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6 Quality Control

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897N120152H FDC NX10N Instruction Manual 04.2022

Содержание DRI-CHEM NX10N

Страница 1: ...hen operating it Please read this manual thoroughly before actually operating the FUJI DRI CHEM NX10N After reading this manual store it nearby the FUJI DRI CHEM NX10N so that you can see it whenever...

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Страница 3: ...malfunctions and damage of FUJIFILM products due to the use of products of other manufacturers not supplied by FUJIFILM 5 FUJIFILM shall not be liable for malfunctions and damage resulting from remode...

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Страница 5: ...n Site Requirements 1 4 1 9 Test Results for Diagnosis 1 5 1 10 Pipettes 1 5 1 11 FUJI DRI CHEM SLIDEs NH3 WII NH3 PII 1 6 1 12 QC Card System 1 6 1 13 Handling Samples 1 6 1 14 FUJI CLEAN TIPS 1 7 1...

Страница 6: ...he Slide Transfer Part 5 4 5 4 Cleaning the Disposal Box 5 5 5 5 Cleaning the Air Filter 5 6 6 Quality Control 6 1 6 1 Control Fluids 6 1 6 2 Running the Control Fluid the QN 6 1 6 3 Monitoring Result...

Страница 7: ...1 Mode 9 Switching Display Method for Values outside of the Determination Range Admini 8 18 8 12 Mode 10 Correlation Coefficients a b Settings Admini 8 19 8 13 Mode 11 Lot compensation coefficients c...

Страница 8: ...897N120152H FDC NX10N Instruction Manual 04 2022 iv Contents...

Страница 9: ...ore Operating This Equipment CAUTION Before using this equipment please read this Instruction Manual carefully so that you can operate the equipment correctly Whenever you operate this equipment be su...

Страница 10: ...cessary Do not touch used slides and tips with bare hands as this may cause contamination If any part of the body comes in contact with contaminated consumables immediately rinse the contaminated body...

Страница 11: ...evice Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to which the other device s are connected Consult the manufacturer or field se...

Страница 12: ...ge limit 100 240V Frequency 50 60 Hz Supply voltage fluctuations 10 Rated current 0 6 A Phase Single Type of protection against electrical shock CLASS 2 EQUIPMENT 3 Plug the FDC NX10N into an independ...

Страница 13: ...e during test processing or warning indications are printed out along with test results the test results may NOT be accurate Re fer to Sec 7 Troubleshooting and rerun the tests To maintain the accurac...

Страница 14: ...s lab coat and safety goggles referring to the sample handling rules of your facility If any part of the body comes in contact with samples immediately rinse the contaminated body part thoroughly unde...

Страница 15: ...caution label Power switch Depress to power ON O Depress to power OFF The photometer and the upper heater Refer to P2 1 may become extremely hot when an abnormality occurs in the analyzer To open the...

Страница 16: ...cuments Biological risks High temperature caution Power switch Fragile item handle carefully Protect from rain This way up 11 Stacking limitation Temperature limitation Manufacturer SN Serial number C...

Страница 17: ...1 Safe Usage and Handling Precautions 1 9 1 897N120152H FDC NX10N Instruction Manual 04 2022 Sign Description Importer Consult Instructions for Use Unique device identifier Near patient testing...

Страница 18: ...1 Safe Usage and Handling Precautions 1 10 1 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 19: ...Component Names and Functions 2 1 Component Names Disposal box Keyboard Display Power switch QC card reader Pipette guide Slide loading part Pipette cover Measurement Part Photometer Pipette cover Upp...

Страница 20: ...nent Names and Functions 2 2 2 897N120152H FDC NX10N Instruction Manual 04 2022 USB A type x 2 USB B type Air Filter Connector for AC adapter connection AC Adapter The mark is the mark of the Class II...

Страница 21: ...n lot number by reading the QC card Countdown Displays remaining time mm ss before the test is complete It counts down by 10 seconds for a minute to go by a second for less than a minute to go 2 2 2 K...

Страница 22: ...a coefficient RERUN RERUN Down Minus key RERUN key The RERUN key is used for rerunning a test with the same sample ID used in the most recent measurement NOTE The RERUN key does not function for pre...

