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Beckman Coulter UniCel DxC Synchron 800 Instructions For Use Manual

Beckman Coulter UniCel DxC Synchron 800 Instructions For Use Manual

Synchron clinical systems

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UniCel

EC

REP

Beckman Coulter Ireland, Inc.

Mervue Business Park,

Mervue Galway,

Ireland 353 91 774068

BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA 92835 U.S.A.

®

DxC Synchron

Clinical Systems

Instructions For Use

For In Vitro Diagnostic Use Only

This manual is intended for

UniCel

UniCel

© Copyright 2005 Beckman Coulter, Inc.

®

DxC 600

®

DxC 800

A13914-AB

October 2005

®

®

Table of Contents

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Summary of Contents for Beckman Coulter UniCel DxC Synchron 800

Page 1 This manual is intended for ® UniCel DxC 600 ® UniCel DxC 800 Beckman Coulter Ireland, Inc. Mervue Business Park, Mervue Galway, Ireland 353 91 774068 © Copyright 2005 Beckman Coulter, Inc. BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA 92835 U.S.A.
Page 3: Table Of Contents
Table of Contents CHAPTER 1 General Information..................1-1 General Information..................1-1 Manual Conventions ..................1-2 How to Use this Manual ................1-3 Summary of Hazards ..................1-4 Summary of Precautions ................1-7 Symbols and Labels ..................1-12 CHAPTER 2 System Description ................... 2-1 System Description ..................
Page 4 Sample Comments Setup ................4-25 Special Calculations Definition ..............4-26 Timed Urine and Creatinine Clearance Results........... 4-29 Setup Summary.................... 4-30 Units/Precision Setup................... 4-31 User Defined Chemistries Setup..............4-32 Bar Code Setup .................... 4-33 Maximum Sample Program Age ..............4-34 Reserved Racks/Obstruct Detect ..............4-35 Disable Service Monitor ................
Page 5 Printing QC Ranges ..................6-14 QC File List ....................6-15 QC Summary ....................6-16 QC Chart (Levey-Jennings) ................. 6-17 QC Log ......................6-19 Archive QC ....................6-22 Restore and Review Archived Data............. 6-24 CHAPTER 7 Sample Programming ..................7-1 Overview......................7-1 Prior to Programming ..................
Page 6 Three-Month Maintenance ................ 10-44 Four-Month Maintenance ................10-50 Six-Month Maintenance ................10-55 As-Needed/As-Required Maintenance ............10-68 CTS Wick Replacement Procedure ............10-121 CHAPTER 11 System Status and Commands ................ 11-1 Overview...................... 11-1 System Status ....................11-2 Status Summary ................... 11-2 Status-Cycle Count ..................
Page 7 Result Errors and Codes ................13-18 Error Code – Definitions................13-21 Common Error Messages and Corrective Actions ........13-29 GLOSSARY INDEX UniCel DxC Systems Instructions For Use A13914 Table of Contents October 2005 Page 5 of 6...
Page 8 Table of Contents UniCel DxC Systems Instructions For Use A13914 Page 6 of 6 October 2005...
Page 9: Chapter 1 General Information
General Information Intended Use CHAPTER 1 General Information General Information Intended Use ® ® The UniCel DxC Synchron Clinical Systems are fully automated, computer- controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Page 10: Manual Conventions
Manual Conventions Manual Conventions Manual Conventions Manual Conventions This Manual uses the following printed and visual cues to guide the user in responding to printed directions. Table 1.1 Conventions Used in this Manual Convention Description Icon buttons and Icon buttons and dialog box buttons are written in bold. Dialog box buttons Example: Select the Samples icon.
Page 11: How To Use This Manual
How to Use this Manual Manual Format How to Use this Manual 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. Procedure Tables Procedure tables are the most common type of table in this manual.
Page 12: Summary Of Hazards
Summary of Hazards Introduction Summary of Hazards Introduction This section summarizes the hazards associated with the DxC System. Individual hazards associated with a specific procedure in this manual are included in Warning or Caution boxes within the procedures for that task. Please read this section and the following Summary of Precautions before operating the system.
Page 13 10% bleach solution, or use your laboratory decontamination solution. Then follow your laboratory procedure for disposal of hazardous materials. If the UniCel DxC system needs to be decontaminated, call your Beckman Coulter Service Representative for assistance.
Page 14 If the equipment is used in a manner not specified by Beckman Coulter, Inc., the protection provided by the equipment may be impaired.
Page 15: Summary Of Precautions
Beckman Coulter Microtube™ Precautions • Beckman Coulter Microtubes™ are designed for use on specific Synchron systems. Using the appropriate Microtube is essential for proper system operation. • The sample height in the Microtube is critical for correct sample aspiration on all Synchron systems.
Page 16 Summary of Precautions Biohazard Precautions • The use of non-Beckman Coulter, third party Microtubes, which have not been designed and tested on Synchron Systems may result in system damage and/or short sampling. Biohazard Precautions All biohazard precautions should be observed when doing maintenance, service, or troubleshooting on the system.
Page 17 Summary of Precautions CTS Tracking Loss Precautions CTS Tracking Loss Precautions For systems with 1-Blade Thick CTS, if there is an unusual loss of network communication, then a message tells you that if you move a tube to a different instrument, remove its cap.
Page 18 DI water. When running in the CTS mode, if tubes off-loaded from the UniCel DxC Systems have water or droplets of water on the caps, disable the CTS and call Beckman Coulter Technical Support. Note: Oil on a cap is normal.
Page 19 System Configuration Change Precautions Changes to the System Configuration Data should only be done at the request or at the direction of Beckman Coulter, Inc. Entry of incorrect information will lead to system errors. System Restore Precautions...
Page 20: Symbols And Labels
Symbols and Labels Introduction Symbols and Labels Introduction The following is a list of symbols and labels used on the DxC Systems. You will find them affixed to the appropriate components of the system, as described briefly below. Instrument Power Switch, ON This symbol located on the main power switch indicates that the analyzer power is ON when this portion of the switch is in the down position.
Page 21 Symbols and Labels CPU Power OFF Switch CPU Power OFF Switch This symbol is located on the face of the Computer (CPU) unit and indicates the OFF state when pressed. Primary Electrical Ground This symbol is used to indicate an electrical ground. Keyboard Connection This symbol is found above the connection between the computer and the keyboard.
Page 22 Symbols and Labels Mouse Port Connection Mouse Port Connection This symbol is found next to the connection between the computer and the mouse port. High Voltage Electric Shock Risk This symbol indicates high voltage is present and /or there is a risk of electric shock when working in this area.
Page 23 Symbols and Labels Laser Bar Code Caution Laser Bar Code Caution A label reading, "CAUTION. LASER LIGHT ACCESSIBLE. WHEN COVER IS OPEN OR REMOVED, DO NOT STARE INTO BEAM." is placed on the cover of any laser-based code reader. Do not stare into laser light beam when cover is open or removed.
Page 24 Symbols and Labels ISE Cover Caution ISE Cover Caution A label reading, "THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION." is placed on top of the ISE module frame under the ISE cover to indicate that the ISE cover should remain in place during system operation. THE ISE COVER SHOULD REMAIN IN PLACE DURING SYSTEM OPERATION.
Page 25 21 CFR CHAPTER I, SUBCHAPTER J MANUFACTURED DECEMBER 2004 LABEL P/N 448229 AB BECKMAN COULTER, INC MADE IN U.S.A. MARCA REG A011540L.EPS Ethernet/Serial Port Label This label is found on the right side of the system and identifies connections for the Ethernet and serial ports.
Page 26 It is very important that customers understand and follow all laws regarding the proper decontamination and safe disposal of electrical equipment. For Beckman Coulter products bearing this label please contact your dealer or local Beckman Coulter office for details on the take back program that will facilitate the proper collection, treatment, recovery, recycling and safe disposal of device.
Page 27: Chapter 2 System Description
System Description Introduction CHAPTER 2 System Description System Description Introduction The following chapter briefly describes the system components, operational theories, principles of measurement, programming structure, and operator controls. Detailed information is located in the UniCel DxC Synchron Clinical Systems Reference Manual.
Page 28: Operational Conditions
Operational Conditions Shipping Damage Each DxC System is carefully examined and checked by Beckman Coulter, Inc. before it is shipped. When you receive your new DxC System, visually inspect the shipping container for damage. If there is damage, notify the Beckman Coulter Service Representative before he or she arrives at your facility to install your system.
Page 29 Operational Conditions Power Requirements Power Requirements Table 2.3 Power Requirements Item Requirement Operating range 180–264 V AC, RMS 220 V AC nominal, approximately 15 A at low line, exclusive of power on surge Frequency 47–63 Hz (50/60 Hz nominal) BTU generated DxC 600: 7,200 BTU/hour at nominal (estimated) DxC 800: 7,500 BTU/hour at nominal (estimated) DxC PC: 979 BTU/hour...
Page 30 Operational Conditions Water Requirements Water Requirements Table 2.5 Water Requirements Item Specification Flow Rate 0.6 L/min peak flow rate 16 L/hr, minimum continuous flow rate Temperature +15°C to +25°C Water quality NCCLS Type II deionized water, except for total bacteria count < 10 cfu/mL Water pressure Deionized water entering the system must be 30–90 psig.
Page 31: System Components
System Components DxC Systems System Components DxC Systems A UniCel DxC System can be divided into the following components: • Sample Handling Components • Modular Chemistry System • Cartridge Chemistry Reagent Handling System • Hydropneumatic System • Operation and Control Components A Closed Tube Sampling System has optional components listed below: •...
Page 32 System Components DxC Systems A015901P.EPS Figure 2.2 UniCel DxC 800 Analyzer System Description UniCel DxC Systems Instructions For Use A13914 Page 2-6 October 2005...
Page 33: Sample Handling System
Sample Handling System Introduction Sample Handling System Introduction The Sample Handling system is composed of the following components: • Sample racks • Autoloader/Offload track • Priority load position • Shuttle • Bar code reader • Cap piercer assembly (optional) • Sample Carousel •...
Page 34 16 × 100 mm tubes 16 × 92 mm tubes 16.5 × 100 mm tubes Beckman Coulter 0.5 mL Cup Insert (P/N 476399) (2 of 2) Rack ID Labels Sheets of bar-coded rack ID labels are supplied with the system. They can be applied...
Page 35 Sample Handling System Autoloader/Offload Track Autoloader/Offload Track When viewed from the front of the system, the autoloader is on the left and holds up to 25 sample racks in preparation for presentation to the DxC 800 system. The DxC 600 system has room to load a maximum of 14 racks.
Page 36 Sample Handling System Priority Load Button Priority Load Button Typically, rack placement and removal is under microprocessor control. The operator may choose to use the reserved positions by pressing the PRIORITY LOAD button and placing the priority rack in the space provided by the system. (Refer to Figure 2.4.) The rack will load into one of the reserved positions on the Sample Carousel.
Page 37 Sample Handling System 1-Blade Thick CTS (Closed Tube Sampling) Cap Piercer Assembly (optional) 1-Blade Thick CTS (Closed Tube Sampling) Cap Piercer Assembly (optional) CAUTION This Cap Piercer contains a razor sharp blade assembly. CAUTION Do NOT use this Cap Piercer assembly with foil-capped tubes. This would give level sense errors.
Page 38 Sample Handling System Sample Carousel Sample Carousel The ten-rack position Sample Carousel is a motor-driven turntable. (Refer to Figure 2.5.) Under normal operation, eight of the Sample Carousel positions are available for routine processing and two positions are reserved for priority racks. A015903P.EPS 1.
Page 39: Modular Chemistry (Mc) System
Modular Chemistry (MC) System Introduction Modular Chemistry (MC) System Introduction The Modular Chemistry system consists of the following major assemblies: • Reagent storage area • Ratio pump • Sample probe • Electrolyte injection cup (EIC) • Flow cell assembly • Chemistry reaction modules A detailed description of each component is presented in the following paragraphs.
Page 40 Modular Chemistry (MC) System Reagent Bar Code Reader (Modular) Reagent Bar Code Reader (Modular) Behind the left side door of the system there is a hand-held bar code reader. (Refer to Figure 2.6.) When this reader is held up to the label of one of the modular reagents and the trigger is pressed, the identity of the reagent, the lot number and reagent volume are automatically entered into the reagent load screen.
Page 41 Modular Chemistry (MC) System Electrolyte Injection Cup (EIC) Electrolyte Injection Cup (EIC) The EIC mixes the sample and buffer prior to delivery of the sample (now diluted) to the flow cell. 1. Waste outlet 4. Reference inlet 2. Flow Cell outlet 5.
Page 42 Modular Chemistry (MC) System Flow Cell Assembly Flow Cell Assembly The flow cell assembly houses the seven electrodes that perform the analysis of sodium, potassium, chloride, carbon dioxide, and calcium. (Refer to Figure 2.9.) 1. Inlet port 6. Exit port for waste (large tube) 2.
Page 43 Modular Chemistry (MC) System Chemistry Reaction Modules (Basic Components) Chemistry Reaction Modules (Basic Components) Each of the six Chemistry Reaction Modules have similarities in their design. These common elements are described below. (Refer to Figure 2.10.) Unique design elements of the modules are described under the specific module headings later in this section.
Page 44: Cartridge Chemistry (Cc) Reagent Handling System
Cartridge Chemistry (CC) Reagent Handling System Introduction Cartridge Chemistry (CC) Reagent Handling System Introduction The Cartridge Chemistry Reagent Handling system is composed of the following components: • Reagent cartridges • Reagent carousel • Reagent probe assembly • Reagent mixer assembly •...
Page 45 Cartridge Chemistry (CC) Reagent Handling System Reagent Carousel Reagent Carousel The Reagent Carousel Compartment provides an on-instrument storage area for the individual reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time. (Refer to Figure 2.12.) The storage compartment is refrigerated and fan-cooled to maintain a temperature of...
Page 46 Cartridge Chemistry (CC) Reagent Handling System Reagent Mixer Assembly A015908P.EPS 1. Reagent Mixer 2. CC Reagent Probe A 3. CC Reagent Probe B 4. Collar Wash Figure 2.13 CC Reagent Probe Area Reagent Mixer Assembly This assembly consists of a mechanical structure that supports a single, moveable crane.
Page 47: Cuvette Reaction System
Cuvette Reaction System Introduction Cuvette Reaction System Introduction The Cuvette Reaction system consists of the following components: • Reaction carousel assembly • Photometer assembly • LPIA (Large Particle Immuno Assay) or NIPIA (Near-Infrared Particle Immuno Assay) module (optional) • Cuvette wash station The Cuvette Reaction system involves the process of obtaining absorbance readings from each cuvette during the analysis cycle.
Page 48 Cuvette Reaction System Photometer Assembly A015909P.EPS 1. LPIA module 2. Reaction carousel 3. Photometer Figure 2.14 Reaction Carousel Area (Typical – Cover Removed) Photometer Assembly Attached to the reaction carousel support frame is the Photometer assembly. This consists of a xenon pulse lamp, a discrete 10-position silicon-diode detector array, a monochromator housing unit, and associated electronic circuitry.
Page 49 Cuvette Reaction System Cuvette Wash Station Cuvette Wash Station The Cuvette Wash Station, (refer to Figure 2.15), consists of four coaxial probes, an elevator assembly, and the associated tubing. A motor controls the vertical motion required by the elevator to raise and lower the probes during the wash stage.
Page 50: Hydropneumatic System
Hydropneumatic System Introduction Hydropneumatic System Introduction The main components of the Hydropneumatic System are mounted on a slide-out drawer that allows for easier operator access. (Refer to Figure 2.16 Figure 2.17.) When fully extended, the drawer locks open. To close, lift up on the metal tabs, located on each side of the bottom runner of the hydropneumatic unit, and push the drawer inward.
Page 51 Hydropneumatic System Function A015911P.EPS 1. Waste exit 5. Vacuum accumulator 2. Waste B exit 6. Waste B canister 3. DI water inlet On/Off 7. Waste canister 4. DI water reservoir Figure 2.17 DxC 800 Hydropneumatics (left side) UniCel DxC Systems Instructions For Use A13914 System Description October 2005 Page 2-25...
Page 52: Operation And Control Components
Operation and Control Components Operator Controls Operation and Control Components Operator Controls The operator interfaces with various control devices such as the keyboard, monitor and push-button controls during a routine run. Basic operating functions are controlled and reviewed from the monitor. Calibration functions are also controlled from the monitor. Information is selected and entered into the system through touch screen monitors, from a mouse, and/or at a keyboard.
Page 53: Main Operator Screen And Program Structure
Main Operator Screen and Program Structure Main Operator Screen Main Operator Screen and Program Structure Main Operator Screen DxC System operating and programming functions are initiated from the main operator screen at the DxC analyzer (refer to Figure 2.18). In addition, the screen provides status information to help determine the present state of the system.
Page 54 Main Operator Screen and Program Structure Printing Data From a Screen To load an alternate language, select the desired language from the Choose a Language dropdown list and select the <Install Manual> button. You can then view the IFU Manual in the selected language as described in the preceding paragraph. To view the License Agreement, simply select the <License>...
Page 55 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Table 2.10 Main Operator Screen Status Functions , continued Status Indicator Status Description System Status This indicator appears just below the Function Selection Icons on the left side of the Operator screens (refer to item 3 on Figure 2.18).
Page 56 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Main F1 Results F2 Unload F8 Log F9 Pre Run System Replicates F10 Post Run F1 Sample Sample Replicate Serum Index F2 Edit F2 Demog Off-line Dilution Factor Samples F3 Urine Manual ORDAC...
Page 57 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Rgts/Cal F1 Load F1 Clear F2 Params F10 Done F3 No Load Load calibrator diskette F4 Cal Calibrator acceptance limits F5 List Modify set points F6 Options Slope/Offset adjustment Within lot calibration Enzyme Validator Calibration override...
Page 58 Main Operator Screen and Program Structure Function Selection Icons and Program Structure F1 Chems Setup 1. Auto Serum Index/ORDAC F1 Restore F2 UDR F10 Done F3 Define 2. Chem Config/Sample Type F4 Clear F1 Date F5 Insert F2 Time F6 Delete 3.
Page 59 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Setup, 12. Special Calculations F1 View continued F2 Define F3 Delete F10 Done 13. Setup Summary F10 Done 14. Units/Precision F1 Restore F10 Done 15. User-Defined Chemistries F1 Define F1 Restore F2 Delete F9 Cancel...
Page 60 Main Operator Screen and Program Structure Function Selection Icons and Program Structure All CC Subsystems Utils 1. Prime F1 Prime All Hydropneumatic Subsystems All MC Subsystems Prime DxC Prime CTA Prime CTA Auto-Gloss CTS Auto-Gloss CTS Blade Wash Reagent Delivery Subsystem Sample Delivery Subsystem F2 CC Cuvette Wash...
Page 61 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Utils, 3. Event Log Display continued Copy Time Clear Print Done 1. Chemistry Errors 2. Motion Errors 3. Status Monitor Errors 4. Other Instrument Errors 5. Instrument Events 6.
Page 62 Main Operator Screen and Program Structure Function Selection Icons and Program Structure Performance Verification Tests Utils, 6. PVT Sub-Functional Area continued Test Selection - Based on Functional Area Selected F10 Exit 7. Modem System Parameters 8. Backup/Restore Alignment Data Files Backup Restore Cancel...
Page 63: Theory Of Operation
Theory of Operation Introduction Theory of Operation Introduction The UniCel DxC Synchron Clinical Systems are microprocessor-controlled, random access clinical analyzers capable of processing a wide variety of operator-selected chemistries in a single run. Cartridge Chemistries (CC) The optical system of the DxC enables rate, endpoint, and nonlinear analyses to be performed simultaneously.
