Arkray ADAMS A1C HA-8180V Operating Manual
Arkray ADAMS A1C HA-8180V Operating Manual

Arkray ADAMS A1C HA-8180V Operating Manual

Automatic glycohemoglobin analyzer
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Summary of Contents for Arkray ADAMS A1C HA-8180V

  • Page 2: Premise

    It is recommended to retain this operating manual for future use. Intended Purpose The ADAMS A1c HA-8180V instrument is intended for the quantitative and automated measurement of HbA1c in whole blood and hemolysis samples. HbA1c measurements are used for screening, monitoring and as an aid to diagnosis of diabetes and prediabetes, for individuals diagnosed with or at risk of developing diabetes or prediabetes.
  • Page 3: Introduction

    ©2010 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.
  • Page 4: Symbols

    Symbols The following symbols are used in this 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 5: Caution Labels

    Caution Labels This instrument has several caution labels on the areas that have potential dangers. Please learn the potential dangers shown by each label and observe the precautions described below. Front a Standby switch This switch turns the power on/off. A separate main power switch is located on the instrument’s rear panel.
  • Page 6 Rear a Power input terminal The power cord (supplied) is plugged in here. Use of other cords may cause electric shock or fire. The fuse holders are also located here. Prepare fuses of the specified capacity for replacement. b Drain joints (D1: For the optical unit, D2: For liquid waste) Liquid waste is drained through these joints into the bottle for liquid waste.
  • Page 7 Front (inside) Temperature control box a Temperature control box Do not touch the tubes and connections with unprotected hands. Wear protective gloves to prevent exposure to pathogenic microbes while cleaning or replacing these parts. b Dilution container and washing container Do not touch the dilution container and washing container with unprotected hands.
  • Page 8: Table Of Contents

    Table of Contents 1 Premise ......................i 2 Introduction .....................ii 3 Symbols ......................iii 4 Caution Labels ....................iv 5 Table of Contents..................vii Chapter 1 Before Use..............1-1 1.1 Overview ..................... 1-2 1.1.1 Main Functions..................1-2 1.1.2 Features....................1-3 1.1.3 Specifications..................1-5 1.1.4 Measurement Principle ................
  • Page 9 1.7.1 Components on the Operator Panel ..........1-41 1.7.2 Basic Operations................1-42 Chapter 2 Measurement............. 2-1 2.1 Before Measurement ................. 2-2 2.1.1 Measurement Procedure ..............2-2 2.1.2 Sample Containers ................2-3 2.1.3 Sample Racks..................2-4 2.2 Measurement Precautions ..............2-7 2.2.1 Precautions for Operation ..............
  • Page 10 3.1 Main Menu Screen ................3-2 3.2 Measurement Counter Setup ............3-6 3.3 Measurement Conditions ..............3-7 3.3.1 Setting the User-specified Coefficients ..........3-7 3.3.2 Setting the Timer Conditions..............3-8 3.3.3 Setting the Timer.................. 3-9 3.3.4 Configuring the Measurement Numbering Method ......3-11 3.3.5 Setting the HbA1 Measurement Conditions ........
  • Page 11 4.2.5 Replacing the Piercing Nozzle/Cleaning the Nozzle Washing Block . 4-15 4.2.6 Replacing the Mesh Filters of the Reagent Nozzles ......4-21 4.2.7 Replacing the Tubes of the Drain Pinch Valves......... 4-24 4.3 Washing and Cleaning ..............4-26 4.3.1 Discarding Liquid Waste ..............4-26 4.3.2 Automatically Washing the Tubes............
  • Page 12 6.1.4 Analysis Section Check Measurement Results ........6-6 6.1.5 HbA1 Reproducibility Test Results............. 6-7 6.1.6 Reagent Information Report..............6-8 6.2 Glossary....................6-9 6.3 Performance Characteristics ............6-12 6.3.1 Analytical Performance ..............6-12 6.3.2 Clinical Performance................6-13 6.4 Index....................6-14 HA-8180V...
  • Page 13 HA-8180V...
  • Page 14 Before Use Chapter 1 This chapter describes information you should know before using the instrument. Overview ......................1-2 1.1.1 Main Functions ....................1-2 1.1.2 Features ......................1-3 1.1.3 Specifications ....................1-5 1.1.4 Measurement Principle..................1-6 Unpacking...................... 1-7 1.2.1 Instrument ......................1-7 1.2.2 Sampler ......................1-8 1.2.3 Accessories .......................1-8 1.2.4 Rack Set ......................1-9...
  • Page 15: Chapter 1 Before Use

    Chapter 1 Before Use Overview 1.1.1 Main Functions The HA-8180V measures HbA1 glycated hemoglobin and provides information necessary for controlling blood glucose in diabetics. It can measure stable HbA1 (S-A1 , HbA1 ) and HbF. Measurements made with the HA-8180V are accurate because labile HbA1 (L-A1 ), carbamylated Hb and acetylated Hb are eluted separately from stable...
  • Page 16: Features

    Overview 1.1.2 Features  90 seconds per sample measurement in the Variant mode, and 48 seconds in the Fast mode. It takes 90 seconds to measure HbA1 and HbF and detect HbS and HbC (Variant mode). Tests for just HbA1 HbF are completed in 48 seconds (Fast mode).
  • Page 17 Startup times can be set for each day of the week. Sleep mode automatically activates if the standby screen appears for a user-set amount of time.  Wide array of options available ARKRAY makes available a wide array of options including the hand-held barcode reader and the side sampler. HA-8180V...
  • Page 18: Specifications

    400 μL or more Sample tube: (12.3/15 mm diameter) × (75 to 100 mm length) Sample container 500 μL Sample cup: Compatible rack type ARKRAY racks Number of measurement One-way transportation (factory-set): Maximum 50 samples samples Loop transportation: Maximum 100 samples Column temperature Approximately 40°C...
  • Page 19: Measurement Principle

    Chapter 1 Before Use Altitude Up to 2000 m Pollution degree Over voltage category Expected life 5 years (According to company data) *3 *1: Error-free measurement ranges *2: Guaranteed ranges for obtaining results equivalent to those from HA-8160 VP mode measurement *3: The manufacturing date is included in the serial number as shown below.
  • Page 20: Unpacking

    Unpacking Unpacking The system comes in three boxes. Unpack the boxes and make sure you have all items listed in this section. If anything is missing or damaged, contact your distributor. NOTE: The following items are not included with the instrument: ELUENT 80A, ELUENT 80B, ELUENT 80CV, HEMOLYSIS WASHING SOLUTION 80H, COLUMN UNIT 80, CONTROL DILUTION SET 80, CALIBRATOR 80, controls for HbA1c measurement, dummy sample, sample cup, sample tube, sample, diluent, sample container, barcode label, protective gloves, tissue paper, piercing...
  • Page 21: Sampler

    Chapter 1 Before Use 1.2.2 Sampler a Sampler Item Description Qty. Sampler With sample tube spinning unit 1.2.3 Accessories a Power cord b Printer paper c Rack set d Accessory case e Tool kit f Operating Manual Item Description Qty. Power cord Rating: 250V 10A Printer paper...
  • Page 22: Rack Set

    Unpacking 1.2.4 Rack Set Sample rack types can be identified by the label color and name on the front of the rack. For more information, see “2.1.3. Sample Racks” on page 2-4. a Normal rack b Start rack No label Light blue, START c Whole blood pair rack d Hemolysis pair rack...
  • Page 23: Accessory Case

    Chapter 1 Before Use 1.2.5 Accessory Case a Optical unit drain tube b Liquid waste drain tube c Tube guide d Conventional adapter e Protective tube f Fuses g O-rings h Joints 1x2 i Joints 2x3 j Cover plate k Spare tube l Spare tube (for column IN) (for column OUT)
  • Page 24: Tool Kit

    Unpacking Item Description Qty. For eluent nozzles, M6 flat seal fitting φ2, push screws and ferrules, Joints 1×2 3 per pack Joints 2×3 For hemolysis washing solution nozzle, M6 flat seal fitting φ3, push screws and ferrules, 2 per pack Cover plate O-ring presser plate for piercing nozzle Spare tube (for column IN)
  • Page 25: Part Names And Functions

    Chapter 1 Before Use Part Names and Functions 1.3.1 Front and Right Side Views Drive units are housed inside the instrument. Power is shut off automatically if the front cover, maintenance cover or side cover is opened during instrument operation. Do not open these covers unless necessary.
  • Page 26 Part Names and Functions Component Description Eluent A pack Contains ELUENT 80A. Eluent B pack Contains ELUENT 80B. Eluent CV pack Contains ELUENT 80CV. Hemolysis washing Contains HEMOLYSIS WASHING SOLUTION 80H. solution bottle Maintenance cover Protects the dilution container unit. Measurements cannot be made if this cover is open.
  • Page 27 Chapter 1 Before Use Inside view Temperature control box Component Description Internal barcode reader The barcode reader unit is connected here. Dilution container unit Dilutes sample in the dilution container and washes the piercing nozzle in the (dilution and washing washing container.
  • Page 28: Rear View

    Part Names and Functions 1.3.2 Rear View e f g Component Description D1 (drain joint) Connects to the optical unit drain tube. D2 (drain joint) Connects to the liquid waste drain tube. Hemolysis washing Carries hemolysis washing solution to the instrument. solution tube (W) Cooling fan (×...
  • Page 29: Installation

    Chapter 1 Before Use Installation 1.4.1 Precautions in Instrument Installation Before installation of the instrument, read the following notes and always take proper safety precautions. Install the instrument under the supervision of a service person. It is dangerous to handle the instrument with the covers open.
  • Page 30: Unlocking The Instrument

