Beckman Coulter IMMAGE 800 Operation Manual
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Beckman Coulter IMMAGE 800 Operation Manual

Beckman Coulter IMMAGE 800 Operation Manual

Immunochemistry system, for in vitro diagnostic use
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Table of Contents

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A11403AE
September 2016
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
Operations Manual
IMMAGE 800
Immunochemistry System
For In Vitro Diagnostic Use

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  • Page 1 Operations Manual IMMAGE 800 Immunochemistry System For In Vitro Diagnostic Use A11403AE September 2016 Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.
  • Page 2 CH -1260 Nyon 1, Switzerland Tel: +41 (0) 22 365 36 11 Beckman Coulter do Brasil Com e Imp de Prod de Lab Ltda Calçada Aldebarã, 39, Centro De Apoio 2 - Alphaville, Cep 06541-055 - Santana De Parnaíba, Sp, Brasil CNPJ: 42.160.812/0001-44...
  • Page 3 Software version 2.0 Changes: Copyright page • Revised EC REP address. Appendix A, Part Number List was deleted. • Refer to www.beckmancoulter.com or contact your Beckman Coulter representative. A11403AD, October 2011 Software version 2.0 IMMAGE 800 Operations Manual A11403 Revision History...
  • Page 4 Revision History IMMAGE 800 Operations Manual A11403 Page 2 of 2 September 2016...
  • Page 5 Operating Precautions and Hazards section. Safety During Installation and/or Maintenance This instrument is designed to be installed by a Beckman Coulter Field Service representative. Installation by anyone other than authorized Beckman Coulter personnel invalidates any warranty covering the instrument.
  • Page 6 It is always necessary to wash your hands thoroughly after performing any routine maintenance. Dispose of all waste solutions according to appropriate environmental health and safety guidelines. Safety Notice IMMAGE 800 Operations Manual A11403 Page 2 of 2 September 2016...
  • Page 7 Quality Control ....................9-1 CHAPTER 10 Utilities ......................10-1 CHAPTER 11 System Status/Instrument Commands ............11-1 APPENDIX A Instrument Codes .................... A-1 APPENDIX B Reports ......................B-1 GLOSSARY INDEX IMMAGE 800 Operations Manual A11403 Table of Contents September 2016 Page 1 of 2...
  • Page 8 Table of Contents IMMAGE 800 Operations Manual A11403 Page 2 of 2 September 2016...

  • Page 9: Table Of Contents

    Introduction ..........................1-2 How to Use This Manual ......................1-3 Warranty and Service Policy Information ................1-5 Precautions ..........................1-6 Hazards ............................ 1-7 Symbols and Labels ........................ 1-9 IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards September 2016 Page 1-1...

  • Page 10: General Information/Precautions And Hazards

    The system methodologies are rate turbidimetry and rate nephelometry. The IMMAGE 800 is a high throughput, random access analyzer that features bar code identification of samples and reagents to perform sample testing. It automatically dilutes the samples and delivers them to the reaction cuvette along with other reaction constituents.

  • Page 11: How To Use This Manual

    How to Use This Manual Scope of This Manual This manual provides information on the operation of the IMMAGE 800. Diagnostic interpretation or the clinical significance of the assay results provided by the system are not discussed in this manual. Typical and actual results are shown only to demonstrate the operating procedures, parameters, and characteristics of the system.
  • Page 12 To enter individual Sample IDs, type the Sample IDs for rerun in the Sample IDs field. To enter a range of Sample IDs, type the Sample ID at the beginning of the range in the Range field. General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1-4 September 2016...

  • Page 13: Warranty And Service Policy Information

    Service Information If any fault develops in the system, call the Beckman Coulter Clinical Support Center. Give full details of the difficulty. Be sure to have the model and serial number (located on the lower right side of the instrument near the front.)

  • Page 14: Precautions

    CAUTION Use extreme care when removing bar coded or labeled glass sample tubes from the IMMAGE 800 sample racks to avoid breakage. Rotating the tube slightly while pushing from the bottom of the tube may make removal easier. General Information/Precautions and Hazards...

  • Page 15: Hazards

    Three-pronged Power Plugs The three-pronged power plug from all system components of the IMMAGE 800 Immunochemistry System must be connected to a three-wire grounded power source. • Do not use an adapter to connect the power plug to a two-pronged outlet.
  • Page 16 Incineration of used reagent cartridges may produce toxic fumes. Handling of Hazardous Substances If a hazardous substance such as blood is spilled onto the IMMAGE 800 System, clean up the spill by using a 10% bleach solution, or use your laboratory decontamination solution.

  • Page 17: Symbols And Labels

    Introduction Symbols and Labels Introduction The following list of symbols and labels is used on the IMMAGE 800 Immunochemistry System. The symbols are affixed to the appropriate components of the system as described briefly below. Instrument or Uninterruptible Power Supply (UPS) Power Switch, ON This symbol is located on the instrument and the UPS main power switches.
  • Page 18 This symbol is located beside the connection between the computer and the keyboard. Computer - Keyboard Connection Connection Between Computer and Printer This text is located next to the connection between the computer and the printer. Parallel General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1-10 September 2016...
  • Page 19 This symbol cautions that the manual should be read before using the system. Read Manual General Biohazard Caution This symbol is the international symbol for biohazardous material. Biohazard Label IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards September 2016 Page 1-11...
  • Page 20 Reagent Compartment Cover Notice This label is located on the reagent compartment cover. The instrument will stop if the cover is opened. A010647L.EPS Reagent Compartment Cover Label General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1-12 September 2016...

  • Page 21: Immage 800 Operations Manual A11403 General Information/Precautions And Hazards September 2016 Page

    Symbols and Labels Laser Certification Label Laser Certification Label This label is located on the right side panel. Laser Certification Label IMMAGE 800 Operations Manual A11403 General Information/Precautions and Hazards September 2016 Page 1-13...
  • Page 22 Symbols and Labels Laser Certification Label General Information/Precautions and Hazards IMMAGE 800 Operations Manual A11403 Page 1-14 September 2016...

  • Page 23: Chapter 2 System Description

    Bar Code Label Specifications ....................2-53 Applying Bar Code Labels ....................2-55 Sample Volume ........................2-56 Loading Tubes Into Racks ....................2-57 Instrument Operation Overview ....................2-58 Instrument Operation ......................2-58 IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-1...

  • Page 24: Hardware Components

    Introduction The IMMAGE 800 Immunochemistry System is a bench-top analyzer composed of the IMMAGE 800 instrument, computer and printer. (Refer to Figure 2.1.) The system is shipped complete for installation. The system will be installed by a Beckman Coulter Representative.

  • Page 25: Instrument

    Instrument Description Instrument Description The IMMAGE 800 instrument is the analytical unit where the samples and reagents are loaded and where the chemical reactions take place. (Refer to Figure 2.2.) A011409P.EPS 1. Reagent Compartment 4. Sample Carousel 2. Reagent Crane 5.

  • Page 26: Reagent Compartment

    3. Reaction Buffer Bottle 7. Temperature Sensor 4. Reagent Cartridges (Compartments A and B) Figure 2.3 The Reagent Compartment NOTICE The instrument will stop if the reagent compartment cover is opened. System Description IMMAGE 800 Operations Manual A11403 Page 2-4 September 2016...
  • Page 27 Reagent Bar Code Reads bar codes on reagent cartridges. Reader Fans Circulate cool air in reagent compartment. Peltier Temperature Helps control 15°C in reagent compartment. Sensor IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-5...

  • Page 28: Reagent Crane

    The reagent crane transfers reagents and buffers from the reagent compartment to the reaction wheel. (Refer to Figure 2.4.) 1. Reagent Probe/Mixer 2. Reagent Syringe Pump 3. Reagent Crane Wash Station 4. Reagent Addition Ports Figure 2.4 Reagent Crane System Description IMMAGE 800 Operations Manual A11403 Page 2-6 September 2016...
  • Page 29 Washes interior and exterior of reagent probe/ Station mixer. Reagent Addition Two openings in reaction module cover to allow Ports reagents to be added to one of two different cuvette locations. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-7...

  • Page 30: Reaction Module

    Humidity" in this chapter.) 1. Optics 5. Cuvette Wash Station 2. Reaction Wheel 6. Heat Block Temperature Sensor 3. Cuvette 7. Status Monitor Temperature Sensor 4. Reference Cuvette Figure 2.5 Reaction Module System Description IMMAGE 800 Operations Manual A11403 Page 2-8 September 2016...
  • Page 31 Cuvette Wash Station Washes the cuvette after the reaction is complete. Heat Block Controls 37°C in reaction module. Temperature Sensor Status Monitor Monitors reaction module temperature. Temperature Sensor IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-9...

  • Page 32: Sample Carousel

    5. Sample Bar Code Reader 2. Sample Diluent Bottle 6. Sample Carousel Advance Button 3. Sample Rack 7. Background Bar Code Label 4. Dilution Segment Figure 2.6 Sample Carousel System Description IMMAGE 800 Operations Manual A11403 Page 2-10 September 2016...
  • Page 33 Informs instrument of presence or absence of Label sample tube. When the sample bar code reader can read the background bar code, no sample tube is present at that position. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-11...

  • Page 34: Sample Crane

    Reagent Crane. (Refer to Figure 2.7.) 1. Sample Probe/Mixer 2. Sample Syringe Pump 3. Sample Crane Wash Station 4. Sample Addition Ports Figure 2.7 Sample Crane System Description IMMAGE 800 Operations Manual A11403 Page 2-12 September 2016...
  • Page 35 Washes interior and exterior of sample probe/ Station mixer. Sample Addition Two openings in reaction module cover to allow Ports samples to be added to one of two different cuvette locations. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-13...

  • Page 36: Upper Instrument Subsystems

    Pressure and vacuum control this fluid motion. (Refer to Figure 2.8.) 1. Pressure Reservoir-Liquid 2. Pressure Reservoir-Air 3. Vacuum Reservoir Figure 2.8 Hydro Pneumatics System Description IMMAGE 800 Operations Manual A11403 Page 2-14 September 2016...
  • Page 37 Upper Instrument Subsystems Electronics Compartment Electronics Compartment The electronics compartment contains the electronic circuit boards. (Refer to Figure 2.9.) Electronic circuit boards should only be handled by a Beckman Coulter service representative. 1. Circuit Boards Figure 2.9 Electronics Compartment IMMAGE 800 Operations Manual A11403...
  • Page 38 Power Supply Assembly Power Supply Assembly All of the power supplies used by the IMMAGE 800 instrument are contained in this area of the instrument. (Refer to Figure 2.10.) Power supply assemblies should only be handled by a Beckman Coulter service representative.

  • Page 39: Wash Solution Box And Waste Container

    Orange: vents wash solution to box. Waste Container Holds waste. (A drain can be used instead.) Waste Tubing (green) Outlet for waste leading to waste container or drain. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-17...
  • Page 40 The wash solution box must be close enough to the instrument to allow connection of the wash solution tubing. Waste Container Placement The waste container must be placed with the opening of the waste container no higher than the top of the instrument. System Description IMMAGE 800 Operations Manual A11403 Page 2-18 September 2016...

  • Page 41: Racks

    • 13 × 100 mm • 13 × 75 mm Applying Rack Labels Refer to CHAPTER 5, System Setup, Instrument Setup, Placing Labels on a Rack for a detailed procedure for label placement. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-19...
  • Page 42 Open the cover of the sample carousel. Align rack pegs over holes in the sample carousel. Lower rack pegs into carousel holes. Figure 2.13 Loading Rack onto the Sample Carousel System Description IMMAGE 800 Operations Manual A11403 Page 2-20 September 2016...

  • Page 43: Computer

    Additionally, patient results, control results, and setup parameters are stored on the computer. NOTICE Only the computer supplied by Beckman Coulter is to be used with the IMMAGE 800 Immunochemistry System. Changing the Date on the PC The PC supplied with some IMMAGE 800 systems contains a battery that provides power to the computer’s internal clock during power off.
  • Page 44 Uninterruptible Power The backup power source providing temporary Source (UPS) power to the computer for a limited period of time in the event of brownouts or low line voltage conditions. System Description IMMAGE 800 Operations Manual A11403 Page 2-22 September 2016...
  • Page 45 Computer Keyboard Keyboard Figure 2.14 depicts the 101- key enhanced keyboard used on the IMMAGE 800. 1. Escape Key 8. Backspace Key 2. Function Keys 9. Enter Key 3. Tab Key 10. Delete Key 4. Caps Lock Key 11. Page Up Key 5.
  • Page 46 Compact disks (CD-ROMs) require special care in handling. • Store away from direct sunlight, excessive heat, and humidity. • Hold the CD-ROM by the edges. • Replace the CD-ROM in its case after use. System Description IMMAGE 800 Operations Manual A11403 Page 2-24 September 2016...

  • Page 47: Printer

    Printer Description The printer supplied with the IMMAGE 800 Immunochemistry System is the HP DeskJet printer. The printer is designed to use single sheet paper. The printer is set up to use 8.5 × 11 inch paper. Paper size can be chosen in Printer Setup.

  • Page 48: Software Overview

    Overview Introduction The IMMAGE 800 is controlled through a graphical user interface (GUI). This section describes the basic functions within the interface. The concepts presented in this section should be understood by the user before attempting to use the IMMAGE 800.

  • Page 49: Screen Format

    Introduction The IMMAGE 800 Immunochemistry System is designed to have a user friendly interface. Figure 2.17 shows the sample programming screen of the IMMAGE 800 as an example of this interface. This screen is broken into six functional areas: • Status Bar •...
  • Page 50 The first line displays instructions and the second line displays error messages. These messages are related to activities in the working area. (Refer to Figure 2.18.) System Description IMMAGE 800 Operations Manual A11403 Page 2-28 September 2016...
  • Page 51 • Toggle buttons • Check boxes E010270S.EPS 1. Text Field 4. Toggle Button 2. Cursor 5. Check Box 3. Options Button Figure 2.18 Working Area of Program Sample Screen IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-29...

  • Page 52: Text Fields

    A message will display which reads "Only numeric characters are allowed." NOTICE The alphanumeric characters "|" (piping bar), "\" (backslash), " ^" (caret), and "&" (ampersand) are not allowed because they are host interface delimiters. System Description IMMAGE 800 Operations Manual A11403 Page 2-30 September 2016...

  • Page 53: Buttons

    The icons in the menu bar and the function buttons on the bottom of the screen operate like buttons. Example The options button <▼> next to the Sample Comment field on the Program Sample screen is an example of a button. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-31...

  • Page 54: Toggle Buttons

    Toggle buttons may either be in the selected or unselected state. If a toggle button is selected it will be highlighted in blue. Example Each chemistry button in the list of chemistries on the Program Sample screen is an example of a toggle button. System Description IMMAGE 800 Operations Manual A11403 Page 2-32 September 2016...

  • Page 55: Check Boxes

    A check box is either checked or unchecked. When checked, a check mark will appear in the check box. Example The STAT check box on the Sample Program screen is an example of a check box. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-33...

  • Page 56: Performing Software Functions

    Using Keyboard Equivalents All actions on the IMMAGE 800 can be performed with keyboard equivalents as well. The screen navigation will be affected by the location of the cursor on the screen. The...
  • Page 57 When the touch screen is used, the screen can be touched with a finger or any other object. Any button on the screen can be selected by touching the button on the screen. Any text field can be chosen by touching the field on the screen. IMMAGE 800 Operations Manual A11403 System Description September 2016...

  • Page 58: Selecting Vs. Choosing

    Selecting/Choosing by Mouse or Touch screen Buttons, toggle buttons, and check boxes are selected with the user’s first action and the [Spacebar] is not needed when using the mouse or touch screen. System Description IMMAGE 800 Operations Manual A11403 Page 2-36 September 2016...

  • Page 59: Dialog Boxes

    • the data is entered into the system or the action is performed • the dialog box closes This button can also be selected by pressing [Alt + o]. <Print> or <Display> Some dialog boxes may contain <Print> or <Display> buttons. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-37...

  • Page 60: Deleting Data From A Text Field And Printing Data From A Screen

    Printing Data from a Screen Many screens contain data that may be printed by selecting Print [F10]. Printing a Screen Any screen can be printed by pressing [Ctrl] + [P] simultaneously. System Description IMMAGE 800 Operations Manual A11403 Page 2-38 September 2016...

  • Page 61: Page Up/Page Down

    Keyboard Equivalents The keyboard equivalent of the screen Page Up and Page Down buttons are the [Page Up] and [Page Down] keys, respectively. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-39...

