Arkray SpotChem D-Concept 2c Operating Manual
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Arkray SpotChem D-Concept 2c Operating Manual

Arkray SpotChem D-Concept 2c Operating Manual

Automated dry chemistry system
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  • Page 2: Intended Purpose

    Premise Thank you for purchasing our measurement unit for the automated dry chemistry system, the SpotChem D-Concept 2c SD-4830. This manual contains important information on the functions of the SpotChem D-Concept 2c SD-4830. This manual is issued by ARKRAY, Inc.
  • Page 3 ● Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 1 m (40 inches) to any part of the SpotChem D-Concept 2c SD-4830, including cables specified by the manufacturer. Otherwise, degradation of the performance of this instrument could result.

  • Page 4: Introduction

    Introduction Read this instrument operating manual thoroughly before using the instrument. This instrument operating manual gives an overview of the instrument and the proper procedures for operation and maintenance. Follow the instructions in this instrument operating manual in order not to defeat the purpose of the protective features of the instrument.
  • Page 5 • The information in this instrument operating manual is subject to change without notice. • ARKRAY, Inc. has made every effort to prepare this instrument operating manual as best possible. Should you discover anything strange, incorrect or missing, contact your distributor.

  • Page 6: Symbols

    Symbols The following symbols are used in this instrument operating manual and labels on this instrument to call your attention to specific items. For Your Safety Follow the instructions given here to prevent exposure to pathogenic microbes. Follow the instructions given here to prevent injury and property damage. For Optimal Performance IMPORTANT: Follow the instructions given here to obtain accurate measurement results.

  • Page 7: Warning And Caution Labels

    Warning and Caution Labels This instrument has several warning and caution labels on the areas that have potential dangers. Please learn potential dangers warned by each label and observe the precautions described below. Front Side a Inside of the unit Do not touch the inside of the unit or insert foreign bodies into the inside of the unit.
  • Page 8 Centrifuge Do not touch the centrifuge with unprotected hands. When cleaning or maintaining the unit, or setting the centrifuge cup, wear protective gloves to prevent exposure to pathogenic microbes. Centrifuge If the centrifuge cover has a crack, do not use the centrifuge. When the centrifuge retracts, the centrifuge cover automatically closes.
  • Page 9 Inside of the Unit Nozzle maintenance holder Do not touch the nozzle maintenance holder with unprotected hands. During cleaning or maintenance of the nozzle maintenance holder, wear protective gloves to prevent exposure to pathogenic microbes. SD-4830 viii...

  • Page 10: Table Of Contents

    Table of Contents Premise....................i Introduction..................iii Symbols....................v Warning and Caution Labels ............vi Table of Contents................ix Chapter 1 Before Use..............1-1 1-1 Overview..................1-1 1-1-1 Features ................1-1 1-1-2 Specifications ............... 1-2 1-1-3 Measurement Principle............1-3 1-2 Unpacking ..................1-5 1-2-1 Instrument................
  • Page 11 Chapter 2 Measurement ............2-1 2-1 Before Measurement ..............2-1 2-1-1 Lot Calibration ..............2-1 2-1-2 When Using the Centrifuge ..........2-1 2-1-3 Measurement Procedures ............ 2-2 2-1-4 Simple Mode................. 2-3 2-2 Measurement Preparations ............2-4 2-2-1 Instrument Checks..............2-4 2-2-2 Preparing the Sample............
  • Page 12 Chapter 5 Appendix ..............5-1 5-1 Patient Type ..................5-1 5-2 Computation Items ................. 5-5 5-3 Simple Mode Measurement Settings ..........5-6 Chapter 6 Index ................. 6-1 SD-4830...
  • Page 13 SD-4830...

  • Page 14: Chapter 1 Before Use

    Before Use Chapter 1 This chapter describes basic information about taking measurements and the operation of the instrument components. Overview 1-1-1 Features ● Operation via mobile devices The operation application on your mobile device allows for instrument operation, measurement result checking, quality control, etc.

  • Page 15: Specifications

    1-1-2 Specifications SpotChem D-Concept 2c (SD-4830) Name Configuration Instrument, accessories Measurement objects Serum, Plasma, Whole blood Reagent SPOTCHEM D single reagent SPOTCHEM D multiple reagent Measurement parameter Listed in package insert of reagent Measurement range Listed in package insert of reagent...