    Installation  Use the specified RS-232C cross cable (double-shielded cable) to connect an external device to the 9-pin data output terminal of the instrument. Use of other cables may cause electric shock or fire. For more information, contact your distributor. ...
  • Page 31 Chapter 1 Before Use Unlock the nozzle drive unit. a Open the front cover. b Open the maintenance cover. c Loosen the knurled screw by hand. d Slide the fixing bracket to the right as viewed from the front of the instrument and pull it to the front.
  • Page 32: Attaching The Sampler

    Installation 1.4.3 Attaching the Sampler Prepare: Sampler, Phillips screwdriver, stubby screwdriver (No.6200-1) and double open end wrench (10-13) Remove the wiring box cover. a Loosen the two screws on the left side panel of the main body using the stubby screwdriver and remove the wiring box cover. Connect the sampler cables to the main body.
  • Page 33 Chapter 1 Before Use Attach the sampler. a Fit the hooks on both sides of the sampler into the holes on the main body. Hole • Be careful not to pinch the cables. Hook b Loosen the locking nuts on the legs of the main body with the wrench.
  • Page 34 Installation b Turn the auxiliary leg screws clockwise with the Phillips screwdriver until the auxiliary legs touch the countertop. Countertop NOTE: Excessively turning the auxiliary legs will cause the sampler to rise. Stop turning the auxiliary legs when they touch the Auxiliary legs countertop.
  • Page 35: Checking The Tubes Of The Drain Pinch Valves

    Chapter 1 Before Use 1.4.4 Checking the Tubes of the Drain Pinch Valves Open the side cover. a Open the side cover. Check the tubes. a Check that the four tubes are pinched in the rear hooks. NOTE: There are two hooks on each valve. Always check that the tube is pinched in the REAR hook with an arrow mark.
  • Page 36: Setting Up Eluents And Hemolysis Washing Solution

    Installation 1.4.5 Setting Up Eluents and Hemolysis Washing Solution Be careful to avoid contact between skin, eyes or mouth and eluent or hemolysis washing solution. If any of these reagents make contact with eyes or mouth, immediately wash with plenty of water and consult a doctor. If it makes contact with skin, wash with plenty of water. IMPORTANT: If eluent and hemolysis washing solution are stored in a refrigerator, allow them to adjust to the same environment as the instrument for at least one hour before using them with the instrument.
  • Page 37 Chapter 1 Before Use Attach the pack supporters. a Attach the four pack supporters to the instrument. Pack supporter • Hook the pack supporters on the holes in the center cover. Center cover Fit the eluent tubes into the tube guide. a Fit the tubes from the bottle caps A , B and CV into the grooves in the tube guide.
  • Page 38 Installation b Insert the nozzle of the bottle cap A into the eluent A pack. Tighten the cap securely. NOTE: Attach the bottle caps with nozzle to the packs and bottle somewhere other than above the instrument. Liquid may spill and damage the instrument. c Install the eluent B pack.
  • Page 39: Connecting The Drain Tubes

    Chapter 1 Before Use 1.4.6 Connecting the Drain Tubes Connect the instrument to your lab drainage system or bottle for liquid waste. This instrument has two drains: one for the optical unit and the other for liquid waste.  Do not bend or pinch the optical unit drain tube or liquid waste drain tube. Also, keep objects off of the tubes.
  • Page 40 Installation For the bottle for liquid waste (other than the optional product) or lab drainage system Insert the tubes into the bottle for liquid waste or lab drainage system. Make sure tubes are long enough when cutting, to prevent them from being pulled from the bottle or drainage system.
  • Page 41: Connecting Peripheral Devices

    Chapter 1 Before Use 1.4.7 Connecting Peripheral Devices  Connecting the hand-held barcode reader Connect the optional hand-held barcode reader to the B.C.R terminal on the rear panel of the instrument.  Connecting an external device This instrument has an RS-232C data output terminal for connecting to an external device. Use the specified cable to connect an external device to the instrument.
  • Page 42: Connecting The Power Cord

    Installation 1.4.8 Connecting the Power Cord Use the power cord that comes with the instrument for the electrical connection to avoid electric shock and fire. Prepare: Power cord a Ensure the main power switch is in the off position. • The main power switch should be pressed to the (off) side.
  • Page 43: Starting Up

    Chapter 1 Before Use Starting Up 1.5.1 Turning On the Power for the First Time It will take at most 30 minutes for the instrument to complete warm-up and priming. Turn on the main power switch. a Press the “ – ” side of the main power switch. Turn on the standby switch.
  • Page 44: Installing The Column

    Starting Up 1.5.2 Installing the Column Prepare: COLUMN UNIT 80 and tissue paper Perform priming. a On the standby screen, press Priming Priming menu • The [Priming menu] screen will appear. (0000) 10-06-2010 10:00 Automatic b Select <1 Automatic>. Pump •...
  • Page 45 Chapter 1 Before Use Open the temperature control box cover. a Open the front cover. • The mechanical sections will power off. REFERENCE: The message “W:062 Front or maintenance cover is open.” appears if the front cover is opened before performing step 2. Be sure to perform step 2 first.
  • Page 46: Setting Up The Instrument

    Starting Up 1.5.3 Setting Up the Instrument Check the following before starting measurement: a Printer paper: See “4.2.3. Replacing the Printer Paper” on page 4-10. b Date and time: See “3.5.1. Setting the Date and Time” on page 3-22. c Measurement mode: See “2.4. Measurement Mode Selection (Variant or Fast)” on page 2-14. d Reagent information: See “3.8.
  • Page 47: Turning Off The Power

    Chapter 1 Before Use 1.5.4 Turning Off the Power Follow the instructions described below to turn off the power to the instrument in daily use. REFERENCE: The instrument can be set so that it automatically enters sleep mode after measurements or tube washing. See “3.3.3.
  • Page 48: Relocation

    Relocation Relocation This section describes how to move the instrument to another location. NOTE: The main body and sampler must be boxed for shipping to other locations. For more information, contact your distributor. 1.6.1 Precautions in Instrument Relocation Before relocating the instrument, read the following notes and always take proper safety precautions. ...
  • Page 49: Draining Fluid From The Tubes

    Chapter 1 Before Use 1.6.2 Draining Fluid from the Tubes Remove the eluent packs and hemolysis washing solution bottle from the instrument and drain any remaining fluid from the tubes. Prepare: Cap for hemolysis washing solution bottle (that was originally on the bottle before opening, × 1), caps for eluent packs (that were originally on the packs before opening, ×...
  • Page 50: Unplugging The Power Cord

    Relocation Drain fluid from the tubes. NOTE: Be sure to drain fluid first from the eluent A, B and CV tubes. Eluents cannot be drained if the hemolysis washing solution is drained first. a On the standby screen, select , <7 Maintenance menu>, <5 Drain menu> and <1 Eluent A> in that order. Menu •...
  • Page 51: Disconnecting The Tubes, Sensor Cord And Cables

    Chapter 1 Before Use 1.6.4 Disconnecting the Tubes, Sensor Cord and Cables Remove the bottle for liquid waste, hand-held barcode reader and external device from the instrument.  Wear protective gloves to prevent exposure to pathogenic microbes.  Discard used protective gloves and liquid waste in accordance with local regulations for biohazardous waste.
  • Page 52: Detaching The Sampler

    Relocation 1.6.5 Detaching the Sampler Prepare: Phillips screwdriver and stubby screwdriver (No.6200-1) Detach the sampler. a Lift the sampler straight upward slowly with both hands and pull to the front. • This unhooks the sampler in both locations. b Loosen the two screws on the left side panel of the main body using the stubby screwdriver, and remove the wiring box cover.
  • Page 53: Relocating The Instrument

    Chapter 1 Before Use 1.6.6 Relocating the Instrument Make sure that the front, maintenance and side covers are closed before relocating the instrument. Moving the instrument with any of the covers open may result in exposure to pathogenic microbes and/or damage the instrument. IMPORTANT: For safety reasons, always move the instrument with the help of at least one other person.
  • Page 54: Basic Operations

    Basic Operations Basic Operations This section describes basic instructions to perform measurement and make parameter settings. 1.7.1 Components on the Operator Panel Ready for measurement 10-06-2010 10:00 Measurement start number 0001 Measurement : Variant Column 0000 ABCH Menu Meas No. Priming Icon Name Description...
  • Page 55: Basic Operations

    Chapter 1 Before Use 1.7.2 Basic Operations Standby screen The standby screen appears after the power is turned on, and warm-up and priming are complete. Start all operations for measurement, setup and maintenance from the standby screen and return to this screen after completing the tasks. Ready for measurement Ready for measurement indication 10-06-2010 10:00...
  • Page 56 Basic Operations Setup screens The setup screens are for changing settings, and entering numbers and letters. View (4400) 10-06-2010 10:00 Screen number Date (DD-MM-YY) Setup item <10-06-10> - <10-06-10> Measurement Option: Press the hyphen button [Normal & STAT measurements Results to change options.
  • Page 57 Chapter 1 Before Use  Entering dates Hyphen button: Moves the cursor through the date in the order Start date End date of “day”, “month” and “year”. <15-04-10> - <07-11-10> button: Moves the cursor to the next setup field.  Entering the time Hyphen button: Moves the cursor through the time in the order of “hour”...
  • Page 58: Chapter 2 Measurement

    Measurement Chapter 2 This chapter describes how to perform normal measurement, STAT measurement, HbA1 control measurement and HbA1 calibration. Examples of printed reports showing measurement results and other information are provided at the end of this chapter. Before Measurement ..................2-2 2.1.1 Measurement Procedure ...................2-2 2.1.2...
  • Page 59: Before Measurement

    Chapter 2 Measurement Before Measurement 2.1.1 Measurement Procedure Check before measurement Liquid waste Eluents Hemolysis washing solution Printer paper Power on Press standby switch to power on. • Warm-up and priming Standby screen Ready for measurement 10-06-2010 10:00 Measurement start number 0001 Check the measurement mode Measurement :...
  • Page 60: Sample Containers

