Arkray SPOTCHEM EZ SP-4430 Page 10 Operating Manual Download

Page: 10 / 139

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.

Chapter 1

INTRODUCTION

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 Analyzer

1-4-1 Cautions

1-4-2 Setting up the analyzer

1-4-3 First operation after setting up

1-4-4 Notes at transportation

SP-4430 ● 1-01

Summary of Contents for SPOTCHEM EZ SP-4430

Page 1: ...b SPOTCHEM EZ SP 4430 Operating Manual ...

Page 2: ...TCHEM EZ SP 4430 supplied by ARKRAY Inc 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 Directive 89 336 EEC as amended by Directive 92 31 EEC and to Directive 73 23 EEC 89 392 EEC ...

Page 3: ... 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 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 g...

Page 4: ...ries to yourself or others or material damages follow the instructions described Regarding damage and performance of products Failure to follow the instructions may lead to incorrect results To prevent damage to the unit and assist you in making best use of the capabilities of the analyzer additional explanations and notes are provided herein IMPORTANT NOTE Reference information on operation addit...

Page 5: ...prevent accidents as below The descriptions are given on the following pages 2 The centrifuge turn round at high speed Keep your hands off when mesurement is in process Biohazard cautions Wear protective gloves to prevent exposure to pathogenic microbes 3 Biohazard cautions Wear protective gloves to prevent exposure to pathogenic microbes Caution Labels ...

Page 6: ... 1 4 3 First operation after setting up 1 4 4 Notes at transportation 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 C...

Page 7: ...standard range setting 3 4 Maintenance 3 5 Mode Menu 3 6 Built in Clock Adjustment 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 3 4 Replacement of ...

Page 8: ...C 07 SP 4430 ...

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Page 10: ...ON 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 Analyzer 1 4 1 Cautions 1 4 2 Setting up the analyzer 1 4 3 First operation after setting up 1 4 4 Notes at transportation SP 4430 1 01 ...

Page 11: ...ped 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 and setting it on the Centrifuge equipped Multi Rack the operation centrifugation suction sampling is conducted autom...

Page 12: ...ht transmitted by 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 SP 4430 1 03 1 1 SP 4430の概要 Chapter 1 INTRODUCTION 1 1 2 Measurement principles channel 1 channel 2 channel 3 channel 4 channel 5 channel 6 ch...

Page 13: ...color reaction Set for sach measurement item SPOTCHEMⅡReagent Strip 63 samples per hour 6 the number of measurement items 38μL serum plasma 4 6μL per 1 measurement item serum plasma Whole blood exclusive whole blood sample tube Orange cap Centrifuge tube Serum plasma exclusive serum sample tube Blue cap 3 Single Reagent Strips or 1 Multi Reagent Strip Maximum of 9 test items of continuous measurem...

Page 14: ...are included 4 Accessory case 5 Operating manual 6 Warranty card with case Delivery label 1 Analyzer S 4430 3 AC adapter 2 Power cord Description SP 4430 This book Warranty card with case Delivery label NO 1 2 3 4 5 6 Item Analyzer Power cord AC adapter Accessory case Operating manual Warranty card Qty 1 1 1 1 1 1set ...

Page 15: ...paper Description 10 tips Nozzle cleaning Brush Cotton swab Nozzle with O ring 2 Wrench Adapter 10 pieces 2 pieces 2 pieces width 58 mm NO 1 2 3 4 5 6 7 8 9 Item Tip Cleaning wire Cleaner set Nozzle set EZ Wrench set for nozzle replacement Centrifuge tube Tip waste case Protective cover Thermal printer papaer Qty 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set 1 Set Open the package and confirm th...

Page 16: ...The standard reflection plates used for measurement of reflectivity Prevents entering the external light Slide forward the Reagent Table and Centrifuge equipped Multi Rack to open For starting or stopping measurement and entering IDs Displays information such as operating state of the unit and error messages For inserting magnetic cards Reagent Card and Calibration Cards Thermal type printer Print...

Page 17: ...option Cancels entry Feeds the built in printer with paper while pressed Switches the page on each menu display 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 Determines the entry Check message to proceed to the operation Item START STOP FEED MENU 0 9 ten key hyphen period ENTER ...

Page 18: ...he analyzer For the supplied AC adapter For Ventilating heated air in the unit to prevent overheating For the cable of the optional external device Jack for the bar code reader option For adjusting screen contrast Turning clockwise to make the screen darker counterclockwise makes it brighter For setting thermal printer paper Item Power switch Power input terminal Cooling Fan COM B C R CONT Paper h...

Page 19: ...ble or modify the analyzer Such actions may invite danger of exposure to pathogenic microbes and cause fire or damage Place the analyzer on a stable and level surface free of vibration Failure to do so may damage the analyzer correct measurement results may not be obtained and injury may result Do NOT place the analyzer where there is a risk of falling To avoid electric shock and or fire use the a...

