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Arkray Spotchem SP-4430 - Frank`s Hospital Workshop

1. range 5 End setting e Press STOP key twice to return to the MAIN MENU Measure Submenu Calibrate 0000 3 22 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 3 4 Maintenance Chapter 3 SUB MENU Proper maintenance is required to maintain the accuracy of the analyzer Select Maintenance on the SUB MENU to perform either daily maintenance or periodical maintenance 1 Preparation for the maintenance e Press 2 key on the MAIN MENU SUB MENU1 2 is displayed asumen Calibrate Results PARAM _Maintenance 0000 e Press 3 The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi rack slide forward When the message is displayed as shown on the right turn off the Please turn off power 2 Perform maintenance Perform maintenance of each part see Chapter 4 MAINTENANCE 3 End maintenance e Turn ON the power Warm up starts the Reagent Table and the Centrifuge equipped Multi rack slide back to the original position and the Table Cover closes e After the warm up is completed MAIN MENU is restored Measure Submenu Calibrate 0000 SP 4430 3 23 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 3 5 Mode Menu Chapter 3 SUB MENU p gt The
2. Be careful not to spill sample blood when uncapping the tube 1 Display the Standby screen p gt START key can be used Press 1 key on the MAIN MENU instead of 1 key Measure j Submenu The Table Cover opens and the Reagent Strip Table and Centrifuge equipped Multi Rack slide forward Calibrate 0000 The Standby screen is displayed as shown at the right Standby 000000000 ID 00 2 Check the time and date Make sure that the time and date the Standby screen is correct If not set a correct time and date see 3 6 Built in Clock Adjustment IMPORTANT If a wrong date is set correct measurement results may not be obtained Before measurement make sure that the date is correct 2 18 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 3 Check the lot number of Reagent Strips e Press 2 key on the Standby screen 00 GGT XXXXXX CARD The Confirm screen is displayed which indicates information of Reagent Strips stored in memory pe check numerous test items Check that the test items and lot at one time print out the lot numbers of all items Press 3 key on the Standby match with those shown on the numbers of the Reagent Strips Il the scr
3. Measure Submenu Calibrate 0000 SP 4430 3 25 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL MEMO 3 26 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE Proper maintenance is required to maintain satisfactory measurement This chapter describes maintenance and replacement of consumables 4 1 Outline of Maintenance 4 1 1 Frequency of Maintenance 4 2 Daily Maintenance 4 2 1 Cleaning the Reagent Table 4 2 2 Cleaning the Tip Waste Case and Protective Cover 4 3 Periodic Maintenance 4 3 1 Replacement of Thermal Printer Paper 4 3 2 Cleaning the Optical Window 4 3 3 Cleaning the Nozzle 4 8 4 Replacement of Nozzle SP 4430 6 4 01 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 4 1 Outline of Maintenance Chapter 4 MAINTENANCE 4 1 1 Frequency of Maintenance The following table shows the parts requiring maintenance and the frequency of maintenance Perform daily or periodical maintenance according to the table Cleaning part Frequency Page Cleaning of Reagent Table Daily 4 03 Cleaning of Tip Waste Case Daily 4 06 Cleaning of Protective Cover 4 07 Replacement of When a red line appears on 4 08 Thermal Printer Paper both sides of printer paper Cleaning of Optical Window Once every 2 000 measurements 4 10 Cleani
4. Calibrate 0000 SP 4430 6 2 11 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 2 3 3 Checks before measurement Check each part before performing Normal Measurement or Calibration WARNING Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective gloves separately from general waste according to the local regulations on biohazardous waste 1 Thermal printer paper f a red line appears both sides of the printer paper replace it with a em new roll see 4 3 1 Thermal printer paper replacement 2 Reagent Table e Check the Reagent Table and clean ama it if necessary see 4 2 1 Cleaning the Reagent Table 3 Centrifuge equipped Multi Rack eMake sure that the Centrifuge equipped Multi Rack has no used samples in it If any discard them e Install the Tip Waste Case 4 Setting the parameters e Set the parameters as necessary If the same parameter settings are continuously used resetting is not necessary See Chapter 3 SUB MENU for details IMPORTANT To check the present parameter settings print them out See 3 3 1 Printing parameters 2 12 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 3 4 Preparation of samples
5. Measurement date Year The last two digits of year month 17 12 dare 17531 zero control YMD formi ar is always applied regardless of the date setting Measurement date Time 0723 Minute 0759 zero control 055 Data error Mormalz Under the rangez1 Over the range or prozone error OY ER 2 Low value 3 High valuez4 Prozone error CAM T MEAS I 5 Calibration error by magnetic card L1 6 alibraton error of magnetic card H1 7 OTEO 2 25 0 U4 tem s other than enzyme os Mame of Multi Reagent Strip Far Single Reagent Strip blank 20H is used 951 ass a Measurement value When the dara errors 1 lower value the dats emorzz 5 5 7 upper values are applied 6 08 SP 4430 lllConsumable Accessories Item Specifications Qty Product code Thermal Printer Paper For Built in Printer 58 mm width 1 10067 Serum Sample Tube 100 pieces blue cap 1 10204 Serum Sample Tube 500 pieces blue cap 1 10191 Whole Blood Sample Tube 100 pieces orange cap 1 10202 Whole Blood Sample Tube 500 pieces orange cap 1 10192 Diluent for Hb measurement 20 mL 50 pieces 1 10200 Pipette Tip for Hb Meas 100 L 960 pieces 1 10206 Pipette Tip for Hb Meas 1000 ul 960 pieces 1 10207 Calibrator Kit Low an
6. results Press 5 key again to return the Standby screen NOTE Only measurement item and its result are displayed Channel numbers unit symbols and others such as A V are not displayed When the details are to be confirmed thermal printer paper is set for allowing the results to be available in print To check the detailed results set printer paper and print out the measurement result 2 26 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT Remove any used Reagent Strips and discard them When the message DISCARD TIPS is displayed remove the Tip Waste Case and discard used tips Reattach the Tip Waste Case To discontinue measurement press STOP key to return to the MAIN MENU Remove used tips OK ENTER NOTE The message DISCARD TIPS appears once every five measurements When the message is displayed discard the tips Otherwise a trouble may occur 11 End measurement for the day After finishing all measurement for the day perform daily maintenance see 4 2 Daily Maintenance SP 4430 2 27 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 2 5 C alibration Chapter2 MEASUREMENT 2 5 1 Overview of calibration Calibration is necessary to maintain measurement accuracy Calibration reduces unfavorable effects of reagent pack that ch
7. SP 4430 3 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 3 2 2 Transmit measurement results gt if STOP key is pressed during Transmit measurement results Max 100 measurements stored in the operation the previous screen is restored memory 22 i The following three types for transmission are available pe case hierar mission l LATEST The latest measurement result one measurement measurement results are printed out starting from the 2 ALL All measurement results Max 100 measurements latest result stored in the memory 3 SEARCH The measurement results searched by the date range and or ID 1 Display setting screen Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Me supmenu DD D Results PARAM 0000 Press 1 key The MEASUREMENT RESULTS Print Send MENU is displayed Delete 00000 2 Select measurement results to transmit Press 2 key Latest Search The Select Results screen is displayed Select the measurement results to transmit by using numeric keys l LATEST the latest measurement result 1 measurement 2 ALL all measurement results 3 SEARCH the searched measurement results by date and ID When LATEST or ALL is selected Retransmission starts immediately After ret
8. Remove a Reagent Strip from the aluminum foil package without touching the reagent field with the fingers Place the Reagent Strips on the Reagent Table by holding the right side of the strip IMPORTANT Be sure to insert the end of a Reagent Strip into the groove of the Reagent Table so that the Reagent Strip stays firmly in place If the Reagent Strips are bent or placed out of the groove it may become jammed or correct measurement results may not be obtained Set the Single type Reagent Strips Open the aluminum foil package ofa Reagent Strip by tearing straight down from the V shaped notch Tearing zightdown tom the Wahaped 2 24 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT IMPORTANT p gt discontinue the measurement press STOP key to return to the Standby screen Remove the Reagent Strip from the package without touching the reagent field with fingers Insert Reagent Strips on the Reagent Table as shown at right Be sure to insert the end of a Reagent Strip into the groove of the Reagent Table so that the Reagent Strip stays firmly in place If the Reagent Strips are bent or placed out of the groove it may become jammed or correct measurement results may not be obtained 9 Start the measurement Press START key The Reagent T
9. pe The numeric keys and keys can be used in selecting items For example to entry man 61612 1212121616 6616116 0 key can be used to input the following 12 symbols which are HOB 0 Shy gt gt To delete the name press key to make it blank Press Enter key Enter sample types to measure The entered types are printed out with the measurement results Maximum 5 different types can be set 1 Display the screen Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure 5 Calibrate 0000 Results PARAM 0000 Press 2 key The PARAMETER MENU 1 2 is displayed Initiali e Press Menu key or key 0 0000 0 00 pu Press 4 key The Sample type 1 name entering screen is displayed 00000 oO 2 Enter the sample type Maximum 5 letters can be entered using numbers letters and symbols U Press Enter key The Sample type 2 name entering screen is displayed HOU 00000 d e Similarly enter the sample types 2 to 5 When no sample type is set press Enter key with the space kept blank SP 4430 3 19 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 3 Setting the sample type to use on the basic setting
10. 20 256 humidity IEEE IE e Before turning ON the power reconfirm The analyzer has a temperature control lf there is anything wrong with the 1 4 1 Cautions so that the analyzer is function in order to yield correct analyzer or in case of odor or smoke always operated under proper measurement results at the room turn OFF the power immediately and conditions temperature of 10 30 C For more unplug Otherwise the analyzer may accurate measurement measurement at be damaged and cause fire the room temperature of 20 25 C and at humidity of 30 60 is recommended e If the analyzer is out of order contact eDo NOT put a container with samples Do NOT move the analyzer during your distributor for repair Do NOT in it on the analyzer If samples spill measurement Such movement may attempt to repair or modify it by on the device it may damage cause malfunction resulting in yourself It may damage the analyzer incorrect measurement results or get injured LEES aL e Perform proper maintenance following NOT place anything in front of the Use SPOTCHEM Reagent Strips only the instruction to ensure high Table Cover It automatically opens for the analyzer The other types of accuracy during operation Reagent Strips are unacceptable 2 06 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUR
11. 6 06 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 6 APPENDIX ei Data errors In the Reagent Ship and Single Reagent Strip messurem ent resulte dara parts For each item 22 bytes including end CRILF are output follows when asure ment errors occur ats seit prozone O YER m ee pees the range Fixed character string OVER l nder the range Fined character string UNDER Prozone OVER Fixed character sting OVER the range Upper limit of messurement range l nder the range Lower limit of measurement range Prozone OVER Upper limit of m exsurem ent range Temperature Blank 20H lems other han enzyme Blank ee MEAS or calibration eror by magnetic card E ee eee mm m Error message Prozone CANT MEAS CANT MEAS card CAL error L CAL ERROR L1 Magnetic card CAL error H CAL ERROR Temperature Blank 20H 2DE lems other than enzyme Blank SP 4430 6 07 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 6 APPENDIX 6 1 4 Format of measurement results format 2 The measurement result format 2 is the same as the extended form
12. Remedy 109 000 0000 Lg aa gan e Trouble occurred in the pump driving mechanism e Turn on the power again e f the same trouble occurs contact your distributor T12 000 0000000 0000 Lag addu e The optimal gain could not be set e Turn on the power again e If the same trouble occurs contact your distributor NOTE If measurement is started though trouble is detected when the power turned on trouble occurs at the start of measurement and the measurement cannot be performed T13 HOU 00000000000 e Trouble occurred in the internal calculation operation e f the same trouble occurs contact your distributor Ug ag gua m 000000000 000 0 000000000 High the case in which the counted value is greater than the setup range Low the case in which the counted value is smaller than the setup range LED is not lit LED is deteriorated Turn on the power again If the same trouble occurs contact your distributor T17 m 000000 00000 0010 0 000000000 PMC When trouble occurs on PMC SUB When trouble occurs on the sub CPU Trouble occurred in an electrical component Turn on the power again the same trouble occurs contact your distributor T20 HOU 000 0000000 00000000 Forgot to set tips Failure in setting tip mount Set the
13. SP 4430 1 11 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION 1 4 2 1 12 SP 4430 Setting up the analyzer The parts in the analyzer are secured firmly in order to prevent scratches and or damage due to transportation Remove the fixing tapes before setting up the analyzer Read 1 4 1 Cautions on installation carefully before setting up the analyzer 1 Remove the fixing tape Remove the tape fixing the table cover RN e Open the maintenance cover and remove the tape fixing the nozzle e Reattach the maintenance cover 2 Connect the power cord e Make sure that the power switch on the rear of the analyzer is OFF e Connect the AC adapter to the receptacle on the rear panel of the analyzer and plug the other end of the cord into the AC outlet 3 Connecting an external device if necessary e When using an external device connect the exclusive connecting cable to COM on the rear panel of the analyzer SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION 1 4 3 First operation after setting up This section explains the way to load thermal printer paper and set data and time after turning on the power switch 1 Turn on the power e Turn on the power switch on the rear SPOTCHEM EZ panel of the analyzer SPUUU00 VXXXX I is disp
14. TROUBLESHOOTING Chapter 6 APPENDIX 2 5 2 6 3 1 3 2 ug o WN Calibration reto 2 28 2 5 1 Overview of calibration 2 28 2 5 2 Calibration by magnetic 2 29 2 5 3 Calibration by calibrator kit 2 31 Interpreting measurement results 2 39 2 6 1 Printing normal measurement results 2 39 2 6 2 Printing calibration results 2 42 Overview of SUB 3 02 3 1 1 Composition of SUB MENU e 3 02 Measurement Results 3 04 3 2 1 Print measurement results 3 04 3 2 2 Transmit measurement 3 06 3 2 3 Delete measurement 3 08 Parameter Menu RR 3 10 3 3 1 Print 3 10 3 3 2 Enter parameters Rm 3 13 3 3 3 Initialize 3 17 3 3 4 Enter sample type Adsl aly 3 19 3 3 5 Copy standard range setting 3 21 Maintenance 3 23 Mode 3 24 Built in Clock Adjustment E E aah 3 25 Outline of _ 4 02 4 1 1 Frequency of Maintenance 4 02 Daily Maintenahce emm et 4 03 4 2 1 Cleaning the Rea
15. When prozone errors occur the types of errors are printed ex Amy When the unit other than the conventional units is used or a coefficient of correlation correction is entered is printed on the right of the first number of the measurement result ex Alb 2 40 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT p Generally mg conventional unit is used for unit To change the unit contact your distributor 2 Survey Mode printing for 1 item Alb 5 2 gdl 5 4 Eg dl Temperature conversion 1 000 Unit corwergion mg Ku 1 000 Correlation correction Acor 0 923 Boor 0 wo 1 Measurement value which temperature conversion unit conversion or correlation correction is not applied 2 Temperature Printed out as for the items other than enzyme items Temperature conversion factor Conversion factor when the standard temperature is 37C 4 Unit mg is the conventional unit SI is SI unit and User is units set by users 5 Unit conversion factor Conversion factor when the conventional unit is standard 6 Coefficient of correlation correction Coefficient set in the Entering parameters on the Sub Menu SP 4430 6 2 41 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 2 6 2 Printing calibration results The calibration re
