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Quality Control

IMMAGE 800 Operations Manual A11403

Page 9-30

September 2016

Figure 9.9

QC Chart

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Control Chems [F1]

specify other chemistries for charting.

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E014039S.EPS

Summary of Contents for IMMAGE 800

Page 1: ...A11403AE September 2016 Operations Manual IMMAGE 800 Immunochemistry System For In Vitro Diagnostic Use Beckman Coulter Inc 250 S Kraemer Blvd Brea CA 92821 U S A ...

Page 2: ...ademarks are the property of their respective owners Find us on the World Wide Web at www beckmancoulter com Beckman Coulter Eurocenter S A 22 rue Juste Olivier Case Postale 1044 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: ... of 2 Revision History A11403AE September 2016 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 ...

Page 4: ...Revision History IMMAGE 800 Operations Manual A11403 Page 2 of 2 September 2016 ...

Page 5: ...nel invalidates any warranty covering the instrument Any servicing of this equipment that requires removal of any covers can expose parts which involve the risk of electric shock or personal injury Make sure that the power switch is turned OFF and that the instrument is disconnected from the main power source Refer such maintenance to qualified service personnel Electrical Safety To reduce the ris...

Page 6: ...atory policies or procedures which pertain to the handling of these materials The reagents and other chemical preparations used with the system will not normally cause adverse reactions however those persons with sensitive skin should wear protective gloves before attempting to work with reagents and other chemical preparations Do not handle sample or solutions without proper protection Body fluid...

Page 7: ...R 2 System Description 2 1 CHAPTER 3 Theory of Operations 3 1 CHAPTER 4 System Power On Off 4 1 CHAPTER 5 System Setup 5 1 CHAPTER 6 Reagents Calibration 6 1 CHAPTER 7 Sample Programming 7 1 CHAPTER 8 Results Recall 8 1 CHAPTER 9 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 ...

Page 8: ...Table of Contents IMMAGE 800 Operations Manual A11403 Page 2 of 2 September 2016 ...

Page 9: ...eptember 2016 Page 1 1 1 CHAPTER 1 General Information Precautions and Hazards Table of Contents General Information Precautions and Hazards 1 2 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 ...

Page 10: ...lyzer designed for the in vitro quantitation of biological fluid components and therapeutic drugs 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 w...

Page 11: ...ual cues to guide the user in how to respond to printed directions Manual Format Information in this manual is presented in modular units Each unit of information is described by a brief title in the left margin Many units consist of a table which presents a procedure process or description Table 1 1 IMMAGE 800 Conventions Convention Description Icon Buttons Icon buttons are in bold with one lette...

Page 12: ...lumn and the appropriate action for each condition in the right column Example of Procedure Table The following table is an example of a procedure table that contains a decision table Read the decision table as complete sentences using the first heading to introduce the condition and the second heading to introduce the action Step 2 of the table is read To enter individual Sample IDs type the Samp...

Page 13: ...4 3633 For customers outside the USA and Canada Call the nearest Beckman Coulter Field Service Office Responsibility During the Warranty Period The user is responsible for the routine preventive maintenance procedures described in the maintenance section of this manual Repairs arising from failure to perform these maintenance procedures at the indicated time intervals will be made at the user s ex...

Page 14: ...agnetic field Proper Handling of Compact Disks Compact disks CD ROMs require special handling to prevent damage Do not place a CD ROM in direct sunlight or excessive heat or humidity Hold a CD ROM by the edges Replace a CD ROM in its case after use Sample Volumes Sample containers must contain an adequate volume of test specimen to ensure accurate aspiration Refer to the IMMAGE Immunochemistry Sys...

Page 15: ...ERATE THE SYSTEM UNTIL AN ELECTRICAL GROUND IS PROVIDED AND THE POWER CORD IS PROPERLY CONNECTED TO GROUND Emergency Stop Turn the instrument main power switch off if the stop button on the screen is unavailable and the instrument must be stopped immediately Cranes Keep clear of both cranes while the instrument is running Covers Keep all covers and shields in place while the instrument is running ...

Page 16: ...s Observe all laboratory policies or procedures pertaining to the handling of biological samples that may contain pathogens Preservatives Sodium azide preservative may form explosive compounds in metal drain lines See National Institute for Occupational Safety and Health bulletin Explosive Azide Hazards 8 16 76 Incineration of used reagent cartridges may produce toxic fumes Handling of Hazardous S...

Page 17: ...wer Switch ON This symbol is located on the instrument and the UPS main power switches When the portion of the switch that displays this symbol is depressed the instrument is ON Instrument or UPS Power Switch ON Instrument or UPS Power Switch OFF This symbol is also located on the instrument and the UPS main power switches When the portion of the switch that displays this symbol is depressed the i...

Page 18: ...d beside the printer power button A green light indicates the power to the printer is ON Printer Power Switch Connection Between Computer and Mouse This symbol is located beside the connection between the computer and the mouse Computer Mouse Connection Connection Between Computer and Keyboard This symbol is located beside the connection between the computer and the keyboard Computer Keyboard Conn...

Page 19: ...ated beside the connection between the computer and the monitor Computer Monitor Connection High Voltage Electric Shock Risk This symbol indicates high voltage or risk of electric shock High Voltage Electric Shock Risk Read Manual 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 biohazardou...

Page 20: ...ning through which a bar code reading beam emits Do not stare into the laser light beam when cover is open or removed Bar Code Caution Label Sample Wheel Compartment Bar Code Caution Label Reagent Compartment This label is placed inside the Reagent Compartment near the opening through which a bar code reading beam emits Do not stare into the laser light beam when the cover interlock is defeated Ba...

Page 21: ... Certification Label IMMAGE 800 Operations Manual A11403 General Information Precautions and Hazards September 2016 Page 1 13 1 Laser Certification Label This label is located on the right side panel Laser Certification Label ...

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: ...0 Buttons 2 31 Toggle Buttons 2 32 Check Boxes 2 33 Performing Software Functions 2 34 Selecting vs Choosing 2 36 Dialog Boxes 2 37 Deleting Data From a Text Field and Printing Data from a Screen 2 38 Page Up Page Down 2 39 Program Structure 2 40 Sample Programming Overview 2 45 System Specifications and Characteristics 2 46 Instrument Specifications 2 46 Peripheral Devices Specifications 2 49 Sam...

Page 24: ...MMAGE 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 Figure 2 1 The IMMAGE 800 Immunochemistry System 1 Instrument 2 Computer 3 Printer A011408P EPS 1 2 3 ...

Page 25: ...he 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 Figure 2 2 IMMAGE 800 Instrument 1 Reagent Compartment 2 Reagent Crane 3 Reaction Module 4 Sample Carousel 5 Sample Crane 6 Upper Instrument Subsystems A011409P EPS 2 1 4 5 6 3 ...

Page 26: ...m Specifications and Characteristics Temperature and Humidity in this chapter Reaction buffer bottles are placed in the center of the reagent compartment The bottles are maintained at room temperature Refer to Figure 2 3 Figure 2 3 The Reagent Compartment 1 Reagent Compartment Cover 2 Reagent Carousel 3 Reaction Buffer Bottle 4 Reagent Cartridges Compartments A and B 5 Reagent Bar Code Reader 6 Fa...

Page 27: ...eagent Carousel Holds up to 24 reagent cartridges and 4 reaction buffer bottles 3 Reaction Buffer Bottles Contain reaction buffers 4 Bar Coded Reagent Cartridges Contain chemistry specific reagent including where applicable Reagent AGXS antigen excess Solution Co reagent Conjugate Evaporation Caps The cartridges are bar coded to allow for instrument identification of each cartridge 5 Reagent Bar C...

Page 28: ...2 6 September 2016 Reagent Crane Description The reagent crane transfers reagents and buffers from the reagent compartment to the reaction wheel Refer to Figure 2 4 Figure 2 4 Reagent Crane 1 Reagent Probe Mixer 2 Reagent Syringe Pump 3 Reagent Crane Wash Station 4 Reagent Addition Ports ...

Page 29: ...om the reagent compartment and dispenses them into a cuvette on the reaction wheel Reagent Paddle Mixer Mixes the contents of a cuvette after reagent or buffer has been dispensed 2 Reagent Syringe Pump 500 µL Mechanism for accurate reagent and buffer aspiration and delivery through the reagent probe 3 Reagent Crane Wash Station Washes interior and exterior of reagent probe mixer 4 Reagent Addition...

Page 30: ...where the reaction takes place The temperature of the reaction module is maintained at approximately 37 C Refer to Figure 2 5 and System Specifications and Characteristics Temperature and Humidity in this chapter Figure 2 5 Reaction Module 1 Optics 2 Reaction Wheel 3 Cuvette 4 Reference Cuvette 5 Cuvette Wash Station 6 Heat Block Temperature Sensor 7 Status Monitor Temperature Sensor ...

Page 31: ...ins to move individual cuvettes to correct positions for each stage of the analysis 3 Cuvettes Hold the combined reactants The reaction being measured takes place in the clear plastic cuvettes The optics pass light through the cuvette to measure scatter 4 Reference Cuvette Has a known scatter value The instrument measures the scatter from the on board reference cuvette It then adjusts the optics b...

Page 32: ...stem via sample racks All sample cups must be placed on the system using the Sample Cup Holder Kit To ensure sufficient sample aspiration do not place sample cups directly into the racks or use 1 0 mL sample cups Sample dilutions are made in dilution wells Refer to Figure 2 6 Figure 2 6 Sample Carousel 1 Sample Carousel Cover 2 Sample Diluent Bottle 3 Sample Rack 4 Dilution Segment 5 Sample Bar Co...

Page 33: ...omatically made in the wells of the dilution segments before delivery to the reaction wheel The disposable dilution segments are placed on the system by the user 5 Sample Bar Code Reader Scans bar codes on the sample carousel including bar coded sample tubes sample rack bar codes background bar codes calibrator bar codes reagent bar code cards calibrator bar code cards 6 Sample Carousel Advance Bu...

Page 34: ...ample crane transfers samples and diluents Sample dilutions are made in the dilution wells and then delivered to the reaction wheel The Sample Crane functions in the same manner as the Reagent Crane Refer to Figure 2 7 Figure 2 7 Sample Crane 1 Sample Probe Mixer 2 Sample Syringe Pump 3 Sample Crane Wash Station 4 Sample Addition Ports ...

Page 35: ...tes diluted sample from the dilution well and dispenses it into a cuvette on the reaction wheel Sample Paddle Mixer Mixes the contents of a cuvette while diluted sample is dispensed Also mixes in dilution wells 2 Sample Syringe Pump 250 µL Mechanism for accurate sample diluent and diluted sample aspiration and delivery through the sample probe 3 Sample Crane Wash Station Washes interior and exteri...

Page 36: ...instrument contains three subsystems Hydro Pneumatics Electronics Control Compartment Power Supply Assembly Hydro Pneumatics The hydro pneumatics control the flow of wash solution through the system and the flow of waste out of the system Pressure and vacuum control this fluid motion Refer to Figure 2 8 Figure 2 8 Hydro Pneumatics 1 Pressure Reservoir Liquid 2 Pressure Reservoir Air 3 Vacuum Reser...

Page 37: ... Description September 2016 Page 2 15 2 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 Figure 2 9 Electronics Compartment 1 Circuit Boards ...

Page 38: ...er 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 Figure 2 10 Power Supply Assembly 1 Power Tower 2 Power Switch 3 Electrical Outlet Voltage Selector ...

Page 39: ...te Container Component List The following lists the components depicted in Figure 2 11 1 Wash Solution Box 2 Wash Solution Tubing 3 Waste Container 4 Waste Tubing Table 2 6 Wash Solution Box and Waste Container Components Item Component Function 1 Wash Solution Box Holds wash solution 2 Wash Solution Tubing blue and orange Blue Connects wash solution box to instrument Orange vents wash solution to...

Page 40: ...n The wash solution is used to wash the probes mixers and cuvettes Wash Solution Box Placement 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 ...

Page 41: ...ack number by the instrument Refer to Figure 2 12 Figure 2 12 Sample Rack Types of Racks There are four types of racks They are identified by the size of sample tube that they hold 16 100 mm 16 75 mm 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 1 Rack Bar Code Label 2 Rack Number 3 Han...

Page 42: ...he steps below to load a rack onto the sample carousel Refer to Figure 2 13 Figure 2 13 Loading Rack onto the Sample Carousel Step Action 1 Press the Advance button to advance the sample carousel to an empty slot 2 Lift the rack by its handle 3 Open the cover of the sample carousel 4 Align rack pegs over holes in the sample carousel 5 Lower rack pegs into carousel holes ...

Page 43: ...stored on the computer 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 The status of the battery is checked every time the Power On sequence is performed NOTICE Only the computer supplied by Beckman Coulter is to be used with the IMMAGE 800 Immunochemistry System CAUTION The date and t...

Page 44: ...py diskette drive CD ROM Drive 2 Floppy Diskette Drive Where a 3 5 inch floppy diskette is placed and read 3 CD ROM Drive Where a CD ROM is placed and read 4 Keyboard 101 key enhanced keyboard 5 Mouse A two button movable input device 6 Monitor Displays user interface touch screen 7 Uninterruptible Power Source UPS The backup power source providing temporary power to the computer for a limited per...

Page 45: ... 2 Keyboard Figure 2 14 depicts the 101 key enhanced keyboard used on the IMMAGE 800 Figure 2 14 IMMAGE 800 Keyboard 1 Escape Key 2 Function Keys 3 Tab Key 4 Caps Lock Key 5 Shift Keys 6 Control Keys 7 Alt Keys 8 Backspace Key 9 Enter Key 10 Delete Key 11 Page Up Key 12 Page Down Key 13 Arrow Keys ...

Page 46: ...ng Recommended diskette 3 5 inch Double sided High density IBM formatted diskette Store away from electrical motors power supplies or generators Keep away from magnets and magnetic fields Proper Care and Handling of a Compact Disk 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...

Page 47: ...e 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 Refer to the manual that accompanies the printer for proper setup care and handling of the printer ...

Page 48: ...ntroduction 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 The Main Software screen is shown below Figure 2 16 Main Screen E011433S EPS ...

Page 49: ...ng screen of the IMMAGE 800 as an example of this interface This screen is broken into six functional areas Status Bar Menu Bar Title Bar Function Buttons Message Bar Working Area Figure 2 17 Sample Programming Screen Status Bar The blue bar at the top of the screen is the status bar This bar shows the instrument status date and time 1 Status Bar 2 Menu Bar 3 Icon Button 4 Title Bar 5 Function But...

Page 50: ...hat are specific to the particular screen Each function button on the screen corresponds to a function key on the keyboard read from left to right F1 F2 F3 etc The screen function buttons are labeled with the action the function button performs and the corresponding keyboard function key Options Button Within the working area and occasionally on screens or dialog boxes are buttons that perform a d...

Page 51: ...rking Area The middle portion of the screen is referred to as the working area The user enters data into the working area via Text fields Buttons Toggle buttons Check boxes Figure 2 18 Working Area of Program Sample Screen 1 Text Field 2 Cursor 3 Options Button 4 Toggle Button 5 Check Box E010270S EPS 5 2 3 4 1 ...

Page 52: ...ise noted most text fields can accept any alphanumeric characters This means that the user can type in any letter number or a space Each text field has a limited number of characters that can be entered Most text fields have a restricted set of characters that can be entered Example If the user attempts to enter anything other than a number in a numeric field the character will not be entered A me...

Page 53: ...mplies When they are selected or pressed an action is performed in the software Often this action will be used to access a new screen or dialog box 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 ...

Page 54: ...he same manner as buttons except when they are selected or pressed their state is changed Selected or Unselected 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 ...

Page 55: ...ion Check boxes are similar to toggle buttons because they are either toggled on or off When selected a check box will change state States 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 ...

Page 56: ...ferred to as dragging 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 cursor movement is directed either within a partition local movement which is a logical grouping of data fields that may or may not be visually distinct from other groupings or is dir...

Page 57: ... entered as soon as the item is chosen If the item is a button the button can be selected by pressing the Spacebar Page Up Page Down Buttons An exception to the use of the Tab key or arrow keys are page up page down buttons These buttons cannot be chosen The Page Up and or Page Down keys on the keyboard are equivalent to the Page Up and Page Down buttons respectively Selecting a Number from a List...

Page 58: ...r to the various items on the screen by highlighting one item at a time An item is highlighted when a dark line appears around it When the item is highlighted that item is chosen but no action occurs Selecting Definition Pressing the Spacebar selects the chosen item on the screen When an item is selected the software performs the appropriate action Text fields cannot be selected only chosen Select...

Page 59: ...of any screen Figure 2 19 Dialog Box Example Cancel Most dialog boxes will have a Cancel button This button closes the dialog box without entering the requested data or denies confirmation of an action If this button is selected no data is entered no action is performed the dialog box closes This button can also be selected by pressing Alt c OK Some dialog boxes will have an OK button This button ...

Page 60: ... to delete data from a text field 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 Step Action 1 Choose the text field 2 Choose one Press the Delete key to delete the entire field Press the Backspace key to delete a single character prior to the cursor Drag through any port...

Page 61: ...mple screen is a multipage list Use of Page Up Page Down The user can access additional pages of data by selecting the page up and page down buttons on the right The page numbers are shown above the buttons Selecting the Page Down button will advance the page to the next page Selecting the Page Up button will return the page to the previous page These buttons only appear if more than one page of d...

Page 62: ...displays an overview to the structure of the IMMAGE 800 software divided into its functional groups Figure 2 20 IMMAGE 800 Program Tree 1 of 5 Main Stop Home Pause Run Samples Control Batch F1 Demog F2 Demographics Program Sample F1 Save Next F10 Sample Options F3 Link Sample Set Variable OK Cancel Program Batch F4 Select Racks F1 End Batch F10 Select Control F5 Sample Options F3 Select Control F5...

Page 63: ...ort F8 Prev Sample F9 Next Sample F10 Cancel Send F4 Send to Host F8 Report Format F9 Print Report F10 Rgts Cal Read Reagent F1 Reagents Calibration Reagent Summary F2 Buffer Diluent F3 Request Cal F4 Clear Racks F1 Request Calibration Save F9 Cancel F10 Cal Options F5 Calibrator Summary Calibration Options Slope Offset Adjustment Print Last Calibration Results Cal LdList F6 Calibration Loadlist C...

Page 64: ... Quality Delete Control F3 Control Print Control F10 Define Edit F2 Add Del Chems F1 Control ID F2 Delete Control F3 Delete Control F3 QC File List F4 List CtlName F1 List File F2 List SelChem F3 List AllChem F4 Print F10 QC Log F5 QC Log F1 Reagent Lot F2 Delete Result F3 Action Log F4 Print F10 QC Summary F6 Print Inter Lab F9 Print F10 QC Chart F7 Control Chems F1 QC File F2 Print F10 ...

Page 65: ...ete Panels F2 Panels Summary F2 Print All F10 Prev Panel F9 Next Panel F10 Bar Code Restore Default F1 Reference Interval Report Setup Restore Default F1 Calculations View Edit F1 Select TUrine F2 Define Calc F3 Delete Calc F4 Define Var F5 Units Non standard Dilutions Restore Default F1 Print All F10 Antigen Excess Restore Default F1 Date Time Restore Default F1 Change Date F2 Change Time F3 Host...

Page 66: ...ime Utilities Event Log Display Events F1 Copy to Disk F2 Date Time F3 Clear Events F4 Print F10 Diagnostics Cycle Count Call Diagnostics Alignment Prev Align F1 Previous Alignment Format QNX Diskettes Backup Restore Wash Cuvettes Fill Internal Wash Bottle Stop Print Reload DAS Code Calibrate Touch Screen Shutdown Status Dilution Segments Sample Carousel Status ...

Page 67: ...amming Options BarCoded Samples Host Interface Sample Programming Yes Host Query None required Load samples in any rack and position No Bi directional None required Load samples in rack and position assigned by host Yes Bi directional None required Load samples in any rack and position No Unidirectional Required Enter rack and position number sample ID and chemistries Load samples in assigned rack...

Page 68: ...ack None Front 3 inches 7 6 cm minimum Top 4 inches 10 1 cm from top of instrument Dimensions Excluding Wash and Waste Bottles Height 30 inches 76 2 cm Depth 25 5 inches 64 8 cm Length 43 5 inches 110 5 cm Weight 250 lb 120 kg Power Requirements Supplemental Specifications Operating Range 100 120VAC 200 240VAC Single Phase Frequency Range 50 60 Hz Transient Suppression Recommended BTU Generated 2 ...