Page 64: Cartridge Chemistry: Calibration Theory
Cartridge Chemistry: Calibration Theory Introduction Cartridge Chemistry: Calibration Theory Introduction Calibration determines the relationship between measured reaction responses and known concentrations. Calibration factors are derived from this relationship. These factors are used to convert the measured reaction responses to final concentration results.
Page 65 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Endpoint and First-Order Calibration Formulas The calibration factor is determined by using one of the following equation sets where reaction and blank are used from the usable replicates. Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries Type Formula...
Page 66 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries , continued Type Formula Blanked FOR HIGH CALIBRATOR LEVEL: Endpoint (Reaction ABS - Blank ABS) = Delta ABS rep1 Chemistries (Reaction ABS - Blank ABS) = Delta ABS rep2 (Delta ABS...
Page 67 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries , continued Type Formula Blanked FOR HIGH CALIBRATOR LEVEL: Endpoint Chemistries Blank Volume Blank Correction Factor = (with Volume Total Reaction Volume Correction) Volume of Reagent(s) (and Sample) at Blank Read Volume of Total Reagent and Sample at Reaction Read...
Page 68 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries , continued Type Formula Nonblanked FOR HIGH CALIBRATOR LEVEL: Rate Reaction Rate = Rate rep1 Chemistries Reaction Rate = Rate rep2 (Rate + Rate...
Page 69 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries , continued Type Formula Blanked Rate FOR HIGH CALIBRATOR LEVEL: Chemistries (Reaction Rate - Blank Rate) = Delta Rate rep1 (Reaction Rate - Blank Rate) = Delta Rate rep2 (Delta Rate...
Page 70 Cartridge Chemistry: Calibration Theory Endpoint and First-Order Calibration Formulas Table 2.12 Calculation of Calibration Factors for Endpoint and Rate Chemistries , continued Type Formula Blanked Rate FOR HIGH CALIBRATOR LEVEL: Chemistries (with Volume Blank Volume Blank Correction Factor = Correction) Total Reaction Volume Volume of Reagent(s) (and Sample) at Blank Read Volume of Total Reagent and Sample at Reaction Read...
Page 71 Cartridge Chemistry: Calibration Theory Non-Linear Chemistries Non-Linear Chemistries Non-linear chemistries include drugs and specific protein assays. Unlike the first-order rate and endpoint chemistries, which exhibit a linear response to increasing concentration, the calibration curves for non-linear chemistries exhibit logarithmic (S-shaped) or other nonlinear relationships. For this reason, curve fitting interpolation techniques are employed to construct the calibration curve.
Page 72 Cartridge Chemistry: Calibration Theory Non-Linear Calibration Formulas Table 2.13 Math Models for Non-Linear Chemistries Type Formula Model #1 Math Model #1 is the four-parameter log-logit function most commonly used with reagents that use antibodies. R = R –a–b∗1n(conc) 1 + e E014420L.EPS Sample values are determined using the calculated curve parameters and the math model.
Page 73 Cartridge Chemistry: Calibration Theory Drugs of Abuse Testing (DAT) Chemistries Table 2.13 Math Models for Non-Linear Chemistries , continued Type Formula Model #9 Math Model #9 is an extension to model #1, the four-parameter log- logit function. R = R 1 + c ∗...
Page 74 Cartridge Chemistry: Calibration Theory Enzyme Verification Enzyme Verification Enzyme verification is a means of adjusting enzyme chemistry reporting units to IFCC methods. This feature is available for ALP, ALT-, AST-, CHE, CK-, GGT and LD. Verification also allows results to be adjusted for country specific correlation needs. Verification is similar to calibration except that normalization factors are applied to the sample result in the form of a slope and offset adjustment, whereas calibration factors would be applied to the reaction response.
Page 75: Modular Chemistry: Calibration Theory
Modular Chemistry: Calibration Theory Calibration Theory Modular Chemistry: Calibration Theory Calibration Theory Modular chemistries are calibrated using two to three levels of calibrator (chemistry dependent). Four replicates per level are assayed. Data from two middle replicates of each level is used to set the system response. The highest and lowest replicates are discarded.
Page 76: Cartridge Chemistry: Principles Of Measurement
Cartridge Chemistry: Principles of Measurement Spectrophotometric Methods Cartridge Chemistry: Principles of Measurement Spectrophotometric Methods Spectrophotometric methods rely on the principle that a sample, such as a patient sample, a control, or a calibrator, when mixed with one or more appropriate chemical reagents, produces a substance that has the ability to absorb light at specific wavelengths.
Page 77: Chapter 3 Preparing Samples For Analysis
Routine Operation Overview Daily Procedure CHAPTER 3 Preparing Samples for Analysis Routine Operation Overview Daily Procedure The following table shows an example of daily work flow using the DxC Synchron Clinical Chemistry System. NOTICE This procedure assumes that the initial system setup has been completed. Step Action If necessary, start the system.
Page 78: Sample Programming And Processing
Sample Programming and Processing Introduction Sample Programming and Processing Introduction Sample programming provides the ability to identify samples, select tests to run, describe samples, and designate how to run samples. Samples are programmed through a host computer or Laboratory Information System (LIS or at the analyzer). The minimum information required to save a sample program includes: •...
Page 79 16 × 100 16 × 100 mm tubes 16.5 × 92 mm tubes Beckman Coulter 0.5 mL Cup Insert (P/N 476399) NOTICE Adapters are provided to adapt various sized sample tubes (secondary tubes) to the short racks. These adaptors must only be used in racks designated as reserved.
Page 80 • Remove the cap. • Determine sufficient volume. • Check for fibrin or other materials resulting from storage. Beckman Coulter • Pipette the sample into a Synchron Microtube™. Synchron • Verify there are no bubbles at the bottom of the tube.
Page 81 DI water. When running in the CTS mode, if tubes off-loaded from the UniCel DxC Systems have water or droplets of water on the caps, disable the CTS and call Beckman Coulter Technical Support. Note: Oil on a cap is normal.
Page 82 Sample Programming and Processing Reserved Racks The 16 × 100 tubes must be run in a non-reserved 16 × 100 mm rack. NOTICE If a sample ID is manually cleared, the CTS tracking information is cleared on that instrument only. If a sample ID is reused and the tube requires piercing, the sample ID must be cleared on the instrument that is loaded first.
Page 83 Sample Programming and Processing Reserved Racks for HbA1c, or IBCT Reserved Racks for HbA1c, or IBCT There are two separate fields for specific tests. One for HbA1c and one for IBCT. If a rack number is entered into one of these fields, any samples run in that rack will only function for that specific test.
Page 84: How To Use Reserved Racks
Recommended Use of Reserved Racks Green Racks Series 350–400 to run: • nesting cups • capillary collection containers • Beckman Coulter Microtubes™ Gray Racks Series 601 to run: • "Barcoded" Calibrators and Controls Purple Racks • Series 401–420 to run HbA1c •...
Page 85 How to Use Reserved Racks Recommended Use of Reserved Racks Assigning or Reassigning Reserved Racks Step Action Select the Setup icon from the menu bar. Select the <Page Down> button on the right side of the screen. Select <17> Reserved Racks/Obstruction Detection. Type 17 in the Option Number field and press [Enter].
Page 86 How to Use Reserved Racks Bar Code Labeling Bar Code Labeling The use of bar code labels is a highly accurate and efficient method for identifying and processing laboratory samples. However, the system must be able to identify and read every bar code label to process each sample correctly.
Page 87 How to Use Reserved Racks Processing Bar Coded Samples Processing Bar Coded Samples Generally, previous sample programming will not need to be cleared before placing a bar coded sample on the instrument. If the lab reuses Sample IDs, previous programming must be cleared. Step Action Load tubes in a rack with the bar code labels visible through the slot on the...
Page 88 How to Use Reserved Racks Processing Unreadable Bar Coded Samples Processing Unreadable Bar Coded Samples If a sample bar code is unreadable and the LIS needs to be queried, use manual assignment. A manual assignment is rack and position and a Sample ID with no other information.
Page 89 How to Use Reserved Racks Processing Samples Manually Step Action , continued Identify samples using the table below: If… Then… Sample has a readable bar • Type in the sample ID. code, • If previous programming appears, it may be necessary to clear it. •...
Page 90 How to Use Reserved Racks Adding Tests or Rerunning a Sample Adding Tests or Rerunning a Sample Step Action Select the Samples icon from the menu bar. Select Rerun [F6]. Type the sample ID, rack, or rack and position for rerun. One or more samples can be programmed to rerun.
Page 91 How to Use Reserved Racks Range of Sample IDs When to Clear Samples Samples should be cleared as follows: If... Then... Sample programming has been completed. Clear sample programming. A sample ID has to be reused. Clear that sample ID first. A sample rack can not be programmed due to Clear that programming.
Page 92 How to Use Reserved Racks Procedure for Clearing Samples Procedure for Clearing Samples Step Action Select the Samples icon from the menu bar. Select Clear [F7]. Sample may be cleared by Sample ID(s), Rack/Position, or by Date/Time created. Type in the specific criteria for deletion. NOTICE Clearing Rack/Position does not clear programming for sample(s) programmed in those positions with associated Sample IDs.
Page 93: Chapter 4 System Setup Options
Overview Introduction CHAPTER 4 System Setup Options Overview Introduction This chapter summarizes the 29 System Setup options depicted on the Setup screens shown in Figure 4.1 Figure 4.2 below: E015930S.EPS Figure 4.1 Setup Screen (scrolled to the top) E015931S.EPS Figure 4.2 Setup Screen (scrolled to the bottom) UniCel DxC Systems Instructions For Use A13914 System Setup Options...
Page 94 Overview Introduction For detailed step-by-step instructions on using the System Setup option, refer to the UniCel DxC Synchron Clinical Systems Reference Manual. System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-2 October 2005...
Page 95: Password Setup
Password Setup Introduction Password Setup Introduction The Password Setup option allows the operator to: • Assign up to 100 user names and their passwords • Assign Administrator or Operator level privileges to each user name • Define/edit or delete user name/password setup •...
Page 96 Password Setup Defining/Editing Password Setup Step Action , continued The Password Setup dialog box shows Page 1 (of 10) of the users with password security. If necessary, select <Page Down> on the right side of the screen to show the user desired. Select New [F1] to enter the password setup for a new user.
Page 97: Auto Serum Index/Ordac
NOTICE The analytical ranges for each analyte are system limits found in the respective CISs. These are the ranges that Beckman Coulter has verified can be achieved by the system. There is no flagging associated with values exceeding these limits.
Page 98 Auto Serum Index/ORDAC Auto Serum Index Auto Serum Index The Auto Serum Index function, when enabled, automatically analyzes every sample for the detection of hemolysis, icerus and lipemia and numeric values (index) for the relative concentrations (range) are included in the report. The values are printed below the Special Calculations area of a patient report.
Page 99: Configuring The Chemistry Menu
Configuring a Beckman Coulter Chemistry The chemistry menu, available in sample programming, quality control, panel definition and other screens, is defined by the user. To define Beckman Coulter chemistries, select <2> Chemistry Configuration/Sample Type from the Setup screen. Place the cursor in an open field in the Configuration Chemistry screen and press Chems [F1].
Page 100 The Delete Chemistry function requires that you first clear the calibration, sample programming and control (QC) information from the instrument before deleting the chemistry from the system. Where it is used, Beckman Coulter recommends that you remove chemistries from the system following the sequence and procedures below to...
Page 101 Configuring the Chemistry Menu Deleting a Chemistry Step Action , continued Remove the reagent cartridge.To remove the reagent cartridge DIG: • Select the position for the chemistry to be removed. • Select Load [F1]. • If prompted by the instrument to remove the reagent cartridge, open the reagent carousel door to remove the cartridge.
Page 102 Configuring the Chemistry Menu Deleting a Chemistry 3. Remove the chemistry from the Quality Control (QC) program. A. If a control is defined solely for that chemistry and is no longer needed, the entire control definition should be deleted. Step Action Select the QC icon from the menu bar.
Page 103 Configuring the Chemistry Menu Beckman Coulter Defined Chemistries with Units and Precision 4. Deleting a chemistry from the system (Example: DIG) Step Action Select the Setup icon from the menu bar. Select <2> Chemistry Configuration/Sample Type. Type 2 in the Option Number field and press [Enter].
Page 104 Configuring the Chemistry Menu Beckman Coulter Defined Chemistries with Units and Precision Table 4.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units and Precision , continued Beckman Coulter Defined Chemistry Acronym Units Precision Benzodiazepine BNZG mA/min X.XX Calcium...
Page 105 Configuring the Chemistry Menu Beckman Coulter Defined Chemistries with Units and Precision Table 4.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units and Precision , continued Beckman Coulter Defined Chemistry Acronym Units Precision Hemoglobin A1c HbA1c2 X.XX Immunoglobulin A...
Page 106 Configuring the Chemistry Menu Beckman Coulter Defined Chemistries with Units and Precision Table 4.1 UniCel DxC 600/800 Beckman Coulter Defined Chemistries with Acronyms Units and Precision , continued Beckman Coulter Defined Chemistry Acronym Units Precision Tobramycin µg/dL Total Bilirubin TBIL...
Page 107: Setting The Default Sample Type
Setting the Default Sample Type Introduction Setting the Default Sample Type Introduction Default Sample Type allows for definition of the default sample type for all programmed samples. The sample type may be changed for individual samples while in the sample programming function. Setup To set the default sample type, select <2>...
Page 108: Date/Time Setup
Date/Time Setup Introduction Date/Time Setup Introduction The Date/Time option allows the user to set the date and time, choose the date/time formats that appear on all screens and reports, and restore date and time defaults. The first time the instrument is powered up, the user must set the date and time. Once set, changes to accommodate situations such as converting to daylight-savings time are performed through this option.
Page 109: Demographics Setup
Demographics Setup Introduction Demographics Setup Introduction The Demographics Setup option provides the ability to select the demographics fields that appear in the demographics display/printout of the Program Samples function. Setup From the Setup screen, select <4> Demographics Setup to enable, disable and restore defaults to demographic fields.
Page 110: Patient Results - Immediate Reporting Setup
Patient Results – Immediate Reporting Setup Introduction Patient Results – Immediate Reporting Setup Introduction Immediate Reporting Setup provides the option to print and/or send-to-host results as they are completed on the system. When the STAT reporting option is selected, any MC chemistry programmed as a STAT will immediately print and/or be sent to the host as soon as it is completed.
Page 111: Panels
Panels Introduction Panels Introduction The Panels option allows grouping of analyses commonly programmed and run together. Defining, Editing and Deleting Panels The operator may define a maximum of 50 panels, and must assign a unique name to each. From the Setup screen, select <6> Panels to show the Panel Summary screen, then select [F1] to define, edit or [F2] to delete panels.
Page 112: Replicates
Replicates Introduction Replicates Introduction The Replicates option allows the operator to set up the number of replicates per sample, which is applied to all sample programs. The replicates per sample may also be edited by accessing a specific sample program. A maximum of 20 replicates may be assayed from a sample.
Page 113: Report Setup
Report Setup Introduction Report Setup Introduction This feature allows the operator to select the following options: • Enable or disable printing of Patient and Control Reports • Define a Report Header to print at the top of each report • Select from a variety of Patient Report formats •...
Page 114: Reportable Ranges Setup
• Instrument Printable Range • Reportable Range Analytical Range The Analytical Range is an internal system limit verified by Beckman Coulter. A result exceeding the Analytical Range is flagged OIR HI or OIR LO (Out of Instrument Range). Refer to the Synchron Clinical Systems Chemistry Information Manual for Analytical Ranges by analyte.
Page 115 Reportable Ranges Setup Suppress Results Option The default for a Reportable Range is the Printable Range. The default for Suppress Results is OFF (box is not checked). The system must be in Standby or Stopped to edit these ranges. From the Setup screen, select <9> Reportable Ranges to define, edit, or suppress a reportable result.
Page 116: Reference/Critical Ranges Setup
Reference/Critical Ranges Setup Reference Range and Critical Ranges Reference/Critical Ranges Setup Reference Range and Critical Ranges Reference and Critical Range Setup options allow the operator to define the normal and critical ranges for each analyte by age group, gender and sample type. Up to 32 age ranges may be defined.
Page 117: Sample Comments Setup
Sample Comments Setup Introduction Sample Comments Setup Introduction The Sample Comments option allows the operator to define a maximum of 20 comments for use in the Sample Programming screen. Setup From the Setup screen, select <11> Sample Comments to define, edit or delete sample comments.
Page 118: Special Calculations Definition
The system must be in Standby or Stopped to define, edit or delete operator-defined Special Calculations or to enable/disable them. The default for any Special Calculation is disabled. Beckman Coulter Predefined Special Calculations Defaults Table 4.2 Beckman Coulter Predefined Special Calculations Defaults...
Page 119 Special Calculations Definition Beckman Coulter Predefined Special Calculation Formulas Table 4.2 Beckman Coulter Predefined Special Calculations Defaults , continued Calculation Unit Precision Sample Type Crea Clearance (1) mL/min T Urine Crea Clearance (2) mL/sec T Urine ApoA/ApoB Ratio None Serum...
Page 120 Special Calculations Definition Beckman Coulter Predefined Special Calculation Formulas Table 4.4 UniCel DxC 800 Predefined Special Calculation Formulas Calculation Formula Osmality (1) (1.86 × NA) + (GLUCm/18) + (BUNm/2.8) + 9 Osmality (2) (1.86 × NA) + (GLUCm/18) + (UREAm) + 9...
Page 121: Timed Urine And Creatinine Clearance Results
Timed Urine and Creatinine Clearance Results Introduction Timed Urine and Creatinine Clearance Results Introduction When Timed Urine is designated as the sample type for a Sample ID, the Results report will reflect: • the concentration of the sample aliquot placed on the instrument. •...
Page 122: Setup Summary
Setup Summary Introduction Setup Summary Introduction The Setup summary provides a condensed reference to: • the software version number. • the chemistry database version. The Setup Summary may be viewed at any time. Setup From the Setup screen, select <13> Setup Summary, to review the Setup Summary. System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-30...
Page 123: Units/Precision Setup
Units/Precision Setup Introduction Units/Precision Setup Introduction The Units/Precision option allows the operator to select the units and number of decimal places for each viewed and printed result. When the units are altered, all features affected by the change, such as reference ranges and calibration values, will automatically convert to match the new units.
Page 124: User Defined Chemistries Setup
User Defined Chemistries Setup Introduction User Defined Chemistries Setup Introduction With User Defined Chemistries, a maximum of 100 chemistries may be defined on the UniCel DxC. Setup From the Setup screen, select <15> User-Defined Chemistries. For detailed information about User Defined chemistries, refer to CHAPTER 9, User Defined Reagents in this manual.
Page 125: Bar Code Setup
Bar Code Setup Introduction Bar Code Setup Introduction The Bar Code Setup option allows the operator to: • Enable/disable sample bar code mode of operation • Enable/disable sample bar code types • Configure sample bar code parameters • Restore defaults The four sample bar code types that may be used on the DxC are: •...
Page 126: Maximum Sample Program Age