Page 20: ...nction of the analyzer To connect the analyzer to external devices be sure to use proper cables to avoid electric shock and or fire For details contact your distributor temperature 10 30 humidity 20 80 Place the analyzer in a room at temperatures between 10 and 30 with humidity between 20 and 80 Otherwise correct measurement results may not be obtained Make sure that the room is well ventilated wh...

Page 21: ... the fixing tape 1 Remove the tape fixing the table cover Open the maintenance cover and remove the tape fixing the nozzle Reattach the maintenance cover Connecting an external device if necessary 3 When using an external device connect the exclusive connecting cable to COM on the rear panel of the analyzer Connect the power cord 2 Make sure that the power switch on the rear of the analyzer is OFF...

Page 22: ...s shown at right For error correction or troubleshooting see Chapter 5 Troubleshooting S PO T CH EM E Z S Pー４４３０ V X X X X Wa r m i n g u p １ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ Set the thermal printer paper 2 Set the attached thermal printer paper See 4 3 1 Thermal printer paper replacement If the date is not set correctly correct measurement results may not be obtained and an erro...

Page 23: ...he table cover C o v e r i s c l o s i n g B a c k t o ME NU S T OP B a c k t o ME A S E N T E R C o v e r i s c l o s i n g S t o p S T OP 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 C...

Page 24: ...NU The Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack slide forward The Standby screen is displayed Make sure that there are no used Reagent Strips or samples If any discard them When there are used tips in the Tip Waste Case discard them Press STOP to return to the MAIN MENU and turn off the power switch Placing analyzer into carrying case 2 Place the analyzer AC adapt...

Page 25: ...C 1 16 SP 4430 ...

Page 26: ...b ...

Page 27: ...eparation 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 The normal measurement and two type...

Page 28: ...purpose 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 Multi Reagent Strip Item name Bar code 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 Single Reagent Strips Item nam...

Page 29: ...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 Normal measurement 2 1 測定を始める前に Chapter 2 MEASUREMENT ...

Page 30: ...ent 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 SPOTCHEM Calibrator Kit For use with all items except Hemoglobin SPOTCHEM Calibrator Hb Kit For use with Hemoglobin Each Calibrator Kit contains Low and High lyophilized serum and a Calibration Card For detailed procedures see t...

Page 31: ...e SP 4430 2 05 1 4 装置の設置 Chapter 2 MEASUREMENT 2 1 4 校正について The flowchart of calibration ...

Page 32: ... device it may damage Do NOT move the analyzer during measurement Such movement may cause malfunction resulting in incorrect measurement results If there is anything wrong with the analyzer or in case of odor or smoke turn OFF the power immediately and unplug Otherwise the analyzer may be damaged and cause fire If the analyzer is out of order contact your distributor for repair Do NOT attempt to r...

Page 33: ...of which the reagent fields show any sign of discoloration or deformation even if they are before the expiration date Otherwise correct measurement results may not be obtained 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 Open a reagent strip package immediately b...

Page 34: ...dable Do NOT use a magnetic card supplied with Reagent Strips or Calibrator for SP 4420 or SP 4430 with other devices The card may become jammed in the device Do NOT touch the pointed end of a Tip with bare hands If it becomes soiled correct sampling may not be possible resulting in incorrect measurement results Do NOT reuse a tip Water repellent treatment is applied to each tip so that the sample...

Page 35: ...ce 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 Heparin When it takes time before blood samples collected are brought into the centrifuge t...

Page 36: ...al Measurement Calibration by Magnetic Card or Calibration by Calibrator Preparation IMPORTANT Take the Reagent Strips out of the refrigerator and leave them at room temperature 10 30 for 20 minutes Single Reagent Strips Multi Reagent Strip Using Reagent Strips without allowing them to reach room temperature may result in incorrect measurement results IMPORTANT ...

Page 37: ...ppears during warm up as shown at the right and initialization and self check of each function are performed About 10 minutes after when at 25 warm up is completed and the MAIN MENU is displayed Warm up time depends on the room temperature S PO T CH EM E Z S Pー４４３０ V X X X X NOTE Before turning ON the power make sure that the maintenance cover is in position If light enters into the analyzer durin...

Page 38: ... no used samples in it If any discard them Install the Tip Waste Case Check each part before performing Normal Measurement or Calibration Setting the parameters 4 Set the parameters as necessary If the same parameter settings are continuously used resetting is not necessary See Chapter 3 SUB MENU for details Wear protective gloves to prevent exposure to pathogenic microbes WARNING Discard used sam...