Page 69: ...ent 120V 60 Hz 40 uA 240V 50 Hz 68 uA WARNING IF THE EQUIPMENT IS USED IN A MANNER NOT SPECIFIED BY BECKMAN COULTER INC THE PROTECTION PROVIDED BY THE EQUIPMENT MAY BE IMPAIRED Ambient Temperature 15 C to 32 C Ambient Relative Humidity RH 15 to 85 non condensing Reagent Compartment Temperature 13 22 C 32 C Ambient 45 RH Reaction Module Temperature 37 C 0 5 C Table 2 9 System Capacities Item Capaci...

Page 70: ... Capacities System Description IMMAGE 800 Operations Manual A11403 Page 2 48 September 2016 Wash solution 1 box 10 L approximately 1 000 tests Waste container 5 gallons 18 9 L Table 2 9 System Capacities continued Item Capacity ...

Page 71: ... IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2 49 2 Peripheral Devices Specifications Introduction Refer to the inserts which accompany the respective peripheral devices computer printer etc for product specifications ...

Page 72: ...System Primary Tubes 16 100 mm 10 mL 16 75 mm 7 mL 13 100 mm 7 mL 13 75 mm 16 5 92 mm Secondary Aliquot Tubes 16 100 mm 16 75 mm 13 100 mm 12 75 mm Microtubes 13 100 mm SYNCHRON Microtube Sample Cups 2 mL placed into a sample cup holder 0 5 mL placed into a sample cup holder NOTICE Low humidity and high ambient temperature may cause evaporation when using small volumes of sample in sample cups To ...

Page 73: ...aracter values and is the last digit of the bar code ID Code 39 expects the check digit to be included in the final code length Large Intercharacter Gap In Code 39 the intercharacter gap has a minimum value of one times the width of the narrow element and a maximum value of three times the width of the narrow element or 0 06 inches 0 152 cm whichever is greater This feature should be enabled when ...

Page 74: ...gth Two A second code length an even number from 0 to 14 may be defined Both lengths would then be recognized Codabar Options Start and Stop Codes Match When this option is enabled the start code and stop code must be the same character for a valid read Large Intercharacter Gap This option is used when reading Codabar labels with large gaps between bar code characters The normal intercharacter gap...

Page 75: ... or percentage sign dollar sign comma quotation mark ampersand asterisk semi colon question mark back slash caret tilde or piping bar cannot be used as a character Margin of Reading Accuracy Bar code symbol narrow element width of 0 19 to 0 51 mm 0 0075 to 0 02 inch Wide element to narrow element ratio of 2 2 1 to 3 0 1 Placing a Tube into a Rack Tubes should be seated to the bottom of the rack wi...

Page 76: ...kman Coulter Inc recommends the following printers Please contact any of the above vendors or industry standard associations for any specific bar code application issues Execuport 2400 Computer Transceiver Systems P O Box 1117 23 Carol Street Clifton NJ 07014 0996 Phone 201 473 4700 Intermec 3000A Intermec Corporation 6001 36th Avenue West Everett WA 98203 Phone 1 800 755 5505 Zebra 130 Zebra Tech...

Page 77: ...ication of Bar Codes IMMAGE 800 Operations Manual A11403 System Description September 2016 Page 2 55 2 Applying Bar Code Labels Correct Application of Bar Codes Refer to the IMMAGE Sampling Template for the correct application of bar codes ...

Page 78: ...l A11403 Page 2 56 September 2016 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 ...

Page 79: ...with the bar code labels facing the same direction as the sample rack bar code label Refer to Figure 2 25 Confirm that the tube is properly seated in the bottom of the rack Be sure the entire bar code symbol including quiet zone is visible through the rack Example Figure 2 25 Bar Coded Tube Orientation NOTICE The bar code must be visible to the Sample Bar Code Reader otherwise the sample will not ...

Page 80: ...lines wash the probes perform internal diagnostic checks 2 A fluid level sense is performed on all Buffer and Diluent bottles The volume remaining is then calculated 3 Sample and Reagent carousels are spun Bar codes for both reagent and samples are read If the reagent load procedure has been performed and the reagent cover has not been opened the reagent carousel is not reread 4 The on board refer...

Page 81: ...ued Stage Description 2 of 2 Table 2 12 Data Reduction Functions Stage Description 1 The reaction wheel operates on a 5 second cycle time During each cycle the cuvettes are spun in front of the optics station and 200 data points are taken These 200 points per cuvette are then calculated to a single value 2 For each spin the calculated value the time the data was taken and a calculated quality valu...

Page 82: ...Instrument Operation Data Reduction System Description IMMAGE 800 Operations Manual A11403 Page 2 60 September 2016 ...

Page 83: ...tions September 2016 Page 3 1 3 CHAPTER 3 Theory of Operations Table of Contents 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 ...

Page 84: ...nciples of Rate Turbidimetry The rate turbidimeter measures the decrease in the intensity of light as it passes through a solution of light scattering particles in a cuvette The light source for the rate turbidimeter is an light emitting diode LED at a wavelength of 940 nm Turbidimetric measurements are made at 0 from the incident beam as shown in Figure 3 1 Figure 3 1 IMMAGE 800 Rate Nephelometer...

Page 85: ... This decrease is converted to an increasing scatter signal by the formula Rate nephelometry and rate turbidimetry give the same signal as illustrated in Figure 3 2 Figure 3 2 Scatter Signal versus Time for Rate Nephelometry and Rate Turbidimetry Rate Determination The system monitors scatter signal from the antigen antibody reaction at 5 second time intervals At the end of the reaction the system...

Page 86: ...teracting with the serum Dynamics of the Immunoprecipitin Reaction The formation of light scattering complexes is dependent on the presence of antigen and antibody molecules in optimal proportions In general the reagent contains a fixed amount of antibody which binds with antigen in the sample to form light scattering complexes Refer to Figure 3 3 Figure 3 3 Antigen antibody Reaction Under Varying...

Page 87: ... increases from test sample A to test sample F The rate response for test sample G is less than for sample F although the antigen concentration in sample G is greater than sample F Test sample H illustrates a further reduction in the rate response due to the increase in antigen concentration in the sample Figure 3 4 Protein Rate Response Curve 1 X Increasing Antigen Concentration 2 Y Peak rate of ...

Page 88: ...o a high molecular weight carrier The conjugate competes with the free drug hapten in the sample for available binding sites on the antibody Increased drug in the sample results in a decrease in the formation of insoluble complexes Figure 3 5 illustrates the conjugate antibody reaction in the presence of hapten drug Figure 3 5 Inhibition of Immunoprecipitin by Hapten drug 1 Conjugate antibody comp...

Page 89: ...e for several test samples with various hapten concentrations The magnitude of the rate response decreases from test sample A to test sample E Sample E has a very low rate response indicating a high hapten concentration in the sample Figure 3 6 Drug Rate Response Curve 1 X Increasing free hapten drug concentration 2 Y Peak rate of scatter 3 A E represent peak rate values at varying free hapten lev...

Page 90: ... enabled Refer to CHAPTER 5 System Setup Configuring Antigen Excess Testing A reaction is ambiguous if the rate response could represent either an antigen excess or an antibody excess reaction Antibody Excess When the reaction is to the left of the optimal antibody antigen proportions center line the reaction is in antibody excess AbXS Refer to Figure 3 7 This indicates all the antigen in the samp...

Page 91: ...e Either the rate response represents the correct concentration in the area of AbXS left side or the same rate response represents a concentration that is in the area of AGXS right side and requires further dilution Antigen excess testing differentiates these two situations Refer to Figure 3 7 Figure 3 7 Antigen Excess Detection 1 X Increasing antigen concentration 2 Y Rate response 3 Antibody exc...

Page 92: ...g If unbound Ab is the addition of more Ag will result in and the IMMAGE 800 will present an increase in rate response as indicated by the solid line in Figure 3 8 use the initial rate response to calculate the final result not present no increase in rate response as indicated by the broken line in Figure 3 8 automatically rerun the sample at the next higher dilution and test for antigen excess un...

Page 93: ... 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 Samples above or below the initial measuring range will automatically be retested at the next appropriate dilution refer to IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix B M...

Page 94: ... during calibration is reproduced within a predefined percentage The averaged rate of the two replicates is used to establish a calibration scale factor based on the assigned calibrator target value The calibration scale factor is used to adjust the measured rate response to equal the theoretical response Protein Calibration Curve When the antibody concentration is constant the rate response will ...

Page 95: ...l A11403 System Power On Off September 2016 Page 4 1 4 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 ...

Page 96: ... on the CPU 6 Turn on the instrument 7 Close reagent and sample carousel covers 8 When the note is displayed to check dilution segment status select OK 9 When the temperature warning note displays select OK The system will continue to bring the reagent chamber and reaction cuvettes to the appropriate temperature range The system will not allow a run to start until the reaction cuvettes are within ...

Page 97: ...al Information Refer to CHAPTER 1 General Information Precautions and Hazards for a description of switches and port connections 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 ...

Page 98: ...m Emergency Stop Turn the instrument main power switch off if the stop button on the screen is unavailable and the instrument must be stopped immediately NOTICE The database may become corrupted if power is turned off before the Power Off sequence is completed Step Action 1 Check that the floppy diskette drive is empty 2 Select Utilities from the menu bar 3 Select Shutdown 4 When the message Shutd...

Page 99: ...esults and samples that have not been run Quality control files All system software setup configurations Event logs All instrument hardware settings Information Changed The following information and or screens will be changed after power is restored Table 4 1 Information Changed After Power is Restored Information Screen Change Dilution Segments dialog box All segments go to 0 wells available Samp...

Page 100: ...anual A11403 Page 4 6 September 2016 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: ...age Setup 5 65 Loading the Chemistry Protocol Diskette 5 66 Instrument Serial Number Setup 5 67 User Defined Reagent Chemistry Setup 5 68 UDR Chemistry Overview and Precautions 5 68 Setting Up a UDR Chemistry 5 69 Defining a UDR Chemistry 5 74 Defining UDR Calibration Information 5 83 Deleting UDR Chemistries 5 84 Editing UDR Definitions 5 85 Loading UDR Reagent Cartridges 5 87 Loading Clearing UD...

Page 102: ...face These configurations can be changed when the system status is in Standby This chapter explains how to configure the chemistry menu set up panels set up bar codes set up reference intervals set up reports set up special calculations set up units non standard dilutions configure antigen excess testing set up date and time set up host communications set up replicates statistics set up sample com...

Page 103: ...ge 5 3 5 Accessing Setup The instrument status must be in Standby in order to proceed with the steps below to access the Setup screen Figure 5 1 Setup Screen Step Action 1 Select Setup from the menu bar 2 Choose the desired setup option from a numbered button Refer to Figure 5 1 E011414S EPS ...

Page 104: ...Defining a Chemistry for a Position The instrument status must be in Standby in order to proceed with the steps below to define a chemistry Figure 5 2 Chemistry Configuration Screen Step Action 1 From the Setup screen select 1 Chemistry Configuration Refer to Figure 5 2 2 Choose the position for the chemistry 3 Choose one Type the Beckman Coulter chemistry acronym if known e g IGG OR Select Beckma...

Page 105: ...re Refer to Defining a Chemistry for a Position in this section The instrument status must be in Standby in order to proceed with the steps below to insert a blank position Step Action 1 From the Setup screen select 1 Chemistry Configuration 2 Select Clear All F4 3 Select OK to clear all of the configured chemistries OR Select Cancel to return to the Chemistry Configuration screen without clearing...

Page 106: ... any configured panel in which it is defined accumulated QC data for the chemistry is not deleted Step Action 1 From the Setup screen select 1 Chemistry Configuration 2 Choose a position for the chemistry to be deleted 3 Select Delete Chem F6 4 Select OK to delete the chemistry OR Select Cancel to return to the Chemistry Configuration screen without deleting chemistry NOTICE If the error message U...

Page 107: ...5 3 Define Print Names Dialog Box Step Action 1 From the Setup screen select 1 Chemistry Configuration 2 Select Define PrtName F3 Refer to Figure 5 3 The chemistry menu will be displayed If there are chemistries defined for positions greater than 20 the Page Up and Page Down buttons can be used to show additional pages of chemistries 3 Choose the text field beside the desired chemistry 4 Type the ...

Page 108: ...ion Loading Unloading Reagent Cartridges for information on unloading chemistries Refer to CHAPTER 7 Sample Programming Selecting Chemistry Tests by Panel and 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 ...

Page 109: ...lphanumeric characters Refer to Figure 5 5 5 Select the number beside each desired chemistry for the panel being defined Selecting Clear Chems F1 will deselect all of the selected chemistries 6 Select the options button beside Sample Type 7 Select the sample type The default sample type is determined by the sample type selected on the Default Setup screen Refer to Default Setup Setting the Default...

Page 110: ...Panel Setup Defining New Panels System Setup IMMAGE 800 Operations Manual A11403 Page 5 10 September 2016 Figure 5 4 Panels Summary Screen Figure 5 5 Panels Screen E014094S EPS E014095S EPS ...

Page 111: ...utton beside Sample Type to change the sample type 7 Select the sample type The default sample type is determined by the sample type selected in the Default Setup screen Refer to Default Setup Setting the Default Sample Type in this chapter to change the default sample type 8 Select the AGXS check box beside the desired chemistry to enable or disable antigen excess testing 9 Select the options but...

Page 112: ...eed with the steps below to delete defined panels Step Action 1 From the Setup screen select 2 Panels A multipage list of panel summaries will be displayed 2 Select the numbers beside the panels to be deleted 3 Select Delete Panels F2 4 Select OK at the Delete ALL selected panels dialog box OR Select Cancel to return to the list of panel summaries without deleting the panels ...

Page 113: ... The instrument status must be in Standby in order to proceed with the steps below to enable or disable bar code symbologies Figure 5 6 Bar Code Setup Screen Step Action 1 From the Setup screen select 3 Bar Code Refer to Figure 5 6 2 To enable a bar code symbology select the check box beside the symbology If the check box is checked the symbology is enabled 3 To disable a bar code symbology desele...

Page 114: ...he defaults for bar code parameters are in bold 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 Table 5 1 Bar Code Parameters Parameter Code 39 Codabar Interleaved 2 of 5 Start Stop Codes Match NA1 1 Not applicable Enabled ...

Page 115: ...are available for selection only for enabled bar code types 3 Select options appropriate for your bar code system 4 Define any code lengths if necessary by typing the number in the appropriate field 5 Select OK to save the parameters OR Select Cancel to return to the Bar Code Setup screen without saving the parameters 6 If additional bar code parameters are to be set repeat Steps 2 5 If the Bar Co...

Page 116: ...code symbology defaults Additional Information CHAPTER 7 Sample Programming Selecting Save Next Programming a Batch of Samples Identifying a Batch Step Action 1 From the Setup screen select 3 Bar Code 2 Select Restore Default F1 to return all bar code setups to their defaults 3 Select OK at the confirmation screen to restore the defaults OR Select Cancel to return to the Bar Code Setup screen with...

Page 117: ... save a reference interval are low age low age unit high age high age unit low reference interval number and high reference interval number Defining Editing Sample Type and Sex The instrument status must be in Standby in order to proceed with the steps below to define a sample type and sex for intervals and ranges Step Action 1 From the Setup screen select 4 Reference Interval Refer to Figure 5 7 ...

Page 118: ...Ranges Dialog Box Figure 5 8 Reference Interval Critical Ranges Screen Choices for Age Field Entries The following choices are available for the age field entries E010308S EPS E010309S EPS Table 5 2 Age Field Entries Field 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 ...

Page 119: ...erence intervals and critical ranges Step Action 1 From the Reference Interval Critical Ranges screen type the low age in the Low field Press Tab Refer to Figure 5 8 2 Type the age unit in the field next to the low age Press Enter 3 Type the high age in the High field Press Tab 4 Type the age unit in the field next to the high age Press Enter 5 Type the low and high reference interval numbers in t...

Page 120: ...on 8 Select another sample type and or sex to define additional groups of the chemistry calculation Repeat Steps 1 7 OR Select Prev Chem F9 or Next Chem F10 to define other chemistries Repeat Steps 1 7 OR Select any icon from the menu bar to exit the screen Step Action continued 2 of 2 Step Action 1 From the Setup screen select 4 Reference Interval Refer to Figure 5 7 2 Select the button beside th...

Page 121: ...le chemistries calculations may be chosen 3 Select Define Edit Refer to Figure 5 7 4 Select a field on the interval range line that is the current default 5 Select Select Default F3 The symbol is removed from the far left of the line 6 Select another sample type and or sex to move to other definitions within the same chemistry calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 fo...

Page 122: ...lculations can be chosen 3 Select Define Edit Refer to Figure 5 7 4 Select Clear Ranges F3 5 Select OK to clear the intervals and ranges for the chemistry calculation sample type and sex selected OR Select Cancel to return to the Reference Interval Critical Ranges screen without clearing intervals and ranges 6 Select another sample type and or sex to move to other definitions within the same chemi...

Page 123: ...mistry calculation 7 Select another sample type and or sex to insert lines from additional groups of the chemistry calculation Repeat Steps 4 5 OR Select Prev Chem F9 or Next Chem F10 to move to other chemistries calculations OR Select any icon from the menu bar to exit the screen Step Action continued 2 of 2 Step Action 1 From the Setup screen select 4 Reference Interval Refer to Figure 5 7 2 Sel...

Page 124: ...d range definitions Additional Information Refer to Configuring the Chemistry Menu and to Calculations Setup in this chapter for chemistry and calculations setup information Step Action 1 From the Setup screen select 4 Reference Interval Refer to Figure 5 7 2 Select the button beside the chemistry calculation to be printed Multiple chemistries calculations can be chosen 3 Select Print 4 All defini...

Page 125: ...eport header can include the facility name and the facility address The instrument status must be in Standby in order to proceed with the steps below to define the report header Figure 5 9 Report Setup Screen Step Action 1 From the Setup screen select 5 Report Setup Refer to Figure 5 9 2 If desired type the name of the facility in the Facility Name field up to 60 alphanumeric characters 3 If desir...

Page 126: ...isable automatic printing Step Action 1 From the Setup screen select 5 Report Setup Refer to Figure 5 9 2 Select the options button beside Patient under Report Format 3 Select the number for the appropriate format Refer to APPENDIX B Reports for format examples Lab Report Lab Report Dilutions Patient Chartable Reports The default patient report format is Lab Report Step Action 1 From the Setup scr...

Page 127: ... of report formats refer to APPENDIX B Reports Step Action 1 From the Setup screen select 5 Report Setup Refer to Figure 5 9 2 Type the laboratory Inter Lab ID number beside the ID Number field up to 9 numbers The default is blank 3 Type the name of the attention person beside Attention Person field up to 30 alphanumeric characters The default is blank Step Action 1 From the Setup screen select 5 ...

Page 128: ...ple or two linked samples The default for calculations is disabled Calculation Description The following table describes the 12 calculations available on the IMMAGE 800 Table 5 3 Calculations Available on IMMAGE 800 Calculation Name Chemistries Run for Calculation Formula APA APB Apolipoprotein A Apolipoprotein B serum APA serum APB APB APA Apolipoprotein B Apolipoprotein A serum APB serum APA KAP...

Page 129: ...ory Refer to Table 5 4 Enabling a Calculation The instrument status must be in Standby in order to proceed with the steps below to enable a calculation ALB Index Albumin CSF and serum CSF ALB serum ALB IGG Index IGG CSF and serum CSF IGG serum IGG IGA Index IGA CSF and serum CSF IGA serum IGA IGM Index IGM CSF and serum CSF IGM serum IGM Table 5 3 Calculations Available on IMMAGE 800 continued Cal...

Page 130: ...1 Calculations Screen 5 Select Prev Calc F9 or Next Calc F10 to move to another Calculations screen OR Select Calc Summary F1 or an icon from the menu bar to return to the Calculations Summary screen 6 If the Excretion Rate Calculation is enabled go to Selecting Urine Chemistries for Excretion Rate Calculations Step Action continued 2 of 2 E014091S EPS E010306S EPS ...

Page 131: ...sample When the instrument status is in Standby proceed with the steps below to enable urine chemistries for excretion rate calculations Figure 5 12 Define Timed Urine Chemistries Dialog Box Step Action 1 From the Setup screen select 6 Calculations Refer to Figure 5 10 2 Select Select TUrine F2 Refer to Figure 5 12 3 Select the check box beside the urine chemistry desired for the excretion rate ca...