    Before Measurement 2.1.2 Sample Containers The following are the sample containers that can be used with this instrument, and the adapters required to set these sample containers in the sample racks. Sample tube Sample tube Sample cup 500 μL Outer Outer diameter diameter...
  • Page 61: Sample Racks

    Chapter 2 Measurement 2.1.3 Sample Racks There are eight types of sample racks in all. These racks can be identified by the label color and name on the front of the rack. Ports No label Orange label marked “H CTRL” Normal rack Hemolysis control rack IMPORTANT:...
  • Page 62 Before Measurement Whole blood pair rack [White, W PAIR] Normal measurement. Use this rack to measure whole blood sample in sample cups. IDs are read from the barcode labels attached to sample tubes. Object Whole blood sample Adapter Odd-numbered ports: Spinning unit adapter (transparent) Even-numbered ports: Conventional adapter (gray) Sample container Odd-numbered ports: Sample tubes (for barcode labels)
  • Page 63 Chapter 2 Measurement Hemolysis control rack [Orange, H CTRL] HbA1 control measurement, HbA1 reproducibility test (hemolysis sample) Object Controls for HbA1 measurement Adapter Odd-numbered ports: Spinning unit adapter (transparent) Even-numbered ports: Conventional adapter (orange) Sample container Sample tubes with controls Odd-numbered ports: Sample tube (control) Even-numbered ports: Empty Sample cups with controls...
  • Page 64: Measurement Precautions

    Measurement Precautions Measurement Precautions 2.2.1 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. Thoroughly read this operating manual before use. ...
  • Page 65: Eluents

    IMPORTANT:  Use only eluents specified for the instrument. ARKRAY provides “ELUENT 80A”, “ELUENT 80B” and “ELUENT 80CV” as eluents specifically for the HA-8180V, Before use, read the package insert that comes with each eluent and observe all handling instructions.
  • Page 66: Hemolysis Washing Solution

    IMPORTANT:  Use only hemolysis washing solution specified for the instrument. ARKRAY provides “HEMOLYSIS WASHING SOLUTION 80H” as hemolysis washing solution specifically for the HA-8180V. Before use, read the package insert that comes with the solution and observe all handling instructions.
  • Page 67: Column

    IMPORTANT:  Use only columns specified for the instrument. ARKRAY provides “COLUMN UNIT 80” as columns specifically for the HA-8180V. Before use, read the package insert that comes with the column and observe all handling instructions.  When storing the columns: •...
  • Page 68: Samples

    Measurement Precautions 2.2.5 Samples  TAKE THE UTMOST CARE WHEN HANDLING BLOOD. This instrument 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 69: Preparation For Measurement

    Chapter 2 Measurement Preparation for Measurement 2.3.1 Checking Liquid Waste and Consumables Check liquid waste. a When using an optional liquid waste bottle, discard liquid waste if it is remaining in the bottle. When using the drainage system at your laboratory, check that the drain tubes are connected properly. Discard liquid waste in accordance with local regulations for biohazardous waste.
  • Page 70 Preparation for Measurement “Initializing ...” • The parameter settings will be read and the mechanical sections will be initialized. “Warming up ...” • The instrument is adjusting internal temperature to enable measurement. • Measurements can be reserved. • The main menu lists only the options available during warm- “Removing air ...”...
  • Page 71: Measurement Mode Selection (Variant Or Fast)

    Chapter 2 Measurement Measurement Mode Selection (Variant or Fast) On the standby screen, check that the instrument is in the Ready for measurement 10-06-2010 10:00 measurement mode you want. If you want to change the measurement mode, see “ To change the mode (Variant or Fast):” below. Measurement start number 0001 Measurement :...
  • Page 72 Measurement Mode Selection (Variant or Fast) d Press • This saves your entries and will return you to the [Measurement condition menu] screen. e To return to the standby screen, press twice. Go back f On the standby screen, check that the mode has been changed. Ready for measurement 10-06-2010 10:00 g Perform control measurement.
  • Page 73: Normal Measurement

    Chapter 2 Measurement Normal Measurement In normal measurement, multiple samples are continuously measured using the sample racks.  Wear protective gloves to prevent exposure to pathogenic microbes.  Discard liquid waste, used samples and protective gloves in accordance with local regulations for biohazardous waste.
  • Page 74 Normal Measurement Items required for normal measurement Prepare sample containers, adapters and sample racks for the samples to measure, in the sequence indicated in the following flow chart. The underlined items are not included with the instrument. Whole blood Sample Hemolysis Anemia, non anemia Anemia (Using anemia rack)*1...
  • Page 75 Chapter 2 Measurement Prepare samples.  For whole blood sample (anemia and non-anemia) a Prepare sample in a sample tube or sample cup. • The volume of sample as shown on the right is required for measurement. b If using a sample tube, make sure the cap is on tight. •...
  • Page 76 Normal Measurement Label the sample tubes with barcode labels (when using the internal barcode reader). Go to step 3 if not using the internal barcode reader. a Label the sample tube with a barcode label. • Attach the barcode label 20 mm or more above the bottom end of the sample tube, as shown on the right.
  • Page 77 Chapter 2 Measurement b Set the sample tubes in the ports of the sample racks. Fit the bottom of the sample tubes into the Sample tube bottom of the rubber cushions so that the tubes stand straight. If the tubes are tilted, they may cause damage to the piercing nozzle.
  • Page 78 Normal Measurement Load the sample racks onto the sampler. NOTE: Load sample racks onto the sampler so that they do not fall over. Spilled sample may damage the instrument. a Fit the recess at the side of the rack into the guide inside the rack loading side.
  • Page 79: Measuring Samples

    Chapter 2 Measurement 2.5.2 Measuring Samples Once samples have been prepared, start measurements. Set the measurement start number (if needed). On the standby screen, check the measurement start number. Set a different number if necessary. If you do not change the number, skip to step 2.
  • Page 80 Normal Measurement b On the standby screen, press Ready for measurement 10-06-2010 10:00 REFERENCE: When the [Confirming HbA1c calibration] screen appears: Measurement start number 0300 See “2.4. Measurement Mode Selection (Variant or Fast)” on page 2-14. Measurement : Variant “Preparing for measurement” Column 0000 •...
  • Page 81: Viewing Measurement Results In Detail

    Chapter 2 Measurement Once measurements are complete for all set samples (end of a batch)  “Waiting for meas. to end” • The tubes will be cleaned after all sample measurements are Waiting for meas. to end 0"48 15.0 kg/cm2 complete.
  • Page 82 Normal Measurement b On the [Main menu] screen, select <4 Results>. Measurement result (Variant mode) • The most recent measurement result will be displayed. Results (4000) 15.0 kg/cm2 c Display the measurement results you want to view. 10-06-2010 10:02 ID 012345678901234567 Meas No.0001 Port No.
  • Page 83: Stat Measurement

    Chapter 2 Measurement STAT Measurement A single sample can be measured by setting it in the STAT port. The STAT port is convenient for interrupting normal measurements to measure an urgent sample or to measure only one sample.  Wear protective gloves to prevent exposure to pathogenic microbes. ...
  • Page 84 STAT Measurement Hemolysis sample IMPORTANT: When using sample tubes to measure hemolysis sample, be sure to prepare the volume of sample as shown on the right. Inaccurate measurement results will be obtained if there is too much sample. Between 10 and 20 mm Sample cup Sample tube...
  • Page 85 Chapter 2 Measurement Set the sample in the STAT port. a Set the adapter in the STAT port if needed. Sample container Required adapter Sample tube (12.3 mm diameter) Conventional adapter (gray, in the accessory case) Sample tube (15 mm diameter) None Sample cup Conventional adapter...
  • Page 86 STAT Measurement When disappears: Measuring ... 0"40 • The beeper will sound and the piercing nozzle will come 15.0 kg/cm2 forward. Sampling in process • The sample in the STAT port will be aspirated and STAT STAT No. 0001 measurement will start. 012345678901234568 •...
  • Page 87: Measuring A Sample During Standby

    Chapter 2 Measurement 2.6.2 Measuring a Sample During Standby With the standby screen on the display, one sample can be measured using the STAT port. Prepare a sample for STAT measurement. a Prepare a sample. • See step 1 in “2.6.1. Measuring a Sample During Normal Measurement” on page 2-26. Set the STAT measurement conditions.
  • Page 88 STAT Measurement Start STAT measurement. a On the standby screen, check the [Measurement mode] setting. • To change the mode, see “2.4. Measurement Mode Selection (Variant or Fast)” on page 2-14. b Press Start REFERENCE: When the [Confirming HbA1c calibration] screen appears: See “2.4.
  • Page 89: Hba1 C Control Measurement

    Chapter 2 Measurement HbA1 Control Measurement 2.7.1 Quality Control Control measurement should be performed at regular intervals to check the status of the instrument and accuracy of measurement results. Use Canterbury HbA1c control (extendSURE Haemoglobin A1c Lyophilised Controls, assignment of standard values is based on JCCRM411) or commercially available controls that are specified by your distributor.
  • Page 90 HbA1 Control Measurement Prepare the control. a Dissolve controls as described in the package insert that comes with the controls. b Dilute the control with DILUENT 80. c Add the diluted control to a sample container. • The volume of control as shown on the right is required for measurement.
  • Page 91 Chapter 2 Measurement  For sample cups with control (when barcodes are set): Odd-numbered ports: Sample tubes with barcode labels [12.3 mm diameter] Use the adapter on the rack. Empty sample tube with barcode label [15 mm diameter] Sample cup with control Remove the adapter.
  • Page 92 HbA1 Control Measurement Set the HbA1 control measurement conditions (when needed). Set the HbA1 control measurement conditions listed below (see “3.3.5. Setting the HbA1 Measurement Conditions” on page 3-13). If already set, skip to step 6. • Control expected values (required to use the control of a different lot) •...
  • Page 93 Chapter 2 Measurement Start control measurement. a On the standby screen, check the [Measurement mode] setting. • To change the mode, see “2.4. Measurement Mode Selection (Variant or Fast)” on page 2-14. IMPORTANT:  Measurement accuracy is controlled separately for the Variant mode and Fast mode. ...
  • Page 94: Hba1 C Calibration