Maximum Sample Program Age Introduction Maximum Sample Program Age Introduction This feature refers to the age of the sample program. The operator may define the time limit allowed before the same sample ID can be reloaded on the system. The operator is notified of the time conflict by a pop-up window when the time limit has been exceeded.
Page 127: Reserved Racks/Obstruct Detect
Reserved Racks/Obstruct Detect Introduction Reserved Racks/Obstruct Detect Introduction The Reserved Rack/Obstruction Detection option allows the operator to: • Enable/disable the CTS (Cap Piercer) option. • Enable/disable obstruction detection • Assign reserved rack numbers for small sample volume containers • Reserve a rack number or numbers for the analysis of HbA1c or IBCT samples. •...
Page 128: Disable Service Monitor
Disable Service Monitor Introduction Disable Service Monitor Introduction The Disable Service Monitor option permits the service monitor to be disabled. When the Metering Counter is activated, the Service Monitor must be disabled. Refer to the Synchron Clinical Systems Metered-Use Manual for information regarding the metering option.
Page 129: Host Communications
Host Communications Introduction Host Communications Introduction Table 4.5 following lists the Host communications parameters, the options of each, and the default values. Table 4.5 Host Communications Parameter Table Parameter Options Default Device ID 0–99 Flow Control Software (XON/XOFF) Software (XON/XOFF) Hardware (RTS/CTS) No Flow Data Transmission Mode Transmission OFF,...
Page 130: Language/Keyboard Setup
Language/Keyboard Setup Introduction Language/Keyboard Setup Introduction The Language/Keyboard Setup option allows the operator to select from the following languages and keyboards for instrument operation: • English • French • German • Italian • Spanish • Japanese Setup From the Setup screen, scroll down and select <21> Language/Keyboard to select and activate the desired language or keyboard.
Page 131: Printer Setup
Printer Setup Introduction Printer Setup Introduction The Printer Setup option allows selection of paper size. Setup From the Setup screen, scroll down and select <22> Printer Setup to choose one of three paper sizes. The system must be in Standby to make modifications. The default paper size is U.
Page 132: Service Setup
After exiting from Service Setup the screen returns to normal. Enabling Service Setup This feature is password protected and can only be accessed by Beckman Coulter personnel. Disabling Service Setup The Service Monitor mode can be disabled at any time. Refer to...
Page 133: System Configuration
Beckman Coulter. The instrument serial number is also shown in this area. View/Edit System Configuration This feature is password protected and can only be accessed by Beckman Coulter personnel. CAUTION Changes to the information in this area should only be done at the request or at the direction of Beckman Coulter, Inc.
Page 134: Version Upgrade
Version Upgrade Introduction Version Upgrade Introduction The Version Upgrade option allows the operator to load a new version of operating software onto the system. Setup From the Setup screen, scroll down and select <25> Version Upgrade to load an upgrade to operating software. The system must be in Standby or Stopped state to load new software.
Page 135: Status Alarm/Annunciator
Status Alarm/Annunciator Introduction Status Alarm/Annunciator Introduction The Status Alarm/Annunciator option allows the operator to: • Select from 5 different audible alarm patterns • Test the audible alarm • Disable the audible alarm Setup From the Setup screen, scroll down and select <26> Status Alarm/Annunciator to select an alarm pattern, test or disable the alarm.
Page 136: Chemistry Update
Chemistry Update Introduction Chemistry Update Introduction The Chemistry Update option allows the operator to load a new version of chemistry database software that: • Updates chemistries on the existing menu • Adds new chemistries Setup From the Setup screen, scroll down and select <27> Chem Update to load a new version of chemistry database software.
Page 137: Auto Generation Of Control
Auto Generation of Control Introduction Auto Generation of Control Introduction When this feature is enabled, if a sample is loaded with a defined control ID, the instrument will automatically run any chemistry that is on-board and runnable for that control. When Auto Generation of Control is enabled, the automatic Multiple Cartridge option is available.
Page 138 Auto Generation of Control Setup System Setup Options UniCel DxC Systems Instructions For Use A13914 Page 4-46 October 2005...
Page 139: Chapter 5 Reagent Load/Calibration
Reagent Load Introduction CHAPTER 5 Reagent Load/Calibration Reagent Load Introduction This chapter describes how to load reagents onto the DxC 800 and DxC 600 systems and calibrate chemistries using the Reagent Load/Calibration Screen. The DxC system loads and removes both cartridge (CC) and modular (MC) chemistries bulk reagents. Reagent information encoded on the container label can be read by the bar code reader or entered manually from the keyboard.
Page 140 Reagent Load Rgts/Cal Screen Overview Rgts/Cal Screen Overview If the Rgts/Cal icon is red or yellow, select it and look for chemistries that are highlighted red or yellow. (Refer to Figure 5.1.) Red highlighted chemistries will not run. Yellow highlighted chemistries will run, but check the reagent volume before starting.
Page 141 Reagent Load Sorting Reagent Status Table 5.1 Reagent Status Messages , continued Message Explanation Level Sense Error Level sense check failed to properly detect reagent in one or more compartments. Reagent status is not applicable for a chemistry (e.g., an electrolyte chemistry).
Page 142 Reagent Load Load/Unload Reagent A015919P.EPS 1. Reagent Name 2. Serial Number 3. Lot Number 4. Expiration Date Figure 5.2 MC Reagent Information Reagent information is encoded on the label and read by the bar code reader when the reagent is loaded or unloaded from the system. This information makes each container unique and allows the DxC to maintain an accurate inventory of MC reagents.
Page 143 Reagent Load Load/Unload Reagent A015920P.EPS 1. BUNm/UREAm 6. CREm 2. PHOSm 7. Electrolyte Buffer 3. GLUCm 8. Electrolyte Reference 4. TPm 9. CO Acid 5. ALBm Figure 5.3 DxC 800 Leftmost Compartment A015921P.EPS 1. GLUCm 2. CO Acid 3. Electrolyte Buffer 4.
Page 144 Reagent Load Load/Unload Reagent A015922P.EPS 1. Wash Concentrate II 2. No Foam solution 3. CTS Auto-Gloss Figure 5.5 DxC 600/800 Center Compartment Modular chemistry reagent bottles are selected from the Rgts/Cal screen and replaced as necessary according to volume. Reagent volume levels are automatically tracked by the system after the initial volume is set.
Page 145 Reagent Load Load/Unload Reagent Step Action , continued Remove the reagent from the system. It is not necessary to scan the bar code of the reagent bottle when removing it. Note: The No Foam container (located in Figure 5.5, item 2) is refilled by pouring a fresh bottle of No Foam solution into the empty container on the instrument.
Page 146 Reagent Load Load/Unload Reagent Step Action , continued Use the hand-held bar code reader to scan the reagent bar code of each new bottle. The system will "beep" to indicate a successful bar code read. Check the monitor to verify that the reagent data is shown. Once scanned, the reagent screen is updated with current reagent information.
Page 147 Reagent Load Load/Unload Reagent A016485P.EPS 1. Reagent Name 2. Lot Number 3. Expiration Date 4. Serial Number Figure 5.7 CC Reagent Information Load/Unload Cartridge Chemistries (CC) Step Action Select the Rgts/Cal icon from the menu bar. Select all positions to be loaded or unloaded. Selected positions will be highlighted.
Page 148 Reagent Load Load/Unload Reagent Step Action , continued To unload reagent: When the screen prompts you to remove the cartridge (1), open the reagent carousel door. The cartridge to unload will be positioned on either the upper or lower reagent carousel. A blinking bar code reader indicates which carousel position to unload from the upper and lower deck.
Page 149 Reagent Load Reagent Parameters Reagent Parameters Calibration parameters specific for a particular reagent lot are included with certain multipoint, non-linear reagent cartridges. These parameters are referred to as Reagent Lot Specific Parameters. The Reagent Lot Specific Parameters, contained in four bar codes, are included on a card in the Reagent Kit.
Page 150 Reagent Load Reagent Parameters Step Action , continued To manually load reagent parameters: • Type in the parameter information, from the parameter card, on each line of the Load Reagent Parameters dialog box. Note: Readable parameters coincide with each bar code on the card. •...
Page 151: System Calibration
System Calibration Introduction System Calibration System Calibration Introduction System calibration is used to standardize the analysis of samples to existing conditions. Refer to the Synchron Clinical Systems Chemistry Information Manual for detailed information regarding such conditions. In general, system calibration is required when: •...
Page 152: Loading A Calibrator Diskette
Loading a Calibrator Diskette Loading a Calibrator Diskette Serum based calibrators require a calibrator diskette to be loaded on the system. The calibrator diskette is loaded only one time per lot number. • To check what lot number is currently loaded on the system, select the Rgts/Cal icon, then select Options [F6].
Page 153: Calibrator Assignment
Calibrator Assignment Calibrator Assignment To calibrate a reagent, first assign the rack/position or calibrator ID. The assignments can be reused or new assignments can be programmed with each new calibration. Note: A reserved rack must be used when placing a calibrator cup in a tube. Step Action Select the Rgts/Cal icon from the menu bar.
Page 154: Calibration Status
Calibration Status Introduction Calibration Status Introduction Calibration status, as well as reagent status, is accessed from the Rgts/Cal Screen. Calibration status is shown to determine which chemistries require calibration. Calibration Status The following messages are used to indicate calibration status. Table 5.2 Calibration Status Messages Message...
Page 155: Reagent And Calibration Status Warnings
Reagent and Calibration Status Warnings Introduction Reagent and Calibration Status Warnings Introduction When a reagent or chemistry calibration needs attention, a yellow or red warning highlight appears in the applicable place on the Reagent Status/Calibration Status screen. The highlight color depends on the reagent or calibration status. Conditions that Cause a Calibration Status Warning The table below lists the Calibration Status conditions and their related highlights.
Page 156: Requesting A Calibration
Requesting a Calibration Calibrating DxC Chemistries With Bar Code Labels Requesting a Calibration Calibrating DxC Chemistries With Bar Code Labels From the Rgts/Cal screen, check the Calibration Time Left column shown in days:hours:minutes and the Cal Status column to see which chemistries require calibration.
Page 157 Requesting a Calibration Calibrating DxC Chemistries Using Assigned Calibrator Racks Calibrating DxC Chemistries Using Assigned Calibrator Racks From the Rgts/Cal screen, check the Calibration Time Left column shown in days:hours:minutes and the Cal Status column to see which chemistries require calibration.
Page 158: Calibration Failure Messages
Calibration Failure Messages Introduction Calibration Failure Messages Introduction If there is a failure during calibration, for modular chemistry (MC) or cartridge chemistry (CC), there is a pop-up message which shows: • The chemistry that failed and • The associated error code(s). After a failure message, the operator can: •...
Page 159: Within-Lot Calibration
Within-Lot Calibration Introduction Within-Lot Calibration Introduction The Within-Lot Calibration option provides multiple reagent load of cartridges of the same lot number without having to calibrate each cartridge. The calibration factor established from a fresh cartridge (less than 8 hours on board the instrument) will be stored and applied to subsequently loaded cartridges of the same lot.
Page 160 Within-Lot Calibration Within-Lot Calibration Status Screen E015926S.EPS Figure 5.10 Within-Lot Calibration Dialog Box Note: If the within-lot calibration mode is disabled, any existing cartridges that are using the within-lot calibration factor will retain that factor until the cartridge is depleted or until another calibration is requested. When a chemistry is deselected, the following message appears: "If chemistries are deselected, a new calibration factor will need to be generated for all subsequent reagent packs loaded.
Page 161 Within-Lot Calibration Within-Lot Designations E015927S.EPS Figure 5.11 Within-Lot Calibration Status Screen Within-Lot Designations The designations wf, w, and ws follow the reagent lot numbers of those chemistries selected for within-lot calibration. These designations are defined below. Table 5.4 Definitions of Within-Lot Designations Designation Description Reagent has been enabled for within-lot calibration and the...
Page 162 Within-Lot Calibration Within-Lot Calibration Limitations Table 5.4 Definitions of Within-Lot Designations , continued Designation Description Reagent has been enabled for within-lot calibration but is a stand- alone (the calibration factor currently used applies only to this cartridge). A reagent receives this designation if: •...
Page 163: Enzyme Validator
Enzyme Validator Introduction Enzyme Validator Introduction The Enzyme Validator option provides the ability to obtain IFCC/DGKCh (refer to "Additional Information" below) equivalent answers for selective enzymes, or to obtain IFCC/DGKCh equivalent answers for the non-IFCC/non-DGKCh formulation enzymes. • The Synchron Enzyme Validator set is a human serum, albumin-based value assigned material and is used like a calibrator.
Page 164: Calibration Override
Calibration Override Introduction Calibration Override Introduction The Calibration Override option allows the system to override a failed calibration and obtain results based on the failed calibration factors. Calibration Override is available only when an attempt to calibrate the chemistries has been previously made and failed, the status Cal Failed is shown.
Page 165: Chemistry Bypass
Chemistry Bypass Introduction Chemistry Bypass Introduction In the event of a calibration failure for a chemistry which has been previously sample programmed, Chemistry Bypass permits the continuation of analysis of all other programmed tests without having to deprogram a failed chemistry. The chemistry can be bypassed while the system status is Standby, Disabled or Running.
Page 166: Extending Calibration Time
Extending Calibration Time Introduction Extending Calibration Time Introduction The Extending Calibration Time option allows the extension of a calibration that has exceeded the recommended calibration time. The system shows a warning message approximately fifteen minutes prior to the calibration timeout. At this point, the operator can choose to recalibrate the chemistry in question or extend the calibration time.
Page 167: Calibration Acceptance Limits
Calibration Acceptance Limits Introduction Calibration Acceptance Limits Introduction Calibration absorbance or ADC values are compared to preprogrammed back-to-back, span, and range limits to determine acceptable performance. If calibration errors in accuracy, precision, sensitivity, or linearity are detected by the system computer, error flags are generated.
Page 168: Calibrator Set Point Modifications
Calibrator Set Point Modifications Introduction Calibrator Set Point Modifications Introduction The Calibrator Set Point Modifications option allows editing of the programmed calibrator set points. This option can be used to alter any chemistry provided it: • has calibration data. • uses three or less calibrator levels. •...
Page 169 Calibrator Set Point Modifications Modifying Calibrator Set Points Step Action , continued Move the cursor to the set point to be modified and type in the desired value. If a previously modified set point is to be returned to the original default value for that calibrator or chemistry, select desired chemistry, move cursor to the applicable set point and select <Restore Defaults>.
Page 170: Slope Offset Adjustment
Slope Offset Adjustment Introduction Slope Offset Adjustment Introduction The Slope Offset Adjustment option allows adjustment of the slope (m) or the y-intercept offset (b) of the regression equation used for results calculations. Modifications are made on a per chemistry basis. The default value for the slope is equal to "1"...
Page 171 Slope Offset Adjustment Slope Offset Recommendations Step Action Select the Rgts/Cal icon from the menu bar. Select Cal Options [F6]. Select Slope/Offset adjustment using the pull-down menu. Move cursor to the slope and/or offset to be modified. Use <Page Up> or <Page Down> from the screen or the keyboard counterparts to locate the Chem.
Page 172: Reprint Calibration Reports
Reprint Calibration Reports Introduction Reprint Calibration Reports Introduction The five most recent calibration reports for a given calibrator (chem position) may be printed for an historical perspective. Reprinting Calibration Reports The following steps explain how to reprint the current or previous calibration report. Step Action Select the Rgts/Cal icon from the menu bar.
Page 173: Chapter 6 Quality Control
Quality Control Introduction CHAPTER 6 Quality Control Quality Control Introduction This task is performed when your laboratory protocol indicates that control material should be analyzed. A daily analysis of at least two levels of control materials is highly recommended. In addition, these controls should be run with each new calibration, with each new lot of reagents, and after specific maintenance or troubleshooting activities.
Page 174 Quality Control Accuracy and Precision Flags Accuracy and Precision Flags The DxC utilizes the following Westgard rules for evaluation of QC data. • 1-2S: Result Between ± 2SD and ± 3SD From the Assigned Mean If the result is between ± 2 and ± 3 standard deviations from the assigned mean, the result: - is flagged as >...
Page 175 Quality Control Additional QC Precision Rules Additional QC Precision Rules Some additional Westgard QC rules are helpful when determining whether the system is in control. These are not flagged by the DxC QC package but can help in determining system performance. (Refer to Figure 6.1.) •...
Page 176: Defining A Control
Defining a Control Introduction Defining a Control Introduction The operator may define up to 100 controls. The minimum input required to save a control definition is control name, lot number, QC file number, sample type, and one chemistry selection per control. The maximum number of configurable chemistries is 175 per control.
Page 177 Defining a Control Defining a Control Defining a Control Follow the steps below to define or edit a control. NOTICE When defining a control, it is important to select the Sample Type (Step 7) before selecting the chemistries (Step 8). Failure to follow the procedure as described may result in the wrong units being assigned to a chemistry.
Page 178 Defining a Control Defining a Control Step Action , continued Select Chems [F1]. A list of configured chemistries will appear. Add or remove chemistries by selecting and adding to the list, or by selecting and removing from the list. Use the scroll bar to access all chemistries. Select <OK>...
Page 179 Defining a Control Deleting Controls from Definition Screen Step Action , continued Select Done [F10] to leave the definition screen and to save the control. Minimum requirements to save a control definition are control name, lot number and QC file name. If the control definition is not complete, a warning message will appear specifying which information is missing.
Page 180: Control Id Assignments
Control ID Assignments Introduction to Assigning QC Bar Codes Control ID Assignments Introduction to Assigning QC Bar Codes A maximum of eight bar codes (control IDs) per control may be defined. Even if a predefined control ID exists, before running the test, first use the sample programming screen to program the tests for the bar-coded controls.
Page 181: Running Control Samples
Running Control Samples Introduction Running Control Samples Introduction Once the control has been defined, the control sample is run on the instrument with or without bar code labels. Then following procedures describe how to run a control sample for each condition Running Control Samples With Bar Code Labels and Auto Generation of Control Enabled Step Action...
Page 182 Running Control Samples Manually Running Control Samples Manually Running Control Samples Step Action Select the Samples icon from the menu bar. Clear the QC sample ID to be used. • Select Clear [F1]. • Type the QC sample ID into the Sample ID(s) field. •...
Page 183: Editing A Control Definition
Editing a Control Definition Introduction Editing a Control Definition Introduction The assigned mean, SD, constituent code, and bar code IDs of a previously defined control may be edited. The QC File Number associated with any defined control may not be edited. Editing Precautions •...
Page 184: Reviewing A Control Definition
Reviewing a Control Definition Introduction Reviewing a Control Definition Introduction A control definition can be reviewed from either current QC data or archived QC data. Archived QC data may not be modified, only printed. Current QC data may be reviewed, deleted, or printed. Reviewing a QC Follow the steps below to review a control previously defined.