Page 39: ...t items 38μL For example the required volume for 5 test items is 6 x 5 38μL 68μL A Serum or Whole blood Sample Tube has 2 lines marked on it for 100μL and 500μL Serum or plasma sample Prepare a Serum Sample Tube blue cap Pipette serum or plasma If measurement is not performed immediately cap the tube to prevent contamination or evaporation Serum sample tube Blue cap Whole blood Prepare a Whole blo...

Page 40: ...in Repeat the above procedure several times Even if the sample stays at the bottom after being inverted heparin is well mixed with the sample Do NOT shake the tube vigorously 1 2 3 4 Ensuring rotor balance Place sample tubes symmetrically against the rotation axis as illustrated at right For centrifugation of 1 or 5 samples use a dummy tube filled with an equal amount of water to make a total of 2...

Page 41: ... 2 4 1 Normal measurement 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 A Centrifuge tube has 1 line marked on it for 250μL The samples may coagulate when it takes time before the samples...

Page 42: ...ple several times see 2 14 Inverting a sample Prepare a Serum Sample Tube blue cap Pipette 200μL of distilled water Pipette 40 μL of the prepared whole blood sample into the above Serum Sample Tube Cap the tube tight Invert the sample several times again Whole blood sample tube Orange cap distilled water 200 Blue cap Serum sample tube distilled water 200 Remove any air bubbles or skin on the surfa...

Page 43: ...alance into consideration see page 2 14 Check if the supernatant is impure or there is any skin or not Removing the supernatant is not necessary Uncap the tube and place it directly in the sample rack Using HDL C Kits If HDL C reagent direct method is used for measurement this procedure is unnecessary Serum or plasma 100 Separation Reagent 100 Serum or plasma 100 Blue cap Serum sample tube Chapter...

Page 44: ...en is displayed as shown at the right Check the time and date 2 Make sure that the time and date on the Standby screen is correct If not set a correct time and date see 3 6 Built in Clock Adjustment START key can be used instead of 1 key S t a n d b y ２０００ー０６ー１０ I D １ I N F O ２１ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ Wear protective gloves to prevent exposure to pathogenic microbes WA...

Page 45: ...TOP key The Standby screen is restored Besides hyphen key 0 2 4 5 6 and 8 keys can be used in selecting items 0 initially displayed item 2 last item 4 previous item 6 next item 8 first item 5 first item of the Multi Reagent Strip 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 d...

Page 46: ...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 displayed To restore the MAIN MENU press STOP key When ENTER key is pressed the Table Cover opens and the Standby screen is restored Set measurement No or ID if necessary ID of up to 13 cha...

Page 47: ...d The registration can be made on the Parameter Menu The sample type set for basic type is established as an initial value No setting is needed when not changed Besides hyphen key 4 and 6 keys can be used in selecting sample type 4 previous sample type 6 next sample type Pressing Start key on the Sample type selecting screen starts measurement with the displayed sample type without returning to th...

Page 48: ...et a sample after removing the cap Uncap sample tubes and place them to the port of the multi rack Measurement of serum or plasma or centrifuged samples 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 become troubled and correct measurement results may not b...

Page 49: ...g sample amount is enough and perform remeasurement or additional measurement IMPORTANT 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 IMPORTANT Every time when 0 key is pressed on the Centrifugation selecting screen On and Off are displayed alternately Set the Multi ...

Page 50: ...he V shaped notch Open the aluminum foil package of a Reagent Strip by tearing straight down from the V shaped notch Place the Reagent Strips on the Reagent Table by holding the right side of the strip 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 be...

Page 51: ...ed The message Measuring is displayed After a while approximate remaining time is displayed The time displayed in changes at every 30 seconds Me a s u r i n g S t o p S T OP To discontinue the measurement press STOP key to return to the Standby screen 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 Str...

Page 52: ...ip Table and the Centrifuge equipped Multi Rack slide forward The Standby screen is restored Where measured results are not printed due to lack of printer paper press 5 key on the Standby screen to display the latest measurement results Press 5 key again to return the Standby screen P r i n t i n g S t a n d b y ２０００ー０６ー１０ I D １ I N F O ２ NOTE Only measurement item and its result are displayed Cha...

Page 53: ...tach the Tip Waste Case To discontinue measurement press STOP key to return to the MAIN MENU End measurement for the day 11 After finishing all measurement for the day perform daily maintenance see 4 2 Daily Maintenance NOTE The message DISCARD TIPS appears once every five measurements When the message is displayed discard the tips Otherwise a trouble may occur R emo v e u s e d t i p s OK E N T E...

Page 54: ...s for calibration with SP 4430 1 Calibration by magnetic card 2 Calibration by calibrator kit using an exclusive calibrator lit 1 calibration is performed by inserting a magnetic card Reagent card attached to each reagent strip into the magnetic card reader 2 calibration is performed using an exclusive calibrator This calibration should be performed every 6 months when the Reagent Lot is changed o...