    HbA1 Calibration HbA1 Calibration Calibration provides operation coefficients (calibration coefficients) for correcting measurement results. Use ARKRAY calibrator (CALIBRATOR 80, assignment of standard values is based on JCCRM411).  When calibration is required When required Description After installing the instrument Perform HbA1 calibration before the instrument is used for the first time after installation.
  • Page 95 Chapter 2 Measurement REFERENCE:  About dummy samples: Dummy samples are measured before standard solutions to obtain stable measurement results.  To perform calibration following normal measurements: 1) If necessary, first set the <STD. solution measurement count> and <Calibration error range> (see “3.3.5. Setting the HbA1 Measurement Conditions”...
  • Page 96 HbA1 Calibration Prepare the standard solutions. a Dissolve and dilute the Low and High solutions included in the calibrator. b Add Low and High solution to separate sample cups. • Each sample cup requires a minimum of 400 μL of solution. Low solution High solution Min.
  • Page 97 Chapter 2 Measurement a Load the calibration rack onto the sampler. • See step 4 in “2.5.1. Preparing Samples” on page 2-21. REFERENCE:  If sample rack transportation is set to “loop transportation”: Load the empty start rack and then calibration rack onto the sampler. ...
  • Page 98 HbA1 Calibration Set the calibration information. [For the numeric button operation] a On the standby screen, press b Set the HbA1 calibration conditions. HbA1c calibration • See the table below. 10-06-2010 10:00 • button: Moves the cursor to the next setup field. Standard value (mmol/mol) Hyphen button: Changes the option.
  • Page 99: Setting The Calibration Coefficients

    Chapter 2 Measurement Check the measurement results.  “Measuring ...” Measuring dummy samples • Dummy samples, Low solution and High solution will be measured in that order. Measuring ... 0"40 15.0 kg/cm2 REFERENCE: Sampling in process Dummy 0002 Port No. 0011 About stirring: 012345678901234568...
  • Page 100 HbA1 Calibration c Below <Calibration method>, select <Calibration coefficients HbA1c calibration setting>. 10-06-2010 10:00 • Hyphen button: Changes the option. Standard value (mmol/mol) button: Moves the cursor to the next setup field. L < 0> H < 0> Conversion to NGSP: Y = a X + b a: <0.0915>...
  • Page 101: Displayed And Printed Reports

    Chapter 2 Measurement Displayed and Printed Reports 2.9.1 Displayed Results Report The instrument displays measurement result reports as shown below when results are obtained in normal measurement, STAT measurement, HbA1 control measurement and HbA1 automatic calibration. Press to close the Close result window.
  • Page 102: Chromatogram Report

    Displayed and Printed Reports 2.9.2 Chromatogram Report The instrument automatically prints out a chromatogram report each time it obtains a result in normal/STAT/HbA1 control measurements and HbA1 automatic calibration. The chromatogram report can be reprinted if needed. See “3.4.1. Printing/Transmitting Results” on page 3-15. Example (Variant mode) Measurement date and time Current measurement mode: Var.
  • Page 103: List Of Measurement Results

    Chapter 2 Measurement  HbA1 and HbF measurement results The following indications are included in printouts if inaccurate measurement results were obtained. Indication Description --.- An abnormal measurement result was obtained. “****** Abnormal Fraction ******” will be printed, and then below the chromatogram, a message about the abnormal value will be printed (see “5.4. Abnormal Result Messages”...
  • Page 104: List Of Abnormal Results

    Displayed and Printed Reports 2.9.4 List of Abnormal Results The list of abnormal results contains the measurement numbers and messages of the results for which “Abnormal Fraction” appeared on the measurement result reports. The instrument automatically prints this report at the end of a batch.
  • Page 105: History Of Warning/Error/Trouble

    Chapter 2 Measurement 2.9.6 History of Warning/Error/Trouble The history of warning/error/trouble contains the codes and messages of warnings (W:091 to W:095), errors and trouble that occurred. REFERENCE: For more information about: • Warnings, see “5.1. If a Warning Occurs” on page 5-2. •...
  • Page 106: Calibration Results Report

    Displayed and Printed Reports 2.9.7 Calibration Results Report The instrument automatically prints calibration results report in the following cases: • When calibration results have been obtained after calibration • Before starting measurement of samples This report can be reprinted if needed (see “3.6.4. Printing Calibration Result Report” on page 3-28). Example: Automatic calibration HbA1c calibration result Var.
  • Page 107 Chapter 2 Measurement HA-8180V 2-50...
  • Page 108: Chapter 3 Auxiliary Operations

    Auxiliary Operations Chapter 3 This chapter describes auxiliary operations such as how to print and view measurement results, set measurement conditions, set up the instrument, and perform diagnostic checks. Main Menu Screen ..................3-2 Measurement Counter Setup ............... 3-6 Measurement Conditions ................3-7 3.3.1 Setting the User-specified Coefficients .............3-7 3.3.2...
  • Page 109: Main Menu Screen

    Chapter 3 Auxiliary Operations Main Menu Screen To go to the [Main menu] screen, press on the standby Menu Menu Meas No. Priming screen. On the [Main menu] screen, you can make instrument settings, review measurement results and perform operations Main menu necessary for maintenance tasks.
  • Page 110 Main Menu Screen Option Description (default bolded) Page HbA1c measurement Sets HbA1 control measurement parameters, HbA1 calibration conditions, 3-13 setup (3400) pressure unit for the column and error trigger conditions. Control expected values (mmol/mol) L: 0 to 99 mmol/mol (0 mmol/mol) H: 0 to 200 mmol/mol (0 mmol/mol) Control measurement count: 1 to 3 times (3 times)
  • Page 111 Chapter 3 Auxiliary Operations Option Description (default bolded) Page External output setup Activates or deactivates external output. 3-24 (5300) Use/Not use: Use, Not use Beeper volume Controls the volume of the beeper that alerts you to a warning, error or trouble. 3-24 setting (5400) Beeper volume: 00 to 09 (05)
  • Page 112 Main Menu Screen  [Instrument diagnosis menu] screen (8000) Option Description (default bolded) Page Flow test menu All (8110): 3-29 (8100) Tests the drive unit, sample introduction flow and drain flow once each. Drive unit test (8120): 3-30 Tests the drive unit. Sample introduction flow test (8130): Tests the sample introduction flow.
  • Page 113: Measurement Counter Setup

    Chapter 3 Auxiliary Operations Measurement Counter Setup This section describes how to set the column measurement counter. This counter appears in <Column> on the standby screen. Usually, the counter should be reset to “0000” after the column has been replaced with a new one. If you wrongly reset the counter, follow the instructions described below to set the counter to a desired number.
  • Page 114: Measurement Conditions

    Measurement Conditions Measurement Conditions 3.3.1 Setting the User-specified Coefficients Set coefficients “a” and “b” of the correction formula for HbA1 and HbF, “Y=aX+b”. a On the standby screen, check the [Measurement mode] setting. • To change the mode, see “2.4. Measurement Mode Selection (Variant or Fast)” on page 2-14. IMPORTANT: User-specified coefficients are stored separately for the Variant and Fast modes.
  • Page 115: Setting The Timer Conditions

    Chapter 3 Auxiliary Operations 3.3.2 Setting the Timer Conditions  Startup timer The startup timer starts the instrument up automatically at the set time. Different startup times can be set for each day. The timer can also be set so that the instrument does not start up at all on certain days such as holidays. ...
  • Page 116: Setting The Timer

    Measurement Conditions 3.3.3 Setting the Timer The instrument can be scheduled to enter sleep mode the moment that measurement or tube washing finishes. When using the startup timer, you can select the day to start up the instrument next time. The instrument then turns on automatically at the set time on the day.
  • Page 117 Chapter 3 Auxiliary Operations To cancel the timer setting The standby switch alternately lights green and orange when the timer is set. a Select , and then <9 Set timer>. Menu • The timer setting will be canceled and the standby switch will light green. To start the instrument from sleep mode The standby switch lights orange during sleep mode.
  • Page 118: Configuring The Measurement Numbering Method

    Measurement Conditions 3.3.4 Configuring the Measurement Numbering Method  Measurement start number Set how the measurement start number is determined for the next batch.  Measurement number Set whether to assign measurement numbers to samples or ports. a On the standby screen, select , <3 Measurement condition menu>...
  • Page 119 Chapter 3 Auxiliary Operations IMPORTANT: Note when setting <Measurement number> to <Assign to ports>: • If you manually set the measurement start number to any number other than “0001” (see step 1 in “2.5.2. Measuring Samples” on page 2-22), set samples for the first sample rack only in ports of the same number as the last digit in the measurement start number, or in ports of a higher number than that.
  • Page 120: Setting The Hba1 C Measurement Conditions

    Measurement Conditions 3.3.5 Setting the HbA1 Measurement Conditions Set HbA1 calibration conditions, HbA1 control measurement parameters, pressure unit for the column and error trigger conditions. a On the standby screen, select , <3 Measurement condition menu> and <4 HbA1c measurement setup> in Menu that order.
  • Page 121 Chapter 3 Auxiliary Operations Setup item Description (default bolded) Control expected Set control expected values of the controls you are using. These values are written on the values (mmol/mol) package insert of the controls. L: Low solution 0 to 99 mmol/mol (0 mmol/mol) H: High solution 0 to 200 mmol/mol (0 mmol/mol) Control Set the number of times for measuring the control in a single sample container.
  • Page 122: Measurement Results