Страница 23: ...reach room temperature 3 2 Setting the Sample and Starting Measurements Attach a tip from FUJI CLEAN TIPS to the 10 L pipette and aspirate sample Make a drop above a slid and then place the drop on th...

Страница 24: ...3 Principles of Operation 3 2 3 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 25: ...se 1 WARNING Do not touch used slides and tips with bare hands as this may cause contamination If any part of the body comes in contact with contaminated consumables immediately rinse the contaminated...

Страница 26: ...for details NOTE Turn on the external printer before turning on the analyzer Activate and prepare the host computer for re ceiving a transmission in the time between turn ing on the analyzer and star...

Страница 27: ...02 10 00 W a r m i n g u p LotNo 123456 P The message shown on the left appears on the dis play and warming up temperature control starts IMPORTANT The lot number of the QC card most recently read app...

Страница 28: ...o 123456 W 1 Make sure that Ready is displayed and the READY lamp is green NOTE The indication W on the display means that the whole blood slide FUJI DRI CHEM SLIDE NH3 WII has been selected The indic...

Страница 29: ...t recent measurement 1 is displayed for the next measurement except when the sam ple ID was set by the sample barcode reader N H 3 W 4 Place a slide on the analyzer IMPORTANT Place a slide properly wi...

Страница 30: ...may result Make a small drop and move the tip of the pipette closer to the slide The drop spreads on the slide Place the drop in a range within 1 mm from the center of the slide a Move the tip of the...

Страница 31: ...on the left appears during cal culation The test result is displayed when calculation is com pleted 8 When the test finishes the used slide is ejected into the disposal box 9 By pressing the C key th...

Страница 32: ...progress NOTE Do not turn off the power during measurement processes and mode operations Otherwise physical damage may occur to data in the equipment 2 Turn the power switch off Depress the O side of...

Страница 33: ...dated In addition to the lot compensation coefficients each QC card also has slide data essential for performing measurements Therefore read in the new QC cards when you switch to a new box of slides...

Страница 34: ...vate and prepare the host computer for receiving a transmission in the time between turning on the analyzer and starting measurements NOTE To connect the host computer it requires installation of the...

Страница 35: ...h the sample barcode reader before using it A maximum of 13 numbers can be input for a sample ID Always use the sample barcode reader below 3 000 cd m2 lux avoiding direct sunlight Turn on the analyze...

Страница 36: ...the sample ID will be displayed IMPORTANT Make sure that the barcode data sample ID shown on the display is correct NOTE When rereading the barcode data press the button of the sample barcode reader a...

Страница 37: ...eys delete the currently displayed number by the C clear key and then input a sample ID by numeric keys The sample ID starting with 0 is not changed by numeric keys 2015 12 02 10 00 R e a d y ID 1 Lot...

Страница 38: ...ID 101 LotNo 123456 W 2015 12 02 11 20 R e a d y ID 100 LotNo 123456 W Sample 1 Sample 3 Change the sample ID from 2 to 100 Automatically updated sample ID Example When running tests with a sample ID...

Страница 39: ...plicable regulations in your country such as by incineration melting sterilization or disinfection CAUTION Users must perform cleaning and maintenance after having training conducted by our designated...

Страница 40: ...points Cleaning interval Procedure Photometer Monthly or when inaccurate test results occur Refer to Section 5 2 Slide loading part transfer part Monthly or when they are dirty Refer to Section 5 3 Di...

Страница 41: ...he USB cable and the like and be sure to check the operation of the analyzer by turning on the power switch Pipette cover Transfer frame Cleaning procedures 1 Turn off the power of FDC NX10N and remov...

Страница 42: ...ansfer frame Cleaning procedures 1 Turn off the power of FDC NX10N and remove the AC power cable the USB cable and the like from the connector 2 Open the pipette cover and the transfer frame Slide tra...

Страница 43: ...tion or disinfection IMPORTANT After cleaning the analyzer restore the connection of the AC power cable the USB cable and the like and be sure to check the operation of the analyzer by turning on the...

Страница 44: ...he analyzer restore the connection of the AC power cable the USB cable and the like and be sure to check the operation of the analyzer by turning on the power switch Air filter Cleaning procedures 1 T...