  • Page 62: Program Structure

    The icons in the menu bar at the top of the screen represent the various functional areas. The following menu tree displays an overview to the structure of the IMMAGE 800 software divided into its functional groups.
  • Page 63 (Calibration Options) Slope/Offset Adjustment Print Last Calibration Results Cal LdList [F6] (Calibration Loadlist) Cancel Request [F7] Read Cards [F8] E011370L.EPS Figure 2.21 IMMAGE 800 Program Tree (2 of 5) IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-41...
  • Page 64 QC Summary [F6] Print Inter-Lab [F9] Print [F10] QC Chart [F7] Control Chems [F1] QC File # [F2] Print [F10] Figure 2.22 IMMAGE 800 Program Tree (3 of 5) System Description IMMAGE 800 Operations Manual A11403 Page 2-42 September 2016...
  • Page 65 Restore Default [F1] Default Setup Sample Comments Demographics Setup Restore Default [F1] Printer Setup Languages/Keyboard Chemistry Protocol Diskette Instrument Serial Number Figure 2.23 IMMAGE 800 Program Tree (4 of 5) IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-43...
  • Page 66 Wash Cuvettes Fill Internal Wash Bottle Stop Print Reload DAS Code Calibrate Touch Screen Shutdown Status Dilution Segments Sample Carousel Status Figure 2.24 IMMAGE 800 Program Tree (5 of 5) System Description IMMAGE 800 Operations Manual A11403 Page 2-44 September 2016...

  • Page 67: Sample Programming Overview

    Sample Programming Overview Introduction Sample Programming Overview Introduction This section summarizes the sample programming methods for the IMMAGE 800 Immunochemistry System. Sample Programming Options The following table will summarize the sample programming options based on the variables of bar coded samples and host interface. For detailed explanations of sample programming refer to CHAPTER 7, Sample Programming, of this manual.

  • Page 68: System Specifications And Characteristics

    8.0 Amps (normal) 12 Amps surge Supplemental Specifications Environment Indoor use only Installation Category Pollution Degree EN55011 Meets class A Maximum Sound Pressure per IEC 61010-1 Normal: 82 dBA 1 meter: 71 dBA System Description IMMAGE 800 Operations Manual A11403 Page 2-46 September 2016...
  • Page 69 Waste Container Placement: The opening should be no higher than the top of the instrument. Regulatory Agency Approvals The IMMAGE 800 meets the safety requirements for the following agencies: CE, UL, CSA, IEC and CENFLEC. Environmental Conditions System can operate up to 8000 ft. (2,438m) elevation.
  • Page 70 Instrument Specifications Capacities Table 2.9 System Capacities , continued Item Capacity Wash solution 1 box/10 L/approximately 1,000 tests. Waste container 5 gallons (18.9 L). System Description IMMAGE 800 Operations Manual A11403 Page 2-48 September 2016...

  • Page 71: Peripheral Devices Specifications

    Peripheral Devices Specifications Introduction Peripheral Devices Specifications Introduction Refer to the inserts which accompany the respective peripheral devices (computer, printer, etc.) for product specifications. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-49...

  • Page 72: Sample Container Information

    Sample Container Information Sample Containers Allowed Introduction The following categories document specifications for sample containers that can run on the IMMAGE 800 Immunochemistry System. Primary Tubes 16 × 100 mm (10 mL) 16 × 75 mm (7 mL) 13 × 100 mm (7 mL) 13 ×...

  • Page 73: Bar Code Types And Options

    Code 128 Options The options for Code 128 bar codes are fixed in the software and cannot be reconfigured by the user. The IMMAGE 800 uses Code 128 formatting to read BECKMAN COULTER bar coded cards and rack ID. Fixed Code Length: disabled.
  • Page 74 Code Length may be enabled to ensure that only one length of sample ID is accepted. Define Code Length: When Fixed Code Length is enabled, the code length may be defined as from 1 to 15 characters. System Description IMMAGE 800 Operations Manual A11403 Page 2-52 September 2016...

  • Page 75: Bar Code Label Specifications

    Interleaved 2 of 5 Codabar Code 128 Check Characters The use of check digits and fixed length codes is highly recommended where possible. This greatly reduces the possibility of scanning errors. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-53...
  • Page 76 Label Sources Label Sources All patient and control sample labels are supplied by the customer. Preprinted labels can be used, or labels generated by a bar code printer. Beckman Coulter, Inc. recommends the following printers: Execuport 2400 Computer Transceiver Systems P.O.

  • Page 77: Applying Bar Code Labels

    Applying Bar Code Labels Correct Application of Bar Codes Applying Bar Code Labels Correct Application of Bar Codes Refer to the IMMAGE Sampling Template for the correct application of bar codes. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-55...

  • Page 78: Sample Volume

    Minimum Volumes Refer to the IMMAGE Sampling Template for minimum volume requirements. Primary Tube Sampling Template Before running a primary tube on the IMMAGE 800, verify sample tube volume level with the IMMAGE Sampling Template. System Description IMMAGE 800 Operations Manual A11403...

  • Page 79: Loading Tubes Into Racks

    The bar code must be visible to the Sample Bar Code Reader, otherwise the sample will not be identified or run. Example 1. Rack Bar Code Label Figure 2.25 Bar Coded Tube Orientation IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-57...

  • Page 80: Instrument Operation Overview

    Sample or diluted sample is added to the reaction cuvette with mixing. Reagent is then dispensed with mixing. The reaction is monitored from 90 seconds up to 5 minutes depending on the chemistry. (1 of 2) System Description IMMAGE 800 Operations Manual A11403 Page 2-58 September 2016...
  • Page 81 A concentration test result is calculated based on the calibration factor, the rate, and any dilution factors used. Results may be scaled into alternative reporting units defined by the user. IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2-59...
  • Page 82 Instrument Operation Data Reduction System Description IMMAGE 800 Operations Manual A11403 Page 2-60 September 2016...

  • Page 83: Chapter 3 Theory Of Operations

    Theory of Operations ........................3-2 Principles of Methodologies ....................3-2 Signal Measurement and Reaction Dynamics ................ 3-3 Antigen Excess Testing ......................3-8 Out-of-range Testing ......................3-11 Calibration ..........................3-12 IMMAGE 800 Operations Manual A11403 Theory of Operations September 2016 Page 3-1...

  • Page 84: Theory Of Operations

    7. Laser light bounces into light trap 4. Beam splitter 8. Turbidimetric detector (0° angle to the 5. Reaction cuvette incident LED beam) Figure 3.1 IMMAGE 800 Rate Nephelometer and Rate Turbidimeter Basic Components Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3-2 September 2016...

  • Page 85: Signal Measurement And Reaction Dynamics

    The system monitors scatter signal from the antigen antibody reaction at 5 second time intervals. At the end of the reaction, the system mathematically calculates the rate of change of the scatter signal. IMMAGE 800 Operations Manual A11403 Theory of Operations September 2016...
  • Page 86 Dynamic Blanking Dynamic Blanking The IMMAGE 800 automatically performs a patented dynamic blanking algorithm for selected analytes when testing at low serum dilutions. The results are improved by elimination of the nonspecific light scatter produced by the polymer enhanced reaction buffer interacting with the serum.
  • Page 87 2. Y = Peak rate of scatter 3. A-H represent peak response values at varying antigen concentrations. The antibody is maintained at a constant level. Figure 3.4 Protein Rate Response Curve IMMAGE 800 Operations Manual A11403 Theory of Operations September 2016 Page 3-5...
  • Page 88 (drug). A011359L.EPS 1. Conjugate-antibody complexing 4. Antibody 2. Inhibition of complexing by hapten 5. Hapten 3. Conjugate Antibody Figure 3.5 Inhibition of Immunoprecipitin by Hapten (drug) Theory of Operations IMMAGE 800 Operations Manual A11403 Page 3-6 September 2016...
  • Page 89 2. Y = Peak rate of scatter 3. A-E represent peak rate values at varying free hapten levels. Specific antibody and drug conjugate remain at constant levels. Figure 3.6 Drug Rate Response Curve IMMAGE 800 Operations Manual A11403 Theory of Operations September 2016 Page 3-7...

  • Page 90: Antigen Excess Testing

    Antigen Excess Testing Overview Antigen Excess Testing Overview Antigen excess (AGXS) testing is only necessary for some IMMAGE 800 protein reagents. Immunoglobulin G (serum IGG, urine IGU), Immunoglobulin A (IGA), Immunoglobulin M (IGM), Kappa (KAP), Lambda (LAM), Haptoglobin (HPT), Urine...
  • Page 91 (Refer to Figure 3.7.) A011361L.EPS 1. X = Increasing antigen concentration 3. Antibody excess (AbXS) 2. Y = Rate response 4. Antigen excess (AGXS) Figure 3.7 Antigen Excess Detection IMMAGE 800 Operations Manual A11403 Theory of Operations September 2016 Page 3-9...
  • Page 92 The system performs antigen excess testing by adding additional antigen to the completed reaction. Table 3.1 Antigen Excess Testing If unbound Ab is... the addition of more Ag will and the IMMAGE 800 will... result in... present an increase in rate response, as use the initial rate response to indicated by the solid line in calculate the final result.

  • Page 93: Out-Of-Range Testing

    Out-of-range Testing Description of Out-of-range Testing The IMMAGE 800 reagents have been optimized so that the initial measuring range will include the majority of the expected concentration values. Each reagent bar code card contains information which defines the out-of-range high and out-of-range low limits.

  • Page 94: Calibration

    Calibration Calibration Curve The calibration curve for each lot of reagent is determined by Beckman Coulter, Inc. In general, the calibration curve is formed from eight to twelve standards of known analyte concentrations, with approximately thirty points per standard, tested on multiple systems.

  • Page 95: Chapter 4 System Power On/Off

    CHAPTER 4 System Power On/Off Table of Contents System Power On/Off ......................... 4-2 System Power On ........................4-2 System Power Off ........................4-4 Database Recovery ........................4-5 Software Installation Instructions ................... 4-6 IMMAGE 800 Operations Manual A11403 System Power On/Off September 2016 Page 4-1...

  • Page 96: System Power On/Off

    System Power On Introduction System Power On/Off System Power On Introduction After the IMMAGE 800 Immunochemistry System installation, the system can be powered on. Power On Sequence Follow the steps below to power on the IMMAGE 800 system. Step Action Check that the floppy disk drive is empty.
  • Page 97 • Refer to CHAPTER 2, System Description, Computer, Printer, for the location of appropriate switches and connections. • Refer to the instruction manual provided with the UPS for specific information on the UPS. IMMAGE 800 Operations Manual A11403 System Power On/Off September 2016 Page 4-3...

  • Page 98: System Power Off

    Power Off Sequence The instrument status must be in Standby in order to proceed with the steps below to power off the IMMAGE 800 system. NOTICE The database may become corrupted if power is turned off before the Power Off sequence is completed.

  • Page 99: Database Recovery

    In the event of a fatal system error or power outage, the system will attempt to recover files and databases which may have been affected. Fatal Errors When a fatal error note is displayed, call Beckman Coulter for assistance. Information Retained The following information will be retained in the database after power is restored.

  • Page 100: Software Installation Instructions

    Loading System Software Software Installation Instructions Loading System Software The IMMAGE 800 System Software is preloaded on the hard disk. If re-installation of software is required, contact Beckman Coulter Clinical Support or a local Beckman Coulter Field Service office for assistance.

  • Page 101: Chapter 5 System Setup

    Programming a UDR Sample ..................... 5-116 Instrument Setup ........................5-117 Overview ..........................5-117 Placing Labels on a Rack ....................5-118 Wash Solution Box and Waste Container Placement ............5-120 IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-1...

  • Page 102: System Software Configuration

    System Software Configuration Overview Introduction In System Setup several features of the IMMAGE 800 Immunochemistry System interface can be customized for the individual laboratory’s requirements. Setup maintains the default parameters used for configuring the IMMAGE 800 interface. These configurations can be changed when the system status is in Standby.
  • Page 103 Setup screen. Step Action Select Setup from the menu bar. Choose the desired setup option from a numbered button. (Refer to Figure 5.1.) E011414S.EPS Figure 5.1 Setup Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-3...

  • Page 104: Configuring The Chemistry Menu

    Choose the position for the chemistry. Choose one: • Type the Beckman Coulter chemistry acronym if known (e.g., IGG). • Select Beckman Chems [F1] to display a list of all Beckman Coulter chemistries that have a protocol on the system and select the appropriate chemistry.
  • Page 105 Select Insert Chem [F5] to insert a blank position and increment the subsequent chemistries by one position. Define a chemistry for the new blank position as described in "Defining a Chemistry for a Position," in this section. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-5...
  • Page 106 • The reagent is on board the instrument. • The chemistry is programmed for a sample. • The chemistry is configured in a programmed control. This condition must be corrected before the chemistry can be deleted. System Setup IMMAGE 800 Operations Manual A11403 Page 5-6 September 2016...
  • Page 107 Select <OK> to save the changes or additions. Select <Cancel> to return to the Chemistry Configuration screen without saving changes or making additions. E010215S.EPS Figure 5.3 Define Print Names Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-7...
  • Page 108 Selecting Chemistry Tests by Chemistry for information on removing chemistries from a programmed sample. Refer to CHAPTER 7, Sample Programming, Programming a Control for information on removing chemistries from a programmed control. System Setup IMMAGE 800 Operations Manual A11403 Page 5-8 September 2016...

  • Page 109: Panel Setup

    Introduction Panel Setup Introduction The IMMAGE 800 holds up to 50 chemistry panels in its memory. Each panel is defined with a name and the chemistries that it contains. Defining New Panels The instrument status must be in Standby in order to proceed with the steps below to define a panel list.
  • Page 110 Panel Setup Defining New Panels E014094S.EPS Figure 5.4 Panels Summary Screen E014095S.EPS Figure 5.5 Panels Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-10 September 2016...
  • Page 111 To edit additional panels, select Prev Panel [F9] or Next Panel [F10] to display the previous or next panel. Repeat Steps 4-5. Select Panels Summary [F2] to return to the list of panel summaries. (Refer to Figure 5.4.) IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-11...
  • Page 112 Select the numbers beside the panels to be deleted. Select Delete Panels [F2]. Select <OK> at the Delete ALL selected panels? dialog box. Select <Cancel> to return to the list of panel summaries without deleting the panels. System Setup IMMAGE 800 Operations Manual A11403 Page 5-12 September 2016...

  • Page 113: Bar Code Setup

    Bar Code Setup Introduction Bar Code Setup Introduction The bar code symbologies recognized by the IMMAGE 800 can be selected. Additionally, the bar code parameters can be configured to match those of the sample bar codes being read. Enabling/Disabling Bar Code Symbologies The instrument status must be in Standby in order to proceed with the steps below to enable or disable bar code symbologies.
  • Page 114 NOTICE The bar code parameters of the IMMAGE 800 must match the parameters of the printed bar code labels. Review the bar code printer setup to confirm that the parameters of the IMMAGE 800 match those of the bar code printer.
  • Page 115 To disable bar code priority deselect the check box beside Bar Code Priority. If the check box is unchecked, bar code priority is disabled. The default is bar code priority enabled. IMMAGE 800 Operations Manual A11403 System Setup September 2016...
  • Page 116 Select <Cancel> to return to the Bar Code Setup screen without restoring the defaults. Additional Information CHAPTER 7, Sample Programming, Selecting Save/Next, Programming a Batch of Samples, Identifying a Batch System Setup IMMAGE 800 Operations Manual A11403 Page 5-16 September 2016...

  • Page 117: Reference Interval Setup

    Select the sample type. The default is serum. Select the options button <▼> below Sex. Select the sex. The default is M/F (Male/Female). Go to "Defining/Editing Intervals and Ranges." IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-17...
  • Page 118 Entry choices Low Age Range/High Age Range 0-999 Age unit field next to the low and high age fields Y (Years) (default) H (Hours) D (Days) W (Weeks) M (Months) System Setup IMMAGE 800 Operations Manual A11403 Page 5-18 September 2016...
  • Page 119 Optional entry: Type the low and/or high critical range numbers in the Low and/or High Critical Range fields. The critical range numbers must be outside of the reference interval. (1 of 2) IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-19...
  • Page 120 Repeat Steps 4-5. Select Prev Chem [F9] or Next Chem [F10] to move to other chemistries/ calculations. Repeat Steps 4-5. Select any icon from the menu bar to exit the screen. System Setup IMMAGE 800 Operations Manual A11403 Page 5-20 September 2016...
  • Page 121 Select <OK> to clear all the intervals and ranges for the chemistry(ies)/ calculation(s) selected. Select <Cancel> to return to the Reference Interval/Critical Ranges dialog box without clearing intervals and ranges. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-21...
  • Page 122 Select <Define Edit> (Refer to Figure 5.7.) Select a field on the line below where a line will be inserted. Select Insert Line [F1]. A blank line will be inserted. (1 of 2) System Setup IMMAGE 800 Operations Manual A11403 Page 5-22 September 2016...
  • Page 123 Select a field on the line being deleted. Select Delete Line [F2]. Select <OK> to delete the intervals and ranges. Select <Cancel> to return to the Reference Interval/Critical Ranges screen without deleting the line. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-23...
  • Page 124 All definitions for each chemistry/calculation chosen will print. Additional Information Refer to Configuring the Chemistry Menu and to Calculations Setup in this chapter for chemistry and calculations setup information. System Setup IMMAGE 800 Operations Manual A11403 Page 5-24 September 2016...