    Measurement Results Measurement Results This section describes how to print, transmit, review and delete measurement results stored in the memory of the instrument. REFERENCE:  The instrument stores up to 900 measurement results obtained by the following measurements of both measurement modes in the memory: normal measurement, STAT measurement, control measurement, calibration (dummy sample and standard solution), HbA1 reproducibility test and analysis section check.
  • Page 123 Chapter 3 Auxiliary Operations Setup item Description (default bolded) Date (DD-MM-YY) Set a range of measurement dates. The end (right) date must be the same as or later than the start (left) date. Settable range: 01-01-00 to 31-12-99 Measurement Select the type of measurement from: Normal &...
  • Page 124 Measurement Results f Press • Printing/transmission will start for the selected measurement results. • The [Measurement result menu] screen will appear again when printing is complete. REFERENCE: If “None found.” appears on the display: No match is found in the memory. Press to return to the screen shown in step c.
  • Page 125: Reviewing Results

    Chapter 3 Auxiliary Operations 3.4.2 Reviewing Results Measurement results stored in the memory can be reviewed on the display. You can choose to view all measurement results in order or individual measurement results specified by type or number of the measurement. Peak information and chromatograms for searched results can also be displayed.
  • Page 126 Measurement Results Editing IDs a Display the result whose ID you want to modify. • See “ Reviewing measurement results” on page 3-18. b Press the hyphen button. Or, select , and then <1 Sample info. edit>. Function c Enter a correct ID. View (0200/0200) •...
  • Page 127 Chapter 3 Auxiliary Operations Printing/transmitting results or setting sample information a Display the measurement result you want. • See “ Reviewing measurement results” on page 3-18. b Press Function View (0200/0200) (4400) 10-06-2010 10:00 c Select one of the options listed below. 10-06-2010 10:00 ID 012345678901234567 Meas No.0001 Port No.0001 Variant Function menu...
  • Page 128: Deleting Results

    Measurement Results 3.4.3 Deleting Results Measurement results and history of warning/error/trouble stored in the memory can be deleted. You can delete all data at a time or select specific types of data from normal and STAT measurement results, control measurement results and history of warning/error/trouble.
  • Page 129: Initial Settings

    Chapter 3 Auxiliary Operations Initial Settings 3.5.1 Setting the Date and Time The internal system clock may not keep the right time after initial installation of the instrument or if the instrument has not been used for extended periods of time. Set the system clock correctly, since the date and time of measurements are recorded according to the system clock.
  • Page 130: Setting Up The Printer

    Initial Settings 3.5.2 Setting Up the Printer You can deactivate the printer if you do not wish to print anything. When using the printer, you can select whether or not to: • Include peak information and/or chromatograms in individual measurement result reports, •...
  • Page 131: Setting Up External Output

    Chapter 3 Auxiliary Operations 3.5.3 Setting Up External Output Activate external output of the instrument when an external device is connected to the DATA OUT terminal on the rear panel. External output is deactivated as a default, so the instrument cannot communicate with the external device even when connected to it.
  • Page 132: Print

    Print Print 3.6.1 Printing History of Warning/Error/Trouble You can print out a history of warnings (W:091 to W:095), errors and troubles that occurred in a specified period. They are listed in the order of oldest first regardless of whether they occurred in the Variant or Fast mode. The instrument stores a total of up to 100 occurrences in the memory.
  • Page 133: Printing A List Of Barcode Errors

    Chapter 3 Auxiliary Operations 3.6.2 Printing a List of Barcode Errors You can print out a list of measurement results for which the barcodes were misread on a specific day. REFERENCE: Printed report example: See “2.9.5. List of Barcode Errors” on page 2-47. a On the standby screen, select , <6 Print menu>...
  • Page 134: Printing A List Of Abnormal Results

    Print 3.6.3 Printing a List of Abnormal Results The list of abnormal results contains the measurement numbers and messages of the results for which “Abnormal Fraction” appeared on the chromatogram reports. You may use the lists to determine causes of inaccurate measurement results.
  • Page 135: Printing Calibration Result Report

    Chapter 3 Auxiliary Operations 3.6.4 Printing Calibration Result Report You can print out the most recent calibration result report. This report lists either the coefficients obtained by HbA1 automatic calibration or the manually set coefficients, whichever of the two operations performed last. REFERENCE: Printed report example: See “2.9.7.
  • Page 136: Diagnosis

    Diagnosis Diagnosis 3.7.1 Testing the Whole Flow System You can run a series of tests on the drive units, sample introduction flow and drain flow once each. Use this whole flow system test to check instrument operation after trouble occurs. NOTE: The same tests are performed for both the Variant mode and Fast mode.
  • Page 137: Testing Individual Flow Circuit

    Chapter 3 Auxiliary Operations 3.7.2 Testing Individual Flow Circuit You can test any of the flow circuits listed below independent of the others. Anywhere between 1 and 99 test cycles can be set. These tests consume less eluents and hemolysis washing solution than used in actual measurements. Perform these tests to check instrument operation after trouble occurs.
  • Page 138: Printing Accuracy Control Reports

    Diagnosis 3.7.3 Printing Accuracy Control Reports You can print out statistical information on HbA1 control measurements and sample measurements for a specified period of time. Use this report to check the status of accuracy control. REFERENCE: Printed report example: See “6.1.2. Accuracy Control Reports” on page 6-4. a On the standby screen, select , <8 Instrument diagnosis menu>...
  • Page 139: Printing Optical Unit Monitoring Results

    Chapter 3 Auxiliary Operations 3.7.4 Printing Optical Unit Monitoring Results The optical unit monitoring result report shows the changes in light absorption of the optical unit over the last 10 minutes. NOTE: Monitoring is performed for the same duration of time in both the Variant and Fast modes. REFERENCE: Printed report example: See “6.1.3.
  • Page 140: Performing Check Measurement For The Analysis Section

    Diagnosis 3.7.5 Performing Check Measurement for the Analysis Section Follow the instructions described below to perform a check measurement for the analysis section if measurement results seem inaccurate. This test measures the hemolysis washing solution 5 times in order to check that the analysis section is working properly.
  • Page 141: Testing Hba1 C Reproducibility (Whole Blood Sample)

    Chapter 3 Auxiliary Operations 3.7.6 Testing HbA1 Reproducibility (Whole Blood Sample) Run a reproducibility test following the instructions described below if the reproducibility of HbA1 measurement results seems to have been reduced in anemia or non-anemia whole blood sample measurements. This test repeatedly measures the same whole blood sample and displays statistical information (average, R, S.D.
  • Page 142 Diagnosis d Set the sample tube in port 1 of the specified sample rack. • For sample tubes of a 12.3 mm diameter, set a spinning unit adapter (transparent) in the port before setting the tube. Sample tube with whole blood e Load the sample rack onto the sampler.
  • Page 143: Testing Hba1 Reproducibility (Hemolysis Sample)

    Chapter 3 Auxiliary Operations 3.7.7 Testing HbA1 Reproducibility (Hemolysis Sample) Run a reproducibility test following the instructions described below if the reproducibility of HbA1 measurement results seems to have been reduced in hemolysis sample measurements. This test repeatedly measures the same hemolysis sample or hemolysis control divided into multiple sample containers, and displays statistical information (average, R, S.D.
  • Page 144 Diagnosis For sample cups: Odd-numbered ports: Empty Even-numbered ports: Sample cup Sample cup with Empty sample e Load the hemolysis control rack onto the sampler. Measure the samples. a Press Start Hemolysis sample measurement0"40 • Measurement will start. (8520) 15.0 kg/cm2 •...
  • Page 145: Reagent Information Settings

    Chapter 3 Auxiliary Operations Reagent Information Settings Reagent information includes the lot number, expiration date and manufacturing date of the specific reagent. You can store this information in the instrument for the reagents listed below, and use it to manage your reagents. Eluent A, eluent B, eluent CV, hemolysis washing solution and calibrator Reagent information settings can be made just by entering 10-digit codes supplied with individual reagent products.
  • Page 146 Reagent Information Settings b On the standby screen, select , <2 Reagent replacement Menu Edit reagent information menu> and <6 Edit reagent information>. (2600) 10-06-2010 10:00 • The current information will appear. Code Lot No. Expiry • Hyphens (---) appear where no information has been set. Elu.
  • Page 147: Printing Reagent Information

    Chapter 3 Auxiliary Operations 3.8.3 Printing Reagent Information Reagent information can be printed out as follows: • At the beginning of batches • On individual measurement result reports REFERENCE: Printed report example: See “2.9.7. Calibration Results Report” on page 2-49 and “6.1.6. Reagent Information Report”...
  • Page 148: Chapter 4 Maintenance

    Maintenance Chapter 4 This chapter describes instructions for performing maintenance tasks including replacement of consumables such as reagents and printer paper and cleaning of the piercing nozzle, dilution container and washing container. Frequency of Maintenance................4-2 Replacement of Consumables..............4-3 4.2.1 Replacing the Eluent Packs ................4-3 4.2.2...
  • Page 149: Frequency Of Maintenance

    Chapter 4 Maintenance Frequency of Maintenance This section lists the parts that require maintenance and the standard frequency to perform maintenance tasks. Referring to the table below, clean or replace the parts at recommended intervals.  Wear protective gloves to prevent exposure to pathogenic microbes when performing maintenance tasks marked with a checkmark ().
  • Page 150: Replacement Of Consumables