Page 132: ...ield 3 Select View Edit F1 4 Select the options button beside the Unit field From the Calculation Unit screen select the number next to the desired unit OR Enter the number corresponding to the desired unit AND Press Enter 5 Select Calc Summary F1 OR Select any icon from the menu bar 6 From the Warning screen select OK to change the unit OR Select Cancel to exit without changing the unit Step Acti...

Page 133: ... Custom Calculation individually If the sample type defined for a calculation is serum the calculation is applied to samples with a sample type of serum or plasma If the sample type defined for a calculation is plasma the calculation is applied to samples with a sample type of serum or plasma Custom Calculations that require two samples must be linked through Sample ID Each sample can only be link...

Page 134: ...tal of six chemistries and or variables per calculation The order of precedence when using mathematical operations in a calculation formula are 1st brackets 2nd exponent 3rd multiplication division 4th addition subtraction 6 Select the options button beside Sample Type 1 1 or Sample Type 2 2 to select the sample type s NOTICE The same sample type cannot be defined for Sample Type 1 1 and Sample Ty...

Page 135: ...heck box next to Enable Calculation to enable or disable the use of the calculation and press Enter to continue 6 To edit the calculation formula enter a formula with a maximum total of six chemistries and or variables per calculation and press Enter to continue The order of precedence when using mathematical operations in a calculation formula are 1st brackets 2nd exponent 3rd multiplication divi...

Page 136: ...tion if more than one Custom Calculation is chosen Next Calc F10 advance to the next calculation if more than one Custom Calculation is chosen 9 Select any icon from the menu bar to exit Step Action continued Step Action 1 From the Setup screen select 6 Calculations OR Enter 6 in the Options No field 2 Select the number s beside the Custom Calculations desired OR Enter the number s corresponding t...

Page 137: ...sired chemistry Refer to Figure 5 14 The default units are displayed 3 Select the number beside the units desired for the selected chemistry and sample type OR Select Cancel to return to the Units screen without changing the units 4 If the units selected are in a different category than the default units a Units Conversion dialog box is displayed Refer to Figure 5 15 and Table 5 4 The default unit...

Page 138: ...Chemistry System Setup IMMAGE 800 Operations Manual A11403 Page 5 38 September 2016 Figure 5 13 Units Non Standard Dilutions Screen Figure 5 14 Units Dialog Box Figure 5 15 Units Conversion Dialog Box E011415S EPS E010221S EPS E010220S EPS ...

Page 139: ...lutions for each chemistry The instrument status must be in Standby to proceed with the steps below to restore defaults Table 5 4 Units Categories Weight Volume Mass Volume International Units Volume Units Volume g L mol L IU L U L mg L mmol L mIU L U dL g dL µmol L µIU L U mL mg dL nmol L IU mL µg dL pmol L mIU mL pg dL µIU mL mg mL µg mL ng mL pg mL Step Action 1 From the Setup screen select 7 U...

Page 140: ...ion 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 Step Action 1 From the Setup screen select 7 Units Non Standard Dilutions Refer to Figure 5 13 2 Select the sample type Then sele...

Page 141: ... Standard Dilutions as Default for Each Chemistry Selecting a Non Standard Dilution IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 41 5 Figure 5 16 Non Standard Dilutions Display E011416S EPS ...

Page 142: ...ated chemistry If AGXS testing is disabled AGXS testing will not be performed for the associated chemistry AGXS can be enabled or disabled for an individual sample in Sample Programming How to Configure AGXS Testing The instrument status must be in Standby in order to proceed with the steps below to configure AGXS testing Figure 5 17 Antigen Excess Screen Step Action 1 From the Setup screen select...

Page 143: ...16 Page 5 43 5 Restoring Defaults The instrument status must be in Standby in order to proceed with the steps below to restore the default Step Action 1 From the Setup screen select 8 Antigen Excess 2 Pressing Restore Default F1 will set AGXS testing to enabled for all appropriate chemistries requiring AGXS testing ...

Page 144: ...ed with the steps below to format date parameters Step Action 1 From the Setup screen select 9 Date Time Refer to Figure 5 18 2 Format the order of the date by selecting the button beside Order Select either 1 Month Day Year 2 Day Month Year 3 Year Month Day 3 Format the day by selecting the button beside Day Format Select either 1 Leading Zero 01 2 No Leading Zero 1 4 Format the month by selectin...

Page 145: ...em Setup September 2016 Page 5 45 5 Figure 5 18 Date and Time Screen 6 Determine the appropriate date separator then delete the current separator in the Separator field type in the appropriate separator any non alphabetic character Example Step Action continued 2 of 2 E010224S EPS ...

Page 146: ...9 Date Time Refer to Figure 5 18 2 Format the time by selecting the button beside Time Format Select either 1 24 Hour 2 12 Hour 3 Format the hour by selecting the button beside Hour Format Select either 1 Leading Zero 01 2 No Leading Zero 1 4 Determine the appropriate time separator then delete the current separator in the Separator field type in the appropriate separator Date Display Format Defau...

Page 147: ...s for month can be entered with or without a leading zero For example 4 or 04 may by entered for April 4 Correct the day displayed above the dd if needed delete the currently displayed day type the correct day in its place The digits for day can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by entered for the fourth day of the month 5 Correct the year ...

Page 148: ...lace The digits for hour can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by entered for four o clock 4 Correct the minute displayed above the mm if needed delete the currently displayed minute type the correct minute in its place The digits for minute can be entered with or without a leading zero for numbers less than ten For example 4 or 04 may by e...

Page 149: ...lapping time period is created Example Old time 11 PM New set time 10 PM The overlapping time period is 1 hour If a run is finished at 11 PM old time and another is run finished by11 PM new time the overlapping time period of 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 ...

Page 150: ...urther information about all of the host communications parameters is found in the IMMAGE Immunochemistry Systems Host Interface Specifications Entering Sender ID The Sender ID is a free text field sent with each message header record to the host if the Message Header Mode is set to Full Header The instrument status must be in Standby in order to proceed with the steps below to enter the Sender ID...

Page 151: ...GE 800 to a host computer Step Action 1 From the Setup screen select 10 Host Communications Refer to Figure 5 21 2 Select the options button next to one of the following parameters refer to Table 5 5 Baud Rate Stop Bits Parity Data Bits 3 Select the choice that matches the parameter of the host OR Select Cancel to exit the dialog box without setting a parameter The choices are shown in Table 5 5 4...

Page 152: ...pproved and sent to the LIS from the Recall Results By screen Refer to CHAPTER 8 Results Recall The instrument status must be in Standby in order to proceed with the steps below to enable or disable auto send results Step Action 1 From the Setup screen select 10 Host Communications Refer to Figure 5 21 2 Select the options button beside Timeout Value to enter the Timeout Value dialog box 3 Select ...

Page 153: ...y mode Enabling Disabling Continuous Numbering Mode The frame is a basic unit of data transmission When the continuous numbering mode is checked enabled frame numbers from the host will not be reset at 1 with the next header record The instrument status must be in Standby in order to proceed with the steps below to enable or disable the continuous numbering mode Step Action 1 From the Setup screen...

Page 154: ...tch processing The instrument status must be in Standby in order to proceed with the steps below to select the request information mode Step Action 1 From the Setup screen select 10 Host Communications Refer to Figure 5 21 2 Select the options button beside Operational Mode to enter the Operational Mode dialog box 3 Select the number next to one of the operational modes below 1 None 2 UniDirection...

Page 155: ...ow to restore the host communication parameter defaults Step Action 1 From the Setup screen select 10 Host Communications Refer to Figure 5 21 2 Select the options button beside Message Header Mode to enter the Message Header Record Mode dialog box 3 Select the number next to one of the operational modes below 1 Full Header 2 Abbreviated Header OR Select Cancel to exit the Message Header Record Mo...

Page 156: ... Immunochemistry Systems Host Interface Specifications Table 5 6 Host Communication Parameter Defaults Parameter Default Sender ID blank Baud Rate 9600 Stop Bits 1 Parity None Data Bits 8 Timeout Value 1 minute Auto Send Results Enabled Error Display Mode Enabled Continuous Numbering Mode Enabled Operational Mode None Request Information Mode Single Message Header Mode Abbreviated Header ...

Page 157: ...t setup of the Calibration Halt function Setting the Default Sample Type The instrument status must be in Standby in order to proceed with the steps below to define default sample types Step Action 1 From the Setup screen select 11 Default Setup Refer to Figure 5 22 2 Select options button beside Default Sample Type 3 Select the button beside desired default sample type from the choices below Seru...

Page 158: ...icates The instrument status must be in Standby in order to proceed with the steps below to set the desired number of system replicates E014092S EPS Step Action 1 From the Setup screen select 11 Default Setup Refer to Figure 5 22 2 Type the desired number of system replicates 1 to 9 in the System Replicates field 3 Select OK to return to the Chemistry Configuration screen OR Select Cancel to retur...

Page 159: ...mber beside the desired time search option OR Enter the number of the desired time search in the Option No field and press Enter OR Select Cancel to return to the Default Setup screen without changing the Post Run Summary Time search The default Post Run Summary time has no time restriction 4 Select OK to return to the Setup dialog box and change the Post Run Summary Time Search OR Select Cancel t...

Page 160: ...l 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 Figure 5 23 Sample Comments Screen Step Action 1 From the Setup screen select 12 Sample Comments Refer to Figure 5 23 2 Choose a text field beside a comment number 3 Type a comment up to 25 characters lon...

Page 161: ...p September 2016 Page 5 61 5 Editing a Sample Comment The instrument status must be in Standby in order to proceed with the steps below to edit a sample comment Step Action 1 From the Setup screen select 12 Sample Comments Refer to Figure 5 23 2 Choose the comment to be edited 3 Edit the comment ...

Page 162: ...ields to be Displayed in Sample Programming The instrument status must be in Standby in order to proceed with the steps below to select fields for display in sample programming Figure 5 24 Demographics Setup Screen Step Action 1 From the Setup screen select 13 Demographics Setup Refer to Figure 5 24 2 Select the check boxes beside the fields to be accessible in the Demographics screen of sample pr...

Page 163: ...ust be in Standby in order to proceed with the steps below to restore defaults to the Demographics Setup Step Action 1 From the Setup screen select 13 Demographics Setup 2 Select Restore Default F1 The default is all fields accessible 3 Select OK to restore defaults OR Select Cancel to return to the Demographics Setup screen without restoring the defaults ...

Page 164: ... size Figure 5 25 Printer Setup Dialog Box Restoring Default To restore the paper size default select Restore Default from the Printer Setup dialog box Step Action 1 From the Setup screen select 14 Printer Setup Refer to Figure 5 25 2 Select the options button beside Paper Size 3 Select the option number for the desired paper size OR Select Cancel to return to the Printer Setup dialog box 4 Select...

Page 165: ...e 5 26 Languages Keyboard Selection Dialog Box Step Action 1 From the Setup screen select 15 Languages Keyboard Refer to Figure 5 26 2 Select a language from the options button NOTICE Selecting Japanese from the Language options will cause the Language Keyboard selection to become unavailable Reloading of the software is necessary to restore the Language Keyboard Selection option OR Select Cancel ...

Page 166: ...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 Step Action 1 Select Setup from the menu bar 2 Select 16 Chemistry Protocol Diskette from the Setup screen 3 Insert the chemistry protocol diskette into the floppy diskette drive Refer to CHAPTER 2 System Description 4 S...

Page 167: ...l reports How to Enter the Serial Number When the instrument status is in Standby proceed with the steps below to enter the serial number of the instrument Figure 5 27 Serial Number Dialog Box Step Action 1 From the Setup screen select 17 Instrument Serial Number Refer to Figure 5 27 2 Type the instrument serial number in the Serial Number field up to 7 alphanumeric characters 3 Select OK to enter...

Page 168: ...no warranty whatsoever with respect to such sample and reagent performance including sample carryover test results reagent and cartridge handling their effect on the system or required system maintenance or the frequency thereof or their effect on operator safety User assumes full responsibility for use of the proper test protocol and test result generation for the reagent s selected by the user a...

Page 169: ...etup is described in the following steps Step Action 1 Select the Password Setup box near upper right corner of the User Defined Chemistries screen Refer to Figure 5 28 2 The User Log in screen appears Refer to Figure 5 29 Note that the Username field defaults to ADMIN Enter ADMIN in the Password field and select OK OR Select Cancel to return to the User Defined Chemistries screen 3 If OK was sele...

Page 170: ...016 Figure 5 28 User Defined Chemistries Screen Figure 5 29 User Login Screen 5 To delete a user select the username number and select Delete User OR Select Cancel to return to the Password Protection Mode Screen 6 Select Exit to return to the User Defined Chemistries screen Step Action continued E011417S EPS E011434S EPS ...

Page 171: ...try Password Setup Procedure IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 71 5 Figure 5 30 UDR User Setup Password Protection Mode Screen Figure 5 31 Define Edit User Screen E011435S EPS E011436S EPS ...

Page 172: ...er to proceed with the steps below to access the Define Edit screen Figure 5 32 Define Edit User Defined Chemistry Screen Page 1 Step Action 1 From the Setup screen select 18 User Defined Chemistries 2 Select the UDR Option Number Refer to Figure 5 28 3 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 ...

Page 173: ...Setting Up a UDR Chemistry Accessing Define Edit IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 73 5 Figure 5 33 Define Edit User Defined Chemistry Screen Page 2 E011428S EPS ...

Page 174: ... of four alphanumeric characters Identifies unique serial number of UDR cartridge AGXS Limit 1 9999 Identifies Antigen Excess limit rate Comments A maximum of 20 alphanumeric characters Provides additional vendor information or other comments Units Selection from list Concentration Units of UDR results Conversion Factor Not applicable Displays the conversion factor input from the Units option butt...

Page 175: ...µL depending on the sample dilution Sample or dilution volume dispensed to reaction cuvette Reaction Buffer Volume 0 or from 195 µL to 300 µL Reaction buffer volume dispensed Compartment A Volume Refer to Figure 5 34 5 µL to 235 µL Reagent volume aspirated from cartridge compartment A Compartment B Volume Refer to Figure 5 34 0 or from 5 µL to 235 µL Reagent volume aspirated from cartridge compart...

Page 176: ...tridges Compartments A and B 5 Reagent Bar Code Reader 6 Fans 7 Temperature Sensor Table 5 9 Calibration Definition Fields Page 3 Field Entries Allowed Function Levels 4 to 9 Identifies the number of calibrators used in test Replicates 1 to 9 Allows a number of tests to be repeated for each calibration level Update Level 1 to 9 Single point calibration setpoint update level Replicates 1 to 9 Set p...

Page 177: ...nents defined E011419S EPS Table 5 10 Order of Reaction If the Reaction Buffer Volume is and the Compartment B Volume is the Order of Reaction is Between 195 300 µL 0 µL UDR buffer Incubate Neat or Diluted Sample Compartment A Reagent starts reaction Between 195 300 µL Between 5 235 µL UDR buffer Compartment B Reagent Incubate Neat or Diluted Sample Compartment A Reagent starts reaction 0 µL Betwe...

Page 178: ...form UDR AGXS Limit determination testing using UDR Rate Mode 6 Enter UDR AGXS Limit rate value and select check the AGXS Enable box to begin UDR AGXS flagging The AGXS Enable box is located in the Define Edit User Defined Chemistry screen Refer to Figure 5 32 7 Run UDR samples and perform single point UDR calibration updates Step Action 1 From Page 1 of the Define Edit User Defined Chemistry scre...

Page 179: ...for the AGXS Limit in the UDR definition the system will suppress the results and display 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 9 Select the options button beside the Reagent Expiration Date field 10 Enter the reagent expiration date NOTICE The expiration date must not be the current date Reca...

Page 180: ...Step Action 1 From the User Defined Chemistries screen select the chemistry for AGXS flagging Refer to Figure 5 28 2 Select Define Edit 3 A user defined warning message appears Read the message and select OK 4 Select the AGXS Enable box 5 Enter Rate Units into AGXS Limit field 6 Select Save F9 7 If your password is protected then refer to the Password Setup Procedure in this chapter and enter your...

Page 181: ... from 195 µL to 300 µL 7 Enter the volume of reagent to be aspirated and dispensed from Compartment A in the Compartment A Volume field Entries may be from 5 µL to 235 µL 8 Enter the volume of reagent to be aspirated and dispensed from Compartment B in the Compartment B Volume field If the Reaction Buffer Volume field entry is the Compartment B Volume field entry may be 0 195 µL to 235 µL 195 µL t...

Page 182: ...ibration dilution enter the sample dilution in the Sample Dilution field Entries may be from 1 5 to 1 50 OR Enter 1 1 for an undiluted sample 12 Select the options button beside the Reaction Time field 13 Select the reaction time number from the list 14 Select the Page Down button to go to Page 2 of the Define Edit User Defined Chemistry screen 15 Continue to Defining UDR Calibration Information S...

Page 183: ...rom one to nine 3 Enter a Cal Level number in the Update Level field for a single point calibration update Entries may be from one to nine 4 Enter the number of replicates to be run for the Update Level in the Replicates field Entries may be from one to nine 5 Enter the concentration value in each of the Cal Setpoint fields The concentration values must be in ascending order with Level 1 being the...

Page 184: ... chemistry menu 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 Figure 5 36 Delete User Defined Chemistry Dialog Box Ste...

Page 185: ... with the steps below to edit a UDR definition Table 5 11 UDR Editing Function Editing Function Calibration Rack Calibration Status Curve Fit Model Clears calibration programs Cleared Calibrated Cannot Change Clears calibration programs and Cancels the calibration Cleared Uncalibrated Cannot Change Step Action 1 From the Setup screen select 18 User Defined Chemistries 2 Select a number beside a de...

Page 186: ...5 12 below Table 5 12 Editing a UDR Definition Edited UDR Definition Effect on Calibration Effect on AGXS Flagging Comments Serial Number Refill Cartridge No Effect Status Calibrated No Effect Sample Dilution AGXS Limit Clears Program Status Calibrated No Effect All Other Parameters Clears Program Cancels Calibration Status Uncalibrated Clears AGXS Limit Disable Flagging ...

Page 187: ...t more tests are available on the Reagent Calibration Status screen the UDR cartridge may be refilled and reused until the tests remaining is zero Loading UDR Cartridges Follow the instructions in CHAPTER 6 Reagents Calibration Loading Unloading Reagent Cartridges Loading Reagent Cartridges Refilling UDR Cartridges A UDR can be programmed to run a maximum of 300 tests If the cartridge holds less t...

Page 188: ...the Defined Edit User Defined Chemistry screen without refilling the cartridge 8 Refill the cartridge Table 5 13 UDR Cartridge Refill Screen Screen Item Screen Definition Chem Name Chemistry Name as defined in Figure 5 32 Reagent Lot Number Reagent Lot Number as defined in Figure 5 32 Tests per cartridge Tests per cartridge as defined in Figure 5 32 Serial Number Cartridge Serial number as defined...

Page 189: ...tridges IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 89 5 Removing UDR Cartridges Follow the instructions in CHAPTER 6 Reagents Calibration Loading Unloading Reagent Cartridges Removing Cartridges from The Reagent Carousel ...

Page 190: ...4 bottles of UDR sample diluents may be placed on the inner section of the sample carousel Checking UDR Buffer Diluent Status The instrument status must be in Standby in order to proceed with the steps below to check the buffer and diluent status before a run Figure 5 38 Buffer Diluent Status Dialog Box Step Action 1 Select Reagents Cal from the menu bar 2 Select Buffer Diluent F3 Refer to Figure ...

Page 191: ... instructions in CHAPTER 6 Reagents Calibration Loading Clearing Buffers and Diluents Replacing the Same Lot After Loading Buffers and Diluents The system assumes that lot numbers and position numbers for buffers or diluents remain the same from run to run until changed by the user The Remaining volume on the Buffer Diluent Status dialog box is updated during a sample run Clearing a UDR Buffer Dil...

Page 192: ... chemistries 3 Select OK to continue Rate Mode may be run on a calibrated or uncalibrated UDR NOTICE Rate results are always uncalibrated rate whether the UDR is calibrated or uncalibrated OR Select Cancel to exit rate mode and return to the User Defined Chemistry screen 4 From the UDR Rate Mode Assign screen Refer to Figure 5 40 enter an available rack number in the Rack field OR Select Clear Rac...

Page 193: ...6 Page 5 93 5 Figure 5 39 UDR Rate Mode Dialog Box Figure 5 40 UDR Rate Mode Assign Screen 11 Select Main from the menu bar and Run 12 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run Step Action continued 2 of 2 E014049S EPS E014050S EPS ...

