Quick Response Guide. AU5400 Chemistry Analyzer. For In Vitro Diagnostic Use. BM0562Q November, 2009

Transcription

1 Quick Response Guide AU5400 Chemistry Analyzer For In Vitro Diagnostic Use BM0562Q November, 2009 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821

2 Copyright 2009 Beckman Coulter Inc. All rights reserved. Printed in the United States of America. AU5400 is a registered trademark of Beckman Coulter Corporation, Beckman Coulter Inc., or their affiliated entities. No part of this publication may be reproduced in any form or by any means without prior written permission of Beckman Coulter Inc. While every precaution has been taken during document preparation, Beckman Coulter Inc. assumes no responsibility for errors or omissions. Neither is any liability assumed for damages resulting from the use of the information contained herein. BECKMAN COULTER INC. 250 S. Kraemer Blvd. Brea, CA This guide was written to comply with Clinical and Laboratory Standards Institute Protocols (CLSI) guidelines for Clinical Laboratory Procedure Manuals; however, each laboratory may need to modify and/or add procedures to meet the laboratory requirements of CLSI. The AU5400 is ISO13485 certified. Design and production adheres to ISO13485 international quality standards. The AU5400 has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy. If the instrument is not installed and used in accordance with the instruction manual, harmful interference to radio communications may result. Operation of this equipment in a residential area is likely to cause harmful interference in which case the users will be required to correct the interference at their own expense. FCC Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment.

3 Document Change Notification AU5400 Quick Response Guide This document will be revised as additional information becomes available. Document Revision Number Software Version Date 1. N/A December, 2000 New Manual Description 2. N/A July 2007 Update 186 Complete revision 3. N/A August 31, 2007 Replaced Table of Contents 4 n/a November, 2009 QRG Re-branded to Beckman Coulter Inc Update 226: Please replace or add the attached pages in the appropriate chapters: Document Change Notification: Pages DCN- 1 DCN-1 AU5400 Quick Response Guide Rev 4, 11/2009

4 AU5400 Software Chart Main Menu (R) Routine (P) Parameter (A) Auxiliary (M) Maintenance (U) User (L) Logout Pull-Down Menu Submenu (S) Start Condition (T) Test Requisition > (R) Reaction Monitor (C) Calibration Monitor > (P) Photocal Monitor (Q) QC Monitor > (D) Data Management > (I) Data Report > (T) Test Requisition (N) Normal (R) Repeat (Q) QC (C) Calibration (S) Retrieve Repeat Data (C) Calibration Monitor (S) Calibration Curve (T) Calibration Trace (B) Reagent Blank Monitor (Q) QC Monitor (D) Daily Control (S) Day to Day Control (T) Twin Plot (E) Data Edit (D) Data Management (D) Data Edit (C) Data Correction (W) Repeat Data Verification (I) Data Report (R) Report (D) Data List (N) Online (Y) Common Test Parameters > (I) Specific Test Parameters (H) Inter-related Tests > (R) Repeat Parameters > (Q) QC Control > (B) Calibration > (O) Online (F) Format > (C) Special > (S) System > (M) Comment Masters (Y) Common Test Parameters (A) Test Name (B) Profile (C) Round (H) Inter-related Tests (A) Calculated Tests (H) Checked Tests (B) Sample Blank (R) Repeat Parameters (C) Repeat Common (I) Repeat Specific (Q) QC Control (C) QC Common (I) QC Specific (B) Calibration (C) Calibrator (I) Calibration Specific Parameter Menu Continued (F) Format (P) Printer (S) Requisition Format (R) Report Format (L) List Format (C) Special (C) Contamination Parameters (D) Data Check Parameters (S) System (O) Option (S) System (P) Auto Power On (W) Password (L) Login Name (U) User Menu (S) Data Statistics (C) Correlation Chart (H) Histogram (R) Reagent Consumption (P) Parameters Management (V) Calibration Verification (B) Standby Set (D) Data Operation > (A) ANL Maintenance (C) Consumable Management (P) Periodic Maintenance (M) Maker Maintenance > (D) Data Operation (F) FD Data Management (T) Set Date & Time (D) Retrieve Data Base (O) Offline Output (M) Modem (M) Maker Maintenance (V) Program Version (A) ANL Diag (I) ISE Diag (L) Alarm Log (F) File Management User defined. This menu is enabled in [Parameters], [System], [User Menu]. User defined. This menu is enabled in [Parameters], [System], [Login Name].

5 AU5400 TM Software Chart Stop/standby icon Feeder stop icon Pause icon Analysis start icon Mode display Pull-down menu STANDBY (R) Routine (P) Parameters (A) Auxiliary (M) Maintenance (U) User (L) Logout System status icons Alarm help icon Operation help icon System date and time? 2000/01/01 10:10 (S)Start Condition (T)Test Requisition (R)Reaction Monitor (C)Calibration Monitor (P)Photocal Monitor (Q)QC Monitor (D)Data Management (A)Data Report (R)Report (D)Data List (N)Online Sub-menu Menu bar Guidance message display area Alarm message display area ALARM CLEAR

6 Table of Contents Table of Contents Introduction...iii Conventions Used in this Manual...iv General Operating Procedures... 1 Preparing for Analysis...5 Starting the AU Starting the ISE Performing Calibrations and a Reagent Blank Performing a Calibration and Reagent Blank...12 Performing a Calibration with Barcodes...13 Quality Control Analysis Requisitioning for QC Samples...14 QC Analysis with Barcodes...14 Starting Normal Analysis Entering Individual Requisitions (Routine and Emergency)...16 How to Requisition by a Profile (Routine and Emergency)...17 Entering Group (Batch) Requisitions (Routine and Emergency)...18 Downloading Requisitions from a Host Computer...19 Real-time Downloading of Requisitions from a Host Computer...19 Preparing Samples and Racks Flex Racks...27 Placing Racks on the Analyzer...29 Changing Reagents How to Fix a Reagent Position Adding Wash Solution How to Place the Sample Pre-dilution Bottle Starting Analysis...39 Obtaining Results...41 Checking Results Checking Quality Control Checking the Daily Variation Chart...43 Checking the Day-to-Day Variation Chart...44 Performing a Repeat Run How to Print a Repeat Run Work List...45 How to Modify the Repeat Work List:...46 How to Perform an Auto-Repeat Run...47 How to Perform a Manual Repeat Run...47 Reporting Repeat Results or Original Results...48 How to Reprint Reagent Blank, Calibrator, QC and Patient Data AU5400 Quick Response Guide Rev. 3, 08/31/07 i

7 Finishing Analysis...51 Ending ISE Analysis...51 Ending Analyzer Analysis...52 As-Needed Tasks...53 Checking Analysis Conditions Maintenance and Inspection Move a Reagent to Another Unit: Processing Emergency Samples Pausing Analysis Stopping the Rack Feed Unit Creating a New Profile Changing QC Ranges Changing Calibrator Set Points Turning on/off the Sample ID Barcode Reader Programming the Auto Power On Creating a User Menu Standby Mode Programming a New Test How to Save or Load Parameters to a Floppy Disk Troubleshooting...79 Data Error Flags Non Fatal Errors (Yellow) Fatal Errors (Red) Performing a Stop or an Emergency Stop During Analysis Performing a Stop Function...86 Resetting the System After a Stop...86 Performing an Emergency Stop...87 Recovering from an Emergency Stop or Power Loss Recovering from a Cuvette Wheel Overflow What causes an overflow...90 Recognizing a overflow...91 Recovering from a overflow...92 After the overflow problem is fixed...92 ii Rev. 3, 08/31/07 AU5400 Quick Response Guide

8 Introduction This quick response guide describes basic system operations. It contains general information on preparing for analysis, starting analysis and obtaining results. It also describes other frequently used procedures performed during daily routine operations. For detailed procedures, refer to your AU5400 User s Guide. AU5400 Quick Response Guide Rev. 3, 08/31/07 iii

9 Conventions Used in this Manual The following conventions are used throughout this document: Bold: Clearly displays function keys. Example: F1 Exit [Brackets] Shows software menus Example: [Routine], [Test Requisition], [Normal] QUOTES Shows the button to select in software. Example: CLOSE iv Rev. 3, 08/31/07 AU5400 Quick Response Guide

10 General Operating Procedures The AU5400 is available in two configurations, the AU5421, which features two module units, and the AU5431, which features three module units. Adding the optional ISE unit, Auto Repeat unit, or both can further customize the AU5400 for specific laboratory requirements. To obtain accurate results, calibrate the analyzer based on the manufacturer s calibration stability claim after system start-up. This updates the calibration curve. Quality control testing should be performed in accordance with regulatory requirements and each laboratory s standard procedure. During operation of the AU5400, at least two levels of control material should be tested a minimum of once a day. In addition, these controls should be performed after calibration, with each new lot of reagents, and after specific maintenance or troubleshooting steps described in the Maintenance Chapter or Troubleshooting Chapter located in the AU5400 User s Guide. System Start-up For detailed procedures, refer to the section called Starting the AU5400. Creating Calibration Curves To obtain accurate results after system start-up, calibrate the analyzer based on the manufacturer s calibration stability data. This updates the calibration curve. Based on calibration curves, the concentration value is calculated from the absorbance (optical density [OD]) of the sample measured during analysis. To create calibration curves: 1. Requisition for calibration analysis by selecting [Routine], [Test Requisition], [Calibration]. 2. Use the blue rack for reagent blanks. Set a deionized water sample in position #1 for serum, position #10 for urine, or position #4 for other fluids. Place the calibrator solution in the yellow rack. 3. Start analysis. 4. While the reagent blanks and calibrators are being analyzed, check that no calibration errors occur. 5. Confirm that the reagent blank value was updated by selecting [Routine], [Calibration Monitor], [Reagent Blank Monitor]. 6. Confirm that the calibration factors are updated for each calibrated test by selecting [Routine], [Calibration Monitor], [Calibration Curve]. AU5400 Quick Response Guide Rev. 2, 07/06/07 1

11 Measuring Quality Control Samples After updating the calibration curves, perform QC in accordance with regulatory requirements and each laboratory s standard procedure. During operation of the AU5400, at least two levels of control material should be tested a minimum of once a day. In addition, these controls should be performed after calibration, with each new lot of reagents, and after specific maintenance or troubleshooting steps described in the Maintenance Chapter or Troubleshooting Chapter located in the AU5400 User s Guide. Quality control is performed to check for variations in the data. Measure the control sample by performing the following operation: 1. Requisition quality control by selecting [Routine], [Test Requisition], [QC]. 2. Place the green rack with the control sample or barcoded control samples on the rack feeder unit. 3. Start analysis. 4. While the QC is being analyzed, check that there are no errors in the QC data. 5. Using [QC Monitor] from the [Routine] screen, check the daily variation chart and the day-to-day variation chart for abnormal data. Commercial Control Sera for the ISE When using commercial control sera for the ISE, be sure to consider the following: Commercial control sera contains additives for regulating the concentration of components, as well as various preservatives. If these kinds of control sera are measured using an ion-selective electrode, the added materials may adversely affect the electrode, and could cause measurement errors including abnormal data. It is possible that the effects of preservatives on results may change over time. 2 Rev 2, 07/06/07 AU5400 Quick Response Guide

12 Control sera recommended by Beckman Coulter are listed below. Changes in added components (especially preservatives) are likely in the future. Recommended Control Sera Control sera Manufacturer Multiqual CHEMTRAK Platinum Caution Bio-Rad Microgenics/MAS The following items affect measurement: The K and Cl results are not affected by bilirubin, but small positive errors will occur in the Na results. Positive errors will occur in the Cl results due to other halogen ions (Br, I). If the hematocrit value for the total blood sample is 65% or more, positive errors may be recognized in the K results. The measurements are not affected by ascorbic acid. Grossly lipemic samples may not show and inappropriate decreased in sodium, potassium, and chloride results due to volume displacement. Such samples should be ultracentrifudged and the analysis performed on the inf ran at ant (middle of clear layer). When measuring plasma samples, use Beckman Coulter recommended anticoagulants. Any other anticoagulants could cause measurement errors. In order to prevent fluctuations due to the sample evaporation, tightly cap and properly store samples. Measuring the Patient Sample (Normal Analysis) On the operation screen, measurement of the patient sample is called normal analysis. See Also For more information on normal analysis, refer to the section called Starting Normal Analysis. Obtaining Appropriate Analysis Results After starting analysis, check the quality-control charts, and patient results on the printout. Periodically check results after the sample has been analyzed. Shutting Down the Analyzer AU5400 Quick Response Guide Rev. 2, 07/06/07 3

