Arkray SPOTCHEM D-01 Operating Manual
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Arkray SPOTCHEM D-01 Operating Manual

Arkray SPOTCHEM D-01 Operating Manual

Measurement unit for immunity nephelometry
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  • Page 2 Premise Thank you for purchasing our measurement unit for immunity nephelometry, the SPOTCHEM D-01 SD-3810. This manual contains important information on the functions of the SPOTCHEM D-01 SD-3810. This manual is issued by ARKRAY, Inc. Read carefully prior to starting up the unit.
  • Page 3 ©2020 ARKRAY, Inc. • It is strictly prohibited to copy any part of this operating manual without the expressed consent of ARKRAY, Inc. • The information in this operating manual is subject to change without notice. • ARKRAY, Inc. has made every effort to prepare this operating manual as best possible. Should you discover anything strange, incorrect or missing, contact your distributor.
  • Page 4 Symbols The following symbols are used in this operating manual and labels on this instrument to call your attention to specific items. For the meaning of symbols indicated on the labels (including the shipping box) not described below, refer to the leaflet included in the package.
  • Page 5 * There is also a 2D code type operation unit, SPOTCHEM D-00 QR. However, both units are described as “D-00” in this manual.  SPOTCHEM D-01 (measurement unit) Operating Manual (this manual) The SPOTCHEM D-01 is a measurement unit that uses the SPOTCHEM D reagent pack to take various measurement. This operating manual describes the method of measurements and maintenance. D-01...
  • Page 6 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 Inside of the unit Do not touch the inside of the unit or insert foreign bodies into the inside of the unit.
  • Page 7 Photometric sections Do not touch the photometric sections with unprotected hands. During cleaning or maintenance of the reagent table, wear protective gloves to prevent exposure to pathogenic microbes.  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.

  • Page 8: Table Of Contents

    Table of Contents Chapter 1 Before Use ..........1-1 1-1 Overview .
  • Page 9 Chapter 3 Menu Operations ........3-1 3-1 Menu Screen Overview .

  • Page 10: Chapter 1 Before Use

    Chapter 1 Before Use This chapter describes basic information about taking measurements and the operation of the instrument components. Overview ............1-2 1-1-1 Features .

  • Page 11: Overview

    Chapter 1 Before Use Overview 1-1-1 Features  Unit designing The operation unit and measurement units are provided as separate units, thereby enabling you to combine the required measurement units for an optimal system configuration.  Easy measurement operation The equipment automatically performs sample dilution, reagent pipetting and stirring. User’s manual operations are not required and samples are pipetted into the reagent pack to be set to the equipment, thereby yielding stable measurement results.

  • Page 12: Specifications

    1-1 Overview 1-1-2 Specifications SPOTCHEM D-01 (SD-3810) Item Specifications Configuration Instrument, accessories Measurement objects Serum, Plasma, Whole blood (Measurement target depends on reagent. For details, see the package insert of reagent.) Reagent SPOTCHEM D reagent pack Measurement parameter Listed in package insert of reagent...

  • Page 13: Measurement Principle

    Chapter 1 Before Use 1-1-3 Measurement Principle Light from the light source LED passes through the optical filter and becomes monochromatic light with constant wavelengths. There are three wavelengths in total and the optimal wavelength is chosen based on the measurement parameter. The monochromatic light is transmitted to the photometric section of each channel and each measurement cell through the optical fiber.

  • Page 14: Unpacking

    2D code for calibration, protective gloves, and gauze Note that the items not included in the package are underlined in this manual. 1-2-1 Instrument Items included Description Quantity Instrument SPOTCHEM D-01 1-2-2 Accessories Connecting cable Operating manual List of errors/troubles Accessories packing box...
  • Page 15 Chapter 1 Before Use 1-2-3 Accessories Packing Box Nozzle set Wrench set for replacing nozzle Nozzle tube Tip case Item Items included Description Quantity Nozzle set Nozzles with O-rings Wrench set for replacing 2 wrenches, 1 adapter nozzle Nozzle tube Replacement nozzle tube Tip case D-01...