Page 55: ...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 １ C A RD ２ C a l ３ I n f o r ma t i o n １１ Press STOP key to stop the calibration by magnetic card Insert Reagent Card 3 Press 1 key on the CALIBRATION MENU Insert either strip of a Single or Multi Card in the magnetic reader and slide the strip to t...

Page 56: ...When all stripes are inserted measurement item and lot numbers are displayed About 2 seconds after the Magnetic card entry screen will be displayed Calibration by magnetic card is completed Insert the same stripes twice to read the stored information in the magnetic cards End of calibration by magnetic card 4 When the discontinuing the calibration press STOP key 3 times to return to the MAIN MENU ...

Page 57: ...er parameters If the calibration type is already set for calibrator kit this operation is not necessary Prepare the reagent strip and calibrator 3 Prepare the required amount of Reagent Strips according to the following table When performing the calibration by calibrator kit using Multi Reagent Strips calibration mode of each measurement item single item attached to Multi Reagent Strip is used Wea...

Page 58: ...ow or High solution according to the instructions on the package insert included in the calibrator kit Place 500μL 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 Sー０１ GG T １３０ L H N ３ calibration card distilled water calibrator A B Serum sample tube blue cap 2 5 校正 Chapter 2 M...

Page 59: ...played The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi Rack slide forward The Calibration standby screen as shown on the right is displayed Insert the same stripes twice to surely read the stored information in the calibration cards There 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 alar...

Page 60: ... 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 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 IMPORTANT NOTE Be sure to remove the caps before calibration to avoid damage to the nozzle Be...

Page 61: ...his 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 With Multi type Reagent Strips 1 point calibration cannot be performed Calibration with Multi type Reagent Strips Prepare Multi type Reagent Strips Prepare twice as many Multi type Reagent Strips as the number of the times calibration th...

Page 62: ...time changes to the ordinary time indication The disappears and 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...

Page 63: ...Table and Centrifuge equipped Multi Rack slide forward The Calibration standby screen is restored Remove the used Reagent Strips and samples and discard them Press STOP key to stop calibration The Calibration standby screen is restored Set the High Calibrator 10 Set the High Calibrator by following procedure 6 Set the Reagent Strips 11 Set the Reagent Strips by following procedure 7 Measure the Hi...

Page 64: ...isplayed remove the Tip Waste Case and discard used tips Set the Tip Waste Case again R emo v e u s e d t i p s OK E N T E R NOTE The message Remove used tips is displayed every 5 measurements When this message is displayed discard the used tips If measurement is continued it may cause trouble ...

Page 65: ...wing additional items to the print out of the Normal mode These items are printed out when the Survey Mode is ON Measurement value which temperature conversion unit conversion or correlation correction is not applied Information on temperature conversion temperature and temperature conversion factor Information on unit conversion unit and unit conversion factor Information on correlation correctio...

Page 66: ...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 mark is printed when the measurement result is higher than the upper limit of the standard range ex T Pro mark is printed when the measurement result is lower than the lowe...

Page 67: ... than enzyme items Temperature conversion factor Conversion factor when the standard temperature is 37 Unit mg is the conventional unit SI is SI unit and User is units set by users Unit conversion factor Conversion factor when the conventional unit is standard Coefficient of correlation correction Coefficient set in the Entering parameters on the Sub Menu 1 2 3 4 5 6 Generally mg conventional unit...

Page 68: ...ngle Reagent Strip Version Calibration date The date when START key was pressed for the first time From the left name of Multi Reagent Strip item symbol lot number and expiry date Lot no of the calibrator Read by the calibration card Displayed value of calibrator Read by the calibration card Measurement value when calibration is not performed Printed out for the number of calibration times Average...

Page 69: ...ulti Reagent Strip 1 2 From the left name of Multi Reagent Strip item symbol lot number and expiry date 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 1 2 SP 4430 2 43 ...

Page 70: ...C 2 44 SP 4430 ...

Page 71: ...b ...

Page 72: ...B MENU 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 parameters 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 Adjustmen...

Page 73: ...MENU are available SUB MENU 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 When START key is pressed on any screen of SUB MENU the MAIN MENU is restored 3 1 1 Composition of SUB...

Page 74: ...C SP 4430 3 03 1 4 装置の設置 Chapter 3 SUB MENU 1 4 3 設設置後の始動と終了 ...

Page 75: ...ed Select measurement results to print 2 Press 1 key 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 t...

Page 76: ...surements 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 resu...