Page 185: Deleting A Control
Deleting a Control Introduction Deleting a Control Introduction Previously defined controls may be deleted and removed from the system. Clearing QC ranges and applicable data can be done for Current QC data only. Controls may also be deleted through define, edit, and review QC functions. Deleting a Control Follow the steps below to delete a previously defined control.
Page 186: Printing Qc Ranges
Printing QC Ranges Introduction Printing QC Ranges Introduction The entire database of controls may be printed. Printing QC Ranges Follow the steps below to print QC ranges. Step Action Select the QC icon from the menu bar. Select the control to be printed or type the item number. From the QC screen, select Print [F10].
Page 187: Qc File List
QC File List Introduction QC File List Introduction QC File List allows the operator to view and/or print a list of QC files by control name, chemistry name or QC file number. The QC File List is accessible from either Current QC data or Archived QC data.
Page 188: Qc Summary
QC Summary Introduction QC Summary Introduction • The QC Summary report contains the mean, SD, CV and number of results (N) for any control run within a specified date interval. The printed report contains the cumulative mean, SD, CV and (N)umber of accumulated results. •...
Page 189: Qc Chart (Levey-Jennings)
QC Chart (Levey-Jennings) Introduction QC Chart (Levey-Jennings) Introduction QC Chart shows the results of a control for a specified period (default is current date) in a graphic form, showing the position of data points relative to the assigned mean and standard deviation. The results are listed by date and time, most recent results first.
Page 190 QC Chart (Levey-Jennings) Accessing QC Charts Step Action , continued The chemistries defined for the selected control are listed. All chemistries appear to be selected. For convenience, there are two ways to select the chemistries to chart: • To chart most of the chemistries shown, select all chemistries which should NOT be charted.
Page 191: Qc Log
QC Log Introduction QC Log Introduction QC Log shows results with information about the relationship of those results to the assigned mean, SD and previous results for a specified data interval. Also shown are data point deletions. The QC Log may be viewed and/or printed from either the hard disk or the floppy disk.
Page 192 QC Log Delete a Data Point Step Action , continued Use the scroll bar to access additional data. Data are shown as follows: • Data points > 2 SD appear in yellow. • Data Points > 3 SD appear in red. •...
Page 193 QC Log Adding a QC Action Log Comment Adding a QC Action Log Comment An action log comment may be added from the QC log screen. Step Action Select a data point by selecting the check box next to the data point. Select Action [F4].
Page 194: Archive Qc
Archive QC Introduction Archive QC Introduction The Archive QC function archives control definition (control name, lot number, sample type, QC File number, QC Log selected chemistries, assigned mean and SD, constituent code, and cumulative mean, SD and N) and results to a floppy disk. Archiving is available from the hard disk only.
Page 195 Archive QC How to Archive QC Step Action , continued Select <OK> or <Cancel>. Note: If the operator answers <OK> to the delete QC data prompt, a warning appears. Press [Enter] to initiate deletion. Select a date interval for QC data deletion by typing a Start date and an End date in the date range fields.
Page 196: Restore And Review Archived Data
Restore and Review Archived Data Introduction Restore and Review Archived Data Introduction Archived data can be reviewed from a floppy disk. Review options available from the floppy include review of demographics and cumulative statistics for a control file, viewing and printing of QC File List, QC Log, QC Summary and Control Ranges. No modifications to the archived control files are allowed.
Page 197 Restore and Review Archived Data Reviewing Archived Data Step Action , continued Select any of the following options: • Review [F1] to review archived control definition. • QC File List [F4] to view and Print archived QC File lists. • Log [F5] to view the Log for the archived data. •...
Page 198 Restore and Review Archived Data Reviewing Archived Data Quality Control UniCel DxC Systems Instructions For Use A13914 Page 6-26 October 2005...
Page 199: Chapter 7 Sample Programming
Overview Introduction CHAPTER 7 Sample Programming Overview Introduction Sample programming provides the ability to identify samples, select tests to run, describe samples, and designate how to run samples. The minimum information required to save a sample program includes: • a Sample ID or •...
Page 200: Prior To Programming
Prior to Programming Prior to Programming Prior to Programming Prior to Programming Prior to programming, it is necessary to verify rack status and sample carousel status. These options will determine which racks are available for programming, for rack assignment, and for determining the instrument status. Rack Status Patient samples, controls, or calibrators may be assigned to racks which are then loaded onto the system for sample processing.
Page 201 Prior to Programming Verifying Sample Carousel Status: Main Operator Screen Table 7.1 Sample Status Designations Sample Status Meaning In Progress Sample has been identified and is currently being sampled for programmed tests. Incomplete Sample has completed all tests possible and has some tests which are still pending.
Page 202: Identifying Samples
Identifying Samples Introduction Identifying Samples Introduction Samples may be identified by a Sample ID or by a rack/cup position or both. Rack and Position Mode and Bar Code Mode setup options affect where the cursor starts within sample programming and which fields are required to save sample programs.
Page 203 Identifying Samples Limitations Limitations The instrument stores up to 10,000 unique Sample IDs. When this limit is exceeded, the system overwrites the oldest sample program. Duplicate Sample IDs are not allowed. If Sample IDs are reused by the laboratory, set the Maximum Sample Program Age feature to help alert you to conflicts.
Page 204 Identifying Samples Manually Assigning Rack and Position Manually Assigning Rack and Position It is only necessary to manually assign a rack and position if: • the system is set up in bar code mode and a sample will not be bar coded, •...
Page 205: Selecting Tests
Selecting Tests Introduction Selecting Tests Introduction Tests can be manually selected at the instrument using several methods: • by programming panels. • by typing the chemistry configuration number(s) in the chemistry entry box. • by selecting the chemistry button(s). Chemistry Identifiers Color is used to indicate chemistry information.
Page 206: Programming Functions
Programming Functions Introduction Programming Functions Introduction Entering a dilution factor and programming a Manual Overrange Detection and Correction (ORDAC) feature are discussed below. Entering a Dilution Factor A dilution factor may be entered to be applied to the results of a specified sample. The dilution factor represents an off-line dilution prepared by the operator.
Page 207: Batch Programming
Batch Programming Introduction Batch Programming Introduction Batch Programming provides programming of multiple samples with the same chemistries, sample type, dilution factor, and status. Any Panel, Comment, Demographics, Dilution Factor, Sample Type, or Chemistry programmed will apply to all sample positions designated within the batch. This information may be edited at any time on an individual position basis once the batch programming is completed.
Page 208 Batch Programming Batch Programming Step Action , continued A batch may be programmed with Sample IDs only, rack/cup designations only or both, as follows: Identification Procedure Rack/cup with Sample IDs Type rack numbers and number of samples desired in the batch. Select <OK>...
Page 209: Chapter 8 Results Recall
Overview Introduction CHAPTER 8 Results Recall Overview Introduction Results Recall allows patient and control results to be recalled, reviewed, updated, and printed. Results can be recalled, viewed, and printed by: • individual Sample ID or a list of Sample IDs •...
Page 210: Recalling Results By Sample Id
Recalling Results by Sample ID Introduction Recalling Results by Sample ID Introduction Results can be recalled by an individual Sample ID and/or by a range of Sample IDs. Recalling by Sample ID Individual Sample IDs and/or a range of Sample IDs can be entered. Data and results may be reviewed and/or sent to the host.
Page 211: Recalling Results By Rack And Position
Recalling Results by Rack and Position Introduction Recalling Results by Rack and Position Introduction Results can be recalled by rack and position. Recalling by Rack and Position Follow the steps below to enter rack(s) and position(s) for recall. Step Action Select the Results icon from the menu bar.
Page 212 Recalling Results by Rack and Position Recalling by Rack and Position Step Action , continued Select a function button from the bottom of the screen to select a desired output option. • Results [F1] - to view results on the screen. •...
Page 213: Recalling Results By Patient Id
Recalling Results by Patient ID Introduction Recalling Results by Patient ID Introduction Results can be recalled by Patient ID. Recalling by Patient ID Follow the steps below to recall a result by Patient ID. Step Action Select the Results icon from the menu bar. From the Recall Results By screen, type the Patient ID (a maximum of 15 alphanumeric characters) in the Patient ID field.
Page 214: Recalling Results By Run Date/Time
Recalling Results by Run Date/Time Introduction Recalling Results by Run Date/Time Introduction Results can be recalled by Run Date and/or Time. Recalling by Run Date/Time Follow the steps below to recall results by Run Date and/or Time. Step Action Select the Results icon from the menu bar. From the Recall Results By screen, type the desired date and time ranges in the From fields and To fields.
Page 215: Displaying Recalled Results
Displaying Recalled Results Introduction Displaying Recalled Results Introduction All recalled results may be viewed on the screen. Displaying Results Follow the steps below to view results on the screen. Step Action From the Recall Results By screen, select the results to be viewed, as previously described in this chapter.
Page 216: Critical Result Rerun Editing
Critical Result Rerun Editing Introduction Critical Result Rerun Editing Introduction When a sample is rerun, the two results are shown in the Recall Results screen. The first result is always listed at the top and the rerun result is listed under the first result. The operator can delete one of the results and keep the other result.
Page 217 Critical Result Rerun Editing Deleting a Critical Rerun Result Step Action , continued Select Prev [F8] to view a previously shown sample. Select Next [F9] to view other samples if more than one sample result was recalled. Select Done [F10] when completed. (2 of 2) UniCel DxC Systems Instructions For Use A13914 Results Recall...
Page 218: Printing Recalled Results
Printing Recalled Results Introduction Printing Recalled Results Introduction All recalled results may be printed. Printing a Recalled Result Follow the steps below to print a recalled result. Step Action Select the Results icon from the menu bar. To print using... Then...
Page 219: Sending Results To The Host
Sending Results to the Host Introduction Sending Results to the Host Introduction Results may be sent to the host in two ways: • Recalling and sending whole parcels of data. • Recalling and sending individual results. How to Send Parcels of Data Follow the steps below to recall results to the host.
Page 220: Absorbance Versus Time
Absorbance Versus Time Introduction Absorbance Versus Time Introduction To get data to help troubleshoot completed chemistry results, use the Absorbance versus Time feature. Get Data To get data, follow the steps below. Step Action Recall the results of the desired sample (use any of the Results Recall criteria described in the previous sections).
Page 221: Statistical Summary Report
Statistical Summary Report Introduction Statistical Summary Report Introduction The Statistical Summary Report feature allows the user to select a range of samples that will produce a calculated mean, Standard Deviation, and Coefficient of Variation for a group of selected samples. The information is automatically printed out on a report.
Page 222 Statistical Summary Report Displaying Statistical Summary Results Recall UniCel DxC Systems Instructions For Use A13914 Page 8-14 October 2005...
Page 223: Chapter 9 User Defined Reagents
System Setup. Chemistries can then be configured on the test selection menu for programming along with the Beckman Coulter-defined chemistries. When configured, quality control, reference ranges, and special calculations may be used with these configured chemistries.
Page 224: Requirements And Precautions
NOTICE Since Beckman Coulter does not manufacture or otherwise control the reagents that may be used in user defined reagent cartridges, Beckman Coulter makes no warranty whatsoever with respect to such reagent's performance (including test results), their effect on the system or required system maintenance or the frequency thereof, or their effect on operator safety.
Page 225 Requirements and Precautions User Defined Reagent Cartridges NOTICE Non-Beckman Coulter reagents, calibrators, and controls can contain components, not listed on the insert, which may carry over into the system causing chemical or spectral interference. This carryover could adversely affect results on a properly performing system. Manufacturers of user-defined reagents should be contacted for disclosure of potentially interfering substances, such as preservatives.
Page 226: User-Defined Reagent Setup
User-Defined Reagent Setup Defining a User-Defined Reagent User-Defined Reagent Setup Defining a User-Defined Reagent Step Action Select the Setup icon from the menu bar. Select <15> User-Defined Chemistries. Select the Number to be defined. Type a number in the Option Number field and press [Enter]. Select Define [F1].
Page 227: Chemistry Parameters
Chemistry Parameters Defining a Chemistry Test Name Chemistry Parameters Defining a Chemistry Test Name A test name cannot begin with a numeric entry or be defined the same as an existing chemistry test name. The test name is stored and retrieved in upper case letters only. The designated test name is used as the chemistry code as described in the UniCel DxC Synchron Clinical Systems Host Interface Specifications.
Page 228 Chemistry Parameters Units Units Changing previously defined units for a user defined reagent is not allowed if the chemistry is included in a current control definition. In addition, changing units will invalidate recalled results and delete associated reference ranges. Table 9.4 Options for Units 1.
Page 229 Chemistry Parameters Math Model Math Model Refer to CHAPTER 2, Theory of Operation, Modular Chemistry: Calibration Theory, in the UniCel DxC Synchron Clinical Systems Reference Manual for a detailed explanation of each selection. Table 9.7 Options for Math Models Linear Math Model 1 - 4 Parameter Log-logit function Math Model 2 - 5 Parameter Logit function Math Model 3 - 5 Parameter Exponential function...
Page 230 Chemistry Parameters Calculation Factor Calculation Factor A calculation factor should be entered if no calibrators are defined. If a calculation factor is not defined, the system will not accept the default value of 0, and the user must type 1. For downgoing reactions, the entry must be a negative number. Additional slope and offset adjustments may be made at the Reagent Status/ Calibration Status screen.
Page 231 Chemistry Parameters Number of Calibrators Number of Calibrators If no calibrators are used, type 0. A linear math model allows no more than two calibrators. A non-linear math model requires five or more calibrators. If two or more calibrators are used, span values are shown. If five or more calibrators are used, recovery and sensitivity statistics are also shown.
Page 232: Processing Parameters
Processing Parameters First Inject: Component Processing Parameters First Inject: Component The First Inject component designates the compartment of the cartridge which will be pipetted first. Table 9.14 Options for the First Inject Component A, B, or C First Inject: Dispense Volume The combined volume of all inject reagents must be between 200 and 327 µL.
Page 233 Processing Parameters Second Inject: Add Time Second Inject: Add Time Add Time programs the reagent dispense time into the cuvette. (Refer to Figure 9.1.) • The Second Inject may be added at the same time as First Inject or a minimum of 8 seconds after sample has been pipetted.
Page 234 Processing Parameters Second Inject: Add Time DxC 600/800 Timing Chart 3 to 6 minutes TIME (SECONDS) Reagent Blank Read Window Second Inject Add Time (T = -180, 9 to 738) Third Inject Add Time (T = -172, 9 to 738) Reaction Read Windows T = -180 T = -172...
Page 235 Processing Parameters Third Inject: Component Third Inject: Component This designates the compartment of the cartridge which will be pipetted third. If Third Inject is not used, the compartment selection is None and should not be modified. Table 9.19 Options for the Third Inject Component None, A, B, or C Third Inject: Dispense Volume The combined volume of all inject reagents must be between 200 and 327 L.
Page 236 Processing Parameters Blank Read Times Blank Read Times Blank read times indicate when the blank absorbance is to be read. • Time -180 to -1 is a reagent blank. • Time 1 is when sample is added to the cuvette. •...
Page 237 Processing Parameters Usable Result Range Table 9.25 Reaction Read Times Allowable Entries Single Cycle Test Double Cycle Test Start Read 1 to 1704 seconds 1 to 1604 seconds End Read 1 to 1720 seconds 721 to 1620 seconds Overall system throughput is decreased. Cuvettes next to the test cuvette are left empty to prevent the test cuvette from being washed in the first cycle.
Page 238: Error Detection Limits
Error Detection Limits Reagent Blank (Absorbance or Rate) Error Detection Limits Reagent Blank (Absorbance or Rate) Reagent blank specifies the minimum and maximum absorbance or rate (method dependent) for the reagent blank measured during the blank read window. If these values are exceeded, the results are suppressed and flagged as blank absorbance/rate high (BL ABS HI or BL RATE HI) or blank absorbance/rate low (BL ABS LO or BL RATE LO).
Page 239 Error Detection Limits Initial Rate High and Substrate Depletion Initial Rate High and Substrate Depletion The initial rate parameter specifies maximum rate of absorbance change measured within the first cycle after the last component (sample or reagent) is added. When this value is exceeded, results will be suppressed and flagged Initial Rate High (INT RATE HI).
Page 240: Wavelength Selection
Wavelength Selection Introduction Wavelength Selection Introduction The UniCel DxC 600/800 provides a selection of ten wavelengths ranging throughout the UV-visible spectral region from which to measure the absorbance of a desired analyte. These are 340, 380, 410, 470, 520, 560, 600, 650, 670, and 700 nm. In order to run a user-defined reagent, two wavelengths are required: the primary or analysis wavelength, and the secondary or reference wavelength.
Page 241 Wavelength Selection Summary Summary • A secondary wavelength closer to the primary wavelength reduces noise and increases accuracy. • Obtaining the maximum absorbance difference increases sensitivity. • Avoid secondary wavelengths with peak spectral interferences within the primary spectral curve. • Select a secondary wavelength that produces a net absorbance that is close to the net absorbance of the primary wavelength.
Page 242: Determination Of Extinction Coefficients
Determination of Extinction Coefficients Introduction Determination of Extinction Coefficients Introduction In general, there are two ways to determine the molar absorptivity or extinction coefficient "e" for a given chemistry at each of the wavelengths required for analysis. Option 1 Prepare a stock, standard solution of the chromophore. From this stock solution, prepare a working standard solution at the same molar concentration recommended by the reagent manufacturer.
Page 243: Exit Check Criteria
Exit Check Criteria Introduction Exit Check Criteria Introduction When preparing to save a chemistry protocol after editing, the parameters are checked for correctness, completeness, and consistency. Chemistry protocols that fail any Exit Check criteria are not allowed to run. The following requirements specify the Exit Check criteria and parameters presented for modification when the user elects to correct detected protocol errors.
Page 244 Exit Check Criteria Measurement Measurement • The reaction end-read time must exceed the reaction start-read time by a minimum of one processing cycle. • The reaction absorbance high limit must be greater than the reaction absorbance low limit. • The usable range upper limit must be greater than the usable range lower limit. Volumes •...
Page 245: User Defined Reagent Removal