13 After all analysis is complete, perform an END PROCESS. This turns off the sub-power to the system. The main power remains ON to maintain the temperature of the reagent refrigerators and reaction bath (incubator). Periodically, the ISE performs a prime cycle. After the END PROCESS, close the main DI water valve. Handling Alarms If an error occurs while using the system, an alarm message is displayed on the monitor screen. Use the online help to correct the problem 4 Rev 2, 07/06/07 AU5400 Quick Response Guide

14 Preparing for Analysis Before starting analysis, review the sections listed below: Contents Starting the AU Starting the ISE Performing Calibrations and a Reagent Blank Performing a Calibration and Reagent Blank...12 Performing a Calibration with Barcodes...13 Quality Control Analysis Requisitioning for QC Samples...14 QC Analysis with Barcodes...14 Starting Normal Analysis Entering Individual Requisitions (Routine and Emergency)...16 How to Requisition by a Profile (Routine and Emergency)...17 Entering Group (Batch) Requisitions (Routine and Emergency)...18 Downloading Requisitions from a Host Computer...19 Real-time Downloading of Requisitions from a Host Computer...19 Preparing Samples and Racks Flex Racks...27 Placing Racks on the Analyzer...29 Changing Reagents How to Fix a Reagent Position Adding Wash Solution How to Place the Sample Pre-dilution Bottle AU5400 Quick Response Guide Rev. 2, 07/06/07 5

15 Starting the AU5400 Perform the following start-up and daily maintenance procedures before beginning analysis. The AU5400 is supplied with main power and subpower buttons. The main power is turned on with the white reset button. In an emergency, perform an emergency stop procedure to turn off the main power. Refer to Performing an Emergency Stop located in the Troubleshooting section. The sub-power is turned on with the green on button. The sub-power is turned off by pressing the END PROCESS on the keyboard. To start the AU5400, both the main and sub-power must be turned on. The main power should be on at all times except in an emergency! The main power supplies power for refrigerators, incubators, and the automatic priming of the ISE. Instruction If a sample is centrifuged in a primary tube to be analyzed on the AU5400 system, check that there is sufficient serum for analysis, in addition to the dead volume required for sample detection. If the serum height in the sample cup is less than the limit, transfer the serum into a smaller sample cup, then start analysis. Otherwise, if the blood cells under the serum in the cup are aspirated, analysis and dispense abnormalities could occur. Starting the AU5400 If the AU5400 system is off, perform the following procedures. If the AU5400 is on and a new index needs to be created, select [Routine], [Start Conditions], then skip to step 4. For more information about the [Start Condition] screen, refer to the Software Chapter located in the AU5400 User s Guide. 1. Open the deionized water supply valve. 2. Press the green on button: Initialization occurs, the lamp comes on, and the software is loaded. 3. After pressing the green on button, the [Start Condition] screen will appear in a few minutes. 4. Change the data index, by selecting F4: Set. Use the pull-down menu to select 1. Current time to create a new index. 5. Select F2: Exit. The [Start Condition] screen briefly displays a message notifying you that the index is being changed. 6 Rev 2, 07/06/07 AU5400 Quick Response Guide

16 Note The system security pop-up screen appears only if the analyzer options are activated. Enter the log-in name and password, only if the log in security option is activated, then press ENTER.. See Also For information about creating passwords, refer to the Software Chapter located in the AU5400 User s Guide. 6. The window closes and the main screen appears. 7. Perform the following daily maintenance procedures. Refer to the Maintenance Chapter located in the AU5400 User s Guide for detailed procedures. Check the sample and reagent syringes on each unit for leaks or condensation. Inspect the concentrated wash solution level in detergent tank B. Analysis pauses and a warning message displays on screen if there is insufficient concentrated wash solution. Check the sample probes, reagent probes, and mix bars on each unit. The probes should be straight and clean. The mix bars should be clean with no chips in the Teflon. Replace the probes if they are bent and replace the mix bars if they are chipped. Select the following menus: [Maintenance], [ANL Maintenance], A/ Prime Washing Line. Press the Diag switch on unit 1. Verify that a thin, straight stream of DI water is dispensed from the R11 and R21, S1 and S2, then R12 and R22 probes. It may be necessary to press the Diag switch several times to watch all of the probes dispense. Verify the mix bar unit and wash nozzle unit perform a sequence without errors. If the probes or mix bars appear dirty, clean them with an alcohol prep. Press the Diag switch on unit 2, watch the probes dispense, mix bar unit, and wash nozzle unit. Press the Diag switch on unit 3, watch the probes dispense, mix bar unit, and wash nozzle unit. Verify that the printer is online and that there is enough printer paper. Change the DI water in the pre-dilution bottle daily on each unit. Prepare the sample probe wash solution: Verify the two 60-ml bottles by the sample probes on each unit contain 2% Wash AU5400 Quick Response Guide Rev. 2, 07/06/07 7

17 Solution. Automatic washing of the sample probe occurs when START is selected from Standby, and at the end of Measure 2 before the analyzer goes back to Standby. The sample probes go into each 60-ml bottle 3 times. See Also For detailed information on analyzer maintenance, refer to the Maintenance Chapter located in the AU5400 User s Guide. 8. Perform a Reagent Volume Check. Look at how many tests remain in each bottle and load any necessary reagents. If new bottles are added, perform another check. A. Verify that fixed reagents are placed in the correct positions in the compartment. B. The pre-dilution bottle #49 is checked as part of the volume check even if the pre-dilution option is not in use. Replace with fresh DI water daily. Press the bottle down into the compartment completely. C. Select [System Status], [Reagent Status]. Press F5: Check Start, then select Check for All Positions. The system defaults to check all units. D. Verify that the refrigerator lids are on. Select the START button and select Yes to start the check. E. Verify Checked and Reagent of Group displays in blue for all units. Check the status of the reagents by selecting F7: Test Display Detail and review all units. If yellow or red appears, refer to Reviewing reagent position errors in [System Status], [Reagent Status] in the Software Chapter located in the AU5400 User s Guide. See Also For detailed information on the [Reagent Status] Screen, refer to the Software Chapter located in the AU5400 User s Guide. 9. Determine which tests need reagent blanks and/or calibrations. Select F7: Test Display, select DETAIL. Reagent bottle information displays. Tests with expired calibrations display in yellow with a comment Cal Expired. 8 Rev 2, 07/06/07 AU5400 Quick Response Guide

18 See Also For detailed information on [System Status], refer to the Software Chapter located in the AU5400 User s Guide. 10. For reagent position errors, refer to [System Status], [Reagent Status], in the Software Chapter located in the AU5400 User s Guide. After checking the list, select the Close button. See Also For detailed information on starting analysis, refer to the section called Starting Analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 9

19 Starting the ISE The dual ISE consists of 2 flowcells. Parts are labeled Cell 1 and Cell 2 on the ISE unit. The system automatically alternates between cell 1 and cell 2 when calibrating, cleaning, and processing samples. Data displays and prints as Na/1, Na/2, K/1, K/2, Cl/1, and Cl/2. Perform the following ISE start-up and daily maintenance procedures before beginning analysis. For information on commercial control serum for the ISE, refer to general operating procedures. Starting the ISE Unit 1. Verify the ISE reagents are in date. (90-day open bottle stability). Refer to the package insert for information on open bottle stability. 2. Check the ISE syringes for leaks/condensation: Sample syringe Probe wash syringe Buffer cell 1 and 2 syringes Note The liquid level of the tanks should be above the liquid level sensor. If the liquid level is below the sensor level, an alarm will sound. After this alarm occurs, the following number of samples can be processed: approximately 180 for mid standard, 240 for buffer, and 600 for reference reagent. See Also For more information about changing reagents, refer to the Maintenance Chapter located in the AU5400 User s Guide. 3. Check the ISE sample probe dispense: Select [System Status], [ISE Status], F6: Prime. Select G/ Replace Probe & Syringe. Press the ISE Diag switch. Watch as DI water is dispensed from the ISE sample probe. 4. Perform Mid/Ref and Buffer primes. Select [System Status], [ISE Status], F6: Prime. Select D/ Buffer Prime. Press the ISE Diag switch to initiate the prime. 10 Rev 2, 07/06/07 AU5400 Quick Response Guide

20 Verify buffer is dispensed into the pot and buffer syringe operation. Buffer primes through the bypass tubing Select E/ Mid/Ref Prime. Press the ISE Diag switch to initiate the prime Verify mid standard is dispensed into the pot and no bubbles are present in the tubing at the bottom of the flowcell. 5. Check ISE sample probe detergent. Fill the two 60-mL bottles by the ISE sample probe with 2% Wash Solution. Select [System Status], [ISE Status], S-Detergent Tab. Select F5: Check Start. Start Checking? Select the Yes button. If this is not checked after an End Process, an ISE Detergent Unchecked message appears in the Measure Start window. Calibrate the ISE. Select [System Status], [ISE Status], Result Cal Tab. Place serum/urine high and low standards on the labeled positions on the ISE standard solution area. Select F5: ISE Unit Start. Select A/ Calibration for Serum, B/ Calibration for Urine, or C/ Calibration for Serum + Urine. Start Operation? Select the Yes button. Verify the Slope and MID Solution Factor values are in range when the calibration is complete. Slope: 38 to 68 (Cl is negative) Mid Factor: Na = 0.80 to 1.20 K = 0.75 to 1.25 Cl = 0.75 to 1.25 Select F7: Cell Change if necessary to view cell 1 or cell 2 results. Select F8: Type Change if necessary to view urine results. Verify the slope values are consistent on a day to day basis. After checking results, press F2: Exit twice to return to the main screen. See Also For calibration errors, refer to the ISE section of the Troubleshooting Chapter located in the AU5400 User s Guide. For information about replacing electrodes, refer to the Maintenance Chapter located in the AU5400 User s Guide. AU5400 Quick Response Guide Rev. 2, 07/06/07 11

21 Performing Calibrations and a Reagent Blank This procedure explains how to requisition for reagent blanks and calibrators. Reagent blank and calibration requisitions are performed automatically when the calibration is expired, or for new bottles/lot numbers of reagent. Requisition reagent blanks and calibrations as needed. The [Start Condition] Menu displays whether the reagent blank and calibrator have tests requisitioned. For procedures on calibrating the ISE, refer to Starting the ISE Unit. Performing a Calibration and Reagent Blank 1. Select [Routine], [Test Requisition], [Calibration]. 2. At Type select serum, urine, or other. 3. Select F4: Start Entry to requisition using one of the following options: Blue indicates a reagent blank only, yellow indicates All, or reagent blank + calibration. Select a specific test(s) for bottle sequence 1. Profile (P) button for bottle sequence 1 Analyzer Requisition button to reset the requisitions based on expired calibrations or new bottles/lot numbers. Individual Requisition button to order sequenced bottles (1,2,3,4,5) of the same test in Advanced Calibration. Select the All for One Test button to requisition all sequenced bottles of the selected test. Select the All for All Test button to requisition all sequenced bottles for all tests. F6: Change Option to change between calibration and RB only for bottle Sequence 1. F7: Select All Tests to requisition all reagent blanks and calibrators for bottle sequence 1. F8: RB All key to requisition a reagent blank only on all tests for bottle sequence Select the F4: Entry. Verify calibration requisitions. Test names are highlighted in yellow (reagent blank + calibration) or blue (reagent blank only). 5. Repeat steps 2-4 to requisition for another sample type if necessary. 12 Rev 2, 07/06/07 AU5400 Quick Response Guide

22 6. Select F6: Cal to view a picture of the racks and calibrators required. Select the Detailed Inf. button to view the calibrator names and assigned positions. 7. Load the reagent blank(s) in the blue rack and calibrator(s) in the correct yellow rack using the Detailed Inf. button. 8. Select the START key/icon. Performing a Calibration with Barcodes Important The highest calibrator number (From 1-200) must be placed last in the rack. 1. Make sure the calibrator barcode operation option is selected in [Parameters], [Calibration], [Calibrator]. For information on programming a new calibrator, refer to [Parameters], [Calibration], [Calibrator] located in the Software Chapter of the AU5400 User s Guide. 2. From the main screen, select [Routine], [Test Requisition] and [Calibration] in that order. The calibration requisition screen is displayed. 3. Follow steps 2 through 5 from Performing a Calibration and Reagent Blank on the Analyzer located on the previous page. Place the calibrator with the appropriate barcode ID in any position on the yellow rack and start analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 13

