SD Biosensor STANDARD F2400 User Manual Download Page 1

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User Manual for STANDARD F2400 Analyzer

Manufacturing Site: 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbuk-do

+82-31-300-0400 +82-31-300-0499 [email protected] www.sdbiosensor.com

Manufacturer :

Medical Device

Summary of Contents for STANDARD F2400

Page 1: ...TANDARD F2400 Analyzer Manufacturing Site 74 Osongsaengmyeong 4 ro Osong eup Heungdeok gu Cheongju si Chungcheongbuk do 82 31 300 0400 82 31 300 0499 sales sdbiosensor com www sdbiosensor com Manufacturer Medical Device ...

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Page 3: ...quired preparations and test procedure before performing a first test Please read the instructions carefully which are included in each test device package before using the Analyzer If you have any questions about the analyzer please contact your local distributor You can also visit www sdbiosensor com for product demonstrations Again thank you for purchasing the STANDARD F2400 Analyzer ...

Page 4: ...12 Precautions before perform a test 13 Specifications 15 Appearance of STANDARD F2400 Analyzer 16 Accessories of the STANDARD F2400 Analyzer 18 Chapter 03 Log On and Setting 19 Operation of Analyzer 19 Chapter 04 Work Place 30 Performing a test Review 30 Chapter 05 Calibration 38 Calibration Set Test 38 Chapter 06 Quality Control 43 Quality Control Test 43 ...

Page 5: ...Analyzer 52 Maintenance Transportation 52 Chapter 08 Messages Troubleshooting 53 Warning Messages 53 Error Messages 54 ANNEX 01 Information for Professional Medical Personnel 57 Protection from Infection 57 Electromagnetic compatibility 57 Disposal 57 ...

Page 6: ...ation Insert Device CAL 1 Device Checking Device Checking Device Checking Insert Device CAL 2 Insert Device CAL 3 Analyzing Result Calibration Review Prepare CAL Device Log On QC Run QC QC Res Revi Input Control ID Insert Device Apply Sample Mounting Device Checking Sample Checking QC with Control solution Insert Device Device Checking Apply Sample Mounting Select Control Information Sample Checki...

Page 7: ...enance Statistics Operator Network Date Time Brightness Volume Print Language Update Add Edit Delete Network HIS LIS Monthly review QC QC Result Review ert vice vice cking ply mple nting ect ntrol mation mple cking ernal QC ...

Page 8: ...acture To indicate the date of manufacture Serial Number Note To indicates that the analyzer is fragile and you need to handle it with care Batch code Indicate the lot number of the system Crossed out wheeled bin Discard it separately from other household waste Fulfill the requirements of Directive 98 79 EC on in vitro diagnostic medical devices Indicate that you should keep the analyzer dry Cauti...

Page 9: ...9 Abbreviations Abbreviation Description Comm Communication LIS Laboratory Information System HIS Hospital Information System GUI Graphic User Interface S W Software F W Firmware ...

Page 10: ...his Analyzer should be used only by trained operators If the error message occurs repeatedly stop using the Analyzer For accurate results refer to the manual that comes with each test device Do not use test devices which have expired To prevent electric shock Ensure the Analyzer is completely grounded Do not connect the Analyzer to an ungrounded outlet When using a power board use a grounded power...

Page 11: ...ance with federal state and local requirements Treat specimens as potentially biohazardous material If you have no experience with collection and handling of specimens appropriate education or guidance should be received Nitrile or latex gloves are recommended when handling patient specimens ...

Page 12: ...sor Inc For details regarding to specific tests refer to the user manual included with each test device package Product overview STANDARD F2400 Analyzer scans the 2D barcode of inserted test device Based on the scanned result of the inserted test device the analyzer determines the appropriate LED UV RGB settings for the test device An antigen antibody reaction takes a certain period of time after ...

Page 13: ...priate location since the Analyzer cannot be replaced or removed from power supply The Analyzer must be installed in such a way that easy access to power supply and power switch is ensured Specimens The STANDARD F2400 Analyzer should be only used the specific test devices for the analyzer Because specimens are quite different for each parameter follow the instructions from the each test device ins...