Page 77: ...n to the Measurement result selecting screen Display setting screen 1 Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Press 1 key The MEASUREMENT RESULTS MENU is displayed Select measurement results to transmit 2 Press 2 key The Select Results screen is displayed Select the measurement results to transmit by using numeric keys 1 LATEST the latest measurement result 1 measurement 2 ALL all m...

Page 78: ... screen is restored If designation of the range of measurement dates the dates of starting and 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 2000 2089 90 99 1990 1999 Se...

Page 79: ... screen is displayed Press START or STOP If START key is pressed the measurement results are deleted and the MEASUREMENT RESULTS MENU is restored If STOP key is pressed deletion is canceled and the MEASUREMENT RESULTS MENU is restored End Deletion 3 Press STOP key three times to return to the MAIN MENU P a s s w o r d C a n c e l S T OP D e l e t e Y e s S T A R T N o S T OP １ R e s u l t s ２ P A ...

Page 80: ...ls Meaning 5 character ID ending with M 5 character ID starting with AB and ending with YZ ID starting with AB and ending with YZ ID including PQR ID of 4 characters or more starting with N Example 1 Example 2 Example 3 Example 4 Example 5 Searching Pattern M A B Y Z A B Y Z P Q R N This function is upper lower case sensitive The characters key or themselves cannot be searched for e g To search ID...

Page 81: ... is restored End Printing 3 Press STOP key to return to the MAIN MENU Besides hyphen key 0 2 4 5 6 and 8 keys can be used in selecting items 0 initially displayed item 2 last item 4 previous item 6 next item 8 first item 5 first item of the Multi Reagent Strip If ALL SINGLE or ALL MULTI is selected parameter settings of all the items for Single or Multi Regent Strips are printed out respectively T...

Page 82: ...alculates Temperature Printed out as for the items other than enzyme items Coefficient of correlation correction Coefficient set in the Entering parameters in the SUB MENU Measurement range The lower limit and upper limit Standard range The lower limit and upper limit Sample types The lower limit and upper limit of standard range for each sample types set Printing is available only when sample typ...

Page 83: ...bol lot number and expiry date Calibration type CARD means calibration by magnetic card and Cal means calibration by calibrator kit Calibration factor Coefficient of system s difference correction Coefficient to use in the measurement calculates 1 2 3 4 The lot number and calibration date are printed only when calibration by calibrator kit was performed ...

Page 84: ...ment results are printed or is added on data out of the standard range When sample type is set its corresponding standard range is applied Calibration Conditions Set the type calibrator or magnetic card and the number of times of calibration for each measurement item 1 4 装置の設置 3 3 2 Enter parameters If STOP key is pressed during entry the entry is canceled and the cursor returns to the previous or...

Page 85: ...ng screen is displayed Besides hyphen key 0 2 4 5 6 and 8 keys can be used in selecting items 0 initially displayed item 2 last item 4 previous item 6 next item 8 first item 5 first item of the Multi Reagent Strip To enter minus signs and decimal points use key If key is pressed first a minus sign is entered To enter a decimal point press key after any number is entered e g To enter 12 Press 1 2 e...

Page 86: ...T A R T N o S T OP Enter the lower limit value of the standard range for the sample type1 Press Enter key to move the cursor to a place for the upper limit value Enter the upper limit value with the numeric keys and press Enter key Similarly set the standard range for sample types 2 to 5 The Entry check screen is displayed When sample type is set S a v e Y e s S T A R T N o S T OP Ｍａｎ L １０ Sー０１ H ...

Page 87: ...ings 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 End setting 8 If the setting is finished press STOP key three times to return to the MAIN MENU W r i t i n g Sー０１ GG T １３０１ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ ...

Page 88: ...RT key is pressed parameters are initialized and the Measurement item selecting screen is restored If STOP key is pressed initialization is canceled and the Measurement item selecting screen is restored Besides hyphen key 0 2 4 5 6 and 8 keys can be used in selecting items 0 initially displayed item 2 last item 4 previous item 6 next item 8 first item 5 first item of the Multi Reagent Strip If ALL...

Page 89: ...1 4 装置の設置 3 3 2 パラメータ設定 End Initialization 3 If the initialization is finished press STOP key three times to return to the MAIN MENU １ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ 25 30 37 a 0 10000 b 10000 10000 L 0 10000 H 10000 10000 type Number of times Setting item and range Temperature Coefficient of correlation Standard range Calibration Factory setting value 37 a 1 0 b 0 0 Measuremen...

Page 90: ... using numbers letters and symbols Press Enter key The Sample type 2 name entering screen is displayed Similarly enter the sample types 2 to 5 When no sample type is set press Enter key with the space kept blank The numeric keys and keys can be used in selecting items For example to entry man 6 6 2 2 2 2 6 6 6 6 6 6 0 key can be used to input the following 12 symbols which are To delete the name p...