  • Page 125: Report Setup

    If desired, type the address of the facility in the four Facility Address fields (4 lines of up to 60 alphanumeric characters each). The default report header is blank. E014090S.EPS Figure 5.9 Report Setup Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-25...
  • Page 126 Select the check box next to Patient Report Calibration Report Control Report to disable the automatic printing of patient, calibration, or control reports respectively. The default is all three reports are automatically printed (checked). System Setup IMMAGE 800 Operations Manual A11403 Page 5-26 September 2016...
  • Page 127 Select <OK> at the confirmation screen to restore the defaults. Select <Cancel> to return to the Report Setup screen without restoring the defaults. Additional Information For examples of report formats, refer to APPENDIX B, Reports. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-27...

  • Page 128: Calculations Setup

    Introduction Calculations Setup Introduction There are 12 Beckman Coulter defined calculations that can be enabled for the IMMAGE 800. The system will automatically calculate and print the final calculation on reports when the chemistries necessary for the calculation are run.
  • Page 129 Calculations Setup Units in Calculations Table 5.3 Calculations Available on IMMAGE 800 , continued Calculation Chemistries Run for Formula Name Calculation ALB Index Albumin (CSF and CSF ALB/serum ALB serum) IGG Index IGG (CSF and serum) CSF IGG/serum IGG IGA Index...
  • Page 130 If the Excretion Rate Calculation is enabled, go to "Selecting Urine Chemistries for Excretion Rate Calculations". (2 of 2) E014091S.EPS Figure 5.10 Calculations Summary Screen E010306S.EPS Figure 5.11 Calculations Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-30 September 2016...
  • Page 131 Select <OK> to return to the Calculations Summary screen. Select <Cancel> to return to the Calculations Summary screen without changing the urine chemistry definition. E010307S.EPS Figure 5.12 Define Timed Urine Chemistries Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-31...
  • Page 132 Select <OK> to return to the Calculations Summary screen. Select <Cancel> to return to the Calculations Summary screen without changing the timed urine chemistry definition. System Setup IMMAGE 800 Operations Manual A11403 Page 5-32 September 2016...
  • Page 133 Variables Variables An IMMAGE 800 variable is a placeholder which may represent more than one number. A maximum of six variables may be defined for use in Custom Calculations. The numeric value for a variable is assigned during sample programming and that value will be used for the Custom Calculation on that particular sample.
  • Page 134 Select Save Calc [F2] To save the calculation defined. Select Calc Summary [F1] to return to the Calculation Summary screen. Select any icon from the menu bar to exit. System Setup IMMAGE 800 Operations Manual A11403 Page 5-34 September 2016...
  • Page 135 System Setup. (Refer to Default Setup, "Setting the Default Sample Type" in this chapter.) The default sample type for Sample Type 2 [2] is None. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-35...
  • Page 136 Enter the number(s) corresponding to the Custom Calculations in the Option No. field. Select Delete Calc [F4]. Select <OK> to delete the Custom Calculations. Select <Cancel> to return to the Calculations Summary screen without deleting the Custom Calculations. System Setup IMMAGE 800 Operations Manual A11403 Page 5-36 September 2016...

  • Page 137: Units Setup

    Introduction Units can be selected for reporting with the results and displayed throughout the IMMAGE 800 system for each chemistry. Selecting Units for Each Chemistry The instrument status must be in Standby in order to proceed with the steps below to select the desired units for a chemistry.
  • Page 138 Units Setup Selecting Units for Each Chemistry E011415S.EPS Figure 5.13 Units/Non-Standard Dilutions Screen E010221S.EPS Figure 5.14 Units Dialog Box E010220S.EPS Figure 5.15 Units Conversion Dialog Box System Setup IMMAGE 800 Operations Manual A11403 Page 5-38 September 2016...
  • Page 139 Select Restore Default [F1]. (Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual.) Select <OK> to restore the defaults for units and standard dilutions. Select <Cancel> to return to the Units Setup screen without restoring the defaults. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-39...

  • Page 140: Selecting Non-Standard Dilutions As Default For Each Chemistry

    If the original sample was programmed to run with a standard dilution, and later you changed the default dilution to a non-standard dilution, the sample will be rerun with the standard dilution. The default dilution used for samples programmed as controls is unaffected. System Setup IMMAGE 800 Operations Manual A11403 Page 5-40 September 2016...
  • Page 141 Selecting Non-Standard Dilutions as Default for Each Chemistry Selecting a Non-Standard Dilution E011416S.EPS Figure 5.16 Non-Standard Dilutions Display IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-41...

  • Page 142: Configuring Antigen Excess Testing

    A checkmark in the box indicates AGXS is enabled for that chemistry. Select the check box to remove the check and disable the AGXS testing. E010223S.EPS Figure 5.17 Antigen Excess Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-42 September 2016...
  • Page 143 Step Action From the Setup screen, select <8> Antigen Excess. Pressing Restore Default [F1] will set AGXS testing to enabled for all appropriate chemistries requiring AGXS testing. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-43...

  • Page 144: Date And Time Setup

    <3> Abbreviated Month (Jan) <4> Full Month (January) Format the year by selecting the button beside Year Format. Select either: <1> 2 Digits <2> 4 Digits (1 of 2) System Setup IMMAGE 800 Operations Manual A11403 Page 5-44 September 2016...
  • Page 145 • delete the current separator in the Separator field. • type in the appropriate separator (any non-alphabetic character). Example: "/". (2 of 2) E010224S.EPS Figure 5.18 Date and Time Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-45...
  • Page 146 Day Format Leading Zero (01) Month Format Leading Zero (01) Year Format 1996 (four-digit year) Separator Time Display Format Defaults Time Format 24 Hour Hour Format Leading Zero (01) Separator System Setup IMMAGE 800 Operations Manual A11403 Page 5-46 September 2016...
  • Page 147 "96". Select <OK> to save the changes. Select <Cancel> to return to the Date and Time screen without saving the changes. E010225S.EPS Figure 5.19 Change Date Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-47...
  • Page 148 Select <OK> to save the changes. Select <Cancel> to return to the Date and Time screen without saving the changes. E010226S.EPS Figure 5.20 Change Time Dialog Box (24 hour format) System Setup IMMAGE 800 Operations Manual A11403 Page 5-48 September 2016...
  • Page 149 1 hour will have results and load lists from both runs. If these results and load lists are recalled by date and time, both sets of results and load lists will display. IMMAGE 800 Operations Manual A11403 System Setup September 2016...

  • Page 150: Host Communications Setup

    Refer to Restoring Defaults in this section for default settings. These parameters should be set by the person configuring the connection between the IMMAGE 800 and the LIS. Further information about all of the host communications parameters is found in the IMMAGE Immunochemistry Systems Host Interface Specifications.
  • Page 151 The communications port parameters must be set to match those of the LIS. The instrument status must be in Standby in order to proceed with the steps below to set the computer port parameters for communications of the IMMAGE 800 to a host computer.
  • Page 152 Setting the Timeout Value Setting the Timeout Value The timeout value is the time the IMMAGE 800 will wait for an answer to a query of the host before timing out and canceling the query. The instrument status must be in Standby in order to proceed with the steps below to set the timeout value.
  • Page 153 From the Setup screen, select <10> Host Communications. (Refer to Figure 5.21.) Select the check box next to Continuous Numbering Mode to enable continuous numbering. Deselect the check box to disable Continuous Numbering Mode. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-53...
  • Page 154 Selecting Request Information Mode The request information mode determines whether the IMMAGE 800 queries for one or multiple samples at a time. The optimal setting for this mode is determined by how the LIS processes the requests (real-time vs. batch processing).
  • Page 155 Figure 5.21.) Select Restore Default [F1]. (Refer to Table 5.6.) Select <OK> to restore the defaults. Select <Cancel> to return to the Host Communications Parameters screen without restoring the defaults. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-55...
  • Page 156 Continuous Numbering Mode Enabled Operational Mode None Request Information Mode Single Message Header Mode Abbreviated Header Additional Information For additional information refer to IMMAGE Immunochemistry Systems Host Interface Specifications. System Setup IMMAGE 800 Operations Manual A11403 Page 5-56 September 2016...

  • Page 157: Default Setup

    The selection will be shown in the Default Sample Type field. Select <OK> to return to the Setup dialog box and change the sample type. Select <Cancel> to return to the Setup dialog box without changing the sample type. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-57...
  • Page 158 Type the desired number of system replicates (1 to 9) in the System Replicates field. Select <OK> to return to the Chemistry Configuration screen. Select <Cancel> to return to the Chemistry Configuration screen without changing the statistics setup. System Setup IMMAGE 800 Operations Manual A11403 Page 5-58 September 2016...
  • Page 159 Default Sample Type: serum System Replicates: 1 Post Run Summary Time: none Select <OK> to restore defaults. Select <Cancel> to return to the Setup dialog box without restoring the defaults. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-59...

  • Page 160: Sample Comments Setup

    Introduction Sample Comments Setup Introduction Up to 20 sample comments may be predefined on the IMMAGE 800 Immunochemistry System for use when programming samples on the instrument. These will be presented in a numbered menu when programming samples. Defining New Sample Comment The instrument status must be in Standby in order to proceed with the steps below to define samples comments.
  • Page 161 The instrument status must be in Standby in order to proceed with the steps below to edit a sample comment. Step Action From the Setup screen, select <12> Sample Comments. (Refer to Figure 5.23.) Choose the comment to be edited. Edit the comment. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-61...

  • Page 162: Demographics Setup

    Select the check boxes beside the fields to be accessible in the Demographics screen of sample programming. Checked fields will be accessible, unchecked fields will not be accessible in sample programming. E010230S.EPS Figure 5.24 Demographics Setup Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-62 September 2016...
  • Page 163 From the Setup screen, select <13> Demographics Setup. Select Restore Default [F1]. The default is all fields accessible. Select <OK> to restore defaults. Select <Cancel> to return to the Demographics Setup screen without restoring the defaults. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-63...

  • Page 164: Printer Setup

    Default is U.S. Domestic (8 ½ × 11 inches). E010231S.EPS Figure 5.25 Printer Setup Dialog Box Restoring Default To restore the paper size default, select <Restore Default> from the Printer Setup dialog box. System Setup IMMAGE 800 Operations Manual A11403 Page 5-64 September 2016...

  • Page 165: Language Setup

    Introduction A language can be selected for use for system operations and printouts on the IMMAGE 800. The keyboard should match the language. Changing the Displayed/Printed Language The instrument status must be in Standby in order to proceed with the steps below to change the language.

  • Page 166: Loading The Chemistry Protocol Diskette

    Immunochemistry system. It contains essential non-lot specific information about how to run each chemistry. When to Load the Protocol Diskette The chemistry protocol diskette is loaded when the IMMAGE 800 is installed. When new chemistries become available, a new diskette is provided. Loading the Protocol Diskette The instrument status must be in Standby in order to proceed with the steps below to load the chemistry protocols onto the hard drive of the computer.

  • Page 167: Instrument Serial Number Setup

    Type the instrument serial number in the Serial Number field (up to 7 alphanumeric characters). Select <OK> to enter the serial number. <Cancel> to return to the Setup screen without entering the serial number. E010295S.EPS Figure 5.27 Serial Number Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-67...

  • Page 168: User-Defined Reagent Chemistry Setup

    Precautions CAUTION Since Beckman Coulter does not manufacture or otherwise control the sample and reagents that may be used in user-defined reagent applications, Beckman Coulter makes no warranty whatsoever with respect to such sample and reagent...

  • Page 169: Setting Up A Udr Chemistry

    A Define/Edit User screen appears. Refer to Figure 5.31. Enter a new user name in the Username field. Enter your password in the Password field. Enter the same password in the Confirm Password field. IMMAGE 800 Operations Manual A11403 System Setup September 2016...
  • Page 170 Select <Cancel> to return to the Password Protection Mode Screen. Select <Exit> to return to the User Defined Chemistries screen. E011417S.EPS Figure 5.28 User-Defined Chemistries Screen E011434S.EPS Figure 5.29 User Login Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-70 September 2016...
  • Page 171 Setting Up a UDR Chemistry Password Setup Procedure E011435S.EPS Figure 5.30 UDR User Setup/Password Protection Mode Screen E011436S.EPS Figure 5.31 Define/Edit User Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-71...
  • Page 172 Select Define/Edit [F1]. (Refer to Figure 5.32 and Figure 5.33.) Continue to "Beginning a New UDR Protocol Definition" in this chapter. E011418S.EPS Figure 5.32 Define/Edit User-Defined Chemistry Screen, Page 1 System Setup IMMAGE 800 Operations Manual A11403 Page 5-72 September 2016...
  • Page 173 Setting Up a UDR Chemistry Accessing Define/Edit E011428S.EPS Figure 5.33 Define/Edit User-Defined Chemistry Screen, Page 2 IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-73...

  • Page 174: Defining A Udr Chemistry

    Reagent Expiration Date in order as defined Reagent will be flagged on Date in Date Setup reports as expired after this date. (1 of 2) System Setup IMMAGE 800 Operations Manual A11403 Page 5-74 September 2016...
  • Page 175 Determines dilution ratio for sample predilution. Reaction Time Select from list: 1.5 to 10 Interval in which reaction minutes readings are taken after addition of the last reagent to the reaction mixture. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-75...
  • Page 176 Up to 6 digits with a Identifies concentration value decimal point, or seven for each calibration level in digits. ascending order where Level 1 is the lowest concentration value. System Setup IMMAGE 800 Operations Manual A11403 Page 5-76 September 2016...
  • Page 177 Diluted Sample > Compartment A Reagent starts reaction 0 µL Between 195-235 µL Compartment B Reagent > Neat or Diluted Sample > Incubate > Compartment A Reagent starts reaction IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-77...
  • Page 178 Define/Edit User-Defined Chemistry screen (Refer to Figure 5.32). Run UDR samples and perform single-point UDR calibration updates. Additional Information Refer to IMMAGE 800 Immunochemistry System Operation Manual CHAPTER 3, Theory of Operations, Principles of Methodologies for theory of operation information.
  • Page 179 ******* in the results column on the results display and printout instead of a numerical result. AGXS flagging shall not apply during UDR Rate Mode runs. IMMAGE 800 Operations Manual A11403 System Setup September 2016...
  • Page 180 Buffer options button beside the Buffer field. Select the buffer type from the list. Select the Diluent options <▼> button beside the Diluent field. Select the diluent type from the list. (1 of 3) System Setup IMMAGE 800 Operations Manual A11403 Page 5-80 September 2016...
  • Page 181 Enter 1:1 for an undiluted sample. The Sample Dilution field automatically displays the same value as the Cal Dilution field. No input is allowed until after calibration and approval. (2 of 3) IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-81...
  • Page 182 Select the reaction time number from the list. Select the <Page Down> button to go to Page 2 of the Define/Edit User- Defined Chemistry screen. Continue to "Defining UDR Calibration Information." (3 of 3) System Setup IMMAGE 800 Operations Manual A11403 Page 5-82 September 2016...

  • Page 183: Defining Udr Calibration Information

    Config [F9] to configure the UDR chemistry. (Refer to Configuring the Chemistry Menu in this chapter.) From the Chemistry Configuration screen, select UDR Main [F9] to return to the User-Defined Chemistries screens. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-83...

  • Page 184: Deleting Udr Chemistries

    When the UDR definition is deleted, the UDR reference intervals and all associated, non-archived patient results are deleted. Refer to IMMAGE 800 Immunochemistry System Operation Manual CHAPTER 10, Utilities, Backup/Restore. The instrument status must be in Standby in order to proceed with the steps below to delete a UDR definition.

  • Page 185: Editing Udr Definitions

    If the serial number is changed in the protocol definition, the cartridge identified by the overwritten serial number is no longer usable, regardless of the number of tests remaining. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-85...
  • Page 186 Serial Number Status: Calibrated Refill Cartridge Sample Dilution Clears Program No Effect AGXS Limit Status: Calibrated All Other Parameters Clears Program Cancels Calibration Clears AGXS Limit Status: Uncalibrated Disable Flagging System Setup IMMAGE 800 Operations Manual A11403 Page 5-86 September 2016...

  • Page 187: Loading Udr Reagent Cartridges

    Loading UDR Reagent Cartridges Introduction The UDR reagent cartridges must be loaded before performing a run. Description of Cartridge The UDR cartridge provided by Beckman Coulter contains the following information: • Cartridge lot number • Cartridge serial number. Limits • Twelve cartridges may be loaded in the reagents carousel at one time.
  • Page 188 Cartridge Serial number as defined in Figure 5.32 Tests left Number of tests remaining from tests per cartridge defined in Figure 5.32. Total tests left Number of tests remaining from 300 total tests per cartridge. System Setup IMMAGE 800 Operations Manual A11403 Page 5-88 September 2016...
  • Page 189 Loading UDR Reagent Cartridges Removing UDR Cartridges Removing UDR Cartridges Follow the instructions in CHAPTER 6, Reagents/Calibration, Loading/Unloading Reagent Cartridges, "Removing Cartridges from The Reagent Carousel." IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-89...