  • Page 16: Part Names And Functions

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

  • Page 17: Rear Side Of Instrument

    Chapter 1 Before Use 1-3-2 Rear Side of Instrument Item Name Function Operation unit connecting Connects the operation unit using a connecting cable. terminal Cooling fan Expels warm air from inside the unit to prevent overheating. Fixing brackets Used to fix this unit to another unit. D-01...

  • Page 18: Measurement Unit Connection And Display

    The on-screen position of the measurement unit connected to the operation unit is determined by the connected terminals. The following shows an example of SPOTCHEM D-01 connected to and SPOTCHEM D-02 connected to the operation unit. The relationship between the connected terminals and the on-screen positions of the measurement...

  • Page 19: Installation

    Chapter 1 Before Use Installation 1-5-1 Precautions for Installation Before installing the instrument, read the following items and always take proper safety precautions. Install the instrument under the supervision of a serviceperson. • Determine a location for the instrument and assemble it in that location. Do not move the instrument with the operation unit or other measurement unit connected.

  • Page 20: Precautions For Moving The Instrument

    1-5 Installation 1-5-2 Precautions for Moving the Instrument When moving the instrument, read the following items and always take proper safety precautions. • Be sure that the operation unit and other measurement units are not connected to the instrument. • Move the instrument with the front cover closed. Moving the instrument with the front cover open may result in exposure to pathogenic microbes or cause damage to the instrument.

  • Page 21: Fixing The Instrument

    Chapter 1 Before Use NOTE: As the fixture can be removed with only screw B being loosed, do not remove screw B completely from the instrument. Bottom cover Screws C Retighten loosed screws B (2 points). Remove screws C (2 points) retaining the bottom cover using the Phillips screwdriver.

  • Page 22: Starting The Instrument

    1-5 Installation 1-5-6 Starting the Instrument Press the button on the operation unit to start the instrument. NOTE: • Before pressing the button, check that maintenance cover is attached. If the maintenance cover is not attached, a W-1001 warning occurs. •...

  • Page 23: Shutting Down The Instrument

    Chapter 1 Before Use Check that the instrument is in standby. The status indication LED changes from white to blue. NOTE: If a warning or error occurs during the startup process, the message “Cannot measure.” may be displayed. This indicates that the instrument cannot perform measurement operations.

  • Page 24: Measurement Precautions

    1-6 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. 1-6-1 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 25: Precautions For Handling Samples

    Chapter 1 Before Use 1-6-2 Precautions for Handling Samples • BE CAREFUL 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 26 Chapter 2 Measurement This chapter describes the methods for measurement and calibration. Before Measurement ..........2-2 2-1-1 Lot calibration .

  • Page 27: Chapter 2 Measurement

    Chapter 2 Measurement 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 Reagent Info.
  • Page 28 2-1 Before Measurement REFERENCE: You can swipe the magnetic stripes in any order. You can start with any stripe. If a stripe has already been read, an asterisk [ * ] is displayed on the screen. After all magnetic stripes of the lot card have been read, magnetic card calibration has been completed.

  • Page 29: Measurement Procedures

    Chapter 2 Measurement 2-1-2 Measurement Procedures The measurement procedures are shown in the following flowchart. Use similar procedures when measuring quality control samples. For details on quality control samples, contact your local distributor. Instrument startup Set the main switch on the operation unit to the ON position and press the button.

  • Page 30: Measurement Preparations

    2-2 Measurement Preparations Measurement Preparations This section explains the preparations required prior to measurement. Please note that the underlined parts are not included in the package. Prepare them separately. 2-2-1 Instrument Checks This explains the items to be checked after the instrument has started. ...