  • Page 16: Measurement Principle

    Weight Approximately 10 kg Supply voltage AC 100 to 240 V, ±10%, 50/60 Hz Power input 200 VA or less Location of use Indoor use only Altitude 3000 m Pollution degree Over voltage category Expected life 5 years (according to company data)*1 1-1-3 Measurement Principle ■...
  • Page 17 At the photometric sections of each measurement CH, the monochromatic light output from the optical fiber shines on the reagent pad to which a sample is dispensed and reacted and the reflected light is read by two photodiodes. The read reflected light is numerically converted by the A/D converter and used for computations.

  • Page 18: Unpacking

    Unpacking The following items are included with this instrument. Check that all of these items are included. If any items are missing or defective, contact your distributor. 1-2-1 Instrument Items included Description Quantity SpotChem D-Concept 2c Instrument SD-4830...

  • Page 19: Accessories

    1-2-2 Accessories AC adapter Power cord Operating manual Mobile device USB Type-C cable Handheld barcode reader (HCR) Blower brush Nozzle set Wrench set for replacing nozzle Cleaning wire Nozzle tube Cleaning kit Tip case Disposal case Centrifuge cover Hexagonal wrench Maintenance cover SD-4830...
  • Page 20 Item No. Items included Description Quantity Rating: 125 V 13 A (A Type Plug) and 250 V 10 A (C Type Plug) Please use the appropriate power cord for your region's power voltage. Operating manual e l i Nozzle set 1 nozzle with O-ring Wrench set for replacing nozzle 2 wrenches, 1 adapter...

  • Page 21: Part Names And Functions

    Part Names and Functions 1-3-1 Front Side of Instrument Name Function Front cover Prevents incoming ambient light. Opens when the reagent table and centrifuge extend toward you. Maintenance cover Can be opened to clean or replace the nozzle. Status indication LED Indicates the operation status of the instrument.

  • Page 22: Rear Side Of Instrument

    Name Function Printer connection Not connected: Off status LED Abnormal status: Blinking Connected: On Start button Press this button to start measurement. Stop button Press this button to cancel measurement. Power button Used to start and shut down the instrument. Tip case Used to set the measurement tips and cuvette.

  • Page 23: Bottom Of Instrument

    1-3-3 Bottom of Instrument Name Function Photometric section Open this cover for cleaning the photometric window. cover SD-4830 1-10...

  • Page 24: Installation

    Installation 1-4-1 Precautions for Installation ● Install the instrument under the supervision of a serviceperson. ● For safety reasons, always transport the instrument with both hands holding the bottom of the instrument. When setting down the instrument, be careful not to get your hands trapped underneath it. ●...

  • Page 25: Precautions For Moving The Instrument

    IMPORTANT: To obtain accurate measurement results, install the instrument in the following environment: • Low temperature fluctuation, adjustable from 10 to 30 °C. • Humidity can be controlled between 20 to 80%. • No condensation occurs inside the instrument. • There is no splash of water or other liquid. •...

  • Page 26: Before Installing The Instrument

    1-4-3 Before Installing the Instrument Before installing the instrument, remove any fixtures on the parts of the instrument. aThree pieces of fixing tape bNozzle fixture cMaintenance cover dCentrifuge fixture dReagent table fixture eReagent table fixture a Remove the two pieces of fixing tape on the front cover. b Remove the thumb screws securing the nozzle unit.

  • Page 27: Connecting Peripheral Devices (When Necessary)

    Connect a handheld barcode reader (USB Type-A), USB memory stick (USB Type-A), charging cable (USB Type C), and RS-232C cross cable, as necessary. ● Use the cable specified by ARKRAY when connecting the instrument to a hospital system. Using any cable other than the specified one may cause electric shock and fire.

  • Page 28: Turning The Power On

    1-4-6 Turning the Power On NOTE: Check the following before pressing the button. • Check that the maintenance cover is attached. If the maintenance cover is not attached, an E-104 error occurs. • Check that the area in front of the front cover is clear. The front cover of the instrument may open during the startup process and any objects placed in front of the front cover may interfere with operations.