Page 91: ...s the basic setting and press Enter key The Entry check screen is displayed Saving the setting contents 4 Press Start key or Stop key Pressing Start key saves the details 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 ＲＥＦｖａｌｕｅｂａｓｅｔｙｐｅＭａｎ S a v e Y e s S T A R T N o S T OP End setting ...

Page 92: ...ample 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 Selecting the standard range on the original screen 2 Press key to select the sample type for which the standard range is set on the original screen Press Enter key The cursor moves to the sample type on the duplicate screen １ R e s u l t s ２ P A R AM ３ Ma i n t e n a...

Page 93: ...n is displayed Saving the setting contents 4 Press Start key or Stop key Press Start key to copy and save the 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 range S a v e Y e s S T A R T N o S T OP End setting 5 Press STOP key twice to return to the MAIN MENU W r i t i n g ＰＲＥＳＳＰＣＮｅｘｔＳＰＣＭａｎＷｏｍａｎ ...

Page 94: ...ipped Multi rack slide forward When the message is displayed as shown on the right turn off the power Perform maintenance 2 Perform maintenance of each part see Chapter 4 MAINTENANCE End maintenance 3 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 After the warm up is completed MAIN MENU is re...

Page 95: ...2 6 Interpreting measurement results for details of printouts The Survey Mode is canceled automatically when the power is turned off Switch to the Survey Mode 2 Press hyphen key Turn ON the Survey Mode Press ENTER key The message Writing is displayed and the MODE MENU is restored End the Survey Mode 3 If the setting is finished press STOP key three times to return to the MAIN MENU １ S u r v e y １ ...

Page 96: ...U Chapter 3 SUB MENU 3 6 Built in Clock Adjustment 3 3 2 パラメータ設定 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 Display setting screen 1 Press 2 key on the MAIN MENU SUB MENU1 2 is displayed D a t e ００ー０６ー０１ YMD T i me １２３４００ P a s s w o r d C a n c e l S T OP D a t e ００ー０６ー１２ YMD T i ...

Page 97: ...C 3 26 SP 4430 ...

Page 98: ...b ...

Page 99: ...es Chapter 4 MAINTENANCE 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 3 4 Replacement of Nozzle ...

Page 100: ...intenance Perform daily or periodical maintenance according to the table Frequency Daily Daily When a red line appears on both sides of printer paper Once every 2 000 measurements Once every 10 000 measurements or once a year When a trouble occurs or once a year Page 4 03 4 06 4 07 4 08 4 10 4 13 4 16 Cleaning of the parts marked with on the table above requires user to wear protective gloves to p...

Page 101: ...if necessary Slide the Reagent Table forward 1 Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Press 3 key The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi Rack slide forward Turn OFF the power Clean the Reagent Table 2 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 malfunct...

Page 102: ... swab Clean the black and white plates Clean the Rubber Plate Once a week 3 Remove the top cover by sliding it to the left Cleaning the black and white plates once a week NOTE The black and white plates are reflectors 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...

Page 103: ...al position and the Table Cover closes If the operation is completed turn OFF the power after the MAIN MENU is displayed Wa r m i n g u p １ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ 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 ...

Page 104: ... displayed Press 3 key The Table Cover opens and the Reagent Table and the Centrifuge equipped Multi Rack slide forward Turn OFF the power Discard Tips 2 Remove the Tip Waste Case from the Centrifuge equipped Multi Rack Discard tips Requirements Alcohol Cloth and Protective gloves Wear protective gloves to prevent exposure to pathogenic microbes WARNING Discard used samples tips and protective glo...

Page 105: ...quipped Multi Rack End cleaning 6 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 If the operation is completed turn OFF the power after the MAIN MENU is displayed Disinfect and wash the Protective Cover 5 Disinfect the Protective Cover with alcohol and wash it with tap water Wipe it dry with a clo...

Page 106: ... out on one roll of paper Cut printer paper 1 Make sure that the MAIN MENU is displayed Open the printer cover If paper remains in 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 Remove the remained paper 2 Press the FEED key Pick and remove the remained paper as it is fed out Requirements New thermal ...

Page 107: ... 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 Close the printer cover 5 Close the printer cover until it clicks into place NOTE Be careful not to touch the paper cutter to avoid injury To make the printer ready for printi...

Page 108: ...zer Turn OFF the power Lay the analyzer on its side 2 Remove the Tip Waste Case from the Centrifuge equipped Multi Rack Requirements Cotton swab Distilled water and Protective gloves Wear protective gloves to prevent exposure to pathogenic microbes WARNING Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste CAUTION １ R ...

Page 109: ...ver while turning the analyzer 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 NOTE Do NOT damage the connecting part of the...