  • Page 31: Measurement

    Chapter 2 Measurement Measurement Measurement is performed using sample and 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 32 2-3 Measurement  Sample ID To add a unique ID to the sample that is separated from the measurement number, enter a sample ID. For details on entering the sample ID, see “4-3 Entering the Sample ID” in the “SPOTCHEM D-00 Operating Manual”.
  • Page 33 Chapter 2 Measurement Place the tips in the tip port. NOTE: Do not touch the end of the tips with unprotected hands. Contamination on the tip end may lead to inaccurate results. Return the tip case to its original position. NOTE: Insert the tip case fully to the back of the instrument.
  • Page 34 2-3 Measurement Start measurement Press the button. The reagent table retracts, and the front cover closes and measurement starts. NOTE: Do not open the maintenance cover or front cover during measurement. If the front cover is opened during measurement, a W-1001 warning occurs.
  • Page 35 Chapter 2 Measurement Remove the discarded tips. NOTE: Take care not to discard the unused tips. Return the tip case to its original position. Dispose of the used reagents. If you do not continue operations, press the button. The reagent table retracts and then the front cover closes. Inspect the photometric sections Clean the photometric sections when measurement for the day is completed.

  • Page 36: Viewing The Measurement Result

    2-4 Viewing the Measurement Result Viewing the Measurement Result You can print out and check the measurement result. 2-4-1 Measurement Result This section explains how to read the printed measurement result. Item Description Unit name Measurement date and time Measurement number Sample type Patient type Printing is available only when the patient type is entered.

  • Page 37: Survey Mode Measurement Result

    Chapter 2 Measurement 2-4-2 Survey Mode Measurement Result This section explains how to read the printed survey mode measurement result. Item Description Unit name Measurement date and time Measurement result Item name and measurement value Survey mode measurement Measurement value for which unit conversion and correlation correction result are not performed D-01...

  • Page 38: Qc Mode Measurement Result

    2-4 Viewing the Measurement Result 2-4-3 QC Mode Measurement Result This section explains how to read the printed QC mode measurement result. Item Description Unit name Measurement date and time QC mode measurement result Item name and measurement value for which unit conversion and correlation correction are not performed D-01 2-13...
  • Page 39 Chapter 2 Measurement D-01 2-14...

  • Page 40: Chapter 3 Menu Operations

    Chapter 3 Menu Operations This chapter describes the sample type setting, maintenance, reagent information setting and various parameter settings on the [Main menu] screen. For details on setting the measurement number, sample ID, measurement result and submenu, see “Chapter 4 Menu Operations” in the “SPOTCHEM D-00 Operating Manual”.

  • Page 41: Menu Screen Overview

    Chapter 3 Menu Operations Menu Screen Overview On the status indication screen, press [0] to display the [Main menu] screen. Press [0]. The [Main menu] screen is displayed. REFERENCE: For details on operating menus [1] to [4], see “Chapter 4 Menu Operations” in the “SPOTCHEM D-00 Operating Manual”.

  • Page 42: Reagent Information Setting

    3-1 Menu Screen Overview  Reagent information setting Item Description See page Item information • Sets the correlation correction factor and patient type for each 3-15 instrument. • After setting correlation correction factors, perform verification measurements to confirm that they are set correctly. •...

  • Page 43: Sample Type Setting

    Chapter 3 Menu Operations Sample Type Setting This section explains how to set the sample type and patient type.  Available settings Item Description Sample type Select the sample type for each CH. When you select the [Default], the sample type which was preset for each reagent is automatically selected.

  • Page 44: Maintenance

    3-3 Maintenance Maintenance 3-3-1 Maintenance Information The date and time of last maintenance and the number of measurements performed since then are displayed. Press [6] on the [Main menu] screen. Press [5] on the [Maintenance] screen. The <Maintenance information> screen is displayed. Date and time of last maintenance Number of measurements...

  • Page 45: Maintenance Items

    Chapter 3 Menu Operations 3-3-2 Maintenance Items 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.

  • Page 46: Cleaning Of The Photometric Sections/Tip Case

    3-3 Maintenance Press [6] on the [Maintenance] screen. The <Maintenance item> screen is displayed.  Cleaning of the photometric sections/tip case Prepare: Blower brush, protective gloves Select a maintenance item Press the [ ] button on the <Maintenance item> screen and select [Opt block clean].
  • Page 47 Chapter 3 Menu Operations Cleaning  Clean the photometric section Use the blower brush supplied with the operation unit to blow away any debris. NOTE: Remove the brush from the blower brush to use it.  Clean the tip case If the tip case is very dirty, wash the tip case.
  • Page 48 3-3 Maintenance Press [3] on the [Submenu] screen. Press [2] on the [Maintenance] screen. Press the button on the <Power On> screen and then move the cursor to the position of this instrument. Press the [ ] button, select [Power on] and press the button.