  • Page 29: Measurement Precautions

    Measurement Precautions This section describes the measurement precautions. Before using this instrument for the first time, be sure to read all the precautions listed here. 1-5-1 Precautions for Operation ● This instrument is to be operated by qualified persons only. A qualified person is one having adequate knowledge of clinical testing and the disposal of infectious waste.

  • Page 30: Precautions For Handling Samples

    1-5-2 Precautions for Handling Samples ● TAKE THE UTMOST CARE WHEN HANDLING BLOOD. This system uses blood as sample. Blood may be contaminated by pathogenic microbes that can cause infectious diseases. Improper handling of blood may cause infection to the user or other individuals by pathogenic microbes. ●...

  • Page 31: Precautions For Handling Tips

    1-5-4 Precautions for Handling Tips ● Use the tip designed for this instrument. Using an undesignated tip may prevent accurate measurement and cause damage to the instrument. ● Do not touch the tip end with unprotected hands. Do not touch the tip end with unprotected hands. The tip end may become dirty and consequently lead to incorrect measurement results.

  • Page 32: Operation Application

    Operation Application The operation application installed on the mobile device mainly allows you to perform the following operations and settings. The operation application can connect up to 8 instruments simultaneously. For more details, see the Application Manual. ● Parameter settings ●...

  • Page 33: Chapter 2 Measurement

    Measurement Chapter 2 This chapter describes the methods for normal measurement and calibration. Before Measurement This section explains what you need to know before you begin measurements with this instrument. 2-1-1 Lot Calibration 2D code (Reagent Info.) is printed on the product box of a reagent. When you use a reagent of a new lot, scan the 2D code with the mobile device or the handheld barcode reader connected to the instrument to input the reagent lot information and automatically calibrate the lot-to-lot difference and variation per day.

  • Page 34: Measurement Procedures

    2-1-3 Measurement Procedures The measurement procedures are shown in the following flowchart. Instrument startup Press the button. Confirm that the instrument is ready by checking the status indication LED. Pre-measurement checks Perform as necessary before measurement. Enter the measurement number and sample ID. Set the sample type and patient type.

  • Page 35: Simple Mode

    2-1-4 Simple Mode This instrument can perform measurements in simple mode (simple measurement function) even when the operation application is not available. ● Conditions to enter simple mode Measurement is performed in simple mode in the following cases. • No connection is established with the operation application. •...

  • Page 36: Measurement Preparations

    Measurement Preparations This section explains the preparations required prior to measurement. 2-2-1 Instrument Checks This explains the items to be checked after the instrument has started. ■ Check the Printing Paper (When Using the Optional Printer) Check that there is sufficient printing paper in the printer. If both ends of the paper have a red line, replace the printing paper.
  • Page 37 IMPORTANT: When using the centrifuge cup, make sure that the sample level is between the lower and upper limits of the cup. If the sample is too much or too short, the centrifuge will not rotate correctly and may cause a trouble or damage. It may affect the measurement results of other instruments.

  • Page 38: Preparing The Reagent

    2-2-3 Preparing the Reagent This instrument uses SPOTCHEM D reagents sold separately. This instrument uses two types of SPOTCHEM D reagents. Use the type of reagent that best matches your measurement needs. ■ Single Reagent You can measure one item per reagent. Reagent pad Barcode Reagent name...