Page 110: ...ck 4 3 定期的なお手入れ Chapter 4 MAINTENANCE 4 3 2 測光窓の清掃 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 When the operation is completed turn OFF the power after the MAIN MENU is displayed NOTE Do NOT damage the connecting part of the Table Cover Be careful not to tip over the analyzer to avoid damage Wa...

Page 111: ...slide forward The Nozzle Driving Unit moves to the left end in the analyzer Turn OFF the power Requirements Nozzle cleaning wire Tweezers Tissue paper and Protective gloves Wear protective gloves to prevent exposure to pathogenic microbes WARNING Discard used samples tips and protective gloves separately from general waste according to local regulations on biohazardous waste CAUTION １ R e s u l t ...

Page 112: ...aning 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 4 3 定期的なお手入れ Chapter 4 MAINTENANCE 4 3 2 測光窓の清掃 Remove the side cover NOTE Do NOT scratch or damage the Nozzle Tube ...

Page 113: ... 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 Insert the Nozzle Tube 5 Remove the nozzle cleaning wire from the Nozzle Pinch the Nozzle Tube with tweezers and insert it into the tube joint Wa r m i n g u p １ Me a s u r e ２ S u bme n u ３ C a l i b r a t e １１ NOTE Before turning ON the p...

Page 114: ...e according to local regulations on biohazardous waste CAUTION Move the Nozzle to stand by position 1 Press 2 key on the MAIN MENU SUB MENU 1 2 is displayed Press 3 key The Table Cover opens and the Reagent Table and Centrifuge equipped Multi Rack slide forward The Nozzle Driving Unit moves to the left end in the analyzer Turn OFF the power １ R e s u l t s ２ P A R AM ３ Ma i n t e n a n c e １２１ M...

Page 115: ... remove the tip ejector Remove the Tip Waste Case Replace the Nozzle 4 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 the wrench Attach a new Nozzle and fasten it lightly by hand Tighten it firmly using two wrenches Remove the side cover ...

Page 116: ... the Tip Waste Case by tightening the screws 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 When the operation is completed turn OFF the power after the MAIN MENU is displayed 1 2 NOTE Before turning ON the power make sure that the maintenance cover is installed Wa r m i n g u p １ Me a s u r e ２ S...

Page 117: ...b ...

Page 118: ...ror Messages 5 2 Trouble Messages 5 3 After sales service SP 4430 5 01 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 ...

Page 119: ...s occurred during measurement Power was turned off during measurement The power cable was unplugged during measurement The last measurement was invalid Restart measurement E03 Ｅ０３ＰｏｗｅｒｄｏｗｎＯＫＥＮＴＥＲ A light source is deteriorated If the same trouble occurs contact your distributor E04 Ｅ０４ＬＥＤｕｎｓｔａｂｌｅＯＫＥＮＴＥＲ The white and black plate or window plate is dirty Clean the white and black plate or w...

Page 120: ...pe 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 A multi car...

Page 121: ... card was used a calibration card was inserted when the display showed Reagent Card reading or vice versa Insert a correct magnetic card E24 Ｅ２４ＷｒｏｎｇｃａｒｄＯＫＥＮＴＥＲ The same stripe was inserted Insert a different stripe E25 Ｅ２５ＷｒｏｎｇｓｔｒｉｐｅＯＫＥＮＴＥＲ During calibration the difference of the measured value and the display of calibrator is extremely large The variations of the measured values are ext...

Page 122: ...was not correctly read due to displacement or bending of the Reagent Strip Foreign matter is attached to the Single Reagent Strip Remove dust from the table Reset the Single Reagent Strip correctly Confirm that foreign matter is not attached to the Single Reagent Strip E34 Ｅ３４ＢＡＲｍｉｓｒｅａｄ９８７ＯＫＥＮＴＥＲ The setting such as baud rate of the hand held bar code reader is incorrect The hand held bar cod...

Page 123: ...d The setting e g baud rate of the connected device such as PC is incorrect Connect the cable correctly Confirm the setting e g baud rate of analyzer connections e g PC E39 Ｅ３９ＣｏｍｍｕｎｉｃａｔｉｏｎＯＫＥＮＴＥＲ Forgot to set the Tip Waste Case The Tip Waste Case is not correctly set Set the Tip Waste Case correctly E38 Ｅ３８ＴｉｐｃａｓｅｎｏｔｓｅｔＯＫＥＮＴＥＲ When sampling air bubbles or fibrin was aspirated When sampl...

Page 124: ...he measurement cannot be started T04 Ｔ０４ＴｅｍｐｃｏｎｔｒｏｌＯＫＥＮＴＥＲ 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 If the same trouble occurs contact your distributor T05 Ｔ０５ＮｏｚｚｌｅＵＤＯＫＥＮＴＥＲ Trouble occurred in the nozzle right left driving Turn on...