  • Page 49: Replacing The Tube And Nozzle

    Chapter 3 Menu Operations  Replacing the tube and nozzle Prepare: (at tube replacement): protective gloves, nozzle tube, Phillips screwdriver and tweezers (at nozzle replacement): protective gloves, nozzle, wrench set for replacing nozzle and Phillips screwdriver Move the nozzle to the maintenance position and turn off the instrument Press the [ ] button on the <Maintenance item>...
  • Page 50 3-3 Maintenance Fix the nozzle with the nozzle stopper. Nozzle stopper Press the button. The power turns off. Remove the nozzle maintenance holder from the main body Manually rotate the fixing screw of the nozzle maintenance holder and remove it, as shown in the diagram. Fixing screw ...
  • Page 51 Chapter 3 Menu Operations Replace the nozzle tube Remove the nozzle tube using the tweezers. Attach the new nozzle tube. NOTE: When attaching the nozzle tube, be careful not to insert it too far over the nozzle. 1 mm 1 mm Replace the nozzle Fix the top part of the nozzle using the smaller end of the wrench.
  • Page 52 3-3 Maintenance Attach the adapter to the bottom of the nozzle. Use the larger end of the wrench to rotate the adapter and loosen the nozzle attachment. Manually rotate the adapter in the direction of the arrow and remove the nozzle. D-01 3-13...
  • Page 53 Chapter 3 Menu Operations Place the new nozzle on the adapter. Attach the adapter to the nozzle maintenance holder and gently tighten by hand. 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 54: Reagent Information Setting

    3-4 Reagent Information Setting Reagent Information Setting This section explains how to enter the reagent item information and reagent pack information. The available setting parameters are shown in the following table. Item Description See page Item information • Sets the correlation correction factor of the parameters and patient 3-15 type for each instrument.
  • Page 55 Chapter 3 Menu Operations Press [5] on the [Item info] screen. Set the item information Press the [ ] button on the <Item info setting> screen and select the item to be set. REFERENCE: To print the set value of the item, select the item and press button.

  • Page 56: Printing Result Of The Item Information

    3-4 Reagent Information Setting  Printing result of the item information This section explains how to read the printed result. Item Description Unit name Printed date and time Item name The item number and item name are printed. Correlation correction factor The correlation correction factors are printed.

  • Page 57: Initialization Of The Item Information

    Chapter 3 Menu Operations  Initialization of the item information Press [7] on the [Main menu] screen. Press [5] on the [Reagent info setting] screen. Press [6] on the [Item info] screen. Press the [ ] button on the <Item info initialize> screen and select the item to be initialized.

  • Page 58: Reagent Pack Information

    3-4 Reagent Information Setting Press the button. A message appears prompting you to confirm or cancel initialization of the information. REFERENCE: • To start initialization, press [0]. • To cancel initialization, press the button. 3-4-2 Reagent Pack Information  Printing the reagent pack information Press [7] on the [Main menu] screen.

  • Page 59: Printing Result Of The Reagent Pack Information

    Chapter 3 Menu Operations Press the [ ] button on the <Pack info setting> screen and select the reagent pack to be printed. Press the button. To print all reagent pack information, select [ALL] and press the button.  Printing result of the reagent pack information This section explains how to read the printed result.

  • Page 60: Parameter Settings

    3-5 Parameter Settings Parameter Settings 3-5-1 Unit Information Setting (Unit info setting) You can set the unit name displayed on the screen, the speaker volume and the warning sound pattern. The available settings are shown in the following table. Item Description Unit name You can specify the unit name displayed on the screen with a maximum of seven...
  • Page 61 Chapter 3 Menu Operations  Setting the unit information Press [5] on the [Unit info setting] screen. Set the unit information. The selected pattern of warning sound at the selected volume is emitted for approximately 3 seconds. REFERENCE: Enter characters in the [Unit name] field. For details on entering characters, see “2-3-3 Entering Characters”...