Page 194: ...403 Page 5 94 September 2016 Additional Information Refer to CHAPTER 7 Sample Programming Clearing a Sample and Requesting a 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 ...

Page 195: ...the UDR calibration data the system will calculate a final result in the concentration units selected in the protocol Programming a UDR Calibration The instrument status must be in Standby in order to proceed with the steps below to program a UDR calibration Step Action 1 From the User Defined Chemistries screen select Request Cal F4 The UDR chemistries on the reagent carousel will be displayed Re...

Page 196: ...Box Figure 5 42 UDR Multi point Cal Assign Screen 7 Select Save F9 or a menu bar icon to save the calibration program for the displayed chemistry OR Select Cancel F10 to exit the screen without saving any calibration programs 8 Repeat Steps 4 7 to program additional racks for calibration of other UDR chemistries Step Action continued 2 of 2 E014051S EPS E014052S EPS ...

Page 197: ... The UDR chemistries on the reagent carousel will be displayed 2 Select up to six UDR chemistries for calibration 3 Select OK to continue OR Select Cancel to return to the User Defined Chemistries screen 4 From the UDR Cal Assign screen select check the single point update box The predefined update single point level and the Cal ID fields will be enabled Refer to Figure 5 43 5 From the UDR Cal Ass...

Page 198: ...trument status must be in Standby in order to proceed with the steps below to request a UDR load list E011421S EPS Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select UDRCal LdList F6 Refer to Figure 5 44 2 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 Lo...

Page 199: ...n order to proceed with the steps below to run a UDR calibration E011422S EPS Step Action 1 Load the calibration samples in the appropriate racks 2 Select Main from the menu bar and Run 3 Select OK in the Check Dilution Segments dialog box to start the run OR Select Cancel to exit without starting the run 4 When the calibration run is finished a multi point or single point UDR Calibration Results ...

Page 200: ...l request Figure 5 45 UDR Cancel Cal Dialog Box Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select Cancel Request F7 Refer to Figure 5 45 2 Select the requested chemistries to be canceled 3 Select OK to cancel the calibration request The Cal Status of the canceled chemistries will return to the status prior to the calibration request OR Select Cancel ...

Page 201: ...e current calibration rack Figure 5 46 Clear UDR Calibration Racks Dialog Box NOTICE Do not clear a UDR Cal rack until the final curve fit model for the calibration has been selected Step Action 1 From either the User Defined Chemistries screen or the UDR Cal Assign screen select Clear UDR Cal Rack F8 Refer to Figure 5 46 2 Enter the racks to clear in the Rack s field 3 Select OK to clear the rack...

Page 202: ...r the reagent lot numbers defined for this UDR or until another calibration is requested The four models available are First Order Polynomial Second Order Polynomial Third Order Polynomial and Four Parameter Logistic Curve Fit Model Descriptions The following table describes the four curve fit models Refer to Figure 5 47 to Figure 5 53 Table 5 14 Curve fit Models Model Minimum number of calibrator...

Page 203: ...odel Descriptions IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 103 5 Figure 5 47 Example of First Order Polynomial Calibration Figure 5 48 Example of Second Order Polynomial Calibration E014056S EPS E014057S EPS ...

Page 204: ...Model Descriptions System Setup IMMAGE 800 Operations Manual A11403 Page 5 104 September 2016 Figure 5 49 Example of Third Order Polynomial Calibration Figure 5 50 Example of Four Parameter Logistic Calibration E014058S EPS E014059S EPS ...

Page 205: ...urve Fit Model Descriptions IMMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 105 5 Figure 5 51 Example of Composite Calibration Figure 5 52 User Defined Single Point Update Screen E014060S EPS E011423S EPS ...

Page 206: ...axis Instrument responses IR for each calibrator replicate Asterisks Each calibration data point Dotted line Calibration curve Letter U Single point update level NOTICE A Calibration for a UDR reagent may be approved with the status of Incomplete for some of the calibrator samples This calibration will include only the completed replicates for each calibrator level The incomplete replicates will b...

Page 207: ...ct Model F1 to display the curve fit model options Refer to Figure 5 53 5 Select the number beside the model desired and select OK to approve the UDR calibration OR Select Cancel to exit the User Defined Model dialog box 6 Select Print Report F8 to print the data and statistics for a curve fit model 7 Program controls on the UDR through Sample Programming to see if they are acceptable with the cho...

Page 208: ...cale factor Refer to Figure 5 52 The only curve fit model available is the approved multi point calibrated curve fit model Note The letter U appears on the plot at the update level A scale factor is also displayed on the plot window Refer to Figure 5 52 NOTICE After programming and saving a single point calibration request the curve fit model cannot be changed Each single point calibration can onl...

Page 209: ...ibrating a UDR Chemistry in this chapter Refer to the following steps to plot a Robust Means Data Curve Figure 5 54 User Defined Reports Screen Step Action 1 Go to the User Defined Chemistries screen and select a UDR chemistry Refer to Figure 5 28 2 Select Print Plot F10 A User Defined Reports screen appears Refer to Figure 5 54 3 From the User Defined Reports screen select option 6 Plot Robust Me...

Page 210: ... Plotting a Robust Means Data Curve System Setup IMMAGE 800 Operations Manual A11403 Page 5 110 September 2016 Figure 5 55 Plot Robust Means Data Curve Window Figure 5 56 Plot Robust Means Data Curve E011438S EPS E011439S EPS ...

Page 211: ...window appears as shown on Figure 5 57 2 Enter the new starting time and ending time in the Time Range window The new starting ending times must be within the original time range as shown on the initial data curve 3 A new Time Range screen appears that shows the edited times Select OK to plot the new curve and proceed to Step 4 OR Select Default to return to the original curve and time range OR Se...

Page 212: ...t model and associated parameters A calibration report can be printed once a UDR chemistry is defined and before a calibration is requested The printed report will be blank Single Point Update Calibration Results Report Identifies UDR instrument response results per replicate of single point update calibrator for the selected chemistry Single Point Update Calibration Report Identifies UDR mean ins...

Page 213: ...Results Follow the instructions in CHAPTER 8 Results Recall Printing Recalled Results to reprint UDR rate mode and patient results Step Action 1 From the Setup screen select 18 User Defined Chemistries 2 From the User Defined Chemistries screen choose one of the defined UDR positions 3 Select Print Plot F10 to display the report options 4 Select the number beside the report desired 5 Select OK to ...

Page 214: ...2016 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 in this chapter ...

Page 215: ...tions Manual A11403 System Setup September 2016 Page 5 115 5 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 ...

Page 216: ...rations Manual A11403 Page 5 116 September 2016 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 ...

Page 217: ...m Setup September 2016 Page 5 117 5 Instrument Setup Overview Introduction 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 ...

Page 218: ...oduction Two labels must be placed on each rack The labels identify the rack number One label is bar coded the other label is a numbered label Placing the Bar Coded Label on the Rack Place the bar coded rack label on the side of the rack as pictured in Figure 5 58 Figure 5 58 Rack Bar Code Label Placement 1 Rack bar code label A010084P EPS 1 ...

Page 219: ...MMAGE 800 Operations Manual A11403 System Setup September 2016 Page 5 119 5 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 Figure 5 59 Rack Number Label Placement 1 Rack number label A010085P EPS 1 ...

Page 220: ... Introduction The wash solution box and waste container are placed by the instrument in specific locations Wash Solution Box 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 ...

Page 221: ...ing Deleting Reagent Parameters 6 7 Loading Clearing Buffers and Diluents 6 9 Loading Wash Solution 6 13 Loading Unloading Reagent Cartridges 6 14 Calibration 6 17 Overview 6 17 Checking Calibration Status 6 18 Calibration History 6 21 Cartridge Specific Calibration 6 22 Requesting and Canceling Calibration 6 26 Loading Calibrators on the Sample Carousel 6 30 Starting a Calibration Run 6 33 Calibr...

Page 222: ...eptember 2016 Reagents Overview Introduction 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 ...

Page 223: ...describes the headings of the Reagent Status Calibration Status screen for Beckman Coulter chemistries E011425S EPS Table 6 1 Screen Headings Heading Description Pos Position of the reagent cartridge on the reagent carousel Chem Name of chemistry Tests Left Number of tests remaining in the reagent cartridge Lot Lot number of the reagent Serial Number Serial number of the reagent cartridge Cal Stat...

Page 224: ...ent expiration date calibration status calibration date and calibrator lot for all reagents which have had bar code parameters loaded into the database Buffer Diluent F3 Allows set up of buffer or diluent positions on reagent or sample carousel Displays the Remaining volume of buffer or diluent Request Cal F4 Requests calibration of selected chemistries Cal Options F5 Allows the selection of one o...

Page 225: ...ed on the sample carousel at one time Up to 6 different lots of the same reagent or calibrator ID can be stored at one time When more than 6 different lots are scanned the oldest by date of scan is removed from the database Up to 50 different calibrator names can be stored in the database Loading Bar Code Cards The instrument status must be in Standby in order to proceed with the steps below to lo...

Page 226: ...e bar code card is the screen will display successfully read the Rack reagent calibrator Name and Lot for each scanned bar code card in the Cards Read window misread an error message appears with the rack and position where the bar code was misread Refer to CHAPTER 10 Utilities Troubleshooting 9 To exit the Cards Read dialog box even if the bar code read is not finished select OK Step Action conti...

Page 227: ...tus must be in Standby in order to proceed with the steps below to display reagent parameters Figure 6 3 Reagent Summary Dialog Box Step Action 1 Select Rgts Cal from the menu bar 2 Select Reagent Summary F2 Refer to Figure 6 3 3 Select a button beside the Chem lot to be displayed THEN Select the Display button to view the reagent lot parameters OR Select Go To and type the Chem and Lot number 4 S...

Page 228: ...ow to delete reagent parameters Figure 6 5 Delete Reagent Lot Confirmation Dialog Box E010299S EPS Step Action 1 Select Rgts Cal from the menu bar 2 Select Reagent Summary F2 Refer to Figure 6 3 3 Select a button beside the Chem lot to be deleted OR Select Go To and type the Chem and Lot number 4 Select Delete 5 Select OK from the Delete Reagent Lot Confirmation dialog box to delete the parameters...

Page 229: ...on of the sample carousel Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Limits Only one lot number of each buffer type and one lot number of each diluent type may be loaded onto the system at one time Multiple bottles of the same lot can be loaded at different positions When multiple positions are defined for the same buffer or diluent the lot number will be automaticall...

Page 230: ...igure 6 6 3 Select the options button beside the desired position 4 Select the desired buffer or diluent to place in the position Press OK OR Select Cancel to return to the Reagents Status Calibration Status screen without selecting a buffer or diluent 5 Enter the buffer or diluent lot number 6 Repeat steps 3 5 for each buffer and diluent to be loaded 7 Select OK to accept any changes made OR Sele...

Page 231: ...d by the operator The Remaining volume on the Buffer Diluent Status dialog box is updated during a sample run Step Action 1 Mix each buffer or diluent bottle by inversion remove the screw cap 2 Check each container for bubbles and remove bubbles if present 3 Place an evaporation cap on each bottle Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix E Evaporation Cap I...

Page 232: ...eps below to clear a buffer or diluent position Step Action 1 Select Rgts Cal from the menu bar 2 Select Buffer Diluent F3 3 Open the reagent or sample compartment cover 4 Remove the buffer or diluent from the carousel 5 Close the reagent or sample compartment cover 6 Select the options button beside the position to be cleared 7 Select Clear to clear the position OR Select Cancel to return to the ...

Page 233: ... status must be in Standby in order to proceed with the steps below to load the wash solution Step Action 1 Remove the screw cap with the tubings and straw attached from the wash solution container in use 2 Remove the screw cap from the new container of wash solution 3 Place the cap with the tubings and straw attached into the new wash solution and screw on the cap The blue tubing is attached to t...

Page 234: ...ith the steps below to load the reagent cartridge s Step Action 1 Select Rgts Cal from the menu bar 2 Invert each cartridge gently before removing screw caps Remove the screw caps from the cartridge s Check each compartment for bubbles and remove bubbles if present Place evaporation caps on each cartridge compartment Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix...

Page 235: ...rtridge read and go to Step 8 OR Select Cancel to return to the Reagent Status Calibration Status screen without reading the reagent cartridges 8 If the screen will display the load is successful updated reagent status information the load is unsuccessful an error message Refer to CHAPTER 10 Utilities Troubleshooting the cartridge is expired a warning message the cartridge is exhausted Tests Left ...

Page 236: ...he Reagent Carousel The instrument status must be in Standby in order to proceed with the steps below to remove reagent cartridges from the reagent carousel Step Action 1 Open the reagent compartment cover 2 Lift the reagent carousel from the center and remove 3 Store the loaded reagent carousel in the refrigerator No software intervention is required Step Action 1 Open the reagent compartment cov...

Page 237: ...er 2016 Page 6 17 6 Calibration Overview Introduction This section explains the following topics Checking Calibration Status Requesting and Canceling Calibration Loading Calibrators on the Sample Carousel Starting a Calibration Run Calibration Results Re enabling Calibration Cal Options ...

Page 238: ...rtridges Table 6 3 Calibration Status Terms Term Explanation Uncalibrated the reagent has never been calibrated Calibrated the reagent is calibrated Requested calibration is requested Cal Failed calibration failed Cal Re enabled the previous calibration is re enabled Step Action 1 Place reagent cartridges on the reagent carousel and read the cartridge bar codes Refer to Reagents Loading Unloading ...

Page 239: ...25S EPS Step Action 1 From the Reagent Status Calibration Status screen select Reagent Summary F2 Refer to Figure 6 8 2 Verify the calibration status under the Cal Status heading for the desired reagent 3 For further information about the reagent complete the following steps From the Reagent Summary dialog box select a button beside a desired reagent THEN Select the Display button to view the reag...

Page 240: ...libration Status Verifying the Cal Status of Reagent Parameters in the Database Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 20 September 2016 Figure 6 9 Reagent Summary Dialog Box E010239S EPS ...

Page 241: ...ost recent calibration failed and there was a previous successful calibration the user has the option to re enable the previous calibration Step Action 1 Select Rgts Cal icon 2 From the Reagent Status Calibration Status screen select the pull down on the Cal ID field to display the Calibration History window Refer to Figure 6 1 3 The calibrations display ascending date time order with the oldest c...

Page 242: ...ication Reagent cartridge on carousel contains less than predetermined number of tests remaining Calibration is requested for a specific chemistry Cartridge Specific Calibration Terms Term Explanation Reagent Lot Calibration of a fresh cartridge to be applied to all cartridges with the same lot number Cartridge specific Calibration of a partially used cartridge to be applied to that cartridge only...

Page 243: ... uses the cartridge loaded at the lowest carousel position all the cartridge specific calibration criteria are met when a calibration is requested the system automatically runs a cartridge specific calibration on the appropriate cartridge Step Action 1 From the Reagent Status Calibration Status screen select the options button beside Cal ID for the desired chemistry 2 View the Calibration Informat...

Page 244: ...in the same calibration status prior to the request additional cartridges of the same lot with greater than the predetermined number of remaining tests are loaded on the system those cartridges maintain the reagent lot calibration the calibration is successfully completed the Cal Status of that cartridge goes to Calibrated a new cartridge specific calibration is applied the reagent lot calibration...

Page 245: ...ber of tests remaining remove cartridge specific cartridge place a fresh cartridge on carousel request and recalibrate chemistry replace used cartridge on carousel after successful calibration specific calibration information is desired select the options button beside Cal ID for the calibrator of the specific chemistry The Calibration Information screen will indicate whether the calibration was c...

Page 246: ...low the steps below to request calibration Step Action 1 Select Rgts Cal from the menu bar 2 Load the reagent cartridges if necessary Refer to Reagents Loading Unloading Reagent Cartridges in this chapter 3 Select the button s to the left of the chemistries to be calibrated If selecting a chemistry where more than one cartridge of the same lot number is on the reagent carousel each cartridge of th...

Page 247: ...sition used for a calibrator must be Available before it is used for calibration Follow the steps below to check the rack status and clear racks E010236S EPS Step Action 1 On the Request Calibration screen check the Available Racks section to see if the rack to be used is Available Available racks have at least one position that is not programmed 2 If the rack is Not Available select Clear Racks F...

Page 248: ...ber is entered all positions on the rack are automatically cleared more than one rack number is entered all positions on each rack are automatically cleared the Pos s field cannot be accessed 4 Select OK to clear the racks and positions OR Select Cancel to return to the Reagent Status Calibration Status screen without clearing 5 If the calibrator sample is then bar coded Select Save F9 to save the...

Page 249: ...creen type the Available rack and position for the calibrator in the Rack and Position fields 2 Select the options button beside the desired position for the calibrator 3 From the Calibrator Lots dialog box select the appropriate calibrator lot number OR Select Cancel to return to the Request Calibration screen without selecting a calibrator lot number 4 Select Save F9 to save the calibration requ...

Page 250: ...escription Sample Container Information for various test tube and sample cup sizes and instructions for applying bar code labels Note The labeled test tube should be saved for re use 3 Place the tube into a sample rack 4 Place the appropriate sample cup in the labeled test tube 5 Place the appropriate calibrator in the sample cup 6 Repeat steps 1 5 for any additional calibrators Continue placing c...

Page 251: ... return to the Reagent Status Calibration Status screen Refer to APPENDIX B Reports for an example printout Step Action 1 According to the Cal Load List place a test tube into the appropriate rack and position 2 Place the appropriate sample cup in the test tube 3 Place the appropriate calibrator in the sample cup 4 Repeat steps 1 3 for any additional calibrators Continue placing calibrators into t...

Page 252: ...ontrols Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 32 September 2016 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 E010241S EPS ...

Page 253: ...are placed into position the calibration run is started Starting a Calibration Run Follow the steps below to start the calibration 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 Step Action 1 Select Main from the...

Page 254: ...ition STAT Rerun flags Instrument Errors Codes Calibrated to Value Calibration Time Limit No time limit is imposed by the system for expiration of a calibration result Recalibration of affected reagents may be necessary when reaction buffer or diluent lots are changed Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual After Calibration Rack positions used for calibration are ...

Page 255: ...abled 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 Step Action 1 Select Rgts Cal from the menu bar 2 Select the options button to the right of the Cal ID of the failed calib...

Page 256: ... in order to follow the steps below to display calibrator lot parameters Figure 6 13 Calibrator Summary Dialog Box Step Action 1 Select Rgts Cal from the menu bar 2 Select Cal Options F5 3 Select 1 Calibrator Summary Refer to Figure 6 13 4 Select a button beside the Calibrator to be displayed THEN Select the Display button to view the calibrator lot parameters Refer to Figure 6 13 OR Select Go To ...

Page 257: ...tor parameters E010301S EPS Step Action 1 Display the Calibrator Lot Display dialog box for the calibrator that is to be printed Refer to Displaying Calibrator Lot Parameters 2 Select Print to print the calibrator lot parameters OR OK to return to the Calibrator Summary Dialog box Step Action 1 Select Rgts Cal from the menu bar 2 Select Cal Options F5 3 Select 1 Calibrator Summary Refer to Figure ...

Page 258: ... follow the steps below to restore the default slope and offset adjustments 5 Select OK from the Delete Calibrator Lot Confirmation dialog box to delete the parameters OR Cancel to return to the Calibrator Summary dialog box without deleting parameters Step Action continued 2 of 2 Step Action 1 Select Rgts Cal from the menu bar 2 Select Cal Options F5 3 Select 2 Slope Offset Adjustment 4 Select th...

Page 259: ...ffset Adjustments IMMAGE 800 Operations Manual A11403 Reagents Calibration September 2016 Page 6 39 6 Printing Slope and Offset Adjustments From the Slope Offset screen select Print F10 to print all of the slope and offset adjustments ...

Page 260: ...Cal Options Printing Slope and Offset Adjustments Reagents Calibration IMMAGE 800 Operations Manual A11403 Page 6 40 September 2016 ...

Page 261: ...20 Entering a Sample Comment 7 22 Entering a Patient ID 7 24 Entering Patient Demographics 7 25 Selecting Sample Options 7 28 Selecting Replicates 7 29 Antigen Excess AGXS Testing 7 30 Selecting Non Standard Dilutions 7 31 Entering an Off line Dilution Factor 7 33 Linking Unlinking Samples 7 35 Setting Variables 7 37 Programming a Control 7 38 Programming a STAT 7 43 Selecting Save Next 7 44 Progr...

Page 262: ...Post run Summary 7 69 Overview 7 69 Requesting a Load List 7 70 Requesting a Post run Summary 7 75 Clearing a Sample 7 76 Overview 7 76 Clearing a Sample by Sample ID 7 77 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 Dis...