16. With numerous measurements sample blood residue may stay inside the Nozzle and cause clogging Clean the Nozzle once every 10 000 measurements or once a year Nozzle cleaning wire Tweezers Tissue paper and Protective gloves Wear protective gloves to prevent exposure to pathogenic microbes Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste 1 Move the Nozzle to stand by position Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Submenu Calibrate Press 3 Results PARAM Maintenance 0000 The Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack slide forward The Nozzle Driving Unit moves to Ready the left end in the analyzer Please turn off Turn OFF the power Make sure the power is OFF before moving on to the next procedure Otherwise it may cause injury by contacting with the driving unit of the analyzer 2 Remove the cover Remove the top cover by sliding it to the left SP 4430 4 13 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE Remove the side cover 3 Remove the Nozzle Tube Remove the Nozzle Tube from the Nozzle using tweezers NOTE Do NOT scratch or damage the Noz
17. and setting it on the Centrifuge equipped Multi Rack the operation centrifugation suction sampling is conducted automatically This saves centrifugation of whole blood samples before measurement Calibration using magnetic cards Reagent Card are provided with the Reagent Strips is possible without using the SPOTCHEM Calibrator Kit By inserting magnetic cards into the magnetic card reader differences between reagent strip lot number and daily deviations are automatically calibrated Optional Hand held Bar Code Reader is available By reading the bar code of each sample the bar code is automatically allocated as patient ID With the optional Data Management Software and external devices remote control of measurement results and remote update of parameter settings are possible SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION 1 1 2 Measurement principles The light emitted from LED becomes monochromatic light of a certain wavelength after passing through an optical fiber Five different types of optical filters are provided and the optimum wavelength is selected for each test item Monochromatic light is separated and transmitted to the photometry section of each channel by ten optical fibers Photom et y section Light sou LED Cpucal filter Monochromatic light of 5 types certain wavelength In each photometry section the monochromatic light transmitted b
18. displayed To restore the MAIN MENU press STOP key When ENTER key is pressed the Table Cover opens and the Standby screen is restored 2 20 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 4 Set measurement No or ID if necessary ID of up to 13 characters can be set for each measurement If ID setting is not necessary move on to procedure 6 Rack slides forward The Standby screen is displayed as shown at the right Press 1 key on the Standby screen The measurement No screen is displayed Enter measurement No Up to 4 characters can be entered using numbers Press ENTER key The entered measurement No is stored in memory and the ID entering screen is displayed Enter ID Up to 13 characters can be entered using numbers letters and symbols When the barcode reader is used ID is automatically read by the reader Press ENTER key The entered ID is stored in memory and the Standby screen is restored Standby 000000000 INFQ 1005 0 Cover is closing Stop 5 Back to MENU 5 Back to MEAS SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT p gt No set up is available where 5 Set the sample type when necessary sample type is not registered The registration can be made on Sample type can be set for each measurement
19. key three times to return to pore Submenu the MAIN MENU Calibrate 00000 3 16 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU 3 3 3 pe Besides hyphen key 0 2 4 5 6 and 8 keys can be used in selecting items 0 gt initially displayed item 2 gt last item 4 gt previous item 6 gt next item 8 gt first item 5 gt first item of the M ulti Reagent Strip pe If ALL SINGLE or ALL MULTI is selected parameter settings of all the items for Single or Multi Regent Strips are printed out respectively Initialize parameters Initialize parameter settings to the factory setting values 1 Display setting screen e Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed e Press 2 key The PARAMETER MENU 1 2 is displayed e Press 3 key The Password entering screen is displayed Enter password 99 15 displayed e Press ENTER key The Measurement item selecting screen is restored N Initialize parameters e Press hyphen key to select a measurement item to initialize e Press ENTER key The Initialize confirmation screen is displayed e Press START key or STOP key If START key is pressed parameters are initialized and the Measurement item selecting screen is restored If STOP key is pressed initialization is canceled and the Measu
20. screen Be sure to enter correct dates to avoid inconsistencies The 2 digit number of the year section of the date indicates the last 2 digits of year and is interpreted as follows 00 89 gt 2000 2089 90 99 gt 1990 1999 See 3 09 page for information on wildcards If the selected measurement result is not found in the data No matching data is displayed as shown on the right Press ENTER key to return to the Measurement result selecting screen SPOTCHEM EZ SP 4430 OPE RATING MANUAL 3 Enter search condition Enter the dates of starting and finishing measurements by sliding the cursor using hyphen key Press ENTER key The ID entering screen is displayed Press ENTER key when not searched by ID Enter an ID search pattern for the sample s to print by using numbers alphabets and symbols up to 13 characters Wildcards can be used to enter Press ENTER key The selected measurement results are printed out When the printing is completed the Measurement result selecting screen is restored 4 End printing e Press STOP key three times to return to the MAIN MENU DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Printingjpl 0000 00 stop 5 Latest Search D OUUU No data matched ENTER Measure Submenu Calibrate D agg
21. 03 02 Chapter 2 MEASUREMENT Insert a card The same stripe Inseart a card The same stripe Inseart a card Cal Another stripe Inseart a card Cal CAL CARD J Cover is closing Stop STOP Back to MENU 5 Back to CAL ENTER Standby LOO HOO NOO SP 4430 2 33 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT When performing 1 point 5 Set the Tip calibration High proceed to procedure 9 e Set the tips in the tip hole of the Centrifuge equipped Multi Rack using tweezers IMPORTANT Do NOT touch the end of the Tip with bear hands If the tips are soiled correct sampling may not be done and this will lead to incorrect calibration results e Make sure that the Tip Waste Case is set in position 6 Set the calibrator Low Remove the caps and set the calibrator Low to the port of the Centrifuge equipped Multi Rack NOTE Be sure to remove the caps before calibration to avoid damage to the nozzle NOTE Make sure that the protective cover If the protective cover remains is closed before the measurement open it may cause a trouble 7 Setthe Reagent Strips IMPORTANT Be sure to insert the tip of the strip in the groove of the reagent table so that the Reagent
22. 1 77287 HDL C Kit 50 1 77288 FRA 50 1 77289 IP 50 1 77298 Mg 50 1 77299 HDL C 50 1 77239 MMulti Reagent Strips SPOTCHEM II Multi Item Specifications Qty Product code Liver 50 1 77290 Stat 1 50 1 77291 Panel 1 50 1 77292 Panel 2 50 1 77293 Heart 2 50 1 77294 Kidney 2 50 1 77296 Multi V 25 1 77364 84 00143A
23. 19 DOC No OM 28573 REV 6 03 02 p gt The number of the previous measurement No 1 is displayed as the initial number To perform measurement with the number press ENTER key to confirm Once the power is turned off the initial number returns to 1 The last entered ID is displayed To perform measurement with the same ID as shown on the screen press ENTER key If the MAIN MENU is restored the previous ID is cleared To enter ID use the numeric keys and key Example To enter EZ 3 3 3 9 9 9 9 9 Example To enter SP 7 717 7 7 E1071 The following 12 signs can be entered by using 0 key To delete the last character press MENU key and key simultaneously To restore the initially shown ID press START key When the barcode reader optional is used manual entering is not necessary Read barcode is automatically allocated as ID When the barcode reader is used a message BARCODE AVAILABLE is displayed Press hyphen key on the Standby screen to switch the operation guidance at the lower part of the screen If no key entry is made within 3 minutes after the Table Cover is opened an alarm beeps and the Table Cover is closed If STOP key is pressed while the message CANCEL is displayed the Table Cover remains open and the Standby screen is restored After the Table Cover is closed a message shown at the right is
24. 5 10000 to 10000 can be entered Press ENTER key The Calibration p gt When the wrong key is pressed ye f press the MENU key and conditions setting screen is key simultaneously to delete the displayed last entered character p gt START key is pressed the 5 Set calibration conditions initially displayed value is restored e Select Cal or CARD by pressing hyphen key Cal Calibration by Calibrator N 000 CARD Calibration by magnetic card 3 14 SP 4430 pe Mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range p gt the standard range entering screen a sample type is displayed p gt When the sample type are set only up to two the standard range entry for the sample types 3 to 5 will be omitted SPOTCHEM EZ SP 4430 OPERATING MANUAL e Press ENTER key The cursor moves to the entry position for the number of times of calibration Any number from 2 to 6 times can be entered e Press ENTER key The Standard range setting screen is displayed Set the standard range E When sample type is not set e Enter the lower limit of the standard range with the numeric keys e Press Enter key The cursor moves to th
25. 9600bps Suppression by CFT and RTS are possible Suppression is not set by default XON XOFF control is not available 2 second waiting time is inserted between each block from lt ETX gt or lt ETB gt to lt STX gt Data transmission is sometimes forced to stop halfway by key operation It is not promptly stopped by pressing a key but transmission continues until lt gt lt ETB gt is output SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 6 APPENDIX 6 1 2 Format Block structure is regular One block consists of start data and end This is illustrated below in the following descriptions Start Data End Start 5 Start of each block is lt STX gt Start of block is expressed as S in the following illustrations e Data Data text of each block is the main body of transmission contents and is expressed by arrangement of ASCII characters CR gt lt LF gt RS gt or lt US gt is sometimes involved in data Characters other than these cannot be involved End End of each block is lt RTX gt or lt ETB gt ETX or ETB gt is distinguished by whether it is in the last block or not If itis in the last block it is lt ETX gt and if it is in the middle block it is lt ETB gt The block end is expressed by E in the following illustrations SP 4430 6 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Ch
26. Analyzer 1 4 1 Cautions 1 4 2 Setting up the analyzer 1 4 3 First operation after setting up 1 4 4 Notes attransportation SP 4430 1 01 DOC No OM 28573 REV 6 03 02 1 1 Outline SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION 1 1 1 1 02 6 SP 4430 Features Compact and lightweight design m Energy saving design m Automatic Sampling mw Built in centrifuge for 1 sample E Simple calibration using magnetic cards m Sample Control by Bar code E Online Network through two way Transmission The footprint of the SP 4430 is as small as that of a notebook computer It weighs only 5 kg and can be easily carried by one person The small unit contains various components such as a display printer 1 sample centrifuge and automatic tip disposal mechanism No water supply or drainage system is required therefore it is suitable for examinations in schools or bedside in hospitals Power consumption is greatly reduced Power consumption per 1 hour is approximately 50 W on average AC 100V 60Hz when continuous measurements are conducted The analyzer automatically absorbs samples set on the Centrifuge equipped Multi Rack and drops them on reagent strips Manual operation is not necessary so that the sampling amount becomes constant and stable measurement results can be obtained The analyzer has a built in centrifuge for 1 sample By placing the whole blood sample in the centrifuge tube
27. EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 5 3 Calibration by calibrator kit Use the SPOTCHEM Calibrator Kit for calibration For Hb items use the SPOTCHEM Calibrator Hb Kit Ja WARNI NG Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste Be careful not to spill sample blood when uncapping the tube 1 Set the calibration type by calibrator kit When changing the calibration type from calibration by magnetic card CARD to the calibration by calibrator kit Cal change the setting by referring to see 3 3 2 Enter parameters If the calibration type is already set for calibrator kit this operation is not necessary 2 Display the calibration menu pe CARD means calibration by e Press 3 key on the MAIN MENU ic calibration card and dv CALIBRATION MENU is displayed Measure Submenu D Calibrate 00000 calibrator kit P Cali CARD Information 0000 3 Prepare the reagent strip and calibrator Prepare the required amount of Reagent Strips according to the following table p gt When performing the calibration by calibrator kit using Multi Reagent Strips calibration mode of each measurement item single item a
28. J WARNING pe The required volume of a serum or plasma sample is 6x number of test items 38 1 example the required volume for 5 test items is 6x5 38 68 p gt A Serum or Whole blood Sample Tube has 2 lines marked on it for 100 1 and 500 80034 100 IMPORTANT p gt The Whole blood Sample Tube contains heparin as an anticoagulant Prepare samples as described below except for Hb and HDL C which require different procedures see pages 2 16 and 2 17 for sample preparation for Hb and HDL C Test items may be added or changed in the future Read the package insert of SPOTCHEM Reagent Strips carefully for details on handling samples Wear protective gloves to prevent exposure to pathogenic microbes pl s Tube Required sam ple amo uni Serum sam ple tube Blue cap X rum ber d test kane 32 Whole blood Whoe b ood sanp Traage 25001 Whole blood Centrifuge tube 250 UL Serum or plasma sample Prepare a Serum Sample Tube blue cap Blue cap Pipette serum or plasma If measurement is not performed immediately cap the tube to prevent Serum sample tube contamination or evaporation Remove any air bubbles or skin on the surface of the sample They may cause incorrect measurement results Whole blood Prepare a Whole blood Sample Tube Orange cap orange cap Uncap the tube and pipette wh
29. STOP key is pressed during operation the setting is canceled and the date setting is restored Forthe time settings only the hour and minute can be set The cursor does not move to the second position Set the Date and time of the built in clock Once the date and time are set resetting is not necessary However resetting may be necessary in a long time of use 1 Display setting screen e Press 2 key on the MAIN MENU SUB MENU1 2 is displayed Measure 5 Calibrate 0000 Results PARAM j Maintenance 0000 e Press MENU key key SUB MENU 2 2 is displayed Mode Clock UUUUU Press 5 key The Password entering screen is Password displayed Enter password 99 Cancel 5 xis displayed on the screen Press ENTER key The Clock adjustment screen is displayed 2 Set the date and time Enter the present date by sliding the cursor with hyphen key e Press ENTER key The cursor moves to the time entry position e Enter the present time by sliding the cursor with hyphen key e Press ENTER key The set date and time are stored and the SUB MENU 2 2 is restored 3 End Setting e Press STOP key to return to the MAIN MENU
30. Select Yes from the Yes No option STOP Stops measurement Select No from the Yes No option Cancels entry FEED Feeds the built in printer with paper while pressed MENU Switches the page on each menu display 0 9 ten key Selects the menu number Enter numerical values and ID Selects item move cursor switch the page on the display and enter minus sign and decimal point ENTER Determines the entry Check message to proceed to the operation SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION 1 3 3 Rear of the analyzer mal 1 Power switch 3 Fan 5 BCR T Paper holder BU Pore input terminal 4 COM gt NO Item Function 1 Power switch For turning on and off the power supply to the analyzer 2 Power input terminal For the supplied AC adapter 3 Cooling Fan For Ventilating heated air in the unit to prevent overheating 4 COM For the cable of the optional external device 5 B C R J ack for the bar code reader option 6 CONT For adjusting screen contrast Turning clockwise to make the screen darker counterclockwise makes it brighter 7 Paper holder For setting thermal printer paper SP 4430 0 1 09 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 1 4 Setting up the Analyzer 1 4 1 Cautions Chapter 1 I
