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.
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.
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 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 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...
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...
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...
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...
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.
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...
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...
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...
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)
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.
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 (×...
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. ...
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, ×...
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 •...
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.
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.
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.
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...
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”...
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...
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 :...
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...
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...
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. ...
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.
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.
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: •...
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.
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 ...”...
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.
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.
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 •...
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.
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 •...
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.
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. ...
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.
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>...
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.
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.
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”...
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.
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. •...
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.
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...
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.
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.
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.
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. ...
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.
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.
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.
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.
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...
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.
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.
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, •...
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.
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.
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>...
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.
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.
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.
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.
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>...
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.
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.
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.
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 •...
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.
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”...
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...
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 ().
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.
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.
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.
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...
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...
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. •...
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.
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.
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.
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.
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.
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.
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 •...
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.
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. •...
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.
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>...
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>...
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...
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.
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.
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.
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).
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.
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...
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 •...
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.
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.”...
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...
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:...
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.&...
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.
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.
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.
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.
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).
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..............
Need help?
Do you have a question about the ADAMS A1C HA-8180V and is the answer not in the manual?
Questions and answers