Page 263: ...ples and or starting a run all racks to be used must have a status of Available If the status of a rack is not Available the rack must be cleared before it can be used for programming samples 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 ...

Page 264: ... Samples from the menu bar 2 Select Load List F9 3 Type the rack numbers s to be checked in the Rack s field up to 15 alphanumeric characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 4 Select Display If a Load List cannot be displayed for a requested rack the rack is Available Step Action 1 Select Samples from the menu bar 2 Select Clear Samples F...

Page 265: ...ed the rack status becomes Available associated sample programs and results remain in the database Both can be accessed through Results Recall by any option except Rack and Position Additional Information 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 ...

Page 266: ...ed with unused segments on the sample carousel Checking Status and Clearing Segments The instrument status must be in Standby in order to proceed with the steps below to check the status of the dilution segments After Clearing Segments Always replace the cleared dilution segments with unused segments on the sample carousel before a run is started Step Action 1 Select Status from the menu bar 2 Sel...

Page 267: ... 11 System Status Instrument Commands for more information on Dilution Segments status Step Action 1 Lift the cover of the sample carousel 2 Rotate the sample carousel by pressing the advance button in order to access the desired dilution segment if necessary 3 Lift the segment to be replaced off of the sample carousel Refer to Figure 7 1 4 Dispose of the used segment in a manner appropriate for b...

Page 268: ... Status Follow the steps below to check the status of buffers and diluents Step Action 1 Select Rgts Cal from the menu bar 2 Select Read Reagents F1 to update the status information if reagent cartridges were loaded or removed since the last run 3 Determine if the chemistries on the carousel and the number of tests remaining are appropriate for the run Note any chemistries that require calibration...

Page 269: ...wever the box should be replaced as soon as possible Checking Wash Solution Follow the steps below to check the wash solution volume Step Action 1 Visually inspect the wash solution level through the perforated cut outs at the top of the box and or lift and swirl the box 2 Replace the box if the wash solution volume does not appear sufficient to complete the run Refer to CHAPTER 6 Reagents Calibra...

Page 270: ...ample description which consists of sample type sample comment patient ID and patient demographics sample options which consist of sample replicates test replicates off line dilution ratio antigen excess testing non standard dilutions and linking samples control samples STAT samples Additional Information Refer to CHAPTER 2 System Description Sample Container Information Sample Containers Allowed ...

Page 271: ...llowing table decribes each status and which sample programming fields or functions are accessible while the status is displayed E010252S EPS Table 7 1 Sample Status Status Description Accessible Fields Functions Not Programmed Sample is not programmed or saved All Sample Required Sample program is saved All Waiting to Run The sample carousel was scanned and the sample program is recognized by the...

Page 272: ...mple Status continued Status Description Accessible Fields Functions 2 of 2 Table 7 2 Working Area Functions Section Functions Upper Allows entry of the following information associated with a sample Rack Position Sample ID STAT Designation Sample Type Patient ID Sample Comment Patient Name can only be accessed through Demographics Middle Allows the selection of panel numbers and or chemistry numb...

Page 273: ...patient demographic information Sample Options F3 Allows the selection of sample or chemistry replicates off line or non standard dilutions antigen excess testing and linking samples Program Batch F4 Allows a sample program to be automatically repeated for multiple samples Program Control F5 Allows the selection of a control from a pre defined list Rerun Samples F6 Allows the selection of samples ...

Page 274: ... one chemistry Assigning a Rack and Position Follow the steps below to assign a Rack number and Position number Entering a Sample ID Follow the steps below to enter a Sample ID NOTICE A Rack number and Position number must be assigned if a sample is not bar coded or if a sample bar code is unreadable Step Action 1 Select Samples from the menu bar 2 Choose the Rack field if the cursor is in another...

Page 275: ... be reused by rerunning the sample The original and rerun results will be collated Example A sample is programmed for tests A and B Test B requires pretreatment of the sample The untreated sample can be run first for test A and the pretreated sample can then be rerun for Test B only OR clearing the Sample ID and reprogramming it The original and reprogrammed Sample IDs will be treated as two diffe...

Page 276: ...s defined using previous versions of software and restored to version 1 5 will have a sample type of Unknown Panels having a sample type of Unknown cannot be used in Sample Programming Refer to CHAPTER 5 System Setup Panel Setup Editing Panels to edit a sample type Step Action 1 Select Samples from the menu bar 2 From the Program Sample screen choose the Panel No s field 3 Type the desired panel n...

Page 277: ...ill be displayed any off line or non standard dilution defined for the panel will be applied Canceling a Panel A selected panel can be canceled by deselecting it in the Panels list The highlight will be removed 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 pa...

Page 278: ...ollow the steps below to select a chemistry by number Selecting a Chemistry from Chemistry Menu Follow the steps below to select a chemistry from the chemistry menu After Chemistry Selection After a chemistry is selected the button is highlighted in the chemistry menu Step Action 1 Select Samples from the menu bar 2 Choose the Chem No s field 3 Type the desired chemistry number s in the Chem No s ...

Page 279: ...7 19 7 Canceling a Chemistry A selected chemistry can be canceled by deselecting the button from the chemistry menu The highlight is removed 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 ...

Page 280: ...Type Follow the steps below to select a 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 NOTICE If a sample type is selected that is not applicable to specific chemistries those chemistries are unavailable and appear dimmed on the chemistry menu Step Action 1 Select Samples from the menu bar 2 Sele...

Page 281: ...meters Dialog Box Additional Information Refer to CHAPTER 5 System Setup Default Setup for more information on defining a default Sample Type Step Action 1 Type the urine volume in milliliters 1 99999 0 and press Enter 2 Enter the total time in which the urine was collected Type the number of hours 0 99 and press Enter Type the number of minutes 0 59 and press Enter 3 Select OK to program the urin...

Page 282: ...e Comment list Refer to Figure 7 5 Only one comment can be selected for a sample After a comment is selected it can be edited in the Sample Comment field Figure 7 5 Sample Comment Dialog Box Step Action 1 Select Samples from the menu bar 2 To select comment from list To enter comment number Select the options button beside the Sample Comment field AND Type the number of the desired comment and pre...

Page 283: ...ng a Comment Follow the steps below to enter a Sample Comment Additional Information Refer to CHAPTER 5 System Setup Sample Comments Setup for more information on defining a list of Sample Comments Step Action 1 Select Samples from the menu bar 2 Choose the Sample Comment field 3 Type a Sample Comment up to 25 alphanumeric characters ...

Page 284: ...ng a Patient ID Follow the steps below to enter a Patient ID Table 7 4 Patient ID Field If and then a Patient ID is entered along with demographic information for a sample the same Patient ID is entered later for a new sample the demographic information will be displayed automatically for the new sample the patient name will appear in the Patient Name field Step Action 1 Select Samples from the me...

Page 285: ...each sample Select Demog F2 to access the Demographics screen The upper section of the Program Sample screen also appears on the Demographics screen 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 Figure 7 6 Demographics Screen E0...

Page 286: ...umeric characters Patient ID may be entered from the Program Sample screen Name Last name 18 alphanumeric characters First name 15 alphanumeric characters MI Middle Initial 1 alphabetic character Date of Birth mm 1 12 dd 1 31 yyyy 1850 2035 The order and the separator character are defined in Setup Sex Select the options button beside the Sex field Select an option from the list The options are Ma...

Page 287: ...ters Collection Date mm 1 12 dd 1 31 yy 0 99 The order and the separator character are defined in Setup The default date is the current date Collection Time 24 hour format hh 0 23 mm 0 59 The time format is defined in Setup as 12 hour or 24 hour The separator character is defined in Setup Collection Time 12 hour format hh 1 12 mm 0 59 AM PM Select the options button beside the Collection Time fiel...

Page 288: ...es for an entire sample or for individual tests the enabling or disabling of antigen excess testing the selection of non standard dilutions the entering of an off line dilution factor the linking and unlinking of two samples for a calculation the setting of variables for use in Custom Calculations Figure 7 7 Sample Options Dialog Box Exiting the Sample Options Dialog Box Select OK to save the info...

Page 289: ...efines the number of times an individual test will be repeated 1 9 test replicates are available It applies only to the current sample Entering Sample Replicates Follow the steps below to enter a Sample Replicate number Entering Test Replicates Follow the steps below to enter a test replicate number Additional Information Refer to CHAPTER 5 System Setup Default Setup for more information on defini...

Page 290: ...ditional Information 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 Table 7 6 AGXS Testing When the check box is AGXS testing is And on the Program Sample screen checked enabled for the chemistry Every time th...

Page 291: ...le Options dialog box it will remain selected if the Non Standard Dilution dialog box is displayed again for the same sample If antigen excess testing is enabled for a chemistry it will still be performed when a Non Standard Dilution is selected Sample programming from a host computer assumes the default starting dilution for each chemistry A Non Standard Dilution can be selected by editing the sa...

Page 292: ...on Standard Dilution list Step Action 1 Change the Sample Type if different from the default Sample Type Refer to Selecting a Sample Type in this chapter 2 Select the chemistry desired 3 Select Sample Options F3 from the Program Sample screen 4 Select the options button in the Non Standard Dilution column that is beside the desired chemistry 5 Type the number of the desired dilution and press Ente...

Page 293: ... of the analyte being assayed the user must know the Default Dilution and appropriate diluting fluid for the analyte Find the Default Dilution and diluting fluid for IGA in IMMAGE Immunochemistry Systems Chemistry Information Manual APPENDIX B Measuring Ranges Dilution Fluids The Default Dilution for IGA is 1 36 The diluting fluid for IGA is DIL1 Prepare the Default Dilution for the analyte being ...

Page 294: ...otal parts of diluent sample 1 01 9999 99 and press Enter CAUTION If a non standard or off line dilution is selected a condition of antigen excess could exist which may not be detected by the 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...

Page 295: ...e Sample Program screen to link two samples Figure 7 9 Link Samples Dialog Box Step Action 1 Program one of the samples to be linked Select Save Next F10 2 Enter a Sample ID select chemistries and program any additional information for the other sample to be linked 3 Select Sample Options F3 4 Select Link Samples Refer to Figure 7 9 5 Type the Sample ID of the saved sample to be linked to the samp...

Page 296: ...ering the Sample ID in the Program Sample screen 2 Select Sample Options F3 3 Select Link Samples 4 Select Unlink Samples 5 Select OK to unlink the samples and return to the Link Samples dialog box OR Select Cancel to return to the Link Samples dialog box without unlinking the samples Step Action 1 Load the linked samples onto the instrument 2 Select Main from the menu bar AND Select Run 3 Select ...

Page 297: ...nformation Refer to CHAPTER 5 System Setup Calculations Setup for more information on special calculations Step Action 1 Select the desired chemistry ies from the Program Sample screen 2 Select Sample Options F3 3 Select Set Variables 4 Select an options button from the Set Variables dialog box 5 Select the number beside the desired variable OR Enter the number of the desired variable in the Optio...

Page 298: ...ring batch programming of patient samples Control IDs Control IDs like Sample IDs must be unique for each sample within a run Control Batch F1 cannot be accessed when control definitions do not include Control IDs Sample Control IDs must be used when programming controls in batch Control IDs unlike Sample IDs can be reused after the control sample is run When the sample status of a Control ID is C...

Page 299: ...be used to identify control samples The bar code must encode a defined Control ID If the same control is repeated in different positions during a run each control sample must have a different bar coded Control ID All defined control chemistries will be run automatically when a Control ID is identified by bar code Exception the system will try to run Pending tests from an Incomplete sample When usi...

Page 300: ...rol ID field to select a Control ID A Control ID is optional NOTICE If a control is programmed with a Control ID and the host sends a patient sample with an ID identical to the control the programmed control will be deleted 4 Select or deselect panels and or chemistries if necessary Select Clear Chems F7 to deselect all chemistries Refer to Selecting Chemistry Tests by Panel and Selecting Chemistr...

Page 301: ...rol Programming a Non bar Coded Control IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7 41 7 Figure 7 10 Select Control Dialog Box Figure 7 11 Program Control Screen E010259S EPS E010260S EPS ...

Page 302: ...ed to select a control Additional Information Refer to CHAPTER 9 Quality Control Defining a Control for more information on defining controls Table 7 7 Alternative Methods of Selecting Controls Method If then 1 the Control ID is known type the Control ID in the Sample ID field of the Program Sample screen 2 the Rack and Position of a completed control is known type the Rack and Position number in ...

Page 303: ...d Position numbers A STAT calibration is run before a STAT sample A STAT calibration must be programmed when the calibration is requested If multiple STAT samples are programmed they will be run in the order they are placed around the sample carousel in a counter clockwise direction Programming a STAT Sample Follow the steps below to program a STAT sample Additional Information Refer to CHAPTER 6 ...

Page 304: ...ted without selecting Save Next F10 Automatic Incrementing If a Rack number and Position number are entered for the current sample selecting Save Next F10 will automatically increment to the next position within the rack according to the following guidelines Selecting Save Next F10 from the last position on a rack will display a blank Program Sample screen Table 7 8 Automatic Incrementing If the n...

Page 305: ...idual samples within the batch Entering a Batch Program Follow the steps below to enter a sample program to be applied to a batch of samples Step Action 1 Select Samples from the menu bar 2 Select chemistries from the Program Sample screen Refer to Programming a Sample Selecting Chemistry Tests by Panel and Selecting Chemistry Tests by Chemistry in this chapter for more information 3 Select Sample...

Page 306: ...ode Priority is disabled Identifying Batch Samples Bar Code Priority Enabled Follow the steps below to identify which samples are to be included in a batch if bar code priority is enabled in Setup Figure 7 12 Program Batch Screen Bar Code Priority Enabled Step Action 1 Select Program Batch F4 when all information to be applied to the batch is programmed 2 Type the Sample ID for each sample in the ...

Page 307: ...e 7 13 If the racks are then listed as available Press Enter and proceed to Step 3 not listed as available Type the rack numbers that need to be cleared Select Clear Racks AND Select OK to confirm the racks and repeat Step 2 for available racks OR Select Cancel to return to the Select Clear Racks dialog box without clearing the racks 3 Type the number of samples to be included in the batch This nu...

Page 308: ...l A11403 Page 7 48 September 2016 Figure 7 13 Select Clear Racks Dialog Box 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 E010261S EPS E010262S EPS ...

Page 309: ...d after the batch samples are identified Editing can include entering patient demographic information Follow the steps below to edit an individual sample within a batch Step Action 1 Select Samples from the menu bar 2 Type the Rack number and Position number OR Type the Sample ID of the desired sample 3 Edit the desired information for the sample 4 Select Save Next F10 5 Repeat Steps 2 4 to edit a...

Page 310: ...mine in which rack and position to place sample containers If the sample container Then is bar code labeled Samples may be placed in any position of any rack of the proper size no Load List is required is not bar code labeled Select Samples from the menu bar Select Load List F9 from the Program Samples screen Type the number s of the rack s programmed for the samples to be processed and Print or d...

Page 311: ...verify that each container is placed into a rack which matches the container size four rack sizes are available 13 75 mm 13 100 mm 16 75 mm and 16 100 mm seated in the depression at the bottom of the rack and 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 Step Action continued 2 of 3 ...

Page 312: ...dby Place the sample rack in any position on the sample carousel Notes Position the rack so that both rack pegs 2 slide into holes in the carousel 1 3 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 Step Action continued 3 of 3 ...

Page 313: ... to appropriate sections of this guide for instructions on how to perform each task Perform daily maintenance Check status of dilution segments clear and replace if necessary Check status of reagent cartridges load if necessary Check status of reaction buffers and sample diluents replace if necessary Check sample rack status clear racks if necessary Check calibration status calibrate if necessary ...

Page 314: ...are on the sample carousel and the run is ready to be processed follow the steps below Step Action 1 Close the covers 2 Select Main from the menu bar 3 Select Run 4 Select OK if dilution segment status is OK AND Observe the instrument occasionally during the first 5 minutes of operation to respond to any messages that might be displayed ...

Page 315: ... Run Overview Introduction When the system is running the user may select the pause option to load samples without waiting for the entire system to complete all actions 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 ...

Page 316: ...s in process and goes into Standby after the pause Figure 7 17 Request Pause Screen Canceling a Pause Request Select the Cancel button to cancel the pause request This will not affect the current run Refer to Figure 7 17 Restarting a Run Select the RUN button to restart the paused run Step Action 1 During the run select Pause at the main screen 2 Select System Pause at the Request Pause screen Ref...

Page 317: ...rations or let the system pause to Standby Pausing Load Samples Step Action 1 Program new samples on a rack that is not on the system 2 During the run select Pause from Main screen It is recommended not to pause the system during calibration because it may result in a calibration failure 3 Select Load Samples at the Request Pause screen Refer to Figure 7 17 Note that the status screen shows Pausin...

Page 318: ... load samples NOTICE The amount of time to load new samples and to resume the run depends on the number of samples being processed If a small number of samples are being processed there may not be enough time to resume the run In this case the sytem will return to Standby Select RUN to restart the system 6 Go the the Main screen and select RUN The system status will change to Resuming and Run CAUT...

Page 319: ...ies the sample wheel and automatically returns to the running state If the user resumes operations after the system goes to Standby the system reinventories the sample wheel and returns to a running state Incomplete samples requiring additional dilutions continue processing at the next required sample dilution Dilutions created before selecting Pause will not be reused In some instances the system...

Page 320: ...new run must be started Several options are available when rerunning samples The original sample programs can be edited before rerunning The original sample programs can be rerun Selected chemistries can be rerun for a group of samples The initial dilution made in the dilution well can be reused The default is to remake a dilution Rerun Results When tests are rerun The rerun results replace the or...

Page 321: ...l A11403 Sample Programming September 2016 Page 7 61 7 Selecting Samples to be Rerun Introduction 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 Figure 7 19 Rerun Samples Dialog Box E010267S EPS ...

Page 322: ...al Sample IDs the Sample IDs for rerun in the Sample ID s field up to 43 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric Sample IDs the individual Sample IDs to be rerun in the Samp...

Page 323: ...os s field Type the position numbers desired for rerun up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack number is entered All positions on each rack are automatically selected The Pos s field cannot be accessed A sample in ...

Page 324: ...g Programs Before Rerun Step 3 This option can be useful when sample volume is limited Reuse Dilution cannot be used if the necessary dilution segments were cleared or removed from the sample carousel If Reuse Dilution is selected and there is not enough diluted sample available in the dilution well the dilution will be remade in a new well Note The default is to remake a dilution Clear Chems Opti...

Page 325: ...to Rerunning a Sample Selecting Samples to be Rerun in this Section for more information 2 Select Edit Samples 3 Perform any of the following Refer to Figure 7 20 Edit the desired sample program information Refer to Programming a Sample in this chapter for more information Select Reuse Dil F4 to reuse the original dilution Select OK to confirm Select Clear Chems F8 to clear all original chemistry ...

Page 326: ...n original sample programs are rerun The Reuse Dilution option is only available through Edit Samples Rerunning Original Programs Follow the steps below to rerun original sample programs Step Action 1 Select Rerun Samples F6 from the Program Sample screen and select samples to be rerun Refer to Rerunning a Sample Selecting Samples to be Rerun in this section for more information 2 Select Rerun Sam...

Page 327: ...stry is only available through Edit Samples Selecting Chemistries for Rerun Follow the steps below to select chemistries to be rerun Figure 7 21 Rerun Chem Dialog Box Step Action 1 Select Rerun Samples F6 from the Program Sample screen and select samples to be rerun Refer to Rerunning a Sample Selecting Samples to be Rerun in this section for more information 2 Select Rerun Chem 3 Select the chemi...

Page 328: ...f the control sample has been run and then is not bar coded all chemistries defined for the control may be rerun Go to Step 2 has completed results and is bar coded all chemistries defined for the control may be rerun Go to Step 3 has incomplete results and is bar coded only the incomplete chemistries defined may be rerun Go to Step 3 2 Enter the rack and position of the previously run non bar cod...

Page 329: ... any time A Load List contains the following information for each sample when applicable Rack Position Sample ID Patient Name Sample Type Off line Dilution Factor Chemistries including replicates Sample status STAT designation Rerun designation 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...

Page 330: ... 2016 Requesting a Load List Introduction A Load List can be requested by one of the following options Sample ID and or a range of Sample IDs Rack Position Date Time Sample Status When a Load List is requested it can be displayed and or printed Refer to Figure 7 22 Figure 7 22 Load List Dialog Box E010264S EPS ...