  • Page 190: Loading/Clearing Udr Buffer And Diluent

    Loading/Clearing UDR Buffer and Diluent Introduction Beckman Coulter IMMAGE 800 buffers and diluents, or user-prepared solutions, may be used as UDR buffer and diluent. However, the UDR buffer and diluent are given a specific name on the sample or reagent carousel. The positions and lot numbers of UDR buffer and diluent must be entered into the computer.
  • Page 191 The % Remaining volume on the Buffer/Diluent Status dialog box is updated during a sample run. Clearing a UDR Buffer/Diluent Position Refer to CHAPTER 6, Reagents/Calibration, Loading/Clearing Buffers and Diluents, "Clearing a Buffer or Diluent Position." IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-91...

  • Page 192: Programming Rate Mode

    Select Cancel [F10] to exit the screen without saving the program. Repeat Steps 1-7 to program additional racks for rate mode. Print a Load List from Sample Programming. Load the samples on the sample carousel. (1 of 2) System Setup IMMAGE 800 Operations Manual A11403 Page 5-92 September 2016...
  • Page 193 Select <OK> in the Check Dilution Segments dialog box to start the run. Select <Cancel> to exit without starting the run. (2 of 2) E014049S.EPS Figure 5.39 UDR Rate Mode Dialog Box E014050S.EPS Figure 5.40 UDR Rate Mode Assign Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-93...
  • Page 194 Load List. Refer to CHAPTER 8, Results Recall, Printing Recalled Results to reprint UDR rate mode results. Refer to APPENDIX B, Reports for an example of a Rate Mode report. System Setup IMMAGE 800 Operations Manual A11403 Page 5-94 September 2016...

  • Page 195: Calibrating A Udr Chemistry

    (IR) for each calibrator replicate is generated. Once the calibration is approved, the UDR cal status is in Calibrated and UDR chemistries can be run with other Beckman Coulter chemistries. Using the UDR calibration data, the system will calculate a final result in the concentration units selected in the protocol.
  • Page 196 Repeat Steps 4-7 to program additional racks for calibration of other UDR chemistries. (2 of 2) E014051S.EPS Figure 5.41 UDR Request Cal Dialog Box E014052S.EPS Figure 5.42 UDR Multi-point Cal Assign Screen System Setup IMMAGE 800 Operations Manual A11403 Page 5-96 September 2016...
  • Page 197 Select Save [F9] or a menu bar icon to save the calibration program for the displayed chemistry. Select Cancel [F10] to exit the screen without saving any calibration programs. Repeat Steps 1-7 to program additional racks for calibration of other UDR chemistries. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-97...
  • Page 198 Select Print [F10] to print the load list or UDRCal [F9] to return to the UDR Cal screen. (Refer to APPENDIX B, Reports for an example of a Calibration Load List.) System Setup IMMAGE 800 Operations Manual A11403 Page 5-98 September 2016...
  • Page 199 Select <Cancel> to exit without starting the run. When the calibration run is finished, a multi-point or single-point UDR Calibration Results report is printed. Continue to "Approving a UDR Calibration." IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-99...
  • Page 200 Select <Cancel> to return to the User-Defined Chemistries screen. E014054S.EPS Figure 5.45 UDR Cancel Cal Dialog Box System Setup IMMAGE 800 Operations Manual A11403 Page 5-100 September 2016...
  • Page 201 The calibration results for this rack will be deleted. After clearing the rack, the calibration results cannot be displayed with the current model, with a different model, or be printed. E014055S.EPS Figure 5.46 Clear UDR Calibration Racks Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-101...

  • Page 202: Approving A Calibration

    = A + Bx + Cx Polynomial A011364L.EPS Third Order y = A + Bx + Cx + Dx Polynomial A011365L.EPS Four Parameter A - D Logistic ⎧ ⎫ ⎩ ⎭ A011366L.EPS System Setup IMMAGE 800 Operations Manual A11403 Page 5-102 September 2016...
  • Page 203 Approving a Calibration Curve-Fit Model Descriptions E014056S.EPS Figure 5.47 Example of First Order Polynomial Calibration E014057S.EPS Figure 5.48 Example of Second Order Polynomial Calibration IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-103...
  • Page 204 Approving a Calibration Curve-Fit Model Descriptions E014058S.EPS Figure 5.49 Example of Third Order Polynomial Calibration E014059S.EPS Figure 5.50 Example of Four Parameter Logistic Calibration System Setup IMMAGE 800 Operations Manual A11403 Page 5-104 September 2016...
  • Page 205 Approving a Calibration Curve-Fit Model Descriptions E014060S.EPS Figure 5.51 Example of Composite Calibration E011423S.EPS Figure 5.52 User-Defined Single-Point Update Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-105...
  • Page 206 In this case it is recommended that UDR calibration racks with incomplete replicates be removed from the system following calibration approval. System Setup IMMAGE 800 Operations Manual A11403 Page 5-106 September 2016...
  • Page 207 When the final calibration model has been selected, clear the UDR calibration rack. Refer to "Clearing a UDR Cal Rack" in this chapter. E014061S.EPS Figure 5.53 User-Defined Model Dialog Box IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-107...
  • Page 208 Another model cannot be tested. When the calibration model has been approved, clear the UDR calibration rack. Refer to "Clearing a UDR Cal Rack" in this chapter. System Setup IMMAGE 800 Operations Manual A11403 Page 5-108 September 2016...
  • Page 209 Select Plot to plot the curve. A typical Robust Means Data Curve is shown in Figure 5.56. Select <Exit> to return to the previous screen. E011437S.EPS Figure 5.54 User-Defined Reports Screen IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-109...
  • Page 210 Approving a Calibration Plotting a Robust Means Data Curve E011438S.EPS Figure 5.55 Plot Robust Means Data Curve Window E011439S.EPS Figure 5.56 Plot Robust Means Data Curve System Setup IMMAGE 800 Operations Manual A11403 Page 5-110 September 2016...
  • Page 211 Select <Print> to print the the Plot Robust Means Data Report. Select [Ctrl, P] on the keyboard to print the Plot Robust Means Data Curve. E011440S.EPS Figure 5.57 Plot Robust Means Data Curve - Time Range Window IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-111...

  • Page 212: Printing Udr Reports

    Rate Mode Results Identifies UDR instrument responses per replicate of each UDR sample for the selected chemistry. Patient Results Identifies UDR concentrations per replicate of patient sample programmed. System Setup IMMAGE 800 Operations Manual A11403 Page 5-112 September 2016...
  • Page 213 Select <Cancel> to return to the User-Defined Chemistry screen. Printing UDR Rate Mode and Patient Results Follow the instructions in CHAPTER 8, Results Recall, Printing Recalled Results to reprint UDR rate mode and patient results. IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-113...

  • Page 214: Setting Up Udr Reference Intervals And Panels

    Setting Up UDR Reference Intervals and Panels UDR Reference Interval and Panel Setup UDR reference intervals and panels are defined like other Beckman Coulter chemistries from the Reference Interval Setup and Panel Setup screens. (Refer to Reference Interval Setup, "Defining/Editing Intervals and Ranges" and Panel Setup, "Defining New Panels"...

  • Page 215: Defining Udr Quality Control

    UDR Quality Control Definition Defining UDR Quality Control UDR Quality Control Definition UDR quality controls are defined like other Beckman Coulter chemistries from the Quality Control screen. (Refer to CHAPTER 9, Quality Control, Defining a Control.) IMMAGE 800 Operations Manual A11403...

  • Page 216: Programming A Udr Sample

    UDR Programming Reference Programming a UDR Sample UDR Programming Reference The UDR chemistry is programmed like an other Beckman Coulter chemistry from the Program Sample screen except that AGXS check cannot be chosen. (Refer to CHAPTER 7, Sample Programming.) System Setup...

  • Page 217: Instrument Setup

    Some parts of the instrument hardware require a one-time setup prior to a sample run. This section explains: • Rack bar code label placement • Wash solution box placement • Waste container placement IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-117...

  • Page 218: Placing Labels On A Rack

    Place the bar coded rack label on the side of the rack as pictured in Figure 5.58. A010084P.EPS 1. Rack bar code label Figure 5.58 Rack Bar Code Label Placement System Setup IMMAGE 800 Operations Manual A11403 Page 5-118 September 2016...
  • Page 219 Placing the Rack Number Label on the Rack Place the rack number label on the top of the rack as pictured in Figure 5.59. A010085P.EPS 1. Rack number label Figure 5.59 Rack Number Label Placement IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5-119...

  • Page 220: Wash Solution Box And Waste Container Placement

    The wash solution box is placed close enough to the instrument to allow connection of the wash solution tube. Waste Container Placement The waste container must be placed with the opening of the waste container no higher than the top of the instrument. System Setup IMMAGE 800 Operations Manual A11403 Page 5-120 September 2016...

  • Page 221: Chapter 6 Reagents/Calibration

    Requesting and Canceling Calibration .................. 6-26 Loading Calibrators on the Sample Carousel ............... 6-30 Starting a Calibration Run ..................... 6-33 Calibration Results ........................ 6-34 Re-Enabling Calibration ....................... 6-35 Cal Options ........................... 6-36 IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-1...

  • Page 222: Reagents

    This section explains: • Reagent Status/Calibration Status Screen • Loading Reagent/Calibrator Bar Coded Parameters • Displaying/Deleting Reagent Parameters • Loading/Clearing Buffers and Diluents • Loading Wash Solution • Loading/Unloading Reagent Cartridges Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-2 September 2016...

  • Page 223: Reagent Status/Calibration Status Screen

    Serial number of the reagent cartridge Cal Status Current calibration status of the reagent cartridge Cal date Date of calibration Cal ID Name of calibrator Options button <▼> Calibrator information beside the Cal ID IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-3...
  • Page 224 Cancel Request [F7] Cancels a calibration after it has been requested. Read Cards [F8] Reads reagent or calibrator bar code cards when cards are placed on the sample carousel racks. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-4 September 2016...

  • Page 225: Loading Reagent/Calibrator Bar Coded Parameters

    Select <OK> to start the bar code read and go to Step 8. Select <Cancel> to return to the Reagent Status/Calibration Status screen without reading the bar code cards. (1 of 2) IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-5...
  • Page 226 To exit the Cards Read dialog box, even if the bar code read is not finished, select <OK>. (2 of 2) A010072P .EPS Figure 6.2 Loading Reagent/Calibrator Bar Code Cards on a Rack Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-6 September 2016...

  • Page 227: Displaying/Deleting Reagent Parameters

    Select <Go To> and type the Chem and Lot number. Select <OK> from the Reagent Lot Parameters dialog box when finished viewing the reagent lot parameters. E010239S.EPS Figure 6.3 Reagent Summary Dialog Box IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-7...
  • Page 228 Select <OK> from the Delete Reagent Lot Confirmation dialog box to delete the parameters. Select <Cancel> to return to the Reagent Summary dialog box without deleting parameters. E010300S.EPS Figure 6.5 Delete Reagent Lot Confirmation Dialog Box Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-8 September 2016...

  • Page 229: Loading/Clearing Buffers And Diluents

    Loading/Clearing Buffers and Diluents Introduction Reaction buffers and sample diluents must be placed on the IMMAGE 800 and their positions and lot numbers must be entered into the computer. • Up to 4 bottles of reaction buffer may be placed on the inner section of the reagent carousel.
  • Page 230 Follow "Replacing the Same Lot," in this section, to place bottles on the carousel(s). NOTICE Recalibration of affected chemistries may be necessary when buffer or diluent lots are changed. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-10 September 2016...
  • Page 231 Buffer/Diluent Status dialog box. Close the reagent or sample compartment cover. The IMMAGE 800 retains the lot and position number. The % Remaining will be updated when the next run is started. After Loading Buffers and Diluents •...
  • Page 232 Select the options button <▼> beside the position to be cleared. Select <Clear> to clear the position. Select <Cancel> to return to the Reagent Status/Calibration Status screen without clearing the position. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-12 September 2016...

  • Page 233: Loading Wash Solution

    Verify that the blue and orange tubings are attached to the top of the cap. No software intervention is required. Priming is not required. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016...

  • Page 234: Loading/Unloading Reagent Cartridges

    Loading/Unloading Reagent Cartridges Introduction The reagent cartridges must be loaded before performing a run. Description of Cartridge Bar Code The Beckman Coulter reagent cartridge bar code contains the following information: • Chem ID • Reagent lot number • Reagent cartridge serial number Limits •...
  • Page 235 CHAPTER 10, Utilities, Troubleshooting.) the cartridge is expired a warning message. the cartridge is exhausted "Tests Left" as zero. (2 of 2) A010087P.EPS Figure 6.7 Loading Reagent Cartridges on the Reagent Carousel IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-15...
  • Page 236 Removing the Reagent Carousel Removing the Reagent Carousel The instrument status must be in Standby in order to proceed with the steps below to remove the reagent carousel from the IMMAGE 800 upon completion of the daily workload. Step Action Open the reagent compartment cover.

  • Page 237: Calibration

    • Checking Calibration Status • Requesting and Canceling Calibration • Loading Calibrators on the Sample Carousel • Starting a Calibration Run • Calibration Results • Re-enabling Calibration • Cal Options IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-17...

  • Page 238: Checking Calibration Status

    Check the calibration status of the reagents from the Reagent Status/ Calibration Status screen under the Cal Status heading. (Refer to Figure 6.8.) Select Control [P] to print the Reagent Status/Calibration Status screen(s). Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-18 September 2016...
  • Page 239 Select the <Display> button to view the reagent lot parameters. (Refer to Figure 6.4.) Select <Go To> and type the Chem and Lot number. Select <OK> from the Reagent Lot Parameters dialog box when finished viewing the reagent lot parameters. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-19...
  • Page 240 Checking Calibration Status Verifying the Cal Status of Reagent Parameters in the Database E010239S.EPS Figure 6.9 Reagent Summary Dialog Box Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-20 September 2016...

  • Page 241: Calibration History

    Calibration. The calibration status of the test changes to Cal Re-enable. The calibrations display ascending date/time order, with the oldest calibration listed first. Select <OK> to return to the Reagent/Status/Calibration screen. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-21...

  • Page 242: Cartridge-Specific Calibration

    The number of tests remaining in a cartridge to allow a tests: cartridge-specific calibration. This number is determined by Beckman Coulter on a per chemistry basis and is coded into the reagent bar code card. *Requested: Calibration status of a requested chemistry that will become a cartridge-specific calibration.
  • Page 243 Uncalibrated new to the system, for all cartridges of that lot on the system. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-23...
  • Page 244 Requesting and Canceling Calibration in this desired, chapter. reestablishment of cartridge- reenable calibration. Refer to Re-Enabling specific calibration is desired, Calibration in this chapter. (1 of 2) Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-24 September 2016...
  • Page 245 <▼> beside Cal ID for is desired, the calibrator of the specific chemistry. The Calibration Information screen will indicate whether the calibration was cartridge-specific. (2 of 2) IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-25...

  • Page 246: Requesting And Canceling Calibration

    • ALL chemistries requested for a STAT calibrator will be calibrated STAT. • A STAT calibrator will be run before any other calibrator or sample. Go to Checking and Clearing Racks. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-26 September 2016...
  • Page 247 Available. Available racks have at least one position that is not programmed. If the rack is Not Available, select Clear Racks [F1]. (Refer to Figure 6.11.) (1 of 2) IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-27...
  • Page 248 Select Save [F9] to save the request. Select Cancel [F10] to return to the Reagent Status/Calibration Status screen without saving. not bar coded Go to Assigning Calibrator Rack and Position in this section. (2 of 2) Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-28 September 2016...
  • Page 249 Select the button(s) to the left of the requested chemistries to be canceled. Select Cancel Request [F7]. The Cal Status of the canceled chemistries will return to the status prior to calibration request. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-29...

  • Page 250: Loading Calibrators On The Sample Carousel

    Place racks containing calibrators in position A and B. Controls and/or patient samples may be placed in other positions on the sample carousel. (Refer to CHAPTER 7, Sample Programming.) Close the sample compartment cover. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-30 September 2016...
  • Page 251 Place racks containing calibrators in position A and B. Controls and/or patient samples may be placed in any other positions on the sample carousel. (Refer to CHAPTER 7, Sample Programming.) Close the sample compartment cover. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-31...
  • Page 252 Programming Samples and Controls E010241S.EPS Figure 6.12 Cal Load List Dialog Box Programming Samples and Controls Samples and controls may be programmed on a calibration run. (Refer to CHAPTER 7, Sample Programming.) Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-32 September 2016...

  • Page 253: Starting A Calibration Run

    Select Run. Additional Information Refer to CHAPTER 2, System Description for information on how the IMMAGE 800 processes a calibrator and for test tube and sample cup sizes. Refer to CHAPTER 3, Theory of Operations for the theory of calibration.

  • Page 254: Calibration Results

    Failed Calibration When calibration fails: • Samples programmed for a reagent that fails calibration will be displayed and printed on the report as Pending. • Refer to CHAPTER 10, Utilities, Troubleshooting. Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-34 September 2016...

  • Page 255: Re-Enabling Calibration

    • The previous calibration is re-enabled for all reagent cartridges of the same lot. • Results generated by a re-enabled calibration are flagged on the laboratory and patient chartable reports under the Instrument Code. (Refer to APPENDIX A, Instrument Codes for instrument codes.) IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-35...