User Defined Reagent Removal Removing a User Defined Reagent User Defined Reagent Removal Removing a User Defined Reagent Follow the steps below to explain how to clear a user-defined reagent. Step Action Remove UDR reagent cartridge from system. Delete UDR information from the following areas: reference ranges, calibration assignments, sample programming and quality control.
Page 246 User Defined Reagent Removal Removing a User Defined Reagent User Defined Reagents UniCel DxC Systems Instructions For Use A13914 Page 9-24 October 2005...
Page 247: Chapter 10 Maintenance
Overview Introduction CHAPTER 10 Maintenance Maintenance Overview Overview Introduction Maintenance on the UniCel DxC System should be performed by trained personnel to insure continued, optimal performance and to reduce unnecessary service calls. Minimum training requires that the operator read the Maintenance procedures. The Scheduled Maintenance Log feature allows the system to keep track of what maintenance is needed, when it is needed, and who performed the procedure.
Page 248 Overview Common Abbreviations Common Abbreviations CC – Cartridge Chemistry side of the system MC – Modular Chemistry side of the system ISE – Ion Selective Electrode (Flow Cell Module) EIC – Electrolyte Injection Cup CCWA – Cartridge Chemistry Wash Solution CTS –...
Page 249 Overview Two-Month Maintenance Two-Month Maintenance • Replace CTS Blade/Wick (CTS option only) • Change/Clean Air Filters Three-Month Maintenance • Replace Syringe Plungers Four-Month Maintenance • Clean MC Reagent Lines Six-Month Maintenance • Replace CALC Electrode Tip • Replace K Electrode Tip •...
Page 250: Electronic Maintenance Log
Electronic Maintenance Log Feature Summary Electronic Maintenance Log Feature Summary Maintenance items are grouped together by frequency of performance. Only the maintenance items appropriate for the particular system and installed hardware are shown. For example, a system that does not have Closed Tube Sampling (CTS) hardware will not show the maintenance items for that hardware.
Page 251 Electronic Maintenance Log Accessing the Scheduled Log Feature NOTICE It is recommended to back up maintenance files onto a diskette at scheduled intervals. Refer to CHAPTER 12, Utilities for Backup/Restore instructions. Electronic Maintenance data may also be printed and stored if required by laboratory policy.
Page 252 Electronic Maintenance Log Procedure Select All This function allows all of the maintenance procedures available on the screen to be selected for initial and date entry all at once. (See initial and date feature below). Initial and Date Check Box Once a maintenance procedure has been completed selecting this function allows the operator to select that procedure for entry of the initials of the person performing the procedure and the date it was performed.
Page 253 Electronic Maintenance Log Procedure History Selecting this option provides a stored history of maintenance performance with dates and initials for the procedure selected. Initial and Date Button Once a procedure has been selected for initial and date using the check box as described above selecting this button will allow the appropriate information to be entered.
Page 254: Weekly Maintenance
Weekly Maintenance Check Reagent Levels Weekly Maintenance Check Reagent Levels Check the levels of these MC reagents: Wash Concentrate II, No Foam and CTS Auto- Gloss (CTS option only). To check the levels, perform the following steps: Step Action Select the Rgts/Cal icon from the menu bar. Select the down arrow button to review the second page screen.
Page 255 Weekly Maintenance Replace Cuvette Wiper Replace Cuvette Wiper With constant use, the cuvette wiper can deteriorate and become stained and torn. The cuvette wiper should be changed weekly or as needed to maintain the cleanliness and integrity of the cuvette. Step Action Remove the cuvette wash station cover.
Page 256 Weekly Maintenance Clean Total Protein and Albumin Cup Modules (DxC 800 Only) Step Action , continued Install new wiper (1) by sliding it onto the bottom of the probe until the under surface of the wiper is flush with the end of the probe. Note: The wiper tip should be square to the cuvette.
Page 257 Weekly Maintenance Clean Total Protein and Albumin Cup Modules (DxC 800 Only) Cleaning Preparation Prepare the following solutions before beginning the cleaning procedure: 1N HCL solution Combine one part 6N HCL and five parts of deionized water for cleaning Total Protein cup. 10% Cleaning Solution Combine one part Wash Concentrate II with nine parts of deionized water for cleaning Albumin cup.
Page 258 Weekly Maintenance Clean Probes (Exterior) Step Action , continued Calibrate Total Protein and Albumin chemistries and run QC materials. NOTICE A lamp calibration should be performed after Total Protein and Albumin cup maintenance on a MONTHLY basis. You are not required to perform the ALBm and TPm lamp calibration following the Weekly maintenance.
Page 259 Weekly Maintenance Clean Probes (Exterior) Step Action , continued To access the lower portions of the CC reagent probes (under the attached wash collars) remove the reagent carousel cover, then • Move the reagent probes from the home position to the maintenance indentation (1).
Page 260 Weekly Maintenance Clean Probes (Exterior) Step Action , continued To access the lower portions of the MC and CC sample probes (under the attached wash collars) remove the sample carousel cover. To continue access: • Move the sample probes to a clear space (1) between the sample carousel racks and the sample carousel tub.
Page 261 Weekly Maintenance Clean Flow Cell and Cups Clean Flow Cell and Cups Clean the flow cell and cups as follows: Step Action Select the Utils icon from the menu bar. From the Utilities dialog box, select <2> Maintenance. Type 2 in the Option Number field and press [Enter]. Select <10>...
Page 262 Weekly Maintenance CC Probe Cleaning Step Action , continued Program 15 replicates of diluted Clenz Solution and 10 replicates of saline by selecting: • the Samples icon from the menu bar. From the Program Sample screen: • Type the desired rack number and press [Enter]. •...
Page 263 Weekly Maintenance Check Chloride Calibration Span Check Chloride Calibration Span Check the chloride calibration span as follows: Step Action During the daily calibration routine, the AQUA CAL 2 Calibration Report is automatically printed. Obtain this printout. Refer to page 2 of the calibration report. Check the CL span value at the bottom of the page.
Page 264: Monthly Maintenance
Monthly Maintenance Replace Alkaline Buffer Monthly Maintenance Replace Alkaline Buffer The following procedure describes how to replace the Alkaline Buffer reagent and the the In-line air filters. Step Action Loosen the two Phillips screws on the ISE module cover and remove the cover.
Page 265 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Remove reagent input line #30 (1) (line draining into damper) from the top of the in-line filter. Figure 10.7 Twist off the in-line filter (P/N 669212) from the input line and replace. Note: When installing in-line filters, be sure the arrow on the filter is pointing in the direction of reagent flow.
Page 266 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Place a fresh bottle of alkaline buffer on the system. Wipe reagent straw and replace bottle cap onto the new reagent bottle. Figure 10.8 Load reagent information from bottle bar code into the system either automatically using the hand-held bar code reader, or manually using the keyboard.
Page 267 Monthly Maintenance Replace Alkaline Buffer Adjusting Fluid Level of the Alkaline Buffer Damper Assembly Step Action Visually inspect the damper to verify that the fluid level rests between the MIN and MAX lines, approximately one-third to one-half full. If the fluid level is below the MIN line, proceed to Step 2. If fluid level is above the MAX line, go to Step 8.
Page 268 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Clip the damper assembly back into the upright position. CAUTION Pinching Hazard. When lowering the ISE module, keep fingers clear. Lower the ISE module down into cavity and reinstall the ISE module cover.
Page 269 Monthly Maintenance Replace Alkaline Buffer Step Action , continued CAUTION Pinching Hazard. When lowering the ISE module, keep fingers clear. Release the locking pin on the left side of the ISE module and lower the module into the cavity until the pin clicks. Reinstall the ISE module cover. (3 of 3) Clean All Cup Modules Albumin, Urea Nitrogen, Glucose, Phosphorus, Creatinine, and Total Protein cup...
Page 270 Monthly Maintenance Replace Alkaline Buffer Step Action , continued NOTICE To prevent damage to either the BUNm/UREAm electrode or GLUCm sensor, do not insert transfer pipette or any other object down into the bottom of the cup. It is not required to remove the stir bars from any cup during this cleaning procedure.
Page 271 Monthly Maintenance Replace Alkaline Buffer Step Action Drain the reagent from the MC cups by selecting: • the Utils icon from the menu bar, • <2> Maintenance, • <4> Cup Maintenance. Select BUNm/UREAm to be drained in preparation for maintenance if performing BUNm/UREAm maintenance.
Page 272 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Press the latch, which is located on the connector (1), to disengage the electrode pin lead from the connector panel and remove the electrode connector from the socket. Figure 10.12 Unscrew the BUNm/UREAm electrode retainer nut (1) and withdraw the electrode-retainer assembly from the chemistry reaction cup.
Page 273 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Separate the electrode (3), retainer (2) and retainer nut (1). (Refer to Figure 10.14.) Note: It is not required to clean the stir bar, however, the stir bar may be cleaned if desired while the BUNm electrode is removed from the cup. Refer to Four Month Maintenance, "Cleaning MC Reagent Lines", section...
Page 274 Monthly Maintenance Replace Alkaline Buffer Step Action , continued Use lintless tissue moistened with deionized water to clean the electrode face until the gold surface is bright. Rub parallel to the gap (1) with tissue. Rinse with deionized water. Dry using lintless tissue. Figure 10.15 Apply a thin coating of Silicone Compound (P/N 879049) over the tip of the electrode.
Page 275 Monthly Maintenance Calibrate Lamps and Sensor Step Action , continued Select <Close> when priming has completed to exit the pop-up Result window. Select <Prime5> to prime BUNm/UREAm 5 times with reagent. While the module is priming: • Observe the reagent line and reaction cup to confirm there are no leaks. If any leaks are noticed correct the problem.
Page 276 Monthly Maintenance Calibrate Lamps and Sensor Step Action , continued Select <8> CUPs Lamp/Sensor Calibration. Type 8 in the Procedure No. field and press [Enter]. To calibrate Albumin, Creatinine, Phosphorus, and Total Protein (DxC 800 only): Select the ALBm, CREm, PHOSm, and TPm Lamp Calibration check boxes.
Page 277 Monthly Maintenance Clean Mixers Reassembling MC Components After all maintenance procedures are complete on the MC (all electrodes have been serviced), follow the steps below to reassemble the MC. Step Action Carefully replace MC cover over reaction cup modules and tighten screws. NOTICE While the ISE cover is removed, for maximum efficiency, the Adjusting Fluid Level of the Alkaline Buffer Damper Assembly procedure (in this...
Page 278 Monthly Maintenance Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) A015939P.EPS 1. CC Sample Mixer 2. CC Reagent Mixer Figure 10.16 CC Sample and Reagent Mixers Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) Refer to Figure 10.17. Replace the Cap Piercer blade approximately once a month. If the system runs >500 samples per day, replace the blade more frequently.
Page 279 Monthly Maintenance Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) Material Required: • Medium straight-edge screwdriver Replacement Procedure In the following procedure, the old blade is removed in Steps 1–5 and the new blade is installed in Steps 6–11. Step Action To access this procedure, select:...
Page 280 Monthly Maintenance Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) Step Action , continued CAUTION The points of the Blade are very sharp and extend below the Wash Tower. Stay away from the bottom of the Wash Tower. CAUTION DO NOT select <OK>...
Page 281 Monthly Maintenance Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) Step Action , continued Refer to Figure 10.19. • Fully loosen the one captive blade screw (2). • Fully loosen the two captive blade holder screws (1). • Remove the blade holder. A014850P.EPS Figure 10.19 •...
Page 282 Monthly Maintenance Replace CTS Blade (Sarstedt S-Monovette Type CTS Option only) Step Action , continued Carefully move the points of the blade down through the wash tower and through the alignment slot at the bottom: • Push down on the blade holder screws and align them over their holes. •...
Page 283: Two-Month Maintenance
Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Refer to Figure 10.20. Replace the Cap Piercer blade and its CTS Auto-Gloss wick approximately every two months. If the system runs >500 samples per day, replace the blade and wick more frequently.
Page 284 Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Step Action To access this procedure, select: • the Utils icon from the menu bar • <2> Maintenance • <1> 1-Blade Thick CTS Blade Replacement To start the procedure, select <Continue>. To exit this screen, select <Cancel>. The instrument prepares for blade and wick replacement.
Page 285 Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Step Action , continued Refer to Figure 10.22. • Fully loosen the one captive blade screw (2). Push down on this screw until the blade (3) separates from the blade holder (4). •...
Page 286 Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Step Action , continued Refer to Figure 10.23. Remove the blade clamp, blade (1), and wick (3) as follows: • Hold the blade (1) at the top of its shaft. Do not touch the points (2) of the blade.
Page 287 Two-Month Maintenance Replace CTS Blade/Wick (CTS Option only) Step Action , continued Refer to Figure 10.24. Hold the blade holder (5) with the blade clamp hole (3) on the top as shown below. Note that the blade clamp hole (3) is keyed and the blade clamp (2) has a slot.
Page 288 Two-Month Maintenance Change/Clean Air Filters Step Action , continued Refer to Figure 10.21. Install the Cap Piercer cover and tighten the two captive Cap Piercer cover screws (1). Select <OK>. • The system sets the blade count to zero. • The Cap Piercer carriage moves up to home position. •...
Page 289 Two-Month Maintenance Change/Clean Air Filters Step Action , continued Lower the clean, dry filters back into position on each door, placing the small filters (1) on top and the large filter (2) on the bottom. Note: Slide each filter into position so that the metal grating faces towards the inside of the instrument when doors are closed.
Page 290: Three-Month Maintenance
Three-Month Maintenance Replace Syringe Plungers Three-Month Maintenance Replace Syringe Plungers The one reagent and two sample syringe plunger rod assemblies should be replaced every three months or when signs of wear (discoloration, flaking tips, etc.) are noticed. The Syringe Plunger replacement procedures apply to the CC Reagent Syringe, the MC Sample Syringe, and the CC Sample Syringe.
Page 291 Three-Month Maintenance Replace Syringe Plungers A015943P.EPS 1. MC Sample Syringe 2. CC Sample Syringe Figure 10.27 MC and CC Sample Syringes (100 µL) Preparing for Maintenance Mode and Removing the Plunger Before removing the plunger, the plunger rods must be fully extended to the bottom of the syringe barrels.
Page 292 Three-Month Maintenance Replace Syringe Plungers Step Action , continued The syringe rods (1) are now positioned for placement. A015944P.EPS Figure 10.28 • Unscrew the barrel of the reagent syringe (left back wall) or barrels of two sample syringes (back wall above modular cups) to release each syringe.
Page 293 Three-Month Maintenance Replace Syringe Plungers Step Action , continued Separate the plunger rod (3) from the barrel (1) by unscrewing the brown plunger guide (2) at the base of the barrel and pull the plunger rod out of the barrel. Discard the old plunger rod (with its guide and base). Note: The plunger rod cannot be pulled through the brown plunger guide.
Page 294 Three-Month Maintenance Replace Syringe Plungers Step Action , continued CAUTION When installing the syringes, do not mix the two different syringe sizes. The MC and CC sample syringes (100 µL) are located on the back wall of the instrument. The CC reagent syringe (500 µL) is located on the right side of the instrument.
Page 295 Three-Month Maintenance Replace Syringe Plungers Priming the Syringes Step Action Prime syringes 10 times by selecting: • the Utils icon from the menu bar, • <1> Prime, • CC [F2], • Reagent and/or Sample Delivery Subsystem, • 10 in the Number of primes to repeat field, •...
Page 296: Four-Month Maintenance
Four-Month Maintenance Cleaning MC Reagent Lines Four-Month Maintenance Cleaning MC Reagent Lines The MC Reagent Lines, Cups, and Stir Bars Cleaning procedure should be performed every four months for ALBm, BUNm/UREAm, CREm, GLUCm , PHOSm, and TPm. More frequent cleaning may be required if erratic results, low results, or reagent cups not filling are experienced.
Page 297 Four-Month Maintenance Cleaning MC Reagent Lines Cleaning the MC Lines, Cups, and Stir Bars Step Action Select: • the Utils icon from the menu bar, • <2> Maintenance, • <4> Cup Maintenance. Open the left side MC Reagent Compartment door and remove the straws from the reagent bottles: ALBm, BUNm/UREAm, CREm, GLUCm, PHOSm, and TPm.
Page 298 Four-Month Maintenance Cleaning MC Reagent Lines Step Action , continued When priming is complete, insert each reagent straw back into the appropriate reagent bottle. Verify that the reagent straws are seated properly and reach down into the reagent. Make sure all reagent bottle caps are securely tightened and no reagent lines are crimped or pinched.
Page 299 Four-Month Maintenance Cleaning MC Reagent Lines Step Action , continued CAUTION Remove the Glucose sensor before removing the stir bar. To prevent damage to the glucose sensor membrane tip, do not insert the stir bar removal tool, applicator stick, or any other object into the glucose reaction cup unless the sensor has been removed.
Page 300 Four-Month Maintenance Cleaning MC Reagent Lines Step Action , continued CAUTION Make sure the BUNm/UREAm electrode is slightly withdrawn before reinstalling the stir bar. This prevents possible damage to the delicate electrode tip. After the stir bar is reinstalled, tighten the retainer nut to prevent leakage.
Page 301: Six-Month Maintenance
Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Six-Month Maintenance Replace Calcium and Potassium Electrode Tip The following procedures apply to the preparation and replacement of calcium and potassium electrodes that are housed in the flow cell. The operator may choose to replace one or both electrode tips at the same time.
Page 302 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Step Action , continued Lower electrode tip with the membrane face down into the soaking solution until it floats. For maximum initial operational stability, the ideal soaking time is 24 hours. The minimum required time is one hour. Note: If maximum soaking time is not allowed, the new electrode may require a few hours of operation to achieve complete electrical stability.
Page 303 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip ISE Service The ISE service procedure prevents reagent leakage from the flow cell whenever electrode removal is required. Step Action Loosen the two Phillips screws (1) on the ISE module cover and lift off cover.
Page 304 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Step Action , continued Prevent leakage of reagent from the flow cell by selecting: • the Utils icon from the menu bar, • <2> Maintenance, • <3> ISE Service, • <Continue>. The flow cell is prepared for electrode maintenance. Refer to the appropriate electrode procedures for servicing other electrodes (As-Needed/As-Required Maintenance).
Page 305 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Step Action Disconnect the electrode cable from potassium connector (1) and calcium connector (2). Figure 10.36 Loosen the flow cell retaining screw (1) located at the top of the flow cell. This is a captive screw and cannot be removed from the flow cell. Pull assembly forward and upward to remove.
Page 306 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Step Action , continued Locate Potassium electrode (1). Remove electrode by turning the electrode retaining nut counterclockwise. AND/OR Locate Calcium electrode (2). Remove electrode by turning the electrode retaining nut counterclockwise. Figure 10.38 Remove the retainer nut from the old electrode.
Page 307 Six-Month Maintenance Replace Calcium and Potassium Electrode Tip Step Action , continued Install a new O-ring on the presoaked potassium and/or calcium electrode tip and screw onto electrode body. Install the new quad-ring on the tip of the new electrode. Thoroughly dry the electrode port with lintless tissue.
Page 308 Six-Month Maintenance Replace Glucose Sensor Step Action , continued Following calcium electrode tip replacement and calibration: • Program and run at least 20 replicates of serum samples for CALC. • Recalibrate calcium. (4 of 4) Replace Glucose Sensor ® The Synchron AccuSense glucose oxygen sensor requires no assembly.