31. Survey Mode is canceled Switch to the Survey Mode When measurement is performed in the automatically when the power is Survey Mode raw data as well as normal measurement results can be printed out see 2 6 Interpreting measurement results for details of printouts 1 Display setting screen Press 2 key on the MAIN MENU SUB MENU1 2 is displayed Calibrate Results PARAM Maintenance 0000 e Press MENU key or key SUB MENU 2 2 is displayed Press 4 key 5 The MODE MENU is displayed Press 1 key The Survey mode setting screen is displayed Survey OFF 2 Switch to the Survey Mode e Press hyphen key Turn ON the Survey Mode Survey OND Press ENTER key The message Writing is Writi displayed and the MODE MENU is ritingjgp restored 3 End the Survey Mode e f the setting is finished press Measure j Submenu STOP key three times to return to i the MAIN MENU Calibrate 00000 3 24 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 3 6 Built in Clock Adjustment rs If STOP key is pressed during operation the setting is canceled and the SUB MENU 2 2 is restored If START key is pressed the initially displayed value is restored If
32. Waste Case and Protective Cover The Tip Waste Case holds used tips Its capacity is for 5 measurements Discard used tips and wash the Waste Case Clean the Protective Cover if necessary 3 A message suggesting the disposal of used tips is displayed every 5 measurements Alcohol Cloth and Protective gloves AA WARNI NG Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective gloves separately fr waste according to local regulations on biohazardous waste 1 Slide the Centrifuge equipped Multi Rack forward Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Submenu Calibrate Press 3 general The Table Cover opens and the Results PARAM Reagent Table and the Centrifuge equipped Multi Rack slide forward Ready Turn OFF the power Please turn off 2 Discard Tips Remove the Tip Waste Case from the Centrifuge equipped Multi Rack e Discard tips 4 06 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE 3 Disinfect and wash the Tip Waste Case Disinfect the Tip Waste Case with alcohol and wash it with tap water Wipe it dry with a cloth 4 Reattach the Tip Waste Case Put the T
33. When sample type is not the Parameter Menu registered or measurement is made on the setting of basic type skip the following p gt sample type set for basic and proceed to the Step 6 type is established as an initial value No setting is needed Press 6 key on the Standby screen when not changed The Sample type selecting screen is Standby 0000000000 displayed INFO 00 We Besides hyphen 4 Press hyphen key to select the and 6 keys can be used in sample type BESTE Standby 0000000000 selecting sample type 4 previous sample type 000000 0000 6 gt next sample type e Press Enter key while the selected p gt Pressing Start key on the sample type is displayed Sample type selecting screen starts measurement with the displayed sample type without e The selected sample type is set as returning to the Standby screen Standby 0000000000 1D 00 INFOQ OO the measurement sample type and the Standby screen is restored 6 Set the Tip Place the Tip in the Tip hole of the Centrifuge equipped Multi Rack using a pair of tweezers IMPORTANT Do NOT touch the pointed end of the Tip with fingers If it is soiled correct measurement results may not be obtained Make sure that the Tip Waste Case is set in position SP 4430 2 21 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MA
34. and tips The centrifuge for 1 sample is built in 3 Port For setting the samples 4 Centrifuge For setting the whole blood samples that have not been centrifuged 5 Tip hole For setting tips 6 Tip waste case The container for used tips automatically discarded after sampling Filled with 5 measurements 7 Black amp white plates The standard reflection plates used for measurement of reflectivity 8 Table cover Prevents entering the external light Slide forward the Reagent Table and Centrifuge equipped Multi Rack to open 9 Operator panel For starting or stopping measurement and entering IDs 10 Display Displays information such as operating state of the unit and error messages 11 Magnetic card reader For inserting magnetic cards Reagent Card and Calibration Cards 12 Built in printer Thermal type printer Prints out measurement results and setting conditions 13 Maintenance cover Protects the Nozzle Driving Units Also prevents the operator from contacting the nozzle during measurement There are top and side covers 14 Protective cover Prevents the operator from contacting the Centrifuge Tube Also protects spilling of samples SP 4430 1 07 DOC No OM 28573 REV 6 03 02 1 3 2 1 08 6 SP 4430 Operator panel SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION ur Ten Bm 90 mr 1 ae Be em On 7 Item Function START Starts measurement
35. error occurs an alarm sounds and the error message appears 577 1 The following errors are not on the screen printed when the magnetic The error message is automatically printed in order to preserve the cardis inserted error record The following errors are only displayed and not printed ES hi 1 E24 Wrong card E25 Wrong stripe Description and error message Conditions and causes Remedy The table cover was opened during Close the table cover correctly 02 measurement or warm up Remove the foreign matter The maintenance cover was opened e Set the maintenance cover in the 000 00000 0000 during measurement or warm up correct position The table cover is not properly closed T Trouble with the table cover Foreign matter is jammed Trouble with the maintenance cover The measurement was started without closing the maintenance cover e Power failure has occurred during e The last measurement was invalid E03 measurement Restart measurement Power was turned off during 000 00000 0000 measurement 000000000 e The power cable was unplugged during measurement A light source is deteriorated f the same trouble occurs contact 04 your distributor 000 000 00000000 000000000 The white and black plate window Clean the white and black plate or 05 plate
36. gt To stop printing press STOP key Printing stops and the Measurement item selecting screen is restored 3 End Printing ePress STOP key to return to the MAIN MENU Measure j Submenu Calibrate 0000 3 10 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL p gt lot number and calibration date are printed only when calibration by calibrator kit was performed A Mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range w mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Parameters can be printed by executing Printing parameters The formats are slightly different between Single Reagent Strips and Multi Reagent Strips 1 Printing of single parameters SP 4430 00 Paraneter 5 01 AASFO4 2001 11 26 T o 9 Galibration CARD Cal Acal 1 000 Beal 0 000 _ _ ____ L amp H 2 ABCDEF 2000 06 02 CARD Asys 1 051 Bsys 2 125 o Temperature conversion 37 C Correlation correction Acor 1 000 Boor 0 000 o Range Limit io 1500 Normal men 10 80 Woman 10 60 E 1 Version 2000 06 04 17 29 2 Printed date and time The date and time when printing of parameters is executed
37. is dirty window plate see 4 2 1 Cleaning the Reagent Table and 4 3 2 00 0000000 00000 Cleaning the Optical Window 0 D 000000000 W 2 AA WARNI NG protective gloves in order to avoid exposure 10 9 Channels with abnormalities to pathogenic microbes Reagent Strip is not set Set Reagent Stripes correctly 1 1 The bar code was not correctly read When calibrating set the necessary due to displacement or bending of the numbers 000 00 000000 Reagent Strip 000000000 The Reagent Strip is not set the 7 9 Single type Multi type channel necessary for calibration Channel with no Reagent Strip in either F Display is ata only in taba Usually l WARNING Wear protective gloves in order to avoid exposure nothing is displayed during measurement to pathogenic microbes 5 02 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 5 TROUBLESHOOTING Description and error message Conditions and causes Remedy E13 000000 U0 000000000 70 9 Single type Multi type Channel with a different Reagent Strip either case When calibrating by calibrator kit a many Reagent Strip is set The bar code was not correctly read due to displacement or bending of the Reagent Strip Before calibration of an item is completed another item was attempt
38. results obtained by this device to match the results by another measurement method reference method Apply the regression equation Y aX b X measurement result of the SP 4430 Y the result obtained by the reference method Enter coefficient values for a and b For obtaining the coefficients of correlation correction for a and b contact your distributor mStandard range When the measurement results are printed A or w standard range When sample type is set its corresponding standard range is applied alibration Conditions Set the type calibrator or magnetic card and the number of times of calibration for each measurement item n Is added on data out of the 1 Display setting screen Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Submenu Calibrate Results PARAM jj Maintenance 0000 Press 2 key The PARAMETER MENU 1 2 is displayed Print Input lnitialyze D Hg e Press 2 key and the Password entering screen is displayed Password _ Cancel STOP Enter password 99 Press ENTER key The Measurement item selecting screen is displayed SP 4430 6 3 13 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 2 Select measurement items p gt Besides hyphen key 0 2 Se
39. starting with hyphen key by entering the attempt will fail A searching pattern with more than four asterisks cannot be entered SP 4430 3 09 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 3 3 Parameter Menu 3 3 1 Print parameters Chapter 3 SUB MENU Print the present parameter settings by each measurement item for checking 1 Display setting screen Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure csubmenu Calibrate 00000 Results PARAM j Maintenance 00000 Press 2 key PARAMETER MENU 1 2 is GN Input displayed Initialyze 0000 2 Print parameter settings Press 1 key The Measurement item selecting screen is displayed p gt Besides hyphen J key 01 21 Select measurement items to print 4 5 6 and 8 keys can be r used in selecting items by pressing hyphen key 0 gt initially displayed item 2 gt last item 4 gt previous item e Press ENTER key 6 gt next item Printing starts After printing is 8 gt first item 5 gt first item of the Multi completed the Measurement item Reagent Strip selecting screen is restored p gt f ALL SINGLE or ALL MULTI is selected parameter settings of all the items for Single or Multi Regent Strips are printed out respectively p
40. stored in the memory 3 SEARCH The measurement results searched by the date range and or ID 1 Display setting screen e Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Me supmenu DD D Results PARAM 0000 Press 1 key The MEASUREMENT RESULTS Print Send MENU is displayed Delete 00000 2 Select measurement results to print Press 1 key Latest Search 000 D The Measurement result selecting screen is displayed Select the measurement results to print by using the numeric keys 1 LATEST the latest measurement result 1 measurement 2 ALL all measurement results 3 SEARCH the searched measurement results by date and ID When LATEST or ALL is selected Printing starts immediately After printing is completed the Measurement result selecting screen is restored e When SEARCH is selected The display proceeds to step 3 pe If the selected measurement is not found in the data No matching data is displayed as No data matched shown on the right Press ENTER key to return to OK E NT E R the Measurement Results selecting screen 3 04 SP 4430 If designation of the range of measurement dates the dates of starting finishing measurements is unnecessary press ENTER key twice to proceed to the next setting
41. such as PC is incorrect Connect the cable correctly Confirm the setting e g baud rate of analyzer connections e g PC 000000000 000 000000 0000 7 4 1 000000000 00 Channels with abnormalities Failed to draw the sample and drop it to the reagent correctly due to lack of sample amount or absorbing fibrin Failed to drop the sample to the reagent correctly because the sample adheres around the dropping hole Check the sample amount and remove fibrin if necessary Wipe off the sample adhered to around the dropping hole Measure it with a different tip E90 00000000000000 The memory storing the measured results is defective Power was cut while writing in memory or deleting the same trouble occurs often contact your distributor LU ag ag gag 000 000 0 The memory storing the trouble history is detective Power was cut while writing in memory or deleting If the same trouble occurs often contact your distributor Ug ag gag 000 00 Lg a HU D e The memory storing the setup data is defective Power was cut while writing in memory or deleting e If the same trouble occurs often contact your distributor s the user setting value is initialized or is returned to the last measured value reset it re enter it 5 06
42. the wrench Attach a new Nozzle and fasten it lightly by hand Tighten it firmly using two wrenches SP 4430 6 4 17 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 5 Reattach the Tip Waste Case Put the Tip Waste Case by tightening the screws 6 Reattach the covers Put the side cover to the analyzer Put the top cover to the analyzer by sliding it to the right 7 End replacement NOTE Before turning ON the power make sure that the maintenance cover is installed Turn ON the power Warm up starts The Reagent Table Warming upnnp and Centrifuge equipped Multi Rack slide back to the original position and the Table Cover closes When the operation is completed turn OFF the power after the MAIN Measure Submenu MENU is displayed Calibrate 00000 4 18 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 5 TROUBLESHOOTING When there is a failure in operation or a problem with the analyzer an error or trouble occurs This chapter describes the kinds of errors troubles causes and remedy 5 1 Error Messages 5 2 Trouble Messages 5 3 After sales service SP 4430 5 01 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 5 l Error Messages Chapter 5 TROUBLESHOOTING When an
43. to measure standard values of reflectivity measurement Be careful not to leave grease or scratch the plates by touching them with bare hands Otherwise correct measurement results may not be obtained e Requirements soft cloth cloth for eyeglasses is preferable e Carefully wipe out stains or dust adhered to the black and white plates with a soft cloth e Do NOT try to blow dust away with your breath which may cause fogging of the plates Use a soft cloth a brush or a camera blower 3 Clean the Rubber Plate Once a week Remove the top cover by sliding it to the left SPOTCHEM EZ SP 4430 OPERATING MANUAL Moisten a cotton swab with distilled water and wipe out stains or dust adhered to the Rubber Plate If the Rubber Plate is wet use a dry cotton swab Attach the top cover by sliding to the right End cleaning Turn ON the power Warm up starts and the Reagent Table and the Centrifuge equipped Multi Rack slide back to the original position and the Table Cover closes If the operation is completed turn OFF the power after the MAIN MENU is displayed DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE Warming upgpo Measure Submenu Calibrate 0000 4430 4 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 4 2 2 Cleaning the Tip
44. 0 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU MEASUREMENT RESULTS 1 Print Prink reae ramani skera in Bua Print of Search by date md in amallab Fae posa Trane renun in fe in the sT by and E is aae HEHU eT Print z SS 1 MT or HT uni Tian h ug EE TM E Hai iha of rsiibratian Cal CARD anl ibm rumba of culmine the miling oia for anch Burn jDewipkn o esaet MN S C 0 1 6 Fafarerue Lam survey secnm eset tura SP 4430 0 3 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 3 2 Measurement Results Menu 3 2 1 Print measurement results Chapter 3 SUB MENU pe lf STOP key is pressed during Print measurement results stored in the memory Max 100 measurements operation the previous screen x x e f The following three options for printing are available is restored 1 LATEST The latest measurement result one measurement ee In case of reprinting 2 ALL All measurement results Max 100 measurements measurement results are printed starting from the latest result
45. 045 154 same repetition as 022 044 When the number of items is less than the redundancy makes up forthe blank 20H e el ce 8 SP 4430 6 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 6 APPENDIX e Format of Single Reagent ida measurement results eos e per pesos eom e os ao oco oss oon ne pe on ne raez oes pes uza oT oe urs o7a u7s oe n77 07e 7a nec uer use oss aeaes aee 087 088 When only Single Reagent Strips are measured Blank 20H When Reagent Strips are measured Fined character string SINGLE 29 Abroma al m a MW thin the range of standard values Blank 20H a Low value lt US gt 1FH High value lt AS 1EH co w42 Temperature Blank 20H ltem s other than enzyme Blank 045 The same repetition as 0237044 extra output is made The black length of this block changes according to the number of Reagent Strips items For example if tha number of the Reagent Ships are 2 2 items the block length is completed as Bb bytes