  • Page 256: Cal Options

    Select <Go To> and type the Cal and Lot number. Select <OK> from the Calibrator Lot Display dialog box when finished viewing the calibrator lot parameters. E010302S.EPS Figure 6.13 Calibrator Summary Dialog Box Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-36 September 2016...
  • Page 257 Select a button beside the Cal lot to be deleted. THEN Select the <Display> button to view the calibrator lot parameters for deletion. Select <Go To> and type the Cal and Lot number. (1 of 2) IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-37...
  • Page 258 (2 of 2) Definition of Slope and Offset Slope and offset values are entered to scale a result from the IMMAGE 800 to correlate with other systems. Acceptable slope entries: 0.001 - 9999.0 Acceptable offset entries: -9999.0 - +9999.0 The result is multiplied by the slope, then the offset is added or subtracted.
  • Page 259 Cal Options Printing Slope and Offset Adjustments Printing Slope and Offset Adjustments From the Slope/Offset screen select Print [F10] to print all of the slope and offset adjustments. IMMAGE 800 Operations Manual A11403 Reagents/Calibration September 2016 Page 6-39...
  • Page 260 Cal Options Printing Slope and Offset Adjustments Reagents/Calibration IMMAGE 800 Operations Manual A11403 Page 6-40 September 2016...

  • Page 261: Chapter 7 Sample Programming

    Pausing a Run ........................... 7-55 Overview ..........................7-55 System Pause ......................... 7-56 Pausing to Load Samples ...................... 7-57 Rerunning a Sample ........................7-60 Overview ..........................7-60 Selecting Samples to be Rerun ....................7-61 IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-1...
  • Page 262 Clearing a Sample by Rack and Position ................7-78 Routine Operation ........................7-79 Overview ..........................7-79 Host Communication Status ....................7-83 Operating IMMAGE 800 in Japanese ..................7-84 Overview ..........................7-84 Computer ..........................7-85 Data/Text Entry ........................7-87 Language Conversions ......................7-91 Display Language .........................

  • Page 263: Preparing For Programming/Running

    • the dilution segments status should be checked. Segments can be cleared or left unchanged. • reagents, reaction buffers, and sample diluents should be checked. • wash solution volume should be checked. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-3...

  • Page 264: Checking And Clearing Sample Racks

    Select <Cancel> to return to the Program Sample screen without clearing racks. Select <OK> to confirm the racks to be cleared. Select <Cancel> to return to the Clear Samples dialog box. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-4 September 2016...
  • Page 265 Refer to Requesting a Load List in this chapter for more information on the Load List function. Refer to Clearing a Sample in this chapter for more information on the Clear Samples function. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-5...

  • Page 266: Checking Status And Clearing/Replacing Dilution Segments

    Select <OK>. not to be cleared Select <Cancel>. After Clearing Segments Always replace the cleared dilution segments with unused segments on the sample carousel before a run is started. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-6 September 2016...
  • Page 267 Repeat Steps 2-5 until all desired segments are replaced. A011427P.EPS 1. Dilution Segment Figure 7.1 Replacing a Dilution Segment Additional information Refer to CHAPTER 11, System Status/Instrument Commands for more information on Dilution Segments status. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-7...

  • Page 268: Checking Reagents, Buffers, And Diluents

    Determine if the buffer and diluent types and the volume % Remaining are appropriate for the run. (Refer to CHAPTER 6, Reagents/Calibration, Loading/Clearing Buffers and Diluents, for more information.) Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-8 September 2016...

  • Page 269: Checking Wash Solution Volume

    For a more accurate estimation of wash solution usage, record the cycle count when a new wash solution box is placed on the system. Replace the box when the cycle count nears 1,000 additional tests. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...

  • Page 270: Programming A Sample

    • control samples • STAT samples Additional Information Refer to CHAPTER 2, System Description, Sample Container Information, Sample Containers Allowed, "Sample Cups," when using a sample cup. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-10 September 2016...

  • Page 271: Program Sample Screen

    Running One or more tests requested for Sample Comment the sample are running. Demographics Add chemistries and any options related to them (1 of 2) IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-11...
  • Page 272 • Indicates that antigen excess testing is enabled for a chemistry by displaying a small green box. • Displays <Page Up> and <Page Down> buttons so chemistries with numbers greater than 45 can be accessed. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-12 September 2016...
  • Page 273 Saves the current sample program and allows programming of the next sample. Additional Information Refer to CHAPTER 2, System Description, Performing Software Functions, for general information on using the software. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-13...

  • Page 274: Entering Sample Identification

    Select Samples from the menu bar. Choose the Sample ID field if the cursor is in another field. Type a Sample ID (up to 15 alphanumeric characters; a space is not allowed). Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-14 September 2016...
  • Page 275 Displaying/Editing a Sample Program A previously saved sample program can be displayed by entering either the Rack and Position or the Sample ID. The program can then be edited. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-15...

  • Page 276: Selecting Chemistry Tests By Panel

    (Example: 1, 2, 5-8). Press [Enter]. Select the number beside the desired panel(s). Select <OK> to program the panel(s). Select <Cancel> to return to the Program Sample screen without programming the panels. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-16 September 2016...
  • Page 277 A panel cannot be canceled after the sample program is saved and/or the run is started. Additional Information Refer to CHAPTER 5, System Setup, Panel Setup for more information on defining panels. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-17...

  • Page 278: Selecting Chemistry Tests By Chemistry

    If both panels and individual chemistries are selected for a sample, their Sample Types and any off-line dilutions must be the same. After Chemistry Selection After a chemistry is selected, the button is highlighted in the chemistry menu. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-18 September 2016...
  • Page 279 A chemistry cannot be canceled after the run is started. Additional Information Refer to CHAPTER 5, System Setup, Configuring the Chemistry Menu for more information on configuring the chemistry menu. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-19...

  • Page 280: Selecting A Sample Type

    Select the number beside the desired Sample Type. Panel or Control Sample Type If a panel or control is selected, the Sample Type defined for the panel or control will automatically appear. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-20 September 2016...
  • Page 281 E010254S.EPS Figure 7.4 Timed Urine Parameters Dialog Box Additional Information Refer to CHAPTER 5, System Setup, Default Setup for more information on defining a default Sample Type. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-21...

  • Page 282: Entering A Sample Comment

    Type the number of the desired Type the number of the desired comment, and press [Enter]. comment, and press [Enter]. Select the number beside the desired comment. E010255S.EPS Figure 7.5 Sample Comment Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-22 September 2016...
  • Page 283 Type a Sample Comment (up to 25 alphanumeric characters). Additional Information Refer to CHAPTER 5, System Setup, Sample Comments Setup, for more information on defining a list of Sample Comments. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-23...

  • Page 284: Entering A Patient Id

    Follow the steps below to enter a Patient ID. Step Action Select Samples from the menu bar. Choose the Patient ID field. Type a Patient ID (up to 15 alphanumeric characters). Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-24 September 2016...

  • Page 285: Entering Patient Demographics

    (Refer to Figure 7.6.) Only the STAT check box and the Sample Type and Sample Comment fields can be accessed. Individual patient demographic fields can be disabled from Setup. Disabled demographic fields cannot be accessed. E010256S.EPS Figure 7.6 Demographics Screen IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-25...
  • Page 286 • Age is automatically calculated Days: 0-999 if Date of Birth is entered. Weeks: 0-999 • Age is automatically Months: 0-999 recalculated if Age units are Years: 0-999 changed. (1 of 2) Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-26 September 2016...
  • Page 287 Refer to CHAPTER 5, System Setup, Demographics Setup for more information on disabling demographic fields and Date and Time Setup for more information on defining date and time formats. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-27...

  • Page 288: Selecting Sample Options

    Exiting the Sample Options Dialog Box Select <OK> to save the information and return to the Program Sample screen. Select <Cancel> to return to the Program Sample screen without accepting any changes. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-28 September 2016...

  • Page 289: Selecting Replicates

    Choose the Reps field beside the desired chemistry. Type the number of replicates for the test (1-9). Additional Information Refer to CHAPTER 5, System Setup, Default Setup, for more information on defining System Replicates. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-29...

  • Page 290: Antigen Excess (Agxs) Testing

    Refer to CHAPTER 3, Theory of Operation, Antigen Excess Testing for more general information on antigen excess. Refer to CHAPTER 5, System Setup, Configuring Antigen Excess Testing for more information on defining the default for AGXS testing. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-30 September 2016...

  • Page 291: Selecting Non-Standard Dilutions

    A Non-Standard Dilution can be useful when a specific sample is known to have unusually low or high test results. E011447S.EPS Figure 7.8 Non-Standard Dilutions Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-31...
  • Page 292 Select the options button <▼> in the "Non-Standard Dilution" column that is beside the desired chemistry. Type the number of the desired dilution and press [Enter]. Select the number beside the desired dilution. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-32 September 2016...

  • Page 293: Entering An Off-Line Dilution Factor

    The system will perform tests using the default dilution and out-of-range dilutions as required. The user would then need to manually multiply all test results for the sample by the user-prepared dilution factor. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...
  • Page 294 IMMAGE 800 System. When an off-line dilution is selected, diluent incompatibility is not detected by the IMMAGE 800 System. Only chemistries using the same diluent type should be run on a sample with an off-line dilution preparation.

  • Page 295: Linking/Unlinking Samples

    Select <OK> to save the link and return to the Sample Options dialog box. Select <Cancel> to return to the Sample Options dialog box without linking the samples. E010298S.EPS Figure 7.9 Link Samples Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-35...
  • Page 296 Select Main from the menu bar. Select Run. Select <OK> in the Check Dilution Segments dialog box to start the run. Select <Cancel> to exit without starting the run. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-36 September 2016...

  • Page 297: Setting Variables

    Select <Cancel> to return to the Sample Options dialog box without setting the variable. Additional Information Refer to CHAPTER 5, System Setup, Calculations Setup, for more information on special calculations. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-37...

  • Page 298: Programming A Control

    • any Pending tests are deleted from an Incomplete control sample program. Exception: if controls are programmed by bar code, the system will try to run Pending tests from an Incomplete sample. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-38 September 2016...
  • Page 299 If a control is programmed by a host computer, the Control ID sent from the host: • must be programmed for only the chemistries defined for that control. • must not match any patient Sample ID that is sent for the same run. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...
  • Page 300 Select Save [F10] to save the control program and return to the Program Sample screen. Select Cancel Edit [F9] to return to the Program Sample screen without saving the control program. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-40 September 2016...
  • Page 301 Programming a Control Programming a Non-bar Coded Control E010259S.EPS Figure 7.10 Select Control Dialog Box E010260S.EPS Figure 7.11 Program Control Screen IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-41...
  • Page 302 Rack field and Pos field of the Program known, Sample screen. Additional Information Refer to CHAPTER 9, Quality Control, Defining a Control for more information on defining controls. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-42 September 2016...

  • Page 303: Programming A Stat

    Select the STAT check box. This can be done at any time while programming a sample. Additional Information Refer to CHAPTER 6, Reagents/Calibration, Requesting and Canceling Calibration, for more information on programming a STAT calibration. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-43...

  • Page 304: Selecting Save/Next

    Selecting Save/Next [F10] from the last position on a rack will display a blank Program Sample screen. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-44 September 2016...

  • Page 305: Programming A Batch Of Samples

    Select Sample Options [F3] if replicate, AGXS testing, or dilution defaults are to be changed for the batch. (Refer to Programming a Sample, Selecting Sample Options, in this chapter for more information.) IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-45...

  • Page 306: Identifying Batch Samples

    Rack and Position numbers can be entered for samples that are not bar coded. Select End Batch [F10] when all Sample IDs are entered. E010263S.EPS Figure 7.12 Program Batch Screen, Bar Code Priority Enabled Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-46 September 2016...
  • Page 307 (Refer to Figure 7.14.) Type the desired Sample ID beside each Rack and Position. Select End Batch [F10] when all Sample IDs are entered. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...
  • Page 308 Figure 7.14 Program Batch Screen, Bar Code Priority Disabled Additional Information Refer to CHAPTER 5, System Setup, Bar Code Setup, for more information on enabling and disabling Bar Code Priority. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-48 September 2016...
  • Page 309 Type the Rack number and Position number. Type the Sample ID of the desired sample. Edit the desired information for the sample. Select Save/Next [F10]. Repeat Steps 2-4 to edit additional samples. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-49...

  • Page 310: Loading And Starting A Run

    Loading Samples Load Samples Loading and Starting a Run Loading Samples Load Samples To load prepared sample containers into racks and onto the IMMAGE 800, follow these steps. Step Action Determine in which rack and position to place sample containers.
  • Page 311 • positioned so that bar code labels (1), if used, face in the same direction as the rack bar code label (2). Position numbers (3). Figure 7.15 (2 of 3) IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-51...
  • Page 312 Press the advance button to rotate the carousel to additional positions. Racks containing calibrators must be placed in sample carousel positions A and/or B only. Figure 7.16 (3 of 3) Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-52 September 2016...

  • Page 313: Pre-Run Checklist

    Pre-run Checklist Pre-run Checklist With the IMMAGE 800 in Standby, prepare for the start of a run by performing these tasks or verifying they have been performed. Refer to appropriate sections of this guide for instructions on how to perform each task.

  • Page 314: Starting The Run

    Select <Run>. Select <OK> if dilution segment status is OK, Observe the instrument occasionally during the first 5 minutes of operation to respond to any messages that might be displayed. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-54 September 2016...

  • Page 315: Pausing A Run

    When pausing a run: • The user can pause the system for a sample load. • The user can pause the system completely. • The user can cancel the pause request. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-55...

  • Page 316: System Pause

    System Pause Introduction If the system is running and the user selects the pause option from the IMMAGE 800 main screen, the user may choose to completely pause the system. When the user selects pause, the system completes any sample that is in process and goes into Standby after the pause.

  • Page 317: Pausing To Load Samples

    Pausing to Load Samples Introduction If the system is running and the user selects the pause option from the IMMAGE 800 main screen, the user may choose to pause the system for a sample load. This type of pause allows the user to load samples without waiting for the entire sytem to complete all actions.
  • Page 318 Figure 7.18 OK to Load Samples Message Canceling a Pause Select the <Cancel> button to cancel the pause request. This will not affect the current run. (Refer to Figure 7.17.) Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-58 September 2016...
  • Page 319 Dilutions created before selecting Pause, will not be reused. In some instances, the system may have to remake previously made dilutions, and additional sample volume may be required. When using a barcoded QC, the control will rerun during Pause/Resume. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-59...

  • Page 320: Rerunning A Sample

    • The rerun results replace the original results. • Rerun results are indicated by a flag (R) on the Laboratory Report. • After a sample is rerun, all results will be collated on the result report. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-60 September 2016...

  • Page 321: Selecting Samples To Be Rerun

    Samples can be selected for rerunning by Sample ID and/or a range of Sample IDs, or by Rack and Position. (Refer to Figure 7.19.) E010267S.EPS Figure 7.19 Rerun Samples Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-61...
  • Page 322 Sample IDs field, separated by a comma. all Sample IDs, "0" in the Range field. Press [Enter]. Type zzzzzzzzzzzzzzz in the Thru field. Select a button from the bottom of the dialog box. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-62 September 2016...
  • Page 323 If the original sample was programmed to run with a standard dilution, and later you changed the defaulted standard to a non-standard dilution, the sample will be rerun with the standard dilution. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...

  • Page 324: Editing Sample Programs Before Rerunning

    (Refer to "Editing Programs Before Rerun," Step 3.) This option can be useful when the original sample program had several chemistries selected, and only one or two chemistries are to be rerun. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-64 September 2016...
  • Page 325 Then select the desired chemistry(s) to be rerun. Select Save/Next [F10] to: edit the next sample. return to the Sample Program screen when all samples selected for rerun are edited. E010304S.EPS Figure 7.20 Rerun-Edit Samples Screen IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-65...

  • Page 326: Rerunning Original Sample Programs

    (Refer to Rerunning a Sample, Selecting Samples to be Rerun in this section for more information.) Select Rerun Samples. The Rerun Samples dialog box will close and the Program Sample screen will appear. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-66 September 2016...

  • Page 327: Rerunning Selected Chemistries

    Select <OK> to run the chemistry(s). Select <Cancel> to return to the Program Sample screen without rerunning. E010268S.EPS Figure 7.21 Rerun Chem Dialog Box IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-67...

  • Page 328: Rerunning Controls

    Place the sample on the sample carousel. Select Run from the main menu. Select <OK> in the Check Dilution Segments dialog box to start the run. Select <Cancel> to exit without starting the run. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-68 September 2016...

  • Page 329: Requesting A Load List Or Post-Run Summary

    A Post-run Summary contains the following information for each sample: • Rack/Position • Sample ID • Date and time programmed • Pending tests • Test status • Reason for each incomplete test IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-69...