Page 14: ... to the instruction manual of the test device that you will use for analyses To perform a test with the Analyzer place the Analyzer on a flat surface Do not use the Analyzer near strong electromagnetic radiation sources Otherwise strong electromagnetic fields may affect the function of the Analyzer adversely If the Analyzer malfunctions suddenly unplug the power cable from the outlet Note It shall...

Page 15: ...0 Display Control Graphic User Interface Power Consumption Up to 84W Number of Memories 5 000 Run Test Real Time Clock Including RTC Backup Battery LIS HIS HL7 PCD 01 Profile Support Dimension 510 X 566 X 297 mm Inserts User Manual Bar Code Scanner Option USB Barcode Scanner Weight 20 kg ...

Page 16: ...16 Appearance of STANDARD F2400 Analyzer A D F G B C E I J K H ...

Page 17: ...open button Used to open printer cover F Mini USB Used to upgrade firmware by connecting with PC G LAN Used for communication using LAN Cable H AC power connection Used for AC power cable connection I Power switch Used to turn the Analyzer on off J USB x 4 Used to connect the Analyzer to keyboard barcode scanner and USB memory Note USB should be formatted as FAT32 so that the USB can be recognized...

Page 18: ...Accessories of the STANDARD F2400 Analyzer Accessories STANDARD F Calibration Set CAL 1 CAL 2 CAL 3 AC Power cable Optional STANDARD F Test Device Example HbA1c Influenza A B Barcode scanner Printer paper ...

Page 19: ...er Log On 2 1 Press log on button 2 2 The initial log on ID is admin and the password is 1111 Step 3 Analyzer Setting 3 1 When the Analyzer is set up for the first time user information must be registered 3 2 For initial setup select the Utility screen on the main screen The details of the setting Utility menu are shown below Step Menu Submenu 1 System Date Time Print Language Update Brightness Vo...

Page 20: ... can be used to set the Date Time Language Print Brightness Volume and proceed with the update System Menu 1 Date Time Setting Press an Up or Down button to change the year month date hour and minute The display type of year month and date and be changed Change the date style setting Year Month Day Month Day Year Day Month Year Time unit is changeable between 12 hours 12h and 24 hours 24h ...

Page 21: ...alyzer Software update file USB Not provided Personal computer Not provided How to update the software a Prepare a USB memory containing the F2400 s new software file ii Format USB as FAT32 file system iii Copy the software file to USB memory b Connect the USB that F2400 Software is copied to the USB port on the bottom left of the F2400 Analyzer c If the USB is connected normally USB connected suc...

Page 22: ...is displayed in the lower left corner of the screen F W Update Items needed for F W update STANDARD F2400 Analyzer Firmware update file Mini 5pin USB cable Personal computer Not provided How to update the F W a Connect your PC and device with a Mini USB cable If the driver is not recognized on PC install the CP2101 driver b Press FW update on the screen ...

Page 23: ...23 c Press OK d Run the PC program e When the Update Firmware button is enabled click the button f Click Update Firmware on the PC and then press OK on the Analyzer ...

Page 24: ...e is completed on the PC press the OK button h Press OK on the screen to complete FW Update 5 Brightness Volume setting Use buttons or the slider to adjust screen brightness Use buttons or the slider to adjust the volume ...

Page 25: ...The QC period can be set from due date in Area above Due Date Area You can set the period of test items Press button to select No QC Off or set the due date by 15 30 45 60 90 180 or 300 days Event Log Date Time Area Date and time of event log are displayed Event Log Area History of all items tested by F2400 Analyzer is displayed in chronological order Caution Log Clear Button Delete the selected e...

Page 26: ...times that each test has been performed is displayed The type and number of times of errors that occurred are displayed The number of times of calibrations and Q C for each test is displayed Period setting Press button to set the period that you want to check Caution Top Clear Delete selecte Bottom Clear Delete selected Cal QC Log ...