Page 331: ...l Sample IDs the Sample IDs desired for the Load List in the Sample ID s field up to 43 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric Sample IDs the individual Sample IDs to be re...

Page 332: ...mbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 3 If then one rack number is entered Press Enter to access the Pos s field Type the position numbers desired for the Load List up to 15 alphanumeric characters Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on...

Page 333: ...mm 1 12 dd 1 31 yy 0 99 If only a From date is entered the load list be requested for the 24 hour period of that date The order and the separator character are defined in Setup Time From and To 12 hour format hh 1 12 mm 0 59 AM PM Select the options button beside the AM PM field Select AM or PM A time entry is optional If only a date is entered the load list will be requested for the each 24 hour ...

Page 334: ...le of a printed Load List Displaying a Load List After an option to request a Load List is entered the Load List can be displayed by selecting Display The Load List screen will appear Refer to Figure 7 23 Page Up and Page Down buttons appear when a displayed Load List covers more than one screen A displayed Load List can also be printed from the Load List screen by selecting Print F10 Figure 7 23 ...

Page 335: ...emarks The operator has the option to choose the time frame for the Post Run Summary report The Post Run Summary Time Search includes None 12 Hour 24 Hour 48 Hour 72 Hour Accessing the Post Run Summary Follow the steps below to access the Post Run Summary Setting the Post Run Summary Time Limit Refer to CHAPTER 5 System Setup Default Setup Setting the Default Post Run Summary Time Search Step Acti...

Page 336: ...stored in the database When a sample is cleared by Sample ID the associated Position on the Rack becomes available for programming the Sample ID can be reused the Sample Program cannot be recalled by Rack and Position or Sample ID When a sample is cleared by Rack and Position the associated Position on the Rack becomes available for programming the Sample ID cannot be reused the sample program can...

Page 337: ...ple ID s field up to 42 characters spaces are not allowed Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field a range of alphanumeric Sample IDs the individual Sample IDs to be cleared in the Sample IDs field separated by a comma all Sample ID...

Page 338: ...d or by a dash as a range 3 If then one rack number is entered Press Enter to access the Pos s field Type the position numbers desired to be cleared up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Example 1 2 5 8 Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack number is...

Page 339: ...ld 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 Action 1 Check and clear as necessary sample racks Check clear and replace as necessary dilution segments Check reagents buffers and diluents wash solution volume Refer to Preparing for Programming...

Page 340: ...ons If a bar coded tube with a host query is run in a position previously manually programmed the position will not automatically clear A conflict warning message will display If samples are then bar coded load samples in any rack and position not bar coded program rack and position and sample ID for each sample Load samples in the programmed racks and positions Refer to Programming a Sample in th...

Page 341: ...ash solution volume Refer to Preparing for Programming Running in this chapter 2 Request calibrations if necessary Refer to CHAPTER 6 Reagents Calibration 3 Send sample programming from the host computer according to the laboratory s procedure 4 If samples are then bar coded load samples in any rack and position not bar coded load samples in racks and positions assigned by the host Refer to CHAPTE...

Page 342: ... in this chapter 2 Request calibrations if necessary Refer to CHAPTER 6 Reagents Calibration 3 If samples are then bar coded program sample ID chemistries and any additional information needed for each sample Load samples in any rack and position not bar coded program rack and position sample ID chemistries and any additional information needed for each sample Load samples in the programmed racks ...

Page 343: ...s Host Setup Message Status None Host off 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 Host Down IMMAGE 800 is unable to communicate with the host but is still trying Bidirectional with Host Query Host Up I...

Page 344: ...Data output in Japanese including printer output of reports and results Host interface with the Laboratory Information System LIS to transfer Japanese characters A basic Kanji character dictionary and an expanded dictionary to include additional Kanji characters for names places and technical medical terms Pop up messages including error messages are displayed in mixed scripts of Kanji Hiragana Ka...

Page 345: ...igure 7 25 IMMAGE 800 Japanese Keyboard Keyboard Entry Data may be entered from the keyboard in the following writing modes Eigo Zenkaku1 Eigo Hankaku2 Hiragana Katakana Zenkaku1 Katakana Hankaku2 Kanji Translation from Romaji to Hiragana conversion The following writing modes and character widths may be selected from field to field or screen to screen English Full width or half width E015150L EPS...

Page 346: ...layed on the screen The character width and type mode symbol are displayed in the lower right corner of the screen To switch from Japanese entry mode to English entry mode Roman press the Shift Caps Locks keys at the same time To return to Hiragana press the Katakana Hiragana key To change from Hiragana to Katakana press the Shift Katakana Hiragana keys at the same time To return to Hiragana press...

Page 347: ...nese characters are only available from the Japanese keyboard provided Japanese words are entered in Romaji for translation to Hiragana Katakana and or Kanji Screens and Fields The screens and fields available for text entry of Japanese characters are Main Sample Program Screen Refer to Figure 7 26 Sample Comment Figure 7 26 Sample Programming Screen J015148S EPS ...

Page 348: ...e 7 27 Sample Comment Patient Last Name First Name MI1 Patient Comment Physician Name Location Collected By Figure 7 27 Patient Demographic Screen 1 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 J010256S EPS ...

Page 349: ...28 Patient Last Name First Name MI1 Figure 7 28 Recall Results Screen Setup Sample Comments Screen Refer to Figure 7 29 Figure 7 29 Sample Comments Screen 1 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 J010229S EPS ...

Page 350: ...creens and Fields Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 90 September 2016 Report Setup Screen Refer to Figure 7 30 Facility Name Facility Address Attention Person Figure 7 30 Report Setup Screen ...

Page 351: ...try in Romaji is converted to the equivalent Hiragana sequences for the Kanji word The Hiragana sequence converted from Romaji will be highlighted with a blue background for translation to Kanji characters The SPACE BAR is used to display the Kanji candidates The first time the SPACE BAR is pressed the Hiragana sequence for the Kanji word is replaced with the first Kanji character s choice from a ...

Page 352: ...er 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 The candidate Kanji character s displayed in the text field is highlighted with yellow until it is approved inserted by the user The candidate Kanji character s is entered into text when the ENTER key is pressed or the sel...

Page 353: ...igure 7 31 Figure 7 31 Display Events Dialog Box English characters appear where Japanese characters are not appropriate such as Reagent Name or Control Name Reagent Buffer or Diluent Lot Number Calibration ID Sample ID Patient ID Control ID Button Function Label or Abbreviation Reports and Summaries are displayable and printable in mixed scripts of Japanese and English characters These include bu...

Page 354: ...esults 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 Databases stored archived in other languages are retrievable in the Japanese language mode but not translated Kanji characters from the main Kanji dictionary are retrieved automatical...

Page 355: ...e 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 For further information refer to IMMAGE Immunochemistry Systems Host Interface Specifications Revi...

Page 356: ...ion Interface Hiragana Conversions From Romaji Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 96 September 2016 Hiragana Conversions From Romaji Figure 7 32 Hiragana Conversions From Romaji J015152L EPS ...

Page 357: ...on Interface Katakana Conversions From Romaji IMMAGE 800 Operations Manual A11403 Sample Programming September 2016 Page 7 97 7 Katakana Conversions From Romaji Figure 7 33 Katakana Conversions From Romaji J015153L EPS ...

Page 358: ...Host Communication Interface Katakana Conversions From Romaji Sample Programming IMMAGE 800 Operations Manual A11403 Page 7 98 September 2016 ...

Page 359: ...s Recall 8 2 Overview 8 2 Recalling Results by Sample ID 8 3 Recalling Results by Rack and Position 8 5 Recalling Results by Patient ID 8 7 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 ...

Page 360: ...erview Introduction This chapter discusses how to recall and print patient and control results Results can be recalled by sample 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 ...

Page 361: ...al Sample ID or a series of Sample IDs the Sample IDs desired for recall in the Sample ID s field up to 42 characters spaces are not allowed A single Sample ID has a maximum of 15 characters Sample IDs can be separated by a comma as a series a range of Sample IDs the Sample ID at the beginning of the range in the Range field Press Enter Type the Sample ID at the end of the range in the Thru field ...

Page 362: ...ll results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database NOTICE Patient results restored from diskettes cannot be sent to the host 5 Select a function button from the bottom of the screen 6 Refer to Displaying Recalled Results on the Screen and Printing a Recalled Result in this cha...

Page 363: ... numbers desired for recall up to 15 characters Numbers can be separated by a comma as a series and or by a dash as a range Note If one rack number and no position number is entered all positions on the rack are automatically selected more than one rack number is entered All positions on each rack are automatically selected The Pos s field cannot be accessed 4 Select the options button beside the ...

Page 364: ...by Rack and Position Results Recall IMMAGE 800 Operations Manual A11403 Page 8 6 September 2016 7 Refer to Displaying Recalled Results on the Screen and Printing Recalled Results in this chapter to display or print results Step Action continued 2 of 2 ...

Page 365: ...ntrol ID up to 15 alphanumeric characters in the Patient ID field 3 Select the options button beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the da...

Page 366: ...wed for middle initial entry In this case samples are retrieved based on exact matches of the last name first name with any or no middle initial 3 Select the options button beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10...

Page 367: ...ranges in the From fields and To fields Refer to Table 8 1 3 Select the options button beside the Data Source field 4 Select Computer to recall results in the current database stored in the hard disk OR Select Diskette to recall results from diskettes that have been restored into the hard disk Refer to CHAPTER 10 Utilities Backup Restore for instructions on how to back up and restore the database ...

Page 368: ...r period of that date The order and the separator character are defined in Setup An entry in the From field is required Time From and To 12 hour format hh 1 12 mm 0 59 AM PM Select the options button beside the AM PM field Select AM or PM A time entry is optional If only a date is entered results will be recalled for each 24 hour period in the date range Time is not allowed to be entered unless da...

Page 369: ...sults Follow the steps below to display results on the screen Figure 8 2 Results Screen Step Action 1 From the Recall Results screen select the results to be viewed 2 Select Display Results F1 Refer to Figure 8 2 3 Select Page Up or Page Down to view other pages of the same sample Each sample generates at least two report pages 4 Select Prev Sample F9 or Next Sample F10 to view other samples if mo...

Page 370: ...mat setup refer to CHAPTER 5 System Setup Report Setup For examples of result report formats refer to APPENDIX B Reports Step Action 1 From the Recall Results screen select the results to be viewed as described previously in this chapter 2 To print using then default report format Go to Step 5 non default report format Continue to Step 3 3 Select Report Format F7 A Patient Report Format dialog box...

Page 371: ...the host computer Additional Information Refer to CHAPTER 5 System Setup Host Communications Setup for information about autosend Step Action 1 From the Recall Results By screen select a single sample or range of samples to send to the host computer 2 To select send results to the host computer without displaying them Send to Host F8 display results and send them to the host computer Display Resul...

Page 372: ...Sending Results to the Host Additional Information Results Recall IMMAGE 800 Operations Manual A11403 Page 8 14 September 2016 ...

Page 373: ...y Control 9 2 Overview 9 2 QC Statistics and Rules 9 3 Defining a Control 9 6 Editing a Control 9 12 Reviewing a Control Definition 9 16 Deleting a Control Definition 9 18 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 ...

Page 374: ...nded 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 More frequent use of controls or the use of additional controls is left to the discretion of ...

Page 375: ...eptable 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 Accuracy and Precision Flags The IMMAGE...

Page 376: ... than 2 SD on opposite sides of the assigned mean the current result receives the Precision flag on the QC Log report signifying a violation of R 4S rule These values appear with a red warning symbol in the QC Log and QC Chart Results Greater Than 4 SD From the Assigned Mean Results greater than 4 SD are included in the QC Log and QC Chart but are not used to calculate statistics Flags Generated o...

Page 377: ...rol Were All on the Same Side of the Mean This rule judges the result out of control if the last ten results from one or two levels were all on the same side of the mean Figure 9 1 QC Accept Reject Chart Using Westgard Rules E015001L EPS ACCEPT REJECT CHART IN CONTROL ACCEPT RUN Control Data 2S 3S 2S 4S 1S X 1 1 2 R 4 10 YES YES YES NO NO NO NO NO NO YES YES YES OUT OF CONTROL REJECT RUN EVALUATE ...

Page 378: ...ration Refer to the IMMAGE Immunochemistry Systems Chemistry Information Manual for specific information QC File Number The QC file number is a number from 1 999 which is unique to a chemistry defined within a control name If the QC file number has already been assigned the database will not accept it a second time The file number can be reused after a chemistry in a control is deleted Assigned Me...

Page 379: ... in the Control Lot field The lot number can contain up to 12 alphanumeric characters No spaces are allowed Press Enter 6 Select the Sample Type from the options button The default sample type is serum 7 Select Add Del Chem F1 to select chemistries for the control Refer to Figure 9 4 Use the Page Up Page Down buttons to view additional chemistries 8 Select the desired chemistries Deselecting a sel...

Page 380: ...Controls screen and save the control definition 14 A message will display upon exiting the screen if there is any missing information for the control definition Refer to Figure 9 4 Select OK to exit without saving the control OR Select Cancel to return to the Define Edit screen to add the necessary information 15 A Define Edit Controls dialog box is displayed when the Assigned Mean field and or As...

Page 381: ...l Entering the Minimum Control Definition IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9 9 9 Figure 9 2 Quality Control Screen Figure 9 3 Define Edit Controls Screen E014029S EPS E014031S EPS ...

Page 382: ...n Each Control Name can be defined with up to eight different Control IDs The same bar coded control can be repeated in different positions during a run if a different Control ID is assigned Control IDs like Sample IDs must be unique for each sample within a run Control IDs unlike Sample IDs can be reused without being cleared after the control sample is run Results from all Control IDs for a chem...

Page 383: ...orting of erroneous results due to controls being run as patient samples or patient samples being run as controls The Control ID dialog box will display Up to eight unique IDs each with a maximum of 15 alphanumeric characters may be entered Press Tab Enter or use the arrow keys after each bar code ID entry to move between fields 3 Select OK to exit the screen and save the Control IDs OR Select Can...

Page 384: ...d Changing the mean and or SD may affect subsequent QC statistical data Changing previously defined mean and or SD to zero will set the mean to zero and the SD to 99999 Subsequent data points will be compared to the new mean and SD Accessing a Control to Edit When the instrument status is Standby follow the steps below to access a previously defined control and to edit an assigned mean SD constitu...

Page 385: ...umulative statistics are saved 3 Delete existing data and start new statistical database change the mean and or SD to the new values The previous results and cumulative statistics are deleted This option is not available if the control is programmed for a run 3 Enter the revised constituent code beside the chemistry it corresponds to in the Constituent Code field 4 alphanumeric characters type lea...

Page 386: ... results If deleting a chemistry with results Select OK to delete the chemistry from the control OR Select Cancel to return to the Define Edit Controls screen without deleting the chemistry Select OK to delete the results cumulative statistics and chemistry OR Select Cancel to delete the results and cumulative statistics but not the chemistry Enter a maximum of 3 alphanumeric characters in the Ope...

Page 387: ...tional Information IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9 15 9 Additional Information Refer to CHAPTER 5 System Setup Report Setup for information on setting up a report format for surveys ...

Page 388: ...ame to be reviewed 2 Select Review Control F1 Refer to Figure 9 5 3 The information about the control is displayed Select to Control ID F2 View the Control IDs defined for the Control name Select OK to return to the Review Controls screen Delete Control F3 Clear the control Select OK to delete the control OR Select Cancel to return to the Review Controls screen Print Control F10 Print a comprehens...

Page 389: ...ewing a Control Definition Reviewing Deleting and Printing a Control Definition IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9 17 9 Figure 9 5 Review Controls Screen E014033S EPS ...

Page 390: ...llow the steps below to delete a control from the Review Controls screen Step Action 1 Select QC from the menu bar 2 From the Quality Control screen select the button beside the Control Name to be deleted 3 Select Delete Control F3 4 Select OK to delete the control OR Select Cancel to return to the Quality Control screen without deleting the control 5 Enter a maximum of 3 alphanumeric characters i...

Page 391: ...ximum of three alphanumeric characters in the Operator ID field Press Enter Step Action continued 2 of 2 Step Action 1 Select QC from the menu bar 2 From the Quality Control screen select the button beside the Control Name to be deleted 3 Select Define Edit F2 4 Select Delete Control F3 5 Select OK to delete the control OR Select Cancel to return to the Quality Control screen without deleting the ...

Page 392: ...efining a Control in this chapter Displaying QC File Lists Follow the steps below to list QC files Step Action 1 Select QC from the menu bar 2 Select a number beside a defined control If a Control Name is not selected the QC File List by Control Name is displayed with all defined controls 3 Select QC File List F4 Refer to Figure 9 6 4 Select to display the QC list by List CtlName F1 Control name L...

Page 393: ...Displaying the QC File List Displaying QC File Lists IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9 21 9 Figure 9 6 QC File List E014034S EPS ...

Page 394: ...Description of Symbols on the QC Log The following table describes the symbols and flags displayed on the QC Log Table 9 1 QC Log Symbols and Flags Symbol Flag QC Result Interpretation Westgard Rule Violation Result and yellow Warning symbol Result is 2 SD and 3 SD from the assigned mean 1 2S Result and red Warning symbol Result is 3 SD from the assigned mean 1 3SD Result red Warning symbol and Ac...

Page 395: ...nd date is the current date Select OK to choose the default Use Tab to toggle between fields Select OK to continue OR Select Cancel to exit 4 The QC Log may be displayed by Chemistry or by Reagent Lot The default display is by chemistry in alphabetical order To display the QC Log by Reagent Lot select Rgt Lot F2 Refer to Figure 9 7 5 Enter the date range in the date range fields Select OK to conti...

Page 396: ...rom the Quality Control screen select the control desired Use the Page Up Page Down buttons to access additional controls 2 Select QC Log F5 3 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select OK to choose the default Use Tab to toggle between fields Select OK to continue OR Select Cancel to exit 4 Select the result by selecting the c...

Page 397: ...h the initials of the operator who deleted it However the data point will no longer be included in any calculations or summaries Step Action continued 2 of 2 Step Action 1 From the Quality Control screen select the control desired Use the Page Up Page Down buttons to access additional controls 2 Select QC Log F5 3 Enter a Start date and an End date in the date range fields The default Start End da...

Page 398: ...QC Log Action Log Quality Control IMMAGE 800 Operations Manual A11403 Page 9 26 September 2016 7 Select Print F10 to print the QC Log Step Action continued 2 of 2 ...

Page 399: ... steps below to access the QC Summary Additional information Refer to CHAPTER 5 System Setup Report Setup Defining Inter Lab Information for information on setting up a Inter Lab reference number and contact person for the Inter Lab QC Summary Step Action 1 From the Quality Control screen select the control desired Use the Page Up Page Down buttons to access additional controls 2 Select QC Summary...

Page 400: ...Displaying QC Summaries Additional information Quality Control IMMAGE 800 Operations Manual A11403 Page 9 28 September 2016 Figure 9 8 QC Summary E014038S EPS ...

Page 401: ...ange if the assigned mean and or SD are modified Step Action 1 From the Quality Control screen select the control desired Use the Page Up Page Down buttons to access additional controls 2 Select QC Chart F7 Refer to Figure 9 9 3 Enter a Start date and an End date in the date range fields The default Start End date is the current date Select OK to choose the default Use Tab to toggle between fields...

Page 402: ...Operations Manual A11403 Page 9 30 September 2016 Figure 9 9 QC Chart 7 Select to Control Chems F1 specify other chemistries for charting QC File F2 specify other File Numbers for charting Print F10 print a copy of the QC Chart s Step Action continued 2 of 2 E014039S EPS ...

Page 403: ...cs 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 Some QC Files must be deleted to make room for new QC Files Upon reaching 35 000 QC results a result associated with a File Number overwrites the oldest ...

Page 404: ...hout archiving the QC NOTICE If Backup is selected the system will format the diskette before doing the backup All existing files will be overwritten When backup is complete a message is displayed asking the operator whether the backed up results should be deleted 6 At the Backup Restore dialog box select OK to continue 7 NOTICE Once the QC data is deleted from the hard disk modifications are no l...

Page 405: ...QC Backup QC Backup IMMAGE 800 Operations Manual A11403 Quality Control September 2016 Page 9 33 9 Figure 9 10 QC Backup Dialog Box E014040S EPS ...

Page 406: ...C Log QC Summary and QC Chart Modifications to the control files that have been backed up are not allowed Reviewing Archived Data Step Action 1 From the Quality Control screen select the options button beside QC Data Source field Refer to Figure 9 11 Select External Media 2 Insert the archived diskette and select OK in the QC View External Media dialog box to continue OR Select Cancel to exit the ...