  • Page 330: Requesting A Load List

    • Rack/Position • Date/Time • Sample Status When a Load List is requested, it can be displayed and/or printed. (Refer to Figure 7.22.) E010264S.EPS Figure 7.22 Load List Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-70 September 2016...
  • Page 331 Sample IDs field, separated by a comma. all Sample IDs, "0" in the Range field. Press [Enter]. Type zzzzzzzzzzzzzzz in the Thru field. Select a button from the bottom of the dialog box. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-71...
  • Page 332 • All positions on each rack are number is entered, automatically selected. • The Pos(s) field cannot be accessed. Select a button from the bottom of the dialog box. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-72 September 2016...
  • Page 333 Select Load List [F9] from the Program Sample screen. Select the options button <▼> beside the Status field. Type the number of the desired status. Select the number beside the desired status. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-73...
  • Page 334 A displayed Load List can also be printed from the Load List screen by selecting Print [F10]. E010265S.EPS Figure 7.23 Load List Screen Additional Information Refer to CHAPTER 5, System Setup, Date and Time Setup for more information on defining date and time formats. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-74 September 2016...

  • Page 335: Requesting A Post-Run Summary

    Select an icon from the menu bar to exit the screen. Setting the Post Run Summary Time Limit Refer to CHAPTER 5, System Setup, Default Setup, "Setting the Default Post Run Summary Time Search." IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-75...

  • Page 336: Clearing A Sample

    • the associated Position on the Rack becomes available for programming. • the Sample ID cannot be reused. • the sample program cannot be recalled by Rack and Position. E010266S.EPS Figure 7.24 Clear Samples Dialog Box Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-76 September 2016...

  • Page 337: Clearing A Sample By Sample Id

    Select <OK> again to confirm the Sample IDs or <Cancel> to return to the Clear Samples dialog box. Select <Cancel> to return to the Program Sample screen without clearing samples. IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-77...

  • Page 338: Clearing A Sample By Rack And Position

    Select <OK> again to confirm the Racks and Positions or <Cancel> to return to the Clear Samples dialog box. Select <Cancel> to return to the Program Sample screen without clearing samples. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-78 September 2016...

  • Page 339: Routine Operation

    Bar Code Setup and Host Communications Setup should first be appropriately defined. (Refer to CHAPTER 5, System Setup.) Operating in Host Query Mode Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using host query. Step...
  • Page 340 Select Main from the menu bar. Select Run. Select <OK> in the Check Dilution Segments dialog box to start the run. Select <Cancel> to exit without starting the run. (2 of 2) Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-80 September 2016...
  • Page 341 Overview Operating in Bi-directional Mode Operating in Bi-directional Mode Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using bi-directional mode. Step Action Check and clear as necessary: • sample racks Check, clear, and replace as necessary: •...
  • Page 342 Overview Operating Without Host Communications Operating Without Host Communications Follow the steps below for routine operation of the IMMAGE 800 Immunochemistry System using unidirectional mode. Step Action Check and clear as necessary: • sample racks Check, clear, and replace as necessary: •...

  • Page 343: Host Communication Status

    IMMAGE 800 host communications is set for no host. Unidirectional Host Up IMMAGE 800 host communications is set for transfer of data from the IMMAGE 800 to the host only. Bidirectional Host Up IMMAGE 800 is able to communicate with the host.

  • Page 344: Operating Immage 800 In Japanese

    Operating IMMAGE 800 in Japanese Overview Introduction There are several features available when the IMMAGE 800 is enabled in the Japanese language. These features are: • Keyboard entry mode selection in English or Japanese (Romaji) by use of a Japanese keyboard.

  • Page 345: Computer

    Computer The Japanese Keyboard Figure 7.25 depicts the IBM Japanese terminology translation keyboard used with the IMMAGE 800. The function of the normal keyboard keys (For example, [Esc], [Page Up/Down], [Delete], [Tab]) remain the same. E015150L.EPS 1. One Byte (Half-width)/Two Byte (Full-width) 4.
  • Page 346 • To return to Hiragana, press the [Katakana/Hiragana] key. • The [one byte/two byte] key is used as a toggle to switch between half-width and full-width characters. Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-86 September 2016...

  • Page 347: Data/Text Entry

    The screens and fields available for text entry of Japanese characters are: Main Sample Program Screen (Refer to Figure 7.26.) • Sample Comment J015148S.EPS Figure 7.26 Sample Programming Screen IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-87...
  • Page 348 Patient Demographic Screen MI= Middle Initial. It is recommended that the MI field be disabled in the demographics screen setup (Refer to Chapter 5, System Setup) when running the IMMAGE 800 in the Japanese language mode. Sample Programming IMMAGE 800 Operations Manual A11403...
  • Page 349 Sample Comments Screen MI= Middle Initial. It is recommended that the MI field be disabled in the demographics screen setup (Refer to Chapter 5, System Setup) when running the IMMAGE 800 in the Japanese language mode. IMMAGE 800 Operations Manual A11403...
  • Page 350 Data/Text Entry Screens and Fields Report Setup Screen (Refer to Figure 7.30) • Facility Name • Facility Address • Attention Person Figure 7.30 Report Setup Screen Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-90 September 2016...

  • Page 351: Language Conversions

    Note: There can be one (1), or over one hundred (100), Kanji candidates, on a case by case basis. The maximum number of Kanji choices displayed at any time is nine (9). IMMAGE 800 Operations Manual A11403 Sample Programming September 2016...
  • Page 352 • To view the previous set of Kanji candidates, press the up ( ↑ ) arrow key. • The last Kanji character used always appears as candidate number one, until the IMMAGE 800 system is rebooted. • The number of Kanji choices found is displayed to the right of the Kanji choices displayed, and the number associated with the numeric order is displayed to the left of the Kanji choices.

  • Page 353: Display Language

    Reports and Summaries are displayable and printable in mixed scripts of Japanese and English characters. These include, but are not limited to: • Calibration- Reports and Load Lists • Post-Run Summary • Sample Load List • Results Recall IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-93...
  • Page 354 Display Language Data Storage/Retrieval Data Storage/Retrieval The IMMAGE 800 system has the capability of retrieving samples and results by patient names, in Japanese. Data entered in Japanese is stored and retrieved in the Japanese language mode. Databases stored/archived in Japanese are not displayable with Japanese characters in other languages.

  • Page 355: Host Communication Interface

    Japanese Character Transfer Special provisions are necessary to accommodate the transfer of Japanese characters over the customer communication network. The baseline IMMAGE 800 host communication protocol uses the specifications of ASTM E1381-91. The optimal use of escape delimiters is implemented to allow sending and receiving of Japanese characters.
  • Page 356 Host Communication Interface Hiragana Conversions From Romaji Hiragana Conversions From Romaji J015152L.EPS Figure 7.32 Hiragana Conversions From Romaji Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-96 September 2016...
  • Page 357 Host Communication Interface Katakana Conversions From Romaji Katakana Conversions From Romaji J015153L.EPS Figure 7.33 Katakana Conversions From Romaji IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7-97...
  • Page 358 Host Communication Interface Katakana Conversions From Romaji Sample Programming IMMAGE 800 Operations Manual A11403 Page 7-98 September 2016...

  • Page 359: Chapter 8 Results Recall

    Recalling Results by Patient Name ..................8-8 Recalling Results by Run Date/Time ..................8-9 Displaying Recalled Results on the Screen ................8-11 Printing Recalled Results ...................... 8-12 Sending Results to the Host ....................8-13 IMMAGE 800 Operations Manual A11403 Results Recall September 2016 Page 8-1...

  • Page 360: Results Recall

    ID, rack and position, patient ID, or run date and time. Results which have been recalled can be sent to a host computer. Up to 10,000 patient samples may be stored by the IMMAGE 800 database. Results Recall...

  • Page 361: Recalling Results By Sample Id

    Sample IDs, "0" in the Range field. Press [Enter]. Type zzzzzzzzzzzzzzz in the Thru field. Select the options button <▼> beside the Data Source field. (1 of 2) IMMAGE 800 Operations Manual A11403 Results Recall September 2016 Page 8-3...
  • Page 362 Refer to Displaying Recalled Results on the Screen and Printing a Recalled Result in this chapter to display or print results. (2 of 2) E014099S.EPS Figure 8.1 Recall Results Screen Results Recall IMMAGE 800 Operations Manual A11403 Page 8-4 September 2016...

  • Page 363: Recalling Results By Rack And Position

    NOTICE Patient results restored from diskettes cannot be sent to the host. Select a function button from the bottom of the screen. (1 of 2) IMMAGE 800 Operations Manual A11403 Results Recall September 2016 Page 8-5...
  • Page 364 Recalling by Rack and Position Step Action , continued Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results. (2 of 2) Results Recall IMMAGE 800 Operations Manual A11403 Page 8-6 September 2016...

  • Page 365: Recalling Results By Patient Id

    Select a function button from the bottom of the screen. Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results. IMMAGE 800 Operations Manual A11403 Results Recall September 2016 Page 8-7...

  • Page 366: Recalling Results By Patient Name

    Select a function button from the bottom of the screen. Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results. Results Recall IMMAGE 800 Operations Manual A11403 Page 8-8 September 2016...

  • Page 367: Recalling Results By Run Date/Time

    Patient results restored from diskettes cannot be sent to the host. Refer to Displaying Recalled Results on the Screen and Printing a Recalled Result in this chapter to display or print results. IMMAGE 800 Operations Manual A11403 Results Recall September 2016...
  • Page 368 Time: hh: 0-23 Setup. From and To mm: 0-59 • The 12-hour default is AM. (24-hour format) Additional Information Refer to CHAPTER 5, System Setup, Date and Time Setup. Results Recall IMMAGE 800 Operations Manual A11403 Page 8-10 September 2016...

  • Page 369: Displaying Recalled Results On The Screen

    Each sample generates at least two report pages. Select Prev Sample [F9] or Next Sample [F10] to view other samples if more than one sample result was recalled. E010286S.EPS Figure 8.2 Results Screen IMMAGE 800 Operations Manual A11403 Results Recall September 2016 Page 8-11...

  • Page 370: Printing Recalled Results

    Additional Information For information on the default report format setup refer to CHAPTER 5, System Setup, Report Setup. For examples of result report formats, refer to APPENDIX B, Reports. Results Recall IMMAGE 800 Operations Manual A11403 Page 8-12 September 2016...

  • Page 371: Sending Results To The Host

    Sending Results to the Host Introduction Results from the IMMAGE 800 are automatically sent to the host computer when the autosend is enabled in Host Communications setup. Results can be sent manually to the host computer whether autosend is enabled or disabled.
  • Page 372 Sending Results to the Host Additional Information Results Recall IMMAGE 800 Operations Manual A11403 Page 8-14 September 2016...

  • Page 373: Chapter 9 Quality Control

    Displaying the QC File List ....................9-20 QC Log ..........................9-22 Displaying QC Summaries ....................9-27 QC Chart (Levey-Jennings) ....................9-29 QC Backup ..........................9-31 Restoring and Reviewing Backup Data ................9-34 IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-1...

  • Page 374: Quality Control

    • Print Control Recommended QC and Analysis Intervals Beckman Coulter recommends that at least two levels of control material be analyzed daily. In addition, these controls should be run with each new calibration, with each new lot of reagent, and run after specific maintenance or troubleshooting, as detailed in CHAPTER 10, Utilities.

  • Page 375: Qc Statistics And Rules

    Results are flagged at time of run. Flagging is not changed if the operator modifies the assigned mean and/or SD. If the operator chooses to use a QC program other than the IMMAGE 800 QC program, assigning a mean of "0" and an SD of "99999" for a chemistry prevents additional flagging of the results in the IMMAGE 800 QC database and on the IMMAGE 800 screen.
  • Page 376 Additional QC Precision Rules Some additional Westgard QC rules are helpful when determining whether the system is in control. These are not flagged by the IMMAGE 800 QC program but can help in determining system performance. (Refer to Figure 9.1.) •...
  • Page 377 Control ACCEPT/REJECT CHART Data IN CONTROL ACCEPT RUN OUT - OF - CONTROL REJECT RUN EVALUATE E015001L.EPS Figure 9.1 QC Accept/Reject Chart Using Westgard Rules IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-5...

  • Page 378: Defining A Control

    The mean and SD values may be edited, as data is collected for the individual laboratory. Each laboratory should establish its own precision parameters which more accurately reflect individual laboratory quality control criteria. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-6 September 2016...
  • Page 379 Press [Enter] to accept the Auto-increment QC File number. Enter a unique file number beside each of the chemistries being defined in the QC File Number field (up to 3 numeric characters). (1 of 2) IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-7...
  • Page 380 <2> Delete undefined file(s) delete the chemistries in question from this control from the control. <Cancel> to return to the Define/Edit screen and enter the mean and/or SD. (2 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-8 September 2016...
  • Page 381 Defining a Control Entering the Minimum Control Definition E014029S.EPS Figure 9.2 Quality Control Screen E014031S.EPS Figure 9.3 Define/Edit Controls Screen IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-9...
  • Page 382 • Control IDs, unlike Sample IDs, can be reused without being cleared, after the control sample is run. • Results from all Control IDs for a chemistry are collected under the same Control Name. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-10 September 2016...
  • Page 383 Select any icon from the menu bar to exit the Define/Edit Controls screen and save the control definition. IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-11...

  • Page 384: Editing A Control

    Step Action From the Quality Control screen select the button beside the control name to be edited. Select Define/Edit [F2]. (Refer to Figure 9.3.) (1 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-12 September 2016...
  • Page 385 Select <Cancel> to return to the Define/Edit Controls screen without saving the Control ID. Select any icon from the menu bar to exit the Define/Edit Controls screen and save the edited control definition. (2 of 2) IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-13...
  • Page 386 Add the chemistry back into the control definition. (Refer to "Adding or Deleting Individual Chemistries.") Redefine the chemistry. (Refer to "Entering the Minimum Control Definition" or "Defining More Information for a Control.") Quality Control IMMAGE 800 Operations Manual A11403 Page 9-14 September 2016...
  • Page 387 Editing a Control Additional Information Additional Information Refer to CHAPTER 5, System Setup, Report Setup for information on setting up a report format for surveys. IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-15...

  • Page 388: Reviewing A Control Definition

    QC file number, and constituent code. Select any icon from the menu bar to exit the Review Controls screen. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-16 September 2016...
  • Page 389 Reviewing a Control Definition Reviewing, Deleting, and Printing a Control Definition E014033S.EPS Figure 9.5 Review Controls Screen IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-17...

  • Page 390: Deleting A Control Definition

    Select Review Control [F1]. Select Delete Control [F3]. Select <OK> to delete the control. Select <Cancel> to return to the Quality Control screen without deleting the control. (1 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-18 September 2016...
  • Page 391 Select <OK> to delete the control. Select <Cancel> to return to the Quality Control screen without deleting the control. Enter a maximum of three alphanumeric characters in the Operator ID field. Press [Enter]. IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-19...

  • Page 392: Displaying The Qc File List

    QC List. List All Chem [F4] Chemistry name in alphabetical order Select Print [F10] to print the File List. Select any icon from the menu bar to exit. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-20 September 2016...
  • Page 393 Displaying the QC File List Displaying QC File Lists E014034S.EPS Figure 9.6 QC File List IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-21...

  • Page 394: Qc Log

    QC Chart, but is not used to calculate statistics. Deleted QC data point was deleted. The date, time and operator are displayed beside the deletion. An Action Log comment is associated with the data point. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-22 September 2016...
  • Page 395 Select <OK> to continue. Data is displayed by chemistry with reagent lot listed in descending order. (Use the <Page Up>/<Page Down> buttons to access additional data.) Select <Cancel> to exit. To print the QC Log select Print [F10]. IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-23...
  • Page 396 Select the result by selecting the check box next to the result. Select Delete Result [F3]. Enter a maximum of 3 alphanumeric characters in the Operator ID field. Press [Enter]. (1 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-24 September 2016...
  • Page 397 The QC Action Log dialog box appears. Enter a maximum of 30 alphanumeric characters in the Comment field. Select <OK> to save the comment in the database. Select <Cancel> to exit without saving the comment. (1 of 2) IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-25...
  • Page 398 QC Log Action Log Step Action , continued Select Print [F10] to print the QC Log. (2 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-26 September 2016...

  • Page 399: Displaying Qc Summaries

    (N) for any control within a specified date interval. The printed report contains the cumulative mean, SD, CV and Number of accumulated results. A report can be printed in the Inter-Lab format for submission to Beckman Coulter. The constituent code must be defined in order for a chemistry to be included in the Inter-Lab QC Summary.
  • Page 400 Displaying QC Summaries Additional information E014038S.EPS Figure 9.8 QC Summary Quality Control IMMAGE 800 Operations Manual A11403 Page 9-28 September 2016...

  • Page 401: Qc Chart (Levey-Jennings)

    Select <OK> to display the QC Chart(s) Select <Cancel> to cancel the Chart request. Select the <Page Up>/<Page Down> buttons to access all requested QC charts. (1 of 2) IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-29...
  • Page 402 QC File# [F2] specify other File Numbers for charting. Print [F10] print a copy of the QC Chart(s). (2 of 2) E014039S.EPS Figure 9.9 QC Chart Quality Control IMMAGE 800 Operations Manual A11403 Page 9-30 September 2016...