Page 309 Six-Month Maintenance Replace Glucose Sensor Step Action , continued Hold the sensor in a vertical position with the membrane tip pointed upward. Tap on the side of the sensor body to remove any bubbles from membrane tip. Remove the ISE module and MC module covers. Push the glucose sensor connector into the empty connector port (1) of the BUNm/UREAm module until the latch clicks.
Page 310 Six-Month Maintenance Replace Glucose Sensor Step Action Drain the reagent from the MC cup by selecting: • the Utils icon from the menu bar, • <2> Maintenance, • <4> Cup Maintenance. Select Glucose cup to be drained in preparation for maintenance. Select <Drain>.
Page 311 Six-Month Maintenance Replace Glucose Sensor Step Action Remove the ISE module and MC module covers. Press the latch (1), which is located on the connector and pull out, to disconnect sensor pin lead from connector panel. Figure 10.41 • Unscrew the sensor retainer nut (1) and withdraw sensor assembly from chemistry reaction cup.
Page 312 Six-Month Maintenance Replace Glucose Sensor Step Action , continued CAUTION Reaction cup and stir bar cleaning is recommended whenever the sensor is replaced. Remove the sensor prior to removing stir bar. To prevent damage to the glucose oxygen sensor membrane tip, do not insert stir bar removal tool, applicator stick, or any other object into the glucose reaction cup unless the sensor has been removed.
Page 313 Six-Month Maintenance Replace Glucose Sensor Step Action , continued Select <Close> when priming has completed to exit the pop-up Result window. Select <Cancel> to return to the Maintenance menu. Reinstall the MC module and ISE module covers. Proceed to the "Calibrate Lamps and Sensor"...
Page 314: As-Needed/As-Required Maintenance
As-Needed/As-Required Maintenance Introduction As-Needed/As-Required Maintenance Introduction As-Needed/As-Required Maintenance contains miscellaneous maintenance procedures which may be performed on an as-needed basis or procedures that may be performed on a regular basis as preventive service maintenance. The As-Required Maintenance includes items that are maintained on an interval schedule, and are normally performed as preventive service maintenance.
Page 315 As-Needed/As-Required Maintenance Replacing the Chloride Electrode Tip Step Action , continued To prevent reagent leakage from the flow cell, select: • the Utils icon from the menu bar, • <2> Maintenance, • <3> ISE Service, • <Continue>. The flow cell is prepared for electrode maintenance. Proceed to Replacing the Chloride Electrode below.
Page 316 As-Needed/As-Required Maintenance Replacing the Chloride Electrode Tip Step Action Loosen the flow cell retaining screw (1) located at the top of the flow cell. This is a captive screw and cannot be removed from the flow cell. Pull assembly forward and upward to remove. NOTICE Do not disconnect any of the reagent lines attached to the flow cell.
Page 317 As-Needed/As-Required Maintenance Replacing the Chloride Electrode Tip Step Action , continued Remove the retainer nut from the old electrode. Remove the quad-ring (1) from the tip of the old electrode. Inspect the electrode port if the quad-ring is not on the electrode. Discard the quad-ring. Figure 10.45 Unscrew the old tip from the electrode assembly.
Page 318 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Step Action , continued When system has completed priming, select <Close> to exit the procedure. CAUTION Pinching Hazard. When lowering the ISE module, keep fingers clear. Lower the ISE module down into the cavity by releasing the locking pin. Be careful not to pinch any tubing as the ISE module is lowered.
Page 319 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Step Action In a small beaker, prepare a soft bottom lining using crumpled multiple layers of Na/K-free filter paper (2). Pour ISE Reference solution (do not dilute) into the beaker to a depth not to exceed two inches (50mm) (1).
Page 320 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode CAUTION To prevent damage due to electrical static discharge (ESD), wear a wrist ground strap when performing this procedure. For further instructions, refer "Basic Laboratory Practice" in the beginning of this chapter. Step Action Unscrew the two Phillips screws on the ISE Module cover and remove the cover.
Page 321 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Step Action , continued Using a hemostat, securely clamp Line #22 approximately one inch (25mm) from the top of the flow cell (1). This will prevent the back flow of reagent into the flow cell. NOTICE Do not disconnect any of the reagent lines attached to the flow cell.
Page 322 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Step Action , continued Loosen the flow cell retaining captive screw (1) located the top of the flow cell. Pull flow cell assembly forward. Figure 10.50 Unscrew (counterclockwise) the electrode retainer nut (1) and withdraw the electrode (2) from the flow cell.
Page 323 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Step Action , continued Examine the electrode tip. If an air bubble is seen inside the tip, hold the electrode cable near the end and spin the electrode for a few seconds. The bubble should be pushed back inside the electrode and remain there away from the tip.
Page 324 As-Needed/As-Required Maintenance Replacing the Sodium Measure/Reference Electrode Restarting the Autoprime To restart the Autoprime, follow the steps below. Step Action Select <OK> in the Maintenance Confirmation window. Select <Close> in the Result window. Priming the Flow Cell To prime the flow cell, follow the steps below. Step Action Prime the flow cell by selecting:...
Page 325 As-Needed/As-Required Maintenance Replacing the CO Membrane Replacing the CO Membrane The permeability of the CO membrane may change depending on usage and time. Changes in the membrane could be caused by a coating build-up, wear, or general deterioration. Replace the CO membrane as needed whenever these conditions occur.
Page 326 As-Needed/As-Required Maintenance Replacing the CO Membrane Step Action , continued Locate the CO measuring electrode. Place absorbent tissue beneath the electrode port. Using hemostats, clamp off reagent Lines #33 (1) and #32 (2) as closely as possible to the CO electrode.
Page 327 As-Needed/As-Required Maintenance Replacing the CO Membrane Step Action , continued Remove electrode retainer nut (1). Remove membrane as follows: • Separate the membrane retainer (3) assembly from the electrode. • Remove the quad-ring (4) from the retainer. Inspect the electrode port if the quad-ring is not on the electrode.
Page 328 As-Needed/As-Required Maintenance Replacing the CO Membrane Preparing the New CO Measuring Electrode Membrane Step Action Using tweezers, remove a new membrane (P/N 661750) from package in the Maintenance Kit. Rinse the membrane thoroughly, on both sides, with deionized water. Gently dry the membrane with lintless tissue. Note: Use the packaged membranes that are separated by pink spacers.
Page 329 As-Needed/As-Required Maintenance Replacing the CO Membrane Step Action , continued Center the membrane retainer (1) over the membrane clamp (3). Press the membrane retainer into the clamp, thus securing the membrane (2). Figure 10.58 Place the retainer assembly upside down on the work surface so the clamp is on top and retainer on the bottom.
Page 330 As-Needed/As-Required Maintenance Replacing the CO Membrane Step Action , continued Inspect the membrane to verify that it is not broken, or wrinkled and is centered properly with no uneven edges protruding. If membrane is not centered correctly or is damaged, repeat Steps 1-4 with a new membrane. Figure 10.60 CAUTION Do not touch membrane surface when installing the quad-ring.
Page 331 As-Needed/As-Required Maintenance Replacing the CO Membrane Reinstalling the CO Measuring Electrode Step Action Measuring Electrode Reinstallation Using a lintless tissue, carefully and thoroughly dry the electrode assembly and electrode port. Note: Electrode and electrode port must be completely dry before reinstallation of the electrode.
Page 332 As-Needed/As-Required Maintenance EIC Port Cleaning EIC Port Cleaning Flushing of the EIC ports should be performed if the Electrolyte Injection Cup (EIC) becomes plugged and overflows, or as part of troubleshooting for erratic electrolyte results. The following items should be available before starting this procedure: •...
Page 333 As-Needed/As-Required Maintenance EIC Port Cleaning Step Action , continued Disconnect the solenoid valves, located on each side of the EIC, at the valve connector (1) as shown below on DxC 800 Systems. The connector is located near the EIC ports where the ends of the two solenoid valve cables meet.
Page 334 As-Needed/As-Required Maintenance EIC Port Cleaning Step Action , continued Place absorbent tissue underneath the EIC port area. Place clamps or hemostats on lines #18 (1), #24 (2), #23 (3), and #26 (4), near the EIC ports. Remove EIC lines from all the ports #18, #24, #23, #26, and #15 (5). Figure 10.64 Carefully loosen the two screws (1) from the solenoid valve located on the back side of the EIC.
Page 335 As-Needed/As-Required Maintenance EIC Port Cleaning Step Action , continued Hold the removed EIC over a sink or absorbent tissue. Using a 20 or 30 mL irrigation syringe filled with 10% bleach solution, insert the tip of the syringe into the valve port opening (1). Figure 10.66 Flush the 10% bleach solution through the valve port.
Page 336 As-Needed/As-Required Maintenance EIC Port Cleaning Step Action , continued Using the syringe filled with 10% bleach solution, connect the syringe tip over the flow cell exit port #23 (1). Figure 10.67 Flush the 10% bleach solution through the flow cell exit port. This flushes the area between the valve port and flow cell exit port.
Page 337 As-Needed/As-Required Maintenance EIC Port Cleaning Step Action , continued Reinstall the solenoid valve to the back side of the EIC. Orient the valve to align the guide pins (1) on the valve with the appropriate holes (2) on the EIC. Press the EIC and valve firmly together for a flush fit. Tighten the two screws on the valve, turning the screws until resistance is felt.
Page 338 As-Needed/As-Required Maintenance Cleaning CO Alkaline Buffer Lines Step Action , continued CAUTION Pinching Hazard. When lowering the ISE module, keep fingers clear. Release the locking pin and lower the ISE module into the cavity. Reinstall the ISE module cover. Calibrate the ISE chemistries. (7 of 7) Cleaning CO Alkaline Buffer Lines...
Page 339 As-Needed/As-Required Maintenance Cleaning CO Alkaline Buffer Lines Step Action , continued Prime the ISE CO Alkaline Buffer 20 times by selecting: • the Utils icon from the menu bar, • <1> Prime, • MC [F4], • ISE CO Alkaline Buffer check box. Type 20 in the Number of primes to repeat field.
Page 340 As-Needed/As-Required Maintenance Cleaning the ISE Drain Step Action , continued CAUTION Pinching Hazard. When lowering the ISE module, keep fingers clear. Lower the ISE module into the cavity and reinstall the ISE module cover. Calibrate CO chemistry. (3 of 3) Cleaning the ISE Drain With constant use, the flow cell drain can develop a salt bridge, possibly causing recovery anomalies for NA and CL.
Page 341 As-Needed/As-Required Maintenance Cleaning the ISE Drain Step Action , continued Loosen the screw at drain top (1). Gently grasp the ISE drain top and remove the top. Do not lose the attached metal drip screen (2). (The top may require slight wiggling back and forth to remove.) Figure 10.69 Carefully set aside the drain top (with tubing #22 attached).
Page 342 As-Needed/As-Required Maintenance Cleaning the ISE Drain Step Action , continued Reinstall the cleaned drain tube, or install a new drain tube (P/N 472698). Insert the drain tube down through the O-ring until it sits flush on the bottom of the ISE drain. Note: If the fit is too snug to insert the drain tube, it may be necessary to lubricate the O-ring on the inside of the lower drain.
Page 343 As-Needed/As-Required Maintenance Flow Cell Flushing (Manual) Flow Cell Flushing (Manual) Flushing the flow cell is recommended for troubleshooting drift, back-to-back errors and range errors that may be caused by plugs or debris lodged in the electrode ports. The following items should be available before starting this procedure: •...
Page 344 As-Needed/As-Required Maintenance Flow Cell Flushing (Manual) Step Action , continued Remove line #23 from the bottom of the flow cell. Attach the connector fitting (1) on the small diameter tubing, included in the Flow cell flush kit, to the syringe. Connect the open end of the tubing to the bottom of the flow cell.
Page 345 As-Needed/As-Required Maintenance Flow Cell Flushing (Manual) Step Action , continued Remove Line #35 from the top of the flow cell. Attach the connector fitting (1) of the large diameter tubing, included in the Flow cell flush kit, to the syringe. Connect the open end of the tubing to the top of the flow cell. Flush the buffer through.
Page 346 As-Needed/As-Required Maintenance ISE Flow Cell Cleaning Using Clenz Solution ISE Flow Cell Cleaning Using Clenz Solution The Flow Cell Cleaning procedure helps to maintain the performance of the ISE chemistries. The procedure should be performed if one or more of the following conditions is seen: •...
Page 347 As-Needed/As-Required Maintenance ISE Flow Cell Cleaning Using Clenz Solution Step Action Loosen the two Phillips screws on the ISE module cover and remove cover. Release the locking pin on the ISE module and lift the module until it clicks. Prepare the flow cell for maintenance by selecting: •...
Page 348 As-Needed/As-Required Maintenance Sample and Reagent Probe Flushing Step Action , continued Completely prime the flow cell by selecting: • the Utils icon from the menu bar, • <1> Prime, • MC [F4], • ISE ALL check box. Type 20 in the Number of primes to repeat field. Select <Start Prime>.
Page 349 As-Needed/As-Required Maintenance Sample and Reagent Probe Flushing To flush the probe assembly, follow the steps below. Step Action Press the STOP button on the instrument to stop all motors. Place a small cup under the collar wash of the probe to be flushed. Unscrew the upper fitting (1) above the bead assembly to disconnect the DI water line.
Page 350 As-Needed/As-Required Maintenance Replacing the Sample and Reagent Probe Additional Procedures If the level sense bead was not removed, no alignments are required. If the bead was removed, perform all the alignments for that probe as described in UniCel DxC Synchron Clinical Systems Reference Manual, System Tools. •...
Page 351 As-Needed/As-Required Maintenance Replacing the Sample and Reagent Probe Step Action , continued Pull downward first on the probe, then up and to the side to remove the probe from the collar wash. Check to make sure the o-ring is on the nut. If the O-ring stayed inside the level sense bead, bump it loose with a wooden applicator stick.
Page 352 As-Needed/As-Required Maintenance Replacing the Sample and Reagent Probe Step Action , continued Follow the appropriate alignment procedure as described in the UniCel DxC Synchron Clinical Systems Reference Manual, System Tools If... then perform the following alignments... the current probe is re- no alignments required.
Page 353 As-Needed/As-Required Maintenance Replacing the Sample and Reagent Probe A007375L.EPS 1. Sample Probe 4. Wash Port 2. Collar Wash 5. Probe tip is even to the bottom edge of the wash port 3. Waste Port Figure 10.75 CC and MC Sample Probe A007376L.EPS 1.
Page 354 As-Needed/As-Required Maintenance Cleaning CC Sample Probe, Reagent Probes and Mixers Cleaning CC Sample Probe, Reagent Probes and Mixers The following procedure describes the automated procedure to wash the CC sample and reagent probes and mixers. This routine will take the system approximately 15 minutes.
Page 355 As-Needed/As-Required Maintenance Cleaning the MC Sample Crane and Collar Assembly Step Action , continued Exit the Maintenance menu. NOTICE To resume autoprime and return the system to Standby, you must exit the Maintenance menu. Remove the CCWA cleaning solution cartridge. •...
Page 356 As-Needed/As-Required Maintenance Cleaning the MC Sample Crane and Collar Assembly Step Action , continued Fill the cup with bleach. Place it in the specified rack and position, and then place the rack in the autoloader. Select <Start>. System will automatically load the rack and the MC probe will aspirate sample.
Page 357 As-Needed/As-Required Maintenance Cleaning the Precipitate in PHOSm (DxC 800 Only) Cleaning the Precipitate in PHOSm (DxC 800 Only) The phosphorus (PHOSm) cup should be cleaned when protein precipitate accumulates at the top of the liquid surface. The precipitate may not clear from the cup upon draining causing noise flags to occur.
Page 358 (such as glass from a broken cuvette), the DxC may provide inaccurate results. If any of these steps fail, contact the Clinical Support Center or a local Beckman Coulter Representative to identify and resolve any suspected problems.
Page 359 As-Needed/As-Required Maintenance Inspecting the Cuvette Washer Probe Step Action , continued Observe the wash probe spray pattern during the prime. There should be three distinct and straight streams in a triangular pattern spraying from each probe. Note: If a pattern of distinct streams is not observed during prime, check for proper water pressure in the hydropneumatic system.
Page 360 As-Needed/As-Required Maintenance Washing All Cuvettes With System Wash Step Action , continued Position the probes 1 through 3: • near the bottom of three 2.0 mL sample cups (one probe per cup) • near the bottom of three small sample tubes (one probe per tube) Note: Do not push the probes against the bottom of the sample containers.
Page 361 As-Needed/As-Required Maintenance Washing All Cuvettes With System Wash Step Action This procedure is accessed by selecting: • the Utils icon from the menu bar, • <2> Maintenance, • <6> Wash All Cuvettes. Follow all instructions listed on the screen. Select <Continue> to perform the procedure. If desired, you may exit this procedure at any time before it is completed by selecting: •...
Page 362 As-Needed/As-Required Maintenance Washing CC Reagent Cuvettes with CCWA Washing CC Reagent Cuvettes with CCWA CC Reagent Wash All Cuvettes is an automated procedure that cleans all the cuvettes on the Reaction Carousel using a cartridge filled with cleaning solution. This procedure should be performed on dirty cuvettes that require additional washing beyond the Washing All Cuvettes procedure.
Page 363 As-Needed/As-Required Maintenance Cleaning the Work Surfaces Step Action , continued Exit Maintenance menu. NOTICE To resume autoprime and return system to Standby, exit the Maintenance menu. (2 of 2) Cleaning the Work Surfaces Clean all exposed working surfaces and covers that may have contacted sera or other biological fluids.
Page 364 As-Needed/As-Required Maintenance Sample Rack Decontamination Sample Rack Decontamination Clean sample racks as needed to decontaminate. Step Action Prepare a 10% bleach solution (one part sodium hypochlorite 5.25% and nine parts deionized water). Use within 24 hrs. Using a large container or sink, immerse all sample racks in the bleach solution.
Page 365 As-Needed/As-Required Maintenance Decontaminating the Instrument Step Action , continued Open the lower, middle compartment door; release latch (1) on the hydropneumatics drawer and pull out the hydropneumatic system. A016466P.EPS Figure 10.79 Remove the Wash Concentrate bottle (1), the DI Water Reservoir canister (2), and the DI Water canister (3) from the system.
Page 366 As-Needed/As-Required Maintenance Decontaminating the Instrument Step Action , continued Empty the canisters. Then fill the canisters and the empty Wash Concentrate bottle with a 10% bleach solution about two-thirds full. Install both canisters with the 10% bleach solution back onto the system using the spanner wrench tool, if necessary.
Page 367: Cts Wick Replacement Procedure
CTS Wick Replacement Procedure Introduction CTS Wick Replacement Procedure Introduction This procedure applies to the UniCel DxC 600/800 and the UniCel DxC 600i Systems with the Closed Tube Sampling (CTS), 1-Blade Thick Option. The wick is found within the Cap Piercer Assembly. The Cap Piercer wick and blade are normally replaced every two months during scheduled maintenance.
Page 368 CTS Wick Replacement Procedure System Preparation System Preparation The Cap Piercer Blade must be lowered before the Wick is replaced. Perform the following steps: Step Action Select the Utils icon from Main menu bar. Select <2> Maintenance. Select <1> 1-Blade Thick CTS Blade Replacement. Select <Continue>.
Page 369 CTS Wick Replacement Procedure Remove the Blade Assembly and Wick Clip Assembly Remove the Blade Assembly and Wick Clip Assembly The Cap Piercer Assembly is now visible as shown in Figure 10.82. Remove the Blade Assembly and Wick Clip Assembly as follows: Step Action Refer to...
Page 370 CTS Wick Replacement Procedure Remove the Blade Assembly and Wick Clip Assembly Step Action Refer to Figure 10.83. Lift the Blade Assembly (1) straight up as shown. Note: The Blade Holder Assembly includes the Blade Holder and the Blade. CAUTION The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids.
Page 371 CTS Wick Replacement Procedure Remove the Blade Assembly and Wick Clip Assembly Step Action Remove the old Wick Clip Assembly (1) from Wash Tower (2) by lifting up on both sides of Wick Clip as shown in Figure 10.84. Make sure that the old Wick is retained within the Wick Clip.