23 Quality Control Analysis This procedure explains how to requisition for QC samples. Unlike the calibration requisition screen, the QC requisition screen defaults to perform all the QC tests. This procedure can also be used to delete the QC requisition on tests which do not need QC analysis. Requisitioning for QC Samples 1. Select [Routine], [Test Requisition], [QC]. 2. At Type, select serum, urine, or others. 3. Select F4: Start Entry. Select any tests that do not need QC to remove the blue highlight. Select F8: Deselect All to remove the highlight from all tests. Select the test(s) required for QC analysis. Select the Individual Requisition button to requisition sequenced bottles (1, 2, 3, 4, 5) of the same test. Select the All for One Test button to requisition all sequenced bottles of the selected test. Select the All for All Test button to requisition all sequenced bottles for all tests. 4. Select F4: Entry. Verify QC requisitions. Tests to QC are highlighted in blue. 5. Repeat steps 2-4 to requisition for another sample if necessary. 6. Select F6: QC to view the QC racks and assigned positions. 7. Load the QC in the correct green rack using the Detail Inf. button. 8. Select the START key or Icon. QC Analysis with Barcodes Important The highest QC number (From 1-60) must be placed last in the rack. QC analysis with barcodes can be performed in a green rack. 1. Set sample cups on a green rack in any order. 14 Rev 2, 07/06/07 AU5400 Quick Response Guide

24 2. Place racks on the analyzer. 3. Start analysis. See Also For information on programming QC barcode analysis, refer to Quality Control Analysis located in the Basic Operations Chapter of the AU5400 User s Guide. AU5400 Quick Response Guide Rev. 2, 07/06/07 15

25 Starting Normal Analysis Routine samples must have a requisition for the tests that will be run on each sample. Requisitions can be performed at the AU5400 in this screen, or downloaded from a host computer to the AU5400. Requisitions are processed sequentially by sample number, or by the sample ID number. There are three methods for performing normal analysis requisitions: requisition for individual samples, batch requisition, and batch or real-time downloading from a host computer. If normal analysis is being performed using the ISE unit, select the ISE tests (Na, K, Cl). Profiles can be created to requisition a common group of tests at once. Note If calibration or quality control is required with the normal patient samples (white racks), it is necessary to requisition for calibration and quality control in addition to the normal analysis procedure described here. Entering Individual Requisitions (Routine and Emergency) 1. From the main menu, select [Routine], [Test Requisition] and [Normal]. The screen for requisitioning normal analysis is displayed. 2. Select the following from the type pull-down menu: serum, urine or other. 3. Verify the sample number is correct for the next sample number to be processed on the AU5400. If you are processing emergency samples: Type an E to test samples in the red rack. Use F8: S. No. to select a specific sample number. 4. Press F4: Start Entry. 5. Enter the S. ID (Sample ID or barcode) number if barcodes are in use or for manual entry that appears on the printout. 6. Select the tests to be performed. The test highlights in blue when it is requisitioned. Tests highlighted grey are not operational for the sample type selected. 7. Select F4: Entry. The next sample number is available for requisition. 16 Rev 2, 07/06/07 AU5400 Quick Response Guide

26 8. Select F2: Exit to return to the [Normal] screen. Repeat steps 2-7 for all sample types in use. 9. Optional Step: When all requisitions are performed, select the [Demographics] tab and enter the patient information. 10. After all settings are entered, press F2: Exit. The main screen returns. How to Requisition by a Profile (Routine and Emergency) Profiles can be used when requisitioning individual samples, or when entering group (batch) requisitions. 1. From the main menu, select [Routine], [Test Requisition] and [Normal]. The screen for requisitioning normal analysis is displayed. 2. Select the following from the type pull-down menu: serum, urine or other. 3. Verify the sample number is correct for the next sample number to be processed on the AU5400. If you are processing emergency samples: Type an E to test samples in the red rack. Use F8: S. No. to select a specific sample number. 4. Select F4: Start Entry. 5. Enter a S. ID (sample ID or barcode) number if barcodes are in use or for manual entry that appears on the printout. 6. Select the profile button to open the Select profile window. Select a profile number (1-99) and select OK. 7. Select F4: Entry. 8. Select F2: Exit. Repeat steps for all sample types in use. AU5400 Quick Response Guide Rev. 2, 07/06/07 17

27 Entering Group (Batch) Requisitions (Routine and Emergency) Perform a batch requisition when analyzing the same tests for multiple samples. 1. From the main menu, select [Routine], [Test Requisition] and [Normal]. The screen for requisitioning normal analysis is displayed. 2. Select the following from the type pull-down menu: serum, urine or other. 3. Verify the sample number is correct for the next sample number to be processed on the AU5400. If you are processing emergency samples: Type an E to test samples in the red rack. Use F8: S. No. to select a specific sample number. 4. Press F4: Start Entry. 5. First, select tests individually or by a profile. Tests are highlighted in blue when requisitioned. Tests highlighted grey are not operational for the sample type selected. 6. Select F3: Xn-Enter. Enter the last sample number of the batch, or enter the actual number of samples in the batch. 7. Select the Execute button. The S. No. prompt advances to the next available sample number for requisitioning. If the barcode reader is on, the sample ID numbers increment by one. 8. Press F2: Exit. The main screen returns. 18 Rev 2, 07/06/07 AU5400 Quick Response Guide

28 Downloading Requisitions from a Host Computer To download requisitions from a host computer in real time, the system must be set to Batch in [Parameters] [Online]. The T.R.I. Receive prompt can be set to Real-time, Batch, or none. Set to Batch to manually download requisitions according to the following procedure: 1. Select [Routine], [Test Requisition]. [Normal]. 2. Select F7: Online. The online window displays. 3. At Sample Kind, select the requisition sample type to transfer. Options include routine and emergency for serum urine and other. 4. Move the cursor to Sample No. 5. Enter the sample numbers (not the sample ID numbers!) of the requisitions to download. 6. Select the EXECUTE button. The START RECEIVING window displays 7. Select the YES button. The sample requisition information is downloaded from the host computer. A message displays while the information is downloaded. 8. Select F2: Exit. The main screen returns Note Manual requisitions have a higher priority than online requisitions. Enter the barcode identification in the sample ID field and select the desired tests following test requisition. The system will automatically process the barcoded sample with the revised requisition. Real-time Downloading of Requisitions from a Host Computer To download requisitions from a host computer, the system must be set to Real-time in [Parameters] [Online]. The T.R.I. Receive prompt must be set to Real-time, to automatically download requisitions according to the following procedure: 1. From the main menu, select [Parameters], [Online]. 2. Press F4: Set. AU5400 Quick Response Guide Rev. 2, 07/06/07 19

29 3. Select the pull-down menu in each category on screen to select Realtime at any of the Test Requisition Information fields for automatic downloading by sequence or sample ID. Tip If an online error occurs during real-time online analysis, the analyzer defaults to test profile number 0. Note Manual requisitions have a higher priority than online requisitions. Enter the barcode identification in the sample ID field and select the desired tests following test requisition. The system will automatically process the barcoded sample with the revised requisition. 20 Rev 2, 07/06/07 AU5400 Quick Response Guide

30 Preparing Samples and Racks Before starting analysis, the samples (serum, urine, or other fluids) must be dispensed in the sample cups and placed in the appropriate racks. Follow hospital or laboratory protocol when preparing the samples and racks. The type (color) of rack used is different depending on the purpose of the analysis. Conditions for the Sample Cups The sample cups should be at least 10 mm above the top surface of the rack and have an outer diameter of at least 11.5 mm. If a sample cup is used that does not meet these specifications, analysis may not be performed. Damage to the analyzer could also occur. Prepare the Sample and Dispense it into the Sample Cups 1. Prepare the sample cups. 2. Dispense the serum, urine, or other fluid into the sample cups. Make sure the sample is free of clots. OR 3. Process blood collection tubes according to standard lab protocol. Prepare the Control Serum In order to perform quality control, a control serum should be prepared in advance. Obtain Racks The type (color) of rack will be different depending on the type of sample to be analyzed. The type of sample (routine/emergency) is also defined by the rack type. Rack Types There are six types of racks that are used in this system. A maximum of 10 sample cups can be set into one rack. Blue Rack Use this rack to analyze the reagent blank. This is used for calculating the reagent blank to obtain the OD of the reagent without any sample. A reagent blank must be run in front of each calibration. Place deionized water in the following position(s): AU5400 Quick Response Guide Rev. 2, 07/06/07 21

31 If the sample is serum If the sample is urine If the sample is other (CSF) First position in the blue rack Tenth position in the blue rack Fourth position in the blue rack The blue rack must have a rack ID. Apply label 0001 to run the reagent blank on all units. Apply labels 1001, 2001, and 3001 and load these three blue racks at one time to run a reagent blank on all 3 units simultaneously. Yellow Rack: This rack is used when creating the calibration curves. With calibrated tests, the calibration curves are calculated from the standard solution concentration (known) and OD (obtained from yellow rack analysis). Place standard solutions in the yellow rack in the order of calibrator numbers that were set as parameters. For barcoded analysis, samples can be placed in any order. Important: The highest calibrator number (From 1-200) must be placed last in the rack. The calibrator numbers correspond to the sample positions (1 to 200) in the yellow rack. For example, 1 to 10 are the cal. numbers and sample positions for the yellow rack of ID 1, and 11 to 20 are the cal. numbers and sample positions for the yellow rack of rack ID 2. Serum, urine and other calibrators need to be placed in the correct yellow rack designated by the rack ID and calibrator number. Rack IDs must be run consecutively. Green Rack: Use this rack to analyze quality control samples and barcoded quality control samples. For barcoded analysis, samples can be placed in any order. Important: The highest QC number (From 1-60) must be placed last in the rack. For samples without barcodes, place the control samples in the green rack in the order of the control numbers which were set as parameters. The control numbers correspond to the sample positions (1 to 60) in the green rack. For example: 1 to 10 are the control numbers and sample positions for the green rack of ID 1, and 11 to 20 are the control numbers and sample positions for the green rack of rack ID 2. Serum, urine and other QC need to be placed in the correct green rack designated by the rack ID and QC number. Rack IDs must be run consecutively. 22 Rev 2, 07/06/07 AU5400 Quick Response Guide

32 White Rack: Use this rack to analyze normal patient samples. For barcode analysis, samples can be placed in any order. For sequential analysis, the sample cups are placed in order of the sample number. For rack ID analysis: Rack ID = Sample Number 1 = = = = (Etc. up to Rack ID 400) For all methods, all of the sample cups must have a requisition, or the default profile (#0) will be performed. Red Rack: Use this rack for analyzing emergency samples. Red racks are processed on the bypass belt to the sample aspiration position. Red racks can bypass routine racks on the primary sample transport belt for faster analysis. For barcode analysis samples can be placed in any order. For sequential analysis, the sample cups are placed in order of the sample number. For rack ID analysis: Rack ID = Sample Number 1 = = = = (Etc. up to Rack ID 400) For all methods, all the sample cups must have a requisition, or the default (#0) will be performed. Orange Rack: Use this rack for Manual repeat-run analysis. If the system has the optional Auto Repeat Unit, repeats can be performed automatically in the white racks. Place sample cups in the orange rack in the order of the repeat-run sample numbers for sequential analysis. Samples with an ID can be placed in any order in the orange rack for repeat analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 23

33 Warning Use the appropriate sample cup for the rack being used. If the wrong sample cup is used, analysis may not be performed. Use sample cups that meet the following conditions in the Flex rack. Outer Diameter: Inner Diameter Length 11.5 to 16.0 mm 9.0 to 15.0 mm 55.0 to mm Note Even if the conditions listed above are met, the Venoject-II type sample cup cannot be used. The caps of adjacent sample cups will interfere with each other. To insert sample cups in Flex racks with barcode labels, use cups up to 16.0 mm in diameter maximum. Barcode label Top view Sample cup mm or less (outer diameter including the barcode label) Flex rack Barcode label Rack top 24 Rev 2, 07/06/07 AU5400 Quick Response Guide

34 Instruction If a sample is centrifuged in a primary tube to be analyzed on the AU5400 system, ensure that the serum is adequately separated from the red blood cells and does not contain clots or fibrin, and that the amount is sufficient for sample detection and analysis. The dead volume required for sample detection varies depending on the cup type. If the serum height in the sample cup is less than the limit, transfer the serum into a smaller sample cup, then start analysis. Otherwise, if the blood cells under the serum in the cup are aspirated, analysis and dispense abnormalities could occur. AU5400 Quick Response Guide Rev. 2, 07/06/07 25