  • Page 39: Measurement

    Measurement You can measure a maximum of 12 items at a time for each sample using a SPOTCHEM D single/ multiple reagent. ● Wear protective gloves to prevent exposure to pathogenic microbes. ● For disinfection of the device, lightly wipe the disinfecting area with a cotton swab or gauze moistened with a disinfectant, then wipe the disinfectant with a cotton swab or gauze moistened with water, and then wipe it dry.
  • Page 40 Place the tips in the instrument a Press the button. The front cover opens and the reagent table and centrifuge extend toward you. b Remove the tip case. REFERENCE: When measuring for the first time after installing the instrument, set the tip case and disposal case in the accessory case in the instrument before measurement.
  • Page 41 When Using the Centrifuge ■ a Open the centrifuge cover, and set the centrifuge cup containing the sample in the centrifuge with the cap removed. After setting the centrifuge cup, close the centrifuge cover. NOTE: Placing the centrifuge cup in the centrifuge without first removing the cap will cause the nozzle to break.
  • Page 42 b Return the tip case to its original position. NOTE: Insert the tip case fully to the back of the instrument. Place the single/multiple reagent in the instrument a Open the foil pack of the single/multiple reagent as shown below. Hold the ends Tear open the and pull open.
  • Page 43 c Place the single/multiple reagent on the reagent table as shown below. IMPORTANT: Insert the end of a single/multiple reagent strip into the opening at the end of the groove on the reagent table and then fit the entire strip in the groove. If the single/multiple reagent strip is warped and/or not fitting on the groove, it may become jammed inside the instrument or lead to inaccurate results.
  • Page 44 Dispose of the used tips, samples and reagents NOTE: Each time after using 10 tips, a message is displayed after measurement is completed. You can change the number of tips for displaying the message. For more details, see the Application Manual. a Remove the disposal case and dispose of all used tips.

  • Page 45: Viewing The Measurement Result

    Viewing the Measurement Result When using the optional printer, the measurement result is printed. *To check the measurement results on the operation application, see the Application Manual. 2-4-1 Measurement Results This section explains how to read the printed measurement result. [Print example] SD-4830 2-13...
  • Page 46 Item Description Measurement date Indicates the measurement date and time. If the measurement is performed in simple mode, “#Results#” is printed instead of “Results”. Operator ID Indicates the ID of the person who performed the measurement, entered in the measurement conditions. You can set On/Off for printing this item.

  • Page 47: Survey Mode Measurement Result

    Item Description Converted item name and Only converted items are printed. measurement result Indicates the conversion result of each item. The following abnormal value marks are printed depending on the measurement value. ▲: The value is higher than the normal range ▼: The value is lower than the normal range OVER: The value is higher than the measurable range UNDER: The value is lower than the measurable range...

  • Page 48: Printing Troubles

    2-4-3 Printing Troubles This section explains how to read the printed error and trouble information. [Print example] Item Description Information about the error/ 1st line: Prints the error/trouble number and error name. trouble that has occurred 2nd line: Prints the additional information (only when there is additional information).

  • Page 49: Chapter 3 Management Operation

    Management Operation Chapter 3 This chapter describes the settings available on the menu screen, maintenance, quality control, and reagent information setting. Settings Available on Operation Application The following operations are available on the operation application. For more details, see the Application Manual.

  • Page 50: Maintenance

    Maintenance This section explains the maintenance items. Wear protective gloves to prevent exposure to pathogenic microbes. 70% isopropyl alcohol is sometimes used to clean the instrument. 70% isopropyl alcohol is readily combustible, therefore handle it carefully and keep away from flames, electrical sparks and sources of heat. Also, ventilate the room sufficiently during use.
  • Page 51 ■ Daily Cleaning Prepare: Cotton swab, distilled water, soft cloth, blower brush, 70% isopropyl alcohol and protective gloves Prepare for daily cleaning a Select “Daily cleaning” from the maintenance menu of the operation application and start the process. b The front cover opens and the reagent table and centrifuge extend.
  • Page 52 Clean the reagent table a Use the supplied blower brush to blow away any debris. b Use a soft cloth to remove any stains. Clean the disposal case If the disposal case is very dirty, wash the disposal case. a Remove the disposal case. b Disinfect the disposal case with 70% isopropyl alcohol and then rinse the case to remove any stains.
  • Page 53 f Place a tip and the container with distilled water into the Container tip port and the cleaning solution port respectively. g Return the tip case to its original position. NOTE: Insert the tip case fully to the back of the instrument.
  • Page 54 ■ Manual Cleaning of Photometric Window (Window Cleaning) Prepare: Cotton swab, distilled water and protective gloves Select a maintenance item a Select “Window cleaning” from the maintenance menu of the operation application and start the process. b The front cover opens and the instrument power turns off. c Remove the tip case and disposal case.
  • Page 55 ■ Cleaning the Nozzle (Nozzle Cleaning) Prepare: Cleaning wire, nozzle tube, protective gloves, and tweezers Move the nozzle to the maintenance position. a Select “Nozzle cleaning” from the maintenance menu of the operation application and start the process. b Remove the maintenance cover in accordance with the messages on the operation application.
  • Page 56 Clean the nozzle a Remove the nozzle tube using the tweezers. b Insert the cleaning wire into the nozzle and move it up and down two or three times to clean the inside of the nozzle. c Use a piece of tissue paper to remove any debris from the tip of the nozzle.
  • Page 57 Attach the nozzle maintenance holder to the instrument a Attach the nozzle maintenance holder. NOTE: Securely attach the nozzle maintenance holder. b Attach the maintenance cover. ■ Replacing the Nozzle (Nozzle Replacing) Prepare:Nozzle, wrench set for replacing nozzle and protective gloves Move the nozzle to the maintenance position.
  • Page 58 Replace the nozzle a Fix the top part of the nozzle using the smaller end of the wrench. NOTE: Be sure to fix the top part of the nozzle with the wrench before removing or attaching the nozzle. Otherwise, the nozzle may be damaged. b Attach the adapter to the bottom of the nozzle.
  • Page 59 d Manually rotate the adapter in the direction of the arrow and remove the nozzle. e Place the new nozzle on the adapter. Attach the adapter to the nozzle maintenance holder and gently tighten by hand. f Use the smaller end of the wrench to fix the top part of the nozzle and use the larger end of the wrench to rotate and further tighten the adapter (at least 90°).