Page 407: ...int backed up QC file lists Refer to Displaying the QC File List in this chapter QC Log F5 display the backed up QC log Refer to Accessing QC Logs in this chapter QC Summary F6 display and print a summary of the backed up data Refer to Accessing the QC Summary in this chapter QC Chart F7 view a specific backed up control chart Refer to Accessing QC Chart in this chapter Print Control F10 print bac...

Page 408: ...Restoring and Reviewing Backup Data Reviewing Archived Data Quality Control IMMAGE 800 Operations Manual A11403 Page 9 36 September 2016 ...

Page 409: ...o Maintenance Procedures 10 7 Daily Maintenance Procedures 10 8 Monthly Maintenance Procedures 10 12 As Indicated Maintenance 10 14 Troubleshooting 10 21 Errors 10 21 Event Log 10 43 Callable Diagnostics 10 49 Alignment 10 52 Backup Restore 10 63 Fill Internal Wash Bottle 10 66 Calibrate Touch Screen 10 67 Replacing Parts User Servicing 10 69 Overview 10 69 Syringe 10 70 Sample and Reagent Crane M...

Page 410: ... maintenance essential to obtain accurate results meet inspection and accreditation requirements This section explains how to perform daily maintenance perform monthly maintenance perform as indicated maintenance prime system fluids wash cuvettes Troubleshooting This section will be helpful in diagnosing instrument problems initiating appropriate solutions for problems identified This section expl...

Page 411: ... 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: ...Beckman Coulter Inc Additional Tools Supplies The following items should be available in the laboratory Straight slotted screwdrivers Phillips head screwdrivers Allen wrench 9 64 inch Isopropyl alcohol swabs Household bleach solution Cotton tipped applicators Deionized water Paper towels Lint free tissues Surgical blade Table 10 1 Beckman Coulter Tools and Supplies Item Part Number Maintenance Log...

Page 413: ... procedures pertaining to safe handling of biological hazards while performing system maintenance or repair 4 The instrument status must be in Standby before attempting to clean any part of the instrument 5 Keep clear of all mechanical assemblies when booting up the system or when exiting the Diagnostics function CAUTION Sodium Azide preservative in diagnostic reagents may react with lead or coppe...

Page 414: ... 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: ...cle is performed automatically when The system is in Standby and one or more of the cuvettes has not been washed in the preceding 12 hours The system is in Standby and one or more of the cuvettes has not been used in the preceding 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 hou...

Page 416: ... tubings tips and valves Visual Maintenance Visually confirm that the is Wash Solution 1 volume sufficient to perform the laboratory s daily workload Each box will perform approximately 1 000 tests Blue Wash Solution tubing 2 free of sharp bends or obstructions and is attached to blue fitting Refer to Figure 10 1 Orange Wash Solution tubing 3 free of sharp bends or obstructions and is attached to ...

Page 417: ...September 2016 Page 10 9 10 Figure 10 1 Wash Solution and Waste Containers Observe and Check If then fluid spills are present at location 1 2 or 3 Refer to Figure 10 2 cover spills with 10 bleach solution and wipe with an absorbent towel Call Beckman Coulter Clinical Support Figure 10 2 1 of 2 ...

Page 418: ...ddles while priming or during routine operations fluid leaks or bubbles are present remove bubbles from reagent 1 and sample 2 syringes syringe lines 3 tips 4 and shear valves 5 Refer to Figure 10 3 Bubbles may be removed by gently tapping on the tubing or syringe during the prime function Refer to As Indicated Maintenance in this section for syringe replacement Figure 10 3 If then continued 2 of ...

Page 419: ...ollowing steps 2 Carefully wipe probe and mixer the full length exposed with an alcohol swab Figure 10 5 3 Lower probe covers Step Action continued 2 of 2 Step Action 1 Select Utilities from the menu bar 2 Select 1 Prime from the Utilities dialog box OR Type 1 in the Option No field and press Enter 3 Enter number of primes desired 4 Select OK ...

Page 420: ...the IMMAGE 800 System Cleaning Surfaces Wipe all exposed surfaces on the system and table surfaces with a fresh 10 bleach solution Cleaning Filters To clean fan filters perform the following the steps Table 10 3 Monthly Maintenance Clean Perform Exterior surfaces Record the cycle count Fan Filters Step Action 1 Grasp and pull both fan covers 1 from right side of instrument and remove filters 2 Fig...

Page 421: ...e cycle count 2 Remove filter 1 from the left side of the instrument Figure 10 7 3 Wash the filters with deionized water to remove lint or clean the filters with pressurized air if available 4 Use paper towels or lint free tissues to dry the filter 5 Reinsert filters and replace covers Step Action continued 2 of 2 Step Action 1 Select Status from the menu bar 2 Select 3 Instrument Status Monitor f...

Page 422: ...10 4 As Indicated Maintenance Clean Perform Clean or replace printer cartridge Refer to Printer Manual Replace all Cuvettes every 10 000 tests For systems using DIL2 cuvettes may need to be replaced more frequently Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual Appendix F System Reagent Configuration and Part Numbers for chemistries using DIL2 Decontaminate Sample Reagent Car...

Page 423: ...aminating Carousels and Racks IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10 15 10 Step Action 1 To remove the reagent carousel lift the reagent cover 1 Figure 10 8 2 Pull up on the carousel 1 Figure 10 9 1 of 2 ...

Page 424: ...n approximately 0 5 final hypochlorite solution in deionized water 6 Immerse carousels or sample racks into a large container or sink filled with the bleach solution Allow carousels or racks to soak at room temperature for 15 to 20 minutes 7 Remove the carousels or racks and rinse with deionized water or tap water and let stand until dry 8 Observe rack labels for bubbling peeling or fading Remove ...

Page 425: ...h Reference Cuvette number 40 The instrument status must be in Standby in order to proceed with the steps below Step Action 1 Verify that the cuvette washer is raised into the cuvette wash station If the cuvette washer is lowered into a cuvette select Home from the Main screen to raise the cuvette washer 2 Remove the two reaction module cover screws 1 Figure 10 12 3 Slide reaction module cover for...

Page 426: ...riate for biohazardous materials 6 Wipe the wheel with lint free tissue moistened with DI water 7 Replace all cuvettes handling by the top edges only Refer to Figure 10 15 Confirm that all cuvettes are seated in the reaction carousel Figure 10 15 8 Replace the covers 9 Select Utilities from the menu bar 10 Select 7 Wash Cuvettes from the Utilities dialog box OR Enter 7 in the Option No field and p...

Page 427: ...enu bar 2 Select 7 Wash Cuvettes from the Utilities dialog box OR Enter 7 in the Option No field and press Enter 3 Type the first cuvette number 1 to begin the wash in the Starting Range field and press Enter 4 Type the last cuvette number 39 to stop the wash in the Ending Range field 5 Select OK to start washing the cuvettes NOTICE If Stop is selected to discontinue the cuvette wash Homing of the...

Page 428: ...10 Unscrew bottom syringe screw 1 and top syringe screw 2 Refer to Figure 10 16 Figure 10 16 11 Remove syringe for replacement Figure 10 17 12 Insert new syringe 13 Select Main from the menu bar 14 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 15 Run controls to verify system performance ...

Page 429: ...utions appearing first Call Beckman Coulter Clinical Support as a final resolution Table 10 5 Error Messages Location Explanation Remarks column of patient report System is unable to obtain a valid answer Instrument errors on patient report A code to indicate that the system is operating in a user modified mode Green border pop up window on screen INFORMATIONAL MESSAGE only Yellow border pop up wi...

Page 430: ...lution Wells From Status menu check status of dilution segments and replace segments showing zero 0 status E5 RGT Cart N A Insufficient Chemistry Reagent and or Uncalibrated Reagent If reagent volume is low load a new reagent cartridge and Read Reagents from the Rgts Cal screen If reagent is uncalibrated calibrate E6 Back to Back Excessive Calibrator Replicate Spread Repeat calibration E7 Scale Fc...

Page 431: ...UPPORT E16 Chk Optics Optics Error for AGXS excessive scatter CALL BECKMAN COULTER CLINICAL SUPPORT E17 Chk Optics Optics Error for AGXS Bad Data CALL BECKMAN COULTER CLINICAL SUPPORT E18 RGT Temp OR Reagent Temperature Out of Range 1 Verify reagent fans are turning 2 Close reagent cover 3 Check Status Monitor to verify reagent temperature is within range E19 Anlg Gnd OR Analog Ground Out of Range...

Page 432: ...ange E30 Lo Press Low Pressure Out of Range With system running samples 1 Check Status Monitor 2 Verify low pressure is in range E31 Vac Vacuum Out of Range With system running samples 1 Check Status Monitor 2 Verify vacuum is in range E32 RGT A LVL Level Sense Failure Reagent Compartment A 1 Check and remove bubbles from Reagent Compartment A 2 Rerun sample E33 RGT B LVL Level Sense Failure Reage...

Page 433: ...Home system E42 Excess Scat Excessive Scatter CALL BECKMAN COULTER CLINICAL SUPPORT E43 Blank Term Assoc Blank Terminated CALL BECKMAN COULTER CLINICAL SUPPORT E44 S W Error Bad Test Object Address CALL BECKMAN COULTER CLINICAL SUPPORT E45 Uncal RGT Uncalibrated Reagent Recalibrate reagent E46 DilWell Err Dilution Segments not Defined or Cleared 1 Clear dilution segments 2 Rerun sample E47 S W Err...

Page 434: ...No Model CALL BECKMAN COULTER CLINICAL SUPPORT E57 RXN Temp Reaction Temperature Out of Range 1 Verify cover is in place 2 Check Status Monitor for stable temperature E58 ORLO Low Result Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual for appropriate measuring range E59 ORHI High Result Refer to IMMAGE Immunochemistry Systems Chemistry Information Manual for appropriate measur...

Page 435: ... Calibration Type Incorrect Reagent Card or Bad Read 1 Reread reagent card 2 Reread calibration card E71 Cal Reps Too Few Calibrators Need Two or More Replicates for Calculation Only one Replicate Calculation Repeat calibration E72 No Param No Valid Reagent Parameters A G Reagent Card with no Parameters or Bad Read Reread reagent card E73 RGT Handler Reagent Handler Error CALL BECKMAN COULTER CLIN...

Page 436: ...Event Send Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 104 Event Receive Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 105 P Semaphore Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 106 V Semaphore Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 107 Partition Return Buffer Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 108 Partition Get Buffer Error FATAL CALL BECKMAN COULTER CLI...

Page 437: ...tion WARNING No action required 503 Reagent Section is Inoperable WARNING Home system 504 Sample Section is Inoperable WARNING Home system 505 DAS Reload Error WARNING 1 Select Utils 2 Select 10 Reload DAS code 3 Reboot instrument 801 Level Sense Failure at Buffer Bottle WARNING 1 Check and remove bubbles from buffer 2 Observe that reagent probe enters buffer 3 Rerun sample 802 Level Sense Failure...

Page 438: ...evel Sense False Trigger on Reagent A at Position WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 813 Level Sense False Trigger on Reagent B at Position WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 814 Level Sense False Trigger at Diluent Bottle WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 815 Level Sense False Trigger at Dilution Well WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 816 Level Sense ...

Page 439: ... Listen FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1026 XCOM Error during Select FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1027 XCOM Error during Accept FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1030 Console to CAU Communications Failure Alive Task FATAL Check cables between console and instrument CALL BECKMAN COULTER CLINICAL SUPPORT 1201 Invalid Test Image Element FATAL CALL BECKMAN COULTER...

Page 440: ...ub Sequence Time Tick Not in Ascending Order FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1212 DAS Buffer Overflow Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1213 Calculations Buffer Overflow Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1215 Cuvette Selected for Opportunistic Wash is Out of Range FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 1216 Cuvette Selected for Preferred Wash is Out...

Page 441: ...WARNING Verify instrument is in proper mode for functions selected e g Standby 1602 Optics Check Nia Offset Quality High WARNING Will STOP Run CALL BECKMAN COULTER CLINICAL SUPPORT 1603 Optics Check Nia Range Quality High WARNING Will STOP Run CALL BECKMAN COULTER CLINICAL SUPPORT 1604 Optics Check Nia Range High WARNING Will STOP Run CALL BECKMAN COULTER CLINICAL SUPPORT 1605 Optics Check Nia Ran...

Page 442: ...CAL SUPPORT 1614 Cannot Start Run Internal Wash Bottle Fill Procedure has Timed Out LLS1 WARNING Verify that volume in external wash solution container is sufficient CALL BECKMAN COULTER CLINICAL SUPPORT 1615 Cannot Start Run Internal Wash Bottle Fill Procedure has Timed Out LLS2 WARNING Verify that volume in external wash solution container is sufficient CALL BECKMAN COULTER CLINICAL SUPPORT 1616...

Page 443: ...ARNING is displayed again CALL BECKMAN COULTER CLINICAL SUPPORT 10 Wash the cuvettes twice 1625 CAU Optics Post Run Check Failed NIA Channel WARNING Repeat all chemistries run on the NIA Optics 1626 CAU Optics Post Run Check Failed LPIA Channel WARNING Repeat all chemistries run on the LPIA Optics 1627 Cannot Start Run Alignment Checksum WARNING Reboot the instrument 1628 Cannot Start Run UDS File...

Page 444: ...s for all loaded buffers 2004 Buffer Defined but Not Detected WARNING Load buffers for all defined buffer positions 2005 Diluent Detected but Not Defined WARNING Define diluent positions for all loaded diluents 2006 Diluent Defined but Not Detected WARNING Load diluents for all defined diluent positions 2007 Invalid Card Type Received from MPC FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2008 Reage...

Page 445: ...L SUPPORT 2212 Dilution Handler Fatal Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2214 Image Handler Fatal Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2215 Memory Allocation Error for Image Stack FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2216 Scheduler Supervisor Fatal Error FATAL CALL BECKMAN COULTER CLINICAL SUPPORT 2217 No Dilution Wells Available WARNING 1 From Status menu check ...

Page 446: ...r is closed 2 Check Status Monitor for stable reaction temperature in acceptable range 2404 Reagent Compartment Temperature Out of Range Low WARNING 1 Verify reagent fans are working 2 Verify cover is closed 3 Check Status Monitor for stable reagent compartment temperature in acceptable range 2405 Reagent Compartment Temperature Out of Range High WARNING 1 Verify reagent fans are working 2 Verify ...

Page 447: ... 2418 12 Volt Power Supply Out of Range Low WARNING Observe Status Monitor 2419 12 Volt Power Supply Out of Range High WARNING Observe Status Monitor 2420 Negative 12 Volt Power Supply Out of Range Low WARNING Observe Status Monitor 2421 Negative 12 Volt Power Supply Out of Range High WARNING Observe Status Monitor 2422 24 Volt Power Supply D Out of Range Low WARNING Observe Status Monitor 2423 24...

Page 448: ...Range High WARNING Observe Status Monitor 2432 High Pressure Out of Range Low WARNING With system running samples 1 Check Status Monitor 2 Verify high pressure is in range 2433 High Pressure Out of Range High WARNING With system running samples 1 Check Status Monitor 2 Verify high pressure is in range 2434 Low Pressure Out of Range Low WARNING With system running samples 1 Check Status Monitor 2 V...

Page 449: ... Cage Temperature Out of Range Low WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 2444 Card Cage Temperature Out of Range High WARNING CALL BECKMAN COULTER CLINICAL SUPPORT 2445 Vacuum Reservoir Full WARNING Will STOP Run CALL BECKMAN COULTER CLINICAL SUPPORT 2446 Internal Wash Bottle float switch is disconnected WARNING Will STOP Run CALL BECKMAN COULTER CLINICAL SUPPORT 2447 New failed Sending St...

Page 450: ...ions Manual A11403 Page 10 42 September 2016 2802 Invalid Reagent Type from Reagent Handler FATAL CALL BECKMAN COULTER CLINICAL SUPPORT Table 10 6 Displayed or Printed Error Messages continued Error Abbreviation Message Explanation Action 21 of 21 ...

Page 451: ...ent Information Definition Number Sequential number identifying the order with number one representing the most recent event Class Number corresponding to the 1 25 event classes listed on the event log main screen e g Input Device Events Date Event searches specified for the appropriate Month Day and Year Time Event searches specified for the appropriate Hours and Minutes Description Identifies pr...

Page 452: ...d press Enter Numbers can be separated by a comma as a series and or by a dash as a range Example 2 3 5 9 17 Step Action continued 2 of 2 E014070S EPS Table 10 8 Event Log Options Option Description Display events F1 For reviewing events on the screen Copy to Disk F2 For saving events to a disk for permanent records Date Time F3 For selecting events for a specified date and time Clear events F4 Fo...

Page 453: ... Maintenance Diagnostics 10 Console 11 Motion 12 Status Monitor 13 Instrument 14 LIS Errors 15 LIS Data Stream Step Action 1 Select 2 Event Log from the Utilities dialog box 2 Select the desired option number s OR Type the option number s in the Option No field and press Enter 3 Select Display Events F1 from the Event Log Screen Refer to Figure 10 19 4 To transfer information to diskette select Co...

Page 454: ...y the events to a disk E010274S EPS Step Action 1 Select Copy to Disk F2 from the Event Log Screen 2 Select a drive option by selecting the options button beside the Drive field OR Type the appropriate drive option and press Enter Refer to Figure 10 20 3 Insert disk into appropriate drive 4 Select OK to transfer information to a diskette OR Select Cancel to return to the Event Log Screen without c...

Page 455: ...and time period Figure 10 21 Date Time Dialog Box E010275S EPS Step Action 1 Select Date Time F3 from the Event Log Screen 2 Type in desired time period Press the Enter key to advance the cursor to each field 3 Select OK to return to the Event Log Screen Select Display Events F1 to view events that occurred during the selected time period Refer to Figure 10 21 OR Select Cancel to exit the Date Tim...

Page 456: ...esired events Printing an Event Log Follow the steps below to print an Event Log Step Action 1 Select Clear Events F4 from the Event Log Screen 2 Verify events to be cleared 3 Select OK to remove specified events OR Select Cancel to exit the Clear Events screen without clearing events Step Action 1 Select a desired event from the Event Log Screen 2 Select Display Events F1 3 Select Print ...

Page 457: ...ures described below Home All and Disable All Follow the steps below to home the system or to disable all instrument motors Step Action 1 Select Utilities from the menu bar 2 Select 3 Diagnostics OR Enter 3 in the Option No field 3 Select 2 Callable Diagnostics from the Diagnostics dialog box Refer to Figure 10 22 OR Enter 2 in the Option No field and press Enter 4 Select 1 Electro Mechanical Moti...

Page 458: ...st or to verify The revolutions per minute of the Sample and Reagent Stir Motors The straightness of the Sample and Reagent Mixer Paddle Follow the steps below to measure motor speed or test paddle straightness E014071S EPS Step Action 1 Select Utilities from the menu bar 2 Select 3 Diagnostics from the Utilities screen OR Enter 3 in the Option No field 3 Select 2 Callable Diagnostics from the Dia...

Page 459: ...ion No field and press Enter 5 Observe the Mixer Paddle for sway or wobble during motor exercise Replace the Mixer Paddle if necessary Refer to Replacing Parts User Servicing Sample and Reagent Crane Mixer Paddle in this chapter 6 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 Rev...

Page 460: ...ctional Areas The alignment procedures described below will adjust the following Straightness of the Sample and Reagent Probe Sample Crane Probe Height Depth Reagent Crane Probe Height Depth Optics Wash Head Automatic Depth Alignment Prerequisite Alignment Steps Prerequisite steps are noted on the IMMAGE 800 alignment screens as Step 1 for each alignment procedure These prerequisites are required ...

Page 461: ...ane Mixer Paddle is straight Refer to Callable Diagnostics Sample Stir Motor and Reagent Stir Motor in this chapter 2 Rotate the Crane Assembly so that the crane assembly is facing towards the front of the instrument 3 Raise the probe guard 1 to expose the probes and verify that the probe is aligned with the Crane Mixer Paddle 2 Refer to Figure 10 23 If the probe is then aligned with the Crane Mix...

Page 462: ...o Home All and Disable All in this chapter 2 If aligning the Sample Probe follow the steps below If aligning the Reagent Probe follow the steps below Remove the sample carousel cover by removing the two hex screws 1 on top of the carousel cover removing the two Phillips screws 2 on the right side just above the fan Refer to Figure 10 24 Open the Reagent Carousel lid Place a piece of tape along the...