46. 3 From the left item name item symbol lot number and expiry date 4 Calibration type CARD means calibration by magnetic card and Cal means calibration by calibrator kit 5 Calibration factor 6 From the left calibration mode L amp H L the number of calibration times lot number and calibration date 7 Coefficient of system s difference correction Coefficient to use in the measurement calculates 8 Temperature Printed out as for the items other than enzyme items 9 Coefficient of correlation correction Coefficient set in the Entering parameters in the SUB MENU 10 Measurement range The lower limit and upper limit 11 Standard range The lower limit and upper limit 12 Sample types The lower limit and upper limit of standard range for each sample types set Printing is available only when sample type is set 5 4430 3 11 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU gt The lot number and calibration date are printed only when calibration by calibrator kit was performed 3 12 SP 4430 2 Printing of multi parameters SP 4430 1 00 2000 06 05 07 22 Parameter STAT 1 03 09005 2001 12 02 Calibration CARD Cal n 2 ABODEF 2000 06 08 BUN 8 08 1 the left name of Multi Reagent Strip item symbol lot number and expiry date 2 Calibration type CARD means calibration by magnetic c
47. 3 characters Wildcards can be used to enter Press ENTER key The selected measurement results are transmitted When the transmission is completed the Measurement result selecting screen is restored 4 End transmission e Press STOP key three times to return to the MAIN MENU DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Sending 0 000000 stop 5 Latest Search No data matched ENTER Measure 5 Calibrate D agg SP 4430 3 07 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 3 2 3 Delete measurement results Delete all the measurement results stored in memory 1 Display setting screen Press 2 key on the MAIN MENU SUB MENU1 2 is displayed Measure j Submenu Calibrate 0000 Results PARAM 00000 Press 1 key The MEASUREMENT RESULTS Print Send MENU is displayed Delete 00000 2 Delete measurement results Press 3 key The Password Password Cancel 5 entering screen is displayed Enter password 99 displayed on the screen e The Delete confirmation screen is Delete Yes START 5 displayed Press START or STOP If START key is pressed the me
48. ATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 Calibration Result of Multi Reagent Strip G SP 4430 V1 0D 2000 06 03 12 34 Results of calibration PAMEL 1 M 04 MD9DO4 2001 03 10 Calibrator ABCOEF Glu 3 2 Data LO 75 000 HO 300 000 74 250 1 298 050 LI2 13 650 2 287 123 Mean L 13 594 291 840 Acal 1 021 Bcal 0 871 From the left name of Multi Reagent Strip item symbol lot number and expiry date 2 From the left item name and item symbol For the items when calibration mode is L the H part is blank For the items when calibration mode is H the L part is blank SP 4430 2 43 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL MEMO 2 44 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU With the SUB MENU auxiliary operations other than normal measurement and calibration can be performed This chapter describes the SUB MENU functions and operating procedure 3 1 Overview of SUB MENU 3 1 1 Composition of SUB MENU 3 2 Measurement Results Menu 3 2 1 Print measurement results 3 2 2 Transmit measurement results 3 2 3 Delete measurement results 3 3 Parameter Menu 3 3 1 Print parameters 3 3 2 Enter parameters 3 3 3 Initialize paramete
49. EMENT 2 2 2 Handling samples Wear protective gloves eBlood is used as a measurement sample with this analyzer Be aware that blood may be contaminated with pathogenic microbes that may cause infectious disease Exercise utmost care whenever handling blood Incorrect or imprecise procedures may result in exposure to pathogenic microbes eHandling samples slightly differs depending on test items Follow the instructions on the package insert of SPOTCHEM Reagent Strips 2 2 3 Handling Reagent Strips j eau Lot Aes NOT use expired Reagent Strips or deteriorated strips of which the reagent fields show any sign of discoloration or deformation even if they are before the expiration date Correct measurement results may not be obtained e Take Reagent Strips out of the refrigerator 20 minutes before measurement and allow them to reach room temperature 10 to 30 Otherwise correct measurement results may not be obtained eDo NOT touch the reagent field on the strip with fingers Sebum on the reagent field may result in incorrect measurement results eWhen a new reagent strip box is opened perform calibration by magnetic card using the supplied Reagent Card see 2 5 2 e Open a reagent strip package immediately before use If the opened reagent strip is left for a while it will absorb water from the air or g
50. ENT SPOTCHEMII Reagent Strips optional must be used with this analyzer There are two types of SPOTCHEM Reagent Strips Use the correct type of strips for the measurement purpose e Multi Reagent Strip A Multi Reagent Strip has 5 6 reagent fields for analyzing various items including normal screening and liver or renal function screening Barcode name 12010 kuki Reagent Strap e Single Reagent Strip A Single Reagent Strip has only one reagent field on it Several different reagent items of Single Reagent Strips can be measured for one sample Barcode hem name s Single Reagent Sirs 2 02 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 1 2 Normal measurement In normal measurement more than one item can be measured at a time for one sample The Reagent Strip Table can hold three Single Reagent Strips and one Multi Reagent Strip so that simultaneous measurement of up to nine items is available The operating procedure of normal measurement is described as shown below Pipini he whae hood samples and place in he centrifuge tuba he and paara ened pica tham is conair Than iha armani Us Carroll Mull Pic Prepare the zamples in zocordianoa mith the instructions attached the Reagent Strip m 5 When ihe In co
51. EV 6 03 02 Chapter 1 INTRODUCTION A CAUTION Before setting up the analyzer read the following notes and always take proper safety precautions eDo NOT set up the analyzer where chemicals are stored nearby or where corrosive gases or electrical noise are generated They may damage the analyzer and malfunctions and or injury may occur Correct measurement results may not be obtained e Avoid exposing the analyzer to direct sunlight condensation and wind Otherwise correct measurement results may not be obtained and may cause deformation or malfunction of the analyzer eTo connect the analyzer to external devices be sure to use proper cables to avoid electric shock and or fire For details contact your distributor ePlace the analyzer in a room at temperatures between 10 C 30 with humidity between 20 and 80 Otherwise correct measurement results may not be obtained e Make sure that the room is well ventilated when a large amount of carbon dioxide is generated when gas Stoves oil heaters and instantaneous water heaters are used in the room This is because the pH of the Reagent Strips which use an alkaline reaction reagent decreases under the influence of carbon dioxide and correct measurement data may not be obtained Be careful not be put hands under analyzer
52. G MANUAL Chapter 2 MEASUREMENT p gt Press STOP key to stop the calibration the Calibration standby screen is restored 2 36 SP 4430 8 Start measurement of the Low calibrator e Press START key The Reagent Table and Centrifuge equipped Multi Rack move inside and the Table Cover Measuringgpng Stop 5 closes Measuring is displayed Approximate remaining time is displayed The time displayed in Measuringgpng 00000 0 Stop 5 changes at every 30 seconds As the measurement proceeds the display of approximate remaining time changes to the ordinary time Measuringjjj7 00000 indication The disappears and Stop 5 the time is counted down by one second When Low calibration is completed the Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack move forward The Calibration standby screen is displayed When the number of calibration is more than 3 repeat the procedure from 5 to 8 The Calibration standby screen displays the name of the Reagent Strip being calibrated the measured number of Low and High L H and the calibration times N The cursor blinks at L or H according the calibrator Low or High to be calibrated next The examples of the Standby screen at the right shows the number of times of calibration is 2 Low has already mea
53. LIBRATION calibration by magnetic card Insert a card MENU 5 e Insert a strip of Reagent Card in the p gt There is no order for inserting magnetic reader and slide the strip the stripes Either stripe can be 3 inserted first to the right Cc J COS COCOCOCI e SP 4430 2 29 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT e When the stripe is inserted the Insert a card The same stripe screen shown at the right is displayed e Insert the same stripe according the message on the screen When the same stripe is inserted Insert a card Sj twice item number is displayed Another stripe The inserted stripe number is displayed with the lower right p gt Insert the same stripes twice to screen read the stored information in the magnetic cards e Insert the remaining stripes twice t rd according to the message on the Insert a card 5000 GGT T XXXXXX screen When all stripes are inserted measurement item and lot numbers are displayed e About 2 seconds after the Magnetic card entry screen will be displayed Calibration by magnetic card is completed 4 End of calibration by magnetic card When the discontinuing the Measure 5 calibration press STOP key 3 times to return to the MAIN MENU Calibrate 0000 2 30 SP 4430 SPOTCHEM
54. MANUFACTURED HY ARKRAY Inc 83 00140F Printed in Japan SPOTCHEM EZ SP 4430 Operating Manual DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Premise This manual contains important information on the functions of the SPOTCHEM EZ SP 4430 Distributed A Menarini I F R srl Diagnostics Division This manual is issued by ARKRAY Inc Read carefully prior to starting up the unit It is recommended to retain this manual for future use This product conforms to European Directive 98 79 EC 01 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Introduction The SP 4430 is an automated biochemical analyzer using a dry chemistry system This manual contains outlines instructions for the operation maintenance and troubleshooting for the SPOTCHEM SP 4430 Before operating the SP 4430 read this manual carefully It is recommended to retain this manual for future use AA WARNING e Always be careful when handling blood samples or waste reagent strips Incorrect or imprecise procedures may result in exposure to pathogenic microbes e This analyzer must only be operated by those trained in proper procedures for clinical testing and handling of hazardous waste Anyone who operates the analyzer for the first time must be assisted by a trained person Never touch the Reagent Table Centrifuge
55. NTRODUCTION A CAUTION Eee Before setting up the analyzer read the following notes and always take proper safety precautions e Allow a space of 10 cm or more between e Operate the analyzer with power of the the rear of the analyzer and the wall correct voltage and frequency Failure to do so may cause overheating Otherwise fire or damage may result Excessive load on the cable connection may cause fire or incorrect measurement results e avoid electric shock and or fire use e Connect the power plug directly to an the attached power cord to connect with outlet not via an extension cord or a power outlet For details contact your power tap The power supply for the distributer analyzer is 100 VA Before turning on the power switch make sure that the total input of devices connected to a receptacle of the same circuit doesn t exceed 1500 VA 100V 15 NOT unnecessarily disassemble or e Place the analyzer on a stable and level modify the analyzer Such actions may surface free of vibration Failure to do so invite danger of exposure to pathogenic may damage the analyzer correct microbes and cause fire or damage measurement results may not be obtained and injury may result Do NOT place the analyzer where there is a risk of falling 1 10 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 R
56. NUAL Chapter 2 MEASUREMENT 7 Set the samples Measurement of uncentrifuged whole blood Open the protective cover and place the uncapped centrifuge tube in position Close the cover NOTE Make sure the sample tubes are uncapped otherwise it may cause breakage of centrifuge tube and the Nozzle Set a sample after removing the NOTE sure the protective cover is closed properly If the protective cover remains open it may become troubled and correct measurement results may not be obtained E Measurement of serum or plasma or centrifuged samples Uncap sample tubes and place them to the port of the multi rack NOTE Make sure the sample tubes are uncapped otherwise it may cause breakage of the Nozzle NOTE Make sure the protective cover is closed properly If the protective cover remains open it may cause a trouble 2 22 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT IMPORTANT p gt Every time when 0 key is pressed on the Centrifugation selecting screen On and Off are displayed alternately IMPORTANT Remeasurement or additional measurement with a centrifuge When measuring the once measured sample with a centrifuge such measurement can be done ata reduced centrifugal time When performing remeasure
57. P 4430 b SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 6 APPENDIX e Format of Reagent Strip meas urement results rao ace ans ana oce oae oa pae eas ova e rs papae veu eve pe oen pe nez O22 24 025 027 028 0291030 031 Jose oss 035 Pose an 048 041 042 043 mmm mmu pas o47 045 pea ce o4 oss 066 057 058 055 260 061 062 063 224 085 058 LF foro oz1 oze urs oras o7 urs us oen uen us ues usa oss use 087 ross oes ose ose pa nes oss aa vo roe Tas Toa 08 102 10611081110 rote umm mimm c rie ns peo pre 1 rez ves vea 85 186 1e7 Tes van v8 1 132 35138 rz rs Tan 146 149 148 148 78277531754 umm mu mi m m ci eee eee Mame of Reagent Strip Abnormal m art v IN itin me range af standard values Blank 20H Low value sU High value lt AiS gt 1EH uso ues 42 Temperature 370 Blank 20H Item other than enzyme Blank
58. SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL 5 2 Trouble Messages DOC No OM 28573 REV 6 03 02 Chapter 5 TROUBLESHOOTING When a trouble occurs an alarm sounds and a trouble message is displayed The trouble message is automatically printed in order to preserve the trouble record IMPORTANT When a trouble occurs during measurement perform the measurement again It may have influenced the result obtained before the trouble occurred Perform the measurement again if the result is defective Description and trouble message Conditions and causes Remedy 000 0000 00000000 000000000 The pressure does not increase since the rubber plate is dirty or deformed The tube or pipe is clogged The tube connecting the nozzle with the pump is disconnected The tube connecting the pump with the pressure detecting sensor is disconnected Clean the rubber plate Check the tube f the same trouble occurs contact your distributor NOTE in cases where the abnormality is detected when the power switch is turned on it is necessary to turn on the power again after maintenance because the measurement could not be started 104 0000 0000000 000000000 The temperature inside the analyzer became too high because the fan had stopped The temperature outside exceeds the range 10 30 suitable for operation Confirm if the fan is rota
59. Strip stays firmly in place If the strip is placed out of the groove it may cause jam or correct measurement results may not be obtained Calibration with Single type Reagent Strips e Prepare Single type Reagent Strips When performing 2 point calibration prepare twice as many Reagent Strips as the number of times calibration that will be performed For 1 point calibration prepare the same number of times calibration that will be performed 2 34 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT e Insert the Reagent Strips with the same items starting from the S1 channel on the Reagent Table If the number of calibration is set as more than 3 for 2 point calibration calibration should be sperately performed twice In this case set 3 Reagent Strips for the first calibration ex When the number of calibration is 4 set 3 Reagent Strips for the first calibration and 1 for the second Calibration with Multi type Reagent Strips p gt With Multi type Reagent Strips e Prepare Multi type Reagent Strips 1 point calibration cannot be performed Prepare twice as many Multi type Reagent Strips as the number of the times calibration that will be performed e Setthe Strip on the Reagent Table from the right hand side SP 4430 2 35 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATIN
60. Strips without allowing them to reach room temperature may result in incorrect measurement results 2 10 SP 4430 e SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 3 2 Startup The operating procedures from turning ON the power to the MAIN MENU are described below NOTE To obtain the appropriate contrast on the screen rotate the contrast adjustment knob on the rear of the analyzer p gt Warm up time depends on the room temperature Before turning ON the power make sure that the maintenance cover is in position If light enters into the analyzer during initialization an error will occur Before turning ON the power make sure that nothing is placed in front of the Table Cover The Table Cover opens during initialization If there is an obstruction a problem may occur 1 Turn ON the power e Turn ON the power at the rear of the analyzer When the power is ON is displayed e The name of the analyzer and the system version VXXXX shown at the right are displayed and warm up starts The screen appears during warm up as shown at the right and initialization and self check of each function are performed e About 10 minutes after when at 25 C warm up is completed and the MAIN MENU is displayed SPOTCHEM EZ VXXXX Warming upgpo Measure Submenu
61. The head of magnetic card reader is dirty Insert the magnetic card again Clean the head of the magnetic card reader 000000000 00000 0000 Wrong magnetic was used calibration card was inserted when the display showed Reagent Card reading or vice versa Insert a correct magnetic card ug aguda 000 00000 000000 The same stripe was inserted Insert a different stripe Ug ag gag 000 00000000 0000 00 0000 PR Prozone error L 1 Large difference between the measured and the displayed values of calibrator L H 1 Large difference between the measured and the displayed values of calibrator H L 2 Large variations between the measured values of calibrator L H 2 Large variations between the measured values of calibrator H LH No difference between the measured value of calibrator L and that of calibrator H 10 6 Channel with an error The display is shown only in multi calibration and nothing is displayed in single calibration During calibration the difference of the measured value and the display of calibrator is extremely large The variations of the measured values are extremely large in calibration e Calibrator L and H might be set oppositely in calibration Incorrect adjustment of calibrator Perform measurement again 5 04 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MAN
62. UAL DOC No OM 28573 REV 6 03 02 Chapter 5 TROUBLESHOOTING Description and error message Conditions and causes Remedy 1 00000 000000000 The clock is not correctly adjusted The power was not connected for a long time battery is dead Readjust the date and time see 3 6 Built in Clock Adjustment 000000000 0000000 000000 0 OO 000000000 70 9 Single type M Multi type Channel with expired Reagent Strips in either case e The Reagent Strip has expired e The clock is not correctly adjusted e The clock is not correct because the power was not connected for a long time When using a Reagent Strips from new lot the corresponding magnetic card to the lot of the was not inserted e Use a new Reagent Strip e Adjust the clock e Insert a new magnetic card E33 000 00000 00000 External light entered because the table cover or maintenance cover was slightly opened Close the table cover or the maintenance cover firmly Change the direction of the analyzer 000000000 000 0000000 0 000000000 70 9 Single type Channel which was misread The table is dirty The bar code was not correctly read due to displacement or bending of the Reagent Strip Foreign matter is attached to the Single Reagent Strip AA WARNING Wear protective gloves in order to avoid expo
63. able and Centrifuge equipped Multi Rack slide backward and the Table Cover is closed The message Measuring is displayed After a while approximate remaining time is displayed The time displayed in changes at every 30 seconds Measuringnny Stop 5 Measuringnny 00000 Stop 5 SP 4430 2 25 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT As the measurement proceeds the 00000 Stop 5 display of approximate remaining time changes to the ordinary time indication The disappears and the time is counted down by one second NOTE Do NOT open the maintenance cover or the Table Cover during measurement It will cause an error 10 End measurement pe To print another sheet press 4 e When measurement is finished k the Standb ML measurement results are printed out Printi n 9n The Table Cover opens and the Reagent Strip Table and the Centrifuge equipped Multi Rack Slide forward Standby Imm ID 00 The Standby screen is restored p gt The measurement result is e Where measured results are not repeatedly scrolled printed due to lack of printer paper Standb y press 5 key on the Standby screen U UUUU to display the latest measurement
64. anges with time eliminates gaps among lots or facilities and maintains measurement accuracy to a certain level Basically calibration should be performed using the SPOTCHEM Calibrator Kit for each type of Reagent Strips but it requires a lot of time to do so for all types of Reagent Strips To eliminate such inconvenience this analyzer is designed to be able to perform calibration for different Reagent Strips by inserting magnetic cards Reagent Card storing the lot information of each reagent strip There are 2 methods for calibration with SP 4430 1 Calibration by magnetic card 2 Calibration by calibrator kit using an exclusive calibrator lit Dcalibration is performed by inserting a magnetic card Reagent Card attached to each reagent strip into the magnetic card reader calibration is performed using an exclusive calibrator This calibration should be performed every 6 months when the Reagent Lot is changed or the service representative considers that calibration is necessary The SPOTCHEM Calibrator Hb Kit is to be used for Hb items The SPOTCHEM Calibrator Kit is to be used for other items calibration There are two ways of calibration available one is 1 Point Calibration using either Low or High Calibrator Solution and the other is 2 Point Calibration using both of Low and High solution Make sure to perform calibration according to the calibration conditions of each measurement item by referring to 3 3 2 Ente
65. apter 6 APPENDIX 6 1 3 Format for measurement results format 1 The measurement result format 1 is the same as the regular format in SP 4410 or SP 4420 The receiving program designed to receive the measurement results of SP 4420 regular format can normally receive the measurement results format 1 of SP 4430 Transmission data of measurement results format 1 When transmitting the measurement results with format 1 the number of blocks differs depending on the combination of the reagent strips A When ony Multi Reagent Strips are measured Multi Fea gent Ship meas urement res Single Rea gent Strip m ea up em ent results Reagent Strip Single Rea gent Strip m ea up em ent resulbs measure ent result o0 1 004 005 004 age 2 913 914 915 pre 217018014024 o2 c eR LF 658 92405 eee eee pole m cy Description Messurement dare Year The last two digits of wear month 1712 date 11731 zero control YME form ar always applied regardlazs of the date setting og Measurement date Time 0123 Minute 01752 zero control O27 Wher ID available D iz output When there iz no D only the First 10 digits are output The measurement number expressed 4 digits without zero control Far the measurement num bar blank used for 03117036 6 04 6 S
66. ard and Cal means calibration by calibrator kit Calibration factor Coefficient of system s difference correction Coefficient to use in the measurement calculates 3 3 2 p gt If STOP key is pressed during entry the entry is canceled and the cursor returns to the previous I l or gt If the previous setting is not necessary to change press ENTER key to proceed to next L l or gt A mark is not printed when the upper limit of the standard range is the same or higher than the upper limit of the measurement range w mark is not printed when the lower limit of the standard range is the same or lower than the lower limit of the measurement range SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Enter parameters Set parameters measurement conditions for temperature coefficient of correlation correction normal value range and calibration conditions Regarding Multi type Reagent Strips setting of calibration conditions only is possible The other parameters conform to those preset for Single Reagent Strips mTemperature This device consistently performs measurements under the condition of measurement of 37 It can also convert the measurement results to those measured at 30 25 C and output the converted results However only enzyme values can be converted oefficient of correlation correction This function allows your
67. arranty is necessary when the analyzer requires repair After filling in the necessary items and confirming the described contents keep the warranty in a safe place liRepairs When the analyzer does notfunction Contact your distributor well Repair within the guaranteed period Repair is made under conditions of the certificate Repair after the guarantee has A repair fee is necessary expired SP 4430 5 11 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL MEMO Chapter 5 TROUBLESHOOTING 5 12 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 6 APPENDIX 6 1 Transmission Specifications 6 1 1 Protocol 6 1 2 Format 6 1 3 Format for measurement result format 1 6 1 4 Format for measurement result format 2 SP 4430 6 01 DOC No OM 28573 REV 6 03 02 6 1 Transmission Specifications SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 6 APPENDIX 6 1 1 Protocol Data format Baud rate Hand shake Time gap Forced finish 6 02 SP 4430 Transmission format Start stop system asynchronous unidirectional transmission by serial transmission format in compliance with J IS X5101 One character consists of the following 11 bits Start bit 1 bit Data bit 7 bits ASCII code Parity bit 1 bit even Stop bit 2 bits Baud rate can be selected out of the following 6 rates 300 600 1200 2400 4800
68. asma 1 Gently pipette 100 1 of HDL Separation Reagent into the tube Cap the tube tight e Invert the sample more than 10 times following to 2 14 Inverting a sample and Serum sampletube leave the sample about 5 minutes Centrifuge the samples for 3 minutes taking Separation Reagen 100aL rotor balance into consideration see page 2 1 1M Check if the supernatant is impure or there is any skin Removing the supernatant is not necessary Uncap the tube and place it directly in the sample rack Serum or plana 1004 Remove any air bubbles or skin on the surface of the sample They may cause incorrect measurement results SP 4430 2 17 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 2 4 Measurement 2 4 1 Normal measurement Chapter 2 MEASUREMENT This section describes the operating procedure of Normal Measurement In Normal Measurement simultaneous measurement of up to nine items is possible for one sample using Single and Multi Reagent Strips Before measurement make necessary preparation as instructed in 2 3 Preparation for Measurement AA WARNI NG Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste
69. asurement results are deleted and the MEASUREMENT RESULTS MENU is restored 5 If STOP key is pressed deletion is Delete canceled and the MEASUREMENT RESULTS MENU is restored 3 End Deletion Press STOP key three times to return to the MAIN MENU Measure Submenu Calibrate 0000 3 08 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Wildcards Wildcards can be used for ID search Wildcards have two types of characters indicating a single or any number of characters e indicates a single character e indicates any number including zero of characters For instance if key is entered 4 character IDs are retrieved If A is entered IDs starting with A are retrieved The following table shows details Searching Pattern Meaning Example 1 5 character ID ending with 2 AB YZ 5 character ID starting with AB and ending with Y Z Example 3 7 ID starting with AB and ending with YZ 4 PQR x ID including PQR Example 5 ID of 4 characters or more starting with This function is upper lower case sensitive The characters key themselves cannot be searched for e g To search IDs
70. at in SP 4410 or SP 4420 The receiving program designed to receive the measurement results of SP 4420 extended format can normally receive the measurement results of SP 4430 format 2 Transmission data of measurement results format 2 A When only Reagent Strips are measured I hen transmitting the measurement resulte with format 2 1 irem output as 1 block The order of the items are Multi Reagent Strip Single Reagent Strip Data in Ilem 1 Data in 2 A Data n The end of the block all block lt di Format of data in item x a an sponsor pepe Te a o os ze oer oea oea on oe os oe oy onl el eee 551 262063 264 05s ose 067 ose oes aee oes nea aes aes oe oes aes mum uium mum favor uva oa os are o77 o7 ox aeo veri osz pes ned oes oe oss oss For 1 LL UI When D is available D output Wher there is ID only te first 10 digits are output The m essurem ent number is expressed 4 digits without zero control For the measurement mum ber blank is used for 0317036 Sample numbertypez For D 1 Farnumber os The m ssim um number of item s in the measurement 017 os order of maximum num ber of items
71. ather dust which may result in incorrect measurement results SP 4430 2 07 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 2 2 4 Handling magnetic cards NOT place a magnetic card close NOT scratch the magnetic surface eDo NOT use a magnetic card supplied to a magnetic object magnet TV set stripe Information on the magnetic with Reagent Strips or Calibrator for etc Information on the magnetic card card may become unreadable SP 4420 or SP 4430 with other devices may become unreadable The card may become jammed in the device 2 2 5 Handling tips C oC NOT touch the pointed end Tip eDo NOT reuse a tip Water repellent with bare hands If it becomes soiled treatment is applied to each tip so that correct sampling may not be possible the sample can be pipetted correctly resulting in incorrect measurement If it is rinsed the coating will come off results and correct measurement results may not be obtained 2 08 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 2 6 Handling centrifuges a high leek ePipette 250 1 to 270 1 of whole blood into the centrifuge tube Insufficient sample volume may result in incorrect measurement results Excessive vol
72. chine contains heparin SP 4430 6 2 15 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT sample They may cause incorrect measurement results Measuring the Hb When measuring Hb dilute whole blood Orange cap samples 6 times with distilled water Prepare a Whole blood Sample Tube orange i cap Whole blood sample tulu Uncap the tube and pipette the whole blood sample into the tube Cap the tube tight i Invert the sample several times see 2 14 Inverting a sample distilled 1 Prepare a Serum Sample Tube blue cap 4 A Pipette 200 41 of distilled water Pipette 40 1 of the prepared whole blood Blue i i sample into the above Serum Sample Tube e Cap the tube tight Serum sample tube Invert sample several times again winds binnd sample i distilled 2 i Widely Y ag Remove any air bubbles or skin on the surface of the 2 16 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT p gt If HDL C reagent direct method M ae 1 is used for measurement this Using HDL C Kits Prepare a Serum Sample Tube blue cap Serum or plasma Pipette 100 1 of serum pl
73. d High 2 vials each 2 vials of dilution 1 77041 Calibrator Hb Kit Calibrator and dilution for Hb meas 1 77042 Calibration Check 4 pieces of lyophilized serum 3 mL 1 77043 Tip Set EZ 100 pieces 1 10711 Tip Set EZ 500 pieces 1 10743 Centrifuge Tube 100 pieces 1 10712 Parts sold separately Item Specifications Qty Product code AC Adapter 1 10692 Cleaning Wire 1 10698 Cleaner Set Brush 5 cotton swabs 1 10208 Power Code For 230 V 1 11742 Pipette for solution For3mL 1 10193 Pipette for Hb Meas For 40 mL 200 1 1 each 1 10194 Sample Rack For 30 sample tubes 1 10199 Nozzle Set EZ Replacement Nozzle O ring 1 10699 Tool Set for Nozzle Replacement 1 10700 Waste Case 2 pieces 1 10701 Protective Cover 2 pieces 1 10702 optional Item Specifications Qty Product code Hand held Bar Code Reader RS 232C Specifications 1 95236 Portable Centrifuge CF 9520 1 18203 RS 232 C Connection Cable Modular 6P D SUBO9P Inch thread 1 10703 Carrying Case Common Specifications for SPOTCHEM series 1 10704 WSingle Reagent Strip SPOTCHEM II Item Specifications Qty Product code Glu 50 1 77270 50 1 77271 T Cho 50 1 77272 TG 50 1 77273 BUN 50 1 77274 T Bil 50 1 77275 Ca 50 1 77276 T Pro 50 1 77277 Alb 50 1 77278 GOT 50 1 77279 GPT 50 1 77280 LDH 50 1 77281 CPK 50 1 77282 Hb 50 1 77283 Amy 50 1 77284 GGT 50 1 77285 ALP 50 1 77286 Cre 50
74. e In the end set the sample type to 000 00000 use on the basic setting The entered sample type is used as the sample type unless a different type is set at the time of measurement Press key to select sample type to use as the basic setting and press Enter key Save The Entry check screen is displayed Yes START Nd 5 4 Saving the setting contents Press Start key or Stop key x Pressing Start key saves the details Writi ngnr of the setting and returns the screen to the PARAMETER MENU 1 2 If Stop key is pressed the PARAMETER MENU 1 2 is restored without saving the setting contents Print Initialig 5 End setting Press STOP key twice to return to the MAIN MENU Measure j Submenu Calibrate 0000 3 20 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU 3 3 5 standard range setting 1 Display setting screen e Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed e Press 2 key The PARAMETER MENU 1 2 is displayed e Press Menu key or key e Press 5 key The Standard range setting copy screen The cursor is in the sample type on the original screen e Press key to select the sample type for which the standard range is set on the original screen Press Enter