  • Page 62: Mode Setting

    3-5 Parameter Settings 3-5-2 Mode Setting Select the measurement result printing mode. The available settings are shown in the following table. Item Description Normal Prints the normal measurement values. Survey Adds and prints the survey measurement values for which unit conversion and correlation correction are not performed.
  • Page 63 Chapter 3 Menu Operations D-01 3-24...
  • Page 64 Chapter 4 Troubleshooting 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 ..........4-2 4-1-1 Message Types and Display .

  • Page 65: Chapter 4 Troubleshooting

    Chapter 4 Troubleshooting Message Types 4-1-1 Message Types and Display 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. Message type Description Warning Displayed as “W-10XX”.

  • Page 66: Warning Messages

    4-2 Warning Messages Warning Messages W-1001 Cause Possible solution The front cover or maintenance cover was Check the covers if they are completely closed. opened during measurement or startup process. Something is trapped by the front cover. Remove the object and close the front cover. W-1002 Cause Possible solution...
  • Page 67 Chapter 4 Troubleshooting W-1004 Cause Possible solution The tip case is not fully in place. Check that the tip case is correctly placed in the instrument. The tip case is dirty. Clean the tip case. For details, see “Cleaning of the photometric sections/tip case” (page 3-7).
  • Page 68 4-2 Warning Messages W-1007 REFERENCE: The CH number (in which the reagent is placed) and the reagent name are displayed on the first line of the message. Cause Possible solution Fill an appropriate volume of sample (50 μL) in the sample well of The sample reagent has bubbles or foreign bodies.
  • Page 69 Chapter 4 Troubleshooting W-1010 Cause Possible solution There are not enough tips for measurement. Place the number of tips required for measurement in the instrument. W-1011 REFERENCE: The name and lot number for the expired reagent is displayed on the first line of the message. Cause Possible solution The expired reagent is used.
  • Page 70 4-2 Warning Messages W-1013 REFERENCE: The CH number (in which the reagent is placed) and the reagent name are displayed on the first line of the message. REFERENCE: When the calculation of the measurement result gives too high or too low value indicating that the sample type setting could be wrong, a message to the left appears (for example, hemoglobin level is too low for the set sample type “whole blood”).

  • Page 71: Error Messages

    Chapter 4 Troubleshooting Error Messages E-1101 Cause Possible solution The instrument turned off during measurement. Press the button. Prepare the sample, reagent and tip and measure again. NOTE: If the instrument turns off for some reason during measurement, this message is displayed during the next startup process.
  • Page 72 4-3 Error Messages E-1105 Cause Possible solution The required measurement parameter Please contact your local distributor. information has not been entered. REFERENCE: The CH number (in which the reagent is set) and the reagent or the item number without measurement information are displayed.

  • Page 73: Trouble Messages

    Chapter 4 Troubleshooting Trouble Messages T-1201 Cause Possible solution A supply voltage is abnormal. Check that the connecting cable is securely connected. T-1202 / T-1203 Cause Possible solution A malfunction occurred with the internal Check the installation/operating environment and use the instrument temperature control.

  • Page 74: Index

    Chapter 5 Index Index ............5-2 D-01...
  • Page 75 Chapter 5 Index Index ............1-5 ....1-8, 1-12 Accessories Operation unit connecting terminal .......1-5, 1-6 ..............3-6 Accessories packing box O-ring ............. 3-13 Adapter ........3-3, 3-21 Parameter settings ........1-7 ........1-7 CH1 Photometric section Part names and functions ........1-7 ..........
  • Page 76 5-1 Index ........3-21 Unit information setting ............3-21 Unit name ............1-5 Unpacking ..........4-3 Warning messages ........3-21 Warning sound pattern D-01...

This manual is also suitable for:

Sd-3810

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