Page 463: ...traightness of the Sample or Reagent Probe from side IMMAGE 800 Operations Manual A11403 Utilities September 2016 Page 10 55 10 Figure 10 24 Figure 10 25 Step Action continued 2 of 6 A011431P EPS 1 2 A014074P EPS ...

Page 464: ...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 27 Figure 10 27 4 Rotate the assembly towards the appropriate compartment and raise the probe guard to expose the probes Step Action continued 3 of 6 A014075P EPS 1 2 A014076P EPS ...

Page 465: ... the flex coupling to lower the probe so that the upper large diameter portion of the probe falls just inside the compartment and is centered on the tape 6 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 Figure 10 28 Step Action continued 4 of 6 1 2 A014077P EPS ...

Page 466: ...of the probe is lined up with the piece of tape Refer to Figure 10 29 Figure 10 29 If the tip of the probe is then centered 1 between the tape marks the probe is straight Refer to Figure 10 30 not centered between the tape marks align probe by gently bending it to center of the tape marks Figure 10 30 8 Reinstall the sample carousel cover Step Action continued 5 of 6 1 A014078P EPS 1 A014079P EPS ...

Page 467: ...ties from the menu bar 2 Select 4 Alignment OR Enter 4 in the Option No field and press Enter 3 If then aligning the Sample Probe 1 Select 9 Sample Crane Probe from the Functional Areas dialog box OR Enter 9 in the Area No field and press Enter 2 Select 1 Sample Crane Probe from the Alignment dialog box OR Enter 1 in the Procedure No field and press Enter aligning the Reagent Probe 1 Select 10 Rea...

Page 468: ...the alignment procedure 5 Select Yes from the Alignment dialog box to save the alignment data to a temporary file OR Select No to return to the Alignment Reagent Crane Probe screen without saving the alignment data 6 Select any icon from the menu bar Refer to Figure 10 31 Select Yes from the Alignment dialog box to save the new alignment data to the database F1 Prev Align allows the operator to ov...

Page 469: ... OR Enter 1 in the Procedure No field and press Enter 5 Complete Steps 1 3 as described on the screen selecting Continue after performing each step OR Select Stop to exit Select Close to return to the Alignment screen or select Repeat to restart the alignment procedure 6 Select Yes from the Alignment dialog box to save the alignment data to a temporary file OR Select No to return to the Alignment ...

Page 470: ...tomatic Depth Alignment OR Enter 3 in the Procedure No field and press Enter 5 Complete steps 1 3 as described on the screen selecting Continue after performing each step OR Select Stop to exit Select Close to return to the Alignment screen or select Repeat to restart the alignment procedure 6 Select Yes from the Alignment dialog box to save the alignment data to a temporary file OR Select No to r...

Page 471: ...dby in order to proceed with the steps below to back up or restore data Backup Follow the steps below to back up the database Step Action 1 Select Utilities from the menu bar 2 Select 6 Backup Restore from the Utilities dialog box OR Enter 6 in the Option No field and press Enter Select to Backup to Diskette Copy the database to a diskette When prompted insert a diskette into the floppy disk drive...

Page 472: ...Select To Restore Entire Database from Diskette Copy the entire database into the system from the backup diskette When prompted insert the backup diskette into the floppy disk drive Restore View Patient Results from Diskette Copy the View patient results into the system from the backup diskette View patient results can be displayed and printed they cannot be edited or sent to the host When prompte...

Page 473: ...ion Dialog Box 4 Select OK to restore the database OR Select Cancel to exit and return to the Utilities screen 5 When Restore is complete a confirmation is displayed on the screen Refer to Figure 10 33 Select OK to exit 6 Refer to CHAPTER 8 Results Recall to display and print View patient results Step Action continued 2 of 2 E014082S EPS ...

Page 474: ...cessary to fill the internal wash bottle after replacing the empty Wash Solution Container Filling the Internal Wash Bottle Follow the steps below to fill the internal wash bottle The instrument status must be in Standby Step Action 1 Select Utilities from the menu bar 2 Select 8 Fill Internal Wash Bottle from the Utilities dialog box OR Enter 8 in the Option No field and press Enter 3 Select an i...

Page 475: ...ties dialog box OR Enter 11 in the Option No field and press Enter Refer to Figure 10 34 3 To calibrate and enable the touch screen with one finger or an appropriate object touch the crosshairs in the upper left quadrant of the display area twice Next touch the crosshairs in the lower right quadrant of the display area twice OR To exit without saving the calibration select Cancel or any key on the...

Page 476: ...Calibrate Touch Screen Calibrating the Touch Screen Utilities IMMAGE 800 Operations Manual A11403 Page 10 68 September 2016 Figure 10 34 Utilities Screen with Touch Screen Option E014070S EPS ...

Page 477: ...lacing 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 Replacing Syringes Utilities IMMAGE 800 Operations Manual A11403 Page 10 70 September 2016 Syringe Replacing Syringes Refer to As Indicated Maintenance Replacing Syringes in this chapter ...

Page 479: ...mple or Reagent Crane Mixer Paddle Step Action 1 Rotate the Crane Assembly toward the sample carousel 2 Remove the Crane Mixer Paddle 1 by gently pulling it down and out from the crane assembly Refer to Figure 10 35 Figure 10 35 3 Install the new mixer paddle making sure that it is pushed all the way up and properly seated 4 Verify the straightness of the mixer paddle Refer to Troubleshooting Call...

Page 480: ...in order to proceed with the steps below to replace the Sample Probe or the Reagent Probe Step Action 1 Disable all Electro mechanical motions Refer to Troubleshooting Callable Diagnostics Home All and Disable All in this chapter 2 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...

Page 481: ...station 1 remove the tubing from the top of the probe assembly by unscrewing the black fitting 2 Refer to Figure 10 37 Figure 10 37 4 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 Figure 10 38 Step Action continued 2 of 6 1 A012185P EPS 2 1 A014084P EPS 2 ...

Page 482: ...2016 5 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 Figure 10 39 6 Disconnect the RF cable by pulling the connector 1 straight out from the receptacle Refer to Figure 10 40 Figure 10 40 Step Action continued 3 of 6 1 A014085P EPS 1 A012189P EPS ...

Page 483: ...10 75 10 7 At the crane assembly remove the small set screw 1 located near the top right side of the probe RF radio frequency shield housing 2 a brass cylinder Refer to Figure 10 41 Figure 10 41 8 Pull the probe up and out from the crane assembly Refer to Figure 10 42 Figure 10 42 Step Action continued 4 of 6 2 1 A014086P EPS A012191P EPS ...

Page 484: ...igure 10 43 Install the new probe into the crane assembly Figure 10 43 NOTICE Align the hole of the probe with the access hole 1 in the RF housing Refer to Figure 10 44 Figure 10 44 10 Secure the probe by reinstalling the set screw 11 Connect the tubing from the top of the probe assembly 12 Connect the level sense cable to the receptacle Step Action continued 5 of 6 A012190P EPS 1 A012192P EPS ...

Page 485: ...embly access cover Reinstall the level sense cable receptacle cover 14 Select any icon from the menu bar to exit Diagnostics 15 Prime the system Refer to Troubleshooting Daily Maintenance Procedures Priming in this chapter 16 Verify the straightness of the probe Refer to Troubleshooting Alignment Straightness of the Sample Probe in this chapter Step Action continued 6 of 6 ...

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: ...1 1 11 CHAPTER 11 System Status Instrument Commands Table of Contents System Status Instrument Commands 11 2 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 ...

Page 488: ...eft unchanged Up to four dilution segments can be cleared The cleared segments must be replaced with unused segments on the sample carousel Checking Status and Clearing Segments The instrument status must be in Standby in order to proceed with the steps below to check the status of the dilution segments Step Action 1 Select Status from the menu bar 2 Select 1 Dilution Segments Refer to Figure 11 1...

Page 489: ...in order to proceed with the steps below to replace dilution segments Additional Information Refer to CHAPTER 7 Sample Programming for more information on Dilution Segments status E010293S EPS Step Action 1 Lift the cover of the sample carousel 2 Rotate the sample carousel by pressing the advance button in order to access the desired dilution segment if necessary 3 Lift the segment to be replaced ...

Page 490: ...le on a run can be monitored during the run through Sample Carousel Status The status is indicated by the colored indicator beside the Position Number Sample ID Accessing Sample Carousel Status Follow the steps below to access the sample carousel status Figure 11 2 Sample Carousel Status Screen Step Action 1 Select Status from the menu bar 2 Select 2 Sample Carousel Status Refer to Figure 11 2 E01...

Page 491: ...on White Not Programmed Sample is not programmed or saved Purple Host Query Sample ID queries the host for programming Yellow Waiting to Run The sample carousel was scanned and the sample program is recognized by the system Green Running One or more tests requested for the sample are running Red Incomplete At least one test result for the sample is pending Blue Complete All tests requested for the...

Page 492: ... monitor displays the instrument parameters which are continuously monitored Accessing Instrument Status Monitor Follow the steps below to access the instrument status monitor Figure 11 3 Status Monitor Screen Step Action 1 Select Status from the menu bar 2 Select 3 Instrument Status Monitor Refer to Figure 11 3 3 Verify acceptable status monitor parameters Parameters which are out of range displa...

Page 493: ...rument command Accessing Instrument Commands Follow the steps below to access the instrument command buttons Table 11 3 Instrument Commands Command Function Stop Stops instrument immediately current samples being run will be incomplete and must be rerun All sample programming is saved Home Reagent and sample carousels cuvettes and probes return to their home position Pause Stops instrument after c...

Page 494: ...f the cuvettes after the Stop command is selected Table 11 4 Recommended Maintenance After Stop Command Selected After Stop is selected during a run and before Run is selected the cuvettes immediately 1 hour do not require maintenance less than 24 hours later should be washed Refer to CHAPTER 10 Utilities As Indicated Maintenance Washing Cuvettes more than 24 hours later should be replaced Refer t...

Page 495: ...de 01J means that a slope offset adjustment was applied to the chemistry IGG Chemistry Codes The codes for chemistries are shown in the following table Table A 1 Chemistry Codes Code Chemistry Code Chemistry Code Chemistry 01 IGG 16 PAB 47 THE 02 IGA 17 ALB 48 TOB 03 IGM 19 TRU 49 VPA 04 C3 20 A1M 52 DIG 05 AAT 25 APA 57 DNB 06 KAP 26 APB 58 IGE 07 TRF 27 RF 61 IGALC 08 HPT 29 AT3 62 IGMLC 09 C4 3...

Page 496: ...ual A11403 Page A 2 September 2016 Condition Codes The codes for conditions are shown in the following table Table A 2 Condition Codes Condition Code Slope offset adjustment J Calibration re enabled C Reagent expired R Simulated result S Dilution well reused W ...

Page 497: ...libration Load List Calibration Report Sample Programming Sample Load List Post Run Summary Setup Units Slope and Offset Summary Reference Interval and Critical Range Summary User Defined Reagent Chemistries User Defined Chemistry Definition Report User Defined Calibration Results Report User Defined Calibration Report User Defined Single Point Calibration Result User Defined Single Point Calibrat...

Page 498: ...Introduction Patient Chartable Report Reports IMMAGE 800 Operations Manual A11403 Page B 2 September 2016 Patient Chartable Report Figure B 1 Patient Chartable Report ...

Page 499: ...Introduction Control Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 3 B Control Report Figure B 2 Control Report E014102L EPS ...

Page 500: ...Introduction Laboratory Report Reports IMMAGE 800 Operations Manual A11403 Page B 4 September 2016 Laboratory Report Figure B 3 Laboratory Report ...

Page 501: ...Introduction Laboratory Report with Dilutions IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 5 B Laboratory Report with Dilutions Figure B 4 Laboratory Report with Dilutions ...

Page 502: ...Introduction Calibration Load List Reports IMMAGE 800 Operations Manual A11403 Page B 6 September 2016 Calibration Load List Figure B 5 Calibration Load List ...

Page 503: ...Introduction Calibration Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 7 B Calibration Report Figure B 6 Calibration Report ...

Page 504: ...Introduction Sample Load List Reports IMMAGE 800 Operations Manual A11403 Page B 8 September 2016 Sample Load List Figure B 7 Sample Load List ...

Page 505: ...Introduction Post run Summary IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 9 B Post run Summary Figure B 8 Post run Summary E014103L EPS ...

Page 506: ...Introduction Units Slope and Offset Summary Reports IMMAGE 800 Operations Manual A11403 Page B 10 September 2016 Units Slope and Offset Summary Figure B 9 Units Slope and Offset Summary E011432L EPS ...

Page 507: ... Interval and Critical Range Summary IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 11 B Reference Interval and Critical Range Summary Figure B 10 Reference Interval and Critical Range Summary E014105L EPS ...

Page 508: ...ser Defined Chemistry Definition Report Reports IMMAGE 800 Operations Manual A11403 Page B 12 September 2016 User Defined Chemistry Definition Report Figure B 11 User Defined Chemistry Definition Report E011446L EPS ...

Page 509: ...User Defined Calibration Results Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 13 B User Defined Calibration Results Report Figure B 12 User Defined Calibration Results Report E014065L EPS ...

Page 510: ...Introduction User Defined Calibration Report Reports IMMAGE 800 Operations Manual A11403 Page B 14 September 2016 User Defined Calibration Report Figure B 13 User Defined Calibration Report E014064L EPS ...

Page 511: ...Introduction QC File List by Control Name IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 15 B QC File List by Control Name Figure B 14 QC File List by Control Name E014106L EPS ...

Page 512: ...Introduction QC File List by QC File Number Reports IMMAGE 800 Operations Manual A11403 Page B 16 September 2016 QC File List by QC File Number Figure B 15 QC File List by QC File Number E014107L EPS ...

Page 513: ...Introduction QC File List by Chemistry Name IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 17 B QC File List by Chemistry Name Figure B 16 QC File List by Chemistry Name E014108L EPS ...

Page 514: ...Introduction QC Log Report Reports IMMAGE 800 Operations Manual A11403 Page B 18 September 2016 QC Log Report Figure B 17 QC Log Report E014109L EPS ...

Page 515: ...Introduction QC Log by Reagent Lot IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 19 B QC Log by Reagent Lot Figure B 18 QC Log by Reagent Lot E014110L EPS ...

Page 516: ...Introduction QC Chart Report Reports IMMAGE 800 Operations Manual A11403 Page B 20 September 2016 QC Chart Report Figure B 19 QC Chart Report E014111L EPS ...

Page 517: ...Introduction QC Summary Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 21 B QC Summary Report Figure B 20 QC Summary Report E014112L EPS ...

Page 518: ...Introduction Inter Lab QC Summary Report Reports IMMAGE 800 Operations Manual A11403 Page B 22 September 2016 Inter Lab QC Summary Report Figure B 21 Inter Lab QC Summary Report E014113L EPS ...

Page 519: ...Introduction Event Error Log IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 23 B Event Error Log Figure B 22 Event Error Log ...

Page 520: ...ined Single Point Calibration Results Reports IMMAGE 800 Operations Manual A11403 Page B 24 September 2016 User Defined Single Point Calibration Results Figure B 23 User Defined Single Point Calibration Results E011443L EPS ...

Page 521: ...e Point Calibration Update Report IMMAGE 800 Operations Manual A11403 Reports September 2016 Page B 25 B User Defined Single Point Calibration Update Report Figure B 24 User Defined Single Point Calibration Update Report E011444L EPS ...

Page 522: ...Introduction Plot Robust Means Data Report Reports IMMAGE 800 Operations Manual A11403 Page B 26 September 2016 Plot Robust Means Data Report Figure B 25 Plot Robust Means Data Report E011445L EPS ...

Page 523: ... primary reaction with antigen Excess antibody is detected by the further addition of antigen and measurement of reaction rate Assay A test A single concentration determination Assigned mean The mean value defined for a control ASTM protocol A standardized computer interface specification following the guidelines from the American Society for Testing and Materials Bar code card A Beckman Coulter p...

Page 524: ...puter 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 CAP information Information consisting of an ID number and a designated laboratory contact person based on the College of American...

Page 525: ...es on the IMMAGE 800 reaction carousel in which sample and reactants are mixed and the reaction is measured DAS Data Acquisition Software Data bits Low or high voltage signals transmitted through the serial communication data line Data bits are transmitted after a Start bit and before the Parity bit and Stop bit The user can configure the number of bits to be transmitted between the Start bit and ...

Page 526: ...mall molecule that can stimulate an immune response when conjugated with a larger carrier molecule A drug is an example of a hapten Host query A form of bidirectional interface communication When the instrument reads a bar coded sample ID for which it has no program the host computer is queried for the program associated with that sample The host then sends the queried information to the system Ic...

Page 527: ...her Parity A method of detecting serial data transmission errors Patient demographics Information that is associated with a patient such as name ID age or sex Pause An instrument command which allows results to be generated for all samples in progress and then returns the instrument to Standby status Peltier A temperature control system that heats or cools depending on the ambient temperature Prim...

Page 528: ...otors are turned off Start Stop bits Synchronization method that signals the start and end of data transmission in serial communication The Data bits are preceded by the Start bit and followed by the Stop bit Symbology bar code A set of rules for encoding and decoding information contained in a bar code symbol Examples of symbologies are Code 39 Code 128 Codabar and Interleaved 2 of 5 Target value...

Page 529: ...ations screen 5 30 Calculations summary screen 5 30 Calculations Beckman Coulter defined 5 28 Editing variables 5 33 Excretion rate calculations 5 31 Units 5 29 Calibration curve 3 12 Calibration report 6 34 Calibration request 6 26 Calibration status 6 18 Cal failed 6 18 Cal re enabled 6 18 Calibrated 6 18 Requested 6 18 Uncalibrated 6 18 Calibration time limit 6 34 Calibrator bar code card 6 5 C...

Page 530: ... 5 44 Date time dialog box event log 10 47 Decision table 1 4 Decontaminate 10 14 Define edit control 9 12 9 14 Defining a chemistry for a position Beckman chems 5 4 Chemistry configuration 5 4 Chemistry configuration screen 5 4 Defining CAP information Attention person field 5 27 ID number field 5 27 Defining new panels Panel name field 5 9 Panels 5 9 Panels screen 5 10 Panels summary 5 9 Panels ...

Page 531: ...n 5 45 Date time 5 44 Day format 5 44 Day Month Year 5 44 Leading zero 01 5 44 Month Day Year 5 44 Month format 5 44 No leading zero 1 5 44 Order 5 44 Separator field 5 45 Year format 5 44 Year Month Day 5 44 Formatting the time 12 hour 5 46 24 hour 5 46 Date time 5 46 Hour format 5 46 Leading zero 01 5 46 No leading zero 1 5 46 Separator field 5 46 Time format 5 46 Function button 2 34 Function b...

Page 532: ... 3 Function buttons 1 3 Icon buttons 1 3 Keyboard keys 1 3 Options button 1 3 Text field 1 3 Manual format 1 3 Margin of reading accuracy 2 53 Mean 7 38 9 6 Menu bar 2 28 Message bar 2 28 Microalbumin MA 3 8 Microtubes 2 50 Minimum control definition 9 6 9 7 Minimum information 9 6 Minimum sample program required 7 14 Minimum volumes 2 56 Mixer paddles 10 10 10 50 10 69 Monitor 2 22 Monitor power ...

Page 533: ...5 Reagent cartridges 2 5 6 14 Reagent compartment 2 4 5 76 Reagent compartment cover 2 5 Reagent crane 2 6 Reagent paddle mixer 2 7 Reagent parameters 6 7 Reagent probe 2 7 Reagent status calibration status screen 6 3 Reagent syringe pump 2 7 Recall results screen 8 4 Recalling by patient ID 8 7 Recalling by rack and position 8 5 Recalling by run date time 8 9 Recalling by sample ID 8 3 Recommende...

Page 534: ...ing comment from list Sample comment dialog box 7 22 Sample comment list 7 22 Selecting fields to be displayed in sample programming Demographics setup 5 62 Demographics setup screen 5 62 Selecting message header mode Abbreviated header 5 55 Full header 5 55 Message header mode 5 55 Message header record mode 5 55 Selecting non standard dilutions 7 31 7 32 Selecting number from list 2 35 Selecting...

Page 535: ... 78 Rate mode 5 92 Sample reagent volumes 5 80 UDR calibration 5 95 5 97 UDR definition 5 85 User defined reagent chemistry setup 5 68 Approving a single point UDR calibration 5 108 Defining an AGXS limit 5 79 Editing the time range on a robust means data curve 5 111 Plotting a robust means data curve 5 109 Programming a single point UDR calibration 5 97 Recommended order for UDR AGXS flagging lim...

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