75. e Standby screen is restored closing Stop 5 p gt After the Table Cover is closed a message shown at the right is MENU STOP displayed us the MAIN MENU MEAS ENTER press STOP key When ENTER key is pressed the Table Cover opens and the Standby screen is restored 5 Turn off the power e When terminating the operation or Measure j Submenu setting turn off the power after making sure that the MAIN MENU is displayed Calibrate 0000 1 14 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION 1 4 4 Notes at transportation AA WARNING When carrying the analyzer in cars use an exclusive carrying case The carrying case is optional Follow the following procedures to prevent exposure to pathogenic microbes and damage to the analyzer Wear protective gloves to prevent exposure to pathogenic microbes 1 Inspect the inside of the analyzer e Press 1 the MAIN MENU The Table Cover opens and the Reagent Measure Submenu Calibrate Table and Centrifuge equipped M ulti Rack slide forward The Standby screen is displayed Standby e Make sure that there are no used Reagent Strips or samples If any discard them e When there are used tips in the Tip Waste Case discard them e Press STOP to return t
76. e entry position for the upper limit value e Enter the upper limit value with the numeric keys Press Enter key The Entry check screen is displayed il When sample type is set e Enter the lower limit value of the standard range for the sample typel e Press Enter key to move the cursor to a place for the upper limit value e Enter the upper limit value with the numeric keys and press Enter key e Similarly set the standard range for sample types 2 to 5 The Entry check screen is displayed DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU N D t Normal 5000 SUD Savel Yes START STOP Savel Yes START 5 SP 4430 6 3 15 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 7 Store all the parameter settings e Press START or STOP If START key is pressed the Writi ng 00 parameter settings are saved and the Measurement item selecting screen is restored If STOP key is pressed the setting is canceled and Measurement item selecting screen of procedure 1 is restored 8 End setting e If the setting is finished press STOP
77. e ette e edente 1 06 Parts Desc ription and Function 1 07 1 3 1 Front of the analyzer 1 07 1 3 2 Operator panel 1 08 1 3 3 Rear of the analyzer 1 09 Setting up the Analyzer a 1 10 1 4 1 Cautiols eroe e etre 1 10 1 4 2 Setting up the analyzer 1 12 1 4 3 First operation after setting up 1 13 1 4 4 Notes at transportation 1 15 Outline of 2 02 2 1 1 SPOTCHEMII Reagent 2 02 2 1 2 Normal measurement RR Rm 2 03 2 1 3 Calibration oo 2 04 CAUTION See en 2 06 2 2 1 CaulOonhs oec c e 2 06 2 2 2 Handling samples eee 2 07 2 2 3 Handling Reagent Strips 2 07 2 2 4 Handling magnetic cards eee 2 08 2 2 5 Handling tips 2 08 2 2 6 Handling centrifuges ee eee 2 09 Preparation for 2 10 2 3 1 Preparation nie 2 10 2 3 2 Startup 2 11 2 3 3 Checks before measurement e 2 12 2 3 4 Preparation of samples 2 13 2 18 2 4 1 Normal 2 18 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU Chapter 4 MAINTENANCE Chapter 5
78. e is only one stripe for Hb this screen is not displayed If no key entry is made within 3 minutes after the Table Cover opens an alarm sounds and the Table Cover closes If press STOP key is pressed while CANCEL is displayed the Standby screen is restored without closing the Table Cover Afterthe Table Cover closes the message shown on the right is displayed To go back to the MAIN MENU press STOP key To go back to the Standby screen press ENTER key SPOTCHEM EZ SP 4430 OPERATING MANUAL 4 Insert calibration card e Press 2 key on the CALIBRATION MENU The Magnetic card entry screen is displayed e Insert the stripe of a calibration card in the magnetic card reader and slide the card to the right e When the stripe is inserted the message shown on the right is displayed e Insert the same stripe again according to the message on the screen When the same stripes are inserted twice that stripe number is displayed on the lower part of the screen The entered stripes are displayed as Bi e Insert the rest stripes twice according to the message on the screen When all stripes are inserted lot number of the calibrator is displayed After that the Calibration standby screen is displayed e The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi Rack slide forward e The Calibration standby screen as shown on the right is displayed DOC No OM 28573 REV 6
79. ed to be calibrated AA WARNING Wear protective gloves in order to avoid exposure to pathogenic microbes Set the Reagent Strip correctly Return to the menu because the changing item is not allowed during calibration by calibrator kit E14 0000 000000 0 000000000 70 9 Single type Multi type Channel with used Reagent Stip in either case Used Reagent Strip is already used The reagent pad is colored because of old Reagent Strips or inappropriate preservation The reagent pad is dirty The bar code was not correctly read due to displacement or bending of the Reagent Strip AA WARNING Wear protective gloves in order to avoid exposure to pathogenic microbes Use a new Reagent Strip Set the Reagent Strip correctly E15 000 00 0000 0000 000000000 70 9 Single type Multi type Channel with no information for measurement in either case The error is not displayed when the magnetic card is inserted Reagent Card for the item to measure is not inserted The bar code was not correctly read due to displacement or bending of the Reagent Strip When this occurs in measurement with a Multi Reagent Strip Reagent Card for a multi reagent is not inserted for measurement Reagent Card for an item with no information for measurement is inserted AA WARNING Wear protective gloves in order to avoid expos
80. een lot numbers at em m right Lot number of a Reagent Pbi Strip is printed on the rear side of qh the aluminum foil package or on the Ng 3f box uu IMPORTANT If the lot numbers of the Reagent Strips are different from those shown on the screen perform Calibration by magnetic card before measurement be Besides hyphen key 01 2 Press hyphen key to check the 4 5 6 and 8 keys can be used in selecting items information of the reagent strip you 0 gt initially displayed item are using 2 gt last item 4 gt previous item 4 When confirmation is completed gt first item 5 gt first item of the Mult press STOP key The Standby Standby 000000000 Reagent strig screen is restored 10900 INFA p gt f no key entry is made within 3 minutes after the Table Cover is opened an alarm beeps and the Table Cover is closed If STOP key is pressed while the message CANCEL is displayed the Table Cover remains open and the Standby screen is restored Cover is closing Stop STOP p gt After the Table Cover is closed a message shown at the right is displayed To restore the MAIN MENU press STOP key When ENTER key is pressed the Table Cover opens and the Standby screen is restored Back to MENU 5 Back to MEAS ENTER I SP 4430 0 2
81. equipped Multi Rack or other places where sample residue may collect with bare hands When performing maintenance always wear protective gloves to prevent exposure to pathogenic microbes Separate used samples tips and protective gloves from general waste and discard them according to local regulation on biohazardous waste All rights reserved Reproduction of this manual is forbidden The contents of this manual are subject to change without further notice Although we take all possible measures to ensure the contents of this manual please notify your distributor when you have questions or find errors or omission FS SP 4430 02 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Caution Marks Pay careful attention to these caution marks in this Operating Manual llRegarding accident resulting in injury or death To prevent infection of yourself or others from AA WARNING His die c pathogenic microbes follow the instructions given herein To prevent injuries to yourself or others or material NCAU TION damages follow the instructions described MRegarding damage and performance of products Failure to follow the instructions may lead to incorrect IMPORTANT To prevent damage to the unit and assist you in making NOTE best use of the capabilities of the analyzer additional explanations and notes are provided herein PE Reference i
82. gent 4 03 4 2 2 Cleaning the Tip Waste Case and Protective Cover 4 06 Periodic _ 4 08 4 3 1 Replacement of Thermal Printer Paper eee 4 08 4 3 2 Cleaning the Optical 4 10 4 3 3 Cleaning the Nozzle eee 4 13 4 3 4 Replacement Of Nozzle o et ttes 4 16 Error Messages oe 5 02 Trouble 5 5 07 After sales 5 11 Transmission Specifications 6 02 6 1 1 Protocol 6 02 6 1 2 Format ooo ee 6 03 6 1 3 Format for measurement results format 1 6 04 6 1 4 Format for measurement results format 2 6 08 SP 4430 06 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL MEMO 07 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION The SP 4430 is an automated biochemical analyzer using a dry chemistry system This chapter contains the information on the functions and measurement principles of the SP 4430 1 1 Outline 1 1 1 Features 1 1 2 Measurement principles 1 1 3 Specifications 1 2 Shipping Carton 1 2 1 Analyzer 1 2 2 Accessories 1 3 Parts Description and Function 1 3 1 Front of the analyzer 1 3 2 Operator panel 1 3 3 Rear of the analyzer 1 4 Setting up the
83. gloves separately from general waste according to local regulations on biohazardous waste 1 Move the Nozzle to stand by position Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed j Measure 5 Calibrate e Press 3 key The Table Cover opens and the Results PARAM Reagent Table and Centrifuge j Maintenance 00000 equipped Multi Rack slide forward The Nozzle Driving Unit moves to Ready the left end in the analyzer Please turn off Turn OFF the power TION Make sure the power is OFF before moving on to the next procedure Otherwise it may cause injury by contacting with the driving unit of the analyzer 2 Lay the analyzer on its side Remove the Tip Waste Case from the Centrifuge equipped Multi Rack NOTE Make sure that all used Reagent Strips samples and tips are removed 4 10 6 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE Turn over the analyzer carefully so that the right side to which small legs are attached faces down Do NOT hold the Table Cover while turning the analyzer NOTE Do NOT damage the connecting part of the Table Cover Be careful not to tip over the analyzer to avoid damage 3 Clean the Optical Window e Remove the rubber cap on the bottom of the a
84. he remained paper as it is fed out 408 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE pe make the printer ready for printing press FEED key 3 Prepare new printer paper Cut off a single turn of the paper of new roll Cut the top end straight to avoid a paper jam 4 Set new printer paper Place a new roll of paper in the paper holder with the paper end facing up Insert the top of the paper end into the slot The paper starts to be rolled and fed automatically Press FEED key once The printer becomes ready for printing 5 Close the printer cover e Close the printer cover until it clicks into place NOTE Be careful not to touch the paper cutter to avoid injury 5 4430 0 4 09 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 4 3 2 Cleaning the Optical Window If dust is adhered to the Optical Window correct measurement result may not be obtained due to improper detection of reflect on light caused by fluctuation of wavelength Clean the Optical Window once every 2 000 measurements Cotton swab Distilled water and Protective gloves AA WARNI NG Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective
85. ip Waste Case into the Centrifuge equipped Multi Rack 5 Disinfect and wash the Protective Cover e Disinfect the Protective Cover with alcohol and wash it with tap water e Wipe it dry with a cloth 6 End cleaning e Turn ON the power Warm up starts The Reagent Table Warming uppnp and Centrifuge equipped Multi Rack slide back to the original position and the Table Cover closes e If the operation is completed turn OFF the power after the MAIN Measure Submenu MENU is displayed Calibrate 00000 SP 4430 4 07 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 4 3 Periodic Maintenance Chapter 4 MAINTENANCE 4 3 1 Replacement of Thermal Printer Paper When the printer paper runs out a red line appears on both sides of the printer paper If the line is seen replace it with a new roll Approximately 500 measurements can be printed out on one roll of paper New thermal printer paper roll and Scissors 1 Cut printer paper Make sure that the MAIN MENU is displayed Measure j Submenu Calibrate 0000 Open the printer cover If paper remains the printer cut it off with scissors and remove the remained paper If no paper remains in the printer remove the tube and proceed to Procedure 3 2 Remove the remained paper Press the FEED key Pick and remove t
86. key The cursor moves to the sample type on the duplicate screen lInitiali Submenu D agg n Results PARAM j Maintenance 0000 The standard range setting for a certain sample type can be copied in all items to one for another sample type Copy is available only when two or more sample types are input 0 Uu pU UWUUUUUUU 2 Selecting the standard range the original screen UUUUUUUUU wou SP 4430 3 21 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 3 Selecting the standard range of the duplicate screen e Press key to select sample type on the duplicate screen for which 0 the standard range setting is required Press Enter key The Entry check screen is displayed Savel Yes START 5 4 Saving the setting contents Press Start key or Stop key nes Press Start key to copy and save the Writi standard range The PARAMETER MENU 1 2 is restored Press Stop key to return the screen to the PARAMETER MENU 1 2 without duplicating the standard Print Initiali
87. layed e After the analyzer name and system Warming uppoo version are displayed warm up starts pe For error correction e About 10 minutes after room troubleshooting see Chapter Measure 6 bme nu 5 Troubleshooting temperature at 25 warm up is Calibrate 0000 completed and the MAIN MENU is displayed as shown at right 2 Set the thermal printer paper e Set the attached thermal printer paper See 4 3 1 Thermal printer paper replacement 3 Confirm the time and date eet the date and time see 3 6 Built in Clock Adjustment IMPORTANT If the date is not set correctly correct measurement results may not be obtained and an error may occur 4 Remove the fixing tape on the protective cover e Press 1 the MAIN MENU The Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack slide forward SP 4430 0 1 13 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION Remove the tape fixing the protective cover Set the maintenance cover and the tip waste case Press STOP to close the table closing 0 p gt f no key entry is made within 3 minutes after the Table Cover is opened an alarm beeps and the Table Cover is closed If STOP key is pressed while the message CANCEL is displayed the Table Cover remains open and th
88. lect measurement items for 4 5 6 and 8 keys can be used in selecting items parameters by pressing hyphen 0 gt initially displayed item key 2 gt last item 4 gt previous item 6 gt next item e Press ENTER key T 8 gt first item 3 emperature 5 gt first item of the Multi The Temperature setting screen is Reagent Strip displayed 0 1 0 3 Set temperature Select the temperature from 37 30 C and 25 by pressing hyphen Temperature key 5000 Note that items other than enzyme have only one choice of 37 CC e Press ENTER key The Coefficient factor setting screen is displayed 4 Set coefficient factor be To enter minus signs and decimal points use key If key is pressed first a minus sign is entered To enter using the numeric keys Any number a decimal point press from 0 to 10000 can be entered after any number is entered e g To enter 12 Press 1 2 Enter the coefficient factor a by Press ENTER key The cursor e g To enter 3 4 moves to the entry position for Press 3 4 e g To enter 5 Enter a coefficient factor b and press 011 151 press ENTER key Any number from If 5 are pressed the result will be
89. ment or additional measurement sample quantity may be short Shortage of sample amount may lead to incorrect results due to sucking of blood cells or trouble because of abnormal rotation of centrifuge Make sure that the remaining sample amount is enough and perform remeasurement or additional measurement Press 0 key on the Standby screen The Centrifuge selecting screen is displayed On is always displayed at the beginning Standby 000000000 10100 switch On and Off of centrifuge press 0 key on the Standby Centrifuge selecting screen To perform the measurement on the screen of No centrifugation be sure to use the centrifuged sample If uncentrifuged sample is used correct measurement result may not be obtained 8 Set the Reagent Strips In Normal Measurement the following three settings are available eMulti type Reagent Strips and Single type Reagent Strip Multi type Reagent Strips only eSingle type Reagent Strips only Choose one depending on the item to measure Set the Multi type Reagent Strips e Open the aluminum foil package from the place written AOpen here A until two thirds of the Reagent Strip is exposed Muki type Reagent Strip SP 4430 2 23 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT
90. mperature 37 C Light source LED and Interference filter Calibration method Calibration by magnetic card Reagent Card Calibration by Calibrator Kit Data storage volume 100 tests Display 20 digits X2 lines LCD Built in Printer 36 character thermal printer 58 mm width External Output RS 232C interface Transmission Method Single or Two way Transmission Transmission Rate 300 600 1200 2400 4800 9600bps Measurement conditions Temperature 10 30 Humidity 20 80 96 Non condensing Power supply AC100 120V 220 240V 50 60Hz AC adapter method Power input Max 100VA Dimensions 338 mm W x203 mm D x167 mm H Weight Approximately 5 4 kg SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 1 2 Shipping Carton 1 2 1 Analyzer Open the package and confirm that all items are included Chapter 1 INTRODUCTION 1 Menke S450 Z Power mdopler Roe oo 6 nma y cord will cose Weador SS NO Item Description Qty 1 Analyzer SP 4430 1 2 Power cord 1 3 AC adapter 1 4 Accessory case 1 5 Operating manual This book 1 6 Warranty card Warranty card with case Delivery label lset d SP 4430 1 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION 1 2 2 Accessorie
91. mpleted thr rear maia aru printed by the printer Finem ary Reagent Firipa and dispose of ham Wi imb Furr bpp oh iced decope Of tpa te Wana SP 4430 2 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 2 1 3 Calibration This analyzer provides two types of calibration Calibration by magnetic card Reagent Card and Calibration by Calibrator Calibration must be performed for all fields of Reagent Strips see 2 5 1 Outline of calibration for details For calibration by Calibrator the following two types of Calibrator Kit and Magnetic Card Calibration Card are used IISPOTCHEM Calibrator Kit For use with all items except Hemoglobin IISPOTCHEM Calibrator Hb Kit For use with Hemoglobin Each Calibrator Kit contains Low and High lyophilized serum and a Calibration Card For detailed procedures see the package insert of the Calibrator Kit 2 04 SP 4430 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPE RATING MANUAL Chapter 2 MEASUREMENT bration The flowchart of cal 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 Puhmuuu SP 4430 2 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 2 2 Cautions Chapter 2 MEASUREMENT 2 2 1 Cautions temperature
92. nalyzer Wipe out stains and dust adhered to the Optical Window transparent glass plate with a cotton swab moistened with distilled water Wipe out remained cotton swab fibers and moisture of the Optical Window with a new dry cotton swab Check it the Optical Window is clean and dust free Use a flashlight to make the checking easier SP 4430 0 4 11 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 4 Restore the analyzer Reattach the rubber caps firmly to the bottom of the analyzer Carefully turn over the analyzer to the original position without holding the Table Cover NOTE Do NOT damage the connecting part of the Table Cover Be careful not to tip over the analyzer to avoid damage 5 End cleaning Attach the Tip Waste Case to the Centrifuge equipped Multi Rack Turn ON the power Warm up starts The Reagent Table Warming and Centrifuge equipped Multi Rack slide back to the original position and the Table Cover closes When the operation is completed turn OFF the power after the MAIN MENU is displayed Measure Submenu Calibrate 0000 412 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE 4 3 3 Cleaning the Nozzle J WARNING ANCAUTION A CAUTION
93. neral waste according to local regulations on biohazardous waste 1 Slide the Reagent Table forward Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Submenu Calibrate 0000 Press 3 key Results PARAM Maintenance 0000 The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi Rack slide forward Ready Turn OFF the power Please turn off 2 Clean the Reagent Table Brush off dust on the Reagent Table with a cleaning brush toward you Be sure to brush dust toward you not toward the analyzer Otherwise malfunction of the analyzer may occur SP 4430 0 4 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 4 04 6 SP 4430 Moisten a cotton swab with distilled water and wipe out stains or dust adhered to the Reagent Table Clean the groove well carefully not to break the lugs on the tip of the groove If the Reagent Table is wet wipe using a dry cotton swab If any fiber is remained on the Reagent Table brush it off with the cleaning brush again Do not spill water on the analyzer to avoid damage Wipe out dust adhered to the table pins with a cotton swab Clean the black and white plates Cleaning the black and white plates once a week NOTE The black and white plates are reflectors
94. nformation on operation additional explanations and related functions are provided herein 03 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Caution Labels Caution Stickers AY are adhered to the SP 4430 to prevent accidents below The descriptions are on the following pages 1 Biohazard cautions Wear protec Bue gowes to prevent exposure pathogenic microbes 2 The centrifuge turn round athigh speed Keep your hands off when mesurementis in process Biohazard cautions Wear protec Bue gowes to prevent exposure pathogenic microbes 3 Biohazard cautions Wear protec iue giouwes to prevent exposure pathogenic microbes 5 4430 04 DOC No OM 28573 REV 6 03 02 Contents SPOTCHEM EZ SP 4430 OPERATING MANUAL Automated biochemical analyzer SP 4430 Chapter 1 INTRODUCTION Chapter 2 MEASUREMENT 05 SP 4430 Premlise oem b Stes 01 02 Caution Marks RR RR Ret 03 Caution Labels sis ss eot 04 1 1 1 2 1 3 2 1 2 2 2 3 2 4 Outline ei ee 1 02 1 1 1 Features oo e02 1 1 2 Measurement principles 1 03 1 1 3 Specifications 1 04 Shipping Carton 1 05 1 2 1 Analyzer e enm 1 05 1 2 2 ACC SSOLCles o eorteen
95. ng of Nozzle Once every 10 000 measurements 4 13 or once a year Replacement of Nozzle When a trouble occurs or 4 46 once a year AA WARNI NG Cleaning of the parts marked with on the table above requires user to wear protective gloves to prevent exposure to pathogenic microbes Discard any replaced parts or used cleaning tools separately from general waste according to local regulations on biohazardous waste 402 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 4 2 Daily Maintenance Chapter 4 MAINTENANCE 4 2 1 Cleaning the Reagent Table J WARNING A CAUTION With numerous measurements residue of sample and Reagent Strips stay on the Reagent Table When they are adhered to a new Reagent Strip correct measurement results may not be obtained or Reagent Strips may be jammed inside Clean the Reagent Table daily after use to ensure that correct measurement results can be obtained all the time Also clean the black and white plates and the Rubber Plate once a week If those plates are dusty correct measurement results may not be obtained Refer to the next page for cleaning procedures Perform occasional cleaning between measurements if necessary Cleaning set brush cotton swabs Distilled water and Protective gloves Wear protective gloves to prevent exposure to pathogenic microbes Discard used samples tips and protective gloves separately from ge
96. o the MAIN MENU and turn off the power switch Measure Submenu Calibrate 0000 2 Placing analyzer into carrying case Place the analyzer AC adapter and power code in the carrying case SP 4430 6 1 15 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL MEMO 1 16 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT The normal measurement and two types of calibration can be done with the SP 4430 This chapter describes the outline and operating procedures of each measurement 2 1 Outline of Measurement 2 1 1 SPOTCHEMII Reagent Strips 2 1 2 Normal measurement 2 1 3 Calibration 2 2 Cautions 2 2 1 Cautions 2 2 2 Handling samples 2 2 3 Handling Reagent Strips 2 2 4 Handling magnetic cards 2 2 5 Handling tips 2 2 6 Handling centrifuges 2 3 Preparation for Measurement 2 3 1 Preparation 2 3 2 Startup 2 3 3 Checks before measurement 2 3 4 Preparing samples 2 4 Measurement 2 4 1 Normal measurement 2 5 Calibration 2 5 1 Overview of calibration 2 5 2 Calibration by magnetic card 2 5 3 Calibration by calibrator kit 2 6 Interpreting measurement results 2 6 1 Printing normal measurement results 2 6 2 Printing calibration results SP 4430 2 01 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 2 1 Outline of Measurement 2 1 1 SPOTCHEMII Reagent Strips Chapter 2 MEASUREM
97. ole blood Cap the tube tightly Whole blood tubs Invert the sample 5 to 6 times see Inverting a sample on the next page SP 4430 2 13 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT Inverting a sample to mix 1 Gently invert a sample tube p gt Even if the sample stays at the bottom after being inverted heparin is well mixed with the sample Do NOT shake the tube vigorously 2 In 3 seconds invert the sample again 3 Wait for 3 seconds and invert it again 4 Repeat the above procedure several times NOTE When using an optionally available centrifuge carefully read the Operating manual of the centrifuge Place the samples in the centrifuge taking rotor balance into consideration see the block below Centrifuge the samples for 3 minutes or more It is not necessary to remove the supernatant from the centrifuged samples Uncap the tubes and place them directly in the sample rack IMPORTANT Remove any air bubbles or skin on the surface of the sample They may cause incorrect measurement results Ensuring rotor balance M Sanples amp Dunmnytube Place sample tubes D E symmetrically against the rotation n a D axis as illustrated at right For centrifugation of 1 or 5 samples 1 Samples use a dummy tube filled with an equal amount of water to make a total of 2 or 6
98. ozzle replacement tool and Protective gloves AA WARNI NG Wear protective gloves to prevent exposure to pathogenic microbes TION Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste 1 Move the Nozzle to stand by position Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Measure Submenu Calibrate 0000 Press 3 key The Table Cover opens and the Results PARAM Reagent Table and Centrifuge j Maintenance 00000 equipped Multi Rack slide forward The Nozzle Driving Unit moves to Ready the left end in the analyzer Please turn off e Turn OFF the power A CAU TION Make sure the power is OFF before moving on to the next procedure Otherwise it may cause injury by contacting with the driving unit of the analyzer 2 Remove the cover Remove the top cover by sliding to the left 416 6 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE Remove the side cover 3 Remove the Tip Waste Case eLoosen the fixing screws remove the tip ejector Remove the Tip Waste Case 4 Replace the Nozzle Fasten the upper part using the narrow side of the wrench Insert the adapter from the bottom and rotate it using the wide side of
99. ransmission is completed the Measurement result selecting screen is restored e When SEARCH is selected The display proceeds to step 3 pe 1 the measurement result selected is not found in the data No matching data is No d ata matc h e d displayed as shown on right Press ENTER key to return to OK ENTER the Measurement result selecting screen 3 06 6 SP 4430 If designation of the range of measurement dates the dates of starting finishing measurements is unnecessary press ENTER key twice to proceed to the next setting screen Be sure to enter correct dates to avoid inconsistencies The 2 digit number of the year section of the date indicates the last 2 digits of year and is interpreted as follows 00 89 gt 2000 2089 90 99 gt 1990 1999 See 3 09 page for information on wildcards If the selected measurement result is not found in the data No matching data is displayed as shown on the right Press ENTER key to return to the Measurement result selecting screen SPOTCHEM EZ SP 4430 OPE RATING MANUAL 3 Enter searching condition Enter the dates of starting and finishing measurements by sliding the cursor using hyphen key Press ENTER key The ID entering screen is displayed Press ENTER key when not searching by ID Enter an ID searching pattern for the sample s to print by using numbers alphabets and symbols up to 1
100. rement item selecting screen is restored Measure Submenu Calibrate 0000 Results Maintenance 0000 Print lInitiali Password Cancel 5 Initialize Yes START Na 5 SP 4430 3 17 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 3 SUB MENU 3 End Initialization e f the initialization is finished press Measure j Submenu STOP key three times to return to the MAIN MENU Calibrate 00000 Factory setting values The following measurement conditions are pre set upon shipment at the factory i Refer to the table when setting parameters i p gt The present parameter settings can be printed out See 3 3 1 Print Parameters Setting item and range Factory setting value j Temperature 25 C 30 C 37 C 37 C Coefficientof a 0 10000 a 1 0 correlation b 10000 10000 b 0 0 Standard range L 0 10000 H 10000 10000 Measurement range Calibration type Calibration type Cal or CARD CARD Number of times 2 to 6 times 2 3 18 6 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 3 SUB MENU 3 3 4 Enter sample type
101. ring parameters 2 28 SP 4430 e SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT 2 5 2 Calibration by magnetic card By inserting Reagent Card attached to Single Reagent Strips or another one attached to Multi Reagent Strips into a magnetic card reader differences among lots and changes with time of reagent pack are automatically calibrated IMPORTANT For the lot number of Reagent Card for magnetic calibration use the same lot number as that of the reagent strip currently in use Magnetic cards attached to the Reagent Strips in use Calibration can not be performed with magnetic cards with different lot number or magnetic cards with different Reagent Strips Reagent Car 1 Set the calibration type as by magnetic card e When changing the calibration type from calibration by calibrator kit to calibration by magnetic card CARD change the setting see 3 3 2 Enter parameters If the calibration type is already set as calibration by magnetic card this operation is not necessary 2 Set the calibration condition p gt CARD means calibration by e Press 3 key on the MAIN MENU nM Sub 2 The CALIBRATION MENU is Calibrate calibrator kit displayed T CARD j Information 00000 3 Insert Reagent Card p gt Press STOP key to stop the Press 1 key on the CA
102. rs 3 3 4 Enter sample type 3 3 5 Copy standard range setting 3 4 Maintenance 3 5 Mode Menu 3 6 Built in Clock Adjustment SP 4430 3 01 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 3 1 Overview of SUB MENU rm 3 1 1 Composition of SUB MENU MAIN MENU After the power is ON and warm up is completed the MAIN MENU is displayed In the MAIN MENU normal measurement calibration and the SUB MENU are available When START key is pressed SUB MENU on any screen of SUB MENU the MAIN MENU is restored The SUB MENU consists of 2 pages Press MENU key or hyphen key to switch the SUB MENU pages alternately between SUB MENU 1 2 and SUB MENU 2 2 In the SUB MENU there are several functions to be set and they are arranged in layers This chapter partly describes the SUB MENU DD ELEC i oe sees EL C LEE hii ere ae ge ease Senne ere re se reser a CLE CELL E aL LRL LUCES MAN MENU 1 Meare X ei i SUBMENU 12 1 Nail da 5 PARAN 1 Pelat d dead Liten iti Cl SUS MENU 22 3 02 5 4430 SPOTCHEM EZ SP 443
103. s Open the package and confirm that all items are included 1 Tip 2 wie 3 Cheer t t MI ae sel for rozzi repe meak Tip wee creme Febe comer NO Item Description Qty 1 Tip 10 tips 1 Set 2 Cleaning wire Nozzle cleaning 1 Set 3 Cleaner set Brush Cotton swab 1 Set 4 Nozzle set EZ Nozzle with O ring 1 Set 5 Wrench set for nozzle replacement 2 Wrench Adapter 1 Set 6 Centrifuge tube 10 pieces 1 Set 7 Tip waste case 2 pieces 1 Set 8 Protective cover 2 pieces 1 Set 9 Thermal printer paper width 58 mm 1 Set 1 06 SP 4430 d SPOTCHEM EZ SP 4430 OPE RATING MANUAL 1 3 Parts Description and Function DOC No OM 28573 REV 6 03 02 Chapter 1 INTRODUCTION 1 3 1 Front of the analyzer 13 Maintenance cover 12 Built in printer 000 11 Magnetic card reader b 19 Display pane Pi 77 Blask 1 Reagent abk 3 Pan C NE amp Tip hole 8 Tip waste NE F x ee d 14 Prasina cover T 4 Table caver 2 Muhi Hack NO Item Function 1 Reagent table For setting the Reagent Strip The temperature is kept at 37 C for the reaction conditions of Reagent 2 Centrifuge equipped Multi Rack For setting the samples