35 Warning In sequential analysis, set sample cups on the white rack in sample number order without leaving any empty positions. If any position is different between the sample numbers set by the requisition operation and sample positions on the white rack, concordance errors will occur. The following example shows tests that were requisitioned for 15 samples: 4114 : Sample present Correct Placement Requisitioned sample numbers Order of sample numbers in the rack : No Sample present Requisitioned tests A B C D E F G H I J K L M N O White rack Incorrect Placement Sample numbers shift Requisitioned sample numbers Order of sample numbers in the rack Requisitioned tests A B C D E G H I J K L M N O White rack ALARM : no cup Analysis test F for sample No.6 is not executed. ALARM: no-op An analysis test is generated automatically. If the analysis mode between racks changes, the sample numbers determined automatically according to a setting position on the rack will differ. : Sample present : No sample present Sample numbers determined automatically Moves to analysis mode 2 White rack Sample numbers determined automatically No change in mode White rack 26 Rev 2, 07/06/07 AU5400 Quick Response Guide

36 Flex Racks Applying Barcode Labels to the Sample Cups Place the barcode labels onto the sample cups so that they meet the following conditions: Do not allow the barcode to protrude from the top of a sample cup Apply the barcode label at least 7 mm above the bottom of the sample cup. If the label is applied below this position, the sample cup may not be completely inserted because the label can get caught on the edge of the hole on the rack. Apply a barcode label with an angle of 5 degrees or less. Make sure the entire surface of the label adheres to the cup. Do not apply a sealant, etc., or mark the sample cup below the barcode label. Do not insert foreign matter into the sample cup between the lower edge of the label and the bottom. Any of the conditions above could cause the sample cup sensor to fail. If the conditions listed above cannot be met due to special requirements, please contact Beckman Coulter Technical Services. Flex Rack The inclination angle must be 5º or less. Sample Cup Barcode Label Flex Rack Up to 7mm AU5400 Quick Response Guide Rev. 2, 07/06/07 27

37 Setting Sample Cups into the Rack Place the sample cups into the rack so that they meet the conditions shown in the figure below: The inclination angle must be 5º or less. Sample Cup The rack ID label is applied to this surface. Barcode Label The barcode label is applied to this surface. Flex Rack Up to 7mm Direction that rack moves Be sure to use the correct rack color. When using sample cups with a barcode label, position the barcode surface within +2 mm to the center of the side slit of each hole on the rack. Instruction Do not rotate the sample cups set in the rack to change their direction. The barcode may be contaminated or scratched resulting in a barcode read error. Remove the sample cup from the rack, and then rotate the cup in the correct direction before reinserting it into the hole. 28 Rev 2, 07/06/07 AU5400 Quick Response Guide

38 Placing Racks on the Analyzer Order for Placing the Racks The racks should be placed on the system according to rack type (color) and the function to be performed. Follow the order shown below: Place the sample cup containing deionized water in position one for all serum tests. Place cups in order of small test calibrator number to the largest number. Place cups beginning with the smallest control number. Place in sequential order. Direction that racks move. Place the sample cup containing deionized water in position ten for all urine tests. Blue Yellow Green White White Red Placing Racks on the Analyzer 1. Open the cover for the samples on the rack feeder as shown in the diagram below. AU5400 Quick Response Guide Rev. 2, 07/06/07 29

39 OLU2007 Surface where the rack ID label is applied Rack Sample protection cover Window for reading rack ID FRONT Rack supply unit Rack load inhibition LED Top view of rack feeder a Surface where the rack ID label is applied Window for reading rack ID a A maximum of 30 racks can be placed at one time. F R O N T Tips Do not place racks in position a as shown in the drawing. Problems with analysis could occur. 2. Set the racks on the rack feeder so that they are oriented as shown in the figure. When setting the racks pay attention to the rack and sample order, and the rack direction. Make sure that the racks are set so the surface on which the rack ID label is facing away from you. Blue Rack If reagent blank or calibration is required, place the blue rack on the feeder first. Yellow Rack If calibration is required, place yellow racks sequentially after the blue rack. Green Rack Run QC before routine analysis. 30 Rev 2, 07/06/07 AU5400 Quick Response Guide

40 White Rack For sequential analysis, place the racks in sample number order. The order for setting the racks is arbitrary for rack ID analysis and sample ID analysis. Red Rack: If emergency samples are to be processed, they can be run anytime during routine analysis by inserting red racks ahead of white racks. Tips A maximum of 30 racks can be set at one time. AU5400 Quick Response Guide Rev. 2, 07/06/07 31

41 Changing Reagents There are two methods for changing reagents: a method for setting individual reagent bottles, and a method for loading the reagent tray with reagent bottles already in place. Prepare the Reagent If necessary, prepare the bottles for the reagent corresponding to the type of analysis. There are six kinds of reagent bottles used in this system: 15 ml reagent bottle 30 ml reagent bottle 60 ml reagent bottle 120 ml reagent bottle 180 ml reagent bottle 300 ml reagent bottle Beckman Coulter reagents have a reagent ID. Bottles can also be used without a reagent ID. Load Reagent Bottles The R1 and R2 reagent compartments on each unit hold a maximum of 48 bottles for 60, 30, and 15-mL bottle sizes. The 120-mL bottle occupies 2 positions, the 180- ml bottle occupies 3 positions, and the 300-mL bottle occupies 5 positions in the reagent tray. Warning If you use 15 or 30 ml bottles, be sure to use the correct partitions. All bottle sizes require the proper separator in the reagent compartment. 1. Open the analyzer cover. 2. Lift up on the reagent refrigerator cover and remove it. Tips Condensation may appear in the reagent refrigerator under high-temperature and high-humidity environments. Remove the condensation by wiping the reagent refrigerator with a dry cloth. 32 Rev 2, 07/06/07 AU5400 Quick Response Guide

42 3. Set the individual reagent bottles in the compartment by gently pressing down on the front and back of the bottle. Replace old bottles with new ones if the reagent level is low, or if the reagent stability or expiration date has expired. Note The pre-dilution position is also checked. Pour fresh DI water in the bottle every day. Place it back into position by pressing it down. Warning It is imperative that the AU5400 reagent bottles are placed correctly in the refrigerator. If the end of a bottle is up, reagent probe crashes could occur. Warning Reagent bottles without barcodes: Place them in the reagent positions that have been fixed in [Reagent Status]. Reagent bottles with barcodes: Once the Reagent ID code is set in [Parameters], the reagents can be placed in any position. Bottles with barcodes should not be placed in fixed positions set in [Reagent Status]. When setting 15 ml or 30 ml reagent bottles, use a partition to secure the bottle. 4. Replace the reagent refrigerator cover to its original position. When installing the reagent refrigerator cover, make sure that the positioning pins on the reagent refrigerator are inserted in the holes in the reagent refrigerator cover. If the cover is not installed in the correct position, reagent will not be dispensed properly and probe damage could occur. 5. Select the [System Status], [Reagent Status]. 6. Select F5: Check Start. The reagent check start window is displayed. 7. Select Check for all positions. The amount of remaining reagent is automatically checked. After the reagent has been checked, the reagent check status is displayed as CHECKED in blue. 8. Select F2: Exit twice, to return to the main screen. AU5400 Quick Response Guide Rev. 2, 07/06/07 33

43 Note After performing a reagent volume check, if a reagent bottle(s) is missing Reagent of Group will appear in yellow. To view a summary of Unset R1 and R2 reagents, select F4: Reagent Setting. Place a new reagent bottle(s) into position and perform another reagent volume check. Reagent Check Options: The system defaults to perform a reagent check on all units. After selecting F5: Check Start, remove the check mark at a unit to check only the specified unit(s). RESET ONLY: Resets the status from Unchecked to Checked. Volume check or reagent read ID is not performed. CHECK SPECIFIED POSITION: Volume check one or more specific R1 and/or R2 positions. Reagent ID s are not read. Use for fixed positions. CHECK SPECIFIED POSITIONS (WITH ID): Reads reagent ID and volume checks one or more specific R1 and/or R2 positions. CHECK CHANGED POSITION (WITH ID): Reads all positions for reagent ID. Volume checks any new or moved reagents. CHECK ALL POSITIONS: Reads all positions for reagents ID and volume checks all reagents. With ID Read is gray (not operational) when reagent status is Unchecked all positions are read for reagent ID. With ID Read is white (operational) when the status is Checked. The check can be removed to volume check all reagents without reagent ID reading. 34 Rev 2, 07/06/07 AU5400 Quick Response Guide

44 How to Fix a Reagent Position Reagents that are not barcoded or have a damaged barcode must be assigned (fixed) in reagent positions. If a reagent is not barcoded, the operator must put the reagent in the correct position. This procedure can also temporarily correct for reagent ID read errors that are generated during the reagent volume check. Both components of the R1/R2 pair must either be assigned as reagent ID or fixed. 1. Select [System Status], [Reagent Status]. 2. At Unit No, select the unit to fix the reagent. 3. Select the R1 or R2 bottle position to fix the reagent. 4. Select F6: Edit. 5. At Test, select the test to fix. 6. Select Fixed Reagent with the option button. 7. Enter the Lot No. 8. At Bottle Size select the correct bottle size of 15, 30, 60, 120, 180 or 300 ml. The default size is 60ml. The bottle size is used in the reagent volume check calculations. 9. Select the CLOSE button. 10. Perform a volume check on the fixed reagent using the Check Specified Position option. Note Blue highlights on this screen indicate the reagents are checked and the status is good. If yellow highlights appear on a bottle position, select F7: Test Display, Detail button and review the comments. For more information on each comment, refer to Reviewing Reagent Position Errors located in [System Status], [Reagent Status] of the Software Chapter in the AU5400 User s Guide AU5400 Quick Response Guide Rev. 2, 07/06/07 35

45 Adding Wash Solution If there is insufficient concentrated wash solution in Detergent Tank B, analysis pauses, and a warning message is displayed on the screen. Check the amount of wash solution in Detergent Tank B. If needed, add wash solution and press start to resume analysis. Warning When removing the cap on the wash solution tank, be careful not to get any of the wash solution on your hands. If your hands or clothing come into contact with the wash solution, immediately wash it off with water. Also, if any wash solution gets in your eyes or mouth, rinse it out immediately and consult a physician. See Also For information on adding wash solution, refer to the Maintenance Chapter located in the AU5400 User s Guide. 36 Rev 2, 07/06/07 AU5400 Quick Response Guide

46 How to Place the Sample Pre-dilution Bottle Samples will automatically be diluted with deionized water retrieved from the pre-dilution bottle when the bottle is placed on the analyzer and the parameters are set. 1. Prepare a 120 ml reagent bottle for each unit to be used as the predilution bottle. 2. Fill the sample pre-dilution bottles with deionized water. See the Maintenance Chapter for proper cleaning procedures. 3. Set the bottle in the pre-dilution position by the R1 compartment on each unit. Place the bottle in the compartment so it does not protrude above the surface of the analyzer top. If it is not placed properly reagent probe crashes could occur. Also, do not place the cap on the bottle when it is on the analyzer, this also causes probe crashes. Sample pre-dilution bottle FRONT Pre-dilution bottle position 77 AU5400 Quick Response Guide Rev. 2, 07/06/07 37

47 38 Rev 2, 07/06/07 AU5400 Quick Response Guide

48 Starting Analysis This section describes the necessary procedures for starting analysis. Analysis should be started from the Standby mode. Starting Analysis After preparing for analysis, perform the following procedure. See Also For information, refer to the section called Preparing for Analysis. 1. From the main menu, select [Routine] and [Start Conditions] in that order. The start conditions are displayed. 2. Check the settings for the data index, round number, and operator name. Also check the start number for serum, urine, and other samples. 3. Verify that calibration status is Selected if performing reagent blanks or calibrations. If it is not selected, refer to Performing Calibrations and a Reagent Blank located in the Preparing for Analysis section of this chapter. 4. Press F2: Exit. The main screen is displayed. 5. Press the START key. The window for starting analysis is displayed. Tips To change a setting such as the Start Routine S. No., press F4: Set. 6. Check the start routine and urine S. No., operator name, and error list. If a fatal error (red) occurs, it is not possible to start analysis on that unit. No tests are processed on a unit with a fatal error. It is possible to start analysis with nonfatal (yellow) errors. A message describing the error is displayed. Check the description of the error and press Yes to bypass the error and start analysis or press No to perform corrective actions before analysis. Follow the necessary corrective actions to recover from the error. See Also For information on recovering from errors, refer to the Troubleshooting Chapter located in the AU5400 User s Guide. AU5400 Quick Response Guide Rev. 2, 07/06/07 39

49 Tip An alarm will occur if: 1. A different reagent lot number is used from those used for reagent blank or calibration. 2. If different reagent lot numbers are mixed for the same analysis item. If a new lot number is detected, perform a reagent blank or calibration on that test. The same reagent lot number should be used for reagent blank, calibration and patient samples. If these problems are not corrected, accurate analysis results cannot be obtained. 7. After performing the above check, select Yes and press Enter. The analysis operation starts. After STANDBY MEAS. 1 is displayed on the upper left of the screen, MEAS. 1 is displayed. After starting analysis, the first result is calculated. Results print as they are completed for the sample. 40 Rev 2, 07/06/07 AU5400 Quick Response Guide