Страница 45: ...control results 6 4 Control Mode By using the Control of mode function the control fluids are tested under the condition of correlation coef ficients a b for all tests reset to a 1 and b 0 After compl...

Страница 46: ...6 Quality Control 6 2 6 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 47: ...4 W0610 W0611 Test value errors 7 2 6 7 4 E1500 E1552 Temperature control errors 7 2 7 7 5 W2201 Host computer connection errors 7 2 8 7 6 W2401 W2403 Printer errors 7 2 9 7 6 E3000 E3050 Data errors...

Страница 48: ...s NOTE Switching of the reference values such as or can be set by using the mode 9 shown at Mode 9 Switch ing Display Method for Values outside of the Determination Range of mode function Refer to Sec...

Страница 49: ...e disposal box Refer to P5 3 5 5 If the error still occurs please contact your technical support dealer for assistance E0201 Feed motor ERR Sensor OFF failure E0202 Feed motor ERR Test Sensor ON failu...

Страница 50: ...t Set the date and time using the Date Time settings of mode function Refer to P8 6 If the error still occurs please contact your technical support dealer for assistance NOTE Turning the power on for...

Страница 51: ...er deg E1520 Upper sensor break Contact your dealer Temperature control function of the photometer or the upper heater has malfunctioned Turn the power switch off and on If the error still occurs plea...

Страница 52: ...onnection Host computer communication has malfunctioned Make sure that the USB cable has been connected properly and that the status of the host computer is ready to communicate Refer to P4 10 If the...

Страница 53: ...ts corresponding slides IMPORTANT If a QC card other than the one packed with slides is used for measurement it may affect on the test results E4011 QC card is NOT NH3 Check the QC card E4012 QC card...

Страница 54: ...7 Troubleshooting 7 8 7 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 55: ...by the administrators who have the responsibility for the use of the analyzer Inputting a password in Mode 0 allows the administrators to operate the administrator modes Mode number Mode description...

Страница 56: ...RERUN 1 To enter a mode operation There are 2 ways to select a mode Selecting the desired mode by scrolling a Inputting the desired mode number directly b a Selecting the desired mode by scrolling On...

Страница 57: ...conditions shown at the left press the MODE key to display the mode number in put dialog Input a Mode No from the keyboard and press the ENTER key to display the first dialog of the mode NOTE or indic...

Страница 58: ...scroll keys then press the ENTER key NOTE Although the service mode will be displayed on the menu the mode is not available To enter Administrator mode input the password JCPIG OQFG 2CUUYQTF JCPIG OQ...

Страница 59: ...No NOTE The control mode will be canceled after turning the analyzer off and turn it back on MODE START 1 Enter into Mode 1 Quits Mode A beep sounds when saving data is complete Displayed about two s...

Страница 60: ...the effective range a beep sounds and the display returns to re input status If the C clear key is pressed when a cursor is located in the Y line having no data input the analyzer quits the mode opera...

Страница 61: ...al printer 0 DWH WLPH 0 K P 0 DWH WLPH 0 K P A beep sounds when saving data is complete START START 3 Input time NOTE If an input value is outside the effective range a beep sounds and the display ret...

Страница 62: ...Mode A beep sounds when saving data is complete Displayed about two seconds Printed by the external printer CVG HQTOCV CVG HQTOCV 5CXKPI Q 016 RQYGT QHH START Select MODE RERUN 2 Select a date displa...

Страница 63: ...ata or Control data by the scroll keys then press the ENTER key NOTE The shaded part is a selected menu The test result dialog is displayed with routine test data or control data NOTE If measurement i...

Страница 64: ...it data and then press the ENTER key NOTE After a beep sounds and the message is dis played about two seconds the analyzer returns to the test result screen If the host computer is not connected 9 0Q...

Страница 65: ...nt data and then press the ENTER key NOTE After a beep sounds and the message is dis played for about two seconds the analyzer re turns to the test result screen If the printer is not connected 9 0Q R...

Страница 66: ...0Q VGUV TGUWNVU HQWPF If the printer is not connected 9 0Q RTKPVGT EQPPGEVGF 6WTP RQYGT 59 1 JGEM VJG EQPPGEVKQP 2 Select the test data a Select routine test data or control data Select Routine test d...