    Replacement of Consumables Replacement of Consumables 4.2.1 Replacing the Eluent Packs Replace the eluent pack if “W:053 No Eluent A”, “W:054 No Eluent B” or “W:055 No Eluent CV” appears on the display. Be careful to avoid contact between skin, eyes or mouth and eluent. If eluent makes contact with eyes or mouth, immediately wash with plenty of water and consult a doctor.
  • Page 151 Chapter 4 Maintenance a Below <Code>, enter the 10-digit reagent code that is written on Eluent A the label of a new eluent pack. (2100) 10-06-2010 10:00 • If your entry is accepted, the lot number and expiration date will be updated.
  • Page 152 Replacement of Consumables b Wipe any liquid from the nozzle with a new piece of gauze. NOTE: Remove any lint if it is stuck to the nozzle. Lint may clog the tube. c Insert the nozzle of the bottle cap into the new pack and tighten the cap securely.
  • Page 153 Chapter 4 Maintenance Remove air from the eluent by priming. REFERENCE: To replace another reagent: Select the next reagent you want to replace on the [Reagent replacement menu] screen at this point. You can then replace the next reagent without priming the last reagent you replaced. Once all reagents have been replaced, press Go back on the [Reagent replacement menu] screen to start priming for all of the new reagents.
  • Page 154: Replacing The Hemolysis Washing Solution Bottle

    Replacement of Consumables 4.2.2 Replacing the Hemolysis Washing Solution Bottle Replace the hemolysis washing solution bottle if “W:052 No hemolysis washing solution” appears on the display. Be careful to avoid contact between skin, eyes or mouth and hemolysis washing solution. If the solution makes contact with eyes or mouth, immediately wash with plenty of water and consult a doctor.
  • Page 155 Chapter 4 Maintenance Remove the used hemolysis washing solution bottle. a Lay out some gauze near the instrument. b Remove the bottle cap with nozzle from the bottle. • Place the nozzle on the gauze. Place the new hemolysis washing solution bottle. a Remove the cap from a new hemolysis washing solution bottle.
  • Page 156 Replacement of Consumables Reset the remaining reagent graphic for the hemolysis washing solution. a Press Finish • This resets the remaining reagent graphic for hemolysis washing solution. • The <Reagent replacement menu> screen will appear again. NOTE: If an error message appears: The reagent information is invalid.
  • Page 157: Replacing The Printer Paper

    Chapter 4 Maintenance 4.2.3 Replacing the Printer Paper Red lines appear along both edges of the printer paper when the paper is near the end of the roll. Replace the paper roll as soon as possible. An out-of-paper icon appears on the display if the printer runs out of paper. Promptly set a new roll.
  • Page 158: Replacing The Column

    Replacement of Consumables 4.2.4 Replacing the Column Carefully read the package insert that comes with the column for the replacement of the column. If the message “Column should be replaced. Replace column now?” appears on the display, use this as a reference for deciding when to replace the column.
  • Page 159 Chapter 4 Maintenance Detach the old column. The column and column holder may be hot. Before touching the column, place your hand near to the column to make sure that it is not hot. If the column is hot, the temperature controlling unit may break.
  • Page 160 Replacement of Consumables Remove air from the column by priming. a Press and wait about 30 seconds. Pump • Fluid pumping starts, and liquids and bubbles overflow from the connection between the column and push screw. • Priming is complete (in about 30 seconds) when bubbles are no longer formed and only liquid overflows. NOTE: Slightly loosen the push screw if liquid does not overflow from the connection.
  • Page 161 Chapter 4 Maintenance Close the covers. a Close the temperature control box cover, then the front cover. Complete maintenance. a Press Finish Column (2500) 10-06-2010 10:00 REFERENCE: The message “W:062 Front or maintenance cover is open.” appears if Finish is pressed with the front cover open. Be Attach push screw to the bottom sure to close the front cover before pressing Finish...
  • Page 162: Replacing The Piercing Nozzle/Cleaning The Nozzle Washing Block

    Replacement of Consumables 4.2.5 Replacing the Piercing Nozzle/Cleaning the Nozzle Washing Block  Cleaning the nozzle washing block and replacing the O-ring Replace the O-ring of the nozzle washing block every 3000 measurements. Hemolysis washing solution may leak from the nozzle washing block if the O-ring degrades. The piercing nozzle may not be adequately washed as a result. Always clean the bottom of the nozzle washing block when replacing the O-ring.
  • Page 163 Chapter 4 Maintenance Remove the STAT port cover. a Open the front cover. • The mechanical sections will power off. REFERENCE: The message “W:062 Front or maintenance cover is open.” appears if the front cover is opened before performing steps 1-a to 1-c.
  • Page 164 Replacement of Consumables c With the nozzle guide held down to where it stops (a), pull the piercing nozzle upward with the other hand and move it to the front (b). d Remove the nozzle tube from the piercing nozzle. •...
  • Page 165 Chapter 4 Maintenance Replace the O-ring. a Remove the cover plate. • While holding the nozzle washing block still with one hand, gently pull the front tab with the other hand to the front. Front tab b Remove the old O-ring with tweezers AA. c Wipe off dirt from the groove that holds the O-ring.
  • Page 166 Replacement of Consumables c With the nozzle guide held down to where it stops, pass the tip of the piercing nozzle through the two installation holes. • Fit the projection at the top of the piercing nozzle into the recess in the nozzle holder (a).
  • Page 167 Chapter 4 Maintenance Complete maintenance. a Select <Done> for the maintenance tasks you performed. Piercing nozzle maintenance • button: Moves the cursor to the next setup field. (7200) 10-06-2010 10:00 Hyphen button: Changes the option. Piercing nozzle cleaning [Not yet Nozzle washing block maintenance b Press [Done...
  • Page 168: Replacing The Mesh Filters Of The Reagent Nozzles

    Replacement of Consumables 4.2.6 Replacing the Mesh Filters of the Reagent Nozzles Replace the mesh filters of the nozzles for eluents and hemolysis washing solution every 6000 measurements. Trouble may occur with the flow if the mesh filters become clogged. IMPORTANT: Replace the mesh filter for one reagent at a time.
  • Page 169 Chapter 4 Maintenance Replace the mesh filter. a Turn the cap of the filter holder by hand and remove it. Filter holder cap b Remove the old brown O-ring and mesh filter from the holder using tweezers AA. Brown O-ring c Put a new mesh filter in the filter holder.
  • Page 170 Replacement of Consumables Remove air from the tube by priming. a Perform priming for the tube and pump fluid to it. • Eluent nozzle: Perform priming for the applicable eluent, and then pump fluid to the tube. Hemolysis washing solution nozzle: Perform priming for hemolysis washing solution. •...
  • Page 171: Replacing The Tubes Of The Drain Pinch Valves

    Chapter 4 Maintenance 4.2.7 Replacing the Tubes of the Drain Pinch Valves Replace the tubes of the drain pinch valves every 6 months or if the tubes aspirate foreign matter.  Wear protective gloves to prevent exposure to pathogenic microbes. ...
  • Page 172 Replacement of Consumables NOTE:  Connect tubes to the correct joints. Liquid may leak if tubes are connected to the wrong joints or loose. The instrument may be damaged as a result.  Check tubes are not kinked at the joints. If the tubes are kinked, it may cause liquid waste to obstruct the flow.
  • Page 173: Washing And Cleaning

    Chapter 4 Maintenance Washing and Cleaning 4.3.1 Discarding Liquid Waste Discard liquid waste from the bottle for liquid waste before starting the first measurement every day. This instrument drains liquid waste from two drain joints on the rear panel: “D1” for the optical unit and “D2” for liquid waste. During measurements, regularly check the volume of liquid waste in the bottle and discard it before the bottle becomes full.
  • Page 174 Washing and Cleaning Prepare the washing solution for tubes. a Add 7 mL of washing solution for tubes to each of two sample tubes. Washing solution for tubes (7 mL) b Set the sample tubes in ports 1 and 2 of the washing rack. NOTE: Be sure to use the washing rack.
  • Page 175: Automatically Washing The Tubes After Measurement

    Chapter 4 Maintenance 4.3.3 Automatically Washing the Tubes After Measurement You can automatically wash tubes after sample measurement by loading a washing rack after sample racks with samples. Set sample tubes with washing solution for tubes in the washing rack. ...
  • Page 176 Washing and Cleaning Start measurement. a On the standby screen, press Wash tubes. 1"30 • Normal measurements will start. 15.0 kg/cm2 • The message “Wash tubes.” will appear when the washing rack Sampling in process is detected. Meas No. 0300 Port No.
  • Page 177: Cleaning The Piercing Nozzle

    Chapter 4 Maintenance 4.3.4 Cleaning the Piercing Nozzle Clean the piercing nozzle once a week. Contaminated piercing nozzle accelerates degradation of the O-ring of the nozzle washing block. If the O-ring degrades, hemolysis washing solution may leak, resulting in inaccurate measurement results.
  • Page 178 Washing and Cleaning Attach the STAT port cover. Be sure to attach the STAT port cover. This reduces sample splattering if sample tubes are not capped. a Place the STAT port cover in its original position and tighten the knurled screw by hand. b Close the front cover.
  • Page 179: Cleaning The Sample Tube Spinning Unit

    Chapter 4 Maintenance 4.3.5 Cleaning the Sample Tube Spinning Unit Clean the sample tube spinning unit once a month. The sample tube spinning unit cannot spin sample tubes properly if the rollers are contaminated.  Wear protective gloves to prevent exposure to pathogenic microbes. ...
  • Page 180 Washing and Cleaning b Loosen the knurled screw by hand, and pull the STAT port cover to the front to remove it. Knurled screw Clean the sample tube spinning unit. a Wipe off dirt from the parts listed below using gauze moistened with purified water.
  • Page 181: Cleaning The Dilution Container And Washing Container

    Chapter 4 Maintenance 4.3.6 Cleaning the Dilution Container and Washing Container Wash the dilution container unit and its cover once a month. (The unit consists of both the dilution container and washing container.) Inaccurate measurement results may be obtained if the dilution container and washing container are contaminated.
  • Page 182 Washing and Cleaning Remove the dilution container cover. a Open the front cover. • The mechanical sections will power off. REFERENCE: The message “W:062 Front or maintenance cover is open.” appears if the front cover is opened before performing steps 1-a to 1-c.
  • Page 183 Chapter 4 Maintenance Attach the dilution container cover. a Attach the dilution container cover so that the two pins on the left side of the dilution container unit fit into the two holes on the back of the dilution container cover. NOTE: Check that the dilution container cover is level as seen from the front.
  • Page 184: Cleaning The Parts Of The Dilution And Washing Containers