  • Page 403: Qc Backup

    The cumulative statistics are not affected by this deletion. Why Perform Routine QC Backup The IMMAGE 800 database can store up to 35,000 QC results from 999 QC files. Upon exceeding 999 QC Files, a pop-up window appears notifying the operator that the QC database is full.
  • Page 404 Select <OK> to delete the QC results from the hard disk. Select <Cancel> to return to the Quality Control screen without deleting the QC results from the hard disk. Quality Control IMMAGE 800 Operations Manual A11403 Page 9-32 September 2016...
  • Page 405 QC Backup QC Backup E014040S.EPS Figure 9.10 QC Backup Dialog Box IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-33...

  • Page 406: Restoring And Reviewing Backup Data

    Select <OK> on the Backup/Restore screen to view the QC database. Select <Cancel> to exit without viewing the database. Select <OK> when the database is successfully restored. (1 of 2) Quality Control IMMAGE 800 Operations Manual A11403 Page 9-34 September 2016...
  • Page 407 (Refer to "Accessing QC Chart" in this chapter.) Print Control [F10] print backed up control ranges. (2 of 2) E014041S.EPS Figure 9.11 QC Source Dialog Box IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9-35...
  • Page 408 Restoring and Reviewing Backup Data Reviewing Archived Data Quality Control IMMAGE 800 Operations Manual A11403 Page 9-36 September 2016...

  • Page 409: Chapter 10 Utilities

    Calibrate Touch Screen ....................... 10-67 Replacing Parts/User Servicing ....................10-69 Overview ..........................10-69 Syringe ..........................10-70 Sample and Reagent Crane Mixer/Paddle ................10-71 Sample and Reagent Crane Probe ..................10-72 IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-1...

  • Page 410: Utilities

    This section explains how to use: • Error messages for troubleshooting • Event Log • Callable Diagnostics • alignment • backup/restore • internal wash bottle fill • touch screen calibration Utilities IMMAGE 800 Operations Manual A11403 Page 10-2 September 2016...
  • Page 411 Replacing Parts/ User Servicing Replacing Parts/ User Servicing For help with any system issues, call Beckman Coulter Clinical Support. The following information will assist the troubleshooting process: the model number, part number or serial number of the affected system and diagnostic printouts containing full details of the difficulty encountered.

  • Page 412: Maintenance

    Recommended Tools and Supplies Beckman Coulter Tools and Supplies Maintenance Recommended Tools and Supplies Beckman Coulter Tools and Supplies The following items can be acquired from Beckman Coulter, Inc. Table 10.1 Beckman Coulter Tools and Supplies Item Part Number Maintenance Logbook...

  • Page 413: Maintenance Precautions

    Introduction Maintenance Precautions Introduction To ensure the safe operation of the IMMAGE 800, and the safety of the operator, please follow the precautions listed below. Precautions 1. Do not remove or install a circuit board, connect or disconnect any plug or cable while the power cord is connected.

  • Page 414: Maintenance Schedule

    Introduction Follow the schedule of auto, daily, monthly, and as-indicated maintenance to keep the IMMAGE 800 in proper operating condition. For higher volume laboratories, maintenance frequency, when appropriate, will be indicated based on the number of tests. To keep a log of performed maintenance, use the IMMAGE Immunochemistry Systems Maintenance Logbook.

  • Page 415: Auto Maintenance Procedures

    12 hours. If the system is active when one of the above situations occur, or the system is interrupted during the Auto Maintenance cycle, the wash will run again in one hour. IMMAGE 800 Operations Manual A11403 Utilities September 2016...

  • Page 416: Daily Maintenance Procedures

    Daily Maintenance Procedures Daily Daily Maintenance Procedures Daily The following table lists the scheduled daily maintenance for the IMMAGE 800 System. Table 10.2 Daily Maintenance Check Clean Wash Volume and Tubings Reagent and Sample Probes/Mixers Waste Volume and Tubing Fluid spills...
  • Page 417 If... then... fluid spills are present cover spills with 10% bleach solution and wipe with an at location (1), absorbent towel. (Call Beckman Coulter Clinical Support.) (2), or (3) (Refer to Figure 10.2) Figure 10.2 (1 of 2) IMMAGE 800 Operations Manual A11403...
  • Page 418 The instrument status must be in Standby in order to proceed with the steps below to clean the reagent/sample probes and mixer paddles. Step Action Raise reagent/sample crane probe covers as shown. Figure 10.4 (1 of 2) Utilities IMMAGE 800 Operations Manual A11403 Page 10-10 September 2016...
  • Page 419 Select Utilities from the menu bar. Select <1> Prime from the Utilities dialog box. Type 1 in the Option No. field and press [Enter]. Enter number of primes desired. Select <OK>. IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-11...

  • Page 420: Monthly Maintenance Procedures

    Monthly Maintenance Procedures Monthly Monthly Maintenance Procedures Monthly The following table lists the scheduled monthly maintenance for the IMMAGE 800 System. Table 10.3 Monthly Maintenance Clean Perform Exterior surfaces Record the cycle count. Fan Filters Cleaning Surfaces Wipe all exposed surfaces on the system and table surfaces with a fresh 10% bleach solution.
  • Page 421 (2 of 2) Cycle Count The cycle count is the total number of tests started by the IMMAGE 800. Obtaining the cycle count is necessary to determine the number of tests performed. Follow the steps below to obtain the cycle count.

  • Page 422: As-Indicated Maintenance

    As-Indicated Maintenance As-Indicated As-Indicated Maintenance As-Indicated The following table lists the As-Indicated maintenance for the IMMAGE 800 System. Table 10.4 As-Indicated Maintenance Clean Perform Clean or replace printer cartridge Replace all Cuvettes every 10,000 tests. (Refer to Printer Manual.) For systems using DIL2, cuvettes may need to be replaced more frequently.
  • Page 423 As-Indicated Maintenance Decontaminating Carousels and Racks Step Action To remove the reagent carousel, lift the reagent cover (1). Figure 10.8 Pull up on the carousel (1). Figure 10.9 (1 of 2) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-15...
  • Page 424 Observe rack labels for bubbling, peeling, or fading. Remove and replace with a new label if necessary according to instructions in CHAPTER 5, System Setup, Placing Bar Code Label on Rack (2 of 2) Utilities IMMAGE 800 Operations Manual A11403 Page 10-16 September 2016...
  • Page 425 Remove the two reaction module cover screws (1). Figure 10.12 Slide reaction module cover forward from under cuvette wash station as shown. Figure 10.13 (1 of 3) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-17...
  • Page 426 Enter 7 in the Option No. field and press [Enter]. Type the first cuvette number (1) to begin the wash in the Starting Range field and press [Enter]. (2 of 3) Utilities IMMAGE 800 Operations Manual A11403 Page 10-18 September 2016...
  • Page 427 Select <3> Diagnostics. Select <2> Callable Diagnostics. Select <1> Electro-mechanical motion. Select Home All [F3]. Select Devices [F2]. Select either <11> Sample syringe or <12> Reagent syringe. (1 of 2) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-19...
  • Page 428 After the status returns to Standby, prime the system and observe syringes for leaks or bubbles. Refer to Daily Maintenance Procedures, "Priming," in this chapter. Run controls to verify system performance. (2 of 2) Utilities IMMAGE 800 Operations Manual A11403 Page 10-20 September 2016...

  • Page 429: Troubleshooting

    • Error messages without a prefix are displayed as pop-up windows (e.g., 10). The "Action" column is prioritized with the most likely solutions appearing first. Call Beckman Coulter Clinical Support as a final resolution. NOTICE The Status Monitor screen updates every three seconds with out-of-range results highlighted in red and should, therefore, be observed for several minutes to verify proper instrument performance.
  • Page 430 Rgts/Cal screen. Chk Optics Optics Error for AGXS, CALL BECKMAN COULTER excessive Q Values CLINICAL SUPPORT Code Segment FATAL: CALL BECKMAN COULTER CRC Failure CLINICAL SUPPORT (1 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-22 September 2016...
  • Page 431 P12V PS OR P12V Power Supply Out CALL BECKMAN COULTER of Range CLINICAL SUPPORT N12V PS OR N12V Power Supply Out CALL BECKMAN COULTER of Range CLINICAL SUPPORT (2 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-23...
  • Page 432 2. Observe that reagent probe enters buffer. 3. Rerun sample. Dil LVL Level Sense Failure on 1. Check and remove bubbles from Diluent diluent. 2. Rerun sample. (3 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-24 September 2016...
  • Page 433 Excessive Scatter CALL BECKMAN COULTER CLINICAL SUPPORT Blank Term Assoc. Blank Terminated CALL BECKMAN COULTER CLINICAL SUPPORT S/W Error Bad Test Object Address CALL BECKMAN COULTER CLINICAL SUPPORT Uncal RGT Uncalibrated Reagent Recalibrate reagent. DilWell Err Dilution Segments not 1. Clear dilution segments.
  • Page 434 ORLO No Reaction (excluding Refer to IMMAGE Immunochemistry Drugs) Systems, Chemistry Information Manual for appropriate measuring range. RXN Error No Reaction (Drugs) CALL BECKMAN COULTER CLINICAL SUPPORT (5 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-26 September 2016...
  • Page 435 DilWell LVL Level sense failure on a Rerun sample. dilution well S/W Error No memory available Reboot Instrument. Bad Data Bad Data CALL BECKMAN COULTER CLINICAL SUPPORT (6 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-27...
  • Page 436 Queue Ident FATAL: CALL BECKMAN COULTER Error CLINICAL SUPPORT Segment Get FATAL: CALL BECKMAN COULTER Error CLINICAL SUPPORT Partition Create FATAL: CALL BECKMAN COULTER Error CLINICAL SUPPORT (7 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-28 September 2016...
  • Page 437 Reagent A at 2. Rerun sample. Position Level Sense WARNING: 1. Check and remove bubbles from Failure on Reagent Compartment B. Reagent B at 2. Rerun sample. Position (8 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-29...
  • Page 438 CALL BECKMAN COULTER False Trigger at CLINICAL SUPPORT Sample Rack Software FATAL: CALL BECKMAN COULTER Initialization CLINICAL SUPPORT Error Error FATAL: CALL BECKMAN COULTER Downloading CLINICAL SUPPORT (9 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-30 September 2016...
  • Page 439 CLINICAL SUPPORT 1203 Start cycle does FATAL: CALL BECKMAN COULTER not match current CLINICAL SUPPORT cycle 1204 Invalid Next Test FATAL: CALL BECKMAN COULTER Status CLINICAL SUPPORT (10 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-31...
  • Page 440 Wash is Out of Range 1217 Preferred Wash FATAL: CALL BECKMAN COULTER Selection Error CLINICAL SUPPORT 1218 Bad Return FATAL: CALL BECKMAN COULTER Status for CLINICAL SUPPORT Preferred Wash (11 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-32 September 2016...
  • Page 441 WARNING: Will STOP CALL BECKMAN COULTER Lpia Offset CLINICAL SUPPORT Quality High 1607 Optics Check- WARNING: Will STOP CALL BECKMAN COULTER Lpia Range CLINICAL SUPPORT Quality High (12 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-33...
  • Page 442 CLINICAL SUPPORT 1617 Cannot Start Run WARNING: Verify that volume in external wash - Internal Wash solution container is sufficient. Bottle is Empty CALL BECKMAN COULTER CLINICAL SUPPORT (13 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-34 September 2016...
  • Page 443 Not Loaded 1629 File Gets Error: WARNING: CALL BECKMAN COULTER CLINICAL SUPPORT 1630 Download Error: WARNING: CALL BECKMAN COULTER UDS File CLINICAL SUPPORT Exceeded Limit of 1024 Lines (14 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-35...
  • Page 444 CALL BECKMAN COULTER Tree Address CLINICAL SUPPORT 2202 Scheduler Fatal FATAL: CALL BECKMAN COULTER Error CLINICAL SUPPORT 2204 Corrupt Cycle FATAL: CALL BECKMAN COULTER Stack CLINICAL SUPPORT (15 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-36 September 2016...
  • Page 445 TDB Fatal Error FATAL: CALL BECKMAN COULTER CLINICAL SUPPORT 2221 Failed to WARNING: 1. Verify all constituents (reagents, Schedule Test samples, buffers, diluents, and segments) are available. 2. Rerun sample. (16 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-37...
  • Page 446 3. Check Status Monitor for stable reaction chamber reagent compartment temperature in acceptable range. 2408 Analog Ground WARNING: Observe Status Monitor Out of Range (17 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-38 September 2016...
  • Page 447 24 Volt Power WARNING: Observe Status Monitor Supply ‘D’ Out of Range High 2424 24 Volt Power WARNING: Observe Status Monitor Supply ‘E’ Out of Range Low (18 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-39...
  • Page 448 2. Verify low pressure is in range. 2436 Vacuum Out of WARNING: With system running samples: Range Low 1. Check Status Monitor. 2. Verify vacuum is in range. (19 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-40 September 2016...
  • Page 449 Monitor message to Console 2800 SS Semaphore FATAL: CALL BECKMAN COULTER Create Error CLINICAL SUPPORT 2801 Test Object FATAL: CALL BECKMAN COULTER Pointer and Tog CLINICAL SUPPORT Mismatch (20 of 21) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-41...
  • Page 450 Table 10.6 Displayed or Printed Error Messages , continued Error # Abbreviation/ Explanation Action Message 2802 Invalid Reagent FATAL: CALL BECKMAN COULTER Type from CLINICAL SUPPORT Reagent Handler (21 of 21) Utilities IMMAGE 800 Operations Manual A11403 Page 10-42 September 2016...

  • Page 451: Event Log

    It may be useful to select a specific time period for retrieval. This may be done before or after selecting the event option number. Refer to Date/Time option instructions. (1 of 2) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-43...
  • Page 452 For removing unwanted event information. Print [F10] For creating a paper copy. To save paper, before selecting Print, verify only the desired event option(s) for the appropriate time period selected. Utilities IMMAGE 800 Operations Manual A11403 Page 10-44 September 2016...
  • Page 453 To transfer information to diskette select <Copy to Disk> from the Display Events dialog box and follow the steps under "Copying to disk." To print the information, select <Print>. If finished viewing displayed information, select <Close>. IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-45...
  • Page 454 Type the appropriate drive option and press [Enter]. (Refer to Figure 10.20.) Insert disk into appropriate drive. Select <OK> to transfer information to a diskette. Select <Cancel> to return to the Event Log Screen without copying the information. Utilities IMMAGE 800 Operations Manual A11403 Page 10-46 September 2016...
  • Page 455 [F1] to view events that occurred during the selected time period. (Refer to Figure 10.21.) Select <Cancel> to exit the Date/Time screen without specifying a date/ time period. E010296S.EPS Figure 10.21 Date/Time Dialog Box IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-47...
  • Page 456 Printing an Event Log Follow the steps below to print an Event Log. Step Action Select a desired event from the Event Log Screen. Select Display Events [F1]. Select <Print>. Utilities IMMAGE 800 Operations Manual A11403 Page 10-48 September 2016...

  • Page 457: Callable Diagnostics

    Callable Diagnostics Introduction Callable Diagnostics Introduction The Callable Diagnostics option provides procedures directed toward identifying and isolating specific IMMAGE 800 malfunctions. This section describes: • Home All • Disable All • Sample Stir Motor • Reagent Stir Motor The instrument status must be in Standby in order to proceed with the procedures described below.
  • Page 458 Select <3> Diagnostics from the Utilities screen. Enter 3 in the Option No. field. Select <2> Callable Diagnostics from the Diagnostics dialog box. Enter 2 in the Option No. field and press [Enter]. (1 of 2) Utilities IMMAGE 800 Operations Manual A11403 Page 10-50 September 2016...
  • Page 459 Servicing, Sample and Reagent Crane Mixer/Paddle in this chapter.) Verify that the Speed of Motor displayed at the end of the motor exercise is within 6000 to 10000 Revolutions per minute. Call Beckman Coulter Clinical Support if the "Revolutions per minute" is out of specifications. Select…...