104. s If measurement is continued it may cause trouble 2 38 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 2 6 Interpreting measurement results 2 6 1 Printing normal measurement results Chapter 2 MEASUREMENT To print out the measurement results Normal printing and Survey Mode printing are available The Survey Mode has the following additional items to the print out of the Normal mode These items are printed out when the Survey Mode is ON e Measurement value which temperature conversion unit conversion or correlation correction is not applied e Information on temperature conversion temperature and temperature conversion factor e Information on unit conversion unit and unit conversion factor e Information on correlation correction coefficient of correlation correction SP 4430 2 39 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT 1 Normal printing 5P 4430 V1 00 01 12 34 No Wo 0012 Man ID g NULTI PANEL 1 jo 1 B0 2 pd 2 Alb 2 gdl 4 Ca 2 14 mol l o 4 TG 8 mg dl 5 UA OVER 20 2 mg dl amp LDH UNDER 50 IU L 5 MGLE AMgFO4 9019 BFOFZ 7 GGT 25 25 IU L 8 CAN T MEAS _ 8 Glu 107 mg dl gt When Printing of measurement 1 Version results is performed on the 2 Measurement date and time Date and
105. sample tubes e 4 2 5anples 6 5anples 2 14 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT gt Centrifuge tube has 1 line marked it for 250 Using a centrifuge Prepare a centrifuge Uncap the tube and pipette 250 L of heparinized whole blood or plain blood into the centrifuge tube e The centrifuge tube includes Heparin as an anticoagulant e Close the cap tightly after setting a sample and invert it Use the sample after re e Wipe outthe sample attached to the outside moving the cap of centrifuge tube before placing it to the centrifuge otherwise it sample may spattering the e Place samples in the centrifuge see 2 4 1 Normal measurement IMPORTANT Remove any air bubbles or skin on the surface of the sample They may cause incorrect measurement results Wipe out the sample attached to the outside of centrifuge tube before placing it to the centrifuge otherwise it may cause spattering the sample IMPORTANT The samples may coagulate when it takes time before the samples collected are brought into the machine Those showing heavy coagulation or deposition of fibrin sometimes can not be measure A syringe containing heparin can be used to prevent coagulation when it takes time before the samples are brought into the centrifuge although the ma
106. sults are printed when calibration by calibrator kit is completed The formats of the Single Reagent Strips and the Multi Reagent Strips are slightly different Even when calibration errors E 30 Abnormal data occur during the calibration the calibration results are printed In this case Acal and Bcal are printed as Calibration factors are not set up 1 Calibration Result of Single Reagent Strip SP 4490 V1 00 2000 00 02 12 34 Results of calibration GGT 8 01 AASFO4 2000 11 16 Calibrator ABCDEF Data LO 65 000 HO 500 000 1 1 68 250 510 050 2 67 648 2 511 123 o Mean L 68 344 509 840 Acal 0 985 Beal 2 1 Version 2 Calibration date The date when START key was pressed for the first time 3 From the left name of Multi Reagent Strip item symbol lot number and expiry date 4 Lot no of the calibrator Read by the calibration card 5 Displayed value of calibrator Read by the calibration card 6 Measurement value when calibration is not performed Printed out for the number of calibration times 7 Average measurement value when calibration is not performed 8 Calibration factor Factor of linear expression Y Acal X Bcal to convert the value X of 7 to value Y of 5 Forthe items when calibration mode is L the H part is blank Forthe items when calibration mode is H the L part is blank 2 42 SP 4430 SPOTCHEM EZ SP 4430 OPE R
107. sure to pathogenic microbes Remove dust from the table Reset the Single Reagent Strip correctly Confirm that foreign matter is not attached to the Single Reagent Strip E35 000 00000 The setting such as baud rate of the hand held bar code reader is incorrect The hand held bar code reader is not correctly connected Confirm the setting of the hand held bar code reader such as baud rate Connect the hand held bar code reader correctly 000000000 000 0000000 00000 000000000 Battery is exhausted Charge the battery SP 4430 5 05 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 5 TROUBLESHOOTING Description and error message Conditions and causes Remedy 7 000 00000000 00000 00000000 When sampling air bubbles or fibrin was aspirated When sampling the sample amount was insufficient J WARNING Wear protective gloves in order to avoid exposure to pathogenic microbes Remove air bubbles or fibrin Confirm the sample amount 8 OOO 000 0000 000 000 Forgot to set the Tip Waste Case The Tip Waste Case is not correctly set Set the Tip Waste Case correctly Ug ag BUD 000 00 The cable is not connected The setting e g baud rate of the connected device
108. sured twice and High will be measured next SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 2 MEASUREMENT p gt When performing 1 point calibration for Low only proceed to procedure 13 pe Press STOP key to stop calibration The Calibration standby screen is restored 9 Set the tip e Setthe tip by following procedure 5 10 Set the High Calibrator e Setthe High Calibrator by following procedure 6 11 Set the Reagent Strips Set the Reagent Strips by following procedure 7 12 Measure the High Calibrator e Measure the High Calibrator by following procedure 8 13 End the calibration e When calibration is completed the measurement results are printed Printi non The Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack slide forward The Calibration standby screen is restored LOO HOO Standby Remove the used Reagent Strips and samples and discard them SP 4430 2 37 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT When a message Remove used tips Waste Case and discard used tips D is displayed remove the Tip e Set the Tip Waste Case again Remove used tips OK ENTER NOTE The message Remove used tips is displayed every 5 measurements When this message is displayed discard the used tip
109. tact OOO 0000000000 000 obstruction the operating path of the your distributor DoD 0 0 DU centrifuge base e Trouble with product information e If the same trouble occurs contact T90 memory storage your distributor Power was cut while writing in memory 000 00000000000000 or deleting OOUOUUUUO Trouble with mechanism information If the same trouble occurs contact 9 1 memory storage your distributor Power was cut while writing in memory OOO 0000000000000000 or deleting OOUOUUUUU e Trouble with optical system information e If the same trouble occurs contact T92 memory storage your distributor e Power was cut while writing in memory OOO 00000000000000 or deleting I BD OLD D D DI SP 4430 5 09 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 5 TROUBLESHOOTING Description and trouble message Conditions and causes Remedy e Trouble with parameter memory storage e If the same trouble occurs contact 93 Power was cut while writing in memory your distributor or deleting 000 0000000000000000 0 00 0 000000000 S Single type M XX Multi type The parameter item number found defective in either case 5 10 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 5 3 After sales service Chapter 5 TROUBLESHOOTING llWarranty A warranty is included in this packaging box This w
110. time when START key is pressed Sub Menu the results are printed according to the parameter settings of the measurement That is if the parameters are changed after 3 Measurement number The number is counted starting from 0001 When the power is 4 ID Printed only when ID is set 5 Name of the Multi Reagent Strip 6 Lot Number of the Multi Reagent Strip the measurement temperature 7 Measurement results of the Multi Reagent Strip or coefficient of correlation 8 Lot Number of the Single Reagent Strip Used for S1 52 and 53 channels from the left correction the data after the 9 Measurement results of the Single Reagent Strip measurement is printed out 10 Sample type Printed only when set 5 7 are printed only when the Multi Reagent Strip is measured 8 9 are printed only when the Single Reagent Strip is measured Details The temperature is printed when the temperature is set other than at 37 C in the enzyme item ex GGT Over Max Value is printed when the measurement result is higher than the upper limit of the measurement range ex UA Under Min Value is printed when the measurement result is lower than the lower limit of the measurement range ex LDH A mark is printed when the measurement result is higher than the upper limit of the standard range ex T Pro w mark is printed when the measurement result is lower than the lower limit of the standard range ex Ca
111. ting Confirm the temperature outside f the same trouble occurs contact your distributor NOTE in cases where the abnormality is detected when the power is turned on it is necessary to turn on the power again because the measurement cannot be started 105 000000 000 Trouble occurred at the nozzle up down driving mechanism hit an obstruction when it moved downward or it was caught in the upward movement Turn on the power again Confirm that there is no obstruction f the same trouble occurs contact your distributor u Dg gag pu 000000 000 Trouble occurred in the nozzle right left driving Turn on the power again Confirm that there is no obstruction f the same trouble occurs contact your distributor u Dg gag 000 0000000 00000 000000000 The table cannot function because Reagent Strip is caught in the gap the table The Reagent Strip table cannot function because there is an obstruction in front of the table cover Turn on the power again Remove the obstruction if any Confirm that there is no obstruction in front of the table cover f the same trouble occurs contact your distributor SP 4430 5 07 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 5 TROUBLESHOOTING Description and trouble message Conditions and causes
112. tip 5 08 SP 4430 SPOTCHEM EZ SP 4430 OPE RATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 5 TROUBLESHOOTING Description and trouble message Conditions and causes Remedy Failure to discard tip Turn off the power and remove the 2 1 tip from the nozzle 000 00000000 White plate or black plate is dirty Clean the white plate or black plate T25 Note the case in which trouble is detected when the power is turned 000 0000000 000000 on it is necessary to turn the 0 0 0 0 000000000 power again after maintenance 1 5 7 9 Channels with abnormalities since measurement cannot be started The rotating rate of centrifuge is Remove the obstruction around the T27 defective centrifuge t cannot rotate due to an obstruction e Turn on the power again OOO 0000000000 around the centrifuge e If the same trouble occurs contact 000000000 e Forgot to set centrifuge tube your distributor Cover Protective cover is not attached Protective cover is not properly Set the centrifuge tube Position Stop position is not correct attached Attach the protective cover properly e Trouble occurred in the centrifuge front on the power again T28 back driving mechanism e Confirm that there is no obstruction t cannot operate because of an e If the same trouble occurs con
113. ttached to Multi Reagent Strip is used SP 4430 0 2 31 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 2 MEASUREMENT To check the calibration mode and the 0 50000 GGT 0 0000M L amp H number of calibration times press 3 key on the CALIBRATION MENU to display the Calibration information checking screen On this screen switch the items by pressing hyphen key to check calibration mode and the number of calibration times Press STOP key to return to the CALIBRATION MENU CARD Prepare the required equipment and Information 00000 calibrator see 2 3 1 Preparation Dissolve Low or High solution according to the instructions on the package insert included in the calibrator kit Place 500 1 of Low and High solution in the respective sample tubes Put the caps back on to prevent evaporation or contamination if calibration is not to be carried out immediately IMPORTANT Remove any air bubbles or skin on the surface of the calibrator if any Failure to do so may result in obtaining incorrect measurement results 2 32 SP 4430 p gt stop calibration press STOP key pe There is no order for inserting the stripes Any stripe can be inserted first p gt Insert the same stripes twice to surely read the stored information in the calibration cards Ther
114. ume may cause blood to stain the cover e When it takes time before blood samples collected are brought into the centrifuge the samples may begin to coagulate The samples which show heavy coagulation or deposition of fibrin may not be subjected to measurement A syringe containing heparin can be used to prevent coagulation when it takes time before the samples are brought into the centrifuge although the machinecontains heparin 2 eHeparin is contained as an anticoagulant Close the cap tightly after setting a sample and invert it and use the sample after removing the cap Remove air bubbles or skin on the surface of the sample if any Otherwise they may cause incorrect measurement results Wipe out the sample attached to the outside of centrifuge tube before placing it to the centrifuge otherwise it may cause Spattering the sample Samples with extremely high hematocrit levels may yield incorrect measurement results SP 4430 2 09 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL 2 3 Preparation for Measurement 2 3 1 Preparation Prepare necessary instruments as described in the following table before starting Normal Measurement Calibration by Magnetic Card or Calibration by Calibrator IMPORTANT Take the Reagent Strips out of the ref and leave them at room temperatul 30 for 20 minutes Reagent Sirip IMPORTANT Using Reagent
115. ure to pathogenic microbes Insert a magnetic card corresponding to the item Set the Reagent Strip correctly E16 n 000 0000 000000000 70 9 Single type Multi type Channel with no calibration information in either case Wrong calibration card was inserted The bar code was not correctly read due to displacement or bending of the Reagent Strip 4 WARNING Wear protective gloves in order to avoid exposure to pathogenic microbes Insert the correct calibration card again Hb is a different card Set the Reagent Strip correctly SP 4430 5 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 5 TROUBLESHOOTING Description and error message Conditions and causes Remedy E17 HOU 00 000000 000000 0 000000000 Cuvette when curette is used for liquid level detection CNTRFG When centrifuge vessel is used A sample vessel is misplaced There is no sample or an insufficient amount of sample A centrifuge tube was used in calibration by calibrator kit J WARNING Wear protective gloves in order to avoid exposure to pathogenic microbes Set the sample correctly Confirm the amount of the sample Be sure to use cuvettes in calibration by calibrator kit E21 000 0000 0000000 The magnetic card was caught when inserted
116. y the optical fibers is irradiated on the reagent fields which has a color reaction after sampling Its reflected light is read with 2 photodiodes and the system calculates measurement results by end point assay EPA or reaction rate assay RRA Optical fiber Photodiode Reagent fielc SP 4430 1 03 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 1 INTRODUCTION 1 1 3 1 04 SP 4430 Specifications Sample Serum Plasma Whole blood Only Hb Measurement item General biochemical measurement items 22 items Measurement wavelength 5 wavelengths 405 550 575 610 and 820 nm Measurement principle Optical measurement of reflection intensity of reagent color reaction Measurement Range Set for sach measurement item Reagent Strip SPOTCHEMII Reagent Strip Processing speed 63 samples per hour Minimum sample volume 6 x the number of measurement items 38p L serum plasma Sample consumption 4 6pL per 1 measurement item serum plasma Sample container Whole blood exclusive whole blood sample tube Orange cap Centrifuge tube Serum plasma exclusive serum sample tube Blue cap Simultaneous measurement 3 Single Reagent Strips or 1 Multi Reagent Strip Maximum of 9 test items of continuous measurement using Single Reagent Strips and a Multi Reagent Strip is available Reagent reaction te
117. zle Tube 4 Clean the Nozzle Insert the nozzle cleaning wire into the Nozzle until its tip appears from the other end Clean the inside of the Nozzle by moving the wire up and down a couple of times Wipe out the dust caming out of the tip of the Nozzle with tissue paper 414 SP 4430 SPOTCHEM EZ SP 4430 OPERATING MANUAL DOC No OM 28573 REV 6 03 02 Chapter 4 MAINTENANCE 5 Insert the Nozzle Tube e Remove the nozzle cleaning wire from the Nozzle Pinch the Nozzle Tube with tweezers and insert it into the tube joint 6 Reattach the covers Put the side cover to the analyzer Attach the top cover by sliding to the right 7 End Cleaning Turn ON the power Warm up starts The Reagent Table and Centrifuge equipped Multi Rack slide back to the original position and the Table Cover closes Warming When the operation is completed turn OFF the power after the MAIN Measure Submenu MENU is displayed Calibrate Before turning ON the power make sure that the maintenance cover is installed SP 4430 4 15 DOC No OM 28573 REV 6 03 02 SPOTCHEM EZ SP 4430 OPERATING MANUAL Chapter 4 MAINTENANCE 4 3 4 Replacement of Nozzle With numerous measurements the O ring attached to the Nozzle becomes deteriorated Nozzle N

Arkray Spotchem SP-4430 - Frank`s Hospital Workshop

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