50 Obtaining Results After the control sample is analyzed, check the QC data printout for error flags. If the QC falls out of a preset QC range, an alarm will be generated. To verify QC, there are three kinds of QC charts: daily variation chart, dayto-day variation chart and the twin plot chart. The quality control charts are checked using [Daily Control] and [Day to Day control] screens. Contents Checking Results Checking Quality Control Checking the Daily Variation Chart...43 Checking the Day-to-Day Variation Chart...44 Performing a Repeat Run How to Print a Repeat Run Work List...45 How to Modify the Repeat Work List:...46 How to Perform an Auto-Repeat Run...47 How to Perform a Manual Repeat Run...47 Reporting Repeat Results or Original Results...48 How to Reprint Reagent Blank, Calibrator, QC and Patient Data AU5400 Quick Response Guide Rev. 2, 07/06/07 41

51 Checking Results After analysis for one sample finishes, the results are immediately saved on the hard disk and a list of results are printed. Checking Results 1. Look at the printout and check it for error flags. If error flags appear on the printout, perform the corrective action corresponding to that flag. 2. Perform corrective actions for any alarms generated during the run. See Also For information about error flags, refer to the Error Flags Chapter located in the AU5400 User s Guide. For alarm information, select the Alarm Help icon, or [System Status], [Alarm List]. 42 Rev 2, 07/06/07 AU5400 Quick Response Guide

52 Checking Quality Control After the control sample has been analyzed, check the QC data printout for error flags. If the QC falls outside a preset QC range, an alarm will be generated. To verify QC, there are three kinds of QC charts: daily variation, day-to-day variation, and twin plot. The quality control charts are checked using [Daily Control] and [Day To Day Control] Checking the Daily Variation Chart Before viewing charts, look up QC alarms using the on-line help function and check the QC samples listed on the printout for error flags. If an alarm or error flag occurs, correct the problem. QC samples must be run with no flags or alarms before routine samples are valid. See Also For information about errors flags, refer to the Error Flags Chapter located in the AU5400 User s Guide. 1. From the main menu, select [Routine], [QC Monitor] and [Daily Control]. The screen for selecting the control sample for quality control is displayed. 2. At Index, set the index for the time period to view. Note The index, sample type, and control name can be selected by using the pulldown menu located by each box on the screen. 3. At Control Name, select the control(s) to view. 4. Select the test(s) to be referenced 5. Press F6: Daily Data. The chart with daily variation data is displayed. 6. Check the chart for abnormal data. See Also For information about handling errors, refer to the Troubleshooting Chapter located in the AU5400 User s Guide. 7. Use F5: Previous Control Test and F6: Next Control Test to look at other QC test charts. AU5400 Quick Response Guide Rev. 2, 07/06/07 43

53 8. Select F3: Print to print statistics, data, graphs, or comments. 9. Optional Step: Select F4: Comment if you want to enter a comment. 10. After checking the chart, press F2: Exit. The main screen returns. Checking the Day-to-Day Variation Chart 1. From the main menu select [Routine], [QC Monitor] and [Day To Day Control]. The screen for selecting the control sample for quality control is displayed. Note The index, sample type, and control name can be selected by using the pull-down menu located by each box on the screen. 2. At Index, set the starting and ending index for the time period to view. Press F8: Control No.. Enter the control number of the control sample to be referenced and choose OK. 3. At Control Name, select the control(s) to view 4. Press F6: Day to Day. The chart of day-to-day variation data is displayed. 5. Check the chart for abnormal data. See Also For information about handling errors, refer to the Troubleshooting Chapter located in the AU5400 User s Guide. 6. Use F5: Previous Control Test and F6: Next Control Test to look at other QC test charts. 7. Select F3: Print to print statistics, data, graphs, or comments. 8. Optional Step: Select F4: Comment if you want to enter a comment. 9. After checking the chart, press F2: Exit. The main screen returns. 44 Rev 2, 07/06/07 AU5400 Quick Response Guide

54 Performing a Repeat Run Perform a repeat run based on laboratory protocol for repeat analysis. There are two ways to perform a repeat run: automatically, and manually using the orange racks. Repeat parameters including test specific repeat ranges, sample volume, and abnormal flags can be programmed to automatically place a sample into the repeat data file. If Auto Repeat is set in [Parameters], [System], [System] the repeat run will be performed automatically according to the information in the repeatrun data file. Note The AU5400 must have the optional auto repeat unit in order to perform auto repeat analysis. If Standard Repeat is set in [Parameters], [System], [System], print the contents of the repeat-run data file in a work list. Perform a repeat run manually according to the contents of that file using the orange racks. How to Print a Repeat Run Work List To obtain a list of samples that generated repeat run requisitions, print a repeat run worklist. These samples can then be analyzed as manual repeats in the orange racks. Printing and Checking the Repeat Run Work List: 1. From the main menu, select [Routine], [Test Requisition] and [Repeat]. The screen for performing the requisition operation for repeat run analysis is displayed. 2. Press F3: Print. The window for printing the work list displays. 3. Enter a check by the Sample Type to print. 4. Enter the range of sample numbers or Sample ID numbers to print, or leave the *.* to print the entire range of available samples. 5. If it is necessary to change the list number, use the pull-down menu located by the Repeat Work List field on screen. 6. Select the OK button twice. The repeat run work list begins printing. AU5400 Quick Response Guide Rev. 2, 07/06/07 45

55 7. Check the contents of the repeat run work list. 8. Use the worklist to perform a manual repeat in the orange rack or modify the worklist before performing repeat analysis. How to Modify the Repeat Work List: To Delete a Sample from the Repeat Requisition: 1. Select [Routine], [Test Requisition], [Repeat]. 2. Select F6: Delete Sample. 3. Enter a check by the sample type to delete. 4. Enter the Sample No.(s) or Sample ID (s) to delete. 5. Select the Delete button. 6. Select the Renum button to re-number the repeat sample numbers sequentially. To Change a Repeat Requisition: 1. Select [Routine], [Test Requisition], [Repeat]. 2. Select F4: Start Entry. 3. Select the test to add (blue) or to delete (gray). 4. Select F6: Change Dil to change between Normal (dark blue), Dilute (light blue), or Condense (green) sample volume. 5. Select F4: Entry to perform the repeat in an orange rack. To Add a Sample to the Repeat Requisition: 1. Select [Routine], [Test Requisition], [Repeat]. 2. Use the arrow buttons at S. No. or F8: S. No. to get to the original sample number. 3. Select F4: Start Entry. 4. Select the test to add (blue) or to delete (gray). 5. Select F6: Change Dil to change between Normal (dark blue), Dilute (light blue), or Condense (green) sample volume. 6. Select F4:Entry to perform the repeat in an orange rack. 46 Rev 2, 07/06/07 AU5400 Quick Response Guide

56 How to Perform an Auto-Repeat Run Note The AU5400 must have the optional Auto Repeat unit to perform auto repeat analysis. When a test generates a specified flag, it is automatically requisitioned for repeat analysis. The white routine rack or red emergency rack is fed back to the rack buffer belt, and the entire rack goes back on the bypass belt for repeat analysis. Only the tests which generated a repeat requisition will be performed. Dilutions are performed automatically. 1. Press START. Routine and emergency samples run and repeat automatically based on programmed repeat run criteria. 2. Repeat samples will have an H prefix on the data printout. For example, routine samples will print as H0001 and routine urine samples will print as HU001. See Also For information on how to print a repeat-run worklist and modify the worklist, refer to that procedure located in this section. For information about starting analysis, refer to the Starting Analysis section. For information on repeat results, refer to Reporting Repeat Results or Original Results in this section. How to Perform a Manual Repeat Run Repeat requisitions are made automatically according to pre-programmed criteria. Dilutions are made automatically during the repeat run according to repeat criteria. 1. After performing a routine run, print a repeat run work list. Modify the work list if necessary, and print a new repeat run work list. 2. Pick up the repeat run samples according to the repeat run work list and load them into the orange racks. If Sequential mode is in use, samples must be sequential in the repeat sample number order in the orange racks. If Sample ID is in use, samples can go in any order in the orange racks. Place samples in the orange rack according to the designated sample type. AU5400 Quick Response Guide Rev. 2, 07/06/07 47

57 3. Press START. Repeat samples will have an H prefix on the data printout. For example, routine samples will print as H0001 and routine urine samples will print as HU001. See Also For additional information on repeat runs, refer to the beginning of the section called Obtaining Results. Reporting Repeat Results or Original Results Repeat results can be programmed to overwrite original results automatically, or the operator can select whether to use the original result or the repeat result. An S flag will be attached to data that is repeated and the original result is overwritten with the repeat result. The S flag will display on reprinted data from the AU5400, or data that is batch transferred to a host computer. There is a checkbox in [Parameters] that affect final results: [Parameters], [Repeat Parameters], [Repeat Common], Repeat Data Overwrite : If Yes is selected the overwrite option is on. If Yes is not selected the automatic overwrite option is off. How to Manually Overwrite Original Results with Repeat Results: Note Do not check Repeat Data Overwrite in [Parameters], [Repeat Parameters], [Repeat Common]. 1. Select [Routine], [Data Management], [Repeat Data Verification]. 2. At Index select an index to overwrite data. 3. At Test Name select All or a specific test to overwrite. 4. Check the Sample Type to overwrite. 5. Enter the Repeat Sample No.(s) or leave the * to overwrite all repeat sample numbers. 6. Select F5: Rewrite to view the original data and repeat data. 7. Select the test(s) to overwrite (the test highlights in blue). 8. Select F5: Execute Rewrite. 48 Rev 2, 07/06/07 AU5400 Quick Response Guide

58 9. The S flag indicates the sample was repeated, and the repeat result overwrites the original result. AU5400 Quick Response Guide Rev. 2, 07/06/07 49

59 How to Reprint Reagent Blank, Calibrator, QC and Patient Data Reprinting Data The analyzer is in a Standby Mode: 1. From the main menu select [Routine], [Data Report], and [Data List]. 2. Select the Patient tab or QC/Cal tab located at the top of the screen. 3. Specify the index and type of the sample to be printed. 4. Enter the Sample No. or Sample ID range to print, or leave the * to print the entire range displayed. 5. Select F3: Print. Start Printing? Select OK. 6. After the data is printed, select F2: Exit. The analyzer is in a Measure Mode: If a printer error occurs during a measure mode: The data that did not print will be stored in the printer buffer. Note The analyzer will not start while any print jobs are in process. If the analyzer shifts to Standby and data is not printed, the alarm Not All Data Output Yet appears when the Start key/icon is selected. 1. Select [System Status], [DPR Status]. 2. Select F4: Printer Control. This only displays when a problem occurs and there is data to print. 3. Correct the printer error. 4. A window appears to select Resume Printing or Cancel Print. All data will print if Resume Printing is selected. 50 Rev 2, 07/06/07 AU5400 Quick Response Guide

60 Finishing Analysis After all of the samples have been analyzed, perform an End Process. Even though analysis is finished, it does not mean that the power to the system is turned off completely. The reagent refrigerators and incubators require power to be maintained. The ISE unit also requires power to perform an automatic, periodic priming cycle. Ending ISE Analysis 1. Perform Daily ISE Maintenance: Fill an ISE cup with ISE cleaning solution, and place it on the Clean position on the ISE standard solution area. Select [System Status], [ISE Status], F5: ISE Unit Start. Select E. Cleaning. The ISE is cleaned automatically for about 4 minutes. 2. Return to the main menu. Select the End process key. See Also For detailed information about performing ISE Maintenance, refer to the Maintenance Chapter located in the AU5400 User s Guide. AU5400 Quick Response Guide Rev. 2, 07/06/07 51

61 Ending Analyzer Analysis The following procedure can be performed during a W2. The power to the system is automatically turned off after the W2 is complete. Perform an End Process: 1. Select F2:Exit to return to the main screen. 2. Select the End Process key on the keyboard. Options: Set an automatic on time. One day of the week set an automatic on time with photocal Automatic on times and automatic on with photocal are programmed for each day of the week in [Parameters], [Auto Power On]. Press the Set (S) button. At Auto On select the Yes radial button. Enter the Date and Time for the analyzer to turn on. Once a week at with Auto Preparation select the Yes radial button to perform a photocal. Select the End (E) button. 3. At Power Off? select the Yes button. 52 Rev 2, 07/06/07 AU5400 Quick Response Guide