Page 125: ...d though trouble is detected when the power turned on trouble occurs at the start of measurement and the measurement cannot be performed T12 Ｔ１２ＯｐｔｉｃａｌｇａｉｎＯＫＥＮＴＥＲ Trouble occurred in the internal calculation operation If the same trouble occurs contact your distributor T13 Ｔ１３ＣａｌｃｕｌａｔｉｏｎＯＫＥＮＴＥＲ LED is not lit LED is deteriorated Turn on the power again If the same trouble occurs contact you...

Page 126: ...cover properly T27 Ｔ２７ＣｅｎｔｒｉｆｕｇｅＯＫＥＮＴＥＲ Trouble occurred in the centrifuge front back driving mechanism It cannot operate because of an obstruction in the operating path of the centrifuge base Turn on the power again Confirm that there is no obstruction If the same trouble occurs contact your distributor T28 Ｔ２８ＣｅｎｔｒｉｆｕｇｅＦＢＯＫＥＮＴＥＲ Trouble with product information memory storage Power was c...

Page 127: ... type The parameter item number found defective in either case Description and trouble message Conditions and causes Remedy Trouble with parameter memory storage Power was cut while writing in memory or deleting If the same trouble occurs contact your distributor T93 Ｔ９３ＭｅｍｏｒｙｐａｒａｍｅｔｅｒＳ０３ＯＫＥＮＴＥＲ ...

Page 128: ...n the analyzer requires repair After filling in the necessary items and confirming the described contents keep the warranty in a safe place Repairs When the analyzer does not function well Repair within the guaranteed period Repair after the guarantee has expired Contact your distributor Repair is made under conditions of the certificate A repair fee is necessary ...

Page 129: ...b 5 12 SP 4430 Chapter 5 TROUBLESHOOTING ...

Page 130: ...b ...

Page 131: ...b SP 4430 6 01 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 ...

Page 132: ...s 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 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 ETX or ETB to STX Data transmission is sometimes forced to stop h...

Page 133: ...s Data Data text of each block is the main body of transmission contents and is expressed by arrangement of ASCII characters CR LF RS or US is sometimes involved in data Characters other than these cannot be involved End E End of each block is RTX or ETB ETX or ETB is distinguished by whether it is in the last block or not If it is in the last block it is ETX and if it is in the middle block it is...

Page 134: ...Single Reagent Strip measurement results E C When Multi and Single Reagent Strips are measured S Header E Multi Reagent Strip measurement results Single Reagent Strip measurement results S E Format of header 001 002 003 004 005 006 007 008 009 010 011 012 013 014 015 016 017 018 019 020 021 022 CR LF 023 024 025 026 027 028 029 030 031 032 033 034 035 036 037 038 039 040 041 042 043 044 ＩＤ CR LF ...

Page 135: ...80 102 124 146 015 037 059 081 103 125 147 016 038 060 082 104 126 148 017 039 061 083 105 127 149 018 040 062 084 106 128 150 019 041 063 085 107 129 151 020 042 064 086 108 130 152 021 CR 043 CR 065 CR 087 CR 109 CR 131 CR 153 CR 022 LF 044 LF 066 LF 088 LF 110 LF 132 LF 154 LF Start 008 023 Description Finish 017 027 Name of Multi Reagent Strip Item name Abnormal mark Within the range of standa...

Page 136: ...066 LF 088 LF Start 001 Description Finish 007 When only Single Reagent Strips are measured Blank 20H When Multi Reagent Strips are measured Fixed character string SINGLE Item name Abnormal mark Within the range of standard values Blank 20H Low value US 1FH High value RS 1EH 023 027 Measurement value 030 034 Unit symbol 036 041 029 029 Temperature 37 Blank 20H 30 25 Items other than enzyme Blank 0...

Page 137: ... OVER Upper limit of measurement range 037 041 Temperature 37 Blank 20H 30 25 Items other than enzyme Blank 042 042 Prozone CANT MEAS or calibration error by magnetic card 023 024 025 026 027 028 029 030 031 032 033 034 035 036 037 038 039 040 041 042 043 CR 044 LF Start 023 Description Finish 027 Item name Error message Prozone CANT MEAS CANT MEAS Magnetic card CAL error L CAL ERROR L1 Magnetic c...

Page 138: ...The maximum number of items in the measurement 014 015 The order of the maximum number of items 017 018 Measurement date Year The last two digits of year month 1 12 date 1 31 No zero control YMD format is always applied regardless of the date setting 020 027 Measurement date Time 0 23 Minute 0 59 No zero control 029 033 Data error Normal 0 Under the range 1 Over the range or prozone error OVER 2 L...

Page 139: ...b 83 00139F ...

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