Страница 67: ...tion Manual 04 2022 Supplement Example printout Select the routine test data 0 DWFK SULQW uJ GO RW1R 3 uJ GO RW1R 3 Select the control data 0 DWFK SULQW RQWURO uJ GO RW1R 3 RQWURO uJ GO RW1R 3 Data pr...

Страница 68: ...eep sounds and the message is dis played about two seconds the analyzer quits the mode operation If the error log does not exist 0Q GTTQT KPHQ Quits Mode Select Display using the MODE RERUN START Sele...

Страница 69: ...PVGT EQPPGEVGF 6WTP RQYGT 59 1 JGEM VJG EQPPGEVKQP Printing all is complete Quits Mode Select Print using the MODE RERUN START TTQT NQI KURNC 2TKPV 3 When the external printer is connected print the e...

Страница 70: ...analyzer MODE START 1 Enter into Mode 7 Quits Mode A beep sounds when processing data is complete Displayed about five seconds Printed by the external printer 0 LVSOD WHPS 8SSHU KHDWHU RZHU KHDWHU WHP...

Страница 71: ...he analyzer quits the mode operation If the QC card information does not exist 0Q 3 KPHQ 2 Select a unit Select a unit by the or key and then press the ENTER key Unit A Unit B Conversion Factor g dl m...

Страница 72: ...e 9 5CXKPI Q 016 RQYGT QHH 1WV QH TCPIG HNCI 1WV QH TCPIG HNCI 1WV QH TCPIG HNCI 1WV QH TCPIG HNCI Quits Mode A beep sounds when saving data is complete Displayed about two seconds Printed by the exte...

Страница 73: ...1 Enter into Mode 10 NOTE After a beep sounds and the message is dis played about two seconds the analyzer quits the mode operation If the QC card information does not exist 0Q 3 KPHQ Printed by the...

Страница 74: ...DWD 5HVHW 17 5 QSXW 0 RUUHODWLRQ GDWD D E 17 5 QSXW 0 RUUHODWLRQ GDWD QSXW 3ULQW 0 RUUHODWLRQ GDWD QSXW 5HVHW 0 RUUHODWLRQ GDWD QSXW D E 3 Select correlation data a Press the ENTER key b Select Input...

Страница 75: ...s complete d Input a new value for coefficient a The current value is displayed Input a new value for a using numeric keys and press the ENTER key NOTE If an input value is outside the effective range...

Страница 76: ...y the external printer Select Select Input the administrator password A beep sounds when saving data is complete 4 Reset coefficients a Select Reset and press the ENTER key b Select whether to reset t...

Страница 77: ...wo coefficients a b are re corded in the analyzer memory the FDC NX10N per forms compensation calculations internally using the formula X Y b a In this way the FDC NX10N s measured data Y are adjusted...

Страница 78: ...Y X Y X Y 1 1X 5 4 Measurement range after inputting coefficients a b Depending on the values input for a b the apparent limits of the measurement range will shift as follows If a 1 and b 0 Y X the me...

Страница 79: ...FRHIILFLHQWV QSXW RW1R F G H START START 2 Press the ENTER key NOTE If the external printer is connected Input and Print are displayed Select Input and then press the ENTER key to display the input d...

Страница 80: ...efficient c example c 4 560 Input a new value for coefficient e example e 0 500 0 RW FRHIILFLHQWV QSXW RW1R F G H 0 RW FRHIILFLHQWV QSXW RW1R F G H 0 RW FRHIILFLHQWV QSXW RW1R F G H START RERUN MODE M...

Страница 81: ...nput a new value for expiration month M example M 06 A beep sounds when saving data is complete Printed by the external printer Input the administrator password e Input a value for year and then press...

Страница 82: ...operation If the QC card information does not exist 0Q 3 KPHQ Select Print using the MODE RERUN START Display when all tests are reset Display with some ongoing tests Printed by the external printer S...

Страница 83: ...LQWHUYDOV 5HVHW 17 5 QSXW 0 5HI LQWHUYDOV 1 3 XJ GO 17 5 QSXW 0 5HI LQWHUYDOV QSXW 3ULQW 0 5HI LQWHUYDOV QSXW LQWHUYDO GG WR UHVXOWV 3 Input a reference interval NOTE To reset in the reference interva...