62 As-Needed Tasks This section contains information about tasks that are performed on an asneeded basis. The following information is included: Contents Checking Analysis Conditions Maintenance and Inspection Move a Reagent to Another Unit: Processing Emergency Samples Pausing Analysis Stopping the Rack Feed Unit Creating a New Profile Changing QC Ranges Changing Calibrator Set Points Turning on/off the Sample ID Barcode Reader Programming the Auto Power On Creating a User Menu Standby Mode Programming a New Test How to Save or Load Parameters to a Floppy Disk AU5400 Quick Response Guide Rev. 2, 07/06/07 53

63 Checking Analysis Conditions While analysis is in progress, it is possible to check the status of the following: Reagent Status, ISE Status, Data Display, Alarm List, Cuvette Status, Analyzer Status, and DPR Status (data and printer status). See Also For detailed information, refer to the [System Status] section located in the Software Chapter located in the AU5400 User s Guide. 1. Select the [System Status] icon. The [System Status] screen is displayed. 2. Select Reagent Status, ISE Status, Data Display, Alarm List, Cuvette Status, Analyzer Status, or DPR Status. Reagent Status View the reagent volume and shots (tests) remaining, reagent on-board stability, calibration stability, lot number, bottle number, bottle sequence, and any reagent comments. ISE Status When performing analysis using the ISE, it is possible to display the data and graph of the slope of the calibration curves for Na, K and Cl. Also, it is possible to display the MID-standard solution factor and selectivity check results. Data Display Displays the analysis results as they are completed. Data displays in red if an error flag is attached. Alarm List Displays an alarm list of previous alarms. Use this menu to determine recent or common alarms, then use corrective actions found in the on-line help function, F6: Display Help. Cuvette Status Use this menu to perform the required cuvette checks after a photocal is performed. It also displays a list of defective cuvettes and the date/time that the photocal measurement and W2 were executed. 54 Rev 2, 07/06/07 AU5400 Quick Response Guide

64 Analyzer Status Displays wash solution, ISE reagent status, tank solution level, temperature of refrigerator and incubator, and the sample number of the sample being analyzed. DPR Status Displays the sample number of the sample for which analysis has started and ended. Displays sample numbers that were input/output on-line between the system and host computer, and displays printer status. Use to resume printing if a printer error occurred during a measure mode. AU5400 Quick Response Guide Rev. 2, 07/06/07 55

65 Maintenance and Inspection The following list provides an overview of daily maintenance and inspection procedures. It is very important to perform maintenance on schedule so the analyzer runs efficiently. For detailed information on maintenance or inspection procedures, refer to the Maintenance Chapter located in the AU5400 User s Guide. The following procedures are based on 18,000 tests per day, on each unit. Analyzer Maintenance Daily Maintenance Inspect the sample and reagent syringes. Check the wash solution levels. Note The analyzer will pause if wash solution is empty. Inspect and clean the sample probes, reagent probes, and mix bars on each unit. Check the printer and printer paper. Prepare for a sample probe wash. Change the DI water in the pre-dilution bottles on each unit. Bi-Weekly Maintenance Perform a W1. Weekly Maintenance Perform a W2 (automatic wash of the probes, mix bars and cuvettes). Perform a photocal (after the weekly W2). Perform a photometer check (after the photocal). Wash the sample pre-dilution bottle. Clean all wash wells Clean air filters Clean the sample probes and mix bars. Clean belts and rack transport areas. Monthly Maintenance Clean the wash nozzles. Clean the deionized water tank Replace the deionized water filter Replace the sample probe filter. Maintenance Required Every Six Months Clean the Cuvettes and the Cuvette Wheel. 56 Rev 2, 07/06/07 AU5400 Quick Response Guide

66 As Needed Maintenance Replace or clean individual cuvettes. Replace sample and reagent probes. Replace mix bars. Replace wash nozzle joint tubes. Replace sample and reagent syringes. Replace the photometer lamp. Perform a W1. ISE Maintenance Daily Inspect the ISE syringes for leaks. ISE Cleaning (short). Check the ISE sample probe dispense. Check the sample probe detergent. Clean the mix bars, liquid level sensors, sample pot and sample pot tubing. Weekly ISE Cleaning (Enhanced). Perform a selectivity check of the ISE Na/K electrodes. Monthly Replace the mixture and mid-standard pump roller tubing. Replace the valve tubing. As Needed Replace the reference electrode. Add reference electrode solution. Replace reagents. Replace the Na, K, and Cl electrodes. Replace the ISE syringes. ISE cleaning procedure See Also For detailed information on performing Maintenance, refer to the Maintenance Chapter located in the AU5400 User s Guide, Volume II. AU5400 Quick Response Guide Rev. 2, 07/06/07 57

67 Move a Reagent to Another Unit: Move reagents to a new unit if one unit is down. Move a reagent to a new unit for troubleshooting. Verify calibrator positions by selecting [Routine], [Test Requisition], [Calibration], F6: Cal. A calibrator may need to go in a different rack if multi-rack ID is in use. Caution Moving reagents to new units can affect sample throughput! 1. Select [Parameters], [Common Test Parameters], [Round]. 2. At Round Name select Round 1, 2, or At Unit No., select the new unit number for the reagents to be moved. 4. Select F4: Set. 5. Select F5: Edit. 6. Highlight the tests to move to the new unit. 7. Select the Close button. 8. At Unit No., select the current unit number for the reagents to be moved. 9. Select the tests to remove the highlight. 10. Select the Close button. 11. Select F2: Exit. Verify the reagents are on the correct unit. 12. Select F2: Exit. 13. Select [System Status], [Reagent Status]. 14. Move the reagent bottles to the new unit. Fixed reagents must be fixed on the new unit. Refer to the Fix a Reagent Position procedure in the Preparing for Analysis section of this guide. If the reagent is being moved to a new unit permanently, un-fix the reagent positions on the old unit. 15. Perform a new reagent volume check on the units to update reagent status. 58 Rev 2, 07/06/07 AU5400 Quick Response Guide

68 Processing Emergency Samples Emergency samples can be processed prior to the routine samples by inserting red racks in front of the white racks on the rack feeder belt. Red racks (emergency) are processed on the bypass belt for faster movement to the sample aspiration position on each unit. Using the Red Rack The procedure for requisitioning emergency samples using the red rack is the same as that for normal analysis except they are requisitioned as E samples. An E will appear on the printout before the sample number indicating the emergency sample and data. Tips Use the REV./DIAG button to reverse the rack feeder belt and load red racks in front of any white routine racks. Red racks are processed on the bypass belt for faster transport to the sample aspiration position on each unit. Processing an Emergency Sample Using the Red Rack First, display the screen for performing normal analysis requisition. 1. On the main screen, select [Routine], [Test Requisition], and [Normal]. The screen for requisitioning normal analysis is displayed. 2. From the S. No. prompt, type E, then press ENTER. The next available emergency sample number will display. 3. Select the sample type (serum, urine, or other). 4. Press F4: Start Entry. 5. Enter sample ID, sex, age and profile if required. 6. Select the tests to be performed on the sample. 7. Press F4: Entry. The next sample number is available for requisition. 8. Repeat the previous steps for all emergency samples. 9. Set the sample cups containing the emergency sample(s) into the red rack. AU5400 Quick Response Guide Rev. 2, 07/06/07 59

69 See Also For information about how to place samples and racks, refer to Preparing Samples and Racks. 10. Select the REV./DIAG button to reverse the rack feeder belt. Load red racks in front of any white routine racks on the rack feeder belt. 11. Press START to begin or resume analysis. See Also For information on how to start analysis, refer to Starting Analysis. 60 Rev 2, 07/06/07 AU5400 Quick Response Guide

70 Pausing Analysis Pausing the system stops analysis after completing the current test. When analysis is started again, the system begins with the next test after the pause was executed. Use the pause function for such things as replenishing reagent. After pausing analysis, the current test(s) can be continued and completed. Warning If analysis is paused, do not leave the system in this state for any length of time. If the system is left in pause for a long time, there is a possibility that some samples could become concentrated inside the sample cup, which could affect the data. Pausing Analysis Warning When analysis is paused, the rack in which a sample was being analyzed should not be removed. If it is removed, when the pause is released, the sample number and actual sample cup will not correspond. Analysis will then be incorrect. 1. Press the PAUSE key or pause icon ( ) during the analysis operation. The window for executing the pause is displayed. 2. Select YES and press ENTER. A message indicating that a pause is being executed is displayed. Analysis will continue for the test currently being analyzed, and the analysis operation will pause at the position of the sample that was being analyzed. It takes approximately 14 minutes to Pause, then a reagent volume check can be performed. Caution In Pause, reagents can be loaded and a reagent volume check performed to update the new reagent volume. Only the Reset and Check Specified Position options are available, perform the Check Specified Positions on the new reagent(s). The reagent check is only available before the Reagent short alarm occurs. AU5400 Quick Response Guide Rev. 2, 07/06/07 61

71 Releasing the Pause 1. With the analysis operation in the pause, press the START key. The window for releasing the pause is displayed. 2. Select YES and press ENTER. Analysis begins from the test after the one that was being analyzed when the pause occurred. 62 Rev 2, 07/06/07 AU5400 Quick Response Guide

72 Stopping the Rack Feed Unit Stopping the rack feed unit stops racks from being fed into the analyzer. When analysis is started again, the system begins feeding the rack that was at the start of the rack feeder when it was stopped. Use the stop rack feed function for such things as inserting an emergency rack (red rack) for analysis. Stopping the rack feeder 1. Press the FEEDER STOP key/icon (> ) during the analysis operation. The window for stopping the feeder is displayed. 2. Select Yes and press ENTER A message indicating that the rack feeder is being stopped is displayed. The analysis operation continues for racks that have already been fed from the feeder, and stops at the rack at the start of the rack feeder. Starting analysis after the rack feeder was stopped 1. With the rack feeder stopped, perform the requisition operation in the same way as was done for normal analysis. See Also For information about how to perform the requisition operation for normal analysis, refer to Starting Normal Analysis. 2. Press the START key/icon to resume feeding the rack on the feeder belt. Analysis begins with the first rack in the rack feeder. See Also For information on how to start analysis, refer to Starting Analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 63

73 Creating a New Profile Individual tests are assigned for each profile. Profile number 0 is defined as the default profile. The default profile is automatically used in 2 situations: 1. Barcode read error in barcode analysis. 2. No requisition for a sample in the sequential analysis mode. 1. Select [Parameters], [Common Test Parameters], [Profile]. 2. Select F4: Set. 3. Select F8: Profile No. and enter a profile number to make a new profile. 4. Enter the profile name at the Profile Name field, then select OK. 5. From the Test No. field, select F5: Edit and select the tests required for the profile. Select CLOSE to set the profile. 6. Verify the tests selected appear on the screen with the correct profile number. 7. Select F2: Exit to set the profile information. 8. Optional: Select F3: Print for a list of the profile no., name, and tests selected in that profile. 9. Select F2: Exit again to return to the main menu. 64 Rev 2, 07/06/07 AU5400 Quick Response Guide

74 Changing QC Ranges QC ranges can be set and changed when operating in the Preset Mode. The QC Mode is set in the [QC Common] screen to preset, cumulative, or none. 1. Select [Parameters], [QC Control], [QC Specific]. 2. Use F8: Test No. to get to a specific test number, or use the pull-down menu located next to the test name field. 3. Press F4: Set then F5: Edit. At Control Name select the QC material. At Multi/Single select single or multi rules. Refer to the QC programming information in [QC Common] in the User s Guide. Enter the new QC average (mean), standard deviation (SD), and range at the prompts. The mean is listed on the package insert. The range (2SD above and 2SD below the mean) is listed on the package insert. Type in the entire value of the range. The SD (1SD) is the range divided by Select the CLOSE button and select F2: Exit to set the new ranges. 5. Optional: Select F3: Print to print a list of the new mean, SD, and range. Example: The Control package insert lists the mean as 120, and the range as 115 to 125. You would type in 120 as the mean, 10 as the range and 2.5 as the SD. AU5400 Quick Response Guide Rev. 2, 07/06/07 65

75 Changing Calibrator Set Points 1. Select [Parameters], [Calibration], [Calibration Specific]. 2. At Test Name, select a specific test. 3. Select F4: Set. Enter the new calibrator concentration at the CONC prompt from the package insert. 4. Select F2: Exit to set the new concentration. 66 Rev 2, 07/06/07 AU5400 Quick Response Guide

76 Turning on/off the Sample ID Barcode Reader The sample ID reader can be turned on or off for routine and emergency racks. 1. Select [Parameters], [System], [System]. 2. Select F4: Set. From the Test Requisition field, select the pull-down menu next to the routine, and emergency racks. 3. Select Sequential to turn off the barcode reader or select Barcode to turn on the barcode reader. AU5400 Quick Response Guide Rev. 2, 07/06/07 67

