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Immunofluorometer Equipment

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Presentation on theme: "Immunofluorometer Equipment"— Presentation transcript:

1 Immunofluorometer Equipment
TM i-CHROMA Reader Operation Manual

2 TABLE OF CONTENTS English
Quick Manuals E.1 II Introduction and Principle of Operation E.2 III Contents of System E.3 IV Specifications E.4 V Initial Installation Procedure E.5 VI Printer Installation E.6 VII Operation E.7 VIII Warnings, Precautions, and Limitations E.8 IX Service, Maintenance, and Disposal E.9 X Trouble Shooting E.10 XI Contact Information E.11

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

4 II Section II Introduction and Principle of Operation Introduction
This manual contains the introductions for the operation of i-CHROMATM Reader and for the sample testing procedures. Refer to the test procedure of specific product for specific test and operating instructions. i-CHROMATM 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-CHROMATM Reader can be used in a central laboratory or in a point-of-care testing facility. i-CHROMATM 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-CHROMATM Reader can accept Test Devices that are designed specifically for use with this instrument. Rev E.2.1

5 Introduction II i-CHROMATM 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-CHROMATM 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. Rev E.2.2

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

7 IV Section IV Specifications Physical Description Specifications
Dimensions (L) x 185 (W) x 80 (H) mm Weight kg Power supply V AC, 50/60Hz,  A   Data output: On-board screen / Printer Environmental Set-up Temperature 15oC ~30oC Humidity ~ 80% Location Dry, clean, flat, horizontal surface away from direct sunlight and mechanical vibration. Optical Description Light source Laser diode, 2.5 mW, 637nm Detector Silicon photo diode Other Driver Motor 12V Interface RS-232 serial (I/O) port Printer Thermal Display LCD (16x4 character) Key pad  5 function keys *** This device meets the EMI guideline as per EN Rev E.4

8 V Section V Initial Installation Procedure Installation
Reader V Power requirements i-CHROMATM 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-CHROMATM 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-CHROMATM 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. Place i-CHROMATM Reader on a flat table (surface), with the front surface at least 10cm inside of the table edge. Connect the power cord for i-CHROMATM Reader to the wall power outlet. Connect the power connector to i-CHROMATM Reader. Rev E.5.1

9 V Turn on the power switch on the left side of i-CHROMATM Reader.
Installation Reader V Turn on the power switch on the left side of i-CHROMATM Reader. i-CHROMATM 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.) M E N U D 13:13:00 * Test Mode Setting Mode i-CHROMATM Reader is now ready for use. At the end of the run, remove the Test Device from i-CHROMATM Reader. Also, make sure the sample holder is retracted before turning the power off. Caution: Keep the cables, cords and wirings for the power adapter and the printer away the front and the top surface of i-CHROMATM Reader. These could render it hazardous to connect/disconnect the power adapter (and the printer). Rev E.5.2

10 VI Section VI Printer Installation
i-CHROMATM 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-CHROMATM Reader following steps listed below. 1. Connect the other of the cable to i-CHROMATM Reader. 2. Now the printer is ready for operation. 3. Turn on the power switch on the left side of Printer. Rev E.6

11 Section VII Operation VII Function Keys
The operation of i-CHROMATM 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-CHROMATM 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. Operation VII Function Keys The “cursor” in these descriptions stands for the “>>” notation. This function moves the cursor down a line on the display window. Down Up This function moves the cursor up a line on the display window. This function returns the screen to the previous mode. Reset This function selects and executes the command at the cursor position Select In/Out This function moves the sample carrier in and out of the main body of i-CHROMATM 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. Rev E.7.1

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

13 VII 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 Operation VII i-CHROMATM Reader will scan the System Control Device automatically. System Check Reading Progressing 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 to “MENU” mode. Now you can run another test. System Check System OK Rev E.7.3 13

14 Procedure for Test Mode
The following steps describe recommended procedures for a test in i-CHROMATM 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. Operation VII On-Screen displays and applicable steps When you turn power switch on, you will see ”MENU” on–Screen after “Self Test Mode”. M E N U D 13:13:00 * Test Mode Setting Mode Choose “Test mode” by moving cursor with “Up” or “Down” key. Press “Select” key to move next stage after you chose a specific mode. Insert ID Chip “Insert ID Chip” is displayed on the screen. Insert a proper ID chip which you want to test. Rev E.7.4

15 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 Operation VII hsCRP Test Reaction Progressing 05 : 00 i-CHROMATM Reader will scan the Test Device automatically after 3 min for immune reaction. hsCRP Test Reading Progressing OO % 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 to “MENU” mode. Now you can run another test. hsCRP Test O.O mg/L Rev E.7.5

16 Procedure for Time Setting and Recall Previous Results
Operation VII MENU D 13:13:00 Test Mode * Setting Mode Choose “Setting Mode” and “Time Set” or “Recall Result” by moving cursor with “Up” or “Down” key. Press “Select” key to move next stage after you chose a specific mode. MENU D 13:13:00 Recall Result * Time Set “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. MENU * SELECT SET * RESET year. month. day hour : min 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. “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. hsCRP Test 01 00.0 mg/L year. month. day 13:13 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 E.7.6

17 The test sample should be applied to the “B” well, as shown below.
Caution in handling the cartridge Operation VII The test sample should be applied to the “B” well, as shown below. A B When inserting the Test Device into the holder, orient the Test Device in such a way that the “B” well should be toward i-CHROMATM Reader. This direction is also marked with an arrow on the Test Device . A B 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. Don’t 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. Rev E.7.7

18 Warnings, Precautions and Limitations
Section VIII Warnings, Precautions and Limitations Do not insert anything other than a Test Device provided by the manufacturer into the sample holder. Do not immerse i-CHROMATM Reader into water. Do not spill any liquid on i-CHROMATM Reader. This may disable the system. Do not drop i-CHROMATM Reader. Do not subject i-CHROMA to mechanical shocks heavier than light taps with hands. Do not open i-CHROMATM Reader without written authorization from its representative. Do not place heavy objects on i-CHROMATM Reader. This may damage the optical alignment to result in degraded performance or in mechanical damage. Use only the power adapter provided with i-CHROMATM Reader. Use i-CHROMATM 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. Limitations Precautions Warnings VIII Cautions should be taken to use i-CHROMATM 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-CHROMATM Reader may be compromised to present severe electrical, mechanical or biological hazards to the user. Rev E.8

19 Section X Trouble Shooting X Call customer service.
Internal Electrical or Mechanical Fault Message: “Error 21~24” User’s action is not required. Normal mechanical setting Clicking noise when the holder extends Electric circuit failure Ground the surface of i-CHROMATM 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 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. Faulty power adapter Turn on the main switch. Main switch is off. Remove the power cable (from SMPS to i-CHROMATM 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 Measures Probable Causes Symptoms Symptoms users can take corrective measures Shooting Trouble X Rev E.10.1

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


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