Страница 84: ...PRWV KPVGTXCN 0 2 WI FN QYGT 7RRGT 4GH KPVGTXCNU PRWV KPVGTXCN 0 2 WI FN QYGT 7RRGT 5CXKPI Q 016 RQYGT QHH 4GH KPVGTXCNU 0 2 WI FN 06 4 PRWV START START START d Input a lower limit value After the inp...

Страница 85: ...0Q 4GH KPVGTXCNU FF VQ TGUWNVU GU 0Q 4GH KPVGTXCNU FF VQ TGUWNVU 4GH KPVGTXCNU Q 016 CFF VQ TGUWNVU 4GH KPVGTXCNU PRWV KPVGTXCN FF VQ TGUWNVU 4GH KPVGTXCNU PRWV KPVGTXCN FF VQ TGUWNVU 4 Select whethe...

Страница 86: ...ng data is complete Displayed about two seconds Printed by the external printer 5CXKPI Q 016 RQYGT QHH 5GNGEV NCPIWCIG CRCPGUG PINKUJ 5GNGEV NCPIWCIG CRCPGUG PINKUJ 5GNGEV NCPIWCIG CPIWCIG PINKUJ 5GNG...

Страница 87: ...F UQWPF W GT CFLWUVOGPV TTQT UQWPF A W GT CFLWUVOGPV 6GUV GPF UQWPF AA 2 Select Error sound or Test end sound Select a menu Error sound or Test end sound using the keys and press the ENTER key a To ch...

Страница 88: ...ERUN A beep sounds when saving data is complete Displayed about two seconds Printed by the external printer 5CXKPI Q 016 RQYGT QHH QPVTCUV CFLWUV 0GY EQPVTCUV QPVTCUV CFLWUV KURNC EQPVTCUV 4CPIG START...

Страница 89: ...VW GDWD RQWURO GDWD 0 GLW RQWURO XJ GO RW1R 3 START Select MODE RERUN START Select MODE RERUN 2 Display the test data a Select the routine test data or control data Select Routine test data or Control...

Страница 90: ...be dis played Make sure that the IDs before editing OLD xxxx and after editing NEW xxxx are correct 5 Accept the edited result After confirming the edited result select any of the following options us...

Страница 91: ...e Saving Do NOT power off START or A beep sounds when saving data is complete Displayed about two seconds Quits Mode Printed by the external printer Edit password 2 Edit the password using numeric key...

Страница 92: ...8 Mode Settings and Functions 8 38 8 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 93: ...preparations such as the installation of the specified device driver are required for the host computer When using this function for the first time please contact your technical support dealer for ass...

Страница 94: ...9 Other Functions 9 2 9 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 95: ...conditions Operating temperature 15 to 32 C 59 to 89 F Operating humidity 30 to 80 RH no vapor condensation Storage and transportation conditions Temperature 10 to 50 C 14 to 122 F Humidity 10 to 90...

Страница 96: ...n AC power cable conforming to the specifications below The requirements of the cable specifications for the FDC NX10N Power voltage 200V 240V Requirements of the plug connector AC250V 2 5A Requiremen...

Страница 97: ...e FUJI DRI CHEM SLIDE NH3 WII 24 slides per box FUJI DRI CHEM SLIDE NH3 PII 24 slides per box FUJI CLEAN TIPS 1 96 tips x 6 cases per box FUJI DRI CHEM CONTROL QN 3 ml x 2 pcs per box Recording paper...

Страница 98: ...10 Specifications Consumables 10 4 10 897N120152H FDC NX10N Instruction Manual 04 2022...

Страница 99: ...Second calibration calibration colorimetric coefficient communication control dilution error expiration horizontal incubator information keyboard No Good Normal Saline Solution Optical Density paramet...

Страница 100: ...11 Glossary 11 2 11 897N120152H FDC NX10N Instruction Manual 04 2022...

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Страница 102: ...26 30 NISHIAZABU 2 CHOME MINATO KU TOKYO 106 8620 JAPAN https www fujifilm com EU Balcke Duerr Allee 6 40882 Ratingen Germany Oudenstaart 1 5047 TK Tilburg The Netherlands...

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