test with Up or Down key. For printing the previous results, press Select key. Print Data * One All Choose One mode for single result or All mode for total data with Up or Down key and then press Select key. Rev. 10 E.7.6

17 The test sample should be applied to the B well, as shown below. Caution in handling the cartridge When inserting the Test Device into the holder, orient the Test Device in such a way that the B well should be toward i- CHROMA TM Reader. This direction is also marked with an arrow on the Test Device. Push the Test Device all the way into the holder until the Test Device comes to a stop. Use only the push of your thumb or the index finger. Dont use of excessive force on the Test Device, or it will result in a mechanical failure. The spent Test Device should be treated as a potential bio-hazard and should be disposed of according to the standing ordinance. We recommend high temperature autoclaving, followed by incineration. A B A B Operation VII Rev. 10 E.7.7

18 Do not insert anything other than a Test Device provided by the manufacturer into the sample holder. Do not immerse i-CHROMA TM Reader into water. Do not spill any liquid on i-CHROMA TM Reader. This may disable the system. Do not drop i-CHROMA TM Reader. Do not subject i-CHROMA to mechanical shocks heavier than light taps with hands. Do not open i-CHROMA TM Reader without written authorization from its representative. Do not place heavy objects on i-CHROMA TM Reader. This may damage the optical alignment to result in degraded performance or in mechanical damage. Use only the power adapter provided with i-CHROMA TM Reader. Use i-CHROMA TM Reader only in environment as specified in section IV. Use the test result as a pre-screening guide. The result should be interpreted by trained medical personnel only. Section VIII Warnings, Precautions and Limitations Cautions should be taken to use i-CHROMA TM Reader in settings meeting the requirements specified in Section IV of this manual and in observance of the warnings in Section VIII. If used otherwise, the built-in safety features of i-CHROMA TM Reader may be compromised to present severe electrical, mechanical or biological hazards to the user. Warnings Precautions Limitations VIII Rev. 10 E.8

19 Section X Trouble Shooting Call customer service. Internal Electrical or Mechanical Fault Message: Error 21~24 Users action is not required. Normal mechanical setting Clicking noise when the holder extends Call customer service.Electric circuit failure Ground the surface of i-CHRO MA TM Reader to electric ground terminal. Remove any source of electric charge. Reset the system. Electrostatic shock Display does not function properly. Turn off the power and start fresh Software Abnormality Call customer service. Mechanical failure (Buzzing noise) Sample holder does not show. Turn the power off and on again. Computational Abnormality Wait till the computation is finished. Excessive computational load Run finished and no result returned. Call customer service.Faulty power adapter Turn on the main switch.Main switch is off. Remove the power cable (from SMPS to i-CHROMA TM Reader) and reconnect firmly. Poor connection between the power adapter and the cable. Check if the wall outlet is alive.Power failure Nothing happens Recommended MeasuresProbable CausesSymptoms Symptoms users can take corrective measures Trouble Shooting X Rev. 10 E.10.1

20 SymptomsProbable Causes Recommended Measures Message: Error 25~28 Technical problem with the Test Device Retest using fresh sample or device. Message: Error S1 or S2 Optical failureCall customer service. Message: Value Error 1-10 Unusual sample or incorrect storage of reagents Retest using fresh sample or device. Message: Caution Error or Error Technical problem with the Test Device Replace the Test Device with a new one and repeat the test. Message: Caution Barcode Error Test Device alignment is off. Remove the Test Device and try again. Repeat with a new Test Device. Call customer service. Message: Lot Number Error Message: ID Chip Lot Number Mismatch Does not match the Test Device lot # with ID Chip # Check the Test Device lot # and ID Chip #. Message: ID Chip Cartridge Mismatch Does not match the Test Device Item with ID Chip Item Check the Test Device Item and ID Chip Item. Message: Insert ID Chip No ID Chip Insert ID Chip onto the instrument. Message: Hb Low Hb conc. of the sample is below 5.0 g/dL Retest the sample and make sure that a correct volume of detector is applied. Message: Hb High Hb conc. of the sample is above 25.0 g/dL. The volume of detector is too small Retest the sample and make sure that a correct volume of detector is applied. Trouble Shooting X Rev. 10 E.10.2


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