Page 372 CTS Wick Replacement Procedure Clean the Blade Clean the Blade It is recommended to clean the Blade at or near the instrument. If required, use the tray to carry blade/wick items to other locations. Clean the Blade as follows: Step Action Refer to Figure...
Page 373 CTS Wick Replacement Procedure Clean the Blade Step Action Refer to Figure 10.86. Wipe the Blade with a cotton-tip applicator as shown. CAUTION The points on the end of the Blade are very sharp and have been exposed to potentially biohazardous fluids. To prevent possible injury or exposure, avoid the Blade area.
Page 374 CTS Wick Replacement Procedure Lubricate the New Wick Lubricate the New Wick It is recommended to lubricate the Wick at or near the instrument. If required, use the tray to carry blade/wick items to other locations. Refer to Figure 10.87 during the following steps: Step...
Page 375 CTS Wick Replacement Procedure Install the Wick Clip Assembly and Blade Assembly Install the Wick Clip Assembly and Blade Assembly Install the Wick Clip Assembly and Blade Assembly as follows: Step Action Install Wick Clip Assembly (1) onto Wash Tower (2). Make sure both ends of the Wick Clip are secured.
Page 376 CTS Wick Replacement Procedure Install the Wick Clip Assembly and Blade Assembly Step Action , continued For a DxC 600/800 system, place the rack into the autoloader with no sample programming. Press the RUN button to pierce the tube caps. Inspect the bottom of each cap to confirm that the cap was pierced.
Page 377: Chapter 11 System Status And Commands
Overview Introduction CHAPTER 11 System Status and Commands Overview Introduction The System Status, Instrument Commands, and Help features provide real-time summaries and control of essential instrument components. UniCel DxC Systems Instructions For Use A13914 System Status and Commands October 2005 Page 11-1...
Page 378: System Status
Status Summary Introduction System Status Status Summary Introduction Status Summary provides a high level summary of the status of the system temperatures, power, hydropneumatic, and ICS/Smart Module components on a real- time basis in that all parameters are updated every eight seconds. Cycle count information and cuvette cleanliness data are also provided.
Page 379 Status Summary What to Do If There is an Error What to Do If There is an Error If any of the monitored areas show a Warning or Error status, select the local function key for that area. This will show each parameter for the monitored area and will indicate the specific parameter that is out of limits.
Page 380: Status-Cycle Count
Introduction The Status-Cycle Count provides an approximation of an instrument's usage. This information can be useful for estimating maintenance frequencies or anticipating component failure. Cycle counts may be periodically collected by Beckman Coulter using the instrument modem. Displaying Cycle Count...
Page 381: Temperatures
Temperatures Introduction Temperatures Introduction The actual temperature of each of the various components is shown along with: • the valid range. • an indication of when a parameter is out of limits. A yellow highlight indicates a warning condition and a red highlight indicates an error condition.
Page 382: Power Subsystems
Power Subsystems Introduction Power Subsystems Introduction Status for the Power Subsystem shows: • the actual voltage for each power distribution bus with the valid range. • the status of the power supplies, peltiers and fans. • an indication of when a parameter is out of limits. A yellow highlight indicates a warning condition.
Page 383: Hydropneumatics Subsystem
Hydropneumatics Subsystem Introduction Hydropneumatics Subsystem Introduction Status for the Hydropneumatics Subsystem shows the status for all of the reservoirs, canisters, and sumps. A yellow highlight indicates a warning condition and a red highlight indicates an error condition. The following parameters are shown: •...
Page 384: Ics/Smart Modules
ICS/Smart Modules Introduction ICS/Smart Modules Introduction ICS/Smart Module status monitors the power to the Smart Modules and the ability to communicate to and from the Smart Module. Should the Smart Module lose power or the ability to send or receive messages, an error appears. Displaying ICS/Smart Module Status Follow the steps below to view the status of instrument components (e.g., Reagent Probe, cup modules).
Page 385: Cuvette Water Blank Status
Cuvette Water Blank Status Introduction Cuvette Water Blank Status Introduction As a maintenance and troubleshooting aid, the Cuvette Status feature shows the absorbance values for all 125 cuvettes at each of the 11 wavelengths available on the system (10 for the Photometer and 1 for the LPIA Module). The system derives the data from absorbance values obtained during automatic water blank tests, which are part of cuvette washing.
Page 386: Cts Tracking
CTS Tracking Introduction CTS Tracking Introduction The CTS Tracking feature is used with DxC instruments that have the 1-Blade Thick CTS option. It makes sure that a sample tube is only pierced one time. This feature operates when up to four DxC instruments are connected in a network. Note: If notified that CTS Tracking is lost, remove the cap of a sample tube before moving it to another instrument.
Page 387: Instrument Commands
Instrument Commands Summary Introduction Instrument Commands Instrument Commands Summary Introduction Instrument commands are high level system commands that are used to control the instrument and printer. Commands Select the Instr Cmd icon from the menu bar. The following commands are available: •...
Page 388: Home
Home Introduction Home Introduction Home is used to move mechanical assemblies to a known "home" position and primes the system. Why Use Home Home is useful in the following situations: • to attempt recovery from a motion error. • to return the system or one component of the instrument from a Stopped state to Standby.
Page 389: Pause
Pause Introduction Pause Introduction Pause provides a way to prevent new tests from being started without wasting sample or reagent as pressing STOP does. Those tests that already had reagent pipetted will run to completion, but no new tests will be scheduled. This feature can pause the MC side, the CC side or both the MC and CC sides of the instrument.
Page 390 Pause When NOT to Use Pause When NOT to Use Pause Do not use Pause when there is danger involved or when the situation can be handled with another function. Table 11.3 Alternatives Instead of Pause for Some Situations Situation... Instead of Pause...
Page 391: Stop Print
Stop Print Introduction Stop Print Introduction Stop Print will stop print requests that are still in the print queue and prevent them from being sent to the printer. This feature is useful in stopping print requests composed of many pages, such as the entire Event Log, some QC reports, or preventing multiple print requests.
Page 392: Shutdown
Shutdown Introduction Shutdown Introduction Shutdown is used to place the system into a state where it is safe to reset or turn power off. System files are closed to prevent data corruption. NOTICE When performing a shutdown, it is very important to read and follow the instructions on the screens.
Page 393 Shutdown On/Off Switch On/Off Switch The circuit breaker/power ON/OFF switch is located behind the front right-hand door of the instrument. (Refer to Figure 11.1.) A016487P.EPS 1. ON/OFF switch Figure 11.1 ON/OFF Switch Line Converter Device All power to the instrument is passed through the line converter device located in the lower right compartment of the instrument.
Page 394 Shutdown Power Cord Connections Power Cord Connections Power is connected to the instrument through the intermediate three-wire power cord with special twist lock connectors. One end of the connector plugs directly into the back panel receptacle of the instrument while the other end plugs into the appropriate laboratory outlet.
Page 395: System Power On/Boot
System Power On/Boot Introduction System Power On/Boot Introduction The first software routine executed from a power-on or reset condition is the boot-up. Boot software places the instrument into a functional state by performing system initialization, running boot diagnostics, and loading the operating system. Power Up Sequence The following table describes the power-up sequence often referred to as a hard (or cold) boot.
Page 396 System Power On/Boot Reset Reset For instructions on performing a reset (or reboot) refer to Shutdown, in this chapter. System Status and Commands UniCel DxC Systems Instructions For Use A13914 Page 11-20 October 2005...
Page 397: Pause/Resume Waste B
Pause/Resume Waste B Introduction Pause/Resume Waste B Introduction The Waste B option allows for some of the waste to be collected in an external bottle instead of going immediately down the drain. It is only necessary to use the Pause Waste B option if your system is configured with a Waste B collection bottle.
Page 398: Enable/Disable Modules
Enable/Disable Modules Introduction Enable/Disable Modules Introduction Enable/Disable allows the user to Enable and Disable an individual subsystem module, the MC side, or the CC side. This function allows some subsystems to operate while others are disabled due to error conditions. Additional Information The user can manually enable or disable the following items: •...
Page 399 Enable/Disable Modules Disable Modules NOTICE When a module is Enabled, the system will go to Standby as it prepares for a prime. The system will not accept work requests at this time. Reagents should be reloaded when a module is Enabled to ensure that fresh reagents are used for subsequent testing.
Page 400: Unload All
Unload All Introduction Unload All Introduction Unload All is used when the instrument is in Standby or Stopped. It removes all the sample racks, from the sample carousel, to the offload track. It can be used: • when access to a sample is required or •...
Page 401: Chapter 12 Utilities
Overview Introduction CHAPTER 12 Utilities Overview Introduction The Utilities option provides the software tools to prime hardware subsystems and to prepare them for proper system readiness. Utilities can also be used to program the instrument for maintenance, to perform diagnostics and alignments, to view the Event Log, to back up and restore data, and to track reagent metering.
Page 402: Prime
Prime Introduction Prime Introduction The Prime feature of the Utilities menu permits the user to manually request a prime. An entire subsystem can be primed. A prime can also be requested on an individual component (refer to the tables below). This feature is only available when the system status is in Standby.
Page 403 Prime Accessing Prime Table 12.4 A Prime for Other Components of the MC Subsystems MC Subsystems Function ISE Module (all) Primes all reagents used by the ISE module. Electrolyte Buffer Primes the CO electrodes with Alkaline Buffer Reagent. Electrolyte Reference Primes both Electrolyte Reference and CO Acid Reagent.
Page 404 Prime Priming All Subsystems Priming All Subsystems If the entire group of subsystems, such as all Cartridge Chemistry (CC) subsystems, needs to be primed, it is easiest to simply select the group of subsystems for prime instead of having to select each individual subsystem. Follow the steps below to prime a group of subsystems.
Page 405 Prime Priming Hydropneumatic Subsystems Step Action From the Utilities dialog box, select <1> Prime. Type 1 in the Option Number field and press [Enter]. Select CC [F2]. Select one or a combination of the following check boxes: • Reagent Delivery Subsystem •...
Page 406 Prime Priming MC Subsystems Priming MC Subsystems MC Subsystem Prime allows the priming of the cup modules, the ISE flow cell and EIC, and the Sample Delivery Subsystem. • If a cup selection is made and neither reagent or DI water is specified, only DI water will be primed into the cup.
Page 407: Maintenance
Maintenance Maintenance Maintenance Maintenance Maintenance is routine instrument cleaning and replacement of parts as they become worn. Proper maintenance is essential for optimal instrument performance. Additional Information Refer to the CHAPTER 10, Maintenance in this manual for maintenance instructions. UniCel DxC Systems Instructions For Use A13914 Utilities October 2005 Page 12-7...
Page 408: Event Log
Event Log Introduction Event Log Introduction The Event Log is a record of events and errors that are logged (e.g., CAU: DI Water Canister Level Low. Message ID 0x01FA000E.). This logged information can be used as a troubleshooting tool if a problem is encountered while operating the instrument.
Page 409 Event Log Event Information Event Information Table 12.7 Information in the Event Log Event information Definition Number Sequential number identifying the "order", with number one representing the most recent entry. Class Number corresponding to the 1-10 event classes listed on the Event Log main screen (e.g., Instrument Events).
Page 410 Event Log Displaying Events Table 12.8 Event Classes Information Options , continued Option Description Print For creating a paper copy. Note: To save paper, before selecting <Print>, verify that only the desired event classes for the appropriate time period are selected.
Page 411 Follow the steps below to copy the Events to a disk. Copy will create a new file called elog1 without deleting other files on the diskette. The file can then be opened using a word processing or spreadsheet program or can be sent to Beckman Coulter for further investigation.
Page 412 Event Log Specifying Date/Time Specifying Date/Time It is possible to select a date and time range to show only data from that time period. This specification can be used alone to view all events for the specified date and time range or can be combined with Class selections to view only those events which occurred for selected classes during the specified date and time range.
Page 413 Event Log Printing an Event Log Printing an Event Log The Print option will send the data in the currently selected classes and date/time range to the printer. If no selections are made, the entire Event Log will be printed. Print is available from both the Main Event Log screen without having to view the data first, or can be selected from the Event Log screen.
Page 414: Alignment/Diagnostics/Pvts
Alignment/Diagnostics/PVTs Diagnostics and Alignment Alignment/Diagnostics/PVTs Diagnostics and Alignment • Diagnostics are tests used to confirm or isolate instrument problems. • Alignment allows for adjustment of the various mechanical components. • PVTs are Performance Verification Tests used to assess instrument performance. Additional Information Refer to the UniCel DxC Synchron Clinical Systems Reference Manual to access diagnostic testing procedures and alignment instructions.
Page 415: Metering
Metering Reagent Metering Metering Reagent Metering Reagent Metering provides reagent dispense counting and replenishment adjustments for those instruments that are on a cost-per-test contract. Metering is only initialized on those instruments with a cost-per-test contract. Metered-Use Instruction Manual Refer to the Synchron Clinical Systems Metered-Use Manual for instructions on usage.
Page 416: Modem
Modem The modem attached to the system provides the ability to electronically retrieve instrument data and transmit it to Beckman Coulter. Currently, there is no configuration required for the modem. Therefore, this option is grayed out. The modem is automatically initialized upon instrument reboot.
Page 417: Backup/Restore
Backup/Restore Introduction Backup/Restore Introduction The Backup/Restore option provides the ability to store data to a floppy disk for use at a later time, should an error occur that causes the loss of data. Backup is the process of saving data to a diskette for safe storage. Restore takes previously backed up data from a diskette and places it back into the system.
Page 418 Backup/Restore Restoring the System Step Action , continued When prompted, insert a diskette into the floppy disk drive. If both System Parameters and Alignment Data Files are selected, the Alignment information will be copied first. CAUTION Selecting <OK> will prepare the floppy disk by ERASING it before copying data.
Page 419 Backup/Restore Restoring the System Step Action From the Utilities dialog box, select <8> Backup/Restore. Type 8 in the Option Number field and press [Enter]. Select the System Parameters box AND/OR Select the Alignment Data Files box. Select <Restore>. Select <Cancel> to exit without restoring. Insert the backup diskette into the floppy disk drive.
Page 420: Touch Screen Calibration
Touch Screen Calibration Introduction Touch Screen Calibration Introduction Touch Screen Calibration adjusts the system so that a screen touch results in the selection of the correct item. Perform touch screen calibration when: • the touch screen is first installed, • the monitor is moved (especially higher or lower), or •...
Page 421: Chapter 13 Troubleshooting Calibration And Result Errors
Calibration Errors Introduction CHAPTER 13 Troubleshooting Calibration and Result Errors Troubleshooting Calibration Errors Calibration Errors Introduction The following pages contain descriptions of calibration reports for linear, non-linear, electrolyte module, and cup module chemistries and explanations of what each field on the report is used for when calibrating each chemistry type. Calibration Error Checking Calibration and Result Error checking is used to flag system and reagent issues.
Page 422 Calibration Errors Calibration Error Flags Table 13.1 Calibration Error and Remarks , continued Printed Flag Remarks on Report Description OCR LOW Calibration failed Response out of range low. RECOVERY Calibration failed Recovery error SENSITIVITY Calibration failed Sensitivity error SEV RECOVERY Calibration required Severe recovery error SEV SENSITVITY...
Page 423: Mc Calibration
MC Calibration Overview MC Calibration Overview The DxC calibrates MC chemistries using two or three calibrator levels. Four replicates are assayed per calibrator level. Of the four replicates, only the two middle values are used to set calibration. The highest and lowest values are discarded. The analog signals generated by the calibrator measurements are converted to digital form (ADC values).
Page 424 MC Calibration Sample/Reference Deviation Table 13.2 Digital-to-Analog Conversion (DAC) Check Limits Chemistry DAC Limits High 5400 -5900 -900 -2300 2700 -30000 -20000 CALC -125 4875 Sample/Reference Deviation • The Sample and Reference deviation error checks are used as a measure of noise for electrolytes.
Page 425 MC Calibration Calibration Reports Calibration Reports The Calibration Report can be a useful tool for identifying issues. Table 13.4 below defines the Fields in the order they are shown for each chemistry on a typical ISE Module Calibration Report. Table 13.4 ISE Module Calibration Report Field Definitions Field Description...
Page 426 MC Calibration Calibration Reports Table 13.4 ISE Module Calibration Report Field Definitions , continued Field Description Failed Calibration Log The fields listed below categorize information about a (ERR) failed calibration. Multiple errors are shown here for any chemistry failure. The errors should correlate with any of the asterisked (*) fields listed within the calibration report.
Page 427 MC Calibration Calibration Reports Table 13.5 Cup Module Calibration Report Field Definitions , continued Field Description Failed Calibration Log The fields listed below categorize information about a (ERR) failed calibration. Multiple errors are shown here for any chemistry failure. The errors should correlate with any of the asterisked (*) fields listed within the calibration report.
Page 428: Linear Calibration
Linear Calibration Overview Linear Calibration Overview For all linear photometric chemistries, the UniCel DxC sets calibration based on two or four calibrator replicates. • For calibrations using four replicates, the instrument will determine and discard the highest and lowest values of the four replicates. The remaining two values are called the usable calibrator replicates.
Page 429 Linear Calibration Span Span • Span is a measure of the sensitivity of the reagent and verifies that two consecutive calibrator levels values are a minimum distance apart. • The difference between two consecutive calibrator rates or absorbances must exceed the minimum limit or the reagent fails calibration.
Page 430 Linear Calibration Linear Calibration Report Table 13.6 CC Linear Calibration Report Field Descriptions , continued Field Description Recovery The value obtained when the final absorbance of each of the replicates used is multiplied by the determined Calibration Factor. This is the value that would be obtained if the calibrator was run as a sample using this calibration.
Page 431 Linear Calibration Linear Calibration Report Table 13.6 CC Linear Calibration Report Field Descriptions , continued Field Description Error Flag Magnitude BLANK RATE absolute delta BLANK ABS absolute delta RXN RATE absolute delta RXN ABS absolute delta INT ABS HI actual value INT RATE HI actual value BACK TO BACK...
Page 432: Non-Linear And Multipoint Calibrations
Non-Linear and Multipoint Calibrations Overview Non-Linear and Multipoint Calibrations Overview Non-linear chemistries include drugs and specific protein assays. The calibration curves for non-linear calibrations are logarithmic or have other non-linear relationships. Non-linear chemistry calibrations may have single level or multilevel calibrators. •...