    Washing and Cleaning 4.3.7 Cleaning the Parts of the Dilution and Washing Containers Disassemble the dilution container unit and wash the parts once a year. (The unit consists of both the dilution container and washing container.) Inaccurate measurement results may be obtained if the dilution container and washing container are contaminated.
  • Page 185 Chapter 4 Maintenance Remove the dilution container holder. a Turn the metal dilution container holder on the bottom of the dilution container unit counterclockwise (a) and remove the holder (b). Dilution container holder Remove the stirrer piece and O-ring. a Remove the white stirrer piece from the dilution container holder. b Pinch the black O-ring with tweezers AA and pull it off the Stirrer piece dilution container holder.
  • Page 186 Washing and Cleaning c Attach the dilution container holder to the dilution container unit. • Set the dilution container holder so that the two pipes on it can fit into the wider notch on the bottom of the dilution container unit. Wide notch Pipes •...
  • Page 187: Disinfection

    Chapter 4 Maintenance Complete maintenance. a Close the maintenance cover, then the front cover. • The mechanical sections will power on and initialize. NOTE: Close the cover to initialize the mechanical sections even if you are not going to perform measurements or other operation right away.
  • Page 188: Priming

    Priming Priming Usually, air is automatically removed from the tubes by priming before measurement. Follow the instructions described below when you are instructed to perform priming or fluid pumping after replacing parts, or when remedying warning, error or trouble. Priming can be selected from the seven types listed below. •...
  • Page 189: Recording Maintenance

    Chapter 4 Maintenance Recording Maintenance 4.5.1 Recording the Date of Maintenance After replacing or cleaning parts, the instrument automatically records that date. You can use this information as a reference for the next time maintenance is needed. Maintenance dates can also be manually entered after performing tasks that do not provide automatic recording or when you want to change the recorded dates.
  • Page 190: Viewing Maintenance History

    Recording Maintenance 4.5.2 Viewing Maintenance History You can display the last date of each maintenance task and the number of measurements performed since that date for viewing. a On the standby screen, select , <7 Maintenance menu> Menu Maintenance information (1/5) and <7 Maintenance information>...
  • Page 191: Before/After Extended Periods Of Disuse

    Chapter 4 Maintenance Before/After Extended Periods of Disuse 4.6.1 Preparing the Instrument Before Extended Periods of Disuse When you do not intend to use the instrument for one week or more, follow the instructions described below to clean each part. Failure to do so may cause remaining fluid to crystallize and clog the tubes, resulting in damage to the instrument.
  • Page 192 Before/After Extended Periods of Disuse Store the column. a Detach the column from the column holder and press the tube until it is protruding about 3 mm from the push screws. • See step 3 in “4.2.4. Replacing the Column” on page 4-12. b Seal the both ends of the column with the sealing screws.
  • Page 193 Chapter 4 Maintenance Drain fluid from the chambers. a On the standby screen, select , <7 Maintenance menu>, <5 Drain menu> and <1 Eluent A> in that order. Menu • Fluid is drained from the eluent A chamber. • After completion, the [Drain menu] screen will appear again. b Select <2 Eluent B>.
  • Page 194 Before/After Extended Periods of Disuse c Remove the eluent A chamber from the holder and pull it to the front 2 to 3 cm. IMPORTANT: Remove and clean one chamber at a time to prevent confusion. Holder NOTE: Do not pull the cords or tubes excessively when pulling out the chambers.
  • Page 195 Chapter 4 Maintenance Wash the eluent tubes. a Add a small volume of distilled water to an empty aluminium pack and rinse the inside. • Use the aluminium packs (supplied) for maintenance when the instrument is not to be used for extended periods of time.
  • Page 196 Before/After Extended Periods of Disuse 10 Drain distilled water from the tubes. a Remove the bottle caps with nozzle from the aluminium packs. • Place the nozzles on the gauze. b Discard all of the distilled water in the aluminium packs. NOTE: ...
  • Page 197 Chapter 4 Maintenance 13 Drain distilled water from the tubes. a Discard all of the distilled water from the beaker in which the bottle cap with nozzle for hemolysis washing solution was placed. b On the standby screen, select , <7 Maintenance menu>, <5 Drain menu> and <4 Hemolysis washing Menu solution>...
  • Page 198: Starting Up The Instrument After Extended Periods Of Disuse

    Before/After Extended Periods of Disuse 4.6.2 Starting Up the Instrument After Extended Periods of Disuse Follow the instructions described below to start up the instrument after one week or more of disuse. Set the eluent packs and hemolysis washing solution bottle. a Place the eluent A, B and CV packs on the bottle tray.
  • Page 199 Chapter 4 Maintenance Turn on the power. a Plug the power cord into an outlet. Standby switch b Press the “–” side of the main power switch. c Press the standby switch to turn on the power. Main power switch Set the date and time.
  • Page 200 Troubleshooting Chapter 5 This chapter describes actions you should take if warnings, errors or troubles occur. It also describes what to do if eluent packs are attached to the wrong nozzles or if the column tubes are damaged. If a Warning Occurs ..................5-2 5.1.1 From Warning Occurrence to Remedy..............5-2 5.1.2...
  • Page 201: Chapter 5 Troubleshooting

    Chapter 5 Troubleshooting If a Warning Occurs Warnings call your attention to operations required during instrument use via alarms, warning codes, icons and messages. Measurement may be interrupted by some warnings, but the measurement results of aspirated sample are reported when possible. Remeasure samples for which measurement results were not obtained due to a warning, after completing the necessary action.
  • Page 202: Causes And Remedies

    If a Warning Occurs 5.1.2 Causes and Remedies  Wear protective gloves to prevent exposure to pathogenic microbes before any operation that may expose you to samples.  Discard used samples and protective gloves in accordance with local regulations for biohazardous waste.
  • Page 203 Chapter 5 Troubleshooting W:010 The STAT port is not set in place. Set STAT port as instructed in manual and retry measurement. Cause  The STAT port is not set in the correct position. Remedy a Press to clear the warning. b Push the STAT port in the direction of the arrow near “PUSH”...
  • Page 204 If a Warning Occurs W:024 HbA0 retention time W:025 Retention time (Variant mode only) Cause  Fluid is leaking from the eluent tubes or fluid pump.  Air bubbles have formed in the fluid pump check valve or optical unit cell. ...
  • Page 205 Chapter 5 Troubleshooting W:045 Temperature is outside range W:046 W:047 Cause  The room temperature is outside the measurement environment temperature range of between 10°C and 30°C.  The temperature controlling unit did not operate properly. Remedy a Press to clear the warning. b Adjust the room to a temperature between 10°C and 30°C.
  • Page 206 Reattach the barcode label to the correct position (see page 2-19) and retry measurement. Or, enter the ID with the numeric buttons (see page 1-44). c Set sample tubes in sample racks with the barcode labels facing the rear (away from the ARKRAY logo) of the rack.
  • Page 207 Chapter 5 Troubleshooting W:091 Leak below dil. container Cause  Fluid is spilling from the eluent pack or hemolysis washing solution bottle.  The tube inside the instrument is disconnected or improperly connected.  The dilution container or washing container is clogged. Remedy a Press to clear the warning.
  • Page 208: If An Error Occurs

    If an Error Occurs If an Error Occurs Errors occur due to problems with the power supply, memory, connections or parameter settings, and are indicated by alarms, error codes and messages. Measurements are interrupted by errors, but the measurement results of aspirated sample are reported when possible.
  • Page 209: Causes And Remedies

    Chapter 5 Troubleshooting 5.2.2 Causes and Remedies  Wear protective gloves to prevent exposure to pathogenic microbes before any operation that may expose you to samples.  Discard used samples and protective gloves in accordance with local regulations for biohazardous waste. E:100 Version change Cause...
  • Page 210 If an Error Occurs E:111 HbA1c STD. sol. loading Cause  Dummy samples or standard solutions are improperly set in the calibration rack. Remedy a Press to clear the error. b Properly set the dummy samples and standard solutions in the calibration rack and retry calibration (see page 2-38).
  • Page 211: If Trouble Occurs

    Chapter 5 Troubleshooting If Trouble Occurs Serious problems that occur with the electrical circuits, measurement unit, drive unit or other parts of the instrument are indicated by alarms, trouble codes and messages. Measurements are interrupted by trouble, but the measurement results of aspirated sample are reported when possible.
  • Page 212: Causes And Remedies

    If Trouble Occurs 5.3.2 Causes and Remedies  Wear protective gloves to prevent exposure to pathogenic microbes before any operation that may expose you to samples.  Discard used samples and protective gloves in accordance with local regulations for biohazardous waste. T:200 - T:209 Flash ROM Cause...
  • Page 213 Chapter 5 Troubleshooting T:332 - T:336 Sample introduction flow Cause  The piercing nozzle is broken.  The piercing nozzle is clogged.  A tube is disconnected or improperly connected.  The dilution container or washing container is contaminated.  The dilution container or washing container is clogged. ...
  • Page 214 If Trouble Occurs T:354 Sample introduction Cause  Five consecutive samples had insufficient volume for measurement.  Hemolysis sample was measured with a rack for whole blood sample.  The piercing nozzle is clogged.  The dilution container or washing container is clogged. ...
  • Page 215 Chapter 5 Troubleshooting T:403 - T:411 Temperature control Cause  The room temperature is outside the measurement environment temperature range of between 10°C and 30°C.  The temperature controlling unit did not operate properly. Remedy a Press to clear the trouble. b Adjust the room to a temperature between 10°C and 30°C.
  • Page 216 If Trouble Occurs T:472 - T:478 Temperature control Cause  The room temperature is outside the measurement environment temperature range of between 10°C and 30°C.  The temperature controlling unit did not operate properly. Remedy a Press to clear the trouble. b Adjust the room to a temperature between 10°C and 30°C.
  • Page 217 Chapter 5 Troubleshooting T:601 Cannot read rack ID Cause  The rack detection sensor did not operate properly. Remedy a Press to clear the trouble. b Load the sample rack properly and retry measurement. c If the trouble persists, turn off the power and contact your distributor. T:602 Measurement-side lever Cause...
  • Page 218 If Trouble Occurs T:801 - T:804 Two-way communication T:807 - T:810 Cause  The communication cable of the external device is disconnected or improperly connected. Remedy a Press to clear the trouble. b Properly connect the communication cable. c If the trouble persists, turn off the power and contact your distributor. T:811 No matching ID Cause...
  • Page 219: Abnormal Result Messages