  • Page 60: Manual Cleaning Of The Centrifuge

    ■ Manual cleaning of the centrifuge Do not touch any parts other than those mentioned. Do not use any cleaning or decontamination methods other than those specified. Doing so may damage the instrument. Prepare: Protective gloves, hexagonal wrench, soft cloth and 70% isopropyl alcohol Follow the steps 1 through 3 to manually clean the centrifuge when it is dirty.
  • Page 61 Clean the centrifuge a Wash the centrifuge cover with water and wipe it with cloth. b Clean the inside of the centrifuge (including the centrifuge cup detection sensor) with a cloth moistened with water. NOTE: If the centrifuge cup detection sensor is dirty, a W-3035 or W-3036 warning may occur.

  • Page 62: Quality Control (Qc)

    Quality Control (QC) 3-3-1 QC Tests QC tests are required for quality control. To obtain accurate results in sample measurement, it is necessary to perform QC tests periodically to ensure that the results are within acceptable ranges. 3-3-2 Precautions for Handling Controls For information on how to use controls, please read the package insert supplied with each control.

  • Page 63: Measurement Results (Control Measurement)

    3-3-4 Measurement Results (Control Measurement) When using the optional printer, the measurement result is printed. To check the measurement results on the Application Manual, see the Application Manual. [Print example] Item Description Measurement result Item name and measurement value for which unit conversion and correlation correction are performed QC test result Measurement value for which correlation correction is not performed...

  • Page 64: Reagent Information Setting

    Reagent information setting The available setting parameters are shown in the following table. Item Description See page Single reagent • Sets the correlation correction factor of the parameters for page 3-16 information each instrument. • Sets the normal range for items and patient type. •...
  • Page 65 ■ Printing Result of the Single Reagent Information This section explains how to read the printed result. [Print example] Item Description Measurement date and time Single reagent name The reagent number and single reagent name are printed. Correlation correction The correlation correction factors are printed. factor Normal range The upper and lower limits of normal range are printed.

  • Page 66: Multiple Reagent Information

    3-4-2 Multiple Reagent Information ■ Printing the Multiple Reagent Information For details on printing the multiple reagent information, see the Application Manual. ■ Printing Result of the Multiple Reagent Information This section explains how to read the printed result. [Print example] Item Description Measurement date and...

  • Page 67: Parameter Settings

    Parameter Settings 3-5-1 Unit Information Setting (Unit info setting) The following settings are available on the menu screen of the operation application. For more details, see the Application Manual. ● Unit name ● Status indication LED color ● Speaker volume ●...