Page 433 Non-Linear and Multipoint Calibrations Recovery Recovery The Recovery Flag determines whether recovery errors for each calibration level are too large for a calibration to be useful. The difference between the recovered concentration and the actual concentration exceeds specification. This error is overrideable.
Page 434 Non-Linear and Multipoint Calibrations Calibration Report Calibration Report The CC Non-Linear and Multipoint Calibration Reports can be a useful tool for identifying issues. Table 13.7 below provides definitions of specific calibration fields found on those two reports. Table 13.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions Field Description...
Page 435 Non-Linear and Multipoint Calibrations Calibration Report Table 13.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions , continued Field Description Curve Parameters (Ro, Kc, R, Conc, a, b, c) Positioning and scaling factors for curve determination. • Ro – Calculated response for a zero sample •...
Page 436 Non-Linear and Multipoint Calibrations Calibration Report Table 13.7 Non-Linear Single Point and Multipoint Calibration Reports Field Definitions , continued Field Description Error Flag Magnitude BLANK RATE absolute delta BLANK ABS absolute delta RXN RATE absolute delta RXN ABS absolute delta INT ABS HI actual value INT RATE HI...
Page 437: Troubleshooting Result Errors
Result Errors Introduction Troubleshooting Result Errors Result Errors Introduction All reactions are checked against chemistry parameter flag limits (e.g., absorbance limits, reference ranges) to qualify the reagent, calibration, or sample. Checks are performed against the final result and on interim reaction data for all samples, including calibrators.
Page 438: Error Codes And Definitions
Result Errors and Codes Error Codes and Definitions Result Errors and Codes Result errors and codes are printed on the report. Table 13.9 below provides descriptions of those codes. Table 13.9 Result Errors and Codes Result Displayed on Report Printed in Host Inst.
Page 439 Result Errors and Codes Table 13.9 Result Errors and Codes , continued Result Displayed on Report Printed in Host Inst. Description Remarks Area Code Code DIVISION ERROR Division Error – Special calculation divisor is zero. HI REAGENT MC reagent level high. INCOMPLETE Calculation incomplete.
Page 440 Result Errors and Codes Table 13.9 Result Errors and Codes , continued Result Displayed on Report Printed in Host Inst. Description Remarks Area Code Code Results Suppressed INI RATE LO CC chemistries, initial rate too low. MC chemistries, a stirrer failure. Results Suppressed INIT ADC HI Initial ADC error high.
Page 441: Error Code – Definitions
Error Code – Definitions Antigen Excess Error Code – Definitions Antigen Excess A chemistry failed antigen excess test for immunoprotein reagents. This flag may indicate a contaminated cartridge. Bad K/NA Value K or NA are required to calculate a CALC result. Should one or the other fail or have an error, CALC cannot be calculated and this error is reported.
Page 442 Error Code – Definitions Calibration Overridden Calibration Overridden Chemistry result was calculated with an overridden calibration value. The calibration should be verified as valid before reporting the result. Calibration Time Extended Chemistry result was calculated with a calibration value from an expired calibration which had been extended.
Page 443 Error Code – Definitions Exceeds Reference Range Low/High Exceeds Reference Range Low/High Result exceeds operator defined reference ranges in reference range setup. Please refer Reportable Ranges Setup in CHAPTER 4, System Setup Options in this manual for additional information. Excessive Reference Drift – Sample to Calibration The reference value for an ISE sample measurement drifted from the reference value of the calibration and exceeded the limit.
Page 444 Error Code – Definitions Initial ADC Error High/Low Initial ADC Error High/Low The ADC value determined from the first read after reagent addition has exceeded specifications. This is a measure of modular cup reagent or cup integrity. This flag may be triggered if using old, contaminated or poorly prepared reagents, or when a cup chemistry fails to empty properly, leaving a dirty reaction cup.
Page 445 Error Code – Definitions Less Than X-ORR LO Less Than X-ORR LO Calculated result is less than the lower Reportable Range. Result is not reported. Level Sense Error in Diluent Cartridge A Level Sense Error occurred in the diluent cartridge and the system was unable to perform the required dilutions.
Page 446 Error Code – Definitions Out of Instrument Range High/Low Out of Instrument Range High/Low The recovered value exceeds the value that the instrument will report. Out of ORDAC Range High/Low A reaction exceeded the range of ORDAC (Over Range Detection and Correction) values that the instrument will report.
Page 447 Error Code – Definitions Reaction Noise (Mean Deviation) Reaction Noise (Mean Deviation) The average difference between the reaction absorbance readings and the line of regression is greater than allowed. This checks for constant noise during the spin cycle. This flag may indicate possible issues with a photometer reading. Also, results below the low end of the analytical range may trigger the RXN NOISE flag.
Page 448 This error occurs when a result does not fit into a specific calibration curve. Rerun the sample for verification. This error may indicate sample interference issues. It may also indicate issues with photometer performance. Contact Beckman Coulter Technical Support for additional information.
Page 449: Common Error Messages And Corrective Actions
0x01F90005 No operator action is necessary. Subsystem: Consistent messages may indicate issues PWRMGR with: Temperature: • the Thermister • the Thermister cable • the Power Control Board • the Peltier Assembly Contact Beckman Coulter Technical Support Center for additional information.
Page 450 • Press the STOP button and HOME the 0x01FA0004 canister is full, which is considered system. a flood for this canister. • Contact Beckman Coulter Technical Support Center for additional information. 0x01FA0006 Flood In Primary CAU: Flood In Primary Description: This error will occur •...
Page 451 • Make sure Instrument is not rolled on 0x01FA0008 for the sump. top of the Drain Line. • If the error continues, Contact Beckman Coulter Technical Support Center for additional information. 0x01FA0009 DI Water Canister CAU: DI Water Description: Whenever the DI •...
Page 452 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x01FA000B Wash Concentrate CAU: Wash Description: Wash Concentrate • Load a new bottle of Wash Reservoir Is Not Concentrate Reservoir Is Reservoir Is Not Filling At All.
Page 453 • Make sure caps on pressurized bottles are tight. • Make sure Vacuum Accumulator canister in the rear of the Hydro is empty. • Contact Beckman Coulter Technical Support Center for additional information. 0x01FA0019 10 PSI Air Supply CAU: 10 PSI Air Description: This error occurs •...
Page 454 17 psi. Finally, adjust the low pressure system. The pressure range for the low pressure system is 8–11 psi. Set it at 10 psi. • Contact Beckman Coulter Technical Support Center for additional information. 0x01FA001C 17 psi air supply...
Page 455 0x02620017 • Make sure Wash Tower is properly Subsystem: RASched seated and aligned to cuvettes. Action Name: action • Press the STOP button and HOME the name system. • Contact Beckman Coulter Technical Support Center for additional information.
Page 456 • If the CC sample probe is responsible, perform the appropriate vertical or horizontal alignment. • If the Syringe is responsible, check for proper seating of syringe assembly. • Contact Beckman Coulter Technical Support Center for additional information.
Page 457 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x0262001A CC Sample Probe CAU: CC Sample Probe Description: This error occurs • No operator action is necessary Obstruction Obstruction when the CC sample probe ODC...
Page 458 • If event log indicates a vertical error, make sure the reagent cartridges on the carousel are pushed in and seated properly. • Perform the appropriate vertical or horizontal CC reagent Probe A alignment. • Contact Beckman Coulter Technical Support Center for additional information.
Page 459 • If event log indicates a vertical error, check that the reagent cartridges on the carousel are pushed in and seated properly. • Perform the appropriate vertical or horizontal CC reagent Probe B alignment. • Contact Beckman Coulter Technical Support Center for additional information.
Page 460 Switch Motion Error whenever there is a motion error in system. Message ID: the Reagent Switch (A/B valve). • Contact Beckman Coulter Technical 0x02620021 This error does not occur during a Support Center for additional Subsystem: RASched home, only runtime, primes, etc.
Page 461 • HOME and restart the system. or vertical motion error. • If mixer appears out of position, perform rotary or vertical alignment. • If motion error continues, contact Beckman Coulter Technical Support Center for additional information. 0x02620025 CC Sample Syringe CAU: CC Sample Description: This error occurs •...
Page 462 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x02620033 10 Cuvettes Have CAU: 10 Cuvettes Have Description: This error can be • Remove wash station head and inspect failed Water Blank Failed Water Blank flagged for the following:...
Page 463 Consistent messages may indicate issues with the level sense function of: • reagent probe bead assembly • reagent probe alignments • level sense board Contact Beckman Coulter Technical Support Center for additional information. 0x0262003A CC Sample Probe CAU: CC Sample Probe Description: Multiple samples had •...
Page 464 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x0262003F Too many tubes not CAU: CC Sample Probe Description: Multiple tubes had • Check cap piercer for broken blade. venting correctly, disabled due to Excess excessive vacuum in thick stopper...
Page 465 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x02680001 CC Sample Level CAU: CC Sample Level Description: This error occurs • Check sample for adequate volume Sense Error Sense Error under following conditions:...
Page 466 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x02680003 Sample tube did not CAU: CC Sample Tube Description: Probe detected • Uncap tube and rerun. vent correctly.
Page 467 0xcommand, Error Error Msg: error There are several types of subsystem errors. Number: 0xerror message Photometer Smart Module (PSM) • Contact Beckman Coulter Technical number. Command: 0xcommand errors. Support Center for additional Error number: 0xerror If for any reason the instrument information.
Page 468 • Make sure CC Sample Probe tubing is sample aspiration. If it does not see properly connected at top of Probe. the correct differential, it will flag a • Contact Beckman Coulter Technical transducer error. Support Center for additional information.
Page 469 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x03880006 CC Reaction CAU: cc rwHtr reaction Description: This error occurs • Check System Status for Reaction Carousel wheel temp out of range under the following conditions:...
Page 470 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x04B2001E MC Sample Probe CAU: MC Sample Description: This error occurs • No operator action is necessary. Obstruction Probe Obstruction when the MC sample probe ODC...
Page 471 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x04B20026 Sample tube did not CAU: MC Sample Tube Description: Probe detected • Uncap tube and rerun. vent correctly.
Page 472 • Failure to drain is either caused by low Chem Name: chem Cup: chem id vacuum or a valve failure. • Contact Beckman Coulter Technical Support Center for additional information. 0x04B30011 MC Reagent Level Chem Name: Description: This error occurs •...
Page 473 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x04B30013 MC Sample Probe CAU: MC Sample Description: More than 3 samples • Prime MC internal probe wash to make disabled due to Probe disabled due to in a row had obstruction errors...
Page 474 - If on Main Screen, and the rack is physically present, shuttle latch may not have hooked the rack properly. Contact Beckman Coulter Technical Support Center for additional information. • If this error occurred during a rack unload, check the results for the samples in the misread rack.
Page 475 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x057A0009 Duplicate Rack ID CAU: Duplicate Rack Description: This error occurs • Compare the number of the rack that rack # during a load when a rack ID is read was rejected with the racks currently...
Page 476 • If tubes have been re-capped, make sure caps are fully seated in the tube. • If error continues perform cap piercer tube height alignment. • Contact Beckman Coulter Technical Support Center for additional information. 0x057A000E Rack Height Not...
Page 477 • Perform the appropriate vertical or "RaiseRgtMixer" – error horizontal CC reagent mixer occurred during a vertical alignment. movement toward the home • Contact Beckman Coulter Technical sensor flag. Support Center for additional • "HomeRgtMixerVer" – error information. occurred during a vertical movement away from the home sensor flag.
Page 478 • Check Event Log for specific • Both decks flag sensors. RGTWHL subsystem errors. • The magnetic door sensor. • Contact Beckman Coulter Technical Support Center for additional information. 0x05DC01FD CC Sample Mixer CAU: Homing Error: $s Description: This motion error is •...
Page 479 • If error continues after HOME, print they jam, the error will be flagged. screen and check event log for specific sub-system homing error, and contact Beckman Coulter Technical Support Center for additional information. 0x05DC0200 CC Subsystem CAU: Homing Error for Description: This is a generic •...
Page 480 0x05DC01202 side in the homing routine. This • Reboot system. error has several different triggers • Contact Beckman Coulter Technical ranging from motion issues to Support Center for additional "Attach" and download failures. information. • If the event log parameter is...
Page 481 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x05DC0227 No Response From CAU: Homing Timeout Description: This error occurs • Check Event Log for specific Hydro Subsystem for Hydro Subsystem.
Page 482 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x139D0044 Date May Be Out SS: date/time was set Description: Information to user • No operator action is necessary. Be Of Order Due to backwards from that changing system date or time...
Page 483 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x139F0039 Reagent Cartridge STM: Reagent container Description: Specified reagent • Prepare to load another cartridge if has less that 5 tests has less than 5 tests left: cartridge has less than 5 tests another is not already on-board.
Page 484 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x139F0068 CTS Tracking STM: TS-CTS Tracking Description: This error will occur • If a networked system has been Information can System disconnect whenever 1 or more instruments is...
Page 485 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x139F0069 Full CTS Tracking STM: TS-CTS Tracking Description: All of the systems that • No operator action is necessary. is now available.
Page 486 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13A00023 QC Database is WLM: QC DB is full. Description: QC database is full. • Archive QC so that additional data will full.
Page 487 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13A00057 Required levels for WLM: Subsequent Description: Not all calibrator • Reload calibrator racks. calibrator not calibrator levels not levels were loaded or were loaded •...
Page 488 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13A00092 Sample Programs WLM: Sample Description: Sample programming • Clear the existing sample program and are too old on rack: programs too old –...
Page 489 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13A50024 Host HC: Host Port Description: A problem sending • Check the LIS for status. Communication Communication Error data out the host port has been •...
Page 490 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13A70005 Instrument not in ICMD: Can't do HOME Description: System is not in • Wait for the system to get to Standby/ proper state.
Page 491 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13AC0016 Automatic smart BOOT: Automatic Description: After new software is • No operator action is necessary. module download: smart module download: loaded, new software was smart modules.
Page 492 Common Error Messages and Corrective Actions Table 13.10 Error Messages and Corrective Actions , continued Pop-up Event Log Description Corrective Action Class # 0x13AD0020 No Contents file on Backup/Restore: No Description: System cannot • Use another disk if available. floppy TOC floppy file.
Page 493 • Check Ethernet cable connection at Instrument cauman/ has been lost and the computer console, microhub and instrument. cau_router.c:1675) console cannot communicate with • Reboot system. Message ID: the instrument. • Contact Beckman Coulter Technical 0x1391000E Support Center for additional information.
Page 495 Analytical ranges are internal system limits used to set the high and low measuring limits of the system. These are the ranges that Beckman Coulter has verified can be achieved by the system. The ranges for each analyte can be found in the Synchron Clinical Systems Chemistry Information Manual.
Page 496 DxC Terms Aspirated Aspirated Indicates whether an initial aspiration of the sample has been accomplished. 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.
Page 497 A character used to mathematically check that a bar code is read accurately. Chemistry List The comprehensive list of all Beckman Coulter chemistries available to the user. Chemistry Menu The collection of chemistries configured by the user from the chemistry list for display/selection in sample programming and panel configuration.
Page 498 DxC Terms Control ID Control ID The equivalent of a Sample ID for a control. A maximum of eight unique Control IDs can be defined for each Control Name. Critical Range A user-defined range consisting of low and high values that are used to flag patient results as "critical low"...
Page 499 DxC Terms Diluent Diluent Fluid used to dilute another fluid. Dilution Factor, Off-Line A factor defined by the user by which the sample result will be multiplied. Discrete The state of reactions taking place in their own separate container. Double Trigger Two different reagent components, added to the cuvette after sample addition, that initiate the desired action.
Page 500 DxC Terms File Number (QC) File Number (QC) A unique number that must be assigned to each chemistry defined for a control. Help System A Help System is available online in six supported languages (the default is English). The Help System can be accessed by selecting the Help icon ( ) on the right side of the Function Selection Icon menu.
Page 501 A laboratory host computer that can be interfaced to an DxC analyzer. Lot-Specific Parameter Card A Beckman Coulter-provided card which is imprinted with bar codes. The card allows for lot-specific calibration information to be loaded into the DxC system. LPIA Large Particle Immuno Assay Microtube™...
Page 502 DxC Terms Options Button Options Button A button on a screen or dialog box that, when selected, presents a drop-down list of items (options) from which to choose. These buttons, triangular in shape, appear beside a text field. ORDAC Over Range Detection And Correction. When enabled, this feature causes specific high test results to be rerun using a sample diluted automatically by the system or using a smaller sample volume (depending on the test being rerun).
Page 503 DxC Terms Reagent Acronym Reagent Acronym The two-to five-character abbreviation of the chemistry name. Reagent Carousel The Reagent Carousel Compartment provides an on-instrument storage area for the individual reagent cartridges. A total of 59 reagent cartridges can be stored in the carousel at one time.
Page 504 A set of programs that run a series of tests, designed to test the proper action sequence of each component of the instrument. An offline diagnostics program used by Beckman Coulter Service. Symbology, Bar Code A set of rules for encoding and decoding information contained in a bar code symbol.
Page 505 DxC Terms URDAC URDAC Under Range Detection And Correction. Specific chemistries that are below the normal analytical range will automatically be rerun with a larger sample volume. Wash Concentrate The on-board fluid used to automatically rinse the probes and cuvettes. UniCel DxC Systems Instructions For Use A13914 Glossary October 2005...
Page 506 DxC Terms Wash Concentrate Glossary UniCel DxC Systems Instructions For Use A13914 Page 12 of 12 October 2005...
Page 507 Index Numerics Calibrator set point modifications ... . . 5-30 Enzyme validator ......5-25 Error detection .
Page 508 Definition ....... . 6-4 Error detection Deleting ....... . 6-13 See Calibration Editing .
Page 509 Manual Manual ........7-8 Conventions ......1-2 Manual assignments.
Page 510 Tables ........4-11 Beckman Coulter defined chemistries ..4-11...

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