  • Page 460: Alignment

    Beckman Coulter Field Service office for assistance. Prerequisite Alignment Steps Prerequisite steps are noted on the IMMAGE 800 alignment screens as Step 1 for each alignment procedure. These prerequisites are required when aligning a new system or realigning an entire system. The prerequisites can be ignored when performing an alignment of a specific functional area.
  • Page 461 "Straightness of Sample and/ Mixer/Paddle, or Reagent Probe (from the side)." not aligned with the Crane adjust the probe by gently bending it to Mixer/Paddle, align with the Crane Mixer/Paddle. A014072P.EPS Figure 10.23 IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-53...
  • Page 462 Place a piece of tape along the top left edge of the sample top right edge of the reagent carousel tub. (Refer to Figure carousel tub. (Refer to Figure 10.25.) 10.26.) (1 of 6) Utilities IMMAGE 800 Operations Manual A11403 Page 10-54 September 2016...
  • Page 463 Alignment Straightness of the Sample or Reagent Probe (from side) Step Action , continued A011431P.EPS Figure 10.24 A014074P.EPS Figure 10.25 (2 of 6) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-55...
  • Page 464 Loosen the Phillips screws on the right side (2) of the assembly. (Refer to Figure 10.27.) A014076P.EPS Figure 10.27 Rotate the assembly towards the appropriate compartment and raise the probe guard to expose the probes. (3 of 6) Utilities IMMAGE 800 Operations Manual A11403 Page 10-56 September 2016...
  • Page 465 From the side of the instrument, make marks (1) and (2) on the piece of tape where the sides of the probe line up. (Refer to Figure 10.28.) A014077P.EPS Figure 10.28 (4 of 6) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-57...
  • Page 466 Figure 10.30.) not centered between the tape align probe by gently bending it marks, to center of the tape marks. A014079P.EPS Figure 10.30 Reinstall the sample carousel cover. (5 of 6) Utilities IMMAGE 800 Operations Manual A11403 Page 10-58 September 2016...
  • Page 467 Enter 10 in the Area No. field and press [Enter]. 2. Select <1> Reagent Crane Probe from the Alignment dialog box. Enter 1 in the Procedure No. field and press [Enter]. (1 of 2) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-59...
  • Page 468 [F1] Prev Align allows the operator to overwrite this alignment data with the previous alignment data. Select <No> to restore the previous alignment data. (2 of 2) E014080S.EPS Figure 10.31 Alignment Dialog Box Utilities IMMAGE 800 Operations Manual A11403 Page 10-60 September 2016...
  • Page 469 Select <Yes> from the Alignment dialog box to save the new alignment data to the database. [F1] Prev Align allows the operator to overwrite this alignment data with the previous alignment data. Select <No> to restore the previous alignment data. IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-61...
  • Page 470 Select <Yes> from the alignment dialog box to save the new alignment data to the database. [F1] Prev Align allows the system to overwrite this alignment data with the previous alignment data. Select <No> to restore the previous alignment data. Utilities IMMAGE 800 Operations Manual A11403 Page 10-62 September 2016...

  • Page 471: Backup/Restore

    Select <OK> to back up the database. Select <Cancel> to exit and return to the Utilities screen. When Backup is complete, a confirmation is displayed on the screen. (Refer to Figure 10.32.) Select <OK> to exit. IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-63...
  • Page 472 Restore View Patient Copy the View patient results into the Results from the Hard Disk system from the backup hard disk. (1 of 2) Utilities IMMAGE 800 Operations Manual A11403 Page 10-64 September 2016...
  • Page 473 (Refer to Figure 10.33.) Select <OK> to exit. Refer to CHAPTER 8, Results Recall to display and print View patient results. (2 of 2) E014082S.EPS Figure 10.33 Restore Complete Confirmation Dialog Box IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-65...

  • Page 474: Fill Internal Wash Bottle

    Introduction Fill Internal Wash Bottle Introduction The IMMAGE 800 is equipped with an internal wash bottle that supplies wash solution to the system where needed. The internal wash bottle is pressurized and is constantly replenished with wash solution from the Wash Solution Container. When the source runs out of wash solution, it may be necessary to fill the internal wash bottle after replacing the empty Wash Solution Container.

  • Page 475: Calibrate Touch Screen

    Calibrate Touch Screen Introduction The IMMAGE 800 system can access screen components with the optional touch screen monitor. After calibration of the touch screen, software functions can be activated by the touch of a finger or other object. Any icon, button, or field on the screen can be selected by touching the icon, button, or field on the screen.
  • Page 476 Calibrate Touch Screen Calibrating the Touch Screen E014070S.EPS Figure 10.34 Utilities Screen with Touch Screen Option Utilities IMMAGE 800 Operations Manual A11403 Page 10-68 September 2016...

  • Page 477: Replacing Parts/User Servicing

    Introduction Replacing Parts/User Servicing Overview Introduction This section describes the customer-replaceable parts on the IMMAGE 800: • Syringe • Sample and Reagent Crane Mixer/Paddle • Sample and Reagent Crane Probe The instrument status must be in Standby in order to proceed with the parts replacement described below.

  • Page 478: Syringe

    Syringe Replacing Syringes Syringe Replacing Syringes Refer to As-Indicated Maintenance, "Replacing Syringes," in this chapter. Utilities IMMAGE 800 Operations Manual A11403 Page 10-70 September 2016...

  • Page 479: Sample And Reagent Crane Mixer/Paddle

    Install the new mixer/paddle, making sure that it is pushed all the way up and properly seated. Verify the straightness of the mixer/paddle. (Refer to Troubleshooting, Callable Diagnostics, "Sample Stir Motor and Reagent Stir Motor" in this chapter.) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-71...

  • Page 480: Sample And Reagent Crane Probe

    Remove the left access cover (1) of the Crane Assembly by removing the two Phillips screws on the left side. Loosen the Phillips screws on the right side (2) of the assembly. (Refer to Figure 10.36.) A014076P.EPS Figure 10.36 (1 of 6) Utilities IMMAGE 800 Operations Manual A11403 Page 10-72 September 2016...
  • Page 481 Locate the access cover (1) for the probe level sense cable (2) by tracing the cable from the probe. Remove the access cover using a Phillips screwdriver. (Refer to Figure 10.38.) A014084P.EPS Figure 10.38 (2 of 6) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-73...
  • Page 482 Replacing Sample and Reagent Crane Probe Step Action , continued Disconnect the probe level sense cable from the IMMAGE 800 by pulling the connector (1) straight out from the receptacle. (Refer to Figure 10.39.) A014085P.EPS Figure 10.39 Disconnect the RF cable by pulling the connector (1) straight, out from the receptacle.
  • Page 483 RF (radio frequency) shield housing (2) (a brass cylinder). (Refer to Figure 10.41.) A014086P.EPS Figure 10.41 Pull the probe up and out from the crane assembly. (Refer to Figure 10.42.) A012191P.EPS Figure 10.42 (4 of 6) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-75...
  • Page 484 Figure 10.44 Secure the probe by reinstalling the set screw. Connect the tubing from the top of the probe assembly. Connect the level sense cable to the receptacle. (5 of 6) Utilities IMMAGE 800 Operations Manual A11403 Page 10-76 September 2016...
  • Page 485 Prime the system. (Refer to Troubleshooting, Daily Maintenance Procedures, "Priming" in this chapter.) Verify the straightness of the probe. (Refer to Troubleshooting, Alignment, Straightness of the Sample Probe in this chapter.) (6 of 6) IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10-77...
  • Page 486 Sample and Reagent Crane Probe Replacing Sample and Reagent Crane Probe Utilities IMMAGE 800 Operations Manual A11403 Page 10-78 September 2016...

  • Page 487: Chapter 11 System Status/Instrument Commands

    Checking Dilution Segment Status and Clearing Dilution Segments ........11-2 Checking Sample Carousel Status ..................11-4 Checking the Instrument Status Monitor ................11-6 Accessing Instrument Commands ..................11-7 IMMAGE 800 Operations Manual A11403 System Status/Instrument Commands September 2016 Page 11-1...

  • Page 488: System Status/Instrument Commands

    Numbers can be separated by a comma as a series or by a dash as a range. Select the number beside each appropriate segment Select <OK>. not to be cleared Select <Cancel>. System Status/Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11-2 September 2016...
  • Page 489 Place an unused segment in the empty position on the sample carousel. Repeat steps 2-5 until all desired segments are replaced. Additional Information Refer to CHAPTER 7, Sample Programming for more information on Dilution Segments status. IMMAGE 800 Operations Manual A11403 System Status/Instrument Commands September 2016 Page 11-3...

  • Page 490: Checking Sample Carousel Status

    Follow the steps below to access the sample carousel status. Step Action Select Status from the menu bar. Select <2> Sample Carousel Status. (Refer to Figure 11.2.) E010303S.EPS Figure 11.2 Sample Carousel Status Screen System Status/Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11-4 September 2016...
  • Page 491 <blank> Programmed Background bar code Not Programmed Background bar code NO READ Programmed Invalid or no bar code Yes Not Programmed Invalid or no bar code No IMMAGE 800 Operations Manual A11403 System Status/Instrument Commands September 2016 Page 11-5...

  • Page 492: Checking The Instrument Status Monitor

    Select <3> Instrument Status Monitor. (Refer to Figure 11.3.) Verify acceptable status monitor parameters. Parameters which are out of range display in red. E010294S.EPS Figure 11.3 Status Monitor Screen System Status/Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11-6 September 2016...

  • Page 493: Accessing Instrument Commands

    Starts a run. Accessing Instrument Commands Follow the steps below to access the instrument command buttons. Step Action Select Main from the menu bar. Select the desired command. IMMAGE 800 Operations Manual A11403 System Status/Instrument Commands September 2016 Page 11-7...
  • Page 494 (Refer to CHAPTER 10, Utilities, As-Indicated Maintenance, "Washing Cuvettes".) more than 24 hours later should be replaced. (Refer to CHAPTER 10, Utilities, As-Indicated Maintenance, "Replacing Cuvettes".) System Status/Instrument Commands IMMAGE 800 Operations Manual A11403 Page 11-8 September 2016...

  • Page 495: Appendix A Instrument Codes

    IGG. Chemistry Codes The codes for chemistries are shown in the following table. Table A.1 Chemistry Codes Code Chemistry Code Chemistry Code Chemistry IGALC IGMLC LPAX CRPH IMMAGE 800 Operations Manual A11403 Instrument Codes September 2016 Page A-1...
  • Page 496 Condition Codes The codes for conditions are shown in the following table. Table A.2 Condition Codes Condition Code Slope/offset adjustment Calibration re-enabled Reagent expired Simulated result Dilution well reused Instrument Codes IMMAGE 800 Operations Manual A11403 Page A-2 September 2016...

  • Page 497: Appendix B Reports

    Introduction APPENDIX B Reports Introduction Examples of reports that can be generated by the IMMAGE 800 Immunochemistry System are shown on the following pages. The reports are in the order listed in Table B.1 and Figure B.1 through Figure B.25.
  • Page 498 Introduction Patient Chartable Report Patient Chartable Report Figure B.1 Patient Chartable Report Reports IMMAGE 800 Operations Manual A11403 Page B-2 September 2016...
  • Page 499 Introduction Control Report Control Report E014102L.EPS Figure B.2 Control Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-3...
  • Page 500 Introduction Laboratory Report Laboratory Report Figure B.3 Laboratory Report Reports IMMAGE 800 Operations Manual A11403 Page B-4 September 2016...
  • Page 501 Introduction Laboratory Report with Dilutions Laboratory Report with Dilutions Figure B.4 Laboratory Report with Dilutions IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-5...
  • Page 502 Introduction Calibration Load List Calibration Load List Figure B.5 Calibration Load List Reports IMMAGE 800 Operations Manual A11403 Page B-6 September 2016...
  • Page 503 Introduction Calibration Report Calibration Report Figure B.6 Calibration Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-7...
  • Page 504 Introduction Sample Load List Sample Load List Figure B.7 Sample Load List Reports IMMAGE 800 Operations Manual A11403 Page B-8 September 2016...
  • Page 505 Introduction Post-run Summary Post-run Summary E014103L.EPS Figure B.8 Post-run Summary IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-9...
  • Page 506 Introduction Units, Slope and Offset Summary Units, Slope and Offset Summary E011432L.EPS Figure B.9 Units, Slope and Offset Summary Reports IMMAGE 800 Operations Manual A11403 Page B-10 September 2016...
  • Page 507 Introduction Reference Interval and Critical Range Summary Reference Interval and Critical Range Summary E014105L.EPS Figure B.10 Reference Interval and Critical Range Summary IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-11...
  • Page 508 Introduction User-Defined Chemistry Definition Report User-Defined Chemistry Definition Report E011446L.EPS Figure B.11 User-Defined Chemistry Definition Report Reports IMMAGE 800 Operations Manual A11403 Page B-12 September 2016...
  • Page 509 Introduction User-Defined Calibration Results Report User-Defined Calibration Results Report E014065L.EPS Figure B.12 User-Defined Calibration Results Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-13...
  • Page 510 Introduction User-Defined Calibration Report User-Defined Calibration Report E014064L.EPS Figure B.13 User-Defined Calibration Report Reports IMMAGE 800 Operations Manual A11403 Page B-14 September 2016...
  • Page 511 Introduction QC File List by Control Name QC File List by Control Name E014106L.EPS Figure B.14 QC File List by Control Name IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-15...
  • Page 512 Introduction QC File List by QC File Number QC File List by QC File Number E014107L.EPS Figure B.15 QC File List by QC File Number Reports IMMAGE 800 Operations Manual A11403 Page B-16 September 2016...
  • Page 513 Introduction QC File List by Chemistry Name QC File List by Chemistry Name E014108L.EPS Figure B.16 QC File List by Chemistry Name IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-17...
  • Page 514 Introduction QC Log Report QC Log Report E014109L.EPS Figure B.17 QC Log Report Reports IMMAGE 800 Operations Manual A11403 Page B-18 September 2016...
  • Page 515 Introduction QC Log by Reagent Lot QC Log by Reagent Lot E014110L.EPS Figure B.18 QC Log by Reagent Lot IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-19...
  • Page 516 Introduction QC Chart Report QC Chart Report E014111L.EPS Figure B.19 QC Chart Report Reports IMMAGE 800 Operations Manual A11403 Page B-20 September 2016...
  • Page 517 Introduction QC Summary Report QC Summary Report E014112L.EPS Figure B.20 QC Summary Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-21...
  • Page 518 Introduction Inter-Lab QC Summary Report Inter-Lab QC Summary Report E014113L.EPS Figure B.21 Inter-Lab QC Summary Report Reports IMMAGE 800 Operations Manual A11403 Page B-22 September 2016...
  • Page 519 Introduction Event/Error Log Event/Error Log Figure B.22 Event/Error Log IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-23...
  • Page 520 Introduction User-Defined Single-Point Calibration Results User-Defined Single-Point Calibration Results E011443L.EPS Figure B.23 User-Defined Single-Point Calibration Results Reports IMMAGE 800 Operations Manual A11403 Page B-24 September 2016...
  • Page 521 Introduction User-Defined Single-Point Calibration Update Report User-Defined Single-Point Calibration Update Report E011444L.EPS Figure B.24 User-Defined Single-Point Calibration Update Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B-25...
  • Page 522 Introduction Plot Robust Means Data Report Plot Robust Means Data Report E011445L.EPS Figure B.25 Plot Robust Means Data Report Reports IMMAGE 800 Operations Manual A11403 Page B-26 September 2016...
  • Page 523 A standardized computer interface specification following the guidelines from the American Society for Testing and Materials. Bar code card A Beckman Coulter-provided card which is imprinted with bar codes. The card contains either Reagent Parameters or Calibrator Parameters to input lot-specific information into the IMMAGE 800 system.
  • Page 524 An acronym for Complementary Metal Oxide Semiconductor, the components of the computer battery that stores the internal clock and PC configurations. Calculation, Beckman Coulter-defined A calculation formula supplied by Beckman Coulter which is uneditable and undeletable. Callable diagnostics Diagnostic routines initiated by the user from the software.
  • Page 525 A user-defined range consisting of low and high values that are used to flag patient results as "critical low" or "critical high". Cuvette One of the receptacles on the IMMAGE 800 reaction carousel in which sample and reactants are mixed and the reaction is measured. Data Acquisition Software.
  • Page 526 The space that separates two characters in a bar code. Inter-lab A Beckman Coulter QC program. Laboratory information system (LIS) A laboratory host computer that can be interfaced to an IMMAGE 800 System. ™ Microtube A sample tube manufactured by Beckman Coulter which is intended for low-volume samples and can be bar coded.
  • Page 527 Multipage list Multipage list A feature of the IMMAGE 800 interface that lists more than one screen page of information (e.g., chemistries). The multipage list includes Page-Up and Page-Down keys for next-page scrolling. Numeric character 0-9. Offset A value which is added or subtracted following the application of a slope value to a chemistry result.
  • Page 528 One-way communication. Results are communicated from the instrument to the host computer only. Unit category An expression of concentration, such as weight/volume (e.g., mg/dL), mass/volume (e.g., mol/L), and International Units/volume (e.g., IU/mL). Glossary IMMAGE 800 Operations Manual A11403 Page 6 of 6 September 2016...
  • Page 529 Add/del chem control chem ....9-14 Calculations, Beckman Coulter defined ..5-28 Adding samples to an operating instrument ..1-7 Editing variables .
  • Page 530 Decision table ......1-4 Disabling automatic printing Index IMMAGE 800 Operations Manual A11403 Page ii of vii September 2016...
  • Page 531 Day format ......5-44 IMMAGE 800 Instrument ..... . 2-3 Day Month Year .
  • Page 532 Printer cartridge ......10-14 Index IMMAGE 800 Operations Manual A11403 Page iv of vii...
  • Page 533 Reagent bar code card ..... . . 6-5 Incomplete ......11-5 IMMAGE 800 Operations Manual A11403 Index...
  • Page 534 System pause......7-56 Index IMMAGE 800 Operations Manual A11403 Page vi of vii...
  • Page 535 Setting the variables ..... . 7-37 Verifying the cal status of reagent parameters ..6-19 IMMAGE 800 Operations Manual A11403 Index...
  • Page 536 © 2016 Beckman Coulter, Inc. All Rights Reserved...

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