  • Page 68: Chapter 4 Troubleshooting

    Troubleshooting Chapter 4 If a warning, error or malfunction occurs during measurement operation or processing with this instrument, a message may be displayed on the screen. This chapter describes the content of these messages and troubleshooting techniques. Message Types A trouble message appears on the display when the instrument has a problem. There are three levels of such messages based on the severity of the problem.

  • Page 69: Warning Messages

    Warning Messages W-001 Printer error Possible aSet the printing paper correctly. solution bSet the printing paper and close the printer cover. cTurn the printer off and on again. W-002 The disposal case is not in place. Possible aPlace the disposal case. solution W-011 The tip case is not in place.
  • Page 70 W-032 Measurement was started with a used reagent strip. Possible aPlace a new reagent strip in the instrument. solution bClean the white/black plates. (See “Daily Cleaning” (page 3-3).) cClean the photometric window. (See “Automatic Cleaning of the Photometric Window (Window Auto Clean)” (page 3-4) or “Manual Cleaning of Photometric Window (Window Cleaning)”...

  • Page 71: Error Messages

    Error Messages E-101 The instrument program version has been changed. Possible aCancel the error in accordance with the instructions on the operation application. solution E-102 Abnormal date/time Possible aSet the correct date/time. (See the Application Manual.) solution E-103 The instrument cannot enter standby for measurement as it is not ready. Possible aTurn the instrument off and on again.
  • Page 72 E-131 The 2D code printed on the reagent strip could not be read. Possible aCheck that the reagent strip is not warped, and place it on the reagent table without solution floating. bPlace a new reagent strip in the instrument. E-141 Abnormal data in the reagent information.

  • Page 73: Trouble Messages

    Trouble Messages T-201 Abnormal internal communication Possible aTurn the instrument off and on again. solution T-202 Clock abnormality Possible aSet the correct date/time. (See the Application Manual.) solution T-203 Memory abnormality Possible aTurn the instrument off and on again. solution T-211 Temperature/humidity sensor abnormality Possible...
  • Page 74 T-224 Reagent table drive abnormality Possible aTurn the instrument off and on again. solution T-231 Unstable light intensity of the light source LED Possible aTurn the instrument off and on again. solution T-232 Unable to set the optical system gain. Possible aClean the white/black plates.

  • Page 75: Chapter 5 Appendix

    Appendix Chapter 5 Patient Type Notation in the Manual ■ Notation Related to Operation Indicates “tapping” an icon or buton. Indicates “selecting” an item. Indicates tapping the input field and “entering” numbers or letters. Setting mark of the instrument to be operated Patient type settings »...
  • Page 76 ■ When changing the patient type name Paitent type name SAVE ■ When changing the correction coefficient For the reagent you want to change, Correciton coefficient A/B/C/D SAVE » SD-4830...
  • Page 77 ■ When importing the correction coefficient IMPORT Patient type SAVE » SD-4830...
  • Page 78 ■ When changing the standard range For the reagent you want to change, Standard range » SAVE SD-4830...

  • Page 79: Computation Items

    Computation Items This system supports the following computation items. The computation items are added to measurement results only when the relevant 2D code is read to set ON, with all values necessary for calculation properly measured. Note that all items are set to OFF by default.

  • Page 80: Simple Mode Measurement Settings

    Simple Mode Measurement Settings When not using the operation application (simple mode measurement) You can set measurement conditions by reading the 2D code before starting measurement. To read the 2D code, use the supplied handheld barcode reader. Operator ID/Sample ID First read the following 2D codes and then read the ID barcode.

  • Page 81: Chapter 6 Index

    Index Chapter 6 Accessories ..........1-6 LAN ............1-9 Adapter ............. 3-10 Lot information ........ 3-16, 3-18 Automatic cleaning of photometric window ..........3-2, 3-4 Maintenance ..........3-2 Maintenance cover ........1-8 Black plate ........... 1-9, 3-3 Manual cleaning of photometric window ..........
  • Page 82 Status indication LED ......... 1-8 Stop button ..........1-9 Parameter settings ........3-19 Survey ............3-19 Part names and functions ......1-8 Survey mode measurement result ..2-15, 2-16 Photometric section cover ....1-10, 3-6 Power button ..........1-9 Power input terminal ........1-9 Precautions for installation .......

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