77 Programming the Auto Power On 1. Select [Parameters], [System], [Auto Power On]. 2. Select F4: Set, then enter the day and time (based on a 24 hour clock) you want the analyzer to turn on. Select Auto Preparation by the day of the week to perform the weekly photocal. On this day the analyzer turns on, the lamp warms up for 20 minutes, then the photocal is performed. 3. Select F2: Exit. 4. When the END PROCESS key is selected, the next On time and photocal will be displayed. If you want to change the next On time, or Photocal time, select the SET button. 68 Rev 2, 07/06/07 AU5400 Quick Response Guide

78 Creating a User Menu This menu contains customized menu options. A maximum of 16 frequently used menus can be added in the [User] menu from any of the following menus: [Routine], [Parameters], [Auxiliary], and [Maintenance]. 1. Select [Parameters], [System], [User Menu]. 2. Select a blank line number. Select F5: Entry. The User Menu set-up screen will display. Select the first menu to be part of the User Menu. Select OK. The screen selected appears as part of the User Menu list on the left side of the screen. 3. To change the name of the menu to a user-defined name, select F6: Change. Type in a maximum of 30 characters for the new menu name 4. Select the next menu position in the User Menu. 5. Repeat steps 2 and 3 until all the screens you want to add are part of the User Menu. If necessary, select F7: Delete to delete a menu. Press F2: Exit. 6. When [User Menu] is selected from the Main Menu, a pull down menu of the choices selected will appear. AU5400 Quick Response Guide Rev. 2, 07/06/07 69

79 Standby Mode Use [Standby Set] menu to shift the analyzer to Standby from Warm-up. If the system is in a Stop mode, shift to Standby using the Stop key or icon (yellow square) located at the top of the screen. If analysis is performed after shifting to Standby from Warm Up, results could be compromised since the system temperature did not have time to stabilize completely. Standby from Warm Up Mode Note The system requires a 20-minute Warm Up to stabilize the lamp temperature after turning ON the analyzer. After an Emergency Stop is performed by pressing the Orange button, the system stays in Warm Up for one and a half hours. Use the [Standby Set] menu to bypass the Warm Up after 20 minutes. 1. Select [Auxiliary], [Standby Set]. 70 Rev 2, 07/06/07 AU5400 Quick Response Guide

80 Programming a New Test The following procedure explains how to define a new test. For detailed information on each software screen refer to the Software Chapter located in the AU5400 User s Guide. Assign Test Name and Reagent ID and Alarm Shot Volume: 1. Select [Parameters], [Common Test Parameters], [Test Name]. There are 6 tabs on screen to choose from: Test Name, Long Name, Reagent ID, Calculated Tests, Multi-Reagent Switch and Alarm Shot. 2. In the Test Name tab, select F4: Set:. Select an available test number (1-95, Numbers are set). Enter the abbreviated test name, 1-5 characters. Note Do not change the test name without noting the time and date the change occurred. If the test name is changed it will affect all test results retrospectively with that test number. Consequently, any previously reported results (with the old name) will be assigned the new test name. Use extreme caution when making any changes to the test name and all recorded changes. 3. Select the Reagent ID tab. F4: Set:. Select the new test(s), and select F5: Edit. At Test Code, enter the first 3 digits of the reagent ID, or refer to the Methodology sheet for the reagent ID 3 digit code. Select the CLOSE button. 4. Select the Multi-Reagent Switch Tab: Select (highlight in blue) the new test(s). This causes the analyzer to switch to a new set of R1/R2 when either of the R1 or R2 becomes empty. 5. Select the Use Cuvette Tab: Select the new test number, F5 Edit. Assign the test to run on the inner or outer cuvette wheel by selecting Inner or Outer. Note The throughput of the analyzer is affected by the test assignment to the inner or outer cuvette wheel. To maximize throughput, verify an equal number of tests AU5400 Quick Response Guide Rev. 8, 07/

81 are assigned to the inner and outer wheels on each unit. It is not recommended to assign a test to Both sides of the wheel. 6. Select the Alarm Shot Tab: Note Select the new test(s) and select F5: Edit. At Alarm, enter the shots to generate a reagent short alarm. The default is 32. Select the CLOSE button. Reagent Short alarms and comments in yellow in [Reagent Status] appear when the volume in the bottle is equivalent to the alarm shot programmed. The alarm shot volume is calculated as the Change/Dead Volume + [Reagent Dispense Volume + Dummy Dispense]* Alarm Shot Value. The largest reagent dispense volume of Serum, Urine, or Other triggers the reagent short alarms and comments in [Reagent Status], even when urine or other sample type is not in use ( Operation No. ). Example with a 30-mL bottle: Alarm shot (Vol) = 1000 ul + [180+5]* 32 = ml Add the Test to the Round: 1. Select [Parameters], [Common Test Parameters], [Round] 2. At Round, select Round 1, 2, or 3 for the new test. A Round is the group of on-board tests that can be run at one time. 3. At Unit No., select the unit to run the test. 4. Select F4: Set, F5 Edit 5. Select (highlight) in blue the test(s) to add to the Round and Unit. Note The order in which the tests are assigned in F6: Sequence determines the order tests print on the data log printout. 6. Select the CLOSE button. 7. Select F2: Exit to verify parameters, then F2: Exit to return to the Main Menu. Enter Specific Test Parameters: 1. Select [Parameters], [Specific Test Parameters]. 72 Rev 2, 07/06/07 AU5400 Quick Response Guide

82 2. At Test Name, select the required test. 3. At Type, select Serum, Urine, or Other. 4. Select F4: Set.. 5. At Operation, select Yes for the required sample type to run on the test. Verify No. is selected for sample types not in use for the test. 6. Refer to the appropriate Methodology Sheet in the AU5400 User s Guide Volume 2, Methods Chapter to enter specific test parameters in the General Tab. 7. Select the Range Tab: Set a generic reference range ( 7. None Selected ) to generate H and L flags on samples when the range is exceeded. Select F7: Decimal Places to set the appropriate decimal place for results. Optional: At Panic Value, set a panic range for samples to generate an alarm and p flags when the range is exceeded. 8. Select F2: Exit to verify parameters, then F2: Exit to return to Main Menu. Program New QC Material 1. Determine if it is necessary to program new QC material. Select [Parameters], [QC Control], [QC Common]. 2. Select the Control Tab: Up to 60 Different QC materials can be programmed for serum, urine, and other types. 3. If it is necessary to add new QC material, Select F4: Set. Select an available QC Number ( No ) with the appropriate sample type. The QC number is the position the control is placed in the green rack. Select F5: Edit. Enter the Control Name, Control ID (if using barcoded QC samples), Expiration, and Lot No.. Select the Close button. Select F2: Exit to verify information, then F2: Exit to return to the Main Menu. Program QC Ranges: 1. Select [Parameters], [QC Control], [QC Specific] (Preset Tab). 2. At Test Name select the required test. AU5400 Quick Response Guide Rev. 2, 07/06/07 73

83 3. At Type, select the required sample type. 4. Select F4: Set, F5: Edit. At Control Name select the appropriate QC material At Multi/Single, select single, or multi rules for evaluating QC data. Refer to the AU5400 User s Guide, Software Tab for more information on Single or Multi rules. At Mean, enter the QC mean. At SD, enter a one standard deviation value. One SD is the difference of the Range, divided by 4. Example The range on the QC package insert is Enter 2.5 for SD (35-25 = 10, 10/4 = 2.5). At Range, enter the difference of the range for acceptable QC. Use the arrow button to move to the next QC material. Select the Close button 5. Select F2: Exit to verify the information, then F2: Exit to return to the main menu. Program New Calibrator Material: 1. Determine if it is necessary to program new calibrator material. Select [Parameters], [Calibration], [Calibrator]. 2. If it is necessary to add new calibrator material, select F4: Set. Up to 200 different calibrator materials can be programmed for serum, urine, and other types. Select an available calibrator number ( No. ) with the appropriate sample type. The Calibrator number is the position the calibrator is placed in the yellow rack. Select F5: Edit. Enter the Calibrator Name, Calibrator ID (if using barcoded calibrator samples), Expiration and Lot No.. Select the CLOSE button. 3. Select F2: Exit to verify information, then F2: Exit to return to the Main Menu. Program Calibrator Set Points 1. Select [Parameters], [Calibration], [Calibration Specific], (General Tab). 74 Rev 2, 07/06/07 AU5400 Quick Response Guide

84 2. At Test Name, select the required test. At Type, select the required sample type. 3. Select F4: Set. 4. Refer to the Methodology Sheet in the AU5400 User s Guide Volume 2, Methods Chapter to determine if the Calibration Type is AB or MB, and enter Calibration Specific parameters. 5. If the Calibration Type is AB : Formula : Refer to the methodology sheet. Counts (replicates) enter 1-4. Generally, Beckman Coulter recommends programming 2 replicates. Process : enter CONC or OD. Refer to the AU5400 User s Guide for more information. Cal. No. : enter the calibrator number assigned to the appropriate calibrator material from the [Calibrator] menu. CONC : enter the calibrator set point from the package insert. Factor/OD-L and Factor/OD-H : refer to the methodology sheet. Advanced Calibration : enter Lot or Lot + Bottle. Calibration Stability Period : refer to the methodology sheet. 6. If the Calibration Type is MB Formula : Refer to the methodology sheet. Counts (replicates) enter 1-4. Generally, Beckman Coulter recommends programming 2 replicates. Process : enter CONC. or OD Refer to the AU5400 User s Guide for more information. Advanced Calibration enter LOT or Lot + Bottle. MB Type Factor : Each analyzer has a unique, preset MB factor for the inner and outer wheel, and each unit. Beckman Coulter personnel enter all MB factors at installation, save MB factors to the account s parameter disk, and maintain records by analyzer serial number. 7. Select F2: Exit to verify information, then F2: Exit to return to the Main Menu. Program the Tests on Formatted Lists: 1. Add the test(s) to any formatted lists in use (worklist, pending list, data list, or repeat list). 2, Select [Parameters], [Format], [List Format]. AU5400 Quick Response Guide Rev. 2, 07/06/07 75

85 3. At List Name, select the required list. 4. Select F4 Set, Test Tab. 5. Select (highlighted in blue) the test(s) to add to the list. 6. Select F2: Exit to verify the information, then F2: Exit to return to the Main Menu. Run the Tests to Verify Programming: 1. Load the reagents to the appropriate unit. 2. Perform a reagent volume check on the new reagents. 3. Verify that calibration and QC is requisitioned for the new tests. 4. Place the reagent blank, calibration, and QC racks on the rack feeder unit and start the analyzer. 5. Review the printout and verify that all reagent blank, calibration and QC is within range. 76 Rev 2, 07/06/07 AU5400 Quick Response Guide

86 How to Save or Load Parameters to a Floppy Disk Caution Floppy disks increase the potential of harmful viruses infecting the analyzer s computer. To avoid damage to the computer and the data, before loading or saving data to a floppy disk, always perform a virus check on the floppy disk using any commercially available virus protection software, to ensure the disk is free from harmful viruses. Prepare an initialized floppy disk Important: AU5421 and AU5431 floppy disks must be used with the specific analyzer configuration from which they were made, AU5421 or AU5431. The floppy disks are not interchangeable between analyzer configuration. Note Initialize a 3.5 floppy disk as a parameters disk one time before parameters are saved or loaded. The floppy disk can be 2HD or 2DD. Select [Maintenance], [Data Operation], [FD Data Management], FD Data Initialize Tab. Select the Initialize Parameter FD option. Insert the floppy disk in the computer. Select F5: Start Initialize. From the Insert FD Start prompt, select yes. The message Operating: Wait for a while displays. 1. From the main menu select [Auxiliary], [Parameters Management]. 2. Depending on your requirements, select either Save Files to FD or Load Files from FD. The save files to FD option will save files on the computer hard drive to the floppy disk. The load files from FD option will load files from the floppy disk onto the computer hard drive. Loading files onto the computer hard drive writes over the existing files with the same name. Important When saving files to a floppy disk, files can be saved to the hard drive by selecting the option called Save files to HD. This keeps the hard drive current in case the Load files from HD option is accidentally selected. 3. Select one or more of the files in the File column. AU5400 Quick Response Guide Rev. 9, 11/

87 4. Insert the floppy disk in the computer. Select F5: Execute. From the Insert FD Start prompt, select YES. The message Operating: Wait for a while displays. 78 Rev 9, 11/2009 AU5400 Quick Response Guide