    Chapter 5 Troubleshooting Abnormal Result Messages The following messages appear on the display if inaccurate measurement results are obtained. Measurements will continue. Results Meas No. 0001 Port No. 0001 012345678901234567 S-A1c retention time (early) Abnormal result message Temperature control Cause •...
  • Page 220 Abnormal Result Messages Drift baseline Cause • The baseline drifted more than the threshold value. Noise detected Cause • Noise was detected in the chromatogram. Duplex peaks Cause • Two or more peaks were detected for either HbF, L-A1 or S-A1 Hb: Low value Cause •...
  • Page 221: If This Happens

    Chapter 5 Troubleshooting If This Happens 5.5.1 If the Instrument Does Not Start Up (Replacing Fuses) If the instrument does not start up after turning on both the main power switch and standby switch, there is a possibility that a fuse has blown. The instrument has a pair of fuses and they can be replaced from the rear panel. Replace whichever is blown.
  • Page 222 If This Happens Remove the fuse holder. a Pop open the fuse holder cover by working a flat-head screwdriver under the tab (dotted area in the figure). b Pull the fuse holder straight to the front. Fuse holder Replace the fuse. a Remove the blown fuse from the fuse holder and set a new fuse.
  • Page 223: Replacing The Column Tubes

    Chapter 5 Troubleshooting Turn on the power. a Plug the power cord into the power input terminal on the rear panel. b Plug the power cord into an outlet. c Press the main power switch on the rear panel to turn on the main power. d Press the standby switch to turn on the power.
  • Page 224 If This Happens Blot up liquid in the leak tray. a Blot up all liquid in the leak tray below the column with cotton swabs. Replace the tubes. a Turn the push screw of the damaged tube by hand to remove the tube.
  • Page 225 Chapter 5 Troubleshooting Install the column. a Install the column removed in step 1 to its original position. • See steps 4-a to 8-a in “4.2.4. Replacing the Column” on page 4-12. Complete maintenance. a Press Finish Column (2500) 10-06-2010 10:00 REFERENCE: The message “W:062 Front or maintenance cover is open.”...
  • Page 226: If Eluent Packs Are Incorrectly Attached

    If This Happens 5.5.3 If Eluent Packs Are Incorrectly Attached If you attach the bottle cap (with nozzle) of one eluent to the wrong type of eluent pack, clean the nozzle and chamber inside the instrument, then attach the bottle cap correctly. Eluents A, B and CV differ in composition, so changing nozzles without first cleaning them will cause mixing of eluents, producing inaccurate measurement results.
  • Page 227 Chapter 5 Troubleshooting Turn off the power. a Press the standby switch to turn off the power. Clean the chamber. a Clean the emptied chamber. • See steps 7-a to 8-c in “4.6.1. Preparing the Instrument Before Extended Periods of Disuse” on page 4-46. •...
  • Page 228 Appendix Chapter 6 This chapter gives you examples of printed reports on the instrument’s parameter settings and diagnosis results, and also lists measurement terminology. An index is provided at the end of this chapter. Printed Report Examples ................6-2 6.1.1 Current Parameter Settings................6-2 6.1.2 Accuracy Control Reports .................6-4...
  • Page 229: Chapter 6 Appendix

    Chapter 6 Appendix Printed Report Examples This section gives you examples of printed reports on the instrument’s parameter settings and diagnosis results. 6.1.1 Current Parameter Settings You can view the current parameter settings for timers, column pressure unit, the printer and others. REFERENCE: Printing instructions: See “3.6.5.
  • Page 230 Printed Report Examples Measurement number setup Measurement start number [Continue from previous batch 1 Measurement start number setting Meas No. [Assign to samples Measurement number setting ======================== HbA1c measurement setup Control expected values (mmol/mol) < 0> < 0> Control expected values Control measurement count HbA1 control measurement:...
  • Page 231: Accuracy Control Reports

    Chapter 6 Appendix 6.1.2 Accuracy Control Reports Accuracy control reports show statistical information on HbA1 control measurements and sample measurements for a specified period of time. REFERENCE: Printing instructions: See “3.7.3. Printing Accuracy Control Reports” on page 3-31. Example: Accuracy control Var.&...
  • Page 232: Optical Unit Monitoring Results

    Printed Report Examples 6.1.3 Optical Unit Monitoring Results Optical unit monitoring results show the changes in optical unit light absorption over the last 10 minutes. REFERENCE: Printing instructions: See “3.7.4. Printing Optical Unit Monitoring Results” on page 3-32. Example Optical unit light absorption 10-06-2010 10:00 Print date Serial No.
  • Page 233: Analysis Section Check Measurement Results

    Chapter 6 Appendix 6.1.4 Analysis Section Check Measurement Results A chromatogram is printed out each time hemolysis washing solution is measured during analysis section check. REFERENCE: Printing instructions: See “3.7.5. Performing Check Measurement for the Analysis Section” on page 3-33. Example Analysis section check Var.
  • Page 234: Hba1

    Printed Report Examples 6.1.5 HbA1 Reproducibility Test Results A chromatogram is printed out each time sample is measured during HbA1 reproducibility tests. Diagnosis results are also printed out after the test. REFERENCE: Printing instructions: See “3.7.6. Testing HbA1 Reproducibility (Whole Blood Sample)” on page 3-34 and “3.7.7.
  • Page 235: Reagent Information Report

    Chapter 6 Appendix Example: Diagnosis results HbA1c reproducibility test Fast Current measurement mode 10-06-2010 10:00 Print date HbA1c Result obtained by each measurement Mean value of measurement results Mean 33.1 0.79 Difference between maximum and minimum measurement results S.D. 0.03 Standard deviation C.V.
  • Page 236: Glossary

    Glossary Glossary  Batch A batch is a group of samples measured continuously. In an actual operation, a batch means any number of samples measured after the button has been pressed and until the standby screen appears again.  Measurement number A measurement number is a 4-digit code (0000 to 9999) that identifies each measurement result.
  • Page 237 Chapter 6 Appendix  Port number A port number is a 4-digit code (0000 to 9999) that identifies the port in which sample is set. The last digit indicates the port position (the corresponding number is marked on the top face of the sample rack). Port 10 is indicated as “0”. The first three digits are a sequential number assigned to the sample racks loaded onto the sampler: the first rack on the sampler is indicated as “000”...
  • Page 238 Glossary Loop transportation Up to 100 samples can be measured continuously by setting 5 racks each on the rack loading and unloading sides of the sampler and circulating these racks. Be sure to place the start rack at the first position of a batch, and normal racks, in the remaining area (numbered 2 to 10 in the figure below).
  • Page 239: Performance Characteristics

    Chapter 6 Appendix Performance Characteristics 6.3.1 Analytical Performance 1) Trueness Variant mode JCCRM411 Difference between the measured (certified reference material) value and the certified value Level 1 0.12% Level 2 0.11% Level 3 0.10% Level 4 0.03% Level 5 0.11% Fast mode JCCRM411 Difference between the measured...
  • Page 240: Clinical Performance

    Glossary 4) Interference Substance Test concentration with no significant interference Carbamylated Hb (Sodium Cyanate) 15mg/dL Aldehyde Hb (Acetaldehyde) 25mg/dL Labile A1c (Glucose) 2000mg/dL Bilirubin, conjugated 100mg/dL Bilirubin, unconjugated 100mg/dL Ascorbic Acid 200mg/dL 5) Investigation of Variant Hb All samples containing HbS or HbC that were measured were correctly recognized by Variant mode. 6) Method comparison Variant mode Correlation coefficient...
  • Page 241: Index

    Chapter 6 Appendix Index abnormal result D1.....................1-15 print .................. 3-27 D2.....................1-15 printed report..............2-47 DATA OUT terminal ............... 1-15 abnormal result message ............5-20 date accessories.................. 1-8 enter..................1-44 accessory case ................1-10 set ..................3-22 accuracy control report diagnosis................... 3-29 print ..................
  • Page 242 Index relocate ................1-35 unpack ................1-7 Fast mode ................. 2-14 internal barcode reader............. 1-14 features ..................1-3 FEED button ................1-41 flow leak tray test individual flow circuit ..........3-30 column................1-14 test the whole flow system..........3-29 dilution container ............. 1-14 front cover ................
  • Page 243 Chapter 6 Appendix number precautions ...............2-11 correct ................1-44 prepare................2-16 enter.................. 1-43 STAT measurement ............2-26 sample container.................2-3 sample cup..................2-3 sample rack................. 2-4 one-way transportation............. 6-10 sample rack transportation ............6-10 operator panel..............1-12 1-41 sample tube................. 2-3 optical unit monitoring result sample tube spinning unit ............
  • Page 244 Index wash automatically after measurement......4-28 unlock the instrument............... 1-17 unpack ..................1-7 user-specified coefficient ............3-7 Variant mode................2-14 W....................1-15 warm-up ................... 1-30 warning ..................5-2 causes and remedies............5-3 delete history..............3-21 from occurrence to remedy ..........5-2 print history..............

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