Page 27: ...27 Operator Menu 1 An Operator item can be registered edited and deleted Password in Operator is the same as the password used for log on To add an Operator ID press Add ...

Page 28: ...28 To modify the Operator ID select the ID press Edit type ID you wish to modify and then press OK ...

Page 29: ...the Operator ID select the ID select the ID press Delete then press OK Network Menu 1 On the Network tab you can set the HIS LIS and Analyzer network For the methods of setting consult with your interface specialist ...

Page 30: ...a test check the following Is the power cable connected to the Analyzer Are the date and time settings of the Analyzer correct Are all other settings correct 1 Select the Work Place from the Main Menu 2 The Work Place consists of 3 items Run Test Test Status and Result Review ...

Page 31: ...t step Patient ID can be entered by using the touch keyboard You can also enter Patient ID by using a barcode scanner or by an external keyboard connected by USB You can also press button to proceed with the test without enteringthe Patient ID Insert the test device in the Insert Device step and the Analyzer will move to the next step automatically ...

Page 32: ...sed E 1 error pops up After confirming that the test device can be used with STANDARD F2400 the samples should be prepared according to the instruction for each test and applied to the sample well of the test device Caution Press the Test Start immediately after applying the sample to the test device ...

Page 33: ...nalyzer checks the applied sample s conditions and flow When the sample checking is completed the test deviceis mounted inside the Analyzer When the mounting is completed you can start a new test procedure ...

Page 34: ...egative If the result of quantitative test is within the normal range Red section is shown in the following cases If the test is completed correctly If the result of qualitative test is positive If the result of quantitative test is out of normal range Black section is shown in the following cases If the test result is Invalid Green section is shown in the following cases If the test is in progres...

Page 35: ...ocedural control test date and time Operator ID Patient ID manufacturing date of the test deivce software version In this window you can print the test result by pressing on Print Press OK to close the window 3 Result Review Menu Result Review allows you to check the test results from Run Test ...

Page 36: ... belonging to the selected Patient ID will be shown in Area B If you select a particular test from the drop down list you can see the tests in order from the most recent ones A B If you select a test from the list in Area B you can see the test details Test details window for qualitative test Example Influenza A B ...

Page 37: ... quantitative test Example HbA1c For quantitative test you can change the measurement unit by pressing the item under Units in the list on the right side Area B Available only when there are 2 or more types of measurement units ...

Page 38: ...turned on When Analyzer is dropped When the result does not match the desired result When you want to check the performance of the Analyzer and test device Caution Calibration Set test is independent from QC test and cannot replace QC test Calibration mode consists of Run Calibration and Calibration Review 1 Run Calibration Menu Calibration can be performed in Run Calibration After preparation of ...

Page 39: ...evice into the test slot of the Analyzer After checking the Cal 1 Device insert the Cal 2 Device into the test slot of the Analyzer After checking the Cal 2 Device insert the Cal 3 Device into the test slot of the Analyzer ...

Page 40: ...r inserting all the calibration devices the analyzers performs the calibration analysis When the analysis is completed you can check the result screen Calibration check OK screen Calibration check FAIL screen ...

Page 41: ...libration Review Menu The result of calibration can be checked in Calibration Review You can check the details by selecting the Result from the list Calibration Review OK screen Calibration Review FAIL Screen ...

Page 42: ...42 Select a list and press Delete Record to clear the selected items Press the Delete All to clear all results ...

Page 43: ...When the result does not match the expected result When the result is lower or higher than expected even after repeated tests When you want to check the performance of the Analyzer and test device Before using the Control Check the expiration date of quality control material Do not use after expiration or disposal date 3 months after the package of quality control material is opened Consider the e...

Page 44: ...lution and the next screen will be shown Enter the information of quality control material barcode number and press OK to proceed to the next step Insert a test device that matches the quality control material information entered on the Insert Device screen ...