88 Troubleshooting This section contains common troubleshooting procedures. For more detailed troubleshooting information, refer to the Troubleshooting Chapter in your AU5400 User s Guide. For more information about error flags, non fatal and fatal errors, refer to the Error Flags Chapter in your AU5400 User s Guide. The following information is included: Contents Data Error Flags Non Fatal Errors (Yellow) Fatal Errors (Red) Performing a Stop or an Emergency Stop During Analysis Performing a Stop Function...86 Resetting the System After a Stop...86 Performing an Emergency Stop...87 Recovering from an Emergency Stop or Power Loss Recovering from a Cuvette Wheel Overflow What causes an overflow...90 Recognizing a overflow...91 Recovering from a overflow...92 After the overflow problem is fixed...92 AU5400 Quick Response Guide Rev. 2, 07/06/07 79

89 Data Error Flags i d e The following information briefly explains the error flags that can occur on your printout. For detailed information on causes and corrective actions, refer to the Error Flags Chapter located in the AU5400 User s Guide. Manual dilution not calculated for ISE tests Flags QC data that was excluded from calculation. Edited Data ( Shortage of wash solution for contamination parameters in user defined wash solution bottle R1 & R2 R Reagent is empty # Sample Level Detection Error % Clot detected? Unable to perform calculations U u Y Reagent blank absorbance at last photometric point is low Reagent blank/routine absorbance at first photometric point is low Reagent blank absorbance at last photometric point is high Reagent blank/routine absorbance at first photometric point is high Test results are too high $ Not enough data to determine linearity of reaction D B Absorbance of reaction is greater than maximum OD range Absorbance of reaction is less than minimum OD range * Linearity error in rate methods & Z Prozone test data is abnormal Prozone error! Data calculation is impossible ) Cannot convert from OD to CONC a b F G p T P N Expired reagent or onboard stability expired Calibration expired Results higher than the dynamic range Results lower than the dynamic range Out of the panic value range Abnormality found in inter-chemistry check Positive: Any value above flag level H Negative: Any value below flag level L 80 Rev 2, 07/06/07 AU5400 Quick Response Guide

90 H Result higher than normal value range L Result lower than normal value range J Result is higher than repeat run range K Result is lower than repeat run range x Data not registered 1 Data exceeds QC range 2 Data exceeds the 3SD control limit 3 Data continuously exceeds the 2SD control limit 4 Data exceeds R 4S control limit 5 Data exceeds 4 1S control range 6 Data over/under last 10 averages 7 Data over/under range S Sample repeated and original results replaced with repeat results / Test requisition entered, but not performed r Data transmitted to the host computer c Corrected Data AU5400 Quick Response Guide Rev. 2, 07/06/07 81

91 Non Fatal Errors (Yellow) Non fatal errors can occur during start-up. The following section gives more information on these errors and how to correct them. Non fatal means the operator can choose to start analysis anyway. See Also For start-up procedures, refer to Starting Analysis. Cal data incomplete Cal. error test exist Cal. expired Calibration: No select (Rack) Cuvette temperature Cuvette check is not performed Error cuvette Expired Incorrect Reagent Set ISE buff shortage For advanced calibration tests, a calibration curve is not available for the bottles to be used during analysis, or the most recent calibration curve is not available for the round. A new test was added to the system and a calibration was not performed or failed the calibration. Check the test located in [Routine], [Calibration Monitor], [Calibration Curve] screen. Refer to Troubleshooting for Data Flags located in the Error Flags Chapter in your AU5400 User s Guide for procedures on verifying calibrator material. Calibration frequency has expired. Check the calibration stability date in [System Status], [Reagent Status]. Requisition for the expired tests in the [Routine], [Test Requisition], [Calibration] screen. Run the reagent blank and calibrate the expired tests. No tests are requisitioned for calibration in [Routine], [Tests Requisition], [Calibration]. If calibration is required, requisition for calibration before starting analysis. If calibration is not required start analysis. Temperature has exceeded standards. Call Beckman Coulter Technical Services. A Photocal was performed, but the cuvette check process was not done. Select System Status, Cuvette Status, F5: Check Start. Select Cuvette to check the inner and outer cuvette wheel. Select Unit No. to select unit 1, 2, and/or 3. Select F5: Check Start for each side of the wheel, and all units. A cuvette may be dirty or scratched. Check the error in [System Status], [Cuvette Status]. Refer to the AU5400 User s Guide, Maintenance Chapter to clean or replace individual cuvettes. Repeat the Photocal until all cuvettes pass without errors. Reagent stability has expired. Select [System Status], [Reagent Status]. Select F7: Test Display, Detail button and check for the expired reagents. Replace any expired reagents and perform a reagent volume and ID check to update the system. Check the error in [System Status], [Reagent Status]. This may mean: the calibration stability expired, the lot number is new, the reagent is empty, the on board stability expired, or the date on the reagent bottle expired. Insufficient buffer solution. 82 Rev 2, 07/06/07 AU5400 Quick Response Guide

92 ISE Detergent Unchecked ISE mid. shortage ISE no cal. ISE ref. shortage ISE select errors ISE slope errors ISE stop No Cal. Data No RB data Not Assigned Seq No. On board expired R1/R2 Pair Mismatch RB Data Incomplete RB error test exist Reagent lot no (cal) The ISE sample probe detergent check has not been performed ([System Status], [ISE Status], S-Detergent Tab, F5: Check Start) after an End Process was performed. Insufficient mid-standard solution. 1. The ISE was not calibrated for serum or urine. OR 2. An End Process was performed and ISE no cal occurs again when the instrument is on. You can start analysis and use the last calibration slopes obtained. Insufficient reference solution Refer to the Selectivity Check procedure in the ISE Maintenance section of the Maintenance Chapter located in the AU5400 User s Guide. Refer to the ISE Calibration Errors procedure in the Troubleshooting Chapter located in the AU5400 User s Guide. The ISE unit has stopped. Reset the ISE unit in [System Status], [ISE Status] Calibration data is not available for any of the bottles to be used during analysis, or the most recent calibration data is not available for the designated round. RB data is not available for any of the bottles to be used during analysis, or the most recent RB data is not available for the designated round. The bottle sequence number was not assigned after a reagent check. The bottle cannot be sequenced because there is a problem with the R1 or R2 of the test R1/R2 set. This error may also occur if lot numbers do not match, or R1/R2 are not both ID, fixed, short, empty, onboard expired. Reagent on-board stability has expired. Select [System Status], [Reagent Status] and check the on-board stability, if it has expired, replace the reagent. Perform a reagent volume check to update the information. One of the following problems may have occurred: The lot numbers for R1 and R2 do not match. Either R1 or R2 is missing, has an error, or there is no record stored in reagent history. Perform a reagent check to update the status after correcting the problem. A new bottle(s) was added, and a reagent blank was not performed. Requisition and run a reagent blank on the new bottle(s). Or the most recent RB data are not available for the designated round. A new test was added to the system and a reagent blank was not performed or failed. Check the test located in [Routine], [Calibration Monitor], [Reagent Blank Monitor] screen. Refer to Troubleshooting for Data Flags in the Error Flags Chapter located in the AU5400 User s Guide for procedures on verifying reagent integrity. A different reagent lot number from that used at calibration was placed on the analyzer. Calibrate the reagent. AU5400 Quick Response Guide Rev. 2, 07/06/07 83

93 Reagent lot no (RB) Reagent Temperature Unset Reagents A different reagent lot number from that used for the reagent blank was placed on the analyzer. Perform another reagent blank. Reagent refrigerator temperature is out of the standard range. Call Beckman Coulter Technical Services. A reagent assigned to the round in use (on-board) is missing from one of the units on the analyzer. Determine what reagent is missing. Use [Reagent Status], F4: Reagent Setting and compare with the reagents in the refrigerator for each unit. Perform a reagent volume check. 84 Rev 2, 07/06/07 AU5400 Quick Response Guide

94 Fatal Errors (Red) Fatal errors can occur during start-up. The following section gives more information on these errors and how to correct them. Fatal means analysis will not occur on one or more units with the fatal error until the problem on the unit(s) is corrected. Important Verify a fatal error does not exist on unit 1, 2, and/or 3 before starting analysis. The analyzer will start, but analysis will not occur on a unit with a fatal error. See Also For start-up procedures, refer to Preparing for Analysis and Starting Analysis. Diluted washer B short DI water shortage Incorrect Parameters ISE Busy ISE cover open Rack receiver full Reagent cover open Unchecked Reagent The solution in diluted wash solution tank B is low. The deionized water tank is low. A message appears on screen indicating the incorrect parameter. Open the screen containing the incorrect parameter, determine the parameter error and correct it. The parameters are saved automatically. The ISE unit is operating. After the ISE operation is complete start analysis. The ISE cover is open or it is not closed properly. The rack receiver unit is full. The R1 or R2 cover on one of the units is not on the R1 of R2 refrigerator. A reagent check was not performed or the [Parameter] menu was accessed. This will change the reagent status from checked to unchecked. Select the [System Status], [Reagent Status] screen and perform the appropriate reagent check option. Washer A shortage Replenish fluid in concentrated wash solution tank A. Washer B shortage Replenish fluid in concentrated wash solution tank B. Vacuum tank full Other Errors The vacuum tank is full. Wait until the analyzer empties the tank. If the problem persists, contact Beckman Coulter Technical Services. A specific error name and description displays. Clear the error and restart analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 85

95 Performing a Stop or an Emergency Stop During Analysis Performing a Stop Function A stop can be performed from most analyzer modes to stop analysis or maintenance procedures. This is not an emergency stop. In the event of a stop or an emergency stop, it is not possible to use the data that was not completed. Analysis must be repeated. 1. Press the STOP icon on the menu bar or press the STOP key on the keyboard during analysis. The window for executing a stop is displayed. 2. Select YES, then press ENTER. A message indicating that a stop is being executed is displayed. The entire analysis operation stops, the system switches to the stop mode within 4.5 seconds. Resetting the System After a Stop By pressing the STOP key again after the stop has been executed, it is possible to reset the system. 1. Remove any racks on the rack transfer belt. 2. After the stop is executed (stop mode), press the STOP key again. The window for starting the reset operation is displayed. 3. Select Yes and press ENTER. The system is reset. After the system has been reset, it switches to the Standby mode. 4. If in sequential analysis, reset the Start Number to the sample number after the last sample that was printed (completed analysis). See [Routine], [Start Condition] menu. Move the first sample requiring analysis to the first position in the rack to be analyzed. If empty spaces are left in the rack, no cup alarms are generated and requisitions will not be performed. This could lead to concordance errors. 5. Press START. 86 Rev 2, 07/06/07 AU5400 Quick Response Guide

96 Performing an Emergency Stop Note The analyzer will stay in a Warm Up mode for 1 1/2 hours after an EM Stop is performed. To bypass this mode, select [Auxiliary], [Standby Set]. Caution If the nature of the emergency compromises operator or instrument safety, press the orange EM Stop button immediately. Please be aware that pressing the orange EM Stop button without performing the other steps listed below could cause damage to the computer hard drive. Also, the operating system and application files could become corrupted. The following steps are the preferred method of shutting down the AU5400 during an emergency: 1. Press the following keys on the keyboard: CTRL + ALT + Delete. The Task Manager will appear. 2. From the Task Manager screen, select the SHUTDOWN button, on the second screen, select SHUTDOWN again. Windows Operating System will close all open files and databases. 3. When the message It is now safe to turn off your computer appears, press the orange EM Stop button on the front of the analyzer. All power to the system turns off. Important In the event of a stop, an emergency stop, or power loss, it is not possible to use the data. Analysis must be repeated. If analysis was in progress and a stop or an emergency stop was performed, reagent still remains in the cuvettes. This can cause damage or deterioration in the cuvettes, or may cause abnormal results. If reagent was in the cuvettes for a lengthy period of time, perform a W1 prior to restarting analysis. AU5400 Quick Response Guide Rev. 2, 07/06/07 87

97 Recovering from an Emergency Stop or Power Loss In the event of a power failure or an emergency stop, the main power is immediately turned off, and the power to the incubators and reagent refrigerators are also turned off. Resetting the System after a power failure or an Emergency Stop 1. Press the white Reset button on the front of the analyzer. 2. After 10 seconds, press the green On button. The software will load. Wait approximately 20 minutes until the photometer lamp has stabilized before starting analysis. A message displays for a few minutes Program download to analyzer. Then an alarm occurs Power Failure Detected. Clear the alarm by pressing the Alarm Clear button on the screen or keyboard. Press the White Reset button to reset the alarm. It is necessary to reset the alarm so that the alarm is generated only at the next Emergency Stop or power failure. Green ON button Red EM STOP button White RESET button FRONT 88 Rev 2, 07/06/07 AU5400 Quick Response Guide