Page 45: ...e test device has already been used an E 1 error pops up When the verification of the test device is completed apply the control to the sample well of the test device and immediately press QC Start The F2400 Analyzer will check the conditions and flow of applied sample ...

Page 46: ...ted the test device is mounted inside the Analyzer Once the mounting is complete you can start a test procedure 2 External QC Press External QC to move to the next screen Insert the test device to test on the Insert Device screen ...

Page 47: ...ce has already been used an E 1 error pops up When the verification is completed a screen for setting the range of quality control material appears Set the information of the quality control material to be used and press OK to save the information Example of Qualitative test ...

Page 48: ...48 Example of Quantitative test After applying the prepared quality control material press QC Start immediately The F2400 Analyzer checks the conditions and flow of applied sample ...

Page 49: ... ⓔ ⓓ ⓑ a The number of times that QC was performed average standard deviation coefficient of variation and the result of 2SD are shown For qualitative items only the number of times is displayed For the quantitative items all values are displayed b The QC history of selected test is displayed in the No 4 drop down list d c You can set the date for desired period ...

Page 50: ...st Example The results obtained when result retrieval period is set to 2018 1 17 2018 4 19 and then HbA1c is selected from the drop down list Example The results obtained when result retrieval period is set to 2018 1 17 2018 4 19 and then Strep A is selected from the drop down list e Deletes the entire QC result ...

Page 51: ...e monthly value of quantitative test If you select the period and press Table the QC results for that period are provided in the form of a list Here you can check only the result of selected test by pressing Select item and selecting the desired item When a graph is selected the Levey Jennings control chart is provided ...

Page 52: ...reservatives Otherwise the display screen may be damaged Before cleaning always turn off the Analyzer and disconnect the power cables Maintenance and Transportation Each time you turn on the Analyzer the system in the Analyzer starts self verification to find any possible problem Note Be careful not to contaminate the test device slot and internal parts of the Analyzer The carrying case is designe...

Page 53: ...lyzer Solution Make sure that USB is properly inserted into the Analyzer Warning Password error Incorrect administrator password entered Solution Enter the correct password Warning No Update File Update file is not found in USB Solution Check USB for update file If you have confirmed that updated file is stored on the USB Insert the USB and press OK Warning Unregistered user information The entere...

Page 54: ...nated or already used Solution Discard the failed test device and retest with a new test device E02 Insufficient sample volume Insufficient sample is applied Solution Discard the failed test device and test again by dropping sufficient volume of sample on new test device E03 Expired test error A test device was used after expiration date Solution Perform the test again with new test device that ha...

Page 55: ...or cool the Analyzer E05 Communication error Communication between Analyzer and barcode or between Analyzer and printer has failed Solution If the error persists after rebooting the Analyzer consult the SD Biosensor E06 Total hemoglobin amount error The total hemoglobin measured deviates from the range of 7 23 g dL Solution Test again with a new test device If the error persists after rebooting th...

Page 56: ...ct the SD Biosensor E13 Unsuitable test device error Test device applied to Analyzer is not suitable Solution Check if the analyzer is updated with the latest version of the software EEE Analyzer internal error message Analyzer has an internal error Solution If the error persists after rebooting the Analyzer contact the SD Biosensor ...

Page 57: ...tromagnetic compatibility The electrostatic discharge immunity test shall comply with the international standard IEC 61000 4 2 In addition this Analyzer meets electromagnetic compatibility requirements in accordance with EN 61326 and there is no interference with other electronic equipment Disposal Dispose of the STANDARD F2400 Analyzer in accordance with local regulations for disposal of electric...

Page 58: ...58 MEMO ...

Page 59: ...59 MEMO ...

Page 60: ...ffice C 4th 5th 16 Deogyeong daero 1556beon gil Yeongtong gu Suwon si Gyeonggi do 16690 REPUBLIC OF KOREA Manufacturing site 74 Osongsaengmyeong 4 ro Osong eup Heungdeok gu Cheongju si Chungcheongbuk do 28161 REPUBLIC OF KOREA www sdbiosensor com ...

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